Unwinding Public Health Emergency Mandates and Waivers: Compliance Considerations

Ms. Sullivan chairs the firm’s National Healthcare Practice. She assists clinical laboratories, hospitals, physician specialty groups, surgery centers, pharmacies, and other healthcare providers on regulatory, licensing, compliance, reimbursement, contractual, and corporate matters. She provides support to entities during licensure and accreditation surveys and assists in navigating state professional licensure laws, CLIA standards and state laboratory laws, government and private payor reimbursement, fraud and abuse rules, state telehealth laws, HIPAA rules and regulations, and state and federal pharmacy regulation. 

Ms. Johnson focuses her practice on matters primarily for clients in the healthcare industry. She provides regulatory and compliance assistance on both a federal and state level. She has assisted clinical laboratories, hospitals, long-term acute care hospitals, community hospitals, physician specialty groups, telehealth providers, surgery centers, healthcare associations, pharmacies, and other healthcare providers on regulatory, licensing, compliance, reimbursement, contractual, and corporate matters. Ms. Johnson has provided support to entities during licensure and accreditation surveys and assisted in navigating state professional licensure laws, CLIA standards and state and federal laboratory laws and regulations, government and private payor reimbursement, state and federal fraud and abuse rules, state telehealth laws, and state and federal pharmacy regulation. She also has advised clients on direct to consumer testing issues and applicable state requirements. In addition, Ms. Johnson has significant experience with HIPAA compliance, including drafting HIPAA policies and procedures, breach response and notification, drafting responses to investigations conducted by the Office for Civil Rights, and advising clients on proactive HIPAA compliance and breach prevention.

Ms. 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. She helps clients implement response strategies for novel and emerging public health threats, including COVID-19. She assists clients in developing specialized testing, front line support services, and digital health initiatives, including needed regulatory waiver strategies and impact on corporate practice of medicine, HIPAA/HITECH, and other state and federal regulations and guidance. Ms. Castles 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.

Ms. Culliton represents clients across the healthcare industry in matters relating to regulatory compliance and healthcare litigation and arbitration. She provides analysis regarding regulatory issues and compliance strategies, with an emphasis on pricing and reimbursement considerations, graduate medical education programs, provider-based status and site-neutral reimbursement, and Medicare conditions of participation. She also assists providers in operational and administrative responses to Centers for Medicare & Medicaid Services' survey and deficiency findings, including immediate jeopardy situations, and program integrity functions, including payment suspensions. In addition, her experience includes representing healthcare providers in litigation and arbitration that enables providers to collect proper reimbursement from commercial and government-sponsored payors.