The Health Care Alliance for Patient Safety (“APS”) submits these comments in response to the above-referenced announced workshop and comment period to discuss competition in the contact lens market. With the announcement, the Commission requested comments from the public for purposes of reviewing the Contact Lens Rule as part of its 10-year review process.
APS is comprised of health care providers, medical device manufacturers, vision insurers and other organizations that support the need for heightened awareness regarding pressing threats to a patient’s health and safety. We recognize the need to educate consumers about the safety risks involved in wearing contact lenses. Our mission is to build awareness while advocating for enforcement of the law and other public policy solutions designed to safeguard public health. APS understands the need to provide both competition and safety in the sale of contact lenses. However, we are concerned that the FTC has not fully considered the overall safety risks associated with contact lens wear in an evolving marketplace. Our hope is that the March 7, 2018 workshop provided insight and avenues to ensure that the law is enforced without deterring technological advancements or undermining doctor-patient relationships.
When the Fairness to Contact Lens Consumers Act was signed into law in 2004, congressional intent was to promote competition of retail sales of contact lenses while decreasing the overall cost of purchasing contact lenses. At the same time, Congress sought to ensure that new developments in the market upheld a high quality of patient eye care. Unfortunately, APS believes certain aspects of the original congressional intent have not been met. In the FTC’s Proposed Rule Concerning the Contact Lens Rule (“Proposed Rule”) issued on December 7, 2016, the FTC failed to address several fundamental problems with the current contact lens market.
Specifically, APS is very concerned with several patient-safety issues regarding excessive-quantity sales, contact lens brand substitution and out-of-date communication methods that may undermine patient safety in the prescription passive-verification process. Individually, each of these issues pose significant threats to patient eye health. In addition, we are deeply concerned about the FTC’s proposed signed acknowledgment form for every contact lens wearer that will create additional and unnecessary burdens on our nation’s eye doctors while ultimately threatening access to care. As a whole, these issues create an environment where eye health problems become more prevalent due to patients’ growing disregard for regular eye health exams and the evaluation of contact lens interaction with patients’ eyes. In addition, this approach fails to follow congressional intent as well as scientific recommendations from the Food and Drug Administration (“FDA”) and the Centers for Disease Control and Prevention (“CDC”). This intent and these recommendations were put in place because inappropriate use of contact lenses can lead to serious eye injury, including impaired or full loss of vision. For this reason, the proper “Standard of Care” dictates that contact lens wearers receive periodic comprehensive eye exams to determine the proper ocular response and the continuation of safe contact lens.The push to devalue the doctor-patient relationship for contact lenses will lead to more patients experiencing adverse events based on either poor hygiene practices or changes in eye physiology, ultimately leading to more vision problems for contact lens wearers and possibly more Americans losing their vision.
Excessive Quantity Limits
The Commission has already acknowledged that online consumers receive notices to purchase more contact lenses in excess of the remaining life of their prescription. The Commission acknowledged a Johnson & Johnson Vision Care, Inc., survey showing that “58% of the online consumers that were surveyed indicated that they had received an email or letter from their retailer reminding them that their prescription was expiring soon and that the majority of these consumers had ordered more lenses as a result.”
It is essential for sellers to follow the terms and intent of contact lens prescriptions. If a prescription is written for one year, then the most a seller should be allowed to sell to a consumer during the life of that prescription should be 730 lenses. This underlining premise of quantity sales is based off the original intent of the law and the rules and requirements by the FDA and the FTC related to the integrity of prescriptions. This premise is also clearly implied in the FTC’s Rule by requiring sellers only to sell lenses “in accordance with a contact lens prescription.” APS also understands that emergency situations arise where patients need a limited refill to replace ripped or lost contact lenses. Fortunately, some states have provided precedence for these situations. The Texas Department of Health clarifies that a patient may receive a two-month extension of their current contact lens prescription if their doctor determines that an emergency exists. With this in mind, APS encourages the FTC to follow their own intent, enforce limitations on excessive contact lens quantities and issue a statement indicating the Commission’s clear intent regarding this Rule while following precedence. In following precedence, the APS asks the FTC, when acting on quantity limits, to defer to the patient-doctor relationship, which should hold the final decision for any patient health care decision.
Contact Lens Brand Substitution
As with Quantity Limits, the Commission has already acknowledged the serious consequences that come from freely substituting contact lenses. Contact lenses are not commodities, but rather Class II and Class III medical devices regulated by the FDA. Manufacturers and prescribers both agree that freely substituting contact lenses could result in significant injury including corneal ulcers and impaired or full loss of vision, but also undermine consumers’ confidence in the assurance that they are always receiving the exact lenses prescribed to them by their doctor.
The Commission has already decided that “unauthorized alterations violate the Rule as currently written, and thus there is no need to amend the Rule to address this issue.” Yet, given that the FTC has stated, “it is unclear how frequently illegal substitutions are occurring, or how many sellers are engaged in this activity,” the FTC has declined to take any further action to gather evidence of illegal substitutions.
APS recommends that the FTC seek further evidence of the illegal substitution of contact lenses, and increase enforcement efforts to correct any illegal action.
Out-of-Date Methods for Passive-Verification
In the proposed rule in December 2016, the FTC took the position that updates to the methods used in the verification process were not needed “because the current regulatory framework sufficiently prohibits the use of expired prescriptions.” APS believes the current advancements in technology allow for the FTC to issue guidance on new acceptable forms of verification, (e.g. emails) and disallow outdated forms of verification, like robocalls. Many of the outdated methods currently used do not constitute “direct communication” as intended by Congress.
APS supports the passive-verification process. However, advancements in technology now allow both sellers and prescribers to keep electronic health records. FTC action to modernize its guidance around passive-verification communication while excluding antiquated technology (e.g. robocalls) would provide greater documentation and the possibility of greater oversight in the verification process. Greater oversight, understanding and documentation will ultimately create a safer and more efficient environment for contact lens wearers and the verification of their prescriptions through clearer, concise and accurate communication between the prescriber and the seller.
In the FTC’s proposed rule, the Commission proposed to require a signed acknowledgment form of prescription release that would allow the patient to acknowledge receipt of their contact lens prescription. In addition, the prescriber would be required to maintain this acknowledgement form for not less than three (3) years so they may be available for inspection by the FTC.
APS understands that the proposed requirement was in response to a small number of claims that suggest that prescribers were not freely giving patients their contact lens prescription as required under the law. In fact, the FTC itself conceded that “many reports of compliance and noncompliance are anecdotal and robust empirical data is sparse.” It is our belief that the Commission’s purpose for the signed acknowledgment form was to educate consumers of their rights while also subjecting doctors to spot investigations regarding the adherence to the law. APS believes that less intrusive means can be used to educate consumers of their rights to freely receive their prescriptions while also ensuring doctors follow the law.
Signage can inform patients of their rights under the law while at the same time providing a form of communication (e.g. phone number) to report any bad actors. This form of education is less intrusive and less burdensome while arguable more informative than a signed paper acknowledgment. APS urges the Commission to consider signage or other forms of educating consumers of their rights that are less intrusive and less burdensome than a signed acknowledgment form.
APS is encouraged by the FTC’s interest in gathering input from doctors, contact lens manufacturers, retailers, patients and health agencies like FDA and CDC, and we look forward to furthering discussions on how to better the contact lens market. The work that has been done over the last year is extremely important to ensure updates to the Contact Lens Rule prioritizes patient health and education.
APS asks the FTC to consider carefully the patient health risks that come with excessive quantity limits and free substitution. APS also asks that the FTC consider updates to methods used in the passive-verification system to ensure direct communication is accomplished and patients receive the correct contact lens prescription. Finally, APS would ask the FTC to consider other forms of educating patients of their rights under the law rather than a signed acknowledgment form. A signed acknowledgment form is intrusive to the doctor-patient relationship and is less effective to other forms that can achieve the same objective.
APS commends the FTC for their thoughtful review of these comments on the Proposed Rule and thanks the FTC for their time and consideration.Read more
(WASHINGTON) – Health Care Alliance for Patient Safety (Alliance for Patient Safety) today released the following statement following the Federal Trade Commission’s (FTC) workshop entitled, “The Contact Lens Rule and the Evolving Contact Lens Marketplace.”
“Doctors, contact lens manufacturers and eye care professionals from across the country today sent a clear message to the FTC: It’s time to follow the lead of other government agencies, like the Centers for Disease Control and Prevention and the Food and Drug Administration, to carefully consider patient safety and the integrity of the patient’s prescription when contemplating new government regulations,” said Deanna Alexander, O.D., Chair of the Alliance for Patient Safety. “As it currently stands, the FTC’s proposed rule will only increase burdens on small businesses and doctors, which will ultimately strain patient access, and allow for undermining the integrity of the prescription. Simply put, it’s a solution in search of a problem.”Read more
(ALEXANDRIA, VA) – Health Care Alliance for Patient Safety (Alliance for Patient Safety) supporters from across all 50 U.S. states are preparing to descend on Washington, D.C., on Wednesday, March 7, 2018, for the Federal Trade Commission (FTC) workshop titled, “The Contact Lens Rule and the Evolving Contact Lens Marketplace.”
Eye diseases, vision loss, and eye disorders create an estimated $139 billion economic burden in the U.S.¹ and millions of Americans suffer from untreated or undiagnosed vision impairments.² Members of the Alliance for Patient Safety are increasingly concerned that eye health and vision care are not priorities in the national health care discussion.
“The current verification of contact lens prescriptions includes issues like robocalls, excessive-quantity sales and lens substitutions, which create a system that treats the purchase of contact lenses as a mere economic transaction, without sufficient regard for patient safety,” said Deanna Alexander, O.D., Chair of the Alliance for Patient Safety. “The Alliance for Patient Safety believes the FTC should recognize the need for a contact lens verification process that is dedicated to protecting the well-being of patients and
ensure that contact lenses are used safely and appropriately.”
The following Alliance for Patient Safety members and advocates will speak on panels at the FTC’s workshop:
- Dr. Carol Lakkis, BScOptom, Ph.D. – Participant on Panel II: Contact Lens Health and Safety Issues. Dr. Lakkis is Clinical Research Fellow and Head of Applied Clinical Science for Johnson & Johnson Vision Care, Inc.
- Dr. David A. Cockrell, O.D. – Participant on Panel IV: Examining the Verification Process and Panel V: Prescription Release and Consumer Choice. Dr. Cockrell is Diplomate American Board of Optometry, Past President, American Optometric Association (AOA).
- Mr. Shaun Schooley – Participant on Panel IV: Examining the Verification Process. Mr. Schooley is the Vice President of Global Marketing Technology, CooperVision.
- Dr. Zachary McCarty, O.D. – Participant on Panel V: Prescription Release and Consumer Choice. Dr. McCarty is the Chair of the Quality Improvement and Registry Committee for the AOA.
- Mr. Peter A. Menziuso – Participant on Panel VI: Looking Ahead: Potential Market Disruptions and Their Impact on Competition, Consumer Protection, and the Contact Lens Rule. Mr. Menziuso is President, North America, Johnson & Johnson Vision Care, Inc.
In addition to panelists, doctors of optometry from across all 50 states will attend the workshop and submit formal comments advocating for policy that increases patient safety and ensures access to highquality vision health care.
Members of the press interested in learning more about the Alliance for Patient Safety or talking with Alliance advocates or panelists can visit www.patientsafetytoday.com.
(ALEXANDRIA, VA) – Eye diseases, vision loss, and eye disorders create an estimated $139 billion economic burden in the U.S.1 and millions of Americans suffer from untreated or undiagnosed vision impairments.2 Yet eye health and vision care are not priorities in the national health agenda. The Health Care Alliance for Patient Safety, launched today, will work to fill the gap, advocating for solutions to advance patient eye health, vision care, and safety and to elevate the doctor-patient relationship – the essential foundation of health care decision making.
Advancing policy and collaboration between leading health care advocates, innovators, and treatment specialists is essential to push patient eye health care and vision protection forward. The Alliance for Patient Safety will build on important eye health and technological advancements, and work with patients, policy makers, and regulators to deliver transparent and factual information regarding eye health products, procedures, technology, and safety.
“The Alliance for Patient Safety exists to advance patient eye health and provide patients with the latest credible information to improve and safeguard eye health,” said Deanna Alexander, O.D., Chair of the Alliance for Patient Safety. “We will set out to ensure patient eye health and safety are at the center of the nation’s health care agenda and to advance patient health through education, empowerment, and the preservation of the doctor-patient relationship as the absolute foundation of sound health care decision making.”
The Alliance for Patient Safety is a policy advancement and information collaboration between leading eye health advocates, innovators, and trusted voices from the eye health community, all united by a commitment to ensuring quality care and improved patient outcomes. Through advocacy and education initiatives, the Alliance for Patient Safety:
- Supports laws, regulations, increased enforcement, and other public policy solutions designed to safeguard public health
- Heightens awareness to patients, legislators, and regulators of the importance of the doctor-patient relationship and existing and potential threats to patients’ eye health and safety
The American Optometric Association (AOA) and Johnson & Johnson Vision joined the Alliance as Leadership and Charter members with CooperVision, Inc. joining as an Associate and Charter member.
To become a local advocate or to get involved in protecting patient safety, visit www.patientsafetytoday.com.
The Federal Trade Commission will hold a public workshop in Washington, DC, on March 7, 2018 to explore issues regarding competition in the contact lens marketplace, consumer access to contact lenses, prescription release and portability, and related subjects.
The workshop is being held in conjunction with the Commission’s regulatory review of the Contact Lens Rule. A Notice of Proposed Rulemaking (NRPM) was issued in December 2016 announcing proposed changes to the Commission’s Contact Lens Rule.
The Rule, in place since August 2004, helps to promote competition in the retail sale of contact lenses by facilitating consumers’ ability to comparison shop for contact lenses. It imposes obligations on both eye-care prescribers and contact lens sellers.
When a prescriber completes a contact lens fitting, the Rule requires the prescriber to automatically provide the patient with a complete copy of the contact lens prescription, and to verify or provide the prescription to authorized third parties.
The Rule also requires that contact lens sellers dispense contact lenses only in accordance with a valid prescription the seller has received from either the patient or prescriber, or has verified via direct communication with the prescriber.
Topics to be discussed at the workshop include, but are not limited to:
- Consumers’ ability to comparison shop for contact lenses;
- The use of electronic health records, patient portals, and other technology to improve prescription portability;
- The interaction between the Contact Lens Rule and emerging telehealth business models;
- The potential for new technology to improve the prescription verification process; and
- Modifications to the Rule to foster competition and maximize consumer benefits, including benefits to eye health.
The workshop is free and open to the public, and the Commission is accepting requests to participate as a panelist from interested parties through January 5, 2018, via email at: firstname.lastname@example.org(link sends e-mail). The FTC also welcomes written comments on the issues to be discussed at the workshop. Interested parties may file a comment online until April 6, 2018, at: https://ftcpublic.commentworks.com/ftc/contactlensworkshop.
To file a comment or request to participate on paper, write “Contact Lens Rule, 16 CFR Part 315, Comment, Project No. R511995” on your comment, or “Contact Lens Rule, 16 CFR Part 315, Request to Participate, Project No. R511995,” on your request, and mail your submission to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue, NW, Suite CC-5610 (Annex F), Washington, DC 20580, or deliver your submission to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street, SW, 5th Floor, Suite 5610 (Annex F). Requests to participate must be received on or before January 5, 2018. The public comment period will remain open until April 6, 2018, and comments received will be posted on the workshop’s public webpage.
The workshop will be held at the FTC’s Constitution Center Conference Center, 400 7th St., SW, Washington, DC 20024. The Commission will publish a detailed agenda at a later date. The Commission vote approving the Federal Register notice announcing the workshop was 2-0.
The Federal Trade Commission works to promote competition, and protect and educate consumers. You can learn more about consumer topics and file a consumer complaint online or by calling 1-877-FTC-HELP (382-4357). Like the FTC on Facebook(link is external), follow us on Twitter(link is external), read our blogs and subscribe to press releases for the latest FTC news and resources.Read more
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