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Prepared Witness Testimony The House Committee on Energy and Commerce
Fairness to Contact Lens Consumers Act
Subcommittee on Commerce, Trade, and Consumer Protection
Dr. J. Pat Cummings O.D.
Mr. Chairman, I am Pat Cummings, Immediate Past President of the American Optometric Association (AOA) and a private practice optometrist from Sheridan, Wyoming. I appreciate the opportunity to appear today to discuss HR 2221, the "Fairness to Contact Lens Consumers Act," on behalf of AOA and its 34,000 members. HR 2221 would require that doctors provide contact lens prescriptions to patients following a fitting period, and respond to requests to verify the prescription by others acting on behalf of the patient. Let me state right away that the AOA supports this consumer right to receive their prescription and have it verified to a third party. We believe that the vast majority of doctors do provide patients with this information; 35 states have prescription release provisions, and the Federal Trade Commission (FTC) found in a 1995 study that 92 percent of patients who asked for their prescriptions received them. Notwithstanding those figures, we recognize that all patients should have equal access to this information, and we do support the intent of HR 2221 to provide it to them. The primary issue for AOA and its members is not where patients purchase replacement lenses. It is simply to assure two things: first, that the process for verifying the prescription upon which the purchase is based provides the doctor with all the pertinent patient information required, so that the doctor may properly and efficiently respond to the request; and second, that lenses are provided to patients only when the prescription has in fact been positively verified. It is important to note that we believe that positive verification should apply to all sellers of lenses, including private practitioners, optical chains and others. Current methods used by sellers to verify prescriptions fall into one of three basic categories: - FAX requests, which may or may not include adequate information about the patient for the doctor to accurately respond, and may not in fact be handled appropriately when the doctor does respond. For example, the seller may tell the patient the doctor hasn't responded when they have, or conversely may provide the patient with lenses when the doctor has indicated no valid prescription exists. - Automated phone calls, which have proven difficult if not impossible for doctors to respond to. A simple statement on a website that says placing an order confirms that a valid prescription exists, which is in fact no verification at all. Let me provide examples of problems associated with each of these methods. Doctors have been accused of being unresponsive to requests for verification. One of our members has sent us the following account of a recent FAX situation addressing this issue as follows: "Patient X is a long-term patient and contact lens wearer. She has often chosen to receive lenses from another supplier. I examined her two weeks ago and found normal eye health and good contact lens wear. We received a fax from 1-800Contacts a few days later asking for prescription verification. We returned the fax with the appropriate information immediately. Two days later we received a second FAX for the same information. My staff took time out of a busy day to reply, this time with a note stating that this was our second response. The patient then called my office a few days later stating she had received a note from 1-800Contacts claiming we would not release her contact lens prescription information. Further, they requested she fill out a complaint form and send it to the State Board of Examiners in Optometry. We subsequently called 1-800Contacts. They informed us they had made a mistake and had indeed received both replies of verification. They said they would contact the patient to inform her we were in compliance. Then, we received a third FAX for the same patient looking for the same verification." This is not an unusual occurrence; I have been told similar stories by numerous colleagues over the past year. Another member sent the following on the automated message method: "At 9:15AM on August 13, 2003, we received an automated call from 1-800Contacts. The call asked if we would be compliant in processing a request to verify a prescription; if so press 1, if not press 2. When I pressed 1 the recording said we will note that you will not be compliant with your patients' request and the call was ended. I verified that I had pressed 1 on the phone screen. No patient name or prescription was given." Again, this is a story I have heard repeatedly from colleagues in the past year, and it raises two basic concerns. First it places a doctor legitimately attempting to comply with a verification request in a potentially adversarial situation with a patient as well as being incorrectly reported to a State Board; second it raises the very real possibility that lenses -3- were provided to a patient with no knowledge of whether a valid prescription exists simply on the basis that some request was made and no response received. Finally, Mr. Chairman, there are the websites who make no attempt at all to verify that a prescription actually exists. Two such examples are Vision Direct and Coastal Contacts. Both these sites simply say in small print that by placing an order you confirm you are a successful contact lens wearer with a valid prescription. There is no request for doctor information and no attempt to verify the existence of a valid prescription. Just last week I received the following from a colleague describing an adverse event for a patient who obtained lenses off of one of these sites as follows: "Patient X has been ordering his contact lenses off the internet from Vision Direct. He was wearing Johnson/Johnson Acuvue lenses extended wear. While ordering a new supply of lenses from Vision Direct he inquired about the new 30-day continuous wear lenses. They informed him that they did indeed have the lenses and were more than happy to supply the lenses to him. Vision Direct had never received a valid prescription from an optometrist or an ophthalmologist but had just started mailing lenses to him from the information which he provided to them from the lens parameters found on the contact lens boxes. They also changed him to the Focus Night/Day lenses without valid authorization. Worse yet, they never provided him with any information as to how long the lenses could be worn or how frequently the lenses needed to be changed to a new pair. Needless to say, without any direction, he started wearing the lenses anywhere from two to three months continually before he would change to a new pair of lenses. He would only change them when his vision became blurred or when the lenses started irritating his eyes. He came to my office complaining of very blurred vision and severe pain in his right eye. From my examination, I determined that he had developed very serious corneal stromal edema as well as a superficial keratitis. After three weeks of medical treatment, I was able to restore his vision back to the 20/20 level. These lenses were provided to this gentleman without a proper valid prescription or proper medical supervision. Thankfully the outcome in this case was good, however, it very possibly could have ended with severe vision loss." Adding a simple provision to HR 2221 requiring sellers to provide doctors with basic information will address two important issues raised by these examples - first, it will reduce the number of lenses being provided inappropriately without a prescription; and second, it will allow doctors to respond more efficiently to requests and minimize the chance that they will be unfairly subjected to potential substantial penalties. In addition, this will actually promote fair competition among sellers, because some sellers will no longer have the advantage of disregarding the need for a valid prescription. This we believe is a reasonable approach that improves the bill with no undue burden on any party. Our second concern is that lenses should be sold only when the existence of a valid, unexpired prescription is positively verified by the doctor. Why is this so important? Contact lenses are prescription medical devices regulated by the Food and Drug Administration. They can only be dispensed to patients with a valid, current prescription. In fact, the FDA has published a consumer advisory telling consumers not to order contact lenses by mail, phone or on the internet without a current prescription, because of health risks associated with contact lens wear. As the Federal Trade Commission staff pointed out in comments to the Connecticut Board of Examiners for Opticians in May 2002 there are significant health issues concerning the sale of contact lenses, primary among them being ensuring that contact lens wearers return to their doctors for regular eye examinations. The staff document correctly concludes, "The primary health care concern with contact lenses appears to be ensuring that contact lens wearers return to their doctors regularly for eye examinations. Customers incur health risks if they forego regular eye exams that would allow the optometrist or ophthalmologist to spot emerging health problems in the early stages." As noted in my previous example, that is a very real risk when lenses are provided without a properly verified prescription. The only appropriate verification system consistent with the status of contact lenses as FDA regulated devices and the only way to be absolutely certain that these risks are eliminated, is one in which the seller either has a copy of the prescription or has it positively verified by the doctor. Anything less is subject to the vagaries of both technical and human error. You can't call the pharmacy and get a drug prescription filled unless the pharmacy has a copy of a valid prescription on file or gets approval from the doctor. It should be no different for contact lenses. If the concern is that doctors will not comply, then make the penalties more severe. Having served in both state and national positions for many years, my strong sense is the penalties called for in HR 2221 are more than sufficient to capture the attention of the few practitioners who otherwise may not comply, but we don't have any qualms about increasing them substantially if some feel it necessary. Again, Mr. Chairman, let me emphasize that we support the intent of HR 2221 to provide patients with their contact lens prescriptions, and to require doctors to respond to requests to verify those prescriptions. Our sole concern with the legislation is that it should also require sellers to provide doctors with basic patient information, in an appropriate manner, so we may respond efficiently, and require that prescriptions be positively verified by the doctor before lenses are sold. We believe this is a balanced and reasonable approach that addresses issues relating to both competition and health concerns. Thank you for the opportunity to present testimony on this important issue. We hope you find our input useful, and that we can work with all interested parties to move this legislation forward in a positive fashion.
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