HHS Clarification: DeSalvo Will Retain Leadership of ONC
Five days after announcing that National Coordinator Karen DeSalvo’s appointment as Acting Assistant Secretary of Health, the ONC clarified that DeSalvo would still be the leader of the ONC; she would also continue to chair the HIT Policy Committee, lead the development and finalization of the Interoperability Roadmap, and remain involved in MU policymaking.
HHS said that when DeSalvo’s new appointment was originally announced, DeSalvo’s bio had mistakenly indicated that she had “previously” held the role of National Coordinator.
HIT NEWSER’S TAKE: Did HHS simply do a poor job communicating or did someone recognize a little too late that DeSalvo’s removal might heighten concerns about the ongoing turnover among ONC leadership?
No More CCHIT
The Certification Commission for Health Information Technology (CCHIT) announced it was shutting down its operations November 14. CCHIT was created in 2004 to provide certification services for HIT products and to educate providers and IT developers; in January CCHIT announced it would no longer provide testing and certification services for the MU program. In a press release CCHIT Executive Director Alisa Ray said that “the slowing of the pace of ONC 2014 Edition certification and the unreliable timing of future federal health IT program requirements made program and business planning for new services uncertain.”
HIT NEWSER’S TAKE: Coupled with the recent turmoil at the ONC (leadership changes, underwhelming Stage 2 MU attestations numbers), one can’t help but wonder what it all means for long-term viability of the MU program and whether the industry remains committed to its objectives.
Healthcare IT is bustling with activity these days. There are big changes in the air and, only time will tell, but we may be witnessing a defining moment in HIT. Naturally, everybody involved has an opinion and some folks, yours truly included, have more than one.
Below are some of the more popular opinions amongst physicians and a considerable portion of industry analysts.
The current EHRs on the market are outdated legacy systems
This is the battle cry of every new entrant to the market. First the ASP, or web based, vendors referred to the existing client/server vendors as legacy systems. This is about to change once the iPhone EHR vendors start calling the web EHRs legacy systems. One common thing that new vendors tend to gloss over is the fact that the existing vendors did not stop writing software in 1995. Most incumbents are releasing updates and major new versions on a regular basis, and by now most Visual Basic code has been replaced by .NET and the latest Java technologies. True, here and there, you can still find MUMPS platforms, but even the VA’s VistA is in the process of getting a major upgrade towards generic web based capabilities, not to mention the futuristic bombshell veteran EHR vendor e-MDs is about to toss into the mix.Continue reading…
Can you buy an ONC Certified EHR, or EHR module, and discover to your chagrin that no matter how hard you try, Meaningful Use is not within reach?
While the spotlights were shining brightly on CMS and ONC as the final definitions of Meaningful Use (MU) and EHR certification criteria were being released, NIST quietly posted its (almost) final definition of EHR testing procedures for certification. The procedures still need ONC’s stamp of final approval, but it seems that this is just a formality. In the past I expressed misgivings regarding the “lightness” of the draft version of the NIST testing procedures, so naturally I was curious to see the final documents. Although some problematic procedures were simply removed from the final version, others still remain.
Thus the answer to the opening question above is a resounding Yes.
In an attempt to part ways with the heavy handed CCHIT certification model, NIST adopted a simplistic, narrowly defined set of testing procedures. Vendors, particularly small ones who never underwent CCHIT certification, will likely be happy with the latitude afforded by NIST. However, the lack of specificity may very well place unsuspecting physician buyers in a bad situation, and here is how.
§170.302(h) – Incorporate laboratory test results: The final ONC certification rule does not require a particular standard to be used by the EHR for receiving structured lab results. All comments submitted to ONC requesting standard specification have been rejected in the interest of flexibility. Adhering to the ONC ruling, NIST allows the EHR vendor to select any format they desire for certification purposes. A comma or pipe delimited text file will do.National reference labs, like Quest and LabCorp, as well as smaller regional labs and hospital labs, are all standardized on some minor version of the HL7 2.X standard for transmission of lab results. An EHR, or EHR module, passing ONC certification with anything but the industry accepted HL7 standards will be unable to connect to any laboratories. The “older” EHRs, which have submitted to CCHIT certification in the past, all have working HL7 lab interfaces. The concern is with brand new products, certifying for the first time.
Assuming the EHR, or EHR module, has HL7 capabilities for lab results, there is still a major hurdle to overcome. National reference labs have long implementation queues and stringent testing and certification processes of their own. It may take 6 months or so, for a new EHR vendor to establish the first live interface with a reference lab. Any subsequent interfaces must also undergo testing and could also take months to create, depending on both vendor and lab availability of resources.
For a physician contemplating the purchase of a particular EHR this translates into a need to obtain documented proof from both the EHR vendor and the Lab(s) that operational interfaces exist for the Laboratories used by the practice. It also requires that you factor in the additional time it will take to create your particular interface(s).
§170.304(b) – Electronically exchange prescription information: NIST has decided that for certification purposes, only the ability to send out a new prescription will be tested. The entire test procedure consists of generating NEWRX messages according to the SCRIPT standard and sending them to a vendor identified external system. Successful testing is decided based on the correctness of the generated message. An EHR, or EHR module, conforming to this particular test is not guaranteed to be able to satisfy the MU criterion. Not by a long shot.EHRs need to connect to the Surescripts network in order to send prescriptions electronically to pharmacies. Surescripts requires the EHR vendor to go through an arduous testing process prior to being allowed to use the network. The ability to send out new scripts is only a small part of Surescripts testing. The vendor must have the ability to also receive error response messages from Surescripts and the pharmacy, receive and respond to refill requests from the pharmacy and send renewal messages to pharmacies. Surescripts must also be satisfied that the EHR’s user interface conforms to Surescripts standards. Surescripts certification is a lengthy process and it is not unusual for it to extend well beyond eight months.
In a nutshell, a physician aiming to become a meaningful user and collect Government incentives must ensure that the ONC certified EHR about to be purchased is also Surescripts certified. ONC certification for this core MU requirement is meaningless.
§170.302(d) – Maintain active medication list: The minimalistic NIST test procedure for this criterion will not affect Meaningful Use or stimulus incentives. It may, however, adversely affect patient care. This test procedure actually presumes that each time a prescription is modified, such as changing dosage or frequency, any and all previous history of said prescription is erased. For example, if a few weeks ago you prescribed Celexa 20mg and today you and the patient decide to increase the dose to 40mg, the medical record will show that the patient was started on Celexa today, and the dose is 40mg. There will be no visible trace of the 20mg regimen in the EHR.Again, “older” EHRs, having gone through CCHIT certification at some point, will probably retain correct medication histories. New EHRs and EHR modules, written to the NIST testing specifications, may not. Unlike lab interfaces and electronic prescriptions, there is no obvious third party verification to look for when shopping for an EHR. This type of problem will not be discovered by a prospective buyer until the EHR has been purchased, installed and used for some time. At that point, with histories lost, the only recourse would be to request the vendor to provide an enhancement to certified functionality.
These are just the most obvious problems. Generally speaking, the test procedures are so narrowly defined that recording such things as who modifies allergies, vital signs, medications or problem lists, or when these were modified, or why, are not a requirement for passing the tests. Presumably, these are all recorded in the audit logs, but there is no specific inspection of the logs and anyway clinicians are not going to consult audit logs on a routine basis. Many other test procedures are of similarly superficial nature, suggesting that NIST is not attempting to certify a product as much as it is trying to certify a technology framework which could be ultimately used to build a meaningful product.
Bottom Line: Physicians need to understand, and ONC needs to clarify, that although required by CMS, ONC EHR certification does not guarantee availability of all EHR features and functionalities required to achieve Meaningful Use.
Margalit Gur-Arie blogs frequently at her website, On Healthcare Technology. She was COO at GenesysMD (Purkinje), an HIT company focusing on web based EHR/PMS and billing services for physicians. Prior to GenesysMD, Margalit was Director of Product Management at Essence/Purkinje and HIT Consultant for SSM Healthcare, a large non-profit hospital organization.
For nearly four years, the Certification Commission for Health Information Technology (CCHIT) has been the lone entity recognized by the federal government to certify electronic health record systems. Since being named a recognized certifying body by Health and Human Services (HHS) in 2006, CCHIT has awarded certifications to nearly 200 EHR software products based on CCHIT’s standards of functionality, interoperability, usability and security.
However, CCHIT’s role in the EHR market is changing. The Office of the National Coordinator of Health IT (ONC) and the Center for Medicare & Medicaid Services (CMS) announced in early March 2010 that they would name more than one organization to certify EHR software, countering previous claims that CCHIT would become the sole certifying body. The certification requirements are in accordance with 2009’s Health Information Technology for Economic and Clinical Health (HITECH) Act.
As this news swirled around, one doctor called Software Advice and asked: “Is CCHIT dead?”
Dead? No. But it appears that the organization’s influence is waning.
A few days ago, I wrote about Innovation, a term being overused in the EHR industry to the point where it lost all meaning. Here is another such term: Usability
Just like Innovation, Usability is the weapon du jour against the large and/or established EHR vendors. After all, it is common knowledge that these “legacy” products all look like old Windows applications and lack usability to the point of endangering patients’ lives. On the other hand, the new and innovative EHRs, anticipated to make their debut any day now, will have so much usability that users will intuitively know how to use them before even laying their eyes on the actual product. With this new generation of EHR technology, users will be up and running their medical practice in 5 minutes and everybody in the office will be able to complete their tasks in a fraction of the time it took with the clunky, legacy EMRs built in the 90s. And all this because the new EHRs have Usability, not functionality, a.k.a. bloat, not analytical business intelligence and definitely not massive integration, a.k.a. monolithic. No, this is the minimalist age of EHR haiku. Less is better, as long as it has Usability.
Usability, according to the Usability Professionals Association, is “the extent to which a product can be used by specified users to achieve specified goals with effectiveness, efficiency and satisfaction in a specified context of use [ISO 9241-11]”. Based on this definition, it stands to reason that any EHR prospective buyer should want a product with lots of Usability. Everybody wants to be effective, efficient and satisfied. So how does one go about finding such EHR?
Well, as always, CCHIT picked up the glove, and as always, CCHIT will be criticized for doing so. The 2011 Ambulatory EHR Certification includes Usability Ratings from 1 to 5 stars. The ratings are based on a Usability Testing Guide. Jurors are instructed to assess Usability of the product during and after the certification testing based on three criteria: Effectiveness, Efficiency and the subjective Satisfaction, as required by the ISO standard. The tools for this assessment consist of 3 types of questionnaires:
After Scenario Questionnaire (ASQ) –jurors rate perceived efficiency (time and effort), learnability, and confidence after viewing scenarios
4 questions after each scenario –16 overall
Perceived Usability Questionnaire (PERUSE)–jurors rate screen-level design attributes based on reasonably observable characteristics
20 questions divided among each of the scenarios;
System Usability Survey (SUS) –jurors rate the assessment of usability, and satisfaction with the application
10 questions after all four scenarios have been demonstrated
The questions range from general subjective assessments in the ASQ, to very specific inquiries in PERUSE, like whether table headers are clearly indicative of the table columns content. Following the certification testing, results from all jurors are combined and weighted with more weight to specific answers and less to subjective overall impressions. The final result is the star rating, ranging from 1 to 5 Usability stars.
As of this writing, 19 Ambulatory EHRs have obtained CCHIT 2011 certification and all of them have been rated for Usability presumably according to the model described above. Of those, 12 achieved 5 stars, 6 have 4 stars and 1 has 3 stars. Amongst the 5 stars winners, one can find such “legacy” products as Epic, Allscripts and NextGen. The 4 and 3 stars awardees are rather obscure. So what can we learn from these results?
The futuristic EHR movement will probably dismiss these rankings as the usual CCHIT bias towards large vendors. Having gone through a full CCHIT certification process a couple of years ago, I can attest that the only large vendor bias I observed was in the functionality criteria, which seemed tailored to large products. Big problem. However, the testing and the jurors seemed very fair and competent. Looking at the CCHIT Usability Testing Guide, I cannot detect any bias towards any type of software. I would encourage folks to read the guide and form their own unbiased opinions. Are we then to assume that the 5 Stars EHRs have high Usability and therefore will provide satisfaction?
I don’t have a clear answer to this question. Obviously these EHRs have all their buttons and labels and text conforming to the Usability industry standards, and obviously a handful of jurors watching a vendor representative go through a bunch of preset tasks on a Webex screen felt comfortable that they understand and could use the system themselves without too much trouble. Many physicians feel the same way during vendor sales demos. However, efficiency and effectiveness can only be measured by repetitive use of the software in real life settings, for long periods of time and by a variety of users. Measuring satisfaction, the third pillar of Usability, is a different story altogether. There isn’t much satisfaction about anything in the physician community nowadays and when one is overwhelmed with patients, contemplating pay cuts every 30 days or so and bracing for unwelcome intrusion of regulators into one’s business, it’s hard to find joy in a piece of software, no matter how well aligned the checkboxes are.
The bottom line for doctors looking for EHRs remains unchanged: caveat emptor. The footnote is that the bigger EHRs are as usable as the Usability standards dictate, just like they are as meaningful as the Meaningful Use standards dictate and when all is said and done it is still up to the individual physician user to pick the best EHR for his/her own Satisfaction.
Margalit Gur-Arie is COO at GenesysMD (Purkinje), an HIT company focusing on web based EHR/PMS and billing services for physicians. Prior to GenesysMD, Margalit was Director of Product Management at Essence/Purkinje and HIT Consultant for SSM Healthcare, a large non-profit hospital organization.
2009 began with a bang for legacy Electronic Health Record (EHR) vendors, promising strong sales and windfall profits on the heels of stimulus package incentive bonuses initially worth more than $19 billion to doctors and hospitals. But things changed dramatically along the way.
Here ten surprises and notable events that have impacted the EHR market:
Payment for Meaningful Use of EHR technology, not for the software and hardware itself.
The idea that using EHR technologies ought to produce improvements in quality of care, better communication with patients, enhanced safety, and better public health reporting — and that these outcomes ought to be monitored and providers held accountable for their achievement — was itself a surprising innovation in 2009. It has to be counted among the best 10 health care ideas to come out of government in the past generation.Continue reading…
Many of us have enjoyed a few good minutes of fun having our fortunes told by soothsayers who claim they can predict our future based on patterns of tea leaves in a cup or the playing cards we’ve pulled from a deck.
We pay a few dollars for the entertainment and if the fortune teller is skilled, we are temporarily impressed by his “insight.” But once we leave the carnival, we come back to our senses. Fortune-tellers can’t predict the future.
With its latest announcement, the Certification Commission for Healthcare Information Technology (CCHIT) appears to have entered the fortune telling business.
And if information provided on blogs published by its founders is to be believed, some EHR vendors plan to have their fortunes told by the former EHR certification monopolist.
In June, ONC’s HIT Policy Committee released a Meaningful Use Matrix and proposed that it should serve as the basis for EHR certification as mandated by ARRA, the economic stimulus program signed into law last winter.
The Matrix consisted of five “Health Outcomes Policy Priorities” and associated Care Goals, Objectives and Measures. The Committee anticipated that the latter would be transformed into EHR certification criteria.
After a 2-month public comment period, the Committee tweaked the Matrix, essentially pushing back time-frames for implementing computerized order entry, and accelerating time-frames for implementing personal health records.
By mid-August, the Committee had approved a final version of the Matrix.
This document includes the very latest information on ARRA-mandated EHR certification criteria. It is in the public domain, there for all to see. ONC is expected to finalize these criteria next spring.
The criteria are not consistent with those used by CCHIT to certify EHRs. They are outcomes-oriented (CCHIT’s are feature, structure and process-oriented), and they do not require that any particular technology (such as the client-server applications used by the legacy vendors who sit on the board of CCHIT) be used to achieve the results.
Subsequently, HHS announced that it planned to assume responsibility for deciding which EHR systems qualified for bonus payouts under Medicare, and shortly thereafter, ONC’s HIT Policy Committee said that it planned to recommend that several entities should certify EHR systems.
The upshot of these moves by the Federal government are that (1)CCHIT no longer decides what criteria will be used to certify EHRs, and (2)its days as the exclusive provider of EHR certification services are numbered.
What has CCHIT decided to do in response to these setbacks?
It’s decided to become a fortune-teller!
New Role for CCHIT
Last week, CCHIT announced it will begin offering “streamlined,” or “modular” certification options, in which EHR vendors can apply to the agency for approval of distinct EHR modules like e-prescribing or electronic patient registries.
But as mentioned above, ONC won’t sign-off on its “meaningful use” criteria until the spring of 2010. In effect, CCHIT is asking EHR vendors to gamble that CCHIT can, like a fortune teller at a carnival, predict what those final recommendations will be.
“Choose the risk you want to take,” CCHIT Chairman Mark Leavitt recently challenged vendors. “Go ahead now (with a CCHIT review) and have an extra year to implement, with a small risk that there will be some gap in which EHR systems would have to be updated to receive final certification…” or risk the consequences of sitting on your hands, he presumably would add.
Never mind that the latest information is in the public domain, and that any vendor can compare it against their current capabilities and development plans! Disregard the fact that CCHIT has no track-record in promulgating outcomes-oriented certification criteria or in certifying against them!
What is CCHIT charging for its fortune-telling expertise? According to Government HealthIT, a HIMSS sponsored publication, prices for modular certification begin at $6,000 for up to 2 modules. They rise to $24,000 for up to 20 modules and to $33,000 for more than 20.
As always, fees for CCHIT’s comprehensive certification are $37,000 for ambulatory systems and $49,000 for hospital systems. Annual renewal costs are $9,000 for each.
That’s chump-change for the legacy vendors whose top executives sit on the board of CCHIT, but it guarantees nothing.
Conclusions and Recommendations
EHR vendors should perform their own analyses against the published HIT Policy Committee criteria and follow the HHS Web site for announcements regarding meaningful use criteria and the process by which EHRs will be certified.
If a vendor insists on having its fortunes told, it should consult with a reader of tea leaves next time the carnival is in town.
Glenn Laffel is a physician with a PhD in Health Policy from MIT and serves as Practice Fusion’s Senior VP, Clinical Affairs. He is a frequent writer for EHR Bloggers, where this post first appeared.
Below is a slightly expanded version of a letter I recently sent to Dr. Blumenthal, the new National Coordinator for Health Information Technology, and the members of the new national HIT Policy Committee.
Dear Dr. Blumenthal:
I am writing to you on the need for user-friendly electronic health record (EHR) software programs. As a practicing physician with first-hand experience with hard-to-use CCHIT-certified EHR software, I would like to share with you a solution to this vital issue.
The CCHIT model for EHR software certification is fatally flawed because it mandates hundreds of required features and functions, which take precedence over good software design. This flawed CCHIT model takes valuable physician time and effort away from patient care and leads to increased potential for errors, omissions, and mistakes.
As a clinician, I have had first-hand experience with a top-tier CCHIT-certified EHR. Despite being computer literate and being highly motivated, after a year and a half of concerted effort, I still cannot effectively use this CCHIT-certified program. The poorly designed software constantly intrudes on my clinical thought process and interferes with my ability to focus on the needs of my patients.
provide little support for the cognitive tasks of the clinicians or the workflow of the people who must actually use the system. Moreover, these applications do not take advantage of human-computer interaction [HCI] principles, leading to poor designs that can increase the chance of error, add to rather than reduce work, and compound the frustrations of executing required tasks.
Our health care system needs user-friendly EHR software, firmly grounded on what we have learned about how the human brain takes in, organizes, and processes information.
As an example of software based on usability principles, I would like to share with you a new design, the EHR TimeBar, which is one example of user-friendly EHR software design that can dramatically improve patient care. Please see attached figure and description at the end of this letter.
I have no financial interest in this software design. My goal is to promote the emergence of user-friendly EHR technology that will improve the day-to-day lives of my colleagues and help us take better care of our patients.
We absolutely need standards for data, data transmission, interoperability, and privacy. There is no need, however, to specify the internal workings of EHR software. To do so will stifle innovative software designs that could improve our health care system. If CCHIT is allowed to mandate the meaning of the term “certified-EHR,” the $17 billion allocated for EHR adoption and use will largely be wasted.
The solution is to keep EHR certification rules simple to encourage an open market model. An open market will foster a competitive environment, leading to the emergence of user-friendly EHR software that is simple, helpful, efficient, and inexpensive – software that will improve both patient care and the day-to-day lives of our clinicians.
I appreciate your work and the work of the HIT Policy Committee members in crafting our new national health care IT plan.
In a recent blog post on THCB, Mark Leavitt wrote this about me: “[Dr. Kibbe’s] repeated use of falsehoods and innuendo to attack CCHIT have found an audience in the national media, reaching a level that can no longer be ignored. By implication, he demeans the integrity of everyone who has contributed to that work – and I must rise to their defense.”
The truth is that I respect both Dr. Leavitt and, equally important, the many fine people who have contributed to CCHIT work. I regret that he has made me the target of his anger about investigative reporting in the Washington Post, which I certainly did not initiate.
To clarify what I actually said, after a brief interview, quoted in the second of two articles in the Washington Post by Robert O’Harrow, Jr, a Pulitzer Prize finalist :
“One has to question whether or not a vendor-founded, -funded and -driven organization should have the exclusive right to determine what software will be bought by federal taxpayer dollars,” Kibbe said. “It’s important that the people who determine how this money is spent are disinterested and unbiased . . . Even the appearance of a conflict of interest could poison the whole process.”
Raising questions and concerns like these does not reach the level of “falsehoods and innuendo.” In my opinion, it is entirely appropriate to ask tough questions about whose interests are being served when $36 Billion of tax payers’ money is involved, and the future of health IT in the U.S. will be the result of certification.”
I am not the only one with these concerns. Many other health care and health IT professionals have raised legitimate questions about CCHIT and its practices, its relationship with HIMSS, and yet to date these have not been resolved. A response that attacks me personally and labels me a liar is far from adequate, and so the questions will remain.
The stakes are too high to simply look the other way.
David C. Kibbe MD MBA is a Family Physician and Senior Advisor to the American Academy of Family Physicians who consults on healthcare professional and consumer technologies.