Securing Medicare Part D coverage for off-label treatments is a significant concern for rheumatologists and patients. Part D plans are prohibited from covering off-label uses unless the indication is supported by one of the two Medicare-approved compendia, Micromedex Drugdex and the American Hospital Formulary Service (AHFS) Drug Information. Without citation in one of these publications, Medicare patients are unable to access medically necessary, evidence-based treatments.
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After hearing from ACR members that Part D plans were denying coverage for mycophenolate for scleroderma, the ACR Insurance Subcommittee (ISC) of the Committee on Rheumatologic Care set to work getting this indication added the AHFS DI compendium. The ISC submitted a formal request and supporting references in October 2016. After a lengthy review process, this information was added to the compendium by electronic update in November 2019. The information will also be included in the 2020 print edition of AHFS DI available later this month.
Inclusion of this indication in AHFS DI will facilitate access to mycophenolate for patients with scleroderma. Part D coverage should be granted as of November 2019; however, if a denial is received, practices should appeal and include a copy of the updated AHFS DI mycophenolate monograph.
The ISC submitted a second request to AHFS DI this past fall on the use of mycophenolate for treatment of autoimmune interstitial lung disease. Editors are reviewing the submission and will consider this indication for future revisions to the AHFS DI compendium.
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