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    v1.0.28
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsSecurity Health Pedmark Prior Auth | OpenPayer
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    CurrentSecurity Health Plan of Wisconsin, Inc.Policy IC-0679

    Pedmark (sodium thiosulfate) Intravenous Therapy

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    This policy governs prior authorization, dosing, initial coverage, renewal, administration, and billing for intravenous Pedmark used to reduce cisplatin-associated ototoxicity, primarily in pediatric patients with localized, non-metastatic solid tumors.

    Policy Summary
    PayerSecurity Health Plan of Wisconsin, Inc.
    PolicyPedmark (sodium thiosulfate) Intravenous Therapy
    Policy CodePolicy IC-0679
    Change TypeNo material change
    Effective DateN/A
    Last ReviewJul 1, 2025
    Next Review DateN/A
    Key ActionObtain prior authorization; initial approval is valid for 12 weeks (84 days), with renewal available in additional 12-week periods.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    12 weeksPrior authorization validity
    500 unitsMaximum dose every 14 days
    1 month to <18Covered patient age range
    145 mmol/LMaximum serum sodium

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    Coverage Criteria

    Initial Therapy

    Covered when ALL of the universal and indication-specific criteria are met.

    Initial approval

    • Universal criterion: The patient does not have a serum sodium level greater than 145 mmol/L (145 mEq/L).≤145 mmol/L (145 mEq/L)

    • Cisplatin ototoxicity-prevention indication

      • The patient is at least 1 month of age and less than 18 years of age.≥1 month and <18 years
      • The patient has a localized, non-metastatic solid tumor.
      • The patient is receiving cisplatin infusions that are 1 to 6 hours in duration, and the next cisplatin infusion is scheduled to be in more than 10 hours.Infusion duration: 1–6 hours; next infusion: >10 hours later

    Continuation Therapy

    Coverage may be renewed when ALL renewal criteria are met.

    Renewal criteria

    • The patient continues to meet the universal and other relevant indication-specific criteria identified in the initial approval criteria, including applicable concomitant therapy requirements, performance status, and other relevant requirements.
    • The patient has no unacceptable toxicity from Pedmark (sodium thiosulfate).

      Examples of unacceptable toxicity include hypersensitivity reactions, hypernatremia, hypokalemia, and severe nausea/vomiting.

    • The patient continues to require chemoprotective treatment to counteract cisplatin ototoxicity.

    Exception for Other Uses

    Other uses are permitted only under the documented shortage exception.

    Shortage exception

    • For any other use of Pedmark, sodium thiosulfate 12.5 g/50 mL is not obtainable.Sodium thiosulfate 12.5 g/50 mL unavailable

      The shortage must be confirmed through the FDA Drug Shortage website.

    Other uses of Pedmark are not covered unless sodium thiosulfate 12.5 g/50 mL is unavailable and the shortage is confirmed through the FDA Drug Shortage website.

    Do not administer Pedmark when the next cisplatin infusion is scheduled to begin in less than 10 hours.

    Coding and Clinical Parameters

    Covered HCPCS CodesHCPCSCovered
    J0208Injection, sodium thiosulfate (pedmark), 100 mg; 1 billable unit = 100 mg
    NDC CodesNDC
    73077-0010-xxPedmark 12.5 gm/100 mL single-dose vial solution for injection
    Covered Diagnosis CodesICD-10Covered
    H91.01Ototoxic hearing loss, right ear.
    H91.02Ototoxic hearing loss, left ear.
    H91.03Ototoxic hearing loss, bilateral.
    H91.09Ototoxic hearing loss, unspecified.
    Serum sodium
    Maximum serum sodiumNot greater than 145 mmol/L (145 mEq/L)
    Coverage considerationCoverage may be denied when serum sodium is greater than 145 mmol/L (145 mEq/L).
    Criterion typeUniversal criterion for Pedmark coverage.
    Patient age
    Minimum ageAt least 1 month of age.
    Maximum ageLess than 18 years of age.
    Covered populationPatients from 1 month through less than 18 years of age receiving cisplatin for the covered indication.
    Cisplatin infusion duration
    Required durationCisplatin infusions must last 1 to 6 hours.
    Pedmark timingFor multiday cisplatin regimens, administer Pedmark 6 hours after completion of each cisplatin infusion.
    Timing relationshipPedmark administration must occur at least 10 hours before the next cisplatin infusion.
    Interval before next cisplatin infusion
    Required intervalThe next cisplatin infusion must be scheduled more than 10 hours later.
    Administration restrictionDo not administer Pedmark if the next cisplatin infusion is scheduled to begin in less than 10 hours.
    Minimum separationPedmark must be administered at least 10 hours before the next cisplatin infusion.
    Maximum dose quantity
    Maximum quantity500 billable units per 14-day period.
    Equivalent amount500 billable units equals 50 g.
    Billing basisThe limit applies to HCPCS units for cisplatin-induced ototoxicity prevention.

    Provider Actions and Denial Risks

    Prior Authorization

    12-Week Prior Authorization

    Prior authorization is required for Pedmark. Initial authorization is valid for 12 weeks (84 days), and renewal authorization may be granted every 12 weeks (84 days), unless otherwise specified, to correspond with the anticipated duration of cisplatin administration.

    Documentation Required

    Initial Clinical Documentation

    Submit documentation for initial authorization showing that the patient meets the universal and indication-specific criteria, including age, tumor characteristics, cisplatin infusion timing, and the planned chemoprotective treatment.

    • Patient is at least 1 month old and younger than 18 years.
    • Patient has a localized, non-metastatic solid tumor.
    • Patient is receiving cisplatin infusions lasting 1–6 hours, with the next cisplatin infusion scheduled more than 10 hours later.
    • Document that the patient’s serum sodium is not greater than 145 mmol/L (145 mEq/L).
    Documentation Required

    Renewal Documentation

    For renewal, document continued eligibility under the universal and indication-specific criteria, absence of unacceptable toxicity, and the ongoing need for chemoprotective treatment to counteract cisplatin-induced ototoxicity.

    • Confirm the patient continues to meet relevant criteria, including concomitant therapy requirements and other applicable treatment requirements.
    • Document absence of unacceptable toxicity, including hypersensitivity reactions, hypernatremia, hypokalemia, or severe nausea/vomiting.
    • Document that the patient continues to require chemoprotective treatment for cisplatin ototoxicity.

    Unsupported block type: documentation

    Denial Risk

    Hypernatremia Above Threshold

    Coverage may be denied when the patient’s serum sodium level is greater than 145 mmol/L (145 mEq/L).

    • Serum sodium must not exceed 145 mmol/L (145 mEq/L).
    Denial Risk

    Indication Criteria Not Met

    Coverage may be denied when the patient does not meet the required age, tumor, or cisplatin treatment criteria for reduction of cisplatin-associated ototoxicity risk.

    • Age must be at least 1 month and less than 18 years.
    • Tumor must be localized and non-metastatic.
    • Cisplatin infusions must last 1–6 hours, and the next infusion must be scheduled more than 10 hours later.
    Denial Risk

    Unapproved Use Requires Shortage Exception

    Any use outside the stated indication requires the documented shortage exception. Without evidence that sodium thiosulfate 12.5 g/50 mL is unavailable and that the FDA has confirmed the shortage, coverage may be denied.

    • Document product unavailability.
    • Provide FDA Drug Shortage website confirmation.
    Denial Risk

    Toxicity or No Ongoing Need

    Renewal may be denied if the patient develops unacceptable toxicity or no longer requires ongoing chemoprotective treatment for cisplatin ototoxicity.

    • Unacceptable toxicity includes hypersensitivity reactions, hypernatremia, hypokalemia, and severe nausea/vomiting.
    • Document continued need for chemoprotective treatment to counteract cisplatin ototoxicity.
    Billing Rule

    Dosing Limit Exceeded

    Claims exceeding the policy’s dosing limit may be denied or exceed the authorized quantity.

    • Maximum: 500 billable HCPCS units (50 g) every 14 days for cisplatin-induced ototoxicity prevention.

    Background

    Pedmark (sodium thiosulfate) is an intravenous chemoprotective treatment used to reduce the risk of cisplatin-induced ototoxicity. Coverage focuses on patients at least 1 month and less than 18 years of age with localized, non-metastatic solid tumors receiving cisplatin infusions lasting 1 to 6 hours. For multiday regimens, Pedmark is administered after cisplatin and must be given at least 10 hours before the next cisplatin infusion.

    Definitions

    Localized, non-metastatic solid tumor
    Tumor typeA solid tumor.
    LocalizationThe tumor is confined to its original site.
    Metastatic statusThere is no distant metastatic disease.
    Cisplatin infusion timing
    Cisplatin durationThe cisplatin infusion lasts 1 to 6 hours.
    Pedmark administrationAdminister Pedmark 6 hours after completion of each cisplatin infusion.
    Interval before next infusionAdminister Pedmark at least 10 hours before the next cisplatin infusion; do not administer it when the next infusion begins in less than 10 hours.

    Initial Therapy Criteria

    Cisplatin Ototoxicity Prevention

    Initial coverage is provided when ALL criteria are met.

    Initial Pedmark therapy

    • The patient does not have a serum sodium level greater than 145 mmol/L (145 mEq/L).≤145 mmol/L (145 mEq/L)
    • The patient is at least 1 month of age and less than 18 years of age.≥1 month and <18 years
    • The patient has a localized, non-metastatic solid tumor.
    • The patient is receiving cisplatin infusions that are 1 to 6 hours in duration, and the next cisplatin infusion is scheduled to be in more than 10 hours.Infusion duration: 1–6 hours; next infusion: >10 hours later

    Continuation Criteria

    Renewal

    Coverage may be renewed based on the following criteria.

    Continuation therapy

    • The patient continues to meet the universal and other relevant indication-specific criteria identified in the initial approval criteria.
    • The patient has no unacceptable toxicity from Pedmark (sodium thiosulfate).

      Examples of unacceptable toxicity include hypersensitivity reactions, hypernatremia, hypokalemia, and severe nausea/vomiting.

    • The patient continues to require chemoprotective treatment to counteract cisplatin ototoxicity.

    Quantity Limits

    Pedmark (sodium thiosulfate)
    ProductPedmark (sodium thiosulfate).
    Maximum quantity500 billable HCPCS units every 14 days.
    Equivalent dose500 billable HCPCS units equals 50 g.
    Policy Summary
    PayerSecurity Health Plan of Wisconsin, Inc.
    PolicyPedmark (sodium thiosulfate) Intravenous Therapy
    Policy CodePolicy IC-0679
    Change TypeNo material change
    Effective DateN/A
    Last ReviewJul 1, 2025
    Next Review DateN/A
    Key ActionObtain prior authorization; initial approval is valid for 12 weeks (84 days), with renewal available in additional 12-week periods.
    SourceLink
    On This Page
    Coverage CriteriaCoding and Clinical ParametersProvider Actions and Denial RisksBackgroundDefinitionsInitial Therapy CriteriaContinuation CriteriaQuantity Limits