Mountain State Medical Policy Bulletin |
Section: | Injections |
Number: | I-17 |
Topic: | Terbutaline Therapy (Subcutaneous) for Preterm Labor |
Effective Date: | August 1, 2005 |
Issued Date: | January 7, 2008 |
Date Last Reviewed: | 06/2007 |
Indications and Limitations of Coverage
Traditional options for management of patients experiencing preterm labor (644.0, 644.00, 644.03) 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.
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J3105 |
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. |
New Perspectives for the Effective Treatment of Preterm Labor, American Journal of ObstetricsĀ & 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 |
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