Kaiser Permanente SRS/SBRT Coverage Guidance

Coverage Findings and Criteria

CyberKnife — MTAC conclusion (2006)

Evidence-based conclusions from MTAC reviews

CyberKnife general indication: Published literature consists primarily of case reports and small case series without randomized controlled trials or meta-analyses for the CyberKnife radiosurgery system; available evidence is insufficient to determine efficacy for lesions or tumors in any anatomical site per MTAC review.evidence quality

CyberKnife cleared by FDA for lesions in any anatomical site but does not meet Kaiser Permanente MTAC criteria based on available evidence

SRS (Gamma Knife) for ≥5 brain metastases

MTAC evidence conclusion regarding multiple brain metastases

SRS for five or more brain metastases: There is insufficient evidence that stereotactic radiosurgery (SRS), with or without whole brain radiation therapy (WBRT), has non-inferior, equivalent, or superior outcomes compared to WBRT for patients with five or more brain metastases; studies are largely retrospective, observational, or noncomparative.number of lesions >=5

Use does not meet Kaiser Permanente MTAC criteria

SBRT for Prostate Cancer (context and stance)

Context and considerations for SBRT in localized prostate cancer

SBRT for localized prostate cancer: Stereotactic body radiation therapy (SBRT), including delivery by CyberKnife, uses extreme hypofractionation (typically 4–5 fractions totaling approximately 34–39 Gy) as an alternative to conventionally fractionated IMRT; biologic rationale (low alpha/beta) is controversial and current evidence is insufficient to determine comparative effectiveness or long-term durability beyond 3–5 years.fractionation and total dose as described

Consider patient age, comorbidity, tumor risk group, and potential toxicity to bladder/rectum/urethra; larger randomized trials (PACE, HYPO-RT-PC, RTOG 0938) are ongoing.

Gamma Knife — Trigeminal Neuralgia

Gamma Knife for trigeminal neuralgia

Gamma Knife for trigeminal neuralgia: Multiple case series report that a substantial proportion of patients experience pain improvement with low rates of adverse outcomes; however, there are no randomized controlled trials and the evidence is insufficient to meet MTAC criteria for coverage.prior medical therapy attempted

Standard treatment pathway begins with pharmacologic therapy and progresses to surgical options (e.g., percutaneous procedures or microvascular decompression) before considering radiosurgery.

MTAC Evidence Conclusion

Evidence conclusion from MTAC review (10/20/2014):

MTAC Evidence Conclusion: Published small observational phase I/II trials of SBRT report favorable short-term biochemical control and acceptable toxicity, but there is insufficient evidence to determine comparative effectiveness or durability beyond 3–5 years; long-term safety and effects on disease-free, metastasis-free, and overall survival are not established.

Larger randomized trials with longer follow-up are needed (PACE, HYPO-RT-PC, RTOG 0938).

MTAC reviewed the evidence for CyberKnife and determined that the published literature consists primarily of case reports and small case series with no randomized controlled trials or meta-analyses. These uncontrolled series have significant threats to validity and do not provide sufficient evidence to determine efficacy for lesions or tumors in any anatomical site. As a result, MTAC concluded that the use of the CyberKnife Robotic Radiosurgery System for treatment of lesions, tumors, or other conditions in any anatomical site does not meet Kaiser Permanente Medical Technology Assessment Criteria based on available evidence.

MTAC reviewed Stereotactic Body Radiation Therapy (SBRT) specifically for localized prostate cancer and concluded that, based on the available published small observational trials and case series, the evidence is insufficient to meet Kaiser Permanente Medical Technology Assessment Criteria. The policy therefore states that the use of SBRT for prostate cancer does not meet MTAC criteria and is not supported as a covered alternative to established treatments in the absence of stronger comparative evidence.

MTAC identified specific applications where comparative evidence is lacking. For CyberKnife, the literature is limited to case reports and small series without control groups, so efficacy across anatomical sites remains unproven. For Gamma Knife/SRS in patients with ≥5 brain metastases, MTAC found primarily retrospective, observational studies and no randomized trials comparing SRS (with or without WBRT) to WBRT; therefore there is insufficient evidence to conclude non-inferiority or equivalence. These applications were judged to not meet MTAC criteria absent higher-quality comparative data.

At the policy level, MTAC’s determination for prostate SBRT is a non-coverage stance: the use of SBRT for prostate cancer does not meet Kaiser Permanente Medical Technology Assessment Criteria. This policy-level statement reflects the committee’s judgment that current observational data do not establish comparative effectiveness or long-term durability required to support routine coverage.

Procedure and Billing Codes

Referenced external guidance/criteriamixed

No codes listed

Applicable CPT/HCPCS Codes (group 1)mixed

61796	Stereotactic radiosurgery (particle beam, gamma ray, or linear accelerator); 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); 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.
61781	Stereotactic computer-assisted (navigational) procedure; cranial, intradural.
61782	Stereotactic computer-assisted (navigational) procedure; cranial, extradural.
61783	Stereotactic computer-assisted (navigational) procedure; spinal.
63620	Stereotactic radiosurgery (particle beam, gamma ray, or linear accelerator); spinal lesion.
63621	Stereotactic radiosurgery (particle beam, gamma ray, or linear accelerator); each additional spinal lesion.

1–10 of 13

1/2

Applicable CPT/HCPCS Codes (group 2)mixed

77372	Radiation treatment delivery, stereotactic radiosurgery (SRS), complete course of cranial lesion(s) consisting of 1 session; linear accelerator based.
77373	Stereotactic body radiation therapy, treatment delivery, per fraction to one or more lesions, including image guidance, entire course not to exceed 5 fractions.
77432	Stereotactic radiation treatment management of cranial lesion(s) (complete course of treatment consisting of 1 session).
77435	Stereotactic body radiation therapy, treatment management, per treatment course, to one or more lesions, including image guidance, entire course not to exceed 5 fractions.
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.

Number of brain metastases — threshold (≥ 5 lesions)

ThresholdStereotactic radiosurgery (SRS) for patients with five or more brain metastases: insufficient evidence to support equivalence or non‑inferiority to WBRT; identified threshold = ≥ 5 lesions

Evidence basisLiterature is largely retrospective and observational; no randomized controlled trials comparing SRS (with or without WBRT) to WBRT for ≥5 lesions

MTAC conclusionUse of Gamma Knife/SRS for five or more brain metastases does not meet Kaiser Permanente Medical Technology Assessment Criteria

Prostate SBRT fractionation (34–39 Gy in 4–5 fractions)

Recommended regimenTotal dose commonly 34–39 Gy delivered in 4–5 fractions

Authorization, Documentation, and Clinical Workflow

Denial Risk

Denial Triggers — Evidence and MTAC Nonconformance

Evidence-based denial triggers: Services lacking sufficient high-quality evidence or not meeting Kaiser Permanente Medical Technology Assessment Criteria (MTAC) may be considered not medically necessary. Examples include CyberKnife stereotactic radiosurgery where only case series/case reports exist without comparative trials, and Stereotactic Body Radiation Therapy (SBRT) for prostate cancer which does not meet MTAC. Requests for indications with insufficient evidence (e.g., treatment of five or more brain metastases where comparative effectiveness versus WBRT is unproven) may be denied.

CyberKnife: limited evidence (case series, no randomized trials) — denial risk if submitted as routinely indicated for sites without demonstrated benefit
SBRT for prostate cancer: does not meet MTAC — not medically necessary
SRS/SBRT for ≥5 brain metastases: insufficient evidence of non-inferiority to WBRT

Prior Authorization

Coverage Determination

Clinical Background and Scope

Stereotactic radiosurgery (SRS) and stereotactic body radiation therapy (SBRT) are precision radiation techniques that deliver highly focused beams to a defined target with stereotactic localization and image guidance. SRS is typically delivered as a single high-dose session for intracranial targets using framed or frameless systems, while SBRT (including CyberKnife) is a frameless, image-guided approach used for extracranial sites. For prostate SBRT, treatment commonly uses implanted gold fiducial markers and image guidance to deliver hypofractionated high-dose therapy, most often a total of 34–39 Gy delivered in 4–5 fractions. Clinical decision-making should account for tumor size, prior radiation, proximity to critical structures, and available comparative evidence, which for many indications remains limited.

Key Terms and Technology Definitions

SRS definition (stereotactic radiosurgery)

DefinitionStereotactic radiosurgery (SRS): stereotactic delivery of multiple cross‑fired, highly focused radiation beams to a point or volume, often as a single high‑dose session for intracranial targets

Key componentsRequires imaging for localization (CT/MRI/angiography), head position stabilization (frame or frameless), computer‑assisted localization, and precise treatment planning

Typical indicationsOriginally designed for functional brain lesions and small intracranial tumors, including brain metastases, AVMs, pituitary adenomas, and acoustic neuromas

SBRT (prostate) definition

DefinitionStereotactic body radiation therapy (SBRT) for prostate: non‑surgical, highly targeted external beam photon radiotherapy delivering hypofractionated high doses to the prostate over a small number of fractions

OpenPayer

Clinical Review Criteria — CyberKnife, Gamma Knife/SRS, and SBRT (including prostate SBRT and multiple brain metastases)

Coverage Findings and Criteria

Procedure and Billing Codes

Authorization, Documentation, and Clinical Workflow

Clinical Background and Scope

Key Terms and Technology Definitions