Richardson Waiver Repeal: Implications for the Medtech Sector
The Department of Health and Human Services (HHS) recently repealed the ‘Richardson Waiver,’ a move that could significantly affect the medical technology (medtech) industry. This shift in regulatory approach warrants careful consideration for medtech companies navigating the evolving landscape.
What the Richardson Waiver Was
The ‘Richardson Waiver’ was a memorandum that instructed HHS to follow the notice-and-comment procedures outlined in the Administrative Procedure Act (APA) for specific rules. It also encouraged the sparing use of the APA’s good-cause exception. This provided a degree of predictability and transparency in the regulatory process for medtech companies.
Potential Impacts
The repeal of the waiver could alter the speed and transparency of HHS regulations in several ways.
Key areas of impact to watch include:
- Rulemaking Pace: The removal of this voluntary procedural step might impact the swiftness with which HHS implements new regulations.
- Compliance Obligations: Medtech companies should prepare for potential changes in their compliance obligations in accordance with the APA.
- Risks & Opportunities: Policy and legal experts are assessing the potential consequences for public benefit programs and the larger health innovation ecosystem.
Key Takeaways for Medtech Professionals
Medtech professionals should be prepared to:
- Understand the significance of the ‘Richardson Waiver’ and the implications of its repeal.
- Evaluate the potential impact of this regulatory shift on their business’s compliance obligations.
- Assess any risks or opportunities that may arise from the changing regulatory environment, which will likely shift the pace of rulemaking and transparency.
This change could lead to adjustments in the regulatory processes that could impact the industry.
Event Details
This analysis is a summary of what was presented at a recent event presented by Sidley Austin and Health Policy Alternatives, Inc. (HPA).
- Date: April 22, 2025
- Time: 1:00 – 2:00 PM ET
- Location: Online
Who Should Be Paying Attention
- In-house legal counsel and compliance officers in the MedTech industry
- In-house Payment, Coverage, and Reimbursement executives and personnel
- Executives and decision-makers in medical technology companies
