Go to main navigation
103 Carnegie Center, Suite 323, Princeton, NJ 08540
Call for Consultation 609.297.5942 609.297.5942


Resolving Compliance and Self-Disclosure Issues for Health Care Providers

Navigating the regulatory and statutory landscape for practice groups and practitioners

Combating health care 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 health care providers. At Buttaci Leardi & Werner, LLC, we meld our extensive experience in health care 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 health care 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 health care entities and providers have resulted in our defense of practitioners, physician groups, hospitals, academic medical centers, health systems and others in a variety of proceedings, including:

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

FDA investigations and DEA audits

The Food and Drug Administration (FDA) has increasingly become more active in investigation and enforcement actions, including going after providers for unintentional violations. The Drug Enforcement Agency (DEA) has begun using data mining and other technology to analyze, investigate and enforce regulatory and statutory compliance with regard to controlled substances. Both agencies and their state counterparts are able to seek civil penalties, criminal sanctions and other punishments against providers and entities that violate the law. At Buttaci Leardi & Werner, we work with clients to address risk management in situations such as:

  • “Off label” use of drugs and medical devices
  • Compliance with the federal Food, Drug and Cosmetic Act
  • Internet prescribing of pharmaceuticals
  • Discrepancies in medication ordering procedures

Self-disclosure and its benefits

Since 1998, health care entities have been able to self-disclose when they discover fraud and abuse regarding their participation in federal health care 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. At Buttaci Leardi & Werner, 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

Contact us for more information

To learn about how Buttaci Leardi & Werner, LLC can assist with self-disclosure and compliance investigations, please contact us online or call us at 609.297.5942.