Amniotic Membrane and Amniotic Fluid
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Defines medical necessity and coverage stance for human amniotic membrane (HAM) and amniotic fluid products (patches, flowable, injectable) for various indications including diabetic lower-extremity ulcers, ophthalmic conditions, osteoarthritis, plantar fasciitis, and venous ulcers for Blue Cross Blue Shield - Rhode Island members.
No material clinical or coverage changes in this revision.
Coverage Criteria and Medical Necessity
inv-01: Indications considered medically necessary / covered
Covered when ALL of the following are met for specified indications:
Supported by RCTs and registries; file with covered diagnosis
Policy lists these indications as medically necessary for grafts
Listed separately when suture or glue is used
Evidence sufficient despite rarity of condition
inv-02: Not medically necessary / not covered
Not covered or considered not medically necessary when any of the following apply
Explicit policy exclusion for injectable formulations
Evidence insufficient per policy
Policy-wide exclusion
Policy identifies these ocular situations as having insufficient evidence
inv-03: Indication-specific coverage determinations
Coverage determinations by indication based on evidence sufficiency:
chunk 21: RCT support
chunk 23: RCT + series
chunk 25: temporizing benefit
chunk 24: mixed RCT results
chunk 26: systematic review findings
chunk 27: retrospective study
chunk 18: no comparative data
chunk 19: RCT negative for advantage
chunk 20: limited evidence
chunk 22: limited evidence
Injection formulations of human amniotic membrane (micronized or particulated HAM) and injections of human amniotic fluid are explicitly not covered / not medically necessary for all indications. This includes, but is not limited to, use as injectable therapies for osteoarthritis and plantar fasciitis. Claims for these injectable products should be denied or considered not medically necessary when submitted for indications outside the policy's listed medically necessary uses.
This noncoverage statement applies across plan types in the policy language: for Medicare Advantage the policy states these injection formulations are “not covered,” and for Commercial products they are described as “not medically necessary.”
Human amniotic membrane products and clinical uses that are not specifically listed as medically necessary in the policy are considered not covered / not medically necessary. Examples called out in the policy include treatment of lower-extremity ulcers due to venous insufficiency and repair following Mohs micrographic surgery.
In practical terms, when a HAM product or an indication is not among the ophthalmic or diabetic lower-extremity ulcer indications the policy lists as medically necessary, the policy directs that the use be treated as not covered because current evidence is insufficient to demonstrate an improvement in net health outcome.
For pterygium repair, the policy notes that when there is sufficient healthy conjunctiva available, a conjunctival or limbal autograft is preferred. Systematic reviews of randomized trials found autograft to be more effective than HAM grafting in reducing recurrence, and therefore HAM is not favored when autograft is an option.
When conjunctival/limbal autograft cannot be performed because of insufficient healthy tissue, HAM has been studied; however, the policy concludes the evidence is insufficient to establish that HAM improves net health outcome for pterygium repair.
The policy reiterates that injectable formulations—specifically micronized/particulate HAM and amniotic fluid injections—are considered not medically necessary / not covered across indications. Providers submitting claims for repeat or alternative placement of AM products should note this explicit exclusion for injection forms.
For non-injectable HAM products used in indications not listed as medically necessary, the policy similarly treats those uses as not covered. In other words, both repeated placement of nonlisted HAM products and any injectable AM formulations fall under the policy’s noncoverage stance.
For several complex or uncommon ophthalmic and reconstructive indications, the policy finds the evidence inconclusive or insufficient to support coverage. Examples where benefit is judged inconclusive include moderate or severe acute ocular chemical burns (three RCTs, total N=197, with mixed results), corneal perforation with active inflammation after corneal transplant (no comparative evidence identified), bullous keratopathy in patients not candidates for curative treatment (an RCT showed no advantage), partial limbal stem cell deficiency (no comparative trials), and persistent epithelial defects or ulceration refractory to conservative therapy (no comparative trials).
The policy also highlights limited or observational evidence for pterygium repair when autograft is possible and for repair after Mohs micrographic surgery (a retrospective comparative study showed some favorable outcomes for placental allograft but was limited by its observational design). For these indications, the policy concludes the evidence is insufficient to determine an improvement in net health outcome and therefore does not establish coverage.
Coding and Definitions
| HCPCS codes (attached list) | HCPCS codes identified in the attached list considered medically necessary when filed with the attached ICD-10 diagnosis codes |
Provider Actions, Billing and Prior Authorization
Prior authorization / benefits may vary by contract
Prior authorization is not required by this policy; however, benefits and coverage may vary by contract — providers must refer to the member’s Benefit Booklet, Evidence of Coverage, or Subscriber Agreement for plan-specific prior authorization/adjudication rules.
HCPCS codes medically necessary only with listed ICD-10 diagnoses
The policy states that the HCPCS procedure codes in the attached list are considered medically necessary only when filed with the ICD-10 diagnosis codes included in the attached list; filing HCPCS codes without the listed ICD-10 codes may not meet medical necessity.
Step therapy context — standard wound care precedes HAM in trials
Randomized trials of HAM for nonhealing diabetic lower‑extremity ulcers compared HAM products with standard wound care or established advanced wound care products; the trials defined nonhealing as <20% healing after ≥2 weeks of standard care, implying standard wound care should precede consideration of HAM.
- Nonhealing definition used in trials: <20% healing with ≥2 weeks of standard care.
Confirm product form and indication against policy lists before treatment
Review the policy’s covered-indication lists and exclusions before submission; ensure the selected HAM product and formulation match a medically necessary indication in the policy and that injectable micronized/particulate formulations or amniotic fluid injections are not being billed for covered uses unless explicitly listed.
Claims must be filed with a covered diagnosis and plan-specific benefit verification
Claims for covered uses must be filed with a covered diagnosis code and supporting documentation; benefits may vary by contract so providers should check the member’s Benefit Booklet, Evidence of Coverage, or Subscriber Agreement when submitting claims for nonhealing diabetic lower‑extremity ulcers or listed ophthalmic indications.
- File claims with a covered ICD‑10 diagnosis from the policy’s attached list.
- Verify member-specific benefits/prior authorization rules in the Benefit Booklet/Evidence of Coverage.
File listed HCPCS with the corresponding ICD‑10 codes
When billing for covered HAM services, file the specific HCPCS codes identified in the policy’s attached list together with the corresponding ICD‑10 diagnosis codes from the attached list to meet the policy’s medical‑necessity linkage.
- HCPCS codes in the attached list → must be paired with ICD‑10 codes in the attached list.
Denial risk — injectable/particulate formulations and amniotic fluid injections
Claims for injectable micronized/particulate HAM formulations or injections of amniotic fluid are not covered/not medically necessary for all indications (including knee osteoarthritis and plantar fasciitis); submitting these formulations or non‑listed indications may be grounds for denial.
- Injection of micronized/particulate HAM and injection of amniotic fluid are explicitly not covered/not medically necessary for all indications.
- Common non‑covered examples called out include osteoarthritis and plantar fasciitis.
Coding linkage required: pair HCPCS with included ICD‑10 diagnoses and documentation
HCPCS procedure codes are considered medically necessary only when submitted with the ICD‑10 diagnosis codes listed in the policy’s attached diagnosis list; failure to pair the HCPCS code with an included ICD‑10 code and corresponding documentation may result in denial for lack of medical necessity.
- Ensure documentation supports the ICD‑10 diagnosis claimed and links to the HCPCS billed.
- Mismatched or absent diagnosis codes from the attached list may lead to claim denial.
Background and Clinical Context
Human amniotic membrane (HAM) and amniotic fluid products are derived from the placenta and surrounding fetal fluid and are processed as allografts. HAM consists of the amnion and chorion, and when prepared for clinical use it is harvested after birth, cleaned, sterilized, and either cryopreserved or dehydrated for application as patches, flowable preparations, or particulates.
Amniotic fluid is the fluid surrounding the fetus and contains proteins, peptides, hyaluronan, and cells; both HAM and amniotic fluid are biologically active and have been investigated for wound healing, ocular surface reconstruction, and injectable orthopaedic applications, but clinical evidence varies by indication and product form.
Definitions
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