HumanaCommercial Clinical Policy

Humana Negative Pressure Wound Therapy - Medicare Advantage Form


Negative Pressure Wound Therapy

Notes: Services that do not meet the criteria above are not medically necessary and thus do not provide a clinical benefit. Medically unnecessary services carry risks of adverse outcomes and may interfere with the pursuit of other treatments which have demonstrated efficacy.

Indications

(300656) Is the wound chronic and non-healing with a lack of improvement despite standard wound therapy? 
(300657) Is the wound one of the following types: acute wound, subacute and dehisced wound, traumatic wound, ulcer (diabetic or pressure), chronic Stage III or IV pressure ulcer, chronic diabetic neuropathic ulcer, chronic venous ulcer, flap or graft, or complication of a surgically created wound? 
(300658) Is there a need for accelerated formation of granulation tissue not achievable by other topical wound treatments? 
(300659) For continuation of NPWT, is there documented improvement in wound measurements (volume or surface dimension) with NPWT treatment? 

Contraindications

(300660) Does the wound have any of the following contraindications: Exposed vital organs, fistulas to organs or body cavities, malignancy in the wound, necrotic tissue with eschar, placement over exposed arteries or veins, placement over exposed nerves, presence of exposed anastomotic sites, or untreated osteomyelitis? 
Effective Date

01/01/2024

Last Reviewed

NA

Original Document

  Reference



Please refer to CMS website for the most current applicable National Coverage Determination (NCD)/ Local Coverage Determination (LCD)/Local Coverage Article (LCA)/CMS Online Manual System/ Transmittals.

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Type

Title

ID Number

Jurisdiction Medicare Administrative Contractors (MACs)

Applicable States/Territories

  • LCD LCA
  • Wound Care Billing and Coding: Wound Care |
  • 137228
  • Physicians Service Insurance Corporation
  • IA, KS, MO, NE IN, MI
  • a55909 -
  • J8 - Wisconsin Physicians Service Insurance Corporation
  • LCD LCA
  • Wound and Ulcer Care Billing and Coding: Wound and Ulcer Care
  • L38902 - A58565 -
  • JE - Noridian Healthcare Solutions, LLC
  • CA, HI, NV, American Samoa, Guam, Northern Mariana Islands
  • LCD LCA
  • Wound and Ulcer Care Billing and Coding: Wound and Ulcer Care
  • L38904 A58567 -
  • JE - Noridian Healthcare Solutions, LLC
  • AK, AZ, ID, MT, ND, OR, SD, UT, WA, WY
  • LCD LCA Lcp
  • Wound Care
  • L35125
  • JH - Novitas Solutions, Inc. (Part A/B MAC)
  • AR, CO, NM, OK, TX, LA, MS
  • Billing and Coding: Wound Care
  • A53001
  • JL - Novitas
  • DE, D.C., MD, NJ, PA
  • Wound Care
  • L37166
  • Solutions, Inc. (Part A/B MAC) JN - First Coast
  • LCA tcp LCA
  • Billing and Coding: Wound Care |
  • A55818
  • Service Options, Inc. (Part A/B MAC) DME A - Noridian
  • FL, PR, U.S. VI CT, DE, DC, ME, MD,
  • Negative Pressure Wound Therapy Pumps Negative Pressure Wound Therapy Pumps - Policy Article
  • Healthcare Solutions, LLC (DME MAC)
  • MA, NH, NJ, NY, PA, RI, VT IL, IN, KY, MI, MN,
  • 133821
  • DME B - CGS Administrators, LLC (DME MAC)
  • OH, WI AL, AR, CO, FL, GA,
  • LA, MS, NM, NC, OK,
  • A52511
  • DME C- CGS Administrators, LLC
  • SC, TN, TX, VA, WV, PR, U.S. VI

DME D - Noridian Healthcare Solutions, LLC (DME MAC) AK, AZ, CA, HI, ID, IA, KS, MO, MT, NE, NV, ND, OR, SD, UT, WA, WY, American Samoa, Guam, Negative Pressure Wound Therapy Page: 3 of 15

Description

Negative pressure wound therapy (NPWT), also called vacuum assisted wound closure, refers to wound dressing systems that continuously or intermittently apply subatmospheric pressure to the surface of a wound. NPWT is most commonly used in the treatment of acute and chronic wounds such as surgical wounds, various soft tissue injuries or ulcers (eg, diabetic foot, pressure and venous leg). This technique may also be prescribed to promote healing prior to using a flap or skin graft by advancing early healing of the site, thereby preparing the wound bed for surgical reconstruction.

NPWT involves the application of a localized vacuum to the wound surface to draw the edges of the wound together. NPWT devices are available as rental (portable) or disposable (single-use) units.

The NPWT device consists of a dressing of gauze and/or open-celled reticulated foam that is placed in the wound. A tube is embedded into the dressing and sealed with an adhesive transparent dressing. Attached to the tube is a vacuum pump which applies negative pressure to the wound. This pressure drains fluid and exudates from the wound to a disposable canister.

The intent of this treatment is to help reduce edema, improve vascularity and oxygenation of the wound bed, provide a moist environment and help stimulate healthy granulation tissue conducive to rapid wound healing.

Negative pressure wound therapy placement over surgically closed incisions is an alternative to absorbent dressings, gauze and adhesive medical tape (eg, npSIMS, Prevena, Prevena Duo and Prevena Restor Incision Management System). Purportedly intended to promote healing by holding incision sides closed, removing fluid and reducing the incidence of seromas and surgical site infections.

Negative pressure wound therapy with instillation (NPWTi) is the combination of NPWT with timed, intermittent delivery of a topical solution. The fluid reportedly helps to remove wound exudate, slough and bacteria to purportedly promote more rapid healing of the wound. The solution is delivered and remains in the wound for a set amount of time and subsequently removed via NPWT.

Coverage Determination

Humana follows the CMS requirements that only allows coverage and payment for services that are reasonable and necessary for the diagnosis and treatment of illness or injury or to improve the functioning of a malformed body member except as specifically allowed by Medicare.

Please refer to the above Medicare guidance for negative pressure wound therapy (NPWT) device.

In interpreting or supplementing the criteria above and in order to determine medical necessity consistently, Humana may consider the following criteria:

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Negative pressure wound therapy, or NPWT, (codes 97605-97608) will be considered medically reasonable and necessary when one of the following indications is met12,13:

  • Chronic, non-healing ulcer with lack of improvement despite standard wound therapy which includes: applications of dressings, adequate blood glucose control, debridement of necrotic tissue (if present), maintenance of an adequate nutritional status, offloading, and weekly evaluations with documentation of wound measurements (i.e. length, width, and depth) in one of the following clinical situations:
    • Acute wounds; OR
    • Subacute and dehisced wounds; OR
    • Traumatic wounds; OR
    • Ulcers (such as diabetic or pressure); OR
    • Chronic Stage III or IV pressure ulcers; OR
    • Chronic diabetic neuropathic ulcer; OR
    • Chronic venous ulcer; OR
    • Flaps and grafts; OR
  • Complications of a surgically created wound (e.g., dehiscence, post sternotomy disunion with exposed sternal bone, post sternotomy mediastinitis, or postoperative disunion of the abdominal wall); OR
  • Traumatic wound (preoperative flap or graft, exposed bones, tendons, or vessels) and a need for accelerated formation of granulation tissue not achievable by other topical wound treatments (the individual has comorbidities that will not allow for healing times usually achievable with other available topic wound treatments).

Continuation of NPWT treatment for an additional 30 days for the treatment of wounds will be considered medically reasonable and necessary when documentation is provided by an appropriate licensed medical professional and ALL of the following criteria are met:

  • There is improvement in the wound measurements (volume or surface dimension) with NPWT treatment

The use of the criteria in this Medicare Advantage Medical Coverage Policy provides clinical benefits highly likely to outweigh any clinical harms. Services that do not meet the criteria above are not medically necessary and thus do not provide a clinical benefit. Medically unnecessary services carry risks of adverse outcomes and may interfere with the pursuit of other treatments which have demonstrated efficacy.

Coverage Limitations

US Government Publishing Office.

Electronic code of federal regulations: part 411 – 42 CFR § 411.15 - Particular services excluded from coverage

NPWT devices will not be considered medically reasonable and necessary for wounds that have responded to standard therapeutic measures OR for individuals with the following contraindications12,13,54:

  • Exposed vital organs; OR
  • Fistulas to organs or body cavities; OR

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  • Malignancy in the wound; OR
  • Necrotic tissue with eschar; OR
  • Placement over exposed arteries or veins; OR
  • Placement over exposed nerves; OR
  • Presence of exposed anastomotic sites (located at the site of the surgical connection of two tubular structures); OR
  • Untreated osteomyelitis