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TABLE OF CONTENTS
Cover
Transmittal Letters
Acknowledgements
Commission Members
Chairman's Vision
Executive Summary

1. Introduction
2. Overview
3. Coordination of Research
4. Education & Training of Health Care Practitioners
5. Information Development & Dissemination
6. Access & Delivery
7. Coverage & Reimbursement
8. Wellness and Health Promotion
9. Coordinating Federal CAM Efforts
10.    Recommendations & Actions

•  Acronyms
APPENDICES
A.    •  Executive Order
•  Commission Charter
B.    •  10 Rules for Health Care Reform
•  Pew Task Force Recommendations
C.    Commission Meetings
D.    General & Town Hall Meeting Participants
E.    Organizations Providing Information on Education and Training
F.    Workgroup Members
G.    Statement from Commissioners




    Executive Summary

    The White House Commission on Complementary and Alternative Medicine Policy (WHCCAMP) was established by Executive Order No. 13147 in March 2000. The order states that the Commission is to provide the President, through the Secretary of Health and Human Services, with a report containing legislative and administrative recommendations that will ensure public policy maximizes the potential benefits of complementary and alternative medicine (CAM) to all citizens. The report of the Commission is to address:

    • The coordination of research to increase knowledge about CAM products,
    • The education and training of health care practitioners in CAM,
    • The provision of reliable and useful information about CAM practices and products to health care professionals, and
    • Guidance regarding appropriate access to and delivery of CAM.

    The Commission's 20 Presidentially-appointed members represented an array of health care interests, professional backgrounds, and knowledge. Health care expertise was provided by both conventional and CAM practitioners.

    To accomplish its mission, the Commission held four Town Hall meetings (San Francisco, Seattle, New York City, and Minneapolis) to listen to testimony from hundreds of individuals, professional organizations, societies, and health care organizations interested in Federal policies regarding CAM. In addition to the town hall meetings, the Commission invited expert testimony during its 10 regular meetings held in the Washington, D.C. area The Commission asked clinicians, researchers, medical educators, representatives of health insurers and managed care organizations, benefits experts, regulatory officials, and policymakers to provide informational recommendations and documentation to support them. The Commission also solicited testimony from the public at each of its regular meetings. Finally, the Commission conducted a number of site visits to see first-hand how various medical institutions are integrating CAM into clinical practice and collaboration between CAM and mainstream health care providers.

    To develop recommendations, the Commissioners divided into work groups, each addressing a particular topic. The work groups' recommendations were then presented to the whole Commission, discussed, and used as a basis for developing final recommendations.

    Based on its mission and responsibilities, the Commission endorsed the following 10 guiding principles to shape the process of making recommendations and to focus the recommendations themselves:

    1. A wholeness orientation in health care delivery. Health involves all aspects of life-mind, body, spirit, and environment-and high-quality health care must support care of the whole person.

    2. Evidence of safety and efficacy. The Commission is committed to promoting the use of science and appropriate scientific methods to help identify safe and effective CAM services and products and to generate evidence that will protect and promote the public health.

    3. The healing capacity of the person. People have a remarkable capacity for recovery and self-healing, and a major focus of health care is to support and promote this capacity.

    4. Respect for individuality. Each person is unique and has the right to health care that is appropriately responsive to him or her, respecting preferences and preserving dignity.

    5. The right to choose treatment. Each person has the right to choose freely among safe and effective care or approaches, as well as among qualified practitioners who are accountable for their claims and actions and responsive to the person's needs.

    6. An emphasis on health promotion and self-care. Good health care emphasizes self-care and early intervention for maintaining and promoting health.

    7. Partnerships as essential to integrated health care. Good health care requires teamwork among patients, health care practitioners (conventional and CAM), and researchers committed to creating optimal healing environments and to respecting the diversity of all health care traditions.

    8. Education as a fundamental health care service. Education about prevention, healthy lifestyles, and the power of self-healing should be made an integral part of the curricula of all health care professionals and should be made available to the public of all ages.

    9. Dissemination of comprehensive and timely information. The quality of health care can be enhanced by promoting efforts that thoroughly and thoughtfully examine the evidence on which CAM systems, practices, and products are based and make this evidence widely, rapidly, and easily available.

    10. Integral public involvement. The input of informed consumers and other members of the public must be incorporated in setting priorities for health care and health care research and in reaching policy decisions, including those related to CAM, within the public and private sectors.


    CAM is a heterogeneous group of medical, health care, and healing systems other than those intrinsic to mainstream health care in the United States. While "complementary and alternative medicine" is the term used in this report, the Commission recognizes that the term does not fully capture all of the diversity with which these systems, practices, and products are being used by consumers, CAM practitioners, and mainstream health care institutions.

    The Commission recognizes that most CAM modalities have not yet been scientifically studied and found to be safe and effective. The fact that many Americans are using CAM modalities should not be confused with the fact that most of these modalities remain unproven by high-quality clinical studies. The Commission believes that conventional and CAM systems of health and healing should be held to the same rigorous standards of good science.

    Therefore, substantially more funding for research is needed to determine the possible benefits and limitations of a variety of CAM modalities, especially those that are already in widespread use. Well-designed scientific research and demonstration projects can help to determine which CAM modalities and approaches are clinically effective and cost-effective. With information from these studies, the public can make informed, intelligent decisions about their own health and well-being and the appropriate use of CAM interventions. Conventional and CAM practitioners also will benefit from the dissemination of this information.

    Although most CAM modalities have not yet been proven safe and effective, it is likely that some of them eventually will be, whereas others will not. The recommendations and actions in this report constitute a road map to help guide research and policy decisions over the next several years as more scientific and other information becomes available. In this context, many of the recommendations and actions may be useful immediately. Others may be more useful once a greater body of scientific evidence has been developed and made available.

    The Commission also notes the lack of an appropriate definition of complementary and alternative medicine and the need to differentiate between interventions that have been, or have the potential to be, found safe and effective and those that lack any scientific evidence of safety or effectiveness. Including the entire mix of CAM interventions under one umbrella fails to identify the merits and shortcomings of specific interventions. It is essential to begin separating the safe from the unsafe and the effective from the ineffective. Likewise, the heterogeneous array of education, training, and qualifications of CAM practitioners has made it difficult for the Commission to clearly and succinctly target its recommendations. This limitation must be addressed during the process of implementing the recommendations and actions.


    Coordination of Research
    The public's increased use of CAM has added urgency to the need to examine the safety and effectiveness of CAM practices and products and to discover the basic mechanisms underlying them. Basic, clinical, and health services research in CAM are essential for including CAM in the mainstream health care system.

    In addition, the growing influence of consumers on the health care system has created a need for more population-based research on CAM use and for public participation in shaping the direction of CAM research. Federal requirements and opportunities for such participation currently exist. Public members of Federal advisory committees, as well as the agencies they advise, would gain from orientation and training programs on how to provide input most effectively.


    Support for Research
    The NCCAM at the NIH is an example of how quality research in CAM can be executed by a Federal agency. Similar efforts should now be extended to other Federal agencies. These agencies with research and health care responsibilities need to assess the scope of scientific, clinical practice, health services, and public needs regarding CAM that are related to their missions and develop funding strategies to address them. Federal support is particularly needed for research on CAM products that are unpatentable and those that are frequently used by the public but unlikely to attract private research dollars. Congress and the Administration should consider simultaneous legislative and administrative incentives to stimulate private sector investment in such products. Also, CAM approaches that appear to be effective but may not attract private investment, should be considered for Federal support.

    Federal, private, and nonprofit sector support is essential to developing a body of evidence-based knowledge about CAM. Among the areas in need of study are the complex compounds and mixtures found in CAM products, multiple-treatment interventions, the effect of patient-practitioner interactions on outcomes, the individualization of treatments, modalities designed to improve self-care and promote wellness behaviors, and core questions posed by CAM that might expand our understanding of health and disease.

    The Commission commends the National Center for Complementary and Alternative Medicine (NCCAM) for its leadership and contributions to CAM research, methodology, research training, and infrastructure development and supports increases in these crucial activities, including database development and information dissemination. In addition, NCCAM should collaborate with 1) the Institute of Medicine, to develop guidelines for establishing research priorities in CAM and to address the ambiguity regarding definitions of CAM, thus making it easier to decide how to allocate resources; 2) the National Science Foundation, to examine frontier areas of science associated with CAM that lie outside the current research paradigm and to develop methodological approaches to study them; and 3) the World Health Organization, to study traditional systems of medical practice from a variety of cultures.

    The Commission also recognizes the work of the Office of Dietary Supplements, the National Cancer Institute's Office of Cancer Complementary and Alternative Medicine, the National Library of Medicine, and the other components of the National Institutes of Health (NIH) that are supporting research and related activities in CAM and recommends that they continue their efforts.


    Scope of Research
    A dialogue between CAM and conventional medicine appears to be emerging and efforts should be made to strengthen it. CAM and conventional medical practitioners and researchers; accredited research institutions; Federal and state research, health care, and

    regulatory agencies; private and nonprofit organizations; and the general public need to be included in the dialogue. Communication and cooperation are essential to improving the quality of CAM research and to the success of research applications.

    The same high standards of quality, rigor, and ethics must be met in both CAM and conventional research, research training, publication of results in scientific, medical, and public health journals, presentations at research conferences, and review of products and devices. Properly qualified CAM and conventional medical professionals should be represented on research, journal, regulatory, and health insurance review and advisory committees.

    Investigators engaged in research on CAM must ensure that people participating in clinical studies receive the protections to which they are entitled and which are required for all human subjects in clinical research. Moreover, licensed, certified, or otherwise authorized practitioners who are engaged in research on CAM should not be sanctioned solely because they are engaged in such research, as long as 1) their studies are well designed and approved by an appropriately constituted institutional review board (IRB), 2) they are following the requirements for the protection of human subjects, and 3) they are meeting their professional and ethical responsibilities. All CAM and conventional practitioners, whether they are engaged in research or not, must meet whatever state practice requirements or standards govern their authorization to practice. IRBs that review CAM research studies need the expertise of qualified CAM professionals, and accredited CAM institutions and professional organizations should establish IRBs whenever possible.

    Publication of research results in recognized peer-reviewed research journals is needed to provide reliable information about CAM to researchers, clinical practitioners, health services professionals, third party payors and the public. In addition, the decisions of third-party payers regarding access to and reimbursement for CAM therapies should be based on published evidence. Public and private resources can be used to conduct and update systematic reviews of the research literature on CAM. The Agency for Health Care Research and Quality (AHRQ) should expand its systematic reviews of CAM systems and treatments for use by private and public entities, and NCCAM and AHRQ should issue and regularly update a comprehensive, understandable summary of current clinical evidence in CAM for health care practitioners and the public.


    Research Training and Infrastructure
    Sustained, adequate funding is essential to building and maintaining a strong infrastructure for training skilled CAM researchers and conducting rigorous research. Federal agencies that have training programs as part of their health care missions should support training that addresses CAM-related questions relevant to their missions. Academic health centers at conventional institutions are gradually developing venues for exchanging experiences with CAM professionals regarding the training of conventional researchers in CAM practices, the introduction of CAM practitioners to the conventional research culture, and inclusion of CAM in research, research training, clinical, and medical education activities. Accredited CAM institutions are gradually expanding their capacity to conduct research and research training and to establish cooperative arrangements with conventional medical health centers. Public and private resources should be increased to strengthen the infrastructure for CAM research and research training at conventional medical and CAM institutions.


    Education and Training of Health Care Practitioners
    Because the public uses both CAM and conventional health care, the education and training of conventional health professionals should include CAM, and the education and training of CAM practitioners should include conventional health care. The result will be conventional providers who can discuss CAM with their patients and clients, provide guidance on CAM use, collaborate with CAM practitioners, and make referrals to them, as well as CAM practitioners who can communicate and collaborate with conventional providers and make referrals to them.

    The education and training of all practitioners should be designed to ensure public safety, improve health, increase the availability of qualified and knowledgeable CAM and conventional practitioners, and enhance collaboration among them. Education and training programs can do this by developing curricula and programs that facilitate communication and foster collaboration between CAM and conventional students, practitioners, researchers, educators, institutions, and organizations.

    Conventional health professional schools, postgraduate training programs, and continuing education programs should develop core curricula regarding CAM to prepare practitioners to discuss CAM with their patients and clients and help them make informed choices about the use of CAM. The challenges to developing these core curricula include:
    • Professional, organizational, and institutional resistance to change,
    • Lack of funding,
    • Inadequate incentives to adopt the curricula,
    • Logistical design, development, and implementation difficulties,
    • Lack of consensus on curricula,
    • Lack of adequately trained faculty and faculty development, and
    • Limited ability to add to already very full curricula.


    Likewise, CAM education and training programs need to develop core curricula that reflect the fundamental elements of biomedical science and conventional health care as they relate to and are consistent with the CAM practitioners' scope of practice. The challenges to developing such core curricula for CAM education are similar to those stated above.


    Support for CAM Programs, Faculty, and Students
    Access to increased funding and other resources for CAM faculty, curricula, and program development at both CAM and conventional institutions* could result in better CAM education and training, which, in turn, could translate into more skilled practitioners, improved CAM services, and greater patient satisfaction and safety. Faculty development is essential for improved CAM education and training at CAM and conventional institutions. Currently, funding is limited and appears to be directed toward only a small number of curricula and program development projects at largely conventional institutions. Increased Federal, state, and private support should be made available to expand and evaluate CAM faculty, curricula, and program development at accredited CAM and conventional institutions.

    CAM students, institutions, and professional organizations have expressed considerable interest in participating in loan and scholarship programs. Currently, the only CAM students eligible for participation in the Scholarship for Disadvantaged Students program are chiropractic students. No CAM students are eligible for the National Health Service Corps Scholarship program at this time.

    In general, expansion of Federal loan programs to CAM students appears easier to accomplish than participation in the scholarship program. The Department of Health and Human Services (DHHS) should conduct a feasibility study to determine whether appropriately educated and trained CAM practitioners can enhance or expand health care provided by primary care teams. The feasibility study could be followed with demonstration projects to determine what types of CAM practitioners, education and training requirements, practice sites, and minimal clinical competencies result in improved health outcomes


    Additional Education and Training in CAM
    To improve the competency of practitioners and the quality of services, CAM education and training should continue beyond the entry, professional school, or qualifying degree level. However, before establishing new CAM postgraduate education and training programs or expanding current ones, appropriate CAM candidates must be identified and the feasibility, type, duration, and impact of the programs determined.

    Since community health centers represent a unique opportunity for combining education in ethnically, racially, and culturally diverse learning environments with service to medically underserved populations who otherwise might not have access to CAM, current and proposed CAM postgraduate education and training programs affiliated with such centers should be given special consideration.

    Continuing education can provide a powerful means of affecting conventional and CAM practitioners' behavior, thereby enhancing public health and safety. Currently, the number, type, and availability of programs with content appropriate for all practitioners who provide CAM services and products are not sufficient. Therefore, continuing education programs need to be improved and made available to all conventional health professionals as well as to all practitioners who provide CAM services and products.


    Development and Dissemination of Information about CAM
    One of society's greatest achievements-and one of its greatest challenges-has been the dramatic improvement in the development and dissemination of information. Not only does information travel faster, significantly more of it has become available. This is especially true of health information, including information about CAM.

    To ensure public safety in the continually evolving area of CAM, accurate information must be available so that people can make informed choices. This includes choosing the most appropriate type of practitioner, deciding what type of approach can benefit certain conditions, ascertaining the ingredients in a product (such as a dietary supplement), and determining whether ingredients are safe and can assist in maintaining health. Yet far too often information to help make these choices is nonexistent, inaccurate, or difficult to find.

    The ready availability of accurate information is especially important to people who are confronting a life-threatening illness. For someone newly diagnosed with a serious or life-threatening illness, seeking information about their disease and treatment options is often their first course of action. Many people quickly become overwhelmed by the vast array of often conflicting information that is available, and yet for some diseases and conditions, there is a scarcity of reliable information.


    Promoting Accurate, Easily Accessible Information
    To be effective, information must be tailored to the population it seeks to reach. People of different cultural, ethnic, and socioeconomic backgrounds frequently have different views of health and healing, different patterns of use of health care services and products, and different ways of acquiring information. People's views and behavior also vary with their age, literacy, and specific health conditions. Informational materials need to reflect the characteristics and behavior of the target population.

    The Federal government should make accurate and easily accessible information on CAM practices and products available to the public. It can do this by establishing a task force to facilitate the development and dissemination of CAM information within the Federal government and to eliminate existing gaps in information about CAM. In addition, more librarians can be trained to help consumers find information on CAM.

    The Internet has given people access to vast amounts of health care information that would not have been available to them previously, but this technology raises concerns about quality. People may be making life-and-death decisions based on information that is misleading, incomplete, or inaccurate. This is particularly true in the case of CAM, for which a broad base of evidence is not yet available. Establishing a public-private partnership to develop voluntary standards for CAM information on the Internet, and conducting a public education campaign to help people evaluate information, should improve the quality and accuracy of CAM information from this source. Actions should also be taken to protect consumers' privacy.

    Training, licensing requirements, certification, and scope of practice; regulations; and even definitions of CAM practitioners can vary considerably. Therefore, practitioners' qualifications should be readily available to consumers to help them make informed choices about selecting and using practitioners. Information on State regulations, requirements, and disciplinary actions should also be readily available to help ensure consumers' safety.

    Consumers frequently learn about CAM products and services through advertising and marketing. While most advertisers of CAM products and services comply with current laws, misleading and fraudulent health claims do exist. Some people, particularly those who are ill, who have limited language or educational skills, or who lack access to the conventional health care system, are especially susceptible to advertisements that promise to cure a disease, symptom, or problem. Not only are some of these products, services, and treatments ineffective, they may even be harmful, especially if they delay necessary treatment or take money away from persons with limited resources. Efforts to enforce existing laws curbing such abuses should be increased.


    Ensuring the Safety of CAM Products
    One of the most rapidly growing areas in CAM has been the use of dietary supplements. Sales of these products totaled $17 billion in 2000, and more than 158 million consumers used them. Dietary supplements are not subject to the same rigorous testing and oversight required of prescription drugs, which are targeted toward disease conditions. While this has greatly increased the public's access to supplements, it has limited the information required on the label regarding potential risks, benefits, and appropriate use.

    The public expects that products sold in the United States are safe. Since many dietary supplements are purchased without the knowledge or advice of an appropriately trained and credentialed provider, information on ingredients, benefits, appropriate use, and potential risks should be made easily available to consumers at the time of purchase, especially information affecting vulnerable consumers such as children, the elderly, pregnant or nursing women, and people with certain health conditions or compromised immune systems.

    CAM products that are available to U.S. consumers must be safe and meet appropriate standards of quality and consistency. Efforts to ensure the development of analytical methods and reference materials for dietary supplements should be increased. Good Manufacturing Practices for Dietary Supplements should be published expeditiously, followed by timely review of comments and completion of a final rule. The Food and Drug Administration (FDA) will need adequate resources to complete this task. Federal agencies responsible for enforcing current laws monitoring the quality of imported raw materials and finished products intended for use as dietary supplements will also require adequate funding.

    Manufacturers should have on file and make available to the FDA upon request scientific information to substantiate their determinations of safety, and current statutory provisions should be reexamined periodically to determine whether safety requirements for dietary supplements are adequate. An objective process for evaluating the safety of dietary supplement products should be developed by an independent expert panel.

    Reporting of adverse events associated with dietary supplements is voluntary: Manufacturers and distributors are not required to notify the FDA of adverse reactions that have been reported to them. Congress should require dietary supplement manufacturers to register their products and suppliers with the FDA. Until this requirement is in place, the agency should encourage voluntary registration so that manufacturers, suppliers, and consumers can be notified promptly if a serious adverse event is identified. Dietary supplement manufacturers and suppliers should be required to maintain records and report serious adverse events to the FDA.

    Additional resources and support are needed to simplify the adverse event reporting system for dietary supplements. The system should be made easier to use, its database streamlined to permit timely review and follow-up on reports received, and its outreach to consumers and health professionals (including poison control centers, emergency room physicians, CAM practitioners, and midlevel marketers) improved. Simplifying the adverse event reporting system will improve both manufacturers' and consumers' awareness of and participation in voluntary reporting.

    To ensure the safety of the public and to give consumers confidence in the products they are using, Congress should periodically evaluate the effectiveness, limitations, and enforcement of the Dietary Supplement Health and Education Act of 1994 and take appropriate action when needed.


    Access and Delivery
    The Commission heard numerous concerns about access to CAM practitioners and products, including access to qualified CAM practitioners, state regulation of CAM practitioners, integration of CAM and conventional health care, collaboration between CAM and conventional practitioners, and the cost of CAM services. Many people expressed a desire for increased access to safe and effective CAM, along with conventional services. The Commission recognizes that Americans want to be able to choose from both conventional and CAM practices and that they want assurances that practitioners are qualified.


    Improving Access to CAM
    As is true of conventional health care, many factors influence access to CAM services and their delivery. The distribution and availability of local providers, regulation and credentialing of providers, policies concerning coverage and reimbursement, and characteristics of the health care delivery system all affect the quality and availability of care and consumer satisfaction. Equally important, access is limited by income, since most CAM practices and products are not covered under public or private health insurance programs. Moreover, access is more difficult for rural, uninsured, underinsured, and other special populations. The issue of access is further compounded by the lack of scientific evidence for many CAM practices and products.

    A better understanding of how the public uses CAM is needed to determine what can be done to improve access to safe and effective CAM within the context of other public health and medical needs. In additional, more information is needed on what constitutes "appropriate access" to CAM services.

    A few community health centers have begun to use the services of CAM practitioners, such as chiropractors, naturopathic physicians, and acupuncturists. These centers might provide models for other community health centers and public health service programs, but first their impact on access to care and the cost-benefit picture needs to be determined. Hospice care for the terminally ill is another important model of care that should be evaluated. Some hospice programs are beginning to include CAM practitioners on the treatment team. The Federal government should support demonstration projects that integrate safe and effective CAM services into the health care programs of hospices and community health centers.

    Special populations, such as racial and ethnic minorities, and vulnerable populations, such as the chronically and terminally ill, have unique challenges and needs regarding access to CAM. Yet efforts to address their access to CAM must take into consideration their need for access to conventional health care, and scare resources must be allocated carefully. The Federal government should facilitate and support the evaluation of CAM practices to help meet the health care needs of these populations and support practices found to be safe and effective. Ways of supporting the practice of indigenous healing in the United States and improving communication among indigenous healers, conventional health care professionals, and CAM practitioners should also be identified.

    Now is the time to look at policy options for the future and to design strategies for addressing potential issues of access and safety. A variety of issues need to be considered: protecting the public, maintaining free competition in the provision of CAM services, and maintaining the consumer's freedom to choose appropriate health professionals. The need to maintain CAM styles of practice, rather than allowing them to be subsumed into the conventional medical model, also must be considered when addressing the issue of access.

    To improve consumers' access to safe and effective CAM practices and qualified practitioners, and to ensure accountability, the Federal government should evaluate current barriers and develop strategies for removing them. It should also help states evaluate the impact of state legislation on access to CAM practices and on public safety. Health care workforce data and other studies can help identify current and future health care needs and the relevance of safe and effective CAM services to those needs.


    Ensuring CAM Practitioners' Accountability to the Public
    States should consider whether a regulatory infrastructure for CAM practitioners is necessary to promote quality of care and patient safety and to ensure practitioners' accountability to the public. The Federal government should offer assistance to states and professional organizations in developing and evaluating guidelines for practitioner accountability and competence, including regulation of practice and periodic review and assessment of the effects of regulations on consumer protection. When appropriate, states should implement provisions for licensure, registration, and exemption that are consistent with a practitioner's education, training, and scope of practice.

    Nationally recognized accrediting bodies should evaluate how health care organizations are using CAM practices and develop strategies for the safe and appropriate use of qualified CAM practitioners. In partnership with other public and private organizations, they should evaluate the present use of CAM practitioners in health care delivery settings and develop strategies for their appropriate use in ways that will benefit the public. Current standards and guidelines should be reviewed to ensure safe use of CAM practices and products in health care delivery organizations.


    Coverage and Reimbursement
    The coverage and reimbursement policies of public and private organizations that pay for, provide, or insure conventional health care services have played a crucial role in shaping the health care system-and they will play an increasingly important role in determining the future of CAM and its place in the nation's health care system

    Coverage of CAM services and products varies among purchasers of health plans, but employer-sponsored plans appear more likely than others to offer them. These plans generally offer a chiropractic benefit, and a growing number cover acupuncture and massage therapy. When offered, CAM coverage often places a ceiling on the number of visits, restricts the clinical applications, and specifies the qualifications of the practitioner. Typically, CAM is offered as a supplemental benefit rather than as a core or basic benefit. Benefit designs also include discount programs, in which covered individuals pay reduced fees for services provided by a network of CAM practitioners, and annual benefit accounts against which services may be purchased.


    Barriers to Coverage
    Overcoming barriers to coverage and reimbursement will require first amassing scientific evidence to assess the benefits and cost-effectiveness of CAM and then giving equitable, impartial consideration to those practices and products proven to be safe and effective.

    Gathering a body of evidence will require DHHS, other Federal agencies, states, and private organizations to develop a health services research agenda and to increase funding for studies of the outcomes of CAM interventions in treating acute, chronic, and life-threatening conditions. Research, demonstrations, and evaluations should focus not only on safety but also on clinical effectiveness, costs, and the ratio of costs to benefits. In addition, health services research can be used to support the development and study of models for providing safe and effective CAM within the nation's health care system. Prototypes should include integrative and collaborative models for CAM and conventional health care, comparisons of conventional and CAM treatments for the same condition, and evaluations of various combinations of services and products. Information on health services research should be made available through the clearinghouse of NCCAM.

    To conduct health services research, investigators need data from claim and encounter forms, specifically data coded using nationally accepted, standardized systems. National coding systems such as Common Procedure Terminology recognize some CAM interventions, but they are currently limited in scope and specificity. More recently, a coding system for CAM procedures, services, and products-ABCcodes-has been developed and is being used in a number of settings. The National Committee for Vital and Health Statistics and DHHS should authorize a national coding system that supports standardized data on CAM for use in clinical and health services research. In addition, the coding system should support practitioners and insurers who cover CAM services in complying with the electronic claims requirements of the Health Insurance Portability and Accountability Act.

    Any medical or health care intervention that has undergone scientific investigation and has been shown to improve health or functioning, or to be effective in treating the chronically or terminally ill, should be considered for inclusion in health plan coverage. To accomplish this, health insurance and managed care organizations should modify their benefit design and coverage processes in order to offer purchasers health benefit plans that include safe and effective CAM interventions. Similarly, purchasers should enhance the processes they use to develop health benefits and give consideration to safe and effective CAM interventions. DHHS can support these efforts by convening work groups and conferences to assess the state-of-the-science of CAM services and products and to develop consensus and other types of guidance for Medicare, other public and private purchasers, health plans, and even consumer representatives.

    Coverage of and reimbursement for most health care services are linked to a provider's ability to furnish services legally within the scope of his or her practice. This legal authority to practice is given by the state in which services are provided. Thus, even if insurers, managed care organizations, and other health plan sponsors are interested in covering safe, cost-effective CAM interventions, they cannot do so unless properly licensed, or otherwise legally authorized, practitioners are available in a state. State governments are encouraged to consider how regulation of CAM practitioners could affect coverage and third-party reimbursement of safe and effective CAM interventions.


    Criteria for Using CAM
    Once a CAM service is covered, health insurers, managed care organizations, and government agencies must be able to determine whether use of the service or product in a particular situation is generally accepted or investigational, and whether the service or product is medically necessary in that situation. Few criteria are available to guide practitioners in deciding the medical or clinical necessity of CAM interventions. DHHS, preferably through a centralized CAM office, should work with health care and professional associations, CAM experts, health insurance and managed care organizations, benefits experts, and others to guide changes in health plan coverage for safe and effective CAM services and products and to develop criteria for use of CAM interventions.

    Purchasers, health insurers, and managed care organizations will need CAM expertise when developing changes in coverage and reimbursement policies that involve CAM. CAM practitioners and experts should be included on advisory bodies and work groups considering CAM benefits and other appropriate health benefit issues.


    CAM in Wellness and Health Promotion
    In recent years, people have come to recognize that a healthful lifestyle can promote wellness and prevent illness and disease, and many people have used CAM approaches to attain this goal. Wellness is defined in many ways, but all agree that it is more than the absence of disease. Wellness can include a broad array of activities and interventions that focus on the physical, mental, spiritual, and emotional aspects of one's life. The concomitant rise in interest in CAM and in wellness and prevention presents many new and exciting opportunities for the health care system.


    CAM's Role in Attaining the Nation's Health Goals
    Since 1979, the U.S. Public Health Service has led a national initiative to define goals and objectives for the nation's health. As is clear from the resulting Healthy People series, a wide range of disciplines and social institutions is needed to improve health and wellness, prevent illness and disease, and manage disabilities and chronic conditions. The effectiveness of the health care delivery system in the future will depend upon its ability to make use of all approaches and modalities that provide a sound basis for promoting health.

    There is evidence that certain CAM practices, such as acupuncture, biofeedback, yoga, massage therapy, and tai chi, as well as certain nutritional and stress reduction practices may be useful in contributing to the achievement of the nation's health goals and objectives. Federal agencies and public and private organizations should evaluate CAM practices and products that have been shown to be safe and effective to determine their potential for promoting wellness and helping to achieve the nation's health promotion and disease prevention goals. Demonstration programs should be funded for those determined to be beneficial

    The Federal government, in partnership with public and private organizations, should support the development of a national campaign that teaches and encourages healthful behaviors for all Americans, including children. The campaign would focus on improving nutrition, promoting exercise, and teaching stress management. Safe and effective CAM practices and products should be included, where appropriate. The role of safe and effective CAM practices and products in the workplace should also be evaluated, and incentives should be developed to encourage the use of those found to be beneficial.

    The application of CAM wellness and prevention practices to the management of chronic disease and disabilities is a largely unexplored area. CAM principles and practices may be useful not only in preventing some of these diseases and conditions, but also in enhancing recovery and preventing further illness. Increased research in this area will help to determine how CAM principles and practices can best be used to meet the goals of the health care system. DHHS and other Federal agencies should fund demonstration projects to evaluate the clinical and economic impact of comprehensive health promotion programs that include CAM. These studies should include underserved and special populations.


    Wellness and Health Promotion in Programs for Special and Vulnerable Populations
    Early interventions that promote the development of good health habits and attitudes could help prevent many of the negative behaviors and lifestyle choices that begin in childhood or adolescence. Poor dietary habits, lack of exercise, smoking, suicide, substance abuse, homicide, and depression are epidemic among young people. The Commission believes that it is time for wellness and health promotion to be made a national priority. CAM practices and products that have been shown to be appropriate for children and young people should be included in this effort, which must involve all sectors of the community, particularly schools.

    The Federal government funds many programs that serve vulnerable populations, such as children, the poor, and the elderly. The programs have a direct impact on the health and quality of life of the people they serve, and they may benefit from a wellness and prevention component that includes safe and effective CAM practices and products. The agencies that administer these programs should evaluate safe and effective CAM practices and products to determine their applicability to the programs and fund demonstration projects for those found to be beneficial.

    Federally funded health care delivery programs, such as the Department of Veterans Affairs, The Department of Defense, the Indian Health Service, community and migrant health centers, maternal and child health programs, and school health programs, should also evaluate the applicability of CAM wellness and prevention activities to their services. Demonstration programs should be funded for CAM practices and products found to be beneficial to these populations. Other Federal, State, public, and private health care delivery systems and programs would also be well-advised to evaluate CAM practices and products to determine their applicability to programs and services that help promote wellness and health.

    The Secretary of Health and Human Services should bring together public and private health care organizations to evaluate the contribution of safe and effective CAM practices and products to wellness and health and to determine how they may be used in health systems and programs, especially in the nation's hospitals and long-term care facilities and in programs serving the aged, persons with chronic illness, and those at the end of life.

    CAM and conventional health professional training programs should offer students training and education in self-care and lifestyle decision-making, both to improve practitioners' health and to enable them to impart this knowledge to their patients or clients.


    Coordinating Federal CAM Efforts
    Integration of safe and effective CAM practices and products into the nation's health care system will require an ongoing, coordinated Federal presence. Establishment of a centralized office is the most effective means of accomplishing this goal. Responsibilities of the office should include:
    • Coordinating Federal CAM activities,
    • Serving as a Federal CAM policy liaison with conventional health care and CAM professionals, organizations, educational institutions, and commercial ventures,
    • Planning, facilitating, and convening conferences, workshops, and advisory groups,
    • Acting as a centralized point of contact for the public, CAM practitioners, conventional health care providers, and the media,
    • Facilitating implementation of the recommendations and actions of the White House Commission on Complementary and Alternative Medicine Policy, and
    • Exploring additional and emerging topics not included in the Commission's Executive Order.



    The Commission recommends that the President, Secretary of Health and Human Services, or Congress create an office to coordinate Federal CAM activities and to facilitate the integration of safe and effective practices and products into the nation's health care system. The office should be established at the highest possible appropriate level in DHHS and be given sufficient staff and budget to meet its responsibilities. The office should charter an advisory council whose members would include representatives of the private and public sectors as well as CAM and conventional practitioners with the necessary expertise, diversity of backgrounds, and training to guide and advise the office about its activities.


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