Bruce v. Azar
- Haywood Gilliam
- 4:18-cv-05022
- U.S. District Court · Northern District of California
- 8
In Bruce v. Azar, Judge Gilliam affirmed the Medicare coverage denial, denied Bruce’s motion, and granted the government’s summary-judgment motion.
Steven Bruce did not obtain Medicare Part D coverage for Serostim for his non-HIV-related lipodystrophy. The defendant prevailed, and the Medicare Appeals Council’s denial was affirmed.
What happened
In Bruce v. Azar, Steven Bruce sought coverage under Medicare Part D for Serostim, a drug prescribed for his non-HIV-related lipodystrophy. His insurers denied coverage because that use was not approved by the Food and Drug Administration or listed in approved medical references.
The court ruled that Medicare Part D covers the drug only when used for a medically accepted indication. Because the record did not show that Serostim was approved or listed for Bruce’s condition, the court found that the Medicare Appeals Council had substantial evidence and had not made a legal error. The court also rejected Bruce’s argument that a special exception required coverage.
Judge Haywood S. Gilliam, Jr. denied Bruce’s motion for summary judgment, granted the defendant’s motion for summary judgment, denied Bruce’s motions to submit additional documents, affirmed the Appeals Council’s decision, and directed entry of judgment for the defendant.
The detailed version
- Bruce v. Azar · No. 4:18-cv-05022
- Haywood Gilliam
- Dec. 16, 2019
Background
Steven Bruce, a Medicare beneficiary enrolled in Medicare Part D, sought coverage for Serostim. His physician prescribed the drug to treat lipodystrophy, also called wasting syndrome, which caused severe and progressive weight loss. Bruce’s Part D plans denied coverage in 2016 and 2017 because the prescribed use was not a “medically accepted indication.”
The Medicare Appeals Council reviewed the administrative law judges’ decisions and concluded that Part D did not cover Serostim for Bruce’s condition. Bruce then filed this action seeking judicial review of that decision. The court previously dismissed his due-process and Rehabilitation Act claims, leaving only his challenge to the coverage decision.
Court’s Analysis
The court explained that Medicare Part D covers a drug only when it is used for a “medically accepted indication.” For the use at issue, that meant either an approval under the Federal Food, Drug, and Cosmetic Act or support in one of the Medicare-approved drug compendia, which are medical reference publications.
The Food and Drug Administration’s label approved Serostim for HIV patients with wasting or cachexia. Bruce did not dispute that he did not have HIV-related wasting syndrome. The record also listed other uses in the relevant compendia, but did not show that the compendia supported Serostim for non-HIV-related lipodystrophy. The court therefore held that Bruce’s prescribed use did not meet the statutory definition of a covered Part D drug.
Bruce argued that “medically accepted indication” was only illustrative, rather than a binding definition. The court rejected that argument and held that the statute clearly required the limitation. The court also rejected Bruce’s argument that excluding non-HIV-related lipodystrophy was unreasonable or violated substantive due process, explaining that deciding whether coverage should be expanded as a policy matter was outside the court’s role.
Bruce separately argued that the Appeals Council failed to apply a regulatory formulary exception. The court found that the Appeals Council had considered the exception and reasonably concluded that it could not be used to cover a drug that did not meet the definition of a Part D drug. Because Bruce had not shown that his use of Serostim qualified as a Part D drug, the exception did not apply.
Disposition
The court found that the Appeals Council’s decision was supported by substantial evidence and was not based on legal error. Judge Haywood S. Gilliam, Jr. denied Bruce’s motion for summary judgment, granted the defendant’s motion for summary judgment, and denied Bruce’s administrative motions to file additional documents. The court affirmed the Appeals Council’s decision, directed the Clerk to enter judgment for the defendant, and closed the case.
Read the full 8-page opinion on CourtListener, the free public archive maintained by the Free Law Project.