CurrentAetnaPolicy N/A

Male Infertility Injectable Medication Precertification Request

Form and requirements governing precertification requests for injectable medications used to treat male infertility for Aetna members; affects prescribing providers requesting authorization for these medications. Authorizations are valid for 6 months.

Policy Summary

PayerAetna

PolicyMale Infertility Injectable Medication Precertification Request

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a completed precertification form with required clinical documentation and lab work to obtain prior authorization valid for 6 months.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsauthorization validity

2 pagesform length

Lab work requiredsupporting documentation

Phone/Faxprecertification contact

Coverage Criteria for Injectable Male Infertility Medications

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Medical necessity elements (form-driven)

Covered when ALL of the following documented elements are provided:

Essential documentation: Completed precertification form with required clinical information and submitted lab work (sperm analysis, testosterone, FSH)

Form requests dates and values for labs and sperm analysis

Indication-specific criteria for hCG: Documented diagnosis of hypogonadotropic hypogonadism secondary to pituitary deficiency AND patient is undergoing infertility treatment or actively trying to conceive

Checkboxes on form capture this; applies to hCG (Novarel, Pregnyl)

Indication-specific criteria for menopausal gonadotropins and recombinant follitropins: Clinical evidence of primary or secondary hypogonadotropic hypogonadism documented; documentation whether patient has primary testicular failure must be provided and may affect coverage

Form asks whether medication will be used with hCG for induction of spermatogenesis

Gonal-F/Follistim prior therapy: For Follistim AQ, documented failure of Gonal-F or Gonal-FRFF (with dates of trial/failure) OR documented contraindication/intolerance/allergy to Gonal-F or Gonal-FRFF

Form specifically requests dates of prior trials and failure or notes of contraindication/intolerance

The precertification form explicitly asks whether the patient has primary testicular failure and whether prior sterilization procedures have occurred; these items are captured as required clinical queries that inform coverage decisions. Responses indicating primary testicular failure or prior sterilization serve as alternative or potentially exclusionary clinical findings that may affect approval for certain gonadotropin therapies.

The form does not include a discrete "not medically necessary" statement; instead it requires completion of specified clinical fields to support approval. Failure to provide the requested documentation — including the completed checkboxes for diagnosis, prior product trials, and the lab work referenced elsewhere on the form — may jeopardize authorization even though the form itself does not label any scenario explicitly as "not medically necessary."

Coding and Product Selections

ICD codes (placeholders)ICD-10

ICD	Primary ICD Code; Secondary ICD Code; Other ICD Code (placeholders captured on form)

Administration CPT codes (placeholder)CPT

CPT	Administration code(s) (CPT): (placeholders)

Medication products (form selections)mixed

NDC/HCPCS

Medication product selections listed (hCG 10,000 unit vial; Novarel or Pregnyl 10,000 unit vial; Menopur or Repronex 75 IU vial; Lupron; Zoladex; LHRH; Gonal-F (450 IU vial, 1050 IU vial); Gonal-F RFF (75 IU vial, 300 IU pen/redi-ject, 450 IU pen/redi-ject, 900 IU pen/redi-ject); Follistim AQ (75 IU vial, 150 IU cartridge, 300 IU cartridge, 600 IU cartridge, 900 IU cartridge) )

Precertification and Provider Requirements

Prior Authorization

Prior Authorization Required

Precertification (prior authorization) is required for injectable male infertility medications. All fields on the precertification request form must be completed and legible. Authorizations are valid for 6 months from the approval date.

All fields on the precertification request must be completed for review
Authorizations are valid for 6 months

Documentation Required

Required Clinical Documentation

Required clinical information must be completed in its entirety for all precertification requests. Lab work must be submitted with the request (most recent sperm analysis, testosterone, and FSH with dates).

Submit most recent sperm analysis (count, volume, clarity, motility) with date
Submit testosterone level with date
Submit FSH level with date
Provide answers to all clinical questions on the request form

Note

Prior Product Trial Information Requested

For Follistim AQ requests, indicate whether the patient has a documented failure of Gonal‑F or Gonal‑FRFF and provide dates of the trial and failure. If applicable, document any contraindication, intolerance, or allergy to Gonal‑F or Gonal‑FRFF.

If prior product trial = failure, include trial and failure dates
If prior product not tolerated, indicate contraindication/intolerance/allergy

Denial Risk

Fraud / Incomplete Information

Any person who knowingly submits false information or conceals material information to obtain authorization may be committing insurance fraud and is subject to criminal and civil penalties. The plan may request additional information or clarification to evaluate requests.

Providing materially false information or concealing material information may be considered fraud
Fraud may result in criminal and civil penalties
Plan may request additional information to evaluate requests

Background

The form collects clinical evidence to support use of gonadotropins, GnRH/LHRH analogs, and recombinant follitropins for male infertility. It requests documentation of diagnoses such as hypogonadotropic hypogonadism (including whether it is secondary to pituitary deficiency), whether the patient is actively attempting conception, and whether medications will be used in combination with hCG for induction of spermatogenesis. For recombinant products (for example, Follistim AQ), the form also requests prior product trial information — specifically whether there is a documented failure of Gonal‑F/Gonal‑FRFF and the dates of those trials — and asks about contraindications or intolerance to those products. Laboratory data (e.g., sperm analysis, testosterone, FSH) are required elsewhere on the form to complete the clinical picture for precertification review.

Definitions

Hypogonadotropic hypogonadism — definition and form queries

DefinitionHypogonadotropic hypogonadism: diagnosis queried as indication for hCG, menopausal gonadotropins, GnRH/LHRH, and recombinant follitropin products when secondary to pituitary deficiency and associated with infertility or active attempts to conceive.

Clinical evidence requestedForm asks whether there is clinical evidence of primary or secondary hypogonadotropic hypogonadism for menopausal gonadotropins and recombinant follitropins.

Associated treatment contextForm specifically asks if the patient is undergoing infertility treatment or actively trying to conceive when requesting hCG.

Combination useForm asks whether the medication will be used with hCG for induction of spermatogenesis (relevant for menopausal gonadotropins and follitropins).

Primary testicular failure — form queries and implications

DefinitionPrimary testicular failure: condition queried on the form as an alternative or exclusionary diagnosis when considering menopausal gonadotropins and recombinant follitropin products.

Form questionThe form includes explicit yes/no checkboxes asking whether the patient has primary testicular failure for menopausal gonadotropins and for urofollitropins/recombinant follitropins.

Impact on therapyPresence of primary testicular failure is queried alongside whether the medication will be used with hCG for induction of spermatogenesis, indicating it may affect coverage or treatment choice.

Applicability to agentsPrimary testicular failure is assessed for Menopur/Repronex and for follitropin products (Gonal-F, Gonal-FRFF, Follistim AQ).