- Rep. Michael Burgess (R-TX), chairman of the House Energy and Commerce Committee’s health subcommittee, said he was “extremely disappointed” that information blocking regulations have not yet been implemented two years after passage of the 21st Century Cures Act.
“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 his opening statement during the panel’s Dec. 11 hearing on implementing the 21st Century Cures Act.
The act prohibits information blocking and directs ONC to develop rules about what does not constitute information blocking and is therefore permissible behavior, Burgess explained.
Rep. Gene Green (D-TX), ranking Democratic on the subcommittee, said that ONC’s information blocking rule is a “critical part of the law’s implementation and it will inform the Office of the Inspector General’s enforcement regarding information blocking. I look forward to this proposed rule’s release.”
In his written statement, National Coordinator for Health IT Donald Rucker explained that the process has taken so long because of the “significant stakeholder outreach” that has included more than 150 meetings with key health IT stakeholders.
“We look forward to receiving and addressing any comments that may be submitted, before issuing a final rule,” he noted. The Office of Management and Budget (OMB) is currently reviewing ONC’s information blocking proposed rule.
Burgess noted that Section 4003 of the act directs ONC to expedite interoperability and security among electronic health records (EHRs). He cited the draft of the Trusted Exchange Framework and Common Agreement released by ONC in January of this year as an example of progress in this area.
Rucker related that the framework and common agreement “seek to expand health information exchange nationwide and ensure that patients, providers across the care continuum, community and social services, and other stakeholders such as payers can access real-time health information.”
He said that ONC received more than 200 comments on the draft framework and agreement and plans to release an updated draft for public comment early next year.
To help implement the 21st Century Cures Act, ONC set a federal advisory committee called the Health IT Advisory Committee that has provided recommendations to the office. It has met 33 times and has provided recommendations in three priority areas: achieving interoperability, promoting and protecting privacy and security of health data, and expediting secure access by patients and caregivers to EHRs.
To promote standards and address the interoperability goals of the Cures Act, Rucker said his office published the 2018 Reference Edition Interoperability Standards Advisory and launched the US Core Data Interoperability (USCDI), which specifies a common set of healthcare record data classes required for health data interoperable exchange. The USCDI was another area where the Health IT Advisory Committee contributed recommendations.
Modification to the 2018 Reference Edition addressed additional health information categories, such as pregnancy status, care plans, patient identification, public health reporting, and provider-to-provider communication, and contained endorsements of 151 health information standards covering more than 60 interoperability needs, including clinical, public health, and research purposes.
Rucker related that his office has begun implementation of the EHR Reporting Program. In August 2018, ONC asked members of the public to share their views on the components of the EHR Reporting Program.
ONC received 77 public comment submissions from health IT developers and provider organizations representing the provider community, payers and health plans covering millions of beneficiaries, and consumer and quality improvement organizations representing patients and consumers.
“In summary, ONC has made great progress towards implementing key provisions of the 21st Century Cures Act,” Rucker said.
“These actions will maximize the potential of health IT and result in improved care and reduced cost. Due to development timelines and the size and complexity of the U.S. health system, it is important to note that nationwide interoperability will take time to achieve,” he concluded.