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Charged-particle beams consisting of protons or helium ions are a type of particulate radiotherapy (RT). Treatment with charged-particle radiotherapy is proposed for a large number of indications, often for tumors that would benefit from the delivery of a high dose of radiation with limited scatter.
Charged-particle beams consisting of protons or helium ions are a type of particulate radiotherapy (RT). They contrast with conventional electromagnetic (i.e., photon) radiotherapy due to several unique properties, including minimal scatter as particulate beams pass through tissue, and deposition of ionizing energy at precise depths (i.e., the Bragg peak). Thus, radiation exposure of surrounding normal tissues is minimized. The theoretical advantages of protons and other charged-particle beams may improve outcomes when the following conditions apply:
The use of proton or helium ion radiotherapy has been investigated in two (2) general categories of tumors and abnormalities.
1. Tumors located near vital structures, such as intracranial lesions or lesions along the axial skeleton, such that complete surgical excision or adequate doses of conventional RT are impossible. These tumors/lesions include uveal melanomas, chordomas, and chondrosarcomas at the base of the skull along the axial skeleton.
2. Tumors associated with a high rate of local recurrence despite maximal doses of conventional RT. One tumor in this group is locally advanced prostate cancer (i.e., Stages C or D1 [without distant metastases], also classified as T3 or T4).
Advances in photon-based RT such as 3-dimensional conformal radiotherapy, intensity-modulated radiotherapy, and stereotactic body radiotherapy allow improved targeting of conventional therapy.
Proton beam therapy can be given with or without stereotactic techniques. Stereotactic approaches are frequently used for uveal tract and skull-based tumors. For stereotactic techniques, 3 to 5 fixed beams of protons or helium ions are used.
Also see the related medical policy, Stereotactic Radiosurgery (SRS) and Stereotactic Body Radiation Therapy (SBRT).
Charged-particle irradiation with proton or helium ion beams may be considered medically necessary in the following clinical situations:
Other applications of charged-particle irradiation with proton or helium ion beams are considered investigational. This includes, but is not limited to:
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Evidence is unavailable to define age parameters for the use of proton beam therapy in pediatric patients. Some studies using proton beam therapy in pediatric central nervous system tumors have mostly included patients younger than 3 years of age. However, experts cite the benefit of proton beam therapy in pediatric patients of all ages (<21 years of age).
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
7/27/2006: Approved by Medical Policy Advisory Committee (MPAC)
9/28/2006: Policy updated to include coverage of prostate cancer
8/21/2008: Policy updated to note that coverage of prostate cancer is not medically necessary. ICD-9 diagnosis185 removed
04/27/2010: Added “Charged-Particle” to the policy title. Added link to related policy to the description. Made minor wording change in the policy statement: “may be considered” changed to “is considered” in the second statement. Intent of policy statement unchanged. Added the definition of investigative service to the Policy Guidelines section.
12/30/2010: Policy statement revised to add "including but not limited to use of proton beam therapy for non-small-cell lung cancer (NSCLC) at any stage or for recurrence" as a specific indication to the investigational policy statement. Intent of policy statement unchanged.
12/01/2011: Policy reviewed; no changes.
05/07/2013: Policy statement revised to state that charged-particle irradiation with proton or helium ion beams may be considered medically necessary in the treatment of pediatric central nervous system tumors. The following were added as investigational applications: pediatric non-central nervous system tumors and tumors of the head and neck (other than skull-based chordoma or chondrosarcoma).
04/28/2014: Policy reviewed; description updated to include three advances in photon-based radiation therapy that allow improved targeting of conventional therapy. Policy statement unchanged.
08/21/2015: Code Reference section updated to add ICD-10 codes and to update CPT code descriptions.
09/11/2015: Code Reference section updated to add Investigational Codes table and ICD-10 procedure codes.
11/16/2015: Policy title changed from "Charged-Particle (Proton or Helium) Ion Radiation Therapy" to "Charged-Particle (Proton or Helium Ion) Radiotherapy." Policy description updated to change "radiation therapy" to "radiotherapy." Charged-particle irradiation for clinically localized prostate cancer changed from "not medically necessary" to "investigational. Removed not medically necessary policy statement from policy section. Investigative definition updated in policy guidelines.
05/25/2016: Policy number added.
08/22/2016: Policy title changed from "Charged-Particle (Proton or Helium Ion) Radiotherapy" to "Charged-Particle (Proton or Helium Ion) Radiotherapy for Neoplastic Conditions." Policy description updated. Investigational statement updated to include helium ion beams for consistency with first policy statement. Policy Guidelines updated regarding the use of proton beam therapy in pediatric patients.
Blue Cross Blue Shield Association policy # 8.01.10
This may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.