The eagerly anticipated Final Report of the White House Commission on Complementary and Alternative Medicine Policy (WHCCAMP) was released in March 2002, and is now available on the Commission's website <www.whccamp.hhs.gov>.*
Formally received by Secretary of Health and Human Services (HHS) Tommy G. Thompson, the Final Report is currently under review by his agency and others. Various groups representing practitioners, educators, and complementary and alternative medicine (CAM) product manufacturers have distributed position statements and have met with Administration officials and journalists in attempts to shape the eventual White House response.
Key Proposed Actions of the Commission
The WHCCAMP Final Report lists 29 recommendations and 105 actions, organized around the topics of research, education and training, information development and dissemination, access and delivery, and coverage and reimbursement. The most significant recommendations are:
¥ Create a CAM office at the highest level with the Department of Health and Human Services.
¥ Develop research infrastructure at CAM institutions.
¥ Create demonstration projects of residencies and postgraduate training for appropriately educated and trained CAM practitioners.
¥ States should, as appropriate, implement provisions for licensure, registration, and exemption consistent with the practitioners' education, training, and scope of practice.
¥ Develop analytical methods for producing better CAM products.
¥ Increase CAM-conventional collaborative research projects.
¥ Explore expansion of loan programs to students at CAM institutions.
¥ Support federal research on CAM cost-effectiveness and cost-benefit analysis.
¥ Require periodic reports from federal agencies on CAM benefit policy and their inclusion of CAM experts on advisory boards.
Other recommendations of potential interest to the herbal communities include:
¥ Increase U.S. Food and Drug Administration (FDA) resources to fully implement the Dietary Supplement Health and Education Act of 1994 and in particular, finalize Good Manufacturing Practices, and simplify and expand the adverse events reporting system.
¥ Accelerate public and private efforts to develop validation and analytical methods and reference materials.
¥ Create an independent expert panel to develop an objective process for evaluating the safety of dietary supplements. This has been started by the Institute of Medicine's (IOM).
¥ Expand package insert information on dietary supplements, including risks, interactions, and benefits.
¥ Increase financial support to the Federal Trade Commission to identify deceptive advertising practices by dietary supplement manufacturers and develop consumer education programs.
¥ Institute voluntary registration of dietary supplement manufacturers with the FDA to facilitate notification of serious adverse events.
¥ Require manufacturer maintenance of records and reporting of serious adverse events to the FDA.
As stated by Joseph Pizzorno, N.D., a Commission member and long-time naturopathic educator and practitioner, the most significant aspect of the Commission is "that it actually happened."
The release of the Final Report calls on all CAM groups, practitioners, manufacturers, and consumers, to "take themselves and the issues more seriously since now all levels of the culture are paying attention to these issues," Pizzorno said. "If we build on the groundwork laid by the Commission and support implementation of the key recommendations, we can substantially level the playing field of healthcare services."
For the herbal community, the Commission's recommendations require development of clear statements of product quality and lend encouragement to herbal practitioners to develop their own standards of practice and credentialing.
Other recommendations of importance fall in the areas of Research, Education and Training, Information Development and Dissemination, Access and Delivery, and Coverage and Reimbursement. Highlights in these areas are:
The Report calls for significantly more research support for CAM, with emphasis on the following:
¥ Federal research support for practices and products that may be effective, but not profitable to, nor patentable by private investors.
¥ Creation of outreach programs to inform manufacturers about federal research support available to private industry.
¥ Creation of language by state professional regulatory bodies to protect practitioners of CAM engaged in research from sanctions.
¥ Expansion of the Agency for Health Care Research and Quality's Evidence-based Practice Center review of CAM.
Education and Training
The general tenor of the education and training section remained the same as in the Interim Report (released September 18, 2001). The primary shift was the substitution of "feasibility studies" for "demonstration projects" in the areas of loan forgiveness for students and the addition of CAM practitioners to primary care teams. This change may lower the priority of the action, but increases leeway to policymakers in acting on these recommendations. A clear intent is to foster relationships between CAM and conventional education and training programs, with a recommendation to increase the core curriculum of each other's practices and concepts. Federal support, in conjunction with professional organizations, was recommended to develop education and training guidelines. (See education and training recommendations in above "Key Proposed Actions of the Commission.")
Information Development and Dissemination
This section addresses several key concerns that have implications for other areas, especially education, research, and access and delivery. A central recommendation is for the Secretary of HHS to set up a Task Force to identify and eliminate existing CAM information gaps throughout the entire Federal government. More specific actions recommended in this section include:
¥ Relevant federal agencies should create easy-to-understand public information materials on CAM.
¥ Expand the National Library of Medicine and American Library Association training programs for librarians to help consumers access CAM information.
¥ Create a public-private partnership to develop standards for website information on CAM.
¥ Request that States require disclosure of practitioners' level of training, scope of practice, licensure, certification, and disciplinary actions.
Access and Delivery
Access and delivery policy issues are likely to be a central focus of the proposed new federal office on CAM. Recommended actions include:
¥ Provide federal assistance to the States in evaluating the impact of CAM legislation and developing regulation and oversight of CAM services and products.
¥ Identify national healthcare needs, and analyze the relevance of CAM services.
¥ Create a policy advisory committee to address access to CAM practitioners and to foster collaboration among CAM organizations on consensus for standards of practice and education and training.
¥ Assist evaluation by accrediting bodies of conventional healthcare organizations of their CAM policies.
¥ One recommendation and three related actions were proposed to address special and vulnerable populations, including demonstration projects that integrate CAM services into existing delivery models.
Coverage and Reimbursement
Several actions proposed in this section require funding of health services research on CAM cost-effectiveness and cost-benefits. A national coding system for CAM and periodic reports from federal agencies on coverage and reimbursement policy would further support inclusion of CAM in benefit programs. Proposals to encourage federal agencies to develop appropriate clinical criteria for CAM services in their programs and add CAM experts to relevant advisory committees were detailed. Other recommendations include:
¥ Demonstration projects to analyze how CAM may contribute to addressing the 10 leading indicators of health.
¥ Adding CAM practices questions to national surveys.
¥ Public information campaigns on nutrition, exercise, and stress management CAM practices.
¥ Incentives to schools to make healthy snacks and lunches and to eliminate advertising of products such as high-fat snacks and soft drinks.
¥ Evaluate the role of CAM practices and products in workplace wellness and prevention activities and create incentives to develop the resultant programs.
¥ Inclusion of self-care and lifestyle decision-making curriculum in professional CAM and conventional training programs.
The CAM Office
A proposed office to coordinate federal efforts was envisioned as the mechanism to implement the Commission's recommendations and other, emerging issues in CAM. The specifics include:
¥ An office at the highest possible and most appropriate level in the Department of Health and Human Services.
¥ An advisory committee with conventional and CAM experts, and representatives of the public and private sectors.
¥ The office's responsibilities would include coordinating the federal effort in CAM; convening conferences and workshops; acting as the primary point of contact on CAM with the public, practitioners, and the media; and exploring additional topics not covered by the Commission.
Early Effects of the Report
The following major activities were at least partially motivated by release of Final Report of the Commission:
¥ The National Policy Dialogue Report, sponsored by a coalition of CAM groups, was delivered to members of Congress. This report expands and clarifies the central recommendations of the Commission. Since May 2002, various representatives of the Dialogue's sponsoring groups have met with Congressional staff, senators, and representatives to discuss specific initiatives.
¥ Several members of Congress have launched a serious evaluation of CAM issues. The Complementary and Alternative Medicine and Natural Foods Caucus was formed by Senators Tom Harkin (D-IA) and Orrin G. Hatch (R-UT) and Representatives Dan Burton (R-IN) and Dennis Kucinich (D-OH).
¥ Perhaps more significantly, in anticipation of the Commission's report, the Congressional Appropriations Conference Committee Report urged "the Secretary [of HHS] to form a coordinating unit to review the Commission's report and implement ways to better coordinate the Department's many CAM-related activities." The full text of the committee report is available through <www.thomas.loc.gov> under "Status of 2002 Appropriations Bills."
¥ During the life of the WHCCAMP, the IOM acted on a key Commission recommendation to set research priorities by developing its "Proposed Framework for Evaluating the Safety of Dietary Supplements," the goal of which is the establishment of direction in the study of dietary supplements. The 156-page report was released in July 2002, and is open for comments. It is available online only at the National Academy Press website, <www.nap.edu/catalog/10456.html>.
Clearly, the delivery of the Final Report of the White House Commission on CAM Policy represents a historic shift in healthcare policy in this country. The clear thinking and serious deliberation brought to this effort by the Commission staff and members, it is hoped, will inspire the entire CAM community to take up its role in shaping future policy.
Hannah V. Bradford, is a licensed acupuncturist in Bethesda, Maryland and publishes CAM Communications and Reports. Information at: <firstname.lastname@example.org>.
* Within the next few months, the Commission's printed report will be made available to all interested parties. HerbalGram will publish ordering information in HerbalGram 57.