Claire E. Castles

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.