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2020 FTC Rule Update

2020 FTC Contact Lens Rule Update

Woman with contact lens

 

On June 23, the Federal Trade Commission (FTC) announced final amendments to the Contact Lens Rule (“the Rule”) that impacts eye care professionals and other stakeholders. These new requirements have significant administrative implications for professionals, particularly as this announcement comes in the midst of the coronavirus (COVID-19) pandemic.  

While the FTC finalized important actions to promote patient safety and accurate prescription dispensing, the Final Rule missed a critical opportunity to modernize the prescription verification process by eliminating robocalls, and instead added substantially more complexity and paperwork to the prescription release process.

We empathize with all eye care professionals who are impacted by these requirements, and we remain strongly committed to supporting you. Johnson & Johnson Vision will continue to ensure your voice is heard and through our advocacy work we remain actively engaged with the FTC, the Food & Drug Administration (FDA), and Congress to preserve the importance of the patient-doctor relationship at the center of care.


Automatic prescription release:

New requirements for patient acknowledgement of prescription receipt: FTC finalized its latest proposal on automatic prescription release to require that prescribers maintain a signed confirmation of prescription release from the patient once the lens fitting is complete, and that a record of that signed acknowledgement is kept on file for three years. The final rule includes options for eye doctors to fulfill prescription release requirements through other means, and also provides exemptions for doctors who do not sell contact lenses. While we believe all patients should have access to a contact lens prescription, we recognize that these new requirements represent a significant administrative change for eye doctors and we empathize with all eye care professionals who are impacted by these requirements. We remain strongly committed to supporting you.

Prescription verification:

New enhancements and restrictions related to the use of robocalls (but not elimination): We are disappointed that FTC did not finalize actions to modernize the prescription verification process by eliminating robocalls as a permissible method of prescription verification. While FTC finalized additional requirements for automated verification calls, we remain concerned that robocalls will likely continue to present challenges to providers and compromise patients’ access to their prescribed lenses. We believe there is more work to be done through Congress to enact a legislative solution to eliminate robocalls. As a leading member of the Health Care Alliance for Patient Safety, Johnson & Johnson Vision is proud to support the Contact Lens Prescription Verification Modernization Act, H.R. 3975, bipartisan legislation that would eliminate the use of robocalls to verify contact lens prescriptions, and thereby further enhance patient eye health and safety. To further this cause, Johnson & Johnson Vision, headquartered in Jacksonville, Florida, supported a bipartisan effort from the Florida Congressional Delegation who called upon the FTC to eliminate robocalls.

Prescription alteration:

New definitions of illegal and legal alteration of a contact lens prescription: We support the FTC’s decision to expand the definition of prescription alteration to include brand and manufacturer and maintain the important distinction of “private label” to indicate the only instance where brand substitution is permissible (i.e., when the lenses are made by the same manufacturer, but sold under a different name). These updates will help ensure that patients receive the correct lenses as prescribed by their doctor.

Prescription presentation:

New methods for consumers to provide their contact lens prescription to sellers: We strongly support FTC’s decision to require that sellers provide a mechanism for patients to directly upload and share their prescriptions with the seller. This update will promote a clear prescription “paper trail”, reduce sellers’ reliance on the passive verification process, and contribute to more accurate prescription fulfillment.

These changes will go into effect 60 days upon posting in the Federal Register.

Johnson & Johnson Vision remains committed to advocating along with eye care professionals and many other stakeholders in support of patient health and safety and the importance of the patient-doctor relationship. Our advocacy efforts will remain unwavering.