CurrentAetnaPolicy 0551

Radiation Treatment for Selected Nononcologic Indications

Defines Aetna's medical necessity, investigational determinations, and related coding for use of radiation therapy for selected non-cancer conditions (e.g., keloids, heterotopic ossification, Ledderhose disease, pterygium) and identifies devices/techniques considered investigational.

Policy Summary

PayerAetna

PolicyRadiation Treatment for Selected Nononcologic Indications

Policy CodePolicy 0551

Change TypeNo material change

Effective DateAug 14, 2001

Next Review DateJun 13, 2024

Key ActionFor keloids, deliver adjunctive radiation within 7 days of excisional surgery when keloid removal meets medical necessity criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

45–100%reported recurrence rate after excision alone

≥30 Gykeloid BED recommended

~90%pterygium control

58%seizure reduction (avg)

83%Ledderhose final local control

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Coverage Criteria and Determinations

Medically Necessary Indications

Covered when ALL of the following are met:

Keloid adjuvant radiation: Low-dose or high-dose radiation (superficial or interstitial) as adjunctive therapy immediately following excisional surgery for keloids when medical necessity criteria for keloid removal are met (see CPB 0031).within 7 days post-excision

See policy statement; timing required for adjuvant RT.

Prevention of heterotopic ossification: Radiation therapy (preoperative or postoperative) for prevention of heterotopic ossification in persons identified as high risk (previous heterotopic ossification, ankylosing spondylitis, diffuse idiopathic skeletal hyperostosis or spinal stenosis, unlimited hip motion preoperatively, and head injury).high-risk features present

Policy identifies specific high-risk features.

Ledderhose disease: Radiation therapy for treatment of Ledderhose disease (plantar fibromatosis) when conventional treatments (e.g., tamoxifen, verapamil, steroid injections) have failed.failure of conservative therapy

Policy specifies conventional therapy failure as prerequisite.

Beta irradiation for pterygium: Use of beta irradiation for prevention of primary or recurrent pterygium when medical management is insufficient or not appropriate.medical management insufficient or not appropriate

Policy states beta irradiation is medically necessary for pterygium not amenable to medical management.

Experimental / Investigational

Considered experimental and investigational:

TRASER device: TRASER (Total Reflection Amplification of Spontaneous Emission Radiation) device is considered experimental and investigational for treatment of nasal telangiectasias because effectiveness has not been established.use of TRASER for nasal telangiectasias

Policy explicitly designates TRASER as experimental/investigational.

Ablative radiotherapy for cardiac arrhythmia: Ablative radiotherapy (noninvasive stereotactic cardiac radio-ablation) for treatment of cardiac arrhythmia is experimental and investigational because effectiveness has not been established.use for cardiac arrhythmia

Policy explicitly designates ablative radiotherapy for arrhythmia as experimental/investigational.

Keloids — evidence-supported contexts

Keloids — clinical settings where radiotherapy (brachytherapy or electron/superficial X-ray) has been used and outcomes reported:

Postoperative adjuvant brachytherapy for keloids: Adjuvant HDR or LDR brachytherapy following surgical excision has been used to reduce recurrence and improve symptoms and cosmesis; reported HDR regimens include 2 × 6 Gy with the first fraction within hours of surgery, and series report low recurrence (e.g., 3.1% in a prospective HDR series) and high patient satisfaction.immediate postoperative irradiation (examples: first fraction within 4 hours; second within 24 hours)

Multiple observational and prospective series summarized in policy.

Factors associated with higher recurrence: Younger age (<44 years), male sex, certain anatomic sites (arms, neck, chest wall), and symptomatic keloids were associated with higher recurrence in some series.clinical risk factors present

Reported by De Cicco et al and others.

Nasal telangiectasias — TRASER

Nasal telangiectasias — TRASER device evaluations:

TRASER therapy evidence: Small prospective studies (e.g., n=13–15) reported high short-term vessel clearance, good tolerance, and no serious adverse events; 1-year follow-up in a subset showed most patients maintained clinically significant improvement but sample sizes and follow-up are limited.device evaluation in small trials

Policy notes preliminary findings and need for larger, well-designed studies.

Cardiac ablation (arrhythmia)

Ablative radiotherapy for cardiac arrhythmia — investigational use:

Stereotactic radio-ablation for refractory VT: Noninvasive electrophysiology-guided radio-ablation (reported single-fraction 25 Gy) has been used in small series for high-risk refractory ventricular tachycardia with marked reductions in VT episodes; safety and durability require validation in larger trials.use in refractory VT in early series

Policy summarizes early case series demonstrating large VT burden reduction but calls for further study.

Focal epilepsy

Radiotherapy for drug-resistant non-neoplastic focal epilepsy:

Seizure reduction reports: A systematic review of heterogeneous studies (16 studies, n≈170) found on average 58% of patients reported no or rare seizures after radiotherapy, but evidence level was low (level 4) and about 20% required subsequent surgery for complications or persistent seizures; prospective randomized trials are needed.drug-resistant non-neoplastic focal epilepsy

Policy cites systematic review and emphasizes limited quality of evidence.

Ledderhose disease

Ledderhose disease (plantar fibromatosis):

Radiotherapy for early-stage Ledderhose disease: En face electron RT or ortho-voltage RT has been used to stabilize or improve symptoms in most patients, with reported symptom improvement (e.g., pain and strain improvement in ~81%), high patient-reported success (≈94%), and acceptable toxicity; common dose schemes reported include 21 Gy (3 Gy ×7) or 30 Gy (3 Gy ×10) with possible breaks and re-irradiation for in-field progression can achieve additional control.early-stage disease or failure of conservative measures

Policy summarizes observational cohort outcomes and typical dosing schemes.

Stereotactic/ablative radiotherapy delivery codes are not covered for the nononcologic indications addressed in this policy. Specifically, CPT codes 77373 (stereotactic body radiation therapy, treatment delivery, per fraction) and 77435 (stereotactic body radiation therapy, treatment management, per treatment course) are listed as not covered for the indications in this Clinical Policy Bulletin. Covered radiation delivery and brachytherapy codes (e.g., CPT 77401‑77417, 77767‑77772, 77778) remain available when the policy’s medically necessary selection criteria are met.

Evidence for radiotherapy in drug‑resistant, non‑neoplastic focal epilepsy is limited and heterogeneous. A systematic review identified small, low‑level studies (total n≈170) with an average of 58% of patients reporting no or rare seizures after radiotherapy, but the review rated the evidence as level 4 and noted that 20% of patients ultimately required subsequent surgery for complications or persistent seizures. Authors conclude that prospective randomized trials are needed before routine adoption.

This Clinical Policy Bulletin provides a partial, general description of plan or program benefits and is intended to assist with administration of benefits. It does not constitute a contract, guarantee coverage, or replace plan‑specific provisions. Coverage determinations remain subject to the terms of the member’s plan, applicable administrative rules, and any applicable prior authorization requirements.

The TRASER device (Total Reflection Amplification of Spontaneous Emission Radiation) and ablative radiotherapy for cardiac arrhythmia are considered experimental and investigational because effectiveness has not been established; use of these approaches for nasal telangiectasias or cardiac arrhythmia is therefore not supported as medically necessary by this policy.

Several preliminary reports and small series have described early outcomes for novel indications such as noninvasive cardiac radio‑ablation (single‑fraction SBRT ~25 Gy) and radiotherapy for focal epilepsy. These publications show promising reductions in arrhythmia burden and seizure frequency in selected patients, but sample sizes are small, follow‑up limited, and authors emphasize the need for larger, controlled studies before these approaches can be considered established therapies.

Coding and Dose Examples

Covered CPT Codes (when selection criteria met)CPTCovered

77401-77417	Radiation treatment delivery [includes beta irradiation]
77767-77772	Remote afterloading high dose rate radionuclide skin surface brachytherapy, includes basic dosimetry, when performed
77778	Interstitial radiation source application, complex, includes supervision, handling, loading of radiation source, when performed

CPT Codes Not Covered for Listed Indications (ablative radiotherapy)CPTNot Covered

77373	Stereotactic body radiation therapy, treatment delivery, per fraction to 1 or more lesions, including image guidance, entire course not to exceed 5 fractions [ablative radiotherapy]
77435	Stereotactic body radiation therapy, treatment management, per treatment course, to 1 or more lesions, including image guidance, entire course not to exceed 5 fractions [ablative radiotherapy]

Codes Related to TRASER (no specific CPT code)neutralNot Covered

TRASER

No specific code

ICD-10 Codes Covered (when selection criteria met)ICD-10Covered

L91.0	Hypertrophic scar [keloid]
M08.1
M45.0-M45.9	Ankylosing spondylitis
M48.00-M48.08	Spinal stenosis
M72.2	Plantar fascial fibromatosis
S06.0x0+-S06.9x9+	Intracranial injury

ICD-10 Codes Not Covered for Listed Indications / ExperimentalICD-10Not Covered

I78.1	Nevus, non-neoplastic [nasal telangiectasias]
I49.01-I49.9	Other cardiac arrhythmias

Codes not specified in this sectionmixed

No codes listed

Keloid BED — BED ≥ 30 Gy

Biologically effective dose (BED) thresholdBED ≥ 30 Gy for prevention of keloid recurrence after surgical excision

Example dose equivalents (from source)1 single acute dose of 13 Gy; 2 fractions of 8 Gy; 3 fractions of 6 Gy; or 1 single 27 Gy at low-dose rate yield BED ≈30 Gy

Timing recommendationRadiation should be administered within 2 days following surgery (policy notes suggest within 7 days for coverage criteria)

Pterygium dose examples — 30 Gy total (3 fractions) or 10 Gy single β-RT; various schedules

Standard multi-fraction example30 Gy total delivered as 3 fractions (10 Gy per fraction delivered weekly) — used as a postoperative strontium-90 schedule

Provider Actions, Prior Authorization & Billing

Billing Rule

Coding and Billing Guidance

Prior authorization and coding implications: Radiation delivery CPT codes (77401-77417, 77767-77772, 77778) are covered when the policy's selection/medical necessity criteria are met (e.g., keloid excision with RT within 7 days, heterotopic ossification prevention in high-risk persons, Ledderhose disease after failure of conservative therapy). When billing, include applicable CPT/HCPCS and ICD-10 codes and document the treatment intent (adjunctive post-op for keloid, prophylaxis for heterotopic ossification, or treatment for Ledderhose disease).

Covered CPT ranges (when criteria met): 77401-77417, 77767-77772, 77778
ICD-10 examples supporting coverage when criteria met: L91.0 (keloid), M72.2 (plantar fascial fibromatosis), M45.x (ankylosing spondylitis), S06.x (intracranial injury) for HO risk factors
Keloid: radiation as adjunctive therapy within 7 days post-excision when keloid removal is medically necessary per CPB 0031

Background and Context

Keloids are benign dermal proliferations arising after skin injury and are notable for high recurrence after excision alone (reported recurrence rates of 45–100%). Adjuvant post‑operative radiation administered promptly after excision reduces recurrence; studies and consensus reporting suggest a biologically effective dose of at least BED ≥ 30 Gy is associated with improved prevention of keloid recurrence when delivered as adjunctive therapy within the early postoperative window.

Definitions and Key Terms

Heterotopic ossification (HO) — definition and role of RT in prevention

DefinitionHeterotopic ossification (HO) is an overgrowth of bone that frequently occurs after a bone fracture, commonly affecting spine, hip, or elbow and causing pain and disability

Role of radiationPreoperative or postoperative radiation therapy is effective in preventing HO in patients identified as high risk (e.g., prior HO, ankylosing spondylitis, diffuse idiopathic skeletal hyperostosis, spinal stenosis, unlimited hip motion preoperatively, head injury)

Treatment mechanismRadiation works locally by damaging cellular DNA to prevent bone overgrowth

Biologically effective dose (BED) for keloid prevention — BED of at least 30 Gy suggested

Recommended BED for preventionA biologically effective dose (BED) of at least 30 Gy is suggested for successful prevention of keloid recurrence after surgical excision

Policy Dates and Revision History

2001-08-14effective_date

Policy became effective.

2023-07-27last_reviewLatest

Policy was last reviewed.

2024-06-13next_review

Next scheduled policy review date.

Policy Summary

PayerAetna

PolicyRadiation Treatment for Selected Nononcologic Indications

Policy CodePolicy 0551

Change TypeNo material change

Effective DateAug 14, 2001

Next Review DateJun 13, 2024

Key ActionFor keloids, deliver adjunctive radiation within 7 days of excisional surgery when keloid removal meets medical necessity criteria.

SourceLink

On This Page

Single low-dose beta-RT example10 Gy single β-RT after conjunctival autograft (CAG) — shown to improve control and cosmetics

Range of BEDs reportedVarious low-fractionation schedules reported with BED (10) in the range of ~24–52.5 Gy(10)

HDR keloid regimen example — 2 × 6 Gy fractions (timing post-op specified)

HDR brachytherapy example regimen2 × 6 Gy fractions (first fraction within 4 hours after surgery; second fraction within 24 hours)

Reported outcomes with this schedule3.1% recurrence at mean follow-up of 33.6 months; high patient satisfaction and symptom improvement reported

RationaleImmediate postoperative irradiation and short overall treatment time associated with effectiveness in reported prospective series

Cardiac SBRT example dose — Single fraction of 25 Gy

Example cardiac SBRT doseSingle fraction of 25 Gy delivered to arrhythmogenic myocardial substrate (as used in case series)

Clinical contextNoninvasive electrocardiographic imaging–guided stereotactic radio-ablation for refractory ventricular tachycardia

Reported efficacy signalIn a 5-patient series, VT episodes reduced by 99.9% after a 6-week blanking period

Ledderhose dose schemes (examples) — 21 Gy (3 Gy ×7) or 30 Gy (3 Gy ×10) with possible break

Common Ledderhose dose scheme A21 Gy delivered as 3 Gy × 7 fractions

Common Ledderhose dose scheme B30 Gy delivered as 3 Gy × 10 fractions (with 6–8 week break after 15 Gy in some protocols)

Clinical noteEn face electron RT or ortho-voltage RT used to stabilize/improve symptoms; re-irradiation can be effective for in-field progression

Prior Authorization — Case-by-Case Review

Prior authorization: case-by-case review is likely for novel or nonstandard indications (for example, radiotherapy for drug-resistant epilepsy or SBRT for cardiac arrhythmia); consult Aetna Clinical Policy Bulletin and plan provisions for any required prior authorization processes.

Novel/nonstandard indications (e.g., cardiac arrhythmia ablation with radiotherapy, TRASER device use) will generally require individual review
Consult applicable plan prior authorization requirements and the Aetna Clinical Policy Bulletin notes linked in the policy

Prior Authorization

Prior Authorization Requirements

Prior authorization requirements: Providers must follow the member's plan benefits and any Clinical Policy Bulletin instructions. Prior authorization may be required per plan; when in doubt, obtain pre-service review documentation to substantiate medical necessity.

Refer to Aetna Clinical Policy Bulletin and the member's plan provisions for specific prior authorization processes
Obtain pre-service review when required by the plan to avoid claim denials

Denial Risk

Experimental / Not Covered Techniques

Experimental/investigational exclusions: Use of the TRASER device and ablative radiotherapy for cardiac arrhythmia are considered experimental/investigational and are not covered because effectiveness has not been established.

TRASER (Total Reflection Amplification of Spontaneous Emission Radiation) — experimental/investigational for nasal telangiectasias
Ablative radiotherapy for cardiac arrhythmia (e.g., SBRT for VT) — experimental/investigational; associated CPT codes for SBRT (77373, 77435) are not covered for this indication

Documentation Required

Clinical Documentation Requirements

Documentation expectations: Clinical documentation must support the diagnosis, prior conservative treatments tried, and treatment intent. For Ledderhose disease and other benign indications, document failure of conventional therapies and rationale for radiotherapy (including prior injections, medications, or conservative measures).

Document diagnosis with appropriate ICD-10 code and clinical findings
Document conservative therapies attempted (e.g., tamoxifen, verapamil, steroid injections, shoe inserts, shockwave therapy) and their failure or intolerance
For keloid RT, document timing of excision and that RT is delivered within 7 days post-excision as adjunctive therapy

Documentation Required

Ledderhose (Plantar Fibromatosis) — Provider Actions

Ledderhose-specific provider actions: Radiation therapy may be medically necessary for plantar fibromatosis when conventional treatments have failed. Expect documentation of prior conservative measures and clear treatment intent; RT dosing/fields should be consistent with published practices (e.g., en face electrons, typical dose schemes noted in literature).

Indication: Plantar fascial fibromatosis (Ledderhose disease) — consider RT after failure of conservative measures
Document prior conservative and operative treatments and rationale for RT; record dose/fractionation and treatment field details in chart

Denial Risk

Conservative Measures, Documentation & Denial Risk

Conservative measures and denial risk: Conservative treatments should be attempted for Ledderhose and other benign conditions prior to radiotherapy. There are no explicit denial triggers listed in this portion of the document beyond the listed experimental/investigational exclusions; however, failure to document prior conservative care or to meet the policy's selection criteria may increase risk of denial.

Conservative measures examples: steroid injections, tamoxifen, verapamil, shoe inserts, extracorporeal shockwave therapy
No explicit insurer-specific prior-authorization triggers are described in this document segment; follow plan rules and bulletin guidance
Lack of adequate documentation of prior therapies and medical necessity is a common reason for claim denial

Note

Administrative Notes

Administrative/provider notes: Preserve policy history and follow plan benefits and Clinical Policy Bulletin guidance for any operational questions. This section does not list additional explicit denial triggers beyond those noted above.

Policy effective date: 2001-08-14; last review 07/27/2023; next review 06/13/2024
Refer to Clinical Policy Bulletin Notes and plan-specific administrative procedures for submission and appeals

Example fractionation equivalents to reach BED ≥30 Gy

Single 13 Gy, 2 × 8 Gy, 3 × 6 Gy, or single 27 Gy at low-dose rate are cited as achieving BED ≈30 Gy

Timing importanceShort overall treatment time and immediate postoperative delivery (within 2 days recommended in background; policy notes also reference within 7 days for coverage) increase effectiveness

Cardiac radio-ablation / stereotactic arrhythmia radio-ablation — definition and typical single-fraction example

DefinitionCardiac radio-ablation (stereotactic arrhythmia radio-ablation) is noninvasive delivery of ablative radiation to arrhythmogenic myocardial substrates guided by noninvasive electrocardiographic imaging and anatomical imaging

Typical ablative dose exampleSingle-fraction stereotactic treatment of 25 Gy delivered to the target (used in reported case series)

Evidence statusReported efficacy in small case series with marked reductions in VT episodes; considered investigational pending larger trials

TRASER — definition and context for nasal telangiectasias evaluation

DefinitionTRASER (Total Reflection Amplification of Spontaneous Emission Radiation) is a configurable narrow-spectral light device evaluated for treatment of nasal telangiectasias

Clinical findingsSmall prospective studies report high short-term vessel clearance and good tolerance; majority demonstrate clinically significant improvement at 1 year in limited follow-up cohorts

Evidence limitationStudies are small with short follow-up; authors recommend validation in larger well-designed trials

Ledderhose disease / plantar fibromatosis — definition and note that it's a benign indication referenced in policy

DefinitionLedderhose disease (plantar fibromatosis) is a benign hyperproliferative disorder of the deep fascia of the sole leading to nodules/cords and symptoms such as pain and functional limitation

Role in policyReferenced as a benign indication for radiotherapy; RT is considered medically necessary when conservative treatments have failed

Reported dose examples and outcomesCommon dose schemes include 21 Gy (3 Gy ×7) and 30 Gy (3 Gy ×10 with 6–8 week break after 15 Gy); RT stabilized or improved symptoms in majority with high patient satisfaction