ModifiedWellCarePolicy CP.MP.129

Fetal Surgery in Utero for Prenatally Diagnosed Malformations

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Defines medical necessity criteria and coding references for performing in-utero fetal surgery for specific prenatally diagnosed fetal malformations for members of WellCare/Centene-affiliated health plans.

Policy Summary

PayerWellCare

PolicyFetal Surgery in Utero for Prenatally Diagnosed Malformations

Policy CodePolicy CP.MP.129

Change TypeMultiple material revisions (criteria added/updated/removed)

Effective Date

Next Review Date

Key ActionObtain prior authorization referencing the medical necessity criteria; note that all repeat uterine fetal surgeries require secondary review.

SourceLink

POLICY UPDATE CHANGES

Under I.A. added 'with treatment including' and criteria for correction via a minimally invasive approach and SCT resection when specific conditions are met.

Criteria I.G.3. updated to require confirmation on fetal MRI and clarifying language added to Criteria I.G.4.

Criteria I.G.6. updated to maternal body mass index of ≥ 40 and supportive references added.

Added requirement that all repeat utero fetal surgery procedures require secondary review.

Quantified criterion I.F.5.c. to include (≥30 degrees).

Added criteria I.G. Fetal endoscopic tracheal occlusion (FETO) for congenital diaphragmatic hernia when all of the following are met: Severe left-sided CDH; Severe pulmonary hypoplasia defined as observed-to-expected lung-to-head ratio <25%; Gestational age ≤ 30 weeks.

Removed indication I.F.5 and removed III.A. Open or endoscopic fetal surgery for congenital diaphragmatic hernia (CDH), including temporary tracheal occlusion.

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ModifiedWellCarePolicy CP.MP.129

Fetal Surgery in Utero for Prenatally Diagnosed Malformations

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Policy Summary

PayerWellCare

PolicyFetal Surgery in Utero for Prenatally Diagnosed Malformations

Policy CodePolicy CP.MP.129

Change TypeMultiple material revisions (criteria added/updated/removed)

Effective Date

Next Review Date

Key ActionObtain prior authorization referencing the medical necessity criteria; note that all repeat uterine fetal surgeries require secondary review.

SourceLink

POLICY UPDATE CHANGES

Under I.A. added 'with treatment including' and criteria for correction via a minimally invasive approach and SCT resection when specific conditions are met.

Criteria I.G.3. updated to require confirmation on fetal MRI and clarifying language added to Criteria I.G.4.

Criteria I.G.6. updated to maternal body mass index of ≥ 40 and supportive references added.

Added requirement that all repeat utero fetal surgery procedures require secondary review.

Quantified criterion I.F.5.c. to include (≥30 degrees).

Removed indication I.F.5 and removed III.A. Open or endoscopic fetal surgery for congenital diaphragmatic hernia (CDH), including temporary tracheal occlusion.

IPrimary covered indication groups

19–25 wksMyelomeningocele GA window

≤30wMax GA for FETO

<25%O/E LHR threshold (FETO)

59001,59072,59076,59897CPT codes referenced

MultipleEvidence sources

Medical Necessity Criteria

inv-01: Medically Necessary Indications

Covered when the following indication-specific requirements are met

I.A Sacrococcygeal teratoma (SCT): SCT with treatment including correction via a minimally invasive approach OR SCT resection when ALL of the following are met: fetuses with high-risk SCT and hydrops developing at a gestational age earlier than appropriate for delivery and neonatal care (e.g., 28-32 weeks gestation); does not have contraindications: (i) Type III or IV Altman-type tumors; (ii) Severe placentomegaly; (iii) Maternal cervical shortening.

Introduced/clarified in recent revisions.

I.B Lower urinary tract obstruction: Lower urinary tract obstruction without multiple fetal anomalies or chromosomal abnormalities: urinary decompression via vesico-amniotic shunting.

I.C CPAM and extralobar BPS: Congenital pulmonary airway malformation (CPAM) and extralobar bronchopulmonary sequestration (BPS) with high-risk tumors: resection of malformed pulmonary tissue, or placement of a thoraco-amniotic shunt.

I.D Pleural effusion with/without hydrops: Placement of a thoraco-amniotic shunt for pleural effusion with or without secondary fetal hydrops.

I.E Twin-twin transfusion syndrome (TTTS): Treatment dependent on Quintero stage, maternal signs/symptoms, gestational age and local expertise and include amnioreduction OR fetoscopic laser ablation (with or without amnioreduction) when pregnancy is between 16 and 26 weeks gestation.16-26 weeks for laser ablation

I.F TRAP sequence: Twin-reversed-arterial-perfusion sequence (TRAP): ablation of anastomotic vessels of the acardiac twin (e.g., laser, radiofrequency ablation).

I.G Myelomeningocele repair: Repair when ALL of the following are met: singleton pregnancy; upper boundary of lesion between T1 and S1; evidence of hindbrain herniation confirmed on fetal MRI; gestational age between 19 0/7 and 25 6/7 weeks; none of the following contraindications: severe kyphosis (≥30 degrees); risk of preterm birth (e.g., short cervix or previous preterm birth); placental abruption; maternal body mass index of ≥ 40; previous hysterotomy in the active uterine segment.gestational age 19 0/7–25 6/7 weeks; kyphosis ≥30 degrees; BMI ≥40

Imaging confirmation via fetal MRI required.

I.H FETO for CDH: Fetal endoscopic tracheal occlusion (FETO) for congenital diaphragmatic hernia when ALL of the following are met: severe left-sided CDH; severe pulmonary hypoplasia defined as observed-to-expected lung-to-head ratio (O/E LHR) < 25%; gestational age ≤ 30 weeks.O/E LHR <25%; gestational age ≤30 weeks

Added to policy as criteria I.G; exact numbering per policy document.

inv-02: FETO (I.G) eligibility

Fetal endoscopic tracheal occlusion (FETO) for congenital diaphragmatic hernia is included when ALL of the following are met:

FETO for CDH eligibility: Severe left-sided congenital diaphragmatic hernia (CDH); severe pulmonary hypoplasia defined as an observed-to-expected lung-to-head ratio (O/E LHR) of less than 25%; gestational age ≤ 30 weeks.O/E LHR <25%; GA ≤30 weeks

Criterion added in recent revision; procedures must meet all elements.

Current evidence does not support the use of in‑utero fetal surgery for specific indications. Examples explicitly listed in the policy include surgery for heart block, pulmonary valve or aortic obstruction, tracheal atresia or stenosis, cleft lip and palate, in‑utero stem cell transplantation, in‑utero gene therapy, and amnioexchange procedure for gastroschisis. Procedures for these indications are considered unsupported by the evidence and are not covered under this policy.

The policy revision removes open or endoscopic fetal surgery for congenital diaphragmatic hernia (CDH), including temporary tracheal occlusion, from the list of covered indications. The document history notes that III.A (open or endoscopic fetal surgery for CDH, including temporary tracheal occlusion) was removed, and the policy now defines more specific criteria for endoscopic tracheal occlusion (FETO) under a separate covered criterion when all enrollment conditions are met.

Document history shows a prior non‑covered (NMN) stance for certain CDH procedures was changed in this revision. Specifically, open or endoscopic fetal surgery for CDH (including temporary tracheal occlusion) was removed from the non‑covered list and FETO was added as a covered option under defined eligibility criteria, reflecting a shift from blanket non‑coverage to a conditional coverage approach.

The revision removed one previously listed indication (I.F.5) and deleted language requiring a normal fetal karyotype. The change log highlights that indication I.F.5 was removed and that the previously stated requirement for a normal fetal karyotype is no longer included in the policy.

Applicable Codes & Key Thresholds

CPT Codes referencedCPT

59001	Amniocentesis; therapeutic amniotic fluid reduction (includes ultrasound guidance)
59076	Fetal shunt placement, including ultrasound guidance
59897	Unlisted fetal invasive procedure, including ultrasound guidance, when performed
59072	Fetal umbilical cord occlusion, including ultrasound guidance

HCPCS Codes referencedHCPCS

S2401	Repair, urinary tract obstruction in the fetus, procedure performed in utero.
S2402	Repair, congenital cystic adenomatoid malformation in the fetus, procedure performed in utero.
S2403	Repair, extralobar pulmonary sequestration in the fetus, procedure performed in utero.
S2404	Repair, myelomeningocele in the fetus, procedure performed in utero.
S2405	Repair of sacrococcygeal teratoma in the fetus, procedure performed in utero.
S2409	Repair congenital malformation of fetus, procedure performed in utero, not otherwise classified.
S2411	Fetoscopic laser therapy for treatment of twin-to-twin transfusion syndrome

Gestational age window for myelomeningocele repair

Gestational age window19 0/7 to 25 6/7 weeks

Policy contextRequired for myelomeningocele repair per coverage criteria I.G

Documentation neededGestational age must be documented in clinical record and fetal MRI confirmation per criteria

Gestational age limit for FETO in severe CDH

Maximum gestational age≤ 30 weeks

IndicationApplies to FETO for severe left-sided congenital diaphragmatic hernia (CDH)

Authorization, Documentation & Denial Risk

Prior Authorization

Obtain prior authorization; repeat procedures need secondary review

Prior authorization is required for in-utero fetal surgery and requests should reference the policy's medical necessity criteria for the specific indication. All repeat utero fetal surgery procedures require secondary review.

Prior authorization must cite the applicable indication-specific criteria (e.g., myelomeningocele, FETO eligibility).
Secondary review is required for any repeat utero fetal surgery procedure.

Prior Authorization

Verify benefits and plan-level coverage terms

Verify member benefits and plan-level terms before submitting an authorization: coverage decisions are subject to the member's evidence of coverage, exclusions, limitations, and applicable Health Plan administrative policies and procedures.

Confirm applicability of this clinical policy to the member's specific plan and contract.
Check for plan exclusions or limitations that may affect coverage determinations.

Policy Background

Maternal‑fetal surgery encompasses two principal approaches: open fetal surgery, which involves a maternal hysterotomy with partial exteriorization of the fetus to perform corrective repair, and fetoscopic (minimally invasive) surgery, which uses small fiberoptic instruments inserted through the uterine wall to correct fetal malformations without full exteriorization. These procedures carry maternal and fetal risks, often increase the likelihood of preterm birth, and should be performed only at centers with multidisciplinary fetal therapy expertise.

Key Definitions

Open fetal surgery — definition

DefinitionOpen fetal surgery involves performing a hysterotomy, partially exteriorizing the fetus to expose and correct the abnormality, then returning the fetus to the uterus

Indication contextConsidered when the fetal condition is life threatening and intervention is the only option for fetal survival

Clinical implicationsMajor procedure with significant maternal and fetal risks; typically performed at specialized centers

Fetoscopic surgery — definition

DefinitionFetoscopic surgery is a minimally invasive fetal surgical approach using small fiberoptic telescopes and instruments entering the uterus through small openings to correct malformations without major incisions or exteriorizing the fetus

Clinical benefit

Policy Summary

PayerWellCare

PolicyFetal Surgery in Utero for Prenatally Diagnosed Malformations

Policy CodePolicy CP.MP.129

Change TypeMultiple material revisions (criteria added/updated/removed)

Effective Date

Next Review Date

Key ActionObtain prior authorization referencing the medical necessity criteria; note that all repeat uterine fetal surgeries require secondary review.

SourceLink

On This Page

Added as quantified FETO eligibility in policy revisions

Observed-to-expected lung-to-head ratio (O/E LHR)

O/E LHR thresholdObserved-to-expected lung-to-head ratio (O/E LHR) < 25%

UseDefines severe pulmonary hypoplasia for FETO eligibility in CDH cases

Metric typeQuantitative prenatal metric used to assess pulmonary hypoplasia severity

Gestational age for FETO

Gestational age limit (emphasis)≤ 30 weeks

ContextRepeated as a key eligibility threshold for fetal endoscopic tracheal occlusion (FETO)

Policy revisionCriteria specifying GA ≤ 30 weeks were added in recent policy update

Angular criterion (I.F.5.c)

Angular criterion≥ 30 degrees

ApplicationSpecified as quantified criterion for severe kyphosis in I.F.5.c (contraindication for certain fetal procedures)

Policy changeCriterion (≥30 degrees) was newly quantified in the revision

Billing Rule

Include precise procedural codes and prior-auth references on requests/claims

Document procedural coding precisely and include any required prior-authorization reference numbers when submitting claims or authorization requests.

Use the CPT/HCPCS codes referenced by the policy when applicable (e.g., 59001, 59072, 59076, 59897; S2401–S2411).
Include the prior authorization identifier on claim submissions to facilitate adjudication.

Note

Document center expertise and risk considerations

Coordinate care at centers with appropriate multidisciplinary fetal therapy expertise as procedures carry maternal and fetal risks and often result in preterm birth; document center capability if relevant to the authorization request.

Provide evidence of the treating center's multidisciplinary fetal therapy expertise when requested.
Document considerations of maternal and fetal risk that informed the decision to pursue IUFS.

Documentation Required

Provide complete clinical documentation demonstrating criteria are met

Clinical documentation must demonstrate that all medical necessity criteria for the chosen indication are met, including required imaging and gestational age documentation.

For myelomeningocele repair: include fetal MRI confirmation of hindbrain herniation and gestational age within 19 0/7–25 6/7 weeks.
For FETO: include measured O/E LHR (<25%) and gestational age ≤ 30 weeks, as applicable.

Documentation Required

Adhere to plan, state Medicaid, and Medicare precedence rules

Follow applicable coverage documents and applicable state Medicaid or Medicare NCD/LCD rules; where state Medicaid or Medicare provisions conflict, those provisions take precedence.

Review state Medicaid manuals and relevant NCDs/LCDs prior to applying the policy criteria.
Exercise professional medical judgment but ensure documentation aligns with the member's plan terms and any overriding legal/regulatory requirements.

Denial Risk

Risk of denial if indication criteria are unmet

Procedures that do not meet the policy's specified indication criteria are subject to denial as not medically necessary.

Examples include failure to meet myelomeningocele criteria (e.g., gestational age or imaging confirmation) or TTTS outside the specified staging/gestational windows.
Incomplete documentation of required criteria may lead to denial.

Denial Risk

Denial risk for procedures removed from coverage (e.g., CDH surgeries)

Requests or claims for procedures that were removed from coverage—such as open or endoscopic fetal surgery for CDH including temporary tracheal occlusion—may be denied if submitted inconsistent with the updated policy.

FETO is covered only when the policy's FETO-specific criteria are met; prior non-covered listings for CDH procedures were removed and now trigger denial if billed outside criteria.
Ensure the submitted indication matches the currently allowed FETO criteria (e.g., severe left-sided CDH with O/E LHR <25% and GA ≤30 weeks).

Less traumatic than open surgery and may reduce risk of preterm labor

SettingPerformed at centers with multidisciplinary fetal therapy expertise

FETO — definition

DefinitionFetal endoscopic tracheal occlusion (FETO) is an endoscopic procedure that occludes the fetal trachea to promote lung growth in severe congenital diaphragmatic hernia

IndicationUsed to treat severe left-sided CDH with severe pulmonary hypoplasia when criteria are met

EvidenceReferenced in policy and supported by clinical literature on fetoscopic tracheal occlusion

Observed-to-expected lung-to-head ratio (O/E LHR) — definition and usage in CDH assessment

DefinitionObserved-to-expected lung-to-head ratio (O/E LHR) is a quantitative prenatal metric used to assess pulmonary hypoplasia severity in fetuses with congenital diaphragmatic hernia

Policy usePolicy uses O/E LHR < 25% to define severe pulmonary hypoplasia for FETO eligibility

Clinical roleUsed to stratify severity and guide candidacy for fetal interventions such as FETO