Catherine A. Brandon | People

Cate Brandon's practice focuses on the intersection of healthcare law and policy. Cate counsels life sciences companies, healthcare providers, and related trade and specialty societies on healthcare regulatory, compliance, and enforcement matters, as well as public policy issues. Cate's work includes advising pharmaceutical companies, healthcare providers, and health systems on matters related to healthcare fraud and abuse compliance, including anti-kickback laws and the "Stark" physician self-referral law; pricing and reimbursement and related policies, including most-favored-nation (MFN) pricing initiatives, the Inflation Reduction Act; the Patient Protection and Affordable Care Act (ACA), and the No Surprises Act; and other regulatory and legislative initiatives affecting the life sciences and healthcare industries. Cate has particular experience advising clients on patient support programs, contractual arrangements, value-based arrangements and reimbursement, digital and AI-enabled health initiatives, telehealth arrangements, and life sciences-health system collaborations.

As part of her practice, Cate represents clients in congressional, criminal, and civil investigations brought by the federal government and state attorneys general, as well as conducts internal investigations.

From 2015-2016, Cate served as Senior Counsel on Oversight at the U.S. Department of Health and Human Services (HHS), where she was responsible for developing strategic responses to congressional oversight and investigations for the Office of the Secretary on issues related to the Centers for Medicare & Medicaid Services, including ACA implementation, as well as other HHS programs. Prior to her legal career, Cate worked for various public policy organizations providing communications and public affairs counsel.

She co-chairs the firm's National Hiring Committee.

Focus Areas

Experience

Represented Dr. Francis Collins, former Director of the National Institutes of Health (NIH), in response to requests for documents and testimony from multiple House committees related to the origins of COVID-19.
Representing global biopharmaceutical company in multiple congressional inquiries related to drug pricing, including preparing executives for congressional testimony.
Represented major biopharmaceutical company in multiple congressional inquiries related to COVID-19 vaccine manufacturing.

Represented major biopharmaceutical company in connection with federal civil investigation into donations to independent copay assistance foundations.
Represented a major biopharmaceutical company in connection with a civil investigative demand (CID) related to the company's arrangements with pharmacy benefit managers.
Represent a biopharmaceutical company as settlement counsel in relation to litigation and investigations initiated by state attorneys general regarding drug pricing and PBM contracting practices.
Represented a hospital system in connection with a federal investigation and qui tam action related to the COVID-19 Provider Relief Fund.
Represented a national hospital chain in a federal criminal and civil investigation related to allegations regarding improper billing and arrangements with physicians.

Represented a device manufacturer in connection with self-disclosure of potential licensure non-compliance to CMS and state Medicaid programs and related settlement negotiations.

Advised multiple global biopharmaceutical companies regarding their negotiations with the U.S. government related to most-favored-nation drug pricing and supporting implementation of those arrangements.
Represented multiple healthcare provider and life sciences clients requesting advisory opinions from the HHS Office of the Inspector General (OIG) regarding novel patient support and customer arrangements.
Regularly assisting several biopharmaceutical companies, physician specialty societies, healthcare providers, and trade organizations in developing strategic positions, and drafting related comment letters, regarding CMS and HHS OIG proposed rulemaking.
Regularly advising biopharmaceutical, life sciences, and laboratory companies on regulatory and fraud and abuse considerations in connection with payor and supply chain contracting, pricing strategies, reimbursement and patient support activities, patient financial assistance offerings, field personnel, and arrangements with healthcare providers.
Regularly conducting risk assessments of the market access and patient support activities at biopharmaceutical companies, culminating in reports providing compliance recommendations, including enhancement of their policies and procedures, for legal and executive leadership.

Advising healthcare providers regarding compliance with the No Surprises Act.
Conducted internal compliance investigations at multiple major biopharmaceutical companies into alleged violations of companies' compliance policies.
Led cross-practice team of Arnold & Porter attorneys in advising affiliated life sciences companies on an innovative research and clinico-genomic data collaboration with a practice management company and its affiliated physician practices.
Advising a laboratory company regarding fraud and abuse considerations with respect to research collaborations with health systems and provider groups.
Served on secondment as the sole Market Access attorney for the in-house legal department of a major pharmaceutical manufacturer to counsel business clients regarding pricing and contracting strategy, services arrangements and collaborations, contract negotiations, and reimbursement and patient support offerings.
Assisted multiple life sciences companies in conducting healthcare regulatory due diligence for corporate transactions, with a particular focus on digital health acquisitions.