- The Office of the National Coordinator for Health IT (ONC) announced two changes to the ONC Health IT Certification Program in efforts to reduce burden on health IT users and developers.
- The agency will approve more than 50% of test procedures to be self-declaration.
- In addition, the agency is exercising discretion for randomied surveillance of certified health IT products. "ONC will not, until further notice, audit ONC-Authorized Certification Bodies (ONC-ACBs) for compliance with randomized surveillance requirements or otherwise take administrative or other action to enforce such requirements against ONC-ACBs," Elise Sweeney Anthony, director at the office of policy, and Steve Posnack, director of the office of standards and technology, wrote on a Health IT Buzz Blog post.
The changes are in line with the HHS department under Secretary Tom Price, who supports reduced regulatory burden for physicians and end-users of technology.
With the self-declaration change, ONC revised the agency-approved procedures for 30 out of 55 certification criteria adopted to help support the Quality Payment Program (QPP). Now deemed to be "self-declaration only," health IT developers can self-declare their products to conform to these 30 criteria points without vetting the product through a ONC-Authorized Testing Laboratory (ONC-ATL).
"By making this change, ONC enables ONC-ATLs and health IT developers to devote more of their resources and focus on the remaining interoperability-oriented criteria, aligning with the tenets of the 21st Century Cures Act," Anthony and Posnack wrote. "In addition, health IT developers are still required to meet certification criteria requirements and maintain their products’ conformance to the full scope of the criteria. Any non-conformity complaints received and associated with these certification criteria would continue to be reviewed and investigated by ONC-ACBs."
For the randomized surveillance change, Anthony and Posnack wrote they expect the enforcement discretion to allow ONC-ACBs to prioritize complaint driven, or reactive, surveillance and devote their resources to certifying health IT to the 2015 Edition. "These new actions we are announcing today will support greater availability of certified health IT for providers participating in the CMS’ Quality Payment Program," they wrote.
The changes come at a time when EHR vendors are still struggling to released 2015 Edition Certified EHR Technology products that Meaningful Use (MU) Stage 3 requires. These changes should cut down on the regulatory burden before certification, and allow products to reach the market quicker. This will help providers as they prepare to participate in QPP's Advancing Care Information (ACI) section and participate in Stage 3 of the MU program.
In the MACRA proposed rule for 2018, CMS eased EHR technology requirements for the ACI portion, allowing Merit-based Incentive Payment System eligible clinicians to continue to use 2014 Edition EHR certified technology for 2018's ACI calculations. CMS finalized a similar provision in the Medicare Inpatient Prospective Payment System for FY2018 in August.
The MACRA rule is expected to be finalized in November.
A recent MGMA survey found practices rated QPP as most burdensome over compliance with federal regulations, followed by lack of electronic attachments for claims and prior authorization; audits and appeals; lack of EHR interoperability; and payer use of virtual credit cards.
While HHS eased up on the requirements for use of certified products because few products are on the market, ONC's recent changes show a push to allow developers to quickly get their tools to market in order to facilitate consumer choice.