Aetna Progestins Coverage & PA Policy Update | OpenPayer

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Aetna Progestins Coverage & PA Policy Update | OpenPayer

Coverage Criteria for Progestins

Etonogestrel Subdermal Implant

Covered when ALL of the following are met:

Etonogestrel implant coverage: Etonogestrel subdermal implant (Nexplanon) is medically necessary for the prevention of pregnancy.

Many plans exclude contraceptives; check benefit plan descriptions.

Medroxyprogesterone Acetate Injection

Covered when ALL of the following are met:

Depo‑Provera 150 mg/mL: Depo‑Provera CI or generic formulation 150 mg/mL is medically necessary for prevention of pregnancy.150 mg every 3 months

Coverage contingent on member plan including contraceptive drugs/devices; many plans exclude contraceptives—check benefit plan descriptions.

Depo‑Provera 400 mg/mL (oncologic use): Depo‑Provera 400 mg/mL is medically necessary as adjunctive/palliative therapy for inoperable, recurrent, or metastatic endometrial or renal carcinoma.initial doses 400–1000 mg per week; may be maintained at 400 mg per month if stabilized

Formulation 400 mg/mL was discontinued Oct 27, 2020.

Progesterone Injection

Covered when ALL of the following are met:

Progesterone IM for amenorrhea/abnormal bleeding: Progesterone intramuscular injection is medically necessary for treatment of amenorrhea or abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology.Amenorrhea: 5–10 mg for 6–8 days; Abnormal bleeding: 5–10 mg daily for 6 doses

Refer to pharmacy benefit for intravaginal/oral formulations; intramuscular route indicated as specified.

Progestin‑Releasing Intrauterine Devices

Covered when ALL of the following are met:

Progestin IUDs for contraception or heavy menstrual bleeding: Progestin-releasing intrauterine devices (e.g., Kyleena, Mirena, Skyla, Liletta) are medically necessary for contraception or for treatment of heavy menstrual bleeding.Device-specific durations apply (e.g., Mirena up to 5 years; Skyla/Liletta up to 3 years)

Many plans exclude contraceptives; check benefit plan descriptions. Evidence supports LNG-IUS as an alternative to endometrial ablation up to 2 years.

Hydroxyprogesterone Caproate (Makena)

Covered when ALL of the following are met:

Makena for recurrent preterm birth prevention: Hydroxyprogesterone caproate (Makena) is indicated to reduce the risk of preterm birth in women with a singleton pregnancy and a documented prior singleton spontaneous preterm birth.Weekly IM dosing (commonly 250 mg) beginning in the second trimester (approximately 16–20 weeks) and continuing until 36 weeks as per trials/guidelines.

Efficacy demonstrated only in women with prior spontaneous singleton preterm birth; not intended for multiple gestations.

Investigational / Not Medically Necessary

Not covered/considered investigational for the following uses:

Etonogestrel other indications: Etonogestrel subdermal implant is experimental and investigational for all indications other than prevention of pregnancy.

Medroxyprogesterone other indications: Intramuscular medroxyprogesterone acetate is experimental and investigational for all indications other than those specifically listed (e.g., contraception; specified oncologic palliative uses).

Oral formulations fall under pharmacy benefit.

Progesterone other indications: Progesterone intramuscular injection is experimental and investigational for other indications including prevention of pregnancy, reduction of neonatal morbidity/prolongation of pregnancy in twin pregnancies, treatment of endometrial hyperplasia, premenstrual syndrome, and stroke.

Progesterone subcutaneous injection is experimental for moderate-to-severe COVID-19.

Prevention of recurrent spontaneous preterm birth

Covered when ALL of the following are met (guideline-supported use):

Recurrent SPTB prevention (singleton) - eligibility: Pregnancy is a singleton gestation AND there is documentation of a prior spontaneous singleton preterm birth (delivery between 20 and 36 6/7 weeks).Initiate progesterone supplementation at 16–24 weeks and continue through 36 weeks.

ACOG/SMFM recommend offering progesterone in this population; evidence from trials (e.g., Meis et al) supports reduction in recurrent PTB.

Formulation options: Treatment may be with intramuscular 17‑OHPC (commonly 250 mg weekly) OR vaginal progesterone (e.g., 90‑mg gel or 100–200 mg suppository daily).

Recent evidence and guidelines note vaginal progesterone as a reasonable alternative to 17‑OHPC.

Scenarios without demonstrated benefit

Not covered / not recommended when ANY of the following apply:

Multiple gestation: Pregnancy is a twin or higher-order multiple gestation; trials did not show reduction in preterm birth or neonatal morbidity and guidelines do not recommend routine progesterone supplementation for multiple gestations.

Randomized trials (e.g., Rouse; Lim) demonstrated no benefit in multiples.

PPROM or preterm labor: Current pregnancy complicated by preterm premature rupture of membranes (PPROM) or arrested preterm labor; insufficient evidence that progesterone supplementation is beneficial in these settings.

Guidelines state routine supplementation is not useful for PPROM or after arrested preterm labor.

Vaginal progesterone for short cervix

Covered when ALL of the following are met

Eligibility: Asymptomatic singleton pregnancy with sonographic short cervix identified in mid‑trimester (examples used in trials: cervical length ≤15–20 mm) at approximately 19–24 weeks gestation.Cervical length thresholds cited in trials include ≤15 mm or ≤20 mm (study-specific).

Randomized trials (Hassan; Fonseca) demonstrated reduced preterm birth before 33–34 weeks and improved neonatal outcomes with vaginal progesterone; ACOG considers offering progesterone for very short cervix.

Twin pregnancy

Not supported / Not covered when evidence shows no benefit

Twin gestation: Use of progesterone (including vaginal progesterone) to prevent early preterm birth in unselected twin pregnancies is not supported by evidence and is not considered medically necessary.N/A

Meta-analyses and randomized trials in twin gestations did not show benefit.

Medroxyprogesterone acetate (Depo‑Provera CI)

Covered when ALL of the following are met

Contraceptive indication: Medroxyprogesterone acetate injectable contraception (Depo‑Provera CI) is medically necessary when used by females of reproductive potential to prevent pregnancy.Standard contraceptive dosing: 150 mg IM every 3 months.

Coverage applies only if the member's benefit plan covers contraceptive drugs/devices; many plans exclude contraceptives—verify benefits.

Duration caution: Avoid long‑term use beyond 2 years unless other birth control methods are inadequate.>2 years

Label includes black box warning for loss of bone mineral density with prolonged use.

Gender dysphoria (off‑label)

Consider when ALL of the following apply

When GnRH analogues unavailable or contraindicated: Progestins (e.g., medroxyprogesterone) may be used for puberty suppression or menstrual suppression in transgender adolescents when GnRH analogues are unavailable or contraindicated.N/A

Guidelines state GnRH analogues are preferred; document reason for choosing progestin as alternative.

Progesterone for prevention of preterm birth

Covered when ALL of the following trial-supported conditions are met

Eligibility: Asymptomatic pregnant woman with a sonographic short cervix (trial examples: cervical length ≤15 mm or <25 mm) or a singleton pregnancy with prior spontaneous preterm birth.Cervical length thresholds cited: <=15 mm or <25 mm depending on study.

Randomized trials and guideline recommendations support progesterone supplementation (vaginal or intramuscular 17‑OHPC 250 mg weekly) initiated in mid‑trimester and continued to 36 weeks to reduce recurrent spontaneous preterm birth in eligible women.

Levonorgestrel-releasing IUD for contraception and heavy menstrual bleeding

Covered when device is used for FDA-approved contraception or for management of heavy menstrual bleeding when medically indicated

IUD use: Levonorgestrel-releasing intrauterine system (LNG‑IUS; e.g., Mirena, Kyleena, Liletta, Skyla) is medically necessary for FDA‑approved contraception and for reduction of menstrual blood loss when clinically indicated.Device-specific approved durations apply (e.g., Skyla/Liletta up to 3 years; Mirena/Kyleena up to 5 years).

Cochrane and RCT evidence support LNG‑IUS efficacy for heavy menstrual bleeding and as an alternative to endometrial ablation up to 2 years; evidence for fibroid treatment is limited.

Coverage of contraceptive products described in this policy (for example, etonogestrel subdermal implant, progestin-releasing IUDs, and medroxyprogesterone acetate injectable contraception) may be dependent on the member’s benefit plan. Many plans exclude coverage of contraceptives; confirm the member’s benefit plan description before assuming coverage or submitting authorization requests.

Certain diagnosis codes are referenced in the policy as examples of covered or excluded indications. Examples of ICD-10 codes appearing in the CPT/ICD/HCPCS section include codes for excessive or irregular uterine bleeding (e.g., N92.0), and codes specifically noted as not covered for some listed indications such as endometrial hyperplasia (N85.00–N85.02) and twin pregnancy (O30.001–O30.099). Verify the precise ICD-10 code linkage required by the plan when requesting coverage.

The FDA withdrew approval of Makena (hydroxyprogesterone caproate) effective April 6, 2023; as a result, Makena and generics for the approved indication can no longer be lawfully distributed in interstate commerce. The withdrawal followed a post‑approval confirmatory trial that did not verify clinical benefit, and this regulatory action affects availability and prior‑authorization pathways for that branded product.

Medroxyprogesterone acetate injection (Depo‑Provera CI) carries important contraindications and safety precautions. It is contraindicated in known or suspected pregnancy, active thrombophlebitis or history of thromboembolic disorders, current or past breast malignancy, significant liver disease, hypersensitivity to the product, and undiagnosed vaginal bleeding. The label also includes a boxed warning about loss of bone mineral density with increasing duration of use and recommends avoiding long‑term use beyond 2 years unless other methods are inadequate.

Injectable progesterone preparations are FDA‑approved for treatment of amenorrhea and abnormal uterine bleeding due to hormonal imbalance, but are not indicated for prevention of pregnancy. The policy identifies progesterone intramuscular injection as experimental and investigational for uses including prevention of pregnancy and prolongation of pregnancy in twin gestations.

Use of progestational agents as tocolytics for treatment of threatened or established preterm labor is not supported by robust evidence. A Cochrane review and small trials found limited and inconsistent data, and the policy states there is insufficient evidence to advocate routine use of progestational agents as tocolytics.

Evidence is insufficient to support use of progestogen‑releasing intrauterine systems or oral progestogens to reduce uterine fibroid size or as established therapy for uterine fibroids. Available randomized data are limited and small, and the policy concludes that this indication is not supported by adequate evidence.

Portions of the document consist of administrative content, references, and policy history without explicit clinical exclusion statements. These administrative excerpts do not by themselves define clinical coverage decisions; always refer to the coverage criteria sections for clinical exclusion or investigational determinations.

The policy specifically lists multiple indications for which progesterone injections are not supported (for example, prevention of pregnancy and reduction of neonatal morbidity in twin pregnancies). Randomized trials and meta-analyses in twin gestations did not demonstrate benefit, and the policy therefore does not support use of injectable progesterone for these indications.

Multiple randomized trials in women with multiple gestations (twins or higher-order multiples) failed to show that 17‑OHPC reduces preterm birth or improves neonatal outcomes. The policy summarizes this evidence and states that use of 17‑OHPC (including Makena) for multiple gestations is not supported by trial evidence and therefore not recommended for that indication.

Vaginal progesterone given to unselected twin pregnancies has not been shown to prevent early preterm birth in randomized trials and meta-analyses. The policy references these negative trials and concludes that routine use of vaginal progesterone for unselected twin gestations is not supported.

Progesterone administered as a tocolytic for women presenting with preterm labor is not established as effective. Systematic review data and small trials provide insufficient evidence of benefit, and the policy indicates such use would be considered not medically necessary or non‑covered.

Within the provided excerpts there are no standalone explicit statements labeled as 'not medically necessary' outside the organized criteria sections; the policy uses criteria sets and investigational lists to indicate non‑covered or experimental uses rather than isolated declarative lines in administrative text.

Codes, Dosing, and Device Approvals

Prior Authorization

Prior Authorization and Makena Regulatory Status

Prior authorization impacted by Makena's regulatory status: Makena (17‑alpha‑hydroxyprogesterone caproate) regulatory actions may affect prior authorization (PA) requirements for hydroxyprogesterone products. Providers should confirm PA policies at time of service because FDA approvals, withdrawals, or availability of commercial product versus compounded formulations can change coverage and PA handling.

Confirm PA requirements for hydroxyprogesterone (Makena) and compounded 17P at time of service; regulatory status may change PA handling.

Prior Authorization

Prior Authorization Not Specified in These Chunks

No single universal prior authorization instruction is specified exclusively in these coding chunks. Some HCPCS/CPT codes listed may be subject to payer-specific PA — check the payer's medical policy and billing guidance.

PA not specified in this section for all listed codes; verify with Aetna prior authorization tools.

Provider Actions, Documentation, and Authorization

Prior Authorization

Makena FDA withdrawal may affect PA and availability

FDA withdrawal of approval for Makena (hydroxyprogesterone caproate) (effective April 6, 2023) affects lawful distribution and may impact prior authorization or coverage for that branded product; consider documentation of alternatives such as compounded 17‑OHPC or vaginal progesterone when applicable.

Document if a compounded 17‑OHPC or vaginal progesterone is being used as an alternative and provide supporting rationale.
Confirm availability and PA requirements for alternative formulations with benefit plan/medical policy.

Prior Authorization

Verify contraceptive benefit coverage for Depo‑Provera

When medroxyprogesterone acetate (Depo‑Provera) is requested for contraception, confirm that the member’s benefit plan covers contraceptive drugs/devices because coverage is only provided under plans that specifically include contraceptive benefits.

If the plan excludes contraceptives, anticipate denial and advise the member accordingly.
Include contraceptive indication and relevant Z30.* encounter codes when submitting requests.

Background and Evidence Summary

Background: Etonogestrel subdermal implants (e.g., Nexplanon) are single‑rod, long‑acting reversible contraceptives placed subdermally in the upper arm. They act primarily by suppressing ovulation and altering cervical mucus and the endometrium, and are approved for contraception for up to 3 years.

Definitions and Product Summaries

Nexplanon — product definition and key attributes

ProductNexplanon (etonogestrel subdermal implant)

DescriptionSingle‑rod subdermal progestin implant placed in the inner side of the upper arm for contraception

Duration of effectivenessEffective for up to 3 years; must be removed by end of year three

Key contraindications/warningsContraindicated in known or suspected pregnancy, breast cancer, active liver disease, undiagnosed abnormal genital bleeding; insertion/removal risks include migration and vascular complications

Makena (hydroxyprogesterone caproate / 17P) — definition and indicated use

ProductMakena (hydroxyprogesterone caproate; 17‑OHPC)

Policy Revision History and Changes

April 6, 2023FDA withdrawalLatest

FDA withdrew approval of Makena (hydroxyprogesterone caproate) and its generics after a postapproval confirmatory trial failed to verify clinical benefit; approvals withdrawn effective immediately and the products can no longer be lawfully distributed in interstate commerce for the approved indication.

October 2020CDER proposed withdrawal (administrative record)

FDA’s Center for Drug Evaluation and Research (CDER) proposed withdrawal of Makena approval after the postapproval trial results raised concerns; the sponsor requested a hearing before final determination.

Policy administrative dates: Effective: 08/03/2001; Last Review: 08/30/2023; Next Review: 04/25/2024. These dates reflect the policy history as shown in the document.