Matt Wetzel is an experienced health lawyer and provides strategic advice to life sciences companies on complex health care laws and regulations, including federal and state fraud and abuse laws, Medicare and third party billing and reimbursement regulations, patient privacy obligations, and transparency requirements, among other areas. Matt also works with clients to establish and operate effective global compliance and risk management programs.
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 brings 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 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 analyzes complex business arrangements 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. He helps structure 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 also works with pharmaceutical and biologics manufacturers on a host of issues relating to market access, including advising on payor and PBM contracting and counseling clients on compliance with government pricing programs, such as the Medical Drug Rebate Program.
Leveraging his extensive in-house experience in both the multinational setting and the start-up environment, Matt works with clients to develop and implement effective compliance programs. This includes drafting policies and internal control documents; training employees and agents on appropriate customer interactions; conducting risk assessments and audits to help identify potential vulnerabilities or gaps; conducting internal investigations in response to allegations of wrongdoing; and offering strategic guidance on the evolution and growth of life sciences companies’ compliance programs.
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.
Below are links to his recent Washington Legal Foundation articles:
- New OIG Advisory Opinion Impacts Pharmaceutical & Medical Device Company Funding of Continuing Education Programs
- HHS OIG Opines on Longstanding Medtech Legal Issue — Physician-Owned Device Distributors
- HHS Opines on Longstanding Diagnostic Testing Issue
- Device Industry Ethics Code Evolves as Care Approach Government Scrutiny, Change
- District Court Finds Favorably For Manufacturers in 340B Contract Pharmacy Dispute
- HRSA Takes Additional Measures to Enforce Unclear, Inconsistent 340b Contract Pharmacy Requirements
- Probing HHS for Consistency on the 340B Pricing-Program Rules on Contract Pharmacies
- Is it Time for Clearer Rules on Patient Assistance?
Matt's recent experience includes representation of:
- Conducts internal investigations on behalf of pharmaceutical companies in connection with internal compliance matters
- Advises pharmaceutical and biologics companies on compliance with drug pricing and reporting obligations, including the provisions of the Inflation Reduction Act of 2022, the Medicaid Drug Rebate Program and other related government pricing programs
- Represents medical device trade association in connection with code of ethics and compliance benchmarking
- Represents multiple global medical device manufacturers in connection with the development and execution of global compliance programs, including preparing compliance policies and advising on internal controls and systems
- Counsels multiple advanced laboratory testing companies on all manner of compliance, coverage and reimbursement, fraud and abuse, health care regulatory and government affairs-related matters
- Advises genetic testing companies on coverage, reimbursement, and compliance issues, including addressing payor disputes
- Advises multiple late-stage drug companies on matters related to commercial launch, including drug pricing, payor contracting, compliance program set-up, transparency requirements, and patient assistance and support programs
- Counsels nationwide chain of physician practice groups on health care regulatory and compliance matters
- Counsels nationwide chain of fertility and reproductive clinics on health care regulatory and compliance matters
- Advises women’s health and digital health technology companies on legal and regulatory implications of commercial models
- Counsels home medical equipment and infusion company on compliance with Medicare & Medicaid requirements
- Represents independent sales organizations in connection with the negotiation of service agreements with large pharmaceutical companies.
- Counsels direct-to-consumer laboratory testing start-up on corporate and regulatory requirements associated with its business model
- Represents telehealth-based therapy company on compliance, corporate, and regulatory requirements in connection with launch
- Provides compliance counseling to early-stage pharmaceutical companies in connection with clinical research arrangements and interactions with healthcare providers
- Pinnacle Fertility in its acquisition of MWM Medical d/b/a Center for Reproductive Care, a premier fertility medical practice that offers a wide spectrum of fertility treatments including In Vitro Fertilization (IVF), egg and sperm donation, gestational surrogacy and reproductive surgery
- CathWords Ltd., an Israeli medical device company, in connection with an investment and strategic partnership agreement with Medtronic.
- Behrman Capital, in connection with the sale of its portfolio company Emmes, a global full-service clinical research organization, to New Mountain Capital
- PepGen Inc., a clinical-stage biotechnology company addressing the treatment of severe neuromuscular and neurological diseases, in its initial public offering of shares of common stock
- CPS Solutions, LLC, a Frazier Healthcare portfolio company and one of the nation’s largest pharmacy and hospital services providers, in its $780 million acquisition of Trellis Rx, LLC, a technology-enabled specialty pharmacy service provider
- Senti Biosciences, Inc. in its business combination with Dynamics Special Purpose Corp., a special purpose acquisition company
- The purchaser in connection with Cutera, Inc.’s $230,000,000 offering of % convertible notes. Cutera is a leading provider of aesthetic and dermatology solutions for medical practitioners worldwide
- Symeres, one of the largest European small molecule CRO & CDMOs, in its acquisition of Organix, a specialized organic chemistry services provider.
- Clarus Therapeutics, a pharmaceutical company with expertise in developing androgen and metabolic therapies for men and women, in its public offering of shares of common stock
- Altasciences in its acquisition of Valley Biosystems, a non-human primate (NHP) contract research organization operating within the pre-clinical drug development space, enabling NHP research and development
- B Capital Group in its Series B Preferred Stock financing of Carlsmed, a developer of a spinal implant device and medical system designed to improve outcomes and decrease the cost of healthcare for spine surgery
- Novo in its acquisition of Ritedose, the U.S. market leader in the development and manufacturing of sterile blow-fill-seal and unit-dose pharmaceutical products, from Humanwell and AGIC
- Biocon Biologics, a biopharmaceutical company that develops affordable biosimilars, novel biologics & complex APIs, in its agreement with Viatris, a provider of access to medicines, advances sustainable operations, develops innovative solutions and leverages their collective expertise to improve patient health
- Emmes, a global, full-service Clinical Research Organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, in its acquisition of Casimir, a U.S.-based CRO
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 began his career as an associate at two global law firms, advising health care and life sciences companies on a variety of health care fraud and abuse, billing and reimbursement, and transparency-related matters.
Matt serves as chair of the AdvaMed PRIDE Leadership Network, the medical technology industry’s diversity initiative designed to raise the profile and visibility of out-and-open senior executives in medtech. In addition, he has also held several leadership positions with the American Health Law Association (AHLA), since 2019 serving as chair of the AHLA’s Fraud & Abuse Practice group, the association’s largest specialty group.
A trained executive and career coach, Matt also serves on the Board of Directors for the World War II Foundation, a nonprofit organization that produces award-winning documentary films about World War II.
- District of Columbia
Some of Matt’s notable recent publications and presentations include:
- 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