ModifiedCignaPolicy 0175

In-utero fetal surgery

Defines medical necessity and exclusions for fetal surgery procedures performed in-utero for congenital malformations and who (members of Cigna-administered health plans) this policy applies to.

Policy Summary

PayerCigna

PolicyIn-utero fetal surgery

Policy CodePolicy 0175

Change TypeRemoval of multiple prior policy statements

Effective Date

Next Review DateJul 15, 2025

Key ActionObtain prior authorization for unlisted fetal invasive procedures billed with CPT 59897 and provide documentation that the procedure meets medical necessity criteria.

SourceLink

POLICY UPDATE CHANGES

Removed policy statement for serial amnioreduction for twin-to-twin transfusion syndrome (TTTS).

Removed policy statement for fetoscopic occlusion of anastomotic vessels (e.g., laser photocoagulation, radiofrequency ablation, ligation) for twin reversed arterial perfusion (TRAP sequence).

Removed policy statement for fetal vesicoamniotic shunt procedures for bilateral fetal urinary-tract obstruction.

Removed policy statement for in‑utero needle access and open resection of sacrococcygeal teratoma.

Removed policy statement for fetal thoracoamniotic shunt placement for any of the following indications.

5policy statements removed in this revision

≥19–<26wmyelomeningocele GA window

<26wTTTS laser GA threshold

<30wFETO GA threshold

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Coverage Criteria for In‑Utero Fetal Surgery

This policy lists procedures and indications that are considered not medically necessary when performed in‑utero. Explicit examples include: laser, thermocoagulation, or radiofrequency ablation techniques for sacrococcygeal teratoma; endoscopic (fetoscopic) cystoscopy approaches for lower urinary tract obstruction; amniotic band syndrome; aqueductal stenosis (hydrocephalus); cleft lip and/or cleft palate; congenital heart defects; in‑utero gene therapy; and in‑utero hematopoietic stem‑cell transplantation for stem‑cell related diseases. The policy further states that fetal surgery is considered not medically necessary for any other indication not listed as medically necessary.

Use of minimally invasive energy‑based vessel coagulation techniques (including laser, thermocoagulation, or radiofrequency ablation) to treat sacrococcygeal teratoma or other fetal tumors, and endoscopic approaches such as fetoscopic cystoscopy for lower urinary tract obstruction, are identified in this policy as procedures reported with CPT 59897 when unlisted. When these techniques are used for indications the policy lists as not medically necessary, they are considered not medically necessary and claims may be denied.

During the most recent annual review the policy removed several specific policy statements. These removals affect prior coverage language for a group of fetal procedures and indicate that providers should seek prior authorization because coverage positions for those procedures have changed.

Specific items the policy designates as not medically necessary include: laser, thermocoagulation, or radiofrequency ablation for sacrococcygeal teratoma; fetoscopic cystoscopy (endoscopic approach) for lower urinary tract obstruction; and other procedures listed in the NMN section such as interventions for amniotic band syndrome, aqueductal stenosis, cleft lip/palate, congenital heart defects, and in‑utero gene or stem‑cell therapies. The policy also notes that these procedures are commonly reported using CPT 59897 when billed as unlisted fetal invasive procedures and may be denied if the procedure is one the policy lists as not medically necessary.

This policy aligns with external guidance in noting that several percutaneous fetal procedures have not been proven safe and effective. Examples referenced include percutaneous fetal balloon valvuloplasty for pulmonary atresia or aortic stenosis and percutaneous laser therapy for fetal tumors (NICE), and the document cites that fetoscopic prenatal repair of open neural tube defects remains not established in some guidance, while open prenatal repair has demonstrated benefit in selected situations.

Coding, Gestational Thresholds, and Procedure Codes

CPT codes referencedCPT

59897

Unlisted fetal invasive procedure, including ultrasound guidance, when performed

Myelomeningocele gestational age threshold

Gestational age window>= 19.0 and < 26 weeks

Pregnancy type requirementSingleton pregnancy required for eligibility

Lesion locationUpper boundary of lesion between T1 and S1

TTTS gestational age threshold for laser coagulation

Gestational age thresholdFetal gestational age of less than 26 weeks

Amniotic fluid criteriaEvidence of polyhydramnios in the recipient fetus

Donor fetus criteria

Provider Actions, Prior Authorization, and Billing Guidance

Prior Authorization

Prior authorization and review expectations

Coverage determinations require review of the terms of the applicable benefit plan document in effect on the date of service, any applicable laws/regulations, relevant collateral materials (including Coverage Policies), and the specific facts of the situation. Providers should submit requests with complete documentation to support medical necessity and coding.

When billing, providers must use the most appropriate codes as of the effective date of submission.
Claims submitted without covered diagnosis or procedure codes under the applicable Coverage Policy will be denied.
Providers must document procedures thoroughly and include supporting clinical information when requesting coverage or prior authorization.

Prior Authorization

Prior Authorization Required for Unlisted Fetal Invasive Procedures (CPT 59897)

Prior authorization is required for unlisted fetal invasive procedures reported with CPT 59897. Such requests will be evaluated against the policy's medical necessity criteria and should include documentation demonstrating that the procedure meets those criteria.

Background on In‑Utero Fetal Surgery

In‑utero fetal surgery is performed to correct congenital malformations that threaten organ development or fetal survival. Procedures range from open maternal‑fetal operations to fetoscopic or percutaneous minimally invasive techniques, and are undertaken to improve fetal physiology (for example, reducing hydrops, restoring amniotic fluid dynamics, or promoting pulmonary development). These interventions are typically performed before the late third trimester and are concentrated in specialized multidisciplinary centers with advanced neonatal support.

Definitions and Condition Summaries

Myelomeningocele (spina bifida) summary

DefinitionMyelomeningocele (spina bifida) is a neural-tube defect in which the spinal cord remains open, exposing meninges and neural tissue; may be associated with Arnold-Chiari II malformation and lead to neurologic, orthopedic, and urologic complications.

Clinical consequencesMay result in physical and mental disabilities, extremity deformities, scoliosis, and urinary dysfunction; intrauterine exposure may cause secondary spinal cord injury.

Treatment contextTraditional treatment is postnatal surgical repair and ventriculoperitoneal shunting; in-utero repair is offered to potentially improve neurologic outcomes under specific criteria.

CPAM/CCAM (congenital pulmonary airway malformation) summary

DefinitionCongenital Pulmonary Airway Malformation (CPAM)/CCAM is a benign cystic pulmonary mass that can lead to fetal hydrops and pulmonary hypoplasia; lesions classified as microcystic or macrocystic.

Revision History and Policy Updates

2025-07-15policy_revisionLatest

Removed policy statements for serial amnioreduction for twin-to-twin transfusion syndrome (TTTS); fetoscopic occlusion of anastomotic vessels for twin reversed arterial perfusion (TRAP); fetal vesicoamniotic shunt procedures for bilateral fetal urinary-tract obstruction; in‑utero needle access and open resection of sacrococcygeal teratoma; and fetal thoracoamniotic shunt placement.

Summary of changes from the annual review: the policy removed prior policy statements for five categories of procedures — serial amnioreduction for twin‑to‑twin transfusion syndrome (TTTS); fetoscopic occlusion of anastomotic vessels for TRAP sequence; fetal vesicoamniotic shunt procedures for bilateral urinary‑tract obstruction; in‑utero needle access and open resection of sacrococcygeal teratoma; and fetal thoracoamniotic shunt placement. Because these statements were deleted, providers should obtain prior authorization when requesting these procedures since the coverage positions have changed.

Policy Summary

PayerCigna

PolicyIn-utero fetal surgery

Policy CodePolicy 0175

Change TypeRemoval of multiple prior policy statements

Effective Date

Next Review DateJul 15, 2025

Key ActionObtain prior authorization for unlisted fetal invasive procedures billed with CPT 59897 and provide documentation that the procedure meets medical necessity criteria.

SourceLink

On This Page

Donor fetus is oligohydramniotic

Hemodynamic assessmentEvidence of abnormal blood flow documented by Doppler in one or both fetuses

FETO gestational age threshold for left CDH

Gestational age thresholdFetal gestational age of less than 30 weeks

Pregnancy type requirementSingleton pregnancy required for eligibility

Condition limitationIntended for isolated left congenital diaphragmatic hernia

Severe pulmonary hypoplasia criterion (FETO) — observed-to-expected lung-to-head ratio threshold

Severe pulmonary hypoplasia definitionObserved-to-expected lung-to-head ratio (o/e LHR) < 25%

Exclusion of other defectsNo other major structural or chromosomal defects present

Use contextCriterion applied when considering FETO for isolated left CDH

CPT 59897 — Unlisted fetal invasive procedure, including ultrasound guidance.
Include clinical rationale, diagnostic findings, gestational age, prior conservative treatments attempted (if applicable), and operative details.
Procedures using CPT 59897 that match ones listed as Not Medically Necessary in this policy (e.g., laser, thermocoagulation, radiofrequency ablation for sacrococcygeal teratoma; endoscopic approaches for lower urinary tract obstruction) will be subject to denial or further review.

Documentation Required

Policy Statement Removals — Provider Action Recommended

Removal of prior policy statements for specific procedures indicates those procedures are no longer supported by this policy as covered without review; providers should obtain prior authorization when submitting claims for the affected procedures and supply supporting documentation.

Removed procedures include serial amnioreduction for TTTS; fetoscopic occlusion of anastomotic vessels (e.g., laser photocoagulation, radiofrequency ablation, ligation) for TRAP sequence; fetal vesicoamniotic shunt procedures for bilateral fetal urinary-tract obstruction; in-utero needle access and open resection of sacrococcygeal teratoma; and fetal thoracoamniotic shunt placement.
Providers should request prior authorization for these procedures and attach clinical documentation supporting medical necessity.

Prior Authorization

Prior Authorization Likely Required for Procedures with Removed Statements

Providers should be aware that prior authorization is likely required for procedures previously addressed in removed policy statements; obtain prior authorization as applicable and include complete clinical documentation with the request.

Documentation Required

Documentation and Coding Requirements for CPT 59897

Claims for unlisted fetal invasive procedures reported with CPT 59897 must include documentation demonstrating that the procedure meets the policy's medical necessity criteria. Use the most appropriate CPT/diagnosis codes and supply operative reports, imaging, and clinical notes as needed.

Failure to supply covered diagnosis or procedure codes and supporting documentation may result in denial.
Use current CPT codes; deleted or inactive codes may not be eligible for reimbursement.

Denial Risk

Billing Risk — CPT 59897 for Not Medically Necessary Procedures

Use of CPT 59897 to report procedures that this policy describes as not medically necessary will be subject to denial or additional review. Providers should verify policy coverage and obtain prior authorization when indicated before performing such procedures.

Examples of techniques considered not medically necessary when reported with CPT 59897 include laser, thermocoagulation, radiofrequency ablation for sacrococcygeal teratoma and endoscopic (cystoscopic) treatment for lower urinary tract obstruction.

Clinical riskLarge lesions may cause mediastinal shift, fetal hydrops, pulmonary hypoplasia and persistent pulmonary hypertension; mortality approaches 100% when CPAM occurs with fetal hydrops.

Intervention criterionFetal lobectomy considered when evidence of fetal hydrops and large multicystic or predominantly solid lesions are present.

Sacrococcygeal teratoma (SCT) — summary and clinical significance

DefinitionSacrococcygeal teratoma (SCT) is a tumor derived from more than one embryonic germ layer; most are benign but malignancy risk increases with age.

Clinical significanceSCTs can be highly vascular, cause vascular shunting, high-output cardiac failure and fetal hydrops; untreated high-output failure with hydrops can result in 100% fetal mortality.

Treatment contextStandard treatment is complete excision after birth; when diagnosed prenatally with hydrops or high-output failure, early in-utero intervention (needle access/open resection) or minimally invasive vessel-ablation techniques have been attempted but outcomes vary.

Sacrococcygeal teratoma (SCT) — tumor description

Tumor descriptionTumor derived from multiple embryonic germ layers, often located at the sacrococcygeal region; vascularity can be prominent.

Usual courseMost SCTs are benign; risk of malignancy increases with age; can cause uterine enlargement and polyhydramnios leading to prenatal detection.

Intervention rationaleInterventions aim to reduce tumor blood flow and reverse hydrops via excision or vessel ablation techniques.

Aqueductal stenosis summary (congenital hydrocephalus)

DefinitionAqueductal stenosis is obstruction of the aqueduct of Sylvius causing congenital hydrocephalus with ventricular dilation and potential brain compression.

Clinical consequenceObstruction dilates ventricles and may compromise brain function; outcomes after early shunting have been poor.

Treatment guidanceIn-utero ventriculoamniotic shunting has not improved perinatal outcomes and early shunting is not recommended until at least 32 weeks; a moratorium on percutaneous shunting remains in effect since 1985.

Congenital diaphragmatic hernia (CDH) summary and prognosis context

DefinitionCongenital diaphragmatic hernia (CDH) is a defect allowing abdominal viscera into the chest cavity, frequently causing pulmonary hypoplasia and pulmonary hypertension.

Prognostic factorsPrognosis depends on liver herniation, presence of other anomalies, and lung-to-head ratio; without intervention many infants die due to underdeveloped lungs.

Intervention contextFetoscopic endoluminal tracheal occlusion (FETO) may be considered for isolated left CDH with severe pulmonary hypoplasia (o/e LHR <25%) in singleton pregnancies <30 weeks to promote lung growth, though open fetal surgery has not shown advantage and carries high maternal-fetal risk.

Key referenced guidance and studies — cited guidance and registry sources

NICE guidanceNICE IPG198, IPG613, IPG667, IPG668 are cited as relevant interventional procedure guidance referenced in the policy.

Key studiesRandomized and systematic studies on FETO and myelomeningocele (e.g., Ruano et al., randomized trial of FETO; Adzick et al. on MMC) are referenced.

Registry and reviewsSystematic reviews and meta-analyses (e.g., Provinciatto et al. 2024; Van Mieghem et al. 2014) and registries informing survival and outcomes are cited.