Federal and state regulators have identified many goals for the US health care system: quality care, patient confidentiality, cost efficiency and accountability, among others. Pursuit of these goals by providers requires navigating today’s demanding health care regulatory environment, which involves a staggering sea of laws, regulations and agency guidance that can cause confusion—at best—and at worst will expose industry participants to a storm of significant financial risk, government scrutiny and adverse publicity.

Our experienced health care regulatory lawyers actively assist hospitals, health systems, academic medical centers, multispecialty groups, pharmacies and other health care providers to identify and understand federal and state regulations governing health care operations. We work closely with clients to establish and implement effective policies and processes to address fraud and abuse risks and enhance regulatory compliance, whether in the course of undertaking day-to-day operations or exploring strategic transactions.

When disputes with regulators or law enforcement officials arise, our experienced litigators—including our top-ranked white-collar defense and internal investigations team—rise to the occasion, working with our health care subject-matter experts to help clients conduct internal investigations, cooperate with agency audits, respond to investigations and, when necessary, defend their interests in court.

We assist clients in three key areas:

• Stark and anti-kickback statute compliance, including:
  • Transactions and physician compensation arrangements
  • Joint ventures among providers
  • Obtaining CMS guidance and advisory opinions
• Compliance programs and billing issues, including:
  • Development of compliance program policies
  • Internal investigations and audits
  • Voluntary disclosures under CMS and OIG protocols
  • Voluntary disclosures to Medicare administrative contractors and US Attorney and State Attorney General offices
• Licensure, provider enrollment and reimbursement, including:
  • Facility licensure and certification
  • Medicare and Medicaid enrollment and change of ownership issues
  • Medicare conditions of participation
  • Medicare provider-based billing rules
  • Medicare physician billing rules (Stark and anti-markup)

Our successful record in these areas is attributable to not only our knowledge of regulatory issues but also our focus on developing close working relationships with our clients. Coupled with our firsthand knowledge of their businesses and key objectives, our experience enables us to staff matters cost-effectively and deliver workable solutions. We consider it our responsibility to proactively guide our clients in a manner that mitigates the risks of regulatory noncompliance, whether through appropriately structuring an arrangement on the front end to avoid those potential risks or by proactively investigating and analyzing an existing arrangement to develop the most effective and cost-efficient strategy to resolve any potential noncompliance.