About one year ago, Annette Hanian, OD, and I stood on the steps of the Arizona State Capitol in Phoenix. We were both preparing to testify before the Arizona House of Representatives against a bill that, if successful, would have extended contact lens prescription expiration limits to three years—a decision that would have had significant consequences for patient eye health and vision safety in Arizona…and potentially across the country.

According to Dr. Hanian, Arizona Optometric Association’s Legislation Chair: “All it takes is one state. I felt that from the very beginning of all of this. I just knew that if Arizona lost, it wasn’t just Arizona patients losing—it was patients across the whole country. All you need is one state to establish a precedent. It would have been a disaster. A rolling stone.”

And I believe that Dr. Hanian is right—all it takes is one state.

THE EVOLUTION OF ADVOCACY IN VISION CARE

Change is a constant in our profession. We’ve seen it in our early efforts to provide better access to quality vision care for all of our patients by expanding our scope of practice, fighting for coverage as providers under Medicare, and ensuring children’s eye exams are recognized as an essential health benefit by the Affordable Care Act.

We’ve seen it in our work to promote eye health and safety by including vision objectives in the U.S. Department of Health and Human Services’ (HHS) Healthy People 2010 (HHS, 2000). We’ve seen it as we’ve stood up on behalf of our patients by gaining the right to certify patients’ blindness with the Internal Revenue Service and by serving as commissioned officers in the Armed Services. And we see it today as we continue to protect patient choice and the practitioner-patient relationship through our work with the U.S. Food and Drug Administration (FDA), the Federal Trade Commission (FTC), state legislatures, and on Capitol Hill.

These changes and these accomplishments didn’t occur overnight or by chance. They have meant countless hours of sharing insights and building awareness in our community, donating our time and resources to support organizations that work to advance our positioning, and taking direct action through hundreds upon thousands of letters, calls, and meetings with legislators and regulators. And every single one has been, and continues to be, deeply and inextricably driven by a single north star: our responsibility to the health and safety of our patients, both today and in the years to come.

This responsibility is why most of us, generation after generation, joined the profession—to improve the lives of our patients. It’s also why, as we look ahead, it’s never been more important for all of us to stand together.

Recently, the contact lens industry has experienced unprecedented challenges to eye health and vision safety. Challenges that would impact the future of contact lens safety and innovation. And challenges that—unlike those of the past—provide a unique opportunity for the industry and all providers to join together on behalf of patients.

Over the past few years, we have seen proposals emerge that would allow for the online prescribing of contact lenses, or that would extend prescription expiration limits to three or even five years, and even suggestions that we should permit sellers to freely substitute the brand of lenses. Some of these challenges imply that all of our licensing and extensive training is unnecessary, that no professional oversight is needed, that the structural and biological features that influences a patient’s contact lens prescription are not important, and that one “piece of plastic” is as good as the next—focusing only on what’s cheap and/or what lens stock is available in inventory.

While many in the profession have not yet had to experience these challenges first hand, those in states that have advocated against similar proposals in 2016—such as Arizona and Utah—know all too well that these challenges are real, that they are urgent, and, importantly, that when we stand together in ways we haven’t before, we can ensure that patient safety is protected.

I recently sat down with two colleagues and fellow patient health and safety advocates—Dr. Hanian and David Cockrell, OD, American Optometric Association (AOA) Advocacy Group Chair—to discuss how they see our current legislative environment, what we need to understand as it specifically relates to patient safety with contact lenses, and how can we be best prepared to convey our messages to policy makers.

UNTANGLING “DEREGULATION”

First, when we talk about today’s advocacy or legislative environment, I’ve often heard the term “deregulation” used. While it’s not a new concept, it’s a new term to many within our industry. And, even among those who use it, it isn’t always clear what it means when it comes to how contact lenses are prescribed, bought, and sold. Perhaps that’s because to understand deregulation, we really have to start with regulation.

Since the 1970s, FDA has regulated contact lenses as class II and III devices, which means that they require professional oversight—including an eye examination and prescription—to reduce patients’ risk and ensure that their eyes are healthy enough to wear lenses.

As the number of contact lens wearers continued to grow, the U.S. Congress recognized the need to create additional guidelines for the modern marketplace. So, in 2003, Congress passed the Fairness to Contact Lens Consumers Act (FCLCA). The FCLCA, along with the FTC’s Contact Lens Rule, established:

• A patient’s right to a copy of his or her prescription;
• What details are required on that prescription;
• A process—known as “passive verification”—by which sellers can confirm the accuracy and validity of a patient’s prescription; and
• A minimum contact lens expiration limit of one year.

Still, as Dr. Cockrell noted, “Even with the FCLCA and the FDA’s and FTC’s rules, the sale of contact lenses is not that heavily regulated. Instead, this framework truly created a pathway where contact lens patients can buy their contact lenses on the open market from any place they want to buy them, as long as they have a valid prescription and do so with the professional oversight of their [eyecare provider].”

So when colleagues and other vision care advocates talk about the “deregulation” of the contact lens industry, what they are referring to, in large part, are any efforts aimed at removing those guidelines or weakening the existing framework. To put that into context, Dr. Cockrell shared the following example.

“For instance,” he noted, “some have suggested that we should genericize or unbrand contact lenses. And to many of our patients and to some policy makers, that might sound OK—especially since most of us are familiar with generic medicine. They think, why wouldn’t it work the same?

“But, as all of us [who prescribe contact lenses] know, [contact lenses] don’t all perform the same,” Dr. Cockrell continued. “We know that each brand of contact lens is unique—based on a complex myriad of features, such as material characteristics, water content, curvature, and diameter.”

The challenge is that policy makers often aren’t aware of these complexities. Therefore, on the surface, changes such as allowing for the substitution of non-prescribed or “generic” lenses have been positioned by proponents as a good thing—as doing the same thing that many believe generic medicines did for the pharmaceutical market. That’s why it is so important to have these conversations with policy makers. We need to share and explain why only licensed eyecare professionals can determine the lens best suited to meet the medical and ocular needs of a patient. Without that understanding, the importance of the practitioner-patient relationship is minimized, and policy makers may oversimplify the complex decision-making that leads to a contact lens prescription. Unfortunately, too often, that oversimplification drives the arguments behind contact lens deregulation.

And, it doesn’t stop with the idea of generic lenses. To some, deregulation also means removing or significantly extending expiration limits or eliminating or limiting licensed, professional oversight. In short, Dr. Cockrell summarized, “it’s essentially commoditizing contact lenses—attempting to make them, in many ways, no different than toilet paper or motor oil, rather than treating them as the FDA-regulated class II and III medical devices they are.”

PROTECTING PATIENTS IN ARIZONA

For Dr. Hanian and her colleagues in Arizona, “deregulation” and “commoditization” are more than just words. Last year, in Arizona, they were real challenges.

Dr. Hanian isn’t new to advocacy. Like many of us, she had always felt a calling toward volunteerism, toward helping others, and toward “doing the next thing that had to be done.” And, for Dr. Hanian, that meant advocacy.

“Advocacy just fell into my lap,” she said. “It’s not like I have this political science background or have always wanted to be involved in politics. It was just the next ‘volunteer thing’ that I did.

“At first, I was so intimidated,” she explained. “There were just people far more experienced, people that I thought knew these issues far better. Soon I realized that these conversations with legislators were really the exact same type of conversation that I was having with my patients every single day about eye health and about safety. Over time, it became more comfortable, more familiar.”

But in early 2016, Dr. Hanian found herself in a less familiar position as she prepared to testify before the Arizona State House Health Committee against a bill that would extend Arizona’s current one-year contact lens prescription expiration limit to three years. While obvious to practitioners that this change would have a significant impact on contact lens patients, few Arizona state legislators recognized the risk.

Dr. Hanian recalled that, as she began her testimony, she first asked the committee: How many of you have worn contact lenses? “In response, not a single legislator—not one—raised his or her hand. None of them had ever worn a contact lens in his or her entire life. That was an eye-opener,” she said.

Over the course of the next few weeks, Dr. Hanian and her colleagues began to work to change the course of the legislation. In addition, as medical professionals, they provide their representatives with the information needed to understand the full impact of the bill to patients’ eye health and vision safety.

As they created their arguments, she quickly realized that, “the biggest challenge was that for the last several years educating lawmakers, the health and safety issues associated with contact lenses had never been highlighted in the conversation.

“On top of that,” she continues, “we were also facing a short session and working to undo much of the work that had been done to mischaracterize contact lenses as a commodity. It was a lot of educating and re-educating.”

But because Dr. Hanian and her colleagues had worked for years to build those relationships and establish a strong reputation for the profession with their state representatives, they were able to stop the bill from moving forward.

“It made us realize that the work we are doing now, it’s going to affect us 10, even 20 years from now,” she says. “The education and the relationship-building are continuous. If legislators don’t hear from us about what eye care is and what issues matter most to our patients’ eye health and safety, they are going to hear a different story from someone else. And, as we look ahead, we know that our work is just beginning.”

BUILDING A STRONGER FUTURE

Ultimately, we will all play important roles in building the future of vision care; and one thing is for certain: regardless of your role, advocacy and finding new ways to meet these challenges will be an important part.

Over the last year, eyecare professionals, patient and medical organizations, and manufacturers have worked together with legislators on Capitol Hill and regulators at the FTC to ensure that today’s important patient safeguards remain intact, while continuing to strengthen the future of vision care.

Although there are a number of common sense solutions to addressing some of today’s ongoing challenges—such as improving the enforcement of the existing FCLCA—the bipartisan, bicameral Contact Lens Consumer Health Protection Act (CLCHPA) of 2016 was a meaningful milestone as we work to meet the needs of patients both today and tomorrow.

Fulfilling a commitment to the future of our industry through innovation is what is driving advocacy efforts. In addition to company-specific initiatives, it has driven our active membership and efforts through the Coalition for Patient Vision Care Safety. It has driven vigorous support of regulations and legislative efforts that help ensure the eye health and safety of contact lens patients and protect the practitioner-patient relationship while also ensuring healthy choice and competition in the marketplace. And, over the last few months and throughout 2016, it has driven efforts on the ground in the states—to stand up to do what’s right for patients.

In the end, all of the work around supporting eye health and vision safety and knowing that there is a coalition and a profession that truly cares about patient outcomes makes it easy to be an advocate. It makes it easy to know that, despite any hurdle or hardship, it’s the right place to be. And if you know that’s your north star—your direction—you can’t help but feel compelled to be involved in the process.

BECOMING INVOLVED IN ADVOCACY

Late last year, Dr. Cockrell and I were discussing the importance of encouraging more eyecare practitioners to become advocates, and he reminded me that, “One thing we are taught in optometry school is that [we are part of a] legislated profession.” I asked him to explain what he thought that meant.

“The legislature gets to decide issues like our scope of practice, how we get paid and reimbursed, and how medical devices, like contact lenses, get sold,” he said. “I heard this all in school, but it wasn’t until I went into practice that it really clicked. I realized that I didn’t want to be the guy sitting on the sidelines complaining about what wasn’t working. I had to get involved.”

Still, for so many students with whom I talk and colleagues I meet, it’s sometimes difficult to find the time or to feel compelled to get involved in advocacy.

Dr. Cockrell agreed. “When I graduated from school, our scope of practice was very limited for what we were trained to do,” he stated. “There also wasn’t maybe as much of a disinclination to be involved in politics as there is today—or maybe it’s just that I didn’t realize there was anything wrong with being involved in it. Today, one of our challenges is that there are a significant number of people who don’t want to be involved in politics.

“To be fair, it took me a while to realize that politics isn’t a bad word, it’s actually how our society functions—it’s all through legislative action,” he continued. “Over time, I learned that if I wanted anything to change, it was my responsibility to be involved, to be one of the [practitioners] involved in making changes happen. I learned that it truly does just take one voice to get involved to make a change.”

For many of us, being that one voice doesn’t always mean meeting with a legislator. For example, it might mean building understanding and awareness around issues by signing up to receive advocacy updates, sharing the information, and having important conversations with your colleagues and your patients about what’s at stake. It might also mean supporting organizations that work to advance your positioning, such as your local state association or national optometric associations, and asking how you can get involved. For others, it might mean taking direct action by sending a letter or making a phone call to a legislator.

What is important is that all eyecare practitioners take an active interest in the legislative issues that impact their patients and their practices. That each one of us finds a way to contribute to the advocacy efforts that keep patients safe as we continually navigate a sea of change.

In the end, as Dr. Hanian pointed out, “more than anything, you’re just talking to people, who happen to be legislators, and having the same conversation we have with our patients every day about the importance of eye health and doing what’s best for their vision. And, when you think about it like that, it’s a really easy conversation to have.” CLS

For references, please visit www.clspectrum.com/references and click on document #256.