A busy week of health IT policy and politics played out during the first week of August. For Washington observers, the week was a perfect mix of relaxed Hill Staff, new policy recommendations and a changing of the guard at ONC. Accelerating health information exchange, the Food and Drug Administration’s role in health IT and news of Dr. Mostashari’s departure round out this week’s edition of the Washington Debrief, covering what CIOs need to know from the week that was Aug. 5, 2013.
ONC Chief Announces Fall Departure; Washington Abuzz with Successor Rumors
The health IT world was sent in a tizzy last week on word that National Coordinator Dr. Farzad Mostashari would be stepping down from his post at ONC sometime this fall. Dr. Mostashari made the announcement in an email to staff where he recounted a short history of ONC – from Stage 1 and a staff of 32 to developing national standards for transport, vocabulary and content. “There are formidable challenges still ahead for our community, and for ONC. But none more difficult than what we have already accomplished,” Mostashari wrote. In a statement issued by CHIME CEO Russell Branzell and CHIME Board Chair George Hickman, SVP & CIO at Albany Medical Center, they commended the National Coordinator’s work to “lead our nation’s providers through the first gates of measured, meaningful use of electronic health records, and address in reality those initial standards that make our health information portable across the U.S. healthcare system. Today’s health delivery system is fundamentally different than it was five years ago when HITECH was passed, but it’s not because Congress simply passed a law,” they continued. “It’s because ONC and CMS, in partnership with the private sector, designed an implementation strategy that tried to align various stakeholders and make the spirit of HITECH a reality.”
Dr. Mostashari has not indicated what his next move will be, but the race to predict his successor has begun in true Washington style. Observers note that a new chief will need to be found quickly, as the beginning of Stage 2 is set for October for hospitals and recommendations for Stage 3 are expected early in 2014.
CMS, ONC Release Plans to Accelerate Health Info Exchange
In March, officials from CMS and ONC published a request for information, asking for thoughts on how government policies could promote health information exchange. Last week, officials unveiled results from that RFI along with a strategy that relies largely on incorporating exchange requirements into existing Medicare and Medicaid policies. “The overarching policy intent is to develop and implement a set of policies and programs that would encourage providers to routinely exchange health information through interoperable systems,” Dr. Farzad Mostashari said during a webinar, introducing the strategy. CMS Innovation Center Acting Director Patrick Conway said that CMS would leverage, Medicare, Medicaid, and the Basic Health Plan (BHP) requirements to spur data exchange. ONC said it would continue using multi-stakeholder approaches to developing standards, under the Standards and Interoperability (S&I) Framework, and it accelerate the alignment of electronic clinical quality measures, electronic decision support, and electronic reporting mechanisms for Medicare and Medicaid programs. Dr. Mostashari also said that ONC would do a better job communicating their standards development “roadmap” to provider and industry partners.
Much-Anticipated Recommendations Outline Possible Role for FDA in Regulating Health IT
After a summer of frantic meetings the Food and Drug Administration Safety and Innovation Act (FDASIA) workgroup issued preliminary recommendations to ONC’s Health IT Policy Committee last week. The top-level recommendation was that health IT should not be subject to the FDA’s pre-market approval requirements. The workgroup instead recommended that further efforts look to bolster post-market surveillance of health IT. The preliminary recommendations stated, “Substantial additional regulation of HIT beyond what is currently in place is not needed and would not be helpful, except for:
· Medical device data systems (MDDS)Medical device accessories;
· Certain forms of high risk clinical decision support; and
· Higher risk software use cases.
Additional recommendations included:
· Vendors should be required to list products which are considered to represent at least some risk and a “non-burdensome approach” should be developed for this;
· Better post-market surveillance of HIT is needed; and
o Standard formatting of involved reports
o Also post-implementation testing
o Approaches to allow aggregation of safety issues at the national level, including federal support to enable this
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