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

A New York-based pharmacy client was facing an audit conducted by a major pharmacy benefit manager (“PBM”). During the audit, the PBM conducted an invoice reconciliation, causing it to assert thousands of unsubstantiated claims. In fact, the PBM... Read More
Articles | Chain Pharmacies | Community, Retail Pharmacies | Defending Pharmacies in PBM Audits | Digital Pharmacies | Fertility Pharmacies | Integrated Delivery Network and Hospital System Pharmacy | Long-Term Care Pharmacies | News | Recent Results | Recent Successes | Specialty Pharmacies | Supermarket Pharmacies | Traditional Compounding Pharmacies (503A)

As the Pharmacy Benefit Managers (PBMs) prepare for the end-of-year “housekeeping”, pharmacies should be aware of the PBM audit trends and arm themselves with information necessary to preempt—and strategies to outright avoid—falling victim... Read More
Antitrust Review and Compliance | Antitrust Tools Available to Combat PBM Abuse of Pharmacies | Articles | Biotech Companies | Chain Pharmacies | Community, Retail Pharmacies | Defending Pharmacies in PBM Audits | Digital Pharmacies | Fertility Pharmacies | Integrated Delivery Network and Hospital System Pharmacy | Long-Term Care Pharmacies | Specialty Pharmacies | Supermarket Pharmacies | Traditional Compounding Pharmacies (503A) | Uncategorized

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