mp-085 - Medical Policies - Credence
Policy Number: MP-085
Latest Review Date: February 2022
Chelation therapy may be considered medically necessary in the treatment of each of the following conditions when performed in the in-patient setting:
- Control of ventricular arrhythmias or heart block associated with digitalis toxicity;
- Emergency treatment of hypercalcemia;
- *Extreme conditions of metal toxicity (i.e. arsenic, cadmium, copper, mercury);
- Treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) and due to non-transfusion-dependent thalassemia (NDTD);
- Wilson's disease (hepatolenticular degeneration);
- Lead poisoning.
Chelation therapy for the treatment of sickle cell anemia, thalassemias, and iron overload in patients requiring frequent transfusion may be considered medically necessary when taken orally, or performed as an outpatient procedure, or given in the home health setting.
Chelation therapy in any form (IV, PO, transdermal, topical or rectal) is investigational when performed in an inpatient or outpatient setting to treat any other condition; including but not limited to, Alzheimer’s disease, atherosclerosis, myocardial infarction, autism, and diabetes.
Any treatment associated with non-covered chelation therapy (e.g. glutathione and vitamin C) is considered investigational.
*Chelation therapy performed to treat heavy metal and/or lead poisoning detected by a provocative urine test is considered not medically necessary.
DESCRIPTION OF PROCEDURE OR SERVICE:
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 consists of the 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.
There are a number of indications for chelation therapy that have received FDA approval and for which chelation therapy is considered standard of care treatment. These include:
- Extreme conditions of metal toxicity
- Treatment of chronic iron overload due to blood transfusions and due to non-transfusion dependent thalassemia
- Wilson disease
- Lead poisoning
- Control of ventricular arrhythmias or heart block associated with digitalis toxicity; and
- Emergency treatment of hypercalcemia
Chelation therapy has been investigated for a variety of other applications including treatment of atherosclerosis, arthritis, diabetes, multiple sclerosis, and autism. However, there is insufficient evidence that chelation therapy improves health outcomes for any condition other than those that have received FDA approval.
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. 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 β-amyloid protein by binding its metal-ion complex and also inhibit redox reactions that generate neurotoxic free radicals. Therefore, MPACs interrupt two putative pathogenic processes of Alzheimer’s disease. However, no MPACs have received U.S. Food and Drug Administration (FDA) approval for the treatment of Alzheimer’s disease.
This policy was updated with a literature search through November 15, 2021.
For individuals who have Alzheimer disease, cardiovascular disease, arthritis, autism, arthritis, diabetes, or multiple sclerosis who receive chelation therapy, the evidence includes a small number of RCTs and case series. Relevant outcomes include symptoms, change in disease status, morbid events, functional outcomes, health status measures, quality of life, and treatment-related morbidity. One RCT, the Trial to Assess Chelation Therapy (TACT), reported that chelation therapy reduced cardiovascular events in patients with a previous myocardial infarction and that the benefit was greater in diabetic patients compared with nondiabetic patients. However, this trial had significant limitations, including high dropout rates, and therefore conclusions are not definitive. For other conditions, the available RCTs 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 technology results in an improvement in net health outcomes.
Practice Guidelines and Position Statements
American Heart Association and American College of Cardiology
In 2016, the American College of Cardiology (ACC) and the American Heart Association (AHA) published a joint guideline on the management of patients with lower extremity peripheral artery disease, which recommended that chelation therapy (e.g., ethylenediaminetetraacetic acid) is not beneficial for the treatment of claudication.
In 2014, the ACC and AHA published a focused update of the guideline for the management of stable ischemic heart disease, in conjunction with the American Association for Thoracic Surgery, Preventative Cardiovascular Nurses Association, Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons. This update included a revised recommendation on chelation therapy stating that the “usefulness of chelation therapy is uncertain for reducing cardiovascular events in patients with stable IHD.” Compared to the original publication of this guideline in 2012, the recommendation was upgraded from a class III (no benefit) to class IIb (benefit ≥ risk), and the level of evidence from C (only consensus expert opinion, case studies, or standard of care) to B (data from a single randomized trial or nonrandomized studies).
American Academy of Pediatrics
In 2019, the American Academy of Pediatrics published guidance for the management of children with autism spectrum disorder. The guidance cautioned against the use of chelation therapy due to safety concerns and lack of supporting efficacy data.
U.S. Preventive Services Task Force Recommendations
Chelation therapy, toxic metal ions, dimercaprol, edetate calcium disodium, deferoxamine, penicillamine, Succimer, Desferal
APPROVED BY GOVERNING BODIES:
In 1953, calcium-ethylenediaminetetraacetic acid (EDTA; Versenate) was approved by the 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. 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, FDA withdrew approval of disodium-EDTA due to safety concerns and recommended that other forms of chelation therapy be used.
Several iron chelating agents have received FDA approval.
- Deferoxamine (Desferal®; Novartis) for subcutaneous, intramuscular or intravenous injections was approved for treating acute iron intoxication and chronic iron overload due to transfusion-dependent anemia. Several generic forms of deferoxamine have been approved by the FDA.
- In 2005, deferasirox (ExjadeÒ; Novartis) was approved by FDA and is available as a tablet for oral suspension and is indicated for the treatment of chronic iron overload due to blood transfusions in patients age 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 FDA approved the iron chelator deferiprone (Ferriporx®) for the treatment of patients with transfusional overload due to thalassemia syndromes when other 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, FDA advised that FDA-approved chelating agents are available by prescription only. There are no FDA-approved over-the-counter chelation products.
Coverage is subject to member’s specific benefits. Group specific policy will supersede this policy when applicable.
ITS: Home Policy provisions apply
FEP: Special benefit consideration may apply. Refer to member’s benefit plan. FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.
IV chelation therapy (chemical endarterectomy)
Injection, edetate calcium disodium, up to 1,000 mg
Injection, deferoxamine mesylate, 500 mg
Edetate disodium (EDTA, Diostate) per 150 mg
Home infusion therapy, chelation therapy; administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment, per diem.
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- Centers for Disease Control and Prevention (CDC). Deaths associated with hypocalcemia from chelation therapy--Texas, Pennsylvania, and Oregon, 2003-2005. MMWR Morb Mortal Wkly Rep 2006; 55(8):204-7.
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- 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. Am J Kidney Dis 2012;60(4):530-8.
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- 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.
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- 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.
- Escolar E, Ujueta F, Kim H, et al. Possible differential benefits of edetate disodium in post-myocardial infarction patients withdiabetes treated with different hypoglycemic strategies in the Trial to Assess Chelation Therapy (TACT). J DiabetesComplications. Aug 2020; 34(8): 107616.
- 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. Nov 4 2014; 64(18):1929-1949.
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- Food and Drug Administration. FDA warns consumers about potential health risks from using Thorne Research’s Captomer products. 2014 June 12; www.fda.gov/Drugs/DrugSafety/ucm400977.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. Accessed January 23, 2018
- George GN, et al. Mercury binding to the chelation therapy agents DMSA and DMPS and the rational design of custom chelators for mercury. Chemical Res Toxicology, August 2004; 17(8): 999-1006.
- Gerhard-Herman MD, Gornik HL, Barrett C, et al. 2016 AHA/ACC Guideline on the Management of Patients With LowerExtremity Peripheral Artery Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. Mar 21 2017; 135(12): e726-e779.
- 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):261-7.
- Harrison’s Textbook of Medicine, 13th edition, 1994.
- Harvard Heart Letter. Chelation therapy, April 2002.
- 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.
- Hyman SL, Levy SE, Myers SM, et al. Identification, Evaluation, and Management of Children With Autism Spectrum Disorder.Pediatrics. Jan 2020; 145(1).
- IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
- Jacobs DS, DeMott WR and Oxley DK. Laboratory test handbook. 5th edition. Lexi-Comp, Inc Cleveland, OH.
- Kempson IM, Lombi E. Hair analysis as a biomonitor for toxicology, disease and health status. Chem Soc Rev. Jul 2011;40(7):3915-3940.
- Knudtson ML, Wyse DG, Galbraith PD et al. Chelation therapy for ischemic heart disease: a randomized controlled trial. JAMA 2002; 287(4):481-6.
- 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. Jul 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. JAMA 2013; 309(12):1241-50.
- Lannfelt L, Blennow K, Zetterbert 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):779-86.
- Lewis EF, Ujueta F, Lamas GA, et al. Differential Outcomes With Edetate Disodium-Based Treatment Among Stable PostAnterior vs. Non-Anterior Myocardial Infarction Patients. Cardiovasc Revasc Med. Nov 2020; 21(11): 1389-1395.
- 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. Aug 2014; 30(8):837-849.
- Manual of Medical Therapeutics. The Washington Manual, 28th edition.
- 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. Jul 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. Jul 2014; 168(1):4-5.
- Mofenson Howard C. Acute poisonings, Rakel: Conn’s Current Therapy 54th edition, 2002.
- National Institute for Health and Care Excellence. Autism - management of autism in children and young people (clinical guidance 170), August 2013. Available online at: www.nice.org.uk/guidance/index.jsp?action=byID&o=14257. Accessed January 2018.
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- Ng DK, Chan CH, Soo MT et al. Low-level chronic mercury exposure in children and adolescents: meta-analysis. Pediatr Int 2007; 49(1):80-7.
- Nissen SE. Concerns about reliability in the Trial to Assess Chelation Therapy (TACT). JAMA 2013; 309(12):1293-4.
- 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):735-743.
- Risher JF, et al. Mercury exposure: evaluation and intervention the inappropriate use of chelating agents in the diagnosis and treatment of putative mercury poisoning. Neurotoxicology, August 2005; 26(4): 691-699.
- Ritchie CW, Bush AI, Mackinnon A et al. Metal-protein attenuation with Iodochlorhydroxyquin (clioquinol) targeting Aβ amyloid deposition and toxicity in Alzheimer disease: a pilot phase 2 clinical trial. Arch Neurol 2003; 60(12):1685-91.
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- Snow V, Barry P, Fihn SD et al. Primary care management of chronic stable angina and asymptomatic suspected or known coronary artery disease: a clinical practice guideline from the American College of Physicians. Ann Intern Med 2004; 141(7):562-7.
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- Ujueta F, Arenas IA, Escolar E, et al. The effect of EDTA-based chelation on patients with diabetes and peripheral arterydisease in the Trial to Assess Chelation Therapy (TACT). J Diabetes Complications. Jul 2019; 33(7): 490-494.
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Medical Policy Group, December 2002
Medical Policy Administration Committee, January 2003
Available for comment February 6-March 24, 2003
Medical Policy Group, December 2005 (1)
Medical Policy Group, January 2006 (1)
Medical Policy Administration Committee, February 2006
Available for comment March 1-April 14, 2006
Medical Policy Group, April 2006 (2)
Medical Policy Administration Committee, April 2006
Available for comment April 20-June 5, 2006
Medical Policy Group June 2006 (2)
Medical Policy Administration Committee, June 2006
Available for comment July 5-August 18, 2006
Medical Policy Group, June 2009 (1)
Medical Policy Administration Committee, July 2009
Available for comment July 1-August 14, 2009
Medical Policy Panel, April 2012
Medical Policy Group, April 2012 (2): Update Key Points, References, Governing Agencies information
Medical Policy Panel, June 2013
Medical Policy Group, September (2): Chronic iron overload due to non-transfusion-dependent thalassemia (NDTD) added to medically necessary statement based on new FDA approval. Secondary prevention in patients with myocardial infarction added to bullet point in investigational statement on atherosclerosis. Key Points and References updated to support policy changes. Old references removed.
Medical Policy Administration Committee, September 2013
Available for comment September 19 through November 2, 2013
Medical Policy Panel, June 2014
Medical Policy Group, June 2014 (4): Updated Key Points, Practice and Position Statement and References. No changes to the policy statement at this time.
Medical Policy Panel, June 2015
Medical Policy Group, June 2015 (4): Updates to Description, Key Points, Approved Governing Bodies, and References. Reworded Policy statement to clarify Chelation therapy in any form is considered investigational in the inpatient or outpatient setting for any other condition. Also reworded policy statement to clarify treatments associated with non-covered chelation therapy is considered investigational. No change to policy intent.
Medical Policy Panel, February 2016
Medical Policy Group, February 2016 (4): Updates to Key Points. Clarified policy statement by adding specific metal toxicities and added commas to separate sickle cell and thalassemia; edited category from therapy to pharmacology.
Medical Policy Panel, February 2017
Medical Policy Group, February 2017 (4): Updates to Key Points, Approved by Governing Bodies, and References; From Policy section, removed “Effective for dates of service prior to November 3, 2013” and policy statements pertaining to these dates.
Medical Policy Group, October 2017 (4): Added Key Word Desferal. No other changes.
Medical Policy Panel, February 2018
Medical Policy Group, February 2018 (4): Updates to Key Points and References. No change to policy statement.
Medical Policy Group, May 2018 (4): Added HCPCS code S9355 to Current Coding.
Medical Policy Panel, February 2019
Medical Policy Group, March 2019 (4): Updates to Key Points and References. No change to policy statements.
Medical Policy Panel, February 2020
Medical Policy Group, February 2020 (4): Updates to References. No change to policy statement.
Medical Policy Panel, February 2021
Medical Policy Panel, February 2021 (4): Updates to Key Points, Approved by Governing Bodies, and References. No change to policy statement.
Medical Policy Panel, February 2022
Medical Policy Group, February 2022 (4): Updates to Description, Approved Governing Bodies, and References. No change to policy statements. Removed the following referece: 2011 ACCF/AHA Focused Update of the Guideline for the Management of patients with peripheral artery disease (Updating the 2005 Guideline): a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Circulation. Nov 1 2011; 124(18):2020-2045.
This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.
This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.
The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.
As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.
The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:
1. The technology must have final approval from the appropriate government regulatory bodies;
2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;
3. The technology must improve the net health outcome;
4. The technology must be as beneficial as any established alternatives;
5. The improvement must be attainable outside the investigational setting.
Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:
1. In accordance with generally accepted standards of medical practice; and
2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and
3. Not primarily for the convenience of the patient, physician or other health care provider; and
4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.