CurrentAgency for Health Care AdministrationPolicy N/A

Chorionic Gonadotropin (Pregnyl® and Novarel®)

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This policy governs prior authorization and coverage criteria for Pregnyl and Novarel (chorionic gonadotropin). Coverage is limited to patients meeting age and diagnostic criteria for prepubertal cryptorchidism or hypogonadotropic hypogonadism; requests for fertility treatment or weight loss must be denied.

Policy Summary

PayerAgency for Health Care Administration

PolicyChorionic Gonadotropin (Pregnyl® and Novarel®)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and confirm the patient is at least 4 years old with a covered diagnosis before treatment.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4 yearsMinimum patient age

6 monthsMaximum authorization duration

2Covered diagnostic indications

2Explicitly denied uses

10,000 USP

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CurrentAgency for Health Care AdministrationPolicy N/A

Chorionic Gonadotropin (Pregnyl® and Novarel®)

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Sign up for all Agency for Health Care Administration policy alerts

Know when Agency for Health Care Administration releases new policies or updates existing guidance.

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Policy Summary

PayerAgency for Health Care Administration

PolicyChorionic Gonadotropin (Pregnyl® and Novarel®)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and confirm the patient is at least 4 years old with a covered diagnosis before treatment.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4 yearsMinimum patient age

6 monthsMaximum authorization duration

2Covered diagnostic indications

2Explicitly denied uses

10,000 USP

Coverage Criteria

Initial Coverage Eligibility

Covered when all of the following are met:

Eligibility

Minimum age: Patient is a minimum of 4 years of age.>= 4 years
Covered diagnosis
- Prepubertal cryptorchidism: Diagnosis of prepubertal cryptorchidism.
- Hypogonadotropic hypogonadism: Diagnosis of hypogonadotropic hypogonadism.

Coverage for prepubertal cryptorchidism applies only when the condition is not due to anatomical obstruction.

Requests for fertility treatment, including ovulation induction, or for weight loss related to obesity are excluded and must be denied.

Provider Actions

Prior Authorization

Prior Authorization Required

Prior authorization is required for chorionic gonadotropin. Approved authorization may be granted for up to six months.

Denial Risk

Noncovered Fertility and Weight-Loss Use

Requests related to fertility treatment, including ovulation induction, or weight loss related to obesity must be denied.

Documentation Required

Age and Diagnosis Requirements

Coverage requires that the patient meet both the minimum age and diagnosis requirements.

Clinical Background

Chorionic gonadotropin is used in selected pediatric patients with prepubertal cryptorchidism and in selected males with hypogonadotropic hypogonadism. The policy specifies intramuscular dosing regimens for these indications and excludes fertility treatment and obesity-related weight-loss use.

Definitions

Prepubertal cryptorchidism

IndicationPrepubertal cryptorchidism

ExclusionThe condition must not be due to anatomical obstruction.

Typical treatment ageTherapy is usually instituted in children between 4 and 9 years of age.

Hypogonadotropic hypogonadism

IndicationSelected cases of hypogonadotropic hypogonadism in males

Regimen 1500 to 1,000 USP Units intramuscularly three times a week for three weeks, followed by the same dose twice a week for three weeks.

Regimen 2

Initial Therapy Criteria

Initial Therapy Eligibility

Initial therapy requires meeting all listed eligibility criteria.

Initial therapy eligibility: Patient is at least 4 years old and has prepubertal cryptorchidism or hypogonadotropic hypogonadism.Age >= 4 years

Fertility-treatment and weight-loss requests must be denied.

Site of Care and Administration

Billing Rule

Administer by intramuscular injection

Administer chorionic gonadotropin by intramuscular injection in the office setting.