Negative Pressure Wound Therapy in the Outpatient Setting
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This policy governs when initiation and continuation of powered NPWT in the outpatient setting are considered medically necessary or investigational for Capital Bluecross members; it applies to clinicians and prior authorization reviewers involved in outpatient wound care.
Updated criteria including but not limited to single use devices are now INV and chronic being defined in this policy as greater than 90 days; Procedure codes 97607 and 97608 have been moved to INV coding table.
Added/deleted ICD-10 codes from New Code Process effective 10/01/2024.
Changed frequency of monitoring from every 14 days to monthly.
Coverage Criteria for Outpatient Powered NPWT
Initial Therapy
An initial therapeutic trial of not less than 2 weeks using a powered NPWT system may be considered medically necessary when ANY ONE of the following indications is met:
Part of a comprehensive wound care program addressing modifiable factors (eg, diabetes control, nutrition, pressure relief)
Malnutrition must be addressed simultaneously with NPWT; part of a comprehensive wound care program
Requires exposed structures or foreign material and inclusion in comprehensive wound care program
Continuation Therapy
Continuation of powered NPWT may be considered medically necessary after an initial 2-week therapeutic trial if ALL of the following are met:
Objective improvements include development/presence of healthy granulation tissue, progressive wound contracture/decreasing depth, and/or commencement of epithelial spread
Monitor wound healing at least every 14 days and document objective measures to support continued therapy
Investigational Continuation Criteria
Continuation is considered investigational (not supported) when ANY of the following occur:
Absence of documented objective improvement makes continuation investigational
Includes wound complications that make NPWT unsafe or inappropriate
When healing eliminates the need for NPWT, continuation is investigational/not supported
Initial NPWT therapeutic trial criteria
Covered when ALL of the following are met:
Objective evidence of healing is required for continuation beyond the trial period
Continuation criteria
Covered for continued use when ALL of the following are met:
Providers must monitor and document objective improvements at least every 14 days as part of a comprehensive wound care program; lack of objective improvement may render continued therapy not medically necessary
Contraindications to the use of negative pressure wound therapy (NPWT) include conditions noted by the U.S. Food and Drug Administration: necrotic tissue with eschar, untreated osteomyelitis, nonenteric and unexplored fistulae, malignancy in the wound, exposed nerve, exposed anastomotic site, and exposed organ. The FDA has also reported serious but rare adverse events, most notably bleeding, and infections related to retained dressing pieces; providers should select patients carefully, monitor frequently, and be prepared to intervene promptly for complications. The FDA additionally noted that the safety and effectiveness of NPWT systems have not been established for newborns, infants, and children (no NPWT systems cleared for these populations). Continuation of healing during NPWT should be monitored at a frequency of not less than every 14 days, and complete healing is generally anticipated when bone/cartilage/tendon/foreign material are covered, healthy granulation approaches within 5 mm of the surface, and wound edges are reduced to about 2 cm.
The policy designates certain procedure codes as investigational and not covered. Specifically, Procedure Codes A9272 and 97607 are listed as investigational and therefore are not covered.
This document is an excerpt of the outpatient Negative Pressure Wound Therapy policy. Claims and coverage determinations for outpatient NPWT should be evaluated in reference to Policy Number MP 4.004 (Negative Pressure Wound Therapy in the Outpatient Setting); providers should follow that full policy for detailed coverage, coding, and prior-authorization requirements.
No explicit additional exclusion list is included in the provided excerpt beyond the contraindications noted; the excerpt indicates that comprehensive coverage determinations should refer to the full outpatient NPWT policy (MP 4.004). Policy history in the excerpt documents a consensus review (04/23/2020) but does not add further exclusion conditions in this portion.
Therapeutic trials of powered NPWT systems for treatment of other acute or chronic wounds not specifically listed in the policy are considered investigational. Use of single-use NPWT systems (powered or nonpowered) for acute or chronic wounds, including but not limited to diabetic, venous, surgical, and traumatic wounds, is considered investigational.
The evidence base supporting outpatient NPWT for the listed indications consists primarily of randomized controlled trials and systematic reviews; however, these trials are generally low quality and at high risk of bias, with many studies conducted in inpatient settings or limited by small sample sizes, losses to follow-up, or short-term outcomes. Overall, the available RCTs and systematic reviews provide insufficient high-quality evidence to conclusively demonstrate improved net health outcomes for many outpatient indications.
Within the provided excerpt there is no explicit statement using the phrase ‘not medically necessary’ for specific indications. The excerpt does, however, state investigational stances for therapies and devices not supported by evidence and refers readers to the full outpatient NPWT policy (MP 4.004) for complete determinations.
Coding — Procedure, Supply, and Diagnosis Codes
| FDA product code: OMP | FDA product classification code for NPWT devices |
| E08.621 | Diabetes mellitus due to underlying condition with foot ulcer |
| E08.622 | Diabetes mellitus due to underlying condition with other skin ulcer |
| E09.621 | Drug or chemical induced diabetes mellitus with foot ulcer |
| E09.622 | Drug or chemical induced diabetes mellitus with other skin ulcer |
| E10.621 | Type 1 diabetes mellitus with foot ulcer |
| E10.622 | Type 1 diabetes mellitus with other skin ulcer |
| E11.621 | Type 2 diabetes mellitus with foot ulcer |
| E11.622 | Type 2 diabetes mellitus with other skin ulcer |
| E11.A | Type 2 diabetes mellitus without complications in remission |
| E13.621 | Other specified diabetes mellitus with foot ulcer |
| I70.643 | Atherosclerosis of nonbiological bypass graft(s) of the left leg with ulceration of ankle |
| I70.644 | Atherosclerosis of nonbiological bypass graft(s) of the left leg with ulceration of heel and midfoot |
| I70.645 | Atherosclerosis of nonbiological bypass graft(s) of the left leg with ulceration of other part of foot |
| I70.648 | Atherosclerosis of nonbiological bypass graft(s) of the left leg with ulceration of other part of lower leg |
| I70.65 | Atherosclerosis of nonbiological bypass graft(s) of other extremity with ulceration |
| I70.731 | Atherosclerosis of other type of bypass graft(s) of the right leg with ulceration of thigh |
| I70.732 | Atherosclerosis of other type of bypass graft(s) of the right leg with ulceration of calf |
| I70.733 | Atherosclerosis of other type of bypass graft(s) of the right leg with ulceration of ankle |
| I70.734 | Atherosclerosis of other type of bypass graft(s) of the right leg with ulceration of heel and midfoot |
| I70.735 | Atherosclerosis of other type of bypass graft(s) of the right leg with ulceration of other part of foot |
| I83.011 | Varicose veins of right lower extremity with ulcer of thigh |
| I83.012 | Varicose veins of right lower extremity with ulcer of calf |
| I83.013 | Varicose veins of right lower extremity with ulcer of ankle |
| I83.014 | Varicose veins of right lower extremity with ulcer of heel and midfoot |
| I83.015 | Varicose veins of right lower extremity with ulcer other part of foot |
| I83.018 | Varicose veins of right lower extremity with ulcer other part of lower leg |
| I83.021 | Varicose veins of left lower extremity with ulcer of thigh |
| I83.022 | Varicose veins of left lower extremity with ulcer of calf |
| I83.023 | Varicose veins of left lower extremity with ulcer of ankle |
| L89.003 | Pressure ulcer of unspecified elbow, stage 3 |
| L89.004 | Pressure ulcer of unspecified elbow, stage 4 |
| L89.013 | Pressure ulcer of right elbow, stage 3 |
| L89.014 | Pressure ulcer of right elbow, stage 4 |
| L89.023 | Pressure ulcer of left elbow, stage 3 |
| L89.024 | Pressure ulcer of left elbow, stage 4 |
| L89.103 | Pressure ulcer of unspecified part of back, stage 3 |
| L89.104 | Pressure ulcer of unspecified part of back, stage 4 |
| L89.113 | Pressure ulcer of right upper back, stage 3 |
| L97.111 | Non-pressure chronic ulcer of right thigh limited to breakdown of skin |
| L97.112 | Non-pressure chronic ulcer of right thigh with fat layer exposed |
| L97.113 | Non-pressure chronic ulcer of right thigh with necrosis of muscle |
| L97.114 | Non-pressure chronic ulcer of right thigh with necrosis of bone |
| L97.115 | Non-pressure chronic ulcer of right thigh with muscle involvement without evidence of necrosis |
| L97.211 | Non-pressure chronic ulcer of right calf limited to breakdown of skin |
| L97.312 | Non-pressure chronic ulcer of right ankle with fat layer exposed |
| L97.313 | Non-pressure chronic ulcer of right ankle with necrosis of muscle |
| L97.314 | Non-pressure chronic ulcer of right ankle with necrosis of bone |
| L98.411 | Non-pressure chronic ulcer of buttock limited to breakdown of skin |
| L98.412 | Non-pressure chronic ulcer of buttock with fat layer exposed |
| L98.414 | Non-pressure chronic ulcer of buttock with necrosis of bone |
| L98.423 | Non-pressure chronic ulcer of back with necrosis of muscle |
| L98.43 | Non-pressure chronic ulcer of abdomen |
| L98.A11 | Non-pressure chronic ulcer of right upper arm (examples of L98.A* series present) |
| L98.45 | Non-pressure chronic ulcer of neck |
| L98.46 | Non-pressure chronic ulcer of face |
| L98.47 | Non-pressure chronic ulcer of groin |
| L98.491 | Non-pressure chronic ulcer of skin of other sites limited to breakdown of skin |
| L98.492 | Non-pressure chronic ulcer of skin of other sites with fat layer exposed |
| L98.493 | Non-pressure chronic ulcer of skin of other sites with necrosis of muscle |
| L98.494 | Non-pressure chronic ulcer of skin of other sites with necrosis of bone |
| L98.495 | Non-pressure chronic ulcer of skin of other sites with muscle involvement without evidence of necrosis |
| L98.498 | Non-pressure chronic ulcer of skin of other sites with other specified severity |
| L98.A | Non-pressure chronic ulcer of upper limb, not elsewhere classified |
| S31.101D | Unspecified open wound of abdominal wall, left upper quadrant without penetration into peritoneal cavity, subsequent encounter |
| S31.101S | Unspecified open wound of abdominal wall, left upper quadrant without penetration into peritoneal cavity, sequela |
| S31.102D | Unspecified open wound of abdominal wall, epigastric region without penetration into peritoneal cavity, subsequent encounter |
| S31.102S | Unspecified open wound of abdominal wall, epigastric region without penetration into peritoneal cavity, sequela |
| S31.103D | Unspecified open wound of abdominal wall, right lower quadrant without penetration into peritoneal cavity, subsequent encounter |
| S31.103S | Unspecified open wound of abdominal wall, right lower quadrant without penetration into peritoneal cavity, sequela |
| S31.104D | Unspecified open wound of abdominal wall, left lower quadrant without penetration into peritoneal cavity, subsequent encounter |
| S31.104S | Unspecified open wound of abdominal wall, left lower quadrant without penetration into peritoneal cavity, sequela |
| S31.105D | Unspecified open wound of abdominal wall, periumbilic region without penetration into peritoneal cavity, subsequent encounter |
| S31.105S | Unspecified open wound of abdominal wall, periumbilic region without penetration into peritoneal cavity, sequela |
| S31.116A | Laceration without foreign body of abdominal wall, right flank without penetration into peritoneal cavity, initial encounter |
| S31.116D | Laceration without foreign body of abdominal wall, right flank without penetration into peritoneal cavity, subsequent encounter |
| S31.116S | Laceration without foreign body of abdominal wall, right flank without penetration into peritoneal cavity, sequela |
| S31.117A | Laceration without foreign body of abdominal wall, left flank without penetration into peritoneal cavity, initial encounter |
| S31.117D | Laceration without foreign body of abdominal wall, left flank without penetration into peritoneal cavity, subsequent encounter |
| S31.117S | Laceration without foreign body of abdominal wall, left flank without penetration into peritoneal cavity, sequela |
| S31.126A | Laceration with foreign body of abdominal wall, right flank without penetration into peritoneal cavity, initial encounter |
| S31.126D | Laceration with foreign body of abdominal wall, right flank without penetration into peritoneal cavity, subsequent encounter |
| S31.126S | Laceration with foreign body of abdominal wall, right flank without penetration into peritoneal cavity, sequela |
| S31.127A | Laceration with foreign body of abdominal wall, left flank without penetration into peritoneal cavity, initial encounter |
| S31.136A | Puncture wound of abdominal wall without foreign body, right flank without penetration into peritoneal cavity, initial encounter |
| S31.136D | Puncture wound of abdominal wall without foreign body, right flank without penetration into peritoneal cavity, subsequent encounter |
| S31.137A | Puncture wound of abdominal wall without foreign body, left flank without penetration into peritoneal cavity, initial encounter |
| S31.137D | Puncture wound of abdominal wall without foreign body, left flank without penetration into peritoneal cavity, subsequent encounter |
| S31.13AA | Puncture wound of abdominal wall without foreign body, unspecified flank without penetration into peritoneal cavity, initial encounter |
| T81.31XA | Disruption of external operation (surgical) wound, initial encounter |
| T81.31XD | Disruption of external operation (surgical) wound, subsequent encounter |
| T81.320A | Disruption or dehiscence of gastrointestinal tract anastomosis, repair, or closure, initial encounter |
| T81.320D | Disruption or dehiscence of gastrointestinal tract anastomosis, repair, or closure, subsequent encounter |
| T81.320S | Disruption or dehiscence of gastrointestinal tract anastomosis, repair, or closure, sequela |
| T81.328S | Disruption or dehiscence of closure of other specified internal operation (surgical) wound, sequela |
| T81.329A | Deep disruption or dehiscence of operation wound, unspecified, initial encounter |
| T81.329D | Deep disruption or dehiscence of operation wound, unspecified, subsequent encounter |
| T81.329S | Deep disruption or dehiscence of operation wound, unspecified, sequela |
| T81.33XA | Disruption of traumatic injury wound repair, initial encounter |
| T81.33XD | Disruption of traumatic injury wound repair, subsequent encounter |
| T81.42XA | Infection following a procedure, deep incisional surgical site, initial encounter |
| T81.42XD | Infection following a procedure, deep incisional surgical site, subsequent encounter |
| T81.49XA | Infection following a procedure, other surgical site, initial encounter |
Provider Actions, Prior Authorization, and Documentation Requirements
Prior authorization requirement: initial ≥2‑week trial; continuation needs documentation
An initial therapeutic trial of powered NPWT of not less than 2 weeks is required for initiation; continuation beyond this initial 2‑week trial requires documented objective improvement in the wound (see continuation criteria).
- Initial trial duration: not less than 2 weeks (>=14 days).
- Continuation requires documentation of objective improvements (granulation tissue, progressive wound contracture/decreasing depth, or epithelial spread).
Coverage and investigational code summary; follow coding table
Use the policy's coding tables: certain HCPCS/CPT procedure and supply codes are designated investigational/not covered (e.g., A9272, 97607) while others are listed as covered when medically necessary (e.g., 97606, A7000/A7001, E2402, K0743–K0746, 97605). Prior authorization and billing must follow the coding table classifications in the policy.
Follow outpatient NPWT policy MP 4.004 for adjudication
Adjudication and any prior authorization determinations should follow the full outpatient NPWT policy (Policy Number MP 4.004); this excerpt cross-references that policy for complete clinical rules and coverage logic.
- Policy reference: POLICY NUMBER MP 4.004 (Negative Pressure Wound Therapy in the Outpatient Setting).
Prior authorization — consult full policy for PA steps/forms
This excerpt does not state the complete prior authorization process or specific forms; providers must consult the full MP 4.004 policy and payer prior‑authorization resources for explicit PA steps and required documentation.
- Full prior authorization steps and forms are in the complete policy and payer PA guidance (not included in this excerpt).
Adjunctive care requirement: NPWT as part of comprehensive wound care
Powered NPWT must be used as part of a comprehensive wound care program that addresses modifiable factors such as diabetes control, nutritional status, and relief of pressure; documentation should show these adjunctive measures were considered and managed.
- Comprehensive wound care includes evaluation and wound measurements by a licensed medical professional, dressings to maintain a moist environment, debridement when present, and evaluation/provision for nutrition and vascular status.
- Examples of modifiable factors: diabetes control, nutrition, pressure relief.
Prior conservative therapy requirement: conventional care ≥30 days before NPWT trial
For chronic wounds, a therapeutic trial of intense conventional wound therapy for at least 30 days is expected before considering NPWT; NPWT may then be trialed for not less than 14 days if the wound has failed to heal despite prior care.
- Prior conservative therapy: intense conventional wound therapy ≥30 days for chronic wounds that have failed to heal.
- Therapeutic trial of NPWT thereafter: not less than 14 days.
Placeholder — consult full document where inventory is empty
This callout is a placeholder referencing inventory entries with no chunk indices; consult the full policy source (MP 4.004) for any additional provider actions not captured in this excerpt.
- Fallback: review the complete policy document for missing details.
Step therapy absence in excerpt
No step therapy requirements are specified in this excerpt of the policy.
- The excerpt explicitly notes that no step therapy requirements are specified here.
Placeholder — additional policy details in full document
This callout is a placeholder for inventory entries lacking excerpt content; providers should reference the full MP 4.004 policy when preparing prior authorization or appeals.
- Use the full policy for comprehensive requirements and examples.
Required clinical documentation and monitoring: objective improvements after initial 2‑week trial
Providers must document objective improvements after the initial 2‑week therapeutic trial and monitor healing at least every 14 days (unless otherwise specified in payer guidance); objective signs include healthy granulation tissue, progressive wound contracture/decreasing depth, and epithelial spread.
- Monitoring frequency: continuation of healing should be monitored not less than every 14 days.
- Objective improvement examples: development/presence of healthy granulation tissue, progressive wound contracture/decreasing depth, commencement of epithelial spread.
Comprehensive wound care documentation required
Document a licensed medical professional's evaluation, wound measurements, dressing application, and any debridement performed; include nutrition and vascular status assessments as part of the comprehensive wound care record.
- Minimum documentation elements: licensed clinician evaluation, wound measurements, dressing details, debridement records, and nutritional/vascular assessments.
Objective healing documentation required for continuation
Record objective evidence of response to therapy—such as healthy granulation tissue formation and progressive wound contracture—to justify continued NPWT beyond the initial therapeutic trial.
- Objective healing documentation is required for continued coverage beyond 14 days.
Diagnosis code list for documentation: reference I70.*, I83.*, I87.*, L89.*, L97.*, L98.*
Include appropriate ICD-10 diagnosis codes when submitting documentation and claims; the policy lists code blocks such as I70.*, I83.*, I87.*, L89.*, L97.*, and L98.* that correspond to vascular, venous, pressure, and non‑pressure chronic ulcer diagnoses.
- Diagnosis code groups referenced: I70.* (vascular ulcers), I83.* (varicose/venous ulcers), I87.*, L89.*, L97.*, L98.*.
Extensive ICD‑10 code list included — reference codes like L98.*, S31.*, T81.*
The policy contains an extensive ICD-10 list (including L98.* series, S31.* and T81.* codes) that should be used to support documentation and claims for NPWT initiation and continuation in the outpatient setting.
- Examples include L98.* series (other non‑pressure chronic ulcers), S31.* (open wounds of abdominal wall), and T81.* (surgical wound disruptions/infections).
Administrative ICD‑10 update effective 10/01/2024 — use current codes
Policy history documents administrative ICD‑10 code updates effective 10/01/2024; ensure current diagnosis codes are used on claims and supporting documentation.
- 08/15/2024 Administrative Update: Added/deleted ICD‑10 codes from New Code Process; effective date 10/01/2024.
Triggers for denial of continuation: lack of documented objective improvement or contraindicating complications
Continuation may be denied (considered investigational) when the therapeutic trial or subsequent treatment period has not produced documented objective improvement, when complications contraindicate continued NPWT, or when the wound has healed sufficiently for grafting or alternative treatments.
- Trigger examples for denial: lack of documented objective improvement; wound complications that contraindicate NPWT; wound healed to permit grafting or other care.
Requirement for continued coverage: objective evidence of healing beyond 14 days
For continued coverage beyond the 14‑day trial, providers must supply objective evidence of wound healing (e.g., healthy granulation tissue, progressive wound contracture); absence of these findings may render continued NPWT not medically necessary.
- Required evidence: development of healthy granulation tissue and progressive wound contracture during continued treatment.
Policy reference: claims evaluated against MP 4.004
Claims and coverage decisions may be evaluated against Policy Number MP 4.004 (Negative Pressure Wound Therapy in the Outpatient Setting); reference this policy number in PA submissions and appeals.
- Policy reference to include on submissions: MP 4.004.
Diagnostic coding mismatch risk: ensure codes match listed ICD‑10 diagnoses
Diagnostic codes that do not match the policy's listed ICD‑10 codes or clinical documentation that lacks a supported wound diagnosis may trigger claim denial; ensure the diagnosis and supporting records align with the codes enumerated in the policy.
- Mismatch risk: using diagnosis codes not listed (or failing to document a supported wound diagnosis) may lead to denial.
Coding change denial risk: 97607/97608 reclassification may affect adjudication
Changes to coding (for example, moving procedure codes 97607 and 97608 to the investigational table) can affect claim adjudication and may trigger denials if billing teams use outdated code tables; notify billing teams of these reclassifications.
Background and Evidence Summary
Negative pressure wound therapy (NPWT) is a wound treatment modality that applies controlled suction to remove fluid, debris, and infectious material from a wound bed to promote granulation tissue formation and wound contraction. The mechanism is thought to include removal of interstitial fluid and reduction of edema, increased local blood flow and vascularity, and mechanical forces that may stimulate cellular proliferation and tissue growth. NPWT may be used adjunctively to surgery or as an alternative for patients who are not surgical candidates; both powered/electrically driven devices and portable single-use mechanical systems are described in the policy.
The evidence base for outpatient NPWT is characterized by randomized trials and systematic reviews but is generally judged to be of low quality with high risk of bias. For chronic pressure ulcers and for lower-extremity venous ulcers, trials have been small, often conducted in inpatient settings, and have not provided consistent high-quality evidence of improved long-term outcomes such as complete wound closure. Studies of portable single-use devices have shown noninferiority for wound-area reduction in some trials, but limitations including loss to follow-up, lack of appropriate control groups, and limited outpatient data mean that the evidence remains insufficient to draw firm conclusions about net clinical benefit in the outpatient setting.
Definitions and Device Types
Policy Revision History
Added ICD-10 codes via administrative update.
Removed Benefit Variations section and updated Disclaimer.
Minor review updated criteria including reclassification of single-use devices to investigational and defined 'chronic' as greater than 90 days; procedure codes 97607 and 97608 moved to the investigational coding table.
Administrative update adding and deleting ICD-10 codes from the New Code Process effective 10/01/2024.
Consensus review updated cross-references, background, rationale, and references with no changes to coding.
Consensus review updated description/background, coding table, and references.
Consensus review updated the summary of evidence, FEP, and references with no changes to policy statement.
Minor review changed monitoring frequency from every 14 days to monthly and removed Length of Coverage section; no changes to coding.
Consensus review; policy statements remained unchanged as noted in policy history.
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