ModifiedCentenePolicy CP PHAR.610

Sodium thiosulfate (Pedmark) coverage

Defines medical necessity criteria, dosing, and authorization rules for Pedmark (sodium thiosulfate) to reduce cisplatin-associated ototoxicity in pediatric patients; applies to Centene-affiliated health plans for Commercial, HIM, and Medicaid lines of business.

Policy Summary

PayerCentene

PolicySodium thiosulfate (Pedmark) coverage

Policy CodePolicy CP PHAR.610

Change TypeCommercial duration language added

Effective DateMar 1, 2023

Next Review Date

Key ActionObtain prior authorization and submit documentation (office notes, labs, weight and BSA) showing member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

For continued therapy, commercial approval duration was added: 6 months or to the member's renewal date, whichever is longer.

Age ≥1 mo & <18 yrFDA-indicated pediatric age range

6 monthsApproval duration (commercial)

J0208, J0209Listed HCPCS codes

12.5 g vialProduct availability

Coverage Criteria

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Initial Therapy

Covered when ALL of the following are met:

Initial Ototoxicity Prophylaxis: Diagnosis of localized, non-metastatic solid tumor(s)

Initial Ototoxicity Prophylaxis: Member will be treated with cisplatin chemotherapy

Initial Ototoxicity Prophylaxis: Age > 1 month and < 18 years

Initial Ototoxicity Prophylaxis: Prescribed by or in consultation with an oncologist

Initial Ototoxicity Prophylaxis: Dose does not exceed weight-based limits: for body weight <5 kg: 10 g/m2 per dose; 5 to 10 kg: 15 g/m2 per dose; >10 kg: 20 g/m2 per dose

Initial Ototoxicity Prophylaxis: Administered IV following cisplatin infusions 1 to 6 hours in duration

Safety/efficacy not established when administered after cisplatin infusions longer than 6 hours.

Continuation Therapy

Covered when ALL of the following are met:

Continued Therapy: Member is currently receiving Pedmark via the Centene benefit, or documentation supports member has received Pedmark for a covered indication for at least 30 days

Continued Therapy: Member is responding positively to therapy

Continued Therapy: Dose does not exceed weight-based limits: for body weight <5 kg: 10 g/m2 per dose; 5 to 10 kg: 15 g/m2 per dose; >10 kg: 20 g/m2 per dose

Non‑FDA approved indications for Pedmark (sodium thiosulfate) are not authorized under this policy unless the provider submits sufficient documentation that demonstrates efficacy and safety in accordance with the plan’s off‑label use policies. For Commercial lines follow CP.CPA.09, for Health Insurance Marketplace follow HIM.PA.154, and for Medicaid follow CP.PMN.53, or provide applicable evidence of coverage documents that explicitly permit the requested use.

Pedmark is contraindicated in patients with a history of severe hypersensitivity to sodium thiosulfate or any of its components. Requests for therapy should be denied when documentation shows such a history.

When state Medicaid coverage provisions conflict with this clinical policy, state Medicaid provisions take precedence. Refer to the applicable state Medicaid manual for specific coverage rules and follow those state provisions when they differ from this policy.

Use of Pedmark for indications that are not FDA‑approved and not addressed by this policy is considered not authorized / not medically necessary unless the provider supplies adequate supporting evidence per the applicable off‑label use policies (CP.CPA.09 for Commercial, HIM.PA.154 for Marketplace, CP.PMN.53 for Medicaid) or the member’s evidence of coverage allows the use.

Coding

HCPCS Codes referencedHCPCS

J0209	Injection, sodium thiosulfate (Pedmark) 100 mg
J0208	Injection, sodium thiosulfate (Hope) 100 mg

HCPCS Codes referencedHCPCS

J0208	Injection, sodium thiosulfate (Pedmark) 100 mg.
J0209	Injection, sodium thiosulfate (Hope) 100 mg

Dosing thresholds by weight — per-dose limits

<5 kg per-dose threshold10 g/m2 per dose

5 to 10 kg per-dose threshold15 g/m2 per dose

>10 kg per-dose threshold20 g/m2 per dose

Continued therapy duration (Commercial)

Commercial continued therapy duration6 months or to the member's renewal date, whichever is longer

Medicaid/HIM continued therapy duration12 months

Minimum exposure required for continuationMember has received Pedmark for a covered indication for ≥30 days or is currently receiving via Centene benefit

Provider Actions and Billing

Prior Authorization

Prior Authorization Required

Prior authorization is required for Pedmark (sodium thiosulfate). Provider must obtain prior authorization before initiating therapy; Pedmark is considered medically necessary only when Centene clinical criteria are met.

Prior authorization required when criteria in this policy are satisfied
Pedmark medically necessary only if Centene criteria are met

Billing Rule

HCPCS Coding for Authorization and Claims

Submit claims using the HCPCS codes referenced below. Codes are provided for billing guidance only and do not guarantee coverage. Providers should verify coding with the most current professional coding resources prior to claim submission.

HCPCS: J0208 — Injection, sodium thiosulfate (Pedmark) 100 mg
HCPCS: J0209 — Injection, sodium thiosulfate 100 mg

Billing Rule

Coding Inclusion Note

Inclusion or exclusion of codes in this policy does not guarantee coverage or correct coding. Providers are responsible for applying current professional coding guidance and payer billing rules when submitting claims.

Codes listed are informational only and subject to change
Reference current CPT/HCPCS guidance and payer-specific instructions

Documentation Required

Required Documentation

Providers must submit supporting documentation with the prior authorization request. Incomplete requests may be delayed or denied.

Office chart notes documenting diagnosis and indication
Documentation of planned cisplatin chemotherapy
Member weight (kg) and body surface area (m2)
Evidence of prescriber specialty (oncologist) or consultation
Relevant laboratory results and dosing calculations

Note

Coverage and Documentation Reminder

Coverage determinations are based on the member's benefit documents and applicable state and federal rules. This policy provides clinical guidance but does not guarantee payment; decisions remain subject to the member's coverage terms and Health Plan administrative policies.

Coverage subject to evidence of coverage, certificate of coverage, policy contract, and state/federal requirements
Health Plan may change, amend, or withdraw this policy consistent with applicable law

Note

Refer to Formulary / Off‑Label Policies

If the requested use is addressed by formulary, non-formulary, or off‑label policies (e.g., new label changes or unlisted indications), refer to the appropriate policy for the member's line of business prior to prior authorization.

Formulary/non‑formulary and off‑label policies: CP.CPA.190, HIM.PA.33, CP.PMN.255 (formulary/non‑coverage); CP.CPA.09, HIM.PA.154, CP.PMN.53 (off‑label)
For non‑formulary drugs, refer to CP.CPA.190, HIM.PA.103, CP.PMN.16 as applicable

Initial Therapy Criteria

Initial Therapy

Covered when ALL of the following are met:

Initial Ototoxicity Prophylaxis: Diagnosis of localized, non-metastatic solid tumor(s)

Initial Ototoxicity Prophylaxis: Member will be treated with cisplatin chemotherapy

Initial Ototoxicity Prophylaxis: Age > 1 month and < 18 years

Initial Ototoxicity Prophylaxis: Prescribed by or in consultation with an oncologist

Initial Ototoxicity Prophylaxis: Dose does not exceed weight-based limits: for body weight <5 kg: 10 g/m2 per dose; 5 to 10 kg: 15 g/m2 per dose; >10 kg: 20 g/m2 per dose

Administered IV following cisplatin infusions 1 to 6 hours in duration.

Step Therapy

Step	Requirement	Action / Referral
1	If the requested use (diagnosis, age, dosing regimen) is listed in this policy, follow the policy-specific authorization criteria.	Proceed with prior authorization per Centene policy; include required documentation (diagnosis, weight, BSA, oncologist involvement, dosing).
2	If the requested use is not listed or a recent label change occurred within the last 6 months that is not reflected in this policy, refer to applicable formulary/off-label or non-formulary policies per line of business before authorization.	For drugs on formulary/PDL: follow the No Coverage Criteria or Off‑Label use policy for the relevant line of business (e.g., CP.CPA.190, CP CPA.09, HIM.PA.33/ HIM.PA.154, CP PMN.255/ CP.PMN.53).
3	If the drug is not on the formulary/PDL and the requested use is not covered by this policy, refer to the non‑formulary policy for the relevant line of business before proceeding.	Follow the non‑formulary policy for the relevant line of business (e.g., CP.CPA.190/ HIM.PA.103/ CP PMN.16) to determine prior authorization or coverage options.

OpenPayer

Sodium thiosulfate (Pedmark) coverage

Coverage Criteria

Coding

Provider Actions and Billing

Initial Therapy Criteria

Continuation Therapy Criteria

Step Therapy

Site of Care

Background

Definitions