Patient Safety Advocates Applaud the Introduction of the Contact Lens Rule Modernization Act in the U.S. Senate

The Health Care Alliance for Patient Safety (APS) today applauded the introduction of the Contact Lens Rule Modernization Act by Sen. John Boozman (R-AR) in the United States Senate. Specifically, the bill, which is co-sponsored by Sen. Roger Wicker (R-MS), Jim Inhofe (R-OK) and Sen. Rand Paul (R-KY), protects patient eye health by eliminating the use of robocalls to verify contact lens prescriptions. The bill also removes burdensome paperwork requirements for patients and providers, instead giving eye care 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. 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 Contact Lens Rule was originally written with the intent of increasing patient access to contact lens prescriptions while promoting patient safety. 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. 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 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.

“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. 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,” Sen. John Boozman said.    

“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,” said Dr. Deanna Alexander, O.D., chairwoman of the Health Care Alliance for Patient Safety. “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.”

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. Since the FTC released the final amendments to the Contact Lens Rule in June, APS has advocated for these important measures to keep patients safe. This latest effort from Senator Boozman provides a legislative fix to a pair of issues that have not been addressed through regulation.

June 23, 2020:                  FTC 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        Sen. John Boozman introduces the Contact Lens Rule Modernization Act with co-sponsors Sen. Roger Wicker, Sen. Jim Inhofe and Sen. Rand Paul to modernize the contact lens prescription verification process and eliminate the burdensome signed acknowledgement form requirement.

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About APS


The Health Care Alliance for Patient Safety, founded in 2018, advocates for eye health and safety and elevates the doctor-patient relationship – the essential foundation of personal health care decision making. Members of the Alliance for Patient Safety work together to raise awareness and protect public health. Advancing policy and collaboration between leading eye health advocates, vision innovators and trusted voices is essential to elevate patient care.

The Alliance is made up of patient safety advocates, eye doctors, contact lens manufacturers and insurers.

To become a local advocate or to get involved in protecting patient safety, visit www.patientsafetytoday.com.