Matt Wetzel

Matt Wetzel provides strategic counseling to life sciences companies on a host of complex health laws and regulations, including federal and state fraud and abuse laws, Medicare and other reimbursement requirements, patient privacy obligations, and transparency requirements, among other areas.

Matt brings a unique, 360-degree perspective of the legal and compliance issues affecting life sciences companies. As a veteran of the life sciences industry, he has a pragmatic approach to counseling his clients. Prior to joining Goodwin, Matt served as Chief Compliance Officer of a Silicon Valley diagnostic start-up; was the Vice President & Deputy General Counsel of the world’s largest medical technology trade association in Washington, DC; and he held an executive legal and compliance role at a multinational medical device maker.

Matt co-leads the firm’s Medtech practice and co-chairs the firm’s Late Stage Drug Development practice.

Matt counsels medical technology manufacturers, pharmaceutical and biologics companies, laboratory testing and diagnostic companies, and a variety of other health care and life sciences organizations.

Matt’s practice includes working with life sciences companies to address issues under the Federal Anti-Kickback Statute and state equivalents, the Stark Law, the Beneficiary Inducement Law, the False Claims Act, the Sunshine Act, and other laws. Matt counsels life sciences companies on Medicare and Medicaid coverage and billing requirements, including working with pharmaceutical, medtech, and diagnostic companies on their market access and coverage concerns. Matt serves as the firm’s expert on the Inflation Reduction Act.

Leveraging his extensive in-house experience in both the multinational setting and the start-up environment, Matt supports life sciences companies in the following ways:

• Leading and conducting significant internal investigations into allegations of wrongdoing raised through corporate compliance programs, from building investigations plans, conducting interviews and document reviews, to developing final recommendations and close-out requirements
• Serving as an independent compliance expert for boards, c-suites, and investors in life sciences companies, including conducting independent third-party compliance program risk assessments and third-party audits of life sciences companies’ sales and marketing activities, billing and reimbursement programs, and customers relationships
• Counseling clients on building effective global compliance and risk management programs, including compliance strategy development and crafting policies and training materials
• Structuring financial and remunerative relationships with customers and other health care providers, including strategic counseling on sales and marketing practices, innovative value-based arrangements, and discounting and pricing practices

Matt’s unique experience also gives clients deep benchmarking insight and a comprehensive view of industry best practices in a variety of areas. As Vice President & Deputy General Counsel at AdvaMed, Matt spearheaded many of the medical technology’s legal policy initiatives in Washington, DC as well as supported the industry’s compliance efforts.

Matt also represents life sciences and health care clients before key federal and state policymakers, including Congress, the Centers for Medicare and Medicaid Services, and the US Department of Health & Human Services Office of the Inspector General.

Matt is the featured Medtech & Life Sciences expert contributor to the Washington Legal Foundation where he writes about life sciences, medtech regulation, pharmaceutical issues, healthcare law, and government regulation. He also hosts a regular podcast on health care fraud for the American Health Law Association and serves on the Editorial Board of the Policy & Medicine Compliance Update, a monthly periodical for life sciences lawyers on current enforcement and regulatory issues.

Prior to joining Goodwin, Matt held several executive positions in the life sciences industry.

• Associate General Counsel & Chief Compliance Officer of GRAIL, Inc.
• Vice President & Deputy General Counsel, AdvaMed
• Senior Counsel, Global Compliance & Ethics, Boston Scientific

Matt serves on the Board of Directors of the American Health Law Association (AHLA).  Matt was the 2023 Recipient of the Patricia J. Meador Fraud & Abuse award from AHLA for his service in advancing healthcare fraud & abuse education.

Matt also serves on the Board of Directors of the World War II Foundation, a non-profit organization that produces award-winning documentaries about World War II for public television. 

Some of Matt’s notable recent publications and presentations include:

• Speaker, “The Inflation Reduction Act: An In-Depth Review of Changes to Medicare Pricing under the IRA,”  ACI Drug Pricing Bootcamp, November 13, 2023
• Speaker, “Compliance & Market Access: Top Considerations for Compliance Officers,” 24th Annual Pharmaceutical and Medical Device Congress, October 25, 2023
• Speaker, “The IRA’s Drug Price Program: What You Need to Know as the “Negotiation” and Litigation Heat Up,” Washington Legal Foundation Webinar (featuring former FDA Chief Counsels Stacy Cline Amin and Dan Troy), October 16, 2023
• Author, “Federal Court Strikes Down Copay Accumulator Programs,” Washington Legal Foundation Legal Pulse, October 12, 2023
• Speaker, “Chief Compliance Officer Lightning Round: Top Developments for Medtech Business Leaders in 2023,” The MedTech Conference, October 11, 2023
• Speaker, “The MedTech Startup Equation,” The MedTech Conference, October 11, 2023
• Author, “Initial Lawsuits Claim IRA’s Compelled Drug-Price Negotiation is Broad Break with Rule of Law,” Washington Legal Foundation Legal Pulse, June 22, 2023
• Speaker, “Commercialization in the Post-COVID Era,” MPM BioImpact 19th Annual Healthcare Leaders’ Summit, May 24, 2023
• Author, “Medicare’s Initial Plans for the Medicare Drug Price Negotiation Program,” Washington Legal Foundation Legal Pulse, January 16, 2023
• Author, “Mandated Rebates and “Negotiation”: The IRA Paves a Rocky Road for Pharma and Biotech Innovation,” Washington Legal Foundation Legal Backgrounder, November 18, 2022
• Co-Author, “Top 5 Compliance Issues for Medtech Firms Transitioning To Data-Enabled Solutions,” MedCity News, January 27, 2023
• Co-Author, “Top 5 FDA Considerations for Medtech-Enabled Data Platforms,” MedCity News, January 24, 2023
• Co-Author, “Top 5 IP Considerations for Medtech Companies Transitioning To Data-enabled Product Solutions,” MedCity News, January 20, 2023
• Co-Author, “4 Key Issues Driving Drug Discount Abuse Must Be Addressed,” Law 360, January 1, 2023
• Author, “New OIG Advisory Opinion Impacts Pharmaceutical & Medical Device Company Funding of Continuing Education Programs,” Washington Legal Foundation, June 30, 2022
• Co-Author, “HHS Opines on Longstanding Diagnostic Testing Issue,” Washington Legal Foundation, May 17, 2022
• Author, “Device Industry Ethics Code Evolves As Care Approach, Government Scrutiny, Change,” Washington Legal Foundation, April 25, 2022
• Speaker, “Recent Developments Related to Electronic Health Records,” American Health Law Association Fraud & Abuse Podcast, April 19, 2022
• Speaker, “Risks Associated with HRSA-Paid COVID Claims,” American Health Law Association Fraud & Abuse Podcast, March 21, 2022
• Speaker, “2022 Predictions,: American Health Law Association Fraud & Abuse Podcast, February 8, 2022
• Speaker, “Latest Stark Law Developments,” American Health Law Association Fraud & Abuse Podcast, January 11, 2022
• Speaker, “340B Program Issues,” American Health Law Association Fraud & Abuse Podcast, December 31, 2021
• Speaker, “Assessing 2021 Health Law Enforcement Trends,” American Health Law Association Fraud & Abuse Podcast, December 21, 2021
• Speaker, “A Look at OIG’s Push for Modernized Guidance,” American Health Law Association Fraud & Abuse Podcast, October 19, 2021
• Speaker, “Demystifying Monitorships – What General Counsel & Compliance Officers Need to Know,” American Health Law Association Fraud & Abuse Podcast, September 21, 2021
• Co-Author, “Probing HHS for Consistency on the 340B Pricing-Program Rules on Contract Pharmacies,” Washington Legal Foundation, September 13, 2021
• Speaker, “Health IT Fraud & Enforcement,” American Health Law Association Educational Call, August 5, 2021
• Speaker, “Best Practices Related to PAPs, Copays, and Foundations,” Informa Connect Compliance Congress for Specialty Products, June 23, 2021
• Speaker, “Forecasting Compliance Priorities for 2021 and Beyond: Pre-Commercial Life Sciences Companies,” (Benchmarking Session), Informa Connect Compliance Congress for Specialty Products, June 22, 2021
• Speaker, “Patient Support Services — Field Sales Compliance,” Informa Connect Patient Support Services Compliance Congress, June 16, 2021
• Speaker, “DOJ’s Telemedicine Fraud Takedown – What Providers Need to Know,” American Health Law Association Fraud & Abuse Podcast, May 18, 2021
• Speaker, “Agency Interactions — The Advisory Opinion Process,” American Health Law Association Fraud & Abuse Podcast, April 13, 2021
• Speaker, “Congressional Oversight & Investigations in Fraud & Abuse,” American Health Law Association Fraud & Abuse Podcast, March 16, 2021
• Speaker, “How Corporate Governance Can Affect Corporate Culture,” American Health Law Association Fraud & Abuse Podcast, February 22, 2021
• Speaker, Fraud & Abuse: 2020 in Review and a Look Ahead to 2021,” American Health Law Association Fraud & Abuse Podcast, January 25, 2021
• Speaker, “Compliance Tips for Integrated Health Care Organizations,” American Health Law Association Fraud & Abuse Podcast, December 28, 2020
• Speaker, “What Health Lawyers Need to Know about the Final Stark and Anti-Kickback Value-Based Rules,” American Health Law Association Fraud & Abuse Podcast, December 14, 2020
• Speaker, “Proposed Changes to Physician Compensation,” American Health Law Association Fraud & Abuse Podcast, November 23, 2020
• Speaker, “AI & Machine Learning: How Can Innovative Technology Help in the Fight Against Health Care Fraud & Abuse?,” American Health Law Association Fraud & Abuse Podcast, November 2, 2020
• Speaker, “False Claims Enforcement Against EHR Developers,” American Health Law Association Fraud & Abuse Podcast, July 20, 2020
• Speaker, “Government Enforcement in Lab Testing,” American Health Law Association Fraud & Abuse Podcast, May 18, 2020
• Keynote Speaker, “Promoting Ethics, Integrity, and Compliance in the US Medical Technology Industry — The Transformative Power of Values-Based Compliance,” South African Medical Technology Industry Association Annual Conference, Midrand, South Africa, July 2019
• Speaker, “How to Successfully Interface with Vendors,” American Association of Physicists in Medicine Annual Meeting, San Antonio, Texas, July 2019
• Speaker, “AdvaMed Code of Ethics Update,” CBI MedTech Compliance Congress, Chicago, June 2019
• Speaker, “Global Transparency Reporting Update,” CBI Global Transparency Reporting Conference, Philadelphia, May 2019
• Speaker, “Values-Based Compliance,” Medmarc Annual Brokers Meeting, Las Vegas, February 2019