Contact Lens Rule revisions aren’t enough, AOA addresses deficiencies

Optometry's advocates acted swiftly to ensure patient safety concerns and superfluous burdens on prescribers aren't dismissed out of hand with supplementary changes to the Federal Trade Commission's (FTC's) proposed Contact Lens Rule.

Released on May 2, the FTC's notice of supplementary rulemaking reaffirmed its initial recommendation to require that contact lens prescribers obtain a signed prescription acknowledgement receipt from each contact lens patient and conceded few points that the AOA and patient safety advocates have repeatedly emphasized since proposed changes to the Contact Lens Rule first published in November 2016.

Among those points, the AOA continues to decry the baseless administrative mandate levied on prescribers while doing nothing more to curb internet retailers' documented violations of the very patient health and safety laws that the regulatory rule review seeks to update. However, the FTC's decision to publish supplementary rulemaking and adjust the commission's initial Contact Lens Rule proposal after nearly three years of review suggests the profession's advocacy is having an effect.

"The new proposed rule includes recommendations that are direct results of our hard work; however, these changes fall short of what is needed to protect patients and we will persevere," said AOA Immediate Past President Samuel D. Pierce, O.D. "The power of AOA advocacy, when buoyed by the strength of all doctors of optometry speaking with the same voice, is evidence in the FTC's recent revisions."

Stepped up pressure

Even before the FTC's 60-day public comment period for supplementary rulemaking closed on July 29—registering nearly 900 formal comments—AOA member doctors, students and other advocates spoke out with authority against the proposal. The AOA's Online Legislative Action Center alone noted thousands of emails and letters, in addition to countless phone calls, urging a Congressional response to the FTC.

In all, nearly 25 U.S. senators signed letters urging the FTC not to finalize its latest proposal. Led by Sens. James Lankford, R-Okla., and Krysten Sinema, D-Ariz., the bipartisan effort underscored the need for improved enforcement of existing Fairness to Contact Lens Consumer Act (FCLCA) patient health safeguards and called into question the necessity of a paperwork mandate.

"According to the FTC's own data, few complaints regarding prescription release have been received and the Commission estimates that this new mandate would add millions in new regulatory compliance costs," the letter reads. Additionally, Sens. Ron Wyden, D-Ore., and John Barrasso, R-Wyo., penned stand-alone letters, while Sens. Jack Reed, D-R.I., and Sheldon Whitehouse, D-R.I., jointly petitioned the FTC.

The latest wave of Congressional support comes nearly a year to the day that more than 100 U.S. Senate and House leaders signed on to a similar push by Reps. Bobby Rush, D-Ill., and Michael Burgess, M.D., R-Texas, that helped halt the FTC's initial proposal from being finalized.

Concurrently, more than 600 doctors of optometry responded to the AOA's urgent appeal for information in the form of a practice survey. These responses, as well as 1,028 unique complaints logged with AOA concerning illegal contact lens sales practices between 2017 and 2019, and nearly two dozen de-identified patient case reports of harm resulting from adverse events, added valuable weight to the AOA's case concerning egregious loopholes in the current prescription verification process and resulting patient harm from inappropriately procured contact lenses.

In a 46-page, point-by-point response to the supplementary rulemaking public comment period, the AOA highlighted discrepancies, misleading proprietary data from 1-800 Contacts and outright contradictions cited by the FTC in support of its prescription paperwork mandate. Additionally, the AOA reiterated an alternative, less burdensome signage proposal, addressed questions concerning contact lens substitutions and the abused "passive verification" prescription verification provision.

Takeaways from FTC's supplementary rulemaking

1. The AOA remains concerned with any FTC requirements that create an additional burden on doctors and their patients. Any additional regulatory requirement on physicians flies in the face of the current administration's effort to address regulatory excess in health care. The AOA has raised these concerns at the highest levels in the executive branch and will continue to do so. The AOA also will continue working to enlist the even more than 100 senators and House members who have already joined the AOA in urging the FTC to withdraw its burdensome requirements and to target illegal contact lens sales and other anti-patient abuses. 
   
   
2. The FTC's initial proposed rule in 2016 included no additional requirements for contact lens retailers. Since then, the AOA has consistently reported dozens of contact lens retailers with dangerous business practices to the FTC. As a result, the May 2019 proposal would impose new requirements on contact lens retailers. The FTC notes these changes are intended to address, in large part, the companies that sell their own brand of lenses, which the AOA has repeatedly reported to the FTC.  The FTC noted, "the Commission is aware that more sellers have been entering the market to sell their own brands of lenses directly to consumers, and this, along with a large number of complaints and anecdotal reports of instances of alteration by online sellers—some of which describe vision-threatening injuries—necessitate modifications to the Rule." The FTC also made clear, "any attempt to substitute another lens, including a seller's own brand, for the prescribed lens thwarts the purpose of the Act, which is to allow sellers to sell contact lenses as prescribed by the consumer's eye-care provider." While the FTC must do more to ensure safety in the market, the updated proposal takes aim at true and widespread contact lens retailer issues that the Commission was previously unwilling to act on.
   
   
3. The FTC also has proposed to implement new requirements for robocalls. The FTC indicated, "Concerns about passive verification resulting in patients receiving contact lenses for which they have no prescription are not new and were considered when Congress passed the Fairness to Contact Lens Consumers Act and in the Notice of Proposed Rulemaking in 2016. What is new, however, is the emergence of business models that rely almost exclusively on passive verification as a means to substitute their own brand of daily contact lenses." While the AOA appreciates that the Commission has finally acknowledged how these calls are being used to subvert verification rules, it remains opposed to the use of robocalls to confirm contact lens prescriptions. That is why the AOA will continue to build support for the Contact Lens Prescription Verification Modernization Act. Doctors can to reach out to members of Congress in support of this bill. 
   
   
4. The typical rulemaking process involves a proposed rule followed by a public comment period and then a final rule. For this rulemaking, there has been a proposed rule, a public workshop and now supplementary rulemaking with a comment period. It's clearoptometry does not back down when patients are being put at risk.

The May 2, 2019, proposals put forward by the FTC are not final. As it has done over the past two and a half years, the AOA will continue to fight for doctors and their patients.