17 Facts and Business and Legal Issues About Premium Intraocular Lenses for Cataract Patients

Here are 17 facts and business and legal issues about premium intraocular lenses, a recent technology that can free many cataract surgery patients from having to wear eyeglasses.

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Medicare patients can be charged extra for them.
1. In one of the few exceptions to its “balance billing” prohibition, CMS began allowing surgeons in 2005 to bill Medicare patients for the extra cost of premium IOLs. Medicare pays at the price level for insertion of a standard IOL and the patient picks up the difference, generally $2,000-$4,000 per eye.

2. While CMS does not impose a set limit for the patient’s share of the cost, it expects eye surgeons to justify the bill when queried, breaking down charges such as additional tests, extra follow-up visits and plans for future enhancements, according to Dan Durrie, MD, an eye surgeon in Overland Park, Kan.

3. Medicare also allows practices to bill the patient extra for toric IOLs, which correct astigmatism but still require eyeglasses and cost the patient about $1,000 per eye.

4. While only about 10 percent of cataract surgery patients opt for premium IOLs, cataract surgeons say the new lenses represent a vast potential market. Cataracts are the number one eye problem, even greater than presbyopia (farsightedness).

There are three brands of premium IOLs on the U.S. market.
5. Alcon Laboratories’ AcrySof ReSTOR and ReSTOR Aspheric IOL are multifocal lenses, meaning they provide multiple retinal images, similar to bifocal eyeglasses.

6. Abbot Medical Optics makes another multifocal lens called ReZoom.

7. Bausch & Lomb makes Crystalens and Crystalens HD, which are accommodating IOLs. These lenses are connected to the eye’s ciliary muscle and mimic the eye’s natural accommodation to near, intermediate and far vision.

Surgeons should be offering these lenses to cataract patients.

8. Eye surgeons who don’t offer premium IOLs as an option are ignoring guidelines for informed consent of patients from the Ophthalmic Mutual Insurance Co., which insures ophthalmologists for professional liability coverage. “OMIC feels that it is advisable to inform patients of the types of options as part of the informed consent discussion,” the carrier’s risk management recommendations state.

9. Usage of IOLs by cataract surgeons can be as high as 50 percent, according to Michael J. Parshall, principal of Michael J. Parshall HealthCare Consulting and a consultant with the Health Care Group in Plymouth Meeting, Pa. While some cataract surgeons refer patients who want premium IOLs to other surgeons, some may be neglecting to offer the option to patients.

10. Premium IOLs alter surgeons’ relationship with patients, according to cataract surgeons who insert the lenses. The subspecialty is not used to asking patients to pay large amounts of out-of-pocket charges, as LASIK surgeons routinely do.

Premium IOL patients are more likely to be dissatisfied.
11. The biggest challenge with premium IOLs is dealing with dissatisfied patients, who are more likely to be dissatisfied than patients with regular IOLs, cataract surgeons say. Since patients pay more for the goal of perfect vision, they can be unhappy when the reality doesn’t match expectations.

12. Surgeons report that premium lenses need to be more accurately positioned than a standard IOL for cataract surgery.

13. After lens insertion, at least 5 percent of premium IOL patients need refractive surgery, which is not needed after standard IOLs are inserted, according to Eric Donnenfeld, MD, a cataract surgeon in Rockville Centre, N.Y.

14. Up to 20 percent of patients, depending on the brand of premium lens, still need glasses some of the time, according to FDA trials.

15. When outcomes of cataract surgery do not meet expectations, “patients are more apt to complain not only to their ophthalmologist, but to acquaintances, insurance companies, regulatory agencies, malpractice attorneys, and, in increasing numbers, even to the Ethics Committee of the American Academy of Ophthalmology,” OMIC stated.

Legal issues to remember.
16. Surgeons and ASCs should not bill patients or payors for lenses they are provided for free by manufacturers or distributors.

17. The method of billing for premium lenses and the relationship between the ASC and how the ASC may sell the lens to the physician who then bills the patient is a relationship that must be carefully reviewed to ensure that it doesn’t raise antikickback concerns.

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