Theresa counsels health care clients on a variety of transactional, regulatory, and fraud and abuse matters.
Theresa focuses much of her practice on counseling health plans, pharmacy benefit managers, pharmacies, device manufacturers, and distributors on regulatory and compliance matters. Her practice extends to counseling on drug pricing and reimbursement issues, Medicare Advantage and Medicare Part D compliance, and the regulatory requirements under the Affordable Care Act and state health insurance exchanges. Theresa has extensive experience drafting, negotiating, and structuring PBM agreements, retail, mail and specialty pharmacy agreements, GPO agreements, and pharmaceutical purchase, distribution, and rebate agreements. She also regularly counsels these clients on compliance with federal and state fraud and abuse laws, the PhRMA and AdvaMed Codes, state disclosure and gift ban laws, and state licensure laws.
Theresa also specializes in representing clients in connection with mergers and acquisitions, joint ventures, strategic affiliations, complex service agreements, provider contracts, network development programs, and general contracting. Theresa advises clients on the structuring and legal, practical, and fraud and abuse implications of these business arrangements and transactions. She has served as health regulatory counsel on managed care, PBM, pharmacy, laboratory, behavioral health, anesthesiology, DME, and practice management company transactions. Theresa also has deep experience assisting private equity firms in connection with their investment in the health care industry and the day-to-day regulatory compliance of their portfolio companies.
Other aspects of Theresa’s practice include day-to-day counseling on matters related to the anti-kickback statute, the Stark law, and state statutes prohibiting kickbacks and self-referrals. Theresa regularly advises client on the structuring of business arrangements to comply with state regulatory restrictions such as corporate practice of medicine and fee-splitting prohibitions. Theresa is also an Editor of and a frequent contributor to Mintz's Health Law blog, Health Law & Policy Matters.
More Legal and Business Bylines From Theresa C. Carnegie
- PBM Policy and Legislative Update — Winter 2024 - (Posted On Tuesday, April 09, 2024)
- HHS Court Filings Indicate that Agency Intends to Preserve Copay Accumulators - (Posted On Monday, December 04, 2023)
- Court Strikes Down HHS Rule on Copay Accumulators: Implications for Health Plans and PBMs - (Posted On Monday, October 09, 2023)
- OIG Approves Manufacturer’s Offer of Free Genetic Testing - (Posted On Thursday, April 14, 2022)
- Biden Administration’s Drug Pricing Plan Calls for Bold Action by Congress - (Posted On Monday, September 13, 2021)
- Another Battle in the Political Fight Over How to Address High Drug Prices - (Posted On Monday, August 16, 2021)
- Biden Administration Takes Aim at Rising Drug Prices through its Executive Order on Promoting Competition - (Posted On Tuesday, July 20, 2021)
- Fourth Time’s the Charm? How COVID-19 May Spur Congress to Pass Legislation Expanding Coverage for Pharmacist Services - (Posted On Wednesday, May 12, 2021)
- The American Families Plan & A Call for Drug Pricing Legislation - (Posted On Monday, May 10, 2021)
- HHS Issues Controversial Drug Rebate Reform Final Rule - (Posted On Wednesday, November 25, 2020)