HIGHMARK COMMERCIAL MEDICAL POLICY - PENNSYLVANIA

 
 

Medical Policy:
S-249-002
Topic:
Amniotic Membrane and Amniotic Fluid
Section:
Surgery
Effective Date:
January 29, 2018
Issued Date:
October 8, 2018
Last Revision Date:
October 2018
Annual Review:
October 2018
 
 

Human amniotic membrane (HAM) forms the innermost layer of the placenta and is harvested from the time of caesarean section. It is cleaned, sterilized and cryo-preserved or dehydrated and can be utilized to facilitate wound healing in diabetic and venous ulcers or sutured onto ocular surfaces.

Amniotic fluid contains a concentration of growth factors and nutrients that promote healing in soft-tissue repair of bone, tendon and cartilage, as well as reducing inflammation and pain, in conditions such as osteoarthritis and plantar fasciitis.

Policy Position Coverage is subject to the specific terms of the member's benefit plan.

Treatment of nonhealing diabetic lower-extremity ulcers using ANY of the following HAM products may be considered medically necessary:

  • AmnioBand® Membrane; or
  • Biovance®; or
  • Epifix®; or
  • Grafix™.

Note: Nonhealing is defined as less than a 20% decrease in wound area with standard wound care for at least two (2) weeks.

All other HAM products and indications not listed above are considered experimental/investigational and, therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

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Sutured human amniotic membrane grafts may be considered medically necessary for the treatment of ANY of the following ophthalmic indications:

  • Neurotrophic keratitis; or
  • Corneal ulcers and melts; or
  • Pterygium repair; or
  • Stevens-Johnson syndrome; or
  • Persistent epithelial defects.

Note: A persistent epithelial defect is one that failed to close completely after five (5) days of conservative treatment or has failed to demonstrate a decrease in size after two (2) days of conservative treatment. Conservative treatment is defined as use of topical lubricants and/or topical antibiotics and/or therapeutic contact lens and/or patching.

Sutured human amniotic membrane grafts are considered experimental/investigational and, therefore, non-covered for the treatment of all other ophthalmic conditions because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

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Human amniotic membrane without suture (e.g., Prokera®, AmbioDisk™) for ophthalmic indications is experimental/investigational and, therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

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Injection of micronized or particulated human amniotic membrane is considered experimental/investigational and, therefore, non-covered for all indications because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Injection of human amniotic fluid is considered experimental/investigational and, therefore, non-covered for all indications because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

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Related Policies

Refer to medical policy S-33 Bio-Engineered Skin and Soft Tissue Substitutes for additional information.


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Place of Service: Inpatient/Outpatient

Experimental/Investigational (E/I) services are not covered regardless of place of service.

Amniotic membrane and amniotic fluid is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.


The policy position applies to all commercial lines of business


Denial Statements

Services that do not meet the criteria of this policy will be considered experimental/investigational (E/I). A network provider can bill the member for the experimental/investigational service. The provider must give advance written notice informing the member that the service has been deemed E/I. The member must be provided with an estimate of the cost and the member must agree in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.



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This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical or other circumstances may warrant individual consideration, based on review of applicable medical records, as well as other regulatory, contractual and/or legal requirements.

Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

Highmark retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.

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