Healthcare Fraud

Semaglutide Compliance Program: A Must Have

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.

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Federal Prosecutors Focus on Ozempic Violations

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.

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Express Scripts FWA Investigative Alert: Crackdown on CoverMyMeds Provider Accounts

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

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OTC Enforcement Update and PBM Audit Alert

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.

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MFCU Agrees Not to Charge HLA Client Following PBM Audit Referral

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.

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Federal Prosecutors Decline Criminal Prosecution of HLA Client

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.

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HLA Wins Dismissal of Criminal Charges After PBM Audit

Following a PBM audit that noted huge inventory discrepancies, the Massachusetts Attorney General's Office indicted the pharmacy and its owner, then represented by a different law firm. After HLA was retained, all charges were dismissed.

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SafeGuard Audits: Don't Let CMS's Contractor Infringe Your Rights

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.

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Walgreens Must Face Lawsuit Based on False Prior Authorizations

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.

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DOJ Maintains Focus on Inventory Shortfalls

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.

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HHS-OIG Prioritizes 2024 Pharmacy Audits

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.

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DEA's Dangerous New Agenda

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.

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Federal Investigation for OTC Cards is Expanding

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.

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Novo Nordisk’s Recent Lawsuits to Stop Semaglutide Compounding are Baseless

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.

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How PBM Audits Can Provoke Government Scrutiny

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.

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Federal Prosecutors Drop Criminal Charges Against Specialty Pharmacy Owner Relating to False Prior Authorizations

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.

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Audit-Related Prosecutions Rise Sharply

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.

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