Legal Insights

Health Law Alliance's Anthony Mahajan is pleased to announce the complete dismissal of a lawsuit brought on behalf of the federal government against a cancer care provider for the submission of false Medicare claims for oncology drugs.

Health Law Alliance announces the filing of an emergency lawsuit in federal court for the Northern District of Texas, Dallas Division, to stop Optum's termination of an independent pharmacy that dispensed medications on telemedicine prescriptions and force Optum to comply with federal and state "prompt payment" laws that prohibit withholding of reimbursement.

The Federal Trade Commission (FTC) plans to sue the top Pharmacy Benefit Managers (PBMs) for anti-competitive practices, including influencing drug prices and favoring their own networks, which disadvantage independent pharmacies and raise prescription drug costs.

Health Law Alliance has successfully challenged Optum Rx's termination decisions for numerous pharmacies, ensuring they can continue to operate and serve their communities. These victories highlight the firm's expertise in healthcare law and its dedication to protecting pharmacy clients from unjust PBM actions.

The top Pharmacy Benefit Managers (PBMs) are condemned by the FTC for manipulating the healthcare system to generate significant profits, thereby inflating drug costs and overcharging patients, particularly for critical medications like cancer drugs.

Ozempic, a well-known medication for type 2 diabetes, has gained popularity for its off-label use in weight loss, leading to increased scrutiny by authorities. Recently, U.S. Customs and Border Protection (CBP) officers in Cincinnati seized several shipments of the drug, underscoring the growing demand and associated risks.

There has never been a more fortunate time for compounding pharmacies looking to capitalize on the "Gold Rush" of Ozempic. Due to the forecasted limited supply of the brand name drug, the FDA has put Ozempic on the shortage list, which will allow for a more accommodating set of rules regarding compounding and distribution of semaglutide-based drugs.

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.