Diabetes is a chronic health condition that affects how the body produces or uses insulin, the hormone that regulates blood sugar.¹  In the US, 34.2 million adults have diabetes, and 1 in 5 are unaware of their diagnosis.² Medication is a mainstay in diabetes treatment, and a wide variety of medication classes are used to manage the disease.  

Certain classes, particularly glucagon-like peptide-1 (GLP-1) receptor agonists and the closely related glucose-dependent insulinotropic peptide-1/glucagon-like peptide (GIP/GLP-1) receptor agonists, have recently received US Food and Drug Administration (FDA) indications for weight loss in addition to diabetes treatment. These weight loss effects have drawn substantial media attention: GLP-1 receptor agonists such as semaglutide, branded as Ozempic and Wegovy, have become household names following high-profile celebrity endorsements and social media exposure, driving increased demand from patients and even triggering supply shortages in early 2022.³  

As these new indications drive new patterns of use, it is important to understand how medications used both to treat diabetes and weight loss affect quality measures focused on diabetes medication. 

What is semaglutide, and how does it work? 

Semaglutide injections were first approved by the FDA in 2017 for the treatment of diabetes, and were released under the brand name Ozempic.⁴ Semaglutide works to lower blood sugar levels and regulate insulin in individuals with Type 2 diabetes.^{5, 6} It also imitates a hormone naturally produced in the gut, glucagon-like peptide-1, thereby reducing appetite and signaling the body to feel full, as well as prompting the stomach to empty at a slower pace.  

As a result, individuals with obesity and accompanying health concerns were shown to lose weight while taking semaglutide. In response to research presented to the FDA, a higher dose of semaglutide was approved for the treatment of obesity under the brand name Wegovy in 2021.⁶  

As a result, two separate branded semaglutide products currently exist: Ozempic, indicated for diabetes treatment, and Wegovy, indicated for weight loss. 

How does this impact PQA’s diabetes-related measures? 

PQA stewards a number of quality measures that address medication treatment for individuals with diabetes. And importantly, many PQA health plan performance measures, such as Proportion of Days Covered: Diabetes All Class (PDC-DR) and Statin Use for Persons with Diabetes (SUPD), are specified using prescription claims to identify the eligible population, rather than diagnoses from medical claims.^{7, 8} This is because Medicare stand-alone prescription drug plans subject to the Medicare Part D Star Ratings do not have timely access to medical claims, resulting in concerns about actionability and fairness. 

To account for situations like Ozempic or Wegovy where a given target ingredient may have different products with different indications, PQA’s medication lists for diabetes quality measures only include products with an FDA indication for diabetes. For example, since Ozempic has an FDA indication for diabetes treatment and not weight loss, Ozempic is included as a target medication for the PDC-DR and SUPD measures. In comparison, Wegovy has an FDA indication for weight loss and not diabetes treatment and is therefore not included in the measures as a target medication. This logic is consistently applied to other GLP-1 and GIP/GLP-1 receptor agonists (and other medication classes) with similar situations. 

Medications with crossover between diabetes treatment and weight loss can be confusing. To help clarify, the table below illustrates current GLP-1 and GIP/GLP-1 receptor agonists, along with their FDA-approved indications, and shows whether or not they are included as target medications in the PDC-DR and SUPD measures. 

How does the prescribing of diabetes medications for off label treatment of obesity impact performance on PQA measures within the Medicare Part D Star Ratings program? 

It is important to note that the Centers for Medicare & Medicaid Services (CMS) does not cover medications used for weight loss under the Medicare Part D benefit (based on section 1927 (d)(2) of the Social Security Act).⁹ Given this, when Ozempic (or any other diabetes medication) is used for weight loss in individuals who do not have diabetes, it should not be billed to Medicare. Therefore, we would not anticipate Medicare Part D claims to be generated in these instances, and individuals taking Ozempic strictly for weight loss would not be captured in the denominator of the PDC-DR or SUPD measures.   

For these reasons, health plans’ performance on PQA diabetes measures should not be impacted by off-label prescribing of GLP-1 and GIP/GLP-1 receptor agonists. PQA is committed to maintaining quality measures in a consensus-based manner that is consistent with both the most recent evidence and the rules and regulations of key quality programs. For more information about PQA’s consensus-based process, visit our website.