The warning letters, first reported by The Washington Post, include threats such as the possibility of reporting “suspected inappropriate or fraudulent activity ... to the state licensure board, federal and/or state law enforcement.”
It’s the latest chapter in the story of the popular, highly effective, and very expensive drug intended for diabetes that results in quick weight loss. Off-label prescribing means a medicine has been prescribed for a reason other than the uses approved by the Food and Drug Administration. The practice is common and legal (the U.S. Agency for Healthcare Research and Quality says one in five prescriptions in the U.S. are off label).
But insurance companies are pushing back because many do not cover weight loss medications, while they do cover diabetes treatments. The insurance company letters suggest that prescribers are failing to document in a person’s medical record that the person actually has diabetes.
Ozempic, which is FDA approved for treatment of diabetes, is similar to the drug Wegovy, which is approved to be used for weight loss. Ozempic typically costs more than $900 per month. Both Wegovy and Ozempic contain semaglutide, which mimics a hormone that helps the brain regulate appetite and food intake. Clinical studies show that after taking semaglutide for more than 5 years, people lose on average 17% of their body weight. But once they stop taking it, most people regain much of the weight.
Demand for both Ozempic and Wegovy has been surging, leading to shortages and tactics to acquire the drugs outside of the United States, as well as warnings from public health officials about the dangers of knockoff versions of the drugs. The Centers for Disease Control and Prevention says 42% of people in the United States are obese.
“Obesity is a complex disease involving an excessive amount of body fat,” the Mayo Clinic explained. “Obesity isn’t just a cosmetic concern. It’s a medical problem that increases the risk of other diseases and health problems, such as heart disease, diabetes, high blood pressure, and certain cancers.”
A version of this article first appeared on WebMD.com.