In an article in JAMA on how to slow health care spending, noted Harvard health economist David Cutler states that a "major direction" for health care reform is "to ensure that physicians who adhere to guideline standards know that lawsuits based on providing that care will be rapidly dismissed."(1) The notion that medical practice guidelines should be conclusively presumed to establish the legal standard of care for physicians, referred to as a "safe harbor" approach, is not new; some states experimented with it in the early 1990s, bills to effectuate various versions of it have been introduced repeatedly in Congress, and President Obama supported the idea in return for obtaining the support of the American Medical Association for the Affordable Care Act.

The experiments in the 1990s all failed, however, as none of the bills introduced in Congress has come close to passing, and President Obama's effort, embodied in the planning-and-demonstration grant program of the Agency for Health Research and Quality (AHRQ), has so far come to naught. Why has the safe harbor idea not succeeded, and what are the prospects for its successful adoption in the future?

Historical Context

The legal standard of care for medicine in the U.S. typically is determined by judges and juries based on the opinions of medical experts about what is customary or reasonable practice in similar cases. The experts often support their opinions by citing what they deem to be authoritative sources, including medical treatises, scholarly publications, and medical practice guidelines, that is, practice recommendations issued by various professional groups. But in malpractice disputes, the experts typically disagree, leaving it up to lay judges and jurors to decide which experts' opinions are correct.

The lack of medical expertise on the part of judges and juries, coupled with dislike of the malpractice system in general and alarm at periodic "crises" characterized by sudden, steep increases in malpractice insurance premiums, has prompted the medical profession over the years to try to assert greater control over how the law establishes the standard of care. One effort has been to get legislatures to pass laws requiring courts to accept medical practice guidelines as definitive statements of the legal standard of care, so that physicians who followed guidelines could not be found liable for poor patient outcomes. This approach currently is called "safe harbors."

The first attempt to adopt a safe harbor approach took place in Maine in 1990, when the state legislature authorized the state medical societies of anesthesiologists, emergency physicians and OB/GYNs to produce practice guidelines that physicians could use as defenses in malpractice cases. (Radiologists were added a year later.) A notable feature of the legislation was that the guidelines could only be used as a defense to liability; plaintiffs could not introduce a failure to follow the guidelines as evidence of wrongdoing. The specialty groups apparently did create guidelines, but due to a quirk in Maine's malpractice law, it turned out that, in some instances, plaintiffs could in fact introduce a failure to follow a guideline as evidence of malpractice, and the only way to prevent this was for the physician defendant to refrain from relying on a guideline as a defense; accordingly, only once during the 11-year life of the program did a physician assert a safe harbor defense.

Another problem with the Maine law was that the guidelines were not absolute defenses, since plaintiffs could still seek to prove that the physician did not follow the guideline or that the guideline did not apply to the case in question. While three other states initially sought to emulate Maine's effort, Republicans in Congress introduced bills to create safe harbor programs at the federal level, and President Clinton included a pilot program in his health reform legislation, none of these came to fruition. A major reason was the poor quality of guidelines available at the time.(2)

The safe harbor idea remained largely dormant until 2009, when President Obama discussed it with the AMA to help gain the organization's support for his health reform initiative. In 2010, the Agency for Healthcare Research and Quality (AHRQ) awarded a planning grant under the Affordable Care Act to Oregon to develop a safe harbor program for the state. After exploring the idea with stakeholder groups, the Oregon planners decided that practice guidelines could better be used to improve the quality of care rather than to establish the legal standard of care; one of their findings was a high level of concern among physicians that "gaining consensus and implementing uniform guidelines would be challenging."(3)

Two bills that would establish safe harbors were introduced in Congress in 2015. Rep. David Roe (R-TN) sponsored HR 2653, while Rep. Tom Price (R-GA) introduced HR 2300.(4) Though the bills differ in important respects, both would authorize the Secretary of Health and Human Services to enable guidelines to establish the legal standard of care, create medical panels to review claims by physicians that they followed the guidelines, and make it extremely difficult for plaintiffs to prevail if the review panel accepted the physician's claim. While neither of the bills may be enacted, they give an idea of what policy-makers who favor safe harbors have in mind.

Challenges

As mentioned earlier, previous attempts to adopt a safe harbor approach were unsuccessful due to problems associated with creating guidelines and implementing their use as malpractice defenses. To what extent would these and similar challenges hamper the adoption of safe harbors?

As mentioned earlier, one reason why earlier safe harbor initiatives failed was the poor quality of the guidelines available at the time. A major shortcoming was the lack of sound scientific evidence to support them. Proponents of safe harbors are hopeful that the current push for "evidence-based medicine," given momentum by federal funding for comparative effectiveness research, will yield data upon which scientifically-sound guidelines can be based.

HR 2653 provides standards for guidelines, including that, to the "extent practicable," they be "guided by" recommendations issued by the Institute of Medicine in 2011, which emphasize the need for careful review of the available data and transparency concerning its strength. HR 2300 merely authorizes HHS to contract with a "qualified consensus-building organization such as the [AMA] Physician Consortium for Performance Improvement" to develop guidelines "in concert" with physician specialty organizations. The vagueness of these provisions leaves open the possibility that guidelines serving as safe harbors may be based on inadequate or poor evidence.

There even are questions about what would make a guideline "evidence-based" and what should count as evidence. A 2007 article in JAMA, for instance, stated that "there is ambiguity about what 'evidence based' really means in the context of guidelines. The term may be interpreted differently depending on who is referring to the guideline — the developer, who creates the guidelines, or the clinician, who uses them. To their developers, 'evidence-based guidelines' are defined as those that incorporate a systematic search for evidence, explicitly evaluate the quality of that evidence, and then espouse recommendations based on the best available evidence, even when that evidence is not high quality. However, to clinicians, 'evidence based' is frequently misinterpreted as meaning that the recommendations are based solely on high-quality evidence (i.e., randomized clinical trials [RCTs])."(5) It remains to be seen how well current efforts to identify evidence-based practices will generate guidelines backed by adequate scientific support.

New scientific knowledge requires that guidelines be kept up to date. HR 2300 requires HHS to review guidelines within four years after it becomes law and every two years thereafter; HR 2653 only requires HHS review every five years unless an organization issuing guidelines submits amendments to the agency. As a result, safe harbor guidelines may not be based on the latest knowledge.

A major concern about the quality of guidelines is whether they reflect conflicts of interest or other biases on the part of the experts who create them. A 2011 study of the 17 cardiovascular MPGs issued by the American College of Cardiology and the American Heart Association, for example, reported that 56 percent of the 498 individuals who participated in the process of creating the guidelines had financial conflicts of interest, most often from serving as an industry consultant or advisory board member but also from receiving research grants and honoraria or from outright stock ownership or other investment interests.(6)

In addition to financial conflicts, professional biases can influence the recommendations reflected in guidelines. A 2010 study, for example, found that the treatment received by prostate cancer patients varied depending on whether they were seen by urologists or radiation oncologists, rather than on the patient's characteristics or preferences, with the former more often recommending surgery and the latter preferring radiation therapy.(7) One, therefore, might expect to see differences in prostate cancer treatment guidelines depending on which specialty group issued them.

The IOM recommends that persons who develop guidelines disclose conflicts of interest and, if they cannot be avoided completely, that at least a majority of the developers and the chairs be free of them. The IOM also recommends that the development group be "multidisciplinary and balanced," and that proposed guidelines be externally reviewed "by a full spectrum of relevant stakeholders."

HR 2653 merely requires that conflicts be disclosed, while HR 2300 does not address the issue at all.

There is no single source of practice guidelines that is universally recognized as authoritative. This raises the question of whose guidelines will be deemed to establish the legal standard of care in specific cases. Even guidelines issued directly by the federal government, such as recommendations for vaccinations from the Centers for Disease Control and Prevention (CDC), can be met with skepticism from some practitioners. AHRQ maintains the National Guideline Clearinghouse (NGC), a database containing more than 2,400 guidelines issued by more than 300 organizations, including professional groups such as specialty societies and colleges; the federal government (e.g., the CDC); quasi-governmental entities such as the U.S. Preventive Services Task Force; private health insurers; and hospitals. AHRQ emphasizes that it makes "no warranties concerning the content or clinical efficacy of the clinical practice guidelines and related materials" and that "inclusion of any guideline in NGC does not constitute or imply an endorsement by AHRQ."

Both bills introduced in Congress essentially make the government the "authoritative source" for safe harbor guidelines. HR 2300, as mentioned earlier, authorizes HHS to contract with a "qualified consensus-building organization such as the [AMA] Physician Consortium for Performance Improvement" to develop guidelines "in concert" with physician specialty organizations, and restricts safe harbors to only those guidelines. Presumably, then, the organization selected by HHS would be the single authoritative source for all safe harbor guidelines. HR 2653 gives "eligible professional organizations that have established, maintained, and updated [guidelines] on a regular basis..., including when applicable, appropriate use criteria, that incorporate best practices" six months to submit their guidelines to HHS; HHS then has six months to select one or more of these organizations "to provide and maintain such clinical practice guidelines on behalf of the Secretary [of HHS]." Yet physicians in the past have expressed concern that guidelines issued or vetted by the government, as opposed to solely by medical professionals, could impose political agendas on the practice of medicine or be used as a means of controlling costs rather than improving quality.

In the absence of a single authoritative source for practice guidelines, more than one organization can issue guidelines on the same topic, and given differences in focus and approach, the resulting guidelines can disagree about what constitutes appropriate care. The American Cancer Society, for example, notes that "many [of the more than 180] cancer screening guidelines [in the National Guidelines Clearinghouse database] differ, even when purported to have been based on the same set of evidence. Those difference cast doubt on the credibility of both the recommendations and the organizations that produced them."(8)

One source of information about conflicting guidelines is a set of approximately 30 "guideline syntheses" prepared by the ECRI Institute, the health services research organization that operates the National Guideline Clearinghouse.(9) These syntheses, which are available on the clearinghouse website, identify areas of agreement and disagreement among guidelines on the same subject and compare their methodologies, supporting evidence, funding sources, potential benefits and harms of following their recommendations, and the circumstances in which the guidelines say they should be disregarded. Syntheses have been prepared only for a subset of conflicts, however. Moreover, the syntheses do not "take sides" on which recommendation should be followed.

As described earlier, HR 2300 authorizes HHS to contract with a "qualified consensus-building organization such as the [AMA] Physician Consortium for Performance Improvement" to develop guidelines "in concert" with physician specialty organizations. The legislation is silent, however, on how the organization under contract with HHS would handle conflicting recommendations from different specialty organizations. One possibility is that this organization would somehow resolve conflicts by endorsing one guideline and rejecting the others; alternatively, the organization could promulgate the conflicting recommendations and physicians who followed any of them could claim the safe harbor protection. HR 2653 gives HHS the authority to select the professional organizations that issues the guidelines that serve as safe harbors. Again, this leaves open the question of whether HHS will decide which organization's guidelines create safe harbors when conflicting guidelines are issued by more than one organization, or, if instead, HHS will select multiple organizations with conflicting guidelines and allow physicians to shield themselves from liability by following any of them.

From the standpoint of patients injured by medical malpractice, an unfair aspect of many safe harbor proposals is that, while physicians could use guidelines deemed to establish the legal standard of care to shield themselves against liability, the proposals make it difficult for patients to use failures to follow guidelines as evidence of malpractice. Under the Maine program described earlier, for example, plaintiffs in malpractice cases were not supposed to be able to use guidelines to establish liability at all; the rationale was said to be that this one-sidedness was necessary in order to convince practitioners to support the creation of guidelines.(10)

Both HR 2300 and HR 2653 retain aspects of one-sidedness. Under both bills, plaintiffs could introduce a guideline to show that a defendant deviated from the standard of care only if the guideline previously had been introduced by the defendant, presumably to prove that the standard of care had been met. Since physicians ostensibly would rely on guidelines only when they were confident that the guidelines would shield them from liability, there should be few instances in which plaintiffs would be able to use failure to follow guidelines as evidence of malpractice. Moreover, both bills would establish panels of physicians in place of judges and juries to decide if a physician defendant was in fact shielded, and a court could reject a panel's finding in favor of the physician only if a plaintiff could prove it wrong by "clear and convincing evidence," which is a much higher evidentiary burden of proof than the "more-probably-than-not" standard that traditionally applies to factual allegations in medical malpractice cases. Under HB 2300, a plaintiff could appeal an unfavorable finding by a panel to a special tribunal made up of health care experts, but the tribunal could only overturn a panel's decision in favor of a physician if the plaintiff could show that the physician was "grossly negligent," which again is a much higher burden of proof than the traditional "negligence" standard in malpractice cases.

Arguably the greatest challenge to using practice guidelines as safe harbors is that no single treatment recommendation is likely to be correct for all patients. As a result, guidelines may have trouble serving as scientifically-supported defenses to liability.

When the safe harbors idea was first broached in the early 1990s, the American Medical Association and other physician groups were not enthusiastic. One reason was that they feared that the government and health insurers would adopt guidelines that were designed to reduce spending rather than to improve the quality of care.(11) But an even greater concern was that a safe harbor system would pressure doctors to practice in an excessively uniform manner. As the president of the AMA stated in 1989, "you cannot restrict physicians to one procedure or series of procedures for a specific condition. … No two patients are exactly alike and no two conditions are exactly alike. What we must do is provide physicians with parameters that give them the flexibility to utilize their own skills within an acceptable range of options."(12) Accordingly, the AMA insisted that guidelines contain disclaimers that they should be followed only if the physician decided that they described the correct approach for the patient in question. Even the vaunted Harvard Anesthesia Guidelines, adopted in the mid-1980s and said to have reduced mortality rates from general anesthesia from 1 in 10,000 to 20,000 to 1 in 200,000,(13) included the admonition that they were to be followed unless doing so was "clinically impractical."(14)

The current focus on "precision medicine" reinforces the importance of individually-tailored approaches to treatment. As the White House states, "most medical treatments have been designed for the 'average patient.' As a result of this 'one-size-fits-all-approach,' treatments can be very successful for some patients but not for others. This is changing with the emergence of precision medicine, an innovative approach to disease prevention and treatment that takes into account individual differences in people's genes, environments, and lifestyles. Precision medicine gives clinicians tools to better understand the complex mechanisms underlying a patient's health, disease, or condition, and to better predict which treatments will be most effective."(15)

In an era of precision medicine, it is hard to understand how adhering to a practice guideline could serve as an absolute liability defense. One way that a guideline could describe the correct treatment approach for all patients would be to be detailed enough to cover all cases, but that would be difficult in the absence of a great deal more scientific evidence than is likely to be available. Alternatively, a guideline could be so narrow that it applied to few cases, but then it would not protect a significant number of physicians from liability. Another option would be for guidelines to be very broad, such as embodying HHS' "sentinel event" prohibition that surgeons should not operate on the wrong body part.(16) Insulating physicians who followed such general guidelines from malpractice liability no matter what other mistakes they may have made would be tantamount to eliminating malpractice liability altogether, something that even those who favor safe harbors are unlikely to openly endorse.

The only other option would be to do what the AMA advocated in the late 1980s and include disclaimers in guidelines saying that they should be followed only if they describe the correct approach for the patient in question. But in that case, injured patients could dispute whether guidelines asserted as safe harbors in fact applied to them, thereby defeating the goal of allowing adherence to a guideline to serve as an absolute defense.

Both HR 2300 and HR 2653 appear to acknowledge that guidelines asserted as safe harbors may not apply to the case in question. HR 2300 explicitly states that the panels must "acknowledge the ability of physicians to depart from the recommendations … when appropriate in the care of individual patients,"(17)while HR 2653 requires HHS to "clearly identify any exceptions to the application of the clinical practice guideline" that it promulgates.(18) In short, the safe harbors approach in both bills seems to contemplate that there would be factual inquiries similar to those that the traditional malpractice system engages in when practice guidelines are relied upon to establish the standard of care. The difference is that the bills delegate the inquiry to expert medical panels rather than leaving it the province of judges and juries.

But the goal of replacing judges and juries with medical tribunals could be achieved much more readily than by establishing a cumbersome safe harbor system by creating so-called "medical" or "health" courts.(19) Moreover, both bills would allow plaintiffs to support their cases with panel findings that defendants did not follow guidelines, raising the possibility that physicians will not want to run the risk of such adverse findings and therefore will not assert a safe harbor defense at all; as mentioned earlier, this was the result when Maine established a safe harbor program in the 1990s.

A final concern with a safe harbor approach is that practice guidelines may increase rather than decrease the risk of malpractice liability if they embody "best practices" rather than reflect the legal standard of care, which requires that physicians merely provide care that is "reasonable" rather than what is the "best." For example, the mission of the Physician Consortium for Performance Improvement is to enhance the quality of care, and it therefore develops "evidence-based measures that reflect the best practices and best interest of medicine"(20) (emphasis added). "Best practices" might be closer to "optimal care" than the lesser "reasonable care" standard to which the law supposedly holds physicians. As a result, in order to adhere to guidelines so that they could be used as safe harbors, physicians might have to practice even more carefully than would be necessary in theory to avoid malpractice liability. Physicians therefore might choose not to assert safe harbor defenses even if legislation permitted them to do so.

Conclusion

The challenges described above in crafting and operating effective safe harbors programs suggest that such programs may not be scientifically sound or provide significant protection for physicians from malpractice liability. More importantly, safe harbor approaches arguably misunderstand the real value of practice guidelines in reducing malpractice exposure, which, as the Oregon AHRQ safe harbor planning project found, is their ability to improve the quality of care by giving practitioners sound insights and recommendations. In the future, more emphasis might be placed on promulgating unbiased, evidence-based, precision-oriented guidelines, rather than trying to implement flawed safe harbor regimes.