Proton Beam Radiation Therapy (for Pennsylvania Only)

Coverage Summary

This UnitedHealthcare (Pennsylvania) medical policy CS105PA.T (effective August 1, 2025) defines coverage for proton beam radiation therapy (PBT/PBRT) for individuals aged ≥21 under the standard criteria and states that PBT is covered without further review for individuals <21.

Coverage stance is mixed: the policy lists 4 proven / medically necessary definitive indications (base of skull tumors, localized unresectable hepatocellular carcinoma in the curative setting when standard techniques cannot achieve normal tissue sparing, intracranial arteriovenous malformations, and ocular tumors) while designating all other indications as unproven / not medically necessary except when documented case-by-case exceptions are met (including an individualized comparison of PBT, IMRT, and SBRT treatment plans).

Headline statistics in the policy note 4 proven indications listed, state-specific application to Pennsylvania, and an age cutoff of 21 years for standard criteria; the policy also documents multiple guideline and evidence updates (references updated through 2025) and emphasizes variable evidence quality across indications (dosimetric benefits are consistent but clinical outcomes are often low-to-very-low quality evidence).

Key policy stats and revisions

Proven Indications Listed4

Age cutoff for standard criteria21 years

State-specific PolicyPennsylvania only

Material revisions (effective date)2025-08-01

Quality of evidence (summary)Multiple sources cited; low-to-very-low for select indications

Consistent findingDosimetric benefit (reduced dose to OARs) consistently reported

Medical-Necessity Criteria

Prostate Cancer

Coverage stance and application guidance for prostate cancer:

Prostate Cancer - guidance: PBT and IMRT are proven and considered clinically equivalent for treating prostate cancer; as a result, principles of medical necessity will be applied.

Coverage Implications & Guideline Positions

The policy summarizes a list of Unproven Indications where quality evidence is limited and further robust randomized controlled trials (RCTs) with long-term outcomes are warranted.

Select indications highlighted as having limited or uncertain evidence (and thus needing RCTs / higher-quality data) include: age-related macular degeneration (AMD) (evidence uncertain and AAO does not recommend RT), prostate cancer (comparative effectiveness vs IMRT not established; guideline panels consider PBT an option but not proven superior), muscle-invasive bladder cancer (small registry and single-institution series with limited follow-up), brain and spinal cord tumors / diffuse gliomas (mostly nonrandomized/retrospective data suggesting dosimetric benefits), breast cancer (low-quality evidence suggesting reduced cardiac dose/adverse events but no RCTs), choroidal hemangiomas (comparative data suggest equivalence for ≤3 mm, PBT may be preferable for >3 mm), and esophageal cancer (meta-analyses show reduced OAR dose and possible toxicity/OS benefits but evidence is heterogeneous and low quality).

Provider Actions & Authorization Requirements

Prior Authorization

Prior Authorization Recommended

Prior authorization is recommended for proton beam therapy (PBT) requests. Submit a complete prior authorization request with supporting clinical documentation, including diagnosis, stage, treatment intent, and rationale for PBT over standard photon techniques. Include treatment-plan comparisons and any available comparative evidence to support medical necessity.

A prior authorization request should include the individualized treatment plan comparison (PBT vs. IMRT and/or SBRT) when applicable.
For hepatocellular carcinoma (HCC) exception requests, include documentation that sparing cannot be achieved with standard techniques and that transarterial therapies are contraindicated or not feasible.

Documentation Required

Exception Evaluation — Non‑Proven Indications

Requests for indications that are not listed as proven in this policy (including many adult solid tumors beyond the proven list) will be evaluated on a case‑by‑case basis. Clinical justification must be provided showing why PBT is expected to provide a meaningful clinical benefit compared with standard photon techniques for the individual member.

Coding

Proton treatment delivery CPT codes (relevant to PBT services)CPT

77520	Proton treatment delivery; simple, without compensation.
77522	Proton treatment delivery; simple, with compensation.
77523	Proton treatment delivery; intermediate.
77525	Proton treatment delivery; complex.

Radiation planning / delivery and guidance CPT codes (may be used with PBT or photon RT)CPT

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.
77385	Intensity modulated radiation treatment delivery (IMRT), includes guidance and tracking, when performed; simple.
77386	Intensity modulated radiation treatment delivery (IMRT), includes guidance and tracking, when performed; complex.
77387	Guidance for localization of target volume for delivery of radiation treatment, includes intrafraction tracking, when performed.

Medicare G-codes for advanced delivery/compensation/tracking (applicable technology codes)CPT

G6015	Intensity modulated treatment delivery, single or multiple fields/arcs, via narrow spatially and temporally modulated beams, binary, dynamic MLC, per treatment session.
G6016	Compensator-based beam modulation treatment delivery of inverse planned treatment using three or more high resolution (milled or cast) compensator, convergent beam modulated fields, per treatment session.
G6017	Intra-fraction localization and tracking of target or patient motion during delivery of radiation therapy (e.g., 3D positional tracking, gating, 3D surface tracking), each fraction of treatment.

ICD-10-CM diagnosis codes referenced (tumor & AVM indications)ICD-10

C11.*	Malignant neoplasm of nasopharynx (C11.0-C11.9 and overlapping sites).
C22.0	Liver cell carcinoma (hepatocellular carcinoma).
C30.0	Malignant neoplasm of nasal cavity.
C31.*	Malignant neoplasm of accessory sinuses (maxillary, ethmoidal, frontal, sphenoid, overlapping sites).
C41.0	Malignant neoplasm of bones of skull and face.
C61	Malignant neoplasm of prostate.
C69.*	Malignant neoplasm of eye and adnexa (conjunctiva, cornea, retina, choroid, ciliary body, lacrimal gland, orbit, overlapping sites).
D09.20	Carcinoma in situ of unspecified eye.
D14.0	Benign neoplasm of middle ear, nasal cavity and accessory sinuses.
D16.4	Benign neoplasm of bones of skull and face.

1–10 of 13

1/2

Added/Removed ICD-10 diagnosis codes (policy history)ICD-10

C61	Malignant neoplasm of prostate (added).
C61.0	Malignant neoplasm of central zone of prostate (removed).

Background & Evidence Summary

Proton beam radiation therapy (PBT) is a charged-particle RT modality that delivers dose with greater conformality and reduced exit dose compared with photon external-beam RT, aiming to spare surrounding normal tissues while treating the target.

The policy notes that evidence for clinical benefit varies by indication: there is relatively stronger support for use in skull base tumors (e.g., chordomas and chondrosarcomas), ocular tumors (uveal/intraocular melanoma), hepatocellular carcinoma (HCC) in selected curative settings, and intracranial arteriovenous malformations (AVMs), while the benefit is unclear for many other adult solid tumors (numerous adult solid tumor sites have dosimetric advantages but limited high-quality outcome data).

Evidence Source / Topic	Takeaway
Systematic reviews / meta-analyses
Multiple systematic reviews/meta-analyses cited across indications (e.g., Nie 2022; Cochrane El Sayed 2021; Bae 2024; Zhou 2023) — generally show dosimetric advantages and favorable local control for select tumors but note heterogeneity and limited RCT data; recommend further high-quality trials.
RCT evidence
Randomized data are limited. Selected RCTs referenced include ARUBA (AVM) and a single RCT for HCC (Bush 2016) with mixed outcomes; many indications lack phase III randomized comparisons.
Prostate (selected studies/guidelines)
Multiple comparative and single-arm studies (Santos 2019; Henderson 2017; Bryant 2016; Yu 2013; Hayes assessment) show dosimetric advantages for PBT but no consistent superiority in clinical toxicity or outcomes vs IMRT; AUA/ASTRO (2022) conditionally recommend PBT as an option and NCCN considers it a reasonable alternative.
Age-Related Macular Degeneration (AMD)
Systematic reviews (Evans 2020; Cochrane) and an RCT (Zambarakji 2006) found uncertain or no benefit and potential visual loss; AAO does not recommend RT for AMD.
Bladder cancer
Small registry and retrospective series (Araya 2023; Takaoka 2017; Miyanaga 2000) report promising short-term OS/LC and acceptable toxicity but are limited by small size and follow-up; evidence insufficient for definitive conclusions.
Brain / AVM and diffuse gliomas
For intracranial AVMs, systematic reviews and series (ARUBA trial context; Hattangadi-Gluth 2014) show high obliteration rates with proton stereotactic approaches but RCT evidence limited and ARUBA favored conservative management for unruptured AVMs; for adult diffuse gliomas, systematic review (Goliot 2024) suggests comparable survival and potential toxicity-sparing but evidence largely retrospective.
Breast cancer
Systematic review/meta-analysis (Holt 2023) of 32 studies (n~1452) suggests PBT may reduce some adverse events and cardiac dose but evidence is low quality and no RCTs demonstrate superiority; Hayes assessment rates evidence low.
Choroidal hemangioma
Retrospective multicenter comparison (Mathis 2021) found similar visual outcomes for tumors ≤3 mm (PDT vs PBT); PBT may be preferable for tumors >3 mm.
Esophageal cancer
Meta-analysis (Zhou 2023) and Hayes assessments indicate PBT reduces OAR dose and may lower some toxicities and improve OS in subgroup analyses, but evidence is heterogeneous and low quality; NCCN recommends PBT when OAR dose reduction is needed and suggests clinical-trial enrollment.
Reference / counts and guideline summaries
Numerous peer-reviewed studies and guideline citations updated through 2025 (multiple systematic reviews, technology assessments, and guideline statements summarized in policy).

Revised Coverage Rationale (Summary of Change)

2025-08-01material revisionLatest

Revised coverage criteria: replaced requirement to compare 'Definitive Therapy' plans with requirement to include a comparison of individualized treatment plans for PBT, IMRT, and SBRT for the specific individual; removed the prior example list of unproven/not medically necessary indications.

2025-08-01code addition

Added ICD-10 diagnosis code C61 to Applicable Codes.

2025-08-01code removal

Revision History

2025-08-01revisedLatest

Revised coverage criteria for PBT for diagnoses not listed as proven: replaced the prior wording requiring a comparison of 'Definitive Therapy' plans with a requirement that evaluation include a comparison of treatment plans for PBT, IMRT, and SBRT for the specific individual; removed the enumerated example list of unproven/not medically necessary indications.

2025-08-01added code

Added ICD-10 diagnosis code C61 to the Applicable Codes list.

2025-08-01removed code