Federal regulators caution prescribers’ adherence to both the Contact Lens and Eyeglass rules as the AOA reminds doctors of prescription release requirements and compliance resources available.
On June 3, the Federal Trade Commission (FTC) announced it sent 37 letters to contact lens prescribers notifying them that a consumer complaint had been filed regarding Contact Lens Rule compliance. While not formal investigations, the FTC letters requested additional information on rule compliance in these practices. Additionally, the FTC closed an investigation into potential compliance violations within an eye care group, deeming a misunderstanding of the Contact Lens and Eyeglass rules and the group’s effort to modify its compliance.
Revisions to the FTC’s Contact Lens Rule, taking effect in April 2021, and the Ophthalmic Practice Rules (Eyeglass Rule), taking effect in September 2024, both outline additional requirements on prescribers; namely:
- Contact Lens Rule. Prescribers are required to provide patients—or a patient’s agent—a copy of their contact lens prescription at the conclusion of their fitting and must retain documentation indicating patients received their prescriptions for at least three years. Practices must seek patient consent to send contact lens prescriptions electronically, such as through a portal or email.
- Eyeglass Rule. Prescribers are required to provide patients with a copy of their prescription after completing any refractive eye examination and must retain documentation indicating patients received their prescriptions for at least three years. Practices must seek patient consent to send contact lens prescriptions electronically and are required to update their consent when changes to digital delivery are made.
Under both rules, prescribers are prohibited from charging additional fees or requiring a signed wavier for releasing prescriptions. Also, the rules prohibit prescribers from requiring a patient to buy contact lenses or eyeglasses from them, as well as prohibiting prescribers from refusing to perform an eye exam unless the patient buys such products from them.
The FTC warns violations may result in administrative subpoenas and civil penalties of up to $53,088 per violation.
Federal enforcement of internet retailers, scams
Coming almost one year to the date of the FTC’s finalization of the Ophthalmic Practice Rules (Eyeglass Rule) in June 2024, the warning letters are noticeably absent of any reprimand against infringing mass retailers. The AOA continues to report to the agency documented instances of illegal medical device sales and internet scammers taking advantage of both the Contact Lens and Eyeglass rules. The AOA will continue working to expose threats to the health and safety of our patients and fully enforce federal and state consumer protection laws.
Should doctors encounter or suspect illegal or unsafe medical device sales, please report those to the Food and Drug Administration and share a de-identified case report to AOA in order to continue to provide regulators with this evidence.
Rule compliance resources, toolkits
To help optometric practices remain in compliance with the Contact Lens and Eyeglass Rules, the AOA and FTC offer the following resources:
- AOA’s FTC Contact Lens Rule Compliance Toolkit. This toolkit includes information and guidance regarding how prescribers can comply with these regulations.
- Prescription requests from retailers. This legal advisory from the AOA’s general counsel provides information on how to respond to prescription requests from contact lens sellers.
- FTC’s Contact Lens Rule: A Guide for Prescribers and Sellers. This FTC-provided resource is compiled by the agency to assist prescribers.
- FTC’s Complying with the Eyeglass Rule. This FTC-provided resource is compiled by the agency to assist prescribers.
Should you have additional questions about compliance and either rule, not covered as part of these resources, please send your question to askaoa@aoa.org.
