Theresa C. Carnegie

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.

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

• 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