CurrentEmblemHealthPolicy MG.MM.PH.334

Medical Policy: Xaracoll (bupivacaine hydrochloride) implant

Defines medical necessity criteria, dosing, limitations, coding, and authorization rules for Xaracoll implants for postsurgical analgesia within EmblemHealth/ConnectiCare programs.

Policy Summary

PayerEmblemHealth

PolicyMedical Policy: Xaracoll (bupivacaine hydrochloride) implant

Policy CodePolicy MG.MM.PH.334

Change TypeAnnual review / operational coding update

Effective DateFeb 2, 2021

Next Review Date

Key ActionTreating physicians must submit clinical evidence that the member meets criteria (age ≥18 and indication of postsurgical analgesia for up to 24 hours following open inguinal hernia repair); approval is granted for 7 days and subsequent approvals require a new authorization.

SourceLink

POLICY UPDATE CHANGES

Annual Review: No criteria changes on 1/2/2025 and prior annual reviews.

1/18/2023 transfer to new template removed code C9399 and added C9089.

1Covered Indications

1Contraindications

3Listed NDCs

2Relevant ICD-10 codes

Coverage Summary

This policy (MG.MM.PH.334) defines medical necessity criteria for Xaracoll (bupivacaine hydrochloride) implants — a bupivacaine collagen-matrix product — for postsurgical analgesia. EmblemHealth developed these criteria based on available clinical information and prescribing information to determine coverage decisions and authorization rules for use within EmblemHealth/ConnectiCare programs.

Scope: Covers use of Xaracoll for postsurgical analgesia after open inguinal hernia repair in adults (18 years and older) when used for up to 24 hours postoperatively; includes dosing limits, coding, documentation and prior authorization requirements under EmblemHealth (policy MG.MM.PH.334).

Policy metadata and thresholds

Policy numberMG.MM.PH.334

Effective date2021-02-02

Last review2025-01-02

StatusCURRENT

SubjectXaracoll (bupivacaine hydrochloride) implant

Scope summaryDefines medical necessity criteria, dosing, limitations, coding, and authorization rules for Xaracoll implants for postsurgical analgesia within EmblemHealth/ConnectiCare programs.

Dose limitSingle administration of 300 mg (3 x 100 mg implants); intended as single-dose administration

Duration of postoperative analgesiaUp to 24 hours following open inguinal hernia repair

Coverage / Medical Necessity Criteria

Medically Necessary / Initial Therapy

Covered when ALL of the following are met:

ALL of the following

Patient is 18 years of age and older
Xaracoll will be used for postsurgical analgesia for up to 24 hours following open inguinal hernia repair

Not Medically Necessary / Investigational

Xaracoll is considered investigational and not medically necessary when used for ANY indications other than the covered indication above.

Any indication other than postsurgical analgesia for up to 24 hours following open inguinal hernia repair

Contraindications

Usage is contraindicated in the following situation:

Obstetrical paracervical block anesthesia

Coding

Applicable HCPCS / Product CodeHCPCSCovered

C9089

Xaracoll 100mg implant bupivacaine, collagen-matrix implant, 1 mg

Applicable CPT / Unclassified Drug Code (billing)HCPCS

J3490

Unclassified drugs (used as product-level unclassified drug code for Xaracoll)

ICD-10 Diagnoses (relevant covered diagnosis)ICD-10Covered

K40.91	Unilateral inguinal hernia, without obstruction, without gangrene, recurrent
K40	Inguinal hernia

NDCsNDCCovered

51715-0100-04	Xaracoll
51715-0100-10	Xaracoll 3x100mg Implant
51715-0100-03	Xaracoll 100mg

Provider Actions / Authorization & Documentation

Prior Authorization

Authorization required

Treating physician or primary care provider must submit clinical evidence that the member meets the criteria for treatment. Approval is granted for 7 days; subsequent approvals require a new authorization.

C9089
J3490

Documentation Required

Clinical documentation required

Submit clinical evidence demonstrating patient age (≥18) and the covered indication: postsurgical analgesia for up to 24 hours following open inguinal hernia repair. Without this documentation EmblemHealth will not be able to properly review the request (preauthorization or post-payment).

Background, Evidence & Definitions

Xaracoll is a bupivacaine collagen-matrix implant designed to block nerve impulse generation and conduction to provide postsurgical analgesia. EmblemHealth's criteria reflect the device's intended single-dose administration (recommended dose 300 mg (3 x 100 mg implants)) and its use for analgesia for up to 24 hours following open inguinal hernia repair.

Definitions:

Bupivacaine: Blocks the generation and the conduction of nerve impulses, presumably by increasing the threshold for electrical excitation in the nerve, by slowing the propagation of the nerve impulse, and by reducing the rate of rise of the action potential.

Evidence
Prescribing information: Xaracoll Prescribing Information: Innocoll Pharmaceuticals Limited; 2020

Revision History

2025-01-02annual_reviewLatest

Annual Review: No criteria changes

2024-01-02annual_review

Annual Review: No criteria changes

2023-03-14annual_review

Annual Review: no revisions

2023-01-18operational_coding_change

Transfer to new template; removed code C9399 and added C9089

2021-02-02policy_origin

Policy originated (Policy New)