Doctors

The semaglutide industry is relatively new, and significant regulatory enforcement typically lags by at least two years. Accordingly, all participants involved in the semaglutide supply chain should implement well-designed compliance programs now to reduce the risk and severity of future regulatory action.

Intense semaglutide demand has now drawn the attention of regulators beyond the Food & Drug Administration (FDA) and state boards. Last month, a woman was charged by federal prosecutors with violations of criminal law related to misbranded and adulterated weight loss drugs. This prosecution marks the first of many to come.

Express Scripts is targeting prior authorization Fraud, Waste & Abuse involving the use of CoverMyMeds provider accounts by pharmacies. Pharmacies and physicians beware.

DEA registration applications are receiving increased scrutiny as DEA turns its sights on providers and pharmacies to curtail controlled substance misuse and abuse. Applicants can and should take steps to ensure the registration process moves as quickly and smoothly as possible.

Although DEA has long targeted wholesalers as the "choke-point" for stemming diversion, the Agency has now shifted its focus to downstream physician and pharmacy registrants. Providers who thought they understood DEA risk need to revisit their planning because the enforcement paradigm has changed dramatically.

Anthony Mahajan delves into the intricacies of off-label prescribing and dispensing for medications such as Ozempic, Wegovy, and Rybelsus. Mahajan discusses legal nuances applicable to manufacturers, physicians, and pharmacists, offering practical guidance for healthcare providers to manage off-label exposure effectively.

Health Law Alliance, led by Anthony Mahajan, announces the acceptance of a self-disclosure by OIG on behalf of Shore Orthopaedic University Associates, limiting liability to $333,645.83 for Medicare claims involving an unapproved code for Fluid Flow. The success underscores Health Law Alliance's expertise in OIG self-disclosures and the intricate decision-making process surrounding voluntary disclosures.