# Contact Lens Rule > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3A2020-14206 ## Record - **Collection:** Federal Register - **Document type:** Rule - **Published:** August 17, 2020 - **Citation:** 85 FR 50668 ## Text 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), abernstein@ftc.gov, Paul Spelman (202-326-2487), pspelman@ftc.gov, or Andrew Wone (202-326-2934), awone@ftc.gov, 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 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, 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.”). 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 § 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 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 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 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. 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 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 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 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 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 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 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 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 [Text truncated at 120,000 characters. The full text is on the page linked above.] --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A2020-14206. Public record. Not legal advice.