CurrentUnitedHealthcarePolicy CSO16TN.N

Chelation Therapy (for Tennessee Only)

Policy governs coverage of chelation therapy for TennCare Medicaid and CoverKids members in Tennessee, including applicable codes, FDA guidance, and references to TennCare exclusion rules.

Policy Summary

PayerUnitedHealthcare

PolicyChelation Therapy (for Tennessee Only)

Policy CodePolicy CSO16TN.N

Change TypeTitle revisedsupersedes CSO16TN.M

Effective DateAug 1, 2025

Next Review Date

Key ActionObtain and verify prior authorization and coverage per applicable federal, state, or contractual TennCare requirements before providing chelation therapy.

SourceLink

POLICY UPDATE CHANGES

Title changed from 'Chelation Therapy for Non-Overload Conditions (for Tennessee Only)' to current title and FDA section updated.

2025-08-01policy effective date

1200-13-13-.10referenced exclusion rule

1TOC pages

Coverage Criteria

Coverage contingent on TennCare Medical Necessity

Covered only when consistent with TennCare Medicaid medical necessity rules and FDA-approved indications.

TennCare Conformity: Coverage requires that services meet TennCare Medicaid Chapter 1200-13-13-.10 medical necessity criteria and any applicable federal, state, or contractual requirements.

Refer to TennCare Chapter 1200-13-13-.10 for specific exclusions and clinical criteria.

Coverage for chelation therapy under this policy is limited to FDA‑approved indications and is covered only when consistent with TennCare Medicaid medical necessity rules (TennCare Chapter 1200‑13‑13‑.10). The list of procedure and drug codes in the policy is provided for reference and does not by itself guarantee coverage or payment; benefit determination and any prior authorization requirements are governed by applicable federal, state, or contractual requirements.

The use of chelating agents to treat or cure autism is not an FDA‑approved indication and is explicitly not supported by FDA guidance. FDA communications warn that chelating agents are approved for specific uses such as treatment of lead poisoning and iron overload and are not approved as a therapy for autism or autism‑related symptoms.

Coding and Indications

Policy Summary

PayerUnitedHealthcare

PolicyChelation Therapy (for Tennessee Only)

Policy CodePolicy CSO16TN.N

Change TypeTitle revisedsupersedes CSO16TN.M

Effective DateAug 1, 2025

Next Review Date

Key ActionObtain and verify prior authorization and coverage per applicable federal, state, or contractual TennCare requirements before providing chelation therapy.

SourceLink

On This Page

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Referenced Procedure/Drug CodesHCPCS

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.
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

FDA‑approved indications — use limited to FDA‑approved indications for each chelation agent

Coverage limitationUse limited to FDA-approved indications for each chelation agent as referenced in a generally recognized drug compendium (e.g., AHFS, DrugDex).

Permitted indications (examples)Treatment of metal poisoning (e.g., lead) and treatment of iron overload, when consistent with FDA labeling.

Reference guidanceFDA states chelating agents are approved for specific uses and are available by prescription only; not approved to treat or cure autism.

Documentation noteFDA approval is informational only for this policy; coverage depends on meeting TennCare medical necessity and applicable plan/state rules.

Provider Actions and Billing

Prior Authorization

Provider Responsibilities and Prior Authorization

Prior authorization and coverage are determined by applicable federal, state, or contractual requirements. Providers must check the member's plan and applicable regulatory rules (for example, TennCare) to confirm whether prior authorization is required before providing services.

Prior authorization and coverage determined by plan/state rules — confirm with member’s specific benefit plan and state regulations.
Providers must reference federal, state, or contractual requirements when deciding coverage; this policy is informational and does not replace plan-specific rules.
Services (including procedure and diagnosis codes listed in this policy) may be excluded per TennCare Medicaid Chapter 1200-13-.13-.10; listing of a code does not guarantee coverage or payment.

Billing Rule

Provider Action and Billing

Before billing, verify prior authorization requirements and coverage limitations with the payer and the member’s benefit plan. Documentation of medical necessity and applicable authorizations should be maintained to support claims.

Action: Check member-specific plan documents and state program rules (e.g., TennCare) for prior authorization and coverage details.
Action: Retain clinical documentation and any prior authorization approvals to support claims and appeals.
Note: Inclusion of a code in this policy does not imply coverage or guarantee payment.

Note

Reference Requirements

This policy is informational. Providers must follow federal, state, and contractual plan terms where they differ from this policy. In the event of a conflict, the federal, state, or contractual requirements govern.

Policy is informational — verify and follow the specific benefit plan and regulatory requirements before providing services.
UnitedHealthcare may modify policies; always confirm current requirements prior to treatment and billing.

Denial Risk

Exclusions and Code Listing Notice

Certain services may be excluded under TennCare Medicaid Chapter 1200-13-.13-.10. The lists of procedure and diagnosis codes provided in this policy are for reference only and are not exhaustive. Inclusion of a code does not guarantee coverage or payment.

Providers should confirm whether specific codes or services are excluded under TennCare or other applicable state programs.
The presence of a code in this policy does not establish eligibility for reimbursement; coverage decisions are subject to plan and regulatory requirements.

OpenPayer

Chelation Therapy (for Tennessee Only)

Coverage Criteria

Coding and Indications

Provider Actions and Billing

Background

Definitions