Contact lens legislation provides protection for patients, competition in the market

The Fairness to Contact Lens Consumers Act has increased patient convenience, but it has shortcomings, practitioners say.

In the 2 years it has been in force, the Federal Trade Commission’s Fairness to Contact Lens Consumers Act has received both praise and criticism from physicians. The law, which mandates that contact lens patients be given a copy of their prescription, has provided more options to patients but has some shortcomings in the area of safety, physicians say.

The legislation, enacted in December 2003, allows all contact lens sellers to distribute their products through a process known as passive verification, said Thomas L. Steinemann, MD, a spokesman for the American Academy of Ophthalmology.

In passive verification, when a contact lens provider receives a prescription to fill, that entity must contact the prescribing eye care professional to verify the legitimacy of the prescription within 8 business hours.

This process was put in place to ensure not only that the prescription is current, but also that the physician indeed prescribed the lens the patient is requesting.

“At the time of the exam, the prescription must be released to the patient. The seller is only obligated to fill prescriptions that are current because they expire in 1 year,” Dr. Steinemann said.

The law in general works well, physicians interviewed for this article said, but there are times when it inconveniences physicians and when its safety provisions break down.

Staying competitive

The law “certainly has allowed the consumer-patient to shop around and find competitive pricing for contact lenses,” Dr. Steinemann said.

This element of the law generates competition in the contact lens market, he noted.

“I think physicians have to stay price competitive, but at the same time the most effective practices are those practices that build value into the exam,” Dr. Steinemann said. “Provide a service that is valued by the patient, and keep your prices competitive.”

Peter C. Donshik, MD, Ocular Surgery News Optics, Refraction and Contact Lens Section Member, agreed with Dr. Steinemann’s assessment. He said his practice keeps a full inventory of many lens styles, and most of his patients get their contact lenses from his office. Only a small percentage fill their prescriptions elsewhere.

“We maintain an inventory, especially for the disposables and frequent replacement contact lenses. For contact lenses that are not inventoried, we can order them and dispense them to the patient within 2 to 3 days,” he said.

Choice and safety

Michael D. DePaolis, OD, FAAO, said he has been a proponent of the legislation since it was enacted.

Michael D. DePaolis

“From my perspective, the Fairness to Contact Lens Consumers Act was a very important piece of legislation. I know a lot of my colleagues would disagree with that statement because they simply looked at it as a mandate that patients be given their contact lens prescription and therefore have the right to exercise their option to purchase lenses elsewhere. But the legislation goes far beyond that,” he said. “The legislation is really about patient-consumer choice and safety.”

Dr. DePaolis, Chief Optometric Editor for Primary Care Optometry News, said the legislation has since validated for patients that contact lenses are medical devices that must be treated as such.

“The reality is, it is a prescription device and the patient cannot just refill it at will,” he said. “Could you imagine leaving your doctor’s office with a medicine prescription and being able to refill it for 5 or 6 years? That was happening in contact lenses through alternate vendors.”

The legislation holds all contact lens purveyors to the same standard of care, he said.

“Simply put, you cannot dispense replacement contact lenses without a valid prescription,” he said.

“The legislation also provides the consumer with the right to purchase contact lenses wherever they may, but it very importantly protects the consumer,” he said.

Dr. DePaolis said the legislation has caused practitioners to be more open about their lens fees and replacement costs.

“Patients will very often find that prices are similar, if not identical,” Dr. DePaolis said. “More important, as doctors educate their patients, the patient becomes a more well-informed consumer.”

A breakdown in the process

Although the legislation was intended in the best interest of the consumer-patient, it has shortcomings both in consumer safety and in inconveniencing eye care providers, according to several physicians.

“All eye care professionals have faced a scenario where we have gotten notification of lenses being sold, and we may have gotten a fax or a voice mail that John Jones is a stated patient and ‘Dr. Smith, you are the eye care professional, and we are waiting for you to verify this,’ ” Dr. Steinemann said. “Sometimes you are in the operating room or away from the office, and you have to delegate this to staff. There is a little bit of a time element here, particularly in a small office. It’s not uncommon that you may not be able to get back to verify that prescription within an 8-hour window. This has placed an extra burden on the eye care professional, to verify that prescription.”

If the physician finds that a prescription that has been sent for verification was not written by him, problems can ensue, Dr. Steinemann said.

“Then, when we try to call or fax back, we cannot get through,” he said. “So this passive verification process, under those circumstances, breaks down.”

If the physician is unable to verify the prescription within that 8-hour window, he or she should assume the lenses have been dispensed, Dr. Steinemann said.

“I think that is one of the problems with passive verification,” he said.

Policing the legislation

The legislation has been helpful in some ways, Dr. Donshik said, but the government does not have the ability to regulate its use thoroughly.

“I would not like to see any entity be able to replace a contact lens. With this law, one could possibly replace contact lenses at a gas station. I think there is a problem in removing the replacement of contact lenses from professional individuals,” Dr. Donshik said. “We don’t fill prescriptions without a pharmacist, yet we’re allowing anybody to take lenses off the shelf to fill a prescription.”

It’s imperative that professionals be vocal if they encounter problems that defy this legislation, according to Dr. DePaolis.

“All infractions are not being reported, but for sure the various professional organizations have educated their constituents on how to report infractions,” he said. “It becomes incumbent upon us, as providers, to police the industry.”

For Your Information:

• Michael D. DePaolis, OD, FAAO, can be reached at 169 Rue de Ville, Rochester, NY 14618; 585-271-2990; fax: 585-586-1840; e-mail: mgadep@aol.com.
• Peter C. Donshik, MD, can be reached at 47 Jolley Drive, Bloomfield, CT 06002; 860-286-5448; fax: 860-286-5449; e-mail: pdonshik@snet.net.
• Thomas L. Steinemann, MD, can be reached at MetroHealth Medical Center/Ophthalmology, 2500 MetroHealth, 3rd Floor, Cleveland, OH 44109; 216-778-4253; fax: 216-778-7863; e-mail: tsteinemann@metrohealth.org.

• Daniele Cruz is an OSN Staff Writer who covers all aspects of ophthalmology.