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Interoperability Implications of 21st Century Cures Bill

The likely passing of the 21st Century Cures Act will lead to changes in the federal government's approach to interoperability in healthcare.

By Kyle Murphy, PhD

- After a year and half of political discussion, Congress is preparing to vote on and likely in favor of the 21st Century Cures Act, a bill with bipartisan support that has serious implications for healthcare interoperability.*

Interoperability in the 21st Century Cures Act

*Editor's note: The Senate passed the 21st Century Cures Act by a strong 94-5 majority on December 7.

As early as today, the House of Representatives could vote on a revised version of the bill released earlier this week, according to multiple sources. In total, five sections of the 996-paged bill include mentions of interoperability.

First is the section on “Transparent Reporting on Usability, Security, and Functionality,” which notes that a condition of health IT certification for 21st Century Cures programs that systems do not prohibit or restrict their interoperability with other technology among other prohibitions and restrictions relative to health IT usability, security, and information exchange.

The bill names the EHR Incentive Programs, Merit-based Incentive Payment Systems, Alternative Payment Models, and Hospital Value-Based Purchasing Program, and other value-based care programs as necessary elements to be addressed by the Department of Health & Human Services (HHS) in developing a strategy for assisting providing in care quality improvements in amended changes to the Health Information Technology for Economic and Clinical Health Act.

Moreover, testing for health IT certification will include a demonstration of real-world interoperability along with publishing of application programming interfaces “that allows health information from such technology to be accessed, exchanged, and used without special effort through the use of application programming interfaces or successor technology or standards,” the bill states.

Regarding development of EHR reporting program criteria (i.e., meaningful use requirements), HHS must include interoperability as a measure. Additionally, independent entities looking to receive grants, contracts, or agreements under the program will receive priority  for expertise in health IT usability, interoperability, and security.

Section 4003 provides the proposed bill’s definition of interoperability, which has the following three characteristics:

(A) enables the secure exchange of electronic health information with, and use of electronic health information from, other health information technology without special effort on the part of the user;

(B) allows for complete access, exchange, and use of all electronically accessible health information for authorized use under applicable State or Federal law; and

(C) does not constitute information blocking as defined in section 3022(a).

The section, likewise, mandates support for “interoperable network exchange” to be spearheaded by the Office of the National Coordinator for Health Information Technology in collaboration with National Institute of Standards and Technology and other divisions of HHS. The work will include establishing and publishing details about a trusted exchange framework as well as publishing a directory of participating health information networks and rules for these networks to apply.

A new Health Information Technology Advisory Committee to replace the existing Health IT Policy and Standards Committees for advising ONC on the development of a policy framework “to advance an interoperable health information technology infrastructure.” What’s more, health IT interoperability is listed as an additional priority target area for the HIT Advisory Committee when new circumstance arise that impact this capability.

This committee will also have the responsibility for submitting annual progress reports of interoperability advancements to HHS and Congress, including recommendations for realizing improvement to interoperability in the healthcare industry.

As for ONC, the federal agency must implement a standardized process for receiving complaints about health IT not being interoperable or responsible for information blocking.

As Sections 23001 and 25005 of the 21st Century Cures Act, the bill requires HHS to designate standards for health data exchange to improve interoperability.

What remains unclear is how the provisions for interoperability in the proposed bill will impact plans currently in motion within HHS to transition to value-based care, such as the Quality Payment Program set to begin January 1.

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