DOJ announced on February 6, 2019, the Settlement Agreement resolving allegations in DOJ’s Complaint that Greenway caused its customers to submit false Medicare and Medicaid claims for payments under the EHR Incentive Programs in violation of the FCA and that it paid illegal kickbacks to current customers to recommend Greenway products (that are used to generate incentive payments or avoid penalties under the EHR Incentive Programs) to new customers. Under the Settlement Agreement, Greenway agreed to pay approximately $57 million to resolve the allegations without admitting liability. Greenway also entered into a five-year CIA with strict compliance oversight, reporting obligations and costly obligations to provide the latest version of Greenway’s EHR software to each of Greenway’s current customers at no additional charge.
This settlement comes nearly two years after eCW entered into a groundbreaking settlement with DOJ. At that time, we wondered whether it may be a sign of increasing FCA actions against vendors of EHR technology (CEHRT) certified through the health information technology (HIT) certification program of the Office of the National Coordinator of HIT (ONC). Statements by the United States Attorney for the District of Vermont, Christina E. Nolan, in the DOJ press release discussing the Greenway settlement seem to answer that question very directly in the affirmative. She says that “EHR companies should consider themselves on notice.” It is notable that, unlike the eCW case, the Greenway case was not initiated by a relator, but pursued by DOJ directly. In light of the government’s continued focus on vendors of EHR technology used to earn payments or avoid penalties for failing to succeed under the EHR Incentive Programs (or their successor value-based payment programs), HIT vendors should:
- Take care to accurately and transparently demonstrate their software during HIT certification program testing
- 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
- Review existing customer reference, referral and marketing arrangements for compliance with the Anti-Kickback Statute.
The following sections of this On the Subject discuss the key elements and implications of the Complaint and CIA.
Just like in the eCW case, DOJ’s Complaint alleged that Greenway made false statements about Greenway’s EHR software and made improper payments (i.e., kickbacks) to referral sources in violation of the Anti-Kickback Statute. In addition, the Greenway case also involved allegations related to improper calculation of certain EHR incentive program measures.
First, DOJ alleged that, in an effort to be one of the first companies with its product certified to the 2014 Edition of ONC’s EHR certification criteria, Greenway attempted to “shortcut” certain functionality, allowing its software to pass certification testing, without actually having all of the functionality required under the certification program regulations. According to DOJ, Greenway hard coded its software to pass publicly available test scripts relating to the use of RxNorm and SNOMED CT standards, even though at the time of testing and certification, as well as later when deployed “in the field,” Greenway’s software did not fully utilize those standards as required. DOJ asserted that, notwithstanding this, Greenway falsely represented to the entity performing the testing and certification that Greenway’s software met the required certification criteria and could do so when deployed in production (i.e., outside of the testing environment during live use with patients) in order to obtain certification. Because of this alleged false representation, DOJ asserts, Greenway’s software did not qualify as CEHRT. However, in order to be eligible for incentive payments under the EHR incentive program (or, more recently, avoid downward adjustments in Medicare reimbursement under the Medicare Physician Fee Schedule or Medicare Inpatient Prospective Payment System), health care providers are required to use CEHRT in accordance with “meaningful use” objectives and measures under the Incentive Programs.
As a result, DOJ alleged that Greenway caused its customers to receive unearned EHR incentive payments by submitting false attestations of meaningful use of CEHRT. Based on the Complaint, and just like in the eCW case, it appears that DOJ did not pursue Greenway’s customers for the unearned incentive payments, in part, because Greenway’s customers “unknowingly” submitted false attestations (reasonably believing that the Greenway EHR software was properly certified as reported on the ONC’s website) and the FCA requires the government to establish that false claims were submitted knowingly. CMS issued a statement that it would not view any meaningful use payment to eCW users as overpayments where those providers relied in good faith on eCW’s representation that its product qualified as CEHRT. Presumably, CMS would take the same position for Greenway customers.
Inflated Incentive Program Measures
In addition to using CEHRT, health care providers were required achieve certain meaningful use measures to be eligible for incentive payments under the EHR Incentive Programs. DOJ alleged that an earlier version of Greenway’s EHR software miscalculated a particular measure related to clinical care summaries, that Greenway became aware of the issue in the middle of a performance year and that Greenway chose not to correct it to avoid having customers that previously thought they were on target to receive incentive payments (based on the miscalculation) actually fail to meet the measure and miss out on incentive payments. Additionally, even after Greenway rolled out a patch to fix the problem for the subsequent Incentive Program year, DOJ asserted that some customers did not receive the patch until later in that year and found themselves in the same position as before—they appeared to be on target to meet the measure when they were, in fact, not. So Greenway, DOJ alleges, provided the affected customers with incorrect calculations in order to receive incentive payments.
Like in the eCW case, DOJ alleged that certain payments from Greenway to its customers pursuant to certain reference and referral programs violated the Anti-Kickback Statute. Despite nearly tripling the number of pages dedicated to the kickback discussion in the Greenway complaint (from one page in the eCW complaint-in-intervention to nearly three in the Greenway case), the details about DOJ’s objections to site visit and reference programs—which could be viewed as typical and commercially reasonable marketing arrangements for information technology that involve customers providing actual marketing services in exchange for the payment—remain scant. Further, federal courts may interpret the Anti-Kickback Statute differently than DOJ and conclude, contrary to the DOJ’s assertions in the Complaint, that commercially reasonable marketing arrangements are not kickbacks.
For example, it is a common commercial practice to select references who will be complimentary of the organization or product that is the subject of the reference rather than selecting references who will be unenthusiastic, neutral or negative. Yet, DOJ seems to view this practice as suspect. We note that it does not appear DOJ has pursued these types of marketing arrangements absent an allegation of misrepresentations about the software’s certification. In other words, that DOJ may view engaging customers (to whom DOJ believes the company made misrepresentations) to market that product to others as a problematic activity undertaken to further promote the misrepresented product.
The OIG has for years consistently stated that marketing payments technically implicate the Anti-Kickback Statute, but it has also recognized that payment for marketing services are commonplace, and in fact, unavoidable without banning marketing activities entirely. Various 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. The analysis examines the nature of the payment, the type of marketing activity (i.e., active or passive), the type of item or service marketed, the intended audience, and the identity of the marketer and his or her relationship with the intended audience. However, the presence or absence of any of these factors does not necessarily mean that an arrangement violates the Anti-Kickback Statute. Yet DOJ’s discussion of the kickback allegations in the Greenway Complaint, as in the eCW complaint-in-intervention, does not seem to apply this long-standing analytical framework for marketing arrangements.
Ongoing CIA Requirements
In addition to the large monetary settlement payment, Greenway agreed to comply with requirements in a CIA that were similar to those imposed on eCW. What were novel requirements in 2017 appear to have become the standard when OIG imposes CIA obligations on EHR vendors in connection with these types of cases. For example, the CIA requires Greenway to retain an independent review organization or organizations to assess its software quality controls and compliance systems and to review arrangements for compliance with the Anti-Kickback Statute. Further, Greenway is required to offer its customers the option of receiving a free upgrade or transfer to alternative Greenway product or to transfer data to another vendor’s EHR product without cost.
Implications for HIT Vendors
The Greenway settlement demonstrates continued scrutiny of EHR vendors by the government for compliance with the EHR certification criteria because CEHRT may enable health care providers to earn incentive payments or other enhanced reimbursement or avoid decreased reimbursement under more recent federal health care program rules. The CIA makes clear that the government is not only concerned about improper reimbursement to health care providers, but also patient safety issues caused by defective software and poor usability as well as kickbacks to referral sources. Consequently, EHR and other HIT vendors should consider the following steps:
- Develop and implement a compliance program that reflects the elements of an effective corporate compliance program set forth in DOJ and OIG compliance program guidance for the health care industry;
- Develop and implement policies, procedures and practices for addressing EHR certification criteria, patient safety and EHR usability considerations into the ongoing software development and design process;
- Develop and implement procedures for employees, customers and other persons to report patient safety, usability and compliance issues to vendor management and procedures for promptly tracking, monitoring and resolving the issues;
- Identify, review and resolve any currently known or suspected EHR certification criteria compliance issues and patient safety issues;
- Evaluate current showcase or reference site arrangements, referral arrangements and other marketing arrangements outside the Anti-Kickback Statute safe harbors with persons in a position to generate new customers and new business to determine whether they reasonably comply with OIG guidance regarding marketing;
- Develop and implement policies, procedures and practices for complying with the Anti-Kickback Statute, including policies for evaluating whether marketing arrangements with referral sources comply with the Anti-Kickback Statute; and
- Implement a comprehensive training program to address the range of health care regulatory compliance matters addressed by the CIA and foster a culture of health care regulatory compliance.