New technology for complicated cataract cases
FDA-approved capsular tension rings stabilize the lens capsule in difficult procedures.
In 2002, the most recent year for which data is available, Part B Medicare paid for 1.7 million cataract operations. The majority of these cases likely yielded good results, and in all probability, the surgeon performed them without difficulty. Unfortunately, a small percentage of patients have conditions that complicate cataract surgery. For some of these complicated cases, support has arrived. A device newly approved by the Food and Drug Administration – the capsular tension ring – may be just what the doctor ordered.
What is a CTR?
A capsular tension ring (CTR) is a prosthetic device designed to stabilize and provide support to the lens capsule in the presence of weak or partially absent zonules in adult patients during cataract surgery. Made of PMMA, it is placed in the capsular bag and intended to be permanent. Conditions associated with weak or partially absent zonules may include cases of primary zonular weakness (e.g., Marfan’s syndrome), secondary zonular weakness (e.g., trauma or vitrectomy), zonulysis, pseudoexfoliation and Marchesani’s syndrome. Additional indications for CTR use may include lens luxation and repositioning of a decentered IOL.
The FDA approved the Morcher capsular tension ring in October 2003. Developed by Morcher GmbH of Stuttgart, Germany, it is distributed within the United States by FCI Ophthalmics, Inc. Types 14, 14A and 14C received the approval. Size differentiates the three types. Additional versions of the ring are still considered investigational pending continued trials and await FDA approval.
Ophtec USA, a subsidiary of Ophtec B. V. of the Netherlands, received FDA approval of the StabilEyes capsular tension ring this April. Advanced Medical Optics, Inc. will distribute the device in North America.
By some estimates, complex cataract surgery (CPT 66982) accounts for only 2% of all cataract extractions with IOL. Recent data published by CMS for 2002 claims history supports this estimation. However, ophthalmic practices vary and some surgeons may perform this procedure more frequently by virtue of the extraordinary populations they serve. Other surgeons may elect to avoid these difficult cases altogether and never report 66982.
For the surgeon using the CTR, the procedure would be coded with 66982 because it fits within the code’s definition:
Extracapsular cataract removal with insertion of an intraocular lens prosthesis (one stage procedure), manual or mechanical technique (e.g., irrigation and aspiration or phacoemulsification), complex, requiring devices or techniques not generally used in routine cataract surgery (e.g., iris expansion device, suture support for intraocular lens, or primary posterior capsulorrhexis) or performed on patients in the amblyogenic developmental stage.
As evidence in support of 66982, the operative report should include a detailed discussion of the CTR insertion to distinguish this procedure from 66984. To facilitate reimbursement, additional preoperative diagnoses on the operative report and the claim are encouraged.
Medicare’s national allowable for 66982 is $899 in 2004. This is a 31% premium above standard cataract surgery (66984). This amount is adjusted by local indices, so actual reimbursement will vary.
The CTR is sold by the distributor to a hospital or an ambulatory surgery center (ASC). Therefore, a hospital outpatient department or ASC is reimbursed for the device because it is supplied to the patient by the facility. The surgeon who uses the CTR is not the supplier of the prosthetic device and cannot be reimbursed for it.
Ambulatory surgery centers are reimbursed separately for the CTR. Under the Medicare law SSA §1833(i)(2)(A), a prosthetic device such as the CTR is a Medicare benefit and deserves separate reimbursement when it is not specifically part of the ASC facility fee. The coverage rule can be found in the Medicare Carriers Manual at MCM §2265.4, which states in part: “Prosthetic devices, other than intraocular lenses (IOLs), whether implanted, inserted, or otherwise applied by covered surgical procedures, are covered, but are not included in the ASC facility payment amount.”
The ASC includes a separate entry on its claim form for the CTR. Devices and certain supplies are identified by Healthcare Common Procedure Coding System (HCPCS) codes. At this time, there is no specific HCPCS code to report the CTR. For now, an ASC may report the CTR using a miscellaneous HPCPS code L8699 “Prosthetic implant, not otherwise specified” on the CMS-1500 claim form. For payers desiring a UB-92 claim form, the revenue code 278 “Other implants” is entered to describe the CTR.
Claims for miscellaneous codes generally require support documentation to facilitate payment. Useful information includes a description of the device, the purpose of the device, a statement concerning FDA approval, an invoice showing acquisition cost and the pertinent regulation that warrants additional reimbursement. There is no predefined Medicare reimbursement amount for miscellaneous devices.
If the CTR is implanted in a hospital outpatient department, however, there is no separate reimbursement for the device. It is included in the hospital outpatient department facility reimbursement.
As surgeons continue to seek ways to improve surgical outcomes, the availability of the CTR for complicated cases may be the answer for challenging cataract procedures.
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