Final changes to the Contact Lens Rule didn’t come about overnight—in fact they date back to 2015, when the Rule was opened for its first scheduled 10-year review. The Rule itself has its origins in 2004, when it was formally enacted after Congress passed a law to better regulate the contact lens marketplace.
Here’s how the Contact Lens Rule has evolved since 2004—including key proposals that became new, finalized requirements—and legislation in Congress now that would make key changes to the final Contact Lens Rule:
2004: Contact Lens Rule Implementation
- Prescription Verification: Sellers must verify a patient’s prescription with a provider if a copy of the prescription is not directly provided to them (including via fax, telephone, or email).
- Prescription Release: Prescribers must provide a patient with a copy of their prescription.
- Prescription Alteration: Sellers may not alter a prescription, except in cases when substituting for their own “private label” lenses—those made by the same manufacturer but sold under a different name.
- Prescription Expiration: Contact lens prescriptions expire on the date specified by state law, as specified by the doctor, or at least one year after prescription is issued.
2015: 10 Year Review of the Rule and Public Feedback
Challenges in the prescription verification process: many stakeholders commented that loopholes in the prescription verification process compromise patients’ access to their prescribed lenses.
- Robocalls: Sellers’ use of automated “robocalls” or recorded messages left for a provider’s office for purposes of prescription verification that may be garbled or incomplete.
- Prescription Alteration: Sellers dispense lenses to patients other than those prescribed to them, which could potentially impact a patient’s eye health and safety.
2016: Proposed Update to the Rule
- Prescription Release: Proposed to require that prescribers obtain copy of a patient’s signed acknowledgement of prescription release to ensure they understand their prescription is portable.
- Prescription Alteration: Proposed to remove the term “private label” from the Rule to ensure it is clear to sellers when permissible to substitute for their own private label lenses.
2018: FTC Public Workshop
- FTC holds public workshop examining Contact Lens Rule/marketplace and welcomes written comments. Many continued to express persistent issues with loopholes in the prescription verification process, such as robocalls and prescription alteration, which FTC did not address in 2016.
2019: Supplemental Proposed Update to the Rule
- Prescription Verification: Acknowledges some of the issues that robocalls present—but does not ban them as a permissible form of direct communication via telephone to verify patient prescriptions.
- Prescription Release: Modifies its previous proposal allowing for greater flexibility around how a prescriber may obtain confirmation of prescription release, including through digital means.
- Prescription Alteration: Expands the definition of prescription alteration to explicitly include instances where a seller provides a brand/manufacturer of lenses other than those prescribed; requires that sellers provide patients with a means to present them with their prescriptions.
2020: Final Contact Lens Rule Outcome
- Prescription Verification: Deemed robocalls permissible because they fall within definition of direct communication via telephone that is consistent with the FCLCA.
- Prescription Release: Finalized latest proposal to require signed confirmation of prescription release after contact lens fitting, and that a record of confirmation be kept on file for three years.
- Prescription Alteration: Finalized expanded definition of prescription alteration and maintained “private label” distinction; finalized requirement that sellers provide patients with a means to present them with their prescriptions, creating a stronger prescription paper trail.
Looking Ahead: Addressing Missed Opportunities in the Contact Lens Rule
- New Requirements in the Contact Lens Rule went into effect on October 16, 2020, but an act of Congress can still make changes to the Rule.
- New Legislation: Johnson & Johnson Vision supported the Contact Lens Rule Modernization Act, legislation that would eliminate robocalls as an option to verify contact lens prescriptions and remove the requirement for signed acknowledgment of prescription release (replacing it instead with office signage).
We’re committed at Johnson & Johnson Vision to continue working closely with the eye care community, policymakers, and regulators to advance policies that prioritize the patient-doctor relationship and put the health and safety of patients first.