BlueCross BlueShield of Tennessee Medical Policy Manual

Chelation Therapy

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 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.

POLICY

IMPORTANT REMINDERS

ADDITIONAL INFORMATION  

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 

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

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