Insurance contract language exerts the most influence over court decisions about treatment coverage

Court decisions about whether an insurer should cover a medical treatment depend more on insurance contract language than assessments of the treatment's medical appropriateness. This holds whether the insurer uses formal assessments of medical appropriateness, such as clinical practice guidelines or internal assessments. The courts' judgments are particularly influenced by insurance contract language assigning discretion to the insurer, severity of the patient's condition, whether the treatment for which coverage is sought appeared to work for the patient, and court jurisdiction. Until more systematic reforms are undertaken, there is little that guideline developers can do to facilitate judicial reception of their efforts, concludes a study supported in part by the Agency for Health Care Policy and Research (HS08681).

Mark Hall, J.D., of Wake Forest University, Gerard Anderson, Ph.D., of Johns Hopkins University, and their colleagues analyzed 203 Federal and State court decisions made between 1960 and 1994 involving a dispute over public or private health insurance coverage in which the medical appropriateness of a procedure was an issue. Analysis showed that the patient won 54 percent of the time when the insurer relied on formal assessments compared with 57 percent of the time when the assessment was done based on a more local or ad hoc review and 62 percent of the time when there was no explicit assessment. These small differences were not significant.

Courts were more likely to find that there was coverage when the patient had a serious rather than a mild medical condition and when the treatment appeared ultimately effective for that specific patient. The type of insurance and the number of expert witnesses on either side did not appear to influence the outcome.

See "When courts review medical appropriateness," by Dr. Anderson, Mr. Hall, and Teresa Rust Smith, M.A., in Medical Care 36(8), pp. 1295-1302, 1998.

States appear more willing than Federal authorities to approve mergers of health care providers

Increased mergers among health care providers have accompanied the rise of managed care, transforming the health care marketplace from solo physicians and single hospitals to domination by multispecialty group practices and networks of local hospitals. These mergers, by consolidating resources, have the potential to both lower costs and enhance quality. They also have the potential to raise prices. State antitrust agencies have been more willing than Federal authorities to approve mergers that are contingent upon fulfillment of specific conditions, according to Fred J. Hellinger, Ph.D., of the Agency for Health Care Policy and Research.

Twenty States have passed laws that establish formal mechanisms for protecting collaborative activities among health care providers from State and Federal antitrust prosecution over the past 5 years. Also, State attorneys general have issued numerous antitrust consent decrees involving hospital groups. However, these laws and decrees are usually contingent on agreement by the merging organizations to restrain price increases, pass on savings to consumers, and limit profits. These are contingencies that require continued oversight to ensure compliance.

Federal antitrust officials contend that they do not have the resources to monitor compliance and that a merger should be judged solely on its likely effects on market performance. They also are skeptical of the ability of State agencies to hold merging groups to their promises. However, Dr. Hellinger believes that State authorities may be better suited than Federal authorities to ensure compliance; he points out that all States already regulate many aspects of a hospital's operations as part of their licensure function. Thus it would be difficult for hospitals to avoid complying with price agreements by altering their accounting practices or reorganizing their operations. He calls for additional research to inform policymakers about the consequences of State-approved mergers on market performance.

See "Antitrust enforcement in the health care industry: The expanding scope of State activity," by Dr. Hellinger, in the December 1998 Health Services Research 33(5), pp. 1477-1494.

Reprints (AHCPR Publication No. 99-R030) are available from the AHCPR Publications Clearinghouse.

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Research Issues

Masking of author identity to improve fairness in review of medical journal articles remains difficult

Masking the identity of authors of medical journal articles sent to peer reviewers has been suggested as a means to improve quality and fairness of article reviews. However, masking reviewers to author identity as commonly practiced does not improve quality of reviews. Nor is there any difference in masking success between journals with and without masking policies. These are the conclusions of two studies supported in part by the Agency for Health Care Policy and Research (National Research Service Award training grant T32 HS00009), which are briefly summarized here.

Justice, A.C., Cho, M.K., Winker, M.A., and others. (1998, July). "Does masking author identity improve peer review quality?" Journal of the American Medical Association 280(3), pp. 240-242.

Masking author identity from peer reviewers fails to hide the identity of well-known authors. Thus, it may not improve the fairness of review, conclude the study authors. They had two peers review each manuscript in five journals, only one of which routinely masked reviewers. In one study arm (26 manuscripts), both peer reviewers received the manuscript according to usual masking practice. In the other arm (92 manuscripts), one reviewer was randomized to receive a manuscript with author identity masked, and the other reviewer received an unmasked manuscript. Review quality was judged on a 5-point Likert scale by manuscript author and journal editor.

Authors and editors perceived no significant difference in quality between masked and unmasked reviews. Moreover, masking was often unsuccessful (only 68 percent successfully masked). Manuscripts by generally well-known authors were 70 percent less likely to be successfully masked than less known authors. The authors conclude that incomplete masking success limits the ability to assess the effect of masking on review quality.

Cho, M.K., Justice, A.C., Winker, M.A., and others. (1998, July). "Masking author identity in peer review: What factors influence masking success?" Journal of the American Medical Association 280(3), pp. 243-245.

The authors found that masking success is associated with reviewers' research experience, but it appears to be unrelated to a journal's policy on masking. The authors note that using reviewers with less research and reviewing experience (and thus less recognition of renowned researchers) might increase masking success, but the effect on review quality is unknown. They sent manuscripts to seven journals, three with a long-standing policy of masking author identity and four that did not mask author identity. The researchers sent each journal manuscript to at least two reviewers along with a one-page questionnaire.

There was no significant difference in masking success between journals with a policy of masking (60 percent) and those without such a policy (58 percent). This finding held, even after adjusting for reviewer characteristics of age, sex, years of reviewing experience, number of articles published and reviewed, editorial experience, or academic rank. However, reviewers who spent a greater percentage of time in research were less likely to be successfully masked. The authors conclude that masking success appears unrelated to a journal's policy of masking, but it is associated with reviewers' research experience and could be affected by other characteristics.

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AHCPR News and Notes

AHCPR releases its first two evidence reports on sleep apnea and traumatic brain injury

The Agency for Health Care Policy and Research recently released the first two reports—on diagnosis of sleep apnea and rehabilitation for traumatic brain injury—from a new series of evidence reports/technology assessments prepared by Evidence-based Practice Centers (EPCs) under contract to AHCPR. The EPC reports and assessments provide public- and private-sector organizations with comprehensive, science-based information on common, costly medical conditions and health care technologies. In 1997, AHCPR designated 12 academic and nonprofit organizations as EPCs in the United States and Canada. The EPCs review all the relevant literature on designated topics related to prevention, diagnosis, treatment, and management of common diseases and clinical conditions and technology assessments of specific medical procedures or health care technologies.

Forthcoming EPC reports and technology assessments examine drug therapy for alcohol dependence, evaluation of abnormal cervical cytology, treatment of depression with new drugs, treatment of attention deficit/hyperactivity disorder, diagnosis and treatment of acute sinusitis, testosterone suppression treatment for prostatic cancer, and other topics. Recently assigned topics include management of acute chronic obstructive pulmonary disease, management of cancer pain, criteria for weaning from mechanical ventilation, and management of chronic hypertension during pregnancy. Additionally, as a follow-on to the report on traumatic brain injury (TBI) summarized below, the Oregon Health Sciences University EPC will conduct a systematic review of the literature on TBI among children and adolescents.

Summaries of the first two reports were released via the World Wide Web in December. Select to access online highlights (sleep apnea and traumatic brain injury) or the summaries (sleep apnea and traumatic brain injury). Print copies of the summaries are available from the AHCPR Publications Clearinghouse.

Diagnosis of Sleep Apnea. An expensive, all-night test considered the "gold standard" for diagnosing sleep apnea—an under-recognized, under-diagnosed and potentially life-threatening nighttime breathing disorder—still appears to have no rivals, according to a study prepared by the MetaWorks EPC in Boston. But the study also concluded that several less expensive and less time-consuming tests than the overnight, full channel polysomnography (full PSG) appear promising for accurately diagnosing sleep apnea—a condition estimated to affect more than 12 million people in the United States and Canada.

The study's conclusions are based on a systematic review of the best available evidence from published research. MetaWorks was aided in its research by its partners, the Sleep Disorders Centre of Metropolitan Toronto and Blue Cross-Blue Shield of Massachusetts.

Interest in less expensive methods of diagnosing sleep apnea is growing because of the high cost of testing large numbers of patients. Experts estimate that up to 4 percent of all middle-aged men and 2 percent of middle-aged women—more than the percentage of people who have asthma—have sleep apnea. People with this disorder usually experience tiredness, fatigue, irritability, and difficulty concentrating. Worse still, they are more likely to fall asleep at inappropriate times and have a higher rate of vehicular crashes and work-related accidents than other people.

Sleep apnea also affects the cardiovascular system. It is associated with increased blood pressure and cardiac arrhythmias during sleep, and it may contribute to myocardial ischemia and even myocardial infarction in people with underlying cardiovascular disease. MetaWorks' systematic literature review also found some evidence, in a relatively small number of patients, that a full PSG may not be necessary to diagnose sleep apnea. In addition, oximetry—measurement of the arterial blood's oxygen saturation—performed in a sleep laboratory, chest and abdominal respiratory movements, and airflow alone (partial channel polysomnography) may have sufficient sensitivity and specificity when used with people suspected of having obstructive sleep apnea.

There is still insufficient evidence that any multichannel portable device can be used reliably to diagnose sleep apnea in a home setting. Other approaches used to aid in diagnosing sleep apnea—including neck circumference and other body measurements; ear, nose, and throat and dental assessments; radiologic exams including computerized axial tomography and magnetic resonance imaging—remain controversial.

The conclusions about the accuracy of methods for diagnosing or screening for sleep apnea were based on 71 analyzable studies, involving 7,572 patients, published between 1980 to November 1, 1997. The draft report was peer-reviewed by American and Canadian experts representing consumer groups and health care professions including neurology, pulmonary/respiratory disease, dentistry, otolaryngology, epidemiology, and nursing and by the American Sleep Disorders Association, American Sleep Apnea Association, and the American Academy of Neurology.

Select to access the report's summary online. Print copies of the summary of Evidence Report Number 1, Systematic Review of the Literature Regarding the Diagnosis of Sleep Apnea (AHCPR 99-E001), are available from the AHCPR Publications Clearinghouse. The full report will be available in print (AHCPR Publication No. 99-E002) and online in the near future.

Rehabilitation for Traumatic Brain Injury. More research is needed on the effectiveness of rehabilitation for traumatic brain injury (TBI), according to an exhaustive analysis of the scientific literature by the Oregon Health Sciences University (OHSU) EPC. The year-long study found no strong evidence supporting one rehabilitation strategy over another.

TBI can occur as a result of motor vehicle accidents, gunshot wounds, falls, and other traumas to the head. Advances in medical technology and improvements in regional trauma services have increased the number of survivors of TBI. Each year, about 80,000 TBI survivors will have some disability or require increased medical care, leading to annual direct medical costs of an estimated $48.3 billion (including the costs of acute care hospitalization and the costs of various rehabilitation services).

In conducting its analysis, OHSU explored five research questions related to the phases of recovery from TBI in adults. The questions address the timing of interdisciplinary rehabilitation; the intensity of inpatient interdisciplinary rehabilitation; the effectiveness of cognitive rehabilitation; the use of supported employment (on-site aid and advocacy at the place of employment, with the goal of enabling people with severe or long-term or permanent deficit to resume a productive life); and the provision of long-term care coordination (case management). OHSU's main findings are:

• There is evidence that a form of cognitive rehabilitation which provides environmental cues and assistance (for example, personally adapted electronic devices to provide reminders to perform certain tasks) improves everyday memory function and that other forms reduce anxiety and improve self-concept and relationships.
• Although the evidence is weak, it may be of benefit to patients, the health care system, and payers to initiate coordinated, multidisciplinary rehabilitation for patients with severe TBI as soon as possible after their admission to the trauma center.
• There is insufficient evidence on which to base decisions regarding the application of intensive inpatient rehabilitation. Currently, studies use "number of hours of therapy" as a measure of treatment intensity, which does not take into account the quality or productivity of each session. A better measure of intensity must be developed, and new studies should be conducted to address this issue.
• Supported employment appears to be a promising way to increase the success of survivors of TBI in the workplace, but the studies do not give definitive proof of its effectiveness and do not provide enough clarity on why it works or its best application and use.
• At this time there is no clear research evidence for or against the effectiveness of case management for people with TBI and their families.

This study demonstrates that the present state of research in traumatic brain injury is rather weak. In terms of practice, it is not possible to state that any one treatment approach is markedly superior to another. Most treatments appear to have some beneficial effect, according to Randall M. Chesnut, M.D., principal investigator for the project. The major implication of this study is that all those involved in TBI rehabilitation—including caregivers, payers, and government agencies—must work together to improve ongoing research efforts so that future evidence-based reviews will not find similar shortcomings.

According to John M. Eisenberg, M.D., AHCPR's Administrator, the evidence presented in this report already is being translated into improved medical practice by the International Brain Injury Association as it develops TBI guidelines for children and adolescents and by the National Institutes of Health (NIH) Consensus Development Conference.

Select to access the summary of the report online. Print copies of the summary of Evidence Report Number 2, Rehabilitation for Traumatic Brain Injury (AHCPR Publication No. 99-E005), are available from the AHCPR Publications Clearinghouse. The full report (AHCPR Publication No. 99-E006) will be available in print from the AHCPR Publications Clearinghouse and online early in 1999.

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