BREAKING: HHS/ONC Push Back Interoperability Compliance Deadlines
Facing the tough decision of balancing the industry’s need for greater interoperability against providers prioritizing COVID-19 response, federal health officials ultimately opted to extend the deadlines for stakeholders to comply with a variety of information blocking and other health IT-related mandates.
Released to the public on March 9, the Office of the Coordinator for Health IT’s (ONC’s) Cures Act Final Rule established exceptions to the 21st Century Cures Act’s information blocking provision and adopted new health IT certification requirements to enhance patients’ smartphone access to their health information at no cost through the use of application programming interfaces (APIs). In the Cures Act Final Rule, ONC set compliance dates and timeframes to meet certain requirements related to the information blocking and Conditions and Maintenance of Certification (CoC/MoC) requirements.
Then in April, ONC first responded to health IT stakeholders’ concerns about the COVID-19 pandemic by exercising its enforcement discretion and providing three months after each initial date or timeline for all new requirements under the ONC Health IT Certification Program. Importantly, even with the delay announced in April, the condition of certification for information blocking was still expected to go into effect on November 2 of this year.
Now, with a new interim rule issued on Oct. 29, federal officials say they’re providing the healthcare ecosystem additional flexibility and time to effectively respond to the public health threats posed by the spread of COVID-19. The interim final rule extends the Program compliance dates beyond those identified in the April 21 enforcement discretion announcement and establishes new future applicability dates for information blocking provisions. They key timeline extensions include:
- An extension from November 2, 2020 to April 5, 2021 for the rule’s information blocking provisions and information blocking CoC/MoC requirements
- A delay from May 2, 2022 to December 31, 2022 for 2015 Edition health IT certification criteria updates, except for the EHI export, which is extended until December 31, 2023.
- A delay to implement new standardized API functionality until December 31, 2022.
- A one-year calendar year extension for the submission of initial attestations, and submission of initial plans and results of real-world testing.
In a statement, Don Rucker, M.D., national coordinator for health IT, said, “We are hearing that while there is strong support for advancing patient access and clinician coordination through the provisions in the final rule, stakeholders also must manage the needs being experienced during the current pandemic.” Rucker added, “To be clear, ONC is not removing the requirements advancing patient access to their health information that are outlined in the Cures Act Final Rule. Rather, we are providing additional time to allow everyone in the healthcare ecosystem to focus on COVID-19 response.”
In an Oct. 29 media briefing discussing ONC’s decisions in more detail, Rucker doubled down on the point that the agency greatly values its interactions with all stakeholders, and had to balance “the extraordinarily important need” for the public to get their healthcare information—which has only been amplified by COVID-19—against being mindful of the fact that stakeholders are busy with a number of COVID-related activities. Ultimately, said Rucker, “We wanted to give folks additional time and flexibility to work on immediate COVID threats,” adding that the interim final rule “is a reflection of the health IT resources and related bandwidths in the provider community around the rule.”
Rucker noted that the overall goal here still remains the same in that the administration believes in pushing toward a patient-centric healthcare system, and wants patients and providers—especially in times of social distancing—to be able to effectively use electronic communications to their fullest underlying technical capabilities. “So this was a careful balancing of the absolute importance of interoperability and standardized APIs, with the reality that we have heard from providers that in a number of cases they are working so hard on some of these critical technical underpinnings to telehealth and related recourses. That has to be their first priority, but we want to make absolutely clear that it’s still our goal that all of this is done in the context of putting patients at fingertip-availability of medical information on their smartphones in a modern way.”
Rucker specifically added that a key factor in ONC’s decision had to do with the overall healthcare IT workload on providers engendered by COVID. “So it was really based on the priorities that providers have to set with their limited health IT resources. That was the gating activity, and that was why we extended it to April,” he said. Rucker noted it came down balancing “what has become essentially competing public interests—access to patients’ information to put them in charge [versus] the ability of the delivery system to implement these requirements.” He further pointed out that this is expected to be a one-time circumstance, and these extensions “are not gated by just purely the duration of COVID in the population, but by the health IT capacities of providers.”
In a statement today, Anders Gilberg, senior vice president, government affairs at the Medical Group Management Association (MGMA), said that the “six months of additional time afforded by the agency is critical for medical practices as they face significant operational and financial challenges associated with the national COVID-19 pandemic.” Meanwhile, Gilberg said that MGMA “maintains its concern that the information blocking regulation, with its many complex and confusing requirements and exceptions, will add unnecessary administrative burden on medical groups. We urge ONC to take full advantage of this additional time and develop comprehensive guidance and targeted educational resources.”
Similarly, the Premier healthcare alliance said in a statement that “the public health emergency has required an unprecedented response from healthcare providers that has left them with limited time and resources to implement new policies in response to complex information blocking requirements and associated exceptions. While Premier and our members are committed to expanding patients’ access to data, the delay will allow them to remain focused on combatting COVID-19 and bringing our nation back to health.” Premier also said despite the delays, it is urging "EHR vendors to move forward and expedite upgrades to their current technology, especially implementation of the USCDI; open, standardized APIs; and electronic health information export functionality.”
However, another industry group, the non-profit Pew Charitable Trusts, a research and policy organization, has previously stated publicly that the epidemic has emphasized the need to move the regulations forward without delay. The organization’s director of health IT policy and research, Ben Moscovitch, tweeted out today his dissatisfaction with ONC’s decision, calling it unnecessary.
Congress in 2016: EHRs must have APIs that help information get to patients and clinicians more easily
— Ben Moscovitch (@benmoscovitch) October 29, 2020
ONC in 2020: maybe by the end of 2022 🤷♂️ pic.twitter.com/rJOr9RlfcY
In a more updated statement, Moscovitch said, “Delaying requirements to adopt standard APIs until the end of 2022 is unnecessary and unwise. These technologies can dramatically speed up the exchange of health data between providers, public health agencies and patients, and faster data-sharing is vital to understanding and addressing public health crises. This delay leaves Americans without easier, at-home access to their medical records just when they need it most, and will slow the development of clinical decision support tools that can improve patient care.”
Stakeholders will have 60 days to comment on the interim final rule.
