CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Medical Coverage Policy | Amniotic Membrane and Amniotic Fluid

Defines medical necessity and noncoverage determinations for human amniotic membrane (HAM) grafts/patches and injectable/flowable amniotic products across Medicare Advantage and Commercial products, listing covered ophthalmic indications and coverage for nonhealing diabetic lower-extremity ulcers; states noncoverage/not medically necessary uses for other indications including injections for osteoarthritis and plantar fasciitis.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyMedical Coverage Policy | Amniotic Membrane and Amniotic Fluid

Policy CodePolicy N/A

Change TypeClarified (no material clinical changes)

Effective DateJun 5, 2024

Next Review Date

Key ActionClaims for covered HAM procedures/products must be filed with a covered ICD-10 diagnosis code as referenced in the policy.

SourceLink

POLICY UPDATE CHANGES

Policy effective dates include 07/01/2023 and 06/05/2024 listed in header.

1Indication(s) with sufficient evidence (diabetic foot ulcers)

4Ophthalmic indications with sufficient evidence

8Indications with insufficient evidence (examples)

2Common noncovered injectable uses

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Coverage Summary

Scope: This policy defines medical necessity and noncoverage determinations for human amniotic membrane (HAM) grafts/patches and injectable/flowable amniotic products across Medicare Advantage and Commercial products, listing covered ophthalmic indications and coverage for nonhealing diabetic lower-extremity ulcers. Effective date: 06/05/2024 (policy header also lists 07/01/2023).

Coverage stance: mixed — certain uses (eg, patch/flowable HAM for nonhealing diabetic lower‑extremity ulcers and specific ophthalmic indications) may be considered medically necessary when filed with a covered diagnosis, while many other uses (including injections of micronized/particulate HAM or amniotic fluid and other indications such as venous insufficiency ulcers) are listed as not covered or not medically necessary.

Thresholds and Key Statistics

Nonhealing ulcer definition (trial inclusion)<20% healing after ≥2 weeks of standard care

Stat - diabetic foot ulcers (sufficient evidence)1 indication with sufficient evidence (diabetic foot ulcers); RCTs and registries show improved wound closure vs standard care

Stat - ophthalmic indications (sufficient evidence)4 ophthalmic indications with sufficient evidence (corneal ulcers/melts; corneal perforation temporary; Stevens-Johnson syndrome; severe dry eye)

Stat - indications with insufficient evidence8 indications with insufficient evidence (examples listed: venous ulcers, osteoarthritis injections, plantar fasciitis, neurotrophic keratitis, etc.)

Stat - common noncovered injectable uses2 common noncovered injectable uses (osteoarthritis, plantar fasciitis)

Medically Necessary – Covered Indications

Medicare Advantage Plans and Commercial Products - Covered Indications

Treatment is considered medically necessary when filed with a covered diagnosis identified below:

ALL of the following

Treatment of nonhealing diabetic lower-extremity ulcers using human amniotic membrane products
Ophthalmic indications (HAM grafts with or without suture)
- Neurotrophic keratitis
- Corneal ulcers and melts
- Corneal perforation

Noncovered and Not Medically Necessary Uses

Medicare Advantage Plans - Not Covered

Not covered when evidence is insufficient as specified below:

ANY of the following

HAM grafts with or without suture for ophthalmic indications not outlined in covered list
Injection of micronized or particulated human amniotic membrane for all indications (including but not limited to osteoarthritis and plantar fasciitis)
Injection of human amniotic fluid for all indications (including but not limited to osteoarthritis and plantar fasciitis)
All other HAM products and indications not listed above (including treatment of lower-extremity ulcers due to venous insufficiency)

Clinical Evidence-Based Determinations (by indication)

Summary of evidence sufficiency for outcomes by indication:

ANY of the following

Nonhealing diabetic lower-extremity ulcers: Evidence sufficient to determine improvement in net health outcome for patch/flowable HAM products (RCTs and registries)
Lower-extremity ulcers due to venous insufficiency: Evidence insufficient (mixed RCT results, methodological concerns)
Knee osteoarthritis (injection of suspension/particulate HAM or amniotic fluid): Evidence insufficient (feasibility/pilot data only)
Plantar fasciitis (injection of micronized HAM): Evidence insufficient (interim results, further follow-up needed)

Coding

HCPCS codes considered medically necessary when filed with listed ICD-10 diagnosis codes (see attached list)HCPCSCovered

No codes listed

Provider Actions / Billing Guidance

Documentation Required

File with covered diagnosis

Claims for covered human amniotic membrane (HAM) procedures/products must be filed with a covered ICD-10 diagnosis code as referenced in the policy (see attached HCPCS/ICD-10 lists).

See attached HCPCS/ICD-10 lists

Denial Risk

Not covered / not medically necessary services

Services listed as not covered or not medically necessary in the policy may be denied as not medically necessary.

Injection of micronized or particulated human amniotic membrane (eg, for osteoarthritis or plantar fasciitis)
Injection of human amniotic fluid (eg, for osteoarthritis or plantar fasciitis)
Treatment of lower-extremity ulcers due to venous insufficiency

Background

Background: Human amniotic membrane (HAM) and amniotic fluid products are available as patches, topical applications, suspensions/particulates, or injections and are being evaluated across wound care, ophthalmology, orthopedics, and other conditions. HAM (amnion and chorion) is harvested after birth, cleaned, sterilized, and cryopreserved or dehydrated for use as an allograft; fresh HAM contains collagen, fibronectin, hyaluronic acid, growth factors, cytokines, and anti-inflammatory proteins and is believed to have anti‑inflammatory, antifibroblastic, antimicrobial, and regenerative potential and to be nonimmunogenic. Amniotic fluid contains proteins, hyaluronan, and cytokines and is being explored for orthopedic injections. Clinical evidence varies by indication: randomized controlled trials and registries support patch/flowable HAM for nonhealing diabetic lower‑extremity ulcers, preliminary or interim studies limit conclusions for injections (knee osteoarthritis, plantar fasciitis), and evidence sufficiency for ophthalmic conditions differs by specific diagnosis.

Revision History

2023-07-01policy_effective

Policy effective date listed in header.

2024-06-05policy_effectiveLatest

Policy effective date listed in header.

2024-08publicationLatest

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyMedical Coverage Policy | Amniotic Membrane and Amniotic Fluid

Policy CodePolicy N/A

Change TypeClarified (no material clinical changes)

Effective DateJun 5, 2024

Next Review Date

Key ActionClaims for covered HAM procedures/products must be filed with a covered ICD-10 diagnosis code as referenced in the policy.

SourceLink

On This Page

Partial limbal stem cell deficiency with extensive diseased tissue

Moderate or severe Stevens-Johnson syndrome

Persistent epithelial defects

Moderate or severe acute ocular chemical burn

Ophthalmic indications (HAM grafts with suture or glue)

Corneal perforation
Pterygium repair

All other indications not listed above (including repair following Mohs micrographic surgery and lower-extremity ulcers due to venous insufficiency)

Commercial Products - Not Medically Necessary

Considered not medically necessary when evidence is insufficient as specified below:

ANY of the following

HAM grafts with or without suture for ophthalmic indications not outlined in covered list
Injection of micronized or particulated human amniotic membrane for all indications (including but not limited to osteoarthritis and plantar fasciitis)
Injection of human amniotic fluid for all indications (including but not limited to osteoarthritis and plantar fasciitis)
All other HAM products and indications not listed above (including treatment of lower-extremity ulcers due to venous insufficiency)
All other indications not listed above (including repair following Mohs micrographic surgery and lower-extremity ulcers due to venous insufficiency)

Neurotrophic keratitis: Evidence insufficient (RCT showed no benefit vs tarsorrhaphy or bandage contact lens)

Corneal ulcers and melts: Evidence sufficient (systematic review, nonrandomized comparative data show healing and vision improvement)

Corneal perforation with active inflammation after corneal transplant requiring adjunctive treatment: Evidence insufficient

Bullous keratopathy (palliative in non-candidates for curative treatment): Evidence insufficient (RCT showed no advantage over stromal puncture for pain)

Partial limbal stem cell deficiency with extensive diseased tissue: Evidence insufficient (no comparative trials)

Moderate or severe Stevens-Johnson syndrome: Evidence sufficient (RCT showed improved symptoms and function)

Persistent epithelial defects and ulceration unresponsive to conservative therapy: Evidence insufficient (no comparative trials)

Severe dry eye with ocular surface damage/inflammation unresponsive to conservative therapy: Evidence sufficient (RCT and large case series show symptom reduction and corneal improvements)

Moderate or severe acute ocular chemical burns: Evidence insufficient (3 RCTs with mixed results)

Corneal perforation when corneal tissue not immediately available: Evidence sufficient (HAM may provide temporary coverage)

Pterygium repair when insufficient healthy tissue for conjunctival autograft: Evidence insufficient (systematic reviews show autograft superior to HAM for recurrence reduction)

Repair following Mohs micrographic surgery: Evidence insufficient (nonrandomized comparative study; prospective studies lacking)

Evidence summary

Definitions

Ophthalmic uses not outlined in the covered ophthalmic indications in the policy

Provider Update published (document notes multiple Provider Updates; no explicit clinical policy changes).

clarification

Document shows multiple published Provider Updates but contains no explicit clinical policy changes noted in revision history (non-material clarification).