Chelation Therapy and Insurance Fraud

Stephen Barrett, M.D.
Robert S. Baratz, M.D., D.D.S., Ph.D.

Chelation therapy is a series of intravenous infusions containing EDTA and various other substances. It is claimed to be effective against kidney and heart disease, arthritis, Parkinson's disease, emphysema, multiple sclerosis, gangrene, psoriasis, and many other serious conditions. However, no well-designed research has shown that chelation therapy can help these conditions and manufacturers of EDTA do not list them as appropriate for EDTA treatment. A course of treatment consisting of 20 to 50 intravenous infusions costs several thousand dollars.

Chelation therapy is heavily promoted as an alternative to coronary bypass surgery. It is sometimes claimed to be a "chemical Roto-Rooter" that can clean out atherosclerotic plaque from the body's arteries. However, there is no evidence that it can do this. The organizations that have criticized chelation claims include the American Heart Association, FDA, the National Institutes of Health, the National Research Council, the California Medical Society, the American Medical Association, U.S.Centers for Disease Control and Prevention, American College of Physicians, the American Academy of Family Physicians, American Society for Clinical Pharmacology Therapeutics, American College of Cardiology, American Osteopathic Association, and Federal Trade Commission (FTC).

Because chelation is not recognized as effective against cardiovascular disease or any of the other conditions listed above, Medicare and most other insurance programs do not cover it for such purposes. To get around this—when submitting insurance claims—some chelationists attempt to disguise what they do.

ACAM's Protocol

The primary organization promoting chelation therapy is the American College for Advancement in Medicine (ACAM), which was founded in 1973 as the American Academy for Medical Preventics. Since its inception, ACAM's focus has been the promotion of chelation therapy. The group conducts courses, sponsors the American Journal of Advancement in Medicine, and administers a "board certification" program that is not recognized by the scientific community. The 1998 edition of Encyclopedia of Medical Organizations and Agencies stated that ACAM had 535 members.

In 1989, an ACAM protocol for "the safe and effective administration of EDTA chelation therapy" was included in a 420-page special issue of the journal. The protocol calls for intravenous infusion of 500 to 1,000 ml of a solution containing 50 mg of disodium EDTA per kilogram of body weight, plus heparin, magnesium chloride, a local anesthetic (to prevent pain at the infusion site), several B-vitamins, and 4 to 20 grams of vitamin C. This solution is infused slowly over 3.5 to 4 hours, one to three times a week. Additional vitamins, minerals, and other substances—prescribed orally—"vary according to preferences of both patients and physicians." Lifestyle modification, which includes stress reduction, caffeine avoidance, alcohol limitation, smoking cessation, exercise, and nutritional counseling, is encouraged as part of the complete therapeutic program. The number of treatments to achieve "optimal therapeutic benefit" for patients with symptomatic disease is said to range from 20 ("minimum"), 30 (usually needed), or 40 ("not uncommon before benefit is reported") to as many as 100 or more over a period of several years. "Full benefit does not normally occur for up to 3 months after a series is completed," the protocol states—and "follow-up treatments may be given once or twice monthly for long-term maintenance, to sustain improvement, and to prevent recurrence of symptoms." The cost, typically $75 to $125 per treatment, is not covered by most insurance plans. Chelation therapy is one of several legitimate methods for treating cases of heavy metal poisoning, but the protocols differ from the ACAM protocol.

In 1997, ACAM issued a revised protocol describing the same procedures but adding circumstances (contraindications) under which chelation should not be performed. As in 1989, the document gives no criteria for determining: (1) who should be treated, (2) how much treatment should be given, or (3) how to tell whether the treatment is working.

FTC Regulatory Action

In 1998, the FTC charged that ACAM's Web site and a brochure had made false or unsubstantiated claims that:

In December 1998, the FTC announced that it had secured a consent agreement barring ACAM from making unsubstantiated advertising claims that chelation therapy is effective against atherosclerosis or any other disease of the circulatory system. The cease-and-desist order is binding only on ACAM itself, not its individual members. Although the FTC could bring action against individual doctors who advertise falsely, it usually leaves that up to the state licensing boards. A few chelation therapists have had their licenses revoked, but most practice without government interference.

Insurance Fraud

Because chelation has legitimate use for treating heavy metal poisoning, some chelation therapists submit fraudulent insurance reports claiming to have treated lead poisoning or another alleged toxic state. Lead poisoning in adults is uncommon and occurs primarily through (a) occupational exposure or (b) repainting an old house that had been painted with lead paint without taking proper precautions. The standard test for lead poisoning is a blood lead level, but some chelation therapists test urine and/or hair. If lead poisoning actually exists, whether discontinuation of exposure is sufficient treatment or chelation therapy should be administered depends on the blood lead concentration, the severity of clinical symptoms, the biochemical and blood abnormalities, and the nature of the exposure. The following questions can help identify deceptive insurance claims:

Some chelation therapists don't mention using chelation therapy but use the procedure code for standard intravenous treatments. Thus it would be wise for insurance companies to set up screening procedures to detect chelation services disguised as "infusion therapy."

If you identify any other ways chelation therapists attempt to mislead insurance companies, please let me know.

For Additional Information

This article was revised on January 24, 2009.

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