The Role of Clinical Practice Guidelines in Health Care ReformArnold J. Rosoff, J.D., F.C.L.M. LDI Senior Fellow, Professor and Chair of Legal Studies, and Professor of Health Care Systems, The Wharton School
Volume 1, Number 2; October 1994
This Issue Brief examines current developments in the Clinical Practice Guidelines (CPGs) movement and attempts to project how CPGs will effect changes in the way health care is delivered. A prime focus is how CPGs will likely be treated by the courts, particularly with regard to their impact on medical malpractice litigation.
Introduction Many health care reform proposals under current consideration in Congress feature CPGs, also known as practice parameters, as a means to contain costs and assure quality of care.
CPGs have the potential to improve quality and contain the cost of health care; but there are challenging issues and significant obstacles to the realization of that potential.
What are Clinical Practice Guidelines (CPGs)? CPGs are a set of suggestions, commonly set forth as decision rules, that reflect informed consensus on how a certain illness or condition should be treated.
They are meant to guide physicians toward delivering high-quality care in a more cost-effective manner.
They can be developed by medical professional societies, government agencies, managed care entities, etc.
CPGs are basically of two types: Quality-enhancing guidelines are primarily intended to improve medical outcomes, often by increasing the amount of care given.
Cost-reducing guidelines are oriented toward cutting costs, generally, by limiting the amount of care given.
Background on the CPG Movement CPGs are not a new innovation; medical professional groups have developed and promoted them for some time.
Historically, CPGs have focused on quality-enhancing guidelines, which called for more and better care, with higher levels of technology and physician training.
Higher echelons of the profession tended to support these calls for more and better care.
Current CPG development has sprung from outcomes research that empirically tests whether certain diagnostic and therapeutic procedures are effective and cost-justifiable.
A major impetus for such research was to explain regional variations in clinical practice patterns.
Researchers track how particular conditions are treated and compare the outcomes of different treatment approaches (effectiveness research).
This research enables researchers to do rigorous cost-benefit analysis on large numbers of cases, linking different treatment approaches to observed outcomes.
Some tests and procedures increase treatment cost without improving patient outcomes enough to justify their use.
Extensive empirical evidence of how well a treatment works and what it costs does not free health care policy makers from tough value judgments. The question remains whether a given expenditure is justifiable in human terms, bounded by the hard realities of what we can afford.
Recent Developments: Why the Current Strong Interest in CPGs?
Under pressure to limit health care system costs, recent CPG development has focused on cost-reducing guidelines, aimed at treating patients with fewer, less expensive, and more cost-effective procedures.
Ideally, CPG's should promote practices that both improve quality and reduce cost; but the main focus is clearly on cost containment.
Physicians, even those who supported CPGs in the past, may not support them now that the primary objective is cost reduction, not quality improvement.
They fear "cookbook medicine" and the erosion of their professional autonomy. Payers may use CPGs to deny payment for care that doctors believe should be provided to their patients despite the cost.
Some physicians simply doubt the scientific validity of CPGs. They tend to weight their own personal experience more than the results of even large data-set studies.
Fearing malpractice liability, many physicians practice "defensive medicine" and are wary of pressures to provide less care.
CPG proponents seek to answer the objections and gain physician support.
Proponents argue that CPGs are not "cookbooks" requiring rigid conformity; they leave room for physician discretion and professional judgment.
Many federal and state health care reform proposals offer various malpractice immunities for physicians who support and follow CPGs.
Increased Use of CPG's Raises Important Legal Questions.
How will the courts regard and treat CPGs?
Traditionally, the law measures doctors' actions by reference to professional custom and practice.
Once a substantial number of physicians have adopted a new CPG, it will represent customary practice and the traditional liability rule will protect those who follow it.
Can both plaintiffs and defendants use CPGs in malpractice litigation?
During the transition, physicians who follow a new CPG may deviate from professional custom and thus, face a higher risk of liability.
Courts may treat CPGs in a variety of ways:
Guidelines may be directly "plugged in" as the legally accepted standard of practice.
They may be evidence of professional consensus as to what is appropriate care, giving the CPG the status of testimony by a well-qualified, highly credible expert witness.
Such treatment of guidelines is questionable if the CPG actually represents a deviation from prevailing professional practice.
Moreover, if there are multiple, conflicting guidelines, the resulting "battle of the experts," could complicate and hinder adjudicative processes.
The legal status of CPGs will depend on a number of factors:
Even without the full weight of professional custom and practice, a particular CPG may be the standard followed by a "respectable minority" of the profession. Many states do not consider a practice negligent if a "respectable minority" follows.
Clearly, a doctor who conforms with a recognized CPG can cite this in his or her defense ("shield" use).
The immunity may vary depending on statutory language. Under a 1990 Maine law, physicians who act in compliance with CPGs may use this as an "affirmative defense." A 1992 Minnesota statute makes such compliance an "absolute defense."
May a patient who claims s/he was harmed because the doctor failed to follow an applicable guideline use such failure as proof of the doctor's negligence ("sword" use)?
In fairness, the CPG's standard of care should be available to both parties equally. Constitutional principles of "equal protection of the laws" might also dictate such symmetry.
However, political pressures have acted to allow use of CPGs only by physician-defendants (shield use only). Presumably, physicians will support CPG development, dissemination, adoption, and use only if they see it as being in their interest to do so. Allowing sword use would undercut this perception.
CPG Policy Suggestion To spur policy debate, the author suggests the following broad principles:
The statutory provisions that recognize CPGs and prescribe their effect.
Who issues a particular guideline (the "development auspice"):
For example, CPGs issued by a well-regarded professional body, such as the American College of Obstetrics and Gynecology (ACOG) would presumably carry more weight than CPGs issued by an HMO.
Likewise, CPGs issued by the federal Agency for Health Care Policy and Research (AHCPR) would be more influential than those issued by ACOG. The status of AHCPR-generated guidelines might be prescribed by federal law.
Whether a single ("unitary") CPG is recognized for a particular type of treatment or, instead, multiple, competing ("pluralistic") CPGs are recognized.
The American pluralistic system allows for competition in CPG development, and could result in more rapid evolution of guidelines. Also, it may be politically difficult to prevent the development of multiple, competing CPGs.
Having a unitary CPG would ease the burden of determining what is appropriate care in malpractice cases. Allowing pluralistic CPGs would open the door to litigation as to which was the "more correct" standard.
Whether CPGs are certified and, if so, by whom (the "certification auspice").
Whether a unitary or pluralistic system is used, certification of CPGs by a state or federal agency, such as AHCPR, might be required.
If certification is too cumbersome or costly, it could slow CPG development or halt the state of the art.
Development and use of CPGs offers substantial benefits and should be encouraged by legislatures and courts.
A pluralistic system should be adopted, under which all interested parties can develop and promote the use of their CPGs.
Legislation should be passed directing courts to recognize a CPG as establishing the acceptable legal standard of care if the CPG has been certified by the designated government agency.
AHCPR, or an equivalent federal sub-agency of HHS, should be the designated certifying agency. To be certified, a CPG must be:
Developed through solid, scientific outcomes research, using an appropriate and adequately large clinical practice data base, using appropriate methodology, as defined by AHCPR regulations. Developed with input from qualified medical professionals, and with provision for prompt, periodic updating, to incorporate experience gained through clinical practice using the CPG. A reasonable cost of certification, and periodic recertification, should be borne by the entity issuing the CPG. General costs related to AHCPR's activities as the certifying agency should be borne by the HHS budget.
The law should favor shield use of CPGs (by defendants) over sword use (by plaintiffs) only so far as necessary to gain the support of the medical community.
This brief is based upon a presentation to a February 1994 conference on "National Health Care Reform: The Legal Issues," at the Case Western Reserve University School of Law. Professor Rosoff's article on this issue will be included in a symposium issue of Health Matrix: Journal of Law Medicine, scheduled for publication in 1995.
Published by Alan L. Hillman, M.D., M.B.A., Director
Leonard Davis Institute Lowell I. Arye, M.S.S.A., Associate Director
Center for Health Policy Sara D. Urowitz, M.A., Policy Analyst
University of Pennsylvania
ISSUE BRIEFS synthesize the recent results of research being conducted by LDI's Senior Fellows, a consortium of Penn scholars who are engaged in the study of medical, economic, and social and ethical issues that influence how health care is organized, financed, managed, and delivered in the United States and internationally. Participating Penn schools: School of Dental Medicine, School of Medicine, School of Nursing, and The Wharton School.
The views expressed in this ISSUE BRIEF are those of the author(s) and do not represent the positions of the Leonard Davis Institute of Health Economics, the Center for Health Policy, the University of Pennsylvania, or other sponsoring organizations.
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