Catherine Starks

Practice Areas

CATHERINE STARKS represents life sciences and healthcare companies in strategic commercial and mission-critical regulatory matters. Her clients include global pharmaceutical and medical device manufacturers, cell and gene therapy companies, clinical stage development companies, rare disease companies, digital health companies, distributors, healthcare providers, and private equity firms focused on healthcare. Catherine counsels on a broad range of complex and strategic healthcare matters, including drug pricing reforms under the Inflation Reduction Act, digital health offerings, fraud and abuse risks, coverage and reimbursement, government price reporting, market access strategies, outcomes-based arrangements, and other novel payment and access models. She has represented several clients in mission-critical matters before key regulatory agencies, including the Centers for Medicare & Medicaid Services; the Department of Health and Human Services, Office of Inspector General; and numerous state healthcare agencies. Catherine also counsels on healthcare compliance, patient assistance programs, regulatory due diligence, licensure matters, patient privacy, and reporting under the Sunshine Act and analogous state laws.