Amniotic Membrane and Amniotic Fluid
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Coverage and medical necessity determinations for human amniotic membrane (HAM) and amniotic fluid products used for wound care, ophthalmic, orthopedic, and other indications for Blue Cross Blue Shield - Rhode Island members.
No material clinical or coverage changes in this revision.
Coverage and Medical Necessity Criteria
Medically necessary indications
Covered when ALL of the following are met (for listed indications):
Randomized controlled trials and registries for specific HAM/placental products (eg, Affinity, AmnioBand Membrane, Biovance, EpiCord, EpiFix, Grafix) demonstrated improved wound closure and outcomes compared with standard care or are at least as good as established advanced wound care products.
Evidence strength varies by indication; some ophthalmic indications have sufficient evidence from RCTs or systematic reviews to support use.
Surgical application (suture or glue) is specified in the policy; standard corneal transplantation remains standard when tissue is available.
Not covered / Not medically necessary
Not covered / Not medically necessary when ANY of the following apply:
Policy cites insufficient evidence to demonstrate improvement in net health outcome for injectable formulations.
Policy explicitly states these uses lack sufficient evidence to determine benefit.
Some RCTs and reviews found insufficient or no benefit for certain ophthalmic indications outside the listed supported conditions.
Existing RCTs have mixed or methodologic limitations and additional corroborating well-designed trials are needed.
Covered with evidence
Indications with sufficient evidence to conclude improvement in net health outcome
Large RCTs are unlikely due to rarity and severity of the disease.
Conditionally beneficial / supported
Indications where evidence supports use in specific circumstances
Standard treatment remains corneal transplantation when tissue is available.
Reported duration of benefit up to 3 months.
Not enough evidence / Insufficient
Indications with insufficient evidence to conclude benefit
HAM may not be preferred when simpler equivalent procedures are available.
HAM may be considered when insufficient healthy tissue exists for autograft.
Well-designed prospective studies are lacking.
All other human amniotic membrane (HAM) products and indications not specifically identified as medically necessary in this policy are not covered / not medically necessary. This includes, but is not limited to, uses such as treatment of lower‑extremity ulcers due to venous insufficiency and other indications that are not listed as covered above.
For pterygium repair, evidence from randomized trials and systematic reviews indicates that conjunctival or limbal autograft is more effective than human amniotic membrane (HAM) graft at reducing recurrence. When sufficient healthy conjunctival tissue is available for autograft, autograft is the preferred approach and HAM is not the preferred alternative.
Members’ benefits and eligibility are governed by the member’s subscriber agreement, member certificate, and/or employer agreement. These documents supersede this medical policy; providers should verify member‑specific benefits and prior authorization requirements through the provider call center or benefit booklet before rendering services.
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, because available evidence is insufficient to demonstrate an improvement in net health outcome.
A randomized controlled trial in patients with bullous keratopathy found no advantage of sutured HAM over stromal puncture for palliation of pain. Given the lack of demonstrated benefit versus a simpler procedure, use of sutured HAM for palliation in this setting may be considered not medically necessary.
Coding and Documentation Requirements
| HCPCS codes identified in the attached list | HCPCS codes considered medically necessary when filed with the ICD-10 diagnosis codes included in the attached list |
Provider Responsibilities, Prior Authorization, and Billing
Prior authorization and benefit verification
Prior authorization: Not applicable per this policy excerpt. Providers must still refer to the member’s Benefit Booklet, Evidence of Coverage, or Subscriber Agreement for plan-specific requirements and verify benefits with the payer.
- Policy states: "Not applicable" for prior authorization.
- Benefits may vary by contract; refer to the Benefit Booklet/Evidence of Coverage/Subscriber Agreement.
- For member-specific benefits, contact the provider call center (see Provider Notice).
HCPCS/ICD-10 pairing requirement
File the listed HCPCS procedure codes only when accompanied by one of the ICD-10 diagnosis codes included in the policy’s attached list; coverage is tied to that HCPCS/ICD-10 pairing.
- "The HCPCS codes identified in the attached list are considered medically necessary when filed with the ICD10 diagnosis codes also included in the attached list."
- Covered indications (eg, diabetic lower‑extremity ulcers, specific ophthalmic diagnoses) must be filed with a covered diagnosis.
Verify member-specific benefits and prior authorization
For member-specific benefit or prior authorization questions, contact the payer’s provider call center and verify eligibility and benefits prior to providing services.
- Provider notice: "For information on member-specific benefits, call the provider call center."
- Benefits and eligibility are determined by the member’s subscriber agreement or employer agreement and may supersede this policy.
Requirement for prior standard care (nonhealing ulcers)
Coverage for nonhealing diabetic lower‑extremity ulcers is based on RCTs that compared HAM to standard care or established advanced wound care products; these trials enrolled ulcers defined as <20% healing after ≥2 weeks of standard care, so prior adequate standard care is expected.
- RCTs evaluated HAM versus standard care or established advanced wound care products.
- Trials used nonhealing definition: <20% healing after ≥2 weeks of standard care; coverage tied to that context.
Preferred surgical approach for pterygium
For pterygium repair, conjunctival or limbal autograft is considered more effective than HAM graft at reducing recurrence; autograft is preferred when sufficient healthy tissue exists.
- Systematic reviews of RCTs found conjunctival or limbal autograft more effective than HAM for reducing pterygium recurrence.
- Policy: "HAM is not preferred when sufficient healthy tissue exists for autograft."
Step therapy — none specified
No step therapy requirements are specified in this excerpt of the policy.
- Policy text does not list any formal step therapy protocols beyond evidence/context requirements for specific indications.
Diagnosis must be filed with claims
Claims for HAM treatments intended for nonhealing diabetic lower‑extremity ulcers must be filed with a covered ICD‑10 diagnosis; treatment is considered medically necessary only when filed with a covered diagnosis listed in the policy.
- "Treatment of nonhealing diabetic lower‑extremity ulcers using human amniotic membrane products may be considered medically necessary when filed with a covered diagnosis identified below."
- Providers must ensure the diagnosis submitted matches the policy’s covered diagnoses for the indication.
Required coding documentation and coding linkage
Providers must submit the HCPCS procedure codes from the policy’s attached list together with the ICD‑10 diagnosis codes from the attached list; failure to link the HCPCS code with a listed ICD‑10 diagnosis may result in denial.
- "The HCPCS codes identified in the attached list are considered medically necessary when filed with the ICD10 diagnosis codes also included in the attached list."
- The policy warns that claims for HCPCS codes not filed with the ICD‑10 diagnosis codes included in the attached list risk denial.
Verify member benefits and subscriber agreement
Verify eligibility and benefits before rendering services; the member’s subscriber agreement or employer agreement governs benefits and may supersede this policy.
- "For information on member-specific benefits, call the provider call center."
- "Benefits and eligibility are determined by the member's subscriber agreement or member certificate and/or the employer agreement, and those documents will supersede the provisions of this medical policy."
Denied: injectable HAM and amniotic fluid
Injection of micronized or particulated human amniotic membrane and injection of human amniotic fluid are not covered/not medically necessary for all indications (including osteoarthritis and plantar fasciitis); do not bill these injectable uses as covered services.
- Medicare Advantage: "Injection of micronized or particulated human amniotic membrane and injection of human amniotic fluid is not covered for all indications..."
- Commercial Products: same wording — considered not medically necessary for all indications.
Denied: non‑listed indications — noncoverage risk
All HAM products and indications not explicitly listed as medically necessary in this policy are not covered/not medically necessary (examples include lower‑extremity ulcers due to venous insufficiency and repair following Mohs surgery); services for non‑covered indications risk denial and potential member liability.
- "All other human amniotic membrane products and indications not listed above are not covered..."
- Examples cited: lower‑extremity ulcers due to venous insufficiency and repair following Mohs micrographic surgery.
- Provider notice: non‑covered services may not be charged to the member unless prior written agreement is obtained.
Coding linkage required to avoid denial
Claims lacking the required linkage between HCPCS codes and the policy’s listed ICD‑10 diagnoses are at risk of denial; submit the exact code pairings from the attached lists.
- "The HCPCS codes identified in the attached list are considered medically necessary when filed with the ICD10 diagnosis codes also included in the attached list."
- Policy statement that HCPCS codes not filed with the ICD‑10 codes in the attached list risk denial.
Member financial responsibility for non‑covered services
If a service is determined not medically necessary or is a non‑covered benefit, the provider may not be paid and may not bill the member unless the member has provided written agreement in advance to self‑pay.
- "If you provide services to a member which are determined to not be medically necessary... you may not charge the member for the services unless you have informed the member and they have agreed in writing in advance to continue with the treatment at their own expense."
- Providers should consult their participation agreement for applicable provisions.
Background and Scope
Human amniotic membrane (HAM) is a biologic tissue composed of the amnion and chorion that can be processed (eg, cryopreserved or dehydrated) and used as patches, grafts, or injectable formulations. HAM and amniotic fluid have been investigated across wound care, ophthalmic, and orthopedic indications. Proposed mechanisms include provision of extracellular matrix components (eg, collagen, fibronectin), growth factors, cytokines, and anti‑inflammatory proteins. Evidence strength varies by indication: several randomized controlled trials and registries support the use of specific HAM products for nonhealing diabetic lower‑extremity ulcers, selected ophthalmic conditions have supportive RCT or case series data (eg, Stevens‑Johnson syndrome, severe dry eye, corneal perforation under specific circumstances), while injectable HAM and amniotic fluid and many other indications lack sufficient evidence to conclude a net health benefit.
Definitions and Product Descriptions
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