Saturday, December 24, 2011

The F Words of Health Care

Vassily Kandinsky, 1923
Fragmentation, Fee-for-service and Futile care are the trifecta of what is supposedly ailing our health care system, or non-system, as it is fashionably described nowadays. Modern health care has reached its crisis point not due to hordes of people keeling over and dying in the streets, as they did during historical health care crises brought on by plagues and famine, but due to exploding costs of delivering decent care to all people. Since the issue now is mostly financial, health care as a discipline is attracting the interests of those who practice the dismal science of Economics. Over the last two centuries, economists have successfully addressed the F words in other industries with spectacular results in developed countries, so why not apply lessons learned to health care? 

The obvious reason to treat economists with suspicion in health care is the quintessential argument that people are not widgets, but there is another problem. Most tried-and-true solutions for increasing availability and quality while lowering costs of products are not accounting for the other explosion occurring as we speak – the Internet.  How can this assertion be true when we are in the midst of a government sponsored spending spree to computerize medical records and adopt Health Information Technology (HIT)? Apparently, even those who lead and define the HIT revolution are reluctant (or unable) to grasp its full implication, thus they are consistently underestimating the power of the Internet to serve the individual, and as a result are hedging their bets on technology with classic industrial models from days gone by.

In a 2008 Health Affairs article, Dr. Donald Berwick has defined what has become the official goal of policy making for the Secretary of Health and Human Services. Better known as the Triple Aim, the goals are to create better health, provide better care and lower costs of care. If you look at health care as just another industry, the Triple Aim translates into a better product with a better process at a lower cost. Well, when put this way, the solution is pretty obvious and it has been obvious for over two centuries. We must address the F words: eliminate Fragmentation by aggregating independent artisans in one physical location, stop paying Fee-for-service (piecework) and pay salaries instead, and most important, eliminate Futile work by standardizing the process. In short, apply the industrial revolution to health care and realize the economies of scale that brought prosperity and happiness to the developed world. Except that for some strange reason, this solution doesn’t quite work in health care.

Case in point: Federally Qualified Health Centers (FQHC). FQHCs started out in the early 1960s as community run clinics to provide medical care to the poor. By the mid-nineties, and with the best of intentions, the Federal government and the Centers for Medicare & Medicaid Services (CMS), created funding grants and reimbursement methods to support these clinics. Today there are thousands of FQHCs of different types, operating in health care shortage areas and providing team-based comprehensive care including preventative care, basic primary care, behavioral care, dental care, lab and pharmacy services, mostly to Medicaid beneficiaries and the uninsured, but also to small numbers of Medicare and privately insured patients. FQHCs must use mid-levels to provide and coordinate care and must report on quality measures. In return, FQHCs receive millions of dollars in grants for building and improvements, have access to cost effective workforce, can obtain free malpractice protection, are tax exempt and are paid more than double what a private practice is paid for Medicaid services. By all accounts, FQHC are addressing the triple Fs of health care rather well, but how are they doing against the Triple Aim objectives?

Studies are mixed regarding quality of care provided by FQHCs, and patients cared for by FQHC are largely sicker than those seen in private practice. Interestingly enough, neither Medicare, nor privately insured patients are flocking to FQHCs, in spite of the financial advantages offered, particularly to Medicare patients, and in spite of the spiffy state of the art facilities. This may, or may not be, an indicator for perceived quality of care. How about lowering costs? Do FQHCs provide care at a lower cost than, say, an independent solo private practice?  Adding direct reimbursement rates, grants, tax breaks and other benefits, FQHCs visits cost more than twice the amount paid by Medicaid to private practices, which cannot compete with FQHCs and all but disappeared from areas where FQHCs operate. What would have been the results if twenty years ago CMS would have decided to increase Medicaid fees and pay for uninsured visits to independent practices, instead of exclusively backing the creation and operations of a separate but equal clinic system for the poor? We may never know for sure.

FQHCs are only a small example* of why economies of scale are not easily achieved in health care. Large hospital organizations and even fully integrated health systems, which may be providing better care (or not) seem equally incapable of reducing costs in spite of attacking all three Fs, or seeming to do so, and there are two reasons for this failure: a) larger health care facilities have disproportionately larger overhead costs and b) large systems are better equipped to charge more for services, which renders their efficiency efforts less urgent. And this is not a matter of opinion. CMS acknowledges this built-in inefficiency as evident in the physician fee schedule which pays an additional “facility fee” for services provided in hospital owned outpatient clinics, presumably to cover the extra overhead. Surprisingly, CMS is consistently creating incentives and regulations to accelerate provider consolidation into these big inefficient and expensive systems. The only possible explanation would be that CMS is betting that elimination of the last two Fs (Fee-for-service and Futile care) will be easier in a consolidated environment and the gains will ultimately exceed the losses from doing away with independent practice (Fragmentation). What about information technology? Well, it is supposed to help with process standardization, data collection and performance measurements, similar to what computers do in every other industry.

We have all seen the infomercials for high-tech hospitals, where a bunch of doctors are seated around a conference room table, each holding a laptop or tablet, presumably discussing patients in a team environment. There is something very wrong with these pictures. First, it costs us a fortune to have all these physicians in one room. Second, there is almost no added utility for them to be using computers instead of passing around a piece of paper, and computers are expensive. Third, there is no patient in the room. Now let’s imagine a different picture: a primary care physician sitting in his office, with a patient next to him, both interacting with a computer on which a Skype conference is taking place with an oncologist sitting in his own office thirty miles away, a surgeon in a hospital lounge in the city and perhaps a radiologist half a continent away. Everybody on the call has access to the same electronic medical record, appointments can be made in real time, literature can be consulted and shared, prescriptions can be changed and a common care plan agreed upon by all and understood by all can be created and by using intelligent predictive analytics tools various options can be explored. Perhaps a family member in a different country is conferenced in and perhaps the patient is at home or in a break room at work. Perhaps there’s an electronic sign-up sheet for the oncologist, if the patient wants to ask something else later and have a physician friend in New Zealand listen in. And with one click on a PayPal button all doctors are paid for their time.

In this Internet age, manufacturing style physical consolidation is not only unnecessary, it is cost prohibitive. Modern lifestyles and modern medicine have created a need for doctors and patients to collaborate and the Internet is providing the means to accomplish such collaboration without having to physically gather everybody under one expensive roof. There is no need to obliterate the operational efficiencies of private practice and replace it with the bloated bureaucracy of large institutions, and there is no need to dispense with long lasting doctor-patient relationships in favor of computerized care coordination, and there is absolutely no need to substitute a bunch of numbers in a computer for a real patient. The Internet is decentralizing and individualizing everything from politics to manufacturing. Health care is, and always has been, decentralized, individualized and based on the local patient-doctor dyad. The resemblance is striking. We either embrace the fully aligned collaborative nature of the Internet to achieve better health, better care at lower costs, or engage in a doomed effort to impose an unnatural centralized command and control structure in health care just because it worked well for nineteen century steel manufacturing and because policy makers don’t truly understand the magnitude of the connectivity revolution.

* According to the Kaiser Family Foundation FQHCs had about $12.7 Billion in revenues in 2010, 75% of which came from Federal and State agencies. They served almost 19.5 million patients with over 77 million encounters. Simple math yields a cost of approximately $165 per encounter.

Monday, December 5, 2011

The Pin Factory EHR

In 1776 Adam Smith explained to posterity how specialization increases productivity using the now famous example of a pin factory. While one master pin maker could turn out anywhere between 1 and 20 pins each day, going through all the steps involved in making pins all by himself, a specialized army of laborers, each fulfilling one step in the pin making process, could increase productivity more than two hundred fold and turn out almost 5000 pins per person per day. This would have the triple benefit of enriching the factory owner, creating jobs and making pins both affordable and widely available for consumers. What happened to the master pin maker, who used to make a very nice living when pins were expensive and hard to come by? He would most likely be employed in the factory to supervise the smooth flow and quality of the new pin mass production system. He would make sure that each laborer works at a speed appropriate for feeding the next laborer in line and he would probably sample a few pins here and there to make sure they are as sharp and sturdy as the ones he used to make in the olden days. When the master pin maker passes away a new supervisor would be hired, most likely one that has never made an entire pin before, but instead has a much better understanding of the production process. The profession of pin coordinator has been born.

Although Adam Smith put forward the notion of specialized labor, Henry Ford is customarily credited with the invention of the modern assembly line. Interestingly, Ford is attributing his invention to the observation of Chicago’s meat packing industry. It seems that while no two cows are identical, the butchering of animal life lends itself rather well to disassembly line methodology. Today, manufacturing assembly lines use human labor where it is cheap and in abundant supply, and are staffed with robotic machinery where human labor is expensive and/or scarce. In all cases the process is orchestrated and controlled by sophisticated computer software. This is why we are all able to purchase a car, chat on our cell phones and enjoy perpetually fresh slices of white bread in plastic bags, amongst many other wonderful things, which were once only available to the wealthy few.

Modern medical care is increasingly out of reach of most people. It is expensive, and adequate resources are scarce in many areas. Medical care also varies widely in quality, and the costs of production are anybody’s best guess, depending on geography, time of year and even workers vacation and education schedules. This is very much the same as making pins in the eighteen century. In all fairness, some specialization of labor has already occurred in medicine, but there is no coherent method of placing each worker in his/her station of the continuum of care, and there is no standard process by which workers hand off work from station to station. According to experts, this lack of orderly processing, along with the absence of quality control, is creating a terrible waste of resources and a flurry of defects in the finished products. If the advanced methodologies of modern day manufacturing are working so well for everything from cars to pins to cows, wouldn’t it make sense that we should at least try them in medicine?

Fortunately, we already have several pieces of the puzzle in the works. As mentioned above, we do have a certain degree of specialization in medical practice. We also have hospitals, which could function very much like factories, but as Clayton Christensen observes, most have no well-defined assembly lines. And then, of course, we still have the independent small shops that take piece-work home and operate without any standardized quality control. We also have the beginnings of computerized control systems in the form of Electronic Health Records (EHRs), which, according to John Halamka, are quickly moving from just bookkeeping software to dynamic coordination of processes, complete with encyclopedic knowledge of medicine and a good measure of artificial intelligence to devise and “enforce automated care plans”. 

The only thing left to do is to lay out proper assembly lines, and we don’t really need to think outside the box too much, because manufacturing has solutions for this dilemma as well. In modern industry, there are practically no factories that start out with raw materials and end up with a finished product. Instead, some factories concentrate on producing parts and others are built to receive parts and assemble them into useful products. Exact specifications for each part, to be followed by production lines and relied upon by assembly lines, make this geographically dispersed process possible. In health care, the primary care homes will serve as production centers, where people are constantly measured, tracked, tested and evaluated, so when they are finally shipped to a hospital for a procedure, the hospital knows immediately which assembly line to place them on and the omniscient EHR will control the most minute detail in the process, from medication dosing to incision size and implantable device brand and model, thus reducing both errors and costs. Once the hospital’s work is done, patients are released back to evaluation and management in production centers, and here is where the cyclical nature of health care differs from a typical manufacturing process, and this is why it is extremely important that EHRs be interconnected and preferably Cloud based to achieve a high degree of omnipresence.

Yes, there are many more details to be worked out, like emergencies, accidents and the exact specifications that an EHR should contain on each type of person. We will have to establish quality feedback loops between hospitals and primary care centers to continuously refine processes for both entity types, so basically the EHR will need to be able to adapt to, and learn from, new information, in a manner similar to IBM’s Watson software. Since people are not pins or even cars, the tolerance levels (allowed deviation from specs) will be high initially, so line workers will need to be highly skilled as well. In all likelihood physicians will be working those lines for the foreseeable future. As the learning control system improves, portions of work would be offloaded to less skilled resources and eventually to machines, and more significantly, entire tasks could be packaged into deterministic protocols and pushed out from expensive hospitals to the less skilled primary care production centers, which will further push the most trivial tasks to consumer owned devices.

Obviously, EHRs will prove to be the heart, brain and circulatory system, of the health care industry. As we speak, EHRs are increasingly being tasked with care coordination activities (not to be confused with continuity of care, or longitudinal care), which are the precursor to the industrial line controller. Folks wondering why they should use EHRs that are not ready for prime time, should understand that we have to have an EHR in every practice, so that the system can have visibility into current processes to learn, adapt, grow and devise new methods of providing care. After all, you cannot control that which you cannot see. 

If you think this is all farfetched and disastrous, please find a senior citizen that lived through the Great Depression and ask her what she thinks about dinner being prepared moths in advance in computer controlled industrial vats, thousands of miles away from home, pumped full of preserving chemicals, freeze dried, shrink wrapped and delivered by airplane to a football field size department store, with minimal human intervention, ending up in a small irradiation chamber in your home before it hits your dining table (or couch). Yet we all buy the stuff and feed it to our kids with no apologies, because it is cheaper, faster and more convenient than tenderly preparing beef stroganoff and baking pot pie at home, after work, every day. And neither grandma nor you can even fathom the handcrafting of pins by master artisans. Is health care really that much different?

Thursday, December 1, 2011

2011 EHR Adoption Rates

On Wednesday, November 30, the Centers for Disease Control and Prevention (CDC) released the results of its yearly survey on Electronic Health Records (EHR) adoption for office-based physicians. No surprises. Generally speaking, the majority of physicians in ambulatory practice are now using an EHR, and over half of surveyed doctors say that they intend to seek Meaningful Use incentives. The report is also presenting results broken down by State, so you can learn what folks are doing in your immediate vicinity. The more instructive exercise is to compare last year’s survey results [Fig. 1] to this year’s estimated EHR adoption numbers [Fig. 2].

Figure 1: Percentage of office-based based physicians with EHR - 2010
Figure 2: Percentage of office-based physicians with EHR - 2011

The most immediate observation is that 6.2% of physicians have adopted an EHR in 2011, thus returning to EHR growth rates preceding the 2009 -2010 slowdown, which was largely due to the confusion created by Meaningful Use regulations. The next observation is that the percentage of docs that have at least a basic EHR has gone up by 8.9% in 2011. A basic EHR is one that has “patient history and demographics, patient problem list, physician clinical notes, comprehensive list of patient's medications and allergies, computerized orders for prescriptions, and ability to view laboratory and imaging results electronically”. Although the survey instrument in 2011 did ask about more advanced functionality, and is practically identical to the 2010 instrument, the CDC did not publish a separate number for those with fully functional systems in 2011. Although I cannot be certain, I would assume that most of the growth in 2011 was fueled by Certified EHRs, which by definition should be fully functional. So if I had to guess, and I hope CDC will release the numbers so I don’t have to, I would estimate that in 2011 we have at least 20% of physicians using fully functional systems, which is roughly double what we had in 2010.

Another interesting trend that has been holding since around 2007 is that about a quarter of office-based doctors have some type of bare bones software in their office and they are not upgrading to even a basic EHR. Considering that over half of those surveyed intend to apply for Meaningful Use incentives, this trend is bound to change in 2012.  Some of these folks may have purchased a fully featured EHR, but chose to either not turn features on or chose not to keep up with upgrades to newer versions. For ambulatory EHR vendors these numbers translate into a market opportunity ranging from 50% of the market to a full 80% of ambulatory physicians.

It would be very beneficial if CDC released the complete data set from this survey (anonymised, of course), so we could gain a better understanding of EHR adoption patterns by practice type, size and location. Although it is widely acknowledged that larger practices and employed physicians are further along the curve, the rich details provided by the survey instrument should help both vendors and various organizations engaged in efforts to spur technology adoption, better target their work, and it could also illuminate any disparities which may affect quality of care for vulnerable populations and physicians who serve them.

In summary, the new CDC survey is showing a stable growth in technology use by office-based physicians, modestly improved by government initiatives over the last two years, and well positioned to further improve in 2012 and beyond.

Sunday, November 20, 2011

Thanksgiving in Health Care

Thanksgiving is almost here and between shopping for yams and turkeys and waiting for the cranberries to pop in the saucepan, there is ample time for reflection. Most folks evaluate the past year and make predictions for the next somewhere around Christmas, but since little serious business is conducted after Thanksgiving, and I’d rather leave predictions to professional gamblers, this is the week where I sift through this year’s events and try very hard to elicit personal feelings of gratitude. Since this is a health care blog, here are some health care related things I am very thankful for, and since like most social media aficionados, I too have a very short attention span, most are rather recent events.
  • First and foremost I would like to thank the Supreme Court of the United States for agreeing to hear arguments from the States, the Federal Government and small businesses backed by large businesses, on the Patient Protection and Affordable Care Act (PPACA) (a.k.a. Obamacare). Although having PPACA end up in front of the Supreme Court was a foregone conclusion since before the ink was dry on the President’s signature, and perhaps long before that, I am particularly grateful for the Supreme Court’s chosen timing for making a decision on this matter. The Court will hear arguments early in the spring of 2012, and if all goes according to plan it will either uphold or obliterate President Obama’s most important policy achievement just in time to inform my decision on who to vote for in the Presidential elections. It means a lot to me, and I am sure to many other conflicted voters, to have the advice of the wisest nine men and women in the land, and it is much more elegant and efficient to mentor us now instead of having to fix the issue after the elections take place.
  • Second, I would like to express my gratitude to Walmart who is finally volunteering to extend its unparalleled efficiencies in supply chain management to health care. Like most Americans, I have seen my health insurance premium go up by almost 20% recently and my deductible has too many zeros to fit in that little box on a standard check. It is reassuring to know that very soon Walmart will do for health care what it did for tee-shirts and accessories. Obviously, any organization that can put a plastic Luis Vuitton handbag in the hands of the humblest day laborer can surely be relied upon to bring PSA testing and chronic disease management to every hamlet and every housing project in the land. And even though I have no plans to start shopping at Walmart, particularly for health care, I am looking forward to the proven Walmart effect on prices of medical products and wages, which should make all health care, affordable for all of us.
  • On a more technical, and more work related note, I need to thank the FDA for unequivocally excluding Electronic Health Records (EHR) from its proposed regulation of mobile medical applications. The mobile health (mHealth) field is in its infancy and chock full of bright eyed and bushy tailed young entrepreneurs who can obviously benefit from FDA guidance just like their brethren in the perpetually sizzling bio-tech and device industry already do, with more innovation than any investor can handle percolating up all day every day. On the other hand, the frail and elderly EHR field, led by billion dollar technology and insurance companies, is in no position to withstand the rigors of FDA regulatory activities, which may inadvertently interfere with the massive life supporting cash infusion from government initiatives.
  • For a closely related effort, I am also grateful to the Institute of Medicine (IOM) for its recent report supporting the FDA position on EHR regulation. While acknowledging the inherent patient safety issues posed by use of EHR devices, the IOM is proposing a tangled web of voluntary and non-regulatory boards and organizations to be created for the purpose of observing and guiding EHR product use and development. The IOM does recognize that the system it proposes may very well fail to address the issue at hand, in which case it recommends that the FDA comes in to the rescue as a last resort. Hopefully by then EHR companies will have had every chance to absorb the Federal flow of cash to the industry in its entirety.
  • A few days ago we observed Veterans Day and we all expressed our heartfelt thanks for the sacrifices made by our men and women in the armed services. I would also like to thank Congress and its Super Committees for going above and beyond gratitude, and actively trying to provide our Veterans, even those who are too old, too depressed or otherwise incapacitated, with one more chance to serve our country. As we sink deeper and deeper in debt, there is a great opportunity for millions of heroes to forgo a little bit of health care services, or pay a bit more for each, so the greatest nation on earth can save a whopping $11 billion each year. Compared to putting oneself in harm’s way, this is easy stuff and while it is true that one large corporation, like GE for example, could single handedly create those savings just by paying their taxes for the year, it is much more meaningful that the glory should go to our Veterans. It is the right thing to do and I am so proud of our honorable members of Congress.
  • Finally, I would like to thank Congress one more time for perhaps the most extraordinary achievement in its history, and that is transforming pizza into a vegetable. Granted the Supreme Court of 1893 paved the way by declaring the tomato fruit to be a vegetable, but combining white flour and globs of animal fat into the texture of this new vegetable is nothing short of miraculous. Although Congress accomplished this in the context of ensuring that our children eat healthy food in school cafeterias, I am certain that many adults and most children will incorporate more of this wonderfully healthy vegetable in their diets outside of school lunch, and I for one, will try very hard to find a creative way to add this Congressional vegetable to our Thanksgiving table this year.
Now that I thanked all I could think of, and before I return to my bubbling cranberry sauce, I would like to ask for one little thing. Bypassing the Congressional middlemen, and going straight to the top, I would like to ask Hershey and Nestlé and all other multi-national decision makers, if it would be possible to make chocolate a vegetable too. Since cocoa beans grow on trees, chocolate is practically a fruit as it is, so making it a vegetable should be trivial in view of the various precedents quoted above, and it would mean so much to me and to countless other women and children trying hard to take personal responsibility for their own health and health care.
Happy Thanksgiving everybody!

Wednesday, November 9, 2011

The IOM Report on Health IT Safety

A recent report from the Institute of Medicine (IOM),  “Health IT and Patient Safety: Building Safer Systems for Better Care”, introduces a new health care related term, "Health IT-assisted care", defined as "health care and services that incorporate and take advantage of health information technologies and health information exchange for the purpose of improving the processes and outcomes of health care services. Health IT–assisted care includes care supported by and involving EHRs, clinical decision support, computerized provider order entry, health information exchange, patient engagement technologies, and other health information technology used in clinical care”. And the IOM report, as its title implies, is recommending strategies to ensure that health IT-assisted care is safe for patients.

The IOM report presents a comprehensive literature review regarding the status of health IT as it pertains to patient safety from every conceivable angle, starting with the manufacturing process and drilling down into product selection, implementation processes, training, and actual use of EHRs and other health IT products. As most folks who follow the health IT industry know all too well, the report concludes that data concerning the effects of health IT on patient safety is currently scarce and inconclusive. Nevertheless, the scarcity of data and the “sparse evidence pertaining to the volume and types of patient safety risks related to health IT” did not prevent the committee from acquiring “the sense that potentially harmful situations and adverse events caused by IT were often not recognized and, even when they were recognized, usually not reported”. That maybe so and again it may be that what we see is all there is to see. Either way, “[t]he committee believes the current state of safety and health IT is not acceptable; specificactions[sic] are required to improve the safety of health IT”. To that end, the report presents 10 recommendations to the Secretary of Health and Human Services (HHS).
  1. HHS should create and publish an action plan in the next 12 months to assess the risk of health IT for patient safety and begin mitigation through education, research, standardization and the testing and accreditation of health IT products. Suggested organizations for funding and carrying out these activities are ONC, AHRQ and NLM.
  2. HHS should insure that health IT vendors freely exchange information regarding issues as they pertain to patient safety. This is where the infamous gag clauses in EHR contracts should be addressed.
  3. ONC should work with public and private sectors to make user reports of patient safety issues publicly available. NCQA and JCAHO are amongst the suggested implementers.
  4. HHS should fund the creation of a new Health IT Safety Council to evaluate criteria for measuring safety of health IT.
  5. ONC should require all health IT vendors to publicly register with the agency.
  6. HHS should define mandatory quality management processes for health IT vendors. ONC, FDA and certification bodies are suggested organizations for administering a compliance process.
  7. HHS should establish a mechanism for reporting adverse events which is mandatory for vendors and voluntary for users. Reports should be collected analyzed and acted upon.
  8. Congress should create an independent federal entity, similar to the National Transportation Safety Board (NTSB), to investigate the reports collected in item 7 above.
  9. HHS should monitor progress and if found lacking, should direct the FDA to exercise its full authority to regulate health IT. The FDA should immediately begin preparing the infrastructure for this eventuality.
  10. HHS should support cross disciplinary research of safety aspects of health IT, such as user centered design, safe implementation methods, sociotechnical systems, and effects of policy decisions on health IT.
This is a very impressive and very well-reasoned list of tactical and strategic initiatives, but it also presents some difficulties. First, reporting adverse events is a prerequisite to almost all activities recommended by the committee. It is not clear how such reporting is to be implemented when malpractice suits are a consideration. The report suggests that reports should be kept private, even anonymised, and that users should be protected from punitive actions. Does this protection extend to legal action? If the report-collection agency becomes aware that a patient died due to preventable error, should the patient’s family be notified? Should malpractice attorneys be allowed to review this public information and subpoena the identifiable data? Second, all ten recommendations made by IOM require significant funding and it is not clear where the monies should come from at the moment. The recommendation in item 9 above, that the FDA readies itself for full regulation of health IT as a contingency plan if all else fails, seems duplicative and particularly wasteful. Somehow the committee seems to believe that FDA regulation, unlike regulation by multiple disjointed organizations, would negatively affect anticipated innovation in health IT.

Speaking of the FDA, the immediate question, of course, is why do we need a 137 page report from the IOM to figure out how and who should oversee patient safety? The Food and Drug Administration (FDA) is currently overseeing patient safety issues arising from surgery-assisted care, radiology-assisted care, pharmaceutical-assisted care, implantable device-assisted care and all sorts of other types of assisted care. Most recently the FDA published its proposal to oversee mobile device-assisted care (phones, tablets and laptops). How and why is health IT-assisted care different? How is a medication dosing calculator on an iPhone different than the same calculator in an EHR? How is an iPhone connected to a blood pressure cuff different than an EHR connected to a blood pressure cuff?

To my immeasurable delight, the IOM report contains the answer in the Dissent Statement of Dr. Richard Cook. While the IOM report is recommending that health IT be regulated and monitored by a smorgasbord of existing or yet to be created organizations, none of which have the required expertise to tackle the task, and all of which will need to be heavily funded for this endeavor, with the FDA as a last resort measure, Dr. Cook proposes to allow the FDA to do its job in the first place.  Dr. Cook’s simple and straightforward recommendation is to have HHS “direct the FDA to exercise its authority to regulate health IT, including all EHRs and associated components, and health information exchanges, as Class III medical devices”. While possessing all salient characteristics of a Class III device, “health IT is on track to be a medical device used for every person in the United States” [italics in the original], which makes it both urgent and imperative to have health IT regulated and monitored properly and Dr. Cook's conclusion succinctly sums it all up: "health IT is a medical device. It should be regulated as a medical device now and should have been regulated as a medical device in the past".

Sunday, October 30, 2011

EHR Adoption is Like Treating Cancer

EHRs are not ready for prime time. EHR benefits are questionable and there are documented instances where patients’ deaths were directly attributed to an EHR. EHRs are cumbersome and slow. They are unnecessarily complex and built on very old technology. The people who build EHRs have no concern for the end user and therefore EHR usability is pretty abysmal. And EHRs are expensive to buy and expensive to maintain, not to mention that they can completely derail your practice through loss of productivity. The fact that some users seem to do well with their EHRs, and even derive some joy from using them, is not a valid counter argument since most users are not so fortunate and through no fault of their own. There really is no excuse for such failure in this day and age. Just look at the iPad and the iPhone. You can walk into any Apple store and 5 minutes later walk out with a fully functional product with a delightful, intuitive interface, loaded with hundreds of interchangeable apps that even a three year old can use right out of the box. All for a few hundred bucks.

If you happen to be diagnosed with cancer, you will most likely be subjected to years of unpleasant treatments. You will be injected with poison and irradiated with more poison. You will lose your hair, suffer bouts of vomiting and diarrhea and be physically debilitated to the point where you cannot leave your bed. You will most likely have to go through painful surgeries, take all sorts of medications that were shown to kill thousands of rodents and never recover your old self again. And this entire ordeal will cost you a medium size fortune. The fact that some lucky patients go on to win the Tour de France is not really an acceptable rebuttal. Most do not. And there really is no excuse for such incompetence in this day and age when one little pill can cure you of an yeast infection in 24 hours and a $4 course of antibiotics will render you as good as new if you happen to develop a sinus infection. Not to mention the innumerable vaccines that will miraculously prevent you from contracting the plague.

Yes, this is a farfetched analogy, but replacing paper charts with an EHR is not like playing Angry Birds, and if you want a fair chance at survival, you have to tolerate the side effects imposed by the current state of technology. Just like you cannot postpone your cancer treatment until the doctor from Star Trek figures it all out, you cannot postpone transition to EHR until EHRs are “ready for prime time”.  And make no mistake, in today’s reality, paper charts are as big a threat to the survival of an independent medical practice, as any garden variety cancer is to a human body. Paper charts will gradually and irreversibly deprive your practice from the nutrients and oxygen needed for survival, i.e. reimbursement, until it shrivels and dies, or it gets absorbed into a larger organism. The common wisdom seems to favor these outcomes. I do not. If you are one of the fewer and fewer physicians who has no desire to either shrivel or practice Wal-Mart medicine, here is one way to think about your current EHR predicament. [Note: Considering the gravity of the situation, you would be well advised to seek a second opinion.]

Diagnosis – Look around you. EHRs are slowly gaining ground. You would be hard pressed to find a medical group of significant size that does not have one. Data collection is not as voluntary as it is being portrayed, unless of course you think that you are overpaid and can easily absorb cuts in reimbursement. You can choose to make believe that this too shall pass and once Obama is no longer calling the White House home, all will be as it was. Alas, computerization of medical records has bipartisan support, and it always did, due to a rare alignment of powerful financial interests and progressive ideology. If you want to continue the practice of medicine, you will need to use the tools of the trade. For better or worse, both the trade and its tools are being redefined. Barring a global disaster, the chances of spontaneous remission are nil.

Staging – How bad is it doc? Well, it won’t kill you tomorrow, but the longer you wait, the harder and more expensive it will become, the fewer the choices and the lower the chances of a good outcome. Both public and private payers are experimenting with new reimbursement methods. These pilots, or projects, are cropping up everywhere, supported by grants and all sorts of tax payer monies. The goals may be different and the rules of engagement are certainly different, but these arrangements have one thing in common. They all prefer that you generate and consume large amounts of clinical data in electronic format. You will need an EHR for that.

Treatment – A physician-centered approach to the problem suggests that you should be informed of your options and allowed to make a decision based on your personal and cultural preferences. Since medical practices are not people, you may choose to euthanize your practice. This may make perfect sense if your practice had a long and productive life and your medical career is in its twilight years anyway. A less terminal option would be to allow your practice to be hooked up to the machinery available in large health systems. You will still have to use an EHR, but your new employer will undertake the mitigation of most side effects. There is a slim chance that someday you may be able to remove the tubes and resume private practice, but while your medical career can survive indefinitely, your practice as you know it now is not likely to recover. Or you could make a stand and fight for your independence.

Prognosis – By definition there could be no blinded trials for EHR utilization, and by omission there are no randomized control trial results to learn from. The anecdotal evidence suggests that many thousands of physicians in independent practice are surviving just fine after EHR implementation. Some would say that they are doing better than ever now, and others have resigned to the new ways of doing business. For most, the life threatening problem has been transformed into a manageable chronic condition. It must be noted however, that a significant number of physicians is currently in need of life-support from health systems and hospitals, and many of these are post EHR implementation. We cannot be certain, since there is almost no literature on the subject, but it is highly probable that practices suffering from a relapse have had multiple comorbidities to start with and/or developed other life threatening conditions since. There are no guarantees of course, but if you have an otherwise healthy practice, a positive outlook and a supportive environment, chances are good that transition to EHR now will enable your independent practice to survive and thrive for many years to come. And the opposite is also true.

Sunday, October 16, 2011

EHR Bargains Review – Practice Fusion

(Survival Tips for Small Practices)

If you subscribe to Prof. Clayton Christensen’s theories of innovation, Practice Fusion is to the EHR industry what Southwest Airlines was to the air travel industry, ad extremis, with no thrills, no frills and no peanuts. Practice Fusion is completely and truly free to users, and it will take you from point A to point B in a straight and short line, with point A being paper charts and point B being a Meaningful Use incentive check.

The Model

Practice Fusion is a web-based EHR and it is free to use no matter who you are. The company website has a self-provisioning button where any visitor can sign up for a free account and immediately start using the software. All you need is a valid email address. The company prides itself in taking users live on the EHR in 5 minutes. It actually takes much less than 5 minutes to get to a point where you can begin charting, but it takes a week or more to hook up to electronic prescribing and lab interfaces, and this is very much in line with industry practice. Practice Fusion offers free connectivity to national reference labs and a handful of regional ones as well. Just like there are no charges for electronic prescribing, there are no interface fees for the currently available lab connections and no mention of “custom” interfaces built for a fee. You get only what you see.

Since we all know that there is no free lunch, how is it possible to get a free EHR, including significant interoperability? The standard answer to this is that Practice Fusion is ad supported. Just like you get free email services from Google in return for agreeing to see ads on every email page, when you sign up for Practice Fusion, you are agreeing to see ads on every EHR page. To my pleasant surprise, the ads are mostly limited to about one inch of space at the bottom of the screen, and are not at all intrusive in the workflow. I actually don’t quite see how these ads support anything, since with the exception of one Dell advertisement they all seem to be Practice Fusion self-promotions. Furthermore, the fairly new Patient Fusion portal displays no ads at all. Similar to most other EHRs, the Practice Fusion end user agreement reserves the right for the vendor to aggregate and monetize EHR data, and perhaps this is a possible explanation for this free lunch.


The best description for Practice Fusion’s functionality is bare-bones. There is no fluff, no bells and no whistles to be found in the very simple, very clean user interface. After muddling through a variety of top-shelf EHRs with double and triple menu-bars and icon studded task-bars on every page, the Spartan look & feel of Practice Fusion is quite refreshing. Although there are multiple training aids in the system, if you are an average computer user (e.g. email, Word), you should not need much coaching to become productive at very short notice. This of course eliminates another hefty expense associated with EHR adoption: training.

Whatever free-form stuff you are now doing on paper, you can do in Practice Fusion, pretty much the same way. It comes with a simple set of SOAP templates consisting mostly of questions where you get to type in the free text response. You can also type directly into the note and probably use Dragon as well. You can create your own sets of questions, or add to existing ones. You can order meds, labs and imaging and print those, or send electronically if connected. Scanned documents can be uploaded to any particular chart. There is no clinical content available for decision support, at this time. Registry functions are in their infancy and the handful of available reports is very simplistic. Disappointingly, the Meaningful Use report does not automatically calculate numerators and denominators for core and menu items, but clinical quality reporting is automated. There is very little customization possible and none is required.

For patients, there is Patient Fusion, a simple web-based portal that allows patients to see appointments, meds, allergies, immunizations and labs. It also provides some links to medical content on the web. It seems that the portal is very much a work in progress, but just like the EHR, its user interface is clean, simple and appealing. Unlike the EHR, which is Flash based and therefore unavailable for use on Apple mobile devices, the portal is accessible from an iPhone or an iPad. Practice Fusion did announce recently that a native version of its EHR for the iPhone is due to be released soon. 


Practice Fusion is privately owned and has been around since 2005, but started taking off in earnest around 2009. Its recent growth coincides with the HITECH act and the advent of Meaningful Use. Although it is possible that it will follow a trajectory similar to Southwest Airlines and blossom into a major EHR vendor, it is also possible that it would make a rather attractive acquisition target for one of the much bigger fish circling health care IT right now. Will it remain free to end users? There seems to be no current intent to charge customers for software usage, but Practice Fusion received over $36 million in venture capital, which usually comes with expectations of short term spectacular returns. Time will tell.

Bottom Line

Practice Fusion is currently certified for Meaningful use as a Complete EHR, which means that you don’t have to buy additional software in order to achieve Meaningful Use requirements. As is the case with all web-based EHRs, you will have to buy desktop (or mobile) hardware, internet services and networking hardware. You will still need to pay for a Practice Management system and billing, and unless you choose to utilize the sole Practice Fusion partner for these activities, you will need to budget staff time for double data entry. You will not need to pay for the EHR, its server and its maintenance. If you are interested in Meaningful Use incentives, and if you practice in a small group, and if the cost of EHR seems prohibitive (or a waste of good money), and if you have no use for bells and whistles above and beyond a paper chart, then by all means, go ahead and try it out. It’s free.

Friday, October 14, 2011

Occupy Health Care

Earlier this year, in the midst of the civil unrest in Egypt, Michael Millenson pondered about the passive attitude of those lacking health care insurance and their failure to organize and “take to the streets”. Well, unless you are living under a rock, or are really busy seeing patients, you know that we have quite a few people “taking to the streets” nowadays. They call themselves the 99% and they are set to Occupy Wall Street along with a bunch of other cities across the country. They have been called everything from “the rise of a popular movement” to “anti-American”. Are these Michael Millenson’s uninsured finally standing up for themselves? Judging from the stories they write on the placards covering their faces, which look eerily similar to what you see at busy urban intersections (e.g. “Lost home and job, will work for food”), lack of health insurance is often cited as a source of misery, but so are student loans, lost savings and inability to find work. Although this peaceful movement of folks camping out in parks and marching down streets has no coherent message, their grievances are casting a large net directed at the destructive influence of Wall Street, big corporations and consumerism in general. Michael Millenson should be satisfied, since health care is most definitely included in this all-encompassing indictment of an unjust society, and here is why.

But first a little detour into terminology. The word “care” originates from the Old English caru, cearu "sorrow, anxiety, grief," also "serious mental attention" for the noun, and carian, cearian "be anxious, grieve; to feel concern or interest" for the verb. When it comes to one’s health, with the exception of patients, their loved ones and increasingly fewer and fewer doctors, nobody in the medical complex experiences any feelings of anxiety, grief or even true interest or concern for the sick, although they may experience all of the above for the cash flow associated with treating sick people. The term health care is an anachronism from a bygone era and it needs to be changed. Health Services seems a much better fit with the prevailing consumer philosophy, which brings us to the next point.

Ever so gradually and insidiously, the term consumer is replacing the term patient in health services contexts, just like it replaced the term people in larger contexts. The etymology for the word consumer dates back to the early 15th century as "one who squanders or wastes", and in economic sense, "one who uses up goods or articles (opposite of producer) from 1745”. Interestingly enough those who presumably advocate for poor and vulnerable populations and even our own government are enthusiastically standing up for their constituencies of squanderers and wasters. Sometimes terminology describes existing realities and sometimes carefully chosen terminology shapes reality. We are witnessing the latter. The big corporations being targeted by those who Occupy Wall Street, have a long, and productive, history of manipulating the 99% into using up as many goods and articles as possible, and then some (i.e. debt), while extracting both profit and power from an increasingly impoverished society. Squandering and wasting is the secret sauce for a consumerist world order, and the medical complex is no different. According to Forbes, in the midst of a recession, CEO pay has increased in 2011 by 28% compared to 2010. The highest paid CEO in America, at $131 million per year (twice as much as the second CEO on the list), is running a health services company. Makes perfect sense. After all health services are quickly approaching 20% of a successful wasting and squandering economy. $131 million is peanuts by comparison.

But here the big corporations are encountering a big problem. The U.S. government, that is supporting a large portion of the waste and squander in the health services sector, is running out of money, and the squanderers themselves seem unwilling to waste their own money on health services. They much rather debt finance homes, cars and iPhones than, say, colonoscopies and designer drugs. The solution to this quandary is a brilliant one-two punch. First we use the bought and paid for government to educate consumers that in a world of finite resources, after skimming the $131 million type “compensations” from the top, only those who have their own resources (i.e. cash) should expect to continue wasting and squandering health services. Second, to compensate for lost revenue from government’s support of health services consumption, we employ two, time tested, strategies. We convert non-consumers to consumers by giving them free small things to lure them into buying more expensive items. For example, we give out free cholesterol screenings so we can create a recurring revenue stream from statins and hopefully more expensive interventions down the road. After all there is a huge untapped market of 50% of Americans who barely use any health services.  Then we increase the prices of everything from health insurance to direct services, by eliminate those obnoxious small businesses floundering in this space and fragmenting our ability to negotiate higher prices. The government is of course expected to help with the necessary laws and regulations, and so far, keep your fingers crossed, it’s going rather well. With a little bit of luck, smart consumers will soon realize that it is in their best interest to spend money they don’t have on the medical complex rather than the real estate market, which has gotten more than its share already, or the high tech gadget market which is booming, or the automotive market which is dead anyway (except for Audi who is selling cars for a crumbling infrastructure littered with trash). It’s all about reallocating extortion revenue and nobody is in a better position to do that than the medical complex. Brilliant indeed.

As the ancient prophet said “What has been will be again, what has been done will be done again; there is nothing new under the sun” [Ecclesiastes 1:9], all of the above has been tried before, in this case by the legendary Mullah Nasreddin, and we know how it ends:

One winter Nasreddin had very little money. His crops had been very bad that year, and he had to live very cheaply. He gave his donkey less food, and when after two days the donkey looked just the same, he said to himself, "The donkey was used to eating a lot. Now he is quickly getting used to eating less; and soon he will get used to living on almost nothing."
Each day Nasreddin gave the donkey a little less food, until it was hardly eating anything. Then one day, when the donkey was going to market with a loan
[sic] of wood on its back, it suddenly died. "How unlucky I am," said Nasreddin. "Just when my donkey had got used to eating hardly anything, it came to the end of its days in this world."

To the 99% of us donkeys out there: Occupy Health Care Now!

Sunday, October 9, 2011

The Rise of Big Data

Health care is in the process of getting itself computerized. Fashionably late to the party, health care is making a big entrance into the information age, because health care is well positioned to become a big player in the ongoing Big Data game. In case you haven’t noticed computerized health care, which used to be the realm of obscure and mostly small companies, is now attracting interest from household names such as IBM, Google, AT&T, Verizon and Microsoft, just to name a few. The amount and quality of Big Data that health care can bring to the table is tremendous and it complements the business activities of many large technology players. We all know about paper charts currently being transformed via electronic medical records to computerized data, but what exactly is Big Data? Is it lots and lots of data? Yes, but that’s not all it is.

Americans live for approximately 78 years. They see a doctor about 4 times per year and spend on average 0.6 days each year in a hospital. To keep a life time record of blood pressure readings for all Americans, including metadata (date/time of reading, who recorded the measure and where, etc.) takes approximately 6 TB (terabytes) of storage space, or about 12 laptops with standard 600 GB hard drives. Not too big. What if we start using mobile wearable devices to quantify ourselves, as some folks already do, and we record blood pressure, say, every hour? We will require 1460 TB of storage, or almost 3000 laptops, or the equivalent of 6 times the digitized contents of the Library of Congress, and this is for blood pressure monitoring only. Adding in the remaining 99.9% of the medical record, including large imaging files, hospital monitoring devices, pharmacy data, insurer data, telehealth sessions and other personal health sensors, and keeping in mind that all these data are meant to be exchanged freely over the Internet, we are approaching a data tsunami of biblical proportions. And we are not done just yet. Once health care’s Big Data is released into the mainstream Internet, it will initiate secondary and tertiary waves of new data created by consumers addressing their newly found health care data on social media venues, specialty forums, blogs and commercial sites offering services for health data. Big Data is the fluid combination of the ever increasing real-time data streams created by everything from government to businesses to Facebook, Twitter, Geo-locators, mobile devices and connected sensors everywhere. Big Data is as much about size as it is about cross pollination of data from disparate sources.

A fascinating June 2011, McKinsey report predicts that Big Data is the “next frontier for innovation, competition, and productivity” and that Big Data will become equal to labor and capital in its importance to production. For U.S. health care, the report is predicting $300 billion per year in savings due to utilization of Big Data to drive the execution of strategies proposed by health care experts. In the area of clinical operations, the report lists projected savings from Comparative Effectiveness Research (CER) when tied to insurance coverage, Clinical Decision Support (CDS) savings derived from delegating work to lower paid resources and from reductions in adverse events, transparency for consumers in the form of quality reports for physicians and hospitals, home monitoring devices including pills that report back when they are ingested, and profiling patients for managed care interventions. Administrative savings are projected from automated systems to detect and reduce fraud and from shifting to outcomes based reimbursement for providers and, interestingly, for drug manufacturers through collective bargaining by insurers. Most savings listed under research and development opportunities from Big Data seem to accrue to pharmaceutical and device manufacturers. There is nothing to suggest that Big Data will somehow reduce unit prices of products or services.

To be honest, I don’t quite understand where the $300 billion in savings come from as there are no actual itemized numbers to support this prediction. In addition to stated reliance on individual studies and expert interviews, there are many structural assumptions regarding massive provider consolidation, proliferation of Accountable Care Organizations, technology adoption rates of 90% across the industry and data sharing amongst all stakeholders, at which point Big Data will come in and do its thing. The costs for generating, storing and analyzing Big Data which include emerging data storage technologies and analytical expertise are factored in, with the costs of national deployment of EHRs alone “estimated at around $20 billion a year, after initial deployment (estimated at up to $200 billion)”.

Most people, including doctors, will probably agree that pertinent data, big or small, can be transformed into pertinent information, and pertinent information is vital to good decision making. But is Big Data pertinent? Are all those petabytes of minute details about everything and everybody really useful, or are we just mixing a little wheat with a lot of chaff? There are various opinions on this, but the prevailing wisdom seems to be that the more data you have, the more likely you are to be able to extract something useful out of it. By observing patterns and correlations in this ocean of information you may discover answers to questions you wouldn’t have known to ask in the first place. There is much power in Big Data, but there is also danger. As big as Big Data may be, it does not guarantee that it is complete or accurate, which may lead to equally incomplete and inaccurate observations. Big Data is not available to all and is not created by all in equal amounts, which may lead to undue power for Big Data holders and misrepresentation of interests for those who do not generate enough Big Data. Collection and analysis of Big Data has obvious implications to privacy and human rights. But the biggest danger of all, in my opinion, is the forthcoming relaxations in the rigors of accepted scientific methods, and none seems bigger than the temptation to infer causality from correlation.

We’ve been there before. When humanity dwelt in caves and villages, correlation was enough to establish causality. We’ve come a long way since, but the global village we are creating today seems tempted to go back to observation as the main way of gaining understanding. Just like the historic villagers, we are now convinced that we can see everything there is to be seen; therefore the answers to all our questions must be found in the Big Data mirror we placed in front of us. All we have to do is stare at it long enough and the patterns will emerge. The sheer size and variety of Big Data will make it much easier to reject the null hypothesis and see patterns where none exist. On the other hand, if we keep staring at our digital selves in the eye for long enough, perhaps we will achieve the most coveted observation of all: a glimpse through the windows to our digitized soul.

Sunday, October 2, 2011

Who Should Pay for EHRs?

During the 2008 Presidential campaign, Candidate Obama promised an EHR for every American by 2014. The goal was to improve quality of care, reduce disparities and contain costs of health care. When the HITECH act became law in 2009, physicians found themselves under increased pressure to purchase an EHR. Many took action, went out and bought an EHR for their practice, and these are now well positioned to collect the financial incentives put forward by the HITECH act. Many more did not. EHRs are by and large a complex and expensive proposition and the HITECH incentives are not covering the average cost of purchasing and maintaining an EHR. In survey after survey, physicians consistently rank cost associated with EHRs as their top concern when considering transition from paper charts to electronic medical records. This is a bit disconcerting, since physicians have no problem buying other expensive tools and paying for human resources in their practices. How are EHRs any different?

Non physicians usually attribute this reluctance to computerize medical records to technophobia or a perverse need to keep patients uninformed in order to maintain power and perhaps even financial advantages. Physicians on the other hand, mostly argue that EHRs do not benefit them directly and therefore they should not be expected to use them, let alone pay for them. Since there is no evidence of physician technophobia in any other areas of medicine (or private life) and since there is no measurable benefit to doctors in keeping their patients in a subservient position, the question then becomes: who is benefiting from EHRs?

There are three primary stakeholders in health care: those who receive care, those who provide care and those who manage the financial aspects of health care, and no, we are not getting into the quintessential argument of whether there should be only two primary stakeholders. There are several secondary stakeholders as well: those who manufacture medical goods, those who provide ancillary services and those engaged in medical research.

Historically, an EHR has been defined as a software tool, used by health care providers to collect, analyze, display and exchange clinical information with others. The content collected in an EHR was exclusively generated by health care providers or by traditional ancillary service providers (e.g. labs, imaging, etc.). There is however a new type of ancillary service providers aiming to provide services directly to patients, mostly through mobile devices, who are clamoring for the right to become an accepted partner to the EHR clinical information exchange network. And of course patients, whether through these new ancillary service providers or directly, are also increasingly voicing a desire to be included in clinical information exchange. These developments are altering the classic definition of an EHR and changing the focus from tools to provide care to broad content management, which is more in line with Candidate Obama’s vision. In reality all these functions are still in their infancy, but the direction is fairly clear, and it is worth noting that unless all functions are optimally performed, there is not much benefit accruing to any stakeholder. Various constituencies may derive more value from one particular function rather than the others, but as long as that value exceeds what is made available by a paper system, someone should be willing to pay for it. Let’s examine our stakeholders, and their willingness to pay, from the bottom up.

Secondary Stakeholders – Here we find the drug and device manufacturers and the bewildering array of diagnostic facilities. Most of these companies are largely indifferent to what EHRs do and some stand to lose revenue when EHRs shine bright lights on spending patterns. They are not likely to consider paying anything for widespread EHR adoption. On the other hand, the mushrooming mobile health and personal health application providers, who base their entire existence on the availability and successful use of EHRs, show no willingness to share in the cost of computerizing medical records. Needless to say that medical research centers which have been habituated to mostly free access to data sources, may be willing to pay data aggregators, but would never consider participation in infrastructure investments.

Health Insurance Providers – The largest health insurance provider in this country is the Federal Government through the Centers for Medicare and Medicaid Services (CMS), and CMS is proposing to bear a rather hefty portion of the costs of EHR deployments. Obviously CMS is expecting to see great financial rewards from a fully functional EHR network. Whether CMS is placing onerous or misguided requirements on the technology is a completely different question and one has to keep in mind that CMS is primarily a payer and its primary concern must be proper stewardship of tax payer funds. To do that, CMS needs data, and lots of it. You don’t usually pay a mechanic to take a look at your car – you pay him to fix it. CMS is now paying health care providers to treat people and it would much rather pay them to fix people and keep them under warranty, and it would also prefer that this is done via a fixed price contract, instead of the current time & materials model. EHRs are the tools by which quality assurance is performed and deliverables are accounted for and measured.

What’s good for the goose should be good for the gander, and private insurers figured out that paying for EHRs may not be such a bad idea after all. I am not 100% certain, but I would suspect that financing EHRs for physicians in order to improve quality of care falls under the medical expenditures rubric and can be deducted from the federally imposed Medical Loss Ratios (MLR). Since private insurers have historically ran much tighter ships than CMS, I would expect that in return for their Stark exempt contribution to EHR expenses, private insurers will ask for at least as much data as CMS and probably a lot more.

Health Care Providers – These folks are as diverse as the patients they serve, but their interests in EHR are most closely correlated to their size, which ranges from the solo doc in a micro practice to integrated delivery networks serving millions of patients. For large providers who operate multiple and varied facilities of care, EHRs are a tool to effectively manage their business. They were always willing to pay for them and they are continuing to do so now, in spite of the constant rumbling about CMS regulations. At the other end of the spectrum, the small providers, mainly physicians in private practice, who are more financially strapped than ever, see no good reason to take on debt and pay for tools with no demonstrated ability to provide tangible returns. Keep in mind that using paper-based tools to manage a few hundred customers who purchase one of a handful of services between 9 and 5 four days a week, is not nearly as onerous as managing millions of customers purchasing thousands of different services around the clock all day every day. Nevertheless, even these small providers are starting to buy EHRs. As EHR software gets better, some manage to find efficiencies never before contemplated and others are just trying to keep up with the Joneses and survive. Reluctantly and grudgingly, with lots of hard feelings building up, they too are willing to pay.

Patients – All stated goals of EHR adoption ultimately benefit patients. Some may stand to benefit more than others, but in aggregate we will all benefit from improved quality, reduction in disparities and cost containment of medical services. Whether directly or indirectly, through taxation, premiums, wage reduction, increased prices of goods and plain old cash, patients pay for the entire enormity we call health care costs, which includes cost of actual care delivery, overhead and profit margins for all other stakeholders. EHR software is part of that overhead and so are the costs of analyzing, displaying and exchanging information collected by EHR software. When CMS and private insurers and even health care providers write checks for EHR software vendors, somewhere down the line this translates into a little bit less health care for each patient and/or a little more money needed to obtain care. So although we pay for all EHR expenses, we as patients, find ourselves in the perplexing situation where we are forced to lobby, argue, advocate and practically beg for access to the work product of EHR software. And that work product is our life story. It is the record of our birth, the narrative of our childhood successes and mishaps, a document of our education, sexual activity, fears, hopes, marriages, new children, career choices, residence, divorce, widowhood, disease, death and everything in between. In other words: Data. We are paying for this data to be collected, exchanged and analyzed. We are paying for people to decide if we should have a right to opt-in or opt-out of such activities. We are paying for media campaigns to convince us that what we are already paying for is worthwhile.

So here is one suggestion: instead of paying for EHRs indirectly, while allowing all stakeholders to complain about the expenses as if the fees came out of their own pockets, how about patients paying for EHRs directly? There is no difference in aggregate and we are not talking about a lot of money for each individual patient. A yearly fee of something between $5 and $10 per patient, per facility, should suffice. Call it EHR fee, or EHR subscription. Once we explicitly pay for it, we own it; not the software, not the hardware, but the Data itself. And this is how it should be.

Sunday, September 25, 2011

Road Trip to Meaningful Use Land

The voice on the phone seemed genuinely amused, “Let me see, the GPS can’t find our location, right?” Right. One U-turn by the burnt barn, a right after the Conoco station, another right at the end of the road, a left across the John Deere and two and a half hours from the city on highway W, brought me to a small and very white store front, housing a nail salon and a busy family physician practice. If I stretched out both arms, I could put one hand on the front desk, and place the other hand on the back of a waiting room chair. There were six chairs separated by small tables adorned with yellow silk flowers. A texting young man in jeans and baseball cap and a middle aged woman clad in floral attire and a big green purse, occupied two of those chairs. And then Bessie walked out the doctor’s office behind the usual and customary tennis ball footed aluminum walker which was almost as tall as her, and helped by the front desk lady made a slow trek to the one chair with arms on both sides. They were calling Joe to come pick her up. Joe was going to be there in ten, fifteen minutes, tops. It was 4 PM and they were running behind.

Looks can be deceiving though. This practice is an anomaly in the rural health continuum. There are computers in every room and not even a trace of paper charts. They’ve been on a top of the line Cadillac EMR since 2005, paying a small fortune every year for the privilege and for IT guys to support it. They kept up with all the upgrades and are on the latest and greatest certified version and would very much like to get the Meaningful Use incentive that will cover about three quarters of what they spent on EMR maintenance this year. The doctor would even like to try the patient portal. He thinks it could make him more efficient. They were all ready to go on October 1st, but then something happened. They started getting solicitation emails from their EHR vendor informing the doctor that there are several accessories that he must purchase in addition to his fully certified EHR, if he wants to qualify for Meaningful Use incentives, and of course, the Cadillac vendor has a special sale on accessories this month. Confusion and frustration were palpable around the huge, and completely out of place, formal pedestal dining table in the break room.

I’ve been to this movie before, and I never had any luck convincing this particular vendor that a certified complete EHR should allow the user to achieve Meaningful Use with no need for other bits and pieces that were not mentioned anywhere during the certification process. Unfortunately, those who certify EHRs and those who supervise the certifiers are turning a blind eye and a deaf ear to what is essentially a regulatory issue. In the break room the confusion and frustration were slowly changing to anger and the big plastic QT cups of pink lemonade that were brought in by someone didn’t help much. The conversation shifted to the various Meaningful Use measures and by now I wasn’t surprised to hear that they are doing rather well on most, from electronically prescribing everything to recording race and ethnicity and generating beautiful CCD clinical summaries. They weren’t sure how to give folks electronic copies of their medical records, but nobody ever asked for that and it’s highly unlikely that anyone will in the next three months. That should be good enough.

“Am I also good on immunizations? I don’t do many of those either… maybe a few HPV and some flu shots for elderly patients to save them a trip to the pharmacy. I shouldn’t have to report anything, right?” Eh… wrong, doc. Even if you only do one immunization in the next three months, you would have to test an immunization interface with the State registry, and your Cadillac EHR can’t generate the test file at this time although it is fully certified for Meaningful Use. I’ve been trying to get an answer from this vendor for months. I’ve asked CMS for a solution over a month and a half ago. I have written a blog post that got more page visits than anything I ever wrote before, and came up empty on all fronts. But the doctor seemed to be working his way to an innovative solution all by himself.

“So if I don’t give any shots after October 1st, I should be OK…. We have one bottle of HPV left anyway and Marcie needs her shot… I have a week to do that… They pay peanuts for shots, you know…. They’ll just have to go to the pharmacy…. It’s not that far…. I really don’t give many shots anyway… Yep. It should work… “. October is flu season, and I was wondering if Joe picked up Bessie by now and if the pharmacy is on their way home. I wanted to know if the pharmacy had a chair with arms for Bessie and if the pharmacy folks would also call Joe to pick her up after waiting in line for her flu shot. But instead, I just found myself mumbling that this wasn’t really the intent, but yeah, this should work.

A couple of months ago, I heard a story about a geriatrician who chose to stop giving courtesy flu shots to his patients because of Meaningful Use. I found it hard to believe then. Needless to say, I believe it now. I am certain this was not the intent at CMS and I am pretty sure this was not on the Meaningful Use roadmap at ONC. I am not in the habit of pleading and begging the powers to be to do the right thing, but I will make an exception this once. This unremarkable little practice in the middle of nowhere could have been the poster child for successful EHR adoption. Can somebody at HHS, CMS or ONC help these small practices stand up to the greedy whims of a powerful EHR vendor? And above all, can we do something to help Bessie keep her “I” in Health IT, please?

Disclaimer: In order to protect their privacy, the names of all people and locations mentioned in this post have been changed, as have certain physical characteristics, quotations and other descriptive details.

Sunday, September 18, 2011

The Power of Empowerment

Grant Wood, American Gothic (1930)
Housing is expensive if you want to live in a Tudor style mansion on a half-acre wooded lot. Housing is a lot cheaper if you choose to rent a two-bedroom apartment on the fourth floor of a square building with no elevator, 45 minutes away from your workplace. And it won’t kill you to rent. Food is also very expensive if you want a varied, fresh and gourmet diet, but food can be cheap, and it won’t kill you to cook your own food and stick to a diet of mashed potatoes and boiled cabbage, with an occasional bit of tripe. Health insurance is very expensive if you insist on having all your medical needs covered by an insurance policy. Health insurance can be a lot cheaper if you pay for most of your medical care yourself and if you only buy limited coverage for the eventuality of falling off your dressage horse, and cheaper still if you promise to drop dead shortly thereafter.  Health care itself is very expensive if you insist on receiving medical care from highly trained professionals, using cutting edge technology in state of the art facilities. Health care can be a lot cheaper if you find a way to take care of your health without involving doctors and hospitals and their overpriced opinions, chemicals, machines and unnecessary procedures. It’s all about consumers empowered to freely make their own choices: mansion or rented apartment, steak or tripe, Cadillac or catastrophic health insurance, ICU or alcohol rub…..

The Consumer Empowerment terminology originated in the health insurance industry to mark the transition from having insurers pay for every cut, bruise and sniffle, to the more responsible way of paying for much of your health care directly out of your own pocket leaving the insurer responsible for rarely incurred catastrophic expenditures. The newly empowered consumers discovered that health insurance is now much more affordable, and perhaps even unnecessary, while health insurers discovered that magically, their profits are also improving, probably because empowered consumers seem to generate significantly less reimbursement claims, than the irresponsible and unempowered crowd served by public entitlements.

Although empowering consumers to pay for their own health care proved to be a stroke of genius, we have a long way to go before the overall cost of health care is contained. The problem here is that over the years Americans figured out that staying healthy doesn’t really pay off and quite the opposite is true, because once you get really sick there are all sorts of freebies made available to you, from amputations to chemotherapy to mastectomy to castration - a veritable smorgasbord to choose from, and the temptation is huge since the monetary value of these free goodies can add up to more than many people make in a lifetime of hard work. Not to mention the fatherly physician figures busy offering you helping after helping of a carefully selected array of the most expensive fare available. And then an innovative idea was put forward by selfless luminaries, and is catching on like brushfire after a long global warming induced drought. If health care insurers were able to cut costs and increase profit by empowering consumers to insure themselves, could health care providers achieve the same spectacular success by empowering consumers to care for themselves?

Empowering consumers to engage in their own health care may rank up there with cold fusion and perpetuum mobile in its transformational potential for humanity. Empowering millions of people to actively manage their medical care, by making their own medical decisions, breaking free of the old-fashioned paternalistic directives of financially conflicted physicians, and restoring the nineteenth century self-reliant approach to health care, will slash costs, improve quality and eliminate disparities in health and health care in one patient-centered fell swoop. And how do we accomplish such monumental task? We harness the unlimited power of the Internet. This is the Information age, and just like the Industrial age brought a car and a television set to every home, the Internet puts the entire world’s knowledge at the fingertips of all humanity with astounding effects already visible in the education attainment of our children. But the world’s knowledge is missing a vital piece of information pertinent to our goals in health care.

Enter Health Information Technology (HIT). HIT will pry loose the last piece of the puzzle – the secretive documentation amassed and jealously guarded by doctors in their offices. Information kept in detailed color coded charts and recorded in strange cult-like symbols that prevent anybody but doctors from understanding the contents. Once that information is made available to computers and the thousands of new high tech tools chomping at the bit to translate, analyze and recommend what you should buy to treat any ailment ever recorded, the Internet will bring this knowledge to every hamlet and fuel a renaissance of rugged Americanism where every man woman and child will be empowered to manage his or her own health care. The amount of money spent on health care will decrease sharply since the time people spend researching, diagnosing and treating themselves at home, and the cost of technology tools and over the counter remedies to facilitate these activities are not considered health care expenses. The quality of such care will be exponentially improved by harnessing the knowledge and insights of millions, instead of just one medical school graduate. And by definition, the Internet eliminates all disparities, as evidenced by the blossoming democracy in Egypt.

So much empowerment may seem a bit daunting to some who grew accustomed to getting advice from doctors. No need to worry though because this will be a gradual and gentle process. It’s not like you will have to perform an appendectomy on yourself come Monday morning, although it wouldn’t hurt to start practicing simple things like freezing warts at home and researching minor chest pain on Internet boards. When you finally keel over in pain, or are otherwise ready to confront a doctor, you must prepare yourself mentally to act as empowered as possible. While the civic minded insurers have been happy to empower people and let them spend their own money any way they saw fit, doctors find it much harder to relinquish control of their patients. You need to come in with all your symptoms researched, a tentative diagnosis formulated and most important, a preferred course of treatment that fits your cultural values and preferences. You need to resist your doctor’s efforts to tempt you into partaking in the smorgasbord of free tests and procedures, some of which will be harmful to you and others will be very unpleasant for your friendly insurer. If you concur with your doctor’s opinion and have some tests done, make sure you understand WBCs and RBCs, units and normal ranges for the lab you are going to use after shopping around for a good price, and be sure to validate whether you need a differential count or not. The Internet is your friend and all this information is available online. But whatever you do, don’t leave your doctor’s office without an electronic copy of your medical records in a computable format, because any day now, there will be a free app for all these decisions and iWatson will empower you to care for yourself and your loved ones in ways that the log-cabin pioneers couldn’t even dream about. Better, faster and infinitely cheaper.

Tuesday, August 23, 2011

CMS Owes an Apology to Meaningful Users

According to the July 2011 data from CMS there are over 75,000 clinicians currently registered for the various Medicare and Medicaid Meaningful Use incentive programs. A tiny fraction of these, 2246 to be exact, has successfully attested to meeting all Meaningful Use criteria (or claimed allowed exclusions), and about half have gotten the much coveted incentive checks. Considering that these figures include Nurse Practitioners, Dentists and Optometrists, it seems that the physicians that expressed interest in the incentives by registering with CMS are the same 6.9% that were identified by CDC in 2010 as using fully functional EHRs back in 2009. Even if we assume that the second half of 2011 will bring a surge in attestations to meaningful use of certified EHRs, it is still unlikely that a majority of those registered will go through attestation.

There are three broad reasons for these low numbers. First, there are those working their way through the 90 days attestation period as we speak, or are planning to start any day now. These folks have their ducks in a row and will attest in 2011. Second, there is a group that went ahead and registered with CMS “just in case”, but made no commitment to investing the energy and time needed to fulfill Meaningful Use requirements. These physicians are still debating whether they should upgrade their EHRs to a certified version, or if they already have a certified EHR, whether they are ready to begin documenting all the additional information in the specified formats as required for attestation. With less than 6 weeks left before the absolute last day for starting to measure, there is practically no chance that this group will be able to attest this year, and many registered with a clear intent to postpone Meaningful Use to 2012 anyway. Third, there is a significant number of doctors whose plans and efforts are being frustrated by shortcomings of EHRs and EHR vendors. This last group warrants a closer look.

Judging by press releases and earning reports from publicly traded EHR vendor companies, business is booming and EHRs are selling like hot cakes. The flip side, of course, is that waiting times for software installation are steadily increasing for both new purchases and upgrades. Since ONC certification bodies have no requirements stating that the certified software should be in actual use by customers, many vendors were able to certify EHR versions that were not ready for general deployment. Some vendors deemed it necessary to charge significant fees for functionality required for Meaningful Use in addition to the ongoing maintenance fees which should have entitled their existing customers to a free upgrade to the certified version. Adding it all up results in many unhappy customers having to wait in long lines for something that should have been forthcoming, and having to spend large sums of money on something that should have been free. And when they finally reach the front of the line and pony up the various extortion fees, they may still end up right back where they started.

Over a year ago, on this blog, I posed a very simple question: “Can you buy an ONC Certified EHR, or a package of EHR modules, and discover to your chagrin that no matter how hard you try, Meaningful Use is not within reach?” After a close look at the certification criteria for EHR software, my conclusion was that “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.” Of course physicians did not understand and ONC did not clarify and here we are today fully engaged in damage control. The problems range from rampant software defects to impossible workflows to plain missing functionality. How is that possible?

If you ever dabbled in software development, you should know that successfully testing a few predetermined isolated function points in a large software package is never an indication that the software works as designed. To use our beloved car analogy, starting the car once, turning the lights on once and activating the wipers once provides no solid indication that the car is not going to explode after two minutes on the highway, let alone that both wipers and lights will keep on working as you proceed out of the dealer parking lot. Now imagine that the car seller is allowed to performs all these tests while you are standing aside, observing the final result only. So a hotwire instead of an ignition key, a string attached to the wrist to pull the wipers back and forth, and a bunch of little flashlights instead of brake lights are all possible. That’s the essence of Meaningful Use EHR certification testing. Sometimes you get lucky and sometimes the thing you just bought smokes, and barely limps along sputtering motor oil and antifreeze.

But nothing is more misguided and inappropriately tested as the various requirements for interoperability. There are several Meaningful Use measures requiring that the EHR has the capability of exchanging information with other facilities, and that the user performs just one test of that capability to qualify for incentives, and the test does not even have to be successful. Sounds easy when you sit in a conference room overlooking blossoming cherry trees on the Potomac. Returning to cars, imagine that the requirement is that the vehicle is able to tow another car, or a U-Haul little trailer, or a boat. During certification, the vehicle presents with a lovely towing package installed; the tester attaches a cardboard car model to it and the entire assembly is shown to be able to advance one inch from where it was originally located. Hence, the vehicle is now certified for towing cars. The first thing you discover after you purchase the certified vehicle is that the various towing packages don’t come standard with the car. You will have to pay for each one and pay to have it installed. To add insult to injury, the towing packages have only been tested with cardboard models and there is much work to be done before they can be tested with real boats, cars and trailers. And there are several hundred customers in line ahead of you. Perhaps you should call again in a few months, or better yet don’t call us; we’ll call you.

To qualify for Meaningful Use incentives a physician must perform at least one test of submitting either public health data or immunizations data to a public agency. Exclusions apply to those who do not administer immunizations and to those who practice in a State where there is no public agency capable of accepting such data. There are less than a dozen agencies where one could submit public health data, but many more immunizations registries up and running. A typical very large EHR vendor will have operational interfaces to less than a handful of immunization registries that are readily available for purchase, usually in States where health information exchange is very advanced. Everywhere else money can’t buy you an immunization interface. It can buy you a place in line, if the vendor is working on an interface with your State registry. Otherwise a rain check is the most you should expect.

There is no way physicians could have anticipated this problem when they purchased a fully Certified EHR. There is nothing physicians can do now, or could have done earlier, to address this problem. And there is no way for EHR vendors to create over 50 working interfaces to State registries and deploy thousands of those interfaces to their customers before the clock runs out on 2011 reporting periods. By ignoring the reality on the ground, CMS erred in its requirement and ONC erred in its certification process. The only thing left to do now is for CMS to officially allow exclusion of public health measures across the board. An apology wouldn’t hurt either….