CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Medical Coverage Policy | Chelation Therapy for Off-Label Uses

Defines Blue Cross Blue Shield Rhode Island's coverage position for chelation therapy when used for off-label (non-FDA-approved) indications in Commercial Products, lists excluded/standard FDA-approved indications, coding guidance including a non-reimbursable infusion code and a Chemical Endarterectomy code with related diagnosis exclusions.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyMedical Coverage Policy | Chelation Therapy for Off-Label Uses

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 1, 2017

Next Review Date

Key ActionVerify member benefits and coverage for chelation therapy via the applicable Benefit Booklet, Evidence of Coverage, or Subscriber Agreement as benefits may vary between groups and contracts.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes.

6Off-label Indications Listed as Not Medically Necessary

7FDA-Approved/Standard Indications Listed

Coverage Summary

Defines Blue Cross Blue Shield Rhode Island's coverage position for chelation therapy when used for off-label (non-FDA-approved) indications in Commercial Products. Off-label applications of chelation therapy for the following conditions are considered not medically necessary: Alzheimer disease; Atherosclerotic cardiovascular disease; Arthritis (including rheumatoid arthritis); Autism spectrum disorder; Diabetes; Multiple sclerosis.

This policy does not address FDA-approved / standard-of-care indications for chelation therapy (examples include extreme metal toxicity; chronic iron overload due to transfusions or NTDT; Wilson disease; lead poisoning; control of ventricular arrhythmias/heart block from digitalis toxicity; emergency treatment of hypercalcemia).

Coding and billing guidance: S9355 represents the infusion service only and is not separately reimbursed for drugs and nursing visits; M0300 IV chelation therapy (chemical endarterectomy) and associated medications are not medically necessary when filed with specified diagnosis codes (see policy).

Effective date: 2017-01-01; Policy last review: 2021-04-07; Status: CURRENT.

Key statistics

SubjectChelation therapy for off-label uses

Coverage stancenot_covered_cosmetic

Off-label indications listed as not medically necessary6

FDA-Approved/Standard indications listed7

Effective date2017-01-01

Last review2021-04-07

Medical Necessity Criteria

Not Medically Necessary — Off-label Indications

Off‑label applications of chelation therapy (non‑FDA‑approved uses) are considered not medically necessary as the evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

ANY of the following

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

FDA-Approved / Standard of Care Indications (Not addressed by this policy)

The following indications are FDA‑approved or considered standard of care and are not addressed by this off‑label chelation therapy policy.

ANY of the following

Extreme conditions of metal toxicity
Treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) or due to non‑transfusion‑dependent thalassemia (NTDT)
Wilson disease (hepatolenticular degeneration)
Lead poisoning
Control of ventricular arrhythmias or heart block associated with digitalis toxicity

Chemical Endarterectomy (M0300) — Not Medically Necessary with Listed Diagnoses

The following code and any medications utilized as part of the service are not medically necessary when filed with any of the listed ICD‑10 diagnosis codes. Failure of participating providers to report Chemical Endarterectomy using M0300 will be considered improper coding by BCBSRI.

ALL of the following

Procedure code: M0300 — IV chelation therapy (chemical endarterectomy)
The procedure code represents the chemical endarterectomy service; medications used as part of the service are also considered not medically necessary when billed with the diagnoses below.
ANY of the following
- E08.00-E13.9 — Diabetes mellitus code range
- F84.0-F84.9 — Autism spectrum disorders
- G30.0-G30.9 — Alzheimer's disease code range

Coding

ICD-10 Diagnosis Ranges Associated with Not Medically Necessary Chemical EndarterectomyICD-10Not Covered

E08.00-E13.9	Diabetes mellitus code range
F84.0-F84.9	Autism spectrum disorders
G30.0-G30.9	Alzheimer's disease code range
G35	Multiple sclerosis
I25.10-I25.9	Atherosclerosis code range
M05.00-M06.09	Rheumatoid arthritis code range
M15.0-M19.93	Osteoarthritis code range

Provider Actions / Billing Guidance

Documentation Required

Reference Benefit Documents

Verify member benefits and coverage for chelation therapy via the applicable Benefit Booklet, Evidence of Coverage, or Subscriber Agreement as benefits may vary between groups and contracts.

Billing Rule

Chemical Endarterectomy Coding Requirement

Failure of participating providers to report Chemical Endarterectomy using M0300 will be considered improper coding by BCBSRI.

M0300

Billing Rule

Infusion Service Billing

S9355 represents the infusion service only and is not separately reimbursed for drugs and nursing visits which must be coded separately.

S9355

Background & Evidence

Chelation therapy is an established treatment for removal of metal toxins and for transfusional iron overload using specific chelating agents; it removes metal ions (eg, lead, aluminum, mercury, arsenic, zinc, iron, copper, calcium) and converts them to excretable forms.

Metal protein attenuating compounds (MPACs) have been investigated as a potential treatment for Alzheimer disease because they modulate cerebral metal homeostasis and may promote solubilization and clearance of beta amyloid; however, no MPACs are FDA-approved for Alzheimer disease.

For the listed off-label indications (Alzheimer disease, cardiovascular disease including atherosclerosis, autism spectrum disorder, diabetes, multiple sclerosis, arthritis), evidence from randomized controlled trials and case series is insufficient to demonstrate improved net health outcomes; therefore these off-label uses are considered not medically necessary. Additionally, M0300 (chemical endarterectomy) and associated medications are not medically necessary when filed with specified diagnosis codes.

Evidence summary

RCTs / Trials referencedTrial to Assess Chelation Therapy (TACT) reported reduced cardiovascular events in post-MI patients with greater benefit in diabetic patients but had limitations; other RCTs did not show improvements for other conditions.

Other evidence typesSmall number of RCTs and case series; case series inadequate to determine efficacy

Definitions available2 definitions (see Definitions section)

Codes notedM0300 chemical endarterectomy listed as not medically necessary with specified diagnoses; S9355 represents infusion service only

Definitions

Off-label: Use of chelation therapy for indications not approved by the FDA.

Chemical Endarterectomy (M0300): IV chelation therapy procedure code referenced by BCBSRI; considered not medically necessary when filed with the listed diagnosis codes.

Medicare National Coverage Determinations

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

Revision History

2017-01-01Effective

Policy effective date

2021-04-07Last reviewLatest

Policy last updated

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyMedical Coverage Policy | Chelation Therapy for Off-Label Uses

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 1, 2017

Next Review Date

SourceLink

On This Page

Emergency treatment of hypercalcemia

G35 — Multiple sclerosis

I25.10-I25.9 — Atherosclerosis code range

M05.00-M06.09 — Rheumatoid arthritis code range

M15.0-M19.93 — Osteoarthritis code range