Obtaining the information listed above and making it available to consumers will not, by itself, equip consumers with the knowledge and abilities required to act on this information. Discussed below are some basic considerations in making this information useful to consumers and the implications of this for key segments of the health care industry.

Information Should Be Useful to Consumers and Cost Effective to Obtain. Edgman-Levitan and Cleary (1996) have documented that consumers are able to evalute critical information about quality. However, research on how consumers use information to make decisions suggests that too much information can be overwhelming. In its 1988 assessment of methods for commmunicating the quality of medical care to consumers, the Office of Technology Assessment's Expert Advisory Panel concluded that "limiting information to only a few indicators of quality will probably be necessary [because] people can consider only a few items at any one time. Information is processed as a unit or chunk -- a person's processing capacity has been estimated as being anywhere from four to seven chunks" (OTA, 1988). Ongoing research must be conducted to determine what is the most effective subset of information that consumers can use. Finally, while consumers clearly have a right to information, it must be understood that there are costs associated with collecting and distributing it. While providing information to consumers generates significant benefits for both the consumers and the health system as a whole, it is not necessarily inexpensive. Recognizing these costs, however, is not an argument for a "bare bones" approach to information disclosure. The failure to provide information also has costs. Well-informed consumers are the bedrock of an efficiently operating market. Without meaningful information, consumers are more likely to make choices that can result in less than optimal outcomes for themselves and there is less incentive for participants to strive for excellence. The challenge is to develop coordinated approaches to information collection and dissemination that will provide consumers the information they need to make decisions without imposing severe burdens on plans and providers.

Investments in Clinical Information Systems and Workforce Education and Training Will Be Needed. Greater investment in automated information systems will be necessary for health plans and providers to satisfy these information disclosure requirements, especially ones pertaining to product, facility, and provider performance and quality. The Commission is currently assessing barriers or impediments to investment in clinical information systems (e.g., inadequate data collection standards; confidentiality concerns; magnitude of capital investments required) and plans to speak to this issue in its final report. Responding to these increased information demands also has implications for the training and education of the health care workforce. There will be greater demand by health care organizations for individuals with particular technical and analytic skills (e.g., computer programming, engineering, data auditing, and statistics). Ongoing training and continuing education programs for practitioners and other workers whose work involves recording, compiling, or manipulating clinical and administrative data will also be needed to assure the completeness and accuracy of data and adherence to confidentiality safeguards.

Beauchamp TL, Childress JF. Principles of Biomedical Ethics (New York): Oxford University Press; 1994.

Darling H. Xerox Corporation. testimony before the Advisory Commission on Consumer Protection and Quality in the Health Care Industry, May, 1997.

Edgman-Levitan S, Cleary S and P. "What Information Do Consumers Want and Need: What Do We Know About How They Judge Quality and Accountability?" in: Jones SB, Lewin ME, editors, Improving the Medicare Market: Adding Choice and Protections, Washington, DC: National Academy Press; 1996.

Harvard Pilgrim Health Care. telephone conversation with Janice Boyce, Public Affairs Department, August 25, 1997.

Office of Technology Assessment. The Quality of Medical Care: Information for Consumers, No. OTA-H-386. Washington, DC; 1988.

Oxford Health Plans. telephone conversation with Scott Schwartz, Assistant General Counsel, August 25, 1997.

Sofaer S. "How Will We Know If We Got It Right? Aims, Benefits and Risks of Consumer Information Initiatives," The Joint Commission Journal on Quality Improvement, May 1997; 23(5):258-264.

Health plans should educate their members about the availability, location, and appropriate use of emergency and other medical services; cost-sharing provisions for emergency services; and the availability of care outside an emergency department.

Health plans using a defined network of providers should cover emergency department screening and stabilization services both in network and out of network without prior authorization for use consistent with the prudent layperson standard. Non-network providers and facilities should not bill patients for any charges in excess of health plans' routine payment arrangements.

Emergency department personnel should contact a patient's primary care provider or health plan, as appropriate, as quickly as possible to discuss follow-up and post-stabilization care and promote continuity of care.

In 1995, Americans paid an estimated 96.5 million visits to emergency departments, nearly 37 visits per 100 persons (Stussman, 1997). By tradition, emergency departments (EDs) have handled a spectrum of illness, but have had the primary mission of treating those with acutely serious, even life-threatening, medical conditions. Emergency services can be defined as services that are needed or appear to be needed immediately because of injury or sudden illness that threatens serious impairment of any bodily function, and/or serious dysfunction of any bodily organ or part.

Patients go to the emergency department with nonurgent problems for various reasons. Economic and geographic barriers to other forms of care, the lack of a regular provider, and other factors can and do prompt patients to turn to the emergency department for primary and other nonurgent care. Apart from lack of health insurance coverage, nonfinancial barriers to primary care encourage patients to seek evaluation and treatment in the ED. These include problems with work schedules, access to transportation, and concerns about personal safety (Rask, Williams, Parker, et al., 1994). Physician offices and primary care clinics often have limited hours of operation, while EDs are open 24 hours a day. Medicaid beneficiaries, who have a history of limited access to regular providers, have particularly strong relationships with EDs as the provider of first and last resort. Nonurgent visits to the ED can be costly, contribute to overcrowded waiting rooms, divert resources away from other hospital-based care, and compromise the coordination and continuity of care.

But drawing the line between urgent and nonurgent use of the ED is not an easy decision for providers, health plans, and consumers. Criteria -- both prospective and retrospective -- for appropriate ED use are in many ways inadequate. By one criterion, a patient's ED visit might be deemed appropriate, and by another, not so (Lowe and Bindman, 1997). Health care professionals do not agree among themselves about the need for urgent care among emergency department patients (Gill, Reese, and Diamond, 1996). In a survey of 56 hospital EDs, 5.5 percent of patients initially classified by triage nurses as nonurgent were later admitted to the hospital from the ED (Young, Wagner, Kellerman, et al., 1996). Studies estimate that those presenting with nonurgent problems to the ED range from 6.3 percent (Cunningham, Clancy, and Cohen, et al., 1995) to 54.2 percent (Stussman, 1997) of ED visits.

To better manage care and costs in the ED setting, indemnity and managed care plans use a range of tools that includes requirements for prior authorization and imposition of higher cost-sharing for use of out-of-network emergency departments. A 1989 survey of HMO medical directors found coverage policies for ED use across the HMO industry to be fairly uniform (Kerr, 1989). Unless the condition is life-threatening, patients must obtain prior authorization before seeking emergency care services in 80 percent of the responding HMOs, and 38 percent limited their coverage to the EDs of selected network hospitals. A study undertaken by the Center for Health Policy Studies shows that private indemnity insurers have adopted many of these same practices in their fee-for-service arrangements (PPRC, 1996).

A growing set of State and Federal laws and regulations clarify and protect consumers' access to appropriate emergency services. The Emergency Medical Treatment and Labor Act (EMTALA) requires all Medicare participating hospitals to evaluate whether a patient has an emergency medical condition and, if so, to stabilize the patient. The Balanced Budget Act of 1997 requires health plans participating in Medicare or Medicaid to reimburse for emergency services using a "prudent layperson" standard. Numerous States also have adopted this standard for access to emergency services. The Commission's recommendation seeks to create uniformity in all States.

Health care providers. Health care providers will need to work to educate consumers about the appropriate use of emergency department services while working to increase the hours and locations of primary care clinics and other facilities to ease access to such services outside of emergency departments. Emergency department personnel need to make strong efforts to ensure the continuity of care of emergency patients by communicating with patients' primary care providers. Efforts should be made to assist consumers with language, communication, or other barriers.

Health plans. Health plans need to expand consumer education efforts and, when it is within their control, expand hours and location of primary care facilities to facilitate access to such services outside of emergency departments. Plans need to ensure that their coverage and payment policies are consistent with the "prudent layperson" standard.

Consumers. Consumers need to become more familiar with the location and hours of nonemergency care settings and strive to make greater use of such facilities when appropriate. Consumers should communicate with their providers and plans to understand any restrictions on their access to emergency services.

Cunningham PJ, Clancy CM, Cohen WJ. "The Use of Hospital Emergency Departments for Nonurgent Health Problems: A National Perspective." Med Care Res Rev 1995; 52(4):453-474.

Gill JM, Reese CL, Diamond JJ. "Disagreement among Health Care Professionals about the Urgent Care Needs of Emergency Department Patients." Ann Emerg Med 1996; 28(5):474-479.

Kerr HD. "Access to Emergency Departments: A Survey of HMO Policies." Ann Emerg Med 1989; 18(3):274-277.

Lowe RA, Bindman AB. "Judging Who Needs Emergency Department Care: A Prerequisite for Policy-Making." Am J Emerg Med 1997; 15(2):133-136.

Physician Payment Review Commission. Managing Medicare's Fee-for-Service Program. 1996 Annual Report to Congress. Washington, DC: PPRC; 1996; 196-199.

Rask KJ, Williams MV, Parker RM, et al. "Obstacles Predicting Lack of a Regular Provider and Delays in Seeking Care for Patients at an Urban Public Hospital." JAMA 1994; 271:1931-1933.

Stussman BJ. National Hospital Ambulatory Medical Care Survey: 1995 Emergency Department Survey. Advance Data from Vital and Health Statistics (no. 285). Hyattsville, MD: National Center for Health Statistics; 1997.

Young GP, Wagner MB, Kellermann AL, et al. "Ambulatory Visits to Hospital Emergency Departments: Patterns and Reasons for Use." JAMA 1996; 276:460-465.

Provide patients with easily understood information and opportunity to decide among treatment options consistent with the informed consent process. Specifically,

Discuss all treatment options with a patient in a culturally competent manner, including the option of no treatment at all.

Ensure that persons with disabilities have effective communications with members of the health system in making such decisions.

Discuss all current treatments a consumer may be undergoing, including those alternative treatments that are self-administered.

Discuss all risks, benefits, and consequences to treatment or nontreatment.

Give patients the opportunity to refuse treatment and to express preferences about future treatment decisions.

Discuss the use of advance directives -- both living wills and durable powers of attorney for health care -- with patients and their designated family members.

Abide by the decisions made by their patients and/or their designated representatives consistent with the informed consent process.

To facilitate greater communication between patients and providers, health care providers, facilities, and plans should:

Disclose to consumers factors -- such as methods of compensation, ownership of or interest in health care facilities, or matters of conscience -- that could influence advice or treatment decisions.

Ensure that provider contracts do not contain any so-called "gag clauses" or other contractual mechanisms that restrict health care providers' ability to communicate with and advise patients about medically necessary treatment options.

Be prohibited from penalizing or seeking retribution against health care professionals or other health workers for advocating on behalf of their patients.

Consumers depend on health care professionals to provide them with expert consultation and advice on how to stay healthy or how to cure or palliate their health and medical problems. Unlike many other consumer transactions, the asymmetry of information between consumer and health care provider often is great. Decisionmaking also often occurs at a time of illness, which can undermine the patient's ability to act most effectively in his or her own interest.

Relationships between consumers and health care professionals are most rewarding and likely to result in positive outcomes when they are characterized by open communication and active participation of patients in the treatment process. Patient participation in treatment is an essential part of compliance, and compliance improves the effectiveness of care and treatment.

The benefits of patient participation go beyond just the anticipated therapeutic effect of the intervention (Czajkowski and Chesney, 1990). For example, the Coronary Drug Project Research Group (1980), which studied the efficacy and safety of several lipid-lowering drugs, found that even among patients who only took placebos, good adherers had a much lower 5-year mortality rate (15 percent) than did poor adherers (24.6 percent).

Patient participation in treatment decision making also leads to improved satisfaction with care and better quality of life. For example, in a study of patients with early breast cancer, it was found that those who believed they were more responsible for treatment decisions and had more choice of treatment reported higher quality of life than those who perceived themselves as less in control of the treatment decisions (Street and Voigt, 1997).

To participate in decisionmaking about their care, consumers must have complete information about treatment options -- including the alternative of no intervention -- as well as the risks, benefits, and consequences of such options. Yet evidence suggests that clinical practice often falls short of these expectations. A 1988 study of hospitalized patients found that physicians discussed test or treatment rationale in only 43 percent of cases and alternatives in 12 percent of cases (Wu and Pearlman, 1988). Physicians shared with patients information about benefits in 34 percent of cases and risks in 14 percent of cases.

The continued development of communications technologies to help consumers more fully understand their treatment options and to evaluate the potential risks and benefits of treatments should be encouraged, for example, the use of videos to help men with prostate cancer evaluate the risks and benefits of surgery versus a "watchful waiting" strategy (Wennberg, 1995) and to help men with benign prostatic hypertrophy sort out options for treatment (Wagner et al., 1995).

Increasingly, effective communication between providers and patients demands some degree of cultural competence. By the year 2000, nearly one-quarter of the U.S. population will be members of racial or ethnic "minority" groups; this will grow to 47.5 percent by the middle of the next century. Cultural competence refers to the "demonstrated awareness and integration of three population-specific issues: health-related beliefs and cultural values, disease incidence and prevalence, and treatment efficacy" (Lavizzo-Mourey and Mackenzie, 1996). Effective communication for people with communication disabilities may require health care providers to provide auxiliary aids and services and remove certain communication barriers.

It also is imperative that providers be aware of and comply with their patients' decisions with respect to advance directives. Once a patient makes a decision, the health care team should respect this treatment choice. Yet there is clear evidence that this is not happening in far too many instances. Teno et al. (1995) studied 4,301 patients hospitalized in 6 hospitals and found that physicians often were unaware of their patients' wishes. In 47 percent of cases, physicians reported that they did not know of their patients' expressed desire for a "do not resuscitate" order. In another study focusing on nursing home residents transferred to hospitals, Davis, Southerland, Garrett, et al. (1991) found that medical treatment was consistent with advance directives in 75 percent of the 96 cases studied.

There are a variety of organizational and contractual factors that also may influence communication between patients and providers. These include financial arrangements and contractual restrictions or sanctions that may inhibit the free exchange of information.

Much attention has focused in recent years on the potential effects of providers' financial incentives on treatment. Methods of compensating physicians can be a powerful mechanism to change provider practice, either to improve the quality of care provided to consumers or to reduce the costs of that care. But poorly designed compensation arrangements also can result in inappropriate use (including both overuse and underuse) and barriers to care.

All methods of compensating physicians and other health care providers create some form of incentive for behavior. Various approaches are used to offset the potential adverse effects of compensation arrangements. For example, fee-for-service systems may use utilization review mechanisms to temper incentives toward overutilization of health care services. Capitation systems may incorporate measures of quality and consumer satisfaction to minimize incentives toward overutilization. Similarly, salaried arrangements may use bonuses to encourage higher provider productivity and exemplary performance.

In 1996, the Health Care Financing Administration promulgated rules concerning the use of certain types of financial arrangements on behalf of health plans serving Medicare or Medicaid beneficiaries. These rules stipulate that compensation arrangements "may not include any direct or indirect payments to physicians or groups as an inducement to limit or reduce necessary services furnished to an individual enrollee who is covered under the managed care organization's contract." These regulations also require disclosure of information about arrangements that transfer substantial financial risk to the health care provider. If the compensation methods used places the physician or physician group at substantial financial risk, then the health plan must survey enrollees about access and satisfaction with the quality of services, and institute adequate and appropriate stop-loss protections.

In addition to financial incentives, contract rules that restrict providers' ability to advise patients about medically necessary treatment options have been the subject of much concern. Health care providers must be able to advocate for their patients without constraint or fear of reprisal. A report by the General Accounting Office (GAO, 1997) reported: "Of the 529 HMOs in our study, none used contract clauses that specifically restricted physicians from discussing all appropriate medical options with their patients. Two-thirds of responding plans and 60 percent of the contracts submitted had a nondisparagement, nonsolicitation, or confidentiality clause that some physicians might interpret as limiting communication about all treatment options. However, contracts with such business clauses often contained anti-gag language stating that the physician should not misconstrue the contract of a specific provision as restricting medical advice to patients or that the physician should foster open communication." As of mid-1997, 25 States had prohibited the use of such clauses in managed care contracts with physicians and legislation was pending in 23 other States (Health Policy Tracking Service, 1997). In December 1996, HCFA banned the use of gag rules under the Medicare program and in February 1997, HCFA took similar action regarding health plans' participating in Medicaid.

Consumers must take a more active part in the treatment decision process. Information can be empowering, but navigating the health care system requires patient effort, from completing advance directives to preparing questions for an office visit. This requires that the consumer ask questions, understand and give informed consent, and become a full partner in treatment decisions with his or her health care provider.

Health care providers also have the central role in ensuring the patient's participation in treatment decisions, including compliance with informed consent. They will need to improve their skills in providing information about the medical and scientific evidence underlying different treatment options to patients and their families; strive to overcome cultural and language and communication barriers; and keep abreast of the latest and best available treatment options. At the same time, they will need to do a better job of listening to their patients and following their decisions, including the decision to forgo treatment or certain types of treatment. Health care providers should assume this responsibility well before a patient reaches a hospital door. To hold the trust of patients, providers will need to disclose financial incentives that may introduce bias into treatment decisionmaking and to avoid such incentives when the balance is tipped against the patient. To be above any potential bias, providers must avoid self-referral arrangements that can cloud their professional judgment. And, finally, health care providers are and should be the most effective advocates for their patients' rights.

Health care facilities and plans must create and maintain an environment supportive of consumer participation in treatment decisions. In the office practice, this means ensuring adequate visit time for patients and providing support for shared decisionmaking programs when questions about care linger, arise after hours, or require further explanation. Health plans can play a significant role in educating patients on how to get the most out of their visit with a health care provider. They can arrange for translator services for patients and continuing education courses for providers to assure cultural and language competency. By statute, health plans and hospitals have obligations to educate the public about the use of advance directives. As importantly, once advance directives are signed, these documents must become part of the patient's health record and must move with the patient from care setting to care setting. In establishing provider compensation arrangements, health plans and facilities must be vigilant in guarding against the unintended, negative consequences of financial incentives by implementing programs to monitor quality of care and patient satisfaction. The nature of these incentives ought to be disclosed to patients and providers. In contracting with health care providers, plans and facilities should not restrict the provider's ability to discuss treatment options with the patient and not take reprisal upon the health care provider who serves as patient advocate.

Coronary Drug Project Research Group. "Influence of Adherence to Treatment and Response of Cholesterol on Mortality in the Coronary Drug Project." N Engl J Med 1980; 18:1038-1041.

Czajkowski SM, Chesney MA. "Adherence and the Placebo Effect." in Schumacher, SK, Schron EB, Ockene JK, et al., editors. The Handbook of Health Behavior Change. New York: Springer Publishing Company; 1990.

Davis M, Southerland LI, Garrett JM, et al. "A Prospective Study of Advance Directives for Life-Sustaining Care." N Engl J Med 1991; 324:882-8.

General Accounting Office. Report to Congressional Requesters. Managed Care: Explicit Gag Clauses Not Found in HMO Contracts, But Physician Concerns Remain. August 1997.

Health Policy Tracking Service. Issue Brief: Bans on Gag Clauses. April 1997.

Lavizzo-Mourey R, Mackenzie ER. "Cultural Competence: Essential Measurements of Quality for Managed Care Organizations." Ann Intern Med 1996; 124(10):919-921.

Street RL, Voigt B. "Patient Participation in Deciding Breast Cancer Treatment and Subsequent Quality of Life." Med Decis Making 1997; 17:298-306.

Teno JM, Hakim RB, Knaus WA, et al. "Preferences for Cardiopulmonary Resuscitation; Physician-Patient Agreement and Hospital Resource Use. The SUPPORT Investigators." J Gen Intern Med 1995; 10(4):179-86.

Wagner EH, Barrett P, Barry MJ, Barlow W, Fowler FJ. "The Effect of a Shared Decision Making Program on Rates of Surgery for Benign Prostatic Hyperplasia; Pilot Results. Med Care 1995; 33:765-770.

Wennberg J (Producer). Treatment Choices for Prostate Cancer [Film]. Hanover, NH: Foundation for Informed Decision Making, 1995.

Wu WC, Pearlman RA. "Consent in Medical Decision-Making: The Role of Communication." J Gen Intern Med 1988; 3:9-14.

Consumers want to be treated with respect and they want to be treated fairly. An environment of mutual respect is essential to maintain a quality health care system. Incidences of discrimination -- real and perceived -- mar the relationship between consumers and their health care professionals, plans, and institutions. Multiple consumer surveys (Levinson et al., 1997; Davis et al., 1995; Edgeman-Levitan and Cleary, 1996) have found that many consumers' complaints about the current health care system have their root in the perception that people believe they are not being treated with respect.

Respect has been defined as recognizing a "person's capacities and perspectives, including his or her right to hold certain views, to make certain choices, and to take certain actions based on personal values and beliefs" (Faden and Beauchamp, 1986). Manifestations of disrespect in the health care setting described by consumers in recent research (Levinson et al., 1997) and interviews include: poor communication with their doctor, feeling rushed or ignored, lack of dignity during examinations, experiencing extensive waiting room delays, receiving inadequate explanations or advice, having inadequate time with the doctor during routine visits, feeling that complaints are not taken seriously by providers, and feeling that providers are more concerned with holding down the cost of medical care than with giving the best medical care. Conversely, consumers defined respectful treatment as that which takes into consideration the values, preferences, and expressed needs of the patient. In addition, consumers wanted providers to communicate well, to be respectful of the patient's time, and to give emotional support to alleviate the patient's fear and anxiety.

In order to extend consumers the respect they deserve, members of the health care industry should strive to:

Provide consumers with assurances that disrespect or discrimination of any kind is intolerable.

Provide consumers with information regarding existing laws prohibiting disrespectful or discriminatory treatment.

Provide consumers with an appropriate amount of time to fully discuss their concerns and questions.

Provide consumers with reasonable assistance to overcome language (including limited English proficiency), cultural, physical or communication barriers.

Provide consumers with a timely notice and explanation of changes in fees or billing practices.

Avoid lengthy delays in seeing a patient; when delays occur, explain why they occurred and, if appropriate, apologize for such delays.

A key element of respectful and fair treatment is protection against discrimination in the delivery of health care services, and in marketing and enrollment, for those eligible for coverage under the terms and conditions of a health plan or program, based on race, ethnicity, national origin, religion, sex, age, mental or physical disability, sexual orientation, genetic information, or source of payment. Sex. Disparities in medical treatment based on sex have been documented in a number of areas, including: diagnosis and treatment of coronary artery disease (Beery, 1995), kidney transplantation and dialysis, heart transplantation, cardiac catheterization, and diagnosis of lung cancer (AMA Council on Ethical and Judicial Affairs, 1991). Researchers have found that women are less likely to have diagnostic testing, even when functional disability and risk are higher. Women's complaints are seen as less urgent, and fewer referrals follow as a result of this belief (Tobin et al., 1987). Disparities have also been found in the quality of the doctor-patient relationship. For example, one-quarter of women (compared with 12 percent of men) reported that they have been "talked down to" or "treated like a child by a physician," and 17 percent of women (compared with 7 percent of men) had been told that a medical condition they experienced was "all in their head" (The Commonwealth Fund, 1993; Horton, 1995).

Race, ethnicity, national origin, and religion. Discrimination on the basis of race, ethnicity, national origin, or religion in the provision of health care has also been well documented. There is evidence of disparities in the quality of care, access to health care (because of language or geographic barriers), and the amount of care given to minorities as compared with others (Kahn et al., 1994; Giles et al., 1995; Rosenbaum et al., 1997; Smollar, 1988). In the case of facilities or individuals who accept Federal funds, Federal civil rights statutes prohibit the denial of services; the provision of a different service or services in a different manner from those provided to others; and the segregation of or separate treatment of individuals in any matter related to receiving services (Office of Civil Rights, 1990).

Age. Discrimination against consumers based on their age also occurs in the health care industry including: less aggressive treatment for elderly women with breast cancer and lower than average referral rates for mental health services in older people (Nattinger et al., 1992; Osteen et al., 1992; Ayanian et al., 1993). The Age Discrimination Act of 1972 also prohibits discrimination based on age by any institution or health care provider who accepts Federal funds.

Sexual orientation. Gay and lesbian patients have received reduced care or have been denied care because of their sexual orientation (AAPHR, 1994). Discrimination against gay/lesbian consumers has sometimes been compounded by fears of HIV.

Disability status. There is an extensive history of discrimination against people with disabilities and chronic illnesses that has led to action by Federal and State Government. The Americans with Disabilities Act of 1990 (ADA) prohibits discrimination against individuals with real or perceived disabilities in employment, public services, public accommodations, communications, and employer-provided health insurance. The Health Insurance Portability and Accountability Act of 1996 prohibits the exclusion of an individual from the group insurance market for more than 12 months based on a preexisting medical condition. The Mental Health Parity Act of 1996 prohibits differential lifetime or annual caps on coverage for physical and mental illnesses in certain situations.

Despite passage of these landmark laws, not all Americans living with disabilities or adverse medical conditions have access to health coverage at a cost they believe is fair or affordable. This is particularly true for consumers attempting to purchase coverage in the individual insurance market. Research into further refinements in the insurance market is needed to assist these individuals. The Commission strongly urges insurers, public and private purchasers, State and Federal Governments, and others to explore all policy options to make health coverage available and affordable to Americans who wish to obtain it, especially those who are living with mental or physical disabilities and chronic illnesses.

Finally, despite recent improvements, many health care facilities remain inaccessible to individuals with disabilities (Savage, 1997). The Commission believes that elimination of physical and communication barriers in health care facilities should be a higher priority for government agencies charged with enforcing the ADA.

Source of payment. The health care system currently is undergoing an historic transformation in which low-income Medicaid beneficiaries are being enrolled into private health plans. While this is a positive development in terms of access for traditionally vulnerable populations to high-quality care, it is almost certain to create additional tensions that could be manifest in discrimination. Providers who agree to accept Medicaid beneficiaries must provide equal access, care, and waiting times to those patients. It will be vitally important for State and Federal agencies to closely monitor the provision of care to Medicaid beneficiaries as they move into new health plans.

Consumers will need to be vigilant in reporting instances of discrimination based on the factors discussed in this chapter. Consumers also must extend the same level of respect to health care providers and others in the health care system that they demand of same. An environment of mutual respect is essential to a healthy relationship between consumers and those who care for them.

Health care professionals and other health workers have the most direct contact with patients and, therefore, have the greatest responsibility to treat health care consumers with respect and to ensure that they do not discriminate. Providers have a responsibility to listen to patients and take their concerns and complaints seriously. Providers also have a responsibility to monitor their treatment of patients to assure they are treated with respect and nondiscrimination and to correct problems when they occur.

Health care facilities that renovate existing facilities or construct new ones must meet a high standard of access in order to avoid discriminating against persons with disabilities. While there is no ADA requirement to "retrofit" existing facilities to make them accessible, there is a responsibility to remove "readily achievable" physical and communication barriers. All health care providers should assess the level of access in their medical facilities and take steps to provide effective communication and unimpeded physical access to the maximum extent possible.

Health plans will need to examine the standards and incentives that exist within their systems that may inadvertently discourage providers from attending to the interpersonal aspects of health care quality that can be manifest as disrespect. Consumers enrolled in health plans with defined networks of providers should have access to their plans' participating providers, without regard to the source of their coverage (e.g., Medicare, Medicaid, employer-sponsored plan).

Quality oversight organizations should utilize tools that allow accurate measurement of dimensions of health care quality that reflect consumer concerns about being treated with respect. Public disclosure of these findings, together with measurements of clinical quality of care, cost, benefit, and other salient information can allow consumers to determine the relative importance they place on such information and make their purchasing decisions accordingly.

Health care worker education and training programs need to recognize and act upon the need for improvements in communication skills by providers. Receiving inadequate explanations and advice, having inadequate time to receive answers to questions, and failure to attend to the need for emotional support can have adverse consequences on health outcomes (Bame et al., 1993; Patterson et al., 1991; Juncos, 1990). Similarly, education and training programs need to develop and implement course content addressing the significance of cultural attitudes on the effectiveness of health care and the importance of being sensitive to the varying needs of people with disabilities, including those with sensory or cognitive disabilities, who often require auxiliary aids or extra time and plain-language explanation to ensure effective communication. Health plans, hospitals, and other large institutional providers are encouraged to have on-site interpreters for any language population that exceeds a specified standard (e.g., 5 percent or more) and telephone interpreter services for other language minorities. Written material provided to patients should also be translated for the larger linguistic groups.

AMA Council on Ethical and Judicial Affairs. Genetic Disparities in Clinical Decision-Making: Council Report. January 1991; 15(4):25-35.

American Associations of Physicians for Human Rights. Anti-Gay Discrimination in Medicine: Results of a National Survey of Lesbian, Gay and Bisexual Physicians. San Francisco; 1994.

Ayanian JZ, Kohler BA, Abe T, et al. "The Relation Between Health Insurance Coverage and Clinical Outcomes among Women with Breast Cancer." N Eng J Med 1992; 326:1102-1107.

Bame S, Petersen N, et al. "Variation in Hemodialysis Patient Compliance According to Demographic Characteristics." Soc Sci Med, Oct. 1993; 37(8):1035-1043.

Beery TA. "Diagnosis and Treatment of Cardiac Disease: Gender Bias in the Diagnosis and Treatment of Coronary Artery Disease." Heart & Lung. November 1995; 24(4):427-435.

The Commonwealth Fund. The Commonwealth Fund Survey of Women's Health. New York: July 1993.

Davis K, Collins KS, et al. "Choice Matters: Enrollees' Views of Their Health Plans." Health Affairs, Summer 1995; 9-112.

Edgeman-Levitan S, Cleary PD. "What Information Do Consumers Want and Need? A Synthesis of Research to Date, Plus Interviews with Health Plan Managers and Consumer Advocates." Health Affairs, Winter 1996; 15(4):42-56.

Faden R, Beauchamp T. A History and Theory of Informed Consent. New York: Oxford University Press, 1986; 8-9.

Giles WH, Anda RF, Casper ML, et al. "Race and Sex Differences in Rates of Invasive Cardiac Procedures in US Hospitals." Arch Intern Med 1995; 155.

Horton JA, ed. The Women's Health Data Book: A Profile of Women's Health in the United States. Washington, DC: Elsevier; 1995.

Kahn KL, Pearson ML, et al. "Health Care for Black and Poor Hospitalized Medicare Patients." JAMA 1994; 27(1).

Juncos LI. "Patient Compliance and Angiotensin Converting Enzyme Inhibitors in Hypertension." J Cardiovascular Pharmacol 1990; 15(3):S22-S25.

Levinson W, Roter DL, et al. "Physician-Patient Communication: The Relationship with Malpractice Claims among Primary Care Physicians and Surgeons." JAMA 1997; 277(7):553-559.

Nattinger AB, Gottlieb MS, Veum J, et al. "Geographic Variation in the Use of Breast-Conserving Treatments for Breast Cancer." N Eng J Med 1992; 326:1102-1107.

Office of Civil Rights. Fact Sheet. U.S. Department of Health and Human Services; 1990.

Osteen RT, Steele GD Jr, Menck HR, et al. "Regional Differences in Surgical Management of Breast Cancer." CA Cancer J Clin 1992; 42:39-43.

Patterson R, Greenberger PA, et al. "Potentially Fatal Asthma; the Problem of Noncompliance." Ann Allergy, Aug 1991; 67(2):138-142.

Rosenbaum S, Serrano R, et al. "Civil Rights in a Changing Health Care System," Health Affairs Jan-Feb 1997.

Savage E. U.S. Department of Justice. verbal communication; September 1997.

Smollar D. "Success of Indochinese Students May Vary with Ethnic Factors." Los Angeles Times, Feb 16, 1988.

Tobin JN, et al. Ann Internal Med. 1987;107.

Consumer Bill of Rights and Responsibilities
Chapter Six
Confidentiality of Health Information

With very few exceptions, individually identifiable health care information can be used without written consent for health purposes only, including the provision of health care, payment for services, peer review, health promotion, disease management, and quality assurance.

In addition, disclosure of individually identifiable health care information without written consent should be permitted in very limited circumstances where there is a clear legal basis for doing so. Such reasons include: medical or health care research for which an institutional review board has determined anonymous records will not suffice, investigation of health care fraud, and public health reporting.

To the maximum feasible extent in all situations, nonidentifiable health care information should be used unless the individual has consented to the disclosure of individually identifiable information. When disclosure is required, no greater amount of information should be disclosed than is necessary to achieve the specific purpose of the disclosure.

The legal right to confidentiality of health care information and its essential role in the delivery of quality health care has been recognized by the United States Supreme Court, lower Federal and State courts, and Federal and State lawmakers. Similarly, a health care provider's obligation to protect the confidentiality of health information is universally recognized. The assurance that consumers' health information will remain confidential is "fundamental to effective diagnosis, treatment and healing" (Shalala, 1997).

At the same time, the quality of the health care system also depends on the regular exchange of information between providers, employers, plans, public health authorities, researchers, and other users. The changing structure of the health care system and rapid advances in information technology and medical and health care research have increased the demand for and supply of health information among traditional users such as the treating physician, and new users, such as large networks of providers, information management companies, quality and utilization review committees, and independently contracted service providers. Concerns have been raised that, under the current system of information exchange, various entities can access individually identifiable information without sufficient security safeguards and consent requirements.

Other activities undertaken to improve quality and efficiency may present new risks to the confidentiality of health information. For example, quality oversight activities by plans, providers, accreditation bodies, and regulatory agencies require detailed information about the treatment and benefit status of individual consumers. The growing role of employers in workforce health issues has also contributed to the confidentiality debate.
Congress has made repeated attempts to enact a comprehensive Federal confidentiality law but has, to date, been unsuccessful. The web of protections at the Federal and State level that has evolved in the absence of a comprehensive law leaves many aspects of health information unevenly protected. Specialized Federal protections already exist through statutes that address substance abuse, Medicaid beneficiaries, public health, research, government records, and those living with disabilities.

Several States have enacted comprehensive laws and an effort is currently under way at the National Association of Insurance Commissioners to draft a Protected Health Information Model Act for States. Other safeguards have evolved outside of the legislative arena. Accreditation bodies have incorporated requirements for confidentiality policies and patient consent (JCAHO 1996; NCQA 1997; URAC 1996) and continue to collaborate on security and confidentiality issues (JCAHO/NCQA Joint Session, 1997).

The Health Insurance Portability and Accountability Act of 1996 (HIPAA) required the Secretary of Health and Human Services to submit to the Congress detailed recommendations on: (1) the rights that an individual who is a subject of individually identifiable information should have; (2) the procedures that should be established for the exercise of such rights; and (3) the uses and disclosures of such information that should be authorized or required (Public Law 104-191). On September 11, Health and Human Services Secretary Donna Shalala presented those proposals to the Congress (Shalala, 1997). Under the terms of HIPAA, if Congress fails to enact Federal confidentiality legislation by August 1999, the Secretary of HHS is required to promulgate regulations setting confidentiality standards.

The Secretary recommends a comprehensive Federal confidentiality law that would apply "floor preemption," meaning that the law would require that all States comply with a minimum set of confidentiality requirements but would not preempt stronger State laws.

Section 262 of HIPAA also requires the Secretary of HHS to adopt standards by February 1998 for electronic transmission of financial and administrative health care transactions (including information about claims, eligibility, payment, and injury), unique health identifiers (for individuals, employers, plans, and providers), and security.

The Commission believes that it is essential to establish a comprehensive confidentiality framework and encourages the Congress to move forward expeditiously.

Health plans, health providers, employers, and other group purchasers should examine existing confidentiality protections to safeguard against improper use or release of individually identifiable information. The Commission does not intend to impede employers or providers from complying with duties established by law. Health providers, facilities, and plans should develop procedures to ensure that when sensitive services (e.g., mental health, substance abuse, reproductive services, or treatment of sexually transmitted diseases) are involved, standard administrative techniques do not inadvertently disclose information to individuals other than the patient. This is not intended to create two standards of nondisclosure -- one for sensitive medical conditions and another for all others. It is merely a recognition that there may be high level concern about confidentiality with certain medical conditions by some patients.

Law enforcement officers, researchers, and public health agencies should examine their existing policies to ensure that they access individually identifiable information only when absolutely necessary and provide proper safeguards to assure confidentiality.

Consumers should become more aware of the content of their health records and pay particular attention to requests by providers, plans, employers, or others to gain access to those records.

Hurwit C. Citizen Action. testimony before the President's Advisory Commission on Consumer Protection and Quality in the Health Care Industry. May 13, 1997.

Joint Commission on Accreditation of Healthcare Organizations, Comprehensive Accreditation Manual for Health Care Networks; 1996.

Joint Commission on Accreditation of Healthcare Organizations and National Committee for Quality Assurance. Joint Session on Security and Confidentiality of Patient Medical Information. Washington, DC; 1997.

Lowrance W. Privacy and Health Research: A Report to the U.S. Secretary of Health and Human Services; May 1997.

National Association of Insurance Commissioners. "Insurance Information and Privacy Protection Model Act" (October 1992); "Quality Assessment and Improvement Model Act" (July 1996); "Utilization Review Model Act" (October 1996).

National Committee for Quality Assurance (NCQA). "Draft Standards for Accreditation;" 1997.

Public Law No. 104-191, "The Health Insurance Portability and Accountability Act of 1996."

Pyles JC, on behalf of the National Coalition for Patient Rights. "The Right to Medical Privacy: An Indispensable Element of Quality Health Care." Washington, DC; 1997.

Shalala, Donna E. Secretary of Health and Human Services. "Confidentiality of Individually Identifiable Health Information: Recommendations Pursuant to Section 264 of the Health Insurance Portability and Accountability Act of 1996." Submitted to The Committee on Labor and Human Resources and the Committee on Finance of the Senate, and The Committee on Commerce and the Committee on Ways and Means of the House of Representatives. September 11, 1997.

URAC National Network Accreditation Standards (April 1996).

Timely written notification of a decision to deny, reduce, or terminate services or deny payment for services. Such notification should include an explanation of the reasons for the decisions and the procedures available for appealing them.

Resolution of all appeals in a timely manner with expedited consideration for decisions involving emergency or urgent care consistent with time frames consistent with those required by Medicare (i.e., 72 hours).

A claim review process conducted by health care professionals who are appropriately credentialed with respect to the treatment involved. Reviews should be conducted by individuals who were not involved in the initial decision.

Written notification of the final determination by the plan of an internal appeal that includes information on the reason for the determination and how a consumer can appeal that decision to an external entity.

Reasonable processes for resolving consumer complaints about such issues as waiting times, operating hours, the demeanor of health care personnel, and the adequacy of facilities.

External appeals systems should:

Be available only after consumers have exhausted all internal processes (except in cases of urgently needed care).

Apply to any decision by a health plan to deny, reduce, or terminate coverage or deny payment for services based on a determination that the treatment is either experimental or investigational in nature; apply when such a decision is based on a determination that such services are not medically necessary and the amount exceeds a significant threshold or the patient's life or health is jeopardized.

Be conducted by health care professionals who are appropriately credentialed with respect to the treatment involved and subject to conflict-of-interest prohibitions. Reviews should be conducted by individuals who were not involved in the initial decision.

Follow a standard of review that promotes evidence-based decisionmaking and relies on objective evidence.

Resolve all appeals in a timely manner with expedited consideration for decisions involving emergency or urgent care consistent with time frames consistent with those required by Medicare (i.e., 72 hours).

Health care consumers, like other purchasers, have concerns about the service they receive. Unlike other consumers, however, health care consumers have special interests at stake -- the length and quality of their lives. How consumer complaints are addressed has a significant impact on the quality of health services provided and on the satisfaction of consumers with the individuals and institutions that provide them.

Fair and efficient procedures for resolving consumer complaints about their health care serve many purposes. First and foremost, enhanced internal and external review processes will assist consumers in obtaining access to appropriate services in a timely fashion, thus maximizing the likelihood of positive health outcomes. Second, they can be used to bridge communication gaps between consumers and their health plans and providers, and to provide useful information to all parties regarding effective treatment and consumer needs. Third, the opportunity for consumers to be heard by people whose decisions significantly touch their lives evidences respect for the dignity of consumers as individuals and engenders their respect for the integrity of the institutions that serve them.

Properly structured complaint resolution processes should promote the resolution of consumer concerns as well as support and enhance the overall goal of improving the quality of health care. Internal and external complaint and appeal processes should be:

Timely.

Fair to all parties.

Administratively simple.

Objective and credible.

Accessible and understandable to consumers.

Cost and resource efficient.

Subject to quality review.

Internal and external complaint and appeal processes should not interfere with communication between consumers and their health care providers. For example, in instances where consumers and their providers agree that a service should be reduced or terminated, no written notification of such decisions is needed. Additionally, health care providers who participate in the complaint and appeal processes on behalf of patients should be free from discrimination or retaliation. Likewise, consumers who file a complaint against a provider or plan should be free from discrimination or retaliation.

For the purposes of this chapter, the following definitions are used for the terms "complaints" and "appeals":

  Complaint. A "complaint" is any expression of dissatisfaction to a health plan, provider, or facility by a consumer made orally or in writing. This includes concerns about the operations of providers, insurers, or health plans, such as waiting times, the demeanor of health care personnel, the adequacy of facilities or the respect paid to consumers, and claims regarding the right of the consumer to receive services or receive payment for services previously rendered, including the organization's refusal to provide services the consumer believes he or she is entitled to.

Appeal. An "appeal" is a consumer's request for a health plan, facility, or provider or other body to change an initial decision. An appeal process is a procedure for reconsideration of a specific determination made by a health provider, facility or plan.

Currently, many different procedures are used by group purchasers, health plans, and provider organizations to respond to consumer complaints. Licensed health plans are subject to numerous State and Federal laws, and many also comply with the standards of private accrediting bodies (e.g., NCQA, 1997; JCAHO, 1996; AAHCC/URAC, 1996). Virtually all private and public health plans provide consumers with some form of complaint resolution process. The Commission does not intend by these recommendations to weaken existing consumer protections. These include:

  State Licensed Insurance Products. States traditionally have regulated the benefit structure, solvency, rates, and claims process of indemnity insurance companies doing business in the State. Some State insurance regulations require health insurers doing business in the State to provide certain complaint procedures to enrollees (Abraham, 1990). In addition, all 50 States have laws licensing or governing HMOs doing business in the State separate from their laws regulating indemnity insurance products. Many States' laws are based on the model HMO law drafted by the National Association of Insurance Commissioners (NAIC, 1996), which requires HMOs to establish complaint procedures approved by the State's insurance commissioner. An estimated 30 States have some specified complaint procedures that HMOs must follow and at least 7 States now require an expedited appeal for denials of urgently needed care.

ERISA Plans. All employers offering health benefits to their employees through managed care organizations or traditional indemnity insurers must comply with requirements of the Employee Retirement Income Security Act. ERISA requires private employer-provided health benefit plans to disclose certain information to plan participants, to report information to the Federal government, and to pay benefits that are promised under the plan. ERISA regulations generally require employer health plans to approve or deny claims within 90 days and to approve or deny appeals of claims denials within 60 days. Although ERISA health plans are required to establish and disclose complaint and appeals procedures to participants, and to notify participants of claims denials, the plans are not required to provide a particular complaint procedure (Butler and Polzer, 1996). An internal reconsideration of denied claims is stipulated but appeals may be decided by the same plan administrators that initially denied the claim. Determinations must be in writing and state specific reasons for the decision.

Medicare. Under the Medicare fee-for-service system, fiscal intermediaries and carriers must provide a two-step internal review and notification of their final decision before a beneficiary is entitled to seek reconsideration from the Social Security Administration's payment division and the Health Care Financing Administration (Kinney, 1996). Medicare provides a graded appeal process that includes a hearing before an administrative law judge and administrative appeals council review for claims under Part A (hospital coverage) if the amount in controversy is more than $100; and under Part B (physical and outpatient coverage) if the claims are more than $500. Claims under Part A and Part B for more than $1,000 are entitled to judicial review.

HMOs that participate in Medicare are required to provide meaningful internal procedures for resolving complaints about the quality of care, untimely provision of care, or the improper demeanor of health care personnel (Stayn, 1994). HMO decisions to deny coverage for certain treatment, referral outside a plan, or reimbursement for emergency or out-of-area care are subject to an external review and administrative appeal. HCFA has contracted with a private organization, the Center for Health Dispute Resolution, to perform these reconsiderations (Richardson, Phillips, and Conley, 1993). After external review, a Medicare beneficiary enrolled in an HMO who is "dissatisfied by reason of his failure to receive any health service to which he believes he is entitled and at no greater charge than he believes he is required to pay" has a right to Social Security administrative review for controversies more than $100 and judicial review for controversies more than $1,000.

Medicaid. The Federal Medicaid statute requires State agencies to provide beneficiaries with a fair hearing and an administrative appeal when their eligibility or requests for services are denied or not acted upon within reasonable time. These State agency determinations can be challenged in State court under State administrative procedure acts or in Federal court. In addition, HMOs that contract to serve Medicaid beneficiaries must establish an internal complaint procedure that will resolve disputes promptly. These internal procedures are subject to review and approval by the State. Medicaid HMO enrollees have the same rights to administrative appeal as do fee-for-service enrollees and no recommendations are made concerning the changing of such rights.

Federal Employees Health Benefit Program. Federal employees and their dependents receive coverage through private insurance carriers, including more than 300 HMOs. Under the FEHBP complaint resolution process, enrollees may bring disputes concerning benefits or services to the Office of Personnel Management for review after asking the plan to reconsider its initial denial and failing to receive a satisfactory reply. OPM seeks to determine whether the enrollee or family member is entitled to the services or supply under the terms of the contract.

Other Approaches. The federal HMO Act requires that to be a "federally qualified HMO," a plan must provide meaningful procedures for hearing and resolving complaints between subscribers and the plan. The written procedures must be easily understood and provided upon request. HMOs are not required to comply with the Act's requirements but may do so to obtain favored status. Other approaches to complaint resolution exist in the Department of Defense's health programs, including the Civilian Health and Medical Program of the Uniformed Services (CHAMPUS).

Assuring that all consumers have access to both internal and external processes that satisfy the requirements of this right will require action on virtually every level of the health care industry.

  Enhancing Internal Review Systems. Health plans will need to examine their existing internal review systems to assure that consumers receive a timely, understandable notice of decisions to deny, reduce, or terminate treatment or pay claims; notice of the reasons for that determination and of the complaint and appeals procedures available to them; and expedited processes for certain types of cases. While there do not appear to be reliable data indicating how many health plans currently provide internal complaint procedures, most apparently do. Thus, implementation of a general right to file internal complaints, to appeal within a health plan, and to receive a response will not require a majority of health plans to change their current practices significantly. It will be important for quality oversight organizations (State licensure programs, Federal certification programs, and private accrediting bodies) to assure that their standards and review processes adequately address internal complaint and appeal processes of health plans.

Establishing Independent External Appeals Systems. Additional analysis must be done to identify the most effective and efficient methods of establishing the independent external appeals function. Issues to be considered include: mechanisms for financing the external review system; sponsorship of the external review function; design of review processes to assure evidence-based decisionmaking; qualifications of reviewers; consumer cost-sharing responsibilities (e.g., filing fees); and methods of overseeing and holding external appeals entities accountable. It will also be important to establish an ongoing evaluation mechanism to assess the impact of the external appeals process on access to appropriate services, rates of consumer disputes, litigation rates, consumer satisfaction, and costs. The evaluation mechanism should also assess the impact of certain design characteristics on the effectiveness and efficiency of the external appeals process.

Abraham KS. Insurance Law and Regulation 92-139; 1990.

American Accreditation Health Care Commission/Utilization Review Accreditation Commission (AAHCC/URAC). National Network Accreditation Standards. Washington, DC; April 1996.

American Association of Health Plans. Health Plans Announce Policies on Appeals Rights and Emergency Care Coverage. Washington, DC; January 1997.

American Bar Association, Commission on Legal Problems of the Elderly, Roundtable on the Resolution of Consumer Disputes in Managed Care. Washington, DC; 1997.

American Hospital Association: State Issues Forum. Designing Consumer Protection Standards. Chicago; 1996.

American Psychiatric Association. Principles for the Provision of Mental Health and Substance Abuse Treatment Service: A Bill of Rights. Washington, DC; 1997.

Atkins G, Bass L and K. ERISA Preemption: The Key to Market Innovation in Health Care. New York: Corporate Health Care Coalition; 1995.

Butler P, Polzer K. Private Sector Health Coverage: Variation in Consumer Protections under ERISA and State Law. Washington, DC: National Health Policy Forum, George Washington University; June 1996.

Citizen Action. Campaign for Health Security Managed Care Principles. Washington, DC; January 1997.

Committee on Choice and Managed Care. Assuring Public Accountability and Information, Improving the Medicare Market: Adding Choice and Protections. Washington, DC: Institute of Medicine; 1996.

Dame L, Wolfe SM. Serious Problems for Older Americans in Health Maintenance Organizations. Public Citizen's Health Research Group; May 1995.

Families USA. HMO Consumers at Risk: States to the Rescue. Washington, DC; 1996. Update March 1997.

Joint Commission on Accreditation of Healthcare Organizations, 1996. Accreditation Manual for Hospitals. Chicago; 1996.

Kinney ED. "Resolving Grievances in a Managed Care Environment." Health Matrix 1996 winter; 6:147-165.

Kinney ED. "Protecting Consumers and Providers under Health Reform: An Overview of the Major Administrative Law Issues." Health Matrix 1995; 5:83-138.

Medicare Rights Center. Medicare Appeals and Grievances: Strategies for System Simplification and Informal Consumer Decisionmaking. New York; 1996.

National Association of Insurance Commissioners (NAIC). Health Carriers Grievance Procedure Model Act. October 1996.

National Committee on Quality Assurance (NCQA). "Standards for Members' Rights and Responsibilities." Surveyor Guidelines; April 1, 1997.

Physician Payment Review Commission. Annual Report to Congress 1997. Washington, DC; 1997.

Public Policy and Information Fund of New York. The Managed Care Consumers' Bill of Rights. New York; October 1995.

Richardson DA, Phillips J, Conley D Jr. A Study of Coverage Denial Disputes between Medicare Beneficiaries and HMOs. Pittsford (NY): Center for Health Dispute Resolution, Network Design Group, Inc.; September 1993.

Rodwin MA. "Managed Care and Consumer Protection: What are the Issues?" Seton Hall Law Review Winter 1996; 26:1007-1054.

Stayn SJ. "Securing Access to Care in Health Maintenance Organizations: Toward a Uniform Model of Grievance and Appeals Procedures." Columbia Law Review June 1994; 94:1674-1720.

Statement of Responsibilities In a health care system that protects consumers' rights, it is reasonable to expect and encourage consumers to assume reasonable responsibilities. Greater individual involvement by consumers in their care increases the likelihood of achieving the best outcomes and helps support a quality improvement, cost-conscious environment. Such responsibilities include:

Take responsibility for maximizing healthy habits, such as exercising, not smoking, and eating a healthy diet.

Become involved in specific health care decisions.

Work collaboratively with health care providers in developing and carrying out agreed-upon treatment plans.

Disclose relevant information and clearly communicate wants and needs.

Use the health plan's internal complaint and appeal processes to address concerns that may arise.

Avoid knowingly spreading disease.

Recognize the reality of risks and limits of the science of medical care and the human fallibility of the health care professional.

Be aware of a health care provider's obligation to be reasonably efficient and equitable in providing care to other patients and the community.

Become knowledgeable about his or her health plan coverage and health plan options (when available) including all covered benefits, limitations, and exclusions, rules regarding use of network providers, coverage and referral rules, appropriate processes to secure additional information, and the process to appeal coverage decisions.

Show respect for other patients and health workers.

Make a good-faith effort to meet financial obligations.

Abide by administrative and operational procedures of health plans, health care providers, and Government health benefit programs.

Report wrongdoing and fraud to appropriate resources or legal authorities.

In providing consumers with a set of rights and protections, the Commission believes that individual consumers must assume certain responsibilities. Responsibilities create benefits not only for individual consumers and their families but also for the health care system and society as a whole. Improved health status reduces medical costs for the patient, the payer, and society.

The Commission, however, does not intend to create a link between an individual's conduct in meeting his or her responsibilities and the obligations of plans and providers to provide covered services.

Increased patient responsibility can improve consumers' sense of self-worth. For example, increased responsibility among individuals living with disabilities has resulted in increased independence for that population (Rodwin, 1994; National Health Council, 1995). In fact, this is the principle behind the independent living movement, where people with disabilities live in their homes with personal assistant services rather than in institutions. Individuals report that increased responsibility for their health has led to improved self-esteem and a greater sense of empowerment.

Promoting consumer responsibility is an essential component of the effort toward involving consumers directly in decisionmaking about their health and medical care. Consumers often perceive that the medical professionals who care for them are acting in a condescending or paternalistic manner. They resent being put in a position of dependence and being treated as if they are infantile and object to the presumption that they are incapable of making choices themselves (Rodwin, 1994).

While the Commission believes that consumers must assume certain responsibilities, it also recognizes that reasonable accommodations must be made for numerous consumers with disabilities. For example, some individuals with physical and mental disabilities require assistance with self care; for some individuals with mental disabilities, noncompliance with treatment regimes is a manifestation of their disability; and some individuals with mental and physical disabilities are unable -- due to their disability -- to clearly communicate their wants and needs and, therefore, rely on the assistance of a designated representative. In each case, the health care system must recognize these issues and accommodate these needs. The Commission also recognizes that there are many other factors, such as occupational hazards, language, and income status, that may pose significant barriers to consumers meeting these responsibilities.

Consumers who are able should take the opportunity to educate themselves with respect to the specifics of their benefit coverage and to learn how to access the health care and services available to them as a result of that coverage. This includes:

Reading and understanding written information that explains benefit coverage.

Reading and understanding information that describes health plan processes and procedures to follow when seeking care by a physician, hospital, or other provider.

Seeking information or clarification of information from the health plan as necessary.

Using the health plan's processes for addressing complaints or grievances when disputes with providers or health plan procedures arise.

Consumer responsibility is particularly relevant to the broad right to information established in this Consumer Bill of Rights and Responsibilities (see Chapter One). The Right to Information requires the disclosure of information to consumers either directly or upon request on such things as benefits, cost-sharing, complaints and appeals processes, licensure, accreditation, and performance measures. The Right to Information will improve health outcomes only to the extent that consumers have a choice of health plans and use that information in exercising the choice.

Although there is significant value in promoting the consumers' participation in their own health care by increasing their level of responsibility, it is important to set limits on the amount of responsibility expected. The patient's responsibility to comply with medical advice is limited by the principle of informed consent (Benjamin, 1985). The patient retains the right to choose whether to follow medical advice or not, as long as he or she is willing to accept the health outcome consequences that may result from noncompliance, and the noncompliance does not adversely affect the public (Brock and Wartman, 1994).

Consumers do not have a duty to be subjected to a treatment regime they have good reason to avoid -- for instance, one whose negative side effects outweigh its benefits (Mayer, 1992), or when excessive medication in an institutional setting is used to "control" residents. Most consumer responsibilities do not extend to those who are incompetent to make decisions, including infants, those who are judged to be mentally incompetent, and comatose patients (Emson, 1995; Mayer, 1992; National Health Council, 1995).

In addition, certain high-risk behaviors (smoking, use of smokeless tobacco, illegal drug use) are addictive and cannot be considered fully under the volitional control of the individual consumer. Caution must be used to avoid "blaming the victim." For example, Bayer (1996) notes that during the history of the AIDS epidemic, "the emphasis on personal responsibility was often associated with condemnation of those whose sexual or drug-using behavior had exposed them to HIV, as well as with calls for invasion of privacy and deprivations of liberty."

Compliance with agreed-upon treatment protocols is a particularly important consumer responsibility. Noncompliance with the taking of medication has particular implications for the health status of consumers. Noncompliance includes taking too much medication, taking medication not prescribed, not taking medication prescribed, altering the prescribed dosage, or altering the time between doses.

Finally, it is important to recognize that while consumers should seek to assume the responsibilities discussed in this report, many factors influence consumers' acceptance of medical advice. Some are related to the health care system itself and others are related to the patient's individual psychology. Imanaka, Araki, et al. (1993) identified patient dissatisfaction with their health care providers and plans as a primary cause of patient noncompliance. Several studies have identified inadequate provider-consumer communication as a contributing factor (Imanaka, 1993; Ross, 1991; Donovan and Blake, 1992; Sluijs, Kok, et al., 1993). This leads to situations where:

The patient and the prescriber have a different understanding of what the patient is supposed to do.

The patient lacks information or understanding about the disease, pathology, or symptoms.

The patient does not understand the correct purpose of the intervention.

The patient and the health care provider have insufficient time to discuss the full range of issues concerning compliance.

Noncompliant patients also may have underlying psychiatric disorders. Yellowless and Ruffin (1989) found that 40 percent of patients who experience a life-threatening asthma episode have psychiatric disorders. Patients often are trying to balance the requirements of their prescribed medical regimen with other aspects of their life (Donovan and Blake, 1992). Finally, some patients choose not to comply with medical instructions as a way of expressing their attempts to cope with their disease; as a reaction to the way they have been treated by doctors; or as a way of fighting the system by breaking its "symbolic" rules (Ross, 1991).

Consumers will have to play an active role in the treatment and management of their health. Consumers will need to ask more questions of their health care providers, insurers, and institutions. They will need to express their wishes and desires clearly to those who care for them and to their family members in the event of incapacity; this should be done before an incapacity occurs. They will need to make sure that they understand a treatment regimen that is prescribed for them before they agree to follow it. Once they have made such an agreement, consumers will need to make every effort to comply and, if they cannot, to notify their provider of their desire or need to change that regimen. Consumers will need to recognize the financial and societal impact of their health care decisions and their health care choices should reflect this consideration.

Health care providers will need to communicate more clearly with their patients and their patients' families about diagnoses, treatment options, and treatment protocols. They will need to make greater efforts to ensure that those matters are clearly understood and agreed to. They will need to work with their patients to ensure that treatment regimens are possible to follow and that changes in treatment are made when possible to meet patients' needs or demands.

Health plans will need to consider ways to encourage greater communication between consumers and health care professionals, including incentives for such communication and acceptance of treatment regimens.

Adams ML. "The Public Health Impact and Economic Cost of Smoking in Connecticut -- 1989." Conn Med April 1994; 58(4):195-8.

American Hospital Association. Designing Consumer Protection Standards: State Issues Forum. Washington, DC; October 1996.

American Medical Association. Code of Medical Ethics 1996-1997. Chicago, Illinois; 1997.

Arras JD. "Noncompliance in AIDS Research." Hastings Center Report September/October 1990; 24-32.

Bame S, Petersen N, et al. "Variation in Hemodialysis Patient Compliance According to Demographic Characteristics". Soc Sci Med October 1993; 37(8):1035-43.

Bayer R. "AIDS Prevention: Sexual Ethics and Responsibility." New Eng J of Med June 6, 1996; 334(23):1540-42.

Beers MK, Sliwkowski, et al. "Compliance with Medication Orders among the Elderly after Hospital Discharge." Hosp Formul July 1992; 27:720-724.

Benjamin J. "Lay Obligations in Professional Relations." J Med Philos 1985; 10(1):85-103.

Brock, DW, Wartman SA. "When Competent Patients Make Irrational Choices." In: Beauchamp T, Walters L, editors. Contemporary Issues in Bioethics. 4th ed. Belmont, CA: Wadsworth Publishing; 1994.

Brody H. "Patients' Responsibilities." In: Reich W, editor. Encyclopedia of Bioethics. Revised ed. New York, NY: Simon and Schuster Macmillian; 1995.

Cebrun AJ. "Consumer Responsibility in the HMO Environment." J Health Care Poor Underserved 1994; 5(3):179-181.

Col N, Fanale JE, Kronhom P. "The Role of Medication Noncompliance and Adverse Drug Reactions in Hospitalizations of the Elderly." Arch Intern Med 1990; (150):841-845.

Donovan JL, Blake DR. "Patient Non-compliance: Deviance or reasoned decision-making?" Soc Sci Med 1992; (34)5:507-513.

Eddy DE. "The Individual vs Society: Resolving the Conflict." JAMA May 8, 1991; (265)18:2399-2406.

Emson HE. "Rights, Duties, and Limits of Autonomy." Cambridge Q Healthc Ethics 1995; (4):7-11.

Harris J, Holm S. "Is There a Moral Obligation Not to Infect Others?" BMJ November 1995; 311(4):1215-1217.
Imanaka Y, Araki S, et al. "Effects of Patient Health Beliefs and Satisfaction on Compliance with Medication Regimens in Ambulatory Care at General Hospitals." Nippon Eiseigaku Zasshi June 1993; 48(2):601-11.

JCAHO. 1996 Comprehensive Accreditation Manual for Health Care Networks.

Jensen GJ, Lorish CD. "Promoting Patient Cooperation with Exercise Programs: Linking Research, Theory, and Practice." Arth Care and Res Dec 1994; 7(4):181-189.

Juncos LI. "Patient Compliance and Angiotensin Converting Enzyme Inhibitors in Hypertension." J Cardiovascular Pharmacol 1990; (15)Suppl 3:S22-5.

Macdonald M, Meyer KC, Essig B. Health Law Guidebook Series. New York: Matthew Bender, 1996.

Mayer M. "Patients' Duties." J of Med and Phil 1992; (17):541-555.

National Highway Traffic Safety Administration. Web page, 1997.

National Health Council. Principles of Patient Rights & Responsibilities. Washington, DC: January 1995.

NCQA. "Standards for Member's Rights and Responsibilities." 1997 Surveyor Guidelines.

Public Citizen Health Research Group Health Letter. June 1995; 11(6).

Rodwin M. "Patient Accountability and Quality of Care: Lessons from Medical Consumerism and the Patients' Rights, Women's Health and Disability Rights Movements." Am J Law Med 1994; (20)147.

Ross FM. "Patient Compliance: Whose Responsibility?" Soc Sci Med 1991; 32(1):89-94.

Sharkness CM, Snow DA. "The Patient's View of Hypertension and Compliance." Am J Prev Med 1992; 8(3):141-146.

Shiffman S. "Refining Models of Dependence: Variations across Persons and Situations." Br J Addict May 1991; 86(5):611-15.

Sluijs EM, Kok GJ, et al. "Correlates of Exercise Compliance in Physical Therapy." Phys Ther 1993; 73(11).

Sullivan SD, Kreling DH, Hazlet TK. "Noncompliance with Medication Regimens and Subsequent Hospitalizations; A Literature Analysis and Cost of Hospitalization Estimation." J Res Pharmac Econom 1990; 2:19-33.

TenHave, Loughlin. "Responsibilities and Rationalities: Should the Patient be Blamed?" Health Care Anal 1994; 2(12):112-117.

Tuohey JF. "Moving from Autonomy to Responsibility in HIV-Related Healthcare." Camb Q Healthc Ethics 1995; 4(4):64-70.

Weiss KB, Wagner DK. "Changing Patterns of Asthma Mortality: Identifying Target Populations at High Risk." JAMA 1990; 95(264):1683-7.

Yellowless PM, Ruffan RE. "Psychological Defenses and Coping Styles in Patients Following a Life-Threatening Attack of Asthma." Chest 1989; 95:1298-1303.

1. The term "health plans" is used throughout this report and refers broadly to indemnity insurers, managed care organizations (including health maintenance organizations and preferred provider organizations), self-funded employer-sponsored plans, Taft-Hartley trusts, church plans, association plans, State and local government employee programs, and public insurance programs (i.e. Medicare and Medicaid).

    

2. The right to external appeals does not apply to denials, reductions, or terminations of coverage or denials of payment for services that are specifically excluded from the consumer's coverage as established by contract.

    

3. The Commission examined proposals by organizations including: the American Association of Health Plans, the American Association of Retired Persons, the American Hospital Association, the American Medical Association, the Campaign for Health Security, Citizen Action, Families USA, the Health Insurance Association of America, HIP Health Plans, the Health Policy Tracking Service, Kaiser Permanente, Kaiser/Group Health, the Midwest Bioethics Center, the National Association of Insurance Commissioners, the National Committee on Quality Assurance, the National Health Council, the Public Policy and Education Fund of New York, the Service Employees International Union, the Utilization Review Accreditation Committee, and many others.

4. The term "health plan" is used throughout this report and refers broadly to indemnity insurers, managed care organizations (including health maintenance organizations and preferred provider organizations), self-funded employer-sponsored plans, Taft-Hartley trusts, church plans, association plans, State and local government employee programs, and public insurance programs (i.e., Medicare and Medicaid).

5. In the context of this chapter, health care information is defined as "any information, whether oral or recorded, in any form or medium, that is created or received by a health care provider, health plan, public health authority, employer, life insurer, school, university, health care clearinghouse; and relates to the past, present, or future physical or mental health or condition of an individual, the provision of health care to an individual, or the past, present, or future payment for the provision of health care to an individual."

6. The right to external appeals does not apply to denials, reductions, or terminations of coverage or denials of payment for services that are specifically excluded from the consumer's coverage as established by contract.