COVID-19 delays enforcement of federal interoperability rules

ONC, CMS enforcement discretion

Jeff Smith, vice president of public policy for the American Medical Informatics Association, described the delay as a thoughtful approach by ONC and CMS given the scope and severity of the pandemic.

Jeff Smith

"ONC and CMS, they're in a balancing act," Smith said. "On the one hand, the policies that are in both of those rules should facilitate the kind of interoperability we need during this pandemic. Having said that, the work that is necessary to get to that place is not inconsequential at a time when the focus has to be on managing this pandemic."

ONC and CMS spent more than a year crafting the interoperability rules in response to mandates drawn out in the 21st Century Cures Act for greater healthcare interoperability. The portion from CMS serves as a complement to the ONC rule.

ONC and CMS, they're in a balancing act.

Most of the components of the ONC rule will be delayed an additional three months after the initial compliance date, which varies depending on the requirement. CMS is delaying enforcement of most of the requirements in its patient access rule by six months, including its API requirements for healthcare organizations and insurers. For the ONC rule, compliance timelines begin once the rule is published to the Federal Register, which is scheduled for May 1.

Matthew Michela

Matthew Michela, CEO of medical image sharing company Life Image and a member of the Sequoia Project, which works with ONC on interoperability, said the decision to delay enforcement for healthcare systems was a practical one, as many are focused on COVID-19 response. However, he does not believe that practicality applies to health IT developers, such as EHR vendors, who have been granted the same delays.

"I would like to see a little bit more nuance in the delays here in the sense that I think, generally, healthcare IT organizations really don't need the delay," he said. "They really should continue to invest and innovate around these standards, creating patient access, APIs. Those organizations I think are largely fully capable and the technology work they're doing has been established in the roadmap business quarters ago."

OIG proposed rule

The enforcement delay from ONC and CMS was expected, but the proposed rule from OIG wasn't.

Smith believes the rule for civil money penalties proposed by OIG will give ONC's information blocking rule some teeth -- and it's something healthcare stakeholders are paying attention to. OIG is the enforcement arm for the interoperability rules and will oversee financial penalties for unsanctioned information blocking.

"People want to know what is the damage if there's a claim for information blocking, and what is the process to ascertain whether I really am blocking information or if I'm not," Smith said.

In its proposed rule, OIG outlines how it would determine information blocking violations and highlights priority cases for enforcement, such as if an information blocking incident caused patient harm, lasted a significant amount of time or impacted a provider's ability to provide care to patients.

In a press release, OIG said it will dovetail its enforcement with ONC's delay so that, at a minimum, enforcement would begin no sooner than compliance dates listed in ONC's final rule. OIG also plans to delay its enforcement for 60 days after its proposed rule is finalized.

Stakeholders have 60 days to submit comments regarding the proposed rule, although OIG notes it will monitor requests for extending the comment period due to COVID-19.