JOHN “JACK” S. LINEHAN is a Member of the Firm in the Health Care and Life Sciences practice, in the Baltimore and Washington, DC, offices of Epstein Becker Green. His practice focuses on pharmacy law, drug distribution and reimbursement, and related fraud and abuse issues, government investigations, and litigation matters.
- Counsels drug manufacturers, distributors, pharmacy benefit managers (PBMs), insurers, retail and specialty pharmacies, and other health care providers and suppliers on a range of drug distribution and reimbursement issues, including drug supply chain licensure and regulation; drug reimbursement by private insurers and under the federal health care programs (Medicare Parts B and D, Medicaid, and TRICARE); the Drug Supply Chain Security Act (DSCSA); contract disputes between PBMs and pharmacies; drug rebates and price concessions; co-pay coupons and patient assistance programs (PAPs); co-pay coupon accumulator and maximizer programs; compounding; channel and formulary management strategies; and the structuring of hub and specialty pharmacy distribution arrangements
- Provides regulatory and compliance advice relating to business entity formation and due diligence reviews of pharmacies, distributors, and other drug suppliers and providers targeted in corporate mergers and acquisitions
- Serves as defense counsel in criminal and civil investigations and enforcement actions involving the U.S. Department of Justice (DOJ) and the Office of Inspector General (OIG) of the Department of Health and Human Services under the False Claims Act, the Anti-Kickback Statute, and the Food, Drug, and Cosmetic Act
Prior to joining Epstein Becker Green, Mr. Linehan served as a Special Assistant U.S. Attorney in the U.S. Attorney’s Office for the District of Maryland and as a Law Clerk for the Honorable Richard D. Bennett of the U.S. District Court for the District of Maryland. He has been selected to the Maryland Rising Stars list (2017) in the area of Health Law.
Mr. Linehan provides pro bono legal assistance to individuals seeking asylum and legal immigration status through the Immigration Legal Service program operated by Catholic Charities of Baltimore’s Esperanza Center.
Select Publications & Speaking Engagements
- Author, State Legislatures Spring Ahead with Restrictions on Drug Copay Accumulators, Managed Care (Apr. 2019).
- Author, Assessing the Legal and Practical Implications of Copay Accumulator and Maximizer Programs, Managed Care (Feb. 2019)
- Panelist, HHS OIG Proposed Rule on the Safe Harbor for Pharmaceutical Rebates: The Issues and Impact, Epstein Becker Green webinar (Feb. 2019)
- Panelist, Drug Pricing and Reimbursement: 2018 in Review and Outlook for 2019, Epstein Becker Green webinar (Feb. 2019)
- Speaker, Exploring the Drug Supply Chain Security Act: Implementation Issues & Impact on Pharmacy Practice, American Society of Pharmacy Law, 2018 Developments in Pharmacy Law (Nov. 2018)
- Author, Politics, Populism, and the Future of Prescription Drug Pricing Reform, PharmExec.com (Dec. 2016)
- Panelist, Compliance Issues in Contracting with Specialty Pharmacies and HUBs, 17th Annual Pharmaceutical Compliance Congress and Best Practices Forum (Oct. 2016)
- Author, Specialty Drug Copay Coupons: Despite Patient Benefits, Compliance Issues Persist, Specialty Pharmacy Times (June 2016)
- Panelist, Emerging Enforcement Issues Involving Managed Markets Activities, Pharmaceutical Summit on Business & Compliance Issues in Managed Markets (June 2016)
- Author, Drug Compounding: Cause and Cure for High Drug Prices?, PharmExec.com (Mar. 2016)
- Author, Taking Stock of Compliance Issues Impacting Specialty Pharmacy Arrangements, Specialty Pharmacy Times (Feb. 2016)
- Moderator, Structuring Specialty Pharmacy Distribution Arrangements in a Turbulent Regulatory Environment, 16th Annual Pharmaceutical Compliance Congress and Best Practices Forum (Oct. 2015)
- Author, The Legal Implications of Pharmacist Provider Status and the Transformation of an Industry, AHLA Connections (Nov. 2014)
- Speaker, The Legal Implications of Pharmacist Provider Status: The Past, Present, and Future of a Transformative Movement, American Society of Pharmacy Law 2014 Developments in Pharmacy Law (Nov. 2014)
- University of Virginia School of Law (J.D.)
- Williams College (B.A., cum laude)
- District of Columbia
- Maryland Court of Appeals
- U.S. Court of Appeals for the Fourth Circuit
- U.S. District Court, District of Maryland
- American Health Lawyers Association
- American Society of Pharmacy Law