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ALEXANDRIA, Va.—The Health Care Alliance for Patient Safety (APS) reacted strongly this week after the Federal Trade Commission (FTC) moved to publish the new Contact Lens Rule in the Federal Register. The new CL Rule was posted for public inspection on Friday, Aug. 14 and published in the Federal Register on Monday, Aug. 17. As a result of this federal notice, the controversial changes to the CL Rule will now go into effect 60 days after the official publication date, according to APS. This would make the effective date of the requirements outlined in the new CL Rule on or about Oct. 17.

In a statement, APS said it will “urge Congress to take action to protect patients from the troubling aspects of this Rule.”

A spokeswoman told VMAIL that the FTC’s action comes “despite APS’ advocacy urging the FTC to eliminate the use of robocalls from the prescription verification process, which would have protected patient safety.” She added, “We will continue to work with Congress on a legislative fix, including supporting HR 3975, which aims to modernize the contact lens prescription verification process by eliminating the use of dangerous robocalls for the purpose of prescription verification and instead move to written forms of verification.”

As VMAIL reported, the new rule sets out certain requirements for contact lens sellers as it relates to robocalls that are incomplete or incomprehensible automated telephone messages left for prescribers. 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; and

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

In addition, the new rule calls for prescribers to do one of the following to confirm that a patient received their prescription after a contact lens fitting:

• 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 battle over the updated CL Rule has become more heated over the past few months, or since the FTC issued its update language and amendments in a statement in late June.

Subsequently, opponents to the revised rule have mobilized their efforts to have it delayed. APS said since the FTC’s final text was released, both Democratic and Republican lawmakers in both the House and Senate have taken action in “an attempt to halt the Rule’s implementation due to concerns that it could lead to adverse health outcomes for patients and overly burden doctors, especially during the ongoing pandemic,” APS chairwoman Dr. Deanna Alexander, OD, said.

She added, “The Federal Trade Commission’s publication of the Rule disregards the significant bipartisan, bicameral requests from Congress for the FTC to delay the rule. Therefore, we urge Congress to take action to protect patients from the troubling aspects of this Rule.”

Since the FTC released the final amendments to the Contact Lens Rule in June, significant Congressional action has occurred to prevent the Rule’s implementation, APS said. This includes:

• June 30: Rep. Bobby Rush (D-Ill.) and Rep. Michael C. Burgess, MD, (R-Texas) issue a statement calling for the passage of their Contact Lens Prescription Verification Modernization Act (H.R. 3975) as a legislative remedy to a portion of the FTC’s Rule.

• July 15: The House Committee on Appropriations Financial Services and General Government (FSGG) funding bill includes report language directing the FTC to delay the effective and enforcement dates of the Rule.

• Aug. 3: 94 members of the House of Representatives write to chamber leadership requesting action against the Rule in a COVID package or other legislation likely to become law soon.

• Aug. 4: 17 senators write to chamber leadership asking for their concerns regarding the Rule be addressed in COVID-19 relief legislation.

The changes to the CL Rule have been debated for several years, primarily because of the broad implications any changes would have for consumers, contact lens makers, retailers and eyecare professionals.

The old CL Rule, in place since August 2004, imposed obligations on both eyecare prescribers and contact lens sellers. The language in this rule required 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 developed the new CL 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.