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    v1.0.28
    OpenPayerPolicy UpdatesObstetrics/GynecologyAmeriHealth Caritas prescription digital contracep…
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    CurrentAmeriHealth CaritasPolicy CCP.1545

    Prescription digital therapeutics for contraception

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

    Policy Summary
    PayerAmeriHealth Caritas
    PolicyPrescription digital therapeutics for contraception
    Policy CodePolicy CCP.1545
    Change TypeClarified references
    Effective DateSep 1, 2024
    Last ReviewAug 1, 2025
    Next Review DateDec 1, 202639d
    Key ActionObtain prior authorization when plan- or state-specific requirements and clinical criteria are met for FDA-cleared prescription digital therapeutics (Natural Cycles version 3.0 and Clue Birth Control).
    SourceLink
    POLICY UPDATE CHANGES

    Policy references updated.

    2FDA-cleared prescription digital therapeutics named
    18+min age for Natural Cycles (yrs)
    18-45eligible age range for Clue
    5.0–6.9Typical-use Pearl Index

    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.

    NoneAbsolute contraindications

    Coverage Criteria

    Product-specific coverage criteria

    Covered when ALL of the following product-specific criteria are met

    Natural Cycles coverage: Member is female and age ≥18 years; product is Natural Cycles (version 3.0); provided in accordance with plan- or state-specific requirements; member counseled on method limitations and suitability (e.g., may not be appropriate for patients with underlying medical conditions in whom pregnancy would be associated with significant risk)age >= 18

    Manufacturer-sponsored studies excluded users with conditions affecting cycle length/variability

    Use of fertility-awareness prescription digital therapeutics should be approached with caution or deferred when transient or chronic conditions are present that interfere with accurate detection of fertile windows. Examples include irregular menstrual cycles, breastfeeding, and the post‑abortion period, as well as reproductive tract infections or diseases. Drugs that alter cycle regularity, hormones, or fertility signs and acute or chronic illnesses that elevate body temperature may also impair algorithm performance and are reasons to delay initiation until the condition is resolved or controlled.

    Coverage for FDA‑cleared prescription digital therapeutics for contraception should be limited to selected patient populations — specifically those for whom traditional contraceptive methods are contraindicated, unsuitable, or declined after counseling. This restriction reflects evidence showing that fertility‑awareness applications have lower typical‑use effectiveness than standard methods (for example, typical‑use pregnancy rates markedly higher than long‑acting reversible contraception), and the absence of direct comparative trials. Limiting coverage to carefully selected patients with mandatory counseling helps mitigate the higher risk of unintended pregnancy and associated clinical and cost consequences.

    Coding and Product Characteristics

    FDA document referencesmixed
    K193330FDA documentation reference for Clue birth control (approval letter PDF)
    DEN170052De novo request classification reference for Natural Cycles
    K231274FDA approval letter reference for Natural Cycles (2023)
    Cycle characteristics for Clue Birth Control
    Required cycle lengthPredictable 20- to 40-day menstrual cycles
    Allowed cycle variabilityCycle variation less than 10 days
    Post-hormonal contraception/pregnancy timingAt least three cycles (four periods) after stopping hormonal birth control or since the end of a pregnancy

    Provider Actions and Prior Authorization

    Prior Authorization

    Prior authorization required for FDA‑cleared apps per plan/state rules

    Coverage is limited to FDA-cleared prescription digital therapeutics (Natural Cycles version 3.0 and Clue Birth Control) and is provided only when plan- or state-specific requirements and the policy’s clinical criteria are met; prior authorization may be required per plan or state rules and for conditions noted as exclusions.

    Step Therapy

    Use after considering standard covered contraceptive alternatives

    Consider prescription digital therapeutics only after discussing and offering standard covered contraceptive options; digital therapeutics are intended for patients who prefer non‑hormonal methods or for whom traditional methods are contraindicated or unsuitable.

    • Alternative covered services include IUDs, progestin-only methods (oral, injection, implant), combined hormonal methods (oral, patch, ring), barrier methods, sterilization, and contraceptive counseling.

    Background

    Fertility‑awareness methods identify fertile and infertile phases of the menstrual cycle by tracking physiologic signs or applying calendar rules. Symptom‑based approaches assess signals such as cervical mucus characteristics and basal body temperature, while algorithm‑driven prescription digital therapeutics combine these inputs with cycle history to predict fertile days. The effectiveness of these methods depends strongly on menstrual regularity and consistent, correct use; many clinical evaluations and product labeling require predictable cycle patterns and adequate data collection (for example, multiple cycles of input) for reliable performance. Because these methods do not protect against sexually transmitted infections, counseling on barrier methods is also essential.

    Definitions

    Prescription digital therapeutics (definition)
    DefinitionEvidence-based software applications authorized or cleared by the U.S. Food and Drug Administration used to treat or manage medical conditions and available only by prescription by a licensed clinician.
    Regulatory statusClass II software applications (FDA-authorized/cleared)
    Use modelsMay be used as stand-alone or adjunct interventions for clinical management
    Fertility-awareness methods (definition)
    DefinitionMethods based on identifying and avoiding the fertile period of the menstrual cycle using physiologic signs or calendar rules (symptom-based or calendar-based).
    ExamplesSymptom-based: cervical mucus, basal body temperature, symptothermal methods; Calendar-based: Standard Days Method.

    Revision History

    2024-09-01effective_date

    Clinical policy became effective on 2024-09-01 following initial review in August 2024.

    2025-08-01references_updatedLatest

    Policy references updated on 2025-08 per policy updates.

    Policy Summary
    PayerAmeriHealth Caritas
    PolicyPrescription digital therapeutics for contraception
    Policy CodePolicy CCP.1545
    Change TypeClarified references
    Effective DateSep 1, 2024
    Last ReviewAug 1, 2025
    Next Review DateDec 1, 202639d
    Key ActionObtain prior authorization when plan- or state-specific requirements and clinical criteria are met for FDA-cleared prescription digital therapeutics (Natural Cycles version 3.0 and Clue Birth Control).
    SourceLink
    On This Page
    Coverage CriteriaCoding and Product CharacteristicsProvider Actions and Prior AuthorizationBackgroundDefinitionsRevision History
    Documentation Required

    Document age, cycle regularity, prior contraceptive/pregnancy history, and counseling

    Document patient age and counseling, and for Clue Birth Control explicitly document menstrual cycle characteristics and prior hormonal contraceptive or pregnancy history when applicable.

    • Patient age (Natural Cycles: ≥18 years; Clue Birth Control: 18–45 years).
    • For Clue: predictable 20–40 day cycles with <10 days variation and, if applicable, at least three cycles (four periods) after stopping hormonal contraception or since the most recent pregnancy.
    • Documentation of counseling on method limitations and need for barrier methods for STI protection.
    Denial Risk

    Screen for conditions that may trigger exclusion or special authorization

    Identify patients with conditions that may require exclusion or special authorization and avoid routine approval without additional review for these situations.

    • Teratogenic medication use.
    • Irregular menstrual cycles.
    • Breastfeeding or post‑abortion care.
    • Reproductive tract infections or diseases.
    • Use of drugs that affect cycle regularity or fertility signs.
    • Acute or chronic conditions that elevate body temperature.
    Typical useMay be used with abstinence or barrier methods during fertile times; effectiveness depends on menstrual regularity and correct, consistent use.