Theresa has extensive experience advising clients on all aspects of the pharmaceutical supply chain. Her practice involves advising industry stakeholders on a range of business, legal, transactional, and compliance matters. Theresa combines her multilayered industry knowledge with a deep understanding of applicable federal and state legal frameworks, in particular federal and state fraud and abuse laws. She provides clients with strategic counseling and creative business modeling that considers legal restrictions and regulatory risk in light of innovation and business goals.
PBMs and Plans
Theresa applies her comprehensive knowledge of the PBM industry, the legal landscape, and relevant policy initiatives to provide insightful and strategic counsel to plans and PBMs on all aspects of their operations. She regularly assists PBMs and plans in evaluating and structuring innovative strategic alliances, payment structures, and collaborations. She has extensive experience in:
- PBM Service Agreements from both the PBM and plan perspective
- Rebate Contracting, including value-based and outcomes-based rebating arrangements
- Rebate Aggregator and Formulary Service Arrangements
- Pharmacy Network Contracting
- Workers Compensation PBMs
Specialty Pharmacies
Theresa counsels independent and plan/PBM-affiliated specialty pharmacies on regulatory, operational, and contracting matters. She assists specialty pharmacies with:
- Drug Purchase and Service Arrangements
- Fraud and abuse risks in connection with arrangements with pharmaceutical manufacturers
- Payor Relationships
- Wholesaler Arrangements
- Prescription Drug Adherence Programs
- State Pharmacy Law Requirements
- Medicare Part D Regulatory Requirements
Drug Distribution and Procurement
Theresa knows that understanding the interaction among all entities in the pharmaceutical supply chain is critical to providing practical, business oriented advice and services. In addition to plans, PBMs, and pharmacies, she advises a variety of different stakeholders in the pharmaceutical supply chain, including:
- Providers negotiating national drug supply and procurement agreements
- Group Purchasing Organizations
- Reimbursement HUBs
- Co-pay and Coupon Program Administrators
Innovative and Direct-to-Consumer Drug Discount Programs
Theresa advises entrepreneurial health care providers on innovative platforms for the delivery of prescription drugs, pharmacy benefits, and drug discounts, including.
- Prescription Drug Discount Cards
- Direct-to-Consumer Discount Offerings
- Disruptor and alternative model PBM services
Digital Pharmacy Services
Theresa advises telehealth technology developers, telehealth providers, and pharmacies on federal and state regulatory schemes applicable to telehealth participation in the pharmaceutical supply chain and the provision of digital pharmacy services. She counsels clients on fraud and abuse requirements, provides contracting support, and assists with structural considerations such as state corporate practice of medicine (CPOM) requirements.
M&A and Transactional Matters
Theresa regularly represents clients in connection with their investment in the pharmaceutical supply chain. She uses her extensive knowledge of the pharmaceutical supply chain to advise clients investing in the industry on structural considerations, corporate matters, regulatory requirements and compliance risks, and business challenges and opportunities. Theresa assists clients in both M&A transactions and private equity investments and has deep experience in contracting matters, complex due diligence reviews, fraud and abuse risks, licensing, and regulatory and change of ownership (CHOW) filings.
COVID-19 Matters
Most recently, Theresa has advised clients on the impact of COVID-19 on the pharmaceutical supply chain, including its impact on state pharmacy law requirements, Medicare Part D benefit design requirements, and contracting arrangements.
Theresa is a frequent author and speaker on regulatory and policy issues affecting pharmacy benefits and the pharmaceutical supply chain and a regular contributor to the firm’s Health care Viewpoints.
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.
viewpoints
Trump Signs Most-Favored-Nation Executive Order - Potential Impact on Drug Supply Chain
May 14, 2025 | Blog | By Theresa Carnegie, Lauren Moldawer, Bridgette Keller, Sophia Temis
After significant fanfare and anticipation, President Trump issued his “Delivering Most-Favored Nation Prescription Drug Pricing to American Patients” Executive Order (Executive Order) this week. The Executive Order seeks to reduce the price of drugs by requiring manufacturers to offer the United States most-favored-nation pricing, or in other words, the lowest price offered to any “comparably developed” foreign country that pays for the same drugs.
Arkansas Law Takes Unprecedented Step to Prohibit PBM Ownership of Pharmacies
May 6, 2025 | Blog | By Theresa Carnegie, Hassan Shaikh, Samantha Hawkins
Arkansas Governor signed Act 624 on April 16, 2025, banning PBMs from acquiring or holding a direct or indirect interest in a pharmacy. This state-led move may inspire similar laws elsewhere.
Trump Administration Issues Drug Pricing Executive Order
April 30, 2025 | Blog | By Theresa Carnegie, Xavier Hardy, Samantha Hawkins, Abdie Santiago
On April 15, 2025, President Trump issued an Executive Order instructing federal agencies to implement a variety of drug pricing reforms. The Executive Order addresses drug pricing from several different angles, including pharmacy benefit manager (“PBM”) competition and transparency, Medicare and Medicaid drug pricing, international importation, and drug manufacturer competition (the “Executive Order”).
The Executive Order, which is the first significant action taken by the current Administration to address drug prices, echoes initiatives and policy statements announced during the first Trump Administration. However, most of the drug pricing reforms announced during the first Administration were never fully implemented. It is unclear how many of the proposals in this Executive Order will ultimately be implemented, but it does provide the clearest outline yet of the Administration’s policy priorities regarding drug prices.
Mintz IRA Update — Fourth Edition: Q1 2025
February 13, 2025 | Article | By Rachel A. Alexander, Theresa Carnegie, Tara E. Dwyer, Lauren Moldawer, Hassan Shaikh, Stephnie John, Madison Castle, Mitchell Clough, Xavier Hardy, Samantha Hawkins, Alexander Hecht, Abdie Santiago
Mintz’s Pharmacy Benefits and PBM Contracting Practice is pleased to present the ‘Fourth Edition: Q1 2025’ of our Mintz IRA Update, a regular publication that delves into developments of the Inflation Reduction Act of 2022 (IRA) and their impact on pharmaceutical supply chain stakeholders.
PBM Policy and Legislative Update — Winter 2025
February 10, 2025 | Blog | By Theresa Carnegie, Tara E. Dwyer, Rachel A. Alexander, Lauren Moldawer, Bridgette Keller, Priyanka Amirneni, Madison Castle, David Gilboa, Xavier Hardy, Samantha Hawkins, Stephnie John, Alison H. Peters, Pamela Polevoy, Abdie Santiago, Hassan Shaikh, Sophia Temis
The PBM Policy and Legislative Update — Winter 2025 edition builds upon prior PBM Policy and Legislative Updates and summarizes activity from October through December (2024) that affects the PBM industry. It highlights (i) federal activities, (ii) state activities, and (iii) other noteworthy events and trends affecting the PBM industry.
Massachusetts Aligns with National Trends and Enacts Sweeping Legislation to Regulate Pharmaceutical Benefit Managers
January 24, 2025 | Blog | By Theresa Carnegie, Bridgette Keller, David Gilboa, Priyanka Amirneni
On the heels of a nationwide push to regulate pharmacy benefit managers (PBMs), Massachusetts enacted a landmark piece of legislation to increase transparency and oversight within the pharmaceutical supply chain, specifically targeting PBMs. Signed into law by Governor Healey on January 9, 2025, the comprehensive bill, titled “An Act Relative to Pharmaceutical Access, Costs and Transparency” (the Act), introduces a multifaceted approach that aims to reduce prescription drug costs, enhance data transparency, and impose stronger oversight of PBMs and pharmaceutical manufacturers.
PBM Update: Special Edition - FTC Releases Second Interim Staff Report in PBM Inquiry
January 23, 2025 | Alert | By Rachel A. Alexander, Theresa Carnegie, Tara E. Dwyer, Joseph Miller, Lauren Moldawer, Bridgette Keller, Samantha Hawkins, Payton Thornton
In this Special Edition of the PBM Policy and Legislative Update, the Mintz Health team partnered with our Antitrust colleagues to analyze the FTC’s Second Report titled Specialty Generic Drugs: A Growing Profit Center for Vertically Integrated Pharmacy Benefit Managers.
PBM Policy and Legislative Update — Fall 2024
November 22, 2024 | Blog | By Rachel A. Alexander, Tara E. Dwyer, Theresa Carnegie, Bridgette Keller, Madison Castle, David Gilboa, Xavier Hardy, Samantha Hawkins, Stephnie John, Lauren Moldawer, Alison H. Peters, Abdie Santiago, Hassan Shaikh, Sophia Temis
Building upon prior issues and summarizing activity from July through September, the Fall 2024 PBM Update highlights federal legislative activity and oversight, state legislative activity and oversight, and other noteworthy events and trends affecting the PBM industry.
CMS 2026 IRA Price Negotiations Results Likely to Create Upstream and Downstream Effects
August 20, 2024 | Blog | By Rachel A. Alexander, Theresa Carnegie, Xavier Hardy, Alison H. Peters, Madison Castle
On August 15, 2024, CMS announced the results of the first round of the negotiated prices between CMS and participating drug manufacturers for the 10 selected drugs under the Inflation Reduction Act’s (IRA) Medicare Drug Price Negotiation Program (MPN or Program). In all, reactions to the MPN results varied: Reuters reported that executives from four of the manufacturers selected in the first round of negotiations stated that they do not expect the negotiated prices to significantly impact their businesses; meanwhile, in its press release announcing the maximum fair prices (MFPs), CMS touted an estimated $1.5 billion in Medicare prescription drug out-of-pocket cost savings for Medicare beneficiaries when the negotiated prices go into effect in 2026.
PBM Policy and Legislative Update — Summer 2024
July 31, 2024 | Blog | By Theresa Carnegie, Tara E. Dwyer, Rachel A. Alexander, Bridgette Keller, Madison Castle, David Gilboa, Xavier Hardy, Samantha Hawkins, Stephnie John, Pat Ouellette, Alison H. Peters, Abdie Santiago, Hassan Shaikh, Sophia Temis
News & Press
Despite Vaccine Spotlight, RFK Jr. A Health Policy 'Unknown'
November 15, 2024
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.
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.
Healthy Returns: What’s Next In The Legal Fight Over Medicare Drug Price Negotiations
March 13, 2024
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.
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.
HHS Pushes Back on Accumulator Ruling, Prompting Wait-and-See Situation
December 21, 2023
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.
4 Pharma Industry Arguments Against CMS Drug Pricing Plan
September 29, 2023
Theresa Carnegie, Lauren Moldawer, and Hassan Shaikh co-authored an article published by Law360 on the Inflation Reduction Act's Medicare drug pricing negotiation program.
Big Pharma’s Fight Over Medicare Drug Price Negotiations Faces Multiple Challenges
September 11, 2023
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.
Medicare’s 10-Drug List: The Industry Reacts
August 30, 2023
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.
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.
Five Mintz Attorneys Named 2020 BTI Client Service All-Stars
December 11, 2020
Trump Unveils Disputed, Long-Shot Drug Rules Upending System
November 23, 2020
Mintz Attorney Theresa C. Carnegie and ML Strategies Vice President Rodney L. Whitlock to Speak at Fifth Annual Pharmacy Benefit Oversight & Compliance Conference
November 07, 2016
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.
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.
Events & Speaking
Examining the Impact of COVID-19 on Pharmacy Benefits and the Pharmaceutical Supply Chain
American Health Law Association Annual Meeting
Online Event
4th Annual Mintz /ML Strategies Pharmacy & Pharmaceutical Industry Summit
Mintz and ML Strategies
Boston, MA
3rd Annual Mintz /ML Strategies Pharmacy & Pharmaceutical Industry Summit
Mintz and ML Strategies
Boston, MA
3rd Annual Mintz /ML Strategies Pharmacy & Pharmaceutical Industry Summit
Mintz and ML Strategies
Boston, MA
Pharmacy Benefits and Pharmaceuticals: State of the Industry Update
AHLA
Marriott Chicago Downtown, Magnificent Mile, Chicago, IL
4th Annual Pharmacy Benefit Oversight & Compliance Conference
CBI
16770 North Perimeter Drive Scottsdale, AZ
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, 2024)
Recognized by The Legal 500 United States for Healthcare: Service Providers (2024)
Nightingale’s Healthcare News: Outstanding Young Healthcare Lawyers (2005)
Phi Beta Kappa
