As of October 3, 2019, the Office of Management and Budget completed its review of the proposed rules for “modernizing and clarifying” the Physician Self-Referral Regulations and revising the safe harbors under the Anti-Kickback Statute and rules regarding the Beneficiary Inducement Civil Monetary Penalties Law.

These regulations were the subject of two Requests for Information

Electronic health record (EHR) vendor Allscripts recently disclosed on an earnings call that it has reached a tentative agreement with the Department of Justice (DOJ) to pay $145 million to settle an investigation into the regulatory compliance of one of its recent acquisitions, Practice Fusion. This news, combined with DOJ’s other recent successful enforcement actions against EHR companies, represents a trend and should be a warning that compliance is a priority when it comes health IT. We anticipate that there will be more Anti-Kickback, HIPAA, and False Claims Act cases against similar health IT targets in the pipeline.

Allscripts acquired Practice Fusion, also an electronic health record company, in February 2018. According to the company’s public SEC filing from the first quarter of 2019, the investigation “relates to both the certification Practice Fusion obtained in connection with the U.S. Department of Health and Human Services’ Electronic Health Record Incentive Program and Practice Fusion’s compliance with the Anti-Kickback Statute and HIPAA.”


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The role of a health care entity’s governing board in the implementation and oversight of a compliance program is not always clear. Although board members are not often directly involved in care delivery, the Department of Health and Human Services’ Office of the Inspector General (OIG) views the governing board as integral to setting the tone for an organization’s compliance and oversight culture. To help the organizational leadership of health care entities understand how to oversee these compliance functions, the OIG, in collaboration with the Association of Healthcare Internal Auditors (AHIA), the American Health Lawyers Association (AHLA), and the Health Care Compliance Association (HCCA), has now published “Practical Guidance for Health Care Governing Boards on Compliance Oversight” (the “Guidance”).

The Guidance was developed through a landmark collaboration between government and private organizations representing key professionals in the health care compliance and integrity industry. First, the Guidance provides helpful distinctions between five essential functions that a robust compliance program should incorporate.

  • Compliance: to promote the “prevention, detection, and resolution” of identified issues that present risk under applicable laws, regulations, policies, or business standards.
  • Legal: to provide advice to the organization to address legal risks and help determine appropriate responses to potential and actual violations.
  • Internal Audit: to objectively assess “risk and internal control systems” (often data-based) used to evaluate the organization’s vulnerabilities and facilitate easy detection of compliance issues.
  • Human Resources: to manage “the recruiting, screening, and hiring of employees” who ultimately would have compliance-related responsibilities.
  • Quality Improvement: to review the clinical processes of the organization in view of patient needs, safety, and efficiency.

Then, the remainder of the 19-page Guidance includes references to other OIG publications, regulatory commentary, and external resources on board governance, compliance responsibilities, and fiduciary obligations. The overall substance of the Guidance provides educational information on the role of health care governing boards in compliance oversight, including the following takeaways:


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Every year, the Department of Justice (DOJ) and the Department of Health and Human Services Office of the Inspector General (OIG) report the results of their fraud prevention and recovery efforts to Congress.  As recounted in the recently released Health Care Fraud and Abuse Control Program (HCFAC) report, the overall amount recovered in FY 2014 was $1 billion less than what the agencies reported in 2013 ($4.3 billion).  Nevertheless, the report touted the $2 increase in the return on investment from DOJ and OIG’s fraud and abuse investigations overall (from $5.70 to $7.70).  The HCFAC report shows that, despite losing $62.1 million in funding beginning in FY 2013 due to sequestration, both DOJ’s and OIG’s antifraud work remains potent  and is growing more sophisticated.

Here is an overall comparison of the FY 2014 and FY 2013 reports:

DOJ Activities FY 2013 FY 2014
New Criminal Investigations 1,013 924
New Civil Investigations 1,083 782
Health Care Fraud Convictions 718 734
Total Allocation $573,667,581 $571,702,217
OIG Activities FY 2013 FY 2014
New Criminal Actions 849 924
New Civil Actions 458 529
Individuals Excluded from Federal Health Care Programs 3,214 4,017
Total Allocation $487,381,848 $485,824,633


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