CHELATION THERAPY THE801.008 POSTED DATE: 6/11/2003 EFFECTIVE DATE: 8/15/2003 ______

COVERAGE:

Chelation Therapy is considered medically necessary when used in the treatment of the following conditions:

• Control of ventricular arrhythmias or heart block associated with digitalis toxicity and electrolyte imbalance; • Emergency treatment of hypercalcemia; • Conditions of heavy metal toxicity, including but not limited to: * thalassemia intermedia (hereditary group of hemolytic anemias) with hemosiderosis(increase in tissue iron stores); * Wilson’s Disease (hepatolenticular degeneration - inherited copper toxicosis); and * Lead, arsenic or mercury poisoning.

Chelation therapy is considered experimental or investigational in the treatment of the following diseases: • Multiple Sclerosis; • Arthritis; • Hypoglycemia; • Peripheral vascular disease of the legs (intermittent claudication); • Diabetes; • Arteriosclerotic Heart Disease; • Any other condition not listed above. ______DESCRIPTION:

Chelation Therapy consists of the administration of chelating agents which remove toxic metals ions from the body. These agents may be administered orally, intravenously (IV), intramuscularly (IM), or subcutaneously (SQ), depending on the agent used. Examples of agents used include:

• Deferoxamine, • Dimercaprol, • Edetate Disodium (EDTA), • Deferoxamine Mesylate, • Edetate Calcium Disodium, or • Succimer (DMSA) ______RATIONALE:

The continued occurrence of lead overexposure and lead poisoning remains a serious problem despite awareness of its adverse health effects. Lead exposure is a particularly insidious hazard with the potential for causing irreversible health effects, including hypotension, central nervous system problems, anemia and diminished hearing acuity before it is clinically recognized. Scientific evidence Blue Cross and Blue Shield of Texas, a Division of Health Care Service Corporation, a Mutual Legal Reserve Company* Southwest Texas HMO, Inc.* d/b/a HMO Blue Texas * Independent Licensees of the Blue Cross and Blue Shield Association

CHELATION THERAPY THE801.008 POSTED DATE: 6/11/2003 EFFECTIVE DATE: 8/15/2003 ______of subclinical lead toxicity continues to accumulate, making further reduction in exposure, regular screening, and earlier diagnosis and treatment of critical importance. In October 1991, the Centers for Disease Control issued new recommendations lowering the acceptable blood lead level. This change was based on data indicating that irreversible adverse neurodevelopmental effects occur in children with chronic low-level exposure to lead. The primary source of lead poisoning is still lead-based paint, especially in older urban housing. Almost all U.S. children are considered at risk of lead poisoning and should be screened.

Chelation therapy can have short-term benefits; however these benefits must be accompanied by drastic reduction in environmental exposure to lead if therapy is to have any long-term benefit. The decision to initiate chelation therapy is not based on specific blood levels but depends on the severity of the clinical symptoms.

Oral chelation therapy on an outpatient basis is now available to treat less severe cases of lead poisoning. ______PRICING:

None ______REFERENCES:

• “Occupational lead poisoning”, American Family Physician, February 15, 1998, 57(4): 719-26, 731-2. • “Lead poisoning in children”, American Family Physician, January 1993, 47(1): 113-20. • “Evaluation of the potential role of chelation therapy in treatment of low to moderate lead exposures”, Environmental Health Perspective, November 1990, 89:67-74. • “Iron chelating agents in non-iron overload conditions”, Annals of Internal Medicine, March 15, 1994, 120(6): 490-9. • "Elimination of Poisons" The Merck Manual, Seventeenth Edition, 1999, pages, 2622-2623, 2636. • Cada, Dennis J., Pharm D., et al. Of the Editorial Advisory Panel. 2002 “Dimercaprol.”Drugs, Facts and Comparisons, St. Louis, Facts and Comparison, A Wolters Kluwer Company, (2002 February): 377 “Deferoxamine Mesylate”, page 378 “Edetate Calcium Disodium (Calcium EDTA)”, page 378-379 • “Dangers of Lead Still Linger”, U.S. Food and Drug Administration, FDA/CFSAN FDA Consumer, (web site 02-15-2002) http://www.cfsan.fda.gov/~dms/fdalead.html. • U.S. Food and Drug Administration, Product: Succimer (trade name Chemet), http:/www.fda.gov/Orphan/GRANTS/magrants.htm, (web site 02- 15-2002) • “Chelation Therapy”, BCBSA Uniform Medical Policy Reference Manual, Blue Cross and Blue Shield of Texas, a Division of Health Care Service Corporation, a Mutual Legal Reserve Company* Southwest Texas HMO, Inc.* d/b/a HMO Blue Texas * Independent Licensees of the Blue Cross and Blue Shield Association

CHELATION THERAPY THE801.008 POSTED DATE: 6/11/2003 EFFECTIVE DATE: 8/15/2003 ______

(1995 December 1) Therapy: 8.01.02 • "Chelation Therapy", AHA Recommendation, American Heart Association.org, (web site 05/06/2002) ______DISCLAIMER:

State and federal law, as well as contract language, including definitions and specific inclusions/exclusions, takes precedence over Medical Policy and must be considered first in determining coverage. The member’s contract benefits in effect on the date that services are rendered must be used. Any benefits are subject to the payment of premiums for the date on which services are rendered. Medical technology is constantly evolving, and we reserve the right to review and update Medical Policy periodically. HMO Blue Texas physicians who are contracted/affiliated with a capitated IPA/medical group must contact the IPA/medical group for information regarding HMO claims/reimbursement information and other general polices and procedures.

Blue Cross and Blue Shield of Texas, a Division of Health Care Service Corporation, a Mutual Legal Reserve Company* Southwest Texas HMO, Inc.* d/b/a HMO Blue Texas * Independent Licensees of the Blue Cross and Blue Shield Association