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Wednesday, June 4, 2014

Whither ONC?

ONC's structure gets flatter as its $2B stimulus appropriation ends
By Joseph Conn 

It should have come as little surprise that Dr. Karen DeSalvo, in announcing last week a reorganization of the Office of the National Coordinator for Health Information Technology, said she was aiming for a “flatter” reporting structure.

One reason for the reorg is obvious. A massive bulge in ONC funding is deflating because most of the $2 billion that was directly appropriated to the ONC by Congress in 2009 for health IT programs under the American Recovery and Reinvestment Act has been spent over the past four years. The appropriation was part of the economic stimulus during the Great Recession.

DeSalvo, in a recent memo to her staff, noted that the ARRA'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.” There were no layoffs with the reorganization; the ONC head count remains at 191 full-time equivalents.

Back in February, in an on-camera interview soon after her appointment to head the ONC, DeSalvo talked about operating with less money than her two immediate predecessors, Drs. David Blumenthal and Farzad Mostashari, both beneficiaries of ARRA funds...

Most of that stimulus law money went to health IT workforce development programs, the Beacon Community program, state health information exchanges, higher education in health IT and the regional health IT extension center program.

Fifty-five of the 60 extension centers in the first two rounds of grants have applied for and received permission from the ONC to keep spending remnants of their funds, according to the ONC. Two other RECs in the third round of grants have requests pending for similar spending extensions. But in no case will spending continue after five years from their original grant date, the ONC maintains.

Grants for the REC program totaled $688 million or a little more than one-third of the ONC's appropriation under the stimulus law.

DeSalvo, a professed fan of the RECs, has said she'd like to see their work continue.

The original plan called for the popular RECs to be financially self-sustaining after four years, but a program to extend federal financial support to them has not materialized.

In March, Mat Kendall, who headed the ONC's REC program since its inception in 2010, stepped down as director of the Office of Provider Adoption Support.

That office did not make the cut as DeSalvo's reorganization plan pared the ONC structure from 17 offices and suboffices to 10. Those duties now fall under the new Office of Programs.

According to a survey of executives of 37 RECs published in April and conducted by the Healthcare Information and Management Systems Society, leaders were optimistic they'd achieve sustainability, but only “a handful” indicated their organizations “have already been generating revenue streams to sustain operations going forward.”

Aside from the anomalous 2009 appropriations bubble, the ONC's budget over the rest of its history has been repeatedly flattened by Congress. In fact, for the agency's first year, fiscal 2005, its budget was zeroed out by legislators.

Since then, ONC budgets have been remarkably flat, averaging slightly less than $61 million a year, according to the ONC's latest report to Congress.

For fiscal 2015, HHS' budget request to Congress is $74.7 million, well below the average request over the years at $81.6 million, with the average cut to an ONC budget request running at 22.3%. For the current year, ONC asked for $77.9 million and—after a 22% whacking by Congress—was given $60.4 million.

The great bulk of the spending on health IT under the ARRA was actually controlled by the CMS, not the ONC, coming from the electronic health-record incentive payment programs under Medicare, Medicaid and Medicare Advantage...


As Committee Pursues Policies to Foster Health Care Innovation, Leaders Question Agency Plan to Increase Health IT Regulation and Fees
June 3, 2014

Members Question Authority and Rationale for Expanded Regulatory Approach, Underscore Commitment to Safe and Innovative New Approaches for Technology in Health Care

WASHINGTON, DC – House Energy and Commerce Committee leaders today sent a letter to Karen DeSalvo, National Coordinator for Health Information Technology in the Department of Health and Human Services Office of the National Coordinator (ONC), questioning the ONC’s authority to expand its regulatory role in the Health IT space. The leaders are concerned that a report released in April 2014 “suggests that the Office of the National Coordinator for Health Information Technology would, among other things, create a Health IT Safety Center for the purposes of regulating software and other Health IT products. In addition, the ONC 2014 budget suggests it will impose a new user fee on Health IT vendors and developers to support ONC’s certification and standardization activities.”

The leaders write, “it is not clear to us under what statutory authority ONC is now pursuing these enhanced regulatory activities, including the levying of new user fees, on Health IT.”

The Office of the National Coordinator was legislatively established in 2009 as part of the Health Information Technology for Economic and Clinical Health Act (HITECH Act) of 2009. Late last week, ONC announced a leadership structure that, among other things, creates an Office of Standards and Technology. As the ONC is poised to reorganize itself, committee leaders want to better understand how the agency believes it can carry out a host of new functions amid concerns that it might be overstepping its statutory authority. Fostering and promoting better integration of technology, innovation, and health care has been a central tenet of the committee’s 21st Century Cures initiative. Members are concerned that another layer of bureaucracy could hamper such efforts.

The letter was signed by full committee Chairman Fred Upton (R-MI), Health Subcommittee Chairman Joe Pitts (R-PA), full committee Vice Chairman Marsha Blackburn (R-TN), and Communications and Technology Subcommittee Chairman Greg Walden (R-OR).
Read the complete letter online here. Also, from Government Health IT:
DeSalvo on Tuesday received a letter from the Energy and Commerce committee demanding answers. Specifically, they want DeSalvo to address these four questions:
  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?
At the heart of those questions are ONC’s intentions to create a Health IT Safety Center to regulate software and other HIT products, the committee explained, and the fact that ONC’s “2014 budget suggests it will impose a new user fee on health IT vendors and developers to support ONC’s certification and standardization activities,” as well as whether or not ONC actually has the authority to carry out its intentions.
Recall my Q&A with Dr. DeSalvo at HIMSS14 back in February. Have to wonder whether ONC is now effectively finished. Probably too early to say. Upton's hearing is not likely to do much more than his prior ones have. I think it's a safe bet, though, that if the GOP retakes the Senate this fall, Congress will do nothing beyond Impeachment hearings and related stuff like "Benghazi" -- and now the new POW trade "Berghazi" dustup.

We shall see.


I have been mostly offline for blogging the past few days. Last Saturday my aged 2004 desktop iMac finally gave up the ghost. I'd bought a Canon Pixma Pro 100 oversize-print (13 x 19) color printer, and after I'd installed it, I think it was just too much for the old machine to handle. It went squirrely, and then finally refused to boot up clean (it had been randomly locking up and crashing multiple times a day of late).

So, I went to the Apple Store in Walnut Creek and forked over the AMEX card for the baddest new 27" iMac they make: 32 gigs of RAM, a 3 TB hard drive, 3.5 GHz quad CPU chipset, 8 gigs accelerated graphics RAM. Brought it home, took it out of the box, set it up on the desk in my office, plugged it in, hooked it up to my 2 TB Time Capsule, turned it on, and selected "migrate."

Took about 6 hours (I had about 600 megs of apps and data on the old iMac, including my more than 40,000 photos). Pretty flawless, though I did have to engage Adobe tech support to get my subscription Creative Suite 6 working properly, and had to re-download the ~120 books in my Kindle reader.

It went about as smoothly as I could have asked for.

A 2004 iMac. LOL. A friend wagged me on Facebook: "that's like putting 500,000 miles on a Honda." 

The effective useful life on the PC side is about 3 years.

I am now more of a "Mac Snob" than ever. When I was with the REC, it always cheesed me off that there were only one or two native Mac EHR platforms.

More to come...

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