Pharmacy Defense

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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Increased Scrutiny for DEA Registration Applications

DEA registration applications are receiving increased scrutiny as DEA turns its sights on providers and pharmacies to curtail controlled substance misuse and abuse. Applicants can and should take steps to ensure the registration process moves as quickly and smoothly as possible.

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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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Medicare Advantage Cuts to Increase PBM Pressures

Insurers have bet big on Medicare Advantage, but the government is slowly cutting back. Faced with rising medical loss ratios and CMS reimbursement cuts, payors and their PBMs are planning to make up those losses by increasing pharmacy claims audits and unilateral recoupments.

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Pharmacy Alert: Texas Board of Pharmacy Investigations

Texas pharmacies are facing increasing scrutiny by the Board of Pharmacy, which is working closely with the DEA and other federal agencies, to investigate regulatory violations and Medicaid claims.

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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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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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PBM Audit Response Summary

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.

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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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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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Semaglutide Compounding Pharmacies Subject to Increasing Regulatory Threats

Semaglutide compounding pharmacies face regulatory threats as state boards interpret statutes restrictively; Health Law Alliance, led by Anthony Mahajan, emphasizes broader permissions, countering misinterpretations.

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Health Law Alliance Recovers More than $20M Unlawfully Seized from Clients by Financial Institutions

Health Law Alliance, with Anthony Mahajan at the helm, recovers $20M+ unlawfully seized by financial institutions, highlighting potential illegality in account restraints and urging clients to seek immediate counsel for asset freezes.

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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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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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