CurrentUnitedHealthcarePolicy N/A

Androgenic Agents — Testosterone Replacement Therapy (TRT) Prior Authorization (Washington)

Prior authorization form and clinical criteria for coverage of androgenic agents (testosterone replacement therapy) for UnitedHealthcare Washington members; affects prescribers requesting TRT.

Policy Summary

PayerUnitedHealthcare

PolicyTestosterone Replacement Therapy (TRT) prior authorization — Washington

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionComplete and fax the TRT Prior Authorization Request Form with required documentation, including two morning testosterone tests and prior medication trials, for review.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2required baseline morning testosterone measurements

50%hematocrit contraindication (%)

6recent major CV event exclusion (months)

5prednisone-equivalent threshold (mg/day)

Coverage Criteria for Testosterone Replacement Therapy

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Coverage criteria

Covered when ALL of the following are met for the requested indication

Indication: Patient has one of the listed diagnoses: primary hypogonadism, hypogonadotropic hypogonadism, HIV-associated weight loss, chronic high-dose glucocorticoid therapy, men with osteoporosis or young men with low-trauma fractures, delayed puberty not secondary to a pathological cause, advancing inoperable metastatic breast cancer, or gender dysphoria (female-to-male).

See condition-specific sections for required supporting documentation.

Prior trials: Patient has failed or is intolerant to preferred androgenic-testosterone agents when applicable and the provider documents previous medication trials in Section D of the form.

Provider must indicate failure/intolerance and list prior agents and reasons for discontinuation.

Laboratory confirmation: Two morning (between 8 a.m. and 10 a.m.) baseline testosterone measurements, at least 1 week apart, demonstrating low testosterone defined as total serum testosterone <300 ng/dL OR total <350 ng/dL AND free serum testosterone <50 pg/mL.Two tests

List dates and times of draws on the form.

Contraindications absent: No contraindications present such as breast cancer or known/suspected prostate cancer, hematocrit >50%, untreated severe obstructive sleep apnea, severe lower urinary tract symptoms, uncontrolled heart failure, a major cardiovascular event in the past 6 months, or uncontrolled/poorly controlled BPH or increased prostate cancer risk.

If any listed contraindication applies, therapy is not appropriate.

Condition-specific criteria: Condition-specific documentation requirements are met: for primary hypogonadism document testicular failure cause (e.g., orchidectomy, Klinefelter syndrome); for hypogonadotropic hypogonadism document pituitary/hypothalamic causes; for HIV-associated weight loss document <90% ideal body weight or >10% weight loss in 6 months; for chronic glucocorticoid therapy document >5 mg/day prednisone-equivalent for >2 weeks; for delayed puberty document family history, LH/FSH/testosterone measurements, and failed watchful waiting; for metastatic breast cancer TRT is second-line after first-line therapies and prescribed by an oncologist; for transgender care provide DSM-5 diagnosis, informed consent, and prescriber competence documentation.

Complete the applicable section(s) on the form and attach supporting records.

The policy lists specific contraindications and exclusions for testosterone replacement therapy (TRT). Do not initiate TRT in members with breast cancer or known or suspected prostate cancer. Do not approve TRT for members with an elevated hematocrit >50%. TRT is also excluded for members with untreated severe obstructive sleep apnea, severe lower urinary tract symptoms, or uncontrolled or poorly-controlled heart failure. Requests should be denied when the member has had a major cardiovascular event within the past 6 months (for example myocardial infarction, stroke, or acute coronary syndrome). TRT is inappropriate for members with uncontrolled or poorly-controlled benign prostatic hyperplasia or those at higher risk of prostate cancer (for example a rise in PSA after initiating TRT).

The presence of any of the listed contraindications renders TRT inappropriate and is a basis for denying coverage. If documentation shows breast cancer or known/suspected prostate cancer, hematocrit >50%, untreated severe obstructive sleep apnea, severe lower urinary tract symptoms, uncontrolled heart failure, a major cardiovascular event within the past 6 months, or uncontrolled/poorly-controlled BPH or increased prostate cancer risk, the request should be considered not medically necessary and not approved.

Coding and Laboratory Criteria

Diagnosis codes (provider-entered)ICD-10

ICD-10

ICD-10 code to be provided on form (specific codes not listed in document)

Morning testosterone test criteria

Timing and frequencyTwo morning draws between 8:00–10:00 a.m., performed at baseline at least 1 week apart

Total testosterone threshold ATotal serum testosterone <300 ng/dL (10.4 nmol/L)

Total + free threshold BTotal serum testosterone <350 ng/dL (12.1 nmol/L) AND free serum testosterone <50 pg/mL (0.174 nmol/L)

Hematocrit contraindication

Hematocrit contraindicationElevated hematocrit greater than 50% (>50%)

Clinical implicationPresence of hematocrit >50% listed as a contraindication to TRT

Policy actionIf hematocrit >50% is present, therapy is not appropriate and may lead to denial

Glucocorticoid exposure threshold

Glucocorticoid exposure thresholdMore than 5 mg/day of prednisone (or equivalent) for greater than 2 weeks

Documentation requirementIf threshold met, complete Section D documenting exposure and rationale

Applicable indicationUsed to establish glucocorticoid-induced hypogonadism as an approved indication for TRT

Low testosterone definition

Primary definitionLow testosterone defined as total serum testosterone <300 ng/dL (10.4 nmol/L)

Alternate definitionTotal serum testosterone <350 ng/dL (12.1 nmol/L) AND free serum testosterone <50 pg/mL (0.174 nmol/L)

Measurement contextBoth definitions apply to morning (8–10 a.m.) baseline measurements, with two tests at least 1 week apart

Provider Actions and Documentation Requirements

Prior Authorization

Prior authorization required - submit TRT PA form

Prior authorization is required for testosterone replacement therapy. Complete the TRT Prior Authorization Request Form and fax it to 866-940-7328 for review; allow at least 24 hours for a decision.

Step Therapy

Document failure/intolerance to preferred agents

Indicate whether the patient has demonstrated failure or intolerance to preferred androgenic (testosterone) agents and document prior medication trials and reasons for discontinuation in Section D of the form.

Complete Section D (Previous Medication Trials) listing medication name, dates of therapy, and reason for failure/discontinuation.

Documentation Required

Required documentation on PA form

Provide a completed prior authorization form including member and provider information, medication details and directions, diagnosis with ICD-10 code, previous medication trials (Section D), and an explanation why preferred medications would not meet the patient's needs.

Section A: Member and contact information.
Section C: Medication, strength, directions, quantity, diagnosis and ICD-10 code.
Section D: Previous medication trials and reasons for failure.
Section E: Explanation why preferred medications are unsuitable; refer to the patient's PDL.

Documentation Required

Laboratory documentation — two morning testosterone tests

Include two baseline morning testosterone test results drawn between 8–10 a.m., at least one week apart; list the date, time of draw, and report total testosterone and, if performed, free testosterone values.

Record 1st and 2nd testosterone level with date and time on the form.
Low testosterone definition must be met: total <300 ng/dL OR total <350 ng/dL with free <50 pg/mL.

Denial Risk

Denial triggers — missing tests or contraindications

Requests may be denied if the form lacks the required two morning testosterone measurements demonstrating low levels or if listed contraindications are present (e.g., breast cancer or known/suspected prostate cancer, elevated hematocrit >50%, untreated severe OSA, major CV event within 6 months, uncontrolled heart failure or severe LUTS).

Absence of two morning (8–10 a.m.) tests at least 1 week apart demonstrating low testosterone is a denial trigger.
Any checked contraindication on the form (breast/prostate cancer, hematocrit >50%, untreated severe OSA, recent major cardiovascular event in past six months, uncontrolled heart failure, severe lower urinary tract symptoms, or uncontrolled BPH/high prostate cancer risk) may render TRT not medically necessary.

Background

Testosterone replacement therapy (TRT) is indicated for specific, documented diagnoses associated with testosterone deficiency. Covered indications include primary hypogonadism (for example post-orchiectomy or Klinefelter syndrome) and hypogonadotropic hypogonadism (for example pituitary injury or congenital causes) when causative conditions are documented. TRT may be covered for HIV-associated weight loss when weight loss or low body weight criteria are met, for hypogonadism related to chronic high‑dose glucocorticoid therapy (documented exposure >5 mg/day prednisone equivalent for >2 weeks), for certain cases of osteoporosis or low-trauma fractures in men, for delayed puberty after appropriate evaluation, for selected patients with metastatic breast cancer as second-line therapy under oncology direction, and for gender-affirming care (female-to-male) with appropriate DSM-5 diagnosis and provider documentation of competence and consent. Baseline biochemical confirmation with two morning (8–10 a.m.) testosterone measurements at least 1 week apart demonstrating low levels is required prior to approval.

OpenPayer

Androgenic Agents — Testosterone Replacement Therapy (TRT) Prior Authorization (Washington)

Coverage Criteria for Testosterone Replacement Therapy

Coding and Laboratory Criteria

Provider Actions and Documentation Requirements

Background

Definitions