Trump administration may push back interoperability rules, again: Rucker

The Trump administration may push back deadlines for healthcare companies to comply with information blocking and interoperability regulations for a second time as providers face ongoing stress from COVID-19.

“We’ve had some adjustments to the timing of our rule and the companion CMS rule, and we’re monitoring closely the situation in terms of further adjustments,” Don Rucker, head of the Office of the National Coordinator for Health IT, said Thursday at CB Insight’s Future of Health conference. “All I can say at this point is we’re actively aware of the COVID pandemic and looking at any needed changes.”

HHS has sent the Office of Management and Budget an interim final rule, called Information Blocking and the ONC Health IT Certification Program: Extension of Compliance Dates and Timeframes in Response to the COVID-19 Public Health Emergency, received on Sept. 17.

ONC declined to comment on the rule. But the title implies it will extend dates identified in the sweeping information blocking provisions — notably, the looming November compliance deadline for providers — and dates for the Conditions and Maintenance of Certification provisions requiring EHR platforms to be interoperable.

The two rules meant to stop information blocking in healthcare were finalized by the Trump administration in March, before the full brunt of the coronavirus pandemic walloped the U.S. As a result of COVID-19’s intensifying strain on the healthcare system, about a month later HHS pushed back deadlines to come into compliance with the regulations.

But the earliest deadline, November, is just a little over a month away, causing providers to request yet another delay.

As it currently stands, providers will have to be able to exchange certain types of medical data with other providers and their patients by Nov. 2 or face fines for information blocking. EHR vendors will also have to be able to integrate with third-party apps through standardized application programming interfaces.

Providers will have to share admission, discharge and transfer (ADT) notifications tracking patient movement with one another by the spring of 2021. Other provisions requiring plans participating in federal programs to give patients free electronic access to their personal health data and make their provider directories available to current and potential enrollees also won’t kick in until spring 2021.

Providers applauded the deadline pushbacks, saying the moves would free up time and resources for pandemic preparedness, though the American Hospital Association thought the government could have been even more lenient.

That was at a time when there were only about 825,000 confirmed COVID-19 cases and about 45,000 deaths nationwide, mostly concentrated in early hotspots like New York City. Since then, amid a largely nonexistent federal response, the pandemic has become a virulent juggernaut with no signs of slowing down. To date, there are almost 7.1 million confirmed cases and 205,000 deaths, according to Johns Hopkins University’s coronavirus dashboard. The U.S. is averaging more than 43,000 new cases per day, up 16% from just one week ago.

And public health experts and epidemiologists have warned the situation is likely to worsen as the cold winter months approach and COVID-19 meets the flu season, potentially overloading providers.

This could increase the pressure on ONC and CMS to further delay compliance deadlines for the two information blocking rules. In a June letter to CMS, the AHA asked the government to reconsider implementing some of the interoperability requirements, including ADT notifications — a particular thorn in the side of providers — saying COVID-19 resource allocation would make compliance difficult.

But health IT experts have generally spoken out against delays. COVID-19 has highlighted systemic weaknesses in healthcare, including an inability for hospitals and health systems to quickly share data with one another and with public health agencies.

That’s stopped the government and private sector partners from getting a holistic snapshot of the pandemic, including confirmed cases, diagnostic test results, treatment outcomes and more, complicating efforts to allocate resources, undergo contact tracing or other public health responses.

“COVID proves a point. Ideally we would have had all of this three years earlier in time but, you know, we’re working on it,” Rucker said.

The administration faced fierce industry opposition in crafting the rules, especially from IT vendors concerned opening up data silos could threaten their business models. Detractors threw themselves into lobbying, warning of privacy concerns from giving third party companies access to healthcare records and pulling protected health information out of the umbrella of the HIPAA privacy law.

EHR giant Epic even threatened to sue HHS over the upcoming regulations, though the furor generally died down after they were finalized.

“We’ve had lobbying pressure all along here,” Rucker said. “Whenever you disrupt powerful economic forces in D.C., the town business is lobbying. So as you might imagine, things spring into action.”

Moving forward, however, Rucker is hopeful the rules will shepherd a new app economy into healthcare, fostering more digital health business models and streamlining ones that already exist, like telehealth.

“Think about the entire experience that surrounds it. How is the caregiver on the phone or video getting information on my background or do I have to reenter it? How are they getting my medication list? How are things like services, prescriptions, lab orders, diagnostic tests, how are they being ordered? How is follow-up being coordinated?” Rucker said. “All of those things really require robust interoperable APIs.”

The ONC head also expects large consumer brands, like Apple and Google, will get increasingly involved as patients turn to known entities to glean insights from their health data.

But, beyond regulations prodding industry toward interoperability, it’s also important that companies try to find ways to make patients’ health data relevant to them, and have them clamor for it, experts say. Some hope that could be a good aspect coming out of the pandemic — stronger consumer demand for knowledge about, and control of, their health.

“I’m quite supportive of the push. But there’s a pull also, and I think the pull is what we haven’t yet figured out,” Karen DeSalvo, ex ONC head under President Barack Obama and currently Google’s chief health officer, said at CB Insights.