CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Chelation Therapy for Off-Label Uses

Defines Blue Cross & Blue Shield of Rhode Island's coverage stance for chelation therapy when used for off-label indications (eg, Alzheimer disease, arthritis, atherosclerosis, autism spectrum disorder, diabetes, multiple sclerosis) for Commercial Products; excludes FDA-approved indications and provides billing/coding notes.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyChelation Therapy for Off-Label Uses

Policy CodePolicy N/A

Change TypeClarified applicability to Commercial Products; directed Medicare Advantage to related policy section

Effective DateJan 1, 2017

Next Review Date

Key ActionCode drugs and nursing visits separately; S9355 represents the infusion service only and is not separately reimbursed.

SourceLink

POLICY UPDATE CHANGES

Policy applicable to Commercial Products only; Medicare Advantage Plans directed to related policy section.

6Off-label indications listed as not medically necessary

7FDA-approved indications noted (policy does not address)

Coverage Summary

This policy defines Blue Cross & Blue Shield of Rhode Island's coverage stance for chelation therapy when used for off-label indications for Commercial Products: chelation therapy for non–FDA-approved uses is not covered (not medically necessary). The policy is effective 01/01/2017 and was last reviewed on 03/20/2024. It excludes FDA‑approved indications (which remain standard of care) and directs Medicare Advantage plans to related policy guidance.

Surface quick policy facts

Effective Date2017-01-01

Last Review2024-03-20

StatusCURRENT

SubjectChelation therapy for off-label uses

Commercial Products scopeDefines BCBSRI's coverage stance for chelation therapy when used for off-label indications (eg, Alzheimer disease, arthritis, atherosclerosis, autism spectrum disorder, diabetes, multiple sclerosis); excludes FDA‑approved indications and provides billing/coding notes.

Policy position summaryNot medically necessary for listed off-label indications (6 listed).

Medical Necessity / Not Medically Necessary Criteria

Commercial Products - Off-label applications

Off-label applications of chelation therapy (non-FDA-approved uses) are considered not medically necessary when used for the following indications:

Not medically necessary for listed off-label indications

Alzheimer disease
Arthritis (includes rheumatoid arthritis)
Atherosclerosis (eg, coronary artery disease, secondary prevention in individuals with myocardial infarction, or peripheral vascular disease)
Autism Spectrum Disorder
Diabetes
Multiple Sclerosis

FDA-approved indications (policy not addressing these)

This policy does not address the following FDA-approved indications for which chelation therapy is considered standard of care treatment (informational):

Control of ventricular arrhythmias or heart block associated with digitalis toxicity
Emergency treatment of hypercalcemia
Extreme conditions of metal toxicity
Lead Poisoning
Treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) or due to non-transfusion-dependent thalassemia (NTDT)

Chemical Endarterectomy

HCPCS code and medications utilized as part of the service are not medically necessary when filed with the listed ICD-10 diagnosis codes:

Chemical Endarterectomy - not medically necessary when filed with listed diagnoses: HCPCS M0300 IV chelation therapy (chemical endarterectomy) is not medically necessary when filed with the listed ICD-10 diagnosis codes: E08.00-E13.9, F84.0-F84.9, G30.0-G30.9, G35, I25.10-I25.9, M05.00-M06.09, M15.0-M19.93

Failure to report Chemical Endarterectomy using M0300 will be considered improper coding by Blue Cross & Blue Shield of Rhode Island.

Coding

Infusion service - represented HCPCS (not separately reimbursed)HCPCS

S9355

Home Infusion Therapy, chelation therapy; administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment (drugs and nursing visits coded separately), per diem

Chemical Endarterectomy - not medically necessary when filed with listed diagnosesHCPCS|ICD-10Not Covered

M0300	IV chelation therapy (chemical endarterectomy)
E08.00-E13.9	Diabetes mellitus codes range
F84.0-F84.9	Pervasive developmental disorders (includes autism spectrum disorder)
G30.0-G30.9	Alzheimer disease codes range
G35	Multiple sclerosis
I25.10-I25.9	Chronic ischemic heart disease (atherosclerotic disease range)
M05.00-M06.09	Rheumatoid arthritis codes range
M15.0-M19.93	Osteoarthritis and other arthropathies codes range

Provider Actions & Billing Rules

Billing Rule

Infusion service reimbursement

HCPCS S9355 represents the infusion service only and is not separately reimbursed; drugs and nursing visits should be coded separately.

Affected code: S9355
Note: S9355 represents infusion service only and is not separately reimbursed; drugs and nursing visits must be coded separately.

Documentation Required

Chemical Endarterectomy coding requirement

Failure of participating providers to report Chemical Endarterectomy using M0300 will be considered improper coding by Blue Cross & Blue Shield of Rhode Island.

Affected code: M0300
Admonition: Not reporting M0300 for Chemical Endarterectomy will be considered improper coding.

Background & Evidence Summary

Chelation therapy is an established treatment for heavy metal toxicities and for removal of iron in transfusional hemosiderosis; specific agents (eg, deferoxamine, EDTA) are used for particular metal toxicities. Investigational or off‑label uses include Alzheimer disease, atherosclerosis (including post‑myocardial infarction secondary prevention), autism spectrum disorder, diabetes, multiple sclerosis, and various forms of arthritis. Randomized trials and case series for these off‑label indications are insufficient to demonstrate a net health benefit. Notably, the Trial to Assess Chelation Therapy (TACT) reported a reduction in cardiovascular events among patients with prior myocardial infarction, with greater apparent benefit in patients with diabetes, but the trial had significant limitations (for example, high dropout rates) that limit definitive conclusions. Systematic reviews and available RCTs for other conditions did not show improvements in health outcomes, and case series are inadequate to establish efficacy.

Definitions

Chelation therapyIntravenous or oral administration of chelating agents that remove metal ions (eg, lead, aluminum, mercury, arsenic, zinc, iron, copper, calcium) from the body.

MPACsMetal protein attenuating compounds under investigation for Alzheimer disease that modulate metal homeostasis rather than systemic removal.

Name	NCD Number	Type
CHELATION THERAPY for Treatment of Atherosclerosis	20.21	NCD
Ethylenediamine-Tetra-Acetic (EDTA) CHELATION THERAPY for Treatment of Atherosclerosis	20.22	NCD