CurrentAetnaPolicy 0345

Implantable Hormone Pellets

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.

Policy Summary

PayerAetna

PolicyImplantable Hormone Pellets

Policy CodePolicy 0345

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain and document two consecutive fasting morning total serum testosterone measurements (or other specified lab criteria) to support medical necessity for testosterone pellet therapy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

11980CPT for pellet implantation

S0189HCPCS for 75 mg pellet

75 mgTestopel strength

2Required morning tests

300 ng/dLTotal T threshold

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.

Policy Summary

PayerAetna

PolicyImplantable Hormone Pellets

Policy CodePolicy 0345

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain and document two consecutive fasting morning total serum testosterone measurements (or other specified lab criteria) to support medical necessity for testosterone pellet therapy.

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.

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:

Estradiol pellets: Implantable estradiol pellets are experimental/investigational due to unpredictable and fluctuating serum estrogen concentrations and lack of established FDA‑approved commercially available formulations in the U.S.

FDA compassionate IND programs for estrogen pellets have been terminated.

Progestin/progesterone pellets are experimental/investigational for the treatment of dysmenorrhea and erythema nodosum because effectiveness has not been established.

inv-04: Laboratory confirmation for testosterone replacement

Covered when ALL of the following laboratory documentation criteria are met to establish androgen deficiency:

Laboratory confirmation: Two consecutive fasting morning total serum testosterone levels below the testing laboratory's normal reference range or below 300 ng/dL; OR for persons with total fasting serum testosterone 300–399 ng/dL, two consecutive low free or bioavailable fasting serum testosterone levels below the laboratory reference range or <225 pmol/L (6 ng/dL); OR one fasting total serum testosterone level if severe deficiency (<150 ng/dL). Samples must be morning (drawn between 7:00 a.m. and 10:00 a.m.) and obtained on different days. Testosterone levels should not be measured during acute or subacute illness.see text

Use laboratory reference ranges where available; documentation exceptions apply (e.g., bilateral orchiectomy).

Procedure, HCPCS, and Diagnosis Codes

Procedure and related codes (covered if selection criteria met)mixedCovered

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.

ICD-10 codes listed as covered if selection criteria metICD-10Covered

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.

ICD-10 codes listed as not covered for indications in CPBICD-10Not Covered

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

inv-13: Confirmed low morning testosterone levels — requirement summary

RequirementAt least two confirmed low morning (fasting) total serum testosterone measurements on different days between 7:00 and 10:00 a.m. prior to initiating testosterone therapy (except after bilateral orchiectomy where not required).

Sample conditionsSamples must be fasting morning specimens obtained on different days between 7:00 and 10:00 a.m.

Continuation therapyFor continuation, documentation that a confirmed low morning testosterone level existed before therapy was started is acceptable.

ExceptionA single morning total testosterone measurement is sufficient if severe deficiency is present (<150 ng/dL).

inv-14: Total serum testosterone thresholds (<300 ng/dL; <150 ng/dL severe)

Low total testosterone thresholdTotal serum testosterone <300 ng/dL is considered low (requires two consecutive fasting morning samples).

Severe deficiency thresholdTotal serum testosterone <150 ng/dL — one fasting morning sample is sufficient to document severe deficiency.

Use of reference rangesLaboratory reference ranges should be used where available; the <300 ng/dL threshold applies when reference ranges are not provided.

inv-15: Free/bioavailable testosterone threshold when total is low-normal

When requiredIf total testosterone is in the low‑normal range (300–399 ng/dL), obtain two consecutive low free or bioavailable fasting testosterone levels to document deficiency.

Free/bioavailable thresholdFree or bioavailable testosterone below the testing laboratory's reference range or <225 pmol/L (6 ng/dL) if reference ranges are not available.

Sample requirementsFree/bioavailable measurements must be fasting morning samples obtained on different days between 7:00 and 10:00 a.m.

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

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.

Documentation Required

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.

Note

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.

Denial Risk

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.

Definitions and Key Terms

inv-29: Gender dysphoria — when testosterone pellets may be medically necessary with listed criteria

IndicationGender dysphoria diagnosis — testosterone pellets may be medically necessary when all listed criteria are met.

Informed decision-makingMember is able to make an informed decision to engage in hormone therapy.

Comorbidity control and educationMember's comorbid conditions are reasonably controlled and member has been educated on contraindications and side effects; member informed of fertility preservation options before start of therapy.

Pediatric requirementFor members <18 years, medication prescribed by or in consultation with a provider specialized in transgender youth care with collaboration of a mental health provider, and member has reached or previously reached Tanner stage 2 or greater.

inv-30: Androgen deficiency (laboratory definition) — two consecutive low fasting totals or alternate criteria

Primary laboratory definitionTwo consecutive fasting morning total serum testosterone levels below the testing laboratory's reference range or below 300 ng/dL (drawn between 7:00 and 10:00 a.m. on different days).

Alternative when total low-normalIf total testosterone is 300–399 ng/dL, two consecutive low free or bioavailable fasting testosterone levels (below reference range or <225 pmol/L/6 ng/dL) are required.

Severe deficiencyOne fasting morning total serum testosterone level is sufficient if <150 ng/dL.

inv-31: Contraindications/precautions — prostate/breast cancer; other precautions listed

Absolute contraindicationsKnown prostate cancer or breast cancer (androgen therapy is contraindicated).

PrecautionsAndrogen-sensitive epilepsy, migraine, sleep apnea, polycythemia, and fluid overload should be considered when prescribing testosterone.

Older adults and puberty inductionUse lower starting doses for older men; caution with induction of puberty and avoid IM injections in men with bleeding disorders.

Fertility and athletic considerationsCounsel regarding potential impact on fertility; competitive athletes should be warned about disqualification risks with androgen use.

OpenPayer

Implantable Hormone Pellets

Coverage Criteria for Implantable Hormone Pellets

Procedure, HCPCS, and Diagnosis Codes

Provider Actions, Prior Authorization, and Documentation

Background and Rationale

Definitions and Key Terms