Exploring Pharmaceutical Manufacturer and Specialty Pharmacy Relationships: What You Can and Cannot Do

    In an industry where supply chains are closely monitored, patient data is king, and complex medications require high-touch services by distribution partners, biologics and pharmaceutical manufacturers have turned to specialty pharmacies to assist. However, these arrangements are closely scrutinized and must be structured to ensure compliance with state and federal laws. In this webinar, attorneys Jesse C. Dresser, Esq., and John E. Morrone, Esq., provide an overview of the types of arrangements between manufacturers and specialty pharmacies and the legal and business considerations of those relationships. We will also examine the regulatory and payer risks and considerations. From this presentation, attendees will: Understand the types of contracts and arrangements entered into between manufacturers and specialty pharmacies Learn the legal and regulatory risks of pharma-pharmacy relationships through prior enforcement actions Identify the PBM contractual risks of entering into these arrangements Determine strategies to compliantly structure pharma-pharmacy relationships, including with respect to payment terms and appropriate services  If you have any questions or concerns regarding arrangements, or other issues with your specialty pharmacy, contact Frier Levitt today to speak to an attorney. Frier Levitt helps specialty pharmacies and life science companies on a routine basis deal with many issues including PBM …

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Overturned Conviction Casts Doubt on “Lack of Medical Necessity” to Support a Criminal Claim of Healthcare Fraud

By Kendra E. Pannitti, Esq., and Jonathan E. Levitt, Esq. Treating physicians and expert witnesses often have differing subjective viewpoints on the “medical necessity” for treatment or prescribing of drugs. But, when can a prosecutor’s belief that a physician’s decision “lacks medical necessity” support a finding of criminality? A recent Federal court decision may cast doubt on prosecutors’ legal theories relating to health care fraud cases involving alleged “lack of medical necessity.” Approximately six months after a jury convicted former cardiologist Dr. Richard Paulus of healthcare fraud, a Federal judge overturned that conviction, finding that the government did not provide sufficient evidence to support a conviction. Dr. Paulus was tried on counts of healthcare fraud and making false statements in connection with his billing for performing coronary stents, a procedure which a jury had found to be medically unnecessary given expert testimony provided at trial. The judge’s decision to set aside the jury verdict and overturn the conviction suggests that the government may face a heightened burden when trying cases of this kind. Government payors, including Medicare and Medicaid require that a treatment is medically necessary as a condition of payment for the product or service. Here, it was alleged that …

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