Matt Fornataro advises life sciences companies on complex health care regulatory, litigation, and public policy matters. Based in Boston, his practice focuses on drug pricing and government price reporting, pharmaceutical market access and contracting, and fraud and abuse compliance. Drawing on the depth of Arnold & Porter’s nationally recognized life sciences practice and Washington, D.C. presence, Matt works with established and emerging pharmaceutical, biotechnology, and medical device manufacturers.
Matt counsels clients on evolving drug pricing and reimbursement issues, including Most-Favored-Nation (MFN) initiatives and the Medicare Drug Price Negotiation Program and its Maximum Fair Price requirements. He also advises manufacturers on fraud and abuse compliance and contracting across the pharmaceutical supply chain and coverage landscape. His work includes complex risk analyses, internal reviews and investigations, HHS Office of Inspector General (OIG) Advisory Opinion requests, product acquisitions and divestitures, government audits and investigations, and Congressional inquiries.
Matt is co-chair of Arnold & Porter’s Pride Affinity Group and serves on the firm’s Diversity and Inclusion Committee and Professional Development Committee. In 2014, the National LGBTQ+ Bar Association named him one of its “Best LGBTQ+ Lawyers Under 40,” recognizing his professional accomplishments and pro bono work on matters important to the LGBTQ+ community.
Experience
- Advise drug and biologics manufacturers in negotiating Most-Favored-Nation (MFN) drug pricing agreements with the Trump Administration, including related tariff agreements with the U.S. Department of Commerce.
- Advise manufacturers on government price reporting methodologies and reasonable assumptions, including positions developed for Trump Administration MFN agreements and GENEROUS participation agreements.
- Advise pharmaceutical and biotechnology manufacturers on implementation of the Medicare Drug Price Negotiation Program established by the Inflation Reduction Act, including CMS setting of Maximum Fair Price (MFP), information collection requests, and implementation and effectuation requirements.
- Provide ongoing counsel on government price reporting and drug pricing compliance, including the Medicaid Drug Rebate Program (MDRP), Medicare Part B Average Sales Price (ASP), the 340B Drug Discount Program, and Department of Veterans Affairs/Federal Supply Schedule (VA/FSS) requirements.
- Develop comprehensive government price reporting policies and reasonable assumptions and advise manufacturers on drug pricing restatements, agency disclosures, and related compliance matters.
- Advise pharmaceutical manufacturers on the 340B Drug Discount Program, including manufacturer pricing and compliance obligations, contract pharmacy arrangements, and implementation of HRSA’s 340B Rebate Model Pilot Program.
- Draft comments on proposed rules and agency guidance involving pharmaceutical drug pricing and reimbursement, including the Medicare Drug Price Negotiation Program, MFN pricing models, the Medicaid Drug Rebate Program, and the 340B Drug Discount Program.
- Develop and lead business-focused training on government price reporting compliance, including discounting, bundled sales, Medicaid Best Price stacking, patient support arrangements, and value-based purchasing arrangements.
- Represented the Pharmaceutical Research and Manufacturers of America (PhRMA) in successful challenges to the legality of the Health Resources and Services Administration’s (HRSA) Orphan Drug Exclusion Final Rule and subsequent interpretive rule.
Perspectives
Recognition
Credentials
Education
- J.D., University of Pittsburgh School of Law, 2008
- B.A., English and Philosophy, Bucknell University, 2005, magna cum laude
Admissions
- District of Columbia
- Massachusetts
- Pennsylvania