Patient Safety Advocates Encouraged by Contact Lens Rule Modernization Act’s Scheduled Markup in the U.S. Senate

The Health Care Alliance for Patient Safety (APS) today applauded the U.S. Senate Committee on Commerce, Science and Transportation, Chairman Roger Wicker (R-MS) and Ranking Member Maria Cantwell (D-WA) for scheduling the markup of the Contact Lens Rule Modernization Act (S.4613). The markup will take place on Wednesday, November 18, 2020.

The bill, which has bipartisan support, protects patients by requiring sellers of contact lenses to use either written electronic communication or a live phone call to properly verify a contact lens prescription. Currently, sellers most commonly use robocalls to verify contact lens prescriptions, a practice that can lead to patients receiving lenses other than those prescribed by their eye care provider. 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 patients — the so-called signed acknowledgement form — and instead alert them to their patient rights via written notifications placed within prescribers’ clinics. The use of signage and other notifications is a standard implemented in California, where patient safety advocates find the measure informative and nonintrusive.

“Since the Federal Trade Commission (FTC) announced the final Contact Lens Rule in June, Members of Congress from both parties and patient safety advocates from across the country have called for action to modernize the Rule to ensure prescription accuracy and better-inform patients of their rights,” said Dr. Deanna Alexander, O.D., chairwoman of the Health Care Alliance for Patient Safety. “We appreciate the Committee’s attention to this critically important bill, which would improve patient protections for millions of contact lens-wearing patients in this country.”

Members of Congress on both sides of the aisle and in both chambers have gone on the record calling for changes to how contact lens prescriptions are verified and how patients are notified of their prescription rights. APS has consistently advocated for these important measures to keep patients safe, including through advocacy with the FTC and Congress. This bill’s inclusion in the November 18th markup signifies an important next step in patient safety advocates’ effort to secure a legislative fix to a pair of issues that have not been addressed through regulation. Past action from Members of Congress include:

June 23, 2020:                  FTC announces final amendments to the Contact Lens Rule

June 30, 2020:                  Rep. Bobby Rush (D-IL) and Rep. Michael C. Burgess, M.D. (R-TX) 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, 2020:                    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

August 3, 2020:                Ninety-four Members of the U.S. House of Representatives write to chamber leadership requesting action against the Rule in a COVID package or other legislation likely to become law soon  

August 4, 2020:                Seventeen United States Senators write to chamber leadership asking for their concerns regarding the Rule be addressed in COVID-19 relief legislation

September 17, 2020        The Contact Lens Rule Modernization Act is introduced to modernize the contact lens prescription verification process and eliminate the burdensome signed acknowledgement form requirement.

November 18, 2020        The U.S. Senate Committee on Commerce, Science and Transportation to markup the bipartisan Contact Lens Rule Modernization Act.