FTC Releases the Final “Eyeglass Rule”

(PRESS RELEASE) CITY, STATE — The Federal Trade Commission published the updated Ophthalmic Practice Rules (Eyeglass Rule) 16 CFR Part 456 on July 26, 2024. The commission found that prescribers are still failing to provide their patients with their prescription at the completion of the eye exam, and that an automatic-release rule coupled with required documentation of that release is the best means for addressing this.

To read the final rule text, click here.

The main takeaways from this rulemaking are:

1. Ophthalmologists and optometrists are to provide a copy of the patient’s prescription immediately after performing a refractive eye exam and before offering to sell the patient ophthalmic goods, whether the patient requests the prescription or not. A prescriber, however, may refuse to provide the prescription until after the patient pays for the refractive eye exam, so long as the prescriber would have required immediate payment had the exam revealed that no ophthalmic goods were required. Presentation of proof of insurance is deemed payment.
2. Prescribers cannot make the availability of a refractive eye exam conditioned on the patient agreeing to purchase ophthalmic goods from the provider. The prescriber cannot charge the patient an additional fee for the prescription, nor may it attempt to waive its professional liability by including such language on the prescription or by requiring the patient to disclaim the prescriber’s potential liability for the accuracy of the exam.
3. The definition of “prescription” includes all information required by state law. To date, only Kansas, Mass, Alaska, and New Mexico have state laws requiring the disclosure of pupillary distance as part of the Rx. In other words, other than in those states, the prescriber does not need to provide the patient PD information as part of the physical or digital prescription that they must provide after a refractive eye examination.
4. If a digital copy of the prescription is provided, then the prescriber must identify how it will be made available—text, email, or portal—and it must be made available in a downloadable and printable format. The use of a digital download first requires the patient to provide the prescriber verifiable and affirmative consent before receiving the prescription digitally; the prescriber must retain the consent for 3 years. The prescriber must also retain evidence for three years that the prescription was sent, received or otherwise made available for download and printing.
5. When a paper copy is provided, the patient must acknowledge receipt of the Rx, , and the prescriber must retain a copy of that receipt for 3 years. The FTC provides sample language that can be used to satisfy this requirement (“My eye care professional provided me with a copy of my prescription at the completion of my examination”) or the prescriber can draft its own similar language.
6. If a patient refuses to sign a confirmation of release, then the prescriber shall note the patient’s refusal and sign it;
7. Prescribers who do not “have a direct or indirect financial interest in the sale of eye wear, including, but not limited to, through an association, affiliation or co-location with an optical dispenser” are excused from the requirements of paragraphs 4, 5 and 6 above.

Should you have any questions, please contact The Vision Council’s vice president: membership, government relations & technical affairs, Michael Vitale via email, mvitale@thevisioncouncil.org or Rick Van Arnam, The Vision Council’s Regulatory Affairs Counsel, at rvanarnam@barnesrichardson.com.