Andrew Stivers, Ph.D., Director in NERA’s Antitrust Practice outlines the technological restraints of the Fairness to Contact Lens Consumers Act (FCLCA).
(WASHINGTON) – In a new report, Dr. Andrew Stivers, Director in NERA Economic Consulting’s Antitrust Practice, outlines the issues faced by consumers due to the Fairness to Contact Lens Consumers Act (FCLCA) and provides a strategic solution to protect patients and maintain competition in the market.
The FCLCA, passed by Congress and signed into law in 2003, was introduced to increase competition in the contact lens industry through a mandate that patients receive their prescription after a comprehensive eye exam. However, the FCLCA was considered by Congress when fewer technology solutions were available to consumers. As a consequence, the law allows some third party sellers of contact lenses to use automated telephone calls (“robocalls”) that unnecessarily raise prescribers’ costs at the risk of customers receiving incorrect, off-prescription lenses.
Twenty years later, a clear technology solution is now ubiquitous: the smartphones that most Americans carry every day would allow customers to take a picture of their prescription and send it electronically to contact lens sellers, reducing the unnecessary costs created by the inefficient and obsolete prescription verification option enabled by the FCLCA.
Dr. Stivers notes in the report, “In a compromise that appears to be heavily dependent on the generally available technology of the early 2000s, the Act did not require that customers provide a facsimile of their prescription to retailers.”
Instead, the FCLCA imposes additional costs on consumers by requiring prescribers to incur costs when responding to requests for verification from non-prescriber third-party contact lens sellers. Prescribers are not allowed to charge the sellers for this service, burdening them under the current verification process.
Sellers further manipulate the system by strategically increasing the costs of responding to verification requests, decreasing the response rate, and increasing the likelihood of being able to fulfill a consumer’s order without verifying the prescription. The impacts on patient safety in this scenario cannot be understated.
Non-prescribing sellers can also raise costs through the use of robocalls. FCLCA assigns rights to non-prescribing sellers, allowing them to fulfill orders if the prescriber doesn’t verify a prescription within 8 business hours. The robocalls add unexpected and unsolicited costs to prescribers, whether through answering the calls or implementing a system to filter them and ensure patients receive their proper prescriptions.
In short, FCLCA allows non-prescribing sellers to leverage low-cost robocalls in the verification process to raise competitors’ costs. The outdated verification process of requiring consumers to readily provide facsimiles of their prescriptions creates inefficiencies and inaccuracies in their prescription verifications.
Dr. Stivers proposes a solution, stating, “The requirements of the verification process should be changed to ensure that sellers cannot strategically impose asymmetric costs on prescribers. Given currently available technologies, and the direction taken by the health care industry in information technology that create symmetric, secure systems for transmitting health information under HITECH and other laws, electronic health record systems could provide a framework for contact lens prescription verification.”
The Health Care Alliance for Patient Safety is calling on the FTC and FDA to take immediate action to protect patients and the eye health of all people in the United States. More regulations need to be put in place to ensure patients receive safe and effective products. Contact lenses are a medical device and should be treated as such.
Additionally, the Alliance is calling on Congress to ban robocalls in the prescription verification process and pass the Contact Lens Prescription Verification Modernization Act (H.R. 2748). Passing this bill is critical in increasing the safety of the more than 45 million Americans who rely on contact lenses – U.S. Food and Drug Administration Class II and Class III regulated medical devices – for safe and effective vision correction.
The Health Care Alliance for Patient Safety has made it a priority to close loopholes within the existing verification process and prevent the substitution of lenses to reduce the risk of preventable vision loss.
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The Health Care Alliance for Patient Safety (HCAPS) was founded in 2018 to advocate for patient safety and to protect and defend the doctor-patient relationship – the essential foundation of personalized health care decision making. For more information, please visit www.PatientSafetyToday.com.
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