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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

09-E0000-37

Original Effective Date: 04/15/01

Reviewed: 07/24/14

Revised: 11/01/15

Subject: Negative Pressure Wound Therapy (NPWT) Pumps (electric powered or mechanical)

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

Position Statement

Billing/Coding

Reimbursement

Program Exceptions

Definitions

Related Guidelines

Other

References

Updates

Decision Tree

 

Previous Version

DESCRIPTION:

The management and treatment of chronic wounds, including decubitus ulcers, remain a treatment challenge. Most chronic wounds will heal only if the underlying cause, i.e., venous stasis, pressure, infection, etc., is addressed. In addition, cleaning the wound to remove non-viable tissue, microorganisms, and foreign bodies is essential to create the optimal conditions for either re-epithelialization (i.e., healing by secondary intention) or preparation for wound closure with skin grafts or flaps (i.e., healing by primary intention). Therefore, debridement, irrigation, whirlpool treatments, and wet-to-dry dressings are common components of chronic wound care.

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 and debris from the wound bed to promote the formation of granulation tissue. The devices may be used as an adjunct to surgical therapy or as an alternative to surgery in a debilitated patient. Although the exact mechanism has not been elucidated, it is hypothesized that negative pressure contributes to wound healing by removing excess interstitial fluid, increasing the vascularity of the wound, and/or creating beneficial mechanical forces that draw the edges of the wound closer together.

A non-powered (mechanical) NPWT system has also been developed; one device is the Smart Negative Pressure (SNaP) Wound Care System. This device is portable and lightweight (3 oz.) and can be worn underneath clothing. This system consists of a cartridge, dressing, and strap; the cartridge acts as the negative pressure source. The system is reported to generate negative pressure levels similar to other NPWT systems. This system is fully disposable.

Portable battery-powered, single-use NPWT devices are being investigated for treating certain types of wounds. One such device is the PICO Single Use Negative Pressure Wound Therapy System (manufactured by Smith-Nephew, Inc.) which is designed to stop working after 168 hours (7 days) of use and will not re-start after this time, even when new batteries are installed.

The focus of this document is on use of NPWT in the outpatient setting.

POSITION STATEMENT:

Ulcers or wounds in the home setting

Electric (powered) vacuum-assisted wound closure devices meet the definition of medical necessity when the following criteria are met:

1. The member has a Stage III or IV pressure ulcer, neuropathic ulcer (e.g., diabetic), venous or arterial insufficiency ulcer, a chronic ulcer of mixed etiology (i.e., present for 30 days or more); or complication of a surgically created wound AND

Other wound therapy has been attempted and failed, including all of the following:

2. NPWT was applied during an inpatient acute facility stay or outpatient surgery facility, either while in the operating room or post operatively due to complications of a surgically created wound or traumatic wound requiring accelerated granulation tissue that cannot be achieved by other methods.

In addition to the above criteria

For stage III or IV pressure ulcers:

For neuropathic ulcers:

For venous or arterial insufficiency ulcers:

Ulcers and wounds encountered in an inpatient setting

Vacuum-assisted wound closure devices meet the definition of medical necessity for either of the following:

In either situation, NPWT meets the definition of medical necessity when treatment continuation is ordered at the time of discharge to the home setting.

Continuation of Coverage

In order for coverage to continue, the medical records (i.e., physician initial assessment, physician visit notes) must indicate that a licensed medical professional (i.e. physician, PA, RN, LPN, or RPT) has completed all of the following:

Discontinuation of Negative Pressure Wound Therapy

Discontinuation of NPWT may occur with any of the following:

Wound healing is described as:

Vacuum-assisted wound closure devices are contraindicated when the following conditions exist:

Use of non-powered (mechanical) NPWT systems for the treatment of acute or chronic wounds is considered experimental or investigational as the available clinical evidence published in the peer-reviewed literature does not support efficacy or long-term improvements on health outcomes. Further well-designed comparative studies with large numbers of patients are needed.

Portable single-use negative pressure wound therapy devices (e.g., PICO Single Use Negative Pressure Wound Therapy System; Prevena Incision Management System) are considered experimental or investigational. There is insufficient clinical evidence published in the peer-reviewed literature to determine safety and efficacy for the use of these devices in wound care therapy.

BILLING/CODING INFORMATION:

The following codes may be used to describe vacuum-assisted wound closure devices and associated supplies used in performing this therapy.

CPT Coding:

97605

Negative pressure wound therapy (e.g. vacuum assisted drainage collection), utilizing durable medical equipment (DME), including topical application(s), wound assessment, and instruction(s) for ongoing care, per session; total wound(s) surface area less than or equal to 50 square centimeters

97606

Negative pressure wound therapy (e.g. vacuum assisted drainage collection), utilizing durable medical equipment (DME), including topical application(s), wound assessment, and instruction(s) for ongoing care, per session; total wound(s) surface area greater than 50 square centimeters

97607

Negative pressure wound therapy, (e.g., vacuum assisted drainage collection), utilizing disposable, non-durable medical equipment including provision of exudate management collection system, topical application(s), wound assessment, and instructions for ongoing care, per session; total wound(s) surface area less than or equal to 50 square centimeters (investigational)

97608

Negative pressure wound therapy, (e.g., vacuum assisted drainage collection), utilizing disposable, non-durable medical equipment including provision of exudate management collection system, topical application(s), wound assessment, and instructions for ongoing care, per session; total wound(s) surface area greater than 50 square centimeters (investigational)

HCPCS Coding:

A6550

Wound care set, for negative pressure wound therapy electrical pump, includes all supplies and accessories

A7000

Canister, disposable, used with suction pump, each

A9272

Wound suction, disposable, includes dressing and all accessories and components, each (investigational)

E2402

Negative pressure wound therapy electrical pump, stationary or portable

K0743

Suction pump, home model, portable, for use on wounds (investigational)

K0744

Absorptive wound dressing for use with suction pump, home model, portable, pad size 16 square inches or less

K0745

Absorptive wound dressing for use with suction pump, home model, portable, pad size more than 16 square inches but less than or equal to 48 square inches

K0746

Absorptive wound dressing for use with suction pump, home model, portable, pad size greater than 48 square inches

NOTE: A6550 (dressing set) includes all necessary components (i.e., resilient, open-cell foam surface dressing, drainage tubing, and occlusive dressing).

NOTE: A9272, K0743 – K0746 describe portable suction pumps (e.g., the Kalypto® NPD 1000 NPWT wound care kit) and the associated wound dressings. These dressings apparently have material in the center that absorbs and “locks-in” any exudates; therefore, no container is needed for the wound exudates. A tube connects the dressing to the device (a programmable “lightweight pump”) which can provide intermittent or continuous pumping. The pump in K0743 is not disposable and is not meant to be used for reporting disposable devices. These portable pumps and dressings would be used in lieu of, and not in addition to A6550, A7000, and E2402. Portable non-powered (mechanical) pumps (K0743) are considered experimental or investigational; therefore, associated supplies used with these devices would be non-covered.

REIMBURSEMENT INFORMATION:

When the above criteria are met, as listed in the section entitled POSITION STATEMENT, reimbursement for vacuum-assisted wound closure devices is limited to 4 months.

Reimbursement for the use of these devices beyond 4 months will be covered only when medical necessity continues to be met as outlined above and when there is evidence of clear benefit from treatment already received using the device.

Because negative pressure wound therapy pumps are capable of accommodating more than one wound dressing set for multiple wounds on a member, reimbursement for more than one pump per member for the same time period is not considered medically necessary.

Reimbursement for the following supplies used with a covered negative pressure wound therapy pump is limited to the following:

A6550

dressing kit

15 dressing kits per wound, per month

A7000

canister set

10 per month unless there is documentation evidencing a large volume of drainage (greater than 90 ml of exudate per day).

Supplies in excess of the above limitations are subject to medical review for medical necessity.

The following information may be required documentation to support medical necessity: Physician history and physical, physician treatment notes including documentation of failure conservative medical management, treatment plan, radiology and surgical reports, physical therapy notes (if applicable).

LOINC Codes:

Documentation Table

LOINC Codes

LOINC
Time Frame
Modifier Code

LOINC Time Frame Modifier Codes Narrative

Physician history and physical

28626-0

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Physician treatment/ visit notes including documentation of failure of conservative medical management

18733-6

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Treatment plan

18776-5

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Radiology study report

18726-0

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Physician operative note

28573-4

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Physical therapy notes

28579-1

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage Products:

The following Durable Medical Equipment Regional Carrier (DMERC) Local Coverage Determination (LCD) was reviewed on the last guideline reviewed date: Negative Pressure Wound Therapy Pumps (L5008) located at cgsmedicare.com.

DEFINITIONS:

Granulation tissue: tissue made up of granulations that temporarily replaces lost tissue in a wound.

Neuropathic ulcer: an ulcer resulting from separation of tissue from its nerve supply, such as in diabetic neuropathy.

Reepithelialization: the reproduction of epithelial tissue over a denuded (bare) surface (wound).

Stage III pressure ulcer: full thickness skin loss involving damage or necrosis of subcutaneous tissue that may extend down to, but not through, underlying fascia.

Stage IV pressure ulcer: full thickness skin loss with extensive destruction, tissue necrosis or damage to muscle, bone, or supporting structures.

RELATED GUIDELINES:

None applicable.

OTHER:

Other indexing terms:

Note: The use of specific product names is illustrative only. It is not intended to be a recommendation of
one product over another, and is not intended to represent a complete listing of all products available.

ActiV.A.C.® Therapy Unit

Engenex® Advanced NPWT System

Exusdex® wound drainage pump

EZCARE Negative Pressure Wound Therapy

InfoV.A.C.® Therapy Unit

Invia Liberty Wound Therapy

Invia Vario 18 c/i Wound Therapy

Mini V.A.C.®
Neo-Gen Technologies NeoGen One
NPD 1000 Negative Pressure Wound Therapy System

PICO Single Use Negative Pressure Wound Therapy System (Smith-Nephew)

Prevena Incision Management System

Prodigy™ NPWT System (PMS-800 and PMS-800V)

PRO-I™

PRO-II™

PRO-III™

Renasys™ EZ Negative Pressure Wound Therapy System
Smart Negative Pressure (SNaP) Wound Care System
SVEDMAN™ and SVED™ Wound Treatment Systems

V.A.C.® ATS™

V.A.C.® Freedom™

V.A.C.® Instill Device

V.A.C.® Therapy Unit

Vacuum Assisted Closure V.A.C.® Therapy System

Venturi™ NPWT v.II Advanced Vacuume System

V1STA Negative Pressure Wound Therapy

REFERENCES:

  1. Agency for Health Care Research and Quality (AHRQ). Technology Assessment Report by ECRI. Negative pressure wound therapy devices. (05/26/09, corrected 11/12/09).
  2. Agency for Healthcare Research and Quality (AHRQ), Evidence Report/Technology Assessment: “Wound-Healing Technologies: Low-Level Laser and Vacuum-Assisted Closure” (12/04, archived).
  3. Agency for Healthcare Research and Quality (AHRQ) Comparative Effectiveness Review Number 90. Pressure Ulcer Treatment Strategies: Comparative Effectiveness Executive Summary (May, 2013)
  4. Agency for Healthcare Research and Quality (AHRQ) Negative Pressure Wound Therapy Devices Technology Assessment Report Project ID: WNDT1108 (11/12/09).
  5. American College of Surgeons. FDA to Strengthen Rules for Home Use of Devices by Alicia Ault, Elsevier Global Medical News; published online 04/21/10.
  6. American Society of Plastic Surgeons (ASPS). Evidence-based Clinical Practice Guideline: Chronic Wounds of the Lower Extremity. 2007.
  7. Armstrong DG, Marston WA, Reyzelman AM et al. Comparison of negative pressure wound therapy with an ultraportable mechanically powered device vs. traditional electrically powered device for the treatment of chronic lower extremity ulcers: a multicenter randomized-controlled trial. Wound Repair Regen 2011;19(2):173-80.
  8. Armstrong DG, Marston WA, Reyzelman AM et al. Comparative effectiveness of mechanically and electrically powered negative pressure wound therapy devices: a multicenter randomized controlled trial. Wound Repair Regen 2012; 20(3):332-41.
  9. Association for the Advancement of Wound Care (AAWC). Summary algorithm for venous ulcer care with annotations of available evidence. Malvern (PA): Association for the Advancement of Wound Care (AAWC); 2005. 25 p.
  10. Blue Cross Blue Shield Association Medical Policy 1.01.16. Negative Wound Pressure Therapy in the Outpatient Setting, (04/11/13).
  11. Blue Cross Blue Shield Association TEC Assessment, “Vacuum-Assisted Wound Closure Devices”, (2000).
  12. Centers for Medicare and Medicaid Services CMS Pub. 100-8, Medicare Program Integrity Manual, Chapter 4 - Benefit Integrity, Chapter 4.26.1 - Proof of Delivery and Delivery Methods (Effective 10/31/11).
  13. ECRI. Technology Assessment Report. Negative Pressure Wound Therapy Devices (05/26/09; 11/12/09)
  14. ECRI. Target Database, Vacuum-assisted Wound Closure, (07/02).
  15. ECRI. Windows on Technology: “Vacuum-assisted Wound Closure for Chronic and Acute Wounds” (10/00).
  16. ECRI Product Brief. InfoV.A.C. (KCI, Inc.) and Invia Liberty (Medela Healthcare) for Negative Pressure Wound Therapy (11/21/12).
  17. ECRI Product Brief. PICO Single-use System (Smith & Nephew, Inc.) for Delivering Negative Pressure Wound Therapy (06/01/12).
  18. ECRI Product Brief. Prevena Incision Management System (Kinetic Concepts, Inc.) for Managing Closed Surgical Incisions (02/01/12).
  19. Fong, KD, D. Hu, et al. “Initial Clinical Experience Using the Novel Ultraportable Negative Pressure Wound Therapy Device.” Plast. Reconstr. Surg. 125: 1362, 2010.
  20. Fong KD, Hu D, et al. The SNaP System: Biomechanical and Animal Model Testing of a Novel Ultraportable Negative-Pressure Wound Therapy System. Plast Reconstr Sug. 125(5): 1362-1371.
  21. Frykberg RG, Zgonis T, Armstrong DG, Driver VR, Giurini JM, Kravitz SR, Landsman AS, Lavery LA, Moore C, Schuberth JM, Wukick DK, Andersen C, Vanore JV. Diabetic foot disorders: a clinical practice guideline. J Foot Ankle Surg 2006 Sep-Oct; 45(5):S2-66.
  22. HAYES Director of Medical Technology. Negative Pressure Wound Therapy for Wound Healing (07/03; updated 09/03/04).
  23. HAYES Directory of Medical Technology. Vacuum-assisted Closure for Wound Healing (06/98; 11/00).
  24. HAYES Update. Vacuum-assisted Closure for Wound Healing (VACU0601.06) (10/01/02).
  25. Hutton, D., Sheehan P. "Comparative Effectiveness of the SNaP Wound Care System." International Wound Journal. 8(2): 196-205.
  26. Infectious Diseases Society of America and the Surgical Infection Society 2011 Guidelines (endorsed) for the prevention of infections associated with combat-related injuries. Accessed 06/20/13.
  27. Institute for Clinical Systems Improvement (ICSI). Pressure ulcer prevention and treatment protocol. Health care protocol. Bloomington (MN): Institute for Clinical Systems Improvement (ICSI); 2012 Jan.
  28. Kenton D. Fong, MD; Dean Hu, MS; Shaundra L. Eichstadt, BS; Emily Gorell, MS; Claudia A. Munoz, MD, MPH; H. Peter Lorenz, MD; Anne Lynn S. Chang, MD. “Initial Clinical Experience Using a Novel Ultraportable Negative Pressure Wound Therapy Device”.
  29. Landsman A. Analysis of the SNaP Wound Care System, a Negative Pressure Wound Device for Treatment of Diabetic Lower Extremity Wounds. Diabetes Sci Technol. 4(4):831-832.
  30. Lee H, Kim J, Oh C, Min W, Shon O, et al. Negative Pressure Wound Therapy for Soft Tissue Injuries Around the Foot and Ankle. Journal of Orthopaedic Surgery and Research, 4(14) (October, 2009). Although there are multiple limitations to the study, to the evidence suggests that NPWT may be useful in the treatment of tendon and bone exposed wounds around the foot and ankle. The authors also felt that NPWT shortened healing time and reduced not only the chance of infection, but the need for additional soft tissue reconstruction as well.
  31. Lerman, B, H Oldendrook, et al. “Evaluation of Chronic Wound Treatment with the SNaP Wound Care System vs. Modern Dressing Protocols.” Plast Reconstr Surg 2010, 126:1153-1161.
  32. Lerman, B., L. Oldenbrook, et al. "The SNaP Wound Care System: a case series using a novel ultraportable negative pressure wound therapy device for the treatment of diabetic lower extremity wounds." J Diabetes Sci Technol, 4(4): 825-830; 2010.
  33. Lipsky BA, Berendt AR, Deery HG et al. Infectious Diseases Society of America. Diagnosis and Treatment of Diabetic Foot Infections. Clin Infect Dis. 2004 Oct 1;39(7):885-910. Available online at: http://www.idsociety.org/uploadedFiles/IDSA/Guidelines-Patient_Care/PDF_Library/Diabetic%20Foot%20Infection.pdf. Accessed 06/26/13.
  34. Wounds. 2010;22(9):230-36.
  35. Medicare Program Memorandum Transmittal B-00-43, (08/24/00).
  36. Medicare Region C DMERC, CGS Administrators LLC LCD #L5008 for Negative Pressure Wound Therapy Pumps (10/01/11).
  37. Medicare Region C DMERC, CGS Administrators LLC LCD #L5008 Article for Negative Pressure Wound Therapy Pumps (10/01/11)
  38. National Institute for Health and Clinical Excellence (NICE), Interventional procedure guidance 322. Negative pressure wound therapy for the open abdomen. Issue date: December 2009.
  39. Nemes K, Robertson R. Treatment of a diabetic hallux ulcer with ultraportable negative pressure wound therapy: a case study. Ostomy and Wound Mgmt. Published online 04/12/11.
  40. Rozen WM, Shahbaz S, Morsi A. An Improved Alternative to Vacuum-Assisted Closure (VAC) as a Negative Pressure Dressing in Lower Limb Split Skin Grafting: A Clinical trial. Journal of Plastic, Reconstructive and Aesthetic Surgery, 61, 334-337 (Jan 2010). Several articles have investigated the benefits of commercial wound VAC systems. One limiting factor of this commercial modality is cost. While a closed suction system as described in this article may not be appropriate or beneficial in larger wounds, it may be a relatively inexpensive alternative dressing option.
  41. Samson DJ, Lefevre F, Aronson N. Wound-healing technologies: low-level laser and vacuum-assisted closure. Evidence Report/Technology Assessment No. 111. (Prepared by the Blue Cross and Blue Shield Association Technology Evaluation Center Evidence-based Practice Center, under Contract No. 290-02-0026.) AHRQ Publication No. 05-E005-2. Rockville, MD: Agency for Healthcare Research and Quality (12/04).
  42. U.S. Food and Drug Administration (FDA) Preliminary Public Health Notification: Serious Complications Associated with Negative Pressure Wound Therapy Systems (11/13/09).
  43. U.S. Food and Drug Administration (FDA) Safety Communication: Update on Serious Complications Associated with Negative Pressure Wound Therapy Systems (02/24/11).
  44. U.S. Food and Drug Administration. FDA's MedWatch Safety Alerts: Negative Pressure Wound Therapy (NPWT) Devices (02/24/11).

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 07/24/14.

GUIDELINE UPDATE INFORMATION:

04/15/01

New Medical Coverage Guideline.

04/15/03

Reviewed; no changes in coverage statement.

01/01/04

Annual HCPCS coding update.

04/15/05

Scheduled review: no change in coverage statement; reimbursement information updated to reflect DME contracted fee schedule agreement.

01/01/06

Annual HCPCS coding update: revise A6550, and remove A6551.

04/15/07

Scheduled review; no change in coverage statement; reimbursement statement revised for clarification; A6550 deleted; references updated.

06/15/07

Reformatted guideline.

05/15/09

Scheduled review: added reimbursement statement regarding multiple pumps; re-named guideline; added Program Exception information for Medicare Advantage; updated references.

08/15/10

Position Statement unchanged; coding section updated; Program Exception section updated; references updated.

02/01/11

Revision; formatting changes.

07/01/11

3rd Quarter HCPCS coding update: added codes K0743 – K0746.

07/15/11

Revision; formatting changes.

09/15/11

Revision; formatting changes.

11/15/11

Review and revision; Position Statement updated to include information for non-electric NPWT pumps; references updated; formatting changes.

01/01/12

Annual HCPCS coding update: added A9272.

08/15/12

Revision to add position statement regarding single-use NPWT devices; revision of Reimbursement section; references updated; formatting changes.

01/01/13

Annual HCPCS coding update: added G0456 and G0457.

08/15/13

Scheduled review: Position Statement unchanged; Program Exceptions section updated; references updated.

01/01/14

Annual HCPCS coding updated: revised descriptor for A9272.

08/15/14

Scheduled review: position statement revised for clarification of criteria; references updated.

01/01/15

Annual coding update. Revised 97605 and 97606; added 97607 and 97608; deleted G0456 and G0457.

11/01/15

Revision: ICD-9 Codes deleted.

Date Printed: June 23, 2017: 06:20 PM