Matthew T. Fornataro's practice focuses on life sciences and health care regulation, and he works with a range of companies on compliance, enforcement, and legislative 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 advises pharmaceutical, biotechnology, and medical device companies on pricing and contracting matters, patient support, promotional initiatives, and government investigations. Mr. Fornataro also counsels pharmaceutical and biotechnology companies on Medicaid, Medicare Part B, Department of Veterans Affairs, and 340B Program requirements, as well as state drug price reporting laws. He has successfully litigated, on behalf of a pharmaceutical trade organization, the legality of regulations promulgated by HRSA related to the 340B program.

Mr. Fornataro advises 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, 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

  • 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.

Perspectives

HHS OIG's Proposed Rule: Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees
Advisory
Trump Administration Issues Blueprint to Lower Drug Prices and Reduce Out-Of-Pocket Costs
Advisory
Implementing Change and Continuous Improvement within the 340B Program
CBI Federal Pricing and Reporting Conference, Philadelphia, PA
Legal Town Hall: Pricing Controversy, 340B, Generics, Biosimilars and Beyond
CBI Federal Pricing and Reporting Conference, Philadelphia, PA
Master Class: Establishing a Compliant Foundation for Advocacy Programs
Q1 Productions 6th Annual Strengthening Patient Advocacy Relations Conference, Baltimore, MD
More

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
Overview

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