Kate Brinkley-Talley represents and counsels a broad range of health care and life sciences industry clients on regulatory, compliance, enforcement, transactional, and public policy matters.

Ms. Brinkley-Talley focuses on advising clients on compliance with statutory and regulatory requirements, especially the federal and state health care fraud and abuse laws (including 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 considerations, health care licensing and credentialing, drug price reporting obligations (including under the 340B program, the Medicaid Drug Rebate Program, and the Medicare Part B drug price reporting requirements), participation in Medicare/Medicaid and other federal health care programs, health information privacy and security compliance (HIPAA and state privacy laws), and other regulatory and legislative developments affecting the health care industry.

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 clients in connection with administrative and Congressional advocacy. She regularly drafts public comments on proposed rules and guidance issued by CMS and OIG. In addition, she has experience with legislative drafting, and developing and implementing legislative and regulatory strategies for clients and coalitions seeking public policy solutions.

Perspectives

Medicare and FCC Take Additional Steps to Support the Frontline Battling COVID-19
Coronavirus: Life Sciences and Healthcare Regulatory Advisory
Telehealth During COVID-19: New Rules And Considerations
Commercial Contracts Law360, Compliance Law360, Consumer Protection Law360, Cybersecurity & Privacy Law360, Health Law360, Life Sciences Law360, Personal Injury & Medical Malpractice Law360, Public Policy Law360, Technology Law360, Telecommunications Law360
Expanding Telehealth Services to Fight COVID-19
Coronavirus: Life Sciences and Healthcare Regulatory Advisory
HHS Proposes New Protections for Value-Based Arrangements and Other Revisions to AKS Safe Harbors, CMP Exceptions and Stark Exceptions
Advisory
HHS OIG's Proposed Rule Revising the AKS Safe Harbors and Beneficiary Inducement CMP Rules: Information for Drug and Device Manufacturers
Advisory
More

Recognition

Best Lawyers
"Ones to Watch"–Health Care Law (2021)

Credentials

Education
  • JD, The George Washington University Law School, 2013, with Honors
  • Graduate Certificate in Health Policy, The George Washington University School of Public Health & Health Services, 2013
  • BS, Public Health, The George Washington University, 2007, magna cum laude
Admissions
  • District of Columbia
Overview

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