CurrentCignaPolicy 0068

Tissue-Engineered Skin Substitutes

Coverage policy for tissue-engineered skin substitutes across multiple indications (breast reconstruction, burns, diabetic foot ulcers, venous stasis ulcers, dural repair, paraesophageal/hiatal hernia repair, parotidectomy) including product-specific criteria, application codes, application limits, and lists of investigational/noncovered products.

Policy Summary

PayerCigna

PolicyTissue-Engineered Skin Substitutes

Policy CodePolicy 0068

Change TypeMultiple product additions/removals and coverage clarifications (material) — see change list

Effective Date

Next Review Date

Key ActionFor diabetic foot and venous stasis ulcers, document ulcer duration, failed standard therapy, HbA1c <12%, and adequate blood supply (palpable pedal pulse or ABI ≥ 0.70).

SourceLink

POLICY UPDATE CHANGES

Removed Marigen™ Pacto from coverage statement

Added Absolv3 Membrane, AmchoMatrixDL, AmnioMatrixF4X, CYGNUS Solo, NuForm, Polygon3 Membrane, Summit AC, Summit FX to EIU policy statement

Differentiated Phasix and Phasix ST in coverage statement and in background

Added policy statement to cover Marigen™ Pacto for diabetic foot ulcers

Added policy statement to cover GRAFIX DUO for diabetic foot ulcers and venous stasis ulcers

Added definition of large hiatal hernia to coverage statement for clarification

Added Acelagraft, Acesso TrifACA, AmnioPlast Double, Apollo FT, Axolotl Graft™ Ultra, InnovaMatrix FD, Natalin, NeoThelium FT, NeoThelium 4L, NeoThelium 4L+, Summit AAA, SurGraft AC, SurGraft ACA to EIU policy statement

Added Allomend and VNEW to EIU policy statement

Clarified Phasix ST mesh is the appropriate type of Phasix mesh for use in paraesophageal/hiatal hernia repair

Added policy statement to cover Galaflex for breast reconstruction

Added policy statement to cover Actigraft and Kerecis for diabetic foot ulcers

Added policy statements to cover multiple products for dural repair

Added policy statement to cover Phasix ST mesh and Gore Bio A for paraesophageal/hiatal hernia repair

Added policy statement to cover Alloderm for use in parotidectomy

Removed Symbotex from the policy

Added multiple new CPT codes for products that are EIU

Removed policy statements for numerous products (unspecified)

Added policy statement of noncoverage for XWrap

Added policy statement of noncoverage for Membrane Wrap and Membrane Graft

Added new CPT code for Matrix HD (listed as EIU)

Revised policy statement to increase the number of initial applications allowed for venous stasis ulcers

Revised policy statement to increase the number of initial applications allowed for diabetic foot ulcers

Revised noncoverage policy statement (unspecified details)

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.

numerousProducts listed (covered/conditional)

severalInvestigational / unproven

multipleIndications covered

100+Products in part

multiple RCTs citedRCT evidence

Coverage Summary & Scope

This policy (Part 1) addresses coverage and medical‑necessity criteria for tissue‑engineered skin substitutes and related biologic/dermal matrices across multiple indications (eg, burn care, diabetic foot ulcers, venous stasis ulcers, breast reconstruction, dural repair, paraesophageal/hiatal hernia repair, parotidectomy). The document lists product‑specific application and product codes, product‑specific application limits, and product‑level determinations. Benefit plan terms supersede this Coverage Policy where conflicts exist, and certain Cigna entities may only perform utilization review rather than make coverage determinations. Coverage stance across products and indications is mixed, with some products considered medically necessary for specified indications and many products considered investigational or lacking sufficient evidence.

Key clinical thresholds

Hemoglobin A1c (DFU/VLU eligibility)< 12%

Ankle-Brachial Index (adequate arterial supply)>= 0.70

Apligraf: ulcer duration (DFU)> 3 weeks

Actigraft: ulcer duration (DFU)> 4 weeks

AlloPatch/AmnioBand/Dermagraft/Integra: ulcer duration (product examples)>= 6 weeks (product-specific)

Venous stasis ulcer duration (common requirement)> 4 weeks

Epicel indication (burns)Total body surface area >= 30%

Medical‑Necessity Criteria

General: Accepted skin grafts

Each of the following skin grafts is considered medically necessary for wound coverage:

autologous skin graft (CPT Codes 15040-15261)

unprocessed allogeneic human (cadaver) skin graft (CPT Codes 15271-15278; HCPCS Code Q4100)

unprocessed xenogeneic pig skin graft (CPT Codes 15271-15278; HCPCS Code Q4100)

Breast reconstruction - general rule

Considered medically necessary when used in association with a covered, medically necessary breast reconstruction procedure.

AlloDerm® (Application CPT/HCPCS: 15777; Product HCPCS: Q4116)

Medically Necessary Products & Indications (Enumerated)

Product entries include guidance on the most applicable application CPT codes (notably 15271–15278 and related CPT ranges) and product HCPCS/Q/C codes. Many product rows list the recommended application CPT/HCPCS codes and the product HCPCS Q‑ or C‑code; product application limits (number of initial and additional applications and time windows) are specified in the Medical‑Necessity Criteria section for ulcer and wound indications.

Evidence Summary & Device‑Specific Indications

Randomized controlled trials exist for a subset of products: multicenter RCTs support Grafix (cryopreserved placental membrane) for partial/full‑thickness diabetic foot ulcers and venous leg ulcers; Integra Dermal Regeneration Template has PMA and a multicenter RCT supporting selected DFU and burn indications; Kerecis (fish‑skin grafts) has multiple 510(k) clearances and recent RCTs showing improved healing rates in non‑healing DFUs. EpiCord and Integra Flowable have RCT data showing improved healing vs comparators in specific populations. Other products (Apligraf, Dermagraft, Biobrane, TransCyte, Epicel) have PMA/HDE or FDA clearance for particular labeled uses supported by trials. Many listed products, however, are HCT/Ps or 510(k) devices with limited peer‑reviewed clinical effectiveness evidence (case series, pilot studies) and remain categorized as experimental/investigational in this policy.

Selected evidence highlights

Apligraf (PMA) - DFU/VLU RCTs/supportPMA-approved for noninfected venous stasis ulcers and full-thickness DFUs; one initial application, up to 4 in 12 weeks if not progressing

Grafix (cryopreserved placental membrane)Multicenter RCTs show improved healing and faster time to closure for partial/full-thickness DFUs; adjunctive benefit for VLUs; insufficient for complex DFUs with exposed bone/tendon

Kerecis (fish skin grafts) - RCT evidenceMultiple RCTs (Lullove 2021; Lantis 2023; Dardari 2024) show higher healing rates vs SOC for nonhealing DFUs, including some penetrating wounds

Coding — Application & Product Codes

When billing, providers must report the most specific product HCPCS / temporary code available (for example, Q-codes, K-codes, or specific permanent HCPCS) together with the associated application CPT code(s) when applicable (e.g., CPT codes 15271-15278 for many skin substitute applications). See provider_actions billing rules for enforcement and documentation requirements.

Application CPT/HCPCS codes referencedCPTCovered

15150-15157	Application for cultured epidermal autograft (Epicel)
15040-15261	Autologous skin grafts
15271-15278	Application codes for unprocessed allogeneic/xenogeneic and many skin substitute products
15275-15278	Application codes for certain skin substitute product applications (e.g., AlloPatch Pliable)
15777	Breast reconstruction application (ADM/scaffold placement)

Product HCPCS / temporary codes referencedHCPCSCovered

Q4100	Allograft/skin substitute — various products (temporary/product-specific Q-code)
Q4104	Integra Matrix Wound Dressing
Q4105	Integra Bilayer Matrix Wound Dressing
Q4108	Integra Meshed Bilayer Wound Matrix
Q4116	AlloDerm
Q4122	DermACELL
Q4128	FlexHD Acellular Hydrated Dermis
Q4182	Transcyte
A2012	Suprathel
C5271	Application/adjunct code referenced with some dermal products

1–10 of 16

1/2

Common HCPCS / product codes (selected)HCPCS

K050337	Product-specific temporary HCPCS code (K-code)
K161221	Product-specific temporary HCPCS code (K-code)
K140306	Product-specific temporary HCPCS code (K-code)
K181094	Product-specific temporary HCPCS code (K-code)
K142070	Product-specific temporary HCPCS code (K-code)
K153756	Product-specific temporary HCPCS code (K-code)
K171231	Product-specific temporary HCPCS code (K-code)
K200502	Product-specific temporary HCPCS code (K-code)
K181330	Product-specific temporary HCPCS code (K-code)
K210024	Product-specific temporary HCPCS code (K-code)

1–10 of 14

1/2

Not-covered / investigational HCPCS listedmixedExperimental

FDA 510(k) (Seamguard)	FDA 510(k) clearance reference for Seamguard (listed for reference)
FDA 510(k) (Strattice)	FDA 510(k) clearance reference for Strattice (listed for reference)
FDA 510(k) (Puraply/Fortaderm)	FDA 510(k) clearance reference for PuraPly/FortaDerm (listed for reference)
FDA 510(k) (SportMesh)	FDA 510(k) clearance reference for SportMesh (listed for reference)

Provider Actions — Documentation, Billing & PA

Documentation Required

Document prior failed standard therapy and wound characteristics

Document that the ulcer/wound has failed an adequate trial of standard wound therapy and record key wound characteristics required by the policy. Required elements include duration of the ulcer (product-specific thresholds apply), documentation of prior standard wound therapy failure (e.g., debridement, off‑loading, compression where applicable), recent hemoglobin A1c when diabetes is present (policy threshold: < 12%), and evidence of adequate arterial perfusion to the treated extremity (palpable pedal pulse or ABI ≥ 0.70; trial-specific perfusion measures such as toe pressures or tcpO2 may be used where noted).

Ulcer duration — document length of time wound has been present and apply product-specific minimums (e.g., >3–6+ weeks depending on product)
Prior standard wound therapy — document failure of SWT (debridement, off‑loading, compression, topical care) before advanced product use
Diabetes control — record HbA1c with policy threshold of < 12%
Perfusion — document palpable pedal pulses OR ABI ≥ 0.70 (trial-specific alternatives such as toe pressures or tcpO2 also acceptable per product)

Medicare Determinations & LCD/NCD References

Policy / LCD/NCD	Effective Date / Note
RECELL PMA BP170122	2018-09-20
Porcine Skin NCD 270.5	longstanding
L36690 (CGS) - Wound Application of CTPs, Lower Extremities	2024-09-05 (rev effective); scheduled to retire 2025-04-12 — consult current Medicare policy
L36377 (First Coast) - Skin Substitute Grafts/CTPs for DFU & VLU	Future effective 2026-01-01 — consult current Medicare policy
L35041 (Novitas) - Skin Substitute Grafts/CTPs for DFU & VLU	Future effective 2026-01-01 — consult current Medicare policy
Note	Consult current Medicare NCD/LCD policies for updates and the most up-to-date determinations

Background, Definitions & Regulatory Context

This Coverage Policy provides clinical criteria and product‑specific guidance to support utilization review and adjudication of tissue‑engineered skin substitutes. It is intended as an interpretive guide for Cigna Companies; where a client benefit plan differs, the plan document governs. Utilization review practices and prior authorization requirements may vary by Cigna entity.

Regulatory context: products are regulated via multiple FDA pathways—PMA for higher‑risk interactive devices (eg, Apligraf, Dermagraft, DuraSeal PMA variants), 510(k) clearance for many wound or reinforcement scaffolds (eg, Kerecis, Integra 510(k) entries, numerous mesh/dural products), and HCT/P (section 361) classification for minimally manipulated human tissue allografts (eg, many amnion/chorion/placental products, AlloDerm). The policy underscores that FDA clearance/approval does not equate to broad peer‑reviewed evidence of clinical effectiveness beyond the cleared indication.

Key definitions

Standard wound therapy (SWT / SOC)Debridement, off‑loading, moist wound care, infection control; customary non-advanced wound care prior to skin substitutes

HCT/PHuman cells, tissues, and cellular or tissue-based products regulated under section 361 and 21 CFR part 1271

CTP

Selected Trial & Systematic Review Highlights

Randomized trials and systematic reviews summarized include: Kerecis fish‑skin RCTs demonstrating improved DFU healing vs standard care (multiple trials including Dardari 2024, Lantis 2023, Lullove 2021); Integra Flowable RCT (Campitiello 2017) showing superior 6‑week healing in selected DFUs; DuraSeal cranial and spine PMA trials showing improved intraoperative closure but mixed postoperative CSF leak results (Osbun et al. 2012; Kim & Wright 2011); Grafix RCTs and multicenter data supporting improved healing in partial/full‑thickness DFUs and VLUs but limited data for complex DFUs; EpiCord RCT (Tettelbach 2018) reporting higher 12‑week healing rates vs alginate dressings. Systematic reviews for biologic meshes and dural sealants note limited high‑quality evidence, heterogeneous results, and wide outcome variability, highlighting need for further RCTs.

Trial highlights

EpiCord (DFU 12-week healing)70% healed vs 48% with alginate (ITT), p=0.0089

Integra Flowable (6-week DFU healing)86.95% vs 52.17% control (p=0.001)

DermACELL (DFU RCT)Significantly higher healed proportion at 16 weeks vs conventional care (p=0.0385)

Grafix RCTs summaryRandomized trials report significantly improved healing and shorter time to healing for partial/full-thickness DFUs and benefit for VLUs; limited for complex DFUs

Revision History

removedLatest

Removed Marigen™ Pacto from coverage statement

addedLatest

Added Absolv3 Membrane, AmchoMatrixDL, AmnioMatrixF4X, CYGNUS Solo, NuForm, Polygon3 Membrane, Summit AC, Summit FX to EIU policy statement

Policy Summary

PayerCigna

PolicyTissue-Engineered Skin Substitutes

Policy CodePolicy 0068

Change TypeMultiple product additions/removals and coverage clarifications (material) — see change list

Effective Date

Next Review Date

Key ActionFor diabetic foot and venous stasis ulcers, document ulcer duration, failed standard therapy, HbA1c <12%, and adequate blood supply (palpable pedal pulse or ABI ≥ 0.70).

SourceLink

On This Page

AlloMax™ (Application CPT/HCPCS: 15777; Product HCPCS: Q4100, C1781)

Cortiva® (Application CPT/HCPCS: 15777; Product HCPCS: Q4100, C9399)

DermACELL™ (Application CPT/HCPCS: 15777; Product HCPCS: Q4122)

FlexHD® Acellular Hydrated Dermis (Application CPT/HCPCS: 15777; Product HCPCS: Q4128)

GalaFLEX® Scaffold / GalaFLEX 3D / 3DR (Application CPT/HCPCS: 15777; Product HCPCS: Q4100, C9399)

Burn wounds

Burn wound product-specific medical necessity (use and application codes noted where applicable):

Biobrane (Application CPT/HCPCS: 15271-15278, C5271, C5273; Product HCPCS: Q4100, C9399) — Considered medically necessary when used for temporary covering of a partial-thickness freshly debrided or excised burn wound.

Biobrane-L (Application CPT/HCPCS: 15271-15278, C5271, C5273, C5275; Product HCPCS: Q4100, C9399) — Considered medically necessary when BOTH: temporary covering of a partial-thickness freshly debrided or excised burn wound; and adjunct to meshed autograft.

Epicel (Application CPT/HCPCS: 15150-15157, C5271, C5273, C5275; Product HCPCS: Q4100, C9399) — Considered medically necessary when used according to the FDA‑approved Humanitarian Device Exemption (HDE) for individuals with deep dermal or full-thickness burns comprising total body surface area ≥ 30%.

Integra® Dermal Regeneration Template / Integra™ Bilayer Matrix Wound Dressing / Integra™ Matrix Wound Dressing / Integra™ Meshed Bilayer Wound Matrix (Application CPT/HCPCS: 15271-15278; Product HCPCS: Q4105, Q4104, Q4108) — Considered medically necessary when BOTH: postexcisional treatment of a full-thickness or deep partial-thickness burn; and sufficient autograft is not available at time of excision or is contraindicated.

Suprathel® (Application CPT/HCPCS: 15271-15278; Product HCPCS: A2012) — Considered medically necessary when used for the treatment of first- and second-degree burns.

Transcyte® (Application CPT/HCPCS: 15271-15278; Product HCPCS: Q4182) — Considered medically necessary when used for temporary covering of a surgically excised deep partial- or full-thickness burn wound as a covering prior to autografting.

Diabetic foot ulcers - product-specific medical necessity

Diabetic foot ulcer product-specific medical necessity. Top-level required criteria (ALL):

When the above medical necessity criteria are met, the following conditions of coverage apply: initial treatment is limited to five applications; additional applications up to a maximum of eight in 12 weeks are considered medically necessary when there is evidence of wound healing (e.g., signs of epithelialization and reduction in ulcer size). Additional applications beyond 12 weeks are considered not medically necessary.

Product-specific examples and coding: ActiGraft® (Application CPT/HCPCS: 15271-15278, C5271, C5273; Product HCPCS: Q4100) — follow the top-level criteria and the applications/limit described above.

AlloPatch Pliable® (Application CPT/HCPCS: 15275-15278) — follow the top-level criteria and the applications/limit described above.

Venous stasis ulcers - product-specific medical necessity

Venous stasis ulcer product-specific medical necessity. Top-level required criteria (ALL):

Product-specific limits and application examples: when top-level criteria are met, initial treatment is limited as specified by product labeling or as otherwise listed in this policy (e.g., limits similar to diabetic foot ulcer application counts where noted). Specific covered products and codes should follow the product sections in this document.

Dural repair

Dural repair: use of tissue-engineered grafts is considered medically necessary when used in association with a covered skull or spinal procedure requiring dural repair.

Medically necessary when used with a covered, medically necessary skull or spine procedure and when the selected graft is appropriate for the dural defect per surgical judgment and product labeling.

Paraesophageal/hiatal hernia repair (mesh)

Paraesophageal/hiatal hernia repair (mesh): Certain absorbable synthetic meshes are considered medically necessary when ANY of the listed product-and-clinical criteria are met.

ANY of the following

Phasix ST (product-specific): used for reinforcement during hiatal/paraesophageal hernia repair when clinical triggers are present (see below).
GORE BIO-A (product-specific): used for reinforcement during hiatal/paraesophageal hernia repair when clinical triggers are present (see below).

Clinical triggers (one or more of the following): disrupted crural fibers; large defect where primary approximation would be under tension; tenuous or otherwise under-tension closure requiring reinforcement.

Parotidectomy

Parotidectomy — AlloDerm criteria:

Considered medically necessary when AlloDerm® is used to reconstruct the parotid bed in association with a covered, medically necessary parotidectomy procedure to restore contour or facilitate soft tissue reconstruction, per surgeon judgment and product labeling.

Not medically necessary / Not covered

Not medically necessary / Not covered: the following product-level determinations and general rule apply.

Products or indications specifically listed elsewhere in this policy as "not medically necessary" or "not covered" (see product-specific sections).

Use of tissue-engineered skin substitutes or related graft products for unlisted indications is considered not medically necessary / not covered due to insufficient evidence unless otherwise specified in this policy.

Experimental, investigational, or unproven products (selected examples)

Experimental, investigational, or unproven products (selected examples). The following are considered investigational/experimental for the indicated uses due to insufficient or inconclusive evidence:

Products identified in product-specific sections as lacking sufficient evidence despite FDA PMA/510(k) status — see product summaries for details and operational coding.

Products with limited or no randomized controlled trial evidence supporting clinical benefit for the requested indication; specific examples and notes are listed in the product evidence summaries.

Notes: examples listed in product leaf nodes (see respective product sections) describe the nature of the evidence gap (e.g., small case series, single-arm studies, surrogate endpoint outcomes only). These products are considered investigational/experimental for those indications and not eligible for coverage.

Professional guideline and consensus positions and Medicare coverage references are summarized in the evidence and conclusions sections of product summaries; where Medicare has a coverage determination, it is noted in the Medicare coverage references in this policy.

Integra IDRT (PMA)PMA and multicenter RCT (Driver 2015) support use for selected nonhealing DFUs and burn indications; significantly improved closure in trial

EpiCord RCTMulticenter RCT (Tettelbach 2018) ITT 12-week healing 70% vs 48% (p=0.0089); larger effects in adequately debrided wounds

Integra Flowable RCTCampitiello 2017: 6-week healing Integra 86.95% vs control 52.17% (p=0.001)

Conclusions emphasize that the overall evidence base is heterogeneous and often limited: a few products have high‑quality RCT data or PMA‑level indications for specific uses, but most products rely on small trials, case series, or registry data. Across product classes there are common evidence limitations—small sample sizes, short follow‑up, heterogeneous wounds and techniques, and lack of head‑to‑head trials—so additional adequately powered randomized controlled trials are needed to establish comparative and long‑term effectiveness for many indications.

Health equity considerations note higher diabetes prevalence in certain racial/ethnic groups and in nonmetropolitan areas; literature lacks data on disparities in access to or use of skin substitute grafts for diabetic foot and venous stasis ulcers. Reviewers should be aware of social determinants of health and gaps in published data on equity when considering access and outcomes for advanced skin substitutes.

Billing Rule

Use appropriate CPT/HCPCS/product codes

When billing for tissue-engineered skin substitutes and related products, use the appropriate application CPT codes and the product HCPCS/Q- or C- codes listed in the policy. Also report product‑specific application codes when indicated (e.g., implant/application codes for soft tissue reinforcement). Claims submitted without the covered application or product codes in this policy will be denied.

Common application CPT ranges: 15040-15261; 15271-15278; 15150-15157; 15275-15278; 15777; 17999 (see policy code table)
Product HCPCS/Q- and C-codes examples: Q4100, Q4101 (Apligraf), Q4105 (Integra DRT), Q4186 (EpiFix), Q4132/Q4133 (Grafix), Q4122 (DermACELL), C1763/C1781 (selected graft/mesh C-codes), C5271/C5273/C5275 (application modifiers)
Product-specific HCPCS list includes many Q-codes (e.g., Q4401 Absolv3, Q4411 AmnioMatrixF4X, Q4345 Matrix HD, Q4413 CYGNUS Solo) — use the exact product code listed

Prior Authorization

Coverage depends on benefit plan and utilization review

Prior authorization and plan‑specific utilization review commonly apply to advanced biologic skin substitutes. Coverage determinations depend on the member's benefit plan and utilization review processes; some Cigna entities only provide utilization review and do not make coverage determinations. Follow payer-specific prior authorization processes and plan terms when requesting coverage.

Prior authorization likely required for advanced/expensive skin substitutes — submit documentation showing SWT failure and product‑specific eligibility
Coverage governed by the member's benefit plan document; plan terms supersede policy where conflicts exist
Utilization review practices and whether determinations are made vary by Cigna company/line of business

Denial Risk

Application limits and time-window enforcement

Denials commonly occur when application limits, time windows, or evidence requirements are not met. The policy enforces product-specific limits on initial and additional applications within defined 12‑week windows and disallows applications beyond specified timeframes. Products lacking sufficient peer‑reviewed evidence are at high risk for noncoverage or be considered investigational.

Application limits and time‑window enforcement — examples include initial application limits of 4 or 5 and maximum additional applications within 12 weeks per product; applications beyond the allowed window will be denied
Products listed as investigational/experimental (policy EIU lists several product Q-codes) are at risk for noncoverage
High denial risk if clinical documentation does not demonstrate product-specific inclusion criteria, evidence of healing for additional applications, or sufficient peer‑reviewed support

Documentation Required

Document product-specific clinical criteria and wound/debridement details

Document product‑specific clinical criteria and procedural details to support medical necessity. Include wound measurements and debridement status, product identifiers, and citation of supporting evidence where available.

Wound type, duration and size — record ulcer type (DFU, VLU), duration, and surface area (many trials specify ranges, e.g., 1–25 cm2)
Perfusion and circulation metrics — ABI, toe pressures, tcpO2 or skin perfusion pressure as applicable (policy threshold ABI ≥ 0.70; tcpO2 ≥ 30 mmHg noted in trials)
Debridement status — document adequate surgical/sharp debridement prior to product application
Product name, manufacturer, HCPCS/Q- or C-code and graft size — include the exact product and size billed
Evidence citation expectations — reference applicable randomized trials or FDA-labeled indications (e.g., Apligraf, Dermagraft, Integra, Grafix, Kerecis) when relying on published support

Cellular and/or Tissue Based Product (skin substitutes and biologic grafts used for wound treatment)

vCHPMviable cryopreserved human placental matrix (GrafixCore)

FSGfish skin graft (Kerecis Omega3 products)

PMA / 510(k)PMA = premarket approval (higher risk); 510(k) = clearance based on substantial equivalence

EpiCord per‑protocol / adequately debrided subgroupPer-protocol and adequately debrided subgroups had larger treatment effect sizes vs control

Differentiated Phasix and Phasix ST in coverage statement and in background

addedLatest

Added policy statement to cover Marigen™ Pacto for diabetic foot ulcers

addedLatest

Added policy statement to cover GRAFIX DUO for diabetic foot ulcers and venous stasis ulcers

addedLatest

Added definition of large hiatal hernia to coverage statement for clarification

addedLatest

Added Allomend and VNEW to EIU policy statement

clarifiedLatest

Clarified Phasix ST mesh is the appropriate type of Phasix mesh for use in paraesophageal/hiatal hernia repair

addedLatest

Added policy statement to cover Galaflex for breast reconstruction

addedLatest

Added policy statement to cover Actigraft and Kerecis for diabetic foot ulcers

addedLatest

Added policy statements to cover multiple products for dural repair

addedLatest

Added policy statement to cover Phasix ST mesh and Gore Bio A for paraesophageal/hiatal hernia repair

addedLatest

Added policy statement to cover Alloderm for use in parotidectomy

removedLatest

Removed Symbotex from the policy

addedLatest

Added multiple new CPT codes for products that are EIU

removedLatest

Removed policy statements for numerous products (unspecified)

addedLatest

Added policy statement of noncoverage for XWrap

addedLatest

Added policy statement of noncoverage for Membrane Wrap and Membrane Graft

addedLatest

Added new CPT code for Matrix HD (listed as EIU)

revisedLatest

Revised policy statement to increase the number of initial applications allowed for venous stasis ulcers

revisedLatest

Revised policy statement to increase the number of initial applications allowed for diabetic foot ulcers

revisedLatest

Revised noncoverage policy statement (unspecified details)