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    v1.0.31
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsTennCare ED Medications Prior Auth | OpenPayer
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    CurrentTennessee Department of Finance and Administration — Division of TennCarePolicy BEN 06-001 (Rev 9)

    Erectile Dysfunction (ED) Medications

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    This policy governs TennCare coverage and prior-authorization handling for medications, compounds, and devices used to treat erectile dysfunction or sexual dysfunction. ED agents are generally excluded, but sildenafil citrate and tadalafil may be covered for a medically necessary, FDA-approved non-ED indication such as pulmonary arterial hypertension when applicable requirements are met.

    Policy Summary
    PayerTennessee Department of Finance and Administration — Division of TennCare
    PolicyErectile Dysfunction (ED) Medications
    Policy CodePolicy N/A
    Change TypeNo material clinical or coverage change
    Effective DateOct 28, 2025
    Last ReviewMar 12, 2009
    Next Review DateN/A
    Key ActionObtain prior approval for all pharmacy compounds used to treat pulmonary arterial hypertension.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    All ED agents and devicesGenerally excluded from coverage
    2ED agents with potential non-ED coverage exception
    PA required

    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.

    Requirement for all pharmacy compounds used to treat PAH
    API or bulk powderCovered compound ingredients when available

    Coverage Criteria

    Non-ED FDA-approved indication

    Sildenafil citrate or tadalafil may be covered when all of the following are met.

    Non-ED coverage exception: The drug is prescribed for a medically necessary, FDA-approved indication other than erectile dysfunction or sexual dysfunction, such as pulmonary arterial hypertension.FDA-approved non-ED indication

    Federal and state Medicaid requirements must also be satisfied.

    PAH pharmacy compound

    A pharmacy compound containing sildenafil citrate or tadalafil may be approved when all of the following are met.

    PAH compound criteria

    • Required compound conditions

      • Reason commercial product cannot be used: The patient is unable to swallow tablets, requires a medication strength that is not commercially available, or has a documented allergy to an excipient in the commercial product.At least one documented reason
    • Ingredient and authorization requirements: The compound is prescribed for pulmonary arterial hypertension; it uses covered sildenafil citrate or tadalafil active pharmaceutical ingredient or bulk chemical powder when available; and prior approval, drug utilization review, and claim-system edits have been completed.PAH; covered API or bulk powder when available; prior approval required

    Pharmaceuticals prescribed for impotence or sexual dysfunction are excluded from coverage. This exclusion applies to all forms of erectile dysfunction therapy, including FDA-approved and non-FDA-approved oral agents, urethral pellets, intercavernous injections, implantable devices, and related therapies such as dietary supplements.

    A pharmacy compound containing sildenafil citrate or tadalafil will be rejected when it is filled with a commercially available product instead of sildenafil citrate powder or tadalafil powder, when the powder is available. TennCare prefers use of the available covered powder form in the compound.

    Initial Therapy Criteria

    Initial non-ED therapy

    Initial coverage for sildenafil citrate or tadalafil requires use for a medically necessary, FDA-approved indication other than erectile dysfunction or sexual dysfunction.

    Eligible non-ED use: The requested agent is sildenafil citrate or tadalafil and is prescribed for a medically necessary, FDA-approved indication other than sexual or erectile dysfunction, such as pulmonary arterial hypertension.FDA-approved non-ED indication

    The prescription must comply with federal and state Medicaid requirements.

    Initial compounded therapy

    Initial coverage for a pharmacy compound requires prior approval and all compound-specific criteria.

    Compounded PAH therapy

    • Required compound conditions

    Provider Actions and Authorization Requirements

    Prior Authorization

    Prior Approval Required for PAH Compounds

    Prior approval is required for every pharmacy compound used to treat pulmonary arterial hypertension (PAH). Submit the compound for prior approval before dispensing; utilization review and claim-system edits must also be resolved.

    Documentation Required

    FDA-Approved Non-ED Indication Required

    Coverage may be available for sildenafil citrate or tadalafil only when prescribed for a medically necessary, FDA-approved indication other than erectile dysfunction (ED), such as PAH, and in compliance with federal and state Medicaid requirements.

    • The indication must be documented as medically necessary and FDA-approved.
    • Coverage is not available when the agent is prescribed for impotence or sexual dysfunction.

    Preferred PAH Therapy

    StepRequirementProvider action
    1The requested agent is not FDA-approved for pulmonary arterial hypertension (PAH).Use a preferred agent on the TennCare Preferred Drug List that is indicated for PAH.

    Policy Background

    Erectile dysfunction therapies may include oral agents, compounded formulations, urethral products, intercavernous injections, implantable devices, and dietary supplements. Although these therapies are generally excluded when prescribed for impotence or sexual dysfunction, sildenafil citrate and tadalafil may be eligible for coverage when prescribed for a medically necessary, FDA-approved non-ED indication, such as pulmonary arterial hypertension (PAH), in accordance with federal and state Medicaid requirements.

    Pharmacy compounds containing sildenafil citrate or tadalafil are limited to treatment of PAH when the patient cannot use a commercially available product—for example, because the patient cannot swallow tablets, needs a strength that is not commercially available, or has a documented allergy to an excipient in the commercial product. When available, the compound must use the covered active pharmaceutical ingredient (API) or bulk chemical powder rather than a commercially available product.

    Key Definitions

    Non-ED FDA-approved indication
    DefinitionA medically necessary, FDA-approved indication other than sexual or erectile dysfunction.
    ExamplePulmonary arterial hypertension (PAH).
    Applicable agentsSildenafil citrate or tadalafil may be eligible for coverage when prescribed for this type of indication.
    Covered API or bulk chemical powder
    DefinitionThe active pharmaceutical ingredient (API) or bulk chemical powder form of sildenafil citrate or tadalafil used to prepare a pharmacy compound.
    Covered ingredientsSildenafil citrate API or bulk chemical powder; tadalafil API or bulk chemical powder.
    Policy Summary
    PayerTennessee Department of Finance and Administration — Division of TennCare
    PolicyErectile Dysfunction (ED) Medications
    Policy CodePolicy N/A
    Change TypeNo material clinical or coverage change
    Effective DateOct 28, 2025
    Last ReviewMar 12, 2009
    Next Review DateN/A
    Key ActionObtain prior approval for all pharmacy compounds used to treat pulmonary arterial hypertension.
    SourceLink
    On This Page
    Coverage CriteriaInitial Therapy CriteriaProvider Actions and Authorization RequirementsPreferred PAH TherapyPolicy BackgroundKey Definitions
    Commercial-product limitation: The patient cannot swallow tablets, needs a medication strength that is not commercially available, or has a documented allergy to an excipient in the commercial product.One documented limitation
  1. PAH, ingredient, and authorization requirements: The compound is used for pulmonary arterial hypertension; sildenafil citrate powder or tadalafil powder is used when available; and prior approval, drug utilization review, and claim-system edits have been completed.PAH plus preferred ingredient selection and prior approval
    2. Step Therapy

    Use Preferred PAH Agents

    When requesting authorization for a PAH agent that is not FDA-approved for PAH, direct the request to a preferred PAH agent identified on TennCare’s Preferred Drug List (PDL) as an alternative.

    • Use the preferred PAH agents listed on the TennCare PDL whenever applicable.
    Documentation Required

    Document the Compound Exception

    For a compounded sildenafil citrate or tadalafil prescription, document the medically necessary PAH indication and why compounded therapy is required instead of a commercially available product.

    • Document that the patient cannot swallow tablets, requires a strength that is not commercially available, or has a documented allergy to an excipient in the commercial product.
    Billing Rule

    Document the Compound Ingredient

    Identify whether the compound uses the covered active pharmaceutical ingredient (API) or bulk chemical powder form of sildenafil citrate or tadalafil. Use the API or bulk powder when available rather than a commercially available product.

    • Compounds filled with sildenafil citrate powder or tadalafil powder may be paid once prior approval criteria, utilization review, and claim edits are satisfied.
    • Compounds filled with commercially available products may be rejected as requiring additional prior approval.
    Denial Risk

    ED Prescriptions Denied at Point of Sale

    Commercially available dosage forms prescribed for ED are denied at the point of sale as non-covered products.

    • This includes commercially available oral ED medications and other dosage forms prescribed for ED.
    Denial Risk

    Sexual Dysfunction Use Is Excluded

    Coverage is unavailable for oral, urethral, injectable, dietary-supplement, implantable, or other agents and devices when used to treat impotence or sexual dysfunction.

    • Examples include sildenafil, vardenafil, avanafil, tadalafil, yohimbine, alprostadil urethral pellets, and intercavernous injections.
    Denial Risk

    Commercial Product in a Compound

    A compound containing a commercially available sildenafil citrate or tadalafil product may be rejected as requiring additional prior approval. TennCare prefers sildenafil citrate powder or tadalafil powder, if available.

    • The PBM call center will explain the preferred powder formulation and additional authorization requirements.
    Step Therapy

    Redirect Non-FDA-Approved PAH Requests

    If authorization is requested for PAH treatment with an agent that is not FDA-approved for PAH, the PBM call center will direct the physician to a preferred PAH agent on TennCare’s PDL as an alternative.

    • Redirect non-FDA-approved PAH requests to the preferred agents indicated on the PDL.
    Compound requirement
    Use the covered API or bulk chemical powder instead of a commercially available product when available.