Colorado Rocky Mountain Health Plans skin substitutes Coverage

Coverage criteria and medical necessity

General coverage determination rules

Coverage is determined by reasonable and necessary criteria and applicable Medicare LCDs/LCAs where present.

Medicare alignment: All integral components of a billed service must meet the SSA §1862(a)(1)(A) reasonable and necessary standard; if a skin substitute/CTP is not reasonable and necessary, associated application services are also not reasonable and necessary.

Refer to Medicare source materials listed in policy (SSA §1862(a)(1)(A); Medicare Benefit Policy Manual; Medicare Program Integrity Manual).

LCD/LCA compliance: Medicare does not have an NCD for many amniotic/placental or skin substitute products; Local Coverage Determinations (LCDs)/Local Coverage Articles (LCAs) exist and compliance with these contractor policies is required where applicable.

See LCD/LCA tables referenced in policy for state-specific guidance.

Reference when no LCD/LCA: For states/territories with no applicable LCDs/LCAs or for indications not listed in existing LCDs/LCAs (other than breast reconstruction), UnitedHealthcare internal coverage criteria and related commercial/Medicare Advantage policies are used as noted in this document.

UnitedHealthcare internal criteria are applied when Medicare source materials are absent or allow flexibility.

Medicare Reasonable and Necessary and Internal Criteria

Covered when services and all integral components meet Medicare reasonable and necessary standards and applicable internal criteria:

Medicare standard: All integral components of a billed skin substitute/CTP service must meet the reasonable and necessary standard under SSA §1862(a)(1)(A).

If a product is not reasonable and necessary, associated application services are also not reasonable and necessary.

Use of Medicare source materials: When Medicare statutes, regulations, NCDs, or LCDs provide coverage criteria, those Medicare materials apply; where absent or explicitly flexible, UnitedHealthcare internal coverage criteria based on evaluation of the clinical evidence are applied.

Internal criteria were developed through review of clinical evidence and applicable Medicare documents.

Coverage of application or delivery services for skin substitutes/Cellular and Tissue-Based Products (CTPs) follows Medicare's reasonable and necessary standard under SSA §1862(a)(1)(A). If the primary skin substitute/CTP is determined not to be reasonable and necessary, the associated application, placement, or delivery services are likewise considered not reasonable and necessary and are excluded from coverage.

Where a Medicare National Coverage Determination (NCD), Local Coverage Determination (LCD), or Local Coverage Article (LCA) applies to a product or indication, follow that contractor-specific guidance for coverage, coding, and prior authorization. Medicare does not have an NCD for many amniotic/placental derived or other skin substitute products; when no contractor guidance exists for a state or indication, this policy's Coverage Rationale and internal criteria should be used to determine medical necessity.

Services and any integral application components that fail the Medicare reasonable and necessary test under SSA §1862(a)(1)(A) are excluded from coverage. The policy operationalizes this Medicare standard by requiring that all billed service components (product plus application/placement service) meet the reasonable and necessary requirement; failure of the product to meet that standard excludes the associated service components.

Medicare does not have a National Coverage Determination for amniotic and placental derived product injections and/or applications for musculoskeletal, non‑wound indications. Local Coverage Determinations/Articles exist in many jurisdictions and must be followed where applicable; in their absence, use the Coverage Rationale in this policy and applicable internal criteria to assess medical necessity.

This policy reiterates the Medicare-based principle that when a skin substitute or CTP is determined not to be reasonable and necessary, the related application or placement services are considered not medically necessary. Providers should ensure the primary product meets SSA §1862(a)(1)(A) standards before billing associated application services to avoid denials.

Applicable procedure and product codes

Applicable HCPCS A-codes (partial list)HCPCS

A2001	InnovaMatrix AC, per sq cm (add-on, list separately in addition to primary procedure)
A2002	Mirragen Advanced Wound Matrix, per sq cm (add-on, list separately in addition to primary procedure)
A2004	XCelliStem, 1 mg
A2005	Microlyte Matrix, per sq cm (add-on, list separately in addition to primary procedure)
A2006	NovoSorb SynPath dermal matrix, per sq cm (add-on, list separately in addition to primary procedure)

Applicable HCPCS A-codes and device code (continued)HCPCS

A2026	Restrata MiniMatrix, 5 mg
A2027	MatriDerm, per sq cm (add-on, list separately in addition to primary procedure)
A2030	Miro3D fibers, per mg
A2031	MiroDry Wound Matrix, per sq cm (add-on, list separately in addition to primary procedure)
A4100	Nonsheet form skin substitute, FDA-cleared as a device, not otherwise specified (list in addition to primary procedure)

Applicable HCPCS Q-codes (selected examples across list)HCPCS

Q4100	Skin substitute, not otherwise specified (Deleted 1/1/2026)
Q4110	PriMatrix, per sq cm (add-on, list separately in addition to primary procedure)
Q4112	Cymetra, injectable, 1 cc
Q4114	Integra flowable wound matrix, injectable, 1 cc
Q4145	EpiFix, injectable, 1 mg
Q4162	WoundEx Flow, BioSkin Flow, 0.5 cc
Q4192	Restorigin, 1 cc
Q4226	MyOwn Skin, includes harvesting and preparation procedures, per sq cm
Q4231	Corplex p, per cc (Deleted 03/31/2025, see A2035)
Q4248	Dermacyte Amniotic Membrane Allograft, per sq cm (add-on, list separately in addition to primary procedure)

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Applicable Q-codes (sample group 1)HCPCS

Q4282	Cygnus Dual, per sq cm (add-on, list separately in addition to primary procedure)
Q4283	Biovance Tri-Layer or Biovance 3L, per sq cm (add-on, list separately in addition to primary procedure)
Q4284	DermaBind SL, per sq cm (add-on, list separately in addition to primary procedure)
Q4287	DermaBind DL, per sq cm (add-on, list separately in addition to primary procedure)
Q4288	DermaBind CH, per sq cm (add-on, list separately in addition to primary procedure)
Q4289	RevoShield+ Amniotic Barrier, per sq cm (add-on, list separately in addition to primary procedure)
Q4290	Membrane Wrap-Hydro, per sq cm (add-on, list separately in addition to primary procedure)
Q4291	Lamellas XT, per sq cm (add-on, list separately in addition to primary procedure)
Q4292	Lamellas, per sq cm (add-on, list separately in addition to primary procedure)
Q4293	Acesso DL, per sq cm (add-on, list separately in addition to primary procedure)

Applicable Q-codes (sample group 2)HCPCS

Q4294	Amnio Quad-Core, per sq cm (add-on, list separately in addition to primary procedure)
Q4301	Activate Matrix, per sq cm (add-on, list separately in addition to primary procedure)
Q4310	Procenta, per 100 mg

Applicable Q-codes (continued)HCPCS

Q4312	Acesso AC, per sq cm (add-on, list separately in addition to primary procedure)
Q4336	Artacent C, per sq cm (add-on, list separately in addition to primary procedure)
Q4340	SimpliGraft, per sq cm (add-on, list separately in addition to primary procedure)
Q4355	Abiomend Xplus Membrane and Abiomend Xplus Hydromembrane, per sq cm (add-on, list separately in addition to primary procedure)
Q4378	Renew FT Matrix, per sq cm (add-on, list separately in addition to primary procedure)
Q4396	Natalin, per sq cm (add-on, list separately in addition to primary procedure)
Q4402	XWRAP 2.0, per sq cm (add-on, list separately in addition to primary procedure)
Q4412	CHORIOFIX, per sq cm (add-on, list separately in addition to primary procedure)
Q4413	Cygnus Solo, per sq cm (add-on, list separately in addition to primary procedure)
Q4420	NuForm, per sq cm (add-on, list separately in addition to primary procedure)

Applicable HCPCS product codes addedHCPCS

Q4398	Summit AC, per sq cm (add-on, list separately in addition to primary procedure)
Q4399	Summit FX, per sq cm (add-on, list separately in addition to primary procedure)
Q4400	Polygon3 Membrane, per sq cm (add-on, list separately in addition to primary procedure)
Q4401	Absolv3 Membrane, per sq cm (add-on, list separately in addition to primary procedure)
Q4402	XWRAP 2.0, per sq cm (add-on, list separately in addition to primary procedure)
Q4403	XWRAP Dual Plus, per sq cm (add-on, list separately in addition to primary procedure)
Q4404	XWRAP Hydro Plus, per sq cm (add-on, list separately in addition to primary procedure)
Q4405	XWRAP Fenestra Plus, per sq cm (add-on, list separately in addition to primary procedure)
Q4406	XWRAP Fenestra, per sq cm (add-on, list separately in addition to primary procedure)
Q4407	XWRAP Tribus, per sq cm (add-on, list separately in addition to primary procedure)

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Coding guidance sourcesmixed

No codes listed

Billing unit guidance

Typical billing unitMost skin substitute and CTP HCPCS Q-codes are billed per square centimeter (per sq cm)

Exceptions (per weight)Some products are billed by weight — e.g., Q4310 (Procenta) is billed per 100 mg

A-code billing examplesSeveral A‑codes in the policy (A2001–A2031, A4100, etc.) are specified per sq cm or per mg consistent with product descriptions

Provider requirements, prior authorization, and documentation

Prior Authorization

Prior Authorization Required / LCD Compliance

Prior authorization is required when specified by the member's plan or applicable Medicare LCD/LCA. Where an LCD/LCA exists for a state/territory or specific indication, follow the contractor's prior authorization and billing instructions. If the Medicare Advantage plan delegates utilization management or prior authorization to a third party, providers must follow the delegate's requirements.

Follow applicable LCDs/LCAs and contractor guidance for the member's jurisdiction.
When no LCD/LCA exists for an indication (other than breast reconstruction), refer to the related Commercial or Medicare Advantage policies noted in the Coverage Rationale.
If a delegate manages prior authorization for the member's MA plan, follow the delegate's requirements.

Denial Risk

Denial Risk When Component Is Not Reasonable and Necessary

Medicare requires that all integral components of a billed service meet the reasonable and necessary standard under SSA §1862(a)(1)(A). If a skin substitute or CTP is determined not reasonable and necessary, any associated application or ancillary services are also not reasonable and necessary and may be denied.

Policy background and scope

Background: Medicare reasonable and necessary rules apply to skin substitutes and CTPs. All integral components of a billed service must meet the reasonable and necessary test under SSA §1862(a)(1)(A); if the product is not reasonable and necessary, related application services are excluded. The policy update dated 06/01/2026 explicitly adds this operational language and references the relevant CMS manuals and statutes.

Terminology

CTP / Skin substitutes — definitions & policy notes

Skin substitutes / graftsProducts used as skin substitutes or grafts for wound care; Medicare has no national NCD for these products; applicable LCDs/LCAs must be followed where they exist

Associated application servicesApplication or ancillary services tied to a skin substitute/CTP are excluded when the primary product is not reasonable and necessary under SSA §1862(a)(1)(A)

Policy cross-referenceFor indications or states without LCDs/LCAs (other than breast reconstruction), refer to UnitedHealthcare commercial or Medicare Advantage policies listed in the document

Cellular and/or Tissue‑Based Products (CTPs) — terminology

CTP terminology scope'Cellular and/or Tissue‑Based Products (CTPs)' describes products inclusive of current and future technologies, adopted by the wound care community and contractors

OpenPayer

Skin Substitutes Grafts/Cellular and Tissue-Based Products (Injections and/or Applications)

Coverage criteria and medical necessity

Applicable procedure and product codes

Provider requirements, prior authorization, and documentation

Policy background and scope

Terminology