ONC, CMS proposed rules continue to come under fire from stakeholders

The Office of the National Coordinator for Health IT and the Centers for Medicare and Medicaid Services should scrap their proposed rules on interoperability and start over.

That’s the contention of the Health Innovation Alliance (formerly Health IT Now), a coalition of patient groups, provider organizations, employers and payers.

Earlier this year, ONC issued a proposed rule—along with a companion rule from CMS—intended to make electronic health information accessible to both patients and providers. However, stakeholders have questioned whether the aims are achievable as the rules are currently written and within the proposed timelines.

In particular, ONC’s proposed rule seeks to implement the information blocking provisions of the 21st Century Cures Act and includes seven exceptions to the definition of information blocking—the act of intentionally interfering with the sharing of electronic health information.

“We are fundamentally opposed to information blocking, but we think—at a core level—the rules do not work. They should be rescinded, and ONC and CMS ought to go back to the drawing board,” said Joel White, executive director of the Health Innovation Alliance, on Thursday during a conference call.

According to White, the Health Innovation Alliance is concerned that the seven exceptions to the definition of information blocking are “very broadly drafted” by ONC and unclear. “They’re subject to situational and circumstantial interpretations,” he added, contending that it will only lead to “more confusion and more opportunities to block information.”

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Bill Rich, MD, medical director of health policy for the American Academy of Ophthalmology, agreed with White that the seven exceptions to the definition of information blocking in the proposed rule effectively create “so many loopholes” that would be counterproductive to improving interoperability. “They have to be pulled back and redone,” said Rich.

For its part, the HIMSS Electronic Health Record Association contends that the ONC proposed rule exceeds the mandate of the 21st Century Cures Act.

“We think the rule is overly broad and far exceeds Congressional intent,” commented Leigh Burchell, chair of public policy at EHRA and vice president of health policy for Allscripts, an EHR vendor.

Burchell made the case that the definitions of “interoperability elements” and “electronic health information” in ONC’s proposed rule are very broad and inclusive. “They pull in stakeholders who I do not believe Congress intended,” she added. “They pull in a wide range of products that I think are outside of the intent.”

Also See: EHRA says ONC’s proposed interoperability rule needs major revisions

White commented that ONC is “acting more as a regulator than a coordinator” of health IT—which he believes is problematic.

Likewise, Doug Peddicord, executive director of the Association of Clinical Research Organizations, described ONC’s proposed rule as “an example of regulatory overreach.”

According to Burchell, one of the stated goals of the proposed rule from ONC is to foster healthcare technology innovation. However, she contends that if the rule were to be finalized in its current form, it would actually “chill” innovation.

Despite growing criticism of its proposed rule from stakeholders, ONC appears to be taking it all in stride.

“We have received a wide range of comments—so far—from interested stakeholders and individuals who are negatively impacted by the lack of interoperability in healthcare,” said an agency spokesperson. “We look forward to receiving even more comments by the time the deadline ends on Monday.”

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