CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Amniotic Membrane and Amniotic Fluid

Coverage and medical necessity guidance for use of human amniotic membrane (HAM) products and amniotic fluid formulations across wound care and selected ophthalmic and musculoskeletal indications for BlueCHiP for Medicare and Commercial products.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyAmniotic Membrane and Amniotic Fluid

Policy CodePolicy N/A

Change TypeNo material change

Effective DateSep 1, 2018

Next Review DateN/A

Key ActionFor member-specific benefits and eligibility, contact the provider call center and verify benefits prior to providing services.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

11HCPCS Q-codes

5 productsMedically necessary examples

MultipleIndications evaluated

25References

Coverage and Medical Necessity Criteria

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Diabetic lower-extremity ulcer coverage: Treatment of nonhealing diabetic lower-extremity ulcers using a patch or flowable formulation of specified human amniotic membrane (HAM) products (for example, AmnioBand Membrane, Biovance, EpiFix, Grafix) may be considered medically necessary.

Evidence demonstrates meaningful improvement versus standard care and outcomes at least as good as established advanced wound care products.

Ophthalmic indications (sutured HAM)

Covered when ALL of the following are met:

Sutured HAM for specific ophthalmic conditions: Sutured human amniotic membrane grafts are used for treatment of corneal surface disorders including neurotrophic keratitis, corneal ulcers and melts, pterygium repair, Stevens-Johnson syndrome, and persistent epithelial defects.

Use of a HAM graft fixated by sutures is an established treatment for these corneal surface disorders.

Not covered / Insufficient evidence

Not covered or insufficient evidence: Injection of micronized or particulated HAM and injection of amniotic fluid are not covered / considered not medically necessary for all indications; human amniotic membrane without suture (eg, Prokera®, AmbioDisk™) for ophthalmic indications is not covered / not medically necessary; evidence is insufficient for use of HAM in venous ulcers, injections for knee osteoarthritis, injections for plantar fasciitis, and many ophthalmic uses beyond the specified sutured indications.

Multiple sections state insufficient evidence or not medically necessary determinations for these indications.

This policy applies to the use of human amniotic membrane (HAM) products and amniotic fluid formulations across wound care and selected ophthalmic and musculoskeletal indications. For surgical grafting to the corneal surface, sutured HAM grafts are addressed separately and may be considered medically necessary for specified ophthalmic conditions (see coverage criteria). However, injection-based uses are handled differently: the policy states that injection of micronized or particulated human amniotic membrane and injection of human amniotic fluid is not covered for all indications under Medicare and is considered not medically necessary for all indications under Commercial products due to insufficient evidence of clinical benefit.

Distinctions by product line and payer are important. Specifically, the policy identifies Human amniotic membrane without suture (for example, Prokera® or AmbioDisk™) as not covered for ophthalmic indications under BlueCHiP for Medicare and not medically necessary for Commercial products. Providers should follow the detailed coverage criteria for wound and sutured ophthalmic applications and note the explicit noncoverage / NMN determinations for injection and nonsutured ophthalmic devices.

Services determined to be not medically necessary or otherwise non-covered under this medical policy are subject to the member's subscriber agreement and benefit documents. Benefits and eligibility are determined by the member's subscriber agreement or member certificate and/or the employer agreement, which supersede this policy. For member-specific benefits, contact the provider call center prior to providing services.

For Commercial products this policy explicitly states that human amniotic membrane without suture (eg, Prokera®, AmbioDisk™) for ophthalmic indications is not medically necessary. For BlueCHiP for Medicare the same nonsutured devices are described as not covered because the evidence is insufficient to determine health outcomes. These specific devices should not be billed as covered ophthalmic treatments under the respective product lines.

When a service is determined to be not medically necessary or a non-covered benefit, the provider’s billing and collection obligations are governed by the member’s benefit documents and participation agreements. If you provide services that are determined to not be medically necessary (or are non-covered benefits), you may not charge the member unless they have been informed and have agreed in writing in advance to continue treatment at their own expense. Refer to your participation agreement for applicable provisions and contact the provider call center for member-specific guidance.

Coding and Diagnosis Guidance

Recognized HCPCS Q-codesHCPCS

Q4186	Epifix, per square centimeter
Q4187	Epicord, per square centimeter
Q4188	Amnioarmor, per square centimeter
Q4189	Artacent ac, 1 mg
Q4190	Artacent ac, per square centimeter
Q4191	Restorigin, per square centimeter
Q4192	Restorigin, 1 cc
Q4194	Novachor, per square centimeter
Q4198	Genesis amniotic membrane, per square centimeter
Q4201	Matrion, per square centimeter

1–10 of 11

1/2

Unlisted code guidanceHCPCS

Q4100

Unlisted biologics code (example for products without specific HCPCS)

ICD-10 Diagnosis Codes that may support medical necessityICD-10

E08.621-E08.622	Diabetes mellitus due to underlying condition with foot ulcer (range listed)
E09.621-E09.622	Drug or chemical induced diabetes with foot ulcer (range listed)
E10.621-E10.622	Type 1 diabetes with foot ulcer (range listed)
E11.621-E11.622	Type 2 diabetes with foot ulcer (range listed)
E13.621-E13.622	Other specified diabetes with foot ulcer (range listed)
H11.001-H11.069	Conjunctival disorders (range listed)
H16.001-H16.079	Keratitis (range listed)
H16.231-H16.239	Corneal disorders (range listed)
H18.831-H18.839	Other specified corneal disorders (range listed)

Provider Responsibilities and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization: Not applicable.

Note

Benefit Variability

Benefits may vary by contract. Refer to the member's Benefit Booklet, Evidence of Coverage, or Subscriber Agreement for applicable benefits and coverage determinations.

Note

Prior Authorization / Benefit Verification

For member-specific benefits and eligibility, contact the provider call center. Member benefits govern coverage and supersede this policy.

Provider call center for member-specific benefits/eligibility

Documentation Required

Supporting Diagnosis Codes

ICD-10 diagnosis codes that may support medical necessity (examples):

E08.621-E08.622
E09.621-E09.622
E10.621-E10.622
E11.621-E11.622
E13.621-E13.622
H11.001-H11.069
H16.001-H16.079
H16.231-H16.239
H18.831-H18.839

Denial Risk

Not Covered / Not Medically Necessary

Human amniotic membrane without suture (eg, Prokera®, AmbioDisk™) for ophthalmic indications is not covered / not medically necessary; injection of micronized/particulated human amniotic membrane and injection of human amniotic fluid are not covered for all indications. If services are determined not medically necessary or are non-covered benefits, providers may not charge the member unless the member was informed and agreed in writing in advance.

Note

Provider Action Note

Click the envelope icon in the policy portal to submit comments. This policy is informational and not a guarantee of payment. BCBSRI may review and revise policies at any time.

Clinical Background and Scope

Human amniotic membrane (HAM) is composed of two conjoined layers—the amnion and chorion—that form the innermost lining of the placenta. HAM products are processed and preserved (commonly cryopreserved or dehydrated) and are available in several formats, including patches or grafts, suspensions, and particulates. HAM contains structural proteins (eg, collagen), growth factors, cytokines, and anti-inflammatory proteins and is used to support wound healing and corneal surface reconstruction.

Processing methods and product configuration affect intended use and coverage: sutured HAM grafts are used as corneal surface grafts for specific ophthalmic conditions, whereas nonsutured devices (for example, Prokera® or AmbioDisk™) and injected micronized/particulated HAM or amniotic fluid have been determined to lack sufficient evidence and are classified as not covered or not medically necessary for the indicated payer populations.

Key Definitions

Human amniotic membrane (HAM) — definition and key attributes

DefinitionTwo conjoined layers (amnion and chorion) forming the innermost lining of the placenta; harvested after birth, cleaned, sterilized, and preserved (cryopreserved or dehydrated) for use as an allograft.

Common formulationsAvailable as patches (wound covers), suspensions, particulates, or connective tissue extractions for topical application or injection.

Biologic componentsContains collagen, fibronectin, hyaluronic acid, growth factors, cytokines, and anti-inflammatory proteins (eg, interleukin-1 receptor antagonist).

Putative actionsBelieved to have anti-inflammatory, antifibroblastic, antimicrobial, and regenerative properties and is considered nonimmunogenic.

Processing and availabilityProducts may be cryopreserved or dehydrated; evidence shows some dehydrated products elute growth factors and stimulate mesenchymal stem cell migration in preclinical studies.

Amniotic fluid — definition and investigational injectable formulations

DefinitionFluid surrounding the fetus containing proteins, carbohydrates, peptides, fats, enzymes, hormones, pigments, and fetal cells.

Physiologic originIn later gestation, largely derived from fetal urine and secretions from the fetal respiratory and gastrointestinal tracts.

Therapeutic evaluationAmniotic fluid and amniotic fluid–derived cells are under investigation as injectable therapies for osteoarthritis and plantar fasciitis.

Comparative propertiesHas been compared with synovial fluid; contains hyaluronan, lubricant, cholesterol, and cytokines.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyAmniotic Membrane and Amniotic Fluid

Policy CodePolicy N/A

Change TypeNo material change

Effective DateSep 1, 2018

Next Review DateN/A

Key ActionFor member-specific benefits and eligibility, contact the provider call center and verify benefits prior to providing services.

SourceLink

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