Tubal Sterilization
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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.
No material clinical or coverage changes in this revision.
Coverage Criteria
Medically Necessary Procedures
Aetna considers the following procedures medically necessary for tubal ligation sterilization:
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:
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
| 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] |
| 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 |
| Z30.2 | Encounter for sterilization |
| A4264 | Permanent implantable contraceptive intratubal occlusion device(s) and delivery system [Essure microinsert] |
| 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 |
Provider Actions & Operational Notes
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.
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.
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.
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.
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.
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.
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.
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.
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.
Background
Hysteroscopic micro‑insert systems provide a non‑incisional, transcervical method of permanent contraception by placing an insert into each proximal fallopian tube to elicit tissue in‑growth and achieve tubal occlusion. Labeling and policy guidance require post‑placement imaging to verify occlusion; specifically, a hysterosalpingogram or equivalent imaging is recommended at about 3 months after placement to confirm device position and tubal occlusion. Early trials reported high placement success and efficacy, but safety concerns, manufacturer discontinuation of some products, and ongoing confirmatory testing requirements have affected availability and coverage stance.
Definitions
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