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HHS Grants More Time for Interoperability Compliance


Providers and vendors receive an extended timeline for data sharing and health IT certification.

In response to calls throughout the healthcare industry that the COVID-19 pandemic is monopolizing resources that would ordinarily be used to fall in line with federal regulations, the Department of Health & Human Services released plans Tuesday to push back the timeline for enforcing its recently published rules on interoperability and data blocking.

Via a statement, the Centers for Medicare & Medicaid Services (CMS) announced it’s giving providers six more months to be sure they’re following the new rules designed to improve data sharing. Additionally, the Office of the National Coordinator (ONC) has granted vendors three more months to ensure compliance with the health IT certification program.

“ONC remains committed to ensuring that patients and providers can access electronic health information when and where it matters most,” said Don Rucker, M.D., ONC chief, in the written statement. “During this critical time, we understand that resources need to be focused on fighting the COVID-19 pandemic.”

CMS Administrator Seema Verma reiterated the importance of the move at this time. Although patients and healthcare facilities need secure access to health data, including imaging, the agency recognizes other priorities are taking precedence.

“In a pandemic of this magnitude, flexibility is paramount for a healthcare system under siege by COVID-19,” she said, noting that CMS’s actions are intended to ease the burden on the healthcare system overall.

In the weeks after the ONC released the regulations – and its January 2021 deadline – many in healthcare, including those focused on radiology and imaging needs, have expressed concern about whether providers, facilities, and vendors would be able to effectively comply. Based on the published rule, the agency is set to require all images, imaging information, and imaging elements that can be considered electronic health information must be stored in a manner and made available for transfer between medical institutions.

The measure also prohibits information blocking, in essence knocking down any anti-competitive behaviors that prevent patient data from seamlessly flowing between systems designed by different vendors. Any information blocking violation could result in a $1 million fine per incident.

Related Content: COVID-19 Both Shifts Focus Away From And Highlights Need For Interoperability

What the Delay Means

Although there’s extra time added to the clock, hospitals and IT vendors shouldn’t look at it as a free gift, said Matthew Michela, president and chief executive officer for medical image exchange company Life Image. Instead, he recommended, all parties should view it as a chance to continue down the path toward interoperability at a pace that is sustainable during the outbreak without fear that the federal government will levy hefty punishment for not being able to comply earlier.

“The government is being reasonable in the sense that they’re telling people to continue working on interoperability, but we don’t know what the world is going to look like in three, six, or nine months with COVID-19,” he said. “They recognize that, as much as we all would hope, interoperability is going to require significant effort in this environment.”

He noted that the government has reserved the right to issue some type of punishment to parties it believes are acting as bad players.

And, as providers and facilities continue to work toward more formalized interoperability that falls within HIPAA guidelines, Michela said, CMS has relaxed the restrictions on existing tools that make data sharing, image transfer, and communication easier as providers are being asked to work remotely and patients are receiving care through telehealth avenues. For example, in a pre-COVID-19 world, FaceTime or Zoom would never have been considered appropriate platforms for patient care. But, now, in an effort to meet existing and ongoing needs, these avenues are being used extensively.

“Patient care comes first, and patients have a right to access their data,” he said. “So, if a provider is talking to a patient on Zoom, they’re turning their camera around to the monitor in their office and showing the patient his or her images live and in-the-moment.”

It’s a temporary solution to an ongoing issue, but it’s a stop-gap measure that is meeting current interoperability needs.

How Should You Fill the Extra Time?

The postponed deadline isn’t a reprieve, Michela cautioned, and it’s not the time to put any interoperability work you’re doing on the backburner. Keep going at a pace that is currently sustainable based upon the resources you can feasibly allocate to the effort.

Above all else, he said, if you haven’t already, select a medical image exchange vendor who had a proven track record before the viral outbreak.

“There’s a lot of smoke and mirrors out there – a lot of charlatans in the space who will over-promise and under-deliver,” he warned. “Be sure to do your due diligence in selecting a vendor or you could find that it takes you several business quarters to recoup lost ground.”

Remember that the perfect interoperability solution likely doesn’t exist. If you find a solution that offers 80 percent of what you’re looking for, move forward with it and focus on achieving the remaining 20 percent over time, he advised. And, routinely consult the road map your institution has created for interoperability. Frequent check-ins can ensure you’ll stay on the right track as you continue to navigate the added patient care pressure of COVID-19.

“Although it’s technically an additional three-to-six months of time, facilities might realistically get a few extra weeks of advantage depending on where they are in the country and the stage of disease management they’re in,” Michela said. “But, if they continue to tackle small tasks, they’ll be able to use their time wisely in a very uncertain world.”

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