Reforming prescription drug prices in the Medicare program is a focal point of the Inflation Reduction Act of 2022 (IRA), signed into law on August 16, 2022.
The IRA’s prescription drug pricing provisions include sweeping changes that will impact stakeholders across the health care and life sciences industry.
Among other changes, the IRA’s key prescription drug pricing provisions establish the Medicare Drug Price Negotiation Program and the Medicare Prescription Drug Inflation Rebate Program and redesign the Medicare Part D benefit. Manufacturers that fail to comply with applicable IRA provisions could be subject to costly enforcement action.
The IRA’s prescription drug pricing provisions will have long-lasting implications for pharmaceutical and biological innovations, and clients look to Epstein Becker Green’s IRA team to guide them through the implementation of those provisions and to understand future implications.
How We Help
Epstein Becker Green’s IRA team leverages years of experience to provide comprehensive counsel and strategies to advise all players in the drug distribution and payment chain continuum, including drug developers, researchers, biotechnology and pharmaceutical manufacturers, distributors, insurers, pharmacy benefit managers, and pharmacies.
Our IRA team assists our clients in addressing and complying with the operational, compliance, and legal issues that are expected to emerge from the IRA’s prescription drug pricing provisions over their multi-year implementation period. We also provide strategic analysis to advise on research and development activities, new product indications, the product approval pathway, launch timing and pricing considerations, operational processes, and building infrastructure for compliance. Our deep knowledge in this area stems from advising clients on the spectrum of drug price reporting requirements and compliance obligations, including under Medicare, Medicaid, the 340B Drug Discount program, and other programs.
In the coming months and years, the U.S. Department of Health and Human Services and the Centers for Medicare & Medicaid Services are expected to issue proposed rules and guidance documents relating to the IRA’s prescription drug pricing provisions. Our IRA team closely tracks and analyzes new developments in this area to keep clients informed of all critical legal and regulatory updates and to help clients strategically respond to opportunities for comment.