Kate Brinkley-Talley focuses on advising clients on compliance with statutory and regulatory requirements, especially the federal and state health care fraud and abuse laws (e.g., the Anti-Kickback Statute, the Civil Monetary Penalties law, the "Stark" physician self-referral law, and the False Claims Act), Medicare and Medicaid coverage and reimbursement, licensing and credentialing, drug price reporting obligations (e.g., under the 340B program, the Medicaid Drug Rebate Program, and Medicare Part B), participation in Medicare/Medicaid and other federal health care programs, and health information privacy and security (HIPAA and state privacy laws).

Ms. Brinkley-Talley uses her knowledge of the law to counsel clients on legal risks associated with proposed business arrangements. To this end, she regularly drafts and negotiates agreements between pharmaceutical manufacturers and supply chain customers (e.g., PBMs, MCOs, GPOs, specialty pharmacies, wholesale distributors, etc.), develops and reviews compliance policies and procedures, and provides regulatory review for due diligence matters in connection with mergers and acquisitions involving regulated businesses. Ms. Brinkley-Talley has helped clients to navigate government audits and investigations, and also to conduct internal investigations and compliance audits. In addition, she has experience drafting OIG advisory opinion requests, developing CMMI proposals, and advising clients on innovative approaches to health care payment and delivery.

The public policy component of Ms. Brinkley-Talley's practice involves representing and counseling clients in connection with administrative and legislative advocacy, including drafting public comments on agency rules and guidance, drafting proposed legislation, and developing and implementing legislative and regulatory strategies for clients and coalitions seeking public policy solutions.