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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.

Education

  • Duke University (JD, summa cum laude)
  • Bowdoin College (BA)

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.

Recognition & Awards

  • BTI Consulting Group: Client Service All-Star (2020)
  • Chambers USA: District of Columbia (Up and Coming) – Healthcare (2014, 2015)
  • Nightingale’s Healthcare News: Outstanding Young Healthcare Lawyers (2005)
  • Phi Beta Kappa

Languages

- Spanish

Recent Insights

News & Press

Events

Viewpoints

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Biden Administration’s Drug Pricing Plan Calls for Bold Action by Congress

September 10, 2021 | Blog | By Joanne Hawana, Theresa Carnegie, Lauren Moldawer

It’s finally here – the Drug Pricing Plan that President Biden ordered the Department of Health and Human Services (HHS) to produce by the end of August (the “Plan”) was released publicly by the Administration on September 9, 2021. The Plan makes it clear that the Biden Administration supports aggressive action to address rising drug prices, including controversial actions such as allowing HHS to negotiate the cost of Medicare Part B and D drugs. The Plan also outlines a set of administrative actions that HHS and its operating agencies can take, without the need for intervention by Congress. A notable gap in the Plan, however, is the Administration’s potential approach to manufacturer rebates and the Rebate Rule.
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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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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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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, Ellyn Sternfield

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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News & Press

News Thumbnail
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.
Press Release Thumbnail
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.”

Events

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

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Nov
13
2017

Pharmacy Benefits and Pharmaceuticals: State of the Industry Update

AHLA

Marriott Chicago Downtown, Magnificent Mile, Chicago, IL

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Nov
12
2015

4th Annual Pharmacy Benefit Oversight & Compliance Conference

CBI

16770 North Perimeter Drive Scottsdale, AZ