On May 31, 2017, the U. S. Department of Justice (DOJ) announced that eClinicalWorks (ECW) agreed to pay a $155 million settlement and enter a corporate integrity agreement with the OIG to resolve allegations that ECW caused its health care provider customers to submit false Medicare and Medicaid claims for meaningful use payments in violation of the False Claims Act (FCA). Under the corporate integrity agreement, ECW agreed to strict compliance and reporting obligations and to provide the latest version of ECW’s EHR software to each of ECW’s current customers free of charge.
The government had alleged in part that ECW concealed from its independent certifying entity that its EHR software failed to comply with certification requirements. For example, the government contends that ECW modified its software to “hardcode” only the 16 drug codes required for testing, rather than the software’s complete drug code database. Additional allegations include: ECW’s software did not accurately record user actions in audit logs; did not meet data portability requirements; failed to perform required drug interaction verification; and did not always accurately record diagnostic imaging orders.
This settlement has raised significant concerns throughout the health information technology industry and it may indicate increasing FCA action against vendors of EHR technology (CEHRT) certified through the HIT certification program of the Office of the National Coordinator of HIT (ONC).
Physicians should consult with their HIT vendors to see if they are reviewing and considering improvements, to their systems, and to other procedures for identifying and correcting software design and quality issues that may not conform to the applicable EHR certification criteria, or which present patient safety or clinician usability risks. The settlement is also cause for HIT vendors to review existing customer referral and marketing arrangements compliance with the Anti-Kickback Statute.
The DOJ alleged that ECW caused its customers to receive unearned EHR incentive payments by submitting false attestations of meaningful use of CEHRT. Based on the complaint, it appears the DOJ did not pursue ECW’s physician practice customers for the unearned incentive payments, in part, because ECW’s customers “unknowingly” submitted false attestations, reasonably believing that ECW’s EHR software was properly certified. The FCA requires the government to establish that false claims were submitted knowingly.
The DOJ also alleged that ECW paid kickbacks to influential customers to induce them to recommend ECW’s EHR software in violation of the Anti-Kickback Statute. DOJ specifically alleged that ECW paid the purported kickbacks through a referral program, site visit program, and a reference program.
According to the complaint, under the referral program, ECW paid current customers up to $500 for each provider they referred who executed a contract with ECW, with customer payments totaling almost $144,000. Under the site visit program, ECW paid customers to host prospective customers; payments varied based on the number hosted and whether the hosted customer, or prospect, licensed ECW’s software. Under the reference program, ECW paid current customers as much as $250 to serve as references for the ECW software and speak to prospects.
The OIG has taken a longstanding position that marketing payments could technically implicate the Anti-Kickback Statute, but the OIG has also recognized that payment for marketing services are commonplace and unavoidable without banning marketing activities entirely. OIG advisory opinions and other guidance set forth a multi-factored facts-and-circumstances analysis for distinguishing between proper and improper marketing activities outside the Anti-Kickback Statute Safe Harbors.
Ongoing CIA Requirements
The five-year corporate integrity agreement (CIA) that ECW entered includes several requirements not usually included in CIAs. Some of the requirements are:
- Free Upgrades – ECW must provide the latest version of the its EHR software to current customers at no charge. This includes software updates that correct noncompliance with EHR certification criteria and the latest updates to any drug database supported by the EHR software and used by the customer.
- Free Data Transfer – ECW must transfer an existing customer’s data without penalties or service charges to the customer or the customer’s designated successor vendor.
- Quality Assurance Program with Software Standards and Practices – ECW must establish a program with “professionally recognized software development, quality assurance, and risk management standards and practices appropriate to the nature and purposes of EHR systems (including supporting clinical decision-making and the provision of medical care to patients).” ECW also must proactively monitor information about potential software defects, usability problems and other issues that may impact patient safety or EHR certification.
This settlement by eClinicalWorks with the U.S. government for allegedly misleading users about its capabilities, in part by cheating on certification tests, raises questions about how EHRs should be certified and monitored. Physicians may need to assess how the settlement and other current government investigations will affect their ability to retain previously received “meaningful use” payments.
Written by: Clay J. Countryman