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Richardson Waiver Repeal: What it Means for Medtech

April 22, 2025
1:00 PM – 2:00 PM

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Beyond the Waiver: How HHS’s Shift Could Reshape Medtech’s Regulatory Landscape

An exclusive resource for AdvaMed members only.

Richardson Waiver Repeal: What it Means for Medtech

April 22, 2025
1:00 PM – 2:00 PM

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  1. Overview
  2. Pricing
  3. Speakers

Richardson Waiver Repeal: What it Means for Medtech

April 22, 2025
1:00 PM – 2:00 PM

RSVP NOW

Overview

Sorting the Potential Impact of a Key, Recent Regulatory Process Change at HHS: Repeal of the “Richardson Waiver”. 

The United States Department of Health and Human Services (HHS) made waves when it rescinded a longstanding memo – the “Richardson Waiver” – in late February. This memo voluntarily bound the Department to follow notice-and-comment procedures in the Administrative Procedure Act (APA) for certain rules, and to invoke the APA’s good-cause exception “sparingly”. This change could have significant impacts, especially on public benefit programs, and its full scope may not be known for some time. Join Sidley Austin and Health Policy Alternatives, Inc. (HPA) to learn more about the “Richardson Waiver” and what it’s repeal could mean for both medtech and the patients it serves.


Date: April 22, 2025
Time: 1:00 – 2:00 PM ET
Location: Online

Key Takeaways

  • Understand the “Richardson Waiver”: Learn what the memo was, why it mattered, and what its repeal signals about HHS’s evolving regulatory approach.
  • Explore the Impact on Rulemaking: Gain insight into how the removal of this voluntary procedural step could affect the pace and transparency of HHS regulations.
  • Analyze Compliance Implications: Discover what this shift may mean for medtech companies’ compliance obligations under the Administrative Procedure Act (APA).
  • Assess Risks and Opportunities: Hear from policy and legal experts about the potential consequences for public benefit programs and the broader health innovation ecosystem.
  • Get Practical Guidance: Walk away with actionable considerations to help your organization stay ahead of regulatory changes and protect patient access to medtech solutions.

Who Should Attend

  • 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

Pricing

FREE for AdvaMed® Members

Date: April 22, 2025 
Time: 1:00 PM – 2:00 PM ET 
Location: Online 

Check to see if your company is an AdvaMed member here. 

SIDLEY AUSTIN LLP

REBECCA WOOD is global co-leader of Sidley Austin LLP’s Food, Drug and Medical Device (FDMD) practice, serves on Sidley’s Global Life Sciences Leadership Council, and leads Sidley’s Washington, D.C. Healthcare and FDMD group.  Becky previously served as Chief Counsel (general counsel role) to the FDA under former Commissioner Scott Gottlieb, M.D.  Becky provides counsel to life sciences and medtech clients on a wide range of contentious and non-contentious FDA regulatory, compliance, and litigation issues. A significant aspect of her practice involves leading cross-disciplinary teams navigating regulatory, compliance, enforcement, and litigation matters involving FDA-regulated products.  Becky serves as an Adjunct Professor at New York University School of Law where she co-teaches a course on Food and Drug Law, Policy, and Advocacy.  Becky has been recognized by Chambers Global (USA, 2025) and Chambers USA (Nationwide, 2023–2024; District of Columbia, 2021-2024).

BRENNA JENNY is a partner in the firm’s Healthcare practice. She leverages her extensive experience in senior roles within the U.S. Department of Health and Human Services (HHS) and the Department of Justice (DOJ) Civil Division to represent clients in the healthcare industry in government enforcement actions, internal investigations, and compliance reviews. Recognized by Law360 as a “Rising Star” in Healthcare in 2021 and ranked in Chambers for her thorough, strategic, and insightful approach, Brenna stands out in her field. During the first Trump administration, she served as the Principal Deputy General Counsel at HHS and the Chief Legal Officer for the Centers for Medicare & Medicaid Services (CMS), where she supervised regulatory flexibilities during the COVID-19 pandemic and led enforcement of fraud related to the CARES Act Provider Relief Fund. Brenna has defended numerous False Claims Act investigations, achieving many declinations from federal and state governments. She also advises on fraud and abuse risk areas and has successfully reinstated Medicare and Medicaid billing privileges for providers. At both DOJ and HHS, she supervised teams defending HHS in Administrative Procedure Act challenges and has unique insights into regulatory litigation. Brenna clerked for the Honorable Raymond W. Gruender of the Eighth Circuit Court of Appeals and holds a law degree and Masters in Public Health from Harvard University.

Health Policy Alternatives, Inc.

Marc Hartstein

Marc joined HPA after 26 years with the Centers for Medicare and Medicaid Services (CMS). Marc held several management and staff positions during his time at CMS, most recently as the director of the Hospital and Ambulatory Policy Group. At CMS, Marc was central to the development of the Medicare Severity DRGs, the 2 midnight rule, Medicare policy for off-campus hospital outpatient departments, the misvalued code initiative, and regulations to implement Medicare’s new clinical laboratory fee schedule among other policies. Marc’s experience not only gives him detailed knowledge of the workings of the executive branch of government, he also has worked extensively with the legislative branch. He has assisted in the drafting of legislation, working with the Congressional Committees that have subject matter jurisdiction over Medicare. Marc has a master’s degree in public policy from the University of Minnesota’s Hubert H. Humphrey Institute of Public Affairs and a bachelor’s degree in political science and economics from the University of Vermont.

Pierre Poisson, J.D.

Pierre joined HPA in 2008 after more than 13 years providing legal and legislative drafting services with respect to U.S. health entitlement laws and other areas of federal law. In 2005, Pierre formed his own company providing policy analysis, procedural counsel, and drafting services for clients seeking assistance in developing legislation involving Medicare and Medicaid payments to providers and suppliers as well as for clients seeking improvements in health care services and other benefits under law for service members and veterans of the U.S. Armed Forces. Until 2005, he served as assistant counsel in the Office of the Legislative Counsel, U.S. House of Representatives, where for ten years he provided policy analysis and drafted legislation in the areas of Medicare, Medicaid, veterans’ benefits, and the U.S. intelligence community. He previously served as a judicial clerk for a U.S. Tax Court judge. He earned a law degree from the Dickinson School of Law and his B.A. from Middlebury College.

Jessica Shapiro, J.D.

Jessica joined HPA in 2023, after nearly 19 years of nonpartisan work with the Office of the Legislative Counsel of the U.S. House of Representatives, advising and guiding Leadership, Committee, and Member offices of the House in analyzing, drafting, and amending Federal health care legislation throughout the legislative process, from policy development of proposed legislation through introduction, Committee markup, Floor consideration, and conference. In that role, she served as the lead health counsel and drafter focusing on Medicare, Medicaid, the Children’s Health Insurance Program, private group and individual health insurance markets and reforms (including with respect to ERISA plans, IRC plan enforcement, and Public Health Service Act title XXVII enforcement), COBRA assistance, ACA Exchanges and reforms, Federal health insurance program fraud, waste, and abuse prevention, health information technology, the 340B program, and HIPAA. With respect to Medicare policy, areas included quality incentive and reporting programs, inpatient and outpatient benefits and payment systems, the Medicare Advantage program, and the prescription drug program. Jessica earned a law degree from the University of Virginia School of Law and her B.A. from the Johns Hopkins University.

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