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Chelation Therapy and Insurance Fraud

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 states that ACAM had 535 members.

In 1989, an ACAM protocol for "the safe and effective administration of EDTA chelation therapy" was included 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. The initial recommendation is for about 30 such treatments, with the possibility of additional ones later. 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:

• "Chelation therapy is a safe, effective and relatively inexpensive treatment to restore blood flow in victims of atherosclerosis without surgery."
• "EDTA improves calcium and cholesterol metabolism by eliminating metallic catalysts which cause damage to cell membranes by producing oxygen free radicals. Free radical pathology is now believed by many scientists to be an important contributing cause of atherosclerosis, cancer, diabetes and other diseases of aging. EDTA helps to prevent the production of harmful free radicals."
• "Chelation therapy is used to reverse symptoms of hardening of the arteries, also known as atherosclerosis or arteriosclerosis."
• "Every single study of the use of chelation therapy for atherosclerosis which has ever been published, without exception, has described an improvement in blood flow and symptoms."
• "Chelation therapy promotes health by correcting the major underlying cause of arterial blockage. Damaging oxygen free radicals are increased by the presence of metallic elements and act as a chronic irritant to blood vessel walls and cell membranes. EDTA removes those metallic irritants, allowing leaky and damaged cell walls to heal. Plaques smooth over and shrink, allowing more blood to pass. Arterial walls become softer and more pliable, allowing easier expansion. Scientific studies have proven that blood flow increases after chelation therapy."
• "Chelation therapy is an office treatment which improves blood flow throughout the entire vascular system . . .."The reader is advised that varying and even conflicting views are held by other segments of the medical profession. . . . This information represents the current opinion of independent physician consultants to ACAM at the time of publication."

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:

• Preliminary screening
  • Do any claims for the treatment of lead poisoning list chelation or infusion therapy?
  • Do the dates of administration fit a protocol for lead poisoning treatment? Chelation therapy that spans several months should be regarded with great suspicion.
  • Has the doctor ever submitted a chelation therapy for any other claim?
  • Is the doctor an ACAM member or known to do chelation therapy for cardiovascular disease? An ACAM directory can be accessed online. (The complete list can be accessed by searching with a comma in the "Last Name" box.) A list that includes chelationists who have been identified through others sources can be obtained by sending $5 plus a mailing label or self-addressed business-size envelope available to Quackwatch, P.O. Box 1747, Allentown, PA, 18105.
  • Has the patient been previously diagnosed with a cardiovascular problem?
  • Is there an office-visit charge associated with every treatment session?
  • Have charges been made for more than one comprehensive visit during the course of the treatment?
    
• Chart review
  • Is the diagnosis supported by documentation of abnormal blood levels? The accepted diagnostic test for lead exposure is the blood lead level. An erythrocyte protoporphyrin test should also be done.
  • Was the test specimen obtained before the treatment began? It should be.
  • Was the test performed by an out-of-state laboratory?
  • Does the laboratory meet Occupational Safety and Health Administration (OSHA) standards for accuracy requirements in blood lead proficiency testing? A current list of approved laboratories is available online or can be obtained from a regional or area OSHA office.
  • Does the chart document any reported symptoms typical of lead poisoning?
    • Mild toxicity: Occasional abdominal discomfort, mild fatigue, loss of appetite, and metallic taste in mouth.
    • Moderate toxicity: Headache, moderate fatigue, difficulty concentrating, irritability, muscle aches, paresthesia (pins and needles sensations), joint pain, nausea, diffuse abdominal pain, constipation, weight loss, and decreased libido
    • Severe toxicity: Colic (intermittent, severe abdominal cramps), muscle weakness, and mental confusion
  • Do the symptoms fit the reported blood level?
  • Do the blood levels justify doing chelation rather than simply advising the person to avoid further exposure or treating the person with oral medication? In adults, the use of chelation therapy should be reserved for those with significant symptoms or signs of toxicity.
  • Is there a signed consent form that states the nature of the treatment and what it is for?
  • If the alleged cause is exposure in the workplace, has the doctor advised the patient to avoid exposure?
  • If an office visit charge is associated with each treatment session, check whether the chart describes significant contact with the physician.
  • If more than one comprehensive visit is billed, check whether the chart notes justify that level of service.
    
• Additional investigation
  • Is there actual workplace exposure? The jobs and industries that may expose workers to lead include: lead production or smelting; battery manufacturing or recycling; brass, bronze, or lead foundries; radiator repair; scrap-metal handling; lead soldering; firing ranges; ceramics manufacturing; machining or grinding lead alloys; sanding, scraping, burning, or disturbing lead paint; demolition of old structures; and welding or torch-cutting lead paint-coated metal.
  • Has the doctor advised the employer to stop the patient's exposure?
  • If your state has mandatory reporting to a health agency, check whether it has been reported. States belonging to the ABLES program must have a mandatory state requirement that laboratories report blood lead level test results to the state health department or a designee. The lowest blood lead level that must be reported varies from state to state. As of 1999, 28 states were participants.
  • Ask for a list of the ingredients (and doses) the doctor uses for chelation therapy, the name of the manufacturer and supplier, and a copy of the product label. Calcium EDTA is a legitimate chelating agent for lead poisoning. However, if the intravenous solution contains disodium EDTA, DMPS, vitamins, or any other ingredients in the ACAM protocol, you can conclude that the treatment is not appropriate for lead poisoning.
  • Telephone the doctor's office to see what prospective patients are told about chelation therapy, what it costs, and whether it is covered by insurance.
  • If necessary, telephone the patient to ask why the reason treatment was sought. If it was cardiovascular and there is no reason to believe that the patient has lead poisoning, ask the state attorney general and the FBI to investigate.

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

• The Pharmacology of Chelation Therapy (Quackwatch article)
• Staudenger KC, Roth R. Occupational Lead Poisoning. American Family Physician, Feb 15, 1998.
• Lead and Human Health: An Update (American Council on Science and Health)
• Lead Poisoning: Medical Guidelines for the Exposed Worker
  • California Department of Health Services
  • Massachusetts Department of Labor and Workforce Development
• NIOSH: The Adult Blood Lead Epidemiology and Surveillance (ABLES) Program
• Chelation Therapy: Unproven Claims and Unsound Theories (Quackwatch article)
• Questions and Answers about Chelation Therapy (American Heart Association)