Claire Castles advises clients on complex health care and life science regulatory compliance issues in transactions, investigations, and litigation matters, including issues that are international in scope, relate to significant regulatory enforcement, and present potential reputational concerns.
Claire helps clients implement response strategies for novel and emerging public health threats, including COVID-19. She assists clients in regulatory waiver strategies and impact on corporate practice of medicine, HIPAA/HITECH, and other state and federal regulations and guidance. Claire assisted clients in obtaining first-of-its-kind "hospital without walls" waivers from CMS (Centers for Medicare & Medicaid Services). She also advises clients on health reform strategies that include assistance with CMMI (Center for Medicare and Medicaid Innovation) pilot program participation and value-based and risk-based payment arrangements. Claire also assists clients in assessing hospital closure issues and distressed hospital strategies.
Claire works with clients to implement strategic practices advancing regulatory compliance related to Medicare and Medicaid, payment reform, graduate medical education programs, clinical trials, 340B and Medicaid Drug Rebate programs, and drug and device coverage and reimbursement. She advises clients in operational and administrative responses to licensing, survey, and audit findings, including immediate jeopardy, health privacy allegations, CMS suspension and termination, and state and federal Office of Inspector General investigations and disclosures. Claire also assists with repayments and remediation strategies to private payors and state and federal agencies, including the Medicare and Medicaid program.
Claire is a voting member of the National Native American Bar Association and Fellow of the American Bar Foundation.
担当案件
- September 14, 2017
Trends in Clinical Trials, Regulatory Risks and Strategies for Commercialization, Fourth Annual ABA Life Sciences Legal Summitt - April 24, 2017
Planning for MACRA, Health Reform, and Reimbursement Changes - July 26, 2016
CMS 60-Day Rule (Intermediate), AHLA Distance Learning Series - May 21, 2014
Responding to Licensing and Certification Deficiencies, California Hospital Association - April 17, 2014
Increased Focus on Enforcement in Clinical Research - Lessons from Recent Cases, San Diego Regulatory Affairs Network - February 2013
Healthcare Data Security: Practical Tips For Managing Risk From Legal and Enforcement Perspective, ABA Emerging Issues Conference - October 17, 2012
Jones Day / Navigant 16th Annual Health Care Compliance Forum - June 18, 2012
Lessons Learned: What Providers and ACOs Looking to Participate in 2013 Should Anticipate, AHLA Webinar - March 1, 2012
AHLA Healthcare Fraud and Abuse Bootcamp Webinar Series, Part III: The Federal Anti-Kickback Law: An Overview, Recent Enforcement Trends and Impact of Healthcare Reform - October 20, 2011
Payment Reform and Its Implications for Your Health System, 15th Annual Health Care Compliance Forum - 2011
Health Reform - Understanding the Law, University of California Compliance & Audit Symposium - 2010
Understanding POLST Forms, Fresno County Bar Association - 2009, 2008, 2007, 2006
Annual Health Care Fraud and Abuse Education Updates, American Association of Professional Coders, Fresno Chapter - 2009
Medical Identity Theft and Red Flag Rules, Central Valley of California
"She's able to analyze very complex legal questions very efficiently and get to the heart of the issues." "Her advice is insightful and she takes a practical view of things."Chambers USA
- University of Houston Law Center (LL.M. in Health Law 2004); University of Oklahoma (J.D. 2003); University of Central Oklahoma (B.A. 2000)
- California and Cherokee Nation
Recognized in Chambers USA for health care in California (2020-2023)
Recognized by The American Lawyer in its inaugural list of West Trailblazers (2021)
Daily Journal: "Top Health Care Lawyers" in California (2021, 2023)
Los Angeles Business Journal: "Thriving in their 40s" list (2021, 2023)
Recommended lawyer in The Legal 500 US for life sciences and health insurance (2018)
Fellow, American Bar Foundation
"Rising Star," Southern California Super Lawyers (2013 and 2014)