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

WPS received a comment from a radiation oncologist and medical director of medical benefits management, stating: “we strongly agree with the LCD's position that high-resolution ultrasound (HRUS) is not necessary for SRT delivery. Clinical evidence does not validate HRUS as a requirement in planning or guiding treatments for NMSC with SRT, nor does it show benefits in enhancing outcomes such as local control or cosmetic improvements. Incorporating HRUS into SRT is likely to increase costs and complexity unnecessarily, without any proven patient benefits.

The proposed LCD sets a sensible precedent by recommending against the integration of technologies lacking robust support from medical literature and expert consensus. We believe that such prudent decisions are critical in preventing the misuse of resources.

Additionally, the proposed LCD provides a well-considered framework for when SRT is covered, ensuring this therapy remains accessible for patients who are unsuitable candidates for surgery or prefer non-invasive alternatives. The proposed guidelines reflect contemporary clinical practices, ensuring SRTs availability in evidence-supported scenarios.”

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

Sensus Healthcare, the manufacturer and distributor of the SRT-100 Vision, which incorporates HFUS into SRT treatment, believes that it is important that we provide our candid response to the proposed LCD. Overall, we generally agree with the LCD’s proposed conditions for SRT patient eligibility and provider qualifications but disagree with the recommendation to completely remove the use of HFUS with SRT. Our mission is to deliver skin cancer therapy that improves tolerability, cosmesis, convenience and the overall patient experience while not sacrificing efficacy. Further, as a manufacturer of radiation therapy systems, we take the over-arching radiation safety rule of ALARA (As Low As Reasonably Achievable) as seriously as any other therapeutic radiation system manufacturer that has advanced their technologies for the purpose of minimizing exposure to organs at risk. Our impetus for developing SRT with HFUS image guidance was (1) the knowledge that NMSC lesions have variable depths, (2) our SRT systems could treat to variable depths, and (3) the only way to know for sure how deep to treat is to image the lesion (as is the case with any other radiation system simulation). Therefore, we paired HFUS with our SRT system to enable physicians to confidently treat to the minimal depth needed to cover the lesion. By removing this uncertainty, physicians would no longer treat to inappropriate depths (either too deep or too shallow). Without the HFUS, one could argue that the “blind” therapy does not satisfy the principles of ALARA. Therefore, we urge you to continue to allow for the HFUS as part of the initial simulation of the lesion. We steadfastly believe that HFUS has a role in treatment monitoring throughout the treatment course. Despite this, we agree with the LCD’s criticism of the cited clinical studies that evaluated SRT with HFUS image guidance in the treatment of NMSC alone or compared to non-image guided SRT, EBRT or Mohs. We do not believe that they are credible clinical studies and, as a company, have withheld from broadcasting any of their results publicly or privately. We want all stakeholders to understand that we are equally bothered by the insinuations of these studies without proper study design and follow-up. Despite this, we are steadfast in our belief in the utility of HFUS with SRT, and we do not believe that these studies serve as proof that HFUS should not be used in concert with SRT. Along with assessing lesion dimensions and nearby organs at risk during initial simulation, HFUS is useful, in our view, in monitoring the response to treatment during and after the completion of the treatment course.

Thank you for your comments. Upon review of the SRT literature the quality of evidence is low to support the use of HRUS with 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 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 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.

WPS, CGS, NGS, Noridian and Palmetto received multiple emails from a DART Advocacy email in opposition to the proposed SRT LCD. 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.

Thank you for your comments. See response to comment #2. The proposed local coverage determination DL40193 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.

WPS, CGS, NGS, Noridian and Palmetto received multiple emails from a DART Advocacy email in opposition to the proposed SRT LCD. These emails have few variations in their content with different provider signatures. The emails consisted of provider Public Comments Opposing Proposed LCD on SRT for NMSC. The letters expressed support for their current use of HRUS IG SRT and that IGSRT is a safe and effective treatment that should remain a covered Medicare benefit in dermatology practices.

See response #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).

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.

WPS received multiple emails from a DART Advocacy email in opposition to the proposed SRT LCD. 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. Thirty-nine (39) of these emails were directed at First Coast Service Options, Inc. (FCSO). 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.

WPS received more than 100 emails from voter voice.net. The emails were in opposition to the proposed SRT LCD. These emails have few variations in their content with different voter signatures. They stated opposition to the Medicare Administrative Contractors (MACs) Proposed Local Coverage Determination (LCD) - Superficial Radiation Therapy (SRT) for the Treatment of Nonmelanoma Skin Cancers. They urge to preserve coverage for Image Guided Superficial Radiation Therapy (IGSRT), a greater than 99% cure rate, non-invasive treatment for nonmelanoma skin cancer (NMSC), the most common type of cancer in the United States. They say: “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 DL40193 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.

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 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.

We received comments that oppose the proposed changes to coverage for per-treatment ultrasound imaging in Image-Guided Superficial Radiation Therapy (IGSRT) for non-melanoma skin cancers. She emphasizes the clinical necessity of this imaging, which enhances treatment precision by adapting to real-time changes in tumor characteristics. Kopiecki cites studies demonstrating high cure rates with IGSRT and highlights the importance of ultrasound for accurate dosing and protecting healthy tissue. She also references professional standards set by ARRT and ASRT supporting the use of imaging in treatment. She urges 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 HRUS with 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 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 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.

We received comments that argue 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 criticize the LCD for not addressing the root cause of billing overutilization and for relying on flawed studies to restrict HFUS. Sensus advocates 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 #3. The proposed local coverage determination DL40193 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.

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. The dermatologist supports the draft Local Coverage Determination (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 #4.

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 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. We appreciate your review of the LCD and your suggestions for language clarification. WPS recognizes that standard excision is also 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 a comment from a practicing dermatologist in OH who provides radiation therapy in their office. He states the use of the therapy has saved many patients from the morbidity of Mohs surgery or large tumors in cosmetically sensitive areas. He supports ultrasound guidance for delivery of radiation therapy, requests to ensure dermatologists are not excluded from overseeing radiation services and concludes medical necessity of electronic brachytherapy. He requests 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 local coverage determination DL40193 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.

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

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

A comment was received from a radiation oncologist with extensive experience in use of ultra-sound guided SRT and electronic brachytherapy in the outpatient setting. He argues there is sufficient literature to support as reasonable and necessary, and the service is safe and effective first line treatment for appropriately selected cases of NMSC. He states the benefit of ultrasound guidance and refers to 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 requirements. He states the policy may lead to increased surgical management, in hospital radiation treatment, suboptimal office treatments, increase health care disparities and access issues and undermining multidisciplinary care.

Thank you for your comments. See response to comments #2, 3, 7, 14.

The commenter states 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. The commenter is concerned that the use of image guided SRT is egregious misuse. They state there is a role of SRT in skin cancer treatment the additional of image guidance is does not improve outcomes, side effects or patient experience, but substantially increase cost. They request continued reimbursement for superficial radiation therapy but restrict or eliminate the reimbursement for superfluous image guidance.

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

"I am a Dermatologist and 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. CGS appreciates your careful review of the LCD and thoughtful feedback.

Providers strongly oppose LCD DL40176 exclusion of EBT. Report 8–12 years of real-world practice experience with thousands of patients. Argue EBT is FDA-cleared, non-invasive, safe for elderly and high-risk patients, with excellent cosmesis and minimal downtime. Stress that 5-year local control rates rival Mohs surgery, with recurrence in the low single digits. Cite studies: Doggett 2023 (7.6 yr FU, 98.9% LC), Patel 2017 (matched-pair vs Mohs, non-inferior outcomes), Cheng 2024 (post-market Esteya study, <1% recurrence, 87% good cosmesis). 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 #8.

Industry commenters strongly oppose the exclusion of EBT. Elekta requests removal of all EBT references, arguing 2019 consensus guidelines were flawed and excluded EBT experts. Provide publications: Doggett 2023, Patel 2017, Cheng 2024, showing >98% LC, non-inferior to Mohs, favorable cosmesis. Highlight 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 #8.

Radiation oncologists with >10 years of experience in EBT urge reversal of non-coverage. Cite long-term series (Doggett 2023, Patel 2017, Paravati 2015) showing ≥98% LC and cosmesis comparable to Mohs. Argue LCD misrepresents ABS consensus, omits key studies, and used narrow search terms. 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. Stress NCCN lists EBT as RT variant and CPT alignment reflects clinical equivalence. Request LCD revision and recognition of EBT as reasonable and necessary.

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

Patients strongly oppose Local Coverage Determination DL40193 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 # 8-10. The proposed Local Coverage Determination DL40193 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.

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), Moloney 2025 (3,000+ lesions, 99% control). Providers argue daily ultrasound is essential for adaptive dosing (≈29–40% lesions need adjustment), that 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. Assert IGSRT outcomes equal or surpass Mohs in control and cosmesis.

Thank you for your comments. See response to comments #9-11 and 22.

A smaller set of commenters opposed the 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 #8-10 and 22.

Commenters strongly support the LCD’s conclusion that HRUS is not reasonable and necessary with SRT. Emphasize no high-quality evidence shows HRUS improves local control, cosmesis, or toxicity; daily ultrasound adds cost/complexity without benefit. Carelon notes IGRT is appropriate for deep tumors but not SRT for skin cancer. ASTRO stresses studies cited by IGSRT proponents are methodologically flawed and do not justify routine use. Arizona Oncology highlights Tucson’s 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. Support limiting SRT to nonsurgical candidates with documentation. Strongly endorse exclusions for HRUS/IGSRT and EBT, citing lack of high-quality data, flawed and industry-influenced studies, and publication bias. Note JAAD study showing ultrasound adds cost without benefit. Rogers stresses IGSRT cure rates reported (>99%) are not credible given study flaws; differences likely due to higher dosing/fractions rather than ultrasound. Both 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.

Support LCD billing and coding article restricting use of codes (77280–77290, 77262–77263, 77333–77336, 77600, 0394T, G6001) with SRT. Stress these codes reflect more complex planning than is required for superficial therapy and were being misused. Endorse requirement that SRT be performed under physicians with appropriate training (residency/fellowship in radiation oncology or dermatology with documented radiation training). 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. 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. Express concern about routine use of SRT/EBT in non-specialist settings lacking dosimetry/safety oversight. 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 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.

Supports LCD and associated billing/coding article. Notes overutilization of IGSRT in community settings appears financially motivated rather than evidence based. Criticizes pay-to-publish IGSRT studies with biased sponsorship, poor design, and lack of long-term follow-up. Emphasizes the importance of aligning Medicare coverage with rigorous peer-reviewed evidence to preserve public trust. Commends LCD for maintaining high evidence standards.

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

WPS received a comment 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 that 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 (CCI) 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 not appropriate for the straightforward planning and dosage evaluation associated with SRT. This service also requires the 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 the 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.

WPS received a comment in strong support of the LCD. The comment 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 are 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, 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. WPS appreciates your coding recommendations.

WPS received a comment 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. WPS appreciates your careful review of the LCD and thoughtful feedback.

WPS received a comment 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 the access to SRT for beneficiaries.

Thank you for your comments and support of the proposed LCD. WPS appreciates your review and feedback.

WPS received a comment from the American Brachytherapy Society (ABS) urging reconsideration of the denial of electronic brachytherapy (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. 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. Clarifies ABS does not support HRUS use with 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.

WPS received a comment from The American Society for Radiation Oncology (ASTRO) 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. WPS does not agree with the need for clarification. We appreciate your review of the LCD and the suggested clarificatory language.

Opposition to the elimination of HRUS with SRT because it is "essential" and the providers would be "treating blindly" without the use of ultrasound. He 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, 9, 10, and 14.

WPS received a comment 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, 9, 10, and 14.

WPS received a comment 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, 9, 10, and 14.

WPS received a comment opposing the elimination of coverage for EBT. The comment included citations to literature/studies that purport to support EBT as an effective treatment for surgery-ineligible or elderly patients. He goes on to state that there is long-term (more than 7 years) of 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 comment also states 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. He 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". He also notes 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. The commenter believes 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, diminish patient autonomy. He requests the language removing EBT coverage be removed as he believes 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 comments #8 and 19-21.

WPS received a comment strongly opposing the elimination of image guidance. The comment states 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. He stated overall control of 99.2% and that the outcomes are comparable to or surpass tumor control Mohs surgery provides. He believes 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. He states 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. He states 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 one or two references 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". He believes image guidance is medically necessary before, during, and after a course of SRT and allows for precise adjustments based on daily tumor changes. He states that the Stricker study showed that 92% of NMSC lesions exhibit "daily depth fluctuations during therapy" which reinforces the need for daily imaging to make compensatory adjustments. He states 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. He believes the NCCN guidelines explicitly endorse radiation therapy as a primary treatment and the LCD perpetuates the "unsupported narrative" that IGSRT is secondary to surgery. He states 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. He goes on to state ALJs have cited "mature data" that shows an increase in control number with IGSRT. He stated C2C and ALJ have relied on the reasonable and necessary criteria in Chapter3, 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." The commenter states the MACs "overstep their authority" by eliminating the ability of dermatologists to deliver IGSRT. He questions the rationale behind the LCD establishing stricter provider qualifications than the CMS National Coverage Policy. He concludes 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, 9, 10, and 14.

WPS received a comment opposing the elimination of coverage for EBT. She states the LCD references a flawed article (Consensus Guidelines on the Use of Superficial Radiation Therapy for Treating Nonmelanoma Skin Cancer and keloids-#12 on LCD bibliography) 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. She cites articles (including # 21, 23 in the LCD bibliography) that show high "cure" rates in the 90 percent range and that blanket non-coverage of EBT is not justified.

Thank you for your comments. See response to comments #8 and 19-21. The articles cited in the comments actually reference local control rates, NOT cure rates.

WPS received a comment from the research chair at DART. 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, 9, 10, and 14.

WPS received a comment 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 size greater than 4cm 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, 9, 10, and 14.