Session E: Ethical Issues in Health Care Delivery

Moderator: Lynn Kazemekas, Ed.D., AHCPR
Panel members: Philip J. Boyle, Ph.D., Park Ridge Center, Chicago; James E. Sabin, M.D., Harvard Center for Ethics in Managed Care

Physicians' Use of Outcomes Data: Moral Conflicts and Potential Resolutions—Philip J. Boyle, Ph.D.

The Hastings Center conducted a 2-year study on how physicians receive and use outcomes data and practice guidelines. Evidence has shown that outcomes data and practice guidelines improve quality of care, yet physicians sometimes ignore them. If managed care requires physicians to rely on outcomes data and guidelines, problems may arise when they decline to follow them.

At four medical centers in different geographic areas, each with a diverse patient population, the study addressed the following questions: (1) Are physicians aware of outcomes data and practice guidelines? (2) Have their institutions begun to use them? (3) Are physicians paying attention to them? and (4) What are physicians' hesitations in using them?

Three categories of objections were raised against the use of outcomes data and practice guidelines:

• Physicians disputed the reliability of data or the objectivity of the practice guideline panel.
• Physicians found the data reliable, but overrode the data because of a patient's request, the inapplicability of the data, or the fear of a lawsuit.
• Physicians had undefined motivations (both professional and technology specific) that require further study.

Another example of physician objection to the use of guidelines was found in the GUSTO (Global Utilization of Streptokinase and t-PA for Occluded Coronary Arteries) trial. Here, physicians were concerned with biased and defective methodology.

Physicians may object to using a guideline for moral reasons if recommendations that are implicit or explicit in the document are based on the values of those who developed them. An option for avoiding "value-driven" inferences is to publish data without any recommendations. Doctors will not resist for moral reasons if only facts are presented, but their use of the data may be limited. Alternatively, the author of a guideline document could acknowledge that it may contain embedded values and attempt to persuade the physician to follow the guideline nevertheless.

Physicians may have other reasons for ignoring outcomes data and guidelines, such as when outcomes data do not show an effect. In such situations, three options are available:

• Defer to the patient. Giving the patient the recommendations eliminates physician resistance to guidelines.
• Create constraints or incentives by lowering reimbursements when physicians ignore outcomes data or practice guidelines.
• Remove the physician from the decisionmaking process.

The following conclusions resulted from the study:

• The integrity of the physician is important: many will resist using outcomes data and practice guidelines if they feel overly pressured or believe their own qualifications surpass the guidelines.
• Although outcomes data and practice guidelines promote the best practices, the risk of overcompliance has not yet been studied.
• When the staff of HMOs and managed care organizations regularly refer to practice guidelines, they tend to understand them better and are thus more likely to follow them.
• Physicians do not always read outcomes data and guideline documents because of the overwhelming amount of information presented in them. Doctors often make judgments without reading them.
• Physicians need rules on when deviation from outcomes data is acceptable.

Insurance Coverage for Promising But Unproven Last Chance Therapies: Ethical Issues and Practical Policies—James E. Sabin, M.D.

Treatments that might save, prolong, or improve life, but have not been proven to work can pose a dilemma for the policymakers of insurers and managed care organizations. If a treatment proves effective, withholding it can lead to premature death or harm, which violates the physician's fidelity to the patient. Conversely, if the treatment is ineffective, using it squanders resources.

In 1991, Aetna developed a policy to manage decisions about unproven cancer treatments. Under this policy, a request for an unproven treatment is channeled through headquarters to a suitable specialist. If appropriate, the request is referred to an organization called the Medical Care Ombudsman Program (MCOP). The program forms a panel of experts experienced in the particular clinical area who have no attachment to the insurer or the health care delivery site. If any of the experts consider the treatment appropriate, Aetna will cover it. MCOP determines only if a treatment is appropriate, but does not make treatment recommendations.

In 1994, Northern California Kaiser Permanente instituted a program for unproven but promising last-chance technologies. Kaiser does not authorize its physicians to prescribe questionable treatments, so patients are guided through a series of consultations within the organization. Should the patient and family be dissatisfied with the outcome of the internal consultations, Kaiser offers a consultation or appeal outside the organization, a policy that triggered much internal controversy. In 3 years, with a patient base of 2.5 million, only 6 consultations went outside the organization. The Kaiser staff observed that when the concerns of all parties are adequately addressed, a collaborative outcome can usually be reached.

The Oregon Blue Cross/Blue Shield (BC/BS) approach to policymaking in this area was to create the role of transplant coordinator, a skilled individual who functions as a pre-problem ombudsperson. If a patient is in a last-chance situation, the coordinator interfaces between the patient, doctors, providers, and clinical researchers to find a solution. Oregon BC/BS is committed to covering unproven treatments if they are part of a medical trial and will go to great lengths to find such a trial. The organization does not pay for an unproven treatment that is not part of a trial. 

In conclusion, three key values are at stake in managing last-chance health care: fidelity to the patient, stewardship, and science (which is attached to evidence). Additionally, motivation, integrity, and reliability of both the data and those who use it are important issues for guidelines and policy decisions. Last-chance technologies can serve as a good litmus test for collaborative decisions and informed consent. The above examples show that when insurers address patient concerns, ethical managed care is possible.

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Session F: Evidence-based Medicine: Implementation in Managed Care—Lessons Learned

Moderator: David Atkins, M.D., AHCPR 
Panel members: Ronald J. Gebhart, M.D., Division of Primary Care, Department of Veterans Affairs; Marianne Laouri, Ph.D., PacifiCare, Washington; and George Isham, M.D., HealthPartners, Minneapolis.

Translating Evidence into Practice at the Department of Veterans Affairs—Ronald J. Gebhart, M.D.

The Department of Veterans Affairs (VA) seeks to provide quality care by functioning as an integrated health system, that includes primary, specialty, and extended care as well as social support. The VA provides care to more than 3 million military-connected individuals annually.

At the recommendation of the VA Undersecretary for Health, the VA is developing and adopting guidelines to improve consistency and effectiveness of treatment in this very large system. In 1996, 22 VA clinics served as pilot sites for guideline development. Steps were taken to maximize the acceptability and implementation of the guidelines, once developed or adopted. Each was tested in one site for a 6-month period before nationwide implementation. Local modification to promote "buy-in" was encouraged, as long as it did not violate the scope of the guideline.

Guidelines developed June 1996 through April 1997 cover many conditions. Covered conditions include: stroke, amputation, ischemic heart disease, major depressive disorder, major depressive disorder with post-traumatic stress disorder, major depressive disorder with substance abuse, dementia, diabetes mellitus, and psychosis. Since then, the VA sites have been developing guidelines on Helicobacterpylori, prostate disease, asthma, anxiety, degenerative joint disease, and gout.

In addition, pharmacologic treatment guidelines were completed in December 1996 for chronic obstructive pulmonary disease, HIV/AIDS, hyperlipidemia, hypertension, and non-insulin dependent diabetes. Currently in the works are pharmacologic guidelines for congestive heart failure, depression, peptic ulcer disease, glaucoma, benign prostatic hypertrophy, and degenerative joint disease.

Guidelines already developed by other agencies or organizations were adopted for many conditions. For example, treatment guidelines for HIV were adopted from AHCPR, and guidelines for cancer staging were adopted from the American Cancer Society. 

Currently, data are being collected on potential improvement in patient outcomes; results will be available soon.

Translating Evidence into Practice at PacifiCare, Washington—Marianne Laouri, Ph.D.

PacifiCare, a network-model managed care organization (MCO), serves 3.5 million members. With competing needs for its limited resources, PacifiCare must measure and improve care effectiveness. Company-wide quality improvement programs attempt to do so under the direction of Quality Measurement and Research unit. In December 1996, the Quality Initiatives Selection Committee, which was made up of employers, providers, medical directors, and community members, selected the following areas for measurement and improvement: maternal and child health, diabetes management, cardiovascular health, and depression. Baseline data were collected for each area, including clinical, administrative, and survey data. National guidelines were implemented for each area, and followup data will be collected 1 year later to determine the impact of the guidelines on quality of care.

The nationally implemented guidelines sometimes conflicted with locally developed guidelines. At such times, feedback from physicians helped make the national guidelines more user-friendly. The eventual success of national guideline implementation yielded several conclusions: (1) local standards of care are not needed, (2) evidence-based guidelines can be used to increase consistency of care, and (3) existing measures and guidelines can be used for quality improvement, even in a large MCO or HMO.

Translating Evidence into Practice at HealthPartners, Minneapolis—George Isham, M.D.

HealthPartners is a not-for-profit group of 550 physicians who participate in an integrated system of research, managed care, clinical care, training of medical personnel, and development of practice guidelines and technology assessments. The philosophy of the system is to maximize communication and cooperation among the various groups.

Guidelines are developed through the Institute for Clinical Systems Integration. Physicians are recruited to choose topics, examine evidence, draft guidelines, and pilot test them. Then begins an improvement cycle in which baseline and followup measures of treatment effectiveness are gathered and compared. Buyers of health plans or employers sit on the Institute board and send representatives to join guideline committees to provide the employers' perspectives.

Lessons learned to date in this process include the following:

1. Physician involvement is crucial if physicians are to be comfortable with adopting the guidelines.
2. The marketplace must be right for successful implementation.
3. Participation by purchasers and patients is practical and valuable.
4. Guideline implementation is difficult and should begin in appropriate service areas.
5. Measuring for improvement is unfamiliar to many.
6. Annual review and revision by physicians is recommended.

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Session G: Using Information Systems to Support Evidence-based Practice

Moderator: Tina Murray, R.N., M.A.S., AHCPR 
Panel members: J. Michael Fitzmaurice, Ph.D., Center for Health Information Technology, AHCPR; Cary Sennett, M.D., Ph.D., National Committee on Quality Assurance; and Peter McMenamin, Ph.D., Lewin Group

Using Information Systems to Support Evidence-based Practice—J. Michael Fitzmaurice, Ph.D.

The quality and cost of patient care can be improved by using information technology to link patient information and medical knowledge. AHCPR supports research that identifies productive uses of information technology; measures its benefits and costs; analyzes the impact on quality, cost, and access; and identifies the barriers to information technology use. It also investigates how information technology supports the changes occurring in our health care delivery system.

Providers resist computerization. Much of the clinical information needed for evidence exists only on paper. Systems are not interoperable; for example, a hospital pharmacy system is not linked with the radiology system or with the nursing station. Instead, computer information is printed out and added to the patient's paper record.

Privacy of electronic medical information is of major concern. Debate is ongoing now about use of unique patient identifiers in place of individual names. The Social Security number, however, can link health information with employment records or Internal Revenue Service records. Concerns to protect proprietary data are another part of the reality. Data warehouses (e.g., inside a hospital or managed care organization) provide market power, because they can be used to assess the impact of the organization's services.

Patients' rights are not yet defined in regard to access to and use of their medical records. This is now being debated in Congress in discussion of the Federal Privacy Law. Currently, the owner or holder of a record controls its use within the scope of that organization's policy, within the scope of the patient's authorization, and within the State's law. This limits use by accreditors of organizations, institutions, and providers; uses by researchers; and uses by public health policymakers—all of whom collect evidence-based information to supply it to decisionmakers.

Research on information technology in health care has shown that physicians who receive computerized prompts on ordering tests and drugs change their ordering behavior, thereby reducing costs without any apparent reduction in quality of care. Adverse drug events can be detected and reduced. On the other hand, do-not-resuscitate orders in Living Will prompts often are not carried out. Preventive service reminders for hospital inpatients are not very effective.

Barriers to using medical information systems include different code vocabularies (code systems for recording patients' presenting conditions, physician diagnoses, physicians' treatment, and patient outcomes are lacking); privacy, confidentiality, and security (no Federal laws, only a few State laws); lack of obvious productivity gains in individual physician practices; and education and training needs much greater than expected. 

A 3-year AHCPR program, Computerized Decision Support Systems (CDSSs) for Health Providers, is investigating how to link guideline/evidence-based information with patient data and bring all to the attention of the physician and the patient at the time decisions are made. Three focal points are (1) using guidelines in CDSSs while maintaining confidentiality of patient care data; (2) looking at the impact of CDSSs on the patient care process, outcomes of care, and costs of care; and (3) identifying and testing factors that influence practitioner use of CDSSs. Specificity of guidelines should be improved, perhaps through evidence reports.

Implementing Guidelines in Systems of Care—Cary Sennett, M.D., Ph.D.

The National Committee on Quality Assurance (NCQA) is a not-for-profit nongovernmental evaluator of managed care plans serving as a source for public information on their quality and performance. The performance measurement program, Health Plan Employer Data and Information Set (HEDIS), is a set of standardized performance measures for assessing important results achieved by health plans. It contains information on immunization of children, adolescents, and the elderly; mammography, Pap tests, and diabetic screening rates; use of beta-blockers after acute myocardial infarction; and use of appropriate antibiotics in children with otitis media. HEDIS is now being revised.

The NCQA Information Systems Work Group was formed to communicate with the managed care industry on ways to upgrade its information systems to achieve optimum performance measurement. To assess the gap between current information systems environments and NCQA's envisioned goal, NCQA conducted more than 60 interviews with members of the managed care industry. A report on this effort is titled the "Information Systems Road Map" (and now included in the latest HEDIS version). The report contains precise recommendations to encourage the industry over a period of 3 to 5 years to achieve more capable information systems. The recommendations detail seven elements that should compose the framework of an information system:

1. Data, including demographic characteristics of enrollees, important diseases, previous history, and physical findings; results of diagnostic tests and procedures; therapeutic procedures; medications; baseline and serially assessed functional/health status; patient and provider experiences of care; treatment-related morbidity; and mortality.
2. Linkages, consisting of communications links among data repositories; contracts that permit access; rapid merging capability; and reduction of duplicate data entry and storage.
3. Standardization, which involves unique identifiers, standard definitions of all terms; universal medical record structure; code mapping, and messaging and data transfer standards.
4. Data quality, achieved through verification and audit methods and data quality improvement methods.
5. Confidentiality and security, a matter of great public concern, controlled by means of strict limitation of access.
6. Automation, through which to create the electronic medical record. This goal of the electronic medical record is seen as a long-range goal, given the financial barriers.
7. Data-sharing capability, which must be increased among health plans, providers, and databases of public health agencies (e.g., linking a health plan dataset to a SEER dataset using a common identifier). To this end, Internet technology could be put to use.

The benefits resulting from improved information systems are that patient needs can be identified more effectively; best practices can be identified and transferred; decision support tools for providers can be implemented; recordkeeping efficiency and effectiveness can be improved; resource management can be improved; and inappropriate variations in service can be reduced.

How Does Practice Translate Into Evidence?—Peter McMenamin, Ph.D.

Electronic claims data are being used to examine patterns of treatment practice, and allow conclusions derived from this information to be translated into evidence. Existing datasets can be used to examine and document current patterns of practice; the results are then fed back into improvements in performance. Patterns of practice can be translated into cost-of-illness studies (costs to treat persons with certain diagnoses or using certain procedures). Work can be done now on interim outcomes, that is, short-term impacts that can be inferred by a continuing pattern of receipt of services (or lack of additional services). Analysis of many records reveals patterns of practice that can be used as benchmarks—how people actually are being treated.

The largest source of data is the physician dataset (which also might include ambulance drivers, laboratories, and medical equipment suppliers). The most conventional record in use by providers is the HCFA 1500. Hospital claims data are the second largest source, and another large dataset comes from pharmacy claims.

A linked set of records has more value than a single record to illustrate common diagnoses and subdiagnoses and services that seem to follow one another or be associated with one another. Occasionally a record does not fit into discovered patterns and can be dismissed. Linking records requires common elements such as: patient elements such as a nominal ID, the time of birth or age, gender, and sometimes race (patient health status, clinical content, and health history are usually missing); physician elements including a nominal identifier such as a TIN, a medical record number, or a license number; hospital elements from hospital datasets or individual State files to identify the hospital's facilities; information on pharmacies as providers; and insurance claims data.

Identifying from claims data the services being provided to patients is a challenge. In the United States, an extensive nomenclature is used to code physician services—CPT. Procedure codes in IC and ICM are much less specific than CPT and correspond only roughly. National Drug Code (NDC) codes are a very detailed set of nominal identifiers; each code has two parts—one for the manufacturer identity and the other for the drug (a sequence number). These codes are difficult to use because therapeutic class cannot be determined from the code. Diagnosis-related groups (DRGs) are used in hospitals but do not reveal much information on services.

Diagnosis data are coded in many ways, depending on how data are entered, what the insurer requires, how the patient presents, and whether the physician is trying to rule out some alternative condition. Patterns of diagnoses yield useful evidence. It is important to remember that any one patient may have several diagnoses at the same time, particularly in Medicare, the source of the best dataset.

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