Centers for Medicare & Medicaid Services
Ruling No. 05-01
May 3, 2005
TITLE: Requirements for Determining Coverage of Presbyopia-Correcting Intraocular Lenses that Provide Two Distinct Services for the Patient: (1) Restoration of Distance Vision Following Cataract Surgery, and (2) Refractive Correction of Near and Intermediate Vision with Less Dependency on Eyeglasses or Contact Lenses
In general, items or services covered by Medicare must satisfy three basic requirements: (1) they must fall within a statutorily-defined benefit category; (2) they must be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body part; and (3) the item or service must not be excluded from coverage.
A conventional intraocular lens (IOL) is covered when implanted following cataract surgery.
Medicare specifically excludes certain items and services from coverage, including eyeglasses and contact lenses. The Congress, however, has provided an exception for one pair of eyeglasses or contact lenses covered as a prosthetic device furnished after each cataract surgery with insertion of an IOL.
CONCLUSION
The statute specifically states that one pair of conventional eyeglasses or contact lenses furnished subsequent to each cataract surgery with insertion of an IOL is covered. A single presbyopia-correcting IOL essentially provides what is otherwise achieved by two separate items: an implantable conventional IOL (one that is not presbyopia-correcting), and eyeglasses or contact lenses. Although presbyopia-correcting IOLs may serve the same function as eyeglasses or contact lenses furnished following cataract surgery, IOLs are neither eyeglasses nor contact lenses. Therefore, the presbyopia-correcting functionality of an IOL does not fall into the benefit category and is not covered. Any additional provider or physician services required to insert or monitor a patient receiving a presbyopia correcting IOL are also not covered. For example, eye examinations performed to determine the refractive state of the eyes following insertion of a presbyopia-correcting IOL are non-covered.
Regardless of site-of-service for insertion of a presbyopia-correcting IOL, the beneficiary is responsible for payment of physician services attributable to the non-covered functionality of a presbyopia-correcting IOL inserted following cataract surgery. In determining the physician service charge, 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.
The beneficiary is responsible for payment of the charges for physician services that exceeds the physician charge for insertion of a conventional IOL following cataract surgery.
http://www.cms.hhs.gov/rulings/CMSR0501.pdf
Comment: One of the more difficult issues facing Medicare administrators is deciding which technological advances should be included in the Medicare program, considering the continuing escalation of health care costs.
Everyone would agree that expensive technology that fails to provide any significant benefit should be excluded from coverage. Likewise, technology that has been proven to be beneficial, and is not inordinately expensive, should be included. The difficult decisions involve technology that is very expensive and provides only a questionably marginal benefit. Most would agree that such care might reasonably be excluded in the absence of adequate evidence-based benefit, unless you just happened to be the individual who wanted access to that service. But the line must be drawn, and this seems to be a sensible approach.
Where has the line been drawn with intraocular lenses (IOLs)? IOLs are covered when implanted in conjunction with cataract surgery, whereas eyeglasses or contact lenses are not covered for presbyopia. But there is an exception. One pair of eyeglasses or contact lenses is covered after insertion of an IOL following cataract surgery.
This ruling then goes on to make a very fine technical distinction between presbyopia-correcting IOLs and the post-cataract surgery eyeglasses/contact lenses. The IOL is covered, the eyeglasses are covered, but the functionality of the IOL that corrects presbyopia is not covered because it has been shifted from the eyeglasses to the IOL!
What is unique about this ruling is that it allows Medicare to pay an amount that a conventional IOL would cost, but it requires the patient to pay for additional costs and services for the presbyopia correction of the IOL.
Because these are excluded services, they may also be excluded from Medicare fee determinations. It can be anticipated that the additional out-of-pocket expense for the patient will be significant.
Thus enters two-tiered care within the traditional Medicare program. And we didn’t even have to go to the private Medicare Advantage options to accomplish it. Limited income patients receive outdated technology and one pair of eyeglasses to last a lifetime, whereas more affluent patients receive the latest technology which corrects their presbyopia for life.
This is a beneficial service which is not inordinately expensive. It should be completely covered by Medicare.
Now that the principle of a two-tiered Medicare program has been established, what might we anticipate? The cost of any new technological advance that is truly innovative (i.e., not a defined Medicare benefit) can be passed on to the patient, at retail prices, beyond the Medicare approved fees of the service without the new technology. Thus the wealthy will receive the benefits of the newest technology whereas those with modest resources will not: the definition of a two-tiered system.
We can get it right. With a universal social insurance program, all reasonably affordable, beneficial services can be made available to everyone with legitimate medical needs. Let’s fix Medicare, and then use it to cover everyone.