Contact Lens Rule

Published date17 August 2020
Citation85 FR 50668
Record Number2020-14206
SectionRules and Regulations
CourtFederal Trade Commission
Federal Register, Volume 85 Issue 159 (Monday, August 17, 2020)
[Federal Register Volume 85, Number 159 (Monday, August 17, 2020)]
                [Rules and Regulations]
                [Pages 50668-50718]
                From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
                [FR Doc No: 2020-14206]
                [[Page 50667]]
                Vol. 85
                Monday,
                No. 159
                August 17, 2020
                Part III
                Federal Trade Commission
                -----------------------------------------------------------------------
                16 CFR Part 315
                Contact Lens Rule; Final Rule
                Federal Register / Vol. 85, No. 159 / Monday, August 17, 2020 / Rules
                and Regulations
                [[Page 50668]]
                -----------------------------------------------------------------------
                FEDERAL TRADE COMMISSION
                16 CFR Part 315
                RIN 3084-AB36
                Contact Lens Rule
                AGENCY: Federal Trade Commission (``FTC'' or ``Commission'').
                ACTION: Final rule.
                -----------------------------------------------------------------------
                SUMMARY: The FTC is publishing a final rule to implement amendments to
                the Contact Lens Rule. These amendments require that prescribing eye
                care practitioners obtain a confirmation of prescription release from
                patients after releasing a contact lens prescription and maintain each
                such acknowledgment for a period of not less than three years. The
                Commission is permitting prescribers to comply with automatic
                prescription release via electronic delivery in certain circumstances.
                Further, these amendments specify a time period for prescribers to
                respond to requests for prescriptions; clarify and institute additional
                requirements for automated telephone verification messages; more
                precisely delineate what constitutes unlawful alteration of a
                prescription; and require that sellers provide a method for, and notice
                of the method for, patient prescription presentation.
                DATES: This rule is effective October 16, 2020.
                ADDRESSES: Relevant portions of the record of this proceeding,
                including this document, are available at https://www.ftc.gov.
                FOR FURTHER INFORMATION CONTACT: Alysa Bernstein (202-326-3289),
                [email protected], Paul Spelman (202-326-2487), [email protected], or
                Andrew Wone (202-326-2934), [email protected], Bureau of Consumer
                Protection, Federal Trade Commission, 600 Pennsylvania Avenue NW,
                Washington, DC 20580.
                SUPPLEMENTARY INFORMATION:
                Table of Contents
                I. Background
                 A. Overview of the Contact Lens Rule
                 B. History of the Rule
                 C. Initial Request for Comments in 2015
                 D. Notice of Proposed Rulemaking in 2016
                 E. Supplemental Notice of Proposed Rulemaking
                II. Final Rule Pertaining to Confirmation of Prescription Release
                 A. Proposed Modifications in the SNPRM
                 B. Basis for SNPRM Confirmation of Prescription Release Proposal
                 C. Comments on the Confirmation of Prescription Release Proposal
                and the Basis for Such Proposal
                 1. Comments About the Need for the Confirmation of Prescription
                Release and Whether Prescribers Are Complying With the Rule's
                Automatic Prescription Release Requirement
                 a. Survey Evidence as Proof of Non-Compliance
                 b. Lack of Consumer Complaints as Evidence of Compliance
                 c. Number of Verifications as Evidence of Non-Compliance With
                the Automatic Prescription Release Requirement
                 2. Comments About the Need To Improve the Commission's Ability
                To Monitor Compliance and Enforce the Rule
                 3. Comments About Whether the Structure of the Contact Lens
                Market Creates a Need for Verifiable Enforcement of Automatic
                Prescription Release
                 4. Comments About the Text of the Proposed Confirmation of
                Prescription and the Option To Include the Confirmation as Part of a
                Patient's Prescription or Sales Receipt
                 5. Comments About Option (D) and Using Electronic Delivery for
                Confirmation of Prescription Release
                 a. Use of Patient Portals and Patient Consent
                 b. Requirement To Maintain Records of Patient Consent
                 6. Comments About Alternatives to the Confirmation of
                Prescription Release
                 a. Signage
                 b. Educational Programs as an Alternative to Confirmation of
                Prescription Release
                 7. Comments About the Burden and Benefits of the Confirmation of
                Prescription Release Proposal
                 8. Comments About the Exemption for Prescribers Who Do Not Have
                a Direct or Indirect Financial Interest in the Sale of Contact
                Lenses
                 D. Additional Discussion and Commission Determination Regarding
                the Confirmation of Prescription Release Proposal
                III. Additional Requirements for Sellers Using Verification Calls
                Containing Automated Messages
                 A. The Congressional Record Does Not Support Prohibiting
                Automated Telephone Messages
                 B. Comments About, and Adoption of, Requirements Proposed in the
                SNPRM To Improve Quality of Automated Telephone Messages
                 C. The Commission's Proposal Requiring Sellers To Record
                Automated Telephone Messages
                 D. The Final Rule Does Not Adopt Commenters' Additional
                Recommendations Regarding Automated Telephone Messages
                IV. Prescribers' Selection of Communication Mechanism
                V. Miscellaneous Passive Verification Issues
                 A. Active Verification Is Not Required
                 B. Concerns About Patient Manipulation
                 C. Eight-Business-Hour Time Frame Is Appropriate
                VI. Seller Alteration of Contact Lens Prescriptions and Private
                Label Concerns
                 A. The Final Rule Includes a Requirement for Sellers To Accept
                Prescription Presentation
                 B. Alteration Includes a Seller Providing a Prescriber With a
                Verification Request for a Non-Prescribed Manufacturer or Brand, but
                Includes an Exception for Verifying a Manufacturer or Brand That a
                Consumer Indicates Is on Her Prescription
                 1. The Final Rule Modifications Regarding Alteration Are
                Beneficial and Address Abuses of the Verification System
                 2. Comments Related to the Exception to Alteration When a Seller
                Provides the Manufacturer or Brand of Lenses That a Consumer
                Provides in Response to a Seller's Request for That Information
                 3. Comments Regarding and Commission Guidance on Acceptable
                Methods for Obtaining the Brand or Manufacturer Listed on Consumers'
                Prescriptions
                 4. The Commission Is Not Imposing a Recordkeeping Requirement
                for Sellers Related to the Exception
                 C. Private Label Issues
                 1. The Commission Adopts a Technical Amendment and Clarifies
                That the Only Permissible Substitution Involves Private Label Lenses
                 2. The Commission Is Not Imposing Additional Requirements on
                Prescriptions for Private Label Lenses
                VII. ``Directly or by Facsimile'' Language Includes Use of Online
                Patient Portals to Present Prescriptions
                VIII. Requests for an Additional Copy of a Prescription
                 A. Benefits of an Additional Copy and the Time Period To Respond
                to a Request
                 B. Requirement To Maintain Records
                IX. Excessive Quantity
                X. Expiration of Contact Lens Prescriptions
                 A. Length of Contact Lens Prescriptions
                 B. Sales Using Expired Contact Lens Prescriptions
                XI. Paperwork Reduction Act
                 A. Confirmation of Prescription Release and Affirmative Consent
                to Digital Delivery of a Prescription
                 1. SNPRM Burden Estimate for the Confirmation of Prescription
                Release
                 2. Comments Regarding the SNPRM Estimate for the Confirmation of
                Prescription Release Requirement
                 3. Estimated Additional Burden Hours for the Confirmation of
                Prescription Release Requirement
                 4. Estimated Total Labor Cost Burden for the Confirmation of
                Prescription Release Modification
                 5. Capital and Other Non-Labor Costs for the Confirmation of
                Prescription Release Requirement
                 B. Recording of Automated Telephone Messages
                 C. Total Burden for the Modifications to the Rule
                XII. Regulatory Flexibility Act
                 A. Need for and Objectives of the Rule Amendments
                 1. Amendments Affecting Prescribers
                 2. Amendments Affecting Sellers
                 B. Significant Issues Raised by Public Comments in Response to
                the IRFA, Including Any Comments Filed by the Chief Counsel for
                Advocacy of the Small Business Administration, and the Agency's
                Response, Including Any Changes Made in the Final Rule Amendments
                 1. Amendments Affecting Prescribers
                [[Page 50669]]
                 2. Amendments Affecting Sellers
                 C. Description and Estimate of the Number of Small Entities to
                Which the Amendments Will Apply or Explanation Why No Estimate Is
                Available
                 D. Description of the Projected Reporting, Recordkeeping and
                Other Compliance Requirements of the Amendments, Including an
                Estimate of the Classes of Small Entities That Will Be Subject to
                the Requirement and the Type of Professional Skills Necessary for
                Preparation of the Report or Record
                 1. Amendments Affecting Prescribers
                 2. Amendments Affecting Sellers
                 E. Steps Taken To Minimize the Significant Impact, if Any, of
                the Amendments, Including Why Any Significant Alternatives Were Not
                Adopted
                 1. Steps and Alternatives for Amendments Affecting Prescribers
                 2. Steps and Alternatives for Amendments Affecting Sellers
                XIII. Congressional Review Act
                I. Background
                A. Overview of the Contact Lens Rule
                 In 2003, Congress enacted the Fairness to Contact Lens Consumers
                Act (``FCLCA'' or ``Act''),\1\ and pursuant to the Act, the Commission
                promulgated the Contact Lens Rule on July 2, 2004.\2\ The Rule went
                into effect on August 2, 2004.
                ---------------------------------------------------------------------------
                 \1\ 15 U.S.C. 7601-7610 (Pub. L. 108-164).
                 \2\ Contact Lens Rule, 16 CFR part 315 (2015).
                ---------------------------------------------------------------------------
                 The Contact Lens Rule (``Rule'') promotes competition in retail
                sales of contact lenses by facilitating consumers' ability to
                comparison shop for contact lenses. When an eye care practitioner
                (``prescriber'') \3\ completes a contact lens fitting, the Rule
                requires that the prescriber automatically provide the patient with a
                portable copy of the patient's prescription, whether or not the patient
                requests it.\4\ The Rule also requires that the prescriber verify or
                provide such prescriptions to authorized third parties. At the same
                time, the Rule requires that sellers only sell contact lenses in
                accordance with valid prescriptions written by licensed prescribers
                that were either (a) presented to the seller by the patient or a
                designated agent of the patient or (b) verified by direct communication
                with the prescriber.\5\
                ---------------------------------------------------------------------------
                 \3\ Under the Rule, prescriber is defined as an ophthalmologist,
                optometrist, or other person permitted under State law to issue
                prescriptions for contact lenses in compliance with any applicable
                requirements established by the Food and Drug Administration. `Other
                person,' in this context, includes dispensing opticians who are
                permitted under State law to issue prescriptions and who are
                authorized or permitted under State law to perform contact lens
                fitting services. 16 CFR 315.2.
                 \4\ The Commission also notes that apart from requiring that the
                contact lens fitting be complete, the FCLCA and Rule do not include
                any other requirements or exceptions that would permit a prescriber
                to withhold a patient's contact lens prescription following a
                fitting. 16 CFR 315.3(a)(1). Therefore, prescribers must
                automatically provide patients with copies of their prescriptions
                following their fitting, regardless of whether patients indicate an
                intention to purchase contact lenses--no matter the quantity (and
                even an annual supply)--from their prescribers.
                 \5\ 16 CFR 315.5(a).
                ---------------------------------------------------------------------------
                 The Rule further sets out the information that must be included in
                a seller's verification request, and directs that a prescription is
                only verified under the Rule if: (1) The prescriber confirms the
                prescription is accurate; (2) the prescriber informs the seller that
                the prescription is inaccurate and provides an accurate prescription in
                its stead; or (3) the prescriber fails to communicate with the seller
                within eight business hours after receiving a compliant verification
                request.\6\ The Rule states that if the prescriber informs the seller
                within eight business hours of receiving the verification request that
                the prescription is inaccurate, expired, or invalid, the seller shall
                not fill the prescription. The Rule requires that the prescriber
                specify the basis for the inaccuracy or invalidity of the prescription,
                and if the prescription is inaccurate, the prescriber must correct
                it.\7\ Sellers may not alter a prescription, but for private label
                contact lenses, may substitute identical contact lenses that the same
                company manufactures and sells under a different name.\8\
                ---------------------------------------------------------------------------
                 \6\ 16 CFR 315.5(b)-(c).
                 \7\ 16 CFR 315.5(d).
                 \8\ 16 CFR 315.5(e).
                ---------------------------------------------------------------------------
                 The Contact Lens Rule sets a minimum expiration date of one year
                after the issue date of a prescription with an exception based on a
                patient's ocular health.\9\ The Rule also incorporates the Act's
                preemption of state and local laws and regulations that establish a
                prescription expiration date of less than one year or that restrict
                prescription release or require active verification.\10\
                ---------------------------------------------------------------------------
                 \9\ 16 CFR 315.6.
                 \10\ 16 CFR 315.11(a). The Rule also preempts any other state or
                local laws or regulations that are inconsistent with the Act or the
                relevant section of the Rule, to the extent of the inconsistency. 16
                CFR 315.11(b).
                ---------------------------------------------------------------------------
                B. History of the Rule
                 The FTC has more than three decades of regulatory and research
                experience regarding the optical goods industry; this history continues
                to inform the basis and purpose of the Contact Lens Rule and this rule
                review. In addition to the Rule, the Commission enforces the Ophthalmic
                Practice Rules (known as the ``Eyeglass Rule''), initially promulgated
                in 1978.\11\ Prior to the Eyeglass Rule, surveys of optometrists found
                that a majority of prescribers imposed some restriction on the
                availability of the patient's prescription, usually by either refusing
                to release prescriptions or charging an additional fee to do so.\12\
                Prescribers also used waivers and liability disclaimers to discourage
                comparison shopping, mislead consumers, and frighten them into
                purchasing ophthalmic goods from the prescriber.\13\ The Commission
                determined that these actions reduced consumers' ability to obtain the
                lowest prices and hindered competition in the optical marketplace.\14\
                To address these problems, the Eyeglass Rule required prescribers--
                generally, optometrists and ophthalmologists--to provide each of their
                patients, immediately after completion of an eye examination, a free
                copy of the patient's eyeglass prescription.\15\
                ---------------------------------------------------------------------------
                 \11\ Final Trade Regulation Rule, Advertising of Ophthalmic
                Goods and Services, 43 FR 23992 (June 2, 1978) [hereinafter Eyeglass
                I]. The Rule was revised in 1992, with the revisions codified at 16
                CFR part 456. Ophthalmic Practice Rules, 57 FR 18822 (May 1, 1992).
                 \12\ 43 FR at 23998. See also FTC, ``Staff Report on Advertising
                of Ophthalmic Goods and Services and Proposed Trade Regulation
                Rule'' 240-48 (1977) [hereinafter 1977 Staff Report] (detailing
                myriad accounts of prescribers refusing to release eyeglass
                prescriptions to their patients), https://www.ftc.gov/system/files/documents/reports/staff-report-advertising-ophthalmic-goods-services-proposed-trade-regulation-rule-16-cfr-part-456/r611003-staff_report_on_advertising_of_ophthalmic_goods_and_services_and_proposed_trade_regulation.pdf.
                 \13\ 43 FR at 23998; Am. Optometric Ass'n v. FTC, 626 F.2d 896,
                916 (D.C. Cir. 1980) (noting considerable ``evidence of abuse'' by
                prescribers); see also 1977 Staff Report, supra note 12, at 277.
                 \14\ FTC, ``The Strength of Competition in the Sale of Rx
                Contact Lenses: An FTC Study'' 45-46 (2005), https://www.ftc.gov/sites/default/files/documents/reports/strength-competition-sale-rx-contact-lenses-ftc-study/050214contactlensrpt.pdf [hereinafter 2005
                Contact Lens Report].
                 \15\ 16 CFR 456.2 (separation of examination and dispensing).
                The FTC also has studied the effects of state-imposed restrictions
                in the optical goods industry. See FTC, ``The Effects of
                Restrictions on Advertising and Commercial Practice in the
                Professions: The Case of Optometry'' (1980), https://www.ftc.gov/sites/default/files/documents/reports/effects-restrictions-advertising-and-commercial-practice-professions-case-optometry/198009optometry.pdf.
                ---------------------------------------------------------------------------
                 The Eyeglass Rule, however, did not encompass contact lens
                prescriptions. While a majority of states enacted their own statutes
                requiring some form of contact lens prescription release,\16\ many
                prescribers continued to withhold prescriptions for contact lenses.\17\
                This,
                [[Page 50670]]
                and other prescriber practices (such as requiring liability waivers,
                refusing to verify prescriptions when consumers tried to buy lenses
                from third-party sellers, and encouraging manufacturers not to
                distribute contact lenses to third-party sellers), made it challenging
                for consumers to obtain lenses from anyone other than their
                prescribers.\18\ According to Congress, these obstacles were rooted in
                an ``inherent conflict of interest'' in that ``[u]nlike medical doctors
                who are prohibited from selling the drugs they prescribe, eye doctors
                and optometrists . . . are able to fill the contact lens prescriptions
                they write.'' \19\ Third-party sellers are thus forced to compete for
                the sale of lenses with the individual who is writing the
                prescription.\20\ To address this inherent conflict of interest and
                achieve freedom of choice and the benefits of competition for contact
                lens consumers, Congress passed the Fairness to Contact Lens Consumers
                Act in 2003,\21\ and, in 2004, the Commission issued the Contact Lens
                Rule,\22\ implementing the Act.
                ---------------------------------------------------------------------------
                 \16\ By 2003, more than two-thirds of states had laws requiring
                some form of contact lens prescription release. H.R. Rep. No. 108-
                318, 108th Cong., 1st Sess. 4 (2003), at 8 (2003).
                 \17\ See id. at 4 (noting that ``[t]he practice of optometrists
                withholding the prescription [for contact lenses] has limited the
                consumer's ability to shop for the best price and has impacted
                competition''); Fairness to Contact Lens Consumers Act: Hearing
                Before the Subcomm. on Commerce, Trade, and Consumer Protection of
                the H. Comm. on Energy and Commerce, 108th Cong. 1 (2003)
                [hereinafter FCLCA Subcomm. Hearing] (statement of Ami Gadhia,
                Consumers Union) (noting that multiple surveys of consumers in Texas
                had found considerable numbers were unable to obtain their contact
                lens prescription from their prescribers).
                 \18\ H.R. Rep. No. 108-318, at 4; FCLCA Subcomm. Hearing, supra
                note 17 (statements of Howard Beales, Jonathan Coon, Ami Gadhia,
                Robert Hubbard, Maria Martinez, Rep. W. J. Tauzin; Peggy Venable).
                See also In re Disposable Contact Lens Antitrust Litig., No. 94-MDL
                1030-J-20A (M.D. Fla.), in which the Attorneys General of 31 states
                alleged that eye-care professionals engaged in an organized effort
                to prevent or hinder consumers from obtaining their contact lens
                prescriptions. The complaints alleged two conspiracies: (1) That the
                practitioners and their trade associations conspired to prevent the
                release of contact lens prescriptions to consumers, and (2) that
                manufacturers, practitioners, and trade associations, including the
                American Optometric Association, conspired to eliminate sales of
                contact lenses by pharmacies, mail order, and other alternative
                sellers. Id. According to the Attorneys General, the conspiracy
                severely restricted the supply of contact lenses available to
                alternative sellers, which hampered the growth of such sellers,
                decreased the supply of lenses to consumers, and increased the price
                of lenses. Id. The parties reached settlements, the last of which
                the court approved in November 2001. As part of the settlements,
                manufacturers agreed to sell contact lenses to alternative
                distribution channels.
                 \19\ H.R. Rep. No. 108-318, at 5. See also Letter from Senators
                Richard Blumenthal and Orrin G. Hatch of the United States Senate
                Regarding the Contact Lens Rule Rulemaking Proceeding and the
                Proposed Rule Set Forth in the Notice of Proposed Rulemaking (Aug.
                11, 2017) (recognizing the ``inherent conflict of interest'' and
                noting that the FCLCA was made necessary by ``the unique nature of
                the contact lens marketplace''), https://www.ftc.gov/system/files/filings/initiatives/677/public_comment_from_senators_blumenthal_and_hatch_re_contact_lens_rulemaking.pdf [hereinafter Blumenthal Letter].
                 \20\ H.R. Rep. No. 108-318, at 4; FCLCA Subcomm. Hearing, supra
                note 17 (statements of Rep. W.J. Tauzin) (noting there is a
                ``classic conflict of interest that robs the consumers of the
                ability to shop competitively for the best price,'' and stating that
                the FCLCA takes the ``necessary steps to remedy this stranglehold on
                contact lens competition'').
                 \21\ 15 U.S.C. 7601-7610. The FCLCA passed with a vote of 406 in
                favor and 12 opposed in the House, and unanimous consent in the
                Senate.
                 \22\ Contact Lens Rule, 69 FR 40482 (July 2, 2004) (codified at
                16 CFR pt. 315). Pursuant to its congressional mandate, the FTC also
                issued a study of competition in the contact lens industry in 2005.
                See 2005 Contact Lens Report, supra note 14.
                ---------------------------------------------------------------------------
                 As specified in the Act, the Rule imposes requirements on both
                sellers and prescribers of contact lenses. Because the use of contact
                lenses involves significant health issues \23\ and Congress recognized
                that consumers may be harmed by contact lenses purchased with an
                expired, inaccurate, or otherwise invalid prescription,\24\ the Act
                requires that contact lenses be sold only to patients with valid
                prescriptions, which they receive after contact lens fittings by a
                prescriber. The Act and the Rule only allow sales of contact lenses
                when a patient presents a seller with a copy of the prescription or the
                seller has verified the patient's prescription with the prescriber.\25\
                Sellers also are prohibited from altering a contact lens
                prescription.\26\
                ---------------------------------------------------------------------------
                 \23\ See, e.g., FTC, ``Possible Barriers to E-Commerce: Contact
                Lenses, A Report from the Staff of the Federal Trade Commission'' 8-
                9 (2004), https://www.ftc.gov/sites/default/files/documents/advocacy_documents/possible-anticompetitive-barriers-e-commerce-contact-lenses-report-staff-ftc/040329clreportfinal.pdf.
                 \24\ Contact Lens Rule, 69 FR 40482.
                 \25\ 16 CFR 315.5(a).
                 \26\ 16 CFR 315.5(e).
                ---------------------------------------------------------------------------
                 The Act and the Rule further impose obligations on prescribers.
                First and foremost, prescribers are required to release a copy of the
                prescription to the patient promptly upon completion of the contact
                lens fitting, ``[w]hether or not requested by the patient.'' \27\
                Prescribers also are prohibited from requiring: (1) The purchase of
                contact lenses as a condition of either prescription release or
                verification, (2) a separate payment for prescription release or
                verification, and (3) that the patient sign a waiver as a condition of
                prescription release or verification.\28\
                ---------------------------------------------------------------------------
                 \27\ 15 U.S.C. 7601(a)(1); 16 CFR 315.3(a)(1).
                 \28\ 15 U.S.C. 7601(b)(1)-(3); 16 CFR 315.3(b)(1)-(3).
                ---------------------------------------------------------------------------
                 Additionally, prescribers are required to provide or verify a
                contact lens prescription when ``directed by any person designated to
                act on behalf of the patient.'' \29\ Such verification occurs when the
                seller provides the prescriber with a consumer's prescription
                information and: (1) The prescriber confirms that the prescription is
                accurate, by phone, facsimile, or electronic mail; (2) the prescriber
                informs the seller that the prescription is inaccurate and provides the
                correct prescription; or (3) the prescriber does not communicate with
                the seller within eight business hours of the seller's request for
                verification (``passive verification'').\30\ The eight-business-hour
                passive verification lessens the demands on prescribers in the event a
                seller forwards a query about an accurate and complete prescription
                from a properly identified patient. It also prevents prescribers from
                blocking verification--and impeding consumer access to contact lenses
                that may be lower-priced, or sold by sellers who offer other benefits
                or convenience--simply by refusing to respond to verification requests.
                ---------------------------------------------------------------------------
                 \29\ 15 U.S.C. 7601(a)(2); 16 CFR 315.3(a)(2).
                 \30\ 15 U.S.C. 7603(d)(1)-(3); 16 CFR 315.5.
                ---------------------------------------------------------------------------
                 One outcome of passive verification, however, is that, if a
                prescriber does not respond to a verification request containing
                inaccurate information or for an invalid prescription within eight
                business hours, the prescription is deemed verified; thus, passive
                verification allows for the possibility that patients can be sold
                lenses for which they do not have a valid prescription. Congress, when
                considering the FCLCA, was aware that a passive-verification regime
                could, in some instances, allow sellers to sell and ship contact lenses
                based on an invalid or inaccurate prescription, and that this could
                potentially lead to health risks.\31\ Congress opted for a passive-
                verification regime despite this concern in order ``to ensure that
                consumers are not caught in the competitive tug-of-war between doctors
                and third party sellers for the sale of contact lenses.'' \32\ It was
                also envisioned that prescribers would remain diligent in ensuring that
                patients did not receive lenses for which they had not been prescribed,
                since it is in both prescribers' self-interest and the health and
                safety interests of their patients to prevent this from occurring.\33\
                In this manner, the passive-verification system was perceived, to a
                certain extent, to be self-enforcing, as prescribers would have both a
                financial interest and an ethical duty to police invalid, incorrect, or
                expired prescriptions.\34\
                ---------------------------------------------------------------------------
                 \31\ See, e.g., FCLCA Subcomm. Hearing, supra note 17
                (statements of Howard Beales, Federal Trade Commission); id.
                (statements of J. Pat Cummings, American Optometric Association)
                (``And the problem with passive verification is that people will get
                contact lenses without a prescription.'').
                 \32\ H.R. Rep. No. 108-318, at 5.
                 \33\ Contact Lens Rule, 69 FR at 40498.
                 \34\ FCLCA Subcomm. Hearing, supra note 17 (statements of Howard
                Beales, Federal Trade Commission) (stating that passive verification
                is in many respects self-enforcing). See also id. (statements of
                Jonathan Coon, 1-800 CONTACTS) (explaining to the Committee that
                from their experience with an existing passive verification-system
                in California, doctors have motivation to block invalid-prescription
                sales. ``So they tell us if there is any problem with the
                prescription, if it's expired, it's invalid, whatever the problem is
                with the prescription. If they can tell us, you can believe they
                tell us absolutely every time.'').
                ---------------------------------------------------------------------------
                [[Page 50671]]
                C. Initial Request for Comments in 2015
                 As part of its periodic review of its rules and guides, on
                September 3, 2015, the Commission solicited comments on the Contact
                Lens Rule, seeking input on: The economic impact of, and continuing
                need for, the Rule; the benefits of the Rule to consumers purchasing
                contact lenses; the burdens the Rule places on entities subject to its
                requirements; the impact the Rule has had on the flow of information to
                consumers; the degree of industry compliance with the Rule; the need
                for any modifications to increase its benefits or reduce its burdens or
                to account for changes in relevant technology; and any overlap or
                conflict with the Rule and other federal, state, or local laws or
                regulations.\35\ The comment period for this initial request closed on
                October 26, 2015. The Commission received approximately 660 comments
                from individuals and entities representing a wide range of viewpoints,
                including prescribing eye-care practitioners (ophthalmologists and
                optometrists), opticians and other eye-wear industry members, sellers
                of contact lenses (both online and brick-and-mortar), contact lens
                manufacturers, and consumers.\36\
                ---------------------------------------------------------------------------
                 \35\ Contact Lens Rule Request for Comment (``RFC''), 80 FR
                53272 (Sept. 3, 2015).
                 \36\ Comment figures are approximations because identical
                comments are sometimes submitted more than once. RFC comments are
                available at https://www.ftc.gov/policy/public-comments/2015/09/initiative-621.
                ---------------------------------------------------------------------------
                D. Notice of Proposed Rulemaking in 2016
                 After a review of comments, surveys, other submitted information,
                and its own enforcement experience, the Commission determined that the
                overall weight of the evidence demonstrated a need to improve
                compliance with the Rule's automatic prescription-release requirement,
                as well as a need to create a mechanism for monitoring and enforcing
                the Rule.\37\ To achieve this, the Commission issued a Notice of
                Proposed Rulemaking (``NPRM'') on December 7, 2016 that proposed to add
                a signed-acknowledgment requirement.\38\ The signed-acknowledgment
                requirement was to be triggered once the prescriber presented the
                prescription to the patient, and the acknowledgment form could be in
                either paper or electronic format. As proposed, the acknowledgment form
                was to be entitled ``Patient Receipt of Contact Lens Prescription''
                (``Signed Acknowledgment''), and state, ``My eye care professional
                provided me with a copy of my contact lens prescription at the
                completion of my contact lens fitting. I understand that I am free to
                purchase contact lenses from the seller of my choice.'' Prescribers
                would be required to maintain copies of the acknowledgment forms in
                paper or electronically for not less than three years.
                ---------------------------------------------------------------------------
                 \37\ Notice of Proposed Rulemaking, 81 FR 88526 (Dec. 7, 2016)
                [hereinafter NPRM].
                 \38\ Id. The NPRM also proposed a technical amendment, to remove
                the words ``private label'' from Sec. 315.5(e) to conform the
                language of the Rule to that of the FCLCA.
                ---------------------------------------------------------------------------
                 The NPRM sought comment on this proposal as well as the following
                issues: The provision of additional copies of prescriptions, the amount
                of time for a prescriber to respond to such a request, the use of
                patient portals to release prescriptions, and potential modifications
                to address concerns about automated telephone verification calls. The
                sixty-day comment period for the Commission's NPRM closed on January
                30, 2017.
                 In response to its NPRM, the Commission received over 4,000
                additional comments, many from prescribers concerned about the impact
                of the proposed signed-acknowledgment requirement.\39\ After
                considering these and other comments, the Commission determined that
                certain issues deserved additional discussion and examination. To
                obtain additional input and more fully consider commenter concerns, the
                Commission solicited additional comments \40\ and held a public
                workshop on the Contact Lens Rule and the Evolving Contact Lens
                Marketplace on March 7, 2018. The workshop included six panels,
                covering issues relating to the overall contact lens marketplace,
                health and safety, competition, purchasing and verification, the
                proposed Signed Acknowledgment and consumer choice, and the future of
                contact lens prescribing and selling.\41\ In response to the
                Commission's request and workshop, the Commission received
                approximately 3,400 additional comments from a wide range of
                commenters, including numerous consumers and prescribers, as well as
                industry associations, state attorneys general, contact lens
                manufacturers, and contact lens sellers.\42\
                ---------------------------------------------------------------------------
                 \39\ NPRM comments available at https://www.ftc.gov/policy/public-comments/2016/10/initiative-677.
                 \40\ Public Workshop Examining Contact Lens Marketplace and
                Analyzing Proposed Changes to the Contact Lens Rule, 82 FR 57889
                (Dec. 8, 2017).
                 \41\ Workshop transcripts available at https://www.ftc.gov/news-events/events-calendar/2018/03/contact-lens-rule-evolving-contact-lens-marketplace.
                 \42\ Workshop comments available at https://www.ftc.gov/policy/public-comments/2018/01/initiative-733.
                ---------------------------------------------------------------------------
                E. Supplemental Notice of Proposed Rulemaking
                 After reviewing the comments submitted in response to the public
                workshop and Notice of Proposed Rulemaking, the Commission issued a
                Supplemental Notice of Proposed Rulemaking (``SNPRM'') on May 28, 2019
                that modified its previous proposal for a Signed Acknowledgment by
                instituting a more flexible Confirmation of Prescription Release
                provision.\43\ In addition, the SNPRM put forth new proposals to modify
                the Rule by: (a) Adding a definition of the term ``provide to the
                patient a copy,'' to allow the prescriber to provide the patient with a
                digital copy of the patient's prescription in lieu of a paper copy; (b)
                providing forty business hours as the time period for which a
                prescriber must provide a prescription upon request to a person
                designated to act on behalf of the patient; (c) creating new message
                delivery and recordkeeping requirements for sellers using automated
                telephone verification messages; (d) amending and clarifying the
                prohibition on seller alteration of prescriptions; and (e) requiring
                that sellers provide a method that would allow patients to present
                their prescriptions to the seller.
                ---------------------------------------------------------------------------
                 \43\ Supplemental Notice of Proposed Rulemaking, 84 FR 24664
                (May 28, 2019) [hereinafter SNPRM].
                ---------------------------------------------------------------------------
                 The Commission requested comment on its SNPRM proposal; the sixty-
                day comment period closed on July 29, 2019. In response to its SNPRM,
                the Commission received approximately 200 unique comments (and
                approximately 900 comments total) from a variety of stakeholders,
                including prescribers and prescriber-trade organizations, contact lens
                manufacturers, contact lens sellers, legislators, state attorneys
                general, economic think tanks and academics, consumer-interest
                organizations, and individual consumers themselves.\44\ The majority of
                commenters opined on the Confirmation of Prescription Release proposal,
                and many also commented on the Commission's new proposals regarding
                prescription verification and alteration. This Statement of Basis and
                Purpose for the Final Rule summarizes
                [[Page 50672]]
                the relevant comments received in response to the proposals set forth
                in the NPRM and SNPRM and explains the Commission's analyses and
                decisions to amend or not amend the Rule.
                ---------------------------------------------------------------------------
                 \44\ SNPRM comments available at https://www.regulations.gov/docket?D=FTC-2019-0041.
                ---------------------------------------------------------------------------
                II. Final Rule Pertaining to Confirmation of Prescription Release
                 The following sections discuss the Confirmation of Prescription
                Release proposal in the SNPRM, the comments to the SNPRM in support of
                and opposition to the Confirmation of Prescription Release proposal,
                the Commission's analysis and conclusions, and the amendments to the
                Final Rule instituting a Confirmation of Prescription Release. Because
                many of the comments focused on the Commission's basis for its SNPRM
                proposal, and whether that basis is supported by evidence in the
                record, the Commission also reiterates the basis set forth in the SNPRM
                and discusses related comments and subsequent determinations in this
                Statement of Basis and Purpose for the final amended Contact Lens Rule.
                 The Commission's authority to modify the Rule and implement a
                Confirmation of Prescription Release requirement derives from the
                FCLCA, which directed the FTC to prescribe implementing rules, and
                authorized the Commission to investigate and enforce the Act in the
                same manner, by the same means, and with the same jurisdictional powers
                and duties as a trade regulation rule under the Federal Trade
                Commission Act.\45\ Congress clearly intended that prescriptions be
                provided to all consumers at the completion of the contact lens fitting
                process.\46\ Survey evidence, the record of these proceedings, and the
                Commission's own experience with the Rule indicate that is not
                occurring at anywhere near the rate Congress intended. Consequently,
                the Commission believes that imposing a Confirmation of Prescription
                Receipt requirement is critical to effectuate congressional intent to
                the fullest extent.\47\
                ---------------------------------------------------------------------------
                 \45\ 15 U.S.C. 7601-7610 (Pub. L. 108-164).
                 \46\ 15 U.S.C. 7601; see also H.R. Rep. No. 108-318, at 4 (2003)
                (``The practice of optometrists withholding the prescription has
                limited the consumer's ability to shop for the best price and has
                [adversely] impacted competition.'').
                 \47\ See H.R. Rep. No. 108-318, at 6 (2003) (``The goal of this
                legislation is to allow consumer access to their contact lens
                prescriptions. . . .'').
                ---------------------------------------------------------------------------
                 In a comment to the NPRM, the American Optometric Association
                (``AOA'') contended that the Commission does not have the authority to
                add requirements to the Rule that are not found in the text of the
                FCLCA.\48\ According to the AOA, because the FCLCA is a statute that
                ``carefully enumerates specific substantive requirements but not
                others''--as opposed to a general grant of authority--the agency
                charged with administering the FCLCA ``should not add additional
                requirements that Congress did not enact.'' \49\
                ---------------------------------------------------------------------------
                 \48\ American Optometric Association (NPRM Comment #3830).
                 \49\ Id.
                ---------------------------------------------------------------------------
                 The Commission does not agree with this interpretation. As noted
                above, the FCLCA contains an express delegation of authority to the FTC
                to craft rules to carry out the Act.\50\ Pursuant to this delegation,
                the FTC has broad rulemaking authority to implement requirements for
                the purpose of preventing unfair or deceptive acts or practices in or
                affecting commerce, including failure to provide patients with copies
                of their prescriptions.\51\ The proposed modification requiring that
                patients sign a Confirmation of Prescription Release is consistent with
                the statute and falls well within the Commission's statutory
                jurisdiction under the FCLCA.\52\
                ---------------------------------------------------------------------------
                 \50\ 15 U.S.C. 7607.
                 \51\ See id. (directing the FTC to ``prescribe rules pursuant to
                section 57a of this title to carry out [the FCLCA]''); 15 U.S.C.
                57a(a)(1)(B) (authorizing the FTC to prescribe ``rules which define
                with specificity acts or practices which are unfair or deceptive
                acts or practices in or affecting commerce,'' including rules that
                contain ``requirements prescribed for the purpose of preventing such
                acts or practices''); 15 U.S.C. 7601(a) (mandating that when a
                prescriber completes a contact lens fitting, the prescriber
                ``whether or not requested by the patient, shall provide to the
                patient a copy of the contact lens prescription'').
                 \52\ 15 U.S.C. 7601(a), 7607. AOA's stance that a statute's
                enumeration of some requirements but not others necessarily
                signifies that Congress deliberately excluded the non-included
                requirements is also incorrect in the rulemaking context. It is well
                established that the canon of statutory interpretation expressio
                unius est exclusion alterius (``the expression of one is the
                exclusion of others'') does not have force in the administrative
                setting, where Congress is presumed to have left to reasonable
                agency discretion questions that it has not directly resolved. See
                Adirondack Med. Ctr. v. Sebelius, 740 F.3d 692, 697 (D.C. Cir.
                2014); St. Marks Place Hous. Co. v. U.S. Dep't of Hous. & Urban
                Dev., 610 F.3d 75 (D.C. Cir. 2010); AFL-CIO v. Chao, 409 F. 3d 377
                (D.C. Cir. 2005); Mobile Comm'cns Corp. of Am. v. FCC, 77 F.3d 1399,
                1404-05 (D.C. Cir. 1996); see also Farrell v. Pompeo, No. 17-490,
                2019 U.S. Dist. LEXIS 205831, *25-27 (D.C. Cir. Nov. 27, 2019).
                ---------------------------------------------------------------------------
                A. Proposed Modifications in the SNPRM
                 The SNPRM proposed to amend the NPRM's signed-acknowledgment
                proposal by replacing that requirement with a shorter and more flexible
                Confirmation of Prescription Release provision. Rather than requiring,
                as proposed in the NPRM, that prescribers request that each contact
                lens patient sign a form with mandatory language acknowledging receipt
                of the prescription and an understanding of the right to purchase
                lenses elsewhere,\53\ in the SNPRM the Commission proposed requiring
                prescribers instead to do one of the following:
                ---------------------------------------------------------------------------
                 \53\ NPRM, 81 FR at 88559 (The form would have stated: ``My eye
                care professional provided me with a copy of my contact lens
                prescription at the completion of my contact lens fitting. I
                understand I am free to purchase contact lenses from the seller of
                my choice.'').
                ---------------------------------------------------------------------------
                 (A) Request that the patient acknowledge receipt of the contact
                lens prescription by signing a separate statement confirming receipt of
                the contact lens prescription;
                 (B) Request that the patient sign a prescriber-retained copy of a
                contact lens prescription that contains a statement confirming receipt
                of the contact lens prescription;
                 (C) Request that the patient sign a prescriber-retained copy of the
                sales receipt for the examination that contains a statement confirming
                receipt of the contact lens prescription; or
                 (D) If a digital copy of the prescription was provided to the
                patient (via methods including an online portal, electronic mail, or
                text message), retain evidence that such prescription was sent,
                received, or made accessible, downloadable, and printable.\54\
                ---------------------------------------------------------------------------
                 \54\ SNPRM, 84 FR at 24667.
                ---------------------------------------------------------------------------
                 The Commission's proposal provided sample language for confirmation
                options (A), (B), and (C),\55\ but also allowed prescribers to craft
                their own wording of the signed confirmation for these options if they
                so desired. Unlike the NPRM's signed-acknowledgment proposal, which
                applied to all prescribers, the SNPRM's Confirmation of Prescription
                Release proposal only applied to prescribers with a financial interest
                in the sale of contact lenses.\56\
                ---------------------------------------------------------------------------
                 \55\ The Commission said it had no wish to burden prescribers
                with the task of formulating adequate confirmation language if they
                would prefer to use a sentence from the language the Commission
                previously proposed: ``My eye care professional provided me with a
                copy of my contact lens prescription at the completion of my contact
                lens fitting.'' The Commission said use of such language would
                satisfy the proposed requirement. SNPRM, 84 FR at 24683.
                 \56\ Id.
                ---------------------------------------------------------------------------
                B. Basis for SNPRM Confirmation of Prescription Release Proposal
                 The Commission explained in the SNPRM that it based its
                Confirmation of Prescription Release proposal on a variety of evidence,
                including: Multiple consumer surveys consistently showing prescriber
                non-compliance with, and lack of consumer awareness of, the Rule's
                prescription-release requirement; numerous accounts of prescribers'
                failure to release prescriptions; the
                [[Page 50673]]
                persistently high number of verifications, many of which would be
                unnecessary were consumers in possession of their prescriptions; the
                regulatory structure of the contact lens market, which requires a
                consumer to obtain lenses pursuant to a prescription while permitting
                prescribers to sell what they prescribe; and the lack of credible
                empirical evidence rebutting or contradicting the evidence that
                prescribers are not automatically releasing prescriptions, and that
                consumers are not fully aware of their rights.\57\ The Commission also
                noted that the potential benefit of increasing the number of patients
                in possession of their prescriptions is substantial for consumers,
                sellers, and prescribers: Namely, increased flexibility and choice for
                consumers; a reduced verification burden for prescribers and sellers;
                and a reduced likelihood of errors associated with incorrect, invalid,
                and expired prescriptions and, consequently, improved patient
                safety.\58\ The Commission further explained that it faces serious
                challenges enforcing the Rule and monitoring compliance because it
                often comes down to the word of the patient against the word of the
                prescriber, which might require the Commission to issue administrative
                subpoenas and conduct investigational hearings--which could be
                resource-intensive for the Commission and costly, time-consuming, and
                disruptive for prescribers--in order to investigate each potential
                violation.\59\ The Commission thus concluded that some form of retained
                documentation is necessary to improve its ability to enforce and
                monitor prescriber compliance with the prescription-release
                requirements.\60\
                ---------------------------------------------------------------------------
                 \57\ Id. at 24680-81.
                 \58\ Id. at 24681.
                 \59\ Id.
                 \60\ Id.
                ---------------------------------------------------------------------------
                 The Commission also determined that signage--an alternative
                suggested by NPRM commenters--was not an appropriate or effective means
                of ensuring that patients receive their prescriptions as required by
                law.\61\ Lastly, the Commission determined that despite commenter
                concerns, the burden to obtain signatures and retain records would be
                relatively minimal and outweighed by the benefits.\62\ The Commission,
                however, was receptive to an NPRM commenter recommendation to modify
                the signed-acknowledgment proposal in order to further reduce the
                burden and allow for greater flexibility,\63\ and thus the SNPRM's
                Confirmation of Prescription Release proposal included three new
                options for prescribers to obtain or establish proof of prescription
                release and exempted prescribers who lacked a financial interest in the
                sale of contact lenses.\64\ According to the Commission, the
                Confirmation of Prescription Release proposal retained most of the
                benefits of the NPRM's signed-acknowledgment proposal, but would be
                less disruptive and burdensome for prescribers.\65\
                ---------------------------------------------------------------------------
                 \61\ Id.
                 \62\ Id. at 24681-82.
                 \63\ The recommendation was submitted by the National
                Association of Optometrists and Opticians in its comments to the
                Contact Lens Workshop and the NPRM, see id. at 24680 (citing
                National Association of Optometrists and Opticians (WS Comment
                #3208)).
                 \64\ SNPRM, 84 FR at 24683.
                 \65\ Id.
                ---------------------------------------------------------------------------
                C. Comments on the Confirmation of Prescription Release Proposal and
                the Basis for Such Proposal
                 Commenter response to the Commission's proposal in the SNPRM was
                varied. Some commenters applauded the proposed amendments as
                improvements to the prior signed-acknowledgment proposal, and as a
                balanced response to competing interests of consumers, sellers, and
                prescribers.\66\ Some, for instance, praised the confirmation proposal
                as an attempt to increase consumer access to prescriptions while making
                it easier and more efficient for prescribers to adhere to the patient-
                acknowledgment requirement by allowing flexible methods for obtaining
                the patient's signature.\67\ Other commenters, however, asserted that
                the proposal watered down prescriber obligations and would thus be less
                effective than the NPRM's signed-acknowledgment proposal in ensuring
                that consumers receive their prescriptions and are aware of their
                rights.\68\ And several commenters, primarily contact lens prescribers,
                stated that despite the increased flexibility, the Confirmation of
                Prescription Release proposal still created too much of a burden for
                prescribers, and they criticized the Commission's approach and the
                evidence relied upon.\69\
                ---------------------------------------------------------------------------
                 \66\ R Street Institute (SNPRM Comment #15) (``The Commission's
                proposal is both reasonable and not overly burdensome.''); Grimm
                (SNPRM Comment #36) (``There is no doubt that the modified Contact
                Lens Rule should be embraced by prescribers, sellers, and consumers
                as an improvement to consumer products trade rules.''); Americans
                for Tax Reform (SNPRM Comment #72) (``These changes strike the
                correct balance between promoting the free market and protecting
                important consumer rights.''); Lens.com (SNPRM Comment #85) (``We
                believe you have struck the correct balance . . . .''); Coalition
                for Contact Lens Consumer Choice (SNPRM Comment #89) (``What the FTC
                is proposing is a common sense, minimally-burdensome rule that
                optometrists, ophthalmologists, and consumers alike can and should
                support.''); Taxpayers Protection Alliance (SNPRM Comment #118)
                (``Although we are often critical of government overreach and work
                hard to make government smaller, we believe that the FTC's proposed
                Contact Lens Rule is a government rule that works for taxpayers and
                consumers and creates an open transparent contact lens market in the
                US where taxpayers have real choice and there is real competition in
                the marketplace.''); Attorneys General of 27 States (SNPRM Comment
                #139) (``We believe the proposed modifications in the SNPRM are
                reasonable modifications that balance the interests of consumers,
                eye care professionals, and the eye care industry.'').
                 \67\ Anonymous (SNPRM Comment #63); Rawson (SNPRM Comment #68)
                (``This proposed rule allows prescribers the ability to model the
                rule to best fit their practice, but still give the consumers the
                protection and the knowledge they need.'').
                 \68\ Consumer Reports (SNPRM Comment #133); 1-800 CONTACTS
                (SNPRM Comment #135).
                 \69\ American Optometric Association (SNPRM Comment #96); Reeder
                (SNPRM Comment #55) (even signature on prescription or patient
                receipt is burdensome); Kegler (SNPRM Comment #99) (proposal will
                still place financial and administrative burdens on prescribers).
                ---------------------------------------------------------------------------
                1. Comments About the Need for the Confirmation of Prescription Release
                and Whether Prescribers Are Complying With the Rule's Automatic
                Prescription Release Requirement
                a. Survey Evidence as Proof of Non-Compliance
                 Many of the SNPRM comments focused on the need for a Signed
                Acknowledgment or Confirmation of Prescription Release, and on whether
                evidence in the record supports the Commission's determination that
                prescribers are not complying with the Rule's prescription-release
                requirement. Several commenters, such as 1-800 CONTACTS, Consumer
                Action, and the Attorneys General of Twenty-Seven States, contended (as
                they did in comments responding to either the NPRM, the Contact Lens
                Workshop, or both) \70\ that prescriber noncompliance remains a
                problem, and that millions of Americans are not receiving their
                prescriptions after a contact lens fitting.\71\ The Attorneys General
                of Twenty-Seven States, for instance, commented that consumers in their
                states continue to report that prescribers are failing to automatically
                provide patient prescriptions in writing.\72\ Likewise, the online
                seller 1-800 CONTACTS submitted a new survey of consumers, conducted
                for it by the
                [[Page 50674]]
                polling firm Dynata (formerly known as Survey Sampling International),
                showing that prescriber compliance has not markedly improved, despite
                the attention focused on automatic-prescription-release obligations
                since the FTC initiated its rule review in 2015.\73\ According to the
                new survey, nearly 49% of contact lens patients report that their
                prescribers did not automatically give them their prescription after
                their eye examination.\74\ Of those who did not receive their
                prescription automatically, a little more than half received it after
                requesting it, while 43% never received their prescription.\75\
                Extrapolating this data to the general population of 45 million U.S.
                contact lens users \76\ would mean there are approximately 22 million
                annual violations of the Contact Lens Rule, and that each year more
                than 9.4 million contact lens users do not receive their
                prescriptions.\77\ The 2019 consumer survey data is consistent with
                several prior surveys of contact lens users conducted in 2014, 2015,
                2016, and 2017 on behalf of 1-800 CONTACTS and the consumer rights
                organization Consumer Action,\78\ as well as a survey of eyeglass
                wearers (who, per the FTC's Eyeglass Rule, are also to automatically
                receive their prescriptions following a refractive eye exam) conducted
                on behalf of Warby Parker in 2015.\79\
                ---------------------------------------------------------------------------
                 \70\ See 1-800 CONTACTS (NPRM Comment #3898); 1-800 CONTACTS (WS
                Comment #3207); Consumer Action (NPRM Comment #3721); Comments of
                the Attorneys General of 20 States (NPRM Comment #3804).
                 \71\ 1-800 CONTACTS (SNPRM Comment #135); Attorneys General of
                27 States (SNPRM Comment #139).
                 \72\ Attorneys General of 27 States (SNPRM Comment #139).
                 \73\ 1-800 CONTACTS (SNPRM Comment #135).
                 \74\ 1-800 CONTACTS (SNPRM Comment #135, Ex. B). The poll was of
                1011 contact lens users between the ages of 18-49, and the relevant
                questions asked were ``At your last eye exam, did the eye care
                provider provide you with a copy of your contact lens
                prescription?'' and ``In order to obtain a copy of your
                prescription, did you have to ask your eye care provider for it?''
                Approximately 41% said they received it automatically, 49% said they
                did not, and 10% did not recall or were unsure.
                 \75\ Id.
                 \76\ Centers for Disease Control, Healthy Contact Lens Wear and
                Care, Fast Facts, https://www.cdc.gov/contactlenses/fast-facts.html.
                 \77\ This is based on the estimate--long used to calculate the
                financial burden of the Rule for Paperwork Reduction Act purposes--
                that consumers obtain one contact lens prescription per year. See,
                e.g., SNPRM, 84 FR at 24692; Paperwork Reduction Act Proposed
                Collection; Comment Request, 81 FR at 31940; Paperwork Reduction Act
                Proposed Collection; Comment Request, 78 FR at 9392.
                 \78\ SNPRM, 84 FR at 24671-72.
                 \79\ NPRM, 81 FR at 88531.
                ---------------------------------------------------------------------------
                 Some commenters also pointed to previously-submitted evidence
                indicating that many U.S. contact lens users are still unaware of their
                right to automatically receive their prescriptions and take them
                elsewhere for filling.\80\ While commenters to the SNPRM did not submit
                updated polling data on consumer awareness, several cited previously-
                submitted data indicating that between 46-60% of consumers are unaware
                that under federal law a prescriber is required to provide the patient
                with a copy of their prescription after they complete their contact
                lens exam.\81\
                ---------------------------------------------------------------------------
                 \80\ Coalition for Contact Lens Consumer Choice (SNPRM Comment
                #89); Consumer Action (SNPRM Comment #101); 1-800 CONTACTS (SNPRM
                Comment #135).
                 \81\ Consumer Action (SNPRM Comment #101) (``Our survey showed a
                fundamental lack of understanding by consumers about their automatic
                right to receive a copy of their prescription''); 1-800 CONTACTS
                (SNPRM Comment #135); see SNPRM 84 FR at 24672 (discussing polls of
                consumer knowledge of their rights).
                ---------------------------------------------------------------------------
                 Another commenter, the National Hispanic Medical Association
                (``NHMA''), noted that polls show that Hispanic patients are
                disproportionately impacted by prescribers' failure to release
                prescriptions, and are less likely to understand their rights under the
                FCLCA.\82\ According to the NHMA, ``Our community continually has been
                victimized and denied their prescriptions by prescribers and doctors at
                a higher rate than most other Americans. We strongly believe that more
                must be done to ensure patients are informed of their rights and given
                copies of their prescriptions.'' \83\
                ---------------------------------------------------------------------------
                 \82\ National Hispanic Medical Association (SNPRM Comment #146).
                 \83\ Id.
                ---------------------------------------------------------------------------
                 A number of SNPRM commenters, however, were critical of the polling
                data provided to, and relied upon by, the Commission. The American
                Academy of Ophthalmology (``AAO'') asserted that data showing
                prescriber non-compliance consisted of ``industry-sponsored surveys''
                and was therefore unreliable.\84\ AAO added that it is ``unaware of
                issues'' with prescribers failing to release prescriptions, and stated
                its members ``know that ophthalmology has a strong record of
                compliance.'' \85\ Likewise, the American Society of Cataract and
                Refractive Surgery (``ASCRS'') asserted that there is no independent
                third-party evidence suggesting physicians are not providing
                prescriptions to patients, and that the Commission is basing compliance
                on ``survey polls sponsored by stakeholders with financial interest in
                the sale of contact lenses.'' \86\ According to the ASCRS, before
                amending the Rule, the Commission should obtain data from a
                disinterested organization.\87\
                ---------------------------------------------------------------------------
                 \84\ American Academy of Ophthalmology (SNPRM Comment #136).
                 \85\ Id.
                 \86\ American Society of Cataract and Refractive Surgery (SNPRM
                Comment #127).
                 \87\ Id.
                ---------------------------------------------------------------------------
                 The AOA was highly critical of polling data supplied by 1-800
                CONTACTS, and stated that since the online seller, in its advertising,
                encouraged consumers to ``skip the trip to the optometrist'' and
                instead renew prescriptions online (via telemedicine), the online
                seller has a demonstrated bias against optometrists that taints the
                material it submits.\88\ The AOA further stated that some consumer
                survey findings may be misleading because it is ``very typical'' for
                consumers to request their prescriptions before their contact lens
                fitting is complete, and thus before prescribers are obligated--under
                the Rule and the FCLCA--to release them to consumers.\89\ Therefore,
                some consumers might indicate on a survey that they were required to
                ask for their prescriptions when, in fact, they asked before they were
                entitled to receive them. As support for this contention, AOA stated
                that it surveyed some of its members and found that 91.7% ``indicated
                that there are times when a patient will ask for his/her prescription
                prior to the finalization of the contact lens fitting.'' \90\
                ---------------------------------------------------------------------------
                 \88\ American Optometric Association (SNPRM Comment #96).
                 \89\ Id.
                 \90\ Id. The AOA reported this result in its comment, and it
                stated that its survey was of 629 prescribers, but did not provide
                the FTC with the underlying survey data, information about the
                manner in which the survey was conducted, how the 629 prescribers
                were selected, or the specific questions that were asked.
                ---------------------------------------------------------------------------
                 The Commission recognizes that some consumers may think they had to
                ask for their prescriptions when, in fact, they would have received
                them when their fittings were complete. However, the AOA did not
                suggest, nor provide any data or information, as to how often this may
                occur, and thus how much it might skew the results of consumer surveys.
                As a result, the Commission is unable to estimate what portion of the
                49% who stated they did not automatically receive their prescription--
                in the most recent survey--gave that response because they
                misunderstood when they were entitled to receive their
                prescription.\91\
                ---------------------------------------------------------------------------
                 \91\ The Commission also notes that eyeglass patients are
                entitled to their prescriptions immediately following their exam
                (since they do not have to wait for a fitting), and thus would
                rarely ask for their prescriptions before they are entitled to them,
                and yet two 2015 surveys of eyeglass wearers--one on behalf of Warby
                Parker, the other for 1-800 CONTACTS--found that 47% and 66%,
                respectively, of eyeglass patients who visited an optometrist
                reported that they were not automatically provided a prescription at
                the end of their exam. NPRM, 81 FR at 88531 (citing Warby Parker
                (Comment #813 on the Ophthalmic Practice Rule), available at https://www.ftc.gov/policy/public-comments/initiative-624); 1-800 CONTACTS
                (RFC Comment #568, Ex. B). This would seem to indicate that most
                consumer reports that they did not receive their prescriptions are
                not based on a misunderstanding of when they are supposed to receive
                them.
                ---------------------------------------------------------------------------
                [[Page 50675]]
                 Moreover, even if the Commission were to disregard evidence of
                consumers who obtained their prescriptions only after asking for them,
                five consumer surveys from 2015 to 2019 (six if the Warby Parker
                eyeglass wearers' survey is included) indicate that between 21%-36% of
                consumers--approximately 9.5 to 16.2 million contact lens users each
                year--did not receive their prescriptions at all after getting fitted
                for their lenses.\92\ This level of non-compliance on its own supports
                the Commission's recommendation.
                ---------------------------------------------------------------------------
                 \92\ This approximation is based on the current estimate that
                there are 45 million contact lens users in the United States.
                Centers for Disease Control, Healthy Contact Lens Wear and Care,
                Fast Facts, https://www.cdc.gov/contactlenses/fast-facts.html. The
                results from the individual surveys are as follows: (1) June 2019
                survey by Dynata on behalf of 1-800 CONTACTS of 1011 contact lens
                users found that 21% said they never received their prescriptions
                (1-800 CONTACTS (SNPRM Comment #135)); (2) January 2017 survey by
                Caravan ORC International on behalf of Consumer Action of 2018
                adults found that 31% of contact lens users said that at their last
                eye exam, their doctor did not provide them with a paper copy of
                their prescription (Consumer Action (NPRM Comment #3721)); (3)
                December 2016 survey of 1000 contact lens users by Survey Sampling
                International (``SSI'') on behalf of 1-800 CONTACTS found that 24%
                of consumer respondents said they did not receive their prescription
                (1-800 CONTACTS (NPRM Comment #3898)); (4) October 2015 SSI survey
                of 500 contact lens users and 303 eyeglass users on behalf of 1-800
                CONTACTS found that 36% of contact lens users and 39% of eyeglass
                wearers said they did not receive their prescription (1-800 CONTACTS
                (RFC Comment #568, Ex. B)); (5) May 2015 SSI survey of 2000 contact
                lens wearers found that 34% said they did not receive their
                prescription (1-800 CONTACTS (RFC Comment #568, Ex. C)); and
                (6)November 2014 SSI survey of 2000 contact lens wearers found that
                34% said they did not receive their prescription (1-800 CONTACTS
                (RFC Comment #568, Ex. C)). As noted in the SNPRM, the manner in
                which a few of the questions were phrased in the 2014 and 2015
                surveys raised some Commission concerns, since some questions were
                leading, lacked an ``I don't know'' response option, and used a
                term--``hard copy''--which not all consumers may understand. The
                more recent surveys represented an improvement because they included
                an option for respondents to acknowledge that they do not recall
                whether they received their prescriptions, and used the term ``paper
                copy'' rather than ``hard copy.'' SNPRM, 84 FR at 24672.
                ---------------------------------------------------------------------------
                 As for commenter criticism that consumer surveys were submitted by
                interested parties, the Commission reiterates what it stated in the
                SNPRM: while cognizant of the interests of submitting parties, the
                Commission, whenever possible, examines the underlying survey data and
                methodology to gauge a survey's usefulness and considers factors such
                as how many people are queried, how the questions are phrased, and
                whether the surveys are conducted in-house or by independent and
                established third-party polling firms.\93\ The Commission also
                recognizes that all surveys may have methodological limitations, and,
                in this instance, does not treat any one survey as controlling. The
                Commission, however, also recognizes that multiple surveys conducted by
                different sources at different times with similar results bolster the
                credibility of each individual survey, as does the fact that in this
                matter, one survey, submitted by Consumer Action and conducted by the
                third-party polling firm Caravan ORC International, is not from a party
                with a direct financial stake in the contact lens industry.\94\
                ---------------------------------------------------------------------------
                 \93\ SNPRM, 84 FR at 24672.
                 \94\ The AOA had previously noted, in response to the NPRM, that
                Consumer Action has received corporate financial support from, among
                others, 1-800 CONTACTS. Id. Consumer Action, however, is a long-
                established non-profit consumer advocacy organization without a
                financial interest in the outcome of this Rule review.
                ---------------------------------------------------------------------------
                 The Commission also notes that despite multiple opportunities and
                requests for comment since 2015, the Commission has yet to find or
                receive any reliable consumer-survey data rebutting or contradicting
                the submitted survey findings, or establishing that consumers
                consistently receive their prescriptions. The only empirical evidence
                of prescriber compliance in the record is a survey of fifty-seven
                ``high volume'' prescribers submitted by AOA in response to the NPRM,
                which found that 93% responded ``yes'' when asked, ``Do you follow
                Federal law and provide patients with a copy of their contact lens
                prescription upon completion of a contact lens fitting?'' \95\ For the
                reasons stated in the SNPRM,\96\ the Commission does not accord this
                survey significant weight, and finds that it does not counter the
                multiple consumer surveys conducted over a number of years showing
                prescriber non-compliance. The Commission accords the empirical data
                from multiple consumer surveys significant weight in establishing that
                a substantial percentage of prescribers are not complying with the
                automatic-prescription-release provision of the Rule.
                ---------------------------------------------------------------------------
                 \95\ SNPRM, 84 FR at 24672; American Optometric Association (WS
                Comment #3303, Ex. B). This survey appears to have been conducted by
                the AOA itself rather than an outside polling firm. It is not clear
                from the AOA's submission how the fifty-seven optometrists were
                selected for the survey, what it means to be a ``high volume''
                optometrist, or why high-volume optometrists were chosen.
                 \96\ SNPRM, 84 FR at 24673 (noting concerns about the small
                sample size, lack of detail as to how prescriber respondents were
                recruited, and that the way the question is phrased allows
                prescribers to truthfully answer that they provide patients with a
                copy of their prescription even if they do not do so for every
                patient, and even if they only do so when the patient requests one).
                ---------------------------------------------------------------------------
                 Apart from the empirical data discussed above, none of the
                commenters submitted new evidence relating to prescriber compliance.
                Many individual prescribers, however, continue to comment that they
                always comply with the requirement, as do all the prescribers they
                know, and therefore they believe that the Commission is looking to
                solve a non-existent problem.\97\ Some prescribers also reiterated
                that, in their experience, consumers are well aware that they can buy
                lenses elsewhere so there is no need to educate them further about
                their rights.\98\ And a few prescribers opined that the requirement was
                a ``waste of time'' because, in their experience, consumers would
                rather not have a copy of their prescription and know that they can
                request a copy whenever they want.\99\
                ---------------------------------------------------------------------------
                 \97\ See, e.g., Abert (SNPRM Comment #20); Hyndman (SNPRM
                Comment #21) (``every OD I know follows'' the FCLCA requirements);
                Fair (SNPRM Comment #26) (``I have ALWAYS and will continue to
                comply fully with the prescription release requirements of the 2003
                Fairness to Contact Lens Consumers Act.''); Hughes (SNPRM Comment
                #113) (most optometrists comply); Ridder (SNPRM Comment #720) (every
                patient gets their prescription whether they order or ask for it or
                not).
                 \98\ Abert (SNPRM Comment #20); Jones (SNPRM Comment #48).
                 \99\ Sikes (SNPRM Comment #114); Morey (SNPRM Comment #142).
                ---------------------------------------------------------------------------
                 The Commission has considered these comments but does not believe
                they establish that prescribers, on the whole, are complying with the
                automatic-release requirement, or that consumers are fully aware of
                their prescription-portability rights. Any prescriber may indeed comply
                with the Rule but cannot speak for other eye care providers in the
                United States, nor for contact lens consumers.\100\ In addition,
                several previous comments from prescribers and prescriber organizations
                who assert that they comply with the Rule actually revealed that many
                prescribers do not fully understand or comply with the Rule's
                requirement that prescriptions be provided ``whether or not requested
                by the patient.'' \101\
                ---------------------------------------------------------------------------
                 \100\ By one estimate, there are approximately 43,000
                optometrists and 16,700 ophthalmologists in the U.S. FTC, The
                Contact Lens Rule and the Evolving Contact Lens Marketplace, Panel
                I: Overview of the Contact Lens Marketplace Tr. at 6 (Mar. 7, 2018),
                https://www.ftc.gov/system/files/documents/public_events/1285493/panel_i_overview_of_the_contact_lens_marketplace.pdf [hereinafter
                CLR Panel I Tr.].
                 \101\ See SNPRM, 84 FR at 24673-74, discussing how a number of
                prescribers commented that they always offer prescriptions to
                consumers, or provide them on request.
                ---------------------------------------------------------------------------
                 The Commission does not accord any weight to the comments that
                consumers do not want their prescriptions. As
                [[Page 50676]]
                evidenced by the numerous NPRM comments from consumers urging the
                Commission to take action to ensure they are given their prescriptions,
                it cannot be doubted that many consumers have a compelling desire to
                have them.\102\ And more importantly, Congress made the determination
                that prescribers must provide patients with their prescriptions
                automatically, ``whether or not requested by the patient.'' \103\
                ---------------------------------------------------------------------------
                 \102\ See, e.g., Boue (NPRM Comment #1806); Collins (NPRM
                Comment #1811); Hamilton (NPRM Comment #1835); Acton (NPRM Comment
                #2070); Dunbar (NPRM Comment #2652); Capuano (NPRM Comment #2722);
                Muckley (NPRM Comment #2768); Taravella (NPRM Comment #2892);
                Martinez (NPRM Comment #2894); Ballou (NPRM Comment #3331). See also
                SNPRM, 84 FR at 24671 (recounting comments from dozens of consumers
                complaining that they were denied their prescriptions).
                 \103\ FCLCA, 15 U.S.C. 7601(a)(1).
                ---------------------------------------------------------------------------
                b. Lack of Consumer Complaints as Evidence of Compliance
                 Some commenters reiterated the argument--raised and discussed in
                some detail in the SNPRM \104\--that the lack of consumer complaints to
                the FTC about prescriber non-compliance is evidence that prescribers
                are releasing prescriptions as required.\105\ In the SNPRM, the
                Commission explained that it did not equate the lack of complaints with
                compliance because based on its experience, the vast majority of
                injured or impacted consumers do not register complaints with the
                government and, for various reasons, even fewer are likely to file a
                formal complaint about a prescriber's failure to release their
                prescription.\106\ The Commission also noted that more than fifty
                consumers submitted comments to the NPRM recounting personal stories of
                prescribers withholding their prescriptions, yet none of these
                commenters had previously registered complaints with the FTC.\107\
                ---------------------------------------------------------------------------
                 \104\ SNPRM, 84 FR at 24674-75.
                 \105\ Letter from Sens. Jack Reed and Sheldon Whitehouse (SNPRM
                Comment #6); Mass Mail Campaign (SNPRM Comment #25); Hanian (SNPRM
                Comment #27); Letter from 20 U.S. Senators (SNPRM Comment #38);
                Letter from Sen. Lisa Murkowski (SNPRM Comment #49); Levinson (SNPRM
                Comment #73); Cinalli (SNPRM Comment #93).
                 \106\ SNPRM, 84 FR at 24674-75.
                 \107\ Id. at 24675.
                ---------------------------------------------------------------------------
                 In response, the AOA commented that if complaints to the FTC are
                not a good bellwether of prescriber compliance because consumers are
                unlikely to file formal complaints, the FTC should simplify and improve
                its complaint-reporting system.\108\ The AOA deemed it unfair for the
                Commission to rely on consumer survey data as evidence of prescribers'
                failure to release prescriptions, but not rely on the absence of
                consumer complaints as evidence that prescribers are automatically
                providing prescriptions.\109\ The AOA stated the Commission should make
                an effort to make consumer complaint data--or lack thereof--more
                representative by providing a dedicated FCLCA complaint line for
                contact-lens-related issues.\110\ At the same time, however, the AOA
                stated that since ``it is very typical'' for patients to ask for their
                prescription before their contact lens fitting is complete, consumer
                complaints cannot necessarily be viewed as accurate indications of non-
                compliance.\111\
                ---------------------------------------------------------------------------
                 \108\ American Optometric Association (SNPRM Comment #96).
                 \109\ Id.
                 \110\ Id.
                 \111\ Id.
                ---------------------------------------------------------------------------
                 The Commission does not find these arguments persuasive. As noted
                in the SNPRM, the Commission has gleaned, through its extensive
                experience with consumer complaints and deceptive practices, that the
                vast majority of injured or impacted consumers do not file complaints
                with the government.\112\ And with the exception of the Telemarketing
                Sales Rule (often referred to as ``Do Not Call''), consumer complaints
                about FTC rule violations are rarer still, perhaps because they require
                that consumers know what an FTC rule specifies and how it has been
                violated.\113\ While the Commission continues to regard consumer
                complaints as valuable and informative, they often represent the tip of
                the iceberg.
                ---------------------------------------------------------------------------
                 \112\ SNPRM, 84 FR at 24675. Consumer reticence to complain,
                particularly to a government entity, is well documented. As one
                example, an FTC survey revealed that in 2017 there were an estimated
                61.8 million incidents of fraud in the United States with
                approximately 40 million individual victims and average losses of
                $100 or more, yet the FTC received just 1.2 million complaints of
                fraud from consumers, approximately 1.9% of all incidents. Keith B.
                Anderson, FTC, ``Mass Market Consumer Fraud in the United States, A
                2017 Update,'' 24, 56 (Oct. 2019); FTC, ``Consumer Sentinel Network
                Data Book 2017,'' Number of Reports by Type, https://www.ftc.gov/site-information/open-government/data-sets#csn. It is likely these
                figures actually overstate the percentage of frauds reported to the
                FTC, since the FTC's fraud surveys are limited to specific types of
                fraud, while there is no such limitation on complaints of fraud from
                consumers. See also Keith B. Anderson, FTC, ``Consumer Fraud in the
                United States: An FTC Survey'' 80 (2004), http://www.ftc.gov/reports/consumer-fraud-united-states-ftc-survey, (indicating that
                only 8.4% of U.S. fraud victims complained to an official source,
                with only 1.4% complaining to the FTC); Marc A. Grainer et al.,
                ``Consumer Problems and Complaints: a National View,'' 6 Advances in
                Consumer Res. 494 (1979) (noting that ``only a small, vocal minority
                of consumers complain about the problems they experience,'' and even
                fewer (less than 10% of complaints) complain to the government),
                http://acrwebsite.org/volumes/9603/volumes/v06/NA-06; John Goodman &
                Steve Newman, ``Understand Customer Behavior and Complaints,''
                Quality Progress, Jan. 2003, at 51 (finding that for problems that
                resulted in a relatively minor inconvenience or a small loss of
                money, only 3% of consumers complained), http://web.ist.utl.pt/
                ~ist11038/CD_Casquilho/PRINT/qp0103goodman.pdf.
                 \113\ See generally, FTC, ``Consumer Sentinel Network Data Book
                2017,'' Number of Reports by Type, https://www.ftc.gov/site-information/open-government/data-sets#csn. FTC, ``Consumer Sentinel
                Network Data Book for January-December 2016'' (2017), https://www.ftc.gov/system/files/documents/reports/consumer-sentinel-network-data-book-january-december-2016/csn_cy-2016_data_book.pdf.
                ---------------------------------------------------------------------------
                 Furthermore, for reasons discussed in detail in the NPRM, the
                Commission does not believe its complaint-reporting system bears
                principal responsibility for the shortage of complaints about
                prescriber violations of the Contact Lens Rule.\114\ While the FTC does
                not have a dedicated complaint system solely for FCLCA violations, as
                sought by the AOA, the FTC Complaint Assistant is configured to capture
                and report all contact lens-related complaints, whether they originate
                from consumers, prescribers, sellers, or others.\115\
                ---------------------------------------------------------------------------
                 \114\ NPRM, 81 FR at 88554-55.
                 \115\ The Commission also notes that if, as the AOA asserts,
                some consumers would complain that they did not receive their
                prescriptions before they were, in fact, entitled to them, creating
                a dedicated system for FCLCA complaints would not make the number of
                complaints any more or less reflective of prescriber compliance.
                ---------------------------------------------------------------------------
                 More to the point, multiple surveys have established that a high
                percentage of contact lens wearers (46-60%, according to submitted
                data) do not realize they are entitled to receive their
                prescription,\116\ and thus would not be aware that an incident about
                which they should complain had occurred. Many other consumers might be
                unaware of where to direct a complaint when they do not receive a
                prescription. Even consumers who are aware that they have a right to
                their prescription, and know they can file a complaint with the FTC,
                may be unlikely to file one if they ultimately receive their
                prescription after they have asked their provider for it. From the
                consumers' perspective, they have resolved their problem and may
                perceive little benefit to themselves from filing a complaint with the
                government, even if the method for filing one was more streamlined or
                convenient. Consumers may also not want to risk antagonizing their
                providers or subjecting them to legal penalties. Thus, for evaluating
                Contact Lens Rule compliance, the Commission has considered the low
                rate of consumer complaints filed with the FTC's Complaint Assistant,
                but remains convinced this is less probative of the
                [[Page 50677]]
                scope of the problem than other evidence.\117\
                ---------------------------------------------------------------------------
                 \116\ SNPRM, 84 FR at 24675.
                 \117\ Consumer surveys may also be more reliable since consumers
                questioned at random are less likely to have a personal interest in
                stating that they did not receive their prescription.
                ---------------------------------------------------------------------------
                c. Number of Verifications as Evidence of Non-Compliance With the
                Automatic Prescription Release Requirement
                 In the SNPRM, the Commission noted that it would accord the number
                of verifications less weight than it had in the NPRM as evidence of
                prescriber non-compliance out of a recognition that some consumers--
                even if in possession of their prescription--may find it easier to type
                in their specifications than present a prescription to the seller, and
                because some online contact lens sellers do not have a mechanism for
                consumers to present their prescriptions.\118\ In its comment to the
                SNPRM, the AOA contended that the high number of verifications should
                not be accorded any weight at all for those reasons. As additional
                support for this contention, the AOA cited internal prescriber
                complaint data showing that the percentage of prescriber complaints
                about ``problematic verification calls'' has increased from roughly 6%
                to 17% in the past four years; it attributed much of this increase to
                the emergence of an online seller that does not permit patient
                prescription presentation.\119\ According to the AOA, the increase in
                complaints about verification, and the high percentage of such
                complaints about the online seller, demonstrate that a ``high volume of
                verification calls are occurring based on a prescription that was never
                written,'' and therefore the number of verification calls is ``simply
                not an appropriate measure for assessing contact lens prescription
                requirements and should be afforded no weight.'' \120\
                ---------------------------------------------------------------------------
                 \118\ SNPRM, 84 FR at 24674.
                 \119\ American Optometric Association (SNPRM Comment #96).
                 \120\ Id.
                ---------------------------------------------------------------------------
                 The Commission is aware of the issues raised by the AOA, but still
                believes that the high number of verifications is an indication that
                many consumers are not receiving their prescriptions from their
                prescribers. While a few new online sellers do not permit prescription
                presentation, these sellers' share of the overall contact lens sales is
                still quite small, even if their share of prescriber complaints,
                according to the AOA, is disproportionately large.\121\ Sellers with
                far greater sales, such as 1-800 CONTACTS and Walmart, actively
                encourage consumers to present their prescriptions, and 1-800 CONTACTS
                has even at times offered consumers discounts for doing so, because it
                is faster and less expensive than verification.\122\ Yet despite that
                encouragement, roughly 73% of overall sales by third-party sellers
                continues to occur via verification.\123\ Therefore, while the
                Commission will accord the high number of verifications less weight
                than it did in the NPRM, the Commission cannot dismiss its significance
                altogether as an indicator that consumers are not always provided their
                prescriptions, and will consider it as one of several factors in
                weighing the evidence of non-compliance in the record. The Commission
                also notes that even if the high number of verifications were
                disregarded altogether, the Commission's overall assessment of
                prescriber compliance, and the need for Rule modifications, would not
                change.
                ---------------------------------------------------------------------------
                 \121\ 1-800 CONTACTS accounts for approximately 10% of overall
                retail contact lens sales in the United States, and as much as 60-
                65% of online sales. The next closest online competitor has less
                than a quarter of the sales of 1-800 CONTACTS. See Fed. Trade
                Comm'n, The Contact Lens Rule and the Evolving Contact Lens
                Marketplace, Panel IV: Examining the Verification Process Tr. at 17
                (Mar. 7, 2018), https://www.ftc.gov/system/files/documents/public_events/1285493/panel_iv_examining_the_verification_process.pdf [hereinafter CLR
                Panel IV Tr.] (statement of Cindy Williams, 1-800 CONTACTS General
                Counsel). Walmart accounts for between 6-10% of all U.S. contact
                lens sales. Complaint Counsel's Post-Trial Brief and Exhibits, In
                the Matter of 1-800 CONTACTS, 5, (June 22, 2017), https://www.ftc.gov/system/files/documents/cases/d09372ccfindingsoffact.pdf;
                Respondent 1-800 CONTACTS Proposed Findings of Fact and Conclusions
                of Law, In the Matter of 1-800 CONTACTS, 59 (June 22, 2017), https://www.ftc.gov/system/files/documents/cases/d09372respfindingsoffact.pdf.
                 \122\ National Association of Optometrists and Opticians (SNPRM
                Comment #129) (``Because of the cost and time it takes to verify a
                prescription when the script is not available, typically an online
                seller encourages such uploading and this process aids in consumer
                satisfaction and quicker, more accurate service.''); 1-800 CONTACTS
                (SNPRM Comment #135) (1-800 CONTACTS encourages its customers to
                upload their prescriptions). See also CLR Panel IV Tr., supra note
                121, at 6-7 (statement of Jennifer Sommer of Walmart); id. at 6-7,
                22 (statement of Cindy Williams of 1-800 CONTACTS).
                 \123\ Paperwork Reduction Act Proposed Collection, Comment
                Request, 84 FR at 32171. See also 1-800 CONTACTS (NPRM Comment
                #3898) (stating that 70% of online orders require verification).
                ---------------------------------------------------------------------------
                2. Comments About the Need To Improve the Commission's Ability To
                Monitor Compliance and Enforce the Rule
                 Several commenters focused on the need to create an auditable
                record that would enable the Commission to monitor compliance and
                better enforce the automatic-release provision.\124\ One commenter, the
                Coalition for Contact Lens Consumer Choice, stated the Confirmation of
                Prescription Release proposal gives prescribers more leeway to design a
                system of confirmation of prescription release, but ``the important
                thing is that prescribers are still required to have patients
                affirmatively acknowledge release. . . . This is critical to increase
                enforcement of the law and to ensure that bad actors are identified
                quickly without inconveniencing those who are obeying the law.'' \125\
                The commenter Citizen Outreach agreed, stating that the only way to
                ensure compliance with automatic release is by requiring consumers to
                sign a confirmation, and suggested that failing to require a consumer's
                signed confirmation would be a loophole ``large enough for `bad actors'
                to drive a truckload of contact lenses through.'' \126\ Likewise, the
                Attorneys General of Twenty-Seven States commented that the proposed
                Confirmation of Prescription Release modifications ``strengthen the
                Commission's ability to verify compliance with the CLR [which] ensures
                more contact lens consumers have the necessary information to make
                informed decisions, spurring competition and consumer choice.'' \127\
                ---------------------------------------------------------------------------
                 \124\ Bosley (SNPRM Comment #58); Coalition for Contact Lens
                Consumer Choice (SNPRM Comment #89); National Hispanic Medical
                Association (SNPRM Comment #146).
                 \125\ Coalition for Contact Lens Consumer Choice (SNPRM Comment
                #89).
                 \126\ Citizen Outreach (SNPRM Comment #78).
                 \127\ Attorneys General of 27 States (SNPRM Comment #139).
                ---------------------------------------------------------------------------
                 Other commenters, however, felt that the FTC already has sufficient
                mechanisms to enforce the Contact Lens Rule, and should bring
                enforcement actions against so-called ``outliers'' who are violating
                the Rule, rather than imposing new requirements on all contact lens
                prescribers.\128\ Some suggested that the Confirmation of Prescription
                Release requirements should be imposed only on those found to be
                violating the prescription-release requirement.\129\ ``By refocusing
                these ideas as penalties, rather than mandates,'' according to AAO,
                ``the FTC can ensure that they are not inflicting burdens on
                prescribers that have a record of compliance with the prescription
                release requirement in the
                [[Page 50678]]
                CLR.'' \130\ AOA believes that the FTC already has sufficient authority
                and investigative tools at its disposal, and suggested the Commission
                could use its ability to issue administrative subpoenas to investigate
                prescribers who might be violating the Rule.\131\ One prescriber also
                commented that he was skeptical that prescribers who currently
                disregard the prescription-release requirement would comply with the
                confirmation requirement,\132\ a concern previously raised and
                discussed in the SNPRM.\133\
                ---------------------------------------------------------------------------
                 \128\ Mass Mail Campaign (SNPRM Comment #25); Ohio Optometric
                Association (SNPRM Comment #47); Hardy (SNPRM Comment #60) (``Is it
                a fair idea to punish 100% of optometrists and ophthalmologists for
                the actions of a fraction of 1%''); American Optometric Association
                (SNPRM Comment #96); American Academy of Ophthalmology (SNPRM
                Comment #136) (practices will have to comply with the new burdens
                even if they have complied with prescription-release for over a
                decade).
                 \129\ American Optometric Association (SNPRM Comment #96);
                American Academy of Ophthalmology (SNPRM Comment #136).
                 \130\ American Academy of Ophthalmology (SNPRM Comment #136).
                The AAO suggested that the acknowledgment and record-keeping
                provisions should be imposed on prescribers who have had multiple
                complaints, and whose non-compliance was verified after allowing
                prescribers an avenue to respond and defend themselves.
                 \131\ American Optometric Association (SNPRM Comment #96).
                 \132\ Steinemann (SNPRM Comment #138).
                 \133\ SNPRM, 84 FR at 24676, 24681.
                ---------------------------------------------------------------------------
                 Some commenters also criticized the FTC for, in their words, trying
                to acquire new authority to target small and mid-sized businesses, and
                stated this ran counter to the current trend for Congress and other
                federal agencies to ``recognize the need to alleviate the
                administrative burden that federal programs place on physician
                practices.'' \134\ And several commenters asserted that the Commission
                should not focus on enforcing requirements against prescribers while
                contact lens sellers, in their view, are violating Rule provisions in
                far greater numbers.\135\
                ---------------------------------------------------------------------------
                 \134\ American Society of Cataract and Refractive Surgery (SNPRM
                Comment #127). See also Letter from 20 U.S. Senators (SNPRM Comment
                #38); Letter from Sen. Lisa Murkowski (SNPRM Comment #49).
                 \135\ McManus (SNPRM Comment #18); Ulrich (SNPRM Comment #19)
                (FTC is punishing the wrong actors); Gilberg (SNPRM Comment #46);
                American Optometric Association (SNPRM Comment #96); American
                Academy of Ophthalmology (SNPRM Comment #136).
                ---------------------------------------------------------------------------
                 After considering these comments, the Commission continues to
                believe that some form of retained documentation is necessary to
                improve the Commission's enforcement and monitoring ability. As
                previously noted, the Commission currently faces challenges in
                enforcing the Rule. Prescribers, whether intentionally or not,
                currently can fail to release prescriptions yet risk little because
                consumers are unlikely to file a complaint if they ask for and
                subsequently receive a prescription. When a consumer does complain to
                the FTC, typically the only evidence is the word of the consumer
                against that of the prescriber, making it difficult for the Commission
                to establish with a degree of certainty whether a violation has
                occurred. This fact has played a significant role in the lack of Rule
                enforcement against prescribers over the last fifteen years, and may be
                a contributing factor to the high number of contact lens patients who
                do not currently receive their prescriptions automatically as required
                by law.
                 While the AOA suggests that the Commission can use its current
                authority to issue administrative subpoenas and conduct investigative
                hearings to explore possible Rule violations, an examination of a
                prescriber's Confirmation of Prescription Release records allows a much
                more efficient means of determining whether a prescriber is complying
                with the Rule, and is much less disruptive and burdensome for the
                prescriber.\136\
                ---------------------------------------------------------------------------
                 \136\ Serving administrative subpoenas on a wide-scale basis to
                prescribers who might not be releasing prescriptions, and requiring
                that a prescriber identify all of her contact lens customers for the
                last several months so they could be interviewed, would likely be
                criticized as excessive and heavy-handed.
                ---------------------------------------------------------------------------
                 As for the assertion that prescribers who do not currently comply
                with prescription release are unlikely to comply with the confirmation
                requirement, the difference is that in the latter instance, there would
                be a way to check compliance. If the Commission has concerns about a
                prescriber's compliance, it can request patient confirmations or proof
                of digital delivery, or a sample of such, which should resolve most
                questions as to whether the prescriber provided prescriptions in
                accordance with the law. In this way, it would benefit prescribers
                because they would have a relatively quick and inexpensive way to show
                the FTC they complied with their automatic-release obligations.
                 Further, the Commission is not attempting to expand its authority
                to target small businesses. The Commission already possesses the
                authority under the FCLCA to enforce the Rule for all contact lens
                prescribers, large and small. The Commission's Final Rule institutes a
                more effective mechanism for enforcing and evaluating the authority it
                already has. And while the Commission recognizes the need to avoid
                unnecessary government regulations, the Rule itself is, as one
                commenter put it, ``deregulatory'' in nature since its purpose is to
                restore free market competition, not to rein it in.\137\ If the Rule,
                as currently applied and enforced, is failing to meet this
                congressionally mandated goal in some respects, it is the duty of the
                Commission to find a more effective manner to realize that purpose.
                ---------------------------------------------------------------------------
                 \137\ National Taxpayers Union (SNPRM Comment #149).
                ---------------------------------------------------------------------------
                 With regard to the argument that it is unjust to focus on enforcing
                the automatic-release provision while not enforcing regulations that
                apply to sellers, the Commission does not agree with this premise. The
                Commission is aware of complaints about seller misconduct and is
                implementing several changes in this Final Rule to improve seller
                compliance. The Commission has also brought enforcement actions against
                sellers for violating the Rule and expects it will bring others in the
                future.\138\ Moreover, seller non-compliance does not excuse prescriber
                non-compliance, nor does it provide a justification for the Commission
                to reject taking action to improve compliance with a different
                requirement in the Rule.
                ---------------------------------------------------------------------------
                 \138\ See, e.g., U.S. v. Duskin, No. 1:18-cv-07359 (N.D. Cal.
                Dec. 6, 2018) (consent) U.S. v. Kim, No. 1:11-cv-05723 (E.D.N.Y. Feb
                7, 2012) (consent); U.S. v. Royal Tronics, Inc, No. 0:11-cv-62491
                (S.D. Fla. Jan. 27, 2012) (consent); U.S. v. Thy Xuan Ho, No. 1:11-
                cv-03419 (D. Minn. Dec. 27, 2011) (consent); U.S. v. Gothic Lens,
                LLC, No. 1:11-cv-00159 (N.D. Ga. Feb. 3, 2011) (consent); U.S. v.
                Jokeshop, LLC, No. 1:11-cv-11221 (D. Mass. Nov. 29, 2011) (consent);
                U.S. v. Contact Lens Heaven, Inc., No. 0:08-cv-61713 (S.D. Fla. Dec.
                3, 2008) (consent); U.S. v. Chapin N. Wright, II, No. 1:08-cv-11793
                (D. Mass. Oct. 31, 2008) (consent); U.S. v. BeWild, Inc., No. 2:07-
                cv-04896 (E.D.N.Y. Dec. 3, 2007) (consent); U.S. v. Pretty Eyes,
                LLC, No. 1:07-cv-02462 (D. Colo. Nov. 28, 2007) (consent); U.S. v.
                Walsh Optical, Inc., No. 2:06-cv-03591 (D.N.J. Aug. 30, 2006)
                (consent); see also FTC Sends Warning Letters to Sellers of Cosmetic
                Contacts: All Contact Lens Purchases Require a Prescription from a
                Medical Professional, https://www.ftc.gov/news-events/press-releases/2019/10/ftc-sends-warning-letters-sellers-cosmetic-contacts-all-contact; FTC Issues Warning Letters Regarding the
                Agency's Contact Lens Rule, https://www.ftc.gov/news-events/press-releases/2016/04/ftc-issues-warning-letters-regarding-agencys-contact-lens-rule.
                ---------------------------------------------------------------------------
                3. Comments About Whether the Structure of the Contact Lens Market
                Creates a Need for Verifiable Enforcement of Automatic Prescription
                Release
                 Many SNPRM commenters focused on the structure of the contact lens
                market and whether a system in which prescribers sell the items they
                prescribe creates an inherent conflict that requires additional
                corrective action by the Commission.\139\ U.S. Senator Ron Wyden, for
                example, commented that
                [[Page 50679]]
                Congress passed the FCLCA ``to address a distorted contact lens
                marketplace that had seen freedom of choice eroded as prescribers
                largely sold the contact lenses they prescribed,'' \140\ and another
                commenter wrote, ``The system here in the U.S. for buying contact
                lenses is stacked against consumers because the people who issue you
                your prescription are also allowed to sell you contact lenses at the
                very same time. Consumers who don't know their rights are getting
                `trapped in the exam chair' so to speak, unaware that they can buy
                lenses elsewhere for lower prices.'' \141\ According to the Information
                Technology & Innovation Foundation, which describes itself as a
                nonpartisan research and educational institute, ``the profession has
                both a powerful economic interest (profits) and a powerful tool (the
                prescription) to make it more difficult for consumers to buy their
                lenses from lower-cost providers.'' \142\ In fact, a number of
                commenters support the Commission's proposal because, while regulatory
                in nature, it is designed to promote free market competition and
                protect consumers' ability to purchase from the seller of their
                choice.\143\ One commenter wrote that the only solution to what she
                termed ``the inherent structural problem that continues to cause
                friction between providers and patients'' is to prohibit prescribers
                from selling contact lenses.\144\
                ---------------------------------------------------------------------------
                 \139\ Citizen Outreach (SNPRM Comment #78) (prescribers' ability
                to sell what they prescribe ensures a ``captive market''); Lens.com
                (SNPRM Comment #85) (``the current system is rigged against
                consumers and companies who compete with prescribers''); Coalition
                for Contact Lens Consumer Choice (SNPRM Comment #89); Taxpayers
                Protection Alliance (SNPRM Comment #118); Information Technology &
                Innovation Foundation (SNPRM Comment #103); National Hispanic
                Medical Association (SNPRM Comment #146).
                 \140\ Letter from Sen. Ron Wyden (SNPRM Comment #5); see also
                Taxpayers Protection Alliance (SNPRM Comment #118) (``Congress
                passed the bipartisan Fairness to Contact Lens Consumers Act to
                protect contact lens wearers. The result was less market distortion
                and more competition, leading to more choices and lower prices for
                consumers.'').
                 \141\ National Hispanic Medical Association (SNPRM Comment
                #146).
                 \142\ Information Technology & Innovation Foundation (SNPRM
                Comment #103).
                 \143\ See Americans for Tax Reform (SNPRM Comment #72) (``These
                changes strike the correct balance between promoting the free market
                and protecting important consumer rights.''); Citizen Outreach
                (SNPRM Comment #78); Taxpayers Protection Alliance (SNPRM Comment
                #118) (``Although we are often critical of government overreach and
                work hard to make government smaller, we believe that the FTC's
                proposed Contact Lens Rule is a government rule that works for
                taxpayers and consumers.''); National Taxpayers Union (SNPRM Comment
                #149) (``From the perspective of free-market, limited government
                advocates, the Contact Lens Rule has been one of the most balanced
                and successful examples of `deregulatory rulemaking' in the FTC's
                history.'').
                 \144\ Carafas (SNPRM Comment #39).
                ---------------------------------------------------------------------------
                 The AOA, on the other hand, disputes the premise that the contact
                lens market is unique, and argues that the fact that prescribers sell
                what they prescribe does not create an impetus for corrective
                regulation.\145\ According to the AOA, health care professionals in
                certain other areas--such as ambulatory surgery centers, orthopedic
                centers, and dental service providers, among others--also sell what
                they prescribe or recommend for treatment. Furthermore, according to
                the AOA, helping patients ``obtain treatment while in their doctor's
                office builds strong doctor-patient relationships and promotes patient-
                centered care.'' \146\ The AOA therefore concludes that ``the
                Commission seems to have used the inaccurate belief that contact lens
                prescribers' role in the market is entirely unique as a justification
                for implementing new regulations on physicians,'' and thus, ``the
                entire argument for supporting prescriber rule changes must be
                reevaluated.'' \147\
                ---------------------------------------------------------------------------
                 \145\ American Optometric Association (SNPRM Comment #96).
                 \146\ Id.
                 \147\ Id.
                ---------------------------------------------------------------------------
                 Several commenters also felt that the contact lens market is
                functioning properly, as evidenced by the relatively large number of
                contact lens sellers, and by lens prices that appear competitive, and
                thus there is no need for FTC intervention to modify the Rule.\148\ As
                support for this position, the AOA submitted a price-comparison
                analysis that it stated showed that the average price difference for
                contact lenses between online sellers and office prescribers was just
                thirty-two cents.\149\ According to the AOA, this demonstrates that the
                market is highly competitive, and thus the FCLCA and Rule are working
                as intended and, consequently, there is no need for Rule modification
                and a Confirmation of Prescription Release.\150\
                ---------------------------------------------------------------------------
                 \148\ Warner (SNPRM Comment #9); Ohio Optometric Association
                (SNPRM Comment #47); Cutter (SNPRM Comment #81); American Optometric
                Association (SNPRM Comment #96).
                 \149\ American Optometric Association (SNPRM Comment #96).
                 \150\ Id.
                ---------------------------------------------------------------------------
                 The Commission does not share this assessment. While there are now
                a number of different types of sellers, and the market has become more
                competitive than it was before the Rule,\151\ prescribers still possess
                a significantly higher share of contact lens sales than online sellers,
                mass merchandisers, or retail chains,\152\ even though prescriber
                prices, on the whole, are consistently higher.\153\ The AOA's
                assessment appears to be based on lens price per-packet, rather than
                per-day or per-year.\154\ The Commission does not believe per-packet
                pricing is a fair method of comparison, because it compares some lenses
                that are effectively sold in a multi-month supply with lenses that are
                only sold as a single month's supply. The Commission conducted a re-
                analysis of the AOA's data by aggregating to a consistent time-frame in
                order to compare what consumers might actually spend to wear lenses on
                a regular basis. This re-analysis--using the data supplied by AOA--
                determined that the average annual prices of contacts were from $9 to
                $40 more expensive if purchased from a private practice than from the
                leading online seller.\155\ The price difference for an annual supply
                of lenses was even starker between a private practitioner and a leading
                mass merchandiser, with private practitioners averaging between $62 and
                $92 more for an annual supply.\156\ Likewise, at the Commission's
                Contact Lens Workshop, an eye care consultant presented a price survey
                for sixteen leading contact lens brands and concluded that an annual
                supply of lenses purchased online
                [[Page 50680]]
                averaged $17.56 less than at an independent prescribers' office, and
                lenses purchased from a shopper's club averaged $42.44 less.\157\
                ---------------------------------------------------------------------------
                 \151\ CLR Panel I Tr., supra note 100, at 3-5 (remarks of Steve
                Kodey and accompanying slides, U.S. Optical Market Overview).
                 \152\ Approximately 39% of all contact lenses sales revenue in
                the U.S. occurs at independent eye care professionals, compared to
                18% at conventional chains, 25% at mass merchants and wholesale
                clubs, and 16% online. Vision Council, U.S. Optical Market Eyewear
                Overview 4 (2018), https://www.ftc.gov/sites/default/files/filefield_paths/steve_kodey_ppt_presentation.pdf. It is also worth
                noting that while the contact lens retail market has evolved since
                2004, it may well have changed less dramatically than many other
                retail industries have since the internet revolution began diverting
                sales from brick and mortar to online merchants.
                 \153\ See CLR Panel I Tr., supra note 100, at 9 (remarks of
                Wallace Lovejoy and accompanying slides, Contact Lens Price Ranges
                By Sales Channel); see also Opinion of the Commission, In the Matter
                of 1-800 CONTACTS, 4 (``Among brick-and-mortar retailers,
                independent ECPs typically have the highest prices for contact
                lenses . . . .''), https://www.ftc.gov/system/files/documents/cases/docket_no_9372_opinion_of_the_commission_redacted_public_version.pdf.
                 \154\ The Commission has not been able to precisely replicate
                the thirty-two-cent-difference figure stated by AOA. But by
                comparing average packet prices in the data supplied, the difference
                between private practices and online sellers is 35 cents. For the
                reasons stated, however, the Commission does not believe this figure
                is an appropriate comparison measure.
                 \155\ The average depends on whether a consumer purchased an
                annual supply all at once (in which case they received a discount
                from the online retailer) or in individual package increments. The
                Commission also notes that prices at the ``Leading Online
                Retailer,'' which, based on sales and market share, could be 1-800
                CONTACTS, might not represent the average online price for contact
                lenses, and prices at 1-800 CONTACTS, by its own admission, are
                typically higher than those of both other online sellers and retail
                club stores. Brief of 1-800 CONTACTS, 1-800 CONTACTS v. Federal
                Trade Commission (2d Cir. June 12, 2019); see also Opinion of the
                Commission, In the Matter of 1-800 CONTACTS, 4, https://www.ftc.gov/system/files/documents/cases/docket_no_9372_opinion_of_the_commission_redacted_public_version.pdf.
                 \156\ The data derives from the ABB Optical Group, Soft Lens
                Retail Price Monitor (First Quarter 2019).
                 \157\ CLR Panel I Tr., supra note 100, at 9 (remarks of Wallace
                Lovejoy and accompanying slides, Contact Lens Price Ranges By Sales
                Channel).
                ---------------------------------------------------------------------------
                 There can be valid reasons for differences in prices among sellers
                (some sellers may offer more convenience, options, or better customer
                service), and the Commission does not view price differences between
                private eye care practitioners and third-party sellers, in and of
                itself, as dispositive evidence that the market is not functioning in a
                competitive manner. But the Commission disagrees that the submitted
                pricing data is proof that the market is functioning in a perfectly
                competitive manner, and is proof that prescribers are providing
                patients with their prescriptions.
                 The Commission is also aware that there are other health care
                professionals who may sell what they prescribe or recommend for
                treatment, and has not based its proposal solely on a belief that
                contact lens prescribers' role and market is unique. Rather, the
                Commission has considered the structure of the market as a contributing
                factor in an overall evaluation of the need for improved Rule
                compliance and enforcement. It must be acknowledged--as it was by
                Congress when it enacted the FCLCA and directed the FTC to implement
                the Rule--that it is not in prescribers' self-interest for their
                patients to take prescriptions elsewhere to buy lenses.\158\ And while
                it is true that some health care professionals in other fields sell
                products that they prescribe or recommend for treatment, the sheer
                volume of contact lens prescribers' revenue and profit derived from the
                sale of contact lenses--16-32% of revenue, by some accounts \159\--
                creates a powerful incentive to keep those sales in house.
                ---------------------------------------------------------------------------
                 \158\ See H.R. Rep. No. 108-318, at 4-5 (stating that ``[t]he
                practice of optometrists withholding the prescription has limited
                the consumer's ability to shop for the best price and has impacted
                competition'' and that obstacles to free market competition are
                rooted in an ``inherent conflict of interest'' in that ``[u]nlike
                medical doctors who are prohibited from selling the drugs they
                prescribe, eye doctors and optometrists . . . are able to fill the
                contact lens prescriptions they write''); see also 149 Cong. Rec.
                H11564-65 (daily ed. Nov. 19, 2003) (statement of Rep. Stark) (``Eye
                doctors cite health concerns, but the fact is they have a strong
                financial incentive to restrict consumer access to the contact lens
                market.'').
                 \159\ Harris Williams & Co., Vision Industry Update, at 4 (Mar.
                2017); Harris Williams & Co., Vision Industry Overview, at 3 (Jan.
                2015). Contact Lens Spectrum has estimated the percentage of gross
                practice revenue from contact lenses to be 30%, and the net practice
                revenue at 26%, but the estimate does not specify how much of that
                was derived from sales of lenses versus professional fees for
                contact lens fittings and examinations. Contact Lens Spectrum, at 19
                (Jan. 2019), https://bt.editionsbyfry.com/publication/frame.php?i=552776&p=&pn=&ver=html5. See also Ken Kriviac, How to
                Hubble-Proof Your Contact Lens Practice, Review of Optometric
                Business (Jan. 17, 2018) (optometrist stating that 17% of his
                practice's total revenue is generated from the sale of contact lens
                related materials, with another 8% from related professional fees),
                https://reviewob.com/can-hubble-proof-contact-lens-practice/.
                ---------------------------------------------------------------------------
                4. Comments About the Text of the Proposed Confirmation of Prescription
                Release, and the Options To Include the Confirmation as Part of a
                Patient's Prescription or Sales Receipt
                 As noted previously, unlike the two-sentence signed-acknowledgment
                proposal from the NPRM,\160\ the SNPRM's Confirmation of Prescription
                Release proposal did not mandate specific text for the patient's signed
                confirmation. Instead, the SNPRM, for convenience, provided optional
                sample language that prescribers could use but left it up to individual
                prescribers to draft their own confirmation language if they so
                preferred.\161\ The Commission proposed this flexibility in response to
                commenter concerns that the language of the NPRM's signed-
                acknowledgment interfered with the prescriber-patient relationship by
                imparting the impression that prescribers had done something wrong. By
                permitting prescribers to draft their own confirmation language or use
                the provided, shortened sample language, the Commission aimed to allow
                prescribers to use wording that they believe would be less likely to
                reflect negatively on the prescribers' conduct.\162\ The Commission
                also proposed to allow prescribers to include the confirmation as part
                of a patient's prescription or sales receipt.\163\
                ---------------------------------------------------------------------------
                 \160\ NPRM, 81 FR at 88559.
                 \161\ SNPRM, 84 FR at 24683. The sample language provided by the
                Commission consisted of the following: ``My eye care professional
                provided me with a copy of my contact lens prescription at the
                completion of my contact lens fitting.''
                 \162\ Id.
                 \163\ Id.
                ---------------------------------------------------------------------------
                 One commenter, the National Association of Optometrists and
                Opticians (``NAOO''), praised the new options and flexibility, stating
                it would ``assist the industry in, and lighten the burdens of,
                compliance.'' \164\ The NAOO also approved of the FTC sample
                confirmation language, calling it a ``concise statement of the point of
                the Rule,'' and predicting it would be used by most of its
                members.\165\ The NAOO did suggest, however, that to avoid potential
                confusion from a confirmation statement containing additional
                acknowledgments or unnecessary information, the Rule should clarify
                that the patient's confirmation statement should not contain any
                message or acknowledgment other than that relating to confirmation of
                prescription release.\166\ The NAOO also suggested that in instances
                where a consumer refused to sign the confirmation, the Commission
                should allow the prescriber to note the refusal and the reason for it
                as evidence of compliance.\167\
                ---------------------------------------------------------------------------
                 \164\ National Association of Optometrists and Opticians (SNPRM
                Comment #129).
                 \165\ Id.
                 \166\ Id.
                 \167\ Id.
                ---------------------------------------------------------------------------
                 Other commenters felt that even with the new confirmation-language
                flexibility, requiring patients to confirm receipt of their
                prescriptions would imply that prescribers had been improperly
                withholding them.\168\ One prescriber commented, ``Why would I need to
                get a signature of my patient to confirm they received a prescription
                unless I was doing something wrong that required proof.'' \169\ Others
                felt that the requirement still unfairly forced them to aid their
                competition by reminding consumers that they could take their
                prescriptions to other sellers to have them filled.\170\
                ---------------------------------------------------------------------------
                 \168\ Abert (SNPRM Comment #20) (``The additional time required
                for this unneeded paperwork would disrupt the patient-doctor
                relationship by communicating to the patients that they should be
                wary of their physician, and assume that their doctor is a violator
                of Federal law.''); Ohio Optometric Association (SNPRM Comment #47)
                (``The proposal, even in its latest form, will . . . cast public
                doubt on the integrity of the optometrists and ophthalmologists . .
                . .''); Cutter (SNPRM Comment #81); Ritzel (SNPRM Comment #157)
                (``The idea of me having to have a patient sign a form certifying
                that I actually gave them a copy of their contact lens
                prescription--because ``Big Brother'' is watching--is insulting to
                myself as a person, and to my profession.'').
                 \169\ Cutter (SNPRM Comment #81).
                 \170\ Sanders (SNPRM Comment #61) (``It's akin to having Target
                have a big sign next to their own that states, `You can get
                everything here at Walmart as well!' ''); Poulter (SNPRM Comment
                #131) (``It is no more necessary for providers to inform patients of
                their right to purchase elsewhere than it is for a dentist to let a
                patient know he can purchase a crown from another party, then return
                to the dentist to have it placed.'').
                ---------------------------------------------------------------------------
                 In contrast, some commenters felt that allowing prescribers to
                draft their own language, and removing the second sentence of the
                acknowledgment (the requirement that patients confirm the statement:
                ``I understand I am free to purchase contact lenses from the seller of
                my choice''), greatly reduced the effectiveness of the new
                proposal.\171\ The online seller 1-800 CONTACTS, in particular,
                asserted that removal of the second sentence significantly reduced the
                educational benefit of the
                [[Page 50681]]
                requirement since consumers who were unaware they had a right to their
                prescription would not be so informed. 1-800 CONTACTS also stated that
                eliminating the second sentence made it less likely prescribers would
                release prescriptions directly after the fitting is complete, and
                prescribers would instead wait until patients had purchased lenses
                before giving them their prescriptions and obtaining Confirmations of
                Prescription Release.\172\ 1-800 CONTACTS also said there is no reason
                the second sentence would ``sow consumer doubt or harm prescribers'
                reputations'' unless the prescriber had previously been withholding
                prescriptions.\173\ The online seller therefore proposed that instead
                of leaving the wording up to prescribers, the confirmation requirement
                should again specify the wording required and include the second
                sentence from the acknowledgment proposal--albeit with a minor
                adjustment--so as to state, ``I understand that I am free to purchase
                contact lenses from my eye care professional or the seller of my
                choice.'' \174\ Inclusion of the option to purchase from the ``eye care
                professional'' might alleviate some concern that the notice was
                instructing consumers to buy from someone other than their prescriber.
                ---------------------------------------------------------------------------
                 \171\ Consumer Reports (SNPRM Comment #133); 1-800 CONTACTS
                (SNPRM Comment #135).
                 \172\ 1-800 CONTACTS (SNPRM Comment #135) (According to a survey
                conducted by an independent polling firm on behalf of 1-800
                CONTACTS, 38% of consumers who are given their prescription receive
                it at the same time or only after they have already purchased lenses
                from the prescriber).
                 \173\ Id. (``Because the Confirmation does not require that
                prescribers provide consumers with any notice of their rights, but
                merely requires that consumers acknowledge receipt by signature, it
                is far less likely to either educate consumers or discourage
                prescribers from pressuring consumers into buying lenses.'').
                 \174\ 1-800 CONTACTS (SNPRM Comment #135).
                ---------------------------------------------------------------------------
                 The consumer advocacy organization Consumer Reports also opposed
                permitting prescribers to devise their own language of confirmation,
                and opposed allowing prescribers to make the confirmation part of a
                prescription copy or sales receipt (Confirmation of Prescription
                Release options (B) and (C)).\175\ Instead, Consumer Reports stated
                that the confirmation should remain a stand-alone document, and
                suggested requiring the statement, ``My eye care professional provided
                me with a copy of my contact lens prescription at the completion of my
                contact lens fitting. I should give a copy of my prescription to the
                contact lens seller I choose.'' \176\ According to Consumers Reports,
                there are ``clear advantages to standardized wording,'' and by
                instructing consumers to present their prescription to sellers, this
                would further promote the Commission's goal of reducing
                verifications.\177\ Consumer Reports opined that a statement of
                confirmation added to the prescriber's copy of the prescription, or
                added to an examination receipt, might not be noticed by the
                patient.\178\
                ---------------------------------------------------------------------------
                 \175\ Consumer Reports (SNPRM Comment #133).
                 \176\ Id.
                 \177\ Id.
                 \178\ Id.
                ---------------------------------------------------------------------------
                 Some commenters also opined that when prescribers satisfy the
                confirmation by releasing the prescription electronically (option (D)),
                prescribers should still provide consumers with a statement advising
                them that they have a right to their prescription and have the option
                to buy lenses elsewhere.\179\ And many commenters raised concerns about
                whether to allow option (D) altogether, as discussed in more detail
                below.
                ---------------------------------------------------------------------------
                 \179\ Id.; 1-800 CONTACTS (SNPRM Comment #135).
                ---------------------------------------------------------------------------
                 With respect to allowing options (B) and (C), and permitting
                prescribers to craft their own wording, the Commission acknowledges
                that the confirmation proposal may provide less of an immediate
                educational benefit than the NPRM's proposed Signed Acknowledgment. By
                permitting prescribers to include the confirmation on the prescription
                itself, or on a sales receipt, it is indeed possible that some
                consumers will fail to understand its purpose, or what it is they are
                signing. And by not requiring that the confirmation include a sentence
                specifically informing consumers of their right to have prescriptions
                filled elsewhere, and not requiring a notice to this effect with
                digital delivery, some consumers may remain unaware of prescription
                portability.
                 The Commission, however, continues to believe that the benefit from
                providing prescribers with greater flexibility, reducing the possible
                paperwork burden, and limiting potential interference with the
                prescriber-patient relationship, justifies the trade-off. As noted in
                the SNPRM, the Confirmation of Prescription Release will maintain much
                of the effectiveness and enforceability of the Signed Acknowledgment,
                while reducing the impact on prescribers.\180\
                ---------------------------------------------------------------------------
                 \180\ SNPRM, 84 FR at 24683.
                ---------------------------------------------------------------------------
                 The Commission also does not believe that requiring patients to
                sign a confirmation will provoke doubts about the integrity of their
                prescribers. While patients might draw the conclusion that some
                prescribers have not always automatically released prescriptions, there
                is little reason for patients to conclude that their individual
                prescriber had failed to do so, especially if their prescriber has
                always provided them with their prescription. It seems more likely that
                patients may simply conclude that the law has changed. Furthermore, as
                noted in the SNPRM, consumers are accustomed to signing acknowledgments
                or receipts. Many pharmacists require patients to acknowledge that they
                do not have questions upon receiving a prescription; physicians'
                offices require visitors to sign in; and patients are accustomed to
                signing HIPAA acknowledgment forms signifying they received a
                provider's Notice of Privacy Practices.\181\ The Commission is not
                aware of any evidence that such requirements sow distrust on the part
                of the person signing the receipt. The Commission believes this will
                hold true for the Confirmation of Prescription Release, particularly
                since prescribers can devise their own language of confirmation. The
                Commission also believes that while it may be advisable for providers
                to avoid potential patient confusion by not including any other
                acknowledgments or information on the confirmation document, it is not
                necessary to expressly prohibit this in the Rule at this time. Such a
                prohibition might limit the flexibility of the new proposal, and could
                make it more difficult for providers to avail themselves of options (B)
                and (C) by including patient confirmation as part of a sales receipt or
                prescription copy. Moreover, as noted in the SNPRM, while prescribers
                are free to provide their own language, it would remain a violation for
                the receipt to include additional information proscribed by the Rule,
                such as liability waivers or agreements to purchase lenses from the
                prescriber.\182\
                ---------------------------------------------------------------------------
                 \181\ Id. at 24682.
                 \182\ Id. at 24683.
                ---------------------------------------------------------------------------
                5. Comments About Option (D) and Using Electronic Delivery for
                Confirmation of Prescription Release
                 In the SNPRM, the Commission proposed modifying the Rule to allow
                prescribers to satisfy the automatic prescription release requirement
                by providing a digital copy in lieu of a paper copy when the patient
                gives verifiable affirmative consent.\183\ The Commission noted that
                using online patient portals and other electronic methods to complete
                the automatic prescription release offered potential benefits for
                sellers, prescribers, and patients.\184\ Patients would be able to
                [[Page 50682]]
                access their prescriptions and have electronic copies to send to
                sellers. With the prescription, a seller would no longer need to submit
                a verification request, which would benefit prescribers by reducing the
                volume of requests. However, there were also some concerns about
                portals, including that patients may not be aware of the portal or have
                difficulty accessing it.\185\ Because the Commission did not have
                sufficient information to determine whether solely posting a contact
                lens prescription on a patient portal would be sufficient to satisfy
                the Rule's obligation for prescribers to provide a copy of the
                prescription after completing the contact lens fitting, the Commission
                sought comments on its proposed Rule modification.\186\ The Commission
                also asked for comments on whether prescribers should be required to
                maintain any records documenting a patient's verifiable consent to
                receive a prescription electronically.\187\
                ---------------------------------------------------------------------------
                 \183\ Id. at 24669.
                 \184\ Id. at 24668.
                 \185\ Id.
                 \186\ Id. at 24669.
                 \187\ Id. at 24690.
                ---------------------------------------------------------------------------
                a. Use of Patient Portals and Patient Consent
                 Many commenters expressed support for allowing prescribers to use
                electronic methods, such as a patient portal, to provide prescriptions
                to patients who consent.\188\ Among the potential benefits, commenters
                noted the reduction in verification calls or requests for additional
                copies, easier access to and use of a prescription, lower costs, and
                flexibility for patients and prescribers.\189\ Currently, many
                prescribers already use a portal or other electronic methods to
                communicate with and, in some instances, provide prescriptions to their
                patients,\190\ and use of electronic methods is expected to increase in
                the future.\191\ For example, one survey found that approximately 64.2%
                of eye care professionals communicated with patients by text message,
                of which 26.4% used it to respond to personal questions about the
                patient's eye health.\192\ Because a significant percentage of eye care
                providers already use electronic communications and portals, the
                Commission believes that the required, automatic prescription release
                could be completed effectively through a digital copy when a patient
                provides verifiable affirmative consent. Verifiable affirmative consent
                means that a patient must have provided his or her consent to the
                prescriber in a way that can be later confirmed. A signed consent form,
                an email from the patient to the prescriber, or an audio recording from
                a telephone conversation with a patient would be examples of verifiable
                affirmative consent. Notification through, for example, a posted office
                sign or a general written notice of office policies or practices would
                not constitute affirmative consent because patients have not indicated
                to the prescriber whether or not they consent.
                ---------------------------------------------------------------------------
                 \188\ See, e.g., Liao (SNPRM Comment #2); Coalition for Contact
                Lens Consumer Choice (SNPRM Comment #89); Consumer Action (SNPRM
                Comment #101); Information Technology & Innovation Foundation (SNPRM
                Comment #103); Alcon Vision, LLC (SNPRM Comment #117); National
                Association of Optometrists and Opticians (SNPRM Comment #129);
                CooperVision, Inc. (SNPRM Comment #130) (noting that electronic
                delivery of a prescription is ``a common-sense, low burden method of
                giving patients better access to their prescriptions''); 1-800
                CONTACTS (SNPRM Comment #135); Attorneys General of 27 States (SNPRM
                Comment #139); National Hispanic Medical Association (SNPRM Comment
                #146); Backus (WS Comment #1650).
                 \189\ Americans for Tax Reform (SNPRM Comment #72); Coalition
                for Contact Lens Consumer Choice (SNPRM Comment #89); Consumer
                Action (SNPRM Comment #101); Information Technology & Innovation
                Foundation (SNPRM Comment #103); National Association of
                Optometrists and Opticians (SNPRM Comment #129); CooperVision, Inc.
                (SNPRM Comment #130); Consumer Reports (SNPRM Comment #133).
                 \190\ See, e.g., Coalition for Contact Lens Consumer Choice
                (SNPRM Comment #89); American Optometric Association (SNPRM Comment
                #96); National Association of Optometrists and Opticians (SNPRM
                Comment #129) (stating that practice management systems and
                electronic health records are easily available at reasonable
                prices); Sikes (SNPRM Comment #114); Klepfisz (SNPRM Comment #140);
                Eklund (WS Comment #502); Holland (WS Comment #513); Reed (WS
                Comment #749); Gitchell (WS Comment #759); Andrews (WS Comment
                #1014); Carvell (WS Comment #1021); Cecil (WS Comment #1892); Kuryan
                (WS Comment #3472); Hopkins (NPRM Comment #184); Wilson (NPRM
                Comment #1310); Grove (NPRM Comment #1702); MacDonald (NPRM Comment
                #2118); Andrus (NPRM Comment #3345).
                 \191\ FTC, The Contact Lens Rule and the Evolving Contact Lens
                Marketplace, Panel V: Prescription Release & Consumer Choice Tr. at
                18-21 (Mar. 7, 2018), https://www.ftc.gov/system/files/documents/public_events/1285493/panel_v_prescription_release_and_consumer_choice.pdf [hereinafter
                CLR Panel V Tr.].
                 \192\ Jobson Research, ECP Digital Solutions Study (2019) (also
                finding that of those surveyed, approximately 74.4% contacted their
                patients by email, of which 45.5% used it to respond to personal
                questions about the patient's eye health). As noted in the SNPRM,
                another survey showed that approximately 30% of patients were
                offered access to a portal during their last eye exam and that 29%
                chose to use the portal. SNPRM, 84 FR at 24668 n.50.
                ---------------------------------------------------------------------------
                 Several commenters supported the use of electronic methods, but had
                a variety of concerns or proposed changes. Some thought patients might
                prefer a paper copy instead of an electronic copy of their
                prescription, including people who are older, reluctant to use
                technology or worried about online privacy or identity theft, unable to
                navigate a cumbersome portal, without internet or smartphone access, or
                not proficient in English.\193\ The Commission shares these concerns
                and the Final Rule thus maintains the ability for patients who prefer a
                paper copy for any reason to obtain such a copy. Even if a prescriber
                offers electronic delivery, a patient could decline to provide consent.
                Likewise, prescribers who are concerned about the security or costs of
                electronic methods can continue providing paper copies.\194\ The Final
                Rule neither compels prescribers to offer prescription release by an
                electronic method nor requires that patients accept their prescription
                by electronic method when offered by the prescriber.
                ---------------------------------------------------------------------------
                 \193\ R Street (SNPRM Comment #15); Americans for Tax Reform
                (SNPRM Comment #72); Coalition for Contact Lens Consumer Choice
                (SNPRM Comment #89); American Optometric Association (SNPRM Comment
                #96); National Hispanic Medical Association (SNPRM Comment #146);
                National Taxpayers Union (SNPRM Comment #149).
                 \194\ American Optometric Association (SNPRM Comment #96);
                American Society of Cataract and Refractive Surgery (SNPRM Comment
                #127).
                ---------------------------------------------------------------------------
                 One seller urged the Commission to require that the prescribers,
                when seeking affirmative consent, identify to patients the specific
                method of electronic delivery that would be used.\195\ The Commission
                believes that requiring prescribers to identify the specific method or
                methods \196\ would allow patients to make a more informed decision and
                increase awareness of how the prescription would be provided if they
                were to consent. It is also possible that a patient prefers one method
                of electronic communication, but not others.\197\ Therefore, the
                Commission is amending the definition of ``Provide to the patient a
                copy'' to require that prescribers who choose to offer an electronic
                method, identify the specific method or methods to be used and, if a
                patient consents, have evidence of verifiable affirmative consent to
                the identified method or methods.
                ---------------------------------------------------------------------------
                 \195\ 1-800 CONTACTS (SNPRM Comment #135).
                 \196\ A request for consent that states that the prescription
                would be delivered electronically, but does not state the method,
                such as email, text, or portal, would not be adequate. If more than
                one method is offered, prescribers must specifically identify each
                one.
                 \197\ 1-800 CONTACTS (SNPRM Comment #135).
                ---------------------------------------------------------------------------
                 Regarding patient portals specifically, some commenters expressed
                concerns that: (1) Patients would be unaware that their prescription is
                on a portal; (2) there could be a delay in posting prescriptions to the
                portal; or (3) prescribers might intentionally make portals difficult
                to use, post prescriptions without telling their patients, or confuse
                patients into thinking that they must buy lenses from
                [[Page 50683]]
                them.\198\ They urged the Commission to require that prescribers notify
                patients when a prescription is available on the portal, provide
                instructions on how to access the portal, or confirm that the
                prescription has been received.\199\ The Commission believes that the
                Final Rule provides adequate safeguards for patients who have opted to
                receive their prescription on a portal. As noted in the SNPRM, the use
                of a portal or other electronic method does not change the timing of
                when a prescriber must provide a copy of the contact lens
                prescription.\200\ A prescriber must provide the prescription
                immediately after the completion of the contact lens fitting, or in the
                case of a renewal, when a prescriber determines that no change to the
                existing prescription is required.\201\ Furthermore, prescribers can
                only use a portal to satisfy their obligation under Sec. 315.3(a)(1)
                when they have affirmative consent to the specific method or methods of
                electronic delivery. Therefore, patients should be aware that their
                prescription will be provided electronically using the method to which
                they consented. The Rule also requires that patients be able to access,
                download, and print the prescriptions from the portal.\202\ If patients
                were to have any problems with using the portal, they could revoke
                their consent and request a paper copy.\203\ Notwithstanding these
                safeguards, the Commission encourages prescribers to provide
                instructions to patients who may encounter difficulties accessing their
                portal. The Commission believes that the Rule, with the modification to
                require that prescribers identify the specific electronic method to be
                used, balances the interests of prescribers and patients by offering a
                flexible method that could reduce the burden on prescribers and allow
                patients greater access to their prescriptions.\204\
                ---------------------------------------------------------------------------
                 \198\ R Street (SNPRM Comment #15); Lens.com (SNPRM Comment
                #85); Coalition for Contact Lens Consumer Choice (SNPRM Comment
                #89); Consumer Action (SNPRM Comment #101); Information Technology &
                Innovation Foundation (SNPRM Comment #103); 1-800 CONTACTS (SNPRM
                Comment #135); National Hispanic Medical Association (SNPRM Comment
                #146); Senator Mike Lee (SNPRM Comment #159).
                 \199\ R Street (SNPRM Comment #15); Information Technology &
                Innovation Foundation (SNPRM Comment #103); Consumer Reports (SNPRM
                Comment #133); 1-800 CONTACTS (SNPRM Comment #135); Senator Mike Lee
                (SNPRM Comment #159).
                 \200\ SNPRM, 84 FR at 24669 n.54.
                 \201\ Id.
                 \202\ The Commission does not have any evidence that prescribers
                are intentionally making portals difficult for their patients to
                use. However, such conduct, if it were to occur, could violate the
                Rule because patients would not be able to access their
                prescription.
                 \203\ Patients could also request an additional copy under 16
                CFR 315.3(a)(3).
                 \204\ Consumer Action appears to encourage the Commission to
                provide further guidance on portal design in the Rule. SNPRM Comment
                #101. Given the potential for future developments in technology and
                the differences among prescribers' practices and current software,
                the Commission declines to mandate requirements on portal design.
                See CLR Panel V Tr., supra note 191, at 18-21 (discussing the
                variety of electronic-health-records programs available from
                ``hundreds'' of ECH vendors, with each program based on different
                standards and providing varying degrees of functionality and
                compatibility).
                ---------------------------------------------------------------------------
                 Furthermore, some commenters want a paper copy to be provided in
                addition to the electronic copy,\205\ but the Commission declines to
                adopt this suggestion because requiring both copies would undercut a
                benefit of using electronic methods and be unnecessary for patients who
                have expressed a preference for an electronic copy. Finally, a
                commenter states that telemedicine prescribers should not be required
                to provide paper prescriptions.\206\ Although patients who opt for
                telemedicine might be more comfortable with technology and receiving
                health care online,\207\ some patients may still prefer their
                prescription on paper. Since telemedicine providers should have been
                providing a paper copy under the current Rule, continuation of this
                practice, when a patient does not consent to electronic delivery,
                should not be impractical or overly burdensome.
                ---------------------------------------------------------------------------
                 \205\ Americans for Tax Reform (SNPRM Comment #72); Lens.com
                (SNPRM Comment #85); Coalition for Contact Lens Consumer Choice
                (SNPRM Comment #89); Consumer Action (SNPRM Comment #101); Consumer
                Reports (SNPRM Comment #133).
                 \206\ Simple Contacts (SNPRM Comment #87).
                 \207\ Id.
                ---------------------------------------------------------------------------
                b. Requirement To Maintain Records of Patient Consent
                 In the SNPRM, the Commission proposed requiring that prescribers
                obtain affirmative consent in order to provide a prescription
                electronically, but did not require that prescribers maintain evidence
                of consent. In response, several commenters have urged the Commission
                to require that prescribers maintain records pertaining to patients'
                affirmative consent.\208\ According to some of these commenters, a
                record of consent would allow more effective compliance monitoring,
                while the burden of storing such a record would be minimal.\209\ By
                contrast, the AOA states that prescribers should not be required to
                maintain records of consent because the AOA believes it would be
                burdensome \210\ and ``provides no obvious benefit to the patient''
                since ``the likelihood of harm from a patient receiving a contact lens
                prescription electronically is low to nonexistent.'' \211\ However,
                other commenters countered that there is a potential for harm since
                patients who do not consent might not realize that they received their
                prescription electronically, or might be unable to access it.\212\
                ---------------------------------------------------------------------------
                 \208\ Consumer Action (SNPRM Comment #101); Information
                Technology & Innovation Foundation (SNPRM Comment #103); National
                Association of Optometrists and Opticians (SNPRM Comment #129);
                Consumer Reports (SNPRM Comment #133); 1-800 CONTACTS (SNPRM Comment
                #135).
                 \209\ Consumer Action (SNPRM Comment #101) (stating that the
                cost of storing digital records is not burdensome); Information
                Technology & Innovation Foundation (SNPRM Comment #103) (stating
                that the cost of storing a consent form would be virtually zero).
                 \210\ See also American Society of Cataract and Refractive
                Surgery (SNPRM Comment #127) (discussing the administrative burden
                related to maintaining records of consent). Other commenters contend
                that the burden of storing these records would be minimal.
                Information Technology & Innovation Foundation (SNPRM Comment #103).
                 \211\ American Optometric Association (SNPRM Comment #96). The
                AOA also asserts that ``[p]atients do not have to consent to the
                electronic delivery of other prescriptions.'' However, there may be
                differences between contact lens prescriptions and some other types
                of medical prescriptions. In many instances, other types of
                prescriptions being delivered electronically are not being sent to a
                patient, but rather to a pharmacy that then fills the prescription.
                When a prescription is sent to a pharmacy, the patient would likely
                have selected or have knowledge of the receiving pharmacy. In 2013,
                57% of prescriptions nationally were sent electronically from
                physicians to pharmacies, with the rate in some states over 80%.
                U.S. Dep't of Health & Human Servs., The Office of the National
                Coordinator for Health Information Technology, ``E-Prescribing
                Trends in the United States'' 8 (2014) (stating also that 96% of all
                community pharmacies in the U.S. accept e-prescriptions).
                 \212\ R Street (SNPRM Comment #15); Coalition for Contact Lens
                Consumer Choice (SNPRM Comment #89); Consumer Action (SNPRM Comment
                #101); National Hispanic Medical Association (SNPRM Comment #146);
                National Taxpayers Union (SNPRM Comment #149).
                ---------------------------------------------------------------------------
                 The Commission finds persuasive the arguments in favor of requiring
                a record of patient consent to electronic delivery. The burden of
                retaining a record of patient consent should be minimal, since
                prescribers who opt for electronic delivery of prescriptions will, in
                all likelihood, obtain and/or store such consent electronically. Even
                if they do not, it should not take any longer to obtain and store
                patient consent to electronic delivery than it would to obtain and
                store a patient's Confirmation of Prescription Release via options (A),
                (B) or (C). Furthermore, a prescriber is not required to offer patients
                a digital prescription. Rather, it is at his or her option. Moreover,
                consent to receipt of a digital copy would aid in enforcing the Rule
                since,
                [[Page 50684]]
                without a record of consent, there would be no way for the Commission
                to confirm that patients who were given their prescriptions
                electronically agreed to such electronic delivery, and had the ability
                to access their prescriptions in this manner. The Final Rule will thus
                require that prescribers keep records or evidence of a patient's
                affirmative consent to a digital copy for at least three years.
                Although some commenters have sought longer retention periods,\213\
                three years is a time period consistent with other recordkeeping
                obligations in the Rule.
                ---------------------------------------------------------------------------
                 \213\ Information Technology & Innovation Foundation (SNPRM
                Comment #103) (requesting five years); 1-800 CONTACTS (SNPRM Comment
                #135) (requesting that the record be kept as long as the affirmative
                consent is active). State laws could require that prescribers
                maintain these records for longer than three years.
                ---------------------------------------------------------------------------
                6. Comments About Alternatives to the Confirmation of Prescription
                Release
                 In addition to the suggestions--discussed previously--that the
                Commission increase its enforcement of the current Rule, or impose new
                requirements only as a penalty for specific providers found in non-
                compliance,\214\ some commenters proposed alternative means of ensuring
                that consumers receive their prescriptions.
                ---------------------------------------------------------------------------
                 \214\ American Optometric Association (SNPRM Comment #96).
                ---------------------------------------------------------------------------
                a. Signage
                 Several commenters reiterated the idea--raised and discussed in
                some detail in the SNPRM \215\--that instead of requiring a patient
                acknowledgment or confirmation, the Commission ought simply to require
                that prescribers post signs informing consumers of their right to their
                prescriptions.\216\ In its SNPRM, the Commission acknowledged that
                signage offers some of the benefits of a patient confirmation, but
                concluded that it had significant drawbacks: In the particular
                environment of a prescriber's office, far fewer consumers would learn
                of their rights from a sign than from being asked to sign a receipt;
                signage would serve as less of a reminder to prescribers and their
                staff to release prescriptions; signage would do nothing to aid the
                Commission in monitoring and enforcing the prescription-release
                requirement; and relying on patients to notice a sign and ask for their
                prescriptions put the onus on consumers to enforce the Rule, and would
                effectively amend the FCLCA's automatic-release provision to release-
                upon-request, a statutory revision only Congress can make.\217\ The
                Commission also noted that relying on consumers to ask for their
                prescriptions is problematic since consumers might not see the sign, or
                might be uncomfortable asking their prescribers for their
                prescriptions.\218\ Based on those reasons, the Commission declined to
                propose signage as an alternative to a Confirmation of Prescription
                Release.\219\
                ---------------------------------------------------------------------------
                 \215\ SNPRM, 84 FR at 24679.
                 \216\ Letter from 20 U.S. Senators (SNPRM Comment #38); Letter
                from Sen. Lisa Murkowski (SNPRM Comment #49); Cutter (SNPRM Comment
                #81); American Optometric Association (SNPRM Comment #96); Gilbert
                (SNPRM Comment #119); Patel (SNPRM Comment #123); Letter from N.D.
                State Sen. Judy Lee (SNPRM Comment #161).
                 \217\ SNPRM, 84 FR at 24682-83.
                 \218\ Id. at 24682.
                 \219\ Id. at 24682-83.
                ---------------------------------------------------------------------------
                 Some SNPRM commenters agreed with the Commission's position,
                stating that ``requiring prescribers to post signs doesn't work,''
                \220\ and asserting that in California, where a state law requires
                contact lens prescribers to post signs detailing patient rights, some
                optometrists fail to comply, or post the signs in locations consumers
                are unlikely to see them.\221\ In contrast, other commenters contended
                that the Commission should reconsider the signage alternative,
                reiterating that it would be less burdensome and intrusive for
                prescribers and could address the FTC's educational objectives without
                costly regulation.\222\ The AOA also took issue with the fact that the
                Commission cited HHS's implementation of a signed-acknowledgment for a
                prescriber's HIPAA obligation instead of opting for signage.\223\
                According to the AOA, anything HHS concluded when it constructed the
                HIPAA signed-acknowledgment is no longer relevant since HHS is now
                considering eliminating the requirement and switching to signage in
                order to reduce the burden on health care practitioners.\224\
                Furthermore, according to the AOA, ``the physician community is united
                in its belief'' that the HIPAA signed-acknowledgment should be
                eliminated, and this shows that such acknowledgment requirements
                constitute poor policy, and signage is a better option.\225\
                ---------------------------------------------------------------------------
                 \220\ Coalition for Contact Lens Consumer Choice (SNPRM Comment
                #89); Consumer Action (SNPRM Comment #101).
                 \221\ Americans for Tax Reform (SNPRM Comment #72). As noted in
                the SNPRM, the Commission does not have empirical data about
                prescriber compliance with the state signage requirement, 16 CCR
                1566, which has been in effect in California since 1994. However, an
                analysis of consumer survey evidence provided by Survey Sampling
                International indicates that regardless of signage, Californians do
                not automatically receive their prescriptions in substantially
                greater numbers than residents of states without a signage
                requirement. SNPRM, 84 FR at 24679.
                 \222\ Kochik (SNPRM Comment #8) (stating that the real issue is
                that patients are unaware of the law, and so the solution is
                signage); Letter from 20 U.S. Senators (SNPRM Comment #38); Letter
                from Sen. Lisa Murkowski (SNPRM Comment #49).
                 \223\ American Optometric Association (SNPRM Comment #96). The
                obligation in question is the HIPAA requirement that health care
                providers provide patients with a Notice of Privacy Practices
                (``NPP'') and obtain a patient's signature acknowledging receipt of
                same. Notice of Privacy Practices for Protected Health Information,
                14 CFR 164.520(c)(2)(ii).
                 \224\ American Optometric Association (SNPRM Comment #96)
                (quoting Request for Information on Modifying HIPAA Rules to Improve
                Coordinated Care, 83 FR 64302, 64302-03 (2018), https://www.govinfo.gov/content/pkg/FR-2018-12-14/pdf/2018-27162.pdf#page=1.)
                 \225\ American Optometric Association (SNPRM Comment #96). It is
                worth noting that a review of the comments submitted in response to
                the recent HHS proposal to eliminate HIPAA's signed-acknowledgment
                requirement reveals that while many health care providers do
                consider it an unnecessary use of staff time and resources, other
                health care providers support the acknowledgment requirement, and
                several noted that the burden of obtaining a patient's signed
                acknowledgment is relatively minimal. See, e.g., Jackson Health
                System (Comment in Response to Request For Information, Office for
                Civil Rights, Department of Health and Human Services [hereinafter
                ``HHS RFI Comment''] #467) (does not support modifying the
                requirement because signed NPP acknowledgment forms are ``useful''
                to prove that the NPP was provided to the patient); Dr. Mitchell
                Strauss (HHS RFI Comment #851) (``The signature is the only way of
                confirming for posterity that the NPP was discussed. If this step is
                no longer required, it will be far too easy for practices to stop
                making the effort for acknowledgement of the NPP.''); Multnomah and
                Clackmas Counties (HHS RFI Comment #926) (foresees adverse
                consequences--potential complaints and misunderstandings--if signed
                acknowledgment requirement is removed); San Francisco Department of
                Public Health (HHS RFI Comment #1241) (``Having a written record
                assures patients and covered entities that patients are informed
                about privacy practices.''); American College of Osteopathic Family
                Physicians (HHS RFI Comment #1262) (strongly believes that there
                must be some level of accountability and responsibility for ensuring
                patients understand their privacy rights); Massachusetts Department
                of Mental Health (HHS RFI Comment #1003) (``The burden is
                negligible.''); Missouri Hospital Association (HHS RFI Comment
                #1175) (``MHA's members do not find the requirement cumbersome.'');
                Cigna (HHS RFI Comment #1132) (``Obtaining acknowledgment of receipt
                is not an operational burden [and] the burden to maintain document
                of acknowledgment or declination is minimal.''). HHS RFI Comments
                are available at https://www.regulations.gov/docketBrowser?rpp=25&po=0&D=HHS-OCR-2018-0028.
                ---------------------------------------------------------------------------
                 While it is true that HHS is presently evaluating whether to
                eliminate the HIPAA Notice of Privacy Practices signed-acknowledgment
                requirement, the Commission's Confirmation of Prescription Release
                proposal, and the decision not to allow signage as an alternative, does
                not rely on the HIPAA signed-acknowledgment requirement as precedent.
                In the SNPRM, the Commission merely referenced aspects of HIPAA's
                signed-acknowledgment requirement and HHS's evaluation of the
                regulatory burden as informative when considering whether to require
                some form of patient confirmation of
                [[Page 50685]]
                prescription release.\226\ Any other reliance on the HIPAA signed-
                acknowledgment requirement is generally inappropriate since that
                signed-acknowledgment requirement differs from the Commission's
                confirmation proposal in important respects. The primary intent of the
                HIPAA signed-acknowledgment was to provide patients an opportunity to
                review the provider's Notice of Privacy Practices, discuss concerns
                related to their private health information, and request additional
                confidentiality.\227\ It was not to remedy a lack of compliance by
                doctors with HIPAA requirements. Unlike this Rule review, the HHS
                record does not contain empirical evidence showing that doctors are not
                fulfilling their obligations to provide Notices of Privacy Practices to
                patients, and only a handful of commenters to HHS's recent Request for
                Information even suggested that this could occur should the HIPAA
                signed acknowledgment be removed.\228\ This contrasts sharply with the
                circumstances of the Commission's proposed Confirmation of Prescription
                Release, which is intended to remedy a documented compliance gap
                resulting, at least to some extent, from inherent incentives that may
                discourage prescribers from providing patients with their
                prescriptions.
                ---------------------------------------------------------------------------
                 \226\ SNPRM, 84 FR at 24682.
                 \227\ Request for Information on Modifying HIPAA Rules to
                Improve Coordinated Care, Office for Civil Rights, Department of
                Health and Human Services, 83 FR at 64308.
                 \228\ See generally Comments in Response to Request for
                Information on Modifying HIPAA Rules to Improve Coordinated Care,
                Office for Civil Rights, Department of Health and Human Services,
                https://www.regulations.gov/docketBrowser?rpp=25&po=0&D=HHS-OCR-2018-0028.
                ---------------------------------------------------------------------------
                 The Commission continues to believe that for purposes of automatic
                prescription release, signage would be significantly less effective
                than the proposed Confirmation of Prescription Release. None of the
                comments to the SNPRM presented any data or evidence that would counter
                the Commission's prior conclusion. The AOA's argument that the HIPAA
                signed-acknowledgment experience should not be looked to as a model
                does not alter the Commission's determination that there is a
                compelling need for a verifiable method of ensuring that contact lens
                patients receive their prescriptions.
                b. Educational Programs as an Alternative to Confirmation of
                Prescription Release
                 Some commenters opined that instead of having consumers confirm
                that they received their prescription, the best manner to inform
                consumers about their prescription rights was through an educational
                program.\229\ According to one contact lens manufacturer, the FTC and
                sellers should continue to ``communicate to patients through social
                media, websites, advertising, and other channels so that patients
                become even more aware that they can leave their final fitting with a
                copy of their right prescription.'' \230\ Others suggested that the
                Commission could partner with the Centers for Disease Control and the
                Food and Drug Administration (``FDA'') to produce public service
                announcements informing patients of their rights.\231\ Another
                commenter suggested that instead of a signed confirmation, patients'
                rights to their prescriptions could be ``spelled out in the entry forms
                a patient signs when they check in.'' \232\ Similarly, the AOA
                suggested that a ``patient bill of rights for contact lens wearers''
                could be provided to patients that would include FDA information on
                considerations for buying lenses.\233\ One commenter, the NAOO, said
                that even with a Confirmation of Prescription Release, the Commission
                should focus on educating the public about its rights to automatic
                release of a prescription.\234\
                ---------------------------------------------------------------------------
                 \229\ Abert (SNPRM Comment #20); Tran (SNPRM Comment #94);
                CooperVision, Inc. (SNPRM Comment #130).
                 \230\ CooperVision, Inc. (SNPRM Comment #130).
                 \231\ American Optometric Association (SNPRM Comment #96); Tran
                (SNPRM Comment #94).
                 \232\ Cutter (SNPRM Comment #81).
                 \233\ American Optometric Association (SNPRM Comment #96).
                 \234\ National Association of Optometrists and Opticians (SNPRM
                Comment #129).
                ---------------------------------------------------------------------------
                 The Commission agrees that educating the public can aid in
                increasing the likelihood that contact lens users will receive their
                prescriptions after a fitting.\235\ Consumer education in itself,
                however, whether provided via information entry forms, a patients' bill
                of rights, advertising, or public service announcements, would not have
                a significant impact on prescriber compliance with automatic
                prescription release, and would not increase the Commission's ability
                to monitor and enforce the Rule. The proposed education alternatives
                would also place a burden on consumers to enforce their own rights, an
                approach the Commission has rejected repeatedly in the past when
                considering whether to amend the Contact Lens Rule and Eyeglass Rule to
                release-upon-request.\236\ Therefore, while the Commission believes
                education about the Rule and its automatic-prescription-release
                provision is important, the Commission does not believe education
                should be the sole means of improving Rule compliance.
                ---------------------------------------------------------------------------
                 \235\ The Commission educates consumers on their rights under
                the Contact Lens Rule through a variety of sources, including blog
                posts, Facebook, Twitter, and on the FTC's website. See, e.g.,
                https://www.consumer.ftc.gov/articles/0116-prescription-glasses-and-contact-lenses.
                 \236\ See Eyeglass I, 43 FR at 23998 (stating that relying upon
                release-upon-request is problematic because many consumers are
                unaware of their right to a prescription, and because the right
                should be ``immunized from an evidentiary squabble over whether the
                consumer actually did or did not request the prescription''); Final
                Trade Regulation Rule, Ophthalmic Practice Rules 54 FR 10285, 10286-
                87 (Mar. 13, 1989) [hereinafter Eyeglass II] (rejecting a proposal
                to change the Rule to release-upon-request and finding a
                ``continuing need'' for automatic release). See also Contact Lens
                Rule, 69 FR at 40492 (discussing a commenter proposal to allow
                prescribers to not release the prescription or release it for
                ``informational purposes only'' if the patient has purchased a full
                year's supply of contact lenses at the time of the examination, and
                rejecting it because ``such an exception would be contrary to the
                Act's express requirement that consumers receive a copy of their
                prescription at the completion of a contact lens fitting'').
                ---------------------------------------------------------------------------
                7. Comments About the Burden and Benefits of the Confirmation of
                Prescription Release Proposal
                 Many commenters stated that even with the proposed modifications to
                increase flexibility, the Confirmation of Prescription Release
                requirement is still overly burdensome for prescribers.\237\ According
                to commenters, eye care practitioners are already overburdened by
                regulatory requirements, and the confirmation requirement would divert
                resources from patient care, increase health care costs, and might even
                drive some prescribers to cease prescribing contact lenses or close
                their practices.\238\ More specifically, the AAO stated that many of
                the options for obtaining patient confirmation would require practices
                to change procedures and alter administrative forms.\239\ Others noted
                [[Page 50686]]
                that the requirement to dispense paper copies of the confirmation to
                patients runs counter to the trend towards electronic records,
                particularly for those who have already invested in an electronic
                recordkeeping system.\240\ One commenter opined that patients ought to
                bear more responsibility for their own health care.\241\ Others noted
                that the proposal was ``going against the tide'' by adding a new
                regulation at a time when some government agencies are looking to
                reduce regulations.\242\
                ---------------------------------------------------------------------------
                 \237\ Warner (SNPRM Comment #9); Mass Mail Campaign (SNPRM
                Comment #25) (saying the requirement imposed ``massive new costs and
                far-reaching new requirements on all contact lens prescribing'');
                Yokum (SNPRM Comment #53); Staup (SNPRM Comment #104); American
                Society of Cataract and Refractive Surgery (SNPRM Comment #127);
                Letter from Sen. Lisa Murkowski (SNPRM Comment #49).
                 \238\ Goldstein (SNPRM Comment #14) (``The economic burdens of
                administrative compliance with these new regulations would except in
                rare cases encourage me not to fit or prescribe contact lenses.'');
                Pierce (SNPRM Comment #17) (will ultimately lead to higher health
                care costs, might have to raise fees); Mass Mail Campaign (SNPRM
                Comment #25); Shum (SNPRM Comment #80) (``Adding more paperwork and
                scanning work--and making it required on everyone--doesn't sound
                like it would be a big deal, but to a small practice it's huge.'');
                Cinalli (SNPRM Comment #93) (new regulation will close many
                practices); Klepfisz (SNPRM Comment #140) (burden has the potential
                to put some prescribers out of business).
                 \239\ American Academy of Ophthalmology (SNPRM Comment #136).
                 \240\ Lowe (SNPRM Comment #40); Reeder (SNPRM Comment #55)
                (signature upon receipt of prescription is ``burdensome and counter
                to other initiatives to reduce paper held by offices''); Boyer
                (SNPRM Comment #59) (``We try very hard to reduce paper waste . . .
                . [This] will undo our efficiency and distract our staff from our
                daily caseload, resulting in increased costs and reduced care.'').
                 \241\ Steiner (SNPRM Comment #7).
                 \242\ American Optometric Association (SNPRM Comment #96);
                American Society of Cataract and Refractive Surgery (SNPRM Comment
                #127).
                ---------------------------------------------------------------------------
                 Some commenters believed the Commission was underestimating the
                burden to obtain confirmations and preserve the records, and provided
                their own estimates, including that it would cost $10,000 per
                year,\243\ or would require 10 minutes per patient for a total of ``850
                man-hours per year,'' \244\ the equivalent of about 21 additional weeks
                of work. The AOA, which had previously estimated the cost of the
                signed-acknowledgment requirement to be as high as $18,795 per
                optometrist,\245\ did not submit a new burden estimate for the
                Confirmation of Prescription Release proposal, but reiterated its
                belief that the Rule's burden falls disproportionately on prescribers,
                and expressed concern that the estimated financial burden for the Rule
                in the 2019 SNPRM is higher than the financial burden estimate cited
                for the NPRM's signed-acknowledgment proposal.\246\ Some commenters
                also stated that the use of option (D), electronic delivery, would not
                significantly reduce their burden, since it would require them to
                update their systems or invest in expensive technology.\247\ According
                to the AOA, many prescribers would not be able to opt for electronic
                delivery because of limitations in electronic health records systems,
                privacy and data-security concerns, and state regulations that might
                not permit prescription posting to portals.\248\
                ---------------------------------------------------------------------------
                 \243\ Pierce (SNPRM Comment #17).
                 \244\ Steinemann (SNPRM Comment #65).
                 \245\ American Optometric Association (NPRM Comment #3830). This
                estimate was cited again by some commenters to the SNPRM. Koerber
                (SNPRM Comment #41); American Society of Cataract and Refractive
                Surgery (SNPRM Comment #127). In the SNPRM, the Commission explained
                that it could not accord this estimate significant weight because it
                was based not on the cost of the Commission's proposed Signed
                Acknowledgment but on the overall cost of government regulations
                (including those already in place), and because the survey had
                various methodological limitations. SNPRM, 84 FR at 24677.
                 \246\ American Optometric Association (SNPRM Comment #96).
                 \247\ American Society of Cataract and Refractive Surgery (SNPRM
                Comment #127).
                 \248\ American Optometric Association (SNPRM Comment #96).
                ---------------------------------------------------------------------------
                 Other commenters disputed that the burden would be significant, and
                stated that the confirmation requirement would not add significant
                costs or time.\249\ According to the Information Technology &
                Innovation Foundation, prescriber claims that the proposal would
                require significant additional staff training are overstated.\250\
                Another commenter, a prescriber, stated, ``In our office, we already
                have patients sign a contact lens agreement before the contact lens
                evaluation process. I don't see a problem adding a document at the end
                of the process and having the patient sign an acknowledgment of rx
                receipt.'' \251\ One commenter contended that while there would be some
                burden on eye care providers, it represented just a ``tiny fraction''
                of the industry's overall revenue, and would be far outweighed by the
                benefits.\252\ Others asserted that allowing prescribers to provide
                patients with digital copies would save both prescribers and patients
                time and money.\253\ Some commenters suggested that the Commission was
                actually over-estimating the burden imposed by the confirmation
                requirement.\254\ 1-800 CONTACTS, for example, submitted a new analysis
                from Stanford University Professor Laurence Baker, which called the
                assumptions used in the Commission's burden analysis very
                ``conservative,'' and estimated that a reduction in verifications by
                just 15% would be sufficient to offset all of the costs of the
                confirmation requirement.\255\ The NAOO also felt the burden would be
                ``minimal,'' and opined that with more patients in possession of their
                prescriptions, there would be fewer orders relying on the verification
                process, and thus fewer verifications for prescribers to have to take
                the time to respond to.\256\ NAOO also opined that with more
                practitioners moving to practice management systems and electronic
                health records, digital delivery of contact lens prescriptions is a
                ``very feasible'' option for many prescribers, which would reduce the
                burden of the confirmation requirement.\257\
                ---------------------------------------------------------------------------
                 \249\ Tobias (SNPRM Comment #45); Rawson (SNPRM Comment #68);
                (Citizen Outreach (SNPRM Comment #78); Consumer Action (SNPRM
                Comment #101); Information Technology and Innovation Foundation
                (SNPRM Comment #103); National Association of Optometrists and
                Opticians (SNPRM Comment #129); Consumer Reports (SNPRM Comment
                #133).
                 \250\ Information Technology and Innovation Foundation (SNPRM
                Comment #103) (``A few minutes of instruction, coupled with reading
                a one- or two-page memo should more than suffice.'').
                 \251\ Gilberg (SNPRM Comment #46).
                 \252\ Taxpayer Protection Alliance (SNPRM Comment #118) (overall
                burden of the new requirement would be minimal and outweighed by the
                substantial benefit of having significantly more patients in
                possession of their prescription).
                 \253\ Grimm (SNPRM Comment #36) (proposal to allow new methods
                for providing prescriptions will help relieve paperwork burden);
                Coalition for Contact Lens Consumer Choice (SNPRM Comment #78); Liao
                (SNPRM Comment #2) (portal proposal will make automatic release more
                efficient).
                 \254\ National Taxpayers Union (SNPRM Comment #149); 1-800
                CONTACTS (SNPRM Comment #135, Ex. A).
                 \255\ 1-800 CONTACTS (SNPRM Comment #135).
                 \256\ National Association of Optometrists and Opticians (SNPRM
                Comment #129).
                 \257\ Id.
                ---------------------------------------------------------------------------
                 Some commenters also felt that the Commission should not give much
                weight to burden concerns raised by prescribers due to their history of
                not complying with their prescription-release obligations.\258\ The
                National Hispanic Medical Association, for example, stated that the
                focus on the burden for prescribers was ``upsetting when one remembers
                just how many patients are being robbed of their right to lower prices
                and more convenient shipping and being denied a copy of something that
                they worked hard to pay for, namely, their own prescription.'' \259\
                ---------------------------------------------------------------------------
                 \258\ Information Technology & Innovation Foundation (SNPRM
                Comment #103); 1-800 CONTACTS (SNPRM Comment #135); National
                Hispanic Medical Association (SNPRM Comment #146).
                 \259\ National Hispanic Medical Association (SNPRM Comment
                #146).
                ---------------------------------------------------------------------------
                 The Commission has considered the burden the Confirmation of
                Prescription Release requirement would place on prescribers. As stated
                in the SNPRM, the evidentiary record does not establish that the burden
                will be substantial.\260\ Nothing received or revealed since the SNPRM
                alters that assessment. In fact, numerous health care providers--
                commenting on their experience with HIPAA--said that the burden of
                requiring that a patient sign a confirmation-type receipt is
                ``minimal,'' \261\ ``negligible,'' \262\ or ``not significant.'' \263\
                And while AOA is
                [[Page 50687]]
                correct that the SNPRM's estimated financial burden for the
                Confirmation of Prescription Release was higher than that estimated for
                the Signed Acknowledgment, that was primarily due to an increase in the
                average hourly wages for prescribers and staff.\264\ In terms of time
                required for prescribers and their staff to comply, the SNPRM burden
                from the confirmation proposal was 13% less than that of the NPRM's
                signed-acknowledgment proposal.\265\ The estimated burden of this
                modified Final Rule is also higher than the Signed Acknowledgment
                proposal, but a large part of the increase is due to higher wages and a
                substantial rise in the number of estimated contact lens wearers since
                publication of the NPRM.\266\ Furthermore, while the Final Rule's
                estimated financial burden for the Confirmation of Prescription Release
                requirement of $20,428,750, is not insignificant, it amounts to
                approximately just $342 in increased administrative costs per eye care
                provider.\267\ In addition, while not every prescriber will be able to
                use option (D) to deliver a prescription electronically, the Commission
                is confident that this option will still reduce the burden for many,
                especially as more prescribers move toward electronic recordkeeping.
                ---------------------------------------------------------------------------
                 \260\ SNPRM, 84 FR at 24681.
                 \261\ Multnomah and Clackamas Counties (HHS RFI Comment #926);
                Cigna (HHS RFI Comment #1132).
                 \262\ Massachusetts Department of Mental Health (HHS RFI Comment
                #1003).
                 \263\ San Francisco Department of Public Health (HHS RFI Comment
                #1238). See also Jackson Health System (HHS RFI Comment #467) (``The
                acknowledgment procedure takes less than one minute.''); UnityPoint
                Health (HHS RFI Comment #1122) (costs are relatively low, average of
                60 seconds to explain NPP and obtain patient's signature); UC Health
                (HHS RFI Comment #1155) (time spent to explain and obtain each
                signed acknowledgment is 40 seconds per patient); Missouri Hospital
                Association (HHS RFI Comment #1175); American Alliance of
                Orthopaedic Executives (HHS RFI Comment #1183). Other commenters to
                the HHS proposal disagreed, stating that the NPP signed
                acknowledgment requirement was an unnecessary burden, although much
                of their criticism was directed at the NPP itself rather than the
                acknowledgment. See, e.g., American Physical Therapy Association
                (HHS RFI Comment #601) (``Providers currently undertake reasonable
                efforts to obtain the patient's signature, and in most instances the
                patients ignore the language when signing the document.''); Highmark
                Health (HHS RFI Comment #1124) (``The effort to comply with this
                requirement is disproportionately onerous vis-[agrave]-vis the
                general lack of attention individuals afford the NPP.'').
                 \264\ SNPRM, 84 FR at 24693-94.
                 \265\ SNPRM, 84 FR at 24693-94.
                 \266\ See Section XI, infra.
                 \267\ This is based on an estimate from Wallace Lovejoy, a
                consultant for the National Association of Optometrists and
                Opticians, that there are approximately 43,000 optometrists and
                16,700 ophthalmologists in the U.S. CLR Panel I Tr., supra note 100,
                at 6. Estimates vary as to the total number of eye care providers
                and contact lens prescribers in the United States, making it
                difficult to precisely calculate the burden on a per-provider or
                per-prescriber basis. The investment firm Harris Williams & Co., for
                instance, put the estimate at 46,000 optometrists and 18,000
                ophthalmologists. Harris Williams & Co., Vision Industry Update, at
                2 (Mar. 2017) https://www.harriswilliams.com/system/files/industry_update/vision_industry_update_hcls_0.pdf. Meanwhile, the
                U.S. Bureau of Labor Statistics estimates there are 42,100
                optometrists in the U.S., but does not provide an estimate for the
                number of ophthalmologists. https://www.bls.gov/ooh/healthcare/optometrists.htm#tab-1. It must be noted, however, that not all
                optometrists and ophthalmologists prescribe contact lenses.
                ---------------------------------------------------------------------------
                8. Comments About the Exemption for Prescribers Who Do Not Have a
                Direct or Indirect Financial Interest in the Sale of Contact Lenses
                 In the SNPRM, the Commission proposed an exemption from the
                Confirmation of Prescription Release requirement for prescribers who do
                not have a direct or indirect financial interest in the sale of contact
                lenses, including, but not limited to, though an association,
                affiliation, or co-location with a contact lens seller.\268\ The
                purpose of the proposed exemption was to reduce the burden on
                prescribers who do not sell lenses, and therefore, have no incentive to
                withhold prescriptions. The failure of the prescriber to provide the
                prescription under such circumstances would provide no benefit to the
                prescriber while likely alienating the patient. In fact, there is a
                strong incentive to provide patients with their prescriptions, since
                that is the only way they would be able to obtain contact lenses.
                ---------------------------------------------------------------------------
                 \268\ SNPRM, 84 FR at 24698.
                ---------------------------------------------------------------------------
                 At least one commenter voiced support for the exemption,\269\ but
                some were critical of the proposal.\270\ Some commenters suggested
                removing it in order to ``future proof'' the prescription-release
                process in light of new and evolving business models--and intermingled
                financial interests--between prescribers and contact lens sellers.\271\
                According to one commenter, the exception for those without a financial
                interest is ``intentionally vague and leaves the barn door open for
                interpretation and abuse.'' \272\ The AOA also objected to the
                underlying premise that prescribers might consider their own interests
                above those of their patients.\273\
                ---------------------------------------------------------------------------
                 \269\ Consumer Reports (SNPRM Comment #133) (``Although getting
                and keeping a record of the patient confirmation will not pose any
                significant burden, by definition these prescribers would seem not
                to pose any risk of conflict of interest in releasing the
                prescription; indeed, they would have an inherent interest in
                releasing it.'').
                 \270\ Contact Lens Institute (SNPRM Comment #79); Zerbinopoulos
                (SNPRM Comment #147); Johnson & Johnson Vision Care, Inc. (SNPRM
                Comment #151).
                 \271\ See Contact Lens Institute (SNPRM Comment #79); Johnson &
                Johnson Vision Care, Inc. (SNPRM Comment #151); Alcon (SNPRM Comment
                #117).
                 \272\ Zerbinopoulos (SNPRM Comment #147).
                 \273\ American Optometric Association (SNPRM Comment #96).
                ---------------------------------------------------------------------------
                 The Commission recognizes these concerns, but believes there is a
                significant benefit in more narrowly targeting only those with an
                incentive to withhold prescriptions, thereby further reducing the
                overall burden and avoiding unnecessarily impacting prescribers who are
                unlikely to violate the Rule. Moreover, the Commission believes that
                determination of whether a financial interest exists is feasible, and
                that prescribers are unlikely to arrange their financial interests and
                business structures solely to circumvent the Confirmation of
                Prescription Release requirement. The Commission also believes it has
                the investigative tools to examine whether there is a financial
                interest, should the need arise. And if the Commission determines upon
                later review that such financial manipulation is occurring to
                circumvent the Rule, the Commission can revisit whether to remove the
                exemption.
                D. Additional Discussion and Commission Determination Regarding the
                Confirmation of Prescription Release Proposal
                 The Commission has carefully reviewed and analyzed the entire
                record developed with respect to the Confirmation of Prescription
                Release proposal. This record includes more than 8,000 comments
                submitted in response to its 2015 Request for Comment, 2016 NPRM, 2018
                Contact Lens Workshop, and 2019 SNPRM, as well the original history and
                legislative record relating to enactment of the FCLCA and the Rule in
                2004.
                 The evidentiary record as set forth in the NPRM and the SNPRM, as
                well as the Commission's enforcement and oversight experience, supports
                the view that compliance with the Rule's automatic-prescription-release
                requirement is sub-optimal, and as a result, a substantial number of
                consumers--several million contact lens users every year--are not
                receiving their contact lens prescriptions as required by law. Many
                consumers are unaware they even have a right to receive them.
                Implementing a Confirmation of Prescription Release requirement will
                result in an increase in the number of patients in possession of their
                prescriptions; improved flexibility and choice for consumers; a reduced
                verification burden for prescribers and sellers; a reduced likelihood
                of medical errors associated with incorrect, invalid, and expired
                prescriptions; and a reduction in the number of attempts to verify with
                the wrong prescriber.\274\ The ultimate result will be improved
                competition in the market, more efficient contact lens sales, improved
                patient safety, and lower prices for consumers. Furthermore, the
                [[Page 50688]]
                requirement will increase the Commission's ability to enforce and
                assess its Rule, and will accomplish this in a reasonable manner that
                takes into consideration the needs and burdens of prescribers and
                sellers.
                ---------------------------------------------------------------------------
                 \274\ SNPRM, 84 FR at 24681.
                ---------------------------------------------------------------------------
                 In response to commenters' concerns, the Commission has made three
                modifications to the proposal put forth in the SNPRM. The Commission
                concurs with the suggestion that requiring prescribers to identify the
                specific method or methods they would use for electronic delivery of
                prescriptions will increase awareness and allow patients to make a more
                informed decision. The Commission will therefore define ``Provide to
                the patient a copy'' in the Final Rule to require that prescribers who
                choose to offer an electronic method of delivery identify the specific
                method or methods used. The Commission also believes that evidence of
                consumer consent to electronic delivery of a prescription will aid in
                enforcing the Rule, and thus in its Final Rule, the Commission is
                requiring that prescribers keep records or evidence of a patient's
                affirmative consent to a digital copy for at least three years. Lastly,
                for instances where a consumer refuses to sign the confirmation, in the
                Final Rule, the Commission directs the prescriber to note the refusal
                and preserve this record as evidence of compliance. The Commission
                believes that the burden from these three changes will be minimal.
                III. Additional Requirements for Sellers Using Verification Calls
                Containing Automated Messages
                 In response to the Commission's NPRM, a number of commenters
                criticized the use of verification calls containing automated messages
                (``automated telephone messages''), which they often refer to as
                ``robocalls,'' \275\ with some requesting an outright ban of these
                calls.\276\ The Act and the Rule dictate that sellers that do not have
                a contact lens prescription presented to them directly or by facsimile
                verify the prescription by ``direct communication.'' \277\ That term,
                in the Act and Rule, is defined as ``completed communication by
                telephone, facsimile, or electronic mail.'' \278\ The Commission has
                stated that the Act expressly permits telephone communication for
                verification and believes that it would be contrary to congressional
                intent to prohibit use of automated telephone calls for the purpose of
                prescription verification.\279\
                ---------------------------------------------------------------------------
                 \275\ See SNPRM, 16 FR at 24684 and n.270.
                 \276\ See SNPRM, 16 FR at 24685 and n.281.
                 \277\ 15 U.S.C. 7603(a); 16 CFR 315.5(a)(2).
                 \278\ Specifically, the Act defines direct communication to
                ``include'' a completed communication via one of these three
                methods, 15 U.S.C. 7603(g), whereas the Rule defines ``direct
                communication'' to ``mean'' a completed communication via one of
                these three methods, 16 CFR 315.2, a distinction discussed below.
                 \279\ SNPRM, 16 FR at 24684.
                ---------------------------------------------------------------------------
                 In response to the SNPRM, commenters continued to express criticism
                of automated telephone messages \280\ with some continuing to urge the
                Commission to ban them.\281\ The AOA indicated that issues surrounding
                automated telephone messages have increased in the past five years and
                that poor quality automated telephone messages are jeopardizing eye
                health and resulting in consumers wearing non-prescribed contact
                lenses. It reports an increase in the use of calls that are difficult
                to understand, do not include all of the necessary information to
                confirm the prescription, and create barriers for prescribers to
                communicate corrections.\282\ Johnson & Johnson Vision Care and
                individual prescribers believe that automated telephone messages can
                ultimately lead to patients receiving incorrect lenses and suffering
                adverse health outcomes.\283\
                ---------------------------------------------------------------------------
                 \280\ Gilberg (SNPRM Comment #46); Armitage (SNPRM Comment #66);
                Contact Lens Institute (SNPRM Comment #79); American Optometric
                Association (SNPRM Comment #96); Health Care Alliance for Patient
                Safety (SNPRM Comment #128); CooperVision, Inc. (SNPRM Comment
                #130); Johnson & Johnson Vision Care, Inc. (SNPRM Comment #151).
                 \281\ Gilberg (SNPRM Comment #46); Armitage (SNPRM Comment #66);
                Contact Lens Institute (SNPRM Comment #79); Health Care Alliance for
                Patient Safety (SNPRM Comment #128); CooperVision, Inc. (SNPRM
                Comment #130); Johnson & Johnson Vision Care, Inc. (SNPRM Comment
                #151).
                 \282\ American Optometric Association (SNPRM Comment #96).
                 \283\ Reeder (SNPRM Comment #55) (automated calls and passive
                verification can result in approval for patients who have never been
                seen and can lead to injury); Armitage (SNPRM Comment #66) (no way
                to safely and accurately ensure that a patient's prescription is
                correctly verified with a robocall-based system); Johnson & Johnson
                Vision Care, Inc. (SNPRM Comment #151). See also Alcon Vision, LLC
                (SNPRM Comment #117) (noting health and safety risks associated with
                robocalls).
                ---------------------------------------------------------------------------
                 Other commenters, however, indicated that automated telephone
                messages were not problematic and should not be prohibited.\284\
                Consumer Action stated that ``automated call systems appear to be
                working in a majority of cases'' and that prescribers should design
                more responsive systems for handling such requests.\285\ The NAOO
                commented that from its members' perspective, there are ``no issues
                with the use of automated calls, which tend to be infrequent to any
                particular prescriber's office'' and that such calls are an efficient
                method of verification.\286\
                ---------------------------------------------------------------------------
                 \284\ Consumer Action (SNPRM Comment #101); National Association
                of Optometrists and Opticians (SNPRM Comment #129).
                 \285\ Consumer Action (SNPRM Comment #101).
                 \286\ National Association of Optometrists and Opticians (SNPRM
                Comment #129); see also 1-800 CONTACTS (SNPRM Comment #135) (its
                records indicate that ``on average, prescribers are asked to verify
                just one order from 1-800 a week'').
                ---------------------------------------------------------------------------
                A. The Congressional Record Does Not Support Prohibiting Automated
                Telephone Messages
                 Commenters in favor of a ban on such calls argue that the
                Commission lacks evidence that Congress intended to include automated
                calls in the definition of ``direct communication'' \287\ and should
                eliminate the use of this antiquated technology in favor of methods
                that provide written documentation and the possibility of greater
                oversight in the verification process.\288\ In support of a ban,
                commenters stated that the Act does not mention the use of automated
                telephone messages and that the Commission's interpretation of such
                calls as a valid form of ``direct communication'' may be counter to
                testimony provided during hearings that occurred prior to the Act's
                implementation.\289\ These commenters stated that ``congressional
                members and the then CEO of a major online contact lens seller made
                statements critical of automated telephone verification, stating
                explicitly that fax or another verifiable method were the preferred
                prescription verification methods for contact lens prescriptions.''
                \290\
                ---------------------------------------------------------------------------
                 \287\ Health Care Alliance for Patient Safety (SNPRM Comment
                #128); CooperVision, Inc. (SNPRM Comment #130); Johnson & Johnson
                Vision Care, Inc. (SNPRM Comment #151).
                 \288\ Health Care Alliance for Patient Safety (SNPRM Comment
                #128); CooperVision, Inc. (SNPRM Comment #130); Johnson & Johnson
                Vision Care, Inc. (SNPRM Comment #151). CLR Panel IV Tr., supra note
                121, at 9 (request of Steinemann for written requests only and not
                ``robocalls'').
                 \289\ Health Care Alliance for Patient Safety (SNPRM Comment
                #128); Johnson & Johnson Vision Care, Inc. (SNPRM Comment #151).
                 \290\ Health Care Alliance for Patient Safety (SNPRM Comment
                #128); Johnson & Johnson Vision Care, Inc. (SNPRM Comment #151).
                ---------------------------------------------------------------------------
                 A closer analysis of the congressional testimony reveals a question
                to the CEO of the contact lens seller about earlier testimony by the
                AOA mentioning problems with both automated calls and continuous
                faxes.\291\ The CEO's
                [[Page 50689]]
                response merely recognized that there had been criticism of automated
                calls, and stated that at that time the company preferred fax
                verifications because they were written.\292\ There is no other mention
                of issues with automated calls by congressional members or the CEO
                during that hearing.\293\ Instead, such testimony arguably shows that
                Congress had been made aware of the criticisms of automated calls and,
                if it had wished to do so, could have banned their use explicitly. Yet,
                Congress specifically included telephone as a valid form of direct
                communication. The hearing also evidences a recognition that telephone
                communications, unlike faxes, would not be written. As a result,
                reference to this testimony does not change the Commission's view that
                automated telephone messages are a permissible form of direct
                communication.
                ---------------------------------------------------------------------------
                 \291\ See ``Fairness to Contact Lens Consumers Act: Hearing
                Before the Subcommittee on Commerce, Trade, and Consumer Protection
                of the House Committee on Energy and Commerce,'' 108th Cong. 1
                (Sept. 12, 2003) (Rep. Shimkus: ``Mr. Coon [CEO of 1-800 CONTACTS],
                there have been some questions [raised in earlier hearing testimony
                from the AOA] about the techniques companies like yours use to
                verify orders for contact lens prescriptions, and problems such as
                automated calls and continuous faxes inhibiting optometrists from
                verifying prescriptions. Could you just go through your procedures
                for me?'').
                 \292\ Id. (In response to Rep. Shimkus's request to go through
                the company's procedures, Rep. Burr: Mr. Coon, how does 1-800
                currently request doctor verification? Mr. Coon: Well, the best
                system that we have found works the best, which we do in a majority
                of our orders--and there has been criticism of phone automated
                systems and other things. The system that works the best is in
                writing by fax. We know that there is a confirmation that it was
                received. And that's the system that we would recommend.'').
                 \293\ The Commission is also unaware of any other on-the-record
                discussions about automated calls during congressional consideration
                of the FCLCA.
                ---------------------------------------------------------------------------
                 The Health Care Alliance for Patient Safety referred to automated
                telephone messages as antiquated technology,\294\ and stated that the
                Commission should ban such calls in favor of methods that provide
                verifiable written communication, including fax, emails, and electronic
                portals.\295\ Such documentation, according to the Alliance, will allow
                for greater oversight and a safer environment allowing prescription
                verification through clearer, more concise and accurate communication
                between the prescriber and the seller.\296\ As previously stated,
                Congress expressly permitted use of the telephone knowing that this
                method did not produce writings like the other delineated verification
                methods, facsimile and email, and thus, the Commission declines to
                prohibit the use of this medium for verification.
                ---------------------------------------------------------------------------
                 \294\ Health Care Alliance for Patient Safety (SNPRM Comment
                #128).
                 \295\ Health Care Alliance for Patient Safety (SNPRM Comment
                #128); CooperVision, Inc. (SNPRM Comment #130). The Commission
                declines to include portals as a method by which sellers can verify
                prescriptions. In considering the proposal, the Commission
                considered that the Act defines direct communication to include
                telephone, fax, or email. As stated in the 2004 SBP, Congress's use
                of the term ``includes'' contemplates that additional methods of
                communication could develop that could be used in the verification
                process. 69 FR 40490. However, there is no evidence that prescribers
                and sellers are using, or are likely to use, portals in the
                verification process.
                 \296\ Health Care Alliance for Patient Safety (SNPRM Comment
                #128). The Contact Lens Institute criticized the Commission for
                failing to address the fact that the information conveyed in a
                telephonic communication needs to be reduced to a writing by the
                prescriber's office so it can be compared to patient records, a
                process that must in virtually all cases be conducted separately
                from the call itself. SNPRM Comment #79. It follows, according to
                CLI, that written requests are more efficient and effective
                communication tools for both sellers and prescribers.
                ---------------------------------------------------------------------------
                B. Comments About, and Adoption of, Requirements Proposed in the SNPRM
                To Improve Quality of Automated Telephone Messages
                 In the SNPRM, the Commission recognized that additional
                requirements for automated verification calls were necessary to relieve
                the burden on prescribers and reduce potential health risks to patients
                from incomplete or incomprehensible automated telephone messages.
                Specifically, the Commission noted that prescribers must be able to
                understand automated messages so they can, if necessary, respond to
                sellers to prevent improper sales.\297\ As a result, the Commission
                proposed, via an amendment to Sec. 315.5, requirements for sellers to
                improve verification calls that use, in whole or in part, an automated
                message. For these calls, sellers must: (1) Record the entire call; (2)
                commence the call by identifying it as a request for prescription
                verification; (3) provide the information required by Sec. 315.5(b) in
                a slow and deliberate manner and at a reasonably understandable volume;
                and (4) give the prescriber the option to repeat the information.\298\
                ---------------------------------------------------------------------------
                 \297\ SNPRM, 16 FR at 24685.
                 \298\ SNPRM, 16 FR at 24685.
                ---------------------------------------------------------------------------
                 Commenters were largely in favor of the Commission's proposals to:
                (1) Commence the call by identifying it as a request for prescription
                verification; (2) provide the information required by Sec. 315.5(b) in
                a slow and deliberate manner and at a reasonably understandable volume;
                \299\ and (3) give the prescriber the option to repeat this
                information.\300\ Seller 1-800 CONTACTS indicated that its verification
                messages already comply with these proposed requirements, and the NAOO
                indicated that its members have not identified any significant burdens
                in complying with these requirements.\301\ CooperVision indicated that
                these proposals, along with some of the Commission's other proposals,
                helped address some of the more troubling issues with automated
                messages.\302\ On the other hand, the Contact Lens Institute, comprised
                of the major contact lens manufacturers, indicated that the
                Commission's proposed measures demonstrate the impossibility of
                assuring that automated messages provide effective communication of
                required information and a reliable basis for passive
                verification.\303\ For instance, it stated that the Commission's
                requirements to commence the call by identifying it as a request for
                prescription verification and to give prescribers an option to repeat
                assumes that prescribers will have live staff available 24 hours a day
                and will not need to rely on recording devices.\304\
                ---------------------------------------------------------------------------
                 \299\ The Commission notes that these criteria have always been
                part of the Rule, but it has determined that they should be
                expressly set forth in the Rule. See 81 FR 88540 (``A request
                delivered by an automated telephone system does not comply with the
                Rule if it is not delivered in a volume and cadence that a
                reasonable person can understand.'').
                 \300\ American Optometric Association (SNPRM Comment #96)
                (stating support for these requirements, but expressing concern they
                are coming too late); National Association of Optometrists &
                Opticians (SNPRM Comment #129); 1-800 CONTACTS (SNPRM Comment #135);
                Johnson & Johnson Vision Care, Inc. (SNPRM Comment #151) (expressing
                approval for these provisions should the Commission not prohibit
                these calls altogether).
                 \301\ National Association of Optometrists & Opticians (SNPRM
                Comment #129); 1-800 CONTACTS (SNPRM Comment #135).
                 \302\ CooperVision, Inc. (SNPRM Comment #130).
                 \303\ Contact Lens Institute (SNPRM Comment #79). Members of the
                Contact Lens Institute are Alcon Vision, Bausch + Lomb, CooperVision
                and Johnson & Johnson Vision Care. The Commission notes that the
                opinions expressed in the CLI's comment do not always conform with
                the opinions of the manufacturers as expressed in their individually
                filed comments.
                 \304\ It also described the Commission's requirement to deliver
                the message in a ``slow and deliberate manner'' and at a
                ``reasonable volume'' as so vague as to be potentially
                unenforceable. Contact Lens Institute (SNPRM Comment #79. The
                Commission disagrees with this assessment, finding that these
                conditions are met if, upon listening to a call, the required
                information is comprehensible to a reasonable person.
                ---------------------------------------------------------------------------
                 The Commission does not find these criticisms compelling. The
                Commission recommended these proposals with an awareness that sometimes
                prescribers' offices take these calls live and, at other times, the
                calls are left on recording devices. An option to repeat the
                information is helpful if a person answers live. If not, the prescriber
                has the ability to replay the message from the recording device.
                Similarly, commencing the call by identifying it as a request for
                prescription verification should help ensure that the prescriber's
                office is ready to take the relevant information down, both when
                answering live and when playing the message from a recording device. As
                a
                [[Page 50690]]
                result, the Commission is implementing these amendments in its Final
                Rule.
                C. The Commission's Proposal Requiring Sellers To Record Automated
                Telephone Messages
                 In the SNPRM, the Commission also requested comments on its
                proposed amendment to Sec. 315.5 to require sellers who verify
                prescriptions through automated telephone verification messages to
                record the entire call.\305\ Some commenters opposed the proposal,\306\
                while others supported it.\307\ 1-800 CONTACTS opposed the recording
                requirement, stating that it would impose a costly burden on sellers,
                is unnecessary because the Commission lacks evidence of a systematic
                problem with automated calls, and would not facilitate enforcement or
                improve compliance.\308\ This seller also commented that the
                requirement combined with state wiretapping laws may cause sellers to
                switch to other, perhaps less-reliable verification methods.\309\ In
                favor of the proposal, the AOA indicated that the cost of compliance is
                justified given the widespread issues with robocalls that currently
                exist.\310\
                ---------------------------------------------------------------------------
                 \305\ SNPRM, 84 FR at 24685.
                 \306\ Contact Lens Institute (SNPRM Comment #79); 1-800 CONTACTS
                (SNPRM Comment #135); Consumer Reports (Comment #133).
                 \307\ The Health Care Alliance for Patient Safety (SNPRM Comment
                #128), CooperVision, Inc. (SNPRM Comment #130), and Johnson &
                Johnson Vision Care, Inc. (SNPRM Comment #151), supported the
                recording requirement if the Commission did not ban automated
                telephone messages altogether. See also American Optometric
                Association (SNPRM Comment #96); National Association of
                Optometrists & Opticians (SNPRM Comment #129).
                 \308\ 1-800 CONTACTS (SNPRM Comment #135).
                 \309\ Id.
                 \310\ American Optometric Association (SNPRM Comment #96).
                ---------------------------------------------------------------------------
                 In support of its position that the recording requirement is
                unnecessary, 1-800 CONTACTS pointed to the Commission's statement in
                the SNPRM that it does not have empirical data showing the frequency of
                verification calls that contain incomplete or incomprehensible
                automated messages.\311\ The seller further commented that the number
                of sellers that use this particular technology is likely limited and
                the Commission can much more easily acquire the evidence necessary to
                investigate complaints and bring an enforcement action in appropriate
                circumstances.\312\ It stated that ``the same cost-benefit approach
                that justifies additional recordkeeping for prescription release,
                counsels against additional superfluous and costly regulation and in
                favor of targeted enforcement.'' \313\ Consumer Reports noted that it
                was not aware of noncompliance similar to that of prescribers' failure
                to release prescriptions.\314\
                ---------------------------------------------------------------------------
                 \311\ 1-800 CONTACTS (SNPRM Comment #135).
                 \312\ 1-800 CONTACTS stated that the Commission lacked evidence
                about whether problems occur with automated calls of more than a
                limited number of sellers, and if it is a limited number of sellers,
                the Commission should consider education and enforcement efforts
                instead of rule changes. For instance, the Commission could obtain
                the recording itself from prescribers who assert that they have
                received an invalid or incomprehensible verification call. Id.
                Although the Commission could obtain such recordings from
                prescribers, the information would not be complete. Without the
                ability to obtain recordings from the seller, the Commission would
                be unable to assess if the call the seller relied on was compliant,
                was non-compliant (violating the Rule) but an anomaly, or was part
                of a widespread use of problematic calls. Moreover, as to its point
                about the limited number of sellers making these calls, new contact
                lens sellers are routinely entering the market and the Commission
                needs to ensure it can enforce against them if it receives
                complaints.
                 \313\ 1-800 CONTACTS (SNPRM Comment #135).
                 \314\ Consumer Reports (SNPRM Comment #133).
                ---------------------------------------------------------------------------
                 The Commission lacks empirical data on this issue, as noted in the
                SNPRM.\315\ However, it is undisputed that automated telephone messages
                are a commonly used method of verification. Moreover, these calls
                impose a cost on prescribers, and there are potential health risks to
                patients from incomplete and incomprehensible automated telephone
                requests.\316\ In fact, many commenters have indicated problems with
                the quality of automated telephone messages.\317\ The AOA commented in
                response to the SNPRM that, in its survey of 629 doctors of optometry,
                85% reported that automated calls for prescription verifications have
                increased in the past five years, and 88% indicated that the quality of
                such calls has decreased in the past five years.\318\ These commenters
                have exposed an issue for enforcement: Without a call recording,\319\
                the Commission cannot reliably assess whether that call was compliant
                and further whether the seller has a pattern of placing non-compliant
                calls (and selling after such calls).
                ---------------------------------------------------------------------------
                 \315\ SNPRM, 84 FR at 24685.
                 \316\ Id.
                 \317\ NPRM, 81 FR at 88538 nn.152, 154, 155; SNPRM, 84 FR at
                24684 n.270. See also CLR Panel IV Tr., supra note 121, at 8
                (statement of David Cockrell that the office can't understand many
                of the robocalls); id. at 8 (statement of Tim Steinemann that many
                robocalls are unintelligible or cut off).
                 \318\ American Optometric Association (SNPRM Comment #96).
                However, because the AOA did not provide the survey itself or the
                data from the survey, the Commission does not rely on it as more
                than anecdotal evidence.
                 \319\ The Commission has received numerous comments from
                prescribers indicating that they have received non-compliant
                messages, some of which were left on their answering machines, yet
                has received very few actual recordings of these messages from
                prescribers.
                ---------------------------------------------------------------------------
                 1-800 CONTACTS commented that it is an unnecessary burden for
                sellers to record and retain copies of thousands of identical
                verification calls, the costs of which would exceed the benefits.\320\
                Consumer Reports shared this sentiment and suggested that it would be
                more reasonable for the Commission to require sellers to retain a
                sample recording of the standard script, leaving blanks for
                prescription and patient details.\321\ The Commission believes that
                seeing a script of information relayed or a sample recording has
                limited utility. A script or a sample recording would not reveal
                whether the required information was transmitted for any particular
                automated telephone message or if, for instance, required information
                was transmitted before a representative or machine answered, after an
                answering machine cut off, when a prescriber's office put the call on
                hold, or over hold music, in which case the call could not be lawfully
                used as a basis for the sale.\322\ Further, a script or sample
                recording would not permit the Commission to assess whether each call
                was delivered in a ``slow and deliberate manner'' and at a ``reasonably
                understandable volume.'' Without knowing this information, the
                Commission would be unable to determine conclusively whether any
                particular verification request was valid. Therefore, the Commission is
                not adopting this recommendation.
                ---------------------------------------------------------------------------
                 \320\ 1-800 CONTACTS (SNPRM Comment #135).
                 \321\ Consumer Reports (SNPRM Comment #133).
                 \322\ One commenter requested a requirement for online sellers
                to maintain files of recordings of each verification attempt made by
                automated message for a period of no less than three years. Health
                Care Alliance for Patient Safety (SNPRM Comment #128). The
                Commission is only requiring sellers to maintain recordings of
                automated telephone calls that are the basis for the sale, and to
                maintain these recordings for three years. There is no need under
                the Rule for sellers to maintain recordings of unsuccessful
                verification attempts.
                ---------------------------------------------------------------------------
                 1-800 CONTACTS asserted that the requirement to record verification
                calls would not only impose additional regulatory burdens on sellers,
                but also expose sellers to legal risk.\323\ The seller argued that by
                recording telephone communications, sellers might risk violating two-
                party consent laws in the states that require all parties on the call
                to consent to recordings.\324\ After
                [[Page 50691]]
                reviewing the relevant statutes and applicable case law, the Commission
                does not believe sellers risk conducting illegal calls by recording
                them.\325\
                ---------------------------------------------------------------------------
                 \323\ 1-800 CONTACTS (SNPRM Comment #135).
                 \324\ Twelve states have such a requirement: California,
                Connecticut, Delaware, Florida, Illinois, Maryland, Massachusetts,
                Montana, Nevada, New Hampshire, Pennsylvania, and Washington. See
                Cal. Penal Code Sec. 632(a), (c) (West 2019); Conn. Gen. Stat.
                Sec. 52-570d(a) (West 2019); Del. Code Ann. tit. 11, Sec. 2402(a),
                (c)(4) (West 2019); Fla. Stat. Ann. Sec. 934.03(1), (3)(d) (West
                2019); 720 Ill. Comp. Stat. Ann. 5/14-2(a) (West 2019); Md. Code.
                Ann., Cts. & Jud. Proc. Sec. 10-402(a), (c)(3) (West 2019); Mass.
                Gen. Laws Ann. ch. 272, Sec. 99(C) (West 2019); Mont. Code Ann.
                Sec. 45-8-213(1)(c), (2)(a)(iii) (West 2019); Nev. Rev. Stat. Ann.
                Sec. 200.620 (West 2019); N.H. Rev. Stat. Ann. Sec. 570-A:2
                (2019); 18 Pa. Stat. and Cons. Stat. Ann. Sec. 5703, 5704(4) (West
                2019); Wash. Rev. Code Ann. Sec. 9.73.030(1), (3) (West 2019). It
                is also possible that Michigan has a two-party consent law, although
                interpretations of the law differ, and the issue has not been firmly
                resolved. See Mich. Comp. Laws Ann. Sec. 750.539c (``Any person . .
                . who willfully uses any device to eavesdrop . . . without the
                consent of all parties thereto . . . is guilty of a felony). Compare
                AFT Mich. v. Project Veritas, 378 F. Supp. 3d 614, 620 (E.D. Mich.
                2019) (finding statute prohibits participants from recording private
                discourse of any other person involved in the conversation unless
                all persons consent); with Sullivan v. Gray, 324 N.W.2d 58, 60
                (Mich. Ct. App. 1982) (finding statute does not require two-party
                consent because it only prohibits eavesdropping, which is defined as
                recording the ``private discourse of others.'' (emphasis added)).
                 \325\ Of course, the Commission cannot predict precisely how
                different jurisdictions will apply state laws. However, the
                Commission is unaware of a party ever being held liable for
                violating two-party consent requirements in a situation where the
                call contained a disclosure message at its onset. The Commission
                further notes that jurisdictions take different approaches to
                deciding which state law applies for interstate or multi-state phone
                calls. See, e.g., Ditech Fin. LLC v. Buckles, 401 P.3d 215 (Nev.
                2017). Therefore, when recording calls with prescribers located in
                other states, sellers should abide by the more stringent law that
                applies or obtain the consent of all parties to the communication.
                As the Commission stated in the SNPRM, 84 FR at 24685 n.288, sellers
                are responsible for determining compliance with state law taping
                requirements.
                ---------------------------------------------------------------------------
                 For instance, though the California penal code prohibits
                eavesdropping on or recording confidential communications without two-
                party consent, the code excludes from the definition of ``confidential
                communication'' any circumstances ``in which the parties to the
                communication may reasonably expect that the communication may be
                overheard or recorded.'' \326\ The California Supreme Court has
                stressed that Sec. 632 of the California penal code does not preclude
                parties from ever recording conversations, but rather prohibits parties
                from doing so ``secretly'' or ``surreptitiously,'' declaring that a
                business would not violate the state's wiretapping laws if it advised
                parties to a communication of its intent to record the call at the
                outset of the conversation.\327\ Similarly, in Massachusetts, a person
                cannot willfully intercept any wire or oral communication, with
                ``interception'' defined in the statute as secretly hearing, secretly
                recording, or aiding another to do so without the parties'
                consent.\328\ The Massachusetts Supreme Court has ruled that a system
                that expressly notifies the parties that the call will be recorded does
                not commit an interception because the system does not record the
                conversation in secrecy.\329\ Thus, in California and Massachusetts,
                sellers who provide a standard notification at the beginning of the
                call, which has become customary in many business communications, are
                unlikely to risk violating state wiretapping laws.
                ---------------------------------------------------------------------------
                 \326\ Cal. Penal Code Sec. 632(a), (c).
                 \327\ Kearney v. Salomon Smith Barney, Inc., 137 P.3d 914, 930
                (Cal. 2006); see also Hataishi v. First Am. Home Buyers Prot. Corp.,
                168 Cal. Rptr. 3d 262, 271 (Cal. Ct. App. 2014) (stating California
                consumers are accustomed to receiving notice of a business's
                intention to record a call); CS Wang & Assoc. v. Wells Fargo Bank,
                N.A., 305 F. Supp. 3d 864, 885 (N.D. Ill. 2018) (Under the
                California Invasion of Privacy Act, ``the baseline assumption in
                situations where the recorded party does not initiate the call, does
                not have a prior relationship with the caller, and does not receive
                a warning at the outset of the call, is that it is reasonable for a
                party to expect that its conversation is not being recorded.'')
                (emphasis added).
                 \328\ See Mass. Gen. Laws Ann. ch. 272, Sec. 99(B)(4), (C)(1).
                 \329\ See Commonwealth v. Boyarsky, 897 N.E.2d 574, 579 (Mass.
                2008) (finding ``there was no interception because there was no
                secret recording, and the inquiry is at an end''); see also Marquis
                v. Google, Inc., No. SUCV2011-02808-BLS1, 2014 WL 4180400, at *12
                (Mass. Super. Ct. July 27, 2014) (``The core of the statute is . . .
                the prevention of the secret interception of wire communications . .
                . . In consequence, if a recording is `not made secretly,' it does
                `not constitute an `interception'' and there has been no violation
                of the statute.'').
                ---------------------------------------------------------------------------
                 Moreover, after reviewing the plain language of other state
                statutes requiring two-party consent and case law, the Commission
                concludes that if sellers express their intentions to record the
                conversation at the outset of each call, sellers located in or
                contacting prescribers in two-party consent states will not risk
                violating a state's respective wiretapping law. Announcements at the
                outset of the calls would prevent sellers from committing violations
                because prescribers can either provide or withhold consent. For
                instance, under Florida's and Maryland's statutes,\330\ as long as a
                party has received notice of an intent to record, the notified party
                can expressly or impliedly consent by remaining on the line.\331\ 1-800
                CONTACTS notes that a prescriber could effectively reject a valid
                method of verification--verification by telephone--by declining to give
                consent.\332\ In the event that a prescriber declines to consent to a
                recorded call containing an automated telephone verification message,
                sellers may make verification requests via email, live call, or fax.
                Sellers may also elect to leave automated telephone messages after
                hours on prescribers' answering machines. Such calls would not
                implicate wiretapping laws since the prescriber is not on the
                line.\333\
                ---------------------------------------------------------------------------
                 \330\ Fla. Stat. Ann. Sec. 934.03(2)(d); Md. Code. Ann., Cts. &
                Jud. Proc. Sec. 10-402(a), (c)(3).
                 \331\ See Levin v. Red Rock Fin. Servs., LLC, No. 70006, 2017 WL
                519414, at *1 (Nev. Ct. App. Jan. 30, 2017) (agreeing that summary
                judgment applying Nevada and Florida law had been properly granted
                because appellant ``necessarily heard the pre-recorded announcement
                during every phone call . . . and consequently gave implied consent
                to be recorded during each call by continuing with the call'')
                (emphasis added); Briddell v. State, No. 1220, 2016 WL 4698158, at
                *3-4 (Md. Ct. Spec. App. Sept. 7, 2016) (finding plaintiff ``was not
                forced to communicate . . . nor continue with the phone conversation
                after being notified that it would be recorded and monitored'' and
                consented to recording ``by continuing to speak after the [warning]
                messaged [had] played.'') (emphasis added). See also Wash. Rev. Code
                Ann. Sec. 9.73.030(3) (``[C]onsent shall be considered obtained
                whenever one party has announced to all other parties engaged in the
                communication or conversation, in any reasonably effective manner,
                that such communication or conversation is about to be recorded or
                transmitted.'').
                 \332\ 1-800 CONTACTS (SNPRM Comment #135).
                 \333\ Some prescribers commenting on the Rule have expressed
                concern that verification calls placed during non-business hours
                violate the Rule. See NPRM, 81 FR at 88544 and n.232. Sellers who
                leave compliant verification messages after hours do not violate the
                Rule as long as they wait the required eight business hours before
                selling lenses (assuming there is no communication from the
                prescriber invalidating or approving the message before that time
                period concludes).
                ---------------------------------------------------------------------------
                 Commenters also opined on whether the Commission should extend its
                recording requirement to verification calls that do not involve
                automated messages, i.e., live calls. 1-800 CONTACTS suggested that the
                requirement to record calls including automated messages should apply
                equally to live calls because sellers might otherwise have an incentive
                to outsource live verification calls to inexpensive call centers that
                can ``game the system'' by making it difficult for prescribers to
                understand or respond to live verification requests.\334\ On the other
                hand, the NAOO, without explanation, supported the Commission's
                recording requirement for automated calls as long as the Commission
                does not expand the requirement to apply to live calls.\335\
                ---------------------------------------------------------------------------
                 \334\ 1-800 CONTACTS (SNPRM Comment #135). The seller also
                pointed to the Commission's statement in the SNPRM that it does not
                know that a phone call with an automated message is necessarily less
                reliable than one with a live person. Id. (citing SNPRM, 84 FR at
                24685).
                 \335\ National Association of Optometrists and Opticians (SNPRM
                Comment #129).
                ---------------------------------------------------------------------------
                 For several reasons, the Commission declines to compel sellers to
                record live calls. Foremost, during live calls, a prescriber can ask a
                seller to repeat the message or to clarify unintelligible information,
                and can look up a patient's file in real time to verify the
                [[Page 50692]]
                prescription.\336\ In this setting, a seller is likely to limit any bad
                conduct. While bad actors could speak incoherently, exclude key
                information, or refuse to repeat the message when asked, the Commission
                has not received or seen evidence of such behavior, and the record does
                not reflect any other widespread issue involving the quality of live
                calls. Finally, the Commission considered mass merchandisers that
                verify prescriptions largely or exclusively by calling prescribers to
                obtain verification via a live call when a customer purchases lenses at
                the store. Because these sellers use their phone lines for a multitude
                of purposes unrelated to prescription verification, such as taking
                consumer orders or checking inventory for a consumer, it would be
                difficult to implement a recording system in compliance with this Rule.
                However, should the Commission receive complaints that show an issue
                with sellers' conduct on live calls, the Commission will reassess the
                need to require sellers to record live verification calls.
                ---------------------------------------------------------------------------
                 \336\ CLR Panel IV Tr., supra note 121, at 15 (statement of
                David Cockrell referring to how live calls provide opportunity for
                two-way conversation).
                ---------------------------------------------------------------------------
                D. The Final Rule Does Not Adopt Commenters' Additional Recommendations
                Regarding Automated Telephone Messages
                 A number of additional recommendations were suggested by commenters
                regarding calls that contain, in full or in part, automated
                messages.\337\ The Health Care Alliance for Patient Safety and Johnson
                & Johnson Vision Care requested that the FTC review and approve a
                transcript of sellers' automated telephone messages before sellers are
                permitted to use calls containing such messages.\338\ The Contact Lens
                Institute urged the Commission to require sellers to follow a
                ``specific script that includes standardized terms, a standardized
                order of presenting the required information, and a standardized
                pace,'' \339\ and to require sellers to document that they only use
                means of transmission that have been tested and shown to result in
                receipt of clear and unambiguous information at the receiving end of
                the call.\340\
                ---------------------------------------------------------------------------
                 \337\ The Contact Lens Institute (SNPRM Comment #79), Health
                Care Alliance for Patient Safety (SNPRM Comment #128), and Johnson &
                Johnson Vision Care, Inc. (SNPRM Comment #151) proposed these
                additional requirements in the event that the Commission declined to
                prohibit use of verification via automated telephone messages.
                 \338\ Health Care Alliance for Patient Safety (SNPRM Comment
                #128); Johnson & Johnson Vision Care, Inc. (SNPRM Comment #151).
                 \339\ Contact Lens Institute (SNPRM Comment #79). Alcon Vision
                made a similar recommendation. See SNPRM Comment #117.
                 \340\ Contact Lens Institute (SNPRM Comment #79).
                ---------------------------------------------------------------------------
                 The Commission is not implementing these recommendations. The
                information that sellers need to include to make a valid verification
                request is clearly delineated in Sec. 315.5(b), (d)(2), and (d)(4) of
                the Final Rule.\341\ The Commission does not believe that reviewing and
                approving a transcript would be an effective use of its resources
                because it is the call itself that ultimately determines whether there
                is a valid verification request. Further, while there is some utility
                in providing a script so prescribers receive the information in a
                predictable manner, the Commission is not convinced that there is only
                one effective way for a seller to comply with the Rule, or that this
                requirement is necessary.\342\ The Rule already indicates what
                information needs to be included in the message, and the additional
                requirements the Commission is implementing should make it easier for
                prescribers to obtain the information. Should seller verification
                messages be deficient in providing all the required information,
                prescribers should notify the seller. Moreover, assuming a seller is
                complying with the Rule by recording calls that contain these messages,
                the Commission can ascertain whether the call included all the required
                information (and whether the seller ultimately sold lenses pursuant to
                an invalid verification call). A review of the recording will provide
                better information on compliance than would knowing that the seller
                used a transcript--including an FTC-approved transcript--or a means of
                transmission that the seller has tested and documented as effective.
                ---------------------------------------------------------------------------
                 \341\ Commission review of a script would not reveal whether the
                seller was complying with Section 315.5(d)(3) and (4) of the Final
                Rule (the requirements as to cadence, volume, and the ability to
                repeat the information).
                 \342\ Similarly, 1-800 CONTACTS requested a requirement that a
                pre-recorded message be limited to providing only the information
                required under the Rule and not include extraneous information that
                could make the call confusing or more burdensome. SNPRM Comment
                #135. Although the Commission cautions sellers against including
                extraneous information, it has not seen evidence of a widespread use
                of calls including such information and thus is not implementing
                this recommendation.
                ---------------------------------------------------------------------------
                 The Health Care Alliance for Patient Safety and Johnson & Johnson
                Vision Care also requested a requirement that online sellers confirm
                that automated calls are answered by a person at the prescriber's
                office, as opposed to a recording device, before initiating an
                automated message.\343\ In essence, they are asking for a requirement
                that all verification calls be placed during a prescriber's business
                hours, presumably the time when prescribers' phone lines are
                staffed.\344\ These commenters also requested that the Commission
                require online sellers who use automated telephone messages to provide,
                for prescriber's use, a centralized call-back number and have the call-
                back number staffed by a person from the seller.\345\ In the same vein,
                CooperVision commented that the Commission should require sellers to
                provide the means for the prescriber to disrupt a verification call
                that uses, in whole or in part, an automated message, in order to
                connect with a person at the seller to provide correct
                information.\346\ Without this requirement, according to CooperVision,
                eye care professionals are limited in their ability to correct
                information that is important for the patient's eye health or that
                could prevent improper substitution of lenses.\347\
                ---------------------------------------------------------------------------
                 \343\ Health Care Alliance for Patient Safety (SNPRM Comment
                #128); Johnson & Johnson Vision Care, Inc. (SNPRM Comment #151).
                 \344\ It is not clear that this option would be desired by
                prescribers, some of whom have indicated that they do not have time
                during business hours to respond to these requests or that such
                calls tie up their phone lines. See NPRM, 81 FR 88539 n.158.
                 \345\ Id.; see also CLR Panel IV Tr., supra note 121, at 10
                (statement of David Cockrell that the office needs to be able to
                contact the seller immediately and it ``can't even leave a
                message'').
                 \346\ CooperVision, Inc. (SNPRM Comment #130).
                 \347\ CooperVision also stated confusion as to whether the
                Commission's requirement for sellers to provide an option to repeat
                the verification information included a requirement for sellers to
                provide the means for the prescriber to immediately disrupt an
                automatic call in order to connect with a live person. SNPRM Comment
                #130. It does not.
                ---------------------------------------------------------------------------
                 The Rule does not require sellers' communication via telephone,
                email, or fax to occur during business hours. The Rule requires,
                instead, that sellers wait eight business hours after a valid
                verification call to sell the lenses. Moreover, the Rule already
                requires the seller to provide the name of a contact person at the
                seller's company, including facsimile and telephone numbers.\348\
                Should a prescriber inform the seller within eight business hours that
                the prescription was inaccurate, expired, or otherwise invalid, the
                seller cannot lawfully sell those contact lenses. If a prescriber
                informs a seller that the verification request itself was non-
                compliant, the seller is on notice that it may need to provide another
                verification request prior to selling the lenses. The prescriber need
                not relay that information to a person at the seller, whether during
                the verification
                [[Page 50693]]
                call or at other times.\349\ Instead, it is sufficient notice for a
                prescriber to leave a voicemail, or send a facsimile, that provides the
                seller with enough information so as to identify the consumer or order
                being called about (a consumer name, reference number, or even the
                prescriber's name with the date of the verification call could be
                adequate), and that the prescription is inaccurate, expired, or
                otherwise invalid.\350\ In addition, requiring sellers to reach a
                person (and not a machine) at the prescriber's office, or to provide a
                call-back number that is answered by a person (and not a machine),
                would mean either that sellers would need to have agents available at
                all times, or else only contact prescribers during business hours for
                both the seller and prescriber, which may be difficult if they are
                located in different time zones. Requiring that sellers have someone
                available at all times to respond to prescriber inquiries would also be
                costly for sellers, with no readily apparent countervailing benefit.
                For these reasons, the Commission declines to implement a requirement
                that sellers ensure that automated telephone messages are answered by a
                person at the prescriber's office, as opposed to a recording device, or
                that prescribers be able to reach a live person at the seller.\351\
                ---------------------------------------------------------------------------
                 \348\ 16 CFR 315.5(b)(6).
                 \349\ If a seller does not maintain a person to answer the phone
                number it provides, it must provide an opportunity for the
                prescriber to leave a message. A seller that does not check its
                voicemail runs the risk of selling lenses after a prescriber has
                timely invalidated or corrected the prescription, thereby violating
                the Rule.
                 \350\ Final Rule Sec. 315.5(e) requires the prescriber to
                specify the basis for the inaccuracy or invalidity of the
                prescription, and if the prescription is inaccurate, the prescriber
                shall correct it. Final Rule 16 CFR 315.5(e). Even if the prescriber
                violates the Rule by failing to specify the basis for the inaccuracy
                or invalidity, or by failing to correct the prescription, the seller
                is still prohibited from selling if a prescriber informs the seller
                that the prescription is inaccurate, expired, or otherwise invalid
                within the eight-business-hour time period.
                 \351\ The Commission notes that some sellers have agents who
                stay on the line to ensure that, before commencing the automated
                message, an individual at the prescriber's office has answered the
                phone, or that the answering machine has picked up before leaving
                the message. Such a practice helps ensure that the beginning of the
                message is not cutoff or played over hold music.
                ---------------------------------------------------------------------------
                 The Health Care Alliance for Patient Safety and Johnson & Johnson
                Vision Care further requested a requirement that online sellers verify
                that they are making verification calls to the office of a legitimate
                eye care professional. The Commission is aware of allegations of
                sellers making verification calls to numbers clearly not affiliated
                with eye care prescribers. The Rule requires a seller to sell contact
                lenses in accordance with a contact lens prescription for the patient
                that, if not presented to the seller, is verified by direct
                communication.\352\ Of course, for prescription verification to be
                meaningful, that verification must go to the consumer's eye care
                prescriber. Although the seller does not know whether the prescriber
                contact information provided by the consumer is that of the consumer's
                own eye care prescriber, to ensure that its verification request
                complies with the Rule, it is incumbent upon the seller to ascertain
                whether the number provided by the consumer is for an eye care
                prescriber. If it is apparent from the consumer's entry itself,\353\ or
                from the seller's research on the internet or otherwise, that the
                number provided is not affiliated with a prescriber, or if it cannot be
                determined whether it is, the seller should either reach out to the
                consumer to obtain better contact information or cancel the order.
                Calls to numbers clearly not associated with eye care prescribers are
                not compliant verification requests, and any sales made pursuant to
                such requests violate the Rule. The Commission intends for this notice
                to provide sufficient guidance for sellers and does not see a need to
                amend the Rule to address this issue.
                ---------------------------------------------------------------------------
                 \352\ 16 CFR 315.5(a).
                 \353\ For instance, sellers should not verify a prescription
                when the consumer identifies the prescriber as ``Santa Claus.''
                Similarly, sellers should not place verification calls to phone
                numbers that consumers list as the prescriber phone number when that
                phone number is the same number a consumer lists as her own contact
                number.
                ---------------------------------------------------------------------------
                 The Commission is implementing the recommendations outlined in the
                SNPRM for automated telephone messages in the Final Rule, without
                modification. CooperVision requested guidance on how the Commission
                intends to interpret and enforce these provisions.\354\ This notice
                should provide sellers with information to assist them in complying
                with the new rule requirements. The Commission also plans to publish
                education on these Final Rule requirements. As to enforcement, should
                the Commission receive complaints about the quality of automated calls,
                it can request that the seller produce the recording of the call in
                question.
                ---------------------------------------------------------------------------
                 \354\ CooperVision, Inc. (SNPRM Comment #130).
                ---------------------------------------------------------------------------
                IV. Prescribers' Selection of Communication Mechanism
                 In the NPRM, the Commission pointed out that the Act does not
                permit prescribers to limit the communication mechanism sellers may use
                to submit requests for verifying prescriptions, and that sellers are
                able to use any or all of the three delineated methods, telephone,
                facsimile, or electronic mail.\355\
                ---------------------------------------------------------------------------
                 \355\ NPRM, 81 FR at 88542.
                ---------------------------------------------------------------------------
                 In response, prescribers continued to request that they be able to
                select the method of communication used to submit verification requests
                from among telephone, facsimile, or electronic mail.\356\ Johnson &
                Johnson Vision Care commented that it wished to work with the
                Commission and Congress to improve prescriber-seller communications,
                such as by allowing a prescriber to select her preferred method for
                verification requests.\357\ The AOA commented that the Commission took
                a step in the right direction when it suggested that sellers evaluate
                whether honoring prescriber preferences with regard to communication
                method would increase the speed and efficiency of the verification
                process.\358\ It nevertheless urged the Commission to provide more
                instruction to sellers, and to outline the verification-related
                complaints that the Commission has received, so prescribers and sellers
                can work together to ensure patients receive the contact lenses that
                were prescribed.\359\
                ---------------------------------------------------------------------------
                 \356\ O'Daniel (NPRM Comment #179); Krattli (NPRM Comment
                #1976).
                 \357\ Johnson & Johnson Vision Care, Inc. (NPRM Comment #4327).
                The manufacturer also requested that sellers be required to provide
                an option, as part of a verification message, for the prescriber's
                office to elect an alternate means to receive the request, and an
                alternate time frame after which the window to respond to
                verification requests must be completed. Johnson & Johnson Vision
                Care, Inc. (SNPRM Comment #151).
                 \358\ American Optometric Association (NPRM Comment #3830).
                 \359\ Id.
                ---------------------------------------------------------------------------
                 The Commission reiterates its suggestion that sellers and
                prescribers work together to ensure that patients receive their
                prescribed lenses. As stated in the NPRM, the Commission requests
                sellers to consider whether the speed and efficiency of the
                verification process would be increased by accommodating prescribers'
                requests to contact them with verification requests via a certain
                method.\360\ However, because the Act defines ``direct communication''
                to include three different communication mechanisms that sellers may
                use--telephone, facsimile, or electronic mail--the Act does not permit
                prescribers to limit the communication mechanisms sellers may
                [[Page 50694]]
                use to submit verification requests.\361\ The Commission is therefore
                not making any changes to the Rule in this area.
                ---------------------------------------------------------------------------
                 \360\ NPRM, 81 FR at 88542. Similarly, the seller should
                consider whether to accommodate prescribers' requests to contact
                them during specified time-periods (i.e., business hours, or after
                business hours).
                 \361\ See 15 U.S.C. 7603(g). The Commission came to the same
                conclusion in its initial rulemaking. 69 FR at 40497. The Commission
                recognizes that in practice, sellers' options may be limited. For
                instance, should a prescriber's office not have facsimile, a seller
                would be unable to complete a verification request via fax.
                ---------------------------------------------------------------------------
                V. Miscellaneous Passive Verification Issues
                A. Active Verification Is Not Required
                 In the NPRM, the Commission declined to propose replacing passive
                verification with active verification, despite concerns from many
                commenters.\362\ Commenters expressed concern that the passive
                verification system could easily be manipulated, for example, by a
                patient who provides false or incorrect prescriber information to a
                seller, or by a seller who sends the same verification request over and
                over again in the hope that the prescriber will fail to reply and deny
                one of them.\363\ However, because Congress decided to include a
                passive verification system in the Act, and the issues commenters
                raised were identical to those raised during the initial 2004
                rulemaking, the Commission chose not to revisit the decision to include
                passive verification.\364\
                ---------------------------------------------------------------------------
                 \362\ NPRM, 81 FR at 88543.
                 \363\ Id.
                 \364\ Id.
                ---------------------------------------------------------------------------
                 Following the NPRM, many commenters reiterated the same concerns
                with respect to passive verification, including that sellers could
                abuse the system or that consumers might obtain lenses without a
                prescription or receive incorrect lenses, and they advocated for a
                switch to active verification.\365\ Because these concerns are similar
                to those raised during the initial rulemaking in 2004 and because
                Congress mandated passive verification in the FCLCA, the Commission
                again declines to modify the Rule to require active verification.\366\
                However, the Commission has made several changes to the Rule aimed at
                improving the quality of automated verification calls, which will allow
                prescribers to more effectively prevent the sale of contact lenses when
                the prescription is inaccurate, expired, or otherwise invalid.\367\ The
                Commission has also improved patients' access to their prescriptions by
                implementing requirements enabling patients to obtain electronic copies
                and additional copies of their prescriptions, and to present their
                prescriptions directly to sellers, which should reduce the need for
                passive verification requests.\368\ The Commission recognizes that some
                sellers may engage in verification practices that violate the Rule's
                requirements \369\ and, for that reason, will continue to monitor the
                marketplace and investigate potential violations when appropriate.
                ---------------------------------------------------------------------------
                 \365\ See, e.g., Golden (WS Comment #1353); Weidel (WS Comment
                #2333); Gray (WS Comment #2730); Audia (NPRM Comment #698); Bazan
                (NPRM Comment #706); Dewart (NPRM Comment #897); Nixon (NPRM Comment
                #1510); Weissman (NPRM Comment #1676); Goshe (NPRM Comment #2597);
                Fritsch (NPRM Comment #2683); Garr (NPRM Comment #2858); Phan (NPRM
                Comment #3350). Some commenters continued to support passive
                verification. See 1-800 CONTACTS (WS Comment #3207); National
                Association of Optometrist and Opticians (WS Comment #3208) (``No
                changes are needed to the passive verification system.'').
                 \366\ The Commission also notes that nothing in the Rule
                prevents active verification by a seller. If it prefers, a seller
                can choose to actively verify a prescription. CLR Panel IV Tr.,
                supra note 121, at 5 (statement of Jennifer Sommer) (stating that
                Walmart often actively verifies prescriptions by calling the
                prescriber's office).
                 \367\ See Section III, supra; 16 CFR 315.5(c)(2), (d).
                 \368\ See Section II.C.5, supra, and Sections VII and VIII,
                infra.
                 \369\ 16 CFR 315.5(a)-(d).
                ---------------------------------------------------------------------------
                B. Concerns About Patient Manipulation
                 In the NPRM, the Commission declined to propose any changes to the
                Rule to address concerns that patients were manipulating the passive
                verification system by deliberately providing inaccurate prescriber
                information to the seller.\370\ The Commission noted that if
                prescribers received a verification request for an individual who was
                not their patient, they have the ability to respond that such request
                is invalid, which would prevent the sale under Sec. 315.5 of the Rule.
                Some commenters provided anecdotal evidence of instances where
                consumers have intentionally provided inaccurate information, but the
                Commission did not have any empirical evidence showing the frequency of
                this problem.\371\ Moreover, Congress was aware that passive
                verification was not a foolproof method to prevent verification of
                invalid prescriptions, but nonetheless mandated passive verification to
                balance the interests of consumer health and prescription portability.
                ---------------------------------------------------------------------------
                 \370\ NPRM, 81 FR at 88543.
                 \371\ Id.
                ---------------------------------------------------------------------------
                 In response to the NPRM, commenters continued to express concerns
                with patients being able to obtain contact lenses without a valid
                prescription, especially with only eight business hours to respond to a
                verification request, and with the potential health consequences.\372\
                To address concerns with patient manipulation of passive verification,
                commenters advocated using an active verification system, requiring
                that a prescription be presented, changing the method used to send
                verification requests, or increasing the amount of time for a
                prescriber to respond.\373\
                ---------------------------------------------------------------------------
                 \372\ See, e.g., Johnson & Johnson Vision Care, Inc. (SNPRM
                Comment #151); Lem (WS Comment #470); Dillehay (WS Comment #822);
                Baird (WS Comment #1918); Hemler (WS Comment #2312); Patel (WS
                Comment #2691); Gray (WS Comment #2730); Bottjer (WS Comment #3378);
                Tuttle (NPRM Comment #161); Gilberg (NPRM Comment #198); Moy (NPRM
                Comment #382); Engler (NPRM Comment #453); Francis (NPRM Comment
                #588); Stott (NPRM Comment #687); Kempf (NPRM Comment #915);
                McPherson (NPRM Comment #3397); Schlater (NPRM Comment #3504);
                Bengoa (NPRM Comment #3600); Jackson (NPRM Comment #3736).
                 \373\ See, e.g., Contact Lens Association of Ophthalmologists,
                Inc. (WS Comment #770); Northsight Vision Care Center (WS Comment
                #1196); Golden (WS Comment #1353); Begeny-Mahan (WS Comment #1702)
                (requesting that the eight-business-hour period be changed to forty-
                eight hours); Kirkconnell (WS Comment #1754) (requesting two
                business days to respond and stating that requests should be faxed);
                American Society of Cataract and Refractive Surgery (WS Comment
                #3142) (advocating for extending the eight-business-hour time-period
                for passive verification to five business days); Bazan (NPRM Comment
                #706); Garr (NPRM Comment #2858); Greitzer (NPRM Comment #3388).
                ---------------------------------------------------------------------------
                 The Commission recognizes prescribers' concerns about the potential
                health effects on patients who wear non-prescribed lenses. However, as
                noted in the NPRM, Congress chose the passive verification framework as
                a way to balance consumer health and prescription portability.\374\
                Congress also allowed verifications by direct communication, which it
                defined as including telephone, facsimile, and electronic mail.\375\
                Congress was aware that passive verification was not a perfect method
                to prevent patients from deliberately providing incorrect
                information.\376\ The Commission does not have any evidence, aside from
                anecdotal reports, showing the extent to which patients are
                intentionally providing incorrect information to a seller in order to
                obtain contact lenses. Thus, the Commission does not believe that
                significant modifications to the Rule to address the concern about
                consumers submitting inaccurate prescriber information are warranted.
                ---------------------------------------------------------------------------
                 \374\ NPRM, 81 FR at 88543.
                 \375\ 15 U.S.C. 7603.
                 \376\ NPRM, 81 FR at 88543.
                ---------------------------------------------------------------------------
                 However, in its Final Rule, the Commission has implemented several
                changes to improve verification calls that use an automated telephone
                system, which will make it easier for prescribers to deny requests
                based on inaccurate prescriber information. These changes
                [[Page 50695]]
                include identifying at the start of the call that it is a prescription
                verification request, delivering the information in a slow and
                deliberate manner and at a reasonably understandable volume, and giving
                the prescriber the option to repeat the call.\377\ Prescribers will be
                better able to identify the relevant patient information and inform
                sellers during the eight-business-hour period that the request is
                invalid.\378\ The Commission will also continue to monitor the
                marketplace, investigate any sellers encouraging patients to provide
                false information, and continue its consumer education efforts
                communicating the importance of having a prescription when purchasing
                contact lenses.\379\
                ---------------------------------------------------------------------------
                 \377\ See Section III.
                 \378\ 16 CFR 315.5(d).
                 \379\ See, e.g., Federal Trade Commission, Halloween know-how:
                Cosmetic contacts require an Rx, https://www.consumer.ftc.gov/blog/2019/10/halloween-know-how-cosmetic-contacts-require-rx; Federal
                Trade Commission, Prescription Glasses and Contact Lenses, https://www.consumer.ftc.gov/articles/0116-prescription-glasses-and-contact-lenses (``All contact lenses--even ones just meant to change your
                appearance--require a prescription.'').
                ---------------------------------------------------------------------------
                C. Eight-Business-Hour Time Frame Is Appropriate
                 In the NPRM, the Commission considered commenters' concerns that
                the eight-business-hour time frame was too short and that verification
                calls were being placed outside of business hours or when the
                prescriber's office was closed.\380\ The Commission declined to
                lengthen or otherwise modify the eight-business-hour time frame during
                which a prescriber must respond to a verification request.\381\ The
                Commission did not find sufficient evidence quantifying how the eight-
                business-hour time frame imposed a significant burden or showing that a
                significant number of prescribers were unable to respond to the
                verification requests within the allotted time. The Commission further
                noted that there have been no compelling changes to the marketplace
                since the Rule was implemented in 2004 that would justify extending the
                period beyond eight business hours.
                ---------------------------------------------------------------------------
                 \380\ NPRM, 81 FR at 88544-5. Other concerns about passive
                verification, unrelated to the length of time a prescriber has to
                respond to a verification request, are addressed in Sections III,
                IV, and V.A and B.
                 \381\ Id.
                ---------------------------------------------------------------------------
                 In response to the NPRM, some commenters indicated that eight
                business hours constituted a sufficient period for a prescriber to
                respond to a verification request.\382\ However, other commenters
                continued to express concerns with the limited time frame,\383\
                particularly due to the potential negative health consequences for
                patients wearing non-prescribed lenses, should a prescriber fail to
                deny an invalid verification request in time.\384\ Many prescribers
                wrote that eight business hours was just not a sufficient amount of
                time to respond due to, for example, busy offices, limited staff, high
                volume of requests, and regular office closures on business days.\385\
                ---------------------------------------------------------------------------
                 \382\ Coalition for Contact Lens Consumer Choice (WS Comment
                #3239); Consumer Action (NPRM Comment #3721); Consumers Union (NPRM
                Comment 3969) (stating that eight business hours ``was generally
                sufficient and has proven workable,'' but suggesting that the period
                could be changed to twenty-four hours with weekends and holidays
                excluded); see also CLR Panel IV Tr., supra note 121, at 16
                (statement of Cindy Williams) (stating that eight hours is
                sufficient time to respond).
                 \383\ See, e.g., Becker (WS Comment #571); Contact Lens
                Association of Ophthalmologists, Inc. (WS Comment #770); Begeny-
                Mahan (WS Comment #1702) (requesting that the eight-business-hour
                period be changed to forty-eight hours); Kirkconnell (WS Comment
                #1754) (requesting two business days to respond and stating that
                requests should be faxed); American Society of Cataract and
                Refractive Surgery (WS Comment #3142) (advocating for extending the
                eight-business-hour time-period for passive verification to five
                business days); Hanen-Smith (NPRM Comment #154); Cade (NPRM Comment
                #2163) (suggesting that sellers should exclude a weekday from the
                eight-business-hour calculation if they become aware that the
                prescriber's office is closed); American Academy of Opthalmology
                (NPRM Comment #3657) (proposing lengthening the response period to
                two business days); Coalition for Patient Vision Care Safety (NPRM
                Comment #3883); Contact Lens Association of Ophthalmologists (NPRM
                Comment #4259) (asking that the period be extended to two days).
                 \384\ See, e.g., Rhee (WS Comment #3468); Meyers (NPRM Comment
                #173); Gilberg (NPRM Comment #198); Engler (NPRM Comment #453);
                Kempf (NPRM Comment #915); McPherson (NPRM Comment #3397); American
                Society of Cataract and Refractive Surgery (NPRM Comment #3820);
                Tesinsky (NPRM Comment #4012).
                 \385\ Boyer (SNPRM Comment #59); Becker (WS Comment #571)
                (recommending two business days); Contact Lens Association of
                Ophthalmologists, Inc. (WS Comment #770); Begeny-Mahan (WS Comment
                1702) (stating that the eight-hour period is a problem because the
                office is closed on Wednesdays); Huynh (WS Comment #1940); Dhaliwal
                (WS Comment #2684); American Society of Cataract and Refractive
                Surgery (WS Comment #3142); Morales (WS Comment #3404); Yu-Davis (WS
                Comment #3410), Rhee (WS Comment #3468); Meyers (NPRM Comment #173);
                Pierce (NPRM Comment #187) (estimating that the office spends
                approximately twelve minutes responding to a verification request);
                Kempf (NPRM Comment #915) (stating that the office is closed on
                Wednesdays and incorrect prescriptions received late on Tuesday will
                be filled); Goodman (NPRM Comment #1340) (stating that the
                prescriber is unable to respond to requests within the eight-hour
                period because the office is closed on Mondays); Speiser (NPRM
                Comment #2233) (stating that eight hours are not enough time because
                the doctor spends time at the hospital and is not in the office
                every day); Weingeist (NPRM Comment #2496) (stating that the
                practice is small and the requests are burdensome); American Society
                of Cataract and Refractive Surgery (NPRM Comment #3820); McPherson
                (NPRM Comment #3397) (stating that the office is very busy with
                patients and verification requests can be forgotten).
                ---------------------------------------------------------------------------
                 The Commission considered these comments and, for the reasons
                stated in the NPRM, declines to change the eight-business-hour period,
                including by lengthening the period or changing how the period is
                calculated. Congress mandated the verification system and that a
                prescriber respond within ``8 business hours, or a similar time as
                defined by the Federal Trade Commission.'' \386\ In determining this
                time period, Congress balanced the harm to consumers if they were
                unduly delayed in receiving their contact lenses against the harm from
                receiving contact lenses based on an invalid prescription.\387\ The
                Commission does not find any compelling changes to the marketplace
                since the Rule's promulgation in 2004 that support extending the eight
                business hour period.\388\
                ---------------------------------------------------------------------------
                 \386\ NPRM, 81 FR at 88544. Some prescribers or sellers may be
                confused about when the eight-business-hour period starts following
                a verification request and the applicable time zone. See, e.g.,
                Goodman (WS Comment #599); Palmer (WS Comment #2215); Wang (WS
                Comment #3448); Gilberg (NPRM Comment #198); Huff (NPRM Comment
                #1964); Osterholzer (NPRM Comment #2085) (stating that the office is
                not open during the same hours as the seller and in a different time
                zone). Under the Rule, when a request is received after 5 p.m., the
                eight-business- hour period would not start until 9 a.m. the next
                weekday that is not a federal holiday, or if applicable, on Saturday
                at the beginning of the prescriber's actual business hours. A
                business hour is determined based on the time zone of the
                prescriber. 16 CFR 315.2, 315.5.
                 \387\ NPRM, 81 FR at 88544.
                 \388\ The Commission recognizes a need for clarification with
                respect to whether a seller can ship lenses to a consumer after
                receiving notification from a prescriber that the submitted
                prescription is inaccurate, invalid, or expired but when such
                notification occurs after the eight-business-hour period has passed.
                In its initial rulemaking, the Commission declined to expressly
                prohibit sellers from shipping lenses in such an instance, but noted
                that nothing in the Rule prohibits a prescriber from submitting late
                notifications to the seller or the seller from acting upon them, and
                that it would likely be in the best interest of their mutual
                consumer for them to do so. Contact Lens Rule, 69 FR 40050. However,
                the Commission is aware that the marketplace for contact lens sales
                now includes subscription models, in which sellers provide a
                quantity of lenses to consumers, not in a single-delivery supply,
                but rather in periodic installments (usually every month, although
                sometimes quarterly or semi-annually). In such a circumstance, the
                seller would have plenty of time to halt a subsequent installment
                shipment after being informed that the consumer's prescription was
                invalid, inaccurate, or expired. Therefore, the Commission clarifies
                that while the Rule does not prohibit an initial shipment to a
                consumer in instances where the seller received such notification
                after the eight-business-hour period has passed, any subsequent
                shipments based on the initial verification request would violate
                the Rule. A seller who has been notified that the patient does not
                have a valid prescription cannot ignore such notification and
                continue to sell and ship lenses every month simply because the
                notification came in after the eight-business-hour deadline.
                ---------------------------------------------------------------------------
                [[Page 50696]]
                VI. Seller Alteration of Contact Lens Prescriptions and Private Label
                Concerns
                 The current Rule states that a ``seller may not alter a contact
                lens prescription.'' The only exception applies to private label
                contact lenses and allows the seller, when a patient has a prescription
                for private label contact lenses, to substitute identical contact
                lenses that the same company manufactures and sells under a different
                name.\389\
                ---------------------------------------------------------------------------
                 \389\ 16 CFR 315.5(e).
                ---------------------------------------------------------------------------
                 In the SNPRM, the Commission expressed its concern about the
                emergence of sellers' business models that rely exclusively on passive
                verification as a means to substitute their own brand of contact lenses
                for the prescribed lens.\390\ As noted in the SNPRM, many prescribers
                detailed harm that resulted from wearing unprescribed lenses, such as
                headaches, corneal neovascularization, corneal ulcers, and other
                irreversible and vision-threatening diagnoses.\391\ As a result, the
                Commission proposed two modifications to the Rule.
                ---------------------------------------------------------------------------
                 \390\ SNPRM, 84 FR at 24687-88.
                 \391\ Id. at 24686.
                ---------------------------------------------------------------------------
                 The first modification proposed in the SNPRM, adding a paragraph
                (g) to Sec. 315.5, would require sellers to provide a clear and
                prominent method for the patient to present the seller with a copy of
                the patient's prescription. Such method might include, without
                limitation, electronic mail, text message, file upload, or facsimile.
                The Commission stated that this proposal would address prescriber and
                manufacturer concerns by increasing the number of patients who present
                online sellers with their prescriptions rather than relying on
                verification.\392\
                ---------------------------------------------------------------------------
                 \392\ Id. at 24688.
                ---------------------------------------------------------------------------
                 The second modification proposed in the SNPRM targeted concerns
                about prescription verification more directly. The proposed
                modification of Sec. 315.5(f) would define alteration to include a
                seller's providing, as part of a verification request, a prescriber
                with a manufacturer or brand other than that specified on a patient's
                prescription. The proposal included an exception, however, for sellers
                when they provide a manufacturer or brand that a patient provided to
                the seller, either on the order form or orally in response to a request
                for the manufacturer or brand listed on the prescription. In other
                words, to avail themselves of the exception, sellers must ask consumers
                to provide the manufacturer or brand listed on their prescription. The
                SNPRM further provided that a seller would not be able to avail itself
                of the exception by relying on a prepopulated or preselected box, or on
                consumers' online searches for a particular manufacturer or brand, as
                an indication that they were prescribed that manufacturer or
                brand.\393\ A seller not covered under the exception discussed above
                who made a verification request containing a manufacturer or brand
                other than, and not identical to, the one written on the consumer's
                prescription by their prescriber, would violate the Rule, even if a
                prescriber subsequently invalidated the request and the lenses were
                never sold.\394\
                ---------------------------------------------------------------------------
                 \393\ Id. at 24689.
                 \394\ Id.
                ---------------------------------------------------------------------------
                A. The Final Rule Includes a Requirement for Sellers To Accept
                Prescription Presentation
                 Commenters who discussed the Commission's proposal to require
                sellers to provide a clear and prominent method to present
                prescriptions were unanimous in their support, although some suggested
                revisions that they believed would make it more effective.\395\ A
                number of commenters asserted that this amendment would help decrease
                the number of verification requests \396\ and eliminate errors stemming
                from incorrect verification requests.\397\ In addition, the NAOO
                pointed out that such presentation benefits the consumer and the seller
                by reducing the time needed to fill the order and providing additional
                assurance of the prescription's validity.\398\ 1-800 CONTACTS also
                supported--and says that it already complies with--the prescription
                presentation proposal.\399\ Simple Contacts commented that the proposed
                requirement is fair, and opined that ``any seller who does not support
                prescription presentation has not made a good faith attempt to
                accurately verify all patient prescriptions.'' \400\ Simple Contacts,
                however, expressed skepticism that the amendment would significantly
                reduce the number of alterations by sellers abusing the passive
                verification system.\401\
                ---------------------------------------------------------------------------
                 \395\ Simple Contacts (SNPRM Comment #87); American Optometric
                Association (SNPRM Comment #96); Health Care Alliance for Patient
                Safety (SNPRM Comment #128); National Association of Optometrists
                and Opticians (SNPRM Comment #129); 1-800 CONTACTS (SNPRM Comment
                #135); Johnson & Johnson Vision Care, Inc. (SNPRM Comment #151).
                 \396\ Health Care Alliance for Patient Safety (SNPRM Comment
                #128); National Association of Optometrists and Opticians (SNPRM
                Comment #129); Johnson & Johnson Vision Care, Inc. (SNPRM Comment
                #151).
                 \397\ Health Care Alliance for Patient Safety (SNPRM Comment
                #128); National Association of Optometrists and Opticians (SNPRM
                Comment #129); 1-800 CONTACTS (SNPRM Comment #135); Johnson &
                Johnson Vision Care, Inc. (SNPRM Comment #151).
                 \398\ National Association of Optometrists and Opticians (SNPRM
                Comment #129).
                 \399\ 1-800 CONTACTS (SNPRM Comment #135).
                 \400\ Simple Contacts (SNPRM Comment #87). See also National
                Association of Optometrists and Opticians (SNPRM Comment #129)
                (``Contact lens sellers that do not provide a method to upload the
                prescription may be trying to avoid getting the patient's specific
                brand information, so that they can switch the patient into a
                different proprietary brand.'').
                 \401\ Simple Contacts (SNPRM Comment #87). The Health Care
                Alliance for Patient Safety stated that ``it is unclear whether the
                proposed amendment would have any effect on the incidence of
                alteration[s]'' since the Commission is not also prohibiting calls
                containing automated verification messages. SNPRM Comment #128.
                ---------------------------------------------------------------------------
                 Because the Commission did not receive any comments opposing this
                proposal, the Commission is incorporating the requirement in its Final
                Rule. The Commission believes the proposal will help reduce the number
                of verifications, reduce errors associated with incorrect verification
                attempts, and make it more difficult for ill-intentioned sellers to
                abuse the passive verification framework and take advantage of
                consumers who might not realize that the seller intends to verify a
                different lens than the one written on their prescription.
                 In the Final Rule, the Commission has changed the ``clear and
                prominent'' requirement to pertain to a disclosure of the method of
                prescription presentation (e.g., a disclosure that the method is
                available to provide the prescription). In so doing, the Commission
                makes clear that sellers cannot provide a method of prescription
                presentation without also providing a clear and prominent disclosure
                thereof.\402\ The Commission has retained the requirement that the
                method (e.g., email address, phone number to receive text messages, or
                upload link) be prominent.\403\ The Commission has also determined that
                it is unnecessary to include prescribers in this section of the Rule
                since it pertains to the ordering process between a seller and a
                consumer.\404\
                ---------------------------------------------------------------------------
                 \402\ For telephone orders, sellers would comply by making a
                prominent method available and giving clear and prominent notice of
                the method.
                 \403\ The Commission finds its proposed SNPRM requirement that
                the method be clear unnecessary given the new language requiring the
                disclosure of the method to be clear and prominent.
                 \404\ The Rule anticipates prescription presentation by
                prescribers to sellers. Section 315.5(a)(1) indicates that one way
                sellers can sell contact lenses is if they receive a prescription
                from a prescriber directly or by facsimile. 16 CFR 315.5(a)(1).
                ---------------------------------------------------------------------------
                 Commenters suggested three additional requirements for the
                prescription presentation proposal. First, the NAOO suggested the
                [[Page 50697]]
                Commission require that the method to present prescriptions be in close
                proximity to the option to provide the parameters of the contact lens
                for verification, so as to increase the likelihood that consumers would
                understand they have a choice between providing a prescription or
                having one verified with their prescriber.\405\ As drafted, the
                language did not specify at what point in the process a seller must
                make the method for prescription presentation available. The Commission
                believes that the NAOO's suggestion of close proximity would be
                helpful, but notes that if the method, and a disclosure thereof, are
                provided in close proximity but after the collection of all information
                required for verification is provided, the prescription presentation
                benefit may be diminished. In other words, if a consumer enters all the
                information required for verification (contact lens brand, powers,
                prescriber name and phone number) before learning about prescription
                presentation, and having an opportunity to present the prescription,
                the consumer may choose not to also provide the prescription. As a
                result, the Commission is amending the language of Sec. 315.5(g) in
                the Final Rule to require that the method and the disclosure of the
                method for the patient to present the seller with a copy of the
                patient's prescription must be prior to requesting a prescriber's
                contact information, which is necessary to verify a contact lens
                prescription.\406\
                ---------------------------------------------------------------------------
                 \405\ National Association of Optometrists and Opticians (SNPRM
                Comment #129).
                 \406\ In the case of orders placed by telephone, the Rule
                requires sellers to provide clear and prominent disclosure of the
                method for prescription presentation (e.g., a seller's email
                address) prior to requesting a prescriber's contact information.
                ---------------------------------------------------------------------------
                 Two commenters opined on whether consumers should be able to choose
                the method for providing their prescriptions. Consumer Reports stated
                its belief that, when offering prescription presentation, sellers
                should be required to provide consumers all four methods listed in the
                proposed Rule--electronic mail, text message, file upload, and
                facsimile--in lieu of giving sellers the option to choose from those
                methods.\407\ It indicated that requiring all four would not burden the
                seller, and there may be reasons that patients prefer one option over
                the others.\408\ On the other hand, the NAOO supported the Commission's
                proposal to let the seller decide the method.\409\ The Commission has
                decided to require sellers to offer prescription presentation by the
                same medium through which the order is placed, or by electronic mail,
                text message, or file upload.\410\ When orders are placed via
                telephone, sellers are required to offer prescription presentation via
                electronic mail, text message, or file upload. Because faxes are not
                commonly used by consumers, sellers can offer fax presentation as the
                sole option only when the orders are placed by fax. This framework
                gives consumers and prescribers an opportunity to present
                prescriptions, while limiting the burden on sellers, some of whom are
                small.\411\ The Commission believes that these changes from the SNPRM
                proposal are not significant, are consistent with the stated purpose of
                the proposal as outlined in the SNPRM,\412\ and will help ensure the
                maximum benefit from the Rule change.
                ---------------------------------------------------------------------------
                 \407\ Consumer Reports (SNPRM Comment #133).
                 \408\ Id.
                 \409\ National Association of Optometrists and Opticians (SNPRM
                Comment #129).
                 \410\ A seller who chooses to offer all methods will likely
                benefit by having more consumers provide prescriptions than if it
                offered only one or even two methods. Benefits to sellers from
                having prescriptions on file include avoiding the costs involved in
                verification, and having the ability to provide contact lenses more
                quickly than relying on verification.
                 \411\ For all orders, sellers can meet the requirement by
                accepting prescriptions via email. There should not be a significant
                burden on business to obtain and maintain an email address and
                process and store prescriptions received through email.
                 \412\ SNPRM, 84 FR at 24688-89.
                ---------------------------------------------------------------------------
                 Consumer Reports also recommended that sellers be required not just
                to accept prescription presentation, but also to specifically request
                and encourage patients to provide prescriptions.\413\ The Commission
                declines to adopt this suggestion. The Commission's Final Rule requires
                sellers to accept prescriptions. The Final Rule also requires that
                sellers clearly and prominently disclose how consumers can provide them
                with prescriptions. Sellers that more overtly request or encourage the
                submission of prescriptions (e.g., through price cuts and faster
                delivery times) will likely further increase the number of
                prescriptions presented, allowing both sellers and consumers to reap
                the benefits. However, the Commission has determined that beyond
                providing a method for consumers to present their prescriptions and
                notice of such method prior to requesting their prescriber's contact
                information, sellers should have discretion whether to promote or
                incentivize that practice.
                ---------------------------------------------------------------------------
                 \413\ Consumer Reports (SNPRM Comment #133).
                ---------------------------------------------------------------------------
                B. Alteration Includes a Seller Providing a Prescriber With a
                Verification Request for a Non-Prescribed Manufacturer or Brand, but
                Includes an Exception for Verifying a Manufacturer or Brand That a
                Consumer Indicates Is on Her Prescription
                 In the SNPRM, the Commission proposed a modification of Sec.
                315.5(f) to define alteration to include a seller's providing, as part
                of a verification request, a prescriber with a manufacturer or brand
                other than that specified on a patient's prescription. The proposal
                included an exception, however, for sellers when they provide in a
                verification request a manufacturer or brand that a patient provided to
                the seller, either on the order form or orally in response to a request
                for the manufacturer or brand listed on the prescription.\414\ As
                discussed below, in the Final Rule, the Commission has determined to
                adopt this definition of alteration along with a modified version of
                the accompanying exception.
                ---------------------------------------------------------------------------
                 \414\ SNPRM, 84 FR at 24698.
                ---------------------------------------------------------------------------
                1. The Final Rule Modifications Regarding Alteration Are Beneficial and
                Address Abuses of the Verification System
                 1-800 CONTACTS expressed its belief that the proposed alteration
                modification was unnecessary and requested that the Commission
                carefully evaluate any new regulations that could interfere with the
                convenience and competitive pricing of legitimate sellers.\415\
                Although the seller recognized the presence of single-brand sellers in
                the market, and the problems some cause, 1-800 CONTACTS stated that the
                addition of quality standards for verification calls, along with
                targeted enforcement against sellers with a business model based solely
                on noncompliant verification methods, would reduce the ability of these
                sellers to profit from abusing the passive verification system.\416\
                Specifically, it felt that ``enforcement against one such business [ ]
                would likely be sufficient to chill or completely eliminate replication
                of this business model.'' \417\ The Commission agrees that the
                requirement to provide a method for prescription presentation, and a
                disclosure thereof, should reduce the number of verification requests,
                and that the addition of quality standards for verification calls
                should reduce the incidence of non-compliant verification calls and
                increase the ability of prescribers to deny invalid requests or
                [[Page 50698]]
                correct inaccurate ones. However, based on comments from prescribers as
                well as its own investigations and experience, the Commission believes
                those amendments on their own are inadequate to curb the practice of
                substitution to non-prescribed brands through abuse of the verification
                system. The Commission has previously stated that, under the existing
                Rule, a verification request is not valid and does not commence the
                eight-business-hour verification period if a seller knows or should
                know that the verification request includes a different brand and
                manufacturer than that prescribed.\418\ Any sales after such requests
                violate the Rule, even if a prescriber has not responded. In these
                instances, the seller is not selling in accordance with a prescription.
                Despite clearly articulating this position, the FTC continues to
                receive reports about the proliferation of passive verification abuses.
                Furthermore, sellers may argue that they are technically compliant with
                the Rule because they submitted verification requests and prescribers
                had an opportunity to respond to the requests. They may also argue that
                they did not have knowledge that a consumer did not have a prescription
                for that manufacturer or brand of lens.
                ---------------------------------------------------------------------------
                 \415\ 1-800 CONTACTS (SNPRM Comment #135).
                 \416\ Id.
                 \417\ Id.
                 \418\ SNPRM, 84 FR at 24687-88.
                ---------------------------------------------------------------------------
                 Additionally, this is not an issue of one bad actor. As noted in
                the SNPRM, the Commission has seen the emergence of businesses that
                rely exclusively, or almost exclusively, on passive verification as a
                means to substitute their own brand of contact lenses.\419\ Simple
                Contacts' comment notes that, within the last two years, several new
                companies have entered the U.S. market and that their abuse of the
                verification system appears willful.\420\ The AOA similarly noted an
                increase of direct-to-consumer brands and named three new market
                entrants that reportedly replace their own brand of lenses for the
                prescribed brand.\421\ The Commission therefore sees benefits to
                defining alteration to include a seller's providing a prescriber, as
                part of a verification request, with a manufacturer or brand other than
                that specified on a patient's prescription.
                ---------------------------------------------------------------------------
                 \419\ SNPRM, 84 FR at 24687.
                 \420\ Simple Contacts (SNRPM Comment #87).
                 \421\ American Optometric Association (SNPRM Comment #96).
                ---------------------------------------------------------------------------
                2. Comments Related to the Exception to Alteration When a Seller
                Provides the Manufacturer or Brand of Lenses That a Consumer Provides
                in Response to a Seller's Request for That Information
                 The SNPRM proposed that sellers receive an exception from
                alteration when they provide, in a verification request, a manufacturer
                or brand that a patient provided to them, either on the order form or
                orally in response to a request for the manufacturer or brand listed on
                the prescription.\422\ If the seller seeks to verify a manufacturer or
                brand other than that indicated by the consumer, even if a prescriber
                ultimately denies the request, the seller has committed a violation.
                The implementation of the alteration definition, including the
                exception, should serve as an effective deterrent against sellers that
                try to game the verification system to sell non-prescribed contact
                lenses.
                ---------------------------------------------------------------------------
                 \422\ SNPRM, 84 FR at 24686.
                ---------------------------------------------------------------------------
                 In response to the SNPRM, commenters expressed concerns that some
                sellers might take advantage of the exception by inducing, suggesting,
                advertising, or otherwise causing consumers to provide a name other
                than that on their prescription so as to allow the seller to seek
                verification of a brand that had not been prescribed for the
                consumer.\423\ The NAOO was specifically concerned that ``less
                scrupulous sellers'' would attempt to take advantage of this exception,
                and noted that currently some sellers only request the power of the
                lenses from the customer and then ask prescribers to verify a
                prescription with a private label brand.\424\ Commenters proffered
                different recommendations as to how to address this issue. CooperVision
                requested that the Commission state in a guidance document that sellers
                cannot induce, suggest, advertise, or otherwise cause patients to
                provide the wrong name, and to provide examples of improper
                statements.\425\ Johnson & Johnson Vision Care suggested that, should
                the Commission retain the exception, it should add the following
                clarifying language to the preamble section of the Rule: ``This
                exception is intended to provide explicit direction for sellers as to
                when they are responsible for instances of prescription alteration.
                Under no circumstances may a seller, wishing to avail themselves of
                this exception, direct, encourage, motivate, or suggest, either
                implicitly or explicitly, that a patient enter any manufacturer or
                brand other than that listed on the patient's prescription.'' \426\ The
                NAOO recommended that the Rule itself be further amended to provide
                more specific direction as to what the seller must, may, and cannot do
                when asking patients for the information the FCLCA requires in a
                verification request. Specifically, it recommended adding a requirement
                that to avail itself of the exception, a seller must have had no reason
                to believe that the name provided by the consumer was not the
                manufacturer or brand listed on that consumer's prescription.\427\
                ---------------------------------------------------------------------------
                 \423\ National Association of Optometrists and Opticians (SNPRM
                Comment #129); CooperVision, Inc. (SNPRM Comment #130); Johnson &
                Johnson Vision Care, Inc. (SNPRM Comment #151).
                 \424\ National Association of Optometrists and Opticians (SNPRM
                Comment #129).
                 \425\ CooperVision, Inc. (SNPRM Comment #130).
                 \426\ Johnson & Johnson Vision Care recognized that the
                exception could serve as guidance for sellers to determine whether
                they are responsible for an illegal prescription alteration.
                However, it believes the exception should not be added to the Rule
                because a patient may not be able to correctly enter their
                information given the nuances of a contact lens prescription and the
                meaning of the different elements therein. Ultimately, Johnson &
                Johnson Vision Care is concerned that the exception may contribute
                to passive verification of an inaccurate prescription, and thus,
                illegal substitution. SNPRM Comment #151. The Commission does not
                believe that this concern is relevant to the exception, which
                relates to a consumer only providing her manufacturer or brand.
                 \427\ National Association of Optometrists and Opticians (SNPRM
                Comment #129).
                ---------------------------------------------------------------------------
                 The Commission agrees that sellers must not induce, suggest,
                advertise, or otherwise lead consumers to provide a manufacturer or
                brand different from that listed on their prescriptions. The Commission
                believes, however, that the recommended change is unnecessary because,
                should a seller attempt to induce or trick the consumer into providing
                the seller with a manufacturer or brand different from that listed on
                the consumer's prescription, it would not be able to avail itself of
                the exception. Any such conduct by the seller would call into question
                whether the consumer had provided the seller with the manufacturer or
                brand listed on her prescription in response to a clear request for
                such information, as required by the Rule.
                 Commenters expressed concern that the exception for patient
                prescription entry would allow consumers to override their
                prescriptions by providing a manufacturer or brand of contact lenses
                other than that prescribed to them by their prescriber.\428\ Similarly,
                one commenter stated that sellers should ensure that consumers
                understand that they need to request the lens specified on their
                prescription and, if consumers want a different lens,
                [[Page 50699]]
                sellers shall state prominently that consumers must discuss the request
                with, and make the change through, their prescribers.\429\ The concern
                that this amendment gives consumers permission to override their
                prescriptions, including choosing a new brand, is unfounded. The
                exception in no way gives consumers the ability to override
                prescribers' prescriptions, and it does not change the prescriber's
                ability to inform a seller that the prescription submitted for
                verification is inaccurate, expired, or otherwise invalid.\430\ In
                fact, by requiring sellers to ask consumers their manufacturer or brand
                to meet the exception, the proposal is encouraging just the opposite--
                inviting consumers to choose the brand prescribed for them. And, once
                the seller receives a communication from the prescriber that the
                prescription is invalid, it cannot sell the lenses without violating
                the Rule. The Commission therefore does not see a need to require
                sellers to inform consumers that if they want a different lens, they
                must go to their prescribers. Asking consumers for the manufacturer or
                brand listed on their prescriptions, and clarifying that sellers may
                not induce, suggest, or otherwise cause consumers to select or provide
                a manufacturer or brand other than that prescribed, should be adequate
                to curtail much of the illegal alterations occurring through abuse of
                the verification system. Moreover, the Commission has issued consumer
                notices that indicate that if consumers wish to switch their brand of
                lens, they need to contact their prescribers.\431\ The Commission will
                continue its educational efforts in this area.
                ---------------------------------------------------------------------------
                 \428\ American Optometric Association (SNPRM Comment #96);
                Health Care Alliance for Patient Safety (SNPRM Comment #128).
                 \429\ CooperVision, Inc. (SNPRM Comment #130).
                 \430\ Final Rule 16 CFR 315.5(e). Despite this prohibition,
                substitution to another brand of lenses was always a risk with
                passive verification, but it was a risk Congress considered before
                instituting the verification framework set forth in the Act. See,
                e.g., FCLCA Subcomm. Hearing, supra note 17 (statements of Howard
                Beales, Federal Trade Commission); id. (statements of J. Pat
                Cummings, American Optometric Association) (``And the problem with
                passive verification is that people will get contact lenses without
                a prescription.'').
                 \431\ See, e.g., Federal Trade Commission, Prescription Glasses
                and Contact Lenses, https://www.consumer.ftc.gov/articles/0116-prescription-glasses-and-contact-lenses (last visited Nov. 19,
                2019).
                ---------------------------------------------------------------------------
                3. Comments Regarding and Commission Guidance on Acceptable Methods for
                Obtaining the Brand or Manufacturer Listed on Consumers' Prescriptions
                 1-800 CONTACTS expressed concern that the Commission's amendment
                might interfere with its ability to improve the user experience. It
                indicated that it sells hundreds of brands of lenses and offers
                consumers a variety of methods to identify their brand, including drop-
                down menus, a search box, and filters that display lenses by brand,
                modality, and other parameters and that some consumers do not enter
                their brand information on an order form.\432\
                ---------------------------------------------------------------------------
                 \432\ 1-800 CONTACTS (SNPRM Comment #135).
                ---------------------------------------------------------------------------
                 Simple Contacts asked for greater specificity on the acceptable
                mechanisms for soliciting the contact lens brand or manufacturer, as a
                way to prevent bad actors from finding mechanisms to circumvent the
                intent of the Rule. Simple Contacts recommended limiting such
                mechanisms to five: Providing verbal confirmation of the brand or
                manufacturer; providing a copy of a prior prescription indicating the
                brand or manufacturer; typing a selection into a free entry text or
                search field; selecting a brand or manufacturer from a list or database
                containing the majority of commercially available brands (e.g., a drop-
                down menu), or providing a photo of a contact lens box.\433\
                ---------------------------------------------------------------------------
                 \433\ Simple Contacts (SNPRM Comment #87). The NAOO also stated
                that a seller should be able to rely on a customer-provided
                photograph of packaging of contact lenses for a current
                prescription. SNPRM Comment #129.
                ---------------------------------------------------------------------------
                 Johnson & Johnson Vision Care opined that should the Commission
                proceed with the exception, a seller should not be able to avail itself
                of the exception by relying on a prepopulated or preselected box, or on
                consumers' online searches for a particular brand or manufacturer, as a
                representation by consumers that they do, in fact, have a prescription
                for that brand or manufacturer. In contrast to the view expressed by 1-
                800 CONTACTS and Simple Contacts, Johnson & Johnson Vision Care
                requested the Commission prohibit drop-down menus and similar tools as
                methods by which a seller could avail itself of the exception.\434\
                ---------------------------------------------------------------------------
                 \434\ Johnson & Johnson Vision Care, Inc. (SNPRM Comment #151).
                ---------------------------------------------------------------------------
                 The Commission agrees that greater specificity surrounding
                acceptable methods would benefit sellers trying to comply with the
                Rule, but recognizes the myriad of ways consumers can interact with
                sellers to purchase lenses. Specifically, the Commission agrees that
                the requirement to provide the manufacturer or brand if not orally,
                then on an order form, imposes unnecessary limits for a consumer to
                select her manufacturer or brand. As a result, it is removing the term
                ``order form'' from the Final Rule. However, while sensitive to
                sellers' needs to create the best and most convenient consumer
                experience, the Commission believes requiring that they ask for the
                name of the manufacturer or brand listed on consumers' prescriptions
                can still be done while providing a positive purchasing experience for
                their customers.
                 At a minimum, in order for sellers to consider the consumer's
                indication of manufacturer or brand as adequate to qualify for the
                exception, the manufacturer or brand must be: (1) Provided in response
                to a seller's request for the manufacturer or brand listed on the
                consumer's prescription, and (2) an affirmative statement or selection
                by the consumer, not a preselected or prefilled entry (collectively
                ``the minimum criteria''). As to the first minimum criterion, a seller
                cannot assume that a consumer who searches on the internet for a
                specific manufacturer or brand of lens has a prescription for that
                manufacturer or brand of lens. Similarly, a consumer's selection next
                to a request for the manufacturer or brand the consumer wears or wishes
                to purchase would be insufficient because a consumer may be wearing or
                attempting to order a non-prescribed lens. In contrast, a seller can
                reasonably rely on a consumer's entry of a manufacturer or brand in
                response to a request for the ``manufacturer or brand listed on your
                prescription.'' The second minimum criterion for sellers to qualify for
                the exception is that they must elicit from the consumer an affirmative
                statement or selection of the manufacturer or brand. A seller that
                relies on a preselected, prechecked box stating ``I agree I have a
                prescription for this brand,'' or something similar, would not qualify
                for the exception to alteration. For telephone orders, the consumer
                must state the name of the manufacturer or brand in response to a
                seller's request for the manufacturer or brand listed on her
                prescription.\435\ A seller can rely on a consumer-provided photograph
                of a contact lens box or a copy of a prior prescription so long as the
                seller meets the two minimum criteria listed above and obtains
                additional information from the consumer or prescriber that the
                consumer has a current prescription for that brand.\436\
                ---------------------------------------------------------------------------
                 \435\ A seller receiving an affirmative response to its request
                ``Do you have a prescription for this brand?'' would be unable to
                meet the exception.
                 \436\ The information from the prescriber or consumer would
                provide the seller with a basis for the verification other than the
                expired prescription. See Section X.B., supra and NPRM, 81 FR at
                88546-67 (a seller may not use an expired prescription as the basis
                for a verification request).
                ---------------------------------------------------------------------------
                 The Commission is not limiting the permissible methods for
                obtaining
                [[Page 50700]]
                manufacturer or brand to meet the exception to only those discussed
                above. The Commission instead is leaving sellers the option of deriving
                other ways to elicit the prescribed manufacturer or brand, within the
                guidelines discussed in this section. The Commission also declines to
                add a preamble further explaining the ways for sellers to meet the
                exception, but instead relies on this notice as guidance.
                 1-800 CONTACTS opined that the Commission should not refer to
                ``brand'' in the amendment to the Rule as that language does not appear
                elsewhere in the Rule. It points out that the Rule defines a
                prescription as including a ``material or manufacturer or both'' and
                that the Commission's inclusion of the reference to brand imposes an
                additional limit on consumer choice that the Act does not require. 1-
                800 CONTACTS requested instead that the exception to the Rule be
                applicable to ``providing the prescriber with the name of a
                manufacturer or material other than that specified by the patient's
                prescriber . . . .'' The reference to brand in the definition of
                alteration and in the exception would indeed be the only references to
                brand in the Rule. However, in practice, it appears many, if not most,
                prescriptions list the manufacturer's brand, not the manufacturer or
                material, and the brand is viewed as shorthand for the entire
                device.\437\ Furthermore, very few consumers know the manufacturer or
                material of contact lens that they wear, and typically refer to their
                lenses by brand name. Amending the exception in the way 1-800 CONTACTS
                recommended would be unworkable since many consumers would be unable to
                provide the manufacturer or material in response to a seller's request,
                and might even have to ask their prescribers. Should prescribers'
                practices change from listing a brand on a prescription to listing a
                manufacturer or material, the Commission will reevaluate its decision.
                ---------------------------------------------------------------------------
                 \437\ SNPRM, 84 FR at 24686 n.299. See also National Association
                of Optometrists and Opticians (SNPRM Comment #129) (noting as an
                example that many, if not most, prescriptions for My Day lenses
                manufactured by CooperVision get written as ``My Day,'' not as
                ``CooperVision'' or ``CooperVision My Day'').
                ---------------------------------------------------------------------------
                4. The Commission Is Not Imposing a Recordkeeping Requirement for
                Sellers Related to the Exception
                 Lastly, CooperVision strongly recommended that the Commission
                reconsider its decision not to require sellers to keep records related
                to the exception and noted that the Rule relies heavily on requiring
                written evidence. CooperVision claimed that the lack of a recordkeeping
                requirement would leave a gap that could be exploited, and would make
                it difficult for the Commission to pursue enforcement against sellers
                who violate the Rule.\438\ The Commission disagrees with this
                assessment. Since the exception to alteration would be a defense for a
                seller, the seller would have the burden of proof to show it met the
                exception. Should the Commission believe that the seller has altered a
                contact lens prescription and submitted a verification request for a
                manufacturer or brand other than that indicated by a consumer, the
                seller would need evidence that it meets the exception. Sellers who
                determine not to maintain records do so at their own peril.
                ---------------------------------------------------------------------------
                 \438\ CooperVision, Inc. (SNPRM Comment #130).
                ---------------------------------------------------------------------------
                C. Private Label Issues
                 Although most contact lenses in the United States are sold under
                national brand names (such as Acuvue Oasys, or Dailies Aquacomfort
                Plus), some manufacturers distribute their lenses to prescribers and
                retail sellers under private labels (such as Costco's Kirkland
                Signature contact lens brand or LensCrafters 1-Day Premium contact
                lenses). Private label contact lenses can be unique to one seller, or
                the private label brand may be available at multiple unaffiliated
                sellers.\439\ Despite the label, however, the lenses inside the
                packaging are exactly the same as lenses sold under a national
                brand.\440\
                ---------------------------------------------------------------------------
                 \439\ 2005 Contact Lens Report, supra note 14, at 14-15.
                 \440\ For example, Costco's Kirkland Signature Premium Daily
                Disposable lenses are the same as CooperVision MyDay disposable
                lenses.
                ---------------------------------------------------------------------------
                1. The Commission Adopts a Technical Amendment and Clarifies That the
                Only Permissible Substitution Involves Private Label Lenses
                 In Sec. 315.2, the Rule defines private label lenses as ``contact
                lenses that are sold under the label of a seller where the contact
                lenses are identical to lenses made by the same manufacturer but sold
                under the labels of other sellers.'' \441\ The Rule also provides that
                a prescription for private label contact lenses must include, in
                addition to other required information, the name of the manufacturer,
                trade name of the private label brand, and if applicable, the trade
                name of equivalent brand name.\442\ The Rule's definition for a private
                label lens prescription tracks the language of the Act.\443\
                ---------------------------------------------------------------------------
                 \441\ 16 CFR 315.2.
                 \442\ Id.
                 \443\ See 15 U.S.C. 7610(3)(H).
                ---------------------------------------------------------------------------
                 With respect to how sellers treat and substitute private label
                lenses, however, the Commission recognized in the NPRM that the
                construction of Sec. 315.5(e) of the Rule does not presently conform
                to the language or intent of the Act.\444\ The clear language of the
                Act allows sellers to substitute national brand name lenses for private
                label lenses, and vice versa, so long as it is ``the same contact lens
                manufactured by the same company and sold under multiple labels to
                individual providers.'' \445\ The Rule, meanwhile, states that a seller
                may ``substitute for private label contact lenses specified on a
                prescription identical contact lenses that the same company
                manufactures and sells under different labels.'' \446\ The different
                language of the Act thus allows sellers to substitute brand names for
                identical private labels, and private labels for identical brand names,
                while the Rule, as currently drafted, could be read to proscribe the
                latter.
                ---------------------------------------------------------------------------
                 \444\ NPRM, 81 FR at 88552.
                 \445\ 15 U.S.C. 7603(f). Although the Commission imagines it
                would be quite rare, it believes a seller should be permitted under
                the Rule to substitute one private label lens for another private
                label lens so long as the lenses are identical.
                 \446\ 16 CFR 315.5(e).
                ---------------------------------------------------------------------------
                 To conform the Rule to the Act, the Commission proposed in the NPRM
                to strike the words ``private label'' from Sec. 315.5(e), so it would
                state that a seller may ``substitute for contact lenses specified on a
                prescription identical contact lenses that the same company
                manufactures and sells under different labels.'' \447\ The Rule's
                definitions of a ``contact lens prescription'' and of a ``private label
                contact lens'' would remain unchanged. The Commission made this
                proposal after becoming aware that, in addition to prescribers, some
                other sellers (such as Costco) now market and sell private label
                contact lenses that are identical to, and are made by the same
                manufacturer as, brand name contact lenses. As a result, when a patient
                presents a contact lens prescription for brand name contact lenses to
                certain sellers, those sellers may wish to sell, as a substitute, their
                own private label lenses to the patient.
                ---------------------------------------------------------------------------
                 \447\ NPRM, 81 FR at 88552.
                ---------------------------------------------------------------------------
                 While the Commission's proposal was intended to clarify the Rule
                and align it with the Act's intent, some commenters opposed the change
                because they believed it could be interpreted as allowing substitution
                beyond that of private label lenses.\448\ According to Johnson &
                Johnson Vision Care, the
                [[Page 50701]]
                ``private label'' modifier is necessary to provide guidance that the
                only instance in which a seller can lawfully substitute lenses for
                those written on a prescription is for identical private label lenses,
                and that removing the words ``private label'' from the command section
                of the Rule (leaving it only in the definitions section), will render
                the term meaningless.\449\ The removal of this term is especially
                problematic, according to the manufacturer, because illegal
                substitution is a problem in the marketplace, and it could ultimately
                cause undue, avoidable harm to patient eye health and vision
                safety.\450\ Should the Commission choose to proceed with its removal
                of the term ``private label'' from Sec. 315.5(e), Johnson & Johnson
                Vision Care requested that the Commission explicitly clarify that such
                removal does not allow for substitution beyond the scope of private
                label lenses or identical contact lenses that the same company
                manufactures and sells under different labels. It further suggested
                that the most appropriate and effective place to clarify how the
                Commission interprets this Rule provision would be in the preamble of
                the Rule, rather than the regulatory language itself.\451\
                ---------------------------------------------------------------------------
                 \448\ Johnson & Johnson Vision Care, Inc. (NPRM Comment #4327);
                see also Tesinsky (NPRM Comment #4012) (fearing change may be
                interpreted as the ``ability to substitute a different contact by
                the same manufacturer (for example substituting Acuvue Oasys for
                Acuvue Vita), rather than just a private label substitute'').
                 \449\ Johnson & Johnson Vision Care, Inc. (NPRM Comment #4327);
                see also American Optometric Association (NPRM Comment #3830)
                (opposing Commission's proposal and finding the term ``private
                label'' provides necessary clarity to ensure inappropriate
                substitutions do not occur).
                 \450\ Johnson & Johnson Vision Care, Inc. (NPRM Comment #4327).
                 \451\ Johnson & Johnson Vision Care, Inc. also supported its
                position that the clarification should be made in the preamble by
                reference to the fact that there were not specific reports of
                sellers encountering issues with the original Rule language. NPRM
                Comment #4327.
                ---------------------------------------------------------------------------
                 Costco, in contrast, supported the Commission's proposed change,
                because it would make clear that sellers can substitute their own
                private label contact lenses for prescribed lenses that are identical
                to lenses made by the same manufacturer and sold under the
                manufacturer's brand.\452\ Although Costco believes that the existing
                Rule allows it, when presented with a valid prescription for the
                manufacturer's brand, to substitute Kirkland Signature lenses, it
                believed that modifications to the language of Sec. 315.5(e) would
                clarify and eliminate any doubt about the lawfulness of this practice.
                Costco also opined that without such a change, the legality of such
                substitution might be in question, and, as a result, some sellers,
                particularly those without an established relationship with
                prescribers, would likely be unwilling to invest in a private label
                lens line.\453\ Consumers Union also supported the change, indicating
                that it increases the choices available to consumers, including
                potentially more affordable options, without in any way undermining
                patient safety.\454\
                ---------------------------------------------------------------------------
                 \452\ Costco Wholesale Corporation (NPRM Comment #4281).
                 \453\ Id. Costco also commented that bringing a private label
                lens to market can significantly benefit consumers in terms of
                introducing lower prices. NPRM Comment #4281.
                 \454\ Consumers Union (NPRM Comment #3969).
                ---------------------------------------------------------------------------
                 The Commission did not intend for the removal of the words
                ``private label'' in the Rule to make substitution more widely
                permissible beyond that of a seller being able to provide a private
                label lens when the identical lens (made by the same manufacturer but
                sold under a different label) is written on the prescription. However,
                in order to allay concerns, the Commission has retained the term
                ``private label,'' but reordered the provision to clarify that
                permissible substitution only involves private label contact lenses.
                Thus, the Final Rule allows private label and brand name lenses, when
                they are identical lenses made by the same manufacturer listed on the
                prescription, to be substituted for each other.\455\
                ---------------------------------------------------------------------------
                 \455\ Section 315.5(f) of the Final Rule reads:
                ``Notwithstanding the preceding sentences, for private label contact
                lenses, a seller may substitute for contact lenses specified on a
                prescription identical contact lenses that the same company
                manufactures and sells under different labels.'' The Commission
                revised the provision to refer to the ``preceding sentences'' to
                make it clear that the phrase beginning with ``[n]otwithstanding''
                does not apply to anything other than Sec. 315.5(f).
                ---------------------------------------------------------------------------
                2. The Commission Is Not Imposing Additional Requirements on
                Prescriptions for Private Label Lenses
                 As mentioned above, the Act and the Rule require prescriptions for
                private label contact lenses to include ``the name of the manufacturer,
                trade name of the private label brand, and if applicable, trade name of
                equivalent brand name.'' \456\ LD Vision Group (LensDiscounters.com),
                in response to the NPRM, provided the Commission with instances of
                alleged rule violations involving private label prescriptions
                improperly written or written without equivalents.\457\ It also
                requested that the Commission reconsider LD Vision Group's previous
                recommendations to: (1) Require prescribers to annotate private label
                lens prescriptions with the brand-name equivalent and if the name-brand
                equivalent is unavailable, the private-label prescription must be
                medically necessary for that particular patient; (2) require
                manufacturers of contact lenses to make brand information available to
                all sellers, consumers, and the FTC; or (3) require manufacturers and
                sellers to make brand equivalency information available and easily
                accessible for private labels on their brand label packaging and
                online.
                ---------------------------------------------------------------------------
                 \456\ 15 U.S.C. 7610; 16 CFR 315.2 (in definition of contact
                lens prescription).
                 \457\ This commenter also disagreed with what it stated was the
                ``Commission's diminishment of private label concerns.'' LD Vision
                Group, Inc. (NPRM Comment #3958).
                ---------------------------------------------------------------------------
                 Although the Commission appreciates the additional information
                provided by LD Vision Group, the information has not altered the fact,
                as stated in the SNPRM, that the Act does not impose a requirement of
                medical necessity in order for a prescriber to prescribe a private
                label lens for which no name-brand equivalent exists.\458\ The Act also
                does not expressly contemplate the imposition of disclosure
                requirements on manufacturers. Therefore, the Commission is not
                implementing the recommendations of LD Vision Group.
                ---------------------------------------------------------------------------
                 \458\ SNPRM, 81 FR 88551. In the SNPRM, the Commission also
                referenced the initial rulemaking, where sellers recommended that
                prescribers be required, when prescribing private label contact
                lenses, to identify on the prescription the name of a brand that a
                consumer could purchase from a seller other than the prescribing
                office. 69 FR 40503. The Act does not limit, in any way, the brand
                that a prescriber must select, and the current record does not have
                sufficient evidence indicating that this is a problem. Id.
                Therefore, LD Vision Group's proposal to limit prescribers from
                prescribing private label brands without a brand-equivalent is not
                adopted.
                ---------------------------------------------------------------------------
                 The Act and the Rule expressly require that, for private label
                contact lens prescriptions, prescribers include ``trade name of
                equivalent brand name.'' \459\ Prescribers violate the Rule if they
                provide a script that omits this information because the script does
                not meet the definition of a contact lens prescription. With that in
                mind and given the additional information provided by LD Vision Group,
                the Commission will consider whether enforcement action is appropriate.
                ---------------------------------------------------------------------------
                 \459\ 15 U.S.C. 7610, 16 CFR 315.2 (contact lens prescription
                defined to include, in the case of a private label contact lens, the
                name of the manufacturer, trade name of the private label brand,
                and, if applicable, trade name of equivalent brand name).
                ---------------------------------------------------------------------------
                VII. ``Directly or by Facsimile'' Language Includes Use of Online
                Patient Portals to Present Prescriptions
                 Section 315.5(a)(1) of the Rule provides that a seller may sell
                contact lenses in accordance with a prescription that is presented to
                the seller ``directly or by facsimile.'' In the NPRM, the Commission
                initially determined that the provision ``directly or by facsimile''
                includes the use of online patient portals by patients and prescribers
                to present contact lens prescriptions to
                [[Page 50702]]
                sellers.\460\ The Commission noted that use of a patient portal
                ``necessarily involves `an exact copy of the prescription within the
                scope of acceptable direct presentation mechanisms.' '' \461\ The
                Commission observed in the NPRM that technology had evolved since the
                Rule's implementation in 2004 and that patient portals offered several
                potential benefits, including reducing: The chance of an inaccurate or
                expired prescription being presented to a seller; the costs for
                prescribers, patients, and sellers by making it easier and more
                efficient for patients to share and present prescriptions; and the
                number of verification requests to prescribers.\462\ The Commission
                sought comments on whether the use of online portals complies with the
                Rule and requested information about whether the Commission should
                consider any other issues related to the presentation of prescriptions
                to sellers.
                ---------------------------------------------------------------------------
                 \460\ NPRM, 81 FR at 88537-38.
                 \461\ Id. at 88538.
                 \462\ Id.
                ---------------------------------------------------------------------------
                 Although the Commission received many comments indicating that
                patients are able to receive their prescriptions electronically,
                including through patient portals, and interact with their prescribers
                electronically,\463\ few comments addressed the use of portals to
                present prescriptions directly to sellers. Commenters agreed that such
                technology could offer benefits, including reducing the number of
                requests for verification and additional copies, and giving patients
                greater access to their prescriptions.\464\ However, it is unclear how
                often, if at all, prescribers send prescriptions to sellers through a
                portal. Use of portals to transmit prescriptions to sellers could face
                barriers, including technology issues between the parties caused by
                using different software and platforms, and privacy restrictions
                preventing sellers from accessing patients' portal accounts.\465\
                ---------------------------------------------------------------------------
                 \463\ See, e.g., Eklund (WS Comment #502); Reed (WS Comment
                #749); Gitchell (WS Comment #759); Andrews (WS Comment #1014);
                Carvell (WS Comment #1021); Cecil (WS Comment #1892); Kuryan (WS
                Comment #3472); Hopkins (NPRM Comment #184); Wilson (NPRM Comment
                #1310); Grove (NPRM Comment #1702); MacDonald (NPRM Comment #2118);
                Andrus (NPRM Comment #3345); American Academy of Ophthalmology (NPRM
                Comment #3657) (``For practices that utilize electronic medical
                record systems, patients can request a copy of their prescription
                and [be] issued one electronically.''); Coalition for Contact Lens
                Consumer Choice (SNPRM Comment #89).
                 \464\ National Association of Optometrists and Opticians (NPRM
                Comment #3851) (noting that the option to provide a prescription
                through a portal should be available because technology will
                continue to advance); 1-800 CONTACTS (NPRM Comment #3898); Costco
                Wholesale Corp. (NPRM Comment #4281) (supporting the FTC's
                determination regarding presentation of prescriptions directly or by
                facsimile for the reasons cited in the NPRM); NPRM, 81 FR at 88538
                (identifying the potential benefits of using a portal to present a
                prescription to a seller). Other commenters have expressed the
                potential benefits of portals or electronic health records
                generally. See, e.g., Information Technology & Innovation Foundation
                (SNPRM Comment #103); Opticians Association of Americas (WS Comment
                #482); Marshall (WS Comment #518) (suggesting the benefit of
                electronic medical records in allowing easier access to the
                prescription); McCarty (WS Comment #1898); CooperVision, Inc. (WS
                Comment #3077); Coalition for Contact Lens Consumer Choice (WS
                Comment #3239) (stating that new technologies like electronic health
                records have benefits for consumers).
                 \465\ Hill (WS Comment #1361); McCarty (WS Comment #1898); Shum
                (WS Comment #543) (stating that ``[t]he use of patient portals to
                send Rx would be unreliable due to inconsistent EHR [(electronic
                health records)] software and that some doctors do not have EHR'');
                National Hispanic Medical Association (SNPRM Comment #146) (stating
                that creating a portal to share prescription information could be a
                burden on prescribers and patients); 1-800 CONTACTS (NPRM Comment
                #3898) (stating that ``to the extent prescribers use portals to
                provide sellers with prescriptions, their portal should have the
                ability to send the prescription to the seller directly by email,
                text, or facsimile, and a seller should not be required to develop
                direct communication links to the portal''); CLR Panel V Tr., supra
                note 191, at 19-20.
                ---------------------------------------------------------------------------
                 The Act and Rule clearly envision and support the use of electronic
                means to provide prescriptions. Section 7601(a)(2) of the Act requires
                prescribers to ``provide or verify the contact lens prescription by
                electronic or other means'' to patients' agents.\466\ As discussed in
                the NPRM, it would be inconsistent for the Rule to permit prescribers
                to provide prescriptions electronically to patients, but not allow
                prescribers to provide a prescription electronically to a seller.\467\
                ---------------------------------------------------------------------------
                 \466\ 15 U.S.C. 7601(a)(2); 16 CFR 315.3(a)(2).
                 \467\ NPRM, 81 FR at 88538.
                ---------------------------------------------------------------------------
                 Use of electronic medical records has increased in the health field
                generally,\468\ and many prescribers already use electronic methods to
                communicate with patients, including through patient portals.\469\
                Given the potential benefits, prescribers and patients should have the
                option to present a prescription to sellers through a patient portal
                when this method is available. Therefore, the Commission affirms its
                initial determination that the ``directly or by facsimile'' language
                includes the use of online patient portals by patients and prescribers
                to present contact lens prescriptions to sellers.
                ---------------------------------------------------------------------------
                 \468\ One survey from 2017 found that 52% of individuals were
                offered online access to their medical records by a health provider
                or insurer, an increase from 42% in 2014. Of those patients who were
                offered online access, more than half actually viewed their online
                medical records at least once in the past year. U.S. Dep't of Health
                & Human Servs., The Office of the National Coordinator for Health
                Information Technology, ``Individuals' Use of Online Medical Records
                & Technology for Health Needs'' 1-2 (2018). Furthermore, in 2013,
                57% of prescriptions nationally were sent electronically from
                physicians to pharmacies, with the rate in some states over 80%.
                U.S. Dep't of Health & Human Servs., The Office of the National
                Coordinator for Health Information Technology, ``E-Prescribing
                Trends in the United States'' 8 (2014).
                 \469\ American Optometric Association (SNPRM Comment #96)
                (stating that approximately 47.5% of optometrists used electronic
                health records with a patient portal in their practice); National
                Association of Optometrists and Opticians (SNPRM Comment #129)
                (``Practice management systems and electronic health records (EHRs)
                with the capacity to allow patient portals, email, and text
                communication are easily available at reasonable prices to
                optometrists . . . .''); National Hispanic Medical Association
                (SNPRM Comment #146); 1-800 CONTACTS (NPRM Comment #3898). But see
                CLR Panel V Tr., supra note 191, at 17 (comment by a panelist that
                only 8% of his office's patients used the portal).
                ---------------------------------------------------------------------------
                VIII. Requests for an Additional Copy of a Prescription
                 In the SNPRM, the Commission proposed requiring that prescribers
                who receive requests for additional copies of prescriptions from
                patients or their agents respond within forty business hours.\470\ The
                Commission believed that the forty-business-hour requirement was
                necessary to ensure that patients or their agents could receive
                additional copies of their prescription in a timely manner while
                recognizing that a shorter time period was unnecessary because patients
                would have already received a copy of their prescription after the
                contact lens fittings were completed and sellers could always submit a
                verification request.\471\ Additionally, prescribers would be required
                to note in the patient's file the name of the requester and the date
                and time the prescription was provided. The Commission sought comment
                on whether prescribers should be required to respond within a certain
                time period, whether forty business hours was the appropriate time
                period, and what records, if any, prescribers should be required to
                keep to document the request and response.\472\
                ---------------------------------------------------------------------------
                 \470\ SNPRM, 84 FR at 24684.
                 \471\ Id.
                 \472\ Id.
                ---------------------------------------------------------------------------
                A. Benefits of an Additional Copy and the Time Period To Respond to a
                Request
                 The AOA contends that Congress did not intend for sellers to be
                given authorization to serve as the patient's agent.\473\ Rather, the
                AOA ``assume[s] that Congress implemented this provision to account for
                cases in which a family member or caregiver needed authorization to
                obtain a patient's
                [[Page 50703]]
                prescription.'' \474\ As noted in the NPRM, the Commission relied on
                the plain language of the Act and Rule to determine that sellers could
                serve as agents for patients,\475\ and the AOA does not point to any
                contrary evidence.\476\ Additionally, the AOA believes that no deadline
                to respond to requests for additional copies is necessary because
                prescribers take their responsibilities to their patients
                seriously.\477\
                ---------------------------------------------------------------------------
                 \473\ American Optometric Association (SNPRM Comment #96).
                 \474\ Id.
                 \475\ NPRM, 81 FR at 88536. In addition to sellers, the SNPRM
                noted that patients themselves could request an additional copy of
                the prescription. Although a commenter requested that the Commission
                modify the Rule to clarify that patients can request their own
                additional copy (National Association of Optometrists and Opticians
                (SNPRM Comment #129)), the Commission believes that the Rule's
                language is sufficient and declines to make such change. SNPRM, 84
                FR at 24684 n.259.
                 \476\ American Optometric Association (SNPRM Comment #96).
                 \477\ Id. The AOA also urged the Commission not to rely on 1-800
                CONTACTS data indicating that only 46% of its requests for an
                additional copy of a prescription received a response because 1-800
                CONTACTS may not have the patients' consent to act as an agent.
                Although the Commission considered the 1-800 CONTACTS data, the
                Commission did not rely solely on this information when issuing its
                proposed Rule. SNPRM, 84 FR at 24669.
                ---------------------------------------------------------------------------
                 Other commenters supported the Commission's proposal regarding
                requests for additional copies.\478\ Commenters noted that a deadline
                to respond would: (1) Make the process more predictable for patients
                and sellers, especially when involving a prescriber who has not
                responded to such requests in the past; \479\ (2) potentially reduce
                the number of verification requests, which would benefit prescribers,
                sellers, and patients; and (3) improve the accuracy of information
                provided to sellers ensuring that patients receive the correct
                lenses.\480\ In addition to anecdotal accounts of prescribers not
                responding to requests for additional copies, 1-800 CONTACTS commented
                that, in 2019 to date, it had received a response to approximately 52%
                of its requests for an additional copy with 82% of the responses being
                received within forty-eight hours of the request.\481\ This 2019 data
                is similar to 1-800 CONTACTS' 2016 data, which showed that 46% of the
                requests received a response and 90% of those responses were received
                within two days.\482\ In response, the AOA questions 1-800 CONTACTS'
                2016 data because patients, who gave consent through a prechecked box,
                may not have intended for 1-800 CONTACTS to act as their agent in
                requesting the prescription.\483\ The AOA posits that prescriber
                concern over patients' consent ``may have impacted responses to [1-800
                CONTACTS'] requests,'' but offers no evidence to support this
                argument.\484\ Likewise, the AOA did not provide any data showing the
                extent to which prescribers have responded to requests for additional
                copies. Given the potential benefits and the aforementioned data, the
                Commission does not believe it is sufficient to rely simply on the
                expectation that all prescribers would fulfill their responsibilities
                to their patients. Rather, the Commission believes that the Rule should
                be amended to add a deadline to respond to a request for an additional
                copy.
                ---------------------------------------------------------------------------
                 \478\ Citizen Outreach (SNPRM Comment #78); Lens.com (SNPRM
                Comment #85); Coalition for Contact Lens Consumer Choice (SNPRM
                Comment #89); Consumer Action (SNPRM Comment #101); Information
                Technology and Innovation Foundation (SNPRM Comment #103); National
                Association of Optometrists and Opticians (SNPRM Comment #129);
                Consumer Reports (SNPRM Comment #133); 1-800 CONTACTS (SNPRM Comment
                #135); American Academy of Ophthalmology (SNPRM Comment #136);
                Attorneys General of 27 States (SNPRM Comment #139).
                 \479\ Although not always the case, some sellers expressed
                difficulties with obtaining responses from prescribers. See National
                Association of Optometrists and Opticians (SNPRM Comment #129)
                (stating that at least one NAOO member reported receiving timely
                responses while other members found that it was ``difficult, if not
                impossible, to get any form of a timely response'').
                 \480\ Coalition for Contact Lens Consumer Choice (SNPRM Comment
                #89); National Association of Optometrists and Opticians (SNPRM
                Comment #129); Consumer Reports (SNPRM Comment #133); 1-800 CONTACTS
                (SNPRM Comment #135); Attorneys General of 27 States (SNPRM Comment
                #139); Contact Lens Association of Ophthalmologists (NPRM Comment
                #4259).
                 \481\ 1-800 CONTACTS (SNPRM Comment #135).
                 \482\ 1-800 CONTACTS (NPRM Comment #3898).
                 \483\ American Optometric Association (SNPRM Comment #96).
                 \484\ Id.
                ---------------------------------------------------------------------------
                 Although some commenters agreed that the Commission's proposed
                deadline of forty business hours was a reasonable length of time,\485\
                other commenters urged the Commission to use a shorter period, such as
                one business day \486\ or twenty-four business hours,\487\ because (1)
                patients would want a quicker response, (2) the longer time period
                could undercut a benefit of using a prescription--reducing the number
                of verification requests, and (3) prescribers could be confused between
                forty business hours for an additional copy request and eight business
                hours for a verification request.\488\ Additionally, the work involved
                for a prescriber's office to respond to a request would not increase
                with a shorter deadline.\489\ Although patients would benefit from a
                shorter response period, the Commission recognizes the additional
                stress on prescribers of having less time to respond, even if the work
                involved to complete a response remains the same. Because patients
                should have already received a copy of their prescription after the
                fitting,\490\ sellers can submit a verification request to complete the
                sale more quickly,\491\ and prescribers have an obligation to respond
                to a request for an additional copy, unlike a verification request, the
                Commission declines to make any further changes and will adopt the
                proposed forty-business-hour period.
                ---------------------------------------------------------------------------
                 \485\ Coalition for Contact Lens Consumer Choice (SNPRM Comment
                #89); American Optometric Association (SNPRM Comment #96) (noting
                that if a deadline were added, forty business hours would be
                reasonable); Information Technology and Innovation Foundation (SNPRM
                Comment #103); 1-800 CONTACTS (SNPRM Comment #135); American Academy
                of Ophthalmology (SNPRM Comment #136).
                 \486\ Consumer Reports (SNPRM Comment #133).
                 \487\ National Association of Optometrists and Opticians (SNPRM
                Comment #129) (supporting a shorter time limit, in part, because the
                burden of complying could be lower due to portal, text, or email
                use).
                 \488\ National Association of Optometrists and Opticians (SNPRM
                Comment #129); Consumer Reports (SNPRM Comment #133).
                 \489\ Consumer Reports (SNPRM Comment #133).
                 \490\ 16 CFR 315.3(a)(1).
                 \491\ 16 CFR 315.5(a)(2).
                ---------------------------------------------------------------------------
                B. Requirement To Maintain Records
                 Finally, as to what records, if any, a prescriber should be
                required to maintain regarding the request for an additional copy, the
                AOA believes that sellers, not prescribers, should shoulder this burden
                because sellers are ``leveraging the patient agent provision to obtain
                patient prescriptions.'' \492\ Records of the request and the response
                would allow the Commission to monitor compliance.\493\ However, the
                Commission does not believe requiring the requestor to maintain such
                information would be appropriate because the obligation under the Rule
                to respond to prescription requests rests with prescribers and they
                would be in the best position to maintain records.\494\ Importantly,
                the Rule allows ``any person designated to act on behalf of the
                patient[,]'' including the patients themselves, family members, or
                caregivers, to request a copy of a prescription, not just sellers.\495\
                A shift of the recordkeeping burden to any
                [[Page 50704]]
                designated agent making a request would not allow for effective
                monitoring because the Commission might need to obtain records from a
                wide variety of agents in order to determine whether a particular
                prescriber is complying with the Rule. Thus, the Commission declines to
                change the recordkeeping requirement.
                ---------------------------------------------------------------------------
                 \492\ American Optometric Association (SNPRM Comment #96).
                 \493\ The proposed Rule would mandate that prescribers make
                notations of the required information in their records, but would
                not require that they keep specific documentation. SNPRM, 84 FR at
                24698. However, prescribers could choose to keep documentation of
                the request and response if they preferred.
                 \494\ See also National Association of Optometrists and
                Opticians (SNPRM Comment #129) (``We believe it will be straight-
                forward and simple for the prescriber to keep a record of receiving
                the request for a copy and noting how and when the prescriber
                responded.'').
                 \495\ SNPRM, 84 FR at 24684 n.259, 24698.
                ---------------------------------------------------------------------------
                 In conclusion, the Commission adopts the changes proposed in the
                SNPRM to require that prescribers respond to requests for an additional
                copy of a prescription within forty business hours and note in the
                patient's record the name of the requestor and the date and time that
                the prescription was provided in response.
                IX. Excessive Quantity
                 In the NPRM, the Commission declined to make any changes regarding
                the number of lenses that a consumer can purchase with a
                prescription.\496\ Several commenters had expressed concerns that
                consumers were able to obtain more than a year's supply of contact
                lenses, often by purchasing more than a year's worth at one time or by
                refilling their prescription just before the expiration date.\497\
                However, the Commission determined that there was insufficient evidence
                on the record to support a limit on the maximum quantity of lenses that
                consumers can purchase prior to the prescription's expiration.\498\
                Although there was some evidence that patients purchased contact lenses
                just before their prescriptions expired, this evidence did not show
                that the quantity of lenses being purchased was excessive or that
                consumers were skipping eye exams.\499\ Furthermore, the Commission
                believed that a maximum quantity limit would be difficult to administer
                and could have a more significant negative effect on consumers who,
                instead of following the recommended replacement schedule, opt to wear
                their lenses longer until they see a prescriber.\500\
                ---------------------------------------------------------------------------
                 \496\ NPRM, 81 FR at 88549.
                 \497\ Id. at 88547-48.
                 \498\ Id. at 88548-49. The Commission also declined to modify
                the Rule to state that contact lens prescriptions are valid for an
                unlimited quantity of lenses regardless of any prescriber-imposed
                limitation. The Commission found no evidence that prescribers were
                using quantity limits to undercut the prescription length and
                recognized that some state laws or regulations mandated that
                quantity information be included on a prescription, or that a
                prescriber may choose to do so. NPRM, 81 FR at 88549-50. However,
                prescribers cannot use quantity limits as a way to frustrate the
                Rule's prescription expiration requirements. Id. at 88550.
                 \499\ Id.
                 \500\ Id.
                ---------------------------------------------------------------------------
                 In response to the NPRM, some commenters supported the Commission's
                decision not to impose quantity limits \501\ while others expressed
                concerns about the purchase of excessive quantities and advocated for
                limits.\502\ The commenters who support quantity limits are concerned
                that patients who purchase excessive quantities of lenses face
                increased health risks because they do not see their prescriber as
                often.\503\ Contrary to the Commission's position in the NPRM, they
                believe that there is evidence in the record that consumers are
                purchasing an excessive number of lenses close to the end of their
                prescription and that a quantity limit can be implemented.\504\ These
                commenters point to survey evidence by Johnson & Johnson Vision Care
                showing that consumers, in response to reminders that their
                prescriptions would be expiring soon, ordered more lenses.\505\
                ---------------------------------------------------------------------------
                 \501\ Coalition for Contact Lens Consumer Choice (NPRM Comment
                #3718); Consumer Action (NPRM Comment #3721); 1-800 CONTACTS (NPRM
                Comment #3898).
                 \502\ See, e.g., Contact Lens Institute (SNPRM Comment #79);
                Goodman (WS Comment 599); Hanen (WS Comment #712); Dillehay (WS
                Comment #822); Rosenblatt (WS Comment #841); Hooven (WS Comment
                #1366); Henry (WS Comment #2194); Robson (WS Comment #2210);
                Wiechmann (WS Comment #2823); Health Alliance for Patient Safety (WS
                Comment #3206); Alcon Laboratories, Inc. (WS Comment #3339);
                Ellenbecker (WS Comment #3353); Jeun (NPRM Comment #1774); Daza
                (NPRM Comment #2002); Silva (NPRM Comment #3072); CooperVision, Inc.
                (NPRM Comment #3841); Coalition for Patient Vision Care Safety (NPRM
                Comment #3883); see CLR Panel IV Tr., supra note 121, at 19
                (statement of David Cockrell).
                 \503\ Jeun (NPRM Comment #1774); Daza (NPRM Comment #2002);
                CooperVision, Inc. (NPRM Comment #3841); Coalition for Patient
                Vision Care Safety (NPRM Comment #3883).
                 \504\ CooperVision, Inc. (NPRM Comment #3841); Coalition for
                Patient Vision Care Safety (NPRM Comment #3883).
                 \505\ CooperVision, Inc. (NPRM Comment #3841) (stating that
                evidence of the high number of patients being contacted in the last
                days of their prescription ``provides a powerful inference that
                sales in many situations are excessive''); Coalition for Patient
                Vision Care Safety (NPRM Comment #3883).
                ---------------------------------------------------------------------------
                 However, the concern is not whether consumers are purchasing lenses
                near the end of their prescription, but whether they are purchasing
                excessive quantities. As noted in the NPRM, the Johnson & Johnson
                Vision Care survey did not ask about the quantity of lenses purchased
                by consumers.\506\ The Commission had previously found that consumers
                typically do not purchase a year's supply of lenses at one time.\507\
                Additionally, 1-800 CONTACTS stated that it was aware of survey
                evidence it believed showed that six months is the average size of an
                order made during the last thirty days of a prescription, which is
                similar to, based on 1-800 CONTACTS internal data, the average quantity
                ordered throughout the duration of the prescription.\508\ Thus, the
                Commission does not have sufficient basis to conclude, despite
                anecdotal reports and alleged practices by some sellers, that consumers
                are purchasing lenses in excessive quantities near the end of their
                prescription.\509\ Neither does the Commission have sufficient evidence
                showing that consumers are going to eye care providers less frequently
                because they previously purchased large quantities of contact lenses.
                In fact, evidence suggests that a majority of consumers are seeing
                their eye care provider regularly. One survey found that contact lens
                wearers have an eye exam every thirteen months on average while another
                survey showed that about 56% of respondents received an eye exam every
                twelve months or less, with an overall average of approximately sixteen
                months.\510\ These surveys appear consistent with a prior survey by the
                Coalition for Patient Vision Care Safety, which found that 87% of
                contact lens wearers had an eye exam last year.\511\
                ---------------------------------------------------------------------------
                 \506\ NPRM, 81 FR at 88549-50; see also Johnson & Johnson Vision
                Care, Inc. (RFC Comment #582) (asking consumers whether a seller
                notified them that their prescription was expiring and whether they
                have ever ordered lenses within a month of their prescription's
                expiration).
                 \507\ NPRM, 81 FR at 88549.
                 \508\ 1-800 CONTACTS (NPRM Comment #3898) (stating that for a
                monthly contact lens the standard package size is six months, which
                is the minimum quantity available).
                 \509\ NPRM, 81 FR at 88549.
                 \510\ 1-800 CONTACTS (NPRM Comment #3898).
                 \511\ NPRM, 81 FR at 88549 n.308.
                ---------------------------------------------------------------------------
                 Some commenters also believe that a quantity limitation would not
                be difficult to implement when the seller has the prescription because
                sales could be limited to the amount of lenses necessary for the
                remaining period of the prescription or based on typical usage.\512\
                However, it would be impractical for sellers to determine whether the
                quantity of lenses being purchased is necessary or typical because such
                amounts may not be the same for all consumers. Additionally, as noted
                in the NPRM, there are legitimate reasons why a consumer may want to
                purchase a supply of lenses that exceeds the remaining period of the
                [[Page 50705]]
                prescription, including having enough lenses until the next scheduled
                appointment, having replacements for lost or torn lenses, or replacing
                lenses more frequently.\513\ Additionally, quantity limitations could
                encourage some consumers to stretch out their lens supply by wearing
                them longer than recommended, which is a well-documented health issue
                that outweighs the potential harm of patients purchasing a quantity of
                lenses that exceeds what is strictly anticipated by the remaining
                length of the prescription.\514\ Although it is possible that patients
                could purchase large quantities of lenses by presenting their
                prescription to multiple sellers, the Commission does not have evidence
                about the extent of such practice.\515\ Finally, when verification is
                used, a prescriber can determine whether the quantity ordered is
                excessive, and, if it is, inform the seller within the eight-business-
                hour period that the request is inaccurate and specify the appropriate
                amount of lenses.\516\ In conclusion, the Commission declines to modify
                the Rule to limit the quantity of lenses that consumers can purchase.
                ---------------------------------------------------------------------------
                 \512\ Contact Lens Institute (SNPRM Comment #79) (stating that
                the ``health and safety of patients requires limits on the sale of
                quantities of contact lenses beyond those reasonably required for
                patient use during the remaining term of a prescription'' and urging
                that a verification request for a prescription that is close to
                expiration be treated as an alteration because it seeks to dispense
                excessive quantities of lenses); Coalition for Patient Vision Care
                Safety (NPRM Comment #3883) (stating that ``when the seller has the
                prescription, no sale should exceed a supply of lenses necessary to
                last the remaining period of the prescription''); CooperVision, Inc.
                (NPRM Comment #3841).
                 \513\ NPRM, 81 FR at 88549; 1-800 CONTACTS (NPRM Comment #3898).
                 \514\ NPRM, 81 FR at 88549. See also 1-800 CONTACTS (NPRM
                Comment #3898) (citing survey data showing that 65% of participants
                tended to wear their last pair of contact lenses longer than when
                they have a supply of lenses).
                 \515\ NPRM, 81 FR at 88550.
                 \516\ 16 CFR 315.5(d); Contact Lens Rule, 69 FR at 40501; NPRM,
                81 FR at 88550 n.313.
                ---------------------------------------------------------------------------
                X. Expiration of Contact Lens Prescriptions
                 Section 315.6(a) of the Rule requires that a prescription expire on
                the date specified by the law of the state in which the prescription
                was written, if that date is one year or more after the issue date of
                the prescription.\517\ The Rule also provides that a prescription shall
                not expire less than one year after the issue date of the prescription,
                unless the prescriber specifies a shorter period that is ``based on the
                medical judgment of the prescriber with respect to the ocular health of
                the patient'' and documents the reasoning for the shorter expiration
                period in the patient's medical record.\518\
                ---------------------------------------------------------------------------
                 \517\ 16 CFR 315.6(a)(1).
                 \518\ 16 CFR 315.6(a)(2)-(3); 16 CFR 315.6(b)(1).
                ---------------------------------------------------------------------------
                 The NPRM addressed comments requesting that the Commission set a
                longer minimum length for prescriptions, prohibit expirations on
                certain prescriptions, or leave prescription length to the sole
                discretion of the provider.\519\ However, because the Rule's provisions
                closely track the Act, which sets a minimum expiration date ``to
                prevent prescribers from selecting a short expiration date . . . that
                unduly limits the ability of consumers to purchases contact lenses''
                and because the Commission concluded that, in drafting the Act,
                Congress intended to defer to state law except where such law
                establishes a period of less than one year, the Commission stated that
                the current framework is appropriate and declined to make changes.\520\
                The NPRM also addressed prescriber reports of patients obtaining
                contact lenses through sellers, especially online sellers, with expired
                contact lens prescriptions.\521\ Commenters requested a Rule change or
                greater enforcement of the Rule to deal with this problem.\522\
                However, finding that the Rule sufficiently prohibited the use of
                expired prescriptions, the Commission declines to amend the Rule.\523\
                ---------------------------------------------------------------------------
                 \519\ NPRM, 81 FR at 88546.
                 \520\ Id.; see also 15 U.S.C. 7604.
                 \521\ NPRM, 81 FR at 88546-47.
                 \522\ Id.
                 \523\ Id. at 88547.
                ---------------------------------------------------------------------------
                A. Length of Contact Lens Prescriptions
                 Following the NPRM's discussion of expiration length, the
                Commission received additional comments that favored making
                prescriptions valid for more than one year.\524\ Some commenters
                advocated for such change because they believed that prescriptions
                rarely change \525\ or that consumers would save money if they needed
                to obtain exams less often.\526\ Other commenters expressed concern
                that shorter prescription expirations may have the undesirable result
                of encouraging consumers to wear contacts for longer than recommended
                \527\ or that there should not be a standard minimum expiration in the
                Rule due to variations in patient needs.\528\
                ---------------------------------------------------------------------------
                 \524\ Radcliffe (WS Comment #2); Williams (WS Comment #1036);
                Yenovkian (WS Comment #1362); Yuen (NPRM Comment #1854); Susswein
                (NPRM Comment #3759).
                 \525\ Radcliffe (WS Comment #2); Williams (WS Comment #1036).
                 \526\ Williams (WS Comment #1036); Yuen (NPRM Comment #1854).
                 \527\ Berenguer (WS Comment #111).
                 \528\ Moss (WS Comment #837).
                ---------------------------------------------------------------------------
                 However, some manufacturer and prescriber organizations favored
                maintaining the Rule's current expiration provisions. Johnson & Johnson
                Vision Care stated that the current Rule ``ensures that patients
                continue to receive the vital professional oversight to decrease
                avoidable risks and increases patient access to the latest technologies
                to best meet their vision care needs.'' \529\ Likewise, the AOA and the
                Contact Lens Institute supported the Commission maintaining the Rule's
                current prescription length provisions.\530\
                ---------------------------------------------------------------------------
                 \529\ Johnson & Johnson Vision Care, Inc. (NPRM Comment #4327).
                Peter Menziuso, President of JJVCI, also echoed this sentiment at
                the workshop, stating that the company feels strongly about
                maintaining the one-year expiration to assure patients are seeing
                their prescriber regularly and prioritizing health. See CLR Panel IV
                Tr., supra note 121, at 16.
                 \530\ Contact Lens Institute (SNPRM Comment #79); American
                Optometric Association (NPRM Comment #3830).
                ---------------------------------------------------------------------------
                 After reviewing the comments, the Commission again declines to
                modify or remove the Rule's prescription length provisions. The current
                Rule closely tracks the Act, which Congress mandated, and already
                contains provisions that allow for prescriptions longer than one year,
                dependent upon state law, and shorter than one year, when those are
                appropriate based on the medical judgment of the prescriber, ensuring
                flexibility.\531\ The Commission does not find the record adequately
                supports lengthening the Rule's prescription expiration provisions.
                Therefore, the Commission declines to alter the Rule's provisions
                relating to prescription length.
                ---------------------------------------------------------------------------
                 \531\ 16 CFR 315.6(a)(2)-(3); 16 CFR 315.6(b)(1).
                ---------------------------------------------------------------------------
                B. Sales Using Expired Contact Lens Prescriptions
                 After the NPRM, commenters again raised the issue of sellers
                selling contact lenses past the prescription expiration dates,\532\ and
                some argued that additional regulation is needed.\533\ The Rule already
                makes clear that expired prescriptions are invalid and prohibits
                [[Page 50706]]
                sales with such prescriptions.\534\ If a consumer presents the seller
                with an expired prescription, the seller cannot use it as the basis for
                the sale. Not only is the seller unable to base a sale on that expired
                prescription, but as the Commission clarified in the NPRM, a seller may
                not use an expired prescription as the basis for a verification
                request.\535\ If, however, a seller is presented with a prescription
                that lacks an expiration date,\536\ and that seller does not have
                knowledge as to whether the prescription is expired, the seller must
                verify the prescription with the prescriber prior to dispensing lenses.
                In this instance, the seller may rely on the prescriber to inform the
                seller if the prescription is expired.\537\
                ---------------------------------------------------------------------------
                 \532\ See, e.g., Hanian (SNPRM Comment #27); Pirozzolo (SNPRM
                Comment #33); Wilkes (SNPRM Comment #86); AOA (SNPRM Comment #96);
                Parikh (SNPRM Comment #152); Fuller (WS Comment #531); McBride (WS
                Comment #630); Swindell (WS Comment #682); Hamilton (WS Comment
                #781); Caywood (WS Comment #788); Matus (WS Comment #1534); Malaski
                (WS Comment #3160); DiGirolamo (NPRM Comment #23); Endry (NPRM
                Comment #29); Ross (NPRM Comment #48); Hanen-Smith (NPRM Comment
                #154); Weisz (NPRM Comment #963); Helwig (NPRM Comment #2349);
                Simpson (NPRM Comment #2896); Holle (NPRM Comment #3214); Gordon
                (NPRM Comment #3544); Reinstein (NPRM Comment #3560); Sheffer (NPRM
                Comment #3577).
                 \533\ Kepley (SNPRM Comment #76); Radford (NPRM Comment #59);
                Rodriguez (NPRM Comment #3896) (``I was disappointed to learn that
                the FTC will not, under its existing authority, seek to more-fully
                address the many unscrupulous business practices of online contact
                lens sellers that have been putting the health and safety of
                patients at risk for more than a decade. Expired contact lens
                prescriptions are regularly processed and filled by these online
                business.''); Huang (NPRM Comment #2203); Avila (NPRM Comment #52);
                Hanen-Smith (NPRM Comment #154); Letter from Senator Heidi Heitkamp
                to Acting Chairwoman Maureen Ohlhausen (Jan. 5, 2018); Letter from
                Congressman Jeff Denham et al. to Chairman Joseph Simons (July 27,
                2018).
                 \534\ 16 CFR 315.5(d).
                 \535\ NPRM, 81 FR at 88546-47.
                 \536\ 16 CFR 315.2.
                 \537\ NPRM, 81 FR at 88547.
                ---------------------------------------------------------------------------
                 CooperVision requested that the Commission require that sellers,
                when not in possession of an unexpired prescription, ask consumers if
                their prescriptions have expired.\538\ In the NPRM, the Commission
                addressed a similar request by AOA to require sellers to include the
                expiration and issue dates, both required elements of a prescription,
                in verification requests.\539\ According to the AOA, this requirement
                would incentivize sellers to make sure patients know their prescription
                expiration date. However, as explained in the NPRM, the seller would
                not necessarily have the expiration or issue dates, and neither would
                the patient.\540\ A better source for this information is the
                prescriber, who has the ability to invalidate a prescription request
                because it is expired.\541\ For this reason, the Commission will not
                implement CooperVision's proposal. Additionally, a number of prescriber
                organizations expressed concerns that consumers are able to buy lenses
                on expired prescriptions because of passive verification.\542\ Further,
                to lessen the chances of the sale of lenses after the expiration of a
                prescription, some commenters requested that the Commission require
                that prescriptions be presented at the time of the sale of lenses.\543\
                As stated in Section V, Congress mandated passive verification, and
                requiring prescription presentation would be inconsistent with
                Congress's intent. The Final Rule also includes several changes to
                automated verification calls that will improve passive verification by
                allowing prescribers to better identify requests based on expired
                prescriptions.\544\
                ---------------------------------------------------------------------------
                 \538\ CooperVision, Inc. (SNPRM Comment #130).
                 \539\ NPRM, 81 FR at 88547 (citing AOA Comment #644).
                 \540\ NPRM, 81 FR at 88547.
                 \541\ As explained in the Alteration section, Section VI, supra,
                if a seller wishes to avail itself of the exception to alteration,
                it may use an expired prescription as an indication of manufacturer
                or brand if the minimum criteria discussed in that Section are met,
                and the seller obtains additional information, from the consumer or
                the prescriber, that the consumer has a current prescription for
                that brand. In so doing, the seller obtains a basis for the
                verification request other than the expired prescription.
                 \542\ Contact Lens Institute (SNPRM Comment #79) (``Indeed, CLI
                remains concerned about the contribution of passive verification via
                robocalls to filling expired or invalid prescriptions . . .'');
                American Society of Cataract and Refractive Surgery (SNPRM Comment
                #127) (``Significant concerns with patient safety, as the current
                eight-hour validation window allows inaccurate, falsified, and
                expired contact lens prescriptions to be filled. Subsequently,
                patients' ocular health is put at risk because of a restricted
                validation period.''); American Society of Cataract and Refractive
                Surgery (NPRM Comment #3820) (``Many of our members practice in solo
                or small practices that often do not have the resources to respond
                to verification requests within the eight-hour time frame. This rule
                allows a seller to fill a prescription that is inaccurate, expired,
                or falsified simply because the prescriber has been unable to
                respond within eight hours. As a result, patients suffer serious eye
                injuries by wearing ill-fitted contacts.''); Massachusetts Society
                of Eye Physicians and Surgeons (NPRM Comment #4270).
                 \543\ Sanders (SNPRM Comment #61); Wisniewski (NPRM Comment
                #1769); Hanian (NPRM Comment #153).
                 \544\ See Section III, supra.
                ---------------------------------------------------------------------------
                 Finally, commenters again requested that the Commission bring
                enforcement actions against sellers that sell lenses after the
                expiration of the prescription.\545\ As stated in the NPRM, if the
                Commission receives credible evidence that sellers are selling contact
                lenses when they have actual knowledge that the prescriptions are
                expired (either because they were presented with a copy of an expired
                prescription or received a response from a prescriber within the time
                frame specified in the Rule telling the seller that the prescription is
                expired), the Commission will take appropriate steps to investigate the
                allegations.\546\
                ---------------------------------------------------------------------------
                 \545\ Cooper Vision, Inc. (SNPRM Comment #130); Stout (WS
                Comment #450); Stolicker (NPRM Comment #10); Osetek (NPRM Comment
                #22); Bass (NPRM Comment #55); Coalition for Patient Vision Care
                Safety (NPRM Comment #3883); Letter from Congressman David Roe to
                Chairman Joseph Simons (Nov. 29, 2018).
                 \546\ NPRM, 81 FR at 88547.
                ---------------------------------------------------------------------------
                XI. Paperwork Reduction Act
                 The existing Rule contains recordkeeping and disclosure
                requirements that constitute ``collection[s] of information'' as
                defined by 5 CFR 1320.3(c) under Office of Management and Budget
                (``OMB'') regulations that implement the Paperwork Reduction Act
                (``PRA''), 44 U.S.C. 3501 et seq.\547\ On May 28, 2019, the Commission
                issued a SNPRM proposing amendments that would contain new information
                collection requirements subject to OMB review and approval.
                Specifically, the SNPRM estimated an additional recordkeeping burden
                for prescribers resulting from the proposed Rule modifications to
                597,917 hours (85,417 hours regarding signatures + 512,500 hours
                regarding their retention) and the associated estimated annual labor
                cost burden of $13,244,727.\548\ On the same date, the Commission also
                submitted a request to OMB seeking approval for the new information
                collections associated with the proposed rulemaking. On September 20,
                2019, the OMB directed the Commission to examine public comments
                relating to the proposed rulemaking and describe any public comments
                received regarding the collection, as well as why the Commission did or
                did not incorporate the commenter's recommendation.\549\ Below, the
                Commission describes and discusses the amendments to the Final Rule,
                the public comments received relating to the collection of information
                burden associated with the SNPRM, and the Commission's ultimate
                determination of the burden generated by the final amendments.
                ---------------------------------------------------------------------------
                 \547\ On October 2, 2019, the Commission requested permission
                from OMB to continue these pre-existing information collections,
                which were estimated to be 2,104,050 annual hours of burden (which
                were derived by adding 1,045,650 disclosure hours for contact lens
                prescribers to 1,058,400 recordkeeping hours for contact lens
                sellers). See 84 FR 51162 (Sept. 27, 2019); Agency Information
                Collection Activities; Submission for OMB. On December 9, 2019, OMB
                approved the Rule's existing information collection requirements
                through December 31, 2022. OMB Control No. 3804-0127. See 84 FR
                51162 (Sept. 27, 2019); Agency Information Collection Activities;
                Submission for OMB Review; Comment Request.
                 \548\ See 84 FR at 24693-94 (May 28, 2019); Supplemental notice
                of proposed rulemaking; request for public comment.
                 \549\ OMB Control No. 3804-0127, ICR Reference No. 201910-3084-
                001, Notice of Office of Management and Budget Action (Sept. 10,
                2019).
                ---------------------------------------------------------------------------
                 The Commission has made a number of modifications to the Rule that
                contain recordkeeping requirements that are collections of information
                as defined by 5 CFR 1320.3(c). First, the Rule has been modified to
                require that prescribers either: (A) Obtain from patients, and maintain
                for a period of not less than three years, a signed confirmation of
                prescription release on a separate stand-alone document; (B) obtain
                from patients, and maintain for a period of not less than three years,
                a patient's signature on a confirmation of prescription release
                included on a copy of a patient's prescription; (C) obtain from
                patients, and maintain for a period of not less than three years, a
                patient's signature on a confirmation of
                [[Page 50707]]
                prescription release included on a copy of a patient's contact lens
                fitting sales receipt; or (D) provide each patient with a copy of the
                prescription via online portal, electronic mail, or text message, and
                for three years retain evidence that such prescription was sent,
                received, or, if provided via an online-patient portal, made
                accessible, downloadable, and printable by the patient.\550\ For
                prescribers who choose to offer an electronic method of prescription
                delivery, the Final Rule requires that such prescribers identify the
                specific method or methods to be used, and maintain records or evidence
                of affirmative consent by patients to such digital delivery for three
                years.\551\ For instances where a consumer refuses to sign the
                confirmation or accept digital delivery of their prescription, the
                Final Rule directs the prescriber to note the refusal and preserve this
                record as evidence of compliance.\552\ None of these new requirements,
                however, would apply to prescribers who do not have a direct or
                indirect financial interest in the sale of contact lenses.\553\
                ---------------------------------------------------------------------------
                 \550\ 16 CFR 315.3(c)(1).
                 \551\ 16 CFR 315.2.
                 \552\ 16 CFR 315.3(c)(1)(iii).
                 \553\ 16 CFR 315.3(c)(3).
                ---------------------------------------------------------------------------
                 Additional modifications to the Rule that constitute collections of
                information as defined by 5 CFR 1320.3(c) require that sellers who use
                calls containing automated verification messages: (1) Record the entire
                call; (2) commence the call by identifying it as a request for
                prescription verification; (3) provide the information required by
                Sec. 315.5(b) in a slow and deliberate manner and at a reasonably
                understandable volume; and (4) give the prescriber the option to repeat
                the information.\554\ The call recordings must be preserved for at
                least three years.\555\
                ---------------------------------------------------------------------------
                 \554\ 16 CFR 315.5(d).
                 \555\ 16 CFR 315.5(h)(4).
                ---------------------------------------------------------------------------
                 The Commission hereby provides PRA burden estimates, analysis, and
                discussion for the requirements to collect patient signatures as
                confirmation of prescription release and as consent to electronic
                prescription delivery; and the requirement to record automated
                verification messages; and associated recordkeeping obligations.
                A. Confirmation of Prescription Release and Affirmative Consent to
                Digital Delivery of a Prescription
                1. SNPRM Burden Estimate for the Confirmation of Prescription Release
                 In its SNPRM, the Commission put forth estimates for the additional
                burden on individual prescribers' offices to generate and present to
                patients the confirmations of prescription release, and to collect and
                maintain the confirmations of prescription release for a period of not
                less than three years.\556\ As set out in the PRA section's
                introductory paragraph above, the Commission previously calculated this
                burden to be 597,917 hours (85,417 hours for prescribers to collect
                patient signatures and 512,500 hours for prescribers' office staff to
                store them).\557\ Based on average hourly wage rates, the Commission
                calculated the aggregate labor cost burden (totaling prescribers and
                prescribers' office staff) at $13,244,727.\558\ The Commission noted,
                however, that arguably, the overall burden of the Rule--including
                verification costs previously approved by the Office of Management and
                Budget \559\--could be lower (or not increase) given the proposed
                modification's potential offsetting effects of more patients being in
                possession of their prescriptions and consequently fewer
                verifications.\560\
                ---------------------------------------------------------------------------
                 \556\ SNPRM, 84 FR at 24692.
                 \557\ Id. at 24693.
                 \558\ Id. at 24694. This estimate was based on a mean hourly
                wage of $57.26 for optometrists and $16.30 for office clerks.
                Economic News Release, U.S. Dep't of Labor, Bureau of Labor
                Statistics, Table 1. National employment and wage data from the
                Occupational Employment Statistics survey by occupation, May 2017.
                 \559\ See note 549, supra.
                 \560\ SNPRM, 84 FR at 24693-94.
                ---------------------------------------------------------------------------
                 The Commission requested comment on the accuracy of the FTC's
                burden estimates, including whether the methodology and assumptions
                used are valid (such as whether prescribers or office staff are more
                likely to collect patient signatures and retain associated
                recordkeeping), and a quantification of the reduction in verifications
                resulting from the confirmation of prescription proposal.\561\
                ---------------------------------------------------------------------------
                 \561\ Id.
                ---------------------------------------------------------------------------
                2. Comments Regarding the SNPRM Estimate for the Confirmation of
                Prescription Release Requirement
                 In response to the Commission's SNPRM proposal, several commenters
                reiterated that obtaining and storing the Confirmations of Prescription
                Release would create ``onerous'' administrative and financial burdens,
                but most commenters did not supply financial estimates for this
                burden.\562\ The AOA, which had previously estimated the cost of the
                NPRM's signed-acknowledgment proposal to be as high as $18,795 per
                optometrist,\563\ did not submit a new burden estimate for the
                Confirmation of Prescription Release proposal, but did opine that the
                increased flexibility of the new proposal would not reduce the overall
                burden on prescribers.\564\ One commenter estimated that it would cost
                his practice $10,000 per year in ``paperwork, storage, and time spent
                by secretaries handling paperwork,'' but did not provide details about
                his practice (the number of patients and prescribers, for instance) or
                how the estimate was derived, and what the cost amounted to on a per-
                patient or per-prescription basis.\565\ Another commenter, Dr. Thomas
                Steinemann, wrote, ``I dispute the FTC contention that each
                documentation will only take `one minute.' Additional documentation can
                actually take several minutes when there are discrepancies in
                verification.'' \566\ Dr. Steinemann commented that according to his
                office manager, the ``additional steps of verification and
                documentation'' would add 10 minutes of administrative time per
                patient.\567\ The comment, however, does not articulate how the
                Confirmation of Prescription Release requirement can create
                discrepancies in verification, or what ``additional steps of
                verification'' Dr. Steinemann or his office manager are referring to.
                The Confirmation of Prescription Release requirement does not directly
                impact the requirement that prescribers verify prescriptions upon
                request, other than to potentially make such requests less common if
                more patients have possession of their prescriptions and can present
                them to sellers when ordering.
                ---------------------------------------------------------------------------
                 \562\ See Section II.C.7, supra.
                 \563\ American Optometric Association (NPRM Comment #3830). As
                noted in note 247, supra, the Commission explained in the SNPRM that
                it could not accord this estimate significant weight because it was
                based not on the cost of the proposed Signed Acknowledgment but on
                the overall cost of government regulations (including those already
                in place), and because the survey had numerous methodological
                limitations. SNPRM, 84 FR at 24677.
                 \564\ American Optometric Association (SNPRM Comment #96). A few
                SNPRM commenters reiterated the AOA's $18,000 estimate (which the
                Commission previously determined it could not rely on, for reasons
                explained in the SNPRM), 84 FR at 24677, but did not provide
                additional information or empirical support for this figure. Koerber
                (SNPRM Comment #110); American Society of Cataract and Refractive
                Surgery (SNPRM Comment #127).
                 \565\ Pierce (SNPRM Comment #17).
                 \566\ Steinemann (SNPRM Comment #65); Steinemann (SNPRM Comment
                #138).
                 \567\ Id.
                ---------------------------------------------------------------------------
                 In contrast to those critical of the burden and the Commission's
                SNPRM PRA analysis, other commenters contended that the burden of the
                new requirement would be minimal or offset by a reduced burden in other
                respects of the Rule.\568\ One commenter, the ITIF, asserted that
                evidence that the new
                [[Page 50708]]
                requirement would increase prescriber costs ``appears to be
                significantly overstated,'' and noted that storing confirmation
                signatures in paper takes up ``very little room and cost,'' and, if
                stored electronically, storage costs are ``essentially zero.'' \569\
                The ITIF also stated allowing prescribers to deliver prescriptions
                digitally would reduce the ``already small'' burden on prescribers of
                the confirmation of release requirement, and at the same time reduce
                the number of verification calls from third party lens sellers, thus
                further reducing the overall burden on both sellers and
                prescribers.\570\
                ---------------------------------------------------------------------------
                 \568\ See Section II.C.7, supra.
                 \569\ Information Technology & Innovation Foundation (SNPRM
                Comment #103).
                 \570\ Id. See also National Association of Optometrists and
                Opticians (SNPRM Comment #129) (stating that with more practitioners
                moving to practice management systems and electronic health records,
                digital delivery of contact lens prescriptions is a ``very
                feasible'' option for many prescribers, which will further reduce
                the burden of the confirmation requirement).
                ---------------------------------------------------------------------------
                 Another commenter, the National Taxpayers Union (``NTU''), felt the
                SNPRM burden-estimates were ``plausible,'' and noted that the FTC's
                estimates were based on underlying assumptions that may be overly
                cautious, and thus lead to overcounting.\571\ In particular, the NTU
                noted that the Commission, in calculating the SNPRM's PRA burden: (1)
                Assumed that only optometrists would obtain patient signatures, when,
                in fact, support staff--who are paid less per hour--are permitted to do
                so; (2) provided sample confirmation language so prescribers wouldn't
                have to formulate their own; (3) assumed that every provider would
                spend a minute per confirmation even though states already impose
                recordkeeping requirements, and electronic storage might take seconds;
                and (4) did not account for potentially offsetting reductions in burden
                hours for eye care providers due to reduced time and effort spent
                responding to verification requests (since more patients would have
                possession of their prescriptions and be able to present them to third-
                party contact lens sellers).\572\
                ---------------------------------------------------------------------------
                 \571\ National Taxpayers Union (SNPRM Comment #149).
                 \572\ Id. See also National Association of Optometrists and
                Opticians (SNPRM Comment #129) (stating that with more patients in
                possession of their prescriptions, there would be fewer orders
                relying on the verification process).
                ---------------------------------------------------------------------------
                 Likewise, 1-800 CONTACTS submitted a new analysis from Stanford
                Health Research Professor Laurence Baker that called the Commission's
                burden analysis ``conservative,'' and estimated that a reduction in
                verification requests by 13-15% would be sufficient to offset all of
                the costs of the confirmation requirement.\573\
                ---------------------------------------------------------------------------
                 \573\ 1-800 CONTACTS (SNPRM Comment #135).
                ---------------------------------------------------------------------------
                 None of the SNPRM commenters offered detailed suggestions for
                reducing the burden resulting from the Confirmation of Prescription
                Release proposal, other than to suggest that the Commission withdraw
                its proposal completely or choose a substantially different
                alternative, such as signage or public education.\574\ For reasons
                discussed in Section II.C.6., supra, the Commission does not believe
                such alternatives would effectively serve the purpose of the Rule.
                ---------------------------------------------------------------------------
                 \574\ See Section II.C.6, supra.
                ---------------------------------------------------------------------------
                3. Estimated Additional Burden Hours for the Confirmation of
                Prescription Release Requirement
                 Commission staff estimates the PRA burden of the Confirmation of
                Prescription Release requirement based on comments received and its
                long-standing knowledge and experience with the eye care industry.\575\
                Staff continues to believe there will be an additional burden on
                individual prescribers' offices to satisfy the confirmations of
                prescription release requirements, but that this burden will be
                relatively small in the context of the overall market for contact
                lenses and examinations.\576\
                ---------------------------------------------------------------------------
                 \575\ See Section I.B., supra, discussing the Commission's three
                decades of experience with the optical goods industry.
                 \576\ One survey estimated that the U.S. contact lens market
                totaled approximately $5,012,800,000 (not counting examination
                revenue) in 2017. ``Vision Markets See Continued Growth in 2017,
                VisionWatch Says,'' Vision Monday, March 20, 2018, http://www.visionmonday.com/business/research-and-stats/article/vision-markets-see-continued-growth-in-2017-visionwatch-says/. See also
                note 609 and accompanying text, infra.
                ---------------------------------------------------------------------------
                 The number of contact lens wearers in the United States is
                currently estimated to be approximately 45 million.\577\ Therefore,
                assuming an annual contact lens exam for each contact lens wearer, the
                Confirmation of Prescription Release requirement would require that 45
                million people either read and sign a Confirmation of Prescription
                Release or agree to receive their prescription electronically.
                ---------------------------------------------------------------------------
                 \577\ Centers for Disease Control, Healthy Contact Lens Wear and
                Care, Fast Facts, https://www.cdc.gov/contactlenses/fast-facts.html.
                This is an updated figure that represents an increase of four
                million wearers since the NPRM and SNPRM estimates were prepared.
                ---------------------------------------------------------------------------
                 Nothing in the comments to the SNPRM alters the Commission's belief
                that generating and presenting the Confirmation of Prescription Release
                will not require significant time or effort. The comments describing
                the burden as crippling and onerous do not contain empirical facts or
                data regarding the amount of time and cost of the Commission's
                proposal, and some estimates appear overstated.
                 The Commission continues to believe that creating the Confirmation
                of Prescription Release should not be difficult to implement since the
                requirement is flexible in that it allows any one of several different
                modalities and delivery methods, including adding the confirmation to
                existing documentation that prescribers routinely provide (sales
                receipts) or are already required to provide (prescriptions) to
                patients. The requirement is also flexible in that it does not
                prescribe other details such as the precise content or language of the
                patient confirmation, but merely requires that, if provided to the
                patient pursuant to options specified in Sec. 315.3(c)(1)(i)(A), (B),
                and (C), the confirmation from the patient must be in writing. At the
                same time, it is not required that prescribers spend time formulating
                their own content for the confirmation, since the Rule provides draft
                language that prescribers are free to use, should they so desire.
                Furthermore, the confirmation requirement is flexible enough to cover
                situations where a contact lens fitting is completed remotely, since a
                prescriber can readily satisfy the confirmation and prescription-
                release requirements by various methods, including email, text, or
                uploading the prescription to a patient portal, so long as the patient
                consents to such delivery.
                 The four options for a prescriber to confirm a prescription release
                to a patient are set out in Sec. 315.3(c)(1)(i)(A), (B), (C), and (D).
                The requirement in options (A), (B), and (C) to provide the patient
                with a Confirmation of Prescription Release statement are not
                disclosures constituting an information collection under the PRA
                because the FTC, in Sec. 315.3(c)(1)(ii), has supplied the prescriber
                with draft language the prescriber can use to satisfy this
                requirement.\578\ As noted above, however, the requirement in (A), (B),
                and (C) to collect a patient's signature on the Confirmation of
                Prescription Release and preserve it constitutes an information
                collection as defined by OMB regulations that implement the PRA.
                Nonetheless, the Commission believes it will require minimal time for a
                patient to read the confirmation and provide a signature. The
                Commission estimated in the SNPRM that it would
                [[Page 50709]]
                take patients ten seconds to read the one-sentence Confirmation of
                Prescription Release and provide a signature,\579\ and the Commission
                believes that ten seconds remains an appropriate estimate.
                ---------------------------------------------------------------------------
                 \578\ ``The public disclosure of information originally supplied
                by the Federal government to the recipient for the purpose of
                disclosure to the public is not included within'' the definition of
                ``collection of information.'' 5 CFR 1320.3(c)(2).
                 \579\ SNPRM, 84 FR at 24693. This estimate was based on
                responses to a consumer survey regarding how long it would take
                consumers to read the Signed Acknowledgment, and a prior PRA
                estimate for consumers to complete a similar signed acknowledgment.
                ---------------------------------------------------------------------------
                 The fourth option, Sec. 315.3(c)(1)(i)(D), does not, in and of
                itself, constitute an information collection under the PRA, since no
                new information that would not otherwise be provided under the Rule is
                provided to or requested from the patient.\580\ Excluding that option
                from consideration, and assuming the remaining three options are
                exercised with equal frequency, 75% of approximately 45 million annual
                prescription releases will entail reading and signing a confirmation
                statement. Thus, assuming ten seconds for each release, prescribers and
                their office staff would devote 93,750 hours, cumulatively (75% x 45
                million prescriptions yearly x 10 seconds each) to obtaining patient
                signatures as confirmations of prescription release.\581\
                ---------------------------------------------------------------------------
                 \580\ In order to utilize Sec. 315.3(c)(1)(i)(D), however, a
                prescriber must obtain and maintain records or evidence of
                affirmative consent by patients to electronic delivery of their
                prescriptions. 16 CFR 315.2. The burden to do so is included in the
                recordkeeping burden calculation of this PRA Section.
                 \581\ Section 315.3(c)(1)(iii) also requires that in the event
                that a patient declines to sign a confirmation requested under
                paragraphs (c)(1)(i)(A), (B), or (C), the prescriber must note the
                patient's refusal on the document and sign it. However, the
                Commission has no reason to believe that such notation should take
                any longer than for the patient to read and sign the document, so
                the Commission will maintain its calculation as if all confirmations
                requested under (c)(1)(i)(A), (B), or (C) require the same amount of
                time.
                ---------------------------------------------------------------------------
                 Maintaining those signed confirmations for a period of not less
                than three years should also not impose substantial new burdens on
                individual prescribers and office staff. The majority of states already
                require that optometrists keep records of eye examinations for at least
                three years,\582\ and thus many prescribers who opt to include the
                confirmation of prescription release on the prescription itself would
                be preserving that document, regardless. Similarly, most prescribers
                already retain customer sales receipts for financial accounting and
                recordkeeping purposes, and thus prescribers who opt to include the
                confirmation of prescription release on the sales receipt also could be
                retaining that document, regardless. Moreover, storing a one-page
                document per patient per year should not require more than a few
                seconds, and an inconsequential, or de minimis, amount of record space.
                Some prescribers might also present the Confirmation of Prescription
                Release in electronic form, enabling patients to sign a computer screen
                or tablet directly and have their confirmation immediately stored as an
                electronic document. For other prescribers, the new recordkeeping
                requirement would likely require that office staff either preserve the
                confirmation in paper format, or electronically scan the signed
                confirmation and save it as an electronic document. For prescribers who
                preserve the confirmation electronically by scanning it, Commission
                staff estimates that saving such a document would consume approximately
                one minute of staff time. Commission staff does not possess detailed
                information on the percentage of prescribers' offices that currently
                use and maintain paper forms, electronic forms, or that scan paper
                files and maintain them electronically. Thus, for purposes of this PRA
                analysis, Commission staff will assume that all prescriber offices who
                opt for Sec. 315.3(c)(1)(i) (A), (B), or (C) require a full minute per
                confirmation for recordkeeping arising from the modifications.
                Excluding from PRA consideration the fourth option, Sec.
                315.3(c)(1)(i)(D), as there is no signature to obtain or retain, and
                assuming that prescribers elect the other options three-fourths or 75%
                of the time, the recordkeeping burden for all prescribers to scan and
                save such confirmations would amount to 562,500 hours (75% x 45 million
                prescriptions yearly x one minute for scanning and storing) per year.
                ---------------------------------------------------------------------------
                 \582\ See, e.g., 246 Mass. Code Regs. Sec. 3.02 (requiring
                optometrists to maintain patient records for at least seven years);
                Wash. Admin. Code Sec. 246-851-290 (requiring optometrists to
                maintain records of eye exams and prescriptions for at least five
                years); Iowa Admin. Code r. 645-182.2(2) (requiring optometrists to
                maintain patient records for at least five years); Fla. Admin. Code
                r. 64B13-3.003(6) (requiring optometrists to maintain patient
                records for at least five years).
                ---------------------------------------------------------------------------
                 As noted previously, the fourth option for satisfying the
                Confirmation of Prescription Release requirement does not necessitate
                that prescribers obtain or maintain a record of the patient's signature
                confirming receipt of her prescription. However, as explained in Sec.
                315.2, under the Rule's now-modified definition of Provide to the
                patient a copy, in order to avail themselves of the fourth option,
                prescribers must obtain and maintain records or evidence of the
                patients' affirmative consent to electronic delivery for three years.
                In order to remain as cautious as possible in estimating the burden,
                the Commission will use the assumption that consumers sign such
                consents for electronic delivery pursuant to Sec. 315.3(c)(1)(i)(D)
                for one quarter of the 45 million prescriptions released per year,\583\
                and that this task would take the same amount of time as to obtain and
                maintain a signature of the patient's Confirmation of Prescription
                Release. Thus, the Commission will allot 218,750 hours \584\ for the
                time required for prescribers to obtain affirmative consents and
                maintain records of same.
                ---------------------------------------------------------------------------
                 \583\ 11,250,000 (45 million prescriptions x 25%).
                 \584\ 31,250 hours (11,250,000 prescriptions yearly x 10
                seconds) for obtaining the signature plus 187,500 hours (11,250,000
                affirmative consents x one minute) for storing such records.
                ---------------------------------------------------------------------------
                 Therefore, the estimated incremental PRA recordkeeping burden for
                prescribers and their staff resulting from the Confirmation of
                Prescription Release modifications to the Rule amounts to 906,250 total
                hours ((93,750 and 31,250 hours, respectively, to obtain signatures
                confirming release and consenting to electronic delivery) plus (562,500
                and 218,750 hours, respectively, to maintain such records for three
                years)).
                 As some commenters noted, the overall burden of the Rule--
                particularly verification costs previously approved by the Office of
                Management and Budget \585\--could lessen (or not increase by as much
                as the incremental burden from the proposed Rule modifications), given
                potentially offsetting effects presented by the Commission's Rule
                modifications.\586\ With more patients in possession of their
                prescriptions (due to increased prescription release), and a greater
                ability to present them to sellers (due to the modification requiring
                sellers to provide a method for patients to present prescriptions)
                fewer time-consuming verifications would be necessary.\587\
                ---------------------------------------------------------------------------
                 \585\ See note 549, supra.
                 \586\ See Information Technology & Innovation Foundation (SNPRM
                Comment #103); 1-800 CONTACTS (SNPRM Comment #135); National
                Taxpayers Union (SNPRM Comment #149).
                 \587\ Id.
                ---------------------------------------------------------------------------
                 Based on new projections from 1-800 CONTACTS \588\ and a previous
                analysis by the Commission,\589\ a decrease of between 13%-23% in
                verifications could be sufficient to offset the entire cost of the
                Confirmation of Prescription Release requirement. In the SNPRM,
                however, the Commission noted that these estimates rely on a number of
                assumptions, not all of which are confirmed as accurate.\590\
                Furthermore,
                [[Page 50710]]
                neither 1-800 CONTACTS, nor any other commenter, provided empirical
                data or projections as to how much the number of verifications will
                decline due to the Rule modifications. The Commission continues to lack
                this data, and thus cannot predict whether the verification decrease--
                should it occur--would be sufficient to offset any or all of the
                burden. Therefore, the Commission will not make an adjustment for
                offsetting effects and benefits at this time.
                ---------------------------------------------------------------------------
                 \588\ 1-800 CONTACTS (SNPRM Comment #135) (estimating that a
                reduction of 13%-15% in verifications would offset the estimated
                costs of the proposal).
                 \589\ SNPRM, 84 FR at 24693-94.
                 \590\ Id. at 24678. The calculation also does not take into
                account any of the benefit to consumers from having their
                prescriptions and being able to choose from among competing sellers;
                the savings consumers might achieve by purchasing lower-priced
                lenses; the improvements to health and safety due to a reduction in
                errors associated with invalid prescriptions currently verified
                through passive verification; and the Commission's ability to assess
                and verify compliance with the Rule.
                ---------------------------------------------------------------------------
                 For this specific reason, and the various cautious assumptions
                described above, the Commission's estimate of 906,250 total hours for
                prescribers and their staff resulting from the Confirmation of
                Prescription Release requirement may well overstate the burden of the
                modification. Furthermore, the actual burden should be even lower
                because none of the Confirmation of Prescription Release requirements
                apply to prescribers who do not have a direct or indirect financial
                interest in the sale of contact lenses. The Commission requested but
                did not receive comment on the percentage of prescribers who might be
                exempt, and does not currently possess sufficient information to
                determine what percentage of prescribers do not have a financial
                interest in the sale of contact lenses. The Commission thus has not
                reduced the estimated PRA burden accordingly at this time.
                4. Estimated Total Labor Cost Burden for the Confirmation of
                Prescription Release Modification
                 Commission staff derives labor costs by applying appropriate
                hourly-cost figures to the burden hours described above. The task to
                obtain patient confirmations and consent to electronic delivery could
                theoretically be performed by medical professionals (e.g.,
                optometrists, ophthalmologists) or their support staff (e.g.,
                dispensing opticians, medical technicians, office clerks). In the
                SNPRM, the Commission requested comment as to whether prescribers or
                office staff are more likely to collect patient signatures and retain
                associated recordkeeping, but did not receive significant guidance on
                this. Therefore, staff will continue to assume that optometrists will
                perform the task of collecting patient signatures, and staff will
                perform the labor pertaining to printing, scanning, and storing of
                documents, even though this may lead to some overcounting of the
                burden.
                 According to the Bureau of Labor Statistics, salaried optometrists
                earn an average wage of $57.68 per hour, and general office clerks earn
                an average wage of $16.92 per hour.\591\ Using the aforementioned
                estimate of 125,000 total prescriber labor hours for obtaining patient
                signatures, the resultant aggregate labor costs to obtain patient
                signatures is $7,210,000 (125,000 hours x $57.68).
                ---------------------------------------------------------------------------
                 \591\ Press Release, Bureau of Labor Statistics, United States
                Department of Labor, Occupational Employment Statistics--May 2018,
                https://www.bls.gov/news.release/ocwage.t01.htm.
                ---------------------------------------------------------------------------
                 As previously noted, Commission staff assumes that office clerks
                will typically perform the labor pertaining to the printing, scanning
                and storing of prescription release confirmations. Applying a mean
                hourly wage for office clerks of $16.92 per hour to the aforementioned
                estimate of 781,250 hours, cumulative labor costs for those tasks would
                total $13,218,750.
                 Therefore, combining the aggregate labor costs for both prescribers
                and office staff to obtain signed patient confirmations and consent to
                electronic delivery and preserve the associated records, the Commission
                estimates the total labor burden of the Confirmation of Prescription
                Release modification to be $20,428,750. This represents an increase
                from the SNPRM's estimated burden for the Confirmation of Prescription
                Release proposal due to a relatively large increase in the number of
                contact lens wearers now estimated by the Centers for Disease
                Control,\592\ increases in the estimated wages of optometrists and
                office staff by the Bureau of Labor Statistics,\593\ and the additional
                Rule modification requiring prescribers to collect and preserve
                patients' affirmative consent to electronic delivery of their
                prescriptions.
                ---------------------------------------------------------------------------
                 \592\ Centers for Disease Control, Healthy Contact Lens Wear and
                Care, Fast Facts, https://www.cdc.gov/contactlenses/fast-facts.html.
                 \593\ Press Release, Bureau of Labor Statistics, United States
                Department of Labor, Occupational Employment Statistics--May 2018,
                https://www.bls.gov/news.release/ocwage.t01.htm.
                ---------------------------------------------------------------------------
                5. Capital and Other Non-Labor Costs for the Confirmation of
                Prescription Release Requirement
                 The proposed recordkeeping requirements detailed above regarding
                prescribers impose negligible capital or other non-labor costs, as
                prescribers likely have already the necessary equipment and supplies
                (e.g., prescription pads, patients' medical charts, scanning devices,
                recordkeeping storage) to perform those requirements.
                B. Recording of Automated Telephone Messages
                 As noted above, the Commission has further modified the Rule to
                require that sellers who use automated verification messages record the
                calls and preserve the recordings for three years. In the SNPRM, the
                Commission staff did not put forth a specific burden estimate for this
                requirement, but rather sought comments to help inform such estimated
                burden, to the extent applicable.\594\
                ---------------------------------------------------------------------------
                 \594\ SNPRM, 84 FR at 24694.
                ---------------------------------------------------------------------------
                 The Commission received a few comments stating that the requirement
                presented a burden for sellers.\595\ 1-800 CONTACTS, for instance,
                commented that the requirement to store the recorded calls would impose
                a costly new burden while providing relatively few associated
                benefits.\596\ Consumer Reports essentially reiterated this view.\597\
                None of the commenters, however, provided data or cost figures that
                would help inform the Commission's estimated burden.
                ---------------------------------------------------------------------------
                 \595\ See Sections III.B., C. and D, supra.
                 \596\ 1-800 CONTACTS (SNPRM Comment #135).
                 \597\ Consumer Reports (SNPRM Comment #133).
                ---------------------------------------------------------------------------
                 The Commission does not believe that requiring sellers who use
                automated telephone messages for verification to record the calls and
                preserve the recordings will create a substantial burden. The
                requirement will not require additional labor time for sellers, since
                the verification calls will be for the same duration that they are now
                (the length of time required to submit the information required for
                verification under Sec. 315.5 (b)). However, the new requirement will
                likely require capital and other non-labor costs to record the calls
                and store them electronically. But sellers who utilize automated
                telephone messages for verification are already availing themselves of
                sophisticated communication technology, and thus should not find it
                daunting to implement technology to record such calls. Meanwhile the
                growth of digital recording technology, and the capital investment
                required for recording equipment and record storage, is rapidly
                declining and has been for some time.\598\ A phone service provider
                used by at least one online contact lens seller, for example,
                advertises that it charges a quarter of one cent ($.0025) for each
                minute recorded, plus a storage fee of $.0005-per-month for each minute
                of
                [[Page 50711]]
                recorded storage over 10,000.\599\ In other words, assuming each
                verification call requires three minutes of recording, the first 3333
                verification calls recorded and stored would cost $25 (three-fourths of
                one cent per call),\600\ and each additional verification call would
                cost approximately six cents apiece to record and store for three
                years.\601\ Other phone service providers surveyed advertise call-
                recording options such as $4.99 per gigabyte (about 5000 minutes) of
                recorded calls (about 4/10th of a cent per verification call),\602\ and
                1000 minutes of call recording for $14.95 (approximately 4.5 cents per
                verification call).\603\ Some services also advertise unlimited call-
                recording plans ranging anywhere from $20-70 a month, depending on how
                many lines, and how much storage is required.\604\ The costs of these
                services would vary depending on what other options are selected, how
                long storage is required, and the size of the order, among other
                things, and the Commission does not vouch for the sufficiency of any of
                these services. Rather, the Commission mentions these advertised
                promotions to demonstrate that the cost of recording calls does not
                appear to be burdensome. Moreover, the Commission believes, as stated
                in Section III, supra, that any incremental costs to sellers for
                recording calls is outweighed by the benefit to consumers and
                prescribers from curtailing invalid verification calls. For purposes of
                calculating the PRA burden, however, the Commission will estimate that
                each three-minute verification call costs five cents to record.
                ---------------------------------------------------------------------------
                 \598\ See Final Rule, Telemarketing Sales Rule, 68 FR 4622 (Jan.
                29, 2003) (discussing the cost for recording calls, and determining
                it was not a significant obstacle for telemarketers).
                 \599\ Twilio Support, https://support.twilio.com/hc/en-us/articles/223132527-How-much-does-it-cost-to-record-a-call-.
                 \600\ (10,000 minutes x $.0025) / 3333 three-minute calls =
                $.0075 per call.
                 \601\ Id. For each additional three-minute verification call, it
                would cost three-quarters of a cent to record and .15 of a cent per
                month to store the recording (5.4 cents for 36 months), for a total
                of 6.15 cents per call.
                 \602\ https://getvoip.com/blog/2017/11/16/call-recording/; see
                also https://jive.com/features/call-recording (estimating that one
                gigabyte typically stores about 5,000 minutes of recorded calls).
                 \603\ https://www.phone.com/pricing-all/.
                 \604\ https://www.avoxi.com/blog/best-call-recording-service/.
                ---------------------------------------------------------------------------
                 According to recent survey data, approximately 36% of contact lens
                purchases are from a source other than the prescriber.\605\ Assuming
                that each of the 45 million contact lens wearers in the U.S. makes one
                purchase per year, this would mean that approximately 16,200,000
                contact lens purchases (45 million x 36%) are made annually from
                sellers other than the prescriber. Based on prior discussions with
                industry, approximately 73% of sales by non-prescriber sellers require
                verification, meaning that approximately 11,826,000 purchases would
                require verification calls, faxes, or emails (16,200,000 x 73%). The
                Commission does not possess information as to the percentage of
                verifications completed by telephone versus fax or email. Thus for
                purposes of this analysis, the Commission will assume that all
                verifications are performed via telephone. Furthermore, the Commission
                does not have information as to the percentage of telephone
                verifications that are automated as opposed to live calls, and thus
                will assume that all telephone verifications are automated calls and
                subject to the new call-recording requirement.
                ---------------------------------------------------------------------------
                 \605\ Jason J. Nichols & Deborah Fisher, ``2018 Annual Report,''
                Contact Lens Spectrum, Jan. 1, 2019, https://www.clspectrum.com/issues/2019/january-2019; VisionWatch, Contact Lenses, September
                2019.
                ---------------------------------------------------------------------------
                 Based on the aforementioned assumptions, the Commission estimates
                that the requirement to record automated telephone messages will
                require recording 11,826,000 calls \606\ at an annual cost to third-
                party sellers, in the aggregate, of $591,300 (11,826,000 x $.05).
                ---------------------------------------------------------------------------
                 \606\ In some instances, sellers may have to call more than once
                to verify an order. In those instances, however, only the recording
                of the successful verification would need be preserved.
                ---------------------------------------------------------------------------
                C. Total Burden for the Modifications to the Rule
                 Combining the marginal cost of the Rule modifications for both
                sellers and prescribers, the Commission estimates that the amendments
                will impose an additional burden of $21,020,050 ($20,428,750 for
                prescribers + $591,300 for third-party sellers). Adding these estimated
                costs to the OMB's already approved existing cost burden ($84,548,448)
                results in a total PRA burden from the Rule of $105,568,498. While not
                insubstantial, this represents just two percent of the overall
                $5,012,800,000 contact lens market in the United States.\607\ Moreover,
                as noted previously, the estimated burden is calculated using several
                cautious assumptions that may overstate the actual cost; in all
                likelihood, the actual burden will be significantly less.
                ---------------------------------------------------------------------------
                 \607\ ``Vision Markets See Continued Growth in 2017, VisionWatch
                Says,'' Vision Monday, March 20, 2018, http://www.visionmonday.com/business/research-and-stats/article/vision-markets-see-continued-growth-in-2017-visionwatch-says/. See also, Steve Kodey, US Optical
                Market Eyewear Overview, 4, https://www.ftc.gov/sites/default/files/filefield_paths/steve_kodey_ppt_presentation.pdf.
                ---------------------------------------------------------------------------
                XII. Regulatory Flexibility Act
                 The Regulatory Flexibility Act (``RFA'') \608\ requires that the
                Commission provide an Initial Regulatory Flexibility Analysis
                (``IRFA'') with a Proposed Rule, and a Final Regulatory Flexibility
                Analysis (``FRFA'') with the Final Rule, unless the Commission
                certifies that the Rule will not have a significant economic impact on
                a substantial number of small entities.\609\ The purpose of the
                regulatory flexibility analysis is to ensure that the agency considers
                the impact on small entities and examines regulatory alternatives that
                could achieve the regulatory purpose while minimizing burdens on small
                entities.
                ---------------------------------------------------------------------------
                 \608\ 5 U.S.C. 601-612.
                 \609\ 5 U.S.C. 603-605.
                ---------------------------------------------------------------------------
                 Although the Commission believed that the amendments it proposed
                would not have a significant economic impact on small entities, it
                included an IRFA in the SNPRM and solicited public comment.\610\ In
                this section, the Commission discusses the SNPRM comments that
                addressed the IRFA,\611\ as appropriate, below. The Final Rule is
                similar to the rule proposed in the SNPRM. The Commission continues to
                believe that the amendments it is adopting will not have a significant
                economic impact upon small entities, but has nonetheless deemed it
                appropriate as a matter of discretion to provide this FRFA.
                ---------------------------------------------------------------------------
                 \610\ SNPRM, 84 FR at 24694. The Commission's NPRM also included
                an IRFA. NPRM, 81 FR at 88588.
                 \611\ Unlike many other commenters who addressed the IRFA
                indirectly, the AOA commented on the RFA by name stating its belief
                that the Commission ``has not fully considered the regulatory burden
                under which physicians are already operating'' and cited to the
                Office of Advocacy of the U.S. Small Business Administration's FY
                2018 Report on the Regulatory Flexibility Act. According to the AOA,
                that report stated that ``[s]mall businesses have told advocacy
                stories that exemplify how federal regulations drain small
                businesses' resources, energy, and in some cases even their desire
                to stay in business.'' The AOA indicated that it ``has heard the
                same concerns voiced by doctors of optometry who after years of
                service in patient care find that the regulatory framework is so
                intrusive to the doctor patient relationship, [sic] that some
                consider leaving the profession.'' SNPRM Comment #96.
                ---------------------------------------------------------------------------
                A. Need for and Objectives of the Rule Amendments
                 The Commission's Final Rule incorporates changes affecting
                prescribers and sellers. These changes were, in large part, previously
                addressed in the Commission's NPRM and SNPRM, including in the
                Regulatory Flexibility Act sections. As explained in the earlier IRFAs,
                the need for and objective of these changes is to clarify
                [[Page 50712]]
                and update the Rule in accordance with marketplace practices.
                1. Amendments Affecting Prescribers
                 The following changes affect prescribers, many of whom are small
                businesses: (1) Should the prescriber so choose, allow for electronic
                delivery of prescriptions as a means for automatic prescription release
                when agreed to by the patient (and in such cases, prescribers must
                retain evidence for not less than three years that the prescription was
                sent, received, or made accessible, downloadable, and printable). The
                prescriber must identify to the patient the specific method of
                electronic delivery and obtain the patient's consent to that method,
                and maintain the evidence of consent for a period of not less than
                three years; (2) Request the patient sign a confirmation of receipt of
                a contact lens prescription (and if a patient declines to sign, must
                note the patient's refusal on the document and sign it); \612\ and (3)
                Respond to authorized seller requests for copies of a prescription
                within forty business hours, and require the prescriber to make a
                notation in the patient's record when responding to such requests.
                ---------------------------------------------------------------------------
                 \612\ This requirement does not apply to prescribers who do not
                have a direct or indirect financial interest in the sale of contact
                lenses.
                ---------------------------------------------------------------------------
                 As explained in detail in this Final Rule notice, the Commission
                has determined that a Confirmation of Prescription Release is necessary
                for several reasons, including: (1) Multiple consumer surveys
                consistently show prescriber non-compliance with, and lack of consumer
                awareness of, the Rule's prescription-release requirement; (2) numerous
                personal accounts of prescribers' failure to release prescriptions; (3)
                the persistently high number of verifications, many of which would be
                unnecessary were consumers in possession of their prescriptions; (4)
                the regulatory structure of the contact lens market, which requires a
                consumer to obtain lenses pursuant to a prescription while permitting
                prescribers to sell what they prescribe, thus creating an incentive for
                prescribers to withhold prescriptions; and (5) the lack of credible
                empirical evidence rebutting or contradicting the evidence that
                prescribers are not automatically releasing prescriptions, and that
                consumers are not fully aware of their rights.\613\
                ---------------------------------------------------------------------------
                 \613\ See Section II, supra.
                ---------------------------------------------------------------------------
                 The Commission further determined that allowing prescribers to
                satisfy the automatic prescription release requirement by using an
                online patient portal or other electronic method in lieu of a paper
                copy, when the patient gives verifiable affirmative consent, offered
                benefits for sellers, prescribers, and patients. Patients would be able
                to access their prescriptions and have electronic copies to send to
                sellers. With the prescription, a seller would no longer need to submit
                a verification request, which would also benefit prescribers by
                reducing the volume of requests.\614\
                ---------------------------------------------------------------------------
                 \614\ For a more detailed analysis of the reasons the Commission
                allowed prescribers to satisfy the automatic release requirement
                electronically in the Final Rule, see Section II.C.5., supra.
                ---------------------------------------------------------------------------
                 The Commission is also instituting a forty-business-hour
                requirement for prescribers to provide additional copies of
                prescriptions upon request from a patient's agent to ensure that
                patients or their agents can receive additional copies of their
                prescription in a timely manner.\615\ Additionally, prescribers would
                be required to note in the patient's file the name of the requester and
                the date and time the prescription was provided so that the Commission
                is able to determine, if necessary, whether a prescriber has complied
                with the Rule.
                ---------------------------------------------------------------------------
                 \615\ See Section VIII, supra.
                ---------------------------------------------------------------------------
                2. Amendments Affecting Sellers
                 The amendments affecting sellers require them: (1) When using
                automated telephone messages to verify prescriptions, to record the
                entire call (and maintain such recordings for a period of not less than
                three years), commence the call by identifying it as a request for
                prescription verification made in accordance with the Contact Lens
                Rule, deliver the required information in a slow and deliberate manner
                and at a reasonably understandable volume, and make the required
                information repeatable at the prescriber's option; (2) to provide
                consumers with a method that allows consumers to submit their
                prescriptions to sellers; and (3) to verify only the contact lens brand
                or manufacturer that appears on the consumer's prescription, unless the
                consumer has provided an unprescribed contact lens manufacturer or
                brand in response to a specific request from the seller.
                 The Commission implemented the additional requirements for
                automated verification calls to relieve the burden on prescribers and
                reduce potential health risks to patients from incomplete or
                incomprehensible automated telephone messages. Specifically, the
                Commission noted that prescribers must be able to understand automated
                messages so they can, if necessary, respond to sellers to prevent
                improper sales. The Commission imposed the amendments in response to
                concerns about the quality of automated telephone messages, and
                instated the recording requirement because without such a record, the
                Commission cannot reliably assess whether a call was compliant, and
                further, whether the seller has a pattern of placing non-compliant
                calls (and unlawfully selling after such calls).
                 The Commission also imposed a requirement for sellers to accept
                prescription presentation to reduce the number of verifications, reduce
                errors associated with incorrect verification attempts, and make it
                more difficult for ill-intentioned sellers to abuse the passive
                verification framework and take advantage of consumers who might not
                realize that the seller intends to verify a different lens than the one
                written on their prescription.
                 The Commission modified the definition of alteration, and included
                an exception for sellers that verify only the contact lens brand or
                manufacturer that consumers indicate is on their prescriptions in order
                to address the emergence of several businesses that rely exclusively,
                or almost exclusively, on passive verification as a means to substitute
                their own brand of contact lenses for those originally prescribed by
                the patient's prescriber. The Commission continues to receive reports
                about the proliferation of passive verification abuses. The
                implementation of the alteration definition, including the exception,
                should serve as an effective deterrent against sellers that try to game
                the verification system to sell non-prescribed contact lenses.\616\
                ---------------------------------------------------------------------------
                 \616\ The reasons for this Final Rule amendment are more fully
                discussed in Section VI, supra.
                ---------------------------------------------------------------------------
                B. Significant Issues Raised by Public Comments in Response to the
                IRFA, Including Any Comments Filed by the Chief Counsel for Advocacy of
                the Small Business Administration, and the Agency's Response, Including
                Any Changes Made in the Final Rule Amendments
                 The Commission did not receive any comments from the Small Business
                Administration on this Rule Review. The Commission did receive comments
                from various interested parties in response to the SNPRM, and it
                discusses them below.
                1. Amendments Affecting Prescribers
                 As discussed in detail in this notice, the Commission, in the
                SNPRM, determined that the Rule needs to contain some form of patient
                confirmation requirement, but the Commission made changes to its prior
                [[Page 50713]]
                signed-acknowledgment proposal (put forth in the NPRM) in an effort to
                reduce the burden associated with, and address other criticisms
                surrounding, the proposal. These changes included: (1) Adding an option
                for prescribers to satisfy the confirmation requirement by releasing
                the prescription electronically under certain conditions; (2) excluding
                from the requirement eye care prescribers who have no direct or
                indirect financial interest in the sale of contact lenses; and (3)
                allowing prescribers to craft their own wording of the signed
                confirmation, while providing sample confirmation language that
                prescribers can use at their discretion.\617\ In response to the SNPRM
                proposal, the Commission received a number of comments, mostly from
                prescribers, criticizing, and detailing the burden of, and other issues
                associated with complying with, the Commission's Confirmation of
                Prescription Release requirement.\618\
                ---------------------------------------------------------------------------
                 \617\ In the Final Rule, for instances where a patient refuses
                to sign the confirmation, the Commission directs the prescriber to
                note the refusal and preserve this record as evidence of compliance.
                 \618\ See Section II, supra.
                ---------------------------------------------------------------------------
                 Other SNPRM commenters provided new views or concerns about the
                NPRM's proposal to require that prescribers respond to requests from
                patients or their agent for an additional copy of a prescription within
                forty business hours. Some commenters felt that the Commission should
                not impose a time period for prescribers to respond to requests from
                patients or their agents for an additional copy of a prescription.
                Other commenters recommended that the Commission require prescribers to
                respond to such requests within a shorter period of time. The
                Commission has determined that a defined time period is necessary, and
                that its SNPRM proposal of forty business hours should be sufficient to
                ensure prescribers comply within a reasonable amount of time, while at
                the same time limit the additional burden on them to do so.\619\
                ---------------------------------------------------------------------------
                 \619\ These commenters' concerns and the Commission's response
                to such concerns are addressed more fully in Section VIII, supra.
                ---------------------------------------------------------------------------
                2. Amendments Affecting Sellers
                 In response to the SNPRM's proposal to require that each
                verification call: commence by identifying it as a request for
                prescription verification made in accordance with the Contact Lens
                Rule; deliver the required information in a slow and deliberate manner
                and at a reasonably understandable volume; and make the required
                information repeatable at the prescriber's option, the Commission did
                not receive any comments suggesting that this resulted in a burden.
                Some commenters did raise objections, however, to the Commission's
                recording requirement, as discussed in detail in Section III.C., supra.
                For the reasons discussed in that Section and reiterated in A.2. of
                this Section, the Commission determined to retain the recording
                requirement.
                 The Commission did not receive any comments opposing the SNPRM's
                proposal requiring that sellers provide a method of, and a disclosure
                of the method of, prescription presentation. The Commission did receive
                a comment, however, suggesting that the Commission require that the
                method to present prescriptions be in close proximity to the option to
                provide the parameters of the contact lens for verification. Although
                the Commission did not impose that requirement, it took that comment
                into account in determining that, to maximize the potential benefit
                from the amendment, the seller must provide and disclose the method for
                the patient to present the seller with a copy of the patient's
                prescription prior to requesting a prescriber's contact lens
                prescription. In addition, the Commission, in response to comments
                addressing the issue, provided more guidance on the methods that
                sellers need to use (i.e., the method by which the order is taken or
                email, text or file upload).
                 The Commission also received comments on the SNPRM's proposed
                modification defining alteration, and providing an exception to
                alteration for sellers that verify only the brand or manufacturer that
                consumers indicate is on their prescription. Some commenters felt the
                modification was unnecessary, and that other Rule changes were adequate
                to curb the practices of substitution to non-prescribed brands through
                use of the verification system. As addressed in Section VI.B., supra,
                the Commission has determined that there are benefits to retaining this
                modification. In response to comments, however, the Commission provided
                additional guidance on the acceptable methods for obtaining brand and
                manufacturer information.
                C. Description and Estimate of the Number of Small Entities to Which
                the Amendments Will Apply or Explanation Why No Estimate Is Available
                 Prescribers of contact lenses are affected by the amendments
                concerning the option for electronic delivery of prescriptions as a
                means for automatic prescription release, Confirmation of Prescription
                Release, and the imposition of a forty-business-hour time frame for
                responding to authorized requests for additional copies of
                prescriptions. There are approximately 43,000 optometrists and 16,700
                ophthalmologists in the United States,\620\ though not all optometrists
                and ophthalmologists would be affected by the amendments since some do
                not prescribe contact lenses. Some prescribers who prescribe contact
                lenses also would not be affected by the Confirmation of Prescription
                Release requirement if they do not have a direct or indirect interest
                in the sale of contact lenses. Of the contact lens prescribers who are
                affected by the modifications, the Commission--based on its knowledge
                of the eye-care industry--believes that many fall into the category of
                small entities (e.g., offices of optometrists with less than $7.5
                million in average annual receipts).\621\ Determining a precise
                estimate of the number of small entities covered by the Rule's
                prescription-release requirements is not readily feasible, however,
                because most prescribers' offices are private entities that do not
                release the underlying revenue information necessary to make this
                determination.\622\ The Commission sought comment in its SNPRM
                regarding the estimated number or nature of such small business
                entities, if any, for which the proposed amendments would have a
                significant impact, and did not receive commenter guidance in return.
                ---------------------------------------------------------------------------
                 \620\ See note 269, supra.
                 \621\ See U.S. Small Business Admin., ``Table of Small Business
                Size Standards Matched to North American Industry Classification
                System Codes,'' (eff. Feb. 26, 2016), https://www.sba.gov/sites/default/files/files/Size_Standards_Table.pdf.
                 \622\ 5 U.S.C. 601(6).
                ---------------------------------------------------------------------------
                 Non-prescriber sellers of contact lenses are affected by the
                amendments concerning the additional requirements for using an
                automated telephone verification message, requirements to accept
                prescription presentation, and requirements to verify only the contact
                lens brand or manufacturer that consumers indicate is on their
                prescriptions.\623\ Based on its knowledge of the industry, staff
                believes that the number of these entities that likely qualify as small
                businesses (less than $22 million in average annual receipts) is not
                likely to be substantial.\624\
                ---------------------------------------------------------------------------
                 \623\ Most prescribers who sell lenses do so after fitting the
                patient with the prescribed lens, and thus do not rely on
                prescription verification. The amendments affecting sellers pertain
                to verification or prescription presentation and do not pertain to
                these sales. As a result, the Commission does not consider
                prescribers in its estimated burden for the proposals affecting
                sellers.
                 \624\ See U.S. Small Business Admin., ``Table of Small Business
                Size Standards Matched to North American Industry Classification
                System Codes'' (Aug. 19, 2019), https://www.ecfr.gov/cgi-bin/text-idx?SID=b919ec8f32159d9edaaa36a7eaf6b695amp;mc=true&node=pt13.1.121&r
                gn=div5#se13.1.121_1201.
                ---------------------------------------------------------------------------
                [[Page 50714]]
                D. Description of the Projected Reporting, Recordkeeping and Other
                Compliance Requirements of the Amendments, Including an Estimate of the
                Classes of Small Entities That Will Be Subject to the Requirement and
                the Type of Professional Skills Necessary for Preparation of the Report
                or Record
                1. Amendments Affecting Prescribers
                 The Confirmation of Prescription Release amendment requires that
                prescribers with a direct or indirect interest in the sale of contact
                lenses request that patients sign, and maintain for a period of not
                less than three years, either (A) a statement confirming receipt of the
                contact lens prescription; (B) a prescriber-retained copy of a contact
                lens prescription that contains a statement confirming receipt of the
                contact lens prescription; or (C) a prescriber-retained copy of the
                receipt for the examination that contains a statement confirming
                receipt of the contact lens prescription.
                 As an alternative to (A), (B), and (C), under certain conditions,
                prescribers can provide a contact lens prescription digitally. In order
                to avail themselves of this option, prescribers must maintain, for a
                period of not less than three years, evidence that the prescriptions
                were sent, received, or made accessible, downloadable and printable. In
                addition, the prescriber must identify to the patient the specific
                method or methods of electronic delivery to be used, such as text
                message, electronic mail, or an online patient portal, obtain the
                patient's verifiable affirmative consent to receive a digital copy
                through the identified method or methods, and maintain records or
                evidence of a patient's affirmative consent for a period of not less
                than three years.
                 The small entities potentially covered by these amendments will
                include all such entities subject to the Rule. The professional skills
                necessary for compliance with the Rule as modified will include office
                and administrative support supervisors to create the language and
                format of the confirmation, and clerical personnel to collect
                signatures from patients and maintain records, or in the case of
                digital prescriptions, retain evidence that the prescription was sent,
                received, or made accessible, downloadable and printable and retain
                evidence of a patient's affirmative consent. Compliance may include
                some minimal training time as well. The Commission has provided
                language that prescribers can use for the Confirmation of Prescription
                Release which, should a prescriber elect to use such language, negates
                the burden of formulating appropriate language. The Commission believes
                the overall burden imposed on small businesses by these requirements is
                relatively small, for the reasons described previously in Section
                II.C.7. of this notice. That section also addresses in detail the
                comments received, which discuss the burden from this amendment.
                 The amendment relating to providing a designated agent with an
                additional copy of a prescription requires that the prescriber respond
                within forty business hours of receipt of the request, and note in the
                patient's record the name of the requester and the date and time that
                the prescription was provided to the requester. The professional skills
                necessary for compliance with this amendment will include office and
                administrative support staff to respond to the request within forty
                business hours. Previously, office and administrative support staff
                were already required to respond to such requests, just not within a
                specific time frame. The forty-business-hour time period, in and of
                itself, should not impose a significant new burden. The office and
                administrative support staff will also need to make the required
                notations in the patient's records. As noted, the required notation
                would be limited to the name of the requester and the date and time the
                prescription was provided to the requester. Although the Rule does not
                require that prescribers retain the notations, the Commission expects
                prescribers would make and retain such notations in the ordinary course
                of their business and thus believes the proposal would not create much,
                if any, additional burden.
                2. Amendments Affecting Sellers
                 To the extent, if any, that non-prescriber sellers are small
                entities, the amendments relating to changes in verifications made
                through automated telephone messages require sellers to record the
                entire call, commence the call by identifying it as a request for
                prescription verification made in accordance with the Rule, deliver the
                information in a slow and deliberate manner and at a reasonably
                understandable volume, and make the information repeatable at the
                prescriber's option. Sellers must retain the complete call recording of
                such automated telephone messages for at least three years.
                 The Commission believes that most small sellers who are covered by
                the Rule, if any, are unlikely to have undergone or to undergo the
                expense associated with creating and maintaining an automated telephone
                system for verification requests.\625\ Instead, the Commission believes
                that small sellers typically comply with the Rule by receiving copies
                of prescriptions from patients, or making verification requests to
                prescribers via fax, email, or telephone calls using ``live'' agents.
                If a small seller already has an automated system for verification, the
                Commission does not believe the costs to accommodate the changes would
                be more than minimal, if any. For a seller who was following the FTC's
                prior guidance that automated messages be delivered at a volume and
                cadence that a reasonable person can understand,\626\ it already
                complies with the new proposal that all such messages be at a
                ``reasonably understandable volume'' and delivered in a ``slow and
                deliberate manner.'' Similarly, if not already in compliance, a seller
                might need to modify its model verification recording to identify at
                the start that a call is being made in accordance with the Contact Lens
                Rule and to make the required information repeatable at the
                prescriber's option.
                ---------------------------------------------------------------------------
                 \625\ 1-800 CONTACTS also believes this to be the case. See 1-
                800 CONTACTS (SNPRM Comment #135) (stating that the number of
                sellers that use this particular technology is likely limited).
                 \626\ Prior guidance from the FTC directed sellers to deliver
                verification messages at a volume and cadence that a reasonable
                person can understand. See note 301, supra.
                ---------------------------------------------------------------------------
                 The Commission also has little reason to believe that the new
                requirement that sellers who use automated messages record such calls
                and retain them for no less than three years creates a substantial
                burden for small sellers. The Commission's SNPRM invited comment on the
                frequency with which small sellers use automated telephone messages for
                verification and the costs associated with the proposals pertaining to
                these messages, including whether existing verification systems include
                the capability to record and the capacity for storage, and the costs
                associated with recording the calls and maintaining the recordings for
                no less than three years. The Commission received little guidance in
                response. 1-800 CONTACTS, a large contact lens seller, stated the
                proposal to record and store these calls imposes a ``costly'' burden,
                but did not detail the costs associated with recording and maintaining
                the calls. The Commission's own research surrounding such costs for
                recording phone calls does not support this contention.\627\ And as
                noted above, the
                [[Page 50715]]
                number of sellers that employ this technology is limited, and the
                Commission does not believe that small sellers use or are likely to use
                automated messages for verification calls.
                ---------------------------------------------------------------------------
                 \627\ See PRA discussion of the cost of recording calls, Section
                XI.B., supra.
                ---------------------------------------------------------------------------
                 The new requirement that sellers provide a method, and a clear and
                prominent disclosure of the method, for the consumer to present the
                seller with a copy of the patient's prescription also does not impose a
                large burden on small sellers. A small seller would need to update its
                website or other consumer interface to inform consumers about the
                ability to provide the seller with a prescription, or alternatively, if
                an order occurs via telephone or in person, to verbally inform the
                consumer about the ability to provide the seller with a prescription.
                The professional skill or time necessary for this task would include
                personnel with the skills required to update the website or other
                consumer interface, and the time it takes to make the updates, or if
                the information is relayed over the phone or in person, the additional
                time for an employee or agent of the seller to inform a consumer that
                he or she is able to provide a prescription, and of the method by which
                a consumer can do so. These proposals may also require training time
                for staff. The seller would also need to provide a mechanism for a
                consumer to provide the prescription to the seller. Because a small
                seller almost certainly already has the capacity to accept
                prescriptions via an existing electronic system or email account, the
                Commission believes there is little additional burden of complying with
                this part of the proposal.
                 The small seller would also need to maintain prescriptions it
                receives via patient presentation. The Commission has not received any
                comments that alter its understanding that such retention does not
                create more than a minimal burden. Further, by retaining a patient's
                prescription, a seller is relieved of the burden to verify that
                prescription or maintain records of verification. As a result, the
                burden from obtaining and retaining prescriptions likely offsets the
                burden from making verification requests and storing records of such
                requests.
                 Both the FCLCA and the Rule prohibit illegal alteration of a
                prescription. The modification of the Rule's definition of alteration
                would clarify what constitutes alteration, and permit sellers to avail
                themselves of an exception by verifying only the contact lens brand or
                manufacturer that consumers indicate is on their prescriptions when
                asked by the seller. As a result, all non-prescriber sellers that
                qualify as small businesses would need to request and obtain
                manufacturer or brand information via website or other consumer
                interface, telephone, or in person to qualify for the exception. The
                professional skill or time necessary for this task would include
                personnel with the skills required to update the website or other
                consumer interface and the time it takes to make the updates, or if the
                information is relayed over the phone or in person, the additional time
                for an employee or agent of the seller to obtain the information. Such
                employees would also need to be trained on this requirement.
                 Although there is no associated document retention requirement set
                forth in the Rule, the Commission is aware that without the evidence
                that the manufacturer or brand provided on the verification request was
                the one provided by the customer, the seller would not be able to avail
                itself of the exception to illegal alteration. As a result, the
                Commission has considered the associated document retention as a new
                burden. However, since many contact lens sales by non-prescriber
                sellers occur online, the burden of such record retention may be
                minimized by the ability to keep electronic sales records. For sales
                that occur via telephone or in person, the seller would be required to
                maintain records of the request made by, and the information supplied
                by, the consumer. The Commission believes that sellers retain phone-
                order records in the ordinary course of business and any additional
                recordkeeping sellers may do to qualify for the exception is likely to
                be minimal.
                E. Steps Taken To Minimize the Significant Impact, if Any, of the
                Amendments, Including Why Any Significant Alternatives Were Not Adopted
                1. Steps and Alternatives for Amendments Affecting Prescribers
                 The Commission considered a number of alternatives to the
                requirement for prescribers to request the patient sign a confirmation
                of receipt of a contact lens prescription, including signage and
                educating consumers about their rights to a contact lens prescription.
                The Commission determined that signage would be significantly less
                effective than a Confirmation of Prescription Release requirement. It
                also determined that consumer education in itself, whether provided via
                information entry forms, a patients' bill of rights, advertising, or
                public service announcements, would not have a significant impact on
                prescriber compliance with automatic prescription release, and would
                not increase the Commission's ability to monitor and enforce the
                Rule.\628\ In response to commenter concerns about its proposal as
                outlined in the NPRM and SNPRM, the Commission took steps to minimize
                the impact of the Confirmation of Prescription Release. First, the
                Commission included an option for prescribers to satisfy the
                confirmation by releasing the prescription electronically. While not
                every prescriber will be able to use this option to deliver a
                prescription electronically, the Commission is confident that this
                option will still reduce the burden for many, especially as more
                prescribers move toward electronic recordkeeping. Second, the
                Commission excluded from the requirement eye care prescribers who have
                no direct or indirect financial interest in the sale of contact lenses.
                By more narrowly targeting the requirement to only those with an
                incentive to withhold prescriptions, the Commission further reduced the
                overall burden and avoided unnecessarily impacting prescribers who are
                unlikely to violate the Rule. Third, the Commission reduced the burden
                by allowing a significant degree of flexibility in how prescribers
                comply with the confirmation requirement. The Final Rule allows
                prescribers to craft their own wording for statements confirming
                receipt of contact lens prescriptions (on a stand-alone statement, on a
                prescriber-retained copy of a prescription, or on a prescriber-retained
                copy of an examination receipt), while providing sample language for
                prescribers to use, should they not wish to formulate their own
                confirmation. This change reduces the possible paperwork burden and
                limits potential interference with the prescriber-patient
                relationship.\629\
                ---------------------------------------------------------------------------
                 \628\ These alternatives and the reasons the Commission found
                them to be insufficient alternatives to Confirmation of Prescription
                Release are more fully described in Section II.C.6., supra, of this
                notice.
                 \629\ In the Final Rule, for instances where a patient refuses
                to sign the confirmation, the Commission directs the prescriber to
                note the refusal and preserve this record as evidence of compliance.
                ---------------------------------------------------------------------------
                 In considering the amendment requiring prescribers to respond to
                requests for copies of a prescription within a defined period (forty
                business hours), the Commission considered, but rejected, the option to
                simply rely on the expectation that all prescribers would fulfill their
                responsibilities to their patients. It is the Commission's
                understanding that prescribers do not always comply, or comply
                expediently, and therefore believes the time-limit requirement is
                necessary. In order to minimize the burden on prescribers, however, the
                Commission rejected
                [[Page 50716]]
                commenter requests to make the time limit significantly shorter, such
                as eight business hours. As for the new requirement that prescribers
                make a notation in the patient's record when responding to such
                requests, the Commission declined to shift the recordkeeping burden to
                the designated agent making a request because, to determine whether a
                particular prescriber is complying with the Rule, the Commission would
                need to obtain records from a wide variety of agents.
                2. Steps and Alternatives for Amendments Affecting Sellers
                 The Commission did not consider specific alternatives to the Final
                Rule's requirement that sellers, when using automated telephone
                messages to verify prescriptions, commence the call by identifying it
                as a request for prescription verification made in accordance with the
                Contact Lens Rule, deliver the required information in a slow and
                deliberate manner and at a reasonably understandable volume, and make
                the required information repeatable at the prescriber's option.\630\
                The Commission included these amendments in the Final Rule to relieve
                the burden on prescribers and reduce potential health risks to patients
                from incomplete or incomprehensible automated telephone messages.
                Specifically, the Commission noted that prescribers must be able to
                understand automated messages so they can, if necessary, respond to
                sellers to prevent improper sales. Commenters presented additional
                suggestions to improve call quality, but did not suggest alternatives
                to commencing the call by identifying it as a request for prescription
                verification made in accordance with the Contact Lens Rule, and to make
                the required information repeatable at the prescriber's option, nor did
                they express opposition to such requirements.
                ---------------------------------------------------------------------------
                 \630\ The requirements that the seller deliver the required
                information in a slow and deliberate manner and at a reasonably
                understandable volume have been part of the FTC's prior guidance
                that the information be delivered at a volume and cadence that a
                reasonable person can understand.
                ---------------------------------------------------------------------------
                 The Commission considered whether to require sellers to retain a
                sample recording of the standard script leaving blanks for prescription
                and patient details instead of recording all calls using automated
                telephone messages. However, the Commission determined that a script or
                a sample recording would not reveal whether the required information
                was transmitted effectively or if, for instance, it was transmitted
                before a representative or machine answered, after an answering machine
                cut off, when a prescriber's office put the call on hold, or over hold
                music, in which case the call could not be used as a basis for the
                sale. In addition, a script or sample recording would not permit the
                Commission to assess whether a particular call was delivered in a
                ``slow and deliberate manner'' and at a ``reasonable understandable
                volume.'' Without knowing this information, the Commission would be
                unable to determine conclusively whether any particular verification
                request was valid. Therefore, the Commission did not adopt this
                recommendation.
                 With respect to the requirement that sellers accept prescription
                presentation, the Commission did not receive any comments opposing this
                proposal, and thus did not consider alternatives. In response to
                commenter concerns, however, the Commission determined not to permit
                sellers to select any method of communication, but opted instead to
                maximize the benefits from the amendment by requiring the seller to
                present the prescription through the same medium by which the order is
                placed, or electronic mail, text message, or file upload.
                 For verification requests, the Commission expressly defined
                alteration as occurring when sellers provide prescribers with the name
                of a manufacturer or brand other than that specified on a patient's
                prescription. However, the Commission provided an exception such that
                it would not amount to alteration in instances when sellers verify only
                the contact lens brand or manufacturer that consumers indicate is on
                their prescriptions after a seller requests that information. As
                possible alternatives to these changes, the Commission considered
                whether it could instead rely on the new requirements that sellers (a)
                provide a method for prescription presentation and (b) meet quality
                standards for verification calls, but the Commission determined that
                those requirements alone are inadequate to curb the practice of
                unlawful substitution to non-prescribed brands through abuse of the
                verification system. Although the Commission has previously stated that
                a verification request is not valid and does not commence the eight-
                business-hour verification period if a seller knows or should know that
                the verification request includes a different brand and manufacturer
                than that prescribed, the FTC continues to receive reports about the
                proliferation of passive verification abuses, and sellers ``gaming the
                system'' to substitute a different brand or manufacturer. Furthermore,
                without the changes to the definition of alteration, sellers may argue
                that they are technically compliant with the Rule because they
                submitted verification requests and prescribers had an opportunity to
                respond to the requests, and may also argue that they did not have
                knowledge that a consumer did not have a prescription for that
                manufacturer or brand of lens. The Final Rule amendment will give them
                a basis of knowledge by requesting that a consumer state the brand or
                manufacturer of her brand of lens. Additionally, the Commission
                determined that without the express definition of alteration and the
                exception thereto, enforcement would not, in and of itself, be adequate
                to protect consumers, because alteration via abuse of the verification
                system does not occur with only one bad actor, and because of an
                increase in companies that appear to alter prescriptions in this way.
                 Seller 1-800 CONTACTS also commented that the amendment should not
                refer to ``brand'' as that language does not appear elsewhere in the
                Rule. It pointed out that the Rule defines a prescription as including
                a ``material or manufacturer or both'' and that the Commission's
                inclusion of the reference to brand imposes an additional limit on
                consumer choice that is not required by the Act. 1-800 CONTACTS
                requested that the exception to the Rule be applicable to ``providing
                the prescriber with the name of a manufacturer or material other than
                that specified by the patient's prescriber . . . .'' The reference to
                brand in the definition of alteration and in the exception are the only
                references to brand in the Rule. However, because many, if not most,
                prescriptions list the manufacturer's brand, not the manufacturer or
                material, and very few consumers know the manufacturer or material of
                contact lens that they wear (typically referring to their lenses by
                brand name), the Commission declines to follow 1-800 CONTACTS'
                recommendation because many consumers would be unable to respond to a
                seller's request.
                 1-800 CONTACTS expressed concern that the Commission's amendment
                might interfere with its ability to improve the user experience. It
                indicated that it sells hundreds of brands of lenses and offers
                consumers a variety of methods to identify their brand, including drop-
                down menus, a search box, and filters that display lenses by brand,
                modality, and other parameters and that some consumers do not enter
                their brand information on an order form. In response, the Commission,
                in the Final Rule, removed the language from its earlier proposal that
                sellers must obtain the information
                [[Page 50717]]
                on ``an order form.'' In comparison, other commenters requested greater
                specificity or even prohibitions on the acceptable mechanisms for
                sellers to request and consumers to select their brand. In response,
                the Commission clarified that, at a minimum, in order for sellers to
                consider the consumer's indication of manufacturer or brand as adequate
                to qualify for the exception, the manufacturer or brand must be: (1)
                Provided in response to a seller's request for the manufacturer or
                brand listed on the consumer's prescription; and (2) an affirmative
                statement or selection by the consumer, not a preselected or prefilled
                entry.\631\
                ---------------------------------------------------------------------------
                 \631\ See Section VI.B., supra.
                ---------------------------------------------------------------------------
                XIII. Congressional Review Act
                 Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
                the Office of Information and Regulatory Affairs designated these rule
                amendments as not a ``major rule,'' as defined by 5 U.S.C. 804(2).
                List of Subjects in 16 CFR Part 315
                 Advertising, Medical devices, Ophthalmic goods and services, Trade
                practices.
                 For the reasons discussed in the preamble, the Federal Trade
                Commission amends title 16 of the Code of Federal Regulations, part
                315, as follows:
                PART 315--CONTACT LENS RULE
                0
                1. The authority for part 315 is revised to read as follows:
                 Authority: 15 U.S.C. 7601-7610.
                0
                2. Amend Sec. 315.2 by adding in alphabetical order the definitions of
                ``Provide to the patient a copy'', ``Reasonably understandable volume''
                and ``Slow and deliberate manner'' to read as follows:
                Sec. 315.2 Definitions.
                * * * * *
                 Provide to the patient a copy means giving a patient a copy of his
                or her contact lens prescription:
                 (1) On paper; or
                 (2) In a digital format that can be accessed, downloaded, and
                printed by the patient. For a copy provided in a digital format, the
                prescriber shall identify to the patient the specific method or methods
                of electronic delivery to be used, such as text message, electronic
                mail, or an online patient portal, and obtain the patient's verifiable
                affirmative consent to receive a digital copy through the identified
                method or methods; and maintain records or evidence of a patient's
                affirmative consent for a period of not less than three years. Such
                records or evidence shall be available for inspection by the Federal
                Trade Commission, its employees, and its representatives.
                 Reasonably understandable volume means at an audible level that
                renders the message intelligible to the receiving audience.
                 Slow and deliberate manner means at a rate that renders the message
                intelligible to the receiving audience.
                0
                3. Amend Sec. 315.3 by:
                0
                a. Revising paragraphs (a)(1) and (2);
                0
                b. Adding paragraph (a)(3);
                0
                c. Revising paragraphs (b)(1) through (3); and
                0
                d. Adding paragraph (c).
                 The additions and revisions read as follows:
                Sec. 315.3 Availability of contact lens prescriptions to patients.
                 (a) In general. When a prescriber completes a contact lens fitting,
                the prescriber:
                 (1) Whether or not requested by the patient, shall provide to the
                patient a copy of the contact lens prescription;
                 (2) Shall, as directed by any person designated to act on behalf of
                the patient, verify the contact lens prescription by electronic or
                other means; and
                 (3) Shall, upon request, provide any person designated to act on
                behalf of the patient with a copy of the patient's contact lens
                prescription by electronic or other means within forty (40) business
                hours of receipt of the request. A prescriber shall note in the
                patient's record the name of the requester and the date and time that
                the prescription was provided to the requester.
                 (b) Limitations. A prescriber may not:
                 (1) Require the purchase of contact lenses from the prescriber or
                from another person as a condition of providing a copy of a
                prescription under paragraph (a)(1) or (a)(3) of this section or as a
                condition of verification of a prescription under paragraph (a)(2) of
                this section;
                 (2) Require payment in addition to, or as part of, the fee for an
                eye examination, fitting, and evaluation as a condition of providing a
                copy of a prescription under paragraph (a)(1) or (a)(3) of this section
                or as a condition of verification of a prescription under paragraph
                (a)(2) of this section; or
                 (3) Require the patient to sign a waiver or release as a condition
                of releasing or verifying a prescription under paragraph (a)(1),
                (a)(2), or (a)(3) of this section.
                 (c) Confirmation of prescription release. (1)(i) Upon completion of
                a contact lens fitting, the prescriber shall do one of the following:
                 (A) Request that the patient acknowledge receipt of the contact
                lens prescription by signing a statement confirming receipt of the
                contact lens prescription;
                 (B) Request that the patient sign a prescriber-retained copy of a
                contact lens prescription that contains a statement confirming receipt
                of the contact lens prescription;
                 (C) Request that the patient sign a prescriber-retained copy of the
                receipt for the examination that contains a statement confirming
                receipt of the contact lens prescription; or
                 (D) If a digital copy of the prescription was provided to the
                patient (via methods including an online portal, electronic mail, or
                text message) in compliance with paragraph (a)(1) of this section,
                retain evidence that the prescription was sent, received, or made
                accessible, downloadable, and printable.
                 (ii) If the prescriber elects to confirm prescription release via
                paragraphs (c)(1)(i)(A), (B), or (C) of this section, the prescriber
                may, but is not required to, use the statement, ``My eye care
                professional provided me with a copy of my contact lens prescription at
                the completion of my contact lens fitting'' to satisfy the requirement.
                 (iii) In the event the patient declines to sign a confirmation
                requested under paragraph (c)(1)(i)(A), (B), or (C) of this section,
                the prescriber shall note the patient's refusal on the document and
                sign it.
                 (2) A prescriber shall maintain the records or evidence required
                under paragraph (c)(1) of this section for a period of not less than
                three years. Such records or evidence shall be available for inspection
                by the Federal Trade Commission, its employees, and its
                representatives.
                 (3) Paragraphs (c)(1) and (c)(2) of this section shall not apply to
                prescribers who do not have a direct or indirect financial interest in
                the sale of contact lenses, including, but not limited to, through an
                association, affiliation, or co-location with a contact lens seller.
                0
                4. Amend Sec. 315.5 by:
                0
                a. Redesignating paragraphs (d), (e), (f), and (g) as paragraphs (e),
                (f), (h), and (i), respectively;
                0
                b. Adding new paragraph (d);
                0
                c. Revising newly redesignated paragraph (f);
                0
                d. Adding new paragraph (g);
                0
                e. Adding new paragraph (h)(2)(iii);
                0
                f. Revising newly redesignated paragraph (i).
                 The additions and revisions read as follows:
                [[Page 50718]]
                Sec. 315.5 Prescriber verification.
                * * * * *
                 (d) Automated telephone verification messages. If a seller verifies
                prescriptions through calls that use, in whole or in part, an automated
                message, the seller must:
                 (1) Record the entire call;
                 (2) Commence the call by identifying it as a request for
                prescription verification made in accordance with the Contact Lens
                Rule;
                 (3) Deliver the information required by paragraph (b) of this
                section in a slow and deliberate manner and at a reasonably
                understandable volume; and
                 (4) Make the information required by paragraph (b) of this section
                repeatable at the prescriber's option.
                * * * * *
                 (f) No alteration of prescription. A seller may not alter a contact
                lens prescription. In the context of prescription verification,
                alteration includes, but is not limited to, providing the prescriber
                with the name of a manufacturer or brand other than that specified by
                the patient's prescription, unless such name is provided because the
                patient entered or orally provided it when asked for the manufacturer
                or brand listed on the patient's prescription. Notwithstanding the
                preceding sentences, for private label contact lenses, a seller may
                substitute for contact lenses specified on a prescription identical
                contact lenses that the same company manufactures and sells under
                different labels.
                 (g) Seller requirement to accept prescription presentation: A
                seller shall provide a prominent method, and a clear and prominent
                disclosure of that method, for the patient to present the seller with a
                copy of the patient's prescription. Such method and the disclosure
                shall be provided prior to requesting a prescriber's contact
                information for verification of the prescription; provided, however, in
                the case of an order placed by telephone, a seller shall comply by
                providing a disclosure of the method prior to requesting a prescriber's
                contact information for verification of the prescription. The method to
                present the prescription shall be provided through (i) the same medium
                by which the order is placed, or (ii) electronic mail, text message, or
                file upload.
                 (h) * * *
                 (2) * * *
                 (iii) If the communication occurs via telephone and uses an
                automated message, the complete recording required pursuant to
                paragraph (d)(1) of this section.
                * * * * *
                 (i) Recordkeeping requirement--Saturday business hours. A seller
                that exercises its option to include a prescriber's regular Saturday
                business hours in the time period for a request for a copy of the
                prescription specified in Sec. 315.3(a)(3) or for verification
                specified in paragraph (c)(3) of this section shall maintain a record
                of the prescriber's regular Saturday business hours and the basis for
                the seller's actual knowledge thereof. Such records shall be maintained
                for a period of not less than three years, and these records must be
                available for inspection by the Federal Trade Commission, its
                employees, and its representatives.
                 By direction of the Commission.
                April J. Tabor,
                Secretary.
                [FR Doc. 2020-14206 Filed 8-14-20; 8:45 am]
                BILLING CODE 6750-01-P
                

VLEX uses login cookies to provide you with a better browsing experience. If you click on 'Accept' or continue browsing this site we consider that you accept our cookie policy. ACCEPT