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Strese v. Rhode Island Executive Office of Health & Human Services

Superior Court of Rhode Island

February 15, 2018

MARION STRESE
v.
RHODE ISLAND EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

         Providence County Superior Court

          For Plaintiff: Gretchen M. Bath, Esq.

          For Defendant: Gregory Hazian, Esq.

          DECISION

          STERN, J.

         Marion 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 Decision.

         I

         Facts and Travel

         Appellant is a sixty-three-year-old female who was diagnosed with hepatitis C in her late thirties or early forties. (SAR[1] 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.

         During that time, [2] 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 ineffective. Id.

         These 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.

         Harvoni, 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.

          As a 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 damage:

"Documentation may be by any of the following:
"i. AST to Platelet Ratio Index (APRI) greater than or equal to
1.0 "ii. Current liver biopsy is not required, however previous liver biopsy indicating METAVIR score of 3 or 4 may be used
"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.

         It is undisputed that Appellant's liver disease is not this advanced. Id. at 139.

         As a result of the Policy, on May 25, 2016, the United Healthcare Community Plan (UHCCP)[3] 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.

         On 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.

          At the 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, [4] in 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.

         UHCCP 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[5] or the Superior Court pursuant to § 42-35-7, [6] if she sought to invalidate or override the Policy. Id. at 156-57.

         UHCCP's 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.

         Appellant 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, ...


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