The consistent use of well-developed and medically appropriate practice guidelines has two potentially compelling benefits. First, scientifically reliable guidelines can improve medical practice by reducing the incidence of misdiagnosis and inappropriate treatment decisions. Guidelines can improve the consistency with which particular procedures are chosen and applied to particular diagnoses, especially when they delineate national standards of care. In addition, they can improve clinical outcomes and promote the efficient use of resources in a health care system dominated by managed care rationing.
Second, if major inroads are made into creating and disseminating guidelines, their use may improve the process of malpractice litigation when the practice of medicine goes awry or when insurance coverage is denied. Plaintiffs already rely on guidelines in attempting to prove that a defending physician, hospital, or other health care provider deviated from the applicable standard of care. In contrast, defendants seek to introduce guidelines to demonstrate that their actions or judgments were consistent with the standard of care.
The legal and medical professions are currently debating the value of practice guidelines as conclusive evidence of the standard of care in both individual coverage and professional liability cases. Nationally accepted guidelines can help streamline the judicial process by providing courts and juries with clear standards against which to measure a provider’s behavior in practicing medicine. However, given the legitimate variation in which procedures are considered appropriate for certain diagnoses and the need for physicians to exercise independent medical judgment in cases where variables preclude simple solutions, guidelines may have only limited utility in the legal process. As J. Rosser Matthews proffers:
[E]ven though the introduction of practice guidelines may promote the policy objective of cost-effectiveness in the delivery of health care services, their use to establish culpability in actual cases may be more difficult because the structure of legal reasoning focuses on the particular facts in the case at hand rather than appealing to abstract decision procedures.1
Although the use of guidelines in practice presents a promising solution for improving care and rationalizing the use of health care products and services, this does not provide an unambiguous strategy for reducing the number of “bad” decisions or outcomes.2 The Institute of Medicine’s (IOM) Guidelines for Clinical Practice: From Development to Use emphasizes that persistent commitment on the part of practitioners and policymakers toward developing and disseminating guidelines through rigorous methods is crucial to their future success.3
The Tenth Circuit Court of Appeal’s surprising deference to a health plan’s reliance on its administrator’s own guidelines in denying coverage prospectively is essentially making a medical decision to deny access to coverage, which casts doubt on the possibility that the courts will condition the evidentiary weight of guidelines on their success in the peer review process and their acceptance by nationally accredited bodies. Due to this seemingly blind approval by one region of the federal judiciary, the future of guidelines remains uncertain. Their potential to improve both the practice of medicine and the legal process when that practice fails is tremendous. However, even if a national body is ordained as the ultimate arbiter of which guidelines are deemed “gold standards,” a physician should neither be deemed negligent simply for departing from a guideline’s recommendations nor be deemed innocent simply for adhering to them. In light of the fact that issues arise regarding the appropriateness of guidelines as the standard of care for one particular patient, not only is it not desirable for guidelines to be deemed conclusive, it is not remotely possible in practical terms.
Guidelines have valuable utility in ascertaining the applicable standard of care in malpractice cases, but they should not be afforded conclusive weight.
DEFINING PRACTICE GUIDELINES
A legal and policy exploration of practice guidelines requires a basic understanding of their composition, both in form and substance. This section addresses the range of definitions.
Also referred to as “clinical algorithms,” “critical pathways,” “clinical practice protocols,” and “practice parameters,” the term “practice guidelines” encompasses a range of functions and formats.4 The IOM’s Clinical Practice Guidelines: Directions for a New Program defines guidelines as “systematically developed statements to assist in practitioner and patient decisions about appropriate health care for specific clinical circumstances …”5 “Guidelines are intended to assist practitioners and patients in making health care decisions … and to serve as a foundation of instruments to evaluate practitioner and health system performance.”6
Practice guidelines serve various substantive functions. They provide guidance on the use of medical devices, criteria for prescribing pharmaceuticals, and recommendations for treating specific ailments.7 Regardless of their format, they are aimed at promoting both higher quality and more cost-effective health care by making the clinical knowledge generated through outcomes research available and more easily accessible.8 Representatives of all parties in the health care continuum hope that use of guidelines will improve the quality of care, as well as ameliorate the “perceived value obtained for health care spending. Beyond such widely held aspirations, individual groups differ in the emphasis they place on other narrower objectives.”9 Regulators, administrators, and purchasers are interested in controlling cost and decreasing variation in practice patterns.10 Practitioner groups seek to maintain professional autonomy to free medical decision-makers from engaging in “external micromanagement.”11 Advocates of patient rights perceive guidelines as a means of giving patients enough information to make good decisions, clarifying their preferences, and improving patient autonomy.12
In their ideal form, guidelines provide a framework for medical decision-making. As defined by the IOM, they have “one crucial purpose: to assist individual practitioners and patients in making decisions about specific clinical problems.”13 They provide recommendations for managing a patient’s care that identify a management strategy or a range of strategies14 reflecting informed judgment on how to react to a particular medical condition.15 Individuals and organizations use guidelines “to structure organizational procedures, to guide equipment purchases and hiring decisions, and to set and implement priorities for monitoring, feedback, and other efforts to assess and improve performance.”16
Physicians have come to rely significantly on practice guidelines, tending to prefer them over other resources. One study asked medical directors to rank sources used in their decision-making processes.17 The choices included medical journals, expert opinions, U.S. Food and Drug Administration (FDA) documents, practice guidelines, medical policies, National Institutes of Health (NIH) conferences, and practices of other plans.18 Whereas less than 60% considered other sources optimal, use of practice guidelines was ranked ahead of national expert information, government documents, and NIH conferences.19
THE DEVELOPMENT OF PRACTICE GUIDELINES
For decades, public and private medical associations, as well as non-medical bodies, have created practice guidelines through a variety of approaches. They vary substantially in authorship, form, dissemination, and purpose. Some guidelines are developed by specialty associations, such as the American Academy of Pediatrics. Others are developed purely through actuarial methods, such as those created by Milliman and Robertson. At another end of the continuum are protocols that have undergone extensive peer review by practitioners. Societies, such as the American Academy of Pediatrics, the government through NIH, and hospitals, have been at the forefront of the guidelines trend.20 In fact, so many organizations have written so many guidelines that the Agency for Health Care Policy and Research (AHCPR), along with the American Association of Health Plans (AAHP) and the American Medical Association (AMA), created a National Guideline Clearinghouse (NGC) on the Internet.21
ESTABLISHMENT OF THE AGENCY FOR HEALTH CARE POLICY AND RESEARCH
In November 1989, Congress amended the Public Health Service Act to establish the AHCPR as an independent agency.22 The legislation requires that a program be instituted “for the purpose of promoting the quality, appropriateness, and effectiveness of health care,” and has resulted in the creation of the AHCPR’s Forum for Quality and Effectiveness in Health Care (the Forum).23
More specifically, the AHCPR is charged with the responsibility of supporting research, gathering data, and other activities:
To arrange for the development and periodic review and updating of – (1) clinically relevant guidelines that may be used by physicians, educators, and health care practitioners to assist in determining how diseases, disorders, and other health conditions can most effectively and appropriately be prevented, diagnosed, treated, and managed clinically; and (2) standards of quality, performance measures, and medical review criteria through which health care providers and other appropriate entities may assess or review the provision of health care and assure the quality of such care.24
Pursuant to a request for advice on how the agency should approach its responsibility for guidelines, the IOM appointed a study committee to provide technical help in developing good guidelines.25 Evaluations have revealed that the AHCPR has faced a daunting task in improving the quality of medicine nationwide. Given the newness of the program and a pattern of significant staff turnover, the agency has found itself “in flux.”26 The magnitude of the responsibility imposed on the guidelines panel chairpersons was more demanding than initially envisioned, the literature reviews were more costly in terms of time and money than expected, and explicit instructions regarding methodology were lacking. Contracting with other organizations was part of the agency’s response to these difficulties.27 In 1991, it began to expand its reach by awarding contracts for the creation of three sets of protocols:
to the American Academy of Pediatrics (with subcontracts to the American Academy of Family Practice, the American Academy of Otolaryngology, and the Children’s Hospital of Pittsburgh) for otitis media in children;
to the RAND Corporation for congestive heart failure and post-stroke rehabilitation; and
to the Center for Health Economics Research (with a subcontract to the Harvard School of Public Health) for a literature analysis and review.28
Although the contracting approach has left AHCPR out of direct involvement in reviewing the literature and scientific evidence, the Forum expected to exercise substantial oversight over the panels, work plans, and literary reports,29 thereby reducing the risk that the specialty organizations would lack impartiality in the process.
BEYOND THE MEDICAL USE OF PRACTICE GUIDELINES
On a purely medical plane, practice guidelines and their purported utility are straightforward and uncontroversial. However, medicine is no longer defined in purely curative terms. The inescapable reality is that the practice of medicine is largely concerned about and often hampered by coverage, cost, and regulatory requirements. Furthermore, interest in practice guidelines on the part of the multiple players in the American health care system has increased in light of the dominance of managed care, which allows plans to maintain control over providers.30 Because, by definition, managed care organizations (MCOs) control financial output to providers, they also profoundly influence the medical decision-making process.
Contracts between MCOs, including health maintenance organizations (HMOs), and physicians generally include clauses that vest discretion in the MCO to prospectively decide when a particular treatment or procedure is medically necessary and, therefore, whether it will be covered.31 Most MCOs and some physician practice organizations employ practice guidelines to curb costs in expensive areas, such as asthma management.32 The majority of insurance purchasers are companies that procure coverage for employees who, in turn, are reluctant to accept increases in premiums. The employers advocate that the health care delivery system institute utilization management systems out of the belief that quality of care will improve as a result of more consistent practice patterns, thereby yielding lower costs by reducing coverage of unnecessary and redundant services.33 These customers are insisting that practitioners be held increasingly accountable for the level of care delivered to patients.34
In the bureaucratic and contentious environment in which MCOs have come to operate, denial of care by insurers and poor outcomes by providers have supported a culture of aggravated and adversarial battles – patients are demanding accountability. Guidelines perhaps stir up the most controversy when used in the process of litigating coverage and quality of care disputes. It is interesting that the NGC Web site noted previously enumerates a purely medical group of players as its “intended audience,” including health care providers and provider organizations, medical specialty and professional societies, researchers, policymakers, and employee benefits managers.35 However, it fails to mention lawyers and judges. It also explicitly refuses to make:36[W]arranties concerning the content or clinical efficacy of the clinical practice guidelines and related materials. Inclusion of any guideline in the NGC does not constitute or imply an endorsement by the AHCPR or its contractor[s]… of the guidelines or of the sponsor or developer of any such guidelines.37
In fact, virtually all guidelines contain disclaimers that the recommendations contained therein are not intended to be deemed “the standard of care.”38 It appears that guideline creators intentionally avoid this kind of explicit endorsement due to concerns over potential liability.
RECOGNIZING BIAS IN THE UTILITY OF GUIDELINES FOR OFFENSIVE AND DEFENSIVE PURPOSES
Regardless of whether guidelines eventually constitute conclusive evidence of the applicable standard of care in malpractice cases, the future of guideline use for litigation purposes may be asymmetrical.39 The degree to which guidelines should be regarded as conclusive evidence of the standard of care may depend on whether courts are skewed in accepting them for inculpatory or exculpatory purposes.
Much controversy surrounds the problems that can arise when legislatures make value judgments as to whether physicians can escape personal liability when they follow guidelines, regardless of the independent judgment exercised.
Andrew Hyams conducted a survey of reported cases from 1980 through 1994 to ascertain whether plaintiffs or defendants have been more successful in using guidelines.40 The study reveals that plaintiffs have used them with a substantially higher degree of success than defendants.41 The following are examples of cases evaluated that illustrate how the evidentiary role of guidelines plays out in both offensive and defensive contexts.
A. Inculpatory Guidelines
In the cases where plaintiffs have used guidelines effectively for inculpatory purposes, guidelines helped these parties to oppose summary judgment motions or to prevail on motions for judgment as a matter of law.42 One example is James v. Woolley, in which the Alabama Supreme Court reversed a summary judgment decision granted in favor of the defendants in a malpractice action brought to recover for the paralysis of a newborn’s arm as a result of delivery.43 The court found persuasive the deposition testimony of an expert who relied on an American College of Obstetrics and Gynecology (ACOG) technical bulletin that advises performing a Cesarean section in any situation where a woman with gestational diabetes gives birth to a baby weighing over 4000 grams.44 Because the plaintiff, as the non-moving party, presented evidence from which an inference could be drawn to support his claim, the appellate court remanded the case so a jury could weigh the material issues of fact.45
In Washington v. Washington Hospital Center,46 the District of Columbia Court of Appeals partially relied on the plaintiff’s proffer of guidelines promulgated by the American Association of Anesthesiology (AAA) in ascertaining the standard of care in a case brought on behalf of a woman who suffered catastrophic brain injury.47 In doing so, the court rejected the defendant’s argument that the AAA Standards for Basic Intra-Operative Monitoring, which “encouraged” the use of carbon dioxide monitors, were merely “emerging” recommendations that were not “mandatory.”48 According to the court’s reasoning, “standard of due care … necessarily embodies what a reasonably prudent hospital would do … and hence care and foresight exceeding the minimum required by law or mandatory professional regulation may be necessary to meet that standard,” and guidelines and supporting medical journal articles that deem a standard as emerging can have a “bearing” on an expert’s opinion testimony.49
This case elucidates the challenges guideline drafters face when they attempt to couch directions or recommendations in tentative language intended to prevent plaintiffs from using guidelines offensively.50 It also demonstrates the inherent limitations plaintiffs face when a court can only accept guidelines as persuasive when presented via expert testimony, but not as independent exhibits.
B. Exculpatory Guidelines
Guidelines have also inured to the benefit of physicians defending malpractice suits. Levine v. Rosen51 is an example of a case in which a defendant successfully employed guidelines for exculpatory purposes. In a case against a physician for failure to diagnose breast cancer, Mrs. Levine visited her physician to examine apparent abnormalities on her breast,52 but Dr. Rosen did not deem it necessary to order any diagnostic tests. However, a subsequent mammogram revealed adenocarcinoma.53 The defendant submitted into evidence ACOG guidelines recommending “regular mammography” within the treating physician’s discretion to refute American Cancer Society recommendations of annual mammograms for women over the age of 50.54 The appellate court remanded the case and suggested that the trial court instruct the jury clearly on the “two schools of thought” doctrine that allows for reasonable regional variation in standards of care, and explains that it does not shield a doctor from liability for failure to recognize symptoms.55
CONCLUSION – WHERE DO WE GO FROM HERE?
Guidelines should never be deemed dispositive as the applicable standard of care applied in a malpractice action. Both the medical and legal professions are far from witnessing the day when guidelines can be conclusive and where following them diligently would preclude further inquiry into a physician’s conduct. However, the Tenth Circuit’s shocking decision in Jones v. Kodak56 to uphold a health plan’s benefit denial based on guidelines in the first place raises disturbing questions about the future of guidelines. Perhaps some courts are closer than they should be in blindly accepting guidelines without examining their relevance or reliability. “Rather, individual courts will continue to balance the rights of individuals against the needs of society at large in a case-by-case basis …”
Harold C. Sox, outgoing president of the American College of Physicians-American Society of Internal Medicine, opines that guidelines will increasingly be viewed as the standard of care and will actually help in defending physicians.58 “In a just and rational world, physicians who follow peer reviewed professional guidelines will be held blameless when a patient has bad luck … I’m not aware of a situation where a physician followed such a guideline appropriately and lost the case.”59 As guidelines become more widely accepted as the standard of care, prudent physicians will have no choice but to be aware of them. “Imagine being on the witness stand and testifying that you don’t know what your specialty society recommends …60”
The reality that guidelines will inevitably be afforded increasing evidentiary weight over the coming years is not objectionable. However, we are far from ready for courts to deem guidelines conclusive without first establishing a nationally appropriate measure of their validity. Until guidelines become more standardized and reliable according to objective and nationally recognized standards, due process concerns should prohibit judicial inquiry from ceasing after the question of whether a defendant obeyed a particular guideline is addressed. Rather, both parties should be afforded the due process of claiming adherence to or departure from the standards, or of challenging the standards themselves.
Perhaps the puzzle over the definition of the medical profession epitomizes the debate over the appropriate use of practice guidelines: “Is medicine a science or an art?”61 Accepting the theory that it should be considered both leads to the inevitable conclusion that guidelines cannot be deemed conclusive without stripping the medical profession of its autonomy.
Footnotes
↵ Jodi Finder is an associate in the Washington, DC, office of Kirkpatrick & Lockhart LLP, where she counsels clients on U.S. Food and Drug Administration issues. This article is an abridged version of a prior article by Ms. Finder. For copies of that article or for further information, please contact her at (202) 778-9044 or [email protected].
↵ 1 J. Rosser Matthews, Practice Guidelines and Tort Reform: The Legal System Confronts the Technocratic Wish, 24 J. HEALTH POL., POL’Y & L. 275, 275 (1999).
↵ 2 See COMMITTEE ON CLINICAL PRACTICE GUIDELINES, INSTITUTE OF MEDICINE, GUIDELINES FOR CLINICAL PRACTICE: FROM DEVELOPMENT TO USE, at 39 (Marilyn J. Field & Kathleen N. Lohr eds. 1992) (IOM I).
↵ 3 See id.
↵ 4 This article refers to two labels, practice guidelines (or guidelines) and protocols. For purposes of the topics discussed herein, the two terms are used interchangeably.
↵ 5 COMMITTEE TO ADVISE THE PUBLIC HEALTH SERVICE ON CLINICAL PRACTICE GUIDELINES, INSTITUTE OF MEDICINE, CLINICAL PRACTICE GUIDELINES: DIRECTIONS FOR A NEW PROGRAM, at 8 (Marilyn J. Field & Kathleen N. Lohr eds. 1990) (IOM II).
↵ 6 Id. at 2–3.
↵ 7 See Deborah W. Garnick et al., Can Practice Guidelines Reduce the Number and Costs of Malpractice Claims?, 266 JAMA 2856, 2856 (1991) (stating that practice guidelines are expected to change practice styles, reduce inappropriate and unnecessary care, and cut costs).
↵ 8 See Arnold J. Rosoff, The Role of Clinical Practice Guidelines in Health Care Reform, 5 HEALTH MATRIX 369, 370 (1995) (reviewing the development of clinical practice guidelines and their impact on the health care reform debate).
↵ 9 See IOM I, supra note 2, at 23.
↵ 10 See id.
↵ 11 Id.
↵ 12 Id.
↵ 13 Id. at 40.
↵ 14 See Edward B. Hirshfeld, Practice Parameters and the Malpractice Liability of Physicians, 263 JAMA 1556 (1990).
↵ 15 See Rosoff, supra note 8, at 370.
↵ 16 IOM I, supra note 2, at 41.
↵ 17 See Claudia A. Steiner et al., The Review Process Used by U.S. Health Care Plans to Evaluate New Medical Technology for Coverage, 11 J. GEN. INTERNAL MED., at 294 (1996) (concluding that no one source of information was definitive).
↵ 18 Sara Rosenbaum et al., Who Should Determine When Health Care is Medically Necessary?, 340 NEW ENG. J. MED. 229, 231 (1999) (citing Steiner et al., supra note 17, at 294–302).
↵ 19 See id.
↵ 20 See BARRY R. FURROW ET AL., HEALTH LAW 365 (1995) (citing origins of practice guidelines and anticipated benefits and harms).
↵ 21 See AHCPR, National Guideline Clearinghouse (visited February 19, 2002) http://www.guideline.gov/index.asp; see also Mark Crane, Clinical Guidelines: A Malpractice Safety Net?, MED. ECON., Apr. 12, 1999, at 236, 239 (adding that many of these clinical guidelines contradict each other).
↵ 22 See 42 U.S.C. § 299b-1(a) (1994); Pub. L. No. 101–239 (1990).
↵ 23 42 U.S.C. § 299b-1(a) (1994).
↵ 24 Id.
↵ 25 See IOM II, supra note 5, at 1.
↵ 26 See IOM I, supra note 2, at 165.
↵ 27 See 42 U.S.C. § 299b-1(c) (1994).
↵ 28 See IOM I, supra note 2, at 56.
↵ 29 See id.
↵ 30 See RAND E. ROSENBLATT ET AL., LAW AND THE AMERICAN HEALTH CARE SYSTEM 568 (1997).
↵ 31 See id.
↵ 32 See id.
↵ 33 See Marlene Travis & Sue Ellen Bell, Strategies for Managing Medical Risks in Managed Care Organizations, in GUIDE TO MANAGED CARE STRATEGIES 1999 119, 120 (Joseph Burns et al. eds. 1998) (discussing the possibility of reducing health care costs in MCOs through adoption of a quality care management process).
↵ 34 See id.
↵ 35 See AHCPR, National Guideline Clearinghouse, supra note 21 (identifying the intended audience of the Web site).
↵ 36 See id.
↵ 37 Id.
↵ 38 Crane, supra note 21, at 240 (noting that virtually all drafters of guidelines disclaim their recommendations as standards of care).
↵ 39 See Rosoff, supra note 8, at 388 (evaluating the use of clinical practice guidelines in both offensive and defensive contexts).
↵ 40 Andrew L. Hyams et al., Medical Practice Guidelines in Malpractice Litigation: An Early Retrospective, 21 J. HEALTH POL., POL’Y & L. 289, 295 (1996) (discussing a computerized legal research study performed by the authors to assess use and performance of medical malpractice guidelines in the United States).
↵ 41 See id. at 295–296.
↵ 42 See id. at 296.
↵ 43 523 So. 2d 110, 112–13 (Ala. 1988) (finding an issue of material fact as to the physician’s negligence).
↵ 44 See id.
↵ 45 See id. at 113.
↵ 46 579 A.2d 177 (D.C. App. 1990) (describing a case in which a family sued on behalf of a patient in a persistent vegetative state).
↵ 47 Id. at 182.
↵ 48 See id. (explaining that plaintiff’s expert witness partially relied on practice guidelines in giving testimony on the use of end-tidal carbon dioxide monitors).
↵ 49 Id. (emphasis in original).
↵ 50 See Hyams et al., supra note 40, at 299 (discussing use of inculpatory guidelines).
↵ 51 616 A.2d 623 (Pa.1992) (holding that clinical guidelines may be used under a “two schools of thought” doctrine).
↵ 52 See id.
↵ 53 See id. at 625 (adding that the patient subsequently underwent a right modified radical mastectomy and chemotherapy).
↵ 54 See id. at 625–26.
↵ 55 Id. at 628 (noting that upon retrial, the judge should specify on which allegation of negligence there were “two schools of thought”).
↵ 56 Jones v. Kodak Medical Assistance Plan, 169 F.3d (10th Cir. 1999).
57 Matthews, supra note 1, at 299 (implying that guidelines may encourage dialogue between technocratic devotees and legal and medical critics).
↵ 58 Crane, supra note 21, at 239 (discussing ideas of Harold C. Sox, who believes physicians will effectively write guidelines to avoid litigation).
↵ 59 Id.
↵ 60 Id. at 243 (quoting practitioner Gil Solomon, MD).
↵ 61 See Matthews, supra note 1, at 275 (noting how ambiguity in self-definition has historically plagued medical professions).
