- The passage of the 21st Century Cures Act by the Senate early this week appears to be a done deal, but many of its provisions represent causes for concern for the head of one organization focused on supporting healthcare interoperability and health data exchange.*
*Editor's note: The Senate passed the 21st Century Cures Act by a strong 94-5 majority on December 7.
Following the passing of the bill by the House of Representatives last week, DirectTrust President & CEO David Kibbe, MD, MBA, raised an important question about what the provisions of the bill actually mean for federal health IT policy.**
“Are Congress, and the President, if he signs the Bill into law, pointing in a new policy direction or merely reaffirming, while seeking to fine tune and improve, the policies for EHRs and health IT of the recent past?” he inquired in a public statement after noting that the 21st Century Cure Act is “open to interpretation” as for its potential to change regulation of EHR and health IT use.
“To some observers, several of the bill's components appear to instigate a completely new infrastructure in advance of new policy-making directions,” he continued. “One of these is a mandate for new reporting requirements and an advisory apparatus funded with $15 million to develop new criteria that must be met by health IT developers. Another is the new network governance stakeholder group that would convene private and public sector partnerships to create a new framework and common agreements for interoperable exchange between networks.”
Kibbe’s organization has supported secure, interoperable health information exchange through the use of the health IT standard Direct, which comprises protocols for messaging and other health data exchange activities.
While Direct use has benefitted from inclusion in requirements for the EHR Incentive Programs, Kibbe claims the new legislation does not appear to push beyond meaningful use in its vision for developing health IT policy moving forward.
“A close reading of what these new conveners and policy advisory groups would be charged to carry out, however, sounds very familiar: aren’t these themes carried over from the last five years of what might be called the Meaningful Use era of health IT policy?” he added.
In his comments, Kibbe draws attention to several provisions of the bill that resemble the status quo set years before:
For example, ONC’s certification role over health IT isn’t replaced. Instead, it is broadened and deepened to enhance certification for ‘testing real world use of the technology for interoperability,’ along with other new responsibilities for measuring and reporting on the usability and value of these systems. We have a new definition of interoperable health IT, one that adds to the old the terms ‘complete access, exchange, and use of all electronically accessible health information…,’ and non-involvement with ‘information blocking.’ But here, too, these are less departures from the past than significant edits and amendments to what came before. Even the section of the bill that calls for a new network-of-networks trust agreement and a set of common policies is, in large part, an echo of the past: a rejuvenation of ONC’s HITECH-derived statutory responsibility to establish governmental process for the Nationwide Health Information Network—without, thankfully, reviving that moribund terminology.
According to the head of DirectTrust, the ability for the 21st Century Cures Act to effect change will come down how the new leaders of the Centers for Medicare & Medicaid Services (CMS), Office of the National Coordinator for Health Information Technology (ONC), and National Institute of Standards and Technology (NIST) implement its provisions and work with stakeholders in the private sector.
Good leadership could lead to advancement in health IT interoperability, value-based care, population health, etc. Conversely, poor leadership could prove a setback to progress in these areas over the past few years.
“This is one of those times when, in my opinion, leadership will really count a great deal,” Kibbe concluded.
**Editor's note: Kibbe told HealthITInteroperability.com that DirectTrust supports the bill and its provisions and "will work with HHS to implement them to the best of our abilities, believing that they are a sign of continuity and making improvements upon what has gone before."