16 CFR Part 456 ; Agency Information Collection Activities: Review; Comment Request Ophthalmic Practice Rule (Eyeglass Rule): FTC Project No. R511996 #00661

Submission Number:
Lisa Heuer
Initiative Name:
16 CFR Part 456 ; Agency Information Collection Activities: Review; Comment Request Ophthalmic Practice Rule (Eyeglass Rule): FTC Project No. R511996
Thank you for requesting comments. It is important for everyone to have clarity on the issues surrounding this law. There are conflicting agendas related to the eyeglass rule: the doctors want to ensure public safety and preserve the sanctity of a spectacle Rx. Doctors have to undergo advanced training, assume several types of liability, and are inclined to genuinely care about the health of their patients. The numerous laws and regulations that we are required to follow drive overhead levels which are incompatible with the notion of providing free services. On the contrary, most patients just want the cheapest/fastest path of least resistance. That said, three significant facts remain: 1. Patients do not understand how pupil distance measurements are used for designing and fabricating eyewear. It's more complicated than a simple measure of the physical distance between the pupils. Misplaced location of the optical center of the lens can cause induced prism, asthenopia, diplopia, and blurred vision. The risk of error increases dramatically for people with higher prescriptions. 2. Patients do not understand that significant pathology can be present even when vision is perceived to be good. Any optometrist or ophthalmologist you consult on this issue can give you dozens of examples of patients who came in "because my glasses broke" or "because I want new glasses" but also have significant systemic or ocular pathology found during the exam. Less harmful but also important, many are seeing at the 20/30 or 20/40 level without realizing that they need an Rx update. 3. Patients do not understand the ANSI requirements and other safety concerns that go into dispensing glasses in the United States. Glasses from China can be very inexpensive in part because these standards are ignored. If a patient wants to know the pupil distance needed for a new pair of glasses, we need to ask a series of questions to ensure the data is supplied correctly for the given Rx and chosen frame. Our time and expertise are valuable, so this task should be completed by the organization that will be fabricating the glasses. As an optometrist, I take pride in the care that goes into the final prescription result for each of my patients. Each patient's prescription is demonstrated and fine-tuned with trial lenses while the patient is in the exam chair. It is upsetting for me when someone reports back with glasses made elsewhere, saying that that they don't work, only to figure out that they were made incorrectly after 15-60 minutes of trouble-shooting. It is not uncommon to find lenses upside-down, left/right reversals, induced prism, etc. Finally, our exams are defined by CPT codes 92004, 92014, 92015, S0620, and S0621. None of these codes require a pupillary distance as an exam element. My recommendations: 1. Continue to require that a copy of the spectacle Rx be issued to each patient after an exam. Penalize doctors who do not comply, but also allow for and enforce two-year expiration dates for spectacle prescriptions. Public health is compromised if the expiration dates are not respected. 2. Incorporate a clause in the law so that a doctor can over-ride an expiration date on an Rx (written by that same doctor) for reasonable exceptions without fearing accusations of negligence. An example of a reasonable exception would be a patient who loses his/her sole pair of glasses and needs a replacement asap to function. If that patient ignores the recommendation to get an exam, then has a devastating retinal detachment two weeks later, that doctor should not need to fear a lawsuit. 3. Enforce rules in a uniform manner. If a valid license (optician, OD, or MD) is required for dispensing glasses as a medical device, then don't allow international retailers to sidestep this requirement. We need an even playing field to avoid the perception that we are inflexible and too expensive in the eyes of the patient.