CurrentIndependent HealthPolicy M20240924031

Transperineal Placement of Biodegradable Material for Prostate Cancer (Barrigel)

Defines Independent Health's medical necessity criteria and coverage stance for transperineal placement of the biodegradable rectal spacer Barrigel in members undergoing external radiotherapy for localized prostate cancer; applies to commercial, Medicare Advantage, and specified state plans.

Policy Summary

PayerIndependent Health

PolicyTransperineal Placement of Biodegradable Material for Prostate Cancer (Barrigel)

Policy CodePolicy M20240924031

Change TypeMinor — no material changes

Effective DateNov 1, 2024

Next Review Date

Key ActionObtain preauthorization and document imaging confirming organ-confined prostate cancer without rectal invasion or posterior extension.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

FDA-clearedRegulatory

Covered w/ criteriaCoverage

PreauthAuthorization

Rectal invasion/T3Exclusion

MediSource, MAPD, Commercial

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Coverage Criteria

Medical necessity criteria

Covered when ALL of the following are met

ALL of the following

Anatomic placement: The Barrigel will be implanted between the prostate and rectum
Treatment intent: The member is undergoing external radiotherapy with organ-confined prostate cancer in order to displace the rectum from high radiation dose regions
Imaging criteria: Imaging indicates the cancer has not invaded into the rectum or extended beyond the posterior region of the prostate
Patients with obvious rectal invasion or visible T3 and posterior extension should not undergo perirectal spacer implantation (not covered).

Patients who have obvious rectal invasion by prostate cancer or a visible T3 posterior extension should not undergo perirectal spacer (Barrigel) implantation. This anatomic finding indicates tumor extension into or through the posterior prostate margin and/or rectal wall, and perirectal spacer placement is contraindicated because it would not achieve the intended separation and may interfere with appropriate oncologic management.

Perirectal spacer implantation in the presence of rectal invasion or posterior extension (visible T3) is considered not covered / not medically necessary under this policy.

Coding

Covered CPT Codes (per document references)CPTCovered

CPT 55874

Transperineal placement of biodegradable material (e.g., perirectal spacer) for prostate radiation therapy

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Preauthorization is required for transperineal placement of biodegradable material (Barrigel). Providers must obtain prior authorization before scheduling or performing this service. Lack of required preauthorization may result in denial of payment.

CPT 55874

Note

LOB-specific Requirement

For MediSource, MediSource Connect, Child Health Plus and Essential Plan members, coverage follows the Commercial criteria when using CPT 55874. For these lines of business, transperineal placement of biodegradable material is not covered unless the Commercial criteria are met.

Applies to: MediSource, MediSource Connect, Child Health Plus, Essential Plan
Affected code: CPT 55874

Background

Rectal toxicity from prostate radiotherapy results from the close proximity of the prostate and rectum and may present as diarrhea, fecal incontinence, proctitis, or ulceration. Biodegradable perirectal spacers such as Barrigel are injected between the prostate and rectum to temporarily increase separation, reduce rectal dose during external radiotherapy, and thereby decrease the risk of radiation-induced rectal toxicity. Barrigel is a biodegradable rectal spacer intended to position the anterior rectal wall away from the prostate for the duration of radiotherapy.

Definitions

Barrigel — definition and composition

Product nameBarrigel injectable gel

CompositionNonanimal stabilized hyaluronic acid (NASHA) at 20 mg/mL in phosphate buffered saline; described elsewhere in the policy as biodegradable hyaluronic acid and polyethylene glycol formulations

Formulation / deliveryInjectable gel delivered via syringe under ultrasound guidance (transrectal ultrasound) for transperineal placement between the prostate and rectum

Intended useTemporarily position the anterior rectal wall away from the prostate during radiotherapy for localized prostate cancer to reduce rectal radiation dose

Duration / biodegradationMaintains space for the radiotherapy course (~3 months) and subsequently degrades by hydrolysis with renal excretion by about 6 months

Documentation Required

Required Clinical Documentation

Documentation must demonstrate that the member has organ-confined prostate cancer without rectal invasion or posterior extension, and that imaging confirms placement between the prostate and rectum. Clinical records should include imaging reports (e.g., MRI or transrectal ultrasound), indication for external beam radiotherapy, and operative or procedure notes documenting Barrigel insertion and anatomic placement.

Imaging confirming no rectal invasion and no posterior extension
Evidence the Barrigel will be implanted between prostate and rectum
Plan for external radiotherapy for localized, organ-confined prostate cancer
Procedure note documenting Barrigel insertion and technique