CATHERINE STARKS, provides strategic regulatory counseling for life sciences, medical technology, health technology, and provider industries. Her client base includes 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 healthcare and life sciences companies on a broad range of healthcare matters, including fraud and abuse risks, coverage and reimbursement, government price reporting, healthcare compliance, drug pricing and rebate reform, 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.
Examples of recent engagements include:
- 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 potential applicability of the Sunshine Act to various payments by pharmaceutical and medical device manufacturers, including those with complex corporate structures; and
- Provide counseling on HIPAA and HITECH implementation and compliance issues for life sciences and digital health companies.