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.

Code Compendium (Wound Care)

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J5 - Wisconsin Physicians Service Insurance Corporation

• LCD LCA Wound Care L37228 A55909 - Insurance Corporation. F J8 - Wisconsin Physicians Service Insurance Corporation IA, KS, MO, NE IN. MI
• LCA Solna ee code 97610) A56175 - CBS Administrators, LLC (Part A/B MAC) KY, OH
• LCD LCA 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 L38904 A58567 - JF - Noridian Healthcare . Solutions, LLC JH Novitas AK, AZ, ID, MT, ND , OR, SD, UT, WA, WY
• LCD LCA Wound Care A53001 - Solutions, (Part A/B MAC) JL - Novitas Solutions, Inc. (Part A/B MAC) AR, CO, NM, OK, TX, LA, MS DE, D.C., MD, NJ, PA
• LCA Billing and Coding: Low Frequency, non-contact, non-thermal ultrasound AS4555 JJ - Palmetto GBA (Part A/B MAC) AL, GA, TN
• LCD LCA Near-Infrared Spectroscopy in Wound and Flap Management 139385 os ve ac (Par ) AL, GA, TN asgisg | /M-PalmettoGBA (Part A/B MAC) NC, SC, VA, WV

LCABilling and Coding: Low Frequency, non-contact, non-thermal ultrasoundA54555JM - Palmetto GBA (Part A/B MAC)NC, SC, VA, WV

LCD LCAWound CareL37166 A55818JN - First Coast Service Options, Inc. (Part A/B MAC)FL, PR, U.S. VI

Code Compendium (Wound Care)

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LCD LCAInfrared Heating Pad Systems

This document houses assorted wound care CPT and HCPCS codes.

• 97026, A4639, E0221 Monochromatic Infrared Energy Therapy
• 97610 Ultrasound Therapy for Wound Healing
• 0061U Spatial Frequency Domain Imaging

Monochromatic infrared energy (MIRE) therapy involves the use of devices that deliver single wavelength nonvisible light energy from the red end of the light spectrum via flexible pads that are applied to the skin. Each pad contains 60 infrared emitting diodes. MIRE therapy is thought to stimulate the release of nitric oxide from the hemoglobin of the blood, which dilates the blood vessels, thereby reducing swelling and increasing circulation.

MIRE has been proposed for treatment of conditions such as peripheral neuropathy, pain management and wound healing. An example of a MIRE device includes, but may not be limited to, the Anodyne Therapy System.

Low-frequency ultrasound is proposed as an adjunct treatment to standard wound care. A noncontact, low-frequency ultrasound device is intended to promote wound healing through cleansing and debridement of the wound bed. The device is held 0.5 to 1.5 cm from the wound and saline is delivered to the wound bed, which purportedly promotes healing through stimulation of cellular activity. Therapy generally consists of 3 to 12 minute sessions, three times per week.

Examples of low-frequency ultrasound devices include, but may not be limited to:

• AR1000 Ultrasonic Wound Therapy System
• AS1000 Ultrasound Wound Therapy System
• Jetox ND
• MIST Therapy System
• SonicOne O.R.
• SONOCA-185
• VERSAJET II Hydrosurgery System

Transcutaneous multispectral measurement of tissue oxygenation and hemoglobin using Spatial Frequency Domain Imaging (SFDI) is a noninvasive transcutaneous measurement of five biomarkers (tissue oxygenation [StO2], oxyhemoglobin [ctHbO2], deoxyhemoglobin [ctHbR], papillary and reticular dermal hemoglobin concentrations [ctHb1 and ctHb2]) using SFDI and multi-spectral analysis. Examples of US Food & Drug Administration (FDA) approved devices include, but may not be limited to, the Clarifi Imaging System and the Ox-Imager CS.

Near-infrared spectroscopy (NIRS) is a noninvasive technique using wavelengths claimed to measure deoxyhemoglobin, oxyhemoglobin, and ratio of tissue oxygenation in tissues within wounds as a proposed indication and potential of wound healing. An example of a US Food & Drug Administration (FDA) approved non-contact near-infrared spectroscopy device is the SnapshotNIR.

A handheld, noncontact imaging tool has been developed to aid clinicians in the assessment and treatment of chronic wounds during wound care. This device allows for viewing and digitally recording images, including the fluorescence emitted from the components of the wound (eg, bacteria, blood, skin, slough) when exposed to a violet light (excitation light). Those images would then purportedly detect the presence, location and load of clinically significant bacteria in order to inform decisions or revisions to an individual’s treatment plan. An example of a US Food & Drug Administration (FDA) approved imaging device is the MolecuLight i:X.

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.

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

Code Compendium (Wound Care)

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Low-Frequency, Non-Contact, Non-Thermal Ultrasound (MIST Therapy)

will be considered medically reasonable and necessary when (all) the following requirements are met:

• Any of the following clinical conditions:
  • Wounds and ulcers which are too painful for sharp or excisional debridement and have failed conventional debridement with documentation supporting the same; OR
  • Wounds and ulcers meeting Medicare coverage for debridement but with documented contraindications to sharp or excisional debridement; OR
  • Wounds and ulcers meeting Medicare coverage for debridement but with documented evidence of no signs of improvement after 30 days of standard wound care
• Low-frequency, non-contact, non-thermal ultrasound (MIST Therapy) may be provided two to three times per week to be considered reasonable and necessary. The length of individual treatments will vary per wound size.
• Observable, documented improvements in the wound(s) should be evident after six treatments.

Improvements include documented reduction in pain, necrotic tissue, or wound size, or improved granulation tissue.7-11The 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

The following services/items will not be considered medically reasonable and necessary:

• Monochromatic Infrared Energy Therapy
• Spatial Frequency Domain Imaging
• Near-Infrared Spectroscopy
• Noncontact Real-Time Bacterial Fluorescent Imaging of Wounds

A review of the current medical literature shows that the evidence is insufficient to determine that these services are standard medical treatments. There remains an absence of randomized, blinded clinical studies examining benefit and long-term clinical outcomes establishing the value of these services in clinical management.

Code Compendium (Wound Care)

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Summary of Evidence

Monochromatic Infrared Energy Therapy (MIRE)

There is insufficient published evidence to assess the safety and/or impact of MIRE therapy on health outcomes or patient management for nonhealing wounds.26

There is insufficient published evidence to assess the safety and/or impact of MIRE therapy on patient management or health outcomes in patients with peripheral neuropathy.25

Spatial Frequency Domain Imaging (SFDI)

SFDI parameters measuring hemoglobin and oxygen-bound hemoglobin in the skin’s dermis may eventually be used to estimate foot ulcer risk, but the available clinical research data are insufficient to determine how well it will work compared with other potential diagnostic methods. Additional studies are needed that compare SFDI with other imaging systems, such as optical coherence tomography, near-infrared spectroscopy, laser Doppler imaging, digital camera imaging, and thermal and fluorescence imaging.15

Near-Infrared Spectroscopy (NIRS)

The SnapshotNIR device detected normal spatial and temporal differences in tissue oxygenation over the operative course of alloplastic and autologous breast reconstruction. A multi-institutional, prospective clinical trial is needed to determine the sensitivity and specificity of this device for detecting skin flap necrosis.30

Noncontact Real-Time Bacterial Fluorescent Imaging of Wounds

Evidence from two diagnostic cohort studies and one before-and-after study suggests that adding MolecuLight i:X to CSS assessment improves identification of moderate-to-high bacterial loads in venous leg ulcers, pressure ulcers, and diabetic foot ulcers (DFUs), but the studies are at too high a risk of bias to determine whether MolecuLight i:X improves patient outcomes (e.g., complete wound healing, time to wound healing, infection rates).13