A long-awaited Office of the National Coordinator for Health IT rule to stem information blocking has passed the 90-day window the Office of Management and Budget had to review it, renewing criticism from the industry asking what the hold-up is.
The proposed rule to define information blocking under the 21st Century Cures Act was sent from ONC to OMB Sept. 17, setting a timer ticking that buzzed over the weekend to no avail.
ONC previously said that the rule would be released in April, then September, October, November and now half of December have come and gone without a hint of the new rule, and ONC and OMB have remained tight-lipped about any updates to the timeline more than two years after Cures was enacted.
The Cures Act makes it illegal for EHR vendors, health systems and other purveyors of health data to interfere with the free exchange of patient information.
For HHS and the Office of the Inspector General to be able to enforce that tenet of the legislation, ONC needs to define what is allowed and what is not.
Proposed rules that are economically significant often take longer for OMB to review, but it's rare that the agency misses a deadline — although not technically illegal.
Two interoperability rules currently stalled under budget review — ONC's information blocking and CMS' industry interoperability standard proposals — don't have strict legislative timeframes the budget office has to meet.
Both rules have likely gone through several rounds of so-called pass-backs, where the rules are shuttled between their respective agencies and OMB for clarifications, edits and changes. Depending on how extensive OMB edits are, it may take more and more time to get the next pass-back.
Still, the delay is "stunning," said Health IT Now Executive Director Joel White. "Patients and providers have looked on with disappointment as the administration blows through one missed deadline after another for publicly releasing a proposed information blocking rule," he said.
Legislators are not happy. In a House Energy and Commerce health subcommittee meeting last week, members of Congress peppered ONC National Coordinator Don Rucker with questions on the status of the proposed rule.
Subcommittee chairman Michael Burgess, R-Texas, said he was "extremely disappointed" at the lack of regulations around interoperability, stressing that "it is hard to explain to people that Congress provided the tools necessary for doctors and patients to better coordinate their care through the sharing of patient data, but nothing has changed."
The new rule will help, according to Rucker, who also said the country has about a C- grade on interoperability currently.
But the public can't know the contents of the rule until it's formatted and published in the Federal Register — after it's cleared by OMB and returned to ONC, as stipulated in the Administrative Procedure Act.