Proton Beam Radiotherapy

LCD Information Document Information Source LCD ID N/A LCD ID L33937 Original ICD-9 LCD ID Not Applicable LCD Title Proton Beam Radiotherapy Proposed LCD in Comment Period N/A Source Proposed LCD N/A Original Effective Date For services performed on or after 10/01/2015 Revision Effective Date For services performed on or after 12/16/2019 Revision Ending Date N/A Retirement Date N/A Notice Period Start Date N/A Notice Period End Date N/A CPT codes, descriptions, and other data only are copyright 2025 American Medical Association. All Rights Reserved. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. CPT is a registered trademark of the American Medical Association. 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Issue Issue Description Issue - Explanation of Change Between Proposed LCD and Final LCD CMS National Coverage Policy This LCD supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations for Proton Beam Radiotherapy. Federal statute and subsequent Medicare regulations regarding provision and payment for medical services are lengthy. They are not repeated in this LCD. Neither Medicare payment policy rules nor this LCD replace, modify or supersede applicable state statutes regarding medical practice or other health practice professions acts, definitions and/or scopes of practice. All providers who report services for Medicare payment must fully understand and follow all existing laws, regulations and rules for Medicare payment for Proton Beam Radiotherapy and must properly submit only valid claims for them. Please review and understand them and apply the medical necessity provisions in the policy within the context of the manual rules. Relevant CMS manual instructions and policies may be found in the following Internet-Only Manuals (IOMs) published on the CMS Web site. Internet Only Manual (IOM) Citations: CMS IOM Publication 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.5.4 Reasonable and Necessary Provision in an LCD Social Security Act (Title XVIII) Standard References: Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no Medicare payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury. Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations. Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider for any claim that lacks the necessary information to process the claim. Coverage Indications, Limitations, and/or Medical Necessity History/Background and/or General Information Proton beam radiotherapy is a type of particle beam radiation therapy that delivers high dose radiation to a localized site. Proton beams theoretically deposit less radiation in normal non-targeted tissues than conventional radiation therapy and have been used to escalate the radiation dose to diseased tissues while minimizing damage to adjacent normal tissues. Historically, proton beam radiotherapy has most commonly been used for tumors that are difficult or dangerous to treat with surgery or for tumors that are located next to vital structures, where administration of adequate doses of conventional radiation is difficult or impossible. Covered Indications Proton beam therapy will be considered medically reasonable and necessary for the following conditions: Group #1 Conditions Benign or malignant conditions otherwise not suitable for intensity modulated radiation therapy (IMRT) or 3- dimensional conformal therapy involving the base of the skull or axial skeleton, including but not limited to chordomas and chondrosarcomas. Solid tumors in children up to age 18. Benign or malignant central nervous system tumors to include primary and variant forms of medulloblastoma, astrocytoma, glioblastoma, arteriovenous malformations, acoustic neuroma craniopharyngioma, benign and atypical meningiomas and pineal gland tumors. Intraocular melanomas Because many radiological oncologists believe that proton beam therapy is a legitimate treatment option in certain circumstances where 3-dimensional conformal or intensity modulated radiation therapy (IMRT) is deemed medically necessary, proton beam therapy will be considered as medically reasonable and necessary for certain other conditions (i.e., Group #2 of ICD-10-CM Codes that Support Medical Necessity) not listed above, as long as the following criteria are met: Either #1, #2, or #3 must be present and Either #4 or #5 must be present and #6 must always be present. 1. When dose constraints to normal tissues limit the total dose of radiation safely deliverable to the tumor with other indicated methods 2. When there is a reason to believe that doses generally thought to be above the level otherwise attainable with other methods might improve control rates 3. In circumstances when the higher levels of precision associated with proton beam therapy as compared to other radiation methods are necessary, i.e., clinically relevant 4. For the treatment of primary lesions, the intent of treatment must be curative 5. For the treatment of metastatic lesions, there must be the expectation of a long-term benefit (> 2y) that could not have been attained with conventional therapy the expectation of a complete eradication of the metastatic lesion that could not have been safely accomplished with conventional therapy, as evidenced by a dosimetric advantage for proton beam radiotherapy over other forms of radiation therapy 6. The patient’s record demonstrates why Proton beam radiotherapy is considered the treatment of choice for the individual patient. Specifically, the record must address the lower risk to normal tissue, the lower risk of disease recurrence, and the advantages of the treatment over IMRT or 3-dimensional conformal Dosimetric evidence of reduced normal tissue toxicity and/or improved tumor control must be maintained. If the above provisions are met and the patient is treated in a protocol that is designed for evidence development and for future publication, it is expected that future published data will support an outcome advantage for patients for continued coverage of the specific diagnosis. The protocol in and by itself does not constitute criteria for coverage. The presence of an Institutional Review Board review, when appropriate, and patient informed consent are also expected. Proton beam treatment of the following conditions may be considered medically reasonable and necessary only if the above criteria are met as specified. Group #2 Conditions Malignant lesions of the head and neck when the intent of treatment is to be curative. Malignant lesions of the Para nasal sinus, and other accessory sinuses Malignant lesions of the prostate Malignant advanced stage, non-metastatic tumors of the bladder Advanced pelvic tumors including malignant lesions of the cervix Left breast tumors Pancreatic and adrenal tumors Skin cancer with perineural/cranial nerve invasion Unresectable retroperitoneal sarcoma and extremity sarcoma Cancers of the lung and upper abdominal/peri-diaphragmatic cancers Malignant lesions of the liver, biliary tract, anal canal and rectum Limitations In general, proton beam radiotherapy is not indicated for cancers that are widely disseminated, such as leukemias, have hematogenous metastases or as a short-term palliative procedure. The intent of treatment should be curative. If proton beam radiotherapy is used for a patient with metastatic disease, evidence should be provided to justify the expectation of a long-term benefit (> 2y), as well as evidence of a dosimetric advantage for proton beam radiotherapy over other forms of radiation therapy. All other indications are not considered reasonable and necessary and will be denied. As published in the CMS IOM Publication 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.5.4, an item or service may be covered by a contractor LCD if it is reasonable and necessary under the Social Security Act Section 1862 (a)(1)(A). Contractors shall determine and describe the circumstances under which the item or service is considered reasonable and necessary. Summary of Evidence N/A Analysis of Evidence (Rationale for Determination) N/A

History/Background and/or General Information Proton beam radiotherapy is a type of particle beam radiation therapy that delivers high dose radiation to a localized site. Proton beams theoretically deposit less radiation in normal non-targeted tissues than conventional radiation therapy and have been used to escalate the radiation dose to diseased tissues while minimizing damage to adjacent normal tissues. Historically, proton beam radiotherapy has most commonly been used for tumors that are difficult or dangerous to treat with surgery or for tumors that are located next to vital structures, where administration of adequate doses of conventional radiation is difficult or impossible. Covered Indications Proton beam therapy will be considered medically reasonable and necessary for the following conditions: Group #1 Conditions Benign or malignant conditions otherwise not suitable for intensity modulated radiation therapy (IMRT) or 3- dimensional conformal therapy involving the base of the skull or axial skeleton, including but not limited to chordomas and chondrosarcomas. Solid tumors in children up to age 18. Benign or malignant central nervous system tumors to include primary and variant forms of medulloblastoma, astrocytoma, glioblastoma, arteriovenous malformations, acoustic neuroma craniopharyngioma, benign and atypical meningiomas and pineal gland tumors. Intraocular melanomas Because many radiological oncologists believe that proton beam therapy is a legitimate treatment option in certain circumstances where 3-dimensional conformal or intensity modulated radiation therapy (IMRT) is deemed medically necessary, proton beam therapy will be considered as medically reasonable and necessary for certain other conditions (i.e., Group #2 of ICD-10-CM Codes that Support Medical Necessity) not listed above, as long as the following criteria are met: Either #1, #2, or #3 must be present and Either #4 or #5 must be present and #6 must always be present. 1. When dose constraints to normal tissues limit the total dose of radiation safely deliverable to the tumor with other indicated methods 2. When there is a reason to believe that doses generally thought to be above the level otherwise attainable with other methods might improve control rates 3. In circumstances when the higher levels of precision associated with proton beam therapy as compared to other radiation methods are necessary, i.e., clinically relevant 4. For the treatment of primary lesions, the intent of treatment must be curative 5. For the treatment of metastatic lesions, there must be the expectation of a long-term benefit (> 2y) that could not have been attained with conventional therapy the expectation of a complete eradication of the metastatic lesion that could not have been safely accomplished with conventional therapy, as evidenced by a dosimetric advantage for proton beam radiotherapy over other forms of radiation therapy 6. The patient’s record demonstrates why Proton beam radiotherapy is considered the treatment of choice for the individual patient. Specifically, the record must address the lower risk to normal tissue, the lower risk of disease recurrence, and the advantages of the treatment over IMRT or 3-dimensional conformal Dosimetric evidence of reduced normal tissue toxicity and/or improved tumor control must be maintained. If the above provisions are met and the patient is treated in a protocol that is designed for evidence development and for future publication, it is expected that future published data will support an outcome advantage for patients for continued coverage of the specific diagnosis. The protocol in and by itself does not constitute criteria for coverage. The presence of an Institutional Review Board review, when appropriate, and patient informed consent are also expected. Proton beam treatment of the following conditions may be considered medically reasonable and necessary only if the above criteria are met as specified. Group #2 Conditions Malignant lesions of the head and neck when the intent of treatment is to be curative. Malignant lesions of the Para nasal sinus, and other accessory sinuses Malignant lesions of the prostate Malignant advanced stage, non-metastatic tumors of the bladder Advanced pelvic tumors including malignant lesions of the cervix Left breast tumors Pancreatic and adrenal tumors Skin cancer with perineural/cranial nerve invasion Unresectable retroperitoneal sarcoma and extremity sarcoma Cancers of the lung and upper abdominal/peri-diaphragmatic cancers Malignant lesions of the liver, biliary tract, anal canal and rectum Limitations In general, proton beam radiotherapy is not indicated for cancers that are widely disseminated, such as leukemias, have hematogenous metastases or as a short-term palliative procedure. The intent of treatment should be curative. If proton beam radiotherapy is used for a patient with metastatic disease, evidence should be provided to justify the expectation of a long-term benefit (> 2y), as well as evidence of a dosimetric advantage for proton beam radiotherapy over other forms of radiation therapy. All other indications are not considered reasonable and necessary and will be denied. As published in the CMS IOM Publication 100-08, Medicare Program Integrity Manual , Chapter 13, Section 13.5.4, an item or service may be covered by a contractor LCD if it is reasonable and necessary under the Social Security Act Section 1862 (a)(1)(A). Contractors shall determine and describe the circumstances under which the item or service is considered reasonable and necessary.