Date Printed: February 9, 2010: 06:19 AM

Private Property of Blue Cross and Blue Shield of Florida.
This medical policy (medical coverage guideline) is Copyright 2010, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2010 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association.

04-77260-18

Original Effective Date: 06/15/02

Reviewed: 03/25/09

Revised: 04/15/09

Subject: Proton Beam Therapy

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

DESCRIPTION:

Proton beams are charged particle beams used as an alternative to conventional x-rays, gamma-rays, and other types of photon irradiation in the treatment of malignant disease. Their use requires specialized equipment in the form of accelerators (cyclotrons, synchrotrons, synchrocyclotrons, or linear accelerators) that can generate a beam of proton particles. Accurate localization of the malignancy by using tomographic scanning (with x-ray and/or magnetic resonance imaging), and precise and reproducible positioning (relative to the beam) and immobilization of the patient during both tomographic scanning and treatment is also required. This type of radiation allows for minimal scatter as particulate beams pass through tissue and disposes ionizing energy at precise depths (i.e., the Bragg peak), thereby minimizing tissue damage around the area being treated.

Proton beam therapy is a type of particle beam radiation therapy. Protons deposit their energy over a very small area, which is called the Bragg peak. The Bragg peak can be used to target high doses of proton beam therapy to a tumor while doing less damage to normal tissues in front of and behind the tumor. In addition, proton beam therapy can be administered while minimizing the dose delivered to surrounding healthy tissue. Proton beams theoretically enable patients to tolerate higher total doses of radiation than can be tolerated with photon (x-rays) radiation. Proton therapy may be used alone or in combination with photon radiation therapy. Like conventional radiation therapy, proton therapy treatments may take anywhere from a few days or up to several weeks, depending on the tumor. Proton beam therapy is only available at a few facilities in the United States.

Proton beam therapy has been found to be useful in the treatment of tumors that are localized and have not spread to distant areas of the body and are not amenable to surgical excision or other conventional forms of radiation treatment. This includes tumors that are in close proximity to vital structures, which make surgery or conventional radiation therapy difficult or impossible. Proton beam therapy is not suitable for all tumor types, but may be beneficial in treating tumors of the eye, head and neck, cancers that are difficult or dangerous to treat with surgery, and for tumors where conventional radiotherapy would damage surrounding tissue to an unacceptable level (e.g., optical nerve, spinal cord, central nervous system, head, neck, and prostate). Because proton beam therapy can be used to precisely focus radiation on specific areas with little exposure to adjacent tissues, proton beam may be useful for treatment of tumors located near radio-sensitive structures, where even low doses of radiation could cause significant damage. In addition, proton beam therapy has been used to limit treatment related morbidity in children with tumors in or near the brain and where the need to avoid secondary tumors is important due to their potentially long life span after radiation treatment when they may develop radiation-induced malignancies.

POSITION STATEMENT:

The intent of proton beam therapy is curative, with an expectation of a long-term benefit (greater than 2 years).

Proton beam therapy meets the definition of medical necessity for the following:

All other indications not listed above are considered experimental or investigational, as there is insufficient evidence to support conclusions regarding the effect of proton beam radiotherapy on health outcomes.

BILLING/CODING INFORMATION:

The following codes may be used to report proton beam delivery: Other CPT/HCPCS codes may be reported (e.g., radiation treatment management, initial consultation, clinical treatment planning, simulation, medical radiation physics consultation, dosimetry, treatment devices).

CPT Coding:

HCPCS Coding:

ICD-9 Diagnoses Codes That Support Medical Necessity:

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

DEFINITIONS:

Acoustic Neuroma: A progressively enlarging, benign tumor, usually within the internal auditory canal arising from Schwann cells of the vestibular division of the eighth cranial nerve; the symptoms, which vary with the size and location of the tumor, may include hearing loss, headache, disturbances of balance and gait, facial numbness or pain, and tinnitus. It may be unilateral or bilateral (neurofibromatosis).

Astrocytoma: A tumor composed of astrocytes; it is the most common type of primary brain tumor and is also found throughout the central nervous system.

Benign: Not malignant. Not cancerous. Benign tumors may grow larger but do not spread to other parts of the body.

Craniopharyngioma: A tumor arising from cell rests derived from the hypophysial stalk or Rathke’s pouch, frequently associated with increased intracranial press, and showing calcium deposits in the capsule or in the tumor proper. Also called craniopharyngeal duct tumor, Rathke’s or Rathke’s pouch tumor, suprasellar cyst, and pituitary adamantinoma or ameloblastoma.

Clinical Treatment Planning: A complex process of services including interpretation of special testing, tumor localization, treatment volume determination, treatment time/dosage determination, choice of treatment modality, determination of number and size of treatment ports, selection of appropriate treatment devices, and other procedures. Clinical treatment planning is carried out by the physician.

Consultation Clinical Management: Preliminary (initial) consultation, evaluation of patient prior to decision to treat or full medical care.

Dosimetry: The calculation of the radiation dose distribution within an area of clinical interest.

Fractionation: The schedule of fractions of treatment as it is delivered. This is usually expressed as the number of fractions or treatment sessions delivered over a specific period of time.

Glioblastoma: A general term for malignant forms of astrocytoma. It occurs in the brain stem of children and occasionally in the spinal cord of an adult or child.

Immobilization Device: Any type of restraining device that conforms to the patient’s body conour to prevent motion during radiation treatment delivery.

Malignant: Cancerous. Malignant tumors can invade and destroy nearby tissue and spread to other parts of the body.

Medulloblastoma: A malignant, highly radiosensitive cerebellar tumor composed of undifferentiated neuroglial cells and usually considered a type of primitive neuroectodermal tumor. Most medulloblastomas occur in children and arise in or adjacent to the roof of the fourth ventricle.

Radiation Treatment Management: The ongoing medical management of a patient receiving a course of radiation treatment. Radiation treatment management is reported in units of five fractions or treatment sessions, regardless of the actual time period in which the services are furnished. The services need not be furnished on consecutive days. Multiple fractions representing two or more treatment sessions furnished on the same day may be counted separately as long as there has been a distinct break in therapy sessions, and the fractions are of the character usually furnished on different days. A set of five fractions (treatments) usually represents a week of treatment.

Simulation: Simulation is used to set the radiation therapy treatment portals to specific treatment volumes. This process is performed by a physician. Simulation is performed without actually delivering a treatment but utilizing all of the parameters of the treatment to be delivered. Visualization of the treatment area may be accomplished by means of a fluoroscope or x-ray film.

Tumor: A new growth of tissue in which the multiplication of cells is uncontrolled and progressive; also called neoplasm (benign or malignant).

RELATED GUIDELINES:

Stereotactic Radiosurgery (Intracranial), 02-77371-01
Stereotactic Body Radiotherapy, 02-77371-02

OTHER:

Other names used to report proton beam:

Charged Particle Radiation Therapy
Charged Particle Radiotherapy
Hadrontherapy
Helium Ion Radiation Therapy
Particle Beam Therapy
Proton Beam Radiotherapy

REFERENCES:

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 03/25/09.

GUIDELINE UPDATE INFORMATION:

Private Property of Blue Cross and Blue Shield of Florida.
This medical policy (medical coverage guideline) is Copyright 2010, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2010 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association.

Date Printed: February 9, 2010: 06:19 AM