(ARLINGTON, VA) – The Health Care Alliance for Patient Safety (Alliance) will hold a congressional briefing on Tuesday, April 24, 2018, from Noon-1 p.m. in The Rayburn House Office Building, Room 2247, to discuss the importance of protecting the safety of patients who use contact lenses, which are regulated medical devices.
Attendees at the briefing will include vision care professionals, congressional staff and Alliance champions.
The briefing will include a panel that focuses on four key areas:
- Maintaining a strong doctor-patient relationship when it comes to contact lens prescriptions, especially with the emergence of dangerous, abusive or harmful medical device marketing practices that increase patients’ risk for harm.
- The importance of the safe, healthy and effective use of medical devices, including contact lenses, while discussing advancements in technology to create better patient outcomes.
- The recognition of the inviolability of a patient’s prescription, determined through consultation between a patient and his or her doctor.
- Regulatory enforcement and strengthening of patient health and safety rules and laws.
The panel will be moderated by Alliance Chair Deanna Alexander, O.D. The panelists will include:
- Michele L. Andrews, OD – CooperVision, Senior Director, North America Professional and Academic Affairs
- Carol L. Alexander, OD – Johnson & Johnson Vision, Director, Professional Education and Development
- Jeff Sonsino, OD – American Optometric Association, Past- President of Contact Lens & Cornea Section; Private Practice, Nashville, TN
Congressional briefing details are as follows:
Tuesday, April 24, 2018
Noon: Health Care Alliance for Patient Safety holds Congressional Briefing on Safety of Contact Lenses as Regulated Medical Devices
The Rayburn House Office Building – Room 2247
45 Independence Ave., SW
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
On February 14, 2018, the Senate Commerce, Science, and Transportation Committee held the Federal Trade Commission Nominees Confirmation Hearing for the Federal Trade Commission (FTC) nominees: Rohit Chopra, Noah Phillips, Christine Wilson, and Joseph Simons, who was nominated to be the commission’s chair. The nominees provided testimony on a range of issues, including antitrust laws, prescription drug pricing, credit rating agencies, and the expansive influence of big tech companies like Google and Facebook.
This clip features Senator Roger Wicker (R-MS) questioning the nominees on modifications to the Contact Lens Rule currently under consideration by the FTC.Read more
The Health Care Alliance for Patient Safety is pleased to learn that the Food and Drug Administration (FDA) has notified Opternative that their online eye examination is in violation of the Federal Food, Drug, and Cosmetic Act. Though APS supports the development of telehealth to offer better access to Americans, this action by the FDA further demonstrates that online applications cannot currently replace the benefit a patient receives from an in-person, comprehensive eye exam.
Our Alliance and member organizations – which include the American Optometric Association (AOA), Johnson & Johnson Vision, and CooperVision – will continue to advocate for policies that increase patient safety, promote access to quality health care and protect the doctor-patient relationship.Read more
Johnson & Johnson Vision President for North America, Peter Menziuso, provides his company's perspective on how the contact lens rule can continue to provide benefits to patients and promote the safe use of contact lenses.Read more
In December of 2016, during the final days of the Obama administration, the Federal Trade Commission proposed a new regulation that would force eye doctors with small practices, like ones across West Virginia, to require all contact lens-wearing patients to sign an “acknowledgment form.”Read more
FRANKFORT, Ky. (WTVQ) — Online eye exams and prescriptions offered in Kentucky would require a real-time visit with a Kentucky eye care provider under a bill approved today in the House.
House Bill 191 sponsor Rep. Jim Gooch, R-Providence, said the bill is a patient protection measure. It was filed in response to a rise in online companies that allow individuals to get eye exams and prescriptions based on virtual eye exams taken with cell phone or computer apps.
Gooch said HB 191 would not prohibit the use of “safe technology” for online eye care in Kentucky, but would improve on it by requiring a “simultaneous,” or real-time, interaction between consumers and Kentucky-licensed optometrists or physicians who would then have to sign off on the prescription. The bill would also require someone seeking an online eye exam or prescription to have had an in-person eye exam within the previous 24 months, among other requirements.
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: email@example.com(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
Some 45 million Americans depend on contact lenses to correct their vision, and while contacts are very safe overall, not caring for them properly can lead to serious eye infections, health experts warn.Read more
A judge has dismissed Opternative's suit against South Carolina's Eye Care Consumer Protection Law, which specifically bans ocular telehealth. Several states are mulling legislation on telemedicine for eye exams.Read more