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«PacifiCare’s medical management guidelines represent the recommendation of the PacifiCare Medical Management Guideline (MMG) committee. They are ...»

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Autism Spectrum Disorder: Chelation therapy has been proposed to treat patients with autism based on the theory that the chelating agent will remove mercury from children with autism. Some studies have evaluated the use of chelation for treating autism (Patel, 2007); however, no studies have proven the effectiveness of chelation for this indication. In 2008, the National Institute of Mental Health called off a study on chelation to treat autism in children. The study was put on hold due to safety concerns after another study linked a drug used in the treatment to brain problems in rats. Scientists had planned to test a chelation drug on autistic children to investigate whether mercury in childhood vaccines causes the disorder. (Smart Brief, 2008) Professional Societies American Cancer Society (ACS): In 2007, the ACC stated that chelation therapy is a proven treatment for lead poisoning and poisoning from other heavy metals. However, available scientific evidence does not support claims that the treatment benefits patients with cancer, heart disease, or any medical problems other than heavy-metal poisoning.

(ACS, 2007) American College of Cardiology (ACC): The ACC concluded in 2005 that there is insufficient scientific evidence to justify the application of chelation therapy for atherosclerosis on a clinical basis. At the present time, therefore, chelation therapy should be applied only under an investigational protocol. (Vogel, 2005) American Heart Association (AHA): The AHA's Clinical Science Committee has reviewed the available literature on the use of chelation (EDTA) in the treatment of arteriosclerotic heart or blood vessel disease and finds no scientific evidence to demonstrate any benefit of this form of therapy. Furthermore, employment of this form of unproven treatment may deprive patients of the well-established benefits attendant to the many other valuable methods of treating these diseases. (AHA, 2009) American College of Physicians (ACP): A clinical practice guideline published in 2004 by the ACP recommended against the use of chelation therapy to prevent myocardial infarction or to reduce symptomatic angina. (Snow, 2004) Additional Medical Products Pencillamine or Depen® Additional Search Terms 1,2-dimethyl-3-hydroxypyrid-4-one, CGP 37 391, CP20, cupriuresis, DFX, DMHP, INN, lead encephalopathy, N,N'-bis (o-hydroxybenzyl) ethylenediamine-N, N'-diacetic acid, plumbism Chelation Therapy - Commercial Medical Management Guideline References and Resources Resources Addis A, Loebstein R, Koren G, Einarson TR. Meta-analytic review of the clinical effectiveness of oral deferiprone (L1).

Eur J Clin Pharmacol. 1999;55(1):1-6.

American Academy of Pediatrics (AAP). Aluminum toxicity in infants and children. Pediatrics. 1996;97(3):413-416.

American Academy of Pediatrics (AAP) Committee on Environmental Health. Lead exposure in children: prevention, detection, and management. Pediatrics. 2005 Oct;116(4):1036-46.

American Cancer Society (ACS). Chelation Therapy. July 20, 2007. Available at:

http://www.cancer.org/docroot/ETO/content/ETO_5_3x_Chelation_Therapy.asp. Accessed March 13, 2009.

American Heart Association (AHA) [Web site]. Questions and Answers About Chelation Therapy. 2009. Available at:

http://www.americanheart.org/presenter.jhtml?identifier=3000843. Accessed March 13, 2009.

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.

Barata JD, D'Haese PC, Pires C, et al. Low-dose (5 mg/kg) desferrioxamine treatment in acutely aluminum-intoxicated haemodialysis patients using two drug administration schedules. Nephrol Dial Transplant. 1996;11(1):125-132.

Bellinger DC, Trachtenberg F, Barregard L, Tavares M, Cernichiari E, Daniel D, McKinlay S. Neuropsychological and renal effects of dental amalgam in children: a randomized clinical trial. JAMA. 2006 Apr 19;295(15):1775-83.

Cappellini MD, Cohen A, Piga A, et al. A phase 3 study of deferasirox (ICL670), a once-daily oral iron chelator, in patients with beta-thalassemia. Blood. 2006 May 1;107(9):3455-62.

Caro J, Huybrechts KF, Green TC. Estimates of the effect on hepatic iron of oral deferiprone compared with subcutaneous desferrioxamine for treatment of iron overload in thalassemia major: a systematic review. BMC Blood Disord. 2002;2(1):4. Available at: http://www.biomedcentral.com/1471-2326/2/4. Accessed February 24, 2009.

Chisolm JJ Jr. Safety and efficacy of meso-2,3-dimercaptosuccinic acid (DMSA) in children with elevated blood lead concentrations. J Toxicol Clin Toxicol. 2000;38(4):365-375.

Crapper McLachlan DR, Dalton AJ, Kruck TP, et al. Intramuscular desferrioxamine in patients with Alzheimer's disease.

Lancet. 1991;337(8753):1304-1308.

DeRouen TA, Martin MD, Leroux BG, Townes BD, Woods JS, Leitao J, Castro-Caldas A, Luis H, Bernardo M, Rosenbaum G, Martins IP. Neurobehavioral effects of dental amalgam in children: a randomized clinical trial. JAMA.

2006 Apr 19;295(15):1784-92.

Dietrich KN, Ware JH, Salganik M, Radcliffe J, Rogan WJ, Rhoads GG, Fay ME, Davoli CT, Denckla MB, Bornschein RL, Schwarz D, Dockery DW, Adubato S, Jones RL; Treatment of Lead-Exposed Children Clinical Trial Group. Effect of chelation therapy on the neuropsychological and behavioral development of lead-exposed children after school entry.

Pediatrics. 2004 Jul;114(1):19-26.

Ghio AJ, Piantadosi CA, Crumbliss AL. Hypothesis: iron chelation plays a vital role in neutrophilic inflammation.

Chelation Therapy - Commercial Medical Management Guideline Biometals. 1997;10(2):135-142.

Knudtson ML, Wyse DG, Galbraith PD, et al. Chelation therapy for ischemic heart disease: a randomized controlled trial.

JAMA. 2002;287(4):481-486.

Kolaric K, Bradamante V, Cervek J, et al. A phase II trial of cardioprotection with cardioxane (ICRF-187) in patients with advance breast cancer receiving 5-fluorouracil, doxorubicin and cyclophosphamide. Oncology. 1995;52(3):251-255.

Lin JL, Ho HH, Yu CC. Chelation therapy for patients with elevated body lead burden and progressive renal insufficiency. A randomized, controlled trial. Ann Intern Med. 1999;130(1):7-13.

Lin-Tan DT, Lin JL, Yen TH, Chen KH, Huang YL. Long-term outcome of repeated lead chelation therapy in progressive non-diabetic chronic kidney diseases. Nephrol Dial Transplant. 2007 Oct;22(10):2924-31.

Markowitz ME, Bijur PE, Ruff H, Rosen JF. Effects of calcium disodium versenate (CaNa2EDTA) chelation in moderate childhood lead poisoning. Pediatrics. 1993;92(2):265-271.

O'Connor ME, Rich D. Children with moderately elevated lead levels: is chelation with DMSA helpful? Clin Pediatr (Phila). 1999;38(6):325-331.

Olivieri NF, Brittenham GM, Matsui D, et al. Iron-chelation therapy with oral deferiprone in patients with thalassemia major. N Engl J Med. 1995;332(14):918-922.

Olivieri NF, Nathan DG, MacMillan JH, et al. Survival in medically treated patients with homozygous beta-thalassemia.

N Engl J Med. 1994;331(9):574-578.

Patel K, Curtis LT. A comprehensive approach to treating autism and attention-deficit hyperactivity disorder: a prepilot study. J Altern Complement Med. 2007 Dec;13(10):1091-7.

Regland B, Lehmann W, Abedini I, et al. Treatment of Alzheimer's disease with clioquinol. Dement Geriatr Cogn Disord.2001;12(6):408-414.

Richardson ME, Matthews RN, Alison JF, et al. Prevention of heart disease by subcutaneous desferrioxamine in patients with thalassemia major. Aust N Z J Med. 1993;23(6):656-661.

Ritchie CW, Bush AI, Mackinnon A, et al. Metal-protein attenuation with iodochlorhydroxyquin (clioquinol) targeting Ab amyloid deposition and toxicity in Alzheimer Disease. Arch Neurol. 2003;60(12):1685-1691.

Rogan WJ, Dietrich KN, Ware JH, and Treatment of Lead-Exposed Children Trial Group. The effect of chelation therapy with succimer on neuropsychological development in children exposed to lead. N Engl J Med. 2001;344(19):1421-1426.

Roger SD, Stewart JH, Harris DC. Desferrioxamine enhances the haemopoietic response to erythropoietin, but adverse events are common. Nephron. 1991;58(1):33-36.

Rosen JF, Markowitz ME. Trends in the management of childhood lead poisonings. Neurotoxicology. 1993;14(2-3):211Seely DM, Wu P, Mills EJ. EDTA chelation therapy for cardiovascular disease: a systematic review. BMC Cardiovasc Disord. 2005 Nov 1;5:32.

Chelation Therapy - Commercial Medical Management Guideline

Smart Brief. Web site. 2008. NIH branch drops study of chelation as autism treatment. Available at:

http://www.smartbrief.com/news/FDLI/storyDetails.jsp?issueid=1ACCEA4B-811C-47CA-89FDEA13709B0AE©id=12A3AE3C-5B8D-473E-838B-7743A5262B81. Accessed February 24, 2009.

Snow V, Barry P, Fihn SD, Gibbons RJ, Owens DK, Williams SV, Mottur-Pilson C, Weiss KB; American College of Physicians; American College of Cardiology Chronic Stable Angina Panel. 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 Oct 5;141(7):562-7. Erratum in: Ann Intern Med. 2005 Jan 4;142(1):79.

Speyer JL, Green MD, Kramer E, et al. Protective effect of the bispiperazinedione ICRF-187 against doxorubicininduced cardiac toxicity in women with advanced breast cancer. N Engl J Med. 1988;319(12):745-752.

Voest EE, Vreugdenhil G, Marx JJM. Iron-chelating agents in non-iron overload conditions. Ann Intern Med.


Vogel J, Bolling S, Costello R, et al. Integrating Complementary Medicine Into Cardiovascular Medicine: A Report of the American College of Cardiology Foundation Task Force on Clinical Expert Consensus Documents (Writing Committee to Develop an Expert Consensus Document on Complementary and Integrative Medicine). Journal of the

American College of Cardiology. Vol. 46, No. 1, 2005. Available at:

http://www.acc.org/qualityandscience/clinical/consensus/complementary/index.pdf. Accessed March 13, 2009.

Walshe JM, Yealland M. Chelation treatment of neurological Wilson's disease. Q J Med. 1993;86(3):197-204.

History/Updates Policy update with additional indications added to coverage rationale. HCPCS codes J3490, J3520 and 4/10/2009 diagnosis codes added. Policy 2008T0051E archived.

Policy revision with changes to coverage rationale. CMS information updated. Policy 2007T0051D 12/1/2008 archived.

Policy updated and renamed Chelation Therapy. CMS information updated. Policy 2003T0051C archived.

4/12/2007 HCPCS code S9355 added to Coding Section per direction from the Reimbursement Medical Policy 7/12/2004 Operations Manager.

Medicare entry CIM 35-64 8/21/2003 Policy Updated. Tittle enhanced to include "and Other Indications."

6/19/2003 Policy Reformatted 2/26/2002 Contact Information For questions regarding this policy, send an email to the Medical Technology Interpretation Service at medical_drug_interpretation@uhc.com with the word "Medical" in the subject line.

Coding Chelation Therapy - Commercial Medical Management Guideline The Current Procedural Terminology (CPT) codes and HCPCS codes listed in this policy are for reference purposes only.

Listing of a service code in this policy does not imply that the service described by this code is a covered or non-covered health service. Coverage is determined by the benefit document.

HCPCS Codes:

J0470 Injection, dimercaprol, per 100 mg J0600 Injection, edetate calcium disodium, up to 1000 mg J0895 Injection, deferoxamine mesylate, 500 mg J3490 Unclassified drugs 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

Diagnosis Codes:

961.1 Poisoning by arsenical anti-infectives 961.2 Poisoning by heavy metal anti-infectives 964.0 Poisoning by iron and its compounds 984.0 Toxic effect of inorganic lead compounds 984.1 Toxic effect of organic lead compounds 984.8 Toxic effect of other lead compounds 984.9 Toxic effect of unspecified lead compound 985.1 Toxic effect of arsenic and its compounds 985.2 Toxic effect of manganese and its compounds 985.3 Toxic effect of beryllium and its compounds 985.4 Toxic effect of antimony and its compounds 985.5 Toxic effect of cadmium and its compounds 985.8 Toxic effect of other specified metals This information is being distributed to you for personal reference. The information belongs to UnitedHealthcare and unauthorized copying, use and distribution are prohibited. This information is intended to serve only as a general reference resource regarding our Medical Policies and is not intended to address every aspect of a clinical situation.

Physicians and patients should not rely on these Medical Policies in making health care decisions. Physicians and patients must exercise their independent clinical discretion and judgment in determining care. The enrollee's specific benefit documents supercede these policies and are used to make coverage determinations. These Medical Policies are believed to be current as of the date noted.

Chelation Therapy - Commercial Medical Management Guideline Confidential and Proprietary, © UnitedHealthcare, Inc. 2009 Chelation Therapy - Commercial Medical Management Guideline TITLE: Cochlear Implants Authorized By: Medical Management Guideline Committee

Adoption Date: 06/29/09 Revision Date:

Disclaimer This medical management guideline represents the recommendation of the PacifiCare Medical Management Guideline (MMG) committee. It is based on the MMG committee's review of the available evidence as of the date of this medical management guideline.

This medical management guideline contains clinical practice and utilization criteria to assist professionals in PacifiCare’s medical management practice when making medical necessity determinations prior to, subsequent to, or concurrent with the provisions of health care services. This medical management guideline is intended to support consistent, appropriate medical necessity determinations, but it does not replace an individualized case-by-case review and medical necessity determination for each PacifiCare member.

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