Evidence is said to be the new bright star of health care. A growing chorus of voices is thus calling for physicians and other health care practitioners to follow evidence-based medicine (EBM), or so-called “best practices.” To practice EBM, supporters say physicians must follow evidence-based clinical practice guidelines.
Despite being painted as scientifically sound, there are more than a few detractors of EBM, including physicians, patients, and researchers. Even those who sup-port evidence-based medicine and practice guidelines worry about how it may play out in real-life patient care.
This paper will introduce the concepts, note the assertions of supporters, highlight the concerns of critics, question the emphasis on evidence and clinical guide-lines for the practice of medicine, identify the costs of guidelines, and show how EBM is making its way into state and federal laws, including medical malpractice reform initiatives. A word about terminology: this re-port uses “guidelines,” “best practices,” “ algorithms,” and “protocols” interchangeably.
Clinical practice guidelines are the embodiment of evidence-based medicine.1 Managed care organizations began developing guidelines in the 1990s to identify inappropriate medical care and reduce unnecessary utilization of services.2 More recently, state and federal policy makers have incorporated “best practices” or evidence-based guidelines in legislative proposals aimed at health care cost containment and medical malpractice reform.3
Practice guidelines “specify the processes of diagnosing and treating particular conditions.” 4 Or as defined by the Institute of Medicine (IOM), the federally-funded organization providing the U.S. Congress with health care policy research, “evidence-based guidelines” are:
Consensus approaches for handling recurring health management problems aimed at reducing practice variability and improving health outcomes. Guideline development emphasizes using clear evidence from the existing literature, rather than expert opinion alone, as the basis for advisory materials.5
Proponents of EBM argue that “there are no systems in place for ensuring that best practices are consistently implemented.” 6 They claim that physician compliance with guidelines—essentially, practice directives—will reduce “overuse,” “underuse,” and “misuse” of health care services7 8 9 (considered by IOM to be the primary quality problems in American health care today 10 ).
Moreover, some claim that “although we perceive the U.S. health care system as superior, there are serious and widespread quality problems. There is a gulf between ideal care and what actually takes place.”11 Others point to the 2003 RAND study reported by Elizabeth McGlynn et al., which concludes, “Americans receive about half of recommended medical care processes.”12 However, most EBM advocates do not mention the study’s limitations. Earl P. Stinberg, M.D. says the RAND study does not mean adults have only 50 percent chance of getting adequate care. He notes poor documentation in the medical charts used, and a focus on compliance with management recommendations—essentially, guidelines—rather than on how well the patient’s medical conditions were actually controlled.13
Evidence-based medicine advocates also claim that guideline adherence will protect physicians from malpractice litigation, limit variation in physician practice patterns, and improve quality of care. In addition, advocates believe adherence will cut costs by reducing the practice of “defensive medicine”—which is described by the U.S. Office of Technology Assessment as the ordering by physicians of “tests and procedures, or avoidance of high risk patients or procedures, primarily (but not necessarily solely) to reduce their exposure to malpractice risk.”14
Compliance with treatment directives, rather than the practitioner’s opinion, gut instinct, or clinical experience is preferred by some EBM proponents.15 16 Using “evidence” to direct treatment decisions is emphasized, as former U.S. Senator David Durenberger, now CEO and Chair of the National Institute of Health Policy, makes clear when he instructs patients:
Ask your health care providers about how they make care decisions. Are they using clinical evidence-based guidelines to determine the treatment? Are the clinical outcomes as expected? High-quality clinical decisions come from ‘gold standard’ evidence—education, training, practice and organizational guidelines built on a culture of quality.17
It would be difficult to find a physician opposed to “high-quality clinical decisions,” but not all doctors support standardized treatment protocols or so-called “best practices.” Thus, although the IOM endorses clinical practice guidelines (CPGs) saying they “aim to change clinical practice to make it more consistent around a definition of best practice,”18 others view such guidelines as a “cookbook” for patient care.19
According to Professor Arnold Rosoff, J.D., at the University of Pennsylvania,
Some decry the spread of CPGs as the advent of “cookbook medicine,” having the potential to turn doctors into automatons and lower the quality of health care by subordinating and subverting professional skill and judgment. 20
Some physicians view EBM—and its associated treatment directives—as a fancy term for imposing rigid standards of care, cutting costs, and restricting professional freedom and judgment.21 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 de-fine ‘best practice,’” yet retain no responsibility for the clinical consequences.22
Moreover, physicians may disagree on what constitutes “best practice.”23 According to Woolf et al., the view of practice guidelines depends on who is doing the evaluation:
[A]ttitudes about whether clinical guidelines are good or bad for medicine vary from one group to another. Guidelines produced by governments or payers to control spiraling costs may constitute responsible public policy but may be resented by clinicians and patients as an invasion of personal autonomy. Guidelines developed by specialists may seem self-seing, biased, and threatening to generalists. To specialists, guidelines developed without their input do not contain adequate expertise. Inflexible guidelines with rigid rules about what is appropriate are popular with managers, quality auditors, and lawyers but are decried as ‘cookbook medicine’ by doctors faced with non-uniform clinical problems and as invalid by those who cite the lack of supporting data.24
Practice Guidelines – HMOs
In the private sector, HMOs and other health plans strongly support the development and use of clinical practice guidelines. For example, six managed care organizations fund the Institute for Clinical Systems Improvement, a major guideline development organization.25
Alan Muney, M.D., from Oxford Health Plans, clarified the importance of clinical guidelines to managed care plans. At a 1999 medical education conference, he said the “second generation of managed care” will focus on using evidence-based medicine as a method to identify and control clinical practice outliers26 —those physicians who practice outside prescribed guide-lines. In fact, some managed care organizations may prefer that physicians be trained early to follow these treatment protocols. As Dr. Muney explained,
The purpose of such a program [evidence-based education] is to drive lifelong adherence to clinical practice guidelines resulting in improvement in the value of healthcare expenditures. The target audience is medical students, interns, and residents.27
Most physicians, but likely few patients, know that practice guidelines are already a prominent feature of HMOs and managed care. In fact, managed care organizations often claim a strong evidence base for the practice guidelines and treatment algorithms they give physicians to follow. As Uwe Reinhardt, Ph.D., a noted economist and professor at Princeton University, says:
EBM is the sine qua non of managed care, the whole foundation of it.28
Guidelines – A Public Sector Example
The push to require physician adherence to treatment protocols has advanced across the country as state bud-gets are increasingly squeezed by the high cost of pub-lic health care programs. Some administrators and government officials claim treatment guidelines can not only cut costs in Medicaid, but improve care.29 For ex-ample, Minnesota Governor Tim Pawlenty, in his 2004 State of the State address, said his administration’s approach to health care will include,
…leveraging the purchasing power of the state and other partners to force health care providers to use best practices and deliver higher quality results.30
Although Governor Pawlenty’s plan did not sit well with the public—a stack of citizen and physician petitions more than 12-inches high was delivered to his office—the Governor signed the “best practices” bill into law on May 29, 2004.31 The new law authorizes government-issued “best practices” guidelines, government data collection, and public reporting of physician adherence to government-defined “best practices.” It also permits contractually-based financial penalties for health plans whose physician-employees and physician networks do not adhere to “best practices” guidelines in the treatment of state employees and recipients of government health care programs, such as Medicaid.
Shortly after the bill was signed, Minnesota Physician published an interview with the governor. Although Governor Pawlenty stated his opposition to government micromanagement of treatment decisions, his comments seem to advocate an implicit version of it:
I don’t think we want government micromanaging health care or presenting the government-sanctioned cookbook on how physicians should practice. I’m not interested in that. What I am interested in is using higher rates of reimbursement or premium reimbursement rates if providers achieve certain out-comes, better outcomes.32
No details were provided regarding how the terms “certain outcomes” or “better outcomes” would be defined—or payment decisions made. But the intent appears to include financial rewards for health plans who can coax or coerce physician performance matching a yet undefined list of government treatment stipulations which may or may not coincide with patient needs or preferences.
Attack on Autonomy
Practice guidelines can be “a mechanism for nonclinicians to use in controlling clinicians.”33 David M. Eddy, M.D., Ph.D., notes that the use of practice guidelines as management tools “puts a mechanism designed for internal use in the hands of ‘outsiders,’ such as utilization reviewers, the government, and insurers. Not only does this expose internal thoughts to external scrutiny, it opens those thoughts to manipulation.” 34 He further cautions,
It is not stretching things too far to say that whoever controls practice policies controls medicine.35
Control over practice policies does not appear to be headed in the direction of physicians or patients. David Plocher, vice president of health consulting for Cap Gemini Ernst & Young, predicts that the future of total population management (TPM) will include ensuring physician use of evidence-based medicine, financial incentives for patient compliance, developing methods to measure outcomes, and rewarding doctors for adherence to guidelines.36
Another suggested use of guidelines could eventually lead to reduced patient access to physician care. At a roundtable discussion on diabetes, Gary Rice, M.S., Di-rector of Pharmacy and Retail Services at Texas-based Kelsey-Seybold Clinic, discussed his company’s plan:
With this data warehouse [of 7,000 patients], our goal is to get the physicians to allow the pharmacist to gain access to that data and to allow the pharmacist, through clinical protocols and pathways, to be able to dose escalate, dose change, and therapy change based on those protocols.37
Convincing physicians to leave their professional autonomy and responsibilities behind requires a certain array of tools, including financial incentives. A project by the American College of Cardiology (ACC) sought to “better understand what factors led to more rapid and complete alignment of practice with the recommendations in the guideline.”38 The ACC project found that adherence to guidelines was improved when “critical recommendations are embedded in the practice environment,” including reminders on key performance goals for clinicians.39 The study’s authors note,
[A]pplying those guidelines in practice requires systems to structure the environment in which care is delivered so that ‘doing the right thing’ becomes automatic. This requires tools that simplify and provide focus by embedding the recommendations for evidence-based care into the care itself…Achieving this—that is, changing and aligning the behavior of clinicians and managers—is no small accomplishment…Clearly, appropriate financial incentives and regulatory stimuli can play a role. Doing what is ‘right’ is more likely to occur when knowledge, systems, and incentives are aligned.40
Payment for doing what is dubbed “right” does not sit well with some physicians who take umbrage with the very idea of such “pay for performance” proposals. Roy B. Verdery, Ph.D., M.D., responded to an article published in The New England Journal of Medicine titled “Paying Physicians for High-Quality Care.” He wrote,
Epstein et al. would have us conform to static norms and care for uniform patients, with money as our primary reward. We would pre-scribe only the “right” drugs, use only the “best” techniques, and implant only the “best” devices, as determined by formularies, pundits, and industry-sponsored studies…Economic incentives are always subject to “gaming,” in-appropriate manipulation of data, and “cherry-picking” of patients by physicians and groups more interested in making money than in pro-viding good care. Most physicians (and other professionals) work for rewards that are more important than money, including the respect of their patients and peers and the personal satis-faction of a job well done.41
Dr. Verdery has legitimate cause for concern. It appears that the treatment of patients outside guideline specifi-cations is already considered a “violation” —in other words, wrong—by one consortium of large employers, The Leapfrog Group. In November of 2003, members of the American Medical Association received a presentation from a representative of the group. Their proposals for physician offices included, “Generation of periodic reports of guideline-adherence rates for the physician office’s patient population as a whole,” and “Flagging (and documented override) of clinical guide-line violations.” 42
That practice guidelines may restrict patient care and physician autonomy does not bother one physician re-searcher. Dr. Marshall de Graffenried Ruffin, Jr. in The Physician Executive, writes, “Evidence-based medicine can be seen as an acceptable, even necessary, limitation of clinical freedom, because it leads to practice guidelines meant to standardize and reduce the variation in clinical care.” 43
However, variation in care does not necessarily equate with bad medical practice. Gary Belkin, M.D., Ph.D., writing from Harvard University, asserts, “Very respect-able and productive medical traditions found variations natural and expected.” He also notes that variation was “not a problem discovered,” but instead came to be considered a problem when cost control through standardization became a goal of researchers and HMOs.44
Shifting Control through “Science”
Dr. Belkin is author of one of the most comprehensive papers on the motivation and philosophy behind the new focus on scientific evidence in medicine. He says EBM is not purely about so-called “good science,” but about the destructive industrialization of medicine by those who want to control it.45
In “The Technocratic Wish: Making Sense and Finding Power in the ‘Managed’ Medical Marketplace,” Belkin writes, “we need to explain how a given version of scientific credibility is embraced to sustain influence and power in society.” 46
Dr. Belkin argues that analyzing patient data, measuring physician performance, and calling the process “scientific” is the mechanism being used today to shift power and control away from physicians—and under-mine 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.47
Arnold Rosoff, speaking at a workshop sponsored by the Agency for Healthcare Research and Quality (AHRQ) and the Institution of Medicine in April 2000, says the following in reference to Belkin’s paper:
In the arena of managed care, the technocratic wish takes the form of a search for a (seemingly, at least) objective and verifiable rationale to justify the shift of control from an en-trenched medical elite to a new cadre of health services researchers, MCO [managed care organization] executives, and government policy makers. 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 popuation-based rather than individual-based measures to assess the utility and cost-effectiveness of health care inputs.
To put it another way, the technocrats tend to measure the success of health care activities by looking at their aggregate effect on populations rather than on individual patients, contrary to the clinician’s natural tendency to focus on the individual patient she or he is currently treating.
To implement their health care philosophy, those who share the technocratic wish collect data from entire populations, crunch the numbers, and express their conclusions as to what works best in terms of population-wide statistics.
…In Belkin’s view, managed care has em-braced the technocratic wish in its desire to find a rationale and a mechanism for standardizing medical practice and reining in physicians’ natural inclination to treat each patient as a special case.48