Contact lens prescription verification failings targeted by new legislation

May 20, 2021
The AOA-backed bill recently introduced in Congress would close some egregious loopholes in the problematic verification process, such as automated “robocalls.”
Robocalls

A porous, problematic contact lens prescription verification system currently falls short of its intended design, but new legislation before Congress seeks to empower patients while restoring commonsense health and safety protections.

Introduced May 19 in the U.S. House by Reps. Bobby Rush, D-Ill., Lisa Blunt Rochester, D-Del., Michael Burgess, M.D., R-Texas, David McKinley, R-W.Va., and May 20 in the U.S. Senate by Sens. Tammy Duckworth, D-Ill., and John Boozman, O.D., R-Ark., H.R. 3353/S.1784, the Contact Lens Prescription Verification Modernization Act, would help make the contact lens prescription verification process simpler and safer for millions of Americans. In a joint statement, the members of Congress echoed the need to overhaul the faulty verification system and ensure proper oversight and protections are restored for American contact lens wearers. H.R. 3353 was referred to the House Energy and Commerce Committee.

“It is time to fix the robocall, loophole, unscrupulous, internet-based mass contact lens retailers continue to exploit, undermining quality care and needlessly putting patient health at risk,” says William T. Reynolds, O.D., AOA president. “The AOA, doctors of optometry and the patients they serve in communities across the country thank Reps. Rush, Burgess, Rochester and McKinley for their visionary leadership in introducing this bill and for their demonstrated dedication to improving the health and safety of millions of contact lens-wearing Americans.”

Jointly backed by the AOA and the Health Care Alliance for Patient Safety (APS), the bipartisan H.R. 3353/S. 1784 would prohibit prescription verification via automated robocalls and establish a paper trail by requiring online sellers to use direct communication, e.g., email, live phone calls or fax, to confirm prescription accuracy. Further, the bill requires online sellers to offer a HIPAA-compliant method for allowing patients to upload an electronic copy of their prescription thereby deprioritizing the use of verification robocalls.

“The Contact Lens Prescription Verification Modernization Act offers a commonsense solution to close a critical loophole in the prescription verification process by ensuring patients receive the exact contact lenses they were prescribed by their doctor,” says APS Chair David Cockrell, O.D., in a news release. “The current, antiquated system of verifying contact lens prescriptions too often relies on outdated robocalls, which burden doctor offices and put patient eye health at risk. The Alliance thanks Reps. Rush and Burgess, Blunt Rochester, and McKinley for reintroducing this bill in the 117th Congress. We applaud their strong commitment to protecting patient eye health.”

Previously introduced in late 2020, the bill quickly garnered 74 cosponsors after an historic response with over 7,400 individual constituent letters sent via AOA’s Action Center before the Congressional session closed. Now, reintroduction of H.R. 3353/S. 1784 coincides with the AOA’s single-largest, annual, federal advocacy event, Virtual AOA on Capitol Hill, May 23-25, where hundreds from within the profession will advocate for key legislation and issues immediately affecting optometry.

Closing the regulatory loopholes

Popular with roughly 45 million Americans, contact lenses are a safe and effective vision-correction option when worn and cared for properly. However, poor-fitting or improperly used contact lenses can result in serious eye and vision harm, which is why the U.S. Food and Drug Administration (FDA) regulates contact lenses as Class II and III medical devices that require an eye doctor’s prescription and oversight. Both the FDA and Centers for Disease Control and Prevention (CDC) advise consumers that contact lenses are not “one size fits all” and that regular comprehensive eye examinations are necessary for ensuring optimal eye health.

Despite these health and safety concerns, online contact lens sellers not only permit consumers to purchase these medical devices using expired prescriptions but also sell altogether different brands or types of contact lenses than were prescribed by their doctor. Although these kinds of practices are outlawed by the Fairness to Contact Lens Consumers Act (FCLCA) and Contact Lens Rule, online sellers commonly exploit loopholes in the current verification process to bypass FTC enforcement. One such loophole often employed by online contact lens sellers are automated robocalls.

While the FCLCA clearly allows telephone, fax or email for verifying prescriptions, the FTC has interpreted the law to permit robocalls as well. Commonly, these automated calls to eye care providers are difficult to understand; do not include all the necessary information for confirmation; and create barriers for doctors to communicate back the necessary prescription corrections. In some cases, doctors are unable to immediately provide critical health and safety feedback if a request is being made for an incorrect device or for an individual who is not a patient of the doctor.

Some online sellers also use robocalls to take advantage of the current “passive verification” provision of the FCLCA and Contact Lens Rule that doctors have only an 8-hour window to respond before a prescription is automatically verified. By exploiting such loopholes, online sellers push products not prescribed by the patient’s eye doctor.

In fact, a June 2020 report from the AOA Health Policy Institute found that among doctors of optometry who provide contact lens services:

  • 89% received prescription verification calls for invalid prescriptions.
  • 54% received prescription verification calls for an altogether wrong prescription.
  • 43% received prescription verification calls for someone who wasn’t their patient.

 Considering millions of contact lens wearers purchase their lenses through internet mass retailers, this is a problem that the AOA, eye care providers, industry stakeholders and patient safety groups continue to broach with legislators and regulatory authorities.

During a 2018 FTC panel discussion on the Contact Lens Rule and the prescription verification process, Dr. Cockrell noted that the current verification process is flawed, explaining that if he had issues with a medical prescription filled by a pharmacy, he could simply call and question the issuer. In the case of contact lenses, sellers’ unintelligible automated calls do not support two-way communication between the eye care provider and seller.

“The verification process, as it stands right now, is ineffective and maybe the politest way is to say it doesn’t work—it’s a one-way system,” Dr. Cockrell said, noting it is a widespread problem for all eye care providers nationwide.

Added fellow panelist Tim Steinemann, M.D.: “These are not live calls. These are robocalls. Many of those robocalls are unintelligible or cut off, and we have no way of responding or even verifying the information. So, I agree with Dr. Cockrell, the verification framework is insufficient. It doesn’t work and it’s not properly enforced.”

Although these concerns were vocalized through repeated comment periods; bipartisan Congressional letters, panels and direction; and the public workshop to discuss the 10-year review of the FTC’s Contact Lens Rule, federal regulators chose instead to impose new requirements on prescribers while only modestly addressing sellers’ troublesome robocalls.

Support optometry’s advocates

The AOA urges the profession’s support of this priority legislation to help close problematic loopholes commonly exploited by online contact lens retailers. Here’s how you can act now:

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