Male Infertility Injectable Medication Precertification Request
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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.
No material clinical or coverage changes in this revision.
Coverage Criteria for Injectable Male Infertility Medications
Medical necessity elements (form-driven)
Covered when ALL of the following documented elements are provided:
Form requests dates and values for labs and sperm analysis
Checkboxes on form capture this; applies to hCG (Novarel, Pregnyl)
Form asks whether medication will be used with hCG for induction of spermatogenesis
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 | Primary ICD Code; Secondary ICD Code; Other ICD Code (placeholders captured on form) |
| CPT | Administration code(s) (CPT): (placeholders) |
| 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 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
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
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
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
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