on Complementary and Alternative Medicine. 9. completion of final 1.5 The National Center for Complementary and Alternative Medicine, through its …
Draft Final Recommendations White House Commission on Complementary and Alternative Medicine CAM in Wellness and Health Promotion Recommendation 1: Safe and effective CAM practices should be utilized to help achieve the Nations health promotion and disease prevention goals and to promote wellness throughout life Actions 11 CAM practices that improve nutrition, promote exercise, and teach stress management should be integrated into the school curriculum for children from kindergarten to 12th grade 12 Federal agencies such as the Health Resources and Services Administration, the Centers for Disease Control and Prevention, and the Department of Agriculture should incorporate CAM practices into national guidelines on wellness and prevention practices for children 13 The Department of Health and Human Services should conduct a national campaign that includes public service announcements and involvement of public figures to teach and encourage healthy behaviors among children 14 Federal
agencies, in partnership with the business community, should develop incentives for schools to make available healthier school lunches and snacks, and to limit the sale and eliminate the advertising of high-fat snacks, soft drinks, and other products that do not contribute to healthy lifestyles 15 The Healthy People Consortium should include CAM professionals in its review of the 10 leading health indicators and develop strategies to encourage the use of CAM practices in these areas 16 Questions on the extent and intended use of CAM products and practices should be included in the national surveys and other assessment tools including the Nationals Health and Interview Survey, the Nationals Health and Nutrition Examination Survey, and the Medical Expenditure Panel Survey, and these data should be incorporated into the Healthy People 2020 goals and objectives Recommendation 2: Research on the role of CAM in wellness and health promotion, the application of CAM principles and practices,
and the role of CAM practitioners in the management of chronic disease should be expanded Actions 21 DHHS should fund demonstration projects that include underserved and special populations to evaluate the clinical and economic impact of comprehensive health promotion programs that include CAM 22 The Federal government and private health organizations should evaluate CAM approaches that are currently being used for wellness and health promotion to determine their effectiveness and applicability to the management of chronic disease Recommendation 3: Safe and effective CAM practices used in the workplace to promote wellness and health should be expanded
Draft Final Recommendations White House Commission on Complementary and Alternative Medicine Actions 31 CAM wellness and prevention activities should be included in Federal worksite wellness and health promotion programs and Federal health coverage plans 32 Federal agencies, in conjunction with the business community, should develop
incentives for employers to include CAM wellness and prevention activities in their workplace wellness programs and health coverage, and to decrease insurance premiums for those that participate in them Recommendation 4: Public, private, and Federal health care delivery systems and health-related programs should incorporate safe and effective CAM practices into their services to help promote wellness and health Actions 41 The Secretaries of the Department of Health and Human Services and the Department of Agriculture, and the Commissioner of the Administration for Children and Families, should establish task forces to develop strategies for incorporating CAM wellness and health promotion activities and professionals into Federal health programs such as Head Start, Meals on Wheels, The Special Supplemental Nutrition Program for Women, Infants and Children, the Healthy Mothers/Healthy Babies Program, and the State Childrens Health Insurance Program 42 Federal health care delivery systems
in the Department of Defense, Department of Veterans Affairs, Indian Health Service, and community and migrant health centers should establish task forces to develop strategies that will incorporate CAM wellness and health promotion activities and professionals in their services 43 Funding should be provided for demonstration projects to evaluate the impact of CAM practices in wellness, health promotion, chronic illness, and end-of-life programs offered by the Department of Veterans Affairs and Department of Defense 44 The Secretary of Health and Human Services should establish a task force to develop strategies for incorporating CAM wellness and health promotion activities in the nations hospitals and long-term care facilities and in programs serving the aging, the dying, and those with chronic illness 45 CAM and conventional health professional training programs should include the teaching of self-care and lifestyle decision making to improve practitioners health and to enable
practitioners to impart this knowledge to their patients or clients Coordination of Research Recommendations Recommendation 1: Federal agencies should receive increased funding for clinical, basic, and health services CAM research Actions 11 All Federal agencies with research or related health care missions should increase their research and related activities with respect to CAM and make them known to CAM professionals Activities should include funding initiatives such as requests for applications and proposals; CAM-focused offices or centers; CAM-focused staff
2
Draft Final Recommendations White House Commission on Complementary and Alternative Medicine positions; CAM planning and advisory committees or the representation of qualified CAM professionals on such groups 12 Congress should provide adequate public funding for research on frequently used of promising CAM products that would be unlikely to receive a patent and therefore unlikely to attract private research support
Recommendation 2: Congress and the Administration should enact legislative and administrative reforms to provide greater incentives to stimulate private sector investment in CAM research on products that may not be patentable Actions 21 Incentives to stimulate private sector investment in CAM research should focus on 1 research on dietary supplements and other natural products that may not be patentable; 2 research on other CAM products that may not be patentable, including therapeutic devices; and 3 the development of analytical methods for producing better quality CAM products 22 The Federal and private sectors should provide support for workshops to discuss the research needed by regulatory agencies for their review and approval processes for CAM products and devices 23 Federal agencies should develop outreach programs to inform manufacturers of CAM products and devices about the Federal research support available to private industry and how the agency can assist them 24
Manufacturers of CAM products and devices should become acquainted with potential sources of research funding and the requirements they must meet to access such resources successfully Recommendation 3: Federal, private, and nonprofit sectors should support research on CAM practices that build on lifestyle and self care, and on therapeutic approaches that integrate CAM and conventional medicine Actions 31 The Federal government should stimulate private investment in research on CAM modalities and approaches that are designed to improve self care and wellness behaviors Recommendation 4: Federal, private, and nonprofit sectors should support new and innovative CAM research on CAM practices and products, and on core questions posed by frontier areas of scientific study associated with CAM that might expand our understanding of health and disease Actions 41 The Federal, private, and nonprofit sectors should support more research on 1 complex compounds/mixtures frequently found in CAM
products, 2 clinical interventions consisting of multiple treatments, 3 patient-practitioner interactions, and 4 individualizing treatments
3
Draft Final Recommendations White House Commission on Complementary and Alternative Medicine 42 NCCAM, assisted by the National Science Foundation, the Institute of Medicine, the World Health Organization, or other Federal or non-Federal body, should conduct a review on core research questions associated with CAM that are outside the current research paradigm 43 The National Institute of General Medical Sciences of the NIH, the Department of Energy, the Department of Defense, and the National Science Foundation are among the Federal organizations that should consider contributing collaboratively or independently to the support of research on core questions in areas described in many CAM systems 44 Multidisciplinary workshops and expert panels should be convened by Federal, private and nonprofit organizations, collaboratively or independently,
to explore the challenges in design and methodology presented by research questions in CAM areas that are outside the current research paradigm Recommendation5: It should be duly noted that human subjects participating in CAM related clinical trials are entitled to the same protections as required in conventional medical research Actions 51 Licensed practitioners using CAM systems and modalities who wish to conduct or collaborate in clinical research should follow the same requirements as in conventional medical research They should develop, or partner with a research institution to develop, a scientifically valid research protocol and obtain IRB approval to ensure that they meet accepted standards of ethical conduct and their responsibilities to protect human subjects 52 Accredited CAM institutions and CAM professional organizations should establish IRBs where possible, ad guide their colleagues and members to utilize the IRB process, which is required to conduct clinical research 53
IRBs that review CAM research studies should include the expertise of qualified CAM professionals in the review 54 Research institutions, NIH Institutes and Centers, and other Federal research and health care agencies should be more proactive in developing programs that 1 provide opportunities for expert review of promising CAM practice-based observational data by experienced researchers, 2 stimulate practitioner response to the opportunities offered by the programs and 3 facilitate communication and stimulate partnerships between CAM practitioners and conventionally-trained researchers in designing and implementing clinical studies Recommendation 6: State professional regulatory bodies should include language in their guidelines stating that licensed or other authorized practitioners will not be sanctioned solely because they are engaged in CAM research if they are 1 engaged in research that is approved by an appropriately constituted IRB, 2 are following the requirements for the
protection of human subjects, and 3 are meeting the same licensing or other authorizing standards of practice to which all similarly licensed or authorized practitioners are held
4
Draft Final Recommendations White House Commission on Complementary and Alternative Medicine Recommendation 7: To facilitate CAM integration into the health care system, increased efforts should be made to strengthen the emerging dialogue among CAM and conventional medical practitioners, researchers and accredited research institutions; Federal and state research, health care, and regulatory agencies; the private and nonprofit sectors; and the general public Actions 71 CAM and conventional medical researchers and practitioners should adhere to the same high standards of quality and ethics in all aspect of research and related activities 72 Federal agencies should develop programs to stimulate cooperation and partnerships between CAM and conventional medical professionals and accredited institutions 73
Committees reviewing or advising on research, journal submissions, regulatory compliance, and health insurance coverage in both the public and private sectors should include as members or consultants trained, experienced, and properly qualified CAM health care professionals 74 Multidisciplinary conferences, workshops, and expert panels on CAM research and related activities, including research methodology, should be supported independently or collaboratively by the public, private, and nonprofit sectors 75 The nonprofit sector and the private sector should create funding partnerships, whether independently or with Federal agencies, to augment support for CAM research, research infrastructure and training, research conferences, and information dissemination 76 The Federal government should support research, including population-based research, to learn more about why people use CAM practices and products How they determine the safety and effectiveness of the practices and products they
use, and what they find satisfying or unsatisfying about them 77 To benefit patients and future research protocol development and to add to our knowledge about the use of CAM, IRBs should consider requiring that all research subjects be asked about their use of herbal or other dietary supplements, and hospitals should consider requiring that all inpatients and outpatients be asked about their supplement use 78 Federal agencies supporting biomedical and health services research should develop orientation and training programs for public representatives to enhance the effectiveness of their participation on advisory committees concerned with CAM Recommendation 8: Public and private resources should be increased to strengthen the CAM research and research training infrastructure at conventional medical and CAM institutions and to expand the cadre of basic, clinical, and health services researchers who are knowledgeable about CAM and have received rigorous research training Actions 81 The
leadership at accredited CAM and conventional medical institutions should develop programs that examine CAM research questions and that stimulate cross-
5
Draft Final Recommendations White House Commission on Complementary and Alternative Medicine institutional collaborations involving faculty and students in research and research training The leadership at accredited CAM and conventional medical institutions should support joint research and professional education and training programs to enhance the quality and clinical relevance of CAM research and link the research with evidence-based education and training of practitioners Federal health agencies with research training programs and responsibilities that encompass CAM-related questions should be given adequate support to increase research training in CAM Existing resources, such as NCCAM-supported centers and the National Center for Research Resources General Clinical Research Centers should be utilized to increase opportunities
to conduct clinical research and training on CAM and examine the integration of CAM into the clinical setting Federal support should be increased for career development awards, including those that enable investigators focusing on CAM to develop into independent investigators and faculty members, and mid-career awards that provide the time required to mentor new CAM investigators
82
83 84
85
Recommendation 9: Public and private resources should be used to support, conduct, and update systematic reviews of the peer-reviewed research literature on the safety and efficacy of CAM practices and products Actions 91 The Agency for Health Care Research and quality should expand its Evidence-based Practice Center systematic reviews on CAM systems and treatments for use by private and public entities in developing tools, such as practice guidelines, performance measures, and review criteria, and for identifying future research needs 92 NCCAM should issue a comprehensive and regularly updated
summary of current clinical evidence on the safety and efficacy of CAM systems and treatments for Health care practitioners and the public Education and Training Recommendation 1: The education and training of CAM and conventional practitioners should be improved to ensure public safety, and to increase the availability of qualified CAM practitioners and knowledgeable conventional practitioners Actions 11 Conventional health professional schools, postgraduate training programs, and continuing education programs should develop core curricula of knowledge about CAM in conjunction with CAM experts and CAM institutions so that conventional health professionals can discuss CAM with their patients and clients and guide them in the appropriate use of CAM
6
Draft Final Recommendations White House Commission on Complementary and Alternative Medicine 12 All CAM education and training programs should develop curricula that reflect the fundamental elements of biomedical science and conventional
practice in order to ensure safe and beneficial care of patients 13 All CAM and conventional education and training programs should develop curricula and other methods to facilitate communication and foster collaboration between CAM and conventional students, practitioners, researchers, educators, institutions and organizations 14 Increased Federal, state, and private sector support should be made available to expand CAM faculty, curricula, and program development at accredited CAM and conventional institutions 15 The eligibility of CAM students for existing loan and scholarship programs should be expanded 16 The Department of Health and Human Service should conduct demonstration projects to determine the feasibility of CAM students participating in the National Health Service Corps scholarship program 17 The Department of Health and Human Services and other Federal Departments and Agencies should convene conferences of the leaders of CAM, conventional health, public health, evolving
health professions, and the public; of educational institutions; and of appropriate organizations to facilitate establishment of CAM education and training Subsequently, the guidelines should be made available to the states and professions for their consideration 18 Demonstration projects of residencies and postgraduate training for appropriately educated and trained CAM practitioners should be conducted to determine the feasibility of such programs and their impact on clinical competency, quality of health care, and collaboration with conventional providers 19 All practitioners who provide CAM services and products should consider completing appropriate CAM continuing education programs to enhance and protect the publics health and safety
CAM Information Development and Dissemination
Recommendation 1: The availability of reliable, useful, and easily accessible information for the public on CAM practices and products should be enhanced Actions 11 The Secretary of Health and Human
Services should establish a task force to enhance the development and dissemination of CAM information within the Federal government and to eliminate existing gaps in CAM information The task force should include consumers, CAM providers, scientists, and conventional health care practitioners Resources should subsequently be provided to close identified gaps and improve the availability, coordination, and dissemination of information 12 All Federal Departments and Agencies with missions or activities relevant to CAM should 1 develop informational materials about CAM that are easy to understand and use; and 2 support and collaborate with national and local community leaders and CAM leaders and organizations to identify strategies for enhancing the
7
Draft Final Recommendations White House Commission on Complementary and Alternative Medicine development, availability, and accessibility of information on the safety and effectiveness of CAM products 13 Increased funding should be
provided to the National Library of Medicine and the American Library Association to expand training of librarians to include helping consumers find information on CAM 14 The Secretary of Health and Human Services should direct resources to streamline the process of identifying and making available relevant, high-quality CAM information from other countries and in other languages Recommendation 2: The quality and accuracy of CAM information on the internet should be improved Actions 21 The Secretary of Health and Human Services should form a public-private partnership to review new and existing websites and to develop voluntary standards promoting accuracy, fairness, comprehensiveness, and timeliness of information on CAM websites, as well as the disclosure of sources of support and any conflicts of interest Sites reviewed and found in compliance with the standards could publicize the fact and display a logo denoting their merit 22 Funding should be provided to the Department of Health
and Human Services and the Department of Education to conduct a joint public education campaign that teaches consumers how to evaluate health care information, including CAM information, on the internet and elsewhere 23 Congress should protect consumers privacy by requiring all health information sites, including CAM sites, to disclose whether they track users and if so, how that information is used and stored, including whether it is sold to third parties Recommendation 3: Information on the training and education of providers of CAM services should be made easily available to the public Actions 31 States should require all persons providing CAM services to make information regarding their level and scope of training easily available to consumers 32 States should make information on state guidelines, requirements, licensure, certification, and disciplinary actions of health providers, including CAM providers, available and easily accessible to the public Recommendation 4: CAM products
that are available to US consumers should meet or exceed minimum standards of quality and consistency Actions 41 The efforts of both the public and private sectors to ensure the development, validation, and dissemination of analytical methods and reference materials for dietary supplements should be enhanced and accelerated 42 The proposal concerning Good Manufacturing practices for Dietary Supplements should be published expeditiously, followed by a timely review of comments and
8
Draft Final Recommendations White House Commission on Complementary and Alternative Medicine completion of final rule The Food and Drug Administration should be provided with adequate resources to complete this complex task 43 Adequate funding should be provided to appropriate Federal agencies, including US Customs and Food and Drug Administration inspection authorities, to enforce current laws monitoring the quality of imported raw materials and finished products intended for use as dietary supplements
44 Manufacturers should make available scientific information to substantiate their determinations of safety, and current statutory provisions should be periodically reexamined to determine whether safety requirements for dietary supplements are adequate Recommendation 5: The public should have accurate information on the quality and safety of CAM products Actions 51 Congress and the Department of Health and Human Services should expeditiously solicit further public input on the labeling of dietary supplements, followed by proposed rulemaking, and/or appropriate oversight and legislative reform by Congress so that consumers have truthful, complete, and scientifically valid information on the benefits and appropriate uses of dietary supplements on the product label and at the point of sale 52 Congress should provide additional support to the Federal Trade Commission to 1 expand efforts to identify false and deceptive advertising of CAM- related health services and products and take
appropriate enforcement action when necessary; 2 use CAM experts in the process of examination of CAM-related advertising, 3 increase activities to help consumers distinguish useful and reliable information from deceptive and unsubstantiated advertising in all forms of marketing and advertising, including at the point of purchase; and 4 seek additional public comment on the benefits and potential problems in the advertising of CAM-related services and products 53 Current provisions requiring disclosure of material facts by manufacturers of CAM products should be enforced and manufacturers should meet their responsibility to disclose material facts so that the public will know about known risks and welldocumented significant interactions 54 An independent review board should be established to develop objective methods of evaluating and reviewing the safety of dietary supplements 55 The Food and Drug Administration and other agencies with regulatory responsibilities should be provided
with additional resources to 1 enforce current requirements regarding labeling of dietary supplements, 2 enforce current provisions requiring that dietary supplements be labeled in English, even if the same information is also included in another language, and 3 employ additional professionals with expertise in dietary supplements Recommendation 6: The collection and dissemination of information about adverse events stemming from the use of dietary supplements should be improved
9
Draft Final Recommendations White House Commission on Complementary and Alternative Medicine Actions 61 Congress should require dietary supplement manufacturers and suppliers to register with the Food and Drug Administration and the agency should encourage voluntary registration until such a requirement is in effect so that manufacturers and suppliers can be promptly notified if a serious adverse event is identified 62 Recent congressional support for improving the Food and Drug Administrations adverse
events reporting system should be enhanced by requiring dietary supplement manufacturers and suppliers to maintain records and report serious adverse events to the agency 63 Additional resources and support should be provided to the Food and Drug Administration to 1 simplify the adverse event reporting system for dietary supplements to make it easier to use; 2 streamline the database for timely review and follow-up on received reports, and 3 increase outreach activities to consumers, health professionals including poison control centers, emergency room physicians, CAM practitioners, and mid-level marketers in order to improve both manufacturers and the publics awareness of and participation in voluntary event reporting Access to and Delivery of CAM Recommendation 1: Access to qualified and competent practitioners, and to safe, effective, affordable CAM services and beneficial CAM products should be improved for all Americans Recommendation 2: Practitioners who provide CAM services and
products should be regulated by states using a standard, understandable framework that ensures accountability to the public and that contains provisions for registration, licensure, and exemptions Actions 1 The Secretary of Health and Human Services should convene a national policy advisory committee to address issues related to the regulation of CAM practitioners, provide guidance to the states, and provide a forum for dialogue on other issues related to maximizing access 2 The Federal government, in collaboration with states, should assist CAM practitioners in developing consensus on the definition of their profession or practice and standards of practice, including educations and training Their conclusions should be considered by states and regulatory bodies in determining the appropriate status of these practitioners, including registration, licensure, or exemption 3 The Department of Health and Human Services advisory committee should work closely with state legislatures,
regulatory boards, and CAM practitioners to develop guidelines for the regulation and oversight of licensed and registered practitioners who utilize CAM services and products
10
Draft Final Recommendations White House Commission on Complementary and Alternative Medicine 4 Nationally recognized accrediting bodies of health care organizations and facilities should establish ongoing access to CAM expertise to ensure that accreditation standards reflect emerging developments in CAM 5 Nationally recognized accrediting bodies of health care organizations and facilities should clarify how accreditation requirements apply to CAM and should promote appropriate collaboration with CAM practitioners in order to foster understanding and awareness of CAM 6 The Department of Health and Human Services and other appropriate Federal agencies should use health care workforce data; data from national surveys on CAM, and regional public health reports on CAM activities to identify current and future
health care needs that qualified CAM practitioners my help address 7 The Federal Government should convene conferences on effective approaches to the integration of safe and beneficial CAM practices and products into conventional medical setting and make this information available to practitioners and the public 8 The Secretary of Health and Human Services should identify common uses and practices of indigenous healing in the United States and recommend ways of improving collaboration between indigenous healing traditions and the current health care system This should be done in a manner that protects the cultural heritage of indigenous healing traditions, educates health care practitioners, includes members of indigenous groups, and maximizes access to qualified practitioners, safe and beneficial services, and effective products Coverage and Reimbursement Recommendation 1: Evidence should be developed and disseminated as to the costeffectiveness of CAM interventions as well as optimum
models for complementary and integrated care Actions 11 The Secretary of Health and Human Services should convene a joint public and private task force to identify and set priorities for studying health services issues related to CAM and to help purchasers and health plans make prudent decisions regarding coverage of and access to CAM 12 Federal agencies, states, and private organizations should increase funding for health services research, demonstrations, and evaluations related to CAM, including outcomes of CAM interventions, coverage and access, effective sequencing and integration with conventional therapies, effective models for service delivery, and the use of CAM in underserved, vulnerable, and special populations 13 Federal, state, and private entities should fund health services research on the costs and cost-effectiveness of CAM interventions and wellness programs 14 The Secretary of Health and Human Services should conduct a study to analyze nationally used coding
processes, CAM coding systems, and the issues associated with a single merged versus separate coding, systems, and make recommendations
11
Draft Final Recommendations White House Commission on Complementary and Alternative Medicine Further, the Secretary should facilitate implementation of the studys recommendations 15 The National Center for Complementary and Alternative Medicine, through its clearinghouse, should provide information on health services research, demonstrations, and evaluations of CAM services and products 16 Health professional, service, insurance, managed care, and other industry associations and organizations should provide their members with information about CAM and incorporate CAM onto the agendas of their professional meetings 17 Public agencies and private organizations should support the development of informational programs on CAM targeted to health plan purchasers and sponsors, health insurers, managed care organizations, consumer groups, and others
involved in the provision of health care services 18 Congress should request periodic reports form appropriate Federal departments on the status of and impediments to coverage and reimbursement of CAM services and products for Federal beneficiaries, Federal employees, military personnel, veterans, and eligible family members and retirees Recommendation 2: Purchasers, insurers, and managed care organizations should extend health plan coverage to safe and effective CAM services and products provided by qualified practitioners Actions 21 Health insurance and managed care companies should modify their benefit design and coverage processes in order to offer purchasers products that include safe and effective CAM interventions 22 Employers, federal agencies, other purchasers and sponsors should enhance the processes they use to develop health benefits and give consideration to safe and effective CAM interventions 23 Public and private organizations should include CAM practitioners and
experts on advisory bodies, workgroups, and committees considering CAM benefits and other health care coverage 24 CAM practitioners, their associations and their institutions should identify opportunities and actively seek to participate on public and private advisory bodies, especially in areas of health services research on CAM and coverage of CAM interventions 25 DHHS, preferably the federal CAM coordinating office when established, should maintain a list of opportunities for CAM experts to participate on advisory committees and other workgroups 26 Congress and the Executive Branch should amend the federal tax code to include CAM in the favorable tax treatment of health benefits granted to employers 27 The Secretary of Health and Human Services should direct agencies under his authority to convene workgroups and conferences to assess the state-of-the-science of CAM services and products and to develop consensus and other guidance on their use 28 Health insurers, managed care
organizations, CAM professional associations, CAM experts, private organizations that develop medical criteria, and federal agencies
12
Draft Final Recommendations White House Commission on Complementary and Alternative Medicine should support cooperative efforts to develop criteria and guidelines for the use of CAM services and products 29 State governments should address barriers to third party converge of safe and beneficial CAM interventions that stem from the practitioners need for legal authority to provide those interventions Coordinating Federal CAM Efforts Recommendation 1: The President, Secretary of Health and Human Services, or Congress should create and office to coordinate and facilitate integration of safe and effective complementary and alternative health care practices and products into the nations health care system Actions 11 The office should be established at the highest possible and most appropriate Federal level, with sufficient staff and budget to meet its
responsibilities 12 The office should charter and advisory council with members from both the private and public sectors to guide and advise the office about its activities 13 The offices responsibilities should include, but not be limited to, coordinating Federal CAM activities; serving as a Federal CAM policy liaison with conventional health care and CAM professionals, organizations, institutions, and commercial ventures; planning, facilitating, and convening conferences, workshops, and advisory groups; acting as a centralized Federal point of contact regarding CAM for the public, CAM practitioners, conventional health care providers, and the media; and facilitating implementation of the Commissions recommendations and actions
13
