LCD Reference Article Response To Comments Article

Response to Comments: Radiation Therapies

A59965

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A59965
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Response to Comments: Radiation Therapies
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Response to Comments
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03/23/2025
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The comment period for the Radiation Therapies DL39553 Local Coverage Determination (LCD) began on 08/29/2024 and ended on 10/12/2024. The notice period for L39553 begins on 1/23/25 and will become effective on 3/9/25.

The comments below were received from the provider community.

Response To Comments

Number Comment Response
1

The National Comprehensive Cancer Network® (NCCN®) appreciates the opportunity to comment on the Proposed Local Coverage Determination (LCD) - Radiation Therapies (DL39553) as it relates to NCCN's mission of improving and facilitating, quality, effective, equitable, and accessible cancer care. NCCN will focus our comments on our guideline recommendations in relation to the proposed LCD as well as ways NCCN content can be used as a resource to inform coverage determinations, keep LCDs evergreen as the science evolves, and ensure Medicare beneficiaries have access to the highest standard of possible.

NCCN Background

As an alliance of 33 leading academic cancer centers in the United States that treat hundreds of thousands of patients with cancer annually, NCCN® is a developer of authoritative information regarding cancer prevention, screening, diagnosis, treatment, supportive care, and survivorship care that is widely used by clinical professionals and payers alike. The NCCN Clinical Practice Guidelines in Oncology® (NCCN Guidelines®) are a comprehensive set of guidelines detailing the sequential management decisions and interventions that currently apply to 97 percent of cancers affecting patients in the United States.

NCCN develops authoritative information regarding cancer prevention, screening, diagnosis, treatment, and supportive care that is widely used by clinical professionals and payers alike. The NCCN Guidelines are a comprehensive set of 88 guidelines detailing the sequential management decisions and interventions across 228 algorithms that currently apply to 97 percent of cancers affecting patients in the United States. More than 1900 panel members pa1iicipate in Guideline development. In 2023, there were over 15 million downloads of the Guidelines across web-based and mobile applications. NCCN Guidelines are developed by multidisciplinary expert panels from NCCN Member Institutions in an evidence-based process integrated with expert consensus. The NCCN Guidelines are updated at least annually, but quite often are updated more frequently, with 210 total version updates across all guidelines in 2023.

NCCN imposes strict policies to shield the guidelines development processes from external influences. The "firewall" surrounding the NCCN Guidelines processes includes: financial support policies; panel participation and communication policies; guidelines disclosure policies; and policies regarding relationships to NCCN's other business development activities. The guidelines development is supported exclusively by the Member Institutions' dues and does not accept any form of industry or other external financial support for the guidelines development program.

Proposed LCD Changes

NCCN agrees with the requestor of this LCD revision that a blanket restriction of Stereotactic Radiosurgery (SRS) for brain metastases in the setting of small cell lung cancer is contrary to the NCCN Clinical Practice Guidelines for Small Cell Lung Cancer® version 2.2025. NCCN appreciates Palmetto's proposal to remove the diagnosis of small-cell carcinoma as a limitation in SRS coverage. NCCN supports this proposal as it will allow for alignment of radiation treatment recommendations with both an individual's unique presenting clinical scenario and current evidence-based expert consensus-driven guideline recommendations.

NCCN also respectfully notes that our clinical practice guidelines update on a continual basis, and that the most recent versions of NCCN Guidelines can always be found on www.nccn.org. Guideline-adherent care has consistently been shown to be associated with improved clinical outcomes, as well as decreased costs to payers and patients.1,2,3,4 Additionally, the library of NCCN Compendia, which provides Guideline-related information in a tabular and searchable format, is continuously updated to align with the most recent versions of the NCCN Guidelines. In this specific LCD scenario, the NCCN Radiation Therapy Compendium, which includes all recommended radiation modalities within the NCCN Guidelines, as well as clinical parameters, may be useful as an evergreen reference resource.

NCCN again appreciates the opportunity to comment on the Proposed Local Coverage Determination (LCD) - Radiation Therapies (DL39553). NCCN is happy to serve as a resource and looks forward to working together to ensure Medicare beneficiary access to high-quality cancer care.

References were provided for review.

Thank you for your comments on this LCD reconsideration regarding the restriction for small cell carcinoma.

2

On behalf of the National Association for Proton Therapy (NAPT), thank you for the opportunity to provide feedback on the proposed local coverage determination (LCD) on Radiation Therapies (DL39553) published for public comment by Palmetto GBA on August 29, 2024. We are providing comments to ensure patients with cancer have access to appropriate radiation oncology treatments.

NAPT is an independent nonprofit organization founded in 1990 to educate and increase awareness about the clinical benefits of proton therapy. Its members include 49 of the nation’s leading cancer centers, many of which are NCI-designated comprehensive cancer centers and NCCN members.1 The mission of NAPT is to work collaboratively to raise public awareness of proton therapy, ensure patient choice and access to affordable treatment, and encourage cooperative research and innovation to advance proton therapy’s appropriate and cost-effective utilization.

Proton therapy, or proton beam therapy, is a radiation treatment modality that has the proven ability to reduce side effects for patients by limiting the amount of normal tissue exposed to radiation.2,3 Unlike conventional x-ray radiation, which has both entrance and exit doses, proton therapy delivers radiation to the target, with little to no radiation extending beyond the target. In addition to these acute and late toxicity benefits of proton therapy over conventional radiation therapy, proton beam therapy has been shown across multiple disease sites to improve overall survival, either by reducing life-threating toxicities, being more biologically potent at tumor killing, or allowing for more targeted and escalated doses of irradiation to be delivered directly to the tumor. More than 900 publications have validated the efficacy of proton therapy – showing lower tumor recurrence rates, higher survival rates, fewer short- term and late toxicities, and better preservation of patient quality-of-life both during and after treatment.4 The overwhelming majority of proton centers are multi-modality health centers, utilizing a variety of treatment options to ensure patients receive the most beneficial cancer therapy based on their specific needs.

Our comments on the proposed LCD - Radiation Therapies (DL39553) are twofold and address the following:

  • the non-coverage of Intensity-Modulated Radiation Therapy (IMRT) and proton beam therapy combined treatment; and
  • the lack of coverage for Stereotactic Radiosurgery (SRS) for brain metastases with primary diagnosis of small cell carcinomas.

The non-coverage of IMRT and proton beam therapy combined treatment

NAPT remains concerned by the non-coverage position on intensity-modulated radiation therapy (IMRT) used in conjunction with proton beam radiation therapy in the proposed LCD, as we previously commented in the summer of 2023. There is a long history, and many peer-reviewed publications, describing combined proton and photon radiation plans in diverse diseases.

These studies outline a number of reasons why treated patients have received combined proton and photon radiation treatment plans, including but not limited to equipment downtime or periods of unavailability of proton therapy5, limited availability of pencil-beam scanning6, as a planned twice-daily radiation regimen using both modalities7, to reduce the radiation dose to skin when treating with passively scattered proton radiation8, and to reduce the dosimetric impact of spine stabilization hardware.9

Combined modality treatment plans are also of interest to address resource constrained settings with limited access to gantry-based proton therapy treatment slots, and to optimize utilization of lower-cost fixed horizontal beam lines for proton therapy. Several studies have explored combined photon-proton radiation plans for patients with locally advanced non-small lung cancer10, breast cancer11, and head and neck cancer12, finding that optimally combined photon-proton treatment plans could improve treatment plan quality and make proton therapy available to more patients.

Independent of limited resource allocation, novel treatment planning optimization approaches with mixed protons and photons suggest that new approaches can improve treatment plan quality by combining both radiation modalities in diverse disease sites including abdomen, lung, head and neck, and brain.13 Such hybrid plans would only be possible when it is clinically feasible to deliver either photon or proton treatment on a day-to-day basis.

This proposed non-coverage position could restrict physicians from optimizing radiation treatment plans for select Medicare beneficiaries where the combination therapy is reasonable and necessary. NAPT is concerned that this restriction could impede the appropriate care of certain complex patients with a variety of tumors who need urgent initiation of treatment or continuation of care when proton therapy is not available. This is especially important for patients with tumors such as head and neck, lung, and GI when treatment start time is critical and can impact local tumor control in patient outcomes. If this LCD is finalized, as proposed, please consider one or more exceptions for combined therapy that is necessary for limited practical reasons that are appropriately documented by the rendering provider.

Lastly, the literature cited by Palmetto to support this proposed non-coverage position, a paper by Morgan et al., is the 2018 ASTRO/ASCO/AUA practice guideline on hypofractionated radiation for prostate cancer. That guideline is not about radiation modalities and makes no comments about combining IMRT and proton therapy for prostate cancer.

The lack of coverage for SRS for brain metastases with primary diagnosis of small cell carcinomas

NAPT would also like to provide a comment on the current LCD L39553 regarding the lack of coverage for SRS for brain metastases with primary diagnosis of small cell carcinomas.

The NCCN decided that SRS may be used for selected patients with a small number of brain metastases based on available data and pending outcomes of the ongoing trials. In patients who develop brain metastases after PCI, SRS (preferred) or repeat whole-brain RT (in carefully selected patients) may be considered. Clinical trial NCT04804644 (SRS vs HA-WBRT for patients with SCLC mets) is open and accruing at a modest pace with a primary endpoint of cognitive function (not OS or brain-progression free survival).

A blanket restriction of SRS for brain metastases in the setting of small cell lung cancer is contrary to the NCCN guidelines outlined above. Radiation oncologists around the country are using SRS for SCLC patients with limited brain metastatic disease and it can be very difficult to recommend whole brain therapy in select cases. NAPT would ask that the “small cell carcinoma” language be removed from the third bullet point under SRS for “Indications and Limitations of Coverage and/or Medical Necessity” to allow for treatment with SRS in these appropriate clinical cases. Please see attached NCCN guidelines for SCLC.

Radiation therapies must be made available to patients who need it most. Our members value the responsible use of proton, photon, and SRS therapy and participate in multi-institutional research efforts demonstrating improved outcomes for patients.

References were provided for review.

Thank you for your comments. Palmetto GBA can only respond to the comments regarding the removal of the diagnosis of small cell carcinoma as a limitation in SRS coverage. The restriction to the treatment of small cell carcinoma has been removed.

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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
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L39553 - Radiation Therapies
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