Bryan Cave has extensive experience assisting clients in navigating the complex health care regulatory and compliance issues facing their organizations, including providers such as hospitals and health systems, ambulatory surgery centers, diagnostic imaging centers, clinical laboratories, skilled nursing and assisted living or retirement centers, and home health providers. We advise clients on such matters as compliance with federal and state fraud and abuse laws, including the Anti-Kickback Statute, Civil Monetary Penalties Law, Stark Law self-referral prohibition and False Claims Act, both on the organizational level as well as for physicians and health care executives evaluating compensation structures for clinical, medical director and administrative services. In the unfortunate circumstance that one of our clients is subject to an investigation by the Office of Inspector General or Department of Justice, our health care attorneys work seamlessly with Bryan Cave’s Litigation & White Collar Defense Team in responding to these and other governmental agency investigations and potential whistleblower (qui tam) suits.
In addition to advising health care organizations on fraud and abuse-related compliance matters, Bryan Cave’s attorneys regularly advise clients regarding compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Health Information Technology for Economic and Clinical Health Act. Compliance with the numerous requirements mandated by these acts and the related privacy and security rules may take the form of drafting and negotiating business associate agreements (BAAs); preparing security risk assessments; assisting covered entities and business associates in drafting internal policies and procedures related to personal health information security processes in the event of a security incident or breach; as well as data retention and record management manuals. We also assist organizations in responding to HIPAA compliance audits conducted by the Centers for Medicare & Medicaid Services (CMS) and the Department of Health & Human Services (HHS).
Other regulatory compliance matters with which Bryan Cave’s attorneys have significant experience include: Medicare, Medicaid, and other federal program billing and reimbursement compliance for both traditional fee-for-service models and alternative value-based reimbursement models; Physician Payment Sunshine Act reporting; state fee-splitting statutes; federal and state telemedicine and provider scope of practice compliance; Certificate of Need requirements; and other provider and organizational licensing and accreditation requirements.