Legal Insights

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.

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.

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.

PBM audits can be resolved successfully, but more frequent and aggressive audits will require careful planning. Providers should avoid reactive behavior. Strategic planning for audit resolution should be made from audit inception to proactively manage audit risk effectively.

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.

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.

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.

The transition of Medicaid pharmacy benefit to NYRx in New York brings increased dispensing fees but also heightened audit and enforcement risks, with potential scrutiny from OMIG and HHS-OIG, warns Health Law Alliance led by Anthony Mahajan.