Where this LCD applies
Each contract number is a jurisdiction on the remittance; the policy binds claims processed under these contracts and no others.
Billing and coding: diagnoses and procedure codes
Since 2019 the codes live in the companion article rather than the LCD. Billing and Coding A57615 (Billing and Coding: Treatment of Males with Low Testosterone) carries the diagnosis and procedure lists the contractor loads as the claims edit. CPT codes are shown as bare numbers because the descriptors are licensed by the AMA; HCPCS Level II descriptors are public and shown.
A57615: Billing and Coding: Treatment of Males with Low Testosterone (Billing and Coding, effective 2025-10-16)
- Covered ICD-10-CM codes
- 11
- 1 group
- Non-covered ICD-10-CM codes
- 0
- Procedure codes listed
- 7
- Full article
- cms.gov record
| ICD-10-CM | Description (FY2027) |
|---|---|
| D35.2 | — |
| D44.3 | — |
| E23.0 | — |
| E23.1 | — |
| E23.3 | — |
| E23.6 | — |
| E23.7 | — |
| E29.1 | — |
| E29.8 | — |
| E89.5 | — |
| N50.89 | — |
Procedure codes: 11980, 84410, 96372, J1071 (Injection, Testosterone Cypionate, 1 Mg), J3121 (Injection, Testosterone Enanthate, 1 Mg), J3145 (Injection, Testosterone Undecanoate, 1 Mg), J3490 (Unclassified Drugs).
Coverage indications, limitations and medical necessity
Noridian has noted a rapid increase in the use of testosterone supplements that exceed the expected use in the Medicare population based on current published data. According to a Health Technology Assessment on Testosterone Testing from the Washington State Health Care Authority, the presence of low serum testosterone is 9.0% in men aged 45 to 54 years, 16.5% in men aged 55 to 64 years, and 18.3% in men aged 65 to 74 years. These estimates were derived from the National Health and Nutrition Examination Survey III (NHANESIII), which defined low testosterone levels as is not necessarily a disease and may be asymptomatic and / or may be related or associated with many chronic illnesses. “Low T Syndrome” or “Low T” is not a syndrome and may be an incidental finding or lab error. Low serum testosterone alone does not constitute a diagnosis of androgen deficiency or clinical hypogonadism. Diagnosis of a clinical condition requires the presence of certain characteristic symptoms as well as an abnormally low serum testosterone.
Many of the symptoms are not specific to, and not directly correlated to specific levels of testosterone. Guidelines from the Endocrine Society suggest some of the following symptoms may be related to low serum testosterone but may also have many other causes in the elderly population:
More Specific Signs / Symptoms
• Incomplete or delayed sexual development; eunuchoidism
• Reduced sexual desire (libido) and activity
• Breast discomfort, gynecomastia
• Loss of body (axillary and pubic) hair, reduced shaving
• Very small (Especially
• Inability to father children
• Low or zero sperm count
• Height loss, low-trauma fracture, low bone mineral density
• Hot flushes, sweats
Less Specific Signs/Symptoms
• Decreased energy, motivation, initiative and self confidence
• Feeling sad or blue, depressed mood, dysthymia
• Poor concentration and memory
• Sleep disturbance, increased sleepiness
• Mild anemia
• Reduced muscle bulk and strength
• Increased fat or increased body mass index
• Diminished physical or work performance
Noridian expects that the evaluation of primary hypogonadism be undertaken with at least 2 separate serum testosterone levels taken on two different days in the morning (when testosterone secretion is highest) , and / or two morning levels of “free” or bioavailable testosterone) and LH or FSH levels. Elevated LH /FSH confirms primary hypogonadism and the potential need for replacement hormone. If the two testosterone determinations are low AND the LH/FSH levels are also low, pituitary disease (including a serum prolactin) or chronic diseases should be assessed before making a diagnosis of age related low testosterone. Only patients with low testosterone associated significant symptoms should be considered for treatment. A comprehensive examination is required to evaluate for medications or chronic diseases known to cause decreased energy, memory problems, impotence and mental health problems.
Noridian would consider the low testosterone related symptoms from the nonspecific and specific groups described above to be documented in the chart along with two low testosterone levels drawn on two mornings and a single LH or FSH to demonstrate the need for testosterone therapy in the age related group of symptomatic androgen deficiency. Documentation of the symptoms, signs, physical examination and lab tests must be available in the chart if requested.
Treatment of symptoms associated with low testosterone is controversial. It is not certain if low testosterone is the cause of the symptoms, a marker for underlying chronic diseases, or the effect of the symptoms-and there is a considerable placebo effect. Long term effects of testosterone on the geriatric population are mixed but are being studied by the NIH. Long term use of testosterone can damage the hypothalamic-pituitary-testicular axis and lead to permanent testicular failure.
Testosterone replacement therapy is contraindicated in patients with breast cancer and untreated prostate cancer. There are recent FDA listed warnings about thromboembolic disease, increase in erythrocythemia, and hypertension. The clinical records shall reflect that these issues were discussed with the patient before initiating therapy. Some physicians recommend obtaining baseline PSA testing and ongoing monitoring to test for prostate cancer.
Long term testosterone therapy will shrink testicular tissue and can lead to infertility, and therefore would be contraindicated in those interested in reproduction.
Where replacement is indicated, the dose of replacement therapy should be the least amount necessary to obtain a serum testosterone in the low normal range. Testosterone replacement can be administered by many routes. The current preferred routes are by transdermal preparations. Since topical or transdermal agents are administered daily in low dose, the risk of supraphysiological or subtherapeutic levels is minimized. The use of topical agents is thought to minimize adverse events. Indeed, in series examining the toxicity of topical agents, adverse events are nearly nonexistent when administered by these routes (Steidle et al., 2003). The main disadvantage of the topical agents are their high cost ($100 to $150 per month), substantially higher than self-administered injection therapy, and the potential risk of inadvertent transfer of hormone to women or children through skin contact. There is no evidence that unusually high doses-or higher than published frequencies of administration-are any more effective than doses established by the FDA and could lead to increased side effects. Ongoing monitoring of hormone levels and side effects are necessary.
Summary of evidence (opening)
N/A
the full summary and analysis of evidence are in the CMS record.
Dates, lineage and related policies
- Original determination effective
- 2016-07-12
- Current revision effective
- 2025-10-16
- Last reviewed by the contractor
- 2021-03-02
- MCD version
- 22
Other related documents: A55056 (Billing and Coding), A55053 (Response to Comments), A55055 (Response to Comments).
Using this policy on a claim
Match the documented indication to the covered indications above before the service is scheduled, carry a diagnosis from the article's covered list on the claim line, and keep the elements the documentation section asks for in the record, because the contractor can request it later through medical review. A denial under this policy arrives as CARC 50 with remark N115; the LCD lookup guide walks through the appeal path and the Advance Beneficiary Notice rules, and the Noridian Healthcare Solutions, LLC hub lists every other active policy from the same contractor.
The same policy title at other contractors
Contractors often adopt each other's policies and then revise them separately, so the criteria and the diagnosis lists drift apart. The topic comparison lines up every version.
Frequently asked questions
What does LCD L36538 cover?
Noridian has noted a rapid increase in the use of testosterone supplements that exceed the expected use in the Medicare population based on current published data. According to a Health Technology Assessment on Testosterone Testing from the Washington State Health Care Authority, the presence of low serum testosterone is 9.0% in men aged 45 to 54 years, 16.5% in men aged 55 to 64 years, and 18.3% in men aged 65 to… The full indications and limitations are reproduced on this page from the CMS Medicare Coverage Database export of September 24, 2026.
Which states does LCD L36538 apply to?
Noridian Healthcare Solutions, LLC applies it to Medicare claims in AK, AS, AZ, CA, CNMI, GU, HI, ID, MT, ND, NF, NV, OR, SD, SF, UT, WA, WY. A Local Coverage Determination binds only the contractor that wrote it; the same service in another jurisdiction is judged under that contractor's own policy or, where none exists, claim by claim.
Which diagnosis codes support medical necessity under LCD L36538?
The companion billing and coding article A57615 lists 11 ICD-10-CM codes in 1 group that support medical necessity; the first 11 appear on this page and the complete list is in the article on cms.gov.
How do I appeal a denial under LCD L36538?
The remittance carries claim adjustment reason code 50 with remark code N115, naming the LCD. Compare the documented indication with the policy's covered indications and the article's diagnosis list, then file a redetermination within 120 days with the record attached; if the service genuinely falls outside the policy, the patient can be billed only when a valid Advance Beneficiary Notice was obtained before the service.
Sources
Every figure on this page is taken from the CMS publications below, as released by the Centers for Medicare & Medicaid Services. Projection built 2026-10-02. Verify against the primary file before billing or contracting decisions.
- Medicare Coverage Database, current LCD exportVersion MCD release 2026-09-24 · effective 2026-09-20 · file lcd.csvSHA-256 2fcc4251b6ddd1eb…
- Medicare Coverage Database, current Billing and Coding Articles exportVersion MCD release 2026-09-24 · effective 2026-09-20 · file article.csvSHA-256 f31932f1df3b4035…
- ICD-10-CM FY2027 code descriptionsVersion FY2027 · effective 2026-10-01 · file icd10cm_codes_2027.txtSHA-256 3c0583a38ee0e848…
Disclaimer
The policy text and code lists are reproduced from the CMS Medicare Coverage Database export as an operational reference. Verify against the current LCD and article on cms.gov before billing; coverage depends on the full record and the contractor. Not legal, clinical or billing advice.