Center for Medicare Advocacy Sues, Again, for Coverage of “Off-label” Prescription Drug

On November 18, 2022, the Center for Medicare Advocacy and Murphy Orlando LLC filed suit on behalf of a retired public-school teacher in New Jersey who seeks coverage of her “off-label” (non-FDA-approved) use of a critically needed medication. Medicare denied coverage of the only medication that Cheryl Hough and her doctor have found to control her debilitating symptoms related to gastroparesis, a disease of the digestive system. However, the denial was based on an overly restrictive interpretation of what counts as a “medically accepted indication” under the law. After exhausting Medicare’s appeal system, Ms. Hough is now requesting review in federal court to receive coverage of the medically necessary treatment.

The case is very similar to Dobson v. Secretary of Health and Human Services, 2022 WL 424813 (11^th Cir. Feb. 11, 2022), in which the Center recently won coverage of the same drug for a Florida beneficiary. The Dobson court held that “support” for an off-label use means that an approved medical compendium that discusses the drug in question must tend to show or help prove the efficacy and safety of the beneficiary’s prescribed use. Support does not mean that a compendium must “hyperspecifically identify” the prescribed off-label use of the beneficiary, as Medicare is requiring. The same reasoning should apply in this case.

The Center is grateful for the generous pro bono assistance of Murphy Orlando LLC in this case.

• Read the complaint in Hough v. Becerra, Case No. 3:22-cv-06687-ZNQ-LHG at https://medicareadvocacy.org/wp-content/uploads/2022/12/Hough-Complaint-.pdf