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.
viewpoints
What PBMs and Group Health Plans Need to Know About the Department of Labor’s Proposed PBM Fee Disclosure Rule
February 9, 2026 | Blog | By Theresa Carnegie, Hassan Shaikh
On January 30, 2026, the Department of Labor released a proposed rule (Proposed Rule) that would end long‑running confusion about how ERISA disclosure obligations apply to PBMs under the Consolidated Appropriations Act, 2021, and give fiduciaries of ERISA‑covered self‑insured group health plans significantly expanded visibility into PBM services and compensation. The proposal pairs broad compensation transparency with comprehensive audit rights covering PBMs and their affiliates, agents, and subcontractors, including PBM‑affiliated brokers and consultants.
The Proposed Rule and the Consolidated Appropriations Act, 2026, both of which were announced last week, will materially impact the PBM industry, particularly PBM’s arrangements with their plan clients. Below we provide an initial summary of the Proposed Rule’s key provisions and discuss its anticipated impact on PBMs, self-insured group health plans, and other stakeholders.
Congress Passes Landmark PBM Reform in 2026 Spending Bill
February 6, 2026 | Blog | By Theresa Carnegie, Bridgette Keller, Hassan Shaikh, Abdie Santiago
On February 3, 2026, Congress passed – and the President signed – the Consolidated Appropriations Act, 2026 (2026 CAA). The legislation includes a long‑anticipated and far‑reaching package of PBM reforms. These reforms draw from the PBM Reform Act of 2025 and other legislative proposals and will significantly reshape PBM operations across the commercial market and Medicare Part D beginning in 2028–2029.
The BALANCE Model and a New Wave of CMS Drug Pricing Models
January 5, 2026 | Blog | By Theresa Carnegie, Hassan Shaikh, Attiya S. Khan, Grace Callander
On December 23, 2025, the Centers for Medicare & Medicaid Services (CMS) announced the Better Approaches to Lifestyles and Nutrition for Comprehensive hEalth (BALANCE) Model, a voluntary, alternative payment model (APM), designed to expand access to GLP-1 medications. At its core, the BALANCE Model intends to promote the use of both GLP-1 medications and lifestyle interventions to help prevent chronic conditions and combat obesity, while also managing the costs of such medications for Medicare and Medicaid beneficiaries and taxpayers.
Pharmaceutical Policy in Motion Continued: Trump Inks Nine New Drug Pricing Deals
December 23, 2025 | Blog | By Theresa Carnegie, Attiya S. Khan, Sophia Temis, Stephnie John, Hassan Shaikh
The Trump administration closes 2025 with nine major drug pricing deals, securing discounts on key medications and boosting U.S. pharmaceutical manufacturing investments.
CMS Targets Rising Drug Costs with New Guard and Globe Pilot Programs
December 23, 2025 | Blog | By Theresa Carnegie, Hassan Shaikh, Stephnie John
CMS proposes two pilot programs: GUARD and GLOBE, to curb Medicare drug costs by tying rebates to international pricing benchmarks. Public comments open until Feb. 23, 2026.
Pharmaceutical Policy in Motion: Updates on the Trump Administration’s Drug Pricing Initiatives
November 13, 2025 | Blog | By Theresa Carnegie, Hassan Shaikh, Stephnie John, Attiya S. Khan, Grace Callander
Since May, the Trump administration has used tariffs and Most Favored Nation (MFN) drug pricing threats as a means to pressure pharmaceutical manufacturers to lower drug prices in the U.S. This pressure culminated in a first-of-its-kind deal with Pfizer.
Since our last update, four other manufacturers have struck deals with the Trump administration aimed at expanding drug access and improving affordability, particularly targeting the GLP-1 and fertility pharmaceutical markets. These agreements reflect the growing consumer demand for GLP-1 drugs and IVF treatments while aligning industry leaders with the federal agenda on health care affordability. In this blog post, we’ll explore the key developments that have followed the Pfizer deal, including how other pharmaceutical companies are responding.
CMS Finalizes Key Requirements for Bona Fide Service Fees in CY 2026 Physician Fee Schedule Rule
November 12, 2025 | Blog | By Theresa Carnegie, Tara E. Dwyer, Rachel Yount
On November 5, 2025, CMS published the CY 2026 Physician Fee Schedule Final Rule (Final Rule), which includes changes to how drug manufacturers must treat Bona Fide Service Fees (BFSFs) in the context of Average Sales Price (ASP) submissions. In the Final Rule, CMS opted not to finalize its proposal to modify the BFSF definition to require fair market value (FMV) methodology standards, FMV reassessments, and independent third-party valuations. This is a notable departure from the proposed rule, which we covered in a prior blog post. However, CMS is moving forward with several important provisions that impact how manufacturers and other stakeholders document and report BFSFs when calculating ASP for Medicare Part B drugs. This update highlights the finalized requirements that stakeholders should now prepare to implement effective January 1, 2026.
Understanding California SB-41: What PBMs Operating in California Need to Know
October 17, 2025 | Blog | By Theresa Carnegie, Hassan Shaikh, Grace Callander
On October 11, 2025, California Governor Gavin Newsom signed Senate Bill 41 (SB-41) into law, introducing a comprehensive set of new regulations for pharmacy benefit managers (PBMs) operating in the state. As part of the broader California Prescription Drug Affordability legislative package, SB-41 reflects the state’s effort to combat high drug costs, standardize PBM pricing practices, enhance transparency, and address concerns around access to pharmacies. Among other things, SB-41 imposes fiduciary obligations on PBMs, establishes fee structure requirements and limitations, prohibits the use of spread pricing and steering to PBM-affiliated pharmacies, and requires 100% passthrough of rebates from PBMs and their affiliates and contracted rebate group purchasing organizations (GPOs) to health plan customers.
A Pivotal Week for Pharmaceutical Policy: Trump Administration Advances Tariff and Drug Pricing Initiatives
October 7, 2025 | Blog | By Theresa Carnegie, Stephnie John, Hassan Shaikh, Attiya S. Khan, Grace Callander, Sneha Shenoy
The first week of October 2025 marked a significant shift in U.S. drug pricing policy as the Trump administration unveiled a series of sweeping actions to deliver on his promise to lower drug prices. From President Trump’s announcement of a 100% tariff on imported branded drugs to the Trump administration’s landmark pricing deal with Pfizer and the rollout of the TrumpRx.gov direct-to-consumer (DTC) platform, last week marked an escalation in the White House’s efforts to drive down prescription drug costs and bring pharmaceutical manufacturing back to U.S. soil. Below, we provide an overview of the Trump administration’s new policies and the stakeholder responses already reshaping the broader pharmaceutical landscape.
Mintz IRA Update — Disrupting the Pharmaceutical Supply Chain: The Era of the DTC Model
September 15, 2025 | Article | By Theresa Carnegie, Stephnie John
While the pharmaceutical industry has reacted negatively to President Trump’s May 12 “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients” Executive Order (Executive Order), manufacturers appear to be leveraging one of Trump’s directives in the Executive Order, accelerating the industry’s shift toward a new model of drug delivery: direct-to-consumer (DTC) programs.
News & Press
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.
PBMs Enter New Era of Legal Scrutiny
February 10, 2026
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.
Legal Risks Complicate Drugmakers' TrumpRx Participation
February 3, 2026
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.
Transparency, New Players Shake up PBM Landscape
September 11, 2025
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.
Pharma’s Fight Against IRA ‘Will Not Relent,’ as Industry Looks to Supreme Court and Lobbies for Changes
August 14, 2025
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.
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."
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.
States Become More Aggressive with PBM Reform
May 30, 2025
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.
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.
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.
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 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."
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
Executive Orders Targeting Prescription Drug Prices: Agency Objectives, Healthcare Industry Impact, Compliance Issues
Strafford Webinar
Virtual
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 - 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
Recent Insights
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.
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.
