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Earlier this month, OIG issued a Special Fraud Alert on Speaker Programs warning drug and device companies and health care providers that it has significant concerns about payments for “speaker programs.” Based on recent investigations and enforcement activity, the OIG has found that a number of speaker programs sponsored by drug and device manufacturers violate the federal Anti-Kickback Statute (AKS). OIG is skeptical about the educational value of speaker programs provided under circumstances that are not conducive to learning and to audience members who have no legitimate reason to attend. Additionally, OIG questions the value of such events given that health care providers can access the same or similar information online, on the product’s package insert, third-party educational conferences, medical journals, and more. Because all of this material is already available, OIG warns “that at least one purpose of remuneration associated with speaker programs is often to induce or reward referrals” in violation of the federal Anti-Kickback Statute (AKS).

OIG defined speaker programs as drug or device “company-sponsored events at which a [outside] physician or other health care professional (collectively, “HCP”) makes a speech or presentation to other [outside] HCPs about a drug or device product or a disease state on behalf of the company” using a presentation developed and approved by the company. HCPs are paid an honorarium and attendees are paid generally through free meals and drinks, for example.

Based on its investigations to date, OIG provided an illustrative list of speaker program characteristics that result in higher level of scrutiny with respect to AKS violations:Continue Reading OIG Sends a Special Fraud Alert on Speaker Programs

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.”Continue Reading Allscripts Close to Reaching Deal with DOJ for Health IT Certification, Anti-Kickback Statute, and HIPAA Issues

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:Continue Reading OIG Teams Up With Private Sector to Provide Guidance to Health Care Governing Boards

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

Continue Reading FY 2014 HCFAC Report Shows Increasing DOJ and OIG Fraud-Fighting Efficiency