Local Coverage Determination
Chelation Therapy (L29098)
Effective Date: February 13, 2011
Indications and Limitations of Coverage and/or Medical Necessity
Chelation therapy is the administration of chelating agents to remove heavy metals from the body. The chelation therapy agents can be covered for the Food and Drug Administration (FDA) approved indication(s) and associated condition(s) as outlined. Chelation therapy is performed in cases of iron, lead, copper, and aluminum overload when the patient has the associated disorder and in certain specific cases of heavy metal toxicities.
It can be medically necessary when clinically indicated for diseases/disorders such as cystinuria; secondary hematochromatosis (due to iron overload from multiple transfusions), and Wilson's disease. It can be medically necessary for heavy metal poisoning (such as arsenic, cadmium, copper, gold, iron, lead, and mercury) when the patient has specific signs and symptoms of heavy metal toxicity and/or a history of likely exposure to heavy metals with standard of care laboratory confirmation.
It is expected that any patient receiving chelation therapy has documented laboratory evidence of heavy metal toxicity with standard of care testing for the suspected heavy metal. For example, testing of whole blood level is the most sensitive and specific means in assessing lead toxicity. Urinary lead level is not an accurate measure of blood lead levels. Provoked testing for lead and mercury levels are not clinically appropriate. Also, any non standard of care testing of patients who demonstrate only vague, ill-defined symptoms with no history of likely heavy metal exposure for heavy metal toxicity is screening, and therefore, the testing is not a covered service as well as the chelation therapy.
Dimercaprol (BAL) (procedure code J0470):
Dimercaprol (BAL) is a useful antidote in arsenic, mercury, lead, and cadmium poisoning and is most efficient if administered immediately following exposure to the metals. Dimercaprol is administered intramuscularly.
Edetate Calcium Disodium (Calcium EDTA) (procedure code J0600):
For the purposes of this LCD, the only EDTA indicated for use as a chelating agent is Calcium Disodium Versenate (procedure code J0600)
Edetate Calcium Disodium (Calcium EDTA) is a useful antidote in lead poisoning and lead encephalopathy. Calcium EDTA is administered intravenously, subcutaneously or intramuscularly with the intramuscular route preferred. The diagnosis of lead toxicity depends on the testing of whole blood lead levels. Urinary lead level is not an accurate measure of blood lead levels and does not substantiate the medical necessity of chelation therapy.
- Edetate Disodium (procedure code J3520), also known as Endrate, EDTA, is not covered for use as a chelating agent.
- EDTA Used as a Treatment and Prevention of Atherosclerosis is not covered.
- The application of chelation therapy using ethylenediamine-tetra-acetic acid (EDTA) for the treatment and prevention of atherosclerosis is controversial. There is no widely accepted rationale to explain the beneficial effects attributed to this therapy. Its safety is questioned and its clinical effectiveness has never been established by well designed, controlled clinical trials. It is not widely accepted and practiced by American physicians. EDTA chelation therapy for atherosclerosis is considered experimental. For these reasons, EDTA chelation therapy for the treatment or prevention of atherosclerosis is not covered.
- EDTA Used as a Mobilization Test (Provocative Chelation) is not covered.
- The administration of the chelating agent calcium EDTA as a mobilization test (provocative chelation) to determine if chelation therapy is indicated is controversial. The provocative chelation test was developed to assess the total body lead burden and efficacy of chelation treatment. The tests involve obtaining a urine collection after administering a dose of calcium EDTA. In view of a paucity of relevant clinical outcomes for studies of provocative chelation, and in view of animal studies suggesting that single doses of chelation might cause harm from mobilizing lead and redistributing it to the central nervous system, the use of provocative chelation is not indicated and therefore is not covered.
Deferoxamine Mesylate (Desferal) (procedure code J0895):
Deferoxamine mesylate (Desferal) is the chelator of choice for iron poisoning. Deferoxamine is most effective when administered intramuscularly or intravenously.
Desferal is indicated for the treatment of acute iron intoxication and of chronic iron overload due to transfusion-dependent anemias. ICD-9 code 275.01-275.09 must be used for those patients with secondary iron overload from multiple transfusions who do not meet the definition for ICD-9 code 285.0 (Sideroblastic anemia).
Note: Per the FDA circular, Desferal is specifically not indicated for the treatment of primary hematochromatosis. Phlebotomy is the treatment of choice for this condition and the patient's medical record would need clear support for any off-label use of chelation therapy in lieu of phlebotomy.
Chelation therapy is not covered for a myriad of alternative medicine uses that are not medically necessary and reasonable for treatment of an illness or injury since treatment outcomes have not been consistently demonstrated as well as the diagnostic criteria for treatment. Examples of clinical situations where chelation therapy is not covered since heavy metal toxicity is not clinically apparent and not consistent with standards of diagnostic testing (this is not an all inclusive list) are as follows: the prevention and treatment of cancer, cardiovascular disease (CAD), peripheral vascular disease, individuals at risk from drug-eluting stents, neurodegenerative diseases (such as Alzheimer's disease), autism, attention deficit hyperactivity disorder, fungal disease, progressive renal insufficiency in Type II diabetic nephropathy, Parkinson's disease, and hypercholesterolemia.
CMS National Coverage Policy:
Language quoted from CMS National Coverage Determinations (NCDs) and coverage provisions in interpretive manuals are italicized throughout the Local Coverage Determination (LCD). NCDs and coverage provisions in interpretive manuals are not subject to the LCD Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See §1869(f)(1)(A)(i) of the Social Security Act.
Unless otherwise specified, italicized text represents quotation from one or more of the following CMS sources:
CMS Manual System, Pub. 100-03, Chapter 1, Section 20.21-20.22
Medical record documentation maintained by the ordering/referring physician or the nonphysical practitioner must substantiate the medical need for the use of these drugs by clearly indicating the condition for which the drug is being used. The medical record must indicate that the treatment is based on diagnostic information, including the appropriate laboratory testing (such as whole blood for lead toxicity), completed to confirm the need to remove unwanted metal ions from the body for the treatment of metal intoxication. In addition, specific signs and symptoms of heavy metal poisoning must be documented to substantiate that the Food and Drug Administration (FDA) indications for chelating drug usage is followed. Documentation that the service was performed must also be included in the patient's medical record. This documentation is usually found in the history and physical or in the office/progress notes of the medical record.
It is expected that these services would be performed as indicated by current literature and/or standards of practice and should follow the guidelines for administration and safety found in the FDA approved labels for these drugs. When services are performed in excess of established parameters, they may be subject to medical review for medical necessity.
LCD Determination ID: J0470
Original Determination Effective Date: 2009-02-02
Latest Revision Effective Date: 2011-02-13
Why This Determination Was Made
The above determination was made after government officials realized that Medicare billings for chelation therapy were far more frequent in Florida than anywhere else in the United States. The following notice appeared on page 80 of the March 2011 Medicare B Update:
This report was posted on October 26, 2012.