This policy version was replaced August 1, 2022. To find the newest version, go to https://www.bluecrossmn.com/providers/medical-policy-and-utilization-management, read and accept the Blue Cross Medical Policy Statement, then select “Blue Cross and Blue Shield of Minnesota Medical Policies.” This will bring up the Medical Policy search screen. Enter the policy number without the version number (last 3 digits).
Human amniotic membrane consists of 2 conjoined layers, the amnion and chorion, and forms the innermost lining of the amniotic sac or placenta. When prepared for use as an allograft, the membrane is harvested immediately after birth, cleaned, sterilized, and either cryopreserved or dehydrated. Many products available using amnion, chorion, amniotic fluid, and umbilical cord are being studied for the treatment of a variety of conditions, including chronic full-thickness diabetic lower-extremity ulcers, venous ulcers, knee osteoarthritis, plantar fasciitis, and ophthalmic conditions. The products are formulated either as patches, which can be applied as wound covers, or as suspensions or particulates, or connective tissue extractions, which can be injected or applied topically.
Amniotic fluid surrounds the fetus during pregnancy and provides protection and nourishment. In the second half of gestation, most of the fluid is a result of micturition and secretion from the respiratory tract and gastrointestinal tract of the fetus, along with urea. The fluid contains proteins, carbohydrates, peptides, fats, amino acids, enzymes, hormones, pigments, and fetal cells. Amniotic fluid has been compared with synovial fluid, containing hyaluronan, cholesterol, and cytokines. Injection of amniotic fluid or amniotic fluid?derived cells is currently being evaluated for the treatment of osteoarthritis and plantar fasciitis.
The U.S. Food and Drug Administration (FDA) regulates human cells and tissues intended for implantation, transplantation, or infusion through the Center for Biologics Evaluation and Research, under Code of Federal Regulation (CFR) title 21, parts 1270 and 1271. Human amniotic membrane products and amniotic fluid products are included in these regulations. In 2003, ProKera™ was cleared for marketing by FDA through the 510(k) process for the ophthalmic conformer that incorporates amniotic membrane (K032104). FDA determined that this device was substantially equivalent to the Symblepharon Ring, a device used to keep ocular fornices formed after surgery related to disease or trauma. The ProKera™ device is intended “for use in eyes in which the ocular surface cells have been damaged, or underlying stroma is inflamed and scarred.”
Note: Please see policy IV-137, Bioengineered Skin and Soft Tissue Substitutes, for products unrelated to amniotic membrane and amniotic fluid.
I. Human Amniotic Membrane Grafts for Ophthalmic Conditions
II. Human Amniotic Membrane Grafts for Non-Ophthalmic Conditions
III. Experimental/Investigative Human Amniotic Membrane
All other human amniotic membrane products are considered EXPERIMENTAL/INVESTIGATIVE for all conditions due to a lack of clinical evidence demonstrating an impact on improved health outcomes.
IV. Micronized or Particulated Human Amniotic Membrane
Micronized or particulated human amniotic membrane products are considered EXPERIMENTAL/ INVESTIGATIVE for all conditions due to a lack of clinical evidence demonstrating an impact on improved health outcomes.
V. Injection of Amniotic Fluid
Injection of amniotic fluid is considered EXPERIMENTAL/ INVESTIGATIVE for all conditions due to a lack of clinical evidence demonstrating an impact on improved health outcomes.
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No additional statements.
Blue Cross and Blue Shield of Minnesota medical policies apply generally to all Blue Cross and Blue Plus plans and products. Benefit plans vary in coverage and some plans may not provide coverage for certain services addressed in the medical policies. When determining coverage, reference the member’s specific benefit plan, including exclusions and limitations.
Medicaid products may provide different coverage for certain services, which may be addressed in different policies. For Minnesota Health Care Program (MHCP) policies, please consult the MHCP Provider Manual website.
Medicare products may provide different coverage for certain services, which may be addressed in different policies. For Medicare National Coverage Determinations (NCD), Local Coverage Determinations (LCD), and/or Local Coverage Articles, please consult CMS, National Government Services, or CGS websites.
Note that services with specific coverage criteria may be reviewed retrospectively to determine if criteria are being met. Retrospective denial of claims may result if criteria are not met.
Blue Cross and Blue Shield of Minnesota reserves the right to revise, update and/or add to its medical policies at any time without notice. Codes listed on this policy are included for informational purposes only and are subject to change without notice. Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement.
These guidelines are the proprietary information of Blue Cross and Blue Shield of Minnesota. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.
Acknowledgements:
CPT® codes copyright American Medical Association® 2022. All rights reserved.
CDT codes copyright American Dental Association® 2022. All rights reserved.
