By a vote of 51-0, the House Energy and Commerce Committee on Thursday approved the 21st Century Cures Act bill, including health information technology provisions potentially impacting electronic health records interoperability, regulation of software as medical devices, and Medicare reimbursement policies for telemedicine.

“I’ve been on the committee for 28 years and I don’t think we’ve had a major bill that didn’t have somebody—usually me when we were in the minority—that voted no. That is an amazing accomplishment,” said Rep. Joe Barton (R-Tex.), the senior Republican and chairman emeritus of the House Energy and Commerce Committee. “This will change America. It will change the world—for the better. This bill will become law and it will last for decades.”

Next stop for the 21st Century Cures Act is the floor of the House of Representatives, which is expected to consider the bill next month. But the bill is not without controversy.

The legislation seeks to further EHR interoperability through enforcement mechanisms targeted at providers and vendors engaging in information blocking. However, the American Hospital Association has voiced its opposition to these measures.

Also See: Info Blocking Gains Prominence as Interoperability Challenge

In a May 18 letter to Rep. Fred Upton (R-Mich.), chair of the Energy and Commerce Committee, AHA expressed its concern about the 21st Century Cures Act’s “heavy-handed and duplicative enforcement mechanisms contemplated for providers” which “could have significant unintended consequences, including undermining new models of care and setting up an environment where well-intentioned providers face significant penalties for small mistakes.”

Specifically, on the provider side, AHA believes that the use of Medicare fraud and abuse mechanisms, such as investigations by the Office of the Inspector General, imposition of civil monetary penalties or exclusion from the Medicare program, is unnecessary and inappropriate.

“We recommend that you use the existing structures of the meaningful use program to promote information sharing,” states the letter. “To that end, the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) already has established a new requirement for healthcare providers to make an affirmative attestation to the government that they have not taken steps to limit the interoperability of their electronic health records as part of the requirements of meaningful use. As currently drafted, the Cures act would add an attestation that a provider has not engaged in information blocking. We believe that having both of these attestations is duplicative and unnecessary.”

In addition, AHA expressed concern that the definition of information blocking included in the 21st Century Cures Act is “overly broad and could result in reasonable business practices or customization of software systems leading to charges of Medicare fraud.” AHA seeks refinement of the definition in such a way that “prevents true information blocking without criminalizing actions that are needed to establish a solid information system to support good care and new models of care.”

Language in the bill also directs the Office of the National Coordinator for Health IT to certify only EHR products that meet meaningful use program standards and do not block health information exchange, while mandating that ONC take steps to decertify EHR products that block sharing.

While AHA said it appreciates lawmakers’ intent to hold vendors accountable for the design and marketing of interoperable products, the association argues that decertification as a sanction for vendors that engage in information blocking “would be disruptive to hospitals and physicians that have invested in and deployed an EHR that is later decertified.”

AHA supports inclusion of provider protections against meaningful use penalties if their EHR is decertified. “We appreciate, that those protections may last for more than one year, as it takes a hospital or other provider considerable time to identify a new EHR, contract for it, be added to the vendor queue, conduct the installation and ramp back up to meet the meaningful use performance requirements,” states the letter. The association notes that for complex hospital information systems the process can take up to two or three years to complete.

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