Amniotic Membrane and Amniotic Fluid — Medical Coverage Policy
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Defines medical necessity, noncoverage, and applicable HCPCS codes for human amniotic membrane (HAM) grafts, injections of micronized/particulate HAM, and amniotic fluid products for ophthalmic, wound, and musculoskeletal indications for BCBS Rhode Island Medicare Advantage and commercial products.
No material clinical or coverage changes in this revision.
Coverage Criteria
inv-01: Ophthalmic indications — medically necessary
Covered when filed with a covered diagnosis and for the specific indications below:
When used with suture or glue, HAM grafts may also be considered medically necessary for corneal perforation or pterygium repair.
inv-02: Not medically necessary / Not covered
Conditions and product types considered not covered / not medically necessary:
Applies to Medicare Advantage Plans (not covered) and Commercial Products (not medically necessary) as stated in the policy.
Medicare wording: 'not covered'; Commercial wording: 'not medically necessary'.
Policy distinguishes diabetic lower‑extremity ulcers (see wound care criteria) from venous insufficiency ulcers.
inv-03: Lower-extremity ulcer indications
Wound care indications:
Applies to Medicare Advantage Plans and Commercial Products when properly filed with a covered diagnosis.
Randomized controlled trials comparing HAM with standard care are needed.
inv-04: Musculoskeletal indications — not covered / not medically necessary
Musculoskeletal injections — evidence stance:
Policy states evidence is insufficient to determine effects on health outcomes.
Policy states evidence is insufficient to determine effects on health outcomes.
Injection of micronized or particulated human amniotic membrane (HAM) and injection of human amniotic fluid are excluded from coverage and are not covered / not medically necessary for all indications. This exclusion applies regardless of indication and includes, but is not limited to, uses such as osteoarthritis and plantar fasciitis.
Providers may not bill a member for services that are determined to be not medically necessary or that are non-covered benefits unless the member was informed and has provided written agreement in advance to accept financial responsibility. Verify member-specific benefits and refer to the member's subscriber agreement or employer agreement for applicable coverage rules.
For Commercial Products, injection of micronized or particulated human amniotic membrane and injection of human amniotic fluid are considered not medically necessary for all indications, including but not limited to osteoarthritis and plantar fasciitis, based on insufficient evidence of clinical benefit.
Services determined to be not medically necessary or that are non-covered benefits are not covered under this policy. Denials for such services may occur, and coverage decisions are subject to the member's benefit documents and applicable participation agreements.
Coding
| Q4132 | Grafix core and GrafixPL core, per square centimeter |
| Q4133 | Grafix prime and GrafixPL prime, per square centimeter |
| Q4137 | Amnioexcel or BioDExCel, per square centimeter |
| Q4138 | Biodfence Dryflex, per square centimeter |
| Q4139 | AmnioMatrix or BioDMatrix, injectable, 1 cc |
| Q4140 | Biodfence, per square centimeter |
| Q4145 | Epifix, injectable, 1 mg |
| Q4148 | Neox cord 1k, Neox cord RT, or Clarix cord 1K, per square centimeter |
| Q4150 | AlloWrap DS or dry, per square centimeter |
| Q4151 | AmnioBand or Guardian, per square centimeter |
| Q4218 | Surgicord, per square centimeter |
| Q4219 | Surgigraft-dual, per square centimeter |
| Q4220 | BellaCell HD or Surederm, per sq cm |
| Q4221 | Amniowrap2, per square centimeter |
| Q4227 | Amniocore, per square centimeter |
| Q4228 | BioNextPATCH, per square centimeter |
| Q4229 | Cogenex amniotic membrane, per square centimeter |
| Q4230 | Cogenex flowable amnion, per 0.5 cc |
| Q4231 | Corplex P, per cc |
| Q4232 | Corplex, per square centimeter |
| E08.621 | Diabetes mellitus due to underlying condition with foot ulcer |
| E08.622 | Diabetes mellitus due to underlying condition with other skin ulcer |
| H11.001 | Conjunctival hemorrhage, right eye (range referenced) |
| H16.001 | Keratitis, unspecified eye (range referenced) |
| E09.621 | Drug or chemical induced diabetes with foot ulcer |
| E10.621 | Type 1 diabetes with foot ulcer |
| E11.621 | Type 2 diabetes with foot ulcer |
| E13.621 | Other specified diabetes with foot ulcer |
| H04.121 | Epiphora, right lacrimal (range referenced) |
Provider Actions and Billing Guidance
Prior Authorization
Not applicable
Benefit Verification
Benefits may vary between groups and contracts. Providers should verify member-specific benefits, coverage, and eligibility prior to rendering services by referring to the member's Benefit Booklet, Evidence of Coverage, Subscriber Agreement, or by contacting the provider call center.
- Verify medical necessity and whether the service is a covered benefit for the member's specific contract.
- Call the provider call center for member-specific benefits and eligibility information.
Coding and Billing Guidance
The following HCPCS Q‑codes are used for specific amniotic products; when a specific HCPCS code does not exist for a product, use an appropriate unlisted code (for example, Q4100). Submit claims with the applicable HCPCS Q‑code and the appropriate ICD‑10 diagnosis code that supports medical necessity.
- Q4246 — Coretext or Protext, per cc
- Q4247 — Amniotext patch, per square centimeter
- Q4248 — Dermacyte Amniotic Membrane Allograft, per square centimeter
- Q4249 — Amniply, for topical use only, per square centimeter
- Q4250 — Amnioamp-mp, per square centimeter
- Q4251 — Vim, per square centimeter (effective 10/1/21)
- Q4252 — Vendaje, per square centimeter (effective 10/1/21)
- Q4253 — Zenith amniotic membrane, per square centimeter (effective 10/1/21)
- Q4254 — Novafix dl, per square centimeter
- Q4255 — Reguard, for topical use only, per square centimeter
- If no specific HCPCS exists for a product (e.g., AmnioFix or OrthoFlo), use an appropriate unlisted code such as Q4100.
Injection Products Not Covered
Injection of micronized or particulated human amniotic membrane and injection of human amniotic fluid is not covered/not medically necessary for all indications (including but not limited to osteoarthritis and plantar fasciitis). Requests for injection of micronized/particulated HAM or injection of amniotic fluid for any indication will be denied.
- Medicare Advantage: injection of micronized/particulated HAM and injection of amniotic fluid not covered for all indications.
- Commercial: injection of micronized/particulated HAM and injection of amniotic fluid considered not medically necessary for all indications.
Billing and Denial Risk
Services determined to be not medically necessary or not covered under the member's contract may be denied. Providers may not balance-bill members for denied services unless the member has been informed and provided written agreement to pay in advance, and unless permitted by the participation agreement. Refer to the provider participation agreement for applicable provisions.
- Denials may occur when services are not medically necessary or are non-covered benefits for the member's contract.
- Do not bill the member for denied services unless the member provided informed, written agreement to pay in advance and such billing is allowed under your participation agreement.
Background
Human amniotic membrane (HAM) consists of the amnion and chorion layers and, along with amniotic fluid, contains extracellular matrix components, growth factors, cytokines, and anti-inflammatory proteins. These materials are processed into different formulations — including patches, flowable/injectable suspensions, and particulate preparations — and are proposed to support wound healing and modulate inflammation. HAM grafts have established ophthalmic uses for certain corneal surface disorders, while injectable or particulate HAM and amniotic fluid formulations are being evaluated for wound care and musculoskeletal conditions; however, evidence is currently insufficient to support many injectable indications.
Definitions
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