Commissioned by Pfizer Inc.

Obesity is a complex, multifactorial disease that has serious health consequences, affects millions of Americans and drives hundreds of billions of dollars in annual health care spending. Scientific understanding of the nature of obesity has evolved over the course of the last few decades. It is now clinically recognized that obesity is a disease, not simply a cosmetic concern or issue of personal behavior. We now have a much greater understanding of obesity’s various metabolic implications and direct links to cardiovascular disease, type 2 diabetes, liver disease, and certain types of cancer, among other diseases. Multiple prescription medications have been developed, approved and recognized as safe and effective for long-term use in treating obesity. However, the Centers for Medicare & Medicaid Services (CMS) has historically prohibited coverage of these drugs under Medicare Part D, citing a decades-old federal statute excluding “agents when used for anorexia, weight loss, or weight gain” (the Statutory Exclusion).

In a white paper commissioned by Pfizer Inc., Manatt Health, with contributions from the Obesity Action Coalition (OAC) and The Obesity Society (TOS), summarizes the legal and policy rationales for CMS to alter its interpretation and concludes that the Statutory Exclusion does not prevent Part D coverage of AOMs. Put simply, obesity treatment, including use of AOMs, is not treatment solely for weight loss and the Statutory Exclusion need not prevent Part D coverage of AOMs on the basis of their weight loss properties.

The white paper concludes that by adopting a more inclusive interpretation of the Statutory Exclusion, CMS can enable more appropriate, comprehensive and patient-centered treatment of obesity and related comorbidities while reducing stigma and access barriers faced by beneficiaries.

To read the full Manatt Health white paper, in collaboration with the OAC and TOS, click here.