Home Uterine Activity Monitoring (HUAM)
DESCRIPTION
The home uterine activity monitor (HUAM) is a device intended to provide early detection of preterm labor in women at high risk of developing preterm labor and preterm birth. The monitoring device consists of a guard-ring tocodynamometer (worn as a belt around the abdomen), a date recorder, and a date transmitter. Usually, the individual is instructed to use the device daily for two 1-hour periods. After monitoring, the individual 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 individual to assess signs and symptoms and to provide advice and counseling.
Nurses employed in HUAM services look for evidence of the onset of preterm labor. This evidence is based on uterine activity exceeding a threshold level or from findings of a telephone interview with the individual.
POLICY
Home uterine activity monitoring through a monitoring device and/or daily nursing contact is considered not medically necessary.
Home uterine activity monitoring for all other uses is considered not medically necessary.
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
Home uterine activity monitoring (HUAM) is considered not medically necessary in the vast majority of instances because the scientific evidence does not demonstrate that the use of HUAM will improve net health outcomes. It has not been proven to be as beneficial as any established alternatives and no improvement has been demonstrated outside the investigational setting.
SOURCES
American College of Obstetricians and Gynecologists Committee on Practices-Obstetrics, Society for Maternal-Fetal Medicine, & ACOG Joint Editorial Committee. (2009). ACOG Practice Bulletin. Clinical management guidelines for obstetrician-gynecologists. Number 56: Multiple gestation: Complicated twin, triplet, and high-order multifetal pregnancy. Obstetrical & Gynecology, 104 (4), 869-883.
American College of Obstetricians and Gynecologists. ACOG Committee on Ethics. (2006). ACOG Committee Opinion. Number 352. Innovative practice: Ethical guidelines. Retrieved July 15, 2010 from http://www.acog.org/from_home/publications/ethics/co352.pdf.
BlueCross BlueShield Association. Medical Policy Reference Manual. (2009, December). Home uterine activity monitoring (4.01.09). Retrieved July 15, 2010 from BlueWeb. (12 articles and/or guidelines reviewed)
Ehrenberg, H. M., Iams, J. D., Goldenberg, R. L., Newman, R. B., Weiner, S. J., Sibai, B. M., et al. (2009). Maternal obesity, uterine activity, and the risk of spontaneous preterm birth. Obstetrical & Gynecological, 113 (1), 48-52. (Level 1 Evidence - Independent study)
Gabbe, S. G., Niebyl, J. R., & Simpson, J. L. (Eds.) (2007). Obstetrics: Normal and problem pregnancies (5th ed., Chapter 28). Philadelphia: Elsevier Inc.
Technology Evaluation Center. (1996, October). Home uterine activity monitoring for secondary prevention of preterm birth (Vol. 11, No. 15). Chicago: BlueCross BlueShield Association. (29 articles and/or guidelines reviewed)
U. S. Food and Drug Administration. (1995, September). Center for Devices and Radiological Health. System 37® home uterine monitoring system - P920038. Retrieved July 15, 2010 from http://www.accessdata.fda.gov/cdrh_docs/pdf/p920038.pdf.
U. S. Food and Drug Administration. (1995, September). Center for Devices and Radiological Health. CareFone home uterine activity monitoring system - P910063. Retrieved July 15, 2010 from http://www.accessdata.fda.gov/cdrh_docs/pdf/p910063.pdf.
U. S. Food and Drug Administration. (2002, April). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K020390. Retrieved July 27, 2010 from http://www.accessdata.fda.gov/cdrh_docs/pdf2/K020390.pdf.
U. S. Food and Drug Administration. (2009, April). Center for Devices and Radiological Health. Code of Federal Regulations: Title 21: Volume 8: 21CFR884.2730: Part 884 Obstetrical and gynecological devices: Subpart C - Obstetrical and gynecological monitoring devices. Section 884.2730. Home uterine activity monitor. Retrieved July 15, 2010 from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=884.2730.
Urquhart C, Currell R, Callow E, Harlow F. Home uterine monitoring for detecting preterm labor (Protocol) Cochrane Database of Systematic Reviews 2006, Issue 4. Art. No.: CD006172. DOI: 10.1002/14651858. CD006172.
Winifred S. Hayes, Inc. Medical Technology Directory. (2008, January). Home uterine activity monitoring. Retrieved July 15, 2010 from www.Hayesinc.com/subscribers. (78 articles and/or guidelines reviewed)
ORIGINAL EFFECTIVE DATE: 12/1985
MOST RECENT REVIEW DATE: 12/11/2010
ID_BT
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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