New Paper Urges CMS to Reconsider Anti-Obesity Medications as Treatment for Chronic Disease

Manatt Health, the Obesity Action Coalition (OAC), and the Obesity Society have released a white paper that discusses the legal and health policy rationales for the Medicare Part D coverage of anti-obesity medications (AOMs). Currently, the Centers for Medicare and Medicaid Services (CMS) prohibits the outpatient use of AOMs under Medicare, pointing to a federal statute that excludes these agents for coverage when used for anorexia, weight loss, or weight gain and is referred to as the Statutory Exclusion, according to a statement.¹

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The paper states that CMS has the administrative authority to adopt AOMs under an alternative interpretation of the statutory exclusion, which would allow the medications to be covered over Medicare Part D, indicating that obesity is a chronic disease and should be recognized as such.¹

“Within the clinical literature, and among medical specialists, there's recognition that adipose tissue, which is the tissue that stores fat, is metabolically active. Obesity is a disease that has multiple causes and consequences, not limited to weight,” Michael Kolber, JD, health care partner at Manatt, Phelps, and Phillips, LLP, said in a press briefing. “Some medical specialty groups, in fact, have advocated for the use of a different term than obesity, they refer to it as ‘ABCD’—adiposity-based chronic disease— and while there's not uniform views on what the right terminology is, and we refer to it as the diseases as obesity, I think that that term ‘adiposity-based chronic disease’ reflects that it is a chronic disease, reflecting about adipose tissue, and that there's a lot of causes and consequences of it.”²

In the paper, the authors stated that the nature and understanding of obesity has evolved over the past few decades with increased research efforts. Obesity is now clinically recognized as a disease, with a greater focus on other symptoms beyond weight management. According to the paper authors, there are direct links from obesity to cardiovascular disease (CVD), type 2 diabetes (T2D), liver disease, certain cancer types, and other dieases.³

They emphasized that GLP-1 agonists have been proven effective at treating obesity and its associated comorbidities. The paper authors detailed the legal and policy rationales for CMS to consider these medications for inclusion in Medicare Part D. They stated that the AOMs do more than address weight loss, therefore, it is not prevented from being covered by the statutory exclusion.³ However, access to AOMs consistently remains a barrier to those with obesity.

“Approximately 1% to 3% of [those] have access to evidence based scientific obesity treatments. The importance of this report demonstrates that CMS has strong opportunity to use their administrative authority to change their coverage determination to improve access to care for older Americans,” Tracy Zvenyach, PhD, MS, RN, director of Policy Strategy and Alliances at OAC, said in the press briefing.²

Another argument the authors presented is around the significant improvements in efficacy and safety for the new generation of AOMs. They noted that the new class of medications do improve the condition significantly compared to medications from the 1990s. They said this calls for a reevaluation of AOMs that are used to treat obesity as a chronic disease, not just for weight loss, which would not fall under the statutory exclusion.³

“The paper calls on [the] FDA to update [obesity] guidance. Fortunately, in July of this year, [the] FDA did announce that this guidance is added to the list of documents that will be revisited, hopefully, in the course of this year. All of these together are actions that, again, as the paper points out, will hopefully lead CMS to adopt a more inclusive interpretation of the Statutory Exclusion,” Rachel Sher, JD, a health care partner at Manatt, Phelps, and Phillips, said in the press briefing.²

References

1. New white paper demonstrates legal and policy rationale for Medicare Part D coverage of anti-obesity medications, including alignment with clinical guidelines, existing precedents, and Biden Administration priorities. News release. Rational 360. September 25, 2023. Accessed September 25, 2023. Email.
2. Kolber M, Sher R, Zvenyach T. Media briefing: Manatt Health white paper on Medicare Part D coverage of anti-obesity medications. September 25, 2023. Accessed September 25, 2023.
3. Kolber M, Sher R, Weinstein D. Anti-obesity medications as Medicare Part D drugs legal and health policy rationales. Manatt Health. September 25, 2023. Accessed September 25, 2023. https://www.manatt.com/Manatt/media/Documents/Pfizer_Obesity-Drugs-Part-D-Coverage_2023-09_c.pdf