The Contact Lens Rule, in effect since 2004, imposes obligations on both prescribers and sellers of contact lenses. By all measures, we have complied admirably, with very few complaints made to the Federal Trade Commission (FTC). Unfortunately, the same can’t be said about sellers, whose passive verification efforts are riddled with abuses. And now the final, amended Contact Lens Rule tips the scales further against prescribers and our patients. What on earth is the FTC thinking?
Hit Us With More Paperwork...
Instead of zeroing in on the seller’s blatant infractions and disregard for the Rule’s objectives, the FTC chose to place additional burdens on prescribers, requiring us to release all prescriptions and maintain documentation for three years. Unfortunately, the Final Rule does a poor job at modernizing the prescription verification process, especially the irksome computer-generated robocalls.1
The Final Rule’s new hassles are made even more stressful by the COVID-19 pandemic. The cost of these new measures is estimated at $18,000/year for every practice. This could easily be addressed through more modern and less intrusive means.1
The House Financial Services and General Government Subcommittee inserted language admonishing the FTC and directed the commission to delay implementation.1 If it goes forward in October as planned, the FTC amendment gives us five options for documenting Rx release:
- Ask the patient to acknowledge their receipt of the contact lens Rx by signing a separate document.
- Ask them to instead acknowledge this by signing a copy of the Rx that contains a statement confirming the patient received it.
- Add a statement about Rx release to the sales receipt for the exam and ask the patient to sign a copy.
- Provide the patient with a digital copy of the Rx in a way that is verifiable after the fact.
In addition, patients can request an additional copy of their prescriptions for within 40 business hours.
…And Let Sellers Slide
The Final Rule, although “prohibiting prescription alteration,” includes modifications designed to purportedly reduce illegal sales by sellers. It allows substitution for private label lens prescriptions “when they are identical lenses made by the same manufacturer.”2 This modification is extremely troubling in light of the push by some sellers to make all prescriptions suitable for substitution with a generic version, if they so desire. It appears that we’re only a small step away from that debacle.
Secondly, by not addressing the abuses that take place due to passive verification, the FTC has placed retail over health and safety. The FTC has definitely missed an opportunity to address safety concerns. There is a high rate of invalid prescriptions presented for passive verification.
More than half (52.8%) of all passive verification fax requests in a recent study were found to be invalid.3 The majority of the prescriptions were expired, some contained incorrect specifications or no record of prescription by the provider. The authors concluded, “the current mechanism of passive verification, with the burden on the provider for denial within a short time window, makes it likely that such prescriptions would be filled, potentially putting patient comfort and safety at risk.”3
Should you witness any retailer’s abuses, please report them to: www.aoa.org/stopillegalcls. We need to support legislation (HR 3975) in Congress that addresses robocall abuses.
If I had the opportunity, I would ask the FTC bureaucrats: (1) why the imposition and additional encumbrance and (2) why now, when we’re struggling to deal with the ravages to our practices placed upon us by the COVID-19 pandemic? The last thing we need is additional paperwork as things just begin to get back to near-normal.
Where do we go from here? If you’re not happy and feel you want to continue the cause, write to your legislators now. A special thank you to the American Optometric Association, the Health Care Alliance for Patient Safety, the manufacturers who responded to date and all the rest of the folks who worked tirelessly to stop this unnecessary burden. Regardless of the final outcome, they should be acknowledged for their tenacious effort to halt the Final Rule.
1. American Optometric Association. Action Changes Things. July 2020.
2. Federal Trade Commission. FTC Announces Final Amendments to the Agency’s Contact Lens Rule. www.ftc.gov/news-events/press-releases/2020/06/ftc-announces-final-amendments-agencys-contact-lens-rule. June 23, 2020. Accessed July 30, 2020.
3. Yupari RJ, Steinemann TL: Passive verification: A flawed system putting patient’s sight at risk. Eye Contact Lens. 2020;46(4):197-200.