The Contact Lens Rule which was effective in 2004, implemented the Fairness to Contact Lens Consumer Act of 2003 (15.U.S.C. 7601-7610). The Act seeks to enable consumers to purchase contact lenses from the seller of their choice. Among other things, the Act requires contact lens prescribers to provide contact lens prescriptions to their patients, and to provide or verify contact lens prescriptions to third parties designated by patients.
On June 23, 2020, the Federal Trade Commission announced a Final Rule to enhance and further ensure compliance with the Fairness to Contact Lens Consumers Actâs requirement that prescribers automatically provide their patients with a copy of their prescription upon completion of a contact lens fitting. The Final Rule requires prescribers to
request that their patients confirm that they have received their prescription, and allows flexibility in the way the prescription and confirmation are provided. Prescribers must maintain proof that they satisfied the confirmation of prescription release requirement for at least three years. Eye doctors were already required by law to provide every
patient with a copy of his or her contact lens prescription, allowing patients to comparison shop for lenses. This rule change will help to ensure that eye doctors fulfill their obligations, and will facilitate FTC enforcement of these important requirements.
To address concerns about third-party sellers verifying prescriptions by leaving incomplete or incomprehensible automated telephone messages with prescribers, sellers who use automated telephone messages for verification must record the calls and preserve the recordings for three years. This will likely require a minimal amount of capital and other non-labor costs to record the calls and store them electronically.
The Commission estimates that the amendments in the Final Rule will result in an additional 875,000 annual burden hours for all affected original contact lens prescribers, $19,900,000 in associated labor costs for prescribers, and $591,300 in capital/non-labor costs for third-party sellers. The estimated increase in burden is correlated with Rule
modifications creating a verifiable enforcement mechanism to ensure that pre-existing Fairness to Contact Lens Consumer Act and Contact Lens Rule requirements that prescriptions be provided by the prescribers to patients are complied with. To further explain, the existing Rule already requires that prescriptions be provided by the prescribers to patients but there is no enforcement mechanism. The Rule amendment adds the enforcement mechanism to what the Rule already required. With more patients in possession of their prescriptions (due to increased prescription release), and a greater ability to present them to sellers, FTC staff anticipates a potential reduction in time-consuming prescription verifications from sellers to prescribers.
Although FTC staff anticipates that these requirements will impose some additional burden on individual prescribersâ offices to satisfy the confirmations of prescription release requirements, FTC staff believes this burden will be relatively small in the context of the overall market for contact lenses and examinations. One survey estimated that the U.S. contact lens market totaled approximately $5 billion (not counting examination revenue) in 2017. See âVision Markets See Continued Growth in 2017, VisionWatch Says,â Vision Monday, March 20, 2018, http://www.visionmonday.com/business/research-and-stats/article/vision-markets-see-continued-growth-in-2017-visionwatch-says/. Accordingly, the incremental burden associated with the Rule amendments would not have a significant impact on the contact lens market.
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
Contact Lens Final Rule - Supplemental Supporting Statement - 6-25-2020-FINAL.pdf
Contact Lens Rule: Third Party Sellers (not original prescribers) with recordkeeping obligations when verification not required