Appeal type: Experimental/Investigational
Decision: Overturned

Nature of Statutory Criteria/ Case Summary:  The enrollee requested reimbursement for placement of an amniotic membrane graft on the right cornea for a history of penetrating keratoplasty graft in the right eye that developed a corneal ulceration. He also requested authorization and coverage for future placement of a second amniotic membrane graft on the right cornea, if necessary. His ophthalmologist recommended a self-retained amniotic graft when his epithelial recovery appeared stalled. He underwent a right central cornea amniotic membrane transplant. This amniotic membrane was used to promote healing of a non-healing central corneal ulcer; non-infectious. The operative note indicated he had not responded to conservative medical management and typical treatment. During a follow up visit, the epithelium was noted to be substantially improved but not yet closed. A bandage contact lens was placed. Documentation noted a second amniotic graft may be necessary.  Upon removal of the contact lens, no infiltrate and no epithelial defect were noted.  According to the literature, human amniotic membrane (AM) is effective for corneal epithelium healing, and is routinely used as a component of ocular surface reconstruction, such as corneal ulcer. Literature supports the use of AM over other corneal material because of its special biological properties that prevent transplant rejection. AM is an effective material that can easily restore integration of the ocular epithelium (i.e. healing) and prevent corneal perforation and permanent, irreversible vision loss. According to a current study on the effectiveness of AM transplant on corneal ulcer, the use of AM transplant is equally effective on infective corneal ulcers as it is on non-infective corneal ulcer in enhancing the corneal epithelium healing rate. In this case, the enrollee had developed a corneal ulcer on his right eye with penetrating keratoplasty graft. The enrollees ophthalmologist considered his corneal ulcer was refractory to conservative medical management, and needed an amniotic membrane graft implantation for faster healing of the corneal epithelium. To date, literature supports early diagnosis and treatment for corneal ulcers because of its ability to threaten a enrollees vision by leading to permanent corneal opacity or persistent epithelial defects. Considering the safety and effectiveness of amniotic membrane graft and the severity of enrollees corneal ulcer (that is refractory to conservative management), the literature supports the use of amniotic membrane graft implantation used for this enrollee to expedite corneal epithelium healing and prevent irreversible vision loss. Since the patient had a corneal transplant in the right eye, it is crucial to preserve the corneal epithelial surface.  An amniotic graft would likely be more beneficial for this patient than standard treatment if a second graft becomes necessary. Amniotic membrane grafting would aid in re-epithelization of the cornea and promote healing. Final Result: Three of the three reviewers determined that the requested services are likely to be more beneficial than any available standard therapy for treatment of the enrollees medical condition. Credentials/Qualifications: Three reviewers are board certified in ophthalmology and are actively practicing.  All three reviewers are experts in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.