County Superior Court
Plaintiff: Gretchen M. Bath, Esq.
Defendant: Gregory Hazian, Esq.
Strese (Appellant or Ms. Strese) appeals a decision of the
Rhode Island Executive Office of Health and Human Services
(OHHS) finding that she is ineligible for coverage for a
medication-Harvoni-to treat her hepatitis C virus. Ms. Strese
argues that the decision was arbitrary and in violation of
federal law requiring states that accept prescription drug
reimbursement as part of Medicaid provide access to all
medically necessary medications. Jurisdiction is pursuant to
G.L. 1956 § 42-35-15. For the reasons set forth in this
Decision, this Court sustains Ms. Strese's appeal,
vacates the hearing officer's decision, and remands this
case to OHHS for further proceedings consistent with this
is a sixty-three-year-old female who was diagnosed with
hepatitis C in her late thirties or early forties.
at 151-52.) Appellant receives Supplemental Security Income,
and is therefore a "categorically needy" Medicaid
recipient. Id. at 160; 42 U.S.C. §
1396a(a)(10)(A)(i). For about the past twenty years, she has
been treated primarily by her gastroenterologist, Dr. Raymond
Mis (Dr. Mis). Id. at 152-53.
that time,  Appellant underwent three separate courses
of treatment for hepatitis C. Id. at 154-55. Dr. Mis
first prescribed Appellant a course of interferon, which
involved three injections and four pills daily for a period
of eight months. Id. at 154. Regrettably, the
treatment failed, and the viral infection persisted.
Id. Appellant then saw another doctor who prescribed
Intron, but that too failed. Id. Appellant returned
to Dr. Mis thereafter, and he prescribed Pegasys, another
injectable medication, to treat Appellant's hepatitis C.
Id. After nearly completing the treatment regimen,
Appellant experienced an adverse reaction to the drug, which
required Dr. Mis to discontinue its use. Id. at
154-55. Like the previous two attempts, this too was
three treatment attempts took place over a period of years as
treatment options for hepatitis C developed. Id. at
153-54. In 2015, Appellant returned to Dr. Mis. Id.
at 155. It was then that Dr. Mis prescribed Harvoni for
Appellant's hepatitis C. Id.
which received FDA approval in 2014, is a direct-action
antiviral that has proved effective as a treatment for
hepatitis C. Diana Gritsenko & Gregory Hughes,
Ledipasvir/Sofosbuvir (Harvoni): Improving Options for
Hepatitis C Virus Infection, 40 Pharm. and Therapeutics
256, 256 (2015) (hereinafter Gritsenko &
Hughes). Unlike the previous treatment options
prescribed to Appellant, Harvoni has a substantially higher
success rate- approaching 99% effectiveness. Id. at
256-58. With higher efficacy comes a higher price tag,
however-the course of treatment Appellant seeks would cost in
excess of $100, 000. Id. at 259.
result of the drug's price, OHHS established a policy
limiting coverage for Harvoni to patients with advanced liver
damage (the Policy). (SAR at 15-19.) To qualify for Harvoni,
Medicaid recipients must have severe liver scarring;
specifically, stage 3 or 4 hepatic fibrosis or cirrhosis.
Id. at 16. The Policy provides for several
diagnostic criteria that can demonstrate this level of liver
"Documentation may be by any of the following:
"i. AST to Platelet Ratio Index (APRI) greater than or
1.0 "ii. Current liver biopsy is not required, however
previous liver biopsy indicating METAVIR score of 3 or 4 may
"iii. Fibroscan score greater than or equal to 9.5kPa
"iv. Fibrotest score greater than or equal to 0.58
"v. Imaging study consistent with cirrhosis"
Id. at 16.
undisputed that Appellant's liver disease is not this
advanced. Id. at 139.
result of the Policy, on May 25, 2016, the United Healthcare
Community Plan (UHCCP) denied Appellant's preauthorization
request for Harvoni coverage. Id. at 54. Dr. Mis
personally appealed UHCCP's initial decision to deny
Appellant coverage for Harvoni. Id. at 57. Dr. Mis
argued that Appellant and the healthcare system as a whole
would be better served by allowing treatment before
Appellant's hepatitis C caused more serious liver
scarring. Id. Despite his request, on August 5,
2016, UHCCP again denied preauthorization citing the Policy
as determinative of the issue. Id. at 74.
August 30, 2016, through counsel, Appellant filed a Level 2
appeal of UHCCP's decision to deny coverage for Harvoni.
Id. at 76. On September 14, 2016, this appeal too
was denied based upon application of the Policy. Id.
at 85. On September 24, 2016, Appellant filed a request for a
hearing with OHHS. Id. at 1.
December 15, 2016 hearing before the OHHS hearing officer
(the Hearing Officer), Appellant, through counsel, argued
that the Policy was in violation of federal Medicaid law
because it failed to consider her medical need for Harvoni.
Id. at 7, 115, 141. Appellant cited to a United
States District Court case from the district of Washington,
which the court certified a class and granted a preliminary
injunction requiring Medicaid coverage for Harvoni for
hepatitis C patients where the state had a similar policy to
the one at issue here. Id. at 160.
maintained, however, that the Policy governed the dispute,
and that the Hearing Officer lacked jurisdiction to
invalidate the Policy as violative of federal law.
Id. at 156. UHCCP suggested at the hearing that
Appellant seek a declaration, either from OHHS pursuant to
§ 42-35-8 or the Superior Court pursuant to §
42-35-7,  if she sought to invalidate or override
the Policy. Id. at 156-57.
Chief Medical Officer for the Rhode Island Medicaid plan, Dr.
Renee Rulin, testified at the hearing that she was familiar
with the Policy, and that the documentation provided by
Appellant in her preauthorization request did not establish
stage 3 or 4 hepatic fibrosis or cirrhosis as required by the
Policy. Id. at 142-45. Dr. Rulin did not indicate
consideration of any factors other than the stage of
Appellant's fibrosis in determining her ineligibility for
Harvoni coverage. Id.
also testified at the hearing. Id. at 151. She
chronicled her history with hepatitis C and her past failed
treatment regimens. Id. at 151-55. She also detailed
the symptoms she experiences regularly, including lack of
appetite and fatigue, ...