CurrentUnitedHealthcarePolicy 2025F7024D

Device and Skin Substitutes with Associated Procedures

Defines UnitedHealthcare coding and claim submission requirements for devices and skin substitutes associated with outpatient hospital procedures, including device credit reporting and state exceptions; affects outpatient hospital providers submitting UB-04 claims.

Policy Summary

PayerUnitedHealthcare

PolicyDevice and Skin Substitutes with Associated Procedures

Policy CodePolicy 2025F7024D

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionSubmit the device or skin substitute product on the same claim and date of service as the associated procedure to avoid denial.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Device-dependent denialdenial rule

Low/High matchskin substitute categories

49/50/53/FDdevice credit reporting codes

FB/FCdevice credit modifiers

NCstate-specific applicability

Submission and Denial Rules

Submission and Denial Criteria for Devices, Skin Substitutes, and Device Credit

Submission and denial criteria for device-dependent procedures, skin substitute applications, and device credit reporting.

ALL of the following

ALL of the following
- The procedure includes the applicable device on the same claim and the same date of service.
  Per policy, a device-dependent procedure will be denied if reported without an applicable device on the same claim and date of service.
- EXCEPTION: Reimbursement may be considered if the service was discontinued prior to placement of the device and the procedure code is appended with an appropriate modifier indicating the procedure was discontinued.
  The applicable device and modifier guidance are defined in the OCE HCPCS data file.
ALL of the following

Policy Summary

PayerUnitedHealthcare

PolicyDevice and Skin Substitutes with Associated Procedures

Policy CodePolicy 2025F7024D

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionSubmit the device or skin substitute product on the same claim and date of service as the associated procedure to avoid denial.

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

ALL of the following

When a device was obtained by the provider at no cost or at a reduced cost, it must be submitted with the appropriate condition code, value code, and modifier to report device credit.
Condition codes (report as applicable): Condition code 49 (Product Replacement within Product Lifecycle); Condition code 50 (Product Replacement for Known Recall); Condition code 53 (Initial placement of a medical device provided as part of a clinical trial or free sample).
ALL of the following
- Value Code FD (Credit Received from the Manufacturer for a Medical Device) must be reported when credit was received.
Modifiers (report as applicable): Modifier FB (items without cost to provider or full credit received) or Modifier FC (partial credit for replaced device).

Codes and Cost-Category Requirements

Skin substitute high proceduresCPTCovered

15271	Skin substitute high procedure (listed)
15272	Skin substitute high procedure (listed)
15273	Skin substitute high procedure (listed)
15274	Skin substitute high procedure (listed)
15275	Skin substitute high procedure (listed)
15276	Skin substitute high procedure (listed)
15277	Skin substitute high procedure (listed)
15278	Skin substitute high procedure (listed)

Device credit codes and modifiersmixed

49	Condition code: Product Replacement within Product Lifecycle--Replacement of a product earlier than the anticipated lifecycle.
50	Condition code: Product Replacement for Known Recall of a Product--Manufacturer or FDA has identified the product for recall and therefore replacement.
53	Condition code: Initial placement of a medical device provided as part of a clinical trial or free sample-Code is for outpatient claims that have received a device credit upon initial medical device placement in a clinical trial or a free sample.
FD	Value Code: Credit Received from the Manufacturer for a Medical Device
FB	Modifier: Items without cost to provider, supplier, or practitioner, or full credit received for replaced device (examples, but not limited to, covered under warranty, replaced due to defect, free examples).
FC	Modifier: Partial credit for replaced device.

Skin substitute cost-category match requirement

RequirementLow-cost skin substitute products must be submitted only with skin substitute application/replacement procedures that OCE identifies as low-cost; high-cost products must be submitted only with procedures OCE identifies as high-cost.

Claim timingThe skin substitute product must be submitted on the same claim and for the same date of service as the associated application or replacement procedure.

Denial consequenceA skin substitute procedure will be denied when the product category (low vs. high) does not match the procedure category or the product is not submitted on the same claim/date.

Billing and Reporting Requirements for Providers

Denial Risk

Device-dependent procedure submission — submit device on same claim and same date of service

When the use of a device is necessary in the performance of certain procedures, the device must be submitted on the same claim and for the same date of service as the procedure. A device-dependent procedure will be denied if reported without an applicable device on the same claim and date of service. A procedure submission without a device may be considered for reimbursement only when the service was discontinued prior to device placement and the procedure is appended with an appropriate modifier indicating it was discontinued. Applicable device and procedure codes are defined in the OCE HCPCS data file.

Applicable codes defined in the OCE HCPCS data file.

Denial Risk

Skin substitute product submission — submit skin substitute product on the same claim and date of service

When a skin substitute application or replacement procedure is reported, the associated skin substitute product must be submitted on the same claim and for the same date of service. Skin substitutes are categorized in the OCE as low-cost or high-cost; the product submission must match the cost category of the application/replacement procedure. Application/replacement procedures identified as low-cost will be denied if a low-cost skin substitute product is not submitted on the same claim and date of service. Likewise, procedures identified as high-cost will be denied if a high-cost product is not submitted on the same claim and date of service.

Billing Rule

Device credit reporting — when device obtained at no or reduced cost, report condition codes (49, 50, 53), value code FD, and modifier FB or FC as applicable.

When a device was obtained by the provider at no cost or at a reduced cost, report the device credit on the claim using the appropriate condition code(s), value code, and modifier so reimbursement accurately reflects the credit received. Failure to report device credit information may affect payment.

Condition code 49: Product Replacement within Product Lifecycle.
Condition code 50: Product Replacement for Known Recall of a Product.
Condition code 53: Initial placement of a medical device provided as part of a clinical trial or free sample (outpatient claims).
Value Code FD: Credit Received from the Manufacturer for a Medical Device.
Modifier FB: Items without cost to provider or full credit received for replaced device (e.g., warranty replacement, defect, free sample).
Modifier FC: Partial credit for replaced device.

Key Terms

Device-dependent procedure — definition and billing rules

DefinitionA device-dependent procedure is a procedure for which use of a device is necessary; the device must be submitted on the same claim and for the same date of service as the procedure.

Billing requirementSubmit the applicable device on the same claim and same date of service as the device-dependent procedure; applicable codes are defined in the OCE HCPCS data file.

Denial conditionThe procedure will be denied if reported without an applicable device on the same claim and date of service unless the service was discontinued prior to device placement and an appropriate modifier is appended.

Skin substitute low/high — definition

DefinitionSkin substitute products are assigned two OCE categories: low-cost and high-cost; the product category must match the associated procedure category on the same claim and date of service.

Source of categorizationApplicable skin substitute procedure and product codes and their cost categories are defined in the CMS OCE HCPCS data file.

Submission timingThe associated skin substitute product must be submitted on the same claim and for the same date of service as the application or replacement procedure.

Device credit reporting — required codes and modifiers

When to reportWhen a device was obtained at no cost or a reduced cost, report the appropriate condition code, value code, and modifier to document device credit.

Condition codesUse condition code 49 (Product Replacement within Product Lifecycle), 50 (Product Replacement for Known Recall), or 53 (Initial placement of device in clinical trial/free sample) as applicable.

Value codeReport Value Code FD to indicate credit received from the manufacturer for a medical device.

ModifiersUse modifier FB to indicate items without cost to provider or full credit received; use modifier FC to indicate partial credit for a replaced device.