AAFP Pushes for More Changes to ONC Rule Compliance Dates
Ongoing Pandemic Dictates Further Delay in Applying Information Blocking Regulations
January 21, 2021, 1:47 pm News Staff — The AAFP last month urged the Office of the National Coordinator for Health IT to further delay the deadline for physicians, other clinicians and health care organizations to comply with information blocking provisions outlined in the 21st Century Cures Act.
That call came in a Dec. 17 letter signed by AAFP Board Chair Gary LeRoy, M.D., of Dayton, Ohio, that was sent to ONC National Coordinator Don Rucker, M.D. The letter was sent in response to a request for comments on the agency’s interim final rule “Information Blocking and the ONC Health IT Certification Program: Extension of Compliance Dates and Timeframes in Response to the COVID-19 Public Health Emergency.”
In the rule, ONC acknowledged the urgent conditions created by the COVID-19 pandemic and emphasized its “understanding that caring for patients with COVID-19 is of utmost importance” to the nation’s physicians. Accordingly, the agency announced, the information blocking compliance deadline for physicians, other clinicians and health care organizations would be extended from Nov. 2, 2020, to April 5, 2021.
The Academy welcomed the agency’s move, saying it “strongly supports delaying the applicability date of information blocking regulations” for physicians. But more is needed, the letter stated.
“Given the latest surge in COVID-19 cases across the nation, we recommend that ONC further extend this delay through the end of the national public health emergency or until July 31, 2021, whichever comes later.”
The AAFP has previously praised the agency for its efforts to improve interoperability and accessibility of patient health records and has expressed its support for regulations that prohibit physicians and health IT developers from unnecessarily blocking the sharing of patients’ health information, although it has voiced concerns about the complexity of certain elements of the process for physicians.
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“The AAFP is concerned that the information blocking exceptions previously finalized by ONC are overly complex and will result in additional administration burdens for family physicians,” the letter noted. “It is unclear to family physicians how and when to appropriately utilize the information blocking exceptions and what their obligations are when information isn’t easily sharable.”
Delaying the compliance date would provide ONC an opportunity to further “streamline the requirements for physicians and provide more clarity through additional guidance on how to meet information blocking exceptions,” said the Academy.
Furthermore, the letter noted, ONC has yet to provide documentation guidance in the event a physician is subjected to an information blocking investigation.
“In order to minimize the burden on physicians and their practices, ONC and the Office of the Inspector General should clearly outline documentation and other requirements before the information blocking applicability date,” the AAFP stated. Doing so would allow practices to modify their administrative and clinical workflows to enable them to obtain the necessary documentation at the same time they make changes needed to comply with the regulations.
The Academy took issue with other changes included in the interim final rule. ONC had previously finalized regulations and certification requirement timelines EHRs must meet to be considered Certified EHR Technology, which CMS requires physicians and other entities to use to participate in various programs. Now, however, the agency seeks to extend several of those timelines to Dec. 31, 2022, or even Dec. 31, 2023.
One such extension, in particular, stands to have a negative effect on physicians’ ability to transmit relevant patient data efficiently, the AAFP contended. In the rule, ONC said it will delay the compliance timeframe for the electronic health information export requirement for CEHRT from Dec. 31, 2022, to Dec. 31, 2023.
As background, the ONC rule defines EHI as the electronic protected health information (in keeping with HIPAA regulations) contained in a designated record set, regardless of whether the records are used or maintained by or for a covered entity.
In the typical physician’s office, that designated record set includes patients’ medical and billing records, as well as records physicians use, in whole or in part, to make decisions about individual patients.
The EHI export requirement, when implemented, will enable physicians to send all of a patient’s relevant health information in a single electronic file, greatly streamlining information-sharing among members of the patient’s care team.
“Given the significant benefits of enabling physicians to share patients’ EHI, compliance with the EHI export requirement should not be delayed beyond December 2022,” the AAFP stated.
On the other hand, said the Academy in its letter, the time period for which the definition of EHI is limited to data elements in the U.S. Core Data for Interoperability, a standardized set of health data classes and constituent data elements, should be extended beyond the current Oct. 6, 2022, timeframe. To minimize the added toll on already overtaxed family physicians, ONC should delay implementation of the broader definition of EHI until the EHI export certification requirements go into effect at the end of 2022.
“The AAFP is concerned it will be very burdensome for physicians to respond to all EHI sharing requests in a timely manner if the EHI export functionality is not required and implemented. Instead, we recommend that ONC implement the broader definition of EHI after EHI export functionality is required of CEHRT developers and there is more guidance for HHS on how information blocking claims will be evaluated and enforced,” the letter urged.
The sentiments expressed in the December letter are a logical extension of points the Academy has been making since HHS first announced data-sharing rules implementing the Cures Act’s interoperability and patient access provisions last spring.
At that time, AAFP Board Chair Gary LeRoy, M.D., of Dayton, Ohio, welcomed the agency’s action.
“Family physicians routinely struggle with acquiring the right health information to make the best decisions with their patients,” he said in a March 11, 2020, statement. “The lack of interoperability is a fundamental issue leading to increased cost, burden and frustration, as well as lowering quality and health.”
Noting that the rules offer “a good starting point to guide regulators and vendors,” LeRoy called on HHS to implement them in a manner consistent with policies outlined in the agency’s overall strategy for a nationwide interoperable health care system.
“Part of the challenge in implementing the 21st Century Cures Act is to thread the needle between penalizing true information blockers while not adding complexity, uncertainty and burden upon practices who are not blocking information.”