CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Testosterone Transdermal Gel (1%) — Coverage Criteria

Criteria and quantity limits for authorization of testosterone transdermal gel 1% for members with primary or hypogonadotropic hypogonadism or gender dysphoria under the Medicaid scope of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTestosterone Transdermal Gel (1%) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateDec 1, 2017

Next Review DateN/A

Key ActionObtain prior authorization for up to 12 months when the member meets laboratory and prior-treatment criteria, including required documentation of confirmed low testosterone and trial or intolerance/contraindication to formulary injectable testosterone.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization period when criteria met

150 gm/30dquantity limit - pump

300 gm/30dquantity limit - 5 gm

Medicaidpopulation/scope

Coverage Criteria for Testosterone Transdermal Gel (1%)

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTestosterone Transdermal Gel (1%) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateDec 1, 2017

Next Review DateN/A

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Primary or hypogonadotropic hypogonadism (Initial and Continuation)

Authorization of 12 months may be granted when ALL of the following are met:

Diagnosis: The requested formulary drug is being prescribed for primary or hypogonadotropic hypogonadism.

Safety and efficacy of testosterone products in patients with age-related (late-onset) hypogonadism have not been established.

Baseline testosterone: Either: (a) before the start of testosterone therapy the patient has at least two confirmed low testosterone levels according to current practice guidelines or the laboratory's standard reference values; OR (b) for continuation of testosterone therapy: before the patient started testosterone therapy, the patient had a confirmed low testosterone level according to current practice guidelines or the laboratory's standard reference values.two confirmed low levels for new starts; one confirmed low level for continuation

Step therapy requirement: Patient has experienced an inadequate treatment response, intolerance, or contraindication to formulary injectable testosterone (testosterone cypionate or testosterone enanthate).

Gender dysphoria

Authorization of 12 months may be granted when ALL of the following are met:

Diagnosis and capacity: The requested formulary drug is being prescribed for gender dysphoria in a patient who is able to make an informed decision to engage in hormone therapy.

Use of testosterone for age-related (late-onset) hypogonadism is noted in the policy as having unestablished safety and efficacy. The policy requires confirmation of low testosterone before initiation: for new therapy starts, at least two confirmed low testosterone levels per current practice guidelines or facility reference values; for continuation cases, documentation that the patient had a confirmed low testosterone level prior to the original start of therapy.

Therapy specifically for age-related (late-onset) hypogonadism without demonstration of low testosterone per current practice guidelines is not supported by this policy, because safety and efficacy in this population have not been established and the policy requires guideline-based laboratory confirmation before approving therapy.

Coding and Quantity Limits

Quantity-limited product (pump)NDC|GPICovered

GPI 23100030004040

Testosterone transdermal gel pump 12.5 mg/act (1%)

Quantity-limited product (single-dose packets)NDC|GPICovered

GPI 23100030004030

Testosterone transdermal gel 5 gm (1%)

inv-07: Quantity limit - pump — 150 gm per 30 days

ProductTestosterone transdermal gel pump 12.5 mg/act (1%) — GPI 23100030004040

Quantity limit150 gm per 30 days

Coverage statusQuantity-limited (covered)

inv-08: Quantity limit - 5 gm — 300 gm per 30 days

ProductTestosterone transdermal gel 5 gm (1%) — GPI 23100030004030

Quantity limit300 gm per 30 days

Coverage statusQuantity-limited (covered)

Provider Requirements and Prior Authorization

Prior Authorization

Prior authorization required for 12 months

Prior authorization for up to 12 months is required when the member meets the stated laboratory and prior‑treatment criteria.

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

Step Therapy

Injectable testosterone required first

Step therapy requires that the member have an inadequate treatment response, intolerance, or contraindication to formulary injectable testosterone (e.g., testosterone cypionate or testosterone enanthate) before non‑injectable formulations will be approved.

Formulary injectable testosterone (testosterone cypionate or testosterone enanthate) must be tried and shown to be ineffective, not tolerated, or contraindicated prior to approval of other testosterone formulations.

Documentation Required

Required clinical documentation

Documentation must include confirmed low testosterone levels per current practice guidelines or facility reference values. For initiation, at least two documented low total testosterone measurements prior to starting therapy; for continuation, documentation of a prior confirmed low level before therapy was started.

At least two confirmed low testosterone levels prior to initiation (per current practice guidelines or lab reference values).
For continuation requests: documentation that a confirmed low testosterone level was present prior to initiation of therapy.

Denial Risk

Missing baseline labs or prior trial

Requests missing baseline laboratory documentation or evidence of a prior trial of formulary injectable testosterone (or documentation of intolerance/contraindication) may be denied for lack of required information.

Missing documentation of at least two confirmed low testosterone levels prior to initiation (or a confirmed low level prior to initiation for continuation) may result in denial.
Missing documentation of an inadequate response, intolerance, or contraindication to formulary injectable testosterone may result in denial.

Background

Primary hypogonadism and hypogonadotropic hypogonadism are clinical conditions characterized by clinically low testosterone that may require replacement therapy when confirmed by laboratory testing. Authorization of up to 12 months may be granted when the drug is prescribed for one of these diagnoses, the baseline testosterone requirement is met (new starts: two confirmed low levels; continuations: one confirmed low level documented prior to the original start), and the patient has had an inadequate response, intolerance, or contraindication to formulary injectable testosterone (testosterone cypionate or testosterone enanthate).

Definitions

inv-14: Confirmed low testosterone level

DefinitionA testosterone measurement(s) considered low according to current practice guidelines or the laboratory's standard reference values.

New starts requirementAt least two confirmed low testosterone levels prior to initiation per current practice guidelines or lab reference values.

Continuation requirementFor continuation, documentation that the patient had a confirmed low testosterone level prior to starting therapy.

inv-15: Inadequate treatment response/intolerance/contraindication to injectable testosterone

DefinitionClinical documentation that the member did not respond to, could not tolerate, or has a medical reason preventing use of formulary injectable testosterone (testosterone cypionate or testosterone enanthate).

Required for approvalDocumentation of inadequate response, intolerance, or contraindication to formulary injectable testosterone is required before approving transdermal gel.

Applies toBoth primary/hypogonadotropic hypogonadism and gender dysphoria coverage pathways.