I. Regulation of Complementary and Alternative Medicine Products and Providers.
The Federal government regulation of dietary supplements is enforced by the Dietary Supplement Health and Education Act (DSHEA) and through the good manufacturing practices (GMPs). Since the enactment of DSHEA in 1994, manufactures must first notify the FDA of their intent to market a new supplement. They are not required to prove safety and efficacy but must provide information on how they determined evidence exists that it is safe for human consumption. The bottle labeling must not be misleading. The label shall contain the name of product, net quantity, manufacture information, directions for use, facts panel, and inert ingredients (ODS, 2009). The supplement labeling can not claim that it will "diagnose, cure, mitigate, treat or prevent a disease" (ODS, 2009). The labeling may promote a relationship between the product and the reduced risk of a health condition. It may describe the amount of a nutrient contained in the product, or describe how the supplement may affect body organs or systems (ODS, 2009).
The concerns surrounding the quality of supplements was addressed with the development of the GMPs in 2007 (ODS, 2009). The expectation of these regulations is to ensure the manufacturing, storage and quality of the supplements. The manufactures must guarantee the products as to "identity, purity, strength and composition" (ODS, 2009). These regulations, however, do not require the manufactures to develop a standardization processes that would ensure consistency and quality between products.
The regulation of providers is through their respective states by requiring licensure. This provides a process of accountability of these providers to both the government and their patients. Although licensure does not ensure validity of treatments performed by CMA providers, it does allow a level of oversight to their practice.
II. Consumer Spending for Complementary and Alternative Medicine.
The results of a recent government survey estimates that the CAM market totals $33.9 billion or approximately 11 percent of the total out of pocket spending for health care (Nahin, 2009). The study found that 38 percent or 4 out of 10 adults in United States use some form of CAM product or service (NCCAM, 2009). Women with higher levels of education and income exhibited greater use of CAM products and services (Barnes, Bloom, Nahin, 2008). The most commonly reported CMA therapy was the use of biological supplements which totaled $14.8 billion or almost 44 percent of the total expenditures (See Figure 1). The expenditures on these supplements are approximately 33 percent of the out of pocket costs spent on prescriptions drugs (Nahin, 2009).
Figure 3 shows the self-care costs versus practitioner costs and the breakdown of types of self-care costs. Nonvitamin, nonmineral, natural products accounted for the majority of out-of-pocket dollars spent on CAM self-care purchases at $14.8 billion, followed by yoga, tai chi, qi gong classes ($4.1 billion), homeopathic medicine ($2.9 billion) and relaxation techniques ($0.2 billion).
Figure 1: Total CMA out of pocket spending, 2007 (Nahin, 2009)
The amount spent on CAM providers, $11.9 billion, is almost 25 percent of the total out of pocket costs for traditional physician visits (Nahin, 2009). The top providers included: Chiropractic or Osteopathic practitioners totaled $3.9 billion, and Massage practitioners totaled $4.2 billion (Nahin, 2009). The top therapies (deep breathing, meditation, massage, and yoga) have significantly increased over the last five years (Barnes, et al, 2008). The most commonly reported conditions likely to use CAM therapies include: back, neck or joint pain (NCCAM, 2009). The amount of money spent on CAM therapies represents only 1.5 percent of the total health care costs of health care, however they comprise a significant portion of the out of pocket costs for patients.
III. Third-Party Coverage of Complementary and Alternative Medicine.
The growing market of CAM products and services does not justify third party coverage. The increased use of CAM products and services, not generally considered part of the traditional medicine, has placed the insurance companies in the position to indirectly determine their validity. The increased in demand for these products and service should not result in insurance coverage without supportive data.
The process of valid research similar to traditional medicine is lacking with most of the CAM products and services. Many of the beneficial health claims of CAM products and services are limited to patient anecdotal reports. There should not be a separate set of requirements for CAM products and services. The patients' safety should be the priority. The conducting of well designed scientific studies can offer the necessary evidence needed for determining the safety and efficacy of the CAM products and services, thereby considering them for reimbursement.
There can be an increased risk of harm to patients by delaying traditional care in favor of CAM products and services. They may consider the CAM product or service as a more economical or beneficial option, and will delay traditional care necessary for effective treatment. The process of education, training, and licensing of CAM providers would provide a process of accountability for these providers and a starting point for obtaining third party coverage.
Barnes P, Bloom B, and Nahin R. 2008, December. Complementary and Alternative
Medicine Use Among Adults and Children: United States, 2007. CDC National Health Statistics Report #12. Retrieved on February 13, 2010 from NCCAM Website: http://nccam.nih.gov/news/camstats/2007/camsurvey_fs1.htm
Nahin R, Barns P, Stussman B, and Bloom B. 2009, July. Costs of Complementary and Alternative Medicine (CAM) and Frequency of Visits of CAM Practitioners: United States, 2007. CDC National Health Statistics Report #18.
Retrieved on February 13, 2010 from NCCAM Website: http://nccam.nih.gov/news/camstats/costs/costdatafs.htm
National Center for Complementary and Alternative Medicine (NCCAM). 2009, February. Using Dietary Supplements Wisely. Retrieved on February 12, 2010 from NCCAM Website: http://nccam.nih.gov/health/supplements/wiseuse.htm
Office of Dietary Supplements (ODS). 2009, July 7. Dietary Supplements: Background Information. Retrieved on February 13, 2010 from ODS Website: http://ods.od.nih.gov/factsheets/DietarySupplements_pf.asp