J3145 — Injection, testosterone undecanoate, 1 mg
HCPCS/CPT
Prior Authorization
No Prior Auth Required
Code is covered without prior authorization (high confidence)
Medicare Pricing
Work RVU
0.00
Facility
N/A
Non-Facility
N/A
Documentation Required
- This billing and coding guidance must be used in conjunction with the associated Local Coverage Determination (LCD).
- The patient's medical record must document medical necessity, including relevant medical history, physical examination, and results of pertinent diagnostic tests or procedures.
- For services requiring a referring/ordering physician, the referring/ordering physician's name and NPI must be reported on the claim.
- A claim submitted without a valid ICD‑10‑CM diagnosis code that best describes the condition will be returned as an incomplete claim under §1833(e) of the Social Security Act.
Key Coverage Criteria
- Medicare may cover injectable testosterone pellets (Testopel) for males when used for an FDA‑approved indication and when the service meets Medicare coverage requirements in CMS Medicare Benefit Policy Manual, Chapter 15, §50.4.3.
- Injectable testosterone pellet therapy may be used when alternative accepted routes (transdermal, oral, nasal, intramuscular) are clinically inappropriate or insufficient and medical necessity is documented.
- Testosterone replacement may be considered for men with clinically significant symptoms of androgen deficiency AND two separate morning serum total testosterone levels low on two different days and a single LH or FSH measurement documented in the chart.
- Primary hypogonadism (low testosterone with elevated LH and/or FSH) is an indication for consideration of testosterone replacement therapy when documented with symptoms and lab results.
- If two low morning testosterone determinations are present together with low LH/FSH, testosterone therapy may be considered only after evaluation and exclusion of pituitary disease (including serum prolactin) or chronic disease as the cause of hypogonadism.
- Only patients with low testosterone associated significant symptoms should be considered for treatment.
14 Active Policies
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A57615 — Billing and Coding: Treatment of Males with Low Testosterone
A58828 — Billing and Coding: Treatment of Males with Low Testosterone
L39086 — Treatment of Males with Low Testosterone
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