16 CFR Part 315; Agency Information Collection Activities: Review; Comment Request; Contact Lens Rule: FTC Project No. R511995
1. There is a continued need for the Contact Lens Rule to benefit consumers, so I believe the rule should remain in effect. 2. The manner by which a contact lens prescription may be verified should be changed. Sellers of contact lenses should be required to receive direct verification from the prescriber of a consumer's contact lens prescription before filling it, if the consumer does not provide the seller with a written or electronic copy of his/her contact lens prescription. Currently, sellers are using what is called "passive verification" to verify contact lens prescriptions for consumers where an automated system calls a prescriber's office and starts speaking the details of the consumer's contact lens prescription and other personal information to the person answering the phone. I believe this practice to be in direct violation of the Health Insurance Portability and Accountability Act (HIPAA). There is no guarantee that the person answering the phone is in fact the prescriber (or one of his/her staff members covered under HIPAA) or if the seller is contacting the correct prescriber. Therefore, consumers personal and medical information is currently being transmitted unsecured to a third party by using an automated phone verification system. If there is no response within 8 business hours of the message from the automated phone system from a prescriber, the contact lens prescription is filled and dispensed to the consumer as is, even though it was never actually verified by anyone. Many consumers are being given incorrect contact lenses because sellers are not currently required under the Contact Lens Rule to directly verify (either by fax or other means) contact lens prescriptions. Sellers should be required under the rule to contact the prescriber using his/her preferred method of contact, like by phone, fax, or email. One of the biggest online sellers of contact lenses uses phone calls to passively verify contact lens prescriptions and can take up to 2-4 minutes per prescription in order for the automated system to complete the verification call. If the call is disconnected or stopped for any reason, the automated system continues to call back until the phone message is heard in its entirety. During peak times, many prescribers and staff members do not have 2-4 minutes to verify a contact lens prescription at that particular time since they may not have the consumer's record in front of them at the time of the call. It would be best if sellers were required to contact prescribers by other means (other than an automated phone message) as previously mentioned and be able to respond in a more effective manner. 3. Contact lenses are class 2 medical devices regulated by the FDA and FTC and require a prescription in order to be sold. Sellers of contact lenses are currently not required to have any education, qualifications or certifications to fill or dispense contact lens prescriptions in the majority of states to consumers. In order to ensure consumer safety, people filling and dispensing contact lens prescriptions to consumers should be required to obtain a certification in contact lenses. The national standard for contact lens certification is the National Contact Lens Examiners (NCLE) organization. This certification can be obtained after completing a formal college course in contact lenses, a home study, an independent study or by other means such as on-the-job training. Requiring sellers to be certified in contact lenses would ensure better consumer safety.