Response to Comments: Superficial Radiation Therapy (SRT) for the Treatment of Nonmelanoma Skin Cancers (NMSC)

Comments were received from a radiation oncologist and medical director of medical benefits management expressing strong agreement with the policy’s position that high-resolution ultrasound (HRUS) is not necessary for the delivery of superficial radiation therapy (SRT).
The commenter stated that clinical evidence does not validate HRUS as a requirement in planning or guiding treatments for nonmelanoma skin cancers (NMSC), nor does it demonstrate benefits in enhancing outcomes such as local control or cosmetic improvements.
Incorporating HRUS into SRT was described as likely to increase costs and complexity unnecessarily, without any proven patient benefits.
The policy was commended for setting a prudent precedent by recommending against the integration of technologies lacking robust support from medical literature and expert consensus.
The commenter also supported the policy’s framework for when SRT is covered, noting that it ensures access to therapy for patients who are unsuitable candidates for surgery or prefer non-invasive alternatives, and reflects contemporary clinical practices.

Thank you for your support of the policy and evidence-based decision making. We appreciate your careful review and thoughtful feedback.

Comments were received from a medical device manufacturer expressing general agreement with the proposed conditions for SRT patient eligibility and provider qualifications, but opposing the recommendation to exclude high-frequency ultrasound (HFUS) from SRT treatment.
The commenter emphasized that HFUS enables accurate assessment of lesion depth, which is critical for applying the ALARA (As Low As Reasonably Achievable) principle in radiation therapy.
They stated that HFUS allows physicians to treat to the minimal depth needed, reducing unnecessary exposure and improving safety.
The commenter acknowledged limitations in existing clinical studies but maintained that HFUS remains a valuable tool for initial simulation and treatment monitoring.
They urged continued allowance for HFUS use in SRT, emphasizing its role in enhancing treatment precision and patient outcomes.

Thank you for your comments. Upon review of the literature, the quality of evidence is low to support the use of high-frequency ultrasound (HFUS) with each superficial radiation therapy (SRT).
There are no validated protocols for assessing tumor depth by ultrasound nor correlation of ultrasound tumor depth with microscopic tumor invasion.
There is no evidence to support that the addition of HFUS to SRT is required for the treatment of low-risk basal cell carcinoma (BCC) or squamous cell carcinoma (SCC). Comparative safety and effectiveness of HFUS-guided SRT cannot be determined due to high risk of bias in available studies and lack of direct comparisons with standard care.
Prospective studies comparing HFUS-guided SRT and surgery in well-matched patient groups are needed to draw conclusions on comparative outcomes.

Comments were received in opposition to the proposed Local Coverage Determination (LCD) on Superficial Radiation Therapy (SRT) for Nonmelanoma Skin Cancers (NMSC). These comments were submitted by beneficiaries and expressed support for their current treatment with Image-Guided Superficial Radiation Therapy (IGSRT). The letters emphasized the importance of maintaining access to IGSRT, citing personal treatment experiences, high success rates, and the value of non-invasive options for elderly or high-risk patients.

Thank you for your comments. See response to comment #2. The proposed local coverage determination Superficial Radiation Therapy (SRT) for the Treatment of Nonmelanoma Skin Cancers (NMSC) ensures access to superficial radiation therapy (SRT) as a treatment option for non-melanoma skin cancers in non-surgical patients. The policy does not cover image guidance with ultrasound for SRT as there is insufficient evidence to demonstrate HRUS guidance improves outcomes of SRT treatment.

Comments were received in opposition to the proposed coverage policy on Superficial Radiation Therapy (SRT) for Nonmelanoma Skin Cancers (NMSC). These comments were submitted by providers and expressed support for their current use of High-Resolution Ultrasound (HRUS) in Image-Guided Superficial Radiation Therapy (IGSRT). The letters emphasized that IGSRT is a safe and effective treatment and advocated for its continued coverage under Medicare in dermatology practices.

See response #2, 3. The LCD does not prohibit dermatologists from performing SRT; it expects that any provider utilizing these services has the experience and training necessary to deliver SRT in a safe manner and complies with all current guidelines for radiation therapy. Training and expertise must have been acquired within the framework of an accredited residency and/or fellowship program in the applicable specialty/subspecialty (i.e., Radiation Oncology OR by a qualified dermatology program of training with didactic and clinical experience in radiation treatment).

The LCD does not preclude the use of superficial radiation therapy (SRT); rather, it ensures that SRT remains accessible to appropriate patients. However, current evidence suggests that image guidance with each treatment has not been shown to clinically alter the effectiveness of SRT. In accordance with statutory requirements, any treatment or therapy that exceeds the patient’s needs is specifically excluded from coverage.

We received multiple Public Comments Opposing Proposed LCD on SRT for NMSC directed at Novitas Solutions, Inc. The emails came from a DART Advocacy email and consisted of provider letters in opposition to the proposed SRT LCD. These emails have few variations in their content with different provider signatures. The emails consisted of comments for Clinical Advocacy for Per-Treatment Ultrasound Imaging in Image Guided Superficial Radiation Therapy (IGSRT) for Non-Melanoma Skin Cancers. Expressing strong support for the continued coverage and per-treatment reimbursement of ultrasound image guided SRT for the treatment of nonmelanoma skin cancers (NMSCs) within dermatological practice and urging Novitas Solutions, Inc. to support the reimbursement of ultrasound imaging on a per-treatment basis as a critical component of IGSRT for NMSC.

We forwarded the comments to Novitas Solutions. Currently Novitas does not have a proposed LCD addressing SRT for the treatment of NMSC. See comments #2, #3, and #4.

We received multiple emails from a DART Advocacy email in opposition to the proposed SRT LCD directed at First Coast Service Options, Inc. (FCSO). These emails have few variations in their content with different beneficiary signatures. The emails consisted of beneficiary Public Comments Opposing Proposed LCD on SRT for NMSC. The letters expressed support for their current treatment of IG SRT.

We forwarded the comments to First Coast Service Options, Inc. (FCSO). Currently FCSO does not have a proposed LCD addressing SRT for the treatment of NMSC. See comments #2, #3, and #4.

Comments were received in opposition to the proposed coverage policy on Superficial Radiation Therapy (SRT) for Nonmelanoma Skin Cancers (NMSC). These comments were submitted via VoterVoice.net and expressed support for continued coverage of Image-Guided Superficial Radiation Therapy (IGSRT). The letters emphasized that IGSRT is a non-invasive treatment with high cure rates and urged preservation of access to this option for elderly and high-risk patients. The comments were from letters with minimal variation other than signature.

They included the cloned statement:
“I join more than 250,000 concerned Americans in strongly urging you to protect access to IGSRT and all medically appropriate treatment options. The proposed LCD eliminates Image Guidance — and in doing so, effectively eliminates access to IGSRT altogether. As a key decision-maker, your actions directly affect cancer patients’ ability to receive the care they need.”

The proposed local coverage determination Superficial Radiation Therapy (SRT) for the Treatment of Nonmelanoma Skin Cancers (NMSC) ensures access to superficial radiation therapy (SRT) as a treatment option for non-melanoma skin cancers in non-surgical patients. The policy does not cover image guidance with ultrasound for SRT as there is insufficient evidence to demonstrate HRUS guidance improves outcomes of SRT treatment. There are no direct head-to-head trials between HRUS IGSRT and SRT. Upon review of the SRT literature the quality of evidence is low to support the use of HRUS with SRT. The studies reporting 99% cure rate are at high risk of bias and provide indirect comparisons with standard care for NMSC, such as MMS. Prospective comparison studies that directly compare IG-SRT and surgery in well-matched patient groups are needed to enable conclusions on comparative outcomes. In addition, there are no validated protocols for assessing tumor depth by ultrasound nor correlation of ultrasound tumor depth with microscopic tumor invasion, there is no evidence to support that the addition of HRUS to SRT is required for the treatment of low-risk BCC or low-risk SCC. HRUS IG-SRT’s comparative safety and effectiveness cannot be determined because available comparison studies are at high risk of bias.

Comments were received from an industry stakeholder opposing the elimination of coverage for Electronic Brachytherapy (EBT) for nonmelanoma skin cancers. These comments emphasized that EBT is a safe and effective non-surgical treatment with cure rates over 98%, supported by extensive clinical evidence. Concerns were raised that eliminating coverage could restrict access, particularly for patients in rural or underserved areas. Commenters urged consideration of the clinical evidence and continuation of coverage to ensure patient access to this therapy.

Thank you for your comment. Even though a growing set of literature exists regarding the use of EBT for NMSC, follow-up remains short. Based upon the consensus of the literature and the recommendations of the AAD, ASTRO and ABS, the use of EBT for the treatment of NMSCs is not considered reasonable and necessary at this time due to low confidence in published evidence, lack of long-term outcome data, uncertain patient selection criteria, lack of standardized applications and uncertainty regarding long-term risk associated with the treatment and insufficient long-term efficacy and safety data to support the use of electronic surface brachytherapy as reasonable and necessary.

Comments were received opposing the proposed changes to coverage for per-treatment ultrasound imaging in Image-Guided Superficial Radiation Therapy (IGSRT) for nonmelanoma skin cancers. These comments emphasized the clinical necessity of ultrasound imaging, which enhances treatment precision by adapting to real-time changes in tumor characteristics. They cited studies demonstrating high cure rates with IGSRT and highlighted the importance of ultrasound for accurate dosing and protecting healthy tissue. Professional standards set by ARRT and ASRT were referenced to support the use of imaging in treatment. The commenters urged continued reimbursement for per-treatment ultrasound to ensure safe, adaptive care, especially for vulnerable patient populations.

Thank you for the comments. Upon review of the literature, the quality of evidence is low to support the use of high-resolution ultrasound (HRUS) with superficial radiation therapy (SRT). There are no validated protocols for assessing tumor depth by ultrasound nor correlation of ultrasound tumor depth with microscopic tumor invasion. There is no evidence to support the addition of HRUS to SRT as improving outcome or safety to the treatment of low-risk basal cell carcinoma (BCC) or low-risk squamous cell carcinoma (SCC). The comparative safety and effectiveness of HRUS-guided IGSRT cannot be determined because available comparison studies are at high risk of bias and provide indirect comparisons with standard care for nonmelanoma skin cancers. Prospective studies directly comparing HRUS-guided IGSRT and surgery in well-matched patient groups are needed to enable conclusions comparing outcomes.

Comments were received arguing that incorporating high-frequency ultrasound (HFUS) into superficial radiation therapy (SRT) systems enhances treatment planning and monitoring, especially given the variable depths of nonmelanoma skin cancer (NMSC) lesions. These commenters expressed concern that removing HFUS could result in less precise treatments and increased costs by shifting patients to more invasive and expensive alternatives such as Mohs surgery or electron beam therapies. They criticized the proposed policy for failing to address the root causes of billing overutilization and for relying on flawed studies to justify restrictions on HFUS. Commenters advocated for continued use of HFUS, citing its importance in ensuring effective, safe, and cost-efficient patient care. They urged rejection of the current policy and offered to collaborate on developing a more beneficial alternative for Medicare beneficiaries.

Thank you for your comments. See response to comment #2, 3, 4. The proposed local coverage determination Superficial Radiation Therapy (SRT) for the Treatment of Nonmelanoma Skin Cancers (NMSC) ensures access to superficial radiation therapy (SRT) as a treatment option for non-melanoma skin cancers in non-surgical patients. The policy does not cover image guidance with ultrasound for SRT as there is insufficient evidence to demonstrate HRUS guidance improves outcomes of SRT treatment.

Comments were received in support of the proposed policy. These commenters asserted that the scientific evidence supporting Image-Guided Superficial Radiation Therapy (IGSRT) is insufficient and expressed concern that industry support for IGSRT may be financially motivated rather than grounded in rigorous clinical research. They commended the policy for prioritizing high-quality evidence and aligning with standards for patient care and responsible use of public healthcare resources.

Thank you for your support of the LCD and evidence-based decision making. We appreciate your careful review of the LCD and thoughtful feedback.

We received comments highlighting dermatologists' longstanding role in treating NMSC and argue for clinical decision-making autonomy, stressing that dermatologists should be included among qualified providers of SRT without restrictive training requirements. They also express concern that proposed qualifications could limit access to SRT and create barriers to timely treatment.

Thank you for your comments. The LCD does not prohibit dermatologists from performing SRT, it expects that any provider utilizing these services has the experience and training necessary to deliver SRT in a safe manner and complies with all current guidelines for radiation therapy. Training and expertise must have been acquired within the framework of an accredited residency and/or fellowship program in the applicable specialty/subspecialty (i.e., Radiation Oncology OR by a qualified dermatology program of training with didactic and clinical experience in radiation treatment). See response #2, 3, 4.

Comments were received requesting updates to the background and history section of the proposed policy to clarify that very high-risk squamous cell carcinoma (SCC) can be treated with surgery or Mohs micrographic surgery, consistent with NCCN guidelines. Commenters recommended adding language to the coverage indications specifying that a radiation oncologist should determine the appropriateness of superficial radiation therapy (SRT). They also noted that standard excision is the primary recommended treatment for low-risk basal cell carcinoma (BCC) and SCC. Additionally, they suggested removing generalized statements from the principles of treatment section that reflect goals rather than specific recommendations and urged that the coverage mechanism align more closely with NCCN guidelines.

Thank you for the comments and suggestions for language clarification. The intent of the policy is not to educate about recommended treatments for SCC or BCC, but to establish coverage criteria consistent with current evidence for the treatment of nonmelanoma skin cancers (NMSCs) using superficial radiation therapy (SRT). The policy addresses variations of SRT that include high-resolution ultrasound (HRUS) guidance and electronic brachytherapy (EBT). The feedback regarding NCCN guideline alignment and clarifying language has been noted and will be considered in the finalization of the policy.

Comments were received from a practicing dermatologist who provides radiation therapy in-office. The commenter stated the therapy has helped patients avoid the morbidity associated with Mohs surgery and large tumors in cosmetically sensitive areas. They supported the use of ultrasound guidance for radiation therapy delivery and requested that dermatologists not be excluded from overseeing radiation services. The comments also emphasized the medical necessity of electronic brachytherapy, requested further clarity on the definition of non-surgical candidates, and advocated for the removal of size restrictions for basal cell carcinomas (BCCs).

Thank you for your comments. The proposed local coverage determination Superficial Radiation Therapy (SRT) for the Treatment of Nonmelanoma Skin Cancers (NMSC) ensures access to superficial radiation therapy (SRT) as a treatment option for non-melanoma skin cancers in non-surgical patients. The policy does not cover image guidance with ultrasound for SRT as there is insufficient evidence to demonstrate HRUS guidance improves outcomes of SRT treatment. See response to comment #2, 3, 4.

Comments were received expressing concern about the lack of supporting evidence for image-guided superficial radiation therapy (IGSRT) and the potential for increased treatment costs associated with its use. The commenters emphasized that while superficial radiation therapy (SRT) has a role in treating nonmelanoma skin cancers, the addition of image guidance does not appear to improve clinical outcomes, side effects, or patient experience, and may contribute to unnecessary healthcare expenditures.

Thank you for your support of the proposed policy and commitment to evidence-based decision making. We appreciate your careful review and thoughtful feedback.

Comments were received from providers with extensive experience in outpatient radiation therapy, including ultrasound-guided superficial radiation therapy (IGSRT) and electronic brachytherapy (EBT). These commenters argued that there is sufficient literature to support both modalities as reasonable and necessary, and that they are safe and effective first-line treatments for appropriately selected cases of nonmelanoma skin cancer (NMSC). They emphasized the benefits of ultrasound guidance, citing its use as standard practice and referencing stakeholder meetings. They urged coverage for image-guided SRT and EBT, noting that larger lesions can be treated and that EBT is analogous to SRT. They supported allowing board-certified radiation oncologists or appropriately trained dermatologists to deliver these therapies. Concerns were raised that the policy may lead to increased surgical management, hospital-based radiation treatment, suboptimal office treatments, increased health care disparities, access issues, and undermining of multidisciplinary care.

Thank you for your comments. See response to comments #2-4, 7-10, 14.

Comments were received expressing concern that the use of image-guided superficial radiation therapy (IGSRT) represents an egregious misuse. While superficial radiation therapy (SRT) has a recognized role in the treatment of nonmelanoma skin cancer (NMSC), these commenters stated that the addition of image guidance does not improve outcomes, side effects, or patient experience, and increases cost. They requested continued reimbursement for SRT but urged restriction or elimination of reimbursement for image guidance, which they viewed as superfluous.

Thank you for your support of the LCD and evidence-based decision making. We appreciate your careful review of the LCD and thoughtful feedback.

Comments were received stating that the evidence for ultrasound guidance with superficial radiation therapy (SRT) is extremely weak and that this treatment modality is likely being significantly overused and abused. These commenters emphasized the importance of evidence-based medicine and supported the policy’s conclusion that image guidance is not reasonable or necessary.

Thank you for your support of the LCD and evidence-based decision making. We appreciate your careful review of the LCD and thoughtful feedback.

Comments were received opposing the exclusion of electronic brachytherapy (EBT) from coverage. Providers reported years of real-world experience and described EBT as FDA-cleared, non-invasive, and safe for elderly and high-risk populations. They emphasized excellent cosmetic outcomes, minimal downtime, and local control rates comparable to Mohs surgery. Cited studies included Doggett 2023 (7.6-year follow-up, 98.9% local control), Patel 2017 (matched-pair vs Mohs, non-inferior outcomes), and Cheng 2024 (Esteya post-market study, <1% recurrence, 87% good cosmesis). Commenters warned that removing coverage would force patients into more invasive procedures, increase complications and costs, and undermine physician-patient decision making.

Thank you for your comments. See response to comment #8.

Comments were received from industry stakeholders and providers opposing the exclusion of electronic brachytherapy (EBT) from coverage. These commenters cited publications including Doggett 2023, Patel 2017, and Cheng 2024, reporting >98% local control, non-inferior outcomes to Mohs surgery, and favorable cosmetic results. They highlighted technical advantages of EBT such as hypofractionation (8–10 treatments vs. 25–30 with electrons), favorable dosimetry, safety (staff presence during treatment), and cost-efficiency. Commenters also referenced CPT Editorial Panel decisions aligning HDR-EBT with SRT codes effective in 2026. Additionally, commenters defended the integration of high-resolution ultrasound (HRUS) with SRT systems, citing its role in supporting the ALARA principle, accurate dosing, and treatment monitoring. A compromise was proposed to limit G6001 billing. Commenters emphasized that EBT serves vulnerable elderly patients and should not be excluded from coverage.

Thank you for your comments. See response to comment #2-4, 7-10.

Radiation oncologists with experience in EBT urge reversal of non-coverage, citing long-term series (Doggett 2023, Patel 2017, Paravati 2015) showing ≥98% LC and cosmesis comparable to Mohs, arguing LCD misrepresents ABS consensus, omits key studies, and utilized narrow search terms. Highlighted advantages were shorter regimen (8–10 tx), homogeneous dosing on irregular contours, safety, lower cost (75–100% less than electron beam), and better tolerability in elderly. Stressed points were NCCN listing EBT as RT variant and CPT alignment reflecting clinical equivalence. LCD revision was requested with recognition of EBT as reasonable and necessary.

Thank you for your comments. See response to comment #8.

Comments were received from patients opposing the exclusion of image-guided superficial radiation therapy (IGSRT) with high-resolution ultrasound (HRUS). These commenters described IGSRT as a safe, painless, non-surgical alternative with excellent cosmetic results, particularly important for facial lesions and elderly or high-risk patients. Most emphasized firsthand experiences of successful treatment or referenced their community’s use of IGSRT. Some cited supportive evidence second-hand from providers (Yu 2021; McClure 2023/24; Farberg 2024; Ma 2024; Stricker 2024; Moloney 2025), claiming cure rates above 99% and equivalence or superiority to surgery. The core argument was that denying coverage would deprive Medicare patients of access to an FDA-cleared, non-invasive option.

Thank you for your comments. See response to comments #8–10. The proposed Local Coverage Determination Superficial Radiation Therapy (SRT) for the Treatment of Nonmelanoma Skin Cancers (NMSC) ensures access to superficial radiation therapy (SRT) as a treatment option for non-melanoma skin cancers in non-surgical patients. The policy does not cover image guidance with ultrasound for SRT as there is insufficient evidence to demonstrate HRUS guidance improves outcomes of SRT treatment. There are no direct head-to-head trials between HRUS IGSRT and SRT. Upon review of the SRT literature the quality of evidence is low to support the use of HRUS with SRT. The studies reporting 99% cure rate are at high risk of bias and provide indirect comparisons with standard care for NMSC, such as MMS. Prospective comparison studies that directly compare IG-SRT and surgery in well-matched patient groups are needed to enable conclusions on comparative outcomes. In addition, there are no validated protocols for assessing tumor depth by ultrasound nor correlation of ultrasound tumor depth with microscopic tumor invasion, there is no evidence to support that the addition of HRUS to SRT is required for the treatment of low-risk BCC or low-risk SCC. HRUS IG-SRT’s comparative safety and effectiveness cannot be determined because available comparison studies are at elevated risk of bias.

Comments were received opposing the exclusion of image-guided superficial radiation therapy (IGSRT). These comments cited studies such as Yu 2021–23, McClure 2023/24, Farberg 2024, Ma 2024, Stricker 2024, and Moloney 2025, reporting high local control rates and asserting that IGSRT is non-inferior or superior to Mohs surgery. Commenters emphasized the importance of daily ultrasound for adaptive dosing, noting that 29–40% of lesions require adjustment. They argued that the policy conflates outdated SRT with modern IGSRT and that the expert panel lacked IGSRT-specific expertise. Additional references included ECRI’s favorable technology rating and DART guidelines for BCC/SCC. Commenters asserted that IGSRT outcomes equal or surpass Mohs in both control and cosmetic results.

Thank you for your comments. See response to comments #2-4, 7-10, 14, and 22.

A smaller set of commenters opposed the exclusion of IGSRT without clear identification as patient or provider. Submissions echoed themes of safety, cosmesis, and access for elderly patients, and sometimes referenced the same Yu/McClure/Farberg studies.

Thank you for your comments. See responses to comments #2-4, 8-10, and 22.

Comments were received supporting the conclusion that high-resolution ultrasound (HRUS) is not reasonable and necessary with superficial radiation therapy (SRT). These commenters emphasized that no high-quality evidence demonstrates HRUS improves local control, cosmetic outcomes, or toxicity. They noted that daily ultrasound adds cost and complexity without clinical benefit. Commenters stated that image-guided radiation therapy (IGRT) is appropriate for deep tumors but not for SRT in skin cancer. Others stressed that studies cited by proponents of HRUS-guided SRT are methodologically flawed and do not justify routine use. Additional comments commended the policy for preserving access to SRT for nonsurgical patients without mandating HRUS.

Thank you for your support of the policy and evidence-based decision making. We appreciate your careful review and thoughtful feedback.

Comments were received supporting the policy’s exclusions of high-resolution ultrasound (HRUS), image-guided superficial radiation therapy (IGSRT), and electronic brachytherapy (EBT). These commenters endorsed limiting superficial radiation therapy (SRT) to nonsurgical candidates with appropriate documentation. They cited concerns about the lack of high-quality evidence, methodological flaws in supporting studies, industry influence, and publication bias. One study published in JAAD was referenced as showing that ultrasound adds cost without clinical benefit. Commenters also questioned the credibility of reported IGSRT cure rates above 99%, attributing differences to higher dosing and fractionation rather than ultrasound guidance. They supported restricting complex simulation and planning codes and affirmed that most patients with nonmelanoma skin cancer (NMSC) remain appropriate candidates for surgery.

Thank you for your support of the policy and evidence-based decision making. We appreciate your careful review and thoughtful feedback.

Comments were received supporting the billing and coding article associated with the policy. These commenters endorsed restricting the use of codes 77280–77290, 77262–77263, 77333–77336, 77600, 0394T, and G6001 with superficial radiation therapy (SRT), noting that these codes reflect complex planning not required for superficial therapy and were being misused. They also supported the requirement that SRT be performed by physicians with appropriate training, such as completion of a residency or fellowship in radiation oncology or dermatology with documented radiation training. Commenters emphasized that such qualifications are essential to ensure safety and quality of care.

Thank you for your support of the policy and the coding restrictions in the associated billing and coding article.

Comments were received recommending that coverage policies incorporate NCCN Guidelines to ensure alignment with current clinical standards. These comments requested clarification that both surgery and Mohs are valid options for very high-risk squamous cell carcinoma (SCC), and that excision is the standard treatment for low-risk basal cell carcinoma (BCC) and SCC. They suggested removing generalized treatment statements in favor of NCCN-specific recommendations. Commenters expressed concern about the routine use of superficial radiation therapy (SRT) and electronic brachytherapy (EBT) in non-specialist settings lacking appropriate dosimetry and safety oversight. They affirmed that EBT should only be performed by radiation oncologists with physics support, ideally in trial or registry settings.

Thank you for your comments. Contractors must follow the LCD development process outlined on the CMS internet-only manual (IOM), Publication 100-08, Medicare Program Integrity Manual (PIM), Chapter 13, Section 13.2. Contractors cannot defer coverage to future updates of guidelines. The authority of a Medicare Administrative Contractor (MAC) is to provide reasonable and necessary coverage under Section 1862 (a) (1) (A) of the Social Security Act. MACs do not possess the authority to provide coverage with evidence development (CED). The authority to provide CED is with CMS under Section 1862 (a) (1) (E) which addresses research conducted pursuant to section 1142.

Comments were received supporting the policy and the associated billing and coding article. These commenters expressed concern about the overutilization of image-guided superficial radiation therapy (IGSRT) in community settings, describing it as financially motivated rather than evidence-based. They criticized studies supporting IGSRT as being published in pay-to-publish journals with biased sponsorship, poor design, and lack of long-term follow-up. Commenters emphasized the importance of aligning Medicare coverage with rigorous peer-reviewed evidence to preserve public trust and commended the policy for maintaining high evidence standards.

Thank you for your support of the policy and the associated billing and coding article. We appreciate your thoughtful feedback and careful review of the available literature.

Comments were received from a board-certified dermatologist who served as a subject matter expert in the development of the policy. The commenter expressed support for superficial radiation therapy (SRT) as a second-line treatment and voiced concern about the expansion of image guidance, citing low-quality literature. The comment emphasized that the policy is necessary to preserve patient access and prevent aggressive or abusive billing practices. The commenter agreed with the proposed provider qualifications and submitted detailed coding recommendations, including prohibiting the use of simulation codes (77280–77290), CPT 77336, G6001, 77262–77263, 77333–77334, and 77600 with SRT. They recommended limiting planning codes to 77261 and allowing only simple device code 77332 in rare cases.

Thank you for your support of the policy and for your coding recommendations.

Comments(s) were received expressing strong support for the policy and its associated billing and coding guidance. These commenters endorsed the criteria for when superficial radiation therapy (SRT) is reasonable and necessary, citing alignment with guidelines from the American Academy of Dermatology (AAD), American Society for Radiation Oncology (ASTRO), and National Comprehensive Cancer Network (NCCN). They agreed that high-resolution ultrasound (HRUS) is not supported by high-quality evidence and that tumor size does not change meaningfully between treatment fractions. They supported the policy’s criteria for when SRT is not appropriate, the proposed provider qualifications, and requirements for radiation protection, quality assurance, and supervision. Commenters commended the policy’s methodical and guideline-based approach to evidence review, including the exclusion of case reports, abstracts, and industry-sponsored studies in favor of randomized trials and long-term data. They supported non-coverage of electronic brachytherapy (EBT) and image-guided SRT (IGSRT) due to lack of long-term efficacy data and concerns about publication bias. They also submitted coding recommendations, including:

• Prohibiting CPT code 77290 with SRT
• Prohibiting CPT codes 77262, 77333, 77334, and 77427 with SRT
• Encouraging voluntary use of Advance Beneficiary Notices (ABNs) in both GY and GZ scenarios.

Thank you for your support of the policy and evidence-based decision making. We appreciate your coding recommendations and thoughtful feedback.

Comments were received supporting the proposed coverage policy for superficial radiation therapy (SRT). These commenters agreed that high-resolution ultrasound (HRUS) is not medically necessary and lacks supporting evidence for improved outcomes. They stated that the policy preserves access to SRT for appropriate patients while limiting the costly and unproven addition of HRUS.

Thank you for your support of the policy and evidence-based decision making. We appreciate your careful review and thoughtful feedback.

Comments were received expressing support for the proposed coverage policy. These commenters commended the policy for providing clarity on the use of image-guided radiation therapy and strongly agreed with the position that high-resolution ultrasound (HRUS) is not necessary for the delivery of superficial radiation therapy (SRT). They stated that the policy sets a precedent by not recommending technologies that lack support from medical literature and expert consensus, while preserving access to SRT for beneficiaries.

Thank you for your support of the policy and evidence-based decision making. We appreciate your review and thoughtful feedback.

Comments were received urging reconsideration of the non-coverage of electronic brachytherapy (EBT) for the treatment of nonmelanoma skin cancers (NMSC). These commenters stated that EBT achieves high cure rates with excellent safety and cosmetic outcomes, comparable to other definitive therapies. They cited studies such as Kuo 2023, Barker 2024, Cheng 2024, and Doggett 2023, reporting favorable long-term outcomes. They noted that while earlier guidelines limited EBT to trials or registries, newer evidence supports broader use. Commenters also clarified that they do not support the use of high-resolution ultrasound (HRUS) with superficial radiation therapy (SRT), citing insufficient evidence.

Thank you for your comments. See response to comments #8. The literature references submitted with this comment were of low quality and did not change the recommendations or consensus of the literature.

Comments were received expressing strong support for the proposed coverage policy, particularly the provision that deems high-resolution ultrasound (HRUS) to guide superficial radiation therapy (SRT) delivery as not reasonable or medically necessary and not supported by literature. These commenters stated that all studies cited in support of HRUS have significant flaws and limitations. They also suggested minor changes to the policy language, including replacing the term “second line” with “alternative” and removing the phrase “when after documentation of shared decision making” from the covered indications section to reduce the risk of misinterpretation and unnecessary denials.

Thank you for your support of the policy. We appreciate your review and thoughtful feedback. Currently, no changes to the language are planned.

Comments were received opposing the exclusion of high-resolution ultrasound (HRUS) with superficial radiation therapy (SRT). These commenters stated that HRUS is essential and that providers would be “treating blindly” without it. They emphasized the importance of visualizing lesion depth and shape throughout treatment to reduce the risk of geographic miss- and under-treatment. They argued that clinical utility should not be judged solely on the presence or absence of randomized trials and stated that, in their experience, HRUS makes treatment safer, more effective, and better tailored to individual patients.

Thank you for your comments. See response to comments #2, 9, 10, and 14.

Comments were received supporting the use of high-resolution ultrasound (HRUS) at key points in the treatment process. These commenters stated that baseline HRUS is necessary to determine lesion depth and breadth to assess whether superficial radiation therapy (SRT) is appropriate. They also recommended ultrasound imaging after treatment and again at six weeks to evaluate treatment response. While agreeing that daily ultrasound is unnecessary, they suggested reimbursement for a minimum of three ultrasound scans per treatment course.

Thank you for your comments. See response to comments # 2, 9, 10, and 14.

Comments were received opposing the limitation of high-resolution ultrasound (HRUS) during superficial radiation therapy (SRT). These commenters stated that ultrasound is essential for localizing the treatment field and adjusting prescription depth. They suggested a more balanced approach that would allow ultrasound guidance weekly or every five sessions to maintain clinical benefits while reducing overutilization.

Thank you for your comments. See response to comments #2, 9, 10, and 14.

Comments were received opposing the exclusion of coverage for electronic brachytherapy (EBT) for nonmelanoma skin cancers. These commenters cited studies such as Doggett 2023, Patel 2017, and Paravati 2015, which report long-term follow-up and favorable outcomes. They argued that the 2015 American Brachytherapy Society (ABS) consensus statement was misinterpreted and did not prohibit EBT use. They referenced CPT Editorial Panel decisions from 2024 and 2025, affirming that EBT and SRT will be reported under CPT code 77X07. Commenters noted that NCCN, AAD, ASTRO, AAPM, ABS, and ACR recognize EBT as a valid modality. They expressed concern that eliminating EBT would reduce access for elderly or frail patients, mislead providers and patients, and diminish patient autonomy. They requested that EBT be treated under the same reasonable and necessary framework as SRT.

Thank you for your comments. See response to comments #8 and 19–21.

Comments were received opposing the exclusion of image guidance with superficial radiation therapy (SRT). These commenters stated that image guidance is a major advancement that allows visualization of tumor size, depth, and morphology before each treatment session, enabling precise targeting and adaptive dosing. They cited studies reporting control rates above 99% and argued that outcomes are comparable to or better than Mohs surgery. Commenters criticized the reliance on outdated guidelines and noted that the cited ASTRO guideline does not address IGSRT. They emphasized that randomized trials are impractical and unethical, and referenced favorable decisions from Medicare Administrative Law Judges (ALJs) and C2C Innovative Solutions supporting IGSRT. They argued that the LCD imposes stricter provider qualifications than CMS policy and disproportionately impacts older adults, rural residents, and those with limited mobility.

Thank you for your comments. See response to comments #2, 9, 10, and 14.

Comments were received opposing the exclusion of coverage for electronic brachytherapy (EBT) for nonmelanoma skin cancers. These commenters cited studies such as Doggett 2023, Patel 2017, and Paravati 2015, which report long-term follow-up and favorable outcomes. They argued that a guideline cited in the policy was flawed due to author conflicts and exclusion of relevant EBT literature. They referenced CPT Editorial Panel decisions affirming that EBT and SRT will be reported under CPT code 77X07. Commenters noted that NCCN, AAD, ASTRO, AAPM, ABS, and ACR recognize EBT as a valid modality. They expressed concern that eliminating EBT would reduce access for elderly or frail patients, mislead providers and patients, and diminish patient autonomy. They requested that EBT be treated under the same reasonable and necessary framework as SRT.

Thank you for your comments. See response to comments #8 and 19–21.

Comments were received expressing non-support for the proposed Local Coverage Determination (LCD) on superficial radiation therapy (SRT). These comments stated that the LCD relies on outdated studies and omits recent peer-reviewed research from 2023–2025, including studies demonstrating high control rates (>99%) for image-guided superficial radiation therapy (IGSRT). Concerns were raised that the LCD does not reference the ECRI dataset or recent guidelines from clinical organizations.
Commenters argued that randomized controlled trials are not required by Medicare and may be impractical or unethical in this context. They also questioned the relevance of the ASTRO guideline cited in the LCD, noting it does not address IGSRT or high-resolution ultrasound (HRUS). Commenters asserted that IGSRT is equal to or superior to Mohs surgery in treating early-stage nonmelanoma skin cancers (NMSCs), with HRUS improving control and cure rates.

Thank you for your comments. See response to comments #2, 9, 10, and 14.

Commenters expressed strong opposition to the proposed coverage policy, stating that it is outdated and conflates superficial radiation therapy (SRT) with image-guided superficial radiation therapy (IGSRT). They emphasized that improvements in outcomes with high-resolution ultrasound (HRUS) have been extensively demonstrated in multiple studies, and that cure rates with IGSRT are equivalent to or greater than those achieved with Mohs surgery. The comment also argued that randomized controlled trials are not practical or ethical for this treatment modality. Concern was raised that the policy references only a single study, specifically the Likhacheva guideline, which they believe does not pertain to IGSRT and should not be used to inform coverage decisions. The commenters stated that the literature supports IGSRT as a primary treatment for both low- and high-risk basal cell carcinoma (BCC) and squamous cell carcinoma (SCC). They disagreed with the tumor size and depth limitations outlined in the policy, noting that tumors larger than 4 cm may be treatable if uniformly thin. Additionally, they expressed concern that the policy suggests SRT should be delivered under the supervision of a radiation oncologist, which deviates from current practice where dermatologists safely and effectively provide SRT. They warned that limiting IGSRT and restricting delivery to radiation oncologists would reduce access to care, particularly in rural areas, and could result in patients facing long travel distances, less effective treatment options, or foregoing care entirely.

Thank you for your comments. See response to comments #2, 9, 10, and 14.