Matthew T. 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's practice focuses on matters governed by the Anti-Kickback Statute, and he regularly assists pharmaceutical, biotechnology, and medical device companies with complex risk analyses, internal reviews and investigations, OIG Advisory Opinion requests, and government audits and investigations. Mr. Fornataro counsels, for example, on innovative pricing and value-based contracting arrangements, product discounting, patient support, affordability, and promotional initiatives. In addition, Mr. Fornataro assists pharmaceutical and biotechnology companies with managed markets contracting, and he also regularly counsels on Medicaid, Medicare Part B, Department of Veterans Affairs, and 340B Program price reporting requirements, as well as on state drug price reporting and transparency laws.
Mr. Fornataro counsels health care providers on regulatory compliance matters, including with regard to billing and reimbursement, Medicare overpayments, internal investigations, and in responding to government enforcement actions. He has represented clients before the Department of Justice, the HHS Office of Inspector General, the Medicare Appeals Council, and related federal and state enforcement authorities.
Mr. Fornataro is Vice 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.
- 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).
- Work closely with the legal and business teams of major pharmaceutical and biotechnology companies to prepare comprehensive government price reporting policies and reasonable assumptions to ensure compliance with government price reporting obligations.
- Counsel major pharmaceutical and biotechnology companies on bundled sales arrangements, samples, patient assistance, product support services, product replacement, coupons, vouchers, and grants.
- Advise companies on drug pricing restatements and represent manufacturers in disputes with states regarding Medicaid rebate liability and state pharmacy reimbursement.
- Draft comments on Centers for Medicare and Medicaid Services and Health Resources and Services Administration proposed rules and guidance regarding drug reimbursement and government price reporting.
- JD, University of Pittsburgh School of Law, 2008
- BA, English and Philosophy, Bucknell University, 2005, magna cum laude
- District of Columbia