Biden Proposes Rule to Allow Medicare, Medicaid to Cover Antiobesity Drugs

President Joseph R. Biden is proposing a new rule to expand Medicare and Medicaid coverage for anti-obesity medications. Currently, Medicare Part D is does not offer coverages for weight loss medications. But Medicare does provide coverage for GLP-1 therapies for patients who have diabetes or other medically accepted indications.

In a briefing, the White House said Medicare would expand access and reduce out-of-pocket costs by about 95% for some enrollees for antiobesity medications. Approximately 4 million adult Medicaid enrollees would also gain new access to these medications through this rule. The coverage for obesity drugs is part of a larger proposal for contract year 2026 for Medicare Advantage plans and for Part D.

Patrick Cooney

Whether this proposed rule actually has any impact remains to be seen, however, especially since CMS is accepting comment through Jan. 27, 2025, after President Donald Trump has been sworn in for this second term.

“The proposed rule is a significant step forward for those suffering from obesity,” Patrick Cooney, president of the lobby group The Federal Group, said. “However, I believe the Trump Administration is likely to take a new look at this issue due in part to cost and may come to a different conclusion than the Biden Administration. The comment period for this proposed rule ends in the first week of the new administration.”

Leslie Isengger

The Biden Administration’s act of issuing this rule is “typical of the ‘midnight rulemaking’ trend we’ve seen in the final days of outgoing Administrations and aligns with Biden’s desired legacy of reducing drug costs,” said Leslie Isengger, practice leader, corporate pricing and public affairs at Real Chemistry. “Finalizing the rule before the administration change seems unlikely, but issuing the rule could open a public comment process for stakeholders to weigh in on the importance of these medicines in managing cardiometabolic disease, engaging widespread advocacy for expanded access that the incoming leadership will have to manage.”

In a Federal Register announcement, the Biden administration said reinterpreting a Medicaid effort, National Strategy on Hunger, Nutrition, and Health, for coverage of obesity medications offers another tool for beneficiaries of Medicare and Medicaid. If this rule is finalized, Medicare and Medicaid would no longer exclude weight loss drugs, including glucagon-like peptide-1 (GLP-1s), that treat obesity.

CMS officials said in the Federal Register Notice said this would not be a change to provide coverage of any weight loss drugs for anyone who wants to lose weight but only for those beneficiaries who are obese.

This rule change for obesity drug coverage is part of broader effort by Biden to ensure Medicare Advantage and Medicare Part D continues his efforts to address drug costs. The Federal Register announcement also asked for comment about improving experiences for dual eligible enrollees, improving reporting and oversight of medical loss ratios, putting guardrails around the use of AI and strengthening prior authorization and utilization management guardrails.

Xavier Becerra

“We want to remove barriers that delay care or deny people services and medications they need to be healthy. In addition, we continue to promote competition for pharmacies and other health care businesses,” HHS Secretary Xavier Becerra said in a news release.

An estimated 42% of the U.S. population has obesity, which increases the risk of developing diabetes, cardiovascular disease, stroke and some cancers. But the GLP-1 drugs without insurance have a high price. Zepbound (tirzepatide), for example, is available for a list price of $1,059.87 a month, which is about 20% lower than Wegovy (semaglutide).

A study earlier this year from KFF found that about 12% of adults have used GLP-1 drugs either to treat diabetes or to lose weight. According to the KFF Health Tracking Poll, of those who report taking the GLP-1 drugs, 43% have diabetes, 26% have heart disease and 22% have obesity or overweight (22%).

Data continue to be released about the potential benefit of drugs such as semaglutide and other GLP-1 agonists. Earlier this month, for example, data from two separate phase 3 trials were released that showed that semaglutide improved fatty liver disease and reduced hospitalizations related to cardiovascular risk in obese patients. In the ongoing ESSENCE trial, 37% of the 800 adults with metabolic dysfunction-associated steatohepatitis (MASH) achieved improvement in liver fibrosis. Novo Nordisk expects to file for regulatory approvals in the United States and European Union in the first half of 2025.

Related: GLP-1 Benefits For People With Ulcerative Colitis and Obesity

Additionally, a study presented last month at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting in Philadelphia found that GLP-1 drugs could have additional benefits for people with obesity and ulcerative colitis.

In March 2024, Medicare announced it would allow Part D plans to cover semaglutide for people with a BMI of 27 or higher with cardiovascular disease, regardless of whether they have diabetes. This was based on Wegovy’s approval to reduce the risk of cardiovascular death, heart attack and stroke in adults with cardiovascular disease and either obesity or overweight. The SELECT trial showed that semaglutide was associated with a 20% reduction in cardiovascular symptoms in obese people.

Isengger said the “focus on expanding access to Medicare and Medicaid patients for obesity suggests that the Biden Administration expects President-Elect Trump’s nominations to be confirmed — and that they are taking seriously the MAHA [Make America Healthy Again] platform, which questions the efficacy of and reliance on (approved) prescription drugs, with GLP-1s being a named target.”

Incoming President Donald Trump has named several controversial appointments for healthcare positions in the new administration, including Mehmet Oz, M.D., the famous television show doctor to serve as CMS administrator. Although weight loss was a popular topic on his show, Oz frequently recommended supplements such as green coffee extract.