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

We received a comment that opposes eliminating coverage for Electronic Brachytherapy (EBT) for nonmelanoma skin cancers. They argue that EBT is a safe and effective non-surgical treatment with cure rates over 98%, supported by extensive clinical evidence. Eliminating coverage could restrict access, especially for patients in rural or underserved areas. Elekta urges the policy unit to consider the clinical evidence and continue covering EBT, ensuring patient access to this important 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 American Academy of Dermatology (AAD), the American Society for Therapeutic Radiology and Oncology (ASTRO) and the American Brachytherapy Society (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, 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.

We received comments that oppose the proposed changes to coverage for per-treatment ultrasound imaging in Image-Guided Superficial Radiation Therapy (IG-SRT) for non-melanoma skin cancers. Commenters emphasize the clinical necessity of this imaging, which enhances treatment precision by adapting to real-time changes in tumor characteristics. Studies demonstrating high cure rates with IGSRT and the importance of ultrasound for accurate dosing and protecting healthy tissue are cited. Commenters also reference professional standards set by the American Registry of Radiologic Technologists (ARRT) and the American Society of Radiologic Technologists (ASRT) supporting the use of imaging in treatment. They urge continued reimbursement for per-treatment ultrasound to ensure safe, adaptive care, especially for vulnerable patient populations.

Thank you for your comments. Upon review of the SRT literature, the quality of evidence is low to support the use of High-Resolution Ultrasound (HRUS) with SRT. There are no validated protocols for assessing tumor depth by ultrasound nor correlation of ultrasound tumor depth with microscopic tumor invasion andthere 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 and provide indirect comparisons with standard care for NMSC, such as Mohs micrographic surgery (MMS). Prospective comparison studies that directly compare HRUS IG-SRT and surgery in well-matched patient groups are needed to enable conclusions on comparative outcomes.

Comments were received arguing that incorporating high-frequency ultrasound (HFUS) into their SRT systems enhances treatment planning and monitoring, which is crucial given the variable depths of NMSC lesions. Removing HFUS from the procedure could lead to less precise treatments and increased costs by shifting patients to more invasive and expensive alternatives like Mohs surgery or electron beam therapies. They critique the LCD for not addressing the root cause of billing overutilization and for relying on flawed studies to restrict HFUS. Commenters advocate for continued HFUS use, highlighting its importance in ensuring effective, safe, and cost-efficient patient care. They urge rejection of the current LCD and offer to help develop a more beneficial alternative for Medicare beneficiaries.

Thank you for your comments. See response to comment #2. The proposed LCD, Superficial Radiation Therapy (SRT) for the Treatment of Nonmelanoma Skin Cancers (NMSC) ensures access to SRT as a treatment option for NMSC 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.

We received comments in support of the LCD. They assert that the scientific backing for Image-Guided Superficial Radiation Therapy (IGSRT) is insufficient and suggest that industry support for IGSRT is financially motivated rather than evidence-based. Dermatologists support the draft LCD as it prioritizes high-quality evidence and aligns with Medicare standards for patient care and efficient use of public funds. They appreciate the opportunity to provide feedback on the policy.

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 #3.

We received a comment that requests for changes within the background and history section to update " Very high-risk SCC can be treated with ….... Per NCCN guidelines.", the addition of clarifying language within coverage indications that radiation oncologist should determine appropriateness of SRT, noting that standard excision is also a primary recommended treatment for low -risk SCC and BCC, removing references from principles of treatment that are general goals rather than recommendations and making the coverage mechanism adhere to NCCN guidelines.

Thank you for your comments. See response to comment #5. We appreciate your review of the LCD and your suggestions for language clarification. We recognize that standard excision is also a primary recommended treatment for low-risk SCC and BCC; but the intent of this LCD is not to educate about recommended treatments for SCC or BCC. The LCD is intended to create a policy consistent with current evidence for the treatment of nonmelanoma skin cancers (NMSCs) with superficial radiation therapy (SRT) and addresses a variation of SRT utilizing High-Resolution Ultrasound (HRUS) guidance, and electronic brachytherapy (EBT), for the treatment of nonmelanoma skin cancers (NMSCs).

We received comments from practicing dermatologists who provide radiation therapy in their offices. They state the use of the therapy has saved many patients from the morbidity of Mohs surgery or large tumors in cosmetically sensitive areas. They support ultrasound guidance for delivery of radiation therapy, request to ensure dermatologists are not excluded from overseeing radiation services and concludes medical necessity of electronic brachytherapy. They request further clarity on who is a non-surgical candidate and removal of size restrictions for BCCs. No supporting literature was included.

Thank you for your comments. See response to comment #2. The proposed LCD, Superficial Radiation Therapy (SRT) for the Treatment of Nonmelanoma Skin Cancers (NMSC) ensures access to SRT as a treatment option for NMSC 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.

A comment from a Mohs surgeon expresses concern over lack of supporting evidence for image-guided superficial radiation therapy and increasing costs related to treatment.

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

A comment was received from a radiation oncologist with extensive experience in the use of ultra-sound guided SRT and electronic brachytherapy in the outpatient setting. He argues there is sufficient literature to support its use as reasonable and necessary, and the service is a safe and effective first line treatment for appropriately selected cases of NMSC. He states the benefit of ultrasound guidance and refers to the CAC meeting stating this is standard practice in the field. He urges coverage for image guided SRT. He also endorses coverage for EBT stating it is a safe and effective treatment. He states larger lesions can be treated and the technology is analogous to SRT. He supports that a board-certified radiation oncologist or appropriately trained dermatologist has the experience and training necessary to deliver SRT in a safe manner and complies with all current guidelines for radiation therapy. He states the policy may lead to increases in surgical management, in-hospital radiation treatments, suboptimal office treatments, increase in health care disparities, access to care issues and undermines multidisciplinary care.

Thank you for your comments. See response to comment #1-4 and 7.

Commenters stated the use of image guided SRT stands out as an egregious misuse. While SRT has always had a place in the treatment of skin cancer, it is well proven that the addition of image guidance with each treatment does nothing to enhance or improve outcomes. They state the addition of image guidance does not improve outcomes, side effects or patient experience, but substantially increases costs. They request continued reimbursement for SRT but restrict or eliminate the reimbursement for superfluous image guidance.

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

Dermatologists submitted comments stating they strongly believe in evidence-based medicine. The evidence for ultrasound guidance with SRT is extremely weak and this treatment modality is likely being significantly overused and abused.

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

Providers strongly oppose the LCD exclusion of EBT. They report 8–12 years of real-world practice experience with thousands of patients. Providers argue EBT is FDA-cleared, non-invasive, safe for elderly and high-risk patients, with excellent cosmesis and minimal downtime. They stress that 5-year local control rates rival Mohs surgery, with recurrence in the low single digits. Cited studies include: Doggett 2023 (7.6 yr FU, 98.9% LC), Patel 2017 (matched-pair vs Mohs, non-inferior outcomes), and Cheng 2024 (post-market Esteya study, <1% recurrence, 87% good cosmesis). They warn removal of 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 # 1.

We acknowledge extensive provider experience and supportive literature. However, NCCN, AAD, ASTRO, and ABS guidelines still conclude insufficient prospective, comparative, long-term data to support EBT as standard of care. The LCD continues to exclude EBT as not reasonable and necessary. Prospective registries or trials with long-term follow-up are required.

Industry commenters strongly oppose exclusion of EBT. Elekta requests removal of all EBT references, arguing 2019 consensus guidelines were flawed and excluded EBT experts. Provided publications included: Doggett 2023, Patel 2017, and Cheng 2024, showing >98% LC, non-inferior to Mohs, favorable cosmesis. The commenter highlights technical advantages: hypofractionation (8–10 tx vs 25–30 with electrons), favorable dosimetry, safety (staff in room), cost-efficiency, and CPT Editorial Panel alignment of HDR-EBT with SRT codes (effective 2026). Sensus defends HRUS integration with its SRT-100 Vision system, arguing ultrasound supports ALARA principle, accurate dosing, and monitoring, proposing compromise of limiting G6001 billing. Both stress EBT is being unfairly excluded and serves vulnerable elderly patients.

Thank you for your comments. See response to comment # 1.

We acknowledge manufacturer input and cited publications. However, contractor maintains guideline consensus (NCCN/AAD/ASTRO/ABS) finding evidence insufficient for broad EBT coverage. The LCD continues exclusion pending stronger prospective evidence. HRUS is not considered reasonable and necessary for SRT at this time.

Radiation oncologists with >10 years of experience in EBT urge reversal of non-coverage. They cite long-term series (Doggett 2023, Patel 2017, Paravati 2015) showing ≥98% LC and cosmesis comparable to Mohs. Commenters argue the LCD misrepresents ABS consensus, omits key studies, and used narrow search terms. They highlight advantages: shorter regimen (8–10 tx), homogeneous dosing on irregular contours, safety, lower cost (75–100% less than electron beam), and better tolerability in the elderly. They stress NCCN lists EBT as an RT variant and CPT alignment reflects clinical equivalence. They request an LCD revision and recognition of EBT as reasonable and necessary.

Thank you for your comments. See response to comment # 1.

Patients strongly oppose the LCD exclusion of IGSRT with high-resolution ultrasound. Most letters describe IGSRT as a safe, painless, non-surgical alternative with excellent cosmetic results, particularly important for facial lesions and elderly/high-risk patients. Many emphasize personal experiences of successful treatment or reference their community’s use of IGSRT. Some letters cite 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 is 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 #2-4. The proposed LCD, Superficial Radiation Therapy (SRT) for the Treatment of Nonmelanoma Skin Cancers (NMSC) ensures access to SRT as a treatment option for NMSC 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.

We acknowledge patient perspectives and personal experiences. However, coverage determinations must be based on rigorous evidence. Current NCCN, AAD, ASTRO, and ABS guidelines do not endorse IGSRT as standard of care due to reliance on retrospective data, overlapping cohorts, and lack of prospective comparative trials. The LCD continues to exclude IGSRT/HRUS as not reasonable and necessary. Prospective, unbiased trials are required for reconsideration.

Providers submitted extensive literature and practice data opposing exclusion of IGSRT. Cited studies include: Yu 2021–23 (>2,800 lesions, 99.3% control), McClure 2023/24 pooled analyses (IGSRT superior to SRT, non-inferior to Mohs), Farberg 2024 (>20,000 lesions, 6-yr FFR 99.5%), Ma 2024 (efficacy unaffected by SES/comorbidities), Stricker 2024 (92% lesions showed depth change; ~40% required adaptive replanning), and Moloney 2025 (3,000+ lesions, 99% control). Providers argue daily ultrasound is essential for adaptive dosing (≈29–40% lesions need adjustment), that the LCD conflates outdated SRT with modern IGSRT, and that SME panel lacked IGSRT expertise. They cite ECRI 2024’s “Favorable” technology rating and DART 2024 AUC guidelines for BCC/SCC. They assert IGSRT outcomes equal or surpass Mohs in control and cosmesis.

Thank you for your comments. See response to comments # 2-4, and 15.

We acknowledge extensive evidence submissions. While retrospective data is promising, authoritative guidelines (NCCN, AAD, ASTRO, ABS) have not adopted IGSRT as standard of care. Limitations include retrospective design, overlapping cohorts, potential bias, and absence of prospective comparative trials. The LCD maintains IGSRT/HRUS is not reasonable and necessary. Future reconsideration requires prospective controlled studies and updated guideline endorsements.

A smaller set of commenters opposed exclusion of IGSRT without clear identification as patient or provider. Submissions generally 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 response to comments # 2-4, and 15-16.

Commenters strongly support the LCD’s conclusion that HRUS is not reasonable and necessary with SRT. They emphasize no high-quality evidence shows HRUS improves local control, cosmesis, or toxicity; daily ultrasound adds cost/complexity without benefit. Commenters note IGRT is appropriate for deep tumors but not SRT for skin cancer. They stress studies cited by IGSRT proponents are methodologically flawed and do not justify routine use. The commenters highlight their practices high skin cancer burden and commends the LCD for balanced access to SRT for nonsurgical patients without mandating HRUS.

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

ACMS and Mohs surgeons commend MACs for evidence-based policy. They support limiting SRT to nonsurgical candidates with documentation. They strongly endorse exclusions for HRUS/IGSRT and EBT, citing lack of high-quality data, flawed and industry-influenced studies, and publication bias. They note a JAAD study showing ultrasound adds cost without benefit. The commenterstresses IGSRT cure rates reported (>99%) are not credible given study flaws; differences likely due to higher dosing/fractions rather than ultrasound. They support restricting complex simulation/planning codes and confirm most NMSC patients remain appropriate for surgery.

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 submitted supporting the LCD billing and coding article restricting use of codes (77280–77290, 77262–77263, 77333–77336, 77600, 0394T, G6001) with SRT. They stress these codes reflect more complex planning than is required for superficial therapy and were being misused. They endorse the requirement that SRT be performed under physicians with appropriate training (residency/fellowship in radiation oncology or dermatology with documented radiation training). The commenters emphasize qualifications ensure safety and quality.

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

NCCN comments emphasize LCDs should directly incorporate NCCN Guidelines to remain evergreen. They request clarifications: for very high-risk SCC, state surgery/Mohs are valid options (not exclusively Mohs); recognize excision as standard for low-risk BCC/SCC; remove generalized statements in favor of NCCN-specific recommendations. They express concern about routine use of SRT/EBT in non-specialist settings lacking dosimetry/safety oversight. They affirm EBT should only be done by radiation oncologists with physics support in trial/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 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.

A comment submitted supports the LCD and associated billing and coding article. The commenter notes overutilization of IGSRT in community settings appears financially motivated rather than evidence-based. They criticize pay-to-publish IGSRT studies with biased sponsorship, poor design, and lack of long-term follow-up. The commenter emphasizes the importance of aligning Medicare coverage with rigorous peer-reviewed evidence to preserve public trust and commends the LCD for maintaining high evidence standards.

Thank you for your support of the LCD and associated billing and coding article. We appreciate your support of evidence-based decision making and thoughtful feedback and careful review of the LCD and the available literature.

A comment was received from a board-certified dermatologist that served as an SME for the development of this LCD. He voices support to SRT and expresses dismay at the expansion of image guidance. He agrees the LCD is necessary to preserve access for patients and help prevent aggressive/abusive billing practices. He supports the use of SRT as a second-line treatment and notes that true non-surgical candidates are very few. He included a review of literature submitted by proponents of image guidance. The additional literature remains low quality. He also indicated he agrees with provider qualifications. He provided some suggestions for billing and coding as follows:

"1. Simulation code 77280, 77285, 77290 should not be billed with SRT. Simulation services have been defined and valued for internal / metastatic cancers. These services include a CT scanner and integrated targeting software to evaluate complex internal tumor anatomy and planning on how to target the tumor from multiple angles in order to safely and effectively deliver the radiation. There is no simulation that occurs with SRT or IGSRT. Medicare’s National Correct Coding Initiative (NCCI) clarifies that it is “inappropriate to report the best fit HCPCS/CPT code unless it accurately describes the service performed, and all components of the HCPCS/CPT code were performed,” and directs physicians to use unlisted codes.

2. CPT code 77336 should not be billed with SRT delivery at all. Radiation medical physics consultations are designed for complex radiation planning and are not appropriate for the straightforward planning and dosage evaluation associated with SRT. This service also requires on-site evaluation by a radiation physicist, which is not typical for a dermatology office.

3. HCPCS G6001 (ultrasonic guidance), of course, should not be billed with SRT because literature does not support medical necessity as indicated in the body of my letter.

4. CPT 77262 and 77263 which are “Therapeutic radiology treatment planning”, intermediate and complex, respectively, should not be billed for SRT services. These services are designed and valued for extraordinarily intensive planning for treatment of advanced and metastatic internal cancers. They involve ordering and review of advanced imaging as well as significant decisions regarding radiation modality, dosing and targeting that are not performed in SRT. No more than one simple planning code, 77261 should be billed per course of SRT. Treating multiple lesions by SRT does not merit billing of a higher level of complexity planning code.

5. CPT code 77334 Treatment devices, design and construction; complex (irregular blocks, special shields, compensators, wedges, molds or casts) and 77333 Treatment devices, design and construction; intermediate (multiple blocks, stents, bite blocks, special bolus) should not be billed during a course of SRT. Most SRT services are performed without the construction of any shielding device. However, in a small number of cases, a shielding device may be constructed by snipping a lead shield ring that is then used repeatedly for each fraction. At most, CPT 77332 Treatment devices, design and construction; simple (simple block, simple bolus) should be billed once in a course of treatment.

6. CPT code 77600 Hyperthermia, externally generated; superficial (i.e., heating to a depth of 4 cm or less). There is absolutely no literature to support hyperthermia associated with SRT, and coding 77600 with SRT should be prohibited."

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

A comment was received in strong support of the LCD. The commenter provides support for the criteria outlined for when SRT is reasonable and necessary according to guidelines set forth by AAD, ASTRO, and NCCN. They agree that HRUS to guide SRT is not supported by high quality evidence and there is no peer reviewed data that demonstrates benefit and that tumor size does not change meaningfully between treatment fractions. Additionally, they support the policy's specific criteria for when SRT is not appropriate, the provider qualifications as proposed, and the settings in which SRT is performed must comply with radiation protection guidelines, quality assurance, and supervision requirements. They also voice support for the "methodical and guideline-based approach to reviewing the evidence supporting SRT." They "commend the MACs for explicitly excluding case reports, case series, unpublished data, and industry-sponsored abstracts from its evidence base, while placing greater weight on randomized controlled trials, prospective data, and larger retrospective studies with long term follow-up. This reflects a clear understanding of the hierarchy of evidence and avoids overreliance on lower-quality or methodologically flawed studies." They report appreciation for the non-coverage of EBT or IGSRT since they do not have long-term efficacy data, lack comparator arms, and long-term outcomes. The retrospective studies suffer from patient selection bias and short follow-up. Newer studies in support of IGSRT, simulation, and EBT (as noted in the evidence review) are published in "pay-to-publish" journals. These journals are not specific to dermatology or oncology and are either industry-sponsored or authored by individuals with financial ties to IGSRT manufacturers. ACMS has coding suggestions as follows:

1. Recommend prohibiting billing of CPT code 77290 with SRT since simulation services should not be billed with SRT.

2. Prohibit billing of CPT codes 77262, 77333, 77334, and 77427 since these codes were developed for complex radiation therapy such as internal tumors or metastatic disease.

3. "While an Advance Beneficiary Notice (ABN) is not required for statutorily excluded services (GY) and is not valid after-the-fact when not issued prior to a service expected to be denied (GZ), we encourage MACs to promote voluntary use of ABNs in both scenarios."

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

A comment was received from a dermatologist that treats skin cancer. He voices his support of the proposed LCD and agrees that HRUS is not medically necessary. He states the LCD preserves access to SRT while limiting the costly and unproven addition of HRUS.

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

A comment was received offering the full support of Carelon Medical Benefits Management. They state they "commend the proposed LCD for providing clarity on the use of Image-Guided Radiation Therapy" and that they "strongly agree" with the position that HRUS is not necessary for the delivery of SRT. They also state the LCD sets a precedent by not recommending technology that does not have the support of medical literature and the consensus of experts while preserving access to SRT for beneficiaries.

Thank you for your comments and support of the proposed LCD. We appreciate your review and feedback.

The American Brachytherapy Society (ABS) submitted a comment urging reconsideration of the denial of EBT for the treatment of NMSC. They stated that EBT “achieves very high cure rates with excellent safety and cosmesis, comparable to other definitive therapies.” ABS comments that while its 2019/2020 guidelines limited EBT to trials/registries, newer evidence supports reconsideration. They cite Kuo 2023/Barker 2024 (Esteya trial: 34 pts, 94% cosmesis, no recurrences at 5 yrs), Cheng 2024 (205 pts, <1% recurrence, 87% cosmesis at 36 months), Doggett 2023 (180 pts, 7.6 yrs, 98.9% LC). ABS states outcomes comparable to other standard therapies and will update guidelines accordingly. ABS clarifies it does not support HRUS use with SRT, citing insufficient evidence.

Thank you for your comments. See response to comment # 1. The literature references submitted with this comment were of low quality and did not change the recommendations or consensus of the literature.

The American Society for Radiation Oncology (ASTRO) submitted a comment expressing their strong support for the proposed LCD “particularly the provision that deems high resolution ultrasound (HRUS) to guide SRT delivery as not reasonable or medically necessary and not supported by literature.” They go on to state “all the studies cited by those supporting use of HRUS have significant flaws and/or limitations.” ASTRO suggested minor changes in the language of the LCD.

They suggested the phrase “second-line” be changed to “alternative” and in the covered indications section, removing the phrase “when after documentation of shared decision making” to reduce the risk of misinterpretation and unnecessary denials.

Thank you for your support of the LCD. We do not agree with the need for clarification. We appreciate your review of the LCD and the suggested clarificatory language.

A comment was submitted voicing opposition to the elimination of HRUS with SRT because it is "essential" and the providers would be "treating blindly" without the use of ultrasound. The commenter goes on to state the necessity of visualizing the lesion's depth and shape throughout treatment to reduce the risk of "geographic miss and under-treatment". His letter further states "clinical utility should not be judged solely on the presence or absence of randomized trials. In my hands, and in those of many other dermatologists practicing image-guided SRT, this technology makes treatment safer, more effective, and better tailored to the individual patient".

Thank you for your comments. See response to comments #2-4, and 15-16.

A comment was submitted from a dermatologic surgeon who stated baseline HRUS is necessary to determine the depth and breadth of the lesion to assess whether or not SRT is an appropriate treatment. He further states an ultrasound after treatment and again at 6 weeks are necessary to determine whether or not the lesion has responded to treatment. He agrees that multiple ultrasounds throughout the course of treatment are unnecessary; but suggests reimbursement for a minimum of 3 ultrasounds.

Thank you for your comments. See response to comments #2-4, and 15-16.

A comment was received from a radiation oncologist expressing his "strong objection" to the limitation of HRUS during therapy. He states ultrasound helps him to localize the treatment field and adjust the prescription depth for delivery. He suggests "a more balanced approach" that would allow ultrasound guidance weekly or every 5 sessions to maintain benefits as well as decrease overutilization.

Thank you for your comments. See response to comments #2-4, and 15-16.

Comments were submitted opposing the elimination of coverage for EBT. The comments included citations to literature/studies that purport to support EBT as an effective treatment for surgery-ineligible or elderly patients. They go on to state that there is long-term (more than 7 years) follow up in the cited studies (Doggett 2023, Patel 2017, and Paravati 2015) which refutes the LCD assertion that EBT lacks long-term and comparative data. The comments also state that the 2015 American Brachytherapy Society (ABS) consensus statement was misinterpreted and did not prohibit EBT use, but called for continued monitoring and prospective trials. Commenters also provided links to CPT panel decisions regarding coding for EBT: "September 2024 CPT Editorial Panel Summary of Panel Actions, tab 41 (https://www.ama-assn.org/system/files/sept-2024-summary-of-panel-actions.pdf), with the new codes effective in January 2026. A request was submitted to the CPT Editorial Panel in May 2025 to establish separate codes for EBT but the CPT Editorial Panel, with the strong support of ASTRO, voted not to create separate CPT codes for EBT (tab 62, https://www.ama-assn.org/system/files/may-2025-summary-of-panel-actions.pdf), affirming that EBT and surface radiation therapy <150kV (SRT) will be reported under new CPT code 77X07". They also note the 2024 NCCN guidelines support radiation therapy for NMSC and that EBT, as a subset of SRT, falls under this endorsement. Also cited are the AAD and ASTRO guidelines that support SRT in the management of BCC, SCC, and SCCIS. The AAPM, ABS, and ACR recognize EBT as a valid modality. Commenters believe eliminating EBT would create medical care access inequality, remove the option for a non-invasive treatment for frail or elderly patients, override CPT alignment and societal guidance with inconsistent interpretation, mislead providers and patients by leading them to believe EBT is experimental or inferior and diminish patient autonomy. They request the language removing EBT coverage be removed as they believe this therapy should be treated under the same reasonable and necessary framework as SRT (covered under CPT CODE 77X07).

Thank you for your comments. See response to comment #1 and 27.

This contractor acknowledges clinical experience and cited studies. We maintain LCD conclusions are consistent with guidelines, which still do not endorse EBT as standard. Exclusion remains; reconsideration requires prospective trials/registries with mature data.

Radiation oncologists with >10 years of experience in EBT submitted a comment urging reversal of non-coverage. They cite long-term series (Doggett 2023, Patel 2017, Paravati 2015) showing ≥98% LC and cosmesis comparable to Mohs. They argue the LCD misrepresents ABS consensus, omits key studies, and used narrow search terms. They highlight advantages: shorter regimen (8–10 tx), homogeneous dosing on irregular contours, safety, lower cost (75–100% less than electron beam), and better tolerability in elderly. They stress NCCN lists EBT as RT variant and CPT alignment reflects clinical equivalence. They request LCD revision and recognition of EBT as reasonable and necessary.

Thank you for your comments. See response to comment #1 and 27.

Comments were received strongly opposing the elimination of image guidance. The commenters state image guidance is a major advancement that allows the visualization of tumor size, depth, and morphology before each treatment session which allows precise targeting and adaptive dosing, decreasing the risk that malignant tissue is missed. They stated overall control of 99.2% and that the outcomes are comparable to, or surpass tumor control Mohs surgery provides. Commenters believe the LCD only cites a single study (Likhacheva A, Awan M, Barker CA, et al. Definitive and postoperative radiation therapy for basal and squamous cell cancers of the skin: executive summary of an American Society for Radiation Oncology clinical practice guideline. Pract Radiat Oncol. 2020;10(1):8-20.) that refutes the necessity of IGSRT. They state that the LCD "ignores numerous studies on IGSRT that have emerged since" and states that several studies now show that IGSRT produces better control rates and outcomes. They state the Likhacheva study is "irrelevant to any discussion of IGSRT because it is not a study of IGSRT. The study cites 100 references as part of its executive summary of ASTRO's guidelines. However, these references primarily concern external beam radiotherapy, EBT, nodal metastasis, and cisplatin chemotherapy with only 1or 2references pertaining to non-image guided SRT. Notably, not a single reference mentions IGSRT. Thus, issuing coverage requirements for IGSRT based on this study is not justified". They believe image guidance is medically necessary before, during, and after a course of SRT as it allows for precise adjustments based on daily tumor changes. The Stricker study is referenced, which showed that 92% of NMSC lesions exhibit "daily depth fluctuations during therapy" which reinforces the need for daily imaging to make compensatory adjustments. Commenters state randomized clinical studies are not practical or ethical because it would withhold HRUS from a control group receiving only SRT. This would subject the control group to suboptimal and potentially harmful treatment conditions. They believe the NCCN guidelines explicitly endorse radiation therapy as a primary treatment, and the LCD perpetuates the "unsupported narrative" that IGSRT is secondary to surgery. They state that C2C Innovative Solutions, Inc. and "multiple Administrative Law Judges (ALJs)” have issued favorable decisions supporting IGSRT. C2C has issued 18 decisions over the last 5 years and since January 2025, ALJ has issued 5 favorable decisions. Commenters go on to state ALJs have cited "mature data" that shows an increase in control number with IGSRT. They stated C2C and ALJ have relied on the reasonable and necessary criteria in Chapter 3, Section 3.6.2.2 of the Medicare Program Integrity Manual and that the LCD failed to meet the same standards "as it disregards the substantial body of peer-reviewed evidence, expert consensus, and Medicare precedent." Commenters state the MACs "overstep their authority" by eliminating the ability of dermatologists to deliver IGSRT. They question the rationale behind the LCD establishing stricter provider qualifications than the CMS National Coverage Policy. They conclude that the policy disproportionately impacts older adults, those that live in rural areas, or those with limited mobility since they may not be able to travel to hospital-based radiation oncology settings.

Thank you for your comments. See response to comments #2-4, and 15-16.

A comment was submitted opposing the elimination of coverage for EBT. The commenter states the LCD references a flawed article (Consensus Guidelines on the Use of Superficial Radiation Therapy for Treating Nonmelanoma Skin Cancer and keloids) that should be discredited because it was authored by the members of a competitive manufacturer's medical advisory board and did not reference EBT publications that were available at the time. The commenter cites articles that show high "cure" rates in the 90% range and that blanket non-coverage of EBT is not justified.

Thank you for your comments. See response to comment #1 and 27. The articles cited in the comments actually reference local control rates, NOT cure rates.

The research chair at the Dermatology Association of Radiation Therapy (DART) submitted a comment. He expressed his non-support for the proposed LCD. He states the LCD is outdated, bases coverage decisions on obsolete studies that predate key studies, and "ignores" the control rates IGSRT provides. He believes the guidelines from ASTRO focus on other cancer types and omit IGSRT. He goes on to state that recent IGSRT studies from 2023-2025 are not included and the ECRI dataset is not discussed. He believes daily imaging is essential and proven to have 99%+ control rates. "Section 13.5.3 of the Medicare Program Integrity Manual outlines specific evidentiary requirements for LCDs, including a full description of the service, supporting scientific literature, target population, and FDA clearance if applicable. The proposed LCD fails to meet these standards by omitting up-to-date, peer-reviewed research and relying instead on outdated specialty guidelines." He states randomized control trials are not required by Medicare, are impractical, unethical, and unnecessary. He goes on to state Mohs surgery does not show superiority in primary BCCs and has a higher cost. He also raises concern with the 2019 article by Likhacheva (ASTRO clinical practice guideline on RT for basal and squamous cell cancer of the skin), stating that this article does not reference HRUS and contains no evidence for its negative stance. He states IGSRT has "stellar cure rates" and is the gold standard for all early-stage NMSCs whether the patient is a surgical candidate or not, IGSRT is equal to or surpasses Mohs results, HRUS improves control/cure rates.

Thank you for your comments. See response to comments #2-4, and 15-16.

A comment was submitted from the chairman of DART. He states the LCD is outdated and conflates SRT with IGSRT. He believes the improvement in outcomes with the use of HRUS have been extensively proven in multiple studies and that the cure rates are equivalent or greater than those with Mohs. He also states randomized control trials are not practical or ethical for this treatment. This comment also expresses concern that the LCD references "only a single study" and states the Likhacheva study does not relate to IGSRT and should not be used. DART believes the literature supports using IGSRT as a primary treatment for low and high-risk BCC and SCC. DART disagrees with the tumor size and depth limitations set forth in the LCD. They state that BCC and SCC with sizes greater than 4 cm can be treated if the tumor is uniformly thin. They also expressed concern that the LCD indicates SRT should be provided under the supervision of a radiation oncologist, which deviates from current practice of dermatologists "safely and effectively" delivering SRT. They believe the consequences of limiting IGSRT would be a regression in treatment, restricting to radiation oncologists would reduce access to care, and would leave patients (especially in rural areas) with very few options-such as long travel distances, less effective treatment, or foregoing care entirely.

Thank you for your comments. See response to comments #2-4, and 15-16.