AOMs and TROA
In the last year, the National Hispanic Council on Aging (NHCOA) has made clear that it is in favor of an expanded coverage of Medicare to include anti-obesity medications (AOMs). On a policy level, we see the path forward as largely being dependent upon the Treat and Reduce Obesity Act (TROA). TROA was introduced in July, 2023, with the intent of making concise inclusion of drugs under Medicare Part D coverage, when they have been approved by the Federal Food and Drug Administration (FDA) as specifically being an anti-obesity medication.
For a long time, there have been FDA approved drugs that could be called an AOM, however instead, they are described as “weight loss” medications. The implication here is that obesity is not being viewed as a chronic disease, and that weight management is something that ties into an individual’s other conditions, even though such conditions are frequently a by-product of obesity. This technical exclusion can be found under section 1860D-2(e)(2) of the Social Security Act.
On March 20th, 2024, CMS issued a memo regarding recent developments on the perspective of AOMs and their FDA approvals. The memo is given the subject line, “Part D Coverage of Anti-Obesity Medications with Medically Accepted Indications,” and in it CMS clarifies that if AOMs receive FDA approval for “an additional medically accepted indication,” then they can “be considered a Part D drug for that specific use.” What they’re saying here is that if an AOM can be prescribed for another condition other than obesity, then Medicare Part D will be able to cover it. For example, if an AOM is approved to treat diabetes, an obese individual who also has diabetes, will be able to receive the drug and still be covered by Medicare Part D.
To be clear, this is basically a CMS-sanctioned technical workaround for Part D recipients to access AOM, which shouldn’t be necessary. Patients should be able to receive AOMs to specifically treat their obesity, which is where TROA comes into play.
Why are AOMs important?
AOMs represent the pharmacotherapy side of obesity treatments. Generally, we are used to the idea of weight loss being related to changes in diet and exercise, which are nutritional and behavioral therapies respectively. While these areas of treatment are completely necessary and important to an individual’s fight with obesity, they are often not enough. It is common for these two types of treatment to show improvement, but not to the extent that would free the individual of the many health risks that come with being obese.
Individuals experiencing obesity are at much higher risk of cardiovascular disease, which is the leading cause of death in the United States. They are also at higher risk for type-2 diabetes, asthma, pulmonary blood clots, arthritis, stroke, many forms of cancer, and more.
How do they work?
The CMS memo referred to previously is in response to the growing presence of drugs that are composed of something called glucagon-like peptide 1 (GLP-1) agonists. GLP-1 is a hormone that aids in our digestion by stimulating insulin secretion (insulin is another key hormone, which basically turns the glucose in our bloodstream into energy for our cells). These GLP-1 agonists mimic the original hormone, to also trigger insulin secretion. AOMs that function as GLP-1 agonists are known to lower one’s appetite and prolong a sensation of fullness. Examples of such drugs include Ozempic, Wegovy, Zepbound, and Mounjaro, to name a few.
We need to fix our perspective on AOMs.
GLP-1 agonists have seen a dramatic increase in use. Most of us have heard of Ozempic as an agent of weight loss, specifically among celebrities, which could be part of the problem. These individuals are able to afford these drugs; they are not Medicare Part D beneficiaries, and are frequently not considered to be obese.
As a society, we have a tendency to see obesity as a manifestation of an individual’s unhealthy habits. This is a gross oversimplification that does a disservice to obese individuals, and to the field of medicine. An obese person can change their diet and increase exercise and still be afflicted; obesity is not simply a measure of weight, but a chronic disease with profound impact on one’s life.
Medicare Part D beneficiaries should be able to receive the drugs they need to live happy and healthy lives, and that includes AOMs.
References:
- “Part D Coverage of Anti-Obesity Medications with Medically Accepted Indications” (March 20, 2024). Centers for Medicare & Medicaid Services. https://www.cms.gov/about-cms/information-systems/hpms/hpms-memos-archive-weekly/hpmsmemos-wk-4-march-18-22
- Abram, Anna K et al. “Anti-Obesity Medications: Noteworthy Developments as Policymakers Weigh Coverage Considerations.” Akin Gump Strauss Hauer & Feld LLP. https://www.akingump.com/en/insights/alerts/anti-obesity-medications-noteworthy-developments-as-policymakers-weigh-coverage-considerations#authors
- “Top Weight Loss Medications.” Obesity Medicine Association. https://obesitymedicine.org/blog/weight-loss-medications/
- Abdi Beshir, Semira et al. “A narrative review of approved and emerging anti-obesity medications.” Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society vol. 31,10 (2023): 101757. doi:10.1016/j.jsps.2023.101757. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10497995/
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