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DESCRIPTIONWithin the human body, the presence of certain heavy metals such as iron and copper, in the proper concentrations is essential for normal bodily functions. Other heavy metals such as lead and aluminum are nonessential. The build-up of heavy metals in the body, which can occur through ingestion or from a metabolic dysfunction, is toxic. 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, desferoxamine is used for patients with iron toxicity, and calcium-EDTA (ethylenediaminetetraacetic acid) is used for patients with lead poisoning. Note that disodium- EDTA is not recommended for acute lead poisoning due to the increased risk of death from hypocalcemia. Disodium-EDTA has been discontinued by the U.S. Food and Drug Administration (FDA).
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 Aβ-amyloid protein by binding its metal-ion complex, and also inhibit redox reactions that generate neurotoxic free radicals. MPACs therefore interrupt two putative pathogenic processes of Alzheimer’s disease. However, no MPACs have received FDA approval for the treatment of Alzheimer’s disease.
While chelation therapy has been used effectively in patients with heavy metal toxicities, chelation therapy has been proposed for other therapeutic indications, including atherosclerosis, rheumatoid arthritis, Alzheimer’s disease, and autism.
POLICYChelation therapy is considered medically necessary when based on blood levels and used to treat the following:
Other applications of chelation therapy are considered investigational, including, but not limited to:
Investigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY5/2000: Approved by Medical Policy Advisory Committee (MPAC)
5/23/2001: Code reference section revised, ICD-9 diagnosis code 174.0-174.9, 175.0-175.9, 198.1, 233.0, 909.5, 973.0 added covered codes, non-covered table added, ICD-9 diagnosis code 250.0X-250.9X, 251.0-251.3, 331.0, 340, 390-459.9, 714.0-714.9, 716.9X, 998.89 added non-covered codes
2/14/2002: Investigational definition added
4/18/2002: Type of Service and Place of Service deleted
11/4/2004: Code Reference section updated, ICD-9 diagnosis code 174.0-174.9, 175.0-175.9, 198.1, 233.0 deleted covered codes, ICD-9 diagnosis 790.6, 796.0, 961.2, 985.8 added covered codes, ICD-9 diagnosis 973.0 description revised covered codes, non-covered table deleted, ICD-9 diagnosis code 250.0X-250.9X, 251.0-251.3, 331.0, 340, 390-459.9, 714.0-714.9, 716.9X, 998.
1/6/2009: Policy reviewed, policy section re-written for clarity
06/22/2010: Policy description updated regarding available chelating agents. Reworded the policy statement regarding Wilson’s disease. Added “includes rheumatoid arthritis” to the investigational policy statement for arthritis, and added autism as an investigational application. Deleted outdated references from the Sources section. Added ICD-9 code 275.42.
10/14/2010: Annual ICD-9 code update: 275.0 deleted/expanded to the fifth digit. Added 275.02 and 275.09 to the Covered Codes table.
06/22/2011: Policy reviewed; no changes.
05/09/2012: Policy reviewed; no changes.
05/07/2013: Removed deleted ICD-9 diagnosis code 275.0 from the Code Reference section. Also deleted 275.09 from the Code Reference section. Added 985.0 and 985.1 to the Code Reference section.
11/15/2013: Added treatment of chronic iron overload due to nontransfusion-dependent thalassemia (NDTD) as a medically necessary condition. Investigational statement on atherosclerosis updated to include coronary artery disease, secondary prevention in patients with myocardial infarction, or peripheral vascular disease.
SOURCE(S)Blue Cross Blue Shield association policy #8.01.02
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.