Lilly Criticizes CMS Decision to Exclude Obesity Drugs from Medicare Part D

CMS Final Rule Omits Weight-Loss Medications

The Centers for Medicare and Medicaid Services (CMS) has reaffirmed its long-standing policy to exclude anti-obesity drugs from Medicare Part D coverage, prompting strong opposition from pharmaceutical giant Eli Lilly. In an open letter published on Wednesday, Lilly criticized the decision, asserting that it jeopardizes the quality of care for patients suffering from obesity and related health conditions.

In the letter, Lilly stated,We don’t believe this is right, adding that,In an environment where people with obesity often struggle to access obesity management medications, these abrupt changes only make things more difficult.

Implications for Providers and Patients

The company accused CMS of making "payer-driven" decisions that interfere with the autonomy of healthcare providers. According to Lilly, such exclusionsundermine a health care provider’s ability to choose the most appropriate treatmentsand could disrupt care not only for those with obesity but also for individuals with comorbid conditions like obstructive sleep apnea.

The CMS ruling, finalized last month, outlines Medicare Advantage and Part D coverage updates effective January 1, 2026. Notably absent are newer anti-obesity medications like Lilly’s Zepbound and Novo Nordisk’s Wegovy, despite both having received FDA approval for indications related to other health conditions. For example, Zepbound was approved in December 2024 for obstructive sleep apnea, leading to CMS coverage for that specific use.

Legislative and Regulatory Context

Historically, Medicare Part D has not covered medications indicated solely for weight-loss. To work around this, manufacturers have sought secondary approvals. Novo Nordisk, for instance, has focused on obtaining cardiovascular risk indications for Wegovy.

However, in November 2024, the Biden administration proposed a policy change to permit Medicare Part D to cover anti-obesity drugs directly. This proposal aimed torecognize obesity to be a chronic disease based on changes in medical consensusandensure more Americans have access to these medications.

Cost Concerns and Future Outlook

Despite these developments, CMS remains cautious. A spokesperson for the agency remarked last month that extending coverage to anti-obesity medications isnot appropriate at this time, though future changes remain possible depending on cost-benefit analyses.

Cost implications are a significant factor in the decision. A report from the Congressional Budget Office (CBO) released in October 2024 estimated that including these drugs in Medicare coverage could increase federal spending by approximately $35 billion between 2026 and 2034. The CBO also noted that anticipated savings from improved health outcomes would likely be minimal.

Highlights

• The CMS has excluded anti-obesity drugs from Medicare Part D in its 2026 rule, drawing criticism from Eli Lilly.
• Lilly contends the decision limits access to necessary care and interferes with provider autonomy.
• Medicare continues to deny coverage for weight-loss drugs unless they are approved for other indications.
• Zepbound and Wegovy remain uncovered for obesity, despite FDA approvals for related conditions.
• The Biden administration proposed a rule in November 2024 to allow coverage of anti-obesity drugs, but CMS has not adopted it.
• The Congressional Budget Office estimates a $35 billion cost for Medicare coverage of these medications through 2034.