CurrentRegencePolicy 49

Charged-Particle (Proton) Radiotherapy

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This policy governs medical-necessity evaluation and documentation requirements for charged-particle irradiation, primarily proton beam therapy, for definitive, adjuvant, or salvage treatment of primary or metastatic tumors.

Policy Summary

PayerRegence

PolicyCharged-Particle (Proton) Radiotherapy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateOctober 1, 2026

Last ReviewAug 1, 2026

Next Review DateJune 1, 2027

Key ActionSubmit the required clinical documentation for review to determine whether the charged-particle radiotherapy policy criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

CurrentRegencePolicy 49

Charged-Particle (Proton) Radiotherapy

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Policy Summary

PayerRegence

PolicyCharged-Particle (Proton) Radiotherapy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateOctober 1, 2026

Last ReviewAug 1, 2026

Next Review DateJune 1, 2027

Key ActionSubmit the required clinical documentation for review to determine whether the charged-particle radiotherapy policy criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3Covered or potentially covered clinical contexts

InvestigationalDefault stance outside qualifying criteria

10 mmCNS proximity threshold

No more costly than IMRTProstate cost condition

5Maximum SBRT treatment-course fractions

Medical Necessity and Covered Indications

Adult primary or metastatic tumor indications

Charged-particle irradiation, including proton beam therapy, may be considered medically necessary for specified primary or metastatic tumors when used for definitive, adjuvant, or salvage treatment.

Adult tumor pathway

Listed adult tumor indications
- Ocular tumor: The tumor is an intraocular or uveal melanoma, including melanoma of the iris, choroid, or ciliary body.
- Central nervous system tumor: The tumor is one of the central nervous system tumors specified in the policy.

Adult CNS proximity and dose limitation

When the adult CNS proximity pathway applies, both the dose-response and anatomic dose-limitation requirements must be established.

Adult CNS proximity and dose-limitation pathway

Dose-response condition: Evidence shows that local tumor response depends on the dose of radiation delivered.
Anatomic dose limitation: Delivery of an adequate radiation dose to the tumor is limited by the proximity of vital radiosensitive tissues or structures.

Ocular tumors

Charged-particle irradiation may be considered medically necessary for ocular tumors when applicable policy criteria are met.

Qualifying ocular tumor: The patient has an ocular tumor, including an intraocular or uveal melanoma, and the applicable policy criteria are met.

Central nervous system tumors

Charged-particle irradiation may be considered medically necessary for a CNS tumor meeting at least one qualifying clinical context.

Qualifying CNS tumor context

Skull-base or cervical spinal cord tumor: The tumor is a cervical spinal cord tumor or a central nervous system tumor invading the base of the skull, and applicable policy criteria are met.
Tumor adjacent to critical structure: The tumor extends to within 10 mm or less of the optic chiasm, brainstem, or cervical spinal cord at or above the foramen magnum, and applicable policy criteria are met.Within 10 mm or less

Prior radiation

Charged-particle irradiation may be considered medically necessary for selected reirradiation cases when the applicable tumor criteria are also met.

Head and neck or CNS reirradiation: The patient has a head and neck tumor or central nervous system tumor, has received prior radiation in the expected treatment field, and applicable policy criteria are met.Prior radiation in the expected treatment field

Pediatric tumors

Charged-particle irradiation may be considered medically necessary for pediatric central nervous system and malignant solid tumors when applicable policy criteria are met.

Pediatric CNS or malignant solid tumor: The patient has a pediatric central nervous system tumor or pediatric malignant solid tumor and applicable policy criteria are met.

Local or locally advanced prostate cancer

Proton therapy for local or locally advanced prostate cancer is generally not medically necessary, but may be considered medically necessary when the cost condition is satisfied.

Local or locally advanced prostate cancer with cost parity

Qualifying stage: The disease is clinical or pathological T1 or T2, N0, M0, or clinical or pathological T3 or T4, N0 or N1, M0.T1-T2, N0, M0, or T3-T4, N0-N1, M0
Cost condition: The requested specific course of proton therapy will be no more costly than IMRT photon irradiation or another irradiation approach.

Investigational or nonqualifying indications

The following indications are considered investigational.

Investigational indications

Nonqualifying CNS tumor: The CNS tumor does not meet the specified skull-base, cervical-spinal-cord, or critical-structure proximity criteria.
Other pediatric tumor: The pediatric tumor is not a central nervous system tumor or malignant solid tumor meeting policy criteria.
Regional or metastatic prostate cancer: The prostate cancer is regional (locally advanced) or metastatic.
Other tumor or indication: The tumor or indication is not otherwise addressed by qualifying policy criteria.

Local or locally advanced prostate cancer — qualifying cost and clinical conditions

Proton beam therapy for local or locally advanced prostate cancer is generally not medically necessary, but may be considered medically necessary when both conditions are met.

Qualifying prostate cancer stage and cost condition

Qualifying stage: The individual has local prostate cancer defined as clinical or pathological T1 or T2, N0, M0, or locally advanced prostate cancer defined as clinical or pathological T3 or T4, N0 or N1, M0.T1-T2, N0, M0, or T3-T4, N0-N1, M0
Cost comparability: The requested specific course of proton beam therapy will be no more costly than IMRT photon irradiation or another irradiation approach.No more costly than IMRT photon irradiation or another irradiation approach

Regional or metastatic prostate cancer

Proton beam therapy is investigational for regional (locally advanced) or metastatic prostate cancer.

Insufficient evidence: The prostate cancer is regional (locally advanced) or metastatic, and there is not enough research to show improved health outcomes with charged-particle irradiation.

Other tumors or indications

All other tumors or indications are investigational when policy criteria are not met.

No qualifying policy criteria: The tumor or indication is not otherwise supported by policy criteria, and there is not enough research to show improved health outcomes with charged-particle irradiation compared with other radiotherapy techniques.

SRS or SBRT/SABR

Proton beam therapy used for SRS or SBRT/SABR is investigational.

Stereotactic treatment application: Charged-particle irradiation is being used for stereotactic radiosurgery, stereotactic body radiotherapy, or stereotactic ablative radiotherapy.SRS, SBRT, or SABR

Charged-particle irradiation, including proton beam therapy, is considered not medically necessary for local or locally advanced prostate cancer, including clinical or pathological T1-T2, N0, M0 disease or T3-T4, N0-N1, M0 disease, because outcomes are comparable but not superior to other irradiation approaches. Coverage may be considered when the requested specific course meets the applicable medical-necessity requirements.

For local or locally advanced prostate cancer, proton beam therapy is generally significantly more costly than other irradiation approaches. The requested course is considered not medically necessary when it is more costly than IMRT photon irradiation or another irradiation approach.

Proton therapy has demonstrated comparable, but not superior, clinical outcomes compared with approaches such as intensity-modulated radiotherapy (IMRT) photon irradiation. Because the clinical benefit is not superior and the treatment is generally more costly, proton therapy may be considered medically necessary only when the requested specific course is no more costly than IMRT photon irradiation or another irradiation approach.

Charged-particle irradiation with proton beam is considered not medically necessary for local or locally advanced prostate cancer when the requested specific course is more costly than IMRT photon irradiation or another irradiation approach. Proton therapy for regional or metastatic prostate cancer is considered investigational because there is not enough research to show improved health outcomes.

Coding and Billing Guidance

Planning and related radiation therapy codesCPT

77399	Unlisted procedure, medical radiation physics, dosimetry and treatment devices, and special services
77301	Intensity modulated radiotherapy plan, including dose volume histograms for target and critical structure partial tolerance specification
77338	Multi-leaf collimator (MLC) device(s) for intensity modulated radiation therapy (IMRT), design and construction per IMRT plan
77402-77416	Nonspecific radiation therapy treatment delivery CPT codes for photon treatment, based on the voltage of the energy source

Stereotactic radiation therapy codesCPT

32701	Thoracic target(s) delineation for stereotactic body radiation therapy (SRS/SBRT), (photon or particle beam), entire course of treatment
77299	(SRS/SBRT), (photon or particle beam), entire course of treatment; unlisted procedure, therapeutic radiology clinical treatment planning
77301	Intensity modulated radiotherapy plan, including dose volume histograms for target and critical structure partial tolerance specification
77372	Radiation therapy delivery, stereotactic radiosurgery (SRS), complete course of treatment of cranial lesion(s) consisting of 1 session; multi-source Cobalt 60 based
77373	Stereotactic body radiation therapy, treatment delivery, per fraction to 1 or more lesions, including image guidance, entire course not to exceed 5 fractions

Treatment deliveryCPT

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

Clinical treatment managementCPT

77432	Stereotactic radiation treatment management of cerebral lesion(s), complete course of treatment consisting of one session
61796	Stereotactic radiosurgery (particle beam, gamma ray, or linear accelerator); 1 simple cranial lesion
61797	Stereotactic radiosurgery (particle beam, gamma ray, or linear accelerator); each additional cranial lesion, simple
61798	Stereotactic radiosurgery (particle beam, gamma ray, or linear accelerator); 1 complex cranial lesion
61799	Stereotactic radiosurgery (particle beam, gamma ray, or linear accelerator); each additional cranial lesion, complex
61800	Application of stereotactic headframe for stereotactic radiosurgery
63620	Stereotactic radiosurgery (particle beam, gamma ray, or linear accelerator); 1 spinal lesion
63621	Stereotactic radiosurgery (particle beam, gamma ray, or linear accelerator); each additional spinal lesion

Clinical treatment managementHCPCS

G0339	Image guided robotic linear accelerator-based stereotactic radiosurgery, complete course of therapy in one session, or first session of fractionated treatment
G0340	Image guided robotic linear accelerator-based stereotactic radiosurgery, delivery including collimator changes and custom plugging, fractionated treatment, all lesions, per session, second through fifth sessions, maximum five

Distance from critical CNS structures

Proximity thresholdWithin 10 mm or less of a critical CNS structure

Critical structuresOptic chiasm, brainstem, or cervical spinal cord

Anatomic levelCervical spinal cord at or above the foramen magnum

Local or locally advanced prostate cancer staging

Local prostate cancerClinical or pathological T1 or T2, N0, M0

Locally advanced prostate cancer

Documentation and Review Requirements

Documentation Required

Submit Clinical Documentation for Review

Submit the required clinical documentation for review so the plan can be evaluated against the applicable policy criteria.

Documentation Required

Demonstrate Applicable Medical-Necessity Criteria

Demonstrate the medical-necessity pathway that applies to the requested proton therapy. Documentation must establish that the applicable tumor type, treatment context, and policy criteria are met.

Applicable pathways include ocular tumors; qualifying central nervous system tumors; head and neck or central nervous system reirradiation; pediatric central nervous system or malignant solid tumors; and qualifying local or locally advanced prostate cancer.

Documentation Required

Documentation for All Tumors

Clinical and Technical Background

Charged-particle radiation therapy includes proton beam therapy, carbon ion irradiation, and helium ion irradiation. Because helium and carbon ion therapy are not currently available in the United States, this policy primarily addresses proton beam therapy. Charged particles deposit ionizing energy at a defined tissue depth, known as the Bragg Peak, which can reduce exposure to surrounding normal tissue. The policy describes potential use when conventional treatment cannot provide adequate local control or tumor dose because of nearby radiosensitive structures; however, cited evidence reviews generally report low or poor-quality evidence.

Policy Definitions

Head and neck cancers

Oral and pharyngeal sitesOral cavity and lip, hypopharynx, oropharynx, and nasopharynx

Other anatomic sitesLarynx, paranasal sinuses and nasal cavity, and salivary glands

Additional tumor typesSoft-tissue sarcomas, unusual histologies, or occult primaries in the head and neck region

Bragg Peak

DefinitionA charged-particle dose-distribution characteristic

Energy depositionIonizing energy is deposited at a precise tissue depth

Normal-tissue effect

Policy Summary

PayerRegence

PolicyCharged-Particle (Proton) Radiotherapy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateOctober 1, 2026

Last ReviewAug 1, 2026

Next Review DateJune 1, 2027

Key ActionSubmit the required clinical documentation for review to determine whether the charged-particle radiotherapy policy criteria are met.

SourceLink

On This Page

Clinical or pathological T3 or T4, N0 or N1, M0

Staging categoriesClinical or pathological T1–T4; N0–N1; M0

Maximum SBRT treatment-course fractions

Maximum course lengthThe entire SBRT treatment course must not exceed 5 fractions

Delivery basisTreatment delivery is reported per fraction

Applicable treatmentStereotactic body radiation therapy (SBRT), including photon or particle-beam treatment

For all tumors, provide complete clinical documentation supporting the diagnosis and treatment request.

History and physical chart notes, including the specific diagnosis and pertinent imaging results.
Documentation of prior radiation to the treatment volume, when relevant.

Documentation Required

Document Adult CNS Tumor Proximity

For an adult central nervous system tumor when the proximity pathway applies, submit documentation establishing the tumor’s proximity to critical structures.

Include the formal diagnostic radiology report.
State the exact distance from the tumor to the optic chiasm, brainstem, or cervical spinal cord at or above the foramen magnum.
The exact distance must appear in the formal radiology report or in physician documentation in the member’s clinical record.

Documentation Required

Document Adult CNS Dose Limitation

For an adult central nervous system tumor, document that adequate tumor dosing is clinically needed but limited by nearby radiosensitive tissue.

Provide evidence that local tumor response depends on the radiation dose delivered.
Document that proximity to vital radiosensitive tissues or structures limits delivery of an adequate dose.

Documentation Required

Provide Prostate Cost Attestation

When Criterion II applies to prostate cancer, attest that the proposed proton therapy will not cost more than IMRT or another irradiation approach.

Provider attestation is required.
Compare the specific proposed course of therapy with IMRT or another applicable irradiation approach.

Billing Rule

Include Image Fusion in Treatment Planning

Include image fusion within treatment planning when it is performed to improve delineation of the target and normal critical structures.

Use CPT 77399 for image fusion.
CPT 77399 is considered part of treatment planning.

Denial Risk

Investigational or Cosmetic Services

Investigational or cosmetic services are excluded from coverage under the contract, and members may be financially responsible for these services.

Inform the member before rendering services that are considered investigational or cosmetic and may result in member liability.

Denial Risk

Missing Required Documentation

Required documentation must be submitted for review. Missing information may affect the review and the coverage decision.

Incomplete documentation can prevent confirmation that policy criteria are met.
The review outcome may be affected when required records are not provided.

Denial Risk

Nonqualifying CNS Tumor

Proton therapy for an adult central nervous system tumor that does not meet the qualifying criteria is considered investigational.

This includes CNS tumors that do not meet the applicable location, proximity, or other policy criteria.

Denial Risk

Other Pediatric Tumor Indication

Proton therapy for pediatric tumors other than pediatric central nervous system or malignant solid tumors, or when applicable criteria are not met, is considered investigational.

Denial Risk

Regional or Metastatic Prostate Cancer

Proton therapy for regional or metastatic prostate cancer is considered investigational because research has not demonstrated improved health outcomes compared with other radiotherapy techniques.

Denial Risk

Other Tumor or Indication

For all other tumors or indications that do not meet the policy criteria, proton therapy is considered investigational.

Documentation Required

Compare Prostate Therapy Costs

For qualifying local or locally advanced prostate cancer, compare the specific proposed proton therapy course with IMRT or another irradiation approach.

The cost comparison must address whether the requested course is no more costly than the comparator therapy.

Denial Risk

Prostate Therapy Exceeds Comparator Cost

Proton therapy for local or locally advanced prostate cancer is not medically necessary when the requested course costs more than IMRT or another applicable irradiation approach.

Comparable outcomes alone do not establish medical necessity when the proton course exceeds the comparator cost.

Denial Risk

Regional or Metastatic Prostate Cancer

Proton therapy for regional or metastatic prostate cancer is considered investigational because there is insufficient evidence of improved health outcomes compared with other radiotherapy techniques.

This outcome applies to regional or locally advanced disease and metastatic disease outside the qualifying local or locally advanced pathway.

Denial Risk

Indications Without Qualifying Criteria

When an indication does not meet a qualifying policy pathway, proton therapy is considered investigational because evidence is insufficient to demonstrate improved health outcomes over other radiotherapy techniques.

Apply this outcome to tumor types or indications other than those specifically recognized under the policy criteria.

Denial Risk

Proton SRS or SBRT/SABR

Proton therapy used for stereotactic radiosurgery or stereotactic body or stereotactic ablative radiotherapy is considered investigational.

Applies to proton therapy for SRS.
Applies to proton therapy for SBRT/SABR.

The precise deposition minimizes radiation exposure to surrounding normal tissues

Charged-particle irradiation

Included modalitiesProton beam therapy, carbon ion irradiation, and helium ion irradiation

U.S. availabilityHelium and carbon ion irradiation are not currently available in the United States

Policy focusThe policy primarily focuses on proton beam therapy

Proton beam radiotherapy

Treatment techniqueA radiation treatment technique using proton beams to target tumors

Exit doseProton beam radiotherapy eliminates the exit dose to normal tissues

Potential normal-tissue reductionIt may eliminate approximately 50% of radiation to normal tissue

Intensity-modulated radiation therapy (IMRT)

Radiation typePhoton-based conformal radiation technique

High-dose exposureDecreases high doses to nearby normal tissues

Low- and intermediate-dose exposureDelivers a larger volume of low- and intermediate-dose radiation

Charged-particle radiation therapy coding

Coding structureProton or helium ion radiation therapy typically uses a series of CPT codes for individual steps of care

Care stepsMedical radiation physics, clinical treatment planning, treatment delivery, and clinical treatment management

Treatment-delivery codingTreatment-delivery codes primarily reflect the costs related to the energy source used, not physician work

Unlisted proceduresUnlisted procedure codes may be used for medical radiation physics, clinical treatment planning, and treatment management