Legislators on both sides of the aisle are cross with the Office of the National Coordinator for Health IT because of the stalled release of its hotly-anticipated rule on information blocking. In a House Energy and Commerce health subcommittee meeting Tuesday on implementing the 21st Century Cures Act, members of Congress peppered ONC head Don Rucker with questions about the status of the proposed rule.
In his opening statement, subcommittee chairman Michael Burgess, R-Texas, said he was "extremely disappointed" that regulations around interoperability and information blocking still don't exist two years after the passage of the Cures Act.
The rule, which will define what exactly constitutes information blocking and will implement other key provisions of Cures, has been languishing in the Office of Management and Budget since September. Although there was some speculation the rule would drop during ONC's annual conference late last month (or perhaps before the subcommittee meeting Tuesday), no one is quite sure when OMB will clear it for public release.
"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," Burgess said in a rare Republican rebuke of the administration.
Though multiple members of the subcommittee asked Rucker for some sort of update on the rule — its contents, its status, whether ONC required more legislative support to implement it — Rucker stayed largely mum.
"I am optimistic that [it will be released soon]," Rucker stressed. "But I am not in charge of these people." He was referencing OMB, which is a separate regulatory agency from ONC or HHS and provides budgetary oversight for government programs.
Rucker did hint at what sorts of research went into the draft rule. ONC looked at existing state law, security issues, mental illness use cases and charges to access data, especially those not linked to any software development costs.
Rep. Gene Green, D-Texas, who is set to retire at the end of his term Jan. 3, called the draft rule "critical" to implementing 21st Century Cures, noting it will "inform the Office of the Inspector General's enforcement regarding information blocking."
Rucker also ran through ONC's greatest hits for the health subcommittee panel, highlighting the joint ONC-CMS strategy for reducing administrative burden and implementation of the EHR Reporting Program, among other initiatives, in his update to Congress.
Under the Cures Act, HHS and ONC are required to regulate and improve the interoperability of healthcare information, taking action against any malfeasance or wrongdoers impeding the electronic flow of patient data. The bodies can impose up to $1 million in financial penalties per violation.
ONC brought expert outside perspectives into the crafting of the rule, Rucker said, including public listening sessions and more than 150 meetings with health IT stakeholders. "Why there is not interoperability is a very complex, multi-layered thing," he said, starting with the "raw complexity of human biology." But he expects the new rule will be "very effective" in increasing it.