Reimbursement for PROKERA following Corneal Collagen Cross-Linking (Bio-Tissue)



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Q  What is PROKERA®?

A  PROKERA is a corneal-epithelial therapeutic device consisting of an ophthalmic conformer that incorporates one or two layers of cryopreserved amniotic membrane and serves as a biologic corneal bandage. It is inserted between the eyeball and the eyelid and is self-retained on the eye – no suture and no tissue glue. The CryoTek® processed tissue retains the key biologic components of the amniotic membrane that are anti-inflammatory, anti-scarring, and anti-angiogenic. It also promotes limbal stem-cell proliferation and accelerates wound healing. The FDA clearance notes that it may remain in place up to 29 days. In most uses of PROKERA, natural dissolution of the membrane occurs in about 5-10 days, at which point the conformer can be removed. It may be removed earlier if the patient’s condition improves.

The PROKERA family of products includes PROKERA, PROKERA Slim, PROKERA Plus, and PROKERA Clear.


Q  Are there medically necessary uses of PROKERA following corneal collagen cross-linking (CXL)?

A  Yes. In cases of persistent corneal epithelial defects, or delayed healing, following epi-off CXL, PROKERA can aid the healing process when reepithelization isn’t satisfactory in 4-5 days. Adverse events are infrequent (1-2%); most patients have no surgical complications after CXL.


Q  What CPT code should I use to report placement of PROKERA?

A  CPT 65778 (Placement of amniotic membrane on the ocular surface; without sutures) describes this procedure.


Q  Is treatment of persistent corneal epithelial defects after CXL covered by insurance?

A  Probably. The treatment of surgical complications such as infection, inflammation and poor wound healing, are typically covered by insurance even if the primary procedure was not covered. Chart documentation is expected to provide a medical rationale for PROKERA based on failure of regular treatment (i.e., bandage contact lens). Routine postoperative care is included in the global surgery package of the primary procedure and not separately reimbursed.


Q  Is there a postoperative period for CXL?

A  Not for Medicare. Within the Medicare Physician Fee Schedule (MPFS), CPT 0402T is the Category III code for CXL and there is no assigned global period. The surgeon defines reasonable postoperative care. As a point of comparison, a similar procedure is 65436 (removal of corneal epithelium; with application of chelating agent, e.g., EDTA) which is assigned a 90 day postop period.


Q  Following CXL, does a claim for CPT 65778 need a modifier?

A  No. Modifiers 24, 25, 57, 58, 78 and 79 are used on claims where there is a defined global surgery period. Because 0402T has none, these modifiers do not apply. The only pertinent modifiers are RT (right) and LT (left).


Q  What diagnoses apply for PROKERA placement following CXL?

A  CXL is indicated for progressive keratoconus and corneal ectasia. It is important to use a different diagnosis for the PROKERA procedure: the non-healing epithelial defect or iatrogenic insult that resulted after the CXL procedure. It can be coded with two ICD-10 codes:

S05.01XA – Injury conjunctiva and corneal abrasion w/o fb, right eye, initial encounter

S05.02XA – Injury conjunctiva and corneal abrasion w/o fb, left eye, initial encounter

In the unusual case of an adverse event, ICD-10 also includes:

H59.89 – Other postprocedural complications and disorders of eye and adnexa, NEC


Q  What is the Medicare allowed amount for 65778?

A  The 2017 national Medicare allowed amount for 65778 performed in-office is $1,440. This is adjusted by local indices, so actual payment will vary.
Other payers set their own fee schedules, which may differ considerably from the Medicare rates. Providers should check coverage and authorization requirements of their local payers prior to performing PROKERA insertion for this, or any, indication.


Provided Courtesy of Bio-Tissue  (888) 296-8858

Last updated April 25, 2017


The reader is strongly encouraged to review federal and state laws, regulations, code sets (including ICD-10), and official instructions promulgated
by Medicare and other payers. This document is not an official source nor is it a complete guide on reimbursement. The reader is reminded that
this information, including references and hyperlinks, changes over time, and may be incorrect at any time following publication.

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