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Tocolysis 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 of gestation. Successful delay of preterm delivery allows further fetal development and precludes potential 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 has been 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 and benefits. A 2012 guideline (reaffirmed 2014) 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 Ritodrine was voluntarily withdrawn from the U.S. market in 1998.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.
Acute 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 of 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.
Patient 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.
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Nervous/Mental Conditions, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of Medically Necessary, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
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.
08/26/2015: Medical policy revised to add ICD-10 codes. Removed ICD-9 procedure code 99.29 from the Code Reference section.
12/03/2015: Policy description updated. Policy statements unchanged. Policy guidelines updated to add medically necessary and investigative definitions.
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.