Amniotic Membrane and Amniotic Fluid Products May be Considered Experimental, Investigational and/or Unproven

September 24, 2018

According to Blue Cross and Blue Shield of New Mexico’s medical policy number SUR704.011, Amniotic Membrane and Amniotic Fluid, all human amniotic membrane products and indications not listed below are considered experimental, investigational and/or unproven.

The use of human amniotic membrane products may be considered medically necessary for the treatment of nonhealing diabetic lower-extremity ulcers when there is medical record documentation of less than a 20% decrease in wound area with standard wound care for at least two weeks.

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

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

For all other ophthalmic conditions, sutured and unsutured human amniotic membrane grafts are considered experimental, investigational and/or unproven. Additionally, injection of human amniotic membrane and fluid is considered experimental, investigational, and unproven for all conditions, including orthopedic applications.

As a reminder, if a procedure or diagnostic service is considered experimental and/or investigational or otherwise noncovered by BCBSNM and you nevertheless wish to furnish such service and pursue payment from the member, you must inform the member (and document) prior to furnishing the services of all disclosures required for that line of business, such as for commercial and retail business that the services recommended are not covered services, that BCBSNM shall not pay or be liable for such services, and the Member shall be financially liable for such services. Absent regulatorily and contractually compliant pre-service disclosures to the member, providers may not bill the Member for experimental and/or investigational services and will instead absorb the costs thereof as a contractual adjustment. For more information regarding medical policy and experimental, investigational and/or unproven services, please see section 6.4 PDF Document of the Provider Reference Manual (PRM). For more information about billing a member for a noncovered services, please see the applicable regulation and sections 18.1.2 and 18.1.3 of the PRM PDF Document, page S36 of the Blue Cross Community CentennialSM PDF Document. section of the PRM, and section 3 of the Medicare Advantage PDF Document section of the PRM.