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, chelators 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 validate the use of chelation therapy for the treatment of other conditions/diseases.
Chelation therapy for the treatment of other conditions/diseases including those addressed in the medical policy as investigational does not meet the following technology evaluation criteria:
The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes.
The technology must improve the net health outcome.
The technology must be as beneficial as any established alternatives.
The improvement must be attainable outside the investigational settings.
SOURCES
American Academy of Pediatrics. (1995). Treatment guidelines for lead exposure in children (RE9529). Retrieved May 20, 2003 from http://aappolicy.aappublications.org/cgi/reprint/pediatrics;96/1/155.pdf.
American College of Cardiology. (1990). Position Statement. Chelation therapy. Retrieved May 20, 2003 from http://www.acc.org/clinical/position/72540.pdf.
American Heart Association. Chelation therapy: AHA recommendation. Retrieved January 25, 2006 from http://www.americanheart.org/presenter.jhtml?identifier=4493.
American Medical Association. (2006). H-175.994 Chelation Therapy. Retrieved January 25, 2006 from http://www.ama-assn.org/apps/pf_new/pf_online?f_n=browse&doc=policyfiles/HnE/H-175.994.HTM.
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. Abstract retrieved May 19, 2003 from PubMed database.
BlueCross BlueShield Association. Medical Policy Reference Manual. (3:2002). Chelation therapy (8.01.02). Retrieved January 24, 2006 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]. (2005, November). Chelation therapy for treatment of atherosclerosis (NCD 20.21, p. 2-25). St. Anthony Publishing.
Complete Guide to Medicare Coverage Issues [Computer software]. (2005, November). Ethylenediamine - tetra - acetic (EDTA) chelation therapy for treatment of atherosclerosis (NCD 20.22, p. 2-25). St. Anthony Publishing.
Ernst, E. (1997). Chelation therapy for peripheral arterial occlusive disease: a systematic review. Circulation, 96 (3), 1031-1033. Abstract retrieved November 11, 2002 from The Cochrane Library database.
Ernst, E. (2000). Chelation therapy for coronary heart disease: an overview of all clinical investigations. American Heart Journal, 140 (1), 139-141. Abstract retrieved November 19, 2002 from The Cochrane Library database.
Federal Trade Commission. (1998, December) Medical association settles false advertising charges over promotion of "chelation therapy". Retrieved February 17, 2003 from http://www.ftc.gov/opa/1998/12/acam.htm.
Ford, M. D. Delaney, K. A., Ling, L. J., & Erickson, T. (Eds.), Clinical Toxicology (1st ed., pp. 47, 732, & 741). Philadelphia: W. B. Saunders Company.
Goyer, R. A., Cherain, M. G., Jones, M. M. & Reigart, J. R. (1995). Role of chelating agents for prevention, intervention, and treatment of exposures to toxic metals. Environmental Health Perspectives, 103 (11). Retrieved April 13, 2000 from http://ehpnet1.niehs.nih.gov/docs/1995/103-11/meetingreport/html.
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 24, 2006 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 24, 2006 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.pub2. 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 26, 2006 from http://198.187.128.12/tennessee/lpext.dll/Infobase/39cef/3a328/3a3b2/3a469.
Villarruz, MV, Dans, A, Tan F. Chelation therapy for atherosclerotic cardiovascular disease (Cochrane Review). In: The Cochrane Library, Issue 4, 2002. Oxford: Update Software.
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EFFECTIVE DATE |
4/13/2006 |
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