APWCA Position Statement: Point-of-care bacterial autofluorescence imaging in the assessment and management of hard-to-heal wounds

This statement summarizes the clinical rationale and published evidence for point-of-care bacterial fluorescence imaging.It sets out APWCA recommendations for clinical practice and for coverage policy.The statement addresses hard-to-heal wounds.Evidence from burns and surgical wounds is included where those wounds are at risk of delayed healing, such as before grafting, after dehiscence, or during perioperative care.It is directed to wound care providers and to the Centers for Medicare & Medicaid Services (CMS), Medicare Administrative Contractors (MACs), Medicare Advantage Organizations, State Medicaid programs, commercial health plans, health technology assessment bodies, and medical policy and utilization management committees.On October 1, 2026, all seven MACs issued proposed local coverage determinations (LCDs) that would classify realtime fluorescence wound imaging for bacterial presence as non-covered on the grounds that it is "not reasonable and necessary."The statutory public comment period closes November 14, 2026.8 This statement reviews the evidence considered in those proposals, together with additional published evidence.Hard-to-heal wounds disproportionately affect older adults, Medicare beneficiaries, people with diabetes, residents of skilled nursing and long-term care facilities, and people with impaired mobility.9 In these populations, elevated bacterial burden and delayed recognition of infection may contribute to impaired healing, infectious complications, and increased antimicrobial use.3,4,7,10,11 3. Clinical Rationale: The Persistent Wound Environment Hard-to-heal wounds commonly exist in a persistent pathological state.It is characterized by polymicrobial biofilm, dysregulated inflammation, and elevated bacterial burden that may be present before conventional clinical signs of 1. Executive Summary The American Professional Wound Care Association (APWCA) supports the reasonable and medically necessary use of pointof-care bacterial fluorescence diagnostic imaging as an adjunct to comprehensive clinical assessment in the management of hard-to-heal wounds.This technology is also referred to as real-time fluorescence wound imaging (RTFWI), a term reflected in updated Current Procedural Terminology (CPT) coding and proposed Medicare coverage policies.Most wounds exhibiting critical colonization or elevated bacterial burden, defined in this statement as bacterial loads above 10⁴ CFU/g, do not exhibit clinical signs or symptoms that reliably indicate their presence within the wound bed.In a 350-patient multicenter trial, clinical assessment alone demonstrated a sensitivity of only 15.3% for detecting elevated bacterial bioburden.When bacterial fluorescence imaging was added, sensitivity increased to 61.0% while specificity was maintained. 1 Fluorescence imaging provides actionable information at the point of care.In the largest studies, imaging findings altered treatment plans in approximately one-half to two-thirds of evaluated wounds, including changes in debridement, cleansing, tissue sampling, and antimicrobial management.1,2 Two randomized controlled trials and multiple cohort studies further suggest that fluorescence-guided care may improve healing, reduce recurrent infection, and decrease unnecessary antimicrobial use.[3][4][5][6][7] The evidence is strongest for improved detection of elevated bacterial burden and for its influence on treatment decisions.Evidence for downstream outcomes, including healing, infectious complications, and antimicrobial use, is growing and currently comes largely from single-center and observational studies. Key recommendations:• APWCA supports the appropriate use of point-of-care bacterial fluorescence diagnostic imaging as an adjunct to clinical assessment when findings are reasonably expected to influence wound management.Diagnostic imaging can reveal and localize elevated bacterial burden that is not apparent on clinical examination.These findings inform targeted debridement, microbiological sampling, antimicrobial management, and assessment of wound bed readiness before selected advanced therapies.Coverage should apply when imaging is performed with an FDA-authorized device supported by device-specific clinical performance evidence, and when medical necessity and the resulting management decisions are documented.Blanket noncoverage would create a barrier to access that the available evidence does not justify.• Use bacterial fluorescence diagnostic imaging as an adjunct to, not a replacement for history, physical examination, clinical judgment, and microbiologic testing when indicated.• Perform diagnostic imaging, including repeat diagnostic imaging, when the result is reasonably expected to influence management, including during initial wound assessment, when healing is stalled, before and after debridement, before selected advanced therapies, and when antimicrobial therapy is being considered.Diagnostic imaging should generally be no more than weekly unless more frequent imaging is medically necessary and documented.