|Policy #:||DRUG.00003||Current Effective Date:||07/15/2014|
|Status:||Reviewed||Last Review Date:||05/15/2014|
Chelation therapy uses naturally occurring or chemically designed molecules to reduce potentially dangerous levels of heavy metal ions within the body. Chelation therapy is routinely performed for cases of iron overload, lead poisoning, copper toxicity, and other heavy metal conditions. The use of chelation therapy for non-overload indications continues to be investigated. This document addresses the medical necessity of chelation therapy. This document is not applicable to agents used for the treatment of drug overdose or toxicities.
Note: Please see the following related document for additional information:
The administration of U.S. Food and Drug Administration (FDA) approved chelating agents is considered medically necessary treatment in any of the following conditions:
Investigational and Not Medically Necessary:
Chelation therapy is considered investigational and not medically necessary for the treatment of all other conditions, including but not limited to:
Chelation therapy can be a safe and effective therapy for conditions where heavy metal overload has been accurately diagnosed. The diagnostic workup must consider the individual's history, an appropriate choice of tests and testing methods, and the use of accurate and specific reference values. With specific regard to urine testing, the diagnosis and use of chelation therapy should not be performed based on post-challenge urine testing. In post-challenge, or post-provoked, urine testing, the individual is first given a chelating agent followed by urine testing for heavy metals. The American College of Medical Toxicology (ACMT), in their 2009 position statement on the use of "Post-Chelator Challenge Metal Urine Testing," states that "Scientific investigation to date has failed to establish a valid correlation between prior metal exposure and post-challenge test values" and that post-challenge urine testing is being conducted without needed reference values. The ACMT further states the following:
It is therefore, the position of the American College of Medical Toxicology that post-challenge urinary metal testing has not been scientifically validated, has no demonstrated benefit, and may be harmful when applied in the assessment and treatment of patients in whom there is concern for metal poisoning.
With appropriate heavy metal toxicity diagnosis, several studies published in the peer-reviewed medical literature have established that chelation therapy can be useful in binding toxic metal ions and facilitating their excretion through the liver or kidneys, and mitigating the morbidity associated with heavy metal toxicity such as end organ damage and impaired neurologic functioning.
The role of heavy metal overload in other conditions has not been proven, and thus the role of chelation therapy remains investigational. For example, although chelation therapy has been investigated as a treatment of a wide variety of diseases and conditions, including Alzheimer's disease, Parkinson's, autism spectrum disorders, and rheumatoid arthritis, there has not been adequate scientific evidence to prove the effectiveness and safety of such methods. A meta-analysis by Ng and colleagues (2007) evaluated at chronic mercury exposure in children and adolescents. The report concluded that there was "no evidence to support the association between mercury poisoning and autism" and "there is a lack of data in the literature about the effect of chelation therapy in children with neuro-developmental disabilities." Further study is needed to ascertain the causal role of heavy metal overload in these conditions, followed by studies demonstrating the efficacy of chelation therapy.
Dental amalgams have been investigated as a cause of increased blood levels of mercury potentially associated with chronic fatigue syndrome or Alzheimer's disease. In 2009, the American Dental Association's Council on Scientific Affairs reviewed the scientific literature on amalgam and stated: "the scientific evidence supports the position that amalgam is a valuable, viable and safe choice for dental patients." The Journal of the American Dental Association (ADA) reported that researchers found "no significant association of Alzheimer's Disease with the number, surface area or history of having dental amalgam restorations" and "no statistically significant differences in brain mercury levels between subjects with Alzheimer's disease and control subjects." The ADA's position has been reaffirmed by the U.S. FDA Center for Devices and Radiological Health in 2002, 2006 and 2009. The ADA's 2010 amalgam safety update cites that "studies continue to support the position that dental amalgam is a safe restorative option for both children and adults."
Chelation therapy has been proposed as a treatment of coronary artery disease (CAD), based in part on the hypothesis that chelation could remove atherosclerotic calcium deposits or provide an antioxidant benefit. One small placebo-controlled randomized study of 84 individuals with atherosclerotic heart disease did not report any advantage of chelation therapy, as measured by time to ischemia at 27 weeks of follow up (Anderson, 2003; Knudtson, 2002). The use of chelation therapy in lieu of established therapies, the lack of adequate prior research to verify its safety and effectiveness, and the overall impact of CAD had prompted the National Center for Complementary and Alternative Medicine (NCCAM) and the National Heart, Lung, and Blood Institute (NHLBI) to sponsor a large-scale clinical study. The 5-year Trial to Assess Chelation Therapy (TACT) in CAD began recruiting individuals in March of 2003. This multicenter, randomized, double-blind study enrolled more than 1,600 participants aged 50 or older who had a heart attack. The study tested whether chelation therapy or high-dose vitamin therapy are effective for the treatment of CAD. The primary study endpoint of this trial was a composite of heart attack, stroke, hospitalization for angina, coronary revascularization, and death. The study also evaluated cardiac deaths, nonfatal heart attacks, health-related quality of life (HR-QOL), and cost effectiveness, among other factors. The study has been completed, but study results have not yet been published. Final results of the trial indicate that among stable individuals with a history of heart attack, an intravenous chelation regimen with disodium EDTA, when compared with placebo, modestly reduced the risk of negative cardiovascular outcomes, particularly revascularization procedures. Study authors emphasized that these results are insufficient to support the routine use of chelation therapy for treatment of individuals who have previously suffered from a heart attack (Lamas, 2013).
Chelation therapy involves the administration of drugs that bind heavy metal ions such as lead, arsenic, iron, and mercury in the blood stream preventing their interaction with vital organs, which include the nervous system and kidneys. Such drugs are known as chelating agents. The presence of heavy metals in the blood stream can be the result of several factors including environmental exposure, intake in water and food or in some instances such as lead, inhaling the metal from the air in a location where it is in excess. One frequent cause of lead exposure is through older buildings in which lead based paints were used. There are occupational settings where high levels of metals can occur as well. Additionally, many medical conditions may lead to excess iron in the blood stream that may cause health problems. Chelation therapy reduces the accumulation of essential heavy metals, such as iron and copper or nonessential metals, such as lead and aluminum. Chelators bind with heavy metal ions and enhance the urinary and fecal excretion of these toxic metals.
Chelation therapy has been proposed as a treatment for the removal of heavy metal ions to reduce cellular oxidative damage caused by the production of hydroxyl radicals. This therapy is under investigation for the treatment of numerous non-overload conditions including, but not limited to, cardiovascular disease, reperfusion injury during coronary angioplasty or cardiopulmonary bypass surgery, anthracycline-associated cardiac damage, Alzheimer's disease, Parkinson's disease, autism, PDD, and rheumatoid arthritis.
Chelation agents, however, also have potential toxicity. Chelation agents have been known to bind elements in the body which are necessary for regular functioning, including zinc and calcium. Large doses of vitamins usually accompany the use of chelation agents to lessen these types of side effects. When there is life threatening heavy metal toxicity necessitating treatment with high doses of chelating agents, treatment in the hospital may be needed to monitor for possible side effects. Under less urgent circumstances, chelating agents may be administered on an outpatient basis. Different chelation agents are specific to certain kinds of poisonings.
Primary hemochromatosis: A rare genetic disease that results in the overabundance of iron in the liver, brain, heart and kidneys, causing liver dysfunction, diabetes, changes in skin pigmentation, heart problems, arthritis and testicular atrophy.
Secondary hemochromatosis: A type of hemochromatosis which is usually the result of another condition or disease that causes the overabundance of iron. This disease and condition may include anemias, chronic liver diseases, and the requirement of blood transfusions.
Sickle cell disease: An inherited genetic disorder that causes red blood cells to take on a characteristic crescent or sickle-like shape with decreased ability to carry oxygen.
Sideroblastic anemia: A condition in which there is excess iron in the bone cells.
Thalassemia intermedia: A genetic form of anemia in which there is an abnormality in the oxygen carrying portion of red blood cells.
Wilson's disease: An inherited (autosomal recessive) disorder where excessive quantities of copper build up in the body, particularly in the liver and central nervous system.
The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.
When services are Medically Necessary:
|J0470||Injection, dimercaprol, per 100 mg [BAL in oil]|
|J0600||Injection, edetate calcium disodium up to 1,000 mg|
|J0895||Injection, deferoxamine mesylate, 500 mg [Desferal]|
|J3520||Edetate disodium, per 150 mg|
|M0300||IV chelation therapy|
|S9355||Home infusion therapy, chelation therapy; administrative services, care coordination, and all necessary supplies and equipment, per diem|
|ICD-9 Diagnosis||[For dates of service prior to 10/01/2015]|
|275.01-275.09||Disorders of iron metabolism|
|275.1||Disorders of copper metabolism|
|ICD-10 Diagnosis||[For dates of service on or after 10/01/2015]|
|E83.00-E83.09||Disorders of copper metabolism [includes Wilson's disease]|
|E83.10-E83.19||Disorders of iron metabolism [includes hemochromatosis]|
When services may be Medically Necessary when criteria are met:
For the procedure codes listed above for the following diagnosis codes:
|ICD-9 Diagnosis||[For dates of service prior to 10/01/2015]|
|282.60-282.69||Sickle cell anemia|
|585.6||End stage renal disease (chronic kidney disease requiring chronic dialysis)|
|961.1||Poisoning by arsenical anti-infectives|
|961.2||Poisoning by heavy metal anti-infectives|
|964.0||Poisoning by agents primarily affecting blood constituents; iron and its compounds|
|965.69||Poisoning by other antirheumatics|
|984.0-984.9||Toxic effect of lead and its compounds (including fumes)|
|985.0-985.1||Toxic effect of mercury and its compounds, arsenic and its compounds|
|985.6-985.9||Toxic effect of chromium, other metals|
|V15.86||Contact with and (suspected) exposure to lead|
|V45.11||Renal dialysis status|
|ICD-10 Diagnosis||[For dates of service on or after 10/01/2015]|
|D64.0-D64.3||Sideroblastic anemias (hereditary, secondary, other)|
|N18.6||End stage renal disease|
|T45.4X1S||Poisoning by iron and its compounds, accidental (unintentional); sequela|
|T45.4X2S||Poisoning by iron and its compounds, intentional self-harm; sequela|
|T45.4X3S||Poisoning by iron and its compounds, assault; sequela|
|T45.4X4S||Poisoning by iron and its compounds, undetermined; sequela|
|T45.4X5S||Adverse effect of iron and its compounds, sequela|
|T56.0X1A- T56.0X4S||Toxic effect of lead and its compounds|
|T56.1X1S||Toxic effect of mercury and its compounds, accidental (unintentional); sequela|
|T56.1X2S||Toxic effect of mercury and its compounds, intentional self-harm; sequela|
|T56.1X3S||Toxic effect of mercury and its compounds, assault; sequela|
|T56.1X4S||Toxic effect of mercury and its compounds, undetermined; sequela|
|T56.4X1S||Toxic effect of copper and its compounds, accidental (unintentional); sequela|
|T56.4X2S||Toxic effect of copper and its compounds, intentional self-harm; sequela|
|T56.4X3S||Toxic effect of copper and its compounds, assault; sequela|
|T56.4X4S||Toxic effect of copper and its compounds, undetermined; sequela|
|T56.891S||Toxic effect of other metals, accidental (unintentional); sequela [gold]|
|T56.892S||Toxic effect of other metals, intentional self-harm; sequela [gold]|
|T56.893S||Toxic effect of other metals, assault; sequela [gold]|
|T56.894S||Toxic effect of other metals, undetermined; sequela [gold]|
|T57.0X1S||Toxic effect of arsenic and its compounds, accidental (unintentional); sequela|
|T57.0X2S||Toxic effect of arsenic and its compounds, intentional self-harm; sequela|
|T57.0X3S||Toxic effect of arsenic and its compounds, assault; sequela|
|T57.0X4S||Toxic effect of arsenic and its compounds, undetermined; sequela|
|Z77.010||Contact with and (suspected) exposure to arsenic|
|Z77.011||Contact with and (suspected) exposure to lead|
|Z99.2||Dependence on renal dialysis|
When services are Investigational and Not Medically Necessary:
For the procedure codes listed above for all other diagnoses not listed; or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.
Peer Reviewed Publications:
Government Agency, Medical Society, and Other Authoritative Publications:
|Websites for Additional Information|
Calcium disodium Versenate®
Edathamil calcium disodium
Edetate calcium disodium
Pervasive Development Disorders
Sodium calcium EDTA
The use of specific product names is illustrative 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.
|Reviewed||05/15/2014||Medical Policy & Technology Assessment Committee (MPTAC) review. No change to Position Statement. Updated Rationale, Coding and Reference sections.|
|Revised||05/09/2013||MPTAC review. Removed emergency treatment of hypercalcemia from Position Statement. Updated Coding section and Index.|
|Revised||02/14/2013||MPTAC review. Clarification to Position Statement about urine tests. Addition of autism and PDD to Investigational and Not Medically Necessary Position Statement. Updated Rationale, Background/Overview, References and Index.|
|Reviewed||02/16/2012||MPTAC review. Rationale, References, and Index updated.|
|10/01/2011||Updated Coding section with 10/01/2011 ICD-9 changes.|
|Reviewed||02/17/2011||MPTAC review. Updated Rationale and References.|
|10/01/2010||Updated Coding section with 10/01/2010 ICD-9 changes.|
|Revised||02/25/2010||MPTAC review. Clarification of medical necessity statement from "Patients with hemochromatosis who are not able to tolerate frequent phlebotomy" and "Secondary hemochromatosis due to chronic iron overload due to transfusion-dependent anemias (e.g., thalassemias, Cooley's anemia, sickle cell anemia, sideroblastic anemia)" to read "Individuals with disorders of iron metabolism (e.g., primary or secondary hemochromatosis)". "Copper overload in patients with Wilson's disease, a rare, hereditary condition" clarified to read "Individuals with disorders of copper metabolism (e.g., Wilson's disease)". Updated Background/Overview, Coding, References, Web Sites, Index.|
|Reviewed||05/21/2009||MPTAC review. Updated Rationale, References and Web Sites.|
|Reviewed||05/15/2008||MPTAC review. Updated Rationale, References, and Web Sites.|
|02/21/2008||The phrase "investigational/not medically necessary" was clarified to read "investigational and not medically necessary." This change was approved at the November 29, 2007 MPTAC meeting.|
|Reviewed||05/17/2007||MPTAC review. Clarified Description. Updated Rationale, References, Web Sites and Coding.|
|Reviewed||06/08/2006||MPTAC review. References updated. No change in position.|
|11/18/2005||Added reference for Centers for Medicare and Medicaid Services (CMS) – National Coverage Determination (NCD).|
|Revised||07/14/2005||MPTAC review. Revision based on Pre-merger Anthem and Pre-merger WellPoint Harmonization.|
|Pre-Merger Organizations||Last Review |
|Anthem, Inc.||07/27/2004||DRUG.00003||Chelation Therapy|
|WellPoint Health Networks, Inc.||06/24/2004||8.01.05||Chelation Therapy|