CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Chorionic gonadotropin (hCG) products — coverage criteria

Defines coverage criteria, documentation, and authorization periods for Novarel, Pregnyl, Ovidrel (hCG products) for infertility-related uses, prepubertal cryptorchidism, and hypogonadotropic hypogonadism for members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyChorionic gonadotropin (hCG) products — coverage criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit pretreatment testosterone, FSH, and LH laboratory levels to initiate prior authorization for hypogonadotropic hypogonadism.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3FDA‑approved indication groups listed

12 monthsAuth period (ovulation induction/ART & hypogonadotropic hypogonadism)

6 monthsAuth period (prepubertal cryptorchidism)

3Required lab tests for hypogonadotropic hypogonadism

All othersNon‑covered/experimental indications

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Coverage Criteria

Covered indications

Covered when ALL of the following are met for the specified indication group

FDA‑approved indications - Novarel/Pregnyl: Any of: prepubertal cryptorchidism not due to anatomic obstruction; selected cases of hypogonadotropic hypogonadism (hypogonadism secondary to pituitary deficiency) in males; induction of ovulation and pregnancy in anovulatory infertile women whose anovulation is secondary (not due to primary ovarian failure) and who have been appropriately pretreated with human menotropins.

From Novarel/Pregnyl FDA indications

FDA‑approved indications - Ovidrel: Any of: induction of final follicular maturation and early luteinization in infertile women after pituitary desensitization and appropriate pretreatment with follicle‑stimulating hormones as part of an ART program (e.g., IVF/embryo transfer); induction of ovulation and pregnancy in anovulatory infertile patients when the cause of infertility is functional and not due to primary ovarian failure.

From Ovidrel FDA indications

Compendial use: Use for infertility and luteal phase support is considered a covered compendial use when approval criteria are met.

Compendial use specified

Authorization durations and lab criteria

Authorization duration granted when treatment meets indication criteria

Authorization durations: Ovulation induction or assisted reproductive technology (ART): authorization up to 12 months; Prepubertal cryptorchidism: authorization up to 6 months; Hypogonadotropic hypogonadism: authorization up to 12 months when documented low pretreatment testosterone and low or low‑to‑normal FSH or LH levels are provided.

See sections III.A–C; required labs for hypogonadotropic hypogonadism include pretreatment testosterone, FSH, and LH

Continuation of therapy

Continuation criteria: All members (including new members) requesting authorization for continuation of therapy must meet all initial authorization criteria.

Section V

All indications for chorionic gonadotropin (hCG) products that are not specifically listed as FDA‑approved indications or the specified compendial uses (infertility, luteal phase support) are considered experimental/investigational and not medically necessary.

Requests for hCG use outside of the listed FDA‑approved indications and the specified compendial uses (infertility, luteal phase support) will be considered not medically necessary (experimental/investigational) and may be denied.

Product Coding

Covered products (brand names listed)mixedCovered

Novarel	chorionic gonadotropin (brand)
Pregnyl	chorionic gonadotropin (brand)
Ovidrel	choriogonadotropin alfa (brand)

Covered products (brand names listed) - neutralmixed

chorionic gonadotropin

hCG (class name)

Provider Actions & Authorization

Prior Authorization

Authorization period

Authorization durations: up to 12 months for induction of oocyte maturation and/or assisted reproductive technology (ART) when criteria met; up to 6 months for prepubertal cryptorchidism; up to 12 months for hypogonadotropic hypogonadism when criteria met (see required lab documentation).

Induction of oocyte maturation and/or release: Authorization up to 12 months.
Prepubertal cryptorchidism: Authorization up to 6 months.
Hypogonadotropic hypogonadism: Authorization up to 12 months when criteria met — see documentation requirements.

Documentation Required

Required lab documentation

To initiate prior authorization for hypogonadotropic hypogonadism, submit pretreatment laboratory results for testosterone, follicle stimulating hormone (FSH), and luteinizing hormone (LH).

Background

Chorionic gonadotropin (hCG) products are used to induce final follicular maturation and ovulation in assisted reproductive technology and in selected anovulatory infertility, to treat prepubertal cryptorchidism, and to stimulate gonadal function in hypogonadotropic hypogonadism. Appropriate pretreatment with follicle‑stimulating hormones is required for some ART uses. Use is covered only for the FDA‑approved indications and the specified compendial uses; all other indications are considered experimental/investigational and not medically necessary.

Definitions

Compendial use

DefinitionCompendial use refers here to infertility and luteal phase support as covered uses.

ScopeApplies to infertility treatment and luteal phase support when approval criteria are met.

Coverage implicationUses listed as compendial (infertility, luteal phase support) are considered covered; all other non‑listed indications are experimental/investigational and not medically necessary.

Hypogonadotropic hypogonadism

DefinitionHypogonadotropic hypogonadism is hypogonadism secondary to pituitary deficiency.

PopulationConsidered for treatment in selected males (per Novarel/Pregnyl FDA indications).