DESCRIPTION
Chelation therapy, a treatment for metal toxicity, chemically converts heavy metals into an inert form that can be excreted in the urine. Chelating agents are administered either intravenously or orally and are intended to remove metal ions such as aluminum, arsenic, calcium, copper, iron, lead, mercury, and zinc from the body.
While chelation therapy has been used effectively in patients with heavy metal toxicities, chelation therapy has been proposed for other therapeutic indications, including atherosclerosis, rheumatoid arthritis, Alzheimer’s disease, and autism.
Specific chelating agents are used for particular heavy metal toxicities. For example, desferoxamine is used for patients with iron toxicity, and calcium-ethylenediaminetetraacetic acid (-EDTA)) is used for patients with lead poisoning. Another class of chelating agents, called metal protein attenuating compounds (MPACs), is under investigation for the treatment of Alzheimer’s disease, which is associated with the disequilibrium of cerebral metals. However, no MPACs have received U.S. Food and Drug Administration (FDA) approval for the treatment of Alzheimer’s disease.
POLICY
Chelation therapy for the treatment of the following conditions is considered medically necessary:
Chronic iron overload due to frequent blood transfusion
Control of ventricular arrhythmias or heart block associated with digitalis toxicity
Emergency treatment of hypercalcemia
Extreme conditions of metal toxicity
Lead poisoning
Wilson's disease (hepatolenticular degeneration)
Chelation therapy for the treatment of other conditions/diseases including, but not limited to, the following is considered investigational:
Alzheimer’s disease
Arthritis (including rheumatoid arthritis)
Atherosclerosis (i.e., coronary artery disease or peripheral vascular disease)
Autism
Diabetes
Hypoglycemia
Multiple sclerosis
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
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.
Diseases associated with iron overload due to frequent transfusions include sickle cell anemia and thalassemia.
The National Institute of Mental Health proposed to study the effects of chelation on autism in 2006 but halted the study after an institutional review board concluded that there was no clear evidence of benefit in the chelation trial and that the therapy presented more than a minimal risk.
The use of chelation therapy in the treatment of atherosclerosis has been controversial and considered investigational by 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 October 4, 2011 from http://aappolicy.aappublications.org/cgi/reprint/pediatrics;96/1/155.pdf.
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. (Level 2 Evidence – Independent study)
BlueCross BlueShield Association. Medical Policy Reference Manual. (4:2011). Chelation therapy (8.01.02). Retrieved September 30. 2011 from BlueWeb. (24 articles and/or guidelines reviewed)
Brittenhamm, G. (2011). Iron chelating therapy for transfusional iron overload. New England Journal of Medicine, 364 (2) 146-156.
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]. (2011, August). Chelation therapy for treatment of atherosclerosis (NCD 20.21, p. 2-25). Ingenix.
Complete Guide to Medicare Coverage Issues [Computer software]. (2011, August). Ethylenediamine - tetra - acetic (EDTA) chelation therapy for treatment of atherosclerosis (NCD 20.22, p. 2-25). Ingenix.
Gattermann, N. (2008). Overview of guidelines on iron chelation in patients with myelodysplastic syndromes and transfusional iron – overload. International Journal of Hematology, 2008 (88), 24-29.
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. (Level 1 Evidence - Independent study)
National Lung and Blood Institute. (2002). The management of sickle cell disease. Retrieved October 18, 2011 from http://www.nhlbi.nih.gov/health/prof/blood/sickle/sc_mngt.pdf.
Roberts, E., & Schilsky, M., (2003). A practice guideline on Wilson disease. Hepatology, 37 (6) 1475-1492.
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 October 4, 2011 from http://health.state.tn.us/Downloads/g4015060.pdf.
Thalassaemia International Federation. (2008). Guidelines for the clinical management of Thalassaemia. Retrieved October 18, 2011 from United Kingdom Forum on Haemoglobin. (2008). Consensus view on choice of iron chelation therapy in transfusional iron overload for inherited anaemias. Retrieved October 4, 2011 from http://www.haemoglobin.org.uk/pdf/guidelines/Consensus_oral_chelation_v7.pdf.
Vichinsky, E., Bernaudin, F., Forni, G., Gardner, R., Hassell, K., Heeney, M., et al. (2011) Long term safety and efficacy of deferasirox (Exjade®) for up to 5 years in transfusional iron - overloaded patients with sickle cell disease. British Journal of Haematology, 154 (3), 387-397. (Level 1 Evidence - Industry supported)
ORIGINAL EFFECTIVE DATE: 4/1981
MOST RECENT REVIEW DATE: 2/12/2012
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Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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