Compliance issues related to presbyopia-correcting IOLs

An expert in compliance issues answers frequently asked questions about billing for presbyopia-correcting IOLs. Part 2 in a series.

Issue: January 1, 2006

ByAlan E. Reider, JD, MPH

This is the second in a series of articles addressing regulatory issues surrounding the recent approval for Medicare coverage of presbyopia-correcting IOLs. Readers should refer to the December 1, 2005, issue of Ocular Surgery News (page 20) for part 1 of this series.

1. May a manufacturer sell a presbyopia-correcting IOL directly to a physician?

Yes. There are no statutes or regulations that prohibit an IOL manufacturer from selling IOLs directly to physicians.

It is important to note, however, that when a physician purchases the IOL, the physician is accepting the responsibility and related liability to ensure that the IOL is maintained and stored in a manner consistent with the labeling.

Alan E. Reider

Allison Weber-Shuren

2. Who may a physician charge for the IOL, and are there any limits to that charge?

A physician may not charge the Medicare program, nor is it likely that the physician will be able to charge commercial insurers for the “covered” portion of the IOL. There simply is no mechanism to do so. More than likely, the physician will provide the IOL to the ASC or hospital and is free to charge the ASC or hospital for the lens. It is important, however, that the physician limit the charge to the facility to the cost to the physician, ie, the physician should not profit from the sale of the IOL to the facility. This restriction is due to the fact that the physician will be referring the patient to the facility. Any profit resulting from the sale of the IOL to the facility could be viewed as something of value and constitute a kickback for that referral.

Finally, it may be possible for the physician to charge the patient for the IOL as part of a global fee for additional services performed. Under these circumstances, however, there does not appear to be any mechanism to collect from Medicare or commercial insurers for the “covered” portion of the IOL.

3. If a physician purchases an IOL, are there any Food and Drug Administration or licensing laws that apply?

As long as the physician does not repackage, relabel or process the IOL in any manner when the physician resells the IOL, the physician should meet the definition of a “wholesale distributor” and qualify for an exemption from any FDA registration requirements.

It is possible, however, that state law may require a physician to become licensed or registered as a distributor of drugs and devices. Physicians should check to determine the requirements with respect to their respective state law.

4. Are there any marketing limitations that apply to the presbyopia-correcting IOL?

While there is no limitation on a physician educating patients within his practice about the availability of presbyopia-correcting IOLs, technically the FDA restricts the promotion of off-label procedures outside of the office, such as advertising a procedure on a practice’s Web site.

In fact, in one case the FDA has issued warning letters to a surgical practice in which the practice Web site made reference to an off-label cosmetic use of a medical device. Practices are cautioned whenever they promote an off-label use.

Next month

We will have the last installment in this series, and will focus on comanagement issues in connection with implanting the presbyopia-correcting IOL.

For Your Information:

Alan E. Reider, JD, and Allison Weber Shuren, MSN JD, can be reached at Arent Fox PLLC, 1050 Connecticut Ave. NW, Washington, DC 20036; 202-857-6462.