CurrentUnitedHealthcarePolicy CS016TN.N

Chelation Therapy (for Tennessee Only)

Policy governing the use of chelation therapy for Tennessee Medicaid and CoverKids members, referencing TennCare exclusions for medical necessity and FDA guidance; applies to providers billing Medicaid/CoverKids in Tennessee.

Policy Summary

PayerUnitedHealthcare

PolicyChelation Therapy (for Tennessee Only)

Policy CodePolicy CS016TN.N

Change TypeClarified FDA sectionrevised title

Effective DateAug 1, 2025

Next Review Date

Key ActionRefer to TennCare Medicaid Chapter 1200-13-13-.10 for medical necessity and prior authorization requirements.

SourceLink

POLICY UPDATE CHANGES

Title changed from 'Chelation Therapy for Non-Overload Conditions (for Tennessee Only)' to 'Chelation Therapy (for Tennessee Only)'.

Updated FDA section to reflect the most current information.

2025-08-01Effective date

TNPolicy applies to state

7Named billing codes listed for reference

TennCare 1200-13-13-.10Referenced medical necessity/exclusions source

Coverage and Medical Necessity Criteria

Policy Summary

PayerUnitedHealthcare

PolicyChelation Therapy (for Tennessee Only)

Policy CodePolicy CS016TN.N

Change TypeClarified FDA sectionrevised title

Effective DateAug 1, 2025

Next Review Date

Key ActionRefer to TennCare Medicaid Chapter 1200-13-13-.10 for medical necessity and prior authorization requirements.

SourceLink

On This Page

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Medical necessity per TennCare

Covered when consistent with TennCare medical necessity rules

TennCare medical necessity: Services are subject to TennCare Medicaid Chapter 1200-13-13-.10 exclusions and medical necessity criteria; refer to that source for specific coverage rules.

Policy defers to state rule for criteria

FDA-indicated uses — Covered when ALL of the following are met

Covered when ALL of the following are met

FDA-approved indications: Chelation therapy using FDA-approved chelating agents is approved and limited to treatment of metal poisoning or iron overload per FDA-approved indications and recognized drug compendia.

Use limited to indications in drug compendia such as AHFS or DrugDex

Chelation therapy used to treat or cure autism or autism-related symptoms is not an FDA-approved indication and is excluded. Refer to the TennCare Medicaid Chapter 1200-13-13-.10 for state-specific medical necessity rules and exclusions that govern coverage decisions.

The FDA has stated that chelating agents are approved for specific indications such as the treatment of lead poisoning and iron overload and are available by prescription only. In 2019 the FDA warned against companies making improper claims that their products treat or cure autism; therefore use of chelation for autism or autism-related symptoms is not considered medically necessary per FDA guidance.

Procedure and Diagnosis Codes

Referenced procedure/drug codesmixed

J0470	Injection, dimercaprol, per 100 mg.
J0600	Injection, edetate calcium disodium, up to 1,000 mg.
J0895	Injection, deferoxamine mesylate, 500 mg.
J3490	Unclassified drugs.
J3520	Edetate disodium, per 150 mg.
J8499	Prescription drug, oral, nonchemotherapeutic, NOS.
M0300	IV chelation therapy (chemical endarterectomy).
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

Coding thresholds and notes

Thresholds specifiedNone specified in this policy

ImplicationNo numeric or utilization thresholds (e.g., dose limits, frequency) are defined; coverage governed by state medical necessity rules and FDA indications

Codes listed for referenceProcedure and drug codes are listed elsewhere in the policy for reference; listing does not imply coverage or authorization

Provider Responsibilities and Authorization

Prior Authorization

Prior Authorization Required

Refer to TennCare Medicaid Chapter 1200-13-13-.10 for prior authorization requirements and exclusions. Providers must obtain any required prior authorization from TennCare/UnitedHealthcare before initiating chelation-related services to avoid claim denials.

Affected/commonly-referenced HCPCS/CPT codes (for reference only): J0470, J0600, J0895, J3490, J3520, J8499, M0300, S9355

Documentation Required

Documentation Requirements

Providers must submit complete clinical documentation supporting medical necessity with each prior authorization and claim. Documentation should include diagnosis, relevant clinical history, prior treatments and responses, indication for chelation therapy (if claimed), drug name(s), dose, frequency, route, and anticipated duration of therapy.

Incomplete or missing documentation may result in claim denial or delayed processing.
Listing of codes in this policy does not guarantee coverage or reimbursement.

Denial Risk

Denial Risk — Exclusions and Triggers

Services that are excluded under TennCare Chapter 1200-13-13-.10 (see Coverage Rationale) or otherwise not authorized may be denied. Providers should verify member eligibility, benefit coverage, and any state-mandated exclusions prior to service delivery.

Denial triggers include: services listed as exclusions in TennCare Chapter 1200-13-13-.10; lack of prior authorization when required; insufficient clinical documentation; use of unlisted/unapproved drugs without justification.

Note

Provider Action — Validate Authorization and Documentation

Action required: Providers must obtain prior authorization when TennCare requires it, include the supporting clinical documentation described above, and bill using the appropriate HCPCS/CPT codes. Remember that code inclusion here is for reference only and does not assure coverage or payment.

Confirm prior authorization requirements with TennCare/UnitedHealthcare before scheduling services.
Ensure claims list drug HCPCS (e.g., J0470, J0600, J0895, J3520, J8499) and procedure codes (e.g., M0300, S9355) as appropriate, with supporting documentation.

Definitions and Regulatory Notes

Chelation therapy (definition and scope)

DefinitionUse of chelating agents approved by the FDA to bind metals for treatment of metal poisoning or iron overload; use is limited to FDA-approved indications as referenced in recognized drug compendia (e.g., AHFS, DrugDex)

Indication limitCovered only when used for metal poisoning or iron overload per FDA-approved indications

Reference sourcesInstructions for Use drug compendia such as American Hospital Formulary Services Drug Information or DrugDex and FDA electronic resources

Coverage noteFDA approval alone is informational; coverage decisions are determined by federal, state, or contractual requirements (see TennCare Chapter 1200-13-13-.10)

Improper claims and FDA warning

FDA warning (2019)In 2019 the FDA warned companies for making improper claims that chelation agents treat or cure autism; FDA-approved chelating agents are not approved for autism treatment

Approved usesFDA-approved chelating agents are approved for specific uses such as treatment of lead poisoning and iron overload and are available by prescription only

Consumer informationAdditional FDA consumer information is available at FDA press releases and consumer-update pages referenced in the policy

OpenPayer

Chelation Therapy (for Tennessee Only)

Coverage and Medical Necessity Criteria

Procedure and Diagnosis Codes

Provider Responsibilities and Authorization

Background and Context

Definitions and Regulatory Notes

Policy Revision History