On February 11, 2022, the appellate court for the 11th circuit reversed a decision by a lower court. The appellate court in Dobson v. Secretary of Health and Human Services held that Medicare must provide coverage for a beneficiary’s off-label use of a medication.
How the Case Arose
The case concerns a Florida man who communicated with the Center for Medicare Advocacy because the man’s Part D Medicare coverage declined dronabinol coverage. Dronabinol is a man-made type of cannabis that is known under the trade names of Marinol, Reduvo, and Syndros. The medication is used to stimulate appetite as well as to treat nausea and sleep apnea. The medication is approved by the FDA for the treatment of HIV/AIDS-related anorexia and nausea and vomiting caused by chemotherapy.
Without Part D coverage, the man could not afford the medication even though he critically needed it. Following an injury to his spinal cord and associated surgeries, the man experienced severe nausea and vomiting.
Although the man incurred a spinal cord injury and proceeded under associated surgeries, the man has incurred severe nausea and vomiting that impact his ability to function. After other anti-nausea medications did not decrease the severity of the man’s symptoms, his doctor prescribed dronabinol (in the form of Marinol) which promptly worked.
The Trouble with Part D
When the man’s disability qualified him for Medicare, part D of his Medicare plan denied coverage of the medication. Part D’s reason it did not cover the medication that the prescription was considered “off-label”, which means that the medication was for a non-FDA approved use. Off-label prescriptions are a routine practice when medications are required to treat less-common medical conditions. Part D permits coverage only if support exists for certain off-label use in one of the drug compendia as specified by Medicare regulations. The compendia are reference books that encapsulate details about prescription medications including chemical ingredients as well as side effects and clinical studies. Because the compendia are also available as commercial publications that are paid subscription only, Medicare recipients sometimes often have difficulty accessing this information.
Medicare agreed with the man that dronabinol was medically necessary. A compendia entry also shows that the medication’s off-label use for nausea and vomiting that is associated with a disease. Medicare, however, declined coverages on the basis that the man’s use was not supported by the compendia entry because the man did not share the same diagnosis as the patient described in the cited case study.
The Court’s Decision
Performing a detailed review of Medicare Part D, the 11th Circuit concluded that Congressional intent was clear. The court found that for off-label uses to be “supported” by compendia citations, the citations must either show or help establish the efficacy and safety of the medication. Additionally, the court noted that nothing can be done about the ordinary meaning of support which means that a compendia citation must identify a prescribed off-label use to show or help establish its safety and efficacy. Relying on the ordinary meaning of support, the court found that the listing required Medicare to cover the man’s use of dronabinol.