BlueCross BlueShield of Tennessee Medical Policy Manual

Negative Pressure Wound Therapy in the Outpatient Setting

DESCRIPTION

Negative pressure wound therapy (NPWT) consists of the use of a negative pressure therapy or suction device to aspirate and remove fluids, debris, and infectious materials from the wound bed to promote the formation of granulation tissue. These devices may also be used as an adjunct to surgical therapy or as an alternative to surgery in a debilitated patient.

NPWT uses a specialized dressing and vacuum drainage to remove blood or serous fluid from a wound or operation site while maintaining a moist wound environment. It is delivered through an integrated system of a suction pump, separate exudate collection chamber and dressing sets to a qualified wound. When the exposed end of the drain tube is connected to sub-atmospheric pressure or a vacuum source, fluid is drawn from the wound through the foam into a reservoir, for subsequent disposal. Negative pressure wound therapy may be delivered using mechanically powered or electrically powered devices.

Portable negative pressure wound therapy devices that do not use a power source are being developed that are both lightweight and disposable. However, these devices have had limited clinical trials. The use of NPWT should always be part of a comprehensive wound care program that includes frequent monitoring by a trained practitioner, nutritional counseling that includes adequate protein and calorie intake, Vitamin C and Zinc supplements as well as appropriate physical therapy.

POLICY

See also:

MEDICAL APPROPRIATENESS

IMPORTANT REMINDERS

ADDITIONAL INFORMATION

Evidence from comparative clinical trials demonstrated that there is a subset of problematic wounds for which the use of NPWT may provide a significant clinical benefit. However, due to clinical variability and limited data, it is not possible to determine prospectively which wounds are most likely to respond favorably to NPWT. Therefore, the policy indicates that a therapeutic trial of NPWT of 30 days is considered medically necessary for chronic wounds that have failed to heal, despite intense conventional wound therapy.

Reports with small numbers of individuals using the non-powered (mechanical) gauze-based NPWT system are insufficient to draw conclusions about its impact on net health outcome, both for the device itself and in comparison with current care.

SOURCES 

Acosta, S., Björck, M., & Petersson, U. (2017). Vacuum-assisted wound closure and mesh-mediated fascial traction for open abdomen therapy – a systematic review. Anaesthesiology Intensive Therapy, 49 (2), 139-145. Abstract retrieved June 26, 2017 from PubMed database.

Agency for Healthcare Research and Quality. (September, 2014). Report on negative pressure wound therapy technologies for chronic wound care in the home setting. Retrieved October 13, 2015 from http://www.ahrq.gov.

BlueCross BlueShield Association. Medical Policy Reference Manual. (1:2017) Negative pressure wound therapy in the outpatient setting. (1.01.16) Retrieved June 26, 2017 from BlueWeb. (42 articles and/or guidelines reviewed)

DeVries, F., Wallert, E., Solomkin, J., Allegranzi, B., Egger, M., Dellinger, E., & Boermeester, M. (2016). A systematic review and meta-analysis including GRADE qualification of the risk of surgical site infections after prophylactic negative pressure wound therapy compared with conventional dressings in clean and contaminated surgery. Medicine, 95 (36), e4673. Abstract retrieved June 26, 2017 from PubMed database.

Liu, S., He, C., Cai, Y., Xing, Q., Guo, Y., Chen, Z, et al. (2017). Evaluation of negative-pressure wound therapy for patients with diabetic foot ulcers: systematic review and analysis. Therapeutics and Clinical Risk Management, 2017:13, 533-534. (Level 2 evidence)

National Government Services. CMS.gov. (2017, January). LCD for outpatient physical and occupational therapy services (L33631). Retrieved June 26, 2017 from https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=33631.

National Institute for Health and Care Excellence. (November, 2013). Negative pressure wound therapy for the open abdomen. Retrieved October 7, 2015 from: http://www.nice.org.uk.

Reddy, V. S. (2016). Use of closed incision management with negative pressure therapy for complex cardiac patients. Cureus, 8 (2), e506. Abstract retrieved July 19, 2016 from PubMed database.

Tricco, A., Antony, J., Vafaei, A., Khan, P., Harrington, A., Cogo, E., et al. (2015). Seeking effective interventions to treat complex wounds: an overview of systematic reviews. BMC Medicine (2015) 13:89. (Level 1 evidence)

U. S. Food and Drug Administration. (2011, July). Center for Devices and Radiologic Health. 510(k)Premarket Notification Database. K111006. Retrieved October 7, 2015 from http://www.fda.gov.

U. S. Food and Drug Administration. (2013, November). Center for Devices and Radiologic Health. 510(k) Premarket Notification Database. K132741. Retrieved October 7, 2015 from http://www.fda.gov.

U. S. Food and Drug Administration. (2008, September). Center for Devices and Radiologic Health. 510(k) Premarket Notification Database. K082426. Retrieved October 7, 2015 from http://www.fda.gov.

U. S. Food and Drug Administration. (2015, August). Center for Devices and Radiological Health. 510(k) Pre-market Notification Database. K141017. Retrieved July 19, 2016 from http://www.accessdata.fda.gov/cdrh_docs/pdf14/K141017.pdf.

U. S. Food and Drug Administration. (2015, November). Center for Devices and Radiological Health. 510(k) Pre-market Notification Database. K150006. Retrieved July 19, 2016 from http://www.accessdata.fda.gov/cdrh_docs/pdf15/K150006.pdf.

U. S. Food and Drug Administration. (2016, February). Center for Devices and Radiological Health. 510(k) Pre-market Notification Database. K153199. Retrieved July 19, 2016 from http://www.accessdata.fda.gov/cdrh_docs/pdf15/K153199.pdf.

Winifred S. Hayes, Inc. Medical Technology Directory. (2012, July; last update search July, 2016). Negative pressure wound therapy for wounds other than sternal wounds and skin grafts. Retrieved July 19, 2016 from www.Hayesinc.com/subscribers (131 articles and/or guidelines reviewed)

Winifred S. Hayes, Inc. Medical Technology Directory. (2016, December). Negative pressure wound therapy for chronic wounds: home use. Retrieved June 26, 2017 from www.Hayes.com/subscribers. (75 articles and/or guidelines reviewed).

ORIGINAL EFFECTIVE DATE:  11/18/2015

MOST RECENT REVIEW DATE:  8/10/2017

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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