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Tag: HHS

The Primary Care Workforce: Help is on the Way

The best electronic health record on the planet isn’t going to help anybody unless a physician uses it. The HITECH incentive scheme should enhance the woefully poor EHR uptake rates among US providers, as should innovative vendor business models that remove cost-barriers which have prevented many from getting in the game.

But there’s an even more fundamental issue, which is a looming manpower shortage among the ranks of US primary care physicians, a topic we’ve covered numerous times, most recently here. There simply aren’t enough physicians to use those EHRs!

Communities across the nation have long suffered from a lack of PCPs. The problem is expected to worsen as baby boomers age and the number of medical students who enter primary care continues to drop. If nothing is done to change current trends, the Association of American Medical Colleges estimates our country will be short 21,000 and PCPs in 2015 and a whopping 47,000 in 2025.

Now, finally, something is being done. And while it may not be enough, it certainly points us in the right direction. More importantly, it sets a precedent for future interventions by the federal government.

This Wednesday, Department of Health and Human Services Secretary Kathleen Sebelius announced $250 million worth of new investments designed to support the training and development of more than 16,000 new primary care providers over the next five years. The investments were mandated by the Affordable Care Act, that controversial health care bill signed into law by President Obama in March.

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Why Rush Vendor Certification of EHR Technologies?

A surprise move by ONC/HHS indicates the wheels may be falling off health IT reform at about the same rate they’ve fallen off Democrats’ broader health reforms.

David Blumenthal and his staff have unveiled two separate plans to test and certify EHR technology products and services. We don’t think this is a good idea. We’ve supported the purpose and spirit of the ARRA/HITECH incentive programs, and believe ONC’s/HHS’ re-definition of EHR technology puts it on a trajectory to improve the quality and efficiency of health care in the U.S. But this recently-announced two-stage EHR technology certification plan bears all the marks of a hastily drawn up blueprint that, if rushed into production, could easily collapse of its own bureaucratic weight.

The new Proposed Rule puts vendors through the wringer, twice. As defined by ONC, vendors with “complete EHRs” and those with “EHR modules” will have to find an “ONC-approved testing and certification body” (ONC-ATCB) that will take them through a “temporary certification program” from now until end of 2011. Then in 2012, under a “permanent certification program,” they’ll have to switch over to a National Voluntary Laboratory Accreditation Program (NVLAP)-accredited testing body for testing, after which they must seek an “ONC-approved certification body” (ONC-ACB, not to be confused with ONC-ATCB) that can provide certification. The ONC-ATCB will be accredited by ONC, but the ONC-ACBs will be accredited by an “ONC-approved accreditor” (ONC-AA).Continue reading…

Finally, A Reasonable Plan for Certification of EHR Technologies

A caution to readers: This post is about methods for certifying Electronic Health Record (EHR) technologies used by physicians, medical practices, and hospitals who hope to qualify for federal incentive payments under the so-called HITECH portion of the American Recovery and Reinvestment Act (ARRA). It may not be as critical as the larger health care reform effort or as entertaining as Sarah Palin, but it WILL matter to hundreds of thousands of physicians, influencing how difficult or easily those in small and medium size practices acquire health IT. And indirectly for the foreseeable future, it could affect millions of American patients, their ability to securely access their medical records, and the safety, quality, and the cost of  medical care.

Three weeks ago, on July 14-15, 2009, the ONC’s Health IT Policy Committee held hearings in DC to review and consider changes to CCHIT’s current certification process. The Policy Committee is one of two panels formed to advise the new National Coordinator for Health IT, David Blumenthal. In a session that was a model of open-mindedness and balance, the Committee heard from all perspectives: vendors, standards organizations, physician groups, and many others.

And then, on July 16, they released their final recommendations on what is now referred to as “HHS Certification.” The effects of their recommendations – these are available online and should be read in their entirety to grasp their extent – are potentially monumental, and could very positively change health IT for the foreseeable future.

At the heart of these hearings was the issue of who will define the certification criteria and who will evaluate vendors’ products. Among many others, we have voiced concerns that the Certification Commission for Health Information Technology (CCHIT), the body currently contracted by HHS to perform EHR certification, has been partial to traditional health IT vendors in defining the certification criteria, and in the ways certification is carried out, and thereby able to inhibit innovation in this industry sector. Despite its leaders’ claims that the certification process has been developed using an open framework, CCHT’s obvious ties to the old guard IT vendors have created an overwhelming appearance of conflict of interest. That appearance has not been refuted by CCHIT’s resistance to and delays in implementing interoperability standards, or by its focus on features and functions over safety, security, and standards compliance.

In the hearings that led to the recommendations, longtime IT watchers were treated to some extraordinary commentary, much of which dramatically undermined CCHIT’s position.

“HHS Certification means that a system is able to achieve government requirements for security, privacy, and interoperability, and that the system would enable the Meaningful Use results that the government expects…HHS Certification is not intended to be viewed as a ‘seal of approval’ or an indication of the benefits of one system over another.”

In other words, as the definition of Meaningful Use is now tied to specific quality and safety improvements and cost savings that result from health IT — among them e-Prescribing, quality and cost reporting, data exchange for care coordination, and patient access to summary health data — HHS Certification will closely follow. Rather than pertain to an EHR’s long list of features and functions, some of which have nothing to do with Meaningful Use, certification will be focused on each IT system’s ability to enable practices and hospitals to collect, store, and exchange health data securely.

Who Determines the Certification Criteria

The Office of the National Coordinator – not CCHIT – would determine certification criteria, which “should be limited to the minimum set of criteria that are necessary to: (a) meet the functional requirements of the statute, and (b) achieve the Meaningful Use Objectives.” As regulator, funder for this project, and a major purchaser of health services, the government, not users or vendors, will now determine HHS’ Certification criteria.

A New Emphasis on Interoperability

“Criteria on functions/features should be high level; however, criteria on interoperability should be more explicit.” That is, functions/features criteria will be broadly defined, but there will be a greater focus in the future on the specifics associated with bringing about straightforward data exchange.

Multiple Certifying Organizations

ONC would develop an accreditation process and select an organization to accredit certifying organizations, then allow multiple organizations to perform certification testing. In other words, the Committee recommended that CCHIT’s monopoly end.

Third Party Validation

The “Validation” process would be redefined to prove that an EHR technology properly implemented and used by physician or hospital can perform the requirements of Meaningful Use. Self-attestation, along with reporting and audits performed by a Third Party, could be used to monitor the validation program.

Broader Interpretation of HHS Certification

HHS Certification would be broadly interpreted to include open source, modular, and non-vendor EHR and PHR technologies and their components.

These bold, forward-thinking proposals from the HIT Policy Committee have not been accepted yet. But in our opinion they should be. These measures would encourage new technologies to enter the market for physician medical practices seeking EHR technology, and wrest control away from the legacy health IT vendors that have maintained barriers and delayed adoption, so you can be sure that the old guard players are doing everything possible to have them rejected.

But these are hugely progressive steps in the right direction, toward allowing HIT to enable improvements in care and cost efficiencies that would be in the best interests of users and the public at large. If implemented, the changes recommended by the HIT Policy Committee would create greater choice, more standardization, lower price, less interruption of the practices — as well as a check from CMS or Medicaid each year to help smooth the implementation, starting in 2011.

David C. Kibbe MD MBA is a Family Physician and Senior Advisor to the American Academy of Family Physicians who consults on health care professional and consumer technologies. Brian Klepper PhD is a health care market analyst. Their collected collaborative columns may be found here.

Disruption breaking out over at Scott Shreeve’s place

Clayton Christensen's publisher is pressing me to read The Innovators Prescription and then interview him. Sadly I haven’t had the time to pay the book the attention it deserves. Messrs Kuraitis & Kibbe already did a review on THCB and probably said what I’d say, which was that like several other Harvard Business School profs, they got the problem right but the solution wrong. I’m on record from a couple of years back saying that Christensen’s guns are aimed in the wrong direction.

But to be fair my criticisms are pre-publication. Scott Shreeve has a great interview with Christensen’s co-author Jason Hwang (the late Jerome Grossman is also a co-author). and in this interview several of the incentive issues which concern those of us who understand how innovation gets stopped in health care, are addressed. Well worth reading.

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Daschle out at HHS – Sharfstein in at FDA?

Oie_090203_daschle_634The early stages of the Obama administration are beginning to
resemble the Clinton years, which I 
observed from afar (I was a foreign
correspondent in Tokyo at the time). Take Zoe Baird and substitute Tom
Daschle, who dropped out of the running for Secretary of Health and
Human Services today because of tax and conflict-of-interest problems.
Take gays in the military and substitute putting in charge of the bank
bailout a man (Tim Geithner) who knows all the bankers from his years
at the New York Fed, seems overly solicitous to their needs, and has
his own tax problems.

Once again, a new Democratic president appears to have a semi-automatic weapon semi-permanently aimed at his foot.

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The Case for Ron Wyden

Wyden_smile
Let me be the first to suggest that the President name Senator Ron Wyden (D-OR) to be the next 
Secretary of HHS. The withdrawal by Tom Daschle has underscored just how important it will be for the President to name someone who can bring a number of key strengths to the job.

All day reporters have been asking me whom the best person was for the
President to now turn to and get his health care agenda back on track.

Seems to me Ron Wyden fits the bill.

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