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Theresa C. Carnegie

Member

[email protected]

+1.202.661.8710

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Theresa counsels health care clients on a variety of transactional, regulatory, and fraud and abuse matters.

Theresa focuses much of her practice on counseling health plans, pharmacy benefit managers, pharmacies, device manufacturers, and distributors on regulatory and compliance matters. Her practice extends to counseling on drug pricing and reimbursement issues, Medicare Advantage and Medicare Part D compliance, and the regulatory requirements under the Affordable Care Act and state health insurance exchanges. Theresa has extensive experience drafting, negotiating, and structuring PBM agreements, retail, mail and specialty pharmacy agreements, GPO agreements, and pharmaceutical purchase, distribution, and rebate agreements. She also regularly counsels these clients on compliance with federal and state fraud and abuse laws, the PhRMA and AdvaMed Codes, state disclosure and gift ban laws, and state licensure laws.

Theresa also specializes in representing clients in connection with mergers and acquisitions, joint ventures, strategic affiliations, complex service agreements, provider contracts, network development programs, and general contracting. Theresa advises clients on the structuring and legal, practical, and fraud and abuse implications of these business arrangements and transactions. She has served as health regulatory counsel on managed care, PBM, pharmacy, laboratory, behavioral health, anesthesiology, DME, and practice management company transactions. Theresa also has deep experience assisting private equity firms in connection with their investment in the health care industry and the day-to-day regulatory compliance of their portfolio companies.

Other aspects of Theresa’s practice include day-to-day counseling on matters related to the anti-kickback statute, the Stark law, and state statutes prohibiting kickbacks and self-referrals. Theresa regularly advises clients on the structuring of business arrangements to comply with state regulatory restrictions such as corporate practice of medicine and fee-splitting prohibitions. Theresa is also an Editor of and a frequent contributor to Mintz's Health Law blog, Health Law & Policy Matters.

Education

  • Duke University (JD)
  • Bowdoin College (BA)

Experience

  • 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.
  • Represented a national specialty pharmacy provider in connection with an internal investigation and audit of various compliance practices, as well as assistance with a response to a government investigation.

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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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.
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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.
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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.
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HHS Proposes Sweeping Changes to Anti-Kickback Statute and Stark Law

October 10, 2019 | Blog | By Karen Lovitch, Theresa Carnegie, Rachel Yount

On October 9, 2019, the Department of Health & Human Services (HHS) announced significant changes to the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (known as the Stark Law) through proposed rules issued by the Office of Inspector General (OIG) and the Centers for Medicare & Medicaid Services (CMS). The proposed rules are part of HHS’s Regulatory Sprint to Coordinated Care, which aims to promote value-based care and ease regulatory burden on health care providers, particularly with respect to the AKS and the Stark Law.
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Senate Finance Committee Passes Drug Pricing Bill

July 30, 2019 | Blog | By Theresa Carnegie, Ellyn Sternfield, Michelle Caton

Senators Chuck Grassley (R-IA) and Ron Wyden (D-OR), Chairman and Ranking Member (respectively) of the Senate Finance Committee, have fired the latest shot in Congress’s ongoing battle against high drug prices. Last week, the Senators introduced their much-anticipated proposal to lower drug prices: a chairman’s mark called the Prescription Drug Pricing Reduction Act (PDPRA) of 2019.

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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

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