Table of Contents

• Provider Claim Codes: 97026, A4639, E0221
  Section Title: Monochromatic Infrared Energy Therapy
• Provider Claim Codes: 97610
  Section Title: Ultrasound Therapy for Wound Healing
• Provider Claim Codes: 0061U
  Section Title: Spatial Frequency Domain Imaging
• Provider Claim Codes: 0493T, 0640T, 0641T, 0642T, 0859T, 0860T
  Section Title: Near-Infrared Spectroscopy
• Provider Claim Codes: 0598T, 0599T
  Section Title: Noncontact Real-Time Bacterial Fluorescent Imaging of Wounds

Monochromatic Infrared Energy Therapy Section

Effective Date: 09/28/2023

Section Revision Date: 09/28/2023

Section Review Date: 09/28/2023

Change Summary: Updated References

Page: 1 of 12

Code Compendium (Wound Care) Policy Number: HUM-0607-004
Page: 2 of 12

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Description

• 97026: Application of a modality to 1 or more areas; infrared
  to report Monochromatic Infrared Energy Therapy
• A4639: Replacement pad for infrared heating pad each
  Not Covered
• E0221: Infrared heating pad system
  Not Covered

Not Covered if used to report Monochromatic Infrared Energy Therapy

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.

Coverage Determination

Humana members may NOT be eligible under the Plan for MIRE therapy for any indication. This is considered experimental/investigational as it is not identified as widely used and generally accepted for the proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language.

This policy does not address infrared treatment when used as a modality of physical therapy, which may be a covered service. (For information regarding coverage determination/limitations for infrared treatment when used as a modality, please refer to Physical Therapy and Occupational Therapy Medical Coverage Policy)

Note: The criteria for MIRE are consistent with the Medicare National Coverage Policy and therefore apply to Medicare members.

Code Compendium (Wound Care) Policy Number: HUM-0607-004
Page: 3 of 12

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

References

1. Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD). Infrared therapy devices (270.6). https://www.cms.gov. Published October 24, 2006. Accessed August 22, 2023.
2. Hayes, Inc. Evidence Analysis Research Brief. Monochromatic infrared energy therapy for treatment of neuropathic pain. https://evidence.hayesinc.com. Published April 10, 2023. Accessed August 14, 2023.
3. Hayes, Inc. Health Technology Brief (ARCHIVED). Anodyne therapy system (Anodyne Therapy LLC) for peripheral neuropathy. https://evidence.hayesinc.com. Published February 25, 2008. Updated February 11, 2010. Accessed August 14, 2023.

1. MIRE therapy (monochromatic infrared energy) for peripheral neuropathy. https://evidence.hayesinc.com. Published April 6, 2018. Accessed April 3, 2020.
2. Hayes, Inc. Search & Summary (ARCHIVED). MIRE therapy (monochromatic infrared energy) for treatment of wounds. https://evidence.hayesinc.com. Published April 6, 2018. Accessed April 3, 2020.

Ultrasound Therapy for Wound Healing Section

Effective Date: 09/28/2023

Section Revision Date: 09/28/2023

Section Review Date: 09/28/2023

Change Summary: Updated References

• 97610: ultrasound, including topical application(s), when performed, wound assessment, and instruction(s) for ongoing care, per day
  Not Covered

Description

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

Coverage Determination

Humana members may NOT be eligible under the Plan for ultrasound therapy for wound healing. This is considered experimental/investigational as it is not identified as widely used and generally accepted for the proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language.

Code Compendium (Wound Care) Policy Number: HUM-0607-004
Page: 4 of 12

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

References

1. American College of Physicians (ACP). Treatment of pressure ulcers: a clinical practice guideline from the American College of Physicians (ARCHIVED). https://www.acponline.org. Published March 3, 2015. Accessed August 24, 2023.
2. ECRI Institute. Clinical Evidence Assessment. SonicOne O.R. system (Misonix, Inc.) for debriding wounds. https://www.ecri.org. Published October 6, 2017. Updated March 29, 2022. Accessed August 14, 2023.
3. ECRI Institute. Clinical Evidence Assessment. Versajet hydrosurgery system (Smith & Nephew, Inc.) for debriding burn wounds. https://www.ecri.org. Published October 9, 2006. Updated April 21, 2022. Accessed August 14, 2023.
4. ECRI Institute. Clinical Evidence Assessment. Versajet II hydrosurgery system (Smith & Nephew, Inc.) for debriding chronic wounds. https://www.ecri.org. Published March 29, 2019. Updated April 11, 2022. Accessed August 14, 2023.
5. ECRI Institute. Hotline Response (ARCHIVED). Noncontact, low-frequency ultrasound for healing chronic wounds. https://www.ecri.org. Published November 21, 2007. Updated March 26, 2012. Accessed August 14, 2023.
6. ECRI Institute. Product Brief (ARCHIVED). MIST therapy system (Alliqua Biomedical, Inc.), noncontact, low-frequency ultrasound for healing chronic wounds. https://www.ecri.org. Published July 16, 2014. Updated December 2, 2016. Accessed August 14, 2023.

Code Compendium (Wound Care) Policy Number: HUM-0607-004
Page: 5 of 12

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Hayes, Inc. Health Technology Brief (ARCHIVED).

9. Hayes, Inc. Health Technology Brief (ARCHIVED). Noncontact low-frequency ultrasound using the MIST therapy system (Celleration Inc.) for treatment of lower extremity arterial and diabetic foot ulcers. https://evidence.hayesinc.com. Published June 30, 2016. Updated June 8, 2018. Accessed August 15, 2023.
10. Hayes, Inc. Health Technology Brief (ARCHIVED). Noncontact low-frequency ultrasound using the MIST therapy system (Celleration Inc.) for treatment of venous leg ulcers. https://evidence.hayesinc.com. Published June 30, 2016. Updated June 8, 2018. Accessed August 15, 2023.
11. Hayes, Inc. Health Technology Brief (ARCHIVED). VersaJet II hydrosurgery system (Smith & Nephew Inc.) for treatment of burns. https://evidence.hayesinc.com. Published December 26, 2013. Updated December 9, 2015. Accessed August 15, 2023.
12. National Pressure Ulcer Advisory Panel (NPUAP). Clinical Practice Guideline. Prevention and treatment of pressure ulcers/injuries: quick reference guide. https://www.npuap.org. Published 2019. Accessed August 24, 2023.
13. UpToDate, Inc. Basic principles of wound management. https://www.uptodate.com. Updated July 2023. Accessed August 21, 2023.
14. UpToDate, Inc. Clinical staging and management of pressure-induced skin and soft tissue injury. https://www.uptodate.com. Updated July 2023. Accessed August 21, 2023.

Spatial Frequency Domain Imaging Section

Effective Date: 09/28/2023

Section Revision Date: 09/28/2023

Code Compendium (Wound Care) Policy Number: HUM-0607-004
Page: 6 of 12

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Section Review Date: 09/28/2023

Change Summary: Updated References

Description

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.

Coverage Determination

Humana members may NOT be eligible under the Plan for SFDI for the measurement of tissue oxygenation and hemoglobin. This is considered experimental/investigational as it is not identified as widely used and generally accepted for the proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language.

References

1. ECRI Institute. Clinical Evidence Assessment. Spatial frequency domain imaging for assessing risk of foot ulcer development. https://www.ecri.org. Published November 11, 2022. Accessed August 14, 2023.
2. Lee S, Mey L, Szymanska AF, et al. SFDI biomarkers provide a quantitative ulcer risk metric and can be used to predict diabetic foot ulcer onset. J Diabetes Complications. 2020;34(9):107624.
3. US Food & Drug Administration (FDA). 510(k) summary: Clarifi Imaging System. https://www.fda.gov. Published July 19, 2018. Accessed March 29, 2022.
4. US Food & Drug Administration (FDA). 510(k) summary: Ox-Imager CS. https://www.fda.gov.

Code Compendium (Wound Care) Policy Number: HUM-0607-004
Page: 7 of 12

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

5. Weinkauf C, Mazhar A, Vaishnav K, et al. Near-instant noninvasive optical imaging of tissue perfusion for vascular assessment. J Vasc Surg. 2019;69(2):555–562.
6. Yafi A, Muakkassa FK, Pasupneti T, et al. Quantitative skin assessment using spatial frequency domain imaging (SFDI) in patients with or at high risk for pressure ulcers. Lasers Surg Med. 2017;49(9):827-834.

Near-Infrared Spectroscopy Section

Effective Date: 09/28/2023

Section Revision Date: 09/28/2023

Section Review Date: 09/28/2023

Change Summary: Updated References

0493T: extremity wounds (eg, for oxyhemoglobin measurement) - Not Covered

0640T: Noncontact near-infrared spectroscopy studies of flap or wound (eg, for measurement of deoxyhemoglobin, oxyhemoglobin, and ratio of tissue oxygenation [StO2]); image acquisition, interpretation and report, each flap or wound - Not Covered

0641T: Noncontact near-infrared spectroscopy studies of flap or wound (eg, for measurement of deoxyhemoglobin, oxyhemoglobin, and ratio of tissue oxygenation [StO2]); image acquisition only, each flap or wound - Not Covered

0642T: Noncontact near-infrared spectroscopy studies of flap or wound (eg, for measurement of deoxyhemoglobin, oxyhemoglobin, and ratio of tissue oxygenation [StO2]); interpretation and report only, each flap or wound - Not Covered

0859T: Noncontact near-infrared spectroscopy (eg, for measurement of deoxyhemoglobin, oxyhemoglobin, and ratio of tissue oxygenation) - Not Covered

0860T: for screening for peripheral arterial disease, including provocative maneuvers, image acquisition, interpretation, and report, one or both lower extremities - Not Covered

Code Compendium (Wound Care) Policy Number: HUM-0607-004
Page: 8 of 12

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

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.

Coverage Determination

Humana members may NOT be eligible under the Plan for NIRS for the measurement of tissue oxygenation. This is considered experimental/investigational as it is not identified as widely used and generally accepted for the proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language.

References

1. Landsman A. Visualization of wound healing progression with near infrared spectroscopy: a retrospective study. Wounds. 2020;32(10):265-271.
2. MCG Health. Noncontact normothermic wound therapy. 27th edition. https://www.mcg.com. Accessed August 21, 2023.
3. Moritz WR, Daines J, Christensen JM, et al. Point-of-care tissue oxygenation assessment with SnapshotNIR for alloplastic and autologous breast reconstruction. Plast Reconstr Surg Glob Open. 2023;11(7):e5113.

Code Compendium (Wound Care) Policy Number: HUM-0607-004
Page: 9 of 12

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

References

7. Neidrauer M, Zubkov L, Weingarten MS, et al. Near infrared wound monitor helps clinical assessment of diabetic foot ulcers. J Diabetes Sci Technol. 2010;4(4):792-798.
8. Serena TE, Yaakov R, Serena L, et al. Comparing near infrared spectroscopy and transcutaneous oxygen measurement in hard-to-heal wounds: a pilot study. J Wound Care. 2020;29(Sup6):S4-S9.
9. US Food & Drug Administration (FDA). 510(k) summary: SnapshotNIR. https://www.fda.gov. Published November 10, 2020. Accessed August 24, 2022.

Noncontact Real-Time Bacterial Fluorescent Imaging of Wounds Section

Effective Date: 09/28/2023

Section Revision Date: 09/28/2023

Section Review Date: 09/28/2023

Change Summary: Updated Description, References

Description

• 0598T: imaging, for bacterial presence, location, and load, per session; first anatomic site (eg, lower extremity)
  Not Covered
• 0599T: imaging, for bacterial presence, location, and load, per session; each additional anatomic site (eg, upper extremity) (List separately in addition to code for primary procedure)
  Not Covered

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. Examples of a US Food & Drug Administration (FDA) approved imaging devices include, but may not be limited to, the MolecuLight i:X and MolecuLightDX.

Code Compendium (Wound Care) Policy Number: HUM-0607-004
Page: 10 of 12

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Coverage Determination

Humana members may NOT be eligible under the Plan for noncontact real-time bacterial fluorescent imaging of wounds. This technology is considered experimental/investigational as it is not identified as widely used and generally accepted for the proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language.

References

1. ECRI Institute. Clinical Evidence Assessment. MolecuLight i:X Fluorescence Imaging System (MolecuLight, Inc.) for managing chronic wounds. https://www.ecri.org. Published February 26, 2021. Updated March 20, 2023. Accessed August 14, 2023.
2. Hayes, Inc. Clinical Research Response. MolecuLight (MolecuLight Corp.). https://evidence.hayesinc.com. Published March 16, 2023. Accessed August 15, 2023.
3. US Food & Drug Administration (FDA). 510(k) summary: MolecuLight i:X. https://www.fda.gov. Published December 4, 2019. Accessed June 1, 2021.
4. US Food & Drug Administration (FDA). 510(k) summary: MolecuLightDX. https://www.fda.gov. Published July 21, 2021. Accessed August 25, 2023.

Provider Claims Codes

Any CPT, HCPCS or ICD codes listed on this medical coverage policy are for informational purposes only. Do not rely on the accuracy and inclusion of specific codes.

Inclusion of a code does not guarantee coverage and or reimbursement for a service or procedure.

CPT® Code(s)

• 97026: Application of a modality to 1 or more areas; infrared
  Not Covered if used to report Monochromatic Infrared Energy Therapy
• 97610: Low frequency, non-contact, non-thermal ultrasound, including topical application(s), when performed, wound assessment, and instruction(s) for ongoing care, per day
  Not Covered

Code Compendium (Wound Care) Policy Number: HUM-0607-004
Page: 11 of 12

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

0061U

• oxygenation [StO2], oxyhemoglobin [ctHbO2], deoxyhemoglobin [ctHbR], papillary and reticular dermal hemoglobin concentrations [ctHb1 and ctHb2]), using spatial frequency domain imaging (SFDI) and multi-spectral analysis
  Not Covered

CPT® Category Ill Code(s)

• 0598T: Noncontact real-time fluorescence wound imaging, for bacterial presence, location, and load, per session; first anatomic site (eg, lower extremity)
  Not Covered
• 0599T: Noncontact real-time fluorescence wound imaging, for bacterial presence, location, and load, per session; each additional 7 anatomic site (eg, upper extremity) (List separately in addition to code for primary procedure)
  Not Covered
• 0640T: Noncontact near-infrared spectroscopy studies of flap or wound (eg, for measurement of deoxyhemoglobin, oxyhemoglobin, and ratio of tissue oxygenation [StO2]); image acquisition, interpretation and report, each flap or wound
  Not Covered
• 0641T: Noncontact near-infrared spectroscopy studies of flap or wound (eg, for measurement of deoxyhemoglobin, oxyhemoglobin, and ratio of tissue oxygenation [StO2]); image acquisition only, each flap or wound
  Not Covered Deleted Code Effective 12/31/2023
• 0642T: Noncontact near-infrared spectroscopy studies of flap or wound (eg, for measurement of deoxyhemoglobin, oxyhemoglobin, and ratio of tissue oxygenation [StO2]); interpretation and report only, each flap or wound
  Not Covered Deleted Code Effective 12/31/2023
• 0859T: Noncontact near-infrared spectroscopy (eg, for measurement of deoxyhemoglobin, oxyhemoglobin, and ratio of tissue oxygenation), other than for screening for peripheral arterial disease, image acquisition, interpretation, and report; each additional anatomic site (List separately in addition to code for
  Not Covered New Code Effective 01/01/2024

Code Compendium (Wound Care) Policy Number: HUM-0607-004
Page: 12 of 12

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

New Code Effective 01/01/2024

• A4639: Replacement pad for infrared heating pad system, each
  Not Covered
• E0221: Infrared heating pad system
  Not Covered