Interoperability Provisions Added to 21st Century Cures Draft Bill

May 14, 2015 in News

On Wednesday, the House Energy and Commerce Committee released an updated draft of the 21st Century Cures Act, which includes stiff penalties for electronic health record vendors that impede data sharing, Modern Healthcare reports (Tahir, Modern Healthcare, 5/13).

On Thursday, the House Energy and Commerce health subcommittee approved the draft bill by voice vote, sending it on to the full committee (Sullivan, The Hill, 5/14).

Committee Chair Fred Upton (R-Mich.) said he expects the draft bill likely will be marked up by the full committee next week (Owens, National Journal, 5/13).

Background

In January, Upton and Rep. Diana DeGette (D-Colo.) unveiled a discussion draft for the “21st Century Cures” initiative. While the discussion draft focused largely on FDA and safeguarding medical device innovations, it contained several health IT-related proposals.

In April, the committee released draft legislation with provisions to alter FDA’s oversight of health software products, but left out provisions on interoperability and telehealth (iHealthBeat, 4/30).

Updated Interoperability Provisions

According to AHA News, the new draft bill filled placeholders for several provisions, including those related to interoperability (AHA News, 5/13).

Under the new draft:

  • HHS would receive $10 million to work with a “charter organization” to create metrics to evaluate the state of interoperability within the U.S. health care system;
  • In July 2016, officials would release a report detailing whether the interoperability has been achieved and the extent to which EHR vendors’ software is cable of fulfilling the mission of interoperability; and
  • On Dec. 31, 2017, HHS would release a report detailing whether certain vendors’ EHR software was in compliance with particular interoperability certification requirements.

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 (Modern Healthcare, 5/13).

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 (Pittman/Allen, “Morning eHealth,” Politico, 5/14).

However, the bill gives HHS the authority to provide one- to five-year hardship exemptions to providers whose EHR software becomes decertified (Modern Healthcare, 5/13).

Other Health IT Provisions

Meanwhile, the draft 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 (Zanona, CQ News, 5/13);
  • Change patients’ rights relating to their health data;
  • Clarify when providers are not required to obtain consent from patients to share patient data (Modern Healthcare, 5/13); 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 (Mershon, “Pulse,” Politico, 5/14).

According to “Morning eHealth,” the revised draft legislation still lacks language to expand Medicare beneficiaries’ access to telehealth, but it does call for studies of such services (“Morning eHealth,” Politico, 5/14).

Reaction

Jeff Smith, senior policy adviser at the College of Healthcare Information Management Executives, said that while it is still too early to determine the exact implications of the draft bill, his “first take is that it’s improved.”

Dan Haley, vice president of government and regulatory affairs at athenahealth, said he was “pleased by the [bill's] focus on information blocking and the teeth given [to] those provisions” (Modern Healthcare, 5/13). He added, “Congressional recognition of the reality of information blocking practices, and the provisions of the draft that would empower regulators to do something about it, will do more than anything else to shake the ecosystem out of its siloed status quo.”

In addition, EHR vendor Cerner said that it supported decertification as a consequence for failing to achieve interoperability (“Morning eHealth,” Politico, 5/14).

The Federation of American Hospitals also expressed its support for various health IT provisions of the draft bill, including those to strengthen interoperability. In addition, FAH said it was looking forward to future language on expanding telehealth services, urging lawmakers to include both Medicare and Medicaid in the new policy (FAH letter, 5/13).

While the American Hospital Association applauded the revised bill for its efforts to remove barriers to interoperability, the group raised concerns about data security.

In a letter, AHA wrote, “We urge the committee to ensure an appropriate level of protection for the security, integrity and accessibility of these data” (Snell, Health IT Security, 5/13).

AHA also urged the committee to:

  • Expand the types of telehealth covered by Medicare; and
  • Remove “originating site” requirements for Medicare coverage of such services (AHA News, 5/12).

Meanwhile, the American Telemedicine Association said that it was disappointed by the draft bill’s lack of major telehealth provisions.

ATA CEO Jonathan Linkous said the proposed telehealth studies in the measure “are ‘snooze buttons’ that allow CMS to delay any action for years” (ATA release, 5/13).

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