The Federal Trade Commission today announced it is seeking additional public comment about newly proposed changes to the agency’s Contact Lens Rule. The new proposal follows an extensive review and consideration of thousands of public comments and material received by the Commission 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 Commission is now seeking comment on modifications 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 believes the newly developed modifications will achieve the goals of its original proposal, while imposing less of a burden on prescribers.
As detailed in a Supplemental Notice of Proposed Rulemaking to be published shortly, 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; or
- 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.
Further, 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.
Finally, the FTC 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 therefore 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.
The FTC also 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 Contact Lens Rule
In place since August 2004, the Rule helps to promote competition in the retail sale of contact lenses by facilitating consumers’ ability to comparison shop for them. It imposes obligations on both eye-care prescribers and contact lens sellers. The prescriber must automatically provide the patient with a complete copy of the contact lens prescription after completion of a contact lens fitting, and also must verify or provide the prescription to authorized third parties. The Rule also requires that contact lens vendors sell contact lenses only in accordance with a valid prescription the seller has received from either the patient or prescriber, or has verified via direct communication with the prescriber.
Recent Procedural History
In September 2015, the FTC sought public comment on the costs, benefits, and impact of the Contact Lens Rule as part of its systematic review of all current FTC rules and guides. The Commission received more than 600 comments from interested parties and stakeholders. After reviewing these comments and other evidence, the agency determined it would be beneficial to increase compliance with the Rule’s automatic prescription release requirement.
Accordingly, in a November 2016 Notice of Proposed Rulemaking (NPRM), the FTC proposed amending the Rule to require that contact lens prescribers obtain a signed acknowledgement after releasing a contact lens prescription to a patient, and maintain that acknowledgment for at least three years. In addition, to conform the language of the Rule to the language of the Fairness to Contact Lens Consumers Act, the Commission proposed amending Section 315.5(e) to remove the words “private label.” The FTC held a public workshop in Washington, DC, in March 2018 to examine the contact lens marketplace and proposed changes to the Rule. In response to the NPRM and the workshop notice, the Commission received over 7,000 additional comments.
The Supplemental NPRM announced today explains the FTC’s current proposal to modify its signed-acknowledgement proposal and amend other sections of the Rule, and summarizes the comments relevant to its proposals.
The Commission vote approving publication of the Supplemental NPRM in the Federal Register was 5-0. Written comments must be received within 60 days of the date the notice is published. Comments can be filed electronically at: regulations.gov, by following the instructions on the web-based form.
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