Proposed Rule: Medicare Conditions For Coverage For End-Stage Renal Disease Facilities

Friday,
February 4, 2005
Part IV
Department of
Health and Human
Services
Centers for Medicare & Medicaid Services
42 CFR Parts 400, 405, 410, et al.

Medicare Program; Conditions for
Coverage for End Stage Renal Disease
Facilities; Proposed Rule
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6184 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules
DEPARTMENT OF HEALTH AND 3. By hand or courier. If you prefer, public website. Comments received
HUMAN SERVICES you may deliver (by hand or courier) timely will be available for public
your written comments (one original inspection as they are received,
Centers for Medicare and Medicaid and two copies) before the close of the generally beginning approximately 3
Services comment period to one of the following weeks after publication of a document,
addresses. If you intend to deliver your at the headquarters of the Centers for
42 CFR Parts 400, 405, 410, 412, 413, comments to the Baltimore address, Medicare & Medicaid Services, 7500
414, 488, and 494 please call telephone number (410) 786– Security Boulevard, Baltimore,
[CMS–3818–P] 9994 in advance to schedule your Maryland 21244, Monday through
arrival with one of our staff members. Friday of each week from 8:30 a.m. to
RIN 0938–AG82 Room 445–G, Hubert H. Humphrey 4 p.m. To schedule an appointment to
Building, 200 Independence Avenue, view public comments, phone 1–800–
Medicare Program; Conditions for
SW., Washington, DC 20201; or 7500 743–3951.
Coverage for End Stage Renal Disease Copies: To order copies of the Federal
Security Boulevard, Baltimore, MD
Facilities Register containing this document, send
21244–1850.
AGENCY: Centers for Medicare & (Because access to the interior of the your request to: New Orders,
Medicaid Services (CMS), HHS. HHH Building is not readily available to Superintendent of Documents, P.O. Box
ACTION: Proposed rule. persons without Federal Government 371954, Pittsburgh, PA 15250–7954.
identification, commenters are Specify the date of the issue requested
SUMMARY: This proposed rule would encouraged to leave their comments in and enclose a check or money order
revise the requirements that end stage the CMS drop slots located in the main payable to the Superintendent of
renal disease (ESRD) dialysis facilities lobby of the building. A stamp-in clock Documents, or enclose your Visa or
must meet to be certified under the is available for persons wishing to retain Master Card number and expiration
Medicare program. The revised a proof of filing by stamping in and date. Credit card orders can also be
requirements focus on the patient and retaining an extra copy of the comments placed by calling the order desk at (202)
the results of the care provided to the being filed.) 512–1800 (or toll-free at 1–888–293–
patient, establish performance Comments mailed to the addresses 6498) or by faxing to (202) 512–2250. As
expectations for facilities, encourage indicated as appropriate for hand or an alternative, you can view and
patients to participate in their care plan courier delivery may be delayed and photocopy the Federal Register
and treatment, eliminate many received after the comment period. document at most libraries designated
procedural requirements from the Submission of comments on as Federal Depository Libraries and at
current conditions for coverage, and paperwork requirements. You may many other public and academic
preserve strong process measures when submit comments on this document’s libraries throughout the country that
necessary to promote patient well being paperwork requirements by mailing receive the Federal Register.
and continuous quality improvement. your comments to the addresses This Federal Register document is
These changes are necessary to reflect provided at the end of the ‘‘Collection also available from the Federal Register
the advances in dialysis technology and of Information Requirements’’ section in online database through GPO Access, a
standard care practices since the this document. service of the U.S. Government Printing
requirements were last revised in their For information on viewing public Office. The Web site address is: http://
entirety in 1976. comments, see the beginning of the www.gpoaccess.gov/fr/index.html.
DATES: To be assured consideration, SUPPLEMENTARY INFORMATION section. Table of Contents
comments must be received at one of FOR FURTHER INFORMATION CONTACT:
the addresses provided below, no later I. Introduction and the Provision of Reference
Robert Miller (410) 786–6797, Teresa Materials
than 5 p.m. on May 5, 2005. Casey (410) 786–7215, and Rachael II. Background
ADDRESSES: In commenting, please refer Weinstein (410) 786–6775 (Conditions A.History
to file code CMS–3818–P. Because of for Coverage and Quality Standards). Jan B. Existing ESRD Regulations
staff and resource limitations, we cannot Tarantino, (410) 786–0905 (Survey and C. Overview
accept comments by facsimile (fax) Certification). D. Establishment of Central Requirements
transmission. E. Development of Outcome-Based
SUPPLEMENTARY INFORMATION: Performance Quality Measures
You may submit comments in one of
three ways (no duplicates, please): Submitting Comments: We welcome 1. Dialysis Facility Compare
1. Electronically. You may submit comments from the public on all issues 2. Dialysis Facility Data Reporting
electronic comments on specific issues set forth in this rule to assist us in fully Requirements
considering issues and developing 3. Facility Specific Reports
in this regulation to http://
policies. You can assist us by 4. The National Kidney Foundation Kidney
www.cms.hhs.gov/regulations/ Disease Outcomes Quality Initiative
ecomments. (Attachments should be in referencing the file code CMS–3818–P
(NKF-K/DOQI) Clinical Practice
Microsoft Word, WordPerfect, or Excel; and the specific ‘‘issue identifier’’ that Guidelines
however, we prefer Microsoft Word.) precedes the section on which you 5. CMS ESRD Clinical Performance
2. By mail. You may mail written choose to comment. Measures Project
comments (one original and two copies) Inspection of Public Comments: All 6. CPM Data Reporting
to the following address ONLY: comments received before the close of 7. Updating Existing ESRD Patient-Specific
Centers for Medicare & Medicaid the comment period are available for Performance Measures and Developing
Services, Department of Health and viewing by the public, including any Future ESRD Facility Performance
personally identifiable or confidential Standards
Human Services, Attention: CMS–3818–
F. Summary of the Contents of the
P, PO Box 8012, Baltimore, MD 21244– business information that is included in Proposed Rule
8012. a comment. After the close of the III. Provisions of Proposed Part 494 Subpart
Please allow sufficient time for mailed comment period, CMS posts all A (General Provisions)
comments to be received before the electronic comments received before the A. Basis and Scope (Proposed § 494.1)
close of the comment period. close of the comment period on its B. Definitions (Proposed § 494.10)
Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6185
C. Compliance with Federal, State, and E. Governance (Proposed § 494.180) DSN Dialysis Surveillance Network
Local Laws and Regulations (Proposed 1. Existing Requirements for Governing EMS Emergency medical system
§ 494.20) Bodies ESRD End stage renal disease
IV. Provisions of Proposed Part 494 Subpart 2. Overview of the Proposed Governance FDA Food and Drug Administration
B (Patient Safety) Requirements HHA Home health agency
A. Infection Control (Proposed § 494.30) 3. Governance Condition (Proposed HIPAA Health Insurance Portability and
B. Water Quality (Proposed § 494.40) § 494.180) Accountability Act of 1996
C. Reuse of Hemodialyzers and Bloodlines 4. Designating a Chief Executive Officer or ICH In-center hemodialysis
(Proposed § 494.50) Administrator (Proposed § 494.180(a)) IOM Institute of Medicine
D. Physical Environment (Proposed 5. Adequate Number of Qualified and IT Information technology
§ 494.60) Trained Staff (§ 494.180(b)) LSC Life Safety Code
V. Provisions of Proposed Part 494 Subpart 6. Medical Staff Appointments (Proposed MedPAC Medicare Payment Advisory
C (Patient Care) § 494.180(c)) Commission
A. Patients’ Rights (Proposed § 494.70) 7. Furnishing Services (Proposed MSW Master’s degree social worker
B. Patient Assessment (Proposed § 494.80) § 494.180(d)) NANT National Association of Nephrology
C. Patient Plan of Care (Proposed § 494.90) 8. Internal Grievance Process (Proposed Technicians
1. Development of the Patient Plan of Care § 494.180(e)) NF Nursing facility
(Proposed § 494.90(a)) 9. Discharge and Transfer Policies and NFPA National Fire Protection Association
a. Dose of Dialysis (Proposed Procedures (Proposed § 494.180(f)) NIH National Institutes of Health
§ 494.90(a)(1)) 10. Emergency Coverage (Proposed NISTA National Institute of Standards and
b. Nutritional Status (Proposed § 494.180(g)) Technology Act
§ 494.90(a)(2)) 11. Furnishing Data and Information for NKF National Kidney Foundation
c. Anemia (Proposed § 494.90(a)(3)) ESRD Program Administration (Proposed NKF-K/DOQI National Kidney
d. Vascular Access (Proposed § 494.180(h)) Foundation’s Kidney Disease Outcomes
§ 494.90(a)(4)) 12. Disclosure of Ownership (Proposed Quality Initiatives
e. Transplantation Status (Proposed § 494.180(i)) NNCC Nephrology Nursing Certification
§ 494.90(a)(5)) VII. Other Proposed Changes Commission
f. Rehabilitation Status (Proposed A. Proposed Cross-Reference Changes NNCO National Nephrology Certification
§ 494.90(a)(6)) B. Proposed Additions to Part 488 Organization
g. Social Services VIII. Reference Materials NQF National Quality Forum
2. Implementation of the Patient Plan of A. New Provisions in Part 494 NTTAA National Technology Transfer and
Care (Proposed § 494.90(b)) B. ESRD Crosswalk Advancement Act of 1995
3. Transplantation Referral (Proposed C. Bibliography OBRA 1990 Omnibus Reconciliation Act
§ 494.90(c)) IX. Collection of Information Requirements 1990
4. Patient Education and Training and Public Comments OIG Office of the Inspector General
(Proposed § 494.90(d)) A. Collection of Information Requirements OMB Office of Management and Budget
D. Care at Home (Proposed § 494.100) B. Response to Comments QAPI Quality assessment and performance
1. Dialysis of ESRD Patient in the Home X. Regulatory Impact Analysis improvement
Setting Regulations Text RPA Renal Physicians Association
2. Dialysis of ESRD Patients in Nursing RRG Rapid response group
Facilities and Skilled Nursing Facilities Acronyms
SNF Skilled nursing facility
a. Delineation of Responsibility AKF American Kidney Fund VISION Vital Information System to
b. Applicable ESRD Conditions for AAMI Association for the Advancement of Improve Outcomes in Nephrology
Coverage Medical Instrumentation URR Urea reduction rate
c. Nursing Coverage ANNA American Nephrology Nurses USRDS United States Renal Data System
d. Training Association
e. Monitoring AHRQ Agency for Healthcare Research and I. Introduction and the Provision of
E. Quality Assessment and Performance Quality Reference Materials
Improvement (Proposed § 494.110) AED Automatic external defibrillator
1. Program Scope (Proposed § 494.110(a)) AIA American Institute of Architects A. Introduction
2. Monitoring Performance Improvement ANSI American National Standards The Centers for Medicare and
(Proposed § 494.110(b)) Institute Medicaid Services (CMS) is committed
3. Prioritizing Improvement Activities BBA Balanced Budget Act of 1997
to modernizing the existing regulations
(Proposed § 494.110(c)) BONENT Board of Nephrology Nursing
4. Facility Specific Standards of Examiners Nursing and Technology that are based on largely procedural
Enforcement BUN Blood urea nitrogen standards. One of our key initiatives is
F. Special Purpose Renal Dialysis Facilities CAHPS Consumer Assessment of Health to revise many of the health and safety
(Proposed § 494.120) Plans Survey conditions to focus on the patient’s
G. Laboratory Services (Proposed CBC Center for Beneficiary Choices experience with care in the delivery
§ 494.130) CDC Centers for Disease Control and setting, patient outcomes of care, and
VI. Provisions of Proposed Part 494 Subpart Prevention the elimination of unnecessary
D (Administration) CHI Consolidated Health Informatics procedural requirements.
A. Personnel Qualifications (Proposed CEO Chief executive officer
§ 494.140) CLIA Clinical Laboratory Improvement
In concert with the Administration’s
1. Medical Director (Proposed § 494.140(a)) Amendments regulatory reform initiative, we believe
2. Nursing Services (Proposed § 494.140(b)) CMS Centers for Medicare and Medicaid that new ESRD regulations should—
3. Dietitian (Proposed § 494.140(c)) Services • Be founded on evidence;
4. Social Worker (Proposed § 494.140(d)) CPG Clinical practice guidelines • Be patient-centered;
5. Patient Care Dialysis Technicians CPM Clinical performance measures • Promote outcomes desired for
(Proposed § 494.140(e)) CPR Cardiopulmonary resuscitation Medicaid and Medicare beneficiaries as
6. Other Personnel Issues CROWN Consolidated Renal Operations in
well as others served by participating
B. Responsibilities of the Medical Director a Web-enabled Network
(Proposed § 494.150) DHHS Department of Health and Human ESRD suppliers of services;
C. Relationship with the ESRD Network Services • Establish a framework for the
(Proposed § 494.160) DME Durable medical equipment collection and reporting of consensus-
D. Medical Records (Proposed § 494.170) DOQI Disease Outcomes Quality Initiative driven performance standards;
• Set clear expectations for dialysis • The Medicare conditions for based on several considerations. As
facility accountability; and coverage for suppliers of ESRD services; discussed above, revising the ESRD
• Stimulate improvements in • Certification procedures; requirements is part of our effort to
processes, outcomes of care, and • Establishment of minimal modernize regulations and move toward
beneficiary satisfaction. utilization rates; a patient outcome-based system that
In addition, the new ESRD conditions • Designation of ESRD network areas; focuses on quality assessment and
for coverage must comport with our • Establishment of Network performance improvement. We believe
national performance measurement Coordination Councils; and that revising the conditions for coverage
strategy, which consists of three • The provision of a Medical Review will encourage improvement in
principles: (1) Performance measures Board. outcomes of care for beneficiaries.
should be consumer and purchaser- A comment period lasting 60 days Secondly, the existing ESRD conditions
driven; (2) performance measures followed and comments were carefully were originally adopted in 1976 and
should be in general, commonly-used considered. On June 3, 1976 the final although some amendments have been
terms, and their associated collection rule was published in the Federal made they have not been
tools should be generally available at Register (41 FR 22501). Subsequently, comprehensively revised since that
little or no cost to dialysis facilities; and the ESRD Amendments of 1978 (Pub. L. time. The existing requirements for
(3) the content and collection of data 95–292), amended title XVIII of the dialysis facilities emphasize the policies
and performance measures derived from Social Security Act (the Act) by adding and procedures that must be in place to
that data should be standardized. section 1881. Sections 1881(b)(1) and support good patient care, and they
1881(f)(7) of the Act further authorize focus on a facility’s capacity to furnish
B. Provision of Informational and the Secretary to prescribe health and
Review Aids quality care, rather than on the actual
safety requirements (known as provision of quality care to patients and
In our development of the proposed conditions for coverage) that a facility the outcomes of that care. Third, we
rule, we have included references to a providing dialysis and transplantation wish to incorporate the most recent
number of reports, articles, and other services to dialysis patients must meet medical and scientific guidelines and
documents in the preamble. To indicate to qualify for Medicare reimbursement. recommendations for dialysis facilities
the source of this information, we have In addition, section 1881(c) of the Act from the Centers for Disease Control and
provided a brief parenthetical establishes ESRD network areas and Prevention (CDC), the Association for
acknowledgement at the end of network organizations to assure that the Advancement of Medical
referenced statement and have provided dialysis patients are provided Instrumentation (AAMI), and recognize
a full citation for the reference in the appropriate care. current practice guidelines and
bibliography (see section of VIII.C. of standards of practice such as the
this preamble). Other informational and B. Existing ESRD Regulations
National Kidney Foundation’s Kidney
review aids incorporated in this The requirements from section Disease Outcomes Quality Initiative
proposed rule include— 1881(b), (c), and (f)(7) are implemented (NKF-K/DOQI) clinical practice
• A table of contents; in regulations at 42 CFR 405, subpart U, guidelines (CPGs).
• A list of acronyms; Conditions for Coverage of Suppliers of The existing ESRD conditions do not
• A chart listing the new provisions End-Stage Renal Disease (ESRD) require the facility to operate a patient-
(see section VIII.A. of this preamble); Services. centered, outcome-oriented quality
and The existing regulations describe the assessment and performance
• A crosswalk of the existing health and safety requirements that improvement program. Moreover,
requirements to the proposed dialysis facilities and renal changes have taken place in the delivery
requirements (see section VIII.B. of this transplantation centers must meet to of services to dialysis patients, and
preamble). furnish care to Medicare beneficiaries. these advances are not reflected in the
II. Background The regulations in subpart U also existing requirements. Thus, we have
include the provision that dialysis concluded that significant revisions to
A. History facilities be organized into Network the conditions for coverage for ESRD
ESRD is a kidney impairment that is areas and describe the role that facilities are essential. The proposed
irreversible and permanent and requires Networks play in the ESRD program. changes reflect improvements in
a regular course of dialysis or kidney The purpose of the existing standard care practices, the use of more
transplantation to maintain life. Dialysis conditions for coverage (also known as advanced technology and equipment,
is the process of cleaning the blood conditions) is to protect dialysis and, most notably, a framework to
artificially with special equipment patients’ health and safety and to ensure incorporate performance measures
when the kidneys have failed. that quality care is furnished to all viewed by the scientific and medical
Section 299I of the Social Security patients in Medicare-approved dialysis community to be related to the quality
Amendments of 1972 (Pub. L. 92–603) and kidney transplantation facilities. To of care provided to dialysis patients.
originally extended Medicare coverage determine if a facility meets these
to insured individuals, their spouses, conditions, the State survey agency C. Overview
and their dependent children with performs on-site surveys of the facility. Since 1994, we have received
ESRD who require dialysis or If a survey indicates that a facility is in comments from the renal community at
transplantation. The ESRD program compliance with the conditions, and all large and we have used the
became effective July 1, 1973, and other Federal requirements are met, we contributions provided by the
initially operated under interim then certify the facility as qualifying for community in developing the revised
regulations published in the Federal Medicare payment. Medicare payment conditions contained in this proposed
Register on June 29, 1973 (38 FR 17210). for outpatient maintenance dialysis and rule. Several renal organizations have
In the July 1, 1975 Federal Register (40 kidney transplantation is limited to offered recommendations regarding the
FR 27782), we published a proposed facilities meeting these conditions. conditions for coverage during the
rule that revised sections of the Our decision to propose major bimonthly public 2001 and 2002 CMS
regulations relating to: changes to the existing conditions is meetings on ESRD topics. Notices of
these were announced on the CMS Web must be developed and validated with consolidation of the various aspects of
site (http://www.cms.hhs.gov/opendoor/ community input to ensure they are home dialysis care into a single
schedule.asp). We believe that many in clinically meaningful and reflect current condition (care at home).
the community support the overall shift scientific knowledge. Subpart D (administration) covers the
in the proposed conditions from an operation of the dialysis facility in a
D. The Establishment of Central patient outcome-oriented environment,
emphasis on process-oriented
Requirements including: (1) Minimum personnel
requirements to a more patient-centered,
outcome-oriented approach. Further, we We are proposing new conditions for qualifications; (2) the role of the medical
believe that virtually all members of the coverage for ESRD facilities that revise director; (3) the facility’s relationship
community support a quality or eliminate many of the existing with its servicing ESRD network; (4)
assessment and performance requirements and establish critical medical recordkeeping; and (5)
improvement requirement and the central requirements. The central minimum operating responsibilities of
development of a comprehensive data requirements of the proposed rule are the facility, including data collection
set that will contain information on the grouped into three broad categories: (1) and reporting requirements
characteristics of ESRD facilities, its Patient safety; (2) patient care (which (governance).
patient population, as well as outcome includes quality assessment and We recognize that there are some who
measures of patient care. performance improvement); and (3) believe that regulations—particularly
The fundamental principles that administration. Subpart A contains those that directly affect the health and
guided us during this collaborative general provisions, for example, safety of patients—should be very
effort to develop new conditions were as statutory authority, definitions, and prescriptive in their detail to ensure that
follows: requirements for compliance with providers do not engage in practices that
• Ensure that patients’ rights and Federal, State and local laws and threaten patient health and safety.
physical safety are protected. regulations. Subparts B (patient safety) Therefore, we invite public comment on
• Stress continuous quality and C (patient care) of the proposed this fundamental shift in our regulatory
assessment and performance conditions for coverage would focus the approach, especially in terms of: (1)
improvement, incorporating, to the facility’s efforts on the actual care How we could improve on this
greatest extent possible, outcome- delivered to the patients, the approach; (2) what additional
oriented, data-driven measures. Thus, performance of the dialysis facility, and requirements could be removed or
the new conditions would invest a the impact of the treatment furnished by added to provide greater flexibility; and
major expectation for performance in a the dialysis facility on the health status (3) which existing and new
requirement that each facility of its patients. requirements are critical to patient care
participate in its own quality In Subpart B (patient safety), we are and safety.
assessment and performance proposing to retain and strengthen some
process-oriented patient safety E. Development of Outcome-Based
improvement program. This allows the Performance Quality Measures
facility flexibility to create its own self- provisions that we believe remain
tailored program of continuous quality highly predictive of ensuring desired Sections 1881(b)(5)(B) through (D) of
improvement. Facilities could be outcomes and preventing harmful the Act provide authority for us to
flexible and creative in their approach outcomes. Accordingly, the patient obtain the data we need from ESRD
to patient care and delivery of services safety requirements incorporate current suppliers. In accordance with these
as they use their own information to CDC infection control procedures, retain goals, we envision an information
assess and improve patient services, and update our incorporation by system that protects patients’ privacy in
outcomes, and satisfaction. reference of the AAMI standards and compliance with the new privacy
• Facilitate flexibility in how dialysis guidelines for water quality and dialyzer protections afforded by the
facilities meet our performance reuse practices, and incorporate by Department’s health information
requirements; reference applicable current Life Safety privacy regulations at 45 CFR Parts 160
• Eliminate unnecessary Code (LSC) provisions. and 164. These regulations were
administrative policies. Process- Subpart C (patient care) includes: (1) developed under the authority of the
oriented standards are only included Requirements that emphasize a dialysis Health Insurance Portability and
where we believe they are essential to facility’s fundamental responsibility to Accountability Act of 1996 (HIPAA).
protect patient health and safety; respect and promote the rights of each The data could be accessed by us as
• Focus on the continuous, patient (patient rights); (2) the critical well as dialysis patients, the public,
interdisciplinary, integrated care system nature of a comprehensive assessment dialysis facilities, State survey agencies,
that a dialysis patient experiences, in determining appropriate treatments ESRD networks, researchers, policy
centered around patient assessment, and achieving desired health outcomes makers, renal physicians, and other
care planning, service delivery, and (patient assessment); (3) the professionals providing care to dialysis
quality assessment and performance interdisciplinary team approach of patients (where permitted by the
improvement; and providing dialysis services to patients privacy regulations). This system would
• Stress patient satisfaction and and the process by which the provide information to meet the needs
ongoing patient involvement in the interdisciplinary team will achieve of the entire renal community,
development of the care plan and effective patient health outcomes particularly the patients, to make better
treatment. (patient plan of care); (4) the quality choices about care, and to help dialysis
• Finally, in order for the ESRD assessment and performance providers identify opportunities for
facility conditions to move from a improvement program which would continuous improvement in patient care
process and structure orientation toward charge each dialysis facility with the processes.
a more patient-centered, outcome- responsibility for carrying out a This proposal is in keeping with our
oriented approach, individual patient performance improvement program of strategic plan to help patients and the
and facility specific outcome measures its own design to affect continuing public become better informed about the
must be identified and evaluated or in improvement in quality outcomes and health care services they need and
the absence of existing measures, they patient satisfaction; and (5) the receive so they can make better health
care choices and participate more fully quality improvement activities. The data the guidelines was made available for
in their care. The availability of that form the basis for these facility- public review by all interested
information will permit patients to specific reports are used to report individuals or parties.
become more active and effective patient outcomes and to develop Four sets of DOQI clinical practice
participants in their own care and in additional reports. guidelines were published by the NKF
their facility’s quality improvement CMS has expanded the Facility in 1997, including recommended
process. Specific Reports to include a broader practices for management of anemia,
array of information, including facility- adequacy of hemodialysis, adequacy of
1. Dialysis Facility Compare specific reports for the use of State peritoneal dialysis, and vascular access.
One of the first steps to make survey agencies, state-specific reports, In 2000, the scope of DOQI expanded to
information more available to the public and region-specific reports. The facility- encompass the spectrum of chronic
is the CMS Dialysis Facility Compare specific reports have been improved by kidney disease prior to the need for
website at: http://www.Medicare.gov/ the expansion of facility practice pattern dialysis services. To reflect this
Dialysis/Home.asp. Dialysis Facility information, explanatory text with each expansion, DOQI became K/DOQI. A
Compare contains various dialysis report, table and graph modifications, total of 114 chronic kidney disease
facility characteristics and specific and the inclusion of additional risk- clinical practice guidelines were
quality measures including the adjusters in the calculations of the developed by the workgroups and
percentage of in-center hemodialysis standardized mortality ratio. reviewed by numerous professionals
patients with a urea reduction rate and patients. The NKF has published
(URR) (a measure of the adequacy of 4. The National Kidney Foundation
Bone Metabolism and Disease in
Kidney Disease Outcomes Quality
dialysis) equal to or greater than 65, the Chronic Kidney Disease clinical practice
Initiative (NKF–K/DOQI) Clinical
percentage of patients treated with guidelines and Hypertension and
Practice Guidelines
Epogen who have hematocrits of 33 Antihypertensive Agents in Chronic
percent or greater (reflecting adequately In March 1995, the National Kidney Kidney Disease as well as Managing
managed anemia), and patient data Foundation (NKF) initiated the National Dyslipidemias guidelines. The latest set
categories on every dialysis facility Kidney Foundation-Dialysis Outcomes of clinical practice guidelines being
approved to participate in the Medicare Quality Initiative (NKF–DOQI), the first developed under the K/DOQI umbrella
program. comprehensive effort in nephrology are the CPGs for Cardiovascular Disease
designed to provide evidence-based in Dialysis patients.
2. Dialysis Facility Data Reporting guidance to clinical care in nephrology.
Requirements Development of the NKF–DOQI clinical 5. CMS ESRD Clinical Performance
Sections 1881(b)(5)(B) through (D) of practice guidelines involved a 2-year Measures Project
the Act require ESRD suppliers to effort in which independent In 1999, we merged our ongoing ESRD
furnish all necessary information to interdisciplinary workgroups reviewed Core Indicators Project, a quality
CMS, the ESRD networks, and State the available body of scientific literature improvement project, originally started
survey agencies. Moreover, existing on hemodialysis and peritoneal dialysis in 1994, into a new ESRD Clinical
regulations at § 405.2133 require that adequacy, vascular access, and anemia. Performance Measures Project (ESRD
each ESRD facility furnish data and Each workgroup was composed of renal CPM Project). The ESRD CPM Project is
information in a manner and frequency experts from diverse clinical disciplines an ongoing effort between us, the ESRD
specified by the Secretary. This and renal patients. The workgroups networks, and dialysis facilities to
proposed regulation would continue to were tasked with developing and collect performance measures on a
require facilities to provide data and promulgating clinical practice representative sample of dialysis
other information, but in electronic guidelines for the treatments of patients patients in the areas of adequacy of
format, including clinical performance with ESRD. Four principles guided the dialysis, anemia management, nutrition
measures (CPM) data, necessary for the project’s decision-making: (1) Use of a (that is, serum albumin), and more
administration of the ESRD program. high level of scientific and recently, vascular access (DHHS/CMS/
methodological rigor in the guideline CBC, pp. 1–104). The ESRD CPM Project
3. Facility Specific Reports development process; (2) commitment was developed to implement section
In 1996, CMS first distributed facility- to an interdisciplinary approach; (3) 4558(b) of the Balanced Budget Act
specific reports to Networks and independence of the workgroups; and (BBA) of 1997 (Pub. L. 105–33). This
facilities. These reports were compiled (4) openness of the guideline provision required the Secretary to
by the University of Michigan, using development process. To that end, the develop and implement a method to
data from the CMS forms used for workgroups developed draft guidelines measure and report on the quality of
patient eligibility and patient death with supporting rationales that included renal dialysis services provided under
purposes; the CMS claims forms; the the evidentiary basis for the Medicare no later than January 1, 2000.
certification forms; and facility-specific recommendations. The goal of the CPM Project was to
data on infection control practices Draft guidelines were subject to an identify NKF DOQI guidelines that were
collected by the CDC. unprecedented three-stage review suitable for the agency’s quality
The initial reports presented process: (1) An advisory council, improvement initiatives and to meet the
comparative data on patient comprised of 25 experts, provided BBA requirement. The ultimate purpose
characteristics, patient outcomes, and comments on the initial draft of the of the project is to assist suppliers of
facility practice patterns. A common guidelines; (2) a variety of organizations ESRD services in improving the care
CMS database and common data (that is, ESRD networks, professional provided to ESRD patients.
formulations were used to create these and patient associations, dialysis In 1998, we contracted with PRO-
reports. Each year since 1996, these providers, government agencies, West (now named Qualis Health), a
reports have been distributed to ESRD product manufacturers, and managed Seattle-based private nonprofit
Networks and ESRD facilities. The care groups) were invited by NKF to healthcare quality improvement
reports have formed a basis for review and comment on a revised draft organization, to facilitate the process of
implementing and understanding of the guidelines; and (3) a final draft of developing dialysis clinical
performance measures (CPMs) based on a strong evidence basis were eliminated CHI standards will be incorporated
the NKF’s DOQI (now K/DOQI) from further consideration. Sixteen when we upgrade the ESRD information
guidelines. CPMs were developed based on 22 of 36 system.
The process included several candidate NKF DOQI clinical practice Following the upgrade to the ESRD
components. The first was to develop a guidelines. information system, ESRD facilities will
mechanism to assure appropriate Data collection instruments were be required to submit data using the
participation from the community in subsequently developed and submitted new information technology (IT) system.
order to facilitate the acceptability and to us for field testing. Three data They can accomplish submission of data
utility of the CPMs. The second was to collection tools were developed and that is consistent with the CHI standards
prioritize the NKF DOQI guidelines pilot tested. The first instrument was by either modifying their internal
based on the strength of the evidence intended to collect data for the systems or by using mapping tools that
supporting the guidelines, the feasibility hemodialysis adequacy, anemia are provided by the National Library of
of developing performance measures, management, and vascular access CPMs Medicine (NLM) at no cost. The CHI
and the significance of the areas from hemodialysis patient records. The standards are posted on the egov.gov
addressed to the quality of care second instrument was designed to Web site located at http://
delivered to dialysis patients. The third collect adequacy and anemia www.whitehouse.gov/omb/egov/gtob/
was to identify a limited set of CPMs management data for peritoneal dialysis health_informatics.htm.
that could be used to support quality patients. The third instrument focused
6. CPM Data Reporting
improvement activities as well as assist on information about facility policies,
us in assessing nationally the quality of procedures, and practices related to ESRD CPM Project data have been
care delivered to Medicare beneficiaries. selected hemodialysis adequacy CPMs. collected for 1999, 2000, 2001, and 2002
The fourth was to develop sampling and In the summer of 1999, after field- and published in annual reports. The
data specifications for the CPMs to testing, the CPMs were applied to a 2001 ESRD CPM report can be found on
facilitate measurement. Finally, we sample of 8,853 randomly selected adult the Internet at http://www.cms.gov/esrd/
requested the development of data hemodialysis patients and 1,650 l.asp. The data for each year include a
collection and analysis strategies to be randomly selected adult peritoneal random sample, stratified by ESRD
used to augment the existing national dialysis patients. network, of adult in-center hemodialysis
performance measurement system. In summary, the NKF DOQI process patients and a random peritoneal
The CPM Project was conducted in resulted in a broad set of guidelines dialysis patient sample of 5 percent of
collaboration with a broad range of amenable to prioritization based on adult peritoneal dialysis patients in the
stakeholders in the community. In order strength of evidence, clinical nation. The sample size of adult in-
to facilitate this involvement, importance and feasibility. The current center hemodialysis patients was
participation was solicited through NKF K/DOQI guidelines are widely selected to allow us to be 95 percent
contacts with professional and accepted among the renal community confident that Network-specific
voluntary associations, presentations at and increase the likelihood that future estimates for selected clinical measures
national meetings, and invitations to CPMs can be developed and supported are accurate within plus or minus 5
individuals identified through a variety by a broad cross-section of stakeholders, percent. The sample also included a 30
of sources. including clinical practitioners, percent ‘‘over sample’’ for in-center
Four expert groups were convened to industry representatives, professional hemodialysis patients and a 10 percent
address each of the topic areas covered associations, and others interested in ‘‘over sample’’ for peritoneal dialysis
by the NKF DOQI guidelines: (1) assessment and improvement of the care patients to compensate for anticipated
Hemodialysis adequacy; (2) peritoneal provided to dialysis patients. nonresponse rates. In 2002, the in-center
dialysis adequacy; (3) vascular access; We have been working closely with hemodialysis sample included 8,863
and (4) anemia management. The NKF the ESRD networks and information patients and the peritoneal dialysis
DOQI guidelines were ranked via a technology contractors to develop the sample included 1,451 patients. Also, a
survey of renal experts for their Vital Information System to Improve 5 percent national sample of
suitability as candidates for Outcomes in Nephrology (VISION) hemodialysis facilities was drawn,
development of CPMs. All 114 NKF database. VISION is a patient-specific, consisting over 200 hemodialysis
DOQI guidelines were included on a facility-based, outcome-oriented facilities.
survey tool developed by CMS that was information system that will enable Three data collection tools were used,
distributed to the rapid response group dialysis facilities to electronically an in-center hemodialysis form (Form
(RRG) and other expert consultants. collect and report both demographic CMS–820), a peritoneal dialysis form
Suitability of guidelines was based on and clinical data that can be profiled to (Form CMS–821), and a hemodialysis
clinical importance, feasibility of assist efforts to improve outcomes of facility-specific form.
measurement, and the respondent’s care. VISION will capture, among other We believe that the ESRD CPM Project
assessment of the strength of the things, data from the CMS ESRD CPM is an effective tool to facilitate ESRD
evidence supporting the guideline. Project. VISION will be designed so that quality improvement, and this project
We accepted 36 proposed guidelines Consolidated Health Informatics (CHI) has successfully tracked positive
for further evaluation and the 4 expert standards will be met. improvements in patient outcomes of
groups developed specific review The CHI establishes health messaging care in several areas. The 2001 Annual
criteria, algorithms, and CPMs selected and vocabulary standards that enable Report for the ESRD CPM Project
through the prioritization process data sharing across all Federal systems. contains additional Outcomes
described above. The CPM development Implementation of the CHI standards is Comparison Tools (for hemodialysis and
process was a modification of a prospective (that is, applicable to new peritoneal dialysis). Outcomes
methodology described by the Agency systems and systems undergoing major Comparison Tools are practical quality
for Healthcare Research and Quality upgrades). Current plans are to upgrade improvement instruments that can be
(AHRQ) (formerly the Agency for Health the ESRD Information System within used by ESRD facilities to benchmark
Care Policy and Research (AHCPR)). the next 2 to 3 years. Since the CHI their performance outcomes against
Candidate guidelines that did not have standards are prospectively applied, the rates at the ESRD network’s level
(hemodialysis only) and the nation. The circular defines a ‘‘performance conditions for coverage will remain in
Therefore, we are proposing in the standard’’ as a standard that states part 405, subpart U. Through a separate
Governance condition for coverage requirements in terms of required proposed rule regarding conditions of
(§ 494.180(h)), that all ESRD facilities results with criteria for verifying participation for transplant hospitals,
collect and provide us with ESRD CPM compliance but without stating the we are proposing to move the renal
Project data electronically. This methods for achieving required results. transplant center conditions to part 482.
proposal applies only to the current ‘‘Voluntary consensus standards’’ are The ESRD conditions for coverage
CPMs and is discussed in more detail defined as standards developed or (health and safety provisions for dialysis
later in this preamble. We will carefully adopted by voluntary consensus facilities) would be moved from existing
evaluate any revisions to the CPMs as standards bodies, both domestic and 42 CFR part 405, subpart U, to a new 42
well as any future CPMs, developed in international. ‘‘Voluntary consensus CFR part 494, where they would follow
accordance with the National standards bodies’’ are organizations that regulations establishing standards for
Technology Transfer and Advancement plan, develop, establish, or coordinate other Medicare providers, such as the
Act of 1995 process (described in the voluntary consensus standards using conditions of participation for hospitals
next section of this preamble) for agreed-upon procedures. One example (42 CFR part 482), long-term care
possible inclusion as electronic of a voluntary consensus standards body facilities (42 CFR part 483), and home
reporting requirements. The Secretary is the National Forum for Health Care health agencies (42 CFR part 484). The
will provide notice and an opportunity Quality Measurement and Reporting, termination of Medicare coverage and
for comment in the Federal Register also known as the National Quality alternative sanctions conditions at
before the CPMs are updated or new Forum (NQF), which is currently § 405.2180 through § 405.2184 will be
measures are adopted. engaged in various projects such as recodified to § 488.604 through
standardizing measures of hospital § 488.610. Since many of the existing
7. Updating Existing ESRD Patient-
quality and developing diabetes ESRD conditions would be revised,
Specific Performance Measures and
mellitus treatment performance consolidated with other conditions, or
Developing Future ESRD Facility
measures. deleted, we also propose to completely
Performance Standards The expected products of a voluntary renumber and reorganize the
We would like to propose ESRD consensus body would include the requirements. The format for the
performance standards that dialysis measures or indicators and standards, as dialysis facility conditions for coverage
facilities would be required to meet as well as explanatory text and other represents a dramatic change from the
well as propose a method to recognize supporting documentation, such as organization of the existing regulations,
updates in existing consensus-based guidelines for reporting the indicators. which contain nearly 20 conditions
patient-specific performance measures. A voluntary consensus body would addressing organizational structure,
We are proposing to adopt a framework make a draft product available for utilization rate requirements, and other
that will utilize existing Federal general public review during the process-intensive requirements. The
legislation and operational guidelines. development of the measures. When the proposed regulations are divided into
The National Technology Transfer and performance standards are complete, we four subparts: general provisions,
Advancement Act of 1995 ((NTTAA) would evaluate them and then patient safety, patient care, and
Pub. L. 104–113) and OMB Circular A– promulgate the standards following the administration.
119 specify circumstances in which requirements of the Administrative The proposed organization of Part 494
Federal agencies should use technical Procedures Act. is as follows:
standards developed by voluntary We are not advocating the NQF as the
consensus bodies. The phrase voluntary consensus body that is most Subpart A—General Provisions
‘‘technical standards’’ is defined in the appropriate to develop ESRD § 494.1 Basis and scope.
NTTAA at section 12(d)(4) as performance standards. We have only § 494.10 Definitions.
‘‘performance-based or design-specific provided an illustration of the manner § 494.20 Compliance with Federal, State,
technical specifications and related in which performance standards are and local laws and regulations.
management systems practices.’’ being developed. Other organizations, Subpart B—Patient Safety
The NTTAA has been implemented for example, the NKF–K/DOQI, also § 494.30 Condition: Infection control.
by, among other things, the provisions function in a manner consistent with § 494.40 Condition: Water quality.
of the Office of Management and Budget voluntary consensus bodies. Once ESRD § 494.50 Condition: Reuse of hemodialyzers
(OMB) Circular No. A–119 (63 FR 8546, facility performance measures are and other dialysis supplies.
February 19, 1998). OMB Circular No. developed by a voluntary consensus § 494.60 Condition: Physical environment.
A–119 was published to: (1) Revise and body, the Secretary would evaluate Subpart C—Patient Care
clarify policies on Federal use and those facility performance measures and
development of voluntary consensus § 494.70 Condition: Patient rights.
adopt those that meet our needs for the § 494.80 Condition: Patient assessment.
standards; (2) set policy for conformity effective administration of the ESRD § 494.90 Condition: Patient plan of care.
assessment activities; and (3) improve program after notice and comment § 494.100 Condition: Care at home.
the clarity and effectiveness of the rulemaking required by the § 494.110 Condition: Quality assessment
previously published (October 20, 1993) Administrative Procedures Act. and performance improvement.
circular. By implementing the policies We will also reference the NTTAA § 494.120 Condition: Special purpose renal
in this circular, we intend to reduce to later in this preamble under our dialysis facilities.
a minimum our reliance on government- discussion of the Governance condition § 494.130 Condition: Laboratory services.
specific standards. for coverage (see § 494.180(h)). Subpart D—Administration
Definitions of terms and phrases
F. Summary of the Contents of the § 494.140 Condition: Personnel
within the circular are designed for very qualifications.
broad application, but are meant to be Proposed Rule
§ 494.150 Condition: Responsibilities of the
applicable to any specific and We are proposing to revise both the medical director.
appropriate subject matter, including content and the organization of the § 494.160 Condition: Relationship with
health care performance measures. existing regulations. The ESRD Network ESRD network.
§ 494.170 Condition: Medical ‘‘home dialysis’’ should also include staff) and requires conformity with other
recordkeeping. these institutional settings. laws (for example, fire safety,
§ 494.180 Condition: Governance. We propose to include the following equipment maintenance).
The following provides a detailed definitions in § 494.10: We propose to retain the requirement
discussion of each new requirement and • Dialysis facility means an entity that dialysis facilities must be in
a discussion of the existing ESRD that provides (1) outpatient compliance with applicable Federal,
requirements that have been revised or maintenance dialysis services; or (2) State, and local laws and regulations
deleted in this proposed rule. home dialysis training and support pertaining to fire safety, equipment, and
services; or (3) both. A dialysis facility any other relevant health and safety
III. Provisions of Proposed Part 494 may be an independent or hospital- issues. We are also proposing that
Subpart A (General Provisions) based unit (as described in § 413.174(b) dialysis facilities must be in compliance
A. Basis and Scope (Proposed § 494.1) and (c) of this chapter), or a self-care with the appropriate Federal, State, and
dialysis unit, which furnishes only self- local laws and regulations regarding
[If you choose to comment on issues in dialysis services. drug and medical device usage. An
this section please include the caption • Discharge means the termination of example of meeting applicable Federal
‘‘Basis’’ at the beginning of your patient care services by a dialysis regulations is that the dialysis facility
comment.] facility.
Proposed § 494.1, identifies the must use FDA-approved/cleared
• Furnishes directly means the ESRD medical devices and adhere to the
statutory authority for the regulations. facility provides the service through its
Proposed § 494.1 also states that devices’ labelling instructions. We have
own staff and employees or through added these examples because drugs
provisions of part 494 serve as the basis individuals who are under contract with
for survey activities for determining and medical devices are major
the facility to furnish these services components of dialysis facilities and
whether a dialysis facility meets the personally for the facility. We note that
conditions for coverage under the compliance with existing laws and
furnishes directly does not apply to regulations in this area is important in
Medicare program. We note that the companies providing services under
organizational format of the proposed ensuring patient safety.
contract or arrangement. We may find a facility to be in
conditions permits the elimination of • Home dialysis means outpatient violation of these conditions for
almost all of the material in existing dialysis performed at home by an ESRD coverage if the facility is found out of
§ 405.2100, Scope of subpart, which patient (or caregiver) if the individual compliance with any Federal, State, and
consists largely of a description of the performing such dialysis has completed local law or regulation pertaining to
contents of the existing ESRD the course of training required in health and safety requirements.
conditions for coverage. § 494.100(a) of this part.
B. Definitions (Proposed § 494.10) • Interdisciplinary team (as required IV. Provisions of Proposed Part 494
in § 494.80 (Patient assessment)) means Subpart B (Patient Safety)
[If you choose to comment on issues in the group of persons responsible for
this section please include the caption A. Infection Control (Proposed § 494.30)
providing patient care to each dialysis
‘‘Definitions’’ at the beginning of your patient. [If you choose to comment on issues in
comment.] • Self-dialysis means dialysis this section please include the caption
Under proposed § 494.10, we set forth performed with little or no professional ‘‘Infection Control’’ at the beginning of
definitions for terms used in the ESRD assistance by an ESRD patient (or your comment.]
conditions. Existing § 405.2102 provides caregiver) if the individual performing Patients with ESRD have impaired
a list of 32 definitions. We are proposing such dialysis has completed an immunological systems and are more at
to eliminate the definitions of several appropriate course of training as risk of developing serious infections
terms for which we believe the meaning required in § 494.100(a) (Care at Home). than similarly situated non-ESRD
is self-evident, as well as terms that are • Transfer means a temporary or patients. During hemodialysis therapy,
not used in the revised conditions. We permanent move of a patient from one there is a potential for patients to be
do not believe it is appropriate to have dialysis facility to another that requires exposed to a variety of microbial
substantive requirements contained in the transmission of the patient’s medical pathogens (including blood-borne
those definitions. Thus, we would move record information to the facility pathogens) if proper procedures are not
definitions that contain qualification receiving the patient. meticulously followed. Likewise,
requirements to the appropriate peritoneal dialysis patients are at risk of
conditions in the proposed rule. We C. Compliance With Federal, State, and contamination leading to peritonitis if
have proposed to retain the definition of Local Laws and Regulations (Proposed proper procedures are not followed.
‘‘furnishes on the premises’’ and add it § 494.20) This proposed rule stipulates that the
to proposed § 494.180 (Governance). We [If you choose to comment on issues in dialysis facility must provide and
are proposing a modification of the this section please include the caption monitor conditions to ensure a sanitary
definition of ‘‘home dialysis’’ to ‘‘Compliance with Laws and environment that prevents the
recognize the assisting role that a family Regulations’’ at the beginning of your transmission of infectious agents.
member/caregiver may play. We have comment.] The existing standards relating to
previously received questions about Existing § 405.2135 requires that a infection control are contained in
whether the definition of ‘‘home’’ dialysis facility be in compliance with § 405.2140(b)(1) and (c). Section
includes institutional settings such as applicable Federal laws and that a 405.2140(b)(1) requires written
nursing facilities (NFs) and skilled dialysis facility be licensed or approved procedures for controlling hepatitis and
nursing facilities (SNFs). Please refer to as meeting applicable standards by the other infections. It further specifies that
section V.D. of this preamble in which agency of the State or locality the procedures include surveillance and
we discuss the unique needs of the NF/ responsible for approval. Section reporting of infections, housekeeping,
SNF dialysis patient and the overall 405.2135 further requires a facility to handling of waste and contaminants,
issue. We are soliciting comment on comply with all relevant laws (for and sterilization and disinfection.
whether the definition of ‘‘home’’ for example, laws relating to licensure of Section 405.2140(c) requires the facility
to employ appropriate techniques to Recommended Infection Control individual patients, they must be
prevent cross-contamination between Practices for Hemodialysis Units at a cleaned between patients.
the unit and adjacent hospital or public Glance • Clean areas should be clearly
areas. designated for the preparation, handling
We believe infection control is vital to Infection Control Precautions for All
Patients and storage of medications and unused
the health and safety of dialysis patients supplies and equipment. Clean areas
and others; and therefore, we propose to • Wear disposable gloves when caring should be clearly separated from
establish infection control as a separate for the patient or touching the patient’s contaminated areas where used supplies
condition for coverage (§ 494.30). The equipment at the dialysis station; and equipment are handled. Do not
proposed infection control requirement remove gloves and wash hands between handle and store medications or clean
states that each dialysis facility must each patient or station. supplies in the same or an adjacent area
provide and monitor a sanitary • Items taken into the dialysis station to that where used equipment or blood
environment that prevents and controls should either be disposed of, dedicated samples are handled.
the transmission of infectious agents, for use only on a single patient, or
within and between the unit and any • Use external venous and arterial
cleaned and disinfected before taken to pressure transducer filters/protectors for
adjacent hospital, or other public areas. a common clean area or used on another
The proposed requirement sets forth the each patient treatment to prevent blood
patient. contamination of the dialysis machines
basic guidelines or procedures that
—Nondisposable items that cannot be pressure monitors. Change filters/
facilities must follow to prevent and
cleaned and disinfected (e.g., adhesive protectors between each patient
control infections.
Proposed § 494.30(a)(1) requires that tape, cloth covered blood pressure cuffs) treatment, and do not reuse them.
the facility demonstrate that it follows should be dedicated for use only on a Internal transducer filters do not need to
standard infection control precautions, single patient. be changed routinely between patients.
including the ‘‘Recommended Infection —Unused medications (including • Clean and disinfect the dialysis
Control Practices for Hemodialysis multiple dose vials containing diluents) station (chairs, beds, tables, machines,
Units At a Glance’’ with the exception or supplies (syringes, alcohol swabs, etc.) between patients.
of screening for Hepatitis C as explained etc.) taken to the patient’s station should
be used only for that patient and should —Give special attention to cleaning
below. The ‘‘At a Glance’’ section is in control panels on the dialysis
the publication, ‘‘Recommendations for not be returned to a common clean area
or used on other patients. machines and other surfaces that are
Preventing Transmission of Infections frequently touched and potentially
Among Chronic Hemodialysis Patients’’ • When multiple dose medication
contaminated with patients’ blood.
developed by the Centers for Disease vials are used (including vials
Control and Prevention (CDC) (DHHS/ containing diluents), prepare individual —Discard all fluid and clean and
CDC, 20–21). We propose to incorporate patient doses in a clean (centralized) disinfect all surfaces and containers
these guidelines to prevent and control area away from dialysis stations and associated with the prime waste
cross contamination and the spread of deliver separately to each patient. Do (including buckets attached to the
infectious agents. These CDC infection not carry multiple dose medication vials machines).
control recommendations specific to the from station to station. • For dialyzers and blood tubing that
hemodialysis setting were developed in • Do not use common medication will be reprocessed, cap dialyzer ports
consultation with other Federal agencies carts to deliver medications to patients. and clamp tubing. Place all used
and specialists and are based on Do not carry medication vials, syringes, dialyzers and tubing in leak-proof
available knowledge regarding alcohol swabs or supplies in pockets. If containers for transport from station to
transmission of infectious agents. trays are used to deliver medications to reprocessing or disposal area.
SCHEDULE FOR ROUTINE TESTING FOR HEPATITIS B VIRUS (HBV) AND HEPATITIS C VIRUS (HCV) INFECTIONS
Patient status On admission Monthly Semi-annual Annual
All patients HBsAg*, Anti-HBc (total)* Anti-HBs*,

Anti-HCV, ALT†
HBV susceptible, including non-re- HBsAg

sponders to vaccine
Anti-HBs positive(>10 mIU/mL), anti- Anti-HBs

HBc negative
Anti-HBs and anti-HBc positive No additional HBV testing needed
Anti-HCV negative ALT Anti-HCV
Hepatitis B Vaccination an additional three doses, and retest Management of HBsAg-Positive Patients
for anti-HBs.
• Vaccinate all susceptible patients • Follow infection control practices
against hepatitis B. —If anti-HBs is >10 mIU/mL, consider for hemodialysis units for all patients.
immune, and retest annually.
• Test for anti-HBs 1–2 months after • Dialyze HBsAg-positive patients in
last dose. —Give booster dose of vaccine if anti- a separate room using separate
HBs declines to <10 mIU/mL and machines, equipment, instruments, and
—If anti-HBs is <10 mIU/mL, consider
continue to retest annually. supplies.
patient susceptible, revaccinate with
• Staff members caring for HBsAg- Existing § 405.2140(b)(1) requires that information on procedures a facility
positive patients should not care for written policies and procedures must be may adopt to meet this requirement.
HBV susceptible patients at the same in effect for preventing and controlling We considered proposing to include
time (e.g., during the same shift or hepatitis and other infections. There is the American Institute of Architects
during patient change-over). no current requirement in the (AIA) Guidelines for Design and
We are proposing an exception to the conditions for coverage addressing Construction of Hospitals and Health
CDC recommendation for monthly and patient isolation. However, many Care Facilities, which outline building
semiannual screening for all facilities have adopted the 1977 CDC requirements pertinent to dialysis
hemodialysis patients for hepatitis C. guidelines that recommend use of a facilities. The AIA standards provide
Patients with clinical indicators or risk separate dialysis area, preferably a guidance to facilities regarding unit
factors for hepatitis C should receive separate isolation room, for dialyzing design and parts of the guidance relate
diagnostic testing as deemed necessary hepatitis B surface antigen positive to infection control. While we believe it
by the attending physician. Medicare patients. Newly opened hemodialysis is desirable for new units to follow AIA
covers diagnostic testing for hepatitis C standards, and many States have
units would be required to have
on a case-by-case basis, but does not adopted these as minimum standards,
isolation rooms for hepatitis B positive
cover blanket hepatitis C screening at we recognize it may be overly
patients as described in the ‘‘At a
this time. According to the CDC, burdensome to require existing dialysis
Glance’’ section. For existing units in units to adhere to these standards.
transmission of hepatitis C can be which a separate room is not possible,
prevented by strict adherence to We also considered including in the
there would be required to be a separate proposed rule the Healthcare Infection
infection control precautions area removed from the mainstream of
recommended for all hemodialysis Control Practices Advisory Committee’s
activity that also allows for dedicated (HICPAC) guidelines entitled ‘‘Hand
patients. staff and dedicated dialysis machines. Hygiene in Healthcare Settings’’ and
The ‘‘At a Glance’’ page highlights the When the facility determines that a ‘‘Guideline for Preventing Intravascular
crucial CDC recommendations that patient is infectious (from admission or Device-Related Infections.’’ We are
serve as the minimum acceptable at least annual testing) the guidelines inviting comments on whether we
infection control practices. This state that the facility would be required should require new dialysis facilities to
document reproduced above is currently to isolate the infected patient from adhere to AIA design standards or
available on the CDC Web site at http: susceptible patients to prevent the HICPAC guidelines.
//www.cdc.gov/mmwr/preview/ transmission of the disease. We propose We propose requirements for
mmwrhtml/rr5005a1.htm. to require at § 494.30(a)(2) that a facility oversight of facility infection control in
There is substantial evidence that the implement and maintain patient § 494.30(b). The facility must implement
CDC guidelines work in preventing the isolation procedures that prevent and and monitor biohazard and infection
transmission of bloodborne infections. control the spread of infectious agents control policies and activities within the
Recommendations for the control of and communicable diseases. dialysis unit. Any infection control
hepatitis B in hemodialysis centers were policies adopted by the facility are only
first published in 1977 and within 3 We also propose at § 494.30(a)(3) that
effective when put into action. We
years there was a sharp reduction in facilities implement appropriate
propose that facilities must designate a
incidence of hepatitis B infection among procedures for the handling, storage,
registered nurse as the infection control
both patients and staff members in and disposal of waste, and for
or safety officer who maintains current
hemodialysis centers (Alter, pp. 860– disinfection. Appropriate waste storage
infection control information, and
865). and disposal procedures are important reports to the facility’s chief executive
The entire CDC RR05 report contains not only for the control of infections officer or administrator and quality
recommendations for infection control within the units, but also for the welfare improvement committee. The infection
precautions in greater detail than the of the unit staff and the community. control nurse must maintain current
‘‘At a Glance’’ highlights. We Since local policies vary, we do not infection control information including
considered proposing that the entire believe it is appropriate to specify the the most current CDC guidelines for the
CDC RR05 document be incorporated by minimum requirements for waste proper techniques in the use of vials
reference. However, we want to be less storage and disposal. Rather, facilities and ampules containing medication. For
prescriptive and burdensome in our should continue to operate in example, facilities should not pool vials
requirements while protecting patient accordance with applicable local laws of any medications. An outbreak of
safety. Dialysis facilities are encouraged and accepted public health procedures. serratia liquefacies from contamination
to utilize the more comprehensive We also propose to require that facilities of erythropoietin at a hemodialysis
document when developing their implement protocols for cleaning and center serves as a reminder of the
infection control programs. For disinfection because we believe that importance of the proper handling of
example, the CDC infection control adequate disinfection of surfaces, medications in protecting the dialysis
precautions for all patients identify medical devices, and equipment is an patient. (Grohskopf, pp. 1491–1497.)
procedures for cleaning up a blood spill; important part of a facility’s efforts to The infection control or safety officer
and detail information on glove use, control and prevent cross- is also responsible for making
protective gear, and handwashing. The contamination. We propose to add a recommendations regarding infection
CDC has issued additional guidance requirement for the implementation and control training and improvements. The
regarding hand hygiene and maintenance of procedures regarding designation of an infection control
environmental infection control in the cleaning of surfaces and devices officer provides a structure for infection
October 25, 2002 and June 6, 2003 potentially contaminated with blood to control, encourages the maintenance of
issues of the Morbidity and Mortality prevent patients from coming into up-to-date information, and increases
Weekly Report that dialysis facilities contact with a blood-borne pathogen. accountability for infection control.
may want to reference in their infection The CDC RR05 recommendations and We propose to maintain the essence of
control policies (DHHS/CDC, pp.1–45 dialysis equipment manufacturers’ the existing requirement for surveillance
and DHHS/CDC, pp. 1–44, respectively). instructions provide valuable and reporting of the incidence of
infection (§ 405.2140(b)(1)). The facility for communicable diseases are listed at ‘‘Hemodialysis Systems,’’ ANSI/AAMI
must analyze and document the § 494.30(d). The facility must maintain RD5: 1992, sections 3.2.1, 3.2.2, and
incidence of infections to identify a current list of the communicable Appendix B, sections B1–B5 (American
trends and establish baseline diseases that must be reported according National Standards Institute 1992). Each
information on infection incidence as to Federal, State, and local AAMI standard or recommended
proposed in § 494.30(c). By conducting requirements, and have a procedure for practice reflects the collective expertise
a trend analysis of infections, the reporting these communicable diseases, of a committee of health care
facility will be able to identify which allows the facility to accurately professionals and industrial
opportunities for improvement to report incidences of communicable representatives, whose work has been
prevent or eliminate the spread of diseases. These requirements are in reviewed nationally. AAMI standards
infection or communicable disease concert with the present standard and guidelines undergo a regular 5-year
between patients. By tracking the operating practices in dialysis facilities. review process that allows updates and
number and types of infections, the revisions. These consensus
B. Water Quality (Proposed § 494.40)
facility can identify areas that require recommendations are intended to help
improvement, indicate areas that have [If you choose to comment on issues in ensure patient safety.
improved, define measures to improve this section please include the caption The AAMI guidelines referenced in
outcomes, review implementation of ‘‘Water Quality’’ at the beginning of the existing conditions for coverage
improvement measures, and determine your comment.] have been replaced by more recent
the success of the improvement Water quality is of vital importance to AAMI guidelines, and therefore, we are
measures implemented. a dialysis facility and to the patient. proposing to incorporate new AAMI
In August 1999, the CDC initiated the Because we believe water quality is an references. The ANSI/AAMI RD5: 1992
CDC Dialysis Surveillance Network essential health and safety issue for document has been replaced by
(DSN), a voluntary national surveillance ESRD patients, we are proposing a ‘‘Concentrates for Hemodialysis’’ ANSI/
system monitoring bloodstream and condition for coverage for water quality AAMI RD61: 2000, ‘‘Water Treatment
vascular infections by individual in this proposed rule. Equipment for Hemodialysis
hemodialysis centers. The purposes of The hemodialysis patient’s blood has Applications’’ ANSI/AAMI RD62: 2001,
the DSN are to provide a method for the potential to be exposed to toxic and ‘‘Dialysate for Hemodialysis’’ ANSI/
individual hemodialysis centers to contaminants present in water. Some AAMI RD 52:2004. These publications
record and track rates of vascular access chemical contaminants are not normally update the information on monitoring of
infections, other bacterial infections, harmful when present in small amounts water quality currently incorporated by
and intravenous antimicrobial starts, in usual physiological fluids. However, reference in § 405.2140(a)(5) and
and to provide rates for comparisons since hemodialysis patients are exposed provide additional recommended
among various dialysis centers. The to the large volume of water that is used practices.
infection control or safety officer should to make dialysate, chemical We are proposing to incorporate by
look toward the CDC surveillance contaminants can be dangerous to them. reference the following revised AAMI
system as a resource. Information on the If water supplies are biologically or water quality standards, published in
DSN may be found on the following chemically contaminated, the patient ‘‘Water Treatment Equipment for
Web site: http://www.cdc.gov/ncidod/ may experience infection or other Hemodialysis Applications,’’ 4.2.1 and
hip/Dialysis/dsn.htm. adverse consequences. Limits on 5.2.1, Water Bacteriology; 4.2.2 and
The existing standard governing bacterial growth in water and dialysate 5.2.2, Maximum Level of Chemical
infection control (§ 405.2140(b)(1)) are necessary to prevent high bacterial Contaminants; and 4.3, Water Treatment
contains a requirement governing reuse counts associated with pyrogenic Equipment requirements (American
of dialyzers which states that when reactions (fevers, chills, nausea). National Standards Institute, 2001). The
dialysis supplies are reused, records are The patient’s exposure to updated water purity standards, section
maintained that can be used to contaminated water can be through 4.2.1, now include bacteria and
determine whether established water mixed with dialysate, water endotoxin action levels that identify the
procedures covering the rinsing, mixed with reprocessing germicides, or concentration at which steps (such as
cleaning, disinfection, preparation, and water used to flush out dialyzers. system disinfection and retesting)
storage of reused items conform to the Contamination of the water system with should be taken to reduce the levels to
requirements for reuse. This standard is organic and inorganic chemicals, an acceptable range. Facilities must take
redundant with the reuse requirements bacteria, and endotoxins can result in corrective action when these action
included in the AAMI guidelines that adverse patient reactions, such as levels are met or exceeded.
are incorporated by reference in both hemolysis, bacteremia, pyrogenic The AAMI list of contaminants for
the existing and proposed regulations. reactions, or death. Exposure to some which water must be tested has been
Therefore, we are proposing to delete contaminants such as aluminum can expanded to include antimony,
the requirement in § 405.2140(b). cause chronic health problems, while beryllium, and thallium. These
Existing § 405.2140(c) requires that exposure to other contaminants such as chemicals were added based on changes
written patient care policies specify the fluoride can be fatal. Therefore, a in the United States Environmental
functions of facility personnel and self- dialysis facility must monitor the Protection Agency Safe Drinking Water
dialysis patients with respect to quality of the water used in treatments, Act 1996 (Pub. L. 104–182). AAMI’s
contamination prevention. We are as well as monitor the equipment used rationale for testing water for these
proposing to delete the ‘‘written policy’’ in water treatment. contaminants may be found in the
requirement because it is process- In the September 18, 1995 Federal appendix of the ANSI/AAMI RD62:
oriented and a paperwork burden. Register (60 FR 48039), we published a 2001 document at A.4.2.2 (American
As noted above, the existing final rule that incorporated by reference National Standards Institute, 2001).
conditions for coverage require policies the 1992 AAMI standard for water We have also included the updated
for surveillance and reporting of quality and the AAMI recommended AAMI requirements for water treatment
infections at § 405.2140(b)(1). In this guidelines for monitoring purity of equipment. This inclusion provides
proposed rule, reporting requirements water as published in the clarity by defining the minimum
standards for water treatment ++ Reverse osmosis rejection rates, proposed § 494.40(c)(2)(i) would require
equipment needed to protect patient which are monitored daily using subsequent testing from the backup
safety. Proper hemodialysis is continuous-reading monitors that component (or second carbon tank) if
dependent on the quality of the measure product water conductivity, the test shows greater than 0.50 parts
dialysate. A water system consisting of fall below 90 percent. per million (ppm) for free chlorine or
the proper components and maintained Ultrapure dialysate has received 0.10 ppm for chloramine. Due to the
in accordance with the manufacturers’ attention in the clinical literature and dangers of chlorine/chloramine
instructions, can be expected to produce the working draft AAMI standards exposure, each water purification
dialysate that meets the AAMI standards ‘‘Dialysate for Hemodialysis’’ RD52 system must provide for the adequate
and produces acceptable patient contains guidelines pertaining to removal of chlorine/chloramine and this
outcomes. The minimum safety ultrapure dialysate. We are not is standard operating practice in
requirements are specified in the AAMI proposing a requirement for ultrapure hemodialysis facilities. In conformity
standards referenced in proposed dialysate at this time but we do invite with the referenced AAMI guidelines at
§ 494.40(a)(1)(iii) for each component of comment on this topic. We also 4.3.9, carbon tanks used for the removal
the water treatment system (that is, welcome comment on the requirements of chlorine/chloramine must contain
deionization, reverse osmosis, monitors, for the frequency of water purity testing. granulated activated carbon and provide
sediment filters, carbon absorption In addition, we are proposing further adequate empty bed contact time to be
media, automatically regenerated water evidence-based requirements consistent effective. A backup component or
softeners, storage tanks, piping systems; with AAMI guidelines within the second carbon tank must be in place for
and when used, ultrafilters, ultraviolet proposed water quality condition. The failure of the first line component for
irradiators, hot water disinfection existing conditions for coverage do not chlorine/chloramine removal (or first
systems, ozone disinfection systems, address requirements for the water carbon tank), in order to protect patients
and tempering valves). A water treatment equipment, although the during a hemodialysis session.
treatment system consisting of the interpretive guidelines for Dialysis facilities would be required
proper equipment components as § 405.2140(a)(5)(ii) do advise that water to follow the applicable FDA
identified by AAMI (and the Food and treatment systems must include a recommendations in ‘‘Guidance for the
Drug Administration (FDA)) is standard carbon tank and either a reverse osmosis Content of Premarket Notifications for
practice in dialysis facilities. or deionization system (DHHS/CMS, Water Purification Components and
We are proposing state of the art water 1995). We are proposing that the water Systems for Hemodialysis’’ that 2
purity monitoring guidelines outlined in treatment system must include a reverse carbon tanks be installed in series with
ANSI/AAMI RD52: 2004 ‘‘Dialysate for osmosis or deionization component that empty bed contact time of 10 minutes
Hemodialyzers’’ section 7.2.1 document. conforms to the referenced water (DHHS/FDA, 1997). The second carbon
Proposed § 494.40(a)(2) incorporates by treatment equipment for hemodialysis tank provides the backup safety
reference the section that specifies the applications AAMI guidelines 4.3.5 and measure. Some dialysis facilities have
frequency of water purity testing to 4.3.6. This is in keeping with current three or four carbon tanks that provide
insure meeting the AAMI limits standards of practice, which are widely even more assurance there will not be
specified in § 494.40(a)(1)(i) and (ii) as adhered to by dialysis facilities. The chloramine breakthrough. We invite
reverse osmosis process serves to comment as to whether our proposed
follows:
• Bacteria and bacterial endotoxin remove dissolved salts, bacteria, viruses, conditions for coverage that include
levels of water must be measured— pyrogens, and organic molecules. expanded water equipment
++ In established systems at least Deionization serves to remove ions. A requirements are still too minimal. In
monthly; reverse osmosis system along with addition, we are requesting comments
++ In newly-installed systems at least pretreatment is used in the vast majority on whether the current AAMI guidance
weekly until an established pattern of of all dialysis centers and this regarding carbon tanks is adequate to
compliance can be demonstrated. requirement should not present an address all potential health and safety
• At least monthly in samples drawn additional burden to hemodialysis problems associated with chlorine,
from— centers. chloramines, and unannounced
++ The first and last outlets of the A consequence of patient exposure to variations in source water. Specifically,
water distribution loop; high levels of chloramine via dialysis is we seek comments regarding where
++ Where water enters the dialyzer hemolytic anemia, which may be life- there is sufficient evidence to require
reprocessing equipment; threatening. The 1992 AAMI guidelines Medicare-participating dialysis facilities
++ Outlet of the water storage tanks, specified at least once daily testing of to maintain at least two carbon tanks
if used; purified water for chlorine/chloramine (that is, primary and backup) as part of
++ Concentrate or from the levels. It is now widely recognized that their water treatment system, regardless
bicarbonate concentrate mixing tank. testing before each shift of hemodialysis of the current composition of its source
• Bacteria levels must be measured at sessions, which is the current standard water.
least monthly from a sample of two or in many dialysis units, provides greater We are proposing in § 494.40(e) to
more dialysis machines, this sampling patient safety. Therefore, we are require active surveillance of
must ensure that all machines are tested proposing at § 494.40(c)(2) to require hemodialysis patient reactions during
at least once a year. chlorine/chloramine testing of water and following dialysis, particularly
• Chemical analysis of water purity samples that must be taken from the exit when there are adverse reactions that
must be done at least once a year and port of the initial chlorine/chloramine might be associated with a problem with
when— removal component (or carbon tank) the water purification system. The
++ The system is installed; prior to each patient shift or every 4 facility must take steps to protect
++ Membranes are replaced if using a hours, whichever is shorter, during patient safety and obtain the appropriate
reverse osmosis system; operation of the water system, unless blood and dialysate cultures. Evaluation
++ Seasonal variations in source the facility ensures on a daily basis that of the water purification system must be
water suggest worsening water quality; the source water is chlorine/chloramine undertaken as well as any necessary
and free by way of testing. In addition, corrective action (§ 494.40(d)).
If chlorine/chloramine levels in outcomes from reuse, reprocessing and Only hemodialyzers and bloodlines
treated water from the last backup reuse of dialyzers are safe when proper labeled for multiple use may be reused.
component (or carbon tank) are above techniques are utilized. In addition, manufacturers of reusable
the AAMI standards as required in The existing regulation at § 405.2150 hemodialyzers are required to provide
proposed § 494.40(a)(1)(ii), dialysis requires ESRD facilities reusing adequate instructions for safe and
treatments must be immediately hemodialyzers to meet the guidelines effective reuse in accordance with 21
stopped to protect patients from and standards adopted by AAMI and CFR 801.5. If the facility chooses to use
exposure to chlorine/chloramine as issued in July 1993, as ‘‘Reuse of an alternate method for reprocessing
proposed in § 494.40(c)(2)(ii). The Hemodialyzers’’ (American National hemodialyzers there must be sufficient
medical director, who is ultimately Standards Institute, 1993). We are scientific evidence that the method is
responsible for water quality, must be proposing to retain this requirement in safe and effective. This flexibility is
notified immediately and corrective the proposed rule but to incorporate by provided to allow for the use of newer
action taken. A corrective action plan is reference the newly revised version and and improved technologies that are
also required (see § 494.40(d)) whenever associated amendment (ANSI/AAMI proven safe in scientific studies which
any of the water purity action levels or RD47: 2002 and ANSI/AAMI RD47: may become available in the future. The
standards, including but not limited to, 2002/A1: 2003) which replaces the 1993 FDA approved label recommendations
chemical, microbial, and endotoxin, are version. This document received final for the proper use of the device must be
detected. AAMI approval on November 7, 2002. adhered to by dialysis facilities.
We propose to add a requirement, Some in the renal community believe Existing § 405.2150(a)(2) states that to
consistent with in the AAMI document that we should not incorporate the CDC prevent any risk of dialyzer membrane
RD52:2004, that specifies that once guideline that prohibits reuse for leaks due to the combined action of
mixed, bicarbonate concentrate must be hepatitis B patients. They believe there different chemical germicides, dialyzers
used within the time specified by the is no documentation that reuse are exposed to only one chemical
manufacturer of the concentrate and contributes to the spread of hepatitis or germicide during the reprocessing
may not be mixed with fresh that it negatively affects the patient with procedure. We have received informal
concentrate. The holding of the hepatitis. In addition, they indicated suggestions that we alter the current
bicarbonate concentrate presents the that this prohibition is costly to language because many facilities use
risk of bacterial growth and should be facilities because a new dialyzer must bleach as part of the reuse process to
avoided. be used for each session. flush and clean blood deposits before
We considered addressing water Hepatitis B is a highly contagious and the actual germicide soaking process is
quality for home dialysis patients in this potentially damaging illness, especially initiated. However, for purposes of
condition, but we decided instead to for a dialysis patient. Thus, the CDC has reuse, we consider bleach to be a
include a requirement that the facility for many years recommended extreme cleansing agent, not a germicide. The
monitor water used by its home dialysis caution and isolation for those patients requirement to discard dialyzers treated
patients to ensure that the water meets who are Hepatitis B positive. Many with a different germicide does not
the AAMI standards under the proposed physicians, nurses and other apply to bleaching. Nonetheless, since
‘‘care at home’’ condition for coverage professionals involved in the dialysis the language appears to be confusing to
(§ 494.100). Addressing all home field have similarly supported the some, we are proposing to clarify the
dialysis issues under a single condition position of extreme caution in treating provision in proposed § 494.50(b)(3) by
simplifies the organization of the the hepatitis B positive patient. The inserting the phrase ‘‘other than
regulations and eliminates the need for 2001 CDC guidelines advise against the bleach.’’
readers to refer to separate sections for reprocessing of dialyzers used for Some in the renal community and on
the requirements for home dialysis patients who have Hepatitis B because the AAMI RD47 workgroup stated that
services. of the risk to facility staff. The hepatitis discarding dialyzers exposed to a
virus is relatively stable in the second germicide was expensive and
C. Reuse of Hemodialyzers and environment and has been shown to unnecessary if air pressure leak test
Bloodlines (Proposed § 494.50) remain viable for several days on results indicated the dialyzer was still
Section 1881(f)(7) of the Act requires surfaces (via blood spills). While there effective. However, we are proposing to
the Secretary to establish protocols for may be no appreciable evidence to retain the requirement in existing
reuse of hemodialyzers for those demonstrate that reuse would increase § 405.2150 that if a dialyzer is exposed
facilities that voluntarily elect to reuse the spread of hepatitis B, there is not to a second germicide it must be
the filters. The Act further states that conclusive evidence that reuse in this discarded because we are concerned
dialysis facilities that fail to follow the population is safe. At this time we that exposure to different germicides
reuse protocol will be subject to denial propose to maintain the CDC guidelines may cause membrane leaks. While we
of participation in the Medicare prohibiting reuse for hepatitis B patients recognize that it may be considered
program and denial of payment for to minimize the incidence of this mode wasteful by some to discard dialyzers
dialysis treatment not furnished in of transmission. with test values that indicate they are
compliance with the reuse protocol. We are also proposing at still effective, we believe this is a
In hemodialysis the patient’s blood is § 494.50(b)(2) that the hemodialyzer necessary safety measure. We do not
cleansed of impurities when it passes manufacturer recommendations be have sufficient evidence that clearly
through the filter (hemodialyzer) of a followed, or if an alternate method for supports the safety of using multiple
hemodialysis machine. There are reprocessing hemodialyzers is used, that germicides on hemodialyzers. We
various techniques that allow some of the facility have documented evidence welcome comment on the issue of
these filters to be reused under certain that the method is safe and effective. multiple germicide use in reused
conditions. Reuse involves cleaning, According to FDA guidance, hemodialyzers.
disinfecting, and preparing such hemodialyzer labeling should reflect the Existing § 405.2150(a)(3) requires that
hemodialysis devices for subsequent use clinical use of a hemodialyzer, and facilities take appropriate blood cultures
for the same patient. Although the whether it is intended for single or at the time a patient has a febrile
potential exists for adverse patient multiple usage (DHHS/FDA, 1995). response and discontinue reuse of
hemodialyzers in the case of pyrogenic been accepted by the FDA; and that the patients or personnel and that there is
reactions, bacteremia, or unexplained facility must follow the FDA-accepted a planned program of preventive
reactions possibly associated with manufacturer’s protocol for reuse of the maintenance of equipment used in
ineffective reprocessing, until the entire bloodline. With these requirements, the dialysis and related procedures in the
reprocessing system is evaluated. We facility must follow any specific facility. We propose at § 494.60(b) to
have been advised that a single febrile instructions listed by the FDA, as well maintain the essence of this requirement
response in one patient can be the as any guidelines by the manufacturer but to clarify that all equipment is
consequence of many different that may not be discussed in the FDA maintained in accordance with the
etiologies not related to reuse, including regulations. We are proposing to delete manufacturer’s recommendations. Based
an infected access, a current infection, the second existing requirement that on their experience with the equipment,
or contamination of the water facilities not reuse bloodlines labeled we believe manufacturers have the most
purification system. Members of the for ‘‘single use only’’ because it is knowledge about routine maintenance
renal community suggested that a febrile redundant with the existing third and and recommended repair.
reaction in a single patient is rarely fourth requirements. Since the FDA Existing § 405.2140(b) requires each
attributed to dialyzer reuse. Facilities do would not recommend reuse on facility to maintain a favorable
not believe it is necessary to terminate bloodlines labeled ‘‘single use only,’’ environment for patients; and the
reuse or order blood cultures when a there is no need to maintain the facility must be maintained and
febrile reaction occurs in only a single requirement. equipped to provide a functional,
patient. It was suggested that a facility sanitary, and comfortable environment
D. Physical Environment (Proposed with an adequate amount of well-lighted
need only respond through aggressive § 494.60)
evaluation of its water purification space for the services provided. The
system, dialysis concentrates, and reuse [If you choose to comment on issues in existing language in this standard
system when the surveillance of febrile this section please include the caption combines several different concepts,
events reveals a cluster of febrile ‘‘Physical Environment’’ at the including sanitary environment and
patients. Based on this evaluation, the beginning of your comment.] infection control, and we propose to
The existing physical environment address each subject in separate sections
facility can make an appropriate clinical
condition (§ 405.2140) stipulates that of the regulation. As a result, we are
decision concerning termination of
the physical environment in which proposing at § 494.60(c) to include only
reuse. As a result, we are proposing in
dialysis services are furnished afford a those standards regarding the safety and
§ 494.50(c) to revise the regulations to
functional, sanitary, safe, and comfort of each patient.
state that a facility need only obtain
comfortable setting for patients, staff, Since the proposed conditions are
blood and dialysate cultures and and the public. The existing regulation outcome-oriented, we believe that we do
evaluate its reprocessing and water consists of four separate standards not need to specify all the process
purification systems in response to an concerning building and equipment, requirements that a facility must meet to
adverse reaction when clinically favorable environment for patients, provide a dialysis environment in
indicated. If the evaluation indicates contamination prevention, and which the patient can receive quality
that the facility should discontinue emergency preparedness. We propose to care. Each facility can develop its own
reuse, we expect facilities to have refine the physical environment section strategies and techniques as long as the
established contingency plans, suspend to include only those elements that space for treating each patient is
the reuse of hemodialyzers until the relate directly to the physical sufficient to provide needed care and
problem has been corrected, and report surroundings of the dialysis facility and services, prevent cross-contamination,
the adverse outcomes to the FDA and to relocate the remaining elements to and accommodate medically needed
other agencies as required by Federal, other sections in the proposed rule that emergency equipment and staff. Existing
State or local laws and regulations. relate more closely to those subject § 405.2140(b) also requires the facility to
Existing § 405.2150(c) lists 4 areas. provide a well-lit space. We propose to
requirements applicable to a facility that The existing building and equipment delete this requirement because it is too
reuses bloodlines. Facilities must: (1) requirements in § 405.2140(a), include subjective to be meaningful, and we
Limit the reuse of bloodlines to the fire safety procedures, equipment believe this detail is better left to the
same patient; (2) not reuse bloodlines maintenance, facility maintenance, and judgment of the facility staff.
labeled for ‘‘single use only’’; (3) reuse water treatment. Based on the We expect the dialysis facility to
only bloodlines for which the experience and suggestions of our provide patients with a comfortable
manufacturer’s protocol for reuse has surveyors, we propose to establish environment. Existing § 405.2140(b)(4)
been accepted by the FDA in accordance separate standards for the building itself requires that heating and ventilation
with the premarket notification (see in proposed § 494.60(a) and equipment systems be capable of maintaining
section 510(k) of the Food, Drug, and in proposed § 494.60(b). We propose to adequate and comfortable temperatures.
Cosmetic Act and 21 CFR 876.5860 of maintain the existing requirement We recognize that not all patients are
the regulations); and (4) follow the FDA- (described in § 405.2140(a)) that the comfortable at the same temperature;
accepted manufacturer’s protocol for building in which dialysis services are and therefore, proposed § 494.60(c)(2)
reuse of that bloodline. We propose to furnished be constructed and specifies that the facility maintain a
maintain the first requirement to limit maintained to ensure the safety of temperature that is comfortable for the
the reuse of bloodlines to the same patients, the staff, and the public. The majority of patients. The dialysis facility
patient because the risk of transmitting dialysis facility should be free from must make reasonable accommodations
blood-borne pathogens is so high, and hazards that may bring harm to the for patients who are not comfortable at
reusing for the same patient limits the patients, the staff, and the public. the temperature setting determined by
risk of cross-contamination. We also The existing language of the majority of patients. The facility has
propose to maintain the third and fourth § 405.2140(a)(2) stipulates that all the option of allowing patients to bring
requirements, that is, a facility may electrical and other equipment used in a blanket to dialysis or providing freshly
reuse only bloodlines for which the the facility be maintained free of defects laundered blankets to the patients.
manufacturer’s protocol for reuse has that could present a potential hazard to Infection control procedures must be
adhered to in either case. Often patients information available before an equipment. We propose to maintain this
need a warm environment because of emergency happens rather then requirement, but we want to eliminate
lowered body temperature during the scrambling to update this kind of the confusion regarding the meaning of
dialysis process, and therefore, facilities information during an emergency. As a ‘‘fully equipped.’’ We propose to define
should look to patients rather than staff resource in their movement toward an the minimum emergency equipment
to ascertain comfortable building emergency management approach, that must be on the premises and
temperatures. dialysis facilities may want to use the immediately available as ‘‘oxygen,
In the emergency preparedness ESRD facility emergency preparedness airways, suction, artificial resuscitator
standard (proposed § 494.60(d)), we guidelines available from the ESRD ventilation bag, defibrillator, and
have proposed requirements that we Networks. emergency drugs.’’ We propose to
believe are fundamental for a dialysis We propose to maintain the existing specifically require defibrillators.
facility to prepare effectively for requirement that a facility train each Automated external defibrillators
emergency situations. These staff member on the actions required for (AEDs), in particular, have been shown
requirements include: (1) Procedures for different medical and nonmedical
to save lives in a variety of settings,
medical and non-medical emergencies; emergencies. The existing conditions for
most notably aboard airlines and in
(2) staff and patient training; (3) facility coverage require that emergency
airports. One Seattle study (Arch Intern
emergency equipment; and (4) periodic preparedness procedures be reviewed
evaluation of emergency plans. Existing and tested at least annually and revised Med. 2001;161:1509–1512 available at
§ 405.2140(d) requires the facility to as necessary. Also, all personnel must http://www.ARCHINTERNMED.com)
have written policies and procedures be knowledgeable and trained in their identified dialysis centers as having a
that specifically define the handling of respective roles in emergency situations. relatively high incidence of cardiac
emergencies that may threaten the We are proposing that staff training arrest (≥ 0.746 per practice annually). In
health and safety of patients. The must be evaluated at least annually and the 9 dialysis facilities studied there
existing regulations also stipulate that that staff must demonstrate knowledge were 47 cardiac arrests over a 7-year
facility staff should be trained for any of emergency procedures. This period. Approximately 56 percent, or 26
emergency or disaster, as part of their requirement is designed to ensure the patients, had ventricular fibrillation and
employment orientation. safety and security of both the patients may have benefited from use of an AED.
We propose to clarify at § 494.60(d) and the staff. We propose also to require The authors of this study presented
that each dialysis facility must that the facility provide periodic their findings to the nine dialysis
implement emergency preparedness training to patients and staff. Patients centers and all nine agreed to equip
procedures to manage potential medical routinely treated in dialysis units are at their centers with AEDs and to train
and nonmedical emergencies that are risk for medical emergencies. As a their staff in the use of AEDs.
likely to threaten the health or safety of result, standard medical practice The key to saving a life is getting the
facility patients, the staff, and the dictates that the facility must have defibrillator on the patient as soon as
public. These emergencies include, but trained personnel, drugs, and possible. The AED allows dialysis
are not limited to, fire, equipment or emergency equipment available to facility staff to defibrillate a patient
power failures, care-related adequately support patients until an without requiring the immediate
emergencies, water supply interruption, Emergency Medical System (EMS) unit presence of a physician. According to
and natural disasters likely to occur in responds to the facility. the American College of Emergency
the facility’s geographic area. The We are proposing at § 494.60(d)(1)(ii) Physicians (www.acep.org/
facility will need to identify which that staff must maintain current
1,2891,0.html), when a person suffers a
hazards are most likely to effect their cardiopulmonary resuscitation (CPR)
sudden cardiac arrest, the chance of
facility, evaluate how to minimize risks, certification. This is the standard
survival decreases by 7 to 10 percent for
and plan how to best protect patients in practice in United States dialysis
each minute that passes without
the event of an emergency, using an facilities. We have not prescribed the
emergency management approach. We type or number of staff who must defibrillation. The very real potential for
do not expect individual facilities to maintain CPR certification but at a saved lives supports the financial
develop emergency plans for natural minimum, the patient care staff must investment in an AED. The cost of an
disasters that typically do not affect maintain current CPR certification. In AED is approximately $2,000 to $3,000.
their geographic location. For example, this instance, patient care staff are staff Some units have already voluntarily
facilities located in the Southeast would who routinely provide direct medical purchased AEDs. Very small units (for
not typically need to develop emergency care to patients in the dialysis unit. example, units with two hemodialysis
procedures for earthquakes. Facilities We would maintain the standard in stations) may find the purchase of an
located in the central plains States, on the existing regulation (§ 405.2140(d)(5)) AED to be a heavy financial burden. We
the other hand, would need to be that the facility provides appropriate are soliciting comments on whether
prepared for tornadoes. All facilities training to patients, so that they know small, predominantly rural dialysis
must plan for fire, care related the facility’s emergency procedures, facilities should receive special
emergencies, equipment and power since they may need to take steps to consideration and possibly an
failures, and interruption of the water protect themselves during an exemption from the defibrillator
supply, because these emergencies may emergency. Dialysis patients need to be requirement. We propose that the
occur regardless of a facility’s informed on what to do, where to go, dialysis nursing staff must be trained on
geographic location. whom to contact from home, and how the proper use of emergency equipment
In addition to having emergency to disconnect themselves from dialysis and emergency drugs. Staff could be
procedures, a facility will need to plan equipment if an emergency occurs. trained on the use of an AED in
ahead so that necessary information and The existing text in § 405.2140(d)(3) conjunction with the CPR training.
tools are available to staff and patients. requires that the facility have available Having the right equipment at the time
For example, a facility would need to at all times on the premises a fully of an emergency is only useful when
have current patient telephone numbers, equipped emergency tray, including staff is well versed in how to effectively
addresses, and transportation emergency drugs, medical supplies, and use it. In addition, the facility must have
a plan to obtain EMS assistance when detail regarding the appropriate occupancy but less than a health care
needed. procedures that must be followed. occupancy such as a hospital or nursing
We are proposing to require a We are proposing at § 494.60(e) to home.
defibrillator without specifying an AED adopt the 2000 edition of the National Under our proposal, an outpatient
due to the fact that some dialysis units Fire Protection Association’s (NFPA) dialysis facility would comply with the
already have access to a defibrillator. Life Safety Code (LSC). The LSC is a business occupancy provisions in
Hospital-based dialysis units, in compilation of fire safety requirements Chapters 38 (that is, the new business
particular, may have immediate for new and existing buildings and is occupancies) and 39 (that is, existing
physician availability built into the updated and published every 3 years by business occupancies) with the
hospital-wide cardiac resuscitation the NPFA, a private, non-profit additional provisions contained within
plan. This reduces the financial burden organization dedicated to reducing loss Chapters 20 and 21. Where there may be
of the proposed defibrillator of life due to fire. a conflict between the business
requirement. The Medicare and Medicaid occupancy chapter and the ambulatory
We are proposing to maintain the conditions of participation have health care occupancy chapter, the more
requirement that facilities conduct historically incorporated by reference stringent requirements would apply
reviews of their emergency and disaster these requirements along with (LSC sections 20.1.1.1.2 and 21.1.1.1.2).
plans to ensure that facilities Secretarial waiver authority. The The requirements of Chapters 20 and 21
appropriately respond to the situations statutory basis for incorporating NFPA’s are described below.
and needs that may arise from a variety LSC for ESRD facilities falls under the Chapter 20.1.2.1 and Chapter 21.1.2.1
of emergencies, medical and Secretary’s general rulemaking require 1-hour fire separation between
nonmedical. We are proposing in authority. different occupancies or tenants in a
The 2000 edition of the LSC is multi-tenant building. We believe most
§ 494.60(d)(3)(ii) that facilities review
divided into several occupancy chapters dialysis facilities currently meet this
their emergency and disaster plans at
including a business chapter, requirement because most State
least annually. Drill and emergency
educational chapters, ambulatory health building codes already require this
episodes often reveal a weakness or flaw
care occupancy chapters, and health provision.
in the design of the emergency plan. An care occupancy chapters. The business Chapters 20.2.4 and 21.2.4 require
annual update will allow such flaws or occupancy chapter pertains to clinics that there be at least two emergency
potential problems to be identified and and offices. The educational occupancy exits. Emergency lighting is required by
corrected. chapters pertain to schools and day care Chapters 20.2.9.1 and 21.2.9.1 to ensure
Existing § 405.2140(b)(3) specifies that centers. The health care occupancy that the center is lighted and that egress
the facility have a nursing/monitoring chapters pertain to inpatient health care paths are illuminated to allow
station from which adequate facilities (for example, hospitals, movement during an emergency.
surveillance of patients receiving nursing homes). Finally, the ambulatory Chapters 20.2.9.2 and 21.2.9.2 require
dialysis services can be made. We health care occupancy chapters pertain an essential electrical system. This
propose to delete this requirement to facilities that provide outpatient provision does not apply to dialysis
because we believe this is not a physical medical treatment that may render the facilities because dialysis equipment is
environment issue. It is important that patient temporarily incapable of self- not life-support equipment under the
patients are appropriately monitored preservation (for example, critical Life Safety Code.
during the dialysis session. However, access hospitals, dialysis centers). Chapters 20.3.4.4 and 21.3.4.4 require
monitoring is most effectively done The NFPA LSC Handbook specifically the fire alarm system to provide
through interaction between the patients designates Chapter 20 and Chapter 21 automatic notification of a fire to
and the staff in the dialysis area and not for outpatient dialysis services. We emergency forces. This is of great
from a monitoring station. propose to adopt, as recommended by importance for the protection of
We believe that existing the NFPA LSC, Chapter 20 (that is, new patients. Any delay in the notification of
§ 405.2140(b)(5) is another process- ambulatory health care occupancy fire and rescue personnel could
oriented requirement, and we propose buildings) and Chapter 21 (that is, adversely impact the health and safety
to delete this requirement. This existing ambulatory health care of patients and expose them to a fire,
requirement states that facilities using occupancy buildings) of the 2000 smoke, or toxic gases created by the fire.
central batch processing must make edition of the LSC for all outpatient Chapters 20.3.7 and 21.3.7 pertain to
arrangements to meet the needs of dialysis facilities regardless of size. smoke compartmentation, otherwise
patients with special dialysis solutions. The LSC classifies dialysis facilities as known as subdivision of building space.
The Patient plan of care condition, ambulatory health care occupancies Section 3.7 of Chapters 20 and 21 apply
proposed § 494.90, would require the because the treatment is not a routine to any dialysis facility that is larger than
dialysis facility to implement the care medical visit to a doctor’s office but 5,000 square feet (or 10,000 square feet
plan and make arrangements to meet the rather a procedure that may hinder the for facilities with sprinklers). We
individual requirements of each patient patient from self-preservation in the believe most dialysis facilities will fall
regardless of whether those needs are event of an emergency or fire. within the exceptions outlined in this
related to special dialysis solutions or Incapability of self-preservation might provision. If a dialysis facility is smaller
other medically necessary supplies or be the result of the use of general that 5,000 square feet and protected by
equipment. anesthesia or a treatment such as an approved, supervised sprinkler
The existing emergency preparedness dialysis. Dialysis patients are not as system, then section 3.7 of Chapters 20
standard (§ 405.2140(d)) enumerates the mobile as a person working or visiting and 21 do not apply.
facility physical emergency an office building or health clinic but Section 7 of Chapters 20 and 21
management procedures but provides more mobile than patients being treated specify procedures to assist outpatient
minimal standards for the procedures in an inpatient health care facility, such dialysis facilities in providing fire
that must be followed during a fire. We as a hospital or nursing home. Chapters safety. Section 7.1 of Chapters 20 and 21
propose to strengthen the section 20 and 21 give a level of safety from fire propose evacuation plans and fire exit
governing fire safety to provide greater that is greater than the typical business drills and require staff to practice the
procedures outlined in the dialysis construction, repair and improvement Sections 405.2138(b)(1) and (2) afford
facilities written emergency plans. operation (20.7.9 and 21.7.9). patients the right to participate in
Section 7.1 of Chapters 20 and 21 are We recognize that for some dialysis planning their medical treatment;
appropriate for outpatient dialysis facilities it would be extremely require that a patient may be transferred
facilities because there is a possibility a burdensome to adhere strictly to all of or discharged for only medical reasons
dialysis patient could lose blood or the LSC requirements. For example, or for the patient’s or other patient’s
suffer unnecessary risks if the patient older dialysis facilities or facilities welfare or nonpayment of fees; and
were removed from the dialysis leasing space in an office building may require that patients must be given
machine during a fire drill. We believe not be able to add sprinkler systems. We advance notice to ensure an orderly
that requiring a dialysis facility to stop are proposing to retain our existing transfer or discharge. Section
dialysis treatment and evacuate all authority to waive specific provisions of 405.2138(c) states that patients must be
dialysis patients during a fire drill is an the LSC on a case-by-case basis, further treated with respect and dignity;
unnecessary procedure that could reducing the exposure to additional cost § 405.2138(d) protects patient
jeopardize the dialysis patient’s health and burden for facilities with unique confidentiality of personal and medical
and safety. Annex A, Explanatory situations that can justify the records; and § 405.2138(e) states
Material to the 2000 NFPA LSC application of waivers which we patients must be advised, encouraged,
provides guidance for conducting fire determine will not endanger the health and assisted in exercising their rights to
drills when it is inexpedient and and safety of patients. We propose that bring grievances (through a
impractical to move patients during a a waiver may be granted for a specific representative, if desired) without fear
fire drill. Many health care occupancies LSC requirement if: (1) We determine of discrimination or reprisal.
conduct fire drills by choosing the that the waiver would not adversely We are proposing to revise the
location of the simulated emergency in affect the patient/staff health and safety; provisions of this condition to include
advance; practicing the movement of and (2) we determine that it would a number of changes, in keeping with
simulated patients or empty impose an unreasonable hardship on the our goals to reduce the Federal
wheelchairs to adjacent safe areas, and facility to meet a specific LSC regulatory burden on dialysis facilities,
ensuring that staff have the efficiency, requirement. A provider may request a eliminate unnecessary procedural
knowledge, and response capability to waiver from its State Agency. The State requirements, and revise the conditions
implement the facility’s fire emergency Agency will review the request and for coverage to be more outcome-
plan. Surveyors may determine whether make a recommendation to the oriented while protecting the basic
this standard was met by checking a appropriate CMS Regional Office. The rights of ESRD patients.
dialysis facility’s records and CMS Regional Office will review the First, we are proposing at § 494.70
waiver request and the State Agency’s that the facility must inform patients (or
interviewing staff to verify that the
recommendation and make a final their representatives) of their rights and
emergency and fire drills were
decision on the waiver request. A responsibilities when they begin their
conducted not less than once in each 3-
waiver cannot be granted if patient treatment at the facility, and must also
month period and that staff are very
safety is compromised in any way. protect and provide for the exercise of
familiar with the procedures.
A State may also request that a State those rights. We believe it is important
Section 7.1.1 in Chapters 20 and 21 to take steps to ensure that patients are
also require that the dialysis facility fire and safety code, imposed by State
law, be applicable to all dialysis fully and promptly informed of their
prominently post its emergency plan. rights. The existing regulatory language
We expect the plan to include facilities rather than the LSC proposed
in this rule. The State must submit the permits a facility an unspecified period
continuity of essential building of time to complete this activity.
operations in the event of an emergency. request to its CMS Regional Office and
However, we believe that all dialysis
Electrical, water, fire protection, the Regional Office will forward the
patients must be informed of their rights
ventilation, and communications State’s request to CMS Central office for
and responsibilities when they begin
systems are some, but not all, areas a a final determination.
their treatment, which is the standard
dialysis facility should consider in its V. Proposed Part 494 Subpart C (Patient practice in dialysis facilities, so they
disaster plan. A good reference, but not Care) may exercise them from the beginning
a requirement for developing an of their relationship with the facility.
emergency plan for a dialysis facility, is A. Patients’ Rights (§ 494.70) Existing § 405.2138 provides a list of
the NFPA 99—Standard for Health Care [If you choose to comment on issues in numerous persons to whom these
Facilities, Chapter 11, Health Care this section please include the caption written patient rights policies must be
Emergency Preparedness (NFPA, ‘‘Patients’ Rights’’ at the beginning of ‘‘made available.’’ The list includes
November 2001). Our intent in your comment.] patients and guardians, next of kin,
proposing the posting requirement is to The existing patients’ rights sponsoring agencies, representative
ensure patients, staff and the public condition, § 405.2138, requires that the payees, and the public. Essentially, the
have the proper information to quickly facility’s governing body adopt written facility must provide the list of patient
evacuate in the event of an emergency. patients’ rights policies that are rights to anyone who asks to see them.
The remaining provisions in section 7 administered by the facility’s chief Rather than specifying a list of people
of Chapters 20 and 21 include executive officer (CEO). Sections to whom the patients’ rights policies
requirements for the procedures in case 405.2138(a)(1) through (5) state that must be made available, we are
of fire (20.7.2 and 21.7.2); maintenance patients must be informed regarding the proposing at § 494.70 that facilities
of exits (20.7.3 and 21.7.3); smoking following: (1) Their rights and inform the patients (or their
regulations (20.7.4 and 21.7.4); responsibilities; (2) services available at representatives), and at § 494.70(c) that
furnishings, beddings, decorations the facility and charges not covered; (3) facilities post a copy of the patients’
(20.7.5 and 21.7.5); maintenance and their medical condition (by a rights in a prominent location where it
testing of life safety-related equipment physician); (4) the facility’s reuse can easily be seen and read. This not
(20.7.6 and 21.7.6); portable space policies; and (5) their suitability for only meets the objectives of the current
heating devices (20.7.7 and 21.7.7); and transplantation or home dialysis. list of disclosures, it also allows patients
to review their rights at any time during as the patient’s medical records. These Proposed § 494.70(a)(5) would also
the course of their care at the dialysis requirements include existing require the facility to inform patients of
facility. provisions from § 405.2138(c) and (d). the right to establish an advance
Section 405.2138 also states that the Staff should be instructed that any directive. Advance directives establish
CEO is responsible for the development discussions with dialysis patients or in writing an individual’s preference
of, and adherence to, procedures relatives regarding treatment, the patient with respect to the degree of medical
implementing the patients’ rights care plan, and medical conditions care and treatment desired or who
policies. In § 494.70, we are proposing should be held in private and kept should make treatment decisions if the
to change this requirement by holding confidential. There should be individual should become incapacitated
the facility accountable for the outcome, reasonable precautions to keep both and lose the ability to make or
which is to ensure that each patient’s written and verbal patient information communicate medical decisions.
rights and the ability to exercise them private. Staff should be aware of the Advance directives include written
are protected. need to speak at a volume and at a documents including living wills and
We are proposing to retain the proximity to patients such that privacy durable powers of attorney for health
patients’ rights enumerated in is reasonably protected. Facility staff
§ 405.2138(a)(1) through (a)(5) and care, as recognized by State law.
must make efforts to protect patient
include them in the proposed information and physical privacy. While Congress passed section 4206 of the
§ 494.70(a). recognizing the patient’s right to privacy Omnibus Budget Reconciliation Act of
Proposed § 494.70(a)(1) requires the and confidentiality, we are not 1990 (OBRA 1990) (Pub. L. 101–508) to
dialysis facility to inform patients of necessarily advocating physical barriers ensure that patients receive information
their right to be treated with respect, in the dialysis clinical area that provide regarding their right to execute or not to
dignity, and recognition of their patient privacy because patients should execute advance directives. While the
individuality and personal needs as be in view of staff at all times during OBRA 1990 requires hospitals, skilled
well as sensitivity to the patients’ treatment to ensure safety. However, in nursing facilities, HHAs, managed care
psychosocial needs and ability to cope situations when there is patient body plans, and hospice programs
with ESRD. exposure during therapy, the staff participating in the Medicare program to
Proposed § 494.70(a)(2) requires a should be instructed to provide establish and maintain written policies
dialysis facility to provide information temporary screens, curtains, or blankets. and procedures regarding advance
to patients in an understandable We are proposing at § 494.70(a)(5) to directives, it does not specifically
manner. The existing requirement at retain the existing requirement under mention dialysis facilities.
§ 405.2138(c) requires dialysis facilities § 405.2138(b)(1) that describes the right
to provide translators ‘‘where a of patients to participate in the planning In proposing to add advance
significant number of patients exhibit of their medical treatment and to refuse directives to the patients’ rights
language barriers.’’ Presumably, under to participate in experimental research condition for coverage we took several
this existing requirement, if a single (or any part of their care). Section factors into consideration. First is the
patient has language difficulty, the 494.70(a)(5) requires a facility to inform chronic nature of ESRD. Kidney
facility does not need to act to address patients regarding their right to impairment is irreversible and
this patient’s needs. We are proposing to participate in all aspects of their care. permanent, and a regular course of
modify this requirement. Since written Although we recognize that a facility dialysis or transplantation is essential to
information is not required, the dialysis cannot require its patients to participate maintain life. In addition, we
facility has the flexibility to decide the in the care process, we expect the considered the amount of time a patient
best vehicle for providing information to facility to work closely with patients spends in the dialysis unit, and also the
patients. We believe this more outcome- and encourage patient participation to rapidly changing demographics of the
oriented requirement provides a facility ensure that a care plan is developed that ESRD patient population. The average
with the latitude to devise its own is suitable to the needs and concerns of age of the ESRD patient population is
means to ensure the outcome is met. both the patient and staff. The facility increasing annually. Elderly ESRD
Proposed §§ 494.70(a)(3) and (4) should notify patients in advance, if patients now comprise a large
would require a dialysis facility to possible, of any changes in the percentage of the total ESRD patient
inform patients regarding privacy and treatment plan recommended by the population. Data compiled by the
confidentiality, and also expands those physician and the basis for the changes. United States Renal Data System, from
rights to include specific references to The facility should also encourage 1990 to 2001, shows the following rate
privacy and confidentiality in all patients to disclose any concerns they of new cases of ESRD for patients 65
aspects of the patient’s treatment as well may have with the proposed changes. years of age and older:
Year
Age
(in years) 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001
65–69 ............................... 7,177 7,982 8,597 8,895 9,852 9,643 10,390 10,829 11,078 11,225 11,415 11,545
70–74 ............................... 6,159 7,260 8,093 8,533 9,664 9,678 10,753 11,248 11,648 12,005 12,276 12,367
75–79 ............................... 4,587 5,367 5,997 6,293 7,243 7,404 8,481 9,339 10,133 11,170 11,407 11,408
80–84 ............................... 2,386 2,754 3,228 3,427 4,051 4,290 4,959 5,725 6,125 6,785 7,349 7,477
85+ ................................... 961 1,113 1,277 1,481 1,659 1,833 2,248 2,598 3,110 3,587 3,870 4,146
The emergence of an older, sicker implementation of advance directives in advance directives. The guidelines can
ESRD patient population has motivated dialysis facilities, and we are be obtained through the NKF’s Web site
the Renal Physicians Association (RPA) encouraging dialysis facilities to adopt at: http://www.kidneyva.org/public_ed/
and the NKF to develop guidelines for voluntary consensus guidelines for orderforms.pdf and through the RPA
Web site at http://www.renalmd.org/ Proposed § 494.70(a)(11) would discharges from facilities for
publications/index.cfm. require that patients be informed of the noncompliance or disruptive behavior.
After taking these factors into right to receive the necessary services We would not expect a patient to be
account, we believe it is prudent to outlined in the patient plan of care in involuntarily discharged from a dialysis
consider adding advance directives as a proposed § 494.90. The importance of facility for failure to follow the
requirement in the patients’ rights the patient plan of care is discussed in instructions of a facility staff member.
condition of this proposed rule. section V.C. of this preamble. However, it may be necessary to
Existing § 405.2138(a)(5) requires that Proposed § 494.70(a)(12) would retain discharge a disruptive patient in order
patients be informed of their suitability the existing requirement at to protect the rights and safety of other
for transplantation or home dialysis. We § 405.2138(a)(1) that patients be patients in the facility, or to protect the
have strengthened this requirement at informed of the rules and expectations safety of facility staff.
§ 494.70(a)(6) by proposing that patients of the facility regarding patient conduct We believe that a dialysis facility has
be informed about alternative treatment and responsibilities. The success of the both the resources and a responsibility
modalities by requiring dialysis dialysis treatment is as contingent upon to make a good faith effort to work with
facilities to address all treatment patients adhering to their every patient, including patients
choices. The treatment modality responsibilities as it is upon other perceived to be disruptive or
selected may directly affect the quality important factors. There is a discussion challenging, to provide the necessary
of life for dialysis patients. This choice of the dialysis facility’s responsibility assessment, training, knowledge, and
is a very personal one, with important regarding disruptive and difficult motivation to facilitate good outcomes
implications for how likely the patient patients in section VI.E.9. of this of care. This process begins when the
is to be rehabilitated to the highest preamble. facility interdisciplinary team performs
possible level. To assist dialysis patients Proposed § 494.70(a)(13) would the comprehensive patient assessment
in achieving the optimal quality of life, require facilities to inform patients described in proposed § 494.80, with
patients need education about each regarding the facility’s internal periodic reassessments as needed;
modality and must have access to the grievance process and their right to continues through the care planning
widest array of treatment choices express grievances against the facility process described in proposed § 494.90;
possible. using the internal grievance process as well as the facility’s quality
For example, a successful kidney through a representative chosen by the assessment and performance
transplant is the most desirable patient (if so desired). improvement (QAPI) program described
treatment for many ESRD patients and Proposed § 494.70(a)(14) strengthens in proposed § 494.110. We believe the
facilities should make every effort to the existing requirement for facilities to disruptive or challenging patient
both educate and inform patients inform patients regarding the various problem is multifaceted, and even
regarding the transplantation option. external grievance mechanisms conscientious assessments, care
Also, forms of dialysis that can be available to them, including how to planning, and QAPI programs by a
performed at home have been shown to contact the ESRD network and the State facility will not always be successful in
have a positive influence on the survey agency, and how to file external mitigating the disruptive behavior of
patient’s quality of life. Home dialysis grievances without reprisal or denial of some patients. In those instances when
affords patients’ control over scheduling services, through a representative good faith efforts by a facility have been
and setting, and it can be done in chosen by the patient or anonymously unsuccessful and the facility has
comfortable, familiar surroundings. (if so desired). We believe that patients determined that it wants to discharge or
Also, home dialysis is generally must be made aware of every grievance transfer the patient, facilities must
perceived to be less disruptive to family option available to them, including, at a follow the procedure outlined in
life and employment. We propose to minimum, contacting the two entities proposed § 494.180(f), and arrange to
require that a facility inform patients with the statutory responsibility under transfer or discharge the patient, as
about all available treatment modalities Federal law for addressing patient appropriate.
and settings, so patients can make an grievances (that is, the ESRD networks We also recognize there will be rare
informed decision regarding the most and the State survey agencies). instances when a facility must act
appropriate course of treatment that In proposed §§ 494.70(b)(1) and (2), immediately to discharge a patient.
meets their needs. we would require a facility to inform Such instances could be, for example,
Open communication between the patients regarding its transfer and when a patient physically harms or
facility staff and the patient and patient discharge policies and provide 30 days threatens other patients and staff, a
access to treatment information are vital notice in advance of reducing or patient who brings weapons or illegal
tools for enhancing the patient’s terminating patient care services drugs into a facility, or a patient who is
participation in his or her coordinated following the discharge and transfer verbally abusive and disruptive to such
care planning. Proposed § 494.70(a)(7) procedure outlined in § 494.180(f). The an extreme degree that the facility is
requires that patients be informed of the facility would be exempt from the 30- unable to operate effectively. In those
facility’s patient care policies, including day notification requirement in cases and comparable circumstances, we
its patient isolation policies. when there was an immediate threat to would propose to shorten the 30-day
Proposed §§ 494.70(a)(8) through (10) the health and safety of others. Proposed notification requirement. We are
retain existing requirements in §§ 494.70(b)(1) and (b)(2) and the soliciting comments on the proposed
§ 405.2138(a)(2) through (4) that patients procedure outlined at § 494.180(f) have §§ 494.70(b)(1) and (b)(2), as well as
be fully informed regarding the facility’s been proposed, in part, in response to suggestions for addressing the
reuse of dialysis supplies, including the ‘‘disruptive’’ or ‘‘challenging’’ disruptive or challenging patient issue
hemodialyzers; be informed by a patient issue. Increasing numbers of in the proposed ESRD conditions.
physician regarding his or her own staff and patient grievances presented to If a patient chooses not to use a
medical condition unless the ESRD networks and the State survey facility’s internal grievance process, or
contraindicated; and be informed of agencies involve allegations of when grievances cannot be resolved at
services available in the facility and disruptive behavior by patients and the facility level, the patient may elect
charges not covered by Medicare. allegations of inappropriate patient to register a grievance with the
appropriate ESRD network or make a assessment. Over the past 25 years, • Evaluation of current health status,
complaint directly to the State survey research has improved our knowledge of including comorbid conditions and
agency at any time. We believe it is the components important to assessing medical condition.
essential that we require that patients be and treating the dialysis patient so that • Evaluation of the appropriateness of
informed of every grievance and improvements in quality of life and the dialysis prescription, blood pressure
complaint option currently available to morbidity and mortality rates have been control, and fluid management needs.
them under the law. achieved. • Laboratory profile and medication
Proposed § 494.70(c) would require We believe that a comprehensive history.
dialysis facilities to prominently display patient assessment that includes clinical • Evaluation of factors associated
a copy of the patients’ rights as well as interaction with the patient is a with anemia, such as hematocrit,
the telephone numbers for the prerequisite for the delivery of quality hemoglobin, iron stores, and potential
appropriate ESRD network and State care and is the basis for determining a treatment plans for anemia, including
survey agency in order to afford patients patient’s functional status and administration of recombinant
the opportunity to contact either entity, identifying the services necessary to erythropoietin.
if desired. Dialysis patients have the address the patient’s needs. Accurate • Evaluation of factors associated
right to be advised of and to use and accessible patient information with renal bone disease.
grievance processes developed by the generated from the comprehensive • Evaluation of nutritional status.
facility, the ESRD network and the State assessment is critical to the • Evaluation of psychosocial needs.
survey agency. development of a successful patient care • Evaluation of dialysis access type
plan and the achievement of desired and maintenance.
B. Patient Assessment (Proposed • Evaluation of the patient’s ability,
patient outcomes.
§ 494.80) We do not believe that expanding the interests, preferences, and goals,
The proposed patient assessment existing requirements in this proposed including level of participation in the
condition at § 494.80 underscores our condition will impose any additional dialysis care process; modality and
belief that systematic patient assessment burden on facilities. Rather, we believe setting (for example, home dialysis,
is essential to improving quality of care quality-oriented facilities already including home hemodialysis or
and patient outcomes. The information routinely perform comprehensive peritoneal dialysis); and expectations
generated from the patient assessment is patient assessments upon initiating for care outcomes.
a vital tool for developing a patient’s treatment. Further, we believe most • Evaluation of suitability for
care plan and subsequent treatment. A facilities already have this information transplantation referral, based on
comprehensive patient assessment in different parts of the medical record criteria developed by the transplant
allows the dialysis facility to monitor since an appropriate and effective surgeon at the transplant center that
the patient’s progress toward achieving treatment plan cannot be developed would receive such transplantation
the desired care outcomes and adjust without an initial assessment. referral including the basis for referral
the plan of care and treatment We are proposing at § 494.80 to add or nonreferral.
prescription as necessary. a patient assessment condition for • Evaluation of family and other
The existing regulations in part 405 coverage that would make the ESRD support systems.
subpart U do not state that a patient will facility, through the patient’s • Evaluation of current physical
receive a comprehensive assessment. interdisciplinary team, responsible for activity level.
However, two sections of the existing providing each of its patients with an • Evaluation of vocational and
regulations, §§ 405.2136(g)(1) and individualized and comprehensive physical rehabilitation status and
405.2137(b)(1), provide a basis for a assessment of his or her needs. The potential.
patient assessment. For example, members of the interdisciplinary team Other information to be included in
§ 405.2136(g)(1) holds the patient’s (see proposed § 494.10) would include the initial assessment would be
physician responsible to prescribe a the patient (if he or she chooses), a determined by the interdisciplinary
planned regimen of care, ‘‘which covers registered nurse, a physician, a social team based on the specific
indicated dialysis and other ESRD worker, and a registered dietitian. With characteristics and needs of the patient.
treatments, services, medications, diet, the team concept, the goal is to obtain We recognize that inclusion of a
special procedures recommended for input from each designated health minimum set of assessment criteria may
the health and safety of the patient, and professional as well as from the patient appear to be inconsistent with our goal
plans for continuing care and to develop an assessment that identifies of eliminating unnecessarily
discharge.’’ That section also states that the patient’s needs and allows for prescriptive and process-oriented
such plans are made with the input of planning for necessary services. The requirements. However, we believe it is
the professional personnel providing proposed team members represent vital appropriate and necessary for every
care to the patient. Existing components of the patient’s medical patient assessment to focus not only on
§ 405.2137(b)(1) states that a patient care treatment and psychosocial the patient’s medical needs, but also on
plan ‘‘reflects the psychological, social, development. These professionals are his or her psychosocial and
and functional needs of the patient,’’ also key to a successful transition to rehabilitation needs. Further, these
and indicates ESRD and other care dialysis as well as to maintaining the assessment criteria would assure that
needed to achieve the long- and short- patient’s quality of life. An assessment needed information would be available
term treatment goals. that involves the patient as a key for the patient plan of care and the
Therefore, while the existing member of the interdisciplinary team is facility’s quality assurance and
regulations indicate that a specialized important to the successful delivery of performance improvement program.
care plan must be developed based service and the patient’s adherence to We propose criteria for the frequency
upon the nature of the patient’s illness, the program. of assessment and reassessment of new
the treatment prescribed, and an In proposed § 494.80(a), we list the patients in §§ 494.80(b)(1) and (2). A
assessment of the patient’s needs, it assessment criteria. The minimum timely, comprehensive assessment is
does not specify the criteria that a proposed elements of a patient’s critical for planning patient care and
facility must include in a patient assessment include the following: achieving desired patient outcomes. We
believe this requirement, though Quality Initiative (NKF–K/DOQI). As facility burden because the existing
process-oriented, is necessary to prevent previously discussed in this preamble, § 405.2137(b)(4) requires care plan
harm to the patient. By permitting the NKF–K/DOQI has established review every 6 months for stable
facilities 20 calendar days to complete clinical practice guidelines for ESRD patients. If the patient is unstable, we
assessments, we are providing a patients. This systematic, evidence- are proposing in § 494.80(d)(2) to
reasonable timeframe for every member based approach to developing require a monthly reassessment, to
of the team to assess the patient prior to guidelines used focus workgroups to allow for the update of the plan of care.
development of the treatment plan. identify target issues and conducted Existing § 405.2137(b)(4) also requires a
We also recognize that patients who extensive literature searches to extract monthly review of the care plan for
are new to dialysis need time to adjust relevant clinical study reports for each patients whose medical condition has
and adapt to the treatment. Initially, target issue. Clinical practice guidelines not become stabilized. In proposed
patients may experience a great deal of were derived from this information. The §§ 494.80 (d)(2)(i) through (d)(2)(iv), we
anxiety while learning self-care skills, guidelines are available for public added criteria to specify at a minimum,
modifying their diet, changing their review and comment, and they continue which patients may be considered to be
behavior, and perhaps dealing with to be reviewed. Health care unstable patients. These criteria include
access issues. The level of compliance professionals and providers, ESRD extended or frequent hospitalizations,
with the renal regimen may be set by the networks, managed care groups, marked deterioration in health status, a
time the person has been on dialysis for industry, government, patient significant change in psychosocial
4 to 6 months (Sciarini, pp. 299–305). associations and individuals are invited needs, or poor nutritional status, with
Because of this period of adjustment, to provide comments to the NKF–K/ unmanaged anemia and inadequate
and the opportunity to establish the DOQI workgroups. These comments are dialysis. Extremely frail patients may
patient’s adherence to the renal reviewed and when appropriate, need monthly reassessments. However,
regimen, proposed § 494.80(b)(2) would incorporated in future editions. we are not proposing a specific
require a follow-up comprehensive An important initiative of this project requirement for monthly reassessments
reassessment for new patients within 3 is the development of guidelines for the for frail patients because we believe this
months after the completion of the dose of dialysis, including standard type of requirement would be too
initial comprehensive assessment. Three methodology(ies) for measuring the prescriptive and limit the flexibility of
months was chosen so that the window dialysis dosage. dialysis facilities to make clinical
of opportunity for establishing To ensure that ESRD patients receive determinations on a case-by-case basis.
adherence to the renal regimen by a new sufficient dialysis, the delivered dose of The renal community has been unable
patient is not missed. We recognize the dialysis needs to be measured. to reach a consensus regarding the
additional burden this 3-month Therefore, in keeping with the NKF’s K/ optimum frequency of assessments.
reassessment will place on the DOQI clinical practice guidelines, we Some believe that the proposed time
interdisciplinary team. However, an propose in § 494.80(c) to specify that the periods create a strain on facilities,
updated plan of care and the attention delivered dose of dialysis for the while others have encouraged us to
to the patient’s adjustment to the renal patient’s hemodialysis treatment propose more stringent timeframes.
regimen may prevent problems in the prescription must be measured at least Because of the wide range of opinion in
coming months. The reassessment also monthly, and the patient’s peritoneal this matter, we are specifically soliciting
ensures the continued accuracy and dialysis treatment prescription should public comments on whether the
effectiveness of the treatment regimen. be assessed at least every 4 months. proposed 3-month timeframe for
Existing § 405.2136(g) states that the More frequent monitoring may be reassessment of new patients is
physician responsible for the patient’s necessary for new dialysis patients or reasonable and consistent with meeting
medical supervision evaluates the when the dialysis prescription is the patient’s needs.
patient’s needs and prescribes a planned changed. Less frequent monitoring of
regimen of care for dialysis. Sections the adequacy of dialysis may C. Patient Plan of Care (Proposed
494.80(c)(1) and (2) propose a schedule compromise the timeliness with which § 494.90)
for the assessment of the treatment deficiencies in the delivered dose of [If you choose to comment on issues in
prescription for hemodialysis and dialysis are identified and hence may this section please include the caption
peritoneal dialysis patients. Studies delay implementation of corrective ‘‘Plan of Care’’ at the beginning of your
indicate that ESRD patient mortality is action. comments.]
lower when patients receive sufficient In §§ 494.80(d)(1) and (2) we propose The patient assessment serves as the
dialysis treatments. There has been patient reassessment timeframes for basis for the patient plan of care.
considerable research recently both stable and unstable patients with Existing § 405.2137 contains a large
indicating that the dose of dialysis is an respect to the standards specified in number of prescriptive requirements for
important determinant of survival and §§ 494.80(a)(1) through (a)(13). The the development of patient care plans.
morbidity of patients on hemodialysis comprehensive assessment process can These requirements specify that there
((Held, pp.871–875); (Owen, pp.1001– be seen as part of a cycle. Through the needs to be a patient long-term program
1006); (Parker, pp.981–989); and use of the patient assessment, accurate and a patient care plan.
(Parker, pp.670–680)). The delivered and timely patient information is The patient long-term program
dose of dialysis (Kt/V or an equivalent reflected in the plan of care. As the described in existing §§ 405.2137(a)(1)
measure) indicates how well the assessment changes, the plan of care through (a)(4) relates to the selection of
dialysis treatment is working. Kt/V is must be revised accordingly. If the a suitable treatment modality and
the dialyzer clearance of urea (K) times patient’s condition is stable, we propose treatment setting by the treatment team.
the time of treatment (t), divided by the in § 494.80(d)(1) that the facility must It also requires active participation by
volume of distribution of urea (V), perform comprehensive reassessments the physician director in the unit where
which yields a dimensionless value. at least annually, which assures that the patient is being treated, a formal
Adequacy of dialysis clinical practice patients are receiving a continuing review of the written long-term plan by
guidelines are available in the National program of care that meets their needs. the team every 12 months, patient
Kidney Foundation’s Kidney Disease This proposed timeframe minimizes the involvement in the plan’s development,
and a requirement to send the plan to patient’s needs. We are proposing in surgeon in developing the patient plan
the receiving facility within 1 day of an § 494.90 to retain the existing of care.
interfacility transfer. requirement that the patient plan of care Existing § 405.2137(a)(1) also requires
The patient care plan in existing to be developed by the interdisciplinary that the facility medical director and a
§ 405.2137(b) requires a written care team. Although we would retain the physician from a facility that offers
plan based on the nature of the patient’s existing §§ 405.2137 (a)(1) and (2), we home dialysis (if the patient’s present
illness, the treatment prescribed, and an have chosen to use the term facility does not) be included in the
assessment of the patient’s needs. ‘‘interdisciplinary team.’’ The term team that develops the patient’s long-
Additional requirements in existing ‘‘interdisciplinary team’’ is defined term program. While we believe the
§§ 405.2137(b)(1) through (b)(7) include § 494.10 and described in § 494.80. In involvement of these physicians would
a personalized care plan reflecting the § 494.80, we are proposing that the be valuable in most cases, we recognize
patient’s needs, a care plan developed interdisciplinary team consist of, at a that there are situations when the
by a professional team (including the minimum, the patient (if he or she services of these physicians may not be
physician responsible for the patient’s desires) or his/her designee, a registered needed. Thus, in keeping with our goal
care), the involvement of the patient (or nurse, a nephrologist or physician of eliminating unnecessary process
the patient’s parent or legal guardian), a treating the patient for ESRD, a social requirements, proposed § 494.10
monthly review for unstable patients, a worker, and a dietitian. We are using the specifies the definition of
6 month review for stable patients, term ‘‘interdisciplinary team’’ instead of ‘‘interdisciplinary team’’ without
sending the plan to the receiving facility ‘‘professional team’’ because the term including the facility medical director
within one day for interfacility transfers, ‘‘interdisciplinary team’’ is commonly and the home dialysis physician.
periodic monitoring of home dialysis used in health care settings, including Nonetheless, we encourage facilities to
patients, and monitoring for home dialysis facilities. expand the interdisciplinary team to
dialysis patients who use include as many health professionals as
Although existing § 405.2137(a)(1)
erythropoietin. necessary to furnish the best care
In accordance with our goal of specifies a transplant surgeon as a
possible to their patients.
reducing Federal regulatory burden, we member of the professional team, we As required in existing § 405.2137 and
have simplified the proposed patient did not include a transplant surgeon as in proposed § 494.10, a physician is part
care plan condition (§ 494.90) by a member of the interdisciplinary team of the interdisciplinary team. We
eliminating the separate requirement for as defined in proposed § 494.10 and propose retention of this requirement
a patient long-term program. described in proposed § 494.80. We because we believe the physician must
We propose to retain some of the believe all eligible ESRD patients must play an integral role on the
existing requirements of § 405.2137 in be referred for transplantation. interdisciplinary team. The physician
the patient assessment condition However, it may not be reasonable to responsible for the patient’s dialysis
(proposed § 494.80). We believe that the have transplant surgeons sign every care treatment works with the other team
patient assessment and patient care plan. The existing interpretive members to ensure the development of
planning processes are inextricably guidelines for surveyors (Survey an appropriate care plan for the patient.
linked. That is, each patient assessment Procedures and Interpretive Guidelines We also expect the physician to see the
must be followed with a review and for End-Stage Renal Disease Facilities, patients and monitor their care.
revision, if necessary, of the patient’s Appendix H, State Operations Manual) Existing § 405.2137(b)(3) specifies that
plan of care. allow a transplant surgeon’s designee, the patient may be involved in the
The comprehensive plan of care is an who could be a transplant coordinator development of the care plan and
individualized program that ensures or the treating nephrologist, to screen consideration is given to the patient’s
that each dialysis patient receives patients in the long-term care plan preferences. The patient’s right to be
personalized and appropriate patient process (DHHS/CMS, April 1995). The informed about and participate within
care within the selected modality and designee would have to use screening the interdisciplinary team is
setting of treatment. In proposed criteria developed by the transplant encompassed in proposed § 494.70(a)(5).
§ 494.90 we would specify that the surgeon. Because not every patient is The patient or his/her designee, if he or
patient’s plan of care must include medically suited for a transplant, we she desires, as a member of the
measurable and expected outcomes and believe the transplant surgeon need not interdisciplinary team, must collaborate
estimated timetables to meet the be involved with the team unless a to design a plan of care that enables the
patient’s medical and psychosocial possible candidate has been identified. patient to reach his or her desired level
needs as identified in the initial and We are proposing that the dialysis of general health, activity, and quality of
subsequent comprehensive assessments. facility must have inclusion/exclusion care. When a patient communicates his
This section would also specify that the criteria, defined by the transplant or her goals regarding their medical
patient’s plan of care must address all surgeon based at the transplant center treatment, he or she plays a more active
the services that are to be furnished to that would receive the transplantation role in improving their quality of life.
achieve and maintain the expected referral, to use in the evaluation of We have eliminated the phrase ‘‘due
outcomes of care. patients for transplant referral. consideration is given to [the patient’s]
Existing §§ 405.2137(a)(1) and Therefore, we propose to delete the preferences’’ because we believe it
405.2137(b)(2) specify the composition requirement that a transplant surgeon implies the patient (or the patient’s
of the professional team responsible for directly sign the care plan. We believe designee) is not an equal member of the
the preparation of the long-term and the transplant referral tracking must be part team. Each patient must be given the
patient care plans. The facility’s of the comprehensive plan of care opportunity to participate with the
professional team currently writes a condition (see § 494.90(c)), and we have interdisciplinary team. However, we
patient long-term program and a short- also proposed to strengthen this would not require them to do so in the
term care plan. However, proposed requirement in the patient assessment proposed requirements because we
§ 494.90 would require that a single (§ 494.80) and patient’s rights (§ 494.70) recognize that some patients may not
patient plan of care be developed and conditions. We are soliciting comment wish to participate in the team process.
this plan would address all of the on the appropriate role of the transplant We are proposing that the patient or
designee must sign the plan of care to current evidence-based community- blood. We did specify that one patient
assure the patient is aware of treatment accepted standards. plan of care nutritional measure, the
plans and goals regardless of whether However, we are soliciting public serum albumin (a marker of visceral
the patient has opted to participate in comments on this issue, and we will be protein stores), must be monitored on a
the care planning team process. guided by those comments in reaching monthly basis to reflect current
The patient plan of care must include a final determination on whether to standards of practice.
measurable and expected outcome require minimum threshold values for The National Institutes of Health
targets or goals for each patient based on the patient plan of care as we develop (NIH), in its Consensus Conference
the individual patient’s assessment. the final rule for new ESRD conditions Report entitled ‘‘Morbidity and
These outcome targets must allow the for coverage. Mortality of Dialysis,’’ identified
patient to achieve current evidence- nutritional status as an important
1. Development of the Patient Plan Of
based community-accepted standards. indication of the renal patient’s health
Care (Proposed § 494.90(a))
Currently, the K/DOQI clinical practice (DHHS/NIH, pp.1–33). We recognize
guidelines are the community-accepted In developing this proposed rule, we that nutrition plays an important role in
standards for individual patient care determined that there is sufficient the management of renal disease.
and we expect ESRD facilities to reflect evidence to support the inclusion of However, we have found diverse
the current standards of care for dialysis minimum set of evaluative categories in opinions about using an objective
adequacy and anemia management in the patient plan of care that have been measure as a clinical outcome measure
the patient plan of care. As additional shown by independent medical research for nutritional status. Potential clinical
evidence-based community-accepted to be important in achieving desirable outcome measures of nutritional status
standards become evident, they could patient outcomes. We are proposing (in include anthropometric measures,
be targeted in the patient plan of care as § 494.90) that the patient plan of care clinical signs of nutrient deficiency,
well. must, at a minimum, address: (1) Dose urea kinetic modeling, prognostic
We propose that allowing the patient of dialysis; (2) nutritional status; (3) nutrition indexing, and measurement of
to achieve current evidence-based anemia; (4) vascular access; (5) biochemical parameters. The NKF–K/
community-accepted standards for transplantation status; and (6) DOQI clinical practice guidelines for
dialysis adequacy and anemia means (at rehabilitation status. Each of these Nutrition of Chronic Renal Failure
§ 494.90(a)(1)), that the patient plan of elements is discussed below. (Guideline 1) state that, ‘‘there is no
care should specify a minimum single measure that provides a
delivered threshold for Kt/V of at least a. Dose of Dialysis (Proposed
comprehensive indication of protein-
1.2 (single pool) for hemodialysis § 494.90(a)(1))
energy nutritional status.’’ (NKF, pp.
patients (NKF, Guideline 4); 1.7 There is a consensus in the renal S17.) NKF–K/DOQI guideline 3 further
(weekly) for continuous ambulatory community that adequacy of dialysis in states that, ‘‘serum albumin is a valid
peritoneal dialysis (NKF, Guideline 15); terms of a Kt/V is an important clinical and clinically useful measure of protein-
2.1 (weekly) for continuous cycling performance measure and the vast energy nutritional status in maintenance
peritoneal dialysis patients (NKF, majority of dialysis facilities do use dialysis patients.’’ (NKF, pp. S20.)
Guideline 16); and 2.2 (quarterly) for minimal target levels or goal levels or We invite comments on whether any
intermittent peritoneal dialysis patients both to ensure delivery of quality care. additional specific nutritional outcome
(NKF, Guideline 16). For anemia We are proposing in § 494.90(a)(1) that measures, such as other biochemical
management (proposed § 494.90(a)(3)), the patient’s interdisciplinary team parameters of serum protein (total
the minimum specified threshold levels assist and support the hemodialysis and protein, transferrin, or prealbumin), or
in the patient plan of care are: a peritoneal dialysis patient in achieving the protein catabolic rate or protein
hemoglobin level of 11 gm/dL or and maintaining an adequate dose of equivalent of total nitrogen appearance
comparable hematocrit of at least 33 dialysis that meets evidence-based measure should be used as a patient
percent (NKF, Guideline 4). community-accepted standards as plan of care outcome measure.
There is significant correlation specified by the Secretary. We are
between achieving recommended NKF- c. Anemia (Proposed § 494.90(a)(3))
soliciting comments on the possible use
K/DOQI values for the adequacy of and appropriate minimum threshold Proposed § 494.90(a)(3) uses anemia,
dialysis and anemia management values for the adequacy of dialysis. as measured by the hematocrit (or
measures with positive outcomes in comparable hemoglobin) level, as a
mortality, hospitalization, and/or b. Nutritional Status (Proposed specified patient outcome. There is a
quality of life. Thus, the advantages of § 494.90(a)(2)) consensus in the community that the
assigning patient-level minimum targets Existing § 405.2163(d) states that the use of hemoglobin, hematocrit or both to
and thresholds is that we would dietitian, in consultation with the monitor anemia management are
establish a process when patients whose attending physician, is responsible for important clinical performance
values do not meet the criteria are assessing the nutritional and dietetic measures and the vast majority of
evaluated for possible further needs of each patient, recommending dialysis facilities do use minimal target
intervention so that they can achieve therapeutic diets, counseling on levels or goal levels or both for these
values that are associated with better prescribed diets, and monitoring measures to manage anemia in the
outcomes. It is understood that adherence and response to diets. dialysis patient. In § 494.90(a)(3) we
guidelines and standards, although Our proposed requirement on propose that the patient’s
evidence-based, are not appropriate for nutrition at § 494.90(a)(2) would require interdisciplinary team assist and
all patients in all situations. Thus these the interdisciplinary team to provide the support the hemodialysis and peritoneal
minimum thresholds serve as indicators necessary care and services to achieve dialysis patient in achieving and
for potential quality improvement and sustain an effective nutritional maintaining the expected hemoglobin/
activity. status. Effective nutritional status hematocrit level. The hemoglobin or
We are proposing that outcomes encompasses acceptable levels of hematocrit level must be measured at
specified in the patient plan of care protein, calorie, and fluid intake as well least monthly, as is the current standard
must allow the patient to achieve as acceptable levels of nutrients in the practice. We are soliciting comments on
the possible use and appropriate providing for monitoring home use of co-morbid conditions and other risk
minimum threshold values for anemia erythropoietin. We believe these factors.
management. requirements are unduly prescriptive • Support and assist the patient in
Existing § 405.2163(g) address the and may not reflect the most achieving and maintaining vascular
patient’s hematocrit or comparable appropriate items to monitor for each access patency.
hemoglobin level as a marker for the individual patient. We want to provide • Routinely monitor the hemodialysis
necessity for administering flexibility to a facility to develop its patient’s vascular access to prevent
erythropoietin at home. The assessment own criteria to monitor all patients who access failure, including routine
criteria include: (1) Preselection are using erythropoietin. monitoring of artiovenous grafts and
monitoring (lab values and blood In § 494.90(a)(3) we are proposing to fistulae for stenosis.
pressure); (2) hematocrit or comparable provide the facility with the flexibility e. Transplantation Status (Proposed
hemoglobin level less than 30 percent or to develop their own assessment and § 494.90(a)(5))
medical justification for a higher patient plan of care criteria for patients
hematocrit or comparable hemoglobin Although we are proposing to remove
for whom the use of erythropoietin
level; (3) a target hematocrit or the existing requirements for a separate
would be appropriate. In addition, we
comparable hemoglobin range for a long-term program from the conditions
are proposing in § 494.90(a)(3) that a (see § 405.2137), we are proposing in
patient receiving erythropoietin of 30 to dialysis patient’s response, including
33 percent; and (4) the patient is under § 494.90(a)(5) to retain the concept of
blood pressure and utilization of iron transplant planning. Within the plan of
the care of a physician responsible for stores, to erythropoietin must be
dialysis-related services. There are also care, the interdisciplinary team must
monitored on a routine basis. The address whether the patient is a
additional process requirements. We are patient plan of care should ensure that
eliminating some of these process transplant candidate and identify the
the patient is trained and is competent plan for obtaining a transplant. The plan
requirements and proposing that each to safely, aseptically, and effectively
patient be evaluated for anemia as and the actions necessary to make the
administer the drug; provide for transplant a reality must be addressed in
specified in the patient assessment monitoring and safe refrigerated storage
condition at § 494.80(a)(4). We are also the plan of care. Necessary actions
for home use of erythropoietin; and would include, for example, patient
proposing that any patient with a target appropriate hematocrit or
hematocrit of less than 33 percent or a transplant referral for evaluation by a
hemoglobin levels. transplant center, communication with
hemoglobin of less than 11 gm/dL must
be evaluated as a candidate for d. Vascular Access (Proposed the transplant center, and monthly
erythropoietin use. For home dialysis § 494.90(a)(4)) blood draws for antigen/antibody
patients, we are proposing that the testing. We are soliciting public
Our existing regulations do not comment on whether the ‘‘necessary
facility evaluate whether the patient can contain any specific requirements
be trained to safely, aseptically and actions’’ listed above should be a
pertaining to hemodialysis vascular requirement for dialysis facilities.
effectively administer erythropoietin,
access. We note that the hemodialysis When the patient is not suitable for
and store erythropoietin under
procedure is dependent on the transplantation referral evaluation, the
refrigeration. The patient’s response to
availability of a patent vascular access. reason for nonreferral must be written in
erythropoietin, including blood pressure
According to data from the United the patient’s assessment and notated in
levels and the patient’s utilization of
States Renal Data System access failure the patient plan of care. The reason(s)
iron stores, must be monitored on a
is the second most frequent cause of for nonreferral must be consistent with
routine basis.
Section 1881(b)(1)(C) of the Act hospitalization among ESRD patients. the criteria developed by the
specifies that the patient self- Access failure is also one of the prospective transplantation center and
administering erythropoietin must be significant contributors to hemodialysis surgeon. In cases when the patient
able to safely and effectively administer patient morbidity. The costs of vascular meets the transplantation criteria but
the drug in accordance with the access failure are also significant. In declines referral, there must be
applicable methods and standards 1999 the total Medicare ESRD program documentation in the patient plan of
established by the Secretary. Section expenditure for vascular graft failure care that the patient has made an
1861(s)(2)(O) of the Act states that was more than $97 million. Dialysis informed decision to decline renal
Medicare will pay for erythropoietin as facilities may not have complete control transplantation.
‘‘medical and other services’’ if the over the type and placement of the
access. However, it has been f. Rehabilitation Status (Proposed
patient self-administers the drug
demonstrated that efforts to improve § 494.90(a)(6))
‘‘subject to methods and standards
established by the Secretary by access patency can help to extend the Existing § 405.2163 includes
regulation for the safe and effective use life of an access. The NKF–K/DOQI rehabilitation-related activities under
of such drug. * * *’’ Section provides vascular access clinical the minimal service requirements for
405.2163(g)(2) and (3) of the existing practice guidelines that address the social services. Advances in technology
regulations specify the applicable importance of access monitoring and and pharmacology have offered the
methods as established by the Secretary. methods for improving the quality of possibility of significant improvements
In keeping with our outcome-oriented patient care in this area (NKF, pp. S137– in the well-being of dialysis patients.
focus, we are proposing to retain only S181). More efficient dialysis equipment, the
those specific evaluation criteria that are Therefore, we are proposing in development of the synthetic hormone
clinically necessary and supported by § 494.90(a)(4) to include vascular access erythropoietin and active vitamin D, for
the NKF–K/DOQI Clinical Practice as a component of the patient plan of example, represent important
Guidelines for Anemia of Chronic care with the following requirements for breakthroughs in quality-of-life areas.
Kidney Disease, 2000 Update. Also, we the interdisciplinary team: However, despite this improved
are not proposing to retain all of the • Evaluation of the hemodialysis potential for restoration, it is generally
requirements in existing patient for the appropriate vascular acknowledged that renal rehabilitation
§ 405.2137(b)(7) relating to the plan access type, taking into consideration has not yet been addressed nationally in
a consistent, integrated fashion. programs is critical to their well being, when writing and implementing the
Therefore, we are proposing to focus on ongoing treatment, and attainment of a patient plan of care.
rehabilitation outcomes through this successful adjustment to their This proposed condition does not
requirement. condition. The patient’s responsibility hold facilities accountable for
For dialysis patients, rehabilitation to participate in rehabilitation efforts is rehabilitative outcomes that are beyond
means restoring the mind and body to no less essential than her or his their control; instead, this proposed
encourage the individual to maintain as compliance with any aspect of the standard requires that interdisciplinary
full and active a life as possible. The management of her or his care. team staff use a combination of medical
Life Options Rehabilitation Advisory In this proposed rule, we are treatment, education, counseling, and
Council has defined the ideal process of separating the rehabilitation dietary regimens to maximize dialysis
rehabilitation for a dialysis patient as a requirements (proposed § 494.90(a)(6)) patients’ rehabilitation activity. Patients
coordinated program of adequate into a distinct plan of care category, and may be able to lead more active and
dialysis, education, counseling, and we are implicitly extending the productive lives if other rehabilitation
dietary regimens designed to maximize definition of rehabilitation to include interventions such as physical,
the vocational potential, functional education. We have chosen to include occupational, and recreational therapy,
status, and quality of life of dialysis rehabilitation as a specific category counseling, and education are made
patients (The Life Options because we want the interdisciplinary available to them on a regular basis.
Rehabilitation Advisory Council, p. 20). team to focus on providing patients with Joint goal-setting by informed patients
The ultimate goals of renal the opportunity and the education for and the facility staff assists this process.
rehabilitation include employment for rehabilitation. In addition, staff attitudes We believe the interdisciplinary team
those who can work, enhanced physical about rehabilitation may have a should refer patients to appropriate
fitness, increased individual control correlation to patients’ own attitudes agencies and health professionals for
over the effects of kidney disease and about their potential to regain functional additional services that the facility
dialysis, and the ability to maintain as status. cannot provide.
active a lifestyle as possible. Many renal It is not sufficient for facility staff to This proposed rule does not
professionals equate successful renal merely provide information about incorporate the use of any particular
rehabilitation with employment, in part rehabilitation to patients. Rather, the measure of rehabilitation status because
because employment can be readily essential role of rehabilitation in the we do not believe there is consensus in
measured and documented, but factors treatment and recovery process must be the renal community about a specific
other than employment must be continuously conveyed to patients and measurement at this time.
examined in a complete discussion of their families. To that end, the proposed
g. Social Services
rehabilitation or functional status of requirement for rehabilitation status
dialysis patients. requires that the interdisciplinary team We would like to specify social
Comprehensive rehabilitation efforts play a critical role in supporting the service outcomes that must be included
can make the difference between an patient and advising the patient on his in the patient plan of care. However, we
acceptable quality of life and mere or her rehabilitative efforts. Specifically, believe the social worker should
existence. The improved overall health the interdisciplinary team must provide identify social service outcomes based
and outlook of successfully rehabilitated the necessary care and services for the on the patient assessment (described at
patients may have positive cost patient to achieve and maintain an § 494.80(a)) as part of the plan of care
implications as well (Stewart, pp. 907– appropriate level of productive activity, goals for each patient.
913). Patients who are rehabilitated to including vocational, that permits the Complex emotional and social factors
the point of employment may be able to patient to resume, to the extent feasible, affect the dialysis patient, including, but
offset Medicare costs, subject to Part activities engaged in prior to kidney not limited to, changes in self-image,
411, Subpart F, of our rules, if they have failure. As part of this requirement, loss of independence, changes in
health insurance through their rehabilitation should be included in the financial security, loss of physical
employment that would cover the costs patient’s treatment prescription; the integrity, problems with sexual
of ESRD treatment in place of Medicare. patient’s involvement in rehabilitation functioning, changes in roles, and
Patients whose physical health activities should be incorporated in coping with the anxiety and discomfort
improves to the point when they can patient education materials; and facility associated with treatment. We believe
manage self-care activities may allow an patient support groups focusing on that the interdisciplinary team could
adult caregiver to re-enter the rehabilitation activities could be offered. influence many of these factors. We are
workforce. Even patients who cannot Under this condition, facility staff soliciting comment regarding the most
care for themselves, but whose outlook should encourage and educate patients effective way to address these factors
and quality of life are improved, can on the benefits of rehabilitation. The within a patient plan of care
experience positive health importance of rehabilitation as part of requirement that supports an effective
consequences that reduce costs; thus the treatment and recovery process must level of emotional and social well-being
keeping patients at home rather than in be conveyed, so patients come to for the patient.
nursing homes decreases the costs of recognize it as a benefit to themselves. Work is being done on a variety of
care as well. And costs notwithstanding, The team must reinforce activities that assessment instruments that could
the achievement of these improvements lead to successful rehabilitation. The measure the emotional and social well-
in the patient’s condition is inherently interdisciplinary team must provide being of patients. We considered the
invaluable. (The Life Options care and services to younger patients to current experiences with such
Rehabilitation Advisory Council, p. 20). enhance the possibility of a successful instruments as the Kidney Dialysis
Rehabilitation cannot be ‘‘done to’’ transition to adult life and Quality of Life instrument, the RAND
the patient. Active patient participation responsibilities. Although rehabilitation Short Form-36, and the Duke Health
in rehabilitation is key to the success of services may not be needed by pediatric Profile ((Hays, pp. 329–338); (Rand
any rehabilitation effort. Facility staff patients, there may be educational Corporation, (1997)); and (Parkerson,
must inform and educate patients that needs and developmental needs that the pp. 1056–1069), respectively). However,
their participation in rehabilitation interdisciplinary team must consider at this time we do not believe that there
is a consensus on a single instrument or therefore, the plan of care should be identified. The explanation for not
a level of psychosocial achievement for initiated as soon as possible. Clearly, we achieving the specific level of care may
dialysis patients that could be included are limiting a facility’s flexibility when include patient preferences and patient
as a specific measure for a patient plan we identify a timeframe for noncompliance.
of care requirement. development of the plan of care. Proposed § 494.90(b)(4) would specify
As specified in existing § 405.2163(c), However, we believe that a timely, that the facility must ensure every
the social worker is responsible for accurate, comprehensive plan of care is patient is seen at least monthly by a
counseling the patient and the patient’s critical for planning patient care and physician providing the ESRD care as
family, assisting the patient with the achieving desired health care outcomes. evidenced by a monthly progress note
emotional adjustment to ESRD and We believe that a maximum of 30 days that is either written in the beneficiary’s
dialysis treatment, performing crisis to complete the assessment and patient medical record by the physician or
intervention, coordinating referrals and plan of care is ample time, considering communicated from the physician’s
other community services, and the seriousness of the condition that office and placed in the beneficiary’s
arranging other benefits. Social workers necessitates the dialysis. We are medical record. We are proposing this
can, in some instances, provide some of soliciting comments on both the requirement based on a continuing
the necessary care and services for the appropriateness of prescribing a concern of beneficiaries regarding the
patient to achieve and sustain an timeframe as well as the suitability of amount of interaction between patients
effective level of emotional and social the proposed timeframe. and their physicians. We chose the time
well-being. For example, a necessary We propose at § 494.80(d) that period of at least once a month because
care and services component of social patients be reassessed as needed but no physicians have traditionally been paid
services is facility staff counseling and less frequently than annually. The for their services to renal patients on a
educating the patient and providing patient plan of care would also be monthly basis through the monthly
necessary information for the patient to reviewed at least annually since we are capitation payment. Patients who are
have a smooth transition to life on proposing that every comprehensive not stable will need to see the physician
dialysis. The social worker has an assessment must be followed by more frequently than our proposed
important role in addressing patient completion and implementation of the minimal timeframe. According to
behavior that may be challenging or plan of care. Existing § 405.2137(b)(4) preliminary information from the
disruptive. The social worker is states that care planning is conducted Dialysis Outcomes and Practice Patterns
uniquely qualified to provide monthly for unstable patients and every Study (DOPPS), better patient outcomes
counseling, anger management, and 6 months for those patients who have are associated with high levels of
emotional support services to patients become stabilized. While we have patient contact from the physician.
with ESRD. In cases in which the social retained patient plan of care monthly Almost 70 percent of the dialysis
worker is not able to provide the timeframes for unstable patients patients sampled in the United States,
necessary services for the patient to (proposed at § 494.80(d)(2)), we believe as part of the DOPPS, see their
adapt to dialysis treatment, the social that the 6-month review requirement for physician once per week or more
worker should refer patients to stable patients may be unnecessarily frequently, as reported by the nurse.
appropriate agencies and health burdensome. However, we are concerned about the
professionals for additional services. We The individualized patient plan of suggestion that as many as 5 percent of
are soliciting comments regarding the care is not static and will require the dialysis patients may see their
potential for an outcome-based adjustments as the needs of the patient physician less often than once a month.
requirement for social services in the change, particularly if the patient is not While we are proposing a minimum
patient plan of care. stable. We propose at § 494.90(b)(3) that monthly physician visit (without
the interdisciplinary team must adjust specifying any duration for the visit
2. Implementation of the Patient Plan of the patient plan of care to achieve and itself), we do not want to discourage
Care (Proposed § 494.90(b)) sustain the specified patient outcomes more frequent visits. On November 7,
The patient plan of care stems from goals. New strategies may need to be 2003, we published a final rule (68 FR
the patient comprehensive assessment implemented as assessment, response, 63196, 63216) regarding the revisions to
that identifies patient care needs. and patient preference information the payment policies under the
Proposed § 494.90(b)(1) would require requires. If the targeted plan of care goal physician fee schedule for calendar year
that the patient’s plan of care be is achievable but is not being attained, 2004. This rule aligns payment
completed by the interdisciplinary the facility must implement an incentives with the frequency of the
team, signed by the patient or the improvement plan to reach the goal. physician’s evaluation of the dialysis
patient’s designee, and implementation We recognize that patient outcomes patient. In addition, the rule assigned
must begin within 10 calendar days are determined in part by factors outside new G codes that associate a higher
after an assessment is completed. As of the dialysis facility’s control, such as payment to a physician who provides
stated in the patient assessment demographics, the systemic effects of more visits within each month to an
condition, the facility interdisciplinary the underlying renal disease, and ESRD patient. Physicians should see
team has 20 days from the initiation of patient preferences and compliance. patients and monitor their care as often
dialysis treatment to complete the Further, we recognize that health care as is medically necessary to ensure that
comprehensive assessment. After the delivery is dynamic and that all patients they are progressing towards the
assessment has been completed, the may not be achieving for example, the specified outcomes.
interdisciplinary team has 10 days to expected delivered dose of dialysis at We believe it is important for
develop the patient’s plan of care. This any specific point in time. If the patient physicians to see in-center hemodialysis
gives the dialysis facility a maximum of is unable to achieve the desired health patients periodically while they are
30 days to complete the comprehensive outcomes, the plan of care should be undergoing dialysis in order to monitor
assessment and the patient plan of care. adjusted to reflect the patient’s the quality of care they are receiving
We selected 10 days for completion of condition along with an explanation, and to address the patient’s particular
the patient care plan because the plan and any opportunities for improvement clinical concerns and needs while in the
directs the patient’s treatment, and in the patient’s health should be treatment environment. We believe
periodic in-center monitoring by the responsibility for their own health by a mechanism to inform the physician of
patient’s hemodialysis physician is an complying with the treatment plan and the results; (6) training the patient to
accepted medical practice and would participating actively in rehabilitation identify signs of hypotension and
not impose any additional burden on activities. Educating and training hypertension; and (7) decreasing or
dialysis facilities. We are soliciting patients and their families is key to a discontinuing erythropoietin usage if
comments regarding whether physicians successful transition to a life with hypertension is uncontrolled.
should be required to see their in-center dialysis. Existing § 405.2139 requires facility to
patients periodically while those However, not all elements of the maintain ‘‘complete medical records’’
patients are being dialyzed in the existing § 405.2137 will be retained in on all patients, including its home
dialysis facility. Such in-center visits proposed § 494.90. In accordance with patients. Section 405.2139(d) contains
would not be in addition to the monthly our approach to consolidate all similar requirements regarding medical records
requirement proposed in § 494.90(b)(4). standards, we propose to move the information generated by self-dialysis
requirements in existing patients and entries of medical records
3. Transplantation Referral Tracking
§ 405.2137(b)(5) regarding the transfer of information by trained self-dialysis
(Proposed § 494.90(c))
the patient’s medical records to the patients, or ‘‘trained assistants,’’
We are proposing at § 494.90(c) that proposed medical records condition for countersigned by facility staff.
the interdisciplinary team track the coverage (§ 494.170), and move the Existing §§ 405.2163(e)(1) through (6)
results of each kidney transplant center requirements in existing list a facility’s home dialysis support
referral and monitor the status of any § 405.2137(b)(6) regarding the services including: (1) Surveillance of
facility patients who are on the monitoring of home dialysis patients to the patient’s home, including periodic
transplant wait list. The routine the proposed Care at Home condition visits; (2) consultation for the patient
exchange of information between the for coverage (§ 494.100). We believe that with a qualified social worker and
dialysis facility and the transplant this reclassification will improve the qualified dietitian; (3) a record keeping
center is important so that both facilities proposed regulation’s organization. system that assures continuity of care;
know who is active on the transplant
D. Condition: Care at Home (Proposed (4) installation and maintenance of
wait list, who is temporarily or
§ 494.100) equipment; (5) testing and appropriate
permanently inactive, and who is under
treatment of the water; and (6) ordering
evaluation. In addition, there may be a [If you choose to comment on issues in supplies on an ongoing basis.
need to coordinate histocompatibility this section please include the caption
testing, which must be completed on a Existing § 405.2163(g)(1) through (4)
‘‘Care at Home’’ at the beginning of your
monthly basis. We invite comment on requires the facility or physician
comments.]
the coordination of the transplant responsible to make a comprehensive
process and the method and frequency 1. Dialysis of the ESRD Patient in the patient assessment that includes the
of communication with the Home Setting following: (1) Preselection monitoring,
transplantation center. Home dialysis has been shown to including the patient’s hematocrit (or
have a positive effect on a patient’s hemoglobin), serum iron, transferrin
4. Patient Education and Training saturation, serum ferritin, and blood
quality of life. Home dialysis affords the
(Proposed § 494.90(d)) pressure; (2) conditions the patient must
patient control over the scheduling and
The existing regulations do not setting; it can be done in comfortable, meet, including a hematocrit (or
specifically address patient education familiar surroundings; and it is less comparable hemoglobin) hematocrit
and training for in-center patients. disruptive to family life and level of 30 percent (for patients
However, in § 494.90(d), we are employment than in-center dialysis. initiating erythropoietin treatment), or a
proposing to stipulate that the patient The existing requirements for home level of 30 to 33 percent (for patients
plan of care must include, as applicable, dialysis are located in four sections: (1) already under the care of a dialysis
education and training for patients and Definitions (§ 405.2102); (2) patient care facility or physician); (3) a requirement
families in all relevant aspects of the plan (§ 405.2137(b)); (3) medical records that patients or caregivers must be
dialysis experience, dialysis (§ 405.2139); and (4) minimal service trained to inject erythropoietin, read
management, quality of life, requirements (§ 405.2163(e) and (g)). and understand drug labeling, and
rehabilitation, and education regarding Existing § 405.2102 defines home observe aseptic techniques; and (4) the
renal transplantation. When kidneys dialysis as dialysis performed by an assessment must find that
fail, the resulting physical changes appropriately trained patient at home. erythropoietin can be refrigerated in the
stimulate a chain of psychological and Existing § 405.2137(b) states that patient’s residence and potential risks
physiological events that alter the lives home dialysis patients will receive a and hazards related to the drug and
of the affected individuals and their written care plan with the same criteria syringes are understood by the patient.
families. The education of patients and that are specified for in-center patients. In § 494.100, we proposed
their families goes beyond providing the Section 405.2137(b)(6) requires the requirements that are only applicable to
necessary information for patients to ESRD facility to conduct periodic home dialysis. Since not every facility
make an informed choice regarding monitoring of the patient’s home chooses to provide home dialysis, this
treatment modality. Because the life adaptation, including visits to the home condition would apply only to a facility
changes associated with beginning by ‘‘qualified facility personnel’’ as that provides these services.
dialysis are so profound, patients and appropriate. Section 405.2137(b)(7) We propose in the opening paragraph
their families need to be educated and contains patient care plan requirements of § 494.100 to retain the implicit
trained about strategies for successful that apply to home dialysis patients requirement in existing § 405.2163 that
adaptation to dialysis, optimizing who use erythropoietin, including: (1) services to home patients are at least
functional status, employment options, Monitoring diet and fluid intake; (2) equivalent to those provided to in-
and many other issues. Patients and medication usage; (3) hematocrit and center patients. Home dialysis patients
their families must learn about the iron stores; (4) reevaluations of the are patients of the ESRD facility; and
disease and the possibilities of life dialysis prescription; (5) a method for therefore, they are entitled to the same
beyond it and then assume physician follow-up on blood tests and rights, services, and efforts to achieve
expected patient outcomes as any other it does not specify the content of that (2) retrieve and review self-monitoring
patient of the facility. training program. Therefore, we are data from patients or caregivers at least
We are proposing to address home proposing the following subject areas for every 2 months; and (3) maintain this
dialysis training in § 494.100(a). In our home dialysis training programs in information in the patient’s medical
deliberations regarding home dialysis §§ 494.100(a)(3)(i) through (a)(3)(x). record. The goal of the proposed
training requirements, we took into These types of programs would, at a standards is that facilities effectively
account the considerable lifestyle minimum, be required to provide coordinate the care of all patients,
changes associated with initiating home training in the following: including home dialysis patients, to
dialysis and the unique needs of • The nature and management of achieve the desired outcomes. As
patients and caregivers engaged in home ESRD. previously stated, we recognize that
dialysis. Patients and their caregivers • The full range of techniques home patients do not see facility staff as
need to be trained and educated about associated with the applicable type of frequently as in-facility patients, so the
strategies for successfully adapting to home dialysis, including effective use of purpose of this proposed requirement is
dialysis at home, ways to optimize dialysis supplies and equipment in to ensure that the facility’s
functional status, proper self-dialysis achieving the physician’s prescription interdisciplinary team periodically
procedures, and many other issues. of Kt/V or URR, and effective monitors the care of home dialysis
Therefore, the processes of educating erythropoietin administration (if patients’ plans of care.
and training patients and their prescribed) to achieve a hematocrit level Existing § 405.2139(d) requires
caregivers are crucial to a successful of at least 33 percent or a hemoglobin dialysis facilities to collect medical
transition to a life with dialysis and to level of 11 gm/dl. information generated by self-dialysis
achieving good patient care outcomes. • Nutritional care planning. patients, but it does not specify the
In the opening paragraph of • Achieving and maintaining frequency of the data collection. By
§ 494.100(a), we are proposing that emotional and social well-being. proposing at § 494.100(b)(2) that the
before the initiation of home dialysis, • How to detect, report, and manage home patient’s facility collect and
when the caregiver changes, or when potential complications. review information at least every 2
the home modality changes, that the • Availability of support services and months, we ensure the interdisciplinary
facility’s interdisciplinary team is how to access and use available support team can determine if the patient is
responsible for providing self-dialysis services. having problems with any aspect of the
training to the home patient, the • How to self-monitor health status dialysis therapy at regular intervals. We
patient’s designated caregiver, or both. and record and report health status would recommend that the facility
Self-dialysis (as defined in existing information. collect data that will enable it to
§ 405.2102(b)(2)(ii) and proposed • How to handle medical and non- determine if home patients are adhering
§ 494.10) means dialysis performed with medical emergencies. to the plan of care and achieving
little or no professional assistance by an • Infection control precautions. expected outcomes. Based on the data
ESRD patient who has completed an • Proper waste storage and disposal received, the facility staff can determine
appropriate course of training. Home procedures. if the patient or caregiver needs to be
dialysis training may be only be While we recognize that specifying retrained or, in some cases, determine
provided by a dialysis facility certified the topics for a training program appears that the patient is no longer a suitable
to provide home dialysis services. to be inconsistent with our goal of candidate for self-care dialysis. As with
Durable medical equipment (DME) reducing process-oriented requirements, in-facility patients, the goal of collecting
companies cannot provide home we believe it is critical and necessary data on home dialysis patients is to
dialysis training. We are proposing in that the items listed above be required, ensure that they are achieving the
§ 494.100(a)(1) to modify the existing so that patients and caregivers are fully expected outcomes.
requirement at § 405.2102(d)(3) that self- informed regarding the health and safety We propose to retain many of the
dialysis training must be conducted by procedures that must be followed and existing support services requirements
a registered nurse with 18 months of precautions that must be taken when at § 405.2163(e) in proposed
clinical experience and at least 3 providing dialysis at home. § 494.100(c). We have always taken the
months of specialized experience in Home patients are not seen 3 times a view that the law and the regulations
training dialysis patients in self-care. week by facility staff like in-center require that the facility provide all of
We are proposing to modify these patients; and therefore, the quality and these support services, regardless of
requirements to state that self-care content of home training given to whether the dialysis supplies are
training must be conducted by a patients and their caregivers is an provided by the dialysis facility or a
registered nurse who meets the extension of the care and monitoring durable medical equipment (DME)
personnel qualifications specified in that would normally be provided in the company, to the extent that they are
§ 494.140(b)(2) (that is, 12 months dialysis facility. In addition, the facility medically necessary for a beneficiary’s
clinical experience and an additional 3 is responsible for ensuring that home care. In addition to meeting other
months of clinical experience in the dialysis patients are achieving the requirements, the proposed Care at
specific modality for which the desired outcomes, and this training will Home condition is intended to assure
registered nurse will provide training). inform home care patients or their that home dialysis patients, including
As previously stated, home dialysis caregivers or both of the plan of care those residing in nursing facilities (NFs)
training is crucial to achieving desired that must be followed (see proposed or skilled nursing facilities (SNFs), are
patient outcomes; and therefore, we § 494.90) to achieve the expected receiving care that is comparable to the
believe the initial training a patient results. care provided to in-facility patients.
receives must be provided by an We propose in §§ 494.100(b)(1) Thus, the support services provided to
experienced health care professional. through (3) that the dialysis facility: (1) home dialysis patients should parallel
Existing § 405.2102 requires that a Record who received the training the treatment provided to patients in a
facility provide a training program for described in § 494.100(a)(3) and indicate dialysis facility.
self-dialysis and home dialysis patients, that the patient or caregiver We are proposing in § 494.100(c)(1)(i)
if it chooses to provide this service, but demonstrated adequate comprehension; to retain the existing requirements at
§ 405.2137(b)(6) regarding periodic be furnished to achieve and maintain continuity of care. The medical record
surveillance of the patient’s home the expected outcomes of care. is used for diagnosing, treating, and
adaptation, including provisions for We are proposing in § 494.100(c)(1)(v) caring for the patient. We believe this
visits to the home by facility personnel. to retain and expand the existing requirement is vital to the effective
In addition, we are proposing in requirement at § 405.2163(e)(5) to coordination of services provided to
§§ 494.100(c)(1)(ii) through (iv) to retain monitor the quality of the water used by home dialysis patients because the
existing requirements in §§ 405.2137(b) home hemodialysis patients. We are medical record indicates what care has
and 405.2163(e) to: (1) Coordinate the specifically including onsite evaluation actually been provided and what
home patient’s care by a member of the of the water system. Since we have outcomes have been achieved. The
facility interdisciplinary team; (2) incorporated by reference the AAMI medical record documents the services
develop and periodically review the standards regarding water quality at provided by the interdisciplinary team
patient’s plan of care (see § 494.90) to § 494.40(a)(1)(i) and (ii), we are also members and provides an accurate
address the patient’s needs and achieve proposing that a facility adhere to the picture of the patient’s progress in
expected outcomes of care; and (3) applicable AAMI guidelines in achieving care goals. Further, it
consult with the members of the determining whether the home dialysis provides the data for evaluation and
interdisciplinary team as needed. patient’s water system meets acceptable documentation of the quality and
Existing § 405.2163(e)(2) requires standards. If water supplies are appropriateness of care delivered.
consultation with a qualified social biologically or chemically Adequate record keeping is vital to
worker and dietitian. We are proposing contaminated, contaminants may be ensure continuity of care and to ensure
in § 494.100(c)(1)(iv) to strengthen this passed to the patient during the dialysis that the home dialysis patient is
requirement by including any member session, leading to infection or other receiving quality care.
of the patient’s interdisciplinary team adverse consequences. Therefore, a In addition, the patient’s supplier is
because some home dialysis patients dialysis facility must monitor the often not part of the facility staff; and
may experience problems or have needs quality of water used in treatments, as therefore, it may be difficult to ascertain
well as monitor the equipment used in the services they provide the home
that require consultation with several
water treatment. Because water is one of patient. In some instances, the services
members of the interdisciplinary team,
the most important aspects of health of home patients are not effectively
and we do not want to limit their access
and safety, we are proposing in coordinated. As a result, the facility staff
to appropriate care. In addition, we
§ 494.100(c)(l)(v) to require that the is often not able to provide
recognize that patients who are new to
facility conduct onsite evaluation of the comprehensive care to home patients,
dialysis therapy need a period to adjust
patient’s water system if the AAMI- and the quality of care suffers. In an
and adapt to their treatment. Initially
specified analysis of the water quality effort to encourage facilities to
patients may experience anxiety while
indicates contamination or if the home coordinate services effectively,
learning self-care skills, how to perform
patient demonstrates clinical symptoms § 414.330(a)(2)(ii)(C) would require that
the dialysis treatment, how to modify associated with water contamination. the patient’s supplier report to the
their diet, and how to change their The dialysis facility must ensure that facility, every 30 days, all services and
behavior. any problems with the water treatment items furnished to the beneficiary so
We also believe the interdisciplinary system are corrected. If the problem that the information can be documented
team must be responsible for the cannot be corrected immediately, the in the patient’s medical record. One of
development and periodic review of the dialysis facility must arrange for backup our primary goals is to have the care of
patient’s individualized, comprehensive dialysis until the water quality at the home patients parallel the care of in-
care plan based on the comprehensive patient’s home can be adequately facility patients, and this can only be
assessment (see § 494.80) that specifies restored. accomplished if all information on
the services necessary to address the We are proposing in patient care is reported to the facility.
patient’s needs and includes measurable § 494.100(c)(1)(vi) to retain the existing We selected 30 days because monthly
and expected outcomes. We are requirements of section 1881(b)(9) of the reporting and billing is commonly used
proposing in § 494.100(c)(1)(iii) to Act and §§ 405.2163(e)(4) and (e)(6) of by dialysis facilities and by suppliers
expand the existing requirements by the regulations that require the facility and we believe that this will not
including a statement that the patient’s to install and maintain medically produce additional burden. All patient
comprehensive plan of care will be necessary home dialysis supplies and data are necessary to effectively evaluate
developed and reviewed by the equipment prescribed by the attending the patient’s dialysis prescription and
interdisciplinary team to address the physician. In addition, for those home make changes to the patient plan of
patient’s needs and to achieve the patients not receiving equipment and care. A less frequent reporting
expected outcomes of care. To that end supplies from a DME company the timeframe would compromise efforts to
we are encouraging and recommending dialysis facility must also purchase and correct deficiencies in the patient’s plan
that dialysis facilities adopt the same deliver the necessary home dialysis of care (for example, adjustments to the
clinical performance measures for home supplies and equipment. dialysis prescription) by the patient’s
patients as those that are used for in- Furthermore, we propose in physician and other necessary
center patients. As previously stated in § 494.100(c)(1)(vii) to require the facility corrective actions by the patient’s
the discussion of the patient plan of care to plan for and arrange for emergency interdisciplinary team. We welcome
condition for coverage (§ 494.90), the backup dialysis services. This plan comments on the proposed timeframe
goal is to obtain input from each should address how emergency for the patient’s supplier to report to the
member of the interdisciplinary team as situations will be dealt with, and should facility.
well as from the home patient so as to hemodialysis be required, include a
develop a comprehensive plan of care plan for obtaining this service. 2. Dialysis of ESRD Patients in Nursing
that indicates the services necessary to We are proposing in § 494.100(c)(2) to Facilities and Skilled Nursing Facilities
address the home patient’s needs. The retain the requirement at The existing regulations allow
home dialysis patient’s plan of care § 405.2163(e)(3) that a facility maintain hemodialysis to be provided within NFs
should stipulate the services that are to a record keeping system that promotes and SNFs when there is a certified
hemodialysis facility on-site or regulatory expectations for the provision care of an independent home dialysis
adjoining the NF or SNF and when the of dialysis in the NF or SNF. patient, and given their frailty, these
patient is a home dialysis patient who Dialyzing patients in NFs or SNFs patients may be more vulnerable than
has been appropriately trained. In a without a certified ESRD facility within an independent home dialysis patient.
March 19, 2004 letter to State survey or adjoining the NF or SNF may present Because of this, we have significant
agency directors entitled, ‘‘Clarification both opportunities and risks. Dialysis safety concerns about encouraging home
of Certification Requirements and patients who remain in the NF or SNF dialysis, provided by multiple
Coordination of Care for Residents of are less likely to miss medication caregivers, who may not have any
Long-term (LTC) Facilities Who Receive administration, treatment regimens,
dialysis experience, in this setting.
End Stage Renal Disease (ESRD) meals or planned activities during time
that would otherwise be spent in Home dialysis patients may choose to
Services’’ (Reference: S&C–04–24), we
waiting and transportation to and from obtain their dialysis supplies and
clarified certification requirements and
a dialysis facility. We know that some equipment from either the dialysis
coordination of care expectations for
patients would prefer to stay in their facility that provides the home training
residents of LTCs who receive dialysis.
residence and dialyze while others and support services (Method I
On July 8, 2004, we sent State survey
would prefer to be transported to a payment) or from a DME company
agency directors and addendum to the
certified dialysis facility for care. We (Method II payment). The dialysis
March 19, 2004 letter that included as believe that both choices should be
an attachment follow-up questions and facility may have more patient contact
available for NF or SNF residents, and and be more able to determine that
answers regarding the scope of the we believe that both choices should
guidance and the responsibilities of the necessary supplies are provided at the
provide patient protections for health right time and in the right amounts to
providers (Reference: S&C–04–37). In and safety. In addition, we believe that
this proposed rule, we are soliciting meet the needs of home patients due to
patients receiving dialysis in a NF or the enhanced patient contact. If
comments on a wide range of issues SNF should not be deprived of essential
affecting the population of patients who hemodialysis were provided to NF or
services that they would normally
are nursing home residents and who SNF residents within the home dialysis
receive in an outpatient dialysis facility.
desire to be dialyzed in the nursing Finally, we need to assure that, in model, these patients would continue to
home. We have received inquiries as to providing hemodialysis treatments in a be able to choose between Method I and
whether an institutionalized setting NF or SNF, the care of other residents Method II.
such as a long-term care facility may be in the NF or SNF not requiring dialysis In order to address the issue of home
considered to be a beneficiary’s ‘‘home’’ is not negatively impacted. We are dialysis in the NF or SNF, we believe
for self-dialysis purposes. In the past we soliciting comments on whether the there needs to be clarity about the
have provided guidance in response to current home dialysis regulations need various roles and responsibilities of the
these inquiries. Home dialysis is to be modified to protect this vulnerable certified ESRD facility providing
currently only an option for NF or SNF population, and if so, in what ways and dialysis care and the responsibilities of
patients when certain conditions are under what particular set of the NF or SNF when there is no certified
satisfied: (1) The NF or SNF must be circumstances. ESRD facility onsite or adjoining the NF
considered to be the patient’s home (for In the current ESRD regulations, the
or SNF. While we have addressed many
short NF or SNF stays, such as home dialysis training requirement
of these concerns relative to the existing
rehabilitation or brief recovery time presents a significant barrier in
providing home dialysis to NF or SNF regulations through guidance to the
admissions, the nursing home would
residents as the patient may be State survey agency directors, the
not be considered the patient’s home
untrainable and may not have a ready important issues that we would have to
since the expectation is that the patient
caregiver who could be co-trained to address through new rulemaking and
would soon be discharged and return to
assist the resident in performing the issues on which we request
their own home); (2) the patient (and his
or her family member or caregiver) must dialysis. The patient’s role in home comment are discussed below.
complete the home dialysis training; (3) dialysis is defined at § 405.2102 under a. Delineation of Responsibility
all home dialysis patients must have the definitions section of the
their own dialysis machine, equipment, requirements. The regulations require We believe the home hemodialysis
and supplies; and (4) home dialysis the patient to take part in the training. services provided in a NF or SNF
patients must receive their support We have received correspondence should be provided under the direction
services from a certified dialysis facility. requesting that the home-dialysis of a certified dialysis facility that is
training requirement be waived for NF responsible for the dialysis care
Currently the NF or SNF patient who or SNF residents. It has been our long-
requires hemodialysis may be provided to the ESRD patients, for
standing policy to encourage home
transported to a certified outpatient assuring that the NF or SNF is capable
dialysis. We are also aware of the
hemodialysis facility or may receive of providing appropriate pre- and post-
current limitations relative to severely
treatment from a certified hemodialysis debilitated patients who are ineligible dialysis care, and for assuring that there
facility available within or adjoining the for home dialysis based on the training is coordination of care between the two
NF or SNF. We recognize the hardship requirement. Given the relative acuity of entities, that is, the nursing home and
placed on long-term care patients who nursing home patients, there are safety the ESRD facility. In order to assure that
must be transported to offsite dialysis concerns associated with allowing roles and responsibilities are clearly
facilities 3 times per week. Since there patients in nursing homes to be home delineated prior to the initiation of care,
is potential growth for home dialysis in dialysis patients. These patients may be we believe there should be a written
NFs and SNFs because of changing less able to voice symptoms/problems agreement (specifying responsibilities
demographics in both the ESRD then the typical ESRD home patient. In and the coordination of care) between
population and the general population, addition, the dialysis care of a patient all parties providing the care, including
it may be appropriate for us to provide who requires nursing home services the NF or SNF (and the DME supplier,
further guidance regarding the may be more complex than the dialysis if applicable).
b. Applicable ESRD Conditions for situation when the NF or SNF is periodic monitoring of the institutional
Coverage considered the patient’s residence. residence to assure that appropriate care
is being provided; (2) provide
Consideration must be given as to d. Training
monitoring of supplies and equipment;
whether home dialysis care provided in We believe that training provided by (3) maintain medical records in both the
a NF or SNF must comply with all of the the certified ESRD facility should be NF or SNF and at the certified ESRD
proposed conditions for coverage, specified and the ESRD facility should facility; and (4) assure that patient rights
except § 494.120, that governs special be responsible for providing training to are protected as they would be in a
purpose dialysis facilities and the NF or SNF staff and to all caregivers dialysis facility, including access to a
specification at § 494.180(d) that who will be working with the ESRD formal grievance process by the patient
services must be provided on or patients. These caregivers could or the patient’s guardian or advocate.
contiguous with the premises. possibly include the nursing and We want to ensure that the health and
c. Nursing Coverage support staff of the residential safety of NF or SNF hemodialysis
institution, dialysis facility nurses and patients is protected and so we are
The existing regulations patient care technicians, and the soliciting comment on the provision of
(§ 405.2162(b)) require that a licensed caretaker that may be provided by the hemodialysis in the NF or SNF on the
health professional (for example, DME supplier, if available and the issues discussed above. Specifically, we
physician, registered nurse, or licensed patient is a Method II home dialysis solicit comment on what competency
practical nurse) experienced in patient. We note that Medicare does not requirements and experience/
rendering ESRD care is on duty to provide additional reimbursement for
qualifications should be proposed for
oversee ESRD patient care whenever caregiver services within the current
the caregiver (who is not a patient’s
patients are being dialyzed. This payment system. We believe that
family member) and for the registered
proposed rule would require (proposed caregiver-training requirements that are
nurse, what restrictions should be
§ 494.180(b)(2)) that a registered nurse similar to the training specifications for
placed on the caregiver or the registered
be on the premises whenever in-center home dialysis patients may be
nurse or both, and whether caregiver to
patients are being treated. We believe appropriate.
patient ratio limits should be proposed.
that there would be a comparable risk to e. Monitoring We are interested in any suggestions
patient health and safety if a licensed regarding this issue to provide for the
nurse was not on the premises of the NF If we were to propose requirements on
this topic, we believe that the certified specific needs of this vulnerable
or SNF and available during multiple population, and on how we can make
simultaneous home NF or SNF dialysis ESRD facility should be responsible for
monitoring the care of the ESRD patient these requirements more flexible to
treatments. Consideration must be given meet the needs of the providers, while
as to whether this registered nurse could in the NF or SNF. We also believe that
the dialysis facility should assure that providing appropriate patient
be a NF or SNF registered nurse trained protections.
by the ESRD facility, or a registered trained caregivers be present in the
nurse provided by the ESRD facility to room with the patient at all times while E. Condition: Quality Assessment and
be available during NF or SNF the hemodialysis is being provided. Performance Improvement (Proposed
hemodialysis treatments. This ensures that a knowledgeable § 494.110)
individual is available to assist the
If the NF or SNF were allowed to patient if any problems arise. [If you choose to comment on issues in
provide this registered nurse to be We believe that the ESRD facility this section please include the caption
available during hemodialysis should—(1) periodically assess the ‘‘QAPI’’ at the beginning of your
treatments then the implications for care ability of the staff (NF or SNF staff and comment.]
(requiring registered nurse attention) caregiver) responsible for care of the An integral part of our effort to move
provided to other NF or SNF residents ESRD patient to assure that they are toward a patient outcome-based system
must be considered. We are considering competent in their tasks; (2) retrieve and is the facility level quality assessment
whether a limitation of the NF or SNF review complete data, including and performance improvement (QAPI)
registered nurse’s duties is necessary, so laboratory data, clinical data, outcome program. We propose to require that a
that the nurse is available to meet data, and interdisciplinary team notes to dialysis facility create its own tailored
dialysis needs while another nurse assure that adequate care is being program for quality improvement based
tends to the NF or SNF residents (for provided; (3) monitor the care of the on the framework provided in this
example, such as the absence of direct patients, using appropriate clinical condition. Existing §§ 405.2112(c) and
NF or SNF resident care responsibilities standards; and (4) work with the NF or 405.2113(a) address quality standards
and allowance of only administrative SNF staff to monitor whether dialysis for patient care in the context of the
duties). When considering whether the treatments being provided in the ESRD network organization’s role.
NF or SNF registered nurse may be the nursing home negatively impact the care Although § 405.2134 requires each
licensed individual responsible for of other NF or SNF residents and correct dialysis facility to participate in
overseeing resident care when residents such impact as appropriate. network activities and to pursue
are being dialyzed, the provision of We believe that the dialysis facility network goals, there is currently no
training by the ESRD facility for this should ensure that care being provided clear Federal requirement for an
individual also must be addressed. to patients receiving dialysis in a NF or ongoing facility-specific, patient-
While the registered nurse would SNF is comparable to the care provided centered continuous quality
oversee the dialysis, a trained caregiver to facility patients. Thus, the support improvement program. The focus on
would administer the dialysis treatment. services provided to NF or SNF outcomes in this proposed rule is a
In a typical home dialysis patient residents should parallel the treatment result of the fundamental shift in
situation, the ratio of patient to provided to patients in a dialysis approach to performance expectations
caregiver is one-to-one. We solicit facility. Therefore, we believe that the within the health care industry and
comments on whether we should dialysis facility providing dialysis in a efforts within the renal community to
address patient to caregiver ratios in a NF or SNF must also: (1) Provide define and examine outcomes.
In 2000, the Office of the Inspector prevent medical errors and improve the performance and a patient-centered
General (OIG) of the Department of quality of care. This Administration is focus. The evaluation includes
Health and Human Services (DHHS) committed to working with other public measuring actual performance, as well
conducted an extensive review to and private stakeholders to develop as the impact of the performance on
ascertain the effectiveness of our means for improving and expanding the patient outcomes and satisfaction. The
monitoring of the ESRD program. Their use of information technologies (such as evaluation answers the question: ‘‘Did
subsequent report was entitled bar coding and computerized physician that process, treatment or procedure
‘‘External Quality Review of Dialysis order entry systems) in health care produce the targeted outcomes?’’ The
Facilities: A Call for Greater settings. approach gives the facility the ability to
Accountability’’ (DHHS/OIG, June Proposed § 494.110 would require analyze interdependent processes of
2000). The purpose of this review was that a facility develop, implement, care and adjust them to optimize the
to ‘‘assess external mechanisms HCFA maintain, and evaluate an effective, system for providing care.
relies upon to monitor the quality of data-driven, quality assessment and
performance improvement program that 1. Program Scope (§ 494.110(a))
care provided by dialysis facilities to
Medicare beneficiaries with ESRD.’’ reflects the complexity of the dialysis We are proposing in § 494.110(a) to
This OIG report provides a thorough facility’s patient population and its require that the dialysis facility’s QAPI
review of the external quality oversight processes of care. The dialysis facility program address at least the following
of dialysis facilities in the United States must take actions that result in areas: (1) Adequacy of dialysis; (2)
and the roles played by CMS, the State performance improvements in the nutritional status; (3) anemia
survey agencies, and the ESRD quality of patient care. We believe that management; (4) vascular access; (5)
networks. The OIG recommended that dialysis facilities need to have a medical injuries and medical errors
dialysis facilities be required to conduct continuous quality improvement system identification; (6) hemodialyzer reuse
their own quality improvement in place to continually assess and program (if applicable); and (7) patient
programs. The OIG also recommended improve health care delivery. The satisfaction and grievances. We believe
that facilities be required to establish facility’s quality improvement program that these areas are reflective of: (1) the
internal systems for identifying and should monitor the systems and degree to which the facility achieves
analyzing the causes of medical injuries processes of care that are used to desirable patient outcomes; the extent of
and medical errors. Another achieve the targeted patient outcomes. patient safety within the facility; and (2)
This approach calls for facilities to the level of satisfaction attained as the
recommendation was to require
systematically collect and analyze patient experiences the continuum of
facilities to monitor patient satisfaction.
clinical data about the components of care.
The Institute of Medicine’s (IOM) 1991 Adequacy of dialysis has become an
report, ‘‘Report on Kidney Failure and their care processes. The majority of
facilities already collect clinical important clinical performance measure
the Federal Government’’ suggests that for benchmarking the quality of dialysis
relating the conditions for coverage to performance measures as described in
the 2002 OIG report, which describes care. We believe that it is appropriate
patient outcomes would assist the and necessary to consider using
quality assurance efforts of the ESRD the quality improvement programs of
large dialysis corporations (DHHS/OIG, consensus performance measures in our
program (IOM, 1991). health and safety standards for facilities.
January 2002). The 5 largest dialysis
The 2001 IOM report, ‘‘Crossing the corporations (representing 67 percent of The NKF–K/DOQI guidelines for
Quality Chasm: A New Health System the total number of dialysis facilities) hemodialysis adequacy (guideline 4)
for the 21st Century’’ addresses the need routinely collect data on at least 14 provide minimal adequacy of
to narrow the quality chasm between clinical performance measures; and hemodialysis levels of Kt/V of 1.2 and
the potential benefits of medical science therefore, requiring collection of those URR of 65, but do not suggest optimal
and technology and the actual level of clinical performance data would not dialysis target levels, based on their
health care provided in the United impose an additional data collection conclusion, after a literature review, that
States (IOM, 2001). The report offers a burden on most dialysis facilities. These there is not sufficient data to make that
strategy and action plan for building a types of data can be used to assess determination (NKF, 2000).
stronger health system over the coming facility care processes and to identify The Hemodialysis Study sponsored
decade. The report presents multiple opportunities for improvement. Once by the National Institutes of Health
challenges to health care leaders and the opportunity has been identified, the began in 1995 and was a comprehensive
points out that all organizations can facility should develop and implement randomized clinical trial of dose and
improve their performance by an intervention strategy that focuses on flux interventions to identify
incorporating care process and outcome the processes that need improvement, improvements in therapy that will
measures into their daily work. In and then evaluate whether the reduce hemodialysis mortality. The
addition, many renal groups (including improvement strategy achieved the study entitled ‘‘Effect of Dialysis Dose
the RPA, the American Nephrology desired results. The facility should and Membrane Flux in Maintenance
Nurses Association, the NKF, and the reexamine goals that have been Hemodialysis,’’ confirmed that the
American Association of Kidney achieved and, if applicable, undertake minimum dosage of thrice weekly
Patients) have developed similar new interventions to further increase hemodialysis as stated in the NKF–K/
positions. We believe that the quality the quality of care processes, outcomes, DOQI Guideline 4 (that is, Kt/V of 1.2
improvement activities in this proposed and patient satisfaction. The facility and URR of 65) is adequate and that, in
rule and the data systems of the future must continue to track its performance general, a high dosage and special high-
will provide an opportunity to focus to assure that improvements in patient flux filters provide no added benefit in
more closely on patient outcomes. We outcomes and patient satisfaction are terms of survival, rate of hospitalization,
believe that it is critically important that sustained. This is what is meant by the and albumin levels to patients
dialysis facilities examine the adequacy cycle of continuous quality (Eknoyan, pp. 2010–2019). The
of their information technology and improvement. Hemodialysis Study also found
identify opportunities to improve and This QAPI approach demands an statistically nonsignificant data
expand the use of such technologies to evaluation of organizational suggesting that higher dialysis dosage
appeared to reduce mortality and overall quality of life. The nutritional risk of hospitalization is increased with
hospitalization for women in those who status of the patient may be affected by hematocrit levels less than 30 percent.
had been receiving hemodialysis longer medical symptoms, physiological The 2001 ESRD Clinical Performance
than 3.5 years when they joined the responses to ESRD, the dialysis process Measures (CPM) Project Annual Report
study (DHHS/NIH, 2002). itself, anemia, endocrine disorders, etc. revealed that 74 percent of in-center
A recent retrospective study suggests The importance of nutritional status in hemodialysis patients who were
that the recommended minimal urea dialysis patients is recognized in the K/ prescribed erythropoietin during the last
reduction ratio of 65 percent may be too DOQI clinical practice guidelines for 3 months of 2000 had a mean
low to provide for an optimal mortality nutrition of chronic renal failure and in hemoglobin of equal to or greater than
benefit (Szczech, pages 738 through the ESRD CPM Project’s inclusion of 11gm/dL (which is approximately equal
745). Also, we recognize that there are serum albumin levels. Under the plan of to a hematocrit of 33 percent). This
several possible methods for calculating care condition (proposed § 494.90) we same report reveals that 63 percent of
Kt/V. In addition, a major concern for are proposing that the serum albumin peritoneal dialysis patients prescribed
accurate measurement of either URR or level be monitored on a monthly basis. Erythropoietin during the study period
Kt/V is that small differences in the The facility may track the serum had a mean hemoglobin of equal to or
method and timing of the blood draw albumin levels or any other pertinent greater than 11 gm/dL. This proposed
used for the postdialysis blood urea markers of nutritional status as part of rule uses anemia, as measured by the
nitrogen (BUN) blood sample can make its QAPI program. The goal is to identify hematocrit or hemoglobin level, as an
clinically important differences in the care system opportunities for improving element of patient outcomes for both
resulting hemodialysis adequacy patient nutritional outcomes and then hemodialysis and peritoneal dialysis
estimates. develop and implement interventions patients.
We acknowledge the need for that will potentially achieve the targeted Vascular access insertions and
consistency in the techniques used for outcomes. complications (for example, infection)
blood withdrawal as well as the method We are also proposing in have received increasing attention over
or formula used to calculate the Kt/V § 494.110(a)(2)(iii) that the QAPI the past few years. The current ESRD
value. We considered proposing program must include anemia network quality improvement project,
requirements that specified pre and management. Existing §§ 405.2137(b) Fistula First, is focused on vascular
postdialysis blood draw methods and and 405.2163(g) address the patient’s access. Complications associated with
Kt/V calculation methods that might hematocrit level as the indicator for the vascular access account for about 18.3
allow for more accurate benchmarking. necessity for administering percent of ESRD patient hospitalizations
However, we are not proposing a erythropoietin. In 1996, anemia was the (USRDS data from 2000) and is
specific methodology at this time, subject of the first National Cooperative associated with high financial costs and
because we believe it would be more Project conducted by the ESRD diminished quality of life for the
appropriate to recommend and networks. The reasons for selecting hemodialysis patient. Therefore, we are
encourage dialysis facilities to adopt the anemia both for the study and as an proposing in § 494.110(a)(2)(iv) that
methodology(ies) recommended by a outcome measure included: (1) The vascular access management be
consensus process such as the NKF–K/ prevalence of anemia among the included in the facility’s QAPI program.
DOQI. Medicare population; (2) a consensus Facilities should look for opportunities
Despite these difficulties, dialysis among the renal community that anemia to improve patient outcomes related to
facilities do use adequacy of dialysis as is a major quality-of-life problem for vascular access by reviewing ESRD
one of their benchmarks when dialysis patients and that proper drug Fistula First data and ESRD CPM Project
evaluating the quality of peritoneal and manipulation can improve this data in conjunction with the NFK-K/
hemodialysis patient care. The CMS condition; (3) the fact that commonly DOQI clinical practice guidelines for
ESRD CPM Project calculates the used measures of anemia (hematocrit vascular access. The ESRD CPM Project
adequacy of dialysis measures for and hemoglobin levels) are routinely and the USRDS Annual Data Report
hemodialysis and peritoneal dialysis collected by us when facilities bill provide regional and national data
patients (that is, URR and Kt/V) that can Medicare for erythropoietin on the pertaining to vascular access. The NKF–
be used by facilities and ESRD networks outpatient billing form; and (4) the K/DOQI clinical practice guidelines for
for benchmarking and comparison relatively straightforward and easily vascular access provide valuable
purposes. The CMS ‘‘Dialysis Facility accomplished process for monitoring information useful to a facility QAPI
Compare’’ website provides facility- hematocrit (or hemoglobin) levels. program regarding vascular access
specific adequacy-of-dialysis The United States Renal Data System management.
information in terms of what percentage (USRDS) Annual Data Report and the We are proposing in § 449.110(a)(2)(v)
of patients are receiving at least the ESRD CPM Project provides regional to require a patient safety component
minimal dose of dialysis (defined as a and national anemia data that allow for specific to medical injuries and medical
URR ≥ 65 percent). The use of minimal facility benchmarking. The NKF–K/ errors identification as part of each
performance levels for adequate dialysis DOQI clinical practice guidelines for facility’s QAPI program. The IOM
is widely used to allow for comparisons. Anemia of Chronic Kidney Disease published a report entitled ‘‘To Err is
However, facilities are encouraged to (Guideline 4) recommend an evidence- Human: Building a Safer Health
evaluate the needs of individual based target for hemoglobin of 11–12 g/ System,’’ that focused on the magnitude
patients and to deliver the amount of dL (and hematocrit of 33 to 36 percent) of medical errors, serious adverse events
dialysis that will promote optimal for erythropoietin therapy. In May 2000, and the risks of medical care in the
health outcomes for that patient. according to the 2001 Atlas of ESRD in United States (IOM, 2000). Medical
In addition, we are proposing in the United States (USRDS), 12 percent injuries and medical errors were also
§ 494.110(a)(2)(ii) that the dialysis of prevalent dialysis patients (that is, identified by the OIG as areas in which
facility’s QAPI program must also patients who have received chronic we should facilitate the development of
address nutrition. The nutritional status renal replacement therapy for at least 90 publicly accountable means for
of the dialysis patient impacts the days) with erythropoietin claims had identifying serious medical injuries and
patient’s morbidity, mortality, and hematocrits less then 30 percent and the analyzing their causes. The OIG found
that medical injuries are not OIG further recommended that we exert second Federal Register notice (69 FR
systematically monitored in dialysis leadership to facilitate the development 44012) was published and the package
facilities. of a common instrument that facilities including the draft survey and pilot test
The Renal Physicians Association and others could use to assess patient plan was submitted to OMB at that time.
(RPA), in partnership with the Forum of satisfaction. Many facilities do currently We will take into consideration the
ESRD networks and the Patient Safety use a patient survey as a means to assess practical difficulties and potential
Foundation, has formed a Patient Safety patient satisfaction and some have burden on facilities that may result from
Committee to address patient safety in experience in utilizing the results for requiring the use of a common
dialysis facilities. The Committee’s quality improvement efforts. instrument for assessing patients’
report describes the work of 42 We are proposing that facilities experience of care. However, we invite
stakeholder representatives from 34 monitor patient satisfaction and comment on the value of utilizing one
organizations as they engage in grievances as part of the QAPI program common survey that can yield
collaborative action planning (The and have the flexibility to use the information permitting comparisons of
Renal Physicians Association, 2001). method of their choice to meet this facilities across the nation.
The group identified challenges in requirement. Tracking patient We are also interested in how
improving patient safety, action options, satisfaction and grievances allow the facilities will assess the effectiveness of
and priorities. These participants have facility to identify any areas in which their internal grievance adjudication
expressed their commitment to patients have expressed concerns. The process, track the outcomes of patient
interorganizational collaboration on facility can analyze this information and grievances, and identify meaningful
selected actions in the launch of the determine what aspect of facility criteria for evaluation and tracking
next phase of this initiative. The Phase operations needs improvement. CMS purposes. We are soliciting comment on
I Report supports for the incorporation has an Intra-agency Agreement with how evaluating and tracking grievances
of patient safety activities into the AHRQ to develop a standardized patient can be used to improve patient
conditions for coverage for ESRD, to experience of care instrument and outcomes of care.
encourage universal engagement in survey protocol. In 2003, AHRQ 2. Monitoring Performance
patient safety participation. This conducted a feasibility study to assess Improvement (Proposed 494.110(b))
initiative provides resource information the feasibility and applications (that is,
that may be useful to facilities as they quality improvement and public We will specifically expect a facility
develop their QAPI program to reduce reporting) of a survey that measures whose treatment outcomes vary
medical errors and injuries. dialysis patients’ experience of care in significantly from accepted standards to
We propose in § 494.110(a)(2)(vi) that renal dialysis facilities. In the August identify the reasons for poor outcomes
if a dialysis facility reprocesses 25, 2003 Federal Register (68 FR and implement improvement projects to
hemodialyzers they must include reuse 51017), AHRQ published a notice that achieve expected outcomes. Therefore,
systems in their QAPI program. The identified and cataloged existing we are proposing in § 494.110(b) that
AAMI Reuse of hemodialyzers RD47 surveys and survey results made the dialysis facility must take actions
chapter (incorporated by reference in available to the team and presented the that result in performance
both the existing and the proposed exhaustive literature review that was improvements and must track
conditions) includes guidelines for a performed. In addition, a Technical performance to assure standards are met
reuse quality assurance program under Expert Panel consisting of ESRD and that improvements are sustained
section 14. Section 14 outlines quality patients and professionals was over time. This action stimulates the
assurance program areas that include: consulted. AHRQ’s ESRD Consumer provider to continuously examine and
(1) Records that serve as the quality Assessment of Health Plan Survey improve performance. In addition, we
assurance foundation; (2) schedule of (CAHPS) Feasibility Final Report and are retaining the requirement in existing
quality assurance activities; (3) patient the CMS response can be found on § 405.2134 that requires a dialysis
considerations; (4) equipment; (5) http://www.cms.hhs.gov/quality (follow facility to participate in ESRD network
physical plant; (6) supplies; (7) dialyzer the ESRD link to the CAHPS link). activities and pursue Network goals.
labeling; and (8) reprocessing and In the Feasibility Report, AHRQ
3. Prioritizing Improvement Activities
preparation for dialysis. Since these recommended that a standardized
(Proposed 494.110(c))
activities are the same in the proposed survey for measuring in-center
conditions for coverage as in the hemodialysis (ICH) patients’ experience The principal focus of the facility’s
existing conditions for coverage, there is and ratings of their care be developed continuous quality improvement
no additional regulatory burden. that could serve several important and program should be to establish a
Continuous quality management in the distinct purposes. An ICH CAHPS strategy to prioritize improvements in
reuse area is important to ensuring survey would provide information for facility services so that performance
patient safety. consumer choice, reports that facilities improvements lead to better outcomes
Assessment of patient satisfaction was can use for internal quality of care and increased satisfaction for
identified by the OIG as a means of improvement and external patients. To this end, the proposed
identifying patient concerns often benchmarking against other facilities, § 494.110(c) requires the dialysis facility
missed by the complaint process. The and finally, information that we can use to set priorities for performance
OIG recognized that patients play an for public reporting and monitoring improvement, considering prevalence
increasingly important role in their own purposes. The survey would be in the and severity of identified problems and
health care, and that techniques of public domain and consist of a core set giving priority to improvement activities
assessing patient satisfaction have of questions that could be used in that affect clinical outcomes. The
become increasingly sophisticated. We conjunction with existing surveys. facility must immediately correct any
concurred with the OIG’s In a January 30, 2004 Federal Register identified problems that directly or
recommendation. Therefore in notice (69 FR 4520) published as part of potentially threaten the health and
§ 494.110(a)(2)(vii), we are proposing the Paperwork Reduction Act (PRA) safety of patients. Under the continuous
that dialysis facilities include patient process, a draft survey and pilot test quality improvement system, facilities
satisfaction in their QAPI programs. The plan were issued. On July 23, 2004, a should be analyzing care processes that
determine how the facility’s measurement against baseline clinical We would periodically establish our
performance has affected—positively expectations. requirements and publish them in the
and negatively—patients, especially in The OIG’s Report of 2000 on External Federal Register. The standards that we
terms of what the patient actually Quality Review of Dialysis Facilities: A would use if this approach were
experiences. This proposed requirement Call for Greater Accountability adopted are as follows:
emphasizes the need for the facility to encourages the use of standardized • The minimum delivered threshold
focus on the areas of performance where performance measures to hold for Kt/V is—
problems have been specifically individual facilities accountable for —1.2 (single pool) for hemodialysis
identified, especially in areas relating to quality of care. OIG also recommends an patients (as specified in the NKF–K/
outcomes of patient care. By prioritizing approach that reflects a balance between DOQI Clinical Practice Guidelines For
areas of improvement, facilities can: (1) collegial and regulatory modes of Hemodialysis Adequacy: Update
Identify areas where outcomes indicate oversight. Their report addresses the use 2000, Guideline 4);
a need for improvement; (2) define of standardized performance measures —1.7 (weekly) for continuous
measures to improve outcomes; (3) both to engage in quality improvement ambulatory peritoneal dialysis
review implementation of improvement activities and to enforce minimum patients (as specified in the NKF–K/
actions; and (4) determine the success of standards. DOQI Clinical Practice Guidelines for
the actions implemented to improve the Supporters of an approach requiring Peritoneal Dialysis Adequacy: Update
performance measures. adherence to clinical standards for 2000, Guideline 15);
With an effective QAPI program, the ESRD facilities argue that: (1) There is —2.1 (weekly) for continuous cycling
dialysis facility can identify and specificity and relative homogeneity in peritoneal dialysis patients (as
reinforce the activities that it is the services delivered; (2) there are specified in the Peritoneal Dialysis
performing well and seek and respond significant risks to patient safety if care Adequacy: Update 2000, Guideline
to opportunities for improvement on a is not delivered appropriately; (3) the 16); and
continuous basis. We intend that as a renal community has been proactive in —2.2 (weekly) for intermittent
result of this proposed requirement the defining and using clinical standards; peritoneal dialysis patients (as
facility itself will be the catalyst that (4) there are correlations between specified in the Peritoneal Dialysis
precipitates continuous improvements. having acceptable NKF–K/DOQI- Adequacy: Update 2000, Guideline
The dialysis facility may choose to derived measures for adequacy of 16).
inform their patients of facility’s quality dialysis and anemia and positive • For anemia management, the
improvement activities and may want to outcomes for individual patients; and minimum required levels would be—
engage patients who are dialyzing in (5) the data systems supporting ESRD
program operations are comprehensive —A hemoglobin level of 11 gm/dL (as
their facility of these activities. The
and unique. specified in the NKF–K/DOQI Clinical
patient’s role in achieving quality
We are soliciting comments on the Practice Guidelines for Anemia of
improvement goals in areas such as
feasibility of using commonly agreed- Chronic Kidney Disease: Update 2000,
adequacy of dialysis and vascular access
should be acknowledged. Partnering upon clinical standards in our Guideline 4); or
requirements and enforcement efforts. —A comparable hematocrit of at least 33
with the patients to make improvements
In setting the minimum clinical percent (as specified in the NKF–K/
may be an important aspect of a
standards for performance, we would DOQI Clinical Practice Guidelines for
successful QAPI program.
The proposed QAPI Condition use selected clinical practice guidelines Anemia of Chronic Kidney Disease:
discussed in this section of the developed by the NKF–K/DOQI, which Update 2000, Guideline 4).
preamble encompasses a facility’s were developed with broad community To make this approach work, we
internal approach to improving the input and consensus, and have gained would need to address and mitigate the
quality of dialysis care. We are extensive national and international disadvantages that arise from assigning
considering putting into place, within acceptance. We would initially establish minimum numerical target values. We
these conditions, minimum clinical minimal expectations about adequacy of would be required to go through a
standards that would serve as external dialysis rates and anemia levels, but we rulemaking process each time we
stimuli for further improvements in the would continuously look to science for wanted to update the numerical values
quality of dialysis services. The updated standards. to correspond with any scientific
following is a discussion of how The method for applying these advances. NKF–K/DOQI clinical
minimum clinical standards could be standards would be to require that a practice guidelines for adequacy of
implemented and specific areas for dialysis facility must maintain dialysis and anemia are designed for
which we are soliciting public minimum clinical standards (that is, assessing individual patient care based
comment. adequacy of dialysis and anemia levels) on individual patient characteristics.
for all patients. If the patient’s outcomes We would need to address the issue of
4. Facility Specific Standards for did not meet the clinical expectations, using these as measures for facility-wide
Enforcement the interdisciplinary team would be performance. Can this effectively be
In this proposed rule, we have required to make adjustments. If the done or would a risk adjustor need to
discussed and taken an approach to patient is unable to achieve the be developed to avoid disadvantaging
quality assurance that relies exclusively minimum expected clinical outcomes, a facilities that have a different case mix?
upon the facility’s own process for member of the interdisciplinary team We are also soliciting comments on
setting, monitoring, and maintaining would need to enter an explanation in methods for using current NKF–K/DOQI
clinical standards as the basis for the patient’s medical records. If the clinical practice guidelines as facility-
evaluating its performance. This minimum expected clinical outcome is wide measures. For example, comments
approach is consistent with our overall achievable but is not being achieved, the on the use of the statistically based
approach to quality improvement. interdisciplinary team would be threshold measures of performance
However, dialysis care is provided in as expected to develop and implement an would be especially helpful. Under such
homogeneous a medical context as any improvement program to achieve and an approach, facilities in which a
service and may well be susceptible to maintain the expected outcome. predetermined portion of patients fail to
meet the selected clinical standards over F. Condition: Special Purpose Renal certification and approval process and a
some period of time, using a standard Dialysis Facilities (Proposed § 494.120) separate series of provider numbers for
deviation, percentile-based, or some [If you choose to comment on issues in ESRD facilities approved as special
other method, need to develop a this section please include the caption purpose renal dialysis facilities.
corrective action plan. We are In our deliberations regarding any
‘‘Special Purpose Renal Dialysis
specifically soliciting comments on this possible revisions to this condition, we
Facilities’’ at the beginning of your
issue. found that very few vacation camps
comment.]
If we were to codify a clinical have requested approval for certification
Special purpose renal dialysis
standards condition, the text would read as special purpose renal dialysis
facilities are dialysis units approved on
as follows: facilities. In March 2001, for example,
a short-term basis (currently, for no
Medicare records indicated that only
Condition: Clinical Standards more than 8 months) to provide dialysis
one vacation camp in the United States
The dialysis facility must maintain services to a group of patients otherwise
was certified as a special purpose renal
minimum clinical standards for all unable to obtain treatment in the
dialysis facility. We now question
patients. If the patient’s care does not geographic area served by the facility.
whether the requirements for vacation
The existing requirements for special
meet such standards, the camp renal facilities to be certified as a
purpose renal dialysis units are in
interdisciplinary team must make special purpose renal dialysis facility
§ 405.2164. That section states that
adjustments. If the patient is unable to are too onerous.
special purpose units must comply with A search on the web lists 36 camps for
achieve the minimum expected clinical
the conditions specified at §§ 405.2130 ESRD patients throughout the United
outcomes, a member of the
through 404.2164, with the exception of States. Some of the camps do not accept
interdisciplinary team must provide an
§§ 405.2134 to 405.2137 (that is, hemodialysis patients or accept
explanation in the patient’s medical
conditions relating to participation in hemodialysis patients for weekend only
records. If the minimum expected
network activities and the patient long- camps. These camps do not have a need
clinical outcome is achievable but is not
term care program). Existing for hemodialysis services. Other camps
being achieved, the interdisciplinary
§ 405.2164(b) requires a special purpose provide transportation to a certified
team must develop and implement an
facility to consult with the patient’s hemodialysis facility off the
improvement program to achieve and
physician to ensure that care provided campgrounds. Since the number of
maintain the patient’s expected level of
is consistent with the care plan and United States certified hemodialysis
general health.
long-term care plan required in existing facilities has doubled in the last decade
Standard: Performance Expectations § 405.2137. Existing § 405.2164(c) to approximately 4,000, transporting
(a) Dose of dialysis. The requires the ‘‘period of approval’’ (that campers to a nearby dialysis facility
interdisciplinary team must assist and is, Medicare certification), not to exceed may be feasible in many locations. It is
support facility patients in achieving 8 calendar months. not clear whether there remains a need
and maintaining the expected dose of In the May 11, 1983 Federal Register to continue to establish vacation camp
dialysis as specified by the Secretary (48 FR 21254), we published a final rule special purpose renal dialysis facilities
and published in accordance with the that provided for time-limited approval in the conditions for coverage.
notification requirements in paragraph of special purpose renal dialysis However, we are proposing to retain
(d)(i) of this section. facilities. These facilities were this condition in order to address the
(b) Anemia. The interdisciplinary established for two purposes: (1) To possible needs of patients who, as a
team must assist and support facility serve ESRD patients in a vacation area result of the emergency conditions
patients in achieving and maintaining (such as a vacation camp) when the area listed above, or participation in a remote
the expected hematocrit/hemoglobin is too remote from existing approved vacation camp, need dialysis services on
level as specified by the Secretary and facilities to allow convenient access by a short-term basis, and to ensure that
published in accordance with the patients; or when a convenient facilities providing this type of care are
notification requirements in paragraph approved facility does not have properly certified for participation in
(d)(i) of this section. The patient’s sufficient available capacity to serve a the Medicare program. We are also
hematocrit/hemoglobin levels must be number of vacationing patients; and (2) proposing to reduce the burden of the
measured at least monthly. to serve ESRD patients on an emergency requirements that a vacation camp must
(c) Additional clinical standards. basis when approved permanent meet in order to be certified as a special
Facilities are responsible for assuring facilities close due to natural disasters, purpose renal facility. Vacation camps
that their patients achieve at least a strikes, or bankruptcies, and the backup generally operate during the summer
minimum performance level on facilities in the area cannot months, when schools are closed, and
additional clinical standards that may accommodate the patients of the closed usually offer sessions lasting up to 2
be selected by the Secretary. The facilities. In the May 11, 1983 final rule, weeks. The task of meeting the ESRD
methodology and minimum the last provision was added conditions for coverage in order to offer
performance expectations will be specifically, ‘‘to ensure continuous a few camp sessions each year (with the
determined in accordance with the access to care in the event that an exception of the conditions relating to
NTTAA guidelines. approved permanent facility is closed participation in network activities and
(d) Notification. CMS will publish a because it cannot achieve adequate the patient long-term care program),
Federal Register document that revenues under the prospective may deter vacation camps from
proposes or finalizes— reimbursement system.’’ The providing hemodialysis services and
(i) The current minimum expected certification period of 8 months was seeking Medicare certification.
outcomes for dose of dialysis and determined to be appropriate in Therefore, we are proposing in
anemia referenced in paragraphs (a) and response to public comments urging § 494.120 that a special purpose renal
(b) of this section. that the original temporary certification dialysis facility would be approved to
(ii) Other standards upon proposal (of 6 months) be extended. furnish dialysis at special locations, that
development and acceptance of the Following the publication of the May is, vacation camps that serve ESRD
standards by the Secretary. 11, 1983 final rule, we developed a patients in a temporary residence, or
facilities established to serve ESRD • Governance (§ 494.180). arrangements to obtain these services
patients under emergency While the certification of a special with a laboratory certified under CLIA.
circumstances. A vacation camp must purpose unit is time-limited and the We are proposing in § 494.130 to
be operated under the direction of a patient’s treatment in the unit will be retain the existing requirements
certified renal dialysis facility that limited, we believe that every effort governing laboratory services in
assumes full responsibility for the care must be made to ensure that the quality § 405.2163(b) without change.
provided to patients. of care provided is comparable to that VI. Provisions of Proposed Subpart D:
Proposed § 494.120(a) maintains the provided to any dialysis patient in a Administration
8-month approval period in the existing Medicare-approved unit. However, we
§ 405.2164(c). In view of the history of believe requiring compliance with any A. Personnel Qualifications (Proposed
the few Medicare-certified special additional requirements would be too § 494.140)
purpose dialysis facilities, we believe a burdensome for a special purpose unit. [If you choose to comment on issues in
8-month approval period is adequate. We are proposing in § 494.120(d) to this section please include the caption
Proposed § 494.120(b) would retain retain the existing requirement that a ‘‘Personnel Qualifications’’ at the
the existing service limitation special purpose unit consult with the beginning of your comment.]
requirement (specified in § 405.2164(d)) patient’s physician, with an added The existing personnel qualifications
that limits the special purpose unit to provision that this consultation must of dialysis facility staff can be found in
providing services only to those patients occur before the initiation of dialysis in § 405.2102. Those requirements list the
who would otherwise be unable to the special purpose unit. This provision education and experiential requirements
obtain treatments in the geographic is added to ensure that the special for chief executive officers, physician-
locality served by the facility. purpose unit is fully aware of the directors, nurses responsible for nursing
In addition, we are proposing in patient’s current medical condition and services, dietitians, medical records
§ 494.120(c)(1) that a special purpose that the special purpose unit can practitioners, transplantation surgeons,
renal dialysis facility would be provide dialysis services consistent with and social workers.
approved as a vacation camp by the patient’s plan of care described at In existing § 405.2102(e), a physician-
demonstrating compliance with the § 494.90. director must be board eligible or board
following standards and conditions for In addition, we are proposing in certified in internal medicine or
coverage: § 494.120(e) to require the special pediatrics with at least 12 months of
• Infection control (§ 494.30)). purpose unit to document care provided experience or training in the care of
• Water quality (§ 494.40); if the to the patient and forward that patients at ESRD facilities.
facility uses home portable water documentation to the patient’s regular Existing § 405.2102(d) defines the
treatment systems, the facility would dialysis facility within 30 days of the nurse ‘‘responsible for nursing service’’
instead comply with the provision last scheduled treatment in the special as a person who is licensed as a
regulating home monitoring of water purpose unit. registered nurse by the State in which
quality (§ 494.100(c)(1)–(v)).
We are soliciting comments on practicing, with at least 12 months
• Reuse of hemodialyzers and other
whether vacation camps should experience in clinical nursing, with at
dialysis supplies if reuse is performed
continue to be included under the least 6 months experience in nursing
(§ 494.50).
special purpose renal dialysis facility care of patients with permanent kidney
• Patients’ rights (§§ 494.70(a) and
condition for coverage. failure or patients undergoing kidney
(c)).
• Laboratory services (§ 494.130); a G. Laboratory Services (Proposed transplantation, or 18 months of
facility would be required to have a plan § 494.130) experience in nursing care of the patient
for obtaining laboratory services for on maintenance dialysis. This section
[If you choose to comment on issues in also states that if the same individual is
cases when it is necessary for patient
this section please include the caption assigned responsibility for self-care
safety.
• Medical director responsibilities for ‘‘Laboratory Services’’ at the beginning dialysis training, that individual must
patient care policies and procedures of your comment.] have at least 3 months experience in
(§ 494.150(c) and (d)). In 1994, we revised existing training ESRD patients for self-care.
• Medical records (§ 494.170). § 405.2163 to stipulate that the dialysis Existing § 405.2102(b) defines a
We are proposing in § 494.120(c)(2) to facility must make available laboratory dietitian as a person who—
specify that a special purpose renal services (other than tissue pathology • Is eligible for registration by the
dialysis facility certified due to and histocompatibility) and that all American Dietetic Association under its
emergency circumstances may provide laboratory services must be performed requirements in effect on June 3, 1976
services only to those patients who by an appropriately certified laboratory and has at least 1 year of experience in
would otherwise be unable to obtain in accordance with the Clinical clinical nutrition; or
treatments in the geographical areas Laboratory Improvement Amendments • Has a baccalaureate or advanced
served by the facility and is approved by (CLIA) regulations at 42 CFR 493. degree with major studies in food and
demonstrating compliance with Existing § 405.2163(b) also requires a nutrition or dietetics and at least 1 year
§ 494.120(c)(1) and the following dialysis facility that furnishes laboratory of experience in clinical nutrition.
additional conditions: services to furnish these services in Existing § 405.2102(f) defines a social
• Compliance with Federal, State, accordance with applicable worker as a person who is licensed in
and local laws and regulations requirements established for the State in which practicing, has
(§ 494.20). certification of laboratories under the completed a course of study with
• Physical environment (§ 494.60). CLIA. Independent dialysis facilities specialization in clinical practice at, and
• Patients’ rights (§§ 494.70(a) must be certified under CLIA to perform holds a masters degree from, a graduate
through (c)). and bill most laboratory tests to the school accredited by the Council on
• Personnel qualifications Medicare program. This section also Social Work Education, or has served
(§ 494.140). allows a dialysis facility that does not for at least 2 years as a social worker
• Medical director (§ 494.150). provide laboratory services to make with at least 1 year in a dialysis or
transplantation program before skilled professionals. These 2. Nursing Services (Proposed

September 1, 1976 and consults with a professionals would meet the § 494.140(b))
social worker holding a masters degree. requirements in this proposed rule and In § 494.140(b) we propose a Nursing
ESRD is an extremely complex would adhere to the facility’s policies Services standard that would include
disease requiring highly technical and and procedures. The dialysis facility has the necessary qualifications for 4 nurse
complex treatment, and patients with the flexibility to assign specific duties to categories: (1) The nurse responsible for
this disease have special needs that each staff member (either employee or nursing services in the facility; (2) the
require highly specialized care that can contractor) who provides services in the nurse responsible for training in self-
only be provided by qualified facility, as long as the required care; (3) the charge nurse with
personnel. As the demographics of the outcomes required are being met. responsibility for each patient shift; and
dialysis population continue to change,
producing a more elderly patient 1. Medical Director (Proposed (4) any nurse who provides care and
population with more co-morbid § 494.140(a)) treatment in the unit.
conditions, direct patient care needs We are proposing in § 494.140(b)(1)(i)
In proposed § 494.140(a) we would to retain the existing requirement at
and the skill needed to meet those needs maintain some of the qualification
will continue to increase. Also, as we § 405.2162(a) that each facility employ
requirements for a physician director. at least 1 full time qualified nurse
move away from unnecessary process However, we propose to change the
and procedural requirements in the responsible for nursing service in the
word ‘‘physician’’ to ‘‘medical’’ to be unit. In proposed § 494.140(b)(1)(ii) and
conditions for coverage towards better consistent with current standards of
patient outcomes, it becomes even more (iii) we would maintain the existing
practice in the industry. The medical requirements that the nurse responsible
important to have qualified, director of a facility is responsible for
experienced, and well-trained staff to for nursing services in the unit be a
the development of patient care policies registered nurse who meets the practice
achieve the targeted clinical outcomes and the delivery of services. For this
for each patient. requirements of the State in which he or
reason, we chose to require that the she is employed, and has at least 12
In the past, industry representatives medical director be trained in
have supported the retention of months of experience in clinical nursing
nephrology and have experience in the with an additional 6 months of
minimum personnel qualifications in care of dialysis patients to emphasize
the conditions, and we are proposing to experience in providing nursing care to
the need for experience in managing patients on maintenance dialysis.
retain most of the existing personnel
dialysis care and associated medical We are proposing in § 494.140(b)(2) to
qualifications requirements in this
conditions. The medical director of a specify the requirements for the nurse
proposed rule. We are also proposing
dialysis unit must have a thorough responsible for training in self-care. For
changes where we believe they are
knowledge and understanding of the a detailed discussion of these nursing
needed, and those changes are
complexity of ESRD and its effects on requirements see section V.D.1. of this
discussed in the preamble discussion
the dialysis patient. preamble.
that follows.
In § 494.140, we are proposing to The existing regulation at § 405.2102 We are proposing in § 494.140(b)(3)(i)
consolidate all of the personnel requires that the director of the facility to retain with minor modifications the
qualifications requirements into a single be either board certified or board existing requirement at § 405.2162(b)(1)
condition, entitled ‘‘Personnel eligible. There has been considerable that the individual responsible for each
qualifications.’’ In addition, proposed disagreement within the medical shift be a licensed health professional
§ 494.140 would require that a dialysis community as to whether board such as a registered nurse (RN) or a
facility’s staff (whether employees or certification or eligibility is an licensed practical nurse (LPN) who
contractors) meet the personnel important indicator of professional meets the practice requirements of the
qualifications and demonstrated competence. In view of the diversity of State in which he or she is employed.
competencies necessary to serve the opinion in the industry and the absence We recognize that in some instances, a
general needs of its patients. We also of any indication that the quality of care licensed practical nurse is able to
propose that the dialysis facility’s staff would decline if this requirement were demonstrate the knowledge, training,
must have the ability to sustain and deleted, we are proposing to eliminate and experience to serve as the charge
demonstrate the skills needed to the requirement that the medical nurse in a dialysis unit and this is
perform the specific duties of their director be either board certified or currently the practice in some units. In
positions. board eligible. Thus, we propose to proposed § 494.140(b)(3)(ii) we would
We recognize that facilities are not require only that the medical director be specify that the charge nurse must have
always able to directly employ a physician who has completed a board- at least 12 months experience in nursing
individuals to perform all required approved training program in care, including 3 months of specialized
services; and therefore, facilities may nephrology and has at least 12 months experience in providing clinical nursing
continue to furnish services through experience providing care to patients care to patients on maintenance
qualified personnel by arrangement. receiving dialysis. We are retaining the dialysis.
Any position in a facility may be filled alternate option for situations when a We are proposing in § 494.140(b)(4)
by a contracted employee, but the physician who meets this criterion is that each nurse who provides care and
contracted employees must meet the not available that allows another treatment to patients must be either a
personnel requirements as well as the physician to direct the facility, subject registered nurse or a licensed practical
demonstrated skills and competencies to the approval of the Secretary. In the nurse who meets the practice
in proposed § 494.140 to ensure that absence of a compelling reason for requirements of the State in which he or
patients receive quality care from all maintaining the grandfathering she is employed.
personnel. provision for the physician director
The expected outcome is the under § 405.2102(e)(2), we have not 3. Dietitian (Proposed § 494.140(c))
coordinated, comprehensive incorporated this provision in our Renal dietitians are important and
interdisciplinary delivery of appropriate proposed personnel qualifications for necessary members of the patient’s
and effective services provided by the medical director at § 494.140(a). interdisciplinary care team. Some of the
responsibilities of the renal dietitian are: requirement that the social worker have other requirements for reuse technicians
(1) Counseling patients on management a master’s degree. Since the extension of are described in specific sections of the
of protein, sodium, potassium, Medicare coverage to individuals with AAMI guidelines, which have been
phosphorus, and fluid controlled diets, ESRD, the ESRD patient population has incorporated by reference in existing
translating the chemistry of these limits become increasingly more complex from § 405.2150(a)(1) and in this proposed
into meals for patients; (2) monitoring both medical and psychosocial rule (see § 494.50).
vitamin and mineral supplementation, perspectives. In order to meet the many As we researched this issue, we
including iron levels and their effect on and varied psychosocial needs of this reviewed past and current efforts by the
erythropoietin; (3) managing glycemic patient population, we believe qualified States to regulate dialysis technicians.
control of diabetic patients by master’s degree social workers (MSW) The States are currently using a variety
manipulation of diet; and (4) assessing trained to function autonomously are of approaches and methodologies to
nutritional status by using clinical and essential. Social workers must have regulate dialysis technicians, including
biochemical measures. knowledge of individual behavior, minimum qualification requirements,
We believe that these kinds of family dynamics, and the psychosocial mandatory competency testing,
activities will require a dietitian with impact of chronic illness and treatment registration, licensure, and certification.
specialized experience in clinical on the patient and family. The dialysis We also looked at the typical scope of
nutrition. The specialized training and patient needs psychosocial evaluations, practice for this occupation in dialysis
experience would ensure that dialysis a treatment plan based on the patient’s facilities, and took into account the
facilities have a dietitian knowledgeable current psychosocial needs, and direct public policy positions and statements
about medical nutrition therapy, social work interventions. Facility social from national associations and
physiology, and food composition. This worker services include counseling organizations that advocate uniform
specialized knowledge is critical if a services, long-term behavioral and Federal guidelines for dialysis
dietitian is to effectively manage the adaptation therapy, and grieving technicians.
complex tasks necessary in treating a therapy. We believe that MSW training Arizona, Ohio, and Oregon now
dialysis patient, so the patient is able to provides the necessary education and require dialysis technician certification
manage his or her own disease. experience in these areas. We have via a nationally standardized
We are proposing in § 494.140(c) to removed the requirement for examination. California and Texas
retain requirements comparable to the specialization in clinical practice, require specific training and testing, but
existing requirements laid out under the because this designation is not available allow a nationally standardized
definition of ‘‘qualified personnel’’ at in all States and may prove to be a certification examination to be
§ 405.2102(b). We propose that the barrier to social workers entering substituted for their training and testing
dialysis facility dietitian be a registered practice in the dialysis arena.
dietitian with the Commission on requirements. Georgia identifies a
While nonprofessional personnel may
Dietetic Registration, the official standardized training program for
serve in a supportive capacity, we do
credentialing agent for the American hemodialysis patient care technicians
not believe they can be employed in
Dietetic Association. We also propose (PCTs), but does not require technicians
place of a fully-credentialed MSW. We
that the dietitian meet the practice to pass a national certification test
recognize that dialysis patients also
requirements of the State in which he or unless a facility’s training program fails
need other essential services including
she is employed and have a minimum to provide adequate training. The three
transportation and information on
of 1 year of professional work Medicare benefits, eligibility for organizations that provide nationally
experience in clinical nutrition as a Medicaid, housing, and medications, recognized standardized certification
registered dietitian in order to qualify to but these tasks should be handled by examinations are listed later in this
perform the special responsibilities of other facility staff in order for the MSW section of the preamble.
renal dietitians discussed above. to participate fully with the patient’s Other States including Connecticut,
interdisciplinary teams so that optimal South Dakota, Kentucky, Utah, Virginia,
4. Social Worker (Proposed Washington, New Mexico, and the
outcomes of care may be achieved.
§ 494.140(d)) District of Columbia require certain
We are proposing in § 494.140(d) to 5. Dialysis Technicians (Proposed training and competencies for dialysis
retain the existing requirements for § 494.140(e)) technicians. States with past or ongoing
social workers at § 405.2102(f), except There are no Federal requirements for efforts to regulate the practice of
for the ‘‘grandfather clause’’ which dialysis technicians in the existing unlicensed dialysis technicians and
exempted individuals hired prior to the ESRD conditions for coverage with the technical staff include Colorado,
effective date of the existing regulations single exception of reuse technicians, Illinois, Louisiana, Maryland, New York
(that is, September 1, 1976) from the who are covered by the AAMI and Oklahoma.
social work master’s degree requirement guidelines. When the existing Some national associations (for
and substituted an experience criterion, conditions for coverage were published example, the American Nephrology
which is 1 year in a dialysis setting; and in 1976, dialysis technicians were an Nurses Association (ANNA) and the
a criterion requiring including a emerging occupation. At that time it was National Association of Nephrology
consultative relationship with a social common for one nurse to provide Technicians (NANT)) have advocated
worker with a master’s degree. Since dialysis care to two dialysis patients at uniform training and certification
this clause only applied to social a time. Currently, dialysis patient care requirements for dialysis technicians for
workers without a master’s degree, technicians are the primary caregivers several years and continue to advocate
already employed in a dialysis or in most facilities and it is not unusual for these measures at the State and
transplantation setting as of 1975, we for a single technician to provide national level. Their primary concern is
question whether there is any need to dialysis care to three or four patients at to ensure that care is provided by
retain it. a time. qualified and trained health care
We recognize the importance of the The discussion that follows applies workers who are able to demonstrate the
professional social worker, and we primarily to dialysis technicians who necessary competencies to perform the
believe there is a need for the provide direct patient care. Training and assigned duties of their positions.
Since 1990, NKF’s Public Policy • Intraperitoneal administration of have adopted certification are not in
Board has been interested in evaluating sterile electrolyte solutions and heparin agreement regarding which certification
and defining the proper role of, and for peritoneal dialysis. test is the most effective. Some States
training needed by, dialysis technicians. • Monitoring patients during dialysis. have designed, or are in the process of
In 1992, NKF’s Dialysis Technician Task • Taking vital signs. designing, their own competency
Force published an extensive list of • Documenting tasks and patient examinations, while others have
tasks that define the ‘‘patient care role observations. recognized one or more of the existing
description’’ as well as the appropriate • Equipment maintenance and repair. examinations as evidence of compliance
areas of required training (NKF, pp. • Water systems monitoring and with their requirements. Finally, a
229–232). The authors of that article maintenance. Federal certification requirement
advocated, among other things, that • Quality control measures. entailing mandatory competency
• Inventory. examinations would necessitate
technicians should have at least a high
One of the options we considered was
school diploma or equivalency; take additional costs for transportation,
requiring certification for dialysis
training courses in the basic sciences; lodging, fees, and preparatory materials
technicians. Certification is a voluntary
report directly to a registered nurse; and associated with the examination. Those
process by which recognition is granted
be able to effectively perform specific costs would have to be borne by either
to an individual who has met certain
tasks, subject to individual State the individuals seeking certification, the
qualifications. Certification is typically
licensure and scope of practice laws and dialysis facilities, or both. Without clear
awarded upon the successful
regulations. The article also evidence that certification would
completion of an approved competency produce better patient outcomes, we are
recommended a basic training course
examination. The goal would be a reluctant to propose any new
curriculum for renal technicians which
national, standardized requirement for requirements that would drive up costs
included, among other things: (1) An
education, training, and competency for technicians in current practice,
introduction to dialytic therapies; (2)
testing for dialysis technicians. In dialysis facilities, or both. Therefore, for
principles of hemodialysis; (3) the
considering this option, we noted that these reasons, we believe it is more
effects on the patient of kidney failure;
some States have chosen to develop prudent at this time, not to propose a
(4) dialysis procedures; (5) hemodialysis
their own competency examinations or national certification requirement for
devices; (6) water treatment; (7)
to recognize competency examinations dialysis technicians. Instead, we are
reprocessing (if applicable); (8) patient
prepared and administered by one of the proposing in § 494.140(e) a set of
education; (9) infection control; and (10)
three national organizations that minimum qualifications for dialysis
the techniques used in quality assurance
provide competency testing and technicians that will include a
and continuous quality improvement.
The adverse outcomes for dialysis certification for dialysis technicians. minimum education requirement,
patients of improper care from Those organizations are the Nephrology minimum requirements for on-the-job
inadequately trained dialysis Nursing Certification Commission training and experience, and proposals
technicians could include blood leaks, (NNCC), the Board of Nephrology for the composition of an effective
access damage, incorrect dialysis Examiners Nursing and Technology technician-training program.
concentrate, infection, and hypotension. (BONENT), and the National We are proposing in § 494.140(e)(1) to
Increased numbers of patient Nephrology Certification Organization specify that dialysis technicians meet all
hospitalizations, which in turn result in (NNCO). The common goal of these applicable State requirements (for
higher costs to both public and private organizations is to administer an example, credentialing, certification,
payers, could also be a direct outcome effective test that serves as a basis to and licensure) in the State in which
of poor patient care from dialysis certify technicians for initial or more they are employed. As stated above, we
technicians. advanced competencies in knowledge, believe technicians in any Medicare-
In most dialysis facilities, renal skill and abilities. approved facility should comply with
technicians now provide a large In our deliberations on whether to any existing State requirements for their
percentage of direct patient care propose Federal requirements for profession.
services. In most instances, care is dialysis technicians engaged in direct In proposed § 494.140(e)(2) we would
provided under the supervision of a patient care, we are reminded that require dialysis technicians to have at
registered nurse. However, the degree of Medicare has had a longstanding policy least a high school diploma or
supervision and the technician-to- of respecting State control and oversight equivalency. We are proposing this
patient ratio will often vary from facility of health professionals. The Congress criterion for two reasons. First, some of
to facility. has left this licensure function to the the States that regulate dialysis
A wide variety of tasks are performed States and Medicare recognizes State- technicians (for example, Connecticut
by dialysis technicians, depending on defined scope-of-practice laws under and Ohio) require dialysis technicians
the limitations of State law. These tasks which health care professionals are to have a high school education or
include, but are not limited to the licensed in the United States. equivalency.
following: After careful consideration, we do not Second, other States (for example,
• Preparing dialysis apparatus. believe it would be prudent to propose Texas, California, Oregon, and New
• Performing equipment safety a national certification requirement for Mexico) that require (among other
checks. dialysis technicians at this time. We options) certification by one of the
• Initiating dialysis (including take this position for several reasons. national certification organizations (that
cannulation and venipucture with large First, there is no consensus within the is, NNCC, NNCO, BONENT) also require
gauge needles). renal community regarding the efficacy a high school diploma or equivalency
• Intravenous administration of of technician certification to produce because that is a prerequisite for taking
heparin and sodium chloride solutions. improved patient outcomes of care. the certification examination. We
• Subcutaneous or topical Second, there is no standardized concur with the position taken by States
administration of local anesthetics in national certification test at this time, that regulate dialysis technicians and
conjunction with placement of fistula and the individuals and organizations, the national technician certification
needles. including the States, who advocate or organizations because we believe a
minimal education requirement is patients, including disruptive or average of 12 medications, which

appropriate and necessary to enable an challenging patients. In addition, a increases the risk of adverse drug
individual to complete the wide variety registered nurse is best equipped, events; and (2) the patients’ have
of patient care functions. through training and experience, to complex pathophysiology, which affects
We are proposing in § 494.140(e)(3) to ensure that every technician can how medications can be used safely
require that each technician complete at demonstrate the basic skills needed to (Kaplan, pp. 316–319). There are a
least 3 months experience, following the provide routine patient care (for number of publications that describe the
facility’s training program (also required example, initiating, monitoring, and contributions of pharmacists to the
by § 494.180(b)(5)). This experience terminating dialysis; proper aseptic improved care of various patient
must be gained under the direct techniques; recognizing and reporting populations while simultaneously
supervision of a registered nurse with a medical errors; and dealing with reducing medication-related costs.
focus on the operation of kidney medical emergencies). For all of these Therefore, we have proposed, as part
dialysis equipment and machines and reasons, we believe a 3-month period of of the new patient assessment condition
providing direct patient care with direct supervision by a registered nurse at § 494.80(a)(3), that facilities conduct
particular sensitivity to the management is essential to ensure patient health and a laboratory profile and medication
of difficult patients. We see dialysis safety and to ensure that dialysis history on each patient as part of their
technician training as a cycle that technicians that provide direct patient comprehensive patient assessment.
proceeds from written instruction that care can do their part to ensure that the However, we have not proposed a
would provide a basic foundation of unit meets its patient outcomes goals. specific requirement for pharmaceutical
knowledge, to a necessary period of on- We invite comments on the 3-month services. We invite comments regarding
the-job training under the supervision of training proposal. what role, if any, the pharmacist should
a knowledgeable professional trained in We are proposing implementation of play within the dialysis facility as well
all aspects of patient care, including a training program that is specific to as the facility’s appropriate
medical emergencies. technicians who monitor the water responsibility for pharmaceutical
While written instruction is essential, treatment system. Water purity is services and the efficient use of
we also believe properly supervised on- important to protecting patient safety medications in the new conditions for
the-job training must follow to allow the and the water must be adequately coverage.
technician to take maximum advantage monitored and properly collected for
of the information provided in the B. Condition: Responsibilities of the
testing as specified at proposed
training program before the dialysis Medical Director (Proposed § 494.150)
§ 494.40. The technician who carries out
technician is allowed to provide direct water testing and monitoring of the [If you choose to comment on issues in
patient care with minimal supervision. water treatment system must be this section please include the caption
We believe 3 months of effective on-the- appropriately trained following a ‘‘Responsibilities of the Medical
job, supervised training is necessary program that has been approved by the Director’’ at the beginning of your
before a technician is permitted to care medical director and governing body. comment.]
for patients without close and direct Typically, facility patient care The requirements for the director of a
supervision. technician training programs contain a renal dialysis facility are found in
We have made this proposal for water treatment system training module. existing § 405.2161. Section 405.2161
several reasons. As discussed in section This module may form the basis of a requires the director to be a physician
VI.A.2 of this preamble, a registered training program that could be used to who devotes sufficient time to his or her
nurse has the necessary professional train a water treatment technician. director responsibilities to plan,
training and expertise to coordinate care organize, conduct, and direct the
in the unit, perform patient assessments, 6. Other Personnel Issues professional ESRD services of the
respond to clinical questions from staff Existing § 405.2136(f)(1)(vi) requires facility. Existing § 405.2161 also states
and patients, and coordinate ongoing the facility have patient care policies that the physician-director may also
care. Dialysis technicians, as the that cover pharmaceutical services. serve as the chief executive officer
primary caregivers in most dialysis There is currently no Federal (CEO) of the unit.
units, function as extensions of the requirement for a pharmacist to play a Existing § 405.2161(a) states that the
unit’s professional nursing staff. We role on the multidisciplinary team director must meet the qualifications
believe it is essential that a unit’s within the dialysis facility. The dialysis described in § 405.2102 (that is, be
registered nurse provide the ‘‘hands-on’’ facility generally has some access to the board eligible or board certified and
direct supervision to impart this pharmacist who is dispensing have at least 12 months of experience or
training to new dialysis technicians. For outpatient medications to the dialysis training in the care of patients in ESRD
example, in the patient outcomes patient. A hospital-based dialysis unit facilities). Existing § 405.2161(b)
environment these regulations are might be able to use the hospital requires the physician-director to: (1)
designed to encourage, it is essential pharmacist as a resource. There may Participate in the selection of a suitable
that technicians understand the also be limited pharmacy resources treatment modality for all patients
significance of continuous quality available to the average dialysis facility treated in the unit; (2) assure adequate
improvement (that is, collecting data, that is administering intravenous drugs training of nurses and technicians in
keeping logs, the clinical importance and making adjustments to a patient’s dialysis techniques; (3) assure adequate
and meaning of target patient outcome medication regimen. It has been monitoring of the patient and the
measures, and recognizing and reporting suggested by some in the renal dialysis process, including periodic
medical errors). We also believe a community that there should be a monitoring of self-dialysis patients; (4)
registered nurse can be very effective in requirement within the proposed assure the development of a patient care
instructing new dialysis technicians in conditions for coverage for each dialysis policy and procedures manual and its
necessary aspects of patient care, such facility to ensure a routine assessment of implementation; and (5) assure that
as ensuring patient privacy and patient medications by a pharmacist. patient teaching materials are made
confidentiality, and demonstrating good The reasons for this recommendation available for self-dialysis and home
interpersonal skills when dealing with are: (1) Most dialysis patients take an dialysis patients.
The June 2000 OIG Report was an we believe the medical director should We are proposing in § 494.150(c)(1)
extensive review to ascertain our be given the responsibility to ensure that the medical director participate in
effectiveness in monitoring the ESRD that all staff that treat patients actively the development, periodic review, and
program. The report contained several participate in the facility’s QAPI approval of the patient care policies and
recommendations regarding ways we program. In that capacity we would procedures manual. We are also
should revise the ESRD conditions for expect the medical director to make a proposing in § 494.150(c)(2) that the
coverage in order to strengthen the special effort to educate and encourage medical director, as the individual with
accountability of dialysis facilities that facility staff, including attending direct responsibility for the manner in
participate in the Medicare program. physician and nonphysician staff, who which patient care is administered
One of those recommendations was to have not actively participated in the within the facility, be responsible to
reinforce the accountability of the facility’s QAPI program. In those rare ensure that these patient care policies
dialysis facility’s medical director for instances when in-house or attending and procedures are adhered to by staff
the provision of patient care. physician or nonphysician staff will not who treat patients in the dialysis
Specifically, the report stated the actively participate in the facility’s facility, including attending physician
following: ‘‘While the governing body of QAPI program, we would expect the and nonphysician staff. In those
the facility is the basic source of medical director to refer those instances when facility staff or attending
accountability, the medical director individuals to the facility’s governing physicians or nonphysicians have not,
should clearly be empowered as the on- body through its CEO or administrator. or will not, follow the facility’s written
site agent most directly responsible for The governing body (see § 494.180) has patient care policies and procedures, we
the quality of care being delivered. In the final legal responsibility and would expect the medical director to
this capacity, the medical director authority for the operation of the facility educate and encourage those
should clearly have the authority to and the ultimate responsibility for the individuals to follow facility policies
develop and monitor quality facility’s compliance with Federal and procedures. In those rare instances
improvement efforts, to serve as an Medicare regulations. when the medical director has been
educational resource for medical and In assuming operational responsibility unsuccessful in achieving compliance,
nursing staff, and, when individual staff for QAPI, this requirement emphasizes we would expect the medical director to
are not performing adequately, to bring the importance of the medical director refer the matter to the facility’s
that to the attention of the facility’s utilizing the best practices within a governing body (see § 494.180).
designated governing authority.’’ strong QAPI program. Under this We are proposing in § 494.150(c)(2)(ii)
In response to the OIG’s requirement, we would expect the that the medical director ensure that the
recommendations, we are proposing in facility’s medical director to seek and interdisciplinary team follows the
§ 494.150 to retain medical director as a use comparative data with other facility’s patient discharge and transfer
separate condition for coverage and
facilities when available and use the policies and procedures described in
strengthen the medical director’s role.
facility’s historical data to demonstrate § 494.180(f). In section VI.E9 of this
Section § 494.150 would require each
internal improvements in outcomes over preamble, we proposed that all patients
dialysis facility to have a medical
time. This standard also underscores the be informed of a facility’s transfer and
director who meets the qualifications for
medical director’s ongoing discharge policies and be given 30 days
that position at § 494.140(a) and who is
responsibility to ensure that each notice in advance of a facility reducing
responsible for the delivery of patient
patient treated in the facility achieves or terminating on-going care. In
care and patient outcomes in the
the best possible outcomes of care. addition, we are proposing that the
facility.
We are proposing in § 494.150(a) to We propose in § 494.150(b) to retain medical director monitor and review
assign the operational responsibility for the existing requirement at each involuntary patient discharge to
the facility’s quality assessment and § 405.2161(b)(2) for the medical director ensure that the patient’s
performance improvement (QAPI) to ensure that staff in the unit are interdisciplinary team has performed
program (§ 494.110) to the medical adequately trained. We believe that all the tasks required in § 494.180(f).
director. While the facility’s governing patient care personnel in the facility In a January 2002 report (Building on
body is ultimately responsible for should receive the necessary education the Experiences of Dialysis
allocating the necessary resources (for and ongoing training to furnish services Corporations, OEI–01–99–0052), the
example, dedicated staff and computers) effectively, efficiently, and completely. OIG recommended that the ESRD
to establish a QAPI program, we believe We are proposing in § 494.150(c)(1) to conditions for coverage specify the
the medical director is best qualified to retain the existing requirement responsibilities of the Medical Director
ensure that the facility’s QAPI program § 405.2161(b)(4) for the medical director in situations when there is a quality
is effectively developed, implemented, to assure the development of a ‘‘patient problem related to an ESRD facility
maintained, and periodically evaluated. care policies and procedures manual’’ physician. The OIG recommendation
We are also proposing that the medical for the facility. While our goal follows:
director ensure that all clinical staff in throughout this proposed rule has been CMS should also address in the Conditions
the facility, including attending to eliminate unnecessary process what medical directors are expected to do
physicians, actively participate in requirements, we believe that a when a quality problem is attributable to an
achieving the performance goals and comprehensive patient care policies and attending physician who is not performing
objectives specified in the facility’s procedures manual within a dialysis adequately. It should make clear that: (1)
QAPI program. It is essential for an unit is an essential reference for clinical Medical directors have the authority to
effective QAPI program that the staff within the unit. The manual is also conduct or initiate peer review and to
an opportunity for the medical director address performance problems through
attending physician and nonphysician
directed education, and (2) for more serious
staff, who treat patients in the facility, to incorporate improved treatment situations, the medical director’s
‘‘buy-in’’ to the facility’s quality methodologies and current medical responsibility to report a physician to an
improvement initiatives and actively practices into day-to-day patient care authoritative body, such as the End-Stage
participate in achieving the facility’s within the facility in order to ensure Renal Disease Network and/or the State
QAPI goals. In order for this to happen, better outcomes of care. Medical Board.
We are soliciting comments on adding • Provides a focal point for maintain complete, accurate, and
language to this regulation under the coordinating the actions of the accessible medical records on all
Medical Director condition to more interdisciplinary team; patients, including home dialysis
specifically state Medical Director • Provides an accurate picture of the patients for whom the facility has
responsibilities in regard to ESRD patient’s progress in achieving care signed a backup agreement with a DME
facility attending physicians. goals; supplier to provide support services to
• Provides the team interdisciplinary the patient or whose care is under their
C. Relationship With ESRD Network members with data for evaluating and supervision. The proposed rule
(§ 494.160) documenting the quality and emphasizes that a facility must maintain
[If you choose to comment on issues in appropriateness of care delivered; and complete medical records for all
this section please include the caption • Provides evidence of the facility’s patients under its supervision,
‘‘ESRD Network’’ at the beginning of implementation of policies and including home patients.
your comment.] procedures relating to patient care. We propose to no longer prescribe the
The existing Medical records elements that facilities must include in
Existing §§ 405.2110 through
requirements at § 405.2139 contain a the patient medical record. Instead, we
405.2113 contain provisions that relate
large number of prescriptive believe that facilities should have the
to the designation of the ESRD
requirements. These requirements flexibility to decide what information
networks, the functions of the ESRD
include the following: must be included in the medical record
networks, and the role of the medical • Requires that each medical record as long as the services provided are
review boards. These provisions focus contain sufficient information to consistent with the patient’s diagnosed
primarily on the role and identify the patient, justify the diagnosis condition. We believe facilities will
responsibilities of the ESRD networks, and treatment, and document the results document patient outcomes (such as
rather than establishing conditions for accurately. Kt/V and hematocrit levels), results of
Medicare coverage that must be met by • Prescribes the content of the assessments and reassessments (see
dialysis facilities. Therefore, we are not medical record to include, for example, § 494.80), changes in the care plan (see
incorporating these requirements in the patient assessment information, § 494.90), and other pertinent
proposed ESRD conditions for coverage. evidence the patient was informed of information even though the elements
These regulations will remain in part the assessment, identification and social are not prescribed, because this
405 and any revisions will be addressed data, consent forms, medical and information is necessary to track patient
in a separate notice of proposed nursing history, diagnostic and progress, implement the patient care
rulemaking. therapeutic orders, observations and plan, record information needed to
While we believe that the role and progress notes, laboratory results, and, if comply with the patient discharge or
responsibilities of the networks do not necessary, a discharge summary. transfer procedure (see § 494.150(e)),
need to be included in the proposed • Requires written policies and and effectively manage a facility quality
conditions for coverage, we believe that procedures to protect medical records assessment and performance
dialysis facilities must continue to share information. improvement program (see § 494.110).
information with the networks. Thus, • Requires the facility to designate a The patient’s plan of care condition (see
we propose to require at § 494.160 that medical records supervisor and includes § 494.90(b)) would require the facility to
each facility cooperate with the ESRD a list of duties and responsibilities for monitor and track patient progress
network serving its designated area in that individual. toward the desired outcomes, and
fulfilling the terms of the Network’s • Requires medical records to be inherent in these requirements is the
scope of work contract with CMS, completed promptly and states that all need to document patient results in
similar to the requirement under clinical information pertaining to the some form.
existing § 405.2134 concerning patient be maintained in a centralized We are proposing at § 494.170(a)(1) to
participation in network activities. In location. retain the existing § 405.2139(b) that
addition, we believe that this proposed • Requires facilities to maintain requires a facility to protect its patients’
condition pertains directly to the medical records in compliance with medical records against loss,
dialysis facility rather than the network State laws, or for 5 years in the absence destruction, or unauthorized use
and is a condition that a dialysis facility of State requirements. because the records are crucial to the
must meet in order to qualify for • Requires a facility to maintain patient’s care.
Medicare approval. adequate facilities, equipment, and However, we propose to eliminate the
space conveniently located, to provide requirement at § 405.2139(b) that the
D. Condition: Medical Records efficient processing, viewing, filing, and facility must have written policies and
(§ 494.170) prompt retrieval of medical records. procedures for recordkeeping. We
[If you choose to comment on issues in • Requires that a facility provide for believe this existing requirement is too
this section please include the caption the interchange of medical and other restrictive and inflexible. The facilities
‘‘Medical Records’’ at the beginning of information ‘‘necessary or useful’’ in the must protect medical record information
your comment.] care and treatment of patients and keep all patient records
transferred between treating facilities. confidential. Therefore, as long as there
The patient’s medical record presents In keeping with our goals to eliminate is a system in place to achieve the
a total picture of the care provided by unnecessary requirements and to reduce outcome, we believe that it is not
the dialysis facility. The medical burden on dialysis facilities, we are necessary to require the facility to have
record— retaining only those minimum facility written policies. However, facilities may
• Serves as an organized plan for requirements that we believe would be find it necessary to have written
treatment and is used for diagnosing, necessary in a patient outcome-oriented procedures to ensure that they achieve
treating, and caring for the patient; environment. the expected outcome.
• Facilitates communication among In the proposed medical records The existing requirement at
the various health care professionals condition for coverage (§ 494.170), we § 405.2139(b) mandates confidentiality
providing services to the patient; would state that the facility must in the handling of patient information
and requires facilities to safeguard We have mentioned Method II facility. We believe that it is essential to
patients’ records by making them specifically in this proposed the continuation of care that a patient’s
available only to authorized individuals. requirement because Method II requires medical history and plan of treatment
Under this requirement, a patient may that the patient’s ESRD facility is fully follow the patient. In addition, we are
refuse release of records to any aware of the equipment and supplies proposing to require that the facility
individual outside the facility, except in being used by the patient in order to exchange all medical records within 1
specific situations such as a patient’s accurately update the patient’s medical working day. The requirement that
transfer to another health facility or the record. Our new focus on achieving information be transferred within 1
release of information required by law. better patient outcomes is contingent working day is in existing
We are proposing in § 494.170(a)(2) upon accurate and current medical § 405.2137(b)(5) (Patient long-term
that the patient’s medical record be records for Method II and all other home program and patient care plan), which
released only under the following dialysis patients. states that if the patient is transferred to
circumstances: (1) The transfer of the In proposed § 494.170(c), we would another facility, the care plan is sent
dialysis patient to another facility; (2) make minor revisions to the existing with the patient or within 1 working
certain exceptions provided for in law; requirement at § 405.2139(e) that day of the transfer. However, we believe
(3) provisions allowed under a third medical records be retained for a period the requirement should apply not only
party payment contract; (4) approval by of time not less than that determined by to the care plan, but to any medical
the patient; or (5) inspection by State statute governing records retention record information, including, but not
authorized agents of the Secretary as or statute of limitations; or in the limited to, nutritional information,
required for the administration of the absence of a State statute, 5 years from social work services, and rehabilitation
Medicare program. the date of discharge; or, in the case of status.
We are proposing in § 494.170(a)(3) to a minor, 3 years or until the patient Because dialysis patients must receive
maintain the existing requirement at becomes of age under State law, frequent treatments at prescribed
§ 405.2139(b) that the facility obtain whichever is longer. The facility’s intervals, this proposed requirement
written authorization of the patient or policy for the retention and preservation would minimize disruption in care.
legal representative for release of of records must conform to the Without the medical information, the
information not required or authorized requirements of State law or regulations. patient might receive inappropriate
to be released by law. In this case, the date of discharge means
We are proposing in § 494.170(b)(1) to treatment. Requiring that the facility
the latest date the patient was transfer information within 1 working
retain the existing requirement at discharged from any type of service
§ 405.2139(d) that current medical day would minimize the possibility of a
provided by the dialysis facility.
records and those of discharged patients breakdown in communication between
As previously stated, existing
are completed promptly. In a dialysis § 405.2139(f) requires the dialysis facilities. It would also ensure that the
unit, it is essential that each clinical facility to maintain adequate facilities, patient continues to receive care in
event be documented as soon as equipment, and space conveniently accordance with his or her designed
possible after its occurrence. located, to provide efficient processing plan of treatment.
Documentation must be current so that of medical records (for example, Finally, we are proposing to eliminate
the medical records provide an up-to- reviewing, filing, and prompt retrieval) the requirement at existing § 405.2139(c)
date picture of the status of the patient and statistical medical information (for that the facility designate a staff member
at all times. We recognize that stating example, required abstracts, reports). to serve as the medical records
that medical records should be The rationale for this requirement was supervisor to facilitate the
completed promptly is somewhat vague that patient records should be easily recordkeeping process. The current
and subject to interpretation. We invite retrievable and available to all facility functions of the medical record
comments on the addition of a specific staff and that medical records of supervisor include, but are not limited
timeframe for the completion of patient patients undergoing treatment should be to: (1) Ensuring that the medical records
medical records. located close to the treatment area so are documented, completed, and
In proposed § 494.170(b)(2) we would that no time is lost in obtaining records maintained in accordance with accepted
maintain the existing requirement at for review and documentation. professional standards and practices; (2)
§ 405.2139(d) that all clinical Although we agree that patient medical safeguarding the confidentiality of the
information pertaining to a patient is records should be accessible, we do not records in accordance with established
centralized. Regardless of how the believe the prescriptive requirements in policy and legal requirements; (3)
medical record is completed and existing § 405.2139(f) are necessary. As ensuring that the records contain
maintained (on paper or electronically), a result, we are proposing to eliminate pertinent medical information and are
each member of the interdisciplinary this requirement. We believe that filed for easy retrieval; and (4) obtaining
team has access to the most recent facilities already provide easy access to the services of a qualified medical
information on the patient’s condition all patient medical records to ensure records practitioner when necessary. In
and prescribed treatment. that all staff can promptly retrieve and keeping with our goal of eliminating
We are also proposing, in review patient information. process requirements that are not
§ 494.170(b)(3), that the dialysis facility In § 494.170(d) we are proposing to predictive of good outcomes for patients
is responsible for completing, retain the requirement in existing or necessary to prevent harmful
maintaining and monitoring medical § 405.2139(g) that requires the facility to outcomes for patients, we are proposing
records for its Method II home dialysis provide for prompt transfer of medical to eliminate the requirement that a
patients and its other home patients. information between treatment facility designate a medical records
Under Method II, home dialysis patients facilities. The intent of this requirement supervisor.
elect to receive all equipment and is to facilitate continuation of care
E. Condition: Governance (Proposed
supplies from a DME company. The whenever a patient has to either
§ 494.180)
DME supplier must have a backup temporarily leave the facility (for
agreement with a dialysis facility that example, for vacation or hospitalization) [If you choose to comment on issues in
provides support services to the patient. or transfer permanently to a new this section please include the caption
‘‘Governance’’ at the beginning of your and maintaining written personnel Existing § 405.2136(h) requires the
comment.] manuals. governing body to designate a qualified
Existing § 405.2136(e) requires the physician as director of the ESRD
1. Existing Requirements for Governing
facility to develop detailed, written facility and establish written policies
Bodies
arrangements for the use of outside regarding how medical appointments
The existing requirements for the resources, as needed, through its CEO should be developed, maintained, and if
dialysis facility’s governing body are who will serve as a consultant with the necessary, terminated.
found at § 405.2136. Section 405.2136 responsibility to continually assess
states that the facility governing body or 2. Overview of the Proposed
performance and use documentation Governance Requirements
designated person(s) so functioning has (that is, dated, signed reports).
the full legal authority and Existing § 405.2136(f) specifies that Consistent with the shift from
responsibility for the governance and the ESRD facility must have written process-oriented requirements to a more
operation of the facility. The governing patient care policies, and that policies patient-centered, outcome-oriented
body adopts and enforces rules relative are— approach, we are proposing significant
to its own governance and to the health • Developed by the physician revisions to the governance condition.
and safety of patients, acts upon responsible for supervising or directing In developing these proposed revisions
recommendations from the Networks, the provision of ESRD services or the for the Governance condition we sought
and appoints a CEO who is responsible to identify requirements that are
facility’s organized medical staff (if
for the overall management of the covered in other parts of this proposed
there is one) with the advice of (and
facility. rule, as well as any other redundant,
with provision for review of such
Existing § 405.2136(a) covers the full unnecessary or overly burdensome
policies from time to time, but at least
disclosure of ownership for facilities requirements that are unrelated to better
annually, by) a group of professional
that are independently owned, patient outcomes. At the same time, we
personnel associated with the facility,
controlled by a partnership, or wholly want to retain those structural
including but not limited to, one or
or partially owned by corporate entities. requirements that might be indicative of
more physicians and one or more
Existing § 405.2136(b) requires the better patient outcomes or offer
registered nurses experienced in
governing body to develop, delineate, necessary protections to patient health
rendering ESRD care; and and safety. We also want to be
and review annually written operational • Approved by the governing body.
objectives for the facility. These responsive to a recommendation from
The governing body is also responsible the OIG (in its June 2000 report) to
objectives apply to, among other things, for periodic review of the
services provided and admission ‘‘strengthen the accountability of the
implementation of policies to ensure dialysis facility governing body’’
criteria. that the intent of the policies is carried
Existing § 405.2136(c) requires the (DHHS/OIG, June 2000). In that report,
out. the OIG made the following
appointment of a full-time or part-time
Under this section patient care recommendation: ‘‘The governing body
CEO who acts as the facility’s
policies must include the following: (1) should be held clearly accountable for
administrator. The CEO’s
Scope of services; (2) admission and the overall quality outcomes provided
responsibilities for the operation of the
discharge policies; (3) medical by the facility. Moreover, since most
facility include the following:
• Implementing facility policies. supervision and physician services; (4) dialysis facilities are now part of
• Coordinating administrative patient long-term programs and care national or multi-national corporations,
functions. plans; (5) medical and other the governing bodies should ensure that
• Authorizing expenditures. emergencies; (6) pharmaceutical authoritative representatives are readily
• Familiarizing staff with facility services; (7) medical records; (8) available to respond to queries and/or
policies, rules and regulations and administrative records; (9) maintenance visits by State survey agencies or
applicable Federal, State and local laws of the physical plant; (10) consultant Networks.’’ (DHHS/OIG, June 2000.)
and regulations. qualifications and activities; and (11) We believe that the performance of
• Maintaining and submitting home dialysis support services. This certain basic organizational functions is
required records and reports. standard also requires the medical a minimum condition for an
• Developing, negotiating and director to execute these patient care environment in which appropriate
implementing contracts. policies, schedule hours of operation patient-centered care can occur.
• Developing and implementing (when feasible) that are convenient to Therefore, the proposed Governance
accounting and reporting systems, an patients, and evaluate patients’ progress condition, § 494.180, requires the
annual budget, tracking expenses and toward goals in their long-term necessary minimum administrative
revenues, submitting reports; programs and care plans. features to allow the governing body to
• Ensuring the facility employs the Existing § 405.2136(g) requires the safely and effectively run a facility in an
necessary number of qualified governing body to ensure that every outcomes environment while being
personnel, that those personnel are patient is under the continuing care of responsive to the patients and to the
assigned appropriate duties, and have a physician and that a physician is OIG’s recommendation to strengthen the
opportunities for continuing education available in emergency situations. This accountability of the governing body.
and related developmental activities. standard requires the physician
Existing § 405.2136(d) requires the responsible for the patient’s care to 3. Governance Condition (Proposed
governing body, through the CEO, to evaluate the patient’s immediate and § 494.180)
develop and implement personnel long-term needs and prescribe a In proposed § 494.180 we state the
policies and procedures, covering, for planned regimen of care. The standard dialysis facility must be under the
example, assigned duties, health and also requires the governing body to control of an identifiable governing
safety hazards, supervising trainees, ensure that there is always medical care body, or designated person(s) so
maintaining personnel records for staff, available for emergencies with a list of functioning, with full legal authority
maintaining written personnel policies, physicians to contact posted at the and responsibility for the governance
orientation and in-service education, nursing/monitoring station. and operation of the facility. The
Medicare program requires that each patient ratios that are appropriate to the availability of support services. An
dialysis facility be independently level of dialysis care being given in acuity-based staffing plan, including
certified, and therefore, each facility order to meet the needs of its patients. some or all of the criteria listed above,
must independently achieve compliance The determination and allocation of could be developed by the nurse
with the conditions for coverage. It is appropriate staff-to-patient ratios is left responsible for nursing services in the
essential that surveyors and networks be to each dialysis facility. State agency facility and approved by the medical
able to identify the group or individual surveyors would assess facility director. It could also be incorporated
with legal responsibility and compliance with this requirement by into the facility’s QAPI program (see
accountability for managing patient evaluating whether routine care is being § 494.110) as a means of achieving
health care, safety, and protection of delivered, assessments are conducted as desired outcomes of care specified in
patient rights and for the operation of the patient’s condition changes, routine the facility’s individual patient plans of
each dialysis facility. monitoring adheres to facility policy, care (see § 494.90). We are soliciting
and patients care provided by staff public comment on whether we should
4. Designating of a Chief Executive
during surveys (for example, equipment include a requirement for an acuity-
Officer or Administrator (Proposed
alarms are responded to promptly). In based staffing plan in § 494.180(b)(1) to
§ 494.180(a))
our deliberations regarding ‘‘adequate ensure that every dialysis facility has
Proposed § 494.180(a) retains the staff’’, we noted that there is no national ‘‘adequate staffing’’ and appropriate
existing requirement for the governing consensus within the dialysis industry staff-to-patient ratios to meet the needs
body or responsible party(ies) to appoint regarding the appropriate staff-to-patient of its patients.
an individual who will serve as the ratios. We also noted the wide variety of We are proposing in § 494.180(b)(2)
facility’s CEO or administrator. We are State staff-to-patient ratio requirements. that a registered nurse must be present
proposing to use these terms For example, some States have staff-to- in the facility at all times that patients
interchangably (that is, CEO and patient ratio requirements for registered are being treated. We have made this
administrator) because the duties would nurses. Connecticut requires that 50 proposal for several reasons. As
be the same regardless of the title percent of a dialysis unit’s patient care previously discussed in this preamble,
assigned. We have previously proposed staff be registered nurses. New Jersey the rapidly changing demographics of
that the facility’s medical director (see requires a registered nurse for the first the dialysis patient population has
§ 494.150) assume certain clinical nine patients in the unit. Georgia and resulted in an older, sicker patient
responsibilities for the care provided South Carolina mandate a registered population. An older patient population
within the unit. We recognize that in nurse for every 10 patients, while Texas with more serious co-morbid conditions
smaller units it would be possible for requires a registered nurse for every 12 elevates the potential for medical
the same individual to perform the patients. Washington requires two emergencies (for example, heart attack,
duties of both medical director and registered nurses per shift. Oregon stroke, severe reactions to chemicals). A
CEO/administrator and these requires that a written staff plan for registered nurse has the professional
regulations do not preclude that. registered nurses be on file with the training and expertise to properly react
However, in a typical unit we believe State. to these types of emergencies. Properly
the volume, scope, and complexity of Some States have staff-to-patient trained dialysis technicians and
administrative, financial, and ratios for patient care technicians. licensed practical nurses may be
operational responsibilities requires the Maryland, Massachusetts, New Jersey, effective in providing day-to-day patient
day-to-day attention of a separate CEO/ Washington, Puerto Rico, and the Virgin care, but may lack the training and
administrator position. Therefore, we Islands require a three-to-one patient-to- expertise to react to critical medical
are proposing to retain this position and staff care technician ratio. Georgia, emergencies. Therefore, we believe that
the performance of certain duties and South Carolina, and Texas require a having a registered nurse on the
responsibilities by the occupant of this four-to-one patient-to-patient care premises when treatment is being
position in these proposed conditions. technician ratio. Nevada has a 100 to 1 provided is a necessary health and
We are proposing in § 494.180(a) that patient-to-staff ratio for social workers safety measure for dialysis patients.
the CEO/administrator exercise overall and renal dietitians. Further Registered nurses, by training and
management responsibility for the complicating the wide variation in State professional expertise, are also needed
facility and oversee staff appointments, regulations are decisions involving to provide other important patient care
fiscal operations, the relationship with scope of practice and the various nurse functions that occur routinely while
the ESRD network, and the allocation of practice acts administered by the State patients are being dialyzed. Those
necessary staff and other resources for boards of nursing. For the reasons cited functions include: (1) Assessing patient
the facility’s QAPI program (see above, we are not proposing any Federal needs; (2) developing treatment plans;
§ 494.110). staff-to-patient ratios. (3) coordinating ongoing care in the
However, we are interested in unit; (4) continually evaluating the
5. Adequate Number of Qualified and strengthening the existing requirement ability of the other nursing and
Trained Staff (§ 494.180(b)) while at the same time preserving the technical staff to use the most current
Proposed § 494.180(b) would retain facility’s flexibility in determining the skills and techniques; (5) answering
and consolidate some of the existing appropriate staff-to-patient ratio. clinical questions from patients and
requirements at §§ 405.2136(c)(3)(viii) One alternative to mandated staff-to- staff; (6) and providing direct
and 405.2162(b)(2). patient ratios is an acuity-based staffing supervision for dialysis technicians
We propose at § 494.180(b)(1) to system developed by each dialysis during their 3-month training period
retain the existing requirement at facility. This type of system would take (see proposed § 494.140(e)(3)).
§ 405.2162(b)(2) that a dialysis facility into account the number of patients At § 494.180(b)(3), we are proposing
ensure an adequate number of qualified treated on each shift, individual patient to retain the existing requirement that
personnel are present whenever patients characteristics, patient needs, the all employees have appropriate
are undergoing dialysis. Under the expertise and experience levels of orientation to the facility and their work
existing requirement, every approved facility staff, the physical layout of the responsibilities upon employment. In
dialysis facility must maintain staff-to- facility, available technology, and the addition, at § 494.180(b)(4), we are
proposing to retain the existing medical staff). Consistent with the new be designed to ensure that no patient,
requirement that all employees have an patient outcomes in this regulation, we including disruptive or noncompliant
opportunity for continuing education are proposing to add a new requirement patients, is discharged or transferred
and related development activities. at § 494.180(c)(2) that the governing from the facility unless one of the
At § 494.180(b)(5), we are proposing a body be responsible for ensuring that all following situations applies:
new requirement for a written approved attending physicians, physicians • The patient or payor will no longer
training program, designed by the assistants, and nurse practitioners who reimburse the facility for covered
facilities, that is specific to dialysis provide care in the facility are informed services;
technicians. As discussed earlier in this regarding all patient care policies and • The facility ceases to operate;
preamble, dialysis technicians are now procedures as well as the QAPI • The transfer is necessary for the
the primary caregivers in many dialysis program. We believe adding this new patient’s welfare because the facility can
units, and we have proposed minimum requirement will assist the facility no longer meet the patient’s
Federal requirements for this medical director in achieving better documented medical needs;
occupation because we believe properly patient outcomes through direct care • The facility has determined the
trained dialysis technicians are essential and through the QAPI program without patient’s behavior is so disruptive or
in achieving good patient outcomes of adding any unnecessary burden to a abusive that the facility is unable to
care (see § 494.140(e)). Many States that dialysis facility. We are soliciting deliver care to the patient or to operate
regulate dialysis technicians require comments on our proposal to delete effectively.
training programs that include: (1) The process requirements for medical staff We are proposing that the governing
initiation of dialysis; (2) monitoring and appointments and add a new governing body assign the medical director the
termination of dialysis; (3) possible body requirement to inform the facility’s responsibility to monitor and review
complications of dialysis; (4) water medical staff regarding the facility’s every patient discharge of an abusive or
treatment; and (5) infection control patient care policies and the facility’s disruptive patient to ensure that the
procedures. quality assurance and performance patient’s interdisciplinary team has
We are proposing that every dialysis improvement program. reassessed the patient and documented
patient care technician-training program the ongoing problem(s) and efforts to
contain criteria that would provide at 7. Furnishing Services (Proposed resolve the problem(s); obtained a
least a minimal set of skills. When State § 494.180(d)) written physician’s order which must be
requirements meet or exceed these Proposed § 494.180(d) would retain signed by the medical director and (if
proposed patient care technician- the existing requirement § 405.2102 for applicable) the patient’s attending
training requirements, the State the governing body to ensure that physician; and that a documented
requirements would have to be met. The (except for home care services provided attempt has been made to place the
criteria we are proposing include the pursuant to § 494.100) services are patient in another facility. The State
following competencies: (1) Principles furnished directly (see § 494.10) on its survey agency and the ESRD network
of dialysis; (2) care of the patient with main premises or on other premises that must be notified of the involuntary
kidney failure, including interpersonal are contiguous with the main premises discharge of any patient. We believe, as
skills; (3) dialysis procedures and under the direction of the same the individual in charge of patient care
documentation, including initiation, professional staff and governing body as in the facility, the medical director (see
monitoring, and termination of dialysis; the main premises. We believe this proposed § 494.150(c)(2)(ii)) is the
(4) possible complications of dialysis; requirement is essential to ensure that appropriate individual to ensure that a
(5) water treatment; (6) infection dialysis services are not provided in patient’s interdisciplinary team has
control; (7) safety; and (8) dialyzer uncertified locations. followed the procedure described in
reprocessing, if applicable. We invite § 494.180(f) before any transfers or
public comment on the basic criteria 8. Internal Grievance Process (Proposed discharges from the facility. We also
proposed for § 494.180(b)(5)(i) through § 494.180(e)) believe it is important to allow facilities
(viii). In § 494.180(e), we are proposing to the flexibility to make these
require that facilities have an internal determinations on a case-by-case basis
6. Medical Staff Appointments
grievance process. We believe a good without the imposition of prescriptive
(Proposed § 494.180(c))
internal grievance process is an criteria that would define disruptive or
In § 494.180(c) we propose to retain invaluable tool in resolving patient abusive behavior. However, the facility’s
some of the existing requirements at grievances in a positive and expeditious interventions and reasons for
§ 405.2136(h) that the governing body be manner for both the patient and the involuntary discharge of a disruptive or
responsible to oversee appointments to facility. The grievance process must abusive patient must be clearly
medical staff. We propose to expand include a clearly explained procedure documented in the patient’s medical
this requirement to include all medical for the submission of grievances, record. We invite comments on our
staff appointments, including timeframes for reviewing the grievance, proposal to hold the dialysis facility
appointments and credentialing for and a description of how the patient or accountable for their staff adherence to
attending physicians, physician the patient’s designated representative facility’s patient discharge or transfer
assistants, and nurse practitioners. will be informed of steps taken to policies and procedures.
However, consistent with our goal to resolve the grievance. The grievance
reduce unnecessary process-oriented 10. Emergency Coverage (Proposed
process must be implemented so that
requirements and regulatory burden, we § 494.180(g)
the patient may file a grievance with the
are not proposing to retain the existing facility without reprisal or denial of Proposed § 494.180(g) would require
requirement in § 405.2136(h) for the services. the governing body to be responsible for
governing body to establish written emergency coverage. Emergency
policies regarding the development, 9. Discharge and Transfer Policies and coverage is not the same thing as
negotiation, consummation, evaluation, Procedures (Proposed § 494.180(f)) emergency preparedness (see
and termination of appointments to the We are also proposing that the § 494.60(d) in the proposed physical
medical staff (if the facility has a facility’s discharge and transfer policy environment condition). As previously
discussed, emergency preparedness hospital that can provide inpatient care, also discussed in section II.E.3 and 4 of
applies to medical and nonmedical other hospital services, and emergency this preamble.
emergencies related to fire, equipment services which are available 24 hours a Dialysis facilities and ESRD networks
or power failures, care-related day, 7 days a week; services will be have used the ESRD CPM project annual
emergencies, water supply made available promptly; and there are reports for benchmarking purposes and
interruptions, and natural disasters. The reasonable assurances in the agreement as a means of identifying opportunities
emphasis in emergency preparedness is that patients from the dialysis facility to improve care. The approach of this
on the facility staff’s ability to manage will be accepted and treated in proposed rule is to decrease process
and respond appropriately to these emergencies. This is consistent with our requirements and instead look to
facility-wide problems. Emergency goal of transitioning from unnecessary outcomes of patient care so that quality
coverage, as proposed in § 494.180(g), procedural and process requirements to may be assessed and reported. The
relates only to patient medical a patient-outcomes environment in CPMs will be a part of the vehicle by
emergencies. Specifically, proposed which a dialysis facility will have more which we measure and report on the
§ 494.180(g)(1) would require the flexibility in determining how necessary quality of dialysis services provided in
governing body to ensure that patients services, including emergency services, the Medicare program.
and staff have written instructions for are provided to its patients. The CPM data collection tools were
obtaining emergency medical care. We briefly described in section II.E.5 of this
11. Furnishing Data and Information for preamble. Data elements included on
believe giving patients and staff written
ESRD Program Administration these forms are intermediate outcome
instructions is both prudent and
(Proposed § 494.180(h) measures and process markers for
necessary to ensure that every patient
has the necessary information if and We propose in § 494.180(h) that adequacy of hemodialysis and
when a medical emergency should arise. dialysis facilities furnish data and peritoneal dialysis, anemia
Proposed § 494.180(g)(2) would retain information electronically and in management, nutrition (albumin), and
the existing provision at § 405.2136(g)(2) intervals that conform to specifications vascular access management.
that requires the dialysis facility to post, established by the Secretary. While The CMS VISION software will
at the nursing/monitoring station, a reporting data and information is an provide the electronic means for
roster of physician names to be called existing requirement in § 405.2133, the collection of the ESRD administrative
for emergencies, when they can be proposal to require the ESRD CPM data forms (that is, CMS–2728, CMS–2746,
reached, and how they can be reached. and to require electronic data reporting and CMS–2744) as well as the CPM data
Proposed § 494.180(g)(3) retains and are new requirements. The CPM project, (CMS–820 and CMS–821). In the future,
combines existing provision at a quality improvement initiative CMS VISION software may also collect
§ 405.2136(g)(2) which requires the between CMS, the ESRD networks, and other information such as patient
governing body to ensure emergency ESRD facilities was discussed in section experience of care survey data. The
care is always available, and existing II.E.4.1 of this proposed rule. Currently, VISION program will utilize an
§ 405.2160 which requires the facility to dialysis facilities participate in this encryption technology that assures
have an agreement with a hospital to project voluntarily. We are proposing privacy, confidentiality, and security for
provide inpatient care and other full participation in reporting the electronic communications. The
services to patients at all times. existing CPMs by all dialysis facilities. requirement for full CPM reporting on
However, our proposed agreement We have received recommendations all patients by all facilities will be
requirement at § 494.180(g)(3) is much from the OIG ‘‘External Quality Review implemented only when the VISION
less prescriptive than the existing of Dialysis Facilities/A Call For Greater software is fully operational. Vision
requirement at § 405.2160, which is a Accountability,’’ the IOM ‘‘Crossing the software will be provided to
condition-level requirement. For Quality Chasm, 2001’’, and Medicare independent dialysis facilities and small
example, § 405.2160 requires a dialysis Payment Advisory Commission to medium size corporate dialysis
facility to have an agreement with a (MedPAC) ‘‘Improving Quality facilities at no cost. Specifications are
renal dialysis center, which is defined Assurance for Institutional Providers’’ to being provided for developing an
in existing § 405.2102 as a hospital that require facilities participating in interface between the major corporate
is qualified to provide the full spectrum Medicare to report on performance dialysis facilities’ databases and the
of diagnostic, therapeutic, and measures to stimulate improvements in CMS database to enable ESRD
rehabilitative services required for the the quality of care and to achieve a administrative data and CPM data to be
care of ESRD dialysis patients. Existing degree of accountability for performance transmitted electronically with minimal
§ 405.2160 also contains explicit ((DHHS/OIG, 1999), (IOM, 2001), and effort from dialysis facility staff. There
requirements for the affiliation (MedPAC, 2000) respectively). The are initial costs for major corporate
agreement, that is, the agreement must requirement for full CPM reporting is an dialysis facilities as they develop the
(1) include the basis for working important step in moving in that software interface and for initial
relationships between staff of both direction. training. For a more detailed discussion
facilities to ensure that services are Section 4558(b) of Pub. L. 105–33 of these costs see section IX. of this
available promptly; (2) specify transfers requires us to develop a method to preamble.
for only medically appropriate measure and report the quality of The Secretary will determine the
circumstances as determined by the dialysis services provided in the frequency of CPM data collection.
medical director or attending physician; Medicare program. To comply with this Facilities currently report (via billing
(3) prescribe an interchange (within 1 requirement, we developed the CPMs submissions) monthly URR values for
working day) between facilities of the from the NKF–DOQI (now NKF–K/ all hemodialysis patients and monthly
patient’s long-term plan and patient care DOQI) clinical practice guidelines. The hematocrit levels for all patients
plans; and (4) specify security and CPM project assists providers in the receiving erythropoietin.
accountability for patients’ personal assessment of care provided to ESRD The CPM data collection would
effects. Our proposal, at § 494.180(g)(3) patients and stimulates improvement in provide a means for the reporting of
states simply that the dialysis facility that care. The processes used to develop facility-specific performance measures
must have an arrangement with a the CPMs and the DOQI guidelines were capturing information related to the
quality of care delivered. This kind of This proposal, which requires CPM website provides detailed information
information is especially important if a reporting, is specific to the CPMs as about Medicare-certified dialysis
fully-bundled payment system for the they currently exist. The process for facilities and allows for comparison of
ESRD program expands the composite updating, revising, and expanding the facility characteristics and quality
rate structure to include all outpatient CPMs will be done in conjunction with measures. We are evaluating the
routine dialysis payments. We are the NTTAA process. A voluntary information reported on the Dialysis
concerned that this change in the consensus standards body, which as yet Facility Compare website for usability
payment structure could provide has not been identified, would likely and to ensure that the publicly reported
financial incentives to reduce services plan, develop, establish, or coordinate information meets the needs of the
provided to ESRD beneficiaries; thereby voluntary consensus standards using beneficiary. The availability of
compromising quality of care. Any shift agreed upon procedures in conjunction information will permit patients to
in payment policy necessitates a strong with the NTTAA. become more active participants in their
external monitoring process to ensure In the February 19, 1998 Federal facilities’ quality improvement process.
that an acceptable level of care Register (63 FR 8546), the Office of Informed patients make better health
continues. The reporting of facility- Management and Budget published a care choices and are more active
specific performance measures and the notice regarding the Federal participants in their medical care.
development of standards would participation in the development and 12. Disclosure of Ownership (Proposed
provide us with the means externally to use of voluntary consensus standards. § 494.180(i))
evaluate and monitor dialysis facilities We will use the policies established in
to ensure that the necessary services this publication and the Administrative In § 494.180(i) we are proposing to
have been provided and to assist Procedure Act (APA) when adopting retain the existing § 405.2136(a) that the
patients to reach optimal outcomes. voluntary consensus standards. If we dialysis facility must provide complete
We are looking at the feasibility of adopt voluntary consensus standards information to the State survey agency
developing minimum performance that are not legally binding, we would regarding persons who have any direct
standards. There are widely accepted publish them as a notice in the Federal or indirect ownership of the facility in
(K/DOQI) clinical practice guidelines Register. whole or in part in compliance with the
and clinical performance measures The ESRD CPM project data, which requirements of §§ 420.200 through
(CPMs) in existence. However, there is would provide the use patterns of 100 420.406. This requirement, reporting
no consensus for minimum performance percent of dialysis patients, would ownership interests of 5 percent or
standards. Dialysis facility performance provide an array of possibilities for more, is a conforming change to
is generally compared to performance of facilities to compare performance and comport with the existing requirements
other facilities in the network or to practice patterns at facility, State, in § 420.201, which have been in effect
national performance data. Facilities network, and national levels in order to since 1992.
whose performance measures fall well identify opportunities for improvement VII. Other Proposed Changes and Issues
below the comparison group are in the care of dialysis patients.
generally identified as needing This information would provide A. Proposed Cross-Reference Changes
improvement. However, we do not have independent dialysis facilities with the [If you choose to comment on issues in
defined thresholds that tell us, for same type of information that some this section please include the caption
example, that if a dialysis facility dialysis chain corporations have been ‘‘Cross-Reference Changes’’ at the
provided a KT/V of 1.2 or higher to at able to collect on their own dialysis beginning of your comment.]
least 85 percent of its hemodialysis facilities across the nation. These CPM We are proposing to make technical
patients, that facility is providing an data would expand the breadth of data changes in the following sections of the
acceptable level of care. that have been previously available even regulations to correct cross-references to
An additional problem in using to the large dialysis corporations. the sections in part 405, subpart U that
minimum standards for accountability The ESRD networks would use the are proposed to be relocated or deleted:
purposes is the possibility of ‘‘cherry CPM data elements and calculated §§ 410.5, 410.50, 410.52, 410.152,
picking’’ and decreased access to measures in order to assist dialysis 410.170, 413.170, 413.172, 413.198, and
dialysis for some patients. Dialysis facilities with quality improvement 414.330.
facilities may have a disincentive to activities and as a benchmark to look at
accept patients likely to be more B. Proposed Additions to Part 488
their own performance.
difficult to manage as well as patients The State survey agencies would [If you choose to comment on issues in
that are more resource-intensive and receive facility profiles as well as data this section please include the caption
who are less likely to achieve acceptable for dialysis adequacy, vascular access, ‘‘Part 488’’ at the beginning of your
levels on the performance measures. anemia management, and nutrition for comment.]
This raises the issue of the necessity of use in their survey activities. We are proposing to add a new
risk adjusters to be used in developing At a minimum, we would use the subpart H to part 488. Proposed subpart
the bundled payment rate, as well as following facility-specific information H would consist of the existing sanction
developing performance standards for for public reporting on our Dialysis provisions in part 405 subpart U. The
accountability. We are looking at these Facility Compare Web site: existing sanction provisions are in
difficult issues and considering the • Number of patients included in §§ 405.2180, 405.2181, 405.2182, and
implications of any changes in payment each calculation. 405.2184 and are summarized as
and performance accountability. We are • Percent of patients treated in the follows:
soliciting comments on how the facility with a Kt/V ≥ 1.2. • Section 405.2180 specifies the basic
incentives to ‘‘cherry pick’’ could be • Percent of patients treated in the sanction, which is termination of
minimized. Any performance standards facility with a hemoglobin ≥ 11 gms/dL. Medicare coverage, and the basis for
that we may use for dialysis facilities Public reporting of performance reinstatement of coverage after
would be developed in conjunction measures provides an important termination.
with the NTTAA process discussed in resource to dialysis patients and their • Section 405.2181 specifies the
section II.E.6 of this preamble. families. The Dialysis Facility Compare alternative sanctions denial of payment
of any patients accepted for care after • Section 405.2184 specifies (in VIII. Reference Materials
the effective date of the sanction, and greater detail) the rights of suppliers
A. New Provisions of Part 494
gradual reduction of payments for all that appeal proposed imposition of an
patients) and the circumstances under alternative sanction. This proposed rule contains a number
which they might be imposed. We propose to redesignate these of requirements that are not included in
• Section 405.2182 specifies the provisions (with technical and cross- the existing regulations. For information
notice procedures that we will follow reference changes) as §§ 488.604, and ease of reference, outlined below is
and the appeal rights of sanctioned 488.606, 488.608, and 488.610 a list of the new provisions, grouped by
suppliers. respectively. condition:
Condition New provisions
Infection control (§ 494.30) .................................. § 494.30(a)—Infection control procedures (including the Recommended Infection Control Prac-
tices for Hemodialysis Units At a Glance CDC guidelines).
§ 494.30(a)(2)—Patient isolation procedures.
Water quality (§ 494.40) ...................................... § 494.40—Incorporates by reference the updated 2001 American National Standard/Associa-
tion for the Advancement of Medical Instrumentation guidelines for water purity.
Physical environment (§ 494.60) ......................... § 494.60(e)—Fire safety.
Patient rights (§ 494.70) ...................................... § 494.70(a)(5)—Advance directives.
§ 494.70(a)(14)—Complaint systems.
§ 494.70(b)—Discharge and transfer policies.
§ 494.70(d)—Posting of rights.
Patient assessment (§ 494.80) ............................ § 494.80(a)(2)—Appropriateness of dialysis prescription.
§ 494.80(a)(5)—Renal bone disease.
§ 494.80(a)(8)—Dialysis access type and maintenance.
§ 494.80(a)(10)—Suitability for transplantation referral, including basis for referral or non-
referral.
§ 494.80(b)—Frequency of assessment.
§ 494.80(c)—Assessment of treatment prescription.
§ 494.80(d)—Patient reassessment.
Patient plan of care (§ 494.90) ............................ § 494.90(a)(1)—Dose of dialysis.
§ 494.90(a)(2)—Nutritional status.
§ 494.90(a)(3)—Anemia.
§ 494.90(a)(4)—Vascular access.
§ 494.90(a)(5)—Transplantation status.
§ 494.90(a)(7)—Rehabilitation status.
§ 494.90(b)—Implementation of patient plan of care.
§ 494.90(b)(3)—Direct physician/patient interaction.
§ 494.90(c)—Transplantation referral tracking.
Care at home (§ 494.100) ................................... § 494.100(a)—Training.
§ 494.100(b)—Home dialysis monitoring.
§ 494.100(c)—Support services.
Quality assessment and performance improve- § 494.110(a)—Program scope.
ment (§ 494.110). § 494.110(a)(2)(i)—Adequacy of dialysis.
§ 494.110(a)(2)(ii)—Nutritional status.
§ 494.110(a)(2)(iii)—Anemia management.
§ 494.110(a)(2)(iv)—Vascular access.
§ 494.110(a)(2)(v)—Medical injuries and medical error identification.
§ 494.110(a)(2)(vi)—Hemodialyzer reuse.
§ 494.110(a)(vii)—Patient satisfaction.
§ 494.110(b)—Monitoring performance improvement.
§ 494.110(c)—Prioritizing improvement activities.
Special purpose renal dialysis facilities (§ 494.120)—Definition.
(§ 494.120).
Personnel qualifications (§ 494.140) ................... § 494.140(b)—Nursing services.
§ 494.140(e)—Dialysis technicians.
Responsibilities of the medical director § 494.150(a)—Quality assessment and performance improvement program.
(§ 494.150).
§ 494.150(b)—Staff education, training, and performance.
§ 494.150(c)—Patient care policies and procedures.
Governance (§ 494.180) ...................................... § 494.180(c)—Medical staff appointments.
§ 494.180(d)—Furnishing services.
§ 494.180(e)—Internal grievance process.
§ 494.180(f)—Discharge and transfer policies and procedures.
§ 494.180(g)—Emergency coverage.
§ 494.180(h)—Furnishing data and information for ESRD program administration.
B. ESRD Crosswalk (Cross Refers

Existing Requirements to Proposed
Requirements)
Proposed conditions (part

Existing conditions (part 405, subpart U) Existing citation Proposed citation
494)
Scope of subpart ............................................................. 405.2100(a) ....................... Basis and scope ................ 494.1
405.2100(b) ....................... Deleted.
Objectives of ESRD program .......................................... 405.2101 ............................ Deleted.
Definitions ........................................................................ 405.2102 ............................ Definitions .......................... 494.10
Agreement ................................................................ ............................................ Deleted ..............................
Arrangement ............................................................. ............................................ Deleted ..............................
Dialysis ..................................................................... ............................................ Deleted ..............................
End-stage renal disease .......................................... ............................................ Deleted .............................. 406.13(b)
ESRD facility (introductory text) ............................... ............................................ ............................................
(a) Renal transplantation center ....................... ............................................ Retained in 405, Subpart U 494.10
(b) Renal dialysis center ................................... ............................................ Deleted ..............................
(c) Renal dialysis facility ................................... ............................................ Definitions .......................... 494.10
(d) Self-dialysis unit ........................................... ............................................ Deleted ..............................
(e) Special purpose renal dialysis facility ......... ............................................ Special purpose renal di- 494.120
alysis facilities.
ESRD service (introductory text) .............................. ............................................ Retained in 405, Subpart U
(a) Transplantation service ............................... ............................................ Deleted ..............................
(b) Dialysis service ............................................ ............................................ Deleted ..............................
(1) Inpatient dialysis ................................... ............................................ Deleted ..............................
(2) Outpatient dialysis ................................ ............................................ Deleted ..............................
(i) Staff-assisted dialysis ..................... ............................................ Definitions ..........................
(ii) Self-dialysis .................................... ............................................ Deleted .............................. 494.10
(3) Home dialysis ....................................... ............................................ Care at home ....................
(c) Self-dialysis and home dialysis ................... ............................................ Deleted .............................. 494.100
Furnishes directly ..................................................... ............................................ Governance .......................
Furnishes on the premises ....................................... ............................................ Retained in 405, Subpart U 494.180(d)
Histocompatibility testing .......................................... ............................................ Deleted ..............................
Medical care criteria ................................................. ............................................ Deleted ..............................
Medical care norms .................................................. ............................................ Deleted ..............................
Medical care standards ............................................ ............................................ Deleted ..............................
Medical care evaluation study .................................. ............................................ Deleted ..............................
Network ESRD ......................................................... ............................................ Retained in 405, Subpart U
Network organization ................................................ ............................................ Retained in 405, Subpart U
Organ procurement (introductory text) ..................... ............................................ Deleted ..............................
Governance .......................
(a) Chief executive officer ................................. ............................................ Personnel qualifications .... 494.190(a)
(b) Dietitian ........................................................ ............................................ Deleted .............................. 494.150(c)
(c) Medical record practitioner .......................... ............................................ Personnel qualifications ....
(d) Nurse responsible for nursing services ....... ............................................ Personnel qualifications .... 494.150(b)
(e) Physician-director ........................................ ............................................ Personnel qualifications .... 494.150(a)
(f) Social worker ................................................ ............................................ Retained in 405, Subpart U 494.150(d)
(g) Transplantation surgeon .............................. ............................................ ............................................
Designation of ESRD networks ....................................... 405.2110 ............................ Retained in 405, Subpart U
[Reserved] ....................................................................... 405.2111 ............................ Deleted ..............................
ESRD network organizations .......................................... 405.2112 ............................ Retained in 405, Subpart U
Medical review board ...................................................... 405.2113 ............................ Retained in 405, Subpart U
Minimum utilization rates: General .................................. 405.2120 ............................ Retained in Subpart U .......
Basis for determining minimum utilization rates ............. 405.2121 ............................ Retained in Subpart U .......
Types and duration of classification according to utiliza- 405.2122 ............................ Retained in Subpart U .......
tion rates.
Reporting of utilization rates for classification ................. 405.2123 ............................ Retained in Subpart U .......
Calculation of utilization rates for comparison with min- 405.2124 ............................ Retained in Subpart U .......
imum utilization rate(s) and notification of status.
Minimum utilization rates ................................................. 405.2130 ............................ Retained in Subpart U .......
Provider status: renal transplantation center or renal di- 405.2131 ............................ Retained in 405, Subpart U
alysis center.
Furnishing data and information for ESRD program ad- 405.2133 ............................ Governance ....................... 494.190(f)
ministration.
Participation in network activities .................................... 405.2134 ............................ Relationship with ESRD 494.170
network.
Compliance with Federal, State, and local laws and reg- 405.2135 ............................ Compliance with Federal, 494.20
ulations. State, and local laws
and regulations.
Governing body and management .................................. 405.2136 ............................ Governance ....................... 494.180 (introductory text)
(a) Disclosure of ownership ..................................... 405.2136(a) ....................... Governance ....................... 494.180(g)
(b) Operational objectives ........................................ 405.2136(b) ....................... Deleted ..............................
(c) Chief executive officer ........................................ 405.2136(c) ....................... Governance ....................... 494.180(a)
(d) Personnel policies and procedures .................... 405.2136(d)(1,3–5,7) ......... Deleted ..............................
(d)(2) Infection control/Incident reports .................... 405.2136(d)(2) ................... Infection control and Qual- 494.30(a) & 494.110(a)(5)
ity assessment and per-
formance improvement.

494)
(d)(6) Facility personnel educational programs ....... 405.2136(d)(6) ................... Personnel qualifications .... 494.140(e)
(e) Use of outside resources .................................... ............................................ Medical Director ................ 494.150(c)
(f) Patient care policies ............................................ 405.2136(e) ....................... Deleted ..............................
(g) Medical supervision and emergency coverage .. 405.2136(f) ........................ Medical Director ................ 494.150(d)
405.2136(g)(1) ................... Patient plan of care ........... 494.90 (introductory text)
(h) Medical staff ........................................................ ............................................ Care at home and Govern- 494.100(c) & 494.180(b)
ance.
494.2136(g)(2) ................... Governance ....................... 494.180(e)
405.2136(h) ....................... Governance ....................... 494.180(c)
Patient long-term program and patient care plan ........... 405.2137 (introductory Patient care plan ............... 494.90 (introductory text)
text).
(a) Patient long-term program .................................. 405.2137(a) ....................... Deleted ..............................
(b) Patient care plan ................................................. 405.2137(b) ....................... Patient care plan ............... 494.90 (introductory text)
(b)(1) Personalized care plan ................................... 405.2137(b)(1) ................... Patient care plan ............... 494.90 (introductory text)
(b)(2) Developed by a professional team ................ 405.2137(b)(2) ................... Patient care plan ............... 494.90 (introductory text)
(b)(3) The patient is involved ................................... 405.2137(b)(3) ................... Patient rights ..................... 494.70(a)(5)
(b)(4) Frequency of care plan review ....................... 405.2137(b)(4) ................... Patient plan of care ........... 494.90(b), (1)
(b)(5) Transfer of care plan ...................................... 405.2137(b)(5) ................... Medical records ................. 494.170(d)
(b)(6) Care plan for the home dialysis patient ......... 405.2137(b)(6) ................... Care at home .................... 494.100 (introductory text)
(b)(7) Erythropoietin for the home dialysis patient ... 405.2137(b)(7) ................... Patient plan of care ........... 494.90(a)(3)
Patient’s rights and responsibilities ................................. 405.2138(a)–(d) ................. Patient rights and medical 494.70(a) and 494.170(a)
records.
405.2138(e) ....................... Patient rights ..................... 494.70(c) (13 and 14)
Medical records ............................................................... 405.2139 ............................ Recordkeeping .................. 494.170 (introductory text)
(a) Medical record contents ..................................... 405.2139(a) ....................... Deleted ..............................
(b) Protection of medical record information ............ 405.2139(b) ....................... Recordkeeping .................. 494.170(a)
(c) Medical record supervisor ................................... 405.2139(c) ....................... Deleted ..............................
(d) Completion and centralization ............................ 405.2139(d) ....................... Recordkeeping .................. 494.170(b)
(e) Retention and preservation ................................ 405.2139(e) ....................... Recordkeeping .................. 494.170(c)
(f) Location and facilities .......................................... 405.2139(f) ........................ Deleted ..............................
(g) Transfer of medical information .......................... 405.2139(g) ....................... Recordkeeping .................. 494.170(d)
Physical environment ...................................................... 405.2140(a) (introductory Physical environment ........ 494.60 (introductory text)
text).
(a) Building and equipment ...................................... 405.2140(a)(1) ................... ............................................
(a)(1) Fire ................................................................. 405.2140(a)(2), (3) ............ Physical environment ........ 494.60(e)
(a)(2), (3) Equipment and areas are hazard free .... ............................................ Physical environment ........ 494.60(a), (b)
(a)(5) Water quality requirements ............................ 405.2140(a)(5) ................... ............................................
(b) Favorable environment for patients .................... 405.2140(b) (introductory Water quality ..................... 494.40
text).
(b)(1) Infection prevention ........................................ ............................................ Physical environment ........ 494.60(c)
(b)(2)(4) Adequate treatment areas/Heating and 405.2140(b)(1) ................... Infection control ................. 494.60(c)
ventilation systems. 405.2140(b)(2)(4) .............. Physical environment ........ 494.60(c)
(b)(3) Nursing station ............................................... ............................................ ............................................
(b)(5) Special dialysis solutions ............................... 405.2140(b)(3) ................... Deleted ..............................
(c) Contamination prevention ................................... 405.2140(b)(5) ................... Deleted ..............................
405.2140(c) ....................... Infection control and 494.30(a) and 494.40
Reuse of.
(d) Emergency preparedness ................................... 405.2140(d) ....................... Hemodialyzers ................... (introductory text), (a)
Physical environment ........ 494.60(d)
Reuse of hemodialyzers and other dialysis supplies ...... 405.2150 (introductory Reuse of hemodialyzers 494.50 (introduction)
text). and Bloodlines.
(a) Hemodialyzers .................................................... 405.2150(a)(1–3) ............... Reuse of hemodialyzers 494.50 (introduction), (a),
and Bloodlines. (b)
(b) Transducer filters ................................................ 405.2150(b) ....................... Infection Control ................ 494.30(a)(1)
(c) Bloodlines ............................................................ 405.2150(c) ....................... Resuse of hemodialyzers 494.50(c)
and Bloodlines.
Affiliation agreement or arrangement .............................. 405.2160 (a), (b)(1), (b)(3) Governance ....................... 494.180(e)(3)
405.2160(b)(2) ................... Medical records ................. 494.170(d)
Director of a renal dialysis facility or renal dialysis cen- 405.2161 ............................ Personnel qualifications .... 494.140(a)
ter.
Medical Director ................ 494.150
Staff of a renal dialysis facility or renal dialysis center ... 405.2162 (stem statement) Governance ....................... 494.180(b)
Adequate numbers of personnel are present to meet 405.2162(a) ....................... Governance ....................... 494.180(b)
patient needs.
(a) Registered nurse ................................................ 405.2162(b) ....................... Personnel qualifications .... 494.140(b) & (e)
(b) On-duty personnel .............................................. 405.2162(b) ....................... Governance ....................... 494.180(b)
(c) Self-care dialysis training personnel ................... 405.2162(c) ....................... Care at home .................... 494.100(a)
Minimal service requirements for a renal dialysis facility 405.2163 ............................ Patient plan of care ........... 494.90 (introductory text)
or renal dialysis center.
(a) Outpatient dialysis services ................................ 405.2163(a) ....................... Patient plan of care ........... 494.90
Care at home .................... 494.100
(b) Laboratory services ............................................ 405.2163(b) ....................... Laboratory services ........... 494.130
(c) Social services .................................................... 405.2163(c) ....................... Patient Assessment ........... 494.80(a)

494)
Patient plan of care ........... 494.90(a)

Care at home .................... 494.100(a)
(d) Dietetic services .................................................. 405.2163(d) ....................... Patient Assessment ........... 494.80(a)
Patient plan of care ........... 494.90
(e) Self-dialysis support services ............................. 405.2163(e) ....................... Care at home .................... 494.100(c)
(f) Participation in recipient registry ......................... 405.2163(f) ........................ Patient plan of care ........... 494.90(c)
(g) Use of erythropoietin at home ............................ 405.2163(g) ....................... Patient Assessment ........... 494.80(a)(4)
Patient plan of care ........... 494.90(a)(3)
Care at home .................... 494.100(a)(2)
(h) Responsibilities of the physician/facility for use 405.2163(h) ....................... Care at home .................... 494.100(b)(2)
of erythropoietin at home.
Conditions for coverage of special purpose renal dialy- 405.2164 ............................ Special purpose renal di- 494.120
sis facilities. alysis facilities.
Director of a renal transplantation center ........................ 405.2170 ............................ Retained in 405, Subpart U
Minimal service requirements for a transplantation cen- 405.2171 (introductory Retained in 405, Subpart U.
ter. text).
405.2171(a)–(e) ................. ............................................
Termination of Medicare coverage .................................. 405.2180 ............................ Termination of Medicare 488.604
coverage.
Alternative sanctions ....................................................... 405.2181 ............................ Alternative sanctions ......... 488.606
Notice of sanction and appear rights: Termination of 405.2182 ............................ Notice of appeal rights: 488.608
coverage. Termination of coverage.
Notice of appeal rights: Alternative sanctions ................. 405.2184 ............................ Notice of appeal rights: Al- 488.610
ternative sanctions.
C. Bibliography Recommendations of CDC and the Ekoyan, Garabed, M.D., Beck, Gerald J.,
Healthcare Infection Control Practices Ph.D., Cheung, Alfred K., M.D. et al.
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Medicine 12 (1983): 860–865. June 6, 2003: 1–44. (Available at England Journal of Medicine 347.25
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Systems. (RD5) 1992. Sections 3.2.1, 3.2.2 ‘‘Appendix H: Survey Procedures and Liquefaciens Bloodstream Infections From
and Appendix B, Sections B1–B5. Interpretive Guidelines for Surveyors of Contamination of Erythropoietin Alfa At A
—Reuse of Hemodialyzers. 1993. End-Stage Renal Disease Facilities.’’ State Hemodialysis Center.’’ New England
—Reuse of Hemodialyzers. (RD47) 2002. Operations Manual. April 1995: Tag V– Journal of Medicine 344.20 (May 17, 2001):
—Reuse of Hemodialyzers (Corrected Copy). 188. 1491–1497. (Available at www.nejm.org)
(RD47) 2003. —Center for Beneficiary Choices. ‘‘2002 Hays, R.D., Kallich, J.D., Mapes, D.L., Coons,
—Concentrates for Hemodialysis. (RD61) Annual Report ESRD Clinical Performance S.J., Carter, W.B. ‘‘Development of the
2000. Measures Project: Opportunities to Kidney Disease Quality of Life (KDQOL)
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Patients.’’ December 2002: 1–104.
Becker, Linda, M.A. et al. ‘‘Cardiac Arrest in ‘‘Mortality and Duration of Hemodialysis
(Available at www.cms.hhs.gov/esrd/1.asp)
Medical and Treatment.’’ Journal of the American
—Food and Drug Administration. ‘‘Guidance
Department of Health and Human Services. for Hemodialyzer Reuse Labeling.’’ 1995. Medical Association 265 (1991): 871–875.
Centers for Disease Control and Prevention. —‘‘Guidance for the Content of Premarket Institute of Medicine. ‘‘Report on Kidney
‘‘Recommendations for Preventing Notification for Water Purification Failure and the Federal Government.’’
Transmission of Infections Among Chronic Components and Systems for Report, 1991.
Hemodialysis Patients.’’ Morbidity and Hemodialysis.’’ 1997. —‘‘To Err is Human: Building a Safer Health
Mortality Weekly Report 50 (RR05) (April —National Institutes of Health. ‘‘Morbidity System.’’ Report, 2000.
27, 2001): 20–21. (Available at and Mortality of Dialysis.’’ Consensus —‘‘Crossing the Quality Chasm: A New
www.cdc.govmmwr/preview/mmwrhtml/ Conference Report, 11.2 (1993): 1–33. Health System for the 21st Century.’’
rr5005al.htm.) —‘‘Study Confirms Recommended Dialysis Report, 2001. (Available at
—‘‘Recommended Infection Control Practices Dose’’. National Institute of Diabetes and www.books.nap.edu/books/0309072808/
for Hemodialysis Units At a Glance.’’ 50 Digestive and Kidney Diseases (April 23, html/indes.html.)
(RR05) (April 27, 2001): 20–21. (Available 2002). (Available at www.nih.gov/news/pr/ Kaplan, B., et al. ‘‘Chronic Hemodialysis
at www.cdc.govmmwr/preview/mmwrhtml/ apr2002/niddk-23.htm) Patients. Part I: Characterization and Drug-
rr5005al.htm.) —Office of the Inspector General. ‘‘External Related Problems.’’ The Annals of
—‘‘Guidelines for Hand Hygiene in Health- Quality Review of Dialysis Facilities: A Pharmacotherapy. 28 (1994): 316–319.
Care Settings: Recommendations of the Call for Greater Accountability.’’ Report, The Life Options Rehabilitation Advisory
Healthcare Infection Control Practice 1999. (p. 131, 189) Council. Renal Rehabilitation, Bridging the
Advisory Committee and the HCIPAC/ —‘‘Clinical Performance Measures for Barriers. 1994. Madison, Wisconsin:
SHEA/APIC/IDSA Hand Hygiene Task Dialysis Corporations, Practices of Major Medical Education Institute, Incorporated.
Force.’’ Morbidity and Mortality Weekly Dialysis Corporations.’’ Report, OEI–01– (Available at www.lifeoptions.org.)
Report 51 (RR16) (October 25, 2002): 1–45. 99–00053, January 2002. Medicare Payment Advisory Commision.
(Available at www.cdc.govmmwr/preview/ —‘‘Clinical Performance Measures for ‘‘Chapter 4: Improving Quality Assurance
mmwrhtml/rr5116al.htm.) Dialysis Facilities: Building on the for Institutional Providers,’’ Report to
—‘‘Guidelines for Environmental Infection Experiences of the Corporations.’’ Report, Congress: Selected Medicare Issues. June
Control in Health-Care Facilities: 2002. 2000. 81–103.
National Fire Protection Association. NFPA VIII. Collection of Information addition, facilities must report infection
101, Life Safety Code Handbook. Chapters Requirements and Response to control issues to the dialysis facility’s
20 and 21. January 12, 2000. Comments chief executive officer or administrator
—Standard for Health Care Facilities.
(see § 494.180(a)) and the quality
Chapter 11: Health Care Emergency A. Collection of Information
Preparedness. November 2001. improvement committee.
Requirements While these requirements are subject
National Kidney Foundation. ‘‘Kidney/
Disease Outcomes Quality Initiative Under the Paperwork Reduction Act to the PRA, the fact that they are usual
Clinical Practice Guidelines for Nutrition of 1995, we are required to provide 60- and customary business practices,
in Chronic Renal Failure.’’ American day notice in the Federal Register and exempts the burden associated with
Journal of Kidney Diseases. 35 (2000): S1– solicit public comment before a these requirements from the PRA as
S140. collection of information requirement is stipulated under 5 CFR 1320.3(b)(2).
—Hemodialysis Adequacy Guidelines. 1997 submitted to the Office of Management The facility must document the
(updated June 2000). Guideline 4. incidence of infection to identify trends
—Peritoneal Dialysis Adequacy Guidelines. and Budget (OMB) for review and
1997 (updated June 2000). Guidelines 15 approval. In order to fairly evaluate and establish baseline information on
and 16. whether an information collection infection incidence, develop
—Guidelines for Advance Directives. 2000. should be approved by OMB, section recommendations to prevent infection
(Available at www.kidneyva.org/public ed/ 3506(c)(2)(A) of the Paperwork transmission and take corrective actions
orderforms.pdf.) Reduction Act of 1995 requires that we to reduce future incidents, and report
—‘‘Kidney/Disease Outcomes Quality solicit comment on the following issues: incidences of communicable diseases as
Initiative Clinical Practice Guidelines for • The need for the information required by Federal, State and local
Vascular Access.’’ American Journal of
collection and its usefulness in carrying laws.
Kidney Diseases 37 (supplement 1) (2001):
S137–S181. out the proper functions of our agency. While this requirement is subject to
—‘‘Disease Outcome Quality Initiative • The accuracy of our estimate of the the PRA, the fact that this requirement
Clinical Practice Guidelines for information collection burden. is a usual and customary business
Hemodialysis Adequacy, Peritoneal • The quality, utility, and clarity of practice and may be required under
Dialysis Adequacy, Vascular Access, and the information to be collected. State or local law, exempts the burden
Anemia for Chronic Kidney Disease.’’ • Recommendations to minimize the associated with this requirement from
American Journal of Kidney Diseases 37 information collection burden on the the PRA as stipulated under 5 CFR
(supplement 1) (January 2001): S182-S238. affected public, including automated 1320.3(b)(2) or (b)(3) or both.
‘‘National Kidney Foundation Dialysis
Technician Task Force.’’ American Journal collection techniques. Section 494.40 Condition: Water
of Kidney Diseases. 21 (1993): 2. We are soliciting public comment on quality. If the test results from the last
Owen, W.F., Jr., Lew, N.L., Lui, Y., et al. each of these issues for the following component or carbon tank are greater
‘‘The Urea Reduction Ratio and Serum sections of this document that contain than the parameters for chlorine or
Albumin Concentration as Predictors of information collection requirements: chloramine described at § 494.30(c)(2)(i)
Mortality in Patients Undergoing Section 414.330 Payment for home the facility must immediately notify the
Hemodialysis.’’ New England Journal of dialysis equipment, supplies and medical director.
Medicine 329 (1993): 1001–1006. support services. Suppliers must report While this requirement is subject to
Parker, T.F., III. ‘‘Role of Dialysis Dose on to the ESRD facility providing support the PRA, the fact that this requirement
Morbidity and Mortality in Maintenance
Hemodialysis Patients.’’ American Journal services, every 30 days, all data for each is a usual and customary business
of Kidney Diseases 24 (1994): 981–989. patient regarding services and items practice, exempts the burden associated
Parker, T.F., III, Husni, L., Haugn, W., et al. furnished to the patient in accordance with this requirement from the PRA as
‘‘Survival of Hemodialysis Patients in the with § 494.100(c)(2) of this chapter. stipulated under 5 CFR 1320.3(b)(2).
United States is Improved with a Greater While this requirement is subject to Section 494.50 Condition: Reuse of
Quantity of Dialysis.’’ American Journal of the PRA, the fact that this requirement hemodialyzers and bloodlines. The
Kidney Diseases 23 (1994): 670–680. is a usual and customary business dialysis facility must monitor patient
Parkerson, G.R. et al. ‘‘The Duke Health practice, exempts the burden associated reactions, undertake evaluation of its
Profile: A 17-Item Measure of Health and
with this requirement from the PRA as dialyzer reprocessing and water
Dysfunction.’’ Medical Care 28.11 (1990):
1056–1069. stipulated under 5 CFR 1320.3(b)(2). purification system, and report any
RAND Corporation. ‘‘Kidney Dialysis Quality Section 488.60 Special procedures adverse outcomes to FDA and other
of Life Short Form, Version 1.3: A Manual for approving end stage renal disease Federal, State, or local governments
for Scoring.’’ 1997. facilities. An ESRD facility that wishes agencies as required by law.
The Renal Physicians Association. The to be approved or that wishes an While this requirement is subject to
Collaborative Leadership for ESRD Patient expansion of dialysis services to be the PRA, the fact that this requirement
Safety, Phase I Report of the National approved for coverage, in accordance is a usual and customary business
Patient Safety Consensus for the with part 494, must submit the practice and is required under other
Community of Stakeholders in End Stage
documents and data as outlined in Federal, State, and local laws, exempts
Renal Disease. Patient Safety Committee
Report. 2001. § 488.60(a)(1) through (a)(4). the burden associated with this
Sciarini, P. and Dungan, J.M. ‘‘A Holistic We estimate that it will take 250 requirement from the PRA as stipulated
Protocol for Management of Fluid Volume facilities on an annual basis 40 hours under 5 CFR 1320.3(b)(2) or (b)(3) or
Excess in Hemodialysis Patients’’ each to gather and submit the necessary both.
Nephrology Nursing Journal 23.3 (1996): documentation for consideration of Section 494.70 Condition: Patients’
299–305. approval. rights. The dialysis facility must inform
Stewart, A.L. et al. ‘‘Functional Status and Section 494.30 Condition: Infection patients (or their representatives) of
Well-Being of Patients with Chronic control. The dialysis facility must their rights and responsibilities when
Conditions.’’ Journal of the American
Medical Association 262.7 (1989): 907–
maintain current infection control they begin their treatment. The facility
913. information including the most current must also inform patients of the
Szczech, L.A. ‘‘Changing Hemodialysis CDC guidelines for the proper facility’s policies for transfer, discharge,
Thresholds for Optimal Survival.’’ Kidney techniques in the use of vials and and discontinuation of services to
International 59 (2001): 738–745. ampules containing medication. In patients.
We estimate that 4,317 facilities will under 5 CFR 1320.3(b)(2) or (b)(3) or of State law, 5 years from the date of
need 8 hours each on an annual basis to both. discharge, including death for adults
disclose the necessary information. This Section 494.120 Condition: Special and 3 years for minors or until the
is based on the belief that the materials purpose renal dialysis facilities. patient reaches legal age under State
will be standardized and incorporated Facilities must contact the patient’s law, whichever is longer.
into the facility’s entrance materials. physician prior to initiating dialysis in While this requirement is subject to
In addition, the dialysis facility must the special purpose renal dialysis the PRA, the fact that this requirement
prominently display a copy of the facility, to discuss the patient’s current is a usual and customary business
patients’ rights in the facility. These condition to assure care provided in the practice, or is required under other
rights must include the current State special purpose renal dialysis facility is Federal, State, and local laws, or both,
agency and ESRD network telephone consistent with the plan of care exempts the burden associated with this
compliant numbers and it must be (specified in § 494.90). requirement from the PRA as stipulated
posted in a place where it can be easily While this requirement is subject to under 5 CFR 1320.3(b)(2) or (b)(3) or
seen and read by patients. the PRA, the fact that this requirement both.
We estimate that 4,317 facilities will is a usual and customary business When a dialysis patient is transferred,
need 1 hour each on an annual basis to practice, or is required under other the transferring facility must provide the
comply with this requirement. Federal, State, and local laws, or both, receiving facility with all medical
Section 494.90 Condition: Patient exempts the burden associated with this records and other information necessary
plan of care. The interdisciplinary team requirement from the PRA as stipulated or useful in the patient’s care or
must develop and implement a written, under 5 CFR 1320.3(b)(2) or (b)(3) or treatment.
individualized comprehensive plan of both. While this requirement is subject to
care that meets the requirements of Facilities must document all care the PRA, the fact that this requirement
§ 494.90. provided in the special purpose facility is a usual and customary business
While this requirement is subject to and forward the documentation to the practice, or is required under other
the PRA, the fact that this requirement patient’s dialysis facility within 30 days Federal, State, and local laws, or both,
is a usual and customary business of the last scheduled treatment in the exempts the burden associated with this
practice, or is required under other special purpose renal dialysis facility. requirement from the PRA as stipulated
While this requirement is subject to under 5 CFR 1320.3(b)(2) or (b)(3) or
Federal, State, and local laws, or both,
the PRA, the fact that this requirement both.
exempts the burden associated with this
is a usual and customary business Section 494.180 Condition:
requirement from the PRA as stipulated
practice, or is required under other Governance. The dialysis facility must
under 5 CFR 1320.3(b)(2) or (b)(3) or
Federal, State, and local laws, or both, have available at the nursing/monitoring
both.
exempts the burden associated with this station, a roster with the names of
Section 494.100 Condition: Care at
requirement from the PRA as stipulated physicians to be called for emergencies,
home. The dialysis facility must
under 5 CFR 1320.3(b)(2) or (b)(3) or when they can be called, and how they
document in the patient’s medical
both. can be reached.
record, that the patient, the caregiver, or Section 494.170 Condition: Medical While this requirement is subject to
both received and comprehended records. The dialysis facility must the PRA, the fact that this requirement
required training. In addition, the maintain complete, accurate, and is a usual and customary business
facility must document, in the patient’s accessible records on all patients, practice, or is required under other
medical record, that the self-monitoring including home patients who elect to Federal, State, and local laws, or both,
data and other information from self- receive dialysis supplies and equipment exempts the burden associated with this
care were reviewed, at least every 2 from a supplier that is not a provider of requirement from the PRA as stipulated
months. ESRD services and all other home under 5 CFR 1320.3(b)(2) or (b)(3) or
While this requirement is subject to dialysis patients whose care is under the both.
the PRA, the fact that this requirement supervision of the facility. The dialysis facility must have a
is a usual and customary business While this requirement is subject to written agreement, that meets the
practice, or is required under other the PRA, the fact that this requirement requirements in § 494.180, with a
Federal, State, and local laws, or both, is a usual and customary business hospital that can provide inpatient care,
exempts the burden associated with this practice, or is required under other other hospital services, and emergency
requirement from the PRA as stipulated Federal, State, and local laws, or both, medical care that is available 24 hours
under 5 CFR 1320.3(b)(2) or (b)(3) or exempts the burden associated with this a day, 7 days a week.
both. requirement from the PRA as stipulated While this requirement is subject to
Section 494.110 Condition: Quality under 5 CFR 1320.3(b)(2) or (b)(3) or the PRA, the fact that this requirement
assessment and performance both. is a usual and customary business
improvement. The dialysis facility must The dialysis facility must obtain practice, or is required under other
develop, implement, maintain, and written authorization from the patient or Federal, State, and local laws, or both,
evaluate an effective, data-driven legal representative before releasing exempts the burden associated with this
interdisciplinary quality assessment and information that is not compelled by requirement from the PRA as stipulated
performance improvement program that law. under 5 CFR 1320.3(b)(2) or (b)(3) or
reflects the complexity of the dialysis While this requirement is subject to both.
facility’s organization and services. the PRA, the fact that this requirement The facility must provide each patient
While this requirement is subject to is a usual and customary business with written notice 30 days in advance
the PRA, the fact that this requirement practice, exempts the burden associated of the facility reducing or terminating
is a usual and customary business with this requirement from the PRA as ongoing care after following the
practice, or is required under other stipulated under 5 CFR 1320.3(b)(2). procedure specified in § 494.180(f).
Federal, State, and local laws, or both, Patient records must be retained for a We estimate that 500 facilities will
exempts the burden associated with this period of time not less than that need 1 hour on an annual basis to
requirement from the PRA as stipulated required by State law, or in the absence provide the required disclosure. This is
based on the assumption that the ‘‘Impact Analysis’’ at the beginning of necessary to bring these facilities into
disclosure will be standardized and will your comment.] conformity with what is becoming
not be required by the majority of standard practice in the renal field and
A. Overall Impact
facilities. to provide essential quality in health
The dialysis facility must furnish data We have examined the impact of this care, potentially saving lives. For these
information electronically to CMS at rule as required by Executive Order reasons, we are not preparing analyses
intervals specified by the Secretary, 12866 (September 1993, Regulatory for either the RFA or section 1102(b) of
which meet the requirements referenced Planning and Review), the Regulatory the Act because we have determined,
in this section. Flexibility Act (RFA) (September 19, and we certify, that this rule will not
While these requirements are subject 1980, Public Law 96–354), section have a significant economic impact on
to the PRA, they are currently approved 1102(b) of the Social Security Act, the a substantial number of small entities or
under the following OMB approval Unfunded Mandates Reform Act of 1995 a significant impact on the operations of
numbers: 0938–0046, 0938–0360, 0938– (Pub. L. 104–4), and Executive Order a substantial number of small rural
0386, 0938–0657, and 0938–0658. 13132. facilities.
In accordance with §§ 420.200 Executive Order 12866 directs
agencies to assess all costs and benefits In addition, section 1102(b) of the Act
through 420.206 of this chapter, the requires us to prepare a regulatory
governing body must report ownership of available regulatory alternatives and,
if regulation is necessary, to select impact analysis if a rule may have a
interests of 5 percent or more to its State significant impact on the operations of
survey agency. regulatory approaches that maximize
net benefits (including potential a substantial number of small rural
While these requirements are subject
economic, environmental, public health hospitals. Since this rule applies only to
to the PRA, it is currently approved
and safety effects, distributive impacts, dialysis facilities, it has no impact on
under OMB approval number 0938–
and equity). A regulatory impact small rural hospitals.
0086.
We have submitted a copy of this analysis (RIA) must be prepared for Section 202 of the Unfunded
proposed rule to OMB for its review of major rules with economically Mandates Reform Act of 1995 also
the information collection requirements significant effects ($100 million or more requires that agencies assess anticipated
in §§ 414.330, 488.60, 494.40, 494.50, in any 1 year). This rule is a proposed costs and benefits before issuing any
494.70, 494.80, 494.90, 494.100, revision of the Medicare conditions for rule that may result in expenditures in
494.110, 494.120, 494.170, and 494.180. coverage for end-stage renal disease any one year by State, local, or tribal
These requirements are not effective (ESRD) facilities. The conditions for governments, in the aggregate, or by the
until they have been approved by OMB. coverage are the basic health and safety private sector, of $110 million. This rule
If you comment on these information requirements that an ESRD supplier of has no impact on the expenditures of
collection and recordkeeping services must meet in order to receive State, local or tribal governments, and
requirements, please mail copies payment from the Medicare program. the impact on the private sector is
directly to the following: This proposed rule would incorporate estimated to be less than $110 million.
Centers for Medicare & Medicaid new scientific advances and current Executive Order 13132 establishes
Services, Office of Strategic medical practices in treating ESRD certain requirements that an agency
Operations and Regulatory Affairs, while removing numerous burdensome must meet when it promulgates a
Regulations Development and process and procedural requirements proposed rule (and subsequent final
Issuances Group, Attn: Dawn contained in the existing conditions for rule) that imposes substantial direct
Willinghan, Room C4–26–05, 7500 coverage. While it is not possible at this requirement costs on State and local
Security Boulevard, Baltimore, MD point to determine definitively the governments, preempts State law, or
21244–1850; and additional costs to the Medicare otherwise has Federalism implications.
Office of Information and Regulatory program resulting from this rule, we This rule will not have any effect on
Affairs, Office of Management and believe that the impact will be below State and local governments. The costs
Budget, Room 10235, New Executive the $100 million threshold; and associated with treating ESRD are
Office Building, Washington, DC therefore, believe that this proposed rule currently a Medicare-covered benefit for
20503, Attn: Christopher J. Martin, is not a major rule. individuals with ESRD. This rule will
CMS Desk Officer, The RFA requires agencies to analyze not increase the costs of the Medicare
Christopher_J._Martin@omb.eop.gov. options for regulatory relief of small program.
Fax: (202) 395–6974. entities. For purposes of the RFA, small
entities include small businesses, B. Impact of the Proposed Policy
B. Response to Comments nonprofit organizations and government Changes
Because of the large number of items agencies. Individuals and States are not 1. Retained Requirements
of correspondence we normally receive included in the definition of small
on Federal Register documents entity. According to the latest numbers We note that we have retained a
published for comment, we are not able from the Small Business number of requirements from the
to acknowledge or respond to them Administration’s North American existing regulations in this proposed
individually. We will consider all Industrial Classification System, 37 rule. Therefore, these requirements do
comments we receive by the date and percent (1,751) of dialysis facilities have not add any new financial burden for
time specified in the DATES section of revenues of $29 million or less dialysis facilities. These requirements
this preamble, and, if we proceed with annually; and therefore, are considered include the following:
a subsequent document, we will to be small entities. Thirty of these • Special procedures for approving
respond to the major comments in the facilities have annual revenue less than end stage renal disease facilities.
preamble to that document. $100,000. It is possible that this • Infection control.
proposed regulation could cost some of
X. Regulatory Impact Analysis these small facilities an additional • Water quality.
[If you choose to comment on issues in $6,545 (about 6.5 percent of $100,000). • Reuse of hemodialyzers.
this section please include the caption However, this is an essential upgrading • Patient plan of care.
2. Physical Environment and Emergency preamble, USRDS data on causes of hiring translators. This results in a net
Preparedness death among hemodialysis patients reduction in facility costs.
The existing regulations require between 1997 and 1999 indicates that The existing regulations require that
dialysis facilities to have written nearly half (49 percent) of the deaths advance notice be given to patients who
policies and procedures for handling were attributable to cardiovascular are being terminated from a dialysis
emergencies with annual reviews, conditions, with cardiac arrest ranking facility. The proposed rule is more
testing, and revisions, and staff training first among the specified causes. specific and requires that written notice
One study found that the typical be given 30 days in advance. However,
to handle any emergency or disaster.
dialysis facility faces one cardiac arrest since involuntary terminations are a
Facilities are now expending resources
each year (Becker, pp. 1509–1512). The relatively infrequent occurrence, we
to develop procedures and train staff for
study estimated the cost of AEDs at consider the financial impact on
natural disasters that had never been
$3,000, with a useful life of 10 years, dialysis facilities to be negligible.
known to occur in their region. The
that is, $300 annually for each life
proposed rule requires only that the potentially saved. Currently, AEDs can We estimate that 569 facilities will
staff be able to demonstrate the ability be purchased for $2,000 with a useful need 1 hour at $15 an hour on an annual
to manage emergencies that are likely to life of 10 years (that is, an AED can be basis to provide the required disclosure
occur in the facility’s geographic area. use at a cost of $200 each year for 10 for a total annual cost of $8,535 (569 ×
Although an annual review would still years). 1 × 15). This is based on the assumption
be required, the proposed rule does not Since 19 percent of dialysis facilities that the disclosure will be standardized
require the involvement of the CEO in are hospital-based, it is presumed that and will not be required by the majority
this activity. We estimate a typical these facilities have already met the of facilities.
facility will expend 4 hours less of staff requirement, since they have access to
time for this activity at $50 per hour, 4. Quality Assessment and Performance
an in-hospital defibrillator. However, Improvement
with a net savings of $200 per year for we assume that all of the remaining 81
an overall savings of $947,000. percent of facilities would have to Existing regulations are not
The proposed rule requires that the acquire this piece of equipment. The comparable to the proposed rule’s
facility meet the 2000 edition of Life only ongoing annual costs for requirement that the facility develop,
Safety Code (LSC) requirements of the maintaining the equipment are those for implement, maintain, and evaluate a
National Fire Protection Association. testing and replacing batteries, and data-driven QAPI program. However,
Most dialysis facilities currently meet these costs are negligible. The cost of quality improvement efforts are
most of the provisions required in AEDs in 81 percent of dialysis facilities considered part of the professional
Chapter 21 of the LSC because of State is estimated to be $7,670,700. We have staff’s job and the renal community has
and local building codes as well as requested public comment regarding the developed considerable consensus in
facilities’ own liability purposes. AED proposal as well as comments recent years in regard to clinical
However, there may be some burden for regarding the appropriateness of waivers performance data. The top 5 dialysis
existing facilities in regard to the or a phase-in period or both for small chains, representing two-thirds of all
installation and maintenance of the fire rural dialysis facilities. dialysis facilities are already collecting
department alarm connection. We and reporting standardized data on 14
estimate that approximately 1,136 3. Patients’ Rights
data elements, some of which are
facilities will need to be upgraded to The existing regulations require reported to the USRDS.
meet this requirement. The one-time dialysis facilities to have written
cost to install a fire department or patients’ rights policies and procedures This proposed rule simply requires
central monitoring station connection is and a list of numerous persons to whom the facilities to use this data internally,
estimated to be $1,000 per facility. The the patient rights policies must be made in a formal QAPI program that each
monthly fee for the monitoring station available. The proposed rule details facility has the flexibility to develop to
and telephone cost is estimated to be basic information that must be provided suit its own purposes. The two-thirds of
about $80. Thus, we estimate the to patients (for example, advance dialysis facilities in the top five chains
additional overall cost of compliance for directives and how to contact entities in are already complying with this
facilities in the first year will be regard to complaints) but only requires requirement and many others also
$2,226,500, with the annual cost that patient rights be prominently consider use of this data as part of their
thereafter being $1,090,560 ($80 month displayed. Proposing minimum contents standard practice. We estimate that the
X 12 months X 1,136 facilities). in the patients’ rights condition, and QAPI requirements would impose a
This estimate does not take into proposing only that these rights be burden on no more than 10 percent of
account any specific waivers or posted, will limit the administrative the dialysis facilities (that is, 473
acceptance of a State code in lieu of the burden. We estimate that this will save facilities).
LSC that may decrease the burden. If the the typical facility about 2 hours of staff Assuming that a facility were
health and safety of patients and staff time at $15 per hour, that is, $30 initiating a QAPI program only as a
are not adversely affected, the proposed annually, for an overall savings of result of this proposed rule, this may
rule would permit us to waive specific $142,050. entail a 1-hour meeting of 4 staff
provisions of the LSC, which, if rigidly The existing regulations require persons quarterly, with each staff person
applied, would result in an translators when a significant number of having an additional hour of work each
unreasonable hardship on the facility. In patients exhibit language barriers. The month beyond the meeting (that is, 16
addition, the proposed rule specifies proposed rule would delete this staff hours of meeting time + 48 staff
that the Secretary, may accept a State requirement and specify information be hours beyond meetings = 64 hours
code in lieu of the LSC, if it adequately given to patients in a manner that annually). Assuming that the average
protects patients. assures their understanding. However, staff cost is $25, the total additional cost
The proposed rule requires that every translators could still be used and to the facility would be $1,600 annually.
dialysis facility have access to a facilities would have more flexibility in The total cost for 473 facilities would be
defibrillator. As discussed earlier in this overcoming language barriers in lieu of $756,800.
5. Medical Records a State where there are no credentialing be provided by CMS and its ESRD
In the proposed rule, essential requirements for dialysis technicians, Networks without cost to the dialysis
requirements in regard to retention, are not likely to be burdened with the industry, and some of the training will
preservation, and transfer of medical requirement to develop a dialysis be done using an Internet Web tool.
training program, since they can request However, we do estimate that there
records would be retained. However, the
medical director and governing body will be some additional costs involved
existing regulations are highly
approval to use a packaged curriculum in: (1) Travel costs to training sites for
prescriptive in not only requiring the
that includes a water treatment system some dialysis facility or chain
designation of a medical records
module, which has been developed by representatives; (2) computer hardware
supervisor, but in detailing that person’s
organizations in the renal field and is and Internet Service Provider (ISP)
duties, specifying categories of
available to any dialysis facility without connections for some facilities; and (3)
information to be included in the
cost. collecting and transmitting data on the
medical record, requiring written residual patients who are not served by
policies and procedures to protect 7. Clinical Performance Measures the major dialysis chains and who are
medical records information, and even The proposed rule would add a not part of the 5 percent sample of
addressing spatial issues in regard to the requirement that all dialysis facilities patients in the current CPM project. The
maintenance and processing of medical electronically collect and report ESRD detail in these estimates is as follows:
records. The proposed rule would delete CPM Project data on all patients. The • Estimated costs for travel to training
many of these requirements, giving the data include several measures of sites will be approximately $200 for
facility flexibility in deciding how the dialysis adequacy, vascular access, each facility/chain representative and
medical records are to be maintained anemia management and nutrition. we estimate that 2,000 persons will be
and what is to be in them, as long as Any potential burden added by this sent for training, most representing
they facilitate positive patient outcomes. requirement is mitigated by the chains of dialysis facilities. The total
This reduces burden on the dialysis following: cost of travel to training would, then, be
facilities. We estimate that this will save • More than half the dialysis facilities $400,000, and this would be only for the
the typical facility about 40 hours of a already collect data on at least 14 initial year of implementation;
medical records professional’s time, at clinical performance measures, • Very few dialysis facilities would
$15 per hour, that is, $600 annually for including measures that evaluate have to purchase computer hardware to
an overall savings of $2,841,000. adequacy of dialysis treatment, anemia, implement this requirement, possibly
6. Governance nutritional level, vascular access, bone no more than 142 (3 percent of total
disease, and hypertension. Many units facilities). We estimate the cost of this
The existing regulations specify the affiliated with the major dialysis chains purchase to be $1,000. Thus, the total
minimum requirements for CEO have integrated their electronic data cost for purchasing hardware would be
education and experience, whereas the systems for quality management with $142,000, and this would be only in the
proposed rule would delete these their data systems for patient initial year of implementation. We
requirements. management, to minimize the data estimate ISP costs to be $150 annually
However, the proposed rule would reporting burden. These facilities ($150 × 142 facilities = $21,300);
add new requirements, for a training understand that it is important to collect • The estimated 5 percent annual
program for water treatment system and to use the data to allow an accurate growth rate in the ESRD population
technicians and a written training comparison of the facility’s performance would mean that in 2005 there will be
program for dialysis patient care relative to that of its peers, since these approximately 337,839 ESRD
technicians, in regard to the operation of comparisons can serve to identify beneficiaries. We believe that the larger
kidney dialysis equipment and significant opportunities for chains are already collecting CPM data
machines and the provision of patient improvement. on approximately 65 percent of these
care. This training program would be • CPM data is already reported to patients. Since the CPM project requires
developed or adopted by the facility and CMS on a voluntary basis for a 5 percent submission of this data on a 5 percent
must be approved by the medical national sample of patients, so many sample, we assume that the burden is
director and the governing body of the facilities are already familiar with the only in regard to 95 percent of the
facility. The water system training data reporting and collection process. remaining 35 percent of patients. Thus,
program may be written, audiovisual, or • The CPM data set will become a we estimate that additional CPM data
computer based. Since the major part of the Consolidated Renal collection and reporting will be required
dialysis chains all have training Operations in a Web-enabled Network for 112,331 patients annually (337,839 ×
programs for their dialysis patient care (CROWN) data system, and CMS will .35 × .95). Based on current CPM project
technicians and water treatment supply VISION software free to dialysis norms, we assume: One-half hour to
technicians, and the majority of dialysis facilities to permit them to enter CPM abstract the data from the medical
facilities are affiliated with these chains, data electronically directly into the record by staff who are typically paid
a large portion of facilities already meet system. VISION is available for general $25 per hour, for a cost of $1,404,142
this requirement. In addition, at least 11 use and is currently being used by 138 (112,331 × .5 × $25) annually; and key-
States already have some form of independent dialysis facilities. Any entry at the rate of 12 patients per hour
credentialing (training; competency dialysis facility that chooses to by staff who are typically paid $12 per
exam; certification) requirements for voluntarily participate in the CPM hour, for a cost of $112,331 annually.
dialysis patient care technicians, so Project will be allowed to do so before Thus, in the first year of
dialysis facilities in these States, if they the publication of a final rule. This implementation, the total financial
are unaffiliated with a major chain, may could substantially reduce the number impact on the dialysis facilities of
simply declare that meeting the State of facilities that need to be brought on implementing the CPM requirement is
credentialing requirement is equivalent line before the effective date of the final estimated to be $2,079,774; thereafter,
to completion of their training program. rule. the cost would be approximately
Even facilities that are not affiliated • Training for purposes of $1,537,774 ($1,404,142 + $112,331 +
with a major dialysis chain and are in implementing the CPM requirement will $21,300) annually for collecting and
transmitting the data and paying the

ISP.
COST ESTIMATE FOR THE COLLECTION OF CPM DATA

$400,000 for travel to training (first year).
$142,000 for computer hardware (first year).
$1,537,474 for abstracting & key-entry of CPM data and ISP annually.
$2,079,774 Total
The following chart provides an

overall estimate of the impact of the
proposed rule:
OVERALL IMPACT OF THE PROPOSED RULE ON THE ECONOMY

4,735 facilities disaster planning burden @ $200 ................................................................................................................... = ¥$947,000
1,136 facilities (24%) LSC upgrades @ $1,960 ...................................................................................................................... = +2,226,560
3,835 facilities (81%) purchasing AEDs @ $3,000 ................................................................................................................. = +7,670,700
4,735 facilities (patient rights distribution) @ $30 ................................................................................................................... = ¥142,050
473 facilities (QAPI) @ $1,600 ................................................................................................................................................ = +756,800
4,735 facilities (medical records burden) @ $600 ................................................................................................................... = ¥2,841,000
569 facilities (30-day discharge notice) @ $15 ....................................................................................................................... = +8,535
CPM reporting requirement (detailed above) ........................................................................................................................... = 2,079,774
Total impact on the economy ........................................................................................................................................... = +8,812,319
C. Anticipated Effects of the Revised hepatitis C is not a Medicare-covered newer AAMI document—RD62: 2001
ESRD Conditions on Suppliers of ESRD service. and additional requirements that are
Services Another alternative was to propose compatible with ANSI/AAMI RD52:
compliance with all of the CDC 2004 because RD62 and RD52, are the
The Medicare conditions for coverage guidelines in the RR05 report rather state-of-the-art water quality guidelines.
for ESRD facilities have not been revised than just the crucial ‘‘Recommended We have asked for comments on this
in their entirety since their original Infection Control Practices for proposal.
publication in 1976. The revisions in Hemodialysis Units At a Glance’’ (At a
this proposed rule reflect, for the most Glance) requirements. However, 4. Reuse of Hemodialyzers and
part, advances in dialysis technology although we encourage compliance with Bloodlines
and standard care practices. Transplant the entire report, we decided against One potential cost-saving alternative
centers will not be affected because they proposing compliance with the entire was to remove the proposal that
are not included in this rule. One of the report. Our rationale was compliance dialyzers exposed to more than one
major purposes of this revision is to be with guidelines in the entire report germicide were acceptable for reuse. We
responsive to regulatory reform would reduce flexibility and add decided against this proposal because
initiatives, eliminating unnecessary unnecessary burden for dialysis exposure to different germicides may
procedural requirements and focusing facilities since some of the guidelines cause membrane leaks and we have no
on better patient outcomes of care. exceed the scope of these health and scientific evidence to support the safety
D. Alternatives Considered safety requirements. of using dialyzers exposed to more than
A third alternative was to propose one germicide.
1. Maintenance of Existing Regulations compliance with AIA Guidelines for
Design and Construction of Hospitals 5. Physical Environment and Emergency
One alternative would be to keep the and Health Care Facilities. The AIA Preparedness
existing regulations. However, the guidelines provide instructions One alternative was to remove the
current regulations inhibit our ability to regarding dialysis unit design as it proposal that every dialysis facility have
ensure better outcomes of patient care, relates to infection control. While some a defibrillator. We retained this proposal
collect electronic data for quality states have adopted specific AIA because a Seattle study (Becker, pp.
assurance and quality improvement, guidelines as minimal standards, we 1509–1512) identified dialysis centers
incorporate new CDC and AAMI believe it would be too burdensome on as having a relatively high incidence of
guidelines and fire safety standards and dialysis facilities to propose to cardiac arrests over a 7-year period.
reduce current facility burden by incorporate AIA guidelines as federal Also, automated external defibrillators
eliminating numerous process and requirements. are now required on airliners and in
procedural requirements. other public places because the
3. Water Quality technology is simple to use, staff can be
2. Infection Control
One alternative was to propose to trained on the use of such equipment,
One alternative was not proposing an continue to require compliance with and the technology has been proven to
exception to the CDC recommendation portions of the current AAMI save lives.
for monthly and semiannual screening guidelines,—ANSI/AAMI RD5: 1992 A second alternative was to propose
for hepatitis C. We retained the Appendix B5. However, we decided to a waiver or phase-in period for
exception because blanket screening for propose compliance with portions of the defibrillators in small rural satellite
dialysis facilities with very low guidelines (reuse), and specific However, a June 2000 OIG report
utilization. We are considering this recommendations from the OIG strongly recommended that we
alternative and have requested public (medical error identification and patient strengthen the role of the facility’s
comments on the defibrillator proposal. satisfaction) that there was sufficient medical director. In response to that
basis to include 7 basic criteria. We recommendation, we proposed to retain
6. Patients’ Rights the condition with a clarification of the
have requested public comment on
One alternative was to remove the QAPI. medical director’s responsibilities to
proposal for advance directives. We include overseeing both the QAPI
retained this proposal because of the 10. Special Purpose Renal Dialysis
program and all involuntary patient
nature of ESRD and the aging dialysis Facilities
transfers or discharges. We do not
population. One alternative was to remove this believe that this approach would
Another alternative considered was condition entirely based on historically impose an additional cost burden on
not proposing that dialysis facilities low levels of participation. We dialysis facilities. We have requested
have an internal grievance procedure. determined that eliminating this public comments on these proposals.
We did not adopt this alternative condition would be detrimental to the
because we believe an internal small number of vacation camps that 13. Governance
grievance process is essential to allow choose to participate and it would also One alternative considered was to
patients to express their concerns inhibit access to care during natural remove the proposal for a 30-day
directly to the facility in which they disasters. advanced notice before involuntary
receive dialysis. Another alternative was to retain the patient discharge or transfer and retain
current 8-month certification period and the existing requirement (see
7. Patient Assessment the current certification requirements. § 405.2138(b)(2)) for patients to be
One alternative was to include We believe that the current certification ‘‘given advance notice to ensure orderly
‘‘extremely frail patients’’ in the requirements are onerous; we believe transfer or discharge.’’ We did not adopt
proposal to reassess unstable patients that this is demonstrated by the lack of this alternative because: (1) A 30-day
monthly. This proposal was not adopted participation in Medicare by vacation advance notice for discharge and
in order to ensure that dialysis facilities camps. We believe proposing to reduce transfer has been consistent with the
retain the flexibility to make clinical the number of certification requirements existing requirements in NFs, SNFs, and
determinations on a case-by-case basis. addresses this issue. The existing 8- hospital swing-beds for over 12 years;
Another alternative was to remove the month certification period is also (2) the dialysis patient population is
proposal for a 3-month timeframe to excessive (that is, vacation camps are increasingly older and many are nursing
reassess new patients. We are aware that typically not open for 8 months and home residents with co-morbid
the dialysis industry has not reached natural emergencies are of shorter conditions; and (3) large dialysis chains
consensus regarding the appropriate duration). The current proposal have emerged that can offer more
frequency for reassessments, and represents a significant reduction in flexibility and options for a patient
therefore, we have requested comments administrative burden for special involuntarily discharged from a facility
on the current proposal to reassess new purpose units. by providing numerous units nearby or
patients 3 months after starting dialysis. within commuting distance of that
11. Personnel Qualifications patient’s place of residence. We have
8. Patient Plan of Care One alternative was to retain the added a proposal to waive the 30-day
One alternative was to retain the existing requirement that at least a notice under unusual circumstances.
existing requirement for an licensed practical nurse must be on the This proposed rule contains a
individualized care plan with a 6-month premises during dialysis. We decided to requirement for every dialysis facility to
review and a long-term program with an propose that a registered nurse be on the report ESRD CPM Project data to CMS.
annual review. We did not adopt this premises during dialysis to protect One option considered was to propose
approach because it was less patient health and safety and because that less than 100 percent of facilities be
burdensome to propose a single this did not represent an increase in required to participate. However,
individualized plan of care (without a burden for dialysis units. section 4558(b) of Pub. L. 105–33
long-term program) to be reviewed Other options were to propose no requires CMS to monitor the quality of
annually. Federal requirements for dialysis care delivered to dialysis patients. To
Another alternative was to propose to technicians, or, to propose minimal date, CMS has been collecting a 5
adopt specific evidence-based NKF–K/ Federal requirements for dialysis percent CPM patient sample on a
DOQI clinical practice guidelines as technicians and include proposals for voluntary basis. CPM electronic data
numerical minimum target values competency testing and certification. A collection has been pilot-tested and is
within the patient plan of care condition detailed discussion of this issue is in expected to be ready for general use in
(that is, adequacy of dialysis and anemia section VI.A.5 of this preamble. We 2005. A gradual voluntary phase-in will
management). This issue is discussed in determined that minimal Federal be undertaken for facilities that want to
detail in the preamble and we are requirements are needed at this time participate before full implementation.
requesting public comments on the because dialysis technicians are the We believe that 100 percent CPM data
issue. primary caregivers in most dialysis collection is necessary to comply with
facilities. However, we did not propose the intent of the statute. The large chain
9. Quality Assessment and Performance dialysis facilities and many other
competency testing or certification and
Improvement dialysis facilities already collect this
have requested public comment.
One alternative was to propose a data for benchmarking and quality
QAPI program without specific 12. Medical Director improvement purposes, and therefore,
threshold criteria. We determined, One alternative was to propose to this will not create a significant new
based on the work of the NFK–K/DOQI eliminate the medical director condition burden for the industry. However, small
committees (adequacy, nutrition, and propose that other health care rural facilities may have a difficult time
anemia, and vascular access), AAMI professionals run dialysis facilities. coming into compliance, and therefore,
we are considering a phase-in period for Subpart U—Conditions for Coverage § 410.5 [Amended]
these facilities. for Suppliers of Renal Transplantation 2. In § 410.5(a), the reference ‘‘Part
In accordance with the provisions of Services and Requirements for ESRD 405, subpart U’’ is revised to read ‘‘Part
Executive Order 12866, this regulation Networks 494’’.
was reviewed by the Office of §§ 405.2100, 405.2101, 405.2135 through § 410.50 [Amended]
Management and Budget. 405.2164, and 405.2180 through 405.2184 3. In § 410.50(b), the reference
List of Subjects [Removed and Reserved] ‘‘§ 405.2163(b)’’ is revised to read
3. Sections 405.2100, 405.2101, ‘‘§ 494.130’’; and the reference ‘‘subpart
42 CFR Part 405 405.2135 through 405.2164, and M of part 405’’ is revised to read ‘‘part
Administrative practice and 405.2180 through 405.2184 are removed 494’’.
procedure, Health facilities, Health and reserved.
4. Section 405.2102 is revised to read § 410.52 [Amended]
professions, Kidney diseases, Medical
devices, Medicare, Reporting and as follows: 4. Section 410.52 is amended as
recordkeeping requirements, Rural follows:
§ 405.2102 Definitions. a. In paragraph (a)(4), the reference to
areas, X-rays. As used in this subpart, the following ‘‘§ 405.2163’’ is revised to read
42 CFR Part 410 definitions apply: ‘‘§ 494.90(a)(3)’’.
ESRD Network organization. The b. In paragraph (b), the parenthetical
Health facilities, Health professions, administrative governing body to the statement ‘‘(Section 405.2137 of this
Kidney diseases, Laboratories, network and liaison to the Federal chapter contains specific details.)’’ is
Medicare, Reporting and recordkeeping government. revised to read ‘‘(Section 494.90 of this
requirements, Rural areas, X-rays. Histocompatibility testing. Laboratory chapter contains details on patient plans
test procedures which determine of care.)’’
42 CFR Part 413
compatibility between an organ donor
Health facilities, Kidney diseases, and a potential organ transplant § 410.152 [Amended]
Medicare, Reporting and recordkeeping recipient. 5. In § 410.152(e)(1), ‘‘subpart U of
requirements. Network, ESRD. All Medicare- part 405’’ is revised to read ‘‘part 494’’.
approved ESRD facilities in a designated
42 CFR Part 414 geographic area specified by CMS. § 410.170 [Amended]
Organ procurement. The process of 6. In § 410.170(c), the reference to
Administrative practice and ‘‘§ 405.2137(b)(3)’’ is revised to read
acquiring donor organs. (See definition
procedure, Health facilities, Health ‘‘§ 494.90’’.
of Organ procurement organization in
professions, Kidney diseases, Medicare,
§ 486.302 of this chapter.)
Reporting and recordkeeping Renal transplantation center. A PART 413—PRINCIPLES OF
requirements. hospital unit which is approved to REASONABLE COST
42 CFR Part 488 furnish directly transplantation and REIMBURSEMENT; PAYMENT FOR
other medical and surgical specialty END-STAGE RENAL DISEASE
Administrative practice and services required for the care of the SERVICES; OPTIONAL
procedure, Health facilities, Medicare, ESRD transplant patients, including PROSPECTIVELY DETERMINED
and Reporting and recordkeeping inpatient dialysis furnished directly or PAYMENT RATES FOR SKILLED
requirements. under arrangement. A Renal NURSING FACILITIES
42 CFR Part 494 Transplantation Center may also be a 1. The authority citation for part 413
Renal Dialysis Center. continues to read as follows:
Health facilities, Kidney diseases, Transplantation service. A process by
Medicare, Reporting and recordkeeping which (1) a kidney is excised from a live Authority: Secs. 1102, 1812(d), 1814(b),
1815, 1833(a), (i), (n), 1861(v), 1871, 1881,
requirements. or cadaveric donor, (2) that kidney is
1883, and 1886 of the Social Security Act (42
implanted in an ESRD patient, and (3) U.S.C. 1302, 1395d(d), 1395f(b), 1395g,
For the reasons stated in the preamble supportive care is furnished to the
of this proposed rule, the Centers for 1395l(a), (i), and (n), 1395x(v), 1395hh,
living donor and to the recipient 1395rr, 1395tt, and 1395ww).
Medicare & Medicaid Services proposes following implantation.
to amend 42 CFR chapter IV as follows: Transplantation surgeon. A person 2. In § 413.170, paragraph (a) is
who— revised to read as follows:
PART 405—FEDERAL HEALTH
(1) Is board eligible or board certified § 413.170 Scope.
INSURANCE FOR THE AGED AND
in general surgery or urology by a This subpart implements sections
DISABLED
professional board; and 1881(b)(2) and (b)(7) of the Act by—
Subpart U—Conditions for Coverage of (2) Has at least 12 months training or (a) Setting forth the principles and
End-Stage Renal Disease (ESRD) experience in the performance of renal authorities under which CMS is
Services transplantation and the care of patients authorized to establish a prospective
with renal transplants. payment system for outpatient
1. The authority citation for part 405, maintenance dialysis furnished in or
subpart U continues to read as follows: PART 410—SUPPLEMENTARY
MEDICAL INSURANCE (SMI) under the supervision of a dialysis
Authority: Secs. 1102, 1138, 1861, 1862(a), BENEFITS facility under part 494 of this chapter
1871, 1874, and 1881 of the Social Security (referred to as ‘‘facility’’). For purposes
Act (42 U.S.C. 1302, 1320b-8, 1395x, 1. The authority citation for part 410 of this section and §§ 413.172 through
1395y(a), 1395hh, 1395kk, and 1395rr), continues to read as follows: 413.198, ‘‘outpatient maintenance
unless otherwise noted. dialysis’’ means outpatient dialysis
Authority: Secs. 1102 and 1871 of the
2. The title of the subpart is revised Social Security Act (42 U.S.C. 1302 and provided by a dialysis facility, home
to read as follows: 1395hh). dialysis or self-dialysis as defined in
§ 494.10 of this chapter and includes all § 414.330 Payment for home dialysis Subpart H—Termination of Medicare
items and services specified in equipment, supplies, and support services. Coverage and Alternative Sanctions
§§ 410.50 and 410.52 of this chapter. (a) * * * for End Stage Renal Disease (ESRD)
* * * * * Facilities
3. In § 413.172, paragraph (b) is (2) * * *
(iii) * * * § 488.604 Termination of Medicare
revised to read as follows:
coverage.
§ 4l3.172 Principles of prospective
(C) Agrees to report to the ESRD (a) Except as otherwise provided in
payment. facility providing support services, this subpart, failure of a supplier of
* * * * * every 30 days, all data for each patient ESRD services to meet one or more of
(b) All approved ESRD facilities must regarding services and items furnished the conditions for coverage set forth in
accept the prospective payment rates to the patient in accordance with part 494 of this subchapter will result in
established by CMS as payment in full § 494.100(c)(2) of this chapter. termination of Medicare coverage of the
for covered outpatient maintenance * * * * * services furnished by the supplier.
dialysis. Approved ESRD facility (b) If termination of coverage is based
means— PART 488—SURVEY, CERTIFICATION, solely on a supplier’s failure to
(1) Any independent or hospital- AND ENFORCEMENT PROCEDURES participate in network activities and
based facility (as defined in accordance pursue network goals, as required at
with § 413.174(b) and (c) of this part) 1. The authority citation for part 488 § 494.160 of this subchapter, coverage
that has been approved by CMS to continues to read as follows: may be reinstated when CMS
participate in Medicare as an ESRD Authority: Secs. 1102 and 1871 of the determines that the supplier is making
supplier; or Social Security Act (42 U.S.C. 1302 and reasonable and appropriate efforts to
(2) Any approved independent facility 1895hh). meet that condition.
with a written agreement with the (c) If termination of coverage is based
Secretary. Under the agreement, the 2. In § 488.60 paragraph (a) is revised on failure to meet any of the other
independent ESRD facility agrees— to read as follows: conditions specified in part 494 of this
(i) To maintain compliance with the subchapter, coverage will not be
§ 488.60 Special procedures for approving
conditions for coverage set forth in part end stage renal disease facilities. reinstated until CMS finds that the
494 of this chapter and to report reason for termination has been
promptly to CMS any failure to do so; (a) Consideration for approval. An removed and there is reasonable
and ESRD facility that wishes to be assurance that it will not recur.
(ii) Not to charge the beneficiary or approved or that wishes an expansion of
any other person for items and services dialysis services to be approved for § 488.606 Alternative sanctions.
for which the beneficiary is entitled to coverage, in accordance with part 494 of (a) Basis for application of alternative
have payment made under the this subchapter, must secure a sanctions. CMS may, as an alternative to
provisions of this part. determination by the Secretary. To termination of Medicare coverage,
* * * * * secure a determination, the facility must impose one of the sanctions specified in
submit the following documents and paragraph (b) of this section if CMS
§ 413.198 [Amended] data for consideration by the Secretary: finds that—
4. In § 413.198(a), the phrase (1) The supplier fails to participate in
‘‘approved under subpart U of part (1) Certification by the State agency
the activities and pursue the goals of the
405,’’ is revised to read ‘‘under part referred to in § 488.12 of this part. ESRD network that is designated to
494’’. (2) Data furnished by ESRD network encompass the supplier’s geographic
organizations and recommendations of area; and
PART 414—PAYMENT FOR PART B the Public Health Service concerning (2) This failure does not jeopardize
MEDICAL AND OTHER HEALTH the facility’s contribution to the ESRD patient health and safety.
SERVICES services of the network. (b) Alternative sanctions. The
1. Part 414 is amended as follows: (3) Data concerning the facility’s alternative sanctions that CMS may
1a. The authority citation for part 414 compliance with professional norms apply in the circumstances specified in
continues to read as follows: and standards. paragraph (a) of this section include the
following:
Authority: Secs. 1102, 1871, and 1881(b)(1) (4) Data pertaining to the facility’s (1) Denial of payment for services
of the Social Security Act (42 U.S.C. 1302, qualifications for approval or for any
1395hh, and 1395rr(b)(1)). furnished to patients first accepted for
expansion of services. care after the effective date of the
§ 414.330 [Amended] * * * * * sanction as specified in the sanction
2. In § 414.330(a)(2)(iii)(B), the 3. A new subpart H, consisting of notice.
reference ‘‘subpart U of part 405’’ is §§ 488.604, 488.606, 488.608, and (2) Reduction of payments, for all
revised to read ‘‘part 494’’; and in ESRD services furnished by the
488.610, is added to read as follows:
§ 414.330(a)(2)(iii)(B)(l), the reference to supplier, by 20 percent for each 30-day
‘‘subpart U’’ is changed to read ‘‘part Subpart H—Termination of Medicare period after the effective date of the
494’’. Coverage and Alternative Sanctions for End sanction.
3. In § 414.330(a)(2)(iii)(B)(1) the Stage Renal Disease (ESRD) Facilities (3) Withholding of all payments,
references ‘‘subpart U’’ are revised to Sec. without interest, for all ESRD services
read ‘‘part 494’. 488.604 Termination of Medicare coverage. furnished by the supplier to Medicare
4. In § 414.330(a)(2)(iii)(B)(7) the 488.606 Alternative sanctions. beneficiaries.
references ‘‘subpart U’’ are revised to 488.608 Notice of alternative sanction and (c) Duration of alternative sanction.
read ‘‘part 494’. appeal rights: Termination of coverage. An alternative sanction remains in effect
5. Section 414.330(a)(2)(iii)(C) is 488.610 Notice of appeal rights: Alternative until CMS finds that the supplier is in
added to read as follows: sanctions. substantial compliance with the
requirement to cooperate in the network Subpart C—Patient Care (b) Scope. The provisions of this part
plans and goals, or terminates coverage 494.70 Condition: Patient rights. establish the conditions for coverage of
of the supplier’s services for lack of 494.80 Condition: Patient assessment. services under Medicare and are the
compliance. 494.90 Condition: Patient plan of care. basis for survey activities for the
494.100 Condition: Care at home. purpose of determining whether an
§ 488.608 Notice of alternative sanction 494.110 Condition: Quality assessment and ESRD facility’s services may be covered.
and appeal rights: Termination of coverage. performance improvement.
(a) Notice of alternative sanction. 494.120 Condition: Special purpose renal § 494.10 Definitions.
CMS gives the supplier and the general dialysis facilities.
As used in this part—
public notice of the alternative sanction 494.130 Condition: Laboratory services.
Dialysis facility means an entity that
and of the effective date of the sanction. Subpart D—Administration provides (1) outpatient maintenance
The effective date of the alternative 494.140 Condition: Personnel dialysis services; or (2) home dialysis
sanction is at least 30 days after the date qualifications. training and support services; or (3)
of the notice. 494.150 Condition: Medical director. both. A dialysis facility may be an
(b) Appeal rights. Termination of 494.160 Condition: Relationship with the independent or hospital-based unit (as
Medicare coverage of a supplier’s ESRD ESRD network. described in § 413.174(b) and (c) of this
services because the supplier no longer 494.170 Condition: Medical records.
chapter), or a self-care dialysis unit that
meets the conditions for coverage of its 494.180 Condition: Governance.
furnishes only self-dialysis services.
services is an initial determination Authority: Secs. 1102 and 1871 of the
Social Security Act (42 U.S.C. 1302 and
Discharge means the termination of
appealable under part 498 of this patient care services by a dialysis
subchapter. 1395hh).
facility.
§ 488.610 Notice of appeal rights: Subpart A—General Provisions Furnishes directly means the ESRD
Alternative sanctions. facility provides the service through its
§ 494.1 Basis and scope. own staff and employees or through
If CMS proposes to apply an
(a) Statutory basis. This part is based individuals who are under direct
alternative sanction specified in
on the following provisions: contract to furnish these services
§ 488.606(b), the following rules apply:
(1) Section 299I of the Social Security personally for the facility.
(a) CMS gives the facility notice of the
Amendments of 1972 (Pub. L. 92–603), Home dialysis means dialysis
proposed alternative sanction and 15
which extended Medicare coverage to performed at home by an ESRD patient
days in which to request a hearing.
(b) If the facility requests a hearing, insured individuals, their spouses, and or caregiver who has completed an
CMS provides an informal hearing by a their dependent children with ESRD appropriate course of training as
CMS official who was not involved in who require dialysis or transplantation. described in § 494.100(a) of this part.
(2) Section 1138(a)(1)(B) of the Act, Interdisciplinary team means the
making the appealed decision.
(c) During the informal hearing, the which requires hospitals to be members group of persons, specified § 494.80 of
facility— and abide by the rules and requirements this part, responsible for providing
(1) May be represented by counsel; of the Organ Procurement and patient care to each dialysis patient.
(2) Has access to the information on Transplantation Network. Self-dialysis means dialysis
which the allegation was based; and (3) Section 1861(e)(9) of the Act,
performed with little or no professional
(3) May present, orally or in writing, which requires hospitals to meet such
assistance by an ESRD patient or
evidence and documentation to refute other requirements as the Secretary
caregiver who has completed an
the finding of failure to participate in finds necessary in the interest of health
appropriate course of training as
network activities and pursue network and safety of individuals who are
specified in § 494.100(a) of this part.
goals. furnished services in the institution.
Transfer means a temporary or
(d) If the written decision of the (4) Section 1861(s)(2)(F) of the Act,
permanent move of a patient from one
informal hearing supports application of which describes ‘‘medical and other
dialysis facility to another that requires
the alternative sanction, CMS provides health services’’ covered under
a transmission of the patient’s medical
the facility and the public, at least 30 Medicare to include home dialysis
record to the facility receiving the
days before the effective date of the supplies and equipment, self-care home
patient.
alternative sanction, a written notice dialysis support services, and
that specifies the effective date and the institutional dialysis services and § 494.20 Condition: Compliance with
reasons for the alternative sanction. supplies. Federal, State, and local laws and
1. Part 494 is added to read as follows: (5) Section 1862(a) of the Act, which regulations.
specifies exclusions from coverage. The facility and its staff must operate
PART 494—CONDITIONS FOR COVERAGE (6) Section 1881 of the Act, which
FOR END STAGE RENAL DISEASE
and furnish services in compliance with
authorizes Medicare coverage and applicable Federal, State, and local laws
FACILITIES payment for the treatment of ESRD in and regulations pertaining to licensure,
Subpart A—General Provisions approved facilities, including staff licensure and other personnel staff
Sec. institutional dialysis services, qualifications, fire safety, equipment,
494.1 Basis and scope. transplantation services, self-care home building codes, drugs, medical device
494.10 Definitions. dialysis services, and the administration usage, and any other relevant health and
494.20 Condition: Compliance with of recombinant epoetin alpha (EPO). safety requirements.
Federal, State, and local laws and (7) Section 12(d) of the National
regulations. Technology Transfer and Advancement Subpart B—Patient Safety
Subpart B—Patient Safety Act of 1995 (Pub. L. 104–113), which
requires Federal agencies to achieve § 494.30 Condition: Infection control.
494.30 Condition: Infection control.
494.40 Condition: Water quality. greater reliance on voluntary standards The dialysis facility must provide and
494.50 Condition: Reuse of hemodialyzers and emphasize, where possible, the use monitor a sanitary environment to
and bloodlines. of standards developed by private, minimize the transmission of infectious
494.60 Condition: Physical environment. consensus organizations. agents within and between the unit and
any adjacent hospital or other public (c) Standard: Monitoring. The facility are incorporated by reference.
areas. must— Incorporation by reference of the AAMI
(a) Standard: Procedures for infection (1) Analyze and document the Dialysate for Hemodialysis was
control. The facility must demonstrate incidence of infection to identify trends approved by the Director of the Federal
that it follows standard infection control and establish baseline information on Register in accordance with 5 U.S.C.
precautions by implementing— infection incidence; and 552(a) and 1 CFR part 51.3
(1) The ‘‘Recommended Infection (2) Develop recommendations to (ii) Chemical analysis of water purity
Control Practices for Hemodialysis minimize infection transmission and must be done at least once a year and
Units at a Glance,’’ with the exception take actions to reduce future incidents. when—
of screening for Hepatitis C, found in (d) Standard: Reporting. The facility (A) The system is installed;
‘‘Recommendations for Preventing must report incidences of (B) Membranes are replaced, if using
Transmission of Infections Among communicable diseases as required by a reverse osmosis system;
Chronic Hemodialysis Patients’ Federal, State, and local regulations. (C) Seasonal variations in source
Morbidity and Mortality Weekly Report, water suggest worsening water quality;
volume 50 number RR05, April 27, § 494.40 Condition: Water quality. (D) Reverse osmosis rejection rates,
2001, pages 20 and 21, developed by the The facility must be able to which are monitored daily using
Centers for Disease Control and demonstrate the following: continuous-reading monitors that
(a) Standard: Water purity. Water measure product water conductivity,
Prevention, which are incorporated by
used for dialysis meets the following fall below 90 percent.
reference, to prevent and control cross-
water quality standards and equipment (b) Standard: Reverse osmosis or
contamination and the spread of deionization. Each water treatment
infectious agents. Incorporation by requirements of the Association for the
Advancement of Medical system must include reverse osmosis
reference of the CDC ‘‘Recommended membranes or a deionization
Infection Control Practices for Instrumentation (AAMI) published in
‘‘Water Treatment Equipment for component with resistivity monitors.
Hemodialysis Units at a Glance,’’ was (c) Standard: Chlorine/chloramines.
approved by the Director of the Federal Hemodialysis Applications,’’ ANSI/
AAMI RD62: 2001, which are The facility must ensure, on a daily
Register in accordance with 5 U.S.C. basis, that the source water does not
552(a) and 1 CFR part 51.1 incorporated by reference. Incorporation
by reference of the AAMI Water contain chlorine/chloramines or the
(2) Patient isolation procedures to facility must ensure that—
minimize the spread of infectious agents Treatment Equipment for Hemodialysis
(1) The water treatment system
and communicable diseases; and Applications, was approved by the
includes a component or carbon tank
(3) Maintaining procedures, in Director of the Federal Register in
which removes chlorine/chloramine
accordance with applicable State and accordance with 5 U.S.C. 552(a) and 1
along with a backup component or
local laws and accepted public health CFR part 51.2
second carbon tank for chlorine/
procedures, for the— (1) Incorporated water quality
chloramine removal; and
(i) Handling, storage, and disposal of requirements are those listed in (2) The water from the exit port of the
potentially infectious waste; and sections— first component or carbon tank which
(ii) Cleaning and disinfection of (i) 4.2.1 and 5.2.1, Water Bacteriology; removes chlorine/chloramine is tested
contaminated surfaces, medical devices, (ii) 4.2.2 and 5.2.2 Maximum Level of for chlorine/chloramine levels, at a
and equipment. Chemical Contaminants; and minimum, before each patient shift or
(b) Standard: Oversight. The facility (iii) 4.3, Water Treatment Equipment every 4 hours, whichever is shorter,
must— requirements. during operation of the water treatment
(1) Monitor and implement biohazard (2) The requirements for frequency of system.
and infection control policies and water purity testing to insure meeting (i) If the test results are greater than
activities within the dialysis unit; and the AAMI limits specified in paragraphs 0.50 mg/L for free chlorine or 0.10 mg/
(2) Designate a registered nurse as the (a)(1)(i) and (ii) of this section are as L for chloramines from the port of the
infection control or safety officer, follows: initial component or carbon tank then
responsible for— (i) Bacteria and bacterial endotoxin the second component or carbon tank
(i) Maintaining current infection levels of water/dialysate must be which removes chlorine/chloramine
control information including the most monitored— must be tested; and
current Centers for Disease Control and (A) In established systems at least (ii) If the test results from the last
Prevention guidelines for the proper monthly; component or carbon tank are greater
techniques in the use of vials and (B) In newly-installed systems at least than the parameters for chlorine or
ampules containing medication; weekly until an established pattern of chloramine specified in paragraph
(ii) Reporting infection control issues compliance can be demonstrated; (c)(2)(i) of this section the facility
to the dialysis facility’s chief executive (C) In accordance with the must—
officer or administrator (see § 494.180(a) requirements of AAMI published in (A) Immediately terminate dialysis
of this part) and the quality ‘‘Dialysate for Hemodialysis,’’ ANSI/ treatment to protect patients from
improvement committee; and AAMI RD52:2004 section 7.2.1, which exposure to chlorine/chloramine;
(iii) Making recommendations
2 This publication is available for inspection at
regarding infection control training and 3 This publication is available for inspection at
the CMS Information Resource Center, 7500 the CMS Information Resource Center, 7500
improvements. Security Boulevard, Central Building, Baltimore, Security Boulevard, Central Building, Baltimore,
MD and at the National Archives and Records MD and at the National Archives and Records
1 This publication is available for inspection at Administration (NARA). For availability of this Administration (NARA). For availability of this
the CMS Information Resource Center, 7500 material at NARA, call 202–741–6030, or go to material at NARA, call 202–741–6030, or got to
Security Boulevard, Central Building, Baltimore, http://www.archives.gov./federal_register/ http://www.archives.gov./federal_register/
MD and at the National Archives and Records code_of_federal_regulations/ibr_locations.html. code_of_federal_regulations/ibr_locations.html.
Administration (NARA). For availability of this Copies may be purchased from the Association for Copies may be purchased from the Association for
material at NARA, call 202–741–6030, or got to the Advancement of Medical Instrumentation, 3300 the Advancement of Medical Instrumentation, 3300
http://www.archives.gov./federal_register/code Washington Boulevard, Suite 400, Arlington, VA Washington Boulevard, Suite 400, Arlington, VA
lowbar;of_federal_regulations/ibr_locations.html. 22201–4598. 22201–4598.
(B) Immediately notify the medical Register in accordance with 5 U.S.C. emergency equipment, dialysis
director; and 552(a) and 1 CFR part 51.4 machines and equipment, and the water
(C) Take corrective action. (2) Reprocess hemodialyzers and treatment system) are maintained and
(d) Standard: Corrective action plan. bloodlines—(i) By following the operated in accordance with the
Water testing results including, but not manufacturer’s recommendations; or manufacturer’s recommendations.
limited to, chemical, microbial, and (ii) Using an alternate method and (c) Standard: Patient care
endotoxin levels which meet AAMI maintaining documented evidence that environment. (1) The space for treating
action levels or deviate from the AAMI the method is safe and effective. each patient must be sufficient to
standards must be addressed with a (3) Not expose hemodialyzers to more provide needed care and services,
corrective action plan that ensures than one chemical germicide, other than prevent cross-contamination, and to
patient safety. bleach, during the life of the dialyzer. accommodate medical emergency
(e) Standard: Adverse events. A All hemodialyzers must be discarded equipment and staff.
dialysis facility must maintain active before a different chemical germicide is (2) The dialysis facility must—
surveillance of patient reactions during used in the facility. (i) Maintain a temperature within the
and following dialysis. When clinically (c) Standard: Monitoring, evaluation, facility that is comfortable for the
indicated (for example, after adverse and reporting requirements for the reuse majority of its patients; and
patient reactions) the facility must — of hemodialyzers and bloodlines. In (ii) Make reasonable accommodations
addition to the requirements for for the patients who are not comfortable
(1) Obtain blood and dialysate
hemodialyzer and bloodline reuse at the temperature that is comfortable
cultures;
specified in paragraphs (a) and (b) of for the majority.
(2) Undertake evaluation of the water this section, the dialysis facility must
purification system; and (d) Standard: Emergency
adhere to the following: preparedness. The dialysis facility must
(3) Take corrective action. (1) Monitor patient reactions during implement processes and procedures to
(f) Standard: Unused bicarbonate. and following dialysis. manage medical and nonmedical
Once mixed, bicarbonate concentrate (2) When clinically indicated (for emergencies that are likely to threaten
must be used within the timeframe example, after adverse patient the health or safety of the patients, the
specified by the manufacturer of the reactions), the facility must— staff, or the public. These emergencies
concentrate. (i) Obtain blood and dialysate include, but are not limited to, fire,
cultures; and equipment or power failures, care-
§ 494.50 Condition: Reuse of
hemodialyzers and bloodlines.
(ii) Undertake evaluation of its related emergencies, water supply
dialyzer reprocessing and water interruption, and natural disasters likely
The dialysis facility that reuses purification system. When this
hemodialyzers or bloodlines must meet to occur in the facility’s geographic area.
evaluation suggests a cluster of adverse (1) Emergency preparedness of staff.
the requirements of this section. Failure patient reactions is associated with
to meet any of these requirements The dialysis facility must provide
hemodialyzer reuse, the facility must appropriate training and orientation in
constitutes grounds for denial of suspend reuse of hemodialyzers until it
payment for the dialysis treatment emergency preparedness to the staff.
is satisfied the problem has been Staff training must be provided and
affected and termination from corrected.
participation in the Medicare program. evaluated at least annually and include
(iii) Report the adverse outcomes to the following:
(a) Standard: General requirements the FDA and other Federal, State or
for the reuse of hemodialyzers and (i) Ensuring that staff can demonstrate
local government agencies as required a knowledge of emergency procedures,
bloodlines. Certain hemodialyzers and by law.
bloodlines— including informing patients of—
§ 494.60 Condition: Physical environment. (A) What to do;
(1) May be reused for certain patients
The dialysis facility must be designed, (B) Where to go;
with the exception of Hepatitis B
constructed, equipped, and maintained (C) Whom to contact if an emergency
positive patients;
to provide dialysis patients, staff, and occurs while the patient is not in the
(2) Must be reused only for the same dialysis facility; and
patient; and the public a safe, functional, and
comfortable treatment environment. (D) How to disconnect themselves
(3) Must be labeled for multiple reuse from the dialysis machine if an
in accordance with the premarket (a) Standard: Building. The building
in which dialysis services are furnished emergency occurs.
notification provisions of section 501(k) (ii) Ensuring that, at a minimum,
of the Food, Drug, and Cosmetics Act must be constructed and maintained to
ensure the safety of the patients, the patient care staff maintain current CPR
and 21 CFR 876.5860. certification; and
(b) Standard: Reprocessing staff, and the public.
(b) Standard: Equipment (iii) Ensuring that nursing staff are
requirements for the reuse of properly trained in the use of emergency
maintenance. The dialysis facility must
hemodialyzers and bloodlines. A equipment and emergency drugs;
implement and maintain a program to
dialysis facility that reuses (2) Emergency preparedness patient
ensure that all equipment (including
hemodialyzers and bloodlines must training. The facility must provide
adhere to the following reprocessing 4 This publication is available for inspection at appropriate orientation and training to
guidelines: the CMS Information Resource Center, 7500 patients, including the areas specified in
(1) Meet the requirements of AAMI Security Boulevard, Central Building, Baltimore, paragraph (d)(1)(i) of this section.
published in ‘‘Reuse of Hemodialyzers,’’ MD and at the National Archives and Records
Administration (NARA). For availability of this
(3) Emergency equipment and plans.
third edition, ANSI/AAMI RD47:2002/ material at NARA, call 202–741–6030, or got to: Emergency equipment, including, but
A1:2003, which is incorporated by http://www.archives.gov./federal_register/ not limited to, oxygen, airways, suction,
reference. Incorporation by reference of code_of_federal_regulations/ibr_locations.html. defibrillator, artificial resuscitator, and
the ‘‘Reuse of Hemodialyzers, third Copies may be purchased from the Association for
the Advancement of Medical Instrumentation, 3300
emergency drugs, must be on the
edition, RD47:2002/A1:2003’’ was Washington Boulevard, Suite 400, Arlington, VA premises at all times and immediately
approved by the Director of the Federal 22201–4598. available. The facility must—
(i) Have a plan to obtain emergency intermittent peritoneal dialysis, the patient for ESRD, a social worker,
medical system assistance when continuous ambulatory peritoneal and a dietitian, is responsible for
needed; and dialysis, continuous cycling peritoneal providing each patient with an
(ii) Evaluate at least annually the dialysis), and in-facility hemodialysis; individualized and comprehensive
effectiveness of emergency and disaster (7) Be informed of facility policies assessment of his or her needs. The
plans and update them as necessary. regarding patient care, including, but comprehensive assessment must be
(e) Standard: Fire safety. (1) The not limited to, isolation of patients; used to develop the patient’s treatment
dialysis facility must meet applicable (8) Be informed of facility policies plan and expectations for care.
provisions of the 2000 edition of the regarding the reuse of dialysis supplies, (a) Standard: Assessment criteria. The
Life Safety Code of the National Fire including hemodialyzers; patient’s comprehensive assessment
Protection Association (which is (9) Be informed by a physician of his must include, but is not limited to, the
incorporated by reference in or her own medical status as following:
§ 403.744(a)(1)(i) of this chapter). documented in the patient’s medical (1) Evaluation of current health status
(2) Chapter 5 of the 2000 edition of record unless the medical record and medical condition, including co-
the Life Safety Code does not apply to contains a documented contraindication morbid conditions.
a dialysis facility. to do so; (2) Evaluation of the appropriateness
(3) If CMS finds that a State has a fire (10) Be informed of services available of the dialysis prescription, blood
and safety code imposed by State law in the facility and charges for services pressure, and fluid management needs.
that adequately protects a dialysis not covered under Medicare; (3) Laboratory profile and medication
facility’s patients, CMS may allow the (11) Receive the necessary services history.
State survey agency to apply the State’s outlined in the patient plan of care (4) Evaluation of factors associated
fire and safety code instead of the Life described in § 494.90 of this part; with anemia, such as hematocrit,
(12) Be informed of the rules and hemoglobin, iron stores, and potential
Safety Code.
(4) After consideration of State survey expectations of the facility regarding treatment plans for anemia, including
agency recommendations, CMS may patient conduct and responsibilities; administration of erythropoietin.
(13) Be informed of the facility’s (5) Evaluation of factors associated
waive, for appropriate periods, specific
internal grievance process; with renal bone disease.
provisions of the Life Safety Code if the (6) Evaluation of nutritional status.
following requirements are met: (14) Be informed of external grievance
(7) Evaluation of psychosocial needs.
(i) The waiver would not adversely mechanisms and processes, including (8) Evaluation of dialysis access type
affect the health and safety of the how to contact the ESRD Network and and maintenance (for example,
dialysis facility’s patients; and the State survey agency; arteriovenous fistulas, arteriovenous
(ii) Rigid application of specific (15) Be informed of his or her right to grafts, and peritoneal catheters).
provisions of the Life Safety Code file internal grievances or external (9) Evaluation of the patient’s ability,
would result in an unreasonable grievances or both without reprisal or interests, preferences, and goals,
hardship for the dialysis facility. denial of services; and including level of participation in the
(16) Be informed that he or she may dialysis care process; modality and
Subpart C—Patient Care file internal or external grievances, setting, for example, home dialysis,
personally, anonymously or through a including hemodialysis or peritoneal
§ 494.70 Condition: Patients’ rights.
representative of the patient’s choosing. dialysis; and expectations for care
The dialysis facility must inform (b) Standard: Right to be informed outcomes.
patients (or their representatives) of regarding the facility’s discharge and (10) Evaluation of suitability for a
their rights (including their privacy transfer policies. The patient has the transplantation referral, based on
rights) and responsibilities when they right to— criteria developed by the prospective
begin their treatment and must protect (1) Be informed of the facility’s transplantation center and its
and provide for the exercise of those policies for transfer, discharge, and surgeon(s). If the patient is not suitable
rights. discontinuation of services to patients; for transplantation referral, the basis for
(a) Standard: Patients’ rights. The and nonreferral must be documented in the
patient has the right to— (2) Receive written notice 30 days in patient’s medical record.
(1) Respect, dignity, and recognition advance of the facility reducing or (11) Evaluation of family and other
of his or her individuality and personal terminating ongoing care after following support systems.
needs, and sensitivity to his or her the procedure described in § 494.180(f) (12) Evaluation of current patient
psychological needs and ability to cope of this part. In the case of immediate physical activity level.
with ESRD; threats to the health and safety of others, (13) Evaluation of vocational and
(2) Receive all information in a way a shortened discharge procedure may be physical rehabilitation status and
that he or she can understand; allowed. potential.
(3) Privacy and confidentiality in all (c) Standard: Posting of rights. The (b) Standard: Frequency of
aspects of treatment; dialysis facility must prominently assessment for new patients.
(4) Privacy and confidentiality in display a copy of the patient’s rights in (1) An initial comprehensive
personal medical records; the facility, including the current State assessment must be conducted within
(5) Be informed about and participate, agency and ESRD network telephone 20 calendar days after the first dialysis
if desired, in all aspects of his or her complaint numbers, where it can be treatment.
care, including advance directives, and easily seen and read by patients. (2) A follow up comprehensive
be informed of the right to refuse reassessment must occur within 3
treatment and to refuse to participate in § 494.80 Condition: Patient assessment. months after the completion of the
experimental research; The facility’s interdisciplinary team, initial assessment to provide
(6) Be informed about all treatment consisting of, at a minimum, the patient information to adjust the patient’s plan
modalities and settings, including but (if the patient chooses) or the patient’s of care specified in § 494.90 of this part.
not limited to, transplantation, home designee, a registered nurse, a (c) Standard: Assessment of treatment
dialysis modalities (home hemodialysis, nephrologist or the physician treating prescription.
The adequacy of the patient’s dialysis must be measured at least monthly. If a (4) The dialysis facility must ensure
prescription, as described in patient has hemoglobin less than 11 gm/ that all dialysis patients are seen by a
§ 494.90(a)(1) of this part, must be dL or hematocrit of less than 33 percent, physician providing the ESRD care at
assessed on an ongoing basis as follows: the dialysis facility must conduct an least monthly, as evidenced by a
(1) Hemodialysis patients. At least evaluation to determine whether the monthly progress note placed in the
monthly by calculating delivered Kt/V patient is an erythropoietin candidate. medical record, and periodically, while
or an equivalent measure. For a home dialysis patient, the facility the hemodialysis patient is receiving in-
(2) Peritoneal dialysis patients. At must evaluate whether the patient can facility dialysis.
least every 4 months by calculating safely, aseptically, and effectively (c) Standard: Transplantation referral
delivered weekly Kt/V or an equivalent administer erythropoietin and store tracking. The interdisciplinary team
measure. erythropoietin under refrigeration. The must track the results of each kidney
(d) Standard: Patient reassessment. In patient’s response to erythropoietin, transplant center referral and must
accordance with the standards specified including blood pressure levels and monitor the status of any facility
in paragraphs (a)(1) through (a)(13) of utilization of iron stores, must be patients who are on the transplant wait
this section, a comprehensive monitored on a routine basis. list. The team must communicate with
reassessment of each patient and a (4) Vascular access. The the transplant center regarding patient
revision of the plan of care must be interdisciplinary team must provide the transplant status at least quarterly or
conducted— necessary care and services to achieve more frequently if necessary.
(1) At least annually for stable and sustain vascular access. The (d) Standard: Patient education and
patients; and hemodialysis patient must be evaluated training. The patient care plan must
(2) At least monthly for unstable for the appropriate vascular access type, include, as applicable, education and
patients including, but not limited to, taking into consideration co-morbid training for patients and family
patients with— conditions and other risk factors. The members or caregivers or both, in
(i) Extended or frequent patient’s vascular access must be aspects of the dialysis experience,
hospitalizations; monitored to prevent access failure, dialysis management, quality of life,
(ii) Marked deterioration in health including monitoring of ateriovenous rehabilitation, and transplantation.
status; grafts and fistulae for stenosis.
(iii) Significant change in (5) Transplantation status. When the § 494.100 Condition: Care at home.
psychosocial needs; or patient is a transplantation referral A dialysis facility that is certified to
(iv) Poor nutritional status, with candidate, the interdisciplinary team provide services to home patients must
unmanaged anemia and inadequate must develop plans for pursuing ensure, through its interdisciplinary
dialysis. transplantation. The patient’s plan of team that home dialysis services are at
§ 494.90 Condition: Patient plan of care. care must include documentation of least equivalent to those provided to in-
The interdisciplinary team must the— facility patients.
develop and implement a written, (i) Plan for transplantation, if the (a) Standard: Training. The
individualized comprehensive plan of patient accepts to transplantation interdisciplinary team must provide
care that specifies the services necessary referral; training to the home dialysis patient, the
to address the patient’s needs, as (ii) Patient’s decision, if the patient is designated caregiver, or self-dialysis
identified by the comprehensive a transplantation referral candidate but patient before the initiation of home
assessment and changes in the patient’s declines the transplantation referral; or dialysis or self-dialysis (as defined in
condition, and must include measurable (iii) Reason(s) for the patient’s § 494.10 of this part) and when the
and expected outcomes and estimated nonreferral as a transplantation home dialysis caregiver or home
timetables to achieve these outcomes. candidate as documented in accordance dialysis modality changes. The
The outcomes specified in the patient with § 494.80(a)(10) of this part. training—
plan of care must allow the patient to (6) Rehabilitation status. The (1) Must be provided by a dialysis
achieve current evidence-based interdisciplinary team must provide the facility that is approved to provide
community-accepted standards. necessary care and services for the home dialysis services;
(a) Standard: Development of patient patient to achieve and sustain an (2) For self-care, must be conducted
plan of care. The interdisciplinary team appropriate level of productive activity, by a registered nurse who meets the
must develop a plan of care for each including vocational, as desired by the requirements of § 494.140(b)(2) of this
patient. The plan of care must address, patient, including the educational needs part; and
but not be limited to, the following: of pediatric patients (patients under the (3) Must be conducted for each home
(1) Dose of dialysis. The age of 18 years). patient and address the specific needs of
interdisciplinary team must provide the (b) Standard: Implementation of the the patient, in the following areas:
necessary care and services to achieve patient plan of care. (i) The nature and management of
and sustain the prescribed dose of (1) The patient’s plan of care— ESRD;
dialysis. (i) Must be completed by the (ii) The full range of techniques
(2) Nutritional status. The interdisciplinary team; associated with treatment modality
interdisciplinary team must provide the (ii) Must be signed by the patient or selected, including effective use of
necessary care and services to achieve the patient’s designee. dialysis supplies and equipment in
and sustain an effective nutritional (2) Implementation of the plan of care achieving and delivering the physician’s
status. A patient’s albumin level must must begin within 10 calendar days prescription of Kt/V or URR, and
be measured at least monthly. after completion the patient assessment effective erythropoietin administration
(3) Anemia. The interdisciplinary as specified in § 494.80 of this part. (if prescribed) to achieve and maintain
team must provide the necessary care (3) If the expected outcome is not a hematocrit level of at least 33 percent
and services to achieve and sustain the achieved, the interdisciplinary team, or a hemoglobin level of 11 gm/dL;
expected hemoglobin/hematocrit level. must adjust the patient’s plan of care to (iii) Implementation of a nutritional
The patient’s hemoglobin/hematocrit achieve the specified goals. care plan;
(iv) How to achieve and maintain (vi) Purchasing, delivering, installing, improvements, and track performance to
emotional and social well-being; repairing and maintaining medically ensure that improvements are sustained
(v) How to detect, report, and manage necessary home dialysis supplies and over time. Each facility must participate
potential dialysis complications; equipment (including supportive in ESRD network activities and pursue
(vi) Availability of support resources equipment) prescribed by the attending network goals.
and how to access and use resources; physician. (c) Standard: Prioritizing
(vii) How to self-monitor health status (vii) Identifying a plan and arranging improvement activities. The dialysis
and record and report health status for emergency back-up dialysis services facility must set priorities for
information; when needed. performance improvement, considering
(viii) How to handle medical and non- (2) The dialysis facility must maintain prevalence and severity of identified
medical emergencies; a recordkeeping system that ensures problems and giving priority to
(ix) Infection control precautions; and continuity of care and patient privacy. improvement activities that affect
(x) Proper waste storage and disposal This includes items and services clinical outcomes or patient safety. The
procedures. furnished by durable medical facility must immediately correct any
(b) Standard: Home dialysis equipment (DME) suppliers referred to identified problems that threaten the
monitoring. The dialysis facility must— in § 414.330(a)(2) of this chapter. health and safety of patients.
(1) Document in the medical record
that the patient, the caregiver, or both § 494.110 Condition: Quality assessment § 494.120 Condition: Special purpose renal
received and demonstrated adequate and performance improvement. dialysis facilities.
comprehension of the training; The dialysis facility must develop, A special purpose renal dialysis
(2) Retrieve and review complete self- implement, maintain, and evaluate an facility is approved to furnish dialysis
monitoring data and other information effective, data-driven, interdisciplinary on a short-term basis at special
from self-care patients or their quality assessment and performance locations. Special purpose dialysis
designated caregiver(s) at least every 2 improvement program. The program facilities are divided into two categories:
months; and must reflect the complexity of the vacation camps (locations that serve
(3) Maintain this information in the dialysis facility’s organization and ESRD patients while the patients are in
patient’s medical record. services (including those services a temporary residence) and facilities
(c) Standard: Support services. provided under arrangement), and must established to serve ESRD patients
(1) A dialysis facility must furnish focus on indicators related to improved under emergency circumstances.
directly home dialysis support services health outcomes and the prevention and (a) Standard: Approval period. The
regardless of whether dialysis supplies reduction of medical errors. The dialysis period of approval for a special purpose
are provided by the dialysis facility or facility must maintain and demonstrate renal dialysis facility may not exceed 8
a durable medical equipment company, evidence of its quality improvement and months in any 12-month period.
that include, but are not limited to, the performance improvement program for (b) Standard: Service limitation.
following: review by CMS. Special purpose renal dialysis facilities
(i) Periodic monitoring of the patient’s (a) Standard: Program scope. (1) The are limited to areas in which there are
home adaptation, including visits to the program must include, but not be limited dialysis resources or access-to-
patient’s home by facility personnel in limited to, an ongoing program that care problems due to an emergency
accordance with the patient’s plan of achieves measurable improvement in circumstance. A special purpose renal
care. health outcomes and reduction of dialysis facility may provide services
(ii) Coordination of the home patient’s medical errors by using indicators or only to those patients who would
care by a member of the dialysis performance measures associated with otherwise be unable to obtain treatments
facility’s interdisciplinary team. improved health outcomes and with the in the geographic locality served by the
(iii) Development and periodic review identification and reduction of medical facility.
of the patient’s individualized errors.
comprehensive plan of care that (c) Standard: Scope of requirements.
(2) The dialysis facility must measure,
specifies the services necessary to (1) Scope of requirements for a vacation
analyze and track quality indicators or
address the patient’s needs and meet the camp. A vacation camp that provides
other aspects of performance that the
measurable and expected outcomes as dialysis services must be operated under
facility adopts or develops that reflect
specified in § 494.90 of this part. the direction of a certified renal dialysis
processes of care and facility operations.
(iv) Patient consultation with facility that assumes full responsibility
These performance components must
members of the interdisciplinary team, for the care provided to patients. A
influence or relate to the desired
as needed. special purpose renal dialysis facility
outcomes or be the outcomes
(v) Monitoring of the quality of water established as a vacation camp must
themselves. The program must include,
used by home hemodialysis patients in comply with the following conditions
but not be limited to, the following:
accordance with the requirements for coverage—
(i) Adequacy of dialysis.
specified in § 494.40(a)(1)(i) and (ii) of (ii) Nutritional status. (i) Infection control at § 494.30 of this
this part and conducting an onsite (iii) Anemia management. part;
evaluation of the water system. The (iv) Vascular access. (ii) Water quality at § 494.40 of this
dialysis facility must correct the water (v) Medical injuries and medical part (except as provided in paragraph
quality of the home hemodialysis errors identification. (c)(1)(viii) of this section;
patient, and if necessary, arrange for (vi) Hemodialyzer reuse program, if (iii) Reuse of hemodialyzers at
backup dialysis until the problem is the facility reuses hemodialyzers. § 494.50 of this part (if reuse is
corrected if— (vii) Patient satisfaction and performed);
(A) Analysis of the water quality grievances. (iv) Patients’ rights and posting of
indicates contamination; or (b) Standard: Monitoring performance patients’ rights) §§ 494.70(a) and (c) of
(B) The home hemodialysis patient improvement. The dialysis facility must this part;
demonstrates clinical symptoms continuously monitor its performance, (v) Laboratory services at § 494.130 of
associated with water contamination. take actions that result in performance this part;
(vi) Medical director responsibilities competencies necessary to serve (3) Have a minimum of one year’s
for staff education and patient care collectively the comprehensive needs of professional work experience in clinical
policies and procedures at § 494.150(c) the patients. The dialysis facility’s staff nutrition as a registered dietitian.
and (d) of this part; must have the ability to demonstrate (d) Standard: Social worker. The
(vii) Medical records at § 494.170 of and sustain the skills needed to perform facility must have a social worker
this part; and the specific duties of their positions. who—
(viii) When portable home water (a) Standard: Medical director. (l) The (1) Holds a master’s degree in social
treatment systems are used in place of medical director must be a physician work from a school of social work
a central water treatment system, the who has completed a board approved accredited by the Council on Social
facility may adhere to § 494.100(c)(1)(v) training program in nephrology and has Work Education; and
(home monitoring of water quality) of at least 12 months of experience (2) Meets the practice requirements
this part, in place of § 494.40 (water providing care to patients receiving for social work practice in the State in
quality) of this part. dialysis. which he or she is employed.
(2) Scope of requirements for an (e) Standard: Patient care dialysis
(2) If a physician, as specified in
emergency circumstance facility. A technicians. Patient care dialysis
paragraph (a)(1) of this section, is not
special purpose renal dialysis facility technicians must—
available to direct a certified dialysis (1) Meet all applicable State
set up due to emergency circumstances facility, another physician may direct requirements for education, training,
may provide services only to those the facility, subject to the approval of credentialing, competency, standards of
patients who would otherwise be unable the Secretary. practice, certification, and licensure in
to obtain treatments in the geographic (b) Standard: Nursing services. (1) the State in which he or she is
areas served by the facility. These types Nurse manager. The facility must have employed as a dialysis technician; and
of special purpose dialysis facilities a nurse manager responsible for nursing (2) Have a high school diploma or
must additionally comply with the services in the facility who must— equivalency;
following conditions: (i) Be a full time employee of the (3) Have completed at least 3 months
(i) § 494.20 (compliance with Federal, facility; experience, following a training
State, and local laws and regulations). (ii) Be a registered nurse who meets program that is approved by the medical
(ii) § 494.60 (physical environment). the practice requirements of the State in director and governing body. This
(iii) § 494.70(a) through (c) (patient which he or she is employed; and experience must be under the direct
rights). (iii) Have at least 12 months of supervision of a registered nurse, and be
(iv) § 494.140 (personnel experience in clinical nursing, and an focused on the operation of kidney
qualifications). additional 6 months of experience in dialysis equipment and machines,
(v) § 494.150 (medical director). providing nursing care to patients on providing direct patient care, and
(vi) § 494.180 (governance). maintenance dialysis. communication and interpersonal skills
(d) Standard: Physician contact. The (2) Self-care training nurse. The nurse including patient sensitivity training
facility must contact the patient’s responsible for self-care training must— and care of difficult patients.
physician, prior to initiating dialysis in (i) Be a registered nurse who meets (f) Standard: Water treatment system
the special purpose renal dialysis the practice requirements of the State in technicians. Technicians who perform
facility, to discuss the patient’s current which he or she is employed; and monitoring and testing of the water
condition to assure care provided in the (ii) Have at least 12 months treatment system must complete a
special purpose renal dialysis facility is experience in providing nursing care training program that has been approved
consistent with the patient plan of care and an additional 3 months of by the medical director and the
(described in § 494.90 of this part). experience in the specific modality for governing body.
(e) Standard: Documentation. All which the nurse will provide self-care
patient care provided in the special § 494.150 Condition: Responsibilities of
training. the medical director.
purpose facility is documented and (3) Charge nurse. The charge nurse
forwarded to the patient’s dialysis The dialysis facility must have a
responsible for each shift must—
facility within 30 days of the last medical director who meets the
(i) Be a registered nurse or a practical
scheduled treatment in the special qualifications of § 494.140(a) of this part
nurse who meets the practice
purpose renal dialysis facility. to be responsible for the delivery of
requirements in the State in which he or
patient care and outcomes in the
§ 494.130 Condition: Laboratory services. she is employed; and
facility. Responsibilities include, but are
(ii) Have at least 12 months
The dialysis facility must provide or not limited to, the following:
experience in providing nursing care, (a) Quality assessment and
make available laboratory services
including 3 months of experience in performance improvement program.
(other than tissue pathology and
providing nursing care to patients on (b) Staff education, training, and
histocompatibility) to meet the needs of
maintenance dialysis. performance.
the ESRD patient. Any laboratory
(4) Staff nurse. Each nurse who (c) Policies and procedures. The
services, including tissue pathology and
provides care and treatment to patients medical director must—
histocompatibility, must be furnished
must be either a registered nurse or a (1) Participate in the development,
by or obtained from, a facility that meets
practical nurse who meets the practice periodic review and approval of a
the requirements for laboratory services
requirements in the State in which he or ‘‘patient care policies and procedures
specified in part 493 of this chapter.
she is employed. manual’’ for the facility; and
Subpart D—Administration (c) Standard: Dietitian. The facility (2) Ensure that—
must have a dietitian who must— (i) All policies and procedures
§ 494.140 Condition: Personnel (1) Be a registered dietitian with the relative to patient care and safety are
qualifications. Commission on Dietetic Registration; adhered to by all individuals who treat
The dialysis facility’s staff (employee (2) Meet the practice requirements in patients in the facility, including
or contractor) must meet the personnel the State in which he or she is attending physicians and nonphysician
qualifications and demonstrated employed; and providers; and
(ii) The interdisciplinary team than that required by State law or, in the (5) There is an approved written
adheres to the discharge and transfer absence of State law— training program specific to dialysis
policies and procedures specified in (1) Adults. 5 years from the date of the technicians that includes—
§ 494.180(f) of this part. patient’s discharge, transfer or death; or (i) Principles of dialysis;
(2) Minors. 3 years or until the patient (ii) Care of patients with kidney
§ 494.160 Condition: Relationship with the reaches legal age under State law, failure, including interpersonal skills;
ESRD network. whichever is longer, from the date of the (iii) Dialysis procedures and
The dialysis facility must cooperate patient’s discharge, transfer or death. documentation, including the initiation,
with the ESRD network designated for (d) Standard: Transfer of patient monitoring, and termination of dialysis;
its geographic area, in fulfilling the record information. When a dialysis (iv) Possible complications of dialysis;
terms of the Network’s current patient is transferred, the dialysis (v) Water treatment;
statement of work. facility releasing the patient must send (vi) Infection control; and
the patient’s medical record and other (vii) Safety; and
§ 494.170 Condition: Medical records. information necessary in the patient’s (viii) Dialyzer reprocessing, if
The dialysis facility must maintain care or treatment to the receiving facility applicable.
complete, accurate, and accessible within 1 working day of the transfer. (6) When State requirements meet or
records on all patients, including home exceed § 494.180(b)(5) the State
patients who elect to receive dialysis § 494.180 Condition: Governance. requirements must be met.
supplies and equipment from a supplier The ESRD facility is under the control (c) Standard: Medical staff
that is not a provider of ESRD services of an identifiable governing body, or appointments. The governing body—
and all other home dialysis patients designated person(s), with full legal (1) Is responsible for all medical staff
whose care is under the supervision of authority and responsibility for the appointments and credentialing,
the facility. governance and operation of the facility. including attending physicians,
(a) Standard: Protection of the The governing body adopts and enforces physician assistants, and nurse
patient’s record. The dialysis facility rules and regulations relative to its own practitioners; and
must— governance and to the health care and (2) Ensures that all medical staff who
(1) Safeguard patient records against safety of patients, to the protection of provide care in the facility are informed
loss, destruction, or unauthorized use. the patients’ personal and property of all facility policies and procedures,
(2) Keep confidential all information rights, and to the general operation of including the facility’s quality
contained in the patient’s record, except the facility. The governing body receives assessment and performance
when release is authorized pursuant to and acts upon recommendations from improvement program specified in
one of the following: the ESRD Network. § 494.110 of this part.
(i) The transfer of the patient to (a) Standard: Designating a chief (d) Standard: Furnishing services. The
another facility. executive officer or administrator. The governing body is responsible for
(ii) Certain exceptions provided for in governing body or designated person ensuring that the dialysis facility
the law. responsible must appoint an individual furnishes directly (see § 494.10 of this
(iii) Provisions allowed under third who serves as the dialysis facility’s chief part) services on its main premises or on
party payment contracts. executive officer or administrator who other premises that are contiguous with
(iv) Approval by the patient. exercises responsibility for the the main premises and are under the
(v) Inspection by authorized agents of management of the facility and the direction of the same professional staff
the Secretary, as required for the provision of all dialysis services, and governing body as the main
administration of the dialysis program. including, but not limited to— premises (except for services provided
(3) Obtain written authorization from (1) Staff appointments;
(2) Fiscal operations; under § 494.100 of this part).
the patient or legal representative before (e) Standard: Internal grievance
(3) The relationship with the ESRD
releasing information that is not process. The facility’s internal grievance
networks; and
authorized by law. (4) Allocation of necessary staff and process must be implemented so that
(b) Standard: Completion of patient other resources for the facility’s quality the patient may file a grievance with the
records and centralization of clinical assessment and performance facility without reprisal or denial of
information. improvement program described in services. The grievance process must
(1) Current medical records and those § 494.110 of this part. include—
of discharged patients must be (b) Standard: Adequate number of (1) A clearly explained procedure for
completed promptly. qualified and trained staff. The the submission of grievances;
(2) All clinical information pertaining governing body or designated person (2) Timeframes for reviewing the
to a patient must be centralized in the responsible must ensure that— grievance;
patient’s record. These records must be (1) An adequate number of qualified (3) A description of how the patient
maintained in a manner such that each personnel are present whenever patients or the patient’s designated
member of the interdisciplinary team are undergoing dialysis so that the representative will be informed of steps
has access to current information patient/staff ratio is appropriate to the taken to resolve the grievance.
regarding the patient’s condition and level of dialysis care given and meets (f) Standard: Discharge and transfer
prescribed treatment. the needs of patients; policies and procedures. The governing
(3) The dialysis facility must (2) A registered nurse is present in the body must ensure that all staff follow
complete, maintain, and monitor home facility at all times that patients are the facility’s patient discharge and
care patients’ records, including the being treated; transfer policies and procedures. The
records of patients who receive supplies (3) All employees have appropriate medical director ensures that no patient
and equipment from a durable medical orientation to the facility and their work is discharged or transferred from the
equipment supplier. responsibilities upon employment; facility unless—
(c) Standard: Record retention and (4) All employees have an (1) The patient or payer no longer
preservation. Patient records must be opportunity for continuing education reimburses the facility for the ordered
retained for a period of time not less and related development activities; and services;
(2) The facility ceases to operate; instructions for obtaining emergency (2) Be submitted electronically in the
(3) The transfer is necessary for the medical care. format specified by the Secretary;
patient’s welfare because the facility can (2) The dialysis facility must have (3) Include, but not be limited to—
no longer meet the patient’s available at the nursing/monitoring
documented medical needs; or station, a roster with the names of (i) Cost reports;
(4) The facility has reassessed the physicians to be called for emergencies, (ii) ESRD administrative forms;
patient and determined that the when they can be called, and how they (iii) Patient survival information; and
patient’s behavior is disruptive and can be reached.
abusive to the extent that the delivery of (iv) Existing ESRD clinical
(3) The dialysis facility must have an
care to the patient or the ability of the performance measures and any future
agreement with a hospital that can
facility to operate effectively is seriously clinical performance standards
provide inpatient care, other hospital
impaired, in which case the medical developed in accordance with the
services, and emergency medical care
director ensures that the patient’s National Technology Transfer and
which is available 24 hours a day, 7
interdisciplinary team— Advancement Act process adopted by
days a week. The agreement must—
(i) Documents the reassessments, the Secretary.
(i) Ensure that hospital services are
ongoing problem(s), and efforts made to (i) Standard: Disclosure of ownership.
available promptly to the dialysis
resolve the problem(s) and enters this In accordance with §§ 420.200 through
facility’s patients when needed.
documentation into the patient’s 420.206 of this chapter, the governing
(ii) Include reasonable assurances that
medical record; body must report ownership interests of
(ii) Obtains a written physician’s patients from the dialysis facility are
accepted and treated in emergencies. 5 percent or more to its State survey
order that must be signed by both the agency.
medical director and the patient’s (h) Standard: Furnishing data and
attending physician concurring with the information for ESRD program (Catalog of Federal Domestic Assistance
patient’s discharge or transfer from the administration. The dialysis facility Program No. 93.773, Medicare—Hospital
must furnish data and information to Insurance; and Program No. 93.774,
facility; Medicare—Supplementary Medical
(iii) Attempts to place the patient in CMS and at intervals as specified by the
Secretary. This information is used in a Insurance Program)
another facility and documents that
effort; and national ESRD information system and Approved: July 19, 2004.
(iv) Notifies the State survey agency in compilations relevant to program Tommy G. Thompson,
and the ESRD Network that services the administration, including claims Secretary.
area (where the facility is located) of the processing and reimbursement, quality
improvement, and performance Note: This document was received at the
involuntary transfer or discharge. Office of the Federal Register on January 25,
(g) Standard: Emergency coverage. (1) assessment. The data and information 2005.
The governing body is responsible for must—
ensuring that the dialysis facility (1) Be submitted at the intervals [FR Doc. 05–1622 Filed 1–28–05; 8:45 am]
provides patients and staff with written specified by the Secretary; BILLING CODE 4120–01–P

Proposed Rule: Medicare Conditions For Coverage For End-Stage Renal Disease Facilities

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Friday,

42 CFR Parts 400, 405, 410, et al.

All patients HBsAg, Anti-HBc (total) Anti-HBs*,

HBV susceptible, including non-re- HBsAg

Anti-HBs positive(>10 mIU/mL), anti- Anti-HBs

Anti-HBs and anti-HBc positive No additional HBV testing needed

Anti-HCV negative ALT Anti-HCV

transplantation program before skilled professionals. These 2. Nursing Services (Proposed

minimal education requirement is patients, including disruptive or average of 12 medications, which

Condition New provisions

B. ESRD Crosswalk (Cross Refers

Proposed conditions (part

Proposed conditions (part

Proposed conditions (part

Patient plan of care ........... 494.90(a)

transmitting the data and paying the

COST ESTIMATE FOR THE COLLECTION OF CPM DATA

The following chart provides an

OVERALL IMPACT OF THE PROPOSED RULE ON THE ECONOMY

Total impact on the economy ........................................................................................................................................... = +8,812,319

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