Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Home Uterine Activity Monitoring (HUAM) Devices

Policy #:05.00.65e

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


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.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract.

Although the US Food and Drug Administration (FDA) has approved home uterine activity monitor (HUAM) systems, 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, home uterine activity monitors (HUAMs) 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.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

There are numerous devices approved by the FDA for home uterine monitoring.
Description

The home uterine activity monitor (HUAM) is a device intended to provide 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.

HUAM systems are approved by the US Food and Drug Administration (FDA). 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) (reaffirmed in 2016), 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 for early detection of PTL and PTB in women who are at high risk for these conditions.
References

American College of Obstetricians and Gynecologists; Committee on Practice Bulletins—Obstetrics. ACOG practice bulletin no. 171: Management of preterm labor. Obstet Gynecol. 2016;128:e155–64 (Interim Update).


American College of Obstetricians and Gynecologists (ACOG). Innovative practice: Ethical guidelines. Obstet Gynceol. 2006:108(6):1589-1895.

American College of Obstetricians and Gynecologists; Committee on Practice Bulletins—Obstetrics. ACOG practice bulletin no. 159: Management of preterm labor. Obstet Gynecol. 2016;127(1): e29–38. (Replaced by Practice Bulletin 171).

American College of Obstetricians and Gynecologists (ACOG). Practice Bulletin No. 130: Prediction and Prevention of Preterm Birth. Obstet Gynecol. 2012;120:964–73. Reaffirmed 2016.

Blondel B, Breart G, Berthoux Y, et al. Home uterine activity monitoring in France: a randomized, controlled trial. Am J Obstet Gynecol. 1992; 167(2):424-9.

Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Home uterine activity monitoring for secondary prevention of preterm birth. TEC Assessments 1996; Volume 11, Tab 15.

Brown HL, Britton KA, Brizendine EJ, et al. A randomized comparison of home uterine activity monitoring in the outpatient management of women treated for preterm labor. Am J Obstet Gynecol. 1999;180(4):798-805.

Collaborative Home Uterine Monitoring Study (CHUMS) Group. A multicenter randomized controlled trial of home uterine monitoring: active versus sham device. Am J Obstet Gynecol. 1995;173(4):1120-7.

Committee on Understanding Premature Birth and Assuring Healthy Outcomes. 2007. 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 November 29, 2017.

Dyson DC, Danbe KH, Bamber JA, et al. Monitoring women at risk for preterm labor. N Engl J Med. 1998;338(1):15-9.

Honest H, Forbes CA, Duree KH, et al. Screening to prevent spontaneous preterm birth: systematic reviews of accuracy and effectiveness literature with economic modeling. Health Technol Assess. 2009;13 (43):1-627.

Iams JD, Johnson FF, O’Shaughnessy RW. Ambulatory uterine activity monitoring in the post-hospital care of patients with preterm labor. Am J Perinatol. 1990;7(2):170-3.

Iams JD, Newman RB, Thom EA, et al. Frequency of uterine contractions and the risk of spontaneous preterm delivery. N Engl J Med. 2002 Jan 24;346(4):250-5.

Nagey DA, Bailey-Jones C, Herman AA. Randomized comparison of home uterine activity monitoring and routine care in patients discharged after treatment for preterm labor. Obstet Gynecol. 1993; 82(3):319-23.

National Institute of Child Health and Human Development. Home uterine monitors not useful for predicting premature birth. January 23, 2002. Available online at: http://www.nichd.nih.gov/news/releases/uterine.cfm. Last accessed November 29, 2017.

Rittenberg C, Newman RB, Istwan NB, et al. Preterm birth prevention by 17 alpha-hydroxyprogesterone caproate vs. daily nursing surveillance. J Reprod Med. 2009;54(2):47-52.

Urquhart C, Currell R, Harlow F, et al. Home uterine monitoring for detecting preterm labour. Cochrane Database Syst Rev. 2012;5:CD006172.

Urquhart C, Currell R, Harlow F, et al. Home uterine monitoring for detecting preterm labour. Cochrane Database Syst Rev. 2017;2:CD006172.

Urquhart C, Currell R, Harlow F, et al. Home uterine monitoring for detecting preterm labour. Cochrane Database Syst Rev. 2015; 1:CD006172.

US Food and Drug Administration (FDA). Devices@FDA. 884.2730 Home uterine activity monitor. [FDA Web site]. Original: 03/09/01. (Revised: 04/01/17). Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=884.2730. Accessed November 29, 2017.

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 November 29, 2017.

US Food and Drug Administration (FDA). Final Guidance for Industry and FDA Reviewers: Class II Special Controls Guidance for Home Uterine Activity Monitors. Original: 03/9/01 (Page last updated 07/13/2015). Available at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm237292.htm. Accessed November 29, 2017.




Coding

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.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

N/A


HCPCS Level II Code Number(s)

S9001 Home uterine monitor with or without associated nursing services


Revenue Code Number(s)

N/A

Coding and Billing Requirements



Policy History

Revisions from 05.00.65e:
02/15/2018This policy has undergone a routine review, and no revisions have been made.
Version Effective Date: 02/22/2017
Version Issued Date: 02/22/2017
Version Reissued Date: 02/15/2018

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Independence Blue Cross is an independent licensee of the Blue Cross and Blue Shield Association, serving the health insurance needs of Philadelphia and southeastern Pennsylvania.