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    v1.0.28
    OpenPayerPolicy UpdatesObstetrics/Gynecologyselect_health prescription digital contraception C…
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    Currentselect_healthPolicy CCP.1545

    Prescription digital therapeutics for contraception

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    Defines coverage criteria and limitations for FDA-cleared prescription digital therapeutics (mobile apps) used as fertility-awareness contraception methods (Natural Cycles and Clue Birth Control) for eligible female members.

    Policy Summary
    Payerselect_health
    PolicyPrescription digital therapeutics for contraception
    Policy CodePolicy CCP.1545
    Change TypeReferences updated (administrative)
    Effective DateSep 1, 2024
    Last ReviewAug 1, 2025
    Next Review DateDec 1, 202639d
    Key ActionObtain plan- or state-specific prior authorization and document member age and required cycle information when prescribing a covered prescription digital therapeutic.
    SourceLink
    POLICY UPDATE CHANGES

    Policy references updated.

    2products covered
    18+min age (Natural Cycles)
    18-45age range (Clue)
    20-40dcycle length (Clue)

    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.

    ≥3prior cycles required (Clue)

    Coverage Criteria for Prescription Digital Therapeutics

    Initial coverage criteria

    Covered when ALL of the following are met

    General coverage

    • Product-specific

      • Natural Cycles (version 3.0) for female members age 18 years or older.

        Reference: Natural Cycles intended for patients 18 years and older; users who recently used hormonal contraception may have higher pregnancy risk.

      • Clue Birth Control for female members ages 18 to 45 years with predictable 20- to 40-day cycles (cycle variation < 10 days) and, if applicable, at least three cycles (four periods) after stopping hormonal birth control or since the end of the most recent pregnancy.20-40 day cycles; variation <10 days; ≥ 3 cycles when applicable

        Reference: Clue requires predictable cycles and prior cycles after hormonal contraception or pregnancy as specified.

    Provider/plan requirements: Prescription and provision in accordance with plan- or state-specific requirements (prior authorization may apply).

    Document member age, cycle characteristics, prior cycles after hormonal contraception or pregnancy, and any device/sensor inputs used (e.g., basal body temperature entries).

    Use of fertility-awareness prescription digital therapeutics should be approached with caution or delayed when clinical conditions may interfere with accurate identification of the fertile window. Examples include irregular menstrual cycles, breastfeeding, or the immediate post‑abortion period, as these situations can alter cycle patterns or fertility signs and impair algorithm performance. Additional conditions warranting caution include reproductive tract infections or diseases, use of medications that affect cycle regularity or hormonal status, and acute or chronic illnesses that elevate body temperature, any of which may require correction or special authorization before use.

    Coverage of prescription digital therapeutics for contraception should be limited to selected patient populations and may be inappropriate where traditional contraceptive methods are suitable. Professional guidance recommends restricting use to patients who prefer non‑hormonal options or for whom other methods are contraindicated or unsuitable, and implementing mandatory counseling to ensure appropriate use and to address the higher typical‑use pregnancy rates compared with standard methods.

    Provider Actions, Documentation, and Alternatives

    Prior Authorization

    Plan-/state-specific prior authorization may be required

    Coverage is allowed only when the prescription digital therapeutic is provided in accordance with plan- or state-specific requirements; prior authorization may apply per the member's plan or state rules.

    Note

    Alternative covered contraceptive options

    Alternative covered contraceptive services are available and should be considered when prescription digital therapeutics are unsuitable.

    • Intrauterine devices (IUDs).
    • Progestin-only contraceptives (oral, injection, implant).
    • Combined hormonal contraceptives (oral, patch, vaginal ring).
    • Barrier methods (diaphragm, cervical cap, sponge, male and female condoms, spermicides).
    • Female and male sterilization.
    • Contraceptive counseling.

    Definitions

    Prescription digital therapeutic — definition and key facts
    DefinitionAn evidence-based, FDA-authorized/cleared software application used to treat or manage medical conditions, available only by prescription and may be stand-alone or adjunctive.
    Device class and availabilityPrescription digital therapeutics for contraception are Class II software applications cleared by the U.S. Food and Drug Administration and are available only by prescription by a licensed clinician.
    Intended use examplesUsed to predict fertile and non-fertile days and provide patient-specific contraception recommendations via proprietary algorithms.
    Input requirements (examples)User-entered data such as daily basal body temperature, menstruation start date and duration, and optional ovulation or pregnancy test results; temperature may be captured via devices like Apple Watch, Bluetooth thermometers, or Oura Ring.
    Product variabilityProducts differ in intended user populations, user input requirements, and technical characteristics (e.g., Natural Cycles vs. Clue Birth Control).

    Background

    Fertility‑awareness methods identify the fertile period by tracking physiologic symptoms or applying calendar rules. Common signals used by these methods include changes in cervical mucus and basal body temperature, which can be entered into an application to predict fertile days; calendar‑based algorithms may also be used depending on the product. These approaches rely on regular menstrual patterns and consistent, correct input to perform accurately, and therefore have higher typical‑use failure rates than long‑acting or hormonal contraceptives. Prescription digital therapeutics (for example, Natural Cycles and Clue Birth Control) are FDA‑cleared software‑only devices that implement these symptom‑ or calendar‑based algorithms and differ by intended users, required inputs, and validation data, so selection should match the member’s cycle characteristics and ability to comply with data entry requirements.

    Policy Summary
    Payerselect_health
    PolicyPrescription digital therapeutics for contraception
    Policy CodePolicy CCP.1545
    Change TypeReferences updated (administrative)
    Effective DateSep 1, 2024
    Last ReviewAug 1, 2025
    Next Review DateDec 1, 202639d
    Key ActionObtain plan- or state-specific prior authorization and document member age and required cycle information when prescribing a covered prescription digital therapeutic.
    SourceLink
    On This Page
    Coverage Criteria for Prescription Digital TherapeuticsProvider Actions, Documentation, and AlternativesDefinitionsBackground
    Documentation Required

    Required clinical documentation to verify eligibility and inputs

    Clinical documentation must support that the member meets product-specific eligibility and input requirements.

    • Member age consistent with product: Natural Cycles ≥18 years; Clue Birth Control 18–45 years.
    • For Clue Birth Control, documentation of predictable 20–40 day cycles with variation <10 days.
    • If applicable for Clue, record of at least three cycles (four periods) after stopping hormonal contraception or since the most recent pregnancy.
    • Records of device/sensor inputs or user-entered data used by the app (e.g., daily basal body temperature entries, period start dates, ovulation or pregnancy test results).
    Denial Risk

    Conditions requiring caution, possible exclusion, or special authorization

    Use with caution or delay may be required for conditions that impair cycle regularity or the accuracy of fertility signals and could trigger exclusion or special authorization.

    • Irregular menstrual cycles.
    • Breastfeeding or post-abortion care.
    • Reproductive tract infections or diseases.
    • Use of drugs that affect cycle regularity, hormones, or fertility signs.
    • Acute or chronic conditions that elevate body temperature (which can interfere with basal body temperature measurements).
    Fertility-awareness methods — definition and key facts
    DefinitionContraceptive approaches based on identifying and avoiding the fertile period using symptoms (cervical mucus, basal body temperature, symptothermal) or calendar-based rules.
    Typical use and limitationsMay be used with abstinence or barrier methods during fertile time; associated with higher failure rates and effectiveness depends on menstrual regularity and consistent correct use.
    Example products using fertility-awarenessNatural Cycles and Clue Birth Control are prescription digital therapeutics that implement fertility-awareness algorithms to predict fertile and non-fertile days.
    User requirements (product-specific)Clue Birth Control: ages 18–45 with predictable 20–40 day cycles (variation <10 days) and ≥3 cycles after stopping hormonal contraception or since last pregnancy; Natural Cycles: intended for patients 18 years and older with daily basal temperature and cycle data entry.
    Clinical considerationEffectiveness depends on menstrual regularity and correct, consistent use throughout the menstrual cycle; may be inappropriate for patients with conditions that make pregnancy high risk.