A new bill aims to amend the Fairness to Contact Lens Consumers Act (FCLCA) by augmenting the prescription verification process.
Introduced by Rep. Ed Whitfield (R-Ky.), the Contact Lens Consumer Health Protection Act (H.R. 6117) is a response to eye-care practitioners concerns about patient safety and the prescription verification process. The bill would change the FCLCA in three important ways. Specifically, it would:
Require each contact lens seller to establish a toll-free telephone hotline and a dedicated e-mail address for the sole purpose of responding to prescribers questions and concerns regarding verification requests. By contacting the company this way, the eye-care practitioner would suspend the eight- hour verification period until the seller addresses the concern.
Allow eye doctors to choose a preferred means of verifying prescriptions, namely by telephone, facsimile or e-mail, or by any two of these three means of communication.
Significantly raise the penalty for violating the FCLCA from the current $11,000 maximum penalty to $100,000 per violation.
Also, the bill calls for the Federal Trade Commission, with input from the Food and Drug Administration, to provide a report to Congress about seller verification abuses and the harm caused to consumers.
Completing contact lens sales without properly verifying a patients medical history is an unacceptable business practice and clearly contrary to the best interest of consumers health, Rep. Whitfield says. This legislation will facilitate communication between doctors and third-party vendors, ensuring that patients receive products that are safe and compatible with their documented medical history.
This bills proposal follows in the wake of another bill, the Contact Lens Consumer Protection Act (H.R. 5762), introduced in July. This bill, supported by 1-800 Contacts, would also amend the FCLCA by eliminating the practice of limited distribution (that is, selling doctors only lenses). Specifically, H.R. 5762 would require contact lens manufacturers to distribute their lenses to any business that wishes to sell them, including Internet and mail-order companies.
On September 15, a subcommittee hearing in the U.S. House of Representatives aired these issues, although little was resolved. At that hearingbilled Contact Lens Sales: Is Market Regulation the Prescription?Maureen Ohlhausen, the director of the Federal Trade Commissions Office of Policy Planning, restated the FTCs position that there is no indication that limited distribution policies in the contact lens industry harm consumers.
Jonathan C. Coon, CEO of 1-800 Contacts, also testified. He characterized doctors only lenses as a loophole in the FCLCA that allows a doctor to comply with the FCLCA by releasing the prescription but avoid the intent of the law by prescribing a lens that is only available from a doctor or an affiliated retailer.
Mr. Coon also said that the American Optometric Association could not both endorse a patients right to purchase contacts from whomever the patient chooses and oppose a bill that would restrict the patients right to do so.
In response, optometrist Wiley Curtis, of Arlington, Texas, represented the AOAs position, tempered by his own experience. Over the course of this year, I have tracked 18 contact lens orders placed with 1-800 Contacts, he says. I am saddened to report that the first 17 orders were all filled by the company without any verification contact with my office, in apparent violation of the FCLCA.
After the hearing, 1-800 Contacts looked into this accusation. Our records from the last 12 months to this doctors office show 192 phone calls, three faxes and eight total hours on the phone with his staff, says Kevin McCallum, 1-800 Contacts senior vice president of marketing and operations. We received 117 orders from this doctors patients. All 117 orders received a successful verification request.
Meanwhile, the AOA is tracking 1-800 Contacts requests to optometric practices for complete contact lens prescriptionsa step beyond prescription verification. Unauthorized release of a patients complete prescription could constitute a violation of the Health Insurance Portability and Accountability Act (HIPAA), the AOA says.
Doctors who receive requests for complete prescriptions should ask the seller for proof (in the form of a HIPAA-compliant document signed by the patient) that the patient designated the company to make this request, the AOA says. The doctor should also contact the patient to verify that the companys Rx request is valid.
In response, 1-800 Contacts points out that this maneuver is not permitted by the FCLCA, which specifically forbids prescribers from requiring the patient sign a waiver as a condition of verifying or releasing the patients prescription.
At issue: Whether a seller can act as a legal agent of a patient (and obtain a complete Rx) regardless of when the patient ordered the lenses. In other words, 1-800 Contacts is not acting as a designated agent if the patient is not currently in the process of ordering lenses, the AOA suggests.
But 1-800 Contacts contends that it satisfies this requirement because it made these requests for complete prescriptions on the same day that the patients ordered lenses, according to Mr. McCallum.