Medical Policies Online - Policy #: 05.00.65c

Medical Policy Bulletin

Title:

Home Uterine Activity Monitoring (HUAM) Devices

Policy #:

05.00.65c

The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.

Intent

The intent of this policy is to communicate that the use of a home uterine activity monitor (HUAM) is considered not medically necessary.

Description

The home uterine activity monitor (HUAM) is a device intended to provide the early detection of preterm labor (PTL) in women at high risk for PTL and preterm birth (PTB). The monitoring device consists of a pressure sensor (tocodynamometer) that is held against the abdomen by a belt, and a device that is attached to a shoulder strap to record, store, and transmit data.

The US Food and Drug Administration (FDA) has approved two HUAM systems: the Healthdyne™ System 37 Home Uterine Activity Monitoring System (Matria Healthcare; Marietta, GA) and the Genesis™ Home Uterine Activity Monitoring System (CareLink Corporation; Santa Ana, CA). In conjunction with standard high-risk care, these systems are indicated for the daily at-home measurement of uterine activity in women with pregnancies of at least 24 weeks' gestation who also have a history of preterm delivery.

According to the American College of Obstetricians and Gynecologists (ACOG), and based on a review of the available published literature on the use of a HUAM to provide early detection of PTL in women at high risk for PTL and PTB, the effectiveness of a HUAM in improving health outcomes in these individuals has not been established. Therefore, there is inconclusive evidence on the use of a HUAM in the treatment of early detection of PTL and PTB in women who are at high risk for these conditions.

Policy

Although the US Food and Drug Administration (FDA) has approved systems for home uterine activity monitoring (HUAM), the Company has determined that the available published peer-reviewed literature does not support the service as a useful aid in the treatment of preterm labor (PTL). Therefore, HUAM systems are considered not medically necessary by the Company and not covered.

Guidelines

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, HUAM is are not eligible for payment under the medical benefits of the Company’s products because the service is considered not medically necessary and, therefore, not covered.

MEDICARE

There is no Medicare coverage criteria addressing this service; therefore, the Company policy is applicable.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

Home uterine activity monitors (HUAM) were classified by the FDA on March 9, 2001, as Class II (Special Controls) devices. The Genesis™ Home Uterine Activity Monitoring System (CareLink Corporation; Santa Ana, CA) and the Healthdyne™ System 37 Home Uterine Activity Monitoring System (Matria Healthcare; Marietta, GA) have both obtained FDA approval.

References

American College of Obstetricians and Gynecologists (ACOG). Innovative practice: Ethical guidelines. Obstet Gynceol. 2006:108(6):1589-1895. Also available online at: http://www.acog.org/from_home/publications/ethics/co352.pdf. Accessed January 28, 2010.

American College of Obstetricians and Gynecologists (ACOG) Practice Bulletin. Clinical Management Guidelines for Obstetrician- Gynecologists. Number 31. October 2001. Reaffirmed 2008.

Committee on Understanding Premature Birth and Assuring Healthy Outcomes. Preterm birth: Causes, consequences, and prevention. Section III: Diagnosis and treatment of preterm labor, Chapter Nine: Diagnosis and treatment of conditions leading to spontaneous preterm birth. Also available online at: http://books.nap.edu/openbook.php?record_id=11622&page=R1. Accessed January 28, 2010.

US Food and Drug Administration (FDA). Federal Register. Obstetrics and gynecology devices; reclassification of home uterine activity monitor. Docket No. 97P-0350. [FDA Web site]. 07/30/99. Available at: http://www.fda.gov/ohrms/dockets/98fr/073099b.txt. Accessed January 28, 2010.

US Food and Drug Administration (FDA). CFR Code of Federal Regulations. Title 21, Volume 8. Home uterine activity monitor. Class II. [FDA Web site]. Original: 03/09/01. (Revised: 04/01/09). Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=884&showFR=1&subpartNode=21:8.0.1.1.28.3. Accessed January 28, 2010.

Coding Table

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

Code System	Code Number(s) and Narrative(s)
CPT	N/A
ICD Procedure	N/A
ICD Diagnosis	The use of a home uterine activity monitor (HUAM) is considered not medically necessary for all diagnoses.
HCPCS Level II	THE FOLLOWING CODE IS CONSIDERED NOT MEDICALLY NECESSARY AND, THEREFORE, NOT COVERED S9001: Home uterine monitor with or without associated nursing services
Revenue Codes	N/A

Version Effective Date: 04/01/2008