Matt Fornataro's practice focuses on life sciences and health care regulation, and he works with a range of companies on compliance, enforcement, contracting, and public policy matters. His clients include established pharmaceutical, biotechnology, and medical device manufacturers, as well as related trade societies, and he also counsels clients with emerging products and therapies.

Mr. Fornataro counsels on pricing and government price reporting compliance issues, and he regularly advises manufacturers on Medicaid, Medicare Part B, Department of Veterans Affairs, and 340B Program requirements, as well as state drug price reporting laws. Mr. Fornataro assists clients with restatements, investigations, and litigation related to drug price reporting, and he drafts public comments on proposed rules and guidance.

Mr. Fornataro also counsels on life sciences and healthcare fraud and abuse issues, including particularly matters governed by the federal Anti-Kickback Statute. He assists pharmaceutical, biotechnology, and medical device manufacturers with complex risk analyses, internal reviews and investigations, OIG Advisory Opinion requests, and government audits and investigations.

Mr. Fornataro is Co-Chair of Arnold & Porter's Pride Affinity Group for LGBTQ+ attorneys, and he was selected by the National LGBT Bar Association as one of its 2014 "Best LGBT Lawyers Under 40" for his professional accomplishments and pro bono work for causes of importance to the LGBTQ+ community.

Experience

  • Provide day-to-day counsel to manufacturers on drug price reporting compliance issues.
  • Prepare comprehensive government price reporting policies and reasonable assumptions.
  • Advise companies on drug pricing restatements.
  • Draft comments on Medicaid and 340B Program proposed rules and guidance.
  • Coordinate business-focused trainings on government price reporting compliance issues, including discounting, bundled sales, Best Price stacking, 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. See Pharmaceutical Research and Manufacturers of America v. U.S. Dep’t of Health and Human Servs., et al., 13-cv-1501 (D.D.C. May 23, 2014) and Pharmaceutical Research and Manufacturers of America v. U.S. Dep’t of Health and Human Servs., et al., 14-cv-1685 (D.D.C. October 14, 2015).

Recognition

National LGBT Bar Association
"40 Best LGBT Lawyers Under 40" (2014)

Credentials

Education
  • JD, University of Pittsburgh School of Law, 2008
  • BA, English and Philosophy, Bucknell University, 2005, magna cum laude
Admissions
  • District of Columbia
  • Pennsylvania
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