# Contact Lens Rule > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3A2019-09627 ## Record - **Collection:** Federal Register - **Document type:** Proposed Rule - **Published:** May 28, 2019 - **Citation:** 84 FR 24664 ## Text FEDERAL TRADE COMMISSION 16 CFR Part 315 RIN 3084-AB36 Contact Lens Rule AGENCY: Federal Trade Commission (“FTC” or “Commission”). ACTION: Supplemental notice of proposed rulemaking; request for public comment. SUMMARY: As part of its regulatory review of the Contact Lens Rule (“Rule”), the Commission is proposing modifications to its prior proposal to amend the Rule to require that prescribers obtain a signed acknowledgment after releasing a contact lens prescription and maintain each such acknowledgment for a period of not less than three years. The Commission is further proposing to amend the Rule to: Permit prescribers to comply with automatic prescription release via electronic delivery in certain circumstances; specify a time-period for prescribers to respond to requests for prescriptions; clarify and institute additional requirements for automated telephone verification messages; more precisely delineate what constitutes unlawful alteration of a prescription; and require that sellers accept patient prescription presentation. The Commission seeks comment on these proposals. The Commission is not adopting any final amendments to the Rule at this time and continues to consider comments and information submitted in response to its Request for Comment of September 2015, its Notice of Proposed Rulemaking of December 2016, and its Notice Announcing Public Workshop and Request for Comment of December 2017. DATES: Written comments must be received on or before July 29, 2019. 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 “Contact Lens Rule Review, 16 CFR part 315, Project No. R511995” on your comment, and file your comment online at https://www.regulations.gov by following the instructions on the web-based form. If you prefer to file your comment on paper, mail your comment to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW, Suite CC-5610 (Annex B), Washington, DC 20580, or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW, 5th Floor, Suite 5610 (Annex B), Washington, DC 20024. FOR FURTHER INFORMATION CONTACT: Alysa Bernstein, Attorney, (202) 326-2903, Paul Spelman, Attorney, (202) 326-2487, or Andrew Wone, Attorney, (202) 326-2934, Division of Advertising Practices, Bureau of Consumer Protection, Federal Trade Commission, 600 Pennsylvania Avenue NW, Washington, DC 20580. SUPPLEMENTARY INFORMATION: Table of Contents I. Background A. Overview of the Contact Lens Rule B. History of the Rule C. Initial Request for Comments in 2015 D. Notice of Proposed Rulemaking in 2016 II. Supplemental Notice of Proposed Rulemaking A. Proposal To Modify Prior Signed-Acknowledgement Proposal B. New Proposals To Modify the Rule III. Option for Electronic Delivery of Prescriptions as a Means for Automatic Prescription Release A. Use of Patient Portals by Prescribers and Patients B. Analysis and Proposal IV. Modification of Prior Signed-Acknowledgement Proposal A. NPRM Automatic Prescription Release Proposal and Comments B. Comments on the Proposed Amendment to § 315.3(a)(1) 1. General Comments 2. Comments Concerning the Need for the Proposed Signed Acknowledgment Due to Non-Compliance a. Empirical Evidence of Compliance b. Verifications as Evidence of Lack of Prescription Release c. The Dearth of Consumer Complaints to the FTC as Evidence of Prescriber Compliance 3. Comments Concerning Whether a Proposed Signed Acknowledgment Is Needed for Better Enforcement and Auditing of the Rule 4. Comments About the Burden of the Signed-Acknowledgment Proposal 5. Comments on the Text of the Proposed Acknowledgment Form 6. Alternative Proposals to the Signed-Acknowledgment Proposal C. Additional Discussion and Proposal 1. A Confirmation From the Consumer Is Necessary for Enforcement and Monitoring 2. The Burden Is Relatively Small and Outweighed by the Benefits 3. Analysis and Proposal V. Requiring Prescribers To Respond to Requests for an Additional Copy of a Prescription Within Forty Business Hours A. Obtaining an Additional Copy of a Prescription B. Analysis and Proposal VI. Additional Requirements for Sellers Using Automated Telephone Verification Messages A. Issues With Automated Telephone Verification Messages B. Analysis and Proposal VII. Seller Alteration of Contact Lens Prescriptions A. Background B. Comments C. Analysis and Proposals 1. Seller Requirement To Accept Prescription Presentation 2. Seller Requirement To Verify Only the Contact Lens Brand or Manufacturer That Consumers Indicate Is on Their Prescriptions VIII. Request for Comments A. General Questions on Proposed Amendments B. Electronic Delivery of Prescriptions C. Confirmation of Prescription Release D. Prescriber Responses to Requests for an Additional Copy of a Prescription E. Automated Telephone Verification Messages F. Illegal Prescription Alteration IX. Communications by Outside Parties to the Commissioners or Their Advisors X. Paperwork Reduction Act A. Estimated Additional Hours Burden B. Estimated Total Labor Cost Burden C. Capital and Other Non-Labor Costs XI. Regulatory Flexibility Act 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 1. Amendments Affecting Prescribers 2. Amendments Affecting Sellers E. Duplicative, Overlapping, or Conflicting Federal Rules F. Significant Alternatives to the Proposed Amendments 1. Alternatives for Amendments Affecting Prescribers 2. Alternatives for Amendments Affecting Sellers I. Background A. Overview of the Contact Lens Rule In 2003, Congress enacted the Fairness to Contact Lens Consumers Act, 1 and pursuant to the Act, the Commission promulgated the Contact Lens Rule on July 2, 2004. 2 The Rule went into effect on August 2, 2004. 1 15 U.S.C. 7601-7610 (Pub. L. 108-164). 2 Contact Lens Rule, 16 CFR part 315 (2015). The Contact Lens Rule promotes competition in retail sales of contact lenses by facilitating consumers' ability to comparison shop for contact lenses. When a prescriber completes a contact lens fitting, the Rule requires that the prescriber automatically provide the patient with a portable copy of the patient's prescription, whether or not the patient requests it. The Rule also requires that the prescriber verify or provide such prescriptions to authorized third parties. At the same time, the Rule requires that sellers only sell contact lenses in accordance with valid prescriptions written by licensed prescribers that were either (a) presented to the seller by the patient or a designated agent of the patient or (b) verified by direct communication with the prescriber. 3 3 16 CFR 315.5(a). The Rule further sets out the information that must be included in a seller's verification request, and directs that a prescription is only verified under the Rule if: (1) A prescriber confirms the prescription is accurate; (2) a prescriber informs the seller that the prescription is inaccurate and provides an accurate prescription in its stead; or (3) the prescriber fails to communicate with the seller within eight business hours after receiving a compliant verification request. 4 The Rule states that if the prescriber informs the seller within eight business hours of receiving the verification request that the prescription is inaccurate, expired, or invalid, the seller shall not fill the prescription. The Rule requires that the prescriber specify the basis for the inaccuracy or invalidity of the prescription, and if the prescription is inaccurate, the prescriber must correct it. 5 Sellers may not alter a prescription, but for private label contact lenses, may substitute identical contact lenses that the same company manufactures and sells under a different name. 6 4 16 CFR 315.5(b)-(c). 5 16 CFR 315.5(d). 6 16 CFR 315.5(e). The Contact Lens Rule sets a minimum expiration date of one year after the issue date of a prescription with an exception based on a patient's ocular health. 7 The Rule also incorporates the Act's preemption of state and local laws and regulations that establish a prescription expiration date of less than one year or that restrict prescription release or require active verification. 8 7 16 CFR 315.6. 8 16 CFR 315.11(a). The Rule states further that “[a]ny other state or local laws or regulations that are inconsistent with the Act or this part are preempted to the extent of the inconsistency.” 16 CFR 315.11(b). B. History of the Rule The FTC has more than three decades of regulatory and research experience regarding the optical goods industry; this history continues to inform the basis and purpose of the Contact Lens Rule and this rule review. In addition to the Rule, the Commission enforces the Ophthalmic Practice Rules (known as the “Eyeglass Rule”), initially promulgated in 1978. 9 Prior to the Eyeglass Rule, many prescribers either refused to release prescriptions to their patients or charged an additional fee to do so. 10 Prescribers also used waivers and liability disclaimers to discourage comparison shopping, mislead consumers, and frighten them into purchasing ophthalmic goods from the prescriber. 11 The Commission determined that these actions reduced consumers' ability to obtain the lowest prices and hindered competition in the optical marketplace. 12 To address these problems, the Eyeglass Rule required prescribers—generally, optometrists and ophthalmologists—to provide each of their patients, immediately after completion of an eye examination, a free copy of the patient's eyeglass prescription. 13 9 Final Trade Regulation Rule, Advertising of Ophthalmic Goods and Services, 43 FR 23992 (June 2, 1978) [hereinafter Eyeglass I]. The Rule was revised in 1992, with the revisions codified at 16 CFR part 456. Ophthalmic Practice Rules, 57 FR 18822 (May 1, 1992). 10 43 FR at 23998. The Commission found, for example, that in nearly every survey of practicing optometrists considered in the rulemaking record, more than 50% of optometrists imposed a restriction on the availability of eyeglass prescriptions to patients. See also FTC, “Staff Report on Advertising of Ophthalmic Goods and Services and Proposed Trade Regulation Rule” 240-48 (1977) [hereinafter 1977 Staff Report] (detailing myriad accounts of prescribers refusing to release eyeglass prescriptions to their patients), https://www.ftc.gov/system/files/documents/reports/staff-report-advertising-ophthalmic-goods-services-proposed-trade-regulation-rule-16-cfr-part-456/r611003_-_staff_report_on_advertising_of_ophthalmic_goods_and_services_and_proposed_trade_regulation.pdf. 11 Am. Optometric Ass'n v. FTC, 626 F.2d 896, 916 (D.C. Cir. 1980) (noting considerable “evidence of abuse” by prescribers); see also 1977 Staff Report, supra note 10, at 277 (concluding that there could be “little doubt” that the primary intent of waivers was to discourage or dissuade consumers from taking their prescriptions elsewhere to be filled). 12 FTC, “The Strength of Competition in the Sale of Rx Contact Lenses: An FTC Study” 45-46 (2005), https://www.ftc.gov/sites/default/files/documents/reports/strength-competition-sale-rx-contact-lenses-ftc-study/050214contactlensrpt.pdf [hereinafter 2005 Contact Lens Report]. 13 16 CFR 456.2 (separation of examination and dispensing). The FTC also has studied the effects of state-imposed restrictions in the optical goods industry. See FTC, “The Effects of Restrictions on Advertising and Commercial Practice in the Professions: The Case of Optometry” (1980), https://www.ftc.gov/sites/default/files/documents/reports/effects-restrictions-advertising-and-commercial-practice-professions-case-optometry/198009optometry.pdf. The Eyeglass Rule, however, did not encompass contact lens prescriptions. While a majority of states enacted their own statutes requiring some form of contact lens prescription release, 14 many prescribers continued to withhold prescriptions for contact lenses. 15 This, and other prescriber practices (such as requiring liability waivers, refusing to verify prescriptions when consumers tried to buy lenses from third-party sellers, and encouraging manufacturers not to distribute contact lenses to third-party sellers), made it challenging for consumers to obtain lenses from anyone other than their prescribers. 16 According to Congress, these obstacles were rooted in an “inherent conflict of interest” in that “[u]nlike medical doctors who are prohibited from selling the drugs they prescribe, eye doctors and optometrists . . . are able to fill the contact lens prescriptions they write.” 17 Third-party sellers are thus forced to compete for the sale of lenses with the individual who is writing the prescription. 18 To address this inherent conflict of interest and achieve freedom of choice and the benefits of competition for contact lens consumers, Congress passed the Fairness to Contact Lens Consumers Act in 2003, 19 and, in 2004, the Commission issued the Contact Lens Rule, 20 implementing the Act. 14 By 2003, more than two-thirds of states had laws requiring some form of contact lens prescription release. H.R. Rep. No. 108-318, at 8 (2003). 15 See id. at 4 (noting that “[t]he practice of optometrists withholding the prescription [for contact lenses] has limited the consumer's ability to shop for the best price and has impacted competition.”); “Fairness to Contact Lens Consumers Act: Hearing Before the Subcomm. on Commerce, Trade, and Consumer Protection of the H. Comm. on Energy and Commerce,” 108th Cong. 1 (2003) [hereinafter FCLCA Subcomm. Hearing] (statement of Ami Gadhia, Consumers Union) (noting that multiple surveys of consumers in Texas had found considerable numbers were unable to obtain their contact lens prescription from their prescribers). 16 H.R. Rep. No. 108-318 at 4; FCLCA Subcomm. Hearing, supra note 15 (statements of Howard Beales, Jonathan Coon, Ami Gadhia, Robert Hubbard, Maria Martinez, Rep. W. J. Tauzin (La.); Peggy Venable). See also In re Disposable Contact Lens Antitrust Litig., No. 94-MDL 1030-J-20A (M.D. Fla.) in which the Attorneys General of 31 states alleged that eye-care professionals engaged in an organized effort to prevent or hinder consumers from obtaining their contact lens prescriptions. The complaints alleged two conspiracies: (1) That the practitioners and their trade associations conspired to prevent the release of contact lens prescriptions to consumers, and (2) that manufacturers, practitioners, and trade associations, including the American Optometric Association, conspired to eliminate sales of contact lenses by pharmacies, mail order, and other alternative sellers. Id. According to the Attorneys General, the conspiracy severely restricted the supply of contact lenses available to alternative sellers, which hampered the growth of such sellers, decreased the supply of lenses to consumers, and increased the price of lenses. Id. The parties reached settlements, the last of which the court approved in November 2001. As part of the settlements, manufacturers agreed to sell contact lenses to alternative distribution channels. During consideration of the FCLCA, one Congressman noted about the case, “The suit was settled, but it shows the extent of distrust for how contact lenses are currently dispensed by eye doctors and optometrists.” FCLCA Subcomm. Hearing, supra note 15 (statements of Rep. W.J. Tauzin (La.)). 17 H.R. Rep. No. 108-318, at 5. See also Letter from Senators Richard Blumenthal and Orrin G. Hatch of the United States Senate Regarding the Contact Lens Rule Rulemaking Proceeding and the Proposed Rule Set Forth in the Notice of Proposed Rulemaking (Aug. 11, 2017) (recognizing the “inherent conflict of interest” and noting that the FCLCA was made necessary by “the unique nature of the contact lens marketplace”), https://www.ftc.gov/system/files/filings/initiatives/677/ public_comment_from_senators_blumenthal_and_hatch_re_contact_lens_rulemaking.pdf [hereinafter Blumenthal Letter]. 18 H.R. Rep. No. 108-318, at 5 ; FCLCA Subcomm. Hearing (statements of Rep. W.J. Tauzin (LA)) (noting there is a “classic conflict of interest that robs the consumers of the ability to shop competitively for the best price,” and stating that the FCLCA takes the “necessary steps to remedy this stranglehold on contact lens competition.”). 19 15 U.S.C. 7601-7610 (Pub. L. 108-164). 20 Contact Lens Rule, 69 FR 40482 (July 2, 2004) (codified at 16 CFR part 315). Pursuant to its congressional mandate, the FTC also issued a study of competition in the contact lens industry in 2005. See 2005 Contact Lens Report, supra note 12. As specified in the Act, the Rule imposes requirements on both sellers and prescribers of contact lenses. Because the use of contact lenses involves significant health issues 21 and Congress recognized that consumers may be harmed by contact lenses purchased with an expired, inaccurate, or otherwise invalid prescription, 22 the Act requires that contact lenses be sold only to patients with valid prescriptions, which they receive after contact lens fittings by a prescriber. The Act and the Rule only allow sales of contact lenses when a patient presents a seller with a copy of the prescription or the seller has verified the patient's prescription with the prescriber. 23 Sellers also are prohibited from altering a contact lens prescription. 24 21 See, e.g., FTC, “Possible Barriers to E-Commerce: Contact Lenses, A Report from the Staff of the Federal Trade Commission” 8-9 (2004), http://www.ftc.gov/os/2004/03/040329clreportfinal.pdf. 22 Contact Lens Rule, 69 FR 40482. 23 16 CFR 315.5(a). 24 16 CFR 315.5(e). The Act and the Rule further impose obligations on prescribers. First and foremost, prescribers are required to release a copy of the prescription to the patient promptly upon completion of the contact lens fitting, “[w]hether or not requested by the patient.” 25 Prescribers also are prohibited from requiring: (1) The purchase of contact lenses as a condition of either prescription release or verification, (2) a separate payment for prescription release or verification, and (3) that the patient sign a waiver as a condition of prescription release or verification. 26 25 15 U.S.C. 7601(a)(1); 16 CFR 315.3(a)(1). 26 15 U.S.C. 7601(b)(1)-(3); 16 CFR 315.3(b)(1)-(3). Additionally, prescribers are required to provide or verify a contact lens prescription when “directed by any person designated to act on behalf of the patient.” 27 Such verification occurs when the seller provides the prescriber with a consumer's prescription information and: (1) The prescriber confirms that the prescription is accurate, by phone, facsimile, or electronic mail; (2) the prescriber informs the seller that the prescription is inaccurate and provides the correct prescription; or (3) the prescriber does not communicate with the seller within eight business hours of the seller's request for verification (“passive verification”). 28 The eight-business-hour passive verification lessens the demands on prescribers in the event a seller forwards a query about an accurate and complete prescription from a properly identified patient. It also prevents prescribers from blocking verification—and impeding consumer access to contact lenses that may be lower-priced, or sold by sellers who offer other benefits or convenience—simply by refusing to respond to verification requests. 27 15 U.S.C. 7601(a)(2) (must, as directed by authorized party, “provide or verify” the prescription); 16 CFR 315.3(a)(2). 28 15 U.S.C. 7603(d)(1)-(3); 16 CFR 315.5. One outcome of passive verification, however, if a prescriber does not respond to a verification request containing inaccurate information or for an invalid prescription within eight business hours is that the prescription is deemed verified; thus, passive verification allows for the possibility that patients can be sold lenses for which they do not have a valid prescription. Congress, when considering the FCLCA, was aware that a passive-verification regime could, in some instances, allow sellers to sell and ship contact lenses based on an invalid or inaccurate prescription, and that this could potentially lead to health risks. 29 Congress opted for a passive-verification regime despite this concern in order “to ensure that consumers are not caught in the competitive tug-of-war between doctors and third party sellers for the sale of contact lenses.” 30 It was also envisioned that prescribers would remain diligent in ensuring that patients did not receive lenses for which they had not been prescribed, since it is in both prescribers' self-interest and the health and safety interests of their patients to prevent this from occurring. 31 In this manner, the passive-verification system was perceived, to a certain extent, to be self-enforcing, as prescribers would have both a financial interest and an ethical duty to police invalid, incorrect, or expired prescriptions. 32 29 See, e.g., FCLCA Subcomm. Hearing, supra note 15 (statements of Howard Beales, Federal Trade Commission); Id. (statements of J. Pat Cummings, American Optometric Association) (“And the problem with passive verification is that people will get contact lenses without a prescription.”). 30 H.R. Rep. No. 108-318, at 5. 31 Contact Lens Rule, 69 FR at 40498. 32 FCLCA Subcomm. Hearing, supra note 15 (statements of Howard Beales, Federal Trade Commission) (stating that passive verification is in many respects self-enforcing). See also FCLCA Subcomm. Hearing, supra note 15 (statements of Jonathan Coon, 1-800 CONTACTS) (explaining to the Committee that from their experience with an existing passive verification-system in California, doctors have a motivation to block invalid-prescription sales. “So they tell us if there is any problem with the prescription, if it's expired, it's invalid, whatever the problem is with the prescription. If they can tell us, you can believe they tell us absolutely every time.”). C. Initial Request for Comments in 2015 As part of its periodic review of its rules and guides, on September 3, 2015, the Commission solicited comments on the Contact Lens Rule, seeking input on: The economic impact of, and continuing need for, the Rule; the benefits of the Rule to consumers purchasing contact lenses; the burdens the Rule places on entities subject to its requirements; the impact the Rule has had on the flow of information to consumers; the degree of industry compliance with the Rule; the need for any modifications to increase its benefits or reduce its burdens or to account for changes in relevant technology; and any overlap or conflict with the Rule and other federal, state, or local laws or regulations. 33 The comment period closed on October 26, 2015. The Commission received approximately 660 34 comments from individuals and entities representing a wide range of viewpoints, including prescribing eye-care practitioners (ophthalmologists and optometrists), opticians and other eye-wear industry members, sellers of contact lenses (both online and brick-and-mortar), contact lens manufacturers, and consumers. 33 Contact Lens Rule, 80 FR 53272 (Sept. 3, 2015). 34 Comment figures are approximations because identical comments are sometimes submitted more than once. D. Notice of Proposed Rulemaking in 2016 After a review of comments, surveys, other submitted information, and its own enforcement experience, the Commission determined that the overall weight of the evidence demonstrated a need to improve compliance with the Rule's automatic prescription-release requirement, as well as a need to create a mechanism for monitoring and enforcing the Rule. 35 To achieve this, the Commission issued a Notice of Proposed Rulemaking (“NPRM”) on December 7, 2016 that proposed to add a signed-acknowledgment requirement. 36 The signed-acknowledgment requirement would be triggered once the prescriber presented the prescription to the patient, and the acknowledgment form could be in either paper or electronic format. As proposed, the acknowledgment form would be entitled “Patient Receipt of Contact Lens Prescription,” and state, “My eye care professional provided me with a copy of my contact lens prescription at the completion of my contact lens fitting. I understand that I am free to purchase contact lenses from the seller of my choice.” Prescribers would be required to maintain copies of the acknowledgment forms in paper or electronically for not less than three years. 35 Notice of Proposed Rulemaking, 81 FR 88526 (Dec. 7, 2016) [hereinafter NPRM]. 36 Id. The NPRM also proposed a technical amendment, to remove the words “private label” from § 315.5(e) to conform the language of the Rule to that of the FCLCA, but that amendment is not at issue in this Supplemental Notice of Proposed Rulemaking. The NPRM sought comment on this proposal, and also about the following issues: The provision of additional copies of prescriptions, the amount of time for a prescriber to respond to such a request, the use of patient portals to release prescriptions, and potential modifications to address concerns about automated telephone verification calls. The sixty-day comment period for the Commission's NPRM closed on January 30, 2017. In response to its NPRM, the Commission received over 4,000 additional comments, many from prescribers concerned about the impact of the proposed signed- acknowledgment requirement. After considering these and other comments, the Commission determined that certain issues deserved additional discussion and examination. To obtain additional input and more fully consider commenter concerns, the Commission solicited additional comments 37 and held a public workshop on the Contact Lens Rule and the Evolving Contact Lens Marketplace on March 7, 2018. The workshop included six panels, covering issues relating to the overall contact lens marketplace, health and safety, competition, purchasing and verification, the proposed signed acknowledgment and consumer choice, and the future of contact lens prescribing and selling. In response to the Commission's request and workshop, the Commission received approximately 3,400 additional comments from a wide range of commenters, including numerous consumers and prescribers, as well as industry associations, state attorneys general, contact lens manufacturers, and retailers. 37 Public Workshop Examining Contact Lens Marketplace and Analyzing Proposed Changes to the Contact Lens Rule, 82 FR 57889 (Dec. 8, 2017). II. Supplemental Notice of Proposed Rulemaking After reviewing the comments, the Commission now proposes to modify its prior proposal—put forth in the NPRM—that would have required prescribers to request a signed statement from their patients acknowledging receipt of the patient's prescription. The Commission also proposes new amendments to the Rule. This Supplemental Notice of Proposed Rulemaking (“SNPRM”) summarizes the relevant comments received and explains the Commission's proposal to modify its signed-acknowledgment proposal and amend other sections of the Rule. 38 38 This SNPRM will only discuss comments specifically related to the modifications and amendments proposed at this time. The Commission will address other issues raised by commenters when the Commission issues its Final Rule. A. Proposal To Modify Prior Signed-Acknowledgment Proposal The Commission proposes to modify its prior proposal for a signed-acknowledgment requirement by instituting a more flexible Confirmation of Prescription Release provision. Rather than requiring that prescribers request that each contact lens patient acknowledge receipt of the prescription by signing a form stating, “My eye care professional provided me with a copy of my contact lens prescription at the completion of my contact lens fitting. I understand I am free to purchase contact lenses from the seller of my choice,” 39 prescribers would be required to do one of the following: 39 NPRM, 81 FR at 88559. (a) Request that the patient acknowledge receipt of the contact lens prescription by signing a separate statement confirming receipt of the contact lens prescription; (b) Request that the patient sign a prescriber-retained copy of a contact lens prescription that contains a statement confirming receipt of the contact lens prescription; (c) Request that the patient sign a prescriber-retained copy of the sales receipt for the examination that contains a statement confirming receipt of the contact lens prescription; or (d) If a digital copy of the prescription was provided to the patient (via methods including an online portal, electronic mail, or text message), retain evidence that such prescription was sent, received, or made accessible, downloadable, and printable. The precise wording of such confirmations would be left to the prescriber's discretion, but for prescribers opting for (a), (b), or (c), a patient's written or electronic signature would always be required. The prescriber would have to maintain evidence of the Confirmation of Prescription Release for at least three years, and make such evidence available upon request by the Commission. Unlike the Commission's prior acknowledgment proposal, which applied to all prescribers, the Confirmation of Prescription Release would only be required of prescribers who have a financial interest in the sale of contact lenses. B. New Proposals To Modify the Rule In addition to the proposed Confirmation of Prescription Release, the Commission further proposes to modify the Rule for prescribers and sellers in several ways. First, by adding to the Rule a definition of the term “provide to the patient a copy,” the Commission proposes to allow the prescriber, with the patient's verifiable affirmative consent, to provide the patient with a digital copy of the patient's prescription in lieu of a paper copy. Second, although the Rule has always required that prescribers, upon request, provide any person designated to act on behalf of the patient with a copy of the patient's valid contact lens prescription, the Rule did not prescribe a time limit in which the copy of the prescription had to be provided; the Commission now proposes forty business hours as a reasonable time period in which the prescription must be provided. The prescriber would also be required to note the name of the requester and the date and time the prescription was provided. Third, the Commission also now proposes new requirements for sellers using automated telephone verification messages. The proposal would require a seller to (1) record the entire call and preserve the complete recording; (2) begin the call by identifying it as a prescription verification request made in accordance with the Contact Lens Rule; (3) deliver the verification message in a slow and deliberate manner and at a reasonably understandable volume; and (4) make the message repeatable at the prescriber's option. To aid implementation of this proposal, the Commission further proposes to add definitions for the terms “reasonably understandable volume,” and “slow and deliberate manner.” The purpose of this amendment is to enable prescribers to fulfill their role as protectors of patients' eye health, since prescribers cannot correct and police invalid, inaccurate, and expired prescriptions if they cannot comprehend a seller's verification request. By requiring preservation of the recording, the amendment will also enable the Commission to better monitor seller compliance with the Rule. Fourth, the Commission proposes to amend the prohibition on seller alteration of prescriptions by specifying that alteration includes a seller providing the prescriber a verification request with the name of a manufacturer or brand other than that specified by the patient's prescriber, unless such name is provided because the patient entered it on the seller's order form, or because the patient orally gave the seller the other name in response to a request for the manufacturer listed on the patient's prescription. Lastly, in order to limit the burden of verification and ensure patient choice and flexibility, the Commission proposes to amend the Rule by requiring that sellers provide a mechanism that would allow patients to present their prescriptions directly to the seller. III. Option for Electronic Delivery of Prescriptions as a Means for Automatic Prescription Release In the NPRM, the Commission concluded that using online-patient portals to complete the automatic prescription release offered potential benefits for sellers, prescribers, and patients. 40 Prescribers could post, and patients could obtain, prescriptions online. With an electronic copy, patients could provide prescriptions more easily to sellers when purchasing lenses. 41 In turn, this potentially would reduce the volume of requests by sellers for verification or additional copies of the prescription. 42 To facilitate portability, the Commission noted that portals should allow patients to download, save, and print the prescription as well as send the prescription directly to a seller. However, the Commission did not have sufficient information to determine whether solely posting a contact lens prescription on a patient portal would be sufficient to satisfy the Rule's obligation for prescribers to provide a copy of a prescription to patients after completing a contact lens fitting. Therefore, the Commission sought comment on the use and adoption of online-patient portals as well as the potential ability for such technology to allow prescribers to comply with the automatic prescription-release requirement. 43 40 NPRM, 81 FR at 88535. 41 Id. 42 Id. 43 In the NPRM, the Commission also clarified that the “directly or by facsimile” language of § 315.5(a)(1) includes the use of online portals by patients and prescribers to present contact lens prescriptions to sellers. The Commission sought comments on this clarification. While the Commission received some comments, the Commission does not believe that any further modifications to this provision are necessary. A. Use of Patient Portals by Prescribers and Patients In response, several commenters noted the benefits and supported the use of patient portals. 44 Through a portal, patients would have greater access to their prescriptions and would have electronic copies to send to sellers. 45 However, commenters also expressed concerns that: (1) Online portals are not widely used; (2) patients may not be aware of the portal or may have difficulty accessing or printing medical documents online; and (3) prescribers and patients prefer paper copies. 46 Another commenter was concerned that allowing prescribers to satisfy the automatic prescription release by using an online portal would undercut the signed-acknowledgment requirement proposed in the NPRM. 47 44 Opticians Association of America (Workshop [hereinafter WS] Comment #482); CooperVision, Inc. (WS Comment #3077); Coalition for Contact Lens Consumer Choice (WS Comment #3239); Grove (NPRM Comment #1702); Opternative (NPRM Comment #3785); Comments of the Attorneys General of 20 States (NPRM Comment #3804); American Optometric Association (NPRM Comment #3830) (“For those doctors who have functioning patient portals and for patients who would like to use them, it would be beneficial for the Commission to clarify that providing access to a contact lens prescription through the patient portal would meet the prescriber requirements of automatic prescription release”); National Association of Optometrists and Opticians (NPRM Comment #3851); Costco Wholesale Corporation (NPRM Comment #4281) (“Patient portals are now commonplace among physician practices and could serve to enhance compliance with the Rule, as well as provide better information to sellers”). See also American Academy of Ophthalmology (NPRM Comment #3657) (some prescribers currently provide copies of prescriptions electronically, including through patient portals). 45 Opternative (NPRM Comment #3785); American Optometric Association (NPRM Comment #3830); 1-800 CONTACTS (NPRM Comment #3898); Consumers Union (NPRM Comment #3969) (“We see significant potential advantages of providing the prescription to the patient in electronic form, whether by email attachment or online patient portal.”). 46 Opternative (NPRM Comment #3785); American Optometric Association (NPRM Comment #3830); 1-800 CONTACTS (NPRM Comment #3898); Consumers Union (NPRM Comment #3969). 47 1-800 CONTACTS (NPRM Comment #3898). The Act and Rule clearly envision and support the use of electronic means to convey prescriptions. This is evident by the language of Section 7601(a)(2) of the Act, which requires prescribers to “provide or verify the contact lens prescription by electronic or other means” to patients' agents. 48 It would be inconsistent for the Act and Rule to permit prescribers to provide prescriptions electronically to patients' agents, but prohibit prescribers from electronically conveying prescriptions to patients themselves (or require that patients formally designate themselves as their own agent in order to receive an electronic copy of their prescription). 48 15 U.S.C. 7601(a)(2); 16 CFR 315.3(a)(2). Although online access to records has increased in the medical field generally, 49 the prevalence of portals among eye-care providers is unclear. 50 However, portal usage could increase as patients become more comfortable in interacting with their medical providers online and portal capabilities improve. 51 Several eye-care providers already offer copies of prescriptions through patient portals or other electronic means, including email. 52 49 One survey from 2017 found that 52% of individuals were offered online access to their medical records by a health provider or insurer, an increase from 42% in 2014. Of those patients who were offered online access, more than half actually viewed their online medical records at least once in the past year. U.S. Dep't of Health & Human Servs., The Office of the National Coordinator for Health Information Technology, “Individuals' Use of Online Medical Records & Technology for Health Needs” 1-2 (2018). 50 According to a survey conducted by 1-800 CONTACTS, thirty percent of patients were offered the option to use a patient portal at their last eye exam and, of those who had the option, 29% actually used it. 1-800 CONTACTS (NPRM Comment #3898). Comparatively, at the March 7, 2018 workshop, a panelist commented that only 8% of his office's patients used the portal. FTC, The Contact Lens Rule and the Evolving Contact Lens Marketplace, Panel V: Prescription Release & Consumer Choice Tr. at 17 (Mar. 7, 2018), https://www.ftc.gov/system/files/documents/public_events/1285493/panel_v_prescription_release_and_consumer_choice.pdf [hereinafter CLR Panel V Tr.]. 51 CLR Panel V Tr., supra note 50, at 18-19. 52 See, e.g., Eklund (WS Comment #502); Reed (WS Comment #749); Gitchell (WS Comment #759); Andrews (WS Comment #1014); Carvell (WS Comment #1021); Cecil (WS Comment #1892); Kuryan (WS Comment #3472); Hopkins (NPRM Comment #184); Wilson (NPRM Comment #1310); Grove (NPRM Comment #1702); MacDonald (NPRM Comment #2118); Andrus (NPRM Comment #3345); American Academy of Ophthalmology (NPRM Comment #3657) (“For practices that utilize electronic medical record systems, patients can request a copy of their prescription and [be] issued one electronically. Many practices also utilize patient portals to fill prescription requests.”). B. Analysis and Proposal Based on its review of the evidence, the Commission believes that the Rule should be amended to allow prescribers to satisfy § 315.3(a)(1)'s automatic-release requirement by providing the patient with a digital copy of the prescription, including by email, text, or patient portal, in lieu of a paper copy. 53 Importantly, the choice is not whether patients want to receive their prescriptions—since the Rule and statute both require that this be automatic—but rather the method of receiving them. To ensure that patients are not required to accept an unwanted method of delivery, the Commission would limit the use of electronic means to instances where the patient has given affirmative consent to receive a digital copy of the prescription. 54 The consent must be verifiable (so oral consent alone would not suffice), and the patient must be able to access, download, and print the digital copy for future use. Patients who decline to consent, for any reason, must receive a paper copy of their prescription. Likewise, because technology may be developing still or be costly to implement, prescribers who prefer to provide paper copies to their patients need not offer an electronic option. Therefore, the Commission invites comments on its proposed modification to allow prescribers to satisfy the automatic prescription release requirement by providing a digital copy in lieu of a paper copy when the patient gives verifiable affirmative consent. 55 53 In the NPRM, the Commission stated that allowing patients to send prescriptions to sellers through the portal would promote prescription portability. NPRM, 81 FR at 88535. Although potentially beneficial, the Commission's proposed change does not require that patients be able to send prescriptions to sellers through the portals. The technology that would allow this type of communication is still evolving, and potential complications exist, including software differences, the number of prescribers and sellers involved, and privacy issues. 1-800 CONTACTS (NPRM Comment #3898); CLR Panel V Tr., supra note 50, at 19-20. 54 The proposed change to allow for a digital copy in lieu of a paper copy does not alter the timing of when a prescriber must provide the prescription to the patient. In both instances, whether digital or paper, prescribers must provide the prescription immediately after completion of the contact lens fitting, or in the case of a renewal prescription, when the prescriber determines that no change in the existing prescription is required. The Commission's proposal would not expressly require that prescribers maintain records of patients' affirmative consent to electronic delivery, but prescribers may choose to do so in order to have proof that affirmative consent was given. Furthermore, the Commission's proposal would not alter or pre-empt existing state and federal statutes pertaining to the electronic delivery of records, such as the Electronic Signatures in Global and National Commerce Act, 15 U.S.C. 7001 (“E-Sign”). 55 Proposed changes to § 315.5(c) would require prescribers who provide digital copies of prescriptions to patients to retain evidence that the prescription was sent, received, or made accessible, downloadable, and printable. IV. Modification of Prior Signed-Acknowledgment Proposal A. NPRM Automatic Prescription Release Proposal and Comments In its December 2016 NPRM, the Commission proposed amending § 315.3(a)(1)—Automatic Prescription Release—to add the requirement that upon completion of a contact lens fitting, and after providing a copy of the contact lens prescription to the patient, the prescriber request that the contact lens patient acknowledge receipt of the contact lens prescription by signing an acknowledgment form entitled, “Patient Receipt of Contact Lens Prescription.” This form would state, “My eye care professional provided me with a copy of my contact lens prescription at the completion of my contact lens fitting. I understand I am free to purchase contact lenses from the seller of my choice.” In addition, the form would also include the name of the patient, the patient signature, and the date the form was signed. If the patient declined to sign the acknowledgment form, the prescriber would note the patient's refusal on the form and sign it. No other statements or information, other than the address or letterhead of the prescriber, would be placed on the acknowledgment form. 56 The Commission based its proposal on multiple findings. First, the Commission noted that commenters cited or submitted five surveys which, taken as a whole, suggested that a significant percentage of consumers were not receiving their prescriptions, and were unaware of their right to receive them. 57 The Commission acknowledged that none of the surveys, in and of itself, could be considered definitive, and acknowledged that there are inherent limitations to survey evidence. 58 Even so, the Commission concluded that the evidence was sufficient to indicate a significant problem with prescription-release compliance, particularly when the surveys were viewed in conjunction with supporting evidence from other sources and the lack of contradictory evidence. 59 56 NPRM, 81 FR at 88535. 57 NPRM, 81 FR at 88531-32. 58 Id. 59 NPRM, 81 FR at 88531. Supporting evidence cited by the Commission consisted of the following: The high number of seller verifications (many of which would be unnecessary were patients in possession of prescriptions and able to present them at purchase); 60 evidence that consumers are still unaware of their right to their prescriptions; 61 the ongoing pattern of consumer complaints and anecdotal reports of failure to release prescriptions; 62 and the industry's long and documented history of opposition to prescription release and failure to provide patients with prescriptions prior to the Rule's enactment, even when so obligated under state law. 63 The Commission also noted that current enforcement of the automatic-release provision is challenging, since the absence of any documentation makes it difficult to ascertain whether a prescriber did or did not release a prescription, and to determine how frequently a noncompliant party may have violated the Rule. 64 The Commission noted that under the current Rule, allegations and denials can become a matter of a patient's word against that of their prescriber. 65 60 Approximately three-quarters of third-party contact lens sales occur via prescriber verification, meaning that the consumer did not present a complete prescription at the time of the attempted purchase. Id. 61 According to an October 2015 survey by Survey Sampling International, an independent market research company retained by commenter 1-800 CONTACTS, 46% of contact lens wearers were unaware that they had a right to receive a copy of their prescription, even though the Rule has been in effect since 2004. Id. at 88532. 62 Id. 63 Id. 64 Id. at 88533. 65 Id. The Commission further concluded that the potential benefits of increasing the number of patients in possession of their prescriptions were substantial: Increased patient flexibility and choice in shopping for lenses; a reduced number of verification requests, which many prescribers find burdensome; a reduced likelihood of errors associated with incomplete or invalid prescriptions, which can jeopardize patient eye health; and a reduction in the number and complications of failed attempts at verification. 66 Increasing prescription-release compliance also would likely spur competition and innovation among contact lens sellers and manufacturers, and reduce attempts by sellers to verify incorrect, expired, and invalid prescriptions, or to verify with the wrong prescriber. 67 The Commission determined that the cumulative effect of increased automatic-release compliance would thus be lower costs and improved convenience and flexibility for patients, sellers, and prescribers, as well as increased accuracy of prescriptions presented to sellers, thereby reducing potential consumer harm. 68 Furthermore, a signed acknowledgment would increase the Commission's ability to assess and verify compliance with the Rule. 69 66 Id. at 88532. 67 Id. 68 Id. 69 Id. at 88533. The Commission estimated the burden of the proposed requirement at one minute per patient per year to obtain a signed receipt and save it to the patient's file, for a total overall burden on prescribers of 683,333 hours (41 million minutes) per year. 70 Based on average wages for prescribers, the Commission estimated this would result in an annual cost of $10,475,495, 71 roughly $176 per prescriber per year. 72 The Commission did not consider maintaining the form for three years to be a substantial new burden because a majority of state laws already require maintenance of eye exam records, and the Commission felt that maintaining a one-page two-sentence form should not take more than a few seconds of time, and an inconsequential, or de minimis, amount of record space. 73 The Commission concluded that the overall burden of the new requirement was relatively minimal and outweighed by the substantial benefit of having so many more patients in possession of their prescriptions. 74 70 Id. at 88557 (based on a Center for Disease Control and Prevention estimate of 40.9 million contact lens wearers in the U.S.); see also, Jennifer R. Cope et al., “Contact Lens Wearer Demographics and Risk Behaviors for Contact Lens-Related Eye Infections—United States, 2014,” Morb. Mortal. Wkly. Rep. 64(32):865-70, 866 (Aug. 21, 2015). 71 Id. at 88557 (based on 2015 Bureau of Labor Statistics data about the wage of office staff). If updated to 2017 BLS wage data, the annual cost estimate would be $11,138,328. 72 Based on government and industry estimates, there are 40,200 active optometrists and 19,216 active ophthalmologists in the United States. Bureau of Labor Statistics, U.S. Dep't of Labor, Occupational Outlook Handbook, Optometrists (2016-17 Ed.), https://www.bls.gov/ooh/healthcare/optometrists.htm; Am. Acad. of Ophthalmology, “Eye Health Statistics” (2015), https://www.aao.org/newsroom/eye-health-statistics#_edn25. Estimates can vary as to the current number of prescribers. At the CLR workshop, Wally Lovejoy, a consultant for the National Association of Optometrists and Opticians, put the figures at 43,000 optometrists and 16,700 ophthalmologists. FTC, The Contact Lens Rule and the Evolving Contact Lens Marketplace, Panel I: Overview of the Contact Lens Marketplace Tr. at 6 (Mar. 7, 2018), https://www.ftc.gov/system/files/documents/public_events/1285493/panel_i_overview_of_the_contact_lens_marketplace.pdf [hereinafter CLR Panel I Tr.]. The per-prescriber estimate does not take into account that a small percentage of optometrists and ophthalmologists do not prescribe contact lenses, and thus would not bear the burden of the requirement. 73 NPRM, 81 FR at 88557. 74 NPRM, 81 FR at 88534, 88557-58. The Commission further noted that while $10,475,495 was not insubstantial, it amounted to less than one-fourth of one percent of the overall retail market for contact lens sales in the United States. B. Comments on the Proposed Amendment to § 315.3(a)(1) 1. General Comments In response to its signed-acknowledgment proposal, the Commission received thousands of comments and has reviewed and considered each comment. Many commenters expressed support for the FTC's proposal, and said it would help effectuate the goal of the FCLCA by ensuring consumer choice and allowing contact lens retailers to better compete on price, service, and convenience. 75 Hundreds of contact lens consumers, in particular, expressed support for the Rule and the proposed amendment, with many stating that a signed acknowledgment would help ensure that prescribers release their prescriptions, enabling them to shop around and get the best price for their lenses. 76 75 See, e.g., CLR Panel V Tr., supra note 50, at 27 (statement of Linda Sherry calling it a “win-win” for both consumers and prescribers); FTC, The Contact Lens Rule and the Evolving Contact Lens Marketplace, Panel III: Competition in the Contact Lens Marketplace (Mar. 7, 2018) [hereinafter CLR Panel III Tr.] at 20 (statements of David Sonnenrich that “there's strong support among the states attorneys general for the proposed amendment”), https://www.ftc.gov/system/files/documents/public_events/1285493/panel_iii_competition_in_the_contact_lens_marketplace.pdf; Utah Retail Merchants Association (NPRM Comment #2312); Americans for Tax Reform (NPRM Comment #2847) (proposed changes would protect the successes of the FCLCA while giving consumers increased flexibility); Coalition for Contact Lens Consumer Choice (NPRM Comment #3718); Americans for Prosperity (NPRM Comment #3770); Office of Arizona Attorney General (NPRM Comment #3922). See also Blumenthal Letter, supra note 17 (expressing strong support for the signed-acknowledgment provision and applauding the FTC for “proposing pro-consumer and pro-market reforms to the Rule that will ensure robust competition . . . and help improve eye care providers' compliance”). 76 See e.g., Izquierdo (WS Comment #12); Clark (WS Comment #14); Clough (WS Comment #18); Forero (WS Comment #21); Ancona (WS Comment #27); Zeemering (WS Comment #34); Hauck (WS Comment #42); Brown (WS Comment #46); De Soto (WS Comment #49); Taylor (WS Comment #66); Cornwell (WS Comment #77); Chambers (WS Comment #91); Torres-Gambini (WS Comment #106); Hollier (WS Comment #113); Miranda (WS Comment #119); Green (WS Comment #134); Watson (WS Comment #138); Fisher (WS Comment #150); Gover (WS Comment #154); Pike (WS Comment #195); Klauscher (WS Comment #201); Kucewicz (WS Comment #215); Dawson (WS Comment #226); Pfeifer (WS Comment #246); Tennison (WS Comment #428); Florey (NPRM Comment #3520). Several commenters said the amendment is necessary because the market for contact lenses remains unique in that—unlike most other medical doctors—eye doctors sell the items they prescribe, and thus are rewarded financially for driving patients to their own retail channels. 77 According to one commenter, “relying on existing market forces and industry professional norms to advance the intent and purposes of the FCLCA and Contact Lens Rule does not work because prescribers have both an incentive and ability to limit consumer choice.” 78 77 Information Technology & Innovation Foundation (NPRM Comment #2848); Warby Parker (NPRM Comment #3867). See also Arizona State Representative Heather Carter (NPRM Comment #3193) (noting that in 2016, the 10th Circuit Court of Appeals held that the contact lens industry is uniquely anticompetitive in part because prescribers control the brand consumers use while also selling the lenses); Utah State Senator Curtis Bramble (NPRM Comment #576) (“The portability of a prescription is commonplace in almost every area where a prescription is needed, but often times it is hampered by the conflict that exists when a prescribing eye care provider has the opportunity to profit from the very product they're prescribing”); Rhode Island State Representative Brian Kennedy (NPRM Comment #3724) (citing “natural conflict of interest that exists in the industry”); Blumenthal Letter, supra note 17 (recognizing the “inherent conflict of interest” and noting that the FCLCA was made necessary by “the unique nature of the contact lens marketplace”). 78 Information Technology & Innovation Foundation (NPRM Comment #2848) (asserting that for those who would argue that more regulation is not the answer, the reason regulation is necessary in this instance is because the industry is already regulated, but in ways that give prescribers considerable power, since consumers cannot buy lenses without a prescription from their doctor). Prescribers, however, were generally 79 critical of the Commission's proposal, with many calling it an unnecessary burden that would also interfere with the doctor-patient relationship by implying that prescribers violate the law. 80 Many remarked that prescribers take an oath of professional conduct and abide by an ethical responsibility to place their patients' interests above their own. 81 Thus, many felt they were being unfairly maligned, and the proposal was tantamount to an attack on their integrity. 82 79 A few prescriber commenters supported the proposal, but these instances were rare. E.g., Richter (NPRM Comment #2706) (ophthalmologist supporting the proposal); Simple Contacts (NPRM Comment #3479) (online prescriber and seller supporting proposal); Opternative (NPRM Comment #3785) (online prescriber supporting the proposal). Other prescriber commenters, such as the National Association of Optometrists and Opticians, supported aspects of the proposed acknowledgment, but not the Commission's actual proposal. (NPRM Comment #3851). 80 See, e.g., CLR Panel V Tr., supra note 50, at 6 (statement of David Cockrell); Sorkin (WS Comment #602); Greenberg (WS Comment #628); Carlson (WS Comment #739); Johnson (WS Comment #755); Bryan (WS Comment #987); Martin (WS Comment #1168); Hill (WS Comment #1361); Armed Forces Optometric Society (NPRM Comment #2884); American Optometric Association (NPRM Comment #3830); Contact Lens Association of Ophthalmologists (NPRM Comment #4259). 81 See, e.g., Sclafani (WS Comment #631); Wright (WS Comment #743); Wardell (WS Comment #792); California Optometric Association (NPRM Comment #3845). 82 See, e.g., Dieckow (WS Comment #595) (“This is a witch hunt. It is quite parallel to the Spanish inquisition asking a village girl to prove she is not a witch”); Hallak (WS Comment #654) (“The proposed change to the contact lens release of information is ludicrous. The FTC should be ashamed for even consider [sic] it”); Owen (WS Comment #826) (“The FTC should recognize that we are not the enemy of consumers, but allies who are equally committed to protecting our patients' health and well-being”); Morabito (WS Comment #1135) (“This is a slap in the face of good people whose very purpose is to help people”); Holt (WS Comment #1375) (“having a patient sign a piece of paper that they are entitled to receive the contact lens prescription that they have already been given is just about the FTC and 1-800 trying to find a way to punish ODs for still being in existence”); Pirozzolo (WS Comment #1431) (“No other profession is required to have the patient sign an acknowledgment of receiving a prescription”). See also, e.g., Rosenblatt (WS Comment #841); Smoke (WS Comment #1184); Vosseteig (WS Comment #1205); Siegel (WS Comment #1391). 2. Comments Concerning the Need for the Proposed Signed Acknowledgment Due to Non-Compliance Several commenters asserted that the proposed signed-acknowledgment requirement is necessary because—even 14 years after creation of the Contact Lens Rule—prescribers often fail to release prescriptions automatically after a contact lens fitting. 83 A comment from the Attorneys General for 20 States, 84 for example, said they “are aware, from their enforcement efforts and collective experience, that not all patients receive their prescription in writing as a matter of course.” 85 Likewise, the CEO of a large contact lens seller, 1-800 CONTACTS, stated that the company performs “secret shops” of eye doctors and consistently finds that about 50% do not release prescriptions. 86 83 E.g., Institute for Liberty (NPRM Comment #2690); Citizen Outreach (NPRM Comment #3247); League of United Latin American Citizens (NPRM Comment #3326); Coalition for Contact Lens Consumer Choice (NPRM Comment #3718); Attorneys General for 20 States (NPRM Comment #3804); R Street Institute (NPRM Comment #3856); Warby Parker (NPRM Comment #3867); Consumers Union (NPRM Comment #3969). 84 Alabama, Delaware, Hawaii, Idaho, Illinois, Iowa, Maine, Maryland, Massachusetts, Minnesota, Montana, Nebraska, New Hampshire, New Mexico, New York, Oregon, Pennsylvania, Rhode Island, Vermont, and Virginia. Attorneys General for 20 States (NPRM Comment #3804). 85 Id. 86 CLR Panel III Tr., supra note 75, at 11 (statements of John Graham). Dozens of consumers also recounted personal stories in which they, or a family member, were either not provided with their prescriptions, experienced difficulty obtaining their prescriptions, or had to ask prescribers for them instead of receiving them automatically as required by law. 87 For example, one consumer said, “My experience has been that the majority of the time the contact lens prescription is not given out unless it's specifically requested and even then on some occasions the doctor's office is reluctant to release it,” 88 and another recounted, “I have fought with many a doctor and demanded a prescription and they still state that they will not do my eye exam unless I agree to purchase my contacts from them.” 89 Another commenter stated, “Each and every time I have gone to the eye doctor, I have had to ask for a copy of my prescription.” 90 Of those who had to ask for their prescriptions, several consumers complained that they felt uncomfortable making such a request or felt pressured into purchasing lenses from their prescriber and may have paid a higher price in consequence. 91 87 See, e.g., Keck (WS Comment #22); Mattox (WS Comment #28); Arthur (WS Comment #47); Barrett (WS Comment #259); Tyree (WS Comment #323); Fielding (WS Comment #376); Tennison (WS Comment #428); Lambrecht (WS Comment #448); Copley (WS Comment #515); Moses (WS Comment #875); Subowicz (WS Comment #926); Brotz (WS Comment #939); Bonner (WS Comment #982); Calk (WS Comment #984); Halston (WS Comment #1101); Gonzales (WS Comment #1437); Boue (NPRM Comment #1806); Collins (NPRM #1811); Herbst (NPRM Comment #1823); Tran (NPRM Comment #1829); Lozano-Adams (NPRM Comment #1831); Krainman (NPRM Comment #1847); Walker (NPRM Comment #1848); Zirbel (NPRM Comment #1849); Zeledon (NPRM Comment #1852); Diedrich (NPRM Comment #1856); Berry (NPRM Comment #1860); Montagnino (NPRM Comment #1866); Hochberg (NPRM Comment #1879); Bogner (NPRM Comment #1881); Rasczyk (NPRM Comment #1904); Fraga (NPRM Comment #1907); Vasquez (NPRM Comment #1917); Megraw (NPRM Comment #1933); Kasal (NPRM Comment #1937); Strobel (NPRM Comment #1940); Quinlog (NPRM #1963); Somerville (NPRM Comment #1966); Stanton (NPRM Comment #2001); Austin (NPRM Comment #2022); Cotten (NPRM Comment #2024); Bulmann (NPRM Comment #2045); Miller (NPRM Comment #2062); Robertson (NPRM Comment #2124); Capuano (NPRM Comment #2722); Martinez (NPRM Comment #2894); Woelfel (NPRM Comment #3131); Thomson (NPRM Comment #3421). 88 Rushton (NPRM Comment #2649). 89 Hamilton (NPRM Comment #1835). 90 Acton (NPRM Comment #2070). 91 E.g., Moses (WS Comment #875); Brotz (WS Comment #939); Calk (WS Comment #984); Fridley (WS Comment #988); Gonzales (WS Comment #1437); Vasquez (NPRM Comment #1917); Austin (NPRM Comment #2022); Ng (NPRM Comment #3289); James (NPRM Comment #4029). Many commenters also said the acknowledgment is necessary because consumers are often unaware of their right to their prescription. 92 One commenter admitted, “I did not know this was a law. I have been charged $25 extra for receiving my contact lens prescriptions before.” 93 Another anecdotal, but perhaps telling, indicator of the lack of consumer awareness, was the surprising number of consumer commenters who asked the Commission to pass a Rule requiring prescribers to release their prescriptions. 94 One consumer, for instance, wrote, “I strongly urge the FTC to adopt the rule that will require eye doctors to provide patients with a copy of their prescription,” 95 and another proclaimed, “Would love to be free to purchase my contacts wherever I choose. I can't stand that my prescription is held hostage by my eyecare provider! Please help!” 96 In other words, these commenters, and many others, filed comments urging the Commission to grant them a right that they already have, and have had since 2004, but apparently are not aware of. 92 St. Louis (NPRM Comment #3531); 1-800 CONTACTS (NPRM Comment #3898). See also, e.g., League of United Latin American Citizens (NPRM Comment #3326) (“Consumers who do not know their rights are being `trapped in the exam chair,' unaware that they can buy lenses elsewhere for lower prices.”); R Street Institute (NPRM Comment #3856) (“Consumers are insufficiently aware of their right to copies of their prescriptions, creating information asymmetries” between consumers and prescribers). 93 Monroe (NPRM Comment #4277). 94 See, e.g., Barrett (WS Comment #259); Pascucci (WS Comment #403); Biel (WS Comment #902); Randall (WS Comment #912); Rasczyk (WS Comment #913); Elliott (WS Comment #930); Slaydon (WS Comment #944); Palmer (WS Comment #956); Miller (WS Comment #1055); McBride (WS Comment #1088); Wilber (WS Comment #1162); Subach (WS Comment #1364); Krainman (NPRM Comment #1847); Boue (NPRM Comment #1806); Sattler (NPRM Comment #1808); Zeledon (NPRM Comment #1852); Vasquez (NPRM Comment #1917); Herron (NPRM Comment #1982); Tardif (NPRM Comment #2011); Burlingame (NPRM Comment #3115). 95 Ballou (NPRM Comment #3331). 96 Boue (NPRM Comment #1806). a. Empirical Evidence of Compliance In terms of empirical evidence, two commenters submitted new consumer surveys conducted by third-party polling firms, both of which reported that a substantial percentage of consumers do not receive prescriptions after a contact lens fitting as required by law. 97 One survey, submitted by 1-800 CONTACTS, reported that only 37% of patients automatically received a copy of their prescriptions after a contact lens fitting. 98 The other survey, submitted by Consumer Action, reported that just 44% of consumers received prescriptions without having to ask for them. 99 According to the surveys, when consumers who did not receive prescriptions asked for them, prescribers typically complied. 100 But even counting those who asked for their prescriptions and subsequently received them, 24-31% of consumers—roughly 10-12 million patients a year—never received a copy of their prescriptions and were thus unable to comparison shop for lenses. 101 This data is generally consistent with previous consumer surveys discussed in the NPRM, such as the October 2015 Survey Sampling International survey, submitted by 1-800 CONTACTS, which found that 35% of consumers automatically received a prescription, 28% received one after asking for it, and 36% did not receive one at all. 102 97 Consumer Action (NPRM Comment #3721); 1-800 CONTACTS (NPRM Comment #3898). 98 1-800 CONTACTS (NPRM Comment #3898, Ex. A). Data is based on an online survey performed by the polling firm Survey Sampling International (“SSI”) on behalf of 1-800 CONTACTS. According to 1-800 CONTACTS, the survey was conducted during December 2016 and sampled 1000 contact lens wearers. 99 Consumer Action (NPRM Comment #3721). Data is based on a Caravan ORC International telephone survey of 2018 adults performed in January 2017. See also CLR Panel V Tr., supra note 50, at 2 (statements of Linda Sherry). 100 See Consumer Action (NPRM Comment #3721) (showing that 21% of total patients had to ask the prescriber for their prescription, and 20% of total patients received it upon request); 1-800 CONTACTS (NPRM Comment #3898, Ex. A) (showing that 36% of total patients had to ask for their prescription, and 31% of total patients received it immediately upon request, while 5% were told to call the office or return at a later time to receive a copy). 101 See Consumer Action (NPRM Comment #3721); 1-800 CONTACTS (NPRM Comment #3898, Ex. A). The 10-12 million calculation is based on the estimate that there are currently 41 million contact lens wearers in the United States and that each patient receives one contact lens fitting a year. The Commission uses this estimate here since it used the same figures to assess the burden of the Rule. In actuality, it is probably less, since some contact lens wearers go longer than twelve months between fittings. 102 NPRM, 81 FR 88531-32. Data was based on a SSI online survey of 500 contact lens wearers in 2015. As noted in the NPRM, the manner in which the questions were phrased in this particular survey raised some Commission concerns, since some of them were leading, lacked an “I don't know” option, and used a term—“hard copy”—which not all patients may understand. Id. at 88531 n.73. The Consumer Action survey also found that 60% of consumers responded “no” when asked, “Are you aware that under federal law, a doctor or exam provider is required to automatically provide their patient with a copy of their prescription after they get their contact lens exam?” 103 1-800 CONTACTS cited a previously submitted survey, which found that 46% of contact lens wearers were unaware that they had a right to receive a “hard copy” of their prescription. 104 103 Consumer Action (NPRM Comment #3721). Data is based on a Caravan ORC International telephone survey of 2018 adults performed in January 2017. Thirty-eight percent said “yes,” and 2% responded “I don't know” or refused to answer. The Commission has some concerns that the question was leading, but also notes that it is possible that the 60%-unaware result actually underestimates the number of consumers unaware of their rights. This is due to social desirability bias, the tendency of survey respondents to answer questions in a manner that will be viewed favorably by others. As noted in the NPRM, respondents may be reluctant to admit that they are unaware of their rights under the law. NPRM, 81 FR at 88532. 104 1-800 CONTACTS (NPRM Comment #3898). Data is based on a SSI online survey of 500 contact lens wearers in 2015. NPRM, 81 FR at 88532. Various prescriber commenters criticized the polling evidence as “unreliable,” 105 and said the aforementioned surveys are tainted by the interests of their sponsors. 106 According to two prescriber associations, evidence submitted by 1-800 CONTACTS should not be deemed reliable because the submitter is a “stakeholder” rather than a disinterested party and has a history of aggressively seeking competitive advantages. 107 The American Optometric Association (“AOA”) further noted that Consumer Action—a non-profit consumer advocacy organization—has received corporate financial support from, among others, 1-800 CONTACTS. 108 105 CooperVision, Inc. (NPRM Comment #3841). See also Coalition for Patient Vision Care Safety (NPRM Comment #3883) (“the quality of evidence is not sufficient to support the need for this requirement”). 106 American Academy of Ophthalmology (WS Comment #2971) (“It is our opinion that evidence should not include industry-sponsored surveys, seeking a specific result, to propel a specific narrative for their benefit.”); American Optometric Association (WS Comment #3303) (“We question the legitimacy of the information on alleged non-compliance that 1-800 CONTACTS has provided to the Commission.”). 107 American Academy of Ophthalmology (WS Comment #2971); American Optometric Association (WS Comment #3303). In particular, the AOA argues that surveys conducted on behalf of 1-800 CONTACTS are not credible because: (1) The FTC has previously sued 1-800 CONTACTS for anti-competitive practices against other contact lens retailers ( see https://www.ftc.gov/enforcement/cases-proceedings/141-0200/1-800-contacts-inc-matter ); (2) 1-800 CONTACTS supports online vision examinations and thus might have a financial interest in discrediting brick-and-mortar optometrists; and (3) the Arizona Board of Optometry concluded that many complaints about prescriber non-compliance that 1-800 CONTACTS filed with the board were unfounded. See also Bhadra (WS Comment #801) (“I find it disingenuous that these online retailers have flooded the public with fake news that ODs are not giving patients their contact lens prescriptions.”). 108 American Optometric Association (WS Comment #3303). The AOA also asserted that consumer surveys may be unreliable because they are based on patient-reported data and—as the Commission has previously recognized—patients might not always understand that they are entitled to a copy of their prescription only after their contact lens fitting has been fully completed. 109 To rebut these surveys and demonstrate that prescribers are complying, the AOA submitted a survey of fifty-seven “high-volume optometrists,” in which 93% said “yes” when asked, “Do you follow Federal law and provide patients with a copy of their contact lens prescription upon completion of a contact lens fitting?” 110 109 Id. See also CooperVision, Inc. (NPRM Comment #3841) (stating Commission overstates evidence of noncompliance by not distinguishing between initial visits to prescribers and subsequent contact lens fittings in which the prescription is finalized); NPRM, 81 FR at 88530-31 (noting that consumers are not always aware of when they are entitled to their prescriptions). 110 American Optometric Association (WS Comment #3303, App. B). This survey appears to have been conducted by the AOA itself rather than an outside polling firm. It is not clear from the AOA's submission how the fifty-seven optometrists were selected for the survey, what it means to be a “high volume” optometrist, or why high volume optometrists were chosen. As the Commission acknowledged in its NPRM, all surveys have limitations with respect to methodology and evidence, and, in this instance, the Commission does not treat any one survey as definitive. Patients may sometimes misremember details of a particular encounter with a prescriber, and prescribers may be mistaken about the particulars of a given clinical encounter or about the frequency with which they do or do not release prescriptions. For the most part, the submitted surveys do not include independent objective tests of patient or prescriber recollections. In addition, survey responses may be sensitive to the ways in which questions are framed. Despite what some commenters recommend, however, the Commission does not dismiss survey evidence based solely on the source of its submission. While the Commission is cognizant of the interests of submitting parties, the Commission examines the underlying survey data and methodology to gauge a survey's usefulness. In the case of the consumer surveys, which were conducted by established third-party polling firms, the submitters provided the Commission with the underlying questions, responses, and statistical data, as well as details about survey methodology. Based on its review of the submitted material, the Commission finds that the two new consumer surveys represent an improvement over previously submitted consumer surveys. In particular, the new surveys include an option for respondents to acknowledge that they do not recall whether they received their prescriptions and use the term “paper copy” rather than “hard copy,” a term the Commission has previously noted some patients may not understand. The number of consumers polled is also larger than some previous surveys. The Commission further recognizes that the new surveys are generally consistent with the findings of previously-submitted surveys, and that multiple surveys conducted by different sources at different times with similar results bolster the credibility of each individual survey. The Commission also has not received any consumer-survey data rebutting these findings or indicating that consumers consistently receive their prescriptions in satisfactory numbers. The Commission therefore accords the overall submitted consumer-survey data significant weight. In contrast, the Commission finds the AOA-submitted survey of prescribers less useful as a tool to assess compliance with the prescription-release requirement. The Commission has several concerns. Besides concerns about the small sample size (fifty-seven) and lack of detail as to how prescriber respondents were recruited, the Commission notes that the way the question is phrased 111 allows prescribers to truthfully answer that they provide patients with a copy of their prescription even if they do not do so for every patient, and even if they only do so when the patient requests one. Moreover, the wording of the survey question makes it highly unlikely a prescriber would admit to not releasing prescriptions. As noted (in a different context) in the NPRM, asking a respondent if he or she is aware of their rights or obligations under the law can skew responses, since respondents may be unwilling to admit they are ignorant of the law or violate it. 112 In this instance, prescribers also have a clear incentive to say they follow Federal law even if they do not (whereas consumers do not have a clear incentive to say that prescribers are not providing them with their prescriptions). Based on the wording and framing of the question in the AOA survey, the Commission is surprised that even 7% of prescribers answered that they do not provide patients with their prescriptions, a result that, if extrapolated to the population of prescribers, would still mean that every year more than 2.7 million consumers are denied their prescriptions—and their ability to comparison-shop for more affordable contact lenses—in violation of the law. 113 111 “Do you follow Federal law and provide patients with a copy of their contact lens prescription upon completion of a contact lens fitting?” 112 See NPRM, 81 FR at 88532. 113 This calculation is based on estimates that there are currently 41 million contact lens wearers in the United States and that each patient gets one contact lens fitting a year. See supra note 101. Apart from the three surveys, no other commenter submitted empirical evidence of automatic-release compliance or consumer awareness. 114 Several commenters, nonetheless, strongly opined that the Commission lacks “compelling evidence” that the signed acknowledgment is needed 115 and said they are “unaware” of significant compliance problems among eye-care professionals. 116 Numerous prescribers also declared that, personally, they consistently release prescriptions to patients after each contact lens fitting, and believe their colleagues do the same. 117 Several prescribers were also firm in their belief that patients are fully aware they have a right to their prescription, 118 with some noting that advertising and marketing from third-party sellers help remind patients of their rights. 119 Many prescribers thus proclaimed that the signed- acknowledgment proposal was a waste of resources, both for prescribers and the Commission, 120 and called it a “solution in search of a problem.” 121 Other commenters said that even if it is true that a small number of prescribers do not comply with the automatic-release requirement, the proposed acknowledgment requirement would be, in effect, “punishing the masses for the sins of the few.” 122 114 At the CLR Workshop, some audience members commented that in their state, the prescription release rate was 100%. Commission staff asked that this data be provided, but it never was. See CLR Panel V Tr., supra note 50, at 23. Another commenter, Lens.com, commented that more than half of its customers “report that optometrists still do not provide prescriptions as required by law.” (NPRM Comment #2358). However, Lens.com could not provide the Commission with information about how it surveyed its customers and exactly what consumers reported, so the Commission has not relied on this evidence. 115 McGrew (WS Comment #713). See also, e.g., American Society of Cataract and Refractive Surgery (WS Comment #3142); Davies (WS Comment #3307); Utah Ophthalmology Society (NPRM Comment #2586); American Academy of Ophthalmology (NPRM Comment #3657); CooperVision, Inc. (NPRM Comment #3841). 116 See, e.g., Cooperman (NPRM Comment #2382); American Academy of Ophthalmology (NPRM Comment #3657); American Society of Cataract and Refractive Surgery (NPRM Comment #3820); American Optometric Association (NPRM Comment #3830); Wisconsin Academy of Ophthalmology (NPRM Comment #4152); Kentucky Academy of Eye Physicians and Surgeons (NPRM Comment #4276). 117 E.g., Palys (WS Comment #560); Widmann (WS Comment #618); Nixon (WS Comment #687); Bausback (WS Comment #708); Lo (WS Comment #856); Hanian (WS Comment #1196); Carkner (WS Comment #1287); Myers (WS Comment #1322); Leung (WS Comment #1600); Randle (WS Comment #2171); Stamm (WS Comment #2512); Swan (WS Comment #2843); Olson (WS Comment #2970); Wisniewski (NPRM Comment #1769). Over sixty prescribers also submitted identical, or nearly identical, comments which included the following statement, “First, I would like to make clear that I comply with the requirements of the Fairness to Contact Lens Consumers Act (FCLCA) and the corresponding Contact Lens Rule by providing copies of contact lens prescriptions to contact lens wearing patients at the end of the contact lens fitting process.” E.g., Shepherd (WS Comment #483); Alexander (WS Comment #468); Morton (WS Comment #488); Skrdla (WS Comment 492); Smith (WS Comment #493); Hertneky (WS Comment #494); Eklund (WS Comment #502); Buchanan (WS Comment #520); Borden (WS Comment #865); Bryan (WS Comment #987); (Redmond (WS Comment #989). 118 E.g., Lonsk (WS Comment #596); Friederich (WS Comment #614); Highsmith (WS Comment #690); Bedsole (WS Comment #1024); Phillips (WS Comment #1151); Sumner (WS Comment #1332); Hill (NPRM Comment #3561). 119 California Academy of Eye Physicians and Surgeons (NPRM #4269) (online retailers are “not shy” about letting consumers know they have a right to their prescriptions). See also Dinh (WS Comment #1653); Ulc (WS Comment #2347). 120 See, e.g., To (WS Comment #597); DeKinder (WS Comment #625); Bausback (WS Comment #708). 121 E.g., Kaminski (WS Comment #607); Bank (WS Comment #653); Melman (WS Comment #667); Nixon (WS Comment #687); Hamilton (WS Comment #781); Martin (WS Comment #1168); McMahon (WS Comment #1868); Randle (WS Comment #2171); Jones (WS Comment #3079); Cervantes (WS Comment #3125); Khong (WS Comment #3435). See also e.g., Larson (WS Comment #716); Ambler (WS Comment #2329); Fritsch (WS Comment #2543); Hornstein (WS Comment #2666). 122 McKinnis (WS Comment #786). See also, e.g., Wesley (WS Comment #835); Kline (WS Comment #852); Holcomb (WS Comment #872); Edwards (WS Comment #884); Boyce (WS Comment #1466); Woodward (NPRM Comment #273); McLaughlin (NPRM #1365); Blankenship (NPRM Comment #2117); Armed Forces Optometric Society (NPRM Comment #2884); Sonsino (NPRM Comment #3783); Sterna (NPRM Comment #3892). Prescriber assertions about overwhelming compliance with the automatic-release requirement are undermined somewhat by the large number of prescriber commenters who misstated the Rule and said that they “offer” prescriptions to their patients or provide them “when requested,” rather than provide them automatically after each fitting. 123 Ten state ophthalmology associations commented that the signed acknowledgment is unnecessary because eye doctors in their states are providing patients with their prescriptions “ when requested in full compliance with the Contact Lens Rule” 124 (emphasis added). Both the Act and the Rule specifically require that a prescription be provided to each patient “whether or not requested by the patient,” and the Commission does not have authority to amend the statute or disregard this obligation. 123 See, e.g., Moore (WS Comment #544); Heiby (WS Comment #694); Larson (WS Comment #716); Krisciunas (WS Comment #1085); Pebley (WS Comment #1261); Horibe (WS Comment #3242); Mitsoglou (NPRM Comment #480); Frieman (NPRM Comment #2589); Cooper (NPRM Comment #2673). 124 Utah Ophthalmology Society (NPRM Comment #2586); South Dakota Academy of Ophthalmology (NPRM Comment #2588); Michigan Society of Eye Physicians and Surgeons (NPRM Comment #4165); Florida Society of Ophthalmology (NPRM Comment #4197); Iowa Academy of Ophthalmology (NPRM #4199); Oklahoma Academy of Ophthalmology (NPRM Comment #4204); Pennsylvania Academy of Ophthalmology (NPRM Comment #4214); Indiana Academy of Ophthalmology (NPRM Comment #4233); Massachusetts Society of Eye Physicians and Surgeons (NPRM Comment #4270); Kentucky Academy of Eye Physicians and Surgeons (NPRM Comment #4276). b. Verifications as Evidence of Lack of Prescription Release Many prescribers also contend that the Commission erred in its NPRM finding that the large number of contact lens sales conducted via verifications is evidence of lack of prescription release. According to these commenters, the number of verifications does not reflect lack of prescription release since some consumers may lose their copies and some online sellers promote the ease (for the consumer) of the verification method. 125 In contrast, some sellers stated that from a business standpoint, they prefer and encourage patients to present prescriptions rather than rely on verification, since it is faster for the consumer and less costly for the seller. 126 1-800 CONTACTS, for instance, promotes presentation at checkout as a way for consumers to get their lenses more quickly, and has run promotional campaigns offering consumers a discount on lens orders if they would send in a copy of their prescription. 127 Additionally, several commenters, including some prescribers, agreed that a signed acknowledgment would likely reduce the percentage of sales via verification, indicating that some percentage of consumers are not receiving their prescriptions at their contact lens fitting. 128 Nevertheless, the Commission recognizes that it can be more cumbersome for a consumer to locate and upload a prescription than to simply type in the name of their prescriber and their prescription information—which they can obtain from their contact lens boxes—and thus some consumers may opt for verification even though they did receive a copy of their prescription. The Commission is also aware that some online contact lens sellers do not currently have a mechanism for patients to present their actual prescriptions, and rely solely on verification. Thus, while the Commission will still consider the large percentage of third-party contact lens sales conducted via verification 129 as suggestive of prescriber failure to release prescriptions, the Commission will accord it less weight than it did in the NPRM. 125 American Optometric Association (NPRM Comment #3830) (sellers promote verification as an easy way to get refills). 126 See FTC, The Contact Lens Rule and the Evolving Contact Lens Marketplace, Panel IV: Examining the Verification Process Tr. at 6-7 (Mar. 7, 2018), https://www.ftc.gov/system/files/documents/public_events/1285493/panel_iv_examining_the_verification_process.pdf [hereinafter CLR Panel IV Tr.] (statement of Jennifer Sommer); id. at 6-7, 22 (statement of Cindy Williams). 127 Id. at 6-7. 128 See, e.g., CLR Panel V Tr., supra note 50, at 9 (statement of David Cockrell that it would absolutely reduce the number of verifications, but would not eliminate them, since patients often lose their prescription copies); National Association of Optometrists and Opticians (WS Comment #3208); Costco Wholesale Corporation (NPRM Comment #4281). 129 NPRM, 81 FR at 88531 (estimated at roughly three-quarters of third-party sales). c. The Dearth of Consumer Complaints to the FTC as Evidence of Prescriber Compliance Several commenters made the point that, in proportion to the total number of contact lens users in the United States, there have been relatively few consumers—only a few hundred—who actually filed complaints with the Commission about prescribers' failing to release prescriptions, and since 2007, only fifty-five prescribers have received FTC warning letters about possible non-compliance. 130 According to these commenters—the American Optometric Association, in particular—the small percentage of complaining consumers and Commission warning letters indicates that prescribers, for the most part, are complying with the automatic prescription-release requirement. 131 130 American Optometric Association (WS Comment #3303); (American Optometric Association, NPRM Comment #3830). According to AOA's analysis of consumer complaints filed with the Commission, from 2012-2016, there have been only 309 complaints relating to prescriber failure to release prescriptions, and only .0003% of the 41 million contact lens wearers, approximately 123 patients, filed what the AOA regarded as potentially valid complaints about a prescriber's failure to release a prescription. See also, e.g., Stubinski (WS Comment #1701); Fritsch (WS Comment #2543); Higley (WS Comment #2857); Tran (WS Comment #3106). 131 American Optometric Association (WS Comment #3303). See also e.g., Stubinski (WS Comment #1701); Fritsch (WS Comment #2543); Higley (WS Comment #2857); Tran (WS Comment #3106); CLR Panel IV Tr., supra note 126, at 23 (statement of David Cockrell that “if it was a real problem for patients, you would have an enormous number of complaints”). The AOA complaint figures were also cited by a number of other commenters, as well as by several legislators who sent letters to the Commission. See, e.g., Cook (WS Comment #7); To (WS Comment #597); Smith (WS Comment #732); Gordon (WS Comment #1694); Toon (WS Comment #1741); Mattson (WS Comment #1784); Letter from Twenty-Four Members of the United States House of Representatives Regarding the Contact Lens Rule Rulemaking Proceeding and the Proposed Rule Set Forth in the Notice of Proposed Rulemaking (Sept. 17, 2018). https://www.ftc.gov/system/files/filings/initiatives/677/congress_letter_to_chairman_simons_re_ftc_contact_lens_rule_9-17-2018.pdf [hereinafter Letter from Twenty-Four Representatives]; Letter from Seven Members of the United States House of Representatives Regarding the Contact Lens Rule Rulemaking Proceeding and the Proposed Rule Set Forth in the Notice of Proposed Rulemaking (July 27, 2018). https://www.ftc.gov/system/files/filings/initiatives/677/denham_ftc_fclca_code_of_regulations_regarding_contact_lens_prescription.pdf [hereinafter Letter from Seven Representatives]; Letter from Fifty-Four Members of the United States House of Representatives Regarding the Contact Lens Rule Rulemaking Proceeding and the Proposed Rule Set Forth in the Notice of Proposed Rulemaking (May 10, 2018). https://www.ftc.gov/system/files/filings/initiatives/677/contact_lens_letter_may_10_2018.pdf [hereinafter Letter from Fifty-Four Representatives]; Letter from Senator David Perdue of the United States Senate Regarding the Contact Lens Rule Rulemaking Proceeding and the Proposed Rule Set Forth in the Notice of Proposed Rulemaking (Nov. 17, 2017), https://www.ftc.gov/system/files/filings/initiatives/677/public_comment_filed_by_senator_david_perdue_in_the_contact_lens_rulemaking.pdf; Letter from Senator John Boozman of the United States Senate Regarding the Contact Lens Rule Rulemaking Proceeding and the Proposed Rule Set Forth in the Notice of Proposed Rulemaking (Aug. 3, 2017), https://www.ftc.gov/system/files/filings/initiatives/677/boozman_letter_contact_lens_rule_8-3-17.pdf [hereinafter Boozman Letter]; Letter from Fifty-Eight Members of the United States House of Representatives Regarding the Contact Lens Rule Rulemaking Proceeding and the Proposed Rule Set Forth in the Notice of Proposed Rulemaking (July 24, 2017), https://www.ftc.gov/system/files/filings/initiatives/677/r511995_contact_lens_rule_letter_from_58_representatives_7-24-17.pdf [hereinafter Letter from Fifty-Eight Representatives]. Other commenters, such as 1-800 CONTACTS, 132 challenged that assertion and contended that there are many reasons consumers do not file formal complaints each time a prescriber fails to provide a prescription. To support this, 1-800 CONTACTS submitted a report by Stanford University Professor Laurence Baker, which opined that consumers are unlikely to register formal complaints because they (1) may not know they are entitled to a copy of the prescription, (2) may not know who to complain to in the event they do not receive their prescription, (3) may be reluctant to create ill-will between them and their doctor, and (4) may calculate that the time and effort of registering a complaint outweigh any benefit they are likely to obtain. 133 132 1-800 CONTACTS (WS Comment #3207). 133 Laurence C. Baker, “Analysis of Costs and Benefits of the FTC Proposed Patient Acknowledgment and Recordkeeping Amendment to the Contact Lens Rule,” 11 (2017), https://www.ftc.gov/system/files/summaries/initiatives/677/meeting_summary_for_the_contact_lens_rulemaking_proceeding.pdf [hereinafter Baker Analysis]. The Commission understands and recognizes the prescriber-commenters' position that there are relatively few consumer complaints, but believes that consumer complaints, on their own, are a poor reflection of prescriber compliance or non-compliance with the Rule. The Commission has gleaned, through its extensive experience with consumer complaints and deceptive practices, that the vast majority of injured or impacted consumers do not file complaints with the government. According to a 2004 FTC report, only 8.4% of U.S. fraud victims complained to an official source, with only 1.4% complaining to the FTC. 134 Likewise, the FTC's 2011 Fraud Survey reported that 25.6 million Americans were victimized by fraud that year, 135 yet the FTC received only 1.3 million fraud complaints. 136 Furthermore, with the notable exception of the Telemarketing Sales Rule (often referred to as “Do Not Call”), consumer complaints about FTC rule violations are even more uncommon, perhaps because they require that consumers know what an FTC rule specifies and how it has been violated. 137 Indeed, of the many consumer commenters to the NPRM—some fifty-one of whom are cited above 138 —who recounted personal stories in which they, or a family member, faced obstacles obtaining their prescription, not one of them appears to have registered a complaint with the FTC. 139 While the Commission regards consumer complaints as extremely valuable and informative, it is aware that they often represent just the tip of the iceberg. 134 Keith B. Anderson, FTC, “Consumer Fraud in the United States: An FTC Survey” 80 (2004), http://www.ftc.gov/reports/consumer-fraud-united-states-ftc-survey. 135 Keith B. Anderson, FTC, “Consumer Fraud in the United States, 2011: The Third FTC Survey” 18 (2013), https://www.ftc.gov/sites/default/files/documents/reports/consumer-fraud-united-states-2011-third-ftc-survey/130419fraudsurvey_0.pdf. 136 This includes all the complaints about identity theft, which are sometimes catalogued differently than fraud. FTC, “Consumer Sentinel Data Book for January—December 2011” 5 (2012), https://www.ftc.gov/sites/default/files/documents/reports/consumer-sentinel-network-data-book-january-december-2011/sentinel-cy2011.pdf. 137 See generally, id.; FTC, “Consumer Sentinel Network Data Book for January-December 2016” (2017), https://www.ftc.gov/system/files/documents/reports/consumer-sentinel-network-data-book-january-december-2016/csn_cy-2016_data_book.pdf. Consumer reticence to complain, particularly to a government entity, is well documented. See Marc A. Grainer et al., “Consumer Problems and Complaints: a National View,” 6 Advances in Consumer Res. 494 (1979) (noting that “only a small, vocal minority of consumers complain about the problems they experience,” and even fewer (less than 10% of complaints) complain to the government), http://acrwebsite.org/volumes/9603/volumes/v06/NA-06. See also John Goodman & Steve Newman, “Understand Customer Behavior and Complaints,” Quality Progress, Jan. 2003), at 51 (finding that for problems that resulted in a relatively minor inconvenience or a small loss of money, only 3% of consumers complained), http://web.ist.utl.pt/~ist11038/CD_Casquilho/PRINT/qp0103goodman.pdf. 138 See supra notes 87-90. 139 The Commission has been unable to locate any prior complaints about prescription release filed by any of the consumer commenters to the NPRM, but complaint records typically only go back five years, and thus the Commission cannot ascertain with absolute certainty whether any of them ever registered a complaint in the past. Furthermore, as evidenced by the aforementioned consumer surveys, many contact lens wearers (46-60%) do not realize they are entitled to receive their prescription, and thus would not even be aware that an incident about which they should complain had occurred, and many others might be unaware of where to direct a complaint when they do not receive a prescription. While many prescriber commenters assert that consumers know their rights, the Commission has not received empirical evidence contradicting the consumer surveys. Lastly, even consumers who are aware that they have a right to their prescription are unlikely to file complaints with the Commission if they ultimately receive their prescription after they have asked for them. From their perspective, they have resolved their problem and may perceive little benefit to themselves from filing a government complaint. Consumers may also not want to risk antagonizing their doctors or subjecting their eye-care providers to legal penalties. Thus, for evaluating Contact Lens Rule compliance—more so than for some other Commission circumstances—the low rate of consumer complaints is less probative of the scope of the problem than consumer survey evidence. 140 140 Consumer surveys may also be more reliable since consumers questioned at random are less likely to have a personal interest in stating that they did not receive their prescription. Relying on consumers to remedy their own injury by asking for their prescriptions, however, is problematic. Many consumers are uncomfortable asking for prescriptions, since it signals to the prescriber that they plan to purchase lenses elsewhere. 141 Many consumers have a good relationship with their prescribers and do not want to do something that might be viewed as disloyal. Others may not want to openly acknowledge that they are concerned about the cost of purchasing contact lenses. Moreover, relying on patients to ask for their prescriptions effectively re-writes the FCLCA requirement that prescribers release prescriptions automatically, and amends it to release-upon-request. This would directly contravene Congressional intent and the text of the Act, which specifically states that prescriptions are to be given “whether or not requested by the patient.” 142 When the Commission considered such a change with respect to prescription release under the Eyeglass Rule (which the Commission does have the authority to amend), the Commission repeatedly rejected such an approach as inappropriate since it shifts the burden of prescription-release enforcement to the consumer. 143 141 See supra note 91. 142 15 U.S.C. 7601(a)(1). 143 See Eyeglass I, 43 FR at 23998 (stating that relying upon release-upon-request is problematic because many consumers are unaware of their right to a prescription, and because the right should be “immunized from an evidentiary squabble over whether the consumer actually did or did not request the prescription”); Final Trade Regulation Rule, Ophthalmic Practice Rules 54 FR 10285, 10286-87 (Mar. 13, 1989) [hereinafter Eyeglass II] (rejecting a proposal to change the Rule to release-upon-request and finding a “continuing need” for automatic release). See also Contact Lens Rule, 69 FR at 40492 (discussing a commenter proposal to allow prescribers to not release the prescription or release it “for informational purposes only” if the patient has purchased a full year's supply of contact lenses at the time of the examination, and rejecting it because “such an exception would be contrary to the Act's express requirement that consumers receive a copy of their prescription at the completion of a contact lens fitting”). 3. Comments Concerning Whether a Proposed Signed Acknowledgment Is Needed for Better Enforcement and Auditing of the Rule In its December 2016 NPRM, the Commission noted that a signed acknowledgment would increase the Commission's ability to assess and verify compliance with the Rule. 144 Several commenters agreed, suggesting that the signed-acknowledgment proposal is necessary because the prescription-release requirement is currently difficult or impossible to enforce. 145 According to one commenter, prescribers have little incentive to comply with automatic release because compliance could result in lost sales, and absent some evidentiary record, an FTC enforcement action is extremely unlikely. 146 Another commenter noted that while the Commission has sent warning letters in response to complaints about lack of prescription release, the Commission has yet to bring an enforcement action or seek fines against a prescriber for failure to release contact lens prescriptions. 147 According to some commenters, the Commission needs an auditable process in order to enforce the Rule and the FCLCA. 148 To demonstrate how the current Rule lacks teeth, one commenter, 1-800 CONTACTS, commented that it conducted a follow-up “secret shop” of twenty-one of the forty-five prescribers who received FTC warning letters in 2016, and found that even after receiving these warnings, eighteen still failed to automatically release a prescription after completion of a contact lens fitting. 149 Some commenters also suggested that a signed record would actually help prescribers by giving them a way to prove that they provided the prescription, and thus prevent consumers from incorrectly alleging that a prescriber violated the law. 150 144 NPRM, 81 FR at 88532. 145 See, e.g., Information Technology and Innovation Foundation (NPRM Comment #2848); Arizona State Rep. Heather Carter (NPRM Comment #3193); Semelsberger (NPRM Comment #3856); 1-800 CONTACTS (NPRM Comment #3898). 146 Warby Parker (NPRM Comment #3867). 147 1-800 CONTACTS (NPRM Comment #3898). The Commission has brought one case against a prescriber for failure to release eyeglass prescriptions in violation of the Eyeglass Rule, and resolved the suit with a consent decree and $10,000 penalty. United States v. Doctors Eyecare Ctr. Inc., No. 96-cv-012224-D (N.D. Tex. June 25, 1996). It is also worth noting that warning letters are typically sent in response to consumer complaints, and, as noted supra, for a number of reasons, consumers are unlikely to complain to the Commission when they do not receive their prescriptions. 148 See Information Technology and Innovation Foundation (NPRM Comment #2848); 1-800 CONTACTS (NPRM Comment #3898); Costco Wholesale Corporation (NPRM Comment #4281). See also CLR Panel III Tr., supra note 75, at 12 (“there needs to be a mechanism for enforcement”). 149 Baker Analysis, supra note 133, at 10. 150 CLR Panel V Tr., supra note 50, at 27 (statements of Linda Sherry); Consumers Union (NPRM Comment #3969). Other commenters, however, suggested that the Commission could do a better job of enforcing the current release requirement instead of adding a signed-acknowledgment requirement. 151 One commenter suggested that instead of the signed acknowledgment, the Commission should conduct its own “secret shops” of prescriber offices and fine those who fail to release prescriptions. 152 151 See e.g., Bernard (WS Comment #588); Click (WS Comment #876). 152 Pearl (WS Comment #824). Several prescribers also suggested that the signed-acknowledgment requirement itself would be difficult to enforce 153 or that it was unlikely that prescribers who do not currently comply with prescription release would comply with the signed-acknowledgment requirement. 154 Similarly, some prescribers doubted whether consumers would read the signed-acknowledgment document and thus questioned its use for education purposes. 155 153 Missouri Optometric Association (NPRM Comment #1208). 154 See, e.g., Pearl (WS Comment #824); Koch (WS Comment #855); Holcomb (WS Comment #872); Edwards (WS Comment #884); Alwes (WS Comment #998); Jones (WS Comment #2778); Contact Lens Association of Ophthalmologists (NPRM Comment #4259); California Academy of Eye Physicians and Surgeons (NPRM Comment #4269). 155 CLR Panel V Tr., supra note 50, at 9 (statements of Zachary McCarty); Gasparini (WS Comment #825); Schweiger (WS Comment #993). 4. Comments About the Burden of the Signed-Acknowledgment Proposal A significant number of commenters felt that the Commission underestimated the burden that the signed-acknowledgment requirement would impose on prescribers, and said the actual burden would be much more “substantial.” 156 According to commenters, the Commission's estimate 157 did not fully recognize the time it would take to train office staff, answer consumers' questions, and create, produce and store the acknowledgment form for three years. 158 The National Association of Optometrists and Opticians (“NAOO”) predicted the acknowledgment requirement would add five minutes to each transaction “because of the need to explain the reason for the signature to the patient,” 159 and stressed that “storage of the myriad pieces of paper is not a small burden.” 160 156 American Academy of Ophthalmology (NPRM Comment #3657). See also, e.g., American Society of Cataract and Refractive Surgery (NPRM Comment #3820) (“will have significant cost implications”); CLR Panel V Tr., supra note 50, at 6 (statement of David Cockrell) (“I think it creates a very significant burden.”); Rohler (NPRM Comment #377); Stott (NPRM Comment #687). 157 The Commission's estimate was forty-one million minutes per year, based on an estimate of 41 million contact lens wearers and one minute to present each patient with the form, obtain a signature, and scan or store the record. NPRM, 81 FR at 88557. The Commission stated that in all likelihood, the burden would actually be far less, since the Commission did not credit the reduction in verification burden that would likely occur once additional consumers were in possession of their prescriptions. Additionally, not all contact lens wearers obtain eye exams every year. In 2017, for instance, there were approximately 34 million contact lens eye exams in the U.S. CLR Panel I Tr., supra note 72, at 5 (statements of Steve Kodey). If the number of actual exams had been used to calculate the burden, this would have reduced the estimated burden to 34 million minutes. See also 1-800 CONTACTS (NPRM Comment #3898) (estimating that the average exam frequency for contact lens patients is 15 months, citing https://www.clspectrum.com/issues/2016/november-2016/four-strategies-for-practice-growth ); CLR Panel IV Tr., supra note 126, at 3 (statements of Cindy Williams) (stating that evidence indicates the majority of contact lens wearers get an exam once every 12-16 months). 158 See, e.g., National Association of Optometrists and Opticians (WS Comment #3208); Toepfer (NPRM Comment #652); Slusser (NPRM Comment #149); Armed Forces Optometric Society (NPRM Comment #2884); American Society of Cataract and Refractive Surgery (NPRM #3820); American Optometric Association (NPRM Comment #3830); California Optometric Association (NPRM Comment #3845). 159 National Association of Optometrists and Opticians (NPRM Comment #3851). 160 Id. Several prescribers predicted they would incur thousands of dollars in staff time, printing, and electronic records costs, although most did not provide a detailed basis for their estimates. 161 Some commenters also questioned why the Commission was imposing a paper-storage requirement when so many physicians—at the urging of health authorities—are moving toward electronic records, and spending significant amounts of money to make that transition. 162 Others said they already make the prescription available electronically via patient portals, so this would just generate unnecessary paper waste. 163 161 See, e.g., Wright (WS Comment #743); Wesley (WS Comment #835); Norman (WS Comment #1285); Paulsen (WS Comment #1335); Dice (WS Comment #1585); Loomis (WS Comment #3300); California Optometric Association (NPRM #3845). 162 E.g., Akers (WS Comment #577); Rule (WS Comment #775); Schindler (WS Comment #1160); Ball (WS Comment #2861). 163 E.g., Nau (WS Comment #683); Carvell (WS Comment #1021). See also Chuang (WS Comment #864). A number of commenters predicted that the burden would force prescribers to raise patient fees to cover increased administrative costs. 164 Some also felt it was unfair that prescribers, who currently shoulder a larger financial share than sellers of the costs imposed by the Rule, would now be responsible for even more. 165 Some commenters said that by imposing this new burden, it would be harder for prescribers to compete with third-party sellers, and thus the proposal could hinder competition rather than foster it, and some prescribers might have to stop selling lenses. 166 Many prescribers also criticized the proposed signed acknowledgment because they said it would not improve patient health or address what they believe are questionable practices by third-party retailers that put patients' eye health at risk. 167 Many of these commenters suggested that the Commission re-approach the Rule review with patient safety as the number one priority. 168 164 See, e.g., Mitchell (WS Comment #238); Anders (WS Comment #479); Bjork (WS Comment #591); Giusto (WS Comment #740); Reed (WS Comment #749); Smith (WS Comment #1245); Paulsen (WS Comment #1335); Hamilton (WS Comment #2017); Joe (WS Comment #2340); Webster (WS Comment #2515); Ritter (WS Comment #2888); American Optometric Association (NPRM Comment #3830). 165 See Utah Ophthalmology Society (NPRM Comment #2586); American Optometric Association (NPRM Comment #3830). 166 See, e.g., Koch (WS Comment #855); Willingham (WS Comment #858); Heltsley (WS Comment #1028); American Optometric Association (NPRM Comment #3830); Teed (NPRM Comment #4232). 167 See, e.g., Wright (WS Comment #743) (“Instead of going after doctors that take an oath, are held to high standards and depend on excellent patient care reputation to retain patients, the FTC should be going after the unscrupulous contact lens sellers that put profits far ahead of patient eye health concerns”); Satjawatcharaphong (WS Comment #1030) (“There is no justification for targeting eye doctors . . . while the Commission allows retailers who blatantly violate the law to operate unchecked.”); Vosseteig (WS Comment #1205) (“These proposed changes are NOT in the best interests in the patient, and are attacking optometry, instead of the retailers who consistently and constantly abuse the unenforced rules already in place. Do not target eye doctors! New paperwork and document storage requirements are NOT going to protect the patient, but will only add cost and time to an already broken health system.”). See also McLoughlin (WS Comment #1311); Utah Ophthalmology Society (NPRM Comment #2586); American Society of Cataract and Refractive Surgery (NPRM Comment #3820); California Optometric Association (NPRM Comment #3845); Simsarian (NPRM Comment #3902); Foster (NPRM Comment #3981); Nakano (NPRM Comment #4353). 168 Utah Ophthalmology Society (NPRM Comment #2586). A few commenters also said the new requirement would add a burden to consumers, since they would not want to sign another form 169 or might have to return to their prescribers' offices to sign the acknowledgment receipt, whereas currently some contact lens fittings are finalized remotely (via phone, text, or email) after the patient takes home trial lenses for a few days. 170 Other commenters contested this assessment, stating that the percentage of consumers who complete their contact lens fitting remotely is small (by one estimate just 9%), and that prescribers who complete a fitting remotely could satisfy the signed-acknowledgment requirement by retaining proof that they transmitted the actual prescription to the patient. 171 169 Kampa (NPRM Comment #3042); Mecham (NPRM Comment #3419); Dang (NPRM Comment #3508); Warner (NPRM Comment #3533). 170 Fortier (NPRM Comment #363); Dingley (NPRM Comment #342); Wisconsin Academy of Ophthalmology (NPRM Comment #4152). 171 1-800 CONTACTS (NPRM Comment #3898, Ex. B). Results are based on an online panel study of 753 optometrists between December 12, 2016 and January 4, 2017. See also CLR Panel V Tr., supra note 50, at 11 (statements of David Cockrell that he would be “really surprised” if less than 80%-90% of contact lens fittings are completed in person); Simple Contacts (NPRM Comment #3479) (requirement could be satisfied remotely with “little additional effort”); Opternative (NPRM Comment #3785) (“they can be sent and completed either electronically or via hardcopy in the office at the end of a fitting and added to a patient's existing medical record, which most states require to be kept for at least three years”). On the issue of burden, the AOA submitted a third-party survey and analysis conducted by Avalon Health Economics (the “Avalon Report”), which reported that optometrists expect it will take 3.12 minutes to explain to each patient the purpose of the signed acknowledgment, 3.41 minutes to answer questions from patients who seek more information, and 13.31 minutes of training to teach staff how to correctly address patient concerns about the acknowledgment (although only 44% of optometrists said additional training would be necessary). 172 According to the AOA, the analysis shows that the cost of implementing the signed-acknowledgment proposal could be as high as $18,795 for a practice with one optometrist, and as high as $49,913 for a practice with three optometrists. 173 Approximately 85% of this estimated burden, however, came not from training, explaining, or answering questions about the signed acknowledgment, but rather from the general cost of “total administrative time associated with adhering to the rules, regulations and policies regarding the operation of your practice.” 174 In other words, the bulk of the burden derived not from the new signed-acknowledgment requirement, but from adhering to rules and regulations in general, including existing rules and regulations. 175 172 American Optometric Association (NPRM Comment #3830). According to the AOA, the survey was disseminated to approximately 1000 optometrists, of whom 130 responded. The survey asked them to describe how much time it takes them to introduce a new patient engagement process and conduct periodic assessments of such a process, and how much time they anticipate they and their staff would spend answering questions and explaining the purpose of the signed acknowledgment to patients. It also asked them for the “total administrative time associated with adhering to the rules, regulations and policies.” 173 American Optometric Association (NPRM Comment #3830). 174 Id. 175 The AOA burden estimate was also cited by numerous other commenters as evidence that the acknowledgment proposal would be extremely burdensome for prescribers, and disproportionate to the harm caused by prescriber failure to release prescriptions. See, e.g., Letter from Seven Representatives, supra note 131; Letter from Fifty-Four Representatives, supra note 131; Boozman Letter, supra note 131; Letter from Fifty-Eight Representatives, supra note 131. After its own review of the Avalon Report, the Commission doubts its reliability and usefulness. Of greatest concern is that the bulk of the estimated burden is derived not from the signed-acknowledgment proposal, but rather from responses to the survey's open-ended question regarding total indirect costs of adhering to government regulations. As noted, these encompass regulations that are already in place and already taking prescriber adherence time, but may be unrelated in any way to the Commission's proposal. Furthermore, the survey also asked prescribers to predict whether patients would have questions, rather than surveying patients themselves as to whether they would have questions. Moreover, the relatively small sample of optometrists who responded to the survey (130) knew the sponsor and purpose of the survey beforehand. In fact, the AOA had urged its members to comment on the NPRM and provided them with a sample letter declaring that the Commission's NPRM burden estimate did not sufficiently account for “ongoing staff training” and the “additional step in the patient engagement process.” 176 Thus, Avalon survey respondents may have been unduly influenced to inflate the burden of complying with existing regulations and the proposed new one. Based on these and other concerns, 177 the Commission cannot accord significant weight to many of the survey's findings or cost estimates, although it will still consider whether to include training time in its determination of the overall burden and need for the proposal. 176 E.g, Mass Mail Campaign (NPRM Comment #283) (1,415 submissions). See also, e.g., Shaw (NPRM Comment #314); Schwartz (NPRM Comment #321); Yin (NPRM Comment #326); Singh (NPRM Comment #340); Stahl (NPRM Comment #355); Moore (NPRM Comment #365); Brozzo (NPRM Comment #366); Rohler (NPRM Comment #377); Woo (NPRM Comment #400); Heeg (NPRM Comment #407); Le (NPRM Comment #416); Lemke (NPRM Comment #441); Durham (NPRM Comment #473); Mueller (NPRM Comment #513); Williams (NPRM Comment #411); Kirsch (NPRM Comment #495); Bond (NPRM Comment #497); Palys (NPRM Comment #538); Kanevsky (NPRM Comment #555); Nordwall (NPRM Comment #576); Johnson (NPRM Comment #613); Bate (NPRM Comment #647); Toepfer (NPRM Comment #652); Korley (NPRM Comment #653); Wegener (NPRM Comment #665); Melman (NPRM Comment #676); Williams (NPRM Comment #703); Ballard (NPRM Comment #756); Cass (NPRM Comment #757). 177 The analysis did not account for the fact that 16% of optometrists do not believe consumers will have additional questions about the signed acknowledgment. The survey also does not supply information on the mean and variance of the open-ended question regarding time. If any respondents significantly overestimated the time spent adhering to rules, those figures would distort the overall average, particularly since only 130 optometrists participated. In marked contrast to the views of prescribers, other commenters called the Commission's signed-acknowledgment proposal a measured approach that would be easy to administer and impose a relatively minor burden. 178 According to the consumer advocacy organization Consumers Union, “The burden of having copies of the one-page form available in the eye doctor's office, having each patient sign a copy of the form when receiving the prescription, and keeping that copy in a file for three years, is minimal and entirely manageable, and will enable more effective enforcement of the rule while also making it easier for eye doctors to show compliance.” 179 Likewise, other commenters stated that such a requirement should be easy to administer, particularly if prescribers use an electronic device to present the acknowledgment and record the signature electronically. 180 Other commenters felt that the signed acknowledgment would be similar to the HIPAA acknowledgment that prescribers are already obtaining from each patient, and thus would not cause an excessive burden.” 181 178 See e.g., Information Technology & Innovation Foundation (NPRM Comment #2848). Citizen Outreach (NPRM Comment #3247); Thompson (NPRM Comment #3302); Searrles (NPRM Comment #3304); Simple Contacts (NPRM Comment #3479); Coalition for Contact Lens Consu [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%3A2019-09627. Public record. Not legal advice.