Verification of Contact Lens Prescriptions
The Contact Lens Rule (CLR) was implemented in 2004 to promote competition in the contact lens market. It enables “consumers” (i.e., wearers) to shop around, and it permits passive verification of prescriptions: Under the CLR, if a vendor contacts a prescriber’s office to verify a prescription but doesn’t hear back within eight business hours, the prescription is considered to be automatically verified.
How big a problem is passive verification of prescriptions? We explored the rate of invalid prescriptions presented for passive verification at a county hospital and a private office—and we found a rate of 52.8%.1 Many of these patients had not seen an eye care provider in years but were still able to order nonprescribed, unvetted contact lenses, putting them at risk for lapses in education and increased risk of complications.
In June 2020, addendums were announced to address some of the CLR’s problems. Unfortunately, many problems were not addressed, including the use of automated phone calls to verify prescriptions. Under the new requirements, the Federal Trade Commission (FTC) calls for sellers to take additional measures to ensure automated calls are comprehensible to the prescriber, but it does not ban the use of automated calls. Another problem is that the FTC now mandates providers to “prove” that prescriptions are released to patients—a response to a problem that may not widely exist.
The passive verification loophole is still in desperate need of revision. Patients are responsible for purchasing lenses that are FDA-approved with a prescription that is current, specific, and valid. This is unlikely to happen within the current eight-hour window constraint of passive verification. Caveat emptor.
Contact lenses are FDA-sanctioned medical devices, but they are increasingly sold as a “product” to “consumers.” As ophthalmologists, we should resist the marketing trend to treat contact lenses as interchangeable commodities.
Renato J. Yupari, BS
Thomas L. Steinemann, MD
Case Western Reserve University School of Medicine
1 Yupari RJ, Steinemann TL. Eye Contact Lens. 2020;46(4):197-200.
For more on the CLR, see this month’s D.C. Report.