CurrentAetnaPolicy 0468

Magnesium Sulfate Injections and Terbutaline Pump for Preterm Labor

Defines Aetna's medical necessity and investigational positions on magnesium sulfate injections for short-term prolongation of pregnancy and on outpatient/subcutaneous terbutaline pump therapy for prevention or treatment of preterm labor; intended for clinicians and billing staff managing preterm labor.

Policy Summary

PayerAetna

PolicyMagnesium Sulfate Injections and Terbutaline Pump for Preterm Labor

Policy CodePolicy 0468

Change TypeNo material clinical or coverage changes

Effective DateApr 13, 2001

Next Review DateMay 9, 2024

Key ActionVerify plan-specific prior authorization and include appropriate ICD-10 diagnosis codes (O60.02-O60.03) and applicable drug and pump codes when submitting claims.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≤48hshort-term coverage window

experimentalterbutaline pump status

O60.02-O60.03relevant ICD-10

J3475,J3105included J-codes

<32wneuroprotection GA

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Coverage Criteria

inv-01: Magnesium sulfate — medically necessary use

Covered when ALL of the following are met

Magnesium sulfate for short-term prolongation: Magnesium sulfate injections are medically necessary for short-term prolongation of pregnancy (up to 48 hours) in pregnant women who are at risk of preterm delivery within 7 days.up to 48 hours; risk of delivery within 7 days

Supports antenatal neuroprotection for infants at risk of preterm delivery; evidence from meta-analysis and trials shows reduction in moderate-to-severe cerebral palsy.

inv-02: Terbutaline pump — experimental and investigational

Not covered / investigational

Terbutaline pump for prevention or treatment: The use of a terbutaline pump for administration of subcutaneous terbutaline is considered experimental and investigational for the prevention or treatment of premature labor because effectiveness has not been established and safety concerns exist.prolonged/outpatient maintenance use

FDA and systematic reviews advise against prolonged outpatient use beyond 48–72 hours due to serious maternal risks and lack of neonatal benefit; RCTs and reviews found no reduction in adverse neonatal outcomes and high cost.

inv-03: Medically necessary indications

Covered when supported by guideline-recommended indications and durations

Fetal neuroprotection: Magnesium sulfate for fetal neuroprotection is supported before anticipated early preterm delivery (less than 32 weeks of gestation)gestational age <32 weeks

Per ACOG/SMFM Committee Opinion; evidence shows reduced risk of moderate-to-severe cerebral palsy.

Preeclampsia/eclampsia seizures: Magnesium sulfate is indicated for prevention and treatment of seizures in women with preeclampsia or eclampsiaclinical diagnosis of preeclampsia/eclampsia

Per ACOG/SMFM Committee Opinion

Short-term tocolysis adjunct: Short-term (usually <48 hours) use to prolong pregnancy to allow administration of antenatal corticosteroids in women at risk of preterm delivery within 7 days

The use of terbutaline administered via a subcutaneous infusion pump for outpatient or home maintenance tocolysis is not supported. Terbutaline should not be used in the outpatient or home setting, and prolonged use to prevent recurrent preterm labor is contraindicated because of reports of serious maternal cardiac events and death. The FDA has advised against prolonged terbutaline treatment beyond 48 to 72 hours for prevention or prolonged treatment of preterm labor and requires boxed warnings and contraindications on terbutaline labeling for these uses.

This Clinical Policy Bulletin provides a summary of Aetna's coverage positions and is not a substitute for the terms of an individual member’s insurance contract. Specific plan benefits, limitations, exclusions and prior authorization requirements are determined by the member’s plan documents and contract language.

Terbutaline pump maintenance therapy has not demonstrated reductions in adverse neonatal outcomes in randomized trials and systematic review evidence. Trials included in the Cochrane review found no clear benefit of pump therapy over placebo or oral therapy and reported substantially higher costs; safety data are limited. Consequently, terbutaline pump maintenance therapy is considered an unsupported and high-cost intervention outside of well‑conducted randomized controlled trials.

Evidence assessing terbutaline pump maintenance therapy includes systematic reviews and technology assessments that found limited, low‑quality trial data and concerns about safety. A Cochrane review (Chawanpaiboon et al., 2014) found no evidence of benefit on neonatal outcomes and noted high cost and limited safety information. An AHRQ‑commissioned assessment and other reviews similarly reported low confidence in the evidence base and post‑marketing reports of serious maternal harms. The FDA issued warnings and required boxed labeling advising against prolonged use (> 48–72 hours) and against outpatient use of injectable terbutaline for preterm labor.

Coding

Listed CPT/HCPCS/J/ICD-10 codesmixed

99601	Home infusion/specialty drug administration, per visit (up to 2 hours)
99602	each additional hour (List separately in addition to code for primary procedure)
E0779	Ambulatory infusion pump, mechanical, reusable, for infusion 8 hours or greater
E0780	Ambulatory infusion pump, mechanical, reusable, for infusion less than 8 hours
E0781	Ambulatory infusion pump, single or multiple channels, electric or battery operated, with administrative equipment, worn by patient
J3105	Injection, terbutaline sulfate, up to 1 mg
J3475	Injection, magnesium sulfate, per 500 mg
S9208	Home management of preterm labor, including administrative services, professional pharmacy services, care coordination, and all necessary supplies or equipment (drugs and nursing visits coded separately), per diem (do not use this code with any home infusion per diem code)
S9349	Home infusion therapy, tocolytic infusion therapy; administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment (drugs and nursing visits coded separately), per diem
O60.02 - O60.03	Preterm labor without delivery [after 22 weeks but before 37 weeks]

inv-09: Duration limits for terbutaline use

Maximum recommended durationTerbutaline prolonged use beyond 48–72 hours is not supported and is associated with safety concerns (FDA warning).

Outpatient/home useInjectable terbutaline should not be used in pregnant women for prevention or prolonged treatment (beyond 48–72 hours) in either the hospital or outpatient setting (FDA boxed warning).

EffectivenessThe terbutaline pump has not been shown to prolong gestation or improve neonatal outcomes; largest RCTs found no significant benefit.

Safety concernsSerious maternal risks reported with prolonged subcutaneous terbutaline include chest pain, tachycardia, dyspnea, pulmonary edema, and death.

Provider Actions & Billing

Prior Authorization

Authorization for infusion and pump-related codes

Prior authorization may be required for infusion services and infusion pump rental/loaner codes depending on plan benefits. Verify plan-specific prior authorization requirements before initiating home infusion or supplying an ambulatory infusion pump.

Affected codes may include HCPCS E0779, E0780, E0781 and infusion administration codes 99601, 99602
J-codes J3105 (terbutaline sulfate) and J3475 (magnesium sulfate) — coverage depends on medical necessity and plan rules

Note

Check plan-specific prior authorization

Check member’s plan benefits and prior authorization rules for coverage of tocolytic therapy, home infusion, and durable medical equipment. Absence of a coverage benefit or lack of prior authorization may result in claim denials.

Confirm benefit for home infusion per diems S9208 / S9349 if billed
Confirm whether terbutaline pump or terbutaline J-code is considered noncovered or investigational under the member’s specific plan

Background

Tocolytic agents, including terbutaline and magnesium sulfate, can delay delivery for approximately 24 to 48 hours, which may provide time for interventions such as antenatal corticosteroid administration. However, trials and reviews have not shown that tocolytics reduce rates of preterm birth or improve long‑term neonatal outcomes. Magnesium sulfate has a distinct role when used for antenatal fetal neuroprotection in mothers at risk of delivery 32 weeks gestation, whereas terbutaline maintenance therapy lacks demonstrated neonatal benefit and is associated with maternal safety concerns, particularly with prolonged or outpatient use.

Definitions

inv-19: Short-term prolongation definition

DefinitionAdministration of magnesium sulfate to prolong pregnancy for up to 48 hours to allow interventions such as antenatal corticosteroid administration in women at risk of preterm delivery within 7 days.

Typical windowUp to 48 hours (short-term) as described by ACOG/SMFM Committee Opinion.

Indication contextUsed to permit time for corticosteroid administration in women at risk of delivery within 7 days.

inv-20: Terbutaline pump (subcutaneous maintenance tocolysis) definition

DefinitionUse of a subcutaneous infusion pump to deliver terbutaline for maintenance prevention or treatment of recurrent preterm labor; requires a pump for subcutaneous administration.

Coverage stanceConsidered experimental and investigational for prevention or treatment of premature labor because effectiveness has not been established.