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Federal Register / Vol. 73, No.

5 / Tuesday, January 8, 2008 / Notices 1355

In 2008, a sample of 40 hospitals will The current data items will be Services (CMS), and Bureau of the
be selected for a pretest. These hospitals collected with significant additional Census. Data collected through the
will not be a probability sample, but details. Patient level data items to be NHDS are essential for evaluating health
instead will be intentionally selected to collected include personal identifiers status of the population, for the
include hospitals of differing size, such as Social Security number, name planning of programs and policy to
location and other characteristics and medical record number; clinical elevate the health status of the Nation,
related to their service and patient laboratory results such as hematocrit for studying morbidity trends, and for
clientele. and white blood cell count; and research activities in the health field.
In 2010, a redesigned NHDS will be financial billing and record data. The NHDS data have been used extensively
implemented and will consist of a survey includes detailed questions for
in the development and monitoring of
completely new sample of three modules: Acute myocardial
approximately 240 hospitals. The goals for the Year 2000 and 2010
infarction; infectious disease; and end of
redesigned NHDS will use a modified life issues. Facility level data items Healthy People Objectives. In addition,
two stage design. The first stage include demographic information, NHDS data provide annual updates for
sampling will be hospitals. The second clinical capabilities, and financial numerous tables in the Congressionally-
stage of sampling will be discharges. A information. mandated NCHS report, Health, United
stratified, random sample of 120 Users of NHDS data include, but are States. Other users of these data include
discharges is targeted within each not limited to the CDC; the universities, contract research
hospital. In the redesigned survey all Congressional Research Office; the organizations, many in the private
data will be abstracted by trained health Office of the Assistant Secretary for sector, foundations, and a variety of
care staff under contract. All data will Planning and Evaluation (ASPE); users in the print media. There is no
be obtained from hospital records and American Health Care Association, cost to respondents other than their time
charts and computer systems. Centers for Medicare and Medicaid to participate.

ESTIMATED ANNUALIZED BURDEN HOURS


Number of Response
Number of Hours per
Hospitals responses per burden
respondents response
respondent (hours)

Current NHDS:
Primary Procedure abstracting ................................................................. 13 250 6/60 325
Alternate (Census) Procedure (pulling & refiling records) ....................... 41 250 1/60 171
In-House Tape or Printout Hospital (programming) ................................. 29 12 13/60 75
Induction ................................................................................................... 10 1 2 20

Sub-total ............................................................................................ ........................ ........................ ........................ 591


Redesign HDS Pre-test:
Survey presentation to hospital ................................................................ 13 1 1 13
Facility questionnaire ................................................................................ 13 1 4.1 53
Sample discharges and obtain data ......................................................... 13 10 14/60 30
Debrief hospital staff ................................................................................. 13 1 1 13
Quality control ........................................................................................... 2 25 14/60 12

Sub-total ............................................................................................ ........................ ........................ ........................ 121


Redesign Survey 2010 & 2011:
Survey presentation to hospital ................................................................ 160 1 1 160
Facility questionnaire ................................................................................ 80 1 4.1 328
Sample discharges and obtain data ......................................................... 160 120 14/60 4,480
Pre-testing of new data elements ............................................................. 13 120 5/60 130
Quality control ........................................................................................... 3 25 14/60 18
Non-response study ................................................................................. 27 1 2 54

Sub-total ............................................................................................ ........................ ........................ ........................ 5,170

Total ........................................................................................... ........................ ........................ ........................ 5,882

Dated: December 27, 2007. DEPARTMENT OF HEALTH AND SUMMARY: This notice announces an
Maryam I. Daneshvar, HUMAN SERVICES administrative hearing to be held on
Acting Reports Clearance Officer, Centers for February 15, 2008, at the CMS San
Disease Control and Prevention. Centers for Medicare & Medicaid Francisco Regional Office, 90 7th Street,
[FR Doc. E8–51 Filed 1–7–08; 8:45 am] Services 5th Floor, Room 5A, San Francisco,
BILLING CODE 4163–18–P California 94103, to reconsider CMS’
Notice of hearing: Reconsideration of decision to disapprove California’s SPA
Disapproval of California’s State Plan 06–019B.
Amendment (SPA) 06–019B
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Closing Date: Requests to participate


AGENCY: Centers for Medicare & in the hearing as a party must be
Medicaid Services (CMS), HHS. received by the presiding officer by
January 23, 2008.
ACTION: Notice of hearing.

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1356 Federal Register / Vol. 73, No. 5 / Tuesday, January 8, 2008 / Notices

FOR FURTHER INFORMATION CONTACT: furnished after the recipients have been Any individual or group that wants to
Kathleen Scully-Hayes, Presiding determined eligible (and not during a participate in the hearing as a party
Officer, CMS, Lord Baltimore Drive, retroactive eligibility period) be within must petition the presiding officer
Mail Stop LB–23–20, Baltimore, MD the regulatory exception at 42 CFR within 15 days after publication of this
21244, Telephone: (410) 786–2055. 431.246 and 431.250(b) to the vendor notice, in accordance with the
SUPPLEMENTARY INFORMATION: This payment principle? Those sections requirements contained at 42 CFR
notice announces an administrative provide for corrective payments based 430.76(b)(2). Any interested person or
hearing to reconsider CMS’ decision to on a successful appeal by a recipient organization that wants to participate as
disapprove California’s SPA #06–019B who, pending the appeal decision, amicus curiae must petition the
which was submitted on December 27, sought and paid for covered services. presiding officer before the hearing
2006. Such a circumstance in the context of begins in accordance with the
Under this SPA, the State was seeking SPA 06–019B would exist where a requirements contained at 42 CFR
to provide direct reimbursement recipient appealed the State’s 430.76(c). If the hearing is later
effective October 1, 2006, to Medicaid determination of the amount of the rescheduled, the presiding officer will
recipients where the recipient obtains recipient’s ‘‘share of cost’’ for covered notify all participants.
and pays for Medicaid services after services. But, SPA 06–019B does not The notice to California announcing
receiving a Medicaid card. appear to limit such payment to these an administrative hearing to reconsider
The amendment was disapproved exceptions to the vendor payment rule. the disapproval of its SPA reads as
because it did not comport with the • Is there any binding judicial follows:
requirements of sections 1902(a)(10), decision that would permit the Federal Mr. Stan Rosenstein, Chief Deputy Director,
1902(a)(32), and 1905(a) of the Social Government to participate in the Health Care Program, Health and Human
Security Act (the Act) and Federal payments contemplated in the proposed Services Agency, 1501 Capitol Avenue, MS
regulations at 42 CFR 431.246, 431.250, SPA? The United States was not a party 4506, P.O. Box 997413, Sacramento, CA
to a California State Court case that 99859–7413.
and 447.15.
The following are the issues to be apparently addressed the issues, and is Dear Mr. Rosenstein:
considered at the hearing: not bound by that decision. Moreover, I am responding to your request for
• Would payments under the under regulations at 42 CFR 431.250 reconsideration of the decision to disapprove
that provide for Federal participation in California’s State plan amendment (SPA) 06–
proposed SPA that would be made 109B, which was submitted on December 27,
directly to Medicaid recipients for payments made under court order, the
2006.
services furnished after the recipients services must be provided within the Under this SPA, the State was seeking to
have been determined to be eligible (and scope of the Medicaid program under provide direct reimbursement, effective
not during a retroactive eligibility Federal law. Services that are billed October 1, 2006, to Medicaid recipients
period) be within the scope of the directly to the recipient (and not part of where the recipient obtains and pays for
definition of ‘‘medical assistance’’ a retroactive eligibility period) are Medicaid services after receiving a Medicaid
referenced in section 1902(a)(10) and set outside of the Federal definition of card.
forth in section 1905(a) of the Act? The medical assistance, and thus are not The amendment was disapproved because
definition at section 1905(a) specifically within the scope of the Federal it did not comport with the requirements of
Medicaid program. sections 1902(a)(10), 1902(a)(32), and 1905(a)
limits medical assistance to payments of the Social Security Act (the Act) and
made to providers of covered services • Is there any statutory or regulatory Federal regulations at 42 CFR sections
(the ‘‘vendor payment principle’’), and conflict providing a basis to conclude 431.246, 431.250, and 447.15.
contains an express statutory exception that the express statutory provisions The following are the issues to be
permitting direct payment to recipients establishing the vendor payment considered at the hearing:
only for physician and dentist services; principle could not practically be • Would payments under the proposed
the proposed SPA does not appear to be applied? CMS has recognized such a SPA that would be made directly to Medicaid
limited to payments for these service conflict as the basis for permitting an recipients for services furnished after the
exception to the vendor payment recipients have been determined to be
categories. eligible (and not during a retroactive
• Would payments under the principle during a retroactive period, eligibility period) be within the scope of the
proposed SPA that are made directly to but such a conflict does not appear to definition of ‘‘medical assistance’’ referenced
Medicaid recipients for services be present in this instance. in section 1902(a)(10) and set forth in section
furnished after the recipients have been • Are direct payments to recipients 1905(a) of the Act? The definition at section
determined eligible (and not during a who have been determined eligible 1905(a) specifically limits medical assistance
retroactive eligibility period) be consistent with accuracy, efficiency, to payments made to providers of covered
consistent with the requirement of and effectiveness of the State Medicaid services (the ‘‘vendor payment principle’’),
section 1902(a)(32) of the Act? That program in serving those recipients? and contains an express statutory exception
permitting direct payment to recipients only
section limits payment under the plan Section 1116 of the Act and Federal for physician and dentist services; the
to amounts paid directly to providers (or regulations at 42 CFR Part 430, establish proposed SPA does not appear to be limited
certain assignees of those providers). Department procedures that provide an to payments for these service categories.
This statutory requirement ensures that administrative hearing for • Would payments under the proposed
recipients obtain covered services from reconsideration of a disapproval of a SPA that are made directly to Medicaid
participating providers who bill the State plan or plan amendment. CMS is recipients for services furnished after the
Medicaid program rather than the required to publish a copy of the notice recipients have been determined eligible (and
recipient, and accept the State’s to a State Medicaid agency that informs not during a retroactive eligibility period) be
payment, including a payment of zero the agency of the time and place of the consistent with the requirement of section
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1902(a)(32) of the Act? That section limits


dollars, as payment in full. (See 42 CFR hearing, and the issues to be considered. payment under the plan to amounts paid
447.15.) If we subsequently notify the agency of directly to providers (or certain assignees of
• Would payments under the additional issues that will be considered those providers). This statutory requirement
proposed SPA that are made directly to at the hearing, we will also publish that ensures that recipients obtain covered
Medicaid recipients for services notice. services from participating providers who

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Federal Register / Vol. 73, No. 5 / Tuesday, January 8, 2008 / Notices 1357

bill the Medicaid program rather than the individuals who will represent the State at Drug Administration, College Park, MD
recipient, and accept the State’s payment, the hearing. 20740–3835, 301–436–2022, FAX 301–
including a payment of zero dollars, as Sincerely, 436–2651.
payment in full. (See 42 CFR 447.15.)
• Would payments under the proposed Kerry Weems, SUPPLEMENTARY INFORMATION: CPG Sec.
SPA that are made directly to Medicaid Acting Administrator. 555.700 stated FDA’s policy to routinely
recipients for services furnished after the (Section 1116 of the Social Security Act (42 establish action levels for pesticide
recipients have been determined eligible (and U.S.C. 1316); 42 CFR 430.18) chemical residues to replace tolerances
not during a retroactive eligibility period) be (Catalog of Federal Domestic Assistance that are revoked when the
within the regulatory exception at 42 CFR program No. 13.714, Medicaid Assistance Environmental Protection Agency (EPA)
431.246 and 431.250(b) to the vendor Program.) cancels registration for the pesticide
payment principle? Those sections provide under the Federal Insecticide,
for corrective payments based on a successful Dated: January 2, 2008.
Fungicide, and Rodenticide Act. Such
appeal by a recipient who, pending the Kerry Weems,
appeal decision, sought and paid for covered residues may persist in the environment
Acting Administrator, Centers for Medicare for many years. Section 408(l)(4) of the
services. Such a circumstance in the context & Medicaid Services.
of SPA 06–019B would exist where a Federal Food, Drug, and Cosmetic Act
recipient appealed the State’s determination [FR Doc. E8–109 Filed 1–7–08; 8:45 am] (21 U.S.C. 346a(l)(4)), as amended by
of the amount of the recipient’s ‘‘share of BILLING CODE 4120–01–P the Food Quality Protection Act of 1996,
cost’’ for covered services. But, SPA 06–019B authorizes EPA to establish tolerances
does not appear to limit such payment to for pesticide chemical residues that will
these exceptions to the vendor payment rule. DEPARTMENT OF HEALTH AND unavoidably persist in the environment.
• Is there any binding judicial decision HUMAN SERVICES Therefore, because EPA may establish
that would permit the Federal Government to
participate in the payments contemplated in tolerances for such pesticide chemical
Food and Drug Administration
the proposed SPA? The United States was residues, the policy set forth in CPG
not a party to a California State Court case [Docket No. 2007N–0462] Sec. 555.700 is obsolete. Consequently,
that apparently addressed the issues and is FDA is withdrawing CPG Sec. 555.700,
not bound by that decision. Moreover, under Compliance Policy Guide Sec. 555.700 in its entirety, to eliminate this obsolete
regulations at 42 CFR 431.250 that provide Revocation of Tolerances for policy.
for Federal participation in payments made Cancelled Pesticides (CPG 7120.29); Previously established action levels
under court order, the services must be Withdrawal are listed in FDA’s CPG Sec. 575.100
provided within the scope of the Medicaid Pesticide Chemical Residues in Food
program under Federal law. Services that are AGENCY: Food and Drug Administration,
HHS. and Feed—Enforcement Criteria (CPG
billed directly to the recipient (and not part
7141.01). A notice announcing
of a retroactive eligibility period) are outside ACTION: Notice.
of the Federal definition of medical availability of a draft revision of CPG
assistance, and thus are not within the scope SUMMARY: The Food and Drug Sec. 575.100 is published elsewhere in
of the Federal Medicaid program. Administration (FDA) is announcing the this issue of the Federal Register.
• Is there any statutory or regulatory withdrawal of Compliance Policy Guide Dated: December 31, 2007.
conflict providing a basis to conclude that Sec. 555.700 Revocation of Tolerances Margaret O’K. Glavin,
the express statutory provisions establishing for Cancelled Pesticides (CPG 7120.29)
the vendor payment principle could not Associate Commissioner for Regulatory
(CPG Sec. 555.700). CPG Sec. 555.700 is Affairs.
practically be applied? CMS has recognized
such a conflict as the basis for permitting an no longer necessary because the policy [FR Doc. E8–127 Filed 1–7–08; 8:45 am]
exception to the vendor payment principle stated in the CPG is obsolete. Elsewhere BILLING CODE 4160–01–S
during a retroactive period, but such a in this issue of the Federal Register,
conflict does not appear to be present in this FDA is announcing the availability of a
instance. draft revision of CPG Sec. 575.100 DEPARTMENT OF HEALTH AND
• Are direct payments to recipients who Pesticide Chemical Residues in Food HUMAN SERVICES
have been determined eligible consistent and Feed—Enforcement Criteria (CPG
with accuracy, efficiency, and effectiveness 7141.01) (CPG Sec 575.100). Food and Drug Administration
of the State Medicaid program in serving
those recipients? DATES: The withdrawal is effective [Docket No. 2007D–0463]
I am scheduling a hearing on your request January 8, 2008.
for reconsideration to be held on February ADDRESSES: Submit written requests for Draft, Revised Compliance Policy
15, 2008, at the CMS San Francisco Regional single copies of CPG Sec. 555.700 to the Guide Sec. 575.100 Pesticide Chemical
Office, 90 7th Street, 5th Floor, Room 5A, Division of Compliance Policy (HFC– Residues in Food—Enforcement
San Francisco, California 94103, to 230), Office of Enforcement, Office of Criteria (CPG 7141.01); Availability
reconsider the decision to disapprove SPA Regulatory Affairs, Food and Drug
06–019B. If this date is not acceptable, we AGENCY: Food and Drug Administration,
would be glad to set another date that is
Administration, 5600 Fishers Lane, HHS.
mutually agreeable to the parties. The Rockville, MD 20857. Send two self-
ACTION: Notice
hearing will be governed by the procedures addressed adhesive labels to assist that
prescribed by Federal regulations at 42 CFR office in processing your request or fax SUMMARY: The Food and Drug
Part 430. your request to 240–632–6861. Administration (FDA) is announcing the
I am designating Ms. Kathleen Scully- A copy of the CPG may be seen in the availability of draft, revised Compliance
Hayes as the presiding officer. If these Division of Dockets Management (HFA– Policy Guide (CPG) Sec. 575.100
arrangements present any problems, please 305), Food and Drug Administration, Pesticide Chemical Residues in Food—
contact the presiding officer at (410) 786– 5630 Fishers Lane, rm. 1061, Rockville, Enforcement Criteria (CPG 7141.01) (the
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2055. In order to facilitate any MD 20852, between 9 a.m. and 4 p.m.,


communication which may be necessary
draft CPG). The draft CPG is intended to
between the parties to the hearing, please
Monday through Friday. provide guidance to FDA staff on FDA’s
notify the presiding officer to indicate FOR FURTHER INFORMATION CONTACT: internal enforcement processes
acceptability of the hearing date that has Michael E. Kashtock, Center for Food concerning pesticide chemical residues
been scheduled and provide names of the Safety and Applied Nutrition, Food and in food.

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