A long-awaited rule that will define exceptions to information blocking—and the hefty fines that go with it—has finally landed at the Office of Management and Budget.
The proposed rule, mandated by the 21st Century Cures Act, was submitted to OMB on Monday. While the regulatory review is short on details, it mimics language from the Department of Health and Human Services’ Spring 2018 Unified Agenda which included updates to EHR certification requirements, voluntary adoption of the Trusted Exchange Framework and Common Agreement, certification of health IT for pediatric providers and information blocking.
Stakeholders from across the healthcare industry will be closely watching that last portion. Under the 21st Century Cures Act, the Office of Inspector General (OIG) can fine healthcare entities $1 million for each instance of information blocking. But first, the Office of the National Coordinator for Health IT must define exceptions to information blocking that regulators can use.
Given that the rule is marked “economically significant,” it will likely remain at OMB for several weeks, says Jeff Smith, vice president of public policy at the American Medical Informatics Association (AMIA).
“I would be surprised if it’s public before October,” he told FierceHealthcare.
🚨 @ONC_HealthIT rule implementing 21st Century Cures provisions received by OMB yesterday. Some key provisions expected:— Ben Moscovitch (@benmoscovitch) September 18, 2018
1) API requirements so that “all data elements” made available
2) information blocking
3) voluntary criteria for EHRs used in pediatric care #healthIT pic.twitter.com/P2Hrnbma1D
Several groups, including AMIA, Health IT Now and the American Academy of Family Physicians, have criticized ONC for failing to make headway on the information-blocking rule. In a letter to National Coordinator Donald Rucker, M.D., last month, the groups said the agency’s delay “needlessly creates uncertainty for vendors and providers alike.”
“Health IT Now is pleased that ONC’s information blocking rule is now under review at OMB," Health IT Now Executive Director Joel White said in a statement to FierceHealthcare."We eagerly await the opportunity to review the full text of the proposed rule as soon as it is available and are hopeful that it will provide clear rules of the road in the fight against harmful information blocking practices."
The Electronic Health Records Association (EHRA), which includes some of the country’s most prominent EHR vendors, has urged the agency to ensure that the rule is reserved for information blocking that contradicts what is “reasonable and necessary.”
“We look forward to the opportunity to review the proposed clarifications to the information blocking definitions and work with OIG and ONC to minimize ambiguity of these definitions,” an EHRA spokesperson said in an emailed statement. “Unambiguous definitions are essential to effective and minimally disruptive implementation.”
While the information-blocking portion of the rule is likely to generate heated debate, the proposal is also expected to address the use of APIs. It also includes Cures requirements around conditions of maintenance and certification for health IT developers, which Smith called “a Russian Doll of nested policies."
“For example, the EHR Reporting Program—for which there is an RFI open for comment—is part of the Conditions,” he said. “There are several additional requirements for the conditions and maintenance of certification in section 4002, so it’ll be interesting to see how ONC parses the statute.”