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Theresa C. Carnegie

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[email protected]

+1.202.661.8710

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Theresa’s practice handles transactional, regulatory, and fraud and abuse matters. She has a deep understanding of the legal and business challenges facing payors, pharmacies, and others participating in the pharmaceutical supply chain. And she is particularly known for her insight into the issues affecting pharmacy benefit managers. Theresa counsels clients on the ins and outs of establishing business relationships and operating within the regulatory framework — providing practical, effective guidance. She is also an editor of and frequent contributor to Mintz’s Health Law & Policy Matters blog.

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.

Education

  • Duke University (JD)
  • Bowdoin College (BA)

Experience

  • Advised a global health care company on a variety of issues in connection with its acquisition of several health plans and provider groups, including health care regulatory due diligence, health care regulatory advice regarding transaction structure and strategy, and preparation of regulatory notices and other filings.
  • Represented a national specialty pharmacy provider in connection with an internal investigation and audit of various compliance practices, as well as assistance with a response to a government investigation.

Recognition & Awards

  • Chambers USA: District of Columbia (Up and Coming) – Healthcare (2014, 2015)
  • Nightingale’s Healthcare News: Outstanding Young Healthcare Lawyers (2005)
  • Phi Beta Kappa

Languages

- Spanish

Recent Insights

News & Press

Events

Viewpoints

Viewpoint
The Trump Administration is moving full speed ahead with its proposals under the Blueprint to Lower Drug Prices (the “Blueprint”). Earlier this week, the Centers for Medicare & Medicaid Services (“CMS”) released a proposed rule that would require pharmaceutical manufacturers to disclose the list price of their pharmaceutical products in direct-to-consumer (“DTC”) television ads (the “Proposed Rule”).
In May, the Trump Administration announced its Blueprint to Lower Drug Prices and HHS Secretary Azar issued a Request for Information seeking comments from interested parties “to help shape future policy development and agency action” related to drug pricing issues.
On Friday, after weeks of delay, the President finally delivered his Drug Pricing Speech and released the HHS Blueprint detailing the Trump Administration's plan to lower drug prices and reduce out-of-pocket costs.
A bipartisan congressional effort is underway to convince CMS to reverse its biosimilar reimbursement policy implemented under the Obama administration. We discussed the current reimbursement policy in a March 2016 blog post when CMS initially released the guidance.  CMS implemented the controversial guidance as a final rule in October 2016.
Last week, the California Assembly Committee on Business and Professions voted in favor of Assembly Bill 315.
In July 2015, we posted about the N.Y. Attorney General’s False Claims Act (FCA) settlements with Trinity HomeCare and its related entities, and how the case provided insight into the future of FCA enforcement.  We identified five key trends based on the settlements.
As the healthcare industry moves towards value-based purchasing, pay-for-performance, and other payment reform models, industry leaders have identified federal fraud and abuse laws as a barrier to full implementation of such models.
The pharmacy industry continues to be under scrutiny from all angles.  As legislative, agency, and enforcement priorities take shape under the new administration, the industry is faced with what seems like daily developments in terms of policy updates, legislation, and potential regulation.
There has been much controversy over the Medicare Part B payment demonstration proposed by the Center for Medicare and Medicaid Innovation (CMMI) in March 2016.
Please join Mintz Levin for a webinar discussing health care fraud enforcement in the pharmacy and pharmaceutical industry on October 26, 2016 at 1 pm (ET). My colleagues Theresa Carnegie, Larry Freedman, and Ellyn Sternfield, members of Mintz Levin’s Health Law and Health Care Enforcement Defense practices, will discuss enforcement trends facing the industry.

News & Press

Mintz is advising a consortium of investors led by TPG Capital and Welsh, Carson, Anderson & Stowe in their acquisition of Kindred Healthcare, Inc. The definitive agreement totals approximately $4.1 billion in cash including the assumption or repayment of net debt.
Mintz's Theresa C. Carnegie and Rodney L. Whitlock are speaking at the Fifth Annual Pharmacy Benefit Oversight & Compliance Conference. The event brings together professionals from health plans, pharmacy benefit managers, pharmacies, and pharmaceutical manufacturers
The 2015 Chambers USA: America's Leading Lawyers for Business guide names 52 Mintz, Cohn, Ferris, Glovsky and Popeo, P.C.  attorneys as “Leaders in Their Fields.”