Overview
Reforming prescription drug prices in the Medicare program has been a focal point of the Inflation Reduction Act of 2022 (IRA). 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.
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- BlogsCMS Rules Propose Changes Regarding the Medicare Prescription Drug Inflation Rebate Program, Refundable Drugs, Skin ...13 minute read
- PublicationsThe IRA: Reducing Inflation or Threatening Patient Access?2 minute read
- PublicationsCMS Seeks Stakeholder Feedback About Medicare Transaction Facilitator Services for the Medicare Drug Price Negotiation ...4 minute read
- Media CoverageRichard Hughes, Will Walters Quoted in “SCOTUS Cases Could Create ‘Fractured’ Health Care Policy Landscape” ...2 minute read
- Media CoverageRachel Snyder Good Featured in “The Top Mid-Law People Moves of 2023 So Far”2 minute read
- PublicationsCMS Releases Its List of 43 Part B Rebatable Drugs for Q3: Inflation Reduction Act Updates7 minute read
- PublicationsManufacturers Must Request Small Biotech Exception by July 3: Inflation Reduction Act Updates4 minute read
- PublicationsCMS Seeks Comment on Initial Guidance for the Part D Manufacturer Discount Program: Inflation Reduction Act Updates ...2 minute read
- BlogsPodcast: Inflation Reduction Act’s Drug Price Negotiation Provisions – What’s Next? - Diagnosing Health Care3 minute read
- PublicationsCMS Issues an Information Collection Request for the Drug Price Negotiation Process: Inflation Reduction Act Updates ...3 minute read
- PublicationsIs CMS Ignoring the Realities of Biopharmaceutical Costs?2 minute read
- PublicationsCMS’s Initial Guidance on Medicare Drug Price Negotiation Program Suggests Familiar Pharmacy Chargeback Process ...12 minute read
- PublicationsCMS Issues an Information Collection Request on Negotiation Data Elements: Inflation Reduction Act Updates3 minute read
- BlogsIs CMS Ignoring the Realities of Biopharmaceutical Costs?6 minute read
- PublicationsCMS Issues New Guidance on Medicare Drug Price Negotiation Program: Inflation Reduction Act Updates2 minute read
- PublicationsCMS Releases Its List of 27 Part B Rebatable Drugs for Q2 of 2023: Inflation Reduction Act Updates3 minute read
- BlogsComments to CMS Guidance on the Medicare Prescription Drug Inflation Rebate Program Due March 11, 202310 minute read
- PublicationsCMS Launches First Federal Regulatory Action to Implement Medicare Drug Price Negotiation Program6 minute read