65778_R37

This Medicare carrier does not have a local coverage determination (LCD) for the placement of an amniotic membrane on the ocular surface; without sutures.  The policy presented is to serve as a sample and is provided as a reference guide only and should not be construed as policy for your current Medicare carrier.

All coverage criteria should be clearly documented in the patient’s medical record and made available to Medicare upon request.

The patient’s medical record should contain documentation that fully supports the medical necessity for amniotic membrane placement as covered by Medicare.  This documentation includes, but is not limited to, relevant medical history, physical examination and results of pertinent diagnostic tests or procedures.

Report an amniotic membrane placement using CPT code 65778.

ProKera is a Class II medical device comprised of a cryopreserved amniotic membrane graft fastened to a thermoplastic ring-set.  The cell activity in the tissue has been inactivated to eliminate the possibility of graft rejection while retaining the natural biologic properties.

• ProKera is intended for use in eyes in which ocular surface cells have been damaged, or underlying stroma is inflamed or scarred.  Acting as a self retaining biological bandage, ProKera effectively treats superficial corneal surface diseases by reducing pain, suppressing inflammation, promoting epithelial healing, and avoiding haze.
• ProKera is inserted between the eyeball and the eyelid to maintain space in the orbital cavity and to prevent closure or adhesions.  Insertion of the conformer also enables application of the amniotic membrane to the ocular surface without the need for sutures.
• ProKera is for single and prescription use only

Medicare covers the placement of an amniotic membrane when medically necessary.  However, they do not cover the cost of the supply of ProKera separately.  HCPCS code V2790, amniotic membrane for surgical reconstruction per procedure, is no longer eligible for discrete Medicare payment in any setting.  Reimbursement for the supply is included with payment for the procedure.

This Medicare carrier has no utilization guidelines for amniotic membrane placement.  It is expected that these services would be performed as indicated by current medical literature and/or current standards of optometric/ophthalmic practice.

In the absence of specific utilization guidelines, eye doctors should adhere to CMS Ruling 95-1 (V) which states that utilization of these services should be consistent with locally acceptable standards of optometric/ophthalmic practice.