Protect Access to Near-Infrared Wound Assessment
Patients with hard-to-heal wounds need care based on the best available evidence. Near-infrared spectroscopy (NIRS) provides information about tissue oxygen levels that can help clinicians evaluate treatment response, identify barriers to healing, and determine when to adjust care.
Join the Wound and Hyperbaric Association in urging Medicare Administrative Contractors to withdraw the proposed blanket noncoverage policies for NIRS, preserve existing coverage where applicable, and develop an evidence-based coverage framework with input from clinicians, patients, and other stakeholders.
Add your voice to support medically necessary access to NIRS. Please use the custom message box to include details about your unique experience or reference the proposed LCD number mentioned below. Note: This NIRS action addresses proposed policies from CGS, NGS / Wellpoint Federal, Noridian, Palmetto, and WPS. Corresponding NIRS proposals have not been identified for First Coast or Novitas.
Recipient MACs, proposed LCD numbers, and CMS links:
<ul>
<li>CGS <a href="https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=40465&" target="_blank">DL40466</a>&nbsp;</li>
<li>NGS / Wellpoint Federal <a href="https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=40476&ver=10&" target="_blank">DL40477</a>&nbsp;</li>
<li>Noridian <a href="https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=40457&ver=3" target="_blank">DL40458</a>&nbsp;</li>
<li>Palmetto <a href="https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=40452&ver=7&" target="_blank">DL39385</a>&nbsp;</li>
<li>WPS <a href="https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=40478&ver=3&" target="_blank">DL40479</a>&nbsp;</li>
</ul>

Request for Withdrawal of the Proposed Noncoverage LCD for Near-Infrared Spectroscopy

The proposed LCD, Near-Infrared Spectroscopy (NIRS) in Wound and Flap Management, represents a deeply concerning departure from the growing emphasis on objective evaluation, treatment modification, and evidence-informed clinical decision-making in modern wound care. We believe the proposal raises significant concerns regarding patient access to care and the ability of clinicians to obtain objective diagnostic information regarding tissue oxygenation, which supports evaluation of the plan of care, treatment modification, referral decisions, and ongoing patient management.

We respectfully urge the Medicare Administrative Contractors to:

-Withdraw the proposed noncoverage LCD addressing Near-Infrared Spectroscopy (NIRS);

-Maintain current existing coverage where applicable and establish contractor pricing across all MACs; and

-Develop an evidence-based framework in collaboration with clinicians, providers, professional societies, manufacturers, and other stakeholders for the appropriate use of objective technologies that support reevaluation of the plan of care and clinical decision-making in wound care.

For patients with hard-to-heal wounds, timely recognition of treatment response, lack of progress, or clinical deterioration can have significant implications for healing, infection risk, hospitalization, limb preservation, and overall outcomes. Modern wound care therefore requires clinicians to reevaluate treatment effectiveness, modify plans of care, identify treatment failure, and make appropriate decisions regarding referral, escalation of care, and resource utilization.

These responsibilities are not only clinical realities but increasingly explicit expectations within wound care policy.

Adequate tissue oxygenation is a fundamental requirement for wound healing, and changes in tissue oxygenation provide important diagnostic information regarding treatment response and healing potential. As expectations to evaluate treatment effectiveness and appropriately modify the plan of care continue to increase, clinicians require access to objective tools that help them accomplish these goals.

Objective physiologic information informs clinical decision-making; evidence supports a targeted coverage approach

NIRS is not intended to directly heal wounds. Rather, it provides objective physiologic information regarding tissue oxygenation that clinicians use to evaluate treatment response, identify potential perfusion-related barriers to healing, support referral decisions, and determine whether modification of the plan of care is warranted. Its value lies in the clinical decisions informed by this information.

Published evidence demonstrates that NIRS can identify tissue compromise before clinical deterioration becomes apparent. Multiple systematic reviews evaluating flap monitoring have reported earlier detection of vascular compromise and improved flap salvage rates when NIRS is incorporated into postoperative monitoring protocols. [1–4] In addition, prospective clinical studies have demonstrated that intraoperative tissue oxygenation measurements correlate with subsequent skin flap necrosis, supporting the role of NIRS in identifying tissue at risk before clinical deterioration becomes evident. [5] Published clinical studies and real-world evidence further demonstrate that NIRS findings influence management decisions, including vascular referral, debridement, treatment modification, and escalation of care in patients with complex wounds. For example, real-world analyses have reported substantial impacts on treatment planning, care plan evaluation, and clinical decision-making across large cohorts of wound care patients. [6]

By providing objective physiologic information, NIRS helps clinicians determine when interventions such as debridement, cellular, acellular, and matrix-like products (CAMPs), hyperbaric oxygen therapy (HBOT), vascular evaluation, referral, treatment escalation, or modification of the plan of care may be clinically warranted. In doing so, NIRS can support more effective utilization of healthcare resources by providing objective information that helps guide these decisions.

Clinicians should make decisions using the best available information. Medicare appropriately expects providers to evaluate treatment effectiveness, identify treatment failure, modify plans of care when appropriate, and support those decisions with objective information whenever possible. Medicare policy should therefore foster, rather than hinder, these goals by supporting the evaluation and appropriate use of technologies that provide objective physiologic data.

While the proposed LCD acknowledges evidence supporting objective assessment of tissue oxygenation, perfusion-related clinical decision-making, postoperative flap monitoring, and clinically relevant applications in treatment planning and wound management, it nevertheless concludes that no clinically appropriate use warrants coverage. We respectfully submit that these findings support consideration of a stakeholder-informed coverage framework and targeted coverage criteria rather than blanket noncoverage.

Blanket noncoverage would limit access to objective diagnostic information regarding tissue oxygenation

A blanket noncoverage determination would deny Medicare coverage regardless of the patient's clinical circumstances or the documented reason for imaging. Existing clinical use does not assure continued access for Medicare beneficiaries. Explicit noncoverage would create a financial barrier even when the treating clinician documents a specific medical need for objective diagnostic information regarding tissue oxygenation. In practice, this would limit access to information that clinicians may use to evaluate treatment response, identify potential barriers to healing, support referral decisions, and determine whether modification of the plan of care is warranted.

This noncoverage proposal therefore creates tension with broader Medicare wound care policies. Medicare increasingly expects clinicians to identify treatment failure, reevaluate wound status, and modify plans of care when patients fail to progress as expected. Yet blanket noncoverage would eliminate access to an objective source of diagnostic information regarding tissue oxygenation that may inform these decisions. As a result, clinicians would be expected to make treatment, referral, and escalation decisions using less objective information than is currently available in routine practice.

Category III CPT status supports continued evaluation rather than blanket exclusion

The CPT Category III pathway was created to facilitate utilization tracking, evidence generation, and continued assessment of emerging technologies while clinical evidence matures. [7] Category III status should not be viewed as a rationale for blanket noncoverage. Rather, it represents an established mechanism through which utilization, outcomes, and clinical experience can continue to develop. Maintaining contractor pricing and discretionary coverage pathways would allow continued access in clinically appropriate circumstances while supporting further evidence development and helping to clarify the appropriate role of NIRS in clinical practice.

In summary, patients deserve access to NIRS because it provides objective diagnostic information regarding tissue oxygenation that assists clinicians in evaluating treatment response and determining when modification of the plan of care may be warranted. Medicare policies increasingly emphasize ongoing reevaluation of the wound, identification of treatment failure, and appropriate treatment modification when patients fail to progress as expected. A blanket noncoverage determination is difficult to reconcile with these shared goals.

We support evidence-based coverage policy and continued evaluation of emerging technologies. However, we believe that a stakeholder-informed review process involving clinicians, providers, professional societies, patients, manufacturers, and other interested parties would provide a stronger foundation for future coverage policy than immediate implementation of the proposed noncoverage determination.

Accordingly, we respectfully request withdrawal of the proposed NIRS LCD, development of an evidence-based framework for technologies that support reevaluation of the plan of care and clinical decision-making, and maintenance of existing coverage and reimbursement pathways while that framework is developed and evaluated.

Thank you for your attention to this matter. 

References

1. Newton E, Butskiy O, Shadgan B, et al. Outcomes of free flap reconstructions with near-infrared spectroscopy (NIRS) monitoring: A systematic review. Microsurgery. 2020;40(2):268-275.
2. Chen Y, Shen Z, Shao Z, et al. Free flap monitoring using near-infrared spectroscopy: A systematic review. Ann Plast Surg. 2016;76(5):590-597.
3. Berthelot M, Ashcroft J, Boshier P, et al. Use of near-infrared spectroscopy and implantable Doppler for postoperative monitoring of free tissue transfer: A systematic review and meta-analysis. Plast Reconstr Surg Glob Open. 2019;7(10).
4. Bian HZ, Pek CH, Hwee J. Current evidence on the use of near-infrared spectroscopy for postoperative free flap monitoring: A systematic review. Chin J Plast Reconstr Surg. 2022;4(4):194-202.
5. Hill WF, Kinaschuk K, Temple-Oberle C. Intraoperative Near-infrared Spectroscopy Can Predict Skin Flap Necrosis. Plastic and Reconstructive Surgery Global Open. 2024;12(3).
6. Kelso MR, Ohrt AR, Brunkan E, et al. Use of Near Infrared Spectroscopy in Post-Acute Care: Analysis of Real-World Clinical Decision-Making. J Wound Care. 2025;34(Suppl 6).
7. American Medical Association. Criteria for CPT® Codes. Updated June 16, 2026.