L29263-LCD

LCD/NCD Portal

Automated World Health

Local Coverage Determination (LCD) for Proton Beam Radiotherapy (L29263)

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 L29263

LCD Title

Proton Beam Radiotherapy

Contractor's Determination Number 77520

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 02/02/2009 Original Determination Ending Date

Revision Effective Date

For services performed on or after 10/01/2011 Revision Ending Date

CMS National Coverage Policy N/A

Indications and Limitations of Coverage and/or Medical Necessity

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.

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 metastic 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.

Proton beam therapy will be considered medically reasonable and necessary for the following conditions (Group

#1 of ICD-9-CM Codes that Support Medical Necessity): 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, First Coast Service Options, Inc. (FCSO) will consider proton beam therapy as medically reasonable and necessary for certain other conditions (i.e., Group #2 of ICD-9-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

a. the expectation of a long-term benefit (> 2y) that could not have been attained with conventional therapy

b. 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 radiation. 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 Medicare 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 (see Group #2 of the ICD-9 Codes that Support Medical Necessity).

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

Note: All other indications are not considered reasonable and necessary and will be denied.

If the patient cannot clearly meet the criteria for coverage but desires Proton beam radiotherapy based on a marketed theoretical advantage, the claim should be billed with the appropriate modifier appended to the treatment delivery code.

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.

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

Note: Other CPT/HCPCS codes may be appropriate (i.e., treatment planning, dosimetry, port films, etc.) 77520 PROTON TREATMENT DELIVERY; SIMPLE, WITHOUT COMPENSATION

77522 PROTON TREATMENT DELIVERY; SIMPLE, WITH COMPENSATION

77523 PROTON TREATMENT DELIVERY; INTERMEDIATE

77525 PROTON TREATMENT DELIVERY; COMPLEX

ICD-9 Codes that Support Medical Necessity Group #1 Listing

170.0 - 170.9 opens in MALIGNANT NEOPLASM OF BONES OF SKULL AND FACE EXCEPT MANDIBLE - MALIGNANT

new window

NEOPLASM OF BONE AND ARTICULAR CARTILAGE SITE UNSPECIFIED

171.0 - 171.9 opens in MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE OF HEAD FACE AND

new window

NECK - MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE SITE

UNSPECIFIED

189.0 MALIGNANT NEOPLASM OF KIDNEY EXCEPT PELVIS

190.0 - 190.9 opens in MALIGNANT NEOPLASM OF EYEBALL EXCEPT CONJUNCTIVA CORNEA RETINA AND

new window

CHOROID - MALIGNANT NEOPLASM OF EYE PART UNSPECIFIED

191.0 - 191.9 opens in MALIGNANT NEOPLASM OF CEREBRUM EXCEPT LOBES AND VENTRICLES - MALIGNANT

new window

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 CORD

192.4 MALIGNANT NEOPLASM OF SPINAL MENINGES

192.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF NERVOUS SYSTEM

194.3 MALIGNANT NEOPLASM OF PITUITARY GLAND AND CRANIOPHARYNGEAL DUCT

194.4 MALIGNANT NEOPLASM OF PINEAL GLAND

198.3 SECONDARY MALIGNANT NEOPLASM OF BRAIN AND SPINAL CORD

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

225.8 BENIGN NEOPLASM OF OTHER SPECIFIED SITES OF NERVOUS SYSTEM

227.3 BENIGN NEOPLASM OF PITUITARY GLAND AND CRANIOPHARYNGEAL DUCT

227.4 BENIGN NEOPLASM OF PINEAL GLAND

237.1 NEOPLASM OF UNCERTAIN BEHAVIOR OF PITUITARY GLAND AND CRANIOPHARYNGEAL DUCT

237.2 NEOPLASM OF UNCERTAIN BEHAVIOR OF PINEAL GLAND

237.5 NEOPLASM OF UNCERTAIN BEHAVIOR OF BRAIN AND SPINAL CORD

237.6 NEOPLASM OF UNCERTAIN BEHAVIOR OF MENINGES

747.81 CONGENITAL ANOMALIES OF CEREBROVASCULAR SYSTEM

Group #2 Listing

141.0 MALIGNANT NEOPLASM OF BASE OF TONGUE

142.1 MALIGNANT NEOPLASM OF PAROTID GLAND

142.2 MALIGNANT NEOPLASM OF SUBMANDIBULAR GLAND

142.3 MALIGNANT NEOPLASM OF SUBLINGUAL GLAND

143.1 MALIGNANT NEOPLASM OF UPPER GUM

143.2 MALIGNANT NEOPLASM OF LOWER GUM

144.0 - 144.9 opens in new window

145.0 - 145.9 opens in new window

146.0 - 146.9 opens in new window

147.0 - 147.9 opens in new window

148.0 - 148.9 opens in new window

MALIGNANT NEOPLASM OF ANTERIOR PORTION OF FLOOR OF MOUTH - MALIGNANT NEOPLASM OF FLOOR OF MOUTH PART UNSPECIFIED

MALIGNANT NEOPLASM OF CHEEK MUCOSA - MALIGNANT NEOPLASM OF MOUTH UNSPECIFIED

MALIGNANT NEOPLASM OF TONSIL - MALIGNANT NEOPLASM OF OROPHARYNX UNSPECIFIED SITE

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

MALIGNANT NEOPLASM OF POSTCRICOID REGION OF HYPOPHARYNX - MALIGNANT NEOPLASM OF HYPOPHARYNX UNSPECIFIED SITE

149.1 MALIGNANT NEOPLASM OF PHARYNX UNSPECIFIED

149.2 MALIGNANT NEOPLASM OF WALDEYER'S RING

154.0 - 154.8 opens in new window

MALIGNANT NEOPLASM OF RECTOSIGMOID JUNCTION - MALIGNANT NEOPLASM OF OTHER SITES OF RECTUM RECTOSIGMOID JUNCTION AND ANUS

155.0 - 155.2 opens in new window

157.0 - 157.9 opens in new window

MALIGNANT NEOPLASM OF LIVER PRIMARY - MALIGNANT NEOPLASM OF LIVER NOT SPECIFIED AS PRIMARY OR SECONDARY

MALIGNANT NEOPLASM OF HEAD OF PANCREAS - MALIGNANT NEOPLASM OF PANCREAS PART UNSPECIFIED

158.0 MALIGNANT NEOPLASM OF RETROPERITONEUM

160.0 - 160.9 opens in new window

161.0 - 161.9 opens in new window

162.0 - 162.9 opens in new window

MALIGNANT NEOPLASM OF NASAL CAVITIES - MALIGNANT NEOPLASM OF ACCESSORY SINUS UNSPECIFIED

MALIGNANT NEOPLASM OF GLOTTIS - MALIGNANT NEOPLASM OF LARYNX UNSPECIFIED

MALIGNANT NEOPLASM OF TRACHEA - MALIGNANT NEOPLASM OF BRONCHUS AND LUNG UNSPECIFIED

164.1 MALIGNANT NEOPLASM OF THYMUS

164.2 MALIGNANT NEOPLASM OF HEART

164.3 MALIGNANT NEOPLASM OF ANTERIOR MEDIASTINUM

164.4 MALIGNANT NEOPLASM OF POSTERIOR MEDIASTINUM

173.00 - 173.99 opens in new window

UNSPECIFIED MALIGNANT NEOPLASM OF SKIN OF LIP - OTHER SPECIFIED MALIGNANT NEOPLASM OF SKIN, SITE UNSPECIFIED

174.1 MALIGNANT NEOPLASM OF NIPPLE AND AREOLA OF FEMALE BREAST

174.2 MALIGNANT NEOPLASM OF CENTRAL PORTION OF FEMALE BREAST

174.3 MALIGNANT NEOPLASM OF UPPER-INNER QUADRANT OF FEMALE BREAST

174.4 MALIGNANT NEOPLASM OF LOWER-INNER QUADRANT OF FEMALE BREAST

174.5 MALIGNANT NEOPLASM OF UPPER-OUTER QUADRANT OF FEMALE BREAST

174.6 MALIGNANT NEOPLASM OF LOWER-OUTER QUADRANT OF FEMALE BREAST

174.7 MALIGNANT NEOPLASM OF AXILLARY TAIL OF FEMALE BREAST

180.1 MALIGNANT NEOPLASM OF ENDOCERVIX

180.2 MALIGNANT NEOPLASM OF EXOCERVIX

180.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF CERVIX

183.0 MALIGNANT NEOPLASM OF OVARY

184.0 MALIGNANT NEOPLASM OF VAGINA

185 MALIGNANT NEOPLASM OF PROSTATE

188.0 - 188.9 opens in new window

MALIGNANT NEOPLASM OF TRIGONE OF URINARY BLADDER - MALIGNANT NEOPLASM OF BLADDER PART UNSPECIFIED

193 MALIGNANT NEOPLASM OF THYROID GLAND

194.1 MALIGNANT NEOPLASM OF PARATHYROID GLAND

195.1 MALIGNANT NEOPLASM OF THORAX

195.2 MALIGNANT NEOPLASM OF ABDOMEN

195.3 MALIGNANT NEOPLASM OF PELVIS

197.0 SECONDARY MALIGNANT NEOPLASM OF LUNG

197.7 MALIGNANT NEOPLASM OF LIVER SECONDARY

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

Documentation must support that the services were performed, including the condition requiring proton beam therapy and why this technology was medically necessary as opposed to conventional radiation therapy. The medical record must support that all requirements listed under Indications and Limitations of Coverage and/or Medical Necessity have been met. The medical record should contain all of the necessary information to process a claim for these services including supporting information about the indications for a particular procedure.

Appendices

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

Sources of Information and Basis for Decision

American Association of Clinical Endocrinologists Medical Guidelines for Clinical Practice. Role of radiation therapy. Retrieved from the web on 11/15/2005 at www.guideline.gov.

American College of Radiation Oncology (ACRO), Practice Management Guide; Proton Therapy in the United States (2004).

Barker, FG, Butler, WE, Lyons, S, Cascio, E, Ogilvy, CS, Loeffler, JS, Chapman, PH (2003). Dose-volume prediction of radiation-related complications after proton beam radiosurgery for cerebral arteriovenous malformations. Journal of Neurosurgery, 99(2): 222-3; discussion 223-4.

Baumert BG, Lomax AJ, Miltchev V, Davis JB (2001). A comparison of dose distributions of proton and photon beams in stereotactic conformal radiotherapy of brain lesions. International Journal of Radiation Oncology, Biology, Physics, 49(5): 1439-49.

Bush DA, Hillebrand DJ, Slater JM, Slater JD. High-Dose Proton Radiotherapy of Hepatocellular Carcioma: Preliminary Results of a Phase II Trial. Gastroenterology 2005:128:S189-S193

Cozzi L, Fogliata A, Lomax A, Bolsi A. A treatment planning comparison of 3D conformal therapy, intensity modulated photon therapy, and proton therapy for treatment of advanced head and neck tumours. Radiotherapy and Oncology 61: 287-297, 2001.

Hug EB, Nevinny-Stickel M, Fuss M, Miller DW, Schaefer RA, Slater JD. Conformal Proton Radiation Treatment for Retroperitoneal Neuroblastoma: Introduction of a Novel Technique. Medical and Pediatric Oncology 37: 36-41, 2001.

Kawashima M, Furuse J, Nishio T, Konishi M, Ishii H, Kinoshita T, Nagase M, Nihei K, Ogino T. Phase II Study of Radiotherapy Employing Proton Beam for Hepatocellular Carcinoma. J Clin. Oncol., Vol. 23(9)1839-1846, 2005

Kirsch DG, Tarbell NJ (2004). New technologies in radiation therapy for pediatric brain tumors: the rational for proton radiation therapy. Pediatric Blood Cancer, 42(5): 461-4.

National Cancer Institute, Fact Sheet [On-line]. Retrieved from the web on 12/14/05 and available at: www.cancer.gove/cancertopics/factsheet/Therapy/radiation.

Noel G, Habrand JL, Mammar H, Pontvert D, Haie-Meder C, Hasboun D, Moisson P, Ferrand R, Beaudre A, Boisserie G, Gaboriaud G, Mazai A, Kerody K, Schlienger M, Mazeron JJ. Combination of Photon and Proton Radiation Therapy for Chordomas and Chondrosarcomas of the Skull Base: The Centre de Protontherapie D’Orsay Experience. Int. J. Radiat. Oncol. Biol. Phys., 51(2)392-398, 2001.

Rundle P, Singh AD, Rennie I (2006). Proton beam therapy for iris melanoma: a review of 15 cases. Eye, Retrieved from PubMed at www.ncbi.nlm.nih.gov on March 31, 2006.

Slater JD. Clinical Applications of Proton Radiation Treatment at Loma Linda University: Review of a Fifteen-year Experience. Technology in Cancer Research and Treatment, Vol. 5(2) 81-89, April 2006.

Weber DC, Rutz HP, Pedroni ES, Bolsi A, Timmermann B, Verwey J, Lomax AJ, Goitein G. Results of Spot- Scanning Proton Radiation Therapy for Chordoma and Chondrosarcoma of the Skull Base: The Paul Scherrer Institut Experience. Int. J. Radiat. Oncol. Biol. Phys., Vol. 63(2)401-409, 2005.

Weber DC, Chan AW, Bussiere MR, Harsh GR, Ancukiewicz M, Barker FG, Thornton AT, Martuza RL, Nadol JB, Chapman PH, Loeffler JS. Proton Beam Radiosurgery for Vestibular Schwannoma: Tumor Control and Cranial Nerve Toxicity. Neurosurgery 53: 577-588, 2003.

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.

Start Date of Comment Period

End Date of Comment Period

Start Date of Notice Period 12/04/2008

Revision History Number 1

Revision History Explanation Revision Number:1 Start Date of Comment Period:N/A

Start Date of Notice Period:10/01/2011 Revised Effective Date: 10/01/2011

LCR B2011-101

September 2011 Connection

Explanation of Revision: Annual 2012 ICD-9-CM Update. Changed diagnosis code range 173.0-173.9 to diagnosis code range 173.00-173.99. The effective date of this revision is based on date of service.

Revision Number:Original

Start Date of Comment Period:N/A Start Date of Notice Period:12/04/2008 Revised Effective Date:02/02/2009

LCR B2009-

December 2008 Bulletin

This LCD consolidates and replaces all previous policies and publications on this subject by the carrier predecessors of First Coast Service Options, Inc. (Triple S and FCSO).

For Florida (00590) this LCD (L29263) replaces LCD L23163 as the policy in notice. This document (L29263) is effective on 02/02/2009.

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:

77520 descriptor was changed in Group 1 77522 descriptor was changed in Group 1 77523 descriptor was changed in Group 1 77525 descriptor was changed in Group 1

08/27/2011 - This policy was updated by the ICD-9 2011-2012 Annual Update.

Reason for Change