Human Chorionic Gonadotropin

POLICY NUMBER

L.5.01.436

Novarel (gonadotropin, chorionic)

Ovidrel (choriogonadotropin alfa)

Pregnyl (choriogonadotropin alfa)

Please perform a formulary drug search on your patient’s member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific member’s benefit plan.

DESCRIPTION

Human chorionic gonadotropin (HCG) is a hormone produced by the human placenta. HCG's action is virtually identical to pituitary LHs, although HCG appears to have a small degree of FSH activity as well. It stimulates production of gonadal steroid hormones by stimulating interstitial cells of testis to produce androgens, and the corpus luteum of the ovary to produce progesterone. Androgen stimulation in males leads to development of secondary sex characteristics and may stimulate testicular descent when no anatomical impediment is present. During the normal menstrual cycle, LH participates with FSH in development and maturation of the normal ovarian follicle, and the mid-cycle LH surge triggers ovulation; HCG can substitute for LH in this function. During a normal pregnancy, HCG secreted by the placenta maintains the corpus luteum after LH secretion decreases, supporting continued estrogen and progesterone secretion and preventing menstruation.

Novarel (gonadotropin, chorionic kit) and Pregnyl (choriogonadotropin alfa kit) are indicated for treatment of prepubertal cryptorchidism not due to anatomic obstruction, selected cases of hypogonadotropic hypogonadism (hypogonadism secondary to a pituitary deficiency) in males, and induction of ovulation and pregnancy in the anovulatory, infertile woman in whom the cause of anovulation is secondary and not due to primary ovarian failure, and who has been appropriately pretreated with human menotropins.

Ovidrel (choriogonadotropin alfa injection) is indicated for the induction of final follicular maturation and early luteinization in infertile women who have undergone pituitary desensitization and who have been appropriately pretreated with follicle stimulating hormones as part of an Assisted Reproductive Technology (ART) program such as in vitro fertilization and embryo transfer and for the induction of ovulation (OI) and pregnancy in anovulatory infertile patients in whom the cause of infertility is functional and not due to primary ovarian failure.

POLICY

Prior authorization is required.

The use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements.

Novarel (gonadotropin, chorionic kit) and Pregnyl (choriogonadotropin alfa kit) may be considered medically necessary for the following:

1. Hypogonadism secondary to a pituitary deficiency; OR

2. Prepubertal cryptorchidism not due to anatomical obstruction.

Length of Approval:

Hypogonadism: 12 monthsCryptorchidism: 4 months

Human chorionic gonadotropin (HCG) is non-covered for the following:

1. Services and supplies related to infertility, artificial insemination, intrauterine insemination and in-vitro fertilization regardless of any claim of Medical Necessity

2. For treatment related to sex transformations, sexual function, sexual dysfunctions or inadequacies regardless of Medical Necessity.

POLICY EXCEPTIONS

State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A.  consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B.  appropriate with regard to standards of good medical practice; and

C.  not solely for the convenience of the Member, his or her Provider; and

D.  the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

POLICY HISTORY

5/1999: Approved by Pharmacy & Therapeutics (P&T).

1/30/2002: Prior authorization deleted.

4/24/2002: Type of Service and Place of Service deleted. Code Reference section completed, CPT code 80414, 83001, 83002, 84403, 84702, 84703, 90782 added covered codes, ICD-9 procedure code 99.24, 99.29 added covered codes, ICD-9 diagnosis code 176.0-176.9, 253.4, 256.39, 257.2, 752.51 added covered codes, HCPCS J0725 added covered codes, ICD-9 diagnosis code 607.84, 783.21 added non-covered codes.

11/19/2004: Code Reference section updated, CPT code 80414, 83001, 83002, 84403, 84702, 84703, 90782 deleted covered codes, ICD-9 procedure code 99.29 deleted covered codes, ICD-9 diagnosis code range 176.0-176.9 listed separately, non-covered table deleted, ICD-9 diagnosis code 607.84, 783.21 deleted non-covered codes.

10/29/2006: Dosing and off-label information removed.

11/2/2006: Code Reference section updated. ICD-9 Diagnosis codes 176.0-176.5, 176.8, 176.9 deleted from policy.

04/01/2014: Policy title changed from "Human Chorionic Gonadotropin (A.P.L®, Chorex-5®, Chorex-10®, Profasi®, Choron 10®, Gonic®, Pregnyl®)" to "Human Chorionic Gonadotropin." Policy description updated to include brand names "Novarel® and Ovidrel®." Policy statement updated to add "secondary to a pituitary deficiency" to the medically necessary statement.

08/27/2015: Policy guidelines updated to add contract exclusion language and the definition of medically necessary. Code Reference section updated to add ICD-10 codes and to remove ICD-9 diagnosis code 256.39.

05/26/2016: Policy number L.5.01.436 added.

06/13/2016: Approved by Pharmacy & Therapeutics (P&T) Committee.

05/16/2017: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee.

03/27/2018: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee.

08/07/2020: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Added statement to perform a formulary drug search on the patient's member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific member's benefit plan. Policy section updated to add that prior authorization is required and that the use of samples by a Member will not be considered current or stable therapy for purposes of Medical Policy review. Medically necessary criteria updated. Added statement that human chorionic gonadotropin is non-covered for the criteria listed. Policy Guidelines updated to remove information regarding benefits. Sources updated.

02/01/2023: Policy Exceptions updated to add the following: State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.

04/12/2024: Policy title changed from "Human Chorionic Gonadotropin (Pregnyl®, Novarel®, Ovidrel®)" to "Human Chorionic Gonadotropin."

06/03/2025: Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee. Policy description updated regarding indications for Novarel (gonadotropin, chorionic kit), Pregnyl (choriogonadotropin alfa kit), and Ovidrel (choriogonadotropin alfa injection). Policy statement revised to state that the use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements. Medically necessary statement revised to replace "Human chorionic gonadotropin (HCG)" with "Novarel (gonadotropin, chorionic kit) and Pregnyl (choriogonadotropin alfa kit)." Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity." Sources updated.

SOURCE(S)

1. Docimo SG, Silver RI, Cromie W. The undescended testicle: diagnosis and management. Am Fam Physician. 2000;62(9):2037?2048.

2. Novarel prescribing information. Ferring Pharmaceuticals Inc. November 2024. Last accessed March 2025.

3. Ovidrel prescribing information. EMD Serono, Inc. December 2023. Last accessed March 2025.

4. Pregnyl prescribing information. Merck Sharp & Dohme LLC. November 2024. Last accessed March 2025.

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Covered Codes

CPT copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.