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
Biden Administration Takes Aim at Rising Drug Prices through its Executive Order on Promoting Competition
July 20, 2021 | Blog | By Theresa Carnegie, Lauren Moldawer
On Friday, July 9th, President Biden released an Executive Order “to promote competition in the American economy” and to “to reduce the trend of corporate consolidation” (the “Order”). As part of this Order, the Biden Administration specifically targets competition in the pharmaceutical industry and sets forth policies to combat the high cost of prescription drugs. As the Administration’s first major policy initiative on drug pricing, this Order may serve as a preview of the Administration’s drug pricing reform agenda. For additional information about the Executive Order, please see our Antitrust colleagues' alert on the Order's initiatives specifically earmarked for the Federal Trade Commission and the Department of Justice’s Antitrust Division.
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Fourth Time’s the Charm? How COVID-19 May Spur Congress to Pass Legislation Expanding Coverage for Pharmacist Services
May 12, 2021 | Blog | By Hassan Shaikh, Theresa Carnegie
On April 22, 2021, Reps. G.K. Butterfield (D-NC) and David McKinley (R-WV) introduced H.R. 2759, or the Pharmacy and Medically Underserved Areas Enhancement Act. Its introduction marks a fourth bipartisan effort in the House to enact the legislation, which would allow Medicare to directly reimburse pharmacists for delivering certain health care services to Medicare beneficiaries living in areas with limited access to primary medical care. Hindsight suggests that when introduced in the past, the Act may not have been ripe for consideration. But now, in the wake of the COVID-19 pandemic and on the heels of successful initiatives like the West Virginia vaccine rollout, Congress may not wish to table discussion of the legislation any longer.
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The American Families Plan & A Call for Drug Pricing Legislation
May 10, 2021 | Blog | By Theresa Carnegie, Cody Keetch
On April 28, 2021, President Biden gave his first address to Congress and announced the American Families Plan (AFP). The AFP follows the 1.9 trillion-dollar stimulus, the American Rescue Plan Act, signed into law on March 11, 2021. Notably, in his speech, President Biden called upon Congress to pass drug pricing legislation; however, the current White House Fact Sheet on the AFP does not include specific drug pricing provisions. This blog post discusses the health-related portions of the AFP and provides an overview of the Lower Drug Costs Now Act which seeks to lower prescription drug prices.
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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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Trump Signs Executive Orders Aimed at Tying Domestic Drug Prices to Foreign Prices
September 15, 2020 | Blog | By Theresa Carnegie
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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CMS Proposes Rule to Pave the Way for Value-Based Drug Purchasing
June 26, 2020 | Blog | By Theresa Carnegie
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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Massive House Bill Proposes Mandatory Coverage of COVID-19 Vaccines and Therapies
May 18, 2020 | Blog | By Theresa Carnegie
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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Four Things to Know About Trump’s Executive Order on Hoarding of PPE
April 15, 2020 | Blog | By Theresa Carnegie
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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News & Press
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
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.
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 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
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 & Speaking
Speaker
May
20
2024
Breaking Up is Hard to do and Other Trends in PBM and Pharmacy Supply Chain Contracting
BCBS 2024 Law, Audit, Compliance & Ethics Conference
Nashville, TN
Speaker
Jun
29
2020
Examining the Impact of COVID-19 on Pharmacy Benefits and the Pharmaceutical Supply Chain
American Health Law Association Annual Meeting
Online Event
Speaker
May
2
2019
4th Annual Mintz /ML Strategies Pharmacy & Pharmaceutical Industry Summit
Mintz and ML Strategies
Boston, MA
Chair
May
8
2018
3rd Annual Mintz /ML Strategies Pharmacy & Pharmaceutical Industry Summit
Mintz and ML Strategies
Boston, MA
Moderator
May
8
2018
3rd Annual Mintz /ML Strategies Pharmacy & Pharmaceutical Industry Summit
Mintz and ML Strategies
Boston, MA
Speaker
Nov
13
2017
Pharmacy Benefits and Pharmaceuticals: State of the Industry Update
AHLA
Marriott Chicago Downtown, Magnificent Mile, Chicago, IL
Panelist
Panelist
Moderator
Speaker
Speaker
Panelist
Speaker
Nov
12
2015
4th Annual Pharmacy Benefit Oversight & Compliance Conference
CBI
16770 North Perimeter Drive Scottsdale, AZ
Panelist
Read less
Aug
5
2015
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)
Nightingale’s Healthcare News: Outstanding Young Healthcare Lawyers (2005)
Phi Beta Kappa
Recent Insights
PBM Policy and Legislative Update — Winter 2024
April 9, 2024| Blog|
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.
