Access to Anti-Obesity Medications: Ensuring the Full Continuum of Care for People Living with Obesity

April 2023

Obesity is an epidemic, but it doesn’t have to be. It is a preventable and treatable disease.

Background

More than two in five American adults live with obesity — and almost 50% of Black and Latino adults.[1] Obesity is a serious, progressive, chronic disease. It is also a major risk factor and the greatest contributor to a broad range of chronic conditions such as cardiovascular disease, type 2 diabetes, and hypertension; 47.1% of the total cost of chronic diseases nationwide can be linked to the disease of obesity.[2] Obesity is an epidemic,[3] but it doesn’t have to be. It is a preventable and treatable disease. In 2013, the American Medical Association recognized obesity as a disease with multiple pathophysiological aspects requiring a full range of interventions for effective treatment. While there are numerous public and private efforts to prevent obesity, treatment of obesity continues to lag, often due to stigma and prejudice against people living with the disease. A focused effort is needed to truly change the trajectory of the disease.

Although lifestyle and behavioral therapy remains a cornerstone of treatment for this disease, the use of anti-obesity medications (AOMs), along with bariatric surgery, produce greater and more sustained weight loss in treatment-approved populations as compared with lifestyle modifications alone.[4] This paper focuses on the considerable barriers to access to AOMs which range from the lack of proper training of medical professionals to the denial of insurance coverage for these life-saving medical interventions.[5]

AOMs have been improving dramatically. First generation AOMs resulted in patients losing 5% to 12% more weight than those whose obesity treatment protocol was confined to lifestyle changes;[6] new generation AOMs have produced weight loss of 15% to more than 20% in clinical trials.[7] AOMs also successfully sustain obesity reduction.[8]

However, these impactful tools to aid chronic weight management are not accessible to most Americans,[9] including Medicare beneficiaries; this leaves millions of people exposed to costly chronic illnesses and premature death due to lack of treatment.[10] The time to start changing the lack of insurance coverage of AOMs is now, starting with the vulnerable population covered by Medicare.

Medicare Is the Outlier Among Federal Payers

Food and Drug Administration (FDA) approved AOMs are a covered treatment option for individuals who receive health benefits from the Veterans Health Administration,[12] TRICARE since 2017,[13] and all Federal Health Employee Benefit (FEHB) plans since early 2022.[14] As recently as January 2023, the Office of Personnel Management reiterated that “FEHB carriers must have adequate coverage of FDA-approved anti-obesity medications on the formulary to meet patient needs.”[15] In more than a third of US states, Medicaid fee-for-service or managed care now covers AOMs. Similarly, State Employee Health Benefit plans in over half the states have updated coverage policies to ensure access to AOMs.

Medicare’s Lack of Coverage of AOMs Must Change

Obesity prevalence among older Americans is increasing at an alarming rate. In a single generation — between 1988-1994 and 2015-2018 — the share of U.S. adults ages 65 and older with obesity nearly doubled, increasing from 22% to 40%.[16] Within the Medicare population, obesity impacts communities of color most severely. The seriousness of that fact must drive action.

CMS has expressed the importance of treating the disease of obesity, the related comorbidities, and addressing stark health disparities; however, Medicare Part D does not cover FDA-approved AOMs. This CMS policy is divorced from the standard of care AND is based on an outdated interpretation of a general exclusion for “weight-loss” medications put in place over 15 years ago. In contrast, bariatric surgery is covered under Medicare Part B. Clearly, these policies are not in sync because CMS’ coverage of bariatric surgery is conditioned on the failure of other interventions, including pharmacotherapy.

The American Medical Association updated its policy in 2022 with a comprehensive plan to address obesity and break down barriers to care which included working “to remove out-of-date restrictions at the state and federal level prohibiting healthcare providers from providing the current standard of care to patients affected by obesity.”[17] Despite this mounting pressure, CMS has yet to update its coverage standard to keep pace with the science and best practice.[18]

Paths to Provide AOM Coverage to Medicare Beneficiaries

Legislative Path. Lawmakers could respond to the medical advancements over the past 20 years and amend the Social Security Act to clarify that FDA-approved AOMs that treat the chronic disease of obesity are medically necessary treatments for “chronic weight management” and therefore eligible for coverage under Medicare Part D. Since 2012, a large number of bipartisan members of Congress have cosponsored legislation that would make this change.[19]

Regulatory Path. CMS’s policy to exclude AOMs from Part D coverage was adopted in the preamble to a 2008 Part D final rule and can therefore be reversed through similar guidance.[20] CMS could use its interpretive authority to re-examine the exclusion of AOMs and permit coverage of these FDA-approved medicines to treat the chronic disease of obesity, while continuing to exclude therapies for weight loss. This action would build upon the 2022 Labor Health and Human Services Appropriations report language which reminded CMS that “access to obesity treatment, including anti-obesity medication, is an important part of the Administration’s effort to combat chronic disease, reduce health care costs, and improve care” and “encourage[d] CMS to ensure access to treatments for obesity in Part D by clarifying [in the regulation’s prohibition of coverage] that an agent for ‘weight loss’ does not include an FDA-approved anti-obesity agent as classified by the United States Pharmacopeia Drug Classification system.”[21]

CMS Has the Regulatory Authority to Act. CMS has the authority to provide coverage for FDA-approved AOMs in order to appropriately address obesity and the myriad of other diseases linked to it. Section 1927(d)(2)(A) of the Social Security Act does not forbid coverage of AOMs; instead, it clearly states that the Secretary “may [exclude] from coverage or otherwise restrict … agents when used for anorexia, weight loss, or weight gain.”[22] By using the term “may” instead of “shall”, Congress unambiguously intended to authorize exclusion of such drugs, but did not mandate their exclusion.[23] Instead, the permissive language of “may” grants the Secretary the authority to provide coverage of AOMs to address the disease of obesity.

An example of such Secretarial discretion is CMS’ 1999 decision to cover SEROSTIM,® even though this drug is indicated for weight gain. CMS used its authority to interpret the statute and deem coverage appropriate because the treatment promoted weight gain and was used to combat wasting in patients with AIDS, thereby improving outcomes and reducing morbidity and mortality for those patients.[24] That same rationale should apply to FDA-approved AOMs which address a patient’s weight while also contributing to improvement of a range of comorbidities, symptoms, and health risks associated with the disease of obesity.[25] CMS should recognize the crucial role that AOMs play in the context of treating obesity and differentiate between general “weight loss” drugs and FDA-approved treatments for chronic weight management or obesity.

Maintaining a policy that prevents Medicare patients from accessing these FDA-approved drugs is: 1) inconsistent with the standard of obesity care; 2) fails to utilize effective medicines to address comorbidities; 3) increases avoidable costs to the federal government; and 4) is detrimental to the health of seniors.

Standard of Care = Access to Anti-Obesity Medications

FDA-approved AOMs are now a standard-of-care tool used to treat the chronic disease of obesity and improve related comorbidities. Federal policy must change; Medicare coverage of AOMs would offer life-changing treatment for beneficiaries and lead the way for all insurers to provide access to these critical medications.[26]