Matthew T. Fornataro

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.

Matt counsels on drug 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 and transparency laws. He also advises on the drug pricing and negotiation provisions of the Inflation Reduction Act of 2022. Matt assists clients with restatements, investigations, and litigation related to drug price reporting, and he drafts public comments on proposed rules and guidance.

Matt also counsels on life sciences and healthcare fraud and abuse compliance, and his counseling in this area includes addressing questions related to the federal Anti-Kickback Statute, the False Claims Act, and the Civil Monetary Penalties & Exclusion laws. 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.

Matt 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

Assist manufacturers with implementation of the drug pricing provisions of the Inflation Reduction Act of 2022, including the implications of the Medicare rebate programs and drug price negotiation.
Provide day-to-day counsel to manufacturers on drug price reporting compliance issues.
Prepare comprehensive government price reporting policies and reasonable assumptions.
Advise clients on drug pricing restatements.
Draft comments for manufacturers on the Inflation Reduction Act, the Medicaid Drug Rebate Program, and the 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).

Advise on innovative pricing and value-based purchasing arrangements, product discounting, affordability, and promotional initiatives.
Advise on various manufacturer patient support programs, including the implications of pharmacy benefit manager accumulator and maximizer programs and alternate funding programs.
Negotiate complex commercial contracts with pharmacy benefit managers, insurance companies, wholesalers, pharmacies, hospitals, and many other commercial customers.
Support product commercialization and marketing strategies.
Perform internal audits to bolster regulatory compliance, including with regard to patient support, government price reporting, managed markets contracting, and sales practices.

Prepare Office of Inspector General advisory opinion requests.
Served on secondment to the in-house legal departments of three major pharmaceutical manufacturers.
Counseled a national drug testing laboratory successfully through multiple government investigations.

Represent, along with HRC, a plaintiff in challenging the State of Florida’s ban on transgender girls’ participation in girls’ sports.
Represented the Southern African AIDS Trust in its effort to achieve favorable policies related to HIV self-testing in various African countries.
Filed and successfully resolved a lawsuit on behalf of a Virginia couple who were denied an adoption and were discriminated against based on one partner’s HIV+ status.
Represented the National Women’s Law Center to investigate Title IX compliance issues within a public school and recreation system with the goal of ensuring equal access for girls to sports facilities and fields.
Represented a rehabilitated individual sentenced to fifteen years for a non-violent offense under mandatory minimum drug laws in her pursuit of a sentence commutation by President Obama.