# Ophthalmic Practice Rules (Eyeglass Rule) > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3A2022-27828 ## Record - **Collection:** Federal Register - **Document type:** Proposed Rule - **Published:** January 3, 2023 - **Citation:** 88 FR 248 ## Text FEDERAL TRADE COMMISSION 16 CFR Part 456 RIN 3084-AB37 Ophthalmic Practice Rules (Eyeglass Rule) AGENCY: Federal Trade Commission. ACTION: Notice of proposed rulemaking; request for public comment. SUMMARY: The Federal Trade Commission (“FTC” or “Commission”) proposes to amend the Ophthalmic Practice Rules (“Eyeglass Rule ” or “Rule”) to require that prescribers obtain a signed confirmation after releasing an eyeglass prescription to a patient, and maintain each such confirmation for a period of not less than three years. The Commission also proposes to permit prescribers to comply with automatic prescription release via electronic delivery in certain circumstances. The Commission further proposes a clarification that the presentation of proof of insurance coverage shall be deemed to be a payment for the purpose of determining when a prescription must be provided. Finally, the Commission proposes to amend the term “eye examination” to “refractive eye examination” throughout the Rule. The Commission seeks comment on these proposals. DATES: Written comments must be received on or before March 6, 2023. ADDRESSES: Interested parties may file a comment online or on paper by following the instructions in the Request for Comment part of the SUPPLEMENTARY INFORMATION section below. Write “Eyeglass Rule, Project No. R511996” on your comment, and file your comment through https://www.regulations.gov. If you prefer to file your comment on paper, write “Eyeglass Rule, Project No. R511996” on your comment and on the envelope and mail your comment to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW, Suite CC-5610 (Annex C), Washington, DC 20580. FOR FURTHER INFORMATION CONTACT: Alysa Bernstein, Attorney, (202) 326-3289, Paul Spelman, Attorney, (202) 326-2487, or Sarah Botha, Attorney, (202) 326-2036, Division of Advertising Practices, Bureau of Consumer Protection, Federal Trade Commission, 600 Pennsylvania Avenue NW, Washington, DC 20580. SUPPLEMENTARY INFORMATION: The Commission finds that using the procedures set forth in this notice of proposed rulemaking will serve the public interest by supporting the Commission's goals of clarifying and updating existing regulations without undue expenditure of resources, while ensuring that the public has an opportunity to submit data, views, and arguments on whether the Commission should amend the Rule. The Commission, therefore, has determined, pursuant to 16 CFR 1.20, to use the following procedures: (1) publishing this notice of proposed rulemaking; (2) soliciting written comments on the Commission's proposals to amend the Rule; (3) holding a workshop; and (4) announcing final Commission action in a document to be published in the Federal Register . The Commission will host a workshop to gather additional public input regarding the proposed changes. After publishing this notice of proposed rulemaking (“NPRM”), the Commission will publish a document in the Federal Register announcing the workshop and providing instructions on how interested persons may request an opportunity to participate. The Commission, in its discretion, has not chosen to schedule an informal hearing and has not made any initial designations of disputed issues of material fact necessary to be resolved at an informal hearing. The Commission believes that a workshop will provide sufficient opportunity for obtaining additional public input on its proposal. Interested persons who wish to make an oral submission at an informal hearing must file a comment in response to this NPRM and submit a statement identifying their interests in the proceeding and describing any proposals regarding the designation of disputed issues of material fact to be resolved at the informal hearing, on or before March 6, 2023. 16 CFR 1.11. Such requests, and any other motions or petitions in connection with this proceeding must be filed with the Secretary of the Commission. Table of Contents I. Background A. Overview of the Eyeglass Rule B. History of the Rule 1. Eyeglass I Report and Rule 2. Eyeglass II Report and Rule 3. The 1997 to 2004 Eyeglass Rule Review 4. The 2015 to 2020 Contact Lens Rule Review C. The Evolving Eyeglass Marketplace D. State Regulation of the Sale of Eyeglasses II. Eyeglass Rule Review A. Evidentiary Standard B. Overview of Comments in Response to ANPR III. Requirements for Eyeglass Sellers IV. Section 456.2—Separation of Examination and Dispensing A. Automatic Prescription Release 1. Comments on Whether To Retain Automatic Prescription Release 2. Compliance With the Automatic Prescription Release Requirement 3. Evidence Regarding Consumers' Awareness of Their Right To Receive Their Prescription 4. Analysis of Evidence Regarding Automatic Prescription Release Provision 5. Proposals for Improving Compliance and Consumer Awareness a. Proposal To Increase Enforcement b. Proposal To Require an Eye Care Patients' Bill of Rights c. Proposal To Require Signage d. Proposal To Require a Confirmation of Prescription Release 6. The Commission's Proposal To Require a Signed Confirmation of Prescription Release B. Other Issues Surrounding Patients' Access To Eyeglass Prescriptions 1. Prescriber Responsibilities To Provide Additional Copies of Prescriptions a. Analysis of Whether To Require Provision of Additional Copies of Prescriptions Upon Request b. Analysis of Whether To Permit Prescribers to Charge Fees for Provision of Additional Copies of Prescriptions 2. Electronic Delivery of Prescriptions as a Means for Automatic Prescription Release Under Section 456.2(a) a. The Commission's Proposal To Add a Definition to Section 456.1 To Permit Electronic Delivery of the Patient's Prescription b. Technological Advances That May Improve Prescription Portability c. HIPAA Concerns Regarding Emailed Prescriptions 3. Insurance Coverage as Payment Under Section 456.2(a) C. Requiring Prescribers To Respond to Authorized Third-Party Seller Requests for a Copy of Prescription or Verification of Prescription Information 1. Comments on Requiring Prescriber Response to Third-Party Seller Requests 2. Analysis of Whether To Amend the Rule to Require Prescriber Response V. Prescription Requirements A. Requiring Prescribers To Include Pupillary Distance on Eyeglass Prescriptions 1. Comments on Whether To Require Pupillary Distance 2. Analysis of Whether to Amend the Rule To Require Pupillary Distance B. Amending the Rule To Set an Expiration Date for Eyeglass Prescriptions C. Amending Other Rule Definitions VI. Recommendations Regarding the Commission's Complaint System VII. Request for Comment VIII. Communications by Outside Parties to the Commissioners or Their Advisors IX. Paperwork Reduction Act A. Estimated Burden B. Estimated Labor Cost C. Capital and Other Non-Labor Costs X. Preliminary Regulatory Analysis and Regulatory Flexibility Act Requirements A. Description of the Reasons the Agency Is Taking Action B. Statement of the Objectives of, and Legal Basis for, the Proposed Amendments C. Small Entities to Which the Proposed Amendments Will Apply D. Projected Reporting, Recordkeeping, and Other Compliance Requirements, Including Classes of Covered Small Entities and Professional Skills Needed To Comply E. Duplicative, Overlapping, or Conflicting Federal Rules F. Significant Alternatives to the Proposed Amendments Proposed Rule Language I. Background A. Overview of the Eyeglass Rule The Eyeglass Rule declares it an unfair practice for an optometrist or ophthalmologist to fail to provide a patient with a copy of the patient's eyeglass prescription immediately after an eye examination is completed. 1 The prescriber may not charge the patient any fee in addition to the prescriber's examination fee as a condition to releasing the prescription to the patient. 2 The Rule defines a prescription as the written specifications for lenses for eyeglasses which are derived from an eye examination, including all of the information specified by state law, if any, necessary to obtain lenses for eyeglasses. 3 1 16 CFR 456.2(a). A prescriber may withhold a patient's prescription until the patient has paid for the eye examination, but only if the prescriber would have required immediate payment if the examination had revealed that no ophthalmic goods were needed. Id. 2 16 CFR 456.2(c). 3 16 CFR 456.1(g). The Rule prohibits an optometrist or ophthalmologist from conditioning the availability of an eye examination on a requirement that the patient agree to purchase ophthalmic goods from the ophthalmologist or optometrist. 4 The Rule also deems it an unfair act or practice for the prescriber to place on the prescription, or require the patient to sign, or deliver to the patient, a waiver or disclaimer of prescriber liability or responsibility for the accuracy of the exam or the ophthalmic goods and services dispensed by another seller. 5 4 16 CFR 456.2(b). The Rule thereby also prohibits conditioning the release of the prescription on the requirement that the patient purchase ophthalmic goods from the ophthalmologist or optometrist. 5 16 CFR 456.2(d). B. History of the Rule The FTC has decades of regulatory and research experience with the optical goods industry, which continues to inform the basis and purpose of the Rule and this NPRM. The Commission's engagement in the industry predates formal adoption of the Eyeglass Rule. In 1962, the Commission first took steps to protect consumers and foster competition in the sale of eyeglasses by adopting the “Guides for the Optical Products Industry,” which included a provision declaring it an unfair trade practice to “tie in or condition” refraction services to the dispensing of eyeglasses when such a practice has a “reasonable probability” of harming competition. 6 Among the conduct considered unfair were charging a higher or additional fee if the patient wanted to take the prescription elsewhere to buy eyeglasses, and refusing to perform examinations if the patient wanted to take the prescription elsewhere. 7 The Guides were not binding, however, and the FTC never undertook litigation to enforce them, 8 even though prescribers routinely violated the directives. 9 6 16 CFR 192 (rescinded); see also “Staff Report on Advertising of Ophthalmic Goods and Services and Proposed Trade Regulation Rule,” 235-36 (1977), https://www.ftc.gov/reports/staff-report-advertising-ophthalmic-goods-services-proposed-trade-regulation-rule-16-cfr-part-456?msclkid=957f749bc63711ecaefb4944debc75db [hereinafter Eyeglass I Report]. 7 Eyeglass I Report, supra note 6, at 235-36. 8 Id. 9 See id. at 240-48 (detailing myriad accounts of prescribers refusing to release eyeglass prescriptions to their patients); see also Final Trade Regulation Rule, Advertising of Ophthalmic Goods and Services, 43 FR 23992, 23998 (June 2, 1978) [hereinafter Eyeglass I Rule] (finding that in nearly every survey of practicing optometrists considered in the rulemaking record, more than 50 percent imposed a restriction on the availability of eyeglass prescriptions to patients). 1. Eyeglass I Report and Rule On September 16, 1975, the Commission directed its staff to examine the retail ophthalmic market, including whether prescribers were tying eyeglass dispensing to examination, and whether such practices harmed consumers. 10 Staff surveyed state laws and regulations, and solicited comment from a variety of interested parties, including ophthalmic licensing boards, professional associations, and consumer groups. 11 The Commission then sought comment on a proposed rule to eliminate certain advertising restraints on ophthalmic goods and services, and indicated that if evidence showed that consumers were being prevented from price shopping—due to the unavailability of prescriptions—the Commission might require prescribers to give patients copies. 12 10 Eyeglass I Report, supra note 6, at 1. 11 Id. 12 Id. FTC staff subsequently released its Eyeglass I Report detailing practices that prescribers used to discourage consumers from taking prescriptions to be filled elsewhere, including (1) outright refusal to release prescriptions or refusal to conduct examinations unless the patient agreed to purchase eyeglasses; (2) charging an additional fee as a condition to releasing the prescription; and (3) conditioning the release of the prescription on the patient signing a release or waiver of liability. 13 Staff explained that significant evidence—including testimony from optometrists, patients, and consumer groups, as well as prescriber surveys and published statements from boards of optometry and opticians—established that such practices were a serious and pervasive problem. 14 The Report concluded that refusal to release prescriptions, or placing conditions on their release, constituted an unfair act or practice, and recommended that the Commission promulgate a rule “insuring consumers unconditional access to their ophthalmic prescriptions.” 15 13 Id. at 241. With respect to liability waivers and releases, the Eyeglass I Report concluded that there could be “little doubt” that their primary intent was to discourage or dissuade consumers from taking their eyeglass prescriptions elsewhere to be filled. Id. at 277. 14 Id. at 241-45, 252-54. 15 Id. at 259, 263-65. On June 2, 1978, the Commission issued the Advertising of Ophthalmic Goods and Services Rule (the “Eyeglass I Rule”), which, among other things, contained a provision titled “Separation of Examination and Dispensing” requiring prescribers to automatically release prescriptions to their patients—regardless of whether or not the patients requested them—to ensure consumers unconditional access to their prescriptions so they could comparison-shop for eyeglasses. 16 In the Rule's Statement of Basis and Purpose, the Commission explained that evidence conclusively established that consumers suffered substantial economic loss through the imposition of surcharges for obtaining their prescriptions, and through lost opportunity costs arising from an inability to comparison-shop for eyeglasses. 17 Furthermore, the Commission found that prescribers' use of waiver notices and disclaimers deceived consumers as to the capabilities of other optical dispensaries, and further restricted purchase options. 18 Such practices offended public policy in that they denied consumers the ability to effectively use available information, and inhibited competition in retail eyeglasses markets. 19 16 Eyeglass I Rule, 43 FR 23992, 23998, 24007-08. 17 Id. at 24003. 18 Id. 19 Id. The Commission added that while it considered only requiring prescription release upon consumer request, it opted instead for so-called “automatic release” due to consumers' lack of awareness that they could purchase eyeglasses elsewhere, and because absent automatic release, there might be “evidentiary squabbles” over whether consumers did or did not request their prescription. 20 In addition, the Commission noted there was no evidence to suggest automatic release would impose a significant burden on prescribers. 21 20 Id. at 23998. 21 Id. After issuance of the Eyeglass I Rule, the American Optometric Association (“AOA”), representing most of the country's optometrists, challenged it, and in 1980 the D.C. Circuit overturned Rule provisions pertaining to advertising restrictions. 22 The court, however, upheld the automatic prescription release requirement, finding there was ample evidence that withholding prescriptions harmed consumers by making comparison-shopping harder, removing incentives for ophthalmic goods sellers to advertise, and reducing opticians' ability to compete. 23 The court also noted there was considerable evidence that prescribers had used waivers and liability disclaimers “to discourage comparison shopping, to mislead consumers . . ., and to frighten consumers into purchasing ophthalmic goods and services” from the prescriber. 24 22 Am. Optometric Ass'n v. FTC, 626 F.2d 896, 910-11 (D.C. Cir. 1980). 23 Am. Optometric Ass'n, 626 F.2d at 915. 24 Id. at 916. 2. Eyeglass II Report and Rule Following the court's remand of the Eyeglass I Rule, FTC staff conducted further investigation, and in 1980 issued a staff report entitled “State Restrictions on Vision Care Providers: The Effects on Consumers (“1980 Staff Report”). 25 The 1980 Staff Report did not make recommendations regarding the automatic prescription release provision, but instead suggested the Commission seek comment on whether to change it to release upon request, or to sunset the release requirement altogether. 26 25 “State Restrictions on Vision Care Providers: The Effects on Consumers” (1980), https://www.ftc.gov/reports/state-restrictions-vision-care-providers-effects-consumers-eyeglasses-ii 26 Id. at 248-49. The 1980 Staff Report, however, did propose extending the automatic release requirement to cover eyeglass dispensers, so that opticians—as well as optometrists and other eyeglass dispensers—would be required to return prescriptions to patients after fabricating the eyeglasses. Id. at 133, 260-61. The aim of staff's proposal was to guarantee patients access to their prescriptions even after they had been filled, and to ensure that consumers retained a copy so they could obtain duplicate glasses later without having to return to their original prescriber or eyeglass dispenser. Id. at 134, 261-64. Staff later reversed course on this proposal, however, after determining that there was insufficient evidence that dispensers were refusing to return prescriptions to patients. The Commission chose not to adopt the proposal. See “ Ophthalmic Practice Rules: State Restrictions on Commercial Practice,” 250, 300-02 (1986), https://www.ftc.gov/reports/ophthalmic-practice-rules-state-restrictions-commercial-practice-eyeglasses-ii-report-staff [hereinafter Eyeglass II Report]; Final Trade Regulation Rule, Ophthalmic Practice Rules, 54 FR 10285, 10303 (Mar. 13, 1989) [hereinafter Eyeglass II Rule]. Following the 1980 Staff Report, the Commission sponsored a survey to determine to what extent prescribers were complying with the Rule. The survey, commonly known as the “Market Facts Study,” found that only about one-third of prescribers automatically provided patients with prescriptions. 27 Thus, the majority of prescribers were not in compliance. The survey also found that only 38 percent of consumers knew they were entitled to receive their prescription automatically. 28 The survey found, however, that when consumers requested their prescriptions, by and large prescribers no longer refused to release them, 29 and that a majority of consumers had become “generally knowledgeable” about the availability of eyeglass prescriptions, appearing to know they could request one. 30 27 Eyeglass II Report, supra note 26, at 256. 28 Id. at 258. Forty-six percent wrongly believed they were entitled to the prescription only upon request, and 18 percent wrongly believed that prescribers were permitted to charge extra if the patient asked for the prescription. Id. 29 Id. at 253-62. 30 Id. Five years later, the Commission again reviewed the Rule and sought comment on whether consumers were aware of their right to obtain their prescription, 31 and whether the automatic release provision ought to be terminated, changed to release upon request, or changed to require that prescribers simply “offer” patients their prescriptions rather than automatically provide them. 32 After public hearings, the hearing officer issued a report to the Commission (“Presiding Officer's Report”) 33 finding that, although most prescribers would release prescriptions upon request, many were still not releasing them automatically. Accordingly, the presiding officer recommended that the automatic release requirement not be modified or terminated. 34 31 Ophthalmic Practice Rules, Notice of Proposed Rulemaking, 50 FR 598, 602 (Jan. 4, 1985). 32 The Commission received significant comment and evidence on whether to maintain automatic prescription release, repeal it, or change it to release upon request, but very little comment or evidence regarding the option of offering patients prescriptions. Eyeglass II Rule, 54 FR 10285, 10303 & n.182. 33 Report of the Presiding Officer on Proposed Regulation Rule: Ophthalmic Practice Rules, Public Record No. 215-63 (May 1, 1986), https://www.ftc.gov/reports/report-presiding-officer-proposed-trade-regulation-rule-ophthalmic-practice-rules-eyeglass-rule-16?msclkid=c8131b8ac63911ecb89f5b16ef81c791. 34 Id. In contrast, FTC staff issued its own report (“Eyeglass II Report”), which proposed changing the release provision from automatic release to release upon request. 35 Staff based its proposal on what it perceived to be altered market conditions and increased consumer awareness, as well as the difficulty staff had encountered enforcing the automatic release provision. 36 According to staff, the automatic release requirement had not succeeded at “avoiding evidentiary squabbles,” 37 but rather had increased them, since whether a prescriber had released a prescription could not, in most cases, be ascertained by documentary evidence. 38 35 Eyeglass II Report, supra note 26, at 249. 36 Id. at 249, 274-276. 37 Eyeglass I Rule, 43 FR 23992, 23998. 38 Eyeglass II Report, supr a note 26, at 275-76. Despite staff's recommendation, the Commission, in its final rule—referred to as the “Eyeglass II Rule”—sided with the Presiding Officer and opted to retain the automatic release component. 39 As the basis for its decision, the Commission cited the comments and testimony about continued prescriber non-compliance, 40 as well as the Market Facts Study and findings of the Presiding Officer, which established that many prescribers were not automatically providing prescriptions as required. 41 The Commission also cited an additional survey submitted by the American Association of Retired Persons (“AARP”), which found significant non-compliance and lack of consumer awareness, particularly among older consumers. 42 39 Eyeglass II Rule, 54 FR 10285, 10286-87. 40 Id. at 10303. 41 Id. at 10313 & nn.180 & 181; see also Eyeglass II Report, supra note 26, at 255-58 (reporting the Market Facts Study results). 42 Eyeglass II Rule, 54 FR 10285, 10303 nn.180 & 181; see also Eyeglass II Report, supra note 26, at 263 (reporting that the AARP survey of older Americans found that 47 percent did not receive a copy of their prescription, and 32 percent of those did not know to ask for one). The Eyeglass II Rule was again challenged by the optometric industry and, in 1990, much of the Rule was vacated, but not the prescription release requirements, which remained in effect. 43 43 See Cal. State Bd. of Optometry v. FTC, 910 F.2d 976 (D.C. Cir. 1990). The decision focused on a determination that the FTC lacked statutory authority to declare state laws of optometry to be unfair acts or practices without more explicit authority from Congress. Following the court decision, the Commission, in 1992, reissued the Eyeglass Rule, but without the portions declared invalid, and with renumbered designations pertaining to prescription release. See Final Trade Regulation Rule, Ophthalmic Practice Rules, 57 FR 18822 (May 1, 1992). 3. The 1997 to 2004 Eyeglass Rule Review In 1997, as part of its systematic review of its rules and regulations, the Commission again requested comment on whether the Rule's prescription release requirement should be retained, modified, or eliminated. 44 The Commission received comments from numerous parties but withheld taking action while it considered whether contact lenses should be covered by the Rule. Ultimately, after Congress passed the Fairness to Contact Lens Consumers Act (“FCLCA”), 45 the Commission issued a separate Contact Lens Rule (“CLR”) with prescription release requirements similar, in most respects, to those required by the Eyeglass Rule. 46 When the Commission turned again to the Eyeglass Rule and its prescription release requirement, it held that evidence in the rulemaking record suggested that prescribers continued to refuse to release eyeglass prescriptions, even though such conduct had been unlawful for nearly 25 years. 47 The Commission opined that were it to eliminate the prescription release requirement, even more prescribers might refuse to release prescriptions and thereby benefit from inducing patients to purchase eyeglasses from them. 48 Due to this possibility, and because it found the release of prescriptions enhances consumer choice at minimal compliance cost to prescribers, the Commission opted to retain the prescription release requirement. 49 44 Ophthalmic Practice Rules, Request for Comments, 62 FR 15865, 15867 (Apr. 3, 1997). 45 15 U.S.C. 7601-7610 (Pub. L. 108-164). 46 Contact Lens Rule, 16 CFR part 315. 47 Ophthalmic Practice Rules, Final Rule, 69 FR 5451, 5453 (Feb. 4, 2004). 48 Id. 49 Id. Furthermore, after reviewing the record and finding that some consumers still were not aware of their right to obtain their prescription, the Commission decided not to modify the Rule to require release upon request. The Commission stated that absent automatic release, consumers unaware of their right would not know to request their prescription, or their prescriber might discourage them from doing so. 50 In light of these considerations, the Commission determined to retain the Rule in its existing form. 51 In so doing, the Commission also ensured that prescription release requirements for eyeglasses would align with those for contact lenses under the Contact Lens Rule. 52 50 Id. The Commission also made findings that: release of prescriptions enhances consumer choice; no evidence had been submitted that the Rule's restrictions on disclaimers and waivers were no longer needed; the automatic release provision imposed only a minimal burden on prescribers; and retaining automatic release would keep the Eyeglass Rule consistent with the automatic release provision of the Contact Lens Rule, promulgated in 2004 pursuant to the Fairness to Contact Lens Consumers Act of 2003. Id.; see also Contact Lens Rule, 16 CFR part 315; Fairness to Contact Lens Consumers Act, 15 U.S.C. 7601-7610. 51 Ophthalmic Practice Rules, 69 FR 5451, 5453. 52 Id. See also Contact Lens Rule, 69 FR 40482 (July 2, 2004) (codified at 16 CFR part 315). 4. The 2015 to 2020 Contact Lens Rule Review As part of its periodic review of rules and guides, the Commission, on September 3, 2015, initiated a review of the Contact Lens Rule, including its prescription release requirement. 53 While the Contact Lens Rule differs from the Eyeglass Rule in some respects, many of the issues and concerns regarding prescription release and portability are the same, and therefore some of the comments and data submitted during the CLR review are pertinent to the Commission's review of the Eyeglass Rule. 53 Contact Lens Rule, Request for Comment, 80 FR 53272 (Sept. 3, 2015) [hereinafter CLR RFC]. During its review of the CLR, the Commission considered more than 8,000 public comments as it put forth a notice of proposed rulemaking 54 and supplemental notice of proposed rulemaking 55 before issuing an amended final rule on August 17, 2020. 56 In its CLR final rule, the Commission determined that the evidentiary record, as well as the Commission's enforcement and oversight experience, supports the view that prescriber compliance with the automatic prescription release requirement is sub-optimal, and, as a result, that millions of consumers are still not receiving their contact lens prescriptions as required by law. 57 The Commission further found that many consumers remain unaware that they even have a right to receive their prescriptions. 58 To remedy this, the Commission implemented a Confirmation of Prescription Release provision, requiring that prescribers request that a patient confirm receipt of their contact lens prescription. 59 According to the Commission, the patient confirmation requirement should result in, among other things, an increase in the number of patients in possession of their contact lens prescription and improved flexibility and choice for consumers, ultimately fostering improved competition in the market, more efficient contact lens sales, and lower prices for consumers. 60 The Commission also noted that the requirement would increase the Commission's ability to enforce and assess the CLR. 61 54 Contact Lens Rule, Notice of Proposed Rulemaking, 81 FR 88526 (Dec. 7, 2016) [hereinafter CLR NPRM]. 55 Contact Lens Rule, Supplemental Notice of Proposed Rulemaking, 84 FR 24664 (May 28, 2019) [hereinafter CLR SNPRM]. 56 Contact Lens Rule, Final Rule, 85 FR 50668 (Aug. 17, 2020) [hereinafter CLR Final Rule]. 57 Id. at 50687. 58 Id. 59 16 CFR 315.3(c). 60 CLR Final Rule, 85 FR 50668, 50687. 61 Id. C. The Evolving Eyeglass Marketplace The retail vision care industry in the United States consists of several different kinds of participants, namely ophthalmologists, optometrists, opticians, and eyewear retailers. The services provided by these different participants often overlap, and the different participants often have business affiliations with each other. Ophthalmologists are medical doctors who specialize in treating diseases of the eye. They are the only eye care professionals who can treat all eye and vision system diseases, perform eye surgery, prescribe nearly all manner of drugs, and use any treatment available to licensed physicians. Ophthalmologists can prescribe and sell eyeglasses and contact lenses, and their offices may be attached to an associated optical dispensary. Ophthalmologists have typically completed four years of medical school, a year of general internship, and an additional three years of specialized hospital residency training in ophthalmology. It is estimated that there are approximately 19,000 active ophthalmologists in the United States. 62 Many ophthalmologists, especially those who further specialize, 63 do not sell eyewear, although some do. 62 American Academy of Ophthalmology (“AAO”), “Eye Health Statistics,” https://www.aao.org/newsroom/eye-health-statistics. 63 According to the AAO, “[s]ubspecialists have intensive training in a particular area of the eye. To become subspecialists, ophthalmologists add a fellowship to their years of medical training. A fellowship prepares an ophthalmologist to treat more specific or complex conditions in certain parts of the eye or in certain types of patients.” AAO, “Ophthalmology Subspecialists” (June 6, 2016), https://www.aao.org/eye-health/tips-prevention/ophthalmology-subspecialists. Optometrists are doctors of optometry. They have not completed medical school, but have instead completed four years of training in optometry school, following three or more years of college. They are trained and licensed to examine eyes, diagnose refractive problems, prescribe and dispense eyeglasses and contact lenses, and detect eye disease. 64 As with ophthalmologists, optometrists can prescribe and sell eyeglasses and contact lenses, and their offices are often attached to, or part of, an associated optical dispensary. A government estimate indicates that in 2020 there were approximately 43,000 active optometrists in the United States. 65 While professional services, such as eye health and refraction examinations, generate significant revenue for optometrists, most optometrists still derive a larger percentage of their income from product sales, including the sale of eyeglasses and contact lenses. 66 According to some estimates, product sales typically account for 55 to 65 percent of optometrist revenue. 67 64 In some states, optometrists can prescribe medicine and perform certain surgeries. AOA, “What's a doctor of optometry?” https://www.aoa.org/healthy-eyes/whats-a-doctor-of-optometry?sso=y. 65 Bureau of Labor Statistics, U.S. Dep't of Labor, Occupational Outlook Handbook, Optometrists, https://www.bls.gov/ooh/healthcare/optometrists.htm (visited Apr. 27, 2022). 66 ECP University, “Key Metrics: Assessing Optometric Practice Performance & Best Practices of Spectacle Lens Management Report,” 25 (March 22, 2018), https://ecpu.com/media//wysiwyg/docs/ECPU_MBA_KeyMetricsReport_2018.pdf (“Independent optometric practices derive 35% of revenue from professional fees and 65% from product sales, including 37% from [eyeglasses] and 17% from contact lens sales”); Rev. Optm. Bus., “Challenges and Opportunities in the Future of Independent Optometry,” 3 (April/May 2013), https://www.reviewob.com/wp-content/uploads/2016/11/paa_visionsource__0413.pdf (stating that device sales remain the dominant revenue producer in most practices, typically accounting for 55 to 65 percent of revenue). 67 Id. See also Margery Weinstein, “Key Practice Metrics: Numbers to Track & Grow to Help Speed Practice Recovery,” Rev. Optm. Bus., https://www.reviewob.com/key-practice-metrics-numbers-to-track-grow-to-speed-practice-recovery/ (citing Care Credit, Independent Optometry Key Performance Metrics: 2019 Trend Report at 5, 9, and noting that product sales in 2019 continued to account for the majority of gross revenue (54%), but that eyeglass sales dropped from 42% of gross revenue in 2018 to 37% in 2019). Opticians, also known as dispensing opticians or ophthalmic dispensers, act primarily as retail providers of eyeglasses and contact lenses. Opticians fabricate, fit, adjust, and repair eyeglasses, primarily on the basis of prescriptions issued by optometrists and ophthalmologists. Opticians typically are not authorized to examine eyes to determine prescriptions, but may conduct pupillary distance examinations in order to fit a pair of eyeglasses to an individual. Twenty-one states currently require opticians to obtain licenses, 68 usually through a state-approved course of study and completion of an exam. The remaining states have no formal requirements for practice, but many opticians in these states complete some form of apprenticeship or training. A 2020 government estimate indicates that there are approximately 70,000 active opticians in the United States. 69 68 OpticianEDU.org, “Optician Certification,” https://www.opticianedu.org/optician-certification/. 69 Bureau of Labor Statistics, U.S. Dep't of Labor, Occupational Outlook Handbook, Opticians, https://www.bls.gov/ooh/healthcare/opticians-dispensing.htm (visited Apr. 27, 2022). Eyewear retailers are companies and independent merchants that sell eyeglasses. They often are owned by, employ, or associate themselves with, ophthalmologists, optometrists, and opticians. Some are considered independent optical retailers (defined as a retailer with three or fewer locations that has either an ophthalmologist, optometrist, optician, or optical retailer on site 70 ), while others may be optical chain stores, such as LensCrafters and America's Best, mass merchandisers, such as Costco and Sam's Club, department stores, such as Macy's, or online entities, such as Warby Parker and Zenni Optical. 70 Vision Council, “VisionWatch—The Vision Council Market Analysis Report,” Dec. 2019 [hereinafter VisionWatch Report], at 17. The overall retail eyeglass market continues to experience growth in both the number of eyeglass wearers as well as the number of eyeglasses purchased. As of December 2019, approximately 165 million American adults were regularly wearing prescription eyeglasses, representing nearly two-thirds of the country's adult populace. 71 In addition, some 30 percent of eyeglass wearers used two or more pairs interchangeably on a regular basis. 72 71 VisionWatch Report, supra note 70, at 24; see generally Vision Council, “U.S. Optical Overview and Outlook,” Dec. 2015, at 4-5 (discussing the growth of eyeglass usage from 2006 to 2015). 72 VisionWatch Report, supra note 70, at 43. Overall, in 2019, consumers purchased approximately 79 million pairs of eyeglass frames, and 88 million pairs of lenses 73 for a total sales volume of roughly $10 billion in frames and $14.3 billion in lenses. 74 Of total sales, the largest portion—at least in terms of dollars spent—occurred at independent optical retailers, who accounted for approximately 50 percent of U.S. eyeglass frame and lens sales in 2019. 75 Conventional optical chain stores accounted for approximately 27.5 percent of eyeglass frame and lens sales (in dollars), and mass merchandisers accounted for approximately 10 percent of eyeglass frame and lens sales (in dollars). 76 73 In 2019, about 89 percent of prescription lenses were purchased as a complete pair of eyeglasses (frames and lenses), representing about 78.3 million pairs of prescription eyeglasses. VisionWatch Report, supra note 70, at 11, 12, 60. By comparison, in 1975, American consumers purchased approximately 53 million pairs of prescription eyeglasses. Eyeglass I Report, supra note 6, at 11-12. 74 Vision Council, “Consumer Barometer,” Dec. 2019, at 2, 18-19. 75 Id. at 18-19. 76 Id. Optical centers in department stores accounted for approximately two percent of frame and lens sales (in dollars). Id. Online sales of eyeglasses remain a small portion of the optical market. According to one industry publication, as of June 2019 just five percent of sales (in dollars) of eyeglass frames derived from online sales during the previous year. 77 Consumers purchased approximately seven and a half million pairs of frames online, representing about 9.4 percent of all pairs of frames sold, in the 12 months ending June 2019. 78 But although online sales are still relatively small, they continue to increase steadily. Total online sales (in dollars) for all vision care products rose 7.7 percent between mid-2018 and 2019, 79 while online sales (in dollars) of frames grew 8.1 percent and of prescription lenses grew 10.8 percent in 2019. 80 A primary driver for the increase in online sales may be lower pricing. According to an industry source, as of 2015 online sellers were typically 50 to 60 percent less expensive than brick and mortar eyeglass retailers. 81 More recently, the COVID-19 pandemic may have spurred a greater number of consumers to shop for eyeglasses online, or to delay eyewear purchases altogether, but the long-term impact of the pandemic on consumer purchasing decisions is unknown. A study commissioned by The Vision Council showed that, in March 2020, when the World Health Organization declared COVID-19 a pandemic, over 25% of consumers stated an intention to buy eyewear online to limit human interaction and physical contact, more than double the number who planned to shop online before COVID-19. 82 77 Vision Council, “U.S. Optical Market Optical Overview,” Sept. 2019, at 12. The industry report does not specify whether the frames were purchased with prescription lenses or by themselves. Other data from the Vision Council, however, indicate that distribution percentages for sales of refractive lenses are nearly identical to that of frames, suggesting that the overall percentage of complete eyeglasses (frames and lenses) purchased online is about 5 percent of total sales (in dollars). Vision Council, “Consumer Barometer,” Dec. 2019, at 18-19. By comparison, approximately 15 percent of sales (in dollars) of contact lenses now derive from online sales. Vision Council, “U.S. Optical Market Optical Overview,” Sept. 2019, at 3, 6. 78 Vision Council, “U.S. Optical Market Optical Overview,” Sept. 2019, at 7. 79 See id. at 6. 80 Vision Council, “Consumer Barometer,” Dec. 2019, at 18-19. 81 Vision Council, “U.S. Optical Overview and Outlook,” supra note 71, at 65 n.3. 82 Vision Council, “Researching Recovery: Exploring Evolving Consumer Behavior and Industry Response During COVID-19,” May 21, 2020, at 38 (reporting results of VisionWatch Insights study), available at https://thevisioncouncil.org/sites/default/files/assets/media/TVC-COVID-19-VisionWatch-Consumer-Industry-Research_Member-Insights-Webinar-5-21-2020_w-Notes.pdf. D. State Regulation of the Sale of Eyeglasses As detailed above, the purpose of the Eyeglass Rule is to facilitate consumer choice and foster competition by separating the functions of the eye examination and the dispensing of prescribed eyeglasses. The Rule accomplishes this separation by requiring that prescribers provide consumers with a copy of their eyeglass prescription at the conclusion of the eye examination, and by prohibiting certain restrictions on the release of the prescription. The Eyeglass Rule, however, regulates only the release of the eyeglass prescription, and does not regulate other aspects of the practice of ophthalmology, optometry, or opticianry. 83 83 For example, although the Eyeglass Rule contains a definition of “prescription,” the purpose of the definition is to effectuate the separation of the exam and the sale of eyeglasses. The Rule's definition is not intended to preempt state regulations. See 16 CFR 456.1(g). State laws and regulations govern most aspects of professional practice and eyewear sales. Typically, individual state licensing boards are responsible for the licensing and oversight of ophthalmologists, optometrists, and opticians and, often, the dispensing of prescribed eyeglasses. These state regulatory frameworks vary widely. Some states have comprehensive regulatory frameworks that govern every aspect of dispensing prescribed eyeglasses: such regulations set forth the required components of an eyeglass prescription, the length and expiration date of an eyeglass prescription, and the allowable modes to transmit eyeglass prescriptions, as well as recordkeeping requirements. 84 Other states regulate less comprehensively. For example, some states require opticians to dispense eyeglasses only upon the written prescription of a prescriber, 85 while other states allow more flexibility. 86 Further, some states that require a prescription for the sale of eyeglasses do not explicitly set forth specific components of an eyeglass prescription. 87 State regulatory frameworks also differ on expiration dates for eyeglass prescriptions: some states require that eyeglass prescriptions expire within a certain period; 88 some states mandate that prescriptions be valid for at least a certain amount of time; 89 other states leave that determination to the prescriber; 90 while still other states are silent on the issue. 91 84 See Alaska Stat. Ann. §§ 48.310, 48.920; La. Admin. Code tit. 46, § LI-505. 85 See Ky. Rev. Stat. Ann. § 320.300; N.Y. Comp. Codes R. & Regs. tit. 18, § 505.6. 86 Mass. Gen. Laws Ann. ch. 112, § 73C (permitting duplications, replacements, reproductions or repetitions at retail without a prescription); N.C. Gen. Stat. Ann. § 90-235 (same). 87 N.C. Gen. Stat. Ann. § 90-236.1; Del. Code Ann. tit. 24, § 2122. 88 DC Mun. Regs. tit. 17, § 6416.1 (expiration of 1 year after the issue date unless there is a medical reason that warrants a prescription for less than 1 year.); Fla. Stat. Ann. § 463.012 (eyeglass prescriptions shall be considered valid for a period of 5 years). 89 Cal. Bus. & Prof. Code § 2541.1 (“The expiration date of a spectacle lens prescription shall not be less than two to four years from the date of issuance unless medical reason for earlier reexamination”); Mich. Comp. Laws Ann. § 333.5557 (setting expiration date of no less than 1 year from the date of the examination unless medical reason for shorter time). 90 852 Ind. Admin. Code 1-5.1-1 (stating it is the optometrist's responsibility to determine the expiration of the prescription.); Kan. Admin. Regs. § 65-8-4 (requiring prescriber to include on the prescription the “expiration date, if appropriate”). 91 Ark. Code Ann. § 17-90-108 (A)(3) (providing expiration term for contact lens prescriptions, but not for eyeglass prescriptions); Wis. Admin. Code Opt § 5.02 (providing that a contact lens prescription must contain the date of expiration, but making no mention of the expiration of eyeglass prescriptions). II. Eyeglass Rule Review A. Evidentiary Standard The Commission promulgated the Eyeglass Rule under section 18 of the FTC Act, which grants the Commission the authority to adopt rules defining unfair or deceptive acts or practices in or affecting commerce. 92 When amending or repealing the Rule, the Commission must follow the same section 18 procedures governing the adoption of rules, 93 and in doing so, engages in a multi-step inquiry. To make a determination that a practice is unfair, the Commission evaluates the following questions: (1) Does the act or practice cause or is it likely to cause substantial injury to consumers? (2) Is the injury to consumers outweighed by countervailing benefits that flow from the act or practice at issue? and (3) Can consumers reasonably avoid the injury? 94 92 15 U.S.C. 57a(a)(1)(B). 93 15 U.S.C. 57a(d)(2)(B) which states a substantive amendment to, or repeal of, a rule promulgated under subsection (a)(1)(B) shall be prescribed, and subject to judicial review, in the same manner as a rule prescribed under that subsection. 94 15 U.S.C. 45(n); see also Eyeglass II Rule, 54 FR 10285, 10287; Letter from the FTC to Hon. Wendell Ford and Hon. John Danforth, Committee on Commerce, Science and Transportation, United States Senate, Commission Statement of Policy on the Scope of Consumer Unfairness Jurisdiction (December 17, 1980), Appended to International Harvester Co., 104 F.T.C. 949, 1070, 1073 (1984). If an act or practice is deemed unfair, the Commission may issue a notice of proposed rulemaking under section 18 only where it has “reason to believe” that the unfair act or practice at issue is “prevalent.” 95 The Commission can find prevalence where information available to it indicates a widespread pattern of unfair or deceptive acts or practices. 96 Once the Commission finds that an unfair act or practice is prevalent, it has wide latitude in fashioning a remedy and need only show a “reasonable relationship” between the unfair act or practice and the remedy. 97 95 15 U.S.C. 57a(b)(3). 96 15 U.S.C. 57a(b)(3)(B). 97 Am. Fin. Servs. Ass'n v. FTC, 767 F.2d 957, 988 (D.C. Cir. 1985) (quoting Jacob Siegel Co. v. FTC, 327 U.S. 608, 612-13 (1946)). In making this proposal, the Commission has relied on a record that includes public comments received in response to the Commission's 2015 advance notice of proposed rulemaking (“ANPR”) that initiated this rule review, 98 and incorporates the rulemaking record for the 2020 amendments to the CLR to the extent that record provides information pertinent to the prescription release provision of the Eyeglass Rule. 99 The Commission has also examined the state of the marketplace and the content of consumer complaints about prescriber practices. Further, the Commission remains cognizant of the lengthy history and record that supported the enactment of the Eyeglass Rule and the CLR. Based on the entire record for the Rule, the Commission has reason to believe that prescribers' failure to automatically provide consumers with prescriptions at the completion of an eye exam—held to be an unfair act or practice when the Eyeglass Rule was enacted—remains prevalent, and millions of Americans every year are not receiving their eyeglass prescriptions as required by law. The Commission also believes that a risk of significant harm to consumers continues to exist and that, without the Rule's requirements, consumers could not reasonably avoid the injury resulting from the unfair acts and practices prohibited by the Rule. Further, the Commission believes that documentation of prescription release is necessary to better effectuate compliance with, as well as enforcement of, the Rule. Consequently, the Commission proposes amending the Rule to implement a Confirmation of Prescription Release requirement similar to that now required by the CLR. 100 Pursuant to these amendments, prescribers would be required to do one of the following: 98 Ophthalmic Practice Rules (Eyeglass Rule), Advance Notice of Proposed Rulemaking; Request for Comment, 80 FR 53274 (Sept. 3, 2015) [hereinafter Eyeglass Rule ANPR]. 99 The 2020 Contact Lens Rulemaking record includes comments to the CLR RFC; the CLR NPRM; the Public Workshop Examining Contact Lens Marketplace and Analyzing Proposed Changes to the Contact Lens Rule; Public Workshop and Request for Public Comment, 82 FR 57889 (Dec. 8, 2017) [hereinafter CLR WS]; and the CLR SNPRM. Public comments received in response to these notices are available on Regulations.gov . https://www.regulations.gov/document/FTC-2015-0093-0001 (CLR RFC Comments); https://www.regulations.gov/document/FTC-2016-0098-0001 (CLR NPRM Comments); https://www.regulations.gov/document/FTC-2017-0099-0001 (CLR WS Comments); and https://www.regulations.gov/document/FTC-2019-0041-0001 (CLR SNPRM Comments). Regulations.gov has assigned each comment an identification number appearing after the name of the commenter. This notice cites comments using the last name of the individual submitter, or the name of the organization and the individual within the organization who submitted the comment, along with the comment identification number assigned by Regulations.gov . 100 16 CFR 315.3. (i) Request that the patient acknowledge receipt of the prescription by signing a separate statement confirming receipt of the prescription; (ii) Request that the patient sign a prescriber-retained copy of a prescription that contains a statement confirming receipt of the prescription; (iii) Request that the patient sign a prescriber-retained copy of the sales receipt for the examination that contains a statement confirming receipt of the prescription; or (iv) 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. The Commission's proposal provides sample language for confirmation options (i), (ii), and (iii), but also allows prescribers to craft their own wording of the signed confirmation for these options if they so desire. As with the CLR's Confirmation requirement, the proposed Confirmation of Prescription Release requirement for eyeglass prescriptions would apply only to prescribers with a direct or indirect financial interest in the sale of eyeglasses. The Commission believes that the proposed amendment will prevent consumer harm, and that the proposed amendment is necessary to remedy demonstrated failures of some providers to automatically release prescriptions at the completion of an eye examination, and to ensure a competitive marketplace for eyeglasses. The Commission notes that providers who comply with the automatic release provision of the Rule may face a competitive disadvantage because of the widespread non-compliance of other providers. This creates an unlevel playing field and undermines competition. The Commission is sensitive to any additional burden or cost that this rule change imposes on business. However, it believes that this proposal maximizes the benefits of comparison-shopping with a relatively small burden or cost on business. The potential benefit of increasing the number of patients in possession of their eyeglass prescriptions is substantial: namely, increased flexibility and choice for consumers; a reduced likelihood of errors associated with incorrect, invalid, and expired prescriptions, and consequently, improved patient safety; and an improved ability for the Commission to enforce and monitor prescriber compliance with the Rule's prescription release requirements. The proposal would also align the prescription release related provisions of the Rule with the CLR, thereby reducing confusion and complexity that might arise for consumers and prescribers from having different prescription release requirements for eyeglass and contact lens prescriptions. In addition, because the CLR already obligates ophthalmologists and optometrists to release contact lens prescriptions, to obtain a confirmation, and to maintain records, the marginal cost of the proposed amendment to the Eyeglass Rule would be extremely low. Prescribers likely have forms and systems in place already, which may need only minor adjustments to accommodate confirmations for eyeglasses prescriptions. The Commission also proposes permitting prescribers to comply with automatic prescription release via electronic delivery in certain circumstances. 101 The Commission does not propose, at this time, to implement other recommendations about which it requested comment in the ANPR, including requiring prescribers to provide duplicate copies of prescriptions to patients; to provide a copy of a prescription to, or verify a prescription with, third-party sellers; or to add pupillary distance to prescriptions. 101 See Section IV.B.2.a, infra. The Commission also clarifies that the presentation of proof of insurance coverage shall be deemed to be a payment for the purpose of determining when a prescription must be provided under 16 CFR 456.2(a), a clarifying, technical rule amendment. See Section IV.B.3, infra. The Commission further clarifies that the term “eye examination” used in the Rule refers to a refractive eye examination. See Section V.C, infra. B. Overview of Comments in Response to ANPR In September 2015, as part of its routine review of Commission rules and guides, the Commission published the ANPR seeking public comment on, among other things: the continuing need for the Rule; the Rule's economic impact and benefits; possible conflict between the Rule and state, local, or other federal laws or regulations; and the effect on the Rule of any technological, economic, or other industry changes. The Commission also sought comment on the following specific questions: should the definition of “prescription” be modified to include pupillary distance; should the Rule be extended to require that prescribers provide their patients with a duplicate copy of a prescription; and should the Rule be extended to require that a prescriber provide a copy to or verify a prescription with third parties authorized by the patient? 102 102 Eyeglass Rule ANPR, 80 FR 53274, 53276. This notice of proposed rulemaking summarizes the comments received in response to the ANPR and explains why the Commission continues to believe that the Eyeglass Rule is necessary. It also explains why the Commission is proposing certain amendments and why it declines to propose others. Additionally, it seeks additional comment on certain questions. Finally, the NPRM sets forth the Commission's regulatory analyses under the Regulatory Flexibility and Paperwork Reduction Acts, as well as the text of the proposed amendments. The Commission received 868 comments in response to the ANPR from a variety of individuals and entities, including ophthalmologists, optometrists, opticians, trade associations, consumers (and representatives of consumers), and eyeglass sellers. 103 Virtually all of the comments supported retaining the Rule. Some commenters, including trade associations that represent opticians and retailers that employ optometrists and opticians, stated that the Rule is needed because some prescribers still are not automatically releasing prescriptions and some consumers face resistance when they try to obtain their prescriptions. 104 The AOA, which represents approximately 33,000 doctors of optometry, questioned the continued need for the Rule based on its understanding that doctors of optometry widely comply with the Rule's requirements, but stated that the Rule—as currently drafted—is not necessarily harmful. 105 103 The comments are posted at https://www.regulations.gov/document/FTC-2015-0095-0001. This document cites comments from the Eyeglass Rule ANPR using the comment number assigned by Regulations.gov without the preceding identification “FTC-2015-0095.” The citations also include: for comments submitted by individuals, the last name of the commenter; and for comments submitted on behalf of organizations, the name of the organization and the last name of the individual submitting on behalf of the organization. For instance, the full comment number assigned by Regulations.gov to the comment submitted by an individual named Publi is FTC-2015-0095-0040. In this document, that comment is cited as “Public (Comment #0040)”. 104 See, e.g., Opticians Association of Virginia (Comment #0647 submitted by Nelms) (stating that patients are led into the dispensary before paying for their exam and requesting the Rule be amended to include language that the prescription be given to the patient without additional sales pressure or intimidation); Burchell (Comment #0866); NAOO (Comment #0748 submitted by Cutler); Professional Opticians of Florida (Comment #0803 submitted by Couch). Other commenters more generally stated their support for the Rule. See Publi (Comment #0040); Santini (Comment #0047); Costa (Comment #0068); Ellis (Comment #0189); Hildebrand (Comment #0220); Prevent Blindness (Comment #0385 submitted by Parry); DiBlasio (Comment #0441); Pulido (Comment #0019); Stuart (Comment #0841). 105 Comment #0849 submitted by Peele; see also Barnes (Comment #0043) (stating she complies with the Rule although it is unnecessary since any ethical doctor will release a non-expired prescription to a patient); Kanevsky (Comment #0364) (optometrist states she and the prescribers she knows comply with the Rule). Warby Parker, a large online eyeglasses retailer, 106 and a few consumers indicated their belief that ordering eyeglasses online is a good option as it provides consumers with an affordable and convenient choice. 107 Some indicated their support for Rule changes that would permit online sales to occur with greater ease. Specifically, some commenters supported requirements for prescribers to provide copies of prescriptions to authorized third-party sellers upon a seller's request and to provide duplicate copies of prescriptions to patients upon request. 108 Some commenters also suggested the Rule should require prescribers to post a “bill of rights” or conspicuous signage of consumers' rights to a copy of their prescription. 109 Some commenters also expressed support for adding a requirement that prescriptions include pupillary distance—a measurement needed for consumers to order eyeglasses online—and for the Rule to prohibit eyeglass prescriptions from including any expiration dates, or at least unnecessarily short-term expiration dates. 110 106 Warby Parker, which began as an online-only entity but now has over 100 brick and mortar locations in the U.S., began operations in 2010 and appears to be the largest online eyeglass seller. VisionMonday, “Top 50 U.S. Optical Retailers 2020,” available at https://www.visionmonday.com/vm-reports/article/key-optical-players-ranked-by-us-sales-in-2019/. 107 Thompson (Comment #0333); Berge (Comment #0352); Warby Parker (Comment #0817 submitted by Kumar); see also Senate Majority Leader Charles Schumer (Comment #0865). 108 See, e.g., DeMuth, Jr. (Comment #0055); Jozwik (Comment #0002); Schwartz (Comment #0514); Opticians Association of Virginia (Comment #0647 submitted by Nelms); Pulido (Comment #0019); Warby Parker (Comment #0817 submitted by Kumar); see also NAOO (Comment #0748 submitted by Cutler); Professional Opticians of Florida (Comment #0803 submitted by Couch); Opternative (now Visibly) (Comment #0853 submitted by Dallek). 109 Tedesco (Comment #0042) (signage); Warby Parker (Comment #0817 submitted by Kumar) (bill of rights and signage). 110 See, e.g., Hildenbrand (Comment #0049) (expiration); Fainzilberg (Comment #0051) (pupillary distance); Wintermute (Comment #0067) (pupillary distance); Cordivari (Comment #0069) (expiration); Dickens (Comment #0176) (pupillary distance); O'Dea (Comment #0188) (pupillary distance); Nystrom (Comment #0254) (expiration); Meszaros (Comment #0303) (expiration); Buntain (Comment #0529) (expiration); Morel (Comment #0712) (expiration); Warby Parker (Comment #0817 submitted by Kumar) (expiration and pupillary distance). On the other hand, many prescribers felt the Commission should limit, ban, or regulate the online sale of eyeglasses on grounds that such sales are less safe because eyeglasses sold online do not always adhere to prescription specifications and glass impact-resistance requirements. 111 Some prescribers commented that their offices are burdened by the problematic practices of internet-based eyewear companies, since the patient ultimately goes to their prescriber for a remedy if they have an issue with their online eyeglass purchase. 112 111 See, e.g., Pentecost (Comment #0626); Bolenbaker (Comment #0633); McWilliams (Comment #0635); Cervantes (Comment #0671); Harrison (Comment #0718); Nellis (Comment #0725); Ambler (Comment #0025). 112 AOA (Comment #0849 submitted by Peele); Pentecost (Comment #0626); McWilliams (Comment #0635); Nellis (Comment #0725); Diener (Comment #0017). The AOA also stated its concern that some online retailers may be using foreign manufacturers with questionable labor standards. Comment #0849. The AOA stated that the Rule should not require prescribers to provide additional copies of prescriptions to consumers because prescribers must be allowed to use their clinical judgment to determine whether it is appropriate to provide additional copies after the eye exam was performed. 113 The organization also questioned the FTC's authority to add a requirement to the Rule mandating that prescribers respond to authorized third-party requests. 114 The American Academy of Ophthalmology (“AAO”), the largest national member association of ophthalmologists, stated that it was unaware of any significant issues with consumers receiving duplicate copies of their prescriptions from ophthalmologists, noting that its members put significant time and resources into ensuring patients receive prescriptions in a timely manner and traditionally provide duplicates without charge. 115 113 Comment #0849 submitted by Peele. The AOA also stated that it is already common practice for prescribers to provide duplicate copies of prescriptions upon request. Id. 114 Id. 115 Comment #0864 submitted by Haber. Further, the AOA, the AAO, and individual prescribers commented that the Rule should not require that a prescription include pupillary distance, because, among other reasons, they believe this measurement is part of the dispensing of eyeglasses, and not part of a refractive examination. 116 Prescribers also generally did not support having an expiration date of more than one year for eyeglasses, or requested that the FTC defer to state law and the medical judgment of prescribers to determine if and when a prescription should expire. 117 116 See, e.g., AAO (Comment #0864 submitted by Haber); AOA (Comment #0849 submitted by Peele); Johnson (Comment #0654); Nichols (Comment #0461); Patterson (Comment #0469); Chung (Comment #0474); Wareham (Comment #0498); Yuhas (Comment #0505); Mangano (Comment #0525); Hopkins (Comment #0776); Alvarez (Comment #0838). 117 See, e.g., AAO (Comment #0864 submitted by Haber); AOA (Comment #0849 submitted by Peele). A number of optician groups commented that the Rule should require that eyeglass dispensers only sell eyeglasses after obtaining a copy of a prescription, or verifying a prescription with the prescriber, to ensure the safety of their patients. 118 They also largely did not want the Rule to require that prescriptions include pupillary distance because they prefer to take this measurement and not be required to follow a measurement taken by the prescriber. 119 In addition, although many opticians stated a preference for a one-year expiration date, they did not object to a two-year expiration period unless a medical reason exists for requiring a shorter period of time. 120 118 See, e.g., Opticians Association of America (Comment #0638 submitted by Allen); Opticians Association of Kentucky (Comment #0640 submitted by Castle); Opticians Association of Vermont (Comment #0641 submitted by Williams); Opticians Alliance of New York (Comment #0642 submitted by Cullen); Opticians Association of Ohio (Comment #0683 submitted by Glasper); Opticians Association of Iowa (Comment #0646 submitted by Dalton); South Carolina Association of Opticians (Comment #0822 submitted by Harbert). 119 Id. 120 Id. III. Requirements for Eyeglass Sellers Although the Eyeglass Rule imposes certain requirements and limitations on prescribers—namely that they automatically release eyeglass prescriptions and do not charge fees or demand liability waivers for doing so—the Rule does not otherwise regulate the sale of eyeglasses. In this respect, the Eyeglass Rule diverges from the Contact Lens Rule. For example, among other things, the CLR provides that a dispenser may only sell contact lenses in accordance with a valid prescription that is either presented to the seller or verified by the prescriber. 121 The CLR is based on the language Congress set forth in the FCLCA, 15 U.S.C. 7603, whereas the Eyeglass Rule is more narrowly tailored and does not regulate the terms of sale for eyeglasses. The Commission's September 3, 2015 ANPR did not specifically request comment on this issue. However, in response to the Commission's request for feedback on general issues, including its request for modifications to the Rule that may increase benefits to consumers, some commenters offered their views on this topic, with many opining that the FTC should more closely regulate eyeglass sales. 121 See 16 CFR 315.5(a). In particular, the Opticians Association of America, a national organization of opticians with over 10,000 members, commented that to ensure patient safety, the Commission should mandate that all sellers only sell eyeglasses after obtaining a copy of the prescription, or after verifying the prescription information with a prescriber. 122 122 Comment #0638 submitted by Allen; see also Opticians Association of Kentucky (Comment #0640 submitted by Castle); Opticians Association of Vermont (Comment #0641 submitted by Williams); Opticians Alliance of New York (Comment #0642 submitted by Cullen); Duff (Comment #0653); Opticians Association of Ohio (Comment #0683 submitted by Glasper); Parent (Comment #0693); Groenke (Comment #0697); Kline (Comment #0710); Schrup (Comment #0765); Kuhl (Comment #0766); Gorsuch (Comment #0773); Frein (Comment #0774); Hopkins (Comment #0776); Feldman (Comment #0780); Anderson (Comment #0781); Lyden (Comment #0792); Jackson (Comment #0707); Meinke (Comment #0795); Lorenczi (Comment #0796); Keas (Comment #0798); Burkhart (Comment #0805); Albee (Comment #0806); Rivera (Comment #0809); Warden (Comment #0820); Anderson (Comment #0714); South Carolina Association of Opticians (Comment #0822 submitted by Harbert); Sansbury (Comment #0825); Williamson (Comment #0827); Ardis (Comment #0830); Folline Vision Centers (Comment #0837); Rump (Comment #0843); Murtha (Comment #0844); Heaton (Comment #0845); Gage-Halman (Comment #0846); Malonjao (Comment #0856); Jozwik (Comment #0002) (commenting that verification minimizes mistakes since the information is straight from the prescriber). Some commenters also stated that eyeglasses sold online are inferior in quality, or may come with an incorrect prescription. 123 The Opticians Association of Alaska, Inc., for example, commented that much of the eyewear sold online “does not meet national tolerance standards,” and asserted that consumers often rely on brick and mortar dispensaries to remedy problems stemming from poorly manufactured eyeglass products purchased online. 124 123 See, e.g., Strahl (Comment #372); Senate Majority Leader Charles Schumer (Comment #0865); Pentecost (Comment #0626); Harrison (Comment #0718); Nellis (Comment #0725). 124 Comment #0852 submitted by Brand. The Opticians Association of America and others commented that consumers' eye health may be negatively affected by unrestricted sales practices, and called the lack of required verification for sellers a “loophole” in the Rule. 125 Other commenters proposed that, regardless of whether a prescription is presented or verified, the online sale of eyeglasses should be limited or even banned altogether. 126 125 Opticians Association of America (Comment #0638 submitted by Allen); Opticians Association of Kentucky (Comment #0640 submitted by Castle); Opticians Association of Vermont (Comment #0641 submitted by Williams); Opticians Alliance of New York (Comment #0642 submitted by Cullen); Opticians Association of Ohio (Comment #0683 submitted by Glasper); South Carolina Association of Opticians (Comment #0822 submitted by Harbert). 126 See, e.g., Opticians Association of Alaska, Inc. (Comment #0852 submitted by Brand); Kline (Comment #0710). However, commenters submitted very little empirical evidence of consumer harm that would support restrictions on sales practices. The only data referenced or submitted in support of additional Commission regulation of eyeglass sales was a 2010 study focusing solely on the online sale of eyeglasses. That study, conducted by Dr. Karl Citek 127 and others, found that many eyeglasses sold by online retailers did not pass ANSI (American National Standards Institute) standards for prescription accuracy or safety. 128 In the study, ten individuals (consisting of the researchers and their colleagues and associates) ordered two pairs of eyeglasses apiece from ten online sellers. 129 The published report does not identify the sellers used, stating only that they were online eyeglass sellers with the ten highest page rankings (most visited) at the time. 130 According to the report, the eyeglasses purchased, and subsequently received in the mail, were then tested by an individual—described in the study as a researcher 131 —for prescription accuracy, and tested by an independent laboratory for impact-resistance. 132 The study found that of the eyeglasses purchased online, 28.6 percent contained at least one lens that failed at least one parameter of optical analysis, 133 and 22.1 percent had at least one lens that failed impact testing at the lab. 134 127 Dr. Citek is an optometrist and university professor. See https://www.pacificu.edu/about/directory/people/karl-citek-ms-od-Ph.D.-faao. 128 Karl Citek et al., “Safety and compliance of prescription spectacles ordered by the public via the internet,” Optometry, 82 (2011) 549-55. 129 Id. at 550. 130 Id. 131 Id. The study does not identify the researcher except by the initials “DLT,” which correspond to one of the article's authors, Daniel L. Torgersen. At the time, Torgersen was Vice President of Management Information Systems and Special Projects for the Walman Optical Company, an ophthalmic products provider, and technical director of the Optical Laboratories Association. Id. at 549; see also, VisionMonday, OLA Announces 2009 Directors' Choice Recipient and Awards of Excellence Final Nominees (Oct. 2009), available at https://www.visionmonday.com/latest-news/article/ola-announces-2009-directors-choice-recipient-and-awards-of-excellence-final-nominees-16057/?msclkid=740f9983c64b11ec8e35481006e0819a a. 132 Citek, supra note 128, at 550. The independent laboratory is not identified. 133 The parameters analyzed included sphere power, cylinder power, cylinder axis, and horizontal prism imbalance. Id. at 552. 134 Id. at 554. The Commission has reviewed the Citek study and has significant reservations about the study's conclusion that eyeglasses purchased online might not be “of equal performance, value, or safety” as those dispensed in person. 135 Significant weaknesses in the study's design and reporting limit its usefulness. For example, the study does not name the individual online retailers from whom lenses were purchased, nor provide results for each retailer in the study. Hence, even for the ten retailers in question, it is not possible to determine whether the 28.6 percent and 22.1 percent average failure rates reported are typical failure rates or are skewed due to significantly higher failures among a small number of relatively poorly performing actors. In addition, the study does not report how click-rates correspond to sales in the online market. Hence, it is unclear whether those online retailers were also the ten leading online retailers in terms of sales (either in dollars or pairs of eyeglasses), whether they accounted for any particular percentage of online eyeglass sales overall, or whether they were, by some measure, representative of online sellers generally. 135 Id. at 555. It is also unclear whether the Citek study's reported failure rate for online sellers is any different from that for eyeglasses purchased from traditional optical dispensaries. The study did not include eyeglasses purchased directly from prescribers or brick and mortar dispensaries. 136 The study does note, however, that, according to a previous study published in 1978, approximately 25 percent of eyewear manufactured for traditional dispensaries fail at least one parameter of optical analysis, a rate comparable to the online failure rate cited in the Citek study. 137 136 While none of the commenters submitted or referenced any additional studies evaluating eyeglass sales practices, the Commission is aware of a 2016 study from the United Kingdom analyzing the acceptability, quality, and accuracy of glasses purchased online and from optometry practices. Alison J. Alderson et al., “A Comparison of Spectacles Purchased Online and in UK Optometry Practice,” Optometry and Vision Science, 93 (2016) 1196-1202. The study involved 33 eyeglass wearers who purchased 154 pairs of eyeglasses online and 155 pairs in person from optometry practices in the United Kingdom. Eyeglasses were evaluated based on participant-reported preference, acceptability, and safety; an assessment of lens, frame and fit quality; and the accuracy of prescriptions to an international standard. Compared to the practice eyeglasses, participants rated more of the online eyeglasses unacceptable or unsafe due to poor fit, poor cosmetic appearance, or inaccurate optical centration distance. While participants preferred eyeglasses purchased from optometry practices to those purchased online, lens quality and prescription accuracy were similar between the two groups. Frame quality differed based on price, and the authors noted that the online frames were significantly less expensive and thus lower quality. The study authors noted areas for potential improvement in sales practices both for online sellers and optometry practices. This study is informative of the types of problems eyeglass wearers can encounter in an online or in person purchase and the preferences that may motivate consumers when choosing where to purchases eyeglasses, but the Commission does not believe it provides an adequate basis for imposing further regulatory requirements on eyeglass sellers. The study took place in the United Kingdom, rather than the United States, and online retailers were limited to those with a base in the United Kingdom, so the results are not necessarily applicable to the US market. The study had design limitations similar to the Citek study, such as not identifying the online retailers (or, in this case, the optometry practices), or providing the results for each retailer. Study authors selected online retailers based on search engine results, rather than sales volume, while study participants selected their own optometry practices within a limited set of restrictions. In addition, 97% of study participants had previously purchased their eyeglasses from optometry practices (and may have chosen to purchase from those same practices as part of the study), which might have led to confirmation bias in the self-reported assessments. Moreover, the study findings did not support a meaningful difference in the quality or accuracy of glasses purchased online as compared to those purchased in person. 137 See Citek, supra note 128, at 554 (citing G.A. Chase & B.E. Lynch, “An Examination of Ophthalmic Prescription Spectacle Quality Relative to the American National Standard Z80.1-1972,” Optical Index 1978; 53: 17-52). According to Citek, a subsequent unpublished study found that most of these failures are caught during secondary inspections before the eyeglasses leave the lab for the dispensary. Id. at 554. Because the testing in each of the three studies discussed herein was performed by different researchers in different settings in different decades, it is impossible to know if they were performing the same exact tests in the same exact manner, so comparisons between the Citek study and the other two studies are likely of questionable value. In addition, the Citek study is a decade old, and was conducted when the online sale of eyeglasses was in its relative infancy. The eyeglass market has changed considerably since 2010, and it is probable that online sales have changed in various ways: new sellers have entered the market, seller market shares have probably shifted (as well as relative page visits and click-through rates), and online vendors from 2010 who are still operating may have modified their business practices. Because of these and other concerns about the study, the Commission cannot accord it significant weight. Even if the Citek study were more compelling, however, it is unlikely it would provide, by itself, sufficient justification for adding new regulatory requirements to the Rule. The evidentiary record as a whole does not contain sufficient empirical evidence establishing that current eyeglass sales practices, whether by online vendors or competing brick and mortar establishments, are harmful to consumers and, therefore, should be banned or otherwise restricted. If the Commission had evidence of significant harm associated with one distribution channel in particular, it would need to assess whether new regulatory restrictions would ameliorate those harms in a way that would provide a net benefit to consumers. Furthermore, the Commission notes that certain states expressly permit sellers to duplicate eyeglasses, or do not require written prescriptions to make eyeglasses, 138 and a Commission regulation requiring presentation of a prescription or verification of a prescription would have to preempt these state laws. The Commission declines to take such action without more compelling empirical evidence of consumer harm or benefits. 138 See, e.g., Mass. Gen. Laws ch. 112, § 73C (duplication, replacements, reproductions, or repetitions may be done at retail without prescription); S.C. Code Ann. § 40-38-280 (duplications, replacements, reproductions, or repetitions may be provided without prescription). IV. Section 456.2—Separation of Examination and Dispensing A. Automatic Prescription Release Section 456.2(a) of the Eyeglass Rule provides that it is an unfair act or practice for a prescriber to fail to provide to the patient one copy of the patient's prescription immediately after the eye examination is completed. This provision provides, however, that a prescriber may refuse to give the patient a copy of the patient's prescription until the patient has paid for the eye examination, but only if that prescriber would have required immediate payment from that patient had the eye examination revealed that no ophthalmic goods were required. 139 Sections 456.2(b) and 456.2(c) prohibit prescribers from imposing conditions for patients to receive eye examinations and prescriptions. Section 456.2(b) provides that it is an unfair act or practice for a prescriber to condition the availability of an eye examination on a requirement that the patient agree to purchase any ophthalmic goods from the prescriber. Section 456.2(c) provides that it is an unfair act or practice for a prescriber to charge any fee in addition to the examination fee as a condition for releasing the prescription to the patient. 139 16 CFR 456.2(a). These provisions, typically referred to as the automatic prescription release requirement (also sometimes referred to historically as the required”separation of examination and dispensing”), 140 were intended to ensure that consumers have “unconditional access” to their ophthalmic prescriptions so they are able to “price shop” for eyeglasses. 141 As noted in the Eyeglass I Report, without the ability to unconditionally obtain their prescriptions, consumers lack available information to choose the mixture of quality and price that best satisfies their needs. 142 140 16 CFR 456.2; see also Presiding Officer's Report, supra note 33, at 17-24, 206. 141 Eyeglass I Rule, 43 FR 23992, 23992. 142 Eyeglass I Report, supra note 6, at 265 (citing hearing testimony from the then-Commissioner of the New York City Department of Consumer Affairs). 5. Comments on Whether To Retain Automatic Prescription Release In response to a request for comments on the continuing need for the automatic prescription release provision, 143 many commenters—including opticians, optometrists, ophthalmologists, eyeglass sellers, and consumers—expressed strong support. Several stated that the provision benefits consumers by fostering comparison-shopping and competition. 144 As one consumer commented, “[o]btaining a prescription for my eyeglasses has been crucial, improving my ability to purchase glasses at fair prices.” 145 Another declared that the Rule “has provided consumers the benefit of choosing where they'd prefer to buy their eyeglasses, saving them money on that expense.” 146 143 Eyeglass Rule ANPR, 80 FR 53274, 53275. 144 See, e.g., Publi (Comment #0040); Ellis (Comment #0189); Prevent Blindness (Comment #0385 submitted by Parry); DiBlasio (Comment #0441); Kelley (Comment #0804); Opternative (now Visibly) (Comment #0853 submitted by Dallek). 145 Varazo (Comment #0250). 146 Pulido (Comment #0019); see also Shuval (Comment #0564) (“The [E]yeglass [R]ule is a beautiful and wonderful thing. Giving patients a copy of their prescription is essential.”). Other commenters stressed a continuing need for this provision in the Rule, with some contending that the need is as great or greater now as when the Rule was first implemented. According to one comment (submitted on behalf of three individuals), the advent of online optical dispensaries can put more pressure on prescriber profits, making it even more vital to mandate automatic release in order to ensure that prescribers do not try to recoup lost profits by coercing patients to buy eyewear in-house. 147 According to this comment, the automatic release provision compels prescribers to remain competitive, leading to lower prices and higher quality eyeglasses. 148 Another commenter, the Professional Opticians of Florida, stated that since the Rule was first implemented, there has been a “dramatic increase” in prescribers' offices with attached optical dispensaries, increasing the potential for such prescribers to steer patients into purchasing eyeglasses in-house. 149 147 Burchell (Comment #0866). The FTC recognizes that the increase in online optical dispensaries may theoretically lead to reduced prescriber profits, but notes that the evidentiary record does not currently contain empirical evidence demonstrating this effect. 148 Id. 149 Comment #0803 submitted by Couch. Opticians, in particular, expressed strong support for the automatic prescription release requirement, with the National Association of Optometrists and Opticians (“NAOO”), a trade association representing co-located optical dispensaries, characterizing the Rule as a “triumph of narrowly tailored government action that directly addresses [a] specific consumer problem with minimal cost and remarkable benefits.” 150 According to NAOO, any costs to prescribers from prescription release has been “trivial,” while benefits to consumers have been significant, allowing them to comparison-shop and choose the optical dispenser of their choice. 151 This, in turn, according to the commenter, has helped foster exponential growth in the ophthalmic goods market. 152 NAOO added that it was critical to maintain the automatic release requirement due to the continuing “imbalance of power between patient and prescriber,” and powerful financial incentives for prescribers—who sell the products that they prescribe—to keep sales in-house. 153 150 Comment #0748 submitted by Cutler; see also, e.g., Ahrens (Comment #0022) (other opticians expressing support for automatic prescription release); Opticians Association of Alaska, Inc. (Comment #0852 submitted by Brand); Hoffman (Comment #0026). 151 Comment #0748 submitted by Cutler. The NAOO noted that based on member experience and observation, thousands of optometrists affiliated in co-location with their members comply with the Rule with “little or no added costs or other burden on the eye care practice.” Id. 152 Id. 153 Id. NAOO noted that optometry and ophthalmology are among the very few health care professions in which prescribers also sell, and often derive a significant portion of their income from, the products they prescribe. Id.; see also note 66, supra (product sales typically account for 55 to 65 percent of optometrist revenue). In commenting on the CLR, however, the AOA pointed out that health care professionals in other areas—such as ambulatory surgery centers, orthopedic centers, and dental service providers, among others, also sell what they prescribe or recommend for treatment. AOA (CLR SNPRM Comment FTC-2019-0041-0096). The Commission acknowledged this fact. CLR Final Rule, 85 FR 50668, 50679-80 (stating that the Commission did not base its CLR amendments solely on a belief that contact lens prescribers' role and market is necessarily unique, but rather considered the structure of the market as a contributing factor in an overall evaluation of the need for improved compliance and enforcement). On the other hand, the AOA commented that, “[i]t is our understanding that doctors of optometry widely comply with the Rule,” and did not believe that compliance with the prescription release provision remains an issue. 154 The AOA also stated that patients are well informed of their ability to obtain their eyeglass prescriptions and have a greater expectation to receive their health information from their doctors as a result of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”). 155 Accordingly, the AOA posited that “[g]iven that the requirements outlined in the Rule are now standard practice, it is questionable as to whether the Rule serves a continued benefit to patients.” 156 Nonetheless, the AOA did not expressly suggest modifying or terminating the prescription release provision, stating that the Rule, as currently drafted, is not necessarily harmful. 157 In addition, a few individual optometrists concurred that patients should be given their prescriptions after a refraction examination. 158 154 Comment #0849 Submitted by Peele. 155 Public Law 104-191 (Aug. 21, 1996); Comment #0849 submitted by Peele. 156 Comment #0849 submitted by Peele. 157 Id. 158 See, e.g., Kim (Comment #0667); Heuer (Comment #0670). None of the commenters expressly proposed eliminating the prescription release requirement. Some prescribers, however, commented that requiring automatic release is unnecessarily burdensome and wasteful, since not all patients want paper copies of their prescription. 159 As one prescriber explained, “A lot of patients don't want the copy and we end up throwing the paper away. I sometimes worry that if a patient chose not to take it, we would later be accused of not offering it to them.” 160 Some commenters suggested that instead of automatically providing a copy, the Rule should require that prescriptions be made accessible electronically, or only upon request. 161 159 Barnes (Comment #0043); Lunsford (Comment #0346). 160 Barnes (Comment #0043). 161 Lunsford (Comment #0346); B.C. (Comment #0749). 6. Compliance With the Automatic Prescription Release Requirement Commenters disagreed over whether most prescribers comply with the automatic prescription release requirement. As stated above, the AOA expressed its belief that doctors of optometry typically comply with the Rule. 162 In addition, several individual prescribers asserted that they always give patients a paper copy of their prescription. 163 Other individual prescribers commented that all the prescribers they know do the same. 164 It should be noted, however, that prescribers may be aware in a general way of their obligation to release prescriptions and yet be ignorant of the precise requirements of the prescription release provision. For example, in some instances, prescribers may violate the Rule by waiting for a patient to ask for the prescription, or asking a patient, “Do you want a copy of your prescription?” In both circumstances, the prescriber has violated the Rule since the prescription is not automatically provided. Indeed, a number of prescribers admitted to doing exactly that when commenting on the CLR, with many misstating the prescription release requirements and asserting that they always “offer” prescriptions to their patients or provide them “when requested,” rather than automatically providing prescriptions “whether or not requested by the patient,” as required under both the Contact Lens Rule and Eyeglass Rule. 165 Many prescribers may thus believe they are complying with the Rule even though they are not, and might also be incorrect in assessing, and reporting on, their own compliance and that of their colleagues. 162 Comment #0849 submitted by Peele. 163 Johnson (Comment #0654); Michel (Comment #0472); Cook (Comment #0541); Kaulfuss (Comment #0570); McWilliams (Comment #0635); Brosman (Comment #0637). Numerous prescribers who commented on the Contact Lens Rule proposals also wrote that they consistently release prescriptions to patients after each eye examination—including examinations for eyeglass prescriptions—and attested that their colleagues do the same. E.g., Carlson (CLR WS Comment FTC-2017-0099-0727) (“Each and every patient of mine gets their glasses and contact lens prescription at the end of their exam. It is not only the law but ethical.”); Chakuroff (CLR WS FTC-2017-0099-0763) (“Every patient I see is provided a copy of their glasses and contact lens prescriptions.”). 164 Kanevsky (Comment #0364); Smith (Comment #0365); Hartenstein (CLR WS FTC-2017-0099-0766) (“The overwhelming majority of eye doctors already provide patients with copies of prescriptions for both glasses and contact lenses per your previous mandates.”); see also CLR SNPRM, 84 FR 24664, 24673. 165 See CLR SNPRM, 84 FR 24664, 24673-74. Staff is aware of similar prescriber comments in the context of eyeglass prescriptions. The Eyeglass Rule specifically mandates that patients be handed a copy of their prescriptions automatically without their asking for them. And while seemingly minor, the act of waiting for a patient to ask, or offering a prescription rather than automatically providing it, can put patients in an awkward position, since they may feel they are showing disloyalty to their prescriber if they want to shop for eyeglasses elsewhere. See Eyeglass II Report, supra note 26, at 271 (noting that according to commenters, consumers are not always comfortable requesting their prescription, and may be unwilling to risk offending their doctors). Such an act may therefore undermine the Rule's intent to boost comparison-shopping and foster a vibrant marketplace. A number of commenters, meanwhile, asserted that, even though the Rule has required, for more than four decades, that prescribers automatically release eyeglass prescriptions to their patients, prescribers still routinely fail to comply, either by failing to provide a prescription unless requested, requiring a waiver in exchange for a prescription, or failing to provide a prescription at all. According to eyeglass seller and manufacturer Warby Parker, “[i]t is well known in the industry that many [prescribers] refuse to give patients prescriptions unless they specifically request it, and some [prescribers] place intimidating and unnecessary warnings or waivers of responsibility on the prescriptions they do release.” 166 166 Comment #0817 submitted by Kumar. One commenter, an optician, opined that the practice of prescribers failing to automatically release prescriptions is “flagrant,” 167 while another commented that “[i]t has been my observance that the Eyeglass Rule is not being complied with at all.” 168 These two commenters asserted that prescribers often do not provide patients with prescriptions until after patients are led into the prescriber's in-house optical dispensary, 169 a practice that would violate the Rule because the examination has concluded, and the patient should have already been provided with the prescription. And the NAOO commented that while it did not possess empirical evidence, “experiential and anecdotal evidence and observation of industry leaders indicates that while many consumers are getting a copy of their eyeglass prescription upon completion of the eye exam, some are not, and some are faced with resistance when they attempt to obtain their prescriptions.” 170 167 Santini (Comment #0047) (“In my area, it is common for eye care providers who exam [sic] AND Sell glasses to not be forthcoming with providing the spectacle Rx, particularly when consumers demand it”). 168 Tedesco (Comment #0042). 169 Id.; Santini (Comment #0047); see also Opticians Association of Virginia (Comment #0647 submitted by Nelms). 170 Comment #0748 submitted by Cutler. The Commission did not receive many comments from consumers specifically addressing the issue of prescription release in response to the ANPR. However, a number of consumers who commented during the CLR review stated that their prescribers failed to provide them with their prescriptions for contact lenses and for eyeglasses. 171 And separate from these rule review processes, the Commission continues to receive consumer complaints about noncompliance with the automatic release provisions of both the Eyeglass Rule and Contact Lens Rule. In December 2020, the Commission sent warning letters to 28 prescribers after consumers complained to the FTC that the prescribers had violated the Eyeglass Rule. 172 And in April 2016, the Commission sent warning letters to 45 contact lens prescribers after receiving complaints alleging the prescribers had violated the CLR by failing to release prescriptions. 173 171 See, e.g., Nichols (CLR WS Comment FTC-2017-0099-0209) (said she was charged for her eyeglass prescription); Tennison (CLR WS Comment FTC-2017-0099-0453) (does not receive written prescriptions for lenses or eye glasses after exams); Bogner (CLR NPRM Comment FTC-2016-0098-1398); Rasczyk (CLR NPRM Comment FTC 2016-0098-1415); Strobel (CLR NPRM Comment FTC-2016-0098-1446); Austin (CLR NPRM Comment FTC-2016-0098-1514); Martinez (CLR NPRM Comment FTC-2016-0098-2090). A few other CLR consumer commenters, however, stated that although they do not receive their prescriptions after a contact lens fitting, they typically do receive them after a refraction exam for eyeglasses. See, e.g., Hall (CLR WS Comment FTC-2017-0099-0227); Krainman (CLR NPRM Comment FTC-2016-0098-1373); Zeledon (CLR NPRM Comment FTC-2016-0098-1377). 172 Press Release, Fed. Tr. Comm'n, FTC Sends 28 Warning Letters Regarding Agency's Eyeglass Rule (December 8, 2020), https://www.ftc.gov/news-events/press-releases/2020/12/ftc-sends-28-warning-letters-regarding-agencys-eyeglass-rule. Similarly, in May 2016, the Commission sent warning letters to 38 prescribers after receiving consumer complaints alleging violations of the Eyeglass Rule. Press Release, Fed. Tr. Comm'n, FTC Issues Warning Letters Regarding Agency's Eyeglass Rule (May 13, 2016), https://www.ftc.gov/news-events/press-releases/2016/05/ftc-issues-warning-letters-regarding-agencys-eyeglasses-rule. 173 Press Release, Fed. Tr. Comm'n, FTC Issues Warning Letters Regarding the Agency's Contact Lens Rule (Apr. 7, 2016), https://www.ftc.gov/news-events/press-releases/2016/04/ftc-issues-warning-letters-regarding-agencys-contact-lens-rule. During the Commission's CLR review, the AOA and several optometrists pointed out that based on a percentage of the total number of eye patients in the United States, the number of complaints to the FTC about prescribers' failure to release prescriptions is quite small. See CLR Final Rule, 85 FR 50668, 50676; CLR SNPRM, 84 FR 24664, 24674. This is correct, but does not mean that the number of prescribers who fail to release prescriptions is correspondingly small. As discussed in some detail in the CLR SNPRM and CLR Final Rule, a lack of formal consumer complaints about failure to release prescriptions does not equate with prescriber compliance. Based on the Commission's experience, the vast majority of injured or impacted consumers do not typically register complaints with the government, and even fewer are likely to file a formal complaint about a prescriber's failure to release their prescription. See CLR Final Rule, 85 FR 50668, 50676; CLR SNPRM, 84 FR 24664, 24674-75. Two commenters also submitted consumer survey evidence about prescriber compliance. Warby Parker submitted results from an October 2015 survey, conducted on the company's behalf by the polling firm SurveyMonkey, which reported that, of consumers who had purchased eyeglasses within the last three years, 47 percent of those who saw optometrists and 31 percent of those who visited ophthalmologists were not automatically provided with a physical copy of their eyeglass prescription. 174 174 Comment #0817 submitted by Kumar. The SurveyMonkey survey comprised 1,329 respondents recruited from a sample that was U.S. Census-balanced and representative of the national distribution of major demographic factors, including age, gender, geography, and income. Respondents were not informed of the identity of the survey sponsor. Survey respondents who had purchased eyeglasses within the last three years (65% of the total respondents) answered questions about prescription information, purchase behavior, and prescriber experience. Within the set of respondents who had purchased within the last three years, 54% had purchased within the last 12 months. There were no significant differences in responses regarding automatic prescription release between those who had purchased within the last year and those who had purchased between one and three years prior to the survey. The significant difference in automatic release compliance between optometrists and ophthalmologists may be due to the fact that fewer ophthalmologists sell eyeglasses, and might thus have less incentive to withhold a consumer's prescription, but the survey did not directly explore this issue. Another commenter, contact lens seller 1-800 CONTACTS, cited a survey—conducted on its behalf by the firm Survey Sampling International (“SSI”) and submitted previously with a comment on the Commission's Contact Lens Rule review—which found that only 34 percent of eyeglass wearers automatically received their prescriptions on the day of their office visit, with another 19 percent receiving it during their visit, but only after asking for it. 175 According to the SSI survey, some consumers were able to obtain their prescription at a later point by returning to their prescriber's office, but 39 percent of consumers never received their prescription at all. 176 175 Comment #0834 submitted by Williams. According to 1-800 CONTACTS, the data derive from an October 2015 SSI online survey of 303 prescription eyeglass wearers. See “FCLCA Study, Focus on Prescription (Rx),” attached as Exhibit B to 1-800 CONTACTS (CLR RFC Comment FTC-2015-0093-0555 submitted by Williams). Respondents were not informed of the identity of the survey sponsor. The Commission has some concerns about the methodology utilized for this survey, particularly about the lack of an “I don't know” response option for some questions, but believes the information may still be suggestive, particularly when viewed in conjunction with information from other sources and the absence of contradictory data. 176 Id. The Commission has also reviewed five consumer surveys—submitted and considered during the CLR review—which found that between 21 and 34 percent of contact lens users did not receive their prescriptions after their exam and fitting. 177 These surveys asked only about receipt of contact lens prescriptions, not eyeglass prescriptions, and there are some differences in the examination and prescription processes. 178 But the mandatory prescription release requirements are similar, and there is little evidence in the record to indicate that prescribers provide eyeglass prescriptions in significantly greater numbers than they do contact lens prescriptions. 179 177 The results from the individual consumer surveys are as follows: (1) June 2019 survey by Dynata on behalf of 1-800 CONTACTS of 1,011 contact lens users found that 21% said they never received their prescriptions (1-800 CONTACTS (CLR SNPRM Comment FTC-2019-0041-0135)); (2) January 2017 survey by Caravan ORC International on behalf of Consumer Action of 2,018 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 (CLR NPRM Comment FTC-2016-0098-2954)); (3) December 2016 survey of 1,000 contact lens users by SSI on behalf of 1-800 CONTACTS found that 24% of consumer respondents said they did not receive their prescription (1-800 CONTACTS (CLR NPRM Comment FTC-2016-0098-2738)); (4) May 2015 SSI survey of 2,000 contact lens wearers found that 34% said they did not receive their prescription (1-800 CONTACTS (CLR RFC Comment FTC-2015-0093-0555 submitted by Williams, Ex. C)); and (5) November 2014 SSI survey of 2,000 contact lens wearers found that 34% said they did not receive their prescription (1-800 CONTACTS (CLR RFC Comment FTC-2015-0093-0555 submitted by Williams, Ex. C)). As noted in the CLR 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.” CLR SNPRM, 84 FR 24664, 24672. 178 A primary difference is that contact lens exams involve a lens “fitting,” in which consumers try on the lenses, and prescriptions are only to be provided after the fitting is complete. Fittings can entail sending consumers home with a set of lenses to try out for a few days, and thus sometimes the prescriber will not provide the prescription until after this process. This sometimes leads consumers to think they should have been provided their prescriptions when, in fact, the fitting was not yet complete. There is no such fitting for eyeglass prescriptions. In theory, this should mean that fewer eyeglass patients are confused as to whether they did or did not receive their prescriptions when they were supposed to. The fact that the percentage of eyeglass users surveyed who said they did not receive their prescriptions is roughly the same as, or even higher than, that of contact lens wearers surveyed adds considerable credence to both types of surveys, and provides further support for the conclusion that a substantial number of consumers are not automatically receiving their prescriptions from prescribers as the Rule requires. 179 As noted, supra note 171, a small number of consumer commenters to the CLR stated that although their prescribers fail to give them their contact lens prescriptions, they typically do provide them with their eyeglass prescription after each eye exam. See, e.g., Hall (CLR WS Comment FTC-2017-0099-0227); Krainman (CLR NPRM Comment FTC-2016-0098-1373); Zeledon (CLR NPRM Comment FTC-2016-0098-1377). The Commission has not seen empirical data that supports this (and, in fact, it appears to be contradicted by the consumer survey data). It is important to acknowledge that no survey is perfect, and all surveys are subject to methodological limitations, as well as limits commonly associated with survey evidence. The Commission has also recognized, however, that multiple surveys conducted by different sources at different times with similar results can bolster the credibility of each individual survey. 180 Furthermore, the Commission notes, as it did in the CLR Final Rule, 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 findings for either contact lens users or eyeglass wearers, or establishing (other than anecdotally) that consumers consistently receive their prescriptions from prescribers. 181 180 See CLR Final Rule, 85 FR 50668, 50675; CLR SNPRM 84 FR 24664, 24673. 181 See CLR Final Rule, 85 FR 50668, 50675. Consumer behavior and third-party seller experience may also reveal the level of prescriber compliance with the automatic prescription release requirement. For example, comments submitted pursuant to the rulemaking process, and staff communications with industry, indicate that many consumers who attempt to purchase eyeglasses from third parties do not present their prescriptions. 182 These consumers must either request a copy of their prescriptions from their prescribers or request that the sellers do so. 183 This suggests that these consumers were not provided with a copy of their prescriptions as required by the Rule. 184 182 See Warby Parker (Comment #0817 submitted by Kumar). 183 According to Warby Parker (Comment #0817 submitted by Kumar), before it processes an order it verifies every prescription by viewing a copy of the prescription or speaking with the customer's prescriber. In discussions with Warby Parker, the company has indicated that in 12 percent of all prescription eyewear orders (including both online and in-store orders), consumers utilize what is known as a “call doctor” request, whereby the customer requests that Warby Parker call the prescriber on behalf of the customer to obtain prescription information. However, the company noted that as of March 15, 2017, 15 percent of all “call doctor” requests Warby Parker made on behalf of its customers have been unanswered ( i.e., the prescriber has not provided the requested prescription information to Warby Parker). As a result, Warby Parker believes it may be more efficient for a customer to request the prescription information from the provider. 184 It is reasonable to expect that if consumers possessed copies of their prescriptions, many would provide them to third-party sellers instead of asking the sellers to obtain their prescriptions from their prescribers. It is also possible, however, that some consumers could have received copies of their prescriptions but misplaced them, or simply thought it easier for the third-party seller to obtain copies of the prescription than to locate and provide the copies themselves in the format requested by the seller. In terms of the scope of this issue, Warby Parker commented that it is required to expend substantial resources “persuad[ing prescribers] to provide the information required to fill a consumer order,” and that it informs between 50 and 100 consumers per day that it is unable to complete their eyeglass orders. 185 In addition, more than 20 consumers commented in this rule review that, when they tried to purchase eyeglasses, they asked their eyeglass sellers to obtain or verify the prescription with the prescribers, often without success. 186 Although this type of data does not allow the Commission to conclusively determine the level of prescriber compliance with automatic prescription release, or the number or percentage of consumers who might not have received a copy of their eyeglass prescription, it likely supports the finding that many patients are not automatically receiving a copy of their eyeglass prescriptions. 185 Comment #0817 submitted by Kumar. Unlike with contact lenses, prescribers are not required by rule to verify eyeglass prescription requests from third-party sellers. 186 See, e.g., Debnam (Comment #0039); White (Comment #0053); Kidwell (Comment #0054); Averett (Comment #0057); Silva-Sadder (Comment #0065); Tresham (Comment #0075); Ramiah (Comment #0139); Capurso (Comment #0149); Kulp (#0150); Lass (Comment #0197); Moran (Comment #0202); Wilbur (Comment #0215); Vieira (Comment #0237); Lavieri (Comment #0242); Donovan (Comment #0330); Panaccio (Comment #0340); Kingsley (Comment #0356); Gartland (Comment #0370); Gold (Comment #0340); Stout (Comment #0527); Crollini (Comment #0607). These commenters stated that their online orders were delayed, made more difficult, or defeated altogether, when their prescribers would not provide their prescription information. Lastly, it must be acknowledged that the same structural issue—an “inherent conflict of interest” in that prescribers sell the items they prescribe—that led the Commission to enact the Eyeglass Rule and CLR, and for Congress to enact the FCLCA, 187 and that the Commission cited as an ongoing factor in its decision to amend and strengthen the CLR, 188 still exists with respect to the eyeglass market and the Rule. According to some industry sources, eyeglass sales amount to approximately 37 to 44 percent of an optometric practice's gross revenue, with gross profit on eyeglass sales in the area of 62 percent. 189 While many prescribers have noted that they follow medical ethical codes that require they prioritize their patients' health, 190 it cannot be denied that it is contrary to prescribers' financial self-interest for their patients to take prescriptions elsewhere to buy eyeglasses. 191 187 See H.R. Rep. No. 108-318, 108th Cong., 1st Sess. 4 (2003) at 4-5 (2003) (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”). 188 CLR Final Rule, 85 FR 50668, 50678-80 (“Moreover, the existing regulatory structure in the U.S., which bars a consumer from obtaining contact lenses without a prescription while permitting prescribers to sell what they prescribe, creates regulatory-based economic incentives for some prescribers to not release prescriptions, or to not release them unless requested by the consumer.”). 189 ECP University, “Key Metrics: Assessing Optometric Practice Performance & Best Practices of Spectacle Lens Management Report,” 25, 40-41; see also note 66, supra. 190 AOA (Comment #0849 submitted by Peele). See also Leeper (CLR NPRM Comment FTC-2016-0098-0798); MacDonald (CLR NPRM Comment FTC-2016-0098-1586); Aman (CLR NPRM Comment FTC-2016-0098-2523); Woo (CLR NPRM Comment FTC-2016-0098-2254); Talley (CLR RFC Comment FTC-2015-0093-0601). 191 This, of course, was the basis for the Eyeglass Rule in the first place. The Commission determined that there was a long documented history of prescribers taking action to prevent or discourage patients from buying eyeglasses from third parties. See Eyeglass I Rule, 43 FR 23992, 24003. Even apart from any intentional actions prescribers may engage in to flout the Rule, this financial self-interest may result in prescriber bias to steer patients to purchasing glasses in-house. As the Supreme Court has observed, “established ethical standards may blend with private anticompetitive motives in a way difficult even for market participants to discern. Dual allegiances are not always apparent to an actor.” N.C. State Bd. of Dental Exam'rs v. FTC, 574 U.S. 494, 505 (2015). While some prescribers may sincerely believe that, from a health perspective, it is in their patients' best interest to obtain their eyeglasses from their prescriber, the Rule mandates that this decision belongs to the patient. 7. Evidence Regarding Consumers' Awareness of Their Right To Receive Their Prescription As with the question of Rule compliance, there was little consensus among commenters as to whether consumers are fully aware of their right to their prescriptions. 192 In its comment, the AOA asserted that patients are now well-informed of their ability to obtain their eyeglass prescriptions. 193 Other commenters disagreed, with some eyeglass sellers asserting that many patients are still not aware of the Rule and their rights. 194 192 The Rule's imposition of an obligation on a prescriber to automatically release an eyeglass prescription creates a corresponding right for consumers to receive it. See Eyeglass I Report, supra note 6, at 269 (“By requiring the release of the prescription in every case the public will have a clear, absolute right to their prescriptions.”). 193 AOA (Comment #0849 submitted by Peele). 194 Opticians Association of Virginia (Comment #0647 submitted by Nelms); NAOO (Comment #0748 submitted by Cutler); see also Warby Parker (Comment #0817 submitted by Kumar) (stating that many consumers are unaware of their rights and the Commission should try to increase awareness). In previous reviews of the Eyeglass Rule, the Commission received conflicting empirical evidence regarding the extent of consumer awareness, with some studies suggesting a relatively high degree of awareness, 195 and others indicating that consumers, particularly older patients, were unaware of their right to automatically receive a copy of their prescription. 196 For this review, none of the commenters submitted survey evidence specifically focused on consumer awareness of their right to their eyeglass prescription. One commenter, 1-800 CONTACTS, however, cited a survey submitted to the Commission during the Contact Lens Rule review which indicates that lack of awareness of a right to an eyeglass prescription is still an issue. 197 According to the survey, 49 percent of prescription eyeglass wearers are not aware that they have a right to receive a copy of their prescription, and 51 percent are not aware that their eye exam provider cannot charge for a copy of their prescription. 198 195 See Eyeglass II Report, supra note 26, at 257-62 (citing Market Facts Study for the finding that a large majority of those surveyed knew they did not have to purchase eyeglasses from the examining doctor and could ask for an eyeglass prescription after an examination, although many mistakenly thought they had to ask for it, and some thought doctors were allowed to charge extra for providing it). 196 See Presiding Officer's Report, supra note 33, at 22. 197 See “FCLCA Study, Focus on Prescription (Rx),” attached as Exhibit B to 1-800 CONTACTS (CLR RFC Comment FTC-2015-0093-0555 submitted by Williams). 198 Id. The manner in which the consumer awareness questions were phrased in the survey submitted by 1-800 CONTACTS did raise some concerns about the weight that should be accorded to the results. In particular, the questions were leading and used a term—“hard copy”—that some consumers might not understand. On the other hand, the question's phrasing may have led to under-reporting by consumers who in fact did not know their right, but did not want to admit that, because they did not want to acknowledge that they were unaware of their rights under federal law (this is known as social-desirability bias). See Diamond, Reference Guide on Survey Research, in Reference Manual on Scientific Evidence, 2nd. ed., 248-264 (Federal Judicial Center 2000), available at https://wwws.law.northwestern.edu/faculty/fulltime/diamond/papers/referenceguidesurveyresearch.pdf; Fowler, How Unclear Terms Affect Survey Data, The Public Opinion Quarterly (Summer 1992), available at https://www.jstor.org/stable/2749171; see generally, Carl A. Latkin, et al., The relationship between social desirability bias and self-reports of health, substance use, and social network factors among urban substance users in Baltimore, Maryland, 73 Addictive Behaviors 133-136 (2017) (social desirability bias is the tendency of survey respondents to answer questions in a manner that will be viewed favorably by others, and can skew survey results by over-reporting attitudes and behaviors that may be considered desirable attributes, while underreporting less desirable attributes). Social-desirability bias in this instance likely underestimates the number of patients unaware of their right to their prescription. In other words, the way the question was phrased could lead to results that make it appear that more patients are aware of their rights than is, in fact, the case. See “FCLCA Study, Focus on Prescription (Rx),” attached as Exhibit B to 1-800 CONTACTS (CLR RFC Comment FTC-2015-0093-0555 submitted by Williams) (One question was phrased, “Are you aware that it is your right under federal law, as a patient to receive a hard copy of your contact lens/eye glasses prescription from your eye exam provider?” and the other asked, “Are you aware of the following. . .—Your eye exam provider cannot charge you for an actual hard copy of your prescription?”). Furthermore, multiple other consumer surveys examined during the Contact Lens Rule review indicate that a high percentage of consumers (46 to 60 percent, according to submitted data) do not realize they are entitled to receive their contact lens prescription, 199 and it is likely that many of these consumers are also unaware they are entitled to their eyeglass prescription. 199 CLR SNPRM, 84 FR 24664, 24675 (citing a Caravan ORC International survey submitted by Consumer Action (CLR NPRM Comment FTC-2016-0098-2954) and SSI survey submitted by 1-800 CONTACTS (CLR NPRM Comment FTC-2016-0098-2738)). 8. Analysis of Evidence Regarding Automatic Prescription Release Provision Having considered the evidence compiled thus far—including the comments, empirical surveys, ongoing pattern of consumer complaints and anecdotal reports, and relevant evidence submitted during the CLR review (and the Commission's determinations in that regard), along with the industry's documented history of failing to provide eyeglass prescriptions automatically even when obligated by state and federal law—in conjunction with the intent, purpose, and history of the Eyeglass Rule, the Commission believes that there is still a significant need for the automatic prescription release provision. The Commission also concludes that improving compliance with, and consumer awareness of, the provision is necessary to further the goals of the Rule. Finally, the Commission sees a benefit—to both consumers and prescribers—in aligning the prescription release requirements and practices for both eyeglass and contact lens prescriptions. At the time of the Rule's initial implementation, the Commission determined that failure to release prescriptions was pervasive and widespread, and that this constituted an unfair act or practice under section 5. 200 In subsequent Eyeglass Rule reviews, the Commission noted that despite the Rule, com [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%3A2022-27828. Public record. Not legal advice.