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 are being investigated for ophthalmic use.

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.

POLICY

See also:  Bio-Engineered Skin and Soft Tissue Substitutes

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 

BlueCross BlueShield Association. Medical Policy Reference Manual. (5:2017) Amniotic membrane and amniotic fluid injections (7.01.149). Retrieved May 30, 2017 from BlueWeb. (26 articles and/or guidelines reviewed)

BlueCross BlueShield Association. Medical Policy Reference Manual. (1:2017). Bio-engineered skin and soft tissue substitutes (7.01.113). Retrieved May 19, 2017 from BlueWeb. (62 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): 56-63. (Level 4 evidence)

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)

First Coast Service Options, Inc. (2016, October) Local coverage determination (LCD): Amniotic membrane- sutureless placement on the ocular surface (L36237). Retrieved May 19, 2017 from https://www.cms.gov.

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)

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.

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)

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). (2015, August). Diabetic foot problems: prevention and management. Retrieved May 22, 2017 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)

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.

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 2017) Amniotic membrane transplantation (AMT) for corneal reconstruction. Retrieved May 22, 2017 from www.Hayesinc.com (38 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. M., Serena, T., Denoziere, G., & Fetterolf, D. (2013, October). A prospective randomised comparative parallel study of amniotic membrane wound graft in the management of diabetic foot ulcers. International Wound Journal, 10 (5), 502-507. (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:  11/1/2017

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