Presbyopia-correcting IOLs

Surgeons and facilities must bill separately for covered and noncovered services.

Your established Medicare patient with cataracts complains of worsening vision and difficulty with daily activities, and he wants to proceed with cataract surgery. He has heard about new IOLs that may reduce his dependency on eyeglasses and is interested in them.

You explain to him that a presbyopia-correcting IOL is intended for visual correction in adult patients after a cataractous lens has been removed, and it is specifically for those who desire increased spectacle independence across a range of distances. You further explain that this innovative technology is quite different then a conventional IOL that restores visual acuity at one distance only, usually far.

You inform him that three lenses are currently available, and each employs a different design. The three lenses currently on the market are the crystalens by eyeonics, the AcrySof ReSTOR apodized diffractive optic IOL by Alcon and the ReZoom by Advanced Medical Optics. You and the patient decide to proceed with cataract extraction with a presbyopia-correcting IOL.

What type of chart documentation is required for this IOL, and what additional information needs to be provided to the patient?

Documentation should support the medical necessity for cataract surgery. The commonly accepted indications for cataract surgery include the following:

There is objective evidence of a cataract
The patient has reduced Snellen visual acuity
The patient has lifestyle complaints
There is good prognosis for improvement
The patient is tolerant of the procedure
The patient desires surgery

Many local medical review policies or local coverage determinations include specific visual acuity or other requirements. For carrier specific information, check your local carrier Web site. In addition, it is advisable to document that the patient elected the presbyopia-correcting IOL instead of a traditional IOL after being advised of the risks, benefits and alternatives.

The patient must also be informed about his financial responsibility with the election of a presbyopia-correcting IOL. The basic charges of the surgeon and hospital or ASC for standard cataract surgery remain a covered Medicare benefit. Additional services related to presbyopia correction, including diagnostic tests (eg, corneal topography, pachymetry, wavefront aberration testing), refractive keratoplasty, and the upgrade to the deluxe IOL, are not covered.

On May 10, 2005, the Centers for Medicare and Medicaid Services published Ruling No. 05-01 clarifying payment rules and providing access to these presbyopia-correcting IOLs for Medicare beneficiaries. The effective date was May 3, 2005. The ruling states, “The beneficiary is responsible for payment of that portion of the facility charge that exceeds the facility charge for insertion of a conventional IOL following cataract surgery … The beneficiary is responsible for payment of physician services attributable to the noncovered functionality of a presbyopia-correcting IOL … The physician may take into account the additional physician work and resources required for insertion, fitting, and vision acuity testing of the presbyopia-correcting IOL compared to insertion of a conventional IOL.”

Because patients are deeply concerned about their financial obligations, it is helpful to anticipate their desire for information and break down the fees in a readily understandable fashion. A solitary all-inclusive number does not segregate the charges that will be reimbursed by insurance from the noncovered fees and raises the specter of balance-billing violations. Most important, the patient wants to know what he owes, and the provider should take the opportunity to collect payment for the noncovered items and services in advance of the procedure.

In the schema outlined in the Table above, the covered services would probably be treated as assigned claims, subject to a contractual adjustment which would be written off. The noncovered items and services would not be discounted. Patients pay the physician for noncovered services and pay the facility for the noncovered portion of the presbyopia-correcting IOL.

Each surgeon must construct an individual protocol for refractive services and determine which are appropriate on a case-by-case basis. Once constructed, the surgeon needs to establish a reasonable fee for the refractive package considering the services included, also taking into account what the local market will accept.

As for the IOL, there are two pieces: one part covered, and one part noncovered. As a point of reference, Medicare has valued conventional IOLs at $150 in its determination of ASC payment rates, so the covered portion is part of the standard facility fee. Therefore, the noncovered charge to upgrade to a deluxe IOL is any additional charge beyond $150. If there is any markup on the IOL to compensate for shipping, handling, taxes, etc., it should be modest. Unrealistic markups raise balance-billing questions.

Medicare does not require specific documents when the patient elects implantation of this IOL. But patients must be notified in advance of financial responsibility and agree to pay for the noncovered items and services associated with this IOL. For Medicare beneficiaries with visually significant cataract, the August 5, 2005, CMS Transmittal 636 advocates the use of a Notice of Exclusion from Medicare Benefits (NEMB) to clearly identify the noncovered items and services and the associated fees. The facility and surgeon should each execute an NEMB. You do not need to include these forms with the claim for reimbursement.