A Victory for “Off-Label” Prescription Drug Coverage

https://medicareadvocacy.org/a-victory-for-off-label-prescription-drug-coverage/

On February 11, 2022, the U.S. Court of Appeals for the 11^th Circuit reversed a lower-court decision and found that Medicare must provide coverage for a beneficiary’s off-label use of a medication in Dobson v. Secretary of Health & Human Services, No. 20-11996, 2022 WL 424813 (11^th Cir. Feb. 11, 2022). Florida resident Donald Dobson contacted the Center for Medicare Advocacy because his Medicare Part D plan denied coverage for dronabinol. He could not afford the medication without coverage, but he needed it critically. Since he suffered a spinal cord injury and underwent related surgeries, Mr. Dobson has experienced intractable, severe nausea and vomiting that interfere with his ability to function and other aspects of his health. After standard anti-nausea medications failed to alleviate his symptoms, Mr. Dobson’s physicians prescribed dronabinol (brand name Marinol), which worked immediately.

However, when Mr. Dobson became eligible for Medicare based on his disability, his Part D plan denied coverage of dronabinol. The denial was based on the prescription being “off-label,” meaning it was for a non-FDA approved use. Off-label prescribing is a routine, legal practice, frequently used when medications are needed to treat less-common conditions. But Medicare Part D requires more than a doctor’s prescription for off-label coverage. The program allows for coverage only if there is “support” for a particular off-label use in one of the “drug compendia” specified by Medicare law. The drug compendia are essentially reference books that summarize information on prescription medications, including chemical ingredients, potential side effects, clinical studies, and different uses for the drugs. (The compendia are also commercial publications, available only to paid subscribers, so it can be very difficult for Medicare beneficiaries to access the information they need to argue for off-label coverage of needed medications.)

Medicare agreed that dronabinol was medically necessary for Mr. Dobson. There is also a compendium entry indicating dronabinol’s off-label use for intractable nausea and vomiting that is disease-related – his very condition. Yet Medicare denied coverage on the grounds that his use was not “supported by” that compendium entry because Mr. Dobson did not share exactly the same underlying diagnosis as the patient described in the entry’s cited case study.

Conducting a thorough analysis of the Medicare Part D statute, the 11^th Circuit decided that Congress’s intent was clear. For an off-label use to be “supported by” a compendium citation, the citation “must tend to show or help prove the efficacy and safety of the prescribed medication.” Furthermore, “[n]othing about the common meaning of ‘support’ means that a compendium citation must hyperspecifically identify a prescribed off-label use to tend to show or help prove its efficacy and safety.” Using this commonsense meaning of the word “support,” the court concluded that the listing in question requires Medicare to cover Mr. Dobson’s off-label use of dronabinol.

The Center for Medicare Advocacy plans to issue additional material with further details and practice tips for advocates in light of the decision, assuming it stands. The Center is grateful to co-counsel Florida Health Justice Project and Akin Gump Strauss Hauer & Feld.

Filed under: General Problems