Theresa C. Carnegie: Lawyer with Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

Theresa C. Carnegie


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Experience & Credentials

Practice Areas

  • Fraud & Abuse, Compliance & Regulatory Counseling
  • Mergers, Acquisitions & Other Transactions
  • Medicare, Medicaid & Commercial Payor Coverage & Payment
  • Life Sciences
  • Accreditation, Licensing & Certification
  • Health Law
  • Health Care
Contact InfoTelephone: 202.661.8710
Fax: 202-434-7400
Internet: Each Attorney's Internet Address takes the following form: first initial, last name (e.g.,
University Bowdoin College, B.A., 1995
Law SchoolDuke University, J.D., 1999
Admitted1999, Massachusetts; 2001, District of Columbia

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 Levin's Health Law blog, Health Law & Policy Matters.

•Mintz Levin Attorneys Theresa C. Carnegie and Ellyn L. Sternfield to Speak at Pharmacy Benefit Oversight and Compliance Congress, (11.10.2014)
•Fifty-One Mintz Levin Attorneys Featured in Chambers USA 2014 Guide, (05.23.2014)
•Mintz Levin Attorneys Theresa C. Carnegie and Thomas S. Crane to Present at AHLA Fraud and Compliance Forum, (09.26.2013)
•Quoted in Docs Lobby to Keep Stark Exemptions, MedPage Today (09.06.2013)
•Quoted in Bill to Scrap Stark Law In-Office Ancillary Services Exception Fiercely Opposed, Inside Health Policy (08.16.2013)
•Quoted in With Stark Law Loophole Under Fire, Docs Eye Bottom Line, Law360 (08.09.2013)
•Quoted in CMS Ratings Push Pressures Medicare Plans to Improve, Law360 (10.11.2012)
•Mintz Levin Elevates Six Attorneys to Members of the Firm, (04.28.2011)

Awards & Recognitions
Chambers USA: District of Columbia (Up and Coming) - Healthcare (2014)
Nightingale's Healthcare News: Outstanding Young Healthcare Lawyers (2005)
•Phi Beta Kappa

•Co-author, IRS Ruling Permits Inclusion of “Friendly PCs” in Consolidated Federal Income Tax Returns, Health Care Alert (02.13.2015)
•Co-author, OIG Special Advisory Bulletin Provides Guidance on Application of Federal Anti-Kickback Statute to Pharmaceutical Manufacturer Copayment Coupons, BNA's Health Care Fraud Report (10.15.2014)
•Co-author, Proposed Rule Issued by OIG Realigns Its Enforcement Views with Health Care Reform Goals, Health Care Alert (10.09.2014)
•Author, Recent Drug Pricing Trends- What Do These Mean for Your Formulary, Formulary Watch (10.08.2014)
•Co-author, CMS Proposes Major Changes to Medicare Part C and Part D, BNA's Medicare Report (03.07.2014)
•Co-author, CMS Proposes Major Rule Changes to Increase Payment Accuracy and Improve Program Integrity in Medicare Part C and Part D, BNA's Health Care Fraud Report (03.05.2014)
•Co-author, CMS Proposes Major Changes to Medicare Parts C and D, Health Law Advisory (01.21.2014)
•Co-author, New Bill Proposes to Eliminate Stark Law Exception for Certain In-Office Ancillary Services, Med Monthly Magazine (09.2013)
•Co-author, Caution: Risk Adjustment Hurdles Facing Plans and Providers Under the Affordable Care Act, BNA's Health Insurance Report (07.17.2013)
•Co-author, 2014 Final Call Letter: CMS Raises Medicare Advantage Rates but Foreshadows Other Significant Program Changes, Health Law Advisory (04.16.2013)
•Co-author, Medicare Star Ratings-What Plan Sponsors Need to Know, BNA's Medicare Report (11.29.2012)
•Co-author, Fiscal Year 2013 Work Plan Highlights OIG's Medicare Parts C and D Priorities, Health Law Advisory (10.09.2012)
•Author, Legal Challenges, Risks of Rx Drug Adherence Programs, Law360 (07.09.2012)
•Co-author, Electronic Health Record Donations: Best Practices to Minimize Liability, G-2 Compliance Report (02.01.2011)

Speaking Engagements
•Speaker, How the PBM World Continues to Evolve, Pharmacy Benefit Oversight and Compliance Congress, CBI, Chicago, IL (11.12.2014)
•Speaker, What Do the Proposed Changes to Medicare Parts C and D Mean for Your Business?, Mintz Levin, Webinar (01.29.2014)
•Speaker, Fundamentals of PBM Compliance in the Health Reform Era, CBI, Chicago, IL (11.13.2013)
•Speaker, Fundamentals of Healthcare Valuation for Health Lawyers, Fraud and Compliance Forum, American Health Lawyers Associaton (AHLA), Baltimore, MD (09.30.2013)
•Speaker, Healthcare Transactions and Compliance with State and Federal Laws and Regulations, Strafford Publications, Webinar (12.20.2012)

Recognitions & Awards
Chambers USA: District of Columbia (Up and Coming) - Healthcare (2014)
Nightingale's Healthcare News: Outstanding Young Healthcare Lawyers (2005)
•Phi Beta Kappa


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IRS Ruling Permits Inclusion of “Friendly PCs” in Consolidated Federal Income Tax Returns
Theresa C. Carnegie,Ryan J. Cuthbertson,Carrie A. Roll,Jonathan R. Talansky, March 30, 2015
On December 19, 2014, the Internal Revenue Service (“IRS”) issued a private letter ruling (the “Ruling”) allowing corporations that manage physician practices through a so-called “friendly physician” arrangement to treat the physician practices as members of the...

Key Takeaways from OIG’s 2015 Work Plan
Theresa C. Carnegie,Laurence J. Freedman,Kimberly J. Gold, November 14, 2014
The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) released its Fiscal Year 2015 Work Plan on October 31. The Work Plan provides the OIG’s planned reviews and activities with respect to HHS programs and operations during the current fiscal year and beyond.

Proposed Rule Issued by OIG Realigns Its Enforcement Views with Health Care Reform Goals
Theresa C. Carnegie,Thomas S. Crane,Carrie A. Roll,Stephanie D. Willis, October 15, 2014
Fridays never seem to be slow in the health care regulatory world. On Friday, October 3rd, the HHS Office of the Inspector General (OIG) issued a highly anticipated proposed rule (the Proposed Rule) that provides amendments to the Anti-Kickback Statute’s regulatory safe harbors (AKS Safe...

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Office Information

Theresa C. Carnegie

701 Pennsylvania Avenue, N.W.
WashingtonDC 20004-2608


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