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»  Posts By   April 2017 

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 Impact of DIR Fees on 340B Relationships Between Contract Pharmacies and Covered Entities

The impact of Direct and Indirect Remuneration ("DIR") fees on the specialty pharmacy industry cannot be overstated and has been widely reported in White Papers and industry news reports. However, the impact of DIR fees on the 340B sector is only now being realized. In the first of a series of articles, Frier Levitt explores the basics of DIR Fees as applied to 340B. The 340B Drug Discount Program ("340B")...

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

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...