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Theresa C. Carnegie

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[email protected]

+1.202.661.8710

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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)

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

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.

The Future of the Medicare Part B Payment Demo under a Republican-held Congress

November 29, 2016 | Blog | By Theresa Carnegie, Eli Greenspan, Lauren Moldawer

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.

Dionne Lomax named Vice Chair of Publications for the AHLA Antitrust Practice Group

July 21, 2016 | Blog | By Theresa Carnegie, Karen Lovitch

Dionne Lomax named Vice Chair of Publications for the AHLA Antitrust Practice Group.

Recap: 2016 Mintz/ML Strategies Pharmacy Industry Summit

May 19, 2016 | Blog | By Theresa Carnegie

The pharmacy industry is under increasing scrutiny from all angles. Whether at the legislative or agency level, Washington as well as many states seem intent on addressing perceived issues surrounding drug pricing, reimbursement, and program integrity.

Four Days Until The Mintz/ML Strategies Pharmacy Industry Summit

May 6, 2016 | Blog | By Susan Berson, Theresa Carnegie, Ellyn Sternfield

Here in Washington, it seems everyone has an idea on a drug “fix”:  amendments to the provisions governing Medicare reimbursement, new rebate requirements, changes to price reporting measures, revisions to the 340B Drug Discount Program, etc. Proposals are interesting, but will Congress actually do anything?  If anything is actually going to pass, it has to get through the Senate.

Five Days Until The Mintz/ML Strategies Pharmacy Industry Summit

May 5, 2016 | Blog | By Susan Berson, Theresa Carnegie, Ellyn Sternfield

Following our first panel discussing Drug Pricing Challenges and Opportunities, the second panel, which Theresa is moderating involves a subject near and dear to the heart of many of our clients: The New Wave of Value-Based Pricing and Contracting.

Six Days Until The Mintz/ML Strategies Pharmacy Industry Summit

May 4, 2016 | Blog | By Susan Berson, Theresa Carnegie, Ellyn Sternfield

We are thrilled that our inaugural Pharmacy Industry Summit is now less than a week away.  The Summit is next Tuesday May 10th, 2016, here in our DC offices.  Since we started planning for the Summit many months ago, this hottest of topics that we chose to cover, drug pricing, has become even hotter.
The pharmacy industry is under increasing scrutiny from all angles. Whether at the legislative or agency level, Washington as well as many states seem intent on addressing perceived issues surrounding drug pricing, reimbursement, and program integrity.

Tackling Drug Prices: CMS and PhRMA Propose Steps to Promote Value-Based Purchasing

March 15, 2016 | Blog | By Theresa Carnegie, Lauren Moldawer

Last week, the Centers for Medicare & Medicaid Services (CMS) and the Pharmaceutical Research and Manufacturers of America (PhRMA) released proposals to address recent criticism over rising drug prices.

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.”

Events