Health IT stakeholders calling for ONC, CMS to 'go back to the drawing board' on interoperability rules

doctor with tablet
Some industry groups say the proposed interoperability rules are so ambiguous and broad they need to be scrapped entirely and rewritten. (GettyImages)

The Health Innovation Alliance is calling for the recently proposed interoperability rules to be scrapped and rewritten.

Formerly called Health IT Now, the group says the rules as currently drafted leave too many loopholes for information blocking to occur and said the Office of the National Coordinator for Health IT (ONC) is overstepping its regulatory authority.

"We think at a core level the rules do not work, they should be rescinded, and ONC should go back to the drawing board to clarify with specificity how this is going to work so the marketplace can advance and innovation can continue to provide products to patients and others to make healthcare work better," said Joel White, executive director of the Health Innovation Alliance.

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He was speaking on a call with reporters Thursday organized by the Health Innovation Alliance, which represents 75 healthcare and technology organizations including Aetna, IBM, Athenahealth and Teladoc. The call also included other industry organizations with serious concerns about the proposed interoperability rules, including the American Academy of Ophthalmology, the Association of Clinical Research Organizations, the Electronic Health Record (EHR) Association and the Behavioral Health Information Technology Coalition.

These groups want federal healthcare policymakers to make major revisions to the proposed rules before finalizing them and also say the rules exceed the mandate of the 21st Century Cures Act and go far beyond the intent of Congress.

RELATED: AMIA says ONC rule doesn't go far enough on patients' data access

ONC unveiled the proposed rule (PDF) back in February focused on implementing health IT provisions in the Cures Act. The rule calls on the healthcare industry to adopt Fast Healthcare Interoperability Resources as the standard for application programming interfaces while also proposing a requirement that patients must be able to electronically access all of their data through an “electronic health information” export.

The rule additionally seeks to implement the information blocking provisions of the Cures Act, proposing seven exceptions to the definition of information blocking, which refers to the act of intentionally interfering with the sharing of electronic health information.

CMS also released a proposed rule (PDF) taking aim at data blocking. The comment period for both rules ends on June 3.

Several prominent industry groups including the College of Healthcare Information Management Executives and the American Medical Informatics Association have asked ONC to issue an interim rule rather than a final rule to provide more time for industry stakeholders to give feedback.

Leading lawmakers, including Sen. Lamar Alexander, R-Tennessee, chairman of the Senate HELP committee, have urged ONC and Centers for Medicare & Medicaid Services (CMS) officials to consider delaying the implementation of the interoperability rules and taking a more phased-in approach, voicing concerns about the burden on providers and vendors along with data privacy risks. 

The concerns

A shared concern among many of the industry groups speaking during the media call Thursday is that the seven exceptions to information blocking will become the rule as there are too many loopholes, White said.

"The seven exceptions are very broadly drafted, are unclear, and are subject to situational and circumstantial interpretation that will lead to different interpretations from different people at different points in time," White said, noting that there will likely be extensive litigation before the industry sees any meaningful enforcement.

"These rules provide less clarity on the rules of the road, more confusion and more opportunity to block information," he said, adding that the information blocking rules need to be clarified and strengthened with more specificity.

White said his organization also has serious concerns about the definitions around electronic health information and health information networks as proposed in the information blocking rule. The broad definitions could have chilling effects on innovation and significantly burden organizations that were not intended to fall under the information blocking provisions, he said.

According to White, the rule would apply to social networks such as Facebook, Twitter and Google as well as cloud-based service providers, community-based support organizations and almost any system where electronic information is exchanged. It will also draw in community-based support organizations who may hold health information but whose main activity is not providing clinical services, such as Meals on Wheels, Area Agencies on Aging and disease support groups, he said.

"At a more core level, ONC is acting more as a regulator than a coordinator," White said.

RELATED: Lawmakers call for delay in implementing interoperability rules

Allscripts' vice president of health policy Leigh Burchell, who was speaking on behalf of the EHR Association as its chair of public policy, said on the call that the tremendously broad reach of ONC's proposed rule goes far beyond congressional intent.

"The definitions are very broad and inclusive and they pull in stakeholders that Congress did not intend to pull into this," she said. 

The language around the seven exceptions to information blocking is too ambiguous and allows too much room for discretion, and that makes it problematic for affected stakeholders who potentially face penalties of as much as $1 million per infraction, she said.

In a blog post, the EHR Association also complained about concepts in ONC's proposed rule around compulsory licensing terms for new intellectual property and limitations on profit from developing new technologies. 

According to the organization, the proposed rule “requires EHR developers and others to share their intellectual property with anyone who asks under Fair, Reasonable and Non-Discriminatory,” or FRAND, terms.

"This will prove to be a disincentive for people investing in robust, exciting new developments because of what it will do to the business opportunity. This will chill innovation and interest in entering the space for those with new emerging technologies," Burchell said during the call.

RELATED: CHIME urges CMS, ONC to give providers 3 years to comply with interoperability rules

Al Guida, president and CEO of Guide Consulting and speaking on behalf of the Behavioral Health Information Technology Coalition, said the proposed rules set up behavioral health providers to fail because most providers do not have the health IT resources to comply with the requirements.

Behavioral health, mental health and substance abuse treatment professionals and facilities were not included as eligible for federal funding to adopt EHRs under the HITECH Act. As a result, behavioral health and mental health providers have lagged considerably in the adoption of health IT and EHRs.

"In our view, the information blocking and interoperability rules are divorced from reality," Guida said. "Psychiatric hospitals, as a condition of participation in Medicare, will have to generate admit, discharge and transfer (ADT) electronic notifications. In the opioid use space, ONC is proposing five existing certification criteria as part of the 2015 health IT certification around addiction treatment and medicated-assisted treatment. But we don’t have the resources to adhere to those requirements and it sets us up for failure."

Guida is calling on federal healthcare policy leaders to implement a higher reimbursement rate or lump sum payment for addiction treatment and mental health providers in order to acquire the health IT systems necessary to adhere to the new requirements contained in the proposed rules. 

So far, ONC and CMS officials have indicated no intention of delaying the rules despite many calls from industry stakeholders to allow more opportunity to comment. "The sense is that there is so much unknown and undefined and there are those suggesting alternatives that might be a better fit for the goals of the legislation," Burchell said.

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