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Theresa C. Carnegie

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[email protected]

+1.202.661.8710

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Theresa is a nationally recognized health care and pharmaceutical supply chain attorney who advises clients on PBM strategy, drug pricing, and the regulatory and transactional issues shaping the pharmaceutical industry. With more than 25 years of experience, she combines sophisticated legal judgment with deep industry insight to help clients navigate complex commercial, regulatory, and policy environments.

Theresa has extensive experience structuring, drafting, and negotiating transactions across the pharmaceutical supply chain, including PBM service agreements, retail, mail, and specialty pharmacy arrangements, pharmaceutical purchase and distribution agreements, GPO arrangements, and rebate and value-based contracting models. She regularly advises clients on reimbursement structures, drug pricing strategy, and compliance with federal and state fraud and abuse laws.

Her practice spans health care transactions and investment matters, where she represents clients in mergers, private equity and venture capital investments, and strategic collaborations. Theresa supports regulatory diligence, licensing, change-of-ownership filings, and risk assessment across complex health care and pharmaceutical supply chain deals.

Theresa counsels PBMs, health plans, pharmacies, and distribution stakeholders on operational, regulatory, and compliance matters across commercial, Medicare Advantage, Part D, and multistate health care markets. She helps clients evaluate structural design considerations, policy developments, and business opportunities associated with innovation in drug delivery, reimbursement, and emerging service models.

Recognized as an industry thought leader, Theresa frequently communicates timely updates on regulatory, policy, and market developments affecting clients in the pharmaceutical supply chain. She is a regular author and speaker on health care regulatory and PBM-related issues.

Theresa is a member of the Firm's Policy Committee.


Theresa has exceptional knowledge and expertise. She is creative and a highly effective negotiator.

- Healthcare Client, Chambers USA 2025

Experience

  • Represented Cigna as health regulatory counsel in its acquisition of Express Scripts.
  • Represented Catamaran (f/k/a CatalystRx) in the structuring and negotiation of its PBM services arrangement with CIGNA.
  • Represented national worker’s compensation PBM in connection with multiple worker’s compensation PBM acquisitions.
  • Represented a national specialty pharmacy provider in connection with an internal compliance audit and investigation and response to government investigation.
  • Advised national pharmacy chain in multiple specialty pharmacy and long-term care pharmacy acquisitions.
  • Represented SingleCare, a discount medical and pharmacy card operator (“DMPO”), in its contracting with pharmacies, providers and other vendors.
  • Served as regulatory counsel to a consortium of investors led by TPG Capital and Welsh, Carson, Anderson & Stowe in their $4.1 billion acquisition of Kindred Healthcare, Inc. (NYSE:KND). The transaction was recognized by The Deal as the 2018 Private Equity Deal of the Year.
  • 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.
  • Advised national pharmacy chain in connection with government agency arrangement to provide accessible COVID-19 testing.
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viewpoints

HHS Issues Controversial Drug Rebate Reform Final Rule

November 25, 2020 | Blog | By Theresa Carnegie

On Friday, November 20, the Administration took bold action by releasing a contentious rule designed to disrupt the drug supply chain status quo. The Pharmaceutical Rebates final rule will alter how drug discounts offered by pharmaceutical manufacturers to plan sponsors or their PBMs, and service fees paid by such manufacturers to PBMs, are treated for purposes of the federal Anti-Kickback Statute (AKS). As we discuss in this alert, the policies set out in this final rule are not surprising, in light of other actions taken by the Trump Administration to date. However, the transformational effects the rule will have on the drug supply chain, coupled with a lack of consensus among lawmakers and industry stakeholders about the best approach to drug pricing reform, ensures that litigation of this new rule will inevitably ensue.
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President Trump has followed through on his threat to pharmaceutical manufacturers, signing new executive orders on Sunday that take a preliminary step toward the President’s goal of tying domestic drug prices to the prices manufacturers charge in foreign countries. The “Executive Order on Lowering Drug Prices by Putting America First” follows a trio of drug pricing-related executive orders the administration issued this past July. At that time, President Trump also signed a different executive order with the same name, but withheld the order in an attempt to force pharmaceutical manufacturers to the negotiating table. The President warned manufacturers that if they did not propose alternatives to lower drug pricing within 30 days, his administration would take action to implement its previously-abandoned plan to peg U.S. drug prices to foreign prices. Sunday’s order follows weeks of negotiations between the White House and drug manufacturers that have apparently not resulted in any mutually-acceptable proposals for lowering American drug prices.
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CMS Announces One-Year Delay in Finalizing Highly Anticipated Stark Law Reform

August 27, 2020 | Blog | By Karen Lovitch, Rachel Yount

On Wednesday, August 26th, the Centers for Medicare & Medicaid Services (CMS) issued a notice extending the deadline to finalize significant proposed changes to the Physician Self-Referral Law (commonly known as the Stark Law) announced last year. CMS published the proposed rule on October 17, 2019 in tandem with a companion proposed rule issued by Department of Health and Human Services (HHS) Office of Inspector General (OIG) with equally sweeping changes to the Anti-Kickback Statute (AKS). Both rules were issued as part of CMS’s Regulatory Sprint to Coordinated Care and offer a number of industry-friendly changes designed to reduce regulatory burden associated with the Stark Law and the AKS and allow for increased adoption of value-based arrangements.
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OIG Approves Discount Medical Plan Referral Arrangement

July 6, 2020 | Blog | By Theresa Carnegie, Jane Haviland

On June 26, the Department of Health and Human Services Office of the Inspector General (OIG) issued Advisory Opinion No. 20-03 approving the payment by a discount medical plan organization (DMPO) of a five dollar ($5.00) fee to chiropractors for the referral of new members to the DMPO.  OIG determined that even though the arrangement could result in prohibited remuneration, it would not impose administrative sanctions or civil monetary penalties for violation of the federal Anti-Kickback Statute (AKS). 
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The Centers for Medicare & Medicaid Services (CMS) has taken another step to further the adoption of value-based purchasing within the health care industry. (Readers may recall the Department of Health & Human Services’ two proposed rules – one from CMS and another from the Office of Inspector General – issued late last year, aimed at reducing barriers to value-based arrangements, which we discussed here.) CMS released its new proposed rule to “support state flexibility to enter into innovative value-based purchasing arrangements (VBPs) with manufacturers, and to provide manufacturers with regulatory support to enter into VBPs with payers, including Medicaid.”
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As the COVID-19 public health crisis continues, it is sometimes easy to forget what issues were at the forefront of our national conversation before the pandemic. It was mere months ago when Congress appeared to be edging closer to a deal on legislation addressing drug pricing. While the focus on drug pricing issues may have shifted of late, the American public’s access to drugs—and, more recently, vaccines—remains a critical public health issue, perhaps now more than ever. As Congress works feverishly to pass legislation to mitigate the effects of the COVID-19 crisis, it remains to be seen what will come of the various drug pricing proposals that were being debated earlier this session. For now, it looks like any legislative action to enhance patients’ access to drug therapies will likely come through a coronavirus-related stimulus bill, such as the one introduced by the House of Representatives last week.
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In response to the spread of COVID-19, on March 23, 2020, President Trump signed Executive Order 13910 (Order) to prevent the hoarding of health and medical resources necessary to respond to the spread of COVID-19 within the United States. Through the Order, the President delegated his authority under the Defense Production Act of 1950, 50 U.S.C. § 4512 (Act) to the Secretary of Health and Human Services (HHS). The Order authorizes HHS to protect scarce and threatened health care and medical items by designating particular items as protected under the Act (Designated Items). Once an item is designated, the Act makes it a crime for any person to accumulate Designated Items: (i) in excess of the reasonable demands of business, personal, or home consumption; or (ii) for the purpose of resale at prices in excess of prevailing market prices. In this post, we discuss four things to know in connection with the Order.
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On March 30, 2020, the Centers for Medicare & Medicaid Services (CMS) issued blanket waivers to the Stark Law that permit certain arrangements between physicians and health care providers implemented in response to COVID-19 that would otherwise violate the Stark Law. The waivers, which are numerous and fairly broad, offer health care entities significant flexibility to combat COVID-19 in ways that may have otherwise violated the Stark Law, such as the ability to pay physicians hazard pay and provide personal protective equipment to physicians at a price that is below fair market value (FMV). Importantly, the waivers only apply to remuneration and referrals related to COVID-19 purposes.
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HHS Proposed Changes to AKS and Stark Law: Value-Based Arrangements

February 20, 2020 | Video | By Theresa Carnegie

Theresa Carnegie reviews both the OIG’s and the CMS’s proposed rules as they relate to the new value-based arrangements safe harbors and Stark Law exceptions.
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HHS Proposed Changes to Anti-Kickback Statute and Stark Law

February 10, 2020 | Video | By Karen Lovitch, Theresa Carnegie

Karen Lovitch, Chair of Mintz's Health Law Practice, and Theresa Carnegie, a Member in the Health Law Practice, discuss the proposed changes to the Anti-Kickback Statute (AKS) and Stark Law issued by Department of Health & Human Services (HHS) and dive into some of the key issues.
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News & Press

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Member Theresa Carnegie was quoted by Managed Healthcare Executive in an article about new bill Break Up Big Medicine Act that proposes a separation of the largest insurance companies and pharmacy benefit managers.  

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Law360 Healthcare Authority featured insights from Member Theresa Carnegie in an article focused on the Consolidated Appropriations Act of 2026 which introduces new regulations for pharmacy benefit managers, particularly aimed at fee and cost transparency.

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Member Theresa Carnegie shared insights in a Law360 Healthcare Authority article about a federal government bulletin stating that drug manufacturers will be able to sell medications directly to patients through TrumpRx, without violating federal anti-kickback laws. The article sheds light on the potential legal risks associated with excluding telehealth providers, pharmacies, and other parties not covered by the bulletin.

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The Deal quoted Member Theresa Carnegie in a recent article about how regulatory pressure on pharmacy benefit managers (PBMs) has sparked innovation and opened up investment opportunities in the industry. Increased scrutiny of larger PBMs over concerns about competition and drug prices has prompted newer PBMs to emphasize transparency.

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Member Theresa Carnegie connected with Endpoints News about the pharmaceutical industry's continued legal challenges to the Inflation Reduction Act, even as the federal government has prevailed in about a dozen cases so far. AstraZeneca, one of the companies still pushing back, recently requested more time to petition the Supreme Court following a loss in the Third Circuit.

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Mintz has earned top rankings in the 2025 edition of Legal 500 United States and Canada guides. The firm is recognized in 20 practice categories, and 78 of its attorneys are individually ranked in the guide, with several receiving recognition in more than one category. Additionally, two attorneys are featured in the "Hall of Fame," seven attorneys are named "Leading Lawyers," and five attorneys are recognized as a "Next Generation Lawyers."

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Chambers USA has recognized 43 of Mintz’s practices and 88 of its attorneys in its 2025 guide to the country’s leading law firms. Of those featured in the guide, 17 attorneys and seven practice areas were awarded Chambers’ highest ranking, Band 1. The firm expanded its rankings this year with three new practice area listings and 17 attorneys recognized for the first time or in additional categories.

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Managed Healthcare Executive featured insights from Mintz Member Theresa Carnegie, which stemmed from a recent webinar hosted by LucyRx, a fiduciary pharmacy benefit manager (PBM), about states’ efforts to regulate PBMs and their relationships with pharmacies in light of stalled federal reform. In the webinar, panelists discussed the impacts of states’ efforts to reform PBMs and their relationships with pharmacies.

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Managed Healthcare Executive quoted Mintz Member Theresa Carnegie in an article discussing Iowa’s new pharmacy benefit manager (PBM) legislation. The law aims to strengthen protections for independent pharmacies, improve their access to PBM networks, and implement stricter pricing and reimbursement requirements.

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Member Theresa Carnegie was quoted in a Managed Healthcare Executive article about the implications of a new law in Arkansas, which bans PBMs from owning pharmacies. The law is intended to improve access and affordability for patients, but it could lead to adverse effects.

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Member Theresa Carnegie was quoted by Law360 in an article about the unknowns of Robert F. Kennedy Jr.’s health policies following his nomination by President-elect Trump to head the Department of Health and Human Services. 

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Mintz has earned top rankings in the 2024 edition of Legal 500 United States guide. The firm is recognized in 14 practice categories, and 72 individual attorneys are also recognized in the guide, some in more than one category. Additionally, two attorneys are featured in the "Hall of Fame," three attorneys are named "Leading Lawyers," four attorneys are recognized as a "Next Generation Lawyers" and one attorney is recognized as a "Rising Star."

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Mintz announced today that 42 of its practices and 83 of its attorneys earned recognition in the 2024 edition of Chambers USA, a guide to the country’s leading law firms. Of those included in the guide, 18 attorneys and seven practice areas were awarded Chambers’ highest ranking, Band 1. The firm obtained new listings in three practice areas and 10 of its lawyers were recognized for the first time.

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CNBC spoke with Member Theresa Carnegie on the legal battle over Medicare drug price negotiations. Drug makers argue that such negotiations would force them to sell medicine at significant discounts, violating their due process under the Fifth Amendment. Theresa commented on the government’s initial victories and their potential impact on remaining legal challenges.

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Bloomberg Law spoke to Member Theresa Carnegie in an article discussing how four leading drugmakers are challenging the Medicare Drug Price Negotiation Program in federal court.

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MMIT quoted a recent article written by Mintz attorneys Theresa Carnegie, Xavier Hardy, and David Gilboa in a story discussing the US district court ruling that overturned a federal rule allowing health plans to exclude copayment assistance from members’ out-of-pocket costs. The article notes the Department of Health and Human Services’ current stance of refraining from immediate action.

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Theresa CarnegieLauren Moldawer, and Hassan Shaikh co-authored an article published by Law360 on the Inflation Reduction Act's Medicare drug pricing negotiation program.

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Health Payer Specialist spoke to Member Theresa Carnegie about implications resulting from the Biden administration’s plan to place drugs in the Medicare program under price negotiation.

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Theresa Carnegie's comments were featured in a PharmaVoice newsletter article analyzing the Biden administration's announcement of the first 10 drugs up for Medicare price negotiations.

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BOSTON –Mintz announced today that 39 of its practices and 81 of its attorneys earned recognition in the 2023 edition of Chambers USA, a guide to the country’s leading law firms.

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In an article published by Bloomberg Law, Mintz Member Theresa C. Carnegie was quoted on the Trump administration’s proposed foreign drug pricing rule and potential legal challenges from the pharmaceutical industry.
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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.”
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podcasts

Health Law Diagnosed – New Year's Gratitude

February 3, 2025 | Podcast | By Bridgette Keller, Alison H. Peters, Samantha Kingsbury, Theresa Carnegie, Joanne Hawana, Abdie Santiago, Stephnie John, Pamela Polevoy, Karen Lovitch, Jean D. Mancheno, Deborah Daccord, Rachel A. Alexander, Jane Haviland, David Gilboa, Kathryn Edgerton, Hassan Shaikh, Madison Castle, Laurence Freedman, Priyanka Amirneni, Samantha Hawkins, Tara E. Dwyer, Rachel Yount, Sophia Temis, Xavier Hardy

Host Of Counsel Bridgette Keller invites the Mintz Health Law team to reflect on what they’re grateful for as they prepare for the year ahead. Hear from a dynamic group of Members, Of Counsel, and Associates as they share their perspectives on what’s coming up over the horizon.

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Mintz Health Law: What We Are Grateful For

January 11, 2023 | Podcast | By Bridgette Keller

Bridgette Keller speaks with the Mintz Health Law team about what they are grateful for as they look back on a year of client service, mentorship, and working together as a team.

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Events & Speaking

Apr
28
2026

AHLA Health Plan and Managed Care Law Institute

Drug Pricing in 2026: Trump Rx and Other Developments

Virtual

Speaker
Jun
29
2020
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Speaker
Moderator
Chair
Speaker
Nov
13
2017

Pharmacy Benefits and Pharmaceuticals: State of the Industry Update

AHLA

Marriott Chicago Downtown, Magnificent Mile, Chicago, IL

Moderator
Speaker
Speaker
Nov
12
2015

4th Annual Pharmacy Benefit Oversight & Compliance Conference

CBI

16770 North Perimeter Drive Scottsdale, AZ

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Recognition & Awards

  • BTI Consulting Group: Client Service All-Star (2020)

  • Chambers USA: District of Columbia (Up and Coming) – Healthcare (2014, 2015); Chambers USA: District of Columbia – Healthcare (2023 - 2025)

  • Recognized by The Legal 500 United States for Healthcare: Service Providers (2024)

  • Nightingale’s Healthcare News: Outstanding Young Healthcare Lawyers (2005)

  • Phi Beta Kappa

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