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DESCRIPTIONThe home uterine activity monitor (HUAM) is a device intended to provide early detection of preterm labor (PTL) in women at high risk of developing PTL and preterm birth (PTB). The monitoring device consists of a guard-ring tocodynamometer (worn as a belt around the abdomen), a data recorder, and a data transmitter. Usually, the patient is instructed to use the device daily for two 1-hour periods. After monitoring, the patient is supposed to transmit the recordings by telephone modem link to a remote base station. Base station nurses not only facilitate transmission and analysis of the monitor tracings, they also maintain daily telephone contact with the patient to assess signs and symptoms and to provide advice and counseling.
Nurses employed in HUAM services look for evidence of the onset of PTL, either on the basis of uterine activity exceeding a threshold level or from the findings of a telephone interview with the patient. Signs and symptoms of PTL include back pain, increased vaginal discharge, menstrual-like cramps, and pelvic pressure or heaviness. The threshold number of uterine contractions signaling the possible onset of PTL is usually 4 to 6 per hour. If signs and symptoms are present or the uterine activity exceeds a certain threshold, patients are instructed to perform the following: empty the bladder, hydrate orally, and assume the left lateral recumbent position. The patient is also instructed to remonitor for 1 additional hour. If uterine activity still exceeds threshold or signs and symptoms persist, the patient is instructed to see her physician immediately for a cervical examination. The cervical examination would then play a pivotal role in diagnosing whether PTL is occurring and whether to initiate tocolytic therapy.
In March 2001, the U.S. Food and Drug Administration (FDA) reclassified HUAMs from class III (Premarket Approval) to class II (Special Controls) devices. The HUAM is a post-amendment device and thus, was automatically reclassified into class III. Devices with 510(k) marketing clearance from the FDA include the Fetal Assist (Huntleigh Diagnostics, Eatontown, NJ) and the Carefone Home Uterine Activity Monitoring System (Carelink Corp, Santa Ana, CA). The HUAM is described as an electronic system for at home antepartum measurement of uterine contractions, data transmission by telephone to a clinical setting, and for receipt and display of the uterine contraction data at the clinic. The HUAM system comprises a tocotransducer, an at-home recorder, a modem, and a computer and monitor that receive, process, and display data. The FDA indicates that the device is intended for use in women at least 24 weeks’ gestation with a previous preterm delivery to aid in the detection of preterm labor.
Related medical policies include Acute and Maintenance Tocolysis and Progesterone Therapy as a Technique to Reduce Preterm Birth in High-Risk Pregnancies.
POLICYThe daily use of a home uterine activity monitor (HUAM) and/or daily nursing contact is considered not medically necessary and not eligible for coverage under any and all settings and situations.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
Investigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY5/1999: Approved by Medical Policy Advisory Committee (MPAC)
2/2001: Reviewed by MPAC; status changed to investigational
2/13/2002: Investigational definition added
5/1/2002: Type of Service and Place of Service deleted
9/20/2002: Policy reviewed, Sources updated
7/2003: Reviewed by MPAC, investigational status remains, HCPCS S9001 added
2/20/2006: Code Reference table updated and reformatted, BCBSMS local codes H0800, H0801, H0802 were deleted
3/16/2006: Policy reviewed, no changes
9/28/2006: Code reference section updated. CPT code 99500 and ICD-9 procedure code 75.34 added to policy
4/25/2008: Based on the accumulating evidence that home uterine activity monitoring does not accurately predict preterm labor or improve health outcomes, the policy statement was changed to state that home monitoring is considered not medically necessary. (previously this was investigational)
04/22/2010: Policy description updated. Added “and/or daily nursing contact” to the policy statement for clarification; intent unchanged. FEP verbiage added to the Policy Exceptions section. Deleted outdated references from the Sources section.
12/28/2010: Policy reviewed; no changes.
01/17/2012: Policy reviewed; no changes.
03/13/2013: Policy reviewed; no changes.
SOURCE(S)Blue Cross Blue Shield Association policy #4.01.09
CODE REFERENCEThis is not an all-inclusive list of non-covered procedure codes.
All codes billed for this procedure are considered investigational and not eligible for coverage.