Transforming Clinical Practice Guidelines Into Legislative Mandates: Title and subTitle BreakProceed With Abundant Caution

Clinical practice guidelines (CPGs) are an integral part of medical practice and an important quality-of-care indicator. Because CPGs offer the promise of more consistent and effective health care,¹ policy makers should promote their development and use. Except in rare instances, however, support should not be transformed into legislative mandates, as was recently considered in Texas.

In July 2006, an independent group of cardiologists published the Screening for Heart Attack Prevention and Education (SHAPE) Task Force Report.² The group recommended screening of all asymptomatic men aged 45 to 75 years and women aged 55 to 75 years (except those defined as very low risk) for subclinical atherosclerosis.² Based on this controversial proposal, Texas Rep Rene Oliveira introduced legislation on February 14, 2007, to mandate that health insurers in Texas provide reimbursement for screening to detect asymptomatic atherosclerosis.³

Although the legislation was not enacted, it reportedly will be reintroduced in 2008 (J.J. Garza, Chief of Staff to Rep Oliveira, written communication, December 10, 2007). Regardless of whether this particular mandate is enacted, physicians and patients have reason to be concerned about its implications. The legislation is bad public policy—for physicians, patients, and evidence-based medicine—and should be opposed.

Since the conditions motivating similar legislation remain in place, it seems highly likely that the Texas legislation will not be an isolated event. The conditions include increasing entrepreneurial activity among physician specialty groups; using legislation to pursue narrow clinical and financial objectives; fast-moving technological advances in areas such as cardiology; the proliferation and fragmentation in guidelines development; and increasing pressure on legislators to mandate access to new technologies. Closer examination of the SHAPE guidelines demonstrates why this episode is likely to be replicated.

Developing diagnostic tools to identify the risk of coronary heart disease (CHD), the leading cause of mortality for US men and women, is a major clinical and public health objective.⁴ If disease is detected early, clinical or behavioral interventions may reduce harm or extend life. Indeed, more aggressive CHD screening strategies could motivate patients to change their behavior. Yet the evidence from early screening is mixed. For example, while colon cancer screening has been highly successful at reducing mortality, evidence is not convincing that screening reduces mortality from prostate cancer.⁵ Screening also yields false-positive results, leading to unnecessary procedures that can cause harm.⁶ Especially where the link between screening and better outcomes is uncertain, as with CHD, the costs of population-based screening can be substantial.

The current screening recommendations for detecting susceptibility to atherosclerosis among asymptomatic adults consist of assessment and risk stratification derived from the Framingham Risk Score. For patients with a score greater than 20%, aggressive intervention is appropriate; for those with a score less than 10%, lifestyle changes may be sufficient.⁷ For those with an intermediate score of 10% to 20%, further screening tests, including ultrasound for measurement of carotid intima-media thickness (CIMT), electron-beam computed tomography (EBCT), and exercise treadmill tests, can determine the need for specific therapeutic interventions.

There is no agreement regarding which screening tests are most effective for the intermediate-risk group or whether screening improves health. In 2000, the American College of Cardiology (ACC) and the American Heart Association (AHA) concluded that EBCT is not superior to alternative noninvasive diagnostic techniques and has a high rate of false-positive results.⁸ In 2004, the US Preventive Services Task Force (USPSTF) “found insufficient evidence to recommend for or against routine screening with . . . EBCT. . . . ”⁹ A 2007 ACC/AHA statement is tentatively favorable toward EBCT for patients at intermediate risk but does not support widespread screening.¹⁰ Currently, the National Institutes of Health is sponsoring prospective studies to understand how well EBCT predicts events.¹¹

A group of cardiovascular specialists, apparently dissatisfied with current screening practices, issued the SHAPE Task Force Report. Sponsored by the Association for Eradication of Heart Attack, an independent group of cardiologists located in Houston, Texas, the report proposes a “new practice guideline for cardiovascular screening in the asymptomatic at-risk population.”² Without recommending a particular test, the report takes an aggressive position suggesting that the guidelines, if adopted nationally, would prevent 90 000 deaths and save $21.5 billion annually.

Despite these predictions, there is no scientific evidence that the benefits of widely adopting the SHAPE guidelines outweigh the harms.⁷ For one thing, there is no indication that the guidelines have been either peer-reviewed or endorsed by the ACC, the AHA, or the European Society of Cardiology. Although many prominent cardiologists participated on the SHAPE Task Force, the absence of a broader professional consensus raises questions about the SHAPE guidelines' credibility and breadth of acceptance among cardiologists.¹² For another, the appearance of conflict of interest further limits the guidelines' credibility. These guidelines were published as a supplement to the American Journal of Cardiology with the following statement: “Publication of this supplement was supported by Pfizer, Inc.”

Representative Oliveira's bill (HB 1438) adopts the SHAPE Task Force's screening recommendations without considering their limitations. The bill specifically mandates insurance coverage up to $200 every 5 years for EBCT or measurement of CIMT. According to Representative Oliveira, the motivation for the legislation is to extend “the lives of those who can afford the procedure while hundreds of thousands of cases of heart disease go undetected because of antiquated thinking.”³

Well-designed CPGs are an essential component of EBM. Optimal guidelines are flexible instruments that are based on the best available scientific and clinical information, represent professional consensus (including support from medical professional societies), and allow physicians to exercise individual judgment in treating patients. To ensure credibility, the process, reasoning, and methods must be transparent (ie, include full disclosure of potential financial or other conflicts of interest) and subjected to rigorous scientific analysis (ie, peer review).¹³

By contrast, legislative mandates tied to specific technologies or treatments are inflexible, static, and not as easily changed as science advances. Once enacted, the mandated guideline effectively crowds out alternative approaches and the deliberative medical consensus process. For instance, the Texas mandate specifically favors EBCT and measurement of CIMT over exercise treadmill tests, creating a disincentive to use and learn from other screening mechanisms.¹⁴

Mandates may thus support the premature diffusion of unproven technologies. An example is the use of high-dose chemotherapy with autologous bone marrow transplantation (ABMT). Despite the absence of scientific evidence supporting the procedure relative to conventional therapies, the Minnesota legislature (among other states and the Federal Office of Personnel Management) mandated insurance coverage for ABMT in 1995. In 2002, attempts to repeal the Minnesota ABMT mandate failed, even with additional evidence undeniably showing no clinical benefit.¹⁵

Likewise, evolving evidence for the relationship between postmenopausal hormone therapy and CHD supports the need for legislatures to proceed cautiously. Massachusetts mandated coverage of hormone therapy in 2002.¹⁶ Despite new evidence^{17 - 18} that clarifies the efficacy and appropriate use of hormone therapy for avoiding increased risk of myocardial infarction or stroke,¹⁹ the broad Massachusetts insurance mandate remains in effect.

Mandates are not inherently misguided; arguably, mandates are less intrusive to clinicians than insurance coverage decisions. However, it seems unrealistic to think that mandates do not affect medical practice, as no doubt occurred with ABMT. Therefore, the case for a mandate must be compelling before displacing physician discretion.

First, does sound science, such as randomized controlled trials or USPSTF recommendations, support a mandate? Unless the evidence is sufficient that mandating the procedure will improve patient care at a reasonable cost-effectiveness ratio, the mandate should not be supported.²⁰

Second, what are the clinical implications? Given the multiplicity of guidelines, legislators should rely on national medical professional society guidelines as a strong indicator that the mandate reflects a reasonable professional consensus. For example, the lack of professional agreement regarding screening of prostate-specific antigen levels to detect prostate cancer should discourage legislators from mandating that test.²¹

Third, who is advocating for the mandate, and what interests are at stake? Before enacting a mandate, procedures must be implemented to identify and resolve potential conflicts of interest. This is paramount when physicians might have a direct financial stake in the legislative outcome.

Fourth, what are the potential costs and risks of the mandated procedure or treatment? Because screening tests may result in false-positive results, which can lead to anticipated harms from more invasive procedures, the USPSTF could not determine the balance between benefits and risks of CHD screening for the intermediate-risk population.⁹ As a result, any legislation imposing mandates should require tracking the outcomes from the policy change.

On each of these dimensions, the case for the proposed Texas legislation is weak. The scientific evidence supporting the screening mandate remains tenuous, as the lack of reasonable medical professional consensus indicates. Imposing this mandate would ensure the premature diffusion of a technology that limits physician autonomy and codifies particular screening approaches.

Even though the proposed Texas legislation is not the first controversial procedure to be mandated, it is a particularly unwelcome extension of lawmakers practicing medicine. Adopting the proposed Texas legislation would encourage other states to consider ever more expansive mandates, particularly if a legislator has a personal experience motivating the proposed mandate. For example, supporters of full body scans could issue their own CPGs and find a sympathetic state legislator to introduce an insurance mandate, despite the lack of scientific support.

The SHAPE guidelines and resulting Texas legislation have significant implications for medical organizations and professional societies. This is not only an issue for cardiologists—it affects the entire medical profession. The problem occurs when prominent members of a medical society develop guidelines or policies that do not reflect or that perhaps conflict with medical professional consensus. DeMaria has used the term “populism” to characterize similar guideline development efforts of independent groups.¹²

Increased entrepreneurial activity is likely in a less regulated, consumer-directed health care era. In fact, the SHAPE guidelines represent a strain of entrepreneurial medicine that is important for pushing the boundaries of what is clinically possible and for developing innovative clinical strategies to improve both individual treatment and population health. Competition among clinicians to determine the best clinical practices is desirable. The challenge is to ensure that guidelines resulting from entrepreneurial activity take professional consensus into account and avoid potential conflicts of interest.

As with the ABMT example, the Texas mandate would endorse entrepreneurial activity without adequate input from major medical organizations. To forestall that result and a cascade of similar efforts, medical organizations should take the following steps.

First, national professional medical societies and organizations should work with their local affiliates in Texas to oppose the mandate when it is reintroduced in the legislature. Physician involvement in minimizing legislative intrusion into medical practice is a necessary counterweight to legislation that might otherwise ignore important clinical considerations.

Second, the ACC, as the appropriate specialty society (perhaps in conjunction with the AHA), should convene a consensus conference to determine the objectivity and scientific efficacy of the SHAPE guidelines. This is not to argue that professional societies should retain a monopoly on guidelines, nor is it to discourage entrepreneurial activity. Instead, given the likelihood of increasing entrepreneurial pursuits, broader medical professional consensus is needed to avoid the diffusion of procedures that do not meet acceptable clinical criteria.

Third, medical organizations should design effective processes for evaluating clinical procedures before their widespread diffusion. Organized medicine should develop criteria to determine what constitutes an acceptable CPG and then evaluate new guidelines against those criteria. Only those guidelines that meet the criteria should be endorsed. The results of the evaluation should be widely distributed to physicians and communicated to the public.

Robust professional debate over the interpretation of ambiguous or limited scientific evidence is preferable to legislative mandates that disrupt the scientific process and foreclose alternative options. Over time, further debate and new evidence may yield optimal screening guidance. In the interim, physicians can weigh the SHAPE guidelines relative to other clinical evidence for treating individual patients. To ensure that the Texas legislation is an isolated event rather than the leading edge of transforming CPGs into mandates, the medical community should encourage legislators to proceed with abundant caution.