United States: Health Care Enforcement Roundup: Increased FCA Enforcement Against EHR Companies

The federal government has offered substantial incentives to providers to adopt and use certified electronic health record (EHR) technology. As of October 2018, the federal government had paid over $38 billion in EHR incentive payments through the Promoting Interoperability Program (formerly, the Meaningful Use Program). Other federal health care program policies also encourage use of certified EHR technology through enhanced payments or avoidance of decreased reimbursement. These EHR-related payment policies, however, have triggered increased oversight and enforcement attention on EHR vendors who have allegedly misrepresented the capabilities of their EHR software and allegedly paid kickbacks to customers.

In 2017, DOJ announced a settlement with eClinicalWorks (eCW), an EHR vendor, to resolve an FCA lawsuit originally brought as a qui tam action by a whistleblower. DOJ's complaint-in-intervention alleged that eCW made material false statements and concealed material facts about the capabilities of its software in connection with the government's EHR certification process.1 It also alleged that eCW paid purported kickbacks in connection with certain marketing arrangements (i.e., a referral program, site visit program, and a reference program) with influential customers to induce them to recommend eCW's EHR software, in violation of the federal Anti-Kickback Statute (AKS).[2]

As part of the settlement, eCW agreed to pay $155 million and to enter into a novel, five-year Corporate Integrity Agreement (CIA) with the HHS OIG. Among other things, the CIA required eCW to engage an independent Software Quality Oversight Organization to assess eCW's software quality control systems and to regularly report to OIG and eCW on its reviews and recommendations. Further, the CIA required eCW to offer free upgrades and data transfers to its current customers. This was a ground-breaking settlement that raised the question of whether this was the beginning of government and whistleblower attention on (and FCA actions against) EHR vendors. This question was seemingly answered in the affirmative when DOJ announced a second settlement with an EHR vendor in early 2019.

On February 6, 2019, EHR vendor Greenway Health LLC (Greenway) entered into a similar settlement to resolve an FCA case filed by the US Attorney's Office in Vermont. Interestingly, a whistleblower did not initiate the Greenway case. Rather, DOJ pursued it directly. Like eCW, Greenway faced allegations that its EHR system did not function in the way it represented it during the certification process.Sup>3 One specific allegation was that Greenway provided some customers whose EHR software was improperly calculating certain meaningful use measures (which providers are required to achieve to be eligible for incentive payments) with incorrect calculations in order to enable them to receive incentive payments.4 According to DOJ, this allegedly caused some Greenway customers to submit false claims to HHS for payment under the Promoting Interoperability Program.

Like in the eCW case, the government complaint against Greenway also alleged that certain payments from Greenway to its customers pursuant to certain reference, referral, and site visit programs violated the AKS.5 Additionally, the government accused Greenway of giving its favored customers extravagant gifts, including "iPads, meals, travel, tickets to sporting events and entertainment, all for the purpose of inducing these users to either continue using Greenway's products or recommend Greenway to other health care providers . . . ."6 To resolve these allegations, Greenway agreed to pay $57.25 million, and to enter into an eCW-like CIA.

Practice Note: While many questions remain, including whether a court would agree with DOJ that the AKS applies to these situations, we expect to see continued government and relator scrutiny of EHR vendors. In light of this continued focus, EHR vendors should ensure that they: (1) take care to accurately and transparently demonstrate their software during HIT certification program testing; (2) review, and consider improvements to, their systems and other procedures for identifying, responding to and correcting software design and quality issues that call into question EHR software's conformity to applicable EHR certification criteria or present patient safety or clinician usability risks; and (3) review existing customer reference, referral and marketing arrangements for compliance with the Anti-Kickback Statute. If an EHR vendor receives investigative requests from the federal government, it should engage outside counsel.

This blog post was originally published in McDermott's Health Care Enforcement Quarterly Roundup | Q1 2019.  Click here to view the full report. 

Footnotes

United States , ex rel. Brendan Delaney v. eClinicalWorks, LLC, Complaint in Intervetion, 2:15-CV-00095, D. Vermont (May 12, 2017).

Id. ¶¶79-85.

Id.

United States v. Greenway Health, LLC, Complaint, 2:19-CV-00020 at ¶¶ 76-112, D. Vermont (February 6, 2019).

Id. ¶¶113-125.

Id.  ¶¶ 126-27.

Health Care Enforcement Roundup: Increased FCA Enforcement Against EHR Companies

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