ModifiedUnitedHealthcarePolicy CS105NJ.R

Proton Beam Radiation Therapy (for New Jersey Only)

Policy governing coverage and medical necessity criteria for proton beam radiation therapy (PBT/PBRT) for adults (19+) in New Jersey; pediatric (<19) PBT is covered without further review. Affects providers and members in New Jersey covered by UnitedHealthcare.

Policy Summary

PayerUnitedHealthcare

PolicyProton Beam Radiation Therapy (for New Jersey Only)

Policy CodePolicy CS105NJ.R

Change TypeMajor expansion of proven indications (head & neck, CNS, mediastinal) and new reirradiation criterion

Effective DateMay 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with documentation and a comparative PBT versus photon treatment plan demonstrating that photon techniques cannot achieve equivalent normal tissue sparing.

SourceLink

POLICY UPDATE CHANGES

Primary Head and Neck Cancers listed as a proven and medically necessary indication for definitive PBT when tumors are near critical anatomical structures and photon techniques cannot spare normal tissue.

Primary Central Nervous System Tumors listed as a proven and medically necessary indication for definitive PBT when tumors are near critical anatomical structures and photon techniques cannot spare normal tissue.

Primary mediastinal tumors included as proven/medically necessary indications (examples: thymomas, mediastinal lymphomas, thoracic sarcomas).

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

Expanded 'primary liver malignancies' to replace prior narrower HCC wording for curative-setting indications when photon techniques cannot spare normal tissue and other locoregional therapies are contraindicated or not feasible.

Exception request review criteria changed: replaced requirement to compare PBT, IMRT, and SBRT plans with requirement to compare PBT and photon-based radiation therapy (such as IMRT or SBRT) plans for the individual.

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

Clarified that benefit coverage is determined by federal, state, or contractual requirements and that medical record documentation may be required to assess clinical criteria but does not guarantee coverage.

Added definitions: Base of Skull Tumors, Central Nervous System Tumors, Head and Neck Cancer; updated definition of Definitive Therapy.

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

NJState

19Adult age cutoff

3Major new covered indications

5CPT/HCPCS codes removed

05/01/2026Most recent revision

Coverage Criteria and Medical Necessity

Proven/Covered Indications

Covered when ALL of the following conditions for the listed definitive/curative indications are met:

Base of Skull Tumors (Definitive Therapy): Proton beam radiation therapy is covered for base of skull tumors (for example, chordomas, chondrosarcomas, paranasal sinus, or nasopharyngeal tumors).

Primary Head and Neck Cancers (Definitive Therapy): Covered when tumors are near critical anatomical structures (such as the orbit, skull base, or cavernous sinus) or have intracranial extension or perineural invasion AND when documentation is provided that sparing of the surrounding normal tissue cannot be achieved with standard photon radiation therapy techniques.

Added 05/01/2026; chunk 136

Primary Central Nervous System Tumors (Definitive Therapy): Covered for primary CNS tumors (e.g., brain or spinal cord) when tumors are near critical anatomical structures (such as the optic nerve, brainstem, or spinal cord) AND when documentation is provided that sparing of the surrounding normal tissue cannot be achieved with standard photon radiation therapy techniques.

Added 05/01/2026; chunk 136

Intracranial Arteriovenous Malformations: Covered for intracranial arteriovenous malformations (AVMs).

Ocular Tumors (including intraocular/uveal melanoma): Covered for ocular tumors including intraocular/uveal melanoma (iris, ciliary body, choroid).

Requires experienced multidisciplinary team per NCCN/ASTRO guidance

Primary Liver Malignancies (Curative Setting): Covered for localized, unresectable primary liver malignancies (for example, hepatocellular carcinoma and intrahepatic cancer) in the curative setting when documentation is provided that sparing of the 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-only wording; chunk 137

Primary Mediastinal Tumors: Covered for primary mediastinal tumors (examples: thymomas, mediastinal lymphomas, thoracic sarcomas).

Added 05/01/2026; chunk 137

Reirradiation: Covered when the individual previously received radiation to the same specific anatomical site and now requires an additional course of radiation to that same site AND documentation is provided that sparing of the surrounding normal tissue cannot be achieved with standard photon radiation therapy techniques.

Added 05/01/2026; chunk 137

Equivalence and Unproven Indications

Exceptions, equivalence, and approach to diagnoses not listed as proven:

Prostate Cancer Equivalence: PBT and IMRT are considered clinically equivalent options for treating prostate cancer; principles of medically necessary services will be applied when selecting modality.

Unproven/Not Medically Necessary Indications: PBT is unproven and not medically necessary for treating indications not listed as proven due to insufficient evidence; however, PBT may be considered for diagnoses not listed as proven when BOTH of the following are provided: documentation that photon techniques cannot achieve equivalent normal tissue sparing AND a comparison of treatment plans for PBT and photon-based radiation therapy (such as IMRT or SBRT) for the specific individual.

Requires case-by-case review and documentation

Evidence-supported Indications / Guideline-supported scenarios

Evidence-supported and guideline-endorsed clinical scenarios (summary statements):

Skull Base Chordoma and Chondrosarcoma: Systematic reviews and technology assessments report PBT is widely used postoperatively with high local control in single-arm series; PBT may reduce certain long-term complications versus photons though randomized comparative data are limited.

Hayes assessment and meta-analyses cited

Select Head and Neck Cancer Sites: Guidelines (NCCN, ASTRO) and pooled observational data support consideration of PBT for oropharyngeal, nasopharyngeal, sinonasal, salivary gland, and other head & neck tumors when photon-based RT cannot meet normal tissue constraints; evidence shows favorable toxicity profiles and similar oncologic outcomes in observational studies.

Razavian et al. 2025 systematic review

Primary CNS Tumors and Spinal Tumors: Systematic reviews and practice parameters note PBT provides comparable survival to photons for diffuse gliomas and may reduce dose to uninvolved brain, potentially preserving neurocognitive function; PBT is recommended for selected patients when toxicity is a concern.

Covered with criteria — site-specific

Site-specific coverage considerations when evidence or guideline-based indications are met:

Intracranial AVMs: Single-fraction or multi-fraction PSRS may be used; selection should consider nidus size, location, prior interventions, and hemorrhage risk.

Single-fraction obliteration ~64.6% (median follow-up 35 months)

Ocular Tumors (Uveal/Choroidal Melanoma): PBT is an established definitive RT option with high local control and favorable survival outcomes in retrospective series and is recommended by guidelines when organ preservation is important; requires experienced multidisciplinary team.

ECRI analysis and NCCN/ASTRO support

Primary Liver Malignancies: PBT may be used for localized unresectable primary liver malignancies in the curative setting when photon techniques and transarterial options are not feasible or contraindicated; evidence includes systematic reviews and an RCT showing improved PFS and local control versus TACE.

Bush et al. 2023 RCT; ASTRO guidance

Appropriate Use / Selection Criteria

Appropriate use / selection — PBT or other advanced RT is appropriate when ALL relevant clinical factors favor benefit:

Selection for Mediastinal Lymphoma: Appropriate when mediastinal disease extends below the origin of the left main coronary artery and involves/abuts the left side of the heart OR in young female patients to substantially reduce breast dose OR in heavily pretreated individuals at increased risk for marrow/heart/lung toxicity.

ILROG guideline consensus

Thymomas/Thymic Carcinomas - Modality Escalation: Minimum technological requirement is 3D-CRT; escalation to IMRT/VMAT or PBT should be justified by documented need to spare critical organs (heart, lungs).

NCCN/ARS guidance

Reirradiation Appropriateness: Appropriateness must be individualized considering prior RT dose, extent of overlap, time since prior treatment, target proximity to critical organs, and performance status; selected patients may be considered for PBT when photon techniques cannot achieve acceptable sparing.

NCCN and reirradiation systematic review conclusions

Prostate Cancer — Evidence and Guideline Stance

Prostate cancer — evidence and guideline summary (informational):

Comparative Outcomes Evidence: Evidence is mixed: systematic reviews and database studies report PBT is relatively safe with promising control in many series, but comparative data do not consistently demonstrate superiority over IMRT or brachytherapy; some large observational analyses show no consistent advantage and mixed toxicity findings.

ECRI, Liu et al., Vapiwala et al., Hayes assessments

Guideline Position: AUA/ASTRO conditionally recommend PBT as an option but do not find it superior; NCCN considers both photon RT and proton therapy appropriate with comparable outcomes.

AUA/ASTRO and NCCN guideline summaries

Evidence summaries / coverage-relevant statements for selected indications

Evidence summaries and coverage-relevant statements for selected indications (informational):

Unproven Indications: For several indications (for example, neovascular age-related macular degeneration), quality evidence is limited and PBT/PBRT is considered unproven; randomized trials and long-term data are needed.

Evans et al.; AAO position

Bladder Cancer: PBT has been reported in small series and registries as part of bladder-preserving multimodality therapy with encouraging short-term outcomes, but data are limited and guideline endorsement is lacking; consider only within defined multimodality protocols or trials.

Araya et al.; Holzbeierlein et al.

Breast Cancer: Systematic reviews suggest PBT may reduce some toxicities and spare cardiac dose in early breast cancer, but evidence quality is low and no RCTs directly compare PBT with photons; evidence insufficient for broad coverage outside select anatomy-sparing scenarios or trials.

Holt et al. 2023

Guideline and evidence-based coverage considerations

Guideline- and evidence-based coverage considerations (site-specific):

Esophageal Cancer Guidance: NCCN states PBT is appropriate when OAR dose reduction is necessary and cannot be achieved by 3D-CRT; because data are evolving, NCCN recommends consideration in clinical trial settings.

Chunk 92

Preference for Photon IMRT Before PBT: STS/ASTRO and other guideline statements indicate IMRT is preferred over 3D-CRT for esophageal and many thoracic tumors and should be attempted when feasible; PBT is considered when photon techniques cannot meet OAR constraints.

Chunk 93

Lung Cancer Evidence Stance: For NSCLC, PBT shows dosimetric and some clinical promise (including hypofractionated regimens) but phase 3 randomized evidence is lacking; charged particle therapy for lung cancer is considered experimental until substantial phase 3 data are available.

Chunks 108 and 109

Site-specific evidence summaries (disease-site supporting evidence)

Site-specific evidence summaries (supporting statements used to inform coverage rationale):

Non–Small Cell Lung Cancer (NSCLC): Evidence consists mainly of non–phase 3 studies (primarily stage I); reported 2- to 5-year local control rates ranged 57%–87%. Authors conclude charged particle therapy should be considered experimental for lung cancer until substantial randomized data are available.

Pijls-Johannesma et al. 2010; ongoing RCT NCT01993810

Vestibular Schwannomas: Meta-analysis shows high overall tumor control (~95.4%) with PBRT but hearing preservation rates are limited (~40.6%) and no clear advantage over standard stereotactic radiosurgery demonstrated.

Santacroce et al. 2023

Pancreatic Cancer: Robust clinical evidence evaluating PBT for pancreatic adenocarcinoma is lacking; larger prospective studies are needed.

Chunk 111

Proven and Medically Necessary Indications for Definitive PBT

Newly added/clarified indications for definitive PBT — covered when ALL conditions listed are met:

Head and Neck Cancers - Definitive Therapy: Primary head and neck cancers (not already listed) when tumors are near critical anatomical structures such as the orbit, skull base, or cavernous sinus or have intracranial extension or perineural invasion AND when documentation is provided that sparing of surrounding normal tissue cannot be achieved with standard photon radiation therapy techniques.

Added 05/01/2026; chunk 136

Central Nervous System Tumors - Definitive Therapy: Primary CNS tumors (for example, brain or spinal cord) when tumors are near critical anatomical structures such as the optic nerve, brainstem, or spinal cord AND when documentation is provided that sparing of surrounding normal tissue cannot be achieved with standard photon radiation therapy techniques.

Added 05/01/2026; chunk 136

Primary Mediastinal Tumors: Primary mediastinal tumors (examples: thymomas, mediastinal lymphomas, thoracic sarcomas) are listed as proven/medically necessary indications.

Added 05/01/2026; chunk 137

Evaluation of Exception Requests

Evaluation of exception requests for diagnoses not explicitly listed as proven:

Plan Comparison Requirement: Exception requests must include a comparison of treatment plans for PBT and photon-based radiation therapy (such as IMRT or stereotactic body radiation therapy) that demonstrates the individual clinical need for proton modality (i.e., that photon techniques cannot achieve equivalent normal tissue sparing).

Revised requirement: compare PBT with photon-based plans (IMRT or SBRT) for the individual; chunk 137

Proton beam therapy (PBT) is unproven and not medically necessary for indications not listed as proven in this policy. Exceptions may be considered on a case‑by‑case basis only when both conditions are documented: (1) that equivalent normal tissue sparing cannot be achieved with standard photon radiation therapy techniques; and (2) a comparison of treatment plans for PBT and photon‑based radiation therapy (such as IMRT or stereotactic body radiation therapy) is provided.

Randomized trial evidence (ARUBA) for adults with unruptured intracranial arteriovenous malformations showed higher rates of death or dependency at 12 months with interventional treatment versus conservative management. This finding supports cautious selection for intervention in unruptured AVMs and implies that conservative management may be preferred unless clear individual‑level justification for treatment (including PBT/PSRS) is documented.

Evidence for ocular tumors treated with PBT is encouraging for local control and survival but is largely derived from retrospective case series and meta‑analyses. Given these limitations, additional prospective, comparative trials are needed to more definitively establish relative benefits and long‑term outcomes.

Use of particle beam radiation for indications listed under 'Unproven Indications' (for example, neovascular age‑related macular degeneration) is supported by limited and low‑quality evidence. Routine clinical use for these indications is not established and further randomized trials are required to demonstrate safety and efficacy.

The American Academy of Ophthalmology states that radiotherapy, including stereotactic techniques, is not considered a proven beneficial therapy for neovascular age‑related macular degeneration due to insufficient clinical evidence, indicating such indications lack support for routine PBT coverage.

For lung cancer, systematic reviews report encouraging but limited data from non‑randomized and phase‑II studies; authors conclude that charged particle therapy (including PBT) should be considered experimental until substantial randomized, comparative phase‑3 evidence is available.

No clinical evidence was identified supporting the combined delivery of PBT and IMRT within a single treatment plan. Claims that combine these modalities without supporting comparative evidence are not supported by the literature.

Coverage determinations remain subject to governing federal, state, or contractual benefit plan requirements. Documentation in the medical record showing clinical rationale and meeting policy criteria does not by itself guarantee benefit coverage; plan terms and applicable regulations govern final coverage decisions.

Reiterating policy position: PBT is unproven and not medically necessary for indications not explicitly listed as proven, except when exception criteria are met and appropriate comparative treatment planning and documentation are provided.

Interpretive note: many studies summarized in this policy are small, single‑arm series or retrospective cohorts without comparative data; these limitations restrict the ability to draw definitive conclusions about superiority of PBT versus photon‑based therapies.

Evidence for mediastinal lymphoma and other primary mediastinal tumors is limited mostly to case series. While dosimetric reductions to organs at risk have been demonstrated, the current evidence base does not support routine PBT for all mediastinal lymphoma patients without patient selection that demonstrates a clinically meaningful expected benefit.

Again, the use of PBT/PBRT for unproven indications such as neovascular AMD is not supported by high‑quality evidence. Systematic reviews and guideline statements emphasize uncertainty and call for randomized trials before routine adoption.

Absence of NCCN guideline discussion for certain gastrointestinal and gynecologic malignancies (for example, gastric, ovarian, uterine, vulvar cancers) limits guideline‑based support for PBT in these sites and may constrain coverage in the absence of stronger evidence or trial participation.

Restating the lung cancer evidence interpretation: until phase‑3 randomized or substantial comparative evidence is available, charged particle therapy for lung cancer should be considered experimental and not routinely covered outside of trials or well‑justified exceptions.

Specific conditions explicitly labeled 'not medically necessary' are not detailed in the provided excerpts. The recent revisions focus on additions to proven indications and on the criteria and documentation required to support coverage or exception reviews.

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Coverage requires indication‑specific criteria and documentation

Coverage of proton beam therapy (PBT) for adults (age ≥ 19) requires indication‑specific criteria and supporting documentation. PBT is covered for the proven indications listed in the policy; requests for diagnoses not explicitly listed must meet exception criteria and include documentation that photon techniques cannot meet organ-at-risk (OAR) constraints.

Coverage limited to adults (19+); individuals <19 covered without further review
Exceptions considered case‑by‑case only when documentation shows photon constraints cannot be met

Prior Authorization

Prior authorization required when photon constraints unmet; plan comparison required for exception reviews

Prior authorization is expected when PBT is proposed because photon-based techniques cannot achieve required normal tissue sparing. Prior authorization reviews for exception requests must include a direct comparison of treatment plans (PBT vs photon-based plan such as IMRT or SBRT) demonstrating the clinical benefit or meaningful OAR dose reduction with PBT.

Include comparative dosimetry (PBT and photon plan) in the submission

Procedure and Diagnosis Codes

Applicable 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 Diagnosis Codes (sample list)ICD-10

C11.0	Malignant neoplasm of superior wall of nasopharynx.
C22.0	Liver cell carcinoma.
C31.0	Malignant neoplasm of nasal cavity.
C31.1	Malignant neoplasm of maxillary sinus.
C31.2	Malignant neoplasm of frontal sinus.
C31.3	Malignant neoplasm of sphenoid sinus.
C31.8	Malignant neoplasm of overlapping sites of accessory sinuses.
C31.9	Malignant neoplasm of accessory sinus, unspecified.
C41.0	Malignant neoplasm of bones of skull and face.
C61	Malignant neoplasm of prostate.

1–10 of 15

1/2

Removed CPT/HCPCS Codesmixed

77385	Removed from Applicable Codes
77386	Removed from Applicable Codes
G6015	Removed from Applicable Codes
G6016	Removed from Applicable Codes
G6017	Removed from Applicable Codes

Reirradiation median dose (protons)

Reported median dose64.5 Gy (RBE 1.1)

ContextMedian reirradiation dose reported in a 2021 systematic review of charged particle reirradiation for skull base and head & neck tumors (26 studies, 1,118 individuals)

Associated outcomesTwo-year local control for proton reirradiation ranged 50%–86%; late grade ≥3 toxicities reported in up to 37% of individuals

Reirradiation median dose (carbon ions)

Reported median dose53.8 Gy (RBE 2.5-3.0)

Context

Background and Evidence Overview

Background: Proton beam therapy uses charged particles to deposit most of their energy at a finite depth (the Bragg peak), producing a more conformal dose distribution compared with photons. This dosimetric property can reduce dose to distal normal tissues and may be clinically advantageous for tumors adjacent to critical structures or in reirradiation scenarios; however, demonstrated clinical benefit over photon techniques varies by indication and evidence quality.

Definitions

Base of Skull Tumors — definition and examples

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

Common tumor typesExamples include chordomas and chondrosarcomas

Clinical relevanceThese tumors often involve critical endocrine, neurological, and vascular structures that may benefit from conformal modalities such as PBT

Central Nervous System Tumors — definition and examples

DefinitionTumors originating in the central nervous system (brain and spinal cord), including types such as brainstem glioma, craniopharyngioma, medulloblastoma, and meningioma

Clinical considerations

Policy Revision History

2026-05-01material_additions_and_revisionsLatest

Added primary Head and Neck cancers and primary Central Nervous System tumors as proven/medically necessary indications for definitive PBT when tumors are near critical structures and photon techniques cannot spare normal tissue; added primary mediastinal tumors and a reirradiation indication; broadened HCC wording to 'primary liver malignancies'; clarified exception plan-comparison requirement; removed several CPT/HCPCS codes; added medical record/documentation guidance; expanded definitions and updated Clinical Evidence/References sections.

2026-05-01coding_removal

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

Policy Summary

PayerUnitedHealthcare

PolicyProton Beam Radiation Therapy (for New Jersey Only)

Policy CodePolicy CS105NJ.R

Change TypeMajor expansion of proven indications (head & neck, CNS, mediastinal) and new reirradiation criterion

Effective DateMay 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with documentation and a comparative PBT versus photon treatment plan demonstrating that photon techniques cannot achieve equivalent normal tissue sparing.

SourceLink

On This Page

Goliot et al. 2024; NCCN/ACR-ARS guidance

Intracranial AVMs: PSRS and fractionated proton approaches can achieve meaningful nidus obliteration rates dependent on nidus volume and dose; single-fraction series reported ~64.6% obliteration with some hemorrhage risk and select patients require careful evaluation given ARUBA results for unruptured AVMs.

Hattangadi-Gluth et al. 2014; ARUBA considerations

Mediastinal Tumors and Lymphoma: PBT can substantially reduce dose to nearby organs (heart, breasts, lungs) and is appropriate in selected mediastinal cases where dosimetric benefit is clinically meaningful (for example, disease near the heart or young females to reduce breast dose).

ILROG and NCCN guidance

Thymic Tumors: PBT may be considered in select thymoma/thymic carcinoma patients when advanced techniques are needed to spare cardiac and pulmonary structures; 3D-CRT is the minimum technology and escalation to IMRT/VMAT/PBT should be justified.

NCCN/ARS recommendations

Esophageal Cancer: Meta-analyses and retrospective series show dosimetric benefits and reduced certain toxicities with PBT versus photons, with mixed survival impact; due to heterogeneity and low-quality evidence, PBT is best considered in select patients or clinical trials.

Zhou et al. 2023; Hayes assessments

Guideline Context: ACR and NCCN note PBT may spare normal tissues and can be appropriate when needed to deliver curative RT safely or limit toxicity, but emphasize need for more prospective comparative data.

Reirradiation is covered when the individual previously received radiation to the same anatomic site and documentation shows sparing of surrounding normal tissue cannot be achieved with standard photon techniques.

Added 05/01/2026; chunk 137

Primary Liver Malignancies - Curative Setting: Primary liver malignancies (such as hepatocellular carcinoma and intrahepatic cancer), localized unresectable, in the curative setting, are covered 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.

Replaced prior HCC-only wording; chunk 137

If photon constraints can be met, consider photon RT (e.g., IMRT/VMAT) first

Documentation Required

Require treatment at an experienced multidisciplinary center when indicated

For certain indications (for example, ocular tumors, complex head & neck, skull base, CNS tumors, and reirradiation), treatment should be delivered at an experienced multidisciplinary center with appropriate specialized personnel (ophthalmic oncologist, radiation oncologist, particle physicist) and infrastructure.

NCCN and ASTRO recommend experienced multidisciplinary teams for specific PBT indications
Documentation should identify the treating team's specialties and center experience

Prior Authorization

Muscle‑invasive bladder cancer — limited evidence; case‑by‑case review

PBT for muscle‑invasive bladder cancer is investigational/limited evidence. When proposed as part of multimodality bladder‑preserving therapy, requests should include multidisciplinary rationale, contemporaneous evidence, and detailed follow‑up plans; prior authorization may be required and decisions made case‑by‑case.

Available evidence is limited (small cohorts, short follow‑up); PBT not specifically endorsed in multidisciplinary bladder guidelines
Provide rationale for PBT over photon techniques and how PBT changes management or toxicity risk

Note

Use of PBT when clinically indicated; consider photon RT/IMRT first when feasible

Use PBT when clinically indicated to safely deliver curative radiation or to limit toxicity—particularly when photon techniques cannot meet dose constraints for critical structures. Whenever feasible, consider IMRT/advanced photon modalities prior to escalation to PBT unless documentation demonstrates inadequate photon sparing.

Consider IMRT/VMAT/VMAT or other advanced photon techniques before PBT for head & neck and other sites when they can meet constraints
ASTRO/NCCN guidance supports using photon RT first when adequate sparing is achievable

Prior Authorization

Plan comparison required for exception reviews

Plan comparisons are required for exception reviews and must be submitted as part of the authorization packet. Comparative plans should include dose–volume histograms and target/OAR doses for the PBT and the best-available photon plan (eg, IMRT or SBRT).

Comparative dosimetry (DVHs) mandatory for exceptions
Lack of plan comparison may result in denial

Prior Authorization

Plan‑specific prior authorization and decision tools

Check plan‑specific prior authorization rules and decision tools (for example, InterQual) before submitting requests. UnitedHealthcare may require use of third‑party decision support tools to assist in determination of medical necessity.

Verify federal, state, and contractual benefit requirements that may supersede this policy
Use the payer's prior‑authorization portal and required forms

Denial Risk

Medical record requirements and documentation insufficiency risk

Medical record documentation must fully support medical necessity. Insufficient or missing documentation in the patient record (history, exam, diagnostic studies, prior radiation details, and dosimetric comparisons) may lead to denial or noncoverage.

Required elements: relevant medical history, physical exam, imaging, pathology reports, prior treatment records
Missing documentation of attempted/considered photon plans or lack of dosimetric comparison increases denial risk

Documentation Required

Required clinical documentation elements (including reirradiation and ocular specifics)

Clinical documentation elements that should accompany a PBT request include: tumor histology and stage, target volumes, prior radiation (dates, doses, fields), proposed PBT prescription and fractionation, OAR dose constraints, and comparative photon plan details. For reirradiation, include prior dose distributions, extent of overlap, and time since prior treatment.

For ocular indications: baseline and follow‑up visual acuity, detailed ophthalmologic exams, RT dosages, and adverse event monitoring plans
For reirradiation: individualized planning details, prior radiation summaries, and proximity to critical organs

Denial Risk

Age‑Related Macular Degeneration — insufficient evidence

Age‑related macular degeneration (AMD): evidence is insufficient to support PBT/RT for neovascular AMD. Per AAO and systematic reviews, RT is not considered a proven beneficial therapy for AMD and further research is needed.

Do not cover PBT for AMD outside of a clinical trial given insufficient evidence
Provide trial identifiers or high‑quality evidence if proposing investigational use

Note

NCCN guidance — esophageal cancer and PBT

NCCN guidance for esophageal cancer: PBT may be appropriate when dose reduction to OARs cannot be achieved with photon techniques; because data are evolving, NCCN advises consideration of clinical trial enrollment and prioritizing IMRT when feasible.

If PBT is proposed for esophageal cancer, include rationale showing photon techniques cannot meet OAR constraints
Reference ongoing trials (eg, NCT03801876) where applicable

Billing Rule

Combined PBT and IMRT — no supporting evidence

There is no evidence to support combining PBT and IMRT in a single treatment plan. Requests proposing combined modalities should include justification; billing and claims should reflect that combined‑modality plans lack supportive evidence.

Do not submit a combined PBT+IMRT single‑plan approach without clear, compelling evidence
Separate course justification required if distinct sequential courses are proposed

Note

No other authorization triggers specified in this section; verify plan rules

No specific additional authorization triggers or step‑therapy requirements are specified in this excerpt beyond the stated prior authorization, documentation, and plan comparison expectations. Providers should verify plan‑level rules for any additional requirements.

Check for plan level step therapy or utilization management rules
This policy informs but does not replace plan contractual requirements

Note

Reference governing benefit requirements and instructions for use

Federal, state, and contractual benefit requirements govern coverage decisions and take precedence over this policy when conflicts exist. Before using this policy, verify applicable benefit terms; UnitedHealthcare reserves the right to modify policies and use decision tools to assist in administering benefits.

In event of conflict, federal/state/contractual requirements govern
Policy is informational and does not constitute medical advice

Median reirradiation dose reported for carbon ion therapy in the same 2021 systematic review of charged particle reirradiation

Chemotherapy useChemotherapy was used in 53% of proton cases and 18% of carbon ion cases in the review

BED threshold for hypofractionated PBT in early-stage NSCLC

BED threshold>= 105.6 Gy (RBE)

PopulationDerived from meta-analysis/systematic review of hypofractionated PBT for early-stage NSCLC (8 studies, 401 individuals)

Clinical relevanceHigher BED (>=105.6 Gy[RBE]) associated with improved outcomes (4-year OS 78% vs 56%) but higher late grade ≥2 toxicities (eg, rib fractures)

PBT is especially useful to minimize radiation exposure to healthy brain structures (brainstem, optic apparatus, hippocampus) when sparing is clinically important

Examples of benefitAllows safer dose escalation and reduced dose to adjacent organs (eyes, pituitary gland, cochleae) per ACR-ARS practice parameters

Medically Necessary Services — definition

DefinitionServices or supplies necessary to prevent, evaluate, diagnose, correct, treat, or prevent deterioration of an illness or condition, consistent with standards of good medical practice and generally accepted by the medical community

ScopeIncludes services intended to maintain or restore maximal functional capacity and excludes experimental services

Documentation basisMedically necessary services must be supported by peer-reviewed publications and accepted clinical opinion

Definitive Therapy — definition (curative intent)

DefinitionRadiation treatments delivered with curative intent

IntentAimed at eliminating disease and achieving full recovery while maintaining quality of life (NCI/NCCN definitions)

ApplicationUsed for definitive management of tumors when curative outcomes are the goal

Proton Beam Therapy (PBT) — definition and Bragg peak concept

DefinitionA highly conformal external beam radiation modality in which protons deposit most of their energy at a finite depth (Bragg peak), allowing dose sparing of distal normal tissues compared with photons

Key conceptBragg peak: protons stop abruptly at a defined depth, concentrating dose within the target while reducing exit dose to surrounding tissues

Clinical implicationEnables dose escalation or OAR sparing in anatomically complex or critical locations

Proton Stereotactic Radiosurgery (PSRS) — definition and use for intracranial lesions

DefinitionSingle- or multi-fraction highly conformal proton stereotactic radiosurgery used for intracranial lesions such as AVMs

PurposeAims for nidus obliteration with precise high-dose delivery (example: single-fraction PSRS median dose often ~15 Gy)

OutcomesSingle-fraction PSRS series reported ~64.6% obliteration at median 35-month follow-up with a 5-year cumulative obliteration incidence of 70%

Particle beam therapy (PBT) — general definition

DefinitionRadiation therapy using charged particles (protons or heavier ions) that can reduce dose to surrounding tissues compared with photon-based RT

ExamplesIncludes proton beam therapy (PBT), carbon ion therapy, and other charged-particle modalities

Clinical roleUsed when tissue sparing is clinically important or when dosimetric advantages over photons are expected

Organ at risk (OAR) — critical normal tissues definition

DefinitionCritical normal tissues adjacent to the radiation target that are prioritized for dose reduction (examples: heart, lungs, breast, spinal cord, optic apparatus)

ImportanceDose to OARs drives modality selection and justification for advanced techniques such as PBT when photon-based approaches cannot meet constraints

Guideline noteNCCN and specialty guidelines emphasize sparing OARs to reduce long-term toxicity, supporting use of advanced RT modalities when beneficial

Relative biological effectiveness (RBE) — factor used with charged particles

DefinitionA factor used to account for differences in biological effectiveness between charged particles and reference photon beams when reporting dose (example RBE values cited in reirradiation review)

Example valuesProton RBE commonly approximated as 1.1; carbon ion RBE cited as ~2.5–3.0 in reirradiation series

Dosimetric useApplied to convert physical dose into Gy(RBE) for clinical reporting and comparison

Cobalt Gray Equivalent (CGE) — dosimetric unit used in ocular PBT trials

DefinitionCobalt Gray Equivalent (CGE) — a dosimetric unit used historically in proton therapy reporting and cited in ocular PBT trials (eg, 16-CGE vs 24-CGE)

UsageUsed in some randomized trials for ocular indications to report fractionated proton doses

Clinical noteCGE is equivalent to Gy(RBE) for comparative reporting in those trial contexts

Hypofractionated PBT — definition (>= 3 Gy[RBE] per fraction)

DefinitionHypofractionated PBT refers to PBT schedules delivering >= 3 Gy (RBE) per fraction

ContextUsed in reported studies for early-stage NSCLC where BED thresholds were analyzed

Threshold implicationBED calculations and thresholds (eg, >=105.6 Gy[RBE]) are applied to compare outcomes across hypofractionated regimens

Biologically Effective Dose (BED) — explanation and relevance to pooled analyses

DefinitionBiologically effective dose (BED) is a cumulative dose metric (reported as Gy[RBE]) that accounts for total dose and fractionation to estimate biological effect

RelevanceBED was used in pooled analyses of hypofractionated PBT for early-stage NSCLC; a BED >= 105.6 Gy(RBE) was associated with improved survival and local control

Clinical trade-offHigher BED may improve tumor control but is associated with increased late toxicity (eg, rib fractures)

Particle beam therapy (PBT/PBRT/C-ion) — alternate terminology definitions

Alternate termsParticle beam therapy may be referred to as PBT, PBRT, or C-ion depending on the charged particle used

ExamplesPBT typically denotes protons; C-ion denotes carbon ion therapy with higher RBE

Clinical noteTerminology varies across studies and guidelines; dose reporting should specify particle type and RBE/CGE conversion

Base of Skull Tumors — definition added in revision

Definition addedBase of Skull Tumors definition was added to the policy during the 05/01/2026 revision

SourcePolicy revision notes clarifying added definitions and criteria

ImplicationInclusion formalizes skull base tumor examples (eg, chordoma, chondrosarcoma) as proven indications when criteria met

Central Nervous System Tumors — definition added in revision

Definition addedCentral Nervous System Tumors definition was added to the policy during the 05/01/2026 revision

ScopeCNS tumors include brain and spinal cord neoplasms where proximity to critical structures may justify PBT

Policy impactAddition supports listing primary CNS tumors as proven/medically necessary indications when photon sparing cannot be achieved

Head and Neck Cancer — definition added in revision

Definition addedHead and Neck Cancer definition was added to the policy during the 05/01/2026 revision

ExamplesIncludes cancers of nasal cavity, sinuses, oral cavity, salivary glands, pharynx, and larynx—often squamous cell histology

Clinical relevanceAddition supports coverage language specifying head & neck primary cancers near critical anatomy as proven indications when photon sparing not achievable

Definitive Therapy — definition updated in revision

Updated definitionDefinitive Therapy defined/updated as radiation treatments delivered with curative intent; policy revision clarified curative-intent criteria

Source referencesDefined per NCCN and NCI references cited in policy (NCCN 2025; NCI 2025)

Coverage implicationUsed to frame proven/medically necessary indications for definitive PBT added in the 05/01/2026 revision

Added definitions for Base of Skull Tumors, Central Nervous System Tumors, and Head and Neck Cancer and updated the definition of 'Definitive Therapy'.

2026-05-01procedure_for_exceptions_revised

Revised exception-evaluation requirement to require comparison of PBT and photon-based radiation therapy (such as IMRT or SBRT) plans for the individual, replacing prior requirement to compare PBT, IMRT, and SBRT plans.

2026-05-01documentation_guidance_added

Added medical records documentation language clarifying that benefit coverage is determined by federal, state, or contractual requirements and that medical-record documentation may be required to assess clinical criteria but does not guarantee coverage.

Administrative/documentation guidance in the May 1, 2026 revisions emphasizes that benefit coverage is determined by applicable federal, state, or contractual requirements and that related‑policy link references were removed from the policy. The update also clarified exception review requirements and added documentation expectations; these administrative clarifications do not by themselves change clinical coverage criteria.