Monday, September 3, 2012

The Manufactured Crisis of Quality in American Healthcare

The Affordable Care Act is the culmination of changes to our health care system that has been decades in the making. Due to public policy over-aggressiveness by some and insufficient vigilance by others, we are now arriving at the beginning of a new health care era in America.

The federal government of the United States of America has assumed responsibility for the “quality” of care provided by our health care system. Superior results from the American healthcare system provided for patients are disregarded and trumped by the federal standardization and control of the medical system.

These policies have been advanced under the guise of interchangeable terms like “evidence-based medicine,” “guidelines,” “best practices,” and “protocols,” and the net result for the medical community is an unmistakable encroachment on the patient-doctor relationship. Evidence-based medicine, as determined by a record in a database, should never be confused with results-based medicine, as determined by the patient.

Standardization

The Institute of Medicine (IOM) describes the primary “quality” problem in health care today as the “overuse,” “underuse,” and “misuse” of health care services.6-8

The Agency for Healthcare Research and Quality (AHRQ) equated quality with the standardization of care in the 2007 National Healthcare Quality Report: “One goal of quality improvement efforts nationally is to reduce differences in health care quality that patients receive in one state versus another. There is no justification, for example, for a patient hospitalized for a heart attack in California to have different care than a patient in Alabama.”121

This argument is familiar to the business community and other areas of our society. Much thought and talk has been devoted to “process” and the consistency of a user experience. McDonald’s wants their “Meal #1” to be the same anywhere in the country.

Raising geography is mostly relevant for purposes of crossing state lines (interstate commerce) and triggering justification for federal intervention. Geography, however, is a poor criteria for standardizing health care. Standardization of medical care in general reduces the ability of clinicians and medical practitioners to customize care for an individual’s needs.

At McDonald’s, you can customize the condiments on the sandwich you get with your Meal #1. When the government standardizes your care, there is no individual customization, and the penalties on clinicians for such customizations become harsh.

The chosen method for standardizing health care to reduce “overuse,” “underuse” and “misuse” of health care services is the development and enforcement of clinical guidelines—essentially practice directives.

Chronicling the history of medical standards, Eleanor Kinney quoted the federal Physician Payment Review Commission in 1988: “Practice guidelines may be unique among available methods to contain costs in that they can increase the quality and efficiency of care in the process of slowing increases in expenditures.”176

According to Eleanor Kinney, in 1988 the Health Care Financing Administration and the Public Health Service poured millions of dollars into research aimed at "develop[ing] the scientific basis for medical standards of care."177

Note the contradiction. Science is about the exploration of knowledge. Standardization is about suppression of deviation from a norm. Scientific discovery can be as varied as the individual researcher, and standardization is about having as little variation as possible.

Gary Belkin, M.D., Ph.D., from Harvard University argues that calling the process "scientific" is the mechanism being used today to shift power and control away from physicians--and undermine the doctor's longstanding role as medical expert: “By offering a scientific solution, [managed care] can finally crack the nut plaguing health policy for the past decades: reconciling global budgeting decisions with individual physician behavior.”45

Raising “global budgeting decisions” over patient care has been the goal in the private sector. Managed care organizations began developing guidelines in the 1990s to identify inappropriate medical care and reduce unnecessary utilization of services.2 Note, these are non-medically trained people determining care to be “inappropriate” and “unnecessary,” specifically for purposes of reducing costs.

The public sector has other reasons for shifting control from medical professionals to “researchers,” executives and policy makers. Arnold Rosoff, speaking at a workshop sponsored by the Agency for Healthcare Research and Quality (AHRQ) and the Institute of Medicine in April 2000, said, “This latter group views the country's health care needs, and thus leans toward allocating its health care resources, using a systems approach, looking at issues on a macro rather than micro level, and employing population-based rather than individual-based measures.”

In other words, this is about “reining in physicians' natural inclination to treat each patient as a special case” and instead conduct health care activities “in terms of population-wide statistics.”48 This is the essence of socialized medicine.

Population Management

Words like “research,” “quality,” and “patient,” take on a whole different meaning when considered in terms of a “population” instead of an individual. They become code words for other things. “Research” and “evidence” become process and procedures. “Quality” becomes compliance with those procedures. “Patients” become data points.

The conforming of medical practice for an entire population is known as evidence-based medicine (EBM).

According to Dr. Belkin, “evidence” should not be confused with being scientific: "There is great variability within scientific communities as to what evidence, techniques, assumptions, and so on, count as scientific," he writes.96

According to Canadian physician R. Brian Haynes, “Evidence never tells you what to do. The same evidence applied in one case may not apply in another. The circumstances of the individual may be different, or the circumstances may be the same, but patients may refuse one treatment in favor of another. What evidence-based medicine does is inform one about what the best options are—but it doesn’t make the decision.”29

Evidence is subject to a range of vulnerabilities including researcher bias, discordant views, hierarchies of importance, conflicting evidence, flawed research, suppression of negative results, selection bias, data falsification, and an overall dehumanization of the practice of medicine. 76-91

There may be a fundamental misunderstanding of the purpose of research. Rather than being the final authoritative word on medical practice, each study is a contribution of an evolving body of evidence.40

Evidence does not make the decision. Evidence simply contributes to the basis by which people make decisions.

Our criteria for making decisions can also vary. Dr. Belkin: “[T]echniques that people see as objective proof, when more carefully examined, are easily seen to be the result of a multitude of subjective choices.” The “value-laden nature of what is ‘desirable,’ the innumerable choices and disagreements as to outcome variables, interventions, and observed population definition, make the measuring of outcomes anything but straightforward.”98

An important word to consider is “outcomes.” If we are not talking about individuals, what is a desirable outcome for medical techniques applied to a population?

Dr. Belkin: “Social roles, needs and political agendas often determine what scientific claims and methods (outcomes studies vs. individual physician judgment) gain authority such that, what was once anathema becomes gold standard.”97

“Evidence-based medicine” would be better known as procedure-based medicine. Doctors call it cookbook medicine. Any system that assumes the responsibility for an entire population and only sees patients as data points and raises general procedure compliance over individual care could easily produce results that are anathema to patient care according to valuing the individual.

Guidelines

The procedures in question as it relates to medical practice are known as “guidelines.”

Guidelines are not simple lists of action steps or a set of flowcharts. Instead, they are often complex high-level documents that require concentrated reading. Within the guidelines are abstracts, introductory statements, decisionmaking methods, treatment recommendations, flowcharts, matrices, supporting evidence, benefit vs. risk statements, concluding statements and information on the developers.

Guidelines begin with evidence derived from randomized clinical trials. Clinical trialist and cardiologist Dr. Sidney Goldstein estimates that a randomized clinical trial typically costs $50 million to $100 million.36 Once data has been gathered, guideline production can begin.

According to Steven Woolf, M.D., speaking at a conference sponsored by the federal Agency for Healthcare Research and Quality (AHRQ), it takes one to two years to produce a guideline.166 The average cost is about $80,000-$100,000, says Woolf. “The federal government usually spends about $800,000 when they do it,” he said.167

For guideline development, the Institute of Medicine recommends that the “number of priority conditions identified [by AHRQ] grow over time to eventually cover the majority (e.g., 80 percent) of the care provided to patients.”173

The reality is a bit different.

Randomized clinical trials have been performed ... for only a small number of clinical problems.64 Writing in the Canadian Medical Association Journal, Ian Kerridge et al explained, The “large quantities of trial data required to meet the standards of evidence based medicine are available for relatively few interventions.” Further, conditions in clinical trials may not accurately reflect “real world” conditions,72 especially at the population level.

According to Steven Woolf, M.D., speaking at the Evidence-Based Practice of Oncology, 3rd Annual Symposium, “There just aren't enough studies to really do evidence-based guidelines on most of what we do in medicine.”94 Science itself is a limiting factor, he said. “[O]ur current infrastructure for evidence, harvesting the evidence, and so forth, is woefully inadequate.”57

With needs exceeding resources, we will be required to look for other ways to make decisions about resource allocation. Kerridge: “Allocating resources on the basis of evidence may therefore involve implicit value judgments, and it may only be a short step from the notion that a therapy is ‘without substantial evidence’ to it being thought to be ‘without substantial value.’”95 What may be insufficient evidence as a basis for a population guideline may be of sufficient value for an individual patient, yet our lack of data may lead us to believe otherwise.

The few guidelines we have have also bear significant shortcomings.

Guideline development has a poor track record of handling individual exceptional needs, personal impact on patients, special needs, multiple conditions, conflicting recommendations, patient priority over economics, dominance by special interests, scientist researcher opposition, selective interpretation, variations in values, unrealistic controlled environments, circumstances encountered outside the controlled environment, new medical technologies and filtering poor research, poor medical skills, poor methodology.106-130, 66-90

“The quality of the guidelines assessed varied significantly by developer, publication status and drug company sponsorship.”105 Guidelines fail to make explicit how recommendations are devised, leaving practitioners to follow in blind faith.

Guidelines rapidly become outdated. In 2000, a group of researchers determined that more than 75 percent of the guidelines developed between 1990 and 1996 needed updating. In addition, they discovered that half the guidelines were outdated in 5.8 years.

After all is said and done, as Cook and Giacomini from McMaster University in Ontario write in The Journal of the American Medical Association: “[G]uidelines designed to promote cost-effectiveness at the patient level may not maximize cost-effectiveness at the population level,”172 which is the very reason they exist in the first place.

Nonetheless, guideline development is a booming industry, pushed forward with significant taxpayer financing.

Compared to one guideline published per year between 1975 and 1980, there were 454 guidelines published annually between 1993 and 1997.90

In 1996, physicians in one clinic sent their patients a letter stating that a certain health plan's insurance would no longer be accepted because the plan “insists that we follow their version of 'practice guidelines' in the treatment of each [health plan] enrollee, without any safeguards against 'undertreatment,' or withholding of optimum care.”60

In other words, best practice guidelines created one the very problems guidelines were intended to solve: underuse of health care services.

There may be another purpose for guidelines. Sabine Kleinert, an executive editor at The Lancet in Oxford, England, asserts, “In the search for objectivity and firm guidelines the field of evidence-based medicine has quickly advanced to evidence-based decision-making and evidence-based rationing.”144

Fully implemented, evidence-based medicine could lead to a limited list of approved health care services as determined by the agendas and values of powerful individuals in corporate and government offices far from the patient’s bedside.

Medical Community Reaction

Those directly responsible for the practice of medicine are noticing the effects of the guidelines. As written in QJMed, “Evidence-based medicine involves a takeover of the clinical consultation by an alliance of managers and their statistical technocrats who are empowered to define ‘best practice,’” yet retain no responsibility for the clinical consequences.22

Relatively few patients, perhaps less than 25 percent, fit the evidence-based therapeutic paradigm.13 Individuals vary by physiology, mental capacity, emotional stamina, time constraints, family and cultural considerations, financial status, drug and food allergies, willingness to comply, ethnic background, ability to travel, relationship resources, and side effects to medication, among other factors. As genetic researchers increasingly demonstrate, patients are as different as their DNA.

The guidelines are not guidelines in the traditional sense of the term.

One doctor, talking about administrators who question his treatment decisions, told The Seattle Times, “It’s always, ‘Why wasn’t it done this way?’ … From where I sit, I see guidelines become law, mandates.”21

Guidelines produced by governments or payers to control spiraling costs may be resented by clinicians and patients as an invasion of personal autonomy.24 This is the intent. According to Kaiser Permanante Senior Advisor Dr. David M. Eddy, “whoever controls practice policies controls medicine.”102

While a lack of compliance may mean a lack of control for the plan administrators, this does not necessarily imply a lack of value for the individual patient. One doctor says, “[C]ompliance with guidelines does not necessarily translate into appropriate patient care… [P]hysicians who do not follow guidelines are not always wrong.”114

One of the great concerns surrounding practice guidelines is that they do not concentrate on individual patients. They “attempt to make decisions for a collection of patients,” writes David M. Eddy, M.D., Ph.D., at Duke University. The resulting injury can be substantial.

Dr. Eddy warns, “If an individual physician and a patient make a wrong decision, that patient will be harmed, but the damage will stop there. In contrast, practice policies are intended to influence thousands, even millions, of decisions. If a policy is wrong, the harm can be huge.”139 115

Overcoming physician resistance to the usurping their role in medical care requires a series of carrots and sticks.

Carrots

Policy makers have not been shy about offering financial incentives to encourage “onboarding” by the medical community. Some have concerns about how this will affect care provided.

According to Roy B. Verdery, Ph.D., M.D. in The New England Journal of Medicine, “Economic incentives are always subject to ‘gaming,’ inappropriate manipulation of data, and ‘cherrypicking’ of patients by physicians and groups more interested in making money than in providing good care.”41

Financial incentives require monitoring physician behavior including test orders, referrals to specialists, and hospital admissions. According to Linda Peeno, M.D., a former HMO medical director and then a consultant on managed care and health care ethics, physicians subject to profiling linked to financial incentives “reported difficulties with making appropriate medical decisions for their patients. These physicians said they were often torn about doing what is best for the patient while working under a health plan that rewards physicians who control costs by limiting treatment.”57

Debra Stone, from Brandeis University, warns that when payment is based on behavior, the physician's criterion for decision making can be “changed from medically necessary to medically necessary for the patient and financially tolerable for the primary care doctor.”56

Another carrot placed before physicians are “decision support” systems “embedded in the practice environment”104 including “computer-embedded guidelines.”106 This is where practice guidelines and patient records begin to meet.

Making the argument for this added participant in the patient-doctor relationship, then-Senator Hillary Clinton (D-NY) wrote, “Why rely solely on the doctor’s brain to store that information? Computers could crunch the variables on a particular patient’s medical history, constantly update the algorithms with the latest scientific evidence and put that information at the clinician’s fingertips at the point of care… Reminders can take the form of … computerized questions to remind a doctor of the conditions that must be fulfilled before surgery is considered appropriate.”148

David Sackett, author of the EBM definition and a professor at Britain’s National Health Service Research and Development Centre for Evidence Based Medicine, warns against lockstep adherence to scientific evidence, computerized or otherwise. He wrote, “Without clinical expertise, practice risks becoming tyrannised by evidence, for even excellent external evidence may be inapplicable to or inappropriate for an individual patient.”26

Whoever controls the data gets to make the rules, and the rules give control of our patient information to the federal government, implemented through exchanges.

Reginald Coopwood, MD, who has helped states create a health information exchange (HIE) said, “there needs to be an appetite for health data and an iPad of HIE if health information exchange is to reach its potential.”

Electronic Health Records

The necessity of verification of physician activity raises fundamental questions. If physicians are offered incentives for complying with policy directives on patient care, how do those paying the bill verify that compliance? How do we know what happens in the privacy of a doctor’s office, in that interaction between the patient and the doctor?

The old school method was insurance claims. Then mandatory reporting requirements are added. And now there is the electronic health record (EHR). Originally EHRs were a way to organize medical information and control costs by reducing duplication of services.

In 2009, less than one month after President Obama took office, Congress passed and the President signed into law the American Recovery and Reinvestment Act. Contained within that law is another law called the Health Information Technology for Economic and Clinical Health Act (HITECH Act). At the time of enactment, the HITECH Act was called, “the most important piece of health care legislation to be passed in the last 20 to 30 years” and “the foundation for health care reform.”

The Washington Post reported the “inclusion of as much as $36.5 billion in spending to create a nationwide network of electronic health records.” This came after “a sophisticated, decade-long campaign to shape public opinion and win over Washington's political machinery.”

This law would “enable researchers to determine the most effective procedures for an ailment,” the Post report continued, a reference to clinical guidelines, and that such an approach “would rely on unprecedented data-mining into medical records and the practices of doctors.” Whoever controls the data gets to make the rules.

“Finally, we're going to have access to millions and millions of patient records online,” said Blackford Middleton, a physician, Harvard professor and chairman of the Center for Information Technology Leadership, reported the Post. “This is the biggest step for health-care information technology in this country's history.”

In 2010, the Department of Health and Human Services issued a rule listing categories including 701,325 entities and 1.5 million business associates who would have access to patient information without patient consent after the patient had given general consent to their medical practitioner's HIPAA release.

Millions of entities now have access to millions of patient records.

“I would like to believe that the effective use of (health information) technology to augment health care will lead to substantial savings and improvements in the quality of care,” said Mark Frisse, a physician and professor of biomedical informatics at Vanderbilt University, who leads an electronic health record program in Nashville, reported the Post. “But the evidence does not consistently bear this out.” Doctors “have resisted investing in the computers because there was no evidence they could profit from them.” And thus, “a ‘minimum of $25 billion’ in subsidies was needed to spur doctors to buy the technology.”

Explaining the larger purpose of Health IT, the National Coordinator for Health Information Technology Dr. Farzad Mostashari said: “You need information to be able to do population health management. You can serve an individual quite well; You can deliver excellent customer service if you wait for someone to walk through the door and then you go and pull their chart, or you make a new chart for them. What you can’t do with paper charts is ask the question, 'Who didn’t walk in the door?’” Welcome to “meaningful use.” There is now neither privacy nor confidentiality in the patient-doctor relationship.

There is one agency at the center of this nationwide data agenda that has a long and quiet history.

Agency for Healthcare Research and Quality

Originally established in 1989 as the Agency for Health Care Policy and Research (AHCPR), this organization was found in 1996 to have “performed an advocacy role in the health care debate the past 2 years while its funding increased from $125 million in 1992 to $163 million in 1994.” Its funding was almost eliminated as it “functions duplicate of research in other agencies.”

Charles N. Kahn III, then president of the Health Insurance Association of America, testified at a 1999 hearing regarding federal involvement in practice guidelines, that without AHCPR “private health plans alone would have too few resources and too little capacity to produce these types of measures and evidence.”185

AHCPR was reauthorized by Congress, and renamed the Agency for Healthcare Research and Quality (AHRQ). (Codeword translation: Agency for Healthcare Procedures and Compliance)

AHRQ was named throughout the Recovery Act (2009 economic stimulus), both in the HITECH Act policy part of the bill, and the other economic stimulus funding parts of the bill. It is a member of the board of governors for the Patient-Centered Outcomes Research Institute (PCORI). (Codeword translation: Data-Centered Outcome Procedures Institute.) The billions of dollars in funding for guidelines and data operations go through AHRQ.

According to its own budget document, AHRQ is now one of three organizational focuses for the Department of Health and Human Services along with the National Institutes of Health and the Centers for Disease Control. ARHQ is one of the agencies behind the Nationwide Health Information Network.

The Patient Protection and Affordable Care Act takes things further.

Sticks

Policymakers have methods for handling physicians who do not embrace external control, specifically “linking payment to quality outcomes.” Title III of the Affordable Care Act on “improving the quality and efficiency of health care” shifts the line between incentives and penalties. Policies that were once optional and rewarded with incentives become mandatory with noncompliance punished.

Even getting paid for services rendered is subject to “pay for performance” under the authority of the “value-based payment modifier.” Whoever pays has control, and the Affordable Care Act takes control of payment.

There are other methods for ensuring physician compliance.

First, there is a physician’s public reputation. There is to be online public reporting of how compliant a physician is with government-prescribed “best practice” guidelines under the “Physician Quality Reporting System.”

Second, there is subjecting the determination of the physician to be in error. At the first National Summit on Medical Errors and Patient Safety Research in 2000, Robert F. Meenan, M.D., Dean of the Boston University School of Public Health, commented on treatment for chronic diseases saying, “Variations from these best practices should be defined as medical errors and their causes and corrections should be pursued.”193

Third, physicians are considered committing fraud for not complying with government-issued requirements. The Affordable Care Act increases penalties for fraud from $11,000 per item to $50,000 per item. Further, federal officials are authorized to “extrapolate” such errors across all the years of the doctor’s practice of medicine. This authority extends to private insurance.

One study has already found 39 percent of physicians falsifying insurance records to secure needed health care services for patients.59

These policies create the very misuse they were intended to eliminate.

Access to patient data could also extend to control over patients after the patient has left the physician. Pharmacies with patient data and clinical protocols could be able to dose escalate, dose change, and therapy change based on those protocols.37

Sabine Kleinert, an executive editor at The Lancet in Oxford, England, asserts, “In the search for objectivity and firm guidelines the field of evidence-based medicine has quickly advanced to evidence-based decisionmaking and evidence-based rationing.”119 Decisionmaking by guideline, including guidelines that exclude innovative or costly treatments, allows the government to “avoid direct responsibility for making uncomfortable and politically sensitive rationing decisions.”118

In the name of “scientifically depoliticizing the rationing debate,”142 “guidelines” and “best practices” provide political cover for denying unproven (innovative) and costly treatments. This is the conclusion of practice guidelines applied to electronic patient records.

Clinical Case Management

The monitoring of medical activity is not limited to professionals in the medical community.

In the name of public health and allocation of public resources, in 2006, the New York Department of Health and Mental Hygiene created a “registry” of all diabetics, electronically reporting their hemoglobin results and personal information without consent and without an ability to opt out. This was the first of its kind for a noncommunicable disease.

The government determined it knew better than medical professionals and patients claiming, “[P]rimary care clinicians are not in a position to understand why only 30% of patients with hypertension are achieving their target blood pressure or why only 7% of diagnosed patients with diabetes are on target for all 3 major clinical outcomes (blood glucose, blood pressure, and cholesterol values).” It sent letters to people who had what it considered high HbA1c scores.

Others described it as “a governmental database of identified diabetic patients who are in poor glycemic control.” Either way, this kind of clinical case management involves “intense monitoring of adherence” to guidelines by patients with repeated contacts and reminders.

Chicago Lives Healthy is a prime example of a public health “wellness” program 2012-style.

Who needs to offer a service worth its price when you can charge them for not participating in your program? “By participating, you will avoid a $50 per non-participant increase in your monthly employee health care contribution.” If you decide not to participate, then they will take your money and give it to someone else: “The $50 per non-participant increase in your monthly employee health care contribution is used to provide wellness services and benefits for our eligible employees and covered spouses/domestic partners.”

“Every part of the Chicago Lives Healthy wellness program is free to all eligible employees and their covered spouses/domestic partners who chose to participate.” Those “free” benefits include required annual biometric screenings, required annual Well-Being Assessments™ (WBA), a required Health Check-In Call, Health Coaching Calls, and required wellness activities every month.

This program is neither “free” of cost, nor is one free to decline these “free benefits” under this program. How long will it be before Chicago has identified diabetic patients who are in poor glycemic control?

The Agency for Healthcare Research and Quality has a Comprehensive Wellness Program and Worksite Wellness Toolkit “for businesses and organizations to begin or expand worksite wellness programs. Businesses of all sizes and types can use the guide. It provides information on a simple step-by-step planning process for establishing a worksite wellness program.” We’ve already seen how optional “guides” become.

National Strategy

President Obama’s original selection for Secretary of Health and Human Services was Former Senate Majority Leader Tom Daschle. In February 2008, Daschle published Critical: What We Can Do About the Health-Care Crisis, a book on “Undoubtedly, the biggest domestic policy issue in the coming years ... America’s health-care system.”

According to the publisher, “Daschle’s solution lies in the Federal Reserve Board, which has overseen the equally complicated financial system with great success. A Fed-like health board would offer a public framework within which a private health-care system can operate more effectively and efficiently—insulated from political pressure yet accountable to elected officials and the American people. Daschle argues that this independent board would create a single standard of care and exert tremendous influence on every other provider and payer, even those in the private sector.”

Of course, we have seen the shape this “independent board” has taken, and how it is indeed “insulated from political pressure.”

The other comment about the Federal Reserve is also instructive. Uwe Reinhardt, Ph.D., a noted economist and professor at Princeton University, has cautioned, “My fear is that medicine will slide into the same intellectual morass in which economists now wallow, often with politics practiced in the guise of science. In medicine, it might be profit-maximizing in the guise of science.”74

All federal agencies need annual funding to operate. The 2013 Labor, Health and Human Services appropriations bill contained its share of controversies, and the Agency for Healthcare Research and Quality was not among them in the first cut for reporting from one Capitol Hill news organization. By that night, an interest group sent an alert and the news made the second cut. Chairman Denny Rehberg (R-Mont.) had terminated AHRQ altogether.

This is chemotherapy America needs to keep the health care system cancer from spreading.


This paper uses content freely, with permission, from two papers by the Citizens’ Council for Health Freedom. Footnote numbers in standard type refer to footnotes in “How Technocrats are Taking Over the Practice of Medicine,” January 2005, and footnote numbers in italics refer to “‘Evidence-Based Medicine’: Rationing Care, Hurting Patients,” December 2008.

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