Like the walls of Jericho, the purported justifications for the ways in which government bureaucrats are micromanaging American healthcare just keep tumbling down. The latest victims are so-called “pay-for-performance” schemes and America’s virtual death march toward the mandatory deployment of fancy electronic medical record systems.
In case you hadn’t heard, pay-for-performance (“P4P” for short) is a strategy in which government regulators or insurers use money to motivate doctors to do whatever it is they wish them to do. While this is often couched in positive terms (i.e., “we will pay you extra to do what we want”) this particular management tool can be used as either a carrot or stick. For example, here in Portland, Oregon, Providence Health Plan currently rewards doctors with slightly higher insurance payments if they engaged in each of three activities: using electronic billing, using electronic medical records (EMRs, which are also called “electronic health records” or “EHRs”), and accepting Medicare and Medicaid patients into their practices. However the Federal government has turned this around by saying that Medicare providers who do not use EMRs by 2015 will have their Medicare payments cut by an additional 1% for each year of non-compliant behavior. Similar penalties will apply to e-prescribing beginning in 2012.
You might think that there is nothing wrong with using a few bucks to “encourage” desirable behavior and discourage wrong-doers, and in some cases you’d be right. After all, the government imposes fines for littering all of the time, and some insurance policies will give you discounts for not having accidents. But attempting to manipulate people like this is a funny thing. Sometimes it’s hard to discern what’s “right” and what’s “wrong”. For example if a pharmaceutical company offered to pay doctors to prescribe one of their drugs that clearly increased life expectancy for people who take it, it would be illegal. But if the government mandates that doctors buy and use healthcare information technology that has few or no documented benefits and might actually harm people, proponents of the technology (such as Medicare chief Dr. Don Berwick) might label that as “the future of health care itself” and “a win-win, right across the board”.
“Hey”, one might ask, “what’s up with that?”
Good question. America appears to have turned over its healthcare policy making to people who: (a) don’t know much about healthcare; (b) don’t know much about setting rational and effective policy; (c) govern hypocritically; or (d) practice some combination of these. This reality has been driven home by several recent scientific studies that everyone should know about. The first of these deal with electronic medical records. Others deal with the concept of pay-for-performance itself as a tool for managing doctors and other healthcare providers. We’ll discuss the latter in our next post.
Let’s start with the new research about EMRs. As you may know, evidence-based medicine is all the rage these days. President Obama is all for it. In a press briefing on July 22, 2009 he had this to say:
“Part of what we want to do is to make sure that those decisions are being made by doctors and medical experts based on evidence, based on what works…. Right now, doctors a lot of times are forced to make decisions based on the fee payment schedule that’s out there. … the doctor may look at the reimbursement system and say to himself, ‘You know what? I make a lot more money if I take this kid’s tonsils out … I’d rather have that doctor making those decisions based on whether you really need your kid’s tonsils out, or whether … something else would make a difference…. So part of what we want to do is to free doctors, patients, hospitals to make decisions based on what’s best for patient care.”
Meanwhile, President Obama’s chief of Medicare and Medicaid, Dr. Don Berwick, claimed that:
“Evidence-based medicine” is not just a catch phrase; it is a promise we want to make to our patients – to use all the care – and only the care – that can help them…
Through modern clinical epidemiology, technology assessment, and clinical research, we have developed powerful new tools to assemble, digest, and judge the evidence-base for clinical practice. Rational care plans can emerge, based firmly in scientific evidence, and drawing on research published in hundreds of journals that serve as the basis for the expert opinions and guidance of professional medical societies. Intermediaries have emerged – some call them “cybrarians” — to write and update the convenient, helpful, reliable “black books” of digested knowledge, much like those that we all kept at our side in training days..”
So what does the available evidence say about the safety and effectiveness of the EMRs being deployed under the “pay-for-performance” mandates of the Health Information Technology for Economic and Clinical Health Act (HITECH) Act?
Two landmark studies have been recently published on this topic. The first one by Romano and Stafford was published in the Archives of Internal Medicine. These two investigators used data from the 2005-2007 National Ambulatory Medical Care and National Hospital Ambulatory Medicine Surveys to examine the effect of EMR use on 20 different “quality of care” indicators. They compared the evidence for encounters that did not use EMRS, encounters that used EMRs, and encounters that used EMRs with so-called “clinical decision support” (CDS) capabilities that alert, remind or direct doctors to do certain things according to clinical guidelines of care. The data were compared for over one-quarter million patient encounters.
What they found was that the use of EMRs improved the performance of just a single quality measure – diet counseling in high risk adults.
“In the other 19 indicators, there was no statistically significant difference in quality based on the presence or absence of an EHR. These patterns were present both in bi-variate analysis and in multivariate logistic regression models. Non-statistically significant differences of greater than 5% favored EHR use in 3 instances and lack of EHR use in 2 instances. In the context of multiple comparisons across quality indicators, these findings suggest no association between EHR use and quality.
Clinical decision support also was not associated with higher-quality care. Among EHR visits, CDS was associated with better performance on only 1 of 20 ambulatory care quality indicators: avoidance of unnecessary electrocardiography during routine examinations… In the other 19 indicators, there were no significant differences in quality. Non-statistically significant differences of greater than 5% favored CDS in 1 instance and EHRs without CDS in 3 instances. Given the multiple comparisons, our findings indicate no association between CDS and quality.”
Dr. Scot Silverstein has written an excellent blog post that discusses a published response to the findings of this study.
Then within one week, a second study was published in the journal PLoS Medicine. This one was a systemic review of all reviews discussing the clinical impact of electronic medical records published between 1997 and 2010. The investigators looked at a total of 108 review publications and analyzed them to summarize what the scientific literature says that we know about the risks and benefits of EMRs. Lo and behold, they too found that the data supporting the use of EMRs, computerized physician order entry, e-prescribing and clinical decision support was weak or non-existent, and balanced by similar data demonstrating potential risks posed by use of these systems.
“Although a number of reviews purporting to assess the impact of EHRs were found, many of these in fact investigated auxiliary systems such as CDSS, CPOE, and ePrescribing. As a result, most of the impacts assessed were more relevant to these other systems. We found only anecdotal evidence of the fundamental expected benefits and risks relating to the organisational efficiency resulting from the storage and management facilities within the EHR and thus the potential for secondary uses… We did find, however, a small amount of secondary research relating to time efficiency for some health care professionals and administrators and data quality (in particular legibility, completeness, and comprehensiveness), which demonstrated weak evidence of benefit for both. Risks largely went ignored apart from anecdotal evidence of time-costs associated with recording of data due to both end-user skill and the inflexibility of structured data, increased costs of EHRs, and a decrease in patient-centeredness within the consultation.”
Given the enormous cost and potential risks and benefits to patients supposedly associated with these technologies, the authors rightly asked why more attention has not been paid to specifically proving the safety and effectiveness of these technologies.
“Our major finding from reviewing the literature is that empirical evidence for the beneficial impact of most eHealth technologies is often absent or, at best, only modest. While absence of evidence does not equate with evidence of ineffectiveness, reports of negative consequences indicate that evaluation of risks – anticipated or otherwise – is essential. Clinical informatics should be no less concerned with safety and efficacy than the pharmaceutical industry. Given this, there is a pressing need for further evaluations before substantial sums of money are committed to large-scale national deployments under the auspices of improving health care quality and/or safety.”
The nature of these risks should not be understated, especially in light of the vendor and government-driven initiatives that have characterized the deployment of these technologies for the past decade. With Presidents and their appointees pushing HIT, no one in a position of power or responsibility has wanted to look for, much less find defects in their magical thinking. Again, Dr. Silverstein has recently found that a whole truckload of troubling reports about HIT are now flowing into the FDA’s MAUDE (Manufacturer and User Facility Device Experience) database.
We’ll deal with using P4P as a tool for managing the clinical behavior of doctors and other healthcare providers in our next post, but what does what we’ve learned so far tell us about the legitimacy of pay-for-performance as a tool in the hands of America’s health policy leaders?
Take a second to re-read the comments that President Obama and Dr. Berwick made earlier with respect to the importance of valid scientific evidence when making decisions in healthcare. President Obama laments the fact that the existing RBRVS system may distort medical decision-making by giving providers a financial incentive to take actions that may not be evidence-based. He is correct in this, and (as we’ve written previously) the entire RBRVS system should be scrapped. Meanwhile Dr. Berwick reminds us that “Evidence-based medicine is not just a catch phrase; it is a promise we want to make to our patients – to use all the care – and only the care – that can help them.” Yet in the case of EMRs, e-prescribing and other healthcare information technologies we now have a situation in which the Federal government itself is creating and enforcing financial incentives to purchase and use technologies that have no good scientific evidence that supports their use. Still worse, research into the potential risks associated with their use has been ignored entirely. It’s really no different than having these same “evidence-based” government officials mandate payments for the use of an expensive, complex and potentially disruptive but inadequately studied set of surgical procedures, while completely ignoring any discussion of their potential risks. Tell us again, how this is any different from the RBRVS system that President Obama deplores? And where were Dr. Berwicks’ “cybrarians” while all of this is going on? Do our healthcare policy leaders believe in evidence or not when it comes to making public policy that will affect the lives of hundreds of millions of Americans?
If we’re serious about maximizing quality and minimizing cost in healthcare, here’s a P4P program that’s long overdue. Let’s pass a law that deletes a substantial fraction of salary compensation and/or time in office for any government or insurance company official who makes healthcare policy decisions that are not evidence-based.
This approach is guaranteed to result in far fewer regulatory decisions and P4P programs in healthcare. And with all of the salary givebacks, it might even balance the Federal budget.
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