CurrentUnitedHealthcarePolicy RADIOLOGY 045.8

Proton Beam Radiation Therapy

UnitedHealthcare policy RADIOLOGY 045.8 governing coverage rationale, applicable codes, definitions, clinical evidence, and documentation for proton beam radiation therapy for individuals 19 years and older (policy excludes pediatric automatic coverage). This part covers proven indications, criteria for exceptions, applicable CPT/HCPCS and ICD-10 codes, and clinical evidence summaries for listed indications.

Policy Summary

PayerUnitedHealthcare

PolicyProton Beam Radiation Therapy

Policy CodePolicy RADIOLOGY 045.8

Change TypeRevised coverage criteria and documentation requirements

Effective DateJun 1, 2025

Next Review Date

Key ActionTo request coverage for a non-listed diagnosis submit individualized comparisons of PBT, IMRT, and SBRT treatment plans and documentation that normal tissue sparing cannot be achieved with standard techniques.

POLICY UPDATE CHANGES

Medical Records Documentation Used for Review was updated to reflect the new plan-comparison requirement.

Clinical Evidence and References sections were updated to reflect current information and new citations.

Archived previous policy version RADIOLOGY 045.7.

4Listed Proven Indications

1Pediatric automatic coverage (<19 yrs)

Prostate cancer coverage per plan

9Disease sites discussed

multipleRandomized trials available

lowOverall evidence quality (many indications)

Coverage Summary

Policy RADIOLOGY 045.8 (Effective Date: June 1, 2025) governs coverage rationale, definitions, applicable codes, clinical evidence, and documentation requirements for Proton Beam Radiation Therapy (PBT/PBRT) for individuals 19 years of age and older. The policy notes that PBT is covered without further review for individuals younger than 19 years and that, for adults (≥19 years), coverage and medical necessity determinations generally require review and/or prior authorization per the member's benefit plan. For certain listed indications PBT is considered proven/medically necessary; for other adult indications, requests require individualized documentation and review (including treatment plan comparisons) to determine coverage under the member's benefit plan.

Policy-level facts

Policy NumberRADIOLOGY 045.8

Effective DateJune 1, 2025

Applies toIndividuals 19 years of age and older (automatic coverage <19 years)

Proven Indications Count4

Material Changetrue (coverage criteria revised to require individualized comparison of PBT, IMRT, and SBRT treatment plans)

Medical Necessity Criteria

General Age Application and Pediatric Exception

Policy age applicability and automatic coverage for children:

ALL of the following

This policy applies to individuals 19 years of age and older.
Proton beam radiation therapy (PBRT, PBT) is covered without further review for individuals younger than 19 years of age.

Proven / Medically Necessary Indications

Proton beam radiation therapy is proven and medically necessary for the following diagnoses/sites:

ONE of

Base of skull tumors (e.g., chordomas, chondrosarcomas, paranasal sinus, or nasopharyngeal tumors)

Provider Actions & Authorization

Prior Authorization

Prior review for adults

Because this policy applies to individuals 19 years and older, clinical review or prior authorization may be required by the member’s benefit plan to confirm that coverage criteria are met and that required medical records documentation is provided.

Prior Authorization

Prior authorization / plan comparison required

For diagnoses not listed as proven, prior authorization requires submission of an individualized comparison of treatment plans for the specific patient: PBT, IMRT, and SBRT. This plan-comparison must be part of the medical records used for review to evaluate potential benefit of PBT over photon-based options.

Coding

Proton treatment delivery CPT/HCPCS (referenced)CPT|HCPCS|mixed

77301	Intensity modulated radiotherapy plan, including dose-volume histograms for target and critical structure partial tolerance specifications.
77338	Multi-leaf collimator (MLC) device(s) for intensity modulated radiation therapy (IMRT), design and.
77385	Intensity modulated radiation treatment delivery (IMRT), includes guidance and tracking, when performed; simple.
77386	Intensity modulated radiation treatment delivery (IMRT), includes guidance and tracking; when performed; complex.
77387	Guidance for localization of target volume for delivery of radiation treatment; includes intrafraction tracking, when performed.
77520	Proton treatment delivery; simple, without compensation.
77523	Proton treatment delivery; intermediate.
77525	Proton treatment delivery; complex.
G6015	Intensity modulated treatment delivery, single or multiple fields/arcs, via narrow spatially and temporally modulated beams, binary, dynamic MLC, per treatment session.
G6016	Compensator-based beam modulation treatment delivery of inverse planned treatment using three or more high resolution compensator, per treatment session.

1–10 of 11

1/2

Referenced ICD-10 / Diagnosis codes relevant to covered indicationsICD-10

C11.0	Malignant neoplasm of superior wall of nasopharynx.
C11.1	Malignant neoplasm of posterior wall of nasopharynx.
C11.2	Malignant neoplasm of lateral wall of nasopharynx.
C11.3	Malignant neoplasm of anterior of nasopharynx wall.
C11.8	Malignant neoplasm of overlapping sites of nasopharynx.
C11.9	Malignant neoplasm of nasopharynx, unspecified.
C22.0	Liver cell carcinoma.
C30.0	Malignant neoplasm of nasal cavity.
C31.0	Malignant neoplasm of maxillary sinus.
C31.1	Malignant neoplasm of ethmoidal sinus.

1–10 of 61

1/7

No procedural or billing codes listed in this partmixed

No codes listed

Policy references and archived policymixed

No codes listed

Background & Evidence Summary

Proton beam therapy (PBT) uses positively charged protons to deliver radiation with a more confined dose distribution and minimal exit dose beyond tumor boundaries, enabling greater sparing of surrounding normal tissues compared with photon-based external beam radiation therapy. Evidence supporting PBT is stronger for select indications — for example, skull base chordomas/chondrosarcomas, ocular (uveal) melanomas, intracranial arteriovenous malformations (AVMs), and selected hepatocellular carcinomas (HCC) — where published series, systematic reviews, and meta-analyses report favorable local control and low severe toxicity rates. For many adult disease sites, however, comparative clinical benefits of PBT versus advanced photon techniques (e.g., IMRT, SBRT) have not been established; available data are often retrospective, heterogeneous, and of low to moderate quality, and randomized comparative evidence is limited or lacking.

Clinical Indications / Evidence Summary (narrative — conditional recommendations)

Summarized findings and guideline positions for PBT by disease site (evidence-based statements, conditional recommendations, and areas needing further RCTs):

Prostate cancer: Multiple single-institution and population-based studies report comparable biochemical control and mixed toxicity findings between PBT and IMRT; guidelines (AUA/ASTRO 2022) conditionally recommend PBT as an option but state it is not superior to other modalities; NCCN considers PBT a reasonable alternative when appropriate technology/expertise is available.

Age-related macular degeneration (AMD) and other ophthalmic indications: Evidence is limited and uncertain; systematic reviews and RCTs (older trials) show inconsistent visual outcomes and potential harms; AAO states insufficient data to demonstrate efficacy.

Revision History

2025-06-01material_revisionLatest

Coverage criteria for PBT were revised to allow consideration for diagnoses not listed as proven when an individualized comparison of treatment plans for PBT, IMRT, and SBRT for the specific individual is provided. Replaced prior wording requiring 'comparison of Definitive Therapy plans' with 'comparison of treatment plans for PBT, IMRT, and SBRT for the specific individual'; removed list of example unproven indications.

2025-06-01material_revisionLatest

Medical Records Documentation Used for Review was updated to reflect the new plan-comparison requirement; explicitly replaced older phrasing requiring 'evaluation includes a comparison of Definitive Therapy plans' with individualized treatment plan comparisons for the specific individual.

Policy Summary

PayerUnitedHealthcare

PolicyProton Beam Radiation Therapy

Policy CodePolicy RADIOLOGY 045.8

Change TypeRevised coverage criteria and documentation requirements

Effective DateJun 1, 2025

Next Review Date

On This Page

Definitive Therapy for hepatocellular carcinoma (HCC) (localized, unresectable) in the curative setting when documentation is provided that sparing of the surrounding normal tissue cannot be achieved with standard radiation therapy techniques, including intensity-modulated radiation therapy (IMRT), stereotactic body radiation therapy (SBRT), and selective internal radiation spheres, and transarterial therapy (for example, chemoembolization) is contraindicated or not technically feasible

Ocular tumors, including intraocular/uveal melanoma (includes the iris, ciliary body, and choroid)

Intracranial arteriovenous malformations (AVMs)

PBT and IMRT are proven and considered clinically equivalent for treating prostate cancer. Medical necessity will be determined based on the terms of the member's benefit plan.

Prostate Cancer

Statement regarding prostate cancer coverage:

PBT and IMRT are proven and considered clinically equivalent for treating prostate cancer.

Medical necessity will be determined based on the terms of the member's benefit plan.

Not Medically Necessary / Unproven Indications

PBT is unproven and not medically necessary for other indications not listed as proven; exceptions may be considered if criteria are met:

PBT is unproven and not medically necessary due to insufficient evidence of efficacy for treating all other indications.

Exception request requirements (both required)

Evaluation includes a comparison of treatment plans for PBT, IMRT, and SBRT for the specific individual.
Documentation is provided that sparing of the surrounding normal tissue cannot be achieved with standard radiation therapy techniques.

Revised Coverage Rationale for PBT

Coverage criteria for PBT were revised to allow consideration for diagnoses not explicitly listed as proven when ALL of the following are met:

Evaluation includes a comparison of treatment plans for PBT, IMRT, and SBRT for the specific individual

Replaced prior wording requiring 'comparison of Definitive Therapy plans'

Documentation demonstrates that PBT provides clinically meaningful benefit over IMRT and SBRT for the specific individual

Indication is not listed in the policy as proven for PBT but may be considered if individualized criteria met

Documentation Required

Documentation for HCC definitive therapy coverage

To qualify for definitive PBT coverage for localized, unresectable hepatocellular carcinoma (HCC), provide documentation that: sparing of the surrounding normal tissue cannot be achieved with standard radiation techniques (including IMRT, SBRT, and selective internal radiation spheres) AND transarterial therapy (for example, chemoembolization) is contraindicated or not technically feasible.

Documentation Required

Exception request requirements for non-listed diagnoses

For exception requests for diagnoses not listed as proven, submit both: 1) a comparison of treatment plans for PBT, IMRT, and SBRT tailored to the individual, and 2) documentation demonstrating that surrounding normal tissue cannot be spared with standard radiation techniques. Both elements are required for case-by-case consideration.

Documentation Required

Evidence-based rationale required for PBT

When requesting PBT for conditional or unproven indications, document the clinical rationale including details of patient anatomy and specific organs-at-risk (OAR) concerns, and cite relevant guideline positions (for example, NCCN, ASTRO, AUA/ASTRO) that support selecting PBT over photon therapy for the individual.

Prior Authorization

Prior authorization recommended for PBT in non-established indications

Given generally mixed and low-quality evidence across many adult tumor sites, payer-level prior authorization is implied or recommended for PBT to confirm indication, available alternatives, and facility capability—particularly when guidelines consider PBT a conditional option or the indication is unproven.

Documentation Required

Updated documentation requirements

Updated medical record requirements specify that providers must supply the Medical Records Documentation Used for Review per the policy, including individualized comparisons of treatment plans (PBT vs IMRT vs SBRT) and clinical justification that PBT offers clinically meaningful benefit for the specific patient.

Bladder cancer (muscle-invasive): Small registry and retrospective series suggest comparable toxicity and promising survival metrics with PBT combined with chemotherapy in trimodal approaches, but evidence limited by small sample sizes and short follow-up; NCCN does not address PBT for bladder cancer.

Brain and spinal cord tumors (adult diffuse gliomas, chordoma/chondrosarcoma, meningioma, low-grade glioma): Systematic reviews and prospective/retrospective series indicate comparable survival to photon RT and potential for reduced dose to healthy tissue and decreased neurocognitive/volume loss; ASTRO conditionally recommends PBT for reducing toxicity near critical organs; NCCN conditionally considers PBT in select CNS indications.

Breast cancer: Systematic reviews and technology assessments report low-quality evidence but suggest PBT may reduce doses to heart/lung and potentially reduce some adverse events; randomized trials lacking; NCCN does not address PBT for breast cancer.

Choroidal hemangiomas: Comparative retrospective data show similar visual outcomes between PBT and PDT for tumors <3 mm, and PBT may be preferable for tumors >3 mm to achieve single-session control.

Esophageal cancer: Meta-analyses and HTAs suggest PBT reduces OAR doses and certain toxicities (pneumonitis, pericardial effusion, lymphocytopenia) and may improve prognosis versus photon therapy in some analyses; evidence rated low quality and heterogeneous; NCCN states PBT is appropriate when OAR dose reduction is necessary and not achievable with 3D-CRT.

Non-metastatic rectal cancer and other GI cancers: Systematic review found insufficient evidence to demonstrate superior clinical outcomes with PBT despite dosimetric advantages reducing pelvic/bowel/bladder exposure.

Unproven Indications

Areas identified in the document as having limited or insufficient evidence:

Age-Related Macular Degeneration (AMD) — evidence uncertain; further research not justified until ongoing studies report.

Various ophthalmic indications beyond choroidal hemangioma/uveal melanoma — limited evidence and poor-quality studies.

Many GI malignancies (rectal cancer) — insufficient evidence to conclude superiority for adverse or oncologic outcomes.

Key definitions used in this policy: Definitive Therapy — radiation treatments for cancer with a curative intent; PBT — proton beam radiation therapy, a particle radiation modality using protons to concentrate dose within the tumor with minimal exit dose; OAR — organ at risk; PSPT — passive scattering proton therapy; and RBE — relative biologic effectiveness (the absorbed dose multiplied by the RBE factor for protons).

Selected evidence metrics

Skull base outcomes (chordoma/chondrosarcoma)1-,2-,3-,5-,7-year local control: 100%, 93%, 87%, 78%, 68%; low incidence of grade ≥3 late toxicities

HCC pooled outcomes (meta-analysis to Feb 2024)3- and 5-year local PFS: 88% and 86%; 3- and 5-year OS: 60% and 46%; grade 3+ hepatic toxicity ~1-2%

Ocular melanoma outcomes (systematic review)5-year local control >90%; 5-year OS 70–85%; 5-year enucleation ~7–10%; many retain purposeful vision

Intracranial AVM obliterationObliteration rates ~64.6% to 91% with longer follow-up; smaller nidus and higher dose associated with higher obliteration

AVM nidus/volume impactSmaller target volume and higher dose correlated with higher occlusion/obliteration rates (institutional series)

2025-06-01revisionLatest

Supporting Information (Clinical Evidence and References) sections were updated to reflect the most current information and new citations; previous policy version RADIOLOGY 045.7 was archived.

archived

Archived previous policy version RADIOLOGY 045.7.