CurrentlongevityhealthplanofcoloradoPolicy UM.045

Skin Substitute Grafts/Cellular and Tissue-Based Products (CTPs)

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This policy governs coverage criteria, documentation requirements, application limits, and product-specific indications for skin substitute grafts/CTPs used to treat chronic wounds (primarily diabetic foot ulcers and venous leg ulcers) for Longevity Health Plan of Colorado members.

Policy Summary

PayerLongevity Health Plan of Colorado

PolicySkin Substitute Grafts/Cellular and Tissue-Based Products (CTPs)

Policy CodePolicy UM.045

Change TypeNo material changes in this revision

Effective Date

Next Review Date

Key ActionObtain prior authorization and provide documentation showing at least 4 weeks of failed standard of care before requesting skin substitute graft/CTP; include wound measurements and evidence of SOC such as offloading or compression.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

8max apps / episode

4mean apps to heal

12-16 wkepisode duration

multiplecovered product lists

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CurrentlongevityhealthplanofcoloradoPolicy UM.045

Skin Substitute Grafts/Cellular and Tissue-Based Products (CTPs)

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Policy Summary

PayerLongevity Health Plan of Colorado

PolicySkin Substitute Grafts/Cellular and Tissue-Based Products (CTPs)

Policy CodePolicy UM.045

Change TypeNo material changes in this revision

Effective Date

Next Review Date

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

8max apps / episode

4mean apps to heal

12-16 wkepisode duration

multiplecovered product lists

~150+non-covered products

Coverage Criteria for Skin Substitutes / CTPs

Continuation therapy and episode limits

Continuation and limits

Continuation and maximums: Further applications are allowed only when documentation demonstrates progression of wound closure under the current treatment plan; requests for more than 4 applications require a provider attestation that medical necessity criteria have been met; the maximum permitted is 8 applications per episode (episode = 12–16 weeks).>4 applications requires attestation

Absence of required attestation will result in denial of additional applications; >8 applications within an episode are considered not reasonable and necessary.

Covered Products (DFU & VLU)

Covered Products — DFU & VLU (selected examples shown in this section)

Covered products list: Selected skin substitute products identified as covered for DFU and VLU include (examples from the document): Kerecis Omega3 (including MariGen shield), NuShield, Oasis wound matrix, PriMatrix, and Theraskin. Coverage is product-specific and tied to the evidence base supporting each product's use for DFU/VLU.

Providers should expect that covered products are supported by higher-certainty clinical evidence and may require prior authorization per payer process.

Non-Covered Products (DFU & VLU)

Non-Covered Products — DFU & VLU

Non-covered products list: Numerous specific named skin substitute products are designated as not covered for DFU and VLU due to lack of published peer‑reviewed evidence, insufficient evidence, or evidence limited to other indications (examples: Ac5 advanced wound system, Acesso dl/tl, AlloDerm (insufficient evidence for DFU/VLU), Amnio‑series products, many others listed in the document). These products will not be covered for any condition unless additional supportive research is released.

Individual product entries in the source include brief evidence notes (e.g., 'No literature found', 'Insufficient evidence', or citation types) that inform the non‑coverage decision.

Coverage for skin substitute grafts/CTPs is limited by application frequency and clinical response. Specifically, > 8 applications within a single episode of care (up to 12–16 weeks) are considered not reasonable and necessary and will be denied. Repeat applications after an unsuccessful prior application are also not covered; an unsuccessful treatment is defined as an increase in ulcer size or depth, no measurable change from baseline, or absence of improvement (no granulation, epithelialization, or progress toward closure). In addition, further applications beyond the initial course are only permitted when documentation demonstrates clear progression of wound closure under the current plan and, per prior authorization rules, requests for more than 4 applications require provider attestation.

Products that lack published, peer‑reviewed evidence demonstrating effectiveness for chronic diabetic foot ulcers (DFU) or venous leg ulcers (VLU) are excluded from coverage. The policy lists numerous named products for which no literature was found or for which evidence was judged insufficient; these products "will not be covered for any condition unless additional and more supportive research is released supporting their use." Providers seeking coverage for such products must supply new, high‑quality peer‑reviewed evidence to change the coverage determination.

The policy specifies groups of products and product forms that are not medically necessary for ulcer care. All liquid or gel skin substitute products/CTP intended for ulcer management are explicitly listed as not reasonable and necessary. In addition, the document enumerates specific named skin substitutes that lack supportive literature and are therefore non‑covered for DFU and VLU; use of these non‑covered products for any condition is not supported unless new, robust evidence is published. Applications placed on infected, ischemic, or necrotic wound beds are also excluded from coverage.

When the document classifies a product with the phrases "Insufficient evidence" or "No literature found" for DFU/VLU, that classification is treated as indicating the product is not supported for medical necessity for these indications. Such evidence classifications are used to inform the non‑coverage list and to justify denial of coverage absent new, peer‑reviewed studies demonstrating safety and effectiveness for chronic wound treatment.

Product Coding and Limits

Product-specific covered and non-covered indicationsmixed

Affinity	Indications = DFU; Non-covered = VLU, Pressure Injuries, Arterial Wounds
AmnioBand, Guardian	Indications = DFU, VLU; Non-covered = Pressure Injuries, Arterial Wounds
Apligraf (GraftSkin)	Indications = DFU, VLU; Non-covered = Pressure Injuries, Arterial Wounds
DermACELL (awm, porous)	Indications = DFU; Non-covered = VLU, Pressure Injuries, Arterial Wounds
Derma-Gide	Indications = DFU; Non-covered = VLU, Pressure Injuries, Arterial Wounds
Dermagraft	Indications = DFU, VLU; Non-covered = Pressure Injuries, Arterial Wounds
Epicord	Indications = DFU; Non-covered = VLU, Pressure Injuries, Arterial Wounds
Epifix	Indications = DFU, VLU; Non-covered = Pressure Injuries, Arterial Wounds
FlexHD / AllopatchHD	Indications = DFU; Non-covered = VLU, Pressure Injuries, Arterial Wounds
Kerecis Omega3 / Kerecis omega3, MariGen shield	Indications = DFU; Non-covered = VLU, Pressure Injuries, Arterial Wounds

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Maximum applications per episode — key thresholds

Maximum applications per episodeUp to 8 applications of a skin substitute graft/CTP are allowed within a single episode of care (episode = 12–16 weeks).

Mean applications associated with healingMean number of applications associated with wound healing is 4; additional applications beyond 4 require documentation and attestation.

Attestation requirementUse of greater than 4 applications requires a provider attestation demonstrating medical necessity; absence of attestation will result in denial of additional applications.

Episode of skin replacement therapy — definition

Episode definitionAn episode of skin replacement therapy is defined as 12 to 16 weeks from the first application of a skin substitute graft/CTP.

Usual duration

Provider Requirements, Documentation, and Denial Triggers

Prior Authorization

Prior authorization and attestation required for episodes

Prior authorization is required for skin substitute graft/CTP episodes. The episode is defined as 12–16 weeks from first application with a maximum of 8 applications per episode. Use >4 applications requires a provider attestation that medical necessity and requirements have been met; in the absence of this attestation, additional applications will be denied.

Episode defined as 12 to 16 weeks; usual episode 12 weeks, may extend to 16 with documentation of progression.
Maximum 8 applications per episode; mean healing associated with 4 applications.
Attestation required when requesting more than 4 applications; absence of attestation leads to denial.

Note

Product-specific coverage — expect product-level prior authorization review

Coverage decisions are made on a product-by-product basis tied to the available evidence. Providers should expect prior authorization review to consider the product’s evidence classification and may require additional documentation to support use.

Definitions and Standard of Care Components

Standard of Care (SOC) components

DebridementProper debridement to a clean granular base prior to graft application.

Infection controlControl of infection with removal of foreign body or focus of infection before placement.

Offloading for DFUDocumented evidence of offloading for diabetic foot ulcers (DFUs).

Compression for VLUDocumented evidence of sustained compression dressings for venous leg ulcers (VLUs).

Moisture and exudate managementAppropriate exudate management to maintain a moist wound environment as part of SOC before and during therapy.

Episode of skin replacement therapy — duration and max applications

Background on Skin Substitutes / CTPs

Skin substitute grafts and cellular/tissue‑based products (CTPs) are used as adjunctive therapies for chronic wounds—most commonly diabetic foot ulcers (DFU) and venous leg ulcers (VLU)—when standard of care measures fail to produce progress. Effective adjunctive use requires prior and concurrent application of standard of care (SOC) measures, including proper debridement to a clean granular base, infection control, documented offloading for DFU, sustained compression for VLU, and management of exudate and systemic factors that impede healing. Coverage is tied to documentation that these SOC elements were applied for at least 4 weeks with serial measurements before grafting, and that the patient remains under care for underlying disease processes contributing to the wound.

Policy Revision History

unspecified (multiple entries)change_log_populatedLatest

Document contains an extensive change log with many placeholder entries indicating prior revisions or slots for dated changes.

Policy Summary

PayerLongevity Health Plan of Colorado

PolicySkin Substitute Grafts/Cellular and Tissue-Based Products (CTPs)

Policy CodePolicy UM.045

Change TypeNo material changes in this revision

Effective Date

Next Review Date

SourceLink

On This Page

The usual episode of care is 12 weeks; up to 16 weeks may be allotted when documentation shows progression of wound closure under the current treatment plan.

Application cap within episodeMaximum of 8 applications permitted within the defined 12–16 week episode.

Certain products are explicitly listed as covered for DFU & VLU (examples include Kerecis Omega3, NuShield, Oasis, PriMatrix, Theraskin).
Many named products are designated non-covered due to 'No literature found' or 'Insufficient evidence' and will not be covered absent new supportive research.

Step Therapy

Require documented ≥4 weeks of SOC before graft application

Apply a skin substitute graft/CTP only after documented failure or stalled response to at least 4 weeks of standard of care (SOC). SOC must continue during graft therapy and include required measures such as debridement and offloading or sustained compression as appropriate.

Document baseline and serial ulcer measurements: initial, pre-SOC, weekly SOC, post-SOC after ≥4 weeks, at initial graft placement, and before each subsequent placement.
Continuous compression for VLU and offloading for DFU must be documented for the episode of care.

Documentation Required

Required clinical documentation in the medical record

The medical record must document prior ulcer interventions that failed, updated medication history, pertinent comorbidities, and the rationale and risks for the chosen skin substitute graft/CTP.

Document interventions that failed during prior ulcer management and review procedure risks/complications.
Confirm the patient is under care for systemic disease processes etiologic for the wound (e.g., diabetes, venous insufficiency, neuropathy).
Include baseline and serial wound measurements as specified (pre-SOC, weekly SOC, post-SOC, at graft placement, before subsequent placements).

Documentation Required

Document product sizing, single‑layer application, and avoidance of wastage

Document efficient, size-appropriate use of the product and avoidance of excessive wastage. The graft must be applied as a single layer per label instructions and not overlapped or applied to adjacent intact skin.

Use the most appropriate product size available consistent with wound size to minimize discarded product.
Apply graft in a single layer without overlay of product or adjacent skin, following label application techniques.

Documentation Required

Support coverage requests with evidence-based documentation

Use the document’s evidence classifications when justifying coverage: show robust, peer‑reviewed literature for products claimed to be supported. Products classified with 'No literature found' or 'Insufficient evidence' are not supported for DFU/VLU.

Evidence statements in the policy (e.g., 'No literature found', 'Insufficient evidence') are used to classify products and drive coverage decisions.
Documentation submitted to support coverage should reference published, peer‑reviewed studies demonstrating effectiveness in chronic DFU/VLU.

Denial Risk

Limits and denial triggers — attestation and hard maximums

Requests for more than 4 applications require a provider attestation; failure to provide the attestation will result in denial. More than 8 applications within an episode (12–16 weeks) will be denied.

>4 applications: provider attestation showing requirements met and medical necessity.
>8 applications per episode are considered not reasonable and necessary and will be denied.

Denial Risk

Denial triggers: clinical contraindications (infection, ischemia, necrosis, uncontrolled comorbidities)

Applications will be denied if placed on an infected, ischemic, or necrotic wound bed, or when the patient has inadequate control of underlying conditions or other listed contraindications (e.g., progressive necrosis, active Charcot arthropathy, active vasculitis).

Placement on infected, ischemic, or necrotic wound bed is specifically excluded.
Patients with inadequate control of underlying conditions or listed contraindications are not candidates for coverage.

Denial Risk

Denial risk for products classified as non‑covered

Products listed as 'Non‑Covered' for DFU & VLU in the policy will not be covered for any condition unless additional supportive research is published and provided to justify coverage.

Non‑covered products are identified with evidence notes (e.g., 'No literature found', 'Insufficient evidence').
Absent new supportive peer‑reviewed research, coverage for these products will be denied.

Note

Miscellaneous required provider actions — consolidate documentation, SOC, evidence, and attestation

Ensure documentation addresses any additional provider actions required by the policy: include serial wound measurements, SOC continuation, evidence citations for the chosen product, efficient product sizing and single‑layer application, and provider attestation when applicable.

Serial measurements and SOC documentation (pre‑SOC, weekly SOC, post‑SOC after ≥4 weeks, at graft placement, before each subsequent placement).
Evidence citations for product support if claiming a covered indication.
Attestation when requesting >4 applications; observe max 8 applications per episode.

Episode durationDefined as 12 to 16 weeks from the first application of a skin substitute graft/CTP.

Maximum applicationsMaximum of 8 applications permitted per episode (12–16 weeks).

Usual vs extended durationUsual episode = 12 weeks; extension to 16 weeks requires documentation demonstrating continued progression of wound closure.

Non-Covered Products (DFU & VLU) — definition

Definition of Non-Covered Products (DFU & VLU)Products designated as 'Non-Covered' are those that have not been shown effective at treating chronic wounds (DFU/VLU) based on available published, peer-reviewed literature.

Evidence basisEntries include evidence notes such as 'No literature found' or 'Insufficient evidence' to justify non-coverage decisions.

Coverage consequenceThese products will not be covered for any condition unless additional, more supportive research is released supporting their use.

Examples providedThe policy lists specific named products (e.g., Ac5 advanced wound system, Acesso dl/tl, Activate matrix, AlloDerm, Allogen) with associated evidence comments to indicate non-coverage status.