Mountain State Medical Policy Bulletin
Section: Injections
Number: I-5
Topic: Chelation Therapy/Chemical Endarterectomy
Effective Date: March 27, 2006
Issued Date: September 10, 2007
Date Last Reviewed: 06/2007

General Policy Guidelines

Indications and Limitations of Coverage

Chelation Therapy
When the Edetate Calcium Disodium (J0600) is reported for chelation therapy for heavy metal poisoning (961.1, 961.2, 964.0, 984.0, 984.1, 984.8, 984.9, 985.1, 985.5, and 985.8) or Wilson's disease (275.1) (hepatolenticular degeneration), is reported, coverage for treatment is determined according to individual or group customer benefits.

Chelation therapy is also eligible for the treatment of the following conditions:

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

The agent used for chelation therapy (J0600) should be denied as not covered when used to treat conditions other than those referenced above.

Chemical Endarterectomy
Use of Edetate Disodium (J3520) in the treatment of atherosclerosis, arteriosclerosis, or any other condition is considered experimental/investigational and, therefore, is not covered.  These are not FDA approved indications and scientific evidence does not demonstrate that safety and efficacy have been proven. A participating, preferred, or network provider can bill the member for the denied service.

M0300 represents either the intravenous administration of the chelating agent or the intravenous administration of EDTA (J3520).

When the chemical endarterectomy is not covered, all related services are also not covered (e.g., E/M, lab work, infusion services, administration [M0300], etc.).

When the administration code M0300 is billed with procedure code J3520 it will be denied as experimental/investigational. A participating, preferred, or network provider can bill the member for the denied service.

Description

Chelation Therapy
Chelation therapy is the treatment of choice for heavy metal poisoning.  The treatment consists of the intravenous administration (M0300) of chelating agents (e.g., Edetate Calcium Disodium (J0600), Endrate) to promote excretion of the offending metal.  Treatment may also include medical care.

Chemical Endarterectomy
Chemical endarterectomy is a form of treatment used for the removal of plaque or calcium.  It consists of the intravenous administration (M0300) of Edetate Disodium - EDTA (J3520) for conditions such as atherosclerosis, arteriosclerosis, or similar generalized conditions.


NOTE:
This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Procedure Codes

J0600J3520M0300   

Traditional Guidelines

Refer to General Policy Guidelines

FEP Guidelines

The medical necessity guidelines are applied pre-payment for FEP.

PPO Guidelines

Refer to General Policy Guidelines

Managed Care POS Guidelines

Refer to General Policy Guidelines

Publications

References

Chelation Therapy for Coronary Heart Disease: An Overview of All Clinical Investigations, American Heart Journal, Vol. 140, No. 1, 07/2000

Chelation Therapy for Ischemic Heart Disease, A Randomized Controlled Trial, Journal of the American Medical Association, Vol. 287, 01/2002

Edetate Calcium Disodium, USPDI - Vol. I, Edition 21, 2001 Micromedex, Inc.

Deaths Associated with Hypocalcemia from Chelation Therapy, Texas, Pennsylvania, and Oregon, 2003-2005, The Journal of American Medical Association, Vol. 295, No. 18, 05/2006

NIH Launches Large Clinical Trial on EDTA Chelation Therapy for Coronary Artery Disease, NIH News Release, National Institute of Health, Released 8/7/2002

View Previous Versions

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[Version 003 of I-5]
[Version 002 of I-5]
[Version 001 of I-5]

Table Attachment

Text Attachment

Procedure Code Attachment


Glossary




This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Medical policies are designed to supplement the terms of a member's contract. The member's contract defines the benefits available; therefore, medical policies should not be construed as overriding specific contract language. In the event of conflict, the contract shall govern.

Medical policies do not constitute medical advice, nor the practice of medicine. Rather, such policies are intended only to establish general guidelines for coverage and reimbursement under Mountain State Blue Cross Blue Shield plans. Application of a medical policy to determine coverage in an individual instance is not intended and shall not be construed to supercede the professional judgment of a treating provider. In all situations, the treating provider must use his/her professional judgment to provide care he/she believes to be in the best interest of the patient, and the provider and patient remain responsible for all treatment decisions.

Mountain State Blue Cross Blue Shield (MSBCBS) retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of MSBCBS. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.