Sunflower Health Plan Stereotactic Body Radiation Therapy (PDF) Form

Stereotactic body radiation therapy (SBRT) and stereotactic radiosurgery (SRS) are radiation therapies delivered via stereotactic guidance to a small, precise target. Both largely spare the surrounding tissue by converging multiple non-parallel radiation beams into one sharply defined target, thereby greatly reducing the amount of radiation to which the surrounding tissue is exposed. SBRT is used to treat extra-cranial sites and can be performed in one to five sessions (fractions). SRS is used to treat intra-cranial and spinal targets. SRS is typically performed in a single session but can be performed in a limited number of sessions, up to a maximum of five. Gamma-ray photons, X-ray photons, protons, helium ions, and neutrons have all been used for SBRT and SRS. Note: For criteria applicable to Medicare plans, please see MC.CP.MP.22 Stereotactic Body Radiation Therapy. Policy/Criteria I. It is the policy of non-Medicare health plans affiliated with Centene Corporation® that up to five sessions of stereotactic body radiation therapy (SBRT) are medically necessary for any of the following indications: A. Early stage non-small cell lung cancer (i.e., stage I through II, NO) as an alternative to surgery; B. Acoustic neuroma; C. Localized malignant conditions in the body where highly precise application of high-dose radiotherapy is required, including tumors of any type arising in or near previously irradiated regions; D. Recurrences of metastatic spine cancer after previous radiation;21 E. Hepatocellular carcinoma, as an alternative to ablation/embolization techniques or when these therapies have failed or are contraindicated; F. Recurrent malignant disease requiring palliation and/or as palliative treatment for liver- related symptoms; G. Low to intermediate risk localized prostate cancer; H. High risk prostate cancer when combined with androgen deprivation therapy, when delivering longer courses of external beam radiation therapy would present a documented hardship; I. Inoperable spinal tumors causing compression or intractable pain; J. Pancreatic adenocarcinoma: 1. Locally advanced disease, without distant metastases; 2. Combination therapy not feasible; 3. Isolated local recurrence, respecting normal organ tolerance. K. Extracranial oligometastatic disease, all of the following: 1. One to three metastatic lesions involving the lungs, liver or bone; Page 1 of 11 CLINICAL POLICY Stereotactic Body Radiation Therapy 2. Primary tumor is breast, colorectal, melanoma, non-small cell lung, prostate, renal cell, or sarcoma; 3. Primary tumor is controlled; 4. No prior history of metastatic disease. II. It is the policy of non-Medicare health plans affiliated with Centene Corporation that up to five sessions of stereotactic radiosurgery (SRS) are medically necessary for any one of the following indications: A. Cranial indications when unresectable due to deep intracranial location or member/enrollee is unable to tolerate conventional operative intervention, one of the following: 1. Inoperable, small (≤ 3 cm) arteriovenous (AV) malformations, 2. Benign tumors including meningiomas, pituitary adenomas, craniopharyngiomas, hemangiomas, and neoplasms of the pineal gland; B. Small acoustic neuromas (≤ 3 cm) or enlarging neuromas in patients who are not candidates for surgery; C. Brain malignancies, primary and/or metastatic lesions; D. Intracranial lesions where the patient refuses surgery; E. Severe, sustained trigeminal neuralgia not responsive to other treatments, F. Booster treatment for larger cranial or spinal lesions that have been treated initially with external beam radiation therapy or surgery. Avoid when in close proximity to cranial nerves II and VIII if the maximal dose delivered exceeds 10 Gy; G. Relapse in previously irradiated cranial or spinal field where additional stereotactic precision is required to avoid unacceptable vital tissue radiation; H. Inoperable spinal tumors causing compression or intractable pain; I. Refractory epileptic seizures in children when the lesion is located where a conventional surgical approach is technically difficult or excessively risky.35 III. It is the policy of non-Medicare health plans affiliated with Centene Corporation® that there is insufficient evidence to support more than five sessions of SBRT or SRS for indications other than those listed above. Background Stereotactic body radiation therapy or stereotactic ablative therapy (SBRT) and stereotactic radiosurgery (SRS) both pair a high degree of anatomic targeting accuracy and reproducibility with very high doses of extremely precise, externally generated, ionizing radiation to inactivate or eradicate a defined target(s). The target is defined by high resolution stereotactic imaging. The procedure involves a multidisciplinary team often consisting of a surgeon, radiation oncologist, radiologist, medical radiation physicist, dosimetrist, radiation therapist, radiation therapy nurse and a specialist of the disease site such as a neurologist.2 Stereotactic describes a procedure during which a target lesion is localized relative to a fixed 3-D reference system, such as a rigid head frame affixed to a patient, fixed bony landmarks, a system of implanted fiducial markers, or other similar system. This localization procedure allows physicians to perform image-guided procedures with a high degree of accuracy and precision.2 Page 2 of 11 CLINICAL POLICY Stereotactic Body Radiation Therapy The risk of developing permanent damage following SRS varies by the location of the lesion in the brain. Lesions located deep in the gray matter (thalamus, basal ganglia) or brainstem (pons, midbrain) carry the maximum risk of neurologic complications. Complications are less likely with lesions in the frontal and temporal lobes. Fractionated radiation therapy is often preferred to SRS for the treatment of lesions in the deep gray matter or the brainstem. Technologies that are used to perform SBRT and SRS include Gamma Knife®, LINAC (linear accelerator), CyberKnife® and proton beam or heavy-charged-particle radiosurgery. In order to enhance precision, various devices may incorporate robotics and real time imaging.3 Gamma Knife Standard gamma knife uses 192 or 201 beams of highly focused gamma rays all aiming at the target region. The Gamma Knife is ideal for treating small to medium size lesions.15 Linear accelerator- (LINAC) LINAC machines deliver high-energy x-rays, also known as photons. It can provide treatment on larger tumors in a single session or during multiple sessions (fractionated SRT). The principles of LINAC are identical to GammaKnife.3,10,15 CyberKnife This device combines a mobile LINAC machine with an image guided robotic system that delivers either a single large dose or fractionated radiation therapy. The overall length of time of treatment on a CyberKnife is typically longer than with other radiation therapy modalities.3,9 Proton Beam There is limited use of proton beam in North America; however, the number of centers has dramatically increased in the last several years.15 Protons are atoms that carry a positive charge. Compared to the use of photons (x-rays), the energy from protons conforms to the tumor better and causes less damage to the surrounding tissue. This allows a greater dose of radiation to be used due to minimizing the effects to normal tissue.30 The National Comprehensive Cancer Network (NCCN) states that SBRT/extremely hypofractionated image-guided intensity-modulated radiation therapy (IMRT) regimens (6.5 Gy per fraction or greater) can be considered as an alternative to conventionally fractionated regimens in the treatment of prostate cancer at clinics with appropriate technology, physics, and clinical expertise. Longer follow-up and prospective multi-institutional data are required to evaluate longer-term results, especially because late toxicity theoretically could be worse in hypofractionated regimens compared to conventional fractionation (1.8 Gy to 2.0 Gy).11 Results from a study comparing the efficacy of SBRT plus androgen deprivation therapy (ADT) to fractionated radiotherapy plus ADT in higher risk prostate cancer support recent NCCN guideline updates, which include SBRT as a non-preferred option for higher risk biological males. Findings demonstrated no difference in survival between SBRT + ADT and standard of care external beam radiation therapy + ADT for high risk prostate cancer.40 Page 3 of 11 CLINICAL POLICY Stereotactic Body Radiation Therapy The World Health Organization notes the following information regarding Grade I meningiomas: stereotactic or image guided therapy is recommended when using tight margins or when close to critical structures.21 A revision to the metastatic spine guideline notes that in selected cases or recurrences after previous radiation, SBRT is appropriate.21 Definitive radiation therapy, particularly SBRT, is recommended for individuals with early stage non-small cell lung cancer (i.e., stage I through II, NO) who are medically inoperable or those who refuse surgery.22 SBRT for the treatment of pancreatic adenocarcinoma should be delivered at an experienced high-volume center with technology that allows for image-guided radiation therapy or in a clinical trial .23 Most recent guidelines from NCCN on the principles of radiation therapy note that data are limited to support radiation therapy recommendations for locally advanced disease. The guidelines include SBRT as an “option” in select patients with pancreatic adenocarcinoma with good performance status and locally advanced disease without systemic metastasis. Chemo radiation or SBRT may also be an option in select patients who are not candidates for combination therapy, an option in disease progression when SBRT had not been previously given, and as an option for isolated local recurrence. SBRT should be avoided if direct invasion of the bowel or stomach is observed on imaging and/or endoscopy.23 SBRT can be considered in patients with hepatocellular carcinoma, as an alternative to ablation/embolization techniques or when these therapies have failed or are contraindicated. SBRT (1 to 5 fractions) is often used for patients with 1 to 3 tumors. SBRT could be considered for larger lesions or more extensive disease, if there is sufficient uninvolved liver and liver radiation tolerance can be respected. There should be no extrahepatic disease, or it should be minimal and addressed in a comprehensive management plan. (Category 2B recommendation) 24 There is currently insufficient evidence to recommend SBRT for treatment of head and neck cancers, however, it might be beneficial for palliation or for older adults. When using SBRT techniques in reirradiation, selection of patients who do not have circumferential carotid involvement is advised. The best outcomes are seen in patients with smaller tumors and no skin involvement.32 A systematic review and meta-analysis of 32 retrospective studies published between 1999 and 2019 demonstrated that the effectiveness and safety of stereotactic radiosurgery (SRS) for brainstem metastases (BSM) was comparable to SRS for nonbrainstem brain metastases. Death related to BSM progression following treatment with SRS was rare and patients often experienced symptomatic improvement. Based upon the apparent effectiveness and safety of SRS for BSM in the context of acute morbidity or death from BSM growth, consideration of SRS on emerging trials of targeted therapy for nonbrainstem brain metastases should be considered.38 The American Academy of Neurology states there is insufficient evidence to make recommendations regarding the use of gamma knife thalamotomy in the treatment of essential Page 4 of 11 CLINICAL POLICY Stereotactic Body Radiation Therapy tremor.25 Per UpToDate, “Gamma knife thalamotomy has not generally been adopted for essential tremor due to concerns about delayed radiation side effects, including risk of radiation necrosis and a theoretical risk of secondary tumor formation.”29 Gamma knife stereotactic radiosurgery can offer a less invasive approach for resection of medial temporal structures in mesial temporal sclerosis (MTS) by allowing increased preservation of tissue. SRS may be an excellent option for patients unwilling to undergo invasive open surgical treatment of MTS. Further randomized trials are ongoing to assess the continued efficacy and outcomes of SRS as a treatment option in patients with MTS.39 Per UpToDate on seizures and epilepsy in children, “Stereotactic radiosurgery may be helpful for selected cases when the lesion is located where a conventional surgical approach is technically difficult or excessively risky. More information is needed on long-term outcome before wider application of this procedure.”35 American Society for Radiation Oncology (ASTRO), the American Society of Clinical Oncology (ASCO), and the American Urological Association (AUA) Per a recent new guideline on hypofractionated radiation therapy for localized prostate cancer from ASTRO, ASCO, and the AUA, “Based on high-quality evidence, strong consensus was reached for offering moderate hypofractionation across risk groups to patients choosing external beam radiation therapy. The task force reached a weaker consensus for ultrahypofractionated radiation therapy. Extremely hypofractionated radiation therapy, also known as ultrahypofractionation, SBRT or stereotactic ablative radiation therapy (SABR) may be offered for low and intermediate risk prostate cancer, but strongly encourages treatment of intermediate- risk patients on a clinical trial or multi-institutional registry. For high-risk disease, the panel does not suggest offering ultrahypofractionation outside of a trial or registry.”31 Recommendations for ultrahypofractionation were graded by the panel as conditional, reflecting the limited base of current evidence on this approach. The guideline recommends large-scale randomized clinical trials and stresses the importance of shared decision making between clinicians and patients.31 Coding Implications This clinical policy references Current Procedural Terminology (CPT®). CPT® is a registered trademark of the American Medical Association. All CPT codes and descriptions are copyrighted 2020, American Medical Association. All rights reserved. CPT codes and CPT descriptions are from the current manuals and those included herein are not intended to be all-inclusive and are included for informational purposes only. Codes referenced in this clinical policy are for informational purposes only. Inclusion or exclusion of any codes does not guarantee coverage. Providers should reference the most up-to-date sources of professional coding guidance prior to the submission of claims for reimbursement of covered services. CPT® Codes 61796 Stereotactic radiosurgery (particle beam, gamma ray, or linear accelerator); 1 simple cranial lesion 61797 Stereotactic radiosurgery (particle beam, gamma ray, or linear accelerator); each additional cranial lesion, simple 61798 Stereotactic radiosurgery (particle beam, gamma ray, or linear accelerator); 1 complex cranial lesion Page 5 of 11 CLINICAL POLICY Stereotactic Body Radiation Therapy CPT® Codes 61799 Stereotactic radiosurgery (particle beam, gamma ray, or linear accelerator;) each additional cranial lesion, complex 61800 Application of stereotactic headframe for stereotactic radiosurgery (List separately in addition to code for primary procedure) 63620 Stereotactic radiosurgery (particle beam, gamma ray, or linear accelerator); 1 spinal lesion 63621 Stereotactic radiosurgery (particle beam, gamma ray, or linear accelerator); each additional spinal lesion 77371 Radiation treatment delivery, stereotactic radiosurgery (SRS), complete course of treatment of cranial lesion(s) consisting of 1 session; multi-source cobalt 60 based 77372 Radiation treatment delivery, stereotactic radiosurgery (SRS), complete course of treatment of cranial lesion(s) consisting of 1 session; linear accelerator based 77373 Stereotactic body radiation therapy, treatment delivery, per fraction to 1 or more lesions, including image guidance, entire course not to exceed 5 fractions 77432 Stereotactic radiation treatment management of cranial lesion(s) (complete course of treatment consisting of 1 session) 77435 Stereotactic body radiation therapy, treatment management, per treatment course, to 1 or more lesions, including image guidance, entire course not to exceed 5 fractions HCPS G0339 G0340 Image-guided robotic linear accelerator-based stereotactic radiosurgery, complete course of therapy in one session or first session of fractionated treatment Image-guided robotic linear accelerator-based stereotactic radiosurgery, delivery including collimator changes and custom plugging, fractionated treatment, all lesions, per session, second through fifth sessions, maximum five sessions per course of treatment Reviews, Revisions, and Approvals Updated codes and disclaimers for HIX products Added low to intermediate risk localized prostate cancer to section I.as medically necessary. Updated background. Revised coding section, combining ICD 10 codes into applicable categories. References reviewed and updated. Revised wording in I.A from “in patients who are not surgical candidates” to “as an alternative to surgery”; Added to section I. Indications for SBRT: Pancreatic cancer and high risk prostate cancer, when specific criteria are met; Added to section II- indication for SRS: Refractory epileptic seizures in children, when criterion is met. Updated background information regarding NCCN recommendations on pancreatic cancer. Added note that ICD 10 code list may not be all inclusive. Added the following ICD-10 code/code ranges: C25.0 Revision Date 05/13 01/19 Approval Date 01/19 12/19 01/20 Page 6 of 11 CLINICAL POLICY Stereotactic Body Radiation Therapy Reviews, Revisions, and Approvals through C25.9, C78.89, G40.011 through G40.019, G40.111 through G40.119, G40.211 through G40.219, G40.311 through G40.319, G40.A11 through G40.A19, G40.B11 through G40.B19, G40.411 through G40.419, G40.803 through G40.804, G40.813 through G40.814, G40.823 through G40.824, and G40.911 through G40.919. Internal and external specialist review. Annual review of policy. References reviewed and updated. Added CPT- 61800. Replaced “member” with” member/enrollee” in all instances. Annual Review. In II.A., clarified that “one of the following” must be met. Removed “SBRT” from the note about proximity to cranial nerves in II.F. “Experimental/investigational” verbiage replaced in criteria III. with descriptive language. Changed "Last Review Date" in the header to "Date of Last Revision" and "Date" in revision log to "Revision Date". Reviewed by specialist. Annual review completed. Added I.F. “Recurrent malignant disease requiring palliation and/or as palliative treatment for liver-related symptoms”. “Inoperable spinal tumors” added as criteria I.I. Added I.K. “Extracranial oligometastatic disease: 1. One to three metastatic lesions involving the lungs, liver or bone; 2. Primary tumor is breast, colorectal, melanoma, non-small cell lung, prostate, renal cell, or sarcoma; 3. Primary tumor is controlled; 4. No prior history of metastatic disease”. Background updated and minor rewording with no clinical significance. ICD-10 Code table removed. References reviewed and updated. Reviewed by external specialist. Added note to policy to refer to MC.CP.MP.22 for Medicare criteria. Added “non-Medicare” to health plans in Policy/Criteria I., II. and III. Revision Date Approval Date 12/20 01/21 01/22 01/22 01/23 01/23 08/23