ModifiedEmblemHealthPolicy N/A

Coding Guidelines: Device, Implant and Skin Substitutes (Facilities)

Governs coding and billing requirements for facilities (UB04) for devices, implants, and skin substitutes across commercial, Medicare, and Medicaid products; affects hospitals and facility billing staff and applicable clinicians submitting facility claims.

Policy Summary

PayerEmblemHealth

PolicyCoding Guidelines: Device, Implant and Skin Substitutes (Facilities)

Policy CodePolicy N/A

Change TypeCode additions and CMS payment methodology update

Effective DateN/A

Next Review DateN/A

Key ActionBill devices and implants on the same claim and date of service with the associated procedure or the claim will deny.

SourceLink

POLICY UPDATE CHANGES

New HCPCS and G‑codes applicable to Medicare only were added (A2040–A2045, G0681–G0684) and noted as effective 4/1/2026 in the revision history.

CMS eliminated the 'high-cost/low-cost' product categorization and replaced it with a standardized flat national payment rate per square centimeter effective January 1, 2026.

Multiple new codes were added effective 1/1/2026 (e.g., C9811–C9817 and several procedure codes) and other codes were deleted per 1/1/2026 updates.

30+pages/chunks of device-to-procedure code mappings present in document portion

C1889recommended HCPCS code for NOS implantable/insertable devices

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CMS moved to flat national payment rate per sq cm for skin substitutes

636skin substitutes billed under revenue code

A2040–A2045HCPCS codes applicable to Medicare only

Coverage Criteria for Devices, Implants, and Skin Substitutes

Facility device/implant billing criteria and exceptions

Stipulations that determine whether device/implant charges will be reimbursed separately or packaged and requirements for valid billing:

If an outpatient or inpatient claim includes an implant revenue code, an appropriate HCPCS code corresponding to the FDA definition of an implant must be reported or the claim line will deny.

Medical records may be requested to validate that the item meets the FDA implant definition when inpatient implant revenue codes are used.

Devices reported without a specific HCPCS should be reported using HCPCS C1889 (Implantable/insertable device, not otherwise classified) and include charges; such devices must meet the documented C1889 use criteria (FDA authorization/IDE or appropriate exemption, integral to the service, single‑patient use, contact with human tissue, surgically implanted/inserted, and not depreciable equipment or routine supply).

Only HCPCS codes with OPPS status indicator 'H' are eligible for separate reimbursement under Medicare or contracts that follow Medicare methodology; items with status indicator 'N' are packaged into the APC/Inpatient payment unless contractually specified otherwise.

When a procedure requires a device or implant, the procedure and device/implant must be billed on the same claim with the same date of service; failure to bill together will result in return or denial of the claim.

Non‑reimbursable examples (not all‑inclusive): Certain supplies, instruments and miscellaneous items (for example: synthetic sealants, topical absorbable hemostats, topical thrombins, bone morphogenetic proteins, bone putty/cement, staples, clips) are considered part of the procedure and are not separately payable.

A code listed as device‑dependent or on an HCPCS table does not by itself constitute coverage or payment entitlement.

Coverage and billing rules for devices, implants and skin substitutes

Coverage and billing stance for specific items:

Absorbable materials, liquids and other closure methods (including synthetic sealants, advanced hemostats, topical thrombins, bone putty/cement, staples, and clips) are considered part of the inpatient or outpatient hospital service and are not separately payable.

A skin substitute application or replacement procedure must be billed on the same claim and same date of service as the coinciding skin substitute product; skin substitutes are billed under revenue code 636.

Autografts are not eligible for separate reimbursement; the cost for harvest and preparation is included in the procedure charge.

The HCPCS codes A2040–A2045 and G0681–G0684 are identified as applicable to Medicare only and are not reimbursable by Commercial or Medicaid plans unless the contract follows Medicare methodology.

Effective January 1, 2026 CMS replaced the prior high/low product categorization with a standardized flat national payment rate per square centimeter for skin substitutes; EmblemHealth follows this for Medicare Advantage and for Commercial contracts that follow Medicare reimbursement methodology.

Billing and reimbursement criteria

Requirements for billing and reimbursement of skin substitutes and implants for facility settings:

The skin substitute product must be billed on the same claim and same date of service as the coinciding application/replacement procedure; skin substitute products are billed under revenue code 636.

Low‑cost skin substitute application procedure codes (e.g., C5271–C5278) must be reported with a matching low‑cost product on the same claim and same date of service or the claim will be denied.

High‑cost skin substitute application procedure codes (e.g., 15271–15278, 15777) must be reported with a matching high‑cost product on the same claim and same date of service or the claim will be denied.

CPT/HCPCS codes not included on the applicable Medicaid fee schedule(s) will be denied.

Effective January 1, 2026 CMS replaced the high/low categorization with a standardized flat national payment rate per square centimeter for skin substitutes; this change applies to EmblemHealth Medicare Advantage and Commercial contracts that follow Medicare methodology.

Coding, HCPCS/CPT, and Payment Methodology

OPPS status indicators referencedmixed

H	OPPS status indicator H — pass-through device payment; eligible for separate reimbursement
N	OPPS status indicator N — packaged into APC/Inpatient payment

NOS implant HCPCSHCPCSCovered

C1889

Implantable/insertable device, not otherwise classified — to report devices without specific HCPCS

Device dependent procedure mappingsmixed

multiple CPT/HCPCS mappings

Large list of device-dependent procedure code mappings (examples shown across chunks 18-22)

HCPCS/C-code device mappingsHCPCS

numerous C-codes and L/V codes

Device dependent HCPCS/C codes mappings and device lists (fragments present)

Medicare-only HCPCS (examples)HCPCSNot Covered

A2040-A2045, G0681-G0684

HCPCS codes identified as applicable to Medicare only and not reimbursable by Commercial or Medicaid plans.

Medicare-only HCPCS/G codesHCPCS

A2040–A2045, G0681–G0684

HCPCS/G codes listed as applicable to Medicare only (new codes listed)

Low-cost skin substitute proceduresCPT | HCPCSCovered

C5271–C5278

Application of low-cost skin substitute graft codes (various anatomic sites and size increments)

High-cost skin substitute proceduresCPTCovered

15271–15278, 15777

Application of high-cost skin substitute grafts and biologic implant implantation codes

FDA implant duration threshold

FDA implant duration thresholdDevice placed into a surgically or naturally formed cavity intended to remain for 30 days or more (FDA definition); FDA may deem shorter-duration devices as implants in some cases.

Post‑procedure retentionImplants must remain in the patient’s body upon discharge from the inpatient stay or outpatient procedure.

Not an implantSupplies or instruments removed or discarded during the same procedure or episode of care are not considered implants.

CMS payment methodology change

Applicability

Billing and Documentation Requirements for Providers

Billing Rule

Claim bundling and same-claim requirement

Devices and/or implants with OCE Status Indicator H must be billed on the same claim and same date of service as the associated procedure (OCE Status J1, S, or T). If the procedure and device are not billed together on the same claim and date of service, the claim will be returned or will deny.

Applicable to devices/implants that are pass-through (OCE Status H).
Associated procedure must have OCE Status J1, S, or T.

Documentation Required

Documentation may be requested to confirm FDA implant definition

Medical records may be requested to confirm that a billed implant meets the FDA definition of an implant (a device intended to remain in the body for 30 days or more). If the appropriate HCPCS that corresponds with the FDA implant definition is not submitted or does not meet the definition, the implant revenue line will deny.

Definitions and Operational Notes

Implant (FDA definition)

Definition (short)An implant is a device placed into a surgically or naturally formed cavity intended to remain for 30 days or more per FDA.

ExamplesMay include metal anchors, artificial joints, pins, plates, radioactive seeds, metal screws, shunts, stents, and some allografts.

ValidationIf an implant revenue code is billed, an appropriate HCPCS that meets the FDA implant definition must be reported or the claim line will deny; medical records may be requested.

Use criteria for C1889-reportable devices

FDA/IDE requirementDevice must have FDA marketing authorization or an FDA investigational device exemption (IDE) or another appropriate FDA exemption to qualify for reporting under C1889.

Clinical use criteria

Policy Summary

PayerEmblemHealth

PolicyCoding Guidelines: Device, Implant and Skin Substitutes (Facilities)

Policy CodePolicy N/A

Change TypeCode additions and CMS payment methodology update

Effective DateN/A

Next Review DateN/A

Key ActionBill devices and implants on the same claim and date of service with the associated procedure or the claim will deny.

SourceLink

On This Page

Vendor invoice documentation may be required for billed charges on revenue codes 278 and/or 279; missing, non‑matching, or unclear units on the invoice will result in denial. Provider storage/delivery costs and certain waste situations (items opened by mistake, not used, contaminated, case cancelled, technical failure, bulk purchases without appropriate units) are not reimbursable.

Operational note: Autografts are not separately reimbursable; harvest and preparation are included in the procedure charge.

Change applies to EmblemHealth Medicare Advantage plans and to Commercial contracts that follow Medicare reimbursement methodology.

Packaging impactProducts that do not qualify for OPPS pass-through are packaged into OPPS payment for the associated application procedure under the new methodology.

Flat national payment rate effective date

Effective dateStandardized flat national payment rate per square centimeter effective January 1, 2026.

Pre‑2026 guidancePrior to Jan 1, 2026, CMS categorized skin substitutes as low- and high-cost products per the OCE HCPCS data file.

Denial risk noteCPT/HCPCS codes not included on Medicaid fee schedules will be denied under the updated methodology.

Implants must remain in the patient's body upon discharge to meet the definition.
Failure to submit an appropriate HCPCS that meets the FDA implant definition will result in denial of the revenue line.

Billing Rule

Skin substitute billing

A skin substitute application or replacement procedure must be billed on the same claim and same date of service as the skin substitute product, and skin substitutes are billed under revenue code 636. Autografts are not eligible for separate reimbursement.

Bill product and application/replacement on same claim and same DOS.
Use revenue code 636 for skin substitute products.
Autograft harvest/preparation costs are included in the procedure charge and not separately payable.

Billing Rule

Claim submission and billing requirement

Report the skin substitute product and the coinciding application or replacement procedure on the same claim and the same date of service; failure to do so may result in denial. Skin substitutes are billed under revenue code 636.

Ensure product and procedure line items share the same date of service on the UB04.
Autografts should not be billed separately.

Denial Risk

Product/procedure matching requirement

Low-cost and high-cost skin substitute application procedures must be reported with a matching product (low-cost with low-cost; high-cost with high-cost) on the same date of service and on the same claim, or the claim will be denied.

Low-cost procedures (e.g., C5271–C5278) require a low-cost product on same claim/DOS.
High-cost procedures (e.g., 15271–15278) require a high-cost product on same claim/DOS.
Codes not on the Medicaid fee schedule will be denied.

Documentation Required

Invoice and documentation requirements for implants/supplies

Vendor invoices may be required for billed charges on revenue codes 278 and/or 279 to verify the implants used correspond to the services rendered; missing, non-matching, or unclear units on the invoice will result in denial. Provider storage/delivery costs and certain waste situations are not reimbursable.

If implants were purchased in bulk, the units applicable to the billed claim must be noted on the invoice.
Situations constituting non-reimbursable waste include items opened by mistake, unused items, equipment failure, case cancellation, contaminated items, and inappropriate large-quantity purchases.
Provider storage/delivery costs are not reimbursable.

Device must be integral to the service furnished, used for one patient only, come in contact with human tissue, and be surgically implanted or inserted.

ExclusionsItem must not be depreciable equipment or routine supply (e.g., suture, customized surgical kit, scalpel, clip) to qualify for C1889 reporting.

HCPCS codes not meeting FDA implant definition

Non‑implant examplesThe policy provides an examples table of HCPCS codes that do not meet the FDA implant definition (not all-inclusive); see listed HCPCS examples in the document.

Purpose of listExamples illustrate codes that should not be billed as implants even when reported on implant revenue lines.

Not exhaustiveThe table is explicitly noted as not an all-inclusive list; providers should validate implant status against FDA criteria.

Absorbable/liquid closure methods

Non-reimbursable materialsAbsorbable materials and liquids (synthetic sealants, advanced hemostats, topical thrombins, bone putty/cement, staples, clips) are not separately payable and are considered part of the inpatient/outpatient hospital service.

Absorbed materialsAny liquids or materials absorbed by surrounding tissue are considered part of the implant procedure and non-reimbursable.

ExamplesIncludes synthetic sealants, bone morphogenetic protein, topical absorbable hemostats, topical thrombins, bone putty or cement.

OPPS payment packaging for skin substitute products

OPPS packaging policyEmblemHealth follows CMS: skin substitute products that do not qualify for OPPS pass-through status are packaged into the OPPS payment for the associated skin substitute application procedure.

Pre-/post‑2026 categorizationPrior to Jan 1, 2026 CMS categorized products as low‑ and high‑cost; that categorization was replaced by the flat per sq cm payment effective 1/1/2026.

Applicability to settingsPackaging guidance applies to OPPS, ASC, and other ambulatory payment methodologies.

Revenue code 636

Revenue code for skin substitutesRevenue code 636 is used to bill skin substitute products.

Claiming requirementSkin substitute product must be billed on the same claim and same date of service as the coinciding application/replacement procedure.

AutograftsAutografts are not eligible for separate reimbursement; harvest and preparation are included in the procedure charge.