Healthcare Fraud

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.

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

On the heels of federal criminal investigations into OTC card usage, payors are now auditing OTC processes and imposing severe sanctions, including network termination, for non-compliance. Pharmacies should be wary of increased enforcement in this area and take steps to proactively reduce audit risk.

PBM audits must be handled correctly or severe consequences may result. In this case, HLA was able to persuade prosecutors not to file criminal charges against the pharmacy's owner, but a subsequent civil resolution still involved harsh penalties. It could have been far worse.

Following a PBM audit that uncovered a $6.5 million billing discrepancy, federal prosecutors opened an investigation. After HLA was retained, the U.S. Attorney's Office for the Eastern District of Pennsylvania agreed to a $2.5 million civil settlement in which the Owner denied all wrongdoing.

Health Law Alliance has successfully challenged OptumRx'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.

Providers need to know their rights when it comes to investigations and audits by CMS UPIC contractors, such as SafeGuard and Qlarant. These investigators are private citizens, with no more authority or power of law than anyone else. Yet, they often employ traditional law enforcement techniques. Don't be fooled.

The federal government continues to bring enforcement actions relating to false prior authorizations given the high-priced medications typically involved. In this case involving Walgreens, we take a deeper dive into potential theories of liability and the use of civil investigative demands and subpoenas in healthcare fraud cases.

Department of Justice prosecutors continue to file numerous cases against pharmacies and their owners for inventory shortfalls and other discrepancies. These cases arise out of referrals by government contractors following a pharmacy audit, and often involve severe potential consequences.

Based on a recent announcement, the federal government (HHS-OIG) will be prioritizing audits of pharmacy claims in 2024. This further signals that pharmacy audits from all angles are on the rise.

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.

Federal prosecutors are expanding a healthcare fraud investigation, charging New York pharmacy owners and employees for violations related to OTC card practices. Health Law Alliance, led by Anthony Mahajan, emphasizes the severity of charges, urging providers to act promptly to limit exposure.

Anthony Mahajan, an attorney at Health Law Alliance, contends that Novo Nordisk's recent lawsuits against Florida compounding pharmacies to stop semaglutide compounding are baseless attempts to limit market availability and intimidate compounders. Mahajan highlights the legality of semaglutide compounding under Sections 503A and 503B of the FD&C Act, emphasizing that Novo's arguments lack substance and should not intimidate semaglutide compounders who play a crucial role in meeting patient needs.

Health Law Alliance's Anthony Mahajan discusses the potential outcomes and strategies related to Pharmacy Benefit Manager (PBM) audits, emphasizing the importance of understanding the intersection between government enforcement actions and PBM audits. With unmatched experience in PBM audit defense, Mahajan highlights the firm's achievements in resolving cases involving inventory discrepancies and government investigations, offering comprehensive solutions to protect clients against potential liabilities.

Federal prosecutors have decided not to prosecute the CEO of a Florida specialty pharmacy, represented by Health Law Alliance's Anthony Mahajan, in connection with an alleged healthcare fraud scheme involving Evzio. The successful defense resulted in an innovative $1.3 million civil settlement, avoiding criminal charges and exclusion from federal programs.

Federal prosecutors are now pursuing felony charges under Section 1035 for false statements in pharmacy audits, extending the risk of criminal prosecution for healthcare providers. Recent cases highlight the importance of legal counsel, such as HLA's experienced attorneys, to safeguard against potential legal consequences.