CPT Code: 65778  Region:  05

Covered states:  Florida, Puerto Rico, Virgin Islands

Title:  Placement of Amniotic Membrane on the Ocular Surface; Without Sutures.

Category
Minor Surgical Procedure

Description
Amniotic membrane is the innermost layer of the placenta consisting of a thick basement membrane and an avascular stromal matrix.



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.

ICD-10 Diagnosis Codes

ICD-10 CodesDescription
H04.131 - H04.139 Lacrimal cyst, right lacrimal gland - Lacrimal cyst, unspecified lacrimal gland
H15.89 - H15.9 Other disorders of sclera - Unspecified disorder of sclera
H16.001 - H16.079 Unspecified corneal ulcer, right eye - Perforated corneal ulcer, unspecified eye
H16.121 - H16.129 Filamentary keratitis
H16.231 - H16.239 Neurotrophic keratoconjunctivitis
H18.10 - H18.13 Bullous keratopathy, unspecified eye - Bullous keratopathy, bilateral
H18.421 - H18.429 Band keratopathy, right eye - Band keratopathy, unspecified eye
H18.831 - H18.839 Recurrent erosion of cornea, right eye - Recurrent erosion of cornea, unspecified eye
H18.891 - H18.899 Other specified disorders of cornea, right eye - Other specified disorders of cornea, unspecified eye
L51.0 Nonbullous erythema multiforme
L51.1 Stevens-Johnson syndrome
L51.3 Stevens-Johnson syndrome-toxic epidermal necrolysis overlap syndrome
L51.9 Erythema multiforme, unspecified
T26.00XA - T26.92XS Burn of unspecified eyelid and periocular area, initial encounter - Corrosion of left eye and adnexa, part unspecified, sequela


Medical record documentation (e.g., office/progress notes, history and physical, procedure notes) must indicate the medical necessity for performing this service.  When the documentation does not meet the criteria for the service rendered or the documentation does not establish the medical necessity for the services, such services will be denied as not reasonable and necessary.

The procedure indicated in this LCD will be considered medically reasonable and necessary only when furnished by a qualified optometrist or ophthalmologist.

Do not report 65778 in conjunction with 65430, 65435, 65780.

For placement of amniotic membrane using tissue glue alone, use 66999.

HCPCS code V2790 (amniotic membrane for surgical reconstruction, per procedure) is included in the allowance for CPT code 65778.  Therefore, V2790 should not be billed separately when this code is billed.

It is expected that these services would be performed as indicated by current medical literature and/or standards of practice.  When services are performed in excess of established parameters, they may be subject to review for medical necessity.

One placement per eye is expected in an episode of care.  More than one will be subject to prepayment review and possible denial.