Patients with hard-to-heal wounds need care based on the best available evidence. Real-time fluorescence wound imaging helps clinicians identify elevated bacterial burden that may not be apparent during a routine examination, providing information to guide targeted cleansing, debridement, and treatment decisions.
Join the Wound and Hyperbaric Association in urging Medicare Administrative Contractors to withdraw the proposed blanket noncoverage policies for real-time fluorescence wound imaging. Coverage should support medically necessary, evidence-supported use based on clinical judgment and each patient’s needs.
Add your voice to support access to these wound assessment tools. Please use the custom message box to include details about your unique experience or reference the proposed LCD number mentioned below. 
Recipient MAC Proposed LCD number and CMS links:
<ul>
<li>CGS <a href="https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=40467&ver=8" target="_blank">DL40468</a>&nbsp;</li>
<li>First Coast <a href="https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=40414&ver=9" target="_blank">DL40415</a>&nbsp;</li>
<li>NGS / Wellpoint Federal <a href="https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=40438&ver=8" target="_blank">DL40439</a>&nbsp;</li>
<li>Noridian <a href="https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=40440&ver=5" target="_blank">DL40441</a>&nbsp;</li>
<li>Novitas <a href="https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=40412&ver=31" target="_blank">DL40413</a>&nbsp;</li>
<li>Palmetto <a href="https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=40442&ver=6" target="_self">DL40443</a>&nbsp;</li>
<li>WPS <a href="https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=40436&ver=5" target="_blank">DL40437</a>&nbsp;</li>
</ul>

Request to Withdraw Blanket Noncoverage of Fluorescence Wound Imaging

We, the undersigned, respectfully urge the Medicare Administrative Contractors (MACs) to reevaluate the accumulated clinical evidence, withdraw the proposed blanket noncoverage determination for real-time fluorescence wound imaging (RTFWI), and provide coverage for medically necessary use to guide wound assessment and management.

The accumulated evidence demonstrates improved detection of elevated bacterial burden and reports favorable patient outcomes when imaging informs wound management. Randomized trials, observational studies and published clinical guidance address complementary aspects of its clinical value. Differences in evidence strength warrant consideration when defining appropriate coverage. They do not, in our view, justify excluding every indication.1–5


Imaging adds information that helps clinicians guide care

RTFWI provides objective information about the location and extent of elevated bacterial burden that may not be apparent on clinical assessment alone. Clinicians integrate these findings with the wound examination, patient history and other information to guide targeted cleansing, debridement, microbiological sampling and treatment decisions. Its clinical value lies in the care informed by this additional information.1,2


Clinical studies report favorable patient outcomes

The Hsu randomized trial reported favorable healing and other clinical outcomes with fluorescence-guided surgical debridement. The Rahma pilot randomized trial reported favorable healing findings in diabetic foot ulcers, providing additional randomized evidence in a different clinical setting. Kelso’s observational study reported favorable healing and infection-related hospitalization findings among Medicare beneficiaries with pressure injuries in long-term care and skilled nursing facilities which is a population directly relevant to this coverage decision. Each study should be weighed according to its design and limitations, while recognizing the clinical benefits reported. These findings support coverage for evidence-supported uses rather than blanket exclusion.3–5


Fluorescence guided treatment is the clinical strategy being evaluated

RTFWI is intended to improve care by informing treatment decisions. When imaging identifies bacterial burden that prompts additional or more targeted debridement, that intervention is part of the intended clinical strategy and a potential mechanism of benefit. The Hsu trial therefore provides evidence about fluorescence-guided debridement, rather than imaging performed without a treatment response. Differences in protocols and study design remain relevant to interpreting the findings, but the treatment changes informed by imaging should be considered when assessing its clinical value.3


Imaging guides targeted wound care and appropriate treatment decisions

Published clinical guidance describes how fluorescence imaging can localize elevated bacterial burden to guide targeted cleansing, debridement and microbiological sampling. RTFWI can help clinicians identify where further wound bed preparation may be needed, including through assessment of residual fluorescence after cleansing or debridement. Clinicians integrate these findings with the complete clinical assessment to inform treatment decisions, including appropriate escalation or reduction of antimicrobial treatment. Objective fluorescence imaging may also support antimicrobial stewardship by providing additional information about the presence and location of elevated bacterial burden at the point of care. Published observational studies have reported shifts away from routine systemic antibiotic use and toward more targeted local interventions following implementation of fluorescence imaging in wound care practice. By helping clinicians distinguish wounds that may benefit from additional cleansing, debridement, topical antimicrobials, microbiological sampling, or escalation of care, RTFWI can support more judicious antimicrobial decision-making rather than indiscriminate treatment.

Imaging supplements clinical assessment rather than independently establishing infection. These uses support established wound care goals and, considered alongside the clinical outcome evidence, strengthen the rationale for medically necessary coverage.2,3

This noncoverage proposal creates a direct conflict with broader Medicare wound care policies. MACs routinely require clinicians to demonstrate infection control and a clean wound bed prior to initiating advanced wound therapies. Denying coverage for RTFWI deprives clinicians of the objective, point-of-care data required to meet these exact Medicare-mandated clinical benchmarks.


Blanket noncoverage would deny coverage even when imaging addresses a documented clinical need

While the proposed LCD acknowledges evidence of improved bacterial detection, changes in clinical management, antimicrobial stewardship, and favorable findings in wound healing and healthcare utilization studies, it nevertheless concludes that no clinically appropriate use warrants coverage. We respectfully submit that these findings support consideration of targeted coverage criteria rather than blanket noncoverage.

This noncoverage proposal therefore creates tension with broader Medicare wound care policies, as MACs routinely require clinicians to assess infection control and establish appropriate wound bed preparation prior to initiating advanced wound therapies. Yet blanket noncoverage would remove a currently available source of objective point-of-care information that can assist clinicians in evaluating these important clinical considerations. By eliminating an established adjunctive assessment tool from existing clinical workflows, the proposed LCD would reduce access to information that can inform wound bed preparation, targeted debridement, microbiological sampling, and antimicrobial stewardship, requiring clinicians to make these management decisions with less objective information than is currently available in routine practice.


Category I CPT recognition reinforces the case for medically necessary coverage

Category I CPT recognition reflects that the procedure has met AMA criteria addressing clinical use, consistency with current medical practice, and published evidence of clinical efficacy. This recognition reinforces the clinical evidence supporting RTFWI and warrants meaningful consideration in the coverage review. Although coding recognition does not independently establish Medicare coverage, it strengthens the case for evaluating evidence-supported indications rather than excluding every use through blanket noncoverage.6,7
Coverage should support judicious use based on clinical need

We support judicious use based on clinical need, appropriate training, clinical judgment and documentation of how imaging findings inform care. We do not seek automatic imaging of every wound on every visit. Decisions about repeat imaging should be guided by the clinical circumstances and the information needed to manage the wound.
We request withdrawal of blanket noncoverage and coverage for appropriate use

We respectfully request that the MACs withdraw the proposed blanket noncoverage determination and provide coverage for medically necessary, evidence-supported use of RTFWI. Where concerns remain about patient selection or repeat imaging, those concerns should be addressed through appropriate coverage criteria and documentation requirements. Such an approach would recognize the favorable clinical evidence, support responsible utilization and preserve access for Medicare beneficiaries whose care can benefit from imaging-guided management.

Thank you for considering our comments.


References
1. Le L, Baer M, Briggs P, et al. Diagnostic Accuracy of Point-of-Care Fluorescence Imaging for the Detection of Bacterial Burden in Wounds: Results from the 350-Patient Fluorescence Imaging Assessment and Guidance Trial. Adv Wound Care. 2021;10(3):123–136. doi:10.1089/wound.2020.1272.
2. International Wound Infection Institute. Wound Infection in Clinical Practice. 4th ed. Wounds International; 2026.
3. Hsu JC, Chu YH, Wu YC, et al. Application of Perioperative Real-Time Fluorescence Imaging to Achieve High-Quality Debridement: A Randomized Control Trial. Adv Wound Care. Published online July 14, 2025. doi:10.1177/21621918251359558.
4. Rahma S, Woods J, Brown S, Nixon J, Russell D. The Use of Point-of-Care Bacterial Autofluorescence Imaging in the Management of Diabetic Foot Ulcers: A Pilot Randomized Controlled Trial. Diabetes Care. 2022;45(7):1601–1609. doi:10.2337/dc21-2218.
5. Kelso MR, Jaros M. Improving Wound Healing and Infection Control in Long-term Care with Bacterial Fluorescence Imaging. Adv Skin Wound Care. 2024;37(9):471–479. doi:10.1097/ASW.0000000000000177.
6. American Medical Association. Criteria for CPT codes. Updated June 16, 2026. https://www.ama-assn.org/practice-management/cpt/criteria-cpt-codes
7. American Medical Association. CPT code set: The basics and resources. https://www.ama-assn.org/practice-management/cpt/cpt-code-set-basics-and-resources