Identifying The Issues: Key Eye Health Issues

Consumers and the Contact Lens

Contact lenses are worn by millions of people and purchased through a variety of retail channels, but they aren’t everyday consumer products.
Contact lenses are complex medical devices that interact directly with the surface of the eye—but they can be worn with minimal risk with proper oversight by a medical professional.
The U.S. government and state medical boards oversee the prescribing, sale, and use of contact lenses to help ensure patients’ eye health, vision safety, and continued access to lenses.

What you’ll learn

What You’ll Learn

This module will review the laws that guide the safe and accessible use of contact lenses, and the specific issues facing practices, patients, and providers. After completing this module, you should be more familiar with:

Contact Lenses and the Law

Contact Lenses as Medical Devices

Contact Lens Brand Substitution

Contact Lens Prescription Expiration

Quantity Limits

Online Contact Lens Prescribing and Telemedicine

Verifying Contact Lens Prescription

It will also provide tools and suggestions for how you can effectively communicate with your colleagues, your patients, and policy makers about the issues that matter to you most.

The Rules of the Road

Rules of the Road

How Contact Lenses
are Actually “Governed”

The U.S. Congress gives two government agencies the authority to manage the safe use and access to contact lenses based on the issues they cover: The Food and Drug Administration (FDA) and the Federal Trade Commission (FTC). When Congress passes laws that impact contact lenses, they are then implemented and enforced by the FDA and the FTC.

The FDA helps to make sure that medicine and medical devices in the U.S. are safe and effective for patients who need them. FDA classifies contact lenses as Class II or Class III medical devices because they pose a higher risk to patient vision health without appropriate oversight from an eye care professional.

The FTC monitors and enforces consumer protections in the U.S. As part of that role, FTC oversees aspects of contact lens consumer issues on brand name, the process used by contact lens sellers to verify prescriptions, and prescription renewal requirements.

FDA's Role

Contact Lenses are Medical Devices

In 1976, the U.S. Congress recognized a clear need for a review process to ensure the safety of medical devices like contact lenses, and passed the Medical Device Amendments (MDA).

This law gives the FDA the authority to oversee the safety and efficacy of lenses, as well as classify contact lenses. The FDA has continued to classify contact lenses as Class II and III medical devices—meaning they pose a moderate to higher risk to patient eye health and safety when worn without appropriate oversight from an eye care professional.

Daily wear contact lenses are recognized as Class II devices. Other devices in this category include things like infusion pumps and hearing aids.

Extended wear contact lenses are recognized as Class III devices. Other Class III devices include things like dental implants and heart valves.

FTC's Role

Fairness to Contact Lens Consumers

Over 10 years ago, Congress passed the Fairness to Contact Lens Consumers Act of 2003 (FCLCA), which guides consumers’ safe access to their lenses. Some examples of key provisions in the FCLCA include:

Prescribers must provide consumers with a copy of their contact lens prescription after an exam and fitting with an eye care professional.

Sellers must verify the prescription with the contact lens prescriber before dispensing the order to the consumer.

The FTC implemented the FCLCA as the Contact Lens Rule — a rule that aims to balance consumer choice in the marketplace with the FDA’s patient health and safety protections.
The Contact Lens Rule undergoes a regularly scheduled 10-year review to account for any changes that should be made to keep the rule up-to-date with the demands of patients and the market. In October 2015, the FTC initiated its first 10-year review of the Contact Lens Rule—since then, the Rule remains under review and is pending finalization.

States’ Authority

States' Authority

Building on the Federal Framework

The federal government plays a central role in establishing the framework for our contact lens marketplace, but our existing rules defer to the states on several provisions—providing them with the authority to enact their own related policies.

For example, Congress and the FTC sets a federal minimum (or floor) contact lens prescription expiration date of one year; however, a number of states—like Florida, Minnesota, and New Mexico—have extended their contact lens prescription expiration dates to two or three years.

Contact Lenses and the Law

The Bottom Line

Contact Lenses Are Medical Devices

In 1976, the U.S. Congress recognized a clear need for a review process to ensure the safety of medical devices like contact lenses, and passed the Medical Device Amendments (MDA).

Daily wear contact lenses are recognized as Class II devices. Other devices in this category include things like infusion pumps and hearing aids.

Extended wear contact lenses are recognized as Class III devices. Other Class III devices include things like dental implants and heart valves.

Today’s Reality

Contact Lenses are More Advanced Than Ever

Contact lenses are a lot different than the earliest modern lenses from over fifty years ago.Today, more than 160 brands of contact lenses are available to patients and their eye care providers—each with about 10 unique structural and chemical features to address individual patient eye health needs.
However, as the contact lens marketplace evolves and consumers have more choices in where to conveniently buy their lenses — a range of potential complications to patient eye health and safety remain.

The
Takeaway

As contact lens manufacturers continue to innovate new lenses, it is more important than ever to maintain their current classification as medical devices to support their safety and effectiveness.

Pathways to Add Your Voice

Your elected officials must hear from real vision care advocates like you to understand why it’s critical to protect contact lenses as Class II and III medical devices that require oversight from an eye care professional.

An easy activation plan

Join other vision care advocates:
Optometry associations help educate and organize vision care advocates to act on the issues today that matter most to them. They provide advocates with the resources they need to stay up-to-date and involved on state and federal proposals that would impact vision care. Learn more about some of these organization below.

The American Optometric Association (AOA)

The American Optometric Student Association (AOSA)
Lend your voice to legislators
You can find information about your state and elected officials, as well as how to reach them here by using one simple tool. Click here to locate your legislators.

Write them a brief letter or email message

Make a phone call to their office

Memorable Messages

Speak up for patient safety

Contact lenses are not consumer products — they are regulated in the same way as hearing aids, infusion pumps, or even heart valves—and they require a prescription and appropriate supervision from an eye care professional.
Contact lenses have more than 10 chemical and structural features — and each brand is different. As a result, eye care professionals have a range of options to find the right fit for each patient’s vision care needs based on a comprehensive exam and lens trial period.
Contact lenses must continue to be monitored as Class II and III medical devices to ensure they can be used safely by millions of people every day.

The Bottom Line

Contact lenses are not Interchangeable

The Federal Trade Commission’s (FTC) Contact Lens Rule prohibits contact lens sellers from substituting a contact lens brand not included on a patient’s prescription. This rule helps to ensure that patients will receive the exact lenses prescribed to them by their eye care provider, regardless of where they choose to purchase. In its recent 10-year review of the Contact Lens Rule, the FTC proposed to maintain this requirement for non-substitution.

What Does This Really Mean?

Sellers may not substitute another manufacturer’s brand of lenses. Only an eye care provider can prescribe the right brand of lenses for a contact lens patient.
Sellers are permitted to substitute for private label lenses — if they are made by the same manufacturer, but sold under another name.

Today’s Reality

Ensuring safety from all retail channels

Patients have more options than ever in how and where to purchase their prescribed lenses—including online, in a retail store, or through their eye care provider. However, with growing choice in the marketplace, it’s more important than ever to ensure patients can feel confident in receiving the exact lenses prescribed by their eye care provider. Unfortunately, this isn’t always the case.

How does substitution play out in today’s contact lens marketplace?

In a survey of online contact lens wearers, one-in-four (24 percent) reported receiving without warning, a different brand of contact lenses than what they ordered.^*
In the same survey, three-in-ten (31 percent) of retailers advised online contact lens consumers to purchase another brand of contact lenses due to supply issues.^*

The
Takeaway

Consumers should have convenient, efficient access to the contact lenses they need, but never at the expense of eye health.

* APCO Insight September 24 – October 2, 2015 online survey among adult contact lens consumers 18 years of age or older who have purchased contacts online in the last six months on behalf of Johnson & Johnson Vision.

* Ibid

Pathways to Add Your Voice

Your elected officials must hear from real vision care advocates like you to understand why it’s critical that patients receive the exact contact lenses prescribed by their eye care provider.

An easy activation plan

Join other vision care advocates:
Optometry associations help educate and organize vision care advocates to act on the issues today that matter most to them. They provide advocates with the resources they need to stay up-to-date and involved on state and federal proposals that would impact vision care. Learn more about some of these organization below.

The American Optometric Association (AOA)

The American Optometric Student Association (AOSA)
Lend your voice to legislators
You can find information about your state and elected officials, as well as how to reach them here by using one simple tool. Click here to locate your legislators.

Write them a brief letter or email message

Make a phone call to their office

Role of an Eye Care Provider

Speak up for the important role of eye care providers

Eye care professionals evaluate and work closely with their patients to find the most compatible, safe, and effective lenses.
There are more than 160 different brands of contact lenses on the market today and each brand’s proprietary material can cause different patient reactions.
Following a comprehensive eye exam, the eye care professional may have a patient try on several brands during a diagnostic fitting to determine which brand’s formula is best suited for that patient’s eyes.

Memorable Messages: Patient Safety

Memorable Messages

Speak up for patient safety

94 percent of online consumers agree it is important to them to that they receive the exact brand of lenses they were prescribed.^*
Substituting a non-prescribed contact lens brand can put patients’ eye health at risk. Unlike prescription drugs, contact lenses cannot be substituted for a non-prescribed or generic equivalent, as each brand is unique to each manufacturer and designed to suit a different set of vision needs.
Patients can experience potentially serious and lasting eye damage from wearing a non-prescribed brand.

*APCO Insight September 24 – October 2, 2015 online survey among adult contact lens consumers 18 years of age or older who have purchased contacts online in the last six months on behalf of Johnson & Johnson Vison Care, Inc.

From The Field

Real stories, real impact

The most effective way to make a lasting impact on a policymaker or their staff is to provide a real example from the field to highlight the importance of ensuring patients receive the exact lenses that were prescribed to them by an eye care professional.

Your story may be the difference that inspires a lawmaker to get involved and take action on vision care issues.

The Bottom Line

Limitations and patient safety

Congress’ 2003 Fairness to Contact Lens Consumers Act and the Federal Trade Commission’s (FTC) 2004 Contact Lens Rule established a one-year minimum (or floor) contact lens prescription expiration date. In its 10-year review of the Rule, FTC proposed to maintain the one-year minimum prescription expiration date—underscoring the importance of regular vision care and updated contact lens prescriptions.

Today’s Reality

Pushing the limit

The Rule gives states the authority to enact their own contact lens prescription expiration limits, as long as they aren’t below the federal floor of one year. In response, several states, from Florida to New Mexico, have extended their state prescription expiration limits beyond one-year — which, in turn, extends the time between regular visits to an eye care professional and potentially increases the risk to contact lens patients’ health and safety.

Arizona in Focus

arizona map In 2016, the Arizona General Assembly introduced House Bill 2523, legislation that would extend the life of a contact lens prescription up to three years. This initiative was defeated as a result of individual eye care providers—and the Arizona Optometric Association—who successfully conveyed how regular comprehensive exams mean healthy eyes for contact lens patients.

The
Takeaway

It is likely that as the contact lens marketplace evolves, supporters of extending contact lens prescription expiration dates will continue to introduce similar legislative initiatives to House Bill 2523.

Pathways to Add Your Voice

Your elected officials must hear from real vision care advocates like you to understand why it’s critical to support safeguards like the one-year expiration date on contact lens prescriptions.

An easy activation plan

Join other vision care advocates:
Optometry associations help educate and organize vision care advocates to act on the issues today that matter most to them. They provide advocates with the resources they need to stay up-to-date and involved on state and federal proposals that would impact vision care. Learn more about some of these organization below.

The American Optometric Association (AOA)

The American Optometric Student Association (AOSA)
Lend your voice to legislators
You can find information about your state and elected officials, as well as how to reach them here by using one simple tool. Click here to locate your legislators.

Write them a brief letter or email message

Make a phone call to their office

Memorable Message

Speak up for patient safety

The life of a contact lens prescription should not undermine the medically-recommended one year contact lens prescription expiration limit.
More than 99 percent of respondents in a Centers for Disease Control and Prevention (CDC) survey reported at least one risky contact lens behavior. Regular physician oversight supports patient education and helps to minimize the risks associated with contact lens wear.^*
Today, 97 percent of consumers agree that it is important to regularly visit the eye doctor to ensure they have the correct prescription to meet their vision care needs.^**
Patients’ physiological response and vision abilities change over time. In fact, 94 percent of online contact lens wearers reported that their prescription had changed since their last annual visit.^***

*https://www.cdc.gov/media/releases/2015/p0820-contact-lens.html

**APCO Insight August 2015 telephone survey among adult contact lens consumers 18 years and older on behalf of Johnson & Johnson Vison.

***APCO Insight September 24 – October 2, 2015 online survey among adult contact lens consumers 18 years of age or older who have purchased contacts online in the last six months on behalf of Johnson & Johnson Vison.

From the Field

Real stories, real impact

Your story may be the difference that inspires a lawmaker to get involved and take action on vision care issues.

The Bottom Line

Limitless lenses

Although Congress’ 2003 Fairness to Contact Lens Consumers Act and the Federal Trade Commission’s (FTC) 2004 Contact Lens Rule requires that contact lens sellers provide for prescribers the quantity of contact lenses ordered when they verify a prescription—there is actually no quantity limit (or a maximum) number of contacts a patient may purchase per individual prescription. In its 10-year review of the Rule, the FTC decided to maintain the requirement that quantity be included on contact lens orders, but did not choose to add any limitations or restrictions on the amount of lenses that can be purchased.

The FTC requires sellers to provide the quantity of lenses ordered as part of prescription verification requests. In doing so, the FTC has shared that it intended this information to help ensure consumers didn’t order an excessive amount of lenses.

Today’s Reality

Stretching prescriptions

With so many choices of where to purchase contact lenses in today’s marketplace, striking the right balance between convenience and eye health can potentially undermine what’s best for patient safety.

How do contact lens quantity and safety play out in today’s marketplace?

Nearly six-in-ten or 58 percent of online consumers say they have received an email or letter from their retailer reminding them their Rx was expiring soon, and the majority who received this notice— 86 percent—ordered more contact lenses at that time to stretch out their prescriptions for more time. ^*
Unfortunately, 1 in five online contact lens patients did so after their prescription had already expired—putting their eye health and safety at risk. ^*

The
Takeaway

The reality of today’s marketplace is that the current contact lens prescription verification process does not provide adequate safeguards—and the ability to stretch out prescriptions and order excessive lenses puts patient eye health and safety at risk, and also undermines the value of routine vision care.

How to Report Evidence of Harm to Federal Agencies

* APCO Insight August 2015 telephone survey among adult contact lens consumers 18 years and older on behalf of Johnson & Johnson Vison, Inc.

* Ibid.

Pathways to Add Your Voice

Your elected officials must hear from real vision care advocates like you to understand why it’s time to make slight modifications to modernize the prescription verification process to better protect patient health and safety in today’s contact lens marketplace.

An easy activation plan

Join other vision care advocates:
Optometry associations help educate and organize vision care advocates to act on the issues today that matter most to them. They provide advocates with the resources they need to stay up-to-date and involved on state and federal proposals that would impact vision care. Learn more about some of these organization below.

The American Optometric Association (AOA)

The American Optometric Student Association (AOSA)
Lend your voice to legislators
You can find information about your state and elected officials, as well as how to reach them here by using one simple tool. Click here to locate your legislators.

Write them a brief letter or email message

Make a phone call to their office

Memorable Messages

Speak up for patient safety

The life of a contact lens prescription should not undermine the medically-recommended one year contact lens prescription expiration limit.
More than 99 percent of respondents in a Centers for Disease Control and Prevention (CDC) survey reported at least one risky contact lens behavior. Regular physician oversight supports patient education and helps to minimize the risks associated with contact lens wear.^*
Today, 97 percent of consumers agree that it is important to regularly visit the eye doctor to ensure they have the correct prescription to meet their vision care needs.^**
Patients’ physiological response and vision abilities change over time. In fact, 94 percent of online contact lens wearers reported that their prescription had changed since their last annual visit.^***

*https://www.cdc.gov/media/releases/2015/p0820-contact-lens.html

**APCO Insight August 2015 telephone survey among adult contact lens consumers 18 years and older on behalf of Johnson & Johnson Vison, Inc.

From the field

From The Field

Real stories, real impact

Your story may be the difference that inspires a lawmaker to get involved and take action on vision care issues.

Online Contact Lens Prescribing and Telemedicine

Our Changing World

Digital medicine

The world around us is increasingly digital—and more and more, we can access what we need online: including medical care. Telemedicine is the ability to remotely diagnose and provide treatment plans to patients through technology. Telemedicine offers pathways for people to access medical care more efficiently, and has the potential to contribute to significant savings to our health care system.

Telemedicine is in the early stages of being more widely accepted and implemented. For example, many bills have been introduced in Congress to allow for telemedicine diagnosis and treatment of certain diseases or conditions—particularly those which may not require an in-person exam. However, most of these bills haven’t been passed and turned into laws—and the majority of telemedicine initiatives are small pilot programs to test how the idea works for real people in practice.

Telemedicine and Contact Lenses

A role for the states

The FDA classifies contact lenses as medical devices that require a prescription from an eye care professional, but the states can determine who qualifies as a licensed prescriber in that state and how and where they may prescribe medicines or medical devices. New technologies may offer the option for contact lens prescribing following an online refractive test (or even just a simple online questionnaire), rather than a comprehensive exam—the current standard of care. The states have started to take up this issue and it’s likely that this is just the beginning of a bigger trend to come.

Today’s Reality

A refractive test is not a comprehensive eye exam

Recently several states have introduced bills that would allow for contact lenses to be prescribed on the basis of an online refractive test — separating this individual test from a comprehensive exam.

On the other hand, there have also been state efforts to uphold the current standard of care, which includes a range of tests and a diagnostic fitting, to ensure patients’ eyes are healthy enough to wear lenses and to determine the right prescription.

A Focus on the States in 2017

The beginning of the online prescribing debate

Indiana: In 2017, the Indiana General Assembly introduced House Bill 1331, which would also allow for the use of online telemedicine to prescribe contact lenses. Thanks to eye care providers throughout the state who organized in opposition to the dangers posed by House Bill 1331 — it was defeated.

Virginia: In 2017, the Virginia General Assembly passed legislation, which would take valuable steps to protect contact lens patient health and safety by clarifying that contact lens patients receive the same high standard that they receive in a provider’s office—no matter how or where they choose to receive it.

New Mexico: In 2017, the New Mexico Legislature passed legislation that recognizes the importance of having regular, comprehensive, face-to-face exams to protect patient eye health and vision safety. Governor Susana Martinez vetoed the bill.

The
Takeaway

Telemedicine has the potential to promote better access to quality care. However, a refractive test alone should not be separated from a comprehensive eye exam. A single assessment, including a refractive test, is insufficient in helping doctors best determine a contact lens prescription and whether a patient’s eyes are healthy enough to wear contact lenses.

Pathways to Add Your Voice

An easy activation plan

Join other vision care advocates:
Optometry associations help educate and organize vision care advocates to act on the issues today that matter most to them. They provide advocates with the resources they need to stay up-to-date and involved on state and federal proposals that would impact vision care. Learn more about some of these organization below.

The American Optometric Association (AOA)

The American Optometric Student Association (AOSA)
Lend your voice to legislators
You can find information about your state and elected officials, as well as how to reach them here by using one simple tool. Click here to locate your legislators.

Write them a brief letter or email message

Make a phone call to their office

Memorable Messages

Speak up for patient safety

Both the FDA and the Centers for Disease Control and Prevention (CDC) recommend undergoing regular, in-person eye exams. This is the current standard of care for contact lens prescribing.
When patients undergo their regular, comprehensive, face-to-face exams to determine their prescriptions and overall eye health needs, their doctors are not just assessing the necessary refractive power to bring their vision to 20/20 — they are also reviewing patients’ specific physiological responses to each lens brand’s proprietary formula, in conjunction with their unique set of ocular and systemic health conditions, for example, diabetes or cancer.
Current online refractive technology is significantly limited and—even if improved—would remain an incomplete evaluation of all the factors and conditions needed to diagnose and determine a contact lens patient’s eye health needs, consistent with the current standard of care.

From The Field

Real stories, real impact

Your story may be the difference that inspires a lawmaker to get involved and take action on vision care issues.

The Bottom Line

Verifying contact lens prescriptions

Congress’ Fairness to Contact Lens Consumers Act and the Federal Trade Commission’s (FTC) Contact Lens Rule requires sellers to verify consumers’ prescription with their eye care provider prior to dispensing contact lenses to ensure patients receive the exact lenses prescribed, regardless of where they choose to purchase.

What does this really mean?

Prescribers have an eight-hour window to respond to sellers’ prescription verification requests to verify the prescription or address inaccuracies, before the prescription is automatically verified.
Congress and the FTC enacted this process in response to concerns that patients were unable to effectively access their prescriptions and have choice in where to purchase their lenses.
However, in practice, the current verification process allows sellers to choose from a range of options to contact prescribers for verification—including outdated communication like fax and “robocalls,” which often take place after hours or without return numbers.
This process, as it currently stands in the Contact Lens Rule, is increasingly allowing contact lenses to be dispensed to patients without prescriber verification.

Today’s Reality

The problem with today's verification process

When the Contact Lens Rule was first implemented over a decade ago, our contact lens landscape looked a bit different. Not only were there far fewer and less advanced ways to communicate, but consumers were also limited in their choices of where to purchase their lenses.

Fast-forward to today, and patients have more options than ever in where to fill their prescriptions and communications technology has significantly changed. And while there are many benefits to the way the marketplace has evolved, there also continue to be reports from patients, sellers, and prescribers on how the careful balance has potentially shifted away from what’s best for patients’ eye health and vision safety. Today, due to challenges with the outdated verification process, it’s possible to order lenses based on an expired prescription, stockpile lenses from the same prescription for years, or inadvertently receive duplicate orders.

Legislative Solution

Modernizing the FCLCA

In response to these concerns, vision care advocates have worked with key allies in Congress to find ways of modernizing the Fairness to Contact Lens Consumers Act of 2003 to better reflect today’s environment.

In April 2016, the Contact Lens Consumer Health Protection Act (CLCHPA) was first introduced in the U.S. Senate as a preliminary way to address some of the issues consumers and providers experienced in the marketplace, including challenges with the current prescription verification process. Companion legislation was later introduced in September 2016, in the U.S. House of Representatives.

This bill would make small, but necessary updates to the existing contact lens prescription verification process — and help to ensure prescribers and sellers can better communicate and work together to verify patients’ prescriptions, promote consumer access, and protect patient vision safety.

Unfortunately, Congress adjourned in 2016 without taking a vote on this bill — but vision care advocates are already working with Members of Congress to find new ways to address some of these ongoing challenges.

The
Takeaway

The current prescription verification process is unfortunately not working as the Federal Trade Commission (FTC) and Congress intended. The verification process must be updated to ensure patient eye health and safety.

Pathways to Add Your Voice

An easy activation plan

Join other vision care advocates:
Optometry associations help educate and organize vision care advocates to act on the issues today that matter most to them. They provide advocates with the resources they need to stay up-to-date and involved on state and federal proposals that would impact vision care. Learn more about some of these organization below.

The American Optometric Association (AOA)

The American Optometric Student Association (AOSA)
Lend your voice to legislators
You can find information about your state and elected officials, as well as how to reach them here by using one simple tool. Click here to locate your legislators.

Write them a brief letter or email message

Make a phone call to their office

Memorable Messages

Speak up for patient safety

Under today’s prescription verification system, patients could order contacts based on an expired prescription even though 94% of contact lens wearers' prescriptions have changed since their last annual visit.
Each contact lens brand is designed to address specific vision needs, so substituting non-prescribed brands can risk patients’ eye health if the substituted lenses do not match what the patient needs.

From The Field

Real stories, real impact

Your story may be the difference that inspires a lawmaker to get involved and take action on vision care issues.

Tools for Vision Care Advocacy

Understanding and communicating about contact lenses as medical devices—that must be prescribed by an eye care professional.

A History of Contact Lens Innovation

While the first contact lens dates back over 500 years, the modern lenses worn today by nearly 44 million Americans only came into existence in the 1950s.

Contact Lenses are Medical Devices

The U.S. Food and Drug Administration (FDA) has recognized contact lenses as Class II and III medical devices since 1976.

An eye care provider’s oversight is so important in the prescribing of Class II and III medical devices—including contact lenses.

The Patient Journey

Contact lenses are federally regulated medical devices that require a prescription for purchase, which is why a contact lens patient’s journey begins in an eye doctor’s office.

Tools for Vision Care Advocacy Part 2

Understanding and communicating about the Fairness to Contact Lens Consumers Act (FCLCA), the Contact Lens Rule, and choice and competition in today’s contact lens marketplace.

Identifying The Issues: Key Eye Health Issues

KEEP AN EYE ON THE ISSUES