BlueCross BlueShield of Tennessee Medical Policy Manual

Human Amniotic Membrane Grafts and Amniotic Fluid Injections

DESCRIPTION

Several commercially available forms of human amniotic membrane (HAM) and amniotic fluid can be administered by grafts, topical application or injection. There are many products available using amnion, chorion, amniotic fluid, and umbilical cord that 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 surface disorders.

Human amniotic membrane (HAM) consists of 2 conjoined layers, the amnion and chorion, and forms the innermost lining of the amniotic sac or placenta. When prepared for use, the membrane is harvested immediately after birth, cleaned, sterilized, and either cryopreserved or dehydrated.

HAM grafts used for certain ocular surface disorders (e.g., AmnioGraft®) have been shown to be effective in promoting healing. Traditionally they have been fixated with sutures or glue or secured under a bandage contact lens. Self-contained or ringed devices (e.g. AmbioDisk™, ProKera®) with no sutures, glue, or bandage lens needed allow for application in an office setting rather than as an outpatient.

Amniotic fluid injections have been proposed as treatment for certain orthopedic uses (e.g. osteoarthritis, plantar fasciitis. When administered by injection. (e.g., AmnioMatrix®, Clarix® Flo) human amniotic tissue is micronized, or reduced in particle size to a form that can be suspended in liquid. HAM injections are being evaluated for the treatment of a variety of conditions, including tendonitis, plantar fasciitis, cartilage damage, and for alleviation of pain and stiffness in patients with osteoarthritis.

Note: This policy addresses human amniotic/chorionic membrane products and amniotic fluid products only, for other bioengineered skin and soft tissue products please refer to the Bioengineered Skin and Soft Tissue Substitutes medical policy.

POLICY

MEDICAL APPROPRIATENESS

IMPORTANT REMINDERS

ADDITIONAL INFORMATION 

Literature on human amniotic membrane injection for regenerative medicine is at a very early stage. Additional studies with larger sample sizes and longer follow-up are needed to permit conclusions. Therefore, this technology remains investigational for applications other than lower extremity diabetic skin ulcers and certain surface ocular disorders.

SOURCES 

American Academy of Ophthalmology (2013) Ophthalmic technology assessment: options and adjuvants in surgery for pterygium. Ophthalmology, 120 (1), 201-208.

BlueCross BlueShield Association. Evidence Positioning System. (3:2019) Amniotic membrane and amniotic fluid (7.01.149). Retrieved March 5, 2019 from http://www.evidencepositioningsystem.com. (91 articles and/or guidelines reviewed)

Cheng, A., Zhao, D., Chen, R., Yin, Han, Tighe, S., et. al. (2016, January) Accelerated restoration of ocular surface health in dry eye disease by self-retained cryopreserved amniotic membrane. Ocular Surface, 14(1): 5-63. (Level 4 evidence)

ECRI Institute. Product Brief. (2018, October) AmbioDisk® amniotic membrane (Katena Holdings, Inc.) for treating ophthalmic wounds and ocular defects. Retrieved March 5, 2019 from ECRI Institute. (4 articles and/or guidelines reviewed)

Farr, J. and Cohen, S. (2016, June) Subchondroplasty® as an emerging treatment option for sports-related subchondiral stress fractures. ASPETAR: Sports Medicine Journal. Vol. 5, page 284-291. (Level 4 evidence)

Frykberg, R., Gibbons, G., Walters, J., Wukich, D., and Milstein, F. (2016) A prospective, multicentre, open-label, single-arm clinical trial for treatment of chronic complex diabetic foot wounds with exposed tendon and/or bone: positive clinical outcomes of viable cryopreserved human placental membrane. International Wound Journal ISSN 1742-4801. (Level 2 evidence)

Gheorghe, A., Pop, M., Burcea, M., and Serban, M. (2015, December) New clinical application of amniotic membrane transplant for ocular surface disease. Journal of Medicine and Life, Vol. 9, Issue 2, 177-179. (Level 5 evidence)

Hanselman, A., Tidwell, J., Santrock, R., (2015) Cryopreserved Human Amniotic Membrane Injection for Plantar Fasciitis: A Randomized, Controlled, Double-Blind Pilot Study. Foot & Ankle International, 36 (2), 15-158. (Level 2 evidence)

Hirche, C., Senghaas, A., Fischer, S., Hollenbeck, S., Kremer, T., and Kneser, U. (2016, February) Novel use of a flowable collagen-glycosaminoglycan matrix (Integra™ Flowable Wound Matrix) combined with percutaneous cannula scar tissue release in treatment of postburn malfunction of the hand--A preliminary 6 month follow-up. Burns, 42 (1, 1-7. Abstract retrieved March 15, 2018 from PubMed database.

Infectious Diseases Society of America (2012. June) 2012 clinical practice guideline for the diagnosis and treatment of diabetic foot infections. Retrieved January 27, 2014 from http://www.guidelines.gov.

International Dry Eye Workshop (2007) The definition and classification of dry eye disease: report of the definition and classification subcommittee. The Ocular Surface, 5 (2), 75-92.

Johnson, E., Marshall, J., and Michael, G. (2016) A comparative outcomes analysis evaluating clinical effectiveness in two different human placental membrane products for wound management. Wound Repair and Regeneration, e-published DOI:10.1111/wrr.12503. (Level 3 evidence)

Lavery, L., Fulmer, J., Shebetka, K., Regulski, M., Vayser, D., Fried, D, et. al., (2014) The efficacy and safety of Grafix® for the treatment of chronic diabetic foot ulcers: results of a multi-centre, controlled, randomised, blinded, clinical trial. International Wound Journal ISSN 1742-4801. (Level 2 evidence - Industry sponsored)

Liu, J., Li, l. and Li, X. (2019, January) Effectiveness of cryopreserved amniotic membrane transplantation in corneal ulceration: a meta-analysis. Cornea, [e-published ahead of print] doi: 10.1097/ICO. Abstract retrieved March 5, 2019 from PubMed database.

McGaughy, A., Gupta, P., Fekrat, S., and Scott, I. (2015, February) In office use of amniotic membrane. Eyenet. 31-32. (Level 5 evidence)

Murphy, S., Atala, A. (2013) Amniotic Fluid and Placental Membranes; Unexpected Sources of Highly Multipotent Cells. Seminars in Reproductive Medicine. 2013; 31 (1), 62-68. (Level 2 evidence)

National Institute for Health and Clinical Excellence (NICE). (2016, January). Diabetic foot problems: prevention and management. Retrieved April 4, 2018 from http://www.nice.org.uk.

Serena, T., Carter, M., Lam, T., Sabo, M., & DiMarco, D., (September, 2014) A multicenter, randomized, controlled clinical trial evaluating the use of dehydrated human amnion/chorion membrane allografts and multilayer compression therapy vs. multilayer compression therapy alone in the treatment of venous leg ulcers. Wound Repair and Regeneration.22 688-692. (Level 2 evidence - Industry sponsored)

Sheikh, E. S., Sheikh, E. S., & Fetterolf, D. E. (2013). Use of dehydrated human amniotic membrane allografts to promote healing in patients with refractory non healing wounds. International Wound Journal, 1-7. (Level 4 evidence)

Smiell, J., Treadwell, T., Hahn, H., and Hermans, M. (2015, June) Real-world experience with a decellularized dehydrated human amniotic membrane allograft. Wounds, 27 (6), 158-69. Abstract retrieved April 4, 2018 from PubMed database.

Suri, K., Kosker, M., Raber, I., Hammersmith, K., Nagra, P., Ayres, B., et al. (2013, September) Sutureless amniotic membrane ProKera® for ocular surface disorders: short-term results. Eye Contact Lens, 39(5):341-7. Abstract retrieved May 22, 2017 from PubMed database.

Tear Film and Ocular Surface Society (2017, May) TFOS DEWS II management and therapy report. Retrieved March 6, 2019 from www.theocularsurface.com. 

U. S. Food and Drug Administration. (2003, December) Center for Devices and Radiologic Health. 510(k) Premarket Notification Database. K032104 (ProKera™). Retrieved May 23, 2017 from http://www.fda.gov.

Vines, J. B., Aliprantis, A. O., Gomoll, A. H., & Farr, J. (2015). Cryopreserved amniotic suspension for the treatment of knee osteoarthritis. Journal of Knee Surgery, 2015, Dec 18, [E-pub ahead of print]. Abstract retrieved June 28, 2016 from PubMed database.

Winifred S. Hayes, Inc. Medical Technology Directory (2015, April last update search April 2018) Amniotic membrane transplantation (AMT) for corneal reconstruction. Retrieved March 5, 2019 from www.Hayesinc.com. (41 articles and/or guidelines reviewed)

Winifred S. Hayes, Inc. Medical Technology Directory (2015, March last update search March 2018) Amniotic membrane transplantation (AMT) for conjunctival reconstruction and glaucoma surgery. Retrieved March 5, 2019 from www.Hayesinc.com. (60 articles and/or guidelines reviewed)

Zelen, C. M., Gould, L., Serena, T., Carter, M., Keller, J. & Li, W. (2014) A prospective, randomised, controlled, multi-centre comparative effectiveness study of healing using dehydrated human amnion/chorion membrane allograft, bioengineered skin substitute or standard of care for treatment of chronic lower extremity diabetic ulcers. International Wound Journal. ISSN 1742-4801. (Level 2 evidence - Industry sponsored)

Zelen, C., Poka, A., Andrews, J. (2013) Prospective, randomized, blinded, comparative study of injectable micronized dehydrated amniotic/chorionic membrane allograft for plantar fasciitis - a feasibility study. Foot & Ankle International, 34 (10), 1332-1339. (Level 2 evidence)

ORIGINAL EFFECTIVE DATE: 12/12/2015

MOST RECENT REVIEW DATE:  6/30/2019

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