The Inflation Reduction Act (IRA) made changes to the way drugs are covered and reimbursed in Medicare. It has been anticipated that this could result in more restrictive formularies in drug plans or higher co-pays for...more
Teva Pharmaceuticals, the largest generic drug manufacturer in the United States, has agreed to pay $450 million to resolve allegations of violating the False Claims Act and Anti-Kickback Statute arising from purported...more
Although most of the recent focus around the implementation of the Inflation Reduction Act (“IRA”) by the press and industry stakeholders has been on the Medicare Drug Price Negotiation Program, the IRA has several other...more
Drug Pricing Initiatives: Discussion continues in Congress and among stakeholders of drug pricing reform measures, including those that were originally part of H.R. 5376 (the Build Back Better Act, or BBBA). ...more
On September 23, 2020, the Office of Inspector General of the United States Department of Health and Human Services (OIG) publicly released Advisory Opinion 20-05 (AO 20-05), a significant, adverse opinion rejecting a...more
Teva Pharmaceuticals USA Inc. is in the crosshairs of the U.S. Department of Justice (DOJ) on two separate matters. On August 18, the DOJ announced that it filed a lawsuit against Teva and an affiliate, Teva Neuroscience...more
Two charitable foundations that helped patients pay for drug co-payments settled anti-kickback charges for $6 million. The Patient Access Network Foundation (PANF) agreed to pay $4 million and Good Days agreed to pay $2...more
Back in May, we wrote about substantial settlements totaling $125 million to resolve Department of Justice (DOJ) allegations that money donated by Astellas Pharma US, Inc. and Amgen Inc. to drug co-pay charities constituted...more
On September 4, 2019 the Department of Justice (DOJ) announced a $15.4 million settlement with pharmaceutical company Mallinckrodt ARD LLC (Mallinckrodt) to resolve alleged violations of the Anti-Kickback Statute (AKS) in two...more
A recent settlement by retailer Kmart Corp. illustrates the breadth of practices in the healthcare space that the government considers to be illegal kickbacks that violate the False Claims Act (FCA). The U.S. Department of...more
In recent years, copayment coupon programs have become standard promotional practices for both large and small pharmaceutical manufacturers. Copayment coupons are typically offered to commercially insured patients in order...more
Brand name drugs cost a lot. So to make them more attractive, drug manufacturers issue coupons for discounts on the copayment portion of the price. They work the same as the dollar-off coupons offered by cereal manufacturers....more
For years, many drug manufacturers have issued coupons to help cover some or all of the cost of copayments (commonly referred to as a “copay”) for prescription medications. While the Department of Health and Human Services...more