Three days of PPACA Orals

“A third of this country thinks health care is a basic human right and the government should finance the whole shebang; another third thinks health care is a market good that should be earned, with the government banished from sight; a middle third does not know what it thinks, only what it fears, based on the latest anecdote about Medicare fraud, insurance company abuse, government incompetence, or medical private profiteering in their local news cycle.  If nothing else, ObamaCare has proven to be a dark mirror on our most deeply embedded cultural conflicts, from the death panel freakshows to the neanderthal discussion on birth control.” 

- JD Kleinke 

"It’s always a bit strange to hear people with government-funded single-payer health plans describe the need for other Americans to be free from health insurance. But after the aggressive battery of questions from the court’s conservatives this morning, it’s clear that we can only be truly free when the young are released from the obligation to subsidize the old and the ailing." 

- Dahlia Lithwick

WEDNESDAY UPDATE

Three days of argument, six hours total, 427 pages of transcript spanning four areas of contention: AIA "Ripeness," Individual Mandate, Severability, and Medicaid "coercive" expansion.

Lotta stuff goes down with the ship should they strike PPACA in toto. e.g., just the section pertaining to much of my work going forward.

In addition to much more. Dunno; maybe a lot of this stuff is indeed a waste (as critics have said of ARRA/HITECH as well). But, do we seriously believe that competing for-profit entities will rush to fill the breach to do a transformative collective altruistic Kumbaya for the benefit of the commonwealth?

"At the end of the day, it is a very hard thing to ask the federal court to strike down any act of Congress, particularly one like this that has the eyes of so many Americans on it. One thing here is that a lot of the concerns are policy concerns against the act and not constitutional concerns. In circumstances like this, in which there is no clear constitutional law that blocks the government from doing what it is doing, it is going to be very difficult to strike it down." 

- Neal Katyal, Georgetown law professor and former acting solicitor general, May 2010-June 2011

REWIND: "One thing here is that a lot of the concerns are policy concerns against the act and not constitutional concerns"

Indeed. e.g., from HealthCare.Gov:

Title III. Improving the Quality and Efficiency of Health Care

The Act will protect and preserve Medicare as a commitment to America’s seniors. It will save thousands of dollars in drug costs for Medicare beneficiaries by closing the coverage gap called the “donut hole.” Doctors, nurses and hospitals will be incentivized to improve care and reduce unnecessary errors that harm patients. And beneficiaries in rural America will benefit as the Act enhances access to health care services in underserved areas. 

The Act takes important steps to make sure that we can keep the commitment of Medicare for the next generation of seniors by ending massive overpayments to insurance companies that cost American taxpayers tens of billions of dollars per year. As the numbers of Americans without insurance falls, the Act saves taxpayer dollars by keeping people healthier before they join the program and reducing Medicare’s need to pay hospitals to care for the uninsured. And to make sure that the quality of care for seniors drives all of our decisions, a group of doctors and health care experts, not Members of Congress, will be tasked with coming up with their best ideas to improve quality and reduce costs for Medicare beneficiaries.

The Secretary has the authority to take steps to strengthen the Medicare program and implement reforms to improve the quality and efficiency of health care.

Title IV. Prevention of Chronic Disease and Improving Public Health

The Act will promote prevention, wellness, and the public health and provides an unprecedented funding commitment to these areas. It directs the creation of a national prevention and health promotion strategy that incorporates the most effective and achievable methods to improve the health status of Americans and reduce the incidence of preventable illness and disability in the United States.

The Act empowers families by giving them tools to find the best science-based nutrition information, and it makes prevention and screenings a priority by waiving co-payments for America’s seniors on Medicare.

The Secretary has the authority to coordinate with other Departments, develop and implement a prevention and health promotion strategy, and work to ensure more Americans have access to critical preventive health services.

Title V. Health Care Workforce

The Act funds scholarships and loan repayment programs to increase the number of primary care physicians, nurses, physician assistants, mental health providers, and dentists in the areas of the country that need them most. With a comprehensive approach focusing on retention and enhanced educational opportunities, the Act combats the critical nursing shortage. And through new incentives and recruitment, the Act increases the supply of public health professionals so that the United States is prepared for health emergencies.

The Act provides state and local governments flexibility and resources to develop health workforce recruitment strategies.  And it helps to expand critical and timely access to care by funding the expansion, construction, and operation of community health centers throughout the United States.

The Secretary has the authority to take action to strengthen many existing programs that help support the primary care workforce.

Title VI. Transparency and Program Integrity

The Act helps patients take more control of their health care decisions by providing more information to help them make decisions that work for them. And it strengthens the doctor-patient relationship by providing doctors access to cutting edge medical research to help them and their patients make the decisions that work best for them.

It brings greater transparency to nursing homes to help families find the right place for their loved ones and enhances training for nursing home staff so that the quality of care continuously improves. The Act promotes nursing home safety by encouraging self corrections of errors, requiring background checks for employees who provide direct care and by encouraging innovative programs that prevent and eliminate elder abuse.

Finally, the Act reins in waste, fraud and abuse by imposing tough new disclosure requirements to identify high-risk providers who have defrauded the American taxpayer. It gives states new authority to prevent providers who have been penalized in one state from setting up in another. And it gives states flexibility to propose and test tort reforms that address several criteria, including reducing health care errors, enhancing patient safety, encouraging efficient resolution of disputes, and improving access to liability insurance.

The Secretary has new and improved authority to promote transparency and ensure that every dollar in the Act and in existing programs is spent wisely and well.

Title VII. Improving Access to Innovative Medical Therapies

The Act promotes innovation and saves consumers money. It extends drug discounts to hospitals and communities that serve low-income patients. And it creates a pathway for the creation of generic versions of biological drugs so that doctors and patients have access to effective and lower cost alternatives.

The Secretary of Health and Human Services has the authority to implement these provisions to help make medications more affordable.

Title X. Reauthorization of the Indian Health Care Improvement Act

The Act reauthorizes the Indian Health Care Improvement Act (ICHIA) which provides health care services to American Indians and Alaskan Natives. It will modernize the Indian health care system and improve health care for 1.9 million American Indians and Alaska Natives.

The Secretary, in consultation with the Indian Health Service, has the authority to implement the Indian Health Care Improvement Act.

Now, maybe one can legitimately be dubious with respect to the wisdom/prospective utility of one or more of these ostensibly noble provisions. It escapes me, however, how they could be found to be "unconstitutional," -- beyond the scope of legitimate Congressional authority.

If the decisions of individuals not to eat broccoli and not to buy burial insurance had similar effects on interstate commerce, then it might also be appropriate for the national government to intervene. But the hypotheticals are, quite frankly, ridiculous. They are bad arguments to which any first-year law student knows the answer. If the conservative justices, who are, after all, very good lawyers, rely on such arguments to defend a decision to invalidate the Affordable Care Act, then we know something else is going on.

How justices who purport to celebrate their commitment to judicial restraint and judicial modesty could even imagine striking down this law on such transparently weak grounds is beyond comprehension. For that reason, I don’t believe they will do so. If they do, it will be (another) dark day for the Supreme Court, which already labors under a cloud of public disillusionment after its decisions in Bush v. Gore and Citizens United.

- Geoffrey R. Stone, Esq, Edward H. Levi Distinguished Service Professor of Law, University of Chicago.

The Health Care Blog posted a nice compendium of the dueling rhetorical analogies at Orals.

1. Is mandating health insurance like mandating that people buy cell phones to call 911? (Chief Justice Roberts).
2. Is the mandate like a requirement that we buy insurance to pay for our own burial services? (A macabre Justice Alito, who’s right: we’re all going to die).
3. Is the mandate like forcing us to buy broccoli? (Justice Scalia, invoking the dreaded broccoli analogy, which is apparently one of the parade of horribles that logically flows from the health insurance mandate, a canard that David Orentlicher has exposed).
4. Is it like forcing us to buy cars? (Chief Justice Roberts and later, Justice Scalia, referring to the government’s reply brief, which tried to distinguish a federal mandate that we buy U.S. automobiles from the insurance mandate).
5. Is it like imposing a duty to rescue strangers in trouble, like a “blind man walking in front of a car”? (Justice Kennedy).
6. Is it like setting phone rates to require that some callers subsidize others? (Solicitor General Don Verrilli).
7. Is it like requiring everyone to join an exercise club? (Justice Scalia).
8. Is it like mandatory inoculation during a pandemic? (Justice Breyer, perhaps inspired by the movie Contagion).
9. Is it like forcing people to deposit all their money in the Bank of the United States? (Justice Breyer’s colloquy with Paul Clement, counsel for the state plaintiffs, invoking McCulloch v. Maryland).
10. Would it be like the federal government requiring us to buy car insurance if states didn’t already do so? (Justice Sotomayor, to whom Paul Clement responds that there are lots of people in Manhattan that don’t drive cars. True, but we all have bodies, which require regular tune-ups and sometimes major repairs).
11. Would it be like Congress forcing everyone to buy “a great new wonder drug”? (Paul Clement).
12. Is it like growing wheat (Wickard v. Fillburn), or weed (Raich), or carrying guns near schools (Lopez), or committing violence against women (Morrison)? Note that these are the four most direct Commerce Clause precedents, which get comparatively buried during oral argument, amid all the analogy-searching.
13. Is it like Congress requiring everyone to buy an electric car? (Paul Clement, who is hitting his stride by this point).
14. Is it like requiring us to buy anti-pollution devices or low-emission mufflers for our cars? (Justice Breyer, who is not).
15. Is it like requiring that everyone buy private mortgage insurance? (Michael Carvin, counsel for the private plaintiffs).
16. Is it like requiring some pesticides rather than others in food? (Justice Sotomayor).
17. Is the decision not to purchase health insurance like local manufacturing, which is regulated federally because some products might, eventually enter interstate commerce? (Justice Sotomayor).

I also enjoyed the arduous nit-picking over the framing semantics of key words and phrases.

"In the animal kingdom, the rule is, eat or be eaten; in the human kingdom, define or be defined."

- Thomas Szasz, MD

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"There's an Alice-In-Wonderland aspect to this debate since the politics of the individual mandate intimately intersect with the political careers of this year's presidential nominees. One candidate even pretends his pioneering role is somehow irrelevant because of the 10th Amendment or some other rhetorical sleight of hand. 

Supreme Court justices are political animals and they're more than willing to take precedents and cast them overboard if it furthers their own activist desires (e.g., Citizens United). If this case were decided purely on the basis of stare decisis, there would be no question about the legality of the mandate. But it's being decided in a political arena, one where the actors wear black robes and over their campaign buttons. 

The ideological question that is the central to our government is whether the Constitution should reflect the country of the 21st century or the 18th century. Thomas and Scalia are more than willing to turn back the clock to an agrarian republic where simplicity ruled the lives of citizens. Today, it's complexity that rules, mostly because of industrialization and economic stratification, and as a result of that, a citizenry ruled by economic forces the Founding Fathers couldn't foresee. A Constitution that doesn't reflect the physical reality of this republic is a straitjacket. And a jurisprudence that indulges nostalgic daydreams of yeoman farmers and town halls is probably closer to nihilism than virtue."

- Walter Hall

If that doesn't suffice, consider "ObamaCare Is On Trial. So Is the Supreme Court" by Jonathan Cohn:

...Virtually everybody agrees that a vote to strike down the Affordable Care Act would be five to four—a bare majority. And it would be a bare partisan majority, with the five Republican appointees overruling the four Democratic appointees. The decision would appear nakedly partisan and utterly devoid of principle. Appearances would not be deceiving.

The second distinction is even more more significant. Today Brown is a nearly universal icon of social progress, while Roe remains an object of great controversy. But, for better or for worse, both cases represented efforts to change the everyday reality of American life. With Brown, the justices were tearing down barriers to racial equality; with Roe, the justices were eliminating laws that prevented access to abortion.

But in this case, nobody has said they want to stop government from providing universal access to health care. On the contrary, the plaintiffs have stated that a program like Medicare, in which the government provides citizens with insurance directly, would be clearly constitutional. They’ve also stated that a scheme of compulsory private insurance would be constitutional if somehow the government could make people buy it when they show up at the hospital—suggesting, as Elena Kagan stated, that the only problem with the Affordable Care Act is temporal. 

Most amazing of all: The plaintiffs have conceded that a universal health insurance program would be constitutional if, instead of penalizing people who decline to get insurance, the government enacted a tax and refunded the money to people who had insurance. As Sonia Sotomayor noted, functionally such a scheme would be exactly the same as the Affordable Care Act. Both the plaintiffs and some of the skeptical justices have also indicated that the Affordable Care Act would be constitutional if the law's architects had simply used the word "tax" to describe the penalty.

Think about that for a second: If the justices strike down the Affordable Care Act, they would be stopping the federal government from pursuing a perfectly constitutional goal via a perfectly constitutional scheme just because Congress and the Preisdent didn’t use perfectly constitutional language to describe it. Maybe labels matter, although case law suggests otherwise. But do they matter enough for the Court to throw out a law that will provide insurance to 30 million people, shore up insurance for many more, and help to manage one-sixth of the American economy? It wouldn’t seem so.

Of course, the conservative justices who would invalidate the Affordable Care Act may not hold the law in especially high regard. Samuel Alito, in particular, suggested during oral argument that he had serious problems with younger, healthier people subsidizing, via their insurance premiums, the medical expenses of older, sicker people—which just happens to be the defining feature of Medicare, Social Security, and every other social insurance scheme on the planet.

Alito is entitled to his opinion about what makes for good legislation. But he’s not entitled to impose that opinion on the country and his colleagues aren’t, either. Their job is to determine whether a law is constitutional, not whether a law is wise. And the more significant the law, the more unambiguous their judgment ought to be.

Indeed, indeed.

One way or another, we'll know in about three months. So, what to do while we wait? How about Joe Flower's comment in “Three Strategies for the Health Care Industry While Reform’s in Limbo”:

The whole debate over the PPACA has obscured the fact that there is a massive shift in the economic structure of healthcare that we are seeing the beginnings of, and that will accelerate over the next few years, and that will likely change the way we do business in this field massively, leading, I believe, to much cheaper healthcare done much better for many more people. Those parts of the PPACA you refer to are small catalysts of some of this change, but are not the change itself.

ACOs themselves, in most of the forms we are seeing, are not actually business models. In ACOs the government is saying, in effect, “find ways to cut your own revenue stream, follow a lot of restrictions and procedures perfectly, and we will let you keep some portion of the money you saved us.” That’s not a sustaining economic model. Other models, like the Alternative Quality Contracts of the Massachusetts Blues, actually are a business model — organizations under them make money by saving the system money. This is a crucial difference. If you can base your business on making money by saving the system greater amounts, you have a sustainable business model that drives the system toward leaner, more effective territory very quickly.

So I would say to healthcare execs: Don’t pay too much attention to what happens to reform. Plan your strategy right now to leapfrog beyond it to completely new business models, before your rivals do, and before new organizations are formed to take the opportunity away from you.

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BACK TO "MY SCOPE"

Just downloaded this to my Kindle. Looks very interesting. to wit, at random:

0: Health IT Humility

The first thing that computer technologists must free themselves from is the notion that computers are the “solution” to information flow in a clinical environment. If computer specialists do not understand everything that a paper process is doing, or fail to respect the ways in which a paper-based information system handles something well, then they will appear arrogant to the clinical staff, who understand perfectly how effective the paper forms can be. When you introduce a computer system that makes a process that used to take 30 seconds take 10 minutes, then your solution will instantly be met with derision by clinical staff who are already overworked. 

If you want a concrete example of how good paper is, consider the surgical checklist movement that has been growing in popularity. Studies have shown that this simple information intervention, which uses either a paper form or a whiteboard, has improved patient safety on the operating table more than any surgical technique advancement in the equivalent time frame. The next time you are feeling smug about your awesome health IT plans, keep in mind that this simple information intervention, which required no software at all, might be the most effective information-based intervention of the decade.

Trotter, Fred; Uhlman, David (2011-10-07). Meaningful Use and Beyond: A Guide for IT Staff in Health Care (Kindle Locations 1544-1554). OReilly Media - A. Kindle Edition. 

Chapter 10   

Ontologies: 

Practically speaking, an ontology is just a fancy word for a dictionary. More specifically, an ontology is a way of structuring knowledge, by coding complex concepts into simpler terms. Beyond that, ontologies vary widely in the level of complexity given to structuring the relationships between the terms. Some people use the term ontology in healthcare to refer to only systems that are capable of deeply modeling clinical information. Others use the term to refer generally to all types of abstract health care data sets. Sometimes, people speak about ontologies in terms of codes, code sets, or coding processes. This chapter will cover both important sources of clinical coding systems or ontologies, of several types.  

The basic problem that clinical ontologies seek to address is the difficulty that automated processes have with synonyms. Heart attack, cardiac arrest, and myocardial infarction, as well as the acronyms MI or AMI, can all be used to describe the same event. Having multiple terms for the same thing is difficult if you want to fully automate any clinical information process. An ontology solves this problem by noting that the terms heart attack, myocardial infarction, MI, and AMI really are the same thing, and cardiac arrest, like cardiac arrhythmia are related terms, but not synonyms for those concepts.  

Traditionally the academic study of ontologies has been of interest to philosophers, computer scientists, and cognitive scientists, who are deeply concerned with the mechanisms by which humans encode knowledge. We will mostly be ignoring the high-brow, but interesting, philosophical issues with ontology unless they specifically impact some aspect of the practical use of ontologies in healthcare. If you are already familiar with the concepts of ontologies you might be somewhat offended by the way typical medical ontologies ignore simple obvious principles that the science of ontology provides. Most medical ontologies are either irredeemably poor as knowledge representation schemes, or so consistently abused in practice that they might as well be. Moreover, no chapter on medical ontologies could begin without the admission that the coverage of ontologies is complex enough to merit a book on its own, and that the licensing of medical ontologies is so convoluted and inconsistent that this chapter certainly should not be taken as anything close to legal advice. 

(Kindle Locations 3784-3804).

Chapter 4: The Bandwidth of Paper 

...Consider the blank sheet of plain white paper. A sheet of paper can become legal notes for a lawyer, the design of a machine or circuit for an engineer, the careful drawing of a building for an architect, and notes about a patient for a doctor. When you account for paper airplanes and origami, paper has a wonderfully large number of wonderful uses. 

The powerful aspect of a paper chart is that there is never a limitation of the type or content of data that can be added. If it can be written or drawn, it can be added as needed. 

The recently released Apple Retina display is 326 pixels per inch (PPI), and normal humans cannot see clearly past 300 PPI. In the HDMI video standard, monitors must support 30-bit color on the low end. An 8-1/ 2 x 11-inch sheet of paper comes out to 8,415,000 pixels at 300 DPI (more HD than the most uber-HD monitors now available). 

Assuming they support a 30-bit color depth, this means that they are supporting 252,450,000 bits per image, or about 31 MB per image. Of course, the human eye is capable of seeing many of these pages per second, but the real of the paper system is a human’s ability to change sheets of paper quickly. Assuming the doctor was really moving, he might see 5 pages per second. That puts the bandwidth of paper at something like 1262.25 megabits per second (Mbps). In comparison, a good broadband Internet connection runs at about 5 Mbps, which is enough to stream movies. If you account for the fact that a doctor might be dynamically ignoring 995 pages of medical record to look at the right 5 pages, and then considered her rate of consumption at 1,000 pages per second, the bandwidth of paper is faster, by far, than any computer network in practical existence. All of these numbers are estimates, but it would be difficult for anyone not to concede that the actual bandwidth of paper-to-brain is pretty fast. 

Moreover, it is easy to make paper better at any given information task. It is simple for any doctor to use a computer or photocopier to print lines and labels all over the blank sheet of paper, turning a simple sheet of paper into a form. Paper forms in healthcare are far more potent than in most industries.  

When doctors look at a paper form, they feel no loyalty to the lines and check boxes. Doctors are not mere paper pushers or automatons who fill in everything in triplicate. Doctors feel comfortable drawing “outside the lines” and because they often create their own forms, and are frequently the only readers of their own completed forms, the paper-based patient data system melds easily with the mind of the designing physician. This is all just the benefits of a single paper form; when you add a folder to keep groups of forms together, it becomes even more powerful.  

Instructions, diagrams, complaints, compliments, questions, answers, tables, pictures, reports, receipts, faxes, and, of course, post-it notes can all be added to a paper chart, normally just a folder, with ease. Doctors’ handwriting is famously illegible, but they rarely need to actually read the entire contents of a chart. They need to be able to use the written record of what they wrote to jog their memory: what is special or different about this patient, what are the next steps in the treatment? During typical operations the chart need only indicate what the next step is to the doctor who made it. But it is still powerful enough to hold the entire history (assuming the handwriting problem is addressed), for the rare occasions when it is important to look at everything.  

The nurse who filled out the example form in Figure 4-1 also wrote “Lung DZ” in the history section. That phrase means “Lung Disease,” and is a wonderful example of medical abbreviations, an important part of the paper chart that will make the jump to electronic charts. Medical abbreviations are now largely standardized, after a substantial number of medical errors occurred because of nonstandard abbreviations. The standardization of abbreviations bounds written data, even on paper forms. Once medical abbreviations became standardized, they provided a clear enough shorthand for common medical terms that they could safely be recommended for use. But this is only possible when the mapping between abbreviations and longer terms is perfectly understood and mostly identical everywhere. That mapping, between abbreviations and longer terms, is in fact a healthcare ontology, one that performs well on paper. We will discuss medical abbreviations further in Chapter 10.  

Workflow Tokens

Individual paper forms are typically tokens in a complex clinical workflow. The nurse fills out a form when the patient arrives and gives the patient a copy. The patient then takes it to the X-ray department. The X-ray department performs an X-ray and gives the results (on paper and film) to the patient to take upstairs to a particular doctor. The nurse in the waiting room takes the papers and film, and deposits them in a wall-mounted box outside an exam room, and escorts the patient into the room. Each of the steps can have a check box on the form itself, so that the patient knows just where to go next, and if she gets lost (and who doesn’t in a hospital?) anyone can look at the form and show the patient where to go next. There are thousands of variations on this basic theme to accommodate the various needs of different clinical organizations.  

This is an important insight that merits highlighting: even the paper chart (i.e., the bundle, not just a single form) is not just a paper record of a patient’s healthcare history and current status. It is also a token in a clinical workflow. Considering the record without considering the workflow is a simple mistake that is easy for technologists to repeatedly make. To prevent this mental error, try to adjust your mental imagery of a paper chart into something dynamic and moveable in nature. One of the authors tries to imagine the record as a manila folder with little wheels attached to it. That is a pretty silly mnemonic, but it works. 

Some clinics use colored folders to enable different workflows. They place the chart in a green folder and send the patient to the green waiting room. A red folder might mean that a patient is waiting in the red waiting room, and in another clinic it might mean that a patient needs to have blood drawn. As we say elsewhere, there is no such thing as a typical healthcare workflow. At a minimum the paper chart is the home base to the various paper forms that enable different clinical workflows, and the whole contents must be copied to other organizations or departments when the patient moves. So the paper chart is always a workflow token, exercised to different degrees, in different organizations. 

Often, a paper form will have been designed and cemented in the workflow so long ago that no current employee can remember why the form was designed in a particular way. Be very careful of this, because as you seek to replace the form in the workflow with software, you might discover that what you considered an incidental aspect of the form’s design was actually solving some important important problem in another portion of the workflow that you did not fully understand. 

Why Leave Paper?

Paper is an excellent record of clinical care, to the degree that the data does [sic] not need to move. It is a perfect healthcare record to the degree that healthcare is provided by a single clinician, looking at a patient chart and the patient all at the same time. Modern healthcare is no longer a one-doctor, one-record, one-patient game. The coordination of care for a patient requires that critical information be moved from where it is to where it needs to be, on time. Sometimes the paper chart moves fast enough. Most of the time it does not. God forbid a paper chart should be lost.  

The first thing that people assume when you say “coordination of care” is that you mean between-organization coordination. But the primary benefit of EHR systems is that they coordinate care within a healthcare organization. This is why EHR adoption has been so strongly correlated with the size of a clinical organization. The more an organization needs to communicate with itself about a given patient, the greater the benefit of an EHR system. Conversely, single-clinician practices get the least benefit from computerization.  

There are classes of medical errors that are clearly related to the information not moving fast enough, like a patient’s allergies or current medication list not being with the nurse when a new drug is given to a patient. Many preventable medical errors go away entirely when you measure them, which means they mostly disappear whenever manual observation occurs. The spread of infections due to clinicians forgetting to wash their hands is a good example of this. The only real solution is to measure these types of behaviors all the time electronically, preferably preventing rather than merely chronicling the errors in question. Real-time workflow interruption can only occur when data values can spawn real-world stimuli (like flashing lights or beeps), and that means software.
Lastly, paper charts are difficult to study en masse. Doctors can easily look at a single paper chart and see how a patient with diabetes is doing, but they cannot get same information about all of their patients with diabetes without doing costly and slow chart reviews. Paper chart reviews simply cannot serve to inform a profession that changes as fast as healthcare does.  

Paper data is [sic] trapped, inactive, and difficult to study. If paper could shout, there would be no need for EHR systems. (Kindle Locations 1446 -1542)

A good read thus far. Good coverage of the topics.

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More to come...

The Jennings Moot Court tees up the PPACA

From the Constitutional Accountability Center:

IDEOLOGICALLY DIVERSE MOOT COURT PANEL VOTES 8-1 THAT ACA INDIVIDUAL MANDATE IS CONSTITUTIONAL

Brooke C. Obie
March 22, 2012

As the Supreme Court gears up to hear oral arguments in the Affordable Care Act cases next week, the Peter Jennings Project for Journalists and the Constitution tested the central issue of the Act at its Sixth Annual Moot Court Program on March 20.  During the simulated court proceedings, a panel of distinguished law professors, noted legal thinkers, and current and former federal judges -- including four Bush (41 and 43) appointees and CAC Board member and former DC Circuit Judge Patricia Wald  -- heard oral arguments on the constitutionality of the minimum coverage provision in the ACA and voted 8-1 that the ACA’s mandate that Americans obtain insurance coverage or face a tax penalty is within Congress’s constitutional power to regulate interstate commerce.  

You can watch the webcast of this terrific moot court program below:

A Moot Court: Health Care on Trial from National Constitution Center on FORA.tv

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I watched all 2 hours and 2 minutes. Riveting. Cheryl and I know an attorney who once argued at Orals before SCOTUS twenty-some years ago (a disability case). The constant interruptions and vigorous pushback from the Justices in this video square precisely with her recounting of her experience.


I wish FORA.tv would publish a verbatim transcript of this event. There are for me some striking seminal moments a bit over an hour in that I'd love to cite. This stuff is the antidote to people like this:

Yeah, my friend, real "governance" and evidentiary due process are a pain.

I will be listening closely to each day's Orals audio release. A significant part of our work going forward is joined at the hip with a number of PPACA subtitles, so it's worth keeping tabs on this.
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From

 

"...Those Americans who die or go broke because they happened to get sick represent a fundamental moral decision our country has made. Despite all the rights and privileges and entitlements that Americans enjoy today, we have never decided to provide medical care for everybody who needs it.The far-reaching health care reform that Congress passed in 2010 is designed to increase coverage substantially—but it will still leave about 23 million Americans uninsured. Even when “Obamacare” takes full effect, the American health care system will still lead to large numbers of avoidable deaths and bankruptcies among our fellow citizens. As we saw in the national debate over that bill, efforts to increase coverage tend to be derailed by arguments about “big government” or “free enterprise” or “socialism”—and the essential moral question gets lost in the shouting. All the other developed countries on earth have made a different moral decision. 

All the other countries like us—that is, wealthy, technologically advanced, industrialized democracies—guarantee medical care to anyone who gets sick. Countries that are just as committed as we are to equal opportunity, individual liberty, and the free market have concluded that everybody has a right to health care—and they provide it. One result is that most rich countries have better national health statistics—longer life expectancy, lower infant mortality, better recovery rates from major diseases—than the United States does.Yet all the other rich countries spend far less on health care than the United States does..."

Reid, T. R. (2010-08-31). The Healing of America: A Global Quest for Better, Cheaper, and Fairer Health Care (Kindle Locations 62-73). Penguin Group. Kindle Edition.

New in my Kindle. Saw this referenced on Fareed Zakaria's new CNN "GPS Global" on the subject of health care reform (still trying to find a direct video embed link).

I know; this is "exceeding your scope." -- Just get EPs to MU.

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More to come...

PPACA Orals at SCOTUS, March 26-28

The complete docket items, including amicus briefs are linked here.

A huge three days of argument, to be sure. I would love to be there. I've read the lengthy contending "briefs." Historic. Is health care properly "interstate commerce" within the jurisdiction of Congress? That is the principal question, IMO. Not that it's the only one relevant to this dispute, a dispute with the most profound of implications.

"COMMERCE,? "MARKETS"?

From my Atlantic Monthly

What Isn’t for Sale?
Market thinking so permeates our lives that we barely notice it anymore. A leading philosopher sums up the hidden costs of a price-tag society.

By MICHAEL J. SANDEL

THERE ARE SOME THINGS money can’t buy—but these days, not many. Almost everything is up for sale. For example:

• A prison-cell upgrade: $90 a night. In Santa Ana, California, and some other cities, nonviolent offenders can pay for a clean, quiet jail cell, without any non-paying prisoners to disturb them.

• Access to the carpool lane while driving solo: $8. Minneapolis, San Diego, Houston, Seattle, and other cities have sought to ease traffic congestion by letting solo drivers pay to drive in carpool lanes, at rates that vary according to traffic.

• The services of an Indian surrogate mother: $8,000. Western couples seeking surrogates increasingly outsource the job to India, and the price is less than one-third the going rate in the United States.

• The right to shoot an endangered black rhino: $250,000. South Africa has begun letting some ranchers sell hunters the right to kill a limited number of rhinos, to give the ranchers an incentive to raise and protect the endangered species.

• Your doctor’s cellphone number: $1,500 and up per year. A growing number of “concierge” doctors offer cellphone access and same-day appointments for patients willing to pay annual fees ranging from $1,500 to $25,000.

• The right to emit a metric ton of carbon dioxide into the atmosphere: $10.50. The European Union runs a carbon-dioxide-emissions market that enables companies to buy and sell the right to pollute.

• The right to immigrate to the United States: $500,000. Foreigners who invest $500,000 and create at least 10 full-time jobs in an area of high unemployment are eligible for a green card that entitles them to permanent residency.

NOT EVERYONE CAN AFFORD to buy these things. But today there are lots of new ways to make money. If you need to earn some extra cash, here are some novel possibilities:

• Sell space on your forehead to display commercial advertising: $10,000. A single mother in Utah who needed money for her son’s education was paid $10,000 by an online casino to install a permanent tattoo of the casino’s Web address on her forehead. Temporary tattoo ads earn less.

• Serve as a human guinea pig in a drug-safety trial for a pharmaceutical company: $7,500. The pay can be higher or lower, depending on the invasiveness of the procedure used to test the drug’s effect and the discomfort involved.

• Fight in Somalia or Afghanistan for a private military contractor: up to $1,000 a day. The pay varies according to qualifications, experience, and nationality.

• Stand in line overnight on Capitol Hill to hold a place for a lobbyist who wants to attend a congressional hearing: $15–$20 an hour. Lobbyists pay line-standing companies, who hire homeless people and others to queue up.

• If you are a second-grader in an underachieving Dallas school, read a book: $2. To encourage reading, schools pay kids for each book they read.

WE LIVE IN A TIME when almost everything can be bought and sold. Over the past three decades, markets—and market values—have come to govern our lives as never before. We did not arrive at this condition through any deliberate choice. It is almost as if it came upon us.

As the Cold War ended, markets and market thinking enjoyed unrivaled prestige, and understandably so. No other mechanism for organizing the production and distribution of goods had proved as successful at generating affluence and prosperity. And yet even as growing numbers of countries around the world embraced market mechanisms in the operation of their economies, something else was happening. Market values were coming to play a greater and greater role in social life. Economics was becoming an imperial domain. Today, the logic of buying and selling no longer applies to material goods alone. It increasingly governs the whole of life.

The years leading up to the financial crisis of 2008 were a heady time of market faith and deregulation—an era of market triumphalism. The era began in the early 1980s, when Ronald Reagan and Margaret Thatcher proclaimed their conviction that markets, not government, held the key to prosperity and freedom. And it continued into the 1990s with the market-friendly liberalism of Bill Clinton and Tony Blair, who moderated but consolidated the faith that markets are the primary means for achieving the public good.

Today, that faith is in question. The financial crisis did more than cast doubt on the ability of markets to allocate risk efficiently. It also prompted a widespread sense that markets have become detached from morals, and that we need to somehow reconnect the two. But it’s not obvious what this would mean, or how we should go about it.

Some say the moral failing at the heart of market triumphalism was greed, which led to irresponsible risk-taking. The solution, according to this view, is to rein in greed, insist on greater integrity and responsibility among bankers and Wall Street executives, and enact sensible regulations to prevent a similar crisis from happening again.

This is, at best, a partial diagnosis. While it is certainly true that greed played a role in the financial crisis, something bigger was and is at stake. The most fateful change that unfolded during the past three decades was not an increase in greed. It was the reach of markets, and of market values, into spheres of life traditionally governed by nonmarket norms. To contend with this condition, we need to do more than inveigh against greed; we need to have a public debate about where markets belong—and where they don’t.

Consider, for example, the proliferation of for-profit schools, hospitals, and prisons, and the outsourcing of war to private military contractors. (In Iraq and Afghanistan, private contractors have actually outnumbered U.S. military troops.) Consider the eclipse of public police forces by private security firms—especially in the U.S. and the U.K., where the number of private guards is almost twice the number of public police officers.

Or consider the pharmaceutical companies’ aggressive marketing of prescription drugs directly to consumers, a practice now prevalent in the U.S. but prohibited in most other countries. (If you’ve ever seen the television commercials on the evening news, you could be forgiven for thinking that the greatest health crisis in the world is not malaria or river blindness or sleeping sickness but an epidemic of erectile dysfunction.)

Consider too the reach of commercial advertising into public schools, from buses to corridors to cafeterias; the sale of “naming rights” to parks and civic spaces; the blurred boundaries, within journalism, between news and advertising, likely to blur further as newspapers and magazines struggle to survive; the marketing of “designer” eggs and sperm for assisted reproduction; the buying and selling, by companies and countries, of the right to pollute; a system of campaign finance in the U.S. that comes close to permitting the buying and selling of elections.

These uses of markets to allocate health, education, public safety, national security, criminal justice, environmental protection, recreation, procreation, and other social goods were for the most part unheard-of 30 years ago. Today, we take them largely for granted.

Why worry that we are moving toward a society in which everything is up for sale?

For two reasons. One is about inequality, the other about corruption. First, consider inequality. In a society where everything is for sale, life is harder for those of modest means. The more money can buy, the more affluence—or the lack of it—matters. If the only advantage of affluence were the ability to afford yachts, sports cars, and fancy vacations, inequalities of income and wealth would matter less than they do today. But as money comes to buy more and more, the distribution of income and wealth looms larger.

The second reason we should hesitate to put everything up for sale is more difficult to describe. It is not about inequality and fairness but about the corrosive tendency of markets. Putting a price on the good things in life can corrupt them. That’s because markets don’t only allocate goods; they express and promote certain attitudes toward the goods being exchanged. Paying kids to read books might get them to read more, but might also teach them to regard reading as a chore rather than a source of intrinsic satisfaction. Hiring foreign mercenaries to fight our wars might spare the lives of our citizens, but might also corrupt the meaning of citizenship.

Economists often assume that markets are inert, that they do not affect the goods being exchanged. But this is untrue. Markets leave their mark. Sometimes, market values crowd out nonmarket values worth caring about.

When we decide that certain goods may be bought and sold, we decide, at least implicitly, that it is appropriate to treat them as commodities, as instruments of profit and use. But not all goods are properly valued in this way. The most obvious example is human beings. Slavery was appalling because it treated human beings as a commodity, to be bought and sold at auction. Such treatment fails to value human beings as persons, worthy of dignity and respect; it sees them as instruments of gain and objects of use.

Something similar can be said of other cherished goods and practices. We don’t allow children to be bought and sold, no matter how difficult the process of adoption can be or how willing impatient prospective parents might be. Even if the prospective buyers would treat the child responsibly, we worry that a market in children would express and promote the wrong way of valuing them. Children are properly regarded not as consumer goods but as beings worthy of love and care. Or consider the rights and obligations of citizenship. If you are called to jury duty, you can’t hire a substitute to take your place. Nor do we allow citizens to sell their votes, even though others might be eager to buy them. Why not? Because we believe that civic duties are not private property but public responsibilities. To outsource them is to demean them, to value them in the wrong way.

These examples illustrate a broader point: some of the good things in life are degraded if turned into commodities. So to decide where the market belongs, and where it should be kept at a distance, we have to decide how to value the goods in question—health, education, family life, nature, art, civic duties, and so on. These are moral and political questions, not merely economic ones. To resolve them, we have to debate, case by case, the moral meaning of these goods, and the proper way of valuing them.

This is a debate we didn’t have during the era of market triumphalism. As a result, without quite realizing it—without ever deciding to do so—we drifted from having a market economy to being a market society.

The difference is this: A market economy is a tool—a valuable and effective tool—for organizing productive activity. A market society is a way of life in which market values seep into every aspect of human endeavor. It’s a place where social relations are made over in the image of the market.

The great missing debate in contemporary politics is about the role and reach of markets. Do we want a market economy, or a market society? What role should markets play in public life and personal relations? How can we decide which goods should be bought and sold, and which should be governed by nonmarket values? Where should money’s writ not run?

Even if you agree that we need to grapple with big questions about the morality of markets, you might doubt that our public discourse is up to the task. It’s a legitimate worry. At a time when political argument consists mainly of shouting matches on cable television, partisan vitriol on talk radio, and ideological food fights on the floor of Congress, it’s hard to imagine a reasoned public debate about such controversial moral questions as the right way to value procreation, children, education, health, the environment, citizenship, and other goods. I believe such a debate is possible, but only if we are willing to broaden the terms of our public discourse and grapple more explicitly with competing notions of the good life.

In hopes of avoiding sectarian strife, we often insist that citizens leave their moral and spiritual convictions behind when they enter the public square. But the reluctance to admit arguments about the good life into politics has had an unanticipated consequence. It has helped prepare the way for market triumphalism, and for the continuing hold of market reasoning.

In its own way, market reasoning also empties public life of moral argument. Part of the appeal of markets is that they don’t pass judgment on the preferences they satisfy. They don’t ask whether some ways of valuing goods are higher, or worthier, than others. If someone is willing to pay for sex, or a kidney, and a consenting adult is willing to sell, the only question the economist asks is “How much?” Markets don’t wag fingers. They don’t discriminate between worthy preferences and unworthy ones. Each party to a deal decides for him- or herself what value to place on the things being exchanged.

This nonjudgmental stance toward values lies at the heart of market reasoning, and explains much of its appeal. But our reluctance to engage in moral and spiritual argument, together with our embrace of markets, has exacted a heavy price: it has drained public discourse of moral and civic energy, and contributed to the technocratic, managerial politics afflicting many societies today.

A debate about the moral limits of markets would enable us to decide, as a society, where markets serve the public good and where they do not belong. Thinking through the appropriate place of markets requires that we reason together, in public, about the right way to value the social goods we prize. It would be folly to expect that a more morally robust public discourse, even at its best, would lead to agreement on every contested question. But it would make for a healthier public life. And it would make us more aware of the price we pay for living in a society where everything is up for sale.

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Michael J. Sandel, a political philosopher at Harvard, is the author of "What Money Can’t Buy: The Moral Limits of Markets," from which this article is adapted.

Indeed. I'll be buying this book as soon as it hits the "market." I've been giving the topic a lot of thought for quite some time.

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Zakaria: Health insurance is for everyone

By Fareed Zakaria, TIME.com

Two years ago, Barack Obama signed into law the most comprehensive reform of American health care since Medicare. Most of its provisions haven’t been implemented yet. But the debate about it rages on at every level. Twenty-six states have filed legal challenges to it. And this month the Supreme Court will hear arguments about its constitutionality.

The centerpiece of the case against Obamacare is the requirement that everyone buy some kind of health insurance or face stiff penalties - the so-called individual mandate. It is a way of moving toward universal coverage without a government-run or single-payer system. It might surprise Americans to learn that another advanced industrial country, one with a totally private health care system, made precisely the same choice nearly 20 years ago: Switzerland. The lessons from Switzerland and other countries can’t resolve the constitutional issues, but they suggest the inevitability of some version of Obamacare...

Read the whole thing. Watch the segment on CNN.
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BACK DOWN IN THE TRENCHES:
MY COLLEAGUE KEVIN AND I YESTERDAY

Monitoring a Saturday training session for chart scanning/EHR conversion process we've been helping a REC client with.

I now feel much better about the clutter in my study.

Yet another federal public comment period announcement

“Workflow Assessment for Health IT Toolkit Evaluation.”

Proposed Project
AHRQ is a lead Federal agency in developing and disseminating evidence and evidence-based tools on how health IT can improve health care quality, safety, efficiency, and effectiveness. Understanding clinical work practices and how they will be affected by practice innovations such as implementing health IT has become a central focus of health IT research. While much of the attention of health IT research and development had been directed at the technical issues of building and deploying health IT systems, there is growing consensus that deployment of health IT has often had disappointing results, and while technical challenges remain, there is a need for greater attention to sociotechnical issues and the problems of modeling workflow.

The implementation of health IT in practice is costly in time and effort and less is known about these issues in small- and medium-sized practices where the impact of improved or disrupted workflows may have especially significant consequences because of limited resources. Practices would derive great benefit from effective tools for assessing workflow during many types of health IT implementation, such as creating disease registries, collecting quality measures, using patient portals, or implementing a new electronic health record system. To that end, in 2008, AHRQ funded the development of the Workflow Assessment for Health IT toolkit (Workflow toolkit). Through this toolkit, end users should obtain a better understanding of the impact of health IT on workflow in ambulatory care for each of the following stages of health IT implementation: (1) Determining system requirements, (2) selecting a vendor, (3) preparing for implementation, or (4) using the system post implementation. They should also be able to effectively utilize the publicly available workflow tools and methods before, during, and after health IT implementation while recognizing commonly encountered issues in health IT implementation. In the current project AFIRQ is conducting an evaluation to ensure that the newly developed Workflow toolkit is useful to small- and medium-sized ambulatory care clinic managers, clinicians, and staff...

...The evaluation will be conducted with 18 practices affiliated with one of two Practice-based Research Networks (PBRNs) in Oregon and Wisconsin, and with the Health IT Regional Extension Centers (RECs) in those States. Participants will be recruited who agree to use the Workflow toolkit in their specific health IT project for a minimum of 10 weeks. This will provide an opportunity to observe use of the Workflow toolkit amongst its intended end users, who are best positioned to provide critical feedback to improve the functionality of the Workflow toolkit...

...The estimated total cost to the Federal Government for this project is $793,456 over a 27-month period from September 23, 2011 to December 22, 2013.
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Request for comments
In accordance with the Paperwork Reduction Act, comments on AHRQ's information collection are requested with regard to any of the following: (a) Whether the proposed collection of information is necessary for the proper performance of AHRQ healthcare research and healthcare information dissemination functions, including whether the information will have practical utility; (b) the accuracy of AHRQ's estimate of burden (including hours and costs) of the proposed collection(s) of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information upon the respondents, including the use of automated collection techniques or other forms of information technology.

Click the workflow graphic above for the link to the HIT Workflow Toolkit.
Written comments should be submitted to:
Doris Lefkowitz, Reports Clearance Officer, AHRQ,
by email at doris.lefkowitz@AHRQ.hhs.gov.

Comment period closes May 8th, 2012

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Well, needless to say, I found that interesting, given that I do this very kind of work for my REC, e.g.,


Click either snippet above for the link to the full jpeg for each one. The first one comes from a doc who wasted a bunch of my time (and his), only to decide he wanted to ditch his EHR contract and go back into Vendor Selection, right on the heels of our being accorded sandbox access to the product so that we could begin to map specific workflows, particularly those relating to Meaningful Use compliance.

That had to have been several grand of FTE in the commode.

The latter goes to a project now ramping up full-steam as I write this. The OMs get it, but sustaining staff buy-in / "ownership," well, we shall see. We gave them my WKFL spiel (.pps) in their HQ conference room a few weeks back, and have commenced with a paper charts-to-EHR procedure now being fleshed out. Ambitious project, 9 IM docs, 3 sites, all the docs and their MAs have variations in the way they see patients and chart the encounters (BTW, my .xls workflow data capture tool is posted here, at HealthInsight).
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DIVERSION: THIS JUST IN


Recall my March 2nd post citation of Dr. Novella's video course on "Your Deceptive Mind: a Scientific Guide to Critical Thinking Skills"? (I continue to review it; more to come)

How about The Khan Academy?

Yeah. This drives me back down Into The Weeds':

Abstracting knowledge from the problem-solving activities to which it should relate has damaging effects at many levels. One effect is that formal education becomes focused unduly on personal intellect. Cultivating a narrow range of intellectual skills and temperaments that foster academic success, the culture of education takes interpersonal skills for granted, and devalues manual skills. And it fails to instill the intellectual behaviors and perspectives that foster effective problem-solving (see part V).


In particular, traditional schooling fails to instill high standards of achievement. In most schooling, time is the constant and achievement the variable—precisely the opposite of what true education demands. Students are allotted a fixed amount of time to learn and then permitted to pass exams and courses with a B or C or worse. Inevitably, given the widely varying abilities and inclinations of individual students, not many will have the experience of passing courses at a high level of achievement. This tolerance of lesser achievement is especially harmful when learning is cumulative, that is, when success at one level requires understanding of the material from an earlier level.


Failure to enforce high standards of quality arises from the premise that schooling should instill a fixed core of knowledge, as distinguished from a core of behavior. Teaching high standards of intellectual behavior and teaching a fixed core of knowledge are mutually exclusive when a fixed time is allotted to achieving these goals. One of the three variables (time spent, amount covered and degree of mastery) has to be held constant at a high level, and that constant should be the degree of mastery. Students would differ in the amount they master and the speed with which they do so, but not in the degree of mastery they attain.


Mastery of a core of knowledge should not be the goal of education— especially in an era when knowledge is constantly becoming obsolete and when information technology confers rapid access to more knowledge than anyone can learn and more processing power than anyone’s mind possesses. The goal should be mastering the behaviors involved in applying knowledge to solve problems effectively and efficiently.


Because these principles are ignored, many students pass through 12 or more years of schooling without ever experiencing mastery, while constantly undergoing invidious comparisons to the best students. This system is harmful even for those best students, for they may acquire elitist attitudes, superficial understanding and misplaced confidence that their academic proficiency will translate into effective problem solving. For less successful students, schooling is too often experienced as a caste system rather than a vehicle for personal development. Many students emerge from their schooling with their natural abilities undeveloped and their natural optimism defeated. To fight back, some adopt an attitude of disdain towards education and intellect. These reactions to formal education are like the reaction of dying canaries in a coal mine—highly sensitive indicators of toxic conditions. In varying degrees, many students are left without the capacities and confidence that only achievement can confer and without the expanded horizons that only education can provide.
[Medicine in Denial, pp 229-230]

UPDATE:
INTERESTING SHOOT-OUT AT THE ONC / HIT PRESS CORRAL
 Dr. Mostashari is not amused:

Apparently, doctors who order a lot of imaging tests are more likely to have electronic systems that let them view those images in their offices.

That is the finding of an article appearing in the March 2012 issue of Health Affairs by McCormick and colleagues. This is not a particularly surprising observation. What is surprising is that the authors go far beyond the scope of their research to conclude that “the federal government’s ongoing, multibillion-dollar effort to promote the adoption of health information technology may not yield anticipated cost savings from reductions in duplicative diagnostic testing. Indeed, it is possible that computerization will drive costs in this area up, not down.”...

To which the study authors publicly replied on The Health Care Blog:

Our recent Health Affairs article linking increased test ordering to electronic access to results has elicited heated responses, including a blog post by Farzad Mostashari, National Coordinator for Health IT. Some of the assertions in his blog post are mistaken. Some take us to task for claims we never made, or for studying only some of the myriad issues relevant to medical computing. And many reflect wishful thinking regarding health IT; an acceptance of deeply flawed evidence of its benefit, and skepticism about solid data that leads to unwelcome conclusions...

Place your bets, pass the popcorn...

McCormick, Bor, Woolhandler, andHillemstein conclude in rebuttal of Farzad:

Dr. Mostashari is also correct in reiterating that randomized trials are the best way to assess health IT. In fact, no randomized trial has ever been published that examines patients’ outcomes or costs associated with off-the-shelf health IT systems that dominate the U.S. market. No drug or new medical device could pass FDA review based on such thin evidence as we have on health IT. Yet his agency is disbursing $19 billion in federal funds to stimulate the adoption of this inadequately evaluated technology. Dr. Mostashari is perhaps the only person in our nation who commands the resources needed to mount a well done randomized controlled trial to fairly assess the impact of health IT, and the comparative efficacy of the various EHR options.


Finally, Dr. Mostashari’s unbridled faith in technology is mirrored by his belief that ACOs are the next panacea for health costs and quality. That health policy flavor-of-the-month also remains wholly unproven.

OK, putting aside for the moment the partisan cheap-shot questions begged by their final paragraph:

• ...no randomized trial has ever been published that examines patients’ outcomes or costs associated with off-the-shelf health IT systems that dominate the U.S. market.

Precisely how would you design and execute such a study, particularly at a time when HIT markets are ramping up at warp speed? Which "dominant" off-the-shelf systems would get included (based on what cut-off %'s of current ambulatory and inpatient market shares)?

As I write this (3/13) there are a total of 1,817 "Certified" EHR ambulatory and inpatient systems and modules (including 913 "complete" systems). Who gets "studied," who gets left out? Would these be "Dummy Clinic" mock trials, or operational CER?

What would be the "control" (i.e., stratified representative samples of equivalent paper practices and institutions)?

• No drug or new medical device could pass FDA review based on such thin evidence as we have on health IT.

Are you asserting that we simply don't know? (Rumsfeld's "unknown unknowns"?) Or that we have "evidence," (like your own reported "null" findings) but it is either equivocal or too sparse to lean on comfortably? Moreover, there are plenty of HIT press reports indicating that the FDA wants no part of this potentially radioactive oversight. They have a full plate already. Apropos, see my November 2010 blog post "First, do no Hold Harmless'."

• Dr. Mostashari is perhaps the only person in our nation who commands the resources needed to mount a well done randomized controlled trial to fairly assess the impact of health IT, and the comparative efficacy of the various EHR options.

Methinks you overstate his brief (e.g., see ARRA Title XIII, Subtitle A, Section 3001 et seq). ONC is a very small shop, as federal Beltway entities go. While you could construe Sec. 3001(b)(2)-(10) as requiring HIT "RCTs," it would seem a stretch to me.
 
But, more on the ONC mandate shortly.

Not that I disagree that we need "comparative effectiveness research" broadly -- though, it will be difficult to parse the relative contributory effects of physical workflow, HIT "information" flow, and clinical decision-making (again, see "Medicine in Denial").

• Finally, Dr. Mostashari’s unbridled faith in technology is mirrored by his belief that ACOs are the next panacea for health costs and quality. That health policy flavor-of-the-month also remains wholly unproven.

I find this to be an unhelpful ad hominem low blow. Congress, not Farzard, wrote the authorizing ACO subtitle in PPACA. Whether it turns out to be successful is yet to be determined. I've written about ACOs before. So, yeah, it's as yet "wholly unproven." Help me out here. Are we doing science, or Creation Science? Do the critics have any concrete, plausible counter-proposals? Or, is the paper chart FFS paradigm the terminus of health care progress?

Asked and Answered. You want to help improve HIT effectiveness? 

Change.The.Payment.Paradigm.
 
Not that we need not work simultaneously on HIT "usability." My record as a certifiable Crank on that issue is by now well-established.

I'm not the only one who took issue with the study's final paragraph. From the Health Affairs blog itself:

jgogek Says:
March 12th, 2012 at 6:48 pm
While in general I’m glad to see researchers vigorously defend their research, I’m left wondering about the gratuitous slam against ACOs in the last paragraph of the above blog post. Calling ACOs “flavor-of-the-month” and “wholly unproven” is simply pejorative and has nothing to do with the substance of the research in dispute. It tarnishes the authors’ objectivity. In fact, it makes them seem kind of chippy.

Indeed. One more commenter weighed in, at ModernHealthcare.com

Al Puerini
ModernHealthcare.com, Mar 15. 2012 7:07pm

I completely agree with Dr Mostashari. The only "deeply flawed evidence" is what they used to come to their study conclusions. To say that EHR vendor's "products have undergone mostly modest tweaks" since 2008 is incredibly naive and shortsighted. EHR's have changed dramatically in the last 4 years and many still have much to do to achieve meaningful use. If one cannot see the positve and deep changes in EHR's over the past 4 years as a result of the development of the PCMH and achieving Meaningful Use, then they are not paying attention to what is happening in the real world. And more to come! When hospitals, PCP's and specialists start communicating with each other through their EHR's, the savings will be huge. And that movement is well on its way. Keep up the good fight, Farzad. Your leadership is changing health IT in a strongly positive way.

Al Puerini, MD
President, RI Primary Care Physician Corporation 

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DAVID DRANOVE WEIGHS IN

From Code Red:

...The other item that caught my attention was a study in Health Affairs showing that physicians who have electronic access to test results (via electronic medical records) order more tests than physicians who do not. The New York Times ran both an article and an editorial about the study. The finding is based on a single year of cross-section data. All first year graduate students in the social sciences should immediately recognize that this study suffers from endogeneity bias. The “treatment” (i.e., access to test results through EMR) is potentially correlated with unobservable physician characteristics that end up in the error term of the regression. As a result, causality is in doubt.

Let me offer several candidate explanations for the findings. First, it could be that access to test results encourages doctors to find ways to increase testing (the negative connotation offered by the author and the New York Times.) Second, it could be that some doctors have a technological bent. They tend to order lots of tests and they are first to have access to EMR. Thus, there is a correlation between testing and EMR but the latter does not cause the former. Third, some doctors may order an above average number of tests. Forced by managed care and Medicare to reduce costs, they seek a way to get testing under control. They install EMR which gives them access to prior test results. This allows them to reduce testing , though not by enough to put them below the average. Again, there is a correlation between testing and EMR, but in this case EMR leads to less testing. There may be other possibilities. My point is not that I know what causes what. My point is that no one knows what causes what.

Fortunately, there are research methods that can help sort out causality. I happen to be working on a similar study using these methods. In an upcoming blog, I will share some preliminary findings. My coauthors and I get a similar correlation, but reveal an interesting pattern of causality that may provide hope to those who believe that EMR can rescue the healthcare system.

AND, THE HITS JUST KEEP ON COMIN'

 

ERRATUM

Apropos of "imaging," I ran across this recent paper published by ACS. I snipped out this graphic and annotated it (click to enlarge)
 

To reduce future projected cancers from diagnostic procedures, we advocate the widespread use of evidence- based appropriateness criteria for decisions about imaging procedures; oversight of equipment to deliver reliably the minimum radiation required to attain clinical objectives; development of electronic lifetime records of imaging procedures for patients and their physicians; and commitment by medical training programs, professional societies, and radiation protection organizations to educate all stakeholders in reducing radiation from diagnostic procedures. CA Cancer J Clin 2012;62:75-100. Published 2012 American Cancer Society.

A better than 550% increase in per capita ionizing dose exposure relative to a constant natural sources denominator (2.4 mSv). Interesting. I started my white collar career in 1986 doing environmental dose/exposure related stuff in a forensic-level Rad/Mixed Waste lab in Oak Ridge, under the esteemed John A. Auxier, PhD and his stable of top-tier Health Physicists, so I found these data intriguing.
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NEW COMMONWEALTH FUND REPORT

Executive Summary
People in the United States, regardless of where they live, deserve the same opportunities to lead long, healthy, and productive lives. Achieving that goal means that all communities should receive the very best from their local health care systems. Yet this new Scorecard on Local Health System Performance finds that where one lives has a major impact on the ability to access health care and the quality of care received. Comparing the 306 local health care areas, known as hospital referral regions, in the United States, the report finds wide variations on key indicators of health system performance. Access to care, quality of care, costs, and health outcomes all vary significantly from one local community to another, both within larger states and across states. There is often a two- to threefold variation on key indicators between leading and lagging communities. The 30 top-performing local areas include communities in the Northeast, Midwest, and a few West Coast communities—with these leading areas often doing well on multiple indicators and dimensions of care. Yet while pockets of excellence exist, there are ample opportunities for health system improvement in all communities, even among the leaders...

98 pages of incisive stuff. Below, this is pretty interesting.

As is this:

Can you say "Gawande"? You could spend a month just interpreting this stuff. Couple of words and phrases come straight to mind: "Disparities," "Health Impact Assessments."
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More to come...