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
- Trump Signs Executive Orders Aimed at Tying Domestic Drug Prices to Foreign Prices - (Posted On Tuesday, September 15, 2020)
- OIG Approves Discount Medical Plan Referral Arrangement - (Posted On Monday, July 06, 2020)
- CMS Proposes Rule to Pave the Way for Value-Based Drug Purchasing - (Posted On Friday, June 26, 2020)
- Massive House Bill Proposes Mandatory Coverage of COVID-19 Vaccines and Therapies - (Posted On Tuesday, May 19, 2020)
- HHS Proposes Sweeping Changes to AKS and Stark Law, Part 3: Personal Services and Management Contracts, Outcomes-Based Payments, and Warranties - (Posted On Wednesday, October 23, 2019)
- HHS Proposes Sweeping Changes to AKS and Stark Law, Part 2: Cybersecurity Technology and Electronic Health Records - (Posted On Monday, October 21, 2019)
- HHS Proposes Sweeping Changes to AKS and Stark Law, Part 1: Value-Based Arrangements - (Posted On Tuesday, October 15, 2019)
- HHS Proposes Sweeping Changes to Anti-Kickback Statute and Stark Law - (Posted On Thursday, October 10, 2019)
- Trump Administration Withdraws Proposed Rebate Rule - (Posted On Thursday, July 11, 2019)
- HHS Proposes to Remove Drug Rebate Protections - (Posted On Friday, February 01, 2019)