The seemingly simple process of ordering contact lenses has become a tangled debate between retailers, optometric groups, and lawmakers. At the core of the debate is the contact lens prescription, a ticket to 20/20 vision for an estimated 40 million American consumers. Although the FTC enforces the requirement eye care professionals provide patients a copy of their contact lens prescriptions, as required by the Contact Lens Rule (CLR), it seems many may not be complying. 1-800-Contacts, the largest U.S. contact lens retailer, announced it filed 27,725 potential violations earlier this month with the agency related to optometrists not releasing patient prescriptions.
Cindy Williams, general counsel at 1-800-Contacts, told Healthcare Dive those violations were compiled over from December 2015 to March 2016 showing “how extensive and widespread this problem is."
How we got to the filing
The prescription verification process is somewhat cumbersome under CLR and requires sellers to confirm the prescription is correct via phone, fax or email. Prescribers have eight hours to respond to that request. If they don’t respond during that time period, the prescription is verified automatically and the seller fills the order. “This is called the passive verification system,” explained Williams. “That was a carefully crafted system that Congress created to balance the interests of the consumers and to create competition in the market given that the prescribers and retailers compete with each other for the sale.”
In the case of 1-800-Contacts, the company employs an opt-out option if a customer doesn't want the company to act as an agent to obtain their prescription. However, this practice raised concerns among eye care professionals and the FTC requested the company change to an opt-in request. Yet, Williams said despite the change, “the eye care doctors still did not release the prescriptions in accordance with the law…and that’s why we looked over the four-month period to obtain the violations and file them with the FTC.”
FTC told Healthcare Dive it is taking the company’s filing seriously but was unable to provide further information since ongoing investigations are private. It’s interesting to note the FTC issued 55 warning letters about potential violations to the CLR only about a week before the 1-800-Contacts’ filing. Most of the letters were sent to prescribers (45), with another 10 sent to contact lens sellers – a mix of online and brick-and-mortar retailers.
A press release issued by the agency stated, “Under the Rule [CLR] prescribers fitting patients for contact lenses are required to give them their prescription at the end of the fitting. Prescribers are also prohibited from charging additional fees for releasing the prescription and from obligating a patient either to buy contact lenses from them or to sign a waiver, before releasing a prescription.” Violations of the rule can result in penalties up to $16,000 each. Yet, a reader survey compiled by the publication, Contact Lens Spectrum in 2008 found despite the CLR, only half of respondents said they released contact lens prescriptions to every patient.
Legislation to ensure consumer’s rights?
Many sellers use automated phone systems to send verification requests, which the American Optometric Association (AOA), with nearly 40,000 members, refers to as “robocalls,” and adamantly opposes. In fact, this was one of the concerns the group brought to the FTC’s attention last year when the agency called for public comments for its 10-year review of the CLR. The comment period accrued more than 600 responses, which the FTC is currently reviewing. Once completed, FTC will provide a notice of any proposed rule changes along with another public comment period.
The AOA’s comments to the agency reflected members’ concerns regarding the passive verification process being abused. The group is backing new legislation recently introduced by Senator Bill Cassidy (R-LA), the Contact Lens Consumer Health Protection Act of 2016 (S.2777). The new bill addresses the issue of passive verification by establishing a live patient safety hotline for doctors to provide sellers with patient health information, banning the use of automated verification calls as the way to verify prescriptions and instead use live phone calls or emails, and ensuring lenses are dispensed exactly as the prescription is written by the doctor. It also suggests raising the penalty for seller violations to $40,000 per infraction.
“This bill puts in place a clear mechanism by which healthcare providers can communicate to the retail seller any concerns regarding filling a contact lens prescription during the eight-business-hour window called for under the current law,” Dr. Steven Loomis, AOA president, told Healthcare Dive in an email. “Optometrists, like all doctors, want and expect their prescriptions to be filled, and they want those prescriptions filled accurately which is the objective of this bill."
However, Williams of 1-800-Contacts told Healthcare Dive the new bill “was intentionally designed to hurt the consumer because it will allow an optometrist to block a consumer from buying contacts from their retailer of choice. The result of the bill will be to make contact lenses more expensive and harder to obtain from anyone other than the optometrist who prescribed them.”
Seeing is big money
Contact lenses are big business in the U.S. and the market is expected to reach $13.5 billion by 2020, according to report by Hexa Research. 1-800-Contacts delivers more than 200,000 contact lenses daily directly to consumers with 98% shipped within one day of receipt and verification of prescriptions.
However, since Medicare and Medicaid do not cover contact lenses (Medicare Part B helps cover contact lenses after cataract surgery) nor do many private insurers, it’s safe to assume there are many consumers paying out of pocket. “Now they want to completely overturn the [Fairness to Contact Lens Consumers Act] which was overwhelmingly passed by Congress in 2003 and designed to foster competition and consumer choice. We believe that the party that’s going to be harmed by Senator Cassidy’s proposed legislation is the consumer,” Williams said.
A quick online research inquiry found that the average monthly supply of contact lenses (depending on the type and brand) varies from around $22 up to $60 per month (not including cleaning solutions or other supplies) – or up to $720 a year.
The AOA is looking to the new bill to prevent questionable retailer business practices. “Recent surveys and doctor reports concur that the filling of expired prescriptions, the substitution of other contact lens products, often unknowingly to the patient, and the solicitation of patients to order large supplies of contact lenses just before the expiration date of the contact lens prescription demonstrate that some contact lens retailers have decided to put profits ahead of patient safety,” Dr. Loomis concluded. “The Cassidy Bill provides common sense solutions to this high-stakes situation.”
Whether the FTC proposes changes to the CLR or Sen. Cassidy’s new bill is passed, contact lenses are considered medical devices and can potentially cause injury with the incorrect prescription or brand. Consumer safety needs to be enforced yet maintaining market competition is especially important for contact lenses since many consumers pay out-of-pocket for them. It’s a balancing act that will hopefully conclude with all stakeholders seeing eye-to-eye.