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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

Telepharmacy

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 telepharmacy 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)
  • 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

  • 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

Viewpoints

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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). 
Read more
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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, Michelle Caton

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, Michelle Caton

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.
Read more
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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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CMS Releases Several Stark Law Waivers for Use during the COVID-19 National Emergency

April 1, 2020 | Blog | By Theresa Carnegie, Rachel Yount

On March 30, 2020, the Centers for Medicare & Medicaid Services (CMS) issued blanket waivers to the Stark Law that permit certain arrangements between physicians and health care providers implemented in response to COVID-19 that would otherwise violate the Stark Law. The waivers, which are numerous and fairly broad, offer health care entities significant flexibility to combat COVID-19 in ways that may have otherwise violated the Stark Law, such as the ability to pay physicians hazard pay and provide personal protective equipment to physicians at a price that is below fair market value (FMV). Importantly, the waivers only apply to remuneration and referrals related to COVID-19 purposes.
Read more
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HHS Proposed Changes to AKS and Stark Law: Value-Based Arrangements

February 20, 2020 | Video | By Theresa Carnegie

Theresa Carnegie reviews both the OIG’s and the CMS’s proposed rules as they relate to the new value-based arrangements safe harbors and Stark Law exceptions.
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HHS Proposed Changes to Anti-Kickback Statute and Stark Law

February 10, 2020 | Video | By Karen Lovitch, Theresa Carnegie

Karen Lovitch, Chair of Mintz's Health Law Practice, and Theresa Carnegie, a Member in the Health Law Practice, discuss the proposed changes to the Anti-Kickback Statute (AKS) and Stark Law issued by Department of Health & Human Services (HHS) and dive into some of the key issues.
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This post is the third installment of our blog series on recent proposed rules from the Department of Health & Human Services (HHS) that, if finalized, would implement major changes to the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (commonly known as the Stark Law). Below is an in-depth summary of the Office of Inspector General’s (OIG) proposed modifications to the safe harbors for personal services and management contracts, which includes a proposed new provision protecting outcomes-based payments. We also cover the OIG’s proposed modifications to the warranties safe harbor.
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Doctor Using Calculator

HHS Proposes Sweeping Changes to AKS and Stark Law, Part 2: Cybersecurity Technology and Electronic Health Records

October 21, 2019 | Blog | By Karen Lovitch, Dianne Bourque, Theresa Carnegie, Rachel Yount

On October 17, 2019, the Department of Health & Human Services published two proposed rules that, if finalized, would implement significant changes to the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (commonly known as the Stark Law). This post is the latest installment in our blog series covering these proposed rules.
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HHS Proposes Sweeping Changes to AKS and Stark Law, Part 1: Value-Based Arrangements

October 15, 2019 | Blog | By Theresa Carnegie, Michelle Caton

As we reported last week, the Department of Health & Human Services (HHS) recently issued two proposed rules (one by the Office of Inspector General (OIG) and one by the Centers for Medicare & Medicaid Services (CMS)) that, if finalized, would implement sweeping changes to the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (commonly known as the Stark Law). The proposed rules seek to reduce barriers to value-based contracting in several ways, including: (1) creating new safe harbors to the AKS; (2) adding new exceptions to the Stark Law; and (3) retooling existing AKS safe harbors, along with the Civil Monetary Penalties rules regarding beneficiary inducements. Below are key takeaways from both the OIG’s and the CMS’s proposed rules as they relate to the new value-based arrangements safe harbors and Stark Law exceptions.
Read more

News & Press

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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.”

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

Speaker
Moderator
Chair
Speaker
Nov
13
2017

Pharmacy Benefits and Pharmaceuticals: State of the Industry Update

AHLA

Marriott Chicago Downtown, Magnificent Mile, Chicago, IL

Moderator
Panelist
Speaker
Speaker
Nov
12
2015

4th Annual Pharmacy Benefit Oversight & Compliance Conference

CBI

16770 North Perimeter Drive Scottsdale, AZ