Matthew T. Fornataro's practice focuses on healthcare regulatory compliance and litigation, and he works with a variety of healthcare entities including pharmaceutical, biotechnology, and medical device manufacturers, as well as related trade societies. Mr. Fornataro also counsels physician practices, clinical laboratories, ambulatory facilities, and other healthcare providers.

Mr. Fornataro regularly advises pharmaceutical, biotechnology, and medical device companies on pricing and contracting matters, patient support, promotional initiatives, and government investigations, and his work focuses principally on matters governed by the False Claims Act and the Anti-Kickback Statute. Mr. Fornataro has extensive experience in advising pharmaceutical and biotechnology companies on their drug price reporting obligations under the Medicaid, Medicare Part B, 340B, and VA programs. 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 healthcare providers on regulatory compliance matters, including with regard to billing and reimbursement, Medicare overpayments, corporate structuring, 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.

In 2014, Mr. Fornataro was selected by the National LGBT Bar Association as one of its "Best LGBT Lawyers Under 40" based on his professional accomplishments and the significant pro bono contributions he has made to causes of importance to the LGBT 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

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
The Shifting Landscape of the 340B Program: Key Areas for Manufacturer Attention
Arnold & Porter Kaye Scholer Webinar
Defining Value: Risk Sharing, Outcome Contracts & Financial Forecasting
Q1 Productions 10th Semi-Annual Life Science CFO Strategic Governance Forum
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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