At this point, I hope that all of us are up to speed with the new changes to the “Contact Lens Rule.” Put simply, we’d better be, because fees are indicated to be at $42,530 per violation. Yes, this rule is quite serious and, in some instances, a bit confusing. Let’s run through a brief history and then see how we can meet some of the challenging aspects of the new rule.

The Contact Lens Rule: A History

The Fairness to Contact Lens Consumers Act was created to give our patients certain contact lens rights. Part of the act put certain responsibilities on prescribers, but it also called on the Federal Trade Commission (FTC) to develop and enforce these rules. In 2004, the FTC released the Contact Lens Rule, and on Oct. 16, 2020, the FTC released amendments to the rule.

So what were these amendments? The Contact Lens Rule requires prescribers to give patients a copy of their contact lens prescription at the end of a contact lens fitting, even if patients don’t ask for it. In addition, prescribers must maintain a record, for no less than three years, confirming that patients received a copy of their prescription.

While we all are doing our utmost to remain compliant, there are definite challenges to this new regulation. Some concerns in our office are related to how we handle contact lens trials and specialty lens fits. Here are a few tips, approved by the FTC, to deal with these situations.

Managing the Challenges

Contact Lens Trials As we all know, not every contact lens prescription is finalized at the initial date of service. Unfortunately, this does not relieve us of carrying out the new requirements of the rule.

To remain compliant, we have a few options. Let’s say that you provide patients with trial contact lenses to try at home for a few days. According to the FTC, once the prescription is finalized, you can either email patients their prescription or make it available via a patient portal. If you are going to do this, you still need to receive a signature at the original date of service documenting that the patient agreed to have the prescription emailed.

Sending emails means that we need to follow another set of regulations: the Health Insurance Portability and Accountability Act (HIPAA). Remember, email communications containing health information are required to be sent securely or via encrypted email. If you do not have access to these options, according to U.S. Department of Health and Human Services (HHS), it’s OK. The HHS previously clarified (2013) that “covered entities are permitted to send individuals unencrypted emails if they have advised the individual of the risk, and the individual still prefers the unencrypted email.”

Finally, if you don’t email or make prescriptions available on a portal, you could have patients sign the final version of the contact lens prescription when they come to the office to pick it up.

Specialty Lenses When prescribing rigid, hybrid, or even some specialty soft lenses, much goes into determining the final prescription. Unfortunately, the FTC clearly noted in the initial rulemaking that “The Act thus does not permit the Commission by rule to grant an exception to the release requirement for custom-designed soft and rigid gas permeable lenses.”

This presents a challenge, because whether fitting empirically or using diagnostic lenses, a lens needs to be ordered to finalize a prescription. The rule does clarify that “To the extent these lenses are necessary to complete the fitting process, prescribers may charge patients for such lenses as part of the cost of the fitting process, and as such may condition the release of a contact lens prescription on payment of the fitting fee.”

Be Prepared

Please do not take this regulation lightly. As indicated at the outset, the fines are heavy. More information and resources are available through the FTC and through organizations such as the American Optometric Association. CLS

For references, please visit www.clspectrum.com/references and click on document #302.