16 CFR Part 315; Agency Information Collection Activities: Review; Comment Request; Contact Lens Rule: FTC Project No. R511995 #00134

Submission Number:
Michael Ciszek
Initiative Name:
16 CFR Part 315; Agency Information Collection Activities: Review; Comment Request; Contact Lens Rule: FTC Project No. R511995
The Contact Lens Rule is good in concept but is awful in its current application. Patients routinely state that they have been ordering lenses for years without having a prescription. They seem surprised when we mention that they require a yearly examination and updated prescription. Some of these patients are actively trying to beat the system. Other patients simply do not know that any rules or regulations exist about the selling of contact lenses. I have had patients complaining of headaches because they automatically increase the power each year assuming that their prescription must have gotten worse. I have had patients with corneal ulcers because they are wearing lenses that do not fit their eyes properly. I have patients developing corneal infiltrates because they are using a solution with a lens material that do not interact well. Allowing patients to wear contact lenses without proper supervision is not in their best interest. The rules are not applied evenly to all parties and the penalization for not abiding by the rules is significantly different for a seller of contacts lenses than they are for a prescriber of contact lenses. If I, as a doctor, cause harm to a patient from prescribing a contact lens or not verifying the proper contact lens / ocular interface, I can lose my license or be sued. The verification system is flawed. There needs to be a positive verification and not a simple lack of negative verification. There is no way to monitor a contact lens seller to make sure that their verification requests are being received by the practitioner. Patients make up fake doctors names and phone numbers or use information for doctors they have never seen. Sometimes patients say that they are allowed to order without providing the prescriber's contact information. The verification system is also in direct conflict with hipaa rules and regulations. We are routinely asked to confirm a patient's prescription and are not given an authorization of release to release that patient's information. We therefore have 72 hours to contact the patient, get an authorization of release, verify the prescription and respond to the seller. If a patient does not respond in a timely manner and therefore we do not respond within 72 hours, the order is processed due to a lack of negative verification. Sellers recently have begun calling of their own accord, without the patient initiating the request, when they are due to order new lenses. This goes against the whole idea of hipaa. Doctors have to abide by the rules that we will release the prescriptions. We have to abide by hipaa regulations. We have to explain to patients on a daily basis why what we are telling them are the rules that we have to practice by are not the same rules that the sellers are using. I believe that patients have the right to purchase any medical device from the provider of their choice. I also believe that all of those providers should follow the same set of rules and regulations. Holding a practitioner and a seller to two different sets of responsibilities is not a level playing field. The rules need to be more clear. The verification needs to be a positive verification. Penalties for not complying with the rules need to be significant enough to discourage abuse and need to be applied evenly.