Enforcement of interoperability rules to be relaxed to ease burden on providers

Providers are getting an additional six months to comply with new regulations aimed at improving data sharing.

Federal policymakers are relaxing enforcement of recently released data sharing rules and extending compliance timelines for some requirements due to the COVID-19 pandemic.

The Office of the National Coordinator for Health IT (ONC) and the Centers for Medicare & Medicaid Services (CMS) announced Tuesday a policy of enforcement discretion to allow compliance flexibilities regarding the implementation of the interoperability final rules.

On March 9, the Department of Health and Human Services (HHS) issued two widely anticipated rules, one each by ONC and CMS, that promote patient access to data and improved information sharing. The rules implement interoperability provisions of the bipartisan 21st Century Cures Act.

The rules promote greater data exchange among healthcare providers and ensure patients will have access to their personal medical records and claims data through application programming interfaces (APIs) on the device of their choosing, such as their smartphone.

RELATED: CMS' new interoperability rule requires major changes for payers, hospitals. Here are 6 key elements

ONC, CMS and the HHS Office of Inspector General (OIG) will continue to monitor the implementation landscape to determine whether further action is needed, the agencies said.

ONC's interoperability and information blocking rule will be published in the Federal Register on May 1, and ONC will not enforce provider electronic health record requirements for six months after the rule's publication. That means compliance with information blocking provisions and certification policy provisions goes into effect Nov. 2.

As part of the ONC rule, certified health IT developers are required to make available standardized APIs that will aid in patient access to their health information on a smartphone. ONC kept those timelines the same but said it would delay enforcement for an additional three months.

ONC published a timetable (PDF) of new compliance dates and timelines.

RELATED: Here are 6 ways the ONC's new rules for opening health record access will impact the industry

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

"To support that important work and the information sharing efforts we are already seeing, ONC intends to exercise enforcement discretion for three months at the end of certain ONC Health IT Certification Program compliance dates associated with the ONC Cures Act Final Rule to provide flexibility while ensuring the goals of the rule remain on track."

CMS is extending the implementation timeline for providers to share admission, discharge and transfer notifications as a condition of participation by an additional six months. That requirement will go into effect in the spring of 2021.

The agency also is pushing back certain payer interoperability requirements by six months.

CMS-regulated payers—specifically MA organizations, Medicaid fee-for-service programs, Medicaid managed care plans, CHIP fee-for-service programs and CHIP managed care entities—are required to provide patients access to their claims and encounter information, including cost, through a third-party app of their choosing. That requirement goes into effect January 1, 2021.

But CMS won't enforce those requirements for an additional six months, which means enforcement begins July 1, 2021.

"Today's action follows the extensive steps CMS has taken to ease the burden on the healthcare industry as it fights COVID-19. Now more than ever, patients need secure access to their healthcare data. Hospitals should be doing everything in their power to ensure that patients get appropriate follow-up care. Nevertheless, in a pandemic of this magnitude, flexibility is paramount for a healthcare system under siege by COVID-19. Our action today will provide hospitals an additional 6 months to implement the new requirements," said CMS Administrator Seema Verma.

RELATED: Payers, providers: HHS' interoperability timelines not realistic with coronavirus

The HHS OIG also released Tuesday a proposed rule outlining civil monetary penalties related to information blocking. In the rule, OIG proposes a maximum fine of $1 million per violation.

OIG said it would delay enforcement until 60 days after its final rule is released.

Some groups have pressured CMS and ONC to delay the rules amid the current health crisis. Payer and provider organizations have recently said the timelines to implement HHS' interoperability regulations are "troubling" and not realistic given the current evolving pandemic.

Other organizations, such as the Pew Charitable Trust, have called for federal policymakers to move forward with data sharing regulations in light of increased use of virtual care during the COVID-19 outbreak.

Jeff Smith, vice president of policy at the American Medical Informatics Association, tweeted that the timeline changes are "reasonable."

Ben Moscovitch, project director, health IT at The Pew Charitable Trusts, applauded ONC for finalizing the rule with minimal time changes. "On the whole, minimal timeframe changes. New criteria for standard APIs still at 24 months (with 3-month enforcement discretion added)," he tweeted.