Mountain State Medical Policy Bulletin
Section: Injections
Number: I-17
Topic: Terbutaline Therapy (Subcutaneous) for Preterm Labor
Effective Date: October 20, 2008
Issued Date: May 24, 2010
Date Last Reviewed: 08/2009

General Policy Guidelines

Indications and Limitations of Coverage

Traditional options for management of patients experiencing preterm labor include: (1) long term intravenous tocolytic therapy in the hospital, and (2) the administration of oral tocolytics at home, usually ritodrine or terbutaline. However, some patients may either fail to respond to the medications given orally, or require the medication more frequently than every four hours. For these patients, physicians may prescribe tocolytic therapy to be delivered by a portable infusion pump for at-home use.

Tocolytic therapy (J3105), delivered subcutaneously by a portable infusion pump for at-home use in the management of preterm labor is experimental/investigational. This therapy does not have FDA approval and scientific evidence does not demonstrate that safety and efficacy have been proven. Therefore, it is not eligible for payment.

NOTE:
See Medical Policy Bulletin E-17 for guidelines on the portable external infusion pump.

NOTE:
This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Procedure Codes

J3105     

Traditional Guidelines

Refer to General Policy Guidelines

FEP Guidelines

Effective January 1, 2004, Tocolytic Therapy will be covered under Maternity Care Benefits. Tocolytic Therapy and related services are covered if administered through IV or subcutaneous infusion. The services must be provided and billed by a Home Infusion or Home Health Care provider and are subject to the visit maximum.

Note: Oral Tocolytic Therapy is not a covered service.

PPO Guidelines

Refer to General Policy Guidelines

Managed Care POS Guidelines

Refer to General Policy Guidelines

Publications

References

New Perspectives for the Effective Treatment of Preterm Labor, American Journal of Obstetrics & Gynecology, Vol. 173, No. 2, 08/1995

Prevention of Premature Birth, The New England Journal of Medicine, Vol. 339, No. 5, 07/1998

Terbutaline Pump Maintenance Therapy for Prevention of Preterm Delivery: A Double-Blind Trial, American Journal of Obstetrics & Gynecology, Vol. 179, No. 4, 10/1998

Efficacy of Maintenance Therapy After Acute Tocolysis: A Meta-analysis, American Journal of Obstetrics & Gynecology, Vol. 181, No. 2, 08/1999

The Control of Labor, The New England Journal of Medicine, Vol. 342, No. 9, 08/1999

Institute for Clinical Systems Improvement, ICSI Technology Assessment Report #49, 03/2000

Terbutaline Sulfate, USPDI-Vol. I, Edition 21, 2001, Micromedex, Inc.

American College of Obstetricians and Gynecologists: Management of Preterm Labor: ACOG Practice Bulletin, No. 43, Obstetrics Gynecology, 101, 1039-1047, 2003

Tocolytic Treatment for the Management of Preterm Labor: A Review of the Evidence, American Journal of Obstetrics & Gynecology, Vol. 188, No. 6, 06/2003

Management of Preterm Labor, National Guideline Clearinghouse, ACOG, Summary completed February 4, 2004, and verified by the guidelines developer on June 25, 2004

Practical Strategies: Prevention of Recurrent Preterm Birth, A Roundtable Discussion, Supplement to OBG Management, 01/2007

Prevention of Preterm Delivery, The New England Journal of Medicine, Vol. 357, No. 5, 08/2007

Terbutaline Sulfate for Preterm Labor (letter), FDA website, 11/13/1997, Available at http://www.fda.gov/medwatch/SAFETY/1997/terbut.htm. December 19, 2007

Nanda K, Cook L, Gallo M, Grimes D. Terbutaline pump maintenance therapy after threatened preterm labor for preventing preterm birth. Cochrane Database of Systematic Reviews. 2002;Issue 4. Re-reviewed April 27, 2007.

Management of Preterm Labor. Summary, Evidence Report/Technology Assessment: Number 18. AHRQ Publication No. 01-E020. Rockville, MD. Agency for Healthcare Research and Quality. October 2000. www.ahrq.gov/clinic/epcsums/pretermsum.htm. Accessed August 2, 2009.

ACOG Practice Bulletin: Premature Rupture of Membranes. Clinical management guidelines for obstetrician-gynecologists. International Journal of Gynecology & Obstetrics. Number 1. June 1998;63:75-84.

ACOG Practice Bulletin: Management of Preterm Labor.International Journal of Gynecology & Obstetrics. Number 43. May 2003;82:127-135.

Management of Preterm Labor. National Guidelines Clearinghouse. July 26, 2004. www.guideline.gov. Accessed August 11, 2009.

Elliott J. Preterm Labor in Twins and High-Order Multiples. In: Clinics in Perinatology. W. B. Saunders Co;2007.

Jones J, Morrison J, Istwan N, et. al. The interval to spontaneous delivery following discontinuation of maintenance tocolysis. Journal of Maternal-Fetal & Neonatal Medicine. June 2006;19(6).

Gabbe. Obstetrics: Normal and Problem Pregnancies. 5th ed. Churchill Livingstone;2007.

View Previous Versions

[Version 006 of I-17]
[Version 005 of I-17]
[Version 004 of I-17]
[Version 003 of I-17]
[Version 002 of I-17]
[Version 001 of I-17]

Table Attachment

Text Attachment

Procedure Code Attachments

Diagnosis Codes

Non-covered Diagnosis Codes

644.00644.03  

Glossary




This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Medical policies are designed to supplement the terms of a member's contract. The member's contract defines the benefits available; therefore, medical policies should not be construed as overriding specific contract language. In the event of conflict, the contract shall govern.

Medical policies do not constitute medical advice, nor the practice of medicine. Rather, such policies are intended only to establish general guidelines for coverage and reimbursement under Mountain State Blue Cross Blue Shield plans. Application of a medical policy to determine coverage in an individual instance is not intended and shall not be construed to supercede the professional judgment of a treating provider. In all situations, the treating provider must use his/her professional judgment to provide care he/she believes to be in the best interest of the patient, and the provider and patient remain responsible for all treatment decisions.

Mountain State Blue Cross Blue Shield (MSBCBS) retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of MSBCBS. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.