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    v1.0.28
    OpenPayerPolicy UpdatesObstetrics/GynecologyPriority Health Recurrent Pregnancy Loss Policy Up…
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    Modifiedpriority healthPolicy NO. 91156

    RECURRENT PREGNANCY LOSS

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    Defines medical necessity criteria for evaluation and treatment of recurrent pregnancy loss (RPL) and lists tests and therapies considered medically necessary, not medically necessary, or experimental for Priority Health members.

    Policy Summary
    Payerpriority health
    PolicyRecurrent Pregnancy Loss
    Policy CodePolicy NO. 91156
    Change TypeMaterial content added and criteria reorganized
    Effective DateJun 1, 2026
    Last ReviewMay 13, 2026
    Next Review DateMay 13, 2026
    Key ActionWhen prior authorization is required, submit documentation demonstrating medical necessity per Priority Health Provider Manual and Evicore guidelines.
    SourceLink
    POLICY UPDATE CHANGES

    Medically necessary tests/studies/indications for evaluation and treatment of RPL were added.

    Not medically necessary tests/studies for evaluation and treatment of RPL were added.

    Medical necessity criteria were reorganized to distinguish evidence-based evaluation and treatment versus tests and therapies lacking demonstrated clinical benefit.

    New Policy scope section was added.

    New Medical/Professional Society Guidelines section was added.

    New Government Regulations section listing applicable CMS NCDs or LCDs was added.

    New FDA/Regulatory section was added.

    Removed outdated references and legacy content no longer aligned with current evidence.

    2+first-trimester threshold
    1+second-trimester threshold
    multipleTests/therapies listed as not medically necessary
    Aspirin+heparinAPS treatment recommended
    2Trials/meta-analyses cited
    severalexplicit experimental services listed

    Coverage and Medical Necessity Criteria

    inv-01: Indications for RPL evaluation

    Evaluation may be considered medically necessary when ANY of the following are met:

    RPL evaluation criteria: Two (2) or more clinically recognized first‑trimester pregnancy losses documented by ultrasonography or histopathologic examination; OR a history of one or more pregnancy losses in the second trimester or later, regardless of preceding first‑trimester losses.See text

    Policy diagnostic threshold for initiating RPL evaluation.

    inv-02: Medically necessary diagnostic tests

    Diagnostic tests considered medically necessary for RPL evaluation (when clinically indicated):

    Medically necessary diagnostic elements: Targeted history and physical examination (obstetric, medical, surgical, genetic, family history); anatomic evaluation of the uterus using pelvic ultrasound and/or saline infusion sonohysterography, hysterosalpingography, or hysteroscopy; genetic evaluation including cytogenetic analysis of products of conception when available and parental peripheral blood karyotyping only when products of conception demonstrate an unbalanced structural abnormality or when pregnancy tissue is unavailable after recurrent losses; antiphospholipid syndrome testing including lupus anticoagulant, anti‑cardiolipin (IgG/IgM), and anti‑β2‑glycoprotein I (IgG and/or IgM); targeted thyroid testing (TSH) and thyroid peroxidase (TPO) when clinically indicated.
    Policy Summary
    Payerpriority health
    PolicyRecurrent Pregnancy Loss
    Policy CodePolicy NO. 91156
    Change TypeMaterial content added and criteria reorganized
    Effective DateJun 1, 2026
    Last ReviewMay 13, 2026
    Next Review DateMay 13, 2026
    Key ActionWhen prior authorization is required, submit documentation demonstrating medical necessity per Priority Health Provider Manual and Evicore guidelines.
    SourceLink
    On This Page
    Coverage and Medical Necessity CriteriaDiagnosis, Procedure, and Drug CodesPrior Authorization, Documentation, and Operational GuidanceBackground and Evidence SummaryDefinitions and Regulatory TermsPolicy Revision History
    Clinical indication

    Listed as medically necessary tests in policy.

    inv-03: Medically necessary treatments

    Treatments considered medically necessary for RPL (when clinically appropriate):

    Medically necessary treatments: Low‑dose aspirin plus heparin therapy for members diagnosed with antiphospholipid syndrome; surgical correction of clinically significant uterine structural abnormalities when appropriate; cervical cerclage (transvaginal or transabdominal) for documented cervical insufficiency; vaginal progesterone for individuals with recurrent pregnancy loss who present with vaginal bleeding in the first trimester when supported by guideline recommendations.Diagnosis‑specific

    Treatment recommendations target identified, potentially modifiable causes per guideline-supported evidence.

    inv-04: Medical necessity and prior authorization

    Coverage and prior authorization:

    Medical necessity and authorization: Providers must follow member‑specific benefits. Prior authorization may be required for certain drugs, devices, services and procedures; when prior authorization is required, submit documentation demonstrating medical necessity per the Priority Health Provider Manual and Evicore criteria. Individual case review may allow coverage for investigational yet promising care; determinations for experimental or unproven treatments will be made by a Priority Health medical director or clinical pharmacist.Per plan/Evicore

    See Priority Health Provider Manual and Evicore guidelines via Priority Health Prism.

    inv-05: Covered vs Not Covered Criteria (reorganized)

    Coverage is organized to distinguish interventions supported by current evidence from those not demonstrating clinical benefit:

    Evidence‑based evaluation and treatment: The policy reorganizes medical necessity to list medically necessary tests, studies, indications, and treatments for RPL based on recent randomized trials, meta‑analyses, and society guideline recommendations; these are considered evidence‑based and appropriate when criteria are met.

    See policy sections for specific test and treatment criteria.

    Not medically necessary tests/therapies: The policy explicitly identifies tests and therapies considered not medically necessary or experimental due to lack of demonstrated clinical benefit (examples include routine inherited thrombophilia testing solely for first‑trimester RPL without personal VTE history, broad reproductive immunophenotyping and NK cell assays, MTHFR and other genetic polymorphism testing, routine endometrial biopsy for luteal dating, levothyroxine in euthyroid TPO‑positive individuals, empiric G‑CSF, IVIG, intralipid, corticosteroids for immune modulation, and paternal leukocyte immunization). Use of these listed interventions may be denied or require individual case review.

    Not medically necessary/excluded items are listed in the policy and may trigger denial.

    Inherited thrombophilia testing (for example, Factor V Leiden or prothrombin gene mutation) performed solely to explain recurrent first‑trimester pregnancy loss is listed as not medically necessary when there is no personal history of venous thromboembolism (VTE) or other established clinical indications. The policy distinguishes targeted thrombophilia evaluation when clinically indicated from broad thrombophilia panels ordered only for unexplained early RPL, which are not supported by evidence of improved outcomes.

    Specific reproductive immunophenotyping and natural killer (NK) cell testing are listed as not medically necessary/experimental. This includes lymphocyte subset panels (e.g., CD3+, CD4+, CD8+, CD16+, CD19+, CD56+), NK cell number/percentage and NK cytotoxicity or functional assays, and related flow cytometry analyses — these tests are excluded because they have not been shown to change management or improve pregnancy outcomes.

    The regulatory (FDA) section in this excerpt does not contain specific coverage criteria, exclusions, or medical necessity statements; instead it lists placeholders for 510(k)/PMA/De Novo identifiers and directs readers to the FDA Medical Device Databases for current device status.

    Examples of services explicitly listed as not medically necessary or considered experimental include lymphocyte immunotherapy (allogeneic lymphocyte infusions), NK cell testing (flow cytometry–based assays and their interpretations), and MTHFR polymorphism testing (genetic polymorphism analysis). These items are designated not medically necessary due to lack of demonstrated clinical benefit in RPL evaluation or management.

    The policy operationally separates tests and therapies that lack demonstrated clinical benefit into a distinct not‑medically‑necessary grouping; use of tests or treatments listed in that grouping may be denied because they are not supported by evidence of improved clinical outcomes.

    Specific treatments designated not medically necessary include levothyroxine therapy in euthyroid individuals with thyroid antibodies and empiric progesterone for sporadic miscarriage or for asymptomatic RPL in the absence of vaginal bleeding. These recommendations follow recent randomized trials and society guidance that do not demonstrate consistent benefit for routine use in these settings.

    Immune‑modulating or investigational therapies such as intravenous immunoglobulin (IVIG), intralipid infusions, and systemic corticosteroids used solely for immune modulation are classified as not medically necessary/experimental. The policy cites inconsistent randomized evidence and concerns about heterogeneity, cost, and safety; these therapies are not recommended for routine management of RPL and remain investigational outside of clinical trials.

    Routine endometrial biopsy performed only for luteal phase dating is identified as not medically necessary (CPT 58100). The policy also notes that a range of immunologic and genetic polymorphism tests (for example, routine thyroid antibody screening without indication and MTHFR testing) are not supported for routine RPL evaluation and are considered experimental or unproven.

    The policy adds explicit lists of tests and studies designated medically necessary and those designated not medically necessary for evaluation and treatment of recurrent pregnancy loss. This reorganized structure is intended to clearly separate evidence‑based diagnostic and therapeutic interventions from tests and therapies that lack demonstrated clinical benefit.

    Diagnosis, Procedure, and Drug Codes

    ICD-10 Codes that may support medical necessityICD-10
    N96Recurrent pregnancy loss
    O09.211-O09.219Supervision of pregnancy with history of pre-term labor
    O09.291-O09.299Supervision of pregnancy with other poor reproductive or obstetric history
    O26.20-O26.23Pregnancy care for patient with recurrent pregnancy loss Encounter for testing of male partner of patient with recurrent pregnancy loss
    Z31.441
    ICD-10 Codes that may support medical necessityICD-10
    N96Recurrent pregnancy loss
    O09.211-O09.219Supervision of pregnancy with history of pre-term labor
    O09.291-O09.299Supervision of pregnancy with other poor reproductive or obstetric history
    O26.20-O26.23Pregnancy care for patient with recurrent pregnancy loss
    Z31.441Encounter for testing of male partner of patient with recurrent pregnancy loss
    Office VisitsCPTCovered
    99202-99205New patient E/M
    99212-99215Established patient E/M
    Uterine Anatomic EvaluationCPTCovered
    58340Catheterization and introduction of saline or contrast material for saline infusion sonohysterography (SIS) or hysterosalpingography
    58555Hysteroscopy, diagnostic (separate procedure)
    74740Hysterosalpingography, radiological supervision and interpretation
    76830Ultrasound, transvaginal
    76831Saline infusion sonohysterography (SIS), including color flow Doppler, when performed
    76856Ultrasound, pelvic (nonobstetric), real time with image documentation; complete
    76857Ultrasound, pelvic (nonobstetric), real time with image documentation; limited or follow-up (eg, for follicles)
    Genetic / Cytogenetic TestingCPTCovered
    88230Tissue culture for non-neoplastic disorders; lymphocyte
    88233Tissue culture for non-neoplastic disorders; skin or other solid tissue biopsy
    88240Cryopreservation, freezing and storage of cells, each cell line
    88262Chromosome analysis; count 15-20 cells, 2 karyotypes, with banding
    88285Chromosome analysis; additional cells counted, each study
    88291Cytogenetics and molecular cytogenetics, interpretation and report (parents, when criteria met)
    Antiphospholipid Syndrome (APS) TestingCPTCovered
    85613Russell viper venom time (includes venom); diluted
    86146Beta 2 Glycoprotein I antibody, each
    86147Cardiolipin (phospholipid) antibody, each Ig class
    Endocrine Testing (Targeted)mixedCovered
    81241F5 (coagulation factor V) gene analysis, Leiden variant
    84443Thyroid stimulating hormone (TSH)
    86376Microsomal antibodies (eg, thyroid or liver-kidney), each (TPO)
    Not medically necessary - Considered Experimental/Investigational/UnprovenmixedNot Covered
    38242Allogeneic lymphocyte infusions
    88184Flow cytometry, cell surface, cytoplasmic, or nuclear marker, technical component only; first marker
    88185Flow cytometry, cell surface, cytoplasmic, or nuclear marker, technical component only; each additional marker (List separately in addition to code for first marker)
    88187Flow cytometry, interpretation; 2 to 8 markers
    88188Flow cytometry, interpretation; 9 to 15 markers
    88189Flow cytometry, interpretation; 16 or more markers
    83516Immunoassay for analyte other than infectious agent antibody or infectious agent antigen; qualitative or semiquantitative, multiple step method
    81240F2 (prothrombin, coagulation factor II) gene analysis, 20210G>A variant
    81241F5 (coagulation factor V) gene analysis, Leiden variant
    85300Clotting inhibitors or anticoagulants; antithrombin III, activity
    1–10 of 14
    1/2
    Endometrial Biopsy for Dating (Routine Use)CPTNot Covered
    58100Endometrial sampling (biopsy) with or without endocervical sampling (biopsy), without cervical dilation, any method (separate procedure) ( luteal phase dating only)
    Infectious / Microbiome TestingCPTExperimental
    0607UReproductive medicine (endometrial microbiome assessment), real-time PCR analysis for 31 bacterial DNA targets from endometrial biopsy, reported with quantified levels of bacterial presence and targeted treatment recommendations
    0608UReproductive medicine (endometrial microbiome assessment), real-time PCR analysis for 10 bacterial DNA targets from endometrial biopsy, reported with quantified levels of bacterial presence and targeted treatment recommendations
    Granulocyte Colony-Stimulating Factor Filgrastim (G-CSF)HCPCS
    J1442Injection, filgrastim (G-CSF), excludes biosimilars, 1 mcg
    J1447Injection, tbo-filgrastim, 1 mcg
    J1449Injection, eflapegrastim-xnst, 0.1 mg
    Immunomodulating Therapies (IVIG) and Intralipidmixed
    J1561Injection, immune globulin, (Gamunex/Gamunex-C/Gammaked), nonlyophilized (e.g., liquid), 500 mg
    J1569Injection, immune globulin, (Gammagard liquid), nonlyophilized, (e.g., liquid), 500 mg
    J1572Injection, immune globulin, (Flebogamma/Flebogamma Dif), intravenous, nonlyophilized (e.g., liquid), 500 mg
    96365-96368Infusion services when billed with IVIG or intralipid
    J3490Unclassified drugs
    J3590Unclassified biologics
    No explicit CPT/ICD codes listed in this sectionmixed
    No codes listed
    Diagnostic loss threshold — evaluation triggers
    Diagnostic loss thresholdTwo or more clinically recognized first‑trimester pregnancy losses documented by ultrasonography or histopathologic examination; OR one or more pregnancy losses in the second trimester or later.
    Evidence baseContemporary guidance (ACOG, ESHRE) supports evaluation after two clinically recognized first‑trimester losses; RCOG uses three but allows evaluation after two when clinically suspicious.
    Documentation requiredLosses should be clinically recognized and documented by ultrasonography or histopathology to meet threshold for evaluation.
    Chromosome analysis cells counted — operational detail
    Cells counted for chromosome analysis (88262)15–20 cells (with 2 karyotypes, with banding)
    Additional cells88285 used to report additional cells counted per study when indicated.
    Parental studies88291 for cytogenetics/molecular cytogenetics interpretation and report for parents when criteria met.
    None in this excerpt — placeholder key/value
    Content noteNo applicable entries in this excerpt.
    ActionNo operational thresholds or items provided in source; block retained as placeholder.
    ReferenceSee policy regulatory and coding sections for related items.

    Prior Authorization, Documentation, and Operational Guidance

    Prior Authorization

    Prior authorization expectations

    Prior authorization may be required when requesting therapies considered medically necessary for specific diagnoses (for example, anticoagulation for antiphospholipid syndrome) or when requesting treatments generally considered experimental; submit supporting evidence of the indication and prior testing when authorization is requested.

    • Submit documentation showing diagnosis-specific indications (e.g., APS) and prior test results.
    • Follow Priority Health Provider Manual and Evicore criteria when prior authorization is required.
    Note

    No prior auth specified in regulatory excerpt

    The regulatory excerpt does not specify formal prior authorization codes or detailed authorization workflows; consult the Priority Health Provider Manual and Evicore via Priority Health Prism for member-specific authorization requirements.

    Note

    Prior authorization — none listed in regulatory excerpt

    This regulatory excerpt contains no explicit prior authorization codes or standalone prior authorization requirements within the FDA/regulatory text; authorization protocols are handled through the plan/provider manual.

    Prior Authorization

    Prior authorization for IVIG (pharmacy criteria)

    Pharmacy authorization criteria apply for intravenous immunoglobulin (IVIG); providers should follow Priority Health drug/pharmacy authorization processes when requesting IVIG.

    • See Priority Health drug information / Pharmacy authorization criteria for IVIG.
    • IVIG is listed among empiric immune‑modulating therapies considered not medically necessary when used solely for immune modulation without documented indication.
    Prior Authorization

    Prior authorization may be required for certain drugs/devices/services

    Prior authorization may be required for certain drugs, devices, services and procedures (including IVIG and G‑CSF); when required, providers must submit medical necessity documentation per plan and Evicore criteria.

    • When prior authorization is required, submit documentation demonstrating medical necessity per the Priority Health Provider Manual and Evicore guidelines.
    • Codes potentially impacted include J1561, J1569, J1572, J1442, J1447, J1449 (see coding section).
    Prior Authorization

    Prior authorization for RPL testing and treatment

    Prior authorization requirements may apply for specific RPL tests and treatments; the policy now explicitly lists which tests/studies and treatments are medically necessary and which are not, and requests for items in the not‑medically‑necessary grouping may be denied.

    • Align submitted testing/treatment requests with the policy’s medically necessary lists; include clinical rationale and supporting results.
    • Requests for tests/therapies designated not medically necessary may be denied if documentation does not show an applicable exception.
    Step Therapy

    Stepwise treatment approach — target identified causes first

    Management should target identified causes (for example, surgical correction for uterine anomalies or aspirin plus heparin for antiphospholipid syndrome) before considering empiric or unproven immune‑modulating therapies.

    • Address modifiable structural and diagnostic causes first (surgery, APS-directed therapy).
    • Avoid empiric immune‑modulating treatments unless diagnosis-specific evidence supports use.
    Note

    No step therapy program specified

    No formal step therapy program requirements are described in this policy; clinical sequencing guidance focuses on treating identified diagnoses before empiric therapies.

    Note

    Prior authorization — none listed (placeholder)

    (Placeholder — no content provided in source.)

    Note

    Provider action placeholder

    (Placeholder — no content provided in source.)

    Note

    Provider action placeholder

    (Placeholder — no content provided in source.)

    Note

    Provider action placeholder

    (Placeholder — no content provided in source.)

    Documentation Required

    Required documentation: clinically recognized losses and targeted evaluation

    Documentation must include clinical evidence of clinically recognized pregnancy losses (ultrasonography or histopathology) meeting the policy thresholds and targeted history/physical and relevant test results to support diagnosis and treatment decisions.

    • Provide ultrasound or pathology reports documenting losses per the policy thresholds (2+ first‑trimester or ≥1 second‑trimester loss).
    • Include focused obstetric, medical, surgical, genetic, and family history and relevant test results used to direct care.
    Note

    FDA status — consult FDA device databases

    For device or test regulatory status, consult the U.S. Food & Drug Administration (FDA) Medical Device Databases for the most current FDA device status information.

    • Policy directs providers to the FDA Medical Device Databases for current regulatory status.
    • FDA identifier fields in the regulatory section are placeholders and should be verified via FDA databases.
    Documentation Required

    Regulatory identifiers (510(k)/PMA/De Novo) missing — supply when requested

    The regulatory section contains placeholders for 510(k), Premarket Approval (PMA), and De Novo identifiers and notice dates but does not provide specific numbers; providers should supply device/test FDA identifiers when requested.

    • Placeholders for 510(k)/PMA/De Novo numbers appear in the policy; no filled identifiers are provided.
    • Provide specific FDA identifiers during authorization or verification requests when applicable.
    Documentation Required

    Documentation — use listed ICD‑10 codes to support medical necessity

    Use the listed ICD‑10 diagnosis codes (for example, N96; O09.21x–O09.29x; O26.20–O26.23; Z31.441) on submitted documentation to support medical necessity for RPL‑related services.

    • Include the most specific ICD‑10 code that matches the patient’s recurrent pregnancy loss history when submitting authorization requests.
    • Codes listed in the policy support documentation of medical necessity for RPL evaluation and management.
    Documentation Required

    Prior authorization documentation — submit medical necessity per plan/Evicore

    When prior authorization is required, providers must submit a request demonstrating medical necessity per the Priority Health Provider Manual and Evicore guidelines (access Evicore via Priority Health Prism).

    • Follow Priority Health Provider Manual submission requirements for prior authorization.
    • To access Evicore criteria: Priority Health Prism → Authorizations → Authorization Criteria Lookup.
    Documentation Required

    Documentation to support medically necessary testing — align with policy lists

    Documentation to support medically necessary testing should align with the policy’s lists of medically necessary versus not medically necessary tests and include clinical justification tying the requested test to the policy criteria.

    • When requesting tests listed as medically necessary, provide clinical indication and relevant supporting results.
    • Avoid requests for tests designated not medically necessary unless clear, policy‑supported exceptions exist and provide supporting evidence.
    Denial Risk

    Denial triggers — requests for tests/therapies listed not medically necessary may be denied

    Requests for diagnostic tests and therapies listed as not medically necessary or experimental (for example, inherited thrombophilia testing performed solely to explain first‑trimester loss, broad immunologic panels, NK cell testing, genetic polymorphism testing, IVIG, G‑CSF, intralipid) may be denied.

    • Do not submit authorization requests for tests/therapies listed as not medically necessary without clear, documented exception criteria.
    • If an excluded test is clinically requested, include justification tied to member‑specific clinical factors and request individual case review where appropriate.
    Note

    No explicit authorization/denial triggers in regulatory excerpt

    The regulatory section itself does not state explicit authorization or denial triggers; it directs users to FDA databases for device status but authorization decisions are handled via plan procedures.

    Documentation Required

    Regulatory identifiers missing — may impede verification

    The regulatory entries for device/test identifiers are unfilled placeholders in this policy; missing FDA identifiers may impede verification during authorization or coverage review and should be supplied if available.

    • Provide FDA 510(k)/PMA/De Novo numbers when known to aid verification.
    • Absent identifiers in the policy mean reviewers may request additional regulatory documentation.
    Prior Authorization

    IVIG authorization reference — follow pharmacy criteria

    Priority Health pharmacy authorization criteria apply to IVIG; follow the plan’s drug authorization process when requesting IVIG for RPL‑related indications.

    • IVIG is listed among empiric immune‑modulating therapies in the policy and pharmacy authorization applies.
    • Consult Priority Health drug information and pharmacy authorization criteria for submission details.
    Denial Risk

    Individual case review — experimental therapies assessed case‑by‑case

    Coverage determinations for experimental, investigational, or unproven treatments (for example, some immunologic or empiric therapies) will be made by a Priority Health medical director or clinical pharmacist on a case‑by‑case basis; individual case review may allow coverage in exceptional circumstances.

    • Requests for experimental/unproven treatments require prior plan approval and will undergo individual review.
    • Exceptions may be considered for terminal, life‑threatening, or severely disabling conditions causing serious clinical deterioration.
    Denial Risk

    Not demonstrated benefit → may trigger denial

    Tests and therapies separated into the not medically necessary grouping were done so because they lack demonstrated clinical benefit; use of these tests/therapies may trigger denial of coverage.

    • Examples include NK cell testing, broad immunologic panels, MTHFR polymorphism testing, IVIG, intralipid, and G‑CSF.
    • Requests for these items should include strong clinical justification and may require individual case review.

    Background and Evidence Summary

    Recurrent pregnancy loss (RPL) definitions vary across societies, but contemporary guidance — and this policy — supports clinical evaluation after two or more clinically recognized first‑trimester pregnancy losses or after one or more second‑trimester losses. Evaluation should include documentation of pregnancy loss (ultrasound or histopathology) and targeted history, physical, and testing directed by identified risk factors.

    Definitions and Regulatory Terms

    Recurrent pregnancy loss (RPL) — definitions across societies (ESHRE, ACOG, RCOG)
    ESHRE definitionLoss of two or more pregnancies (excluding ectopic and molar pregnancies).
    ACOG recommendationSupports clinical evaluation after a second clinically recognized first‑trimester pregnancy loss.
    RCOG positionDefines recurrent miscarriage as three or more first‑trimester losses but allows evaluation after two when clinical suspicion exists.
    FDA regulatory pathways — PMA, De Novo, 510(k) referenced
    FDA regulatory pathways listedPremarket Approval (PMA), 513(f)(2) De Novo, or 510(k).
    Reference instructionSee U.S. Food & Drug Administration (FDA) Medical Device Databases for the most current information on device status.
    Placeholders presentPolicy includes template fields for 510(k)/PMA/De Novo numbers and notice dates (entries are placeholders in the excerpt).
    FDA regulatory identifiers — placeholders for 510(k)/PMA/De Novo identifiers and dates
    510(k)/PMA/De Novo identifiersPolicy contains placeholder fields for 510(k), Premarket Approval (PMA), and De Novo identifiers and notice dates but no specific identifiers are provided in this excerpt.
    Operational implicationMissing FDA identifiers may impede device/test verification during authorization; providers should supply device/test FDA identifiers when requested.
    Where to verifyConsult FDA Medical Device Databases for current identifiers and notice dates.
    N96 and associated obstetric history supervision codes — ICD-10 and related codes referenced
    Primary ICD‑10 code for RPLN96 — Recurrent pregnancy loss.
    Associated obstetric supervision codesO09.211–O09.219; O09.291–O09.299; O26.20–O26.23 — supervision/pregnancy care codes related to poor reproductive or obstetric history.
    Related encounter codeZ31.441 — Encounter for testing of male partner of patient with recurrent pregnancy loss.
    Levothyroxine treatment (T4LIFE trial context) — levothyroxine in euthyroid TPO antibody-positive women
    T4LIFE trialT4LIFE: multicentre, randomized, double‑blind, placebo‑controlled phase 3 trial of levothyroxine in euthyroid TPO antibody‑positive women with recurrent pregnancy loss (van Dijk et al., 2022).
    Systematic review/meta‑analysisA subsequent systematic review and meta‑analysis of randomized trials on levothyroxine in euthyroid pregnant women with TPO antibodies is cited (Provinciatto et al., 2025).
    Policy implicationPolicy notes levothyroxine therapy in euthyroid individuals with thyroid antibodies is listed as not medically necessary in excluded/against recommendations unless evidence supports use.

    Policy Revision History

    2026-06-01Effective dateLatest

    Policy effective date published; reorganized medical necessity criteria and new sections added listing medically necessary and not medically necessary tests/studies for RPL evaluation and treatment.

    2026-05-13Last review

    Clinical content and background updated to incorporate recent randomized trials, meta-analyses, and society guidelines; documentation and prior authorization language clarified.

    2026-05Change summary

    Added new Policy scope, Medical/Professional Society Guidelines, Government Regulations, and FDA/Regulatory sections; added lists of medically necessary and not medically necessary tests/studies for RPL.

    2026-05Removal

    Removed outdated references and legacy content no longer aligned with current evidence.