Medicare has agreed to cover an essential medication for a retired public school teacher in New Jersey who needs the drug to control debilitating symptoms of a digestive system disorder.
Cheryl Hough experiences extreme nausea, vomiting, and abdominal pain from a condition related to her Type I diabetes. She suffered for years and tried several medications that were ineffective. Only when her doctor added dronabinol to her medication regimen did she find relief. Ms. Hough’s Medicare Part D plan agreed that dronabinol is medically necessary for her. But it denied coverage because her use of dronabinol is “off-label” (non-FDA-approved). Ms. Hough and her husband struggled to pay the full price of the drug out of pocket. Ms. Hough could not even try to enroll in a different Part D plan, as her Medicare coverage is determined by a union for New Jersey educators. Under the settlement agreement, Medicare will cover dronabinol, reimburse her for past costs, and agreed to deem Ms. Hough’s use of the drug a “medically accepted indication” for her.
“The settlement has taken a load off my mind and will contribute to my well-being,” said Ms. Hough.
The Center for Medicare Advocacy filed the lawsuit on behalf of Ms. Hough in November 2022, alleging that Medicare’s denial of coverage was based on an overly restrictive interpretation of what counts as a “medically accepted indication” under the law. The case, Hough v. Becerra, No. 3:22-cv-06687 (D.N.J.), was very similar to Dobson v. Secretary of Health and Human Services, 2022 WL 424813 (11th Cir. Feb. 11, 2022), in which the Center won coverage of the same drug for a Florida beneficiary.
Off-label prescribing is common, estimated to account for up to 20% of prescriptions in the United States. But Medicare’s rules for covering off-label medications are restrictive and out of line with standard practice. With limited exceptions, coverage depends on finding “support” for an off-label use in one of two specific “drug compendia” that provide overviews of clinical studies and medical literature. If a beneficiary’s off-label use is not supported by a citation in one of the drug compendia, Part D plans generally deny coverage regardless of medical necessity. What’s more, even in cases where there is support in a compendium for an off-label use, Medicare may still deny coverage, claiming that unless the beneficiary’s exact diagnosis is mentioned, Medicare cannot pay for the medication. That is what happened in both Dobson, and Ms. Hough’s case.
The favorable decision in Dobson held that “support” for an off-label use means that the compendium must show or help prove the efficacy and safety of the beneficiary’s prescribed off-label use. The compendium does not have to “hyperspecifically identify” the use. Ms. Hough requested that the same reasoning be applied in her case. In addition to being represented by the Center for Medicare Advocacy, Ms. Hough was also represented by the law firm of Murphy Orlando LLC. The Center thanks Murphy Orlando for its generous support and assistance.
June 8, 2023 – A. Bers