*** This policy was implemented in the absence of National Coverage Determinations (NCD) or Local Coverage Determinations (LCD) coverage criteria. This policy applies to all Blue Medicare HMO, Blue Medicare PPO, Healthy Blue + MedicareSM (HMO-POS D-SNP), Blue Medicare Rx members, and members of any third-party Medicare plans supported by Blue Cross NC through administrative or operational services. ***

Description of Procedure

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 malignancies. Proton beam therapy requires specialized equipment in the form of accelerators (cyclotrons, synchrotrons, synchrocyclotrons, or linear accelerators) that can generate a beam of proton particles. Proton beam therapy contrasts with conventional electromagnetic (i.e., photon) radiation therapy 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 to surrounding normal tissues is minimized. The theoretical advantages of protons and other charged-particle beams may improve outcomes when the following conditions apply:

• Conventional treatment modalities do not provide adequate local tumor control;
• Evidence shows that local tumor response depends on the dose of radiation delivered; and
• Delivery of adequate radiation doses to the tumor is limited by the proximity of vital radiosensitive tissues or structures.

The use of proton radiation therapy has been investigated in two general categories of tumors/abnormalities. However, advances in photon-based radiation therapy (RT) such as 3-D conformal RT, intensity-modulated RT (IMRT), and stereotactic body radiotherapy (SBRT) allow improved targeting of conventional therapy.

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 radiation therapy are impossible. These tumors/lesions include uveal melanomas, chordomas, and chondrosarcomas at the base of the skull and along the axial skeleton.
2. Tumors at risk of local recurrence despite maximal doses of conventional radiation 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 are typically used.

Policy Statement

Coverage will be provided for Proton Beam Therapy when it is determined to be medically necessary when the medical criteria and guidelines shown below are met.

Benefit Application

Please refer to the member’s individual Evidence of Coverage (EOC) for benefit determination.  Coverage will be approved according to the EOC limitations if the criteria are met.

Coverage decisions will be made in accordance with:

• The Centers for Medicare & Medicaid Services (CMS) national coverage decisions;
• General coverage guidelines included in original Medicare manuals unless superseded by operational policy letters or regulations; and
• Written coverage decisions of local Medicare carriers and intermediaries with jurisdiction for claims in the geographic area in which services are covered.

Benefit payments are subject to contractual obligations of the Plan.  If there is a conflict between the general policy guidelines contained in the Medical Coverage Policy Manual and the terms of the member’s particular Evidence of Coverage (E.O.C.), the E.O.C. always governs the determination of benefits.

Indications for Coverage

Proton Beam therapy may be considered medically necessary for the curative treatment of the following clinical indications:

1. Primary ocular tumors, including intraocular/uveal melanoma
2. Post – operative therapy (with or without conventional high energy X-rays) in patients who have undergone biopsy or a partial resection of chordoma or low grade (I or II) chondrosarcoma of the basisphenoid region skull-based chordoma or chondrosarcoma) or cervical spine. Patients eligible for this treatment have residual localized tumors without evidence of metastasis. 
3. Stage IA/IB/IIA/Non-Bulky IIB Seminoma
4. Malignancies requiring CSI (craniospinal irradiation)
5. Reirradiation where other established radiation techniques are documented to exceed published (i.e., Quantec) normal tissue dose constraints
6. Cancers of nasopharynx, nasal cavities, paranasal sinuses, and other accessory sinuses
7. Cancers of the oropharynx

When Coverage Will Not Be Approved

Proton Beam therapy will be denied under for all other indications not addressed above under, “When Proton Beam Therapy” is covered, including but not limited to, use of proton beam therapy for:

• Clinically localized prostate cancer;
• Non-small -cell lung cancer (NSCLC) at any stage or for recurrence;

BCBSNC considers the use of IMRT, or other technologies appropriate to safely treat all other indications, and therefore, proton beam therapy is not cost effective when compared to alternatives, such as IMRT. For the exceptional situations in which a provider feels that is not the case, a detailed explanation is required, and Blue Cross NC will consider whether proton beam therapy will be covered on such exceptional circumstances.

Billing/Coding/Physician Documentation Information

This policy may apply to the following codes.  Inclusion of a code in the section does not guarantee reimbursement.

Applicable codes: 77520, 77522, 77523, 77525

The Plan may request medical records for determination of medical necessity.  When medical records are requested, letters of support and/or explanation are often useful but are not sufficient documentation unless all specific information needed to make a medical necessity determination is included.

Special Notes

For individuals who have uveal melanoma(s) who receive proton beam therapy, the evidence includes RCTs and systematic reviews. Relevant outcomes are overall survival, disease-free survival, change in disease status, and treatment-related morbidity. Systematic reviews, including a 1996 TEC Assessment and a 2013 review of randomized and non-randomized studies, concluded that the technology is at least as effective as alternative therapies for treating uveal melanomas and is better at preserving vision. The evidence is sufficient to determine qualitatively that technology results in a meaningful improvement in the net health outcome.

For individuals who have skull-based tumor(s) (i.e., cervical chordoma and chondrosarcoma) who receive proton beam therapy, the evidence includes observational studies and systematic reviews. Relevant outcomes are overall survival, disease-free survival, change in disease status, and treatment-related morbidity. A 2016 systematic review of observational studies found 5-year survival rates after proton beam therapy ranging from 67% to 94%. The evidence is sufficient to determine qualitatively that technology results in a meaningful improvement in the net health outcome.

For individuals who have localized prostate cancer who receive proton beam therapy, the evidence includes 2 RCTs and systematic reviews. Relevant outcomes are overall survival, disease-free survival, change in disease status, and treatment-related morbidity. A 2010 TEC Assessment addressed the use of PBT for prostate cancer and concluded that it has not yet been established whether PBT improves outcomes in any setting for clinically localized prostate cancer. The TEC Assessment included 2 RCTs, only 1 of which included a comparison group of patients who did not receive proton-beam therapy. No data on the use of PBT for prostate cancer has been published since 2010 that would alter the conclusions of the TEC Assessment. The evidence is insufficient to determine the effects of technology on health outcomes.

For individuals who have non-small-cell lung cancer who receive proton beam therapy, the evidence includes case series and systematic reviews. Relevant outcomes are overall survival, disease-free survival, change in disease status, and treatment-related morbidity. A 2010 TEC Assessment included 8 case series and concluded that the evidence is insufficient to permit conclusions about proton beam therapy for any stage of non-small cell lung cancer. No subsequent randomized or non-randomized comparative studies have been published. The evidence is insufficient to determine the effects of technology on health outcomes.

For individuals who have head and neck tumors other than skull-based who receive proton beam therapy, the evidence includes case series and a systematic review. Relevant outcomes are overall survival, disease-free survival, change in disease status, and treatment-related morbidity. The evidence is insufficient to determine the effects of technology on health outcomes. The systematic review noted that the studies for proton beam therapy were heterogenous in terms of type of particle and delivery techniques, and that there are no head-to-head trials comparing proton beam therapy to other treatments.

References

1. Local Coverage Determination (LCD) Proton Beam Therapy (L35075) effective date 10/01/2015 accessed on 4/22/2026 via LCD - Proton Beam Therapy (L35075)
   https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=35075&ver=34
2. Local Coverage Determination (LCD) Proton Beam Radiotherapy (L33937) effective date 10/01/2015 accessed on 04/22/2026 via LCD - Proton Beam Radiotherapy (L33937)
   https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=33937&ver=18
3. LCD Reference Article Billing and Coding: Proton Beam Therapy (A56827) effective date 11/07/2019 accessed on 04/22/2026 via Article - Billing and Coding: Proton Beam Therapy (A56827)
   https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=56827&ver=16
4. LCD Reference Article Billing and Coding: Proton Beam Radiotherapy (A57669) effective date 10/03/2018 accessed on 04/22/2026 via Article - Billing and Coding: Proton Beam Radiotherapy (A57669)
   https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=57669&ver=10
5. Blue Cross Blue Shield Blue Care Network Michigan Medical Policy - Charged Particle (Proton or Helium Ion) Radiotherapy For Neoplastic Conditions effective date 3/1/26 accessed on 04/23/26
6. Humana Medical Policy – Proton Beam, Neutron Beam, and Carbon Ion Radiation Therapy effective date 02/02/2026accessed on 04/22/2026
7. WellCare North Carolina Cente Corporation Clinical Policy – Proton and Neutron Beam Therapies effective date 03/2014 accessed on 04/22/2026
8. Blue Cross NC Commercial Medical Policy – Proton Beam Therapy effective date 03/01/1996 accessed on 04/22/2026 via Proton Beam Therapy | Providers | Blue Cross NC
   https://www.bluecrossnc.com/providers/policies-guidelines-codes/commercial/radiology/updates/proton-beam-therapy

Policy Implementation/Update Information:

Revision Date: April 22, 2026 – Newly created policy due to absence of NCD, LCD, LCA in Palmetto Jurisdiction. (AR)

Approval Dates:

Medical Coverage Policy Committee: May 21, 2026

Physician Advisory Group Committee: May 11, 2026