16 CFR Part 315; Agency Information Collection Activities: Review; Comment Request; Contact Lens Rule: FTC Project No. R511995 #00567

Submission Number:
Adrianne Drollette
North Carolina State Optometric Society
North Carolina
Initiative Name:
16 CFR Part 315; Agency Information Collection Activities: Review; Comment Request; Contact Lens Rule: FTC Project No. R511995
The North Carolina State Optometric Society represents nearly 1,000 student, active and retired doctors of optometry in North Carolina. We are the trusted voice of the profession of optometry and the North Carolina doctors of optometry on eye health and vision care in our state. Our mission is to advocate for the profession of optometry so we can best serve the eye health and vision needs in North Carolina. The North Carolina State Optometric Society appreciates this opportunity to offer comment on the Contact Lens Rule. 1. Is there a continuing need for the Rule? Why or why not? The Contact Lens Rule (the Rule) is required by statue, the Fairness to Contact Lens Consumers Act (FCLCA). Congress intended the law to enhance competition in the market for contact lenses by creating a federal right of patients to receive their contact lens prescriptions from their eye doctors, and establishing a process for contact lens sellers to verify the prescriptions of lenses ordered by consumers. However, as regulated medical devices that require a prescription from an optometrist or ophthalmologist, contact lenses have always been subject to government oversight. In its role, the Federal Trade Commission should seek to enhance competition in the fair and appropriate delivery of contact lenses to consumers. While most of the provisions of the Rule are required by the text of the FCLCA, the FTC should ensure that competitive practices designed for unregulated products do not undermine or elude critical contact lens patient safety protections. In other words, since the Rule must be maintained and many of its terms are proscribed by statute, moving forward the FTC should focus its efforts to enhance competition that best serves the interests of patients. Too often in the last decade, the FTC has silently allowed some sellers to gamble with patient health at the expense of innovation, improved safety, and other desirable results of competition. The FTC should not allow sellers to deceive patients in the single-minded pursuit of sales. The FCLCA provides rights to patients, so, ultimately, the Rule should protect patients with common sense safeguards. 2. What benefits has the Rule provided to consumers? What evidence supports the asserted benefits? Consumers benefit from the Rule by receiving their contact lens prescriptions from their eye doctors, and by having their prescriptions verified when they order contact lenses. It is our understanding that consumers have benefited from a wide selection of innovative products that are prescribed by their eye doctor, allowing more of our patients the option to use contact lenses for their vision needs. However, patients do not benefit when their eye health is sacrificed by unscrupulous sellers. The North Carolina State Optometric Society fully supports the existence of a robust contact lens marketplace, but believes competition is most beneficial when consumer safety is one of the market features. Until all sellers compete on patient safety, the FTC's lack of enforcement is more beneficial to sellers than to patients. 3. What modifications, if any, should be made to the Rule to increase its benefits to consumers? What evidence supports the proposed modifications? How would these modifications affect the costs the Rule imposes on businesses, including small businesses? How would these modifications affect the benefits to consumers? To improve the Rule for consumers, the North Carolina State Optometric Society strongly recommends the following: 1) The Federal Trade Commission (FTC) should prohibit the sale of contact lenses with an expired prescription. An expired prescription should be seen as an inherently invalid prescription. The FCLCA established that a prescription is required, and that eye doctors should verify those prescriptions. 2) The FTC should require that contact lens prescriptions include a maximum quantity of lenses that can be purchased prior to the prescription's expiration. 3) The FTC should limit the number of contact lens boxes that can be purchased from a retailer at one time. The amount should not exceed the maximum quantity noted on the patient's prescription. 4. What impact has the Rule had on the flow of truthful information to consumers and on the flow of deceptive information to consumers? Despite the Rule's requirements, retailers continue to sell contact lenses without proper prescriptions or prescription verification, which deceives consumers into believing that contact lenses are simple over--the-counter products. The proliferation of contact lens retailers over the past ten years has unfortunately resulted in the emergence of certain sellers who attempt to circumvent the FCLCA patient protections and are focused on profits and the number of contact lenses they can sell. Contact lenses are regulated medical devices that require professional supervision and care to mitigate the risks of misuse. 5. What significant costs, if any, has the Rule imposed on consumers? What evidence supports the asserted costs? While contact lenses are generally safe and effective medical devices, the North Carolina State Optometric Society is concerned that there is a widespread public misunderstanding regarding the need for appropriate care of lenses and physician oversight when using contact lenses. In 2014, the Centers for Disease Control and Prevention (CDC) reported that annually Americans make an estimated 930,000 visits to doctors' offices and outpatient clinics and 58,000 emergency room visits annually due to eye infections, adding $175 million in health care costs connected to keratitis-a typically preventable eye infection associated with improper contact lens use. The North Carolina State Optometric Society's members frequently care for patients who have experienced contact lens related infections and complications. The eye care visits and treatments associated with these events is an increased cost to consumers. 6. What modifications, if any, should be made to the Rule to reduce any costs imposed on consumers? What evidence supports the proposed modifications? How would these modifications affect the benefits provided by the Rule? At a minimum, the basic patient safeguards outlined in the FCLCA must be enforced to protect patients and reduce unnecessary costs. Retailers should be punished for selling contact lenses without a valid prescription, which increases risks for the patient and ultimately leads to higher health expenses. Individuals who attempt to sell products via social media and the companies that host the social media sites must be informed of the legal requirements surrounding the sale of contact lenses. The FTC should prevent the sale of large quantities of contact lenses when that sale could compromise a patient's eye health. Additionally, more needs to be done to ensure that patients are aware that contact lenses are regulated medical devices, whose safe use and optimal performance depends on eye examinations and professional supervision. 7. What benefits, if any, has the Rule provided to businesses, including small businesses? What evidence supports the asserted benefits? Although the Rule was intended to increase competition, the online contact lens market is dominated by one large business. On July 30, 2014, during a hearing before the Senate Judiciary Committee's antitrust panel, R. Joe Zeidner, General Counsel for 1-800 CONTACTS, indicated that his company controlled approximately three quarters of the online contact lens retail market. So, while the FCLCA was intended to increase competition, an unintended consequence has been the emergence of one dominating online retailer. 8. What modifications, if any, should be made to the Rule to increase its benefits to businesses, including small businesses? What evidence supports the proposed modifications? How would these modifications affect the costs the Rule imposes on businesses, including small businesses? How would these modifications affect the benefits to consumers? To improve the Rule for small business, including the practices of doctors of optometry, the North Carolina State Optometric Society suggests the following: 1) FTC should no longer allow the use of robocalls for verifying patient prescriptions. This would protect thousands of small businesses from these disruptive calls which, too often, communicate incomplete information or are difficult to understand. 2) FTC should require that for larger contact lens retailers, the retailer must make available more than one individual at a company to act as the contact person for physician questions and concerns. 3) FTC should develop a distinct complaint submission process for contact lens related concerns. 9. What significant costs, if any, including costs of compliance, has the Rule imposed on businesses, including small businesses? What evidence supports the asserted costs? Physician small-business owners spend significant time responding to prescription verifications that are inaccurate or incomplete. Robocalls, which automatically redial until a message is fully communicated to someone at a physician's practice, are a cost to businesses as it often interferes with treating patients and can tie up phone lines that may be needed for urgent patient matters. An inability to reach a real human being at a large contact lens retailer is another cost to physician small businesses whose personnel may spend significant time on hold or attempting to use various phone numbers or automated prompts to reach live person. The costs that physician small-business owners expend related to the Rule are actually most often related to non-compliance on the part of retailers. If physician small-business owners only received accurate prescription verification requests for lenses, there would be no added costs related to robocalls or an inability to appropriately reach contacts at retailers. 10. What modifications, if any, should be made to the Rule to reduce the costs imposed on businesses, including small businesses? a. What evidence supports the proposed modifications? b. How would these modifications affect the benefits provided by the Rule? Eliminating robocalls, providing verifications in writing, and requiring more than one contact person at a retailer to be available to discuss prescription concerns would reduce the burden on the small businesses of doctors of optometry. 11. What evidence is available concerning the degree of industry compliance with the Rule? In 2010, one of our officers treated a 16 year-old male with sudden severe vision loss and an extremely red, painful eye. He had purchased colored contact lenses without a prescription at a local beauty supply store. There was no process of evaluating his cornea to ensure proper corneal health and sustainability to lens wear. He was not given a contact lens fitting by a licensed eye care professional, nor was he given instructions regarding lens care and hygiene. All of these pieces are critical steps to ensure patient health, safety and welfare. If a proper contact lens fitting is not performed, then patients are at risk for a multitude of corneal issues including corneal ulcers and infections which can lead to vision loss and blindness. This 16 year-old young man was not offered the chance for a contact lens fitting or any instructions regarding proper lens care, hygiene, or contact lens insertion and removal. Because this patient purchased lenses from a location that did not ask for a prescription, he developed a severe pseudomonas corneal ulcer that ultimately cost him his vision. He went on to endure a corneal transplant. After the surgery, his best corrected vision improved only to the 20/50 level and his vision will never be the same. Personally, this has taken an emotional toll on him and led to feelings of self-guilt and shame. It is imperative that patients are protected from the threat of harm by obtaining contact lenses only through valid prescriptions written by optometrists and ophthalmologists. These prescriptions must be properly verified by sellers. Neglect in any of these steps may conclude in a loss of vision as described by this 16 year-old. 12. What modifications, if any, should be made to the Rule to account for changes in relevant technology or economic conditions? What evidence supports the proposed modifications? The use of robocalls must be banned. This change would account for changes in technology and an overall shift in public opinion regarding the use of automated phone calls that has occurred in the 10 years since the Rule was drafted. 13. Does the Rule overlap or conflict with other federal, state, or local laws or regulations? If so, how? What evidence supports the asserted conflicts? With reference to the asserted conflicts, should the Rule be modified? If so, why, and how? If not, why not? NC General Statute § 90-127.3. Copy of prescription furnished on request. All persons licensed or registered under this Chapter shall upon request give each patient having received an eye examination a copy of his spectacle prescription. No person, firm or corporation licensed or registered under Article 17 of this Chapter shall fill a prescription or dispense lenses, other than spectacle lenses, unless the prescription specifically states on its face that the prescriber intends it to be for contact lenses and includes the type and specifications of the contact lenses being prescribed. The prescriber shall state the expiration date on the face of every prescription, and the expiration date shall be no earlier than 365 days after the examination date. Any person, firm or corporation that dispenses contact lenses on the prescription of a practitioner licensed under Articles 1 or 6 of this Chapter shall, at the time of delivery of the lenses, inform the recipient both orally and in writing that he return to the prescriber for insertion of the lens, instruction on lens insertion and care, and to ascertain the accuracy and suitability of the prescribed lens. The statement shall also state that if the recipient does not return to the prescriber after delivery of the lens for the purposes stated above, the prescriber shall not be responsible for any damages or injury resulting from the prescribed lens, except that this sentence does not apply if the dispenser and the prescriber are the same person. Prescriptions filled pursuant to this section shall be kept on file by the prescriber and the person filling the prescription for at least 24 months after the prescription is filled. (1981, c. 496, s. 14.) Below is the North Carolina Board of Optometry's policy regarding the release of contact lens prescriptions: Board Policy on Release of Spectacle and Contact Lens Prescriptions A patient is entitled, without equivocation, to a copy of his or her spectacle lens prescription following a comprehensive eye examination with refraction resulting in a spectacle lens prescription. Minimum information required pertaining to the lens power(s) on such prescriptions include the following for both the right and left eyes: the spherical power, the cylindrical power including the axis, prism (if prescribed) and the power of the add (when prescribed). Special requirements such as the type of lens, tints, coatings, polycarbonate, etc may be included where such requirements may be indicated. A patient purchasing their prescription eyewear from a seller other than the prescribing optometrist or ophthalmologist should recognize that it is the responsibility of an optical dispenser filling such prescription(s) to make those physical assessments of the patient's anatomical features required to determine the measurements necessary to ensure that the lenses that have been prescribed fit properly before the patient's eyes (see Sections 90-235 and 90-236 of Article 17 of the North Carolina General Statutes). Such measurements include but are not necessarily limited to the intended wearers facial features, the size and shape of the frames selected by the patient into which the lenses are to be mounted, appropriate inter-pupillary distances (distance and near) for the accurate decentration of the lens, and the segment heights when progressive or multifocal lenses are prescribed. In keeping with the above, and before the dispensing of prescription eyewear to a patient, the accuracy of the prescription should be verified by a licensed optical dispenser as to the accuracy of the lens power(s) and the proper decentration of all variables. In those instances where multifocal or progressive lenses have been prescribed the height and decentration of the ‘adds' should be verified and the eyewear adjusted comfortably to the patient's face before it can be said that the prescription eyewear has been ‘properly dispensed' in accordance with their prescription. The law is very precise in the differentiation of spectacle and contact lens prescriptions. Unless a prescription states on its face that the prescriber intends for it to be for contact lenses and includes an expiration date and the type and specifications of the contact lenses being prescribed, it is a spectacle prescription and can only be filled and dispensed as such. It is the opinion of the Board that until all requirements of a satisfactory fit of contact lenses have been determined by the optometrist, a contact lens prescription cannot be written. Further, all contact lenses used in the determination of a contact lens prescription are considered to be diagnostic lenses and the use of such lenses by anyone other than an optometrist or physician, or an ophthalmic assistant under his or her direct and personal supervision, is not permissible under provisions of North Carolina law. No optometrist is required, nor is he or she expected, to delegate the responsibility for the fitting of a contact lens to any person not licensed to do so, and to do so is in violation of North Carolina law and Optometry Board Rules and Regulations. Under North Carolina law, contact lenses can be fitted and prescribed only by licensed optometrists and physicians (“practitioners”). They can be dispensed legally only upon a valid, current prescription issued by a practitioner. It is recognized that increasing numbers of patients are purchasing contact lenses through alternative sources; therefore, it is important that practitioners recognize and document whenever possible this type of activity in the patient's chart when applicable. Because the purchasing and unsupervised use of contact lenses without a valid, current prescription has the potential to be harmful to the safety and wellbeing of patients a practitioner may consider termination of a patient's care when a patient is determined to be non-compliant. It is further recommended that in the event any seller of contact lenses requests confirmation of expired or otherwise invalid contact prescriptions the practitioner institute procedures to promptly respond to such inquiries. Particular care should be taken to assure that such procedures minimize the chance that “passive permission” (failure to respond to a request for verification of a prescription by any seller of contact lenses within a stated time period, which results in shipment of the lenses to the patient due to lack of response by the practitioner) be given to ship or sell contact lenses for which the prescription has expired. In order to minimize confusion on the part of patients, the optometrist should adequately communicate with each patient about the patient's expectations of the optometrist's services. If contact lenses are desired or are being considered, then the patient should know in advance what professional services are required, and what the approximate costs of these services will be. This is especially true if the patient is contemplating having the prescription filled or dispensed by a third party. While the patient has the right to have his or her contact lens prescription dispensed by any dispenser who is legally authorized to dispense contact lenses in the State of North Carolina, the practitioner has the right, prior to fitting the patient, to refuse to fit contact lenses or accept as a patient any person who does not agree in advance to comply with the follow-up protocols as established within the practitioner's practice. In order to aid in the prevention of misunderstandings, it is recommended that each practitioner have his or her office protocols available in order to inform patients presenting for examination and who wish to be fitted with contact lenses. Such protocols should be worded so as to be easily understood by the patient (e.g. avoiding technical language or terms) and may describe charges for procedures involved in the fitting of the contact lenses as distinct from charges related to a routine eye examination, as well as to the expected patient compliance with regularly scheduled office visits and follow-up care while wearing contact lenses. In the interest of good doctor-patient communication it is suggested that at the time of the patient's initial office visit for the fitting of contact lenses and before a final contact lens prescription is determined, a patient for whom contact lenses are to be prescribed should be informed of the practitioner's patient follow-up protocols for the type of lenses being prescribed and a follow-up appointment made for the patient in accordance with such protocols. In the event that the patient is given a prescription to be filled by a third party, the patient's record should denote the fact and the time of the patient's follow-up noted in their chart. The prescription should contain the number of lenses to be dispensed, the number of refills that are authorized and an expiration date consistent with the type and modality of use of the lenses that are prescribed, such expiration date should be no later than the date of the patient's next regularly scheduled follow-up appointment. / Finally, when a contact lens prescription is issued to a patient it shall contain an expiration date and shall explicitly state on its face that it is for contact lenses. Further, the prescription shall include the type of lens and all specifications necessary for the ordering or fabrication, type and quantity of lenses to be dispensed, number of refills authorized, an expiration date and whether lenses are to be dispensed as written or if substitutions are allowed. Words or phrases such as "o.k. for contact lenses", "fit with contact lenses", "contact lenses may be worn", etc. do not constitute a contact lens prescription. An optometrist cannot delegate in writing or otherwise the responsibility of determining the suitable fit of, and thus the prescription for, a contact lens. That responsibility clearly belongs to the prescriber. To minimize the risks of misunderstanding between the optometrist and his or her patient, it is recommended that all prescriptions released to patients that are intended for spectacle lenses to so state by having the prescription blanks printed or stamped with words to that effect: [e.g. "this is a spectacle lens prescription only", "not intended for contact lenses", etc.] e.g. “this is a spectacle lens prescription only”, “not intended for contact lenses”, etc., etc. Adopted 06/05/03 Amended03/29/08 As you can see, under North Carolina law contact lenses may only be dispensed upon a valid, current prescription issued by a practitioner. Further, contact lens prescriptions must contain specific information regarding the contact lens parameters and it must be clear that it is a contact lens prescription with a specified expiration date. Thank you for the opportunity to comment on this important issue. If you need additional information, please contact Adrianne Drollette at 919-977-6964. Sincerely, Adrianne M. Drollette Executive Director North Carolina State Optometric Society 150 Fayetteville Street, Suite 920 Raleigh, NC 27601 Adrianne@NCEyes.org 919-977-6964