Health leaders disappointed in what 21st Century Cures Act lacks

The latest iteration of the 21st Century Cures Act, released Wednesday, is seeing criticism from many healthcare organizations--not over what has been added to it, but because of what is still left out.

The legislation is set to be considered next week by the full House Committee on Energy and Commerce, it was announced today after a voice vote by the subcommittee. 

"Our time is now," subcommittee members Fred Upton (R-Mich.), Diana DeGette (D-Colo.), Joe Pitts (R-Pa.), Frank Pallone (D-N.J.), and Gene Green (D-Texas) said in a statement. "For more than a year we have been listening and diligently working on policies that we believe will truly make a difference in the lives of families and patients. ... In the coming days we will continue working to make improvements to this important bill and prepare for a full committee markup next week."

One new addition to Wednesday's version of the bill is language on interoperability of health information through electronic health records; this was left out of the previous updated draft released April 30.

The new version requires that electronic health records be interoperable by Jan. 1, 2018; Meaningful Use decertification would await those systems not meeting such a standard. Providers impacted by such an act would be eligible for hardship exemptions to Meaningful Use penalties of no less than 12 months and no more than five years, to be determined by the Department of Health and Human Services on a "case-by-case basis."

However, the College of Healthcare Information Management Executives is none too pleased with what was not included in the new interoperability section--patient identification. CHIME President and CEO Russell Branzell and Board Chair Charles Christian sent a letter earlier this week asking that better patient identification be included in the newest version, calling it "the most significant challenge" to safe health information exchange.

On Wednesday, once again, the organization asked that it be included.

"Interoperability is a complex, multifaceted problem that will only improve when we have a standardized approach for collecting and sharing data, but that can only occur once a patient has been positively identified," CHIME said in a statement emailed to FierceHealthIT. "Increasing access to patient data alone will not translate into better patient care. We would encourage the committee to emphasize both the need to increase access and exchange health information, along with the value of being able to use the data to improve care."

Much like CHIME, the American Telemedicine Association also was disappointed in what the bill left out--language on telehealth.

"It appears that the staff and members of the committee have once again been led by [the Centers for Medicare & Medicaid Services] and the Congressional Budget Office into asking for a study instead of taking real action," ATA CEO Jonathan Linkous said in a statement.

Linkous went on to call such studies "'snooze buttons' that allow CMS to delay any action for years." The ATA did express hope that Congress will adopt "at least a few measures" to expand access to telemedicine.

In addition to those criticisms, Bradley Merrill Thompson, an attorney with Epstein Becker Green who represents the CDS Coalition and other groups, called updated language pertaining to clinical decision support regulation for the Sensible Oversight for Technology Which Advances Regulatory Efficiency (SOFTWARE) bill too open-ended, in an email to FierceHealthIT.

"The bill does not create a roadmap for innovators to discern whether a given piece of software is regulated or not," Thompson said. "It simply provides some guidance to [the U.S. Food and Drug Administration] for it to make the decision. We need legislation that is self-executing, that provides the software development community with clear delineation as to what's in and what's out."

To learn more:
- here's the updated draft legislation (.pdf)
- read the ATA's statement

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