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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Despite the Trump Administration’s declaration of a state of emergency on October 26, 2017, the federal response to the opioid crisis largely languished on the back burner—much to the chagrin of states in the trenches of the opioid epidemic. However, based on the flurry of activity over the past several weeks, the federal government response now seems to be gathering substantive momentum, with various agencies and government actors launching attacks on all fronts—administrative, legislative, and enforcement alike. The federal government’s recent efforts present opportunities for health care organizations, life sciences companies, and health tech companies to get involved at the ground level to help influence opioid policy and provide needed products, services, and support to reduce the incidence of opioid abuse and address the health care needs of patients.

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The Department of Justice (DOJ) has further focused its sights on individual executives as responsible parties for corporate misconduct.  On September 9, 2015, Deputy Attorney General Sally Quillian Yates issued a strongly worded seven-page memorandum to all U.S. Attorneys and the Assistant Attorneys General of DOJ’s various divisions nationwide titled “Individual Accountability for Corporate Wrongdoing” (the “Memorandum”).  Overall, the Memorandum imposes further expectations that government attorneys will investigate the acts of individual executives and management personnel before providing cooperation credit to or allowing the resolution of a civil or criminal case against a corporate entity.  Moreover, the Memorandum serves as a tacit warning to defense counsel that it will be even harder to negotiate concessions for corporate liability without providing information about potentially responsible individuals that is satisfactory to the investigating agencies.
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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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