FTC Seeks Additional Comment on Proposed Changes to Contact Lens Rule

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WASHINGTON, D.C.—The Federal Trade Commission announced last Thursday that it is seeking additional public comment about newly proposed changes to its Contact Lens Rule, which has been in place since 2004. The new proposal follows an extensive review of thousands of public comments and material received by the FTC between 2015 and 2018, including “surveys, studies, analyses, and information generated at an FTC workshop devoted to the Rule and the evolving contact lens marketplace,” the agency said in a press release.

In particular, the agency is seeking comment on changes to its earlier proposal to enhance compliance with the Fairness to Contact Lens Consumers Act’s requirement that prescribers automatically provide their patients with a copy of their prescription upon completion of a contact lens fitting. The FTC said it believes the newly developed modifications “will achieve the goals of its original proposal, while imposing less of a burden on prescribers.”

The issue of asking patients to sign an acknowledgement form noting that they had received a copy of their CL prescription and prescription verification has been a contentious issue during the review process. As VMAIL reported in 2018 the American Optometric Association opposed an earlier FTC proposal requiring doctors to secure and retain patient acknowledgements following release of contact lens prescriptions on the grounds that it is onerous for its members. Consumer advocacy groups such as Consumer Action support the proposal, saying it would make it easier for consumers to shop for contact lenses.

The proposed Rule, which will be published shortly, stipulates that after a contact lens fitting, prescribers would have to satisfy a new Confirmation of Prescription Release requirement in one of several ways:

• Requesting that the patient acknowledge receipt of the contact lens prescription by signing a separate confirmation statement.
• Requesting that the patient sign a prescriber-retained copy of the prescription that contains a statement confirming the patient has received it.
• Requesting that the patient sign a prescriber-retained copy of the sales receipt for the examination that contains a statement confirming the patient received the prescription.
• Providing the patient with a digital copy of the prescription, and retaining evidence that it was sent, received, or made accessible, downloadable, and printable.
The prescriber would have to maintain evidence that they satisfied the Confirmation of Prescription Release requirement for at least three years.

The FTC also seeks comment on newly recommended Rule modifications affecting prescribers in several other ways. First, by adding to the Rule a definition of the term “provide to the patient a copy,” the Commission proposes to allow prescribers to provide patients with a digital copy of their prescription instead of a paper copy, with the patient’s consent. Second, the FTC recommends requiring prescribers to provide an additional copy of a patient’s prescription to a designated agent of the patient within 40 business hours of receipt of the request.

To address concerns about incomplete or incomprehensible automated telephone verification messages, the FTC proposes several new requirements for sellers who use such messages to communicate with prescribers, including requiring that the information be delivered in a slow and deliberate manner and at a reasonably understandable volume, and requiring that prescribers be able to repeat the message. “The purpose of these proposals is to enable prescribers to fulfill their role as protectors of patients’ eye health by ensuring they can comprehend sellers’ verification requests,” the FTC said.

The FTC also proposes modifications designed to reduce illegal prescription alterations by sellers in violation of the Rule. The Rule already prohibits prescription alteration, but some sellers appear to use passive verification to switch consumers from their prescribed lens to another lens brand. The FTC proposes to amend the prohibition on seller alteration of prescriptions by specifying that alteration includes a seller providing the prescriber with a verification request with the name of a manufacturer or brand other than that specified by the patient’s prescriber, unless such name is specifically provided by the patient.

Additionally, the FTC proposes to amend the Rule to require that sellers provide a mechanism that would allow patients to present their prescriptions directly to the seller. These changes are meant to ensure that consumers receive the lenses prescribed for them, consistent with the intent of the Fairness to Contact Lens Consumers Act and the Rule, the agency said.

The AOA is reviewing the proposed changes to the Rule. In a statement posted on its website, the AOA’s president, Samuel D. Pierce, OD, said, "every AOA member can be certain that this process continues to have our full attention. The AOA Board is conducting a thorough review of the new proposal and we will report on its potential impact on our profession, our practices and our patients. More importantly, just as we have succeeded in doing over the last three years, the AOA and our state associations will lead a mobilization to ensure that optometry continues to be heard by agency officials and members of Congress."

Contact lens maker Johnson & Johnson Vision and other contact lens makers are also reviewing the proposed Rule. Johnson & Johnson Vision issued a statement saying it has worked closely with the FTC during its 10-year review of the Contact Lens Rule to advocate for “regulation that fosters competition and innovation in the contact lens marketplace and prioritizes patient safety and eye health.” The company emphasized that it would continue to support policies “that put the doctor-patient relationship first.”