Case Study

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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Corporate Advice: Asset Deals – Advantages & Disadvantages

In the final Part Three of a three-part series on corporate transactions, we describe important considerations around structuring the sale of a business as an "asset" sale.

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Corporate Advice: Stock Deals – Advantages & Disadvantages

In Part Two of a three-part series on corporate transactions, we describe important considerations around structuring the sale of a business as a "stock" sale, including advantages and disadvantages compared to an "asset" sale.

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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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Safeguarding Independents: HLA Reverses PBM Termination on Appeal

PBMs are huge companies that often use their market power in an abusive and predatory manner. This case study and successful network appeal provides an example of why experienced PBM audit defense attorneys are necessary to hold PBMs legally accountable and protect your rights.

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Corporate Advice: Asset Deals vs. Stock Deals

In Part One of a three-part series on corporate transactions, we describe preliminary considerations around deal structure. In subsequent articles, we dive deeper into the advantages and disadvantages of asset sales versus stock sales.

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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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HLA's Coffey Appointed by Attorney General

HLA's Nancy Coffey, a former government official and healthcare expert, has been appointed to serve a three-year term as an independent pharmacy monitor for the Commonwealth of Massachusetts.

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State Board Declines Case Against HLA Client

PBM audits may result in collateral consequences, including licensing and disciplinary proceedings. In this case, HLA's experienced defense attorneys successfully convinced the State Board to decline further investigation, effectively resolving the matter at an early stage.

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HLA Wins Network Reinstatement for Illinois Pharmacy

PBMs are increasingly terminating pharmacies for minor infractions of the provider manuals or network enrollment forms. These terminations are contrary to the PBM's obligations under law and the parties' agreements, and may have collateral consequences if the underlying allegations involve wrongdoing. In this case, we profile the steps that led to a successful network reinstatement for an Illinois pharmacy.

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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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Firm Overview & Capabilities

In this article we profile the The Health Law Alliance, a specialized healthcare boutique with a team of experts in government investigations, PBM audits, payor disputes, licensing board matters, and regulatory advice. Industry peers note the extensive legal experience of the firm's founding partner and the diverse expertise of the team, positioning the firm to provide strategic and pragmatic solutions for clients facing challenges in the healthcare sector.

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Off-Label Prescribing and Dispensing: Ozempic, Wegovy, and Other Medications

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.

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OIG Accepts Healthcare Fraud Self-Disclosure by Physician and Physician Group

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.

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OIG Accepts Healthcare Fraud Self-Disclosure by Pharmacy

Health Law Alliance, under Anthony Mahajan's guidance, reports the successful acceptance of a self-disclosure for Delmar Pharmacy by OIG following a PBM audit identifying Humira dispensing discrepancies. The pharmacy's collaborative decision to disclose limits liability to $218,129.26, emphasizing Health Law Alliance's expertise in PBM audit defense and OIG self-disclosures.

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Inventory Shortfall Case Studies

Health Law Alliance, under Anthony Mahajan's leadership, celebrates favorable outcomes in federal and state cases involving inventory shortfalls, showcasing their expertise in PBM audit defense. Successful dismissals of criminal charges and reduced civil settlements highlight Health Law Alliance's strategic approach in resolving cases stemming from PBM audits.

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Defending Inventory Shortfalls

Health Law Alliance addresses the complexities of defending against inventory shortfalls in the context of PBM audits, emphasizing the common sources of discrepancies and potential legal implications. The article underscores the importance of a well-organized defense strategy to limit liability and navigate potential consequences for providers facing network suspension, administrative proceedings, civil lawsuits, or even criminal charges arising from inventory management errors.

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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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