UPDATE: FTC Issues Contact Lens Rule
The FTC issued their long-awaited Contact Lens Rule on June 23,2020. This unanimous, bipartisan decision is a resounding win for taxpayers and consumers. This Final Rule protects competition and allows for consumer choice. We are also encouraged by the strong concurring opinion offered by FTC Commissioner Slaughter calling on Congress to strengthen the rule further and to examine the issue of brand choice.
FTC Announces Final Amendments to the Agency’s Contact Lens Rule
Changes will help more patients comparison shop for contact lenses
The Federal Trade Commission today announced the approval of a final rule amending the agency’s Contact Lens Rule, which facilitates shopping for contact lenses by requiring prescribers to automatically provide a copy of a patient’s prescription to the patient and to verify or provide prescriptions to third-party sellers.
The Final Rule requires prescribers to request that their patients confirm that they have received their prescription, and allows flexibility in the way the prescription and confirmation are provided.
“Eye doctors are required by law to provide every patient with a copy of his or her contact lens prescription, allowing patients to comparison shop for lenses,” said Bureau of Consumer Protection Director Andrew Smith. “This rule change will help to ensure that eye doctors fulfill their obligations, and will facilitate FTC enforcement of these important requirements.”
Issuance of the Final Rule follows an extensive review and consideration of thousands of public comments and materials received by the Commission between 2015 and 2019, including surveys, studies, analyses, and information generated at an FTC workshop devoted to the Rule and the evolving contact lens marketplace. It also incorporates changes made in response to public comments received following a supplemental notice of proposed rulemaking published in May 2019.
As detailed in a final notice of rulemaking to be published shortly, after a contact lens fitting, prescribers will be required to do one of the following to confirm that a patient received their prescription:
- request that the patient acknowledge receipt of the contact lens prescription by signing a separate confirmation statement;
- request that the patient sign a prescriber-retained copy of the prescription that contains a statement confirming the patient has received it;
- request 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
- provide the patient with a digital copy of the prescription, and retain evidence that it was sent, received, or made accessible, downloadable, and printable.
Prescribers must maintain proof that they satisfied the confirmation of prescription release requirement for at least three years. If a patient refuses to sign a confirmation, prescribers must note this and save it to record their compliance.
The Final Rule also will affect prescribers in several other ways. First, it adds a new definition of the term “provide to the patient a copy,” which will allow the prescriber—with the patient’s verifiable consent—to provide the patient with a digital copy of her prescription instead of a paper copy. When seeking a patient’s consent, prescribers must tell the patient the specific method of electronic delivery they will use, and must keep a record of the patient’s consent to that method for three years. The Final Rule will also require prescribers to provide patients or their designated agents with an additional copy of their prescriptions on request within 40 business hours.
The Final Rule includes several new requirements for sellers as well. To address concerns about sellers verifying prescriptions by leaving incomplete or incomprehensible automated telephone messages with prescribers, sellers who use automated telephone messages for verification must:
- record the entire call and preserve the complete recording;
- start the call by identifying it as a prescription verification request made in accordance with the Contact Lens Rule;
- deliver the verification message in a slow and deliberate manner and at a volume that the prescriber can understand; and
- make the message repeatable at the prescriber’s
The Final Rule also includes modifications designed to reduce illegal prescription alterations by sellers. Under the Final Rule, sellers must make prominently available a way for consumers to present their prescriptions, and must clearly disclose that method. The method of presentation and related disclosure must be provided before requesting the prescriber’s contact information to verify the prescription.
The Contact Lens Rule already prohibits prescription alteration, but the Final Rule defines “alteration” to include sellers providing, as part of a verification request, a brand or manufacturer other than that prescribed to the consumer. There are exceptions, however, for when the seller provides, as part of the verification request, the manufacturer or brand named by the consumer in response to the seller’s request for the manufacturer or brand listed on the prescription. These changes should reduce the incidence of sellers selling consumers lenses other than those that were prescribed. The Final Rule also clarifies that the only permissible substitution involves private label lenses; private label and brand name lenses can be substituted for each other when they are identical lenses made by the same manufacturer.
The Rule changes go into effect 60 days after publication in the Federal Register notice.
The Contact Lens Rule
In place since August 2004, the Rule 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.
The Commission vote approving publication of the final notice of rulemaking in the Federal Register was 5-0, with Commissioner Rebecca Kelly Slaughter issuing a separate statement. The final notice will be published shortly.
The Federal Trade Commission works to promote competition, and protect and educate consumers. You can learn more about consumer topics and file a consumer complaint online or by calling 1-877-FTC-HELP (382-4357). Like the FTC on Facebook, follow us on Twitter, read our blogs, and subscribe to press releases for the latest FTC news and resources.
On November 10, 2016, the Federal Trade Commission (FTC) issued proposed changes to its Contact Lens Rule, the regulatory framework that implements the landmark Fairness to Contact Lens Consumers Act of 2003 (FCLCA).
The FTC’s action followed the agency’s thorough review of the Rule, which included a year-plus-long examination of over 660 comments and numerous studies, surveys and medical evidence.
The most significant proposed change included the addition of a strong consumer rights provision to address the repeated failure of many optometrists to provide consumers with a copy of their contact lens prescription as required by law.
In explaining its proposal, the FTC also rejected almost every proposal and argument made by the American Optometric Association (AOA), contact lens manufacturers and their joint lobbying group, the Coalition for Patient Vision Care Safety. Throughout its proposed rulemaking, the FTC repeatedly noted that these groups failed to provide empirical evidence or data to support their claims, and instead provided only hypothetical examples and anecdotal stories. Notably, since many of these same rejected ideas were included in the misleadingly-named Contact Lens Consumer Health Protection Act of 2016 (CLCHPA, S. 2777 and H.R. 6157), the FTC’s analysis undermines any justification for the anti-consumer bill and highlights why it is so unnecessary.
The key findings and conclusions in the FTC’s proposed rulemaking are as follows:
Requires Signed Acknowledgement of Prescription Release
To address the repeated failure of many optometrists to release prescriptions to consumers following a contact lens fitting, the FTC is proposing to require optometrists to obtain a signed acknowledgement from patients after providing a prescription, and to keep that acknowledgement on hand for three years. This requirement will provide the FTC with a means to track those who are failing to follow this procedure and take action on behalf of consumers’ rights when a case warrants.
Under current law, the FCLCA, optometrists are required to automatically provide prescriptions to consumers at the time of their lens fitting, whether or not the consumer asks for it, so that the consumer can take the prescription to purchase contact lenses from alternative, often lower cost, retailers, if they so choose. In its proposed rulemaking, the FTC noted that the weight of evidence indicated that “compliance with the automatic prescription release provision could be substantially improved.”
In explaining its decision, the FTC stated: “The Commission believes such a provision will help inform patients of their right to their prescriptions, increase the number of patients who receive their prescriptions and, consequently, increase the number of purchases made with initial presentations of complete and valid prescriptions, thus reducing the number of verifications by third-party sellers. The addition of a signed acknowledgment requirement accomplishes the desired objectives with little increased burden on prescribers.”
Rejects AOA and Manufacturer Health Claims
The FTC dismissed claims made by the AOA and manufacturers about health concerns from purchasing lenses through alternative retailers, stating “the Commission has not seen reliable empirical evidence to support a finding that such sales are contributing to an increased incidence, or increased risk, of contact lens-related eye problems.”
And after reviewing all of the medical studies provided by the AOA, the FTC further concluded that “they are not sufficient to reliably demonstrate that purchasing lenses online is a risk factor, or that online purchasers are at a higher risk of developing microbial keratitis or any other ocular complication.” This FTC conclusion is consistent with numerous medical studies that have found no connection between eye health problems and the location where lenses are purchased.
Rejects Argument that “Loopholes” in Current Rule Are Allowing Unsafe Practices
The FTC dismissed arguments made by the AOA and others that the current Contact Lens Rule includes “loopholes” that are allowing or encouraging unsafe practices, such as the purchase of lenses with expired or invalid prescriptions, risky wear and care practices or avoiding regular eye examinations.
In rejecting these arguments, the FTC noted that commenters “did not include any empirical evidence showing that the passive verification mechanism has actually resulted in the renewal of expired prescriptions” and “did not present any data showing that patients are not visiting their eye care practitioners as a result of the passive verification mechanism (or any other Rule provision).” The FTC also noted that “[o]ther examples of patient harm identified by commenters were either hypothetical or anecdotal (such as case reports about the experiences of individual patients).”
The FTC further noted that, despite commenter claims of widespread problems, industry data shows that only 16% of contact lenses are currently purchased from online retailers, implying that health concerns are being overstated or misinterpreted as a problem stemming from online sales.
Rejects AOA and Manufacturer Proposals to Weaken Consumer Protections
The FTC rejected a series of proposals made by the AOA, contact lens manufacturers and the Coalition for Patient Vision Care Safety. These proposals would have gutted the consumer protections in the FCLCA, making it much harder for consumers to purchase lenses from alternative retailers. Notably, since many of these same rejected ideas were included in the anti-consumer CLCHPA bill, the FTC’s analysis undermines any justification for the bill and highlights why it is so unnecessary.
Rejects change that would allow optometrists to block sales by asking a question
The FTC rejected a proposed change to the prescription verification process that would allow optometrists to block a sale to an alternative retailer by simply asking a question or expressing a vague concern, stating: “[T]he Commission believes that such a requirement would undercut the [FCLCA’s] passive verification framework. Such a mechanism could conceivably allow any prescriber to lodge a concern or question and thereby halt the passive verification mechanism.”
Rejects proposal to allow optometrists to select method of communication
The FTC opposed a proposal to allow optometrists to select the method of communication alternative retailers must use in verifying a prescription, noting that the Commission had considered and rejected that idea in its initial rulemaking and specifically allowed for the retailer to determine the communication method. The FTC stated, “[T]he [FCLCA] does not permit prescribers to limit the communication mechanisms sellers may use to submit verification requests.”
Coalition for Contact Lens Consumer Choice members have pointed out that allowing optometrists to select the method of communication would create an undue burden on retailers, who would be required to track the preferred communication method of thousands of optometrists across the country.
Rejects proposal to lengthen 8-hour period for verification
The FTC rejected the idea of lengthening the eight-business-hour time frame during which an optometrist must respond to a prescription verification request, stating: “[T]he Commission believes that the current eight-business-hour time frame is adequate for the vast majority of prescribers. Commenters put forth no empirical evidence that prescriptions are being improperly verified via passive verification due to prescribers not having enough time to respond, and cited no compelling changes in the marketplace that would justify extending the time frame beyond eight business hours. If anything, because of advances in technology, electronic communications, and record-keeping, eight business hours is as appropriate, if not more so, than when implemented in 2004.”
The FTC further noted that it had addressed this issue in its initial rulemaking, explaining that “Congress recognized that consumers may be harmed if they face undue delays in receiving their contact lenses from a seller…”
Rejects restrictions on automated verification systems
The FTC declined to adopt proposals to restrict the use of automated prescription verification systems by alternative retailers, noting that such systems were authorized by the FCLCA and restricting their use “would thus seem to be contrary to Congressional intent to prohibit the use of this technology.”
The FTC further noted that “[T]he Commission has not seen convincing evidence that the volume of automated verification calls they receive each day presents a burden that is not outweighed by the competitive benefits of the Rule, or that these practices frequently result in illegal sales of contact lenses.”
Rejects requirements for live agents
The FTC rejected proposals to add a requirement for retailers to provide a live agent to receive calls from prescribers, noting that the FCLCA does not require live agents and commenters did not provide any evidence to justify the requirement given the burden it would add on retailers.
The FTC stated: “No evidence was presented showing how often prescribers experience difficulty in obtaining reasonable access to a contact person at the seller’s company. Likewise, the Commission did not receive evidence sufficient to show that the methods for communication offered by sellers do not provide prescribers with a reasonable opportunity to communicate with the seller about the verification request.”
Rejects adoption of quantity limits
The FTC rejected proposals to adopt quantity limits on customer contact lens purchases, noting that such limits could actually harm consumer eye health by causing consumers to run out of lenses and exceed recommended wear guidelines.
The FTC stated: “[R]egardless of the evidence, or lack thereof, in the record to support the quantity limit proposals, the Commission believes that it would be difficult to administer the proposed limits, and that rather than increasing patient eye health and safety, such proposals could have the opposite effect. For example, if a consumer is running out of contact lenses and does not have time to see a prescriber promptly, there is a significant chance that the consumer will not adhere to the recommended contact lens replacement schedule and will instead try to ‘stretch out’ their lenses by re-wearing them until they can visit a prescriber. The failure to replace lenses is a well-documented cause of many contact-lens-related health issues. Absent empirical evidence that a substantial number of consumers are obtaining excessive amounts of contact lenses, or are not returning to their prescribers for eye examinations, the Commission believes that the risk of not replacing lenses outweighs the harm of consumers obtaining more lenses than strictly anticipated by the length of a contact lens prescription.”
Clarifies That Consumers Are Entitled to Additional Copies of Prescriptions
Due to the continued failure of many optometrists to provide prescriptions to consumers and alternative retailers acting as the consumers’ authorized agents, the FTC clarified the Contact Lens Rule to state that consumers are entitled to additional copies of their prescription upon request, and that alternative retailers, when designated, are also entitled to receive copies of the prescription.
The FTC stated: “[B]ecause the Commission believes that many prescribers are not providing patients with their prescriptions upon completion of their contact lens fitting, there is additional justification for ensuring that patients are able to obtain copies of their prescription when necessary. The Commission therefore believes that requiring prescribers to provide additional copies of contact lens prescriptions to patients upon request is consistent with the language and intent of the Act: providing prescription portability while protecting consumer health. Consumers with ongoing access to their prescriptions will be able to obtain the correct contact lenses from the seller of their choosing.”
UPDATE 5/2019: FTC Makes New Proposed Changes to Contact Lens Rule
In May 2019, the FTC issued a Supplemental Notice of Proposed Rulemaking, modifying its original proposal and making additional proposed changes to the Contact Lens Rule. Importantly, the updated proposal continues to require optometrists to obtain confirmation that they have released prescriptions to patients as required by law. The FTC also again rejected the AOA’s request for a weaker alternative of posting signs, which has been shown to be ineffective in protecting consumer rights.
The FTC requested public comment on its supplemental proposal, which it will consider before potentially issuing a final rule in the coming months.