CATHERINE STARKS, an associate in the firm’s Healthcare practice, focuses on regulatory counseling and compliance matters for a variety of life science companies, including pharmaceutical manufacturers, rare disease companies, medical device companies, and healthcare and digital health companies. Catherine advises clients on a wide range of healthcare regulatory matters, including Federal Anti-Kickback Statute compliance; government price reporting for pharmaceutical products; managed care contracting and patient access issues; Federal healthcare program coverage and reimbursement; HIPAA and HITECH implementation and compliance; healthcare compliance programs, including drafting policies and procedures, counseling on implementation issues, and conducting audits and internal reviews; and reporting under the Sunshine Act and analogous state laws.
Examples of recent engagements include:
- Day-to-day counseling to several pharmaceutical manufacturers with respect to their managed care contracting practices, including advising on potential fraud and abuse risks and impact on government price reporting;
- Regulatory counseling to several pharmaceutical manufacturers with respect to their patient access programs, including free drug programs, co-payment support, reimbursement support, and donations to independent third-party charitable patient assistance foundations;
- Ongoing strategic counseling to manufacturers of rare disease products;
- Advice to a pharmaceutical manufacturer on the commercial, price reporting, and other regulatory implications stemming from product discontinuation;
- Day-to-day counseling to several medical device manufacturers on fraud and abuse issues, including analyzing discount, rebate, and other arrangements with customers and conducting internal training;
- Counsel to pharmaceutical manufacturers in designing, implementing, and reviewing corporate compliance programs;
- Preparation of memoranda and other analyses regarding the potential applicability of the Sunshine Act to various pharmaceutical manufacturers, including those with complex corporate structures; and
- Preparation of memoranda and other analyses for digital health companies regarding privacy and security obligations under HIPAA and HITECH.