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SILVER SPRING, Md.—The Federal Trade Commission voted 5-0 yesterday to approve 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, known as 16 CFR Part 315, 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, the FTC said in a statement.

The changes to the Contact Lens Rule, which have been debated for several years, has broad implications for consumers, contact lens makers, retailers and eyecare professionals.

“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.”

In place since August 2004, the Contact Lens Rule imposes obligations on both eyecare 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 FTC said it is issuing the Final Rule following 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. The Final Rule also incorporates changes made in response to public comments received following a supplemental notice of proposed Rulemaking published in May 2019, FTC noted.

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.

Under the new Rule, 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 American Optometric Association was quick to condemn the FTC’s decision. In a statement released yesterday, the AOA called the FTC’s decision a “discredited plan to impose a new paperwork and record-keeping... in spite of opposition from the AOA and other medical groups and bi-partisan patient health and safety leaders in Congress." The AOA also criticized the agency for making its decision “without regard to the current national public health crisis.”

“The FTC was wrong four years ago when they first proposed this destructive plan and they're wrong today in seeking to implement it,” said AOA incoming president, William T. Reynolds, OD. “More than 100 U.S. Senators and House members—Republicans and Democrats—have joined with the AOA since 2016 to fight back and we will do what it takes to increase this support going forward. This is a completely misguided attack on law-abiding frontline optometry practices that is made even more outrageous and unacceptable coming at a time when we've been providing essential, primary care to our patients through every stage of the COVID-19 public health emergency.”

The AOA said it is organizing opposition to the FTC’s “misguided action.”

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 option.

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.

In a separate, accompanying statement issued yesterday, FTC Commissioner Rebecca Kelly Slaughter suggested that Congress eliminate the word “manufacturer” from the sections of the Rule that describe the essential elements of a prescription.

“That way, most consumers could then choose the right contact lens brand or manufacturer for themselves based on price, comfort, ease of delivery, and other criteria over which sellers would compete. The majority of contact-lens consumers, who would benefit from choosing among multiple manufacturers or sellers, would then be empowered to comparison-shop without being locked into a single manufacturer by their prescriptions,” wrote Kelly.

However, she said that exceptions should be made for consumers for whom the selection of a particular brand or manufacturer on the prescription represents the prescriber’s medical judgment about the ocular health of the patient.

The Rule changes will be published in the Federal Register notice shortly and will go into effect 60 days after publication.