Sunday, March 27, 2011

In Defense of EHR Weapons of Mass Destruction

Remember the fear mongering rhetoric about weapons of mass destruction and all sorts of other bogey men that sometimes led to war death and true destruction and other times to just animosity, hatred and counterproductive waste of time and resources? This is exactly what we are witnessing today in Health Information Technology (HIT). Granted this is only a sideshow, while the main stage is occupied by the unprecedented Federal push to computerize medicine, but it has a very shrill voice and it seems to be confusing many good people. There are many legitimate questions that need to be asked, many strategies that should be debated, many errors that must be corrected, but the unsubstantiated, dogmatic and repetitive accusations directed towards HIT in general, EHR in particular, and chiefly at technology vendors and their employees, are borderline pathological in nature.

To be clear here, there are many practicing physicians and nurses who are either forced by an employer to use an EHR they dislike, have tried to use an EHR and didn’t enjoy the experience, or are opposed to the EHR concept on principle because the software has no return on investment in their situation, is not “ready for prime time” or is too closely aligned with the goals of the Federal government. These are all valid points of view and should be listened to and considered by policy makers as well as technology builders, and I have to confess that I do agree with much of what these practicing folks write and say, and as I said many times in the past, practicing physicians, i.e. those who see patients every day, are dangerously underrepresented in all HIT policy and technology decisions being made now at a federal level. Unfortunately, the practicing doctors’ message is being obscured and tainted by the “naysayers who predictably and monotonically chant the “HIT is evil” mantra at every opportunity” (quoting the famed HIT blogger, Mr. Histalk). These “self-proclaimed experts” and their incendiary and largely self-serving monologues are making it very easy to dismiss legitimate problems present in HIT policy and technology.

The #1 allegation against EHRs and those who build them is probably the one contending that EHRs kill people. HIT is supposedly an unauthorized human subject experiment which should be halted due to so many deaths and injuries. There is no evidence to support this assertion. Yes, there are several deaths documented, which have been associated with EHR software in one way or another, all in hospitals, but there is no documented evidence of mass injuries. The ugly truth is that people die in hospitals due to preventable errors of all types. They died before EHRs were introduced and they are still dying at similar rates after EHRs were installed. For every error attributed to software malfunction, there is a parallel error that can be attributed to lack of software or utilization of paper charts in general. For example, a software bug could cause records to end up in the wrong chart. How many times do paper records get filed in the wrong chart? How many times do paper records get misplaced never to be found again? How many times do paper charts disappear for long periods of time?  Of course since paper is a passive medium, all errors arising from paper charts usage are directly attributable to users. When an EHR is used, some errors, not all and not most, are attributable to the software. Ergo, EHRs kill people while prior to EHRs people killed people. Net effect is the same, although fixing software bugs is a lot easier than remediating people’s error prone behaviors.

The #2 inflammatory allegation is squarely directed at the business entities that build and sell EHRs, and individually towards anybody associated with IT, whether at a hospital level or a vendor level. Supposedly, these dim-witted IT folks have no understanding of medical practice and a complete disregard for patient safety and human lives. I have no doubt that some IT folks would not score very well on Mensa tests and others may have little interest in anything other than their paycheck, and this is true about any randomly selected group of people, including clinicians. However, EHR vendors are for-profit technology companies, and as such have an overriding interest in creating revenue. You do not benefit your long term top-line by purposely selling defective products. Suggestions that EHRs should be produced by non-profits are a bit naive considering that this is health care we are talking about, and we all know how selfless, charitable and patient safety oriented other non-profits are in this industry. I would also like to point out the few and far between health care providers who are willing to treat Medicaid patients due to financial and business considerations. How are the sacred patient safety and human life considerations ranked by those providers? I would assume they come in right after staying in business, keeping the doors open and perhaps even an acceptable profit level. EHR vendors are no different.

As to hospital IT folks, the ones I had the pleasure of meeting always listed patient safety as their main concern. Was it just lip service? I don’t think so, but all I have is anecdotal evidence. In any case, the incompetence and profit concerns of hospital administrators who drive EHR deployments in hospitals and health systems, to the extent that they exist, are not indicative of HIT being murderous or evil. They are indicative of the need for transparency and learning from those that manage to deploy the same HIT tools successfully, and those do exist.

Moving on to #3, we find the widespread platitude contending that EHRs should be built “by doctors for doctors”. Guess what? Many are, and it doesn’t make those EHRs any better. Amongst the larger EHR vendors, there is none that does not employ physicians and some have dozens of MDs on staff and hundreds of other clinicians. Many medium and smaller EHR companies were founded, and some are still owned, by physicians. There are two issues here. One is that most physicians fully employed by technology companies are not practicing anymore and I am not certain they ever did after residency. I have personally witnessed multiple times the huge disconnect between the professional IT physicians and those seeing 30 patients each day. Couple that with the “I’m a doctor, so I know best” attitude, and you are guaranteed an academic product that will have little value in the “real world”. The second issue is that most physicians know as much about IT as engineers know about medicine. With very few exceptions, commercial EHRs should not be built by doctors as a side hobby. They should be built by professional software designers and builders with extensive input and guidance from customers, just like quality products are built in all other industries. And by customers, I don’t mean “ivory tower informatics experts” who happen to have an MD after their name. I mean hard working, six days a week, frazzled and discouraged, practicing doctors and nurses.

Finally the #4 issue is the perpetual cry from various quarters that EHRs should come under FDA supervision. I strongly agree. Any instrument used in the delivery of medical care should be supervised to an appropriate degree, and maybe such transparent supervision would put an end to the fictional assertions that EHRs are guilty of mass murder. Done right, FDA supervision will definitely help folks make better product choices and deploy and use EHR technology in more beneficial ways. With the recent proliferation of “certified” EHRs, triggered in large part by the glow of HITECH money, FDA supervision could also serve to separate the wheat from the increasing amounts of chaff. It is also useful to remember that people are killed every day by FDA approved drugs and devices due to improper use, human error, negligence, criminal intent and product faults that the FDA missed.

In conclusion I would be remiss if I did not mention the multiple legitimate complaints regarding EHR usability and utility. While there is much work to be done, many errors to be addressed and much technology innovation to be applied, the form and function of EHRs is ultimately dictated by the environment in which they are used. The business of medicine (a.k.a. billing) dictated most of the box-clicking nature of older EMRs and the new population health, cost cutting and research focus emanating from the Federal government will just increase the demand for structured data elements and the accompanying clicking on boxes. EHR vendors will build whatever customers are willing to buy. It is infinitely easier to build an EHR without click-boxes and templates, than it is to build one that records and maintains hundreds of templates, customizations, vocabularies, cross-walks, guide-lines, protocols and analytics to slice and dice everything. Vendors would be more than happy to just give you a blank text box where you can type, scribble or dictate to your heart's content. But guess what every single physician looking to buy an EHR is asking right after the price question? “How many templates does your system have for my specialty?” The structure of EHRs is a symptom of quite a different problem and it will not be resolved until the root cause is addressed. So the lunatic fringe notwithstanding, EHR vendors are not out there to torture you or kill your patients. They are out there to sell you products and services and make some money in the process - just like Apple, Microsoft, Google, IBM, and you - and they build the products based on what the customer says he wants and what the Government says they must.

And no, you don’t have to buy one if you choose not to………

Sunday, March 20, 2011

Unjust Enrichment

A new lawsuit has been filed this month in an attempt to curtail the unconsented and currently legal traffic of de-identified medical records, this time against pharmacy giant Walgreen. The class action suit brought by Todd Murphy, a citizen of the State of California, on behalf of his children, is alleging that Walgreen’s sale of prescription histories to data mining companies, servicing the marketing efforts of pharmaceutical companies, is an unfair, unlawful and deceptive business practice allowing Walgreen Co. to unjustly enrich itself while depriving the rightful owners of the data of their ability to benefit from the commercial value of their prescription records. There is no mention of privacy violations anywhere in the brief, and this is what makes this legal action very unique and potentially a landmark in the effort to control unauthorized sales of medical records.

The deceptive business practices are pretty straight forward to understand, since it seems that Walgreen makes all customers sign a privacy notice stating unequivocally that Walgreen will not disclose patient information without first obtaining authorization from the patient. Furthermore California law prohibits pharmacists from disclosing prescription information to unauthorized third parties, which arguably makes the sale of data also unlawful. The bulk of the brief is describing the injury to plaintiffs caused by “detailing”, i.e. targeted in-person marketing by pharmaceutical reps to physicians, which is substantially aided by information extracted from plaintiffs prescription patterns. Detailing is portrayed as a ruthless drug company strategy to increase sales of newer and more expensive brand-name drugs, thus increasing the costs of health care, endangering patients and harming the doctor-patient relationship.

And here is where the complaint gets interesting. The plaintiffs are arguing that “As a direct and proximate result of Defendant’s unfair business practices related to the sale of Plaintiff and the Class’ prescriptions as outlined above, Plaintiff and the Class have suffered injury in fact, lost money and/or property by paying money to Walgreen to fill their prescriptions, and been deprived of the commercial value and business opportunity inherent in the contents of Plaintiff and the Class’ prescriptions.” First, tangible injury is (hopefully) established. Second, if prescription data indeed has monetary value, and according to Walgreen’s SEC filling it is worth about three quarters of a billion dollars, then that money really belongs to the plaintiffs, which are seeking “That Defendant pay restitution, damages and / or disgorgement as proven for Walgreen’s conversion of Plaintiff’s prescription, and/or for restitution of monies paid Walgreen for filling prescriptions, and/or profits to be disgorged as unjust enrichment, and/or for the amount found to be due from defendant to plaintiff as a result of the accounting and interest on that amount from and after filing suit.”  If this action is successful, and it is established that medical data, whether identified or de-identified, is the property of the patient, and any proceeds from the sale of such data should flow back to the rightful owners, there will be very little incentive for Walgreen or any other medical records hosting entities to engage in wholesale of electronic health records.

The State of Vermont has a different opinion regarding data ownership. After a US Appeals Court ruled Vermont’s ban on the sale of prescription data unconstitutional on grounds of First Amendment violation, the US Supreme Court agreed to review the case. Vermont’s main concern is the sale of Prescriber Identifiable (PI) data and the ill effects of the resulting “detailing” on cost of care, physician privacy and doctor-patient relationship. Several “friend of the court” briefs filed in support of Vermont’s plea are also raising patient privacy issues and pointing out that de-identification, as performed by data-mining companies, is very likely reversible. Just like the recent Maine and New Hampshire laws, Vermont’s ban on prescription data sales to data-mining companies is enforced at the prescriber level (New Hampshire has a complete ban on sales, Maine allows prescribers to opt-out and Vermont proposes to allow doctors to opt-in).  While both Maine and Vermont laws assign control of PI prescription data to physicians, neither one proposes actual ownership, including commercial value compensation, to anyone other than those collecting the data in the first place. New Hampshire’s total ban on sales for detailing purposes implies that the State is in control of the data and nullifies any commercial value associated with this type of activity.

While the US Supreme Court review of the Vermont case is most certainly welcome, I don’t believe it will settle the general questions surrounding ownership of medical records. Watching Murphy v. Walgreen Co. winding its way through the various courts, as it certainly will unless summarily dismissed in San Diego County, should provide better intelligence, particularly regarding a legally acceptable definition of injury which is paramount to the success of this lawsuit. Hopefully others will bring similar actions and expand the scope beyond just prescription data. Physicians in particular would be well advised to consider the unjust enrichment of technology companies packaging and selling medical records composed by physicians who are investing large sums of money in the technology itself and are experiencing revenue losses due to decline in productivity and other software mishaps, all under threat of regulatory government penalties in the very near future. If this does not qualify as injury in a court of law, I don’t know what would.

Monday, March 14, 2011

A Speed Bump on the Road to Meaningful Use

Meaningful Use has hit a speed bump. It’s of the low, wide and gentle type, not the old raggedy, narrow and mean bump you find in older parking lots. Now that a tentative proposal for Meaningful Use Stage 2 has been published by ONC, and duly commented upon by the public, it just dawned on folks that there isn’t enough lead time between Stage 1 and Stage 2 to allow for an orderly transition, and here is the problem in a nutshell.

Meaningful Use is divided into three, increasingly more demanding, stages, starting in 2011 with Stage 1 and advancing every two years to a higher Stage. So 2013 marks the beginning of Stage2 and 2015 is the start of Stage 3. It seems that ONC and CMS need about a year and a half to define each Stage from start to finish, so if they start working on Stage 2 right after Stage 1 commences, there are only 6 months left for NIST to define certification criteria, EHR vendors to update their wares and certify them, and physician and hospitals to roll the new and improved products out. Oops……

The hand wringing in “industry experts’” circles began immediately after this realization, culminating with an Advisory Board publication advising hospitals in particular to not apply for Meaningful Use incentives in 2011, but instead wait for 2012, which they can do without penalty, and the same advice is applied to ambulatory practices owned by hospitals. They did not recommend anything for physicians in private practice. Since hospitals have a fiscal year starting on October 1st, three months before private practitioners, and Stage 2 Meaningful Use final ruling is not expected before the summer of 2012, it seems that hospitals are indeed at a greater disadvantage in that according to current regulation, providers must begin Meaningful Use reporting on the first day of their respective fiscal years. Stage 1, which was not finalized until late last summer, would have been a problem too, but the disaster was averted by CMS’s relaxation of requirements to only impose a 90 days Meaningful Use period in the first year, thus effectively pushing out the dreaded start date by up to 9 months. So should you wait for 2012? Before we shoot from the hip in panic, perhaps we should examine a few facts.

The tentative proposal for Stage 2 criteria as published by ONC contains very few new items. Most criteria are restricted to Stage 1 functionalities, but require clinicians to do more of the same. For example, if Stage 1 required that you record vital signs for 50% of patients, Stage 2 may require that you do that for 80%. This type of upping the ante does not require NIST to create new certification tests and does not require EHR vendors to write new software. Other Stage 1 criteria are not changed at all for Stage 2, and a few that used to be optional are now proposed to be mandatory. All these changes have no bearing on NIST, the vendors or the software. Let’s look then at the 10 “newish” requirements proposed for Stage 2.
  1. Clinical Decision Support (CDS) rules must originate from a reputable source and be properly deployed – CDS was part of Stage 1 and the Stage 2 qualification should already be implemented in any EHR worth anything. This is a non-issue unless you bought one of those fly-by-night certified EHRs, in which case you have much bigger problems than missing out on stimulus incentives.
  2. Advanced Directives recording is extended to physicians – This requirement was only for hospitals in Stage 1. Most decent EHRs already have this implemented and NIST has the test written.
  3. Electronic Notes – For hospitals, they allow the notes to be created by NPs and PAs. This is brand new and ONC will need to define what constitutes a Note and NIST will need to create a new certification test, but if your software does not allow you to document a visit note, you probably don’t use an EHR anyway.
  4. Track Meds in the eMAR – Is any hospital that is ready for Meaningful Use in 2011 not doing that already? Anyway, NIST will have some work to do here.
  5. Patient Portal – For Stage 2 there are several requirements that make having a Portal absolutely necessary. Most EHR vendors used their portals to certify for Stage 1, so again, not much work here for vendors, although NIST may have to tweak some tests. An interesting tidbit is that the Stage 2 proposals envision requiring physicians to make sure that 20% of their patients use the Portal. Not sure if I should laugh or cry, but I cannot see this particular requirement withstanding the rigors of a final ruling.
  6. Record Patient Communication Preferences – All but the quackiest EHRs already have this simple functionality. NIST will have to write a simple test.
  7. Care Team Members for each patient – Seriously? Anyway, this is insanely simple to do and simple to test.
  8. Longitudinal Care Plans - ONC is still trying to define what this means, but if everything evolves as it did in Stage 1, it will probably boil down to something like prescribing statins, or having a standing order for HbA1c every 3 months. No work for vendors and very little work for NIST.
  9. Health Information Exchange – This was required to be tested in Stage 1 and now it is required to establish actual connections. Nobody said anything about using those connections. I cannot imagine that this requirement will survive as written, but it should not require much effort from certified vendors and very little adjustments from NIST.
  10. Clinical Quality Measures (CQM) – The ONC proposal had no specifics here, but it stands to reason that they will be adding more measures in Stage 2. CQM has been the Meaningful Use Trojan Horse all along, so it will continue to be so. Unless tempered by reason, the new CQMs will require some doing from all stakeholders.
Contrary to the Advisory Board opinion, Stage 2 is nothing but an incremental change to Stage 1. Just like vendors did not sit idle while CMS and ONC were grinding the Stage 1 sausage, they will not be taken by surprise when the final Stage 2 rule is published either. However, even if enough vendors certify in time for the October 1st 2012 deadline, there is no way hospitals can be ready to move to Stage 2 on the appointed date, and very little chance that ambulatory offices will be ready to rock-and-roll by January 1st 2013.

The Meaningful Use workgroup at ONC held a meeting on March 8 and this very issue was raised. Surprisingly all participants calmly concluded that there are several possible solutions and one will be picked after proper consideration. Here are some of the options and my take on all of them.
  1. Push Stage 2 by one year closer to Stage 3 – Not a very good option for dealing with Stage 3 when the time comes, since the 2015 date is locked into statute and cannot be pushed.
  2. Allow folks to continue reporting on Stage 1 for the first 9 months of the 2013 fiscal year and begin Stage 2 reporting in the last 90 days of 2013 – This is reasonable, but a very complex structure for CMS to accommodate.
  3. Require only 90 days reporting for the first year of Stage 2, just like we did for Stage 1 – Simple, straightforward and my personal favorite.
Either way, hospitals and physicians should feel comfortable that an equitable solution will be forthcoming and there is nothing to be gained from postponing your 2011 attestation if, and only if, you are ready to go. ONC has shown time and again that it has an obvious interest in having as many certified vendors and as many Meaningful Users as possible, by consistently lowering the bar on problematic requirements. There is no reason to assume that ONC will refrain from doing so now. I may add that a bird in hand is worth two in the bush, and nobody knows what will happen to these incentives in 2012, which is an election year, and beyond.