CurrentUnitedHealthcarePolicy 2026R5019C

Reporting and reimbursement of devices, implants, and skin substitutes for outpatient and inpatient hospital services

Defines UnitedHealthcare coding and billing requirements for devices, implants, and skin substitutes for outpatient (UB04) and inpatient hospital services and applies to all UnitedHealthcare Commercial and Individual Exchange benefit plans and facility types described.

Policy Summary

PayerUnitedHealthcare

PolicyReporting and reimbursement of devices, implants, and skin substitutes for outpatient and inpatient hospital services

Policy CodePolicy 2026R5019C

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit device or implant codes on the same claim and date of service as device-dependent procedures or the procedure will be denied.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

UB04/outpatientForms and claim types governed

Commercial & ExchangeBenefit plans covered

FDA 30-dayImplant classification rule

Same claim/dateReporting requirement

49,50,53; FD; FB/FC

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Device credit elements

Device, Implant and Skin Substitute Reporting & Reimbursement Criteria

Device/implant/skin substitute reporting and reimbursement criteria

Required claim elements and denial conditions for devices, implants, and skin substitutes.

All of the following criteria must be met for device-, implant-, and skin substitute–related claim lines to be reimbursed:

ALL of the following

Device or implant–dependent procedure codes must be submitted on the same claim and the same date of service as the associated device or implant; otherwise the procedure will be denied.
Applies to procedures identified in OCE HCPCS data file; denial applies when device/implant is missing on same claim/date.
Exception
- If the procedure was discontinued prior to placement of the device or implant, the procedure code may be submitted without the device if an appropriate modifier indicating discontinuation is appended.

ALL of the following

When a skin substitute application or replacement procedure is reported, the associated skin substitute product HCPCS must be submitted on the same claim and same date of service; otherwise the procedure will be denied.
Applicable skin substitute product and procedure codes are defined in the OCE HCPCS data file.

ALL of the following

When an outpatient implant revenue code is submitted, a HCPCS code that meets the FDA implant definition (intended to remain implanted continuously for 30 days or more) must be reported on the claim; if not submitted or not meeting the FDA definition, the implant revenue-line will not be reimbursed.
When an inpatient implant revenue code is submitted, medical records may be requested to verify the FDA implant definition; if verification fails, the implant revenue-line will not be reimbursed.

ALL of the following

Absorbable materials, liquids, supplies, or instruments that are absorbed by surrounding tissue or are intended to be removed/discarded during the same procedure or episode of care are considered integral to the procedure and are not reimbursed as implants.

ALL of the following

When a device or implant was obtained at no cost or at a reduced cost, providers must report device credit using the appropriate condition codes (49, 50, 53), value code FD, and modifiers FB or FC.
Use condition codes and modifiers as specified to report replacement/credit circumstances.

ALL of the following

Devices, implants, or brachytherapy sources with OCE status indicator H (pass-through device) or U (brachytherapy sources) will be denied if reported without a procedure having OCE status J1, S, or T on the same date of service and same claim.

Procedure and Code Guidance

Skin substitute procedure mappingsCPT

15271-15278,15777

Skin substitute procedure crosswalks listed in policy

HCPCS examples not meeting implant definitionHCPCSNot Covered

C1724-C1733, C1753-C1766, C1773-C1894, C2614-C2630, C2615 series

Examples of HCPCS that do not meet FDA implant definition (partial list as shown)

Device credit reporting codesmixed

Condition code 49,50,53; Value code FD; Modifiers FB,FC

Codes/values/modifiers to report device or implant credit when device obtained at no or reduced cost

Implant duration threshold — inv-05: 30-day rule

ThresholdIntended to remain implanted continuously for 30 days or more

ApplicabilityApplies to devices classified as implants under the FDA product classification guidelines used by this policy

Outpatient billing consequenceIf a HCPCS code meeting the FDA implant definition is not submitted with an implant revenue code, the implant revenue-line will not be reimbursed

Inpatient verificationMedical records may be requested to verify that the device meets the FDA implant definition for inpatient services

Billing, Submission and Documentation Requirements for Providers

Billing Rule

Device-dependent procedure submission requirement

When the use of a device or implant is necessary for a procedure, the device or implant must be submitted on the same claim and with the same date of service as the procedure. A device- or implant-dependent procedure will be denied if reported without an applicable device or implant on the same claim and date of service. A procedure submitted without a device or implant may only be considered for reimbursement when the service was discontinued prior to placement of the device or implant and an appropriate modifier indicating a discontinued procedure is appended. Applicable device and implant codes are defined in the OCE HCPCS data file. Devices, implants, or brachytherapy sources with OCE Status Indicator H (pass-through device) or U (brachytherapy sources) will be denied if reported without a procedure with OCE Status J1, S, or T on the same date of service and same claim.

Applicable codes: see OCE HCPCS data file
Pass-through (H) or brachytherapy source (U) codes require accompanying procedure with OCE Status J1, S, or T

Key Definitions

Implant definition — inv-09

Policy definition (FDA applied)A device placed into a surgically or naturally formed cavity intended to remain implanted continuously for 30 days or more

Revenue-line requirement (outpatient)When an implant revenue code is billed for outpatient services, a HCPCS code that meets this FDA implant definition must be reported or the implant revenue-line will not be reimbursed

Inpatient verificationFor inpatient services, medical records may be requested to verify the FDA implant definition; if not met, the implant revenue-line will not be reimbursed

ScopeFDA product classification guidelines are applied to both inpatient and outpatient hospital services under this policy

Absorbable materials and liquids — inv-10

Policy treatment

Policy Summary

PayerUnitedHealthcare

PolicyReporting and reimbursement of devices, implants, and skin substitutes for outpatient and inpatient hospital services

Policy CodePolicy 2026R5019C

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit device or implant codes on the same claim and date of service as device-dependent procedures or the procedure will be denied.

SourceLink

On This Page

Denial Risk

Skin substitute product submission requirement

When a skin substitute application or replacement procedure is billed, the associated skin substitute product HCPCS code must be submitted on the same claim and for the same date of service. Skin substitute application or replacement procedures identified in the OCE will be denied when an associated skin substitute product identified on the OCE is not submitted for the same date of service and on the same claim. Applicable skin substitute product codes are defined in the OCE HCPCS data file.

Submit skin substitute product HCPCS on same claim and date of service as application/replacement procedure
Missing product code will result in denial when OCE identifies the product as required

Billing Rule

HCPCS required with implant revenue code (outpatient)

For outpatient services, when an implant revenue code is billed, a HCPCS code that meets the FDA definition of an implant (intended to remain implanted continuously for 30 days or more unless otherwise determined by the Commissioner) must be reported. If a HCPCS code is not submitted or the submitted HCPCS does not meet the FDA implant definition, the claim line with the implant revenue code will not be reimbursed. For inpatient services, medical records may be requested to verify that the item meets the FDA implant definition; if it does not, the implant revenue code line will not be reimbursed.

Outpatient implant revenue codes require a HCPCS code that meets FDA implant definition or line will be denied
Inpatient implant revenue codes may trigger medical record request to verify FDA implant definition

Materials and liquids absorbed by surrounding tissue (e.g., hemostats, sealants, bone putty) are considered part of the procedure and not reimbursed as implants

ExamplesAdvanced hemostats and sealants, synthetic sealants, topical absorbable hemostats and topical thrombins, bone morphogenetic protein, bone putty or cement

Other items notedCatheters, staples, and clips when absorbed or integral as described are not reimbursed as implants

Supply/instrument exclusionSupplies or instruments intended to be removed or discarded during the same procedure or episode of care are not considered implants and are not reimbursed as implants