The Health Innovation Alliance called on the CMS and the Office of the National Coordinator for Health Information Technology to rescind their companion interoperability and information-blocking rules, arguing they would cause confusion and represent an overreach of the ONC's regulatory authority.
The public comment period for the CMS' and the ONC's long-awaited proposed rules, which the agencies released in February, close Monday. The rules outline how regulators will require providers and insurers to share medical data with patients, as well as steps to discourage healthcare organizations from creating barriers that inhibit health data exchange.
But the Health Innovation Alliance, formerly Health IT Now which represents insurers, patient groups, trade organizations and technology vendors, argued the rule would make information-blocking worse.
"ONC and CMS ought to go back to the drawing board to clarify with specificity how this is going to work," Joel White, the group's executive director, said on a press call Thursday.
The Health Innovation Alliance is calling for the CMS and the ONC to rescind the rules and reissue them as separate, smaller proposals that tackle specific elements of information-blocking and interoperability. The group suggested the ONC issue an initial rule that defines information-blocking and its exceptions, followed by a rule that outlines IT certification criteria.
Most of the criticisms the group has voiced relate to the ONC's rule.
As it stands, the ONC's rule outlines seven exceptions where information-blocking is acceptable for providers, such as if they're engaging in practices to prevent patient harm. But these notes are too broad, and leave room for many organizations to claim exception, White said.
White took issue with exceptions for responding to requests that are "infeasible" or that would "impose a substantial burden," which he said were subjective and had the potential to allow any entity to argue it meets the exception criteria. The ultimate concern, he said, is that this ambiguity would leave the court system to figure out what meets the criteria and what doesn't.
Dr. William Rich, the American Academy of Ophthalmology's medical director of health policy, also voiced concerns about the exceptions included in the ONC's rule.
The American Academy of Ophthalmology is a member of the Health Innovation Alliance.
"We totally, totally agree that the exceptions in this proposed rule leave so many loopholes, we're not sure that they actually do anything to help with interoperability at all," Rich said on the call. "They have to be pulled back and redone."
Another of the Health Innovation Alliance's core concerns involved the ONC's definitions of electronic health information and health information networks, which the group says are broad enough to include a number of companies that facilitate the exchange of personal health information today—such as social networks like Facebook.
This would eventually lead the ONC to begin acting more as a "regulator," and less as a "coordinator," according to White.
Leigh Burchell, vice president of health policy at Allscripts and chair of public policy at the EHR Association, agreed the ONC's rule is "overly broad and far exceeds congressional intent." She specified that she was speaking on behalf of the EHR Association, and not Allscripts, on the call.
The EHR Association has not called for the ONC to rescind its proposal, and has not yet submitted comments on the rules to the CMS or the ONC.
"There is so much ambiguous terminology used, words like 'reasonable,' 'as soon as possible,'" Burchell said of the information-blocking exceptions. "We would strongly prefer a clarification of terms. Tell us what is a reasonable timeframe for response to a certain request, for example. We're going to need significantly more specificity."
The Health Innovation Alliance isn't the only group calling for more time before the CMS and the ONC finalize their proposed rules.
The College of Healthcare Information Management Executives, for example, has recommended the CMS and the ONC release interim final rules.
"Given the magnitude of changes encompassed in these rules, CMS and ONC should publishing interim final rules rather than final rules to allow additional opportunity for stakeholder comments," CHIME wrote in a letter to the agencies dated May 15.