ModifiedUnitedHealthcarePolicy CS105NE.U

Proton Beam Radiation Therapy (for Nebraska Only)

Clinical medical policy governing coverage and medical necessity criteria for proton beam radiation therapy for adults in Nebraska (policy applies to individuals 19 years and older; separate rules for those under 19).

Policy Summary

PayerUnitedHealthcare

PolicyProton Beam Radiation Therapy (for Nebraska Only)

Policy CodePolicy CS105NE.U

Change TypeMaterial updates to proven indications and exception criteria

Effective DateMay 1, 2026

Next Review DateN/A

Key ActionProvide documentation that photon techniques cannot achieve required normal-tissue sparing and include a comparison of PBT versus photon-based treatment plans for exception requests.

SourceLink

POLICY UPDATE CHANGES

Primary Head and Neck Cancers added as a proven and medically necessary indication when tumors are near critical structures or have intracranial extension or perineural invasion and when photon techniques cannot spare surrounding normal tissue.

Primary Central Nervous System Tumors added as a proven and medically necessary indication when tumors are near critical structures and when photon techniques cannot spare surrounding normal tissue.

Primary mediastinal tumors (e.g., thymomas, mediastinal lymphomas, thoracic sarcomas) added as proven indications.

Reirradiation added as a proven indication when prior radiation was to the same anatomical site and photon techniques cannot adequately spare surrounding normal tissue.

Expanded wording for primary liver malignancies replacing earlier HCC-specific language to include hepatocellular carcinoma and intrahepatic cancer (localized, unresectable) under curative setting when photon techniques cannot spare surrounding tissue and other liver-directed therapies are contraindicated or not feasible.

Coverage exception evaluation criterion changed from requiring comparison of PBT, IMRT, and SBRT plans to requiring comparison of PBT and photon-based radiation therapy plans (such as IMRT or SBRT) for the individual.

Removed CPT/HCPCS codes 77385, 77386, G6015, G6016, and G6017 from Applicable Codes.

Definitions added for Base of Skull Tumors, Central Nervous System Tumors, and Head and Neck Cancer; definition of 'Definitive Therapy' updated.

Removed reference link to the Medical Policy titled Intensity-Modulated Radiation Therapy (Nebraska Only).

Removed reference link to 'Medical Records Documentation Used for Reviews' guidelines.

Updated Clinical Evidence and References sections to reflect current information.

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May 1, 2026effective date

CS105NE.Upolicy id

Nebraskajurisdiction

Multiplecovered indications

64.6%AVM obliteration rate

19+policy applies to age

Coverage and Medical Necessity Criteria

Initial definitive therapy and reirradiation

Proton beam radiation therapy is proven and medically necessary for the following when specified conditions are met:

Proven indications list: Definitive therapy for: base of skull tumors (e.g., chordomas, chondrosarcomas, paranasal sinus, or nasopharyngeal tumors); primary head and neck cancers when ALL of the following are met: (1) tumors are near critical anatomical structures (orbit, skull base, cavernous sinus) or have intracranial extension or perineural invasion; AND (2) documentation shows sparing of surrounding normal tissue cannot be achieved with standard photon radiation therapy techniques; primary central nervous system tumors when ALL of the following are met: (1) tumors are near critical anatomical structures such as the optic nerve, brainstem, or spinal cord; AND (2) documentation shows sparing of surrounding normal tissue cannot be achieved with standard photon radiation therapy techniques; intracranial arteriovenous malformations; ocular tumors including intraocular/uveal melanoma (iris, ciliary body, choroid); primary liver malignancies (eg, hepatocellular carcinoma and intrahepatic cancer, localized, unresectable) in the curative setting WHEN documentation shows sparing cannot be achieved with standard radiation techniques (including IMRT, SBRT, selective internal radiation spheres) and transarterial therapy is contraindicated or not technically feasible; primary mediastinal tumors (eg, thymomas, mediastinal lymphomas, thoracic sarcomas); and reirradiation WHEN both: prior radiation was delivered to the same anatomical site; AND documentation shows sparing cannot be achieved with standard photon radiation therapy techniques.

See per-indication subconditions in policy text

Not listed/exception requests

Coverage for diagnoses not listed as proven may be considered on a case-by-case basis when BOTH criteria below are satisfied:

Exception criteria: 1) Documentation that sparing of surrounding normal tissue cannot be achieved with standard photon radiation therapy techniques; AND 2) Evaluation includes a comparison of treatment plans for proton beam therapy and photon-based radiation therapy (such as IMRT or SBRT) for the specific individual.

Requests for exceptions are evaluated case-by-case and require comparative planning

Prostate cancer

Specific stance on prostate cancer:

Prostate cancer equivalence: Proton beam therapy (PBT) and intensity-modulated radiation therapy (IMRT) are considered clinically equivalent for treating localized prostate cancer; principles of medical necessity will be applied when selecting modality.

No superiority established for PBT over IMRT—treat as equivalent

Guideline-aligned coverage criteria

Covered when clinical circumstances align with guideline recommendations and when photon therapy cannot meet normal tissue constraints or when sparing OARs provides added clinical benefit.

Guideline-aligned general criteria: PBT is considered medically necessary when (1) tumor location is adjacent to critical organs at risk such that standard photon techniques cannot meet dose constraints, OR (2) established guidelines (eg, ASTRO, NCCN, ACR/ARS) identify PBT as reasonable or recommended for the disease site; documentation must show intent (definitive vs palliative) and that photon alternatives were evaluated.

Justification should reference applicable guideline statements and comparative planning

Disease-specific coverage considerations

Consider PBT coverage in these disease‑specific contexts when clinical documentation supports treatment intent and demonstrates that photon techniques cannot meet normal tissue constraints:

Base of skull chordoma/chondrosarcoma: Postoperative or definitive PBT for skull‑base chordoma or chondrosarcoma is accepted when high‑dose conformal therapy is required and photon techniques cannot sufficiently spare adjacent critical neurovascular structures; evidence shows high long‑term local control in uncontrolled series.

Hayes assessment and systematic reviews support use

Head & neck tumors (selected): PBT may be appropriate for oropharyngeal and other head & neck cancers that are adjacent to OARs (eg, orbit, skull base, cavernous sinus), have intracranial extension, or extensive perineural invasion, where PBT reduces acute feeding‑tube use or better spares critical structures compared with IMRT and photon techniques cannot meet constraints.

Meta-analysis and guideline statements support conditional use

Primary CNS and spinal chordoma/chondrosarcoma: PBT is appropriate for primary CNS tumors located near optic apparatus, brainstem, or spinal cord when photon techniques cannot meet constraints; for unresected spinal/sacral chordoma, high‑dose PBT achieves substantial 5‑year local control in single‑institution series.

Intracranial AVMs — PSRS evidence

Intracranial arteriovenous malformations — evidence for single‑ and two‑fraction proton stereotactic radiosurgery (PSRS):

Single-fraction PSRS outcomes: Single‑fraction PSRS series (n=248 individuals, 254 AVMs) reported median nidus volume 3.5 cc, most common dose 15 Gy, 64.6% obliteration at median 35 months, 5‑ and 10‑year cumulative obliteration of 70% and 91% respectively; posttreatment hemorrhage occurred only in lesions without total obliteration with a 5‑year cumulative incidence of 7% (three fatal events).

Smaller target volume and higher dose associated with higher obliteration

Two-fraction PSRS outcomes: Two‑fraction PSRS in high‑risk AVMs (median nidus vol 23 cc) most commonly delivered 16 Gy in 2 fractions; total obliteration achieved in 15% with partial in 34%; 5‑year actuarial hemorrhage 22% with 14% fatal hemorrhage; higher total dose associated with greater obliteration but overall lower complete obliteration compared with single‑fraction series.

Authors recommend consideration of higher doses or multistage approaches for resistant lesions

Ocular tumors — PBT evidence and guidance

Ocular (uveal/choroidal) melanoma — systematic reviews, meta‑analysis, and case series:

Meta-analysis outcomes: Meta‑analysis of six case series (1,059 individuals) reported OS 97% at 2y, 92% at 3y, 73% at 5y, and 39% at 10y; LC 98% at 1y, 92% at 3y, 94% at 5y, and 88% at 10y; common adverse events include glaucoma, optic neuropathy, and cataracts.

Evidence primarily retrospective; prospective trials limited

Feasibility and institutional series: Single‑institution feasibility series (n=26) demonstrated tolerability and maintenance of low anterior structure dose with mixed visual acuity outcomes and minimal acute toxicity.

Treatment should be performed by experienced multidisciplinary teams per NCCN

Guideline context: NCCN identifies particle beam therapy as a common definitive RT for uveal melanoma and recommends treatment by an experienced ophthalmic oncology and proton therapy team.

ASTRO model policy notes PBT reasonable when photon RT cannot adequately spare surrounding tissue

Primary liver malignancies — PBT evidence

Hepatocellular carcinoma (HCC) and intrahepatic cholangiocarcinoma (ICC) — evidence for PBT:

Pooled outcomes for HCC/ICC: Meta‑analysis of 22 studies (1,858 individuals) reported pooled 3‑ and 5‑year local PFS of 88% and 86% and pooled 3‑ and 5‑year overall survival of 60% and 46%; low rates of grade 3 hepatic toxicity were reported.

Heterogeneity and lack of RCTs limit certainty

Randomized trial vs TACE: An RCT (Bush et al. 2023) comparing PBT vs TACE in transplant‑eligible HCC found similar 2‑year OS (68% vs 65%) but significantly longer PFS and superior local control with PBT and fewer posttreatment hospitalization days.

Supports PBT as alternative to TACE for selected patients

Dose/fractionation observations: Hypofractionated and dose‑escalated PBT series report high 1‑year local control (~90%); higher BED (>75.2 GyE) associated with improved 1‑year LC in pooled registries.BED > 75.2 GyE associated with higher 1‑year LC

Primary mediastinal tumors — PBT evidence and guidance

Mediastinal lymphoma and thymic tumors — PBT potential benefits and guidance:

Systematic review for mediastinal lymphoma: Systematic review of 11 case series (529 individuals) reported favorable 2‑year OS (91%–98%) and PFS (73%–94%) with generally mild toxicities; evidence limited to case series.

Well‑designed RCTs needed

Dosimetric and clinical outcomes: Retrospective comparative series (n=20) showed PBT reduced mean heart dose by ~3.3 Gy and reduced breast dose in females compared with IMRT while maintaining target coverage and demonstrating high PFS with low toxicity.

PBT can reduce OAR exposure without compromising coverage

Thymic tumors outcomes: Prospective series (n=27) reported 100% local control at median 2‑year follow‑up with minimal grade ≥3 toxicities and reduced doses to surrounding tissues, supporting selective use of PBT.

Small samples and limited follow‑up

Guideline-supported appropriate scenarios for PBT/advanced RT

Guideline‑supported appropriate scenarios for PBT or other advanced RT techniques (examples):

Thymic malignancies: Advanced RT techniques (IMRT or PBT) are recommended over 3D‑CRT to reduce cardiac and pulmonary exposure; PBT offers further dosimetric advantages in selected patients.

ARS and NCCN recommendations

Mediastinal lymphomas: PBT may be appropriate for individuals with mediastinal disease involving cardiac structures, for young females to reduce breast dose, and for heavily pretreated patients at increased risk of toxicity; careful selection is required.

ILROG and NCCN guidance

Reirradiation: PBT/charged‑particle therapy may be appropriate for individualized reirradiation cases where prior dose, overlap, and OAR proximity make photon re‑treatment high risk; planning must be individualized.

NCCN recommends individualized approach

Coverage-relevant summaries by indication

Coverage‑relevant summaries by indication (evidence strength and policy implications):

Unproven indications (general): For multiple indications, evidence quality is limited and RCT data are lacking; these uses are considered unproven and not established as routine indications for PBT without additional high‑quality data.

See specific unproven entries below

Age‑related macular degeneration: Systematic reviews and RCTs show uncertain benefit of RT/PBT for neovascular AMD; evidence does not support routine use and outcomes are unclear.

Evans et al. 2020 concluded evidence uncertain

Muscle‑invasive bladder cancer: Small registry and series data report promising short‑term outcomes with PBT plus chemotherapy, but evidence is limited with short follow‑up and small samples; PBT is not established as standard of care.

Araya et al. 2023 and others report limited evidence

Guideline contextual criteria

Guideline contextual criteria relevant to coverage decisions:

Esophageal cancer guidance: NCCN: PBT is appropriate when dose reduction to organs at risk is necessary and cannot be achieved by 3D‑CRT; because data are evolving, NCCN recommends PBT in a clinical‑trial setting when possible.

Supports limiting routine use outside trial settings

Photon‑first preference for esophageal cancer: STS/ASTRO guidance: IMRT is increasingly preferred over 3D‑CRT for esophageal cancer and should be used when it can meet OAR constraints, suggesting a photon‑first approach before PBT when IMRT is sufficient.

Indicates attempt advanced photon techniques prior to PBT when feasible

Gynecologic RT standards: SGO/ASTRO/ABS consensus: IMRT and image‑guided brachytherapy are quality benchmarks for cervical cancer; PBT is not specifically addressed as a standard in this consensus.

No routine endorsement of PBT for gynecologic indications

Evidence summaries (selected indications)

Selected evidence summaries that inform policy context (selected indications):

NSCLC evidence summary: Single‑center retrospective series (Sejpal et al.) reported PBT delivered higher median dose (74 Gy) with lower rates of severe pneumonitis and esophagitis compared with historical 3D‑CRT and IMRT controls, but follow‑up was short and tumor control/survival were not reported.

Encouraging but nonrandomized data

Charged particle therapy for lung: Systematic reviews concluded that charged particle therapy for lung cancer is encouraging but lacks phase 3 trials; authors recommend particle therapy be considered experimental until phase 3 data are available.

Impacts coverage consideration for lung cancer

Pancreatic cancer evidence: Robust clinical evidence for PBT in pancreatic cancer is lacking; larger prospective studies are warranted.

No routine coverage established based on current data

Proven/Medically Necessary Indications (added/revised)

Covered when ALL of the following are met for the newly added or revised proven indications:

Primary Head and Neck Cancers (added): Primary head and neck tumors located near critical anatomical structures (eg, orbit, skull base, cavernous sinus), or with intracranial extension or perineural invasion; AND documentation shows sparing of surrounding normal tissue cannot be achieved with standard photon radiation therapy techniques.

Added as proven/medically necessary indication in 05/01/2026 revision

Primary Central Nervous System Tumors (added): Primary CNS tumors (eg, brain or spinal cord) located near critical anatomical structures such as the optic nerve, brainstem, or spinal cord; AND documentation shows sparing of surrounding normal tissue cannot be achieved with standard photon radiation therapy techniques.

Added as proven/medically necessary indication in 05/01/2026 revision

Primary Mediastinal Tumors (added): Primary mediastinal tumors (eg, thymomas, mediastinal lymphomas, thoracic sarcomas) meeting site‑specific criteria per policy text and when photon techniques cannot meet necessary OAR constraints.

Proton beam radiation therapy (PBT) is designated not medically necessary for indications other than those explicitly listed as proven and medically necessary in this policy unless a documented exception is approved. Exception requests will be evaluated on a case-by-case basis and must meet both of the following requirements: (1) clear documentation that sparing of surrounding normal tissue cannot be achieved with standard photon radiation therapy techniques; and (2) the evaluation includes a comparison of treatment plans for PBT and photon-based radiation therapy (for example, IMRT or SBRT) for the specific individual. Absent these criteria, PBT for unlisted indications is considered unproven and not medically necessary.

Randomized evidence (ARUBA) evaluating adults with unruptured intracranial arteriovenous malformations (AVMs) showed that conservative management provided superior functional outcomes at 1 year compared with interventional treatment (which included endovascular, surgical, and/or radiotherapy approaches). Intervention increased the risk of death or dependency and symptomatic intracranial hemorrhage during the first year. These trial results should inform decision making for AVM management and support careful patient selection and risk discussion when considering PBT/PSRS for unruptured AVMs.

Evidence supporting PBT for ocular tumors (including uveal/choroidal melanoma) is largely derived from retrospective case series and meta-analyses of nonrandomized data. Systematic reviews report high local control and favorable short-term survival, but authors emphasize the absence of high-quality randomized controlled trials and recommend further prospective comparative research to better define comparative effectiveness and long-term outcomes.

Some indications are explicitly categorized as unproven because the peer‑reviewed literature is limited in quality or yield inconsistent results. An example is neovascular age-related macular degeneration (AMD): systematic reviews and randomized trials have not demonstrated convincing benefit of radiation approaches, and outcomes remain uncertain. For conditions labeled unproven, randomized controlled trials with modern techniques and contemporaneous standard therapies are required before routine coverage can be supported.

When an indication is labeled Unproven in this policy, it means the current evidence does not establish sufficient clinical benefit compared with standard approaches; as a result, the indication is generally considered not medically necessary for routine coverage. Exceptions may be considered only when the policy’s exception criteria are satisfied and documentation demonstrates that photon-based techniques cannot achieve the necessary normal tissue sparing.

Systematic reviews and early clinical series conclude that charged particle therapy for lung cancer remains experimental pending confirmatory randomized phase 3 data. While single-center series have reported the feasibility of delivering higher radiotherapy doses with PBT and lower rates of some severe toxicities, the absence of phase 3 evidence means charged particle therapy for lung cancer should not be considered established standard therapy at this time.

Multiple evidence reviews and authors have explicitly characterized charged particle therapy for lung cancer as experimental in the absence of phase 3 randomized trial results. Until phase 3 trials provide confirmatory data, routine coverage for charged particle therapy in lung cancer is not supported by high‑quality evidence.

This Medical Policy is intended to assist interpretation of UnitedHealthcare standard benefit plans; it does not supersede applicable federal, state, or contractual benefit plan terms. In the event of conflict between this policy and plan-specific or statutory requirements, the federal, state, or contractual provisions govern coverage decisions.

Restating the policy position: PBT is unproven and not medically necessary for indications not specifically listed as proven and medically necessary in this document unless the documented exception criteria are met (demonstration that photon techniques cannot achieve required normal tissue sparing and submission of comparative PBT versus photon-based treatment planning). Requests lacking these elements are subject to denial.

Some combined or interventional treatment approaches have only limited evidence from small, nonrandomized series. For example, reports of PBT combined with intra-arterial chemotherapy for advanced head and neck cancers show promising outcomes but are limited by small sample sizes and lack of comparative controls. Such combination strategies should be considered experimental or investigational until higher‑quality comparative trials are available.

ASTRO’s model policy indicates that PBT is reasonable when equivalent normal tissue sparing cannot be achieved with photon radiation therapy, implying that PBT may be considered appropriate when a documented dosimetric advantage over photons is required to protect critical organs at risk.

Neovascular age-related macular degeneration (AMD) lacks convincing, contemporary evidence to support routine use of radiation, including PBT. Systematic reviews conclude that available trials were performed before current anti‑VEGF standards and that outcomes are uncertain—therefore routine PBT for neovascular AMD is unsupported.

Overall, systematic reviews of ocular indications report methodological limitations and heterogeneous techniques, and they do not demonstrate clear benefit of radiation for AMD or other non‑melanoma ocular conditions. Consequently, radiation therapy (including PBT) for neovascular AMD is not supported as standard care based on current evidence.

For many gastrointestinal malignancies the body of evidence remains limited in quality: systematic reviews note small studies, heterogeneous techniques, and a paucity of randomized comparisons. While some signals of dosimetric and toxicity benefit exist for selected sites (for example HCC), the authors emphasize the need for further multi‑institution randomized trials before broader coverage can be routinely supported.

No clinical evidence was identified supporting the practice of combining PBT and IMRT within a single treatment plan. As such, combined PBT+IMRT planning and delivery for the same target in a single course is unsupported by the literature cited in this policy.

This section does not list additional explicit conditions labeled as Not Medically Necessary beyond the general statements and exclusions already provided. The policy’s exclusion and exception language (and supporting evidence summaries) govern determinations about unlisted indications.

Applicable Procedure and Diagnosis Codes

Applicable CPT/Procedure CodesCPT

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 construction per IMRT plan
77387	Guidance for localization of target volume for delivery of radiation treatment, includes intrafraction tracking, when performed
77520	Proton treatment delivery; simple, without compensation
77522	Proton treatment delivery; simple, with compensation
77523	Proton treatment delivery; intermediate
77525	Proton treatment delivery; complex

Applicable ICD-10 CodesICD-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 wall of nasopharynx
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

Removed Applicable CPT/HCPCS Codesmixed

77385	removed
77386	removed
G6015	removed
G6016	removed
G6017	removed

Biologically effective dose (BED)

Biologically effective dose (BED)105.6 Gy (RBE) — outcomes (OS, DFS, LC) improved when BED ≥ 105.6 Gy (RBE) in hypofractionated PBT for early-stage NSCLC

Median BED reportedMedian biologically effective dose delivered in pooled hypofractionated PBT studies was 105.6 Gy (RBE)

Clinical trade-offHigher BED (≥105.6 Gy[RBE]) associated with better disease outcomes but with increased late grade ≥2 toxicity (rib fractures noted)

Prior Authorization, Documentation, and Operational Guidance

Prior Authorization

Prior authorization expectations (guideline-aligned)

Prior authorization is required for proton beam therapy (PBT) requests when guideline-aligned indications are being sought. Requests should reference disease-site guidance (for example, skull base tumors, ocular tumors, mediastinal lymphomas, select CNS tumors, and reirradiation scenarios) and demonstrate that photon-based techniques (IMRT/VMAT/3D-CRT/SBRT) cannot meet normal tissue dose constraints. Authorization reviews will consider published guideline recommendations (ASTRO, NCCN, ILROG) and require clinical justification tied to the individual member.

Prior authorization should include citation of relevant guideline statements when applicable.
Requests for indications not listed as proven will be reviewed as exceptions (see exception criteria).

Prior Authorization

Prior authorization: center expertise and clinical justification

Authorization evaluations must include documentation of the treating center’s multidisciplinary expertise and specific clinical justification for PBT. Requests for complex disease sites (ocular tumors, mediastinal disease, reirradiation) should indicate availability of experienced specialists (e.g., ophthalmic oncologist for uveal melanoma, lymphoma radiation oncologist) and institutional proton physics support.

Key Definitions

Base of Skull Tumors

DefinitionLesions arising in the anatomically complex skull base region (anterior cranial fossa, clivus, petrous bone, middle cranial fossa, cavernous sinus, infratemporal fossa).

Common tumor typesIncludes chordomas and chondrosarcomas.

Clinical importanceTumors often adjacent to critical neurovascular and endocrine structures where PBT may spare surrounding tissue compared with photons.

Central Nervous System Tumors

DefinitionTumors originating in the central nervous system, including brain and spinal cord neoplasms (examples: brainstem glioma, craniopharyngioma, medulloblastoma, meningioma).

Anatomical scopeIncludes intracranial and intraspinal primary neoplasms.

Clinical Evidence and Rationale

The policy’s coverage stances are informed by evidence summaries that vary by indication. Where randomized trial evidence is lacking or low quality, indications are often labeled Unproven and not routinely covered (examples include AMD, some GI sites, and select solid tumors). For certain disease groups—such as skull base chordoma/chondrosarcoma, select ocular tumors, primary mediastinal tumors, and reirradiation—higher quality observational data, guideline endorsements, and dosimetric rationale support coverage when plan comparison and documentation show photon techniques cannot meet normal tissue constraints.

The ARUBA randomized trial context is explicitly applied to AVM management: although proton stereotactic radiosurgery series report substantial obliteration rates in selected series, ARUBA demonstrates that interventions for unruptured AVMs increased the risk of death or dependency at one year compared with conservative management. This trial therefore tempers enthusiasm for routine interventional radiotherapy in unruptured AVMs and supports strict selection and justification when PBT/PSRS is considered.

Evidence for combined or interventional approaches is limited. Small, single‑institution reports describe PBT combined with intra‑arterial chemotherapy for advanced head and neck cancers, but these studies lack randomized comparison groups. Similarly, no evidence supports combining PBT and IMRT in a single treatment plan. Higher‑quality randomized trials are necessary to validate combined or multimodality strategies before routine coverage can be recommended.

High‑quality evidence is limited for select gastrointestinal malignancies. While pooled HCC studies and a randomized trial versus TACE suggest promising local control and progression‑free survival with PBT in selected patients, the overall heterogeneity and lack of large multi‑institution RCTs for many GI sites mean broader routine coverage is not supported without further confirmatory trials.

Policy Changes and Effective Dates

Guideline and evidence summaries for lung cancer emphasize that charged particle therapy remains investigational until phase 3 data are available. Retrospective series report potential dosimetric and toxicity advantages with PBT, but systematic reviews and the absence of phase 3 randomized trials underpin the experimental classification and the policy’s conservative coverage approach for lung indications.

Policy Summary

PayerUnitedHealthcare

PolicyProton Beam Radiation Therapy (for Nebraska Only)

Policy CodePolicy CS105NE.U

Change TypeMaterial updates to proven indications and exception criteria

Effective DateMay 1, 2026

Next Review DateN/A

Key ActionProvide documentation that photon techniques cannot achieve required normal-tissue sparing and include a comparison of PBT versus photon-based treatment plans for exception requests.

SourceLink

On This Page

Systematic reviews and prospective/retrospective series cited

Intracranial AVMs: PBT/PSRS may be considered for cerebral AVMs with demonstrated occlusion rates in single‑ and multi‑fraction series; selection must weigh ARUBA trial findings for unruptured AVMs and individual hemorrhage risk.

High obliteration rates reported but RCT (ARUBA) cautions about intervention for unruptured AVMs

Ocular (uveal) melanoma: PBT is an accepted definitive RT option for uveal melanoma (iris, ciliary body, choroid) and is appropriate when performed by an experienced multidisciplinary team; evidence from meta‑analyses shows high local control and survival but is primarily retrospective.

NCCN and systematic reviews support use at experienced centers

Primary liver malignancies: For localized, unresectable primary liver malignancies (HCC, intrahepatic cholangiocarcinoma) in the curative setting, PBT may be covered when photon techniques (including IMRT, SBRT, and selective internal radiation spheres) cannot adequately spare uninvolved liver and when transarterial therapies are contraindicated or not feasible; evidence includes pooled series and an RCT vs TACE showing improved local control and PFS in selected patients.

Guideline endorsements (ASTRO/NCCN) support hypofractionated/dose‑escalated PBT in select cases

Primary mediastinal tumors: PBT may be appropriate for thymomas, mediastinal lymphomas, and thoracic sarcomas when dosimetric advantages over IMRT are clinically meaningful (eg, heart or breast dose reduction), with selection based on guideline and ILROG/ARS recommendations.

Evidence from case series and consensus guidance supports selective use

Reirradiation: PBT is considered for reirradiation when individuals previously received radiation to the same anatomical site and documentation demonstrates that standard photon techniques cannot adequately spare surrounding normal tissue; decisions must account for prior dose, overlap, OAR proximity, and time since prior RT.

Reirradiation added as proven indication with individualized planning

ASTRO and NCCN support IMRT or PBT for dose‑escalated hypofractionated EBRT in selected patients

Guideline recommendations: ARS and ILROG recommend IMRT or PBT over 3D‑CRT for thymic malignancies and identify subgroups most likely to benefit (eg, disease adjacent to heart, young females, heavily pretreated individuals).

Patient selection emphasized due to limited availability

Anal cancer (reirradiation or constraint-limited cases): ASTRO strongly supports IMRT for anal cancer; PBT may be considered for reirradiation or when IMRT cannot meet OAR constraints (eg, pelvic kidneys, fertility preservation).

Prostate cancer: Guidelines consider PBT an option but not superior to IMRT; use should be individualized and not routine based on superiority claims.

AUA/ASTRO and NCCN positions

Breast cancer (adjuvant/postmastectomy): Systematic reviews indicate potential dosimetric and toxicity advantages with PBT but evidence is low quality without RCTs; routine adoption is unsupported pending higher‑quality comparative data.

Holt et al. 2023 and other reviews highlight need for trials

Esophageal cancer: Meta‑analyses report reduced OAR dose and some toxicity benefits with PBT and potential prognosis improvements in pooled analyses, but heterogeneity and absence of definitive RCT evidence limit broad coverage; guideline recommendations favor clinical‑trial use where available.

Zhou et al. 2023 and NCCN guidance

Vestibular schwannoma evidence: Meta‑analysis of PBRT for vestibular schwannoma reported high tumor control (~95.4%) but limited hearing preservation (~40.6%) and no demonstrated advantage over standard stereotactic radiosurgery for cranial nerve preservation; data mainly retrospective.

Clinical tradeoffs should be considered

Added as proven/medically necessary indication

Reirradiation (added): Individuals previously underwent radiation to the same anatomical site and now require an additional course to that same site; AND documentation shows sparing of surrounding normal tissue cannot be achieved with standard photon radiation therapy techniques.

Added as proven/medically necessary indication

Primary Liver Malignancies (revised): Primary liver malignancies such as hepatocellular carcinoma and intrahepatic cancer (localized, unresectable) in the curative setting when documentation shows sparing of surrounding normal tissue cannot be achieved with standard radiation therapy techniques (including IMRT, SBRT, selective internal radiation spheres) and transarterial therapy is contraindicated or not technically feasible.

Replaced prior HCC‑specific language with broader primary liver malignancies wording

List key team members and their roles in the record (radiation oncologist, medical physicist, relevant surgical or medical oncology specialists).
State center experience with the specific disease site and proton program caseload if available.

Prior Authorization

Selective prior authorization recommended for mediastinal/thymic/reirradiation scenarios

Selective prior authorization is recommended for mediastinal, thymic, and reirradiation scenarios. For mediastinal lymphomas or thymomas, PBT may offer substantial OAR sparing but should be reserved for cases with clear dosimetric advantage over advanced photon techniques. Reirradiation decisions must be individualized based on prior dose, target location, and overlap with organs at risk.

For mediastinal disease provide dosimetric comparison showing reduced heart, lung, or breast dose with PBT versus IMRT/VMAT.
For reirradiation include prior radiation records (dose, fractionation, fields) and an explicit plan showing cumulative OAR constraints.

Prior Authorization

Prior authorization for PBT in multimodality therapy

When PBT is requested as part of multimodality therapy (for example, bladder-sparing trimodality approaches or esophageal chemoradiation), prior authorization should document why photon-first approaches (IMRT/VMAT) are insufficient to meet OAR constraints or would compromise standard multimodality treatment. Guidelines generally favor photon-based approaches for many multimodality settings unless a dosimetric advantage for PBT is shown.

Provide comparison plans and rationale when PBT is proposed in a multimodality protocol.
If guideline-recommended photon-first strategies exist (e.g., bladder trimodality, esophageal IMRT), explain why they are not appropriate for this individual.

Prior Authorization

Prior authorization recommended when OAR dose reduction needed

Prior authorization is recommended whenever reduction of dose to critical organs-at-risk (OARs) is the justification for PBT. Provide objective dosimetric evidence that OAR dose reduction cannot be achieved with advanced photon techniques (IMRT/VMAT/SBRT) and that PBT will meaningfully reduce expected late toxicity.

Include dosimetric constraints and quantitative OAR dose comparisons (DVHs) for PBT versus photon plans.
When NCCN or ASTRO notes PBT is appropriate only if OAR constraints cannot be met, explicitly state that photon plans were attempted and failed to meet constraints.

Prior Authorization

PBT may be appropriate for NSCLC when needed

PBT may be appropriate for non–small cell lung cancer (NSCLC) when required to deliver curative radiation safely or to limit normal tissue dose. However, charged particle therapy for lung cancer is considered experimental in the absence of phase 3 trial evidence; requests should include rationale, trial availability, and dosimetric comparisons.

Provide 4D-CT/motion management details and demonstrate how PBT reduces lung or heart dose compared with IMRT/3D-CRT.
If used outside of a clinical trial, document why trial enrollment is not feasible and include plan comparison data.

Prior Authorization

Plan comparison required for exceptions

Exception requests for PBT (diagnoses not listed as proven) must include a clear plan comparison of PBT versus photon-based radiation therapy (IMRT, VMAT, or SBRT as applicable). The evaluation will consider whether PBT provides a meaningful dosimetric and clinical advantage for the specific individual.

Attach comparative treatment plans (dose–volume histograms) and a concise interpretation of expected normal-tissue benefit.
Failure to provide plan comparison may result in denial of the exception request.

Documentation Required

Documentation requirement

Medical records documentation must fully support the medical necessity of the requested PBT. The patient’s record should be legible and include relevant history, physical exam findings, diagnostic testing, imaging, prior treatments, and rationale for PBT. Lack of adequate documentation may result in denial or payment recovery.

Include prior radiation records when applicable and make all supporting documentation available upon request.
Clinical notes must state why photon therapy cannot adequately spare normal tissues when that is the stated justification.

Note

AVM intervention risks from ARUBA trial

When intracranial arteriovenous malformations (AVMs) are considered for intervention, reviewers should note ARUBA trial results showing increased death or dependency with interventional treatment versus conservative management at 1 year. This risk profile should be documented in the clinical justification when stereotactic or radiotherapeutic interventions (including PBT) are proposed for unruptured AVMs.

Document alternative management discussions and rationale for intervention despite ARUBA findings.
Include expected benefits and potential risks in consent and prior authorization materials.

Note

ASTRO contextual guidance

ASTRO guidance emphasizes that PBT is reasonable when photon therapy cannot adequately spare surrounding normal tissue and when PBT provides added clinical benefit to the individual. Cite ASTRO statements when using this rationale in authorization requests.

Use ASTRO model policy language to support requests that demonstrate anatomic or dosimetric situations where photons fail to meet constraints.

Note

Minimum technological requirement for RT

A minimum technological requirement for treating thymomas and thymic carcinomas is 3D-CRT; however, more advanced techniques (IMRT/VMAT) are recommended to reduce cardiac dose. Proton therapy may offer further dosimetric advantage but should be justified by comparative planning.

If requesting PBT for thymic malignancies, include photon and proton plan comparisons and show cardiac substructure dose reductions.

Denial Risk

Unproven indications risk

Indications listed as 'Unproven' carry higher risk of noncoverage. For these diagnoses, prior authorization should include strong supporting evidence or plan-comparison data; absent that, requests are likely to be denied as not medically necessary.

Identify whether the requested indication is listed in the policy as unproven and provide rationale and supporting literature if available.

Prior Authorization

NCCN position on PBT for esophageal cancer

For esophageal cancer, NCCN states PBT is appropriate when dose reduction to OARs is necessary and cannot be achieved by 3D-CRT; given evolving evidence, NCCN recommends treating individuals on clinical trials when possible.

When requesting PBT for esophageal cancer, include plan comparisons and note availability or ineligibility for ongoing trials (e.g., NCT03801876).

Note

Combined PBT+IMRT unsupported

No evidence supports combining PBT and IMRT simultaneously within a single treatment plan. Authorization requests proposing concurrent mixed-modality plans must include justification and will be scrutinized; combined-use claims lack supporting literature.

If a hybrid approach is proposed, provide clinical rationale and any supporting institutional data.

Documentation Required

Suggested clinical documentation elements

Suggested clinical documentation elements to include with authorization requests: tumor site and stage, histology, prior surgeries, prior radiation doses and fields, current staging studies, planning CT/PET imaging, expected dose/fractionation, intended technique (proton type, passive scatter vs pencil beam), and planned concurrent therapies.

State whether PBT will be used alone or in combination with photons and provide detailed treatment planning parameters.
Report follow-up and toxicity assessment plans and any relevant performance status measures.

Documentation Required

Center and team expertise

Center and team expertise should be documented: list multidisciplinary team members, program volume/experience for the disease site, and physics/quality assurance processes. NCCN recommends experienced multidisciplinary teams when performing particle beam therapy for uveal melanoma and other complex sites.

Provide center proton program caseload for the specific disease site when available.
Document available support for motion management, image guidance, and particle therapy QA.

Prior Authorization

Reirradiation treatment decisions must be individualized

Reirradiation treatment decisions must be individualized. Prior authorization should include prior radiation dose, time since prior RT, cumulative dose estimates to OARs, and a proposed plan that minimizes overlap and respects organ tolerance.

Include prior treatment records and cumulative DVH analyses.
Explain the clinical intent (curative vs palliative) and expected benefit of reirradiation.

Documentation Required

Clinical documentation expectations

Clinical documentation expectations commonly reported in the literature include staging details, concurrent systemic therapies, performance status, toxicity grades, and follow-up schedule. Submitters should include these elements to facilitate review.

Report baseline toxicity grades and planned toxicity monitoring intervals.
Document rationale for dose and fractionation choices.

Documentation Required

Treatment details to document

Treatment details to document: whether PBT is planned alone or with photons, histology, total dose and fractionation, beam arrangement and delivery technique (passive scatter vs pencil-beam scanning), motion management, image guidance, and intended OAR constraints.

Attach the proposed treatment plan, contour set, and DVHs for target and OARs.
Detail immobilization and verification procedures.

Documentation Required

Toxicity monitoring schedule (example from literature)

Toxicity monitoring schedules used in published studies are an example for documentation: baseline CTCAE assessment, weekly assessments during RT, posttreatment visits at 4–6 weeks, then every 3 months for 2 years, then every 6 months thereafter, with long-term assessment of late effects.

Include planned schedule for toxicity assessment and patient-reported outcomes if available.
State which CTCAE version will be used for grading.

Prior Authorization

Consider photon modalities before PBT when feasible

When feasible, photon modalities (IMRT/VMAT) should be attempted or demonstrated in planning comparisons prior to approval of PBT. ASTRO and NCCN frequently recommend photon-first approaches when constraints can be met; PBT is considered when photons fail to achieve acceptable OAR sparing.

Provide photon plans and evidence they do not meet target coverage and OAR constraints prior to requesting PBT.
State why IMRT/VMAT would be insufficient for this individual.

Note

ASTRO supports IMRT for anal cancer and suggests PBT only when necessary

ASTRO supports IMRT as the primary modality for anal cancer and suggests PBT only when IMRT cannot meet OAR dose constraints or in reirradiation settings. Authorization for PBT in anal cancer should therefore include evidence that IMRT is inadequate.

Provide IMRT plan comparisons and explain why IMRT fails to meet constraints if PBT is requested.

Prior Authorization

Preferred photon-first approach for esophageal cancer

For esophageal cancer, a photon‑first approach (IMRT preferred over 3D‑CRT) is recommended; PBT is considered when dose reduction to OARs cannot be achieved with 3D‑CRT and, given limited evidence, enrollment in clinical trials is encouraged.

If requesting PBT, include IMRT plan comparisons and trial availability/eligibility information.

Denial Risk

Charged particle therapy considered experimental for lung cancer in absence of phase 3 data

Charged particle therapy for lung cancer should be considered experimental outside of clinical trials until phase 3 evidence demonstrates superiority. Authorization requests for lung PBT should reference ongoing trials or provide robust dosimetric and clinical rationale.

Document trial identifiers when applicable and provide justification for off-trial use.
Include motion management strategy and plan comparison to photon therapy.

Relevance to PBTOften located near critical OARs (optic apparatus, brainstem, spinal cord) where proton therapy may reduce dose to normal tissue.

Definitive Therapy

DefinitionRadiation treatments delivered with curative intent (aimed to eliminate disease).

Source guidanceDefinition aligned with NCI and NCCN descriptions of curative-intent therapy.

Policy contextUsed to distinguish definitive therapy indications eligible for PBT when other criteria are met.

Head and Neck Cancer

DefinitionCancers arising in tissues of the head and neck region (nasal cavity, sinuses, oral cavity, salivary glands, pharynx, larynx), typically squamous cell carcinomas.

Risk factorsIncludes tobacco, alcohol, and high-risk HPV infection.

Coverage relevancePBT may be considered when tumors are near critical structures or when photon techniques cannot meet OAR constraints.

Organs at risk (OAR)

DefinitionCritical normal structures near the tumor (eg, optic nerves, brainstem, hippocampus, cochleae) where minimizing radiation dose preserves function.

Policy implicationOAR dose reduction is a common justification for PBT when photon techniques cannot meet constraints.

ExamplesIncludes cardiac substructures, lungs, kidneys, and reproductive organs in thoracic/pelvic settings.

Proton stereotactic radiosurgery (PSRS)

DefinitionHigh-precision proton therapy delivered in single or few fractions for small intracranial targets (eg, AVMs).

Typical useUsed for single-fraction or two-fraction treatment of cerebral arteriovenous malformations (PSRS series report varying obliteration rates).

Clinical noteTechnique aims for focused dose with rapid falloff to spare adjacent critical structures.

PSRS — proton beam stereotactic radiosurgery

DefinitionSingle- or multi-fraction focused proton treatment specifically used for intracranial arteriovenous malformations (AVMs).

Outcomes summarySingle-fraction series reported 64.6% obliteration at median 35 months; two-fraction series reported lower total obliteration rates for large/high-risk AVMs.

Safety considerationsPosttreatment hemorrhage risk persists among incompletely obliterated lesions; selection is critical due to ARUBA trial findings for unruptured AVMs.

GyE — Gray equivalent

DefinitionGray equivalent (GyE) — dose unit used in proton therapy studies to express proton dose adjusted for relative biological effectiveness.

Usage exampleReported in liver malignancy PBT series (eg, median total dose ranged 55–76 GyE, median 69 GyE).

InterpretationGyE facilitates comparison of proton dose schedules with photon-based dosing conventions.

Advanced RT techniques

DefinitionRadiation methods beyond 3D-conformal RT, including IMRT, VMAT, and proton beam radiation therapy, designed to improve conformality and spare OARs.

Clinical roleAdvanced techniques are recommended when 3D-CRT cannot meet organ-at-risk constraints or when dose escalation is needed with acceptable toxicity.

Policy relevancePBT is categorized among advanced RT techniques and considered when photon-based advanced techniques cannot sufficiently spare normal tissue.

Charged particle therapy

DefinitionRadiation therapy using charged particles such as protons, carbon ions, or helium/neon, employed for site-specific indications or reirradiation scenarios.

Clinical contextsUsed for reirradiation of skull base and head & neck tumors and select primary sites where dosimetric advantages may reduce toxicity.

Evidence noteEvidence largely from retrospective series and single-institution studies; prospective multi-institutional data are often limited.

Choroidal neovascularization due to AMD

DefinitionChoroidal neovascularization secondary to age-related macular degeneration (neovascular AMD) — growth of abnormal vessels under the retina causing vision loss.

Evidence summarySystematic reviews and RCTs of RT for neovascular AMD report uncertain benefit; most studies predate routine anti-VEGF therapy and modern RT techniques.

Policy implicationRT/PBT for neovascular AMD is considered unproven due to limited quality evidence.

Hypofractionated PBT

DefinitionHypofractionated proton beam therapy defined as ≥ 3 Gy(RBE) per fraction (Volpe et al.) used in curative-intent treatment of early-stage NSCLC.

Typical regimen contextMedian BED in pooled hypofractionated PBT studies was 105.6 Gy (RBE); higher BED associated with improved OS and LC.

Toxicity noteHigher BED associated with increased late grade ≥2 toxicities (eg, rib fractures).

PSPT — Passive scattering proton therapy

DefinitionPassive scattering proton therapy (PSPT) — a proton delivery technique compared with IMRT in a randomized trial for inoperable NSCLC.

Trial contextPSPT exposed less low-dose lung but more intermediate-to-high dose lung compared with IMRT; grade ≥3 pneumonitis was numerically higher with PSPT in that trial.

Clinical implicationTechnique and institutional experience can influence outcomes; plan comparisons are important when choosing modality.

Common Terminology Criteria (CTCAE) v3.0

DefinitionCommon Terminology Criteria for Adverse Events (CTCAE) v3.0 — standardized toxicity grading system used in cited NSCLC series (Sejpal et al.).

Use caseToxicities were assessed weekly during treatment, at 4–6 weeks posttreatment, then periodically up to years of follow-up as described in the study.

InterpretationCTCAE provides consistent grading for comparisons across studies and modalities.

Base of Skull Tumors (added definition)

Definition (added)Base of Skull Tumors — diverse lesions arising in the base of skull region, often adjacent to critical neurovascular structures.

ExamplesIncludes chordomas and chondrosarcomas; added to policy definitions in revision.

RelevanceAdded definition supports coverage language for skull-base indications where PBT is proven/medically necessary.

Central Nervous System Tumors (added definition)

Definition (added)Central Nervous System Tumors — tumors originating in the CNS (brain or spinal cord neoplasms).

ExamplesBrainstem glioma, craniopharyngioma, medulloblastoma, meningioma cited in definition.

Policy relevanceAdded as a proven indication when tumors are near critical structures and photon techniques cannot spare normal tissue.

Head and Neck Cancer (added definition)

Definition (added)Head and Neck Cancer — cancers originating in head and neck tissues (nasal cavity, sinuses, oral cavity, salivary glands, pharynx, larynx), typically squamous cell carcinoma.

Clinical noteAdded definition under policy to support expanded proven/medically necessary indications for select primary head & neck tumors.

Coverage linkageUsed to define when PBT can be considered for tumors near critical structures or with intracranial extension/perineural invasion.

Definitive Therapy (updated definition)

Updated definitionDefinitive Therapy — radiation treatments delivered with curative intent (updated definition in latest revision).

Policy useClarifies intent required for several proven indications (eg, primary CNS, head & neck, liver) included as definitive therapy scenarios.

Source referencesAligned with NCI and NCCN definitions cited in the policy document.

Proton beam radiation therapy (PBT) uses positively charged particles (protons) to deliver radiation with a distinct dose distribution characterized by minimal exit dose, allowing potentially improved sparing of surrounding normal tissues compared with photon (x‑ray) external beam RT. The document’s coverage recommendations reflect this dosimetric rationale and the varying strength of clinical evidence across indications.