The Office of the National Coordinator for Health IT’s decision to pare down EHR certification attestation requirements will not impact the consistency of the program nor change expectations that developers will be held the same rigorous standards, according to an ONC official.
But some providers aren’t buying it.
“I don’t like it at all because it’s watering down what that certification means to me as a customer,” Michael Roberts, chief information officer at Highlands Health System and Highlands Regional Medical Center, told FierceHealthcare.
Highlands Health System, with locations across Kentucky, has two different EHR vendors: Cerner for Highlands Regional Medical Center, a 194-bed hospital, and eClinicalWorks for its 10 physician practices. Nearly four months after eClinicalWorks paid $155 million to settle claims it falsely obtained certification for its EHR software, Roberts still feels burned, and he’s concerned the new changes to the program will allow vendors to obtain certification with less oversight.
“When I hear that announcement, what I feel is you’re going to allow vendors who have already been caught cheating more flexibility and make it easier on them to cheat,” he said.
ONC insists that's not the case. The 30 criteria that can be self-declared are considered low-risk with very few nonconformity findings, according to an ONC official who spoke with FierceHealthcare to provide background about the program. Nearly half of the criteria are also “gap eligible,” meaning software that has passed 2014 standards can carry that certification forward in the 2015 edition.
“It may be these criteria fall into the category of rarely are they ever screwed up and its easy to tell if they weren’t done properly,” said Jeff Smith, vice president of public policy at the American Medical Informatics Association (AMIA). “It’s kind of like, you don’t need to certify that this car has four tires because, without that fourth tire, the car’s not going anywhere.”
Reducing the level of surveillance required by Authorized Certification Bodies (ACBs) diminishes what had become a heavy time commitment for providers, said the ONC official who requested anonymity. And allowing vendors to self-declare should redirect resources and time to redevelopment and responding to user needs.
Broadly, the official said the changes are an opportunity for the agency to meet demands from the White House to strip down federal regulations as much as possible. In January, President Donald Trump signed an executive order requiring federal agencies to eliminate two existing regulations for every new rule they introduce. A month later, Trump issued another order requiring agency heads to establish a regulatory reform task force and appoint a regulatory reform officer tasked with identifying unnecessary, outdated or ineffective regulations.
“I think its conceptually aligned with what HHS is trying to do in other areas, which is look at burdensome regulations that just aren’t having the kind of impact that the government thinks is important or necessary,” Smith said.
But the changes—at least in the immediate aftermath—haven’t been well-received among providers. Last week, David O. Barbe, M.D., president of the American Medical Association told FierceHealthcare self-declaration of EHR functions “could have unintended consequences that jeopardize patient health, care coordination, and physician success in the Quality Payment Program."
Others worried that even if the new certification process is less burdensome for vendors, that won’t trickle down to providers that are in the middle of migrating to 2015 Edition EHRs. Mari Savickis, vice president of federal affairs at the College of Healthcare Information Management Executives (CHIME) said members are worried the changes will “come at the cost of vendor accountability and product usability.”
"It will take some burden off the vendor, but they aren’t going to push that down to me," Roberts said. "The only possible benefit could be they have certified version quicker."