Medical policy: Intravenous Chelation Therapy

Número de política: MP 4.005

Fecha de entrada en vigor: 2/1/2026

Política

Dimercaprol (BAL in oil) may be considered medically necessary for one of the following indications:

• Treatment of arsenic, gold, or mercury toxicity
• Acute lead poisoning when used concomitantly with edetate calcium disodium injection
• Acute poisoning by mercury salts if therapy begins within one‑ or two‑hours following ingestion

All other indications are considered investigational. There is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with this procedure for these indications.

Edetate calcium disodium (calcium EDTA) may be considered medically necessary for the following:

• Reduction of blood levels and depot stores of lead in lead poisoning (acute and chronic) and lead encephalopathy

All other indications are considered investigational. There is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with this procedure for these indications.

Deferoxamine mesylate (Desferal®) may be considered medically necessary for one of the following indications:

• Acute iron toxicity
• Chronic iron toxicity due to transfusion‑dependent anemias

All other indications are considered investigational. There is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with this procedure for these indications.

The FDA removed the approval for NaEDTA as chelation therapy due to safety concerns. Its use is considered investigational.

Off‑label applications of chelation therapy are considered investigational, including, but not limited to:

• Atherosclerosis/arteriosclerosis (e.g., coronary artery disease, secondary prevention in patients with myocardial infarction, or peripheral vascular disease)
• Multiple sclerosis
• Arthritis (including rheumatoid arthritis)
• Autism spectrum disorders
• Alzheimer’s disease
• Diabetes

There is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with this procedure for these indications.

Directrices de la política

Due to pharmacological property differences and mechanisms of action, each chelation agent should only be used as indicated in accordance with the FDA label.

For the below 2 bullet points, most patients should be treated with other modalities. Digitalis toxicity is currently treated in most patients with Fab monoclonal antibodies. The FDA removed the approval for NaEDTA as chelation therapy due to safety concerns and recommended that other chelators be used:

• Control ventricular arrhythmias or heart block associated with digitalis toxicity
• Emergency treatment of hypercalcemia

Suggested toxic or normal levels of select heavy metals are listed in Table 1.

Suggested toxic or normal concentrations of heavy metals (Table 1)

Adapted from Adal (2018). CDC: Centers for Disease Control and Prevention.

A hair analysis is useful to assess mercury exposure in epidemiologic studies. However, hair analysis in individual patients must be interpreted with consideration of the patient's history, signs, and symptoms, and possible alternative explanations. Measurement of blood and urine mercury levels can exclude exogenous contamination; therefore, blood or urine mercury levels may be more robust measures of exposure in individual patients.

Cross-references:

• MP 2.304 Autism Spectrum Disorders
• MP 2.312 Genetic Testing for Hereditary Hemochromatosis

Variaciones del producto

Esta política solo se aplica a ciertos programas y productos administrados por Capital Blue Cross y está sujeta a variaciones en los beneficios. Consulte la información adicional a continuación.

FEP PPO - Consulte el Manual de Políticas Médicas de FEP.

Descripción/Antecedentes

Chelation therapy is an established treatment for the removal of metal toxins by converting them to a chemically inert form that can be excreted in the urine. Chelation therapy comprises intravenous or oral administration of chelating agents that remove metal ions such as lead, aluminum, mercury, arsenic, zinc, iron, copper, and calcium from the body. Specific chelating agents are used for particular heavy metal toxicities. For example, desferrioxamine (not FDA-approved) is used for patients with iron toxicity, and calcium-ethylenediaminetetraacetic acid (EDTA) is used for patients with lead poisoning. Disodium-EDTA is not recommended for acute lead poisoning due to the increased risk of death from hypocalcemia.

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 disequilibrium of cerebral metals. Unlike traditional systemic chelators that bind and remove metals from tissues systemically, MPACs have subtle effects on metal homeostasis and abnormal metal interactions. In animal models of Alzheimer's disease, they promote the solubilization and clearance of beta amyloid by binding its metal-ion complex and also inhibit redox reactions that generate neurotoxic free radicals. MPACs therefore interrupt two putative pathogenic processes of Alzheimer's disease. However, no MPACs have received FDA approval for the treatment of Alzheimer's disease.

Chelation therapy also has been discussed as a treatment for other indications including atherosclerosis and autism. For example, EDTA chelation therapy has been proposed in patients with atherosclerosis as a method of decreasing obstruction in the arteries.

Regulatory status

In 1953, EDTA (Versenate) was approved by the U.S. Food and Drug Administration (FDA) for lowering blood lead levels among both pediatric and adult patients with lead poisoning. In 1991, succimer (Chemet) was approved by the FDA for the treatment of lead poisoning in pediatric patients only. The FDA approved disodium-EDTA for use in selected patients with hypercalcemia and for use in patients with heart rhythm problems due to intoxication with digitalis.

In 2008, the FDA withdrew approval of disodium-EDTA due to safety concerns and recommended that other forms of chelation therapy be used.

Several iron chelating agents are FDA-approved:

• In 1968, deferoxamine (Desferal; Novartis) was approved by FDA for subcutaneous, intramuscular, or intravenous injections to treat acute iron intoxication and chronic iron overload due to transfusion-dependent anemia. Several generic forms of deferoxamine have been approved by FDA.
• In 2005, deferasirox (Exjade; Novartis) was approved by FDA, is available as a tablet for oral suspension, and is indicated for the treatment of chronic iron overload due to blood transfusions in patients ages 2 years and older. Under the accelerated approval program, FDA expanded the indications for deferasirox in 2013 to include treatment of patients age 10 years and older with chronic iron overload due to non-transfusion-dependent thalassemia syndromes and specific liver iron concentration and serum ferritin levels. A generic version of deferasirox tablet for oral suspension has also been approved by FDA. In 2015, an oral tablet formulation for deferasirox (Jadenu™) was approved by FDA. All formulations of deferasirox carry a black box warning because it may cause serious and fatal renal toxicity and failure, hepatic toxicity and failure, and gastrointestinal hemorrhage. As a result, treatment with deferasirox requires close patient monitoring, including laboratory tests of renal and hepatic function.
• In 2011, the iron chelator deferiprone (Ferriprox®) was approved by FDA for treatment of patients with transfusional overload due to thalassemia syndromes when another chelation therapy is inadequate. Deferiprone is available in tablet and oral solution. Ferriprox® carries a black box warning because it can cause agranulocytosis that can lead to serious infections and death. As a result, absolute neutrophil count should be monitored before and during treatment.

In a June 2014 warning to consumers, the FDA advised that FDA-approved chelating agents would be available by prescription only. There are no FDA-approved over-the-counter chelation products.

Fundamento

Summary of evidence

For individuals who have Alzheimer disease, or cardiovascular disease, or autism spectrum disorder, or diabetes, or multiple sclerosis, or arthritis who receive chelation therapy, the evidence includes a small number of randomized controlled trials and case series. Relevant outcomes are symptoms, change in disease status, morbid events, functional outcomes, health status measures, quality of life, and treatment-related morbidity. One randomized controlled trial (the Trial to Assess Chelation Therapy) reported that chelation therapy reduced cardiovascular events in patients with previous myocardial infarction and that the benefit was greater in diabetic patients compared with nondiabetic patients. However, this trial had significant limitations (e.g., high dropout rates) and, therefore, conclusions are not definitive.

For other conditions, the available randomized controlled trials did not report improvements in health outcomes with chelation therapy, and, as evidence, the case series are inadequate to determine efficacy. The evidence is insufficient to determine the effect of the technology on health outcomes.

Definiciones

Heavy metals refer to metals such as mercury, lead, chromium, arsenic, and cadmium, which have known toxic effects on internal organs (i.e., kidneys, brain, bone, retina).

Hemochromatosis is a genetic disease marked by excessive absorption and accumulation of iron into the body.

Thalassemia refers to a group of hereditary anemias occurring in populations bordering the Mediterranean and in Southeast Asia.

Exención de responsabilidad

Las políticas médicas de Capital Blue Cross se utilizan para determinar la cobertura de tecnologías, procedimientos, equipos y servicios médicos específicos. Estas políticas médicas no constituyen asesoramiento médico y están sujetas a cambios según lo exija la ley o las pruebas clínicas aplicables de las directrices de tratamiento independientes. Los proveedores que brindan tratamiento son individualmente responsables de los consejos médicos y el tratamiento de los miembros. Estas políticas no son una garantía de cobertura o pago. El pago de las reclamaciones está sujeto a la determinación del programa de beneficios del miembro y la elegibilidad en la fecha del servicio, y a la determinación de que los servicios son médicamente necesarios y apropiados. Final processing of a claim is based upon the terms of contract that applies to the member's benefit program, including benefit limitations and exclusions. Si un proveedor o miembro tiene alguna pregunta sobre esta política médica, debe comunicarse con Servicios para proveedores o Servicios para miembros de Capital Blue Cross.

Información de codificación

Note: This list of codes may not be all-inclusive, and codes are subject to change at any time. La identificación de un código en esta sección no denota cobertura, ya que la cobertura está determinada por los términos de la información de beneficios del miembro. Además, no todos los servicios cubiertos son elegibles para un reembolso por separado.

Investigational for all indications:

NaEDTA is considered not medically necessary as the FDA has removed approval for its use with chelation therapy; therefore, not covered:

Covered when medically necessary:

Referencias

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2. Food and Drug Administration. Hospira, Inc., et al.; Withdrawal of Approval of One New Drug Application and Two Abbreviated New Drug Applications. Federal Register. 2008; 73(119): 33440-33441.
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