Cate Brandon's practice focuses on the intersection of healthcare law and policy. Ms. Brandon 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. Ms. Brandon's work includes advising pharmaceutical companies and healthcare providers on matters related to healthcare fraud and abuse compliance, including anti-kickback laws and the "Stark" physician self-referral law; Medicare and Medicaid reimbursement and related policies, including the Inflation Reduction Act; the Patient Protection and Affordable Care Act (ACA); the No Surprises Act; and other regulatory and legislative initiatives affecting the life sciences and healthcare industries. Ms. Brandon has particular experience advising clients on patient support programs, contractual arrangements, value-based arrangements and reimbursement, digital health initiatives, and industry collaborations.
As part of her practice, Ms. Brandon regularly represents clients in Congressional, criminal and civil investigations brought by the federal government, as well as conducts internal investigations.
From 2015-2016, Ms. Brandon served as Senior Counsel on Oversight at the US 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 and Medicaid Services, including ACA implementation, as well as other HHS programs.
Ms. Brandon graduated cum laude from the University of Pennsylvania Law School where she served as an Associate Editor for the University of Pennsylvania Law Review. Prior to attending law school, Ms. Brandon worked for various public policy organizations providing communications and public affairs counsel.
- Representing major biopharmaceutical company in multiple Congressional inquiries related to drug pricing.
- Represented major pharmaceutical 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.
- Represented 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.
- Conducted internal compliance investigations at multiple major biopharmaceutical companies into alleged violations of companies' compliance policies.
- Led cross-practice team of A&P attorneys in advising affiliated life sciences companies on an innovative research and data collaboration with a practice management company and its affiliated physician practices.
- 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, and arrangements with healthcare providers.
- 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.
- Represented multiple healthcare and life sciences clients requesting advisory opinions from the HHS Office of the Inspector General (OIG) regarding novel patient support arrangements.
- Assisted major pharmaceutical company with a comprehensive review and enhancement of its policies and procedures related to patient support activities.
- Conducted several risk assessments of the market access and patient support activities at several major biopharmaceutical companies, culminating in reports providing compliance recommendations for the business and executive leadership.
- Regularly assisting several biopharmaceutical companies, physician specialty societies, and trade organizations in developing strategic positions, and drafting related comment letters, regarding CMS and HHS OIG proposed rulemaking.
- Advising physician practices regarding compliance with Medicare's Quality Payment Program.
- JD, University of Pennsylvania Law School, 2009,
- AB, Brown University, 2004,
magna cum laude
- District of Columbia
- New York
Senior Counsel on Oversight, Office of the Assistant Secretary for Legislation, HHS