As 2018 gets underway, EHR vendors and users continue to face challenges and uncertainty.  There are three legal and regulatory issues in particular that we think are important to watch over the next 10 months:

1. Moving to the 2015 Edition Certification Criteria. Although CMS will not require hospitals or eligible professionals to use 2015 CEHRT in 2018, there are incentives for moving to the updated technology and, as ChartLux has observed, there are now many more 2015 CEHRT products available to users than there were at this time last year.  As a result, we should see more hospitals and practitioners deploy the 2015 CEHRT this year, which should give us a better picture of the successes and shortcomings of the 2015 Edition criteria.

2. Continued Implementation of MACRA. Eligible professionals will continue to transition to the Quality Payment Program (QPP), including the Merit-Based Incentive Payment System (MIPS), which incorporates the EHR requirements for eligible professionals.

3. Enforcement.  In the last year, there has been significant enforcement activity with respect to the EHR.  In May, DOJ announced a $155 million settlement to resolve a False Claims Act suit (originally brought by a relator) against eClinicalWorks for allegedly misrepresenting the capabilities of its software in the EHR certification process.  The settlement included a Corporate Integrity Agreement (CIA) that requires, among other things, the company to retain an independent third party to review eClinicalWorks’ software and quality control systems and make semi-annual updates to OIG.  In addition, in June, OIG issued a report in which it estimated that CMS made “$729 million in Medicare electronic health record incentive payments to eligible professionals who did not comply with Federal requirements.”

The extent to which DOJ and OIG will be pursuing enforcement actions is something to watch in 2018.  Further, the relator’s significant financial recovery in the eClinicalWorks case may incentivize future qui tam actions.