Matt Fornataro's practice focuses on life sciences and health care regulation, litigation, and public policy matters. Based in Boston, Matt specializes in drug pricing and government price reporting, pharmaceutical market access strategies and contracting, and fraud and abuse compliance. His practice draws on the depth of Arnold & Porter’s nationally recognized life sciences practice and Washington D.C. presence, and he works with established and emerging pharmaceutical, biotechnology, and medical device manufacturers.
Matt supports his clients on cutting-edge drug pricing matters, including recent Most Favored Nation initiatives and the Medicare Maximum Fair Price program. Alongside this work, Matt advises manufacturers on fraud and abuse compliance and customer contracting across the pharmaceutical supply chain and coverage landscape. Matt assists manufacturers with complex risk analyses, internal reviews and investigations, OIG Advisory Opinion requests, product acquisitions and divestitures, government audits and investigations, and Congressional inquiries.
He is co-chair of Arnold & Porter's Pride Affinity Group and was named by the National LGBTQ+ Bar Association in 2014 as one of its "Best LGBTQ+ Lawyers Under 40" for his professional accomplishments and pro bono work for causes of importance to the LGBTQ+ community. Matt also serves as a member of the Firm’s Diversity and Inclusion Committee and Professional Development Committee.
Experience
- Supported several drug and biologics manufacturers with negotiation of "most favored nations" drug pricing agreements with the Trump Administration (including related Commerce Department agreements).
- Assist manufacturers with development of reasonable assumptions and methodology positions for participation in MFN reporting programs, including under Trump Administration MFN agreements and GENEROUS participation agreements.
- Assist manufacturers with implementation of the drug pricing provisions of the Inflation Reduction Act of 2022, including support for price setting meetings with CMS and responding to information collection requests.
- Provide day-to-day counsel to manufacturers on drug price reporting compliance, including for the Medicaid Drug Rebate Program, Part B Average Sales Price reporting, the 340B Program, and the VA/FSS reporting program.
- Prepare comprehensive government price reporting policies and reasonable assumptions and support manufacturers with drug pricing restatements and agency disclosures.
- Draft comments for manufacturers on proposed rules and guidance related to the Inflation Reduction Act's drug pricing provisions, MFN pricing models, the Medicaid Drug Rebate Program, and the 340B Program (including effectuation of HRSA's rebate model pilot program).
- Coordinate business-focused trainings on government price reporting compliance issues, including discounting, bundled sales, Best Price stacking, patient support arrangements, and value-based purchasing arrangements.
- Advise on pending legislation, regulatory reforms, and Congressional investigations.
- Represented the Pharmaceutical Research and Manufacturers of America (PhRMA) in two successful challenges to the legality of the Health Resources and Services Administration’s 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