Whither ONC?

As budget time looms, so do questions: inquisitive legislators, organizational restructuring, staff departures and a gameplan for interoperability
By Mike Miliard
03:16 PM

Increasingly, it seems Capitol Hill may be starting to question the long-term mission of the Office of the National Coordinator for Health Information Technology.

With stacks of hefty incentive checks already mailed out for Stage 1 meaningful use – $23.7 billion as of June – but providers clearly struggling with the measures of Stage 2, the agency appears to be at something of an impasse. 

Nationwide interoperability remains maddeningly – if unsurprisingly – elusive, even as National Coordinator Karen DeSalvo, MD, has restructured ONC to better strive for that goal and seems to have redoubled the agency's efforts to get there. (Well, sometime within the next 10 years, at least.)

Meanwhile, some senators and representatives are starting to ask some pointed questions about its mission and mandate.

Add to that a couple high-profile departures in July – Chief Privacy Officer Joy Pritts and Office of Consumer eHealth Director Lygeia Ricciardi – and it's fair to ask what the future holds for an agency that's done so much to shape the recent past. 

Money earmarked for health IT by the American Recovery and Reinvestment Act in 2009 was never going to last forever, of course. And so, this spring, DeSalvo announced plans for a rethinking of the agency's hierarchy as it starts to "pivot" away from its first, more well-funded task – helping foster electronic health record adoption – and moves toward the tricky "next chapter" of interoperability.

"The HITECH Act's health IT infrastructure and program investments are ending and it is our responsibility to take this opportunity to reshape our agency to be as efficient and effective as possible, never losing sight of our primary accountability – the people of America," DeSalvo explained. "Now it is time to begin the next chapter to promote interoperable health IT solutions that support the ultimate goal of better health for all."

On May 30, DeSalvo unveiled a "flatter and more accountable reporting structure" that she hoped would be more conducive to priorities such as patient safety, consumer engagement and interoperability. She announced 10 new offices within ONC – Office of the Chief Scientist, Office of Policy, Office of Care Transformation, Office of Standards and Technology, etc. – that would help steer the way toward the agency's next phase.

(It was announced that one of those, Office of the Chief Privacy Officer, was to be headed by Pritts; just weeks later news broke that she'd be stepping down from her post. "Joy made it clear to me and the Secretary that she was committed to seeing me through my beginning tenure as National Coordinator, and has been an invaluable advisor to me over the last 5 months," said DeSalvo in a press statement.)

Its staff restructuring notwithstanding, some in Congress have begun to question ONC's mission, now that HITECH is in the rearview mirror. As our colleague, Government Health IT Editor Tom Sullivan, reported, on June 3, DeSalvo received a letter from the House Energy and Commerce Committee, asking her to respond to four points:

  1. When the authorization for the Medicare and Medicaid Incentive program expires, under what statutory authority does ONC believe it is able to regulate health IT and electronic health records, particularly in (but not limited to) non-meaningful use areas?
  2. The FDA is provided with the authority to regulate medical devices by the Federal Food, Drug and Cosmetic Act. What similar authority does ONC point to, going forward, to participate in regulatory activities in coordination with the FDA and FCC?
  3. To what extent does ONC's notice of proposed rulemaking on 2015 EHR certification represents a broader shift in focus from coordination and promoting efforts related to interoperability, privacy and security, and quality reporting criteria, to the regulation of data collection, functionality requirements, and other areas where market forces are more likely to promote innovation and efficiency?
  4. What role does ONC plan to play moving forward on issues including, but not limited to, health IT safety and EHR certification requirements? How will the recommendations of ONC's Federal Advisory Committees guide these plans? Will ONC's role be limited to the scope of these recommendations?

Meanwhile, in July, the Senate Appropriations Committee, in laying out a potential 2015 for the Department of Health and Human Services, suggested earmarking just $61 million for ONC – less than the $75 million that had been requested.

Moreover, it did so with proverbial strings attached. The committee averred that ONC should name and shame the vendors that stand in the way of interoperability.

"ONC should use its authority to certify only those products that ... do not block health information exchange," according to the report. "ONC should take steps to decertify products that proactively block the sharing of information."

Clearly, this is a message to which the agency is receptive. DeSalvo has put interoperability – real, nationwide, no-nonsense data liquidity – front and center since she took the reins, most notably with the framework put out by ONC in June, titled "Connecting Health and Care for the Nation: A 10-Year Vision to Achieve an Interoperable Health IT Infrastructure."

"We have heard loudly and clearly that interoperability is a national priority," DeSalvo writes. "We also see that there is a tremendous opportunity to move swiftly now." 

Only in Washington does addressing a problem "now" necessitate a "10-year vision" to see it through.

But it's true, as DeSalvo writes, that achieving interoperability s no easy task, requiring "a strategic and focused effort by the federal government in collaboration with state, tribal, and local governments and" – here, perhaps, is the trickiest part – "the private sector."  

ONC may be entering uncharted waters, but that goal – getting the vendors and providers to play nice with their technology and their data – has to be atop its to-do list. As HIMSS Vice President of Government Relations Tom Leary told Healthcare IT News last month, "interoperability is what their main concern is right now: making the certification and the standards development processes simpler, so we can see tangible result."

One wonders, though, what sort of sway DeSalvo has nowadays -- without $27 billion to wave around anymore -- compared to her predecessors.

"What she's saying to me is she has stakeholders and feds saying, 'Get to the core of the title of your position: Coordinate,'" says Leary. "You don't have the dollars to wave around, but you do have the mandate from Congress, as described in the law that creates the office. I think that's what she has to stand on: A request from other federal agencies and an expectation from stakeholders that they will lead."