Complementary/alternative medicine has a substantial presence in the United States health care system. Both public and professional interest in these therapies is increasing. The College of Physicians and Surgeons at Columbia University and the Falk Institute of Pittsburgh University have research projects devoted to assigning an integrative role in the health care system to complementary/alternative therapies.
In 1991, Congress established the Office of Alternative Medicine within the National Institutes of Health to encourage scientific research in the field. The National Institutes of Health Revitalization Act of June 1993 (140) was a landmark. It expanded the Office of Alternative Medicine within the National Institutes of Health from a staff of six to a staff of 12. The Office's objectives include the facilitation and evaluation of "alternative medical treatment modalities, including acupuncture and Oriental medicine, homeopathic medicine, and physical manipulative therapies". The Office is mandated to set up an advisory council, establish an information clearinghouse to exchange information on traditional medicine, support research and training, and provide biennial reports on the Office's activities to the Director of the National Institutes of Health. These reports are then included in biennial reports to the President and Congress.
A 1997 national survey (141) estimated that in the previous year 42.1% of the adult population in the United States had used at least one of the complementary/alternative therapies included in the survey. This is an increase from 33.8% in 1990. The therapies included in the survey were relaxation techniques, herbal medicines, massage, chiropractic, spiritual healing by others, megavitamins, self-help groups, imagery, commercial diets, folk remedies, lifestyle diets, energy healing, homeopathy, hypnosis, biofeedback, and acupuncture. Rates of use of complementary/alternative therapies in 1997 ranged from 32% to 54% in the socio-demographic groups examined. The therapies with the greatest increases in use included herbal medicines, massage, megavitamins, self-help groups, folk remedies, energy healing, and homeopathy. Visits to chiropractors and massage therapists accounted for nearly half of all visits to complementary/alternative medical practitioners in 1997.
The probability of patients visiting a complementary/alternative medical practitioner increased from 36.3% to 46.3% between 1990 and 1997. The total number of visits to complementary/alternative medicine practitioners increased from 427 million in 1990 to 629 million in 1997, thereby exceeding total visits to all primary care allopathic physicians.
Estimated expenditures for professional complementary/alternative medical services increased 45.2% between 1990 and 1997. For 1997, these expenditures are conservatively estimated at $21.2 billion with at least $12.2 billion of this paid out-of-pocket. Total 1997 out-of-pocket expenditures relating to complementary/alternative therapies are conservatively estimated at $27 billion, which is comparable with the projected 1997 out-of-pocket expenditures for all physician services. Just over half of patients (64% in 1990 and 58.3% in 1997) of complementary/alternative medical practitioners pay entirely out-of-pocket for the services.
Approximately 3000 allopathic physicians and other health care practitioners currently use homeopathy (142).
In 1993, more than 45 000 licensed chiropractors and 32 000 Doctors of Osteopathy were practising in the United States. More than 60% of osteopathic physicians are involved in primary care. The profession is responsible for approximately 10% of the total health care delivered in the United States. Chiropractors currently see 10% to 15% of the population of the United States (143). There are about 6000 acupuncture practitioners in the United States. An estimated 3000 allopathic physicians have taken courses in acupuncture with the intention of incorporating it into their medical practices (143). There are over 1000 licensed naturopathic doctors in the United States. There are approximately 50 000 biofield practitioners providing 18 million sessions annually. There are approximately 50 000 qualified massage therapists in the United States, providing 45 million one-hour massage sessions per year. There are 10 ayurvedic clinics in North America, including one hospital-based clinic that served 25 000 patients between 1985 and 1994 (143).
In the United States, regulatory controls surrounding complementary/alternative medicine involve six related areas of law: licensing, scope of practice, malpractice, professional discipline, third-party reimbursement, and access to treatments. State laws dominate the first five areas. Federal laws, particularly food and drug laws, largely control the sixth. In each of these areas, legal rules aim to safeguard consumers against fraud and to ensure patient protection against dangerous practices and practitioners. Because allopathic medicine has historically dominated licensing, accreditation, reimbursement, and other regulatory structures, however, existing legal rules governing complementary/alternative therapies and providers arguably favour allopathic medicine and paternalism at the expense of concerns for patient choice and autonomy.
Licensing laws in each state provide that the unlicensed practice of medicine is a crime, with medicine being broadly defined to include such matters as diagnosis and treatment of disease or any human condition. Both non-licensed providers of complementary/alternative care (such as non-allopathic physician homeopaths, herbalists, iridologists, nutritionists, and spiritualists not practising within the tenets of a specific recognized religion) and licensed complementary/alternative care providers (such as chiropractors and, in many states, acupuncturists, massage therapists, and naturopaths) who exceed their legislatively authorized scope of practice risk prosecution for unlicensed medical practice.
Under malpractice rules, practitioners are liable when their professional practices deviate from standards of care applicable to their locale and speciality and when patient injury results. This is problematic since complementary/alternative care by definition deviates from allopathic standards of care. Professional disciplinary cases are frequently brought against allopathic providers integrating complementary/alternative practices, often in tandem with civil malpractice lawsuits. Third-party reimbursement is regularly denied to patients receiving such treatments because the third parties consider the treatments to be experimental and/or not medically necessary. Patients find access to complementary/alternative treatments restricted further on the grounds that the medicinal substances used to diagnose, cure, or mitigate disease are classified under federal law as new drugs and are thus subject to extensive premarketing approval to show safety and efficacy before they may be used.
Although more and more complementary/alternative medical providers are being licensed in the United States, legal rules must continue to evolve to accommodate widespread consumer and provider use of therapies that have historically fallen outside the scope of allopathic medicine (144).
Traditional Native North American medicine
Traditional Native North American medicine in the United States is regulated under the Self-Determination Act (82).
Arizona, Connecticut, and Nevada have specific licensing boards for homeopathic physicians.
The market for homeopathic medicine in the United States is a multi-million dollar industry. Homeopathic remedies are recognized and regulated by the Food and Drug Administration and are manufactured by pharmaceutical companies under strict guidelines.
Statutes regulating the practice of manipulative therapy exist in every state of the United States (145). Practice is restricted to persons who fulfil certain requirements and have been registered and/or licensed. In many cases, practising without a licence is an offence.
Licensing legislation regulates chiropractic educational standards (81). An example of such legislation is found in Sections 6551-6556 of Book 16 of the Consolidated Laws of New York (146, 147). The New York statute states that chiropractors may not treat specified diseases; perform operations; reduce fractures or dislocations; or prescribe, administer, dispense, or otherwise use medicines or medicaments in their practice. Only licensed persons may practice chiropractic and use the title of "Chiropractor". To be eligible for a professional licence, an applicant must have completed two years of pre-professional college study and a four-year chiropractic resident programme as well as obtaining satisfactory experience and passing the licensing examinations.
In the United States, practitioners of manipulative therapy are sometimes considered on the same professional level as allopathic physicians. Part 59 of Title 57 of the United States Code of Federal Regulations (148) includes osteopathic general practice in the definition of allopathic family medicine. However, with the exceptions of South Carolina and Arizona, all states require chiropractors to add an accompanying qualifying reference to chiropractic following the use of the title "Doctor" or "Physician" (149).
Section 355 of the Federal Food, Drug, and Cosmetic Act (150) covers the labelling of medicines and devices, including acupuncture needles and equipment. In 1973, acupuncture was declared by the Food and Drug Administration to be a method of treatment for investigational use by licensed practitioners only until "substantial scientific evidence is obtained by valid research studies supporting the safety and therapeutic usefulness of acupuncture devices". The Food and Drug Administration at that time published a notice calling for labelling requirements for such devices, including the following warning: "Caution: experimental device limited to investigational use by or under the direct supervision of a medical or dental practitioner."
States have an array of provisions regarding the practice of acupuncture. In New York, legislation (151) was passed in 1974 on the recommendation of the State Commission on Acupuncture. The legislation allowed state boards responsible for medicine and dentistry to formulate rules and regulations governing the provision of acupuncture and to establish licensing procedures for its practice in New York. The main prerequisites for a licence were that the applicant had practised acupuncture for at least 10 years and had a licence as "a doctor of acupuncture, herb physician, or doctor of traditional Chinese medicine duly issued by the licensing board of any foreign country".
A 1991 statute (146) altered the above position by substituting licensing rules; creating a board of acupuncture made up of acupuncturists, licensed allopathic physicians, and members of the public; and obliging licensed acupuncturists to advise patients about the importance of consulting a licensed allopathic physician concerning their prognosis, and keep a record of the dispensation of this advice.
To qualify for a licence to practice acupuncture, applicants must satisfy a pre-professional education requirement of at least 60 hours in an approved university or college, including a minimum of nine hours in the biosciences. They must then complete a professional programme, lasting a minimum of 450 hours, which involves classroom instruction in the biosciences and acupuncture and supervised clinical acupuncture experience. Applicants must pass a licensing exam set by the National Commission for the Certification of Acupuncturists or other approved body. Finally, applicants must be at least 21 years of age. Section 8216 permits the enactment of rules for the certification of allopathic physicians and dentists as acupuncturists. Limited permits for applicants who meet the requirements for admission to the licensing exam can be issued. However, practice under a limited permit must be under the supervision of a licensed acupuncturist.
During the 1970s, the legislatures of several other states established conditions for the licensing of acupuncturists who were not allopathic physicians. As of 1981, non-allopathic physicians have been permitted to practise acupuncture under various conditions in at least 15 states (152).
Under a 1978 act in Rhode Island (153):
[No treatment by acupuncture] shall be performed unless within a period of 12 months preceding the treatment the patient shall have undergone a diagnostic examination by a duly licensed and registered physician with regard to his illness or malady. The doctor of acupuncture [as defined in the act] or the licensed acupuncture assistant [likewise defined] shall first... be familiar with the results of the said diagnostic examination.
The act provides for the establishment of the State Board of Acupuncture and also defines the conditions under which the Board may issue licences to practise acupuncture or to perform as an acupuncture assistant. The conditions for the issue of a licence in Rhode Island are as follows: the applicant must have successfully completed a course of study of 36 months in acupuncture at a college in the Hong Kong Special Administrative Region of China or have qualifications considered equivalent by the State Board of Acupuncture, the applicant must have practised acupuncture for 10 years, and the applicant must have passed examinations set by the Board.
In Florida (154), only persons certified by the Department of Professional Regulation may practise acupuncture. Some of the conditions for certification are that the applicant must be at least 18 years of age, have undertaken two years of education in acupuncture at a school or college approved by the Department (experience may be substituted for a part of this training), and pass an examination. It is a misdemeanour to practise acupuncture without a valid certificate in Florida.
California's Business and Professions Code (155) lays down an extensive set of provisions regulating the acupuncture profession. California has appointed an Acupuncture Board, which consists of nine members. By law, four of these members must be acupuncturists with at least five years of experience who are not also allopathic surgeons or physicians, one must be an allopathic physician or surgeon with two years of experience in acupuncture, the remaining four must be members of the public who are neither acupuncturists nor allopathic physicians or surgeons.
In California, in order to receive a licence to practise, applicants must be at least 18 years of age, have completed an approved course in acupuncture or a tutorial programme in the practice of acupuncture, passed an examination administered by the appropriate Board, and completed a clinical internship programme of up to nine months. The length of the internship depends on the applicant's examination results and prior clinical training. Internship requirements are waived for applicants who have previously completed 800 hours of clinical training. Practising acupuncture without a licence is a misdemeanour. A previous requirement that acupuncture treatments cannot be performed on a patient without a prior diagnosis or referral from a licensed physician, surgeon, dentist, podiatrist, or chiropractor has been removed from the legislation. The completion of 30 hours of continuing education every two years is required for renewal of the annual practising licence.
Naturopathy remains relatively marginalized in the United States. Few states license naturopaths (156). Although legislation on naturopathy varies between states, a number of general regulations do exist. Under state licensing procedures, naturopaths have a limited range of treatment options. The use of electricity, heat, water, vibration, and muscular articulation are permitted as therapeutic modalities, but the general practice of medicine and surgery are prohibited. The administration of toxic drugs is similarly prohibited (145).
Treatment involving the use of hypnosis is characterized as the practice of medicine and surgery and is therefore subject to licensing requirements.
No state has licensing requirements for biofield practitioners. Since legal constraints in many states restrict the use of the terms "patient" and "treatment", most biofield practitioners use the terms "receiver" and "session" in describing their work.
Education and training
The majority of allopathic medical schools in the United States now offer courses on complementary/alternative medicine (141). Beginning in 1997, primary care allopathic physicians have been able to take courses designed to introduce them to homeopathy and to encourage them to incorporate homeopathy in their practices (53).
The United States has the largest number of chiropractic colleges of any country. Sixteen colleges are recognized by the World Federation of Chiropractic and accredited by the Council on Chiropractic Education, the United States accrediting agency for the chiropractic profession. The Council on Chiropractic Education establishes minimum standards and assesses institutional compliance with these standards as well as overall effectiveness (81).
With only a few states licensing naturopaths (156), all except two naturopathic colleges have closed. Entry to these colleges is conditional on two years of pre-professional coursework. The programmes are four years in length.
Complementary/alternative therapies are infrequently included in benefit packages, although the number of insurers and managed care organizations offering coverage is increasing (141). When complementary/alternative therapies are covered, they tend to have high deductibles and co-payments that are subject to stringent limits on the number of visits or total dollar coverage.
Chiropractic care is the exception (116). In many states, chiropractic is covered in full or in part by Medicaid, Medicare, and other Social Security programmes as well as private health insurance. The cost of chiropractic treatment can also be reclaimed under workers' compensation legislation designed to reimburse, at least in part, medical expenses incurred by injured workers.