Virtual Mentor

Virtual Mentor. December 2004, Volume 6, Number 12.

Policy Forum

  • Print

Cost and Clinical Practice Guidelines: Can Two Wrongs Make It Right?

In today's medical economy, cost effectiveness is becoming a bigger factor in developing standardized clinical practice guidelines.

Ellen K. Hummel, MD, and Peter A. Ubel, MD

In the good old days, physicians did what was best for each individual patient in their care, without considering cost or having to figure out whether an HMO or accreditation board was looking over their shoulders. Physicians never worried about practicing "cost-effective medicine," nor did they concern themselves with whether Health Plan Employer Data and Information Set (HEDIS) or some other standardized quality measure would be used to tabulate their performance.

But the clinical world is changing. The medical literature overflows with cost-effectiveness analyses, putting physicians in the awkward position of having to judge whether a particular patient will benefit enough from a specific therapy for that therapy to be cost-effective. Journals are also stuffed to the brim with new clinical practice guidelines (CPGs), nudging physicians to adopt a rapidly expanding array of unfamiliar screening and therapeutic approaches to their patients.

Is it any wonder that physicians regularly express their skepticism about the true relevance of both cost-effectiveness analyses and clinical practice guidelines to their clinical practice?

And yet now, the editors of Virtual Mentor have asked us to comment on whether clinical practice guidelines ought to incorporate cost-effectiveness information. At the risk of alienating our colleagues, we plan to discuss why we think the best way to help physicians become more comfortable with both cost-effectiveness issues and with CPGs is to make certain the 2 are inseparable.

Resistance to Practicing "Cost-Effective" Medicine

It is not surprising that physicians disparage cost-effectiveness in health care, given that traditional medical education teaches that they should not consider the cost of medical interventions when treating individual patients [1]. Physicians may also recoil at the idea of cost considerations because they associate such considerations with ever-increasing administrative demands on their time made by third-party payers. What's more, the media bombard us with tragic stories of patients who have been denied needed health care services because they had the misfortune of being enrolled in unscrupulous, greedy, for-profit managed care plans. No wonder most of us would prefer to avoid considering cost-effectiveness in clinical practice.

Nevertheless, the health care situation in this country is making it increasingly difficult to ignore the relevance of cost to clinical practice. On a societal level, more than 40 million Americans lack any kind of health insurance coverage because it is too expensive for them to buy for themselves or through their employers. On a community level, many hospitals are experiencing nursing shortages as the rising cost of providing health care services prevents them from offering more attractive compensation packages [2]. On an individual level, some patients are unable to comply with prescribed medication regimens because they simply cannot afford the high drug prices [3]. But how can we encourage resistant physicians to control costs when they feel morally obligated to pursue the best interests of their individual patients without regard to costs?

Are clinical practice guidelines the solution?

Resistance to Practicing According to CPGs

CPGs offer a potentially palatable way for physicians to consider the cost-effectiveness of medical interventions. High quality guidelines are based on thorough and systematic reviews of clinical and cost-effectiveness evidence. Moreover, CPGs are often developed by representative panels of experts, including members with scientific, clinical, and economic expertise in a particular topic, as well as patients, ethicists, and representatives of relevant special interest groups. Furthermore, the rationale for the development of guidelines and their cost implications can be made publicly available for ongoing debate and discussion through publication in reputable medical journals. Finally, according to the Institute of Medicine, evidence-based clinical practice guidelines are decision aids that "assist practitioner and patient in discussions about appropriate health care for specific clinical circumstances" [4]. As such, they can provide cost-effectiveness information to physicians without threatening the physicians' autonomy to decide what is best for individual patients.

Despite all of these strengths of CPGs, however, physicians are often concerned that guidelines are tainted by financial conflicts of interest. Take as an example, a recent controversy surrounding the update of the Adult Treatment Protocol III (ATP III) guidelines for the treatment of cholesterol in adults, issued in July by the National Cholesterol Education Program (NCEP). Although the NCEP has been widely considered a credible source of cholesterol guidelines, the latest update of the ATP III recommendations has been questioned by the Center for Science in the Public Interest (CSPI), in part because most of the panel members who authored the update have relationships with the pharmaceutical industry. Of note, the recent ATP III update includes suggestions that intensification of lipid-lowering therapy beyond previously recommended levels might be beneficial in certain groups of patients [5].

It is impossible to eliminate all conflicts of interest in guideline development. As Barbara Alving, acting director of the National Heart, Lung and Blood Institute notes, "the experts who are most knowledgeable in a subject area are also the same people whose advice is sought by industry, and most guideline panels include experts who interact with industry" [6].

Why Cost-Effectiveness and CPGs Belong Together

Although we do not wish to take a position in the controversy over the ATP III update, we believe that this dispute illustrates precisely the reason why cost-effectiveness should always be addressed explicitly in CPGs. As is the case with the ATP III update, an interest group or individual invariably stands to profit from the implementation of any guideline. Therefore, the conflicts of interest of the source of a guideline are necessarily relevant to the perceived value of its recommendations. Although public disclosure of conflicts of interest is an important first step towards enhancing public perception of the objectivity of a source of a guideline, it is not sufficient action to engender trust.

Instead, to increase trust, all guidelines should include explicit information about cost-effectiveness to help physicians better assess the objectivity of the recommendations. Cost-effectiveness information enhances the credibility and usefulness of guidelines by showing their reasonableness. If a guideline recommends more aggressive lipid lowering without presenting evidence that this would be cost-effective, physicians have good reason to be skeptical about the value of this recommendation for their practice. Imagine how differently the cholesterol guidelines would have been received if the panel had shown that their new, more aggressive recommendations were still well within accepted cost-effectiveness ratios despite potential conflicts of interest [7].

Including cost-effectiveness considerations helps establish the credibility of CPGs. At the same time, CPGs help clinicians recognize the importance of practicing cost-effective medicine with their individual patients. CPGs can act as a socially sanctioned standard of care, a signal to clinicians that their pursuit of benefits for individual patients needs to be limited by cost-effectiveness concerns. For example, the US Preventive Services Task Force and the American Cancer Society have issued guidelines incorporating cost-effectiveness data which recommend that physicians reduce the frequency of screening low-risk women for cervical cancer. In response to these recommendations, many physicians have actually reduced their screening rates. Hence, through CPGs such as these, physicians may be encouraged by groups of peers and respected authorities to restrain themselves from pursuing rare benefits for their patients.

As our current health care system increasingly forces us to become involved with the costs of medical care, evidence-based CPGs should supply us with reliable and objective advice regarding the cost-effectiveness of treatment options. Furthermore, including cost information in guidelines will enhance their credibility with clinicians by decreasing concerns about conflicts of interest.



References

  1. Hensel WA, Dickey NW. Teaching professionalism: passing the torch. Acad Med. 1998;73:865-870.
  2. Steinbrook R. Nursing in the crossfire. N Engl J Med. 2002;346:1757-1766.
  3. Steinman MA, Sands LP, Covinsky KE. Self-restriction of medications due to cost in seniors without prescription coverage. J Gen Intern Med. 2001;16:793-799.
  4. Agency for Healthcare Research and Quality. National Guideline Clearinghouse (NGC) Disclaimer page. Available at: http://www.guideline.gov/about/disclaimer.aspx. Accessed October 13, 2004.
  5. Grundy SM, Cleeman JI, Merz CNB, et al. Implications of recent clinical trials for the national cholesterol education program adult treatment panel III guidelines. JACC. 2004;44:720-732.
  6. Alving B. Cholesterol guidelines: the strength of the science base and the integrity of the development process. Statement of Barbara Alving, MD, Acting Director. [NIH/NHLBI News Release.] Available at: http://www.nhlbi.nih.gov/new/press/04-09-24.htm. Accessed October 6, 2004.
  7. Ubel PA, Hirth RA, Chernew ME, Fendrick AM. What is the price of life and why doesn't it increase at the rate of inflation? Arch Intern Med. 2003;163:1637-1641.

Ellen K. Hummel, MD, is a Robert Wood Johnson Clinical Scholar and a
general internist affiliated with the University of Michigan and the Ann Arbor Veterans Affairs Medical Center. She is interested in the ethics of health care resource allocation.

Peter A. Ubel, MD, is professor of medicine and professor of psychology at the University of Michigan, a primary care physician at the Ann Arbor Veterans Affairs Medical Center, and director of the Program for Improving Health Care Decisions. He is author of Pricing Life: Why It Is Time for Health Care Rationing (MIT Press, 2000) and is currently writing a book on emotional resilience and the lessons of adversity.

The viewpoints expressed on this site are those of the authors and do not necessarily reflect the views and policies of the AMA.