CMS and OIG Issue Guidance on Implementation of the Inflation Reduction Act

The Centers for Medicare & Medicaid Services (CMS) and the US Department of Health and Human Services Office of Inspector General (OIG) continue to issue guidance regarding the implementation of the drug pricing provisions of the Inflation Reduction Act (IRA).

Most recently, the OIG issued a technical assistance brief regarding the implementation of the newly-required inflation-based rebates that manufacturers must pay for Part B drugs whose prices increase faster than inflation. Specifically, the briefing summarizes the significant administrative challenges that CMS may face in implementing the Part B rebate provisions and also identifies potential solutions to mitigate the challenges. While not formal regulations or rulemaking activity, the pharmaceutical industry should review the briefing and be on the lookout for whether CMS adopts any of the OIG’s suggestions. A copy of the briefing can be found here.

In addition, CMS continues to update its dedicated IRA website with program guidance, frequently asked questions, and timelines designed to guide the pharmaceutical industry through the significant regulatory changes occurring over the next few years. The CMS website can be found here. Further, CMS is hosting monthly stakeholder meetings with pharmaceutical manufacturers. Notices for such monthly meetings are provided via HPMS.

Participants in the pharmaceutical industry should pay close attention to the new issuances from CMS and OIG and feel free to reach out to the pharma regulatory advisors at ArentFox Schiff with questions.