65778_R05

Human amniotic membrane is a unique collagenous membrane derived from the innermost submucosa of the placenta.  It consists of a collagen-rich thick basement membrane and an avascular stroma.  Amniotic tissue has been used in a variety of surgical procedures to cover a defect on the surface of the eye and facilitate wound healing as well as decreasing inflammation.  Some defects are created by the surgical excision of lesions or necrotic tissue while others result from injury, infection or degeneration.  The usefulness of amniotic membrane has been attributed to its anti-inflammatory, anti-fibrotic, anti-vascularization, and anti-scarring effects and also to its ability to enhance epithelial healing.

Amnion can be prepared for implantation a number of ways.  Heat- or air-dried amniotic membrane loses some of its biologic properties and is not ideal for ocular surface rehabilitation.  The tissue can be lyophilized (freeze-dried), which induces minimal change in its properties.  Amnion can be preserved in cold glycerol and cryopreserved and stored frozen at -80 degrees.  The cryopreservation method allows for greater retention of the membrane’s structural, physiological and biochemical properties responsible for its dramatic healing and easier handling intraoperatively.

This LCD addresses limited indications of the sutureless form of amniotic membrane used as a biological corneal bandage.

Amniotic membrane transplant for ocular conditions will be considered medically reasonable and necessary for the following indications:

• Failure of standard therapy for severe ophthalmological conditions demonstrated by ocular surface cell damage or failure and/or underlying inflammation, scarring, or ulceration of the underlying stroma
• There may be circumstances where there is a severe condition requiring acute treatment with amniotic membrane such as chemical, thermal or radiation injuries, or Stevens Johnson Syndrome, or limbal stem cell failure
• Band keratopathy after treatment with other therapy such as surgery, topical medications, bandage contact lens, or patching
• Bullous keratopathy associated with an epithelial defect
• Scleral melting
• Corneal ulcer following initiation of anti-infective therapy and demonstration of clinical response for the purpose of healing the persistent epithelial defect
• Chemical burns of the ocular surface
• Conjunctival defects after treatment with other therapy such as surgery or topical medications
• Corneal melting
• Limbal Stem Cell Deficiency
• Recurrent Corneal Erosions after treatment failure with other therapy such as bandage contact lens, patching, and topical medications

LIMITATIONS:

• Amniotic membrane must be cleared by, or registered with, the U.S. Food and Drug Administration (FDA) for sutureless application of the eye
• Application for dry eye syndrome is noncovered, given no demonstrated impact on long term outcome
• Cogan’s Dystrophy is noncovered unless associated with corneal epithelial removal

Following Surgery / Within Global Period:  Use of amniotic membrane within the postoperative period of a prior surgery, not requiring a return to the operating room, and not pre-planned, is subject to the principles for global surgery defined in Medicare Claims Processing Manual, Chapter 12, §40, and will not be reimbursed separately.

Notice:  This LCD imposes diagnosis limitations that support diagnosis to procedure code automated denials. However, services performed for any given diagnosis must meet all of the indications and limitations stated in this policy, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules.