Health Care Reform Three Years Later - An Insider's Assessment

It’s been three years since the Patient Protection and Accountable Care Act (PPACA) became law.  There have been widely divergent opinions published by journalists on the impact of the law for Americans: from a rose-colored account from the New York Times, to a not-so-peachy account published at Reason.com.  Few doctors have ventured into this discussion.

The Need for Health Care Cost Reform

I should start by saying that I am biased.  I grew up in the days of an idealized image of the physician –where doctors were still held in relatively high esteem by our society.  I had to think this way for I was joining the system.  Back then, like now for the younger doctors, medicine was a still considered a calling, not just a job.  The unspoken code was that it was the patient above all else: screw the establishment, screw hospital loyalty, screw the drug company – if they couldn’t help your patient, you’d take them elsewhere.  So hospitals courted doctors.  Drug companies courted doctors.  Insurance companies courted doctors.  But the truth be known, doctors weren’t the apple in everyone’s eye, patients were.  And doctors enjoyed the limelight – so much so, that a few in our ranks succumbed to the greed, too.  After all, like now, patients paid everyone’s bills.

But health care costs for patients became increasingly hard to cloak.  Insurance companies, in the business of making the expensive seem cheap, needed an exit strategy.  The new hospital buildings, multi-million dollar corporate earnings, drug innovations costing tens of thousands of dollars, and the aging population that was growing too quickly weighed heavily on the entire system’s sustainability.  Something had to be done.

The First Steps

So without belaboring the obvious: we created Health Care Reform as we know it.  Health Care Reform wasn’t just the PPACA, though, but rather a carefully orchestrated series of legislative achievements that laid the groundwork for payers to offload the costs of health care on to the only other entity that could pay these high costs: our government. 

The process (as we have seen) first involved an expensive, multibillion computer roll-out that was part of the American Recovery and Reinvestment Act.  These computer systems promised “cost savings” by “improving efficiencies” of care.  Information systems were sold as our salvation from cost excesses like $15 Tylenols.  Corporate America (and their political lobbyists) bought it and so did the government.  To keep doctors quiet, doctors were promised $44,000 a piece to install computers in their offices.  Little did they realize their payments from government to private offices were to be slashed forty percent in the same legislation and computers would be required to bill the government.  So, the $44,000 actually went to doctors’ new employers.  Doctors were thanked for their services with a new $700-dollar iPad and a treasure trove of Meaningful use regulatory benchmarks that slowed patient care rather than sped it.

Our New "Reform"

Next came the PPACA, our signature health care law.  The law was spun as a way to save health care costs while adding 34 million more uninsured patients to the system.  Pulling heart strings was much more palatable politically than the much needed reality of fiscal restraint.

But we should admit that our health care system has flaws when it comes to the uninsured.  To prove the health care reform’s benefits, the easy-to-sell low-risk coverage for young adults was given as a loss leader to the new health care law's Health Care Happy Meal.  This benefit was universally welcomed by all because it was needed.  Yeah, it cost a bit more to provide this insurance, but in the scheme of things, the cost of this health care was relatively cheap to provide.  It was (and remains) a win-win. But our attachment to this part of the law may be a clever way to buy us off.

Preventative services, provided for free, were also included in the PPACA.  But this is a problem because nothing is free in health care.  Proving preventative services for free perpetuates an expectation that everything will be free in health care and have no consequences.  After all, preventative services take time and time for care providers overloaded with more and more patients entering the system is our most precious commodity.   Others argue that catching problems early will save money but the proof that this makes a difference to health care costs is really just a delightful narrative.  In fact, even the annual physical’s benefit to our health care has been called into question – especially when we recognize its value to the system compared to the benefits derived for the patient.

And people have argued that the PPACA has already reduced costs.  While I am not an economist, I really can’t speak to this.  I am just a worker and observer.  These days I see four or five administrators where, just a few short years ago, we had one.  I see fewer nurses with less experience caring for more patients now.  I see bigger buildings but fewer patient beds as wards are consolidated.  I see hospital-system employers with hiring freezes that are laying off workers in anticipation of upcoming costs imposed by the new law. 

How's the Quality?

And then there’s the overall quality of care.  I can’t say I really see a difference from five years ago.  Sure, I see things being done faster by fewer.  I see computers moving information around like never before.  But is the care to our patients really better?  I see reams and reams of documentation made not for the patient’s benefit, but for bureaucrats and bean-counters more interested in our use of computers than our patients.  I see better communication between doctors improved with the EMR, but has this translated to better care delivery? Not always. And when it comes to quality, the New York Times editors cited the example that health care in America is cheaper because Medicare patients have fewer re-admissions since the PPACA was enacted.  But they also failed to note that hospitals receive financial incentives to reward this behavior.  They claim this is “better coordination of care” while ignoring the fact that patients are labeled with scarlet A’s and shunted to health care facilities that don’t "count" as re-admissions.  They also failed to mention the effects of the higher costs that patients see from their higher insurance premiums.  Cha-ching.

What's Ahead

In the end, health care reform is still about the money for the system rather than the real needs of most patients.  We are cutting costs to corporations by inflating our Health Care Hindenburg with cheaper hydrogen.  We have spun a narrative of providing more care for more people with less cost while ignoring the shear forces and telltale weather patterns of cost concerns that blow our way and threaten our ship's buoyancy.  

Some doctors have leapt from the ship.  More will certainly follow.  Others remain silent yet quietly discontented; they do their job as just job now, marking time with little incentive for doing more.  They have become the common workforce drone  increasingly asked to do more by those who go home at 5pm and have no liability for the care they provide.  More risk with less reward has been the mantra for care providers in health care reform.  The stress is growing for everyone.   Unfortunately, the doctors that leave will soon be back-filled by well-meaning young physicians with fewer hands-on hours of training that have been sculpted by an educational system dependent on tenured med-school professors complicit with our new progressive mindset. 

Health care reform is here, alright, doing what it's always done: spinning reform without real reform for three years (so far) and counting.

-Wes

Patient Safety and the Ethics of EMR Implementation

“An experiment is ethical or not at its inception, it does not become ethical post hoc – ends do not justify means. There is no ethical distinction between ends and means.”

-- Henry K. Beecher, MD

“Ethics and Clinical Research,”

 New Engl J Med 274(24) June 16, 1966 pp 1354-1360.

"When everything is digitalized, all your records - your privacy is protected, but all your records on a digital form - that reduces medical errors. It means that nurses don't have to read the scrawl of doctors when they are trying to figure out what treatments to apply. That saves lives; that saves money; and it will still ensure privacy."

- President Barack Obama

The implementation of the electronic medical record (EMR) in American medicine gained a powerful foothold in medical care with the passage of the American Reinvestment and Recovery Act (ARRA) in 2009. With the passage of this act came the promise of improved efficiencies, safety and ultimately reduced cost delivery for health care. Also, some $18 billion dollars in financial incentives were offered to physicians to offset costs to deploy these systems nationwide. To assure adoption, if the systems were not implemented by 2015, doctors and care providers will suffer payment penalties from the government. For physicians who care for Medicare patients, there was no alternative than to deploy these systems.

In 2010 alone, the EMR market was pegged at $15.7 billion dollars, a cost that is ultimately passed to all Americans. In addition, despite all of the changes that health care reform has brought to date, people in some states continue to see their insurance premiums mushroom over 20% in 2013 from the preceding year. Simply put, patients are finding health care anything but “affordable.”

We should acknowledge that there might be cause, ethically, to deploy a technology that truly benefits patients at some cost. After all, you have to break a few eggs to make a good omelet. If interoperability of EMR systems between facilities were commonplace and clinical data were shared with ease while patient privacy was vigorously upheld flawlessly, the cost of these systems might be ethically justified.

But the promise of improved efficiencies to our health care system, improved patient safety and (especially) reduced cost for our health care system remain elusive. More importantly these goals remain unproven. In fact, examples that the opposite is occurring abounds as doctors struggle to enter ever-increasing amounts of information of no relevance to the patient’s presenting problem just to prove they’re using the EMR in a “meaningful” way, health data security breeches continue, errors are growing instead of shrinking, data-mining of patient information is occurring not just for patient care but for marketing purposes, and the direct costs of health care for patients continues to rise, not fall. Proponents of these systems will argue these issues are nothing more than “growing pains” of these novel systems.

So should we step back for a moment and ask ourselves if we are being ethical to patients with the deployment of this technology? Does the ends of presumed cost savings to our national health care system justify the deployment of poorly integrated, difficult-to-use systems? Are patients being subjected to new risks heretofore never considered with the adoption of this technology? Could a tiny programming error occur that negatively impacts not just one patient, but millions? If so, what are the safeguards in place to prevent catastrophic error? Who will be responsible? Who is the oversight body that assures the guiding principles of the Belmont Report (respect for persons, beneficence and justice) with respect to EMR deployment are followed? The Secretary of the Department of Health and Human Services or a more nebulous body like Congress?

If we accept that the benefits of the EMR are at least uncertain to patients in terms of risk and cost, we should demand they be studied before deploying them. The guiding medical ethics tenets would demand nothing less. So, would not such study qualify as human research? After all, we should remember that the United States and other countries have a precedent of human research programs performed by government agencies that were usually highly secretive, and in many cases information about them was not released until many years after the studies had been performed.

From a sentinel paper in 1966 by Henry J. Beecher, MD on Ethics in Research:

"I should like to affirm that American medicine is sound, and most progress in it soundly attained. There is, however, a reason for concern in certain areas, and I believe the type of activities to be mentioned will do great harm to medicine unless soon corrected. It will certainly be charged that a mention of these matters does a disservice to medicine, but not one so great, I believe, as a continuation of the practices cited.

Experimentation in man takes place is several areas: in self-experimentation; in patient volunteers and normal subjects; in therapy; and in the different areas of experimentation on a patient not for his benefit but for that, at least in theory, of patients in general."

While Beecher’s paper was addressing ethical research errors in general, his words are oddly prescient for EMR development. Ethical errors, as he pointed out, “are increasing not only in numbers but in variety.” He points to one of the biggest drivers of ethical conflict: money.

“Of transcendent importance is the enormous and continuing increasing in available dollars for research, as shown below:

Money Available for Research Each Year

Year	Massachusetts General Hospital	National Institutes of Health
1945	$500,000	$701,800
1955	2,222,816	36,063,200
1965	8,384,342	436,600,000

These data, rough as they are, illustrate vast opportunities and concomitantly expanded responsibilities.

Taking into account the sound and increasing emphasis of recent years that experimentation in man must precede general application of new procedures in therapy, plus the great sums of money available, there is reason to fear that these requirements and resources may be greater than the supply of responsible investigators.”

The need for “responsible investigators” remains significant; funding for all of the National institute of Health in 2011 was $142.5 billion dollars. Annually, EMR companies have received the equivalent of 11% of the entire NIH annual research budget from US citizens without having to prove their safety or value to patients.

Again, from Beecher’s paper:

“The ethical approach to experimentation in man has several components; two are more important than others, the first being informed consent. The difficulty of obtaining this is discussed in detail. But it is absolutely essential to strive for it for moral, sociologic, and legal reasons. The statement that consent has been obtained has little meaning unless the subject or his guardian is capable of understanding what is to be undertaken and unless all hazards are clear. If these are not known this, too, shall be stated. In such a situation the subject at least knows that he is to be a participant in an experiment. Secondly, there is the more reliable safeguard provided by the presence of an intelligent, informed, conscientious, compassionate, responsible investigator.”

Because EMR deployments are cloaked in intellectual property, non-disclosure and restrictive hospital employment agreements, doctors are often prohibited from voicing specific concerns about an EMR system publicly. In addition, by adopting EMR systems as cornerstones of the American health care system, Congress, the President and the ARRA side-stepped patients’ informed consent regarding the short-comings of these systems, advertising only their desired benefits instead. Furthermore, rather than Congress turning to “conscientious, compassionate, responsible investigators,” they turned to lobbyists when deciding to fund the deployment of unproven EMR systems. As a result, doctors were relegated to becoming nothing more than stewards of data entry subject to new, ever-evolving documentation requirements as these systems evolve for cost-saving benefits and care "efficiencies."

Patients and doctors alike understand the need for improved efficiencies and value in our era of exploding health care costs. We must strive to find a solution to our health care cost crisis that is transparent, cost-effective and ethical. Without such an effort, our health care system will collapse. Only recently has the Office of the National Coordinator of Health Information Technology recognized the problem and opened their Health IT Patient Safety Action and Surveillance Plan for public comment. This plan asks the EMR companies and interested stakeholders to develop their own methods to assure patient safety and reporting systems – a move that approaches the same ethical standards as equivalent of asking the foxes to watch the henhouse. Nonetheless, we should acknowledge their efforts.

But we should be cautious of EMR systems as we move forward. After all, these clinical systems have not been subjected to the same cost-benefit and ethical scrutiny as other clinical tools we use in health care. The scrutiny of EMRs should be no different than that found with pharmaceutical or medical device research where Institutional Research Board approval and proof of no conflict of interest is demanded. Why should clinical EMR systems be any different?

Given the profit motives and market consolidation occurring amongst the purveyors of these EMR systems and the potential for lethal EMR errors both from software and human interface issues, doctors and patients must especially question the ethics of the movement to deploy untested, novel technology on our patient population under restrictive covenants. As part of informed consent, patients should have full understanding of how and where their clinical data are used, including when it will be used for direct-marketing campaigns, prioritizing care delivery, or for research. Patients should be able to opt out of the use of their clinical data for these or any other purpose if desired, without restricting payment for care. Finally, physician and patient concerns about EMR systems should be allowed to be vetted publicly and without threat of professional or personal reprisal or the withholding of payments for care rendered, especially and particularly if these disclosures are performed in the best interest of patient care.

To do otherwise is unethical for our patients and the public at large.

-Wes