Not So Meaningful EHR Certification

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.

Why EHR?

The regulators have completed their work. CMS has defined how you should use technology in your practice or hospital (Meaningful Use) and technical requirements for EHRs have been finalized. CMS and ONC have removed all ambiguity regarding Government financial assistance to those purchasing EHRs, and ONC certified EHRs will start appearing shortly. A national network of federally funded EHR adoption assistance centers for underserved Primary Care docs is slowly beginning to take shape. Everything you need to know to start your “EHR Journey” is in place. The only open questions left, for physicians with inquiring minds, are why should I buy an EHR, and why should I buy it now. Below, we will try to explore the answers provided by Government regulators, payers, patients and even early adopting physicians who completed the EHR journey or are in the last mile of the Meaningful Use race.

The Government

I cannot remember a similar situation in the past, where an entire election and much political capital has been invested in the software buying habits of a particular segment of the economy. Of course, the Federal government has been engaged in oversight and best practice dissemination in multiple cases, such as farming, public roads and education to name a few. However, you don’t see any Federal mandates for all schools, public and private, to adopt software, become paperless and collect and exchange terabytes of data. One could argue that such effort will bring enormous benefits to our, not so great, education system, probably as much if not more than to our health care system. Education, just like health care, suffers from lack of funds, poor quality and extreme disparities. The only difference between the two is the sheer amount of money involved.  This observation leads us to the inescapable conclusion that the national EHR effort is first and foremost about reducing, or containing, health care costs. In these turbulent economic times, the Federal government is betting the farm on the promise that computerizing medicine will put a significant dent in our runaway health care costs. Improving quality and reducing disparities, the other two stated objectives, are window dressing, or “nice to have”. To be fair, this is not a bad gamble. Computer technology has been shown over and over again to be capable of cutting costs in many other sectors, and the identified cost cutting targets in health care (duplication of tests, care coordination, administrative simplification, error reduction and standardization on Evidence Based Medicine) lend themselves very well to technological assistance.

Back to the physician contemplating an EHR purchase, the Government wants you to buy an EHR so you can provide care for your patients at a lower cost. As simple as that. The EHR must reduce your overhead, thus reducing cost per unit of service, and must reduce the direct treatment costs, presumably by helping you identify waste and less costly options for achieving the same results (or close enough). With these goals in mind, and ignoring the moral/philosophical arguments, EHR shopping just became significantly more challenging. To be sure, there are no EHRs on the market today, that can actually deliver on all these goals, but some may be able to provide a good start, and once interoperability is widely established, we should see more meaningful gains in cost containment.

Note: There have been more than a few grumblings out there on how a national network of EHRs is really aimed at obtaining patients and physician data to be eventually used for financially penalizing doctors. While I have no doubt that various quality and performance measures will eventually be used for payment purposes by both private and Government payers, I just don’t see this sinister, and very expensive, government plot to either spy on docs or nationalize health care unfolding in the midst of a recession, and with both the 2010 and 2012 elections very much on the line.

The Patient

Notwithstanding the vocal minority of e-patients and patients turned consumers, the vast majority of folks seeking medical care are interested in quality of care, convenient delivery and easy access. For the uninsured, the increasing numbers of underinsured and those with complex out of pocket arrangements (i.e. almost everybody but the exceedingly wealthy), costs of services are quickly becoming an important factor as well. Interestingly enough, this particular patient interest is very well aligned with the Government objective. The avant-garde of e-patients also wants access to their medical records and ability to participate in their own care. While not widespread just yet, it is conceivable that in the not too far future more patients will come to appreciate the convenience of communicating with health care providers over the Internet.

In a nutshell, your patients want to you to buy that EHR so you can reduce the price of care and save them time (and money) by allowing them to manage their medical care in a manner similar to how they now manage their finances. Your patients are a bit more selective than the Government though, and they are placing a more stringent constraint on maintaining and even improving quality of care while you cut costs and increase convenience. They are also planning on holding you to your sworn promises, and will expect that you protect their privacy while computerizing your records. Of course, the many underserved and really sick people in rural areas and inner cities couldn’t care less about your EHR. They will be grateful to just see a doctor outside the ED.

The “Industry”

Corporations on the periphery of actual care for patients, most notably payers, pharmaceutical and device companies and data mining companies, are really and truly only interested in your data. Private payers are also mildly interested in your ability to lower both your overhead (so they can cut your payments) and the total cost of care (so they can keep a larger percentage of the premiums). However, since the new regulations are forcing payers to spend a minimum percentage of their premiums on patient care, it is arguably better to have more expensive care and larger premiums. So for private payers this will be an intricate dance around the Medical Loss Ratio (MLR). As usual, private payers’ interests do not necessarily align with either patients or the Government. Payers also want you to computerize your records in order to reduce their own administrative costs (and again, keep a larger percentage of the premiums). There is little need to discuss EHR vendors here, since their motives are blatantly obvious and fairly legitimate in a capitalist economy.

All in all, the “Industry” wants you to buy an interoperable EHR, so they can collect, buy, sell and mine the vast array of personal and clinical information residing in your medical records, and worth many billions of dollars.

Note: Recently, the safety of EHRs, particularly hospital EHRs and their CPOE modules, has been the subject of various studies and much heated debate with no conclusive results. The possibility of FDA oversight has been suggested, and hopefully such oversight will be implemented sooner rather than later. However, here we are discussing private practice EHRs which are much simpler and restricted in scope.

The Early Adopters

These are your fellow docs who bought the EHR years ago and managed to make the endeavor successful. Their common denominator is mostly a personal willingness to invest time in molding the EHR to their needs, or the availability of an equally committed practice resource who was willing (or tasked) to do so. It is interesting to note that their EHRs come in a rainbow array of sizes and prices, ranging from $50 per month to tens of thousands of dollars in upfront investments. It’s not really about the product. There are perhaps three dozen credible EHR offerings out there (not the mythological several hundred), and as long as one is motivated and he/she plans early and plans well, there is a very good chance that the purchase of an EHR will add convenience for the physician and staff, quality and accessibility for patients, and if coupled with a decent billing system, even a bit of financial benefit.

Your early adopter colleagues are suggesting that you buy an EHR because theirs was a positive experience and they are now in a comfortable position to deal with the rapidly changing health care landscape. These doctors, unless working for a vendor, have no ulterior motives in their recommendations.

Note: As you are well aware, there are also physicians who failed in their EHR implementations and are bitterly warning against buying EHRs. I would venture to submit that it is not the idea of EHR that failed these folks, but the planning and implementation of it. Theirs is a very important learning experience on how not to buy an EHR and it needs to be listened to carefully.

Conclusion

The Government, the taxpayers (of which you are one) and your patients are all interested in reducing health care costs. At its core, EHR adoption is all about the economy, both on a national level and a household level, and with the approaching wave of value-based health care reorganization, it is on a medical practice level too. Since computer technology has been able to bring about cost reductions in many instances, it is reasonable to assume that it can do the same for health care, particularly once a critical mass of interconnected systems is reached. Your early adopter peers have shown that it is possible to introduce an EHR in one’s practice with some initial effort and inconvenience, but with no dire consequences and in some instances with marginal productivity gains. Since the overwhelming health care expenditures are accrued per “doctor’s orders” during millions of visits every day, and since an EHR need not be detrimental to your financial health, perhaps you should consider lending a hand to help rein in the Nation’s health care costs. Perhaps it is simply the patriotic thing to do.

New and Improved Meaningful Use

The long anticipated final rule on Meaningful Use was unveiled yesterday with much pomp and circumstance in a rather unusual ceremony which, interestingly, also marked the first public appearance of Dr. Berwick as CMS Administrator. The Final Rule is contained in an 846 page document. Accompanying the CMS ruling is the 228 pages final EHR certification rule issued simultaneously by ONC. Fortunately for all of us scrambling to figure out what has changed, Dr. Blumenthal released a synopsis in NEJM (recommended). Already many articles and disertations have appeared and indubitably many, many more will be written in the next few days and weeks analyzing every change and every nuance of the new, and now binding, Meaningful Use. For those who don’t care much about nuances, preferring a bigger and lower resolution picture, here are the major changes to the old version of Meaningful Use.

The Good

• By far the biggest relaxation was to divide the original 25 measures (23 for hospitals) into two groups – 15 mandatory measures and 10 optional measures of which only 5 need to be fulfilled, per provider choice. This is in effect a 20% reduction of the Meaningful Use burden.
• They added back a requirement for hospitals to record advanced directives. It is listed in the optional group, which means that some hospitals could choose not to implement it, but one must be grateful for having it back on the list.
• Although CPOE is not optional, it has been scaled back to medication orders only.
• The bewildering array of quality measures has been trimmed to 3 simple core measures (weight, BP, smoking) and only 3 more per provider’s choice.
• Another relief for providers is that EHRs will be required to automatically perform all the calculations of nominators and denominators for all measures that involve percentages, and there are many of those. These calculations were initially supposed to be performed manually by the practice or hospital.
• Several measures which required tracking and reporting, such as CDS alerts, now only require attestation that the functionality is turned on.
• If you are a physician with a nice little EHR that will surely be certified, but has no online PHR, there’s no need to despair. PHRs, Patient Portals or the need to provide online medical records is now optional. Even providing electronic clinical summaries for transitions of care is purely optional.
• You don’t have to rush to the office on weekends to give patients copies of their records. Everything is now measured in business days instead of hours from patient request.

The Bad

• In the ONC certification rule, Immunizations have been removed, along with procedures, from the minimum requirements for data elements to be shared with patients and other providers. For Pediatricians and all parents of young children, particularly this time of year, this is not welcome news. Hopefully vendors will go above the minimum here, since it is rather trivial to provide immunization histories to any interested party.
• The two Administrative requirements of submitting claims electronically and verifying eligibility with payers have been removed. On the surface this makes sense when talking about the use of EHRs. However, the vast majority of providers, hospitals and private practices, already meet both criteria since Medicare and Medicaid require electronic submission of claims, not to mention the potential cost savings from automating such process. 

The Inconsequential

• For most measures, the minimum percentage for compliance has been dropped to about 50% or less. This gives the impression of further concessions, however it is rather meaningless. If you are going to manage medications in the EHR, you will do that for all patients, not just a select 30%. Not to mention that if you use electronic prescribing for some allowed prescriptions and not for others, you will end up with a reconciliation nightmare when electronic renewal requests start flowing in from pharmacies for all your paper scripts. Anyway, placing the bar lower is a friendly gesture from CMS
• Many previously required standards for terminology and data exchange have been relaxed in the ONC document, particularly for labs and medications. While completely irrelevant to physician users, this is a huge win for vendors whose efforts to retool their EHRs are now postponed by a couple of years.

All in all, the new Meaningful Use is a bit more flexible than the old version and what was bound to become a typically painful bureaucratic attestation for physicians, is now a rather straightforward process. Other than that, you still have to buy a certified EHR, install it and meaningfully use it by October 1st 2011. If you’re considering hopping on the bandwagon, call your Regional Extension Center and see if you can get some free services to get the ball rolling. Meaningful Use has been officially declared the Law of the HIT Land and there is no turning back now.

Feel the Burn

Last month PricewaterhouseCoopers released its predictions for Medical cost trends in 2011. The target audience for this report is employers, but it is very enlightening for everybody else. Unsurprisingly health care costs for 2011 are projected at a whopping $3 trillion, but the good news is that the growth in medical costs is projected to be only 9%, down half a percentage point. The good news is of course for employers since these are projections for employers’ costs. How about the rest of us? Will the news trickle down to employees? They sure will, but not exactly as you may think.

PwC distills the complexity down to three factors pushing costs down (deflators) and three factors pushing costs up (inflators) as follows (keep in mind that these are employer costs):

Deflators

• Move to benefits designed to offload cost to employees in the form of higher deductibles, co-insurance and higher co-pays.
• Increased utilization of generics
• Reductions in COBRA benefits due to better economy and expiration of government subsidies

Inflators

• Cost shifting to private insurers due to Medicare payment cuts to hospitals
• Consolidation of private practices from a “cottage industry” to large groups with significant bargaining power
• HIT Meaningful Use expenditures passed on to payers

If we look at the “deflators”, other than generics utilization and the commendable faith in the US economy, coupled with complete disregard for the unemployed rabble, it seems that one’s deflator is another’s inflator. Consumers will be spending a lot more on this intricate web of deductibles, co-pays (flat fees) and co-insurance (a percentage of costs). That is good for us. We will finally develop sensitivity to the real costs of health care as we become empowered to manage our own health, or lack thereof. To meet this need, there will be a vast array of iPhone applications to guide us away from what we need and towards what best deflates our employer’s costs. Make no mistake though; employers by definition have the best interests of their employees at heart. Healthy, happy well-adjusted employees are good for the bottom line, just like happy cows make good cheese in California. This is why our employers will help us with these new responsibilities and hire all sorts of wellness management firms to keep us healthy. Firms like Optum Health who has this lovely maintenance center they install at your workplace where you step in and all your wellness parameters get measured and reported. You can be sure now that someone is always watching over you. May not be that guardian angel grandma was talking about, but there’s definitely someone there.

With the exception of the perennial complaint of Medicare cost shifting, the “inflators” deserve our undivided attention, particularly since the net effects will be trickling down uninhibited directly to our cost-offloading, patient-driven “benefits”. Flying in the face of most luminaries’ published opinions, PwC projects that the anticipated demise of Dr. Marcus Welby will fail to deliver the much touted “economies of scale”, and instead will just drive health care costs up. Absolutely shocking! Since this particular report targets business leaders, it is silent on the effects of health care Walmartization on actual quality of care. Let your imagination roam freely here…..

The most surprising “inflator” is the cost of HIT adoption and Meaningful Use of EHRs, which PwC is expecting to be passed on from providers to payers. Not only that HIT is supposed to increase a provider’s efficiency and reduce costs of health care delivery, but I was under the impression that taxpayers already footed that bill to the tune of 20 or 30 billion dollars (who’s counting). Turns out that this was just a down payment and the monthly invoices are in the mail, attached to our brand spanking new premiums.  Yes, I know, it will take several years to see the benefits. The premiums at Kaiser, which started its epic HIT journey in 2003, are not showing any signs of relief. So we wait…..

Here is the beauty of our health insurance system in its true magnificent simplicity:  Both “deflators” and “inflators” are driving prices of health insurance up for working folks. And this, we are told, is very good for us. Well, we all know exercise is good for you, and at least one part of every American is about to get a vigorous workout – the wallet. Can you feel the burn?

Leapfrogging CPOE

Last week, yet another alarming Computerized Physician Order Entry (CPOE) study made headlines. According to Healthcare IT News, The Leapfrog Group, a staunch advocate of CPOE, is now “sounding the alarm on untested CPOE” as their new study “points to jeopardy to patients when using health IT”. Up until now we had inconclusive studies pointing to increased and also decreased mortality in one hospital or another following CPOE implementation, but never an alarm from a non-profit group who made it its business to improve quality in hospitals by encouraging CPOE adoption, and this time the study involved 214 hospitals using a special CPOE evaluation tool over a period of a year and a half.

According to the brief Leapfrog report, 52% of medication errors and 32.8% of potentially fatal errors in adult hospitals did not receive appropriate warnings (42.1% and 33.9% accordingly, for pediatrics). A similar study published in the April edition of Health Affairs (subscription required), using the same Leapfrog CPOE evaluation tool, but only 62 hospitals, provides some more insights into the results. The hospitals in this study are using 7 commercial vendors and one home grown system (not identified), and most interestingly, the CPOE vendor had very little to do with the system’s ability to provide appropriate warnings. For basic adverse events, such as drug-to-drug or drug-to-allergy, an average of 61% of events across all systems generated appropriate warnings. For more complex events, such as drug-to-diagnosis or dosing, appropriate alerts were generated less that 25% of the time. The results varied significantly amongst hospitals, including hospitals using the same product. To understand the implications of these studies we must first understand the Leapfrog CPOE evaluation tool, or “flight simulator” as it is sometimes referred to.

The CPOE “simulator” administers a 6 hours test. It is a web based tool where hospitals can print out a list of 10-12 test patients with pertinent profiles, i.e. age, gender, problem list, meds and allergy list and possibly test results. The hospital needs to enter these patients into their own EHR system. According to Leapfrog, this is best done by admission folks, lab and radiology resources and maybe a pharmacist. Once the test patients are in the EHR, the hospital should log back into the “simulator” and print out about 50 medication orders for those test patients, along with instructions and a paper form for recording CPOE alerts. Once the paper artifacts are created, the hospital is supposed to enter all medication orders into the EHR and record any warnings generated by the EHR on the paper form provided by the “simulator”. This step is best done by a physician with experience in ordering meds in the EHR, but Leapfrog also suggests that the CMIO would be a good choice for entering orders. Finally, the recorded warnings are reentered into the Leapfrog web interface and the tool calculates and displays the hospital scores.

If the process above sounds familiar, it is probably because this is very similar to how CCHIT certifies clinical decision support in electronic prescribing. Preset test patients followed by application of test scripts are intended to verify, or in this case assess, which modules of medication decision support are activated and how the severity levels for each are configured. As Leapfrog’s disclaimer correctly states, this tool only tests the implementation, or configuration, of the system. This is a far cry from a flight simulator where pilot (physician) response is measured against simulated real life circumstances (busy ED, rounding, discharge). The only alarm the Leapfrog study is sounding, and it is an important alarm, is that most hospitals need to turn on more clinical decision support functionality.

It is not clear whether doctors will actually heed decision support warnings, or just ignore them. Since the medication orders are scripted, we have no way of knowing if, hampered by the user interface, docs without a script would end up ordering the wrong meds. And since the “simulator” is really not a simulator, we have no way of knowing if an unfriendly user interface caused the physician to enter the wrong frequency, or dose, or even the wrong medication (Leapfrog has no actual access to the EHR). We have no indication that the system actually recorded the orders as entered, subsequently displayed a correct medication list or transmitted the correct orders to the pharmacy. We cannot be certain that a decision support module which generates appropriate alerts for the test scripts, such as duplicate therapy, will not generate dozens of superfluous alerts in other cases. We do know that alerts are overridden in up to 96% of cases, so more is not necessarily better.
Do the high scoring hospitals have a higher rate of preventing errors, or do they just have more docs mindlessly dismissing more alerts?

All in all, the Leapfrog CPOE evaluation tool is a pretty blunt instrument. However, the notion of a flight simulator for EHRs is a good one. A software package that allows users to simulate response to lifelike presentations, and scores the interaction from beginning to end, accounting for both software performance and user proficiency, would facilitate a huge Leap forward in the quality of HIT. This would be an awesome example of true innovation.