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DESCRIPTIONTocolysis refers to the suppression of preterm labor to delay delivery. A variety of medications are proposed as tocolytic agents; none of the currently available options are approved by the U.S. Food and Drug Administration (FDA) for this indication. The same medications can also be used as maintenance therapy following successful tocolysis.
General indications for tocolysis, or the suppression of preterm labor, include continued regular uterine contractions associated with cervical changes in a pregnant woman at less than 37 weeks’ gestation. Successful delay of preterm delivery allows further fetal development and precludes the complications of preterm delivery, especially neonatal respiratory distress syndrome. Even short-term delay of delivery is thought to be beneficial in that it allows treatment of the patient with corticosteroids, which has proved beneficial in ameliorating the effects of neonatal respiratory distress syndrome. In some cases, a short delay in delivery may also allow transport of the pregnant woman to a medical center better equipped to handle premature delivery and neonatal intensive care.
A variety of agents have been used for tocolysis. The only FDA-approved tocolytic drug is ritodrine, a beta-sympathomimetic. Ritodrine is no longer available in the United States and thus only off-label medications are available. Terbutaline sulfate, FDA-approved for several non-tocolytic indications, is also a beta-sympathomimetic. Terbutaline is available as an oral or intravenous medication and, more recently, has been administered by continuous subcutaneous infusion via a portable pump for maintenance tocolysis. Other tocolytic drugs include calcium channel blockers (e.g., nifedipine), magnesium sulfate, oxytocin receptor antagonists (e.g., atosiban), prostaglandin inhibitors (e.g., indomethacin), and nitrates (e.g., nitroglycerin).
Tocolytic agents have potential risks, as well as potential benefits. A 2012 guideline issued by the American College of Obstetricians and Gynecologists summarized the potential adverse effects of common classes of tocolytic agents:
Calcium Channel Blockers
Nonsteroidal Anti-inflammatory Drugs
* Greatest risk associated with use for longer than 48 hours.
Beta-Adrenergic Receptor Agonists
Ritodrine was approved by the FDA for use as a tocolytic agent. Ritodrine was voluntarily withdrawn from the U.S. market in 1998.
Terbutaline is FDA-approved for the prevention and treatment of bronchospasm in patients with asthma and reversible bronchospasm associated with bronchitis and emphysema. Like other tocolytic agents, its use in tocolysis is off-label. In response to a citizen petition in June, 2008, the FDA reviewed safety data on terbutaline sulfate. They issued a safety announcement on February 17, 2011. Based on animal studies, the FDA reclassified terbutaline from pregnancy risk category B to pregnancy risk category C. In addition, the FDA required a boxed warning stating that injectable terbutaline should not be used for prevention or prolonged (beyond 2-3 days) treatment of preterm labor, and oral terbutaline should not be used for acute or maintenance tocolysis. The labeling change is based on a review of post-marketing safety reports submitted to the FDA’s Adverse Event Reporting System (AERS) of maternal death and serious maternal cardiovascular events associated with use of terbutaline.
Also, see the related medical policy Progesterone Therapy as a Technique to Reduce Preterm Birth in High-Risk Pregnancies.
POLICYAcute tocolytic therapy with parenteral terbutaline, calcium channel blockers, magnesium sulfate, and prostaglandin inhibitors may be considered medically necessary for the induction of tocolysis in patients with preterm (< 37 weeks’ gestational age) labor.
Maintenance (beyond 48-72 hours) tocolytic therapy with any medication is considered investigational.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
POLICY GUIDELINESPatient selection criteria for induction of tocolysis include regular uterine contractions associated with cervical changes. Induction of tocolysis typically requires hospitalization to monitor for incipient delivery.
Investigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY8/1999: Approved by Medical Policy Advisory Committee (MPAC)
2/1/2002: Appeal statement deleted from Policy Exception section
2/11/2002: Investigational definition added
5/8/2002: Type of Service and Place of Service deleted
9/30/2004: Policy title "Tocolytic Therapy for Preterm Labor" renamed "Tocolysis with Intravenous or Subcutaneous Terbutaline," Sources updated
10/6/2004: Code Reference section updated, CPT code 90782, 90784 deleted, ICD-9 diagnosis code 644.00, 644.10, 644.13, 644.20 added, HCPCS S9349 added
2/21/2005: Policy reviewed, Description and Policy sections revised to be consistent with BCBSA policy # 5.01.07, non-covered table added, HCPCS S9349 moved to non-covered table
3/14/2006: Coding updated CPT4 2005 revisions added to policy.
9/18/2007: Policy reviewed, no changes
06/22/2010: Policy title changed from “Tocolysis with Intravenous or Subcutaneous Terbutaline” to “Acute and Maintenance Tocolysis” as the description and policy statements were broadened to include additional agents in addition to terbutatline. Use in acute tocolysis may be considered medically necessary; use as maintenance is considered investigational. FEP verbiage added to the Policy Exceptions section. Deleted outdated references from the Sources section. Added CPT codes 96372 and 96374; also added HCPCS J3475.
02/23/2011: Policy reviewed; no changes.
08/03/2011: Policy description updated. Replaced "betamimetics" with "parenteral terbutaline" in the first policy statement. Deleted "including but not limited to subcutaneous or intravenous terbutaline" from the investigational policy statement.
01/09/2013: Policy reviewed; no changes.
04/19/2013: Deleted ICD-9 codes 644.20 and 644.21 from the Code Reference section.
11/15/2013: Policy reviewed; no changes.
11/17/2014: Policy reviewed; description updated regarding potential adverse effects of common classes of tocolytic agents. Policy statements unchanged.
SOURCE(S)Blue Cross Blue Shield Association policy # 5.01.07
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.