Navigating the Regulatory and Statutory Landscape

Combating healthcare fraud and abuse has long been a key priority of both the state and federal government. With recent changes to the laws in place, the federal government has instituted new tactics and strategies to fight fraud and abuse in federal health programs. State Medicaid administrators are focusing more on Medicaid fraud. And whistleblower laws make it lucrative for employees and contractors to bring actions on behalf of the government that allege wrongdoing on the part of practitioners and healthcare providers. We meld our extensive experience in healthcare law with our knowledge and understanding of government investigations, including FDA and DEA audits and investigations, and compliance requirements to craft effective solutions for investigations and disclosure issues at all levels.

Support for a Wide Range of Compliance Matters

Practitioners and healthcare institutions place a premium on rapid, effective response to enforcement actions by the federal and state governments. Many of our clients work with us in a proactive, prophylactic manner, developing and designing compliance programs to avoid enforcement actions and compliance investigations before they can even begin. If a government agency has already initiated a compliance action, we work with government attorneys and regulators to obtain successful resolution of investigations. Our team has counseled clients in investigations, audits and reviews by numerous agencies, including Medicaid Fraud Control Units, state and federal attorneys general, and state and federal departments of health.

The regulatory enforcement challenges confronting healthcare entities and providers have resulted in our defense of practitioners, physician groups, licensed facilities, others in a variety of proceedings, including:

  • State and federal consumer fraud probes
  • Medicare, Medicaid, and private insurance company fraud and abuse investigations
  • False Claim Act, qui tam, and whistleblower litigation and defense
  • Fraud and abuse investigations and enforcement
  • Stark Law and anti-kickback matters

Self-Disclosure and its Benefits

Since 1998, healthcare entities have been able to self-disclose when they discover fraud and abuse regarding their participation in federal healthcare programs. However, in April 2013, the Department of Homeland Security Office of Inspector General (DHS-OIG) released significant changes regarding how self-disclosure works and the benefits of engaging in self-disclosure. The Self-Disclosure Program (SDP) is available to facilitate the resolution of matters that, in the disclosing party’s reasonable assessment, potentially violate federal criminal, civil or administrative laws. We recommend that any choice to disclose internal fraud and abuse in the SDP is an issue that should be discussed with counsel given the substantial benefits and potential concerns, which include:

  • A presumption against requiring integrity agreements in exchange for a release from permissive exclusion
  • A lower multiplier on damages than would normally be required
  • Mitigation of exposure for late repayment of Medicare or Medicaid funds
  • A streamlined settlement and resolution process