June 25, 2020
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FTC adds requirements for contact lens prescription release

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The Federal Trade Commission announced in a June 23 press release that updates to the Contact Lens Rule will now mandate that doctors who prescribe contact lenses must maintain proof that they released the prescription to the patient for at least 3 years.

In addition, those who sell contact lenses will now be required to deliver automated phone messages slowly, deliberately and loudly.

The Contact Lens Rule, in effect since August 2004, imposes obligations on both prescribers and sellers. According to the rule, prescribers are required to provide patients with copies of their contact lens prescriptions after a fitting and must also verify or provide the prescription to authorized third parties. Vendors are required to sell contact lenses only in accordance with the prescription or verification received from the patient or prescriber.

Nuances of the rule’s requirements have been debated over the years by representatives of both doctors and vendors. The FTC said in its press release that it has received and considered thousands of public comments between 2015 and 2019.

According to the new final rule, doctors are required keep on file for 3 years one of the following: a patient-signed confirmation statement, copy of the prescription or sales receipt for the exam confirming the patient received the prescription or proof that the patient received a digital copy of the prescription. Prescribers are also required to provide an additional copy of the prescription to the patient or “designated agent” within 40 business hours.

The American Optometric Association declared its opposition to the ruling, specifically the new paperwork and record-keeping mandate.

The group said in a press release that it and other medical groups and bipartisan patient health and safety leaders in Congress have fought the concept of securing and storing contact lens prescription release acknowledgment forms that the FTC has sought for 4 years.

“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,” incoming AOA President William T. Reynolds, OD, said in a press release.

Additional requirements for sellers address the concern that automated phone messages made to doctors’ offices for prescription verification are difficult or impossible to understand. Now, sellers who use these “robocalls” are required to record the call and save it; begin the call by saying it is a “prescription verification request made in accordance with the Contact Lens Rule;” deliver the message slowly, deliberately and at a suitable volume; and make the message repeatable.

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The FTC also intends to reduce illegal prescription alterations by requiring that sellers facilitate a method for consumers to present their prescriptions. In addition, sellers are prohibited from substituting a brand or manufacturer except in a situation where private label and brand-name lenses are identical and made by the same manufacturer.

The commission approved this rule unanimously.

FTC commissioner Rebecca Kelly Slaughter issued a separate statement, which said, “I write to candidly observe an anticompetitive dynamic in the contact lens market in the U.S. that cannot be fixed within the bounds of our rulemaking authority under the current act.”

Slaughter asked Congress for legislation to “further empower consumers and promote competition among contact lens sellers.”

Slaughter suggested the removal of the word “manufacturer” from the rule.

“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,” Slaughter wrote. “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.”

The FTC said in its release that the final notice will be published shortly in the Federal Register and then go into effect 60 days later.