Aetna Implantable Hormone Pellets coverage criteria

What this means for the claim

The covered path, the next step to get it approved, and the specific way it denies — built only from this policy.

Coverage criteria

• Testosterone propionate implant pellets (Testopel) — Criteria for Initial Approval: considered medically necessary for ANY ONE of the following indications (indications 1-3 below).
• Initial approval indication: Delayed male puberty.
• Initial approval indication: Gender dysphoria, when ALL of the following are met: (a) the member has a diagnosis of gender dysphoria; AND (b) the member is able to make an informed decision to engage in hormone therapy; AND (c) the member's comorbid conditions are reasonably controlled; AND (d) the member has been educated on any contraindications and side effects to therapy; AND (e) before the start of therapy, the member has been informed of fertility preservation options; AND (f) for members less than 18 years of age, this medication will be prescribed by or in consultation with a provider specialized in the care of transgender youth (e.g., pediatric endocrinologist, family or internal medicine physician, obstetrician-gynecologist) that has collaborated care with a mental health care provider, AND the member has reached, or has previously reached, Tanner stage 2 of puberty or greater.
• Initial approval indication: Primary or hypogonadotropic hypogonadism, when the following is met: before the start of testosterone therapy, the member has at least TWO confirmed low morning testosterone levels based on the reference laboratory range or current practice guidelines.
• Testosterone propionate implant pellets (Testopel) — Continuation of Therapy: considered medically necessary for ANY ONE of the following indications (continuation indications below).
• Continuation of therapy for delayed puberty OR gender dysphoria: ALL members (including new members) requesting authorization for continuation of therapy must meet ALL requirements in the Criteria for Initial Approval section.
• Continuation of therapy for primary or hypogonadotropic hypogonadism: before the start of testosterone therapy, the member had a (ONE) confirmed low morning testosterone level based on the reference laboratory range or current practice guidelines.

Covered codes

Codes listed in this Aetna policy. Check each one's prior-authorization verdict and Medicare rate:

• 11980·PA verdict·Rate
• 20700·PA verdict·Rate
• J1073·PA verdict·Rate

Documentation required

• Androgen deficiency is indicated by either 2 consecutive low total (free plus protein-bound) fasting serum testosterone levels (below the testing laboratory's normal reference range or below 300 ng/dL), or — for persons with low normal total fasting serum testosterone levels (above 300 ng/dL but below 400 ng/dL) — 2 consecutive low free or bioavailable fasting serum testosterone levels (below the testing laboratory's normal reference range, or less than 225 pmol/L (6 ng/dL) if reference ranges are not available).
• Two consecutive fasting total serum testosterone levels are required to determine medical necessity of testosterone replacement, OR 2 consecutive free or bioavailable fasting serum testosterone levels if total testosterone is in the low normal range.
• Two morning samples drawn between 7:00 a.m. and 10:00 a.m. obtained on different days are required.
• For initial approval of primary or hypogonadotropic hypogonadism: at least two confirmed low morning testosterone levels (based on reference laboratory range or current practice guidelines) before the start of testosterone therapy; for continuation, at least one confirmed low morning testosterone level before the start of therapy.
• Documentation of low serum testosterone is NOT required for bilateral orchiectomy.

Frequently asked questions

When does Aetna cover Implantable Hormone Pellets (CPT 11980), and what gets it denied?

Aetna CPB 0345 covers implantable testosterone propionate pellets (Testopel) as medically necessary for delayed male puberty, gender dysphoria (when a full set of informed-consent, comorbidity, fertility-counseling, and — for minors — specialist-prescribing and Tanner stage 2+ criteria are met), or primary/hypogonadotropic hypogonadism documented by confirmed low morning testosterone levels (two for initial approval, one for continuation). Implantable estradiol pellets, progestin/progesterone pellets (for dysmenorrhea or erythema nodosum), and testosterone pellets for aging-related/idiopathic hypogonadism, male menopause, women's pain management, cancer treatment, or menopausal symptoms are considered experimental, investigational, or unproven. The bulletin is silent on whether precertification/prior authorization is required. Coverage criteria include: Testosterone propionate implant pellets (Testopel) — Criteria for Initial Approval: considered medically necessary for ANY ONE of the following indications (indications 1-3 below).; Initial approval indication: Delayed male puberty.; Initial approval indication: Gender dysphoria, when ALL of the following are met: (a) the member has a diagnosis of gender dysphoria; AND (b) the member is able to make an informed decision to engage in hormone therapy; AND (c) the member's comorbid conditions are reasonably controlled; AND (d) the member has been educated on any contraindications and side effects to therapy; AND (e) before the start of therapy, the member has been informed of fertility preservation options; AND (f) for members less than 18 years of age, this medication will be prescribed by or in consultation with a provider specialized in the care of transgender youth (e.g., pediatric endocrinologist, family or internal medicine physician, obstetrician-gynecologist) that has collaborated care with a mental health care provider, AND the member has reached, or has previously reached, Tanner stage 2 of puberty or greater.; Initial approval indication: Primary or hypogonadotropic hypogonadism, when the following is met: before the start of testosterone therapy, the member has at least TWO confirmed low morning testosterone levels based on the reference laboratory range or current practice guidelines.; Testosterone propionate implant pellets (Testopel) — Continuation of Therapy: considered medically necessary for ANY ONE of the following indications (continuation indications below).; Continuation of therapy for delayed puberty OR gender dysphoria: ALL members (including new members) requesting authorization for continuation of therapy must meet ALL requirements in the Criteria for Initial Approval section.; Continuation of therapy for primary or hypogonadotropic hypogonadism: before the start of testosterone therapy, the member had a (ONE) confirmed low morning testosterone level based on the reference laboratory range or current practice guidelines.. Applies to 3 codes: 11980, 20700, J1073. Confirm prior-authorization status with Aetna before scheduling — it is code- and plan-specific, and this policy is not an exact authorization source. Documentation: Androgen deficiency is indicated by either 2 consecutive low total (free plus protein-bound) fasting serum testosterone levels (below the testing laboratory's normal reference range or below 300 ng/dL), or — for persons with low normal total fasting serum testosterone levels (above 300 ng/dL but below 400 ng/dL) — 2 consecutive low free or bioavailable fasting serum testosterone levels (below the testing laboratory's normal reference range, or less than 225 pmol/L (6 ng/dL) if reference ranges are not available).; Two consecutive fasting total serum testosterone levels are required to determine medical necessity of testosterone replacement, OR 2 consecutive free or bioavailable fasting serum testosterone levels if total testosterone is in the low normal range.; Two morning samples drawn between 7:00 a.m. and 10:00 a.m. obtained on different days are required.; For initial approval of primary or hypogonadotropic hypogonadism: at least two confirmed low morning testosterone levels (based on reference laboratory range or current practice guidelines) before the start of testosterone therapy; for continuation, at least one confirmed low morning testosterone level before the start of therapy.; Documentation of low serum testosterone is NOT required for bilateral orchiectomy. Policy exclusions and limitations: Aetna considers implantable estradiol pellets experimental, investigational, or unproven because they have been shown to produce unpredictable and fluctuating serum concentrations of estrogen.; Implantable testosterone pellets are experimental, investigational, or unproven for hypogonadism due to aging (also known as 'age-related hypogonadism' or 'late-onset hypogonadism') because effectiveness for indications other than those listed as medically necessary has not been established.; Implantable testosterone pellets are experimental, investigational, or unproven for idiopathic hypogonadism (not due to disorders of the testicles, pituitary gland or brain) because effectiveness has not been established.; Implantable testosterone pellets are experimental, investigational, or unproven for male menopause because effectiveness has not been established.; Implantable testosterone pellets are experimental, investigational, or unproven for pain management in women because effectiveness has not been established.; Implantable testosterone pellets are experimental, investigational, or unproven for treatment of cancers (e.g., breast, kidney, and prostate) because effectiveness has not been established.; Implantable testosterone pellets are experimental, investigational, or unproven for treatment of symptoms associated with menopause, as this use remains unlabeled and unsubstantiated.; Progestin/progesterone pellets are experimental, investigational, or unproven for the treatment of dysmenorrhea because their effectiveness for this indication has not been established.; Progestin/progesterone pellets are experimental, investigational, or unproven for the treatment of erythema nodosum because their effectiveness for this indication has not been established. Claims may be denied when the requested service falls under these.

Does Aetna require prior authorization for Implantable Hormone Pellets?

Confirm prior-authorization status with Aetna before scheduling — it is code- and plan-specific, and this policy is not an exact authorization source. Documentation: Androgen deficiency is indicated by either 2 consecutive low total (free plus protein-bound) fasting serum testosterone levels (below the testing laboratory's normal reference range or below 300 ng/dL), or — for persons with low normal total fasting serum testosterone levels (above 300 ng/dL but below 400 ng/dL) — 2 consecutive low free or bioavailable fasting serum testosterone levels (below the testing laboratory's normal reference range, or less than 225 pmol/L (6 ng/dL) if reference ranges are not available).; Two consecutive fasting total serum testosterone levels are required to determine medical necessity of testosterone replacement, OR 2 consecutive free or bioavailable fasting serum testosterone levels if total testosterone is in the low normal range.; Two morning samples drawn between 7:00 a.m. and 10:00 a.m. obtained on different days are required.; For initial approval of primary or hypogonadotropic hypogonadism: at least two confirmed low morning testosterone levels (based on reference laboratory range or current practice guidelines) before the start of testosterone therapy; for continuation, at least one confirmed low morning testosterone level before the start of therapy.; Documentation of low serum testosterone is NOT required for bilateral orchiectomy.

What does Aetna exclude for Implantable Hormone Pellets?

Policy exclusions and limitations: Aetna considers implantable estradiol pellets experimental, investigational, or unproven because they have been shown to produce unpredictable and fluctuating serum concentrations of estrogen.; Implantable testosterone pellets are experimental, investigational, or unproven for hypogonadism due to aging (also known as 'age-related hypogonadism' or 'late-onset hypogonadism') because effectiveness for indications other than those listed as medically necessary has not been established.; Implantable testosterone pellets are experimental, investigational, or unproven for idiopathic hypogonadism (not due to disorders of the testicles, pituitary gland or brain) because effectiveness has not been established.; Implantable testosterone pellets are experimental, investigational, or unproven for male menopause because effectiveness has not been established.; Implantable testosterone pellets are experimental, investigational, or unproven for pain management in women because effectiveness has not been established.; Implantable testosterone pellets are experimental, investigational, or unproven for treatment of cancers (e.g., breast, kidney, and prostate) because effectiveness has not been established.; Implantable testosterone pellets are experimental, investigational, or unproven for treatment of symptoms associated with menopause, as this use remains unlabeled and unsubstantiated.; Progestin/progesterone pellets are experimental, investigational, or unproven for the treatment of dysmenorrhea because their effectiveness for this indication has not been established.; Progestin/progesterone pellets are experimental, investigational, or unproven for the treatment of erythema nodosum because their effectiveness for this indication has not been established. Claims may be denied when the requested service falls under these.

Source

Related

• All Aetna coverage policies
• Aetna prior-authorization requirements — which codes need PA, by CPT