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Bruce v. Azar

United States District Court, N.D. California

December 16, 2019

STEVEN BRUCE, Plaintiff,
v.
ALEX M. AZAR, Defendant.

          ORDER ON CROSS MOTIONS FOR SUMMARY JUDGMENT RE: DKT. NOS. 90, 94

          HAYWOOD S. GILLIAM, JR. UNITED STATES DISTRICT JUDGE

         Pending before the Court are the parties' cross motions for summary judgment. Dkt. Nos. 90 (“Pl. Mot”), 94 (“Def. Mot”). The Court held a hearing on the motions on December 5, 2019. After carefully considering the papers and the parties' arguments, the Court DENIES Plaintiff's motion for summary judgment and GRANTS Defendant's motion for summary judgment.

         I. BACKGROUND

         Plaintiff Stephen Bruce filed this action on August 16, 2018, seeking judicial review of the final decision by the Medicare Appeals Council (“MAC”) denying Plaintiff coverage for the drug Serostim. Dkt. No. 1. The Court provides the relevant statutory framework and facts below.

         A. Part D of the Medicare Act

         The Medicare Act, established under Title XVIII of the Social Security Act, 42 U.S.C. § 1395 et seq., provides coverage for certain medical services to eligible aged and disabled individuals. Maximum Comfort Inc. v. Sec'y of Health & Human Servs., 512 F.3d 1081, 1083 (9th Cir. 2007). At issue here is Part D of the program, which is a voluntary prescription drug benefit program established by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (“Medicare Modernization Act”). Pub. L. No. 108-173, 117 Stat. 2066 (2012). Part D provides coverage for certain types of drugs: (1) prescription drugs; (2) biological products; (3) insulin and insulin supplies used to inject insulin; and (4) vaccines. See 42 U.S.C. § 1395w-102(e).

         Under the statute, the term “covered part D drug” includes “any use of a covered part D drug for a medically accepted indication.” Id. § 1395w-102(e)(1). The definition of “medically accepted indication” depends on whether the medication is used in an “anticancer chemotherapeutic regimen.” Id. § 1395w-102(e)(4). If not, as is the case here, “medically accepted indication” is defined by cross-reference to 42 U.S.C. § 1396r-8(k)(6), which states:

The term “medically accepted indication” means any use for a covered outpatient drug which is approved under the Federal Food, Drug, and Cosmetic Act or the use of which is supported by one or more citations included or approved for inclusion in any of the compendia described in subsection (g)(1)(B)(i).

Id. § 1396r-8(k)(6). The “compendia described in subsection (g)(1)(B)(i)” consist of: (1) the American Hospital Formulary Service Drug Information (“AHFS-DI”); (2) United States Pharmacopeia-Drug Information (“USPDI”) (or its successor publication); and (3) the DRUGDEX Information System. Id. § 1396r-8(g)(1)(B)(i).

         B. Plaintiff's Requests for Coverage of Serostim

         Plaintiff is a Medicare beneficiary enrolled in Part D, administered by Envision in 2016 and Blue Shield in 2017. AR 49, 720.[1] In July 2016, he was diagnosed with lipodystrophy or wasting syndrome (used interchangeably in Plaintiff's case), a rare disorder which causes Plaintiff to suffer from severe and progressive weight loss. AR 82. To halt this weight loss, his primary physician, Dr. Louis J. Cubba, M.D., prescribed Serostim, which Dr. Cubba said was the only medication “that was able to successfully halt his progressive, life threatening, weight loss.” Id.

         Plaintiff submitted a request for coverage of Serostim to his insurers, Envision in 2016 and Blue Shield in 2017. See AR 184-85, 192-94, 630-31. Both insurers denied coverage because Plaintiff's use of Serostim for lipodystrophy was not prescribed for a “medically accepted indication.” See id.

         i. Plaintiff's Appeal in 2016

         In September 2016, Plaintiff filed a reconsideration request with the independent review entity (“IRE”). AR 1217-18. The physician reviewer found that the “Part D Plan was correct in denying the request for Serostim, ” because it was prescribed for “off-label (non-FDA) approved uses, ” and the Medicare-approved compendia ...


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