Following four years of review and thousands of public comments, the Federal Trade Commission (FTC) recently voted to amend the Contact Lens Rule—referred to as the Final Rule—which “facilitates shopping for contact lenses by requiring prescribers to automatically provide a copy of a patient’s prescription to the patient and to verify or provide prescriptions to third-party sellers.”¹

Prescribers will also need to request patients’ confirmation that they received their prescription, but the Final Rule provides some flexibility in the way the prescription and confirmation are provided, the FTC claims.¹

From 2015-2019, the FTC hammered out the Final Rule by considering public input, surveys, studies, analyses and other information about the evolving contact lens marketplace.

Under the Final Rule, prescribers will be required to do one of the following actions to confirm a patient received their prescription following a CL fitting:

• Ask the patient to acknowledge the receipt of the contact lens prescription by signing a separate confirmation statement.
• Ask the patient to sign a prescriber-retained copy of the prescription that contains a statement confirming the patient received it.
• The prescriber can request the patient sign a prescriber-retained copy of the sales receipt for the exam that contains a statement confirming the patient received the prescription.
• The prescriber can give the patient a digital copy of the prescription and retain evidence it was sent, received, or made accessible, downloadable and printable.

For Professionals, An Extra Burden

While the update was expected, as it’s been in the works since 2015, the timing of the decision in light of COVID-19 is disappointing, says optometrist Brian Chou of San Diego.

Currently, most optometrists are navigating through a dramatically different practice landscape due to the pandemic, including increased administrative burdens with PPP loan accounting, greater costs for PPE and cleaning, re-staffing issues, additional time spent for safety measures and slowing schedules to enhance physical distancing, he says.

“It would’ve been nice if the FTC displayed greater awareness of the COVID-19 fallout on optometric practices by giving more lead time for implementation of these updates. The FTC definitely lost points with me by their insensitive timing,” Dr. Chou says.

Bring on the Red Tape

Adding another hurdle for prescribers, they now must maintain proof they satisfied the confirmation of the Rx release requirement for at least three years. If a patient refuses to sign a confirmation, prescribers must note this and save the record to prove they are in compliance.¹

The Final Rule adds a new definition of the term “provide to the patient a copy,” which will now allow the prescriber—with the patient’s verifiable consent—to provide a digital copy of the prescription in lieu of a paper one.

When seeking a patient’s consent, doctors will need to tell the patient the specific method of electronic delivery they will use and also retain a record of the patient’s consent for three years. The Final Rule will also require prescribers to give patients or their designated agents an additional copy of their prescriptions on request within 40 business hours.

The Final Rule will put an additional administrative burden on optometric practices’ staff and software, Dr. Chou says.

 “This adds insult to injury during a time when optometric practices are recovering from closure and having to do more work than ever,” he notes. “The ideal scenario is for the FTC to provision adequate time for the various optometric electronic medical records to catch up in development and release software builds that seamlessly document conveyance of contact lens prescriptions to patients. That way, staff don’t need to obtain patient signatures and scan them into document management.”

Unfortunately, EMR development takes time, likely up to 12 months, he adds. 

“I would recommend optometrists let their EMR companies know loud and clear that they need this enhanced functionality ASAP to help reduce the additional administrative burden of the Rule’s update,” he says.

 Still, the FTC ruling has a bright side, Dr. Chou adds, since he believes it may force optometry to reduce its reliance on product sales and shift the profession further toward service. Patients may end up paying less for their disposable contact lenses but more for their service fees in part to subsidize meeting the update’s administrative requirements, he suggests.

New Rules for Sellers

The Final Rule includes several new requirements for sellers as well. To address concerns about such services verifying prescriptions by leaving incomplete or incomprehensible automated telephone messages with prescribers, sellers who use automated telephone messages for verification must do the following:

• Record the entire call and preserve the complete recording.
• Start the call by identifying it as a prescription verification request made in accordance with the Contact Lens Rule.
• Deliver the verification message in a slow and deliberate manner and at a volume that the prescriber can understand.
• Make the message repeatable at the prescriber’s option.

Changes May Confuse Specialty Lens Wearers

 “Since my practice is skewed toward managing keratoconus and eye disease with specialty contact lenses, I am disappointed that the FTC has not yet educated consumers that their intent with this update is to improve competition in the soft disposable contact lens space, not custom medically-indicated lenses,” Dr. Chou says.

The danger is that patients in medically indicated contact lenses for issues such as keratoconus, corneal transplantation and graft-vs.-host disease will mistakenly believe they can purchase their custom lenses through any online retailer and their doctor can readily perform lens exchanges in this manner, he adds.

“Not the case,” Dr. Chou says. “Whether intended or not, the FTC is externalizing onto eye doctor offices the burden of explaining to patients that custom contact lenses cannot be filled through just any contact lens company.” In effect, he explains, the doctor’s office becomes the bearer of bad news, “whereas the FTC could instead be taking the leadership of preemptively educating consumers that medically indicated contact lens designs can only be successfully prescribed when the doctor works directly with the contact lens laboratory to obtain a desirable outcome.”

The AOA Reacts

In a statement, incoming AOA president William T. Reynolds says, “The FTC was wrong four years ago when they first proposed this destructive plan and they’re wrong today in seeking to implement it. More than 100 US Senators and House members—Republicans and Democrats—have joined with the AOA since 2016 to fight back and we will do what it takes to increase this support going forward. This is a completely misguided attack on law-abiding, frontline optometry practices that is made even more outrageous and unacceptable coming at a time when we've been providing essential, primary care to our patients through every stage of the COVID-19 public health emergency.”

 Instead of responding to the pandemic by supporting tens of thousands of small health care practices serving their communities and heeding the Federal directives to ease regulatory burdens, this government agency has chosen to attack doctors and penalize patients with a destructive new paperwork and record-keeping requirement, the AOA noted.

The Rule changes go into effect 60 days after publication in the Federal Register notice. The Contact Lens Rule has been in place since August 2004.