Healthcare Regulatory Compliance

Rx for Success

Understanding the complex web of regulatory requirements placed upon healthcare providers, practitioners, payers, and suppliers is a cornerstone of any healthcare practice, Blank Rome’s attorneys have been at the forefront of these activities and have represented clients in:

  • structuring of arrangements for compliance with the Stark Law, the federal Anti-kickback Statute, and the federal False Claims Act (and similar state law prohibitions)
  • compliance with increasingly complex healthcare privacy and security requirements, including matters for European Union and United States based multi-national corporations
  • provider (institutional) and supplier (individual) licensing activities
  • agency hearings, medical board inquiries and tribunal representation
  • prepayment and post payment audits and investigations before federal and state regulatory agencies, Medicare Administrative Contractors, and other government auditors and contractors such as program safeguard or integrity contractors
  • drafting comprehensive compliance policies and guidance documents
  • clinical research compliance, including informed consent documents and  storage and use of human biological samples.

Drawing on substantial government and industry experience, our team of healthcare and litigation attorneys works with our government relations professionals and are nationally recognized in providing compliance and enforcement representation to healthcare providers and companies in federal and state healthcare matters.

The regulatory team regularly interacts with various state and federal agencies such as the U.S. Department of Health and Human Services (HHS), including its principal operating components, the Centers for Medicare and Medicaid Services (CMS), the Office of Inspector General (OIG), the Food and Drug Administration (FDA), and the components that comprise the Secretary’s Office, such as the Office of General Counsel. Our regulatory team works alongside our government relations professionals and other attorneys to assist clients in developing strategies to both solve today’s regulatory problems and preserve relationships necessary to continue to do business with strategic government partners in the future.