FTC issues 10-year Eyeglass Rule update as AOA renews demand for crackdown on medical device scammers

Federal regulators abandon a pair of harmful proposals in the newly released Eyeglass Rule update after the AOA’s decade-long efforts to moderate the agency’s approach to small- and mid-sized health care practices. 

On June 27, the Federal Trade Commission (FTC) announced final updates to its Ophthalmic Practice Rules, commonly known as the Eyeglass Rule, to take effect 60 days after publication in the Federal Register. In turn, the AOA announced it will soon provide member doctors compliance tools and guidance with a goal of easing burdens associated with the FTC’s rule update, as well as renew its work with the commission and other federal enforcement agencies to spur a crackdown on illegal medical device sales and internet scams. 

“Too many officials and agencies remain out of touch with what we face every day in our practices, and the result can be an emboldened bureaucracy and schemes for burdensome new mandates,” says AOA President Steven T. Reed, O.D. “Our AOA will never stop fighting to change that and to stand up for the doctor-patient relationship as the foundation of optometry’s essential and expanding role in health care.” 

FTC issues Eyeglass Rule update after 10-year review 

Among the revisions set forth by the final rule are specific requirements on doctors of optometry and ophthalmologists that mirror those of the 2020 Fairness to Contact Lens Consumer Act (FCLCA) related to contact lens prescription release confirmation, namely: 

• Doctors are required to obtain patient confirmation after eyeglass prescription release.
  
• Doctors can choose to provide the prescription electronically, if the patient consents to electronic delivery. If a doctor already asks patients whether they would like their contact lens prescription electronically, the same form may be used to obtain consent for electronic delivery of the eyeglass prescription.
  
• Obtaining consent for electronic delivery does not need to be complete at each visit. Allowing patients to sign an authorization just once would satisfy the rule’s requirements. However, if the doctor changes their digital delivery policies (e.g., by switching from email delivery of prescriptions to access on a portal), the doctor would need to re-obtain the patient’s digital delivery consent. Additionally, doctors should allow a patient to revoke consent at any time.
  
• Consent must specify the method that the prescription will be delivered (e.g., whether via email, portal or another option).
  
• If the doctor provides a prescription on paper, a separate signed form, receipt or prescription copy must be signed by the patient.
  
• Prescribers must maintain records or evidence of a patient’s affirmative consent for at least three years. 

Of note, the FTC amended the term “eye examination” to “refractive eye examination” throughout the rule. The FTC made this change because it believed there was physician and patient confusion surrounding when a prescription can be withheld due to lack of payment. The FTC indicates this terminology change will help prescribers understand that while they may withhold the prescription pending receipt of payment for the refraction, it is not appropriate to make prescription-release contingent upon the payment for any additional service. 

However, despite the new prescription release and retention requirements, the FTC did heed the AOA’s advisement to not move forward with extreme new changes, including: 

• Requiring pupillary distance to be added to eyeglasses prescriptions.
  
• Implementing a new prescription verification system altogether.

According to the FTC’s June 27 announcement, “Despite the rule’s longstanding existence, prescribers have not always complied with the automatic release requirement. In response to consumer complaints over the past several years, the FTC has sent warning letters to prescribers reminding them that they must provide patients with prescriptions at the end of an exam and cannot charge a fee or require eyeglass purchase for prescription release. But even so, surveys of consumers have repeatedly found that many consumers do not automatically receive their prescription following each refractive eye exam.” 

The AOA, which has repeatedly disputed such assertions and been critical of policymakers who rely on anecdotes, cited a range of doctor, consumer and marketplace research and surveys as evidence of widespread full compliance. 

AOA details exceeding efforts to inform FTC decision 

Ever since the FTC proposed changes to the Eyeglass Rule in 2015, the AOA has consistently and proactively communicated with the FTC to provide data, information and experiences from the front lines of patient care on how new paperwork requirements continue to add burden to optometry practices. 

In total, the AOA’s inquiries, official replies, reports, data submissions and official agency contacts come to 133 in the final rule. This far exceeds those submitted by 1-800 CONTACTS (33), the American Academy of Ophthalmology (22) and the National Association of Retail Optical Companies (55). 

⏩ Read AOA doctors’ testimony at the May 2023 FTC Eyeglass Rule workshop. 

⏩ Read AOA’s case against FTC rule changes on prescription requirements. 

⏩ Read about AOA’s meeting with officials to voice concerns regarding such proposals. 

AOA urges crackdown on internet scammers, illegal medical device sales 

Notably, one commissioner, Rebecca Kelly Slaughter, issued a statement citing an anonymous consumer complaint as justification for the rule update and hinting at continuing efforts she intends to lead aimed at undermining the medical device status of contact lenses. 

“Being able to have a prescription in your hands as soon as your examination is done would be very beneficial to a lot of people for many reasons,” wrote the anonymous consumer, describing an encounter in which a prescriber charging “outrageous” prices made it difficult for the commenter to obtain their prescription. “It shouldn’t be a hassle for someone to get their prescription, after all it is your prescription, and you shouldn’t have to pay extra for it.” 

Commissioner Slaughter observed: “Eyeglasses, like contact lenses, are the stuff of everyday life and kitchen-table budgeting. The rulemaking record underscores how important the prescription-release requirement is to budget-conscious consumers, too many of whom have not benefited from it, even though it has been the law since 1978. The updated rule will help ensure that consumers actually get their prescriptions and can shop around for what works best for them.” 

Yet with the rule change, the AOA issued a renewed call for a government enforcement agency crackdown targeting illegal medical device sales and internet scammers, increasing numbers of which are being identified through reports submitted by doctors to the AOA via the website and StopIllegalCLs@aoa.org.  

"The FTC and other government agencies can and must do much more to protect the public from internet scammers and illegal medical device sales,” Dr. Reed says. “The AOA will continue working to expose threats to the health and safety of our patients and fully enforce federal and state consumer protection laws.” 

The rule is expected to take effect in September 2024 with the AOA providing further resources and guidance to support compliance of the rule soon. 

Advocating for optometry and patient safety 

The AOA is an advocacy force in Washington, D.C., ensuring optometry is recognized and heeded on health care policy issues impacting practices, patients and public health. Help the AOA keep illegal or unsafe sellers accountable by: 

• Reporting a website illegally selling contact lenses, eyeglasses or eye care devices.
  
• Emailing de-identified case reports with your state of practice to StopIllegalCLs@aoa.org to bolster AOA’s advocacy against illegal eyeglasses or eyecare device sales, as well as harmful contact lens practices. 

Questions about compliance and the new rule can be directed to askaoa@aoa.org.