Patient Safety Alliance Says FTC's New Contact Lens Rule Is 'Seen as Dangerous by Eye Doctors'

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ALEXANDRIA, Va.—The Health Care Alliance for Patient Safety (APS) on Tuesday raised concerns about the final Federal Trade Commission (FTC) Contact Lens Rule, which was issued last week, as VMAIL reported. The Alliance, in its statement, said the FTC’s final contact lens rule “fails to adequately address the dangerous practice of utilizing computer-generated voice calls to verify contact lens prescriptions and places significant burdens on doctors,” among other shortcomings cited by the Alliance for Patient Safety.

Separately, in a recent letter to ECPs, CooperVision also took issue with the FTC's updated rule, noting that it believes the FTC’s decision “leaves in place undependable robocall prescription verification techniques, adds new paperwork burdens for doctors, and addresses some concerns regarding lens substitution without closing troubling loopholes.”

“These decisions by the FTC are imprudent and of serious concern,” CooperVision’s Michele Andrews, senior director, professional and academic affairs, North America, wrote in the letter. “As evidenced by a new statement from the FTC Commissioner, the agency seemingly believes that consumer choice outweighs contact lens wearers’ health and well-being. This contradicts our conviction about your central and critical role in patient safety.”

In its response, APS said it would work with Rep. Bobby Rush (D-Ill.) and Rep. Michael C. Burgess, MD, (R-Texas) to continue pushing for passage of their Contact Lens Prescription Verification Modernization Act as a way to protect patients and reverse some of the requirements the FTC's new rule will mandate. This bill, HR 3975, has support from members of both parties, APS said.

“I am admittedly disappointed that the final [FTC] rule still allows automated recordings for prescription verification,” Rush said. “Our bill, the Contact Lens Prescription Verification Modernization Act, would correct this outrageous loophole by prohibiting automated verification calls, a practice that has no place in verifying sensitive medical information.”

The FTC vote, however, took a different view when it voted unanimously (5-0) last week in favor of its 183-page Final Rule, which amends the previous Contact Lens Rule. The FTC said the new rule will facilitate 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 its statement last week

In place since August 2004, the Contact Lens Rule imposes obligations on both eyecare prescribers and contact lens sellers. In the updated rule, as detailed in the final notice of rulemaking, 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.

The prescriber also must verify or provide the prescription to authorized third parties. The Rule 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 American Optometric Association (AOA) also has noted its fierce opposition to the FTC’s new rule and vowed to continue fighting it. "The AOA will leave no stone unturned to fight this mandate and restore sanity to contact lens care," David A. Cockrell, OD, AOA’s advocacy chair and a past president of the association, said in post on the AOA website.

The AOA will provide ECPs more information about the FTC’s changes during its upcoming #AskAOA webinar at 9:00 p.m. (ET) on Thursday, July 30. Additionally, the AOA will share a "2020 Contact Lens Rule Compliance Toolkit" in advance of this webinar that will include information about the rule, instructions on methods to comply and template materials.
In its statement Tuesday, the Alliance noted that the FTC’s ruling regarding automated calls is “seen as dangerous by eye doctors and patients who know that the continued use of antiquated prescription verification technology means incorrect prescriptions will continue to be sent to patients.”

Deanna Alexander, OD, chairwoman of the Health Care Alliance for Patient Safety, added, “APS has been working with Congress to pass legislation to remedy this ill-advised ruling on robocalls from the Federal Trade Commission. The final rule from the FTC also places significant burdens on vision doctors by requiring them to collect, maintain and store signed paperwork from a patient acknowledging receipt of their contact lenses.

“Throughout the FTC’s consideration of the proposed rule, APS suggested modern, informative and less intrusive means of communicating with patients. Unfortunately, the FTC failed to heed this guidance, instead choosing an outdated, burdensome technology,” she added.