Update: Legislation targets prescription verification, deceptive internet sales tactics
New patient safety requirements and increased accountability for the internet contact lens sales industry are key elements of bipartisan, bicameral bills to curb abuses of the Fairness to Contact Lens Consumers Act (FCLCA).
Introduced by Reps. Pete Olson (R - TX) and Kathy Castor (D - FL) on Sept. 22, H.R. 6157 seeks to modernize the prescription verification process for contact lenses and clarify consumer protections regarding their false advertising. This bill complements S. 2777, the Contact Lens Consumer Health Protection Act of 2016, introduced April 11 by Sen. Bill Cassidy, M.D., (R - LA)—legislation that originally earned AOA's support to crack down on an array of internet sellers' schemes that deceive the public, risk patient health and add to health care costs.
"This bill will give contact lens wearers peace of mind, protecting them from dishonest online sellers whose unscrupulous tactics can cause patient harm and increase health care costs," says Andrea P. Thau, O.D., AOA president. "The AOA commends Reps. Olson and Castor for their bipartisan leadership in making patient safety a top priority."
The AOA-backed H.R. 6157 and S. 2777 focus on strengthening the patient health safeguards of the FCLCA that have been undermined, and in certain cases even ignored, by unscrupulous internet contact lens sellers.
These bills offer commonsense, pro-patient approaches based on the importance of contact lenses as medical devices, including:
- Hold sellers accountable for illegal sales tactics and false claims, and make increased enforcement to safeguard public health a priority for the Federal Trade Commission.
- Establish a live patient-safety hotline allowing doctors to provide sellers with patient health information and ensuring that the doctor-patient relationship is respected.
- Ban use by internet sellers of disruptive automated “robocalls” into doctors’ offices as the mechanism for verifying patient prescription information, and allowing doctors to choose live phone calls or emails from sellers instead.
- Ensure contact lenses must be dispensed exactly as the prescription is written by the doctor.
- Direct the Centers for Disease Control and Prevention to study the public health and health care cost impact of internet seller abuses.
- Increase fines to sellers to $40,000 per infraction.
"This bill not only ensures stronger safeguards for patients, but it also sends a message to sellers that illegal tactics and false claims that put patient health at risk will not be permitted," says Congressman Olson. "I'm encouraged by the support for this bill and look forward to working with Rep. Castor and Sen. Cassidy toward passage on behalf of contact lens patients nationwide."
Congresswoman Castor adds: "This bill puts patients first and keeps intact the patient-doctor relationship, which is a critical component of our health care system. Rep. Olson and I are proud to introduce this bipartisan legislation, which puts measures in place that ensure doctors can verify important information to further safeguard patients' eye health."
Following introduction of S. 2777 earlier this year, AOA Immediate Past President Steven A. Loomis, O.D., said AOA was proud to support the bill and promised that AOA will continue working to make patient safety the priority it needs to be on Capitol Hill. In a news release, Sen. Cassidy said: "As a physician, I value patient safety, and our eye health professionals need the ability to act as good stewards of patient health, as the original FCLCA intended."
"Safeguards like those in the FCLCA should be strengthened to preserve access to accurate information and the contact lenses patients need," Sen. Cassidy continues. "The Contact Lens Consumer Health Protection Act of 2016 will provide patients with these stronger safeguards, and will modernize the way our contact lens marketplace is able to work. I appreciate the commitment of the Optometric Association of Louisiana, the American Optometric Association, and the broader coalition to protecting patients' eye health; I look forward to working together to ensure the FTC takes into account public health as it reviews the FCLCA."
Legislation such as H.R. 6157 and S. 2777 help establish effective measures that make goals outlined in a newly released National Academies of Sciences, Engineering and Medicine report that much more obtainable in improving vision health in America.
Efforts to reign back online sellers' unscrupulous tactics
Despite the fact that contact lenses are U.S. Food and Drug Administration (FDA)-regulated medical devices that require a valid prescription from a patient's doctor, some internet-based sellers employ tactics that sidestep federal law designed to keep contact lens wearers safe, and AOA continues to call attention to such violations.
Complaints from doctors of optometry, other eye care professionals and consumers have raised concern that some internet sellers do not properly verify prescriptions, overfill orders, fill expired prescriptions or fill orders with lenses other than those that were prescribed, placing patients needlessly at risk.
A 2015 Johnson & Johnson Vision Care consumer survey found that among contact lens patients who ordered their lenses online:
- 1 in 4 reported receiving a different contact lens brand than prescribed by their doctor without advanced warning;
- 1 in 3 reported an online retailer advised them to substitute a nonprescribed lens due to supply issues; and,
- 1 in 3 reported they purchased contact lenses with an already expired prescription.
These tactics are not new and aren't going unnoticed. This year, one of the largest online contact lens retailers, 1-800 Contacts, was sued by the FTC over efforts to stifle competition and increase prices. The suit alleges that the company unlawfully used its market power to orchestrate and maintain anti-consumer agreements with rival online contact lens retailers.
"The Federal Trade Commission just filed suit against one of the larger online contact lens vendors saying basically that they colluded with others to raise the price for consumers," Sen. Cassidy noted in a recent interview.
"The eye doctors have pointed out that they're supposed to verify the eye prescription, but some of the firms are just shipping it out. So we're trying to preserve the ease and access of online, but make sure there isn't this collusion that is illegally raising prices for consumers and also making sure they get their eye health taken (care of)."
This past year, AOA also has alerted federal officials of questionable business practices of online contact lens sellers, such as 1-800 Contacts' pre-checked authorization box used to "deceptively" assert the right to act as the patient's agent and failing to effectively communicate the need for physician oversight when using contact lenses.
Additionally, AOA submitted detailed formal comments on the FTC Contact Lens Rule—now under a once-per-decade review—in October 2015. In doing so, AOA is backing reforms to make patient health and safety the highest priority, including by fixing the broken passive verification system, stopping contact lens sellers' misleading marketing ploys and ensuring sellers make available a live-contact person for doctors to discuss prescription issues.
Congressional conference discusses protecting contact lens patients
These regulatory and advocacy efforts, coupled with S. 2777, factor heavily into this year's special health policy listening session at AOA's Congressional Advocacy Conference, April 17-19, in Washington, D.C.
Titled, "Patient Vision Care Safety: Enforcement on Federal Contact Lens Patient Health Laws," the listening session updated lawmakers on how unscrupulous internet sellers threaten the eye health of patients, urging their support for stronger enforcement, as well as broaching the use of telehealth expansion.
Read more about this health policy listening session in a July/August 2016 AOA Focus feature, titled, "Hoops, Loops and Listening Groups: Patient Vision Safety and the Contact Lens Marketplace."
Online contact lens retailer, Vision Direct UK, to halt sales without required prescriptions after AOA complaints
After years of the AOA alerting the company of regulatory and legal requirements regarding contact lens sales, Vision Direct recently announced on its website that it was halting its no-prescription service.
The advocacy collaborative fighting for patient safety and the doctor-patient relationship reports on a productive 2020, despite COVID-19 challenges, and recently welcomed Alcon as its newest member.
At Nov. 17 FDA workshop, doctors of optometry warn of a lack of communication regarding the safety of online vision tests. The AOA, which continues to educate the public on these mobile apps and to hold them accountable, offers its expertise.