| MP 8.01.02 | Chelation Therapy | |
| Medical Policy | ||
| Section Therapy |
Original Policy Date 12/1/95 |
Last Review Status/Date Reviewed by consensus/12:2008 |
| Issue 12:2008 |
Return to Medical Policy Index |
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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, desferoxamine is used for patients with iron toxicity and calcium-EDTA is used for patients with lead poisoning. Disodium- EDTA is not recommended for acute lead poisoning due to the increased risk of death from hypocalcemia .(1) 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, and autism.
Policy
Chelation therapy may be considered medically necessary in the treatment of each of the following conditions:
- Control of ventricular arrhythmias or heart block associated with digitalis toxicity;
- Emergency treatment of hypercalcemia;
- Extreme conditions of metal toxicity
- treatment of chronic iron overload fue to blood transfusions (transfusional hemosiderosis)
- Wilson's disease (hepatolenticular degeneration); and
- Lead poisoning.
Other applications of chelation therapy are considered investigational, including, but not limited to:
- atherosclerosis (i.e., coronary artery disease or peripheral vascular disease)
- multiple sclerosis;
- arthritis;
- hypoglycemia;
- autism
- Alzheimer's disease;
- diabetes
Policy Guidelines
No applicable information
Benefit Application
BlueCard/National Account Issues
No applicable information
Rationale
Chelation therapy is an established treatment for the medically necessary indications listed here, particularly for the treatment of metal toxicity (i.e., lead, iron, copper). However, its use in other indications has been controversial, particularly its use in the treatment of atherosclerosis and autism.
Atherosclerosis
The American College of Cardiology Foundation’s (ACCF) complementary medicine expert consensus document (2) states that:
“At present, the benefit of chelation therapy remains controversial as highlighted by a recent Cochrane Review [3] of five randomized controlled studies in small numbers of subjects evaluating outcomes of disease severity and subjective measures of improvement..”
This position statement was originally adopted by the ACC in 1985 and reapproved in 1990. A search of the MEDLINE database for the period of 1995 to September 2008 did not identify any studies that would change the policy determination for atherosclerosis. Specifically, in 2002, Knudtson and colleagues published the results of a placebo-controlled, double-blind clinical trial that randomized 84 patients with coronary artery disease and a positive treadmill test to receive EDTA chelation therapy or placebo, 3 hours per treatment twice weekly for 15 weeks, and once per month for an additional 3 months. (4) The main outcome measures included change in time to ischemia, functional reserve for exercise, and quality of life. There was no significant difference between the 2 groups. Another double-blind, randomized control study of EDTA chelation or placebo showed no change in short- or long-term improvement in vasomotor response to EDTA when compared to placebo. (5) Two small randomized trials have also reported no benefit of chelation therapy as a treatment of peripheral arterial disease. (6, 7) Other published studies consist primarily of case reports and case series. (8, 9) In 2002, a Cochrane review of the efficacy of chelation therapy in peripheral vascular disease (referenced in the ACCF statement) concluded that, “…studies published to date have failed to demonstrate significant benefit with the use of EDTA chelation therapy in people with peripheral vascular disease” (2).
In 2003, the National Heart, Lung, and Blood Institute, in collaboration with the National Center for Complementary and Alternative Medicine, sponsored the “Trial to Assess Chelation Therapy” (TACT; ClinicalTrials.gov Identifier NCT00044213) to study the use of chelation in atherosclerosis. TACT began recruiting 2,400 patients randomized to either placebo or chelation therapy. The primary outcomes include a composite of cardiovascular morbidity and all-cause mortality. The study is set for completion in July 2010.
Autism
Based on similarities between mercury poisoning and autism spectrum disorder symptoms, Bernard and colleagues hypothesized a link between environmental mercury and autism. (10) This theory was rejected by Nelson and colleagues, who found that many of the characteristics of mercury poisoning such as ataxia, constricted visual fields, peripheral neuropathy, hypertension, skin eruption, and thrombocytopenia, are never seen in autistic children. (11) In 2007, a systematic review by Ng and colleagues demonstrated no association between mercury poisoning and autism. (12)
In 2006, the National Institute of Mental Health (NIMH) sponsored the “Mercury Chelation to Treat Autism” trial (ClinicalTrials.gov Identifier NCT00376194). This trial was designed to randomly assign 120 children between the ages of 4 and 10 years with autism spectrum disorder and “who have detectable, but not toxic, levels of mercury or lead in the blood” to either placebo or chelation therapy. The trial was halted in 2007. The NIMH determined that there was no clear evidence for direct benefit to the children who would participate in the chelation trial and that the therapy presented more than a minimal risk. (13)
Other Indications
The literature search did not identify any articles that focused on the use of chelation therapy for multiple sclerosis, Alzheimer’s disease, arthritis, hypoglycemia, or diabetes.
References:
- Centers for Disease Control and Prevention (CDC). Deaths associated with hypocalcemia from chelation therapy--Texas, Pennsylvania, and Oregon, 2003-2005. MMWR Morb Mortal Wkly Rep 2006; 55(8):204-7.
- Vogel JH, Bolling SF, Costello RB et al. Integrating complementary medicine into cardiovascular medicine. A report of the American College of Cardiology Foundation TaskForce on Clinical Expert Consensus Documents (Writing Committee to Develop an Expert Consensus Document on Complementary and Integrative Medicine). J Am Coll Cardiol 2005; 46:184-221.
- Villarruz MV, Dans A, Tan F. Chelation therapy for atherosclerotic cardiovascular disease. Cochrane Database Syst Rev 2002; 4:CD002785
- Knudtson ML, Wyse DG, Galbraith PD et al. Chelation therapy for ischemic heart disease: a randomized controlled trial. JAMA 2002; 287(4):481-6.
- 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):420-5.
- Guldager B, Jelnes R, Jorgensen SJ et al. EDTA treatment of intermittent claudication--a double-blind placebo-controlled study. J Intern Med 1992; 231(3):261-7.
- Van Rij AM, Solomon C, Packer SG et al. Chelation therapy for intermittent claudication. A double-blind, randomized, controlled trial. Circulation 1994; 90(3):1194-9.
- Ernst E. Chelation therapy for coronary heart disease: an overview of all clinical investigations. Am Heart J 2000; 140(1):139-41.
- Ernst E. Chelation therapy for peripheral arterial occlusive disease: a systematic review. Circulation 1997; 96(3):1031-3.
- Bernard S, Enayati A, Redwood L et al. Autism: a novel form of mercury poisoning. Med Hypotheses 2001; 56(4):462-71.
- Nelson KB, Bauman ML. Thimerosal and autism? Pediatrics 2003; 111(3):674-9.
- Ng DK, Chan CH, Soo MT et al. Low-level chronic mercury exposure in children and adolescents: meta-analysis. Pediatr Int 2007; 49(1):80-7.
- Stokstad E. Medicine. Stalled trial for autism highlights dilemma of alternative treatments. Science 2008; 321(5887):326.
|
Codes |
Number |
Description |
| CPT | 96365 | Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); initial, up to 1 hour (code renumbered effective 1/1/09 - previous code number was 90765) |
| 96366 | each additional hour (list separately in addition to code for primary procedure) (code renumbered effective 1/1/09 - previous code number was 90766) | |
| 96374 | Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); intravenous push, single or initial substance/drug (code renumbered effective 1/1/09 - previous code number was 90774.) | |
| ICD-9 Procedure | 99.16 | Injection of antidote (heavy metal antagonist) |
| ICD-9 Diagnosis | 275.1 | Wilson’s disease (hypercupremia) |
| 275.4 | Hypercalcemia | |
| 282.4 | Thalassemia intermedia | |
| 427.9 | Arrhythmia | |
| 984–984.9 | Lead poisoning code range | |
| 440 | Atherosclerosis (code range) | |
| 999.8 | Other infusion and trasnfusion reaction not elsewhere classified | |
| HCPCS | M0300 | IV chelation therapy (chemical endarterectomy) |
| J0470 | Injection, dimercaprol, per 100 mg | |
| J0600 | Injection, edetate calcium disodium, up to 1000 mg | |
| J3520 | Edetate disodium, per 150 mg | |
| Type of Service | Injection | |
| Place of Service | Inpatient | |
Index
Chelation therapy
Chemical endarterectomy
Policy History
| Date | Action | Reason |
| 12/1/95 | Add to Surgery section | New policy |
| 07/12/02 | Replace policy | Policy reviewed; policy statement unchanged, rationale, references added |
| 10/09/03 | Replace policy | Policy reviewed by consensus without literature review; no changes in policy; no further review scheduled |
| 12/14/05 | Replace policy – coding update only | CPT coding updated |
| 12/11/08 | Replace policy | Policy returned to “active review” status. Policy updated with literature review; policy statements revised to indicate that chelation therapy may be considered medically necessary in the treatment of iron overload due to transfusional hemosiderosis and considered investigational in the treatment of autism and Alzheimer’s disease. Other policy statements are unchanged. Reference numbers 1-3,5, 10-13 added |
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