OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

Currentblue cross blue shield - michiganPolicy N/A

Skin and tissue substitutes (bioengineered skin and amniotic products)

Customize your policy alerts

Sign up for all blue cross blue shield - michigan policy alerts

Know when blue cross blue shield - michigan releases new policies or updates existing guidance.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

Medical policy governing coverage and medical necessity criteria for skin and tissue substitute products (including bioengineered skin, human skin equivalents, amniotic/placental-derived products) used for wound care and certain reconstructive and ophthalmologic indications for BCBSM/BCN Medicare Advantage members.

Policy Summary

Payerblue cross blue shield - michigan

PolicySkin and tissue substitutes (bioengineered skin and amniotic products)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJun 20, 2026

Last ReviewJun 1, 2026

Next Review DateN/A

Key ActionDocument a trial and failure of standard of care (minimum 4 weeks with <50% ulcer area reduction) before requesting skin substitute coverage for diabetic or venous ulcers.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

multipledistinct medically necessary indication groups listed

>=1 cm2minimum wound size threshold

4max applications per 12-week episode

65778/65779ophthalmic CPT codes required

>200codes/products listed non-covered/investigational

Coverage Criteria and Determinations

Postmastectomy Breast Reconstruction

Covered when ANY one of the following is met:

Breast reconstruction criteria: Insufficient tissue expander or implant coverage by the pectoralis major muscle requiring additional coverage.

Breast reconstruction criteria: Viable but compromised or thin postmastectomy skin flaps that are at risk of dehiscence or necrosis.

Breast reconstruction criteria: Undermined inframammary and lateral mammary folds during mastectomy requiring reestablishment of these landmarks.

Coverage products note: Specific listed products (e.g., ALLODERM®, ALLOMEND®, CORTIVA®, DERMACELL®, DERMAMATRIX™, FLEXHD®) are considered medically necessary when one of the above criteria is met; all other skin or soft tissue substitute products for postmastectomy breast reconstruction are considered experimental/investigational and not medically necessary.

Policy Summary

Payerblue cross blue shield - michigan

PolicySkin and tissue substitutes (bioengineered skin and amniotic products)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJun 20, 2026

Last ReviewJun 1, 2026

Next Review DateN/A

Key ActionDocument a trial and failure of standard of care (minimum 4 weeks with <50% ulcer area reduction) before requesting skin substitute coverage for diabetic or venous ulcers.

SourceLink

On This Page

Diabetic Foot Ulcers (DFU)

Covered when ALL of the following are met:

DFU medical necessity: Physician documentation of medical management for clinically documented type 1 or type 2 diabetes.

DFU medical necessity: Failure to achieve ≥50% ulcer area reduction after a minimum of 4 weeks of documented compliance with standard of care (SOC) treatment (including offloading, infection control, debridement, moisture balance, nutrition, and optimization of systemic disease).<50% reduction after minimum 4 weeks SOC

DFU medical necessity: Wound is a non-infected full-thickness neuropathic diabetic foot ulcer of at least 1.0 cm² in size due to clinically documented diabetic neuropathy; ulcer extends through the dermis but does not involve tendon, muscle, capsule, or expose bone.>=1.0 cm2

DFU medical necessity: There is adequate arterial blood supply to support tissue growth (e.g., palpable pedal pulses or ABI > 0.70) and the foot is free of Charcot arthropathy.

Product availability note: The following listed products may be considered medically necessary when the above criteria are met: AFFINITY, ALLOPATCH HD®, AMNIOBAND® MEMBRANE OR GUARDIAN, APLIGRAF®, DERMACELL®, DERMA-GIDE®, EPICORD®, EPIFIX®, GRAFIX PRIME/STRAVIX, GRAFTJACKET®, INTEGRA® DRT/OMNIGRAFT™, KERECIS® OMEGA3 (including MARIGEN), NUSHIELD®, OASIS® WOUND MATRIX, PRIMATRIX®, THERASKIN®.

Chronic Venous Insufficiency Lower Extremity Ulcer (VLU)

Covered when ALL of the following are met:

VLU medical necessity: Physician documentation of medical management for clinically documented chronic lower-extremity venous insufficiency.

VLU medical necessity: Failure to achieve ≥50% ulcer area reduction after a minimum of 4 weeks of documented compliance with standard of care (SOC) treatment including compression therapy, debridement, infection control, limb elevation, and optimization of systemic disease.<50% reduction after minimum 4 weeks SOC

VLU medical necessity: Wound is a non-infected full-thickness venous stasis ulcer of at least 1.0 cm² in size; ulcer extends through the dermis but does not involve tendon, muscle, capsule, or expose bone.>=1.0 cm2

VLU medical necessity: There is adequate arterial blood supply to support tissue growth (e.g., palpable pedal pulses or ABI > 0.70).

Product availability note: The following listed products may be considered medically necessary when the above criteria are met: AMNIOBAND® MEMBRANE OR GUARDIAN, APLIGRAF®, EPIFIX®, OASIS® WOUND MATRIX.

Dystrophic Epidermolysis Bullosa (mitten-hand deformity)

Covered when ALL of the following are met:

DEB medical necessity: Use follows the Humanitarian Device Exemption (HDE) specifications for the device (OrCel™) and is limited to mitten-hand reconstruction in dystrophic epidermolysis bullosa.

DEB medical necessity: Standard wound therapy has failed prior to use of the HDE device in this indication.

Evidence note: OrCel™ (HDE) may be considered medically necessary for this specific surgical indication; other skin substitute products for EB are considered experimental/investigational and not medically necessary.

Second- or Third-Degree Burns

Covered when ALL of the following are met:

Burns medical necessity: Wound is thoroughly debrided to remove necrotic tissue, bacteria, and other debris prior to application.

Burns medical necessity: Wound is hemostatic with minimal bleeding to ensure optimal graft take.

Burns medical necessity: Wound is free of infection or infection is controlled as evidenced by negative cultures or significant reduction in bacterial load; healthy granulation tissue is present.

Product availability note: The following products may be considered medically necessary when the above criteria are met: EPICEL® (per HDE for extensive full-thickness burns ≥30% TBSA), INTEGRA® Dermal Regeneration Template (DRT), and TRANSCYTE®.

Ophthalmologic Conditions (amniotic membrane grafts)

Covered when ANY of the listed ophthalmic clinical indications are met and when the applicable CPT codes (65778 or 65779) are used:

Ophthalmic indications: Neurotrophic keratitis with ocular surface damage or inflammation unresponsive to conservative therapy (lubricants, antibiotics/antifungals/antivirals, therapeutic contact lenses, patching).

Ophthalmic indications: Corneal ulcers and melts that do not respond to initial conservative medical therapy.

Ophthalmic indications: Corneal perforation when active inflammation exists after corneal transplant and adjunctive treatment is required; or corneal perforation when donor tissue is not immediately available (temporary coverage).

Ophthalmic indications: Bullous keratopathy as a palliative measure in patients who are not candidates for curative treatment.

Ophthalmic indications: Partial limbal stem cell deficiency with extensive diseased tissue where selective removal alone is insufficient.

Ophthalmic indications: Moderate or severe Stevens-Johnson syndrome with ocular involvement.

Ophthalmic indications: Persistent epithelial defects that do not respond within 2 days to conservative therapy.

Ophthalmic indications: Severe dry eye (DEWS 3 or 4) with ocular surface damage and inflammation symptomatic despite Steps 1–3 of dry eye management algorithms.DEWS 3-4

Ophthalmic indications: Moderate or severe acute ocular chemical burns in select patients.

CPT code requirement: The above medical necessity criteria MUST be met for CPT codes 65778 (placement of amniotic membrane without sutures) or 65779 (placement single layer, sutured) to be covered.

Investigational / Not Reasonable and Necessary Criteria

Not medically necessary / investigational determinations and limits

Investigational Statement: All other skin or soft tissue substitute products and all other uses not specifically listed as medically necessary in this policy are considered investigational, unproven, and not medically necessary due to insufficient peer-reviewed evidence.

Indication-specific requirement: For diabetic foot ulcers or venous lower-extremity ulcers, at least 1 month of standard ulcer therapy must be completed prior to use of skin and tissue substitutes.>=1 month

Application frequency limit: No more than four applications of a skin substitute graft or cellular tissue product (CTP) are allowed within a 12-week episode; combined total across providers applies.<=4 per 12 weeks

Episode duration and exception: Application of a skin substitute graft or CTP beyond 12 weeks per episode is not reasonable and necessary; in exceptional cases additional duration may be considered with documentation and Plan Medical Director review but total applications will not exceed 8.<=12 weeks standard; max 8 applications with exception

Contraindications / not appropriate conditions: Do not place skin substitute graft/CTP on infected, ischemic, or necrotic wound beds; not appropriate for wounds with exposed bone, tendon, or fascia; not for patients with HbA1c >12% or active Charcot arthropathy of the ulcer extremity (except specified DFU exceptions).HbA1c >12%

Non-covered / Investigational products

Products listed in the non-covered sections are considered experimental/investigational and not reasonable and necessary.

Non-covered product condition: Use of any skin substitute product listed by Q-code, HCPCS, or internal code in the policy’s non-covered/investigational product lists is considered experimental/investigational and not reasonable and necessary for all indications.

Illustrative list note: The listed non-covered products are illustrative, not exhaustive; absence of a product from the list does not imply coverage—any product not expressly approved in this policy remains investigational until robust clinical data support inclusion.

Criteria for consideration of skin substitutes

Advanced therapy with skin substitutes may be considered when ALL of the following are met:

Eligibility for skin substitute use: Wound has failed to improve after 4–6 weeks of documented standard of care (SOC) therapy; wound is free of infection, necrotic tissue, sinus tracts/tunnels, and has no exposure of joints/tendons/ligaments/bone; adequate blood supply is demonstrated (palpable pedal pulse or ABI > 0.70); hemoglobin A1c is controlled (<12%) and systemic factors have been optimized.

Documentation requirement: Documentation must include description of wound size and depth, SOC therapies provided and compliance, measured ulcer area and percent reduction during SOC, evidence of adequate perfusion, and absence of exclusionary diagnoses (e.g., active infection, osteomyelitis).

Diabetic Foot Ulcer coverage conditions

Coverage may be supported when product-specific evidence demonstrates meaningful improvement and when patient selection criteria are met

Diabetic Foot Ulcers - evidence contingent coverage: Product is one of the listed skin substitute/CTP products evaluated in randomized controlled trials showing faster healing versus standard of care and the patient meets trial-like inclusion criteria (e.g., chronic DFU size, duration, and SOC applied).

Documentation and trial-like criteria: Document that the patient selection and wound characteristics align with those used in positive RCTs for the specific product to support coverage.

Venous ulcer coverage conditions

Covered when ALL of the following are met:

Venous Stasis Lower-Extremity Ulcers: Product is one of the listed products with RCT evidence for venous leg ulcers (e.g., AmnioBand® Membrane/Guardian, Apligraf®, EpiFix®, Oasis®) AND the patient meets inclusion criteria similar to those studied (documented SOC including compression and failure to achieve ≥50% area reduction after minimum 4 weeks).

Documentation requirement: Document SOC therapies, percent area reduction during SOC, wound size (≥1.0 cm²), absence of infection, and adequate arterial perfusion before applying product-specific evidence to support coverage.

Breast reconstruction

Covered when ALL of the following are met:

ADM use in breast reconstruction: ADM may be used to provide additional support or tissue coverage when clinically indicated (insufficient tissue coverage, compromised soft tissue, or need to reestablish anatomic landmarks); informed/shared decision-making is recommended given variable safety profiles and FDA communications regarding complication risks.

Product and evidence note: Specific listed ADMs (e.g., AlloDerm®, AlloMend®, Cortiva®, DermACELL®, DermaMatrix™, FlexHD®) have RCTs and systematic reviews to inform use; inclusion in the policy indicates considered medically necessary when clinical criteria are met.

Deep dermal burns

Covered when ALL of the following are met:

Extensive full-thickness burns: Use of Epicel® (HDE) and other approved dermal substitutes is limited to patients matching the product indications (e.g., Epicel® for extensive full-thickness burns with insufficient donor skin); wounds must be prepared and patient selection must align with device labeling and HDE/PMA conditions.

Evidence and limitations: Integra DRT, TransCyte, and Epicel have RCTs or substantial series supporting use in second- and third-degree burns; Recell® has limited and heterogeneous RCT data and is considered insufficient to establish net health benefit for some deep dermal burn indications.

Indication-specific coverage determinations

Indication-specific determinations and supporting evidence summary

Dystrophic Epidermolysis Bullosa summary: OrCel™ has an HDE for hand reconstruction in recessive dystrophic EB; evidence is limited and insufficient to determine net health outcome improvements for broader EB indications.

Deep dermal burns summary: Epicel®, Integra DRT, and TransCyte have evidence supporting use in second- and third-degree burns when criteria are met, with known infection/complication risks (e.g., Integra overall take rates ~86-95% and infection rates noted). Recell® evidence is mixed and insufficient to conclude net health benefit for some deep burn uses.

Ophthalmic indications summary: Specific HAM indications (neurotrophic keratitis, corneal ulcers/melts, corneal perforation, bullous keratopathy palliative use, partial LSCD, Stevens-Johnson syndrome, persistent epithelial defects, severe dry eye DEWS 2-4, acute chemical burns, pterygium repair when autograft unavailable) may be considered medically necessary when defined criteria are met; evidence sufficiency varies by indication.

Musculoskeletal indication note: Amniotic/placental-derived products for musculoskeletal indications are considered investigational for non-wound uses and should follow MAC LCD guidance.

Hernia repair — insufficient evidence

Evidence summary and coverage stance

Hernia/parastomal reinforcement: Acellular collagen-based scaffolds and bioengineered soft tissue substitutes have not demonstrated clear benefit over synthetic mesh in RCTs; evidence is insufficient to establish improved net health outcome and use for hernia repair or parastomal reinforcement is considered investigational/not medically necessary.

Mohs surgery reconstruction with dHACM: Use of dehydrated human amnion/chorion membrane (dHACM, e.g., EpiFix) after Mohs surgery is supported only by retrospective observational data with limitations; evidence is insufficient to conclusively demonstrate improved overall health outcomes.

Adjunctive use after failure of SOC

Covered as adjunctive therapy when specified standard-of-care criteria are met

Adjunctive CTP use for DFU/VLU: CTPs/CAMPs may be considered as adjunctive therapy for DFU or VLU when wounds fail to demonstrate improvement after a guideline-recommended SOC trial (commonly defined as failure to achieve >50% area reduction after a minimum of 4 weeks) and contributing factors are optimized.>50% area reduction in 4 weeks

Guideline alignment: Decision to use adjunctive CTPs should align with society guidelines (SVS/APMA/SVM, IWGDF) and documented trial-like inclusion criteria from positive studies.

Covered Indications with Exclusion

Covered when ALL of the following are met

Primary covered diagnosis: Member has an ICD-10 diagnosis code within the listed covered ranges that support medical necessity for the requested skin or tissue substitute (e.g., second- or third-degree burns T20–T25/T31; ocular diagnoses H04–H18; ulcer codes L97/L89; breast malignancy C50 and related history codes).

No exclusionary diagnosis present: None of the 'Codes that Do Not Support Medical Necessity' (for example active infection, gangrene, osteomyelitis, necrotizing fasciitis, disorders of zinc metabolism) are present on the claim or in the clinical documentation.

Non-Covered / Investigational Products

Not covered when ANY of the following apply

Product not listed as approved: Use of any bioengineered skin and soft tissue substitute product that is not explicitly listed as covered in this policy is considered investigational and not medically necessary.

Listed as investigational: Products, HCPCS/CPT/Q-codes, or other codes listed in the 'Non-Covered / Investigational Products' sections are not covered for any indication.

Unlisted code handling: Unlisted codes submitted for services addressed in this policy will be reviewed at the claim level and may be denied as not covered; inclusion or omission of a code in the policy does not guarantee reimbursement.

Codes, Code Status, and Coding Guidance

Covered CPT Codes (ophthalmic amniotic membrane)CPTCovered

65778	Placement of amniotic membrane on the ocular surface; without sutures
65779	Placement of amniotic membrane on the ocular surface; single layer, sutured

Diagnosis codes that do not support medical necessityICD-10Not Covered

A49.01 - A49.8	Bacterial infection of unspecified site
B78.1	Cutaneous strongyloidiasis
B95.0 - B95.8, B96.0 - B96.89	Streptococcus, staphylococcus, enterococcus, and other bacterial agents as the cause of diseases classified elsewhere
E83.2	Disorders of zinc metabolism
I96	Gangrene
L08.82 - L08.9	Other and unspecified local infections of skin and subcutaneous tissue
M72.6	Necrotizing fasciitis
M86.00 - M86.9	Osteomyelitis
M87.00 - M87.9	Osteonecrosis

Non-covered / investigational HCPCS/C codes and named products (partial list)HCPCSNot Covered

A2001	INNOVAMATRIX AC, PER SQ CM
A2002	MIRRAGEN ADVANCED WOUND MATRIX, PER SQ CM
A2004	XCELLISTEM, 1 MG
A2005	MICROLYTE MATRIX, PER SQ CM
A2006	NOVOSORB SYNPATH DERMAL MATRIX, PER SQ CM
A2007	RESTRATA, PER SQ CM
A2008	THERAGENESIS, PER SQ CM
A2009	SYMPHONY, PER SQ CM
A2010	APIS WOUND MANAGEMENT DEVICE, PER SQ CM
A2011	SUPRA SDRM, PER SQ CM

1–10 of 53

1/6

Non-covered / Investigational Q-codes and productsHCPCSNot Covered

Q4226	DERMABIND TL, PER SQ CM
Q4227	MYOWN SKIN, INCLUDES HARVESTING AND PREPARATION PROCEDURES, PER SQ CM
Q4229	AMNIOCORE, PER SQ CM
Q4230	COGENEX AMNIOTIC MEMBRANE, PER SQ CM
Q4231	COGENEX FLOWABLE AMNION, PER 0.5 CC
Q4232	CORPLEX P, PER CC
Q4233	CORPLEX, PER SQ CM
Q4234	SURFACTOR OR NUDYN, PER 0.5 CC
Q4235	XCELLERATE, PER SQ CM
Q4236	AMNIOREPAIR OR ALTIPLY, PER SQ CM

1–10 of 202

1/21

PMA / Class III device examplesmixed

PMA examples

Apligraf®; Epicel®; OrCel™; Recell® (examples of PMA-classified or HDE devices described)

BLA-coded products referencedmixed

J3401	Vyjuvek (topical gene therapy) BLA code listed in document
J3389	Zevaskyn (autologous gene-corrected epidermal cell-sheet therapy) BLA code listed in document

Non-covered / insufficient evidence HCPCS-coded productsHCPCSNot Covered

Q4355	ABIOMEND MEMBRAND
Q4356	ABIOMEND HYDROMEMBRAND

Covered HCPCS/CPT CodesmixedCovered

A2019	KERECIS OMEGA3 MARIGEN SHIELD (Diabetic Foot Ulcer) 510(k)
C1762	ALLOMEND (Breast Reconstruction) 361 HCT/P
Q4101	APLIGRAF® (Diabetic Foot Ulcer, Venous Leg Ulcer) PMA
Q4102	OASIS® WOUND MATRIX (Diabetic Foot Ulcer, Venous Leg Ulcer) 510(k)
Q4104	INTEGRA BILAYER MATRIX WOUND DRESSING (2nd or 3rd Degree Burns) 510(k)
Q4105	INTEGRA® DRT/OMNIGRAFT DRM (Diabetic Foot Ulcer, 2nd or 3rd Degree Burns) PMA
Q4107	GRAFTJACKET® (Diabetic Foot Ulcer) 361 HCT/P
Q4110	PRIMATRIX® (Diabetic Foot Ulcer, Venous Leg Ulcer) 510(k)
Q4116	ALLODERM (Breast Reconstruction) 361 HCT/P
Q4121	THERASKIN® (Diabetic Foot Ulcer) 361 HCT/P

1–10 of 44

1/5

ICD-10 Codes that support medical necessityICD-10Covered

C50.011-C50.919	Malignant neoplasm of breast code range (female codes only listed)
Z85.3	Personal history of malignant neoplasm of breast
E08.00-E13.9	Diabetes mellitus range (dual diagnosis requirement noted for specific ulcer codes)
L97.111-L97.822	Ulcer codes (various site/severity codes referenced as required when reporting certain comorbid codes)
L89.5-L89.626	Pressure ulcer codes
I83.011-I83.228	Varicose veins codes (with requirement to report L97.xxx to identify ulcer site/severity)
I87.xxx	Post thrombotic syndrome / related codes (require accompanying L97 codes)
Q81.2	Dystrophic Epidermolysis Bullosa
T20.20XA-T25.799S	Burns/corrosions second or third degree by site
T31.0-T32.99	Burns/corrosions classified by extent of body surface

1–10 of 14

1/2

Covered ICD-10 Codes (support medical necessity)ICD-10Covered

T20.20XA-T20.39XS	Burn of second or third degree of head, face, and neck
T20.60XA-T20.79XS	Corrosion of second or third degree of head, face, and neck
T21.20XA-T21.39XS	Burn of second or third degree of trunk
T21.60XA-T21.79XS	Corrosion of second or third degree of trunk
T22.20XA-T22.399S	Burn of second or third degree of shoulder and upper limb, except wrist and hand
T22.60XA-T22.799S	Corrosion of second or third degree of shoulder and upper limb, except wrist and hand
T23.201A-T23.399S	Burn of second or third degree of wrist and hand
T23.601A-T23.799S	Corrosion of second or third degree of wrist and hand
T24.201A-T24.399S	Burn of second or third degree of lower limb, except ankle and foot
T24.601A-T24.799S	Corrosion of second or third degree of lower limb, except ankle and foot

1–10 of 26

1/3

Codes that Do Not Support Medical Necessity (when present)ICD-10Not Covered

A49.01-A49.8	Bacterial infection of unspecified site
B78.1	Cutaneous strongyloidiasis
B95.0-B96.89	Streptococcus, staphylococcus, enterococcus, and other bacterial agents as cause
E83.2	Disorders of zinc metabolism
I96	Gangrene
L08.82-L08.9	Other and unspecified local infections of skin and subcutaneous tissue
M72.6	Necrotizing fasciitis
M86.00-M86.9	Osteomyelitis
M87.00-M87.9	Osteonecrosis

Non-covered / Investigational HCPCS/CPT/Product Codes (illustrative list)mixedNot Covered

A2001	INNOVAMATRIX AC, PER SQ CM (510(k))
A2002	MIRRAGEN ADVANCED WOUND MATRIX, PER SQ CM (510(k))
A2004	XCELLISTEM, 1 MG (510(k))
A2005	MICROLYTE MATRIX, PER SQ CM (510(k))
A2006	NOVOSORB SYNPATH DERMAL MATRIX, PER SQ CM (510(k))
A2007	RESTRATA, PER SQ CM (510(k))
A2008	THERAGENESIS, PER SQ CM (510(k))
A2009	SYMPHONY, PER SQ CM (510(k))
A2010	APIS WOUND MANAGEMENT DEVICE, PER SQ CM (510(k))
A2012	SUPRATHEL, PER SQ CM (510(k))

1–10 of 34

1/4

Non-covered / Investigational Q-codesHCPCSNot Covered

Q4209	SURGRAFT, PER SQ CM
Q4211	AMNION BIO OR AXOBIOMEMBRANE, PER SQ CM
Q4212	ALLOGEN, PER CC
Q4213	ASCENT, 0.5 MG
Q4214	CELLESTA CORD, PER SQ CM
Q4215	AXOLOTL AMBIENT OR AXOLOTL CRYO, 0.1 MG
Q4216	ARTACENT CORD, PER SQ CM
Q4217	WOUNDFIX, BIOWOUND, WOUNDFIX PLUS, BIOWOUND PLUS, WOUNDFIX XPLUS OR BIOWOUND XPLUS, PER SQ CM
Q4218	SURGICORD, PER SQ CM
Q4219	SURGIGRAFT-DUAL, PER SQ CM

1–10 of 79

1/8

Codes considered experimental/investigational when reported with RECELL TherapyCPT | HCPCSNot Covered

15011	Harvest of skin for skin cell suspension autograft; first 25 sq cm or less
15012	Harvest of skin for skin cell suspension autograft; each additional 25 sq cm or part thereof
15013	Preparation of skin cell suspension autograft, manual enzymatic processing; first 25 sq cm or less
15014	Preparation of skin cell suspension autograft, manual enzymatic processing; each additional 25 sq cm
15015	Application of skin cell suspension autograft to wound and donor sites; first 480 sq cm or less
15016	Application of skin cell suspension autograft; each additional 480 sq cm or part thereof
15017	Application of skin cell suspension autograft to face/scalp/etc; first 480 sq cm or less
15018	Application of skin cell suspension autograft to face/scalp/etc; each additional 480 sq cm or part thereof
C8002	Preparation of skin cell suspension autograft, automated, including all enzymatic processing and device components

No codes listedmixed

No codes listed

Codes with status changes noted in policy historymixed

Q4116	listed in policy history (moved between indications)
Q4182	listed in policy history (moved between indications)
Q4201	status updated per policy history
A2019	status updated per policy history
Q4158	status updated per policy history
Q4160	status updated per policy history
Q4106	listed in policy history (removed in later update)
Q4186	status updated per policy history
Q2124	status updated per policy history
Q4110	status updated per policy history

1–10 of 39

1/4

inv-71: Minimum wound size — >= 1.0 cm2

Minimum wound area>= 1.0 cm2

Applies toNon‑infected, full‑thickness diabetic foot ulcers or venous stasis ulcers

Measured howDocumented wound surface area (cm2) in clinical chart prior to application

inv-72: Required ulcer area reduction failure after SOC — < 50% reduction after minimum 4 weeks of documented SOC

Failure threshold after SOC< 50% ulcer area reduction after a minimum 4 weeks of documented standard of care (SOC)

SOC elements requiredIncludes debridement, offloading/compression, infection control, moisture balance, vascular assessment and optimization

DocumentationProgress notes showing wound measurements and SOC compliance over the 4‑week period

inv-73: HbA1c — > 12%

Hemoglobin A1c threshold making use not reasonable> 12% (uncontrolled — not reasonable and necessary)

Recommended target for considerationAchieve routine medical management and A1c < 12% to maximize healing potential

DocumentationRecent laboratory A1c value in medical record prior to application

inv-74: Minimum standard ulcer therapy duration — >= 1 month

Minimum duration of standard ulcer therapy>= 1 month (at least 4 weeks) prior to skin substitute use for DFU/VLU

Alternate guideline rangeGuidance and evidence often reference 4–6 weeks of SOC prior to advanced therapy

Required documentationClinical notes demonstrating SOC interventions and patient adherence for the minimum period

inv-75: Maximum applications per 12-week episode — <= 4

Maximum applications per 12‑week episode<= 4 total applications (combined across providers) within a 12‑week episode

ExceptionsAdditional applications may be considered only with Medical Director review and documentation

Denial riskMore than four applications in 12 weeks may be denied as not reasonable and necessary

inv-76: Maximum episode duration (standard) — <= 12 weeks (extensions reviewed case-by-case)

Standard maximum episode duration<= 12 weeks per treatment episode; extensions require Plan Medical Director review

Exceptional total application capEven with exception review, total applications generally will not exceed 8

Documentation for extensionProgress notes demonstrating wound closure progress and expected benefit required for review

inv-77: Standard care trial duration — 4-6 weeks

Typical standard care trial duration before CTP4-6 weeks of documented SOC prior to considering skin substitutes

SOC elementsDebridement, infection control, offloading/compression, moisture balance, vascular assessment, nutrition

Evidence/guideline basisReferenced in evidence‑based SOC guidance (AHRQ, SVS, IWGDF) as period to assess response

inv-78: Ankle-brachial index (ABI) — > 0.70

Ankle‑brachial index (ABI) perfusion threshold> 0.70 (ABI > 0.70 acceptable indicating adequate arterial supply)

Alternate clinical signOr palpable pedal pulses may be used to document adequate blood supply

PurposeRequired to support tissue growth and justify skin substitute application

inv-79: Hemoglobin A1c — < 12%

Acceptable Hemoglobin A1c for consideration< 12% (A1c <12% expected for consideration of skin substitute therapy)

Unacceptable value>= 12% contraindicates use until controlled

DocumentationRecent A1c lab result included in record prior to treatment

inv-80: DEWS score for severe dry eye — 2-4

DEWS severity range for HAM in severe dry eye2-4 (DEWS 2–4 referenced for moderate‑to‑severe disease)

Indication contextUsed when severe dry eye is refractory to conservative therapy

DocumentationDEWS score and prior conservative therapy attempts should be recorded

inv-81: wound response threshold — >50% wound area reduction in 4 weeks (used by SVS guideline as threshold to consider adjunctive therapy)

Wound response threshold prompting adjunctive therapy>50% wound area reduction in 4 weeks used as improvement threshold; failure to meet this prompts consideration of adjunctive therapy

Guideline sourceReferenced in SVS/APMA/SVM and other guideline statements for DFU management

Clinical actionIf wound fails to reach >50% reduction at 4 weeks, evaluate for advanced therapies

inv-82: priority endpoint — percentage area reduction in 4-8 weeks

Priority trial endpoint for studies and clinical monitoringPercentage area reduction in 4–8 weeks (priority endpoint)

Other important endpointsTime to heal, percentage volume reduction, function, recurrence, infection, amputation rates

Use in practiceUsed to assess early response to SOC and adjunctive therapies in trials and clinical care

inv-83: Wound surface area coding thresholds — G0681/G0683 and 15271/15273 family: first 25 sq cm or first 100 sq cm thresholds; additional codes for each additional 25 or 100 sq cm

Coding families and initial thresholdsG0681/G0683 and 15271/15273 families: first 25 sq cm (or first 100 sq cm for large‑area codes) apply as the initial billing threshold

Add‑on code structureAdditional codes are used for each additional 25 sq cm or 100 sq cm increment as specified by the code family

Applies toNon‑sheet and sheet form skin substitute graft application reporting

Provider Requirements, Documentation, and Authorization

Billing Rule

Ophthalmic amniotic membrane CPT code requirement

Coverage for human amniotic membrane grafts to the ocular surface is conditional on using CPT code 65778 (placement without sutures) or 65779 (single layer, sutured) and meeting the ophthalmic clinical criteria listed in the policy.

Prior Authorization

Authorization required for exceptions

Prior authorization or Plan Medical Director review is implied for exceptions to the policy limits — e.g., cases exceeding the application limits or extended treatment durations — and such requests must include documentation of wound progress.

Note

Coverage and prior authorization headline

BCBSM/BCN follows CMS guidance and applies internal coverage criteria; products without sufficient peer‑reviewed evidence are considered non‑covered and may require prior authorization or supporting documentation in accordance with Medicare guidance.

Billing Rule

CMS reclassification affects billing/coverage category

Effective January 1, 2026 CMS reclassified most skin and tissue substitute products as 'incident‑to‑supplies' and grouped them by regulatory pathway (PMA, 510(k), or 361 HCT/P); products with a BLA remain excluded from the incident‑to‑supplies category.

Prior Authorization

Prior authorization for HAM ophthalmic indications

Prior authorization for ophthalmic HAM indications should verify that the specific indication meets the policy's defined clinical criteria (for example, refractory disease, severity thresholds such as DEWS 3–4, or lack of alternative viable donor tissue) and that conservative therapies were tried when applicable.

Prior Authorization

Authorization required for off‑standard indications

Prior authorization may be required to justify use of amniotic or placental‑derived products when standard options (e.g., conjunctival autograft for pterygium or synthetic/autologous tissue for surgical repairs) are unavailable or unsuitable, and when evidence is insufficient for the indication.

Prior Authorization

Prior authorization — justify application count

Prior authorization requests should include clinical justification for the number of product applications and objective evidence of wound nonresponse or progression (studies report average application counts around 3.7–4 and diminishing returns after ~7 applications).

Prior Authorization

Medical necessity required for coverage

Coverage of listed skin and tissue substitute products is contingent on meeting the policy's medical necessity criteria; inclusion of a code in the policy does not guarantee coverage or reimbursement without documentation demonstrating medical necessity.

Denial Risk

Unlisted codes reviewed; potential denial

All unlisted codes are reviewed at the claim level for medical necessity, correct coding, and pricing; unlisted services addressed in this policy will be denied as not covered when submitted without supporting justification.

Denial Risk

Investigational Q‑code list (examples)

The policy identifies numerous Q‑codes as investigational and non‑covered for all indications; providers should not expect prior authorization to convert these listed investigational Q‑coded products to covered status absent policy approval.

Note

Prior authorization and claim submission reminder

Providers are required to review applicable BCBSM reimbursement policies prior to claim submission and follow any prior authorization rules in the provider manual; non‑contracted providers may be asked to submit supporting documentation for billed claims.

Note

Prior authorization not specified in this segment

This document segment provides evidence citations for CAMP products but does not specify prior authorization requirements or affected billing codes in this excerpt.

Note

Prior authorization not specified in this excerpt

These excerpted chunks do not list specific prior authorization requirements or affected billing codes.

Documentation Required

Verify authorization and code status

Policy history documents changes to multiple HCPCS/CPT codes and CMS guidance updates; providers should verify whether a prior authorization is required and confirm current code status before claim submission.

Step Therapy

Prior SOC required

For wound indications, providers must document a trial and documented failure of standard of care measures (debridement, offloading/compression, infection control, perfusion assessment, moisture balance, nutrition, and systemic disease management) prior to using skin substitutes.

Step Therapy

Step therapy: try standard care first

For diabetic foot or lower‑extremity venous ulcers, skin and tissue substitutes are considered not medically necessary unless at least 1 month of standard ulcer therapy has been attempted and documented.

Step Therapy

Step therapy / treatment sequencing

Providers must document completion of standard‑of‑care wound measures — wound cleansing/debridement, infection management, correction of ischemia, moisture balance, compression/offloading, management of systemic disease and nutrition — before advanced therapies are considered.

Note

Evidence‑based step considerations

Evidence supporting advanced skin substitutes is product‑ and indication‑specific and often heterogeneous; payers may therefore require that patients meet trial‑like inclusion criteria or demonstrate SOC failure before authorizing advanced therapies.

Step Therapy

Conservative therapy prerequisite

For many ocular indications, HAM is considered only after conservative therapies (lubricants, topical antimicrobials, therapeutic contact lenses, patching, or topical anti‑inflammatories) have failed; documentation of prior conservative therapy is implied.

Prior Authorization

Step authorization for off‑standard uses

When requesting authorization for alternative grafts or novel applications (e.g., pterygium repair, hernia reinforcement), providers should document prior use or unsuitability of standard therapies and justify the clinical rationale for the alternate approach.

Documentation Required

Document extended treatment justification

Clinical and administrative documentation for exceptional treatment beyond standard limits must demonstrate wound closure progress and the expected benefit to the member for Plan Medical Director review.

Documentation Required

Required clinical documentation for DFU/VLU

Physician documentation for DFU/VLU authorization must include underlying diagnosis (diabetes or chronic venous insufficiency), documented compliance with SOC (minimum 4 weeks), objective wound measurements, evidence of adequate perfusion (palpable pedal pulse or ABI > 0.70), and absence of infection or exposed bone/tendon/muscle.

Documentation Required

Required documentation for breast reconstruction

For postmastectomy breast reconstruction, include documentation demonstrating insufficient implant/expander coverage, compromised or thin postmastectomy skin flaps at risk, or need to reestablish undermined mammary fold landmarks to support use of listed ADMs.

Documentation Required

Document application frequency and wound response

Documentation supporting continued applications should include the number and timing of applications and objective wound‑size response data (for example, early area reductions within the first 5 applications) to justify additional treatments.

Billing Rule

Q4431 product name reporting

If reporting a skin substitute product under HCPCS Q4431, the product name must be included in the claim narrative/remarks or the claim will be returned or rejected.

Billing Rule

Claim‑level review and Medicare reminder

Claims are reviewed at the claim level for medical necessity, correct coding, and pricing; presence of a CPT/HCPCS code in the policy does not guarantee payment — verify member benefits and applicable Medicare guidance.

Denial Risk

Evidence requirement for product coverage

Products not expressly identified as approved in the policy remain not reasonable and necessary until robust clinical data support inclusion; providers should expect coverage denial absent such evidence.

Documentation Required

Documentation submission expectation

Providers may be required to submit medical records and other documentation to support billed claims, particularly for non‑contracted providers or when Medicare guidance is evolving.

Billing Rule

Match coding to policy history

Match submitted coding and supporting documentation to the policy history and current code status; interim updates have added and removed numerous HCPCS/CPT codes, so verify that submitted codes align with the latest policy and CMS guidance.

Denial Risk

SOC documentation — denial risk if missing

Failure to document at least 4 weeks of standard of care with objective evidence (e.g., <50% ulcer area reduction) for DFU/VLU indications may trigger claim denial.

Denial Risk

Denial for non‑approved or unlisted products

Claims for any skin or tissue substitute product that is not expressly identified in this policy as an approved product for the specific indication will be considered not reasonable and necessary and may be denied.

Denial Risk

Denial for excess applications or extended duration

More than four applications within a 12‑week episode, or applications beyond 12 weeks without Plan Medical Director review and supporting documentation, risk denial; exceptional cases require Medical Director review and documentation of wound progress.

Note

Background, Definitions, and Scope

Skin substitutes (including bioengineered skin, human skin equivalents, and amniotic/placental‑derived products) are applied to wounds to facilitate healing by mimicking properties of skin and providing a scaffold or biologically active dressing to promote granulation and re‑epithelialization. The policy describes these products as adjuncts to wound care and reconstructive procedures rather than replacements for autologous grafts, and lists human, animal, synthetic, and combination sources and their clinical roles.

inv-147: Amniotic products — definition and scope

DefinitionProducts derived from amnion, chorion, amniotic fluid, and umbilical cord used as grafts or biologic dressings

FormsPrepared as grafts, patches, or injections; may be fresh, cryopreserved, or dehydrated

Clinical usesUsed for wound healing, ocular surface disorders, burns, and explored in musculoskeletal repair

inv-148: Skin substitute — definition

DefinitionBioengineered skin products (skin substitutes) that mimic properties of skin to facilitate healing but do not replace autologous grafts

TypesIncludes acellular dermal matrices and cellular skin substitutes (HCT/Ps) with varying complexity and storage requirements

Primary functionProvide scaffold/matrix, reduce fluid loss, protect wound, and support host cell ingrowth

inv-149: Unsuccessful therapy / previous application failure — definition

Definition of unsuccessful prior therapyIncreased ulcer size/depth, no measurable change, no sign of improvement, or ulcer recurrence at same site within 12 months

ContextUsed to define prior application failure for reapplication restrictions and investigational determinations

Documentation neededWound measurements and clinical notes documenting lack of improvement after prior application

inv-150: Excessive wastage — definition

DefinitionWastage occurring when biologic graft size materially exceeds wound size resulting in excessive discarded product

Policy implicationProducts should be sized to closely fit wound to minimize waste; excessive wastage may trigger review

Example actionDocument rationale if larger graft is used and unavoidable

inv-151: Acellular dermal matrix (ADM) — definition

DefinitionAcellular dermal matrix (ADM): donor dermis processed to remove cells and antigenic material, leaving a scaffold for host cell ingrowth

Clinical roleUsed for soft tissue reinforcement (e.g., breast reconstruction) and wound coverage

Risks/considerationsPotential for infection, variable complication rates; FDA has issued safety communications regarding some ADMs

inv-152: Cellular skin substitutes / HCT/Ps — definition

DefinitionCellular skin substitutes / HCT/Ps: products containing living cells within a matrix that may provide growth factors and cytokines

Regulatory noteMany are regulated as 361 HCT/Ps if minimally manipulated and homologous; others require PMA or BLA

Clinical considerationsMore complex storage, shorter shelf life, potential theoretical infection or immunologic risks

inv-153: Human amniotic membrane (HAM) — definition

DefinitionHuman amniotic membrane (HAM): amnion/chorion-derived tissue (cellular or acellular) containing cells, proteins, and growth factors used as graft/patch/injectable forms

Processing formsCan be cellular or acellular; available cryopreserved, dehydrated, or fresh

Common ophthalmic productsCommercial devices (e.g., Prokera) deliver cryopreserved HAM to ocular surface

inv-154: PMA (Premarket Approval) — definition

DefinitionPMA (Premarket Approval): FDA's most stringent device pathway for Class III devices requiring valid scientific evidence of safety and effectiveness

When usedRequired for high‑risk interactive dressings or devices incorporating living cells

Practical notePMA‑approved products carry higher regulatory scrutiny and evidence expectations

inv-155: 510(k) Premarket Notification — definition

Definition510(k) Premarket Notification: FDA pathway for devices demonstrating substantial equivalence to a legally marketed predicate (commonly used for many acellular wound matrices)

Typical productsMany acellular and synthetic matrices are cleared via 510(k)

Reimbursement noteSome coding (G‑codes/CPT) reference 510(k)/PMA/361 regulatory categories explicitly

inv-156: 361 HCT/P — definition

Definition361 HCT/P: human cells, tissues, and cellular/tissue‑based products that are minimally manipulated and intended for homologous use; regulated under Section 361

Regulatory implication361 products do not require premarket approval if criteria met, but non‑homologous or more‑than‑minimally‑manipulated products shift to 351/BLA or device pathways

ExamplesSeveral amniotic membrane and allograft products are managed under 361 when criteria satisfied

inv-157: BLA (Biologics License Application) — definition

DefinitionBLA (Biologics License Application): regulatory pathway under Section 351 for biologics requiring substantial evidence from clinical trials and cGMP manufacturing

ExamplesTopical gene therapies and autologous gene‑corrected cell‑sheet therapies (e.g., Vyjuvek, Zevaskyn) are BLA‑licensed

Coverage noteBLA products are excluded from CMS 'incident‑to‑supplies' reclassification and handled separately

inv-158: Integra Dermal Regeneration Template (DRT) — definition/example

Example productIntegra Dermal Regeneration Template (DRT): bilayer bovine collagen‑GAG dermal scaffold with silicone epidermal layer

Clinical roleSupports neovascularization and dermal regeneration in burn care; documented take rates and infection risks in studies

Evidence summaryUsed in pediatric and extensive burn populations with substantial supporting literature

inv-159: Epicel / TransCyte — definition/examples

ExamplesEpicel: autologous epidermal sheet cultured from patient's keratinocytes (HDE for extensive full‑thickness burns); TransCyte: synthetic dermal substitute

Indication notesEpicel used when donor skin insufficient; TransCyte shown to accelerate re‑epithelialization in RCTs

Regulatory statusEpicel under HDE; TransCyte has clinical trial support and regulatory clearances depending on product version

inv-160: Prokera / self-retained c-HAM — definition/example

Example product/formProkera/self‑retained cryopreserved human amniotic membrane (c‑HAM) devices deliver HAM to ocular surface

Use caseEmployed for severe dry eye, epithelial defects, and other ocular surface disorders refractory to conservative therapy

EvidenceRandomized and case series data support symptomatic and epithelial improvements in select indications

inv-161: HAM (human amniotic membrane/dHACM) — definition

DefinitionHAM (human amniotic membrane/dHACM): human placental‑derived membranes used as allografts to promote wound healing and reduce inflammation

FormsIncludes dehydrated human amnion/chorion membrane (dHACM) and cryopreserved HAM

Clinical applicationsUsed for chronic lower‑extremity wounds, ophthalmic indications, and select surgical repairs

inv-162: CAMP / CTP — definition

DefinitionCAMP/CTP: Cellular, Acellular and Matrix‑like Products — scaffolds or biologically active dressings used to support wound healing

TerminologyAlso referred to as cellular/tissue products (CTPs) or skin substitute graft/CTP in this policy

Clinical noteUsed as adjunctive therapies when wounds fail to respond to SOC and risk factors optimized

inv-163: Stalled wound — definition

DefinitionStalled wound: chronic wound that has failed to progress towards healing after an appropriate period of evaluation and management (e.g., ~4 weeks)

Clinical implicationConsider adjunctive therapy (e.g., skin substitutes) when wound remains stalled after SOC and optimization of factors

DocumentationSerial wound measurements demonstrating lack of progress define a stalled wound

inv-164: Skin substitute graft (per CPT) — definition

Definition per CPTSkin substitute graft (per CPT): non‑autologous dermal/epidermal cellular or acellular grafts (homograft, allograft, xenograft, bioengineered sheets)

ExclusionsCPT skin substitute graft codes exclude non‑graft wound dressings (gels, liquids) and injectable skin substitutes

Coding implicationUse appropriate application codes (G0681/G0683, 15271/15273 family) for graft application billing

inv-165: Covered indications (ICD-10) — definition / reference

Covered diagnosis rangesICD‑10 ranges for 2nd/3rd degree burns, select ocular diagnoses, diabetic and venous ulcer codes support medical necessity

Use in claimsAppropriate ICD‑10 code from listed ranges must be present and no exclusionary diagnosis codes should be on claim

ExamplesBurn codes T20‑T25 ranges; pterygium H11.x; dry eye H04.12x; corneal ulcer H16.x

inv-166: Non-covered / investigational products — definition

DefinitionNon‑covered / investigational products: listed HCPCS/CPT/Q‑codes and named products deemed experimental due to insufficient peer‑reviewed evidence

Policy effectUse of these products is considered not reasonable and necessary for all indications until robust clinical data support inclusion

List natureIllustrative, not exhaustive — absence from list does not imply coverage

inv-167: Non-covered / Investigational products — definition (insufficient peer-reviewed evidence)

Insufficient evidence definitionProducts for which peer‑reviewed literature does not provide sufficient evidence of clinical effectiveness or positive health impact

Policy actionSuch products are classified as experimental/ investigational and not medically necessary for all indications

DocumentationProviders may request review with robust clinical data to support medical necessity consideration

inv-168: Experimental/Investigational/Unproven — definition

Experimental/Investigational/Unproven — definitionProducts lacking sufficient peer‑reviewed evidence of clinical effectiveness are considered Experimental/Investigational/Unproven

ConsequenceNot reasonable and necessary; use is not covered absent substantive evidence

List statusPolicy maintains an illustrative list of such products and codes

inv-169: CAMP — definition and examples across product types

CAMP definitionCellular, acellular and matrix‑like products encompassing bioactive human skin allografts, acellular dermal matrices, amniotic membrane products and synthetic matrices

AliasesReferred to interchangeably as CAMP, CTP, or skin substitute grafts in guideline literature

Clinical roleUsed as adjunctive therapies when wounds fail to respond to SOC; product heterogeneity limits direct comparisons

inv-170: amnion/chorion membrane products — definition and context

Amnion/chorion membrane products — definitionHuman placental‑derived membranes (amnion/chorion) used as allografts to promote wound healing and reduce inflammation

Processing formsCryopreserved, dehydrated (dHACM), or fresh preparations used as patches, grafts, or injectable forms

IndicationsChronic lower extremity wounds, select ophthalmic uses, burns and surgical reconstructions when criteria are met

inv-171: acellular dermal matrix — definition and context

Acellular dermal matrix — definitionDermal graft products stripped of cellular elements providing a collagenous scaffold to support host cell ingrowth and dermal regeneration

Clinical usesUsed for wound closure, breast reconstruction (ADM), and burn management as a structural scaffold

Regulatory/cautionary notesVariable safety profiles; FDA has issued safety communications regarding ADM use in some reconstruction contexts

Evidence Summary and References

The policy cites numerous peer‑reviewed studies and systematic reviews in support of its clinical analyses; these references are provided for evidence context and do not themselves modify the policy coverage statements. The reference lists summarize trials, cohort studies, and reviews relevant to DFU, VLU, burns, and ophthalmic indications.

This evidence‑only section aggregates studies of cellular, acellular and matrix‑like products (CAMP) and related trials; it functions as the supporting literature base for the policy’s coverage and investigational determinations and does not by itself list coverage exclusions.

Policy History and Revision Notes

2024-07-17policy_history

Medicare Advantage policy established and initial UM Committee approval; interim coding adjustments later noted on 09/18/2024 (Q4116 and Q4182 relocated between indication lists).

2025-02-12interim_update

Interim update to align with MAC implementation of a newly published LCD for DFU and VLU: internal DFU/VLU coverage criteria and related coding/evidence sections were removed and readers referred to local LCD/LCA; foundational policy language updated.

2026-01-02interim_update

Policy history notes reversion to the 09/18/2024 policy due to delays in CMS LCD implementation and documents removal of the DFU/VLU LCD from the policy because it did not go live as anticipated on 2026-01-01.

2026-05-20interim_updateLatest

Interim update documenting multiple code status changes: removals (A6010, A6021, A6022, C1763, C1768, C1781, C5271-C5278, C9352, C9353, C9355, C9356, C9358, C9360, C9361, C9364, Q4106) and additions (G0681–G0684, Q4398–Q4429, Q4431–Q4433, Q4435–Q4440, A2040–A2045, C8002); CMS guidance and regulatory status language updated regarding 'incident-to-supplies'.

The policy history documents the removal of the Skin Substitutes Grafts/CTP LCD from parts of the history when anticipated CMS actions did not go live as planned. This entry is included in the policy history to document interim administrative changes.

The policy states repeatedly that its lists of non‑covered products are illustrative and subject to change over time; the list is not exhaustive and will be updated as new evidence becomes available. Providers should treat the listed products as examples and verify current policy status for other products not listed.