Inflation Reduction Act (IRA)

Information for U.S. pharmaceutical and healthcare stakeholders

Stay up-to-date with recent developments

CMS releases draft guidance for the third cycle of Medicare Drug Price Negotiation Program

On May 12, 2025, CMS issued draft guidance that outlines the requirements for drug manufacturers participating in the negotiation process for 2028 and the effectuation of Maximum Fair Prices (MFPs) in 2026, 2027, and 2028

View guidance

HHS announces 15 additional drugs selected for the second cycle of Medicare Drug Price Negotiation Program

Medicare has selected 15 more Medicare Part D drugs to negotiate directly with participating drug companies. In accordance with the IRA, these negotiations will occur in 2025 and any negotiated prices will become effective in 2027.

View announcement

CMS releases negotiated pricing for the first cycle that will go into effect beginning January 1, 2026

To view pricing, key milestones through the first cycle of negotiations, and answers to commonly asked questions, view the CMS fact sheet linked below.

View CMS fact sheet

What you need to know about the Inflation Reduction Act

The Inflation Reduction Act (IRA), which was signed into law in August 2022, is a complex law that contains healthcare reforms, tax changes, and environmental policy provisions that impact several aspects of the U.S. healthcare ecosystem. The IRA aims to address rising healthcare costs by exploring innovative pricing models that seek to prioritize access, value, and quality.

IRA key takeaways for pharmaceutical and healthcare stakeholders

From the Medicare Drug Pricing Negotiation Program to out-of-pocket cost caps, inflation rebates, and other Medicare program changes, these are a few key takeaways for U.S. pharmaceutical and healthcare stakeholders to be aware of.

Read key takeaways

From CMS

Inflation Reduction Act and Medicare

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From Congress.gov

Read H.R.5376 - Inflation Reduction Act of 2022

View the IRA in full

Did you know?

Medicare Drug Price Negotiation Program (MDPNP) pricing goes into effect in 2026

For the first time, the IRA provides Medicare the ability to directly negotiate maximum fair pricing (MFP) of certain high expenditure, single source drugs without generic or biosimilar competition. Part D drugs are eligible for MFP beginning in 2026 while Part B drugs will be eligible in 2028.

View MDPNP overview

Visit CMS.gov

For manufacturers and impacted providers

Building a prospective solution for efficient MFP payments

Having a sustainable market-wide process to accurately and efficiently effectuate MFPs is crucial to enabling patient access to vital medications. That’s why we are building an innovative, prospective solution to assist in implementing more efficient MFP refunds by streamlining the gathering of data, calculating refunds, and transmitting data to providers and manufacturers.

Learn more

For manufacturers

Valuable insights and support to help you navigate the IRA

The Inflation Reduction Act (IRA) contains implications that pharmaceutical manufacturers need to consider across the full drug discovery, development, and commercialization spectrum. With insights on key elements and a comprehensive understanding of the IRA, our team of experts are here to help you prepare for potential impacts.

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