CurrentEmblemHealthPolicy M20190006

Medical Policy Criteria: Infertility (Commercial)

Defines medical necessity criteria, limitations, exclusions, and applicable procedure/CPT/HCPCS codes for infertility evaluation and treatment (IUI, IVF/ART, donor services, fertility preservation) for EmblemHealth/ConnectiCare commercial plans with referenced state mandates (CT, MA).

Policy Summary

PayerEmblemHealth (ConnectiCare)

PolicyMedical Policy Criteria: Infertility (Commercial)

Policy CodePolicy M20190006

Change TypeClarifications and substantive coverage updates (2023-2024)

Effective Date

Next Review Date

Key ActionTreating physicians must submit clinical documentation that the patient meets policy criteria (diagnostic imaging, semen analysis, ovarian reserve markers, prior cycle results) to enable prior authorization review.

SourceLink

POLICY UPDATE CHANGES

9/13/2024: Multiple edits across Limitations/Exclusions, poor prognosis language, ART section, and donor sperm cycle cost/storage limitation.

8/9/2024: Multiple substantive coverage clarifications and investigational listings.

3/27/2024: Operational restructuring of sections without new exclusion list beyond clarifications.

12/8/2023: Clarifications affecting operational approval of FET and storage billing.

05/12/2023: Clinical/operational parameter clarifications.

02/10/2023: Added explicit noncovered services and refined general indications.

12/11/2020 - 09/01/2020: Series of substantive additions and exclusions over 2020 timeframe.

04/01/2019: Initial policy establishment and code set additions.

3State-specific limits referenced (CT, MA, MA mandate details)

2-4IUI cycle limits (CT: 3; ovulation induction limited to 4 cycles)

2IVF cycle limits cited (CT: limited to two cycles)

>=3ART prerequisite IUI attempts before IVF (unless indicated)

MultipleRevision entries (2019-2024)

Coverage Summary

Overview: This ConnectiCare/EmblemHealth policy (Policy Number M20190006) defines medical necessity criteria for evaluation and treatment of infertility for commercial plans. It uses ASRM/ACOG practice guidance and peer-reviewed evidence to set diagnostic thresholds and treatment prerequisites, incorporates Connecticut and Massachusetts statutory mandates for coverage and facility standards, and distinguishes fertility preservation for iatrogenic infertility as a separate benefit. Coverage stance is mixed: services are covered when the policy's specific clinical criteria and thresholds are met; otherwise they are limited or excluded.

Key thresholds

Definition of InfertilityFailure to establish clinical pregnancy after 12 months of regular unprotected intercourse or donor insemination; or 6 months if female >= 35 years

FSH threshold>= 15 mIU/mL

AMH threshold< 0.3 ng/mL

AFC threshold< 7 antral follicles

IUI ovarian response example>= 1 follicle >= 15 mm (example); adequate response may also be defined as >=2 follicles >12 mm

Severe male factor (ICSI) thresholdsConcentration <= 5 million/mL (unwashed), motility <= 25%, normal morphology <= 4%; requires two abnormal semen analyses within past year with >=1 abnormal within 3 months

Conversion (IUI-to-IVF) estradiol thresholdEstradiol >= 800 pg/mL

dates.last_review2024-08-09

policy_numberM20190006

Medical Necessity Criteria

General Indications for Initial and Continuation of Infertility Treatment Coverage

Covered when ALL of the following are met:

ALL of the following

Prognosis for conception must be >= 2.5%
No evidence of significant diminished ovarian reserve (except donor egg for premature ovarian failure)
- one or more of the following markers within prior 6 months: FSH level >= 15 mIU/mL
  marker of diminished ovarian reserve
- one or more of the following markers within prior 6 months: AMH level < 0.3 ng/mL
  marker of diminished ovarian reserve

Coding

Applicable Procedure/CPT/HCPCS Codes (listed)mixed

58321	Artificial insemination; intra-cervical
58322	Artificial insemination; intra-uterine
58323	Sperm washing for artificial insemination
58340	Catheterization and introduction of saline or contrast material for saline infusion sonohysterography (SIS) or hysterosalpingography
58345	Transcervical introduction of fallopian tube catheter for diagnosis and/or re-establishing patency
58752	Tubouterine implantation
58760	Fimbrioplasty
58970	Follicle puncture for oocyte retrieval, any method
58974	Embryo transfer, intrauterine
76831	Saline infusion sonohysterography (SIS), including color flow Doppler

1–10 of 54

1/6

Excluded / Not Covered Procedures (policy exclusions list)mixedNot Covered

89250	Culture of oocyte(s)/embryo(s) less than 4 days - listed as not covered for FET cycles only (see exclusions)
HCPCS 54026	Example cited: cost of procurement and storage of donor sperm (not covered)

Noncovered HCPCS example (mentioned)HCPCSNot Covered

No codes listed

Provider Actions

Prior Authorization

Prior authorization required for infertility services

Prior authorization is required for most infertility services. Requests must be submitted and approved prior to initiating services to ensure medical necessity and member eligibility.

Affected service types: IUI (intrauterine insemination), IVF/ART (including IVF, GIFT, ZIFT), donor services (egg or sperm) and associated processing/transfer services
Cryopreservation and storage: prior authorization required except when performed solely for fertility preservation related to iatrogenic infertility (e.g., before cancer treatment) — fertility preservation cases follow separate authorization rules

Documentation Required

Submit clinical evidence for prior authorization

Submit clinical evidence with the prior authorization request to support medical necessity. Provide the documents listed below; incomplete submissions may result in delays or denial.

Background, Evidence & Definitions

Background and alignment: This policy reflects ConnectiCare/EmblemHealth application of ASRM/ACOG practice committee guidance and peer-reviewed evidence in defining infertility, ovarian reserve thresholds (e.g., FSH, AMH, AFC), IUI/IVF prerequisites, and ART standards. It incorporates Connecticut and Massachusetts statutory mandates requiring coverage limits, facility conformity to ASRM standards, and specified cycle limits. The policy also notes fertility preservation for iatrogenic infertility (e.g., gonadotoxic treatment or gender‑affirming care) is a separate benefit and does not count toward IVF cycle limits.

Source	Notes
ASRM guidance (practice committee opinions)	Referenced throughout policy for definitions, ovarian reserve testing, single embryo transfer, futility guidance; specific ASRM reports cited in References section
Peer-reviewed studies (selected)	Policy cites JAMA 2015 on live-birth rates with repeat IVF; Fertility & Sterility and Human Reprod studies on fresh vs frozen transfers and embryo transfer outcomes
Selected references / systematic reviews / registries	Cochrane 2006, systematic reviews on maternal age (2017,2020), registry analyses and multiple Fertil Steril/Hum Reprod references listed in References

Definitions

Infertility: Disease characterized by failure to establish clinical pregnancy after 12 months of regular unprotected intercourse or donor insemination, or after 6 months if female >= 35 years; special note for single females without male partner requiring failure of 6 medically managed IUI cycles using donor sperm (costs of donor sperm/storage and IUIs to demonstrate infertility not covered)

IUI: Intrauterine insemination: catheter deposits sperm sample into uterus.

Revision History

9/13/2024clarifiedLatest

Clarified that MA members are covered for storage of gametes/embryos when treatments indirectly cause impairment of fertility; replaced wording about ARTs and poor prognosis to specify '2 or more medicated' ARTs; clarified IUI prerequisite for women without male partners (failure of 6 medically managed IUIs); corrected 'fresh' to 'frozen' regarding semen analysis in ART section; added noncovered HCPCS example for cost of procurement and storage of donor sperm.

8/9/2024added

Added clarification that MA members are covered for storage of gametes/embryos when fertility is indirectly impaired; removed age parameters for FSH levels and IVF cycles; updated male factor infertility definitions and morphology thresholds; reinstated poor prognosis language; required two abnormal semen analyses within past year with at least one within 3 months for severe male factor; added high risk of morbidity to PGT prerequisites; added donor sperm items for biological males with genetic sperm defects and for females without male partners; stated fresh IVF cycles require normal intrauterine cavity; listed Sperm-Hyaluronan Binding Assay and Embryo Glue as investigational.

Policy Summary

PayerEmblemHealth (ConnectiCare)

PolicyMedical Policy Criteria: Infertility (Commercial)

Policy CodePolicy M20190006

Change TypeClarifications and substantive coverage updates (2023-2024)

Effective Date

Next Review Date

SourceLink

On This Page

one or more of the following markers within prior 6 months: Antral follicle count (AFC) < 7 (ASRM)

marker of diminished ovarian reserve

If prior monitored med-stimulated infertility treatment within 6 months, it must demonstrate adequate ovarian response to stimulation

Examples: at least 1 follicle >= 15 mm diameter for IUI; Minimum of 1 follicle >= 15 mm diameter for ART

Ovarian failure where couple is attempting conception with their own gametes

Two or more medicated ART cycles without adequate egg production, fertilization and/or embryo development

Artificial Insemination (IUI) Criteria

Member must meet general infertility definitions/prognosis AND ALL of the following:

ALL of the following

Diagnostic imaging
- Tubal patency of at least one tube
- Normal endometrial cavity
Semen analysis
- Normal semen analysis
- Male factor infertility (excludes severe male factor infertility)
Indications
- Unexplained infertility
- PCOS, anovulation, or oligoovulation
- Minimal or mild endometriosis
- Cervical factors (e.g., trauma, conization, anatomical irregularities)
- Male factor infertility (excluding severe)
- Vaginismus diagnosis
- Use of stored sperm from male members who banked due to gonadotoxic medical treatment
Prior IUI response: If prior IUI cycles exist, submitted results must demonstrate adequate ovarian response to stimulation (e.g., at least 2 follicles >12 mm or 1 follicle >=15 mm)

Assisted Reproductive Technology (ART/IVF) Criteria

All of the following must be met for IVF/ART coverage:

ALL of the following

History of at least three failed IUI cycles unless medically indicated to go straight to IVF
All transferrable and/or viable oocytes/embryos have been utilized prior to this request (note: first embryo transfer within 120 days of a freeze-all cycle considered continuation of prior cycle)
Diagnostic imaging report within 2 years showing a normal endometrial cavity
Semen analysis (one sample within one year) (not required for FET cycles)
Indications
- Unexplained infertility
- Premature ovarian failure
- Ovulatory dysfunction (e.g., ovulation induction not resulted in conception, poor response, hyper-response)
- History of severe endometriosis and/or failed medical/surgical therapies
- Female with bilateral fallopian tube absence or obstruction due to prior tubal disease with failed conventional therapy
- Severe male factor infertility
- Women without male partners or exposure to sperm (single female/same-sex couple)
- Conversion of fresh to freeze-all cycle when progesterone concentration (P4) > 1 ng/mL at time of hCG trigger injection

IVF Cycle Protocol and Embryo Transfer Rules

IVF Cycle Protocol

1st IVF treatment cycle: Single embryo transfer (SET) is required
Thaw/quality exception: If no top-quality embryos after thawing, two or more embryos of any quality may be transferred
2nd and subsequent cycles: SET/FET required if member has one or more embryos frozen; if no top-quality embryos after thawing, then two embryos of any quality may be transferred
Fresh cycle rule: Fresh IVF cycle with SET if no frozen embryos available

Cryopreservation and Fertility Preservation

ANY of the following

Cryopreservation of embryos authorized in conjunction with an approved infertility cycle for embryos remaining after an IVF cycle; cryopreserved embryos must be used before fresh IVF cycles using member's or donor's eggs are authorized
Fertility preservation separate benefit: Fertility preservation services are a separate benefit and do not count toward the three-cycle limit on IVF; no infertility workup required
Covered for egg (oocyte) retrievals and sperm collection only; Covered when medical treatment will directly or indirectly result in iatrogenic infertility (e.g., gonadotoxic cancer treatments), members planning gender-affirming treatment, or other medically necessary treatments expected to render member permanently infertile (excluding voluntary sterilization)

Assisted Hatching

Assisted hatching considered medically necessary as part of any IVF procedure when documentation confirms ANY of the following:

ANY of the following

Advanced maternal age >= 38 years
Prior pregnancy resulting from IVF where assisted hatching was performed
Prior failed IVF cycles that produced 3 or more euploid embryos with failure to implant after embryo transfer
Thickened zona pellucida on microscopy

ICSI and Male Factor Procedures

ICSI covered when member meets general infertility definitions/prognosis AND ANY of the following:

ANY of the following

Severe male factor (two abnormal analyses in past year; one within 3 months)
- Sperm concentration <= 5 million/mL (unwashed specimen)
- Motility <= 25%
- Normal morphology <= 4%
Other ICSI indications
- Reduced fertilization on a prior IVF cycle using non-donor sperm with fertilization rate <= 40% with standard insemination of mature eggs
- Obstruction of male reproductive tract unrelated to prior sterilization or reversal, not amenable to repair (necessitating sperm retrieval via MESA)
- Nonobstructive azoospermia (necessitating TESE)
- Member meets criteria for Preimplantation Genetic Testing (PGT)
- ICSI is performed when fertilizing previously frozen oocytes (with or without donor sperm)

Preimplantation Genetic Testing (PGT)

PGT medically necessary as part of IVF when ANY of the following are documented:

ANY of the following

Both partners are known carriers of a single autosomal recessive disorder with high risk of comorbidity
One partner has a balanced translocation
One partner has a single-gene autosomal dominant disorder
One partner is a known carrier of an X-linked disorder
Testing to determine sex of embryo when documented history of X-linked disorder and management decisions hinge on sex

Donor Services

Donor egg or sperm services covered when general requirements met AND documentation confirms ANY of the following:

ANY of the following

Donor egg covered for women with:
- Congenital or surgical absence of ovaries
- Clinically documented premature ovarian insufficiency/failure (e.g., women 40 years with elevated FSH in menopausal range and amenorrhea per ACOG)
- Inadequate ovarian response (fewer than 3 follicles >12 mm) or inadequate embryo numbers/quality during authorized IVF cycles within prior 6 months
- Genetic abnormality
Donor sperm (normal quality) medically necessary when:
- Bilateral congenital absence of vas deferens (BCAVD)
- Non-obstructive azoospermia confirmed through MESA/TESE results
- Previous radiation or chemotherapy resulting in abnormal semen analyses
- Two or more abnormal semen analyses at least 30 days apart in last 3 months
- High risk of transmitting male partner's genetic disorder to offspring
- HIV+ male partner
- For biological females without a biological male partner (subject to donor sperm criteria elsewhere)

Diagnostic imaging demonstrating uterine cavity and tubal status (e.g., HSG, sonohysterosalpingogram, sonohysteroscopy, 3D ultrasound, or HyCoSy) performed within the prior 2 years
Semen analysis report (see timing rules below) and interpretation
Ovarian reserve markers (FSH, AMH, and/or antral follicle count) with dates — markers must be within 6 months of request
Prior cycle documentation when applicable (monitored medicated IUI or ART cycles within prior 6 months showing ovarian response; prior ART cycle results including oocyte yield, fertilization, and embryo development)
Donor documentation when donor gametes are used (medical screening and donor eligibility per applicable guidelines)

Billing Rule

IVF cycle definitions and counting toward limits

IVF cycles are defined operationally and state mandates may limit the number of covered cycles. Ensure billing and requests reflect the definition and applicable state limits; fertility preservation does not count toward IVF limits.

IVF cycle definition: a cycle starts with ovulation induction/stimulation and is considered complete at oocyte retrieval
Connecticut limits: IVF (including GIFT, ZIFT and similar procedures) limited to two cycles (each fertilization/transfer credited as one cycle; maximum two embryo implantations per cycle)
Massachusetts: coverage subject to state mandate conditions (IVF only after failure of less expensive covered options and facility standards per ASRM/ACOG)
Fertility preservation (cryopreservation for iatrogenic infertility) is excluded from counting toward state IVF cycle limits

Documentation Required

Ovarian reserve and semen analysis timing

Specify the recency requirements for ovarian reserve testing and semen analysis when submitting authorization requests. Also document criteria for severe male factor requiring repeat testing.

Ovarian reserve markers: FSH, AMH and/or antral follicle count (AFC) must be performed within the prior 6 months for initial or continuation ART authorization
Semen analysis: at least one semen analysis performed within the prior 1 year must be submitted with the request
Severe male factor: when severe male factor is suspected (e.g., concentration <5 million/mL unwashed, motility <25%, morphology thresholds), two abnormal semen analyses are required to document isolated teratospermia or severe male factor — repeat analyses should be 1–4 weeks apart per ASRM guidance

Prior Authorization

Frozen embryo transfer continuation condition

Continuation of frozen embryo transfer (FET) cycles may be conditional on prior genetic testing or program rules; observe transfer timing rules for first embryo transfers and PGT-related pathways.

FET continuation: authorization for subsequent FETs may be conditional on prior preimplantation genetic testing (PGT) results if clinically indicated
Timing rules for first embryo transfer: follow program definitions for allowable windows (e.g., embryo transfer scheduling conventions such as 60/120 days from thaw or other program-defined intervals) — confirm specific timing requirements at authorization
Document prior embryo transfer attempts and outcomes when requesting additional FETs

Denial Risk

Denial risk for substance use or active sterilization

Services may be denied when contraindications exist; verify behavioral and surgical history before submitting requests.

Denial risk if member has ongoing substance use that would place a resulting pregnancy at unacceptable risk
Denial risk for unreversed voluntary sterilization (e.g., intact vasectomy or tubal ligation without documented reversal or records confirming restoration of fertility) unless reversal documented and clinically appropriate

Provide complete supporting records at time of request to facilitate timely review and authorization decisions.

IVF: In vitro fertilization: extraction of eggs, fertilization in lab, embryo transfer to uterus.

Iatrogenic infertility: Impairment of fertility due to surgery, radiation, chemotherapy or other medical treatments affecting reproductive organs/processes.

Severe male factor infertility: Severe male factor defined by sperm concentration <= 5 million/mL (unwashed), motility <= 25%, and normal morphology <= 4%; policy requires two abnormal semen analyses within past year with at least one within 3 months for ICSI/donor decisions

Freeze-All/FET continuation: The first embryo transfer within 120 days of a freeze-all cycle is considered continuation of the freeze-all cycle; approval for FET continuation may be conditional on PGT

3/27/2024revised

Operational restructuring: consolidated ART cycle type wording and moved limitations/exclusions; moved Male Infertility Factor to definitions; clarified ICSI and cryopreservation wording; clarified donor services and fertility preservation language.

12/8/2023added

Clarified Freeze-All cycles and that approval for FET continuation may be conditional on PGT; noted current semen analysis not required when FET is requested; added 'storage' to noncovered expenses in donor services and IVF for women without male partners.

05/12/2023added

Clarified IVF operational parameters: added HSG/sonohysterosalpingogram/hysteroscopic documentation of normal cavity within past 2 years to IVF section; clarified progesterone concentration numeric edits and other IVF/ICSI clarifications.

02/10/2023added

Added explicit noncoverage of uterine transplant for uterine factor infertility; modified general indications to exclude significant diminished ovarian reserve except donor eggs for premature ovarian failure; added cryopreservation noncoverage for purposes other than gonadotoxic treatments or reciprocal IVF.

12/11/2020 - 09/01/2020added

Series of substantive changes in 2020: updated infertility definition; added general indications; added sonohysterosalpingogram as tubal occlusion screening option; clarified ICSI indications and added noncovered sperm DNA integrity tests and laboratory tests for cycle monitoring when cycle not approved.

04/01/2019added

New policy created (initial establishment of coverage criteria and code set; additional codes added historically).

Women without male partners or exposure to sperm only if documentation confirms failure of 6 consecutive medically managed IUI cycles using donor sperm