DESCRIPTION
Chelation therapy consists of the intravenous or oral administration of chelating agents (e.g., disodium edetate, Endrate, EDTA), which remove metal ions from the body, such as lead, zinc, iron, copper, and calcium.
POLICY
Chelation therapy for the treatment of the following conditions is considered medically necessary:
Control of ventricular arrhythmias or heart block associated with digitalis toxicity
Emergency treatment of hypercalcemia
Extreme conditions of metal toxicity, including thalassemia with hemosiderosis
Wilson's disease (hepatolenticular degeneration)
Lead poisoning
Chelation therapy for the treatment of other conditions/diseases including, but not limited to, the following is considered investigational:
Atherosclerosis (i.e., coronary artery disease or peripheral vascular disease)
Multiple sclerosis
Arthritis
Hypoglycemia
Diabetes
ADDITIONAL INFORMATION
The American Academy of Pediatrics (AAP) recommends the following chelation therapy treatment guidelines for lead exposure in children:
Less than 25 µg/dL: Treatment with chelation is not indicated.
25 µg/dL to 45 µg/dL: Aggressive environmental intervention is indicated. However, since no evidence exists that chelation avoids or ameliorates neurotoxicity; chelator should not be routinely administered. Should blood levels persist in this range despite environmental abatement, chelation may benefit some patients.
45 µg/dL to 70 µg/dL: Chelation is indicated. In the absence of encephalopathy, the AAP guideline contains additional recommendations regarding the types of chelating agents to be administered and appropriate dosages.
Greater than 70 µg/dL or encephalopathy: Inpatient chelation therapy is indicated. The AAP guideline contains additional recommendations regarding the types of chelating agents to be administered and appropriate dosages.
No controlled studies were found in published literature that validates the use of chelation therapy for the treatment of other conditions/diseases.
The use of Chelation Therapy in the treatment of atherosclerosis has been controversial and considered investigational by most cardiology related professional organizations. Two small randomized trials have also reported no benefit of chelation therapy as a treatment of peripheral arterial disease. Other published studies consist primarily of case reports and case series. No articles were identified that focused on the use of chelation therapy for multiple sclerosis, arthritis, hypoglycemia, or diabetes.
SOURCES
American Academy of Pediatrics. (1995). Treatment guidelines for lead exposure in children (RE9529). Retrieved January 13, 2009 from http://aappolicy.aappublications.org/cgi/reprint/pediatrics;96/1/155.pdf.
American Heart Association. Chelation therapy: AHA recommendation. Retrieved January 13, 2009 from http://www.americanheart.org/presenter.jhtml?identifier=4493.
Anderson, T. J., Hubacek, J., Wyse, D. G., & Knudtson, M. L. (2003). Effect of chelation therapy on endothelial function in patients with coronary artery disease: PATCH substudy. Journal of the American College of Cardiology, 41 (3), 420-425.
BlueCross BlueShield Association. Medical Policy Reference Manual. (3:2002). Chelation therapy (8.01.02). Retrieved January 12, 2009 from BlueWeb.
Chappell, L. T., & Stahl, J. P. (1993). The correlation between chelation therapy and improvement in cardiovascular function: a meta-analysis. Journal of Advancement in Medicine, 6 (3), 139-158.
Complete Guide to Medicare Coverage Issues [Computer software]. (2008, November). Chelation therapy for treatment of atherosclerosis (NCD 20.21, p. 2-25). The Ingenix Complete Guide to Medicare Coverage Issues.
Complete Guide to Medicare Coverage Issues [Computer software]. (2008, November). Ethylenediamine - tetra - acetic (EDTA) chelation therapy for treatment of atherosclerosis (NCD 20.22, p. 2-25). The Ingenix Complete Guide to Medicare Coverage Issues.
Federal Trade Commission. (1998, December) Medical association settles false advertising charges over promotion of "chelation therapy". Retrieved January 13, 2009 from http://www.ftc.gov/opa/1998/12/acam.htm.
Ford, M. D. Delaney, K. A., Ling, L. J., & Erickson, T. (Eds.). (2001). Clinical Toxicology (1st ed., pp. 47, 732, & 741). Philadelphia: W. B. Saunders Company.
Knudtson, M. L., Wyse, D. G., Galbraith, P. D., Brant, R., Hildebrand, K., Paterson, D., et al. (2002). Chelation therapy for ischemic heart disease: a randomized controlled trial. JAMA, 287 (4), 481-486.
National Guideline Clearinghouse. (2002, March). Managing elevated blood lead levels among young children: Recommendations from the advisory committee on childhood lead poisoning prevention. Retrieved January 25, 2006 from National Guideline Clearinghouse database.
National Guideline Clearinghouse. (2003, June). A practice guideline on Wilson disease. Retrieved January 25, 2006 from National Guideline Clearinghouse database.
QuackWatch. (2003, March). Chelation therapy: Unproven claims and unsound theories. Retrieved January 13, 2009 from http://www.quackwatch.org/01QuackeryRelatedTopics/chelation.html.
QuackWatch. (2005, March). Position Statement: Tennessee Board of Medical Examiners. Alternative medicine or procedures without evidence of scientifically proven benefit. Retrieved January 13, 2009 from http://www.chelationwatch.org/reg/tn.shtml.
Roberts DJ, Rees D, Howard J, Hyde C, Brunskill S. Desferrioxamine mesylate for managing transfusional iron overload in people with transfusion-dependent thalassaemia. The Cochrane Database of Systematic Reviews 2005, Issue 4. Art. No.: CD004450. DOI: 10.1002/14651858.CD004450.pub2.
Tennessee Code: Title 63 Professions of the Healing Arts: Chapter 6 Medicine and Surgery: Part 2 General Provisions: 63-6-214. Grounds for license denial, suspension or revocation - Reporting misconduct. Retrieved January 13, 2009 from http://www.michie.com/tennessee/lpext.dll?f=templates&fn=main-h.htm&cp=tncode.
Villarruz, MV, Dans, A, Tan F. Chelation therapy for atherosclerotic cardiovascular disease (Cochrane Review). In: The Cochrane Library, Issue 4, 2002. Oxford: Update Software.
ORIGINAL EFFECTIVE DATE: 4/1981
MOST RECENT REVIEW DATE: 2/12/2009
ID_BT
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