January 12, 2015

DEPARTMENT OF HEALTH & HUMAN SERVICES

Centers for Medicare & Medicaid Services
Center for Consumer Information & Insurance Oversight
200 Independence Avenue SW
Washington, DC 20201

Re: DRAFT 2016 Letter to Issuers in the Federally-facilitated Marketplaces

Dear Colleagues,
Thank you for the opportunity to comment on the DRAFT 2016 Letter to Issuers in the
Federally-facilitated Marketplaces. The letter states that: Additionally, CMS is considering
conducting a review of each QHP to identify outliers based upon estimated out-of-pocket costs
associated with standard treatment protocols for specific medical conditions using nationallyrecognized clinical guidelines. The conditions under consideration include: bipolar disorder,
diabetes, HIV, rheumatoid arthritis, and schizophrenia.
Also in reviewing a plans cost-sharing structure, CMS will analyze information contained in the
Plans and Benefits Template, including, but not limited to the explanations and exclusions
sections, with the objective of identifying discriminatory features or wording. Discriminatory
cost sharing language would typically involve reduction in the generosity of a benefit in some
manner for subsets of individuals for reasons not clearly based on common medical management
practices.
The letter also states, if an issuer places most or all drugs that treat a specific condition on the
highest cost tiers, that plan design effectively discriminates against, or discourages enrollment
by, individuals who have those chronic conditions.
We strongly urge CMS to add hepatitis C to the list of conditions for which the agency will
investigate health insurance companies for discrimination against people with costly conditions.
According to 45 CFR 156.125(a), an issuer does not provide EHB if its benefit design (or the
implementation thereof) discriminates based on, among other factors, an individual's present or
predicted disability, degree of medical dependency, or other health conditions. There is no other
condition for which insurance companies have more aggressively denied safe, effective,
medically indicated treatment to so many Americans than hepatitis C. Revolutionary new
therapies for hepatitis C, while highly effective, have come with a high price tag for the millions
of Americans who need to be treated and cured. Insurance plans have consequently placed drugs
that treat hepatitis C on the highest cost tiers, and are implementing discriminatory rules about
who can access the medication based solely on cost and not on medical need or standard of care.
These restrictions, including extensive preauthorization requirements based on fibrosis stage,
substance use history, and provider experience, among others, have no basis in scientific
evidence, medical practice, or law, and indeed directly contradict authoritative medical
guidelines.1These policies represent a radical departure from standard insurance practices for

covering standard treatment protocols for specific medical conditions using nationallyrecognized clinical guidelines. A recent article highlighting the disparities quotes Terri Cathers,
pharmacy director for Pennsylvanias Office of Medical Assistance Programs as saying "This is
an unprecedented approach we've had to take with these drugs. We've not done this before for
other treatments as long as I've been in the business."2
The undersigned organizations request the addition of hepatitis C to the list of conditions under
review. In addition, we ask HHS to articulate in the regulation each of the following as examples
of prohibited discriminatory practices:
Limiting access to hepatitis C treatment only to individuals with advanced liver disease
(Metavir scores of F3 or F4 or other corresponding measure). This medically
inappropriate practice makes it impossible for physicians to use the new therapies to
prevent cirrhosis, as they were intended. Instead, in many cases, patients have to first
develop cirrhosis in order to qualify for treatment. Hepatitis C is the only condition in
which patients are forced to develop a new disease (cirrhosis) in order to qualify for
treatment of an existing condition (hepatitis C). This practice also interferes with the
integrity of the physician-patient relationship and puts medical decision-making in the
hands of insurers, rather than clinicians.
Policies that deny or limit access to treatment to individuals living with past or current
substance use disorders. In addition to being medically unfounded and discriminating
against people with addictive or substance use disorders, this practice significantly
undermines the ability to interrupt ongoing transmission of the hepatitis C virus among
populations most at risk, thus harming both individual and public health. Hepatitis C is
the only condition for which insurance companies can thwart efforts to prevent
transmission by refusing to cover medically indicated, curative treatment.
Policies that limit the types of providers who may prescribe hepatitis C medications
and/or treat hepatitis C in patients that, in effect, limit access to treatment. This medically
unjustified practice makes it impossible for qualified physicians to prescribe curative
treatment for a life-threatening communicable disease to patients who need it. There are
not enough specialists to treat all the patients with hepatitis C. Prior to the release of the
new direct acting antivirals, which are highly effective and have very few side effects,
standard hepatitis C treatment was pegylated interferon and ribavirin. This regimen was
extremely difficult for patients to tolerate and fraught with terrible side effects and
complex management issues. Yet, insurers rarely, if ever, restricted what type of provider
could treat hepatitis C in this era. Now that the drugs are simpler to manage and relatively
easy to tolerate, it does not make sense to increase restrictions on which providers can
prescribe, especially in light of the shortage of specialists. Again, this practice will have
the effect of damaging both individual and public health, and prolonging the hepatitis C
epidemic, with its high health and financial costs.
Together, these practices limit access to hepatitis C treatment in ways that are medically
unsupportable and appear to violate federal prohibitions on discrimination. Hepatitis C is the
most common chronic blood borne virus in America. Treatment can now quickly, easily, and
safely cure this life-threatening infection in almost all patients. We can eliminate hepatitis C in
our lifetime, but only if all people have access to treatment. We urge HHS to take action to
remove these unnecessary barriers to access to a cure.

Thank you for your consideration.

Lorren Sandt
Caring Ambassadors Program
Organization Support
A and B Bus Service Franklin Park, IL 60131
AASLD, Washington, DC 20024
AIDS Action Baltimore, Baltimore, MD 21201
AIDS United Washington DC 20002
Allies Linked for the Prevention of HIV and AIDS Boise, ID 83702
Association of Asian Pacific Community Health Organizations, Oakland, CA 94612
AZ Hepatitis C Coalition Phoenix, AZ 85001
Baltimore City Health Dept/JHU SOM Baltimore MD 21217
Bankstreet School for Children New York, NY 10025
Berkeley Free Clinic Berkeley, CA 94702
Brain Body Harmony Prompon Lakes, NJ 07442
Bronx Lebanon Hospital FM Bronx, NY 10456
C.O.R.E. Medical Clinic, Inc. Sacramento, CA 95816
Caring Ambassadors Program, Inc. Chicago IL 60626
Chase North Richland Hills, TX 76182
Chicago Recovery Alliance Chicago, IL 60612
CHOW Project Honolulu, HI 96813
Cincinnati Exchange Project Cincinnati, OH 45267
Drug Policy Alliance Trenton, NJ 08608
Duke University Durham, NC 27710
Environmental Technologist Santa Rosa, CA 95403
FPI Baltimore MD 21201
Frederick Co. Hepatitis Clinic,Inc. Frederick , MD 21702
Gilead Sciences, Inc Leesburg, VA 20176
Global Liver Institute Washington, DC 20016
Green & Associates Ventura, CA 93001
Grubb's Pharmacy Washington, DC 20003
H.E.A.L.S of the South Tallahassee, FL 32318
H2CTP,org Leawood, KS 66224
Harm Reduction Coalition New York, NY 10001
Haymarket Center Chicago, IL 60607
HCV Advocate West Sacramento, CA 95605
HCV Coalition For The Cure San Antonio, TX 78257
HealthHIV Washington, DC 20009
Hemophilia Federation of America Washington, DC 20002
Hep B United Doylestown, PA 18902
Hep C Alliance Columbia, MO 65203
Hep C Connection, Denver, CO 80222
Hep C Meditations Project San Francisco, CA 94107

Hep Free Hawaii Honolulu, HI 96813

Hepatitis B Foundation Doylestown, PA 18902
Hepatitis C Allies of Philadelphia (HepCAP) Philadelphia, PA 19146
Hepatitis C Association Scotch Plains, NJ 07076
The Hepatitis C Mentor & Support Group, Inc. New York, NY 10016
Hepatitis Education Project Seattle, WA 98104
Hepatitis Foundation International Silver Spring, MD 20769
HepTREC @ University of the Sciences Philadelphia, PA 19104
HONOReform Fremont, NE 68025
Illinois Consortium on Drug Policy Roosevelt University Chicago, IL 60605
Injection Drug Users Health Alliance New York, NY 10024
ISRAEL DAVID
Chula Vista, CA 91910
Johns Hopkins School of Medicine Baltimore, MD 21205
Johnson & Johnson Baltimore, MD 21224
Kartini Clinic Portland, OR 97227
Lee School District Fort Myers, FL 33919
Liver Education Advocacy Prevention Services
Cleveland, OH 44120
Maryland Hepatitis Coalition Baltimore,MD 21201
McDonald & McDonald, Inc. Newburgh, NY12550
MedStar Health Research Institute Washington, DC 20010
Mount Sinai Beth Israel New York, NY 10038
Mount Sinai Hospital Chicago, IL 60610
National Alliance of State and Territorial AIDS Direcotrs (NASTAD), Washington, DC 20001
National Development and Research Institutes / John Jay College New York, NY 10010
NDRI-USA, Inc.
New York, NY 10010
NYC -DOHMH
Queens, NY 11101
One in Four Chronic Health Clackamas, OR 97015
Orbitz Worldwide
Chicago, IL 60661
Point Defiance AIDS Projects Tacoma, WA 98417
PPSI Novato ,CA 94949
PPSI, MCPHA Tiburon,CA 94920
Progressive Medical Education Mancos, CO 81328
Project Inform San Francisco, CA 94103
RI Defeats Hep C
Providence, RI 02906
rocktenn
Philadelphia, PA 19111
Rosenbury Farms Butler, IN 46721
San Francisco Hepatitis C Task Force San Francisco, CA 94103
San Luis Obispo Co. AIDS Support San Luis Obispo, CA 93401
Santa Rosa Community Health Centers
Santa Rosa, CA 95403
Silver Spring Hepatitis Support Group
Silver Spring, MD 20904
Syracuse University Syracuse, NY 13244
The Hepatitis C Mentor and Support Group, Inc. New York, NY 10016
The Leather FONDATION San Diego, CA
92167
Total Health Care
Baltimore, MD 21217
Treatment Action Group New York, NY 10016
United Association Vancouver,WA 98663

Unity Health Care Washington, DC 20009

University Hospital Liver Transplant Support Group Newark, NJ 07103
University of Chicago Chicago, IL 60637
University of Maryland Medical Center Baltimore, MD 21201
University of Maryland School of Medicine Baltimore, MD 21201
University of Maryland School of Pharmacy Baltimore, MD 21201
Weill Cornell Medical College New York, NY 10010
Yorkville Yoga New York, NY 10021
Individual supporters
Andrew Reynolds
Oakland
CA
94619
Anna Miranda
Middletown NJ
7748
betty houghton
Gulfport
MS
39507
Brady Taylor
Naples FL
34104
Brooke Clark RN
EugeneOR
97401
Carl E and Jean F Mangum
Morris Plains NJ
7950
Christina hart
Chicago
IL
60613
Christine Paskavich Centralia
IL
62801
Dan Hobson
Madison
WI
53073
Deborah Wanyo
walnutport
PA
18088
Dr. Steven A. PeligianNorth Kingstown
RI
2852
Duane Quintana
Chicago
IL
60660
Eileen Wagner
Deer Park
TX
77536
Franchesca Powell Lexington
KY
40505
J. Gervasio
Durham
NC
27701
Janet Marsh
Rego Park
NY
11374
Jean Byer
Gallatin
TN
37066
Jocelyn
Greensboro NC
27410
Josiah D.Rich, MD, MPH Professor of Medicine, Brown University Providence RI 02906
Judy Rodenstein
Silver Spring MD 20901
Julie Acklin BOARD OF DIRECTOR HAC
Peoria AZ
85345
Karen Sandt
New York
NY
10028
Karl Halpin
Belleville
NJ
7109
Kathy Willingham
Macon GA
31211
Lawrence Holley
Parkville
MD 21234
Leonard A. Petruska Robbinsville NJ
8691
Lisa Velazquez
Fort Pierce
FL
34981
Lucinda Porter Author, Hepatitis C One Step at a Time
Grass Valley CA
95945
Lynda Levatino TobinGreensboro NC
27410
Mindy ONeal
Louisville
KY
40229
Naasir Qavi
Chicago
IL
60641
Noreen Jacome
Schaumburg IL
60173
Paul Wise
Stamford
CT
6902
Pete Dudley
San Leon
TX
77539
Robert Blomeier
Lititz
PA
17543
Robert Gish, MD
San Diego
CA
92037

Robert J. Crumrine
Sandra Jones
Stacy kaufman
Ted Formeza
Wesley Clark
William A. Wilson

Grants Pass OR
Salt Lake City UT
New York
NY
Perth Amboy NJ
Brooklyn
NY
Nashville
TN

97526
84104
10012
8861
11217
37211

1. American Association for the Study of Liver Diseases, Infectious Diseases Society of
America. Recommendations for Testing, Managing, and Treating Hepatitis C. Updated
2014. Available at: http://www.hcvguidelines.org/.
2. Weiss L. New drugs offer hope, barriers for hepatitis C patients. Philadelphia Inquirer,
January 4, 2015. Available at:
http://www.philly.com/philly/health/20150104_New_drugs_offer_hope__barriers_for_he
patitis_C_patients.html