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ALEXANDRIA, Va.—In an effort to offset language in the FTC’s updated Contact Lens Rule, Sen. John Boozman (R-Ark.) last week introduced in the U.S. Senate the Contact Lens Rule Modernization Act,  which would eliminate the use of robocalls to verify contact lens prescriptions, according to a statement by the Health Care Alliance for Patient Safety (APS). The bill, which APS endorsed, is co-sponsored by Sen. Roger Wicker (R-Miss.), Jim Inhofe (R-Okla.) and Sen. Rand Paul (R-Ky.). The FTC’s new rule for contact lenses and the corresponding requirements for ECPs is set to take effect Oct. 17.

In addition to eliminating the use of robocalls to verify CL prescriptions, the bill removes burdensome paperwork requirements for patients and providers, instead giving eyecare practices the ability to notify patients of key rights regarding their contact lens prescriptions through methods like in-office signage that have been adopted in California, according to the APS statement.

APS has long advocated for these important changes to the Contact Lens Rule, “often with the support of members of Congress on both sides of the aisle,” the statement noted.

Several issues related to contact lens prescription verification and ODs’ record-keeping requirements for CL patients have become a hot-button issue for ECPs since the FTC introduced its updated contact lens rule in June, and which VMAIL reported on here.

The FTC’s the new rule does set out certain requirements for contact lens sellers as it relates to robocalls. The new rule requires sellers who use automated telephone messages for verification to:

• 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.

• Make the message repeatable at the prescriber’s option.

The Contact Lens Rule was “originally written with the intent of increasing patient access to contact lens prescriptions while promoting patient safety,” APS noted in its statement last week. “APS supports these goals of the Rule, but has voiced concern that the passive verification provision—often exploited by certain sellers through the use of robocalls—can jeopardize patients’ vision health.”

The Contact Lens Rule Modernization Act would protect patients by requiring sellers of contact lenses to use either written electronic communication or a live phone call to properly verify a prescription, according to APS. Multiple studies show the use of nonprescribed and unverified contact lenses—Class II or Class III medical devices—can result in serious and potentially blinding eye health events, including keratitis, corneal scarring, corneal ulcers, and infection.

In addition, the bill would eliminate the burden of collecting and maintaining paperwork from patient —the so-called signed acknowledgement form—and instead alert them to their patient rights via written notifications placed within the prescriber’s clinic. The use of signage and other notifications is a standard implemented in California, where patient safety advocates find the measure informative and nonintrusive, according to APS.

“The FTC may have had good intentions when it wrote this rule, but the bottom line is it puts patient safety at risk and creates undue burdens on small health practices,” Sen. Boozman said. “It simply misses the mark. The Contact Lens Rule Modernization Act will address the shortfalls in the FTC rule. It alleviates patient safety concerns by banning automated prescription verification calls and removes unnecessary requirements the rule placed on providers who are already facing new challenges as a result of COVID-19.”

Deanna Alexander, OD, chairwoman of the Health Care Alliance for Patient Safety, added, “The introduction of the Contact Lens Rule Modernization Act is yet another indication that Congress has heard the concerns of patient safety advocates and is intent on acting to safeguard contact lens-wearing patients. Embracing modern technology for Class II or Class III medical device prescriptions will strengthen the doctor-patient relationship and protect patient safety, making the Contact Lens Rule Modernization Act a commonsense solution that can garner broad, bipartisan support.”