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Legal Update
Open Your Eyes to Refractive IOLs' Legal Issues
Nora Liggett
Publish Date: October 10, 2007

Medicare payment changes never happen as quickly as medical technology advances, but CMS has done a pretty good job keeping up with the advent of and demand for refractive-IOL-implanting procedures. While the payment regulations for these procedures give surgeons and Medicare patients many more options than before, they also create practical payment issues and increase the chances that you may unwittingly violate Medicare payment or fraud and abuse laws. Here are four keys to ensure that your arrangements with surgeons and patients for payment comply with both Medicare billing rules and the federal Anti-kickback Statute.

How You Get Paid for IOLs

Here are two coverage rulings you should be aware of when it comes to coding and billing for implanting presbyopia-correcting IOLs in Medicare patients.

? Transmittal No. 636 to the Medicare Claims Processing Manual. This May 2005 guidance clarified CMS Ruling No. 05-01, which for the first time expressly let Medicare patients opt for presbyopia-correcting IOLs after cataract extraction. CMS acknowledged that a presbyopia-correcting IOL is intended to provide what is otherwise achieved by two separate Medicare reimbursable items: an implantable conventional IOL (one that is not presbyopia-correcting) and eyeglasses or contact lenses to provide refractive correction. The ruling lets Medicare patients request presbyopia-correcting IOLs as long as they pay the additional expenses associated with the lenses and the services in implanting them.

? Transmittal No. 914 to the Medicare Claims Processing Manual. CMS has a process under which manufacturers may request annually that one or more of their IOLs be designated "new technology IOLs," which means you can receive an additional $50 payment when you implant these lenses in Medicare beneficiaries in an ASC setting. This particular April 2006 guidance (go to www.cms.hhs.gov/ASCPayment/05_NTIOLs.asp for an updated list) announced that certain IOLs that correct for corneal spherical aberrations would qualify for the additional new technology payments for the next five years.

- Nora L. Liggett, JD

1. Bill for a traditional IOL. Have your billing staff code for the removal of a cataract with insertion of a conventional IOL, regardless of whether a conventional or presbyopia-correcting IOL was inserted. In both cases, payment for the lens itself is packaged into the payment for the surgical cataract extraction and lens replacement procedure. The facility fee is the same for both kinds of IOLs with respect to charges for follow-up visits as well as for the surgery. The only exceptions are lenses classified as "New Technology IOLs" - in that case, you can bill Medicare for an additional $50 per lens (see "How You Get Paid for IOLs" on page 24).

2. Charge a reasonable difference. While CMS has declined to give specific pricing information, its guidelines clearly state that you should charge patients a fair amount for the difference in price between presbyopia-correcting and conventional IOLs. The agency said in Transmittal No. 636 that in determining the beneficiary's liability, you (and the surgeon) should try to account for any additional work and resources required for insertion fitting, vision acuity testing and monitoring of the presbyopia-correcting IOL that exceeds the work and resources attributable to insertion of a conventional IOL. The extra money should also be enough to ensure that you won't appear to be giving patients improper inducement to have their procedures at your facility.

And yet you must be careful to ensure you don't charge what's viewed as an excessive amount, as that could lead to allegations that you've inflated the charges for a non-covered service in order to supplement the Medicare payment for the Medicare-covered services, a violation of the Medicare assignment or limiting-charge rule. As a general rule, you should be safe as long as you charge an amount equal to your additional costs in providing the presbyopia-correcting IOL, plus a reasonable markup.

3. Ensure patients know their payment responsibility. Although a Medicare Advanced Beneficiary Notice isn't technically required because the presbyopia-correcting IOL doesn't fall within a Medicare benefit category, CMS makes clear in Transmittal No. 636 that it's a good idea for you and the surgeon to use this written notice to inform patients that they'll be responsible for an additional fee. At the very least, you should tell patients of their financial responsibility.

4. Take care when procuring the lens. If a surgeon asks whether he can bring the presbyopia-correcting IOLs he purchased direct from the manufacturer, that's fine - there's no rule against it. However, because Medicare's payment to you includes the cost of the IOL, arrange with the surgeon to buy the lens from him for a reasonable price before billing for the procedure - otherwise your bill to Medicare would be a false claim. Be sure to pay the surgeon a reasonable, fair market value price: Pay too much, and you could be subject to the allegation that the excess amount is an inducement to the surgeon for his referrals, a violation of the federal Anti-kickback Statute. If you want to be completely safe, your facility should buy the IOL directly from the manufacturer.

A Quick Glance at Today's IOLs

AcrySof ReSTOR
(800) 862-5266
Price: $895
FYI: Combines the benefits of apodized diffractive and refractive technologies to give patients both a clearer image and improved distance vision, says the company. According to research provided by Alcon, about 84 percent of patients who receive this bilateral IOL achieved a combined uncorrected distance visual acuity of 20/25 or better with near visual acuity of 20/32 or better after the operation compared to 23 percent for multi-focal IOL patients.

(714) 247-8200
Price: $895
FYI: The ReZoom Acrylic Posterior Chamber IOL can give patients a full range of vision through its use of five focusing zones, which are arranged in an alternating pattern of distance-dominance and near-dominance, says the company. This redistributes the light to give patients a full range of vision even in darker conditions, according to the manufacturer, and gives patients a very good chance of no longer needing spectacles.

Crystalens Five-O
(888) 393-6642
Price: $895
FYI: Facilities that encounter unusual cataract cases may want to consider the options the Crystalens Five-O offers. This accommodating IOL is available in an expanded range of 10 to 30 diopters to go beyond the range of current IOLs and is also available in quarter-diopter steps to give surgeons more precise options, says the company. Crystalens is also available in a 12mm overall length (from 10 to 16.75 diopters) to accommodate larger eyes.

Lenstec Tetraflex Presbyopic IOL
(727) 571-2272
Price: Not yet on the market
FYI: This accommodating lens is designed to work with the patient's eye muscles, bending and moving with them to provide a full array of vision. The product is currently in phase III of clinical research and the manufacturer expects it to be on the market by late 2008.

(949) 341-0700
writeMail("[email protected]")
Price: Not yet on the market
FYI: The Synchrony dual optic accommodating IOL features a plus-powered anterior lens and a minus-powered posterior lens joined by a unique spring system, says the company. When the two lenses are close, the eye can perceive distance, but when the ciliary body contracts, the front lens moves forward and changes the focus to intermediate or near vision. In January, the manufacturer received FDA approval to expand to phase III U.S. clinical trials.