The People’s Advocate at the Supreme Court Bar

H. Bartow Farr, III, Esq.

The Patient Protection and Affordable Care Act (PPACA) has finally met its challengers in the highest Court in the land and following the three days showdown, there’s nothing left but watchful waiting for the Supreme Court to hand down its final decision. All media outlets from left, right and supposedly middle are covering the events and hundreds of experts are ready to make predictions based on the inflections in one Justice’s voice. I made a point to not read any of that, and if you are an informed citizen who still insists on making his/her own mind, the very impartial SCOTUS blog is the place to go for links to the audio and transcripts of all oral arguments and all briefs submitted to the Court. By this logic you should probably not read what follows below either, but if you do, this is an unorthodox (neither left nor right) look at the proceedings from a citizen's point of view, a perspective that struck me as lacking in the proceedings themselves.

The main contenders were the Republican Governments of 26 States against a Federal Government controlled by a Democratic administration. There were also some private plaintiffs with a strong Libertarian argument, but their contribution to the subject is not clear to me, and is probably just a largely inconsequential sideshow. Generally speaking local governments were wrestling with central government in an outdated Federalist argument, where the people themselves have no standing.

The main event took place on Tuesday, March 27, where the constitutionality of the individual mandate, requiring every American to buy health insurance or pay a penalty, was argued, with the Federal Government arguing that its power to regulate interstate commerce includes the right to mandate that everybody buys health insurance, and if not, then the penalty should be viewed as a tax. The State Governments argued as expected that this gives the Feds unlimited power and a penalty is not a tax. The lively debate came complete with broccoli, burial insurance and babies being denied care at the hospital, hypotheticals. But here is what I found interesting: at the heart of the Federal Government argument was the contention that the uninsured are basically offloading their health care costs on the insured and society in general, therefore we must mandate that they buy insurance and pay their fair share. The States on the other hand, argued that forcing healthy people who don’t want to buy insurance to subsidize the sick is really not fair. Most Americans, as everybody agreed, are already purchasing health insurance, so who are these freeloading uninsured?

Well, it seems that 68% of the uninsured are under 140% of the Federal Poverty Level (FPL), and 95% of them are below 400% FPL. A full 45% of poor adults and 17% of poor children (under 100% FPL) are uninsured. Are these our freeloaders? Are these our interstate frequent travelers who impose huge uncompensated expenses on States where they don’t live? Are these poor people without insurance seeking out States that enacted guaranteed-issue and community rating insurance laws and move there en-masse? Is anybody else doing that? Do we even know what problem we are trying to solve?

Another pearl from the March 27 arguments was the realization that the States concede that the Federal Government has the power to require that people pay for health care with insurance. They only differ on the timing of buying the necessary insurance instrument, with the State Governments insisting that a free citizenry should have the right to purchase insurance en route to the ER, if they so choose, and the Feds arguing that they must buy insurance the day they are born. Does that mean that one cannot pay for health care with cash, or chickens? Will they check to see if you have insurance and if so, cash payments will be disallowed? What do you do if you’re one of the penalized? Do you get to pay cash, or do you get some services in return for all those penalties you paid into the system?

As interesting as the constitutionality arguments were, I found the session on severability to be most enlightening. On Wednesday, March 28, the Court grappled with the next steps, if the individual mandate is by any chance found to be an unprecedented and unlimited expansion of Congress powers and thus ruled unconstitutional. The 26 Republican governed States argued that the Court should throw out the entire Obamacare legislation with the mandate, because everything else in the PPACA is either hinging on the offending mandate or is unimportant. This is not surprising, since the war on the individual mandate, which is the brainchild of an ultraconservative foundation, is just a battle in a much larger war to remove the current Democratic President from office. The Federal Government began its arguments by mentioning the millions of citizens that are not standing before the Court and how the Court should nevertheless give them consideration. That was beautiful, but it didn’t last long, because eventually it became clear that the Federal Government is asking the Court to strike down both guaranteed-issue and community rating clauses along with the individual mandate, if found unconstitutional.

The Federal Government, true to form, was arguing on behalf of its insurance companies patrons. Unless the Feds can guarantee a certain number of customers, there is no way that insurers will agree to sell their wares in a non-discriminatory manner, because discrimination is how insurers make money, and no government should infringe upon basic rights of corporations. It fell to an attorney independently appointed by the Supreme Court to argue for the people, and (very eloquently) make the simple point that the purpose of the PPACA was not to provide customers to insurers, but to make health care affordable to all Americans, including poor and sick ones. The individual mandate is just one tool in an arsenal of tools to accomplish that end. It may be a very useful tool, but it’s not the only tool, and therefore if it is found unacceptable, it should be severed from the legislation and removed without throwing out the baby with the bathwater.

So the People finally got their 15 minutes in Court, represented by Court appointed counsel, as paupers usually are. Whatever the Court decides in this case, I will forever be grateful to the Supreme Court of the United States, the nine unelected Justices, who saw fit to solicit someone to speak for the People, something that neither States nor Federal Governments seemed to be too terribly inclined to do. And I am grateful that the Court chose H. Bartow Farr, III, Esq. to represent us in this matter, since his oral arguments were second to none, and may God grant the Court the wisdom to do what Mr. Farr advocated that they do, and the People shall prevail.

I Don’t Want To Be Digitized

I live in a bubble where everybody seems to be obsessed with Health Information Technology (HIT). The average man or woman you meet on any American street has no idea and no concern about the insurmountable difficulties associated with Electronic Health Records (EHR) and other HIT initiatives. I know because I asked random folks I encounter at the gas station, the dry cleaners, the supermarket, Starbucks, the grocery store and other mundane locations. It’s not a scientific survey, but it is disconcerting for me to realize that my days are consumed by something nobody cares about. I’d like to think that, although obscure, my endeavor could somehow better the condition of human kind, at least the portion of human kind that I can touch. To that end I come up with visions of a future where HIT enables millions of people to receive state of the art, truly personalized health care in thousands of small intimate locations filled with expertise and compassion, where everybody knows your name, and the computer knows your genome. Other folks in my bubble, probably for the same reason, are conjuring futuristic images of implantable sensors and long distance care delivered by artificial intelligence, with the occasional, and mostly preventable, acute episode addressed by robotic devices, supported by super computers in an operating room of the future.

Steve Jobs was an implementer. Gene Roddenberry was a visionary. There isn’t much technology out there today that was not envisioned by Mr. Roddenberry in his sci-fi odyssey through the infinite universe, and the most forward thinking idea tossed around now is Gene Roddenberry’s half century old notion of a tricorder, a hand held device that can evaluate health and diagnose disease in noninvasive ways. The Star Trek ethos presumes the existence of EHRs and HIT, just like it presumes the availability of all information ever recorded (Big Data?) in the all-powerful computer that speaks with Mrs. Roddenberry’s voice. We have a long way to go before the technology vision is fulfilled, but we have an even longer trek ahead of us before Earth becomes the hunger free, poverty free, greed free, egalitarian planetary bliss, where Mr. Roddenberry envisioned his technology to be operating for the common good.

The other day I was watching a recording of Dr. Eric Topol speaking to a group of Google engineers. The charismatic and super credentialed Dr. Topol has a new book out, and a vision of digitizing human beings in order to prevent and cure disease. Humanity has been engaged in a quest to prevent and cure disease since the dawn of civilization, and probably long before that. While the means to that end have steadily advanced from a patriarch blessing, to magic bracelets, secret potions and finally to chemicals and HIT, the goal remains the same: we don’t want to suffer and we don’t want to die, unless we choose to do so for a higher cause. While the word of God was usually identified as that higher cause, individual Liberty is the modern day call to arms, considered to be worth both suffering and death, but this too may change, because what is now mockingly referred to as “rugged individualism” is quickly giving way to consumers neatly aggregated in analytic hives of predictive similarity.

In the course of his Google presentation, Dr. Topol displayed a variety of cool technologies coming closer and closer to Gene Roddenberry’s tricorder, some that are already available to use and others still lurking in research labs. My fellow residents of the HIT bubble have probably heard of most of these iPhone enabled little miracles allowing one to turn his mobile phone into an ambulatory Intensive Care Unit to constantly monitor vital signs, activity, sleep patterns, items ingested and items excreted. Still in the making are widgets that can monitor your brain waves, your thoughts and other implantables capable of predicting disease before it actually manifests. A broad new horizon is opening up for Ari, an old friend of mine, who is a diagnosed hypochondriac, and until now was costing the socialized health care system in his country tens of thousands of dollars every year for EKGs alone, sometimes in the ER, and most of the time in an endless string of cardiology appointments.

In order for these things to be useful to more folks than just my old friend, they must be somehow tethered to a central command center, where the data is continuously analyzed and either the malfunctioning unit is warned of impending disaster, or better yet, actions are triggered to address the malfunction and restore the unit to normal operating parameters, based on individualized genomic data, other environmental and historical factors, and similar data points from millions of other humans. Obviously, engaging in such complex research and analytics requires that all monitoring data of all people is aggregated and considered by as many intellects as possible, which would be all of us in a sweeping wave of democratization of science placing the infallible wisdom of the collective above the fallible wisdom of any one individual. This is above and beyond Roddenberry’s wildest dreams. Or is it?

I’m afraid (truly afraid) that the glory must once again go to Gene Roddenberry and his crew. Although it took them a bit longer than the tricorder, they composed a detailed picture of a future where humanoids are outfitted with monitoring devices from birth and where crowdsourcing is the prevailing mechanism for collective governance and operations. They named those fictional people The Borg.

Where is Health Care’s Big Data?

The world of health care is abuzz with heated discussions about health information exchange, data liberation and the beneficial consequences of these actions to all stakeholders who use, deliver, regulate or profit from the one fifth of the U.S. economy devoted to medical care. While the efforts to liquefy health information from its solid paper state to a fluid stream of zeros and ones are hardly new, the release of the Meaningful Use Stage 2 proposed rules, has triggered a renewed Pavlovian response to the prospect of having people’s health information flowing freely over the Internet creating massive amounts of Big Data. Before the frenzy gets way ahead of itself, perhaps we should take a closer look at how health information is created, where it resides, how it is shared and what Meaningful Use Stage 2 is targeting for change. In short, let’s follow the Data…

Health Care Data Creation
Health information about an individual begins accumulating from the moment of birth, which is duly recorded when a tiny new consumer emerges into the world. Over one’s life, encounters with the medical system are carefully recorded and now, most of those encounters will be computerized. The following are the main sources of health data:

• Medical Care Providers – Hospitals, physicians, pharmacists, nurses, therapists and eventually long term care facilities are recording medical encounter information both for treatment and for financial purposes. The data created by health care providers is very rich in clinical information and also contains a significant amount of socio-economic details. Currently, medical information is scattered amongst all providers of health care encountered during a lifetime, and is mostly maintained on paper. Portions of it may or may not be exchanged in an ad-hoc fashion when people seek care at various medical facilities.
• Public and Private Payers – For the overwhelming majority of Americans who utilize insurance instruments to finance medical care, a lower fidelity version of health information is being maintained by the payer, mostly in electronic format, tallying ailments, therapies and everything else that has a dollar value associated with it.
• Ancillary Providers – From pharmacies to laboratories and imaging facilities, ancillary service providers are also maintaining lists of medical services and products provided to people and when pertinent, clinical results and invoicing information. This information is also largely maintained in electronic format.
• Personal Health – Although largely confined to a tiny minority of healthy, educated and tech savvy people, the results of personal monitoring of health indicators are beginning to accumulate in various private information systems. Currently most of this data is created by individuals outside the traditional medical system and is maintained and controlled by new and rather small technology vendors in electronic format.

Health Care Data Whereabouts
Obviously entities that create health data are also maintaining complete copies of said data for their records. However, large amounts of data are being exchanged currently between facilities of care, payers, diagnostic companies and government agencies, mostly in electronic format. As data moves around, and it does move, new repositories of data also emerge.

• Health Data Creators – Medical care providers, ancillary services providers and payers of all stripes store, maintain and supposedly own practically all health data created by their various business units and all copies of data created by others and transmitted to them during the course of business. There are significant overlaps between various data creators. For example, while payers do create financial data, all clinical information they possess is created and also stored by others.
• Public Health Agencies – Registries (e.g. immunizations, cancer, etc.) and other regulatory reporting repositories are also storing pieces of information transmitted to them by health data creators as required by State laws and vary greatly in availability and capabilities, but most information is electronically maintained.
• Clearinghouses – The facilitators of information exchange, mostly medical claims and payment data, medications, and to a lesser extent laboratory data, are also accumulating copies of whatever information is flowing through their systems in electronic format.
• Health Information Organizations – A special case of the clearinghouse model, these entities are mostly concerned with facilitating communications among regional health care providers, and in some cases are also undertaking data analysis services on behalf of their clients. As such, these organizations in many instances accumulate some portions of medical records data for some segments of the population in their geographical catchment areas.
• Technology Vendors – Those who supply electronic means to health data creators, and particularly the vendors who offer their technology in a remote service model, retain full access to their customers data, and for smaller customers, such as physicians in private practice, technology vendors are contractually reserving rights to make use of health data in a manner consistent with HIPAA regulations.
• Consumers – Aside from the emerging personal health monitoring devices and applications, a small minority of savvy consumers is also maintaining personal health records separately from their medical services providers, usually in remotely stored and web accessible repositories.

Meaningful Health Information Exchange
While Meaningful Use Stage 1 did not introduce any tangible breakthroughs in health information exchange beyond what was already occurring, the proposed Stage 2 measures are attempting to spur exchange of health data in several ways.

• Increase of exiting exchange – All thresholds for information exchange already in place, such as prescription data and laboratory results data, have been increased.
• Public Health Reporting – Actual reporting of data to government agencies is now required.
• Provider-to-provider – Some ad-hoc, point-to-point, standardized exchange of clinical summaries between various health care providers will be required.
• Provider-to/from-patient – In addition to requiring that physicians and hospitals provide health information to patients in electronic format, Meaningful Use Stage 2 places requirements on patients to contact their doctors by email and to access their electronic medical records online. The proposed rules stop short of mandating that patients actually copy their medical records themselves, or ship a copy to a third party recipient, but we have Stage 3 and onwards to look forward to. Either way, technology must be enabled to allow patients, or authorized entities (family, friends, other software, etc.) to extract copies of health information from the HIPAA covered entities where the data was created.

So where is the Big Data of health care? It is very likely that Meaningful Use Stage 2, along with accelerated Electronic Health Records adoption, will increase the size and number of current health data repositories, as well as the ad-hoc exchange of information between them. Changes in reimbursement models will also spur the slicing and dicing of health data, particularly for the purpose of risk management, but there is nothing in the proposed Meaningful Use Stage 2 rules to suggest wholesale merging of health data repositories, and on their own, none of them could be considered Big Data. What if we endeavor to index the contents of all repositories, per the PCAST model, and allow government, or other legitimate “stakeholders”, access to query every indexed and networked health data repository in the land? Is this the much touted and feverishly anticipated Big Data of health care? Meh… Something is still missing.

Big Data is not just lots and lots of data. Big Data is indeed big, but it is also very difficult to accommodate in traditional relational database systems. Big Data is very dynamic and changes fast, furiously and continuously, and Big Data is usually a combination of multiple unrelated sources; it is messy, inaccurate and needs lots of cleaning, processing and culling before it can be used. Well, we all know health care data is a royal mess, but other than that it has no other characteristics of Big Data. Some forward thinking clinical researchers, concerned with the ability of “decision makers” to make decisions for us, are suggesting that we make the data bigger by adding patient reported “psychosocial issues and health behavior”, which are usually outside the realm of medical care. They boldly envision doctors administering questionnaires to their patients to enrich the data sets obtainable by tying together “millions of encounters in real-world settings”. Not sure how you do that over disparate repositories without fully identifying each patient, but those are just details, and surely patients will see the value in allowing decision makers to assess our quality of life for comparative-effectiveness purposes. Anyway, adding some very patient-centered fields, quantifying your happiness or sadness, to the medical record is not going to elevate health care data to the status of Big Data. In order for health care data to become truly Big Data, it will have to be combined with other data sources, such as social media data, Internet search data, financial data, census data, shopping data, cell phone data, and the list goes on. And herein lies the Big excitement.

Of course, once we throw health care data into the boiling cauldron of Big Data, many wondrous things can emerge along with some nightmarish ones too. The only (legal) tool for extracting health care data from the HIPAA covered ecosystem today is the patient, because the patient is the only one who can legally “transmit” data from a covered entity to one that is not hampered by such details, like the various standalone Personal Health Records provided by private companies and all sorts of other health and wellness tools built by eager entrepreneurs. Once those shiny new “Transmit” buttons are added to patient portals, per Meaningful Use Stage 2 rules, there will no doubt be dozens of tools competing for “informed permission” from patients to crawl health care providers’ portals and auto extract everything possible and aggregate it “on behalf” of the patient. Will patients cooperate and donate personal health records to the Big Data enterprise? Perhaps a few, but not enough to make the bells ring. There will need to be a few more rounds of rulemaking before patient data can be truly liberated from those antiquated HIPAA protections, and properly used to build a few fortunes and to improve the quality and accuracy of the coupons we receive in the mail.

Parsimonious

I love persimmons with their luscious flavor and their rich exotic texture, but parsimony has nothing to do with persimmons. For the 99% of Americans who are less familiar with the term parsimonious than they are with the rare persimmon fruit, here are the suggested synonyms to parsimonious, according to the Merriam Webster dictionary: “cheap, chintzy, close, closefisted, mean, mingy, miserly, niggard, niggardly, stingy, penny-pinching, penurious, pinching, pinchpenny, spare, sparing, stinting, tight, tightfisted, uncharitable, ungenerous”.

In the sixth edition of its Ethics Manual, the American College of Physicians (ACP) is stating the following: “Physicians have a responsibility to practice effective and efficient health care and to use health care resources responsibly. Parsimonious care that utilizes the most efficient means to effectively diagnose a condition and treat a patient respects the need to use resources wisely and to help ensure that resources are equitably available” [emphasis added]. If you don’t use the term parsimonious in casual conversation, feel free to substitute any of the Merriam Webster synonyms, so you can enjoy the full flavor of this recommendation. We should note that the President of the ACP, Dr. Virginia Hood, while acknowledging that “it has some connotations where people think frugality or being parsimonious is the same as being mean or inadequate”, she does not “think that is the real meaning of that word". According to Dr. Hood “Parsimonious is a good word in the sense that it means that you use only what's necessary". Unfortunately she stopped short of defining “necessary”.

But the term parsimonious can be understood in a different way too. From the Latin “lex parsimoniae”, parsimonious, when scientifically understood could be a reference to Occam’s razor principle “requiring that the simplest of competing theories be preferred to the more complex or that explanations of unknown phenomena be sought first in terms of known quantities”. So perhaps the ACP is advising doctors to refrain from seeking zebras each time they hear galloping hooves, which may be fine medical advice up to the point where it requires respectful consideration for “resources”, which is just a polite term for money. When money is inserted into the scientific equation, we are drawn back to the penny-pinching definition, and since nobody wants to go on record advocating cheap care, we are back to parsimonious and the comfortable ambiguity cover it provides.

As noted in a recent New York Times article, despite this ambiguity, and perhaps precisely because of it, parsimonious care is quickly becoming a very popular term in the industry. In a NEJM article on costs of health care, Peter J. Neumann dares to ask the question and proceeds to answer it too: “Is “parsimonious” the right word? Perhaps there are better ones, but “frugal,” “prudent,” “thrifty,” “cost-conscious,” and others would also raise objections. … Calling it parsimonious is a reasonable start.” Yes, we can’t really call it what it is because it would raise objections. Similarly, we can’t call something a “tax” because it would raise objections, so we call it “penalty” instead, and this too is a reasonable start.

So what does parsimonious care look like? There are no exact descriptions, presumably because they too would raise “objections”, but there are philosophical principles involved. Dr. Zeke Emanuel, for example, is thrilled with the ACP daring to be “a professional society unafraid of advocating the principle of cost-effectiveness”. Cost-effectiveness, which has been in wide use before parsimonious came into vogue, is best examined at the edges where costs differ widely and effectiveness is held constant, or vice versa. It is prudent to stay away from instances where both costs and effectiveness vary widely in direct proportion to each other, because close scrutiny may raise objections. Perhaps this is where parsimonious care kicks in, invoking the renowned 80-20 business rule. If you get injured in an accident and we can restore you to 80% functionality for 20% of the cost, should we really spend the remainder 80% of the money for a measly 20% in diminishing returns to society? 

We may be able to gain additional insight by understanding what parsimonious care is not. A much debated recent study published in Health Affairs concludes that for office-based physicians, electronic access to imaging and lab results does not reduce the frequency of test orders, and advises that “[i]nsurers and health care providers should also be wary of claims that computerization alone will lead to a more parsimonious practice style”. Disregarding the policy implications and the validity of these conclusions, along with the vigorous rebuttals, and sticking with our largely semantic analysis, we may conclude that a reduction in ordering of expensive tests is a characteristic of parsimonious care. Examining the data in this study, which has not been questioned by those taking issue with the conclusions, one should be immediately struck by the fact that doctors in private solo practice are about four times less likely to order expensive imaging tests than physicians employed by hospitals, and significantly less likely to do so than doctors practicing in large group settings.

Since this particular study took the liberty of making some pretty wild assumptions, and since the rebuttals engaged in similarly wild predictions, perhaps it would be beneficial to disregard the multitude of controversial trees and observe the forest in plain view, which reveals that parsimonious care is more likely to be delivered in small private practice. The obligatory implications to policy makers would be to quit the mindless herding of doctors into unparsimonious hospital employment and consolidation, and to conduct some studies of readily available data on the parsimony, or cheapness, of care in various practice settings. The definition of parsimonious care, at least for ambulatory practice, as that which is offered in small private practice settings, and the promotion of the same, is guaranteed to not raise any objections from the public. The alternative would be to continue using terminology nobody understands to make policy nobody understands, while engaging in esoteric conversations for the illuminati who possess the encryption keys to public discourse.

Addendum: For the sake of completeness, here is the brand new response from the authors of the Health Affairs study on imaging, to the ONC rebuttal. (3/12/2012)

Opportunity for HIT Vendors to Do Good

Yesterday, I found an email from Health and Human Services (HHS) in my inbox highlighting a new initiative where the “Obama Administration and Text4Baby join forces to connect pregnant women and children to health coverage and information”. The goal of this partnership is “to promote enrollment in both Medicaid and the Children’s Health Insurance Program (CHIP)”. Having more babies and children obtain insurance coverage is obviously a worthy endeavor, and if it can be accomplished by simply sending informative text messages to pregnant women, even better. Of course having insurance coverage doesn’t always translate into having access to an actual doctor, particularly for Medicaid enrollees.

In an unrelated coincidental turn of events, it just so happened that I have had the recent opportunity to spend time with large numbers of Pediatric practices, most of which were small independent practices in middle-class suburban areas. The main goal of these conversations was to elicit doctors’ opinions on Electronic Health Records (EHR). As expected, only a small fraction of independent Pediatricians are currently using fully certified EHRs, and amongst those there is an even distribution of happy customers and disillusioned ones. A significant portion is actively engaged in purchasing EHRs, but the vast majority is pondering on what to do next. It turns out that one cannot have any discussions about EHR without sooner or later digressing to costs and precarious financial situations. Yes, EHR usability, or lack thereof, comes up in casual conversation, but by far most doctors understand that paper is over and computers are here to stay whether they are perfect or not. The barrier to jumping on the EHR bandwagon is always financial. Pediatrics in particular is not a very lucrative specialty and cash reserves are practically nonexistent in these small practices. 

And here is where I observed a very interesting and very positive trend. These suburban practices are considering opening their doors to Medicaid kids in larger and larger numbers. Both the recession and the possibility of obtaining enough government incentives to cover technology purchases are responsible for this trend, which I observed locally, but may very well be larger in scope. Pediatricians (and pediatric sub-specialists) are only eligible for Medicaid incentives and only eligible for the full incentive if at least 30% of their patients are covered by Medicaid. Meaningful Use incentives were aimed at providing a partial solution to the cost conundrum, of course, but there is a chicken and egg dilemma here. You can’t get the incentives unless you buy the EHR and you can’t buy the EHR unless you get the incentives, or take a loan, which is a very frightening alternative for most small practices and for many independent physicians whose personal wealth has been decimated in the last few years.

For illustration purposes, the total first year cost of an average EHR purchase, including training, implementation and hardware is around $100,000 for a practice of 5 physicians. Medicaid first year incentives for such a practice would almost to the penny cover the initial EHR costs. More importantly, Medicaid first year incentives are based on the administrative activities of buying the EHR and NOT on achievement of Meaningful Use. It doesn’t make sense to ask Medicaid to advance doctors $100,000 based on a promise to buy an EHR, and it would be unwise to have Medicaid send incentive checks to EHR vendors, but there is a third option, which provides EHR vendors with an opportunity to do well by doing good, for a change.

Here is how I would structure this transaction:

• EHR vendor in partnership with hardware vendor creates a bundled offering not to exceed the $21,000 per provider which is equal to the Medicaid first year incentive.
• Practice submits proof of eligibility for Medicaid maximum incentive to vendor
• Practice submits proof of registration with CMS and State Medicaid program
• Practice contractually obligates itself to attest to State Medicaid and submit proof of attestation to vendor within an agreed upon timeframe from contract signing (10 working days should be fine)
• Practice contractually obligates itself to remit full payment to vendor upon receipt of Medicaid incentives and no later than 6 months from contract signing

The value proposition to EHR (and hardware) vendors should be obvious considering that most of those who had the cash, already bought an EHR and the bulk of the remaining market is going to take its sweet good old time to “make a decision”. I do understand the implications of such arrangements to cash flow and balance sheets of technology vendors, but the competitive advantage to those larger vendors who can afford to make this offer would be big enough to warrant the costs, and the risk to the vendor is truly minimal. Yes, this would be similar to extending credit to the practice for six months, but psychologically this is very different, since there is much unwarranted mistrust amongst physicians that Medicaid will actually send them a check. Seeing that the vendor is willing to participate in taking the “risk” will generate significant and quantifiable good will.

The value proposition for society and the moms reached by Text4Baby is that the brand new coverage they are obtaining will actually come with a doctor happy to take care of their babies. Priceless.

EHR Certification 2014 Edition

As the Centers for Medicare and Medicaid Services (CMS) released their proposal for Meaningful Use Stage 2 requirements, the Office of the National Coordinator for Health Information Technology (ONC) released its updated requirements for EHR vendors intending to support Meaningful Use Stage 2. The document is chockfull of technical specifications and details which are probably more than any physician cares to know. There are, however, a couple of good reasons why you should have a general understanding of what your vendor, or soon to be vendor, is required to do because it will affect your finances and workflow and may also present some presumably unintended legal implications to your practice.

Terminology
The ONC proposal introduces several new terms that you should be aware of in order to avoid confusion, particularly if you are contemplating the purchase of an EHR in the next couple of years. A great slide deck from ONC can be viewed here.

• ONC HIT Certification Program – The EHR certification program has been renamed, so presumably any software you buy should state that it is ONC HIT Certified.
• CEHRT – Certified EHR Technology – This refers to any software product that has received any type of certification under the ONC HIT Certification Program. It could be a Complete EHR or a just a Module or a collection of Modules. Note that the “C” does not imply Complete. Any given CEHRT may or may not be enough to satisfy Meaningful Use (see below).
• 2011 Edition and 2014 Edition – ONC introduces the concept of Edition, since the certification criteria are different for 2011 and for 2014 and since it is expected that both versions could be available on the market concurrently. The Edition could be applied to a Complete EHR or an EHR Module.
• Base EHR – ONC is defining a Base EHR as a CEHRT that has several capabilities considered mandatory for Meaningful Use. Your software package must include a Base EHR even if you can exclude some of its functionality from attestation. It is not clear if software vendors will be required to clearly state if their offering includes a Base EHR, or if it will be left to the buyer to validate that it is so.

In an attempt to provide some flexibility, mainly to hospitals and specialists, it will no longer be necessary to purchase or assemble a Complete EHR in order to qualify for Meaningful Use. Instead one only needs a Base EHR, plus whatever Modules necessary to satisfy Core measures that you cannot exclude, and the particular Menu measures you choose. You can, of course still purchase a Complete EHR, and most primary care physicians will need to do just that, but if you don’t, you should exercise extra caution and read the labels very carefully.

Timeframe
If you are a proud recipient of a Meaningful Use incentive check, or soon to be one, you will have to advance to Stage 2 starting January 1st of 2014. Since the measures for Stage 2 are a bit more difficult and the data collection, particularly for Clinical Quality Measures (CQM), is a bit more extensive, it is imperative that you have your 2014 Edition installed and ready to learn and test sometime in the third quarter of 2013 at the very latest. Remember how long it took you to start your reporting period for Stage 1, and give yourself enough time to prepare for Stage 2, since you will be learning the ropes of Stage 2 while maintaining performance of Stage 1. There is no down time between Stages and there is no margin of error in consecutive 12 months reporting periods. If your EHR vendor has a sign-up list for Stage 2 upgrades, get on that list as soon as possible.

Features & Functionality
The proposed EHR certification criteria for a 2014 Edition require significant retooling of existing certified EHRs. For those with fond memories of the additional charges levied by many EHR vendors for Meaningful Use additions in 2011, this is a cautionary tale to be repeated in 2013. You should expect various Meaningful Use Stage 2 packages to be offered by your vendor and charged separately above and beyond your yearly maintenance or subscription fees. Below are just a few highlights and by no means a comprehensive list of proposed big ticket items.

CQM Reporting – If you had to pay separately for this in Stage 1, you should expect a requirement to upgrade to a more expensive version in Stage 2, since the computational requirements are much larger in scope now. If your current software does not have a registry capable of submitting CQM electronically to CMS, one will have to be provided to you for Stage 2, and this will also cost you more money. There will be an additional time burden imposed on you or your staff for collecting various data elements which were not required for Stage 1.

Referrals – Just having your referrals going out electronically and containing the required data elements will not be enough for Stage 2. ONC proposes that at least 10% of your referrals are sent outside your organization to entities that do not happen to have the same EHR brand as you do. I trust that large health systems will be successful in lobbying ONC to loosely define the term organization and/or for exclusions to this measure for their members. If this requirement remains in effect for independent private practice, you will have to add a technology profile to your clinical and patient preference considerations before you refer someone. Since your referral choices now carry clear financial implications for your practice (Meaningful Use incentives), where there were none before, a conflict of interest between you and your patient may have just been created. [Note: For those of you who have been skeptical and dismissive of my incessant warnings that an EHR will become the cost of doing business and its absence may exclude you from the health care marketplace, this is how it starts.] Considering the obvious issues with this requirement, I am very hopeful that it will be reworded in the final rule.

Patient controlled information transmittal – Obviously patients should have the right to send their medical records to whomever they wish, and obviously (to me) patients should have full access to their medical records to view and copy or download. Most practices are using web-based patient portals for exactly this purpose, and also to realize other administrative efficiencies. Meaningful Use Stage 2 adds a requirement that your patients have the ability, and actually exercise it, to transmit this information to a third party of their choice. This means that your EHR vendor will have to provide HIPAA compliant, Direct Project compliant, information exchange capabilities for all your patients. It is likely that large EHR vendors will undertake the entire task, while the surviving small vendors will contract this out.
Without boring you to death with public/private encryption keys and security certificates details, you need to know that this is going to cost you a pretty penny and that there may be legal implications for your practice. Allowing patients to download their information and be on their own from that point on, as in your current Portal, or the various Blue Button implementations, can be handled with proper disclaimers and warnings. This new Stage 2 feature proposes that your patients use your software tools, at your behest (need them to do this in order to get incentives) to send protected health information out to recipients you have no control over. If anything goes wrong, and many things can go wrong, are you, as the secure platform provider, legally responsible for any unfortunate outcomes? If a patient (who may not even be your patient) sends you unsolicited information via this mechanism, what are your legal obligations?
In addition, and exhibiting a perplexing misunderstanding of an NIH funded project to allow patients to grant and revoke provider credentials to imaging studies, ONC is also proposing to incorporate transmittal of large imaging studies by patients to third parties through the same mechanism. Hopefully, I don’t need to elaborate on the consequences to your network and software performance once DICOM images start flowing in and out freely through your Patient Portal.

I sincerely hope that enough public comments are submitted to ONC to change their well-intended, but fraught with unintended consequences, proposals for Meaningful Use Stage 2. I would also like to urge you to get involved, read the regulations and find the time to submit your comments, because whether you have an EHR right now or not, these regulations will sooner or later affect you personally. The time to sit on the sidelines moping and groaning, while hoping that this will all go away, has long since passed.

Note: Public comments can be made here.

Moving Up the Escalator to Stage 2

The eagerly awaited Notice of Proposed Rule Making (NPRM) on Meaningful Use Stage 2 has been finally released in a sprawling 455 pages document. If you followed the discussions of the Federal Advisory Committees over the last year or so, you would know that Meaningful Use Stage 2 is just another small step towards an overarching goal of utilizing health information technology to support current policies aimed at providing better care for individuals, better health for populations and lower the costs of health care. We can agree or disagree on the wisdom of those policies, but if you are using electronic health records or just contemplating a move to computerized records, and have an interest in obtaining Meaningful Use incentives or avoiding penalties, you should have a basic understanding of what the next step on the technology escalator consists of.

Meaningful Use Stage 2 distinguishes itself from Stage 1 mainly by proposing a major push to health information exchange. It also brings a new level of complexity to the assembly of various data sets that are intended to be exchanged with other care providers and/or patients. It would probably be a bit simpler to define one superset of information and use it for all information exchange measures. The other notable feature of Stage 2 is that a couple of measures are completely dependent on patients’ willingness and ability to engage in Internet based communications.

Basically everything that was required for Stage 1 is also required for Stage 2, although some measures have higher thresholds, and others have been consolidated in one measure, or are just implied in other measures. For physicians, Meaningful Use Stage 1 had 25 measures, of which 20 needed to be met. Stage 2 has 22 measures, of which 20 need to be fulfilled in order to qualify for incentives starting in 2014 (yes, 2014). There is still a bit of wiggle room, but not as much as in the past. Finally, just like in Stage 1, there are several exclusions available for measures that do not apply to your practice.
The following is an (almost) objective summary of the newly proposed measures.

The Departed
The following Stage 1 measures have been removed from the Stage 2 list for various reasons as described below,

• Maintain problem lists – incorporated into summary of care measure
• Maintain medication lists  – incorporated into summary of care measure
• Maintain drug allergy lists – incorporated into summary of care measure
• Perform drug formulary checks – incorporated into the electronic prescribing measure
• Drug-drug and drug-allergy interaction alerts – incorporated into the Clinical Decision Support measure

Golden Oldies
The following measures have not changed from Stage 1 to Stage 2, but those that were optional are now mandatory.

• Generate one list of patients with a specific condition
• Send reminders to 10% of patients (slight change: patients of all ages not seen in over two years)
• Provide patient education materials to patients stays at 10%

Wee Bit Harder

• Recording patient demographics increased to 80%
• Recording vitals increased to 80%
• Recording smoking status increased to 80%
• Electronic prescribing threshold up to 65% for ambulatory practice and newly added for hospital discharge medications at 10%
• Incorporate structured lab results into the EHR is up to 55%
• Medications reconciliation upon transition of care increased to 65%
• Recording existence of Advanced Directives has increased to more than 50% for hospitals only.

Full Step up the Escalator

• Computerized Physician Order Entry (CPOE) is now required for 60% of Medication orders, Laboratory orders and Radiology orders. Just to clarify, this is NOT a requirement to send orders out electronically. It is only a requirement to document the orders in the EHR.
• Clinical Decision Support (CDS) is increased to the implementation of 5 distinct rules, related to 5 or more CQM. This should not be a major problem for most EHRs, unless the final CQM are very different than what was offered in Stage 1. Enabling drug-drug and drug-allergy alerts are in addition to the above.
• Clinical summaries need to be made available to more than 50% of patients within 24 hours now, down from 3 days in Stage 1. Huge problem for those who don’t finish their charts on the same day. Clinical summaries should include at least the following items:
• Patient Name.
• Provider's name and office contact information.
• Date and location of the visit.
• Reason for the office visit.
• Current problem list and any updates to it.
• Current medication list and any updates to it.
• Current medication allergy list and any updates to it.
• Procedures performed during the visit.
• Immunizations or medications administered during the visit.
• Vital signs and any updates.
• Laboratory test results.
• List of diagnostic tests pending.
• Clinical instructions.
• Future appointments.
• Referrals to other providers.
• Future scheduled tests.
• Demographics (gender, race, ethnicity, date of birth, preferred language). (New requirement for Stage 2.)
• Smoking status (New requirement for Stage 2.)
• Care plan field, including goals and instructions. (New requirement for Stage 2.)
• Recommended patient decision aids (if applicable to the visit). (New requirement for Stage 2.)
• Submission of data to immunizations registries is no longer just a test. Stage 2 requires ongoing submission to a registry. Hopefully by Stage 2 the current mess, where hundreds of fully certified EHRs are incapable of connecting to registries in reality, will be resolved.
• Hospitals also need to have a working interface for lab results to public health entities, instead of just performing a test.
• Menu Item (ambulatory): Syndromic Surveillance interfaces need to be operational for Stage 2. For hospitals this is mandatory.
• Perform security risk assessment and remediation of deficiencies has not changed, but there is an explicit requirement to address “the encryption/security of data at rest”. So if you have your EHR server in your office, you will need your IT guy to pitch in a few hours here.
• Reporting clinical quality measures to CMS increased from 6 to 12 for ambulatory physicians and is up to 24 for hospitals. There are extensive lists of measures and a couple of choices on how to pick them. Note that there are several new measures and that CMS is expecting to be able to receive these reports electronically by 2014 and therefore CQM reporting will be separate from Meaningful Use attestation for Stage 2. Unlike Stage 1, physicians would be able to elect group reporting for CQM.

New and Noteworthy

• Hospitals must attest that 10% of medications are automatically tracked via an electronic medication administration record (eMAR).
• View/Download/Transmit – First, more than 50% of patients must have timely online access to their health information 4 days after it is received by physicians (36 hours after discharge for hospitals). Second, over 10% of your patients must view or download or transmit their information to a third party. This will require a Patient Portal that can log visits and an upgrade to most portals to allow transmission of records to somewhere. You will need to have over half of your patients registered for the Portal, which may be a problem if most of your patients don’t have email accounts, since most EHR supplied Patient Portals require an email for registration. Note that you must somehow ensure that 1 in 10 patients actually logs into their Patient Portal account and looks at the records. The Portal must make available the following items at the very least:
• Patient name.
• Provider's name and office contact information.
• Problem list.
• Procedures.
• Laboratory test results.
• Medication list.
• Medication allergy list.
• Vital signs (height, weight, blood pressure, BMI, growth charts).
• Smoking status.
• Demographic information (preferred language, gender, race, ethnicity, date of birth).
• Care plan field, including goals and instructions, and any additional known care team members beyond the referring or transitioning provider and the receiving provider.
• Secure messaging with over 10% of patients online is another new measure that can be satisfied by having a Patient Portal. The language for this new measure indicates that the secure messages must be sent by the patients, so as with the above measure, you will have to somehow ensure that your patients send you online messages.
• Summaries of care need to be transmitted for more than 65% of transitions or referrals. Of those over 10% must be transmitted electronically to someone not organizationally affiliated with you, AND that someone must use an EHR that is different than the one you are using. Choose your referrals wisely and make sure you inquire in advance about the EHR situation at the receiving end. You will probably have to type it in your EHR for record keeping purposes. If you work for a Kaiser-like organization, you may have a serious problem here.  Required data elements for these summaries are as follows (not sure why Meds and Allergies are excluded):
• Patient name.
• Referring or transitioning provider's name and office contact information (ambulatory only).
• Procedures.
• Relevant past diagnoses.
• Laboratory test results.
• Vital signs (height, weight, blood pressure, BMI, growth charts).
• Smoking status.
• Demographic information (preferred language, gender, race, ethnicity, date of birth).
• Care plan field, including goals and instructions, and any additional known care team members beyond the referring or transitioning provider and the receiving provider.
• Discharge instructions for hospitals.
• Menu Item: Availability of images in the EHR is required for over 40% of orders for all scans and tests whose result is an image. Many EHRs will need some retooling for this and you will need some expensive interfaces to hit the 40% threshold, particularly if you order imaging tests at multiple facilities, assuming those facilities have the ability (and willingness) to provide you access to their systems. The last thing you want to do here is to have those images travel over the network. It will kill your bandwidth and your server.
• Menu Item: Record Family History as structured data for over 20% of patients. This one is a walk in the park for practically all EHRs. Be sure to pick this one.
• Menu Item (ambulatory): Reporting to a Cancer Registry. This will require an operational interface for the entire reporting period.
• Menu Item (ambulatory): Reporting to a Specialized Registry (other than cancer). Here too a fully operational interface is needed. This is probably not much of a choice in most states.

If you managed to read to this point without falling asleep or suffering an anxiety attack, please note that this is just an NPRM and public comment is requested. Go ahead and make your opinions heard. CMS and ONC have listened to comments in the past and showed willingness to adjust. I would suspect that just like Meaningful Use Stage 1, these regulations will be much relaxed by the time the final rule is issued later this year, and further accommodations will be made as work in the field actually begins.

Note: Public comments can be posted here.