Amniotic Membrane and Amniotic Fluid
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Defines medical coverage and medical necessity determinations for human amniotic membrane (HAM) grafts, HAM products (patch/flowable/injectable), and amniotic fluid products for wound care and selected ophthalmic and orthopedic indications for Blue Cross Blue Shield - Rhode Island members.
No material clinical or coverage changes in this revision.
Coverage determinations and clinical indications
Coverage determinations and evidence summaries
Coverage determinations vary by product form, indication, and payer product (Medicare Advantage vs Commercial).
Filed with a covered diagnosis
Filed with a covered diagnosis
Medicare Advantage and Commercial products specify noncoverage/not medically necessary
Corroboration with well-designed RCTs needed
Injection therapies considered not covered/not medically necessary
RCTs unlikely due to rarity; evidence considered sufficient
Context-specific determinations apply
Indications with sufficient evidence
Covered when evidence demonstrates net health benefit for specific ocular conditions:
Large RCTs unlikely due to rarity/severity of disease
Temporizing coverage
Covered as a temporizing measure when standard therapy is not immediately available:
Standard treatment remains corneal transplantation
Indications with insufficient or mixed evidence (not established)
Not covered / Not supported as medically necessary due to insufficient or negative evidence:
Documentation of insufficient healthy tissue may be required before HAM considered
Dry eye (sufficient evidence)
Covered when evidence demonstrates benefit for symptomatic severe dry eye unresponsive to conservative therapy:
Duration of benefit reported up to 3 months
All human amniotic membrane (HAM) products and indications that are not explicitly listed as medically necessary in this policy are considered 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 reconstructive repair following Mohs micrographic surgery. For Medicare Advantage plans the policy states these HAM grafts are not covered when not outlined as medically necessary, and for Commercial products they are considered not medically necessary under the same circumstances.
For pterygium repair, a conjunctival or limbal autograft is preferred when there is sufficient healthy tissue to create an autograft. Systematic reviews of randomized trials found autograft to be more effective than HAM graft in reducing pterygium recurrence; therefore HAM should only be considered when documentation demonstrates insufficient healthy tissue for autograft.
Injection therapies using micronized or particulated human amniotic membrane and injections of human amniotic fluid are not covered / not medically necessary for all indications (including, but not limited to, osteoarthritis and plantar fasciitis) because current evidence is insufficient to demonstrate an improvement in net health outcome.
A randomized controlled trial comparing sutured HAM to stromal puncture for palliative treatment of pain from bullous keratopathy found no advantage for sutured HAM. Based on this RCT, the evidence does not support routine use of sutured HAM over the simpler stromal puncture procedure for pain management in patients who are not candidates for keratoplasty.
Randomized controlled trials of HAM as adjunctive therapy for moderate or severe acute ocular chemical burns have produced mixed results. Across three RCTs (197 patients), two did not show faster epithelial healing and there was no significant benefit for other outcomes; therefore the evidence is insufficient / not established to support HAM as adjunctive therapy for these burns.
Codes and billing requirements
| HCPCS codes (see attached list) | HCPCS codes identified in the attached list are considered medically necessary when filed with the included ICD-10 diagnosis codes. |
Provider responsibilities, prior authorization, and billing guidance
Verify benefits and prior authorization per member contract
Prior authorization is not specified in this policy document. Verify member-specific prior authorization requirements and benefits, as coverage varies by contract and the Benefit Booklet or Evidence of Coverage supersedes this policy.
- Prior authorization is listed as “Not applicable” in this medical policy excerpt, but payer rules may differ by member contract.
- Confirm prior authorization and benefit requirements using the member’s Benefit Booklet, Evidence of Coverage, or provider call center before scheduling services.
File HCPCS codes with required ICD‑10 diagnoses
When billing, file the HCPCS codes identified in the policy’s attached list only with the ICD‑10 diagnosis codes included in the attached list; prior authorization may be required per payer rules.
- HCPCS codes are considered medically necessary only when paired with the listed ICD‑10 codes.
- Prior authorization requirements may still apply per payer or member contract.
Confirm prior authorization with payer for each member
This document does not specify a universal prior authorization requirement; providers must verify any member-specific prior authorization rules with the payer or via the provider call center.
- Policy lists "Not applicable" for prior authorization but advises verification of member-specific requirements.
- Contact the payer/provider call center or review subscriber documents for authorization rules.
Check Benefit Booklet / Evidence of Coverage for member-specific limits
Benefits and coverage vary by group and contract; refer to the member’s Benefit Booklet, Evidence of Coverage, or Subscriber Agreement for applicable surgery coverage and limitations.
- Benefit Booklet / Evidence of Coverage / Subscriber Agreement take precedence over this policy.
- Verify member-specific surgical coverage and limitations before treatment.
Prefer autograft for pterygium repair; document rationale if using HAM
For pterygium repair, conjunctival or limbal autograft is preferred over HAM when sufficient healthy tissue exists; if HAM is used, document why autograft was not feasible.
- Systematic reviews found autograft more effective than HAM in reducing recurrence.
- Document lack of sufficient healthy conjunctival tissue to justify use of HAM.
Provider action — see policy for verification and documentation requirements
(No specific provider action text provided in source for this placeholder. Review member contract and policy details as noted elsewhere in this document.)
- If applicable, follow the verification and documentation steps described throughout this policy.
File claims with a covered ICD‑10 diagnosis
Treatments must be filed with a covered diagnosis listed in this policy to be considered medically necessary (for example, nonhealing diabetic lower‑extremity ulcers and listed ophthalmic indications).
- File the procedure with one of the covered ICD‑10 diagnoses specified in the policy’s attached list.
- Services filed without a covered diagnosis may be considered not medically necessary.
Pair HCPCS codes with the listed ICD‑10 codes
When submitting claims, bill the HCPCS codes identified as medically necessary only with the ICD‑10 diagnosis codes listed in the policy’s attached list; failure to pair codes as specified may lead to denial.
- HCPCS codes are considered medically necessary when paired with the ICD‑10 codes included in the attached list.
- Ensure coding matches the HCPCS–ICD‑10 pairings provided by the policy.
Verify member benefits and eligibility via provider call center
For member-specific benefits and eligibility, call the provider call center and verify the member’s subscriber agreement or employer agreement, which supersede this medical policy.
- Provider call center is the source for member‑specific benefit information.
- Subscriber or employer agreement documents override policy provisions.
Do not use injectable HAM or amniotic fluid — not covered
Injection of micronized or particulated human amniotic membrane and injection of human amniotic fluid are considered not covered/not medically necessary for all indications (including but not limited to osteoarthritis and plantar fasciitis).
- Do not bill or provide injectable HAM or amniotic fluid for indications listed as not covered.
- These injection therapies are explicitly stated as not covered/not medically necessary.
Other HAM products/indications not listed as medically necessary are not covered
All other human amniotic membrane products and indications not listed as medically necessary in this policy are not covered or are considered not medically necessary; confirm coverage before providing treatment.
- Treatments and products not explicitly listed as medically necessary in this policy are considered not covered or not medically necessary.
- Verify coverage and obtain member consent if pursuing non‑covered services.
Risk of denial if HCPCS codes not paired with listed ICD‑10 codes
Claims for HCPCS codes that are not paired with one of the ICD‑10 diagnosis codes from the policy’s attached list risk denial.
- Ensure each billed HCPCS code is accompanied by an ICD‑10 diagnosis code from the policy’s list.
- Unpaired or incorrectly paired codes may be denied.
Do not bill member for non‑covered/not medically necessary services without written consent
If services are determined to be not medically necessary or non‑covered benefits, you may not charge the member unless the member was informed in advance and agreed in writing to continue the treatment at their own expense.
- Obtain written member agreement in advance before charging the member for non‑covered or not medically necessary services.
- Refer to your participation agreement for applicable provisions.
Background and scope
Human amniotic membrane (HAM) and amniotic fluid are biologic products derived from placental tissues. HAM (amnion and chorion) is available as cryopreserved or dehydrated grafts, patches, or flowable/particulate formulations and contains extracellular matrix proteins, growth factors, cytokines, and anti‑inflammatory proteins that are considered largely nonimmunogenic. Amniotic fluid is a fetal‑derived fluid containing proteins, peptides, and hyaluronan and has been investigated as an injectable biologic. This policy defines coverage for HAM grafts, HAM product forms (patch/flowable/injectable), and amniotic fluid products across wound‑healing, ophthalmic, and selected orthopedic indications, and notes that many product forms and indications are not covered or are considered not medically necessary when evidence is insufficient.
Key definitions
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