CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Medical Coverage Policy Intraocular Radiotherapy for Age-Related Macular Degeneration

Defines coverage position for intraocular radiotherapy modalities (brachytherapy, proton beam therapy, stereotactic radiotherapy) to treat choroidal neovascularization due to age-related macular degeneration for commercial products and Medicare Advantage; notes benefits may vary by contract.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyMedical Coverage Policy Intraocular Radiotherapy for Age-Related Macular Degeneration

Policy CodePolicy N/A

Change TypeClarified - not covered

Effective DateDec 1, 2022

Next Review Date

Key ActionRefer to the member's certificate/subscriber agreement for benefits and confirm member-specific benefits with the provider call center; this policy is informational and not a guarantee of payment.

SourceLink

POLICY UPDATE CHANGES

Policy states intraocular radiotherapy (brachytherapy, proton beam, stereotactic) is not covered / not medically necessary due to insufficient evidence.

3Modalities considered not covered

67299Unlisted CPT code provided

Coverage Summary

Scope: This policy addresses intraocular radiotherapy modalities (brachytherapy, proton beam therapy, and stereotactic radiotherapy) to treat choroidal neovascularization associated with age-related macular degeneration for commercial products and Medicare Advantage. Coverage stance: Not covered / not medically necessary because evidence is insufficient to determine effects on health outcomes. Subject: Intraocular radiotherapy for age-related macular degeneration. Effective date: 2022-12-01; Last review: 2022-08-03.

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Policy Statement and Medical Necessity

Policy Statement - Coverage Determination

Intraocular radiotherapy for choroidal neovascularization associated with age-related macular degeneration is considered:

Brachytherapy: Intraocular placement of a radiation source (brachytherapy) for treatment of choroidal neovascularization is not covered / not medically necessary because the evidence is insufficient to determine the effects of the technology on health outcomes
Proton beam therapy for treatment of choroidal neovascularization is not covered / not medically necessary because the evidence is insufficient to determine the effects of the technology on health outcomes
Stereotactic radiotherapy for treatment of choroidal neovascularization is not covered / not medically necessary because the evidence is insufficient to determine the effects of the technology on health outcomes

Not Medically Necessary / Not Covered Details

RCT evidence for epimacular brachytherapy showed that trials did not attain noninferiority for visual outcomes and were associated with a higher proportion of adverse events, indicating no improvement in net health outcomes.

Proton beam randomized trials had recruitment halted for ethical concerns and available results did not show statistically significant stabilization of visual acuity, and stereotactic radiotherapy trials reduced the number of anti-VEGF injections but showed no significant differences in visual acuity versus controls. Overall, the evidence across modalities is insufficient to demonstrate clinical benefit and raises concerns about harms and lack of meaningful visual acuity improvement.

Study / Source	Key Finding
Randomized controlled trials	RCTs of brachytherapy did not attain noninferiority for visual outcomes and were associated with a higher proportion of adverse events
Proton beam RCT	Recruitment halted; available results did not show statistically significant stabilization of visual acuity
Stereotactic radiotherapy RCT	RCT showed reduced number of VEGF treatments but no significant differences versus controls for changes in visual acuity

Provider Actions & Billing Guidance

Documentation Required

Benefits may vary by contract

Refer to the member's certificate/subscriber agreement for applicable benefits and eligibility; confirm member-specific benefits with the provider call center as this policy is informational and not a guarantee of payment

Billing Rule

Use of unlisted CPT

Report CPT 67299 (Unlisted procedure, posterior segment) for services/therapies addressed by this policy when no specific CPT code exists

67299

Background, Evidence Summary, and Definitions

Intraocular radiotherapy (epimacular brachytherapy, proton beam, stereotactic) has been investigated as an alternative to repeated intravitreal anti-VEGF injections for neovascular AMD. Evidence includes RCTs, phase 1/2 trials, and case series; RCTs did not demonstrate noninferiority for visual outcomes and reported higher adverse events or no significant visual acuity benefit.

Evidence Source	Summary
Randomized controlled trials	Evidence (Cochrane review and 2 RCTs) for brachytherapy shows failure to attain noninferiority for visual outcomes and higher adverse events; overall evidence insufficient to demonstrate net health benefit
Proton beam RCT	Randomized, prospective, sham-controlled trial halted for ethical concerns; available results did not show statistically significant stabilization of visual acuity; evidence insufficient
Stereotactic radiotherapy RCT	INTREPID RCT showed reduced number of anti-VEGF treatments at 12 and 24 months but no significant visual acuity benefit versus controls; evidence insufficient to show net health benefit

Choroidal neovascularization (CNV): Abnormal blood vessel growth in the choroid associated with wet age-related macular degeneration leading to vision loss.

Epimacular brachytherapy (EPI-RAD/EMBT): Brachytherapy delivering a single focal beta radiation dose via an intraocular device (eg, strontium-90) to a choroidal neovascular lesion, typically a one-time peak dose (reported example: 24 Gray) delivered to a targeted depth and diameter.