Implantable Hormone Pellets
Customize your policy alerts
Sign up for Aetna Policy 0345 alerts
Get alerted when Policy 0345 changes without checking for updates manually.
Monitor payer policy activity
Defines Aetna's coverage stance for implantable hormone pellets (estradiol, testosterone, progestin/progesterone), including medically necessary indications for testosterone pellets and investigational/noncovered uses. Applies to Aetna members and providers submitting claims for these implants.
No material clinical or coverage changes in this revision.
Coverage Criteria for Implantable Hormone Pellets
inv-01: Initial medically necessary indications for testosterone pellets
Aetna considers testosterone propionate implant pellets (Testopel) medically necessary for any of the following indications when the criteria below are met:
Medically necessary indications
- Gender dysphoria criteria: Member has a diagnosis of gender dysphoria; and member is able to make an informed decision to engage in hormone therapy; and member's comorbid conditions are reasonably controlled; and member has been educated on contraindications and side effects to therapy; and before the start of therapy the member has been informed of fertility preservation options; and for members <18, medication prescribed by or in consultation with a provider specialized in care of transgender youth who has collaborated care with a mental health care provider, and member has reached or previously reached Tanner stage 2 or greater.
All listed gender dysphoria conditions must be met
- Primary or hypogonadotropic hypogonadism criteria: Before the start of testosterone therapy, member has at least two confirmed low morning testosterone levels according to current practice guidelines or laboratory reference values; OR for continuation of testosterone therapy, before the member started therapy the member had a confirmed low morning testosterone level according to current practice guidelines or laboratory reference values.two low morning testosterone levels (initial) or prior confirmed low morning level (continuation)
Documentation of low serum testosterone is not required after bilateral orchiectomy
inv-02: Experimental / Investigational (Testosterone)
Aetna considers implantable testosterone pellets experimental and investigational for the following (not an all-inclusive list):
Effectiveness has not been established for these indications.
inv-03: Experimental / Investigational (Estradiol, Progestin)
Aetna considers implantable estradiol pellets and progestin/progesterone pellets experimental and investigational because effectiveness and safety have not been established for the listed uses:
FDA compassionate IND programs for estrogen pellets have been terminated.
inv-04: Laboratory confirmation for testosterone replacement
Covered when ALL of the following laboratory documentation criteria are met to establish androgen deficiency:
Use laboratory reference ranges where available; documentation exceptions apply (e.g., bilateral orchiectomy).
Use of implantable hormone pellets for indications where effectiveness has not been established is considered experimental, investigational, or not covered. Examples include age-related (late‑onset) hypogonadism, idiopathic hypogonadism not due to disorders of the testicles, pituitary gland, or brain, male menopause, pain management in women, treatment of various cancers (e.g., breast, kidney, prostate), and treatment of symptoms associated with menopause as an unlabeled/unsubstantiated use. Progestin/progesterone pellets are likewise considered experimental/investigational for indications such as dysmenorrhea and erythema nodosum because effectiveness has not been established.
Androgen therapy is contraindicated in persons with a diagnosis of prostate cancer or breast cancer. These diagnoses are specifically listed among conditions for which implantable hormone pellet therapy is not appropriate, and corresponding ICD‑10 codes (for example, C61 for malignant neoplasm of prostate and malignant neoplasm of breast codes C50.011–C50.929) are identified as not covered for indications in this Clinical Policy Bulletin.
This Clinical Policy Bulletin is developed to assist in administering plan benefits and does not constitute an offer of coverage or medical advice. It contains a general description of plan or program benefits and is not a contract; the bulletin may be updated and is subject to change. Providers are responsible for clinical care and should consult plan‑specific documents and authorization resources for current coverage and prior authorization requirements.
Implantable estradiol pellets are considered experimental and investigational because they are not FDA‑approved in the U.S., and available evidence indicates unpredictable and fluctuating serum estrogen concentrations and insufficient established safety and effectiveness for listed uses. Many other off‑label uses of testosterone or progestin/progesterone pellets (for example, treatment of menopausal symptoms, non‑endocrine indications, or conditions listed above) are likewise considered not medically necessary or investigational.
Androgen therapy should not be prescribed in the absence of proven androgen deficiency. In line with consensus guidance, testosterone replacement is not recommended for older men per se, men with chronic non‑gonadal disease, or for treatment of non‑specific symptoms unless objective laboratory evidence of deficiency is documented. Contraindications and precautions (including oncology contraindications) should be considered prior to initiation.
Procedure, HCPCS, and Diagnosis Codes
| 11980 | Subcutaneous hormone pellet implantation (implantation of estradiol and/or testosterone pellets beneath the skin) [covered for testosterone only - not estradiol]. |
| 20700 | Manual preparation and insertion of drug-delivery device(s), deep (eg, subfascial) (List separately in addition to code for primary procedure). |
| 11981 | Insertion, non-biodegradable drug delivery implant [not covered when used to implant progestin/ progresterone pellets]. |
| 80414 | Chorionic gonadotropin stimulation panel; testosterone response. |
| 80415 | estradiol response. |
| 84402 | Testosterone; free. |
| 84403 | total. |
| 84410 | Testosterone; bioavailable, direct measurement (eg, differential precipitation). |
| S0189 | Testosterone pellet, 75mg. |
| E23.0 | Hypopituitarism [hypogonadotropic hypogonadism] [not covered for androgen deficiency due to aging or idiopathic hypogonadism not due to disorders of the testicles, pituitary gland or brain]. |
| E29.1 | Testicular hypofunction [primary] [not covered for androgen deficiency due to aging or idiopathic hypogonadism not due to disorders of the testicles, pituitary gland or brain]. |
| E30.0 | Delayed puberty [congenital or acquired endogenous androgen absence or deficiency]. |
| F64.0 - F64.9 | Gender identity disorders. |
| Z87.890 | Personal history of sex reassignment. |
| C50.011 – C50.929 | Malignant neoplasm of breast. |
| C61 | Malignant neoplasm of prostate. |
| C64.1 – C64.9 | Malignant neoplasm of kidney, except renal pelvis. |
| L52 | Erythema nodosum. |
| N50.89 | Other specified disorders of male genital organs [male menopause]. |
| N91.0 - N93.9 | Disorders of menstruation and other abnormal bleeding. |
| N94.4 - N94.6 | Dysmenorrhea. |
| N95.0 - N95.9 | Menopausal and other perimenopausal disorders. |
| Z85.43 | Personal history of malignant neoplasm of ovary |
Provider Actions, Prior Authorization, and Documentation
Prior Authorization Required
Prior authorization is required for testosterone pellet implantation (CPT 11980; HCPCS S0189). Provide documentation of the clinical indication and required laboratory proof (see items). Failure to include required lab documentation may result in denial.
- Prior authorization required for implantation of testosterone pellets (CPT 11980; HCPCS S0189).
- Include clinical indication supporting medical necessity (e.g., primary or hypogonadotropic hypogonadism, delayed puberty, or gender dysphoria when criteria met).
- Failure to submit required laboratory documentation (see documentation callout) risks claim denial.
Laboratory Documentation Requirement
Documentatory proof of androgen deficiency is required for authorization except where noted (bilateral orchiectomy). Two consecutive fasting morning testosterone measurements are required as specified below. If total testosterone is <150 ng/dL (severe deficiency), one fasting morning total testosterone may suffice. Testosterone levels should not be measured during acute or subacute illness.
- Laboratory proof required for authorization: two consecutive fasting morning samples between 7:00 and 10:00 on different days.
- Acceptable tests: total testosterone (preferred); if total is low-normal (301–399 ng/dL), provide two consecutive low free or bioavailable fasting serum testosterone levels.
- One fasting morning total testosterone is sufficient when total <150 ng/dL (severe deficiency).
- Do not measure levels during acute/subacute illness; use reference laboratory ranges to interpret results.
Provider Actions — Therapy Considerations and Step Therapy
Implantable testosterone pellets are considered a second-line replacement therapy option. Initiate testosterone therapy only after androgen deficiency has been demonstrated by laboratory assays and after counseling regarding risks, contraindications, and fertility preservation when applicable. There are no specified step-therapy requirements in this policy.
- Implantable testosterone pellets may be used as second-line testosterone replacement therapy after proven androgen deficiency.
- Initial therapy considerations: start therapy only after at least two confirmed low morning testosterone levels (or as noted for severe deficiency); tailor maintenance modality (injections, implants, capsules) to patient needs.
- No step therapy requirements specified in this policy.
Coverage Limits, Documentation, and Administrative Information
Procedures or indications outside the listed medically necessary testosterone indications (e.g., age-related hypogonadism, idiopathic hypogonadism not due to testicular/pituitary/brain disorders, treatment of menopause symptoms, cancer treatment, pain management in women) are not covered. Administrative links for policy history and additional information are available in the policy header.
- Procedures/indications outside the listed medically necessary testosterone indications are not covered.
- Documentation for primary or hypogonadotropic hypogonadism: two confirmed low morning levels per current practice guidelines or lab reference ranges.
- Administrative: see policy history and Clinical Policy Bulletin Notes for updates; this policy is not a contract and may be updated.
Background and Rationale
Implantable estradiol pellets are not FDA‑approved in the United States and have been judged to produce unpredictable, fluctuating serum estrogen concentrations; therefore their safety and effectiveness for the listed indications have not been established. For testosterone implants, Aetna requires objective laboratory confirmation of androgen deficiency (see laboratory criteria), and clinical guidance notes that therapy should be initiated only after deficiency is proven and that implants carry unique risks (for example, site infection, extrusion) and general risks of androgen therapy (cardiovascular, thromboembolic, hepatic, prostatic, and effects on fertility).
Definitions and Key Terms
OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.