16 CFR Part 315; Agency Information Collection Activities: Review; Comment Request; Contact Lens Rule: FTC Project No. R511995 #04233

Submission Number:
Stephen Klapper
Initiative Name:
16 CFR Part 315; Agency Information Collection Activities: Review; Comment Request; Contact Lens Rule: FTC Project No. R511995
January 28, 2017 To Whom It May Concern: On behalf of the Indiana Academy of Ophthalmology (IAO), which represents over 200 ophthalmologists in Indiana, I appreciate the opportunity to provide comments to the U.S. Federal Trade Commission (FTC) regarding "Contact Lens Rule, 16 CFR part 315, Project No. R511995." While we welcome changes to the Contact Lens Rule that prioritize patient safety, we are deeply concerned with the proposed new requirements that prescribers have their patients sign an acknowledgment of receipt form when provided a prescription for contact lenses and keep the form for three years. These additional requirements place an unfair burden on our doctors but do nothing to address the business practices of some online retailers that jeopardize the safety of the patients our doctors treat. As far as the IAO is aware, ophthalmologists in Indiana are providing patients with their prescriptions when requested in full compliance with the Contact Lens Rule as it is currently written. Indeed, our members are going to great lengths to comply with this rule despite serious concerns with its prescription verification system that we believe puts Indiana's patients at risk. The current rule's passive-verification system forces a rigid, eight-business-hour window on prescribers to verify prescriptions with sellers. After that window closes, the prescription is filled, regardless of whether a physician verified it. The American Academy of Ophthalmology (AAO) gathered anecdotal evidence which indicated that practices are seeing a significant number of errors due to incorrect or expired contact lens prescriptions, perhaps as high as 40 percent. Contact lenses that are not properly fit can cause corneal edema or swelling from lack of oxygen and warp the surface of the cornea resulting in a change in the refractive error (and correct prescription), Importantly, poorly fit contact lenses can also cause corneal ulcers and infections resulting in permanent vision loss. A passive verification system adds a documentation burden that compounds the tremendous burden from which ophthalmologists are already reeling due to Meaningful Use, MIPS, and MACRA documentation. If the newly modified prescription verification system is implemented, it would be ineffective. After one week, the prescriptions would be filled anyway, regardless of the actions of the prescribing eye doctor! The retention of waivers for 3 years that can be circumvented serves no purpose for prescription verification or patient safety, making them effectively useless. To compound these issues by creating an additional administrative burden for small business owners, like most of our members, is unfair and unnecessary as there is no evidence that our members are not complying with the current rule. The Indiana Academy of Ophthalmology wishes to emphasize that contact lenses are medical devices and the safety of our members' patients should not be sacrificed to enable the easier sale of these devices. Furthermore, we are not aware of any evidence indicating that ophthalmologists are not providing their patients with prescriptions for contact lenses. Our members should not face additional administrative burdens under this rule. We strongly urge the FTC to withdraw this proposal and re-approach the Contact Lens Rule with patient safety as its number one priority. Thank you for your attention to this important health care issue.