Response to Comments: Near-Infrared Spectroscopy in Wound and Flap Management

We appreciate the opportunity to provide comments regarding the non-coverage policy decision DL39385 for non-contact near-infrared spectroscopy use in acute or chronic wound assessment and management and for use in flap or micro-flap assessment intra- or post-operatively.

Overall, we believe that NIR technologies used for real time wound and flap imaging have cost- saving clinical impacts to Palmetto GBA that were not captured within its initial evaluation given its unique and novel fit in the delivery of healthcare.

To date, there is over 30 years of evidence using near-infrared spectroscopy in clinical medicine, ranging from brain - cerebral oxygenation, stroke prediction, peripheral vascular disease, trauma, burns and wound care. This was initially dominated by fibre-based technologies resting on the skin in multiple locations. With recent advancements in computing power (laptop, smartphone & cloud computing), the transition to near-infrared spectroscopy (NIRS) as an imaging platform is advantageous.

Emerging NIR technologies are FDA cleared and/or approved for measuring tissue oximetry spatially for an area of tissue. Such technologies allow for not only more convenient and efficient assessments compared to traditional tools, but it also equips more providers with more information to make effective clinical decisions. The decades of evidence for NIRS and its transition into an imaging modality has unrealized benefits for patient outcomes and cost- savings for the health system.

Tissue oximetry is a cornerstone in wound care (Banerjee 2012), though, as acknowledged in the policy decision as well, current wound care practice involves mainly visual inspection and physical measurements. Though inconsistently practiced, when further tools are used, they are limited by its requirement of contacting the patient’s skin and/or wound with potential pain, patients needing to stay still for accurate measurement, inefficient due to its timely nature, and not portable to support off-site/mobile wound care services. Tissue oximetry has been shown to correlate with standard vascular assessment tools used in wound care, including tcPO2, ankle brachial index, and skin perfusion pressure test (Yata et al. 2019) (Kayama et al. 2021). NIRS technology that measures tissue oximetry therefore offer a solution to the clinical need of a convenient and portable tool to support clinical decision making in wound care.

In the policy decision, it was noted that there have been little improvements in study quality over time though decades of enthusiasm for NIRS, with mention of new handheld instruments. However, what was not mentioned was how recent such handheld imaging technologies have been introduced to the market and the impacts of COVID-19 which prevented and delayed quality trials from being conducted. In light of the novelty of such handheld NIR technologies and impacts of COVID-19, we have been conducting an intervention study (n=300) in Canada which deployed a handheld NIRS device that was incorporated into diabetic footcare provided by mobile wound care nurses. Preliminary results were presented at DFCon 2022 in September and presently at Fall SAWC 2022 that outlined its impact to footcare and improvements to clinical decision making and quality of life.

The policy decision also cites the lack of level I evidence as a reason for non-coverage. However, the evolution of what defines appropriate wound care endpoints within clinical trials have changed how technologies that support clinical decision making should be evaluated. It has been recently recognized that wound healing and complete closure is not the only endpoint that is important to patients and clinicians, but rather endpoints that considers the quality of life and measures of wound progression are of equal or greater importance. (Gould et al., 2021) This includes increased oxygenation and blood flow to the wound. This is an implied acceptance and recognition of the importance for technologies that measures these endpoints in wound care. Not covering such technologies prevent providers from making appropriate care decisions and ultimately improving meaningful patient outcomes resulting in cost savings.

Therefore, we kindly request that Palmetto GBA reconsiders its non-coverage policy decision for non-contact near-infrared spectroscopy use in acute or chronic wound assessment and management and for use in flap or micro-flap assessment intra- or post- operatively.

References

Banerjee, J., Sen, C.K. 2012. "Wound Tissue Oximetry: A Cornerstone in Wound Care." In Measurements in Wound Healing, by R., Romanelli, M., Shukla, V. Mani. London: Springer.

Gould, LJ, Liu, J, Wan, R, Carter, MJ, Dotson, M(P), Driver, VR. Evidence supporting wound care end points relevant to clinical practice and patients' lives. Part 3: The Patient Survey. Wound Rep Reg. 2021; 29: 60– 69. https://doi.org/10.1111/wrr.12872

Kayama et al., 2021. "A Pilot study investigation the use of regional oxygen saturation as a predictor of ischemic wound healing outcome after endovascular treatment in patients with chronic limb threatening ischemia." Ann Vasc Dis. 23-30.

Yata et al. 2019. "Utility of a Finger Mounted Tissue Oximeter with NIR Spectroscopy to Evaluate Limb Ischemia in Patients with Peripheral Arterial Disease." Ann Vasc Dis. 36-43.

Thank you for your informed comments. The four additional references submitted by the commenter were reviewed as possible; specifically, the full text of the Gould et al. paper concerning the patient survey could not be accessed. The latter two references above are related studies of an observational nature with small subject numbers restricted to a Japanese patient demographic. Thus, any applicability to this policy is difficult to ascertain. No substantial conclusions can be drawn. Furthermore, there is no clear relationship between wound healing and regional oxygen saturations that can be drawn from these limited studies. Establishing that finger-mounted tissue oximetry can easily measure regional tissue oxygen saturation still does not lead to a conclusion that it is reasonable and necessary in comparison to other more standard diagnostic and/or therapeutic approaches. Essentially the serious limitations of these studies in terms of subject numbers and/or lack of Medicare beneficiary applicability render this evidence unpersuasive for the policy at hand. One of these references (Gould et al.) presented an Opinion Survey from People with Wounds. This survey was apparently done to identify patient perspectives regarding clinically meaningful and scientifically achievable primary endpoints for wound care. The survey was pilot tested and revised based on a limited number of patients in a single clinic. Then it was administered in English and Spanish and submitted anonymously to a server with response from 438 patients and caregivers over a 10-month period. The full article could not be accessed. [In fact, none of these referenced papers were submitted in their entirety by the commenter.] This survey noted valuable clinical endpoints such as reduced infection, recurrence, and amputation and quality of life outcomes such as increased independence, reduced social isolation, and pain. The top five endpoints in terms of usefulness for measuring clinical trial success were time to heal, wound size, infection, recurrence, and pain. It was not clear how any of these wound healing endpoints was specifically driven by the performance of wound spectroscopy nor how spectroscopy affected treatment outcomes. The survey was said to provide insight into the needs of patients with wounds and provide a roadmap for structuring future clinical trials. This may be true, but still this survey does not clearly relate to the policy at hand. It is very difficult to accept a claim that quality of life or progression of wound measures can supersede or replace actual wound healing. Overall, Palmetto GBA remains concerned with the lack of large, randomized controlled trials and/or applicable Level I evidence related to these spectroscopy services. We continue to believe that non-coverage for non-contact near-infrared spectroscopy use in acute or chronic wound assessment and management and for use in flap or micro-flap assessment intra- or post- operatively remains warranted.

Lastly, in response to this commenter, pending studies with preliminary results cannot be currently utilized as an evidence basis relevant to this policy. However, evolving evidence will be followed. Reconsideration of the non-coverage policy can be entertained if sufficient applicable evidence-based literature is published.

I am a wound care physician and wound care medical director. I am quite familiar with the outpatient, inpatient, and post-acute wound care practices and have my own wound care practice. I am making my voice heard to not only you but to my MAC jurisdiction in Nevada. I have become aware that your Medical Policy team has proposed a non-payment local coverage determination for the Near Infrared Spectroscopy technology, Proposed LCD DL39385. I would respectfully request your assistance in changing the policy.

My practice includes the treatment of many Medicare beneficiaries with chronic wounds and ulcers. Chronic Wound Care is a “Chronic Medical Disease” that requires a multidisciplinary approach. Due to the necessity of multiple medical specialties in wound care, it is imperative to include innovation and technology to assist in standardizing wound management. This standardization is needed amongst different medical specialists and between providers of the same specialty. Near Infrared Technology is one of those innovations that has allowed us to visualize improvements in the wound beyond simple length and width. Basic Visual cues alone do not allow the provider, nor the patient, sufficient data to understand if the wound is healing. NIR allows providers to assess the tissue perfusion/oxygenation in the wound bed (StO2), which is critical to optimizing wound care treatment plans. It allows us to see if there is enough skin tissue perfusion to heal the wound. If there is a lack of oxygenation it is a direct correlation to impaired wound healing.

NIRS, specifically the Snapshot_NIR^® from Kent Imaging, has become an integral part of my practice, and allowed us to make more informed decisions regarding the treatment of my patients both in inpatient and outpatient.

We use it to communicate with other physicians such as vascular surgeons, plastic surgeons, cardiovascular specialists, and other wound care providers. It helps guide our decision tree. If there is low tissue perfusion, it prompts the provider to investigate the potential causes of this. NIR technology is unique in that it allows us to see if the tissue is receiving enough “oxygen” not just “blood flow.”. Potential causes of low tissue oxygenation include anemia, hypoxemia, compartment syndrome, hypotension, poor cardiac output, vascular shunting, excessive tissue tension, and vascular compromise, amongst many other diagnoses. In contrast to arterial ultrasound, or angiography, which only shows if there is a direct macrovascular compromise to the limb.

Appropriate utilization of therapeutic modalities is absolutely needed to be fiscally and ethically responsible. I have used Snapshot_NIR^® before and after the application of cellular or tissue-based products to ensure that the product is improving the wound bed and achieving the desired outcome. NIR has shown benefits when utilizing hyperbaric oxygen. NIR can help to identify which patients may benefit from hyperbaric oxygen and if the patient is responding to the treatment which can prevent overutilization.

In conclusion, utilization of the Snapshot_NIR^® has allowed all the providers in my practice to communicate with specific data on a patient and create meaningful benchmarks to heal the wound. It is imperative to standardize algorithmic approach to chronic wounds. I hope the technology will become part of the gold standard in wound assessment modalities. I again respectfully request that you re-consider your policy on Near Infrared Technology.

Thank you for your informed comments. No additional data or evidence-based literature was submitted by this commenter. It is not clear how much standardization is truly achieved with SnapshotNIR^® as spectroscopy obtained results are conveyed back and forth between providers nor how/when spectroscopic images change practice. There is no available randomized control trial evidence that conveys what positive outcomes are achieved and/or changed therapeutic decisions directly related to this spectroscopy service. No evidence was submitted to demonstrate how well wound spectroscopy truly guides hyperbaric oxygen treatment decisions. Any benchmarks achieved via the use of wound/flap spectroscopy are not evidence-supported or publicized in a credible consensus fashion. Until further prospective randomized control trials are done, this FDA cleared oximetry device may be used, but will not be covered for any separate defined payment.

I have been a Wound Care Specialist for 29 years in Arizona, both in a hospital outpatient wound center and in my private practice setting. I have become aware that your Medical Policy team has proposed a non-payment local coverage determination for the Near Infrared Spectroscopy technology, Proposed LCD DL39385. I am in favor of your position to not provide coverage for NIRS utilized within your jurisdictions.

My practice includes the treatment of many Medicare beneficiaries with chronic wounds and ulcers. As you are aware, many of these patients are at risk for complications resulting in hospitalization and/or amputation. I have utilized NIRS, specifically the Snapshot_NIR^® from Kent Imaging, but it has not become an integral part of my practice, nor can I anticipate that it will for me or for many of the private practices and or hospital settings. Although it provides interesting skin perfusion or oxygenation levels at “bedside” I do not specifically need this information to make an informed decision regarding the treatment of my patients. I do believe that early interventions, such as vascular referral in patients with Critical Limb Threatening Ischemia, which can prevent significant tissue compromise and prevent limb loss, this has been accomplished for over the 29-30 years of my practice with my clinical judgement and medical knowledge. The true test of perfusion is arterial duplex studies which is well documented in literature. I have published and lectured on this topic in many settings and those clinicians who only “dabble” in wound care jump at the first technology that can allow them to bill for more services, which often times does not add significantly to the care of the patient. Monitoring wound improvement by clinical findings and then responding to these findings is the standard and more importantly is in the responding to the assessment and finding. What is happening however is that even wound measurements are not being strictly adhered to and or taken into consideration as to response. Most clinicians look at the wound and then judge that it is making progress without use of any objective criteria. So, in that vein, I don’t see that any new technology, especially costly technology in the hands of clinicians who claim to be wound care doctors – only because they can “pick up “shift or two to monitor Hyperbaric therapy and generate more “easy income” – I think that we are spending our tax dollars inefficiently. The ability to assess the wound response to my treatment plan is based on my monitoring my patients as often as indicated by the medical findings and then responding more quickly to changes in patient conditions and has resulted in an overall decrease in the number of visits needed to achieve the desired outcomes without the use of NIR imaging device.

I have not needed the use of NIR for example when using Cellular and/or Tissue based Products. NIR is not needed to determine success of TBP, this aspect of wound care is also mismanaged, clinicians with little knowledge of cellular activities and wound healing progress are over utilizing Cellular or Tissue based products – on the recommendation of company representatives and Hospital wound programs that emphasis procedures to increase income for the hospital, instead of clinical findings. The wounds should be cultured prior to use of tissue substitutes so that these products have the best chance of working. If there is a concern of tissue perfusion then a full vascular workup and consult with vascular surgeon is best to optimize wound healing and not purely basing it on the images obtained by NIR. I am also able to determine lack of response without the need of imaging by purely being the best clinician and making the clinical judgement my education has provided to me. When using Hyperbaric Oxygen Therapy (HBOT) NIRS may allow for evaluation of the patient response to oxygen challenge and initial HBO treatment which can help to select which patients may benefit from HBOT and which are not candidates. However, many patients with diabetic foot ulcers who are placed in Hyperbaric therapy do not require this modality for the small toe ulcer that they may have. These small ulcers at the tips of toes are often best and quickly treated with small surgeries when appropriate to remove the exposed bone and soft tissue and off load the pressure with inserts and shoes rather than HBOT that continues for far too long.

I make these comments as I have seen wound care become a business, rather than benefiting patient it benefits hospital wound centers and are costly to patients and to the system without significant improvements in care. For these reasons I no longer will work in a hospital wound center, I treat all of my wound patients in the office, where they do not have to pay a facility fee, they get the same care, and I am not hand tied with unreasonable formularies that compensate the hospital first with back ended deals made with vendors. I have seen too much abuse and overutilization, and many of the clinicians who work in wound centers do not even take the time to become certified in wound care, they do this as a “side hustle” to their emergency room or primary care work. Patients are not getting the adequate care they need.

I have experience not just as a clinician, but unfortunately my husband who has diabetes and developed a toe ulcer was victim to this predatory practice at a local outpatient wound center. I was not able to treat him due to conflict of interest and when I sent him to what I believed to be a wound center with a clinician who called herself a wound care specialist my husband lost his toe, because they wanted him to have HBOT rather taking him to surgery and removing the tip of the toe that had a bone infection. It was poor care for the sake of revenues, the clinician did not even take into consideration his CHF, and HBOT has a relative contraindication, that when I approached her with this, she felt it was fine until then my husbanded was hospitalized due to fluid overload with worsening CHF. Clinicians who are not wound certified or taken the time to even go to a wound symposium yearly to keep up should not be doing wound care just because they have an MD or DO or DPM degree. It is even worse with NP’s. Many of these clinicians are not credentialed to perform surgery so they don’t, and patients don’t get the best care in a timely fashion.

I would rather see in future such things as tissue biomarkers and MMP test kits that can be used at chair side to assist with the care we provide to patient and be able to target the care provided more accurately.

Thank you for your informed comments. We appreciate your time in participating in the valuable comment process.

I am a Plastic Surgeon/wound care specialist. My practice includes the treatment of many Medicare beneficiaries with chronic wounds and ulcers as well as reconstructive surgical procedures and Hyperbaric Oxygen Therapy. As you are aware, many of these patients are at risk for complications resulting in hospitalizations, secondary surgeries and/or amputations. NIRS, specifically the Snapshot from Kent Imaging has become an integral part of my practice and allowed me to make more informed decisions regarding the treatment of my patients. I have been better able to provide appropriate care and also eliminate unnecessary care based upon the information that the Kent Imaging SnapshotNIR has provided. This includes deciding when hyperbaric oxygen therapy might be beneficial for comprised flaps or when it may not be indicated based on the interpretation of the oxygen saturation values. Without the use of NIRS, I have patients who might have been subjected to costly and time intensive therapies, but the information provided by SnapshotNIRS allowed me to evaluate and appropriately decide that a costly intervention was not needed. In the operating room it has become an essential aid in determining flap viability, potentially preventing a costly reoperation and the mental anguish that patients might experience with a complication and a longer, more costly recovery.

Evidence supports the use of this device in reconstructive surgery and limb salvage.

In closing, I respectfully request that your policy provide reimbursement for NIRS technology. It is a benefit for your beneficiaries and based upon my experience has proven to both the care and quality of life for my patients.

Thank you for your informed comments. No additional evidence-based literature was presented for review regarding claims that wound spectroscopy services facilitate hyperbaric oxygen therapy candidacy in a meaningful fashion or that intra-operative flap viability is reliably assessable and then directly attributable to improved health outcomes in a statistically significant fashion. Palmetto GBA does not find this comment persuasive in and of itself toward allowing coverage with separate payment for this FDA cleared oximetry device.

Thank you for the opportunity to comment on the Proposed LCD for Near Infrared Spectroscopy. I am the Clinical Nurse Manager in MO. I have become aware that your Medical Policy team has proposed a non-payment local coverage determination for the Near Infrared Spectroscopy technology, Proposed LCD DL39385. I strongly urge you to reconsider your position and provide appropriate payment for NIRS utilized within your jurisdictions.

My medical providers practice includes the treatment of many Medicare beneficiaries with chronic wounds and ulcers. As you are aware, many of these patients are at risk for complications resulting in hospitalization and/or amputation. NIRS, specifically the Snapshot_NIR^® from Kent Imaging, has become an integral part of my medical providers practice, and allows them to make more informed decisions regarding the treatment of their patients. The utilization of the Snapshot_NIR^® has allowed them to evaluate the tissue perfusion/oxygenation in the wound bed (StO2). This is critical to optimizing wound care treatment plans, especially implementing early interventions, such as vascular referral in patients with Critical Limb Threatening Ischemia. Early treatment can prevent significant tissue compromise and prevent limb loss. The ability to assess the wound response to their treatment plan has given them the information needed to respond more quickly to changes in patient conditions and has resulted in an overall decrease in the number of visits needed to achieve the desired outcomes.

Utilization of the NIR technology has allowed my medical providers to more efficiently manage the utilization of expensive advanced therapies. When using Cellular and/or Tissue based Products my medical providers can assess for adequate tissue perfusion and viability to ensure optimization of wound bed condition prior to application, which enhances graft outcomes. They are also able to determine when to discontinue therapy when patient shows lack of response, or when patient has reached the maximum medical benefit or improvement. When using Hyperbaric Oxygen Therapy (HBOT) NIRS allows evaluation of the patient response to oxygen challenge and initial HBO treatment which can help to select which patients may benefit from HBOT and which are not candidates. NIRS can also be used to assess and document tissue oxygenation throughout the treatment process; this allows my medical providers to discontinue therapy when the maximum medical benefit or improvement has been achieved.

Evidence supports the use of the device in reconstructive surgery, chronic wound care among other areas of interest. The evidence available shows that looking at trends in the images can be predictive and assist in clinical decision making. One example can be found in the paper by Temple-Oberle in 2020 showed that in 42 patients Snapshot was able to distinguish between areas at risk that went on to heal and areas that ultimately went on to develop skin flap necrosis. The paper is entitled “Intraoperative Near-infrared Spectroscopy Correlates with Skin Flap Necrosis: A Prospective Cohort Study” and can be found on PubMed.

Furthermore, in chronic wounds, there is literature to support that trends in StO2 provided by Snapshot can be predictive of healing vs non- healing wounds. In the 2020 randomized controlled trial by L’Abbate they found that “A significant feature in our study is the sharp drop in the StO2 signal with healing wounds as opposed to the lack of changes with wounds refractory to treatment”. This study enrolled 81 patients and is entitled “Potential markers of healing from near infrared spectroscopy imaging of venous leg ulcer. A randomized controlled clinical trial comparing conventional with hyperbaric oxygen treatment” and is available on PubMed."

My medical providers and wound care clinic are a part of a large multi hospital system that found the technology to be so valuable that it has assigned 2.67 RVUs for my medical providers to who utilize it. I am also aware that WPS reimburses this technology.

Using Snapshot is comparable to obtaining an MRI, CT or Duplex Ultrasound or to obtaining intraoperative images with SPY. The NIRS images are obtained and then interpreted by the clinician based on the patient variables and well as the wound status (similar to a radiologist reading of an x-ray). NIRS imaging does not provide a single numerical value of oxygenation, such as with pulse oximetry. Rather NIRS imaging provides a comprehensive evaluation of St02 of the area of concern, showing angiosomal perfusion, as well as levels of oxygenated and deoxygenated hemogloblin, with all of these data points requiring interpretation and correlation to the patient ultimately guiding clinical decision making.

I would also urge you to consider comparable technologies (such as Moleculite) currently reimbursable within your jurisdictions while evaluating this proposed LCD.

Moleculight (0598T)

• Both technologies are images obtained through the use of Near Infrared technology
• Both involve bedside testing with camera imaging
• Both technologies provide immediate and actionable data for providers and staff impacting the plan of care real time
• Both require clinical interpretation to guide clinical decision making
• Image acquisition procedure is essentially the same for both the Moleculight device and the Snapshot_NIR®

SPY ICG Angiography (92242)

• Both technologies are images obtained through the use of Near Infrared technology
• Both involve bedside testing with camera imaging
• Both technologies provide immediate and actionable data for providers and staff impacting the plan of care real time
• Both require clinical interpretation to guide clinical decision making

In closing, I respectfully request that your policy provide reimbursement for NIRS technology. It is beneficial for your beneficiaries, and based upon my experience, has proven to improve both the care, and the quality of life for my patients.

Thank you for your informed comments. Multiple applications for Snapshot spectroscopy were mentioned. Wound spectroscopy may evaluate the tissue perfusion/oxygenation in a wound bed, but it is not clear via strong randomized, controlled evidence that vascular referral patterns are notably changed or that the service itself contributes anything toward wound bed optimization prior to cellular- or tissue-based products. No strong evidence-based literature has been identified that confirms claims that wound or flap spectroscopy changes wound care management or health outcomes as compared to long standing wound care practices. Two literature references embedded within the comment were reviewed. Temple Oberle et al. attempted to look at the impact of spectroscopy with various flaps intraoperatively, but it was not entirely clear how the tissue oxygen saturations changed intraoperative management as compared to more usual direct visual assessment or with other assessment tools. The authors admitted the study was tremendously underpowered and was done with a demographic younger than the standard Medicare population. Standardized approaches accounting for skin color and other types of artifacts were not clearly explained and seemed to be in evolution. Near-infrared (NIR) spectroscopy was able to detect vascular compromise earlier than physical examination and venous Doppler findings, but it was not clear that clinical management was substantially changed or that ultimate outcomes were notably different than what they would have been without spectroscopy. The study noted that further research was needed to understand the full potential of intraoperative NIR spectroscopy. Also, the 2^nd reference (L’Abbate) was reviewed though only the abstract could be accessed. As in many other studies, NIRS analysis of tissue oxygenation in wounds could be done and could potentially predict healing, but again, it was not clear how the prediction definitively changed management going forward. The treatments used were variable and the paper was industry sponsored. Palmetto GBA believes evidence-based medicine can and should drive the practice of medicine. Given a lack of strong, prospective, randomized controlled trials for this therapy within an amply available group of beneficiaries, coverage cannot currently be extended to this spectroscopy service.

This non-coverage policy is specific to wounds and flaps and does not speak to other services.

As a plastic surgeon who has been involved in wound care management and breast reconstruction for nearly 40 years, I would like to endorse the application for NIRS reimbursement in clinical practice. I was involved with the development of the SPY technology using Indocyanine green marketed first by Novadaq and then Stryker and have found the more recently available NIRS handheld cameras (Kent Snapshot) to be more accurate, much more convenient, and far less expensive to use. The devices cost a fraction of the SPY device, do not involve an invasive intravenous injection of ICG dye and produce results which are reproducible, very reliable and correlate well with clinical outcomes in both mastectomy flaps as well as in skin and soft tissue flaps used elsewhere for reconstruction. In my own practice I had completely substituted this device to replace the SPY-ICG based technology as it is much more cost-effective and simpler to use. I am in the process of publishing several papers confirming the clinical outcomes with this device and would strongly urge MACS to reimburse the use of these devices for clinical practice in both flat management and in chronic wound care.

Thank you for your informed comment. No evidence-based medical data was submitted although this commenter apparently does conduct research and hopes to speak to clinical outcomes in the future. The commenter notes spectroscopy results to be reproducible, reliable and correlating well with clinical outcomes, but no data is offered to support these claims. Again, it is not made clear how any predictive powers of spectroscopy actually change clinical management or impact ultimate outcomes. Given a lack of strong, prospective, randomized controlled trials for this therapy within an amply available group of beneficiaries, coverage cannot currently be extended to this spectroscopy service.

Thank you for the opportunity to comment on the Proposed LCD for Near Infrared Spectroscopy. I am in a group practice in Louisiana, and we have found Near Infrared Spectroscopy technology, specifically the Snapshot_N1R^® from Kent Imaging, to be extremely beneficial in the evaluation and management of our patients. NIR allowed me to make more informed decisions regarding the treatment of my patients. The utilization of the Snapshot_N1R^® has allowed me to evaluate-the tissue perfusion/oxygenation in the wound bed and better navigate treatment options.

I strongly urge you to reconsider your position and provide appropriate payment for NIRS utilized within your jurisdictions. I have become aware that your Medical Policy team has proposed a non-payment local coverage determination for the Near Infrared Spectroscopy technology, Proposed LCD DL39385. I strongly urge you to reconsider your position and provide appropriate payment for NIRS utilized within your jurisdiction.

My practice includes the treatment of many Medicare beneficiaries with chronic wounds and ulcers. As you are aware, many of these patients are at risk for complications resulting in hospitalization and/or amputation. Utilization of the NIR technology has allowed me to more efficiently manage the utilization of expensive advanced therapies.

In chronic wounds, there is literature to support that trends in St02 provided by Snapshot can be predictive of healing vs non- healing wounds. In the 2020 randomized controlled trial by L' Abbate they found that "A significant feature in our study is the sharp drop in the St02 signal with healing wounds as opposed to the lack of changes with wounds refractory to treatment.” This study enrolled 81 patients and is entitled "Potential markers of healing from near infrared spectroscopy imaging of venous leg ulcer. A randomized controlled clinical trial comparing conventional with hyperbaric oxygen treatment" and is available on PubMed.

I would also urge you to consider comparable technologies (such as Moleculite) currently reimbursable within your jurisdictions while evaluating this proposed LCD.

Moleculight (0598T)

• Both technologies are images obtained through the use of Near Infrared technology
• Both involve bedside testing with camera imaging
• Both technologies provide immediate and actionable data for providers and staff impacting the plan of care real time
• Both require clinical interpretation to guide clinical decision making
• Image acquisition procedure is essentially the same for both the Moleculight device and the Snapshot_N1R^®

SPY ICG Angiography (92242)

• Both technologies are images obtained through the use of Near Infrared technology
• Both involve bedside testing with camera imaging
• Both technologies provide immediate and actionable data for providers and staff impacting the plan of care real time
• Both require clinical interpretation to guide clinical decision making

In closing, I respectfully request that your policy provide reimbursement for NIRS technology. It is beneficial for your beneficiaries, and based upon my experience, has proven to improve both the care, and the quality of life for my patients.

This comment is very similar to comment #5 above. Please see response #5.

Thank you for the opportunity to comment on the Proposed LCD for Near Infrared Spectroscopy. I am a Pediatric Surgeon and I have been in business for over 15 years. Near Infrared Spectroscopy has changed the way I practice medicine. As a podiatrist I am constantly faced with patients with PVD.

Utilization of the NIR technology has allowed me to more efficiently-manage the utilization of expensive advanced therapies. For example, when using Cellular and/or Tissue based Products I can assess for adequate tissue perfusion and viability to ensure optimization of wound bed condition prior to application, which enhances graft outcomes. I am also able to determine when to discontinue therapy when patient shows lack of response, or when patient has reached the maximum benefit. I have become aware that your Medical Policy team has proposed a non-payment local coverage determination for the Near Infrared Spectroscopy technology, Proposed LCD DL39385. I strongly urge you to reconsider your position and provide appropriate payment for NIRS utilized within your jurisdictions.

My practice includes the treatment of many Medicare beneficiaries with chronic wounds and ulcers. As you are aware, many of these patients are at risk for complications resulting in hospitalization and/or amputation, NIRS, specifically the Snapshot_NIR^® from Kent Imaging, has become an integral part of my practice, and allowed me to make more informed decisions regarding the treatment of my patients. The utilization of the Snapshot_NIR^® has allowed me to evaluate the tissue perfusion/oxygenation in the wound bed. I am also aware that WPS has chosen to reimburse this technology, and that a large multi hospital system has found the technology to be so valuable that it has assigned 2.7 RVUs for its employed physicians who utilize it.

Using Snapshot is comparable to obtaining an MRI, CT or Duplex Ultrasound or to obtaining intraoperative images with SPY. The NIRS images are obtained and then interpreted by the clinician based on the patient variables and well as the wound status (similar to a radiologist reading of an x-ray). NIRS imaging does not provide a single numerical value of oxygenation, such as with pulse oximetry. Rather NIRS imaging provides a comprehensive evaluation of St02 of the area of concern, showing angiosomal perfusion, as well as levels of oxygenated and deoxygenated hemogloblin, with all of these data points requiring interpretation and correlation to the patient ultimately guiding clinical decision making.

Thank you for your informed comment. No additional evidence-based medical data was submitted. Given a lack of strong, prospective, randomized controlled trials for this therapy within an amply available group of beneficiaries, coverage cannot currently be extended to this spectroscopy service.

I am a board-certified podiatrist in LA. I am a wound care specialist at our clinic and have found the NIR technology extremely useful in my practice. I have become aware that your Medical Policy team has proposed a non-payment local coverage determination for the Near Infrared Spectroscopy technology, Proposed LCD DL39385. I strongly urge you to reconsider your position and provide appropriate payment for NIRS utilized within your jurisdictions.

As a Wound Care Specialist, I can vouch for its effectiveness. I have become aware that your Medical Policy team has proposed a non-payment local coverage determination for the Near Infrared Spectroscopy technology, Proposed LCD DL39385. As an active provider of wound care services, I strongly urge you to reconsider your position and provide appropriate payment for NIRS utilized within your jurisdictions.

My practice includes the treatment of many Medicare beneficiaries with chronic wounds and ulcers. As you are aware, many of these patients are at risk for complications resulting in hospitalization and/or amputation NIRS, specifically the Snapshot_NIR^® from Kent Imaging, has become an integral part of my practice, and allowed me to make more informed decisions regarding the treatment of my patients. The utilization of the Snapshot_NIR^® has allowed me to evaluate the tissue perfusion/oxygenation in the wound bed (St02), which is critical to optimizing wound care treatment plans, especially implementing early interventions, such as vascular referral in patients with Critical Limb Threatening lschemia, which can prevent significant tissue compromise and prevent limb loss. The ability to assess the wound response to my treatment plan has given me the information needed to respond more quickly to changes in patient conditions and has resulted in an overall decrease in the number of visits needed to achieve the desired outcomes.

Utilization of the NIR technology has allowed me to more efficiently manage the utilization of expensive advanced therapies. For example, when using Cellular and/or Tissue based Products I can assess for adequate tissue perfusion and viability to ensure optimization of wound bed condition prior to application, which enhances graft outcomes. I am also able to determine when to discontinue therapy when patient shows lack of response, or when patient has reached the maximum benefit. When using Hyperbaric Oxygen Therapy (HBOT) NIRS allows evaluation of the patient response to oxygen challenge and initial HBO treatment which can help to select which patients may benefit from HBOT and which are not candidates. NIRS can also be used to assess and document tissue oxygenation throughout the treatment process, allowing us to discontinue therapy when the maximum benefit has been achieved.

Evidence supports the use of the device in reconstructive surgery, chronic wound care among other areas of interest. The evidence available shows that looking at trends in the image scan be predictive and assist in clinical decision making. One example can be found in the paper by Temple-Oberle in 2020 showed that in 42 patients Snapshot was able to distinguish between areas at risk that went onto heal and areas that ultimately went onto develop skin flap necrosis. The paper is entitled "lntraoperative Near-infrared Spectroscopy Correlates with Skin Flap Necrosis: A Prospective Cohort Study" and can be found on PubMed.

Furthermore, in chronic wounds, there is literature to support that trends in StO2 provided by Snapshot can be predictive of healing vs non- healing wounds. In the 2020 randomized controlled trial by L'Abbate they found that "A significant feature in our study is the sharp drop in the StO2 signal with healing wounds as opposed to the lack of changes with wounds refractory to treatment.” This study enrolled 81 patients and is entitled "Potential markers of healing from near infrared spectroscopy imaging of venous leg ulcer. A randomized controlled clinical trial comparing conventional with hyperbaric oxygen treatment" and is available on PubMed.

I am also aware that WPS has chosen to reimburse this technology, and that a large multi hospital system has found the technology to be so valuable that it has assigned 2.7 RVUs for its employed physicians who utilize it.

Using Snapshot is comparable to obtaining an MRI, CT or Duplex Ultrasound or to obtaining intraoperative images with SPY. The NIRS images are obtained and then interpreted by the clinician based on the patient variables as well as the wound status (like a radiologist reading of an x-ray). NIRS imaging does not provide a single numerical value of oxygenation, such as with pulse oximetry. Rather NIRS imaging provides a comprehensive evaluation of St02 of the area of concern, showing angiosomal perfusion, as well as levels of oxygenated and deoxygenated hemogloblin, with all of these data points requiring interpretation and correlation to the patient ultimately guiding clinical decision making.

I would also urge you to consider comparable technologies (such as Moleculite) currently reimbursable within your jurisdictions while evaluating this proposed LCD.

Moleculight (0598T)

• Both technologies are images obtained through the use of Near Infrared technology
• Both involve bedside testing with camera imaging
• Both technologies provide immediate and actionable data for providers and staff impacting the plan of care real time
• Both require clinical interpretation to guide clinical decision making
• Image acquisition procedure is essentially the same for both the Moleculight device and the Snapshot_N1R^®

SPY ICG Angiography (92242)

• Both technologies are images obtained through the use of Near Infrared technology
• Both involve bedside testing with camera imaging
• Both technologies provide immediate and actionable data for providers and staff impacting the plan of care real time
• Both require clinical interpretation to guide clinical decision making

In closing, I respectfully request that your policy provide reimbursement for NIRS technology. It is beneficial for your beneficiaries, and based upon my experience, has proven to improve both the care, and the quality of life for my patients.

This comment is very similar to comment #5 above. Please see response #5.

I am writing this letter to comment on the proposed non-payment local coverage determination for the Near Infrared Spectroscopy technology, Proposed LCD DL39385. I am a podiatrist practicing in Louisiana and wound care is my passion. I strongly urge you to reconsider your position and provide appropriate payment for NIRS utilized within your jurisdictions. I have become aware that your Medical Policy team has proposed a non-payment local coverage determination for the Near Infrared Spectroscopy technology, Proposed LCD DL39385. I strongly urge you to reconsider your position and provide appropriate payment for NIRS utilized within your jurisdictions.

My practice includes the treatment of many Medicare beneficiaries with chronic wounds and ulcers. As you are aware, many of these patients are at risk for complications resulting in hospitalization and/or amputation. NIRS, specifically the Snapshot_NIR^® from Kent Imaging, has become an integral part of my practice, and allowed me to make more informed decisions regarding the treatment of my patients. The utilization of the Snapshot_NIR^® has allowed me to evaluate the tissue perfusion/oxygenation in the wound bed (St02), which is critical to optimizing wound care treatment plans, especially implementing early interventions, such as vascular referral in patients with Critical Limb Threatening lschemia, which can prevent significant tissue compromise and prevent limb loss.

Utilization of the NIR technology has allowed me to more efficiently-manage the utilization of expensive advanced therapies. For example, when using Cellular or Tissue based products, I can assess for adequate tissue perfusion and viability to ensure optimization of wound bed condition prior to application, which enhances graft outcomes. I am also able to determine when to discontinue therapy when patient shows lack of response, or when patient has reached the maximum benefit. When using Hyperbaric Oxygen Therapy (HBOT) NIRS allows evaluation of the patient response to oxygen challenge and initial HBO treatment which can help to select which patients may benefit from HBOT and which are not candidates. NIRS can also be used to assess and document tissue oxygenation throughout the treatment process, allowing us to discontinue therapy when the maximum benefit has been achieved.

Evidence supports the use of the device in chronic wound care among other areas of interest. The evidence available shows that looking at trends in the images can be predictive and assist in clinical decision making. One example can be found in the paper by Temple-Oberle in 2020 showed that in 42 patients Snapshot was able to distinguish between areas at risk that went on to heal and areas that ultimately went on to develop skin flap necrosis. The paper is entitled "lntraoperative Near-infrared Spectroscopy Correlates with Skin Flap Necrosis: A Prospective Cohort Study" and can be found on PubMed.

This comment is very similar to comment #5 above. Please see response #5.

I am the owner operator in LA. We perform a lot of wound care at our facility and have found NIR technology invaluable.

I have become aware that your Medical Policy team has proposed a non-payment local coverage determination for the Near Infrared Spectroscopy technology, Proposed LCD DL39385. I strongly urge you to reconsider your position and provide appropriate payment for NIRS utilized within your jurisdictions.

I am a Certified Wound Care Specialist and I can vouch for its effectiveness I have become aware that your Medical Policy team has proposed a non-payment local coverage determination for the Near Infrared Spectroscopy technology, Proposed LCD DL39385. As an active provider of wound care services, I strongly urge you to reconsider your position and provide appropriate payment for NIRS utilized within your jurisdictions.

My practice includes the treatment of many Medicare beneficiaries with chronic wounds and ulcers. As you are aware, many of these patients are at risk for complications resulting in hospitalization and/or amputation. NIRS, specifically the Snapshot_NIR^® from Kent Imaging, has become an integral part of my practice, and allowed me to make more informed decisions regarding the treatment of my patients. The utilization of the Snapshot_NIR^® has allowed me to evaluate the tissue perfusion/oxygenation in the wound bed (StO2), which is critical to optimizing wound care treatment plans, especially implementing early interventions, such as vascular referral in patients with Critical Limb Threatening lschemia, which can prevent significant tissue compromise and prevent limb loss. The ability to assess the wounds response to my treatment plan has given me the information needed to respond more quickly to changes in patient’s conditions and has resulted in an overall decrease in the number of visits needed to achieve the desired outcomes.

Utilization of the NIR technology has allowed me to more efficiently manage the utilization of expensive advanced therapies.

Evidence supports the use of the device in reconstructive surgery, chronic wound care among other areas of interest. The evidence available shows that looking at trends in the images can be predictive and assist in clinical decision making. One example can be found in the paper by Temple-Oberle in 2020 showed that in 42 patients Snapshot was able to distinguish between areas at risk that went onto heal and areas that ultimately went on to develop skin flap necrosis. The paper is entitled "lntraoperative Near-infrared Spectroscopy Correlates with Skin Flap Necrosis: A Prospective Cohort Study" and can be found on PubMed.

Furthermore, in chronic wounds, there is literature to support that trends in St02 provided by Snapshot can be predictive of healing vs non- healing wounds. In the 2020 randomized controlled trial by L'Abbate they found that "A significant feature in our study is the sharp drop in the St02 signal with healing wounds as opposed to the lack of changes with wounds refractory to treatment". This study enrolled 81 patients and is entitled "Potential markers of healing from near infrared spectroscopy imaging of venous leg ulcer. A randomized controlled clinical trial comparing conventional with hyperbaric oxygen treatment" and is available on PubMed.

I would also urge you to consider comparable technologies (such as Moleculite) currently reimbursable within your jurisdictions while evaluating this proposed LCD.

Moleculight (0598T)

• Both technologies are images obtained through the use of Near Infrared technology
• Both involve bedside testing with camera imaging
• Both technologies provide immediate and actionable data for providers and staff impacting the plan of care real time
• Both require clinical interpretation to guide clinical decision making
• Image acquisition procedure is essentially the same for both the Moleculight device and the Snapshot_N1R^®

SPY ICG Angiography (92242)

• Both technologies are images obtained through the use of Near Infrared technology
• Both involve bedside testing with camera imaging
• Both technologies provide immediate and actionable data for providers and staff impacting the plan of care real time
• Both require clinical interpretation to guide clinical decision making

In closing, I respectfully request that your policy provide reimbursement for NIRS technology. It is beneficial for your beneficiaries, and based upon my experience, has proven to improve both the care, and the quality of life for my patients.

This comment is very similar to comment #5 above. Please see response #5.

I am writing to comment on the Proposed LCD for Near Infrared Spectroscopy. I am a podiatric surgeon specializing in rearfoot/reconstructive surgery. I have become aware that your Medical Policy team has proposed a non-payment local coverage determination for the Near Infrared Spectroscopy technology, Proposed LCD DL39385. I strongly urge you to reconsider your position and provide appropriate payment for NIRS utilized within your jurisdictions.

My practice includes the treatment of many Medicare beneficiaries with chronic wounds and ulcers. As you are aware, many of these patients are at risk for complications resulting in hospitalization and/or amputation. NIRS, specifically the Snapshot_NIR^® from Kent Imaging, has become an integral part of my practice, and allowed me to make more informed decisions regarding the treatment of my patients. The utilization of the Snapshot_NIR^® has allowed me to evaluate the tissue perfusion/oxygenation in the wound bed (StO2), which is critical to optimizing wound care treatment plans, especially implementing early interventions, such as vascular referral in patients with Critical Limb Threatening lschemia, which can prevent significant tissue compromise and prevent limb loss.

This technology has also allowed me to determine the exact location where blood flow is compromised. This allows me to perform foot and lower leg amputation, only taking the ischemic portion of the limb. This might be the difference between amputation of the forefoot vs. the entire foot. This difference has a huge impact on the patient's quality of life and eliminates the need for a prosthesis.

Evidence based medicine supports the use of the device in reconstructive surgery, chronic wound care among other areas of interest. The evidence available shows that looking at trends in the images can be predictive and assist in clinical decision making.

Thank you for your informed comment. Evidence based medicine support for the use of this spectroscopy device is said to exist, but no additional such literature was provided for review. Spectroscopy imaging may be predictive, but it is not clear that subsequent impact on clinical management decisions is compelling or any different than what would have occurred with standard monitoring and assessment. Given a lack of strong, prospective, randomized controlled trials for this therapy within an amply available group of beneficiaries, coverage cannot currently be extended to this spectroscopy service.