Professionals

T. Reed Stephens

Partner

Co-Chair, Health Care and Life Sciences Industry Group

Overview
Experience
Credentials
Insights & News

Reed is a nationally recognized legal authority in the life sciences industry, as well as the pharmaceutical fraud and abuse and corporate compliance spaces, and focuses his practice on fraud and abuse defense, corporate compliance, and risk management across the full spectrum of healthcare providers, managed care organizations, pharmaceutical manufacturers and medical device companies. He has extensive experience with the Anti-Kickback Statute and Stark Physician Self-Referral Law, and False Claims Act litigation.

Reed represents pharmaceutical and biotech manufacturers, wholesalers and individuals, health care systems, and non-health care-related companies in various global industries. This includes the defense industry, government contractors in the gaming industry, as well as the financial services and banking sectors. He has experience in matters involving state and federal government law enforcement and U.S. congressional investigations. He represents health systems and managed care organizations in federal False Claims Act litigation, and counsels pharmaceutical manufacturers on government drug pricing and voluntary disclosures in the areas of Medicaid Drug Rebate, Federal Supply Schedule/Department of Veterans Affairs, and the 340B program.

Furthermore, Reed advises his clients—including private equity sponsors—and provides employee training on risk management concerns involving mergers and acquisitions, post-merger integration compliance and disclosure of misconduct, public policy and legislative developments, supply chain disputes, and an array of regulatory compliance matters concerning product marketing and foreign anti-corruption statutes. He is a member of the firm’s Videogame, Gaming and Esports Industry Group dedicated to providing comprehensive legal solutions to companies in this industry.

Previously, Reed was a Trial Attorney with the Civil Frauds Section within the U.S. Department of Justice Civil Division, where he led more than 60 federal False Claims Act investigations—the majority involving allegations of health care fraud perpetrated against various government agencies. Reed was lead counsel for the U.S. in the first successful government price reporting cases against the pharmaceutical industry, involving Medicare and Medicaid Average Wholesale Price reporting (US ex rel. Ven-A-Care v. et al.); Medicaid Drug Rebate price reporting (US ex rel. Foster v. Parke-Davis, US ex rel. Alcorn v. Schering-Plough); and the Prescription Drug Marketing Act fraud (US ex rel. Gerstein v. TAP Pharmaceuticals).

Key Matters

Some of the experience represented below may have been handled at a previous firm.

United States ex rel. Kunz v. Halifax Health, et al. – Obtained summary judgment for defendants on non-intervened False Claims Act allegations involving more than US$450M in alleged damages for Anti-Kickback Statute, Stark law and Medicare lack of medical necessity violations
United States ex rel. Bates and Patrick v. Kyphon, Inc.– Represented several health systems in the long-running Medicare short stay Kyphoplasty medical necessity False Claims Act qui tam
United States ex rel. Cortinas v. Midtown Imaging, LLC, et al. – Obtained favorable mediated resolution of False Claims Act Anti-Kickback allegations
Advised senior management and the board of directors of a global manufacturer in connection with whistleblower allegations of employee misconduct
Represented a major pharmaceutical manufacturer in a joint U.S. Senate and U.S House of Representatives congressional investigation of pharmaceutical product price increases
Represented several employees of a pharmaceutical manufacturer during federal grand jury proceedings in an Off Label Promotion civil/criminal investigation
Represented department head of an academic medical center during a federal criminal investigation of Anti-Kickback allegations against medical device company Olympus
Obtained declination and dismissal with prejudice of False Claims Act allegations of Medicare false billing assert against a national rehabilitation hospital chain
Represented a global U.S. defense contractor in connection with a voluntary disclosure to the U.S. Department of Defense of contract billing compliance concerns
Assisted a pharmaceutical manufacturer in achieving compliance with court-ordered remedial steps involving enhancements to corporate by-laws and regulatory affairs responsibilities triggered by a shareholder derivative case
Represented U.S. subsidiary of a global gaming company in connection with District of Columbia Office of Attorney General investigation of government contract compliance

Capabilities

Government Program Fraud, False Claims Act & Qui Tam Litigation

Key Matters

Some of the experience represented below may have been handled at a previous firm.

United States ex rel. Kunz v. Halifax Health, et al. – Obtained summary judgment for defendants on non-intervened False Claims Act allegations involving more than US$450M in alleged damages for Anti-Kickback Statute, Stark law and Medicare lack of medical necessity violations
United States ex rel. Bates and Patrick v. Kyphon, Inc.– Represented several health systems in the long-running Medicare short stay Kyphoplasty medical necessity False Claims Act qui tam
United States ex rel. Cortinas v. Midtown Imaging, LLC, et al. – Obtained favorable mediated resolution of False Claims Act Anti-Kickback allegations
Advised senior management and the board of directors of a global manufacturer in connection with whistleblower allegations of employee misconduct
Represented a major pharmaceutical manufacturer in a joint U.S. Senate and U.S House of Representatives congressional investigation of pharmaceutical product price increases
Represented several employees of a pharmaceutical manufacturer during federal grand jury proceedings in an Off Label Promotion civil/criminal investigation
Represented department head of an academic medical center during a federal criminal investigation of Anti-Kickback allegations against medical device company Olympus
Obtained declination and dismissal with prejudice of False Claims Act allegations of Medicare false billing assert against a national rehabilitation hospital chain
Represented a global U.S. defense contractor in connection with a voluntary disclosure to the U.S. Department of Defense of contract billing compliance concerns
Assisted a pharmaceutical manufacturer in achieving compliance with court-ordered remedial steps involving enhancements to corporate by-laws and regulatory affairs responsibilities triggered by a shareholder derivative case
Represented U.S. subsidiary of a global gaming company in connection with District of Columbia Office of Attorney General investigation of government contract compliance