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Healthcare Regulatory & Compliance

The healthcare sector is highly regulated and it’s imperative that providers keep in step with its always evolving and often complex landscape of regulatory and compliance challenges. Greenbaum’s healthcare law practice is at the forefront of advising healthcare entities and professionals across the full spectrum of regulatory and compliance issues, providing strategic counsel and practical solutions to a diverse range of clients including hospitals and health systems, physician practices and individual practitioners, ambulatory surgery centers, long-term care and nursing facilities, pharmacies, medical device and pharmaceutical firms, private equity funds, and healthcare technology companies.

Our team provides comprehensive regulatory counseling services, including compliance guidance related to issues arising under federal Stark Law, federal and state anti-kickback laws, and self-referral laws. We assist clients with federal and state regulatory approvals, provide counsel on the impact of regulatory requirements on healthcare transactions, and represent clients in fraud and abuse defense matters, including government investigations, audits, and enforcement actions related to alleged regulatory compliance violations. Our work also encompasses state licensure and certificate of need issues, state Attorney General, cy pres and Community Health Care Assets Protection Act (CHAPA) approvals, IRS exempt organization applications, antitrust counseling and Hart-Scott-Rodino pre-merger filings with the Federal Trade Commissions (FTC), Health Insurance Portability and Accountability Act (HIPAA), and Health Information Technology for Economic and Clinical Health (HITECH) Act compliance matters, and fraud and abuse counseling.

In addition, we navigate clients through New Jersey’s strict corporate practice of medicine (CPOM) doctrine, which governs how physician practices can be owned, operated, and/or managed in the state.

Representative Matters

  • Advising a New Jersey-based ABA therapy organization in responding to a New Jersey Medicaid Fraud Division (MFD) audit. This matter includes counseling the client on the MFD interview process, assisting in providing relevant documentation responsive to the audit, and advising the client on compliance with follow-up requests from the MFD in anticipation of an eventual resolution of the audit, including any repayment demands.
  • Serving as outside regulatory counsel to a multispecialty provider of healthcare services, leading internal investigations and compliance reviews in response to federal scrutiny of physician billing practices, including platelet-rich plasma therapy and “incident-to” billing, and guiding corrective action to mitigate fraud-and-abuse exposure and protect Medicare participation.
  • Guiding an outpatient psychiatry practice through Medicare and Medicaid compliance remediation, addressing opted-out Medicare billing issues and regulatory inquiries to preserve continued operations and avoid enforcement action.
  • Serving as outside general counsel to a large orthopedic surgical practice, advising on healthcare compliance, employment, corporate, and payor disputes, and securing regulatory relief that corrected systemic claims-processing errors and restored practice cash flow.
  • Advised a healthcare company and its principals on regulatory and criminal compliance issues, including anti-kickback statute considerations, in connection with the launch of a competing healthcare business following the departure of an executive from a prior employer.  
  • Represented a global pharmaceutical company in successfully petitioning the New Jersey Supreme Court for special in-house licensure, enabling out-of-state counsel to practice in New Jersey on a permanent basis.
  • Represented a real estate company as healthcare and regulatory counsel in developing assisted living facilities in Scotch Plains, East Brunswick, and Old Tappan in transactions exceeding $10 million.
  • Represented a private investment fund in a CPA firm’s acquisition of a medical coding company, navigating complex cross-border regulatory requirements involving India-based ownership.  
  • Represented a global pharmaceutical company in successfully petitioning the New Jersey Supreme Court for special in-house licensure, enabling out-of-state counsel to practice in New Jersey on a permanent basis.

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