CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Chorionic Gonadotropin (hCG) Therapies — Coverage Criteria

Defines coverage, prior authorization requirements, and clinical criteria for Novarel, Pregnyl, Ovidrel and other hCG products for indications including ovulation induction/ART, hypogonadotropic hypogonadism, and prepubertal cryptorchidism for members of the plan.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyChorionic Gonadotropin (hCG) Therapies — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with required clinical documentation (testosterone, FSH, LH) when requesting treatment for hypogonadotropic hypogonadism; prior authorization is required for covered indications.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3FDA‑approved indication groups listed

12 moAuth length (ovulation/ART, hypogonadotropic)

6 moAuth length (cryptorchidism)

3Lab tests required for PA

Coverage Criteria for Chorionic Gonadotropin (hCG)

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inv-01: Covered Indications

Covered when the requested use is an FDA‑approved indication or listed compendial use and all approval criteria are met.

Covered indications: Member's requested use must be one of the FDA‑approved indications or a listed compendial use. FDA‑approved indications include: (1) prepubertal cryptorchidism not due to anatomic obstruction (Novarel/Pregnyl); (2) selected cases of male hypogonadotropic hypogonadism (hypogonadism secondary to pituitary deficiency) (Novarel/Pregnyl); (3) induction of ovulation and pregnancy in anovulatory infertile women appropriately pretreated with human gonadotropins (Novarel/Pregnyl). Ovidrel FDA indications include induction of final follicular maturation and early luteinization in ART after pituitary desensitization and pretreatment with FSH, and induction of ovulation in functional anovulatory infertility. Compendial uses such as infertility and luteal phase support are also covered.

All coverage is subject to meeting the applicable approval criteria for the specific indication and to member eligibility; indications outside the FDA‑approved and compendial uses are considered experimental/investigational and not medically necessary.

inv-02: Hypogonadotropic Hypogonadism

Authorization criteria for hypogonadotropic hypogonadism

Hypogonadotropic hypogonadism authorization: Member must have documented low pretreatment testosterone levels AND low or low‑to‑normal follicle stimulating hormone (FSH) or luteinizing hormone (LH) levels. Submit testosterone, FSH, and LH laboratory results with the prior authorization request.

Authorization may be granted for up to 12 months when criteria are met.

inv-03: Ovulation induction / ART

Authorization for ovulation induction and assisted reproductive technology (ART).

Ovulation induction/ART authorization: Member undergoing ovulation induction or assisted reproductive technology (ART) must meet the clinical program requirements appropriate to the selected product (e.g., pituitary desensitization and pretreatment with FSH when using Ovidrel). When criteria are met, authorization may be granted for up to 12 months.

Patients receiving the drug as part of an approved medical procedure may bypass Specialty Guideline Management review if the medical authorization number and confirmation of the approved procedure are provided.

inv-04: Prepubertal Cryptorchidism

Authorization for prepubertal cryptorchidism

Prepubertal cryptorchidism authorization: Authorization may be granted for treatment of prepubertal cryptorchidism when the condition is not due to anatomic obstruction.

Authorization duration may be up to 6 months.

All indications not explicitly listed as FDA‑approved or as accepted compendial uses (e.g., infertility and luteal phase support) are considered experimental/investigational and therefore not medically necessary.

Uses outside of the FDA‑approved indications and the listed compendial uses are considered not medically necessary and will not be authorized.

Provider Actions and Prior Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for requests. Authorization durations: up to 12 months for induction of oocyte maturation and/or release (ovulation induction/ART) and for hypogonadotropic hypogonadism; up to 6 months for prepubertal cryptorchidism.

Authorization length: • Induction of oocyte maturation and/or release (ovulation induction/ART): up to 12 months. • Hypogonadotropic hypogonadism: up to 12 months. • Prepubertal cryptorchidism: up to 6 months.

Documentation Required

Medical Benefit Alignment — When SGM Review May Be Bypassed

If the drug is being requested as part of a procedure already approved under the member's medical benefit, the Specialty Guideline Management coverage review may be bypassed. When bypass applies, submit the medical authorization number and confirmation of the approved procedure(s). Note: some plans may opt out of medical benefit alignment; those members must meet the standard prior authorization requirements in Section IV.

When bypassing SGM, include the medical authorization number and documentation of the approved medical procedure.
Some plans may opt out of medical benefit alignment — if so, follow standard PA requirements.

Documentation Required

Required Laboratory Documentation

For prior authorization requests for hypogonadotropic hypogonadism, submit laboratory documentation of pretreatment testosterone, follicle stimulating hormone (FSH), and luteinizing hormone (LH) results.

Required labs to include with PA: testosterone, FSH, LH.

OpenPayer

Chorionic Gonadotropin (hCG) Therapies — Coverage Criteria

Coverage Criteria for Chorionic Gonadotropin (hCG)

Provider Actions and Prior Authorization Requirements

Background

Definitions