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Theresa C. Carnegie

Member

[email protected]

+1.202.661.8710

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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.
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viewpoints

As we wrote about in our prior blog post, on September 29, 2023, John D. Bates of the U.S. District Court for the District of Columbia struck down a federal rule that permitted health plans and pharmacy benefit managers (PBMs) to exclude drug manufacturer copayment (copay) assistance from a patient’s cost sharing limits. In two separate filings this week, HHS signaled that it intends to support the continued use of copay accumulator programs as the industry has been using them since 2021.
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In a significant development with far-reaching implications for health plans and pharmacy benefit managers (“PBMs”), Justice John D. Bates of the U.S. District Court for the District of Columbia has recently struck down a federal rule that allowed health plans to use copay accumulator programs to exclude drug manufacturer copay assistance from a patient’s out-of-pocket costs. This ruling has significant implications for the way health plans and PBMs operate and interact with patients and copay assistance programs.
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MintzRx is a regular newsletter providing you with everything you need to know to stay abreast of the legal, regulatory, and industry developments across the pharmaceutical supply chain.
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The Office of Inspector General for the Department of Health and Human Services (OIG) recently published an Advisory Opinion in which it concluded that the provision of free genetic testing and counseling services by a pharmaceutical manufacturer would not result in the imposition of sanctions under the federal Anti-Kickback Statute (AKS) and the beneficiary inducements civil monetary penalty provision (Beneficiary Inducements CMP).  This Advisory Opinion is the first to address this type of arrangement and thus provides useful insight for the health care and life sciences industries.
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News & Press

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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 Carnegie, Lauren 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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Events & Speaking

Speaker
Jun
29
2020
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Chair
Moderator
Speaker
Nov
13
2017

Pharmacy Benefits and Pharmaceuticals: State of the Industry Update

AHLA

Marriott Chicago Downtown, Magnificent Mile, Chicago, IL

Moderator
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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)

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

  • Phi Beta Kappa

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