House Passes 21st Century Cures Bill With Health IT Provisions

On Friday, the House voted 344-77 to advance the 21st Century Cures Act (HR 6), a broad bill that aims to accelerate the development and regulatory approval of medical innovations, The Hill reports (Sullivan/Ferris, The Hill, 7/10).

The Senate is writing its own version of the bill, and it is not yet clear what a compromise measure would include (Harris, “Shots,” NPR, 7/10). Bill supporters in the House hope to bring the compromise measure to a vote in the fall (The Hill, 7/10).

Bill Details

Over the next five years, the bill would provide an additional:

• $8.75 billion in mandatory funding to the NIH to bolster medical research (The Hill, 7/10); and
• $550 million in funding to FDA (Johnson, Modern Healthcare, 7/10).

Heath IT Provisions

The bill also includes several health IT and interoperability provisions.

For example, in January 2018, vendors would have to confirm that their EHR software complies with several interoperability provisions, including:

• Certain financial details on the pricing of transmitting data;
• Having application programming interfaces that provide instructions on how to access EHR data to outside users and developers; and
• Meeting HHS’ standard of allowing “everyday” data exchange.

Vendors that fail to comply with such standards would risk having their software decertified for use under the meaningful use program. Under the 2009 economic stimulus package, providers who demonstrate meaningful use of certified EHRs can qualify for Medicaid and Medicare incentive payments.

However, the bill gives HHS the authority to provide one- to five-year hardship exemptions to providers whose EHR software becomes decertified (iHealthBeat, 6/26).

Meanwhile, the bill also would:

• Authorize HHS’ inspector general to investigate allegations that companies or providers are engaging in information blocking by deliberately deterring the exchange of EHRs;
• Change patients’ rights relating to their health data;
• Clarify when providers are not required to obtain consent from patients to share patient data; and
• Require HHS to begin standardizing clinical trial registry data 18 months after enactment to assist with data sharing on enrollees and potential clinical trial participants (iHealthBeat, 5/14).

Comments

During debate on the bill on Thursday, some representatives praised the bill’s effect on the health IT sector, Politico‘s “Morning eHealth” reports.

For example, Rep. Frank Pallone (D-N.J.) spoke favorably of the bill’s interoperability sections and the SOFTWARE Act, which provides guidance on FDA oversight of health IT.

Rep. Marsha Blackburn (R-Tenn.), author of the SOFTWARE Act, said, “Data [are] not a drug or a device and it makes no sense to regulate it as such.” She noted that the section will keep FDA from over-regulating “the wonderful app[lications] that we use to make us healthy.”

In addition, Rep. Diana DeGette (D-Colo.) said that the bill would “encourage new disease registries” as well help “safe data-sharing and digital medicine” (Tahir/Pittman, “Morning eHealth,”Politico, 7/10).

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