Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Intravenous Chelation Therapy

Policy #:07.00.02i

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract.

MEDICALLY NECESSARY

Intravenous (IV) chelation therapy (the removal of toxic substances) using chelation agents that include, but are not limited to, deferasirox, deferiprone, deferoxamine mesylate, dimercaprol, edetate calcium disodium (calcium-ethylenediaminetetraacetic acid [EDTA]; calcium disodium EDTA), edetate disodium EDTA and succimer is considered medically necessary and, therefore, covered for the following indications:
  • Chronic iron overload due to blood transfusions (transfusional hemosiderosis) and due to non-transfusion-dependent thalassemia (NDTD)
  • Iron metabolism disorders (e.g., primary or secondary hemochromatosis)
  • Symptomatic digoxin toxicity (with subsequent ventricular arrhythmias or heart block)
  • Wilson’s disease (i.e., hepatolenticular degeneration, abnormal copper metabolism) (not to be confused with Wilson's syndrome)
  • Lead poisoning
  • Emergency treatment of hypercalcemia
  • Extreme metal toxicity or metal poisoning

Most individuals with heavy metal toxicity require chelation therapy two to six times a day, for two to five days, depending on the level of toxicity, the agent used, and the condition of the patient. In addition, they require close monitoring of their physical signs and symptoms, heavy metal levels, and resultant sequelae. Therefore, IV chelation therapy will be covered only in places of service that can provide this type of care.

EXPERIMENTAL/INVESTIGATIONAL

The use of IV chelation therapy for all other indications not listed in the policy, including, but not limited to, the list below, is considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness cannot be established by review of the available published peer-reviewed literature.
  • Alzheimer’s disease
  • Arthritis (includes rheumatoid arthritis)
  • Atherosclerosis (e.g., coronary artery disease, secondary prevention in individuals with myocardial infarction, or peripheral vascular disease)
  • Autism
  • Diabetes
  • Multiple sclerosis

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.
Guidelines

The following levels are commonly used to indicate toxicity:
  • Arsenic - 24-hour urine: 50 μg/L urine or 100 μg/g creatinine
  • Bismuth - No clear reference standard
  • Cadmium - Proteinuria and/or ≥15 μg/g creatinine
  • Chromium - No clear reference standard
  • Cobalt - Normative excretion: 0.1-1.2 μg/L (serum), 0.1-2.2 μg/L (urine)
  • Copper - Normative excretion: 25 μg/24 h (urine)
  • Iron
    • Nontoxic: <300 μg/dL
    • Severe: >500 μg/dL
  • Lead
    Pediatric
    • Symptoms or blood lead level ≥45 μg/dL (blood)
    • CDC level of concern: 5 μg/dL
    Adult
    • Symptoms or blood lead level ≥70 μg/dL
    • CDC level of concern: 10 μg/dL
  • Manganese - No clear reference standard
  • Mercury - Background exposure normative limits: 1-8 μg/L (whole blood); 4-5 μg/L (urine)
  • Nickel
    • Excessive exposure: ≥8 μg/L (blood)
    • Severe poisoning: ≥500 μg/L (8-h urine)
  • Selenium
    • Mild toxicity: >1 mg/L (serum)
    • Serious toxicity: >2 mg/L
  • Silver - Asymptomatic workers have mean levels of 11 μg/L (serum) and 2.6 μg/L (spot urine)
  • Thallium - 24-hour urine thallium >5 μg/L
  • Zinc - Normative range: 0.6-1.1 mg/L (plasma), 10-14 mg/L (red cells)

The definitive methodology for the detection of heavy metal toxicity in blood and urine is atomic absorption spectrometry. It is not appropriate to use hair testing analysis or laboratory standard deviation parameters to indicate heavy metal toxicity.

Intravenous (IV) chelation therapy and the chelating agent are each covered and eligible for separate reimbursement.

Edetate disodium (Healthcare Common Procedure Coding System [HCPCS] code J3520) is indicated in select individuals for the emergency treatment of severe, acute hypercalcemia. Although also indicated and available for the control of ventricular arrhythmias associated with digitalis toxicity, edetate disodium has been replaced by digoxin immune Fab therapies as first-line treatment for life-threatening digitalis toxicity.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, IV chelation therapy is covered under the medical benefits of the Company’s products when medical necessity criteria in this medical policy are met.

Description

The human body contains small quantities of certain heavy metals, such as iron and copper, that (in the proper concentration) are essential for normal bodily function and are considered to be micronutrients. The body also contains nonessential heavy metals, such as lead and aluminum, that are not used for biological processes. When any of these types of heavy metals build up in the body, whether through a metabolic dysfunction or from ingestion, they can reach toxic levels, which can lead to serious, and even fatal, health effects. Intravenous (IV) chelation therapy (also known as chemical endarterectomy) is a method of removing these toxic substances (e.g., lead, zinc, iron, copper, calcium) from the body.

IV chelation agents reduce the accumulation of heavy metals by binding with the metal ions. This binding effect enhances urinary and fecal excretion, through which the toxic metals are removed, which in turn reverses the toxic effects. Specific chelating agents are used for the treatment of certain heavy metal toxicities. For example, desferroxamine is used for patients with iron toxicity and calcium-ethylenediaminetetraacetic acid (calcium-EDTA) is used in the treatment of lead poisoning. IV chelation therapy is also used to reverse the effects of digoxin toxicity in individuals with ventricular irregularity and heart block, and it is used as a pharmacologic treatment in the long-term management of certain inherited diseases (e.g., Wilson's disease, which is a disorder of copper overload with a pathological impact on the liver).

Individuals experiencing toxicity may require IV chelation therapy two to six times a day, for two to five days, depending on the level of toxicity, the agent used, and the condition of the individual. The definitive methodology for the detection of heavy metal toxicity in blood and urine is atomic absorption spectrometry.

PEER-REVIEWED LITERATURE

ALZHEIMER'S DISEASE
A class of chelating agents, metal protein-attenuating compounds (MPACs), has been investigated for the treatment of Alzheimer’s disease. MPACs have been evaluated as treatment options for Alzheimer’s disease due to the association of the disease with the disequilibrium of cerebral metals and the agent’s subtle effects on metal homeostasis and abnormal interactions (e.g., the promotion of solubilization and clearance of Aß-amyloid protein etc). No MPACs have received U.S. Food and Drug Administration (FDA) approval for the treatment of Alzheimer’s disease.

The Cochrane Collaboration published results from a systematic review intended to evaluate the efficacy of MPACs for the treatment of cognitive impairment due to Alzheimer’s disease (2008). The authors identified a single randomized trial of MPACs in Alzheimer's disease. The included trial compared the clioquinol (PBT1) with placebo in n=36 patients; however, the results showed no statistically significant difference in cognition between active treatment and placebo groups at 36 weeks. The authors of the systematic review therefore concluded that there is an absence of evidence as to whether clioquinol (PBT1) has any positive clinical benefit for patients with Alzheimer’s disease, or whether the drug is safe.

ARTHROSCLEROSIS
The Cochrane Collaboration published the results from a systematic review intended to assess the effects of ethylene diamine tetraacetic acid (EDTA) chelation therapy on clinical outcomes among individuals with atherosclerotic cardiovascular disease (2002). The authors identified five randomized placebo-controlled trials that fulfilled their inclusion/exclusion criteria. Four of the 5 identified trials, with a combined study population of n=250 individuals, found no significant difference in outcomes related to direct or indirect measurements of disease severity and subjective measures of disease improvement. The remaining study was reported as being stopped early due to an apparent positive treatment effect; however, relevant data were not presented. None of the identified trials reported data regarding mortality, non-fatal events, and cerebrovascular vascular events. Based on the results from the systematic review, the authors concluded that there was insufficient evidence to draw conclusions for the efficacy of chelation therapy for treating atherosclerosis.

An additional systematic review, similarly intended to evaluate the best available evidence for the use of EDTA chelation therapy in the treatment of cardiovascular disease, was conducted by Seely et al. in 2005. The Seely et al. workgroup identified two additional trials that were not included in the aforementioned Cochrane review, but concurrently concluded that the best available evidence does not support the therapeutic use of EDTA chelation therapy in the treatment of cardiovascular disease.

AUTISM
Similarities between mercury poisoning and autism spectrum disorders (ASD) have previously prompted the development of a hypothesized link between environmental mercury and autism. In a subsequent meta-analysis Ng et al. (2007) reviewed the available data on the nature, pathophysiology, pharmacokinetics, diagnostic methods, treatment, and the linkage to neurodevelopmental disabilities of mercury exposure in children. Based on the available data and a subsequent meta-analysis, the Ng et al. workgroup concluded that there was no evidence to support the association between mercury poisoning and autism.

An additional systematic review, published by Rossignol in 2009, reviewed the currently novel and emerging treatments for autism spectrum disorders (ASD), including chelation therapy. Literature searches, conducted by the reviewer, identified multiple publications, although the available data presented with methodological flaws, most notably the unanimous lack of control groups. The authors ultimately concluded that the available data suggest that chelation might be a viable form of treatment in some individuals with an ASD who have elevated heavy metal burden, while dually acknowledging the limitations of the available data (e.g., lack of comparisons or controls, heterogeneous study populations, etc) and the need for further evaluation in controlled studies.

Clinical practice guidelines published in 2012 and 2013 by the National Institute for Health and Clinical Excellence (NICE) addressing autism in adults and children do not recommend the use of chelation therapy for the management of core symptoms of autism in adults and children.

DIABETES
In 2009, Cooper and colleagues in New Zealand reported the results of a 12 month randomized, placebo-controlled study evaluating the effects of copper chelation using oral trientine on left ventricular hypertrophy (LVH) in 30 patients (n=15/group at baseline) with type 2 diabetes. Participants, caregivers, and those assessing outcomes were blinded to group assignment. Left ventricular variables were measured at baseline, at 6 months, and at 12 months. Twenty-one (70%) of 30 participants completed 12 months of follow-up. At 12 months, there was a significantly greater reduction in left ventricular mass indexed to body surface area (LVMbsa) in the active treatment group compared with the placebo group (-10.6 g/m2 vs -0.1 g/m2, p=0.0088). The authors concluded that copper chelation "merits further exploration as a potential pharmacotherapy for diabetic heart disease". The study was limited by the small sample size and high dropout rate.

In 2012, Chen and colleagues in China reported the results of a 24 month single-blind, randomized controlled trial, of chelation therapy effects on the progression of diabetic nephropathy in patients with high-normal lead levels. Fifty patients with diabetes and high-normal body lead levels were randomized to the treatment (weekly chelation therapy [EDTA] for 3 months to reduce their body lead levels to <60 micrograms and then as needed for 24 months to maintain this level) or control (placebo for 3 months and then weekly for 5 weeks at 6 month intervals for 24 months) groups. All patients completed the 27-month trial. The primary outcome measured was change in estimated glomerular filtration rate (eGFR). A secondary end point measured was the number of patients in whom the baseline serum creatinine doubled or who required renal replacement therapy. Mean yearly rate of decrease in eGFR was 5.6 mL/min/1.73 m2 in the chelation group and 9.2 mL/min/1.73 m2 in the control group (p=0.04). Nine patients (36%) in the treatment group and 17 patients (68%) in the control group attained the secondary end point (p=0.02). The study was limited by the small sample size and not being double-blinded.

MYOCARDIAL INFARCTION
In 2013, the National Center for Complementary and Alternative Medicine (NCCAM) and the National Heart, Lung, and Blood Institute (NHLBI) published results from the Trial to Assess Chelation Therapy (TACT). The double-blind, placebo-controlled, 2x2 factorial randomized trial was designed to evaluate if an EDTA-based chelation regimen will reduce cardiovascular events in patients with a history of myocardial infarction (MI) (Lamas et al. 2013). The TACT trial enrolled n=1708 individuals (originally designed to enroll n=2300 individuals) aged 50 years or older who had experienced a myocardial infarction (MI) at least 6 weeks prior to enrollment. Enrolled individuals were randomized to receive 40 infusions of either chelation solution (3 g of disodium EDTA, 7g of ascorbate, B vitamins, electrolytes, procaine, and heparin) (n=839) or placebo (500 mL of normal saline and 1.2% dextrose) (n=869). Participants were evaluated at baseline and at each of the 40 infusion visits. Following the infusion phase of the trial, patients were contacted quarterly by telephone, had annual clinic visits, and were seen at the end of the trial or at 5-year follow-up, whichever occurred first. The primary endpoint of the study was a composite of all-cause mortality, myocardial infarction (MI), stroke, coronary revascularization, and hospitalization for angina. Additional secondary endpoints were a composite of cardiovascular death, non-fatal MI, or non-fatal stroke. Additional pre-specified subgroups, including underrepresented populations (women and minorities), elderly persons (aged 70 years or older), high-risk patients (MI location, diabetes, and metabolic syndrome) were assessed. The interaction of the chelation therapy with the oral high-dose vitamin and mineral component of the trial and with the type of enrolling site (chelation practice vs. not a chelation practice) was also evaluated. A total of 361 patients in the chelation group (43%) and 464 patients in the placebo group (57%) discontinued treatment after starting it, withdrew consent during follow-up, or were lost to follow-up.

The Lamas et al. workgroup observed primary endpoint events among 222 (26%) individuals in the chelation group and 261 (30%) in the placebo group (hazard ratio [HR], 0.82 [95% CI, 0.69-0.99]; P=.035). No effect on total mortality was observed (chelation, 87 deaths [10%]; placebo, 93 deaths [11%]; HR, 0.93 [95% CI, 0.70-1.25]; P=.64); although the study was not statistically powered for this comparison. The effect of EDTA treatment on the individual elements of the primary endpoint was similar to the overall effect on the composite primary endpoint (MI/chelation, 6%; placebo, 8%; HR, 0.77 [95% CI, 0.54-1.11]; stroke/chelation, 1.2%; placebo, 1.5%; HR, 0.77 [95% CI, 0.34-1.76]; coronary revascularization/chelation, 15%; placebo, 18%; HR, 0.81 [95% CI, 0.64-1.02]; hospitalization for angina/chelation, 1.6%; placebo, 2.1%; HR, 0.72 [95% CI, 0.35-1.47]). The pre-specified subgroup analysis did not identify any significant interaction. Considering these results, the authors concluded that among patients with a history of MI, EDTA chelation regimens moderately reduced the risk of cardiovascular outcomes, but the results are not sufficient to support the routine use of chelation therapy in this particular patient population. The results of the trial are limited by low and disproportionate follow-up rates between study groups, including a greater number of patients who withdrew consent in the placebo group compared to the treatment group, as well primary endpoint-containing components of varying levels of clinical significance.

SUMMARY
IV chelation has been accepted as a treatment option for a number of indications, particularly for the treatment of various metal toxicities, as well as transfusional hemosiderosis, among other indications. The safety and effectiveness of chelation therapy for the treatment of additional indications (e.g., Alzheimer's disease, arthritis, arthrosclerosis, autism, diabetes, hypoglycemia, multiple sclerosis, myocardial infarction, etc.) is being investigated within clinical research settings; however, the effectiveness of chelation therapy in the treatment of these indications has not been demonstrated within well-designed, controlled clinical trials.

PRACTICE GUIDELINES AND POSITION STATEMENTS
In 2012, the American College of Physicians, American College of Cardiology Foundation, American
Heart Association, American Association for Thoracic Surgery, Preventive Cardiovascular Nurses Association, and Society of Thoracic Surgeons published a clinical practice guideline on the management of stable ischemic heart disease (IHD). The guidelines recommended that “chelation therapy should not be used with the intent of improving symptoms or reducing cardiovascular risk in patients with stable IHD. (Grade: strong recommendation; low-quality evidence)”

In 2005, the American College of Cardiology and the American Heart Association stated that chelation “is not indicated for treatment of intermittent claudication and may have harmful adverse effects. (Level of Evidence A: Data derived from multiple randomized clinical trials or meta-analyses.)”

A 2004 clinical practice guideline from the American College of Physicians stated that chelation “should not be used to prevent myocardial infarction or death or to reduce symptoms in patients with symptomatic chronic stable angina. (Level of evidence B: Based on evidence from a limited number of randomized trials with small numbers of patients, careful analyses of nonrandomized studies, or observational registries.)”
References


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Agency for Toxic Substances and Disease Registry. Toxicological profile for mercury. March 1999. Available at: https://www.atsdr.cdc.gov/ToxProfiles/tp46.pdf. Accessed September 14, 2018.

Anderson JL, Halperin JL, Albert NM, et al. Management of patients with peripheral artery disease (compilation of 2005 and 2011 ACCF/AHA guideline recommendations): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2013;127(13):1425-1443.

Anderson TJ, Hubacek J, Wyse DG, et al. Effect of chelation therapy on endothelial function in patients with coronary artery disease PATCH substudy. J Am Coll Cardiol. 2003;41(3) 420-425.

Bauchner H, Fontanarosa PB, Golub, RM. Evaluation of the Trial to Assess Chelation Therapy (TACT), the scientific process, peer review, and editorial scrutiny evaluation of the Trial to Assess Chelation Therapy. JAMA. 2013;309(12):1291-1292.

Bernard S, Enayati A, Redwood L, et al. Autism: a novel form of mercury poisoning. Med Hypotheses. 2001;56(4):462-471.

Centers for Disease Control and Prevention (CDC). Emergency preparedness and response. Case definition: thallium. November 18, 2015. Available at: http://emergency.cdc.gov/agent/thallium/casedef.asp. Accessed September 14, 2018.

Centers for Disease Control and Prevention (CDC). Managing elevated blood lead levels among young children Recommendations from the Advisory Committee on Childhood Lead Poisoning Prevention. [CDC Web site]. 03/01/2002. Available at: http://www.cdc.gov/nceh/lead/casemanagement/casemanage_main.htm. Accessed September 14, 2018.

Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD) for CHELATION THERAPY for Treatment of Atherosclerosis (20.21). Available at:https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=86&ncdver=1&DocID=20.21&bc=gAAAABAAAAAA&. Accessed September 14, 2018.

Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD) for EthylenediamineTetra-Acetic (EDTA) CHELATION THERAPY for Treatment of Atherosclerosis (20.22). Available at: https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=146&ncdver=1&DocID=20.22&bc=gAAAABAAAAAA&. Accessed September 14, 2018.

Chen KH, Lin JL, Lin-Tan DT et al. Effect of chelation therapy on progressive diabetic nephropathy in patients with type 2 diabetes and high-normal body lead burdens. American journal of kidney diseases : the official journal of the National Kidney Foundation. 2012; 60(4):530-8.

Cooper GJ, Young AA, Gamble GD et al. A copper(II)-selective chelator ameliorates left-ventricular hypertrophy in type 2 diabetic patients: a randomized placebo-controlled study. Diabetologia. 2009; 52(4):715-22.

Dans AL, Tan FN, Villarruz-Sulit EC. Chelation therapy for atherosclerotic cardiovascular disease. Cochrane Database Syst Rev. 2002;4:CD002785.

Ernst E. Chelation therapy for coronary heart disease An overview of all clinical investigations. Am Heart J. 2000;140(1) 139-141.

Ernst E. Chelation therapy for peripheral arterial occlusive disease a systematic review. Circulation. 1997;96(3) 1031-1033.

Escolar E, Lamas GA, Mark DB et al. 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. Cardiovascular quality and outcomes. 2014; 7(1):15-24.

Fihn SD, Blankenship JC, Alexander KP, et al. 2014 ACC/AHA/AATS/PCNA/SCAI/STS focused update of the guideline for the diagnosis and management of patients with stable ischemic heart disease: a report of the 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. J Am Coll Cardiol. 2014;64(18):1929-1949.

Grolez G, Moreau C, Sablonniere B, et al. Ceruloplasmin activity and iron chelation treatment of patients with Parkinson's disease. BMC Neurol. 2015;15:74.

Guldager B, Jelnes R, Jorgensen SJ, et al. EDTA treatment of intermittent claudication--a double-blind, placebo-controlled study. J Intern Med. 1992;231(3) 261-267.

Hirsch AT, Haskal ZJ, Hertzer NR et al. ACC/AHA 2005 Practice Guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, mesenteric, and abdominal aortic): a collaborative report from the American Association for Vascular Surgery/Society for Vascular Surgery, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, Society of Interventional Radiology, and the ACC/AHA Task Force on Practice Guidelines (Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease): endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; and Vascular Disease Foundation. Circulation. 2006; 113(11):e463-654.

Klaassen CD. Heavy metal and heavy-metal antagonists. In Goodman LS, Limbird LE, Molinoff PB, Ruddon RW, Gilman AG, eds. Goodman and Gilman’sThe Pharmacological Basis of Therapeutics. 9th ed. New York, NY McGraw-Hill Co.; 1996: 1649-1671.

Knudtson ML, Wyse DG, Galbraith PD, et al. Chelation therapy for ischemic heart disease a randomized controlled trial. JAMA. 2002;287(4) 481-486.

Lamas, Gervasio A, et al. Design of the trial to assess chelation therapy (TACT). Am Heart J.2012;163(1):7-12.

Lamas GA, Boineau R, Goertz C, et al. EDTA chelation therapy alone and in combination with oral high-dose multivitamins and minerals for coronary disease: The factorial group results of the Trial to Assess Chelation Therapy. Am Heart J. 2014;168(1):37-44 e35.

Lamas GA, Goertz C, Boineau R, et al. Effect of disodium EDTA chelation regimen on cardiovascular events in patients with previous myocardial infarction. The TACT Randomized Trial: Disodium EDTA Chelation in Patients With Previous MI. JAMA. 2013;309(12):1241-1250.

Lannfelt L, Blennow K, Zetterberg H, et al. Safety, efficacy, and biomarker findings of PBT2 in targeting Abeta as a modifying therapy for Alzheimer's disease: a phase IIa, double-blind, randomised, placebo-controlled trial. Lancet Neurol. 2008;7(9):779-786.

Mancini GB, Gosselin G, Chow B, et al. Canadian Cardiovascular Society guidelines for the diagnosis and management of stable ischemic heart disease. Can J Cardiol. 2014;30(8):837-849.

Mark DB, Anstrom KJ, Clapp-Channing NE, et al. Quality-of-life outcomes with a disodium EDTA chelation regimen for coronary disease: results from the trial to assess chelation therapy randomized trial. Circ Cardiovasc Qual Outcomes. 2014;7(4):508-516.

Maron DJ, Hlatky MA. Trial to Assess Chelation Therapy (TACT) and equipoise: When evidence conflicts with beliefs. Am Heart J. 2014;168(1):4-5.

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National Institute for Health and Clinical Excellence (NICE). Autism in under 19s: support and management. [NICE Web site]. August 2013. Available at: http://www.nice.org.uk/guidance/cg170. Accessed September 14, 2018.

Nelson KB, Bauman ML. Thimerosal and autism? Pediatrics. 2003;111(3):674-679.

Ng DK, Chan CH, Soo MT, et al. Low-level chronic mercury exposure in children and adolescents: meta-analysis. Pediatr Int. 2007;49(1):80-87.

Nissen SE. Concerns about reliability in the Trial to Assess Chelation Therapy (TACT): concerns about reliability in TACT. JAMA. 2013;309(12):1293-1294.

Olivieri NF. Orally active iron chelators in the treatment of iron overload. Curr Opin Hematol. 1996;3(2) 125-130.

Piomelli S. Recent advances in the management of thalassemia. Curr Opin Hematol. 1995;2(2) 159-163.

Porter JB. A risk-benefit assessment of iron-chelation therapy. Drug Saf. 1997;17(6) 407-421.

Qaseem A, Fihn SD, Dallas P et al. Management of Stable Ischemic Heart Disease: Summary of a Clinical Practice Guideline From the American College of Physicians/American College of Cardiology Foundation/American Heart Association/American Association for Thoracic Surgery/Preventive Cardiovascular Nurses Association/Society of Thoracic Surgeons. Annals of Internal Medicine. 2012; 157(10):735-43.

Ritchie CW, Bush AI, Mackinnon A et al. Metal-protein attenuation with Iodochlorhydroxyquin (clioquinol) targeting Aß amyloid deposition and toxicity in Alzheimer disease: a pilot phase 2 clinical trial. Arch Neurol. 2003; 60(12):1685-91.

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Villarruz MV, Dans A, Tan F. Chelation therapy for atherosclerotic cardiovascular disease. Cochrane Database Syst Rev. 2002; (4):CD002785.

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Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

See Attachment A


HCPCS Level II Code Number(s)



J0470 Injection, dimercaprol, per 100 mg

J0600 Injection, edetate calcium disodium, up to 1,000 mg

J0895 Injection, deferoxamine mesylate, 500 mg

J3520 Edetate disodium, per 150 mg

M0300 IV chelation therapy (chemical endarterectomy)

S9355 Home infusion therapy, chelation therapy; administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment (drugs and nursing visits coded separately), per diem

THE FOLLOWING CODE SHOULD BE USED WHEN REPORTING THESE THREE AGENTS DEFERASIROX, DEFERIPRONE, AND SUCCIMER:

J8499 Prescription drug, oral, nonchemotherapeutic, NOS



Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References

Attachment A: Intravenous Chelation Therapy
Description: ICD-10 Codes




Policy History

Revisions from 07.00.02i:
03/04/2019The following language was added to the Experimental/Investigational section after Atherosclerosis:
    (e.g., coronary artery disease, secondary prevention in individuals with myocardial infarction, or peripheral vascular disease)

Myocardial infarction in the Experimental/Investigational section was incorporated under Atherosclerosis.

The following chelation agents were added to the list of chelation agents: deferasirox, deferiprone, succimer.

Language listing the types of place of service was removed from the Policy Section.

In the Policy Guidelines section, the list of heavy metal levels that are commonly used to indicate toxicity was updated.

Attachment A was created for the ICD-10 Diagnosis Codes, and the following ICD-10 codes were added to this policy:
    E83.59, R78.71, R78.79, R79.0, T56.2X1A, T56.2X1D, T56.2X1S, T56.2X2A, T56.2X2D, T56.2X2S, T56.2X3A, T56.2X3D, T56.2X3S, T56.2X4A, T56.2X4D, T56.2X4S, T56.91XA, T56.91XD, T56.91XS, T56.92XA, T56.92XD, T56.92XS, T56.93XA, T56.93XD, T56.93XS, T56.94XA, T56.94XD, T56.94XS

The following HCPCS code was added to the policy to report Deferasirox, Deferiprone, and Succimer: J8499

The following header was removed from the HCPCS coding table:

Chelation agents require close monitoring of physical signs and symptoms, heavy metal levels, and resultant sequelae, and will be covered only in places of service that can provide this type of care (e.g., renal dialysis facilities, skilled nursing facilities). The following code would only be covered in this type of setting


Effective 10/05/2017 this policy has been updated to the new policy template format.


Version Effective Date: 03/04/2019
Version Issued Date: 03/04/2019
Version Reissued Date: N/A

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