Earlier this month, the Centers for Medicare and Medicaid (“CMS”) released a Memorandum overviewing next steps in the federal government’s implementation of the Medicare Drug Price Negotiation Program. Though CMS has only just “set the... Read More
Articles | Manufacturers | Medicare, Medicaid, and Other Commercial Payor Audits & Appeals | Pharmaceutical Manufacturers

Drug manufacturers and patients are being negatively impacted by the increasing use of insurer copay accumulator and maximizer programs. These programs prevent manufacturer assistance, such as co-pay coupons, from being applied towards a patient's... Read More
Articles | Life Sciences | Manufacturers | Pharmacy Law

On August 3, 2022, an Illinois federal jury returned a verdict ordering Eli Lilly & Co. (“Eli Lilly”) to pay $61 million for violations of the Federal False Claims Act (“FCA”) and adjacent state FCA laws. According to a qui tam lawsuit... Read More
Articles | Biotech Companies | MAC Pricing & Appeals | Manufacturers | Maximum Allowable Cost Pricing & Appeals | Pharmaceutical Manufacturers

On September 23, 2022, the Fourth Circuit issued a per curiam opinion upholding the dismissal of a 2014 qui tam suit against Forest Laboratories, LLC while vacating both the district court and subsequent Fourth Circuit panel opinions. Although the... Read More
Articles | Federal and State Fraud and Abuse Counseling | Manufacturers | Maximum Allowable Cost Pricing & Appeals | Medicare, Medicaid, and Other Commercial Payor Audits & Appeals | Pharmaceutical Manufacturers | Pharmaceutical Wholesalers | White Collar Criminal Defense & Government Investigations

America spends more on prescription drugs than any other country in the world. Although most patients have some form of insurance to help offset the costs of their prescriptions, 28% of Americans currently take a prescription medication that is not... Read More
Articles | Federal and State Fraud and Abuse Counseling | Review of Promotional and Advertising Materials | Start-Up Healthcare and Life Sciences Companies

The Ninth Circuit ruled that a pharmaceutical manufacturer cannot sue a 503B compounding facility for compounding versions of its commercially available product in Nexus Pharmaceuticals, Inc v. Central Admixture Pharmacy Services (CAPS), Nexus... Read More
Articles | Life Sciences | Outsourcing Facilities (503B) | Pharmacy Law

Pharmacy Benefit Managers (“PBMs”) regularly review network pharmacies to ensure that they are meeting terms and conditions identified in their Provider Agreements and Pharmacy Manuals. One mechanism for this review includes audits and... Read More
Antitrust Tools Available to Combat PBM Abuse of Pharmacies | Articles | Chain Pharmacies | Community, Retail Pharmacies | Defending Pharmacies in PBM Audits | Digital Pharmacies | Fertility Pharmacies | Specialty Pharmacies | Supermarket Pharmacies | Traditional Compounding Pharmacies (503A)

As previously reported, Frier Levitt filed suit against the New York Department of Health and the New York State Department of Education on behalf of an independent New York oncology practice in an effort to void the State’s new and legally... Read More
Articles | Community Oncology Practices & Other Dispensing Physician Practices | Healthcare | Healthcare Law | Life Sciences | Pharmacy Law