L30366-LCD

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Local Coverage Determination (LCD) for Stereotactic Radiosurgery (SRS) and Stereotactic Body Radiation Therapy (SBRT) (L30366)

Contractor Information

Contractor Name

First Coast Service Options, Inc. opens in new window

Contractor Number 09102

Contractor Type MAC - Part B

LCD Information

Document Information

LCD ID Number L30366

LCD Title

Stereotactic Radiosurgery (SRS) and Stereotactic Body Radiation Therapy (SBRT)

Contractor's Determination Number 77371

Primary Geographic Jurisdiction opens in new window Florida

Oversight Region Region IV

AMA CPT/ADA CDT Copyright Statement

Applicable FARS/DFARS Apply to Government Use. 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. The Code on Dental Procedures and Nomenclature (Code) is published in Current Dental Terminology (CDT). Copyright © American Dental Association. All rights reserved. CDT and CDT-2010 are trademarks of the American Dental Association.

Original Determination Effective Date

For services performed on or after 10/05/2009 Original Determination Ending Date

Revision Effective Date

For services performed on or after 01/01/2011 Revision Ending Date

CMS National Coverage Policy

Language quoted from CMS National Coverage Determination (NCDs) and coverage provisions in interpretive manuals are italicized throughout the Local Coverage Determination (LCD). NCDs and coverage provisions in interpretive manuals are not subject to the LCD Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See §1869(f)(1)(A)(i) of the Social Security Act.

Unless otherwise specified, italicized text represent quotation from one or more of the following CMS sources: CMS Manual System, Pub. 100-03, Medicare National Coverage Determination (NCD) Manual, Chapter 1, Part 2,

§160.4.

Indications and Limitations of Coverage and/or Medical Necessity

Stereotactic Radiosurgery (SRS) and Stereotactic Body Radiation Therapy (SBRT) are noninvasive means of administering high-dose radiotherapy to discreet tumor foci in cranial or extracranial locations respectively. The two forms of treatment share certain overarching principles, namely, the use of image guidance and related treatment delivery technology for escalating the radiation dose to the tumor with as little radiation dose to the surrounding tissue as possible. Both methods are achieved with a “sterotactic” technique, implying that fiducial reference markers serve to align the treatment machine so that an internal lesion is targeted accurately; however, notable differences in clinical applications emerge given the vastly different anatomic and clinical consideration between cranial and extracranial target lesions.

This LCD recognizes these two distinct treatment approaches and is specific to treatment delivery:

1. Stereotactic Radiosurgery (SRS) and Stereotactic Body Radiation Therapy (SBRT): cranial lesions are distinct disciplines that utilize externally generated high dose ionizing radiation in certain cases to inactivate or eradicate (a) defined target (s) in the head without the need to make an incision. The target is defined by high

-resolution stereotactic imaging. The process of care involves the radiation oncologist and/or neurosurgeon and physicist. For a subset of tumors involving the skull base, the multidisciplinary team may also include a head and neck surgeon with training in stereotactic radiosurgery. SRS/SBRT are typically performed in a single session, using a rigidly attached stereotactic guiding device, other immobilization technology and/or a stereotactic image- guidance system, but can be performed in a limited number of sessions, up to a maximum of five.

Technologies that are used to perform SRS/SBRT include linear accelerators, particle beam accelerators, and multi-source Cobalt 60 units. In order to enhance precision, various devices may incorporate robotics and real time imaging.

To qualify for SRS/SBRT a high dose should be delivered in a single fraction or in 2-5 fractions. 500 cGy (5 Gray) in a single dose is considered the minimum dose as a ‘high dose’ for SRS. A more typical dose would be 1400- 2500 cGy (14-25 Gray) if given in one fraction.

In general, SRS/SBRT is not indicated for cancers that are widely disseminated, unless evidence can be provided to justify the expectation of a meaningful clinical benefit, as well as evidence of a dosimetric advantage for SRS/SBRT over other forms of radiation therapy.

Indications

FCSO Medicare will consider SRS/SBRT: cranial lesions medically reasonable and necessary for the following indications:

• Primary central nervous system malignancies, generally under 5 cm and as a boost treatment for larger cranial, base of skull, or spinal lesions that have been treated initially with external beam radiation therapy or surgery (i.e., grade III and IV gliomas, oligodendrogliomas, sarcomas, chondrosarcomas, chordomas, and nasopharyngeal or paranasal sinus malignancies).

• Primary and secondary tumors involving the brain or spine parenchyma, meninges/dura, or immediately adjacent boney structures.

• Benign brain tumors and spinal tumors such as cranial meningiomas, acoustic neuromas, other schwanomas, pituitary adenomas, pineal cytomas, craniopharyngiomas, glomus tumors, and hemangiolastomas.

• Cranial arteriovenous malformations and hemangiomas.

• Trigeminal neuralgia not responsive to medical management.

• Metastatic brain lesions, generally limited in number, with stable systemic disease, Karnofsky Performance Status 40 or greater (or expected to return to 70 or greater with treatment), and otherwise reasonable survival expectations or an Eastern Cooperative Oncology Group (ECOG): Performance Status of 3 or less (or expected to return to 2 or less with treatment).

• Relapse in a previously irradiated cranial or spinal field where the additional stereotactic precision is required to avoid unacceptable vital tissue radiation.

• Other cranial non-neoplastic conditions for which it has been proven effective, e.g., movement disorders such as Parkinson’s disease, essential tremor and other disabling tremor that are refractory to conventional therapy, such as severe, sustained trigeminal neuralgia not responsive to other modalities.

2. Stereotactic Body Radiation Therapy (SBRT) is an emerging treatment method that utilizes externally generated high dose ionizing radiation in certain cases to inactivate or eradicate (a) defined target (s) within the body. The target is defined by high-resolution stereotactic imaging. In addition to the radiation oncologist and/or neurosurgeon and physicist, the process may involve input from other surgical specialists. SBRT performed using immobilization technology and a stereotactic image-guidance system can be performed in a limited number of sessions, up to a maximum of five.

To qualify for SBRT, a high dose should be delivered in a single fraction or in 2-5 fractions. 500 cGy (5 Gray) is considered the minimum dose as a ‘high dose’ for SBRT. A more typical dose would be 1400-2500 cGY (14-25 Gray) if given in one fraction.

Indications

FCSO Medicare will consider SBRT medically reasonable and necessary for certain conditions 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 SBRT 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 with the exception of lesions within the pancreas or liver.

5. For the treatment of metastatic lesions, there must be:

- the expectation of a long-term benefit (> 6 months) 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 SBRT over other forms of radiation therapy.

6. The patient’s record demonstrates why SBRT 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, conventional radiation therapy, IMRT or 3-dimensional conformal radiation. Dosimetric evidence of reduced normal tissue toxicity and/or improved tumor control must be maintained.

FCSO Medicare will consider SBRT medically reasonable and necessary only if the above criteria are met as specified for the following conditions:

Spinal Lesions

• Previously untreated spinal metastases or spinal metastases that have recurred after conventional radiotherapy and clinical reasons preclude a surgical approach.

Lung Cancer

• Early stage Bronchogenic Carcinoma -treatment of early stage bronchogenic carcinomas in medically unresectable patients

• Pulmonary Metastatic Disease -patient has limited pulmonary metastatic disease and no active disease elsewhere in the body,

• Patients that might otherwise be candidates for resection, but precluded by co-existing medical condition(s) or technically difficult lesion location.

• Recurrent Disease- Very selected cases for long-term palliative use

Liver Cancer

• Primary hepatocellular carcinoma- Patients who are not surgical candidates.

• Secondary metastases to the liver, not amenable to surgical resection. Generally limited to less than 4 simultaneous lesions.

Pancreatic Cancer

• Palliative intent and selected cases for curative intent or unresectable.

Kidney and Adrenal Gland

• Primary and metastatic tumors

Limitations:

1. Treatment for anything other than a severe symptom or serious threat to life or critical functions, not responsive or reasonably amenable to another therapy.

2. Treatment unlikely to result in functional improvement or clinically meaningful disease stabilization, not otherwise achievable.

3. In general, stereotactic radiosurgery is not indicated for cancers that are widespread with cerebral or extra- cranial metastases. The intent of treatment should be curative, except in cases where radiosurgery will provide the best palliation, resulting in significant quality of life.

4. Patients with poor performance status (Karnofsky Performance Status < 40), - see Karnofsky Performance Status below* or Eastern Cooperative Oncology Group (ECOG) Performance Status > 3.

5. A claim for stereotacticcingulotomy as a means of psychotherapy, considered investigational, per Medicare National Coverage Determinations (NCD) Manual, Publication 100-03, Chapter 1, Part 2, Section 160.4.

6. Lesions of bone, breast, uterus, ovary and other internal organs not listed above are not covered for primary definitive SBRT as literature does not support an outcome advantage over other conventional radiation modalities

7. Claims for primary prostate cancer will be developed (documentation requested) for medical review and payment considered on an individual case by case basis (refer to the ‘Documentation Requirements’ section of this LCD).

*Karnofsky Performance Scale (Perez and Brady, p 225) 100 Normal; no complaints, no evidence of disease

90 Able to carry on normal activity; minor signs or symptoms of disease 80 Normal activity with effort; some signs or symptoms of disease

70 Cares for self; unable to carry on normal activity or to do active work 60 Requires occasional assistance but is able to care for most needs

50 Requires considerable assistance and frequent medical care 40 Disabled; requires special care and assistance

30 Severely disabled; hospitalization is indicated although death not imminent

20 Very sick; hospitalization necessary; active supportive treatment is necessary 10 Moribund, fatal processes progressing rapidly

0 Dead

Eastern Cooperative Oncology Group: Performance Scale and corresponding Karnofsky Rating (Cancer Medicine 5th ed)

0 Fully active, able to carry on all pre disease activities without restriction Karnofsky 100)

1 Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, for example, light housework/office work (Karnofsky 80-90)

2 Ambulatory and capable of all self care but unable to carry out any work activities; up and about more than 50% of waking hours (Karnofsky-70)

3 Capable of limited self-care, confined to bed or chair 50% or more of waking hours (Karnofsky 40-50)

4 Completely disabled; cannot carry on any self-care; totally confined to bed or chair (Karnofsky 30 or less) 5 Dead

Coding Information

Bill Type Codes:

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.

999x Not Applicable

Revenue Codes:

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

99999 Not Applicable

CPT/HCPCS Codes

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

G0339 IMAGE-GUIDED ROBOTIC LINEAR ACCELERATOR-BASED STEREOTACTIC RADIOSURGERY, COMPLETE COURSE OF THERAPY IN ONE SESSION OR FIRST SESSION OF FRACTIONATED TREATMENT

G0340

Printed on 9/29/2012. Page 5 of 10

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

ICD-9 Codes that Support Medical Necessity

These are the only covered ICD-9-CM codes that support medical necessity under this LCD for procedure codes 77371, 77372, 77373, G0339 and G0340 for SRS:

147.0 - 147.9 opens in new window

160.1 - 160.9 opens in new window

MALIGNANT NEOPLASM OF SUPERIOR WALL OF NASOPHARYNX - MALIGNANT NEOPLASM OF NASOPHARYNX UNSPECIFIED SITE

MALIGNANT NEOPLASM OF AUDITORY TUBE MIDDLE EAR AND MASTOID AIR CELLS - MALIGNANT NEOPLASM OF ACCESSORY SINUS UNSPECIFIED

170.2 MALIGNANT NEOPLASM OF VERTEBRAL COLUMN EXCLUDING SACRUM AND COCCYX

190.0 - 190.9 opens in new window

191.0 - 191.9 opens in new window

MALIGNANT NEOPLASM OF EYEBALL EXCEPT CONJUNCTIVA CORNEA RETINA AND CHOROID - MALIGNANT NEOPLASM OF EYE PART UNSPECIFIED

MALIGNANT NEOPLASM OF CEREBRUM EXCEPT LOBES AND VENTRICLES - MALIGNANT NEOPLASM OF BRAIN UNSPECIFIED SITE

192.1 MALIGNANT NEOPLASM OF CRANIAL NERVES

192.2 MALIGNANT NEOPLASM OF CEREBRAL MENINGES

192.3 MALIGNANT NEOPLASM OF SPINAL MENINGES

194.3 MALIGNANT NEOPLASM OF PITUITARY GLAND AND CRANIOPHARYNGEAL DUCT

194.4 MALIGNANT NEOPLASM OF PINEAL GLAND

194.6 MALIGNANT NEOPLASM OF AORTIC BODY AND OTHER PARAGANGLIA

198.3 SECONDARY MALIGNANT NEOPLASM OF BRAIN AND SPINAL CORD

198.4 * SECONDARY MALIGNANT NEOPLASM OF OTHER PARTS OF NERVOUS SYSTEM

198.89* SECONDARY MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES

213.2 BENIGN NEOPLASM OF VERTEBRAL COLUMN EXCLUDING SACRUM AND COCCYX

225.1 BENIGN NEOPLASM OF BRAIN

225.2 BENIGN NEOPLASM OF CRANIAL NERVES

225.3 BENIGN NEOPLASM OF CEREBRAL MENINGES

225.4 BENIGN NEOPLASM OF SPINAL CORD

225.5 BENIGN NEOPLASM OF SPINAL MENINGES

227.3 BENIGN NEOPLASM OF PITUITARY GLAND AND CRANIOPHARYNGEAL DUCT

227.4 BENIGN NEOPLASM OF PINEAL GLAND

227.6 BENIGN NEOPLASM OF AORTIC BODY AND OTHER PARAGANGLIA

228.02 HEMANGIOMA OF INTRACRANIAL STRUCTURES

234.8* CARCINOMA IN SITU OF OTHER SPECIFIED SITES

237.1 NEOPLASM OF UNCERTAIN BEHAVIOR OF PITUITARY GLAND AND CRANIOPHARYNGEAL DUCT

237.2 NEOPLASM OF UNCERTAIN BEHAVIOR OF PINEAL GLAND

237.3 NEOPLASM OF UNCERTAIN BEHAVIOR OF PARAGANGLIA

237.5 * NEOPLASM OF UNCERTAIN BEHAVIOR OF BRAIN AND SPINAL CORD

237.6 * NEOPLASM OF UNCERTAIN BEHAVIOR OF MENINGES

239.6 * NEOPLASM OF UNSPECIFIED NATURE OF BRAIN

239.7 * NEOPLASM OF UNSPECIFIED NATURE OF ENDOCRINE GLANDS AND OTHER PARTS OF NERVOUS SYSTEM

255.3 OTHER CORTICOADRENAL OVERACTIVITY

332.0 PARALYSIS AGITANS

333.1* ESSENTIAL AND OTHER SPECIFIED FORMS OF TREMOR

350.1 TRIGEMINAL NEURALGIA

350.8 OTHER SPECIFIED TRIGEMINAL NERVE DISORDERS

351.1 GENICULATE GANGLIONITIS

351.8 OTHER FACIAL NERVE DISORDERS

351.9 FACIAL NERVE DISORDER UNSPECIFIED

352.1 * DISORDERS OF OLFACTORY (1ST) NERVE

352.2 * GLOSSOPHARYNGEAL NEURALGIA

352.3 * OTHER DISORDERS OF GLOSSOPHARYNGEAL (9TH) NERVE

352.4 * DISORDERS OF PNEUMOGASTRIC (10TH) NERVE

352.5 * DISORDERS OF ACCESSORY (11TH) NERVE

352.6 * DISORDERS OF HYPOGLOSSAL (12TH) NERVE

352.7 * MULTIPLE CRANIAL NERVE PALSIES

352.9* UNSPECIFIED DISORDER OF CRANIAL NERVES

747.81 * CONGENITAL ANOMALIES OF CEREBROVASCULAR SYSTEM

747.82 SPINAL VESSEL ANOLMALY

*ICD-9-CM 333.1 code is limited to the patient who cannot be controlled with medication, has major systemic disease or coagulopathy, and who is unwilling or unsuited for open surgery.

* ICD-9-CM codes 198.4, 198.89, 234.8, 237.5, 237.6, 239.6, 239.7, 333.1, 352.0, 352.1, 352.2, 352.3, 352.4,

352.5, 352.6, 352.9 and 747.81 are all limited to use for lesions occurring either above the neck or in the spine.

These are the only covered ICD-9-CM codes that support medical necessity under this LCD for procedure codes 77373, G0339 and G0340 for SBRT:

147.0 - 147.9 opens in new MALIGNANT NEOPLASM OF SUPERIOR WALL OF NASOPHARYNX - MALIGNANT

window

NEOPLASM OF NASOPHARYNX UNSPECIFIED SITE

155.0 - 155.2 opens in new MALIGNANT NEOPLASM OF LIVER PRIMARY - MALIGNANT NEOPLASM OF LIVER NOT

window

SPECIFIED AS PRIMARY OR SECONDARY

157.0 - 157.9 opens in new MALIGNANT NEOPLASM OF HEAD OF PANCREAS - MALIGNANT NEOPLASM OF

window

PANCREAS PART UNSPECIFIED

162.0 - 162.9 opens in new MALIGNANT NEOPLASM OF TRACHEA - MALIGNANT NEOPLASM OF BRONCHUS AND

window

LUNG UNSPECIFIED

189.1 MALIGNANT NEOPLASM OF KIDNEY EXCEPT PELVIS

189.2 MALIGNANT NEOPLASM OF RENAL PELVIS

194.0 MALIGNANT NEOPLASM OF ADRENAL GLAND

197.0 SECONDARY MALIGNANT NEOPLASM OF LUNG

197.7 MALIGNANT NEOPLASM OF LIVER SECONDARY

197.8 * SECONDARY MALIGNANT NEOPLASM OF OTHER DIGESTIVE ORGANS AND SPLEEN

198.0 SECONDARY MALIGNANT NEOPLASM OF KIDNEY

198.3 SECONDARY MALIGNANT NEOPLASM OF BRAIN AND SPINAL CORD

198.4 * SECONDARY MALIGNANT NEOPLASM OF OTHER PARTS OF NERVOUS SYSTEM

198.89* SECONDARY MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES

227.6 BENIGN NEOPLASM OF AORTIC BODY AND OTHER PARAGANGLIA

234.8 CARCINOMA IN SITU OF OTHER SPECIFIED SITES

237.3 NEOPLASM OF UNCERTAIN BEHAVIOR OF PARAGANGLIA

239.7* NEOPLASM OF UNSPECIFIED NATURE OF ENDOCRINE GLANDS AND OTHER PARTS OF NERVOUS SYSTEM

* ICD-9-CM 197.8 is limited to secondary malignant neoplasms of pancreas and may not be used for other diagnoses.

* ICD-9-CM codes 198.4, 198.89, and 239.7 are all limited to use for lesions occurring either above the neck or in the spine.

Diagnoses that Support Medical Necessity N/A

ICD-9 Codes that DO NOT Support Medical Necessity XX000 Not Applicable

ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation

Diagnoses that DO NOT Support Medical Necessity N/A

General Information

Documentations Requirements

The patient's record must support the necessity and frequency of treatment. Medical records should include not only the standard history and physical but also the patient's functional status and a description of current performance status (Karnofsky Performance Status or Eastern Cooperative Oncology Group Performance Scale). See Karnofsky Performance Scale and Eastern Cooperative Oncology Group Performance Scale listed under the Indications and Limitations of Coverage and/or Medical Necessity section of the LCD above.

The patient’s record demonstrates why SBRT 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 conventional radiation therapy, IMRT or 3-dimensional conformal radiation.

Dosimetric evidence of reduced normal tissue toxicity and/or improved tumor control must be included.

Documentation should include the date and the current treatment dose.

• A radiation oncologist and/or a neurosurgeon, as clinically indicated, must evaluate the clinical aspects of the treatment, and document and sign this evaluation as well as the resulting management decisions.

• A radiation oncologist and/or a neurosurgeon, and medical physicist must evaluate the technical aspects of the treatment and document and sign this evaluation as well as the resulting treatment management decisions.

When the documentation does not meet the criteria for the service rendered or the documentation does not establish the medical necessity for the services, such services will be denied as not reasonable and necessary under Section 1862 (a) of the Social Security Act.

For prostate cancer, claims will be developed (documentation requested) for medical review and payment considered on an individual case by case basis. Documentation should include the information noted above, as well as the following information:

• Patient selection (stage and other favorable factors).

• Verification that the patient was informed of the range of therapy choices, including the risks and benefits of SBRT (especially the risk of long term toxicities).

• The rationale for SBRT as a treatment choice for the patient.

Appendices

Utilization Guidelines It is expected that these services would be performed as indicated by current medical literature and/or standards of practice. When services are performed in excess of established parameters, they

may be subject to review for medical necessity.

Sources of Information and Basis for Decision

American Association of Neurological Surgeons, the Congress of Neurological Surgeons, and the American Society of Therapeutic Radiology and Oncology) (2007). AANS/CNS/ASTRO Definition of Stereotactic Radiosurgery.

Retrieved on January 8, 2007 via Internet: http://www.aans.org/library/article. Definitions

American Cancer Society. Principles of Surgical Oncology Surgical Therapy Cancer Medicine 5th ed. Retrieved on September 9, 2008 via Internet at http://ww.ncbi.nlm.nih.gov/books.

American College of Radiology (ACR) and the American Society for Therapeutic Radiology and Oncology (ASTRO). (2006). Practice Guideline for the performance of stereotactic radiosurgery. Retrieved January 8, 2007 via Internet: http://www.acr.org.

American College of Radiology (ACR) and the American Society for Therapeutic Radiology and Oncology (ASTRO) (2006). Practice guideline for radiation oncology. Retrieved January 8, 2007 via Internet: http://www.acr.org.

American Society Therapeutic Radiation Oncology, Emerging technology Committee. (2008) Stereotactic Body Radiation Therapy for primary management of early stage, low intermediate risk for prostate cancer. Retrieved via Internet: http://www.astro.org. (Supports non-coverage of Prostate therapy)

American Society Therapeutic Radiation Oncology. The ASTRO/ACR Guide to Radiation Oncology Coding (2007).

Beitler, J., Makara, D., Silverman, P., etal., Definitive, high-dose-per-fraction, conformal, stereotactic external radiation for renal cell carcinoma. Am J Clin Oncol 27 (6): 646-8. Kidney

Blue Cross and Blue Shield Association (2006). Stereotactic Radiosurgery and Stereotactic Radiotherapy Medical Policy.

Bucholz, R.D., Gagnon, G.J., Gerszten, P.C., Kresl, J.J., Levendag, P.C., Mould, R.F., & Schulz, R.A., (eds.) (2005). Robotic Radiosurery 1 (33) Cyberknife Society Press.

Crowley, R.W., Pouratian, N., Sheehan, J. (2006). Gamma knife surgery for glioblastoma multiforme. Neurosurgery Focus 20 (4): E17. Brain

Freeman, D., Friedland, J., Spellberg, D., Masterson, M.E., (2007). Cyberkinfe sterotactic radiosurery in the treatment of low risk prostate carcinoma. 6th annual cyberknife users meeting presentation of Naples Community Hospital experiences. Prostate

Fuss, M., Thomas, C., Stereotactic Body Radiation Therapy: An ablative treatment option to primary and secondary liver tumors. Ann Surgl Onc 11 (2): 130-138. Liver

Gerszten, P. C., Orhasoglu, C., Burton, S.A.,et. al., (yr). Cyberknife Frameless Stereotactic radiosurgery for spinal lesions. Clinical experience in 125 cases. J Neurosurg 55

(1): 89-98. Spine and sacrum

Gertzen, P.C., Burton, S.A., Ozhasoglu, C., Vogel, W.J., Welch, W.C., Barr, J., Friedland, D.M. (2005). Stereotactic radiosurgery for spinal metastases from renal cell carcinoma. J. Neurosurg: Spine 3: 288-295. Spine

Hof, H., Muenter, M., Oetzel, D., et al ,.(2007). Stereotactic single-dose radiotherapy (radiosurgery) of early stage non-small cell lung cancer (NSCLC) . Cancer lung

Kavanagh, B.D., Schefter, T.E., Cardenes, H., Stieber, V.W., Raben, D., Timmerman, R. D. , McCarter, M. D., Burri, S., Nedzi, L. A., Sawyer. T.E., Gaspar, L. E. (2006). Interim analysis of a prospective phase I/II trial of SBRT for liver metastases. Acta Oncologica 45: 848-855. Liver

Kavanagh, B.D., Timmerman, R.D. (2006). Stereotactic radiosurgery and sterotactic body radiation therapy: An overview of technical considerations and clinical applications. Hematology/Oncology Clinics of North America. 20

(1) introductory statement

IRSA Stereotactic Radiosurgery overview . Retrieved June 4, 2008 via Internet: http://www.irsa.org/radiosurgery.html

King, C., Lehmann, J. Adler, J., (2003). Cyberknife radiotherapy for localized prostate cancer: Rationale and technical feasibility. Technol Caner Res Treat 2 (1): 25-30.prostate

King,. C.R.. Brooks, J.D., Gill, H., Pawlicki, T., Cotrutz, C. Presti, J.C. (2008). (Article in press) Stereotactic body radiotherapy for localized prostate cancer: Interim results of a prospective phase II Clinical trial. Int. J. Radiation Oncology Biol. Phys. Prostate.

NCCN (2006). NCCN Clinical Practice Guidelines in Central Nervous System Cancers. Retrieved August 2008 via Internet: http://www.nccn.org

NCCN (2006). NCCN Clinical Practice Guidelines in Oncology (2007). Retrieved via Internet: http://www.nccn.org. Other Medicare Contractor’s LCDs

Perez, C.A., et al 2003. (Eds.). Principles and Practice of Radiation Oncology, 4th Ed., Philadelphia, Lippincott- Raven.

San Diego Cyberknife Center (2006). Cyberknife clinical indications. Retrieved on January 6, 2007 via Internet: http://www.sdcyberknife.com/indications.htm.

Souhami, L., Seiferheld, M.S., Brachman, D., Podgorsak, E.B., Werner-Wasik, M., Lustig, R., Schultz, C.J., Sause, W., Okunieff, P., Buckner, J., Zamorano, L., Mehta, M.P., Curran, W.J. (2004). Randomized comparison of stereotactic radiosurgery followed by conventional radiotherapy with carmustine to conventional radiotherapy with carmustine for patients with glioblastoma multiforme: Report of radiation therapy oncology group. Int J Radiation Oncology Biol Phys, 60 (3): 853-860.Brain

Sanghavi, S. Miranpuri, S., Chappel, R. et al. (2001). Radiosurgey for patients with brain metastases: a multi- institutional analysis, stratified by the RTOG recursive partitioning analysis method . Int J Radiat Oncol Biol Phys. 51 (2): 426-434. Intracranial

Tsao, M.N., Mehta, M. P., Whelan, T.J., Morris, D.E., Hayman, Flickinger, J.C., Mills, M. Rogers, C.L., Souhami, (2005). The American Society for therapeutic radiology and oncology (ASTRO) evidence based review of the role

of radiosurgery for malignant glioma. Int. J Radiation Oncology Biol Phys., 63: 47-55.Brain Advisory Committee Meeting Notes This Local Coverage Determination (LCD) does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the contractor, this LCD was developed in cooperation with advisory groups, which includes representatives from numerous societies.

Florida Carrier Advisory Meeting: June 20, 2009

Puerto Rico/Virgin Islands Carrier Advisory Meeting: June 25, 2009

Start Date of Comment Period 06/01/2009

End Date of Comment Period 07/15/2009

Start Date of Notice Period 08/20/2009

Revision History Number Original

Revision History Explanation Revision Number:Original Start Date of Comment Period:06/01/2009

Start Date of Notice Period:08/20/2009 Original Effective Date:10/05/2009

LCR B2009-089

August 2009 Update

11/21/2010 - For the following CPT/HCPCS codes either the short description and/or the long description was changed. Depending on which description is used in this LCD, there may not be any change in how the code displays in the document:

77371 descriptor was changed in Group 1 77372 descriptor was changed in Group 1

Reason for Change