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Medical Policy | |
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Subject: Premature Labor Therapies | ||
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Policy #: DME.00010 | Current Effective Date: | 05/07/2007 |
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Status: Reviewed | Last Review Date: | 03/08/2007 |
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Description/Scope
This policy addresses therapies for premature labor such as uterine activity monitoring and tocolytic therapy in the home setting.
Policy Statement
Rationale
Overall, there is no consistent evidence that either HUAM or maintenance tocolytics improves pregnancy management or health outcomes. Although neither is indicated as a general practice, opinions of some specialists as well as the suggestion of benefit in a few smaller studies support that in unusual circumstances these technologies could potentially benefit patient management, when used in conjunction with standard high risk care. In assessing patient benefit, the clinical experience and judgment of practicing experts may be weighted more heavily given limited opportunities for the study of rare obstetrical conditions, including high order multiple births and unusual physiologic or anatomic factors. Randomized controlled trials have not consistently demonstrated that HUAM improves patient management or health outcomes. Findings are inconsistent regarding the effects of HUAM on the rates of pre-term labor, pre-term delivery, low birth weight, neonatal complications, neonatal intensive care admissions, and infant hospital length of stay. In terms of the effectiveness of HUAM once pre-term labor has occurred, no well-designed studies have shown additional benefit from HUAM in preventing pre-term births. In terms of the effectiveness of HUAM on patients at higher risk of pre-term labor but who have not yet experienced it, studies have varied widely in quality, objectives and control for nursing contact, and reflected inconsistent results. Results of the two largest and more scientifically valid studies (1292 and 2422 participants, with control for nursing contact and analysis of all study participants rather than only those participants experiencing pre-term labor or delivery) failed to demonstrate that HUAM plus nursing contact was superior to daily or weekly nursing contact alone with respect to rates of pre-term labor, pre-term delivery, low birth weight, neonatal complications, neonatal intensive care admissions, and infant hospital length of stay or in the early detection of pre-term labor. Regarding home maintenance tocolytic therapy, randomized controlled trials have also failed to demonstrate effectiveness in managing women who had recently experienced an episode of pre-term labor that was arrested in the hospital. Other meta-analyses have confirmed these conclusions demonstrating no benefit in terms of gestational age at birth, pregnancy prolongation, or birth weight. This is especially true in singleton gestations. Less clear is the benefit of maintenance tocolytics for women at high risk for premature labor and delivery. There is at present a paucity of well-designed randomized controlled trials as to whether the benefits outweigh the risks for home tocolysis for this subgroup. In May 2003, the American College of Obstetricians and Gynecologists (ACOG) released an update of its practice guideline, Management of Preterm Labor. The summary of recommendations included the following statement: “Neither maintenance treatment with tocolytic drugs nor repeated acute tocolysis improve perinatal outcome; neither should be taken as a general practice.” In addition, a number of other authoritative sources including the U.S. Preventive Services Task Force and the American Medical Association have also concluded that there is insufficient evidence to recommend HUAM.
The Medical Policy and Technology Assessment Committee have made medical necessity determinations for home uterine monitoring and tocolysis based on recognized, broad-based and longstanding acceptance of these treatment modalities in the organized medical community. (See also: Off-Label Drug Use Clinical Guideline).
Background/Overview
Premature labor can compromise the mother and fetus. Maternal-fetal evaluation, early identification of problems, intervention and ongoing care can contribute to an optimal birth outcome.
Previously, patients were often hospitalized for premature labor. Advances in premature labor treatment have allowed a decrease of inpatient days and continuation of care in the home setting. Standard care for the early detection of premature labor in higher risk women includes more frequent prenatal visits and/or clinical examination, intensive instruction regarding the signs and symptoms of premature labor and the practice of uterine self-palpation to detect “silent” contractions. The home uterine activity monitor (HUAM) is a device designed for use in the home setting as an adjunct to standard care in the detection of patterns of contractions suggestive of premature labor. In theory, contractions suggestive of premature labor that can be identified in advance of cervical dilation may enable or contribute to earlier diagnosis and response. Early response to premature labor is important given that acute tocolytic therapy has been demonstrated to be less effective as cervical dilation increases and generally ineffective beyond 3-4cm dilation.
The home uterine monitoring device consists of a tocodynamometer (worn as a belt around the abdomen), a data recorder, and a data transmitter. Home uterine activity monitoring is generally done for one hour twice a day and additionally if the patient is having symptoms of premature labor, or when monitored contraction activity is increased. The recorded data is transmitted over phone lines to a center where it is interpreted by a perinatal staff, who intervene based on physician orders. The patient's physician is notified if the symptoms and/or contraction activity is not resolved. The FDA has approved two HUAM devices: the Healthdyne System 37 Home Uterine Monitoring System™ (Matria Healthcare) and the Genesis Home Uterine Monitoring System™ (Carelink Corp.). Labeling guidance by the FDA for HUAM in March 2001 stipulated that the following statement regarding limitations of HUAM effectiveness be placed prominently following statements for indications of use:
Terbutaline is a beta mimetic, FDA approved for the treatment of asthma. According to the FDA, adequate data establishing the safety and effectiveness of terbutaline as a tocolytic agent have not been submitted. Based on the published literature, the demonstrated value of tocolytic therapy in general, is limited to an initial brief period of treatment, probably no more than 48-72 hours. No benefit from prolonged treatment has been documented. In addition, the safety of long-term subcutaneous administration of terbutaline sulfate, especially on an outpatient basis, has not been adequately addressed. Subcutaneous tocolytic therapy can be delivered by a small external infusion pump programmed to deliver terbutaline doses for treatment of increased uterine activity. The patient is taught how to operate the pump, reload with medication, and change the infusion site.
Definitions
Cervical incompetence: A condition in which the cervix begins to open (dilate) and thin (efface) before the pregnancy has reached term
Gestational age: Gestational age is the time, measured in weeks, from the first day of the last normal menstrual cycle to the current date of the pregnancy
Placenta: A structure found in the uterus from which a fetus receives its nutrients and oxygen and through which fetal waste products are eliminated throughout pregnancy
Premature labor: The onset of regular uterine contractions occurring between 20 and 37 weeks of pregnancy associated with cervical change (e.g. dilation greater than or equal to 2.0 cm., effacement exceeding 80%, changes in cervical dilation or effacement detected by serial examination or transvaginal cervical sonography of cervical length)
Preterm premature rupture of membranes (PPROM): Rupture of membranes prior to 37 weeks gestation and prior to the onset of labor
Tocolysis: A medical intervention for the purpose of active inhibition of uterine contractions
Tocolytic drug: Any drug used to suppress premature labor (e.g., ritodrine or terbutaline)
Coding
The following codes for treatments and procedures applicable to this policy are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.
When services may be Medically Necessary when criteria are met:
HCPCS
ICD-9 Diagnoses
When services are Not Medically Necessary: For the procedure codes listed above for HUAM used at or after 24 weeks gestation, when criteria are not met.
When services are Investigational/Not Medically Necessary: For the procedure codes listed above when criteria are not met, or when the code describes a procedure indicated in the Policy section as investigational/not medically necessary.
When services may be Medically Necessary when criteria are met:
HCPCS
ICD-9 Diagnoses
When services are Investigational/Not Medically Necessary: For the procedure code listed above when criteria are not met, or when the code describes a procedure indicated in the Policy section as investigational/not medically necessary.
References
Peer Reviewed Publications:
Government Agency, Medical Society, and Other Authoritative Publications:
Web Sites for Additional Information
Index
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. Policy History
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Federal and State law, as well as contract language, including definitions and specific contract provisions/exclusions, take precedence over Medical Policy and must be considered first in determining eligibility for coverage. The member's contract benefits in effect on the date that services are rendered must be used. Medical Policy, which addresses medical efficacy, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and we reserve the right to review and update Medical Policy periodically. No part of this publication may be reproduced, stored in a retrieval system or transmitted, in any form or by an means, electronic, mechanical, photocopying, or otherwise, without permission from the health plan. ©CPT Only - American Medical Association |