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.

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.

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.

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