LCD: Proton Beam Therapy L31617

Contractor Information

Contractor Name
Wisconsin Physicians Service Insurance Corporation		 Contractor Number
00951, 00952, 00953, 00954, 52280, 05101, 05201, 05301, 05401, 05102, 05202, 05302, 05402		 Contractor Type
Carrier - FI - MAC

LCD Information

Document Information
LCD ID Number
L31617

LCD Title
Proton Beam Therapy

Contractor's Determination Number
RAD-040

AMA CPT/ADA CDT Copyright Statement
CPT codes, descriptions and other data only are copyright 2011 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology, (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental Association. © 2002, 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply.

Primary Geographic Jurisdiction


Oversight Region

Original Determination Effective Date
For services performed on or after 03/17/2012

Original Determination Ending Date


Revision Effective Date
For services performed on or after 03/17/2012

Revision Ending Date


CMS National Coverage Policy
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.

National Coverage Determination (NCD) for Routine Costs in Clinical Trials (310.1)

Indications and Limitations of Coverage and/or Medical Necessity
In conventional external beam radiation therapy (EBRT), the targeted tissue usually receives 95-100% of the intended dose. A major limitation of EBRT is that in some situations, because critical normal tissues cannot be completely protected from the radiation, a curative dose cannot be used.

Proton Beam radiotherapy is a form of conformal external beam radiation treatment. Protons are positively charged atomic particles and have similar biological effects as conventional x-ray beams, but have very different energy disposition or physics profiles. Conventional x-ray beams give off the most energy a short distance below the skin surface (entrance dose) and continue to deposit some dose throughout the path of the beam even beyond the target (exit dose). Conventional EBRT delivers radiation to a more broad range of diseased and normal tissues with targeted tissue receiving approximately 95-100% of the intended dose but a larger volume of normal/unintended tissue receiving a significantly higher dose of radiation that is approximately 20-60% of the dose. In short, there is a higher integral dose to the normal tissue with conventional external beam therapy. In contrast, proton particles deposit a smaller amount of radiation energy as they enter the body (lower entrance dose), culminating in an intensity dose peak, also called the Bragg Peak. There is no further energy deposition beyond the Bragg peak (no exit dose). The depth of the peak can be controlled by the amount of the proton's energy. While the unaltered Bragg Peak is measured in millimeters, it can be spread out to encompass whole or partial volumes of a tumor. Like other conformal radiation modalities, proton beams can be precisely delivered to the tumor volume without harming surrounding healthy tissue or critical organs. Proton beams typically 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. Proton beam therapy will typically have a significantly lower integral dose (dose to the whole body of the patient) compared to conventional x-ray therapy. Intensity-modulated radiation therapy (IMRT), gives integral radiation dose to normal tissues compared to proton beam therapy. Due to reduction in integral with protons the most important benefits can be expected for pediatric patients.

Proton therapy is of particular value in those tumors located close to vital organs (or organs at risk) where a small local overdose can cause fatal complications such as tumors close to the spinal cord. Irregular shaped lesions near critical structures are well suited for protons. In general, proton beam radiotherapy is not indicated for cancers that are widely disseminated, such as leukemias or malignancies with hematogenous metastases or as a short term palliative procedure. Proton beam therapy is also not indicated in the treatment of very radiosensitive tumors such as lymphomas or germ cell neoplasms. 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. Due to the reduction in integral dose with protons, the most important benefits can be expected for pediatric patients. In adults, proton beam therapy should be reserved to treat patients that have clinically apparent disease (by exam or medical imaging).

Protons provide a dosimetric advantage compared to x-rays for many tumor treatment sites. In general, x-rays give 1.5 to 3 times more integral dose outside the target volume than protons, primarily in the low and medium dose range. There is no benefit to irradiating normal tissues outside of the intended treatment volume, and treatment to larger volumes of normal tissues is associated with increased toxicity, including an increased risk of second malignancies.

Stereotactic techniques are sometimes used with proton beam therapy especially for skull based, uveal tract tumors and others.

The proton beam therapy system must be FDA approved.

Indications:

Proton beam therapy will be considered medically reasonable and necessary for the following conditions:
Group 1

1. Unresectable benign or malignant central nervous system tumors to include but not limited to primary and variant forms of astrocytoma, glioblastoma, medulloblastoma, acoustic neuroma, craniopharyngioma, benign and atypical meningiomas, pineal gland tumors, and arteriovenous malformations.
2. Intraocular melanomas
3. Pituitary neoplasms
4. Chordomas and chondrosarcomas
5. Advanced staged and unresectable malignant lesions of the head and neck. (Cover only if there was prior radiotherapy treatment in the same site.)
6. Malignant lesions of the Para nasal sinus, and other accessory sinuses
7. Unresectable retroperitoneal sarcoma
8. Solid tumors in children
In addition to the criteria in Group I, Proton Beam Therapy indications must demonstrate that:

  • The Dose Volume Histogram (DVH) one or more critical structures or organs protected by the use of Proton Beam Therapy;

  • The dose to control or treat the tumor cannot be delivered without exceeding the tolerance of the normal tissue;

  • There is documented clinical rationale that doses generally thought to be above the level otherwise attainable with other radiation methods might improve control rates; or

  • There is documented clinical rationale that higher levels of precision associated with Proton Beam Therapy compared to other radiation treatments are clinically necessary.


For the treatment of primary lesions, the intent of treatment must be curative. For the treatment of metastatic lesions, there must be

a. the expectation of a long-term benefit (Greater Than 2 Year of life expectancy) that could not have been attained with conventional therapy

b. the expectation of a complete eradication or improved duration of control 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.

  • 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 (IRB) review when appropriate and patient informed consent are also expected.



Group 2
This section defines conditions that are still under investigation and would be covered when part of a clinical trial, registry or both. (See details in coding section)

1. Unresectable lung cancers and upper abdominal/peri-diaphragmatic cancers (Requires Image Guidance required for organ motion).
2. Advanced stage, unresectable pelvic tumors including those with peri-aortic nodes or malignant lesions of the cervix
3. Technically un-resectable left breast tumors
4. Unresectable pancreatic and adrenal tumors (Require Image Guidance required for organ motion.)
5. Skin cancer with macroscopic perineural/cranial nerve invasion of skull base
6. Unresectable Malignant lesions of the liver, biliary tract, anal canal and rectum
7. Prostate Cancer, Non-Metastatic.

Prostate Cancer
There is as yet no good comparative data to determine whether or not Proton Beam Therapy for prostate cancer is superior, inferior, or equivalent to external beam radiation, IMRT, or brachytherapy in terms of safety or efficacy. For Group II tumors: Unresectable is defined by surgical consultation.

The prostate cancer should be locally contained and not be an advanced prostate cancer (i.e. T3 or T4 where the tumor has spread through the capsule or has invaded seminal vesicles or other structures) and not any N disease (i.e. no spread to lymph nodes or there has been spread to the pelvic lymph nodes). Note: spread into pelvic lymph nodes is considered metastatic disease.

Coverage and payments of Proton Beam Therapy for prostate cancer will require:
a. Physician documentation of patient selection criteria (stage and other factors as represented in the NCCN guidelines);
b. Documentation and verification that the patient was informed of the range of therapy choices, including risks and benefits.

Other factors considered favorable for coverage include enrollment of the patient in an appropriate clinical registry for planned assessment and publication, clinical trials.

In addition to the criteria in Group II, Proton Beam Therapy indication must demonstrate that:

  • T and N Staging must be documented by CT or MRI scan findings.

  • The term "unresectable" is determined by surgical consultation.

  • The Dose Volume Histogram (DVH) illustrates one or more critical structures or organs protected by the use of Proton Beam Therapy;

  • The dose to control or treat the tumor cannot be delivered without exceeding the tolerance of the normal tissue;

  • There is documented clinical rationale that doses generally thought to be above the level otherwise attainable with other radiation methods might improve control rates; or

  • There is documented clinical rationale that higher levels of precision associated with Proton Beam Therapy compared to other radiation treatments are clinically necessary:



For the treatment of primary lesions, the intent of treatment must be curative

For the treatment of metastatic lesions, there must be

a. the expectation of a long-term benefit (Greater Than 2 Year of life expectancy) 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 (IMRT or 3-D radiation therapy). An IMRT or 3-D radiotherapy plan will need to be generated and compared to the Proton plan for target volume coverage and toxicity analysis.

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 (IRB) review when appropriate and patient informed consent are also expected.

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. (See Coding Guidelines).


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.


0333 Radiology - Therapeutic and/or Chemotherapy Administration - Radiation Therapy

CPT/HCPCS Codes

77520PROTON TREATMENT DELIVERY; SIMPLE, WITHOUT COMPENSATION
77522PROTON TREATMENT DELIVERY; SIMPLE, WITH COMPENSATION
77523PROTON TREATMENT DELIVERY; INTERMEDIATE
77525PROTON TREATMENT DELIVERY; COMPLEX

ICD-9 Codes that Support Medical Necessity

Note: ICD-9 codes must be coded to the highest level of specificity

Group 1
158.0 - 158.9MALIGNANT NEOPLASM OF RETROPERITONEUM - MALIGNANT NEOPLASM OF PERITONEUM UNSPECIFIED
160.0 - 160.9MALIGNANT NEOPLASM OF NASAL CAVITIES - MALIGNANT NEOPLASM OF ACCESSORY SINUS UNSPECIFIED
170.0 - 170.9MALIGNANT NEOPLASM OF BONES OF SKULL AND FACE EXCEPT MANDIBLE - MALIGNANT NEOPLASM OF BONE AND ARTICULAR CARTILAGE SITE UNSPECIFIED
171.0 - 171.9MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE OF HEAD FACE AND NECK - MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE SITE UNSPECIFIED
189.0MALIGNANT NEOPLASM OF KIDNEY EXCEPT PELVIS
190.0 - 190.9MALIGNANT NEOPLASM OF EYEBALL EXCEPT CONJUNCTIVA CORNEA RETINA AND CHOROID - MALIGNANT NEOPLASM OF EYE PART UNSPECIFIED
191.0 - 191.9MALIGNANT NEOPLASM OF CEREBRUM EXCEPT LOBES AND VENTRICLES - MALIGNANT NEOPLASM OF BRAIN UNSPECIFIED SITE
192.0 - 192.9MALIGNANT NEOPLASM OF CRANIAL NERVES - MALIGNANT NEOPLASM OF NERVOUS SYSTEM PART UNSPECIFIED
194.0 - 194.9MALIGNANT NEOPLASM OF ADRENAL GLAND - MALIGNANT NEOPLASM OF ENDOCRINE GLAND SITE UNSPECIFIED
195.0 - 195.8MALIGNANT NEOPLASM OF HEAD FACE AND NECK - MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES
198.3SECONDARY MALIGNANT NEOPLASM OF BRAIN AND SPINAL CORD
213.0 - 213.9BENIGN NEOPLASM OF BONES OF SKULL AND FACE - BENIGN NEOPLASM OF BONE AND ARTICULAR CARTILAGE SITE UNSPECIFIED
225.0BENIGN NEOPLASM OF BRAIN
225.9BENIGN NEOPLASM OF NERVOUS SYSTEM PART UNSPECIFIED
227.3BENIGN NEOPLASM OF PITUITARY GLAND AND CRANIOPHARYNGEAL DUCT
227.4BENIGN NEOPLASM OF PINEAL GLAND
237.0NEOPLASM OF UNCERTAIN BEHAVIOR OF PITUITARY GLAND AND CRANIOPHARYNGEAL DUCT
237.1NEOPLASM OF UNCERTAIN BEHAVIOR OF PINEAL GLAND
237.2NEOPLASM OF UNCERTAIN BEHAVIOR OF ADRENAL GLAND
237.5NEOPLASM OF UNCERTAIN BEHAVIOR OF BRAIN AND SPINAL CORD
237.6NEOPLASM OF UNCERTAIN BEHAVIOR OF MENINGES
336.9UNSPECIFIED DISEASE OF SPINAL CORD
747.81CONGENITAL ANOMALIES OF CEREBROVASCULAR SYSTEM
Group 2
153.0 - 153.9MALIGNANT NEOPLASM OF HEPATIC FLEXURE - MALIGNANT NEOPLASM OF COLON UNSPECIFIED SITE
154.0 - 154.8MALIGNANT NEOPLASM OF RECTOSIGMOID JUNCTION - MALIGNANT NEOPLASM OF OTHER SITES OF RECTUM RECTOSIGMOID JUNCTION AND ANUS
155.0 - 155.2MALIGNANT NEOPLASM OF LIVER PRIMARY - MALIGNANT NEOPLASM OF LIVER NOT SPECIFIED AS PRIMARY OR SECONDARY
156.0 - 156.9MALIGNANT NEOPLASM OF GALLBLADDER - MALIGNANT NEOPLASM OF BILIARY TRACT PART UNSPECIFIED SITE
157.0 - 157.9MALIGNANT NEOPLASM OF HEAD OF PANCREAS - MALIGNANT NEOPLASM OF PANCREAS PART UNSPECIFIED
159.0 - 159.9MALIGNANT NEOPLASM OF INTESTINAL TRACT PART UNSPECIFIED - MALIGNANT NEOPLASM OF ILL-DEFINED SITES WITHIN THE DIGESTIVE ORGANS AND PERITONEUM
162.2 - 162.8MALIGNANT NEOPLASM OF MAIN BRONCHUS - MALIGNANT NEOPLASM OF OTHER PARTS OF BRONCHUS OR LUNG
179 - 184.9MALIGNANT NEOPLASM OF UTERUS-PART UNS - MALIGNANT NEOPLASM OF FEMALE GENITAL ORGAN SITE UNSPECIFIED
185MALIGNANT NEOPLASM OF PROSTATE
197.7MALIGNANT NEOPLASM OF LIVER SECONDARY
198.4SECONDARY MALIGNANT NEOPLASM OF OTHER PARTS OF NERVOUS SYSTEM

Diagnoses that Support Medical Necessity

ICD-9 Codes that DO NOT Support Medical Necessity
Any diagnosis not listed above.

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

Diagnoses that DO NOT Support Medical Necessity
Diagnoses not listed in section ICD-9 Codes that Support Medical Necessity

General Information

Documentations Requirements
1. All documentation must be maintained in the patient's medical record and available to the contractor upon request.
2. Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, dates of service(s)). The record must include the physician or non-physician practitioner responsible for and providing the care of the patient.
3. The submitted medical record should support the use of the selected ICD-9-CM code(s). The submitted CPT/HCPCS code should describe the service performed.
4. Each claim must be submitted with ICD-9-CM codes that reflect the condition of the patient, and indicate the reason(s) for which the service was performed. Claims submitted without ICD-9-CM codes will be returned.
5. Documentation in the patient medical record must support:

The reasonable and necessary requirements are outlined under the coverage and limitations sections of this LCD and must be available to the contractor for review upon request.

Documentation must include the planned course of therapy, type and delivery of treatment, level of clinical management involved and ongoing documentation of any changes in the course of treatment, and DHV as noted in the covered indications section


Appendices

Utilization Guidelines

Sources of Information and Basis for Decision
Other Contractor Policies: Highmark, First Coast

Agency for Healthcare Research and Quality; AHRQ; Particle Beam Radiation Therapies for Cancer Publication No. 09-EHC019-EF; Revised November 2009, www.ahrq.gov

Agency for Healthcare Research and Quality; Comparative effectiveness of therapies for clinically localized prostate cancer; Feb 2008, www.ahrq.gov

ASTRO/ACR Guide to Radiation Oncology 2010

Baumert BG, et al; A comparison of dose distributions of proton and photon beams in stereotactic conformal radiotherapy of brain lesions; International Journal of Radiation Oncology, Biology, Physics, (2001)49(5): 1439-49.

Chen JCT, Girvigian M.R.; Stereotactic radiosurgery; instrumentation and theoretical aspects-part 1; Perm Jour; 2005 Fall 9(4) 23-26.

Cozzi L, Fogliata A, Lomax A.; A Treatment Planning Comparison of 3D Conformal Therapy, Photon Therapy, and Proton Therapy for Treatment of Advanced Head and Neck Tumors; Radiotherapy and Oncology.2001; 61: 287-297.

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

MacDonald, SM, et al; Proton beam radiation therapy; Cancer Invest.; 2006,Mar;24(2):199-208.

Noel G, et al.; Combination of Photon and Proton Rad Therapy for Chordomas and Chondrosarcomas of the Skull Base; Int J Radiation Onc, Bio, Physics 2001; 51(2):392-398.

Merchant TE, Hua CH, Shukla H, et al. Proton versus photon radiotherapy for common pediatric brain tumors: comparison of models of dose characteristics and their relationship to cognitive function. Pediatr Blood Cancer. 2008; 51(1):110-117.

Noel G, et al; 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.

Nguyen, Paul l. et al; Proton-Beam vs Intensity-Modulated Radiation Therapy Which Is Best for Treating Prostate Cancer?; ONCOLOGY. Vol. 22 No. 7; 06/01/2008

Olsen D.R et al;. Proton therapy - a systematic review of clinical effectiveness; Radiother Oncol 2007; 83:123-132.

Paganetti, Harald and Bortfeld, Thomas; Proton Beam Radiotherapy - The State of the Art;
Massachusetts General Hospital, Boston, MA, USA

Petit, Joshua H. et al; Proton Stereotactic Radiotherapy for Persistent Adrenocorticotropin-Producing Adenomas; J Clin Endocrinol Metab, February 2008, 93(2):393-399 jcem.endojournals.org

Slater, Jerry; Clinical Applications of Proton Irradiation Treatment at Loma Linda University: Review of a Fifteen Year Experience; Technology in Cancer Research and Treatment ISSN 1533-0346. Vol. 5 No. 2 April 2006

Smith RP; Modern radiation treatment planning and delivery from Röntgen to real time; Hematol Oncol Clin North Am.; 2006 Feb;20; (1):45-62.

U.S. Food and Drug Administration (FDA) 510(k) summary; Hitachi's PROBEAT k053280; Mar 9, 2006; www.fda.gov

U.S. Food and Drug Administration (FDA) 510(k) summary; Optivus proton beam therapy system k992414; July 21,2000; www.fda.gov.


Advisory Committee Meeting Notes
Meeting Date:
Wisconsin 01/28/2011
Illinois 01/26/2011
Michigan 02/02/2011
Minnesota 01/20/2011
J5 - Iowa, Kansas,
Missouri, Nebraska 02/10/2011

This policy does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the MAC contractor this policy was developed in cooperation with advisory groups which include representatives from various specialties, and adapted for the purpose of converting to MAC jurisdiction.

Start Date of Comment Period
02/10/2011
End Date of Comment Period
03/27/2011
Start Date of Notice Period
10/01/2011
Revision History Number
X
Revision History Explanation
03/05/2012 Typographical correction

Reason for Change
Typographical Correction

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Page Last Updated: Monday, 02-Apr-2012 15:52:30 CDT