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Date Printed: June 28, 2017: 11:41 PM

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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

03-59000-15

Original Effective Date: 02/15/02

Reviewed: 04/27/17

Revised: 05/15/17

Subject: Tocolytic Therapy

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
           
Other References Updates    
           

DESCRIPTION:

Tocolysis is the suppression of preterm labor. General indications for tocolysis, include continued regular uterine contractions associated with cervical changes in a preterm mother (<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 mother 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 mother to a medical center better equipped to handle premature delivery and neonatal intensive care. Tocolytic agents include beta-sympathomimetics, such as ritodrine or terbutaline. Only ritodrine has received FDA approval for use as a tocolytic agent. Ritodrine is no longer available in the United States, and thus only off-label medications are available (e.g. calcium channel blockers, magnesium sulfate, prostaglandin inhibitors).

POSITION STATEMENT:

Acute tocolytic therapy with calcium channel blockers, magnesium sulfate, prostaglandin inhibitors, and parenteral terbutaline meets the definition of medical necessity for the induction of tocolysis in individuals with preterm labor (<37 weeks of gestational age).

Maintenance tocolytic therapy (beyond 48-72 hours) with any medication in the home setting is considered experimental or investigational.

There is insufficient evidence in the published peer-reviewed scientific literature to permit conclusions concerning the effect of terbutaline for maintenance tocolysis on health outcomes. Limited clinical evidence has not shown terbutaline to be an effective drug for maintenance tocolysis

BILLING/CODING INFORMATION:

HCPCS Coding

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 (investigational)

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products:

No National Coverage Determination (NCD) and/or Local Coverage Determination (LCD) were found at the time of the last guideline reviewed date.

DEFINITIONS:

No guideline specific definitions apply.

RELATED GUIDELINES:

None applicable.

OTHER:

None applicable.

REFERENCES:

  1. Agency for Healthcare Research and Quality National Guideline Clearinghouse Management of Preterm Labor. 05/03.
  2. American College of Obstetricians and Gyncologists (ACOG) Technical Bulletin-Preterm Labor # 206, 06/95.
  3. Berkman ND, Thorp JM, Lohr KN, Carey TS, Hartmann KE, Gavin NI, Hasselblad V, Idicula AE. Tocolytic Treatment for the Management of Preterm Labor: A Review of the Evidence. American Journal of Obstetric Gynecology. 2003 June; 188 (6): 1648-1659.
  4. Blue Cross Blue Shield Association Medical Policy Tocolysis with Intravenous or Subcutaneous Terbutaline 5.01.107, 10/15.
  5. Conde-Agudelo A, Romero R, Kusanovic JP. Nifedipine in the management of preterm labor: a systematic review and metaanalysis. American Journal of Obstetrics and Gynecology 2011; 304(2): 134. e1-20.
  6. Goldenberg RL. The Management of Preterm Labor. Obstetrics & Gynecology High-Risk Pregnancy Series: An Expert’s View. Obstetrics & Gyncology, 2002.
  7. Haas DM, Caldwell DM, Kirkpatrick P et al. Tocolytic therapy for preterm delivery: systematic review and network meta-analysis. BMJ 2012; 345:e6226.
  8. Lam F, Elliott J, Jones JS et al. Clinical issues surrounging the use of terbutaline sulfates for preterm labor. Obstetrics Gynecology Survey 1998; 53 (11 Suppl): S85-95.
  9. Lam F, Gill P. β-Agonist Tocolytic Therapy. Obstetrics and Gynecology Clinics of North America 2005; 32(3): 457-484.
  10. Morrison JC, Chauhan SP, Carroll CS et al. Continuous Subcutaneous Terbutaline Administration Prolongs Pregnancy After Recurrent Preterm Labor. American Journal of Obstetrics and Gynecology 2003 June; 1460-5; discussion 1465-1467.
  11. Nanda K, Cook LA, Gallo MF, Grimes DA. Terbutaline pump maintenance therapy after threatened preterm labor for preventing preterm birth. The Cochran Database of Systematic Reviews 2002, Issue 4. Art. No.: CD003933. DOI: 10.1002/14651858.CD003933.
  12. Sanchez-Ramos L, Kaunitz AM, Gaudier FL et al. Efficacy of Maintenance Therapy After Acute Tocolysis: A Metaanalysis. American Journal of Obstetrics and Gynecology 1999; 181(2): 484-90.
  13. Sanchez-Ramos L, Kaunitz AM. Reassessing the value of maintenance tocolysis in preterm labor. Contemporary OB/GYN 2001; 7:45-66.
  14. Tan TC, Devendra K, Tan LK et al. Tocolytic treatment for the management of preterm labor: a systematic review. Singapore Medical Journal 2006; 47(5): 361-6.
  15. The American Academy of Pediatrics and American College of Obstetricians and Gynecologists Guidelines for Obstetric and Medical Complications, October 2002.
  16. The American College of Obstetricians and Gynecologists (ACOG) Management of Preterm Labor Practice Bulletin No. 43, May 2003.
  17. U. S. Food and Drug Administration Drug Safety Communication-Safety Announcement: New warnings against use of terbutaline to treat preterm labor (archived), 04/08/2016..
  18. Vogel JP, Nardin JM, Dowswell T et al. Combination of tocolytic agents for inhibiting preterm labour. Cochrane Database Systematic Review 2014; (7): CD006169.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 04/27/17.

GUIDELINE UPDATE INFORMATION:

02/15/02

New Medical Coverage Guideline.

10/01/02

Local codes removed.

05/15/03

Annual review.

06/15/04

Scheduled review, no revisions.

03/15/05

Scheduled review, no change in coverage statement. Updated references.

11/15/05

Deleted E0781. Added S9349.

03/15/06

Deleted paragraph from the description section regarding terbutaline. Deleted reference to “Matria” under when services are covered. Added S9349 to billing/coding information section, and updated references.

03/15/07

Scheduled review, no change in coverage statement, and updated references.

06/15/07

Reformatted guideline.

03/15/08

Scheduled review. Re-titled guideline, changed to “Maintenance Tocolytic Therapy (Intravenous or Subcutaneous)”. Revised position statement, deleted “oral” and statement regarding continuous infusion of terbutaline offered by carve out networks, and updated references.

03/15/09

Scheduled review. No change in position statement (experimental or investigational). Updated references.

03/15/10

Scheduled review. No change in position statement (experimental or investigational). Updated references.

05/11/14

Revision: Program Exceptions section updated.

11/01/15

Revision: ICD-9 Codes deleted.

05/15/17

Reviewed; MCG title revised; removed “maintenance” and “intravenous or subcutaneous”. Added acute tocolytic therapy. Revised maintenance tocolytic therapy. Revised S9349 code descriptor.Updated references.

Date Printed: June 28, 2017: 11:41 PM