Key Takeaways
- The proposed rule for Medicare to cover anti-obesity medications seems similar to one that emerged as Medicare Part D was being implemented, but was scraped.
- Some incoming Trump Administration officials have suggested the regulation may die once they take office.
- But the business dealings and statements from Trump’s expected CMS and FDA leadership nominees suggest there may be some inclination to allow the regulation to remain in place.
A back-to-the-future component seems evident with the US Center for Medicare and Medicaid Services’ November proposal to provide coverage for anti-obesity medications in the Medicare and Medicaid programs.
CMS essentially is trying to adopt a policy originally floated before Medicare Part D launched in 2006. The agency proposed that drugs treating “morbid obesity” should be covered by Part D, drawing a distinction with the statutory language excluding “weight loss” drugs. Notably, the proposal was made by a Republican administration that generally embraced a deregulation/limited government philosophy.
CMS backed away from the idea in the final guidance for the program. But the agency also made clear that plans still could provide coverage for obesity drugs in “enhanced” Part D plans, a policy that governed Part D for almost 20 years.
Now CMS believes that the medical consensus has coalesced around its position from two decades ago.
“Given the changes in how the medical community has come to regard obesity as a disease since the start of the Part D program, CMS believes that its long-standing interpretation” of the weight loss exclusion “reflects an outdated medical understanding, and that it would be more consistent with current medical views to propose to reinterpret the phrase,” the proposed rule states.
The proposed rule’s timing feels deliberately provocative by the outgoing Biden Administration and will set an early test for Trump’s team on handling the politics of drug access and pricing in a high-profile category. Whether the rule moves forward will largely depend on whether the Trump health care team agrees that obesity is, in fact, a disease.
Trump’s expected HHS Secretary nominee, Robert F. Kennedy Jr., has criticized the GLP-1 weight loss category as a case study in over-medicalization to address chronic diseases. While Kennedy has not publicly commented on the proposed rule, one of his key advisers in the “Make America Healthy Again” campaign, Calley Means, called it “a declaration of war against American children and a betrayal of any American who cares about MAHA principles.”
The rule makes “Ozempic the standard of care for the 80% of Medicare recipients who are overweight or obese,” he wrote. “No incentives for healthy eating or exercise, straight to Ozempic … at a cost of $1,600 per month.”
Means then said the proposed rule applies to Medicaid, “which means that Ozempic will be the standard of care for the 40% of 12-year-olds who are overweight or obese.”
Ending the “drugging [of] kids on mass scale” is a rallying cry for the evolving Trump health care team, including Kennedy, expected CMS nominee Dr. Mehmet Oz, and Food and Drug Administration Commissioner pick Martin Makary.
Means said “the problem isn’t Ozempic itself,” but added the claim that “the drug destroys the pancreas, increases depression and eviscerates muscle mass.”
Ozempic “should exist,” Means said. “It is probably the right intervention for someone on the verge of death.”
But he argued that rather than covering the drug, federal programs should provide “flexible funds” for obese people to spend on lifestyle interventions if they choose.
The comments may sound like the death knell for the proposal come January when Trump takes office, but as with most things in the incoming administration, there are some crosscurrents in play.
On Capitol Hill, there is broad bipartisan support for expanding coverage for weight loss drugs, along with shared concerns about the cost. Many GOP legislators would likely applaud an administrative change allowing constituents to access the medicines without identifying cost offsets.
Oz offers “GLP-1” support products through his iHerb vitamin business. When announcing the new line, Oz suggested that he sees value in the weight-loss regiments.
“Incorporating GLP-1 support products into daily routines can enhance one’s health and wellness journey by making the side effects from treatment more manageable,” he said. “We take great pride in knowing that these scientifically backed offerings will allow people to live more comfortably, take the guesswork out of daily metabolic health, and ensure they stick to their treatment plan to achieve their desired results.”
In addition, Makary is chief medical officer of a telehealth company, Sesame, that offers compounded versions of GLP-1 agonists. While the position may be consistent with opposing the CMS rule on cost grounds, it suggests at least some support for the therapies as a medical intervention.
And then there is Elon Musk, co-chair of Trump’s “Department of Government Efficiency.” He has credited Wegovy with helping him get “fit, ripped and healthy.”
