CurrentAetnaPolicy 0657

Tubal Sterilization

Defines Aetna's coverage stance for tubal sterilization methods (e.g., ring, clips, partial/total salpingectomy) and identifies procedures considered experimental/investigational; applies to Aetna members and providers submitting claims for sterilization procedures.

Policy Summary

PayerAetna

PolicyTubal Sterilization

Policy CodePolicy 0657

Change TypeRoutine review — no material changes

Effective DateApr 25, 2003

Next Review DateJul 11, 2024

Key ActionObtain hysterosalpingogram about 3 months after hysteroscopic insert placement to verify tubal occlusion.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

5medically necessary procedures

2investigational systems named

98%Essure 2‑yr efficacy

~15 minsextra operative time (salpingectomy)

65%potential OBS ovarian cancer risk reduction

Coverage Criteria

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Medically Necessary Procedures

Aetna considers the following procedures medically necessary for tubal ligation sterilization:

Medically necessary procedures: 1. Falope ring; 2. Filshie clip (titanium clip); 3. Hulka-Clemens clip; 4. Partial salpingectomy (e.g., Pomeroy technique, Parkland technique); 5. Total salpingectomy (bilateral or complete salpingectomy)

Listed as medically necessary in policy

Experimental and Investigational

The following interventions are considered experimental and investigational for birth control and other indications because safety and long-term effects have not been established:

Investigational procedures: Hysteroscopic tubal sterilization/transcervical sterilization (e.g., Essure Micro-Insert); FemBloc permanent contraceptive system; (Adiana production discontinued by manufacturer)

Listed as experimental/investigational and corresponding HCPCS/CPT codes are identified as not covered

Specific billing codes addressed in this policy include CPT codes 0567T and 58565, which are identified as not covered for the indications in this Clinical Policy Bulletin, and HCPCS code A4264 (Essure microinsert) which is also not covered for the indications listed. Related procedure codes called out in the policy include CPT 58353 (endometrial ablation — noted as not covered when performed at the same time as hysteroscopic sterilization) and CPT 58670 (laparoscopy with fulguration of oviducts). ICD-10 code Z30.2 (encounter for sterilization) is listed as covered if selection criteria are met; a set of ICD-10 diagnosis codes (for example, E23.0, N70.11–N70.13, N97.0–N97.9, and Z31.83) are listed as not covered for the indications in this bulletin.

Device labeling for hysteroscopic micro-insert systems and ACOG recommendations advise against performing radiofrequency endometrial ablation on the same day as hysteroscopic sterilization because ablation significantly decreases the success rate of sterilization and may produce intrauterine synechiae that can compromise confirmation testing; when confirmation testing is inadequate, patients cannot rely on the hysteroscopic implant for contraception.

Hysteroscopic tubal sterilization is contraindicated in any woman who can have only an occlusion device placed (for example, apparent contralateral proximal tubal occlusion or a suspected unicornuate uterus), who has previously undergone tubal ligation, or who is uncertain about ending fertility. Additional contraindications include active or recent pelvic infection, delivery or termination less than 6 weeks prior to device placement, known allergy to contrast media, and pregnancy or suspected pregnancy.

This portion of the Clinical Policy Bulletin provides legal and administrative information and is intended to assist in administering plan benefits; it does not, by itself, define coverage criteria, guarantee coverage, or constitute a contract or medical advice. Treating providers remain responsible for medical care and should refer to plan documents and member benefits for definitive coverage determinations.

Hysteroscopic/transcervical permanent implant sterilization procedures (examples include Essure and other micro‑insert systems or biopolymer intratubal implants) are characterized in this bulletin as experimental and investigational for birth control and other indications and are identified with corresponding CPT/HCPCS codes as not covered. In addition, device labeling and professional guidance note specific clinical considerations (for example, avoidance of same‑day endometrial ablation and the need for post‑placement confirmation testing) and list clinical contraindications that limit patient eligibility.

Coding

Covered CPT Codes (if selection criteria met)CPTCovered

58340	Catheterization and introduction of saline or contrast material for saline infusion sonohysterography (SIS) or hysterosalpingography [three months after hysteroscopic tubal sterilization to verify insert placement and tubal occlusion]
58600	Ligation or transection of fallopian tube(s), abdominal or vaginal approach, unilateral or bilateral [Pomeroy technique, Falope ring, Filshie clip, Hulka-Clemens clip]
58605	Ligation or transection of fallopian tube(s), abdominal or vaginal approach, postpartum, unilateral or bilateral, during same hospitalization (separate procedure) [Pomeroy technique, Falope ring, Filshie clip, Hulka-Clemens clip]
58611	Ligation or transection of fallopian tube(s) when done at the time of cesarean delivery or intra-abdominal surgery (not a separate procedure) (List separately in addition to code for primary procedure) [Pomeroy technique, Falope ring, Filshie clip, Hulka-Clemens clip]
58615	Occlusion of fallopian tube(s) by device (e.g., band, clip, Falope ring) vaginal or suprapubic approach
58661	Laparoscopy, surgical; with removal of adnexal structures (partial or total oophorectomy and/or salpingectomy)
58671	Laparoscopy, surgical; with lysis of adhesions with occlusion of oviducts by device (eg, band, clip, or Fallope ring) [Pomeroy technique, Filshie clip, Hulka-Clemens clip]
58700	Salpingectomy, complete or partial, unilateral or bilateral (separate procedure)
74740	Hysterosalpingography, radiological supervision and interpretation [three months after hysteroscopic tubal sterilization to verify insert placement and tubal occlusion]

CPT Codes not covered for indications listedCPTNot Covered

0567T	Permanent fallopian tube occlusion with degradable biopolymer implant, transcervical approach, including transvaginal ultrasound
58565	Hysteroscopy, surgical; with bilateral fallopian tube cannulation to induce occlusion by placement of permanent implants

Other related CPT CodesCPT

58353	Endometrial ablation, thermal, without hysteroscopic guidance [Not covered when performed at the same time as hysteroscopic sterilization]
58670	Laparoscopy, surgical; with fulguration of oviducts (with or without transection)

ICD-10 covered if selection criteria are metICD-10Covered

Z30.2

Encounter for sterilization

HCPCS not covered for indications listedHCPCSNot Covered

A4264

Permanent implantable contraceptive intratubal occlusion device(s) and delivery system [Essure microinsert]

ICD-10 codes not covered or contraindicated for this CPBICD-10Not Covered

E23.0	Hypopituitarism [Patient undergoing in vitro fertilization cycle]
N70.11	Chronic salpingitis and oophoritis [hydrosalpinx]
N70.12	Chronic salpingitis and oophoritis [hydrosalpinx]
N70.13	Chronic salpingitis and oophoritis [hydrosalpinx]
N97.0	Female infertility [Patient undergoing in vitro fertilization cycle]
N97.9	Female infertility [Patient undergoing in vitro fertilization cycle]
Z31.83	Encounter for assisted reproductive fertility procedure cycle [Patient undergoing in vitro fertilization cycle]
N73.0	Parametritis and pelvic cellulitis
N73.2	Parametritis and pelvic cellulitis
N73.3	Female pelvic peritonitis

1–10 of 17

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inv-14: Hysterosalpingogram timing — recommended 3 months after hysteroscopic tubal sterilization

Recommended timingHysterosalpingogram (HSG) is required approximately 3 months after hysteroscopic tubal sterilization to verify micro-insert placement and tubal occlusion.

PurposeVerify insert placement and confirm tubal occlusion following hysteroscopic micro-insert placement.

Reference in labelingPer device labeling, HSG at 3 months is necessary to confirm successful occlusion.

Implication for coding/documentationHSG procedure codes (e.g., 74740; saline/contrast procedures) are used for the 3-month confirmation imaging.

Provider Actions & Operational Notes

Note

Essure availability and adverse event reporting

Essure (hysteroscopic/transcervical permanent implant) is not available for new implantation in the U.S.; Bayer voluntarily stopped distribution December 31, 2018, and the manufacturer/FDA have confirmed return of known unused devices. Reportable adverse events (AEs) related to Essure should continue to be submitted per FDA guidance — providers should follow applicable post-market AE reporting obligations and consult FDA/Bayer communications for current instructions.

Essure (Essure Micro-Insert) and similar hysteroscopic/transcervical permanent implant devices are listed as experimental/not covered for sterilization.
Bayer stopped selling/distributing Essure in the U.S. on 12/31/2018; FDA continues to monitor post-market safety and has directed submission of reportable AEs.
Providers should report any Essure-related AEs per FDA adverse event reporting procedures.

Prior Authorization

Preauthorization, step-therapy, and policy review note

This policy does not list any plan-specific prior authorization or step-therapy requirements for tubal sterilization procedures. Providers should verify member-specific benefit coverage and any preauthorization needs with the member’s plan prior to scheduling.

No preauthorization requirements are stated in the policy for tubal sterilization.
No step therapy or utilization management requirements are specified.

Denial Risk

Not covered device/technique (hysteroscopic/transcervical implants)

Hysteroscopic/transcervical permanent implant techniques (e.g., Essure, FemBloc, Adiana) are considered experimental/investigational and are not covered by this policy.

Listed not-covered/experimental devices: Essure Micro-Insert (A4264), FemBloc, Adiana (manufacturing discontinued).
Relevant CPT codes for transcervical implant procedures are listed as not covered (e.g., 0567T, 58565).

Documentation Required

Authorization/denial triggers — none specified

No specific authorization or denial triggers are provided in the Clinical Policy Bulletin. Decisions should be based on documented medical necessity, coverage terms in the member’s plan, and the policy’s medically necessary vs experimental/investigational distinctions.

Policy does not specify authorization/denial trigger thresholds or automated triggers.
Use medical necessity criteria (covered procedures listed) and exclusions/contraindications in Appendix to support decisions.

Note

Procedure selection guidance — consider complete salpingectomy and patient counseling

When selecting a sterilization approach, consider complete (bilateral) salpingectomy as an option for patients undergoing pelvic surgery or seeking permanent sterilization. Counsel patients on risks/benefits, including potential ovarian cancer risk reduction with salpingectomy, impact on ovarian function, and alternatives (clips, rings, partial salpingectomy, or non-surgical contraception).

Complete salpingectomy may be offered opportunistically during hysterectomy or other pelvic surgery for benign disease to reduce ovarian cancer risk — discuss with patient.
Discuss informed consent including oophorectomy considerations and surgical route; salpingectomy appears safe and does not increase common surgical complications compared with alternatives.

Documentation Required

Post-procedure verification and imaging confirmation (HSG as reference standard)

Operational note for providers: ensure post-procedure imaging confirmation as required by device labeling and policy when hysteroscopic implants are used (if applicable). Specifically, a hysterosalpingogram (HSG) at about 3 months is the reference-standard test to verify insert placement and tubal occlusion. If HyFoSy is used and suggests occlusion, confirm with HSG because concordance is not perfect.

Labeling for Essure recommends HSG approximately 3 months after placement to verify position and occlusion (CPT 58340, 74740 referenced).
HyFoSy may be less invasive but should be confirmed by HSG when tubal occlusion is indicated by HyFoSy.
Avoid concurrent endometrial ablation on the same day as hysteroscopic sterilization — ablation can increase unsatisfactory HSG rates and compromise confirmation.

Denial Risk

Contraindications for hysteroscopic tubal sterilization

Contraindications and device-specific selection warnings should be observed: hysteroscopic tubal sterilization is contraindicated in patients with prior tubal ligation, inability to place device bilaterally, ongoing pelvic infection, known allergy to contrast, recent delivery/termination (within 6 weeks), pregnancy or uncertainty about fertility desires, and other listed contraindications.

Do not perform hysteroscopic tubal sterilization in women who cannot have bilateral device placement or who previously had tubal ligation.
Contraindications include active/recent pelvic infection, delivery/termination <6 weeks, contrast allergy, pregnancy or suspected pregnancy, or uncertainty about completing childbearing.

Denial Risk

Concurrent endometrial ablation increases risk of unsatisfactory confirmation

Operational warning: performing radiofrequency endometrial ablation on the same day as hysteroscopic sterilization increases the likelihood of an unsatisfactory confirmation test (HSG) and is discouraged per ACOG and device labeling.

Same-day endometrial ablation significantly increases unsatisfactory HSG rates and may prevent reliable confirmation of tubal occlusion.
Device labeling and ACOG advise against concomitant ablation and Essure placement.

Note

Resource links and administrative aids

Provider resources and links: use the policy appendix, Aetna program provisions, plan disclosures, FAQs, and the Aetna glossary or website resources for administrative guidance and member-specific questions.

Refer to Aetna glossary, program provisions, plan disclosures, and FAQs for benefit and administrative questions.
Contact payer/plan for member-specific preauthorization or coverage verification when in doubt.

Definitions

inv-31: Essure micro-insert system — definition and mechanism of action

DefinitionA hysteroscopic, non-incisional tubal sterilization method in which one micro-insert is placed into the proximal lumen of each fallopian tube; the insert expands to anchor and elicits benign tissue in-growth that occludes the tube.

Mechanism of actionInsert expands on release to anchor in the tube and stimulates tissue in-growth into the micro-insert, producing occlusion of the fallopian tube lumen.

Post-procedure requirementLabeling indicates a hysterosalpingogram is necessary about 3 months after placement to verify micro-insert position and tubal occlusion.

inv-32: Partial salpingectomy (Parkland/Pomeroy) — definition and typical use for postpartum sterilization

DefinitionSurgical removal of a portion of the fallopian tube (examples: Parkland or modified Pomeroy techniques) commonly used for postpartum sterilization.

Typical usePreferred and time-efficient methods for postpartum sterilization; Pomeroy and Parkland methods are commonly performed during the same hospitalization after delivery.

Safety/efficacy summaryCochrane review concluded partial salpingectomy, clips, rings, and electrocoagulation are safe and effective with rare major morbidity and low failure rates at 12 months.

inv-33: Total salpingectomy (bilateral/complete) — definition and role as sterilization and opportunistic ovarian cancer risk-reduction procedure

DefinitionComplete removal of the fallopian tubes (bilateral/complete salpingectomy) performed as a method of permanent sterilization.

Role as sterilizationCan be offered as an alternative to tubal ligation; randomized trial showed feasibility though operative time is longer (about 15 minutes more on average) and completion rates may be lower than tubal ligation in some settings.

Opportunistic ovarian cancer risk-reductionOBS (removal of both tubes during benign surgery) is proposed to reduce epithelial ovarian cancer risk (potential reduction cited up to ~65%) and is being discussed in guidelines and consensus statements.

inv-34: FemBloc — definition and note on pivotal trial planning/status

DefinitionA non-surgical, office-based permanent contraceptive system that uses a temporary biopolymer instilled into the tubes to trigger a wound-healing response and permanent closure by the patient’s scar tissue.

Regulatory / trial statusA pivotal trial (BLOC) was initiated in January 2018 to establish efficacy and safety; the BLOC trial required treatment of at least 500 FemBloc patients; FemBloc is not commercially available.

Key trial endpointsPrimary endpoints include pregnancy rate at 1 year and successful confirmation at 3 months; secondary endpoints include safety, satisfaction, and long-term follow-up.

inv-35: Opportunistic bilateral salpingectomy (OBS) — definition and proposed benefit for ovarian cancer risk reduction

DefinitionRemoval of both fallopian tubes performed opportunistically during benign gynecologic or obstetric surgery (OBS).

Proposed benefitSuggested to reduce the risk of epithelial ovarian cancer by removing tubal tissue that may be the origin of some ovarian cancers; studies and consensus statements estimate potential risk reduction and recommend counseling patients without child wish accordingly.

Implementation considerationsOBS is feasible and generally safe with a modest increase in operative time; professional groups recommend counseling and consideration of OBS during abdominal procedures when child-bearing is complete.

inv-36: Hysteroscopic tubal sterilization — definition and contraindications summary

DefinitionTranscervical procedure that places an intrafallopian implant or occlusion device via hysteroscopy (examples include Essure and previously Adiana) to induce tubal occlusion.

Contraindications (summary)Contraindicated for women who can have only an occlusion device placed (e.g., suspected contralateral proximal tubal occlusion or unicornuate uterus), have prior tubal ligation, are uncertain about ending fertility, have active or recent pelvic infection, delivered or had termination less than 6 weeks prior, have known contrast media allergy, or are pregnant/suspected pregnant.

Post-placement confirmationLabeling requires HSG approximately 3 months after placement to confirm device position and tubal occlusion; concomitant endometrial ablation on the same day is discouraged because it may prevent successful confirmation.

OpenPayer

Tubal Sterilization

Coverage Criteria

Coding

Provider Actions & Operational Notes

Background

Definitions