CATHERINE STARKS represents life sciences and healthcare companies in strategic commercial and regulatory matters. Her clients include pharmaceutical and medical device manufacturers, clinical stage and rare disease companies, digital health companies, healthcare providers, and private equity firms focused on healthcare. She regularly counsels on a broad range of healthcare matters, including the Inflation Reduction Act, fraud and abuse risks, coverage and reimbursement, government price reporting, healthcare compliance, drug rebates, market access, patient assistance programs, value-based arrangements, government advocacy, regulatory due diligence, patient privacy, and reporting under the Sunshine Act and analogous state laws. Catherine is recognized in Chambers USA in the area of Healthcare: Pharmaceutical/Medical Products Regulatory – Illinois (2023).
Examples of recent engagements include:
- Provide strategic counseling to a range of pharmaceutical manufacturers on drug pricing reforms under the Inflation Reduction Act;
- Provide ongoing strategic counseling to clinical stage companies and manufacturers of rare disease products on drug pricing, fraud and abuse compliance, coverage and reimbursement, and market access;
- Provide day-to-day counseling to a range of pharmaceutical manufacturers on managed care contracting practices, including rebate strategies;
- Engage in advocacy efforts with the Centers for Medicare and Medicaid Services (CMS) and the Department of Health and Human Services, Office of Inspector General (OIG) to advance client positions on important policy proposals and regulatory developments;
- Counsel a range of pharmaceutical manufacturers on compliant patient access and support programs, including free drug, co-payment support, and reimbursement support programs, and donations to independent third-party patient assistance foundations;
- Advise on the commercial, price reporting, and other regulatory implications stemming from discontinuation of pharmaceutical products;
- Provide day-to-day counseling to medical device manufacturers on fraud and abuse issues, including analyzing discount, rebate, and other arrangements with customers;
- Advise pharmaceutical and medical device manufacturers on corporate compliance programs, leading compliance program reviews, drafting policies and procedures, and counseling on design and implementation issues;
- Advise on the Physician Payments Sunshine Act, Sunshine Act remediation, and State transparency laws; and
- Provide counseling on HIPAA and HITECH implementation and compliance issues for life sciences and digital health companies.