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 individuals 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, deferoxamine 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.
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
Wilson's disease (hepatolenticular degeneration)
Chelation therapy for the treatment of other conditions/diseases including, but not limited to, the following is considered investigational:
Arthritis (including rheumatoid arthritis)
Atherosclerosis (e.g., coronary artery disease or peripheral vascular disease)
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
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.
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.
Agency for Healthcare Research and Quality. (2014). Guide to clinical preventive services, 2014. Retrieved August 16, 2016 from http://www.ahrq.gov/professionals/clinicians-providers/guidelines-recommendations/guide/section3.html.
American Academy of Child and Adolescent Psychiatry. (February, 2014). Practice parameter for the assessment and treatment of children and adolescents with autism spectrum disorder. Retrieved August 16, 2016 from the National Guideline Clearinghouse (NGC: 010489).
American Association for the Study of Liver Diseases. (July, 2011). Diagnosis and management of hemochromatosis: 2011 practice guideline by the American Association for the study of liver diseases. Retrieved August 16, 2016 from the National Guideline Clearinghouse (NGC: 008787).
American College of Cardiology/American Heart Association Task Force on Practice Guidelines, and the American Association for Thoracic Surgery, Preventive Cardiovascular Nurses Association, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons (2014) Focused update of the guideline for the diagnosis and management of patients with stable ischemic heart disease. Journal of the American College of Cardiology, Vol. 64. No. 18, 1929-49.
BlueCross BlueShield Association. Medical Policy Reference Manual. (2:2016). Chelation therapy for off-label uses (8.01.02). Retrieved May 19, 2017 from BlueWeb. (45 articles and/or guidelines reviewed)
Centers for Medicare & Medicaid Services. CMS.gov. NCD for chelation therapy for treatment of atherosclerosis (20.21). Retrieved September 18, 2015 from http://www.cms.gov.
Centers for Medicare & Medicaid Services. CMS.gov. NCD for Ethylenediamine-Tetra-Acetic (EDTA) chelation therapy for treatment of atherosclerosis (20.22). Retrieved August 16, 2016 from http://www.cms.gov.
Escolar, E., Lamas, G., Mark, D., Boineau, R., Goertz, C., Rosenberg, Y., et al. (2014). The effect of an EDTA-based chelation regimen on patients with diabetes mellitus and prior myocardial infarction in the trial to assess chelation therapy (TACT). Circulation, 7 (1), 15-24. (Level 1 evidence)
Lamas, G., & Ergui, I. (2016). Chelation therapy to treat atherosclerosis, particularly in diabetes: is it time to reconsider? Expert Review of Cardiovascular Therapy, 14 (8), 927-938. Abstract retrieved August 16, 2016 from PubMed database.
Lee, C. (2013, November) Federal regulation of unapproved chelation products. Journal of Medical Toxicology, 9:313-317. (Level 5 evidence)
National Heart, Lung and Blood Institute (NHLBI). (2014). Blood transfusion in the management of sickle cell disease. Retrieved August 16, 2016 from the National Guideline Clearinghouse (NGC: 010534).
National Institute for Health and Care Excellence. (2012, June). Autism spectrum disorder in adults: diagnosis and management. Retrieved August 16, 2016 from www.nice.org.uk/guidance.
National Institute for Health and Care Excellence. (2013, August). Autism spectrum disorder in adults in under 19s: support and management. Retrieved May 19, 2017 from www.nice.org.uk/guidance.
Royal College of Obstetricians and Gynaecologists (RCOG). (March, 2014). Management of beta thalassaemia in pregnancy. Retrieved August 16, 2016 from the National Guideline Clearinghouse (NGC: 010322).
Thalassemia International Federation. (2008). Guidelines for the clinical management of thalassaemia. Retrieved October 4, 2011 from http://www.ncbi.nlm.nih.gov/books/NBK173958/.
ORIGINAL EFFECTIVE DATE: 4/1981
MOST RECENT REVIEW DATE: 7/13/2017
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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