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 individuals with iron toxicity, and calcium-ethylenediaminetetraacetic acid (EDTA) is used for individuals 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
Non-transfusion-dependent thalassemia
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 (e.g., coronary artery disease or peripheral vascular disease)
Autism
Diabetes
Multiple sclerosis
IMPORTANT REMINDERS
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 or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
ADDITIONAL INFORMATION
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. A 2022 systematic review included randomized controlled trials and numerous observational trials but did not perform meta-analysis on clinical outcomes. Additional randomized controlled trials reporting health outcomes are needed to establish treatment efficacy.
SOURCES
American Academy of Family Physicians. (2018). Chelation Therapy. Retrieved February 16, 2021 from www.aafp.org.
American Academy of Pediatrics. (2020). Identification, Evaluation, and Management of Children with Autism Spectrum Disorder. Retrieved February 23, 2024 from www.aap.org.
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. Retrieved April 3, 2020 from https://www.acc.org/guidelines/.
Ballas, S.K., Zeidan, A.M., Duong, V.H., DeVeaux, M., & Heeney, M.M. (2018). The effect of iron chelation therapy on overall survival in sickle cell disease and B-thalassemia: A systematic review. American Journal of Hematology, 93 (7), 943-952. (Level 2 evidence)
BlueCross BlueShield Association. Evidence Positioning System. (3:2023). Chelation therapy for off-label uses (8.01.02). Retrieved February 23, 2024 from https://www.bcbsaoca.com/eps/. (42 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. A., Anstrom, K. J., Navas-Acien, A., Boineau, R., Kim, H., Rosenberg, Y., et al. (2022). The trial to assess chelation therapy 2 (TACT2): Rationale and design. American Heart Journal, 252, 1–11. (Level 1 evidence)
National Institute for Health and Care Excellence. (2012, June; last updated June 2021). Autism spectrum disorder in adults: diagnosis and management. Retrieved November 18, 2021 from www.nice.org.uk/guidance.
National Institute for Health and Care Excellence. (2013, August; last updated June 2021). Autism spectrum disorder in under 19s: support and management. Retrieved November 18, 2021 from www.nice.org.uk/guidance.
Ravalli, F., Vela Parada, X., Ujueta, F., Pinotti, R., Anstrom, K. J., & Lamas, G. A., et al. (2022). Chelation therapy in patients with cardiovascular disease: a systematic review. Journal of the American Heart Association, 11 (6), e024648, doi: 10.1161/JAHA.121.024648. (Level 1 evidence)
Villarruz-Sulit, M. V., Forster, R., Dans, A. L., Tan, F. N., & Sulit, D. V. (2020). Chelation therapy for atherosclerotic cardiovascular disease. The Cochrane database of systematic reviews, 5 (5), CD002785. (Level 1 evidence)
ORIGINAL EFFECTIVE DATE: 4/1981
MOST RECENT REVIEW DATE: 3/14/2024
ID_BA
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.
This document has been classified as public information.