CurrentUnitedHealthcarePolicy 2025R5019C

Device, Implant, and Skin Substitutes with Associated Procedures

Defines UnitedHealthcare reimbursement and coding requirements for reporting devices, implants, and skin substitutes on outpatient and inpatient hospital claims, including device-dependent procedures, device credits, FDA implant classification, and skin substitute product/procedure pairings. Applies to UnitedHealthcare Commercial and Individual Exchange benefit plans.

Policy Summary

PayerUnitedHealthcare

PolicyDevice, Implant, and Skin Substitutes with Associated Procedures

Policy CodePolicy 2025R5019C

Change TypePolicy list updates (no material clinical changes)

Effective Date

Next Review Date

Key ActionSubmit the device or implant code on the same claim and same date of service as the related device-dependent procedure; procedures reported without an applicable device/implant will be denied unless appropriately modified for a discontinued procedure.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2025R5019Cdocument identifier

outpatient & inpatientsetting

HCPCS with rev code 0278 (outpatient)billing requirement

low & high skin substitute listsexplicit code lists included

Device, Implant and Skin Substitute Reporting Rules

Device or implant dependent procedure reporting

Conditions under which device/implant and procedure must be reported together for reimbursement.

ALL of the following

When use of a device or implant is necessary for performance of a procedure, the device/implant must be submitted on the same claim and same date of service as the procedure.
A device/implant-dependent procedure will be denied if reported without an applicable device or implant on the same claim and date of service.
Procedure code without device may be considered only if service discontinued prior to placement and appropriate modifier for discontinued procedure is appended.
Devices/implants or brachytherapy sources with OCE Status Indicator H or U will be denied if reported without a procedure with OCE Status J1, S, or T on same date and claim.

FDA implant revenue code submission rules

Requirements for implant revenue code reporting and FDA product classification application.

ANY of the following

For outpatient services: when a revenue code representing implants is submitted, a HCPCS code that meets the FDA definition of an implant must be reported; otherwise the claim line will not be reimbursed.
For inpatient services: when a revenue code representing implants is submitted, medical records may be requested to verify the device meets the FDA implant definition; if not, the implant revenue code line will not be reimbursed.
FDA defines an implant as a device placed into a surgically or naturally formed cavity intended to remain implanted continuously for 30 days or more (unless Commissioner determines otherwise).

Skin substitute reporting constraints

Rules pairing low-cost/high-cost skin substitute products with corresponding procedures.

ALL of the following

Low cost skin substitute products may only be reported with low cost skin substitute procedures.
High cost skin substitute products may only be reported with high cost skin substitute procedures.

Code Lists and Status

Skin substitute low proceduresmixedCovered

C5271	Skin substitute low product (listed in policy as low-cost product code)
C5272	Skin substitute low product
C5273	Skin substitute low product
C5274	Skin substitute low product
C5275	Skin substitute low product
C5276	Skin substitute low product
C5277	Skin substitute low product
C5278	Skin substitute low product

Skin substitute high proceduresmixedCovered

15271	Skin substitute high procedure
15272	Skin substitute high procedure
15273	Skin substitute high procedure
15274	Skin substitute high procedure
15275	Skin substitute high procedure
15276	Skin substitute high procedure
15277	Skin substitute high procedure
15278	Skin substitute high procedure
15777	Skin substitute high procedure

Examples of HCPCS that do not meet FDA implant definition (partial list)HCPCSNot Covered

C1753	Listed in policy as not meeting FDA implant definition in combinations
C1725	Listed in policy as not meeting FDA implant definition in combinations
C1754	Resultant code in example list
C1755	Resultant code in example list
C1756	Resultant code in example list
C1757	Resultant code in example list
C1758	Resultant code in example list
C1759	Resultant code in example list

Billing Rules, Documentation and Device Credit Reporting

Billing Rule

Submit device/implant with procedure on same claim/date

Submit the device or implant code on the same claim and same date of service as the related device-dependent procedure. Procedures reported without applicable device/implant will be denied unless discontinued and an appropriate discontinued-procedure modifier is used.

Billing Rule

OCE status indicator restrictions

Do not report devices/implants or brachytherapy sources with OCE Status H or U without a procedure having OCE Status J1, S, or T on the same claim and date; such device lines will be denied otherwise.

Billing Rule

HCPCS required with implant revenue code 0278 (outpatient)

For outpatient claims billed under implant revenue code 0278, a HCPCS code meeting the FDA definition of an implant must be submitted; otherwise the implant revenue line will not be reimbursed. This HCPCS requirement does not apply to inpatient claims.

Revenue code 0278 (implant revenue code)

Billing Rule

Device credit reporting

When a device/implant was obtained at no cost or reduced cost, submit the appropriate condition code, value code FD, and modifier FB (no cost/full credit) or FC (partial credit) as applicable.

Condition codes: 49, 50, 53
Value code: FD
Modifiers: FB, FC

Documentation Required

Medical records may be requested for inpatient implants

For inpatient services billed with implant revenue codes, UnitedHealthcare may request medical records to verify the device meets the FDA implant definition; if verification fails, the implant revenue line will not be reimbursed.

Key Terms and Codes

Definitions

Implant (FDA definition)A device placed into a surgically or naturally formed cavity intended to remain implanted continuously for 30 days or more, unless the Commissioner determines otherwise.

Device-dependent procedureA procedure for which use of a device or implant is necessary and reimbursement requires reporting the device/implant on the same claim and same date of service; a procedure reported without an applicable device will be denied unless the service was discontinued prior to placement and an appropriate discontinued-procedure modifier is appended.

OCE Status IndicatorsIntegrated Outpatient Code Editor status indicators used to determine claim pairing requirements (examples: H = pass-through device, U = brachytherapy source; procedures with J1, S, or T status are required on same date/claim when these device statuses are reported).

Condition code 49Product Replacement within Product Lifecycle — replacement of a product earlier than the anticipated lifecycle.

Condition code 50Product Replacement for Known Recall — replacement due to a manufacturer or FDA identified recall.

Condition code 53Initial placement of a medical device provided as part of a clinical trial or free sample (used for outpatient claims receiving device credit upon initial placement in a clinical trial or free sample).

Value code FDCredit received from the manufacturer for a medical device.

Modifier FBItems without cost to the provider, supplier, or practitioner, or full credit received for replaced device (e.g., covered under warranty, replaced due to defect, free sample).

Modifier FCPartial credit for a replaced device.

Policy Background and Scope

This policy defines UnitedHealthcare reimbursement and coding requirements for reporting devices, implants, and skin substitutes on outpatient and inpatient hospital claims. It applies to UnitedHealthcare Commercial and Individual Exchange benefit plans and describes when device or implant codes must be reported with associated procedure codes, how device credit (no cost or reduced cost) should be reported, and the application of FDA product classification to implant revenue coding for both outpatient and inpatient settings. (See policy overview and application of CMS OCE/OPPS guidance.)

For outpatient hospital services, the policy applies CMS Integrated Outpatient Code Editor (OCE) criteria to determine device/implant and skin substitute reporting requirements and pairs those criteria with UnitedHealthcare claim-edit rules. It requires that when the use of a device or implant is necessary to perform a procedure, the device/implant must be submitted on the same claim and same date of service as the procedure, and device-dependent procedures reported without an applicable device will be denied unless the procedure was discontinued and an appropriate discontinued-procedure modifier is appended.

UnitedHealthcare applies the FDA product classification definition of an implant for revenue coding: an implant is a device placed into a surgically or naturally formed cavity and intended to remain implanted continuously for 30 days or more unless the FDA Commissioner determines otherwise. For outpatient claims submitted under an implant revenue code, a HCPCS code that meets the FDA implant definition must be reported or the implant revenue line will not be reimbursed. For inpatient claims, UnitedHealthcare may request medical records to verify the device meets the FDA implant definition; if it does not, the implant revenue line will not be reimbursed.

The policy also specifies skin substitute pairing rules: low-cost skin substitute products may only be reported with low-cost skin substitute procedures, and high-cost skin substitute products may only be reported with high-cost skin substitute procedures. The policy references specific product and procedure lists (see attached Device Dependent Devices List, Device Dependent Procedure List, Skin Substitute Low Product List, and Skin Substitute High Product List) and applies CMS OPPS/OCE guidance in its coding rules.

This document includes a history of list updates and archive entries with multiple update dates; the history contains entries through 7/13/2025 documenting policy list updates (Device Dependent Procedure List, Skin Substitute Low Product List, Skin Substitute High Product List, and related device lists) and archival of earlier entries as noted in the policy history.

Policy Summary

PayerUnitedHealthcare

PolicyDevice, Implant, and Skin Substitutes with Associated Procedures

Policy CodePolicy 2025R5019C

Change TypePolicy list updates (no material clinical changes)

Effective Date

Next Review Date

SourceLink

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