Prepared by: Carlos Arce, Esq.
You’ve seen the ads and you know the jingle, Oh! Oh! Oh! Ozempic. Yes, we are talking about the famous diabetic drugs, Ozempic (semaglutide) and Mounjaro (tirzepatide) (hereinafter “GLP’s”), administered through injections for patients with Type 2 diabetes. However, that’s not how the public views it and that’s not how many health providers have approached its prescriptions. This article focuses on the issues surrounding the prescription risks of these drugs for cash clinics (med spas, regenerative medicine, and concierge medicine), primary care providers who do cash services and take insurance or submit prescriptions which are reimbursed by insurance.
The “Trend”
Healthcare providers have created a spike in the utilization of GLP’s for theirwell-knownoff-label use, weight loss. Pharmacies are experiencing a shortage, insurance companies are experiencing an increase in prescription approvals and reimbursement, and the government has a close eye on the situation. The FDA approvedOzempic back in December of 2017, and Mounjaro in May of 2022. Since then, GLP’s have been in the limelight, and desire from the public has created huge demand. Patients are asking their providers to prescribe these GLP’s in wellness visits with primary care physicians and other patients are paying top dollar cash for “nutritional visits” which include the approval and prescribing of these drugs.
The Insurance Police (“Special Investigation Units”)
The recent article from Becker’s Payer Issues, has released data showing many of the top commercial payors in the United States are waging war against off-label prescriptionsfor these drugs. Payers such as Anthem Blue Cross have sent letters to providers warning them of prescribing GLP’s for off-label use. Language contained in those letters raises False Claims Act territory,“The Special Investigations Unit has completed a comprehensive review of your prescription and professional claims,” a letter to a Missouri physician said. The letter said 60 percent of patients prescribed Ozempic lacked “sufficient evidence” of diabetes and that Anthem would refer “suspected inappropriate or fraudulent activity … to the state licensure board, federal and/or state law enforcement,“; a quote provided by the Washington Post who reviewed a hand full of these letters sent by Anthem.
The Standard of Care (“Compliance”)
The question often comes up from clients who services cash patients whether they need to adhere to the certain regulatory requirements which are more commonly followed in insurance-based practices. The short answer is yes. Cash practices must follow the same regulatory compliance guidelines when treating patients as not only adherence to the law but also for the safety of their patients. Patients are begging their providers for these drugs, and providers aren’t documenting as they should. One of the key ingredients to compliance is having “policies and procedures”. If
[1]Payers Crack Down on Ozempic Prescriptions, Jakob Emerson, June 12, 2023. https://www.beckerspayer.com/payer/payers-crack-down-on-ozempic-prescriptions.html?origin=BHRE&utm_source=BHRE&utm_medium=email&utm_content=newsletter&oly_enc_id=8685H6122145J1S
providers are following the proper methods under the standard of care, they shouldn’t have a problem explaining why they are prescribing certain drugs to patients. If you perform a thorough office visit, and the patient has diabetic symptoms or potential diabetic concerns, is it not reasonable to send said patient for blood work, and if that blood work shows and proves diabetic traits would, GLP’s be considered the proper treatment? The answer is it all depends on what providers in the community deem to be the appropriate level of treatment or care.
Attorney Carlos H. Arce works with the Florida Healthcare Law Firm in Delray Beach, FL. He has deep experience with health law, business law, and mergers & acquisitions. Carlos has handled multi-million-dollar healthcare transactions and has served as out-of-house counsel to various small to large healthcare entities. He can be reached via email at [email protected] or by calling 561-455-7700.
