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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. 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.

01-99000-07

Original Effective Date: 08/15/01

Reviewed: 04/24/14

Revised: 11/01/15

Subject: Chelation Therapy

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
           
Other References Updates    
           

DESCRIPTION:

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. For example, deferoxamine is used for individuals with iron toxicity, and calcium-ethylenediaminetetraacetic acid (EDTA) is used for individuals with lead poisoning. Note that 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 the disequilibrium of cerebral metals. Chelation therapy has also been discussed as a treatment for other indications including atherosclerosis and autism. For example, EDTA chelation therapy has been proposed in individuals with atherosclerosis as a method of decreasing obstruction in the arteries.

Whole blood lead levels are considered a more specific and sensitive means of testing for lead toxicity. Urine tests for lead levels assess the plasma lead concentration and are not considered accurate measurements of blood lead levels because of rapid fluctuation in plasma lead, as compared to whole blood lead levels.

A diagnostic workup for metal toxicity must include the history, an appropriate choice of tests and testing methods, and the use of accurate and specific reference values. With regard to urine testing, the use of chelation therapy to treat heavy metal poisoning 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.

POSITION STATEMENT:

 

Certificate of Medical Necessity

Submit a completed Certificate of Medical Necessity (CMN) along with your request to expedite the medical review process.

1. Click the link Chelation Therapy - Certificate of Medical Necessity (MS Word) to open the form.

2. Complete all fields on the form thoroughly.

3. Print and submit a copy of the form with your request.

Note: Florida Blue regularly updates CMNs. Ensure you are using the most current copy of a CMN before submitting to Florida Blue. For a complete list of available CMNs, visit the Certificates of Medical Necessity page.

Chelation therapy meets the definition of medical necessity when administered for the treatment of the following:

*NOTE: The use of chelation therapy to treat heavy metal toxicity based on post-challenge (post-provoked) urine testing does not meet the definition of medical necessity.

Chelation therapy is considered experimental or investigational, as there is insufficient scientific evidence to support the use of chelation therapy for all other indications, and specifically for the following conditions:

BILLING/CODING INFORMATION:

The following codes may be used to describe chelation therapy.

HCPCS Coding:

J0470

Injection, dimercaprol, per 100 mg

J0600

Injection, edetate calcium disodium, up to 1000 mg

J0895

Injection, deferoxamine mesylate, 500 mg

J3520

Edetate disodium, per 150 mg (Endrate, EDTA)

M0300

IV chelation therapy (chemical endarterectomy)

ICD-10 Diagnosis Codes That Support Medical Necessity forJ0470, J0600, J0895, and J3520: (Effective 10/01/15)

D46.Z

Other myeolodysplastic syndromes

D46.9

Myelodysplastic syndrome, unspecified

D56.0 – D56.9

Thalassemia

D57.40

Sickle-cell thalassemia without crisis

D57.411 – D57.419

Sickle-cell thalassemia with acute chest syndrome; with splenic sequestration; with crisis, unspecified

D64.0 – D64.4

Other anemias

E83.00 – E83.09

Disorders of copper metabolism

E83.10 – E83.19

Disorders of iron metabolism

E83.52

Hypercalcemia

T37.8x1A – T37.96xS

Poisoning by, adverse effect of and underdosing of other specified systemic anti-infectives and anti-parasitics

T45.4x1A – T45.4x6S

Poisoning by, adverse effect of and underdosing of iron and its compounds

T56.0x1A – T56.0x4S

Toxic effects of lead and its compounds

T56.1x1A – T56.1x4S

Toxic effect of mercury and its compounds

T56.3x1A – T56.3x4S

Toxic effect of cadmium and its compounds

T57.0x1A – T57.0x4S

Toxic effect of arsenic and its compounds

REIMBURSEMENT INFORMATION:

Refer to sections entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products:

The following National Coverage Determinations (NCDs) were reviewed on the last guideline reviewed date: Chelation Therapy (20.21) and Chelation Therapy (20.22), located at cms.gov.

The following Local Coverage Determination (LCD) was reviewed on the last guideline reviewed date: Chelation Therapy (L33809), located at fcso.com.

DEFINITIONS:

Primary hemochromatosis: iron overload caused by a genetic defect 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: iron overload which is usually the result of another condition or disease that causes the overabundance of iron; may include anemias, chronic liver diseases, and the requirement of blood transfusions.

Wilson’s disease: abnormal processing of copper in the body, causing copper accumulation.

RELATED GUIDELINES:

None applicable.

OTHER:

None applicable.

REFERENCES:

  1. American Academy of Pediatrics Policy Statement. Lead Exposure in Children: Prevention, Detection, and Management. Pediatrics 2005; 116; 1036-1046. Accessed 06/06/07.
  2. American Academy of Pediatrics. Treatment Guidelines for Lead Exposure in Children. PEDIATRICS Vol. 116 No. 4 October 2005, pp. 1036-1046 (DOI: 10.1542/peds. 2005 – 1947). Accessed 06/06/07.
  3. American Cancer Society; Alternative and Complementary Therapies: Chelation Therapy, (accessed 07/18/08).
  4. American College of Cardiology Position Statement. Chelation Therapy: ACCF Complementary Medicine Expert Consensus Document: “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.
  5. American Heart Association, Recommendation for Chelation Therapy, (accessed 06/16/08).
  6. American Medical Association CPT, (current edition).
  7. Blue Cross Blue Shield Association. Medical Policy Reference Manual. Chelation Therapy 8.01.02 Chelation Therapy. (June 2013).
  8. Centers for Medicare and Medicaid Services (CMS) National Coverage Determination Chelation Therapy for Treatment of Artherosclerosis, Publication 100-3, Section 20.21 (no posted effective date).
  9. Centers for Medicare and Medicaid Services (CMS) National Coverage Determination, EDTA Chelation Therapy for Treatment of Atherosclerosis, Publication 100-3, Section 20.22 (no posted effective date).
  10. Charlton N, Wallace KL. American College of Medical Toxicology Position Statement on Post-Chelator Challenge Urinary Metal Testing (2009). Accessed at http://www.acmt.net on 04/01/14.
  11. Chen KH, 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):530-538.
  12. ClinicalTrials.gov. Trial to Access Chelation Therapy (TACT). Information provided by National Heart, Lung, and Blood Institute (NHLBI). Identifier NCT00044213. (Accessed 08/03/09).
  13. Crinnion WJ. The benefits of pre- and post-challenge urine heavy metal testing: Part 1. Altern Med Rev. 2009 Mar;14(1):3-8.
  14. Crinnion WJ. The benefit of pre- and post-challenge urine heavy metal testing: Part 2. Altern Med Rev. 2009 Jun;14(2):103-8.
  15. First Coast Service Options (Medicare), Local Coverage Determination #L6020, Chelation Therapy, (10/01/06). Retired 02/01/09.
  16. Florida Medicare Part B Local Coverage Determination #L29098. Chelation Therapy. (02/13/11).
  17. First Coast Service Options, Inc. (FCSO). Local Coverage Determination L33809. Chelation Therapy (10/01/14).
  18. HAYES, Inc. Medical Technology Directory. Chelation Therapy, Non-Overload Conditions. Lansdale, PA. Hayes, Inc.; (10/05/04; updated 11/04/07).
  19. HAYES, Inc. Medical Technology Directory: Chelation Therapy, Overload Conditions. Lansdale, PA. Hayes, Inc.; (02/28/03; updated 03/27/08).
  20. Ho G, et al. Blood, Urine, and Hair Kinetic Analysis Following an Acute Lead Intoxication. Journal of Analytical Toxicology, Vol. 35, January/February 2011.
  21. Qaseem A, 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. Ann Intern Med. 2012;157:735-743.
  22. Sampson E, Jenagaratnam L, McShane R. Metal protein attenuating compounds for the treatment of Alzheimer's disease. Cochrane Database of Systematic Reviews 2008, Issue 1. Art. No.: CD005380. DOI: 10.1002/14651858.CD005380.pub3.
  23. Smith HJ, Meremikwu M. ”Iron chelating agents for treating malaria”; a review published in The Cochrane Library 2007, Issue 2.
  24. St. Anthony’s ICD-9-CM Code Book, (current edition).
  25. Villarruz MV, Dans A, Tan F. “Chelation therapy for atherosclerotic cardiovascular disease”; a review published in The Cochrane Library 2006, Issue 2.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 04/24/14.

GUIDELINE UPDATE INFORMATION:

08/15/01

Medical Coverage Guideline Reformatted.

09/15/02

Reviewed; references updated. Added Program Exception for Medicare and More.

10/15/03

Reviewed; add iron overload as a covered diagnosis.

07/15/04

Scheduled review; no changes.

08/15/05

Scheduled review; no change in coverage statement.

08/15/06

Scheduled review; revise coverage statement regarding acute iron intoxication and chronic iron overload.

11/15/06

Revision consisting of adding clarification statement regarding testing for lead toxicity.

07/15/07

Scheduled review; added ICD-9 code to Program Exception for Medicare Advantage products; reformatted guideline; updated references.

09/15/08

Scheduled review; no change in position statement. Update references.

09/15/09

Scheduled review; no change in position statement. Update references.

10/01/10

4th Quarter HCPCS coding update: ICD-9 diagnosis code 275.0 deleted; ICD-9 diagnosis codes 275.01, 275.02, 275.03 and 275.09 added.

10/15/10

Revision; related ICD-10 codes added; Medicare Exception ICD-9 coding section updated with the addition of ICD-9 codes 275.01 – 275.09 for CPT code J0895.

10/01/11

Revision; added ICD9 codes 282.43, 282.44 and 282.45.

05/15/14

Unscheduled review. Revised MCG title, description section, position statement, ICD9 and ICD10 coding, program exceptions and definitions. Updated references.

10/01/15

Revision consisting of update to Program Exceptions section.

11/01/15

Revision: ICD-9 Codes deleted.

Date Printed: August 18, 2017: 10:28 AM