Health Net Infertility Coverage Update

Coverage Criteria and Clinical Necessity

Initial Approval Criteria

Medications are medically necessary when ALL specified criteria in the relevant category are met.

General requirement: Member must have infertility/fertility preservation coverage and the medication must be prescribed by or in consultation with a reproductive endocrinologist (or appropriate specialist for males/children). Provider must submit supporting documentation.

See policy documentation requirements

A. Infertility, Female: Member has diagnosis of infertility; age >= 18 years; prescribed by or in consultation with a reproductive endocrinologist; requested drug is for ovulation induction (OI) or assisted reproductive technology (ART) as defined; member does not have primary ovarian insufficiency (POI); for unexplained infertility, failure of at least 3 cycles of clomiphene citrate or letrozole combined with intrauterine insemination unless contraindicated; if ovulatory disorder is secondary to hyperprolactinemia, failure of dopamine agonist treatment unless contraindicated; if request is for brand Cetrotide, member must have used generic cetrorelix unless contraindicated or has clinically significant adverse effects.Approval duration: 30 days

See Initial Approval Criteria section

B. Fertility Preservation, Female: Request is for embryo or oocyte cryopreservation secondary to planned gonadotoxic therapy or gonadectomy; member has documented fertility preservation counseling and executed informed consent (or parental/guardian consent for peri/postpubertal minors as applicable); prescribed by or in consultation with a reproductive endocrinologist; member does not have POI.

See Fertility Preservation criteria

C. Infertility, Male: Request is for Gonal-f, Follistim-AQ, or Pregnyl; member has infertility due to hypogonadotropic hypogonadism (HH); age >= 18 years; prescribed by or in consultation with a reproductive endocrinologist or urologist; products are requested as either (a) Gonal-f or Follistim-AQ in combination with Pregnyl to induce spermatogenesis once serum testosterone is within the normal range, or (b) Pregnyl as single-agent therapy to increase testosterone to the target range; testosterone therapy is not prescribed concomitantly; member does not have primary testicular failure.Approval duration: 6 months

Testosterone target for spermatogenesis induction: 400 to 800 ng/dL

D. Prepubertal Cryptorchidism: Request is for Pregnyl for diagnosis of prepubertal cryptorchidism; prescribed by or in consultation with a pediatric specialist (endocrinology, urology, genetics, or surgery); age < 9 years and either not a candidate for corrective surgery or therapy is coordinated with surgical care as appropriate.Approval duration: 3 months

See Prepubertal Cryptorchidism criteria

Continued Therapy

Covered when ALL of the following are met for continued therapy:

Continued therapy general: Member must have infertility/fertility preservation coverage; request is for ongoing OI, ART cycle, male infertility therapy, or prepubertal cryptorchidism therapy; member is currently receiving medication via the Centene benefit or has previously met initial approval criteria (continuity of care applies when state/product regulations require); member is responding positively to therapy; documentation of ongoing response and that pregnancy has not yet been achieved for the current reproductive attempt when applicable must be provided.Approval durations vary by indication (e.g., 30 days generally; 3 months for prepubertal cryptorchidism)

See Continued Therapy section for required continuity documentation

Infertility, Male

Covered when ALL of the following are met for male infertility due to HH:

Male infertility (HH): Member must have infertility/fertility preservation coverage; request is for Gonal-f, Follistim-AQ, or Pregnyl; diagnosis of infertility due to hypogonadotropic hypogonadism; age >= 18 years; prescribed by or in consultation with a reproductive endocrinologist or urologist; member is currently receiving medication or has previously met initial approval criteria; member is responding positively to therapy and the current reproductive attempt has not yet achieved pregnancy; testosterone therapy is not being given concomitantly.Approval duration: 6 months (initial)

Agent regimens may extend up to 12–24 months or longer per dosing guidance

Prepubertal Cryptorchidism

Covered when ALL of the following are met for Pregnyl use in prepubertal cryptorchidism:

Prepubertal cryptorchidism: Request is for Pregnyl for diagnosis of prepubertal cryptorchidism; member is currently receiving medication via the Centene benefit or has previously met initial approval criteria (continuity of care applies where relevant); member is responding positively to therapy; member has not received more than 3 months of therapy; corrective surgery (orchidopexy) is considered first‑line prior to gonadotropin therapy.Maximum duration: 3 months

Approval duration explicitly 3 months; surgery is first-line per general information

Notable coverage edits and limits (partial)

Selected coverage policy actions and limits noted in document excerpts:

HIM evidence-of-coverage expansion: Evidence of coverage for infertility/fertility preservation language was added for the HIM line of business covering multiple states; state list was updated across reviews.

See 4Q2023 and 4Q2024 updates

Prepubertal cryptorchidism continued therapy limit: Member has not received more than 3 months of therapy for prepubertal cryptorchidism to qualify for continued therapy coverage.<= 3 months prior therapy

Added in 4Q2023 review

Step therapy for OI and ART: Step therapies were added for ovulation induction and assisted reproductive technology; requests must meet step therapy requirements and brand-to-generic redirection for Cetrotide to generic cetrorelix applies unless contraindicated.

Step therapies added 4Q2020; Cetrotide brand-to-generic requirement added

This policy differentiates between services for fertility preservation (covered when medically necessary for planned gonadotoxic therapy or procedures) and treatments intended to achieve pregnancy outside of fertility preservation. Per state-specific provisions, services and supplies that are solely intended to impregnate a woman — for example procedures that involve harvesting, manipulating, or transferring gametes or embryos, and supplies used to prepare a person for those procedures — may be excluded depending on the state and contract. Providers must confirm member-specific benefits and prior authorization requirements before initiating treatment.

The policy explicitly excludes certain uses from authorization. Treatment of obesity is listed as a diagnosis/indication for which coverage is not authorized. In addition, non‑FDA approved indications that are not addressed in this policy will not be authorized unless the provider submits sufficient documentation of efficacy and safety consistent with the applicable off‑label use policies (see referenced off‑label policy numbers). Requests for excluded indications may be denied during prior authorization review.

Use of policy drugs when the requested indication is treatment of obesity is explicitly excluded from coverage. Requests for these agents for obesity will be denied and are not considered under the infertility/fertility preservation criteria in this policy.

State-specific provisions modify scope of coverage: for example, California (CA) covers medically necessary fertility preservation services and supplies for iatrogenic infertility but, except for fertility preservation, services intended to impregnate a woman (such as IVF, artificial insemination, GIFT, ZIFT and associated supplies) are not covered under certain contracts. Other states differ in limits for diagnostic services, numbers of cycles covered, or prerequisites for coverage — verify the member's state and contract for precise coverage rules.

Off‑label or non‑FDA indications that are not addressed in this policy require documentation consistent with the applicable off‑label use policies (for example CP.PMN.53 and related off‑label policies). Unless such documentation demonstrates sufficient evidence of safety and efficacy per the off‑label policy, requests for non‑FDA indications are considered not authorized.

Inclusion of a billing code or drug in the policy's coding lists does not, by itself, guarantee coverage. The policy notes that codes are provided for informational purposes and providers should reference current professional coding guidance and confirm member benefits and authorization requirements before submitting claims.

Drugs, Codes, and Dosing Examples

Named drug productsmixed

Menopur	Menotropin (hMG)
Gonal-f	Follitropin alfa, recombinant (FSH) — includes Gonal-f RFF formulations
Follistim-AQ	Follitropin beta, recombinant (FSH)
Ganirelix acetate	GnRH antagonist
Cetrotide / cetrorelix	GnRH antagonist (brand and generic)
Ovidrel	Choriogonadotropin alfa (hCG)
Pregnyl	Human chorionic gonadotropin (hCG)

Product availability (examples)mixed

Menopur	Injection: 75 U FSH and 75 IU per vial (product availability)
Gonal-F	Multi-dose vial: injection formulations (product availability)
Gonal-F RFF Redi-ject	Prefilled auto-injection device: 300 U/0.5 mL, 450 U
Follistim-AQ	Injection cartridge: 150 U, 300 U, 600 U, 900 U

HCPCS codes referencedHCPCS

S0122
S0126	Injection, follitropin alfa, 75 iu
S0128
S0132	Injection, ganirelix acetate, 250 mcg
J0725
J3490	Unclassified drug
J3590	Unclassified biologics
J0725

Referenced fertility drugs (informational)mixed

Gonal-f (follitropin alfa)	Dosing regimens and maximum doses noted in prescribing information
Follistim-AQ (follitropin beta)	Dosing regimens and maximum doses noted in prescribing information
Pregnyl (hCG)	Dosing regimens and maximum doses noted in prescribing information
Ganirelix acetate / Cetrotide / Ovidrel	Product availability and strengths listed

inv-16: Testosterone target for spermatogenesis induction

Testosterone target for spermatogenesis induction400 to 800 ng/dL

ContextPregnyl (hCG) may be used as single-agent therapy to increase testosterone into the normal range to induce spermatogenesis

Related therapy noteTestosterone therapy should not be prescribed concomitantly when using hCG for spermatogenesis induction

inv-17: Maximum daily dosing examples

Menopur — maximum daily exampleUp to 450 IU SC per day

Follistim-AQ — maximum daily example

Prior Authorization, Documentation, and Step Therapy Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for fertility medications covered under this policy. Providers must obtain prior authorization before dispensing or administering drugs listed in the policy (examples include Menopur, Gonal-f, Gonal-f RFF, Follistim-AQ, ganirelix acetate, Cetrotide/cetrorelix, Ovidrel, Pregnyl). Step therapy and sequencing edits apply to ovulation induction (OI) and assisted reproductive technology (ART) regimens; providers must follow the required therapy sequencing. Inclusion of a code in this document does not guarantee coverage — prior authorization approval is required to confirm medical necessity and benefits eligibility.

Affected HCPCS/administration codes referenced in policy: S0122, S0126, S0128, S0132, J0725, J3490, J3590.
Step therapy added to OI and ART during 4Q2020 review — follow sequencing for initial and subsequent therapy attempts.
Brand Cetrotide requests must be preceded by trial of generic cetrorelix unless contraindicated or adverse effects are documented.

Documentation Required

Clinical Background and Policy Scope

Gonadotropins (FSH-containing agents such as Gonal‑f, Follistim‑AQ, Menopur) and GnRH antagonists (e.g., ganirelix, cetrorelix/Cetrotide) are used across assisted reproductive technology (ART) and ovulation induction (OI) protocols to stimulate follicular development and control endogenous gonadotropin activity during controlled ovarian stimulation. Human chorionic gonadotropin preparations (hCG) such as Ovidrel and Pregnyl are used to induce final follicular maturation and as part of spermatogenesis induction regimens in men with hypogonadotropic hypogonadism. These agents also have specific uses in pediatric indications (for example, Pregnyl for prepubertal cryptorchidism) and in fertility preservation cycles when oocyte or embryo cryopreservation is planned prior to gonadotoxic therapy. Prescribing and authorization requirements in this policy reflect those clinical roles and require documentation that the medication is being used for an appropriate infertility or fertility preservation indication.

Key Definitions

inv-31: Iatrogenic infertility

DefinitionIatrogenic infertility is infertility caused by a medical intervention, including reactions from prescribed drugs or from medical or surgical procedures (e.g., cancer treatments such as surgery, radiation, chemotherapy) that may impair reproductive organs or processes.

Coverage context exampleFertility preservation services and supplies are covered when a cancer treatment may directly or indirectly cause iatrogenic infertility (AZ, CA examples).

Exclusions noteServices intended to impregnate a woman (e.g., IVF, artificial insemination) may be excluded outside of fertility preservation depending on state/contract.

inv-32: ART — assisted reproductive technology definition (IVF example)

DefinitionAssisted reproductive technology (ART): medical procedures such as in vitro fertilization (IVF) involving controlled ovarian stimulation and embryo transfer.

Policy Changes and Material Updates

2024-07-16amendmentLatest

HIM evidence-of-coverage states updated (added AR, IL, LA, NV; removed KS, MI, NE, NM, SC); HCPCS codes J3490 and J3590 added to coding list; brand Cetrotide requests redirected to generic cetrorelix; other minor removals (Novarel).

2023-06-29amendment

Evidence-of-coverage language for infertility/fertility preservation added to HIM line of business for multiple states (examples: AZ, CA, KS, MI, NE, NJ, NM, NC, SC); continued therapy criterion for prepubertal cryptorchidism limited to members not having received more than 3 months of therapy; Bravelle references removed due to discontinuation.

OpenPayer

Clinical Policy: Infertility and Fertility Preservation