Article

THE BUSINESS OF CONTACT LENSES

THE 10-YEAR REVIEW OF THE FCLCA AND THE CLR

When the Fairness to Contact Lens Consumers Act (FCLCA) was passed, there were instructions contained therein for the Federal Trade Commission (FTC) to issue rules for the implementation of the FCLCA. As a result, the FTC promulgated the Contact Lens Rule (CLR). Further, there was a required review of the CLR after a prescribed period of 10 years. We have been in that policy review period for more than a year now.

So, why does this matter to the business of contact lens practice? As the chair of the American Optometric Association (AOA) Federal Relations Committee (FRC), to me, that question answers itself. However, to the contact lens prescribers back home, it takes a bit of explaining. The FCLCA and the CLR contain prescriptions and proscriptions that affect lens prescribers and sellers.

Following the edicts of the FCLCA and the CLR is essential to contact lens practice. All of us know (or should know) the requirement to release contact lens prescriptions and the hoops that we have to jump through with passive verification. While complying is a burden, nothing will disrupt your business more than having to respond to a compliance letter from the FTC.

Changes on the Horizon

The 10-year experience of the FCLCA and the CLR has illuminated several issues on which the various stakeholders weighed in during the public comment period of the CLR review process. The AOA FRC and the American Academy of Optometry’s (AAO) Section on Cornea, Contact Lenses, and Refractive Technologies each developed public responses submitted on behalf of the AOA and the AAO, respectively. Further, the AOA FRC has worked hard in support of legislation to improve the FCLCA.

Regarding the CLR, the prescribing community made a compelling case that the CLR was tilted away from patient safety and toward little or no oversight for contact lens sellers. Further, the experience has shown that weak enforcement has favored the lens sellers. The prescribing community made several recommendations to improve lens sellers’ compliance with the FCLCA and the CLR. None of these recommendations were included in the proposed changes to the CLR that the FTC proffered for public comment.

Further, the proposed new CLR requires prescribers to document in writing the release of each contact lens prescription containing the patient’s signature. Prescribers would be required to maintain these records for years.

What the Changes Will Mean

This FTC proposal is concerning for a number of reasons. First, it casts doubt that all eyecare professionals (ECPs) comply with and follow federal law. Second, it tells patients that they have reason to be suspicious of ECPs, which can and will be disruptive to the practitioner-patient relationship.

The business of contact lenses is a regulated activity that is governed by federal and state statutes and regulations. It is incumbent on everyone in that business—manufacturers, prescribers, and sellers—to know what is going on and to get involved.

What You Can Do

By the time this article is published, the comment period for the CLR changes will have passed. However, each of us can get involved with the legislative process. Currently, the AOA FRC is supporting S. 2777 (Contact Lens Consumer Health Act of 2016), sponsored by Sen. Bill Cassidy (R-LA) , which was introduced in April to improve the communications between prescribers and sellers to ensure that lenses are not substituted or sold without a valid prescription. There is a U.S. House of Representatives companion bill as well, HR 6157, sponsored by Rep. Pete Olson (R-TX). If you want to help your practice, then get involved and ask your legislators to support these important patient-centered contact lens safety bills. CLS