Contact Lens Rule, 50668-50718 [2020-14206]

Download as PDF 50668 Federal Register / Vol. 85, No. 159 / Monday, August 17, 2020 / Rules and Regulations FEDERAL TRADE COMMISSION 16 CFR Part 315 RIN 3084–AB36 Contact Lens Rule Federal Trade Commission (‘‘FTC’’ or ‘‘Commission’’). ACTION: Final rule. AGENCY: The FTC is publishing a final rule to implement amendments to the Contact Lens Rule. These amendments require that prescribing eye care practitioners obtain a confirmation of prescription release from patients after releasing a contact lens prescription and maintain each such acknowledgment for a period of not less than three years. The Commission is permitting prescribers to comply with automatic prescription release via electronic delivery in certain circumstances. Further, these amendments specify a time period for prescribers to respond to requests for prescriptions; clarify and institute additional requirements for automated telephone verification messages; more precisely delineate what constitutes unlawful alteration of a prescription; and require that sellers provide a method for, and notice of the method for, patient prescription presentation. DATES: This rule is effective October 16, 2020. ADDRESSES: Relevant portions of the record of this proceeding, including this document, are available at https:// www.ftc.gov. FOR FURTHER INFORMATION CONTACT: Alysa Bernstein (202–326–3289), abernstein@ftc.gov, Paul Spelman (202– 326–2487), pspelman@ftc.gov, or Andrew Wone (202–326–2934), awone@ ftc.gov, Bureau of Consumer Protection, Federal Trade Commission, 600 Pennsylvania Avenue NW, Washington, DC 20580. SUPPLEMENTARY INFORMATION: SUMMARY: Table of Contents I. Background A. Overview of the Contact Lens Rule B. History of the Rule C. Initial Request for Comments in 2015 D. Notice of Proposed Rulemaking in 2016 E. Supplemental Notice of Proposed Rulemaking II. Final Rule Pertaining to Confirmation of Prescription Release A. Proposed Modifications in the SNPRM B. Basis for SNPRM Confirmation of Prescription Release Proposal C. Comments on the Confirmation of Prescription Release Proposal and the Basis for Such Proposal 1. Comments About the Need for the Confirmation of Prescription Release and Whether Prescribers Are Complying VerDate Sep<11>2014 20:17 Aug 14, 2020 Jkt 250001 With the Rule’s Automatic Prescription Release Requirement a. Survey Evidence as Proof of NonCompliance b. Lack of Consumer Complaints as Evidence of Compliance c. Number of Verifications as Evidence of Non-Compliance With the Automatic Prescription Release Requirement 2. Comments About the Need To Improve the Commission’s Ability To Monitor Compliance and Enforce the Rule 3. Comments About Whether the Structure of the Contact Lens Market Creates a Need for Verifiable Enforcement of Automatic Prescription Release 4. Comments About the Text of the Proposed Confirmation of Prescription and the Option To Include the Confirmation as Part of a Patient’s Prescription or Sales Receipt 5. Comments About Option (D) and Using Electronic Delivery for Confirmation of Prescription Release a. Use of Patient Portals and Patient Consent b. Requirement To Maintain Records of Patient Consent 6. Comments About Alternatives to the Confirmation of Prescription Release a. Signage b. Educational Programs as an Alternative to Confirmation of Prescription Release 7. Comments About the Burden and Benefits of the Confirmation of Prescription Release Proposal 8. Comments About the Exemption for Prescribers Who Do Not Have a Direct or Indirect Financial Interest in the Sale of Contact Lenses D. Additional Discussion and Commission Determination Regarding the Confirmation of Prescription Release Proposal III. Additional Requirements for Sellers Using Verification Calls Containing Automated Messages A. The Congressional Record Does Not Support Prohibiting Automated Telephone Messages B. Comments About, and Adoption of, Requirements Proposed in the SNPRM To Improve Quality of Automated Telephone Messages C. The Commission’s Proposal Requiring Sellers To Record Automated Telephone Messages D. The Final Rule Does Not Adopt Commenters’ Additional Recommendations Regarding Automated Telephone Messages IV. Prescribers’ Selection of Communication Mechanism V. Miscellaneous Passive Verification Issues A. Active Verification Is Not Required B. Concerns About Patient Manipulation C. Eight-Business-Hour Time Frame Is Appropriate VI. Seller Alteration of Contact Lens Prescriptions and Private Label Concerns A. The Final Rule Includes a Requirement for Sellers To Accept Prescription Presentation B. Alteration Includes a Seller Providing a Prescriber With a Verification Request for a Non-Prescribed Manufacturer or PO 00000 Frm 00002 Fmt 4701 Sfmt 4700 Brand, but Includes an Exception for Verifying a Manufacturer or Brand That a Consumer Indicates Is on Her Prescription 1. The Final Rule Modifications Regarding Alteration Are Beneficial and Address Abuses of the Verification System 2. Comments Related to the Exception to Alteration When a Seller Provides the Manufacturer or Brand of Lenses That a Consumer Provides in Response to a Seller’s Request for That Information 3. Comments Regarding and Commission Guidance on Acceptable Methods for Obtaining the Brand or Manufacturer Listed on Consumers’ Prescriptions 4. The Commission Is Not Imposing a Recordkeeping Requirement for Sellers Related to the Exception C. Private Label Issues 1. The Commission Adopts a Technical Amendment and Clarifies That the Only Permissible Substitution Involves Private Label Lenses 2. The Commission Is Not Imposing Additional Requirements on Prescriptions for Private Label Lenses VII. ‘‘Directly or by Facsimile’’ Language Includes Use of Online Patient Portals to Present Prescriptions VIII. Requests for an Additional Copy of a Prescription A. Benefits of an Additional Copy and the Time Period To Respond to a Request B. Requirement To Maintain Records IX. Excessive Quantity X. Expiration of Contact Lens Prescriptions A. Length of Contact Lens Prescriptions B. Sales Using Expired Contact Lens Prescriptions XI. Paperwork Reduction Act A. Confirmation of Prescription Release and Affirmative Consent to Digital Delivery of a Prescription 1. SNPRM Burden Estimate for the Confirmation of Prescription Release 2. Comments Regarding the SNPRM Estimate for the Confirmation of Prescription Release Requirement 3. Estimated Additional Burden Hours for the Confirmation of Prescription Release Requirement 4. Estimated Total Labor Cost Burden for the Confirmation of Prescription Release Modification 5. Capital and Other Non-Labor Costs for the Confirmation of Prescription Release Requirement B. Recording of Automated Telephone Messages C. Total Burden for the Modifications to the Rule XII. Regulatory Flexibility Act A. Need for and Objectives of the Rule Amendments 1. Amendments Affecting Prescribers 2. Amendments Affecting Sellers B. Significant Issues Raised by Public Comments in Response to the IRFA, Including Any Comments Filed by the Chief Counsel for Advocacy of the Small Business Administration, and the Agency’s Response, Including Any Changes Made in the Final Rule Amendments 1. Amendments Affecting Prescribers E:\FR\FM\17AUR2.SGM 17AUR2 Federal Register / Vol. 85, No. 159 / Monday, August 17, 2020 / Rules and Regulations 2. Amendments Affecting Sellers C. Description and Estimate of the Number of Small Entities to Which the Amendments Will Apply or Explanation Why No Estimate Is Available D. Description of the Projected Reporting, Recordkeeping and Other Compliance Requirements of the Amendments, Including an Estimate of the Classes of Small Entities That Will Be Subject to the Requirement and the Type of Professional Skills Necessary for Preparation of the Report or Record 1. Amendments Affecting Prescribers 2. Amendments Affecting Sellers E. Steps Taken To Minimize the Significant Impact, if Any, of the Amendments, Including Why Any Significant Alternatives Were Not Adopted 1. Steps and Alternatives for Amendments Affecting Prescribers 2. Steps and Alternatives for Amendments Affecting Sellers XIII. Congressional Review Act I. Background A. Overview of the Contact Lens Rule In 2003, Congress enacted the Fairness to Contact Lens Consumers Act (‘‘FCLCA’’ or ‘‘Act’’),1 and pursuant to the Act, the Commission promulgated the Contact Lens Rule on July 2, 2004.2 The Rule went into effect on August 2, 2004. The Contact Lens Rule (‘‘Rule’’) promotes competition in retail sales of contact lenses by facilitating consumers’ ability to comparison shop for contact lenses. When an eye care practitioner (‘‘prescriber’’) 3 completes a contact lens fitting, the Rule requires that the prescriber automatically provide the patient with a portable copy of the patient’s prescription, whether or not the patient requests it.4 The Rule also requires that the prescriber verify or provide such prescriptions to authorized third parties. At the same time, the Rule requires that sellers only sell contact lenses in accordance with 1 15 U.S.C. 7601–7610 (Pub. L. 108–164). 2 Contact Lens Rule, 16 CFR part 315 (2015). 3 Under the Rule, prescriber is defined as an ophthalmologist, optometrist, or other person permitted under State law to issue prescriptions for contact lenses in compliance with any applicable requirements established by the Food and Drug Administration. ‘Other person,’ in this context, includes dispensing opticians who are permitted under State law to issue prescriptions and who are authorized or permitted under State law to perform contact lens fitting services. 16 CFR 315.2. 4 The Commission also notes that apart from requiring that the contact lens fitting be complete, the FCLCA and Rule do not include any other requirements or exceptions that would permit a prescriber to withhold a patient’s contact lens prescription following a fitting. 16 CFR 315.3(a)(1). Therefore, prescribers must automatically provide patients with copies of their prescriptions following their fitting, regardless of whether patients indicate an intention to purchase contact lenses—no matter the quantity (and even an annual supply)—from their prescribers. VerDate Sep<11>2014 20:17 Aug 14, 2020 Jkt 250001 valid prescriptions written by licensed prescribers that were either (a) presented to the seller by the patient or a designated agent of the patient or (b) verified by direct communication with the prescriber.5 The Rule further sets out the information that must be included in a seller’s verification request, and directs that a prescription is only verified under the Rule if: (1) The prescriber confirms the prescription is accurate; (2) the prescriber informs the seller that the prescription is inaccurate and provides an accurate prescription in its stead; or (3) the prescriber fails to communicate with the seller within eight business hours after receiving a compliant verification request.6 The Rule states that if the prescriber informs the seller within eight business hours of receiving the verification request that the prescription is inaccurate, expired, or invalid, the seller shall not fill the prescription. The Rule requires that the prescriber specify the basis for the inaccuracy or invalidity of the prescription, and if the prescription is inaccurate, the prescriber must correct it.7 Sellers may not alter a prescription, but for private label contact lenses, may substitute identical contact lenses that the same company manufactures and sells under a different name.8 The Contact Lens Rule sets a minimum expiration date of one year after the issue date of a prescription with an exception based on a patient’s ocular health.9 The Rule also incorporates the Act’s preemption of state and local laws and regulations that establish a prescription expiration date of less than one year or that restrict prescription release or require active verification.10 B. History of the Rule The FTC has more than three decades of regulatory and research experience regarding the optical goods industry; this history continues to inform the basis and purpose of the Contact Lens Rule and this rule review. In addition to the Rule, the Commission enforces the Ophthalmic Practice Rules (known as the ‘‘Eyeglass Rule’’), initially promulgated in 1978.11 Prior to the 5 16 CFR 315.5(a). CFR 315.5(b)–(c). 7 16 CFR 315.5(d). 8 16 CFR 315.5(e). 9 16 CFR 315.6. 10 16 CFR 315.11(a). The Rule also preempts any other state or local laws or regulations that are inconsistent with the Act or the relevant section of the Rule, to the extent of the inconsistency. 16 CFR 315.11(b). 11 Final Trade Regulation Rule, Advertising of Ophthalmic Goods and Services, 43 FR 23992 (June 6 16 PO 00000 Frm 00003 Fmt 4701 Sfmt 4700 50669 Eyeglass Rule, surveys of optometrists found that a majority of prescribers imposed some restriction on the availability of the patient’s prescription, usually by either refusing to release prescriptions or charging an additional fee to do so.12 Prescribers also used waivers and liability disclaimers to discourage comparison shopping, mislead consumers, and frighten them into purchasing ophthalmic goods from the prescriber.13 The Commission determined that these actions reduced consumers’ ability to obtain the lowest prices and hindered competition in the optical marketplace.14 To address these problems, the Eyeglass Rule required prescribers—generally, optometrists and ophthalmologists—to provide each of their patients, immediately after completion of an eye examination, a free copy of the patient’s eyeglass prescription.15 The Eyeglass Rule, however, did not encompass contact lens prescriptions. While a majority of states enacted their own statutes requiring some form of contact lens prescription release,16 many prescribers continued to withhold prescriptions for contact lenses.17 This, 2, 1978) [hereinafter Eyeglass I]. The Rule was revised in 1992, with the revisions codified at 16 CFR part 456. Ophthalmic Practice Rules, 57 FR 18822 (May 1, 1992). 12 43 FR at 23998. See also FTC, ‘‘Staff Report on Advertising of Ophthalmic Goods and Services and Proposed Trade Regulation Rule’’ 240–48 (1977) [hereinafter 1977 Staff Report] (detailing myriad accounts of prescribers refusing to release eyeglass prescriptions to their patients), https://www.ftc.gov/ system/files/documents/reports/staff-reportadvertising-ophthalmic-goods-services-proposedtrade-regulation-rule-16-cfr-part-456/r611003-staff_ report_on_advertising_of_ophthalmic_goods_and_ services_and_proposed_trade_regulation.pdf. 13 43 FR at 23998; Am. Optometric Ass’n v. FTC, 626 F.2d 896, 916 (D.C. Cir. 1980) (noting considerable ‘‘evidence of abuse’’ by prescribers); see also 1977 Staff Report, supra note 12, at 277. 14 FTC, ‘‘The Strength of Competition in the Sale of Rx Contact Lenses: An FTC Study’’ 45–46 (2005), https://www.ftc.gov/sites/default/files/documents/ reports/strength-competition-sale-rx-contact-lensesftc-study/050214contactlensrpt.pdf [hereinafter 2005 Contact Lens Report]. 15 16 CFR 456.2 (separation of examination and dispensing). The FTC also has studied the effects of state-imposed restrictions in the optical goods industry. See FTC, ‘‘The Effects of Restrictions on Advertising and Commercial Practice in the Professions: The Case of Optometry’’ (1980), https:// www.ftc.gov/sites/default/files/documents/reports/ effects-restrictions-advertising-and-commercialpractice-professions-case-optometry/ 198009optometry.pdf. 16 By 2003, more than two-thirds of states had laws requiring some form of contact lens prescription release. H.R. Rep. No. 108–318, 108th Cong., 1st Sess. 4 (2003), at 8 (2003). 17 See id. at 4 (noting that ‘‘[t]he practice of optometrists withholding the prescription [for contact lenses] has limited the consumer’s ability to shop for the best price and has impacted competition’’); Fairness to Contact Lens Consumers Act: Hearing Before the Subcomm. on Commerce, E:\FR\FM\17AUR2.SGM Continued 17AUR2 50670 Federal Register / Vol. 85, No. 159 / Monday, August 17, 2020 / Rules and Regulations 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 thirdparty sellers), made it challenging for consumers to obtain lenses from anyone other than their prescribers.18 According to Congress, these obstacles were rooted in an ‘‘inherent conflict of interest’’ in that ‘‘[u]nlike medical doctors who are prohibited from selling the drugs they prescribe, eye doctors and optometrists . . . are able to fill the contact lens prescriptions they write.’’ 19 Third-party sellers are thus forced to compete for the sale of lenses with the individual who is writing the prescription.20 To address this inherent conflict of interest and achieve freedom of choice and the benefits of competition for contact lens consumers, Trade, and Consumer Protection of the H. Comm. on Energy and Commerce, 108th Cong. 1 (2003) [hereinafter FCLCA Subcomm. Hearing] (statement of Ami Gadhia, Consumers Union) (noting that multiple surveys of consumers in Texas had found considerable numbers were unable to obtain their contact lens prescription from their prescribers). 18 H.R. Rep. No. 108–318, at 4; FCLCA Subcomm. Hearing, supra note 17 (statements of Howard Beales, Jonathan Coon, Ami Gadhia, Robert Hubbard, Maria Martinez, Rep. W. J. Tauzin; Peggy Venable). See also In re Disposable Contact Lens Antitrust Litig., No. 94–MDL 1030–J–20A (M.D. Fla.), in which the Attorneys General of 31 states alleged that eye-care professionals engaged in an organized effort to prevent or hinder consumers from obtaining their contact lens prescriptions. The complaints alleged two conspiracies: (1) That the practitioners and their trade associations conspired to prevent the release of contact lens prescriptions to consumers, and (2) that manufacturers, practitioners, and trade associations, including the American Optometric Association, conspired to eliminate sales of contact lenses by pharmacies, mail order, and other alternative sellers. Id. According to the Attorneys General, the conspiracy severely restricted the supply of contact lenses available to alternative sellers, which hampered the growth of such sellers, decreased the supply of lenses to consumers, and increased the price of lenses. Id. The parties reached settlements, the last of which the court approved in November 2001. As part of the settlements, manufacturers agreed to sell contact lenses to alternative distribution channels. 19 H.R. Rep. No. 108–318, at 5. See also Letter from Senators Richard Blumenthal and Orrin G. Hatch of the United States Senate Regarding the Contact Lens Rule Rulemaking Proceeding and the Proposed Rule Set Forth in the Notice of Proposed Rulemaking (Aug. 11, 2017) (recognizing the ‘‘inherent conflict of interest’’ and noting that the FCLCA was made necessary by ‘‘the unique nature of the contact lens marketplace’’), https:// www.ftc.gov/system/files/filings/initiatives/677/ public_comment_from_senators_blumenthal_and_ hatch_re_contact_lens_rulemaking.pdf [hereinafter Blumenthal Letter]. 20 H.R. Rep. No. 108–318, at 4; FCLCA Subcomm. Hearing, supra note 17 (statements of Rep. W.J. Tauzin) (noting there is a ‘‘classic conflict of interest that robs the consumers of the ability to shop competitively for the best price,’’ and stating that the FCLCA takes the ‘‘necessary steps to remedy this stranglehold on contact lens competition’’). VerDate Sep<11>2014 20:17 Aug 14, 2020 Jkt 250001 Congress passed the Fairness to Contact Lens Consumers Act in 2003,21 and, in 2004, the Commission issued the Contact Lens Rule,22 implementing the Act. As specified in the Act, the Rule imposes requirements on both sellers and prescribers of contact lenses. Because the use of contact lenses involves significant health issues 23 and Congress recognized that consumers may be harmed by contact lenses purchased with an expired, inaccurate, or otherwise invalid prescription,24 the Act requires that contact lenses be sold only to patients with valid prescriptions, which they receive after contact lens fittings by a prescriber. The Act and the Rule only allow sales of contact lenses when a patient presents a seller with a copy of the prescription or the seller has verified the patient’s prescription with the prescriber.25 Sellers also are prohibited from altering a contact lens prescription.26 The Act and the Rule further impose obligations on prescribers. First and foremost, prescribers are required to release a copy of the prescription to the patient promptly upon completion of the contact lens fitting, ‘‘[w]hether or not requested by the patient.’’ 27 Prescribers also are prohibited from requiring: (1) The purchase of contact lenses as a condition of either prescription release or verification, (2) a separate payment for prescription release or verification, and (3) that the patient sign a waiver as a condition of prescription release or verification.28 Additionally, prescribers are required to provide or verify a contact lens prescription when ‘‘directed by any person designated to act on behalf of the patient.’’ 29 Such verification occurs when the seller provides the prescriber with a consumer’s prescription information and: (1) The prescriber confirms that the prescription is 21 15 U.S.C. 7601–7610. The FCLCA passed with a vote of 406 in favor and 12 opposed in the House, and unanimous consent in the Senate. 22 Contact Lens Rule, 69 FR 40482 (July 2, 2004) (codified at 16 CFR pt. 315). Pursuant to its congressional mandate, the FTC also issued a study of competition in the contact lens industry in 2005. See 2005 Contact Lens Report, supra note 14. 23 See, e.g., FTC, ‘‘Possible Barriers to ECommerce: Contact Lenses, A Report from the Staff of the Federal Trade Commission’’ 8–9 (2004), https://www.ftc.gov/sites/default/files/documents/ advocacy_documents/possible-anticompetitivebarriers-e-commerce-contact-lenses-report-staff-ftc/ 040329clreportfinal.pdf. 24 Contact Lens Rule, 69 FR 40482. 25 16 CFR 315.5(a). 26 16 CFR 315.5(e). 27 15 U.S.C. 7601(a)(1); 16 CFR 315.3(a)(1). 28 15 U.S.C. 7601(b)(1)–(3); 16 CFR 315.3(b)(1)– (3). 29 15 U.S.C. 7601(a)(2); 16 CFR 315.3(a)(2). PO 00000 Frm 00004 Fmt 4701 Sfmt 4700 accurate, by phone, facsimile, or electronic mail; (2) the prescriber informs the seller that the prescription is inaccurate and provides the correct prescription; or (3) the prescriber does not communicate with the seller within eight business hours of the seller’s request for verification (‘‘passive verification’’).30 The eight-businesshour 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. One outcome of passive verification, however, is that, if a prescriber does not respond to a verification request containing inaccurate information or for an invalid prescription within eight business hours, the prescription is deemed verified; thus, passive verification allows for the possibility that patients can be sold lenses for which they do not have a valid prescription. Congress, when considering the FCLCA, was aware that a passive-verification regime could, in some instances, allow sellers to sell and ship contact lenses based on an invalid or inaccurate prescription, and that this could potentially lead to health risks.31 Congress opted for a passive-verification regime despite this concern in order ‘‘to ensure that consumers are not caught in the competitive tug-of-war between doctors and third party sellers for the sale of contact lenses.’’ 32 It was also envisioned that prescribers would remain diligent in ensuring that patients did not receive lenses for which they had not been prescribed, since it is in both prescribers’ self-interest and the health and safety interests of their patients to prevent this from occurring.33 In this manner, the passiveverification system was perceived, to a certain extent, to be self-enforcing, as prescribers would have both a financial interest and an ethical duty to police invalid, incorrect, or expired prescriptions.34 30 15 U.S.C. 7603(d)(1)–(3); 16 CFR 315.5. e.g., FCLCA Subcomm. Hearing, supra note 17 (statements of Howard Beales, Federal Trade Commission); id. (statements of J. Pat Cummings, American Optometric Association) (‘‘And the problem with passive verification is that people will get contact lenses without a prescription.’’). 32 H.R. Rep. No. 108–318, at 5. 33 Contact Lens Rule, 69 FR at 40498. 34 FCLCA Subcomm. Hearing, supra note 17 (statements of Howard Beales, Federal Trade 31 See, E:\FR\FM\17AUR2.SGM 17AUR2 Federal Register / Vol. 85, No. 159 / Monday, August 17, 2020 / Rules and Regulations C. Initial Request for Comments in 2015 As part of its periodic review of its rules and guides, on September 3, 2015, the Commission solicited comments on the Contact Lens Rule, seeking input on: The economic impact of, and continuing need for, the Rule; the benefits of the Rule to consumers purchasing contact lenses; the burdens the Rule places on entities subject to its requirements; the impact the Rule has had on the flow of information to consumers; the degree of industry compliance with the Rule; the need for any modifications to increase its benefits or reduce its burdens or to account for changes in relevant technology; and any overlap or conflict with the Rule and other federal, state, or local laws or regulations.35 The comment period for this initial request closed on October 26, 2015. The Commission received approximately 660 comments from individuals and entities representing a wide range of viewpoints, including prescribing eyecare practitioners (ophthalmologists and optometrists), opticians and other eyewear industry members, sellers of contact lenses (both online and brickand-mortar), contact lens manufacturers, and consumers.36 D. Notice of Proposed Rulemaking in 2016 After a review of comments, surveys, other submitted information, and its own enforcement experience, the Commission determined that the overall weight of the evidence demonstrated a need to improve compliance with the Rule’s automatic prescription-release requirement, as well as a need to create a mechanism for monitoring and enforcing the Rule.37 To achieve this, the Commission issued a Notice of Proposed Rulemaking (‘‘NPRM’’) on December 7, 2016 that proposed to add a signed-acknowledgment requirement.38 The signedCommission) (stating that passive verification is in many respects self-enforcing). See also id. (statements of Jonathan Coon, 1–800 CONTACTS) (explaining to the Committee that from their experience with an existing passive verificationsystem in California, doctors have motivation to block invalid-prescription sales. ‘‘So they tell us if there is any problem with the prescription, if it’s expired, it’s invalid, whatever the problem is with the prescription. If they can tell us, you can believe they tell us absolutely every time.’’). 35 Contact Lens Rule Request for Comment (‘‘RFC’’), 80 FR 53272 (Sept. 3, 2015). 36 Comment figures are approximations because identical comments are sometimes submitted more than once. RFC comments are available at https:// www.ftc.gov/policy/public-comments/2015/09/ initiative-621. 37 Notice of Proposed Rulemaking, 81 FR 88526 (Dec. 7, 2016) [hereinafter NPRM]. 38 Id. The NPRM also proposed a technical amendment, to remove the words ‘‘private label’’ VerDate Sep<11>2014 20:17 Aug 14, 2020 Jkt 250001 acknowledgment requirement was to be triggered once the prescriber presented the prescription to the patient, and the acknowledgment form could be in either paper or electronic format. As proposed, the acknowledgment form was to be entitled ‘‘Patient Receipt of Contact Lens Prescription’’ (‘‘Signed Acknowledgment’’), and state, ‘‘My eye care professional provided me with a copy of my contact lens prescription at the completion of my contact lens fitting. I understand that I am free to purchase contact lenses from the seller of my choice.’’ Prescribers would be required to maintain copies of the acknowledgment forms in paper or electronically for not less than three years. The NPRM sought comment on this proposal as well as the following issues: The provision of additional copies of prescriptions, the amount of time for a prescriber to respond to such a request, the use of patient portals to release prescriptions, and potential modifications to address concerns about automated telephone verification calls. The sixty-day comment period for the Commission’s NPRM closed on January 30, 2017. In response to its NPRM, the Commission received over 4,000 additional comments, many from prescribers concerned about the impact of the proposed signed-acknowledgment requirement.39 After considering these and other comments, the Commission determined that certain issues deserved additional discussion and examination. To obtain additional input and more fully consider commenter concerns, the Commission solicited additional comments 40 and held a public workshop on the Contact Lens Rule and the Evolving Contact Lens Marketplace on March 7, 2018. The workshop included six panels, covering issues relating to the overall contact lens marketplace, health and safety, competition, purchasing and verification, the proposed Signed Acknowledgment and consumer choice, and the future of contact lens prescribing and selling.41 In response to the Commission’s request and workshop, the Commission received approximately 3,400 additional from § 315.5(e) to conform the language of the Rule to that of the FCLCA. 39 NPRM comments available at https:// www.ftc.gov/policy/public-comments/2016/10/ initiative-677. 40 Public Workshop Examining Contact Lens Marketplace and Analyzing Proposed Changes to the Contact Lens Rule, 82 FR 57889 (Dec. 8, 2017). 41 Workshop transcripts available at https:// www.ftc.gov/news-events/events-calendar/2018/03/ contact-lens-rule-evolving-contact-lensmarketplace. PO 00000 Frm 00005 Fmt 4701 Sfmt 4700 50671 comments from a wide range of commenters, including numerous consumers and prescribers, as well as industry associations, state attorneys general, contact lens manufacturers, and contact lens sellers.42 E. Supplemental Notice of Proposed Rulemaking After reviewing the comments submitted in response to the public workshop and Notice of Proposed Rulemaking, the Commission issued a Supplemental Notice of Proposed Rulemaking (‘‘SNPRM’’) on May 28, 2019 that modified its previous proposal for a Signed Acknowledgment by instituting a more flexible Confirmation of Prescription Release provision.43 In addition, the SNPRM put forth new proposals to modify the Rule by: (a) Adding a definition of the term ‘‘provide to the patient a copy,’’ to allow the prescriber to provide the patient with a digital copy of the patient’s prescription in lieu of a paper copy; (b) providing forty business hours as the time period for which a prescriber must provide a prescription upon request to a person designated to act on behalf of the patient; (c) creating new message delivery and recordkeeping requirements for sellers using automated telephone verification messages; (d) amending and clarifying the prohibition on seller alteration of prescriptions; and (e) requiring that sellers provide a method that would allow patients to present their prescriptions to the seller. The Commission requested comment on its SNPRM proposal; the sixty-day comment period closed on July 29, 2019. In response to its SNPRM, the Commission received approximately 200 unique comments (and approximately 900 comments total) from a variety of stakeholders, including prescribers and prescriber-trade organizations, contact lens manufacturers, contact lens sellers, legislators, state attorneys general, economic think tanks and academics, consumer-interest organizations, and individual consumers themselves.44 The majority of commenters opined on the Confirmation of Prescription Release proposal, and many also commented on the Commission’s new proposals regarding prescription verification and alteration. This Statement of Basis and Purpose for the Final Rule summarizes 42 Workshop comments available at https:// www.ftc.gov/policy/public-comments/2018/01/ initiative-733. 43 Supplemental Notice of Proposed Rulemaking, 84 FR 24664 (May 28, 2019) [hereinafter SNPRM]. 44 SNPRM comments available at https:// www.regulations.gov/docket?D=FTC-2019-0041. E:\FR\FM\17AUR2.SGM 17AUR2 50672 Federal Register / Vol. 85, No. 159 / Monday, August 17, 2020 / Rules and Regulations the relevant comments received in response to the proposals set forth in the NPRM and SNPRM and explains the Commission’s analyses and decisions to amend or not amend the Rule. II. Final Rule Pertaining to Confirmation of Prescription Release The following sections discuss the Confirmation of Prescription Release proposal in the SNPRM, the comments to the SNPRM in support of and opposition to the Confirmation of Prescription Release proposal, the Commission’s analysis and conclusions, and the amendments to the Final Rule instituting a Confirmation of Prescription Release. Because many of the comments focused on the Commission’s basis for its SNPRM proposal, and whether that basis is supported by evidence in the record, the Commission also reiterates the basis set forth in the SNPRM and discusses related comments and subsequent determinations in this Statement of Basis and Purpose for the final amended Contact Lens Rule. The Commission’s authority to modify the Rule and implement a Confirmation of Prescription Release requirement derives from the FCLCA, which directed the FTC to prescribe implementing rules, and authorized the Commission to investigate and enforce the Act in the same manner, by the same means, and with the same jurisdictional powers and duties as a trade regulation rule under the Federal Trade Commission Act.45 Congress clearly intended that prescriptions be provided to all consumers at the completion of the contact lens fitting process.46 Survey evidence, the record of these proceedings, and the Commission’s own experience with the Rule indicate that is not occurring at anywhere near the rate Congress intended. Consequently, the Commission believes that imposing a Confirmation of Prescription Receipt requirement is critical to effectuate congressional intent to the fullest extent.47 In a comment to the NPRM, the American Optometric Association (‘‘AOA’’) contended that the Commission does not have the authority to add requirements to the Rule that are not found in the text of the FCLCA.48 45 15 U.S.C. 7601–7610 (Pub. L. 108–164). U.S.C. 7601; see also H.R. Rep. No. 108–318, at 4 (2003) (‘‘The practice of optometrists withholding the prescription has limited the consumer’s ability to shop for the best price and has [adversely] impacted competition.’’). 47 See H.R. Rep. No. 108–318, at 6 (2003) (‘‘The goal of this legislation is to allow consumer access to their contact lens prescriptions. . . .’’). 48 American Optometric Association (NPRM Comment #3830). 46 15 VerDate Sep<11>2014 20:17 Aug 14, 2020 Jkt 250001 According to the AOA, because the FCLCA is a statute that ‘‘carefully enumerates specific substantive requirements but not others’’—as opposed to a general grant of authority—the agency charged with administering the FCLCA ‘‘should not add additional requirements that Congress did not enact.’’ 49 The Commission does not agree with this interpretation. As noted above, the FCLCA contains an express delegation of authority to the FTC to craft rules to carry out the Act.50 Pursuant to this delegation, the FTC has broad rulemaking authority to implement requirements for the purpose of preventing unfair or deceptive acts or practices in or affecting commerce, including failure to provide patients with copies of their prescriptions.51 The proposed modification requiring that patients sign a Confirmation of Prescription Release is consistent with the statute and falls well within the Commission’s statutory jurisdiction under the FCLCA.52 A. Proposed Modifications in the SNPRM The SNPRM proposed to amend the NPRM’s signed-acknowledgment proposal by replacing that requirement with a shorter and more flexible Confirmation of Prescription Release provision. Rather than requiring, as proposed in the NPRM, that prescribers request that each contact lens patient sign a form with mandatory language 49 Id. 50 15 U.S.C. 7607. id. (directing the FTC to ‘‘prescribe rules pursuant to section 57a of this title to carry out [the FCLCA]’’); 15 U.S.C. 57a(a)(1)(B) (authorizing the FTC to prescribe ‘‘rules which define with specificity acts or practices which are unfair or deceptive acts or practices in or affecting commerce,’’ including rules that contain ‘‘requirements prescribed for the purpose of preventing such acts or practices’’); 15 U.S.C. 7601(a) (mandating that when a prescriber completes a contact lens fitting, the prescriber ‘‘whether or not requested by the patient, shall provide to the patient a copy of the contact lens prescription’’). 52 15 U.S.C. 7601(a), 7607. AOA’s stance that a statute’s enumeration of some requirements but not others necessarily signifies that Congress deliberately excluded the non-included requirements is also incorrect in the rulemaking context. It is well established that the canon of statutory interpretation expressio unius est exclusion alterius (‘‘the expression of one is the exclusion of others’’) does not have force in the administrative setting, where Congress is presumed to have left to reasonable agency discretion questions that it has not directly resolved. See Adirondack Med. Ctr. v. Sebelius, 740 F.3d 692, 697 (D.C. Cir. 2014); St. Marks Place Hous. Co. v. U.S. Dep’t of Hous. & Urban Dev., 610 F.3d 75 (D.C. Cir. 2010); AFL–CIO v. Chao, 409 F. 3d 377 (D.C. Cir. 2005); Mobile Comm’cns Corp. of Am. v. FCC, 77 F.3d 1399, 1404–05 (D.C. Cir. 1996); see also Farrell v. Pompeo, No. 17–490, 2019 U.S. Dist. LEXIS 205831, *25–27 (D.C. Cir. Nov. 27, 2019). 51 See PO 00000 Frm 00006 Fmt 4701 Sfmt 4700 acknowledging receipt of the prescription and an understanding of the right to purchase lenses elsewhere,53 in the SNPRM the Commission proposed requiring prescribers instead to do one of the following: (A) Request that the patient acknowledge receipt of the contact lens prescription by signing a separate statement confirming receipt of the contact lens prescription; (B) Request that the patient sign a prescriber-retained copy of a contact lens prescription that contains a statement confirming receipt of the contact lens prescription; (C) Request that the patient sign a prescriber-retained copy of the sales receipt for the examination that contains a statement confirming receipt of the contact lens prescription; or (D) If a digital copy of the prescription was provided to the patient (via methods including an online portal, electronic mail, or text message), retain evidence that such prescription was sent, received, or made accessible, downloadable, and printable.54 The Commission’s proposal provided sample language for confirmation options (A), (B), and (C),55 but also allowed prescribers to craft their own wording of the signed confirmation for these options if they so desired. Unlike the NPRM’s signed-acknowledgment proposal, which applied to all prescribers, the SNPRM’s Confirmation of Prescription Release proposal only applied to prescribers with a financial interest in the sale of contact lenses.56 B. Basis for SNPRM Confirmation of Prescription Release Proposal The Commission explained in the SNPRM that it based its Confirmation of Prescription Release proposal on a variety of evidence, including: Multiple consumer surveys consistently showing prescriber non-compliance with, and lack of consumer awareness of, the Rule’s prescription-release requirement; numerous accounts of prescribers’ failure to release prescriptions; the 53 NPRM, 81 FR at 88559 (The form would have stated: ‘‘My eye care professional provided me with a copy of my contact lens prescription at the completion of my contact lens fitting. I understand I am free to purchase contact lenses from the seller of my choice.’’). 54 SNPRM, 84 FR at 24667. 55 The Commission said it had no wish to burden prescribers with the task of formulating adequate confirmation language if they would prefer to use a sentence from the language the Commission previously proposed: ‘‘My eye care professional provided me with a copy of my contact lens prescription at the completion of my contact lens fitting.’’ The Commission said use of such language would satisfy the proposed requirement. SNPRM, 84 FR at 24683. 56 Id. E:\FR\FM\17AUR2.SGM 17AUR2 Federal Register / Vol. 85, No. 159 / Monday, August 17, 2020 / Rules and Regulations persistently high number of verifications, many of which would be unnecessary were consumers in possession of their prescriptions; the regulatory structure of the contact lens market, which requires a consumer to obtain lenses pursuant to a prescription while permitting prescribers to sell what they prescribe; and the lack of credible empirical evidence rebutting or contradicting the evidence that prescribers are not automatically releasing prescriptions, and that consumers are not fully aware of their rights.57 The Commission also noted that the potential benefit of increasing the number of patients in possession of their prescriptions is substantial for consumers, sellers, and prescribers: Namely, increased flexibility and choice for consumers; a reduced verification burden for prescribers and sellers; and a reduced likelihood of errors associated with incorrect, invalid, and expired prescriptions and, consequently, improved patient safety.58 The Commission further explained that it faces serious challenges enforcing the Rule and monitoring compliance because it often comes down to the word of the patient against the word of the prescriber, which might require the Commission to issue administrative subpoenas and conduct investigational hearings—which could be resourceintensive for the Commission and costly, time-consuming, and disruptive for prescribers—in order to investigate each potential violation.59 The Commission thus concluded that some form of retained documentation is necessary to improve its ability to enforce and monitor prescriber compliance with the prescriptionrelease requirements.60 The Commission also determined that signage—an alternative suggested by NPRM commenters—was not an appropriate or effective means of ensuring that patients receive their prescriptions as required by law.61 Lastly, the Commission determined that despite commenter concerns, the burden to obtain signatures and retain records would be relatively minimal and outweighed by the benefits.62 The Commission, however, was receptive to an NPRM commenter recommendation to modify the signed-acknowledgment proposal in order to further reduce the burden and allow for greater 57 Id. 58 Id. at 24680–81. at 24681. 59 Id. 60 Id. 61 Id. 62 Id. at 24681–82. VerDate Sep<11>2014 20:17 Aug 14, 2020 Jkt 250001 flexibility,63 and thus the SNPRM’s Confirmation of Prescription Release proposal included three new options for prescribers to obtain or establish proof of prescription release and exempted prescribers who lacked a financial interest in the sale of contact lenses.64 According to the Commission, the Confirmation of Prescription Release proposal retained most of the benefits of the NPRM’s signed-acknowledgment proposal, but would be less disruptive and burdensome for prescribers.65 C. Comments on the Confirmation of Prescription Release Proposal and the Basis for Such Proposal Commenter response to the Commission’s proposal in the SNPRM was varied. Some commenters applauded the proposed amendments as improvements to the prior signedacknowledgment proposal, and as a balanced response to competing interests of consumers, sellers, and prescribers.66 Some, for instance, praised the confirmation proposal as an attempt to increase consumer access to prescriptions while making it easier and more efficient for prescribers to adhere to the patient-acknowledgment requirement by allowing flexible methods for obtaining the patient’s signature.67 Other commenters, 63 The recommendation was submitted by the National Association of Optometrists and Opticians in its comments to the Contact Lens Workshop and the NPRM, see id. at 24680 (citing National Association of Optometrists and Opticians (WS Comment #3208)). 64 SNPRM, 84 FR at 24683. 65 Id. 66 R Street Institute (SNPRM Comment #15) (‘‘The Commission’s proposal is both reasonable and not overly burdensome.’’); Grimm (SNPRM Comment #36) (‘‘There is no doubt that the modified Contact Lens Rule should be embraced by prescribers, sellers, and consumers as an improvement to consumer products trade rules.’’); Americans for Tax Reform (SNPRM Comment #72) (‘‘These changes strike the correct balance between promoting the free market and protecting important consumer rights.’’); Lens.com (SNPRM Comment #85) (‘‘We believe you have struck the correct balance . . . .’’); Coalition for Contact Lens Consumer Choice (SNPRM Comment #89) (‘‘What the FTC is proposing is a common sense, minimally-burdensome rule that optometrists, ophthalmologists, and consumers alike can and should support.’’); Taxpayers Protection Alliance (SNPRM Comment #118) (‘‘Although we are often critical of government overreach and work hard to make government smaller, we believe that the FTC’s proposed Contact Lens Rule is a government rule that works for taxpayers and consumers and creates an open transparent contact lens market in the US where taxpayers have real choice and there is real competition in the marketplace.’’); Attorneys General of 27 States (SNPRM Comment #139) (‘‘We believe the proposed modifications in the SNPRM are reasonable modifications that balance the interests of consumers, eye care professionals, and the eye care industry.’’). 67 Anonymous (SNPRM Comment #63); Rawson (SNPRM Comment #68) (‘‘This proposed rule PO 00000 Frm 00007 Fmt 4701 Sfmt 4700 50673 however, asserted that the proposal watered down prescriber obligations and would thus be less effective than the NPRM’s signed-acknowledgment proposal in ensuring that consumers receive their prescriptions and are aware of their rights.68 And several commenters, primarily contact lens prescribers, stated that despite the increased flexibility, the Confirmation of Prescription Release proposal still created too much of a burden for prescribers, and they criticized the Commission’s approach and the evidence relied upon.69 1. Comments About the Need for the Confirmation of Prescription Release and Whether Prescribers Are Complying With the Rule’s Automatic Prescription Release Requirement a. Survey Evidence as Proof of NonCompliance Many of the SNPRM comments focused on the need for a Signed Acknowledgment or Confirmation of Prescription Release, and on whether evidence in the record supports the Commission’s determination that prescribers are not complying with the Rule’s prescription-release requirement. Several commenters, such as 1–800 CONTACTS, Consumer Action, and the Attorneys General of Twenty-Seven States, contended (as they did in comments responding to either the NPRM, the Contact Lens Workshop, or both) 70 that prescriber noncompliance remains a problem, and that millions of Americans are not receiving their prescriptions after a contact lens fitting.71 The Attorneys General of Twenty-Seven States, for instance, commented that consumers in their states continue to report that prescribers are failing to automatically provide patient prescriptions in writing.72 Likewise, the online seller 1–800 CONTACTS submitted a new survey of consumers, conducted for it by the allows prescribers the ability to model the rule to best fit their practice, but still give the consumers the protection and the knowledge they need.’’). 68 Consumer Reports (SNPRM Comment #133); 1– 800 CONTACTS (SNPRM Comment #135). 69 American Optometric Association (SNPRM Comment #96); Reeder (SNPRM Comment #55) (even signature on prescription or patient receipt is burdensome); Kegler (SNPRM Comment #99) (proposal will still place financial and administrative burdens on prescribers). 70 See 1–800 CONTACTS (NPRM Comment #3898); 1–800 CONTACTS (WS Comment #3207); Consumer Action (NPRM Comment #3721); Comments of the Attorneys General of 20 States (NPRM Comment #3804). 71 1–800 CONTACTS (SNPRM Comment #135); Attorneys General of 27 States (SNPRM Comment #139). 72 Attorneys General of 27 States (SNPRM Comment #139). E:\FR\FM\17AUR2.SGM 17AUR2 50674 Federal Register / Vol. 85, No. 159 / Monday, August 17, 2020 / Rules and Regulations polling firm Dynata (formerly known as Survey Sampling International), showing that prescriber compliance has not markedly improved, despite the attention focused on automaticprescription-release obligations since the FTC initiated its rule review in 2015.73 According to the new survey, nearly 49% of contact lens patients report that their prescribers did not automatically give them their prescription after their eye examination.74 Of those who did not receive their prescription automatically, a little more than half received it after requesting it, while 43% never received their prescription.75 Extrapolating this data to the general population of 45 million U.S. contact lens users 76 would mean there are approximately 22 million annual violations of the Contact Lens Rule, and that each year more than 9.4 million contact lens users do not receive their prescriptions.77 The 2019 consumer survey data is consistent with several prior surveys of contact lens users conducted in 2014, 2015, 2016, and 2017 on behalf of 1–800 CONTACTS and the consumer rights organization Consumer Action,78 as well as a survey of eyeglass wearers (who, per the FTC’s Eyeglass Rule, are also to automatically receive their prescriptions following a refractive eye exam) conducted on behalf of Warby Parker in 2015.79 Some commenters also pointed to previously-submitted evidence indicating that many U.S. contact lens users are still unaware of their right to automatically receive their prescriptions and take them elsewhere for filling.80 73 1–800 CONTACTS (SNPRM Comment #135). CONTACTS (SNPRM Comment #135, Ex. B). The poll was of 1011 contact lens users between the ages of 18–49, and the relevant questions asked were ‘‘At your last eye exam, did the eye care provider provide you with a copy of your contact lens prescription?’’ and ‘‘In order to obtain a copy of your prescription, did you have to ask your eye care provider for it?’’ Approximately 41% said they received it automatically, 49% said they did not, and 10% did not recall or were unsure. 75 Id. 76 Centers for Disease Control, Healthy Contact Lens Wear and Care, Fast Facts, https:// www.cdc.gov/contactlenses/fast-facts.html. 77 This is based on the estimate—long used to calculate the financial burden of the Rule for Paperwork Reduction Act purposes—that consumers obtain one contact lens prescription per year. See, e.g., SNPRM, 84 FR at 24692; Paperwork Reduction Act Proposed Collection; Comment Request, 81 FR at 31940; Paperwork Reduction Act Proposed Collection; Comment Request, 78 FR at 9392. 78 SNPRM, 84 FR at 24671–72. 79 NPRM, 81 FR at 88531. 80 Coalition for Contact Lens Consumer Choice (SNPRM Comment #89); Consumer Action (SNPRM Comment #101); 1–800 CONTACTS (SNPRM Comment #135). 74 1–800 VerDate Sep<11>2014 20:17 Aug 14, 2020 Jkt 250001 While commenters to the SNPRM did not submit updated polling data on consumer awareness, several cited previously-submitted data indicating that between 46–60% of consumers are unaware that under federal law a prescriber is required to provide the patient with a copy of their prescription after they complete their contact lens exam.81 Another commenter, the National Hispanic Medical Association (‘‘NHMA’’), noted that polls show that Hispanic patients are disproportionately impacted by prescribers’ failure to release prescriptions, and are less likely to understand their rights under the FCLCA.82 According to the NHMA, ‘‘Our community continually has been victimized and denied their prescriptions by prescribers and doctors at a higher rate than most other Americans. We strongly believe that more must be done to ensure patients are informed of their rights and given copies of their prescriptions.’’ 83 A number of SNPRM commenters, however, were critical of the polling data provided to, and relied upon by, the Commission. The American Academy of Ophthalmology (‘‘AAO’’) asserted that data showing prescriber non-compliance consisted of ‘‘industrysponsored surveys’’ and was therefore unreliable.84 AAO added that it is ‘‘unaware of issues’’ with prescribers failing to release prescriptions, and stated its members ‘‘know that ophthalmology has a strong record of compliance.’’ 85 Likewise, the American Society of Cataract and Refractive Surgery (‘‘ASCRS’’) asserted that there is no independent third-party evidence suggesting physicians are not providing prescriptions to patients, and that the Commission is basing compliance on ‘‘survey polls sponsored by stakeholders with financial interest in the sale of contact lenses.’’ 86 According to the ASCRS, before amending the Rule, the Commission should obtain data from a disinterested organization.87 The AOA was highly critical of polling data supplied by 1–800 81 Consumer Action (SNPRM Comment #101) (‘‘Our survey showed a fundamental lack of understanding by consumers about their automatic right to receive a copy of their prescription’’); 1–800 CONTACTS (SNPRM Comment #135); see SNPRM 84 FR at 24672 (discussing polls of consumer knowledge of their rights). 82 National Hispanic Medical Association (SNPRM Comment #146). 83 Id. 84 American Academy of Ophthalmology (SNPRM Comment #136). 85 Id. 86 American Society of Cataract and Refractive Surgery (SNPRM Comment #127). 87 Id. PO 00000 Frm 00008 Fmt 4701 Sfmt 4700 CONTACTS, and stated that since the online seller, in its advertising, encouraged consumers to ‘‘skip the trip to the optometrist’’ and instead renew prescriptions online (via telemedicine), the online seller has a demonstrated bias against optometrists that taints the material it submits.88 The AOA further stated that some consumer survey findings may be misleading because it is ‘‘very typical’’ for consumers to request their prescriptions before their contact lens fitting is complete, and thus before prescribers are obligated—under the Rule and the FCLCA—to release them to consumers.89 Therefore, some consumers might indicate on a survey that they were required to ask for their prescriptions when, in fact, they asked before they were entitled to receive them. As support for this contention, AOA stated that it surveyed some of its members and found that 91.7% ‘‘indicated that there are times when a patient will ask for his/her prescription prior to the finalization of the contact lens fitting.’’ 90 The Commission recognizes that some consumers may think they had to ask for their prescriptions when, in fact, they would have received them when their fittings were complete. However, the AOA did not suggest, nor provide any data or information, as to how often this may occur, and thus how much it might skew the results of consumer surveys. As a result, the Commission is unable to estimate what portion of the 49% who stated they did not automatically receive their prescription—in the most recent survey—gave that response because they misunderstood when they were entitled to receive their prescription.91 88 American Optometric Association (SNPRM Comment #96). 89 Id. 90 Id. The AOA reported this result in its comment, and it stated that its survey was of 629 prescribers, but did not provide the FTC with the underlying survey data, information about the manner in which the survey was conducted, how the 629 prescribers were selected, or the specific questions that were asked. 91 The Commission also notes that eyeglass patients are entitled to their prescriptions immediately following their exam (since they do not have to wait for a fitting), and thus would rarely ask for their prescriptions before they are entitled to them, and yet two 2015 surveys of eyeglass wearers—one on behalf of Warby Parker, the other for 1–800 CONTACTS—found that 47% and 66%, respectively, of eyeglass patients who visited an optometrist reported that they were not automatically provided a prescription at the end of their exam. NPRM, 81 FR at 88531 (citing Warby Parker (Comment #813 on the Ophthalmic Practice Rule), available at https://www.ftc.gov/policy/ public-comments/initiative-624); 1–800 CONTACTS (RFC Comment #568, Ex. B). This would seem to indicate that most consumer reports that they did not receive their prescriptions are not E:\FR\FM\17AUR2.SGM 17AUR2 Federal Register / Vol. 85, No. 159 / Monday, August 17, 2020 / Rules and Regulations Moreover, even if the Commission were to disregard evidence of consumers who obtained their prescriptions only after asking for them, five consumer surveys from 2015 to 2019 (six if the Warby Parker eyeglass wearers’ survey is included) indicate that between 21%–36% of consumers— approximately 9.5 to 16.2 million contact lens users each year—did not receive their prescriptions at all after getting fitted for their lenses.92 This level of non-compliance on its own supports the Commission’s recommendation. As for commenter criticism that consumer surveys were submitted by interested parties, the Commission reiterates what it stated in the SNPRM: while cognizant of the interests of submitting parties, the Commission, whenever possible, examines the underlying survey data and methodology to gauge a survey’s usefulness and considers factors such as how many people are queried, how the questions are phrased, and whether the surveys are conducted in-house or by independent and established third-party based on a misunderstanding of when they are supposed to receive them. 92 This approximation is based on the current estimate that there are 45 million contact lens users in the United States. Centers for Disease Control, Healthy Contact Lens Wear and Care, Fast Facts, https://www.cdc.gov/contactlenses/fast-facts.html. The results from the individual surveys are as follows: (1) June 2019 survey by Dynata on behalf of 1–800 CONTACTS of 1011 contact lens users found that 21% said they never received their prescriptions (1–800 CONTACTS (SNPRM Comment #135)); (2) January 2017 survey by Caravan ORC International on behalf of Consumer Action of 2018 adults found that 31% of contact lens users said that at their last eye exam, their doctor did not provide them with a paper copy of their prescription (Consumer Action (NPRM Comment #3721)); (3) December 2016 survey of 1000 contact lens users by Survey Sampling International (‘‘SSI’’) on behalf of 1–800 CONTACTS found that 24% of consumer respondents said they did not receive their prescription (1–800 CONTACTS (NPRM Comment #3898)); (4) October 2015 SSI survey of 500 contact lens users and 303 eyeglass users on behalf of 1– 800 CONTACTS found that 36% of contact lens users and 39% of eyeglass wearers said they did not receive their prescription (1–800 CONTACTS (RFC Comment #568, Ex. B)); (5) May 2015 SSI survey of 2000 contact lens wearers found that 34% said they did not receive their prescription (1–800 CONTACTS (RFC Comment #568, Ex. C)); and (6)November 2014 SSI survey of 2000 contact lens wearers found that 34% said they did not receive their prescription (1–800 CONTACTS (RFC Comment #568, Ex. C)). As noted in the SNPRM, the manner in which a few of the questions were phrased in the 2014 and 2015 surveys raised some Commission concerns, since some questions were leading, lacked an ‘‘I don’t know’’ response option, and used a term—‘‘hard copy’’—which not all consumers may understand. The more recent surveys represented an improvement because they included an option for respondents to acknowledge that they do not recall whether they received their prescriptions, and used the term ‘‘paper copy’’ rather than ‘‘hard copy.’’ SNPRM, 84 FR at 24672. VerDate Sep<11>2014 20:17 Aug 14, 2020 Jkt 250001 polling firms.93 The Commission also recognizes that all surveys may have methodological limitations, and, in this instance, does not treat any one survey as controlling. The Commission, however, also recognizes that multiple surveys conducted by different sources at different times with similar results bolster the credibility of each individual survey, as does the fact that in this matter, one survey, submitted by Consumer Action and conducted by the third-party polling firm Caravan ORC International, is not from a party with a direct financial stake in the contact lens industry.94 The Commission also notes that despite multiple opportunities and requests for comment since 2015, the Commission has yet to find or receive any reliable consumer-survey data rebutting or contradicting the submitted survey findings, or establishing that consumers consistently receive their prescriptions. The only empirical evidence of prescriber compliance in the record is a survey of fifty-seven ‘‘high volume’’ prescribers submitted by AOA in response to the NPRM, which found that 93% responded ‘‘yes’’ when asked, ‘‘Do you follow Federal law and provide patients with a copy of their contact lens prescription upon completion of a contact lens fitting?’’ 95 For the reasons stated in the SNPRM,96 the Commission does not accord this survey significant weight, and finds that it does not counter the multiple consumer surveys conducted over a number of years showing prescriber non-compliance. The Commission accords the empirical data from multiple consumer surveys significant weight in establishing that a substantial percentage of prescribers are not complying with the automatic93 SNPRM, 84 FR at 24672. AOA had previously noted, in response to the NPRM, that Consumer Action has received corporate financial support from, among others, 1– 800 CONTACTS. Id. Consumer Action, however, is a long-established non-profit consumer advocacy organization without a financial interest in the outcome of this Rule review. 95 SNPRM, 84 FR at 24672; American Optometric Association (WS Comment #3303, Ex. B). This survey appears to have been conducted by the AOA itself rather than an outside polling firm. It is not clear from the AOA’s submission how the fiftyseven optometrists were selected for the survey, what it means to be a ‘‘high volume’’ optometrist, or why high-volume optometrists were chosen. 96 SNPRM, 84 FR at 24673 (noting concerns about the small sample size, lack of detail as to how prescriber respondents were recruited, and that the way the question is phrased allows prescribers to truthfully answer that they provide patients with a copy of their prescription even if they do not do so for every patient, and even if they only do so when the patient requests one). 94 The PO 00000 Frm 00009 Fmt 4701 Sfmt 4700 50675 prescription-release provision of the Rule. Apart from the empirical data discussed above, none of the commenters submitted new evidence relating to prescriber compliance. Many individual prescribers, however, continue to comment that they always comply with the requirement, as do all the prescribers they know, and therefore they believe that the Commission is looking to solve a non-existent problem.97 Some prescribers also reiterated that, in their experience, consumers are well aware that they can buy lenses elsewhere so there is no need to educate them further about their rights.98 And a few prescribers opined that the requirement was a ‘‘waste of time’’ because, in their experience, consumers would rather not have a copy of their prescription and know that they can request a copy whenever they want.99 The Commission has considered these comments but does not believe they establish that prescribers, on the whole, are complying with the automaticrelease requirement, or that consumers are fully aware of their prescriptionportability rights. Any prescriber may indeed comply with the Rule but cannot speak for other eye care providers in the United States, nor for contact lens consumers.100 In addition, several previous comments from prescribers and prescriber organizations who assert that they comply with the Rule actually revealed that many prescribers do not fully understand or comply with the Rule’s requirement that prescriptions be provided ‘‘whether or not requested by the patient.’’ 101 The Commission does not accord any weight to the comments that consumers do not want their prescriptions. As 97 See, e.g., Abert (SNPRM Comment #20); Hyndman (SNPRM Comment #21) (‘‘every OD I know follows’’ the FCLCA requirements); Fair (SNPRM Comment #26) (‘‘I have ALWAYS and will continue to comply fully with the prescription release requirements of the 2003 Fairness to Contact Lens Consumers Act.’’); Hughes (SNPRM Comment #113) (most optometrists comply); Ridder (SNPRM Comment #720) (every patient gets their prescription whether they order or ask for it or not). 98 Abert (SNPRM Comment #20); Jones (SNPRM Comment #48). 99 Sikes (SNPRM Comment #114); Morey (SNPRM Comment #142). 100 By one estimate, there are approximately 43,000 optometrists and 16,700 ophthalmologists in the U.S. FTC, The Contact Lens Rule and the Evolving Contact Lens Marketplace, Panel I: Overview of the Contact Lens Marketplace Tr. at 6 (Mar. 7, 2018), https://www.ftc.gov/system/files/ documents/public_events/1285493/panel_i_ overview_of_the_contact_lens_marketplace.pdf [hereinafter CLR Panel I Tr.]. 101 See SNPRM, 84 FR at 24673–74, discussing how a number of prescribers commented that they always offer prescriptions to consumers, or provide them on request. E:\FR\FM\17AUR2.SGM 17AUR2 50676 Federal Register / Vol. 85, No. 159 / Monday, August 17, 2020 / Rules and Regulations evidenced by the numerous NPRM comments from consumers urging the Commission to take action to ensure they are given their prescriptions, it cannot be doubted that many consumers have a compelling desire to have them.102 And more importantly, Congress made the determination that prescribers must provide patients with their prescriptions automatically, ‘‘whether or not requested by the patient.’’ 103 b. Lack of Consumer Complaints as Evidence of Compliance Some commenters reiterated the argument—raised and discussed in some detail in the SNPRM 104—that the lack of consumer complaints to the FTC about prescriber non-compliance is evidence that prescribers are releasing prescriptions as required.105 In the SNPRM, the Commission explained that it did not equate the lack of complaints with compliance because based on its experience, the vast majority of injured or impacted consumers do not register complaints with the government and, for various reasons, even fewer are likely to file a formal complaint about a prescriber’s failure to release their prescription.106 The Commission also noted that more than fifty consumers submitted comments to the NPRM recounting personal stories of prescribers withholding their prescriptions, yet none of these commenters had previously registered complaints with the FTC.107 In response, the AOA commented that if complaints to the FTC are not a good bellwether of prescriber compliance because consumers are unlikely to file formal complaints, the FTC should simplify and improve its complaintreporting system.108 The AOA deemed it unfair for the Commission to rely on 102 See, e.g., Boue (NPRM Comment #1806); Collins (NPRM Comment #1811); Hamilton (NPRM Comment #1835); Acton (NPRM Comment #2070); Dunbar (NPRM Comment #2652); Capuano (NPRM Comment #2722); Muckley (NPRM Comment #2768); Taravella (NPRM Comment #2892); Martinez (NPRM Comment #2894); Ballou (NPRM Comment #3331). See also SNPRM, 84 FR at 24671 (recounting comments from dozens of consumers complaining that they were denied their prescriptions). 103 FCLCA, 15 U.S.C. 7601(a)(1). 104 SNPRM, 84 FR at 24674–75. 105 Letter from Sens. Jack Reed and Sheldon Whitehouse (SNPRM Comment #6); Mass Mail Campaign (SNPRM Comment #25); Hanian (SNPRM Comment #27); Letter from 20 U.S. Senators (SNPRM Comment #38); Letter from Sen. Lisa Murkowski (SNPRM Comment #49); Levinson (SNPRM Comment #73); Cinalli (SNPRM Comment #93). 106 SNPRM, 84 FR at 24674–75. 107 Id. at 24675. 108 American Optometric Association (SNPRM Comment #96). VerDate Sep<11>2014 20:17 Aug 14, 2020 Jkt 250001 consumer survey data as evidence of prescribers’ failure to release prescriptions, but not rely on the absence of consumer complaints as evidence that prescribers are automatically providing prescriptions.109 The AOA stated the Commission should make an effort to make consumer complaint data—or lack thereof—more representative by providing a dedicated FCLCA complaint line for contact-lens-related issues.110 At the same time, however, the AOA stated that since ‘‘it is very typical’’ for patients to ask for their prescription before their contact lens fitting is complete, consumer complaints cannot necessarily be viewed as accurate indications of non-compliance.111 The Commission does not find these arguments persuasive. As noted in the SNPRM, the Commission has gleaned, through its extensive experience with consumer complaints and deceptive practices, that the vast majority of injured or impacted consumers do not file complaints with the government.112 And with the exception of the Telemarketing Sales Rule (often referred to as ‘‘Do Not Call’’), consumer complaints about FTC rule violations are rarer still, perhaps because they require that consumers know what an 109 Id. 110 Id. 111 Id. 112 SNPRM, 84 FR at 24675. Consumer reticence to complain, particularly to a government entity, is well documented. As one example, an FTC survey revealed that in 2017 there were an estimated 61.8 million incidents of fraud in the United States with approximately 40 million individual victims and average losses of $100 or more, yet the FTC received just 1.2 million complaints of fraud from consumers, approximately 1.9% of all incidents. Keith B. Anderson, FTC, ‘‘Mass Market Consumer Fraud in the United States, A 2017 Update,’’ 24, 56 (Oct. 2019); FTC, ‘‘Consumer Sentinel Network Data Book 2017,’’ Number of Reports by Type, https:// www.ftc.gov/site-information/open-government/ data-sets#csn. It is likely these figures actually overstate the percentage of frauds reported to the FTC, since the FTC’s fraud surveys are limited to specific types of fraud, while there is no such limitation on complaints of fraud from consumers. See also Keith B. Anderson, FTC, ‘‘Consumer Fraud in the United States: An FTC Survey’’ 80 (2004), http://www.ftc.gov/reports/consumer-fraud-unitedstates-ftc-survey, (indicating that only 8.4% of U.S. fraud victims complained to an official source, with only 1.4% complaining to the FTC); Marc A. Grainer et al., ‘‘Consumer Problems and Complaints: a National View,’’ 6 Advances in Consumer Res. 494 (1979) (noting that ‘‘only a small, vocal minority of consumers complain about the problems they experience,’’ and even fewer (less than 10% of complaints) complain to the government), http://acrwebsite.org/volumes/9603/ volumes/v06/NA-06; John Goodman & Steve Newman, ‘‘Understand Customer Behavior and Complaints,’’ Quality Progress, Jan. 2003, at 51 (finding that for problems that resulted in a relatively minor inconvenience or a small loss of money, only 3% of consumers complained), http:// web.ist.utl.pt/∼ist11038/CD_Casquilho/PRINT/ qp0103goodman.pdf. PO 00000 Frm 00010 Fmt 4701 Sfmt 4700 FTC rule specifies and how it has been violated.113 While the Commission continues to regard consumer complaints as valuable and informative, they often represent the tip of the iceberg. Furthermore, for reasons discussed in detail in the NPRM, the Commission does not believe its complaint-reporting system bears principal responsibility for the shortage of complaints about prescriber violations of the Contact Lens Rule.114 While the FTC does not have a dedicated complaint system solely for FCLCA violations, as sought by the AOA, the FTC Complaint Assistant is configured to capture and report all contact lens-related complaints, whether they originate from consumers, prescribers, sellers, or others.115 More to the point, multiple surveys have established that a high percentage of contact lens wearers (46–60%, according to submitted data) do not realize they are entitled to receive their prescription,116 and thus would not be aware that an incident about which they should complain had occurred. Many other consumers might be unaware of where to direct a complaint when they do not receive a prescription. Even consumers who are aware that they have a right to their prescription, and know they can file a complaint with the FTC, may be unlikely to file one if they ultimately receive their prescription after they have asked their provider for it. From the consumers’ perspective, they have resolved their problem and may perceive little benefit to themselves from filing a complaint with the government, even if the method for filing one was more streamlined or convenient. Consumers may also not want to risk antagonizing their providers or subjecting them to legal penalties. Thus, for evaluating Contact Lens Rule compliance, the Commission has considered the low rate of consumer complaints filed with the FTC’s Complaint Assistant, but remains convinced this is less probative of the 113 See generally, FTC, ‘‘Consumer Sentinel Network Data Book 2017,’’ Number of Reports by Type, https://www.ftc.gov/site-information/opengovernment/data-sets#csn. FTC, ‘‘Consumer Sentinel Network Data Book for January-December 2016’’ (2017), https://www.ftc.gov/system/files/ documents/reports/consumer-sentinel-networkdata-book-january-december-2016/csn_cy-2016_ data_book.pdf. 114 NPRM, 81 FR at 88554–55. 115 The Commission also notes that if, as the AOA asserts, some consumers would complain that they did not receive their prescriptions before they were, in fact, entitled to them, creating a dedicated system for FCLCA complaints would not make the number of complaints any more or less reflective of prescriber compliance. 116 SNPRM, 84 FR at 24675. E:\FR\FM\17AUR2.SGM 17AUR2 Federal Register / Vol. 85, No. 159 / Monday, August 17, 2020 / Rules and Regulations scope of the problem than other evidence.117 c. Number of Verifications as Evidence of Non-Compliance With the Automatic Prescription Release Requirement In the SNPRM, the Commission noted that it would accord the number of verifications less weight than it had in the NPRM as evidence of prescriber non-compliance out of a recognition that some consumers—even if in possession of their prescription—may find it easier to type in their specifications than present a prescription to the seller, and because some online contact lens sellers do not have a mechanism for consumers to present their prescriptions.118 In its comment to the SNPRM, the AOA contended that the high number of verifications should not be accorded any weight at all for those reasons. As additional support for this contention, the AOA cited internal prescriber complaint data showing that the percentage of prescriber complaints about ‘‘problematic verification calls’’ has increased from roughly 6% to 17% in the past four years; it attributed much of this increase to the emergence of an online seller that does not permit patient prescription presentation.119 According to the AOA, the increase in complaints about verification, and the high percentage of such complaints about the online seller, demonstrate that a ‘‘high volume of verification calls are occurring based on a prescription that was never written,’’ and therefore the number of verification calls is ‘‘simply not an appropriate measure for assessing contact lens prescription requirements and should be afforded no weight.’’ 120 The Commission is aware of the issues raised by the AOA, but still believes that the high number of verifications is an indication that many consumers are not receiving their prescriptions from their prescribers. While a few new online sellers do not permit prescription presentation, these sellers’ share of the overall contact lens sales is still quite small, even if their share of prescriber complaints, according to the AOA, is disproportionately large.121 Sellers with 117 Consumer surveys may also be more reliable since consumers questioned at random are less likely to have a personal interest in stating that they did not receive their prescription. 118 SNPRM, 84 FR at 24674. 119 American Optometric Association (SNPRM Comment #96). 120 Id. 121 1–800 CONTACTS accounts for approximately 10% of overall retail contact lens sales in the United States, and as much as 60–65% of online sales. The next closest online competitor has less than a quarter of the sales of 1–800 CONTACTS. VerDate Sep<11>2014 20:17 Aug 14, 2020 Jkt 250001 far greater sales, such as 1–800 CONTACTS and Walmart, actively encourage consumers to present their prescriptions, and 1–800 CONTACTS has even at times offered consumers discounts for doing so, because it is faster and less expensive than verification.122 Yet despite that encouragement, roughly 73% of overall sales by third-party sellers continues to occur via verification.123 Therefore, while the Commission will accord the high number of verifications less weight than it did in the NPRM, the Commission cannot dismiss its significance altogether as an indicator that consumers are not always provided their prescriptions, and will consider it as one of several factors in weighing the evidence of non-compliance in the record. The Commission also notes that even if the high number of verifications were disregarded altogether, the Commission’s overall assessment of prescriber compliance, and the need for Rule modifications, would not change. 2. Comments About the Need To Improve the Commission’s Ability To Monitor Compliance and Enforce the Rule Several commenters focused on the need to create an auditable record that would enable the Commission to monitor compliance and better enforce the automatic-release provision.124 One See Fed. Trade Comm’n, The Contact Lens Rule and the Evolving Contact Lens Marketplace, Panel IV: Examining the Verification Process Tr. at 17 (Mar. 7, 2018), https://www.ftc.gov/system/files/ documents/public_events/1285493/panel_iv_ examining_the_verification_process.pdf [hereinafter CLR Panel IV Tr.] (statement of Cindy Williams, 1– 800 CONTACTS General Counsel). Walmart accounts for between 6–10% of all U.S. contact lens sales. Complaint Counsel’s Post-Trial Brief and Exhibits, In the Matter of 1–800 CONTACTS, 5, (June 22, 2017), https://www.ftc.gov/system/files/ documents/cases/d09372ccfindingsoffact.pdf; Respondent 1–800 CONTACTS Proposed Findings of Fact and Conclusions of Law, In the Matter of 1–800 CONTACTS, 59 (June 22, 2017), https:// www.ftc.gov/system/files/documents/cases/ d09372respfindingsoffact.pdf. 122 National Association of Optometrists and Opticians (SNPRM Comment #129) (‘‘Because of the cost and time it takes to verify a prescription when the script is not available, typically an online seller encourages such uploading and this process aids in consumer satisfaction and quicker, more accurate service.’’); 1–800 CONTACTS (SNPRM Comment #135) (1–800 CONTACTS encourages its customers to upload their prescriptions). See also CLR Panel IV Tr., supra note 121, at 6–7 (statement of Jennifer Sommer of Walmart); id. at 6–7, 22 (statement of Cindy Williams of 1–800 CONTACTS). 123 Paperwork Reduction Act Proposed Collection, Comment Request, 84 FR at 32171. See also 1–800 CONTACTS (NPRM Comment #3898) (stating that 70% of online orders require verification). 124 Bosley (SNPRM Comment #58); Coalition for Contact Lens Consumer Choice (SNPRM Comment #89); National Hispanic Medical Association (SNPRM Comment #146). PO 00000 Frm 00011 Fmt 4701 Sfmt 4700 50677 commenter, the Coalition for Contact Lens Consumer Choice, stated the Confirmation of Prescription Release proposal gives prescribers more leeway to design a system of confirmation of prescription release, but ‘‘the important thing is that prescribers are still required to have patients affirmatively acknowledge release. . . . This is critical to increase enforcement of the law and to ensure that bad actors are identified quickly without inconveniencing those who are obeying the law.’’ 125 The commenter Citizen Outreach agreed, stating that the only way to ensure compliance with automatic release is by requiring consumers to sign a confirmation, and suggested that failing to require a consumer’s signed confirmation would be a loophole ‘‘large enough for ‘bad actors’ to drive a truckload of contact lenses through.’’ 126 Likewise, the Attorneys General of Twenty-Seven States commented that the proposed Confirmation of Prescription Release modifications ‘‘strengthen the Commission’s ability to verify compliance with the CLR [which] ensures more contact lens consumers have the necessary information to make informed decisions, spurring competition and consumer choice.’’ 127 Other commenters, however, felt that the FTC already has sufficient mechanisms to enforce the Contact Lens Rule, and should bring enforcement actions against so-called ‘‘outliers’’ who are violating the Rule, rather than imposing new requirements on all contact lens prescribers.128 Some suggested that the Confirmation of Prescription Release requirements should be imposed only on those found to be violating the prescription-release requirement.129 ‘‘By refocusing these ideas as penalties, rather than mandates,’’ according to AAO, ‘‘the FTC can ensure that they are not inflicting burdens on prescribers that have a record of compliance with the prescription release requirement in the 125 Coalition for Contact Lens Consumer Choice (SNPRM Comment #89). 126 Citizen Outreach (SNPRM Comment #78). 127 Attorneys General of 27 States (SNPRM Comment #139). 128 Mass Mail Campaign (SNPRM Comment #25); Ohio Optometric Association (SNPRM Comment #47); Hardy (SNPRM Comment #60) (‘‘Is it a fair idea to punish 100% of optometrists and ophthalmologists for the actions of a fraction of 1%’’); American Optometric Association (SNPRM Comment #96); American Academy of Ophthalmology (SNPRM Comment #136) (practices will have to comply with the new burdens even if they have complied with prescription-release for over a decade). 129 American Optometric Association (SNPRM Comment #96); American Academy of Ophthalmology (SNPRM Comment #136). E:\FR\FM\17AUR2.SGM 17AUR2 50678 Federal Register / Vol. 85, No. 159 / Monday, August 17, 2020 / Rules and Regulations CLR.’’ 130 AOA believes that the FTC already has sufficient authority and investigative tools at its disposal, and suggested the Commission could use its ability to issue administrative subpoenas to investigate prescribers who might be violating the Rule.131 One prescriber also commented that he was skeptical that prescribers who currently disregard the prescription-release requirement would comply with the confirmation requirement,132 a concern previously raised and discussed in the SNPRM.133 Some commenters also criticized the FTC for, in their words, trying to acquire new authority to target small and midsized businesses, and stated this ran counter to the current trend for Congress and other federal agencies to ‘‘recognize the need to alleviate the administrative burden that federal programs place on physician practices.’’ 134 And several commenters asserted that the Commission should not focus on enforcing requirements against prescribers while contact lens sellers, in their view, are violating Rule provisions in far greater numbers.135 After considering these comments, the Commission continues to believe that some form of retained documentation is necessary to improve the Commission’s enforcement and monitoring ability. As previously noted, the Commission currently faces challenges in enforcing the Rule. Prescribers, whether intentionally or not, currently can fail to release prescriptions yet risk little because consumers are unlikely to file a complaint if they ask for and subsequently receive a prescription. When a consumer does complain to the FTC, typically the only evidence is the word of the consumer against that of the prescriber, making it difficult for the Commission to establish with a degree of certainty whether a violation has occurred. This fact has played a 130 American Academy of Ophthalmology (SNPRM Comment #136). The AAO suggested that the acknowledgment and record-keeping provisions should be imposed on prescribers who have had multiple complaints, and whose non-compliance was verified after allowing prescribers an avenue to respond and defend themselves. 131 American Optometric Association (SNPRM Comment #96). 132 Steinemann (SNPRM Comment #138). 133 SNPRM, 84 FR at 24676, 24681. 134 American Society of Cataract and Refractive Surgery (SNPRM Comment #127). See also Letter from 20 U.S. Senators (SNPRM Comment #38); Letter from Sen. Lisa Murkowski (SNPRM Comment #49). 135 McManus (SNPRM Comment #18); Ulrich (SNPRM Comment #19) (FTC is punishing the wrong actors); Gilberg (SNPRM Comment #46); American Optometric Association (SNPRM Comment #96); American Academy of Ophthalmology (SNPRM Comment #136). VerDate Sep<11>2014 20:17 Aug 14, 2020 Jkt 250001 significant role in the lack of Rule enforcement against prescribers over the last fifteen years, and may be a contributing factor to the high number of contact lens patients who do not currently receive their prescriptions automatically as required by law. While the AOA suggests that the Commission can use its current authority to issue administrative subpoenas and conduct investigative hearings to explore possible Rule violations, an examination of a prescriber’s Confirmation of Prescription Release records allows a much more efficient means of determining whether a prescriber is complying with the Rule, and is much less disruptive and burdensome for the prescriber.136 As for the assertion that prescribers who do not currently comply with prescription release are unlikely to comply with the confirmation requirement, the difference is that in the latter instance, there would be a way to check compliance. If the Commission has concerns about a prescriber’s compliance, it can request patient confirmations or proof of digital delivery, or a sample of such, which should resolve most questions as to whether the prescriber provided prescriptions in accordance with the law. In this way, it would benefit prescribers because they would have a relatively quick and inexpensive way to show the FTC they complied with their automatic-release obligations. Further, the Commission is not attempting to expand its authority to target small businesses. The Commission already possesses the authority under the FCLCA to enforce the Rule for all contact lens prescribers, large and small. The Commission’s Final Rule institutes a more effective mechanism for enforcing and evaluating the authority it already has. And while the Commission recognizes the need to avoid unnecessary government regulations, the Rule itself is, as one commenter put it, ‘‘deregulatory’’ in nature since its purpose is to restore free market competition, not to rein it in.137 If the Rule, as currently applied and enforced, is failing to meet this congressionally mandated goal in some respects, it is the duty of the 136 Serving administrative subpoenas on a widescale basis to prescribers who might not be releasing prescriptions, and requiring that a prescriber identify all of her contact lens customers for the last several months so they could be interviewed, would likely be criticized as excessive and heavy-handed. 137 National Taxpayers Union (SNPRM Comment #149). PO 00000 Frm 00012 Fmt 4701 Sfmt 4700 Commission to find a more effective manner to realize that purpose. With regard to the argument that it is unjust to focus on enforcing the automatic-release provision while not enforcing regulations that apply to sellers, the Commission does not agree with this premise. The Commission is aware of complaints about seller misconduct and is implementing several changes in this Final Rule to improve seller compliance. The Commission has also brought enforcement actions against sellers for violating the Rule and expects it will bring others in the future.138 Moreover, seller noncompliance does not excuse prescriber non-compliance, nor does it provide a justification for the Commission to reject taking action to improve compliance with a different requirement in the Rule. 3. Comments About Whether the Structure of the Contact Lens Market Creates a Need for Verifiable Enforcement of Automatic Prescription Release Many SNPRM commenters focused on the structure of the contact lens market and whether a system in which prescribers sell the items they prescribe creates an inherent conflict that requires additional corrective action by the Commission.139 U.S. Senator Ron Wyden, for example, commented that 138 See, e.g., U.S. v. Duskin, No. 1:18–cv–07359 (N.D. Cal. Dec. 6, 2018) (consent) U.S. v. Kim, No. 1:11–cv–05723 (E.D.N.Y. Feb 7, 2012) (consent); U.S. v. Royal Tronics, Inc, No. 0:11–cv–62491 (S.D. Fla. Jan. 27, 2012) (consent); U.S. v. Thy Xuan Ho, No. 1:11–cv–03419 (D. Minn. Dec. 27, 2011) (consent); U.S. v. Gothic Lens, LLC, No. 1:11–cv– 00159 (N.D. Ga. Feb. 3, 2011) (consent); U.S. v. Jokeshop, LLC, No. 1:11–cv–11221 (D. Mass. Nov. 29, 2011) (consent); U.S. v. Contact Lens Heaven, Inc., No. 0:08–cv–61713 (S.D. Fla. Dec. 3, 2008) (consent); U.S. v. Chapin N. Wright, II, No. 1:08– cv–11793 (D. Mass. Oct. 31, 2008) (consent); U.S. v. BeWild, Inc., No. 2:07–cv–04896 (E.D.N.Y. Dec. 3, 2007) (consent); U.S. v. Pretty Eyes, LLC, No. 1:07–cv–02462 (D. Colo. Nov. 28, 2007) (consent); U.S. v. Walsh Optical, Inc., No. 2:06–cv–03591 (D.N.J. Aug. 30, 2006) (consent); see also FTC Sends Warning Letters to Sellers of Cosmetic Contacts: All Contact Lens Purchases Require a Prescription from a Medical Professional, https://www.ftc.gov/newsevents/press-releases/2019/10/ftc-sends-warningletters-sellers-cosmetic-contacts-all-contact; FTC Issues Warning Letters Regarding the Agency’s Contact Lens Rule, https://www.ftc.gov/newsevents/press-releases/2016/04/ftc-issues-warningletters-regarding-agencys-contact-lens-rule. 139 Citizen Outreach (SNPRM Comment #78) (prescribers’ ability to sell what they prescribe ensures a ‘‘captive market’’); Lens.com (SNPRM Comment #85) (‘‘the current system is rigged against consumers and companies who compete with prescribers’’); Coalition for Contact Lens Consumer Choice (SNPRM Comment #89); Taxpayers Protection Alliance (SNPRM Comment #118); Information Technology & Innovation Foundation (SNPRM Comment #103); National Hispanic Medical Association (SNPRM Comment #146). E:\FR\FM\17AUR2.SGM 17AUR2 Federal Register / Vol. 85, No. 159 / Monday, August 17, 2020 / Rules and Regulations Congress passed the FCLCA ‘‘to address a distorted contact lens marketplace that had seen freedom of choice eroded as prescribers largely sold the contact lenses they prescribed,’’ 140 and another commenter wrote, ‘‘The system here in the U.S. for buying contact lenses is stacked against consumers because the people who issue you your prescription are also allowed to sell you contact lenses at the very same time. Consumers who don’t know their rights are getting ‘trapped in the exam chair’ so to speak, unaware that they can buy lenses elsewhere for lower prices.’’ 141 According to the Information Technology & Innovation Foundation, which describes itself as a nonpartisan research and educational institute, ‘‘the profession has both a powerful economic interest (profits) and a powerful tool (the prescription) to make it more difficult for consumers to buy their lenses from lower-cost providers.’’ 142 In fact, a number of commenters support the Commission’s proposal because, while regulatory in nature, it is designed to promote free market competition and protect consumers’ ability to purchase from the seller of their choice.143 One commenter wrote that the only solution to what she termed ‘‘the inherent structural problem that continues to cause friction between providers and patients’’ is to prohibit prescribers from selling contact lenses.144 The AOA, on the other hand, disputes the premise that the contact lens market is unique, and argues that the fact that prescribers sell what they prescribe does not create an impetus for corrective 140 Letter from Sen. Ron Wyden (SNPRM Comment #5); see also Taxpayers Protection Alliance (SNPRM Comment #118) (‘‘Congress passed the bipartisan Fairness to Contact Lens Consumers Act to protect contact lens wearers. The result was less market distortion and more competition, leading to more choices and lower prices for consumers.’’). 141 National Hispanic Medical Association (SNPRM Comment #146). 142 Information Technology & Innovation Foundation (SNPRM Comment #103). 143 See Americans for Tax Reform (SNPRM Comment #72) (‘‘These changes strike the correct balance between promoting the free market and protecting important consumer rights.’’); Citizen Outreach (SNPRM Comment #78); Taxpayers Protection Alliance (SNPRM Comment #118) (‘‘Although we are often critical of government overreach and work hard to make government smaller, we believe that the FTC’s proposed Contact Lens Rule is a government rule that works for taxpayers and consumers.’’); National Taxpayers Union (SNPRM Comment #149) (‘‘From the perspective of free-market, limited government advocates, the Contact Lens Rule has been one of the most balanced and successful examples of ‘deregulatory rulemaking’ in the FTC’s history.’’). 144 Carafas (SNPRM Comment #39). VerDate Sep<11>2014 20:17 Aug 14, 2020 Jkt 250001 regulation.145 According to the AOA, health care professionals in certain other areas—such as ambulatory surgery centers, orthopedic centers, and dental service providers, among others—also sell what they prescribe or recommend for treatment. Furthermore, according to the AOA, helping patients ‘‘obtain treatment while in their doctor’s office builds strong doctor-patient relationships and promotes patientcentered care.’’ 146 The AOA therefore concludes that ‘‘the Commission seems to have used the inaccurate belief that contact lens prescribers’ role in the market is entirely unique as a justification for implementing new regulations on physicians,’’ and thus, ‘‘the entire argument for supporting prescriber rule changes must be reevaluated.’’ 147 Several commenters also felt that the contact lens market is functioning properly, as evidenced by the relatively large number of contact lens sellers, and by lens prices that appear competitive, and thus there is no need for FTC intervention to modify the Rule.148 As support for this position, the AOA submitted a price-comparison analysis that it stated showed that the average price difference for contact lenses between online sellers and office prescribers was just thirty-two cents.149 According to the AOA, this demonstrates that the market is highly competitive, and thus the FCLCA and Rule are working as intended and, consequently, there is no need for Rule modification and a Confirmation of Prescription Release.150 The Commission does not share this assessment. While there are now a number of different types of sellers, and the market has become more competitive than it was before the Rule,151 prescribers still possess a significantly higher share of contact lens sales than online sellers, mass merchandisers, or retail chains,152 even 145 American Optometric Association (SNPRM Comment #96). 146 Id. 147 Id. 148 Warner (SNPRM Comment #9); Ohio Optometric Association (SNPRM Comment #47); Cutter (SNPRM Comment #81); American Optometric Association (SNPRM Comment #96). 149 American Optometric Association (SNPRM Comment #96). 150 Id. 151 CLR Panel I Tr., supra note 100, at 3–5 (remarks of Steve Kodey and accompanying slides, U.S. Optical Market Overview). 152 Approximately 39% of all contact lenses sales revenue in the U.S. occurs at independent eye care professionals, compared to 18% at conventional chains, 25% at mass merchants and wholesale clubs, and 16% online. Vision Council, U.S. Optical Market Eyewear Overview 4 (2018), https:// www.ftc.gov/sites/default/files/filefield_paths/ PO 00000 Frm 00013 Fmt 4701 Sfmt 4700 50679 though prescriber prices, on the whole, are consistently higher.153 The AOA’s assessment appears to be based on lens price per-packet, rather than per-day or per-year.154 The Commission does not believe per-packet pricing is a fair method of comparison, because it compares some lenses that are effectively sold in a multi-month supply with lenses that are only sold as a single month’s supply. The Commission conducted a re-analysis of the AOA’s data by aggregating to a consistent timeframe in order to compare what consumers might actually spend to wear lenses on a regular basis. This reanalysis—using the data supplied by AOA—determined that the average annual prices of contacts were from $9 to $40 more expensive if purchased from a private practice than from the leading online seller.155 The price difference for an annual supply of lenses was even starker between a private practitioner and a leading mass merchandiser, with private practitioners averaging between $62 and $92 more for an annual supply.156 Likewise, at the Commission’s Contact Lens Workshop, an eye care consultant presented a price survey for sixteen leading contact lens brands and concluded that an annual supply of lenses purchased online steve_kodey_ppt_presentation.pdf. It is also worth noting that while the contact lens retail market has evolved since 2004, it may well have changed less dramatically than many other retail industries have since the internet revolution began diverting sales from brick and mortar to online merchants. 153 See CLR Panel I Tr., supra note 100, at 9 (remarks of Wallace Lovejoy and accompanying slides, Contact Lens Price Ranges By Sales Channel); see also Opinion of the Commission, In the Matter of 1–800 CONTACTS, 4 (‘‘Among brickand-mortar retailers, independent ECPs typically have the highest prices for contact lenses . . . .’’), https://www.ftc.gov/system/files/documents/cases/ docket_no_9372_opinion_of_the_commission_ redacted_public_version.pdf. 154 The Commission has not been able to precisely replicate the thirty-two-cent-difference figure stated by AOA. But by comparing average packet prices in the data supplied, the difference between private practices and online sellers is 35 cents. For the reasons stated, however, the Commission does not believe this figure is an appropriate comparison measure. 155 The average depends on whether a consumer purchased an annual supply all at once (in which case they received a discount from the online retailer) or in individual package increments. The Commission also notes that prices at the ‘‘Leading Online Retailer,’’ which, based on sales and market share, could be 1–800 CONTACTS, might not represent the average online price for contact lenses, and prices at 1–800 CONTACTS, by its own admission, are typically higher than those of both other online sellers and retail club stores. Brief of 1–800 CONTACTS, 1–800 CONTACTS v. Federal Trade Commission (2d Cir. June 12, 2019); see also Opinion of the Commission, In the Matter of 1–800 CONTACTS, 4, https://www.ftc.gov/system/files/ documents/cases/docket_no_9372_opinion_of_the_ commission_redacted_public_version.pdf. 156 The data derives from the ABB Optical Group, Soft Lens Retail Price Monitor (First Quarter 2019). E:\FR\FM\17AUR2.SGM 17AUR2 50680 Federal Register / Vol. 85, No. 159 / Monday, August 17, 2020 / Rules and Regulations averaged $17.56 less than at an independent prescribers’ office, and lenses purchased from a shopper’s club averaged $42.44 less.157 There can be valid reasons for differences in prices among sellers (some sellers may offer more convenience, options, or better customer service), and the Commission does not view price differences between private eye care practitioners and third-party sellers, in and of itself, as dispositive evidence that the market is not functioning in a competitive manner. But the Commission disagrees that the submitted pricing data is proof that the market is functioning in a perfectly competitive manner, and is proof that prescribers are providing patients with their prescriptions. The Commission is also aware that there are other health care professionals who may sell what they prescribe or recommend for treatment, and has not based its proposal solely on a belief that contact lens prescribers’ role and market is unique. Rather, the Commission has considered the structure of the market as a contributing factor in an overall evaluation of the need for improved Rule compliance and enforcement. It must be acknowledged—as it was by Congress when it enacted the FCLCA and directed the FTC to implement the Rule—that it is not in prescribers’ selfinterest for their patients to take prescriptions elsewhere to buy lenses.158 And while it is true that some health care professionals in other fields sell products that they prescribe or recommend for treatment, the sheer volume of contact lens prescribers’ revenue and profit derived from the sale of contact lenses—16–32% of revenue, by some accounts 159—creates a 157 CLR Panel I Tr., supra note 100, at 9 (remarks of Wallace Lovejoy and accompanying slides, Contact Lens Price Ranges By Sales Channel). 158 See H.R. Rep. No. 108–318, at 4–5 (stating that ‘‘[t]he practice of optometrists withholding the prescription has limited the consumer’s ability to shop for the best price and has impacted competition’’ and that obstacles to free market competition are rooted in an ‘‘inherent conflict of interest’’ in that ‘‘[u]nlike medical doctors who are prohibited from selling the drugs they prescribe, eye doctors and optometrists . . . are able to fill the contact lens prescriptions they write’’); see also 149 Cong. Rec. H11564–65 (daily ed. Nov. 19, 2003) (statement of Rep. Stark) (‘‘Eye doctors cite health concerns, but the fact is they have a strong financial incentive to restrict consumer access to the contact lens market.’’). 159 Harris Williams & Co., Vision Industry Update, at 4 (Mar. 2017); Harris Williams & Co., Vision Industry Overview, at 3 (Jan. 2015). Contact Lens Spectrum has estimated the percentage of gross practice revenue from contact lenses to be 30%, and the net practice revenue at 26%, but the estimate does not specify how much of that was derived from sales of lenses versus professional fees for contact lens fittings and examinations. Contact Lens Spectrum, at 19 (Jan. 2019), https:// VerDate Sep<11>2014 20:17 Aug 14, 2020 Jkt 250001 powerful incentive to keep those sales in house. 4. Comments About the Text of the Proposed Confirmation of Prescription Release, and the Options To Include the Confirmation as Part of a Patient’s Prescription or Sales Receipt As noted previously, unlike the twosentence signed-acknowledgment proposal from the NPRM,160 the SNPRM’s Confirmation of Prescription Release proposal did not mandate specific text for the patient’s signed confirmation. Instead, the SNPRM, for convenience, provided optional sample language that prescribers could use but left it up to individual prescribers to draft their own confirmation language if they so preferred.161 The Commission proposed this flexibility in response to commenter concerns that the language of the NPRM’s signed-acknowledgment interfered with the prescriber-patient relationship by imparting the impression that prescribers had done something wrong. By permitting prescribers to draft their own confirmation language or use the provided, shortened sample language, the Commission aimed to allow prescribers to use wording that they believe would be less likely to reflect negatively on the prescribers’ conduct.162 The Commission also proposed to allow prescribers to include the confirmation as part of a patient’s prescription or sales receipt.163 One commenter, the National Association of Optometrists and Opticians (‘‘NAOO’’), praised the new options and flexibility, stating it would ‘‘assist the industry in, and lighten the burdens of, compliance.’’ 164 The NAOO also approved of the FTC sample confirmation language, calling it a ‘‘concise statement of the point of the Rule,’’ and predicting it would be used by most of its members.165 The NAOO did suggest, however, that to avoid bt.editionsbyfry.com/publication/ frame.php?i=552776&p=&pn=&ver=html5. See also Ken Kriviac, How to Hubble-Proof Your Contact Lens Practice, Review of Optometric Business (Jan. 17, 2018) (optometrist stating that 17% of his practice’s total revenue is generated from the sale of contact lens related materials, with another 8% from related professional fees), https:// reviewob.com/can-hubble-proof-contact-lenspractice/. 160 NPRM, 81 FR at 88559. 161 SNPRM, 84 FR at 24683. The sample language provided by the Commission consisted of the following: ‘‘My eye care professional provided me with a copy of my contact lens prescription at the completion of my contact lens fitting.’’ 162 Id. 163 Id. 164 National Association of Optometrists and Opticians (SNPRM Comment #129). 165 Id. PO 00000 Frm 00014 Fmt 4701 Sfmt 4700 potential confusion from a confirmation statement containing additional acknowledgments or unnecessary information, the Rule should clarify that the patient’s confirmation statement should not contain any message or acknowledgment other than that relating to confirmation of prescription release.166 The NAOO also suggested that in instances where a consumer refused to sign the confirmation, the Commission should allow the prescriber to note the refusal and the reason for it as evidence of compliance.167 Other commenters felt that even with the new confirmation-language flexibility, requiring patients to confirm receipt of their prescriptions would imply that prescribers had been improperly withholding them.168 One prescriber commented, ‘‘Why would I need to get a signature of my patient to confirm they received a prescription unless I was doing something wrong that required proof.’’ 169 Others felt that the requirement still unfairly forced them to aid their competition by reminding consumers that they could take their prescriptions to other sellers to have them filled.170 In contrast, some commenters felt that allowing prescribers to draft their own language, and removing the second sentence of the acknowledgment (the requirement that patients confirm the statement: ‘‘I understand I am free to purchase contact lenses from the seller of my choice’’), greatly reduced the effectiveness of the new proposal.171 The online seller 1–800 CONTACTS, in particular, asserted that removal of the second sentence significantly reduced the educational benefit of the 166 Id. 167 Id. 168 Abert (SNPRM Comment #20) (‘‘The additional time required for this unneeded paperwork would disrupt the patient-doctor relationship by communicating to the patients that they should be wary of their physician, and assume that their doctor is a violator of Federal law.’’); Ohio Optometric Association (SNPRM Comment #47) (‘‘The proposal, even in its latest form, will . . . cast public doubt on the integrity of the optometrists and ophthalmologists . . . .’’); Cutter (SNPRM Comment #81); Ritzel (SNPRM Comment #157) (‘‘The idea of me having to have a patient sign a form certifying that I actually gave them a copy of their contact lens prescription—because ‘‘Big Brother’’ is watching—is insulting to myself as a person, and to my profession.’’). 169 Cutter (SNPRM Comment #81). 170 Sanders (SNPRM Comment #61) (‘‘It’s akin to having Target have a big sign next to their own that states, ‘You can get everything here at Walmart as well!’ ’’); Poulter (SNPRM Comment #131) (‘‘It is no more necessary for providers to inform patients of their right to purchase elsewhere than it is for a dentist to let a patient know he can purchase a crown from another party, then return to the dentist to have it placed.’’). 171 Consumer Reports (SNPRM Comment #133); 1–800 CONTACTS (SNPRM Comment #135). E:\FR\FM\17AUR2.SGM 17AUR2 Federal Register / Vol. 85, No. 159 / Monday, August 17, 2020 / Rules and Regulations requirement since consumers who were unaware they had a right to their prescription would not be so informed. 1–800 CONTACTS also stated that eliminating the second sentence made it less likely prescribers would release prescriptions directly after the fitting is complete, and prescribers would instead wait until patients had purchased lenses before giving them their prescriptions and obtaining Confirmations of Prescription Release.172 1–800 CONTACTS also said there is no reason the second sentence would ‘‘sow consumer doubt or harm prescribers’ reputations’’ unless the prescriber had previously been withholding prescriptions.173 The online seller therefore proposed that instead of leaving the wording up to prescribers, the confirmation requirement should again specify the wording required and include the second sentence from the acknowledgment proposal—albeit with a minor adjustment—so as to state, ‘‘I understand that I am free to purchase contact lenses from my eye care professional or the seller of my choice.’’ 174 Inclusion of the option to purchase from the ‘‘eye care professional’’ might alleviate some concern that the notice was instructing consumers to buy from someone other than their prescriber. The consumer advocacy organization Consumer Reports also opposed permitting prescribers to devise their own language of confirmation, and opposed allowing prescribers to make the confirmation part of a prescription copy or sales receipt (Confirmation of Prescription Release options (B) and (C)).175 Instead, Consumer Reports stated that the confirmation should remain a stand-alone document, and suggested requiring the statement, ‘‘My eye care professional provided me with a copy of my contact lens prescription at the completion of my contact lens fitting. I should give a copy of my prescription to the contact lens seller I choose.’’ 176 According to Consumers Reports, there are ‘‘clear advantages to standardized wording,’’ and by 172 1–800 CONTACTS (SNPRM Comment #135) (According to a survey conducted by an independent polling firm on behalf of 1–800 CONTACTS, 38% of consumers who are given their prescription receive it at the same time or only after they have already purchased lenses from the prescriber). 173 Id. (‘‘Because the Confirmation does not require that prescribers provide consumers with any notice of their rights, but merely requires that consumers acknowledge receipt by signature, it is far less likely to either educate consumers or discourage prescribers from pressuring consumers into buying lenses.’’). 174 1–800 CONTACTS (SNPRM Comment #135). 175 Consumer Reports (SNPRM Comment #133). 176 Id. VerDate Sep<11>2014 20:17 Aug 14, 2020 Jkt 250001 instructing consumers to present their prescription to sellers, this would further promote the Commission’s goal of reducing verifications.177 Consumer Reports opined that a statement of confirmation added to the prescriber’s copy of the prescription, or added to an examination receipt, might not be noticed by the patient.178 Some commenters also opined that when prescribers satisfy the confirmation by releasing the prescription electronically (option (D)), prescribers should still provide consumers with a statement advising them that they have a right to their prescription and have the option to buy lenses elsewhere.179 And many commenters raised concerns about whether to allow option (D) altogether, as discussed in more detail below. With respect to allowing options (B) and (C), and permitting prescribers to craft their own wording, the Commission acknowledges that the confirmation proposal may provide less of an immediate educational benefit than the NPRM’s proposed Signed Acknowledgment. By permitting prescribers to include the confirmation on the prescription itself, or on a sales receipt, it is indeed possible that some consumers will fail to understand its purpose, or what it is they are signing. And by not requiring that the confirmation include a sentence specifically informing consumers of their right to have prescriptions filled elsewhere, and not requiring a notice to this effect with digital delivery, some consumers may remain unaware of prescription portability. The Commission, however, continues to believe that the benefit from providing prescribers with greater flexibility, reducing the possible paperwork burden, and limiting potential interference with the prescriber-patient relationship, justifies the trade-off. As noted in the SNPRM, the Confirmation of Prescription Release will maintain much of the effectiveness and enforceability of the Signed Acknowledgment, while reducing the impact on prescribers.180 The Commission also does not believe that requiring patients to sign a confirmation will provoke doubts about the integrity of their prescribers. While patients might draw the conclusion that some prescribers have not always automatically released prescriptions, there is little reason for patients to conclude that their individual prescriber had failed to do so, especially if their prescriber has always provided them with their prescription. It seems more likely that patients may simply conclude that the law has changed. Furthermore, as noted in the SNPRM, consumers are accustomed to signing acknowledgments or receipts. Many pharmacists require patients to acknowledge that they do not have questions upon receiving a prescription; physicians’ offices require visitors to sign in; and patients are accustomed to signing HIPAA acknowledgment forms signifying they received a provider’s Notice of Privacy Practices.181 The Commission is not aware of any evidence that such requirements sow distrust on the part of the person signing the receipt. The Commission believes this will hold true for the Confirmation of Prescription Release, particularly since prescribers can devise their own language of confirmation. The Commission also believes that while it may be advisable for providers to avoid potential patient confusion by not including any other acknowledgments or information on the confirmation document, it is not necessary to expressly prohibit this in the Rule at this time. Such a prohibition might limit the flexibility of the new proposal, and could make it more difficult for providers to avail themselves of options (B) and (C) by including patient confirmation as part of a sales receipt or prescription copy. Moreover, as noted in the SNPRM, while prescribers are free to provide their own language, it would remain a violation for the receipt to include additional information proscribed by the Rule, such as liability waivers or agreements to purchase lenses from the prescriber.182 5. Comments About Option (D) and Using Electronic Delivery for Confirmation of Prescription Release In the SNPRM, the Commission proposed modifying the Rule to allow prescribers to satisfy the automatic prescription release requirement by providing a digital copy in lieu of a paper copy when the patient gives verifiable affirmative consent.183 The Commission noted that using online patient portals and other electronic methods to complete the automatic prescription release offered potential benefits for sellers, prescribers, and patients.184 Patients would be able to 177 Id. 181 Id. 178 Id. 179 Id.; 1–800 CONTACTS (SNPRM Comment #135). 180 SNPRM, 84 FR at 24683. PO 00000 Frm 00015 Fmt 4701 Sfmt 4700 50681 at 24682. at 24683. 183 Id. at 24669. 184 Id. at 24668. 182 Id. E:\FR\FM\17AUR2.SGM 17AUR2 50682 Federal Register / Vol. 85, No. 159 / Monday, August 17, 2020 / Rules and Regulations access their prescriptions and have electronic copies to send to sellers. With the prescription, a seller would no longer need to submit a verification request, which would benefit prescribers by reducing the volume of requests. However, there were also some concerns about portals, including that patients may not be aware of the portal or have difficulty accessing it.185 Because the Commission did not have sufficient information to determine whether solely posting a contact lens prescription on a patient portal would be sufficient to satisfy the Rule’s obligation for prescribers to provide a copy of the prescription after completing the contact lens fitting, the Commission sought comments on its proposed Rule modification.186 The Commission also asked for comments on whether prescribers should be required to maintain any records documenting a patient’s verifiable consent to receive a prescription electronically.187 a. Use of Patient Portals and Patient Consent Many commenters expressed support for allowing prescribers to use electronic methods, such as a patient portal, to provide prescriptions to patients who consent.188 Among the potential benefits, commenters noted the reduction in verification calls or requests for additional copies, easier access to and use of a prescription, lower costs, and flexibility for patients and prescribers.189 Currently, many prescribers already use a portal or other electronic methods to communicate with and, in some instances, provide 185 Id. 186 Id. at 24669. at 24690. 188 See, e.g., Liao (SNPRM Comment #2); Coalition for Contact Lens Consumer Choice (SNPRM Comment #89); Consumer Action (SNPRM Comment #101); Information Technology & Innovation Foundation (SNPRM Comment #103); Alcon Vision, LLC (SNPRM Comment #117); National Association of Optometrists and Opticians (SNPRM Comment #129); CooperVision, Inc. (SNPRM Comment #130) (noting that electronic delivery of a prescription is ‘‘a common-sense, low burden method of giving patients better access to their prescriptions’’); 1–800 CONTACTS (SNPRM Comment #135); Attorneys General of 27 States (SNPRM Comment #139); National Hispanic Medical Association (SNPRM Comment #146); Backus (WS Comment #1650). 189 Americans for Tax Reform (SNPRM Comment #72); Coalition for Contact Lens Consumer Choice (SNPRM Comment #89); Consumer Action (SNPRM Comment #101); Information Technology & Innovation Foundation (SNPRM Comment #103); National Association of Optometrists and Opticians (SNPRM Comment #129); CooperVision, Inc. (SNPRM Comment #130); Consumer Reports (SNPRM Comment #133). 187 Id. VerDate Sep<11>2014 20:17 Aug 14, 2020 Jkt 250001 prescriptions to their patients,190 and use of electronic methods is expected to increase in the future.191 For example, one survey found that approximately 64.2% of eye care professionals communicated with patients by text message, of which 26.4% used it to respond to personal questions about the patient’s eye health.192 Because a significant percentage of eye care providers already use electronic communications and portals, the Commission believes that the required, automatic prescription release could be completed effectively through a digital copy when a patient provides verifiable affirmative consent. Verifiable affirmative consent means that a patient must have provided his or her consent to the prescriber in a way that can be later confirmed. A signed consent form, an email from the patient to the prescriber, or an audio recording from a telephone conversation with a patient would be examples of verifiable affirmative consent. Notification through, for example, a posted office sign or a general written notice of office policies or practices would not constitute affirmative consent because patients have not indicated to the prescriber whether or not they consent. Several commenters supported the use of electronic methods, but had a variety of concerns or proposed changes. Some thought patients might prefer a paper copy instead of an electronic copy of their prescription, including people who are older, reluctant to use technology or worried 190 See, e.g., Coalition for Contact Lens Consumer Choice (SNPRM Comment #89); American Optometric Association (SNPRM Comment #96); National Association of Optometrists and Opticians (SNPRM Comment #129) (stating that practice management systems and electronic health records are easily available at reasonable prices); Sikes (SNPRM Comment #114); Klepfisz (SNPRM Comment #140); Eklund (WS Comment #502); Holland (WS Comment #513); Reed (WS Comment #749); Gitchell (WS Comment #759); Andrews (WS Comment #1014); Carvell (WS Comment #1021); Cecil (WS Comment #1892); Kuryan (WS Comment #3472); Hopkins (NPRM Comment #184); Wilson (NPRM Comment #1310); Grove (NPRM Comment #1702); MacDonald (NPRM Comment #2118); Andrus (NPRM Comment #3345). 191 FTC, The Contact Lens Rule and the Evolving Contact Lens Marketplace, Panel V: Prescription Release & Consumer Choice Tr. at 18–21 (Mar. 7, 2018), https://www.ftc.gov/system/files/documents/ public_events/1285493/panel_v_prescription_ release_and_consumer_choice.pdf [hereinafter CLR Panel V Tr.]. 192 Jobson Research, ECP Digital Solutions Study (2019) (also finding that of those surveyed, approximately 74.4% contacted their patients by email, of which 45.5% used it to respond to personal questions about the patient’s eye health). As noted in the SNPRM, another survey showed that approximately 30% of patients were offered access to a portal during their last eye exam and that 29% chose to use the portal. SNPRM, 84 FR at 24668 n.50. PO 00000 Frm 00016 Fmt 4701 Sfmt 4700 about online privacy or identity theft, unable to navigate a cumbersome portal, without internet or smartphone access, or not proficient in English.193 The Commission shares these concerns and the Final Rule thus maintains the ability for patients who prefer a paper copy for any reason to obtain such a copy. Even if a prescriber offers electronic delivery, a patient could decline to provide consent. Likewise, prescribers who are concerned about the security or costs of electronic methods can continue providing paper copies.194 The Final Rule neither compels prescribers to offer prescription release by an electronic method nor requires that patients accept their prescription by electronic method when offered by the prescriber. One seller urged the Commission to require that the prescribers, when seeking affirmative consent, identify to patients the specific method of electronic delivery that would be used.195 The Commission believes that requiring prescribers to identify the specific method or methods 196 would allow patients to make a more informed decision and increase awareness of how the prescription would be provided if they were to consent. It is also possible that a patient prefers one method of electronic communication, but not others.197 Therefore, the Commission is amending the definition of ‘‘Provide to the patient a copy’’ to require that prescribers who choose to offer an electronic method, identify the specific method or methods to be used and, if a patient consents, have evidence of verifiable affirmative consent to the identified method or methods. Regarding patient portals specifically, some commenters expressed concerns that: (1) Patients would be unaware that their prescription is on a portal; (2) there could be a delay in posting prescriptions to the portal; or (3) prescribers might intentionally make portals difficult to use, post prescriptions without telling their patients, or confuse patients into thinking that they must buy lenses from 193 R Street (SNPRM Comment #15); Americans for Tax Reform (SNPRM Comment #72); Coalition for Contact Lens Consumer Choice (SNPRM Comment #89); American Optometric Association (SNPRM Comment #96); National Hispanic Medical Association (SNPRM Comment #146); National Taxpayers Union (SNPRM Comment #149). 194 American Optometric Association (SNPRM Comment #96); American Society of Cataract and Refractive Surgery (SNPRM Comment #127). 195 1–800 CONTACTS (SNPRM Comment #135). 196 A request for consent that states that the prescription would be delivered electronically, but does not state the method, such as email, text, or portal, would not be adequate. If more than one method is offered, prescribers must specifically identify each one. 197 1–800 CONTACTS (SNPRM Comment #135). E:\FR\FM\17AUR2.SGM 17AUR2 Federal Register / Vol. 85, No. 159 / Monday, August 17, 2020 / Rules and Regulations them.198 They urged the Commission to require that prescribers notify patients when a prescription is available on the portal, provide instructions on how to access the portal, or confirm that the prescription has been received.199 The Commission believes that the Final Rule provides adequate safeguards for patients who have opted to receive their prescription on a portal. As noted in the SNPRM, the use of a portal or other electronic method does not change the timing of when a prescriber must provide a copy of the contact lens prescription.200 A prescriber must provide the prescription immediately after the completion of the contact lens fitting, or in the case of a renewal, when a prescriber determines that no change to the existing prescription is required.201 Furthermore, prescribers can only use a portal to satisfy their obligation under § 315.3(a)(1) when they have affirmative consent to the specific method or methods of electronic delivery. Therefore, patients should be aware that their prescription will be provided electronically using the method to which they consented. The Rule also requires that patients be able to access, download, and print the prescriptions from the portal.202 If patients were to have any problems with using the portal, they could revoke their consent and request a paper copy.203 Notwithstanding these safeguards, the Commission encourages prescribers to provide instructions to patients who may encounter difficulties accessing their portal. The Commission believes that the Rule, with the modification to require that prescribers identify the specific electronic method to be used, balances the interests of prescribers and patients by offering a flexible method that could reduce the burden on 198 R Street (SNPRM Comment #15); Lens.com (SNPRM Comment #85); Coalition for Contact Lens Consumer Choice (SNPRM Comment #89); Consumer Action (SNPRM Comment #101); Information Technology & Innovation Foundation (SNPRM Comment #103); 1–800 CONTACTS (SNPRM Comment #135); National Hispanic Medical Association (SNPRM Comment #146); Senator Mike Lee (SNPRM Comment #159). 199 R Street (SNPRM Comment #15); Information Technology & Innovation Foundation (SNPRM Comment #103); Consumer Reports (SNPRM Comment #133); 1–800 CONTACTS (SNPRM Comment #135); Senator Mike Lee (SNPRM Comment #159). 200 SNPRM, 84 FR at 24669 n.54. 201 Id. 202 The Commission does not have any evidence that prescribers are intentionally making portals difficult for their patients to use. However, such conduct, if it were to occur, could violate the Rule because patients would not be able to access their prescription. 203 Patients could also request an additional copy under 16 CFR 315.3(a)(3). VerDate Sep<11>2014 20:17 Aug 14, 2020 Jkt 250001 prescribers and allow patients greater access to their prescriptions.204 Furthermore, some commenters want a paper copy to be provided in addition to the electronic copy,205 but the Commission declines to adopt this suggestion because requiring both copies would undercut a benefit of using electronic methods and be unnecessary for patients who have expressed a preference for an electronic copy. Finally, a commenter states that telemedicine prescribers should not be required to provide paper prescriptions.206 Although patients who opt for telemedicine might be more comfortable with technology and receiving health care online,207 some patients may still prefer their prescription on paper. Since telemedicine providers should have been providing a paper copy under the current Rule, continuation of this practice, when a patient does not consent to electronic delivery, should not be impractical or overly burdensome. b. Requirement To Maintain Records of Patient Consent In the SNPRM, the Commission proposed requiring that prescribers obtain affirmative consent in order to provide a prescription electronically, but did not require that prescribers maintain evidence of consent. In response, several commenters have urged the Commission to require that prescribers maintain records pertaining to patients’ affirmative consent.208 According to some of these commenters, a record of consent would allow more effective compliance monitoring, while the burden of storing such a record 204 Consumer Action appears to encourage the Commission to provide further guidance on portal design in the Rule. SNPRM Comment #101. Given the potential for future developments in technology and the differences among prescribers’ practices and current software, the Commission declines to mandate requirements on portal design. See CLR Panel V Tr., supra note 191, at 18–21 (discussing the variety of electronic-health-records programs available from ‘‘hundreds’’ of ECH vendors, with each program based on different standards and providing varying degrees of functionality and compatibility). 205 Americans for Tax Reform (SNPRM Comment #72); Lens.com (SNPRM Comment #85); Coalition for Contact Lens Consumer Choice (SNPRM Comment #89); Consumer Action (SNPRM Comment #101); Consumer Reports (SNPRM Comment #133). 206 Simple Contacts (SNPRM Comment #87). 207 Id. 208 Consumer Action (SNPRM Comment #101); Information Technology & Innovation Foundation (SNPRM Comment #103); National Association of Optometrists and Opticians (SNPRM Comment #129); Consumer Reports (SNPRM Comment #133); 1–800 CONTACTS (SNPRM Comment #135). PO 00000 Frm 00017 Fmt 4701 Sfmt 4700 50683 would be minimal.209 By contrast, the AOA states that prescribers should not be required to maintain records of consent because the AOA believes it would be burdensome 210 and ‘‘provides no obvious benefit to the patient’’ since ‘‘the likelihood of harm from a patient receiving a contact lens prescription electronically is low to nonexistent.’’ 211 However, other commenters countered that there is a potential for harm since patients who do not consent might not realize that they received their prescription electronically, or might be unable to access it.212 The Commission finds persuasive the arguments in favor of requiring a record of patient consent to electronic delivery. The burden of retaining a record of patient consent should be minimal, since prescribers who opt for electronic delivery of prescriptions will, in all likelihood, obtain and/or store such consent electronically. Even if they do not, it should not take any longer to obtain and store patient consent to electronic delivery than it would to obtain and store a patient’s Confirmation of Prescription Release via options (A), (B) or (C). Furthermore, a prescriber is not required to offer patients a digital prescription. Rather, it is at his or her option. Moreover, consent to receipt of a digital copy would aid in enforcing the Rule since, 209 Consumer Action (SNPRM Comment #101) (stating that the cost of storing digital records is not burdensome); Information Technology & Innovation Foundation (SNPRM Comment #103) (stating that the cost of storing a consent form would be virtually zero). 210 See also American Society of Cataract and Refractive Surgery (SNPRM Comment #127) (discussing the administrative burden related to maintaining records of consent). Other commenters contend that the burden of storing these records would be minimal. Information Technology & Innovation Foundation (SNPRM Comment #103). 211 American Optometric Association (SNPRM Comment #96). The AOA also asserts that ‘‘[p]atients do not have to consent to the electronic delivery of other prescriptions.’’ However, there may be differences between contact lens prescriptions and some other types of medical prescriptions. In many instances, other types of prescriptions being delivered electronically are not being sent to a patient, but rather to a pharmacy that then fills the prescription. When a prescription is sent to a pharmacy, the patient would likely have selected or have knowledge of the receiving pharmacy. In 2013, 57% of prescriptions nationally were sent electronically from physicians to pharmacies, with the rate in some states over 80%. U.S. Dep’t of Health & Human Servs., The Office of the National Coordinator for Health Information Technology, ‘‘E-Prescribing Trends in the United States’’ 8 (2014) (stating also that 96% of all community pharmacies in the U.S. accept eprescriptions). 212 R Street (SNPRM Comment #15); Coalition for Contact Lens Consumer Choice (SNPRM Comment #89); Consumer Action (SNPRM Comment #101); National Hispanic Medical Association (SNPRM Comment #146); National Taxpayers Union (SNPRM Comment #149). E:\FR\FM\17AUR2.SGM 17AUR2 50684 Federal Register / Vol. 85, No. 159 / Monday, August 17, 2020 / Rules and Regulations without a record of consent, there would be no way for the Commission to confirm that patients who were given their prescriptions electronically agreed to such electronic delivery, and had the ability to access their prescriptions in this manner. The Final Rule will thus require that prescribers keep records or evidence of a patient’s affirmative consent to a digital copy for at least three years. Although some commenters have sought longer retention periods,213 three years is a time period consistent with other recordkeeping obligations in the Rule. 6. Comments About Alternatives to the Confirmation of Prescription Release In addition to the suggestions— discussed previously—that the Commission increase its enforcement of the current Rule, or impose new requirements only as a penalty for specific providers found in noncompliance,214 some commenters proposed alternative means of ensuring that consumers receive their prescriptions. a. Signage Several commenters reiterated the idea—raised and discussed in some detail in the SNPRM 215—that instead of requiring a patient acknowledgment or confirmation, the Commission ought simply to require that prescribers post signs informing consumers of their right to their prescriptions.216 In its SNPRM, the Commission acknowledged that signage offers some of the benefits of a patient confirmation, but concluded that it had significant drawbacks: In the particular environment of a prescriber’s office, far fewer consumers would learn of their rights from a sign than from being asked to sign a receipt; signage would serve as less of a reminder to prescribers and their staff to release prescriptions; signage would do nothing to aid the Commission in monitoring and enforcing the prescription-release requirement; and relying on patients to notice a sign and ask for their prescriptions put the onus on 213 Information Technology & Innovation Foundation (SNPRM Comment #103) (requesting five years); 1–800 CONTACTS (SNPRM Comment #135) (requesting that the record be kept as long as the affirmative consent is active). State laws could require that prescribers maintain these records for longer than three years. 214 American Optometric Association (SNPRM Comment #96). 215 SNPRM, 84 FR at 24679. 216 Letter from 20 U.S. Senators (SNPRM Comment #38); Letter from Sen. Lisa Murkowski (SNPRM Comment #49); Cutter (SNPRM Comment #81); American Optometric Association (SNPRM Comment #96); Gilbert (SNPRM Comment #119); Patel (SNPRM Comment #123); Letter from N.D. State Sen. Judy Lee (SNPRM Comment #161). VerDate Sep<11>2014 20:17 Aug 14, 2020 Jkt 250001 consumers to enforce the Rule, and would effectively amend the FCLCA’s automatic-release provision to releaseupon-request, a statutory revision only Congress can make.217 The Commission also noted that relying on consumers to ask for their prescriptions is problematic since consumers might not see the sign, or might be uncomfortable asking their prescribers for their prescriptions.218 Based on those reasons, the Commission declined to propose signage as an alternative to a Confirmation of Prescription Release.219 Some SNPRM commenters agreed with the Commission’s position, stating that ‘‘requiring prescribers to post signs doesn’t work,’’ 220 and asserting that in California, where a state law requires contact lens prescribers to post signs detailing patient rights, some optometrists fail to comply, or post the signs in locations consumers are unlikely to see them.221 In contrast, other commenters contended that the Commission should reconsider the signage alternative, reiterating that it would be less burdensome and intrusive for prescribers and could address the FTC’s educational objectives without costly regulation.222 The AOA also took issue with the fact that the Commission cited HHS’s implementation of a signedacknowledgment for a prescriber’s HIPAA obligation instead of opting for signage.223 According to the AOA, anything HHS concluded when it constructed the HIPAA signedacknowledgment is no longer relevant since HHS is now considering eliminating the requirement and switching to signage in order to reduce 217 SNPRM, 84 FR at 24682–83. at 24682. 219 Id. at 24682–83. 220 Coalition for Contact Lens Consumer Choice (SNPRM Comment #89); Consumer Action (SNPRM Comment #101). 221 Americans for Tax Reform (SNPRM Comment #72). As noted in the SNPRM, the Commission does not have empirical data about prescriber compliance with the state signage requirement, 16 CCR 1566, which has been in effect in California since 1994. However, an analysis of consumer survey evidence provided by Survey Sampling International indicates that regardless of signage, Californians do not automatically receive their prescriptions in substantially greater numbers than residents of states without a signage requirement. SNPRM, 84 FR at 24679. 222 Kochik (SNPRM Comment #8) (stating that the real issue is that patients are unaware of the law, and so the solution is signage); Letter from 20 U.S. Senators (SNPRM Comment #38); Letter from Sen. Lisa Murkowski (SNPRM Comment #49). 223 American Optometric Association (SNPRM Comment #96). The obligation in question is the HIPAA requirement that health care providers provide patients with a Notice of Privacy Practices (‘‘NPP’’) and obtain a patient’s signature acknowledging receipt of same. Notice of Privacy Practices for Protected Health Information, 14 CFR 164.520(c)(2)(ii). 218 Id. PO 00000 Frm 00018 Fmt 4701 Sfmt 4700 the burden on health care practitioners.224 Furthermore, according to the AOA, ‘‘the physician community is united in its belief’’ that the HIPAA signed-acknowledgment should be eliminated, and this shows that such acknowledgment requirements constitute poor policy, and signage is a better option.225 While it is true that HHS is presently evaluating whether to eliminate the HIPAA Notice of Privacy Practices signed-acknowledgment requirement, the Commission’s Confirmation of Prescription Release proposal, and the decision not to allow signage as an alternative, does not rely on the HIPAA signed-acknowledgment requirement as precedent. In the SNPRM, the Commission merely referenced aspects of HIPAA’s signed-acknowledgment requirement and HHS’s evaluation of the regulatory burden as informative when considering whether to require some form of patient confirmation of 224 American Optometric Association (SNPRM Comment #96) (quoting Request for Information on Modifying HIPAA Rules to Improve Coordinated Care, 83 FR 64302, 64302–03 (2018), https:// www.govinfo.gov/content/pkg/FR-2018-12-14/pdf/ 2018-27162.pdf#page=1.) 225 American Optometric Association (SNPRM Comment #96). It is worth noting that a review of the comments submitted in response to the recent HHS proposal to eliminate HIPAA’s signedacknowledgment requirement reveals that while many health care providers do consider it an unnecessary use of staff time and resources, other health care providers support the acknowledgment requirement, and several noted that the burden of obtaining a patient’s signed acknowledgment is relatively minimal. See, e.g., Jackson Health System (Comment in Response to Request For Information, Office for Civil Rights, Department of Health and Human Services [hereinafter ‘‘HHS RFI Comment’’] #467) (does not support modifying the requirement because signed NPP acknowledgment forms are ‘‘useful’’ to prove that the NPP was provided to the patient); Dr. Mitchell Strauss (HHS RFI Comment #851) (‘‘The signature is the only way of confirming for posterity that the NPP was discussed. If this step is no longer required, it will be far too easy for practices to stop making the effort for acknowledgement of the NPP.’’); Multnomah and Clackmas Counties (HHS RFI Comment #926) (foresees adverse consequences—potential complaints and misunderstandings—if signed acknowledgment requirement is removed); San Francisco Department of Public Health (HHS RFI Comment #1241) (‘‘Having a written record assures patients and covered entities that patients are informed about privacy practices.’’); American College of Osteopathic Family Physicians (HHS RFI Comment #1262) (strongly believes that there must be some level of accountability and responsibility for ensuring patients understand their privacy rights); Massachusetts Department of Mental Health (HHS RFI Comment #1003) (‘‘The burden is negligible.’’); Missouri Hospital Association (HHS RFI Comment #1175) (‘‘MHA’s members do not find the requirement cumbersome.’’); Cigna (HHS RFI Comment #1132) (‘‘Obtaining acknowledgment of receipt is not an operational burden [and] the burden to maintain document of acknowledgment or declination is minimal.’’). HHS RFI Comments are available at https://www.regulations.gov/ docketBrowser?rpp=25&po=0&D=HHS-OCR-20180028. E:\FR\FM\17AUR2.SGM 17AUR2 Federal Register / Vol. 85, No. 159 / Monday, August 17, 2020 / Rules and Regulations prescription release.226 Any other reliance on the HIPAA signedacknowledgment requirement is generally inappropriate since that signed-acknowledgment requirement differs from the Commission’s confirmation proposal in important respects. The primary intent of the HIPAA signed-acknowledgment was to provide patients an opportunity to review the provider’s Notice of Privacy Practices, discuss concerns related to their private health information, and request additional confidentiality.227 It was not to remedy a lack of compliance by doctors with HIPAA requirements. Unlike this Rule review, the HHS record does not contain empirical evidence showing that doctors are not fulfilling their obligations to provide Notices of Privacy Practices to patients, and only a handful of commenters to HHS’s recent Request for Information even suggested that this could occur should the HIPAA signed acknowledgment be removed.228 This contrasts sharply with the circumstances of the Commission’s proposed Confirmation of Prescription Release, which is intended to remedy a documented compliance gap resulting, at least to some extent, from inherent incentives that may discourage prescribers from providing patients with their prescriptions. The Commission continues to believe that for purposes of automatic prescription release, signage would be significantly less effective than the proposed Confirmation of Prescription Release. None of the comments to the SNPRM presented any data or evidence that would counter the Commission’s prior conclusion. The AOA’s argument that the HIPAA signed-acknowledgment experience should not be looked to as a model does not alter the Commission’s determination that there is a compelling need for a verifiable method of ensuring that contact lens patients receive their prescriptions. b. Educational Programs as an Alternative to Confirmation of Prescription Release Some commenters opined that instead of having consumers confirm that they received their prescription, the best manner to inform consumers about their 226 SNPRM, 84 FR at 24682. for Information on Modifying HIPAA Rules to Improve Coordinated Care, Office for Civil Rights, Department of Health and Human Services, 83 FR at 64308. 228 See generally Comments in Response to Request for Information on Modifying HIPAA Rules to Improve Coordinated Care, Office for Civil Rights, Department of Health and Human Services, https://www.regulations.gov/ docketBrowser?rpp=25&po=0&D=HHS-OCR-20180028. 227 Request VerDate Sep<11>2014 20:17 Aug 14, 2020 Jkt 250001 prescription rights was through an educational program.229 According to one contact lens manufacturer, the FTC and sellers should continue to ‘‘communicate to patients through social media, websites, advertising, and other channels so that patients become even more aware that they can leave their final fitting with a copy of their right prescription.’’ 230 Others suggested that the Commission could partner with the Centers for Disease Control and the Food and Drug Administration (‘‘FDA’’) to produce public service announcements informing patients of their rights.231 Another commenter suggested that instead of a signed confirmation, patients’ rights to their prescriptions could be ‘‘spelled out in the entry forms a patient signs when they check in.’’ 232 Similarly, the AOA suggested that a ‘‘patient bill of rights for contact lens wearers’’ could be provided to patients that would include FDA information on considerations for buying lenses.233 One commenter, the NAOO, said that even with a Confirmation of Prescription Release, the Commission should focus on educating the public about its rights to automatic release of a prescription.234 The Commission agrees that educating the public can aid in increasing the likelihood that contact lens users will receive their prescriptions after a fitting.235 Consumer education in itself, however, whether provided via information entry forms, a patients’ bill of rights, advertising, or public service announcements, would not have a significant impact on prescriber compliance with automatic prescription release, and would not increase the Commission’s ability to monitor and enforce the Rule. The proposed education alternatives would also place a burden on consumers to enforce their own rights, an approach the Commission has rejected repeatedly in the past when considering whether to amend the Contact Lens Rule and Eyeglass Rule to release-upon229 Abert (SNPRM Comment #20); Tran (SNPRM Comment #94); CooperVision, Inc. (SNPRM Comment #130). 230 CooperVision, Inc. (SNPRM Comment #130). 231 American Optometric Association (SNPRM Comment #96); Tran (SNPRM Comment #94). 232 Cutter (SNPRM Comment #81). 233 American Optometric Association (SNPRM Comment #96). 234 National Association of Optometrists and Opticians (SNPRM Comment #129). 235 The Commission educates consumers on their rights under the Contact Lens Rule through a variety of sources, including blog posts, Facebook, Twitter, and on the FTC’s website. See, e.g., https:// www.consumer.ftc.gov/articles/0116-prescriptionglasses-and-contact-lenses. PO 00000 Frm 00019 Fmt 4701 Sfmt 4700 50685 request.236 Therefore, while the Commission believes education about the Rule and its automatic-prescriptionrelease provision is important, the Commission does not believe education should be the sole means of improving Rule compliance. 7. Comments About the Burden and Benefits of the Confirmation of Prescription Release Proposal Many commenters stated that even with the proposed modifications to increase flexibility, the Confirmation of Prescription Release requirement is still overly burdensome for prescribers.237 According to commenters, eye care practitioners are already overburdened by regulatory requirements, and the confirmation requirement would divert resources from patient care, increase health care costs, and might even drive some prescribers to cease prescribing contact lenses or close their practices.238 More specifically, the AAO stated that many of the options for obtaining patient confirmation would require practices to change procedures and alter administrative forms.239 Others noted 236 See Eyeglass I, 43 FR at 23998 (stating that relying upon release-upon-request is problematic because many consumers are unaware of their right to a prescription, and because the right should be ‘‘immunized from an evidentiary squabble over whether the consumer actually did or did not request the prescription’’); Final Trade Regulation Rule, Ophthalmic Practice Rules 54 FR 10285, 10286–87 (Mar. 13, 1989) [hereinafter Eyeglass II] (rejecting a proposal to change the Rule to releaseupon-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’’). 237 Warner (SNPRM Comment #9); Mass Mail Campaign (SNPRM Comment #25) (saying the requirement imposed ‘‘massive new costs and farreaching new requirements on all contact lens prescribing’’); Yokum (SNPRM Comment #53); Staup (SNPRM Comment #104); American Society of Cataract and Refractive Surgery (SNPRM Comment #127); Letter from Sen. Lisa Murkowski (SNPRM Comment #49). 238 Goldstein (SNPRM Comment #14) (‘‘The economic burdens of administrative compliance with these new regulations would except in rare cases encourage me not to fit or prescribe contact lenses.’’); Pierce (SNPRM Comment #17) (will ultimately lead to higher health care costs, might have to raise fees); Mass Mail Campaign (SNPRM Comment #25); Shum (SNPRM Comment #80) (‘‘Adding more paperwork and scanning work—and making it required on everyone—doesn’t sound like it would be a big deal, but to a small practice it’s huge.’’); Cinalli (SNPRM Comment #93) (new regulation will close many practices); Klepfisz (SNPRM Comment #140) (burden has the potential to put some prescribers out of business). 239 American Academy of Ophthalmology (SNPRM Comment #136). E:\FR\FM\17AUR2.SGM 17AUR2 50686 Federal Register / Vol. 85, No. 159 / Monday, August 17, 2020 / Rules and Regulations that the requirement to dispense paper copies of the confirmation to patients runs counter to the trend towards electronic records, particularly for those who have already invested in an electronic recordkeeping system.240 One commenter opined that patients ought to bear more responsibility for their own health care.241 Others noted that the proposal was ‘‘going against the tide’’ by adding a new regulation at a time when some government agencies are looking to reduce regulations.242 Some commenters believed the Commission was underestimating the burden to obtain confirmations and preserve the records, and provided their own estimates, including that it would cost $10,000 per year,243 or would require 10 minutes per patient for a total of ‘‘850 man-hours per year,’’ 244 the equivalent of about 21 additional weeks of work. The AOA, which had previously estimated the cost of the signed-acknowledgment requirement to be as high as $18,795 per optometrist,245 did not submit a new burden estimate for the Confirmation of Prescription Release proposal, but reiterated its belief that the Rule’s burden falls disproportionately on prescribers, and expressed concern that the estimated financial burden for the Rule in the 2019 SNPRM is higher than the financial burden estimate cited for the NPRM’s signed-acknowledgment proposal.246 Some commenters also stated that the use of option (D), electronic delivery, would not significantly reduce their burden, since it would require them to update their systems or invest in expensive 240 Lowe (SNPRM Comment #40); Reeder (SNPRM Comment #55) (signature upon receipt of prescription is ‘‘burdensome and counter to other initiatives to reduce paper held by offices’’); Boyer (SNPRM Comment #59) (‘‘We try very hard to reduce paper waste . . . . [This] will undo our efficiency and distract our staff from our daily caseload, resulting in increased costs and reduced care.’’). 241 Steiner (SNPRM Comment #7). 242 American Optometric Association (SNPRM Comment #96); American Society of Cataract and Refractive Surgery (SNPRM Comment #127). 243 Pierce (SNPRM Comment #17). 244 Steinemann (SNPRM Comment #65). 245 American Optometric Association (NPRM Comment #3830). This estimate was cited again by some commenters to the SNPRM. Koerber (SNPRM Comment #41); American Society of Cataract and Refractive Surgery (SNPRM Comment #127). In the SNPRM, the Commission explained that it could not accord this estimate significant weight because it was based not on the cost of the Commission’s proposed Signed Acknowledgment but on the overall cost of government regulations (including those already in place), and because the survey had various methodological limitations. SNPRM, 84 FR at 24677. 246 American Optometric Association (SNPRM Comment #96). VerDate Sep<11>2014 20:17 Aug 14, 2020 Jkt 250001 technology.247 According to the AOA, many prescribers would not be able to opt for electronic delivery because of limitations in electronic health records systems, privacy and data-security concerns, and state regulations that might not permit prescription posting to portals.248 Other commenters disputed that the burden would be significant, and stated that the confirmation requirement would not add significant costs or time.249 According to the Information Technology & Innovation Foundation, prescriber claims that the proposal would require significant additional staff training are overstated.250 Another commenter, a prescriber, stated, ‘‘In our office, we already have patients sign a contact lens agreement before the contact lens evaluation process. I don’t see a problem adding a document at the end of the process and having the patient sign an acknowledgment of rx receipt.’’ 251 One commenter contended that while there would be some burden on eye care providers, it represented just a ‘‘tiny fraction’’ of the industry’s overall revenue, and would be far outweighed by the benefits.252 Others asserted that allowing prescribers to provide patients with digital copies would save both prescribers and patients time and money.253 Some commenters suggested that the Commission was actually overestimating the burden imposed by the confirmation requirement.254 1–800 CONTACTS, for example, submitted a new analysis from Stanford University Professor Laurence Baker, which called the assumptions used in the 247 American Society of Cataract and Refractive Surgery (SNPRM Comment #127). 248 American Optometric Association (SNPRM Comment #96). 249 Tobias (SNPRM Comment #45); Rawson (SNPRM Comment #68); (Citizen Outreach (SNPRM Comment #78); Consumer Action (SNPRM Comment #101); Information Technology and Innovation Foundation (SNPRM Comment #103); National Association of Optometrists and Opticians (SNPRM Comment #129); Consumer Reports (SNPRM Comment #133). 250 Information Technology and Innovation Foundation (SNPRM Comment #103) (‘‘A few minutes of instruction, coupled with reading a oneor two-page memo should more than suffice.’’). 251 Gilberg (SNPRM Comment #46). 252 Taxpayer Protection Alliance (SNPRM Comment #118) (overall burden of the new requirement would be minimal and outweighed by the substantial benefit of having significantly more patients in possession of their prescription). 253 Grimm (SNPRM Comment #36) (proposal to allow new methods for providing prescriptions will help relieve paperwork burden); Coalition for Contact Lens Consumer Choice (SNPRM Comment #78); Liao (SNPRM Comment #2) (portal proposal will make automatic release more efficient). 254 National Taxpayers Union (SNPRM Comment #149); 1–800 CONTACTS (SNPRM Comment #135, Ex. A). PO 00000 Frm 00020 Fmt 4701 Sfmt 4700 Commission’s burden analysis very ‘‘conservative,’’ and estimated that a reduction in verifications by just 15% would be sufficient to offset all of the costs of the confirmation requirement.255 The NAOO also felt the burden would be ‘‘minimal,’’ and opined that with more patients in possession of their prescriptions, there would be fewer orders relying on the verification process, and thus fewer verifications for prescribers to have to take the time to respond to.256 NAOO also opined that with more practitioners moving to practice management systems and electronic health records, digital delivery of contact lens prescriptions is a ‘‘very feasible’’ option for many prescribers, which would reduce the burden of the confirmation requirement.257 Some commenters also felt that the Commission should not give much weight to burden concerns raised by prescribers due to their history of not complying with their prescriptionrelease obligations.258 The National Hispanic Medical Association, for example, stated that the focus on the burden for prescribers was ‘‘upsetting when one remembers just how many patients are being robbed of their right to lower prices and more convenient shipping and being denied a copy of something that they worked hard to pay for, namely, their own prescription.’’ 259 The Commission has considered the burden the Confirmation of Prescription Release requirement would place on prescribers. As stated in the SNPRM, the evidentiary record does not establish that the burden will be substantial.260 Nothing received or revealed since the SNPRM alters that assessment. In fact, numerous health care providers— commenting on their experience with HIPAA—said that the burden of requiring that a patient sign a confirmation-type receipt is ‘‘minimal,’’ 261 ‘‘negligible,’’ 262 or ‘‘not significant.’’ 263 And while AOA is 255 1–800 CONTACTS (SNPRM Comment #135). Association of Optometrists and Opticians (SNPRM Comment #129). 257 Id. 258 Information Technology & Innovation Foundation (SNPRM Comment #103); 1–800 CONTACTS (SNPRM Comment #135); National Hispanic Medical Association (SNPRM Comment #146). 259 National Hispanic Medical Association (SNPRM Comment #146). 260 SNPRM, 84 FR at 24681. 261 Multnomah and Clackamas Counties (HHS RFI Comment #926); Cigna (HHS RFI Comment #1132). 262 Massachusetts Department of Mental Health (HHS RFI Comment #1003). 263 San Francisco Department of Public Health (HHS RFI Comment #1238). See also Jackson Health System (HHS RFI Comment #467) (‘‘The acknowledgment procedure takes less than one 256 National E:\FR\FM\17AUR2.SGM 17AUR2 Federal Register / Vol. 85, No. 159 / Monday, August 17, 2020 / Rules and Regulations correct that the SNPRM’s estimated financial burden for the Confirmation of Prescription Release was higher than that estimated for the Signed Acknowledgment, that was primarily due to an increase in the average hourly wages for prescribers and staff.264 In terms of time required for prescribers and their staff to comply, the SNPRM burden from the confirmation proposal was 13% less than that of the NPRM’s signed-acknowledgment proposal.265 The estimated burden of this modified Final Rule is also higher than the Signed Acknowledgment proposal, but a large part of the increase is due to higher wages and a substantial rise in the number of estimated contact lens wearers since publication of the NPRM.266 Furthermore, while the Final Rule’s estimated financial burden for the Confirmation of Prescription Release requirement of $20,428,750, is not insignificant, it amounts to approximately just $342 in increased administrative costs per eye care provider.267 In addition, while not every prescriber will be able to use option (D) minute.’’); UnityPoint Health (HHS RFI Comment #1122) (costs are relatively low, average of 60 seconds to explain NPP and obtain patient’s signature); UC Health (HHS RFI Comment #1155) (time spent to explain and obtain each signed acknowledgment is 40 seconds per patient); Missouri Hospital Association (HHS RFI Comment #1175); American Alliance of Orthopaedic Executives (HHS RFI Comment #1183). Other commenters to the HHS proposal disagreed, stating that the NPP signed acknowledgment requirement was an unnecessary burden, although much of their criticism was directed at the NPP itself rather than the acknowledgment. See, e.g., American Physical Therapy Association (HHS RFI Comment #601) (‘‘Providers currently undertake reasonable efforts to obtain the patient’s signature, and in most instances the patients ignore the language when signing the document.’’); Highmark Health (HHS RFI Comment #1124) (‘‘The effort to comply with this requirement is disproportionately onerous visa`-vis the general lack of attention individuals afford the NPP.’’). 264 SNPRM, 84 FR at 24693–94. 265 SNPRM, 84 FR at 24693–94. 266 See Section XI, infra. 267 This is based on an estimate from Wallace Lovejoy, a consultant for the National Association of Optometrists and Opticians, that there are approximately 43,000 optometrists and 16,700 ophthalmologists in the U.S. CLR Panel I Tr., supra note 100, at 6. Estimates vary as to the total number of eye care providers and contact lens prescribers in the United States, making it difficult to precisely calculate the burden on a per-provider or perprescriber basis. The investment firm Harris Williams & Co., for instance, put the estimate at 46,000 optometrists and 18,000 ophthalmologists. Harris Williams & Co., Vision Industry Update, at 2 (Mar. 2017) https://www.harriswilliams.com/ system/files/industry_update/vision_industry_ update_hcls_0.pdf. Meanwhile, the U.S. Bureau of Labor Statistics estimates there are 42,100 optometrists in the U.S., but does not provide an estimate for the number of ophthalmologists. https://www.bls.gov/ooh/healthcare/ optometrists.htm#tab-1. It must be noted, however, that not all optometrists and ophthalmologists prescribe contact lenses. VerDate Sep<11>2014 20:17 Aug 14, 2020 Jkt 250001 to deliver a prescription electronically, the Commission is confident that this option will still reduce the burden for many, especially as more prescribers move toward electronic recordkeeping. 8. Comments About the Exemption for Prescribers Who Do Not Have a Direct or Indirect Financial Interest in the Sale of Contact Lenses In the SNPRM, the Commission proposed an exemption from the Confirmation of Prescription Release requirement for prescribers who do not have a direct or indirect financial interest in the sale of contact lenses, including, but not limited to, though an association, affiliation, or co-location with a contact lens seller.268 The purpose of the proposed exemption was to reduce the burden on prescribers who do not sell lenses, and therefore, have no incentive to withhold prescriptions. The failure of the prescriber to provide the prescription under such circumstances would provide no benefit to the prescriber while likely alienating the patient. In fact, there is a strong incentive to provide patients with their prescriptions, since that is the only way they would be able to obtain contact lenses. At least one commenter voiced support for the exemption,269 but some were critical of the proposal.270 Some commenters suggested removing it in order to ‘‘future proof’’ the prescriptionrelease process in light of new and evolving business models—and intermingled financial interests— between prescribers and contact lens sellers.271 According to one commenter, the exception for those without a financial interest is ‘‘intentionally vague and leaves the barn door open for interpretation and abuse.’’ 272 The AOA also objected to the underlying premise that prescribers might consider their own interests above those of their patients.273 The Commission recognizes these concerns, but believes there is a significant benefit in more narrowly targeting only those with an incentive to 268 SNPRM, 84 FR at 24698. Reports (SNPRM Comment #133) (‘‘Although getting and keeping a record of the patient confirmation will not pose any significant burden, by definition these prescribers would seem not to pose any risk of conflict of interest in releasing the prescription; indeed, they would have an inherent interest in releasing it.’’). 270 Contact Lens Institute (SNPRM Comment #79); Zerbinopoulos (SNPRM Comment #147); Johnson & Johnson Vision Care, Inc. (SNPRM Comment #151). 271 See Contact Lens Institute (SNPRM Comment #79); Johnson & Johnson Vision Care, Inc. (SNPRM Comment #151); Alcon (SNPRM Comment #117). 272 Zerbinopoulos (SNPRM Comment #147). 273 American Optometric Association (SNPRM Comment #96). 269 Consumer PO 00000 Frm 00021 Fmt 4701 Sfmt 4700 50687 withhold prescriptions, thereby further reducing the overall burden and avoiding unnecessarily impacting prescribers who are unlikely to violate the Rule. Moreover, the Commission believes that determination of whether a financial interest exists is feasible, and that prescribers are unlikely to arrange their financial interests and business structures solely to circumvent the Confirmation of Prescription Release requirement. The Commission also believes it has the investigative tools to examine whether there is a financial interest, should the need arise. And if the Commission determines upon later review that such financial manipulation is occurring to circumvent the Rule, the Commission can revisit whether to remove the exemption. D. Additional Discussion and Commission Determination Regarding the Confirmation of Prescription Release Proposal The Commission has carefully reviewed and analyzed the entire record developed with respect to the Confirmation of Prescription Release proposal. This record includes more than 8,000 comments submitted in response to its 2015 Request for Comment, 2016 NPRM, 2018 Contact Lens Workshop, and 2019 SNPRM, as well the original history and legislative record relating to enactment of the FCLCA and the Rule in 2004. The evidentiary record as set forth in the NPRM and the SNPRM, as well as the Commission’s enforcement and oversight experience, supports the view that compliance with the Rule’s automatic-prescription-release requirement is sub-optimal, and as a result, a substantial number of consumers—several million contact lens users every year—are not receiving their contact lens prescriptions as required by law. Many consumers are unaware they even have a right to receive them. Implementing a Confirmation of Prescription Release requirement will result in an increase in the number of patients in possession of their prescriptions; improved flexibility and choice for consumers; a reduced verification burden for prescribers and sellers; a reduced likelihood of medical errors associated with incorrect, invalid, and expired prescriptions; and a reduction in the number of attempts to verify with the wrong prescriber.274 The ultimate result will be improved competition in the market, more efficient contact lens sales, improved patient safety, and lower prices for consumers. Furthermore, the 274 SNPRM, E:\FR\FM\17AUR2.SGM 84 FR at 24681. 17AUR2 50688 Federal Register / Vol. 85, No. 159 / Monday, August 17, 2020 / Rules and Regulations requirement will increase the Commission’s ability to enforce and assess its Rule, and will accomplish this in a reasonable manner that takes into consideration the needs and burdens of prescribers and sellers. In response to commenters’ concerns, the Commission has made three modifications to the proposal put forth in the SNPRM. The Commission concurs with the suggestion that requiring prescribers to identify the specific method or methods they would use for electronic delivery of prescriptions will increase awareness and allow patients to make a more informed decision. The Commission will therefore define ‘‘Provide to the patient a copy’’ in the Final Rule to require that prescribers who choose to offer an electronic method of delivery identify the specific method or methods used. The Commission also believes that evidence of consumer consent to electronic delivery of a prescription will aid in enforcing the Rule, and thus in its Final Rule, the Commission is requiring that prescribers keep records or evidence of a patient’s affirmative consent to a digital copy for at least three years. Lastly, for instances where a consumer refuses to sign the confirmation, in the Final Rule, the Commission directs the prescriber to note the refusal and preserve this record as evidence of compliance. The Commission believes that the burden from these three changes will be minimal. III. Additional Requirements for Sellers Using Verification Calls Containing Automated Messages In response to the Commission’s NPRM, a number of commenters criticized the use of verification calls containing automated messages (‘‘automated telephone messages’’), which they often refer to as ‘‘robocalls,’’ 275 with some requesting an outright ban of these calls.276 The Act and the Rule dictate that sellers that do not have a contact lens prescription presented to them directly or by facsimile verify the prescription by ‘‘direct communication.’’ 277 That term, in the Act and Rule, is defined as ‘‘completed communication by telephone, facsimile, or electronic mail.’’ 278 The Commission has stated 275 See SNPRM, 16 FR at 24684 and n.270. SNPRM, 16 FR at 24685 and n.281. 277 15 U.S.C. 7603(a); 16 CFR 315.5(a)(2). 278 Specifically, the Act defines direct communication to ‘‘include’’ a completed communication via one of these three methods, 15 U.S.C. 7603(g), whereas the Rule defines ‘‘direct communication’’ to ‘‘mean’’ a completed 276 See VerDate Sep<11>2014 20:17 Aug 14, 2020 Jkt 250001 that the Act expressly permits telephone communication for verification and believes that it would be contrary to congressional intent to prohibit use of automated telephone calls for the purpose of prescription verification.279 In response to the SNPRM, commenters continued to express criticism of automated telephone messages 280 with some continuing to urge the Commission to ban them.281 The AOA indicated that issues surrounding automated telephone messages have increased in the past five years and that poor quality automated telephone messages are jeopardizing eye health and resulting in consumers wearing non-prescribed contact lenses. It reports an increase in the use of calls that are difficult to understand, do not include all of the necessary information to confirm the prescription, and create barriers for prescribers to communicate corrections.282 Johnson & Johnson Vision Care and individual prescribers believe that automated telephone messages can ultimately lead to patients receiving incorrect lenses and suffering adverse health outcomes.283 Other commenters, however, indicated that automated telephone messages were not problematic and should not be prohibited.284 Consumer Action stated that ‘‘automated call systems appear to be working in a majority of cases’’ and that prescribers should design more responsive systems for handling such requests.285 The NAOO commented that from its members’ perspective, there are ‘‘no communication via one of these three methods, 16 CFR 315.2, a distinction discussed below. 279 SNPRM, 16 FR at 24684. 280 Gilberg (SNPRM Comment #46); Armitage (SNPRM Comment #66); Contact Lens Institute (SNPRM Comment #79); American Optometric Association (SNPRM Comment #96); Health Care Alliance for Patient Safety (SNPRM Comment #128); CooperVision, Inc. (SNPRM Comment #130); Johnson & Johnson Vision Care, Inc. (SNPRM Comment #151). 281 Gilberg (SNPRM Comment #46); Armitage (SNPRM Comment #66); Contact Lens Institute (SNPRM Comment #79); Health Care Alliance for Patient Safety (SNPRM Comment #128); CooperVision, Inc. (SNPRM Comment #130); Johnson & Johnson Vision Care, Inc. (SNPRM Comment #151). 282 American Optometric Association (SNPRM Comment #96). 283 Reeder (SNPRM Comment #55) (automated calls and passive verification can result in approval for patients who have never been seen and can lead to injury); Armitage (SNPRM Comment #66) (no way to safely and accurately ensure that a patient’s prescription is correctly verified with a robocallbased system); Johnson & Johnson Vision Care, Inc. (SNPRM Comment #151). See also Alcon Vision, LLC (SNPRM Comment #117) (noting health and safety risks associated with robocalls). 284 Consumer Action (SNPRM Comment #101); National Association of Optometrists and Opticians (SNPRM Comment #129). 285 Consumer Action (SNPRM Comment #101). PO 00000 Frm 00022 Fmt 4701 Sfmt 4700 issues with the use of automated calls, which tend to be infrequent to any particular prescriber’s office’’ and that such calls are an efficient method of verification.286 A. The Congressional Record Does Not Support Prohibiting Automated Telephone Messages Commenters in favor of a ban on such calls argue that the Commission lacks evidence that Congress intended to include automated calls in the definition of ‘‘direct communication’’ 287 and should eliminate the use of this antiquated technology in favor of methods that provide written documentation and the possibility of greater oversight in the verification process.288 In support of a ban, commenters stated that the Act does not mention the use of automated telephone messages and that the Commission’s interpretation of such calls as a valid form of ‘‘direct communication’’ may be counter to testimony provided during hearings that occurred prior to the Act’s implementation.289 These commenters stated that ‘‘congressional members and the then CEO of a major online contact lens seller made statements critical of automated telephone verification, stating explicitly that fax or another verifiable method were the preferred prescription verification methods for contact lens prescriptions.’’ 290 A closer analysis of the congressional testimony reveals a question to the CEO of the contact lens seller about earlier testimony by the AOA mentioning problems with both automated calls and continuous faxes.291 The CEO’s 286 National Association of Optometrists and Opticians (SNPRM Comment #129); see also 1–800 CONTACTS (SNPRM Comment #135) (its records indicate that ‘‘on average, prescribers are asked to verify just one order from 1–800 a week’’). 287 Health Care Alliance for Patient Safety (SNPRM Comment #128); CooperVision, Inc. (SNPRM Comment #130); Johnson & Johnson Vision Care, Inc. (SNPRM Comment #151). 288 Health Care Alliance for Patient Safety (SNPRM Comment #128); CooperVision, Inc. (SNPRM Comment #130); Johnson & Johnson Vision Care, Inc. (SNPRM Comment #151). CLR Panel IV Tr., supra note 121, at 9 (request of Steinemann for written requests only and not ‘‘robocalls’’). 289 Health Care Alliance for Patient Safety (SNPRM Comment #128); Johnson & Johnson Vision Care, Inc. (SNPRM Comment #151). 290 Health Care Alliance for Patient Safety (SNPRM Comment #128); Johnson & Johnson Vision Care, Inc. (SNPRM Comment #151). 291 See ‘‘Fairness to Contact Lens Consumers Act: Hearing Before the Subcommittee on Commerce, Trade, and Consumer Protection of the House Committee on Energy and Commerce,’’ 108th Cong. 1 (Sept. 12, 2003) (Rep. Shimkus: ‘‘Mr. Coon [CEO of 1–800 CONTACTS], there have been some questions [raised in earlier hearing testimony from the AOA] about the techniques companies like yours use to verify orders for contact lens E:\FR\FM\17AUR2.SGM 17AUR2 Federal Register / Vol. 85, No. 159 / Monday, August 17, 2020 / Rules and Regulations response merely recognized that there had been criticism of automated calls, and stated that at that time the company preferred fax verifications because they were written.292 There is no other mention of issues with automated calls by congressional members or the CEO during that hearing.293 Instead, such testimony arguably shows that Congress had been made aware of the criticisms of automated calls and, if it had wished to do so, could have banned their use explicitly. Yet, Congress specifically included telephone as a valid form of direct communication. The hearing also evidences a recognition that telephone communications, unlike faxes, would not be written. As a result, reference to this testimony does not change the Commission’s view that automated telephone messages are a permissible form of direct communication. The Health Care Alliance for Patient Safety referred to automated telephone messages as antiquated technology,294 and stated that the Commission should ban such calls in favor of methods that provide verifiable written communication, including fax, emails, and electronic portals.295 Such documentation, according to the Alliance, will allow for greater oversight and a safer environment allowing prescription verification through clearer, more concise and accurate communication between the prescriber and the seller.296 As previously stated, prescriptions, and problems such as automated calls and continuous faxes inhibiting optometrists from verifying prescriptions. Could you just go through your procedures for me?’’). 292 Id. (In response to Rep. Shimkus’s request to go through the company’s procedures, Rep. Burr: Mr. Coon, how does 1–800 currently request doctor verification? Mr. Coon: Well, the best system that we have found works the best, which we do in a majority of our orders—and there has been criticism of phone automated systems and other things. The system that works the best is in writing by fax. We know that there is a confirmation that it was received. And that’s the system that we would recommend.’’). 293 The Commission is also unaware of any other on-the-record discussions about automated calls during congressional consideration of the FCLCA. 294 Health Care Alliance for Patient Safety (SNPRM Comment #128). 295 Health Care Alliance for Patient Safety (SNPRM Comment #128); CooperVision, Inc. (SNPRM Comment #130). The Commission declines to include portals as a method by which sellers can verify prescriptions. In considering the proposal, the Commission considered that the Act defines direct communication to include telephone, fax, or email. As stated in the 2004 SBP, Congress’s use of the term ‘‘includes’’ contemplates that additional methods of communication could develop that could be used in the verification process. 69 FR 40490. However, there is no evidence that prescribers and sellers are using, or are likely to use, portals in the verification process. 296 Health Care Alliance for Patient Safety (SNPRM Comment #128). The Contact Lens Institute criticized the Commission for failing to VerDate Sep<11>2014 20:17 Aug 14, 2020 Jkt 250001 Congress expressly permitted use of the telephone knowing that this method did not produce writings like the other delineated verification methods, facsimile and email, and thus, the Commission declines to prohibit the use of this medium for verification. B. Comments About, and Adoption of, Requirements Proposed in the SNPRM To Improve Quality of Automated Telephone Messages In the SNPRM, the Commission recognized that additional requirements for automated verification calls were necessary to relieve the burden on prescribers and reduce potential health risks to patients from incomplete or incomprehensible automated telephone messages. Specifically, the Commission noted that prescribers must be able to understand automated messages so they can, if necessary, respond to sellers to prevent improper sales.297 As a result, the Commission proposed, via an amendment to § 315.5, requirements for sellers to improve verification calls that use, in whole or in part, an automated message. For these calls, sellers must: (1) Record the entire call; (2) commence the call by identifying it as a request for prescription verification; (3) provide the information required by § 315.5(b) in a slow and deliberate manner and at a reasonably understandable volume; and (4) give the prescriber the option to repeat the information.298 Commenters were largely in favor of the Commission’s proposals to: (1) Commence the call by identifying it as a request for prescription verification; (2) provide the information required by § 315.5(b) in a slow and deliberate manner and at a reasonably understandable volume; 299 and (3) give the prescriber the option to repeat this information.300 Seller 1–800 address the fact that the information conveyed in a telephonic communication needs to be reduced to a writing by the prescriber’s office so it can be compared to patient records, a process that must in virtually all cases be conducted separately from the call itself. SNPRM Comment #79. It follows, according to CLI, that written requests are more efficient and effective communication tools for both sellers and prescribers. 297 SNPRM, 16 FR at 24685. 298 SNPRM, 16 FR at 24685. 299 The Commission notes that these criteria have always been part of the Rule, but it has determined that they should be expressly set forth in the Rule. See 81 FR 88540 (‘‘A request delivered by an automated telephone system does not comply with the Rule if it is not delivered in a volume and cadence that a reasonable person can understand.’’). 300 American Optometric Association (SNPRM Comment #96) (stating support for these requirements, but expressing concern they are coming too late); National Association of Optometrists & Opticians (SNPRM Comment #129); 1–800 CONTACTS (SNPRM Comment #135); Johnson & Johnson Vision Care, Inc. (SNPRM PO 00000 Frm 00023 Fmt 4701 Sfmt 4700 50689 CONTACTS indicated that its verification messages already comply with these proposed requirements, and the NAOO indicated that its members have not identified any significant burdens in complying with these requirements.301 CooperVision indicated that these proposals, along with some of the Commission’s other proposals, helped address some of the more troubling issues with automated messages.302 On the other hand, the Contact Lens Institute, comprised of the major contact lens manufacturers, indicated that the Commission’s proposed measures demonstrate the impossibility of assuring that automated messages provide effective communication of required information and a reliable basis for passive verification.303 For instance, it stated that the Commission’s requirements to commence the call by identifying it as a request for prescription verification and to give prescribers an option to repeat assumes that prescribers will have live staff available 24 hours a day and will not need to rely on recording devices.304 The Commission does not find these criticisms compelling. The Commission recommended these proposals with an awareness that sometimes prescribers’ offices take these calls live and, at other times, the calls are left on recording devices. An option to repeat the information is helpful if a person answers live. If not, the prescriber has the ability to replay the message from the recording device. Similarly, commencing the call by identifying it as a request for prescription verification should help ensure that the prescriber’s office is ready to take the relevant information down, both when answering live and when playing the message from a recording device. As a Comment #151) (expressing approval for these provisions should the Commission not prohibit these calls altogether). 301 National Association of Optometrists & Opticians (SNPRM Comment #129); 1–800 CONTACTS (SNPRM Comment #135). 302 CooperVision, Inc. (SNPRM Comment #130). 303 Contact Lens Institute (SNPRM Comment #79). Members of the Contact Lens Institute are Alcon Vision, Bausch + Lomb, CooperVision and Johnson & Johnson Vision Care. The Commission notes that the opinions expressed in the CLI’s comment do not always conform with the opinions of the manufacturers as expressed in their individually filed comments. 304 It also described the Commission’s requirement to deliver the message in a ‘‘slow and deliberate manner’’ and at a ‘‘reasonable volume’’ as so vague as to be potentially unenforceable. Contact Lens Institute (SNPRM Comment #79. The Commission disagrees with this assessment, finding that these conditions are met if, upon listening to a call, the required information is comprehensible to a reasonable person. E:\FR\FM\17AUR2.SGM 17AUR2 50690 Federal Register / Vol. 85, No. 159 / Monday, August 17, 2020 / Rules and Regulations result, the Commission is implementing these amendments in its Final Rule. C. The Commission’s Proposal Requiring Sellers To Record Automated Telephone Messages In the SNPRM, the Commission also requested comments on its proposed amendment to § 315.5 to require sellers who verify prescriptions through automated telephone verification messages to record the entire call.305 Some commenters opposed the proposal,306 while others supported it.307 1–800 CONTACTS opposed the recording requirement, stating that it would impose a costly burden on sellers, is unnecessary because the Commission lacks evidence of a systematic problem with automated calls, and would not facilitate enforcement or improve compliance.308 This seller also commented that the requirement combined with state wiretapping laws may cause sellers to switch to other, perhaps less-reliable verification methods.309 In favor of the proposal, the AOA indicated that the cost of compliance is justified given the widespread issues with robocalls that currently exist.310 In support of its position that the recording requirement is unnecessary, 1–800 CONTACTS pointed to the Commission’s statement in the SNPRM that it does not have empirical data showing the frequency of verification calls that contain incomplete or incomprehensible automated messages.311 The seller further commented that the number of sellers that use this particular technology is likely limited and the Commission can much more easily acquire the evidence necessary to investigate complaints and bring an enforcement action in appropriate circumstances.312 It stated 305 SNPRM, 84 FR at 24685. Lens Institute (SNPRM Comment #79); 1–800 CONTACTS (SNPRM Comment #135); Consumer Reports (Comment #133). 307 The Health Care Alliance for Patient Safety (SNPRM Comment #128), CooperVision, Inc. (SNPRM Comment #130), and Johnson & Johnson Vision Care, Inc. (SNPRM Comment #151), supported the recording requirement if the Commission did not ban automated telephone messages altogether. See also American Optometric Association (SNPRM Comment #96); National Association of Optometrists & Opticians (SNPRM Comment #129). 308 1–800 CONTACTS (SNPRM Comment #135). 309 Id. 310 American Optometric Association (SNPRM Comment #96). 311 1–800 CONTACTS (SNPRM Comment #135). 312 1–800 CONTACTS stated that the Commission lacked evidence about whether problems occur with automated calls of more than a limited number of sellers, and if it is a limited number of sellers, the Commission should consider education and enforcement efforts instead of rule changes. For 306 Contact VerDate Sep<11>2014 20:17 Aug 14, 2020 Jkt 250001 that ‘‘the same cost-benefit approach that justifies additional recordkeeping for prescription release, counsels against additional superfluous and costly regulation and in favor of targeted enforcement.’’ 313 Consumer Reports noted that it was not aware of noncompliance similar to that of prescribers’ failure to release prescriptions.314 The Commission lacks empirical data on this issue, as noted in the SNPRM.315 However, it is undisputed that automated telephone messages are a commonly used method of verification. Moreover, these calls impose a cost on prescribers, and there are potential health risks to patients from incomplete and incomprehensible automated telephone requests.316 In fact, many commenters have indicated problems with the quality of automated telephone messages.317 The AOA commented in response to the SNPRM that, in its survey of 629 doctors of optometry, 85% reported that automated calls for prescription verifications have increased in the past five years, and 88% indicated that the quality of such calls has decreased in the past five years.318 These commenters have exposed an issue for enforcement: Without a call recording,319 the Commission cannot reliably assess whether that call was compliant and further whether the seller has a pattern instance, the Commission could obtain the recording itself from prescribers who assert that they have received an invalid or incomprehensible verification call. Id. Although the Commission could obtain such recordings from prescribers, the information would not be complete. Without the ability to obtain recordings from the seller, the Commission would be unable to assess if the call the seller relied on was compliant, was noncompliant (violating the Rule) but an anomaly, or was part of a widespread use of problematic calls. Moreover, as to its point about the limited number of sellers making these calls, new contact lens sellers are routinely entering the market and the Commission needs to ensure it can enforce against them if it receives complaints. 313 1–800 CONTACTS (SNPRM Comment #135). 314 Consumer Reports (SNPRM Comment #133). 315 SNPRM, 84 FR at 24685. 316 Id. 317 NPRM, 81 FR at 88538 nn.152, 154, 155; SNPRM, 84 FR at 24684 n.270. See also CLR Panel IV Tr., supra note 121, at 8 (statement of David Cockrell that the office can’t understand many of the robocalls); id. at 8 (statement of Tim Steinemann that many robocalls are unintelligible or cut off). 318 American Optometric Association (SNPRM Comment #96). However, because the AOA did not provide the survey itself or the data from the survey, the Commission does not rely on it as more than anecdotal evidence. 319 The Commission has received numerous comments from prescribers indicating that they have received non-compliant messages, some of which were left on their answering machines, yet has received very few actual recordings of these messages from prescribers. PO 00000 Frm 00024 Fmt 4701 Sfmt 4700 of placing non-compliant calls (and selling after such calls). 1–800 CONTACTS commented that it is an unnecessary burden for sellers to record and retain copies of thousands of identical verification calls, the costs of which would exceed the benefits.320 Consumer Reports shared this sentiment and suggested that it would be more reasonable for the Commission to require sellers to retain a sample recording of the standard script, leaving blanks for prescription and patient details.321 The Commission believes that seeing a script of information relayed or a sample recording has limited utility. A script or a sample recording would not reveal whether the required information was transmitted for any particular automated telephone message or if, for instance, required information was transmitted before a representative or machine answered, after an answering machine cut off, when a prescriber’s office put the call on hold, or over hold music, in which case the call could not be lawfully used as a basis for the sale.322 Further, a script or sample recording would not permit the Commission to assess whether each call was delivered in a ‘‘slow and deliberate manner’’ and at a ‘‘reasonably understandable volume.’’ Without knowing this information, the Commission would be unable to determine conclusively whether any particular verification request was valid. Therefore, the Commission is not adopting this recommendation. 1–800 CONTACTS asserted that the requirement to record verification calls would not only impose additional regulatory burdens on sellers, but also expose sellers to legal risk.323 The seller argued that by recording telephone communications, sellers might risk violating two-party consent laws in the states that require all parties on the call to consent to recordings.324 After 320 1–800 CONTACTS (SNPRM Comment #135). Reports (SNPRM Comment #133). 322 One commenter requested a requirement for online sellers to maintain files of recordings of each verification attempt made by automated message for a period of no less than three years. Health Care Alliance for Patient Safety (SNPRM Comment #128). The Commission is only requiring sellers to maintain recordings of automated telephone calls that are the basis for the sale, and to maintain these recordings for three years. There is no need under the Rule for sellers to maintain recordings of unsuccessful verification attempts. 323 1–800 CONTACTS (SNPRM Comment #135). 324 Twelve states have such a requirement: California, Connecticut, Delaware, Florida, Illinois, Maryland, Massachusetts, Montana, Nevada, New Hampshire, Pennsylvania, and Washington. See Cal. Penal Code § 632(a), (c) (West 2019); Conn. Gen. Stat. § 52–570d(a) (West 2019); Del. Code Ann. tit. 11, § 2402(a), (c)(4) (West 2019); Fla. Stat. Ann. § 934.03(1), (3)(d) (West 2019); 720 Ill. Comp. Stat. Ann. 5/14–2(a) (West 2019); Md. Code. Ann., Cts. 321 Consumer E:\FR\FM\17AUR2.SGM 17AUR2 Federal Register / Vol. 85, No. 159 / Monday, August 17, 2020 / Rules and Regulations reviewing the relevant statutes and applicable case law, the Commission does not believe sellers risk conducting illegal calls by recording them.325 For instance, though the California penal code prohibits eavesdropping on or recording confidential communications without two-party consent, the code excludes from the definition of ‘‘confidential communication’’ any circumstances ‘‘in which the parties to the communication may reasonably expect that the communication may be overheard or recorded.’’ 326 The California Supreme Court has stressed that § 632 of the California penal code does not preclude parties from ever recording conversations, but rather prohibits parties from doing so ‘‘secretly’’ or ‘‘surreptitiously,’’ declaring that a business would not violate the state’s wiretapping laws if it advised parties to a communication of its intent to record the call at the outset of the conversation.327 Similarly, in & Jud. Proc. § 10–402(a), (c)(3) (West 2019); Mass. Gen. Laws Ann. ch. 272, § 99(C) (West 2019); Mont. Code Ann. § 45–8–213(1)(c), (2)(a)(iii) (West 2019); Nev. Rev. Stat. Ann. § 200.620 (West 2019); N.H. Rev. Stat. Ann. § 570–A:2 (2019); 18 Pa. Stat. and Cons. Stat. Ann. § 5703, 5704(4) (West 2019); Wash. Rev. Code Ann. § 9.73.030(1), (3) (West 2019). It is also possible that Michigan has a two-party consent law, although interpretations of the law differ, and the issue has not been firmly resolved. See Mich. Comp. Laws Ann. § 750.539c (‘‘Any person . . . who willfully uses any device to eavesdrop . . . without the consent of all parties thereto . . . is guilty of a felony). Compare AFT Mich. v. Project Veritas, 378 F. Supp. 3d 614, 620 (E.D. Mich. 2019) (finding statute prohibits participants from recording private discourse of any other person involved in the conversation unless all persons consent); with Sullivan v. Gray, 324 N.W.2d 58, 60 (Mich. Ct. App. 1982) (finding statute does not require two-party consent because it only prohibits eavesdropping, which is defined as recording the ‘‘private discourse of others.’’ (emphasis added)). 325 Of course, the Commission cannot predict precisely how different jurisdictions will apply state laws. However, the Commission is unaware of a party ever being held liable for violating two-party consent requirements in a situation where the call contained a disclosure message at its onset. The Commission further notes that jurisdictions take different approaches to deciding which state law applies for interstate or multi-state phone calls. See, e.g., Ditech Fin. LLC v. Buckles, 401 P.3d 215 (Nev. 2017). Therefore, when recording calls with prescribers located in other states, sellers should abide by the more stringent law that applies or obtain the consent of all parties to the communication. As the Commission stated in the SNPRM, 84 FR at 24685 n.288, sellers are responsible for determining compliance with state law taping requirements. 326 Cal. Penal Code § 632(a), (c). 327 Kearney v. Salomon Smith Barney, Inc., 137 P.3d 914, 930 (Cal. 2006); see also Hataishi v. First Am. Home Buyers Prot. Corp., 168 Cal. Rptr. 3d 262, 271 (Cal. Ct. App. 2014) (stating California consumers are accustomed to receiving notice of a business’s intention to record a call); CS Wang & Assoc. v. Wells Fargo Bank, N.A., 305 F. Supp. 3d 864, 885 (N.D. Ill. 2018) (Under the California Invasion of Privacy Act, ‘‘the baseline assumption VerDate Sep<11>2014 20:17 Aug 14, 2020 Jkt 250001 Massachusetts, a person cannot willfully intercept any wire or oral communication, with ‘‘interception’’ defined in the statute as secretly hearing, secretly recording, or aiding another to do so without the parties’ consent.328 The Massachusetts Supreme Court has ruled that a system that expressly notifies the parties that the call will be recorded does not commit an interception because the system does not record the conversation in secrecy.329 Thus, in California and Massachusetts, sellers who provide a standard notification at the beginning of the call, which has become customary in many business communications, are unlikely to risk violating state wiretapping laws. Moreover, after reviewing the plain language of other state statutes requiring two-party consent and case law, the Commission concludes that if sellers express their intentions to record the conversation at the outset of each call, sellers located in or contacting prescribers in two-party consent states will not risk violating a state’s respective wiretapping law. Announcements at the outset of the calls would prevent sellers from committing violations because prescribers can either provide or withhold consent. For instance, under Florida’s and Maryland’s statutes,330 as long as a party has received notice of an intent to record, the notified party can expressly or impliedly consent by remaining on the line.331 1–800 in situations where the recorded party does not initiate the call, does not have a prior relationship with the caller, and does not receive a warning at the outset of the call, is that it is reasonable for a party to expect that its conversation is not being recorded.’’) (emphasis added). 328 See Mass. Gen. Laws Ann. ch. 272, § 99(B)(4), (C)(1). 329 See Commonwealth v. Boyarsky, 897 N.E.2d 574, 579 (Mass. 2008) (finding ‘‘there was no interception because there was no secret recording, and the inquiry is at an end’’); see also Marquis v. Google, Inc., No. SUCV2011–02808–BLS1, 2014 WL 4180400, at *12 (Mass. Super. Ct. July 27, 2014) (‘‘The core of the statute is . . . the prevention of the secret interception of wire communications . . . . In consequence, if a recording is ‘not made secretly,’ it does ‘not constitute an ‘interception’’ and there has been no violation of the statute.’’). 330 Fla. Stat. Ann. § 934.03(2)(d); Md. Code. Ann., Cts. & Jud. Proc. § 10–402(a), (c)(3). 331 See Levin v. Red Rock Fin. Servs., LLC, No. 70006, 2017 WL 519414, at *1 (Nev. Ct. App. Jan. 30, 2017) (agreeing that summary judgment applying Nevada and Florida law had been properly granted because appellant ‘‘necessarily heard the pre-recorded announcement during every phone call . . . and consequently gave implied consent to be recorded during each call by continuing with the call’’) (emphasis added); Briddell v. State, No. 1220, 2016 WL 4698158, at *3–4 (Md. Ct. Spec. App. Sept. 7, 2016) (finding plaintiff ‘‘was not forced to communicate . . . nor continue with the phone conversation after being notified that it would be recorded and monitored’’ and consented to PO 00000 Frm 00025 Fmt 4701 Sfmt 4700 50691 CONTACTS notes that a prescriber could effectively reject a valid method of verification—verification by telephone—by declining to give consent.332 In the event that a prescriber declines to consent to a recorded call containing an automated telephone verification message, sellers may make verification requests via email, live call, or fax. Sellers may also elect to leave automated telephone messages after hours on prescribers’ answering machines. Such calls would not implicate wiretapping laws since the prescriber is not on the line.333 Commenters also opined on whether the Commission should extend its recording requirement to verification calls that do not involve automated messages, i.e., live calls. 1–800 CONTACTS suggested that the requirement to record calls including automated messages should apply equally to live calls because sellers might otherwise have an incentive to outsource live verification calls to inexpensive call centers that can ‘‘game the system’’ by making it difficult for prescribers to understand or respond to live verification requests.334 On the other hand, the NAOO, without explanation, supported the Commission’s recording requirement for automated calls as long as the Commission does not expand the requirement to apply to live calls.335 For several reasons, the Commission declines to compel sellers to record live calls. Foremost, during live calls, a prescriber can ask a seller to repeat the message or to clarify unintelligible information, and can look up a patient’s file in real time to verify the recording ‘‘by continuing to speak after the [warning] messaged [had] played.’’) (emphasis added). See also Wash. Rev. Code Ann. § 9.73.030(3) (‘‘[C]onsent shall be considered obtained whenever one party has announced to all other parties engaged in the communication or conversation, in any reasonably effective manner, that such communication or conversation is about to be recorded or transmitted.’’). 332 1–800 CONTACTS (SNPRM Comment #135). 333 Some prescribers commenting on the Rule have expressed concern that verification calls placed during non-business hours violate the Rule. See NPRM, 81 FR at 88544 and n.232. Sellers who leave compliant verification messages after hours do not violate the Rule as long as they wait the required eight business hours before selling lenses (assuming there is no communication from the prescriber invalidating or approving the message before that time period concludes). 334 1–800 CONTACTS (SNPRM Comment #135). The seller also pointed to the Commission’s statement in the SNPRM that it does not know that a phone call with an automated message is necessarily less reliable than one with a live person. Id. (citing SNPRM, 84 FR at 24685). 335 National Association of Optometrists and Opticians (SNPRM Comment #129). E:\FR\FM\17AUR2.SGM 17AUR2 50692 Federal Register / Vol. 85, No. 159 / Monday, August 17, 2020 / Rules and Regulations prescription.336 In this setting, a seller is likely to limit any bad conduct. While bad actors could speak incoherently, exclude key information, or refuse to repeat the message when asked, the Commission has not received or seen evidence of such behavior, and the record does not reflect any other widespread issue involving the quality of live calls. Finally, the Commission considered mass merchandisers that verify prescriptions largely or exclusively by calling prescribers to obtain verification via a live call when a customer purchases lenses at the store. Because these sellers use their phone lines for a multitude of purposes unrelated to prescription verification, such as taking consumer orders or checking inventory for a consumer, it would be difficult to implement a recording system in compliance with this Rule. However, should the Commission receive complaints that show an issue with sellers’ conduct on live calls, the Commission will reassess the need to require sellers to record live verification calls. D. The Final Rule Does Not Adopt Commenters’ Additional Recommendations Regarding Automated Telephone Messages A number of additional recommendations were suggested by commenters regarding calls that contain, in full or in part, automated messages.337 The Health Care Alliance for Patient Safety and Johnson & Johnson Vision Care requested that the FTC review and approve a transcript of sellers’ automated telephone messages before sellers are permitted to use calls containing such messages.338 The Contact Lens Institute urged the Commission to require sellers to follow a ‘‘specific script that includes standardized terms, a standardized order of presenting the required information, and a standardized pace,’’ 339 and to require sellers to document that they only use means of transmission that have been tested and shown to result in receipt of clear and 336 CLR Panel IV Tr., supra note 121, at 15 (statement of David Cockrell referring to how live calls provide opportunity for two-way conversation). 337 The Contact Lens Institute (SNPRM Comment #79), Health Care Alliance for Patient Safety (SNPRM Comment #128), and Johnson & Johnson Vision Care, Inc. (SNPRM Comment #151) proposed these additional requirements in the event that the Commission declined to prohibit use of verification via automated telephone messages. 338 Health Care Alliance for Patient Safety (SNPRM Comment #128); Johnson & Johnson Vision Care, Inc. (SNPRM Comment #151). 339 Contact Lens Institute (SNPRM Comment #79). Alcon Vision made a similar recommendation. See SNPRM Comment #117. VerDate Sep<11>2014 20:17 Aug 14, 2020 Jkt 250001 unambiguous information at the receiving end of the call.340 The Commission is not implementing these recommendations. The information that sellers need to include to make a valid verification request is clearly delineated in § 315.5(b), (d)(2), and (d)(4) of the Final Rule.341 The Commission does not believe that reviewing and approving a transcript would be an effective use of its resources because it is the call itself that ultimately determines whether there is a valid verification request. Further, while there is some utility in providing a script so prescribers receive the information in a predictable manner, the Commission is not convinced that there is only one effective way for a seller to comply with the Rule, or that this requirement is necessary.342 The Rule already indicates what information needs to be included in the message, and the additional requirements the Commission is implementing should make it easier for prescribers to obtain the information. Should seller verification messages be deficient in providing all the required information, prescribers should notify the seller. Moreover, assuming a seller is complying with the Rule by recording calls that contain these messages, the Commission can ascertain whether the call included all the required information (and whether the seller ultimately sold lenses pursuant to an invalid verification call). A review of the recording will provide better information on compliance than would knowing that the seller used a transcript—including an FTC-approved transcript—or a means of transmission that the seller has tested and documented as effective. The Health Care Alliance for Patient Safety and Johnson & Johnson Vision Care also requested a requirement that online sellers confirm that automated calls are answered by a person at the prescriber’s office, as opposed to a recording device, before initiating an 340 Contact Lens Institute (SNPRM Comment #79). review of a script would not reveal whether the seller was complying with Section 315.5(d)(3) and (4) of the Final Rule (the requirements as to cadence, volume, and the ability to repeat the information). 342 Similarly, 1–800 CONTACTS requested a requirement that a pre-recorded message be limited to providing only the information required under the Rule and not include extraneous information that could make the call confusing or more burdensome. SNPRM Comment #135. Although the Commission cautions sellers against including extraneous information, it has not seen evidence of a widespread use of calls including such information and thus is not implementing this recommendation. 341 Commission PO 00000 Frm 00026 Fmt 4701 Sfmt 4700 automated message.343 In essence, they are asking for a requirement that all verification calls be placed during a prescriber’s business hours, presumably the time when prescribers’ phone lines are staffed.344 These commenters also requested that the Commission require online sellers who use automated telephone messages to provide, for prescriber’s use, a centralized call-back number and have the call-back number staffed by a person from the seller.345 In the same vein, CooperVision commented that the Commission should require sellers to provide the means for the prescriber to disrupt a verification call that uses, in whole or in part, an automated message, in order to connect with a person at the seller to provide correct information.346 Without this requirement, according to CooperVision, eye care professionals are limited in their ability to correct information that is important for the patient’s eye health or that could prevent improper substitution of lenses.347 The Rule does not require sellers’ communication via telephone, email, or fax to occur during business hours. The Rule requires, instead, that sellers wait eight business hours after a valid verification call to sell the lenses. Moreover, the Rule already requires the seller to provide the name of a contact person at the seller’s company, including facsimile and telephone numbers.348 Should a prescriber inform the seller within eight business hours that the prescription was inaccurate, expired, or otherwise invalid, the seller cannot lawfully sell those contact lenses. If a prescriber informs a seller that the verification request itself was non-compliant, the seller is on notice that it may need to provide another verification request prior to selling the lenses. The prescriber need not relay that information to a person at the seller, whether during the verification 343 Health Care Alliance for Patient Safety (SNPRM Comment #128); Johnson & Johnson Vision Care, Inc. (SNPRM Comment #151). 344 It is not clear that this option would be desired by prescribers, some of whom have indicated that they do not have time during business hours to respond to these requests or that such calls tie up their phone lines. See NPRM, 81 FR 88539 n.158. 345 Id.; see also CLR Panel IV Tr., supra note 121, at 10 (statement of David Cockrell that the office needs to be able to contact the seller immediately and it ‘‘can’t even leave a message’’). 346 CooperVision, Inc. (SNPRM Comment #130). 347 CooperVision also stated confusion as to whether the Commission’s requirement for sellers to provide an option to repeat the verification information included a requirement for sellers to provide the means for the prescriber to immediately disrupt an automatic call in order to connect with a live person. SNPRM Comment #130. It does not. 348 16 CFR 315.5(b)(6). E:\FR\FM\17AUR2.SGM 17AUR2 Federal Register / Vol. 85, No. 159 / Monday, August 17, 2020 / Rules and Regulations call or at other times.349 Instead, it is sufficient notice for a prescriber to leave a voicemail, or send a facsimile, that provides the seller with enough information so as to identify the consumer or order being called about (a consumer name, reference number, or even the prescriber’s name with the date of the verification call could be adequate), and that the prescription is inaccurate, expired, or otherwise invalid.350 In addition, requiring sellers to reach a person (and not a machine) at the prescriber’s office, or to provide a call-back number that is answered by a person (and not a machine), would mean either that sellers would need to have agents available at all times, or else only contact prescribers during business hours for both the seller and prescriber, which may be difficult if they are located in different time zones. Requiring that sellers have someone available at all times to respond to prescriber inquiries would also be costly for sellers, with no readily apparent countervailing benefit. For these reasons, the Commission declines to implement a requirement that sellers ensure that automated telephone messages are answered by a person at the prescriber’s office, as opposed to a recording device, or that prescribers be able to reach a live person at the seller.351 The Health Care Alliance for Patient Safety and Johnson & Johnson Vision Care further requested a requirement that online sellers verify that they are making verification calls to the office of a legitimate eye care professional. The Commission is aware of allegations of sellers making verification calls to numbers clearly not affiliated with eye care prescribers. The Rule requires a seller to sell contact lenses in accordance with a contact lens 349 If a seller does not maintain a person to answer the phone number it provides, it must provide an opportunity for the prescriber to leave a message. A seller that does not check its voicemail runs the risk of selling lenses after a prescriber has timely invalidated or corrected the prescription, thereby violating the Rule. 350 Final Rule § 315.5(e) requires the prescriber to specify the basis for the inaccuracy or invalidity of the prescription, and if the prescription is inaccurate, the prescriber shall correct it. Final Rule 16 CFR 315.5(e). Even if the prescriber violates the Rule by failing to specify the basis for the inaccuracy or invalidity, or by failing to correct the prescription, the seller is still prohibited from selling if a prescriber informs the seller that the prescription is inaccurate, expired, or otherwise invalid within the eight-business-hour time period. 351 The Commission notes that some sellers have agents who stay on the line to ensure that, before commencing the automated message, an individual at the prescriber’s office has answered the phone, or that the answering machine has picked up before leaving the message. Such a practice helps ensure that the beginning of the message is not cutoff or played over hold music. VerDate Sep<11>2014 20:17 Aug 14, 2020 Jkt 250001 prescription for the patient that, if not presented to the seller, is verified by direct communication.352 Of course, for prescription verification to be meaningful, that verification must go to the consumer’s eye care prescriber. Although the seller does not know whether the prescriber contact information provided by the consumer is that of the consumer’s own eye care prescriber, to ensure that its verification request complies with the Rule, it is incumbent upon the seller to ascertain whether the number provided by the consumer is for an eye care prescriber. If it is apparent from the consumer’s entry itself,353 or from the seller’s research on the internet or otherwise, that the number provided is not affiliated with a prescriber, or if it cannot be determined whether it is, the seller should either reach out to the consumer to obtain better contact information or cancel the order. Calls to numbers clearly not associated with eye care prescribers are not compliant verification requests, and any sales made pursuant to such requests violate the Rule. The Commission intends for this notice to provide sufficient guidance for sellers and does not see a need to amend the Rule to address this issue. The Commission is implementing the recommendations outlined in the SNPRM for automated telephone messages in the Final Rule, without modification. CooperVision requested guidance on how the Commission intends to interpret and enforce these provisions.354 This notice should provide sellers with information to assist them in complying with the new rule requirements. The Commission also plans to publish education on these Final Rule requirements. As to enforcement, should the Commission receive complaints about the quality of automated calls, it can request that the seller produce the recording of the call in question. IV. Prescribers’ Selection of Communication Mechanism 352 16 PO 00000 Frm 00027 Fmt 4701 Sfmt 4700 81 FR at 88542. (NPRM Comment #179); Krattli (NPRM Comment #1976). 357 Johnson & Johnson Vision Care, Inc. (NPRM Comment #4327). The manufacturer also requested that sellers be required to provide an option, as part of a verification message, for the prescriber’s office to elect an alternate means to receive the request, and an alternate time frame after which the window to respond to verification requests must be completed. Johnson & Johnson Vision Care, Inc. (SNPRM Comment #151). 358 American Optometric Association (NPRM Comment #3830). 359 Id. 360 NPRM, 81 FR at 88542. Similarly, the seller should consider whether to accommodate prescribers’ requests to contact them during specified time-periods (i.e., business hours, or after business hours). 356 O’Daniel CFR 315.5(a). instance, sellers should not verify a prescription when the consumer identifies the prescriber as ‘‘Santa Claus.’’ Similarly, sellers should not place verification calls to phone numbers that consumers list as the prescriber phone number when that phone number is the same number a consumer lists as her own contact number. 354 CooperVision, Inc. (SNPRM Comment #130). 353 For that sellers are able to use any or all of the three delineated methods, telephone, facsimile, or electronic mail.355 In response, prescribers continued to request that they be able to select the method of communication used to submit verification requests from among telephone, facsimile, or electronic mail.356 Johnson & Johnson Vision Care commented that it wished to work with the Commission and Congress to improve prescriber-seller communications, such as by allowing a prescriber to select her preferred method for verification requests.357 The AOA commented that the Commission took a step in the right direction when it suggested that sellers evaluate whether honoring prescriber preferences with regard to communication method would increase the speed and efficiency of the verification process.358 It nevertheless urged the Commission to provide more instruction to sellers, and to outline the verification-related complaints that the Commission has received, so prescribers and sellers can work together to ensure patients receive the contact lenses that were prescribed.359 The Commission reiterates its suggestion that sellers and prescribers work together to ensure that patients receive their prescribed lenses. As stated in the NPRM, the Commission requests sellers to consider whether the speed and efficiency of the verification process would be increased by accommodating prescribers’ requests to contact them with verification requests via a certain method.360 However, because the Act defines ‘‘direct communication’’ to include three different communication mechanisms that sellers may use—telephone, facsimile, or electronic mail—the Act does not permit prescribers to limit the communication mechanisms sellers may 355 NPRM, In the NPRM, the Commission pointed out that the Act does not permit prescribers to limit the communication mechanism sellers may use to submit requests for verifying prescriptions, and 50693 E:\FR\FM\17AUR2.SGM 17AUR2 50694 Federal Register / Vol. 85, No. 159 / Monday, August 17, 2020 / Rules and Regulations use to submit verification requests.361 The Commission is therefore not making any changes to the Rule in this area. V. Miscellaneous Passive Verification Issues A. Active Verification Is Not Required In the NPRM, the Commission declined to propose replacing passive verification with active verification, despite concerns from many commenters.362 Commenters expressed concern that the passive verification system could easily be manipulated, for example, by a patient who provides false or incorrect prescriber information to a seller, or by a seller who sends the same verification request over and over again in the hope that the prescriber will fail to reply and deny one of them.363 However, because Congress decided to include a passive verification system in the Act, and the issues commenters raised were identical to those raised during the initial 2004 rulemaking, the Commission chose not to revisit the decision to include passive verification.364 Following the NPRM, many commenters reiterated the same concerns with respect to passive verification, including that sellers could abuse the system or that consumers might obtain lenses without a prescription or receive incorrect lenses, and they advocated for a switch to active verification.365 Because these concerns are similar to those raised during the initial rulemaking in 2004 and because Congress mandated passive verification in the FCLCA, the Commission again declines to modify the Rule to require active verification.366 361 See 15 U.S.C. 7603(g). The Commission came to the same conclusion in its initial rulemaking. 69 FR at 40497. The Commission recognizes that in practice, sellers’ options may be limited. For instance, should a prescriber’s office not have facsimile, a seller would be unable to complete a verification request via fax. 362 NPRM, 81 FR at 88543. 363 Id. 364 Id. 365 See, e.g., Golden (WS Comment #1353); Weidel (WS Comment #2333); Gray (WS Comment #2730); Audia (NPRM Comment #698); Bazan (NPRM Comment #706); Dewart (NPRM Comment #897); Nixon (NPRM Comment #1510); Weissman (NPRM Comment #1676); Goshe (NPRM Comment #2597); Fritsch (NPRM Comment #2683); Garr (NPRM Comment #2858); Phan (NPRM Comment #3350). Some commenters continued to support passive verification. See 1–800 CONTACTS (WS Comment #3207); National Association of Optometrist and Opticians (WS Comment #3208) (‘‘No changes are needed to the passive verification system.’’). 366 The Commission also notes that nothing in the Rule prevents active verification by a seller. If it prefers, a seller can choose to actively verify a prescription. CLR Panel IV Tr., supra note 121, at 5 (statement of Jennifer Sommer) (stating that VerDate Sep<11>2014 20:17 Aug 14, 2020 Jkt 250001 However, the Commission has made several changes to the Rule aimed at improving the quality of automated verification calls, which will allow prescribers to more effectively prevent the sale of contact lenses when the prescription is inaccurate, expired, or otherwise invalid.367 The Commission has also improved patients’ access to their prescriptions by implementing requirements enabling patients to obtain electronic copies and additional copies of their prescriptions, and to present their prescriptions directly to sellers, which should reduce the need for passive verification requests.368 The Commission recognizes that some sellers may engage in verification practices that violate the Rule’s requirements 369 and, for that reason, will continue to monitor the marketplace and investigate potential violations when appropriate. B. Concerns About Patient Manipulation In the NPRM, the Commission declined to propose any changes to the Rule to address concerns that patients were manipulating the passive verification system by deliberately providing inaccurate prescriber information to the seller.370 The Commission noted that if prescribers received a verification request for an individual who was not their patient, they have the ability to respond that such request is invalid, which would prevent the sale under § 315.5 of the Rule. Some commenters provided anecdotal evidence of instances where consumers have intentionally provided inaccurate information, but the Commission did not have any empirical evidence showing the frequency of this problem.371 Moreover, Congress was aware that passive verification was not a foolproof method to prevent verification of invalid prescriptions, but nonetheless mandated passive verification to balance the interests of consumer health and prescription portability. In response to the NPRM, commenters continued to express concerns with patients being able to obtain contact lenses without a valid prescription, especially with only eight business hours to respond to a verification request, and with the potential health Walmart often actively verifies prescriptions by calling the prescriber’s office). 367 See Section III, supra; 16 CFR 315.5(c)(2), (d). 368 See Section II.C.5, supra, and Sections VII and VIII, infra. 369 16 CFR 315.5(a)–(d). 370 NPRM, 81 FR at 88543. 371 Id. PO 00000 Frm 00028 Fmt 4701 Sfmt 4700 consequences.372 To address concerns with patient manipulation of passive verification, commenters advocated using an active verification system, requiring that a prescription be presented, changing the method used to send verification requests, or increasing the amount of time for a prescriber to respond.373 The Commission recognizes prescribers’ concerns about the potential health effects on patients who wear nonprescribed lenses. However, as noted in the NPRM, Congress chose the passive verification framework as a way to balance consumer health and prescription portability.374 Congress also allowed verifications by direct communication, which it defined as including telephone, facsimile, and electronic mail.375 Congress was aware that passive verification was not a perfect method to prevent patients from deliberately providing incorrect information.376 The Commission does not have any evidence, aside from anecdotal reports, showing the extent to which patients are intentionally providing incorrect information to a seller in order to obtain contact lenses. Thus, the Commission does not believe that significant modifications to the Rule to address the concern about consumers submitting inaccurate prescriber information are warranted. However, in its Final Rule, the Commission has implemented several changes to improve verification calls that use an automated telephone system, which will make it easier for prescribers to deny requests based on inaccurate prescriber information. These changes 372 See, e.g., Johnson & Johnson Vision Care, Inc. (SNPRM Comment #151); Lem (WS Comment #470); Dillehay (WS Comment #822); Baird (WS Comment #1918); Hemler (WS Comment #2312); Patel (WS Comment #2691); Gray (WS Comment #2730); Bottjer (WS Comment #3378); Tuttle (NPRM Comment #161); Gilberg (NPRM Comment #198); Moy (NPRM Comment #382); Engler (NPRM Comment #453); Francis (NPRM Comment #588); Stott (NPRM Comment #687); Kempf (NPRM Comment #915); McPherson (NPRM Comment #3397); Schlater (NPRM Comment #3504); Bengoa (NPRM Comment #3600); Jackson (NPRM Comment #3736). 373 See, e.g., Contact Lens Association of Ophthalmologists, Inc. (WS Comment #770); Northsight Vision Care Center (WS Comment #1196); Golden (WS Comment #1353); BegenyMahan (WS Comment #1702) (requesting that the eight-business-hour period be changed to forty-eight hours); Kirkconnell (WS Comment #1754) (requesting two business days to respond and stating that requests should be faxed); American Society of Cataract and Refractive Surgery (WS Comment #3142) (advocating for extending the eight-business-hour time-period for passive verification to five business days); Bazan (NPRM Comment #706); Garr (NPRM Comment #2858); Greitzer (NPRM Comment #3388). 374 NPRM, 81 FR at 88543. 375 15 U.S.C. 7603. 376 NPRM, 81 FR at 88543. E:\FR\FM\17AUR2.SGM 17AUR2 Federal Register / Vol. 85, No. 159 / Monday, August 17, 2020 / Rules and Regulations include identifying at the start of the call that it is a prescription verification request, delivering the information in a slow and deliberate manner and at a reasonably understandable volume, and giving the prescriber the option to repeat the call.377 Prescribers will be better able to identify the relevant patient information and inform sellers during the eight-business-hour period that the request is invalid.378 The Commission will also continue to monitor the marketplace, investigate any sellers encouraging patients to provide false information, and continue its consumer education efforts communicating the importance of having a prescription when purchasing contact lenses.379 C. Eight-Business-Hour Time Frame Is Appropriate In the NPRM, the Commission considered commenters’ concerns that the eight-business-hour time frame was too short and that verification calls were being placed outside of business hours or when the prescriber’s office was closed.380 The Commission declined to lengthen or otherwise modify the eightbusiness-hour time frame during which a prescriber must respond to a verification request.381 The Commission did not find sufficient evidence quantifying how the eight-business-hour time frame imposed a significant burden or showing that a significant number of prescribers were unable to respond to the verification requests within the allotted time. The Commission further noted that there have been no compelling changes to the marketplace since the Rule was implemented in 2004 that would justify extending the period beyond eight business hours. In response to the NPRM, some commenters indicated that eight business hours constituted a sufficient period for a prescriber to respond to a verification request.382 However, other 377 See Section III. CFR 315.5(d). 379 See, e.g., Federal Trade Commission, Halloween know-how: Cosmetic contacts require an Rx, https://www.consumer.ftc.gov/blog/2019/10/ halloween-know-how-cosmetic-contacts-require-rx; Federal Trade Commission, Prescription Glasses and Contact Lenses, https://www.consumer.ftc.gov/ articles/0116-prescription-glasses-and-contactlenses (‘‘All contact lenses—even ones just meant to change your appearance—require a prescription.’’). 380 NPRM, 81 FR at 88544–5. Other concerns about passive verification, unrelated to the length of time a prescriber has to respond to a verification request, are addressed in Sections III, IV, and V.A and B. 381 Id. 382 Coalition for Contact Lens Consumer Choice (WS Comment #3239); Consumer Action (NPRM Comment #3721); Consumers Union (NPRM 378 16 VerDate Sep<11>2014 20:17 Aug 14, 2020 Jkt 250001 commenters continued to express concerns with the limited time frame,383 particularly due to the potential negative health consequences for patients wearing non-prescribed lenses, should a prescriber fail to deny an invalid verification request in time.384 Many prescribers wrote that eight business hours was just not a sufficient amount of time to respond due to, for example, busy offices, limited staff, high volume of requests, and regular office closures on business days.385 Comment 3969) (stating that eight business hours ‘‘was generally sufficient and has proven workable,’’ but suggesting that the period could be changed to twenty-four hours with weekends and holidays excluded); see also CLR Panel IV Tr., supra note 121, at 16 (statement of Cindy Williams) (stating that eight hours is sufficient time to respond). 383 See, e.g., Becker (WS Comment #571); Contact Lens Association of Ophthalmologists, Inc. (WS Comment #770); Begeny-Mahan (WS Comment #1702) (requesting that the eight-business-hour period be changed to forty-eight hours); Kirkconnell (WS Comment #1754) (requesting two business days to respond and stating that requests should be faxed); American Society of Cataract and Refractive Surgery (WS Comment #3142) (advocating for extending the eight-business-hour time-period for passive verification to five business days); HanenSmith (NPRM Comment #154); Cade (NPRM Comment #2163) (suggesting that sellers should exclude a weekday from the eight-business-hour calculation if they become aware that the prescriber’s office is closed); American Academy of Opthalmology (NPRM Comment #3657) (proposing lengthening the response period to two business days); Coalition for Patient Vision Care Safety (NPRM Comment #3883); Contact Lens Association of Ophthalmologists (NPRM Comment #4259) (asking that the period be extended to two days). 384 See, e.g., Rhee (WS Comment #3468); Meyers (NPRM Comment #173); Gilberg (NPRM Comment #198); Engler (NPRM Comment #453); Kempf (NPRM Comment #915); McPherson (NPRM Comment #3397); American Society of Cataract and Refractive Surgery (NPRM Comment #3820); Tesinsky (NPRM Comment #4012). 385 Boyer (SNPRM Comment #59); Becker (WS Comment #571) (recommending two business days); Contact Lens Association of Ophthalmologists, Inc. (WS Comment #770); Begeny-Mahan (WS Comment 1702) (stating that the eight-hour period is a problem because the office is closed on Wednesdays); Huynh (WS Comment #1940); Dhaliwal (WS Comment #2684); American Society of Cataract and Refractive Surgery (WS Comment #3142); Morales (WS Comment #3404); Yu-Davis (WS Comment #3410), Rhee (WS Comment #3468); Meyers (NPRM Comment #173); Pierce (NPRM Comment #187) (estimating that the office spends approximately twelve minutes responding to a verification request); Kempf (NPRM Comment #915) (stating that the office is closed on Wednesdays and incorrect prescriptions received late on Tuesday will be filled); Goodman (NPRM Comment #1340) (stating that the prescriber is unable to respond to requests within the eight-hour period because the office is closed on Mondays); Speiser (NPRM Comment #2233) (stating that eight hours are not enough time because the doctor spends time at the hospital and is not in the office every day); Weingeist (NPRM Comment #2496) (stating that the practice is small and the requests are burdensome); American Society of Cataract and Refractive Surgery (NPRM Comment #3820); McPherson (NPRM Comment #3397) (stating that the office is very busy with patients and verification requests can be forgotten). PO 00000 Frm 00029 Fmt 4701 Sfmt 4700 50695 The Commission considered these comments and, for the reasons stated in the NPRM, declines to change the eightbusiness-hour period, including by lengthening the period or changing how the period is calculated. Congress mandated the verification system and that a prescriber respond within ‘‘8 business hours, or a similar time as defined by the Federal Trade Commission.’’ 386 In determining this time period, Congress balanced the harm to consumers if they were unduly delayed in receiving their contact lenses against the harm from receiving contact lenses based on an invalid prescription.387 The Commission does not find any compelling changes to the marketplace since the Rule’s promulgation in 2004 that support extending the eight business hour period.388 386 NPRM, 81 FR at 88544. Some prescribers or sellers may be confused about when the eightbusiness-hour period starts following a verification request and the applicable time zone. See, e.g., Goodman (WS Comment #599); Palmer (WS Comment #2215); Wang (WS Comment #3448); Gilberg (NPRM Comment #198); Huff (NPRM Comment #1964); Osterholzer (NPRM Comment #2085) (stating that the office is not open during the same hours as the seller and in a different time zone). Under the Rule, when a request is received after 5 p.m., the eight-business- hour period would not start until 9 a.m. the next weekday that is not a federal holiday, or if applicable, on Saturday at the beginning of the prescriber’s actual business hours. A business hour is determined based on the time zone of the prescriber. 16 CFR 315.2, 315.5. 387 NPRM, 81 FR at 88544. 388 The Commission recognizes a need for clarification with respect to whether a seller can ship lenses to a consumer after receiving notification from a prescriber that the submitted prescription is inaccurate, invalid, or expired but when such notification occurs after the eightbusiness-hour period has passed. In its initial rulemaking, the Commission declined to expressly prohibit sellers from shipping lenses in such an instance, but noted that nothing in the Rule prohibits a prescriber from submitting late notifications to the seller or the seller from acting upon them, and that it would likely be in the best interest of their mutual consumer for them to do so. Contact Lens Rule, 69 FR 40050. However, the Commission is aware that the marketplace for contact lens sales now includes subscription models, in which sellers provide a quantity of lenses to consumers, not in a single-delivery supply, but rather in periodic installments (usually every month, although sometimes quarterly or semiannually). In such a circumstance, the seller would have plenty of time to halt a subsequent installment shipment after being informed that the consumer’s prescription was invalid, inaccurate, or expired. Therefore, the Commission clarifies that while the Rule does not prohibit an initial shipment to a consumer in instances where the seller received such notification after the eight-business-hour period has passed, any subsequent shipments based on the initial verification request would violate the Rule. A seller who has been notified that the patient does not have a valid prescription cannot ignore such notification and continue to sell and ship lenses every month simply because the notification came in after the eight-business-hour deadline. E:\FR\FM\17AUR2.SGM 17AUR2 50696 Federal Register / Vol. 85, No. 159 / Monday, August 17, 2020 / Rules and Regulations VI. Seller Alteration of Contact Lens Prescriptions and Private Label Concerns The current Rule states that a ‘‘seller may not alter a contact lens prescription.’’ The only exception applies to private label contact lenses and allows the seller, when a patient has a prescription for private label contact lenses, to substitute identical contact lenses that the same company manufactures and sells under a different name.389 In the SNPRM, the Commission expressed its concern about the emergence of sellers’ business models that rely exclusively on passive verification as a means to substitute their own brand of contact lenses for the prescribed lens.390 As noted in the SNPRM, many prescribers detailed harm that resulted from wearing unprescribed lenses, such as headaches, corneal neovascularization, corneal ulcers, and other irreversible and visionthreatening diagnoses.391 As a result, the Commission proposed two modifications to the Rule. The first modification proposed in the SNPRM, adding a paragraph (g) to § 315.5, would require sellers to provide a clear and prominent method for the patient to present the seller with a copy of the patient’s prescription. Such method might include, without limitation, electronic mail, text message, file upload, or facsimile. The Commission stated that this proposal would address prescriber and manufacturer concerns by increasing the number of patients who present online sellers with their prescriptions rather than relying on verification.392 The second modification proposed in the SNPRM targeted concerns about prescription verification more directly. The proposed modification of § 315.5(f) would define alteration to include a seller’s providing, as part of a verification request, a prescriber with a manufacturer or brand other than that specified on a patient’s prescription. The proposal included an exception, however, for sellers when they provide a manufacturer or brand that a patient provided to the seller, either on the order form or orally in response to a request for the manufacturer or brand listed on the prescription. In other words, to avail themselves of the exception, sellers must ask consumers to provide the manufacturer or brand listed on their prescription. The SNPRM further provided that a seller would not 389 16 CFR 315.5(e). 84 FR at 24687–88. 391 Id. at 24686. 392 Id. at 24688. 390 SNPRM, VerDate Sep<11>2014 20:17 Aug 14, 2020 Jkt 250001 be able to avail itself of the exception by relying on a prepopulated or preselected box, or on consumers’ online searches for a particular manufacturer or brand, as an indication that they were prescribed that manufacturer or brand.393 A seller not covered under the exception discussed above who made a verification request containing a manufacturer or brand other than, and not identical to, the one written on the consumer’s prescription by their prescriber, would violate the Rule, even if a prescriber subsequently invalidated the request and the lenses were never sold.394 A. The Final Rule Includes a Requirement for Sellers To Accept Prescription Presentation Commenters who discussed the Commission’s proposal to require sellers to provide a clear and prominent method to present prescriptions were unanimous in their support, although some suggested revisions that they believed would make it more effective.395 A number of commenters asserted that this amendment would help decrease the number of verification requests 396 and eliminate errors stemming from incorrect verification requests.397 In addition, the NAOO pointed out that such presentation benefits the consumer and the seller by reducing the time needed to fill the order and providing additional assurance of the prescription’s validity.398 1–800 CONTACTS also supported—and says that it already complies with—the prescription presentation proposal.399 Simple Contacts commented that the proposed requirement is fair, and opined that ‘‘any seller who does not support prescription presentation has not made a good faith attempt to accurately verify 393 Id. at 24689. 394 Id. 395 Simple Contacts (SNPRM Comment #87); American Optometric Association (SNPRM Comment #96); Health Care Alliance for Patient Safety (SNPRM Comment #128); National Association of Optometrists and Opticians (SNPRM Comment #129); 1–800 CONTACTS (SNPRM Comment #135); Johnson & Johnson Vision Care, Inc. (SNPRM Comment #151). 396 Health Care Alliance for Patient Safety (SNPRM Comment #128); National Association of Optometrists and Opticians (SNPRM Comment #129); Johnson & Johnson Vision Care, Inc. (SNPRM Comment #151). 397 Health Care Alliance for Patient Safety (SNPRM Comment #128); National Association of Optometrists and Opticians (SNPRM Comment #129); 1–800 CONTACTS (SNPRM Comment #135); Johnson & Johnson Vision Care, Inc. (SNPRM Comment #151). 398 National Association of Optometrists and Opticians (SNPRM Comment #129). 399 1–800 CONTACTS (SNPRM Comment #135). PO 00000 Frm 00030 Fmt 4701 Sfmt 4700 all patient prescriptions.’’ 400 Simple Contacts, however, expressed skepticism that the amendment would significantly reduce the number of alterations by sellers abusing the passive verification system.401 Because the Commission did not receive any comments opposing this proposal, the Commission is incorporating the requirement in its Final Rule. The Commission believes the proposal will help reduce the number of verifications, reduce errors associated with incorrect verification attempts, and make it more difficult for ill-intentioned sellers to abuse the passive verification framework and take advantage of consumers who might not realize that the seller intends to verify a different lens than the one written on their prescription. In the Final Rule, the Commission has changed the ‘‘clear and prominent’’ requirement to pertain to a disclosure of the method of prescription presentation (e.g., a disclosure that the method is available to provide the prescription). In so doing, the Commission makes clear that sellers cannot provide a method of prescription presentation without also providing a clear and prominent disclosure thereof.402 The Commission has retained the requirement that the method (e.g., email address, phone number to receive text messages, or upload link) be prominent.403 The Commission has also determined that it is unnecessary to include prescribers in this section of the Rule since it pertains to the ordering process between a seller and a consumer.404 Commenters suggested three additional requirements for the prescription presentation proposal. First, the NAOO suggested the 400 Simple Contacts (SNPRM Comment #87). See also National Association of Optometrists and Opticians (SNPRM Comment #129) (‘‘Contact lens sellers that do not provide a method to upload the prescription may be trying to avoid getting the patient’s specific brand information, so that they can switch the patient into a different proprietary brand.’’). 401 Simple Contacts (SNPRM Comment #87). The Health Care Alliance for Patient Safety stated that ‘‘it is unclear whether the proposed amendment would have any effect on the incidence of alteration[s]’’ since the Commission is not also prohibiting calls containing automated verification messages. SNPRM Comment #128. 402 For telephone orders, sellers would comply by making a prominent method available and giving clear and prominent notice of the method. 403 The Commission finds its proposed SNPRM requirement that the method be clear unnecessary given the new language requiring the disclosure of the method to be clear and prominent. 404 The Rule anticipates prescription presentation by prescribers to sellers. Section 315.5(a)(1) indicates that one way sellers can sell contact lenses is if they receive a prescription from a prescriber directly or by facsimile. 16 CFR 315.5(a)(1). E:\FR\FM\17AUR2.SGM 17AUR2 Federal Register / Vol. 85, No. 159 / Monday, August 17, 2020 / Rules and Regulations Commission require that the method to present prescriptions be in close proximity to the option to provide the parameters of the contact lens for verification, so as to increase the likelihood that consumers would understand they have a choice between providing a prescription or having one verified with their prescriber.405 As drafted, the language did not specify at what point in the process a seller must make the method for prescription presentation available. The Commission believes that the NAOO’s suggestion of close proximity would be helpful, but notes that if the method, and a disclosure thereof, are provided in close proximity but after the collection of all information required for verification is provided, the prescription presentation benefit may be diminished. In other words, if a consumer enters all the information required for verification (contact lens brand, powers, prescriber name and phone number) before learning about prescription presentation, and having an opportunity to present the prescription, the consumer may choose not to also provide the prescription. As a result, the Commission is amending the language of § 315.5(g) in the Final Rule to require that the method and the disclosure of the method for the patient to present the seller with a copy of the patient’s prescription must be prior to requesting a prescriber’s contact information, which is necessary to verify a contact lens prescription.406 Two commenters opined on whether consumers should be able to choose the method for providing their prescriptions. Consumer Reports stated its belief that, when offering prescription presentation, sellers should be required to provide consumers all four methods listed in the proposed Rule—electronic mail, text message, file upload, and facsimile—in lieu of giving sellers the option to choose from those methods.407 It indicated that requiring all four would not burden the seller, and there may be reasons that patients prefer one option over the others.408 On the other hand, the NAOO supported the Commission’s proposal to let the seller decide the method.409 The Commission has decided to require sellers to offer 405 National Association of Optometrists and Opticians (SNPRM Comment #129). 406 In the case of orders placed by telephone, the Rule requires sellers to provide clear and prominent disclosure of the method for prescription presentation (e.g., a seller’s email address) prior to requesting a prescriber’s contact information. 407 Consumer Reports (SNPRM Comment #133). 408 Id. 409 National Association of Optometrists and Opticians (SNPRM Comment #129). VerDate Sep<11>2014 20:17 Aug 14, 2020 Jkt 250001 prescription presentation by the same medium through which the order is placed, or by electronic mail, text message, or file upload.410 When orders are placed via telephone, sellers are required to offer prescription presentation via electronic mail, text message, or file upload. Because faxes are not commonly used by consumers, sellers can offer fax presentation as the sole option only when the orders are placed by fax. This framework gives consumers and prescribers an opportunity to present prescriptions, while limiting the burden on sellers, some of whom are small.411 The Commission believes that these changes from the SNPRM proposal are not significant, are consistent with the stated purpose of the proposal as outlined in the SNPRM,412 and will help ensure the maximum benefit from the Rule change. Consumer Reports also recommended that sellers be required not just to accept prescription presentation, but also to specifically request and encourage patients to provide prescriptions.413 The Commission declines to adopt this suggestion. The Commission’s Final Rule requires sellers to accept prescriptions. The Final Rule also requires that sellers clearly and prominently disclose how consumers can provide them with prescriptions. Sellers that more overtly request or encourage the submission of prescriptions (e.g., through price cuts and faster delivery times) will likely further increase the number of prescriptions presented, allowing both sellers and consumers to reap the benefits. However, the Commission has determined that beyond providing a method for consumers to present their prescriptions and notice of such method prior to requesting their prescriber’s contact information, sellers should have discretion whether to promote or incentivize that practice. 410 A seller who chooses to offer all methods will likely benefit by having more consumers provide prescriptions than if it offered only one or even two methods. Benefits to sellers from having prescriptions on file include avoiding the costs involved in verification, and having the ability to provide contact lenses more quickly than relying on verification. 411 For all orders, sellers can meet the requirement by accepting prescriptions via email. There should not be a significant burden on business to obtain and maintain an email address and process and store prescriptions received through email. 412 SNPRM, 84 FR at 24688–89. 413 Consumer Reports (SNPRM Comment #133). PO 00000 Frm 00031 Fmt 4701 Sfmt 4700 50697 B. Alteration Includes a Seller Providing a Prescriber With a Verification Request for a Non-Prescribed Manufacturer or Brand, but Includes an Exception for Verifying a Manufacturer or Brand That a Consumer Indicates Is on Her Prescription In the SNPRM, the Commission proposed a modification of § 315.5(f) to define alteration to include a seller’s providing, as part of a verification request, a prescriber with a manufacturer or brand other than that specified on a patient’s prescription. The proposal included an exception, however, for sellers when they provide in a verification request a manufacturer or brand that a patient provided to the seller, either on the order form or orally in response to a request for the manufacturer or brand listed on the prescription.414 As discussed below, in the Final Rule, the Commission has determined to adopt this definition of alteration along with a modified version of the accompanying exception. 1. The Final Rule Modifications Regarding Alteration Are Beneficial and Address Abuses of the Verification System 1–800 CONTACTS expressed its belief that the proposed alteration modification was unnecessary and requested that the Commission carefully evaluate any new regulations that could interfere with the convenience and competitive pricing of legitimate sellers.415 Although the seller recognized the presence of single-brand sellers in the market, and the problems some cause, 1–800 CONTACTS stated that the addition of quality standards for verification calls, along with targeted enforcement against sellers with a business model based solely on noncompliant verification methods, would reduce the ability of these sellers to profit from abusing the passive verification system.416 Specifically, it felt that ‘‘enforcement against one such business [ ] would likely be sufficient to chill or completely eliminate replication of this business model.’’ 417 The Commission agrees that the requirement to provide a method for prescription presentation, and a disclosure thereof, should reduce the number of verification requests, and that the addition of quality standards for verification calls should reduce the incidence of non-compliant verification calls and increase the ability of prescribers to deny invalid requests or 414 SNPRM, 415 1–800 84 FR at 24698. CONTACTS (SNPRM Comment #135). 416 Id. 417 Id. E:\FR\FM\17AUR2.SGM 17AUR2 50698 Federal Register / Vol. 85, No. 159 / Monday, August 17, 2020 / Rules and Regulations correct inaccurate ones. However, based on comments from prescribers as well as its own investigations and experience, the Commission believes those amendments on their own are inadequate to curb the practice of substitution to non-prescribed brands through abuse of the verification system. The Commission has previously stated that, under the existing Rule, a verification request is not valid and does not commence the eight-businesshour verification period if a seller knows or should know that the verification request includes a different brand and manufacturer than that prescribed.418 Any sales after such requests violate the Rule, even if a prescriber has not responded. In these instances, the seller is not selling in accordance with a prescription. Despite clearly articulating this position, the FTC continues to receive reports about the proliferation of passive verification abuses. Furthermore, sellers may argue that they are technically compliant with the Rule because they submitted verification requests and prescribers had an opportunity to respond to the requests. They may also argue that they did not have knowledge that a consumer did not have a prescription for that manufacturer or brand of lens. Additionally, this is not an issue of one bad actor. As noted in the SNPRM, the Commission has seen the emergence of businesses that rely exclusively, or almost exclusively, on passive verification as a means to substitute their own brand of contact lenses.419 Simple Contacts’ comment notes that, within the last two years, several new companies have entered the U.S. market and that their abuse of the verification system appears willful.420 The AOA similarly noted an increase of direct-toconsumer brands and named three new market entrants that reportedly replace their own brand of lenses for the prescribed brand.421 The Commission therefore sees benefits to defining alteration to include a seller’s providing a prescriber, as part of a verification request, with a manufacturer or brand other than that specified on a patient’s prescription. 2. Comments Related to the Exception to Alteration When a Seller Provides the Manufacturer or Brand of Lenses That a Consumer Provides in Response to a Seller’s Request for That Information The SNPRM proposed that sellers receive an exception from alteration when they provide, in a verification request, a manufacturer or brand that a patient provided to them, either on the order form or orally in response to a request for the manufacturer or brand listed on the prescription.422 If the seller seeks to verify a manufacturer or brand other than that indicated by the consumer, even if a prescriber ultimately denies the request, the seller has committed a violation. The implementation of the alteration definition, including the exception, should serve as an effective deterrent against sellers that try to game the verification system to sell nonprescribed contact lenses. In response to the SNPRM, commenters expressed concerns that some sellers might take advantage of the exception by inducing, suggesting, advertising, or otherwise causing consumers to provide a name other than that on their prescription so as to allow the seller to seek verification of a brand that had not been prescribed for the consumer.423 The NAOO was specifically concerned that ‘‘less scrupulous sellers’’ would attempt to take advantage of this exception, and noted that currently some sellers only request the power of the lenses from the customer and then ask prescribers to verify a prescription with a private label brand.424 Commenters proffered different recommendations as to how to address this issue. CooperVision requested that the Commission state in a guidance document that sellers cannot induce, suggest, advertise, or otherwise cause patients to provide the wrong name, and to provide examples of improper statements.425 Johnson & Johnson Vision Care suggested that, should the Commission retain the exception, it should add the following clarifying language to the preamble section of the Rule: ‘‘This exception is intended to provide explicit direction for sellers as to when they are responsible for instances of prescription alteration. Under no circumstances may a seller, wishing to avail themselves of 422 SNPRM, 84 FR at 24686. Association of Optometrists and Opticians (SNPRM Comment #129); CooperVision, Inc. (SNPRM Comment #130); Johnson & Johnson Vision Care, Inc. (SNPRM Comment #151). 424 National Association of Optometrists and Opticians (SNPRM Comment #129). 425 CooperVision, Inc. (SNPRM Comment #130). 423 National 418 SNPRM, 84 FR at 24687–88. 84 FR at 24687. 420 Simple Contacts (SNRPM Comment #87). 421 American Optometric Association (SNPRM Comment #96). 419 SNPRM, VerDate Sep<11>2014 20:17 Aug 14, 2020 Jkt 250001 PO 00000 Frm 00032 Fmt 4701 Sfmt 4700 this exception, direct, encourage, motivate, or suggest, either implicitly or explicitly, that a patient enter any manufacturer or brand other than that listed on the patient’s prescription.’’ 426 The NAOO recommended that the Rule itself be further amended to provide more specific direction as to what the seller must, may, and cannot do when asking patients for the information the FCLCA requires in a verification request. Specifically, it recommended adding a requirement that to avail itself of the exception, a seller must have had no reason to believe that the name provided by the consumer was not the manufacturer or brand listed on that consumer’s prescription.427 The Commission agrees that sellers must not induce, suggest, advertise, or otherwise lead consumers to provide a manufacturer or brand different from that listed on their prescriptions. The Commission believes, however, that the recommended change is unnecessary because, should a seller attempt to induce or trick the consumer into providing the seller with a manufacturer or brand different from that listed on the consumer’s prescription, it would not be able to avail itself of the exception. Any such conduct by the seller would call into question whether the consumer had provided the seller with the manufacturer or brand listed on her prescription in response to a clear request for such information, as required by the Rule. Commenters expressed concern that the exception for patient prescription entry would allow consumers to override their prescriptions by providing a manufacturer or brand of contact lenses other than that prescribed to them by their prescriber.428 Similarly, one commenter stated that sellers should ensure that consumers understand that they need to request the lens specified on their prescription and, if consumers want a different lens, 426 Johnson & Johnson Vision Care recognized that the exception could serve as guidance for sellers to determine whether they are responsible for an illegal prescription alteration. However, it believes the exception should not be added to the Rule because a patient may not be able to correctly enter their information given the nuances of a contact lens prescription and the meaning of the different elements therein. Ultimately, Johnson & Johnson Vision Care is concerned that the exception may contribute to passive verification of an inaccurate prescription, and thus, illegal substitution. SNPRM Comment #151. The Commission does not believe that this concern is relevant to the exception, which relates to a consumer only providing her manufacturer or brand. 427 National Association of Optometrists and Opticians (SNPRM Comment #129). 428 American Optometric Association (SNPRM Comment #96); Health Care Alliance for Patient Safety (SNPRM Comment #128). E:\FR\FM\17AUR2.SGM 17AUR2 Federal Register / Vol. 85, No. 159 / Monday, August 17, 2020 / Rules and Regulations sellers shall state prominently that consumers must discuss the request with, and make the change through, their prescribers.429 The concern that this amendment gives consumers permission to override their prescriptions, including choosing a new brand, is unfounded. The exception in no way gives consumers the ability to override prescribers’ prescriptions, and it does not change the prescriber’s ability to inform a seller that the prescription submitted for verification is inaccurate, expired, or otherwise invalid.430 In fact, by requiring sellers to ask consumers their manufacturer or brand to meet the exception, the proposal is encouraging just the opposite—inviting consumers to choose the brand prescribed for them. And, once the seller receives a communication from the prescriber that the prescription is invalid, it cannot sell the lenses without violating the Rule. The Commission therefore does not see a need to require sellers to inform consumers that if they want a different lens, they must go to their prescribers. Asking consumers for the manufacturer or brand listed on their prescriptions, and clarifying that sellers may not induce, suggest, or otherwise cause consumers to select or provide a manufacturer or brand other than that prescribed, should be adequate to curtail much of the illegal alterations occurring through abuse of the verification system. Moreover, the Commission has issued consumer notices that indicate that if consumers wish to switch their brand of lens, they need to contact their prescribers.431 The Commission will continue its educational efforts in this area. 3. Comments Regarding and Commission Guidance on Acceptable Methods for Obtaining the Brand or Manufacturer Listed on Consumers’ Prescriptions 1–800 CONTACTS expressed concern that the Commission’s amendment might interfere with its ability to improve the user experience. It 429 CooperVision, Inc. (SNPRM Comment #130). Rule 16 CFR 315.5(e). Despite this prohibition, substitution to another brand of lenses was always a risk with passive verification, but it was a risk Congress considered before instituting the verification framework set forth in the Act. See, e.g., FCLCA Subcomm. Hearing, supra note 17 (statements of Howard Beales, Federal Trade Commission); id. (statements of J. Pat Cummings, American Optometric Association) (‘‘And the problem with passive verification is that people will get contact lenses without a prescription.’’). 431 See, e.g., Federal Trade Commission, Prescription Glasses and Contact Lenses, https:// www.consumer.ftc.gov/articles/0116-prescriptionglasses-and-contact-lenses (last visited Nov. 19, 2019). 430 Final VerDate Sep<11>2014 20:17 Aug 14, 2020 Jkt 250001 indicated that it sells hundreds of brands of lenses and offers consumers a variety of methods to identify their brand, including drop-down menus, a search box, and filters that display lenses by brand, modality, and other parameters and that some consumers do not enter their brand information on an order form.432 Simple Contacts asked for greater specificity on the acceptable mechanisms for soliciting the contact lens brand or manufacturer, as a way to prevent bad actors from finding mechanisms to circumvent the intent of the Rule. Simple Contacts recommended limiting such mechanisms to five: Providing verbal confirmation of the brand or manufacturer; providing a copy of a prior prescription indicating the brand or manufacturer; typing a selection into a free entry text or search field; selecting a brand or manufacturer from a list or database containing the majority of commercially available brands (e.g., a drop-down menu), or providing a photo of a contact lens box.433 Johnson & Johnson Vision Care opined that should the Commission proceed with the exception, a seller should not be able to avail itself of the exception by relying on a prepopulated or preselected box, or on consumers’ online searches for a particular brand or manufacturer, as a representation by consumers that they do, in fact, have a prescription for that brand or manufacturer. In contrast to the view expressed by 1–800 CONTACTS and Simple Contacts, Johnson & Johnson Vision Care requested the Commission prohibit drop-down menus and similar tools as methods by which a seller could avail itself of the exception.434 The Commission agrees that greater specificity surrounding acceptable methods would benefit sellers trying to comply with the Rule, but recognizes the myriad of ways consumers can interact with sellers to purchase lenses. Specifically, the Commission agrees that the requirement to provide the manufacturer or brand if not orally, then on an order form, imposes unnecessary limits for a consumer to select her manufacturer or brand. As a result, it is removing the term ‘‘order form’’ from the Final Rule. However, while sensitive to sellers’ needs to create the best and most convenient consumer experience, 432 1–800 CONTACTS (SNPRM Comment #135). 433 Simple Contacts (SNPRM Comment #87). The NAOO also stated that a seller should be able to rely on a customer-provided photograph of packaging of contact lenses for a current prescription. SNPRM Comment #129. 434 Johnson & Johnson Vision Care, Inc. (SNPRM Comment #151). PO 00000 Frm 00033 Fmt 4701 Sfmt 4700 50699 the Commission believes requiring that they ask for the name of the manufacturer or brand listed on consumers’ prescriptions can still be done while providing a positive purchasing experience for their customers. At a minimum, in order for sellers to consider the consumer’s indication of manufacturer or brand as adequate to qualify for the exception, the manufacturer or brand must be: (1) Provided in response to a seller’s request for the manufacturer or brand listed on the consumer’s prescription, and (2) an affirmative statement or selection by the consumer, not a preselected or prefilled entry (collectively ‘‘the minimum criteria’’). As to the first minimum criterion, a seller cannot assume that a consumer who searches on the internet for a specific manufacturer or brand of lens has a prescription for that manufacturer or brand of lens. Similarly, a consumer’s selection next to a request for the manufacturer or brand the consumer wears or wishes to purchase would be insufficient because a consumer may be wearing or attempting to order a nonprescribed lens. In contrast, a seller can reasonably rely on a consumer’s entry of a manufacturer or brand in response to a request for the ‘‘manufacturer or brand listed on your prescription.’’ The second minimum criterion for sellers to qualify for the exception is that they must elicit from the consumer an affirmative statement or selection of the manufacturer or brand. A seller that relies on a preselected, prechecked box stating ‘‘I agree I have a prescription for this brand,’’ or something similar, would not qualify for the exception to alteration. For telephone orders, the consumer must state the name of the manufacturer or brand in response to a seller’s request for the manufacturer or brand listed on her prescription.435 A seller can rely on a consumer-provided photograph of a contact lens box or a copy of a prior prescription so long as the seller meets the two minimum criteria listed above and obtains additional information from the consumer or prescriber that the consumer has a current prescription for that brand.436 The Commission is not limiting the permissible methods for obtaining 435 A seller receiving an affirmative response to its request ‘‘Do you have a prescription for this brand?’’ would be unable to meet the exception. 436 The information from the prescriber or consumer would provide the seller with a basis for the verification other than the expired prescription. See Section X.B., supra and NPRM, 81 FR at 88546– 67 (a seller may not use an expired prescription as the basis for a verification request). E:\FR\FM\17AUR2.SGM 17AUR2 50700 Federal Register / Vol. 85, No. 159 / Monday, August 17, 2020 / Rules and Regulations manufacturer or brand to meet the exception to only those discussed above. The Commission instead is leaving sellers the option of deriving other ways to elicit the prescribed manufacturer or brand, within the guidelines discussed in this section. The Commission also declines to add a preamble further explaining the ways for sellers to meet the exception, but instead relies on this notice as guidance. 1–800 CONTACTS opined that the Commission should not refer to ‘‘brand’’ in the amendment to the Rule as that language does not appear elsewhere in the Rule. It points out that the Rule defines a prescription as including a ‘‘material or manufacturer or both’’ and that the Commission’s inclusion of the reference to brand imposes an additional limit on consumer choice that the Act does not require. 1–800 CONTACTS requested instead that the exception to the Rule be applicable to ‘‘providing the prescriber with the name of a manufacturer or material other than that specified by the patient’s prescriber . . . .’’ The reference to brand in the definition of alteration and in the exception would indeed be the only references to brand in the Rule. However, in practice, it appears many, if not most, prescriptions list the manufacturer’s brand, not the manufacturer or material, and the brand is viewed as shorthand for the entire device.437 Furthermore, very few consumers know the manufacturer or material of contact lens that they wear, and typically refer to their lenses by brand name. Amending the exception in the way 1–800 CONTACTS recommended would be unworkable since many consumers would be unable to provide the manufacturer or material in response to a seller’s request, and might even have to ask their prescribers. Should prescribers’ practices change from listing a brand on a prescription to listing a manufacturer or material, the Commission will reevaluate its decision. 4. The Commission Is Not Imposing a Recordkeeping Requirement for Sellers Related to the Exception Lastly, CooperVision strongly recommended that the Commission reconsider its decision not to require sellers to keep records related to the exception and noted that the Rule relies heavily on requiring written evidence. CooperVision claimed that the lack of a 437 SNPRM, 84 FR at 24686 n.299. See also National Association of Optometrists and Opticians (SNPRM Comment #129) (noting as an example that many, if not most, prescriptions for My Day lenses manufactured by CooperVision get written as ‘‘My Day,’’ not as ‘‘CooperVision’’ or ‘‘CooperVision My Day’’). VerDate Sep<11>2014 20:17 Aug 14, 2020 Jkt 250001 recordkeeping requirement would leave a gap that could be exploited, and would make it difficult for the Commission to pursue enforcement against sellers who violate the Rule.438 The Commission disagrees with this assessment. Since the exception to alteration would be a defense for a seller, the seller would have the burden of proof to show it met the exception. Should the Commission believe that the seller has altered a contact lens prescription and submitted a verification request for a manufacturer or brand other than that indicated by a consumer, the seller would need evidence that it meets the exception. Sellers who determine not to maintain records do so at their own peril. C. Private Label Issues Although most contact lenses in the United States are sold under national brand names (such as Acuvue Oasys, or Dailies Aquacomfort Plus), some manufacturers distribute their lenses to prescribers and retail sellers under private labels (such as Costco’s Kirkland Signature contact lens brand or LensCrafters 1-Day Premium contact lenses). Private label contact lenses can be unique to one seller, or the private label brand may be available at multiple unaffiliated sellers.439 Despite the label, however, the lenses inside the packaging are exactly the same as lenses sold under a national brand.440 1. The Commission Adopts a Technical Amendment and Clarifies That the Only Permissible Substitution Involves Private Label Lenses In § 315.2, the Rule defines private label lenses as ‘‘contact lenses that are sold under the label of a seller where the contact lenses are identical to lenses made by the same manufacturer but sold under the labels of other sellers.’’ 441 The Rule also provides that a prescription for private label contact lenses must include, in addition to other required information, the name of the manufacturer, trade name of the private label brand, and if applicable, the trade name of equivalent brand name.442 The Rule’s definition for a private label lens prescription tracks the language of the Act.443 With respect to how sellers treat and substitute private label lenses, however, 438 CooperVision, 439 2005 Inc. (SNPRM Comment #130). Contact Lens Report, supra note 14, at 14–15. 440 For example, Costco’s Kirkland Signature Premium Daily Disposable lenses are the same as CooperVision MyDay disposable lenses. 441 16 CFR 315.2. 442 Id. 443 See 15 U.S.C. 7610(3)(H). PO 00000 Frm 00034 Fmt 4701 Sfmt 4700 the Commission recognized in the NPRM that the construction of § 315.5(e) of the Rule does not presently conform to the language or intent of the Act.444 The clear language of the Act allows sellers to substitute national brand name lenses for private label lenses, and vice versa, so long as it is ‘‘the same contact lens manufactured by the same company and sold under multiple labels to individual providers.’’ 445 The Rule, meanwhile, states that a seller may ‘‘substitute for private label contact lenses specified on a prescription identical contact lenses that the same company manufactures and sells under different labels.’’ 446 The different language of the Act thus allows sellers to substitute brand names for identical private labels, and private labels for identical brand names, while the Rule, as currently drafted, could be read to proscribe the latter. To conform the Rule to the Act, the Commission proposed in the NPRM to strike the words ‘‘private label’’ from § 315.5(e), so it would state that a seller may ‘‘substitute for contact lenses specified on a prescription identical contact lenses that the same company manufactures and sells under different labels.’’ 447 The Rule’s definitions of a ‘‘contact lens prescription’’ and of a ‘‘private label contact lens’’ would remain unchanged. The Commission made this proposal after becoming aware that, in addition to prescribers, some other sellers (such as Costco) now market and sell private label contact lenses that are identical to, and are made by the same manufacturer as, brand name contact lenses. As a result, when a patient presents a contact lens prescription for brand name contact lenses to certain sellers, those sellers may wish to sell, as a substitute, their own private label lenses to the patient. While the Commission’s proposal was intended to clarify the Rule and align it with the Act’s intent, some commenters opposed the change because they believed it could be interpreted as allowing substitution beyond that of private label lenses.448 According to Johnson & Johnson Vision Care, the 444 NPRM, 81 FR at 88552. U.S.C. 7603(f). Although the Commission imagines it would be quite rare, it believes a seller should be permitted under the Rule to substitute one private label lens for another private label lens so long as the lenses are identical. 446 16 CFR 315.5(e). 447 NPRM, 81 FR at 88552. 448 Johnson & Johnson Vision Care, Inc. (NPRM Comment #4327); see also Tesinsky (NPRM Comment #4012) (fearing change may be interpreted as the ‘‘ability to substitute a different contact by the same manufacturer (for example substituting Acuvue Oasys for Acuvue Vita), rather than just a private label substitute’’). 445 15 E:\FR\FM\17AUR2.SGM 17AUR2 Federal Register / Vol. 85, No. 159 / Monday, August 17, 2020 / Rules and Regulations ‘‘private label’’ modifier is necessary to provide guidance that the only instance in which a seller can lawfully substitute lenses for those written on a prescription is for identical private label lenses, and that removing the words ‘‘private label’’ from the command section of the Rule (leaving it only in the definitions section), will render the term meaningless.449 The removal of this term is especially problematic, according to the manufacturer, because illegal substitution is a problem in the marketplace, and it could ultimately cause undue, avoidable harm to patient eye health and vision safety.450 Should the Commission choose to proceed with its removal of the term ‘‘private label’’ from § 315.5(e), Johnson & Johnson Vision Care requested that the Commission explicitly clarify that such removal does not allow for substitution beyond the scope of private label lenses or identical contact lenses that the same company manufactures and sells under different labels. It further suggested that the most appropriate and effective place to clarify how the Commission interprets this Rule provision would be in the preamble of the Rule, rather than the regulatory language itself.451 Costco, in contrast, supported the Commission’s proposed change, because it would make clear that sellers can substitute their own private label contact lenses for prescribed lenses that are identical to lenses made by the same manufacturer and sold under the manufacturer’s brand.452 Although Costco believes that the existing Rule allows it, when presented with a valid prescription for the manufacturer’s brand, to substitute Kirkland Signature lenses, it believed that modifications to the language of § 315.5(e) would clarify and eliminate any doubt about the lawfulness of this practice. Costco also opined that without such a change, the legality of such substitution might be in question, and, as a result, some sellers, particularly those without an established relationship with prescribers, would likely be unwilling 449 Johnson & Johnson Vision Care, Inc. (NPRM Comment #4327); see also American Optometric Association (NPRM Comment #3830) (opposing Commission’s proposal and finding the term ‘‘private label’’ provides necessary clarity to ensure inappropriate substitutions do not occur). 450 Johnson & Johnson Vision Care, Inc. (NPRM Comment #4327). 451 Johnson & Johnson Vision Care, Inc. also supported its position that the clarification should be made in the preamble by reference to the fact that there were not specific reports of sellers encountering issues with the original Rule language. NPRM Comment #4327. 452 Costco Wholesale Corporation (NPRM Comment #4281). VerDate Sep<11>2014 20:17 Aug 14, 2020 Jkt 250001 to invest in a private label lens line.453 Consumers Union also supported the change, indicating that it increases the choices available to consumers, including potentially more affordable options, without in any way undermining patient safety.454 The Commission did not intend for the removal of the words ‘‘private label’’ in the Rule to make substitution more widely permissible beyond that of a seller being able to provide a private label lens when the identical lens (made by the same manufacturer but sold under a different label) is written on the prescription. However, in order to allay concerns, the Commission has retained the term ‘‘private label,’’ but reordered the provision to clarify that permissible substitution only involves private label contact lenses. Thus, the Final Rule allows private label and brand name lenses, when they are identical lenses made by the same manufacturer listed on the prescription, to be substituted for each other.455 2. The Commission Is Not Imposing Additional Requirements on Prescriptions for Private Label Lenses As mentioned above, the Act and the Rule require prescriptions for private label contact lenses to include ‘‘the name of the manufacturer, trade name of the private label brand, and if applicable, trade name of equivalent brand name.’’ 456 LD Vision Group (LensDiscounters.com), in response to the NPRM, provided the Commission with instances of alleged rule violations involving private label prescriptions improperly written or written without equivalents.457 It also requested that the Commission reconsider LD Vision Group’s previous recommendations to: (1) Require prescribers to annotate private label lens prescriptions with the brand-name equivalent and if the namebrand equivalent is unavailable, the private-label prescription must be 453 Id. Costco also commented that bringing a private label lens to market can significantly benefit consumers in terms of introducing lower prices. NPRM Comment #4281. 454 Consumers Union (NPRM Comment #3969). 455 Section 315.5(f) of the Final Rule reads: ‘‘Notwithstanding the preceding sentences, for private label contact lenses, a seller may substitute for contact lenses specified on a prescription identical contact lenses that the same company manufactures and sells under different labels.’’ The Commission revised the provision to refer to the ‘‘preceding sentences’’ to make it clear that the phrase beginning with ‘‘[n]otwithstanding’’ does not apply to anything other than § 315.5(f). 456 15 U.S.C. 7610; 16 CFR 315.2 (in definition of contact lens prescription). 457 This commenter also disagreed with what it stated was the ‘‘Commission’s diminishment of private label concerns.’’ LD Vision Group, Inc. (NPRM Comment #3958). PO 00000 Frm 00035 Fmt 4701 Sfmt 4700 50701 medically necessary for that particular patient; (2) require manufacturers of contact lenses to make brand information available to all sellers, consumers, and the FTC; or (3) require manufacturers and sellers to make brand equivalency information available and easily accessible for private labels on their brand label packaging and online. Although the Commission appreciates the additional information provided by LD Vision Group, the information has not altered the fact, as stated in the SNPRM, that the Act does not impose a requirement of medical necessity in order for a prescriber to prescribe a private label lens for which no namebrand equivalent exists.458 The Act also does not expressly contemplate the imposition of disclosure requirements on manufacturers. Therefore, the Commission is not implementing the recommendations of LD Vision Group. The Act and the Rule expressly require that, for private label contact lens prescriptions, prescribers include ‘‘trade name of equivalent brand name.’’ 459 Prescribers violate the Rule if they provide a script that omits this information because the script does not meet the definition of a contact lens prescription. With that in mind and given the additional information provided by LD Vision Group, the Commission will consider whether enforcement action is appropriate. VII. ‘‘Directly or by Facsimile’’ Language Includes Use of Online Patient Portals to Present Prescriptions Section 315.5(a)(1) of the Rule provides that a seller may sell contact lenses in accordance with a prescription that is presented to the seller ‘‘directly or by facsimile.’’ In the NPRM, the Commission initially determined that the provision ‘‘directly or by facsimile’’ includes the use of online patient portals by patients and prescribers to present contact lens prescriptions to 458 SNPRM, 81 FR 88551. In the SNPRM, the Commission also referenced the initial rulemaking, where sellers recommended that prescribers be required, when prescribing private label contact lenses, to identify on the prescription the name of a brand that a consumer could purchase from a seller other than the prescribing office. 69 FR 40503. The Act does not limit, in any way, the brand that a prescriber must select, and the current record does not have sufficient evidence indicating that this is a problem. Id. Therefore, LD Vision Group’s proposal to limit prescribers from prescribing private label brands without a brandequivalent is not adopted. 459 15 U.S.C. 7610, 16 CFR 315.2 (contact lens prescription defined to include, in the case of a private label contact lens, the name of the manufacturer, trade name of the private label brand, and, if applicable, trade name of equivalent brand name). E:\FR\FM\17AUR2.SGM 17AUR2 50702 Federal Register / Vol. 85, No. 159 / Monday, August 17, 2020 / Rules and Regulations sellers.460 The Commission noted that use of a patient portal ‘‘necessarily involves ‘an exact copy of the prescription within the scope of acceptable direct presentation mechanisms.’ ’’ 461 The Commission observed in the NPRM that technology had evolved since the Rule’s implementation in 2004 and that patient portals offered several potential benefits, including reducing: The chance of an inaccurate or expired prescription being presented to a seller; the costs for prescribers, patients, and sellers by making it easier and more efficient for patients to share and present prescriptions; and the number of verification requests to prescribers.462 The Commission sought comments on whether the use of online portals complies with the Rule and requested information about whether the Commission should consider any other issues related to the presentation of prescriptions to sellers. Although the Commission received many comments indicating that patients are able to receive their prescriptions electronically, including through patient portals, and interact with their prescribers electronically,463 few comments addressed the use of portals to present prescriptions directly to sellers. Commenters agreed that such technology could offer benefits, including reducing the number of requests for verification and additional copies, and giving patients greater access to their prescriptions.464 460 NPRM, 461 Id. 81 FR at 88537–38. at 88538. 462 Id. 463 See, e.g., Eklund (WS Comment #502); Reed (WS Comment #749); Gitchell (WS Comment #759); Andrews (WS Comment #1014); Carvell (WS Comment #1021); Cecil (WS Comment #1892); Kuryan (WS Comment #3472); Hopkins (NPRM Comment #184); Wilson (NPRM Comment #1310); Grove (NPRM Comment #1702); MacDonald (NPRM Comment #2118); Andrus (NPRM Comment #3345); American Academy of Ophthalmology (NPRM Comment #3657) (‘‘For practices that utilize electronic medical record systems, patients can request a copy of their prescription and [be] issued one electronically.’’); Coalition for Contact Lens Consumer Choice (SNPRM Comment #89). 464 National Association of Optometrists and Opticians (NPRM Comment #3851) (noting that the option to provide a prescription through a portal should be available because technology will continue to advance); 1–800 CONTACTS (NPRM Comment #3898); Costco Wholesale Corp. (NPRM Comment #4281) (supporting the FTC’s determination regarding presentation of prescriptions directly or by facsimile for the reasons cited in the NPRM); NPRM, 81 FR at 88538 (identifying the potential benefits of using a portal to present a prescription to a seller). Other commenters have expressed the potential benefits of portals or electronic health records generally. See, e.g., Information Technology & Innovation Foundation (SNPRM Comment #103); Opticians Association of Americas (WS Comment #482); Marshall (WS Comment #518) (suggesting the VerDate Sep<11>2014 20:17 Aug 14, 2020 Jkt 250001 However, it is unclear how often, if at all, prescribers send prescriptions to sellers through a portal. Use of portals to transmit prescriptions to sellers could face barriers, including technology issues between the parties caused by using different software and platforms, and privacy restrictions preventing sellers from accessing patients’ portal accounts.465 The Act and Rule clearly envision and support the use of electronic means to provide prescriptions. Section 7601(a)(2) of the Act requires prescribers to ‘‘provide or verify the contact lens prescription by electronic or other means’’ to patients’ agents.466 As discussed in the NPRM, it would be inconsistent for the Rule to permit prescribers to provide prescriptions electronically to patients, but not allow prescribers to provide a prescription electronically to a seller.467 Use of electronic medical records has increased in the health field generally,468 and many prescribers already use electronic methods to communicate with patients, including through patient portals.469 Given the benefit of electronic medical records in allowing easier access to the prescription); McCarty (WS Comment #1898); CooperVision, Inc. (WS Comment #3077); Coalition for Contact Lens Consumer Choice (WS Comment #3239) (stating that new technologies like electronic health records have benefits for consumers). 465 Hill (WS Comment #1361); McCarty (WS Comment #1898); Shum (WS Comment #543) (stating that ‘‘[t]he use of patient portals to send Rx would be unreliable due to inconsistent EHR [(electronic health records)] software and that some doctors do not have EHR’’); National Hispanic Medical Association (SNPRM Comment #146) (stating that creating a portal to share prescription information could be a burden on prescribers and patients); 1–800 CONTACTS (NPRM Comment #3898) (stating that ‘‘to the extent prescribers use portals to provide sellers with prescriptions, their portal should have the ability to send the prescription to the seller directly by email, text, or facsimile, and a seller should not be required to develop direct communication links to the portal’’); CLR Panel V Tr., supra note 191, at 19–20. 466 15 U.S.C. 7601(a)(2); 16 CFR 315.3(a)(2). 467 NPRM, 81 FR at 88538. 468 One survey from 2017 found that 52% of individuals were offered online access to their medical records by a health provider or insurer, an increase from 42% in 2014. Of those patients who were offered online access, more than half actually viewed their online medical records at least once in the past year. U.S. Dep’t of Health & Human Servs., The Office of the National Coordinator for Health Information Technology, ‘‘Individuals’ Use of Online Medical Records & Technology for Health Needs’’ 1–2 (2018). Furthermore, in 2013, 57% of prescriptions nationally were sent electronically from physicians to pharmacies, with the rate in some states over 80%. U.S. Dep’t of Health & Human Servs., The Office of the National Coordinator for Health Information Technology, ‘‘EPrescribing Trends in the United States’’ 8 (2014). 469 American Optometric Association (SNPRM Comment #96) (stating that approximately 47.5% of optometrists used electronic health records with a patient portal in their practice); National PO 00000 Frm 00036 Fmt 4701 Sfmt 4700 potential benefits, prescribers and patients should have the option to present a prescription to sellers through a patient portal when this method is available. Therefore, the Commission affirms its initial determination that the ‘‘directly or by facsimile’’ language includes the use of online patient portals by patients and prescribers to present contact lens prescriptions to sellers. VIII. Requests for an Additional Copy of a Prescription In the SNPRM, the Commission proposed requiring that prescribers who receive requests for additional copies of prescriptions from patients or their agents respond within forty business hours.470 The Commission believed that the forty-business-hour requirement was necessary to ensure that patients or their agents could receive additional copies of their prescription in a timely manner while recognizing that a shorter time period was unnecessary because patients would have already received a copy of their prescription after the contact lens fittings were completed and sellers could always submit a verification request.471 Additionally, prescribers would be required to note in the patient’s file the name of the requester and the date and time the prescription was provided. The Commission sought comment on whether prescribers should be required to respond within a certain time period, whether forty business hours was the appropriate time period, and what records, if any, prescribers should be required to keep to document the request and response.472 A. Benefits of an Additional Copy and the Time Period To Respond to a Request The AOA contends that Congress did not intend for sellers to be given authorization to serve as the patient’s agent.473 Rather, the AOA ‘‘assume[s] that Congress implemented this provision to account for cases in which a family member or caregiver needed authorization to obtain a patient’s Association of Optometrists and Opticians (SNPRM Comment #129) (‘‘Practice management systems and electronic health records (EHRs) with the capacity to allow patient portals, email, and text communication are easily available at reasonable prices to optometrists . . . .’’); National Hispanic Medical Association (SNPRM Comment #146); 1– 800 CONTACTS (NPRM Comment #3898). But see CLR Panel V Tr., supra note 191, at 17 (comment by a panelist that only 8% of his office’s patients used the portal). 470 SNPRM, 84 FR at 24684. 471 Id. 472 Id. 473 American Optometric Association (SNPRM Comment #96). E:\FR\FM\17AUR2.SGM 17AUR2 Federal Register / Vol. 85, No. 159 / Monday, August 17, 2020 / Rules and Regulations prescription.’’ 474 As noted in the NPRM, the Commission relied on the plain language of the Act and Rule to determine that sellers could serve as agents for patients,475 and the AOA does not point to any contrary evidence.476 Additionally, the AOA believes that no deadline to respond to requests for additional copies is necessary because prescribers take their responsibilities to their patients seriously.477 Other commenters supported the Commission’s proposal regarding requests for additional copies.478 Commenters noted that a deadline to respond would: (1) Make the process more predictable for patients and sellers, especially when involving a prescriber who has not responded to such requests in the past; 479 (2) potentially reduce the number of verification requests, which would benefit prescribers, sellers, and patients; and (3) improve the accuracy of information provided to sellers ensuring that patients receive the correct lenses.480 In addition to anecdotal 474 Id. 475 NPRM, 81 FR at 88536. In addition to sellers, the SNPRM noted that patients themselves could request an additional copy of the prescription. Although a commenter requested that the Commission modify the Rule to clarify that patients can request their own additional copy (National Association of Optometrists and Opticians (SNPRM Comment #129)), the Commission believes that the Rule’s language is sufficient and declines to make such change. SNPRM, 84 FR at 24684 n.259. 476 American Optometric Association (SNPRM Comment #96). 477 Id. The AOA also urged the Commission not to rely on 1–800 CONTACTS data indicating that only 46% of its requests for an additional copy of a prescription received a response because 1–800 CONTACTS may not have the patients’ consent to act as an agent. Although the Commission considered the 1–800 CONTACTS data, the Commission did not rely solely on this information when issuing its proposed Rule. SNPRM, 84 FR at 24669. 478 Citizen Outreach (SNPRM Comment #78); Lens.com (SNPRM Comment #85); Coalition for Contact Lens Consumer Choice (SNPRM Comment #89); Consumer Action (SNPRM Comment #101); Information Technology and Innovation Foundation (SNPRM Comment #103); National Association of Optometrists and Opticians (SNPRM Comment #129); Consumer Reports (SNPRM Comment #133); 1–800 CONTACTS (SNPRM Comment #135); American Academy of Ophthalmology (SNPRM Comment #136); Attorneys General of 27 States (SNPRM Comment #139). 479 Although not always the case, some sellers expressed difficulties with obtaining responses from prescribers. See National Association of Optometrists and Opticians (SNPRM Comment #129) (stating that at least one NAOO member reported receiving timely responses while other members found that it was ‘‘difficult, if not impossible, to get any form of a timely response’’). 480 Coalition for Contact Lens Consumer Choice (SNPRM Comment #89); National Association of Optometrists and Opticians (SNPRM Comment #129); Consumer Reports (SNPRM Comment #133); 1–800 CONTACTS (SNPRM Comment #135); Attorneys General of 27 States (SNPRM Comment #139); Contact Lens Association of Ophthalmologists (NPRM Comment #4259). VerDate Sep<11>2014 20:17 Aug 14, 2020 Jkt 250001 accounts of prescribers not responding to requests for additional copies, 1–800 CONTACTS commented that, in 2019 to date, it had received a response to approximately 52% of its requests for an additional copy with 82% of the responses being received within fortyeight hours of the request.481 This 2019 data is similar to 1–800 CONTACTS’ 2016 data, which showed that 46% of the requests received a response and 90% of those responses were received within two days.482 In response, the AOA questions 1–800 CONTACTS’ 2016 data because patients, who gave consent through a prechecked box, may not have intended for 1–800 CONTACTS to act as their agent in requesting the prescription.483 The AOA posits that prescriber concern over patients’ consent ‘‘may have impacted responses to [1–800 CONTACTS’] requests,’’ but offers no evidence to support this argument.484 Likewise, the AOA did not provide any data showing the extent to which prescribers have responded to requests for additional copies. Given the potential benefits and the aforementioned data, the Commission does not believe it is sufficient to rely simply on the expectation that all prescribers would fulfill their responsibilities to their patients. Rather, the Commission believes that the Rule should be amended to add a deadline to respond to a request for an additional copy. Although some commenters agreed that the Commission’s proposed deadline of forty business hours was a reasonable length of time,485 other commenters urged the Commission to use a shorter period, such as one business day 486 or twenty-four business hours,487 because (1) patients would want a quicker response, (2) the longer time period could undercut a benefit of using a prescription—reducing the number of verification requests, and (3) prescribers could be confused between forty business hours for an additional 481 1–800 CONTACTS (SNPRM Comment #135). CONTACTS (NPRM Comment #3898). 483 American Optometric Association (SNPRM Comment #96). 484 Id. 485 Coalition for Contact Lens Consumer Choice (SNPRM Comment #89); American Optometric Association (SNPRM Comment #96) (noting that if a deadline were added, forty business hours would be reasonable); Information Technology and Innovation Foundation (SNPRM Comment #103); 1–800 CONTACTS (SNPRM Comment #135); American Academy of Ophthalmology (SNPRM Comment #136). 486 Consumer Reports (SNPRM Comment #133). 487 National Association of Optometrists and Opticians (SNPRM Comment #129) (supporting a shorter time limit, in part, because the burden of complying could be lower due to portal, text, or email use). 482 1–800 PO 00000 Frm 00037 Fmt 4701 Sfmt 4700 50703 copy request and eight business hours for a verification request.488 Additionally, the work involved for a prescriber’s office to respond to a request would not increase with a shorter deadline.489 Although patients would benefit from a shorter response period, the Commission recognizes the additional stress on prescribers of having less time to respond, even if the work involved to complete a response remains the same. Because patients should have already received a copy of their prescription after the fitting,490 sellers can submit a verification request to complete the sale more quickly,491 and prescribers have an obligation to respond to a request for an additional copy, unlike a verification request, the Commission declines to make any further changes and will adopt the proposed forty-business-hour period. B. Requirement To Maintain Records Finally, as to what records, if any, a prescriber should be required to maintain regarding the request for an additional copy, the AOA believes that sellers, not prescribers, should shoulder this burden because sellers are ‘‘leveraging the patient agent provision to obtain patient prescriptions.’’ 492 Records of the request and the response would allow the Commission to monitor compliance.493 However, the Commission does not believe requiring the requestor to maintain such information would be appropriate because the obligation under the Rule to respond to prescription requests rests with prescribers and they would be in the best position to maintain records.494 Importantly, the Rule allows ‘‘any person designated to act on behalf of the patient[,]’’ including the patients themselves, family members, or caregivers, to request a copy of a prescription, not just sellers.495 A shift of the recordkeeping burden to any 488 National Association of Optometrists and Opticians (SNPRM Comment #129); Consumer Reports (SNPRM Comment #133). 489 Consumer Reports (SNPRM Comment #133). 490 16 CFR 315.3(a)(1). 491 16 CFR 315.5(a)(2). 492 American Optometric Association (SNPRM Comment #96). 493 The proposed Rule would mandate that prescribers make notations of the required information in their records, but would not require that they keep specific documentation. SNPRM, 84 FR at 24698. However, prescribers could choose to keep documentation of the request and response if they preferred. 494 See also National Association of Optometrists and Opticians (SNPRM Comment #129) (‘‘We believe it will be straight-forward and simple for the prescriber to keep a record of receiving the request for a copy and noting how and when the prescriber responded.’’). 495 SNPRM, 84 FR at 24684 n.259, 24698. E:\FR\FM\17AUR2.SGM 17AUR2 50704 Federal Register / Vol. 85, No. 159 / Monday, August 17, 2020 / Rules and Regulations designated agent making a request would not allow for effective monitoring because the Commission might need to obtain records from a wide variety of agents in order to determine whether a particular prescriber is complying with the Rule. Thus, the Commission declines to change the recordkeeping requirement. In conclusion, the Commission adopts the changes proposed in the SNPRM to require that prescribers respond to requests for an additional copy of a prescription within forty business hours and note in the patient’s record the name of the requestor and the date and time that the prescription was provided in response. IX. Excessive Quantity In the NPRM, the Commission declined to make any changes regarding the number of lenses that a consumer can purchase with a prescription.496 Several commenters had expressed concerns that consumers were able to obtain more than a year’s supply of contact lenses, often by purchasing more than a year’s worth at one time or by refilling their prescription just before the expiration date.497 However, the Commission determined that there was insufficient evidence on the record to support a limit on the maximum quantity of lenses that consumers can purchase prior to the prescription’s expiration.498 Although there was some evidence that patients purchased contact lenses just before their prescriptions expired, this evidence did not show that the quantity of lenses being purchased was excessive or that consumers were skipping eye exams.499 Furthermore, the Commission believed that a maximum quantity limit would be difficult to administer and could have a more significant negative effect on consumers who, instead of following the recommended replacement schedule, opt to wear their lenses longer until they see a prescriber.500 In response to the NPRM, some commenters supported the Commission’s decision not to impose 496 NPRM, 81 FR at 88549. at 88547–48. at 88548–49. The Commission also declined to modify the Rule to state that contact lens prescriptions are valid for an unlimited quantity of lenses regardless of any prescriberimposed limitation. The Commission found no evidence that prescribers were using quantity limits to undercut the prescription length and recognized that some state laws or regulations mandated that quantity information be included on a prescription, or that a prescriber may choose to do so. NPRM, 81 FR at 88549–50. However, prescribers cannot use quantity limits as a way to frustrate the Rule’s prescription expiration requirements. Id. at 88550. 499 Id. 500 Id. 497 Id. 498 Id. VerDate Sep<11>2014 20:17 Aug 14, 2020 Jkt 250001 quantity limits 501 while others expressed concerns about the purchase of excessive quantities and advocated for limits.502 The commenters who support quantity limits are concerned that patients who purchase excessive quantities of lenses face increased health risks because they do not see their prescriber as often.503 Contrary to the Commission’s position in the NPRM, they believe that there is evidence in the record that consumers are purchasing an excessive number of lenses close to the end of their prescription and that a quantity limit can be implemented.504 These commenters point to survey evidence by Johnson & Johnson Vision Care showing that consumers, in response to reminders that their prescriptions would be expiring soon, ordered more lenses.505 However, the concern is not whether consumers are purchasing lenses near the end of their prescription, but whether they are purchasing excessive quantities. As noted in the NPRM, the Johnson & Johnson Vision Care survey did not ask about the quantity of lenses purchased by consumers.506 The Commission had previously found that consumers typically do not purchase a year’s supply of lenses at one time.507 Additionally, 1–800 CONTACTS stated that it was aware of survey evidence it 501 Coalition for Contact Lens Consumer Choice (NPRM Comment #3718); Consumer Action (NPRM Comment #3721); 1–800 CONTACTS (NPRM Comment #3898). 502 See, e.g., Contact Lens Institute (SNPRM Comment #79); Goodman (WS Comment 599); Hanen (WS Comment #712); Dillehay (WS Comment #822); Rosenblatt (WS Comment #841); Hooven (WS Comment #1366); Henry (WS Comment #2194); Robson (WS Comment #2210); Wiechmann (WS Comment #2823); Health Alliance for Patient Safety (WS Comment #3206); Alcon Laboratories, Inc. (WS Comment #3339); Ellenbecker (WS Comment #3353); Jeun (NPRM Comment #1774); Daza (NPRM Comment #2002); Silva (NPRM Comment #3072); CooperVision, Inc. (NPRM Comment #3841); Coalition for Patient Vision Care Safety (NPRM Comment #3883); see CLR Panel IV Tr., supra note 121, at 19 (statement of David Cockrell). 503 Jeun (NPRM Comment #1774); Daza (NPRM Comment #2002); CooperVision, Inc. (NPRM Comment #3841); Coalition for Patient Vision Care Safety (NPRM Comment #3883). 504 CooperVision, Inc. (NPRM Comment #3841); Coalition for Patient Vision Care Safety (NPRM Comment #3883). 505 CooperVision, Inc. (NPRM Comment #3841) (stating that evidence of the high number of patients being contacted in the last days of their prescription ‘‘provides a powerful inference that sales in many situations are excessive’’); Coalition for Patient Vision Care Safety (NPRM Comment #3883). 506 NPRM, 81 FR at 88549–50; see also Johnson & Johnson Vision Care, Inc. (RFC Comment #582) (asking consumers whether a seller notified them that their prescription was expiring and whether they have ever ordered lenses within a month of their prescription’s expiration). 507 NPRM, 81 FR at 88549. PO 00000 Frm 00038 Fmt 4701 Sfmt 4700 believed showed that six months is the average size of an order made during the last thirty days of a prescription, which is similar to, based on 1–800 CONTACTS internal data, the average quantity ordered throughout the duration of the prescription.508 Thus, the Commission does not have sufficient basis to conclude, despite anecdotal reports and alleged practices by some sellers, that consumers are purchasing lenses in excessive quantities near the end of their prescription.509 Neither does the Commission have sufficient evidence showing that consumers are going to eye care providers less frequently because they previously purchased large quantities of contact lenses. In fact, evidence suggests that a majority of consumers are seeing their eye care provider regularly. One survey found that contact lens wearers have an eye exam every thirteen months on average while another survey showed that about 56% of respondents received an eye exam every twelve months or less, with an overall average of approximately sixteen months.510 These surveys appear consistent with a prior survey by the Coalition for Patient Vision Care Safety, which found that 87% of contact lens wearers had an eye exam last year.511 Some commenters also believe that a quantity limitation would not be difficult to implement when the seller has the prescription because sales could be limited to the amount of lenses necessary for the remaining period of the prescription or based on typical usage.512 However, it would be impractical for sellers to determine whether the quantity of lenses being purchased is necessary or typical because such amounts may not be the same for all consumers. Additionally, as noted in the NPRM, there are legitimate reasons why a consumer may want to purchase a supply of lenses that exceeds the remaining period of the 508 1–800 CONTACTS (NPRM Comment #3898) (stating that for a monthly contact lens the standard package size is six months, which is the minimum quantity available). 509 NPRM, 81 FR at 88549. 510 1–800 CONTACTS (NPRM Comment #3898). 511 NPRM, 81 FR at 88549 n.308. 512 Contact Lens Institute (SNPRM Comment #79) (stating that the ‘‘health and safety of patients requires limits on the sale of quantities of contact lenses beyond those reasonably required for patient use during the remaining term of a prescription’’ and urging that a verification request for a prescription that is close to expiration be treated as an alteration because it seeks to dispense excessive quantities of lenses); Coalition for Patient Vision Care Safety (NPRM Comment #3883) (stating that ‘‘when the seller has the prescription, no sale should exceed a supply of lenses necessary to last the remaining period of the prescription’’); CooperVision, Inc. (NPRM Comment #3841). E:\FR\FM\17AUR2.SGM 17AUR2 Federal Register / Vol. 85, No. 159 / Monday, August 17, 2020 / Rules and Regulations prescription, including having enough lenses until the next scheduled appointment, having replacements for lost or torn lenses, or replacing lenses more frequently.513 Additionally, quantity limitations could encourage some consumers to stretch out their lens supply by wearing them longer than recommended, which is a welldocumented health issue that outweighs the potential harm of patients purchasing a quantity of lenses that exceeds what is strictly anticipated by the remaining length of the prescription.514 Although it is possible that patients could purchase large quantities of lenses by presenting their prescription to multiple sellers, the Commission does not have evidence about the extent of such practice.515 Finally, when verification is used, a prescriber can determine whether the quantity ordered is excessive, and, if it is, inform the seller within the eightbusiness-hour period that the request is inaccurate and specify the appropriate amount of lenses.516 In conclusion, the Commission declines to modify the Rule to limit the quantity of lenses that consumers can purchase. X. Expiration of Contact Lens Prescriptions Section 315.6(a) of the Rule requires that a prescription expire on the date specified by the law of the state in which the prescription was written, if that date is one year or more after the issue date of the prescription.517 The Rule also provides that a prescription shall not expire less than one year after the issue date of the prescription, unless the prescriber specifies a shorter period that is ‘‘based on the medical judgment of the prescriber with respect to the ocular health of the patient’’ and documents the reasoning for the shorter expiration period in the patient’s medical record.518 The NPRM addressed comments requesting that the Commission set a longer minimum length for prescriptions, prohibit expirations on certain prescriptions, or leave prescription length to the sole discretion of the provider.519 However, because the Rule’s provisions closely track the Act, which sets a minimum expiration date ‘‘to prevent prescribers from selecting a short expiration date . . . that unduly limits the ability of consumers to purchases contact lenses’’ and because the Commission concluded that, in drafting the Act, Congress intended to defer to state law except where such law establishes a period of less than one year, the Commission stated that the current framework is appropriate and declined to make changes.520 The NPRM also addressed prescriber reports of patients obtaining contact lenses through sellers, especially online sellers, with expired contact lens prescriptions.521 Commenters requested a Rule change or greater enforcement of the Rule to deal with this problem.522 However, finding that the Rule sufficiently prohibited the use of expired prescriptions, the Commission declines to amend the Rule.523 Likewise, the AOA and the Contact Lens Institute supported the Commission maintaining the Rule’s current prescription length provisions.530 After reviewing the comments, the Commission again declines to modify or remove the Rule’s prescription length provisions. The current Rule closely tracks the Act, which Congress mandated, and already contains provisions that allow for prescriptions longer than one year, dependent upon state law, and shorter than one year, when those are appropriate based on the medical judgment of the prescriber, ensuring flexibility.531 The Commission does not find the record adequately supports lengthening the Rule’s prescription expiration provisions. Therefore, the Commission declines to alter the Rule’s provisions relating to prescription length. A. Length of Contact Lens Prescriptions Following the NPRM’s discussion of expiration length, the Commission received additional comments that favored making prescriptions valid for more than one year.524 Some commenters advocated for such change because they believed that prescriptions rarely change 525 or that consumers would save money if they needed to obtain exams less often.526 Other commenters expressed concern that shorter prescription expirations may have the undesirable result of encouraging consumers to wear contacts for longer than recommended 527 or that there should not be a standard minimum expiration in the Rule due to variations in patient needs.528 However, some manufacturer and prescriber organizations favored maintaining the Rule’s current expiration provisions. Johnson & Johnson Vision Care stated that the current Rule ‘‘ensures that patients continue to receive the vital professional oversight to decrease avoidable risks and increases patient access to the latest technologies to best meet their vision care needs.’’ 529 B. Sales Using Expired Contact Lens Prescriptions 520 Id.; see also 15 U.S.C. 7604. 81 FR at 88546–47. 521 NPRM, 522 Id. 513 NPRM, 81 FR at 88549; 1–800 CONTACTS (NPRM Comment #3898). 514 NPRM, 81 FR at 88549. See also 1–800 CONTACTS (NPRM Comment #3898) (citing survey data showing that 65% of participants tended to wear their last pair of contact lenses longer than when they have a supply of lenses). 515 NPRM, 81 FR at 88550. 516 16 CFR 315.5(d); Contact Lens Rule, 69 FR at 40501; NPRM, 81 FR at 88550 n.313. 517 16 CFR 315.6(a)(1). 518 16 CFR 315.6(a)(2)–(3); 16 CFR 315.6(b)(1). 519 NPRM, 81 FR at 88546. VerDate Sep<11>2014 20:17 Aug 14, 2020 Jkt 250001 50705 523 Id. at 88547. (WS Comment #2); Williams (WS Comment #1036); Yenovkian (WS Comment #1362); Yuen (NPRM Comment #1854); Susswein (NPRM Comment #3759). 525 Radcliffe (WS Comment #2); Williams (WS Comment #1036). 526 Williams (WS Comment #1036); Yuen (NPRM Comment #1854). 527 Berenguer (WS Comment #111). 528 Moss (WS Comment #837). 529 Johnson & Johnson Vision Care, Inc. (NPRM Comment #4327). Peter Menziuso, President of 524 Radcliffe PO 00000 Frm 00039 Fmt 4701 Sfmt 4700 After the NPRM, commenters again raised the issue of sellers selling contact lenses past the prescription expiration dates,532 and some argued that additional regulation is needed.533 The Rule already makes clear that expired prescriptions are invalid and prohibits JJVCI, also echoed this sentiment at the workshop, stating that the company feels strongly about maintaining the one-year expiration to assure patients are seeing their prescriber regularly and prioritizing health. See CLR Panel IV Tr., supra note 121, at 16. 530 Contact Lens Institute (SNPRM Comment #79); American Optometric Association (NPRM Comment #3830). 531 16 CFR 315.6(a)(2)–(3); 16 CFR 315.6(b)(1). 532 See, e.g., Hanian (SNPRM Comment #27); Pirozzolo (SNPRM Comment #33); Wilkes (SNPRM Comment #86); AOA (SNPRM Comment #96); Parikh (SNPRM Comment #152); Fuller (WS Comment #531); McBride (WS Comment #630); Swindell (WS Comment #682); Hamilton (WS Comment #781); Caywood (WS Comment #788); Matus (WS Comment #1534); Malaski (WS Comment #3160); DiGirolamo (NPRM Comment #23); Endry (NPRM Comment #29); Ross (NPRM Comment #48); Hanen-Smith (NPRM Comment #154); Weisz (NPRM Comment #963); Helwig (NPRM Comment #2349); Simpson (NPRM Comment #2896); Holle (NPRM Comment #3214); Gordon (NPRM Comment #3544); Reinstein (NPRM Comment #3560); Sheffer (NPRM Comment #3577). 533 Kepley (SNPRM Comment #76); Radford (NPRM Comment #59); Rodriguez (NPRM Comment #3896) (‘‘I was disappointed to learn that the FTC will not, under its existing authority, seek to morefully address the many unscrupulous business practices of online contact lens sellers that have been putting the health and safety of patients at risk for more than a decade. Expired contact lens prescriptions are regularly processed and filled by these online business.’’); Huang (NPRM Comment #2203); Avila (NPRM Comment #52); Hanen-Smith (NPRM Comment #154); Letter from Senator Heidi Heitkamp to Acting Chairwoman Maureen Ohlhausen (Jan. 5, 2018); Letter from Congressman Jeff Denham et al. to Chairman Joseph Simons (July 27, 2018). E:\FR\FM\17AUR2.SGM 17AUR2 50706 Federal Register / Vol. 85, No. 159 / Monday, August 17, 2020 / Rules and Regulations sales with such prescriptions.534 If a consumer presents the seller with an expired prescription, the seller cannot use it as the basis for the sale. Not only is the seller unable to base a sale on that expired prescription, but as the Commission clarified in the NPRM, a seller may not use an expired prescription as the basis for a verification request.535 If, however, a seller is presented with a prescription that lacks an expiration date,536 and that seller does not have knowledge as to whether the prescription is expired, the seller must verify the prescription with the prescriber prior to dispensing lenses. In this instance, the seller may rely on the prescriber to inform the seller if the prescription is expired.537 CooperVision requested that the Commission require that sellers, when not in possession of an unexpired prescription, ask consumers if their prescriptions have expired.538 In the NPRM, the Commission addressed a similar request by AOA to require sellers to include the expiration and issue dates, both required elements of a prescription, in verification requests.539 According to the AOA, this requirement would incentivize sellers to make sure patients know their prescription expiration date. However, as explained in the NPRM, the seller would not necessarily have the expiration or issue dates, and neither would the patient.540 A better source for this information is the prescriber, who has the ability to invalidate a prescription request because it is expired.541 For this reason, the Commission will not implement CooperVision’s proposal. Additionally, a number of prescriber organizations expressed concerns that consumers are able to buy lenses on expired prescriptions because of passive verification.542 Further, to lessen the 534 16 CFR 315.5(d). 81 FR at 88546–47. 536 16 CFR 315.2. 537 NPRM, 81 FR at 88547. 538 CooperVision, Inc. (SNPRM Comment #130). 539 NPRM, 81 FR at 88547 (citing AOA Comment #644). 540 NPRM, 81 FR at 88547. 541 As explained in the Alteration section, Section VI, supra, if a seller wishes to avail itself of the exception to alteration, it may use an expired prescription as an indication of manufacturer or brand if the minimum criteria discussed in that Section are met, and the seller obtains additional information, from the consumer or the prescriber, that the consumer has a current prescription for that brand. In so doing, the seller obtains a basis for the verification request other than the expired prescription. 542 Contact Lens Institute (SNPRM Comment #79) (‘‘Indeed, CLI remains concerned about the contribution of passive verification via robocalls to filling expired or invalid prescriptions . . .’’); American Society of Cataract and Refractive Surgery (SNPRM Comment #127) (‘‘Significant 535 NPRM, VerDate Sep<11>2014 20:17 Aug 14, 2020 Jkt 250001 chances of the sale of lenses after the expiration of a prescription, some commenters requested that the Commission require that prescriptions be presented at the time of the sale of lenses.543 As stated in Section V, Congress mandated passive verification, and requiring prescription presentation would be inconsistent with Congress’s intent. The Final Rule also includes several changes to automated verification calls that will improve passive verification by allowing prescribers to better identify requests based on expired prescriptions.544 Finally, commenters again requested that the Commission bring enforcement actions against sellers that sell lenses after the expiration of the prescription.545 As stated in the NPRM, if the Commission receives credible evidence that sellers are selling contact lenses when they have actual knowledge that the prescriptions are expired (either because they were presented with a copy of an expired prescription or received a response from a prescriber within the time frame specified in the Rule telling the seller that the prescription is expired), the Commission will take appropriate steps to investigate the allegations.546 XI. Paperwork Reduction Act The existing Rule contains recordkeeping and disclosure requirements that constitute ‘‘collection[s] of information’’ as defined by 5 CFR 1320.3(c) under Office of Management and Budget (‘‘OMB’’) regulations that implement the Paperwork Reduction Act (‘‘PRA’’), 44 U.S.C. 3501 et seq.547 On May 28, 2019, concerns with patient safety, as the current eighthour validation window allows inaccurate, falsified, and expired contact lens prescriptions to be filled. Subsequently, patients’ ocular health is put at risk because of a restricted validation period.’’); American Society of Cataract and Refractive Surgery (NPRM Comment #3820) (‘‘Many of our members practice in solo or small practices that often do not have the resources to respond to verification requests within the eight-hour time frame. This rule allows a seller to fill a prescription that is inaccurate, expired, or falsified simply because the prescriber has been unable to respond within eight hours. As a result, patients suffer serious eye injuries by wearing ill-fitted contacts.’’); Massachusetts Society of Eye Physicians and Surgeons (NPRM Comment #4270). 543 Sanders (SNPRM Comment #61); Wisniewski (NPRM Comment #1769); Hanian (NPRM Comment #153). 544 See Section III, supra. 545 Cooper Vision, Inc. (SNPRM Comment #130); Stout (WS Comment #450); Stolicker (NPRM Comment #10); Osetek (NPRM Comment #22); Bass (NPRM Comment #55); Coalition for Patient Vision Care Safety (NPRM Comment #3883); Letter from Congressman David Roe to Chairman Joseph Simons (Nov. 29, 2018). 546 NPRM, 81 FR at 88547. 547 On October 2, 2019, the Commission requested permission from OMB to continue these PO 00000 Frm 00040 Fmt 4701 Sfmt 4700 the Commission issued a SNPRM proposing amendments that would contain new information collection requirements subject to OMB review and approval. Specifically, the SNPRM estimated an additional recordkeeping burden for prescribers resulting from the proposed Rule modifications to 597,917 hours (85,417 hours regarding signatures + 512,500 hours regarding their retention) and the associated estimated annual labor cost burden of $13,244,727.548 On the same date, the Commission also submitted a request to OMB seeking approval for the new information collections associated with the proposed rulemaking. On September 20, 2019, the OMB directed the Commission to examine public comments relating to the proposed rulemaking and describe any public comments received regarding the collection, as well as why the Commission did or did not incorporate the commenter’s recommendation.549 Below, the Commission describes and discusses the amendments to the Final Rule, the public comments received relating to the collection of information burden associated with the SNPRM, and the Commission’s ultimate determination of the burden generated by the final amendments. The Commission has made a number of modifications to the Rule that contain recordkeeping requirements that are collections of information as defined by 5 CFR 1320.3(c). First, the Rule has been modified to require that prescribers either: (A) Obtain from patients, and maintain for a period of not less than three years, a signed confirmation of prescription release on a separate standalone document; (B) obtain from patients, and maintain for a period of not less than three years, a patient’s signature on a confirmation of prescription release included on a copy of a patient’s prescription; (C) obtain from patients, and maintain for a period of not less than three years, a patient’s signature on a confirmation of pre-existing information collections, which were estimated to be 2,104,050 annual hours of burden (which were derived by adding 1,045,650 disclosure hours for contact lens prescribers to 1,058,400 recordkeeping hours for contact lens sellers). See 84 FR 51162 (Sept. 27, 2019); Agency Information Collection Activities; Submission for OMB. On December 9, 2019, OMB approved the Rule’s existing information collection requirements through December 31, 2022. OMB Control No. 3804–0127. See 84 FR 51162 (Sept. 27, 2019); Agency Information Collection Activities; Submission for OMB Review; Comment Request. 548 See 84 FR at 24693–94 (May 28, 2019); Supplemental notice of proposed rulemaking; request for public comment. 549 OMB Control No. 3804–0127, ICR Reference No. 201910–3084–001, Notice of Office of Management and Budget Action (Sept. 10, 2019). E:\FR\FM\17AUR2.SGM 17AUR2 Federal Register / Vol. 85, No. 159 / Monday, August 17, 2020 / Rules and Regulations prescription release included on a copy of a patient’s contact lens fitting sales receipt; or (D) provide each patient with a copy of the prescription via online portal, electronic mail, or text message, and for three years retain evidence that such prescription was sent, received, or, if provided via an online-patient portal, made accessible, downloadable, and printable by the patient.550 For prescribers who choose to offer an electronic method of prescription delivery, the Final Rule requires that such prescribers identify the specific method or methods to be used, and maintain records or evidence of affirmative consent by patients to such digital delivery for three years.551 For instances where a consumer refuses to sign the confirmation or accept digital delivery of their prescription, the Final Rule directs the prescriber to note the refusal and preserve this record as evidence of compliance.552 None of these new requirements, however, would apply to prescribers who do not have a direct or indirect financial interest in the sale of contact lenses.553 Additional modifications to the Rule that constitute collections of information as defined by 5 CFR 1320.3(c) require that sellers who use calls containing automated verification messages: (1) Record the entire call; (2) commence the call by identifying it as a request for prescription verification; (3) provide the information required by § 315.5(b) in a slow and deliberate manner and at a reasonably understandable volume; and (4) give the prescriber the option to repeat the information.554 The call recordings must be preserved for at least three years.555 The Commission hereby provides PRA burden estimates, analysis, and discussion for the requirements to collect patient signatures as confirmation of prescription release and as consent to electronic prescription delivery; and the requirement to record automated verification messages; and associated recordkeeping obligations. A. Confirmation of Prescription Release and Affirmative Consent to Digital Delivery of a Prescription 1. SNPRM Burden Estimate for the Confirmation of Prescription Release In its SNPRM, the Commission put forth estimates for the additional burden on individual prescribers’ offices to generate and present to patients the 550 16 CFR 315.3(c)(1). CFR 315.2. 552 16 CFR 315.3(c)(1)(iii). 553 16 CFR 315.3(c)(3). 554 16 CFR 315.5(d). 555 16 CFR 315.5(h)(4). 551 16 VerDate Sep<11>2014 20:17 Aug 14, 2020 Jkt 250001 confirmations of prescription release, and to collect and maintain the confirmations of prescription release for a period of not less than three years.556 As set out in the PRA section’s introductory paragraph above, the Commission previously calculated this burden to be 597,917 hours (85,417 hours for prescribers to collect patient signatures and 512,500 hours for prescribers’ office staff to store them).557 Based on average hourly wage rates, the Commission calculated the aggregate labor cost burden (totaling prescribers and prescribers’ office staff) at $13,244,727.558 The Commission noted, however, that arguably, the overall burden of the Rule—including verification costs previously approved by the Office of Management and Budget 559—could be lower (or not increase) given the proposed modification’s potential offsetting effects of more patients being in possession of their prescriptions and consequently fewer verifications.560 The Commission requested comment on the accuracy of the FTC’s burden estimates, including whether the methodology and assumptions used are valid (such as whether prescribers or office staff are more likely to collect patient signatures and retain associated recordkeeping), and a quantification of the reduction in verifications resulting from the confirmation of prescription proposal.561 2. Comments Regarding the SNPRM Estimate for the Confirmation of Prescription Release Requirement In response to the Commission’s SNPRM proposal, several commenters reiterated that obtaining and storing the Confirmations of Prescription Release would create ‘‘onerous’’ administrative and financial burdens, but most commenters did not supply financial estimates for this burden.562 The AOA, which had previously estimated the cost of the NPRM’s signed-acknowledgment proposal to be as high as $18,795 per optometrist,563 did not submit a new 556 SNPRM, 84 FR at 24692. at 24693. 558 Id. at 24694. This estimate was based on a mean hourly wage of $57.26 for optometrists and $16.30 for office clerks. Economic News Release, U.S. Dep’t of Labor, Bureau of Labor Statistics, Table 1. National employment and wage data from the Occupational Employment Statistics survey by occupation, May 2017. 559 See note 549, supra. 560 SNPRM, 84 FR at 24693–94. 561 Id. 562 See Section II.C.7, supra. 563 American Optometric Association (NPRM Comment #3830). As noted in note 247, supra, the Commission explained in the SNPRM that it could not accord this estimate significant weight because 557 Id. PO 00000 Frm 00041 Fmt 4701 Sfmt 4700 50707 burden estimate for the Confirmation of Prescription Release proposal, but did opine that the increased flexibility of the new proposal would not reduce the overall burden on prescribers.564 One commenter estimated that it would cost his practice $10,000 per year in ‘‘paperwork, storage, and time spent by secretaries handling paperwork,’’ but did not provide details about his practice (the number of patients and prescribers, for instance) or how the estimate was derived, and what the cost amounted to on a per-patient or perprescription basis.565 Another commenter, Dr. Thomas Steinemann, wrote, ‘‘I dispute the FTC contention that each documentation will only take ‘one minute.’ Additional documentation can actually take several minutes when there are discrepancies in verification.’’ 566 Dr. Steinemann commented that according to his office manager, the ‘‘additional steps of verification and documentation’’ would add 10 minutes of administrative time per patient.567 The comment, however, does not articulate how the Confirmation of Prescription Release requirement can create discrepancies in verification, or what ‘‘additional steps of verification’’ Dr. Steinemann or his office manager are referring to. The Confirmation of Prescription Release requirement does not directly impact the requirement that prescribers verify prescriptions upon request, other than to potentially make such requests less common if more patients have possession of their prescriptions and can present them to sellers when ordering. In contrast to those critical of the burden and the Commission’s SNPRM PRA analysis, other commenters contended that the burden of the new requirement would be minimal or offset by a reduced burden in other respects of the Rule.568 One commenter, the ITIF, asserted that evidence that the new it was based not on the cost of the proposed Signed Acknowledgment but on the overall cost of government regulations (including those already in place), and because the survey had numerous methodological limitations. SNPRM, 84 FR at 24677. 564 American Optometric Association (SNPRM Comment #96). A few SNPRM commenters reiterated the AOA’s $18,000 estimate (which the Commission previously determined it could not rely on, for reasons explained in the SNPRM), 84 FR at 24677, but did not provide additional information or empirical support for this figure. Koerber (SNPRM Comment #110); American Society of Cataract and Refractive Surgery (SNPRM Comment #127). 565 Pierce (SNPRM Comment #17). 566 Steinemann (SNPRM Comment #65); Steinemann (SNPRM Comment #138). 567 Id. 568 See Section II.C.7, supra. E:\FR\FM\17AUR2.SGM 17AUR2 50708 Federal Register / Vol. 85, No. 159 / Monday, August 17, 2020 / Rules and Regulations requirement would increase prescriber costs ‘‘appears to be significantly overstated,’’ and noted that storing confirmation signatures in paper takes up ‘‘very little room and cost,’’ and, if stored electronically, storage costs are ‘‘essentially zero.’’ 569 The ITIF also stated allowing prescribers to deliver prescriptions digitally would reduce the ‘‘already small’’ burden on prescribers of the confirmation of release requirement, and at the same time reduce the number of verification calls from third party lens sellers, thus further reducing the overall burden on both sellers and prescribers.570 Another commenter, the National Taxpayers Union (‘‘NTU’’), felt the SNPRM burden-estimates were ‘‘plausible,’’ and noted that the FTC’s estimates were based on underlying assumptions that may be overly cautious, and thus lead to overcounting.571 In particular, the NTU noted that the Commission, in calculating the SNPRM’s PRA burden: (1) Assumed that only optometrists would obtain patient signatures, when, in fact, support staff—who are paid less per hour—are permitted to do so; (2) provided sample confirmation language so prescribers wouldn’t have to formulate their own; (3) assumed that every provider would spend a minute per confirmation even though states already impose recordkeeping requirements, and electronic storage might take seconds; and (4) did not account for potentially offsetting reductions in burden hours for eye care providers due to reduced time and effort spent responding to verification requests (since more patients would have possession of their prescriptions and be able to present them to thirdparty contact lens sellers).572 Likewise, 1–800 CONTACTS submitted a new analysis from Stanford Health Research Professor Laurence Baker that called the Commission’s burden analysis ‘‘conservative,’’ and estimated that a reduction in verification requests by 13–15% would 569 Information Technology & Innovation Foundation (SNPRM Comment #103). 570 Id. See also National Association of Optometrists and Opticians (SNPRM Comment #129) (stating that with more practitioners moving to practice management systems and electronic health records, digital delivery of contact lens prescriptions is a ‘‘very feasible’’ option for many prescribers, which will further reduce the burden of the confirmation requirement). 571 National Taxpayers Union (SNPRM Comment #149). 572 Id. See also National Association of Optometrists and Opticians (SNPRM Comment #129) (stating that with more patients in possession of their prescriptions, there would be fewer orders relying on the verification process). VerDate Sep<11>2014 20:17 Aug 14, 2020 Jkt 250001 be sufficient to offset all of the costs of the confirmation requirement.573 None of the SNPRM commenters offered detailed suggestions for reducing the burden resulting from the Confirmation of Prescription Release proposal, other than to suggest that the Commission withdraw its proposal completely or choose a substantially different alternative, such as signage or public education.574 For reasons discussed in Section II.C.6., supra, the Commission does not believe such alternatives would effectively serve the purpose of the Rule. 3. Estimated Additional Burden Hours for the Confirmation of Prescription Release Requirement Commission staff estimates the PRA burden of the Confirmation of Prescription Release requirement based on comments received and its longstanding knowledge and experience with the eye care industry.575 Staff continues to believe there will be an additional burden on individual prescribers’ offices to satisfy the confirmations of prescription release requirements, but that this burden will be relatively small in the context of the overall market for contact lenses and examinations.576 The number of contact lens wearers in the United States is currently estimated to be approximately 45 million.577 Therefore, assuming an annual contact lens exam for each contact lens wearer, the Confirmation of Prescription Release requirement would require that 45 million people either read and sign a Confirmation of Prescription Release or agree to receive their prescription electronically. Nothing in the comments to the SNPRM alters the Commission’s belief that generating and presenting the Confirmation of Prescription Release will not require significant time or effort. The comments describing the burden as crippling and onerous do not 573 1–800 CONTACTS (SNPRM Comment #135). Section II.C.6, supra. 575 See Section I.B., supra, discussing the Commission’s three decades of experience with the optical goods industry. 576 One survey estimated that the U.S. contact lens market totaled approximately $5,012,800,000 (not counting examination revenue) in 2017. ‘‘Vision Markets See Continued Growth in 2017, VisionWatch Says,’’ Vision Monday, March 20, 2018, http://www.visionmonday.com/business/ research-and-stats/article/vision-markets-seecontinued-growth-in-2017-visionwatch-says/. See also note 609 and accompanying text, infra. 577 Centers for Disease Control, Healthy Contact Lens Wear and Care, Fast Facts, https:// www.cdc.gov/contactlenses/fast-facts.html. This is an updated figure that represents an increase of four million wearers since the NPRM and SNPRM estimates were prepared. 574 See PO 00000 Frm 00042 Fmt 4701 Sfmt 4700 contain empirical facts or data regarding the amount of time and cost of the Commission’s proposal, and some estimates appear overstated. The Commission continues to believe that creating the Confirmation of Prescription Release should not be difficult to implement since the requirement is flexible in that it allows any one of several different modalities and delivery methods, including adding the confirmation to existing documentation that prescribers routinely provide (sales receipts) or are already required to provide (prescriptions) to patients. The requirement is also flexible in that it does not prescribe other details such as the precise content or language of the patient confirmation, but merely requires that, if provided to the patient pursuant to options specified in § 315.3(c)(1)(i)(A), (B), and (C), the confirmation from the patient must be in writing. At the same time, it is not required that prescribers spend time formulating their own content for the confirmation, since the Rule provides draft language that prescribers are free to use, should they so desire. Furthermore, the confirmation requirement is flexible enough to cover situations where a contact lens fitting is completed remotely, since a prescriber can readily satisfy the confirmation and prescription-release requirements by various methods, including email, text, or uploading the prescription to a patient portal, so long as the patient consents to such delivery. The four options for a prescriber to confirm a prescription release to a patient are set out in § 315.3(c)(1)(i)(A), (B), (C), and (D). The requirement in options (A), (B), and (C) to provide the patient with a Confirmation of Prescription Release statement are not disclosures constituting an information collection under the PRA because the FTC, in § 315.3(c)(1)(ii), has supplied the prescriber with draft language the prescriber can use to satisfy this requirement.578 As noted above, however, the requirement in (A), (B), and (C) to collect a patient’s signature on the Confirmation of Prescription Release and preserve it constitutes an information collection as defined by OMB regulations that implement the PRA. Nonetheless, the Commission believes it will require minimal time for a patient to read the confirmation and provide a signature. The Commission estimated in the SNPRM that it would 578 ‘‘The public disclosure of information originally supplied by the Federal government to the recipient for the purpose of disclosure to the public is not included within’’ the definition of ‘‘collection of information.’’ 5 CFR 1320.3(c)(2). E:\FR\FM\17AUR2.SGM 17AUR2 Federal Register / Vol. 85, No. 159 / Monday, August 17, 2020 / Rules and Regulations take patients ten seconds to read the one-sentence Confirmation of Prescription Release and provide a signature,579 and the Commission believes that ten seconds remains an appropriate estimate. The fourth option, § 315.3(c)(1)(i)(D), does not, in and of itself, constitute an information collection under the PRA, since no new information that would not otherwise be provided under the Rule is provided to or requested from the patient.580 Excluding that option from consideration, and assuming the remaining three options are exercised with equal frequency, 75% of approximately 45 million annual prescription releases will entail reading and signing a confirmation statement. Thus, assuming ten seconds for each release, prescribers and their office staff would devote 93,750 hours, cumulatively (75% × 45 million prescriptions yearly × 10 seconds each) to obtaining patient signatures as confirmations of prescription release.581 Maintaining those signed confirmations for a period of not less than three years should also not impose substantial new burdens on individual prescribers and office staff. The majority of states already require that optometrists keep records of eye examinations for at least three years,582 and thus many prescribers who opt to include the confirmation of prescription release on the prescription itself would be preserving that document, regardless. Similarly, most prescribers already retain customer sales receipts for 579 SNPRM, 84 FR at 24693. This estimate was based on responses to a consumer survey regarding how long it would take consumers to read the Signed Acknowledgment, and a prior PRA estimate for consumers to complete a similar signed acknowledgment. 580 In order to utilize § 315.3(c)(1)(i)(D), however, a prescriber must obtain and maintain records or evidence of affirmative consent by patients to electronic delivery of their prescriptions. 16 CFR 315.2. The burden to do so is included in the recordkeeping burden calculation of this PRA Section. 581 Section 315.3(c)(1)(iii) also requires that in the event that a patient declines to sign a confirmation requested under paragraphs (c)(1)(i)(A), (B), or (C), the prescriber must note the patient’s refusal on the document and sign it. However, the Commission has no reason to believe that such notation should take any longer than for the patient to read and sign the document, so the Commission will maintain its calculation as if all confirmations requested under (c)(1)(i)(A), (B), or (C) require the same amount of time. 582 See, e.g., 246 Mass. Code Regs. § 3.02 (requiring optometrists to maintain patient records for at least seven years); Wash. Admin. Code § 246– 851–290 (requiring optometrists to maintain records of eye exams and prescriptions for at least five years); Iowa Admin. Code r. 645–182.2(2) (requiring optometrists to maintain patient records for at least five years); Fla. Admin. Code r. 64B13–3.003(6) (requiring optometrists to maintain patient records for at least five years). VerDate Sep<11>2014 20:17 Aug 14, 2020 Jkt 250001 financial accounting and recordkeeping purposes, and thus prescribers who opt to include the confirmation of prescription release on the sales receipt also could be retaining that document, regardless. Moreover, storing a one-page document per patient per year should not require more than a few seconds, and an inconsequential, or de minimis, amount of record space. Some prescribers might also present the Confirmation of Prescription Release in electronic form, enabling patients to sign a computer screen or tablet directly and have their confirmation immediately stored as an electronic document. For other prescribers, the new recordkeeping requirement would likely require that office staff either preserve the confirmation in paper format, or electronically scan the signed confirmation and save it as an electronic document. For prescribers who preserve the confirmation electronically by scanning it, Commission staff estimates that saving such a document would consume approximately one minute of staff time. Commission staff does not possess detailed information on the percentage of prescribers’ offices that currently use and maintain paper forms, electronic forms, or that scan paper files and maintain them electronically. Thus, for purposes of this PRA analysis, Commission staff will assume that all prescriber offices who opt for § 315.3(c)(1)(i) (A), (B), or (C) require a full minute per confirmation for recordkeeping arising from the modifications. Excluding from PRA consideration the fourth option, § 315.3(c)(1)(i)(D), as there is no signature to obtain or retain, and assuming that prescribers elect the other options three-fourths or 75% of the time, the recordkeeping burden for all prescribers to scan and save such confirmations would amount to 562,500 hours (75% × 45 million prescriptions yearly × one minute for scanning and storing) per year. As noted previously, the fourth option for satisfying the Confirmation of Prescription Release requirement does not necessitate that prescribers obtain or maintain a record of the patient’s signature confirming receipt of her prescription. However, as explained in § 315.2, under the Rule’s now-modified definition of Provide to the patient a copy, in order to avail themselves of the fourth option, prescribers must obtain and maintain records or evidence of the patients’ affirmative consent to electronic delivery for three years. In order to remain as cautious as possible in estimating the burden, the Commission will use the assumption PO 00000 Frm 00043 Fmt 4701 Sfmt 4700 50709 that consumers sign such consents for electronic delivery pursuant to § 315.3(c)(1)(i)(D) for one quarter of the 45 million prescriptions released per year,583 and that this task would take the same amount of time as to obtain and maintain a signature of the patient’s Confirmation of Prescription Release. Thus, the Commission will allot 218,750 hours 584 for the time required for prescribers to obtain affirmative consents and maintain records of same. Therefore, the estimated incremental PRA recordkeeping burden for prescribers and their staff resulting from the Confirmation of Prescription Release modifications to the Rule amounts to 906,250 total hours ((93,750 and 31,250 hours, respectively, to obtain signatures confirming release and consenting to electronic delivery) plus (562,500 and 218,750 hours, respectively, to maintain such records for three years)). As some commenters noted, the overall burden of the Rule—particularly verification costs previously approved by the Office of Management and Budget 585—could lessen (or not increase by as much as the incremental burden from the proposed Rule modifications), given potentially offsetting effects presented by the Commission’s Rule modifications.586 With more patients in possession of their prescriptions (due to increased prescription release), and a greater ability to present them to sellers (due to the modification requiring sellers to provide a method for patients to present prescriptions) fewer time-consuming verifications would be necessary.587 Based on new projections from 1–800 CONTACTS 588 and a previous analysis by the Commission,589 a decrease of between 13%–23% in verifications could be sufficient to offset the entire cost of the Confirmation of Prescription Release requirement. In the SNPRM, however, the Commission noted that these estimates rely on a number of assumptions, not all of which are confirmed as accurate.590 Furthermore, (45 million prescriptions × 25%). hours (11,250,000 prescriptions yearly × 10 seconds) for obtaining the signature plus 187,500 hours (11,250,000 affirmative consents × one minute) for storing such records. 585 See note 549, supra. 586 See Information Technology & Innovation Foundation (SNPRM Comment #103); 1–800 CONTACTS (SNPRM Comment #135); National Taxpayers Union (SNPRM Comment #149). 587 Id. 588 1–800 CONTACTS (SNPRM Comment #135) (estimating that a reduction of 13%–15% in verifications would offset the estimated costs of the proposal). 589 SNPRM, 84 FR at 24693–94. 590 Id. at 24678. The calculation also does not take into account any of the benefit to consumers from 583 11,250,000 584 31,250 E:\FR\FM\17AUR2.SGM Continued 17AUR2 50710 Federal Register / Vol. 85, No. 159 / Monday, August 17, 2020 / Rules and Regulations neither 1–800 CONTACTS, nor any other commenter, provided empirical data or projections as to how much the number of verifications will decline due to the Rule modifications. The Commission continues to lack this data, and thus cannot predict whether the verification decrease—should it occur— would be sufficient to offset any or all of the burden. Therefore, the Commission will not make an adjustment for offsetting effects and benefits at this time. For this specific reason, and the various cautious assumptions described above, the Commission’s estimate of 906,250 total hours for prescribers and their staff resulting from the Confirmation of Prescription Release requirement may well overstate the burden of the modification. Furthermore, the actual burden should be even lower because none of the Confirmation of Prescription Release requirements apply to prescribers who do not have a direct or indirect financial interest in the sale of contact lenses. The Commission requested but did not receive comment on the percentage of prescribers who might be exempt, and does not currently possess sufficient information to determine what percentage of prescribers do not have a financial interest in the sale of contact lenses. The Commission thus has not reduced the estimated PRA burden accordingly at this time. 4. Estimated Total Labor Cost Burden for the Confirmation of Prescription Release Modification Commission staff derives labor costs by applying appropriate hourly-cost figures to the burden hours described above. The task to obtain patient confirmations and consent to electronic delivery could theoretically be performed by medical professionals (e.g., optometrists, ophthalmologists) or their support staff (e.g., dispensing opticians, medical technicians, office clerks). In the SNPRM, the Commission requested comment as to whether prescribers or office staff are more likely to collect patient signatures and retain associated recordkeeping, but did not receive significant guidance on this. Therefore, staff will continue to assume that optometrists will perform the task of collecting patient signatures, and staff will perform the labor pertaining to having their prescriptions and being able to choose from among competing sellers; the savings consumers might achieve by purchasing lowerpriced lenses; the improvements to health and safety due to a reduction in errors associated with invalid prescriptions currently verified through passive verification; and the Commission’s ability to assess and verify compliance with the Rule. VerDate Sep<11>2014 20:17 Aug 14, 2020 Jkt 250001 printing, scanning, and storing of documents, even though this may lead to some overcounting of the burden. According to the Bureau of Labor Statistics, salaried optometrists earn an average wage of $57.68 per hour, and general office clerks earn an average wage of $16.92 per hour.591 Using the aforementioned estimate of 125,000 total prescriber labor hours for obtaining patient signatures, the resultant aggregate labor costs to obtain patient signatures is $7,210,000 (125,000 hours × $57.68). As previously noted, Commission staff assumes that office clerks will typically perform the labor pertaining to the printing, scanning and storing of prescription release confirmations. Applying a mean hourly wage for office clerks of $16.92 per hour to the aforementioned estimate of 781,250 hours, cumulative labor costs for those tasks would total $13,218,750. Therefore, combining the aggregate labor costs for both prescribers and office staff to obtain signed patient confirmations and consent to electronic delivery and preserve the associated records, the Commission estimates the total labor burden of the Confirmation of Prescription Release modification to be $20,428,750. This represents an increase from the SNPRM’s estimated burden for the Confirmation of Prescription Release proposal due to a relatively large increase in the number of contact lens wearers now estimated by the Centers for Disease Control,592 increases in the estimated wages of optometrists and office staff by the Bureau of Labor Statistics,593 and the additional Rule modification requiring prescribers to collect and preserve patients’ affirmative consent to electronic delivery of their prescriptions. 5. Capital and Other Non-Labor Costs for the Confirmation of Prescription Release Requirement The proposed recordkeeping requirements detailed above regarding prescribers impose negligible capital or other non-labor costs, as prescribers likely have already the necessary equipment and supplies (e.g., prescription pads, patients’ medical charts, scanning devices, recordkeeping storage) to perform those requirements. 591 Press Release, Bureau of Labor Statistics, United States Department of Labor, Occupational Employment Statistics—May 2018, https:// www.bls.gov/news.release/ocwage.t01.htm. 592 Centers for Disease Control, Healthy Contact Lens Wear and Care, Fast Facts, https:// www.cdc.gov/contactlenses/fast-facts.html. 593 Press Release, Bureau of Labor Statistics, United States Department of Labor, Occupational Employment Statistics—May 2018, https:// www.bls.gov/news.release/ocwage.t01.htm. PO 00000 Frm 00044 Fmt 4701 Sfmt 4700 B. Recording of Automated Telephone Messages As noted above, the Commission has further modified the Rule to require that sellers who use automated verification messages record the calls and preserve the recordings for three years. In the SNPRM, the Commission staff did not put forth a specific burden estimate for this requirement, but rather sought comments to help inform such estimated burden, to the extent applicable.594 The Commission received a few comments stating that the requirement presented a burden for sellers.595 1–800 CONTACTS, for instance, commented that the requirement to store the recorded calls would impose a costly new burden while providing relatively few associated benefits.596 Consumer Reports essentially reiterated this view.597 None of the commenters, however, provided data or cost figures that would help inform the Commission’s estimated burden. The Commission does not believe that requiring sellers who use automated telephone messages for verification to record the calls and preserve the recordings will create a substantial burden. The requirement will not require additional labor time for sellers, since the verification calls will be for the same duration that they are now (the length of time required to submit the information required for verification under § 315.5 (b)). However, the new requirement will likely require capital and other non-labor costs to record the calls and store them electronically. But sellers who utilize automated telephone messages for verification are already availing themselves of sophisticated communication technology, and thus should not find it daunting to implement technology to record such calls. Meanwhile the growth of digital recording technology, and the capital investment required for recording equipment and record storage, is rapidly declining and has been for some time.598 A phone service provider used by at least one online contact lens seller, for example, advertises that it charges a quarter of one cent ($.0025) for each minute recorded, plus a storage fee of $.0005-per-month for each minute of 594 SNPRM, 84 FR at 24694. Sections III.B., C. and D, supra. 596 1–800 CONTACTS (SNPRM Comment #135). 597 Consumer Reports (SNPRM Comment #133). 598 See Final Rule, Telemarketing Sales Rule, 68 FR 4622 (Jan. 29, 2003) (discussing the cost for recording calls, and determining it was not a significant obstacle for telemarketers). 595 See E:\FR\FM\17AUR2.SGM 17AUR2 Federal Register / Vol. 85, No. 159 / Monday, August 17, 2020 / Rules and Regulations recorded storage over 10,000.599 In other words, assuming each verification call requires three minutes of recording, the first 3333 verification calls recorded and stored would cost $25 (three-fourths of one cent per call),600 and each additional verification call would cost approximately six cents apiece to record and store for three years.601 Other phone service providers surveyed advertise call-recording options such as $4.99 per gigabyte (about 5000 minutes) of recorded calls (about 4/10th of a cent per verification call),602 and 1000 minutes of call recording for $14.95 (approximately 4.5 cents per verification call).603 Some services also advertise unlimited call-recording plans ranging anywhere from $20–70 a month, depending on how many lines, and how much storage is required.604 The costs of these services would vary depending on what other options are selected, how long storage is required, and the size of the order, among other things, and the Commission does not vouch for the sufficiency of any of these services. Rather, the Commission mentions these advertised promotions to demonstrate that the cost of recording calls does not appear to be burdensome. Moreover, the Commission believes, as stated in Section III, supra, that any incremental costs to sellers for recording calls is outweighed by the benefit to consumers and prescribers from curtailing invalid verification calls. For purposes of calculating the PRA burden, however, the Commission will estimate that each three-minute verification call costs five cents to record. According to recent survey data, approximately 36% of contact lens purchases are from a source other than the prescriber.605 Assuming that each of the 45 million contact lens wearers in the U.S. makes one purchase per year, this would mean that approximately 16,200,000 contact lens purchases (45 599 Twilio Support, https://support.twilio.com/hc/ en-us/articles/223132527-How-much-does-it-costto-record-a-call-. 600 (10,000 minutes × $.0025) ÷ 3333 three-minute calls = $.0075 per call. 601 Id. For each additional three-minute verification call, it would cost three-quarters of a cent to record and .15 of a cent per month to store the recording (5.4 cents for 36 months), for a total of 6.15 cents per call. 602 https://getvoip.com/blog/2017/11/16/callrecording/; see also https://jive.com/features/callrecording (estimating that one gigabyte typically stores about 5,000 minutes of recorded calls). 603 https://www.phone.com/pricing-all/. 604 https://www.avoxi.com/blog/best-callrecording-service/. 605 Jason J. Nichols & Deborah Fisher, ‘‘2018 Annual Report,’’ Contact Lens Spectrum, Jan. 1, 2019, https://www.clspectrum.com/issues/2019/ january-2019; VisionWatch, Contact Lenses, September 2019. VerDate Sep<11>2014 20:17 Aug 14, 2020 Jkt 250001 million × 36%) are made annually from sellers other than the prescriber. Based on prior discussions with industry, approximately 73% of sales by nonprescriber sellers require verification, meaning that approximately 11,826,000 purchases would require verification calls, faxes, or emails (16,200,000 × 73%). The Commission does not possess information as to the percentage of verifications completed by telephone versus fax or email. Thus for purposes of this analysis, the Commission will assume that all verifications are performed via telephone. Furthermore, the Commission does not have information as to the percentage of telephone verifications that are automated as opposed to live calls, and thus will assume that all telephone verifications are automated calls and subject to the new call-recording requirement. Based on the aforementioned assumptions, the Commission estimates that the requirement to record automated telephone messages will require recording 11,826,000 calls 606 at an annual cost to third-party sellers, in the aggregate, of $591,300 (11,826,000 × $.05). C. Total Burden for the Modifications to the Rule Combining the marginal cost of the Rule modifications for both sellers and prescribers, the Commission estimates that the amendments will impose an additional burden of $21,020,050 ($20,428,750 for prescribers + $591,300 for third-party sellers). Adding these estimated costs to the OMB’s already approved existing cost burden ($84,548,448) results in a total PRA burden from the Rule of $105,568,498. While not insubstantial, this represents just two percent of the overall $5,012,800,000 contact lens market in the United States.607 Moreover, as noted previously, the estimated burden is calculated using several cautious assumptions that may overstate the actual cost; in all likelihood, the actual burden will be significantly less. 606 In some instances, sellers may have to call more than once to verify an order. In those instances, however, only the recording of the successful verification would need be preserved. 607 ‘‘Vision Markets See Continued Growth in 2017, VisionWatch Says,’’ Vision Monday, March 20, 2018, http://www.visionmonday.com/business/ research-and-stats/article/vision-markets-seecontinued-growth-in-2017-visionwatch-says/. See also, Steve Kodey, US Optical Market Eyewear Overview, 4, https://www.ftc.gov/sites/default/files/ filefield_paths/steve_kodey_ppt_presentation.pdf. PO 00000 Frm 00045 Fmt 4701 Sfmt 4700 50711 XII. Regulatory Flexibility Act The Regulatory Flexibility Act (‘‘RFA’’) 608 requires that the Commission provide an Initial Regulatory Flexibility Analysis (‘‘IRFA’’) with a Proposed Rule, and a Final Regulatory Flexibility Analysis (‘‘FRFA’’) with the Final Rule, unless the Commission certifies that the Rule will not have a significant economic impact on a substantial number of small entities.609 The purpose of the regulatory flexibility analysis is to ensure that the agency considers the impact on small entities and examines regulatory alternatives that could achieve the regulatory purpose while minimizing burdens on small entities. Although the Commission believed that the amendments it proposed would not have a significant economic impact on small entities, it included an IRFA in the SNPRM and solicited public comment.610 In this section, the Commission discusses the SNPRM comments that addressed the IRFA,611 as appropriate, below. The Final Rule is similar to the rule proposed in the SNPRM. The Commission continues to believe that the amendments it is adopting will not have a significant economic impact upon small entities, but has nonetheless deemed it appropriate as a matter of discretion to provide this FRFA. A. Need for and Objectives of the Rule Amendments The Commission’s Final Rule incorporates changes affecting prescribers and sellers. These changes were, in large part, previously addressed in the Commission’s NPRM and SNPRM, including in the Regulatory Flexibility Act sections. As explained in the earlier IRFAs, the need for and objective of these changes is to clarify 608 5 U.S.C. 601–612. U.S.C. 603–605. 610 SNPRM, 84 FR at 24694. The Commission’s NPRM also included an IRFA. NPRM, 81 FR at 88588. 611 Unlike many other commenters who addressed the IRFA indirectly, the AOA commented on the RFA by name stating its belief that the Commission ‘‘has not fully considered the regulatory burden under which physicians are already operating’’ and cited to the Office of Advocacy of the U.S. Small Business Administration’s FY 2018 Report on the Regulatory Flexibility Act. According to the AOA, that report stated that ‘‘[s]mall businesses have told advocacy stories that exemplify how federal regulations drain small businesses’ resources, energy, and in some cases even their desire to stay in business.’’ The AOA indicated that it ‘‘has heard the same concerns voiced by doctors of optometry who after years of service in patient care find that the regulatory framework is so intrusive to the doctor patient relationship, [sic] that some consider leaving the profession.’’ SNPRM Comment #96. 609 5 E:\FR\FM\17AUR2.SGM 17AUR2 50712 Federal Register / Vol. 85, No. 159 / Monday, August 17, 2020 / Rules and Regulations and update the Rule in accordance with marketplace practices. 1. Amendments Affecting Prescribers The following changes affect prescribers, many of whom are small businesses: (1) Should the prescriber so choose, allow for electronic delivery of prescriptions as a means for automatic prescription release when agreed to by the patient (and in such cases, prescribers must retain evidence for not less than three years that the prescription was sent, received, or made accessible, downloadable, and printable). The prescriber must identify to the patient the specific method of electronic delivery and obtain the patient’s consent to that method, and maintain the evidence of consent for a period of not less than three years; (2) Request the patient sign a confirmation of receipt of a contact lens prescription (and if a patient declines to sign, must note the patient’s refusal on the document and sign it); 612 and (3) Respond to authorized seller requests for copies of a prescription within forty business hours, and require the prescriber to make a notation in the patient’s record when responding to such requests. As explained in detail in this Final Rule notice, the Commission has determined that a Confirmation of Prescription Release is necessary for several reasons, including: (1) Multiple consumer surveys consistently show prescriber non-compliance with, and lack of consumer awareness of, the Rule’s prescription-release requirement; (2) numerous personal accounts of prescribers’ failure to release prescriptions; (3) the persistently high number of verifications, many of which would be unnecessary were consumers in possession of their prescriptions; (4) the regulatory structure of the contact lens market, which requires a consumer to obtain lenses pursuant to a prescription while permitting prescribers to sell what they prescribe, thus creating an incentive for prescribers to withhold prescriptions; and (5) the lack of credible empirical evidence rebutting or contradicting the evidence that prescribers are not automatically releasing prescriptions, and that consumers are not fully aware of their rights.613 The Commission further determined that allowing prescribers to satisfy the automatic prescription release requirement by using an online patient 612 This requirement does not apply to prescribers who do not have a direct or indirect financial interest in the sale of contact lenses. 613 See Section II, supra. VerDate Sep<11>2014 20:17 Aug 14, 2020 Jkt 250001 portal or other electronic method in lieu of a paper copy, when the patient gives verifiable affirmative consent, offered benefits for sellers, prescribers, and patients. Patients would be able to access their prescriptions and have electronic copies to send to sellers. With the prescription, a seller would no longer need to submit a verification request, which would also benefit prescribers by reducing the volume of requests.614 The Commission is also instituting a forty-business-hour requirement for prescribers to provide additional copies of prescriptions upon request from a patient’s agent to ensure that patients or their agents can receive additional copies of their prescription in a timely manner.615 Additionally, prescribers would be required to note in the patient’s file the name of the requester and the date and time the prescription was provided so that the Commission is able to determine, if necessary, whether a prescriber has complied with the Rule. 2. Amendments Affecting Sellers The amendments affecting sellers require them: (1) When using automated telephone messages to verify prescriptions, to record the entire call (and maintain such recordings for a period of not less than three years), commence the call by identifying it as a request for prescription verification made in accordance with the Contact Lens Rule, deliver the required information in a slow and deliberate manner and at a reasonably understandable volume, and make the required information repeatable at the prescriber’s option; (2) to provide consumers with a method that allows consumers to submit their prescriptions to sellers; and (3) to verify only the contact lens brand or manufacturer that appears on the consumer’s prescription, unless the consumer has provided an unprescribed contact lens manufacturer or brand in response to a specific request from the seller. The Commission implemented the additional requirements for automated verification calls to relieve the burden on prescribers and reduce potential health risks to patients from incomplete or incomprehensible automated telephone messages. Specifically, the Commission noted that prescribers must be able to understand automated messages so they can, if necessary, respond to sellers to prevent improper sales. The Commission imposed the 614 For a more detailed analysis of the reasons the Commission allowed prescribers to satisfy the automatic release requirement electronically in the Final Rule, see Section II.C.5., supra. 615 See Section VIII, supra. PO 00000 Frm 00046 Fmt 4701 Sfmt 4700 amendments in response to concerns about the quality of automated telephone messages, and instated the recording requirement because without such a record, the Commission cannot reliably assess whether a call was compliant, and further, whether the seller has a pattern of placing noncompliant calls (and unlawfully selling after such calls). The Commission also imposed a requirement for sellers to accept prescription presentation to reduce the number of verifications, reduce errors associated with incorrect verification attempts, and make it more difficult for ill-intentioned sellers to abuse the passive verification framework and take advantage of consumers who might not realize that the seller intends to verify a different lens than the one written on their prescription. The Commission modified the definition of alteration, and included an exception for sellers that verify only the contact lens brand or manufacturer that consumers indicate is on their prescriptions in order to address the emergence of several businesses that rely exclusively, or almost exclusively, on passive verification as a means to substitute their own brand of contact lenses for those originally prescribed by the patient’s prescriber. The Commission continues to receive reports about the proliferation of passive verification abuses. The implementation of the alteration definition, including the exception, should serve as an effective deterrent against sellers that try to game the verification system to sell non-prescribed contact lenses.616 B. Significant Issues Raised by Public Comments in Response to the IRFA, Including Any Comments Filed by the Chief Counsel for Advocacy of the Small Business Administration, and the Agency’s Response, Including Any Changes Made in the Final Rule Amendments The Commission did not receive any comments from the Small Business Administration on this Rule Review. The Commission did receive comments from various interested parties in response to the SNPRM, and it discusses them below. 1. Amendments Affecting Prescribers As discussed in detail in this notice, the Commission, in the SNPRM, determined that the Rule needs to contain some form of patient confirmation requirement, but the Commission made changes to its prior 616 The reasons for this Final Rule amendment are more fully discussed in Section VI, supra. E:\FR\FM\17AUR2.SGM 17AUR2 Federal Register / Vol. 85, No. 159 / Monday, August 17, 2020 / Rules and Regulations signed-acknowledgment proposal (put forth in the NPRM) in an effort to reduce the burden associated with, and address other criticisms surrounding, the proposal. These changes included: (1) Adding an option for prescribers to satisfy the confirmation requirement by releasing the prescription electronically under certain conditions; (2) excluding from the requirement eye care prescribers who have no direct or indirect financial interest in the sale of contact lenses; and (3) allowing prescribers to craft their own wording of the signed confirmation, while providing sample confirmation language that prescribers can use at their discretion.617 In response to the SNPRM proposal, the Commission received a number of comments, mostly from prescribers, criticizing, and detailing the burden of, and other issues associated with complying with, the Commission’s Confirmation of Prescription Release requirement.618 Other SNPRM commenters provided new views or concerns about the NPRM’s proposal to require that prescribers respond to requests from patients or their agent for an additional copy of a prescription within forty business hours. Some commenters felt that the Commission should not impose a time period for prescribers to respond to requests from patients or their agents for an additional copy of a prescription. Other commenters recommended that the Commission require prescribers to respond to such requests within a shorter period of time. The Commission has determined that a defined time period is necessary, and that its SNPRM proposal of forty business hours should be sufficient to ensure prescribers comply within a reasonable amount of time, while at the same time limit the additional burden on them to do so.619 2. Amendments Affecting Sellers In response to the SNPRM’s proposal to require that each verification call: commence by identifying it as a request for prescription verification made in accordance with the Contact Lens Rule; deliver the required information in a slow and deliberate manner and at a reasonably understandable volume; and make the required information repeatable at the prescriber’s option, the Commission did not receive any comments suggesting that this resulted 617 In the Final Rule, for instances where a patient refuses to sign the confirmation, the Commission directs the prescriber to note the refusal and preserve this record as evidence of compliance. 618 See Section II, supra. 619 These commenters’ concerns and the Commission’s response to such concerns are addressed more fully in Section VIII, supra. VerDate Sep<11>2014 20:17 Aug 14, 2020 Jkt 250001 in a burden. Some commenters did raise objections, however, to the Commission’s recording requirement, as discussed in detail in Section III.C., supra. For the reasons discussed in that Section and reiterated in A.2. of this Section, the Commission determined to retain the recording requirement. The Commission did not receive any comments opposing the SNPRM’s proposal requiring that sellers provide a method of, and a disclosure of the method of, prescription presentation. The Commission did receive a comment, however, suggesting that the Commission require that the method to present prescriptions be in close proximity to the option to provide the parameters of the contact lens for verification. Although the Commission did not impose that requirement, it took that comment into account in determining that, to maximize the potential benefit from the amendment, the seller must provide and disclose the method for the patient to present the seller with a copy of the patient’s prescription prior to requesting a prescriber’s contact lens prescription. In addition, the Commission, in response to comments addressing the issue, provided more guidance on the methods that sellers need to use (i.e., the method by which the order is taken or email, text or file upload). The Commission also received comments on the SNPRM’s proposed modification defining alteration, and providing an exception to alteration for sellers that verify only the brand or manufacturer that consumers indicate is on their prescription. Some commenters felt the modification was unnecessary, and that other Rule changes were adequate to curb the practices of substitution to non-prescribed brands through use of the verification system. As addressed in Section VI.B., supra, the Commission has determined that there are benefits to retaining this modification. In response to comments, however, the Commission provided additional guidance on the acceptable methods for obtaining brand and manufacturer information. C. Description and Estimate of the Number of Small Entities to Which the Amendments Will Apply or Explanation Why No Estimate Is Available Prescribers of contact lenses are affected by the amendments concerning the option for electronic delivery of prescriptions as a means for automatic prescription release, Confirmation of Prescription Release, and the imposition of a forty-business-hour time frame for responding to authorized requests for additional copies of prescriptions. There PO 00000 Frm 00047 Fmt 4701 Sfmt 4700 50713 are approximately 43,000 optometrists and 16,700 ophthalmologists in the United States,620 though not all optometrists and ophthalmologists would be affected by the amendments since some do not prescribe contact lenses. Some prescribers who prescribe contact lenses also would not be affected by the Confirmation of Prescription Release requirement if they do not have a direct or indirect interest in the sale of contact lenses. Of the contact lens prescribers who are affected by the modifications, the Commission— based on its knowledge of the eye-care industry—believes that many fall into the category of small entities (e.g., offices of optometrists with less than $7.5 million in average annual receipts).621 Determining a precise estimate of the number of small entities covered by the Rule’s prescriptionrelease requirements is not readily feasible, however, because most prescribers’ offices are private entities that do not release the underlying revenue information necessary to make this determination.622 The Commission sought comment in its SNPRM regarding the estimated number or nature of such small business entities, if any, for which the proposed amendments would have a significant impact, and did not receive commenter guidance in return. Non-prescriber sellers of contact lenses are affected by the amendments concerning the additional requirements for using an automated telephone verification message, requirements to accept prescription presentation, and requirements to verify only the contact lens brand or manufacturer that consumers indicate is on their prescriptions.623 Based on its knowledge of the industry, staff believes that the number of these entities that likely qualify as small businesses (less than $22 million in average annual receipts) is not likely to be substantial.624 620 See note 269, supra. U.S. Small Business Admin., ‘‘Table of Small Business Size Standards Matched to North American Industry Classification System Codes,’’ (eff. Feb. 26, 2016), https://www.sba.gov/sites/ default/files/files/Size_Standards_Table.pdf. 622 5 U.S.C. 601(6). 623 Most prescribers who sell lenses do so after fitting the patient with the prescribed lens, and thus do not rely on prescription verification. The amendments affecting sellers pertain to verification or prescription presentation and do not pertain to these sales. As a result, the Commission does not consider prescribers in its estimated burden for the proposals affecting sellers. 624 See U.S. Small Business Admin., ‘‘Table of Small Business Size Standards Matched to North American Industry Classification System Codes’’ (Aug. 19, 2019), https://www.ecfr.gov/cgi-bin/text621 See E:\FR\FM\17AUR2.SGM Continued 17AUR2 50714 Federal Register / Vol. 85, No. 159 / Monday, August 17, 2020 / Rules and Regulations D. Description of the Projected Reporting, Recordkeeping and Other Compliance Requirements of the Amendments, Including an Estimate of the Classes of Small Entities That Will Be Subject to the Requirement and the Type of Professional Skills Necessary for Preparation of the Report or Record 1. Amendments Affecting Prescribers The Confirmation of Prescription Release amendment requires that prescribers with a direct or indirect interest in the sale of contact lenses request that patients sign, and maintain for a period of not less than three years, either (A) a statement confirming receipt of the contact lens prescription; (B) a prescriber-retained copy of a contact lens prescription that contains a statement confirming receipt of the contact lens prescription; or (C) a prescriber-retained copy of the receipt for the examination that contains a statement confirming receipt of the contact lens prescription. As an alternative to (A), (B), and (C), under certain conditions, prescribers can provide a contact lens prescription digitally. In order to avail themselves of this option, prescribers must maintain, for a period of not less than three years, evidence that the prescriptions were sent, received, or made accessible, downloadable and printable. In addition, the prescriber must identify to the patient the specific method or methods of electronic delivery to be used, such as text message, electronic mail, or an online patient portal, obtain the patient’s verifiable affirmative consent to receive a digital copy through the identified method or methods, and maintain records or evidence of a patient’s affirmative consent for a period of not less than three years. The small entities potentially covered by these amendments will include all such entities subject to the Rule. The professional skills necessary for compliance with the Rule as modified will include office and administrative support supervisors to create the language and format of the confirmation, and clerical personnel to collect signatures from patients and maintain records, or in the case of digital prescriptions, retain evidence that the prescription was sent, received, or made accessible, downloadable and printable and retain evidence of a patient’s affirmative consent. Compliance may include some minimal training time as well. The Commission has provided language that prescribers idx?SID=b919ec8f32159d9edaaa36a7eaf6b695 amp;mc=true&node=pt13.1.121&rgn=div5# se13.1.121_1201. VerDate Sep<11>2014 20:17 Aug 14, 2020 Jkt 250001 can use for the Confirmation of Prescription Release which, should a prescriber elect to use such language, negates the burden of formulating appropriate language. The Commission believes the overall burden imposed on small businesses by these requirements is relatively small, for the reasons described previously in Section II.C.7. of this notice. That section also addresses in detail the comments received, which discuss the burden from this amendment. The amendment relating to providing a designated agent with an additional copy of a prescription requires that the prescriber respond within forty business hours of receipt of the request, and note in the patient’s record the name of the requester and the date and time that the prescription was provided to the requester. The professional skills necessary for compliance with this amendment will include office and administrative support staff to respond to the request within forty business hours. Previously, office and administrative support staff were already required to respond to such requests, just not within a specific time frame. The forty-business-hour time period, in and of itself, should not impose a significant new burden. The office and administrative support staff will also need to make the required notations in the patient’s records. As noted, the required notation would be limited to the name of the requester and the date and time the prescription was provided to the requester. Although the Rule does not require that prescribers retain the notations, the Commission expects prescribers would make and retain such notations in the ordinary course of their business and thus believes the proposal would not create much, if any, additional burden. 2. Amendments Affecting Sellers To the extent, if any, that nonprescriber sellers are small entities, the amendments relating to changes in verifications made through automated telephone messages require sellers to record the entire call, commence the call by identifying it as a request for prescription verification made in accordance with the Rule, deliver the information in a slow and deliberate manner and at a reasonably understandable volume, and make the information repeatable at the prescriber’s option. Sellers must retain the complete call recording of such automated telephone messages for at least three years. The Commission believes that most small sellers who are covered by the Rule, if any, are unlikely to have PO 00000 Frm 00048 Fmt 4701 Sfmt 4700 undergone or to undergo the expense associated with creating and maintaining an automated telephone system for verification requests.625 Instead, the Commission believes that small sellers typically comply with the Rule by receiving copies of prescriptions from patients, or making verification requests to prescribers via fax, email, or telephone calls using ‘‘live’’ agents. If a small seller already has an automated system for verification, the Commission does not believe the costs to accommodate the changes would be more than minimal, if any. For a seller who was following the FTC’s prior guidance that automated messages be delivered at a volume and cadence that a reasonable person can understand,626 it already complies with the new proposal that all such messages be at a ‘‘reasonably understandable volume’’ and delivered in a ‘‘slow and deliberate manner.’’ Similarly, if not already in compliance, a seller might need to modify its model verification recording to identify at the start that a call is being made in accordance with the Contact Lens Rule and to make the required information repeatable at the prescriber’s option. The Commission also has little reason to believe that the new requirement that sellers who use automated messages record such calls and retain them for no less than three years creates a substantial burden for small sellers. The Commission’s SNPRM invited comment on the frequency with which small sellers use automated telephone messages for verification and the costs associated with the proposals pertaining to these messages, including whether existing verification systems include the capability to record and the capacity for storage, and the costs associated with recording the calls and maintaining the recordings for no less than three years. The Commission received little guidance in response. 1–800 CONTACTS, a large contact lens seller, stated the proposal to record and store these calls imposes a ‘‘costly’’ burden, but did not detail the costs associated with recording and maintaining the calls. The Commission’s own research surrounding such costs for recording phone calls does not support this contention.627 And as noted above, the 625 1–800 CONTACTS also believes this to be the case. See 1–800 CONTACTS (SNPRM Comment #135) (stating that the number of sellers that use this particular technology is likely limited). 626 Prior guidance from the FTC directed sellers to deliver verification messages at a volume and cadence that a reasonable person can understand. See note 301, supra. 627 See PRA discussion of the cost of recording calls, Section XI.B., supra. E:\FR\FM\17AUR2.SGM 17AUR2 Federal Register / Vol. 85, No. 159 / Monday, August 17, 2020 / Rules and Regulations number of sellers that employ this technology is limited, and the Commission does not believe that small sellers use or are likely to use automated messages for verification calls. The new requirement that sellers provide a method, and a clear and prominent disclosure of the method, for the consumer to present the seller with a copy of the patient’s prescription also does not impose a large burden on small sellers. A small seller would need to update its website or other consumer interface to inform consumers about the ability to provide the seller with a prescription, or alternatively, if an order occurs via telephone or in person, to verbally inform the consumer about the ability to provide the seller with a prescription. The professional skill or time necessary for this task would include personnel with the skills required to update the website or other consumer interface, and the time it takes to make the updates, or if the information is relayed over the phone or in person, the additional time for an employee or agent of the seller to inform a consumer that he or she is able to provide a prescription, and of the method by which a consumer can do so. These proposals may also require training time for staff. The seller would also need to provide a mechanism for a consumer to provide the prescription to the seller. Because a small seller almost certainly already has the capacity to accept prescriptions via an existing electronic system or email account, the Commission believes there is little additional burden of complying with this part of the proposal. The small seller would also need to maintain prescriptions it receives via patient presentation. The Commission has not received any comments that alter its understanding that such retention does not create more than a minimal burden. Further, by retaining a patient’s prescription, a seller is relieved of the burden to verify that prescription or maintain records of verification. As a result, the burden from obtaining and retaining prescriptions likely offsets the burden from making verification requests and storing records of such requests. Both the FCLCA and the Rule prohibit illegal alteration of a prescription. The modification of the Rule’s definition of alteration would clarify what constitutes alteration, and permit sellers to avail themselves of an exception by verifying only the contact lens brand or manufacturer that consumers indicate is on their prescriptions when asked by the seller. As a result, all non-prescriber sellers that qualify as small businesses would need to request and obtain VerDate Sep<11>2014 20:17 Aug 14, 2020 Jkt 250001 manufacturer or brand information via website or other consumer interface, telephone, or in person to qualify for the exception. The professional skill or time necessary for this task would include personnel with the skills required to update the website or other consumer interface and the time it takes to make the updates, or if the information is relayed over the phone or in person, the additional time for an employee or agent of the seller to obtain the information. Such employees would also need to be trained on this requirement. Although there is no associated document retention requirement set forth in the Rule, the Commission is aware that without the evidence that the manufacturer or brand provided on the verification request was the one provided by the customer, the seller would not be able to avail itself of the exception to illegal alteration. As a result, the Commission has considered the associated document retention as a new burden. However, since many contact lens sales by non-prescriber sellers occur online, the burden of such record retention may be minimized by the ability to keep electronic sales records. For sales that occur via telephone or in person, the seller would be required to maintain records of the request made by, and the information supplied by, the consumer. The Commission believes that sellers retain phone-order records in the ordinary course of business and any additional recordkeeping sellers may do to qualify for the exception is likely to be minimal. E. Steps Taken To Minimize the Significant Impact, if Any, of the Amendments, Including Why Any Significant Alternatives Were Not Adopted 1. Steps and Alternatives for Amendments Affecting Prescribers The Commission considered a number of alternatives to the requirement for prescribers to request the patient sign a confirmation of receipt of a contact lens prescription, including signage and educating consumers about their rights to a contact lens prescription. The Commission determined that signage would be significantly less effective than a Confirmation of Prescription Release requirement. It also determined that consumer education in itself, whether provided via information entry forms, a patients’ bill of rights, advertising, or public service announcements, would not have a significant impact on prescriber compliance with automatic prescription release, and would not increase the Commission’s ability to PO 00000 Frm 00049 Fmt 4701 Sfmt 4700 50715 monitor and enforce the Rule.628 In response to commenter concerns about its proposal as outlined in the NPRM and SNPRM, the Commission took steps to minimize the impact of the Confirmation of Prescription Release. First, the Commission included an option for prescribers to satisfy the confirmation by releasing the prescription electronically. While not every prescriber will be able to use this option to deliver a prescription electronically, the Commission is confident that this option will still reduce the burden for many, especially as more prescribers move toward electronic recordkeeping. Second, the Commission excluded from the requirement eye care prescribers who have no direct or indirect financial interest in the sale of contact lenses. By more narrowly targeting the requirement to only those with an incentive to withhold prescriptions, the Commission further reduced the overall burden and avoided unnecessarily impacting prescribers who are unlikely to violate the Rule. Third, the Commission reduced the burden by allowing a significant degree of flexibility in how prescribers comply with the confirmation requirement. The Final Rule allows prescribers to craft their own wording for statements confirming receipt of contact lens prescriptions (on a stand-alone statement, on a prescriberretained copy of a prescription, or on a prescriber-retained copy of an examination receipt), while providing sample language for prescribers to use, should they not wish to formulate their own confirmation. This change reduces the possible paperwork burden and limits potential interference with the prescriber-patient relationship.629 In considering the amendment requiring prescribers to respond to requests for copies of a prescription within a defined period (forty business hours), the Commission considered, but rejected, the option to simply rely on the expectation that all prescribers would fulfill their responsibilities to their patients. It is the Commission’s understanding that prescribers do not always comply, or comply expediently, and therefore believes the time-limit requirement is necessary. In order to minimize the burden on prescribers, however, the Commission rejected 628 These alternatives and the reasons the Commission found them to be insufficient alternatives to Confirmation of Prescription Release are more fully described in Section II.C.6., supra, of this notice. 629 In the Final Rule, for instances where a patient refuses to sign the confirmation, the Commission directs the prescriber to note the refusal and preserve this record as evidence of compliance. E:\FR\FM\17AUR2.SGM 17AUR2 50716 Federal Register / Vol. 85, No. 159 / Monday, August 17, 2020 / Rules and Regulations commenter requests to make the time limit significantly shorter, such as eight business hours. As for the new requirement that prescribers make a notation in the patient’s record when responding to such requests, the Commission declined to shift the recordkeeping burden to the designated agent making a request because, to determine whether a particular prescriber is complying with the Rule, the Commission would need to obtain records from a wide variety of agents. 2. Steps and Alternatives for Amendments Affecting Sellers The Commission did not consider specific alternatives to the Final Rule’s requirement that sellers, when using automated telephone messages to verify prescriptions, commence the call by identifying it as a request for prescription verification made in accordance with the Contact Lens Rule, deliver the required information in a slow and deliberate manner and at a reasonably understandable volume, and make the required information repeatable at the prescriber’s option.630 The Commission included these amendments in the Final Rule to relieve the burden on prescribers and reduce potential health risks to patients from incomplete or incomprehensible automated telephone messages. Specifically, the Commission noted that prescribers must be able to understand automated messages so they can, if necessary, respond to sellers to prevent improper sales. Commenters presented additional suggestions to improve call quality, but did not suggest alternatives to commencing the call by identifying it as a request for prescription verification made in accordance with the Contact Lens Rule, and to make the required information repeatable at the prescriber’s option, nor did they express opposition to such requirements. The Commission considered whether to require sellers to retain a sample recording of the standard script leaving blanks for prescription and patient details instead of recording all calls using automated telephone messages. However, the Commission determined that a script or a sample recording would not reveal whether the required information was transmitted effectively or if, for instance, it was transmitted before a representative or machine answered, after an answering machine cut off, when a prescriber’s office put 630 The requirements that the seller deliver the required information in a slow and deliberate manner and at a reasonably understandable volume have been part of the FTC’s prior guidance that the information be delivered at a volume and cadence that a reasonable person can understand. VerDate Sep<11>2014 20:17 Aug 14, 2020 Jkt 250001 the call on hold, or over hold music, in which case the call could not be used as a basis for the sale. In addition, a script or sample recording would not permit the Commission to assess whether a particular call was delivered in a ‘‘slow and deliberate manner’’ and at a ‘‘reasonable understandable volume.’’ Without knowing this information, the Commission would be unable to determine conclusively whether any particular verification request was valid. Therefore, the Commission did not adopt this recommendation. With respect to the requirement that sellers accept prescription presentation, the Commission did not receive any comments opposing this proposal, and thus did not consider alternatives. In response to commenter concerns, however, the Commission determined not to permit sellers to select any method of communication, but opted instead to maximize the benefits from the amendment by requiring the seller to present the prescription through the same medium by which the order is placed, or electronic mail, text message, or file upload. For verification requests, the Commission expressly defined alteration as occurring when sellers provide prescribers with the name of a manufacturer or brand other than that specified on a patient’s prescription. However, the Commission provided an exception such that it would not amount to alteration in instances when sellers verify only the contact lens brand or manufacturer that consumers indicate is on their prescriptions after a seller requests that information. As possible alternatives to these changes, the Commission considered whether it could instead rely on the new requirements that sellers (a) provide a method for prescription presentation and (b) meet quality standards for verification calls, but the Commission determined that those requirements alone are inadequate to curb the practice of unlawful substitution to nonprescribed brands through abuse of the verification system. Although the Commission has previously stated that a verification request is not valid and does not commence the eight-businesshour verification period if a seller knows or should know that the verification request includes a different brand and manufacturer than that prescribed, the FTC continues to receive reports about the proliferation of passive verification abuses, and sellers ‘‘gaming the system’’ to substitute a different brand or manufacturer. Furthermore, without the changes to the definition of alteration, sellers may argue that they PO 00000 Frm 00050 Fmt 4701 Sfmt 4700 are technically compliant with the Rule because they submitted verification requests and prescribers had an opportunity to respond to the requests, and may also argue that they did not have knowledge that a consumer did not have a prescription for that manufacturer or brand of lens. The Final Rule amendment will give them a basis of knowledge by requesting that a consumer state the brand or manufacturer of her brand of lens. Additionally, the Commission determined that without the express definition of alteration and the exception thereto, enforcement would not, in and of itself, be adequate to protect consumers, because alteration via abuse of the verification system does not occur with only one bad actor, and because of an increase in companies that appear to alter prescriptions in this way. Seller 1–800 CONTACTS also commented that the amendment should not refer to ‘‘brand’’ as that language does not appear elsewhere in the Rule. It pointed out that the Rule defines a prescription as including a ‘‘material or manufacturer or both’’ and that the Commission’s inclusion of the reference to brand imposes an additional limit on consumer choice that is not required by the Act. 1–800 CONTACTS requested that the exception to the Rule be applicable to ‘‘providing the prescriber with the name of a manufacturer or material other than that specified by the patient’s prescriber . . . .’’ The reference to brand in the definition of alteration and in the exception are the only references to brand in the Rule. However, because many, if not most, prescriptions list the manufacturer’s brand, not the manufacturer or material, and very few consumers know the manufacturer or material of contact lens that they wear (typically referring to their lenses by brand name), the Commission declines to follow 1–800 CONTACTS’ recommendation because many consumers would be unable to respond to a seller’s request. 1–800 CONTACTS expressed concern that the Commission’s amendment might interfere with its ability to improve the user experience. It indicated that it sells hundreds of brands of lenses and offers consumers a variety of methods to identify their brand, including drop-down menus, a search box, and filters that display lenses by brand, modality, and other parameters and that some consumers do not enter their brand information on an order form. In response, the Commission, in the Final Rule, removed the language from its earlier proposal that sellers must obtain the information E:\FR\FM\17AUR2.SGM 17AUR2 Federal Register / Vol. 85, No. 159 / Monday, August 17, 2020 / Rules and Regulations on ‘‘an order form.’’ In comparison, other commenters requested greater specificity or even prohibitions on the acceptable mechanisms for sellers to request and consumers to select their brand. In response, the Commission clarified that, at a minimum, in order for sellers to consider the consumer’s indication of manufacturer or brand as adequate to qualify for the exception, the manufacturer or brand must be: (1) Provided in response to a seller’s request for the manufacturer or brand listed on the consumer’s prescription; and (2) an affirmative statement or selection by the consumer, not a preselected or prefilled entry.631 XIII. Congressional Review Act Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), the Office of Information and Regulatory Affairs designated these rule amendments as not a ‘‘major rule,’’ as defined by 5 U.S.C. 804(2). List of Subjects in 16 CFR Part 315 Advertising, Medical devices, Ophthalmic goods and services, Trade practices. For the reasons discussed in the preamble, the Federal Trade Commission amends title 16 of the Code of Federal Regulations, part 315, as follows: PART 315—CONTACT LENS RULE 1. The authority for part 315 is revised to read as follows: ■ Authority: 15 U.S.C. 7601–7610. 2. Amend § 315.2 by adding in alphabetical order the definitions of ‘‘Provide to the patient a copy’’, ‘‘Reasonably understandable volume’’ and ‘‘Slow and deliberate manner’’ to read as follows: ■ § 315.2 Definitions. * * * * * Provide to the patient a copy means giving a patient a copy of his or her contact lens prescription: (1) On paper; or (2) In a digital format that can be accessed, downloaded, and printed by the patient. For a copy provided in a digital format, the prescriber shall identify to the patient the specific method or methods of electronic delivery to be used, such as text message, electronic mail, or an online patient portal, and obtain the patient’s verifiable affirmative consent to receive a digital copy through the identified method or methods; and maintain records or evidence of a patient’s 631 See Section VI.B., supra. VerDate Sep<11>2014 20:17 Aug 14, 2020 Jkt 250001 affirmative consent for a period of not less than three years. Such records or evidence shall be available for inspection by the Federal Trade Commission, its employees, and its representatives. Reasonably understandable volume means at an audible level that renders the message intelligible to the receiving audience. Slow and deliberate manner means at a rate that renders the message intelligible to the receiving audience. ■ 3. Amend § 315.3 by: ■ a. Revising paragraphs (a)(1) and (2); ■ b. Adding paragraph (a)(3); ■ c. Revising paragraphs (b)(1) through (3); and ■ d. Adding paragraph (c). The additions and revisions read as follows: § 315.3 Availability of contact lens prescriptions to patients. (a) In general. When a prescriber completes a contact lens fitting, the prescriber: (1) Whether or not requested by the patient, shall provide to the patient a copy of the contact lens prescription; (2) Shall, as directed by any person designated to act on behalf of the patient, verify the contact lens prescription by electronic or other means; and (3) Shall, upon request, provide any person designated to act on behalf of the patient with a copy of the patient’s contact lens prescription by electronic or other means within forty (40) business hours of receipt of the request. A prescriber shall note in the patient’s record the name of the requester and the date and time that the prescription was provided to the requester. (b) Limitations. A prescriber may not: (1) Require the purchase of contact lenses from the prescriber or from another person as a condition of providing a copy of a prescription under paragraph (a)(1) or (a)(3) of this section or as a condition of verification of a prescription under paragraph (a)(2) of this section; (2) Require payment in addition to, or as part of, the fee for an eye examination, fitting, and evaluation as a condition of providing a copy of a prescription under paragraph (a)(1) or (a)(3) of this section or as a condition of verification of a prescription under paragraph (a)(2) of this section; or (3) Require the patient to sign a waiver or release as a condition of releasing or verifying a prescription under paragraph (a)(1), (a)(2), or (a)(3) of this section. (c) Confirmation of prescription release. (1)(i) Upon completion of a PO 00000 Frm 00051 Fmt 4701 Sfmt 4700 50717 contact lens fitting, the prescriber shall do one of the following: (A) Request that the patient acknowledge receipt of the contact lens prescription by signing a statement confirming receipt of the contact lens prescription; (B) Request that the patient sign a prescriber-retained copy of a contact lens prescription that contains a statement confirming receipt of the contact lens prescription; (C) Request that the patient sign a prescriber-retained copy of the receipt for the examination that contains a statement confirming receipt of the contact lens prescription; or (D) If a digital copy of the prescription was provided to the patient (via methods including an online portal, electronic mail, or text message) in compliance with paragraph (a)(1) of this section, retain evidence that the prescription was sent, received, or made accessible, downloadable, and printable. (ii) If the prescriber elects to confirm prescription release via paragraphs (c)(1)(i)(A), (B), or (C) of this section, the prescriber may, but is not required to, use the statement, ‘‘My eye care professional provided me with a copy of my contact lens prescription at the completion of my contact lens fitting’’ to satisfy the requirement. (iii) In the event the patient declines to sign a confirmation requested under paragraph (c)(1)(i)(A), (B), or (C) of this section, the prescriber shall note the patient’s refusal on the document and sign it. (2) A prescriber shall maintain the records or evidence required under paragraph (c)(1) of this section for a period of not less than three years. Such records or evidence shall be available for inspection by the Federal Trade Commission, its employees, and its representatives. (3) Paragraphs (c)(1) and (c)(2) of this section shall not apply to prescribers who do not have a direct or indirect financial interest in the sale of contact lenses, including, but not limited to, through an association, affiliation, or colocation with a contact lens seller. ■ 4. Amend § 315.5 by: ■ a. Redesignating paragraphs (d), (e), (f), and (g) as paragraphs (e), (f), (h), and (i), respectively; ■ b. Adding new paragraph (d); ■ c. Revising newly redesignated paragraph (f); ■ d. Adding new paragraph (g); ■ e. Adding new paragraph (h)(2)(iii); ■ f. Revising newly redesignated paragraph (i). The additions and revisions read as follows: E:\FR\FM\17AUR2.SGM 17AUR2 50718 § 315.5 Federal Register / Vol. 85, No. 159 / Monday, August 17, 2020 / Rules and Regulations Prescriber verification. * * * * * (d) Automated telephone verification messages. If a seller verifies prescriptions through calls that use, in whole or in part, an automated message, the seller must: (1) Record the entire call; (2) Commence the call by identifying it as a request for prescription verification made in accordance with the Contact Lens Rule; (3) Deliver the information required by paragraph (b) of this section in a slow and deliberate manner and at a reasonably understandable volume; and (4) Make the information required by paragraph (b) of this section repeatable at the prescriber’s option. * * * * * (f) No alteration of prescription. A seller may not alter a contact lens prescription. In the context of prescription verification, alteration includes, but is not limited to, providing the prescriber with the name of a manufacturer or brand other than that specified by the patient’s prescription, unless such name is provided because the patient entered or orally provided it when asked for the manufacturer or VerDate Sep<11>2014 20:17 Aug 14, 2020 Jkt 250001 brand listed on the patient’s prescription. Notwithstanding the preceding sentences, for private label contact lenses, a seller may substitute for contact lenses specified on a prescription identical contact lenses that the same company manufactures and sells under different labels. (g) Seller requirement to accept prescription presentation: A seller shall provide a prominent method, and a clear and prominent disclosure of that method, for the patient to present the seller with a copy of the patient’s prescription. Such method and the disclosure shall be provided prior to requesting a prescriber’s contact information for verification of the prescription; provided, however, in the case of an order placed by telephone, a seller shall comply by providing a disclosure of the method prior to requesting a prescriber’s contact information for verification of the prescription. The method to present the prescription shall be provided through (i) the same medium by which the order is placed, or (ii) electronic mail, text message, or file upload. (h) * * * (2) * * * PO 00000 Frm 00052 Fmt 4701 Sfmt 9990 (iii) If the communication occurs via telephone and uses an automated message, the complete recording required pursuant to paragraph (d)(1) of this section. * * * * * (i) Recordkeeping requirement— Saturday business hours. A seller that exercises its option to include a prescriber’s regular Saturday business hours in the time period for a request for a copy of the prescription specified in § 315.3(a)(3) or for verification specified in paragraph (c)(3) of this section shall maintain a record of the prescriber’s regular Saturday business hours and the basis for the seller’s actual knowledge thereof. Such records shall be maintained for a period of not less than three years, and these records must be available for inspection by the Federal Trade Commission, its employees, and its representatives. By direction of the Commission. April J. Tabor, Secretary. [FR Doc. 2020–14206 Filed 8–14–20; 8:45 am] BILLING CODE 6750–01–P E:\FR\FM\17AUR2.SGM 17AUR2

Agencies

[Federal Register Volume 85, Number 159 (Monday, August 17, 2020)]
[Rules and Regulations]
[Pages 50668-50718]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-14206]



[[Page 50667]]

Vol. 85

Monday,

No. 159

August 17, 2020

Part III





Federal Trade Commission





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16 CFR Part 315





Contact Lens Rule; Final Rule

Federal Register / Vol. 85, No. 159 / Monday, August 17, 2020 / Rules 
and Regulations

[[Page 50668]]


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FEDERAL TRADE COMMISSION

16 CFR Part 315

RIN 3084-AB36


Contact Lens Rule

AGENCY: Federal Trade Commission (``FTC'' or ``Commission'').

ACTION: Final rule.

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SUMMARY: The FTC is publishing a final rule to implement amendments to 
the Contact Lens Rule. These amendments require that prescribing eye 
care practitioners obtain a confirmation of prescription release from 
patients after releasing a contact lens prescription and maintain each 
such acknowledgment for a period of not less than three years. The 
Commission is permitting prescribers to comply with automatic 
prescription release via electronic delivery in certain circumstances. 
Further, these amendments specify a time period for prescribers to 
respond to requests for prescriptions; clarify and institute additional 
requirements for automated telephone verification messages; more 
precisely delineate what constitutes unlawful alteration of a 
prescription; and require that sellers provide a method for, and notice 
of the method for, patient prescription presentation.

DATES: This rule is effective October 16, 2020.

ADDRESSES: Relevant portions of the record of this proceeding, 
including this document, are available at https://www.ftc.gov.

FOR FURTHER INFORMATION CONTACT: Alysa Bernstein (202-326-3289), 
[email protected], Paul Spelman (202-326-2487), [email protected], or 
Andrew Wone (202-326-2934), [email protected], Bureau of Consumer 
Protection, Federal Trade Commission, 600 Pennsylvania Avenue NW, 
Washington, DC 20580.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background
    A. Overview of the Contact Lens Rule
    B. History of the Rule
    C. Initial Request for Comments in 2015
    D. Notice of Proposed Rulemaking in 2016
    E. Supplemental Notice of Proposed Rulemaking
II. Final Rule Pertaining to Confirmation of Prescription Release
    A. Proposed Modifications in the SNPRM
    B. Basis for SNPRM Confirmation of Prescription Release Proposal
    C. Comments on the Confirmation of Prescription Release Proposal 
and the Basis for Such Proposal
    1. Comments About the Need for the Confirmation of Prescription 
Release and Whether Prescribers Are Complying With the Rule's 
Automatic Prescription Release Requirement
    a. Survey Evidence as Proof of Non-Compliance
    b. Lack of Consumer Complaints as Evidence of Compliance
    c. Number of Verifications as Evidence of Non-Compliance With 
the Automatic Prescription Release Requirement
    2. Comments About the Need To Improve the Commission's Ability 
To Monitor Compliance and Enforce the Rule
    3. Comments About Whether the Structure of the Contact Lens 
Market Creates a Need for Verifiable Enforcement of Automatic 
Prescription Release
    4. Comments About the Text of the Proposed Confirmation of 
Prescription and the Option To Include the Confirmation as Part of a 
Patient's Prescription or Sales Receipt
    5. Comments About Option (D) and Using Electronic Delivery for 
Confirmation of Prescription Release
    a. Use of Patient Portals and Patient Consent
    b. Requirement To Maintain Records of Patient Consent
    6. Comments About Alternatives to the Confirmation of 
Prescription Release
    a. Signage
    b. Educational Programs as an Alternative to Confirmation of 
Prescription Release
    7. Comments About the Burden and Benefits of the Confirmation of 
Prescription Release Proposal
    8. Comments About the Exemption for Prescribers Who Do Not Have 
a Direct or Indirect Financial Interest in the Sale of Contact 
Lenses
    D. Additional Discussion and Commission Determination Regarding 
the Confirmation of Prescription Release Proposal
III. Additional Requirements for Sellers Using Verification Calls 
Containing Automated Messages
    A. The Congressional Record Does Not Support Prohibiting 
Automated Telephone Messages
    B. Comments About, and Adoption of, Requirements Proposed in the 
SNPRM To Improve Quality of Automated Telephone Messages
    C. The Commission's Proposal Requiring Sellers To Record 
Automated Telephone Messages
    D. The Final Rule Does Not Adopt Commenters' Additional 
Recommendations Regarding Automated Telephone Messages
IV. Prescribers' Selection of Communication Mechanism
V. Miscellaneous Passive Verification Issues
    A. Active Verification Is Not Required
    B. Concerns About Patient Manipulation
    C. Eight-Business-Hour Time Frame Is Appropriate
VI. Seller Alteration of Contact Lens Prescriptions and Private 
Label Concerns
    A. The Final Rule Includes a Requirement for Sellers To Accept 
Prescription Presentation
    B. Alteration Includes a Seller Providing a Prescriber With a 
Verification Request for a Non-Prescribed Manufacturer or Brand, but 
Includes an Exception for Verifying a Manufacturer or Brand That a 
Consumer Indicates Is on Her Prescription
    1. The Final Rule Modifications Regarding Alteration Are 
Beneficial and Address Abuses of the Verification System
    2. Comments Related to the Exception to Alteration When a Seller 
Provides the Manufacturer or Brand of Lenses That a Consumer 
Provides in Response to a Seller's Request for That Information
    3. Comments Regarding and Commission Guidance on Acceptable 
Methods for Obtaining the Brand or Manufacturer Listed on Consumers' 
Prescriptions
    4. The Commission Is Not Imposing a Recordkeeping Requirement 
for Sellers Related to the Exception
    C. Private Label Issues
    1. The Commission Adopts a Technical Amendment and Clarifies 
That the Only Permissible Substitution Involves Private Label Lenses
    2. The Commission Is Not Imposing Additional Requirements on 
Prescriptions for Private Label Lenses
VII. ``Directly or by Facsimile'' Language Includes Use of Online 
Patient Portals to Present Prescriptions
VIII. Requests for an Additional Copy of a Prescription
    A. Benefits of an Additional Copy and the Time Period To Respond 
to a Request
    B. Requirement To Maintain Records
IX. Excessive Quantity
X. Expiration of Contact Lens Prescriptions
    A. Length of Contact Lens Prescriptions
    B. Sales Using Expired Contact Lens Prescriptions
XI. Paperwork Reduction Act
    A. Confirmation of Prescription Release and Affirmative Consent 
to Digital Delivery of a Prescription
    1. SNPRM Burden Estimate for the Confirmation of Prescription 
Release
    2. Comments Regarding the SNPRM Estimate for the Confirmation of 
Prescription Release Requirement
    3. Estimated Additional Burden Hours for the Confirmation of 
Prescription Release Requirement
    4. Estimated Total Labor Cost Burden for the Confirmation of 
Prescription Release Modification
    5. Capital and Other Non-Labor Costs for the Confirmation of 
Prescription Release Requirement
    B. Recording of Automated Telephone Messages
    C. Total Burden for the Modifications to the Rule
XII. Regulatory Flexibility Act
    A. Need for and Objectives of the Rule Amendments
    1. Amendments Affecting Prescribers
    2. Amendments Affecting Sellers
    B. Significant Issues Raised by Public Comments in Response to 
the IRFA, Including Any Comments Filed by the Chief Counsel for 
Advocacy of the Small Business Administration, and the Agency's 
Response, Including Any Changes Made in the Final Rule Amendments
    1. Amendments Affecting Prescribers

[[Page 50669]]

    2. Amendments Affecting Sellers
    C. Description and Estimate of the Number of Small Entities to 
Which the Amendments Will Apply or Explanation Why No Estimate Is 
Available
    D. Description of the Projected Reporting, Recordkeeping and 
Other Compliance Requirements of the Amendments, Including an 
Estimate of the Classes of Small Entities That Will Be Subject to 
the Requirement and the Type of Professional Skills Necessary for 
Preparation of the Report or Record
    1. Amendments Affecting Prescribers
    2. Amendments Affecting Sellers
    E. Steps Taken To Minimize the Significant Impact, if Any, of 
the Amendments, Including Why Any Significant Alternatives Were Not 
Adopted
    1. Steps and Alternatives for Amendments Affecting Prescribers
    2. Steps and Alternatives for Amendments Affecting Sellers
XIII. Congressional Review Act

I. Background

A. Overview of the Contact Lens Rule

    In 2003, Congress enacted the Fairness to Contact Lens Consumers 
Act (``FCLCA'' or ``Act''),\1\ and pursuant to the Act, the Commission 
promulgated the Contact Lens Rule on July 2, 2004.\2\ The Rule went 
into effect on August 2, 2004.
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    \1\ 15 U.S.C. 7601-7610 (Pub. L. 108-164).
    \2\ Contact Lens Rule, 16 CFR part 315 (2015).
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    The Contact Lens Rule (``Rule'') promotes competition in retail 
sales of contact lenses by facilitating consumers' ability to 
comparison shop for contact lenses. When an eye care practitioner 
(``prescriber'') \3\ completes a contact lens fitting, the Rule 
requires that the prescriber automatically provide the patient with a 
portable copy of the patient's prescription, whether or not the patient 
requests it.\4\ The Rule also requires that the prescriber verify or 
provide such prescriptions to authorized third parties. At the same 
time, the Rule requires that sellers only sell contact lenses in 
accordance with valid prescriptions written by licensed prescribers 
that were either (a) presented to the seller by the patient or a 
designated agent of the patient or (b) verified by direct communication 
with the prescriber.\5\
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    \3\ Under the Rule, prescriber is defined as an ophthalmologist, 
optometrist, or other person permitted under State law to issue 
prescriptions for contact lenses in compliance with any applicable 
requirements established by the Food and Drug Administration. `Other 
person,' in this context, includes dispensing opticians who are 
permitted under State law to issue prescriptions and who are 
authorized or permitted under State law to perform contact lens 
fitting services. 16 CFR 315.2.
    \4\ The Commission also notes that apart from requiring that the 
contact lens fitting be complete, the FCLCA and Rule do not include 
any other requirements or exceptions that would permit a prescriber 
to withhold a patient's contact lens prescription following a 
fitting. 16 CFR 315.3(a)(1). Therefore, prescribers must 
automatically provide patients with copies of their prescriptions 
following their fitting, regardless of whether patients indicate an 
intention to purchase contact lenses--no matter the quantity (and 
even an annual supply)--from their prescribers.
    \5\ 16 CFR 315.5(a).
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    The Rule further sets out the information that must be included in 
a seller's verification request, and directs that a prescription is 
only verified under the Rule if: (1) The prescriber confirms the 
prescription is accurate; (2) the prescriber informs the seller that 
the prescription is inaccurate and provides an accurate prescription in 
its stead; or (3) the prescriber fails to communicate with the seller 
within eight business hours after receiving a compliant verification 
request.\6\ The Rule states that if the prescriber informs the seller 
within eight business hours of receiving the verification request that 
the prescription is inaccurate, expired, or invalid, the seller shall 
not fill the prescription. The Rule requires that the prescriber 
specify the basis for the inaccuracy or invalidity of the prescription, 
and if the prescription is inaccurate, the prescriber must correct 
it.\7\ Sellers may not alter a prescription, but for private label 
contact lenses, may substitute identical contact lenses that the same 
company manufactures and sells under a different name.\8\
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    \6\ 16 CFR 315.5(b)-(c).
    \7\ 16 CFR 315.5(d).
    \8\ 16 CFR 315.5(e).
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    The Contact Lens Rule sets a minimum expiration date of one year 
after the issue date of a prescription with an exception based on a 
patient's ocular health.\9\ The Rule also incorporates the Act's 
preemption of state and local laws and regulations that establish a 
prescription expiration date of less than one year or that restrict 
prescription release or require active verification.\10\
---------------------------------------------------------------------------

    \9\ 16 CFR 315.6.
    \10\ 16 CFR 315.11(a). The Rule also preempts any other state or 
local laws or regulations that are inconsistent with the Act or the 
relevant section of the Rule, to the extent of the inconsistency. 16 
CFR 315.11(b).
---------------------------------------------------------------------------

B. History of the Rule

    The FTC has more than three decades of regulatory and research 
experience regarding the optical goods industry; this history continues 
to inform the basis and purpose of the Contact Lens Rule and this rule 
review. In addition to the Rule, the Commission enforces the Ophthalmic 
Practice Rules (known as the ``Eyeglass Rule''), initially promulgated 
in 1978.\11\ Prior to the Eyeglass Rule, surveys of optometrists found 
that a majority of prescribers imposed some restriction on the 
availability of the patient's prescription, usually by either refusing 
to release prescriptions or charging an additional fee to do so.\12\ 
Prescribers also used waivers and liability disclaimers to discourage 
comparison shopping, mislead consumers, and frighten them into 
purchasing ophthalmic goods from the prescriber.\13\ The Commission 
determined that these actions reduced consumers' ability to obtain the 
lowest prices and hindered competition in the optical marketplace.\14\ 
To address these problems, the Eyeglass Rule required prescribers--
generally, optometrists and ophthalmologists--to provide each of their 
patients, immediately after completion of an eye examination, a free 
copy of the patient's eyeglass prescription.\15\
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    \11\ Final Trade Regulation Rule, Advertising of Ophthalmic 
Goods and Services, 43 FR 23992 (June 2, 1978) [hereinafter Eyeglass 
I]. The Rule was revised in 1992, with the revisions codified at 16 
CFR part 456. Ophthalmic Practice Rules, 57 FR 18822 (May 1, 1992).
    \12\ 43 FR at 23998. See also FTC, ``Staff Report on Advertising 
of Ophthalmic Goods and Services and Proposed Trade Regulation 
Rule'' 240-48 (1977) [hereinafter 1977 Staff Report] (detailing 
myriad accounts of prescribers refusing to release eyeglass 
prescriptions to their patients), https://www.ftc.gov/system/files/documents/reports/staff-report-advertising-ophthalmic-goods-services-proposed-trade-regulation-rule-16-cfr-part-456/r611003-staff_report_on_advertising_of_ophthalmic_goods_and_services_and_proposed_trade_regulation.pdf.
    \13\ 43 FR at 23998; Am. Optometric Ass'n v. FTC, 626 F.2d 896, 
916 (D.C. Cir. 1980) (noting considerable ``evidence of abuse'' by 
prescribers); see also 1977 Staff Report, supra note 12, at 277.
    \14\ FTC, ``The Strength of Competition in the Sale of Rx 
Contact Lenses: An FTC Study'' 45-46 (2005), https://www.ftc.gov/sites/default/files/documents/reports/strength-competition-sale-rx-contact-lenses-ftc-study/050214contactlensrpt.pdf [hereinafter 2005 
Contact Lens Report].
    \15\ 16 CFR 456.2 (separation of examination and dispensing). 
The FTC also has studied the effects of state-imposed restrictions 
in the optical goods industry. See FTC, ``The Effects of 
Restrictions on Advertising and Commercial Practice in the 
Professions: The Case of Optometry'' (1980), https://www.ftc.gov/sites/default/files/documents/reports/effects-restrictions-advertising-and-commercial-practice-professions-case-optometry/198009optometry.pdf.
---------------------------------------------------------------------------

    The Eyeglass Rule, however, did not encompass contact lens 
prescriptions. While a majority of states enacted their own statutes 
requiring some form of contact lens prescription release,\16\ many 
prescribers continued to withhold prescriptions for contact lenses.\17\ 
This,

[[Page 50670]]

and other prescriber practices (such as requiring liability waivers, 
refusing to verify prescriptions when consumers tried to buy lenses 
from third-party sellers, and encouraging manufacturers not to 
distribute contact lenses to third-party sellers), made it challenging 
for consumers to obtain lenses from anyone other than their 
prescribers.\18\ According to Congress, these obstacles were rooted in 
an ``inherent conflict of interest'' in that ``[u]nlike medical doctors 
who are prohibited from selling the drugs they prescribe, eye doctors 
and optometrists . . . are able to fill the contact lens prescriptions 
they write.'' \19\ Third-party sellers are thus forced to compete for 
the sale of lenses with the individual who is writing the 
prescription.\20\ To address this inherent conflict of interest and 
achieve freedom of choice and the benefits of competition for contact 
lens consumers, Congress passed the Fairness to Contact Lens Consumers 
Act in 2003,\21\ and, in 2004, the Commission issued the Contact Lens 
Rule,\22\ implementing the Act.
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    \16\ By 2003, more than two-thirds of states had laws requiring 
some form of contact lens prescription release. H.R. Rep. No. 108-
318, 108th Cong., 1st Sess. 4 (2003), at 8 (2003).
    \17\ See id. at 4 (noting that ``[t]he practice of optometrists 
withholding the prescription [for contact lenses] has limited the 
consumer's ability to shop for the best price and has impacted 
competition''); Fairness to Contact Lens Consumers Act: Hearing 
Before the Subcomm. on Commerce, Trade, and Consumer Protection of 
the H. Comm. on Energy and Commerce, 108th Cong. 1 (2003) 
[hereinafter FCLCA Subcomm. Hearing] (statement of Ami Gadhia, 
Consumers Union) (noting that multiple surveys of consumers in Texas 
had found considerable numbers were unable to obtain their contact 
lens prescription from their prescribers).
    \18\ H.R. Rep. No. 108-318, at 4; FCLCA Subcomm. Hearing, supra 
note 17 (statements of Howard Beales, Jonathan Coon, Ami Gadhia, 
Robert Hubbard, Maria Martinez, Rep. W. J. Tauzin; Peggy Venable). 
See also In re Disposable Contact Lens Antitrust Litig., No. 94-MDL 
1030-J-20A (M.D. Fla.), in which the Attorneys General of 31 states 
alleged that eye-care professionals engaged in an organized effort 
to prevent or hinder consumers from obtaining their contact lens 
prescriptions. The complaints alleged two conspiracies: (1) That the 
practitioners and their trade associations conspired to prevent the 
release of contact lens prescriptions to consumers, and (2) that 
manufacturers, practitioners, and trade associations, including the 
American Optometric Association, conspired to eliminate sales of 
contact lenses by pharmacies, mail order, and other alternative 
sellers. Id. According to the Attorneys General, the conspiracy 
severely restricted the supply of contact lenses available to 
alternative sellers, which hampered the growth of such sellers, 
decreased the supply of lenses to consumers, and increased the price 
of lenses. Id. The parties reached settlements, the last of which 
the court approved in November 2001. As part of the settlements, 
manufacturers agreed to sell contact lenses to alternative 
distribution channels.
    \19\ H.R. Rep. No. 108-318, at 5. See also Letter from Senators 
Richard Blumenthal and Orrin G. Hatch of the United States Senate 
Regarding the Contact Lens Rule Rulemaking Proceeding and the 
Proposed Rule Set Forth in the Notice of Proposed Rulemaking (Aug. 
11, 2017) (recognizing the ``inherent conflict of interest'' and 
noting that the FCLCA was made necessary by ``the unique nature of 
the contact lens marketplace''), https://www.ftc.gov/system/files/filings/initiatives/677/public_comment_from_senators_blumenthal_and_hatch_re_contact_lens_rulemaking.pdf [hereinafter Blumenthal Letter].
    \20\ H.R. Rep. No. 108-318, at 4; FCLCA Subcomm. Hearing, supra 
note 17 (statements of Rep. W.J. Tauzin) (noting there is a 
``classic conflict of interest that robs the consumers of the 
ability to shop competitively for the best price,'' and stating that 
the FCLCA takes the ``necessary steps to remedy this stranglehold on 
contact lens competition'').
    \21\ 15 U.S.C. 7601-7610. The FCLCA passed with a vote of 406 in 
favor and 12 opposed in the House, and unanimous consent in the 
Senate.
    \22\ Contact Lens Rule, 69 FR 40482 (July 2, 2004) (codified at 
16 CFR pt. 315). Pursuant to its congressional mandate, the FTC also 
issued a study of competition in the contact lens industry in 2005. 
See 2005 Contact Lens Report, supra note 14.
---------------------------------------------------------------------------

    As specified in the Act, the Rule imposes requirements on both 
sellers and prescribers of contact lenses. Because the use of contact 
lenses involves significant health issues \23\ and Congress recognized 
that consumers may be harmed by contact lenses purchased with an 
expired, inaccurate, or otherwise invalid prescription,\24\ the Act 
requires that contact lenses be sold only to patients with valid 
prescriptions, which they receive after contact lens fittings by a 
prescriber. The Act and the Rule only allow sales of contact lenses 
when a patient presents a seller with a copy of the prescription or the 
seller has verified the patient's prescription with the prescriber.\25\ 
Sellers also are prohibited from altering a contact lens 
prescription.\26\
---------------------------------------------------------------------------

    \23\ See, e.g., FTC, ``Possible Barriers to E-Commerce: Contact 
Lenses, A Report from the Staff of the Federal Trade Commission'' 8-
9 (2004), https://www.ftc.gov/sites/default/files/documents/advocacy_documents/possible-anticompetitive-barriers-e-commerce-contact-lenses-report-staff-ftc/040329clreportfinal.pdf.
    \24\ Contact Lens Rule, 69 FR 40482.
    \25\ 16 CFR 315.5(a).
    \26\ 16 CFR 315.5(e).
---------------------------------------------------------------------------

    The Act and the Rule further impose obligations on prescribers. 
First and foremost, prescribers are required to release a copy of the 
prescription to the patient promptly upon completion of the contact 
lens fitting, ``[w]hether or not requested by the patient.'' \27\ 
Prescribers also are prohibited from requiring: (1) The purchase of 
contact lenses as a condition of either prescription release or 
verification, (2) a separate payment for prescription release or 
verification, and (3) that the patient sign a waiver as a condition of 
prescription release or verification.\28\
---------------------------------------------------------------------------

    \27\ 15 U.S.C. 7601(a)(1); 16 CFR 315.3(a)(1).
    \28\ 15 U.S.C. 7601(b)(1)-(3); 16 CFR 315.3(b)(1)-(3).
---------------------------------------------------------------------------

    Additionally, prescribers are required to provide or verify a 
contact lens prescription when ``directed by any person designated to 
act on behalf of the patient.'' \29\ Such verification occurs when the 
seller provides the prescriber with a consumer's prescription 
information and: (1) The prescriber confirms that the prescription is 
accurate, by phone, facsimile, or electronic mail; (2) the prescriber 
informs the seller that the prescription is inaccurate and provides the 
correct prescription; or (3) the prescriber does not communicate with 
the seller within eight business hours of the seller's request for 
verification (``passive verification'').\30\ The eight-business-hour 
passive verification lessens the demands on prescribers in the event a 
seller forwards a query about an accurate and complete prescription 
from a properly identified patient. It also prevents prescribers from 
blocking verification--and impeding consumer access to contact lenses 
that may be lower-priced, or sold by sellers who offer other benefits 
or convenience--simply by refusing to respond to verification requests.
---------------------------------------------------------------------------

    \29\ 15 U.S.C. 7601(a)(2); 16 CFR 315.3(a)(2).
    \30\ 15 U.S.C. 7603(d)(1)-(3); 16 CFR 315.5.
---------------------------------------------------------------------------

    One outcome of passive verification, however, is that, if a 
prescriber does not respond to a verification request containing 
inaccurate information or for an invalid prescription within eight 
business hours, the prescription is deemed verified; thus, passive 
verification allows for the possibility that patients can be sold 
lenses for which they do not have a valid prescription. Congress, when 
considering the FCLCA, was aware that a passive-verification regime 
could, in some instances, allow sellers to sell and ship contact lenses 
based on an invalid or inaccurate prescription, and that this could 
potentially lead to health risks.\31\ Congress opted for a passive-
verification regime despite this concern in order ``to ensure that 
consumers are not caught in the competitive tug-of-war between doctors 
and third party sellers for the sale of contact lenses.'' \32\ It was 
also envisioned that prescribers would remain diligent in ensuring that 
patients did not receive lenses for which they had not been prescribed, 
since it is in both prescribers' self-interest and the health and 
safety interests of their patients to prevent this from occurring.\33\ 
In this manner, the passive-verification system was perceived, to a 
certain extent, to be self-enforcing, as prescribers would have both a 
financial interest and an ethical duty to police invalid, incorrect, or 
expired prescriptions.\34\
---------------------------------------------------------------------------

    \31\ See, e.g., FCLCA Subcomm. Hearing, supra note 17 
(statements of Howard Beales, Federal Trade Commission); id. 
(statements of J. Pat Cummings, American Optometric Association) 
(``And the problem with passive verification is that people will get 
contact lenses without a prescription.'').
    \32\ H.R. Rep. No. 108-318, at 5.
    \33\ Contact Lens Rule, 69 FR at 40498.
    \34\ FCLCA Subcomm. Hearing, supra note 17 (statements of Howard 
Beales, Federal Trade Commission) (stating that passive verification 
is in many respects self-enforcing). See also id. (statements of 
Jonathan Coon, 1-800 CONTACTS) (explaining to the Committee that 
from their experience with an existing passive verification-system 
in California, doctors have motivation to block invalid-prescription 
sales. ``So they tell us if there is any problem with the 
prescription, if it's expired, it's invalid, whatever the problem is 
with the prescription. If they can tell us, you can believe they 
tell us absolutely every time.'').

---------------------------------------------------------------------------

[[Page 50671]]

C. Initial Request for Comments in 2015

    As part of its periodic review of its rules and guides, on 
September 3, 2015, the Commission solicited comments on the Contact 
Lens Rule, seeking input on: The economic impact of, and continuing 
need for, the Rule; the benefits of the Rule to consumers purchasing 
contact lenses; the burdens the Rule places on entities subject to its 
requirements; the impact the Rule has had on the flow of information to 
consumers; the degree of industry compliance with the Rule; the need 
for any modifications to increase its benefits or reduce its burdens or 
to account for changes in relevant technology; and any overlap or 
conflict with the Rule and other federal, state, or local laws or 
regulations.\35\ The comment period for this initial request closed on 
October 26, 2015. The Commission received approximately 660 comments 
from individuals and entities representing a wide range of viewpoints, 
including prescribing eye-care practitioners (ophthalmologists and 
optometrists), opticians and other eye-wear industry members, sellers 
of contact lenses (both online and brick-and-mortar), contact lens 
manufacturers, and consumers.\36\
---------------------------------------------------------------------------

    \35\ Contact Lens Rule Request for Comment (``RFC''), 80 FR 
53272 (Sept. 3, 2015).
    \36\ Comment figures are approximations because identical 
comments are sometimes submitted more than once. RFC comments are 
available at https://www.ftc.gov/policy/public-comments/2015/09/initiative-621.
---------------------------------------------------------------------------

D. Notice of Proposed Rulemaking in 2016

    After a review of comments, surveys, other submitted information, 
and its own enforcement experience, the Commission determined that the 
overall weight of the evidence demonstrated a need to improve 
compliance with the Rule's automatic prescription-release requirement, 
as well as a need to create a mechanism for monitoring and enforcing 
the Rule.\37\ To achieve this, the Commission issued a Notice of 
Proposed Rulemaking (``NPRM'') on December 7, 2016 that proposed to add 
a signed-acknowledgment requirement.\38\ The signed-acknowledgment 
requirement was to be triggered once the prescriber presented the 
prescription to the patient, and the acknowledgment form could be in 
either paper or electronic format. As proposed, the acknowledgment form 
was to be entitled ``Patient Receipt of Contact Lens Prescription'' 
(``Signed Acknowledgment''), and state, ``My eye care professional 
provided me with a copy of my contact lens prescription at the 
completion of my contact lens fitting. I understand that I am free to 
purchase contact lenses from the seller of my choice.'' Prescribers 
would be required to maintain copies of the acknowledgment forms in 
paper or electronically for not less than three years.
---------------------------------------------------------------------------

    \37\ Notice of Proposed Rulemaking, 81 FR 88526 (Dec. 7, 2016) 
[hereinafter NPRM].
    \38\ Id. The NPRM also proposed a technical amendment, to remove 
the words ``private label'' from Sec.  315.5(e) to conform the 
language of the Rule to that of the FCLCA.
---------------------------------------------------------------------------

    The NPRM sought comment on this proposal as well as the following 
issues: The provision of additional copies of prescriptions, the amount 
of time for a prescriber to respond to such a request, the use of 
patient portals to release prescriptions, and potential modifications 
to address concerns about automated telephone verification calls. The 
sixty-day comment period for the Commission's NPRM closed on January 
30, 2017.
    In response to its NPRM, the Commission received over 4,000 
additional comments, many from prescribers concerned about the impact 
of the proposed signed-acknowledgment requirement.\39\ After 
considering these and other comments, the Commission determined that 
certain issues deserved additional discussion and examination. To 
obtain additional input and more fully consider commenter concerns, the 
Commission solicited additional comments \40\ and held a public 
workshop on the Contact Lens Rule and the Evolving Contact Lens 
Marketplace on March 7, 2018. The workshop included six panels, 
covering issues relating to the overall contact lens marketplace, 
health and safety, competition, purchasing and verification, the 
proposed Signed Acknowledgment and consumer choice, and the future of 
contact lens prescribing and selling.\41\ In response to the 
Commission's request and workshop, the Commission received 
approximately 3,400 additional comments from a wide range of 
commenters, including numerous consumers and prescribers, as well as 
industry associations, state attorneys general, contact lens 
manufacturers, and contact lens sellers.\42\
---------------------------------------------------------------------------

    \39\ NPRM comments available at https://www.ftc.gov/policy/public-comments/2016/10/initiative-677.
    \40\ Public Workshop Examining Contact Lens Marketplace and 
Analyzing Proposed Changes to the Contact Lens Rule, 82 FR 57889 
(Dec. 8, 2017).
    \41\ Workshop transcripts available at https://www.ftc.gov/news-events/events-calendar/2018/03/contact-lens-rule-evolving-contact-lens-marketplace.
    \42\ Workshop comments available at https://www.ftc.gov/policy/public-comments/2018/01/initiative-733.
---------------------------------------------------------------------------

E. Supplemental Notice of Proposed Rulemaking

    After reviewing the comments submitted in response to the public 
workshop and Notice of Proposed Rulemaking, the Commission issued a 
Supplemental Notice of Proposed Rulemaking (``SNPRM'') on May 28, 2019 
that modified its previous proposal for a Signed Acknowledgment by 
instituting a more flexible Confirmation of Prescription Release 
provision.\43\ In addition, the SNPRM put forth new proposals to modify 
the Rule by: (a) Adding a definition of the term ``provide to the 
patient a copy,'' to allow the prescriber to provide the patient with a 
digital copy of the patient's prescription in lieu of a paper copy; (b) 
providing forty business hours as the time period for which a 
prescriber must provide a prescription upon request to a person 
designated to act on behalf of the patient; (c) creating new message 
delivery and recordkeeping requirements for sellers using automated 
telephone verification messages; (d) amending and clarifying the 
prohibition on seller alteration of prescriptions; and (e) requiring 
that sellers provide a method that would allow patients to present 
their prescriptions to the seller.
---------------------------------------------------------------------------

    \43\ Supplemental Notice of Proposed Rulemaking, 84 FR 24664 
(May 28, 2019) [hereinafter SNPRM].
---------------------------------------------------------------------------

    The Commission requested comment on its SNPRM proposal; the sixty-
day comment period closed on July 29, 2019. In response to its SNPRM, 
the Commission received approximately 200 unique comments (and 
approximately 900 comments total) from a variety of stakeholders, 
including prescribers and prescriber-trade organizations, contact lens 
manufacturers, contact lens sellers, legislators, state attorneys 
general, economic think tanks and academics, consumer-interest 
organizations, and individual consumers themselves.\44\ The majority of 
commenters opined on the Confirmation of Prescription Release proposal, 
and many also commented on the Commission's new proposals regarding 
prescription verification and alteration. This Statement of Basis and 
Purpose for the Final Rule summarizes

[[Page 50672]]

the relevant comments received in response to the proposals set forth 
in the NPRM and SNPRM and explains the Commission's analyses and 
decisions to amend or not amend the Rule.
---------------------------------------------------------------------------

    \44\ SNPRM comments available at https://www.regulations.gov/docket?D=FTC-2019-0041.
---------------------------------------------------------------------------

II. Final Rule Pertaining to Confirmation of Prescription Release

    The following sections discuss the Confirmation of Prescription 
Release proposal in the SNPRM, the comments to the SNPRM in support of 
and opposition to the Confirmation of Prescription Release proposal, 
the Commission's analysis and conclusions, and the amendments to the 
Final Rule instituting a Confirmation of Prescription Release. Because 
many of the comments focused on the Commission's basis for its SNPRM 
proposal, and whether that basis is supported by evidence in the 
record, the Commission also reiterates the basis set forth in the SNPRM 
and discusses related comments and subsequent determinations in this 
Statement of Basis and Purpose for the final amended Contact Lens Rule.
    The Commission's authority to modify the Rule and implement a 
Confirmation of Prescription Release requirement derives from the 
FCLCA, which directed the FTC to prescribe implementing rules, and 
authorized the Commission to investigate and enforce the Act in the 
same manner, by the same means, and with the same jurisdictional powers 
and duties as a trade regulation rule under the Federal Trade 
Commission Act.\45\ Congress clearly intended that prescriptions be 
provided to all consumers at the completion of the contact lens fitting 
process.\46\ Survey evidence, the record of these proceedings, and the 
Commission's own experience with the Rule indicate that is not 
occurring at anywhere near the rate Congress intended. Consequently, 
the Commission believes that imposing a Confirmation of Prescription 
Receipt requirement is critical to effectuate congressional intent to 
the fullest extent.\47\
---------------------------------------------------------------------------

    \45\ 15 U.S.C. 7601-7610 (Pub. L. 108-164).
    \46\ 15 U.S.C. 7601; see also H.R. Rep. No. 108-318, at 4 (2003) 
(``The practice of optometrists withholding the prescription has 
limited the consumer's ability to shop for the best price and has 
[adversely] impacted competition.'').
    \47\ See H.R. Rep. No. 108-318, at 6 (2003) (``The goal of this 
legislation is to allow consumer access to their contact lens 
prescriptions. . . .'').
---------------------------------------------------------------------------

    In a comment to the NPRM, the American Optometric Association 
(``AOA'') contended that the Commission does not have the authority to 
add requirements to the Rule that are not found in the text of the 
FCLCA.\48\ According to the AOA, because the FCLCA is a statute that 
``carefully enumerates specific substantive requirements but not 
others''--as opposed to a general grant of authority--the agency 
charged with administering the FCLCA ``should not add additional 
requirements that Congress did not enact.'' \49\
---------------------------------------------------------------------------

    \48\ American Optometric Association (NPRM Comment #3830).
    \49\ Id.
---------------------------------------------------------------------------

    The Commission does not agree with this interpretation. As noted 
above, the FCLCA contains an express delegation of authority to the FTC 
to craft rules to carry out the Act.\50\ Pursuant to this delegation, 
the FTC has broad rulemaking authority to implement requirements for 
the purpose of preventing unfair or deceptive acts or practices in or 
affecting commerce, including failure to provide patients with copies 
of their prescriptions.\51\ The proposed modification requiring that 
patients sign a Confirmation of Prescription Release is consistent with 
the statute and falls well within the Commission's statutory 
jurisdiction under the FCLCA.\52\
---------------------------------------------------------------------------

    \50\ 15 U.S.C. 7607.
    \51\ See id. (directing the FTC to ``prescribe rules pursuant to 
section 57a of this title to carry out [the FCLCA]''); 15 U.S.C. 
57a(a)(1)(B) (authorizing the FTC to prescribe ``rules which define 
with specificity acts or practices which are unfair or deceptive 
acts or practices in or affecting commerce,'' including rules that 
contain ``requirements prescribed for the purpose of preventing such 
acts or practices''); 15 U.S.C. 7601(a) (mandating that when a 
prescriber completes a contact lens fitting, the prescriber 
``whether or not requested by the patient, shall provide to the 
patient a copy of the contact lens prescription'').
    \52\ 15 U.S.C. 7601(a), 7607. AOA's stance that a statute's 
enumeration of some requirements but not others necessarily 
signifies that Congress deliberately excluded the non-included 
requirements is also incorrect in the rulemaking context. It is well 
established that the canon of statutory interpretation expressio 
unius est exclusion alterius (``the expression of one is the 
exclusion of others'') does not have force in the administrative 
setting, where Congress is presumed to have left to reasonable 
agency discretion questions that it has not directly resolved. See 
Adirondack Med. Ctr. v. Sebelius, 740 F.3d 692, 697 (D.C. Cir. 
2014); St. Marks Place Hous. Co. v. U.S. Dep't of Hous. & Urban 
Dev., 610 F.3d 75 (D.C. Cir. 2010); AFL-CIO v. Chao, 409 F. 3d 377 
(D.C. Cir. 2005); Mobile Comm'cns Corp. of Am. v. FCC, 77 F.3d 1399, 
1404-05 (D.C. Cir. 1996); see also Farrell v. Pompeo, No. 17-490, 
2019 U.S. Dist. LEXIS 205831, *25-27 (D.C. Cir. Nov. 27, 2019).
---------------------------------------------------------------------------

A. Proposed Modifications in the SNPRM

    The SNPRM proposed to amend the NPRM's signed-acknowledgment 
proposal by replacing that requirement with a shorter and more flexible 
Confirmation of Prescription Release provision. Rather than requiring, 
as proposed in the NPRM, that prescribers request that each contact 
lens patient sign a form with mandatory language acknowledging receipt 
of the prescription and an understanding of the right to purchase 
lenses elsewhere,\53\ in the SNPRM the Commission proposed requiring 
prescribers instead to do one of the following:
---------------------------------------------------------------------------

    \53\ NPRM, 81 FR at 88559 (The form would have stated: ``My eye 
care professional provided me with a copy of my contact lens 
prescription at the completion of my contact lens fitting. I 
understand I am free to purchase contact lenses from the seller of 
my choice.'').
---------------------------------------------------------------------------

    (A) Request that the patient acknowledge receipt of the contact 
lens prescription by signing a separate statement confirming receipt of 
the contact lens prescription;
    (B) Request that the patient sign a prescriber-retained copy of a 
contact lens prescription that contains a statement confirming receipt 
of the contact lens prescription;
    (C) Request that the patient sign a prescriber-retained copy of the 
sales receipt for the examination that contains a statement confirming 
receipt of the contact lens prescription; or
    (D) If a digital copy of the prescription was provided to the 
patient (via methods including an online portal, electronic mail, or 
text message), retain evidence that such prescription was sent, 
received, or made accessible, downloadable, and printable.\54\
---------------------------------------------------------------------------

    \54\ SNPRM, 84 FR at 24667.
---------------------------------------------------------------------------

    The Commission's proposal provided sample language for confirmation 
options (A), (B), and (C),\55\ but also allowed prescribers to craft 
their own wording of the signed confirmation for these options if they 
so desired. Unlike the NPRM's signed-acknowledgment proposal, which 
applied to all prescribers, the SNPRM's Confirmation of Prescription 
Release proposal only applied to prescribers with a financial interest 
in the sale of contact lenses.\56\
---------------------------------------------------------------------------

    \55\ The Commission said it had no wish to burden prescribers 
with the task of formulating adequate confirmation language if they 
would prefer to use a sentence from the language the Commission 
previously proposed: ``My eye care professional provided me with a 
copy of my contact lens prescription at the completion of my contact 
lens fitting.'' The Commission said use of such language would 
satisfy the proposed requirement. SNPRM, 84 FR at 24683.
    \56\ Id.
---------------------------------------------------------------------------

B. Basis for SNPRM Confirmation of Prescription Release Proposal

    The Commission explained in the SNPRM that it based its 
Confirmation of Prescription Release proposal on a variety of evidence, 
including: Multiple consumer surveys consistently showing prescriber 
non-compliance with, and lack of consumer awareness of, the Rule's 
prescription-release requirement; numerous accounts of prescribers' 
failure to release prescriptions; the

[[Page 50673]]

persistently high number of verifications, many of which would be 
unnecessary were consumers in possession of their prescriptions; the 
regulatory structure of the contact lens market, which requires a 
consumer to obtain lenses pursuant to a prescription while permitting 
prescribers to sell what they prescribe; and the lack of credible 
empirical evidence rebutting or contradicting the evidence that 
prescribers are not automatically releasing prescriptions, and that 
consumers are not fully aware of their rights.\57\ The Commission also 
noted that the potential benefit of increasing the number of patients 
in possession of their prescriptions is substantial for consumers, 
sellers, and prescribers: Namely, increased flexibility and choice for 
consumers; a reduced verification burden for prescribers and sellers; 
and a reduced likelihood of errors associated with incorrect, invalid, 
and expired prescriptions and, consequently, improved patient 
safety.\58\ The Commission further explained that it faces serious 
challenges enforcing the Rule and monitoring compliance because it 
often comes down to the word of the patient against the word of the 
prescriber, which might require the Commission to issue administrative 
subpoenas and conduct investigational hearings--which could be 
resource-intensive for the Commission and costly, time-consuming, and 
disruptive for prescribers--in order to investigate each potential 
violation.\59\ The Commission thus concluded that some form of retained 
documentation is necessary to improve its ability to enforce and 
monitor prescriber compliance with the prescription-release 
requirements.\60\
---------------------------------------------------------------------------

    \57\ Id. at 24680-81.
    \58\ Id. at 24681.
    \59\ Id.
    \60\ Id.
---------------------------------------------------------------------------

    The Commission also determined that signage--an alternative 
suggested by NPRM commenters--was not an appropriate or effective means 
of ensuring that patients receive their prescriptions as required by 
law.\61\ Lastly, the Commission determined that despite commenter 
concerns, the burden to obtain signatures and retain records would be 
relatively minimal and outweighed by the benefits.\62\ The Commission, 
however, was receptive to an NPRM commenter recommendation to modify 
the signed-acknowledgment proposal in order to further reduce the 
burden and allow for greater flexibility,\63\ and thus the SNPRM's 
Confirmation of Prescription Release proposal included three new 
options for prescribers to obtain or establish proof of prescription 
release and exempted prescribers who lacked a financial interest in the 
sale of contact lenses.\64\ According to the Commission, the 
Confirmation of Prescription Release proposal retained most of the 
benefits of the NPRM's signed-acknowledgment proposal, but would be 
less disruptive and burdensome for prescribers.\65\
---------------------------------------------------------------------------

    \61\ Id.
    \62\ Id. at 24681-82.
    \63\ The recommendation was submitted by the National 
Association of Optometrists and Opticians in its comments to the 
Contact Lens Workshop and the NPRM, see id. at 24680 (citing 
National Association of Optometrists and Opticians (WS Comment 
#3208)).
    \64\ SNPRM, 84 FR at 24683.
    \65\ Id.
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C. Comments on the Confirmation of Prescription Release Proposal and 
the Basis for Such Proposal

    Commenter response to the Commission's proposal in the SNPRM was 
varied. Some commenters applauded the proposed amendments as 
improvements to the prior signed-acknowledgment proposal, and as a 
balanced response to competing interests of consumers, sellers, and 
prescribers.\66\ Some, for instance, praised the confirmation proposal 
as an attempt to increase consumer access to prescriptions while making 
it easier and more efficient for prescribers to adhere to the patient-
acknowledgment requirement by allowing flexible methods for obtaining 
the patient's signature.\67\ Other commenters, however, asserted that 
the proposal watered down prescriber obligations and would thus be less 
effective than the NPRM's signed-acknowledgment proposal in ensuring 
that consumers receive their prescriptions and are aware of their 
rights.\68\ And several commenters, primarily contact lens prescribers, 
stated that despite the increased flexibility, the Confirmation of 
Prescription Release proposal still created too much of a burden for 
prescribers, and they criticized the Commission's approach and the 
evidence relied upon.\69\
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    \66\ R Street Institute (SNPRM Comment #15) (``The Commission's 
proposal is both reasonable and not overly burdensome.''); Grimm 
(SNPRM Comment #36) (``There is no doubt that the modified Contact 
Lens Rule should be embraced by prescribers, sellers, and consumers 
as an improvement to consumer products trade rules.''); Americans 
for Tax Reform (SNPRM Comment #72) (``These changes strike the 
correct balance between promoting the free market and protecting 
important consumer rights.''); Lens.com (SNPRM Comment #85) (``We 
believe you have struck the correct balance . . . .''); Coalition 
for Contact Lens Consumer Choice (SNPRM Comment #89) (``What the FTC 
is proposing is a common sense, minimally-burdensome rule that 
optometrists, ophthalmologists, and consumers alike can and should 
support.''); Taxpayers Protection Alliance (SNPRM Comment #118) 
(``Although we are often critical of government overreach and work 
hard to make government smaller, we believe that the FTC's proposed 
Contact Lens Rule is a government rule that works for taxpayers and 
consumers and creates an open transparent contact lens market in the 
US where taxpayers have real choice and there is real competition in 
the marketplace.''); Attorneys General of 27 States (SNPRM Comment 
#139) (``We believe the proposed modifications in the SNPRM are 
reasonable modifications that balance the interests of consumers, 
eye care professionals, and the eye care industry.'').
    \67\ Anonymous (SNPRM Comment #63); Rawson (SNPRM Comment #68) 
(``This proposed rule allows prescribers the ability to model the 
rule to best fit their practice, but still give the consumers the 
protection and the knowledge they need.'').
    \68\ Consumer Reports (SNPRM Comment #133); 1-800 CONTACTS 
(SNPRM Comment #135).
    \69\ American Optometric Association (SNPRM Comment #96); Reeder 
(SNPRM Comment #55) (even signature on prescription or patient 
receipt is burdensome); Kegler (SNPRM Comment #99) (proposal will 
still place financial and administrative burdens on prescribers).
---------------------------------------------------------------------------

1. Comments About the Need for the Confirmation of Prescription Release 
and Whether Prescribers Are Complying With the Rule's Automatic 
Prescription Release Requirement
a. Survey Evidence as Proof of Non-Compliance
    Many of the SNPRM comments focused on the need for a Signed 
Acknowledgment or Confirmation of Prescription Release, and on whether 
evidence in the record supports the Commission's determination that 
prescribers are not complying with the Rule's prescription-release 
requirement. Several commenters, such as 1-800 CONTACTS, Consumer 
Action, and the Attorneys General of Twenty-Seven States, contended (as 
they did in comments responding to either the NPRM, the Contact Lens 
Workshop, or both) \70\ that prescriber noncompliance remains a 
problem, and that millions of Americans are not receiving their 
prescriptions after a contact lens fitting.\71\ The Attorneys General 
of Twenty-Seven States, for instance, commented that consumers in their 
states continue to report that prescribers are failing to automatically 
provide patient prescriptions in writing.\72\ Likewise, the online 
seller 1-800 CONTACTS submitted a new survey of consumers, conducted 
for it by the

[[Page 50674]]

polling firm Dynata (formerly known as Survey Sampling International), 
showing that prescriber compliance has not markedly improved, despite 
the attention focused on automatic-prescription-release obligations 
since the FTC initiated its rule review in 2015.\73\ According to the 
new survey, nearly 49% of contact lens patients report that their 
prescribers did not automatically give them their prescription after 
their eye examination.\74\ Of those who did not receive their 
prescription automatically, a little more than half received it after 
requesting it, while 43% never received their prescription.\75\ 
Extrapolating this data to the general population of 45 million U.S. 
contact lens users \76\ would mean there are approximately 22 million 
annual violations of the Contact Lens Rule, and that each year more 
than 9.4 million contact lens users do not receive their 
prescriptions.\77\ The 2019 consumer survey data is consistent with 
several prior surveys of contact lens users conducted in 2014, 2015, 
2016, and 2017 on behalf of 1-800 CONTACTS and the consumer rights 
organization Consumer Action,\78\ as well as a survey of eyeglass 
wearers (who, per the FTC's Eyeglass Rule, are also to automatically 
receive their prescriptions following a refractive eye exam) conducted 
on behalf of Warby Parker in 2015.\79\
---------------------------------------------------------------------------

    \70\ See 1-800 CONTACTS (NPRM Comment #3898); 1-800 CONTACTS (WS 
Comment #3207); Consumer Action (NPRM Comment #3721); Comments of 
the Attorneys General of 20 States (NPRM Comment #3804).
    \71\ 1-800 CONTACTS (SNPRM Comment #135); Attorneys General of 
27 States (SNPRM Comment #139).
    \72\ Attorneys General of 27 States (SNPRM Comment #139).
    \73\ 1-800 CONTACTS (SNPRM Comment #135).
    \74\ 1-800 CONTACTS (SNPRM Comment #135, Ex. B). The poll was of 
1011 contact lens users between the ages of 18-49, and the relevant 
questions asked were ``At your last eye exam, did the eye care 
provider provide you with a copy of your contact lens 
prescription?'' and ``In order to obtain a copy of your 
prescription, did you have to ask your eye care provider for it?'' 
Approximately 41% said they received it automatically, 49% said they 
did not, and 10% did not recall or were unsure.
    \75\ Id.
    \76\ Centers for Disease Control, Healthy Contact Lens Wear and 
Care, Fast Facts, https://www.cdc.gov/contactlenses/fast-facts.html.
    \77\ This is based on the estimate--long used to calculate the 
financial burden of the Rule for Paperwork Reduction Act purposes--
that consumers obtain one contact lens prescription per year. See, 
e.g., SNPRM, 84 FR at 24692; Paperwork Reduction Act Proposed 
Collection; Comment Request, 81 FR at 31940; Paperwork Reduction Act 
Proposed Collection; Comment Request, 78 FR at 9392.
    \78\ SNPRM, 84 FR at 24671-72.
    \79\ NPRM, 81 FR at 88531.
---------------------------------------------------------------------------

    Some commenters also pointed to previously-submitted evidence 
indicating that many U.S. contact lens users are still unaware of their 
right to automatically receive their prescriptions and take them 
elsewhere for filling.\80\ While commenters to the SNPRM did not submit 
updated polling data on consumer awareness, several cited previously-
submitted data indicating that between 46-60% of consumers are unaware 
that under federal law a prescriber is required to provide the patient 
with a copy of their prescription after they complete their contact 
lens exam.\81\
---------------------------------------------------------------------------

    \80\ Coalition for Contact Lens Consumer Choice (SNPRM Comment 
#89); Consumer Action (SNPRM Comment #101); 1-800 CONTACTS (SNPRM 
Comment #135).
    \81\ Consumer Action (SNPRM Comment #101) (``Our survey showed a 
fundamental lack of understanding by consumers about their automatic 
right to receive a copy of their prescription''); 1-800 CONTACTS 
(SNPRM Comment #135); see SNPRM 84 FR at 24672 (discussing polls of 
consumer knowledge of their rights).
---------------------------------------------------------------------------

    Another commenter, the National Hispanic Medical Association 
(``NHMA''), noted that polls show that Hispanic patients are 
disproportionately impacted by prescribers' failure to release 
prescriptions, and are less likely to understand their rights under the 
FCLCA.\82\ According to the NHMA, ``Our community continually has been 
victimized and denied their prescriptions by prescribers and doctors at 
a higher rate than most other Americans. We strongly believe that more 
must be done to ensure patients are informed of their rights and given 
copies of their prescriptions.'' \83\
---------------------------------------------------------------------------

    \82\ National Hispanic Medical Association (SNPRM Comment #146).
    \83\ Id.
---------------------------------------------------------------------------

    A number of SNPRM commenters, however, were critical of the polling 
data provided to, and relied upon by, the Commission. The American 
Academy of Ophthalmology (``AAO'') asserted that data showing 
prescriber non-compliance consisted of ``industry-sponsored surveys'' 
and was therefore unreliable.\84\ AAO added that it is ``unaware of 
issues'' with prescribers failing to release prescriptions, and stated 
its members ``know that ophthalmology has a strong record of 
compliance.'' \85\ Likewise, the American Society of Cataract and 
Refractive Surgery (``ASCRS'') asserted that there is no independent 
third-party evidence suggesting physicians are not providing 
prescriptions to patients, and that the Commission is basing compliance 
on ``survey polls sponsored by stakeholders with financial interest in 
the sale of contact lenses.'' \86\ According to the ASCRS, before 
amending the Rule, the Commission should obtain data from a 
disinterested organization.\87\
---------------------------------------------------------------------------

    \84\ American Academy of Ophthalmology (SNPRM Comment #136).
    \85\ Id.
    \86\ American Society of Cataract and Refractive Surgery (SNPRM 
Comment #127).
    \87\ Id.
---------------------------------------------------------------------------

    The AOA was highly critical of polling data supplied by 1-800 
CONTACTS, and stated that since the online seller, in its advertising, 
encouraged consumers to ``skip the trip to the optometrist'' and 
instead renew prescriptions online (via telemedicine), the online 
seller has a demonstrated bias against optometrists that taints the 
material it submits.\88\ The AOA further stated that some consumer 
survey findings may be misleading because it is ``very typical'' for 
consumers to request their prescriptions before their contact lens 
fitting is complete, and thus before prescribers are obligated--under 
the Rule and the FCLCA--to release them to consumers.\89\ Therefore, 
some consumers might indicate on a survey that they were required to 
ask for their prescriptions when, in fact, they asked before they were 
entitled to receive them. As support for this contention, AOA stated 
that it surveyed some of its members and found that 91.7% ``indicated 
that there are times when a patient will ask for his/her prescription 
prior to the finalization of the contact lens fitting.'' \90\
---------------------------------------------------------------------------

    \88\ American Optometric Association (SNPRM Comment #96).
    \89\ Id.
    \90\ Id. The AOA reported this result in its comment, and it 
stated that its survey was of 629 prescribers, but did not provide 
the FTC with the underlying survey data, information about the 
manner in which the survey was conducted, how the 629 prescribers 
were selected, or the specific questions that were asked.
---------------------------------------------------------------------------

    The Commission recognizes that some consumers may think they had to 
ask for their prescriptions when, in fact, they would have received 
them when their fittings were complete. However, the AOA did not 
suggest, nor provide any data or information, as to how often this may 
occur, and thus how much it might skew the results of consumer surveys. 
As a result, the Commission is unable to estimate what portion of the 
49% who stated they did not automatically receive their prescription--
in the most recent survey--gave that response because they 
misunderstood when they were entitled to receive their 
prescription.\91\
---------------------------------------------------------------------------

    \91\ The Commission also notes that eyeglass patients are 
entitled to their prescriptions immediately following their exam 
(since they do not have to wait for a fitting), and thus would 
rarely ask for their prescriptions before they are entitled to them, 
and yet two 2015 surveys of eyeglass wearers--one on behalf of Warby 
Parker, the other for 1-800 CONTACTS--found that 47% and 66%, 
respectively, of eyeglass patients who visited an optometrist 
reported that they were not automatically provided a prescription at 
the end of their exam. NPRM, 81 FR at 88531 (citing Warby Parker 
(Comment #813 on the Ophthalmic Practice Rule), available at https://www.ftc.gov/policy/public-comments/initiative-624); 1-800 CONTACTS 
(RFC Comment #568, Ex. B). This would seem to indicate that most 
consumer reports that they did not receive their prescriptions are 
not based on a misunderstanding of when they are supposed to receive 
them.

---------------------------------------------------------------------------

[[Page 50675]]

    Moreover, even if the Commission were to disregard evidence of 
consumers who obtained their prescriptions only after asking for them, 
five consumer surveys from 2015 to 2019 (six if the Warby Parker 
eyeglass wearers' survey is included) indicate that between 21%-36% of 
consumers--approximately 9.5 to 16.2 million contact lens users each 
year--did not receive their prescriptions at all after getting fitted 
for their lenses.\92\ This level of non-compliance on its own supports 
the Commission's recommendation.
---------------------------------------------------------------------------

    \92\ This approximation is based on the current estimate that 
there are 45 million contact lens users in the United States. 
Centers for Disease Control, Healthy Contact Lens Wear and Care, 
Fast Facts, https://www.cdc.gov/contactlenses/fast-facts.html. The 
results from the individual surveys are as follows: (1) June 2019 
survey by Dynata on behalf of 1-800 CONTACTS of 1011 contact lens 
users found that 21% said they never received their prescriptions 
(1-800 CONTACTS (SNPRM Comment #135)); (2) January 2017 survey by 
Caravan ORC International on behalf of Consumer Action of 2018 
adults found that 31% of contact lens users said that at their last 
eye exam, their doctor did not provide them with a paper copy of 
their prescription (Consumer Action (NPRM Comment #3721)); (3) 
December 2016 survey of 1000 contact lens users by Survey Sampling 
International (``SSI'') on behalf of 1-800 CONTACTS found that 24% 
of consumer respondents said they did not receive their prescription 
(1-800 CONTACTS (NPRM Comment #3898)); (4) October 2015 SSI survey 
of 500 contact lens users and 303 eyeglass users on behalf of 1-800 
CONTACTS found that 36% of contact lens users and 39% of eyeglass 
wearers said they did not receive their prescription (1-800 CONTACTS 
(RFC Comment #568, Ex. B)); (5) May 2015 SSI survey of 2000 contact 
lens wearers found that 34% said they did not receive their 
prescription (1-800 CONTACTS (RFC Comment #568, Ex. C)); and 
(6)November 2014 SSI survey of 2000 contact lens wearers found that 
34% said they did not receive their prescription (1-800 CONTACTS 
(RFC Comment #568, Ex. C)). As noted in the SNPRM, the manner in 
which a few of the questions were phrased in the 2014 and 2015 
surveys raised some Commission concerns, since some questions were 
leading, lacked an ``I don't know'' response option, and used a 
term--``hard copy''--which not all consumers may understand. The 
more recent surveys represented an improvement because they included 
an option for respondents to acknowledge that they do not recall 
whether they received their prescriptions, and used the term ``paper 
copy'' rather than ``hard copy.'' SNPRM, 84 FR at 24672.
---------------------------------------------------------------------------

    As for commenter criticism that consumer surveys were submitted by 
interested parties, the Commission reiterates what it stated in the 
SNPRM: while cognizant of the interests of submitting parties, the 
Commission, whenever possible, examines the underlying survey data and 
methodology to gauge a survey's usefulness and considers factors such 
as how many people are queried, how the questions are phrased, and 
whether the surveys are conducted in-house or by independent and 
established third-party polling firms.\93\ The Commission also 
recognizes that all surveys may have methodological limitations, and, 
in this instance, does not treat any one survey as controlling. The 
Commission, however, also recognizes that multiple surveys conducted by 
different sources at different times with similar results bolster the 
credibility of each individual survey, as does the fact that in this 
matter, one survey, submitted by Consumer Action and conducted by the 
third-party polling firm Caravan ORC International, is not from a party 
with a direct financial stake in the contact lens industry.\94\
---------------------------------------------------------------------------

    \93\ SNPRM, 84 FR at 24672.
    \94\ The AOA had previously noted, in response to the NPRM, that 
Consumer Action has received corporate financial support from, among 
others, 1-800 CONTACTS. Id. Consumer Action, however, is a long-
established non-profit consumer advocacy organization without a 
financial interest in the outcome of this Rule review.
---------------------------------------------------------------------------

    The Commission also notes that despite multiple opportunities and 
requests for comment since 2015, the Commission has yet to find or 
receive any reliable consumer-survey data rebutting or contradicting 
the submitted survey findings, or establishing that consumers 
consistently receive their prescriptions. The only empirical evidence 
of prescriber compliance in the record is a survey of fifty-seven 
``high volume'' prescribers submitted by AOA in response to the NPRM, 
which found that 93% responded ``yes'' when asked, ``Do you follow 
Federal law and provide patients with a copy of their contact lens 
prescription upon completion of a contact lens fitting?'' \95\ For the 
reasons stated in the SNPRM,\96\ the Commission does not accord this 
survey significant weight, and finds that it does not counter the 
multiple consumer surveys conducted over a number of years showing 
prescriber non-compliance. The Commission accords the empirical data 
from multiple consumer surveys significant weight in establishing that 
a substantial percentage of prescribers are not complying with the 
automatic-prescription-release provision of the Rule.
---------------------------------------------------------------------------

    \95\ SNPRM, 84 FR at 24672; American Optometric Association (WS 
Comment #3303, Ex. B). This survey appears to have been conducted by 
the AOA itself rather than an outside polling firm. It is not clear 
from the AOA's submission how the fifty-seven optometrists were 
selected for the survey, what it means to be a ``high volume'' 
optometrist, or why high-volume optometrists were chosen.
    \96\ SNPRM, 84 FR at 24673 (noting concerns about the small 
sample size, lack of detail as to how prescriber respondents were 
recruited, and that the way the question is phrased allows 
prescribers to truthfully answer that they provide patients with a 
copy of their prescription even if they do not do so for every 
patient, and even if they only do so when the patient requests one).
---------------------------------------------------------------------------

    Apart from the empirical data discussed above, none of the 
commenters submitted new evidence relating to prescriber compliance. 
Many individual prescribers, however, continue to comment that they 
always comply with the requirement, as do all the prescribers they 
know, and therefore they believe that the Commission is looking to 
solve a non-existent problem.\97\ Some prescribers also reiterated 
that, in their experience, consumers are well aware that they can buy 
lenses elsewhere so there is no need to educate them further about 
their rights.\98\ And a few prescribers opined that the requirement was 
a ``waste of time'' because, in their experience, consumers would 
rather not have a copy of their prescription and know that they can 
request a copy whenever they want.\99\
---------------------------------------------------------------------------

    \97\ See, e.g., Abert (SNPRM Comment #20); Hyndman (SNPRM 
Comment #21) (``every OD I know follows'' the FCLCA requirements); 
Fair (SNPRM Comment #26) (``I have ALWAYS and will continue to 
comply fully with the prescription release requirements of the 2003 
Fairness to Contact Lens Consumers Act.''); Hughes (SNPRM Comment 
#113) (most optometrists comply); Ridder (SNPRM Comment #720) (every 
patient gets their prescription whether they order or ask for it or 
not).
    \98\ Abert (SNPRM Comment #20); Jones (SNPRM Comment #48).
    \99\ Sikes (SNPRM Comment #114); Morey (SNPRM Comment #142).
---------------------------------------------------------------------------

    The Commission has considered these comments but does not believe 
they establish that prescribers, on the whole, are complying with the 
automatic-release requirement, or that consumers are fully aware of 
their prescription-portability rights. Any prescriber may indeed comply 
with the Rule but cannot speak for other eye care providers in the 
United States, nor for contact lens consumers.\100\ In addition, 
several previous comments from prescribers and prescriber organizations 
who assert that they comply with the Rule actually revealed that many 
prescribers do not fully understand or comply with the Rule's 
requirement that prescriptions be provided ``whether or not requested 
by the patient.'' \101\
---------------------------------------------------------------------------

    \100\ By one estimate, there are approximately 43,000 
optometrists and 16,700 ophthalmologists in the U.S. FTC, The 
Contact Lens Rule and the Evolving Contact Lens Marketplace, Panel 
I: Overview of the Contact Lens Marketplace Tr. at 6 (Mar. 7, 2018), 
https://www.ftc.gov/system/files/documents/public_events/1285493/panel_i_overview_of_the_contact_lens_marketplace.pdf [hereinafter 
CLR Panel I Tr.].
    \101\ See SNPRM, 84 FR at 24673-74, discussing how a number of 
prescribers commented that they always offer prescriptions to 
consumers, or provide them on request.
---------------------------------------------------------------------------

    The Commission does not accord any weight to the comments that 
consumers do not want their prescriptions. As

[[Page 50676]]

evidenced by the numerous NPRM comments from consumers urging the 
Commission to take action to ensure they are given their prescriptions, 
it cannot be doubted that many consumers have a compelling desire to 
have them.\102\ And more importantly, Congress made the determination 
that prescribers must provide patients with their prescriptions 
automatically, ``whether or not requested by the patient.'' \103\
---------------------------------------------------------------------------

    \102\ See, e.g., Boue (NPRM Comment #1806); Collins (NPRM 
Comment #1811); Hamilton (NPRM Comment #1835); Acton (NPRM Comment 
#2070); Dunbar (NPRM Comment #2652); Capuano (NPRM Comment #2722); 
Muckley (NPRM Comment #2768); Taravella (NPRM Comment #2892); 
Martinez (NPRM Comment #2894); Ballou (NPRM Comment #3331). See also 
SNPRM, 84 FR at 24671 (recounting comments from dozens of consumers 
complaining that they were denied their prescriptions).
    \103\ FCLCA, 15 U.S.C. 7601(a)(1).
---------------------------------------------------------------------------

b. Lack of Consumer Complaints as Evidence of Compliance
    Some commenters reiterated the argument--raised and discussed in 
some detail in the SNPRM \104\--that the lack of consumer complaints to 
the FTC about prescriber non-compliance is evidence that prescribers 
are releasing prescriptions as required.\105\ In the SNPRM, the 
Commission explained that it did not equate the lack of complaints with 
compliance because based on its experience, the vast majority of 
injured or impacted consumers do not register complaints with the 
government and, for various reasons, even fewer are likely to file a 
formal complaint about a prescriber's failure to release their 
prescription.\106\ The Commission also noted that more than fifty 
consumers submitted comments to the NPRM recounting personal stories of 
prescribers withholding their prescriptions, yet none of these 
commenters had previously registered complaints with the FTC.\107\
---------------------------------------------------------------------------

    \104\ SNPRM, 84 FR at 24674-75.
    \105\ Letter from Sens. Jack Reed and Sheldon Whitehouse (SNPRM 
Comment #6); Mass Mail Campaign (SNPRM Comment #25); Hanian (SNPRM 
Comment #27); Letter from 20 U.S. Senators (SNPRM Comment #38); 
Letter from Sen. Lisa Murkowski (SNPRM Comment #49); Levinson (SNPRM 
Comment #73); Cinalli (SNPRM Comment #93).
    \106\ SNPRM, 84 FR at 24674-75.
    \107\ Id. at 24675.
---------------------------------------------------------------------------

    In response, the AOA commented that if complaints to the FTC are 
not a good bellwether of prescriber compliance because consumers are 
unlikely to file formal complaints, the FTC should simplify and improve 
its complaint-reporting system.\108\ The AOA deemed it unfair for the 
Commission to rely on consumer survey data as evidence of prescribers' 
failure to release prescriptions, but not rely on the absence of 
consumer complaints as evidence that prescribers are automatically 
providing prescriptions.\109\ The AOA stated the Commission should make 
an effort to make consumer complaint data--or lack thereof--more 
representative by providing a dedicated FCLCA complaint line for 
contact-lens-related issues.\110\ At the same time, however, the AOA 
stated that since ``it is very typical'' for patients to ask for their 
prescription before their contact lens fitting is complete, consumer 
complaints cannot necessarily be viewed as accurate indications of non-
compliance.\111\
---------------------------------------------------------------------------

    \108\ American Optometric Association (SNPRM Comment #96).
    \109\ Id.
    \110\ Id.
    \111\ Id.
---------------------------------------------------------------------------

    The Commission does not find these arguments persuasive. As noted 
in the SNPRM, the Commission has gleaned, through its extensive 
experience with consumer complaints and deceptive practices, that the 
vast majority of injured or impacted consumers do not file complaints 
with the government.\112\ And with the exception of the Telemarketing 
Sales Rule (often referred to as ``Do Not Call''), consumer complaints 
about FTC rule violations are rarer still, perhaps because they require 
that consumers know what an FTC rule specifies and how it has been 
violated.\113\ While the Commission continues to regard consumer 
complaints as valuable and informative, they often represent the tip of 
the iceberg.
---------------------------------------------------------------------------

    \112\ SNPRM, 84 FR at 24675. Consumer reticence to complain, 
particularly to a government entity, is well documented. As one 
example, an FTC survey revealed that in 2017 there were an estimated 
61.8 million incidents of fraud in the United States with 
approximately 40 million individual victims and average losses of 
$100 or more, yet the FTC received just 1.2 million complaints of 
fraud from consumers, approximately 1.9% of all incidents. Keith B. 
Anderson, FTC, ``Mass Market Consumer Fraud in the United States, A 
2017 Update,'' 24, 56 (Oct. 2019); FTC, ``Consumer Sentinel Network 
Data Book 2017,'' Number of Reports by Type, https://www.ftc.gov/site-information/open-government/data-sets#csn. It is likely these 
figures actually overstate the percentage of frauds reported to the 
FTC, since the FTC's fraud surveys are limited to specific types of 
fraud, while there is no such limitation on complaints of fraud from 
consumers. See also Keith B. Anderson, FTC, ``Consumer Fraud in the 
United States: An FTC Survey'' 80 (2004), http://www.ftc.gov/reports/consumer-fraud-united-states-ftc-survey, (indicating that 
only 8.4% of U.S. fraud victims complained to an official source, 
with only 1.4% complaining to the FTC); Marc A. Grainer et al., 
``Consumer Problems and Complaints: a National View,'' 6 Advances in 
Consumer Res. 494 (1979) (noting that ``only a small, vocal minority 
of consumers complain about the problems they experience,'' and even 
fewer (less than 10% of complaints) complain to the government), 
http://acrwebsite.org/volumes/9603/volumes/v06/NA-06; John Goodman & 
Steve Newman, ``Understand Customer Behavior and Complaints,'' 
Quality Progress, Jan. 2003, at 51 (finding that for problems that 
resulted in a relatively minor inconvenience or a small loss of 
money, only 3% of consumers complained), http://web.ist.utl.pt/
~ist11038/CD_Casquilho/PRINT/qp0103goodman.pdf.
    \113\ See generally, FTC, ``Consumer Sentinel Network Data Book 
2017,'' Number of Reports by Type, https://www.ftc.gov/site-information/open-government/data-sets#csn. FTC, ``Consumer Sentinel 
Network Data Book for January-December 2016'' (2017), https://www.ftc.gov/system/files/documents/reports/consumer-sentinel-network-data-book-january-december-2016/csn_cy-2016_data_book.pdf.
---------------------------------------------------------------------------

    Furthermore, for reasons discussed in detail in the NPRM, the 
Commission does not believe its complaint-reporting system bears 
principal responsibility for the shortage of complaints about 
prescriber violations of the Contact Lens Rule.\114\ While the FTC does 
not have a dedicated complaint system solely for FCLCA violations, as 
sought by the AOA, the FTC Complaint Assistant is configured to capture 
and report all contact lens-related complaints, whether they originate 
from consumers, prescribers, sellers, or others.\115\
---------------------------------------------------------------------------

    \114\ NPRM, 81 FR at 88554-55.
    \115\ The Commission also notes that if, as the AOA asserts, 
some consumers would complain that they did not receive their 
prescriptions before they were, in fact, entitled to them, creating 
a dedicated system for FCLCA complaints would not make the number of 
complaints any more or less reflective of prescriber compliance.
---------------------------------------------------------------------------

    More to the point, multiple surveys have established that a high 
percentage of contact lens wearers (46-60%, according to submitted 
data) do not realize they are entitled to receive their 
prescription,\116\ and thus would not be aware that an incident about 
which they should complain had occurred. Many other consumers might be 
unaware of where to direct a complaint when they do not receive a 
prescription. Even consumers who are aware that they have a right to 
their prescription, and know they can file a complaint with the FTC, 
may be unlikely to file one if they ultimately receive their 
prescription after they have asked their provider for it. From the 
consumers' perspective, they have resolved their problem and may 
perceive little benefit to themselves from filing a complaint with the 
government, even if the method for filing one was more streamlined or 
convenient. Consumers may also not want to risk antagonizing their 
providers or subjecting them to legal penalties. Thus, for evaluating 
Contact Lens Rule compliance, the Commission has considered the low 
rate of consumer complaints filed with the FTC's Complaint Assistant, 
but remains convinced this is less probative of the

[[Page 50677]]

scope of the problem than other evidence.\117\
---------------------------------------------------------------------------

    \116\ SNPRM, 84 FR at 24675.
    \117\ Consumer surveys may also be more reliable since consumers 
questioned at random are less likely to have a personal interest in 
stating that they did not receive their prescription.
---------------------------------------------------------------------------

c. Number of Verifications as Evidence of Non-Compliance With the 
Automatic Prescription Release Requirement
    In the SNPRM, the Commission noted that it would accord the number 
of verifications less weight than it had in the NPRM as evidence of 
prescriber non-compliance out of a recognition that some consumers--
even if in possession of their prescription--may find it easier to type 
in their specifications than present a prescription to the seller, and 
because some online contact lens sellers do not have a mechanism for 
consumers to present their prescriptions.\118\ In its comment to the 
SNPRM, the AOA contended that the high number of verifications should 
not be accorded any weight at all for those reasons. As additional 
support for this contention, the AOA cited internal prescriber 
complaint data showing that the percentage of prescriber complaints 
about ``problematic verification calls'' has increased from roughly 6% 
to 17% in the past four years; it attributed much of this increase to 
the emergence of an online seller that does not permit patient 
prescription presentation.\119\ According to the AOA, the increase in 
complaints about verification, and the high percentage of such 
complaints about the online seller, demonstrate that a ``high volume of 
verification calls are occurring based on a prescription that was never 
written,'' and therefore the number of verification calls is ``simply 
not an appropriate measure for assessing contact lens prescription 
requirements and should be afforded no weight.'' \120\
---------------------------------------------------------------------------

    \118\ SNPRM, 84 FR at 24674.
    \119\ American Optometric Association (SNPRM Comment #96).
    \120\ Id.
---------------------------------------------------------------------------

    The Commission is aware of the issues raised by the AOA, but still 
believes that the high number of verifications is an indication that 
many consumers are not receiving their prescriptions from their 
prescribers. While a few new online sellers do not permit prescription 
presentation, these sellers' share of the overall contact lens sales is 
still quite small, even if their share of prescriber complaints, 
according to the AOA, is disproportionately large.\121\ Sellers with 
far greater sales, such as 1-800 CONTACTS and Walmart, actively 
encourage consumers to present their prescriptions, and 1-800 CONTACTS 
has even at times offered consumers discounts for doing so, because it 
is faster and less expensive than verification.\122\ Yet despite that 
encouragement, roughly 73% of overall sales by third-party sellers 
continues to occur via verification.\123\ Therefore, while the 
Commission will accord the high number of verifications less weight 
than it did in the NPRM, the Commission cannot dismiss its significance 
altogether as an indicator that consumers are not always provided their 
prescriptions, and will consider it as one of several factors in 
weighing the evidence of non-compliance in the record. The Commission 
also notes that even if the high number of verifications were 
disregarded altogether, the Commission's overall assessment of 
prescriber compliance, and the need for Rule modifications, would not 
change.
---------------------------------------------------------------------------

    \121\ 1-800 CONTACTS accounts for approximately 10% of overall 
retail contact lens sales in the United States, and as much as 60-
65% of online sales. The next closest online competitor has less 
than a quarter of the sales of 1-800 CONTACTS. See Fed. Trade 
Comm'n, The Contact Lens Rule and the Evolving Contact Lens 
Marketplace, Panel IV: Examining the Verification Process Tr. at 17 
(Mar. 7, 2018), https://www.ftc.gov/system/files/documents/public_events/1285493/panel_iv_examining_the_verification_process.pdf [hereinafter CLR 
Panel IV Tr.] (statement of Cindy Williams, 1-800 CONTACTS General 
Counsel). Walmart accounts for between 6-10% of all U.S. contact 
lens sales. Complaint Counsel's Post-Trial Brief and Exhibits, In 
the Matter of 1-800 CONTACTS, 5, (June 22, 2017), https://www.ftc.gov/system/files/documents/cases/d09372ccfindingsoffact.pdf; 
Respondent 1-800 CONTACTS Proposed Findings of Fact and Conclusions 
of Law, In the Matter of 1-800 CONTACTS, 59 (June 22, 2017), https://www.ftc.gov/system/files/documents/cases/d09372respfindingsoffact.pdf.
    \122\ National Association of Optometrists and Opticians (SNPRM 
Comment #129) (``Because of the cost and time it takes to verify a 
prescription when the script is not available, typically an online 
seller encourages such uploading and this process aids in consumer 
satisfaction and quicker, more accurate service.''); 1-800 CONTACTS 
(SNPRM Comment #135) (1-800 CONTACTS encourages its customers to 
upload their prescriptions). See also CLR Panel IV Tr., supra note 
121, at 6-7 (statement of Jennifer Sommer of Walmart); id. at 6-7, 
22 (statement of Cindy Williams of 1-800 CONTACTS).
    \123\ Paperwork Reduction Act Proposed Collection, Comment 
Request, 84 FR at 32171. See also 1-800 CONTACTS (NPRM Comment 
#3898) (stating that 70% of online orders require verification).
---------------------------------------------------------------------------

2. Comments About the Need To Improve the Commission's Ability To 
Monitor Compliance and Enforce the Rule
    Several commenters focused on the need to create an auditable 
record that would enable the Commission to monitor compliance and 
better enforce the automatic-release provision.\124\ One commenter, the 
Coalition for Contact Lens Consumer Choice, stated the Confirmation of 
Prescription Release proposal gives prescribers more leeway to design a 
system of confirmation of prescription release, but ``the important 
thing is that prescribers are still required to have patients 
affirmatively acknowledge release. . . . This is critical to increase 
enforcement of the law and to ensure that bad actors are identified 
quickly without inconveniencing those who are obeying the law.'' \125\ 
The commenter Citizen Outreach agreed, stating that the only way to 
ensure compliance with automatic release is by requiring consumers to 
sign a confirmation, and suggested that failing to require a consumer's 
signed confirmation would be a loophole ``large enough for `bad actors' 
to drive a truckload of contact lenses through.'' \126\ Likewise, the 
Attorneys General of Twenty-Seven States commented that the proposed 
Confirmation of Prescription Release modifications ``strengthen the 
Commission's ability to verify compliance with the CLR [which] ensures 
more contact lens consumers have the necessary information to make 
informed decisions, spurring competition and consumer choice.'' \127\
---------------------------------------------------------------------------

    \124\ Bosley (SNPRM Comment #58); Coalition for Contact Lens 
Consumer Choice (SNPRM Comment #89); National Hispanic Medical 
Association (SNPRM Comment #146).
    \125\ Coalition for Contact Lens Consumer Choice (SNPRM Comment 
#89).
    \126\ Citizen Outreach (SNPRM Comment #78).
    \127\ Attorneys General of 27 States (SNPRM Comment #139).
---------------------------------------------------------------------------

    Other commenters, however, felt that the FTC already has sufficient 
mechanisms to enforce the Contact Lens Rule, and should bring 
enforcement actions against so-called ``outliers'' who are violating 
the Rule, rather than imposing new requirements on all contact lens 
prescribers.\128\ Some suggested that the Confirmation of Prescription 
Release requirements should be imposed only on those found to be 
violating the prescription-release requirement.\129\ ``By refocusing 
these ideas as penalties, rather than mandates,'' according to AAO, 
``the FTC can ensure that they are not inflicting burdens on 
prescribers that have a record of compliance with the prescription 
release requirement in the

[[Page 50678]]

CLR.'' \130\ AOA believes that the FTC already has sufficient authority 
and investigative tools at its disposal, and suggested the Commission 
could use its ability to issue administrative subpoenas to investigate 
prescribers who might be violating the Rule.\131\ One prescriber also 
commented that he was skeptical that prescribers who currently 
disregard the prescription-release requirement would comply with the 
confirmation requirement,\132\ a concern previously raised and 
discussed in the SNPRM.\133\
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    \128\ Mass Mail Campaign (SNPRM Comment #25); Ohio Optometric 
Association (SNPRM Comment #47); Hardy (SNPRM Comment #60) (``Is it 
a fair idea to punish 100% of optometrists and ophthalmologists for 
the actions of a fraction of 1%''); American Optometric Association 
(SNPRM Comment #96); American Academy of Ophthalmology (SNPRM 
Comment #136) (practices will have to comply with the new burdens 
even if they have complied with prescription-release for over a 
decade).
    \129\ American Optometric Association (SNPRM Comment #96); 
American Academy of Ophthalmology (SNPRM Comment #136).
    \130\ American Academy of Ophthalmology (SNPRM Comment #136). 
The AAO suggested that the acknowledgment and record-keeping 
provisions should be imposed on prescribers who have had multiple 
complaints, and whose non-compliance was verified after allowing 
prescribers an avenue to respond and defend themselves.
    \131\ American Optometric Association (SNPRM Comment #96).
    \132\ Steinemann (SNPRM Comment #138).
    \133\ SNPRM, 84 FR at 24676, 24681.
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    Some commenters also criticized the FTC for, in their words, trying 
to acquire new authority to target small and mid-sized businesses, and 
stated this ran counter to the current trend for Congress and other 
federal agencies to ``recognize the need to alleviate the 
administrative burden that federal programs place on physician 
practices.'' \134\ And several commenters asserted that the Commission 
should not focus on enforcing requirements against prescribers while 
contact lens sellers, in their view, are violating Rule provisions in 
far greater numbers.\135\
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    \134\ American Society of Cataract and Refractive Surgery (SNPRM 
Comment #127). See also Letter from 20 U.S. Senators (SNPRM Comment 
#38); Letter from Sen. Lisa Murkowski (SNPRM Comment #49).
    \135\ McManus (SNPRM Comment #18); Ulrich (SNPRM Comment #19) 
(FTC is punishing the wrong actors); Gilberg (SNPRM Comment #46); 
American Optometric Association (SNPRM Comment #96); American 
Academy of Ophthalmology (SNPRM Comment #136).
---------------------------------------------------------------------------

    After considering these comments, the Commission continues to 
believe that some form of retained documentation is necessary to 
improve the Commission's enforcement and monitoring ability. As 
previously noted, the Commission currently faces challenges in 
enforcing the Rule. Prescribers, whether intentionally or not, 
currently can fail to release prescriptions yet risk little because 
consumers are unlikely to file a complaint if they ask for and 
subsequently receive a prescription. When a consumer does complain to 
the FTC, typically the only evidence is the word of the consumer 
against that of the prescriber, making it difficult for the Commission 
to establish with a degree of certainty whether a violation has 
occurred. This fact has played a significant role in the lack of Rule 
enforcement against prescribers over the last fifteen years, and may be 
a contributing factor to the high number of contact lens patients who 
do not currently receive their prescriptions automatically as required 
by law.
    While the AOA suggests that the Commission can use its current 
authority to issue administrative subpoenas and conduct investigative 
hearings to explore possible Rule violations, an examination of a 
prescriber's Confirmation of Prescription Release records allows a much 
more efficient means of determining whether a prescriber is complying 
with the Rule, and is much less disruptive and burdensome for the 
prescriber.\136\
---------------------------------------------------------------------------

    \136\ Serving administrative subpoenas on a wide-scale basis to 
prescribers who might not be releasing prescriptions, and requiring 
that a prescriber identify all of her contact lens customers for the 
last several months so they could be interviewed, would likely be 
criticized as excessive and heavy-handed.
---------------------------------------------------------------------------

    As for the assertion that prescribers who do not currently comply 
with prescription release are unlikely to comply with the confirmation 
requirement, the difference is that in the latter instance, there would 
be a way to check compliance. If the Commission has concerns about a 
prescriber's compliance, it can request patient confirmations or proof 
of digital delivery, or a sample of such, which should resolve most 
questions as to whether the prescriber provided prescriptions in 
accordance with the law. In this way, it would benefit prescribers 
because they would have a relatively quick and inexpensive way to show 
the FTC they complied with their automatic-release obligations.
    Further, the Commission is not attempting to expand its authority 
to target small businesses. The Commission already possesses the 
authority under the FCLCA to enforce the Rule for all contact lens 
prescribers, large and small. The Commission's Final Rule institutes a 
more effective mechanism for enforcing and evaluating the authority it 
already has. And while the Commission recognizes the need to avoid 
unnecessary government regulations, the Rule itself is, as one 
commenter put it, ``deregulatory'' in nature since its purpose is to 
restore free market competition, not to rein it in.\137\ If the Rule, 
as currently applied and enforced, is failing to meet this 
congressionally mandated goal in some respects, it is the duty of the 
Commission to find a more effective manner to realize that purpose.
---------------------------------------------------------------------------

    \137\ National Taxpayers Union (SNPRM Comment #149).
---------------------------------------------------------------------------

    With regard to the argument that it is unjust to focus on enforcing 
the automatic-release provision while not enforcing regulations that 
apply to sellers, the Commission does not agree with this premise. The 
Commission is aware of complaints about seller misconduct and is 
implementing several changes in this Final Rule to improve seller 
compliance. The Commission has also brought enforcement actions against 
sellers for violating the Rule and expects it will bring others in the 
future.\138\ Moreover, seller non-compliance does not excuse prescriber 
non-compliance, nor does it provide a justification for the Commission 
to reject taking action to improve compliance with a different 
requirement in the Rule.
---------------------------------------------------------------------------

    \138\ See, e.g., U.S. v. Duskin, No. 1:18-cv-07359 (N.D. Cal. 
Dec. 6, 2018) (consent) U.S. v. Kim, No. 1:11-cv-05723 (E.D.N.Y. Feb 
7, 2012) (consent); U.S. v. Royal Tronics, Inc, No. 0:11-cv-62491 
(S.D. Fla. Jan. 27, 2012) (consent); U.S. v. Thy Xuan Ho, No. 1:11-
cv-03419 (D. Minn. Dec. 27, 2011) (consent); U.S. v. Gothic Lens, 
LLC, No. 1:11-cv-00159 (N.D. Ga. Feb. 3, 2011) (consent); U.S. v. 
Jokeshop, LLC, No. 1:11-cv-11221 (D. Mass. Nov. 29, 2011) (consent); 
U.S. v. Contact Lens Heaven, Inc., No. 0:08-cv-61713 (S.D. Fla. Dec. 
3, 2008) (consent); U.S. v. Chapin N. Wright, II, No. 1:08-cv-11793 
(D. Mass. Oct. 31, 2008) (consent); U.S. v. BeWild, Inc., No. 2:07-
cv-04896 (E.D.N.Y. Dec. 3, 2007) (consent); U.S. v. Pretty Eyes, 
LLC, No. 1:07-cv-02462 (D. Colo. Nov. 28, 2007) (consent); U.S. v. 
Walsh Optical, Inc., No. 2:06-cv-03591 (D.N.J. Aug. 30, 2006) 
(consent); see also FTC Sends Warning Letters to Sellers of Cosmetic 
Contacts: All Contact Lens Purchases Require a Prescription from a 
Medical Professional, https://www.ftc.gov/news-events/press-releases/2019/10/ftc-sends-warning-letters-sellers-cosmetic-contacts-all-contact; FTC Issues Warning Letters Regarding the 
Agency's Contact Lens Rule, https://www.ftc.gov/news-events/press-releases/2016/04/ftc-issues-warning-letters-regarding-agencys-contact-lens-rule.
---------------------------------------------------------------------------

3. Comments About Whether the Structure of the Contact Lens Market 
Creates a Need for Verifiable Enforcement of Automatic Prescription 
Release
    Many SNPRM commenters focused on the structure of the contact lens 
market and whether a system in which prescribers sell the items they 
prescribe creates an inherent conflict that requires additional 
corrective action by the Commission.\139\ U.S. Senator Ron Wyden, for 
example, commented that

[[Page 50679]]

Congress passed the FCLCA ``to address a distorted contact lens 
marketplace that had seen freedom of choice eroded as prescribers 
largely sold the contact lenses they prescribed,'' \140\ and another 
commenter wrote, ``The system here in the U.S. for buying contact 
lenses is stacked against consumers because the people who issue you 
your prescription are also allowed to sell you contact lenses at the 
very same time. Consumers who don't know their rights are getting 
`trapped in the exam chair' so to speak, unaware that they can buy 
lenses elsewhere for lower prices.'' \141\ According to the Information 
Technology & Innovation Foundation, which describes itself as a 
nonpartisan research and educational institute, ``the profession has 
both a powerful economic interest (profits) and a powerful tool (the 
prescription) to make it more difficult for consumers to buy their 
lenses from lower-cost providers.'' \142\ In fact, a number of 
commenters support the Commission's proposal because, while regulatory 
in nature, it is designed to promote free market competition and 
protect consumers' ability to purchase from the seller of their 
choice.\143\ One commenter wrote that the only solution to what she 
termed ``the inherent structural problem that continues to cause 
friction between providers and patients'' is to prohibit prescribers 
from selling contact lenses.\144\
---------------------------------------------------------------------------

    \139\ Citizen Outreach (SNPRM Comment #78) (prescribers' ability 
to sell what they prescribe ensures a ``captive market''); Lens.com 
(SNPRM Comment #85) (``the current system is rigged against 
consumers and companies who compete with prescribers''); Coalition 
for Contact Lens Consumer Choice (SNPRM Comment #89); Taxpayers 
Protection Alliance (SNPRM Comment #118); Information Technology & 
Innovation Foundation (SNPRM Comment #103); National Hispanic 
Medical Association (SNPRM Comment #146).
    \140\ Letter from Sen. Ron Wyden (SNPRM Comment #5); see also 
Taxpayers Protection Alliance (SNPRM Comment #118) (``Congress 
passed the bipartisan Fairness to Contact Lens Consumers Act to 
protect contact lens wearers. The result was less market distortion 
and more competition, leading to more choices and lower prices for 
consumers.'').
    \141\ National Hispanic Medical Association (SNPRM Comment 
#146).
    \142\ Information Technology & Innovation Foundation (SNPRM 
Comment #103).
    \143\ See Americans for Tax Reform (SNPRM Comment #72) (``These 
changes strike the correct balance between promoting the free market 
and protecting important consumer rights.''); Citizen Outreach 
(SNPRM Comment #78); Taxpayers Protection Alliance (SNPRM Comment 
#118) (``Although we are often critical of government overreach and 
work hard to make government smaller, we believe that the FTC's 
proposed Contact Lens Rule is a government rule that works for 
taxpayers and consumers.''); National Taxpayers Union (SNPRM Comment 
#149) (``From the perspective of free-market, limited government 
advocates, the Contact Lens Rule has been one of the most balanced 
and successful examples of `deregulatory rulemaking' in the FTC's 
history.'').
    \144\ Carafas (SNPRM Comment #39).
---------------------------------------------------------------------------

    The AOA, on the other hand, disputes the premise that the contact 
lens market is unique, and argues that the fact that prescribers sell 
what they prescribe does not create an impetus for corrective 
regulation.\145\ According to the AOA, health care professionals in 
certain other areas--such as ambulatory surgery centers, orthopedic 
centers, and dental service providers, among others--also sell what 
they prescribe or recommend for treatment. Furthermore, according to 
the AOA, helping patients ``obtain treatment while in their doctor's 
office builds strong doctor-patient relationships and promotes patient-
centered care.'' \146\ The AOA therefore concludes that ``the 
Commission seems to have used the inaccurate belief that contact lens 
prescribers' role in the market is entirely unique as a justification 
for implementing new regulations on physicians,'' and thus, ``the 
entire argument for supporting prescriber rule changes must be 
reevaluated.'' \147\
---------------------------------------------------------------------------

    \145\ American Optometric Association (SNPRM Comment #96).
    \146\ Id.
    \147\ Id.
---------------------------------------------------------------------------

    Several commenters also felt that the contact lens market is 
functioning properly, as evidenced by the relatively large number of 
contact lens sellers, and by lens prices that appear competitive, and 
thus there is no need for FTC intervention to modify the Rule.\148\ As 
support for this position, the AOA submitted a price-comparison 
analysis that it stated showed that the average price difference for 
contact lenses between online sellers and office prescribers was just 
thirty-two cents.\149\ According to the AOA, this demonstrates that the 
market is highly competitive, and thus the FCLCA and Rule are working 
as intended and, consequently, there is no need for Rule modification 
and a Confirmation of Prescription Release.\150\
---------------------------------------------------------------------------

    \148\ Warner (SNPRM Comment #9); Ohio Optometric Association 
(SNPRM Comment #47); Cutter (SNPRM Comment #81); American Optometric 
Association (SNPRM Comment #96).
    \149\ American Optometric Association (SNPRM Comment #96).
    \150\ Id.
---------------------------------------------------------------------------

    The Commission does not share this assessment. While there are now 
a number of different types of sellers, and the market has become more 
competitive than it was before the Rule,\151\ prescribers still possess 
a significantly higher share of contact lens sales than online sellers, 
mass merchandisers, or retail chains,\152\ even though prescriber 
prices, on the whole, are consistently higher.\153\ The AOA's 
assessment appears to be based on lens price per-packet, rather than 
per-day or per-year.\154\ The Commission does not believe per-packet 
pricing is a fair method of comparison, because it compares some lenses 
that are effectively sold in a multi-month supply with lenses that are 
only sold as a single month's supply. The Commission conducted a re-
analysis of the AOA's data by aggregating to a consistent time-frame in 
order to compare what consumers might actually spend to wear lenses on 
a regular basis. This re-analysis--using the data supplied by AOA--
determined that the average annual prices of contacts were from $9 to 
$40 more expensive if purchased from a private practice than from the 
leading online seller.\155\ The price difference for an annual supply 
of lenses was even starker between a private practitioner and a leading 
mass merchandiser, with private practitioners averaging between $62 and 
$92 more for an annual supply.\156\ Likewise, at the Commission's 
Contact Lens Workshop, an eye care consultant presented a price survey 
for sixteen leading contact lens brands and concluded that an annual 
supply of lenses purchased online

[[Page 50680]]

averaged $17.56 less than at an independent prescribers' office, and 
lenses purchased from a shopper's club averaged $42.44 less.\157\
---------------------------------------------------------------------------

    \151\ CLR Panel I Tr., supra note 100, at 3-5 (remarks of Steve 
Kodey and accompanying slides, U.S. Optical Market Overview).
    \152\ Approximately 39% of all contact lenses sales revenue in 
the U.S. occurs at independent eye care professionals, compared to 
18% at conventional chains, 25% at mass merchants and wholesale 
clubs, and 16% online. Vision Council, U.S. Optical Market Eyewear 
Overview 4 (2018), https://www.ftc.gov/sites/default/files/filefield_paths/steve_kodey_ppt_presentation.pdf. It is also worth 
noting that while the contact lens retail market has evolved since 
2004, it may well have changed less dramatically than many other 
retail industries have since the internet revolution began diverting 
sales from brick and mortar to online merchants.
    \153\ See CLR Panel I Tr., supra note 100, at 9 (remarks of 
Wallace Lovejoy and accompanying slides, Contact Lens Price Ranges 
By Sales Channel); see also Opinion of the Commission, In the Matter 
of 1-800 CONTACTS, 4 (``Among brick-and-mortar retailers, 
independent ECPs typically have the highest prices for contact 
lenses . . . .''), https://www.ftc.gov/system/files/documents/cases/docket_no_9372_opinion_of_the_commission_redacted_public_version.pdf.

    \154\ The Commission has not been able to precisely replicate 
the thirty-two-cent-difference figure stated by AOA. But by 
comparing average packet prices in the data supplied, the difference 
between private practices and online sellers is 35 cents. For the 
reasons stated, however, the Commission does not believe this figure 
is an appropriate comparison measure.
    \155\ The average depends on whether a consumer purchased an 
annual supply all at once (in which case they received a discount 
from the online retailer) or in individual package increments. The 
Commission also notes that prices at the ``Leading Online 
Retailer,'' which, based on sales and market share, could be 1-800 
CONTACTS, might not represent the average online price for contact 
lenses, and prices at 1-800 CONTACTS, by its own admission, are 
typically higher than those of both other online sellers and retail 
club stores. Brief of 1-800 CONTACTS, 1-800 CONTACTS v. Federal 
Trade Commission (2d Cir. June 12, 2019); see also Opinion of the 
Commission, In the Matter of 1-800 CONTACTS, 4, https://www.ftc.gov/system/files/documents/cases/docket_no_9372_opinion_of_the_commission_redacted_public_version.pdf.

    \156\ The data derives from the ABB Optical Group, Soft Lens 
Retail Price Monitor (First Quarter 2019).
    \157\ CLR Panel I Tr., supra note 100, at 9 (remarks of Wallace 
Lovejoy and accompanying slides, Contact Lens Price Ranges By Sales 
Channel).
---------------------------------------------------------------------------

    There can be valid reasons for differences in prices among sellers 
(some sellers may offer more convenience, options, or better customer 
service), and the Commission does not view price differences between 
private eye care practitioners and third-party sellers, in and of 
itself, as dispositive evidence that the market is not functioning in a 
competitive manner. But the Commission disagrees that the submitted 
pricing data is proof that the market is functioning in a perfectly 
competitive manner, and is proof that prescribers are providing 
patients with their prescriptions.
    The Commission is also aware that there are other health care 
professionals who may sell what they prescribe or recommend for 
treatment, and has not based its proposal solely on a belief that 
contact lens prescribers' role and market is unique. Rather, the 
Commission has considered the structure of the market as a contributing 
factor in an overall evaluation of the need for improved Rule 
compliance and enforcement. It must be acknowledged--as it was by 
Congress when it enacted the FCLCA and directed the FTC to implement 
the Rule--that it is not in prescribers' self-interest for their 
patients to take prescriptions elsewhere to buy lenses.\158\ And while 
it is true that some health care professionals in other fields sell 
products that they prescribe or recommend for treatment, the sheer 
volume of contact lens prescribers' revenue and profit derived from the 
sale of contact lenses--16-32% of revenue, by some accounts \159\--
creates a powerful incentive to keep those sales in house.
---------------------------------------------------------------------------

    \158\ See H.R. Rep. No. 108-318, at 4-5 (stating that ``[t]he 
practice of optometrists withholding the prescription has limited 
the consumer's ability to shop for the best price and has impacted 
competition'' and that obstacles to free market competition are 
rooted in an ``inherent conflict of interest'' in that ``[u]nlike 
medical doctors who are prohibited from selling the drugs they 
prescribe, eye doctors and optometrists . . . are able to fill the 
contact lens prescriptions they write''); see also 149 Cong. Rec. 
H11564-65 (daily ed. Nov. 19, 2003) (statement of Rep. Stark) (``Eye 
doctors cite health concerns, but the fact is they have a strong 
financial incentive to restrict consumer access to the contact lens 
market.'').
    \159\ Harris Williams & Co., Vision Industry Update, at 4 (Mar. 
2017); Harris Williams & Co., Vision Industry Overview, at 3 (Jan. 
2015). Contact Lens Spectrum has estimated the percentage of gross 
practice revenue from contact lenses to be 30%, and the net practice 
revenue at 26%, but the estimate does not specify how much of that 
was derived from sales of lenses versus professional fees for 
contact lens fittings and examinations. Contact Lens Spectrum, at 19 
(Jan. 2019), https://bt.editionsbyfry.com/publication/frame.php?i=552776&p=&pn=&ver=html5. See also Ken Kriviac, How to 
Hubble-Proof Your Contact Lens Practice, Review of Optometric 
Business (Jan. 17, 2018) (optometrist stating that 17% of his 
practice's total revenue is generated from the sale of contact lens 
related materials, with another 8% from related professional fees), 
https://reviewob.com/can-hubble-proof-contact-lens-practice/.
---------------------------------------------------------------------------

4. Comments About the Text of the Proposed Confirmation of Prescription 
Release, and the Options To Include the Confirmation as Part of a 
Patient's Prescription or Sales Receipt
    As noted previously, unlike the two-sentence signed-acknowledgment 
proposal from the NPRM,\160\ the SNPRM's Confirmation of Prescription 
Release proposal did not mandate specific text for the patient's signed 
confirmation. Instead, the SNPRM, for convenience, provided optional 
sample language that prescribers could use but left it up to individual 
prescribers to draft their own confirmation language if they so 
preferred.\161\ The Commission proposed this flexibility in response to 
commenter concerns that the language of the NPRM's signed-
acknowledgment interfered with the prescriber-patient relationship by 
imparting the impression that prescribers had done something wrong. By 
permitting prescribers to draft their own confirmation language or use 
the provided, shortened sample language, the Commission aimed to allow 
prescribers to use wording that they believe would be less likely to 
reflect negatively on the prescribers' conduct.\162\ The Commission 
also proposed to allow prescribers to include the confirmation as part 
of a patient's prescription or sales receipt.\163\
---------------------------------------------------------------------------

    \160\ NPRM, 81 FR at 88559.
    \161\ SNPRM, 84 FR at 24683. The sample language provided by the 
Commission consisted of the following: ``My eye care professional 
provided me with a copy of my contact lens prescription at the 
completion of my contact lens fitting.''
    \162\ Id.
    \163\ Id.
---------------------------------------------------------------------------

    One commenter, the National Association of Optometrists and 
Opticians (``NAOO''), praised the new options and flexibility, stating 
it would ``assist the industry in, and lighten the burdens of, 
compliance.'' \164\ The NAOO also approved of the FTC sample 
confirmation language, calling it a ``concise statement of the point of 
the Rule,'' and predicting it would be used by most of its 
members.\165\ The NAOO did suggest, however, that to avoid potential 
confusion from a confirmation statement containing additional 
acknowledgments or unnecessary information, the Rule should clarify 
that the patient's confirmation statement should not contain any 
message or acknowledgment other than that relating to confirmation of 
prescription release.\166\ The NAOO also suggested that in instances 
where a consumer refused to sign the confirmation, the Commission 
should allow the prescriber to note the refusal and the reason for it 
as evidence of compliance.\167\
---------------------------------------------------------------------------

    \164\ National Association of Optometrists and Opticians (SNPRM 
Comment #129).
    \165\ Id.
    \166\ Id.
    \167\ Id.
---------------------------------------------------------------------------

    Other commenters felt that even with the new confirmation-language 
flexibility, requiring patients to confirm receipt of their 
prescriptions would imply that prescribers had been improperly 
withholding them.\168\ One prescriber commented, ``Why would I need to 
get a signature of my patient to confirm they received a prescription 
unless I was doing something wrong that required proof.'' \169\ Others 
felt that the requirement still unfairly forced them to aid their 
competition by reminding consumers that they could take their 
prescriptions to other sellers to have them filled.\170\
---------------------------------------------------------------------------

    \168\ Abert (SNPRM Comment #20) (``The additional time required 
for this unneeded paperwork would disrupt the patient-doctor 
relationship by communicating to the patients that they should be 
wary of their physician, and assume that their doctor is a violator 
of Federal law.''); Ohio Optometric Association (SNPRM Comment #47) 
(``The proposal, even in its latest form, will . . . cast public 
doubt on the integrity of the optometrists and ophthalmologists . . 
. .''); Cutter (SNPRM Comment #81); Ritzel (SNPRM Comment #157) 
(``The idea of me having to have a patient sign a form certifying 
that I actually gave them a copy of their contact lens 
prescription--because ``Big Brother'' is watching--is insulting to 
myself as a person, and to my profession.'').
    \169\ Cutter (SNPRM Comment #81).
    \170\ Sanders (SNPRM Comment #61) (``It's akin to having Target 
have a big sign next to their own that states, `You can get 
everything here at Walmart as well!' ''); Poulter (SNPRM Comment 
#131) (``It is no more necessary for providers to inform patients of 
their right to purchase elsewhere than it is for a dentist to let a 
patient know he can purchase a crown from another party, then return 
to the dentist to have it placed.'').
---------------------------------------------------------------------------

    In contrast, some commenters felt that allowing prescribers to 
draft their own language, and removing the second sentence of the 
acknowledgment (the requirement that patients confirm the statement: 
``I understand I am free to purchase contact lenses from the seller of 
my choice''), greatly reduced the effectiveness of the new 
proposal.\171\ The online seller 1-800 CONTACTS, in particular, 
asserted that removal of the second sentence significantly reduced the 
educational benefit of the

[[Page 50681]]

requirement since consumers who were unaware they had a right to their 
prescription would not be so informed. 1-800 CONTACTS also stated that 
eliminating the second sentence made it less likely prescribers would 
release prescriptions directly after the fitting is complete, and 
prescribers would instead wait until patients had purchased lenses 
before giving them their prescriptions and obtaining Confirmations of 
Prescription Release.\172\ 1-800 CONTACTS also said there is no reason 
the second sentence would ``sow consumer doubt or harm prescribers' 
reputations'' unless the prescriber had previously been withholding 
prescriptions.\173\ The online seller therefore proposed that instead 
of leaving the wording up to prescribers, the confirmation requirement 
should again specify the wording required and include the second 
sentence from the acknowledgment proposal--albeit with a minor 
adjustment--so as to state, ``I understand that I am free to purchase 
contact lenses from my eye care professional or the seller of my 
choice.'' \174\ Inclusion of the option to purchase from the ``eye care 
professional'' might alleviate some concern that the notice was 
instructing consumers to buy from someone other than their prescriber.
---------------------------------------------------------------------------

    \171\ Consumer Reports (SNPRM Comment #133); 1-800 CONTACTS 
(SNPRM Comment #135).
    \172\ 1-800 CONTACTS (SNPRM Comment #135) (According to a survey 
conducted by an independent polling firm on behalf of 1-800 
CONTACTS, 38% of consumers who are given their prescription receive 
it at the same time or only after they have already purchased lenses 
from the prescriber).
    \173\ Id. (``Because the Confirmation does not require that 
prescribers provide consumers with any notice of their rights, but 
merely requires that consumers acknowledge receipt by signature, it 
is far less likely to either educate consumers or discourage 
prescribers from pressuring consumers into buying lenses.'').
    \174\ 1-800 CONTACTS (SNPRM Comment #135).
---------------------------------------------------------------------------

    The consumer advocacy organization Consumer Reports also opposed 
permitting prescribers to devise their own language of confirmation, 
and opposed allowing prescribers to make the confirmation part of a 
prescription copy or sales receipt (Confirmation of Prescription 
Release options (B) and (C)).\175\ Instead, Consumer Reports stated 
that the confirmation should remain a stand-alone document, and 
suggested requiring the statement, ``My eye care professional provided 
me with a copy of my contact lens prescription at the completion of my 
contact lens fitting. I should give a copy of my prescription to the 
contact lens seller I choose.'' \176\ According to Consumers Reports, 
there are ``clear advantages to standardized wording,'' and by 
instructing consumers to present their prescription to sellers, this 
would further promote the Commission's goal of reducing 
verifications.\177\ Consumer Reports opined that a statement of 
confirmation added to the prescriber's copy of the prescription, or 
added to an examination receipt, might not be noticed by the 
patient.\178\
---------------------------------------------------------------------------

    \175\ Consumer Reports (SNPRM Comment #133).
    \176\ Id.
    \177\ Id.
    \178\ Id.
---------------------------------------------------------------------------

    Some commenters also opined that when prescribers satisfy the 
confirmation by releasing the prescription electronically (option (D)), 
prescribers should still provide consumers with a statement advising 
them that they have a right to their prescription and have the option 
to buy lenses elsewhere.\179\ And many commenters raised concerns about 
whether to allow option (D) altogether, as discussed in more detail 
below.
---------------------------------------------------------------------------

    \179\ Id.; 1-800 CONTACTS (SNPRM Comment #135).
---------------------------------------------------------------------------

    With respect to allowing options (B) and (C), and permitting 
prescribers to craft their own wording, the Commission acknowledges 
that the confirmation proposal may provide less of an immediate 
educational benefit than the NPRM's proposed Signed Acknowledgment. By 
permitting prescribers to include the confirmation on the prescription 
itself, or on a sales receipt, it is indeed possible that some 
consumers will fail to understand its purpose, or what it is they are 
signing. And by not requiring that the confirmation include a sentence 
specifically informing consumers of their right to have prescriptions 
filled elsewhere, and not requiring a notice to this effect with 
digital delivery, some consumers may remain unaware of prescription 
portability.
    The Commission, however, continues to believe that the benefit from 
providing prescribers with greater flexibility, reducing the possible 
paperwork burden, and limiting potential interference with the 
prescriber-patient relationship, justifies the trade-off. As noted in 
the SNPRM, the Confirmation of Prescription Release will maintain much 
of the effectiveness and enforceability of the Signed Acknowledgment, 
while reducing the impact on prescribers.\180\
---------------------------------------------------------------------------

    \180\ SNPRM, 84 FR at 24683.
---------------------------------------------------------------------------

    The Commission also does not believe that requiring patients to 
sign a confirmation will provoke doubts about the integrity of their 
prescribers. While patients might draw the conclusion that some 
prescribers have not always automatically released prescriptions, there 
is little reason for patients to conclude that their individual 
prescriber had failed to do so, especially if their prescriber has 
always provided them with their prescription. It seems more likely that 
patients may simply conclude that the law has changed. Furthermore, as 
noted in the SNPRM, consumers are accustomed to signing acknowledgments 
or receipts. Many pharmacists require patients to acknowledge that they 
do not have questions upon receiving a prescription; physicians' 
offices require visitors to sign in; and patients are accustomed to 
signing HIPAA acknowledgment forms signifying they received a 
provider's Notice of Privacy Practices.\181\ The Commission is not 
aware of any evidence that such requirements sow distrust on the part 
of the person signing the receipt. The Commission believes this will 
hold true for the Confirmation of Prescription Release, particularly 
since prescribers can devise their own language of confirmation. The 
Commission also believes that while it may be advisable for providers 
to avoid potential patient confusion by not including any other 
acknowledgments or information on the confirmation document, it is not 
necessary to expressly prohibit this in the Rule at this time. Such a 
prohibition might limit the flexibility of the new proposal, and could 
make it more difficult for providers to avail themselves of options (B) 
and (C) by including patient confirmation as part of a sales receipt or 
prescription copy. Moreover, as noted in the SNPRM, while prescribers 
are free to provide their own language, it would remain a violation for 
the receipt to include additional information proscribed by the Rule, 
such as liability waivers or agreements to purchase lenses from the 
prescriber.\182\
---------------------------------------------------------------------------

    \181\ Id. at 24682.
    \182\ Id. at 24683.
---------------------------------------------------------------------------

5. Comments About Option (D) and Using Electronic Delivery for 
Confirmation of Prescription Release
    In the SNPRM, the Commission proposed modifying the Rule to allow 
prescribers to satisfy the automatic prescription release requirement 
by providing a digital copy in lieu of a paper copy when the patient 
gives verifiable affirmative consent.\183\ The Commission noted that 
using online patient portals and other electronic methods to complete 
the automatic prescription release offered potential benefits for 
sellers, prescribers, and patients.\184\ Patients would be able to

[[Page 50682]]

access their prescriptions and have electronic copies to send to 
sellers. With the prescription, a seller would no longer need to submit 
a verification request, which would benefit prescribers by reducing the 
volume of requests. However, there were also some concerns about 
portals, including that patients may not be aware of the portal or have 
difficulty accessing it.\185\ Because the Commission did not have 
sufficient information to determine whether solely posting a contact 
lens prescription on a patient portal would be sufficient to satisfy 
the Rule's obligation for prescribers to provide a copy of the 
prescription after completing the contact lens fitting, the Commission 
sought comments on its proposed Rule modification.\186\ The Commission 
also asked for comments on whether prescribers should be required to 
maintain any records documenting a patient's verifiable consent to 
receive a prescription electronically.\187\
---------------------------------------------------------------------------

    \183\ Id. at 24669.
    \184\ Id. at 24668.
    \185\ Id.
    \186\ Id. at 24669.
    \187\ Id. at 24690.
---------------------------------------------------------------------------

a. Use of Patient Portals and Patient Consent
    Many commenters expressed support for allowing prescribers to use 
electronic methods, such as a patient portal, to provide prescriptions 
to patients who consent.\188\ Among the potential benefits, commenters 
noted the reduction in verification calls or requests for additional 
copies, easier access to and use of a prescription, lower costs, and 
flexibility for patients and prescribers.\189\ Currently, many 
prescribers already use a portal or other electronic methods to 
communicate with and, in some instances, provide prescriptions to their 
patients,\190\ and use of electronic methods is expected to increase in 
the future.\191\ For example, one survey found that approximately 64.2% 
of eye care professionals communicated with patients by text message, 
of which 26.4% used it to respond to personal questions about the 
patient's eye health.\192\ Because a significant percentage of eye care 
providers already use electronic communications and portals, the 
Commission believes that the required, automatic prescription release 
could be completed effectively through a digital copy when a patient 
provides verifiable affirmative consent. Verifiable affirmative consent 
means that a patient must have provided his or her consent to the 
prescriber in a way that can be later confirmed. A signed consent form, 
an email from the patient to the prescriber, or an audio recording from 
a telephone conversation with a patient would be examples of verifiable 
affirmative consent. Notification through, for example, a posted office 
sign or a general written notice of office policies or practices would 
not constitute affirmative consent because patients have not indicated 
to the prescriber whether or not they consent.
---------------------------------------------------------------------------

    \188\ See, e.g., Liao (SNPRM Comment #2); Coalition for Contact 
Lens Consumer Choice (SNPRM Comment #89); Consumer Action (SNPRM 
Comment #101); Information Technology & Innovation Foundation (SNPRM 
Comment #103); Alcon Vision, LLC (SNPRM Comment #117); National 
Association of Optometrists and Opticians (SNPRM Comment #129); 
CooperVision, Inc. (SNPRM Comment #130) (noting that electronic 
delivery of a prescription is ``a common-sense, low burden method of 
giving patients better access to their prescriptions''); 1-800 
CONTACTS (SNPRM Comment #135); Attorneys General of 27 States (SNPRM 
Comment #139); National Hispanic Medical Association (SNPRM Comment 
#146); Backus (WS Comment #1650).
    \189\ Americans for Tax Reform (SNPRM Comment #72); Coalition 
for Contact Lens Consumer Choice (SNPRM Comment #89); Consumer 
Action (SNPRM Comment #101); Information Technology & Innovation 
Foundation (SNPRM Comment #103); National Association of 
Optometrists and Opticians (SNPRM Comment #129); CooperVision, Inc. 
(SNPRM Comment #130); Consumer Reports (SNPRM Comment #133).
    \190\ See, e.g., Coalition for Contact Lens Consumer Choice 
(SNPRM Comment #89); American Optometric Association (SNPRM Comment 
#96); National Association of Optometrists and Opticians (SNPRM 
Comment #129) (stating that practice management systems and 
electronic health records are easily available at reasonable 
prices); Sikes (SNPRM Comment #114); Klepfisz (SNPRM Comment #140); 
Eklund (WS Comment #502); Holland (WS Comment #513); Reed (WS 
Comment #749); Gitchell (WS Comment #759); Andrews (WS Comment 
#1014); Carvell (WS Comment #1021); Cecil (WS Comment #1892); Kuryan 
(WS Comment #3472); Hopkins (NPRM Comment #184); Wilson (NPRM 
Comment #1310); Grove (NPRM Comment #1702); MacDonald (NPRM Comment 
#2118); Andrus (NPRM Comment #3345).
    \191\ FTC, The Contact Lens Rule and the Evolving Contact Lens 
Marketplace, Panel V: Prescription Release & Consumer Choice Tr. at 
18-21 (Mar. 7, 2018), https://www.ftc.gov/system/files/documents/public_events/1285493/panel_v_prescription_release_and_consumer_choice.pdf [hereinafter 
CLR Panel V Tr.].
    \192\ Jobson Research, ECP Digital Solutions Study (2019) (also 
finding that of those surveyed, approximately 74.4% contacted their 
patients by email, of which 45.5% used it to respond to personal 
questions about the patient's eye health). As noted in the SNPRM, 
another survey showed that approximately 30% of patients were 
offered access to a portal during their last eye exam and that 29% 
chose to use the portal. SNPRM, 84 FR at 24668 n.50.
---------------------------------------------------------------------------

    Several commenters supported the use of electronic methods, but had 
a variety of concerns or proposed changes. Some thought patients might 
prefer a paper copy instead of an electronic copy of their 
prescription, including people who are older, reluctant to use 
technology or worried about online privacy or identity theft, unable to 
navigate a cumbersome portal, without internet or smartphone access, or 
not proficient in English.\193\ The Commission shares these concerns 
and the Final Rule thus maintains the ability for patients who prefer a 
paper copy for any reason to obtain such a copy. Even if a prescriber 
offers electronic delivery, a patient could decline to provide consent. 
Likewise, prescribers who are concerned about the security or costs of 
electronic methods can continue providing paper copies.\194\ The Final 
Rule neither compels prescribers to offer prescription release by an 
electronic method nor requires that patients accept their prescription 
by electronic method when offered by the prescriber.
---------------------------------------------------------------------------

    \193\ R Street (SNPRM Comment #15); Americans for Tax Reform 
(SNPRM Comment #72); Coalition for Contact Lens Consumer Choice 
(SNPRM Comment #89); American Optometric Association (SNPRM Comment 
#96); National Hispanic Medical Association (SNPRM Comment #146); 
National Taxpayers Union (SNPRM Comment #149).
    \194\ American Optometric Association (SNPRM Comment #96); 
American Society of Cataract and Refractive Surgery (SNPRM Comment 
#127).
---------------------------------------------------------------------------

    One seller urged the Commission to require that the prescribers, 
when seeking affirmative consent, identify to patients the specific 
method of electronic delivery that would be used.\195\ The Commission 
believes that requiring prescribers to identify the specific method or 
methods \196\ would allow patients to make a more informed decision and 
increase awareness of how the prescription would be provided if they 
were to consent. It is also possible that a patient prefers one method 
of electronic communication, but not others.\197\ Therefore, the 
Commission is amending the definition of ``Provide to the patient a 
copy'' to require that prescribers who choose to offer an electronic 
method, identify the specific method or methods to be used and, if a 
patient consents, have evidence of verifiable affirmative consent to 
the identified method or methods.
---------------------------------------------------------------------------

    \195\ 1-800 CONTACTS (SNPRM Comment #135).
    \196\ A request for consent that states that the prescription 
would be delivered electronically, but does not state the method, 
such as email, text, or portal, would not be adequate. If more than 
one method is offered, prescribers must specifically identify each 
one.
    \197\ 1-800 CONTACTS (SNPRM Comment #135).
---------------------------------------------------------------------------

    Regarding patient portals specifically, some commenters expressed 
concerns that: (1) Patients would be unaware that their prescription is 
on a portal; (2) there could be a delay in posting prescriptions to the 
portal; or (3) prescribers might intentionally make portals difficult 
to use, post prescriptions without telling their patients, or confuse 
patients into thinking that they must buy lenses from

[[Page 50683]]

them.\198\ They urged the Commission to require that prescribers notify 
patients when a prescription is available on the portal, provide 
instructions on how to access the portal, or confirm that the 
prescription has been received.\199\ The Commission believes that the 
Final Rule provides adequate safeguards for patients who have opted to 
receive their prescription on a portal. As noted in the SNPRM, the use 
of a portal or other electronic method does not change the timing of 
when a prescriber must provide a copy of the contact lens 
prescription.\200\ A prescriber must provide the prescription 
immediately after the completion of the contact lens fitting, or in the 
case of a renewal, when a prescriber determines that no change to the 
existing prescription is required.\201\ Furthermore, prescribers can 
only use a portal to satisfy their obligation under Sec.  315.3(a)(1) 
when they have affirmative consent to the specific method or methods of 
electronic delivery. Therefore, patients should be aware that their 
prescription will be provided electronically using the method to which 
they consented. The Rule also requires that patients be able to access, 
download, and print the prescriptions from the portal.\202\ If patients 
were to have any problems with using the portal, they could revoke 
their consent and request a paper copy.\203\ Notwithstanding these 
safeguards, the Commission encourages prescribers to provide 
instructions to patients who may encounter difficulties accessing their 
portal. The Commission believes that the Rule, with the modification to 
require that prescribers identify the specific electronic method to be 
used, balances the interests of prescribers and patients by offering a 
flexible method that could reduce the burden on prescribers and allow 
patients greater access to their prescriptions.\204\
---------------------------------------------------------------------------

    \198\ R Street (SNPRM Comment #15); Lens.com (SNPRM Comment 
#85); Coalition for Contact Lens Consumer Choice (SNPRM Comment 
#89); Consumer Action (SNPRM Comment #101); Information Technology & 
Innovation Foundation (SNPRM Comment #103); 1-800 CONTACTS (SNPRM 
Comment #135); National Hispanic Medical Association (SNPRM Comment 
#146); Senator Mike Lee (SNPRM Comment #159).
    \199\ R Street (SNPRM Comment #15); Information Technology & 
Innovation Foundation (SNPRM Comment #103); Consumer Reports (SNPRM 
Comment #133); 1-800 CONTACTS (SNPRM Comment #135); Senator Mike Lee 
(SNPRM Comment #159).
    \200\ SNPRM, 84 FR at 24669 n.54.
    \201\ Id.
    \202\ The Commission does not have any evidence that prescribers 
are intentionally making portals difficult for their patients to 
use. However, such conduct, if it were to occur, could violate the 
Rule because patients would not be able to access their 
prescription.
    \203\ Patients could also request an additional copy under 16 
CFR 315.3(a)(3).
    \204\ Consumer Action appears to encourage the Commission to 
provide further guidance on portal design in the Rule. SNPRM Comment 
#101. Given the potential for future developments in technology and 
the differences among prescribers' practices and current software, 
the Commission declines to mandate requirements on portal design. 
See CLR Panel V Tr., supra note 191, at 18-21 (discussing the 
variety of electronic-health-records programs available from 
``hundreds'' of ECH vendors, with each program based on different 
standards and providing varying degrees of functionality and 
compatibility).
---------------------------------------------------------------------------

    Furthermore, some commenters want a paper copy to be provided in 
addition to the electronic copy,\205\ but the Commission declines to 
adopt this suggestion because requiring both copies would undercut a 
benefit of using electronic methods and be unnecessary for patients who 
have expressed a preference for an electronic copy. Finally, a 
commenter states that telemedicine prescribers should not be required 
to provide paper prescriptions.\206\ Although patients who opt for 
telemedicine might be more comfortable with technology and receiving 
health care online,\207\ some patients may still prefer their 
prescription on paper. Since telemedicine providers should have been 
providing a paper copy under the current Rule, continuation of this 
practice, when a patient does not consent to electronic delivery, 
should not be impractical or overly burdensome.
---------------------------------------------------------------------------

    \205\ Americans for Tax Reform (SNPRM Comment #72); Lens.com 
(SNPRM Comment #85); Coalition for Contact Lens Consumer Choice 
(SNPRM Comment #89); Consumer Action (SNPRM Comment #101); Consumer 
Reports (SNPRM Comment #133).
    \206\ Simple Contacts (SNPRM Comment #87).
    \207\ Id.
---------------------------------------------------------------------------

b. Requirement To Maintain Records of Patient Consent
    In the SNPRM, the Commission proposed requiring that prescribers 
obtain affirmative consent in order to provide a prescription 
electronically, but did not require that prescribers maintain evidence 
of consent. In response, several commenters have urged the Commission 
to require that prescribers maintain records pertaining to patients' 
affirmative consent.\208\ According to some of these commenters, a 
record of consent would allow more effective compliance monitoring, 
while the burden of storing such a record would be minimal.\209\ By 
contrast, the AOA states that prescribers should not be required to 
maintain records of consent because the AOA believes it would be 
burdensome \210\ and ``provides no obvious benefit to the patient'' 
since ``the likelihood of harm from a patient receiving a contact lens 
prescription electronically is low to nonexistent.'' \211\ However, 
other commenters countered that there is a potential for harm since 
patients who do not consent might not realize that they received their 
prescription electronically, or might be unable to access it.\212\
---------------------------------------------------------------------------

    \208\ Consumer Action (SNPRM Comment #101); Information 
Technology & Innovation Foundation (SNPRM Comment #103); National 
Association of Optometrists and Opticians (SNPRM Comment #129); 
Consumer Reports (SNPRM Comment #133); 1-800 CONTACTS (SNPRM Comment 
#135).
    \209\ Consumer Action (SNPRM Comment #101) (stating that the 
cost of storing digital records is not burdensome); Information 
Technology & Innovation Foundation (SNPRM Comment #103) (stating 
that the cost of storing a consent form would be virtually zero).
    \210\ See also American Society of Cataract and Refractive 
Surgery (SNPRM Comment #127) (discussing the administrative burden 
related to maintaining records of consent). Other commenters contend 
that the burden of storing these records would be minimal. 
Information Technology & Innovation Foundation (SNPRM Comment #103).
    \211\ American Optometric Association (SNPRM Comment #96). The 
AOA also asserts that ``[p]atients do not have to consent to the 
electronic delivery of other prescriptions.'' However, there may be 
differences between contact lens prescriptions and some other types 
of medical prescriptions. In many instances, other types of 
prescriptions being delivered electronically are not being sent to a 
patient, but rather to a pharmacy that then fills the prescription. 
When a prescription is sent to a pharmacy, the patient would likely 
have selected or have knowledge of the receiving pharmacy. In 2013, 
57% of prescriptions nationally were sent electronically from 
physicians to pharmacies, with the rate in some states over 80%. 
U.S. Dep't of Health & Human Servs., The Office of the National 
Coordinator for Health Information Technology, ``E-Prescribing 
Trends in the United States'' 8 (2014) (stating also that 96% of all 
community pharmacies in the U.S. accept e-prescriptions).
    \212\ R Street (SNPRM Comment #15); Coalition for Contact Lens 
Consumer Choice (SNPRM Comment #89); Consumer Action (SNPRM Comment 
#101); National Hispanic Medical Association (SNPRM Comment #146); 
National Taxpayers Union (SNPRM Comment #149).
---------------------------------------------------------------------------

    The Commission finds persuasive the arguments in favor of requiring 
a record of patient consent to electronic delivery. The burden of 
retaining a record of patient consent should be minimal, since 
prescribers who opt for electronic delivery of prescriptions will, in 
all likelihood, obtain and/or store such consent electronically. Even 
if they do not, it should not take any longer to obtain and store 
patient consent to electronic delivery than it would to obtain and 
store a patient's Confirmation of Prescription Release via options (A), 
(B) or (C). Furthermore, a prescriber is not required to offer patients 
a digital prescription. Rather, it is at his or her option. Moreover, 
consent to receipt of a digital copy would aid in enforcing the Rule 
since,

[[Page 50684]]

without a record of consent, there would be no way for the Commission 
to confirm that patients who were given their prescriptions 
electronically agreed to such electronic delivery, and had the ability 
to access their prescriptions in this manner. The Final Rule will thus 
require that prescribers keep records or evidence of a patient's 
affirmative consent to a digital copy for at least three years. 
Although some commenters have sought longer retention periods,\213\ 
three years is a time period consistent with other recordkeeping 
obligations in the Rule.
---------------------------------------------------------------------------

    \213\ Information Technology & Innovation Foundation (SNPRM 
Comment #103) (requesting five years); 1-800 CONTACTS (SNPRM Comment 
#135) (requesting that the record be kept as long as the affirmative 
consent is active). State laws could require that prescribers 
maintain these records for longer than three years.
---------------------------------------------------------------------------

6. Comments About Alternatives to the Confirmation of Prescription 
Release
    In addition to the suggestions--discussed previously--that the 
Commission increase its enforcement of the current Rule, or impose new 
requirements only as a penalty for specific providers found in non-
compliance,\214\ some commenters proposed alternative means of ensuring 
that consumers receive their prescriptions.
---------------------------------------------------------------------------

    \214\ American Optometric Association (SNPRM Comment #96).
---------------------------------------------------------------------------

a. Signage
    Several commenters reiterated the idea--raised and discussed in 
some detail in the SNPRM \215\--that instead of requiring a patient 
acknowledgment or confirmation, the Commission ought simply to require 
that prescribers post signs informing consumers of their right to their 
prescriptions.\216\ In its SNPRM, the Commission acknowledged that 
signage offers some of the benefits of a patient confirmation, but 
concluded that it had significant drawbacks: In the particular 
environment of a prescriber's office, far fewer consumers would learn 
of their rights from a sign than from being asked to sign a receipt; 
signage would serve as less of a reminder to prescribers and their 
staff to release prescriptions; signage would do nothing to aid the 
Commission in monitoring and enforcing the prescription-release 
requirement; and relying on patients to notice a sign and ask for their 
prescriptions put the onus on consumers to enforce the Rule, and would 
effectively amend the FCLCA's automatic-release provision to release-
upon-request, a statutory revision only Congress can make.\217\ The 
Commission also noted that relying on consumers to ask for their 
prescriptions is problematic since consumers might not see the sign, or 
might be uncomfortable asking their prescribers for their 
prescriptions.\218\ Based on those reasons, the Commission declined to 
propose signage as an alternative to a Confirmation of Prescription 
Release.\219\
---------------------------------------------------------------------------

    \215\ SNPRM, 84 FR at 24679.
    \216\ Letter from 20 U.S. Senators (SNPRM Comment #38); Letter 
from Sen. Lisa Murkowski (SNPRM Comment #49); Cutter (SNPRM Comment 
#81); American Optometric Association (SNPRM Comment #96); Gilbert 
(SNPRM Comment #119); Patel (SNPRM Comment #123); Letter from N.D. 
State Sen. Judy Lee (SNPRM Comment #161).
    \217\ SNPRM, 84 FR at 24682-83.
    \218\ Id. at 24682.
    \219\ Id. at 24682-83.
---------------------------------------------------------------------------

    Some SNPRM commenters agreed with the Commission's position, 
stating that ``requiring prescribers to post signs doesn't work,'' 
\220\ and asserting that in California, where a state law requires 
contact lens prescribers to post signs detailing patient rights, some 
optometrists fail to comply, or post the signs in locations consumers 
are unlikely to see them.\221\ In contrast, other commenters contended 
that the Commission should reconsider the signage alternative, 
reiterating that it would be less burdensome and intrusive for 
prescribers and could address the FTC's educational objectives without 
costly regulation.\222\ The AOA also took issue with the fact that the 
Commission cited HHS's implementation of a signed-acknowledgment for a 
prescriber's HIPAA obligation instead of opting for signage.\223\ 
According to the AOA, anything HHS concluded when it constructed the 
HIPAA signed-acknowledgment is no longer relevant since HHS is now 
considering eliminating the requirement and switching to signage in 
order to reduce the burden on health care practitioners.\224\ 
Furthermore, according to the AOA, ``the physician community is united 
in its belief'' that the HIPAA signed-acknowledgment should be 
eliminated, and this shows that such acknowledgment requirements 
constitute poor policy, and signage is a better option.\225\
---------------------------------------------------------------------------

    \220\ Coalition for Contact Lens Consumer Choice (SNPRM Comment 
#89); Consumer Action (SNPRM Comment #101).
    \221\ Americans for Tax Reform (SNPRM Comment #72). As noted in 
the SNPRM, the Commission does not have empirical data about 
prescriber compliance with the state signage requirement, 16 CCR 
1566, which has been in effect in California since 1994. However, an 
analysis of consumer survey evidence provided by Survey Sampling 
International indicates that regardless of signage, Californians do 
not automatically receive their prescriptions in substantially 
greater numbers than residents of states without a signage 
requirement. SNPRM, 84 FR at 24679.
    \222\ Kochik (SNPRM Comment #8) (stating that the real issue is 
that patients are unaware of the law, and so the solution is 
signage); Letter from 20 U.S. Senators (SNPRM Comment #38); Letter 
from Sen. Lisa Murkowski (SNPRM Comment #49).
    \223\ American Optometric Association (SNPRM Comment #96). The 
obligation in question is the HIPAA requirement that health care 
providers provide patients with a Notice of Privacy Practices 
(``NPP'') and obtain a patient's signature acknowledging receipt of 
same. Notice of Privacy Practices for Protected Health Information, 
14 CFR 164.520(c)(2)(ii).
    \224\ American Optometric Association (SNPRM Comment #96) 
(quoting Request for Information on Modifying HIPAA Rules to Improve 
Coordinated Care, 83 FR 64302, 64302-03 (2018), https://www.govinfo.gov/content/pkg/FR-2018-12-14/pdf/2018-27162.pdf#page=1.)
    \225\ American Optometric Association (SNPRM Comment #96). It is 
worth noting that a review of the comments submitted in response to 
the recent HHS proposal to eliminate HIPAA's signed-acknowledgment 
requirement reveals that while many health care providers do 
consider it an unnecessary use of staff time and resources, other 
health care providers support the acknowledgment requirement, and 
several noted that the burden of obtaining a patient's signed 
acknowledgment is relatively minimal. See, e.g., Jackson Health 
System (Comment in Response to Request For Information, Office for 
Civil Rights, Department of Health and Human Services [hereinafter 
``HHS RFI Comment''] #467) (does not support modifying the 
requirement because signed NPP acknowledgment forms are ``useful'' 
to prove that the NPP was provided to the patient); Dr. Mitchell 
Strauss (HHS RFI Comment #851) (``The signature is the only way of 
confirming for posterity that the NPP was discussed. If this step is 
no longer required, it will be far too easy for practices to stop 
making the effort for acknowledgement of the NPP.''); Multnomah and 
Clackmas Counties (HHS RFI Comment #926) (foresees adverse 
consequences--potential complaints and misunderstandings--if signed 
acknowledgment requirement is removed); San Francisco Department of 
Public Health (HHS RFI Comment #1241) (``Having a written record 
assures patients and covered entities that patients are informed 
about privacy practices.''); American College of Osteopathic Family 
Physicians (HHS RFI Comment #1262) (strongly believes that there 
must be some level of accountability and responsibility for ensuring 
patients understand their privacy rights); Massachusetts Department 
of Mental Health (HHS RFI Comment #1003) (``The burden is 
negligible.''); Missouri Hospital Association (HHS RFI Comment 
#1175) (``MHA's members do not find the requirement cumbersome.''); 
Cigna (HHS RFI Comment #1132) (``Obtaining acknowledgment of receipt 
is not an operational burden [and] the burden to maintain document 
of acknowledgment or declination is minimal.''). HHS RFI Comments 
are available at https://www.regulations.gov/docketBrowser?rpp=25&po=0&D=HHS-OCR-2018-0028.
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    While it is true that HHS is presently evaluating whether to 
eliminate the HIPAA Notice of Privacy Practices signed-acknowledgment 
requirement, the Commission's Confirmation of Prescription Release 
proposal, and the decision not to allow signage as an alternative, does 
not rely on the HIPAA signed-acknowledgment requirement as precedent. 
In the SNPRM, the Commission merely referenced aspects of HIPAA's 
signed-acknowledgment requirement and HHS's evaluation of the 
regulatory burden as informative when considering whether to require 
some form of patient confirmation of

[[Page 50685]]

prescription release.\226\ Any other reliance on the HIPAA signed-
acknowledgment requirement is generally inappropriate since that 
signed-acknowledgment requirement differs from the Commission's 
confirmation proposal in important respects. The primary intent of the 
HIPAA signed-acknowledgment was to provide patients an opportunity to 
review the provider's Notice of Privacy Practices, discuss concerns 
related to their private health information, and request additional 
confidentiality.\227\ It was not to remedy a lack of compliance by 
doctors with HIPAA requirements. Unlike this Rule review, the HHS 
record does not contain empirical evidence showing that doctors are not 
fulfilling their obligations to provide Notices of Privacy Practices to 
patients, and only a handful of commenters to HHS's recent Request for 
Information even suggested that this could occur should the HIPAA 
signed acknowledgment be removed.\228\ This contrasts sharply with the 
circumstances of the Commission's proposed Confirmation of Prescription 
Release, which is intended to remedy a documented compliance gap 
resulting, at least to some extent, from inherent incentives that may 
discourage prescribers from providing patients with their 
prescriptions.
---------------------------------------------------------------------------

    \226\ SNPRM, 84 FR at 24682.
    \227\ Request for Information on Modifying HIPAA Rules to 
Improve Coordinated Care, Office for Civil Rights, Department of 
Health and Human Services, 83 FR at 64308.
    \228\ See generally Comments in Response to Request for 
Information on Modifying HIPAA Rules to Improve Coordinated Care, 
Office for Civil Rights, Department of Health and Human Services, 
https://www.regulations.gov/docketBrowser?rpp=25&po=0&D=HHS-OCR-2018-0028.
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    The Commission continues to believe that for purposes of automatic 
prescription release, signage would be significantly less effective 
than the proposed Confirmation of Prescription Release. None of the 
comments to the SNPRM presented any data or evidence that would counter 
the Commission's prior conclusion. The AOA's argument that the HIPAA 
signed-acknowledgment experience should not be looked to as a model 
does not alter the Commission's determination that there is a 
compelling need for a verifiable method of ensuring that contact lens 
patients receive their prescriptions.
b. Educational Programs as an Alternative to Confirmation of 
Prescription Release
    Some commenters opined that instead of having consumers confirm 
that they received their prescription, the best manner to inform 
consumers about their prescription rights was through an educational 
program.\229\ According to one contact lens manufacturer, the FTC and 
sellers should continue to ``communicate to patients through social 
media, websites, advertising, and other channels so that patients 
become even more aware that they can leave their final fitting with a 
copy of their right prescription.'' \230\ Others suggested that the 
Commission could partner with the Centers for Disease Control and the 
Food and Drug Administration (``FDA'') to produce public service 
announcements informing patients of their rights.\231\ Another 
commenter suggested that instead of a signed confirmation, patients' 
rights to their prescriptions could be ``spelled out in the entry forms 
a patient signs when they check in.'' \232\ Similarly, the AOA 
suggested that a ``patient bill of rights for contact lens wearers'' 
could be provided to patients that would include FDA information on 
considerations for buying lenses.\233\ One commenter, the NAOO, said 
that even with a Confirmation of Prescription Release, the Commission 
should focus on educating the public about its rights to automatic 
release of a prescription.\234\
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    \229\ Abert (SNPRM Comment #20); Tran (SNPRM Comment #94); 
CooperVision, Inc. (SNPRM Comment #130).
    \230\ CooperVision, Inc. (SNPRM Comment #130).
    \231\ American Optometric Association (SNPRM Comment #96); Tran 
(SNPRM Comment #94).
    \232\ Cutter (SNPRM Comment #81).
    \233\ American Optometric Association (SNPRM Comment #96).
    \234\ National Association of Optometrists and Opticians (SNPRM 
Comment #129).
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    The Commission agrees that educating the public can aid in 
increasing the likelihood that contact lens users will receive their 
prescriptions after a fitting.\235\ Consumer education in itself, 
however, whether provided via information entry forms, a patients' bill 
of rights, advertising, or public service announcements, would not have 
a significant impact on prescriber compliance with automatic 
prescription release, and would not increase the Commission's ability 
to monitor and enforce the Rule. The proposed education alternatives 
would also place a burden on consumers to enforce their own rights, an 
approach the Commission has rejected repeatedly in the past when 
considering whether to amend the Contact Lens Rule and Eyeglass Rule to 
release-upon-request.\236\ Therefore, while the Commission believes 
education about the Rule and its automatic-prescription-release 
provision is important, the Commission does not believe education 
should be the sole means of improving Rule compliance.
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    \235\ The Commission educates consumers on their rights under 
the Contact Lens Rule through a variety of sources, including blog 
posts, Facebook, Twitter, and on the FTC's website. See, e.g., 
https://www.consumer.ftc.gov/articles/0116-prescription-glasses-and-contact-lenses.
    \236\ See Eyeglass I, 43 FR at 23998 (stating that relying upon 
release-upon-request is problematic because many consumers are 
unaware of their right to a prescription, and because the right 
should be ``immunized from an evidentiary squabble over whether the 
consumer actually did or did not request the prescription''); Final 
Trade Regulation Rule, Ophthalmic Practice Rules 54 FR 10285, 10286-
87 (Mar. 13, 1989) [hereinafter Eyeglass II] (rejecting a proposal 
to change the Rule to release-upon-request and finding a 
``continuing need'' for automatic release). See also Contact Lens 
Rule, 69 FR at 40492 (discussing a commenter proposal to allow 
prescribers to not release the prescription or release it for 
``informational purposes only'' if the patient has purchased a full 
year's supply of contact lenses at the time of the examination, and 
rejecting it because ``such an exception would be contrary to the 
Act's express requirement that consumers receive a copy of their 
prescription at the completion of a contact lens fitting'').
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7. Comments About the Burden and Benefits of the Confirmation of 
Prescription Release Proposal
    Many commenters stated that even with the proposed modifications to 
increase flexibility, the Confirmation of Prescription Release 
requirement is still overly burdensome for prescribers.\237\ According 
to commenters, eye care practitioners are already overburdened by 
regulatory requirements, and the confirmation requirement would divert 
resources from patient care, increase health care costs, and might even 
drive some prescribers to cease prescribing contact lenses or close 
their practices.\238\ More specifically, the AAO stated that many of 
the options for obtaining patient confirmation would require practices 
to change procedures and alter administrative forms.\239\ Others noted

[[Page 50686]]

that the requirement to dispense paper copies of the confirmation to 
patients runs counter to the trend towards electronic records, 
particularly for those who have already invested in an electronic 
recordkeeping system.\240\ One commenter opined that patients ought to 
bear more responsibility for their own health care.\241\ Others noted 
that the proposal was ``going against the tide'' by adding a new 
regulation at a time when some government agencies are looking to 
reduce regulations.\242\
---------------------------------------------------------------------------

    \237\ Warner (SNPRM Comment #9); Mass Mail Campaign (SNPRM 
Comment #25) (saying the requirement imposed ``massive new costs and 
far-reaching new requirements on all contact lens prescribing''); 
Yokum (SNPRM Comment #53); Staup (SNPRM Comment #104); American 
Society of Cataract and Refractive Surgery (SNPRM Comment #127); 
Letter from Sen. Lisa Murkowski (SNPRM Comment #49).
    \238\ Goldstein (SNPRM Comment #14) (``The economic burdens of 
administrative compliance with these new regulations would except in 
rare cases encourage me not to fit or prescribe contact lenses.''); 
Pierce (SNPRM Comment #17) (will ultimately lead to higher health 
care costs, might have to raise fees); Mass Mail Campaign (SNPRM 
Comment #25); Shum (SNPRM Comment #80) (``Adding more paperwork and 
scanning work--and making it required on everyone--doesn't sound 
like it would be a big deal, but to a small practice it's huge.''); 
Cinalli (SNPRM Comment #93) (new regulation will close many 
practices); Klepfisz (SNPRM Comment #140) (burden has the potential 
to put some prescribers out of business).
    \239\ American Academy of Ophthalmology (SNPRM Comment #136).
    \240\ Lowe (SNPRM Comment #40); Reeder (SNPRM Comment #55) 
(signature upon receipt of prescription is ``burdensome and counter 
to other initiatives to reduce paper held by offices''); Boyer 
(SNPRM Comment #59) (``We try very hard to reduce paper waste . . . 
. [This] will undo our efficiency and distract our staff from our 
daily caseload, resulting in increased costs and reduced care.'').
    \241\ Steiner (SNPRM Comment #7).
    \242\ American Optometric Association (SNPRM Comment #96); 
American Society of Cataract and Refractive Surgery (SNPRM Comment 
#127).
---------------------------------------------------------------------------

    Some commenters believed the Commission was underestimating the 
burden to obtain confirmations and preserve the records, and provided 
their own estimates, including that it would cost $10,000 per 
year,\243\ or would require 10 minutes per patient for a total of ``850 
man-hours per year,'' \244\ the equivalent of about 21 additional weeks 
of work. The AOA, which had previously estimated the cost of the 
signed-acknowledgment requirement to be as high as $18,795 per 
optometrist,\245\ did not submit a new burden estimate for the 
Confirmation of Prescription Release proposal, but reiterated its 
belief that the Rule's burden falls disproportionately on prescribers, 
and expressed concern that the estimated financial burden for the Rule 
in the 2019 SNPRM is higher than the financial burden estimate cited 
for the NPRM's signed-acknowledgment proposal.\246\ Some commenters 
also stated that the use of option (D), electronic delivery, would not 
significantly reduce their burden, since it would require them to 
update their systems or invest in expensive technology.\247\ According 
to the AOA, many prescribers would not be able to opt for electronic 
delivery because of limitations in electronic health records systems, 
privacy and data-security concerns, and state regulations that might 
not permit prescription posting to portals.\248\
---------------------------------------------------------------------------

    \243\ Pierce (SNPRM Comment #17).
    \244\ Steinemann (SNPRM Comment #65).
    \245\ American Optometric Association (NPRM Comment #3830). This 
estimate was cited again by some commenters to the SNPRM. Koerber 
(SNPRM Comment #41); American Society of Cataract and Refractive 
Surgery (SNPRM Comment #127). In the SNPRM, the Commission explained 
that it could not accord this estimate significant weight because it 
was based not on the cost of the Commission's proposed Signed 
Acknowledgment but on the overall cost of government regulations 
(including those already in place), and because the survey had 
various methodological limitations. SNPRM, 84 FR at 24677.
    \246\ American Optometric Association (SNPRM Comment #96).
    \247\ American Society of Cataract and Refractive Surgery (SNPRM 
Comment #127).
    \248\ American Optometric Association (SNPRM Comment #96).
---------------------------------------------------------------------------

    Other commenters disputed that the burden would be significant, and 
stated that the confirmation requirement would not add significant 
costs or time.\249\ According to the Information Technology & 
Innovation Foundation, prescriber claims that the proposal would 
require significant additional staff training are overstated.\250\ 
Another commenter, a prescriber, stated, ``In our office, we already 
have patients sign a contact lens agreement before the contact lens 
evaluation process. I don't see a problem adding a document at the end 
of the process and having the patient sign an acknowledgment of rx 
receipt.'' \251\ One commenter contended that while there would be some 
burden on eye care providers, it represented just a ``tiny fraction'' 
of the industry's overall revenue, and would be far outweighed by the 
benefits.\252\ Others asserted that allowing prescribers to provide 
patients with digital copies would save both prescribers and patients 
time and money.\253\ Some commenters suggested that the Commission was 
actually over-estimating the burden imposed by the confirmation 
requirement.\254\ 1-800 CONTACTS, for example, submitted a new analysis 
from Stanford University Professor Laurence Baker, which called the 
assumptions used in the Commission's burden analysis very 
``conservative,'' and estimated that a reduction in verifications by 
just 15% would be sufficient to offset all of the costs of the 
confirmation requirement.\255\ The NAOO also felt the burden would be 
``minimal,'' and opined that with more patients in possession of their 
prescriptions, there would be fewer orders relying on the verification 
process, and thus fewer verifications for prescribers to have to take 
the time to respond to.\256\ NAOO also opined that with more 
practitioners moving to practice management systems and electronic 
health records, digital delivery of contact lens prescriptions is a 
``very feasible'' option for many prescribers, which would reduce the 
burden of the confirmation requirement.\257\
---------------------------------------------------------------------------

    \249\ Tobias (SNPRM Comment #45); Rawson (SNPRM Comment #68); 
(Citizen Outreach (SNPRM Comment #78); Consumer Action (SNPRM 
Comment #101); Information Technology and Innovation Foundation 
(SNPRM Comment #103); National Association of Optometrists and 
Opticians (SNPRM Comment #129); Consumer Reports (SNPRM Comment 
#133).
    \250\ Information Technology and Innovation Foundation (SNPRM 
Comment #103) (``A few minutes of instruction, coupled with reading 
a one- or two-page memo should more than suffice.'').
    \251\ Gilberg (SNPRM Comment #46).
    \252\ Taxpayer Protection Alliance (SNPRM Comment #118) (overall 
burden of the new requirement would be minimal and outweighed by the 
substantial benefit of having significantly more patients in 
possession of their prescription).
    \253\ Grimm (SNPRM Comment #36) (proposal to allow new methods 
for providing prescriptions will help relieve paperwork burden); 
Coalition for Contact Lens Consumer Choice (SNPRM Comment #78); Liao 
(SNPRM Comment #2) (portal proposal will make automatic release more 
efficient).
    \254\ National Taxpayers Union (SNPRM Comment #149); 1-800 
CONTACTS (SNPRM Comment #135, Ex. A).
    \255\ 1-800 CONTACTS (SNPRM Comment #135).
    \256\ National Association of Optometrists and Opticians (SNPRM 
Comment #129).
    \257\ Id.
---------------------------------------------------------------------------

    Some commenters also felt that the Commission should not give much 
weight to burden concerns raised by prescribers due to their history of 
not complying with their prescription-release obligations.\258\ The 
National Hispanic Medical Association, for example, stated that the 
focus on the burden for prescribers was ``upsetting when one remembers 
just how many patients are being robbed of their right to lower prices 
and more convenient shipping and being denied a copy of something that 
they worked hard to pay for, namely, their own prescription.'' \259\
---------------------------------------------------------------------------

    \258\ Information Technology & Innovation Foundation (SNPRM 
Comment #103); 1-800 CONTACTS (SNPRM Comment #135); National 
Hispanic Medical Association (SNPRM Comment #146).
    \259\ National Hispanic Medical Association (SNPRM Comment 
#146).
---------------------------------------------------------------------------

    The Commission has considered the burden the Confirmation of 
Prescription Release requirement would place on prescribers. As stated 
in the SNPRM, the evidentiary record does not establish that the burden 
will be substantial.\260\ Nothing received or revealed since the SNPRM 
alters that assessment. In fact, numerous health care providers--
commenting on their experience with HIPAA--said that the burden of 
requiring that a patient sign a confirmation-type receipt is 
``minimal,'' \261\ ``negligible,'' \262\ or ``not significant.'' \263\ 
And while AOA is

[[Page 50687]]

correct that the SNPRM's estimated financial burden for the 
Confirmation of Prescription Release was higher than that estimated for 
the Signed Acknowledgment, that was primarily due to an increase in the 
average hourly wages for prescribers and staff.\264\ In terms of time 
required for prescribers and their staff to comply, the SNPRM burden 
from the confirmation proposal was 13% less than that of the NPRM's 
signed-acknowledgment proposal.\265\ The estimated burden of this 
modified Final Rule is also higher than the Signed Acknowledgment 
proposal, but a large part of the increase is due to higher wages and a 
substantial rise in the number of estimated contact lens wearers since 
publication of the NPRM.\266\ Furthermore, while the Final Rule's 
estimated financial burden for the Confirmation of Prescription Release 
requirement of $20,428,750, is not insignificant, it amounts to 
approximately just $342 in increased administrative costs per eye care 
provider.\267\ In addition, while not every prescriber will be able to 
use option (D) to deliver a prescription electronically, the Commission 
is confident that this option will still reduce the burden for many, 
especially as more prescribers move toward electronic recordkeeping.
---------------------------------------------------------------------------

    \260\ SNPRM, 84 FR at 24681.
    \261\ Multnomah and Clackamas Counties (HHS RFI Comment #926); 
Cigna (HHS RFI Comment #1132).
    \262\ Massachusetts Department of Mental Health (HHS RFI Comment 
#1003).
    \263\ San Francisco Department of Public Health (HHS RFI Comment 
#1238). See also Jackson Health System (HHS RFI Comment #467) (``The 
acknowledgment procedure takes less than one minute.''); UnityPoint 
Health (HHS RFI Comment #1122) (costs are relatively low, average of 
60 seconds to explain NPP and obtain patient's signature); UC Health 
(HHS RFI Comment #1155) (time spent to explain and obtain each 
signed acknowledgment is 40 seconds per patient); Missouri Hospital 
Association (HHS RFI Comment #1175); American Alliance of 
Orthopaedic Executives (HHS RFI Comment #1183). Other commenters to 
the HHS proposal disagreed, stating that the NPP signed 
acknowledgment requirement was an unnecessary burden, although much 
of their criticism was directed at the NPP itself rather than the 
acknowledgment. See, e.g., American Physical Therapy Association 
(HHS RFI Comment #601) (``Providers currently undertake reasonable 
efforts to obtain the patient's signature, and in most instances the 
patients ignore the language when signing the document.''); Highmark 
Health (HHS RFI Comment #1124) (``The effort to comply with this 
requirement is disproportionately onerous vis-[agrave]-vis the 
general lack of attention individuals afford the NPP.'').
    \264\ SNPRM, 84 FR at 24693-94.
    \265\ SNPRM, 84 FR at 24693-94.
    \266\ See Section XI, infra.
    \267\ This is based on an estimate from Wallace Lovejoy, a 
consultant for the National Association of Optometrists and 
Opticians, that there are approximately 43,000 optometrists and 
16,700 ophthalmologists in the U.S. CLR Panel I Tr., supra note 100, 
at 6. Estimates vary as to the total number of eye care providers 
and contact lens prescribers in the United States, making it 
difficult to precisely calculate the burden on a per-provider or 
per-prescriber basis. The investment firm Harris Williams & Co., for 
instance, put the estimate at 46,000 optometrists and 18,000 
ophthalmologists. Harris Williams & Co., Vision Industry Update, at 
2 (Mar. 2017) https://www.harriswilliams.com/system/files/industry_update/vision_industry_update_hcls_0.pdf. Meanwhile, the 
U.S. Bureau of Labor Statistics estimates there are 42,100 
optometrists in the U.S., but does not provide an estimate for the 
number of ophthalmologists. https://www.bls.gov/ooh/healthcare/optometrists.htm#tab-1. It must be noted, however, that not all 
optometrists and ophthalmologists prescribe contact lenses.
---------------------------------------------------------------------------

8. Comments About the Exemption for Prescribers Who Do Not Have a 
Direct or Indirect Financial Interest in the Sale of Contact Lenses
    In the SNPRM, the Commission proposed an exemption from the 
Confirmation of Prescription Release requirement for prescribers who do 
not have a direct or indirect financial interest in the sale of contact 
lenses, including, but not limited to, though an association, 
affiliation, or co-location with a contact lens seller.\268\ The 
purpose of the proposed exemption was to reduce the burden on 
prescribers who do not sell lenses, and therefore, have no incentive to 
withhold prescriptions. The failure of the prescriber to provide the 
prescription under such circumstances would provide no benefit to the 
prescriber while likely alienating the patient. In fact, there is a 
strong incentive to provide patients with their prescriptions, since 
that is the only way they would be able to obtain contact lenses.
---------------------------------------------------------------------------

    \268\ SNPRM, 84 FR at 24698.
---------------------------------------------------------------------------

    At least one commenter voiced support for the exemption,\269\ but 
some were critical of the proposal.\270\ Some commenters suggested 
removing it in order to ``future proof'' the prescription-release 
process in light of new and evolving business models--and intermingled 
financial interests--between prescribers and contact lens sellers.\271\ 
According to one commenter, the exception for those without a financial 
interest is ``intentionally vague and leaves the barn door open for 
interpretation and abuse.'' \272\ The AOA also objected to the 
underlying premise that prescribers might consider their own interests 
above those of their patients.\273\
---------------------------------------------------------------------------

    \269\ Consumer Reports (SNPRM Comment #133) (``Although getting 
and keeping a record of the patient confirmation will not pose any 
significant burden, by definition these prescribers would seem not 
to pose any risk of conflict of interest in releasing the 
prescription; indeed, they would have an inherent interest in 
releasing it.'').
    \270\ Contact Lens Institute (SNPRM Comment #79); Zerbinopoulos 
(SNPRM Comment #147); Johnson & Johnson Vision Care, Inc. (SNPRM 
Comment #151).
    \271\ See Contact Lens Institute (SNPRM Comment #79); Johnson & 
Johnson Vision Care, Inc. (SNPRM Comment #151); Alcon (SNPRM Comment 
#117).
    \272\ Zerbinopoulos (SNPRM Comment #147).
    \273\ American Optometric Association (SNPRM Comment #96).
---------------------------------------------------------------------------

    The Commission recognizes these concerns, but believes there is a 
significant benefit in more narrowly targeting only those with an 
incentive to withhold prescriptions, thereby further reducing the 
overall burden and avoiding unnecessarily impacting prescribers who are 
unlikely to violate the Rule. Moreover, the Commission believes that 
determination of whether a financial interest exists is feasible, and 
that prescribers are unlikely to arrange their financial interests and 
business structures solely to circumvent the Confirmation of 
Prescription Release requirement. The Commission also believes it has 
the investigative tools to examine whether there is a financial 
interest, should the need arise. And if the Commission determines upon 
later review that such financial manipulation is occurring to 
circumvent the Rule, the Commission can revisit whether to remove the 
exemption.

D. Additional Discussion and Commission Determination Regarding the 
Confirmation of Prescription Release Proposal

    The Commission has carefully reviewed and analyzed the entire 
record developed with respect to the Confirmation of Prescription 
Release proposal. This record includes more than 8,000 comments 
submitted in response to its 2015 Request for Comment, 2016 NPRM, 2018 
Contact Lens Workshop, and 2019 SNPRM, as well the original history and 
legislative record relating to enactment of the FCLCA and the Rule in 
2004.
    The evidentiary record as set forth in the NPRM and the SNPRM, as 
well as the Commission's enforcement and oversight experience, supports 
the view that compliance with the Rule's automatic-prescription-release 
requirement is sub-optimal, and as a result, a substantial number of 
consumers--several million contact lens users every year--are not 
receiving their contact lens prescriptions as required by law. Many 
consumers are unaware they even have a right to receive them. 
Implementing a Confirmation of Prescription Release requirement will 
result in an increase in the number of patients in possession of their 
prescriptions; improved flexibility and choice for consumers; a reduced 
verification burden for prescribers and sellers; a reduced likelihood 
of medical errors associated with incorrect, invalid, and expired 
prescriptions; and a reduction in the number of attempts to verify with 
the wrong prescriber.\274\ The ultimate result will be improved 
competition in the market, more efficient contact lens sales, improved 
patient safety, and lower prices for consumers. Furthermore, the

[[Page 50688]]

requirement will increase the Commission's ability to enforce and 
assess its Rule, and will accomplish this in a reasonable manner that 
takes into consideration the needs and burdens of prescribers and 
sellers.
---------------------------------------------------------------------------

    \274\ SNPRM, 84 FR at 24681.
---------------------------------------------------------------------------

    In response to commenters' concerns, the Commission has made three 
modifications to the proposal put forth in the SNPRM. The Commission 
concurs with the suggestion that requiring prescribers to identify the 
specific method or methods they would use for electronic delivery of 
prescriptions will increase awareness and allow patients to make a more 
informed decision. The Commission will therefore define ``Provide to 
the patient a copy'' in the Final Rule to require that prescribers who 
choose to offer an electronic method of delivery identify the specific 
method or methods used. The Commission also believes that evidence of 
consumer consent to electronic delivery of a prescription will aid in 
enforcing the Rule, and thus in its Final Rule, the Commission is 
requiring that prescribers keep records or evidence of a patient's 
affirmative consent to a digital copy for at least three years. Lastly, 
for instances where a consumer refuses to sign the confirmation, in the 
Final Rule, the Commission directs the prescriber to note the refusal 
and preserve this record as evidence of compliance. The Commission 
believes that the burden from these three changes will be minimal.

III. Additional Requirements for Sellers Using Verification Calls 
Containing Automated Messages

    In response to the Commission's NPRM, a number of commenters 
criticized the use of verification calls containing automated messages 
(``automated telephone messages''), which they often refer to as 
``robocalls,'' \275\ with some requesting an outright ban of these 
calls.\276\ The Act and the Rule dictate that sellers that do not have 
a contact lens prescription presented to them directly or by facsimile 
verify the prescription by ``direct communication.'' \277\ That term, 
in the Act and Rule, is defined as ``completed communication by 
telephone, facsimile, or electronic mail.'' \278\ The Commission has 
stated that the Act expressly permits telephone communication for 
verification and believes that it would be contrary to congressional 
intent to prohibit use of automated telephone calls for the purpose of 
prescription verification.\279\
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    \275\ See SNPRM, 16 FR at 24684 and n.270.
    \276\ See SNPRM, 16 FR at 24685 and n.281.
    \277\ 15 U.S.C. 7603(a); 16 CFR 315.5(a)(2).
    \278\ Specifically, the Act defines direct communication to 
``include'' a completed communication via one of these three 
methods, 15 U.S.C. 7603(g), whereas the Rule defines ``direct 
communication'' to ``mean'' a completed communication via one of 
these three methods, 16 CFR 315.2, a distinction discussed below.
    \279\ SNPRM, 16 FR at 24684.
---------------------------------------------------------------------------

    In response to the SNPRM, commenters continued to express criticism 
of automated telephone messages \280\ with some continuing to urge the 
Commission to ban them.\281\ The AOA indicated that issues surrounding 
automated telephone messages have increased in the past five years and 
that poor quality automated telephone messages are jeopardizing eye 
health and resulting in consumers wearing non-prescribed contact 
lenses. It reports an increase in the use of calls that are difficult 
to understand, do not include all of the necessary information to 
confirm the prescription, and create barriers for prescribers to 
communicate corrections.\282\ Johnson & Johnson Vision Care and 
individual prescribers believe that automated telephone messages can 
ultimately lead to patients receiving incorrect lenses and suffering 
adverse health outcomes.\283\
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    \280\ Gilberg (SNPRM Comment #46); Armitage (SNPRM Comment #66); 
Contact Lens Institute (SNPRM Comment #79); American Optometric 
Association (SNPRM Comment #96); Health Care Alliance for Patient 
Safety (SNPRM Comment #128); CooperVision, Inc. (SNPRM Comment 
#130); Johnson & Johnson Vision Care, Inc. (SNPRM Comment #151).
    \281\ Gilberg (SNPRM Comment #46); Armitage (SNPRM Comment #66); 
Contact Lens Institute (SNPRM Comment #79); Health Care Alliance for 
Patient Safety (SNPRM Comment #128); CooperVision, Inc. (SNPRM 
Comment #130); Johnson & Johnson Vision Care, Inc. (SNPRM Comment 
#151).
    \282\ American Optometric Association (SNPRM Comment #96).
    \283\ Reeder (SNPRM Comment #55) (automated calls and passive 
verification can result in approval for patients who have never been 
seen and can lead to injury); Armitage (SNPRM Comment #66) (no way 
to safely and accurately ensure that a patient's prescription is 
correctly verified with a robocall-based system); Johnson & Johnson 
Vision Care, Inc. (SNPRM Comment #151). See also Alcon Vision, LLC 
(SNPRM Comment #117) (noting health and safety risks associated with 
robocalls).
---------------------------------------------------------------------------

    Other commenters, however, indicated that automated telephone 
messages were not problematic and should not be prohibited.\284\ 
Consumer Action stated that ``automated call systems appear to be 
working in a majority of cases'' and that prescribers should design 
more responsive systems for handling such requests.\285\ The NAOO 
commented that from its members' perspective, there are ``no issues 
with the use of automated calls, which tend to be infrequent to any 
particular prescriber's office'' and that such calls are an efficient 
method of verification.\286\
---------------------------------------------------------------------------

    \284\ Consumer Action (SNPRM Comment #101); National Association 
of Optometrists and Opticians (SNPRM Comment #129).
    \285\ Consumer Action (SNPRM Comment #101).
    \286\ National Association of Optometrists and Opticians (SNPRM 
Comment #129); see also 1-800 CONTACTS (SNPRM Comment #135) (its 
records indicate that ``on average, prescribers are asked to verify 
just one order from 1-800 a week'').
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A. The Congressional Record Does Not Support Prohibiting Automated 
Telephone Messages

    Commenters in favor of a ban on such calls argue that the 
Commission lacks evidence that Congress intended to include automated 
calls in the definition of ``direct communication'' \287\ and should 
eliminate the use of this antiquated technology in favor of methods 
that provide written documentation and the possibility of greater 
oversight in the verification process.\288\ In support of a ban, 
commenters stated that the Act does not mention the use of automated 
telephone messages and that the Commission's interpretation of such 
calls as a valid form of ``direct communication'' may be counter to 
testimony provided during hearings that occurred prior to the Act's 
implementation.\289\ These commenters stated that ``congressional 
members and the then CEO of a major online contact lens seller made 
statements critical of automated telephone verification, stating 
explicitly that fax or another verifiable method were the preferred 
prescription verification methods for contact lens prescriptions.'' 
\290\
---------------------------------------------------------------------------

    \287\ Health Care Alliance for Patient Safety (SNPRM Comment 
#128); CooperVision, Inc. (SNPRM Comment #130); Johnson & Johnson 
Vision Care, Inc. (SNPRM Comment #151).
    \288\ Health Care Alliance for Patient Safety (SNPRM Comment 
#128); CooperVision, Inc. (SNPRM Comment #130); Johnson & Johnson 
Vision Care, Inc. (SNPRM Comment #151). CLR Panel IV Tr., supra note 
121, at 9 (request of Steinemann for written requests only and not 
``robocalls'').
    \289\ Health Care Alliance for Patient Safety (SNPRM Comment 
#128); Johnson & Johnson Vision Care, Inc. (SNPRM Comment #151).
    \290\ Health Care Alliance for Patient Safety (SNPRM Comment 
#128); Johnson & Johnson Vision Care, Inc. (SNPRM Comment #151).
---------------------------------------------------------------------------

    A closer analysis of the congressional testimony reveals a question 
to the CEO of the contact lens seller about earlier testimony by the 
AOA mentioning problems with both automated calls and continuous 
faxes.\291\ The CEO's

[[Page 50689]]

response merely recognized that there had been criticism of automated 
calls, and stated that at that time the company preferred fax 
verifications because they were written.\292\ There is no other mention 
of issues with automated calls by congressional members or the CEO 
during that hearing.\293\ Instead, such testimony arguably shows that 
Congress had been made aware of the criticisms of automated calls and, 
if it had wished to do so, could have banned their use explicitly. Yet, 
Congress specifically included telephone as a valid form of direct 
communication. The hearing also evidences a recognition that telephone 
communications, unlike faxes, would not be written. As a result, 
reference to this testimony does not change the Commission's view that 
automated telephone messages are a permissible form of direct 
communication.
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    \291\ See ``Fairness to Contact Lens Consumers Act: Hearing 
Before the Subcommittee on Commerce, Trade, and Consumer Protection 
of the House Committee on Energy and Commerce,'' 108th Cong. 1 
(Sept. 12, 2003) (Rep. Shimkus: ``Mr. Coon [CEO of 1-800 CONTACTS], 
there have been some questions [raised in earlier hearing testimony 
from the AOA] about the techniques companies like yours use to 
verify orders for contact lens prescriptions, and problems such as 
automated calls and continuous faxes inhibiting optometrists from 
verifying prescriptions. Could you just go through your procedures 
for me?'').
    \292\ Id. (In response to Rep. Shimkus's request to go through 
the company's procedures, Rep. Burr: Mr. Coon, how does 1-800 
currently request doctor verification? Mr. Coon: Well, the best 
system that we have found works the best, which we do in a majority 
of our orders--and there has been criticism of phone automated 
systems and other things. The system that works the best is in 
writing by fax. We know that there is a confirmation that it was 
received. And that's the system that we would recommend.'').
    \293\ The Commission is also unaware of any other on-the-record 
discussions about automated calls during congressional consideration 
of the FCLCA.
---------------------------------------------------------------------------

    The Health Care Alliance for Patient Safety referred to automated 
telephone messages as antiquated technology,\294\ and stated that the 
Commission should ban such calls in favor of methods that provide 
verifiable written communication, including fax, emails, and electronic 
portals.\295\ Such documentation, according to the Alliance, will allow 
for greater oversight and a safer environment allowing prescription 
verification through clearer, more concise and accurate communication 
between the prescriber and the seller.\296\ As previously stated, 
Congress expressly permitted use of the telephone knowing that this 
method did not produce writings like the other delineated verification 
methods, facsimile and email, and thus, the Commission declines to 
prohibit the use of this medium for verification.
---------------------------------------------------------------------------

    \294\ Health Care Alliance for Patient Safety (SNPRM Comment 
#128).
    \295\ Health Care Alliance for Patient Safety (SNPRM Comment 
#128); CooperVision, Inc. (SNPRM Comment #130). The Commission 
declines to include portals as a method by which sellers can verify 
prescriptions. In considering the proposal, the Commission 
considered that the Act defines direct communication to include 
telephone, fax, or email. As stated in the 2004 SBP, Congress's use 
of the term ``includes'' contemplates that additional methods of 
communication could develop that could be used in the verification 
process. 69 FR 40490. However, there is no evidence that prescribers 
and sellers are using, or are likely to use, portals in the 
verification process.
    \296\ Health Care Alliance for Patient Safety (SNPRM Comment 
#128). The Contact Lens Institute criticized the Commission for 
failing to address the fact that the information conveyed in a 
telephonic communication needs to be reduced to a writing by the 
prescriber's office so it can be compared to patient records, a 
process that must in virtually all cases be conducted separately 
from the call itself. SNPRM Comment #79. It follows, according to 
CLI, that written requests are more efficient and effective 
communication tools for both sellers and prescribers.
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B. Comments About, and Adoption of, Requirements Proposed in the SNPRM 
To Improve Quality of Automated Telephone Messages

    In the SNPRM, the Commission recognized that additional 
requirements for automated verification calls were necessary to relieve 
the burden on prescribers and reduce potential health risks to patients 
from incomplete or incomprehensible automated telephone messages. 
Specifically, the Commission noted that prescribers must be able to 
understand automated messages so they can, if necessary, respond to 
sellers to prevent improper sales.\297\ As a result, the Commission 
proposed, via an amendment to Sec.  315.5, requirements for sellers to 
improve verification calls that use, in whole or in part, an automated 
message. For these calls, sellers must: (1) Record the entire call; (2) 
commence the call by identifying it as a request for prescription 
verification; (3) provide the information required by Sec.  315.5(b) in 
a slow and deliberate manner and at a reasonably understandable volume; 
and (4) give the prescriber the option to repeat the information.\298\
---------------------------------------------------------------------------

    \297\ SNPRM, 16 FR at 24685.
    \298\ SNPRM, 16 FR at 24685.
---------------------------------------------------------------------------

    Commenters were largely in favor of the Commission's proposals to: 
(1) Commence the call by identifying it as a request for prescription 
verification; (2) provide the information required by Sec.  315.5(b) in 
a slow and deliberate manner and at a reasonably understandable volume; 
\299\ and (3) give the prescriber the option to repeat this 
information.\300\ Seller 1-800 CONTACTS indicated that its verification 
messages already comply with these proposed requirements, and the NAOO 
indicated that its members have not identified any significant burdens 
in complying with these requirements.\301\ CooperVision indicated that 
these proposals, along with some of the Commission's other proposals, 
helped address some of the more troubling issues with automated 
messages.\302\ On the other hand, the Contact Lens Institute, comprised 
of the major contact lens manufacturers, indicated that the 
Commission's proposed measures demonstrate the impossibility of 
assuring that automated messages provide effective communication of 
required information and a reliable basis for passive 
verification.\303\ For instance, it stated that the Commission's 
requirements to commence the call by identifying it as a request for 
prescription verification and to give prescribers an option to repeat 
assumes that prescribers will have live staff available 24 hours a day 
and will not need to rely on recording devices.\304\
---------------------------------------------------------------------------

    \299\ The Commission notes that these criteria have always been 
part of the Rule, but it has determined that they should be 
expressly set forth in the Rule. See 81 FR 88540 (``A request 
delivered by an automated telephone system does not comply with the 
Rule if it is not delivered in a volume and cadence that a 
reasonable person can understand.'').
    \300\ American Optometric Association (SNPRM Comment #96) 
(stating support for these requirements, but expressing concern they 
are coming too late); National Association of Optometrists & 
Opticians (SNPRM Comment #129); 1-800 CONTACTS (SNPRM Comment #135); 
Johnson & Johnson Vision Care, Inc. (SNPRM Comment #151) (expressing 
approval for these provisions should the Commission not prohibit 
these calls altogether).
    \301\ National Association of Optometrists & Opticians (SNPRM 
Comment #129); 1-800 CONTACTS (SNPRM Comment #135).
    \302\ CooperVision, Inc. (SNPRM Comment #130).
    \303\ Contact Lens Institute (SNPRM Comment #79). Members of the 
Contact Lens Institute are Alcon Vision, Bausch + Lomb, CooperVision 
and Johnson & Johnson Vision Care. The Commission notes that the 
opinions expressed in the CLI's comment do not always conform with 
the opinions of the manufacturers as expressed in their individually 
filed comments.
    \304\ It also described the Commission's requirement to deliver 
the message in a ``slow and deliberate manner'' and at a 
``reasonable volume'' as so vague as to be potentially 
unenforceable. Contact Lens Institute (SNPRM Comment #79. The 
Commission disagrees with this assessment, finding that these 
conditions are met if, upon listening to a call, the required 
information is comprehensible to a reasonable person.
---------------------------------------------------------------------------

    The Commission does not find these criticisms compelling. The 
Commission recommended these proposals with an awareness that sometimes 
prescribers' offices take these calls live and, at other times, the 
calls are left on recording devices. An option to repeat the 
information is helpful if a person answers live. If not, the prescriber 
has the ability to replay the message from the recording device. 
Similarly, commencing the call by identifying it as a request for 
prescription verification should help ensure that the prescriber's 
office is ready to take the relevant information down, both when 
answering live and when playing the message from a recording device. As 
a

[[Page 50690]]

result, the Commission is implementing these amendments in its Final 
Rule.

C. The Commission's Proposal Requiring Sellers To Record Automated 
Telephone Messages

    In the SNPRM, the Commission also requested comments on its 
proposed amendment to Sec.  315.5 to require sellers who verify 
prescriptions through automated telephone verification messages to 
record the entire call.\305\ Some commenters opposed the proposal,\306\ 
while others supported it.\307\ 1-800 CONTACTS opposed the recording 
requirement, stating that it would impose a costly burden on sellers, 
is unnecessary because the Commission lacks evidence of a systematic 
problem with automated calls, and would not facilitate enforcement or 
improve compliance.\308\ This seller also commented that the 
requirement combined with state wiretapping laws may cause sellers to 
switch to other, perhaps less-reliable verification methods.\309\ In 
favor of the proposal, the AOA indicated that the cost of compliance is 
justified given the widespread issues with robocalls that currently 
exist.\310\
---------------------------------------------------------------------------

    \305\ SNPRM, 84 FR at 24685.
    \306\ Contact Lens Institute (SNPRM Comment #79); 1-800 CONTACTS 
(SNPRM Comment #135); Consumer Reports (Comment #133).
    \307\ The Health Care Alliance for Patient Safety (SNPRM Comment 
#128), CooperVision, Inc. (SNPRM Comment #130), and Johnson & 
Johnson Vision Care, Inc. (SNPRM Comment #151), supported the 
recording requirement if the Commission did not ban automated 
telephone messages altogether. See also American Optometric 
Association (SNPRM Comment #96); National Association of 
Optometrists & Opticians (SNPRM Comment #129).
    \308\ 1-800 CONTACTS (SNPRM Comment #135).
    \309\ Id.
    \310\ American Optometric Association (SNPRM Comment #96).
---------------------------------------------------------------------------

    In support of its position that the recording requirement is 
unnecessary, 1-800 CONTACTS pointed to the Commission's statement in 
the SNPRM that it does not have empirical data showing the frequency of 
verification calls that contain incomplete or incomprehensible 
automated messages.\311\ The seller further commented that the number 
of sellers that use this particular technology is likely limited and 
the Commission can much more easily acquire the evidence necessary to 
investigate complaints and bring an enforcement action in appropriate 
circumstances.\312\ It stated that ``the same cost-benefit approach 
that justifies additional recordkeeping for prescription release, 
counsels against additional superfluous and costly regulation and in 
favor of targeted enforcement.'' \313\ Consumer Reports noted that it 
was not aware of noncompliance similar to that of prescribers' failure 
to release prescriptions.\314\
---------------------------------------------------------------------------

    \311\ 1-800 CONTACTS (SNPRM Comment #135).
    \312\ 1-800 CONTACTS stated that the Commission lacked evidence 
about whether problems occur with automated calls of more than a 
limited number of sellers, and if it is a limited number of sellers, 
the Commission should consider education and enforcement efforts 
instead of rule changes. For instance, the Commission could obtain 
the recording itself from prescribers who assert that they have 
received an invalid or incomprehensible verification call. Id. 
Although the Commission could obtain such recordings from 
prescribers, the information would not be complete. Without the 
ability to obtain recordings from the seller, the Commission would 
be unable to assess if the call the seller relied on was compliant, 
was non-compliant (violating the Rule) but an anomaly, or was part 
of a widespread use of problematic calls. Moreover, as to its point 
about the limited number of sellers making these calls, new contact 
lens sellers are routinely entering the market and the Commission 
needs to ensure it can enforce against them if it receives 
complaints.
    \313\ 1-800 CONTACTS (SNPRM Comment #135).
    \314\ Consumer Reports (SNPRM Comment #133).
---------------------------------------------------------------------------

    The Commission lacks empirical data on this issue, as noted in the 
SNPRM.\315\ However, it is undisputed that automated telephone messages 
are a commonly used method of verification. Moreover, these calls 
impose a cost on prescribers, and there are potential health risks to 
patients from incomplete and incomprehensible automated telephone 
requests.\316\ In fact, many commenters have indicated problems with 
the quality of automated telephone messages.\317\ The AOA commented in 
response to the SNPRM that, in its survey of 629 doctors of optometry, 
85% reported that automated calls for prescription verifications have 
increased in the past five years, and 88% indicated that the quality of 
such calls has decreased in the past five years.\318\ These commenters 
have exposed an issue for enforcement: Without a call recording,\319\ 
the Commission cannot reliably assess whether that call was compliant 
and further whether the seller has a pattern of placing non-compliant 
calls (and selling after such calls).
---------------------------------------------------------------------------

    \315\ SNPRM, 84 FR at 24685.
    \316\ Id.
    \317\ NPRM, 81 FR at 88538 nn.152, 154, 155; SNPRM, 84 FR at 
24684 n.270. See also CLR Panel IV Tr., supra note 121, at 8 
(statement of David Cockrell that the office can't understand many 
of the robocalls); id. at 8 (statement of Tim Steinemann that many 
robocalls are unintelligible or cut off).
    \318\ American Optometric Association (SNPRM Comment #96). 
However, because the AOA did not provide the survey itself or the 
data from the survey, the Commission does not rely on it as more 
than anecdotal evidence.
    \319\ The Commission has received numerous comments from 
prescribers indicating that they have received non-compliant 
messages, some of which were left on their answering machines, yet 
has received very few actual recordings of these messages from 
prescribers.
---------------------------------------------------------------------------

    1-800 CONTACTS commented that it is an unnecessary burden for 
sellers to record and retain copies of thousands of identical 
verification calls, the costs of which would exceed the benefits.\320\ 
Consumer Reports shared this sentiment and suggested that it would be 
more reasonable for the Commission to require sellers to retain a 
sample recording of the standard script, leaving blanks for 
prescription and patient details.\321\ The Commission believes that 
seeing a script of information relayed or a sample recording has 
limited utility. A script or a sample recording would not reveal 
whether the required information was transmitted for any particular 
automated telephone message or if, for instance, required information 
was transmitted before a representative or machine answered, after an 
answering machine cut off, when a prescriber's office put the call on 
hold, or over hold music, in which case the call could not be lawfully 
used as a basis for the sale.\322\ Further, a script or sample 
recording would not permit the Commission to assess whether each call 
was delivered in a ``slow and deliberate manner'' and at a ``reasonably 
understandable volume.'' Without knowing this information, the 
Commission would be unable to determine conclusively whether any 
particular verification request was valid. Therefore, the Commission is 
not adopting this recommendation.
---------------------------------------------------------------------------

    \320\ 1-800 CONTACTS (SNPRM Comment #135).
    \321\ Consumer Reports (SNPRM Comment #133).
    \322\ One commenter requested a requirement for online sellers 
to maintain files of recordings of each verification attempt made by 
automated message for a period of no less than three years. Health 
Care Alliance for Patient Safety (SNPRM Comment #128). The 
Commission is only requiring sellers to maintain recordings of 
automated telephone calls that are the basis for the sale, and to 
maintain these recordings for three years. There is no need under 
the Rule for sellers to maintain recordings of unsuccessful 
verification attempts.
---------------------------------------------------------------------------

    1-800 CONTACTS asserted that the requirement to record verification 
calls would not only impose additional regulatory burdens on sellers, 
but also expose sellers to legal risk.\323\ The seller argued that by 
recording telephone communications, sellers might risk violating two-
party consent laws in the states that require all parties on the call 
to consent to recordings.\324\ After

[[Page 50691]]

reviewing the relevant statutes and applicable case law, the Commission 
does not believe sellers risk conducting illegal calls by recording 
them.\325\
---------------------------------------------------------------------------

    \323\ 1-800 CONTACTS (SNPRM Comment #135).
    \324\ Twelve states have such a requirement: California, 
Connecticut, Delaware, Florida, Illinois, Maryland, Massachusetts, 
Montana, Nevada, New Hampshire, Pennsylvania, and Washington. See 
Cal. Penal Code Sec.  632(a), (c) (West 2019); Conn. Gen. Stat. 
Sec.  52-570d(a) (West 2019); Del. Code Ann. tit. 11, Sec.  2402(a), 
(c)(4) (West 2019); Fla. Stat. Ann. Sec.  934.03(1), (3)(d) (West 
2019); 720 Ill. Comp. Stat. Ann. 5/14-2(a) (West 2019); Md. Code. 
Ann., Cts. & Jud. Proc. Sec.  10-402(a), (c)(3) (West 2019); Mass. 
Gen. Laws Ann. ch. 272, Sec.  99(C) (West 2019); Mont. Code Ann. 
Sec.  45-8-213(1)(c), (2)(a)(iii) (West 2019); Nev. Rev. Stat. Ann. 
Sec.  200.620 (West 2019); N.H. Rev. Stat. Ann. Sec.  570-A:2 
(2019); 18 Pa. Stat. and Cons. Stat. Ann. Sec.  5703, 5704(4) (West 
2019); Wash. Rev. Code Ann. Sec.  9.73.030(1), (3) (West 2019). It 
is also possible that Michigan has a two-party consent law, although 
interpretations of the law differ, and the issue has not been firmly 
resolved. See Mich. Comp. Laws Ann. Sec.  750.539c (``Any person . . 
. who willfully uses any device to eavesdrop . . . without the 
consent of all parties thereto . . . is guilty of a felony). Compare 
AFT Mich. v. Project Veritas, 378 F. Supp. 3d 614, 620 (E.D. Mich. 
2019) (finding statute prohibits participants from recording private 
discourse of any other person involved in the conversation unless 
all persons consent); with Sullivan v. Gray, 324 N.W.2d 58, 60 
(Mich. Ct. App. 1982) (finding statute does not require two-party 
consent because it only prohibits eavesdropping, which is defined as 
recording the ``private discourse of others.'' (emphasis added)).
    \325\ Of course, the Commission cannot predict precisely how 
different jurisdictions will apply state laws. However, the 
Commission is unaware of a party ever being held liable for 
violating two-party consent requirements in a situation where the 
call contained a disclosure message at its onset. The Commission 
further notes that jurisdictions take different approaches to 
deciding which state law applies for interstate or multi-state phone 
calls. See, e.g., Ditech Fin. LLC v. Buckles, 401 P.3d 215 (Nev. 
2017). Therefore, when recording calls with prescribers located in 
other states, sellers should abide by the more stringent law that 
applies or obtain the consent of all parties to the communication. 
As the Commission stated in the SNPRM, 84 FR at 24685 n.288, sellers 
are responsible for determining compliance with state law taping 
requirements.
---------------------------------------------------------------------------

    For instance, though the California penal code prohibits 
eavesdropping on or recording confidential communications without two-
party consent, the code excludes from the definition of ``confidential 
communication'' any circumstances ``in which the parties to the 
communication may reasonably expect that the communication may be 
overheard or recorded.'' \326\ The California Supreme Court has 
stressed that Sec.  632 of the California penal code does not preclude 
parties from ever recording conversations, but rather prohibits parties 
from doing so ``secretly'' or ``surreptitiously,'' declaring that a 
business would not violate the state's wiretapping laws if it advised 
parties to a communication of its intent to record the call at the 
outset of the conversation.\327\ Similarly, in Massachusetts, a person 
cannot willfully intercept any wire or oral communication, with 
``interception'' defined in the statute as secretly hearing, secretly 
recording, or aiding another to do so without the parties' 
consent.\328\ The Massachusetts Supreme Court has ruled that a system 
that expressly notifies the parties that the call will be recorded does 
not commit an interception because the system does not record the 
conversation in secrecy.\329\ Thus, in California and Massachusetts, 
sellers who provide a standard notification at the beginning of the 
call, which has become customary in many business communications, are 
unlikely to risk violating state wiretapping laws.
---------------------------------------------------------------------------

    \326\ Cal. Penal Code Sec.  632(a), (c).
    \327\ Kearney v. Salomon Smith Barney, Inc., 137 P.3d 914, 930 
(Cal. 2006); see also Hataishi v. First Am. Home Buyers Prot. Corp., 
168 Cal. Rptr. 3d 262, 271 (Cal. Ct. App. 2014) (stating California 
consumers are accustomed to receiving notice of a business's 
intention to record a call); CS Wang & Assoc. v. Wells Fargo Bank, 
N.A., 305 F. Supp. 3d 864, 885 (N.D. Ill. 2018) (Under the 
California Invasion of Privacy Act, ``the baseline assumption in 
situations where the recorded party does not initiate the call, does 
not have a prior relationship with the caller, and does not receive 
a warning at the outset of the call, is that it is reasonable for a 
party to expect that its conversation is not being recorded.'') 
(emphasis added).
    \328\ See Mass. Gen. Laws Ann. ch. 272, Sec.  99(B)(4), (C)(1).
    \329\ See Commonwealth v. Boyarsky, 897 N.E.2d 574, 579 (Mass. 
2008) (finding ``there was no interception because there was no 
secret recording, and the inquiry is at an end''); see also Marquis 
v. Google, Inc., No. SUCV2011-02808-BLS1, 2014 WL 4180400, at *12 
(Mass. Super. Ct. July 27, 2014) (``The core of the statute is . . . 
the prevention of the secret interception of wire communications . . 
. . In consequence, if a recording is `not made secretly,' it does 
`not constitute an `interception'' and there has been no violation 
of the statute.'').
---------------------------------------------------------------------------

    Moreover, after reviewing the plain language of other state 
statutes requiring two-party consent and case law, the Commission 
concludes that if sellers express their intentions to record the 
conversation at the outset of each call, sellers located in or 
contacting prescribers in two-party consent states will not risk 
violating a state's respective wiretapping law. Announcements at the 
outset of the calls would prevent sellers from committing violations 
because prescribers can either provide or withhold consent. For 
instance, under Florida's and Maryland's statutes,\330\ as long as a 
party has received notice of an intent to record, the notified party 
can expressly or impliedly consent by remaining on the line.\331\ 1-800 
CONTACTS notes that a prescriber could effectively reject a valid 
method of verification--verification by telephone--by declining to give 
consent.\332\ In the event that a prescriber declines to consent to a 
recorded call containing an automated telephone verification message, 
sellers may make verification requests via email, live call, or fax. 
Sellers may also elect to leave automated telephone messages after 
hours on prescribers' answering machines. Such calls would not 
implicate wiretapping laws since the prescriber is not on the 
line.\333\
---------------------------------------------------------------------------

    \330\ Fla. Stat. Ann. Sec.  934.03(2)(d); Md. Code. Ann., Cts. & 
Jud. Proc. Sec.  10-402(a), (c)(3).
    \331\ See Levin v. Red Rock Fin. Servs., LLC, No. 70006, 2017 WL 
519414, at *1 (Nev. Ct. App. Jan. 30, 2017) (agreeing that summary 
judgment applying Nevada and Florida law had been properly granted 
because appellant ``necessarily heard the pre-recorded announcement 
during every phone call . . . and consequently gave implied consent 
to be recorded during each call by continuing with the call'') 
(emphasis added); Briddell v. State, No. 1220, 2016 WL 4698158, at 
*3-4 (Md. Ct. Spec. App. Sept. 7, 2016) (finding plaintiff ``was not 
forced to communicate . . . nor continue with the phone conversation 
after being notified that it would be recorded and monitored'' and 
consented to recording ``by continuing to speak after the [warning] 
messaged [had] played.'') (emphasis added). See also Wash. Rev. Code 
Ann. Sec.  9.73.030(3) (``[C]onsent shall be considered obtained 
whenever one party has announced to all other parties engaged in the 
communication or conversation, in any reasonably effective manner, 
that such communication or conversation is about to be recorded or 
transmitted.'').
    \332\ 1-800 CONTACTS (SNPRM Comment #135).
    \333\ Some prescribers commenting on the Rule have expressed 
concern that verification calls placed during non-business hours 
violate the Rule. See NPRM, 81 FR at 88544 and n.232. Sellers who 
leave compliant verification messages after hours do not violate the 
Rule as long as they wait the required eight business hours before 
selling lenses (assuming there is no communication from the 
prescriber invalidating or approving the message before that time 
period concludes).
---------------------------------------------------------------------------

    Commenters also opined on whether the Commission should extend its 
recording requirement to verification calls that do not involve 
automated messages, i.e., live calls. 1-800 CONTACTS suggested that the 
requirement to record calls including automated messages should apply 
equally to live calls because sellers might otherwise have an incentive 
to outsource live verification calls to inexpensive call centers that 
can ``game the system'' by making it difficult for prescribers to 
understand or respond to live verification requests.\334\ On the other 
hand, the NAOO, without explanation, supported the Commission's 
recording requirement for automated calls as long as the Commission 
does not expand the requirement to apply to live calls.\335\
---------------------------------------------------------------------------

    \334\ 1-800 CONTACTS (SNPRM Comment #135). The seller also 
pointed to the Commission's statement in the SNPRM that it does not 
know that a phone call with an automated message is necessarily less 
reliable than one with a live person. Id. (citing SNPRM, 84 FR at 
24685).
    \335\ National Association of Optometrists and Opticians (SNPRM 
Comment #129).
---------------------------------------------------------------------------

    For several reasons, the Commission declines to compel sellers to 
record live calls. Foremost, during live calls, a prescriber can ask a 
seller to repeat the message or to clarify unintelligible information, 
and can look up a patient's file in real time to verify the

[[Page 50692]]

prescription.\336\ In this setting, a seller is likely to limit any bad 
conduct. While bad actors could speak incoherently, exclude key 
information, or refuse to repeat the message when asked, the Commission 
has not received or seen evidence of such behavior, and the record does 
not reflect any other widespread issue involving the quality of live 
calls. Finally, the Commission considered mass merchandisers that 
verify prescriptions largely or exclusively by calling prescribers to 
obtain verification via a live call when a customer purchases lenses at 
the store. Because these sellers use their phone lines for a multitude 
of purposes unrelated to prescription verification, such as taking 
consumer orders or checking inventory for a consumer, it would be 
difficult to implement a recording system in compliance with this Rule. 
However, should the Commission receive complaints that show an issue 
with sellers' conduct on live calls, the Commission will reassess the 
need to require sellers to record live verification calls.
---------------------------------------------------------------------------

    \336\ CLR Panel IV Tr., supra note 121, at 15 (statement of 
David Cockrell referring to how live calls provide opportunity for 
two-way conversation).
---------------------------------------------------------------------------

D. The Final Rule Does Not Adopt Commenters' Additional Recommendations 
Regarding Automated Telephone Messages

    A number of additional recommendations were suggested by commenters 
regarding calls that contain, in full or in part, automated 
messages.\337\ The Health Care Alliance for Patient Safety and Johnson 
& Johnson Vision Care requested that the FTC review and approve a 
transcript of sellers' automated telephone messages before sellers are 
permitted to use calls containing such messages.\338\ The Contact Lens 
Institute urged the Commission to require sellers to follow a 
``specific script that includes standardized terms, a standardized 
order of presenting the required information, and a standardized 
pace,'' \339\ and to require sellers to document that they only use 
means of transmission that have been tested and shown to result in 
receipt of clear and unambiguous information at the receiving end of 
the call.\340\
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    \337\ The Contact Lens Institute (SNPRM Comment #79), Health 
Care Alliance for Patient Safety (SNPRM Comment #128), and Johnson & 
Johnson Vision Care, Inc. (SNPRM Comment #151) proposed these 
additional requirements in the event that the Commission declined to 
prohibit use of verification via automated telephone messages.
    \338\ Health Care Alliance for Patient Safety (SNPRM Comment 
#128); Johnson & Johnson Vision Care, Inc. (SNPRM Comment #151).
    \339\ Contact Lens Institute (SNPRM Comment #79). Alcon Vision 
made a similar recommendation. See SNPRM Comment #117.
    \340\ Contact Lens Institute (SNPRM Comment #79).
---------------------------------------------------------------------------

    The Commission is not implementing these recommendations. The 
information that sellers need to include to make a valid verification 
request is clearly delineated in Sec.  315.5(b), (d)(2), and (d)(4) of 
the Final Rule.\341\ The Commission does not believe that reviewing and 
approving a transcript would be an effective use of its resources 
because it is the call itself that ultimately determines whether there 
is a valid verification request. Further, while there is some utility 
in providing a script so prescribers receive the information in a 
predictable manner, the Commission is not convinced that there is only 
one effective way for a seller to comply with the Rule, or that this 
requirement is necessary.\342\ The Rule already indicates what 
information needs to be included in the message, and the additional 
requirements the Commission is implementing should make it easier for 
prescribers to obtain the information. Should seller verification 
messages be deficient in providing all the required information, 
prescribers should notify the seller. Moreover, assuming a seller is 
complying with the Rule by recording calls that contain these messages, 
the Commission can ascertain whether the call included all the required 
information (and whether the seller ultimately sold lenses pursuant to 
an invalid verification call). A review of the recording will provide 
better information on compliance than would knowing that the seller 
used a transcript--including an FTC-approved transcript--or a means of 
transmission that the seller has tested and documented as effective.
---------------------------------------------------------------------------

    \341\ Commission review of a script would not reveal whether the 
seller was complying with Section 315.5(d)(3) and (4) of the Final 
Rule (the requirements as to cadence, volume, and the ability to 
repeat the information).
    \342\ Similarly, 1-800 CONTACTS requested a requirement that a 
pre-recorded message be limited to providing only the information 
required under the Rule and not include extraneous information that 
could make the call confusing or more burdensome. SNPRM Comment 
#135. Although the Commission cautions sellers against including 
extraneous information, it has not seen evidence of a widespread use 
of calls including such information and thus is not implementing 
this recommendation.
---------------------------------------------------------------------------

    The Health Care Alliance for Patient Safety and Johnson & Johnson 
Vision Care also requested a requirement that online sellers confirm 
that automated calls are answered by a person at the prescriber's 
office, as opposed to a recording device, before initiating an 
automated message.\343\ In essence, they are asking for a requirement 
that all verification calls be placed during a prescriber's business 
hours, presumably the time when prescribers' phone lines are 
staffed.\344\ These commenters also requested that the Commission 
require online sellers who use automated telephone messages to provide, 
for prescriber's use, a centralized call-back number and have the call-
back number staffed by a person from the seller.\345\ In the same vein, 
CooperVision commented that the Commission should require sellers to 
provide the means for the prescriber to disrupt a verification call 
that uses, in whole or in part, an automated message, in order to 
connect with a person at the seller to provide correct 
information.\346\ Without this requirement, according to CooperVision, 
eye care professionals are limited in their ability to correct 
information that is important for the patient's eye health or that 
could prevent improper substitution of lenses.\347\
---------------------------------------------------------------------------

    \343\ Health Care Alliance for Patient Safety (SNPRM Comment 
#128); Johnson & Johnson Vision Care, Inc. (SNPRM Comment #151).
    \344\ It is not clear that this option would be desired by 
prescribers, some of whom have indicated that they do not have time 
during business hours to respond to these requests or that such 
calls tie up their phone lines. See NPRM, 81 FR 88539 n.158.
    \345\ Id.; see also CLR Panel IV Tr., supra note 121, at 10 
(statement of David Cockrell that the office needs to be able to 
contact the seller immediately and it ``can't even leave a 
message'').
    \346\ CooperVision, Inc. (SNPRM Comment #130).
    \347\ CooperVision also stated confusion as to whether the 
Commission's requirement for sellers to provide an option to repeat 
the verification information included a requirement for sellers to 
provide the means for the prescriber to immediately disrupt an 
automatic call in order to connect with a live person. SNPRM Comment 
#130. It does not.
---------------------------------------------------------------------------

    The Rule does not require sellers' communication via telephone, 
email, or fax to occur during business hours. The Rule requires, 
instead, that sellers wait eight business hours after a valid 
verification call to sell the lenses. Moreover, the Rule already 
requires the seller to provide the name of a contact person at the 
seller's company, including facsimile and telephone numbers.\348\ 
Should a prescriber inform the seller within eight business hours that 
the prescription was inaccurate, expired, or otherwise invalid, the 
seller cannot lawfully sell those contact lenses. If a prescriber 
informs a seller that the verification request itself was non-
compliant, the seller is on notice that it may need to provide another 
verification request prior to selling the lenses. The prescriber need 
not relay that information to a person at the seller, whether during 
the verification

[[Page 50693]]

call or at other times.\349\ Instead, it is sufficient notice for a 
prescriber to leave a voicemail, or send a facsimile, that provides the 
seller with enough information so as to identify the consumer or order 
being called about (a consumer name, reference number, or even the 
prescriber's name with the date of the verification call could be 
adequate), and that the prescription is inaccurate, expired, or 
otherwise invalid.\350\ In addition, requiring sellers to reach a 
person (and not a machine) at the prescriber's office, or to provide a 
call-back number that is answered by a person (and not a machine), 
would mean either that sellers would need to have agents available at 
all times, or else only contact prescribers during business hours for 
both the seller and prescriber, which may be difficult if they are 
located in different time zones. Requiring that sellers have someone 
available at all times to respond to prescriber inquiries would also be 
costly for sellers, with no readily apparent countervailing benefit. 
For these reasons, the Commission declines to implement a requirement 
that sellers ensure that automated telephone messages are answered by a 
person at the prescriber's office, as opposed to a recording device, or 
that prescribers be able to reach a live person at the seller.\351\
---------------------------------------------------------------------------

    \348\ 16 CFR 315.5(b)(6).
    \349\ If a seller does not maintain a person to answer the phone 
number it provides, it must provide an opportunity for the 
prescriber to leave a message. A seller that does not check its 
voicemail runs the risk of selling lenses after a prescriber has 
timely invalidated or corrected the prescription, thereby violating 
the Rule.
    \350\ Final Rule Sec.  315.5(e) requires the prescriber to 
specify the basis for the inaccuracy or invalidity of the 
prescription, and if the prescription is inaccurate, the prescriber 
shall correct it. Final Rule 16 CFR 315.5(e). Even if the prescriber 
violates the Rule by failing to specify the basis for the inaccuracy 
or invalidity, or by failing to correct the prescription, the seller 
is still prohibited from selling if a prescriber informs the seller 
that the prescription is inaccurate, expired, or otherwise invalid 
within the eight-business-hour time period.
    \351\ The Commission notes that some sellers have agents who 
stay on the line to ensure that, before commencing the automated 
message, an individual at the prescriber's office has answered the 
phone, or that the answering machine has picked up before leaving 
the message. Such a practice helps ensure that the beginning of the 
message is not cutoff or played over hold music.
---------------------------------------------------------------------------

    The Health Care Alliance for Patient Safety and Johnson & Johnson 
Vision Care further requested a requirement that online sellers verify 
that they are making verification calls to the office of a legitimate 
eye care professional. The Commission is aware of allegations of 
sellers making verification calls to numbers clearly not affiliated 
with eye care prescribers. The Rule requires a seller to sell contact 
lenses in accordance with a contact lens prescription for the patient 
that, if not presented to the seller, is verified by direct 
communication.\352\ Of course, for prescription verification to be 
meaningful, that verification must go to the consumer's eye care 
prescriber. Although the seller does not know whether the prescriber 
contact information provided by the consumer is that of the consumer's 
own eye care prescriber, to ensure that its verification request 
complies with the Rule, it is incumbent upon the seller to ascertain 
whether the number provided by the consumer is for an eye care 
prescriber. If it is apparent from the consumer's entry itself,\353\ or 
from the seller's research on the internet or otherwise, that the 
number provided is not affiliated with a prescriber, or if it cannot be 
determined whether it is, the seller should either reach out to the 
consumer to obtain better contact information or cancel the order. 
Calls to numbers clearly not associated with eye care prescribers are 
not compliant verification requests, and any sales made pursuant to 
such requests violate the Rule. The Commission intends for this notice 
to provide sufficient guidance for sellers and does not see a need to 
amend the Rule to address this issue.
---------------------------------------------------------------------------

    \352\ 16 CFR 315.5(a).
    \353\ For instance, sellers should not verify a prescription 
when the consumer identifies the prescriber as ``Santa Claus.'' 
Similarly, sellers should not place verification calls to phone 
numbers that consumers list as the prescriber phone number when that 
phone number is the same number a consumer lists as her own contact 
number.
---------------------------------------------------------------------------

    The Commission is implementing the recommendations outlined in the 
SNPRM for automated telephone messages in the Final Rule, without 
modification. CooperVision requested guidance on how the Commission 
intends to interpret and enforce these provisions.\354\ This notice 
should provide sellers with information to assist them in complying 
with the new rule requirements. The Commission also plans to publish 
education on these Final Rule requirements. As to enforcement, should 
the Commission receive complaints about the quality of automated calls, 
it can request that the seller produce the recording of the call in 
question.
---------------------------------------------------------------------------

    \354\ CooperVision, Inc. (SNPRM Comment #130).
---------------------------------------------------------------------------

IV. Prescribers' Selection of Communication Mechanism

    In the NPRM, the Commission pointed out that the Act does not 
permit prescribers to limit the communication mechanism sellers may use 
to submit requests for verifying prescriptions, and that sellers are 
able to use any or all of the three delineated methods, telephone, 
facsimile, or electronic mail.\355\
---------------------------------------------------------------------------

    \355\ NPRM, 81 FR at 88542.
---------------------------------------------------------------------------

    In response, prescribers continued to request that they be able to 
select the method of communication used to submit verification requests 
from among telephone, facsimile, or electronic mail.\356\ Johnson & 
Johnson Vision Care commented that it wished to work with the 
Commission and Congress to improve prescriber-seller communications, 
such as by allowing a prescriber to select her preferred method for 
verification requests.\357\ The AOA commented that the Commission took 
a step in the right direction when it suggested that sellers evaluate 
whether honoring prescriber preferences with regard to communication 
method would increase the speed and efficiency of the verification 
process.\358\ It nevertheless urged the Commission to provide more 
instruction to sellers, and to outline the verification-related 
complaints that the Commission has received, so prescribers and sellers 
can work together to ensure patients receive the contact lenses that 
were prescribed.\359\
---------------------------------------------------------------------------

    \356\ O'Daniel (NPRM Comment #179); Krattli (NPRM Comment 
#1976).
    \357\ Johnson & Johnson Vision Care, Inc. (NPRM Comment #4327). 
The manufacturer also requested that sellers be required to provide 
an option, as part of a verification message, for the prescriber's 
office to elect an alternate means to receive the request, and an 
alternate time frame after which the window to respond to 
verification requests must be completed. Johnson & Johnson Vision 
Care, Inc. (SNPRM Comment #151).
    \358\ American Optometric Association (NPRM Comment #3830).
    \359\ Id.
---------------------------------------------------------------------------

    The Commission reiterates its suggestion that sellers and 
prescribers work together to ensure that patients receive their 
prescribed lenses. As stated in the NPRM, the Commission requests 
sellers to consider whether the speed and efficiency of the 
verification process would be increased by accommodating prescribers' 
requests to contact them with verification requests via a certain 
method.\360\ However, because the Act defines ``direct communication'' 
to include three different communication mechanisms that sellers may 
use--telephone, facsimile, or electronic mail--the Act does not permit 
prescribers to limit the communication mechanisms sellers may

[[Page 50694]]

use to submit verification requests.\361\ The Commission is therefore 
not making any changes to the Rule in this area.
---------------------------------------------------------------------------

    \360\ NPRM, 81 FR at 88542. Similarly, the seller should 
consider whether to accommodate prescribers' requests to contact 
them during specified time-periods (i.e., business hours, or after 
business hours).
    \361\ See 15 U.S.C. 7603(g). The Commission came to the same 
conclusion in its initial rulemaking. 69 FR at 40497. The Commission 
recognizes that in practice, sellers' options may be limited. For 
instance, should a prescriber's office not have facsimile, a seller 
would be unable to complete a verification request via fax.
---------------------------------------------------------------------------

V. Miscellaneous Passive Verification Issues

A. Active Verification Is Not Required

    In the NPRM, the Commission declined to propose replacing passive 
verification with active verification, despite concerns from many 
commenters.\362\ Commenters expressed concern that the passive 
verification system could easily be manipulated, for example, by a 
patient who provides false or incorrect prescriber information to a 
seller, or by a seller who sends the same verification request over and 
over again in the hope that the prescriber will fail to reply and deny 
one of them.\363\ However, because Congress decided to include a 
passive verification system in the Act, and the issues commenters 
raised were identical to those raised during the initial 2004 
rulemaking, the Commission chose not to revisit the decision to include 
passive verification.\364\
---------------------------------------------------------------------------

    \362\ NPRM, 81 FR at 88543.
    \363\ Id.
    \364\ Id.
---------------------------------------------------------------------------

    Following the NPRM, many commenters reiterated the same concerns 
with respect to passive verification, including that sellers could 
abuse the system or that consumers might obtain lenses without a 
prescription or receive incorrect lenses, and they advocated for a 
switch to active verification.\365\ Because these concerns are similar 
to those raised during the initial rulemaking in 2004 and because 
Congress mandated passive verification in the FCLCA, the Commission 
again declines to modify the Rule to require active verification.\366\ 
However, the Commission has made several changes to the Rule aimed at 
improving the quality of automated verification calls, which will allow 
prescribers to more effectively prevent the sale of contact lenses when 
the prescription is inaccurate, expired, or otherwise invalid.\367\ The 
Commission has also improved patients' access to their prescriptions by 
implementing requirements enabling patients to obtain electronic copies 
and additional copies of their prescriptions, and to present their 
prescriptions directly to sellers, which should reduce the need for 
passive verification requests.\368\ The Commission recognizes that some 
sellers may engage in verification practices that violate the Rule's 
requirements \369\ and, for that reason, will continue to monitor the 
marketplace and investigate potential violations when appropriate.
---------------------------------------------------------------------------

    \365\ See, e.g., Golden (WS Comment #1353); Weidel (WS Comment 
#2333); Gray (WS Comment #2730); Audia (NPRM Comment #698); Bazan 
(NPRM Comment #706); Dewart (NPRM Comment #897); Nixon (NPRM Comment 
#1510); Weissman (NPRM Comment #1676); Goshe (NPRM Comment #2597); 
Fritsch (NPRM Comment #2683); Garr (NPRM Comment #2858); Phan (NPRM 
Comment #3350). Some commenters continued to support passive 
verification. See 1-800 CONTACTS (WS Comment #3207); National 
Association of Optometrist and Opticians (WS Comment #3208) (``No 
changes are needed to the passive verification system.'').
    \366\ The Commission also notes that nothing in the Rule 
prevents active verification by a seller. If it prefers, a seller 
can choose to actively verify a prescription. CLR Panel IV Tr., 
supra note 121, at 5 (statement of Jennifer Sommer) (stating that 
Walmart often actively verifies prescriptions by calling the 
prescriber's office).
    \367\ See Section III, supra; 16 CFR 315.5(c)(2), (d).
    \368\ See Section II.C.5, supra, and Sections VII and VIII, 
infra.
    \369\ 16 CFR 315.5(a)-(d).
---------------------------------------------------------------------------

B. Concerns About Patient Manipulation

    In the NPRM, the Commission declined to propose any changes to the 
Rule to address concerns that patients were manipulating the passive 
verification system by deliberately providing inaccurate prescriber 
information to the seller.\370\ The Commission noted that if 
prescribers received a verification request for an individual who was 
not their patient, they have the ability to respond that such request 
is invalid, which would prevent the sale under Sec.  315.5 of the Rule. 
Some commenters provided anecdotal evidence of instances where 
consumers have intentionally provided inaccurate information, but the 
Commission did not have any empirical evidence showing the frequency of 
this problem.\371\ Moreover, Congress was aware that passive 
verification was not a foolproof method to prevent verification of 
invalid prescriptions, but nonetheless mandated passive verification to 
balance the interests of consumer health and prescription portability.
---------------------------------------------------------------------------

    \370\ NPRM, 81 FR at 88543.
    \371\ Id.
---------------------------------------------------------------------------

    In response to the NPRM, commenters continued to express concerns 
with patients being able to obtain contact lenses without a valid 
prescription, especially with only eight business hours to respond to a 
verification request, and with the potential health consequences.\372\ 
To address concerns with patient manipulation of passive verification, 
commenters advocated using an active verification system, requiring 
that a prescription be presented, changing the method used to send 
verification requests, or increasing the amount of time for a 
prescriber to respond.\373\
---------------------------------------------------------------------------

    \372\ See, e.g., Johnson & Johnson Vision Care, Inc. (SNPRM 
Comment #151); Lem (WS Comment #470); Dillehay (WS Comment #822); 
Baird (WS Comment #1918); Hemler (WS Comment #2312); Patel (WS 
Comment #2691); Gray (WS Comment #2730); Bottjer (WS Comment #3378); 
Tuttle (NPRM Comment #161); Gilberg (NPRM Comment #198); Moy (NPRM 
Comment #382); Engler (NPRM Comment #453); Francis (NPRM Comment 
#588); Stott (NPRM Comment #687); Kempf (NPRM Comment #915); 
McPherson (NPRM Comment #3397); Schlater (NPRM Comment #3504); 
Bengoa (NPRM Comment #3600); Jackson (NPRM Comment #3736).
    \373\ See, e.g., Contact Lens Association of Ophthalmologists, 
Inc. (WS Comment #770); Northsight Vision Care Center (WS Comment 
#1196); Golden (WS Comment #1353); Begeny-Mahan (WS Comment #1702) 
(requesting that the eight-business-hour period be changed to forty-
eight hours); Kirkconnell (WS Comment #1754) (requesting two 
business days to respond and stating that requests should be faxed); 
American Society of Cataract and Refractive Surgery (WS Comment 
#3142) (advocating for extending the eight-business-hour time-period 
for passive verification to five business days); Bazan (NPRM Comment 
#706); Garr (NPRM Comment #2858); Greitzer (NPRM Comment #3388).
---------------------------------------------------------------------------

    The Commission recognizes prescribers' concerns about the potential 
health effects on patients who wear non-prescribed lenses. However, as 
noted in the NPRM, Congress chose the passive verification framework as 
a way to balance consumer health and prescription portability.\374\ 
Congress also allowed verifications by direct communication, which it 
defined as including telephone, facsimile, and electronic mail.\375\ 
Congress was aware that passive verification was not a perfect method 
to prevent patients from deliberately providing incorrect 
information.\376\ The Commission does not have any evidence, aside from 
anecdotal reports, showing the extent to which patients are 
intentionally providing incorrect information to a seller in order to 
obtain contact lenses. Thus, the Commission does not believe that 
significant modifications to the Rule to address the concern about 
consumers submitting inaccurate prescriber information are warranted.
---------------------------------------------------------------------------

    \374\ NPRM, 81 FR at 88543.
    \375\ 15 U.S.C. 7603.
    \376\ NPRM, 81 FR at 88543.
---------------------------------------------------------------------------

    However, in its Final Rule, the Commission has implemented several 
changes to improve verification calls that use an automated telephone 
system, which will make it easier for prescribers to deny requests 
based on inaccurate prescriber information. These changes

[[Page 50695]]

include identifying at the start of the call that it is a prescription 
verification request, delivering the information in a slow and 
deliberate manner and at a reasonably understandable volume, and giving 
the prescriber the option to repeat the call.\377\ Prescribers will be 
better able to identify the relevant patient information and inform 
sellers during the eight-business-hour period that the request is 
invalid.\378\ The Commission will also continue to monitor the 
marketplace, investigate any sellers encouraging patients to provide 
false information, and continue its consumer education efforts 
communicating the importance of having a prescription when purchasing 
contact lenses.\379\
---------------------------------------------------------------------------

    \377\ See Section III.
    \378\ 16 CFR 315.5(d).
    \379\ See, e.g., Federal Trade Commission, Halloween know-how: 
Cosmetic contacts require an Rx, https://www.consumer.ftc.gov/blog/2019/10/halloween-know-how-cosmetic-contacts-require-rx; Federal 
Trade Commission, Prescription Glasses and Contact Lenses, https://www.consumer.ftc.gov/articles/0116-prescription-glasses-and-contact-lenses (``All contact lenses--even ones just meant to change your 
appearance--require a prescription.'').
---------------------------------------------------------------------------

C. Eight-Business-Hour Time Frame Is Appropriate

    In the NPRM, the Commission considered commenters' concerns that 
the eight-business-hour time frame was too short and that verification 
calls were being placed outside of business hours or when the 
prescriber's office was closed.\380\ The Commission declined to 
lengthen or otherwise modify the eight-business-hour time frame during 
which a prescriber must respond to a verification request.\381\ The 
Commission did not find sufficient evidence quantifying how the eight-
business-hour time frame imposed a significant burden or showing that a 
significant number of prescribers were unable to respond to the 
verification requests within the allotted time. The Commission further 
noted that there have been no compelling changes to the marketplace 
since the Rule was implemented in 2004 that would justify extending the 
period beyond eight business hours.
---------------------------------------------------------------------------

    \380\ NPRM, 81 FR at 88544-5. Other concerns about passive 
verification, unrelated to the length of time a prescriber has to 
respond to a verification request, are addressed in Sections III, 
IV, and V.A and B.
    \381\ Id.
---------------------------------------------------------------------------

    In response to the NPRM, some commenters indicated that eight 
business hours constituted a sufficient period for a prescriber to 
respond to a verification request.\382\ However, other commenters 
continued to express concerns with the limited time frame,\383\ 
particularly due to the potential negative health consequences for 
patients wearing non-prescribed lenses, should a prescriber fail to 
deny an invalid verification request in time.\384\ Many prescribers 
wrote that eight business hours was just not a sufficient amount of 
time to respond due to, for example, busy offices, limited staff, high 
volume of requests, and regular office closures on business days.\385\
---------------------------------------------------------------------------

    \382\ Coalition for Contact Lens Consumer Choice (WS Comment 
#3239); Consumer Action (NPRM Comment #3721); Consumers Union (NPRM 
Comment 3969) (stating that eight business hours ``was generally 
sufficient and has proven workable,'' but suggesting that the period 
could be changed to twenty-four hours with weekends and holidays 
excluded); see also CLR Panel IV Tr., supra note 121, at 16 
(statement of Cindy Williams) (stating that eight hours is 
sufficient time to respond).
    \383\ See, e.g., Becker (WS Comment #571); Contact Lens 
Association of Ophthalmologists, Inc. (WS Comment #770); Begeny-
Mahan (WS Comment #1702) (requesting that the eight-business-hour 
period be changed to forty-eight hours); Kirkconnell (WS Comment 
#1754) (requesting two business days to respond and stating that 
requests should be faxed); American Society of Cataract and 
Refractive Surgery (WS Comment #3142) (advocating for extending the 
eight-business-hour time-period for passive verification to five 
business days); Hanen-Smith (NPRM Comment #154); Cade (NPRM Comment 
#2163) (suggesting that sellers should exclude a weekday from the 
eight-business-hour calculation if they become aware that the 
prescriber's office is closed); American Academy of Opthalmology 
(NPRM Comment #3657) (proposing lengthening the response period to 
two business days); Coalition for Patient Vision Care Safety (NPRM 
Comment #3883); Contact Lens Association of Ophthalmologists (NPRM 
Comment #4259) (asking that the period be extended to two days).
    \384\ See, e.g., Rhee (WS Comment #3468); Meyers (NPRM Comment 
#173); Gilberg (NPRM Comment #198); Engler (NPRM Comment #453); 
Kempf (NPRM Comment #915); McPherson (NPRM Comment #3397); American 
Society of Cataract and Refractive Surgery (NPRM Comment #3820); 
Tesinsky (NPRM Comment #4012).
    \385\ Boyer (SNPRM Comment #59); Becker (WS Comment #571) 
(recommending two business days); Contact Lens Association of 
Ophthalmologists, Inc. (WS Comment #770); Begeny-Mahan (WS Comment 
1702) (stating that the eight-hour period is a problem because the 
office is closed on Wednesdays); Huynh (WS Comment #1940); Dhaliwal 
(WS Comment #2684); American Society of Cataract and Refractive 
Surgery (WS Comment #3142); Morales (WS Comment #3404); Yu-Davis (WS 
Comment #3410), Rhee (WS Comment #3468); Meyers (NPRM Comment #173); 
Pierce (NPRM Comment #187) (estimating that the office spends 
approximately twelve minutes responding to a verification request); 
Kempf (NPRM Comment #915) (stating that the office is closed on 
Wednesdays and incorrect prescriptions received late on Tuesday will 
be filled); Goodman (NPRM Comment #1340) (stating that the 
prescriber is unable to respond to requests within the eight-hour 
period because the office is closed on Mondays); Speiser (NPRM 
Comment #2233) (stating that eight hours are not enough time because 
the doctor spends time at the hospital and is not in the office 
every day); Weingeist (NPRM Comment #2496) (stating that the 
practice is small and the requests are burdensome); American Society 
of Cataract and Refractive Surgery (NPRM Comment #3820); McPherson 
(NPRM Comment #3397) (stating that the office is very busy with 
patients and verification requests can be forgotten).
---------------------------------------------------------------------------

    The Commission considered these comments and, for the reasons 
stated in the NPRM, declines to change the eight-business-hour period, 
including by lengthening the period or changing how the period is 
calculated. Congress mandated the verification system and that a 
prescriber respond within ``8 business hours, or a similar time as 
defined by the Federal Trade Commission.'' \386\ In determining this 
time period, Congress balanced the harm to consumers if they were 
unduly delayed in receiving their contact lenses against the harm from 
receiving contact lenses based on an invalid prescription.\387\ The 
Commission does not find any compelling changes to the marketplace 
since the Rule's promulgation in 2004 that support extending the eight 
business hour period.\388\
---------------------------------------------------------------------------

    \386\ NPRM, 81 FR at 88544. Some prescribers or sellers may be 
confused about when the eight-business-hour period starts following 
a verification request and the applicable time zone. See, e.g., 
Goodman (WS Comment #599); Palmer (WS Comment #2215); Wang (WS 
Comment #3448); Gilberg (NPRM Comment #198); Huff (NPRM Comment 
#1964); Osterholzer (NPRM Comment #2085) (stating that the office is 
not open during the same hours as the seller and in a different time 
zone). Under the Rule, when a request is received after 5 p.m., the 
eight-business- hour period would not start until 9 a.m. the next 
weekday that is not a federal holiday, or if applicable, on Saturday 
at the beginning of the prescriber's actual business hours. A 
business hour is determined based on the time zone of the 
prescriber. 16 CFR 315.2, 315.5.
    \387\ NPRM, 81 FR at 88544.
    \388\ The Commission recognizes a need for clarification with 
respect to whether a seller can ship lenses to a consumer after 
receiving notification from a prescriber that the submitted 
prescription is inaccurate, invalid, or expired but when such 
notification occurs after the eight-business-hour period has passed. 
In its initial rulemaking, the Commission declined to expressly 
prohibit sellers from shipping lenses in such an instance, but noted 
that nothing in the Rule prohibits a prescriber from submitting late 
notifications to the seller or the seller from acting upon them, and 
that it would likely be in the best interest of their mutual 
consumer for them to do so. Contact Lens Rule, 69 FR 40050. However, 
the Commission is aware that the marketplace for contact lens sales 
now includes subscription models, in which sellers provide a 
quantity of lenses to consumers, not in a single-delivery supply, 
but rather in periodic installments (usually every month, although 
sometimes quarterly or semi-annually). In such a circumstance, the 
seller would have plenty of time to halt a subsequent installment 
shipment after being informed that the consumer's prescription was 
invalid, inaccurate, or expired. Therefore, the Commission clarifies 
that while the Rule does not prohibit an initial shipment to a 
consumer in instances where the seller received such notification 
after the eight-business-hour period has passed, any subsequent 
shipments based on the initial verification request would violate 
the Rule. A seller who has been notified that the patient does not 
have a valid prescription cannot ignore such notification and 
continue to sell and ship lenses every month simply because the 
notification came in after the eight-business-hour deadline.

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[[Page 50696]]

VI. Seller Alteration of Contact Lens Prescriptions and Private Label 
Concerns

    The current Rule states that a ``seller may not alter a contact 
lens prescription.'' The only exception applies to private label 
contact lenses and allows the seller, when a patient has a prescription 
for private label contact lenses, to substitute identical contact 
lenses that the same company manufactures and sells under a different 
name.\389\
---------------------------------------------------------------------------

    \389\ 16 CFR 315.5(e).
---------------------------------------------------------------------------

    In the SNPRM, the Commission expressed its concern about the 
emergence of sellers' business models that rely exclusively on passive 
verification as a means to substitute their own brand of contact lenses 
for the prescribed lens.\390\ As noted in the SNPRM, many prescribers 
detailed harm that resulted from wearing unprescribed lenses, such as 
headaches, corneal neovascularization, corneal ulcers, and other 
irreversible and vision-threatening diagnoses.\391\ As a result, the 
Commission proposed two modifications to the Rule.
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    \390\ SNPRM, 84 FR at 24687-88.
    \391\ Id. at 24686.
---------------------------------------------------------------------------

    The first modification proposed in the SNPRM, adding a paragraph 
(g) to Sec.  315.5, would require sellers to provide a clear and 
prominent method for the patient to present the seller with a copy of 
the patient's prescription. Such method might include, without 
limitation, electronic mail, text message, file upload, or facsimile. 
The Commission stated that this proposal would address prescriber and 
manufacturer concerns by increasing the number of patients who present 
online sellers with their prescriptions rather than relying on 
verification.\392\
---------------------------------------------------------------------------

    \392\ Id. at 24688.
---------------------------------------------------------------------------

    The second modification proposed in the SNPRM targeted concerns 
about prescription verification more directly. The proposed 
modification of Sec.  315.5(f) would define alteration to include a 
seller's providing, as part of a verification request, a prescriber 
with a manufacturer or brand other than that specified on a patient's 
prescription. The proposal included an exception, however, for sellers 
when they provide a manufacturer or brand that a patient provided to 
the seller, either on the order form or orally in response to a request 
for the manufacturer or brand listed on the prescription. In other 
words, to avail themselves of the exception, sellers must ask consumers 
to provide the manufacturer or brand listed on their prescription. The 
SNPRM further provided that a seller would not be able to avail itself 
of the exception by relying on a prepopulated or preselected box, or on 
consumers' online searches for a particular manufacturer or brand, as 
an indication that they were prescribed that manufacturer or 
brand.\393\ A seller not covered under the exception discussed above 
who made a verification request containing a manufacturer or brand 
other than, and not identical to, the one written on the consumer's 
prescription by their prescriber, would violate the Rule, even if a 
prescriber subsequently invalidated the request and the lenses were 
never sold.\394\
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    \393\ Id. at 24689.
    \394\ Id.
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A. The Final Rule Includes a Requirement for Sellers To Accept 
Prescription Presentation

    Commenters who discussed the Commission's proposal to require 
sellers to provide a clear and prominent method to present 
prescriptions were unanimous in their support, although some suggested 
revisions that they believed would make it more effective.\395\ A 
number of commenters asserted that this amendment would help decrease 
the number of verification requests \396\ and eliminate errors stemming 
from incorrect verification requests.\397\ In addition, the NAOO 
pointed out that such presentation benefits the consumer and the seller 
by reducing the time needed to fill the order and providing additional 
assurance of the prescription's validity.\398\ 1-800 CONTACTS also 
supported--and says that it already complies with--the prescription 
presentation proposal.\399\ Simple Contacts commented that the proposed 
requirement is fair, and opined that ``any seller who does not support 
prescription presentation has not made a good faith attempt to 
accurately verify all patient prescriptions.'' \400\ Simple Contacts, 
however, expressed skepticism that the amendment would significantly 
reduce the number of alterations by sellers abusing the passive 
verification system.\401\
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    \395\ Simple Contacts (SNPRM Comment #87); American Optometric 
Association (SNPRM Comment #96); Health Care Alliance for Patient 
Safety (SNPRM Comment #128); National Association of Optometrists 
and Opticians (SNPRM Comment #129); 1-800 CONTACTS (SNPRM Comment 
#135); Johnson & Johnson Vision Care, Inc. (SNPRM Comment #151).
    \396\ Health Care Alliance for Patient Safety (SNPRM Comment 
#128); National Association of Optometrists and Opticians (SNPRM 
Comment #129); Johnson & Johnson Vision Care, Inc. (SNPRM Comment 
#151).
    \397\ Health Care Alliance for Patient Safety (SNPRM Comment 
#128); National Association of Optometrists and Opticians (SNPRM 
Comment #129); 1-800 CONTACTS (SNPRM Comment #135); Johnson & 
Johnson Vision Care, Inc. (SNPRM Comment #151).
    \398\ National Association of Optometrists and Opticians (SNPRM 
Comment #129).
    \399\ 1-800 CONTACTS (SNPRM Comment #135).
    \400\ Simple Contacts (SNPRM Comment #87). See also National 
Association of Optometrists and Opticians (SNPRM Comment #129) 
(``Contact lens sellers that do not provide a method to upload the 
prescription may be trying to avoid getting the patient's specific 
brand information, so that they can switch the patient into a 
different proprietary brand.'').
    \401\ Simple Contacts (SNPRM Comment #87). The Health Care 
Alliance for Patient Safety stated that ``it is unclear whether the 
proposed amendment would have any effect on the incidence of 
alteration[s]'' since the Commission is not also prohibiting calls 
containing automated verification messages. SNPRM Comment #128.
---------------------------------------------------------------------------

    Because the Commission did not receive any comments opposing this 
proposal, the Commission is incorporating the requirement in its Final 
Rule. The Commission believes the proposal will help reduce the number 
of verifications, reduce errors associated with incorrect verification 
attempts, and make it more difficult for ill-intentioned sellers to 
abuse the passive verification framework and take advantage of 
consumers who might not realize that the seller intends to verify a 
different lens than the one written on their prescription.
    In the Final Rule, the Commission has changed the ``clear and 
prominent'' requirement to pertain to a disclosure of the method of 
prescription presentation (e.g., a disclosure that the method is 
available to provide the prescription). In so doing, the Commission 
makes clear that sellers cannot provide a method of prescription 
presentation without also providing a clear and prominent disclosure 
thereof.\402\ The Commission has retained the requirement that the 
method (e.g., email address, phone number to receive text messages, or 
upload link) be prominent.\403\ The Commission has also determined that 
it is unnecessary to include prescribers in this section of the Rule 
since it pertains to the ordering process between a seller and a 
consumer.\404\
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    \402\ For telephone orders, sellers would comply by making a 
prominent method available and giving clear and prominent notice of 
the method.
    \403\ The Commission finds its proposed SNPRM requirement that 
the method be clear unnecessary given the new language requiring the 
disclosure of the method to be clear and prominent.
    \404\ The Rule anticipates prescription presentation by 
prescribers to sellers. Section 315.5(a)(1) indicates that one way 
sellers can sell contact lenses is if they receive a prescription 
from a prescriber directly or by facsimile. 16 CFR 315.5(a)(1).
---------------------------------------------------------------------------

    Commenters suggested three additional requirements for the 
prescription presentation proposal. First, the NAOO suggested the

[[Page 50697]]

Commission require that the method to present prescriptions be in close 
proximity to the option to provide the parameters of the contact lens 
for verification, so as to increase the likelihood that consumers would 
understand they have a choice between providing a prescription or 
having one verified with their prescriber.\405\ As drafted, the 
language did not specify at what point in the process a seller must 
make the method for prescription presentation available. The Commission 
believes that the NAOO's suggestion of close proximity would be 
helpful, but notes that if the method, and a disclosure thereof, are 
provided in close proximity but after the collection of all information 
required for verification is provided, the prescription presentation 
benefit may be diminished. In other words, if a consumer enters all the 
information required for verification (contact lens brand, powers, 
prescriber name and phone number) before learning about prescription 
presentation, and having an opportunity to present the prescription, 
the consumer may choose not to also provide the prescription. As a 
result, the Commission is amending the language of Sec.  315.5(g) in 
the Final Rule to require that the method and the disclosure of the 
method for the patient to present the seller with a copy of the 
patient's prescription must be prior to requesting a prescriber's 
contact information, which is necessary to verify a contact lens 
prescription.\406\
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    \405\ National Association of Optometrists and Opticians (SNPRM 
Comment #129).
    \406\ In the case of orders placed by telephone, the Rule 
requires sellers to provide clear and prominent disclosure of the 
method for prescription presentation (e.g., a seller's email 
address) prior to requesting a prescriber's contact information.
---------------------------------------------------------------------------

    Two commenters opined on whether consumers should be able to choose 
the method for providing their prescriptions. Consumer Reports stated 
its belief that, when offering prescription presentation, sellers 
should be required to provide consumers all four methods listed in the 
proposed Rule--electronic mail, text message, file upload, and 
facsimile--in lieu of giving sellers the option to choose from those 
methods.\407\ It indicated that requiring all four would not burden the 
seller, and there may be reasons that patients prefer one option over 
the others.\408\ On the other hand, the NAOO supported the Commission's 
proposal to let the seller decide the method.\409\ The Commission has 
decided to require sellers to offer prescription presentation by the 
same medium through which the order is placed, or by electronic mail, 
text message, or file upload.\410\ When orders are placed via 
telephone, sellers are required to offer prescription presentation via 
electronic mail, text message, or file upload. Because faxes are not 
commonly used by consumers, sellers can offer fax presentation as the 
sole option only when the orders are placed by fax. This framework 
gives consumers and prescribers an opportunity to present 
prescriptions, while limiting the burden on sellers, some of whom are 
small.\411\ The Commission believes that these changes from the SNPRM 
proposal are not significant, are consistent with the stated purpose of 
the proposal as outlined in the SNPRM,\412\ and will help ensure the 
maximum benefit from the Rule change.
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    \407\ Consumer Reports (SNPRM Comment #133).
    \408\ Id.
    \409\ National Association of Optometrists and Opticians (SNPRM 
Comment #129).
    \410\ A seller who chooses to offer all methods will likely 
benefit by having more consumers provide prescriptions than if it 
offered only one or even two methods. Benefits to sellers from 
having prescriptions on file include avoiding the costs involved in 
verification, and having the ability to provide contact lenses more 
quickly than relying on verification.
    \411\ For all orders, sellers can meet the requirement by 
accepting prescriptions via email. There should not be a significant 
burden on business to obtain and maintain an email address and 
process and store prescriptions received through email.
    \412\ SNPRM, 84 FR at 24688-89.
---------------------------------------------------------------------------

    Consumer Reports also recommended that sellers be required not just 
to accept prescription presentation, but also to specifically request 
and encourage patients to provide prescriptions.\413\ The Commission 
declines to adopt this suggestion. The Commission's Final Rule requires 
sellers to accept prescriptions. The Final Rule also requires that 
sellers clearly and prominently disclose how consumers can provide them 
with prescriptions. Sellers that more overtly request or encourage the 
submission of prescriptions (e.g., through price cuts and faster 
delivery times) will likely further increase the number of 
prescriptions presented, allowing both sellers and consumers to reap 
the benefits. However, the Commission has determined that beyond 
providing a method for consumers to present their prescriptions and 
notice of such method prior to requesting their prescriber's contact 
information, sellers should have discretion whether to promote or 
incentivize that practice.
---------------------------------------------------------------------------

    \413\ Consumer Reports (SNPRM Comment #133).
---------------------------------------------------------------------------

B. Alteration Includes a Seller Providing a Prescriber With a 
Verification Request for a Non-Prescribed Manufacturer or Brand, but 
Includes an Exception for Verifying a Manufacturer or Brand That a 
Consumer Indicates Is on Her Prescription

    In the SNPRM, the Commission proposed a modification of Sec.  
315.5(f) to define alteration to include a seller's providing, as part 
of a verification request, a prescriber with a manufacturer or brand 
other than that specified on a patient's prescription. The proposal 
included an exception, however, for sellers when they provide in a 
verification request a manufacturer or brand that a patient provided to 
the seller, either on the order form or orally in response to a request 
for the manufacturer or brand listed on the prescription.\414\ As 
discussed below, in the Final Rule, the Commission has determined to 
adopt this definition of alteration along with a modified version of 
the accompanying exception.
---------------------------------------------------------------------------

    \414\ SNPRM, 84 FR at 24698.
---------------------------------------------------------------------------

1. The Final Rule Modifications Regarding Alteration Are Beneficial and 
Address Abuses of the Verification System
    1-800 CONTACTS expressed its belief that the proposed alteration 
modification was unnecessary and requested that the Commission 
carefully evaluate any new regulations that could interfere with the 
convenience and competitive pricing of legitimate sellers.\415\ 
Although the seller recognized the presence of single-brand sellers in 
the market, and the problems some cause, 1-800 CONTACTS stated that the 
addition of quality standards for verification calls, along with 
targeted enforcement against sellers with a business model based solely 
on noncompliant verification methods, would reduce the ability of these 
sellers to profit from abusing the passive verification system.\416\ 
Specifically, it felt that ``enforcement against one such business [ ] 
would likely be sufficient to chill or completely eliminate replication 
of this business model.'' \417\ The Commission agrees that the 
requirement to provide a method for prescription presentation, and a 
disclosure thereof, should reduce the number of verification requests, 
and that the addition of quality standards for verification calls 
should reduce the incidence of non-compliant verification calls and 
increase the ability of prescribers to deny invalid requests or

[[Page 50698]]

correct inaccurate ones. However, based on comments from prescribers as 
well as its own investigations and experience, the Commission believes 
those amendments on their own are inadequate to curb the practice of 
substitution to non-prescribed brands through abuse of the verification 
system. The Commission has previously stated that, under the existing 
Rule, a verification request is not valid and does not commence the 
eight-business-hour verification period if a seller knows or should 
know that the verification request includes a different brand and 
manufacturer than that prescribed.\418\ Any sales after such requests 
violate the Rule, even if a prescriber has not responded. In these 
instances, the seller is not selling in accordance with a prescription. 
Despite clearly articulating this position, the FTC continues to 
receive reports about the proliferation of passive verification abuses. 
Furthermore, sellers may argue that they are technically compliant with 
the Rule because they submitted verification requests and prescribers 
had an opportunity to respond to the requests. They may also argue that 
they did not have knowledge that a consumer did not have a prescription 
for that manufacturer or brand of lens.
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    \415\ 1-800 CONTACTS (SNPRM Comment #135).
    \416\ Id.
    \417\ Id.
    \418\ SNPRM, 84 FR at 24687-88.
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    Additionally, this is not an issue of one bad actor. As noted in 
the SNPRM, the Commission has seen the emergence of businesses that 
rely exclusively, or almost exclusively, on passive verification as a 
means to substitute their own brand of contact lenses.\419\ Simple 
Contacts' comment notes that, within the last two years, several new 
companies have entered the U.S. market and that their abuse of the 
verification system appears willful.\420\ The AOA similarly noted an 
increase of direct-to-consumer brands and named three new market 
entrants that reportedly replace their own brand of lenses for the 
prescribed brand.\421\ The Commission therefore sees benefits to 
defining alteration to include a seller's providing a prescriber, as 
part of a verification request, with a manufacturer or brand other than 
that specified on a patient's prescription.
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    \419\ SNPRM, 84 FR at 24687.
    \420\ Simple Contacts (SNRPM Comment #87).
    \421\ American Optometric Association (SNPRM Comment #96).
---------------------------------------------------------------------------

2. Comments Related to the Exception to Alteration When a Seller 
Provides the Manufacturer or Brand of Lenses That a Consumer Provides 
in Response to a Seller's Request for That Information
    The SNPRM proposed that sellers receive an exception from 
alteration when they provide, in a verification request, a manufacturer 
or brand that a patient provided to them, either on the order form or 
orally in response to a request for the manufacturer or brand listed on 
the prescription.\422\ If the seller seeks to verify a manufacturer or 
brand other than that indicated by the consumer, even if a prescriber 
ultimately denies the request, the seller has committed a violation. 
The implementation of the alteration definition, including the 
exception, should serve as an effective deterrent against sellers that 
try to game the verification system to sell non-prescribed contact 
lenses.
---------------------------------------------------------------------------

    \422\ SNPRM, 84 FR at 24686.
---------------------------------------------------------------------------

    In response to the SNPRM, commenters expressed concerns that some 
sellers might take advantage of the exception by inducing, suggesting, 
advertising, or otherwise causing consumers to provide a name other 
than that on their prescription so as to allow the seller to seek 
verification of a brand that had not been prescribed for the 
consumer.\423\ The NAOO was specifically concerned that ``less 
scrupulous sellers'' would attempt to take advantage of this exception, 
and noted that currently some sellers only request the power of the 
lenses from the customer and then ask prescribers to verify a 
prescription with a private label brand.\424\ Commenters proffered 
different recommendations as to how to address this issue. CooperVision 
requested that the Commission state in a guidance document that sellers 
cannot induce, suggest, advertise, or otherwise cause patients to 
provide the wrong name, and to provide examples of improper 
statements.\425\ Johnson & Johnson Vision Care suggested that, should 
the Commission retain the exception, it should add the following 
clarifying language to the preamble section of the Rule: ``This 
exception is intended to provide explicit direction for sellers as to 
when they are responsible for instances of prescription alteration. 
Under no circumstances may a seller, wishing to avail themselves of 
this exception, direct, encourage, motivate, or suggest, either 
implicitly or explicitly, that a patient enter any manufacturer or 
brand other than that listed on the patient's prescription.'' \426\ The 
NAOO recommended that the Rule itself be further amended to provide 
more specific direction as to what the seller must, may, and cannot do 
when asking patients for the information the FCLCA requires in a 
verification request. Specifically, it recommended adding a requirement 
that to avail itself of the exception, a seller must have had no reason 
to believe that the name provided by the consumer was not the 
manufacturer or brand listed on that consumer's prescription.\427\
---------------------------------------------------------------------------

    \423\ National Association of Optometrists and Opticians (SNPRM 
Comment #129); CooperVision, Inc. (SNPRM Comment #130); Johnson & 
Johnson Vision Care, Inc. (SNPRM Comment #151).
    \424\ National Association of Optometrists and Opticians (SNPRM 
Comment #129).
    \425\ CooperVision, Inc. (SNPRM Comment #130).
    \426\ Johnson & Johnson Vision Care recognized that the 
exception could serve as guidance for sellers to determine whether 
they are responsible for an illegal prescription alteration. 
However, it believes the exception should not be added to the Rule 
because a patient may not be able to correctly enter their 
information given the nuances of a contact lens prescription and the 
meaning of the different elements therein. Ultimately, Johnson & 
Johnson Vision Care is concerned that the exception may contribute 
to passive verification of an inaccurate prescription, and thus, 
illegal substitution. SNPRM Comment #151. The Commission does not 
believe that this concern is relevant to the exception, which 
relates to a consumer only providing her manufacturer or brand.
    \427\ National Association of Optometrists and Opticians (SNPRM 
Comment #129).
---------------------------------------------------------------------------

    The Commission agrees that sellers must not induce, suggest, 
advertise, or otherwise lead consumers to provide a manufacturer or 
brand different from that listed on their prescriptions. The Commission 
believes, however, that the recommended change is unnecessary because, 
should a seller attempt to induce or trick the consumer into providing 
the seller with a manufacturer or brand different from that listed on 
the consumer's prescription, it would not be able to avail itself of 
the exception. Any such conduct by the seller would call into question 
whether the consumer had provided the seller with the manufacturer or 
brand listed on her prescription in response to a clear request for 
such information, as required by the Rule.
    Commenters expressed concern that the exception for patient 
prescription entry would allow consumers to override their 
prescriptions by providing a manufacturer or brand of contact lenses 
other than that prescribed to them by their prescriber.\428\ Similarly, 
one commenter stated that sellers should ensure that consumers 
understand that they need to request the lens specified on their 
prescription and, if consumers want a different lens,

[[Page 50699]]

sellers shall state prominently that consumers must discuss the request 
with, and make the change through, their prescribers.\429\ The concern 
that this amendment gives consumers permission to override their 
prescriptions, including choosing a new brand, is unfounded. The 
exception in no way gives consumers the ability to override 
prescribers' prescriptions, and it does not change the prescriber's 
ability to inform a seller that the prescription submitted for 
verification is inaccurate, expired, or otherwise invalid.\430\ In 
fact, by requiring sellers to ask consumers their manufacturer or brand 
to meet the exception, the proposal is encouraging just the opposite--
inviting consumers to choose the brand prescribed for them. And, once 
the seller receives a communication from the prescriber that the 
prescription is invalid, it cannot sell the lenses without violating 
the Rule. The Commission therefore does not see a need to require 
sellers to inform consumers that if they want a different lens, they 
must go to their prescribers. Asking consumers for the manufacturer or 
brand listed on their prescriptions, and clarifying that sellers may 
not induce, suggest, or otherwise cause consumers to select or provide 
a manufacturer or brand other than that prescribed, should be adequate 
to curtail much of the illegal alterations occurring through abuse of 
the verification system. Moreover, the Commission has issued consumer 
notices that indicate that if consumers wish to switch their brand of 
lens, they need to contact their prescribers.\431\ The Commission will 
continue its educational efforts in this area.
---------------------------------------------------------------------------

    \428\ American Optometric Association (SNPRM Comment #96); 
Health Care Alliance for Patient Safety (SNPRM Comment #128).
    \429\ CooperVision, Inc. (SNPRM Comment #130).
    \430\ Final Rule 16 CFR 315.5(e). Despite this prohibition, 
substitution to another brand of lenses was always a risk with 
passive verification, but it was a risk Congress considered before 
instituting the verification framework set forth in the Act. See, 
e.g., FCLCA Subcomm. Hearing, supra note 17 (statements of Howard 
Beales, Federal Trade Commission); id. (statements of J. Pat 
Cummings, American Optometric Association) (``And the problem with 
passive verification is that people will get contact lenses without 
a prescription.'').
    \431\ See, e.g., Federal Trade Commission, Prescription Glasses 
and Contact Lenses, https://www.consumer.ftc.gov/articles/0116-prescription-glasses-and-contact-lenses (last visited Nov. 19, 
2019).
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3. Comments Regarding and Commission Guidance on Acceptable Methods for 
Obtaining the Brand or Manufacturer Listed on Consumers' Prescriptions
    1-800 CONTACTS expressed concern that the Commission's amendment 
might interfere with its ability to improve the user experience. It 
indicated that it sells hundreds of brands of lenses and offers 
consumers a variety of methods to identify their brand, including drop-
down menus, a search box, and filters that display lenses by brand, 
modality, and other parameters and that some consumers do not enter 
their brand information on an order form.\432\
---------------------------------------------------------------------------

    \432\ 1-800 CONTACTS (SNPRM Comment #135).
---------------------------------------------------------------------------

    Simple Contacts asked for greater specificity on the acceptable 
mechanisms for soliciting the contact lens brand or manufacturer, as a 
way to prevent bad actors from finding mechanisms to circumvent the 
intent of the Rule. Simple Contacts recommended limiting such 
mechanisms to five: Providing verbal confirmation of the brand or 
manufacturer; providing a copy of a prior prescription indicating the 
brand or manufacturer; typing a selection into a free entry text or 
search field; selecting a brand or manufacturer from a list or database 
containing the majority of commercially available brands (e.g., a drop-
down menu), or providing a photo of a contact lens box.\433\
---------------------------------------------------------------------------

    \433\ Simple Contacts (SNPRM Comment #87). The NAOO also stated 
that a seller should be able to rely on a customer-provided 
photograph of packaging of contact lenses for a current 
prescription. SNPRM Comment #129.
---------------------------------------------------------------------------

    Johnson & Johnson Vision Care opined that should the Commission 
proceed with the exception, a seller should not be able to avail itself 
of the exception by relying on a prepopulated or preselected box, or on 
consumers' online searches for a particular brand or manufacturer, as a 
representation by consumers that they do, in fact, have a prescription 
for that brand or manufacturer. In contrast to the view expressed by 1-
800 CONTACTS and Simple Contacts, Johnson & Johnson Vision Care 
requested the Commission prohibit drop-down menus and similar tools as 
methods by which a seller could avail itself of the exception.\434\
---------------------------------------------------------------------------

    \434\ Johnson & Johnson Vision Care, Inc. (SNPRM Comment #151).
---------------------------------------------------------------------------

    The Commission agrees that greater specificity surrounding 
acceptable methods would benefit sellers trying to comply with the 
Rule, but recognizes the myriad of ways consumers can interact with 
sellers to purchase lenses. Specifically, the Commission agrees that 
the requirement to provide the manufacturer or brand if not orally, 
then on an order form, imposes unnecessary limits for a consumer to 
select her manufacturer or brand. As a result, it is removing the term 
``order form'' from the Final Rule. However, while sensitive to 
sellers' needs to create the best and most convenient consumer 
experience, the Commission believes requiring that they ask for the 
name of the manufacturer or brand listed on consumers' prescriptions 
can still be done while providing a positive purchasing experience for 
their customers.
    At a minimum, in order for sellers to consider the consumer's 
indication of manufacturer or brand as adequate to qualify for the 
exception, the manufacturer or brand must be: (1) Provided in response 
to a seller's request for the manufacturer or brand listed on the 
consumer's prescription, and (2) an affirmative statement or selection 
by the consumer, not a preselected or prefilled entry (collectively 
``the minimum criteria''). As to the first minimum criterion, a seller 
cannot assume that a consumer who searches on the internet for a 
specific manufacturer or brand of lens has a prescription for that 
manufacturer or brand of lens. Similarly, a consumer's selection next 
to a request for the manufacturer or brand the consumer wears or wishes 
to purchase would be insufficient because a consumer may be wearing or 
attempting to order a non-prescribed lens. In contrast, a seller can 
reasonably rely on a consumer's entry of a manufacturer or brand in 
response to a request for the ``manufacturer or brand listed on your 
prescription.'' The second minimum criterion for sellers to qualify for 
the exception is that they must elicit from the consumer an affirmative 
statement or selection of the manufacturer or brand. A seller that 
relies on a preselected, prechecked box stating ``I agree I have a 
prescription for this brand,'' or something similar, would not qualify 
for the exception to alteration. For telephone orders, the consumer 
must state the name of the manufacturer or brand in response to a 
seller's request for the manufacturer or brand listed on her 
prescription.\435\ A seller can rely on a consumer-provided photograph 
of a contact lens box or a copy of a prior prescription so long as the 
seller meets the two minimum criteria listed above and obtains 
additional information from the consumer or prescriber that the 
consumer has a current prescription for that brand.\436\
---------------------------------------------------------------------------

    \435\ A seller receiving an affirmative response to its request 
``Do you have a prescription for this brand?'' would be unable to 
meet the exception.
    \436\ The information from the prescriber or consumer would 
provide the seller with a basis for the verification other than the 
expired prescription. See Section X.B., supra and NPRM, 81 FR at 
88546-67 (a seller may not use an expired prescription as the basis 
for a verification request).
---------------------------------------------------------------------------

    The Commission is not limiting the permissible methods for 
obtaining

[[Page 50700]]

manufacturer or brand to meet the exception to only those discussed 
above. The Commission instead is leaving sellers the option of deriving 
other ways to elicit the prescribed manufacturer or brand, within the 
guidelines discussed in this section. The Commission also declines to 
add a preamble further explaining the ways for sellers to meet the 
exception, but instead relies on this notice as guidance.
    1-800 CONTACTS opined that the Commission should not refer to 
``brand'' in the amendment to the Rule as that language does not appear 
elsewhere in the Rule. It points out that the Rule defines a 
prescription as including a ``material or manufacturer or both'' and 
that the Commission's inclusion of the reference to brand imposes an 
additional limit on consumer choice that the Act does not require. 1-
800 CONTACTS requested instead that the exception to the Rule be 
applicable to ``providing the prescriber with the name of a 
manufacturer or material other than that specified by the patient's 
prescriber . . . .'' The reference to brand in the definition of 
alteration and in the exception would indeed be the only references to 
brand in the Rule. However, in practice, it appears many, if not most, 
prescriptions list the manufacturer's brand, not the manufacturer or 
material, and the brand is viewed as shorthand for the entire 
device.\437\ Furthermore, very few consumers know the manufacturer or 
material of contact lens that they wear, and typically refer to their 
lenses by brand name. Amending the exception in the way 1-800 CONTACTS 
recommended would be unworkable since many consumers would be unable to 
provide the manufacturer or material in response to a seller's request, 
and might even have to ask their prescribers. Should prescribers' 
practices change from listing a brand on a prescription to listing a 
manufacturer or material, the Commission will reevaluate its decision.
---------------------------------------------------------------------------

    \437\ SNPRM, 84 FR at 24686 n.299. See also National Association 
of Optometrists and Opticians (SNPRM Comment #129) (noting as an 
example that many, if not most, prescriptions for My Day lenses 
manufactured by CooperVision get written as ``My Day,'' not as 
``CooperVision'' or ``CooperVision My Day'').
---------------------------------------------------------------------------

4. The Commission Is Not Imposing a Recordkeeping Requirement for 
Sellers Related to the Exception
    Lastly, CooperVision strongly recommended that the Commission 
reconsider its decision not to require sellers to keep records related 
to the exception and noted that the Rule relies heavily on requiring 
written evidence. CooperVision claimed that the lack of a recordkeeping 
requirement would leave a gap that could be exploited, and would make 
it difficult for the Commission to pursue enforcement against sellers 
who violate the Rule.\438\ The Commission disagrees with this 
assessment. Since the exception to alteration would be a defense for a 
seller, the seller would have the burden of proof to show it met the 
exception. Should the Commission believe that the seller has altered a 
contact lens prescription and submitted a verification request for a 
manufacturer or brand other than that indicated by a consumer, the 
seller would need evidence that it meets the exception. Sellers who 
determine not to maintain records do so at their own peril.
---------------------------------------------------------------------------

    \438\ CooperVision, Inc. (SNPRM Comment #130).
---------------------------------------------------------------------------

C. Private Label Issues

    Although most contact lenses in the United States are sold under 
national brand names (such as Acuvue Oasys, or Dailies Aquacomfort 
Plus), some manufacturers distribute their lenses to prescribers and 
retail sellers under private labels (such as Costco's Kirkland 
Signature contact lens brand or LensCrafters 1-Day Premium contact 
lenses). Private label contact lenses can be unique to one seller, or 
the private label brand may be available at multiple unaffiliated 
sellers.\439\ Despite the label, however, the lenses inside the 
packaging are exactly the same as lenses sold under a national 
brand.\440\
---------------------------------------------------------------------------

    \439\ 2005 Contact Lens Report, supra note 14, at 14-15.
    \440\ For example, Costco's Kirkland Signature Premium Daily 
Disposable lenses are the same as CooperVision MyDay disposable 
lenses.
---------------------------------------------------------------------------

1. The Commission Adopts a Technical Amendment and Clarifies That the 
Only Permissible Substitution Involves Private Label Lenses
    In Sec.  315.2, the Rule defines private label lenses as ``contact 
lenses that are sold under the label of a seller where the contact 
lenses are identical to lenses made by the same manufacturer but sold 
under the labels of other sellers.'' \441\ The Rule also provides that 
a prescription for private label contact lenses must include, in 
addition to other required information, the name of the manufacturer, 
trade name of the private label brand, and if applicable, the trade 
name of equivalent brand name.\442\ The Rule's definition for a private 
label lens prescription tracks the language of the Act.\443\
---------------------------------------------------------------------------

    \441\ 16 CFR 315.2.
    \442\ Id.
    \443\ See 15 U.S.C. 7610(3)(H).
---------------------------------------------------------------------------

    With respect to how sellers treat and substitute private label 
lenses, however, the Commission recognized in the NPRM that the 
construction of Sec.  315.5(e) of the Rule does not presently conform 
to the language or intent of the Act.\444\ The clear language of the 
Act allows sellers to substitute national brand name lenses for private 
label lenses, and vice versa, so long as it is ``the same contact lens 
manufactured by the same company and sold under multiple labels to 
individual providers.'' \445\ The Rule, meanwhile, states that a seller 
may ``substitute for private label contact lenses specified on a 
prescription identical contact lenses that the same company 
manufactures and sells under different labels.'' \446\ The different 
language of the Act thus allows sellers to substitute brand names for 
identical private labels, and private labels for identical brand names, 
while the Rule, as currently drafted, could be read to proscribe the 
latter.
---------------------------------------------------------------------------

    \444\ NPRM, 81 FR at 88552.
    \445\ 15 U.S.C. 7603(f). Although the Commission imagines it 
would be quite rare, it believes a seller should be permitted under 
the Rule to substitute one private label lens for another private 
label lens so long as the lenses are identical.
    \446\ 16 CFR 315.5(e).
---------------------------------------------------------------------------

    To conform the Rule to the Act, the Commission proposed in the NPRM 
to strike the words ``private label'' from Sec.  315.5(e), so it would 
state that a seller may ``substitute for contact lenses specified on a 
prescription identical contact lenses that the same company 
manufactures and sells under different labels.'' \447\ The Rule's 
definitions of a ``contact lens prescription'' and of a ``private label 
contact lens'' would remain unchanged. The Commission made this 
proposal after becoming aware that, in addition to prescribers, some 
other sellers (such as Costco) now market and sell private label 
contact lenses that are identical to, and are made by the same 
manufacturer as, brand name contact lenses. As a result, when a patient 
presents a contact lens prescription for brand name contact lenses to 
certain sellers, those sellers may wish to sell, as a substitute, their 
own private label lenses to the patient.
---------------------------------------------------------------------------

    \447\ NPRM, 81 FR at 88552.
---------------------------------------------------------------------------

    While the Commission's proposal was intended to clarify the Rule 
and align it with the Act's intent, some commenters opposed the change 
because they believed it could be interpreted as allowing substitution 
beyond that of private label lenses.\448\ According to Johnson & 
Johnson Vision Care, the

[[Page 50701]]

``private label'' modifier is necessary to provide guidance that the 
only instance in which a seller can lawfully substitute lenses for 
those written on a prescription is for identical private label lenses, 
and that removing the words ``private label'' from the command section 
of the Rule (leaving it only in the definitions section), will render 
the term meaningless.\449\ The removal of this term is especially 
problematic, according to the manufacturer, because illegal 
substitution is a problem in the marketplace, and it could ultimately 
cause undue, avoidable harm to patient eye health and vision 
safety.\450\ Should the Commission choose to proceed with its removal 
of the term ``private label'' from Sec.  315.5(e), Johnson & Johnson 
Vision Care requested that the Commission explicitly clarify that such 
removal does not allow for substitution beyond the scope of private 
label lenses or identical contact lenses that the same company 
manufactures and sells under different labels. It further suggested 
that the most appropriate and effective place to clarify how the 
Commission interprets this Rule provision would be in the preamble of 
the Rule, rather than the regulatory language itself.\451\
---------------------------------------------------------------------------

    \448\ Johnson & Johnson Vision Care, Inc. (NPRM Comment #4327); 
see also Tesinsky (NPRM Comment #4012) (fearing change may be 
interpreted as the ``ability to substitute a different contact by 
the same manufacturer (for example substituting Acuvue Oasys for 
Acuvue Vita), rather than just a private label substitute'').
    \449\ Johnson & Johnson Vision Care, Inc. (NPRM Comment #4327); 
see also American Optometric Association (NPRM Comment #3830) 
(opposing Commission's proposal and finding the term ``private 
label'' provides necessary clarity to ensure inappropriate 
substitutions do not occur).
    \450\ Johnson & Johnson Vision Care, Inc. (NPRM Comment #4327).
    \451\ Johnson & Johnson Vision Care, Inc. also supported its 
position that the clarification should be made in the preamble by 
reference to the fact that there were not specific reports of 
sellers encountering issues with the original Rule language. NPRM 
Comment #4327.
---------------------------------------------------------------------------

    Costco, in contrast, supported the Commission's proposed change, 
because it would make clear that sellers can substitute their own 
private label contact lenses for prescribed lenses that are identical 
to lenses made by the same manufacturer and sold under the 
manufacturer's brand.\452\ Although Costco believes that the existing 
Rule allows it, when presented with a valid prescription for the 
manufacturer's brand, to substitute Kirkland Signature lenses, it 
believed that modifications to the language of Sec.  315.5(e) would 
clarify and eliminate any doubt about the lawfulness of this practice. 
Costco also opined that without such a change, the legality of such 
substitution might be in question, and, as a result, some sellers, 
particularly those without an established relationship with 
prescribers, would likely be unwilling to invest in a private label 
lens line.\453\ Consumers Union also supported the change, indicating 
that it increases the choices available to consumers, including 
potentially more affordable options, without in any way undermining 
patient safety.\454\
---------------------------------------------------------------------------

    \452\ Costco Wholesale Corporation (NPRM Comment #4281).
    \453\ Id. Costco also commented that bringing a private label 
lens to market can significantly benefit consumers in terms of 
introducing lower prices. NPRM Comment #4281.
    \454\ Consumers Union (NPRM Comment #3969).
---------------------------------------------------------------------------

    The Commission did not intend for the removal of the words 
``private label'' in the Rule to make substitution more widely 
permissible beyond that of a seller being able to provide a private 
label lens when the identical lens (made by the same manufacturer but 
sold under a different label) is written on the prescription. However, 
in order to allay concerns, the Commission has retained the term 
``private label,'' but reordered the provision to clarify that 
permissible substitution only involves private label contact lenses. 
Thus, the Final Rule allows private label and brand name lenses, when 
they are identical lenses made by the same manufacturer listed on the 
prescription, to be substituted for each other.\455\
---------------------------------------------------------------------------

    \455\ Section 315.5(f) of the Final Rule reads: 
``Notwithstanding the preceding sentences, for private label contact 
lenses, a seller may substitute for contact lenses specified on a 
prescription identical contact lenses that the same company 
manufactures and sells under different labels.'' The Commission 
revised the provision to refer to the ``preceding sentences'' to 
make it clear that the phrase beginning with ``[n]otwithstanding'' 
does not apply to anything other than Sec.  315.5(f).
---------------------------------------------------------------------------

2. The Commission Is Not Imposing Additional Requirements on 
Prescriptions for Private Label Lenses
    As mentioned above, the Act and the Rule require prescriptions for 
private label contact lenses to include ``the name of the manufacturer, 
trade name of the private label brand, and if applicable, trade name of 
equivalent brand name.'' \456\ LD Vision Group (LensDiscounters.com), 
in response to the NPRM, provided the Commission with instances of 
alleged rule violations involving private label prescriptions 
improperly written or written without equivalents.\457\ It also 
requested that the Commission reconsider LD Vision Group's previous 
recommendations to: (1) Require prescribers to annotate private label 
lens prescriptions with the brand-name equivalent and if the name-brand 
equivalent is unavailable, the private-label prescription must be 
medically necessary for that particular patient; (2) require 
manufacturers of contact lenses to make brand information available to 
all sellers, consumers, and the FTC; or (3) require manufacturers and 
sellers to make brand equivalency information available and easily 
accessible for private labels on their brand label packaging and 
online.
---------------------------------------------------------------------------

    \456\ 15 U.S.C. 7610; 16 CFR 315.2 (in definition of contact 
lens prescription).
    \457\ This commenter also disagreed with what it stated was the 
``Commission's diminishment of private label concerns.'' LD Vision 
Group, Inc. (NPRM Comment #3958).
---------------------------------------------------------------------------

    Although the Commission appreciates the additional information 
provided by LD Vision Group, the information has not altered the fact, 
as stated in the SNPRM, that the Act does not impose a requirement of 
medical necessity in order for a prescriber to prescribe a private 
label lens for which no name-brand equivalent exists.\458\ The Act also 
does not expressly contemplate the imposition of disclosure 
requirements on manufacturers. Therefore, the Commission is not 
implementing the recommendations of LD Vision Group.
---------------------------------------------------------------------------

    \458\ SNPRM, 81 FR 88551. In the SNPRM, the Commission also 
referenced the initial rulemaking, where sellers recommended that 
prescribers be required, when prescribing private label contact 
lenses, to identify on the prescription the name of a brand that a 
consumer could purchase from a seller other than the prescribing 
office. 69 FR 40503. The Act does not limit, in any way, the brand 
that a prescriber must select, and the current record does not have 
sufficient evidence indicating that this is a problem. Id. 
Therefore, LD Vision Group's proposal to limit prescribers from 
prescribing private label brands without a brand-equivalent is not 
adopted.
---------------------------------------------------------------------------

    The Act and the Rule expressly require that, for private label 
contact lens prescriptions, prescribers include ``trade name of 
equivalent brand name.'' \459\ Prescribers violate the Rule if they 
provide a script that omits this information because the script does 
not meet the definition of a contact lens prescription. With that in 
mind and given the additional information provided by LD Vision Group, 
the Commission will consider whether enforcement action is appropriate.
---------------------------------------------------------------------------

    \459\ 15 U.S.C. 7610, 16 CFR 315.2 (contact lens prescription 
defined to include, in the case of a private label contact lens, the 
name of the manufacturer, trade name of the private label brand, 
and, if applicable, trade name of equivalent brand name).
---------------------------------------------------------------------------

VII. ``Directly or by Facsimile'' Language Includes Use of Online 
Patient Portals to Present Prescriptions

    Section 315.5(a)(1) of the Rule provides that a seller may sell 
contact lenses in accordance with a prescription that is presented to 
the seller ``directly or by facsimile.'' In the NPRM, the Commission 
initially determined that the provision ``directly or by facsimile'' 
includes the use of online patient portals by patients and prescribers 
to present contact lens prescriptions to

[[Page 50702]]

sellers.\460\ The Commission noted that use of a patient portal 
``necessarily involves `an exact copy of the prescription within the 
scope of acceptable direct presentation mechanisms.' '' \461\ The 
Commission observed in the NPRM that technology had evolved since the 
Rule's implementation in 2004 and that patient portals offered several 
potential benefits, including reducing: The chance of an inaccurate or 
expired prescription being presented to a seller; the costs for 
prescribers, patients, and sellers by making it easier and more 
efficient for patients to share and present prescriptions; and the 
number of verification requests to prescribers.\462\ The Commission 
sought comments on whether the use of online portals complies with the 
Rule and requested information about whether the Commission should 
consider any other issues related to the presentation of prescriptions 
to sellers.
---------------------------------------------------------------------------

    \460\ NPRM, 81 FR at 88537-38.
    \461\ Id. at 88538.
    \462\ Id.
---------------------------------------------------------------------------

    Although the Commission received many comments indicating that 
patients are able to receive their prescriptions electronically, 
including through patient portals, and interact with their prescribers 
electronically,\463\ few comments addressed the use of portals to 
present prescriptions directly to sellers. Commenters agreed that such 
technology could offer benefits, including reducing the number of 
requests for verification and additional copies, and giving patients 
greater access to their prescriptions.\464\ However, it is unclear how 
often, if at all, prescribers send prescriptions to sellers through a 
portal. Use of portals to transmit prescriptions to sellers could face 
barriers, including technology issues between the parties caused by 
using different software and platforms, and privacy restrictions 
preventing sellers from accessing patients' portal accounts.\465\
---------------------------------------------------------------------------

    \463\ See, e.g., Eklund (WS Comment #502); Reed (WS Comment 
#749); Gitchell (WS Comment #759); Andrews (WS Comment #1014); 
Carvell (WS Comment #1021); Cecil (WS Comment #1892); Kuryan (WS 
Comment #3472); Hopkins (NPRM Comment #184); Wilson (NPRM Comment 
#1310); Grove (NPRM Comment #1702); MacDonald (NPRM Comment #2118); 
Andrus (NPRM Comment #3345); American Academy of Ophthalmology (NPRM 
Comment #3657) (``For practices that utilize electronic medical 
record systems, patients can request a copy of their prescription 
and [be] issued one electronically.''); Coalition for Contact Lens 
Consumer Choice (SNPRM Comment #89).
    \464\ National Association of Optometrists and Opticians (NPRM 
Comment #3851) (noting that the option to provide a prescription 
through a portal should be available because technology will 
continue to advance); 1-800 CONTACTS (NPRM Comment #3898); Costco 
Wholesale Corp. (NPRM Comment #4281) (supporting the FTC's 
determination regarding presentation of prescriptions directly or by 
facsimile for the reasons cited in the NPRM); NPRM, 81 FR at 88538 
(identifying the potential benefits of using a portal to present a 
prescription to a seller). Other commenters have expressed the 
potential benefits of portals or electronic health records 
generally. See, e.g., Information Technology & Innovation Foundation 
(SNPRM Comment #103); Opticians Association of Americas (WS Comment 
#482); Marshall (WS Comment #518) (suggesting the benefit of 
electronic medical records in allowing easier access to the 
prescription); McCarty (WS Comment #1898); CooperVision, Inc. (WS 
Comment #3077); Coalition for Contact Lens Consumer Choice (WS 
Comment #3239) (stating that new technologies like electronic health 
records have benefits for consumers).
    \465\ Hill (WS Comment #1361); McCarty (WS Comment #1898); Shum 
(WS Comment #543) (stating that ``[t]he use of patient portals to 
send Rx would be unreliable due to inconsistent EHR [(electronic 
health records)] software and that some doctors do not have EHR''); 
National Hispanic Medical Association (SNPRM Comment #146) (stating 
that creating a portal to share prescription information could be a 
burden on prescribers and patients); 1-800 CONTACTS (NPRM Comment 
#3898) (stating that ``to the extent prescribers use portals to 
provide sellers with prescriptions, their portal should have the 
ability to send the prescription to the seller directly by email, 
text, or facsimile, and a seller should not be required to develop 
direct communication links to the portal''); CLR Panel V Tr., supra 
note 191, at 19-20.
---------------------------------------------------------------------------

    The Act and Rule clearly envision and support the use of electronic 
means to provide prescriptions. Section 7601(a)(2) of the Act requires 
prescribers to ``provide or verify the contact lens prescription by 
electronic or other means'' to patients' agents.\466\ As discussed in 
the NPRM, it would be inconsistent for the Rule to permit prescribers 
to provide prescriptions electronically to patients, but not allow 
prescribers to provide a prescription electronically to a seller.\467\
---------------------------------------------------------------------------

    \466\ 15 U.S.C. 7601(a)(2); 16 CFR 315.3(a)(2).
    \467\ NPRM, 81 FR at 88538.
---------------------------------------------------------------------------

    Use of electronic medical records has increased in the health field 
generally,\468\ and many prescribers already use electronic methods to 
communicate with patients, including through patient portals.\469\ 
Given the potential benefits, prescribers and patients should have the 
option to present a prescription to sellers through a patient portal 
when this method is available. Therefore, the Commission affirms its 
initial determination that the ``directly or by facsimile'' language 
includes the use of online patient portals by patients and prescribers 
to present contact lens prescriptions to sellers.
---------------------------------------------------------------------------

    \468\ One survey from 2017 found that 52% of individuals were 
offered online access to their medical records by a health provider 
or insurer, an increase from 42% in 2014. Of those patients who were 
offered online access, more than half actually viewed their online 
medical records at least once in the past year. U.S. Dep't of Health 
& Human Servs., The Office of the National Coordinator for Health 
Information Technology, ``Individuals' Use of Online Medical Records 
& Technology for Health Needs'' 1-2 (2018). Furthermore, in 2013, 
57% of prescriptions nationally were sent electronically from 
physicians to pharmacies, with the rate in some states over 80%. 
U.S. Dep't of Health & Human Servs., The Office of the National 
Coordinator for Health Information Technology, ``E-Prescribing 
Trends in the United States'' 8 (2014).
    \469\ American Optometric Association (SNPRM Comment #96) 
(stating that approximately 47.5% of optometrists used electronic 
health records with a patient portal in their practice); National 
Association of Optometrists and Opticians (SNPRM Comment #129) 
(``Practice management systems and electronic health records (EHRs) 
with the capacity to allow patient portals, email, and text 
communication are easily available at reasonable prices to 
optometrists . . . .''); National Hispanic Medical Association 
(SNPRM Comment #146); 1-800 CONTACTS (NPRM Comment #3898). But see 
CLR Panel V Tr., supra note 191, at 17 (comment by a panelist that 
only 8% of his office's patients used the portal).
---------------------------------------------------------------------------

VIII. Requests for an Additional Copy of a Prescription

    In the SNPRM, the Commission proposed requiring that prescribers 
who receive requests for additional copies of prescriptions from 
patients or their agents respond within forty business hours.\470\ The 
Commission believed that the forty-business-hour requirement was 
necessary to ensure that patients or their agents could receive 
additional copies of their prescription in a timely manner while 
recognizing that a shorter time period was unnecessary because patients 
would have already received a copy of their prescription after the 
contact lens fittings were completed and sellers could always submit a 
verification request.\471\ Additionally, prescribers would be required 
to note in the patient's file the name of the requester and the date 
and time the prescription was provided. The Commission sought comment 
on whether prescribers should be required to respond within a certain 
time period, whether forty business hours was the appropriate time 
period, and what records, if any, prescribers should be required to 
keep to document the request and response.\472\
---------------------------------------------------------------------------

    \470\ SNPRM, 84 FR at 24684.
    \471\ Id.
    \472\ Id.
---------------------------------------------------------------------------

A. Benefits of an Additional Copy and the Time Period To Respond to a 
Request

    The AOA contends that Congress did not intend for sellers to be 
given authorization to serve as the patient's agent.\473\ Rather, the 
AOA ``assume[s] that Congress implemented this provision to account for 
cases in which a family member or caregiver needed authorization to 
obtain a patient's

[[Page 50703]]

prescription.'' \474\ As noted in the NPRM, the Commission relied on 
the plain language of the Act and Rule to determine that sellers could 
serve as agents for patients,\475\ and the AOA does not point to any 
contrary evidence.\476\ Additionally, the AOA believes that no deadline 
to respond to requests for additional copies is necessary because 
prescribers take their responsibilities to their patients 
seriously.\477\
---------------------------------------------------------------------------

    \473\ American Optometric Association (SNPRM Comment #96).
    \474\ Id.
    \475\ NPRM, 81 FR at 88536. In addition to sellers, the SNPRM 
noted that patients themselves could request an additional copy of 
the prescription. Although a commenter requested that the Commission 
modify the Rule to clarify that patients can request their own 
additional copy (National Association of Optometrists and Opticians 
(SNPRM Comment #129)), the Commission believes that the Rule's 
language is sufficient and declines to make such change. SNPRM, 84 
FR at 24684 n.259.
    \476\ American Optometric Association (SNPRM Comment #96).
    \477\ Id. The AOA also urged the Commission not to rely on 1-800 
CONTACTS data indicating that only 46% of its requests for an 
additional copy of a prescription received a response because 1-800 
CONTACTS may not have the patients' consent to act as an agent. 
Although the Commission considered the 1-800 CONTACTS data, the 
Commission did not rely solely on this information when issuing its 
proposed Rule. SNPRM, 84 FR at 24669.
---------------------------------------------------------------------------

    Other commenters supported the Commission's proposal regarding 
requests for additional copies.\478\ Commenters noted that a deadline 
to respond would: (1) Make the process more predictable for patients 
and sellers, especially when involving a prescriber who has not 
responded to such requests in the past; \479\ (2) potentially reduce 
the number of verification requests, which would benefit prescribers, 
sellers, and patients; and (3) improve the accuracy of information 
provided to sellers ensuring that patients receive the correct 
lenses.\480\ In addition to anecdotal accounts of prescribers not 
responding to requests for additional copies, 1-800 CONTACTS commented 
that, in 2019 to date, it had received a response to approximately 52% 
of its requests for an additional copy with 82% of the responses being 
received within forty-eight hours of the request.\481\ This 2019 data 
is similar to 1-800 CONTACTS' 2016 data, which showed that 46% of the 
requests received a response and 90% of those responses were received 
within two days.\482\ In response, the AOA questions 1-800 CONTACTS' 
2016 data because patients, who gave consent through a prechecked box, 
may not have intended for 1-800 CONTACTS to act as their agent in 
requesting the prescription.\483\ The AOA posits that prescriber 
concern over patients' consent ``may have impacted responses to [1-800 
CONTACTS'] requests,'' but offers no evidence to support this 
argument.\484\ Likewise, the AOA did not provide any data showing the 
extent to which prescribers have responded to requests for additional 
copies. Given the potential benefits and the aforementioned data, the 
Commission does not believe it is sufficient to rely simply on the 
expectation that all prescribers would fulfill their responsibilities 
to their patients. Rather, the Commission believes that the Rule should 
be amended to add a deadline to respond to a request for an additional 
copy.
---------------------------------------------------------------------------

    \478\ Citizen Outreach (SNPRM Comment #78); Lens.com (SNPRM 
Comment #85); Coalition for Contact Lens Consumer Choice (SNPRM 
Comment #89); Consumer Action (SNPRM Comment #101); Information 
Technology and Innovation Foundation (SNPRM Comment #103); National 
Association of Optometrists and Opticians (SNPRM Comment #129); 
Consumer Reports (SNPRM Comment #133); 1-800 CONTACTS (SNPRM Comment 
#135); American Academy of Ophthalmology (SNPRM Comment #136); 
Attorneys General of 27 States (SNPRM Comment #139).
    \479\ Although not always the case, some sellers expressed 
difficulties with obtaining responses from prescribers. See National 
Association of Optometrists and Opticians (SNPRM Comment #129) 
(stating that at least one NAOO member reported receiving timely 
responses while other members found that it was ``difficult, if not 
impossible, to get any form of a timely response'').
    \480\ Coalition for Contact Lens Consumer Choice (SNPRM Comment 
#89); National Association of Optometrists and Opticians (SNPRM 
Comment #129); Consumer Reports (SNPRM Comment #133); 1-800 CONTACTS 
(SNPRM Comment #135); Attorneys General of 27 States (SNPRM Comment 
#139); Contact Lens Association of Ophthalmologists (NPRM Comment 
#4259).
    \481\ 1-800 CONTACTS (SNPRM Comment #135).
    \482\ 1-800 CONTACTS (NPRM Comment #3898).
    \483\ American Optometric Association (SNPRM Comment #96).
    \484\ Id.
---------------------------------------------------------------------------

    Although some commenters agreed that the Commission's proposed 
deadline of forty business hours was a reasonable length of time,\485\ 
other commenters urged the Commission to use a shorter period, such as 
one business day \486\ or twenty-four business hours,\487\ because (1) 
patients would want a quicker response, (2) the longer time period 
could undercut a benefit of using a prescription--reducing the number 
of verification requests, and (3) prescribers could be confused between 
forty business hours for an additional copy request and eight business 
hours for a verification request.\488\ Additionally, the work involved 
for a prescriber's office to respond to a request would not increase 
with a shorter deadline.\489\ Although patients would benefit from a 
shorter response period, the Commission recognizes the additional 
stress on prescribers of having less time to respond, even if the work 
involved to complete a response remains the same. Because patients 
should have already received a copy of their prescription after the 
fitting,\490\ sellers can submit a verification request to complete the 
sale more quickly,\491\ and prescribers have an obligation to respond 
to a request for an additional copy, unlike a verification request, the 
Commission declines to make any further changes and will adopt the 
proposed forty-business-hour period.
---------------------------------------------------------------------------

    \485\ Coalition for Contact Lens Consumer Choice (SNPRM Comment 
#89); American Optometric Association (SNPRM Comment #96) (noting 
that if a deadline were added, forty business hours would be 
reasonable); Information Technology and Innovation Foundation (SNPRM 
Comment #103); 1-800 CONTACTS (SNPRM Comment #135); American Academy 
of Ophthalmology (SNPRM Comment #136).
    \486\ Consumer Reports (SNPRM Comment #133).
    \487\ National Association of Optometrists and Opticians (SNPRM 
Comment #129) (supporting a shorter time limit, in part, because the 
burden of complying could be lower due to portal, text, or email 
use).
    \488\ National Association of Optometrists and Opticians (SNPRM 
Comment #129); Consumer Reports (SNPRM Comment #133).
    \489\ Consumer Reports (SNPRM Comment #133).
    \490\ 16 CFR 315.3(a)(1).
    \491\ 16 CFR 315.5(a)(2).
---------------------------------------------------------------------------

B. Requirement To Maintain Records

    Finally, as to what records, if any, a prescriber should be 
required to maintain regarding the request for an additional copy, the 
AOA believes that sellers, not prescribers, should shoulder this burden 
because sellers are ``leveraging the patient agent provision to obtain 
patient prescriptions.'' \492\ Records of the request and the response 
would allow the Commission to monitor compliance.\493\ However, the 
Commission does not believe requiring the requestor to maintain such 
information would be appropriate because the obligation under the Rule 
to respond to prescription requests rests with prescribers and they 
would be in the best position to maintain records.\494\ Importantly, 
the Rule allows ``any person designated to act on behalf of the 
patient[,]'' including the patients themselves, family members, or 
caregivers, to request a copy of a prescription, not just sellers.\495\ 
A shift of the recordkeeping burden to any

[[Page 50704]]

designated agent making a request would not allow for effective 
monitoring because the Commission might need to obtain records from a 
wide variety of agents in order to determine whether a particular 
prescriber is complying with the Rule. Thus, the Commission declines to 
change the recordkeeping requirement.
---------------------------------------------------------------------------

    \492\ American Optometric Association (SNPRM Comment #96).
    \493\ The proposed Rule would mandate that prescribers make 
notations of the required information in their records, but would 
not require that they keep specific documentation. SNPRM, 84 FR at 
24698. However, prescribers could choose to keep documentation of 
the request and response if they preferred.
    \494\ See also National Association of Optometrists and 
Opticians (SNPRM Comment #129) (``We believe it will be straight-
forward and simple for the prescriber to keep a record of receiving 
the request for a copy and noting how and when the prescriber 
responded.'').
    \495\ SNPRM, 84 FR at 24684 n.259, 24698.
---------------------------------------------------------------------------

    In conclusion, the Commission adopts the changes proposed in the 
SNPRM to require that prescribers respond to requests for an additional 
copy of a prescription within forty business hours and note in the 
patient's record the name of the requestor and the date and time that 
the prescription was provided in response.

IX. Excessive Quantity

    In the NPRM, the Commission declined to make any changes regarding 
the number of lenses that a consumer can purchase with a 
prescription.\496\ Several commenters had expressed concerns that 
consumers were able to obtain more than a year's supply of contact 
lenses, often by purchasing more than a year's worth at one time or by 
refilling their prescription just before the expiration date.\497\ 
However, the Commission determined that there was insufficient evidence 
on the record to support a limit on the maximum quantity of lenses that 
consumers can purchase prior to the prescription's expiration.\498\ 
Although there was some evidence that patients purchased contact lenses 
just before their prescriptions expired, this evidence did not show 
that the quantity of lenses being purchased was excessive or that 
consumers were skipping eye exams.\499\ Furthermore, the Commission 
believed that a maximum quantity limit would be difficult to administer 
and could have a more significant negative effect on consumers who, 
instead of following the recommended replacement schedule, opt to wear 
their lenses longer until they see a prescriber.\500\
---------------------------------------------------------------------------

    \496\ NPRM, 81 FR at 88549.
    \497\ Id. at 88547-48.
    \498\ Id. at 88548-49. The Commission also declined to modify 
the Rule to state that contact lens prescriptions are valid for an 
unlimited quantity of lenses regardless of any prescriber-imposed 
limitation. The Commission found no evidence that prescribers were 
using quantity limits to undercut the prescription length and 
recognized that some state laws or regulations mandated that 
quantity information be included on a prescription, or that a 
prescriber may choose to do so. NPRM, 81 FR at 88549-50. However, 
prescribers cannot use quantity limits as a way to frustrate the 
Rule's prescription expiration requirements. Id. at 88550.
    \499\ Id.
    \500\ Id.
---------------------------------------------------------------------------

    In response to the NPRM, some commenters supported the Commission's 
decision not to impose quantity limits \501\ while others expressed 
concerns about the purchase of excessive quantities and advocated for 
limits.\502\ The commenters who support quantity limits are concerned 
that patients who purchase excessive quantities of lenses face 
increased health risks because they do not see their prescriber as 
often.\503\ Contrary to the Commission's position in the NPRM, they 
believe that there is evidence in the record that consumers are 
purchasing an excessive number of lenses close to the end of their 
prescription and that a quantity limit can be implemented.\504\ These 
commenters point to survey evidence by Johnson & Johnson Vision Care 
showing that consumers, in response to reminders that their 
prescriptions would be expiring soon, ordered more lenses.\505\
---------------------------------------------------------------------------

    \501\ Coalition for Contact Lens Consumer Choice (NPRM Comment 
#3718); Consumer Action (NPRM Comment #3721); 1-800 CONTACTS (NPRM 
Comment #3898).
    \502\ See, e.g., Contact Lens Institute (SNPRM Comment #79); 
Goodman (WS Comment 599); Hanen (WS Comment #712); Dillehay (WS 
Comment #822); Rosenblatt (WS Comment #841); Hooven (WS Comment 
#1366); Henry (WS Comment #2194); Robson (WS Comment #2210); 
Wiechmann (WS Comment #2823); Health Alliance for Patient Safety (WS 
Comment #3206); Alcon Laboratories, Inc. (WS Comment #3339); 
Ellenbecker (WS Comment #3353); Jeun (NPRM Comment #1774); Daza 
(NPRM Comment #2002); Silva (NPRM Comment #3072); CooperVision, Inc. 
(NPRM Comment #3841); Coalition for Patient Vision Care Safety (NPRM 
Comment #3883); see CLR Panel IV Tr., supra note 121, at 19 
(statement of David Cockrell).
    \503\ Jeun (NPRM Comment #1774); Daza (NPRM Comment #2002); 
CooperVision, Inc. (NPRM Comment #3841); Coalition for Patient 
Vision Care Safety (NPRM Comment #3883).
    \504\ CooperVision, Inc. (NPRM Comment #3841); Coalition for 
Patient Vision Care Safety (NPRM Comment #3883).
    \505\ CooperVision, Inc. (NPRM Comment #3841) (stating that 
evidence of the high number of patients being contacted in the last 
days of their prescription ``provides a powerful inference that 
sales in many situations are excessive''); Coalition for Patient 
Vision Care Safety (NPRM Comment #3883).
---------------------------------------------------------------------------

    However, the concern is not whether consumers are purchasing lenses 
near the end of their prescription, but whether they are purchasing 
excessive quantities. As noted in the NPRM, the Johnson & Johnson 
Vision Care survey did not ask about the quantity of lenses purchased 
by consumers.\506\ The Commission had previously found that consumers 
typically do not purchase a year's supply of lenses at one time.\507\ 
Additionally, 1-800 CONTACTS stated that it was aware of survey 
evidence it believed showed that six months is the average size of an 
order made during the last thirty days of a prescription, which is 
similar to, based on 1-800 CONTACTS internal data, the average quantity 
ordered throughout the duration of the prescription.\508\ Thus, the 
Commission does not have sufficient basis to conclude, despite 
anecdotal reports and alleged practices by some sellers, that consumers 
are purchasing lenses in excessive quantities near the end of their 
prescription.\509\ Neither does the Commission have sufficient evidence 
showing that consumers are going to eye care providers less frequently 
because they previously purchased large quantities of contact lenses. 
In fact, evidence suggests that a majority of consumers are seeing 
their eye care provider regularly. One survey found that contact lens 
wearers have an eye exam every thirteen months on average while another 
survey showed that about 56% of respondents received an eye exam every 
twelve months or less, with an overall average of approximately sixteen 
months.\510\ These surveys appear consistent with a prior survey by the 
Coalition for Patient Vision Care Safety, which found that 87% of 
contact lens wearers had an eye exam last year.\511\
---------------------------------------------------------------------------

    \506\ NPRM, 81 FR at 88549-50; see also Johnson & Johnson Vision 
Care, Inc. (RFC Comment #582) (asking consumers whether a seller 
notified them that their prescription was expiring and whether they 
have ever ordered lenses within a month of their prescription's 
expiration).
    \507\ NPRM, 81 FR at 88549.
    \508\ 1-800 CONTACTS (NPRM Comment #3898) (stating that for a 
monthly contact lens the standard package size is six months, which 
is the minimum quantity available).
    \509\ NPRM, 81 FR at 88549.
    \510\ 1-800 CONTACTS (NPRM Comment #3898).
    \511\ NPRM, 81 FR at 88549 n.308.
---------------------------------------------------------------------------

    Some commenters also believe that a quantity limitation would not 
be difficult to implement when the seller has the prescription because 
sales could be limited to the amount of lenses necessary for the 
remaining period of the prescription or based on typical usage.\512\ 
However, it would be impractical for sellers to determine whether the 
quantity of lenses being purchased is necessary or typical because such 
amounts may not be the same for all consumers. Additionally, as noted 
in the NPRM, there are legitimate reasons why a consumer may want to 
purchase a supply of lenses that exceeds the remaining period of the

[[Page 50705]]

prescription, including having enough lenses until the next scheduled 
appointment, having replacements for lost or torn lenses, or replacing 
lenses more frequently.\513\ Additionally, quantity limitations could 
encourage some consumers to stretch out their lens supply by wearing 
them longer than recommended, which is a well-documented health issue 
that outweighs the potential harm of patients purchasing a quantity of 
lenses that exceeds what is strictly anticipated by the remaining 
length of the prescription.\514\ Although it is possible that patients 
could purchase large quantities of lenses by presenting their 
prescription to multiple sellers, the Commission does not have evidence 
about the extent of such practice.\515\ Finally, when verification is 
used, a prescriber can determine whether the quantity ordered is 
excessive, and, if it is, inform the seller within the eight-business-
hour period that the request is inaccurate and specify the appropriate 
amount of lenses.\516\ In conclusion, the Commission declines to modify 
the Rule to limit the quantity of lenses that consumers can purchase.
---------------------------------------------------------------------------

    \512\ Contact Lens Institute (SNPRM Comment #79) (stating that 
the ``health and safety of patients requires limits on the sale of 
quantities of contact lenses beyond those reasonably required for 
patient use during the remaining term of a prescription'' and urging 
that a verification request for a prescription that is close to 
expiration be treated as an alteration because it seeks to dispense 
excessive quantities of lenses); Coalition for Patient Vision Care 
Safety (NPRM Comment #3883) (stating that ``when the seller has the 
prescription, no sale should exceed a supply of lenses necessary to 
last the remaining period of the prescription''); CooperVision, Inc. 
(NPRM Comment #3841).
    \513\ NPRM, 81 FR at 88549; 1-800 CONTACTS (NPRM Comment #3898).
    \514\ NPRM, 81 FR at 88549. See also 1-800 CONTACTS (NPRM 
Comment #3898) (citing survey data showing that 65% of participants 
tended to wear their last pair of contact lenses longer than when 
they have a supply of lenses).
    \515\ NPRM, 81 FR at 88550.
    \516\ 16 CFR 315.5(d); Contact Lens Rule, 69 FR at 40501; NPRM, 
81 FR at 88550 n.313.
---------------------------------------------------------------------------

X. Expiration of Contact Lens Prescriptions

    Section 315.6(a) of the Rule requires that a prescription expire on 
the date specified by the law of the state in which the prescription 
was written, if that date is one year or more after the issue date of 
the prescription.\517\ The Rule also provides that a prescription shall 
not expire less than one year after the issue date of the prescription, 
unless the prescriber specifies a shorter period that is ``based on the 
medical judgment of the prescriber with respect to the ocular health of 
the patient'' and documents the reasoning for the shorter expiration 
period in the patient's medical record.\518\
---------------------------------------------------------------------------

    \517\ 16 CFR 315.6(a)(1).
    \518\ 16 CFR 315.6(a)(2)-(3); 16 CFR 315.6(b)(1).
---------------------------------------------------------------------------

    The NPRM addressed comments requesting that the Commission set a 
longer minimum length for prescriptions, prohibit expirations on 
certain prescriptions, or leave prescription length to the sole 
discretion of the provider.\519\ However, because the Rule's provisions 
closely track the Act, which sets a minimum expiration date ``to 
prevent prescribers from selecting a short expiration date . . . that 
unduly limits the ability of consumers to purchases contact lenses'' 
and because the Commission concluded that, in drafting the Act, 
Congress intended to defer to state law except where such law 
establishes a period of less than one year, the Commission stated that 
the current framework is appropriate and declined to make changes.\520\ 
The NPRM also addressed prescriber reports of patients obtaining 
contact lenses through sellers, especially online sellers, with expired 
contact lens prescriptions.\521\ Commenters requested a Rule change or 
greater enforcement of the Rule to deal with this problem.\522\ 
However, finding that the Rule sufficiently prohibited the use of 
expired prescriptions, the Commission declines to amend the Rule.\523\
---------------------------------------------------------------------------

    \519\ NPRM, 81 FR at 88546.
    \520\ Id.; see also 15 U.S.C. 7604.
    \521\ NPRM, 81 FR at 88546-47.
    \522\ Id.
    \523\ Id. at 88547.
---------------------------------------------------------------------------

A. Length of Contact Lens Prescriptions

    Following the NPRM's discussion of expiration length, the 
Commission received additional comments that favored making 
prescriptions valid for more than one year.\524\ Some commenters 
advocated for such change because they believed that prescriptions 
rarely change \525\ or that consumers would save money if they needed 
to obtain exams less often.\526\ Other commenters expressed concern 
that shorter prescription expirations may have the undesirable result 
of encouraging consumers to wear contacts for longer than recommended 
\527\ or that there should not be a standard minimum expiration in the 
Rule due to variations in patient needs.\528\
---------------------------------------------------------------------------

    \524\ Radcliffe (WS Comment #2); Williams (WS Comment #1036); 
Yenovkian (WS Comment #1362); Yuen (NPRM Comment #1854); Susswein 
(NPRM Comment #3759).
    \525\ Radcliffe (WS Comment #2); Williams (WS Comment #1036).
    \526\ Williams (WS Comment #1036); Yuen (NPRM Comment #1854).
    \527\ Berenguer (WS Comment #111).
    \528\ Moss (WS Comment #837).
---------------------------------------------------------------------------

    However, some manufacturer and prescriber organizations favored 
maintaining the Rule's current expiration provisions. Johnson & Johnson 
Vision Care stated that the current Rule ``ensures that patients 
continue to receive the vital professional oversight to decrease 
avoidable risks and increases patient access to the latest technologies 
to best meet their vision care needs.'' \529\ Likewise, the AOA and the 
Contact Lens Institute supported the Commission maintaining the Rule's 
current prescription length provisions.\530\
---------------------------------------------------------------------------

    \529\ Johnson & Johnson Vision Care, Inc. (NPRM Comment #4327). 
Peter Menziuso, President of JJVCI, also echoed this sentiment at 
the workshop, stating that the company feels strongly about 
maintaining the one-year expiration to assure patients are seeing 
their prescriber regularly and prioritizing health. See CLR Panel IV 
Tr., supra note 121, at 16.
    \530\ Contact Lens Institute (SNPRM Comment #79); American 
Optometric Association (NPRM Comment #3830).
---------------------------------------------------------------------------

    After reviewing the comments, the Commission again declines to 
modify or remove the Rule's prescription length provisions. The current 
Rule closely tracks the Act, which Congress mandated, and already 
contains provisions that allow for prescriptions longer than one year, 
dependent upon state law, and shorter than one year, when those are 
appropriate based on the medical judgment of the prescriber, ensuring 
flexibility.\531\ The Commission does not find the record adequately 
supports lengthening the Rule's prescription expiration provisions. 
Therefore, the Commission declines to alter the Rule's provisions 
relating to prescription length.
---------------------------------------------------------------------------

    \531\ 16 CFR 315.6(a)(2)-(3); 16 CFR 315.6(b)(1).
---------------------------------------------------------------------------

B. Sales Using Expired Contact Lens Prescriptions

    After the NPRM, commenters again raised the issue of sellers 
selling contact lenses past the prescription expiration dates,\532\ and 
some argued that additional regulation is needed.\533\ The Rule already 
makes clear that expired prescriptions are invalid and prohibits

[[Page 50706]]

sales with such prescriptions.\534\ If a consumer presents the seller 
with an expired prescription, the seller cannot use it as the basis for 
the sale. Not only is the seller unable to base a sale on that expired 
prescription, but as the Commission clarified in the NPRM, a seller may 
not use an expired prescription as the basis for a verification 
request.\535\ If, however, a seller is presented with a prescription 
that lacks an expiration date,\536\ and that seller does not have 
knowledge as to whether the prescription is expired, the seller must 
verify the prescription with the prescriber prior to dispensing lenses. 
In this instance, the seller may rely on the prescriber to inform the 
seller if the prescription is expired.\537\
---------------------------------------------------------------------------

    \532\ See, e.g., Hanian (SNPRM Comment #27); Pirozzolo (SNPRM 
Comment #33); Wilkes (SNPRM Comment #86); AOA (SNPRM Comment #96); 
Parikh (SNPRM Comment #152); Fuller (WS Comment #531); McBride (WS 
Comment #630); Swindell (WS Comment #682); Hamilton (WS Comment 
#781); Caywood (WS Comment #788); Matus (WS Comment #1534); Malaski 
(WS Comment #3160); DiGirolamo (NPRM Comment #23); Endry (NPRM 
Comment #29); Ross (NPRM Comment #48); Hanen-Smith (NPRM Comment 
#154); Weisz (NPRM Comment #963); Helwig (NPRM Comment #2349); 
Simpson (NPRM Comment #2896); Holle (NPRM Comment #3214); Gordon 
(NPRM Comment #3544); Reinstein (NPRM Comment #3560); Sheffer (NPRM 
Comment #3577).
    \533\ Kepley (SNPRM Comment #76); Radford (NPRM Comment #59); 
Rodriguez (NPRM Comment #3896) (``I was disappointed to learn that 
the FTC will not, under its existing authority, seek to more-fully 
address the many unscrupulous business practices of online contact 
lens sellers that have been putting the health and safety of 
patients at risk for more than a decade. Expired contact lens 
prescriptions are regularly processed and filled by these online 
business.''); Huang (NPRM Comment #2203); Avila (NPRM Comment #52); 
Hanen-Smith (NPRM Comment #154); Letter from Senator Heidi Heitkamp 
to Acting Chairwoman Maureen Ohlhausen (Jan. 5, 2018); Letter from 
Congressman Jeff Denham et al. to Chairman Joseph Simons (July 27, 
2018).
    \534\ 16 CFR 315.5(d).
    \535\ NPRM, 81 FR at 88546-47.
    \536\ 16 CFR 315.2.
    \537\ NPRM, 81 FR at 88547.
---------------------------------------------------------------------------

    CooperVision requested that the Commission require that sellers, 
when not in possession of an unexpired prescription, ask consumers if 
their prescriptions have expired.\538\ In the NPRM, the Commission 
addressed a similar request by AOA to require sellers to include the 
expiration and issue dates, both required elements of a prescription, 
in verification requests.\539\ According to the AOA, this requirement 
would incentivize sellers to make sure patients know their prescription 
expiration date. However, as explained in the NPRM, the seller would 
not necessarily have the expiration or issue dates, and neither would 
the patient.\540\ A better source for this information is the 
prescriber, who has the ability to invalidate a prescription request 
because it is expired.\541\ For this reason, the Commission will not 
implement CooperVision's proposal. Additionally, a number of prescriber 
organizations expressed concerns that consumers are able to buy lenses 
on expired prescriptions because of passive verification.\542\ Further, 
to lessen the chances of the sale of lenses after the expiration of a 
prescription, some commenters requested that the Commission require 
that prescriptions be presented at the time of the sale of lenses.\543\ 
As stated in Section V, Congress mandated passive verification, and 
requiring prescription presentation would be inconsistent with 
Congress's intent. The Final Rule also includes several changes to 
automated verification calls that will improve passive verification by 
allowing prescribers to better identify requests based on expired 
prescriptions.\544\
---------------------------------------------------------------------------

    \538\ CooperVision, Inc. (SNPRM Comment #130).
    \539\ NPRM, 81 FR at 88547 (citing AOA Comment #644).
    \540\ NPRM, 81 FR at 88547.
    \541\ As explained in the Alteration section, Section VI, supra, 
if a seller wishes to avail itself of the exception to alteration, 
it may use an expired prescription as an indication of manufacturer 
or brand if the minimum criteria discussed in that Section are met, 
and the seller obtains additional information, from the consumer or 
the prescriber, that the consumer has a current prescription for 
that brand. In so doing, the seller obtains a basis for the 
verification request other than the expired prescription.
    \542\ Contact Lens Institute (SNPRM Comment #79) (``Indeed, CLI 
remains concerned about the contribution of passive verification via 
robocalls to filling expired or invalid prescriptions . . .''); 
American Society of Cataract and Refractive Surgery (SNPRM Comment 
#127) (``Significant concerns with patient safety, as the current 
eight-hour validation window allows inaccurate, falsified, and 
expired contact lens prescriptions to be filled. Subsequently, 
patients' ocular health is put at risk because of a restricted 
validation period.''); American Society of Cataract and Refractive 
Surgery (NPRM Comment #3820) (``Many of our members practice in solo 
or small practices that often do not have the resources to respond 
to verification requests within the eight-hour time frame. This rule 
allows a seller to fill a prescription that is inaccurate, expired, 
or falsified simply because the prescriber has been unable to 
respond within eight hours. As a result, patients suffer serious eye 
injuries by wearing ill-fitted contacts.''); Massachusetts Society 
of Eye Physicians and Surgeons (NPRM Comment #4270).
    \543\ Sanders (SNPRM Comment #61); Wisniewski (NPRM Comment 
#1769); Hanian (NPRM Comment #153).
    \544\ See Section III, supra.
---------------------------------------------------------------------------

    Finally, commenters again requested that the Commission bring 
enforcement actions against sellers that sell lenses after the 
expiration of the prescription.\545\ As stated in the NPRM, if the 
Commission receives credible evidence that sellers are selling contact 
lenses when they have actual knowledge that the prescriptions are 
expired (either because they were presented with a copy of an expired 
prescription or received a response from a prescriber within the time 
frame specified in the Rule telling the seller that the prescription is 
expired), the Commission will take appropriate steps to investigate the 
allegations.\546\
---------------------------------------------------------------------------

    \545\ Cooper Vision, Inc. (SNPRM Comment #130); Stout (WS 
Comment #450); Stolicker (NPRM Comment #10); Osetek (NPRM Comment 
#22); Bass (NPRM Comment #55); Coalition for Patient Vision Care 
Safety (NPRM Comment #3883); Letter from Congressman David Roe to 
Chairman Joseph Simons (Nov. 29, 2018).
    \546\ NPRM, 81 FR at 88547.
---------------------------------------------------------------------------

XI. Paperwork Reduction Act

    The existing Rule contains recordkeeping and disclosure 
requirements that constitute ``collection[s] of information'' as 
defined by 5 CFR 1320.3(c) under Office of Management and Budget 
(``OMB'') regulations that implement the Paperwork Reduction Act 
(``PRA''), 44 U.S.C. 3501 et seq.\547\ On May 28, 2019, the Commission 
issued a SNPRM proposing amendments that would contain new information 
collection requirements subject to OMB review and approval. 
Specifically, the SNPRM estimated an additional recordkeeping burden 
for prescribers resulting from the proposed Rule modifications to 
597,917 hours (85,417 hours regarding signatures + 512,500 hours 
regarding their retention) and the associated estimated annual labor 
cost burden of $13,244,727.\548\ On the same date, the Commission also 
submitted a request to OMB seeking approval for the new information 
collections associated with the proposed rulemaking. On September 20, 
2019, the OMB directed the Commission to examine public comments 
relating to the proposed rulemaking and describe any public comments 
received regarding the collection, as well as why the Commission did or 
did not incorporate the commenter's recommendation.\549\ Below, the 
Commission describes and discusses the amendments to the Final Rule, 
the public comments received relating to the collection of information 
burden associated with the SNPRM, and the Commission's ultimate 
determination of the burden generated by the final amendments.
---------------------------------------------------------------------------

    \547\ On October 2, 2019, the Commission requested permission 
from OMB to continue these pre-existing information collections, 
which were estimated to be 2,104,050 annual hours of burden (which 
were derived by adding 1,045,650 disclosure hours for contact lens 
prescribers to 1,058,400 recordkeeping hours for contact lens 
sellers). See 84 FR 51162 (Sept. 27, 2019); Agency Information 
Collection Activities; Submission for OMB. On December 9, 2019, OMB 
approved the Rule's existing information collection requirements 
through December 31, 2022. OMB Control No. 3804-0127. See 84 FR 
51162 (Sept. 27, 2019); Agency Information Collection Activities; 
Submission for OMB Review; Comment Request.
    \548\ See 84 FR at 24693-94 (May 28, 2019); Supplemental notice 
of proposed rulemaking; request for public comment.
    \549\ OMB Control No. 3804-0127, ICR Reference No. 201910-3084-
001, Notice of Office of Management and Budget Action (Sept. 10, 
2019).
---------------------------------------------------------------------------

    The Commission has made a number of modifications to the Rule that 
contain recordkeeping requirements that are collections of information 
as defined by 5 CFR 1320.3(c). First, the Rule has been modified to 
require that prescribers either: (A) Obtain from patients, and maintain 
for a period of not less than three years, a signed confirmation of 
prescription release on a separate stand-alone document; (B) obtain 
from patients, and maintain for a period of not less than three years, 
a patient's signature on a confirmation of prescription release 
included on a copy of a patient's prescription; (C) obtain from 
patients, and maintain for a period of not less than three years, a 
patient's signature on a confirmation of

[[Page 50707]]

prescription release included on a copy of a patient's contact lens 
fitting sales receipt; or (D) provide each patient with a copy of the 
prescription via online portal, electronic mail, or text message, and 
for three years retain evidence that such prescription was sent, 
received, or, if provided via an online-patient portal, made 
accessible, downloadable, and printable by the patient.\550\ For 
prescribers who choose to offer an electronic method of prescription 
delivery, the Final Rule requires that such prescribers identify the 
specific method or methods to be used, and maintain records or evidence 
of affirmative consent by patients to such digital delivery for three 
years.\551\ For instances where a consumer refuses to sign the 
confirmation or accept digital delivery of their prescription, the 
Final Rule directs the prescriber to note the refusal and preserve this 
record as evidence of compliance.\552\ None of these new requirements, 
however, would apply to prescribers who do not have a direct or 
indirect financial interest in the sale of contact lenses.\553\
---------------------------------------------------------------------------

    \550\ 16 CFR 315.3(c)(1).
    \551\ 16 CFR 315.2.
    \552\ 16 CFR 315.3(c)(1)(iii).
    \553\ 16 CFR 315.3(c)(3).
---------------------------------------------------------------------------

    Additional modifications to the Rule that constitute collections of 
information as defined by 5 CFR 1320.3(c) require that sellers who use 
calls containing automated verification messages: (1) Record the entire 
call; (2) commence the call by identifying it as a request for 
prescription verification; (3) provide the information required by 
Sec.  315.5(b) in a slow and deliberate manner and at a reasonably 
understandable volume; and (4) give the prescriber the option to repeat 
the information.\554\ The call recordings must be preserved for at 
least three years.\555\
---------------------------------------------------------------------------

    \554\ 16 CFR 315.5(d).
    \555\ 16 CFR 315.5(h)(4).
---------------------------------------------------------------------------

    The Commission hereby provides PRA burden estimates, analysis, and 
discussion for the requirements to collect patient signatures as 
confirmation of prescription release and as consent to electronic 
prescription delivery; and the requirement to record automated 
verification messages; and associated recordkeeping obligations.

A. Confirmation of Prescription Release and Affirmative Consent to 
Digital Delivery of a Prescription

1. SNPRM Burden Estimate for the Confirmation of Prescription Release
    In its SNPRM, the Commission put forth estimates for the additional 
burden on individual prescribers' offices to generate and present to 
patients the confirmations of prescription release, and to collect and 
maintain the confirmations of prescription release for a period of not 
less than three years.\556\ As set out in the PRA section's 
introductory paragraph above, the Commission previously calculated this 
burden to be 597,917 hours (85,417 hours for prescribers to collect 
patient signatures and 512,500 hours for prescribers' office staff to 
store them).\557\ Based on average hourly wage rates, the Commission 
calculated the aggregate labor cost burden (totaling prescribers and 
prescribers' office staff) at $13,244,727.\558\ The Commission noted, 
however, that arguably, the overall burden of the Rule--including 
verification costs previously approved by the Office of Management and 
Budget \559\--could be lower (or not increase) given the proposed 
modification's potential offsetting effects of more patients being in 
possession of their prescriptions and consequently fewer 
verifications.\560\
---------------------------------------------------------------------------

    \556\ SNPRM, 84 FR at 24692.
    \557\ Id. at 24693.
    \558\ Id. at 24694. This estimate was based on a mean hourly 
wage of $57.26 for optometrists and $16.30 for office clerks. 
Economic News Release, U.S. Dep't of Labor, Bureau of Labor 
Statistics, Table 1. National employment and wage data from the 
Occupational Employment Statistics survey by occupation, May 2017.
    \559\ See note 549, supra.
    \560\ SNPRM, 84 FR at 24693-94.
---------------------------------------------------------------------------

    The Commission requested comment on the accuracy of the FTC's 
burden estimates, including whether the methodology and assumptions 
used are valid (such as whether prescribers or office staff are more 
likely to collect patient signatures and retain associated 
recordkeeping), and a quantification of the reduction in verifications 
resulting from the confirmation of prescription proposal.\561\
---------------------------------------------------------------------------

    \561\ Id.
---------------------------------------------------------------------------

2. Comments Regarding the SNPRM Estimate for the Confirmation of 
Prescription Release Requirement
    In response to the Commission's SNPRM proposal, several commenters 
reiterated that obtaining and storing the Confirmations of Prescription 
Release would create ``onerous'' administrative and financial burdens, 
but most commenters did not supply financial estimates for this 
burden.\562\ The AOA, which had previously estimated the cost of the 
NPRM's signed-acknowledgment proposal to be as high as $18,795 per 
optometrist,\563\ did not submit a new burden estimate for the 
Confirmation of Prescription Release proposal, but did opine that the 
increased flexibility of the new proposal would not reduce the overall 
burden on prescribers.\564\ One commenter estimated that it would cost 
his practice $10,000 per year in ``paperwork, storage, and time spent 
by secretaries handling paperwork,'' but did not provide details about 
his practice (the number of patients and prescribers, for instance) or 
how the estimate was derived, and what the cost amounted to on a per-
patient or per-prescription basis.\565\ Another commenter, Dr. Thomas 
Steinemann, wrote, ``I dispute the FTC contention that each 
documentation will only take `one minute.' Additional documentation can 
actually take several minutes when there are discrepancies in 
verification.'' \566\ Dr. Steinemann commented that according to his 
office manager, the ``additional steps of verification and 
documentation'' would add 10 minutes of administrative time per 
patient.\567\ The comment, however, does not articulate how the 
Confirmation of Prescription Release requirement can create 
discrepancies in verification, or what ``additional steps of 
verification'' Dr. Steinemann or his office manager are referring to. 
The Confirmation of Prescription Release requirement does not directly 
impact the requirement that prescribers verify prescriptions upon 
request, other than to potentially make such requests less common if 
more patients have possession of their prescriptions and can present 
them to sellers when ordering.
---------------------------------------------------------------------------

    \562\ See Section II.C.7, supra.
    \563\ American Optometric Association (NPRM Comment #3830). As 
noted in note 247, supra, the Commission explained in the SNPRM that 
it could not accord this estimate significant weight because it was 
based not on the cost of the proposed Signed Acknowledgment but on 
the overall cost of government regulations (including those already 
in place), and because the survey had numerous methodological 
limitations. SNPRM, 84 FR at 24677.
    \564\ American Optometric Association (SNPRM Comment #96). A few 
SNPRM commenters reiterated the AOA's $18,000 estimate (which the 
Commission previously determined it could not rely on, for reasons 
explained in the SNPRM), 84 FR at 24677, but did not provide 
additional information or empirical support for this figure. Koerber 
(SNPRM Comment #110); American Society of Cataract and Refractive 
Surgery (SNPRM Comment #127).
    \565\ Pierce (SNPRM Comment #17).
    \566\ Steinemann (SNPRM Comment #65); Steinemann (SNPRM Comment 
#138).
    \567\ Id.
---------------------------------------------------------------------------

    In contrast to those critical of the burden and the Commission's 
SNPRM PRA analysis, other commenters contended that the burden of the 
new requirement would be minimal or offset by a reduced burden in other 
respects of the Rule.\568\ One commenter, the ITIF, asserted that 
evidence that the new

[[Page 50708]]

requirement would increase prescriber costs ``appears to be 
significantly overstated,'' and noted that storing confirmation 
signatures in paper takes up ``very little room and cost,'' and, if 
stored electronically, storage costs are ``essentially zero.'' \569\ 
The ITIF also stated allowing prescribers to deliver prescriptions 
digitally would reduce the ``already small'' burden on prescribers of 
the confirmation of release requirement, and at the same time reduce 
the number of verification calls from third party lens sellers, thus 
further reducing the overall burden on both sellers and 
prescribers.\570\
---------------------------------------------------------------------------

    \568\ See Section II.C.7, supra.
    \569\ Information Technology & Innovation Foundation (SNPRM 
Comment #103).
    \570\ Id. See also National Association of Optometrists and 
Opticians (SNPRM Comment #129) (stating that with more practitioners 
moving to practice management systems and electronic health records, 
digital delivery of contact lens prescriptions is a ``very 
feasible'' option for many prescribers, which will further reduce 
the burden of the confirmation requirement).
---------------------------------------------------------------------------

    Another commenter, the National Taxpayers Union (``NTU''), felt the 
SNPRM burden-estimates were ``plausible,'' and noted that the FTC's 
estimates were based on underlying assumptions that may be overly 
cautious, and thus lead to overcounting.\571\ In particular, the NTU 
noted that the Commission, in calculating the SNPRM's PRA burden: (1) 
Assumed that only optometrists would obtain patient signatures, when, 
in fact, support staff--who are paid less per hour--are permitted to do 
so; (2) provided sample confirmation language so prescribers wouldn't 
have to formulate their own; (3) assumed that every provider would 
spend a minute per confirmation even though states already impose 
recordkeeping requirements, and electronic storage might take seconds; 
and (4) did not account for potentially offsetting reductions in burden 
hours for eye care providers due to reduced time and effort spent 
responding to verification requests (since more patients would have 
possession of their prescriptions and be able to present them to third-
party contact lens sellers).\572\
---------------------------------------------------------------------------

    \571\ National Taxpayers Union (SNPRM Comment #149).
    \572\ Id. See also National Association of Optometrists and 
Opticians (SNPRM Comment #129) (stating that with more patients in 
possession of their prescriptions, there would be fewer orders 
relying on the verification process).
---------------------------------------------------------------------------

    Likewise, 1-800 CONTACTS submitted a new analysis from Stanford 
Health Research Professor Laurence Baker that called the Commission's 
burden analysis ``conservative,'' and estimated that a reduction in 
verification requests by 13-15% would be sufficient to offset all of 
the costs of the confirmation requirement.\573\
---------------------------------------------------------------------------

    \573\ 1-800 CONTACTS (SNPRM Comment #135).
---------------------------------------------------------------------------

    None of the SNPRM commenters offered detailed suggestions for 
reducing the burden resulting from the Confirmation of Prescription 
Release proposal, other than to suggest that the Commission withdraw 
its proposal completely or choose a substantially different 
alternative, such as signage or public education.\574\ For reasons 
discussed in Section II.C.6., supra, the Commission does not believe 
such alternatives would effectively serve the purpose of the Rule.
---------------------------------------------------------------------------

    \574\ See Section II.C.6, supra.
---------------------------------------------------------------------------

3. Estimated Additional Burden Hours for the Confirmation of 
Prescription Release Requirement
    Commission staff estimates the PRA burden of the Confirmation of 
Prescription Release requirement based on comments received and its 
long-standing knowledge and experience with the eye care industry.\575\ 
Staff continues to believe there will be an additional burden on 
individual prescribers' offices to satisfy the confirmations of 
prescription release requirements, but that this burden will be 
relatively small in the context of the overall market for contact 
lenses and examinations.\576\
---------------------------------------------------------------------------

    \575\ See Section I.B., supra, discussing the Commission's three 
decades of experience with the optical goods industry.
    \576\ One survey estimated that the U.S. contact lens market 
totaled approximately $5,012,800,000 (not counting examination 
revenue) in 2017. ``Vision Markets See Continued Growth in 2017, 
VisionWatch Says,'' Vision Monday, March 20, 2018, http://www.visionmonday.com/business/research-and-stats/article/vision-markets-see-continued-growth-in-2017-visionwatch-says/. See also 
note 609 and accompanying text, infra.
---------------------------------------------------------------------------

    The number of contact lens wearers in the United States is 
currently estimated to be approximately 45 million.\577\ Therefore, 
assuming an annual contact lens exam for each contact lens wearer, the 
Confirmation of Prescription Release requirement would require that 45 
million people either read and sign a Confirmation of Prescription 
Release or agree to receive their prescription electronically.
---------------------------------------------------------------------------

    \577\ Centers for Disease Control, Healthy Contact Lens Wear and 
Care, Fast Facts, https://www.cdc.gov/contactlenses/fast-facts.html. 
This is an updated figure that represents an increase of four 
million wearers since the NPRM and SNPRM estimates were prepared.
---------------------------------------------------------------------------

    Nothing in the comments to the SNPRM alters the Commission's belief 
that generating and presenting the Confirmation of Prescription Release 
will not require significant time or effort. The comments describing 
the burden as crippling and onerous do not contain empirical facts or 
data regarding the amount of time and cost of the Commission's 
proposal, and some estimates appear overstated.
    The Commission continues to believe that creating the Confirmation 
of Prescription Release should not be difficult to implement since the 
requirement is flexible in that it allows any one of several different 
modalities and delivery methods, including adding the confirmation to 
existing documentation that prescribers routinely provide (sales 
receipts) or are already required to provide (prescriptions) to 
patients. The requirement is also flexible in that it does not 
prescribe other details such as the precise content or language of the 
patient confirmation, but merely requires that, if provided to the 
patient pursuant to options specified in Sec.  315.3(c)(1)(i)(A), (B), 
and (C), the confirmation from the patient must be in writing. At the 
same time, it is not required that prescribers spend time formulating 
their own content for the confirmation, since the Rule provides draft 
language that prescribers are free to use, should they so desire. 
Furthermore, the confirmation requirement is flexible enough to cover 
situations where a contact lens fitting is completed remotely, since a 
prescriber can readily satisfy the confirmation and prescription-
release requirements by various methods, including email, text, or 
uploading the prescription to a patient portal, so long as the patient 
consents to such delivery.
    The four options for a prescriber to confirm a prescription release 
to a patient are set out in Sec.  315.3(c)(1)(i)(A), (B), (C), and (D). 
The requirement in options (A), (B), and (C) to provide the patient 
with a Confirmation of Prescription Release statement are not 
disclosures constituting an information collection under the PRA 
because the FTC, in Sec.  315.3(c)(1)(ii), has supplied the prescriber 
with draft language the prescriber can use to satisfy this 
requirement.\578\ As noted above, however, the requirement in (A), (B), 
and (C) to collect a patient's signature on the Confirmation of 
Prescription Release and preserve it constitutes an information 
collection as defined by OMB regulations that implement the PRA. 
Nonetheless, the Commission believes it will require minimal time for a 
patient to read the confirmation and provide a signature. The 
Commission estimated in the SNPRM that it would

[[Page 50709]]

take patients ten seconds to read the one-sentence Confirmation of 
Prescription Release and provide a signature,\579\ and the Commission 
believes that ten seconds remains an appropriate estimate.
---------------------------------------------------------------------------

    \578\ ``The public disclosure of information originally supplied 
by the Federal government to the recipient for the purpose of 
disclosure to the public is not included within'' the definition of 
``collection of information.'' 5 CFR 1320.3(c)(2).
    \579\ SNPRM, 84 FR at 24693. This estimate was based on 
responses to a consumer survey regarding how long it would take 
consumers to read the Signed Acknowledgment, and a prior PRA 
estimate for consumers to complete a similar signed acknowledgment.
---------------------------------------------------------------------------

    The fourth option, Sec.  315.3(c)(1)(i)(D), does not, in and of 
itself, constitute an information collection under the PRA, since no 
new information that would not otherwise be provided under the Rule is 
provided to or requested from the patient.\580\ Excluding that option 
from consideration, and assuming the remaining three options are 
exercised with equal frequency, 75% of approximately 45 million annual 
prescription releases will entail reading and signing a confirmation 
statement. Thus, assuming ten seconds for each release, prescribers and 
their office staff would devote 93,750 hours, cumulatively (75% x 45 
million prescriptions yearly x 10 seconds each) to obtaining patient 
signatures as confirmations of prescription release.\581\
---------------------------------------------------------------------------

    \580\ In order to utilize Sec.  315.3(c)(1)(i)(D), however, a 
prescriber must obtain and maintain records or evidence of 
affirmative consent by patients to electronic delivery of their 
prescriptions. 16 CFR 315.2. The burden to do so is included in the 
recordkeeping burden calculation of this PRA Section.
    \581\ Section 315.3(c)(1)(iii) also requires that in the event 
that a patient declines to sign a confirmation requested under 
paragraphs (c)(1)(i)(A), (B), or (C), the prescriber must note the 
patient's refusal on the document and sign it. However, the 
Commission has no reason to believe that such notation should take 
any longer than for the patient to read and sign the document, so 
the Commission will maintain its calculation as if all confirmations 
requested under (c)(1)(i)(A), (B), or (C) require the same amount of 
time.
---------------------------------------------------------------------------

    Maintaining those signed confirmations for a period of not less 
than three years should also not impose substantial new burdens on 
individual prescribers and office staff. The majority of states already 
require that optometrists keep records of eye examinations for at least 
three years,\582\ and thus many prescribers who opt to include the 
confirmation of prescription release on the prescription itself would 
be preserving that document, regardless. Similarly, most prescribers 
already retain customer sales receipts for financial accounting and 
recordkeeping purposes, and thus prescribers who opt to include the 
confirmation of prescription release on the sales receipt also could be 
retaining that document, regardless. Moreover, storing a one-page 
document per patient per year should not require more than a few 
seconds, and an inconsequential, or de minimis, amount of record space. 
Some prescribers might also present the Confirmation of Prescription 
Release in electronic form, enabling patients to sign a computer screen 
or tablet directly and have their confirmation immediately stored as an 
electronic document. For other prescribers, the new recordkeeping 
requirement would likely require that office staff either preserve the 
confirmation in paper format, or electronically scan the signed 
confirmation and save it as an electronic document. For prescribers who 
preserve the confirmation electronically by scanning it, Commission 
staff estimates that saving such a document would consume approximately 
one minute of staff time. Commission staff does not possess detailed 
information on the percentage of prescribers' offices that currently 
use and maintain paper forms, electronic forms, or that scan paper 
files and maintain them electronically. Thus, for purposes of this PRA 
analysis, Commission staff will assume that all prescriber offices who 
opt for Sec.  315.3(c)(1)(i) (A), (B), or (C) require a full minute per 
confirmation for recordkeeping arising from the modifications. 
Excluding from PRA consideration the fourth option, Sec.  
315.3(c)(1)(i)(D), as there is no signature to obtain or retain, and 
assuming that prescribers elect the other options three-fourths or 75% 
of the time, the recordkeeping burden for all prescribers to scan and 
save such confirmations would amount to 562,500 hours (75% x 45 million 
prescriptions yearly x one minute for scanning and storing) per year.
---------------------------------------------------------------------------

    \582\ See, e.g., 246 Mass. Code Regs. Sec.  3.02 (requiring 
optometrists to maintain patient records for at least seven years); 
Wash. Admin. Code Sec.  246-851-290 (requiring optometrists to 
maintain records of eye exams and prescriptions for at least five 
years); Iowa Admin. Code r. 645-182.2(2) (requiring optometrists to 
maintain patient records for at least five years); Fla. Admin. Code 
r. 64B13-3.003(6) (requiring optometrists to maintain patient 
records for at least five years).
---------------------------------------------------------------------------

    As noted previously, the fourth option for satisfying the 
Confirmation of Prescription Release requirement does not necessitate 
that prescribers obtain or maintain a record of the patient's signature 
confirming receipt of her prescription. However, as explained in Sec.  
315.2, under the Rule's now-modified definition of Provide to the 
patient a copy, in order to avail themselves of the fourth option, 
prescribers must obtain and maintain records or evidence of the 
patients' affirmative consent to electronic delivery for three years. 
In order to remain as cautious as possible in estimating the burden, 
the Commission will use the assumption that consumers sign such 
consents for electronic delivery pursuant to Sec.  315.3(c)(1)(i)(D) 
for one quarter of the 45 million prescriptions released per year,\583\ 
and that this task would take the same amount of time as to obtain and 
maintain a signature of the patient's Confirmation of Prescription 
Release. Thus, the Commission will allot 218,750 hours \584\ for the 
time required for prescribers to obtain affirmative consents and 
maintain records of same.
---------------------------------------------------------------------------

    \583\ 11,250,000 (45 million prescriptions x 25%).
    \584\ 31,250 hours (11,250,000 prescriptions yearly x 10 
seconds) for obtaining the signature plus 187,500 hours (11,250,000 
affirmative consents x one minute) for storing such records.
---------------------------------------------------------------------------

    Therefore, the estimated incremental PRA recordkeeping burden for 
prescribers and their staff resulting from the Confirmation of 
Prescription Release modifications to the Rule amounts to 906,250 total 
hours ((93,750 and 31,250 hours, respectively, to obtain signatures 
confirming release and consenting to electronic delivery) plus (562,500 
and 218,750 hours, respectively, to maintain such records for three 
years)).
    As some commenters noted, the overall burden of the Rule--
particularly verification costs previously approved by the Office of 
Management and Budget \585\--could lessen (or not increase by as much 
as the incremental burden from the proposed Rule modifications), given 
potentially offsetting effects presented by the Commission's Rule 
modifications.\586\ With more patients in possession of their 
prescriptions (due to increased prescription release), and a greater 
ability to present them to sellers (due to the modification requiring 
sellers to provide a method for patients to present prescriptions) 
fewer time-consuming verifications would be necessary.\587\
---------------------------------------------------------------------------

    \585\ See note 549, supra.
    \586\ See Information Technology & Innovation Foundation (SNPRM 
Comment #103); 1-800 CONTACTS (SNPRM Comment #135); National 
Taxpayers Union (SNPRM Comment #149).
    \587\ Id.
---------------------------------------------------------------------------

    Based on new projections from 1-800 CONTACTS \588\ and a previous 
analysis by the Commission,\589\ a decrease of between 13%-23% in 
verifications could be sufficient to offset the entire cost of the 
Confirmation of Prescription Release requirement. In the SNPRM, 
however, the Commission noted that these estimates rely on a number of 
assumptions, not all of which are confirmed as accurate.\590\ 
Furthermore,

[[Page 50710]]

neither 1-800 CONTACTS, nor any other commenter, provided empirical 
data or projections as to how much the number of verifications will 
decline due to the Rule modifications. The Commission continues to lack 
this data, and thus cannot predict whether the verification decrease--
should it occur--would be sufficient to offset any or all of the 
burden. Therefore, the Commission will not make an adjustment for 
offsetting effects and benefits at this time.
---------------------------------------------------------------------------

    \588\ 1-800 CONTACTS (SNPRM Comment #135) (estimating that a 
reduction of 13%-15% in verifications would offset the estimated 
costs of the proposal).
    \589\ SNPRM, 84 FR at 24693-94.
    \590\ Id. at 24678. The calculation also does not take into 
account any of the benefit to consumers from having their 
prescriptions and being able to choose from among competing sellers; 
the savings consumers might achieve by purchasing lower-priced 
lenses; the improvements to health and safety due to a reduction in 
errors associated with invalid prescriptions currently verified 
through passive verification; and the Commission's ability to assess 
and verify compliance with the Rule.
---------------------------------------------------------------------------

    For this specific reason, and the various cautious assumptions 
described above, the Commission's estimate of 906,250 total hours for 
prescribers and their staff resulting from the Confirmation of 
Prescription Release requirement may well overstate the burden of the 
modification. Furthermore, the actual burden should be even lower 
because none of the Confirmation of Prescription Release requirements 
apply to prescribers who do not have a direct or indirect financial 
interest in the sale of contact lenses. The Commission requested but 
did not receive comment on the percentage of prescribers who might be 
exempt, and does not currently possess sufficient information to 
determine what percentage of prescribers do not have a financial 
interest in the sale of contact lenses. The Commission thus has not 
reduced the estimated PRA burden accordingly at this time.
4. Estimated Total Labor Cost Burden for the Confirmation of 
Prescription Release Modification
    Commission staff derives labor costs by applying appropriate 
hourly-cost figures to the burden hours described above. The task to 
obtain patient confirmations and consent to electronic delivery could 
theoretically be performed by medical professionals (e.g., 
optometrists, ophthalmologists) or their support staff (e.g., 
dispensing opticians, medical technicians, office clerks). In the 
SNPRM, the Commission requested comment as to whether prescribers or 
office staff are more likely to collect patient signatures and retain 
associated recordkeeping, but did not receive significant guidance on 
this. Therefore, staff will continue to assume that optometrists will 
perform the task of collecting patient signatures, and staff will 
perform the labor pertaining to printing, scanning, and storing of 
documents, even though this may lead to some overcounting of the 
burden.
    According to the Bureau of Labor Statistics, salaried optometrists 
earn an average wage of $57.68 per hour, and general office clerks earn 
an average wage of $16.92 per hour.\591\ Using the aforementioned 
estimate of 125,000 total prescriber labor hours for obtaining patient 
signatures, the resultant aggregate labor costs to obtain patient 
signatures is $7,210,000 (125,000 hours x $57.68).
---------------------------------------------------------------------------

    \591\ Press Release, Bureau of Labor Statistics, United States 
Department of Labor, Occupational Employment Statistics--May 2018, 
https://www.bls.gov/news.release/ocwage.t01.htm.
---------------------------------------------------------------------------

    As previously noted, Commission staff assumes that office clerks 
will typically perform the labor pertaining to the printing, scanning 
and storing of prescription release confirmations. Applying a mean 
hourly wage for office clerks of $16.92 per hour to the aforementioned 
estimate of 781,250 hours, cumulative labor costs for those tasks would 
total $13,218,750.
    Therefore, combining the aggregate labor costs for both prescribers 
and office staff to obtain signed patient confirmations and consent to 
electronic delivery and preserve the associated records, the Commission 
estimates the total labor burden of the Confirmation of Prescription 
Release modification to be $20,428,750. This represents an increase 
from the SNPRM's estimated burden for the Confirmation of Prescription 
Release proposal due to a relatively large increase in the number of 
contact lens wearers now estimated by the Centers for Disease 
Control,\592\ increases in the estimated wages of optometrists and 
office staff by the Bureau of Labor Statistics,\593\ and the additional 
Rule modification requiring prescribers to collect and preserve 
patients' affirmative consent to electronic delivery of their 
prescriptions.
---------------------------------------------------------------------------

    \592\ Centers for Disease Control, Healthy Contact Lens Wear and 
Care, Fast Facts, https://www.cdc.gov/contactlenses/fast-facts.html.
    \593\ Press Release, Bureau of Labor Statistics, United States 
Department of Labor, Occupational Employment Statistics--May 2018, 
https://www.bls.gov/news.release/ocwage.t01.htm.
---------------------------------------------------------------------------

5. Capital and Other Non-Labor Costs for the Confirmation of 
Prescription Release Requirement
    The proposed recordkeeping requirements detailed above regarding 
prescribers impose negligible capital or other non-labor costs, as 
prescribers likely have already the necessary equipment and supplies 
(e.g., prescription pads, patients' medical charts, scanning devices, 
recordkeeping storage) to perform those requirements.

B. Recording of Automated Telephone Messages

    As noted above, the Commission has further modified the Rule to 
require that sellers who use automated verification messages record the 
calls and preserve the recordings for three years. In the SNPRM, the 
Commission staff did not put forth a specific burden estimate for this 
requirement, but rather sought comments to help inform such estimated 
burden, to the extent applicable.\594\
---------------------------------------------------------------------------

    \594\ SNPRM, 84 FR at 24694.
---------------------------------------------------------------------------

    The Commission received a few comments stating that the requirement 
presented a burden for sellers.\595\ 1-800 CONTACTS, for instance, 
commented that the requirement to store the recorded calls would impose 
a costly new burden while providing relatively few associated 
benefits.\596\ Consumer Reports essentially reiterated this view.\597\ 
None of the commenters, however, provided data or cost figures that 
would help inform the Commission's estimated burden.
---------------------------------------------------------------------------

    \595\ See Sections III.B., C. and D, supra.
    \596\ 1-800 CONTACTS (SNPRM Comment #135).
    \597\ Consumer Reports (SNPRM Comment #133).
---------------------------------------------------------------------------

    The Commission does not believe that requiring sellers who use 
automated telephone messages for verification to record the calls and 
preserve the recordings will create a substantial burden. The 
requirement will not require additional labor time for sellers, since 
the verification calls will be for the same duration that they are now 
(the length of time required to submit the information required for 
verification under Sec.  315.5 (b)). However, the new requirement will 
likely require capital and other non-labor costs to record the calls 
and store them electronically. But sellers who utilize automated 
telephone messages for verification are already availing themselves of 
sophisticated communication technology, and thus should not find it 
daunting to implement technology to record such calls. Meanwhile the 
growth of digital recording technology, and the capital investment 
required for recording equipment and record storage, is rapidly 
declining and has been for some time.\598\ A phone service provider 
used by at least one online contact lens seller, for example, 
advertises that it charges a quarter of one cent ($.0025) for each 
minute recorded, plus a storage fee of $.0005-per-month for each minute 
of

[[Page 50711]]

recorded storage over 10,000.\599\ In other words, assuming each 
verification call requires three minutes of recording, the first 3333 
verification calls recorded and stored would cost $25 (three-fourths of 
one cent per call),\600\ and each additional verification call would 
cost approximately six cents apiece to record and store for three 
years.\601\ Other phone service providers surveyed advertise call-
recording options such as $4.99 per gigabyte (about 5000 minutes) of 
recorded calls (about 4/10th of a cent per verification call),\602\ and 
1000 minutes of call recording for $14.95 (approximately 4.5 cents per 
verification call).\603\ Some services also advertise unlimited call-
recording plans ranging anywhere from $20-70 a month, depending on how 
many lines, and how much storage is required.\604\ The costs of these 
services would vary depending on what other options are selected, how 
long storage is required, and the size of the order, among other 
things, and the Commission does not vouch for the sufficiency of any of 
these services. Rather, the Commission mentions these advertised 
promotions to demonstrate that the cost of recording calls does not 
appear to be burdensome. Moreover, the Commission believes, as stated 
in Section III, supra, that any incremental costs to sellers for 
recording calls is outweighed by the benefit to consumers and 
prescribers from curtailing invalid verification calls. For purposes of 
calculating the PRA burden, however, the Commission will estimate that 
each three-minute verification call costs five cents to record.
---------------------------------------------------------------------------

    \598\ See Final Rule, Telemarketing Sales Rule, 68 FR 4622 (Jan. 
29, 2003) (discussing the cost for recording calls, and determining 
it was not a significant obstacle for telemarketers).
    \599\ Twilio Support, https://support.twilio.com/hc/en-us/articles/223132527-How-much-does-it-cost-to-record-a-call-.
    \600\ (10,000 minutes x $.0025) / 3333 three-minute calls = 
$.0075 per call.
    \601\ Id. For each additional three-minute verification call, it 
would cost three-quarters of a cent to record and .15 of a cent per 
month to store the recording (5.4 cents for 36 months), for a total 
of 6.15 cents per call.
    \602\ https://getvoip.com/blog/2017/11/16/call-recording/; see 
also https://jive.com/features/call-recording (estimating that one 
gigabyte typically stores about 5,000 minutes of recorded calls).
    \603\ https://www.phone.com/pricing-all/.
    \604\ https://www.avoxi.com/blog/best-call-recording-service/.
---------------------------------------------------------------------------

    According to recent survey data, approximately 36% of contact lens 
purchases are from a source other than the prescriber.\605\ Assuming 
that each of the 45 million contact lens wearers in the U.S. makes one 
purchase per year, this would mean that approximately 16,200,000 
contact lens purchases (45 million x 36%) are made annually from 
sellers other than the prescriber. Based on prior discussions with 
industry, approximately 73% of sales by non-prescriber sellers require 
verification, meaning that approximately 11,826,000 purchases would 
require verification calls, faxes, or emails (16,200,000 x 73%). The 
Commission does not possess information as to the percentage of 
verifications completed by telephone versus fax or email. Thus for 
purposes of this analysis, the Commission will assume that all 
verifications are performed via telephone. Furthermore, the Commission 
does not have information as to the percentage of telephone 
verifications that are automated as opposed to live calls, and thus 
will assume that all telephone verifications are automated calls and 
subject to the new call-recording requirement.
---------------------------------------------------------------------------

    \605\ Jason J. Nichols & Deborah Fisher, ``2018 Annual Report,'' 
Contact Lens Spectrum, Jan. 1, 2019, https://www.clspectrum.com/issues/2019/january-2019; VisionWatch, Contact Lenses, September 
2019.
---------------------------------------------------------------------------

    Based on the aforementioned assumptions, the Commission estimates 
that the requirement to record automated telephone messages will 
require recording 11,826,000 calls \606\ at an annual cost to third-
party sellers, in the aggregate, of $591,300 (11,826,000 x $.05).
---------------------------------------------------------------------------

    \606\ In some instances, sellers may have to call more than once 
to verify an order. In those instances, however, only the recording 
of the successful verification would need be preserved.
---------------------------------------------------------------------------

C. Total Burden for the Modifications to the Rule

    Combining the marginal cost of the Rule modifications for both 
sellers and prescribers, the Commission estimates that the amendments 
will impose an additional burden of $21,020,050 ($20,428,750 for 
prescribers + $591,300 for third-party sellers). Adding these estimated 
costs to the OMB's already approved existing cost burden ($84,548,448) 
results in a total PRA burden from the Rule of $105,568,498. While not 
insubstantial, this represents just two percent of the overall 
$5,012,800,000 contact lens market in the United States.\607\ Moreover, 
as noted previously, the estimated burden is calculated using several 
cautious assumptions that may overstate the actual cost; in all 
likelihood, the actual burden will be significantly less.
---------------------------------------------------------------------------

    \607\ ``Vision Markets See Continued Growth in 2017, VisionWatch 
Says,'' Vision Monday, March 20, 2018, http://www.visionmonday.com/business/research-and-stats/article/vision-markets-see-continued-growth-in-2017-visionwatch-says/. See also, Steve Kodey, US Optical 
Market Eyewear Overview, 4, https://www.ftc.gov/sites/default/files/filefield_paths/steve_kodey_ppt_presentation.pdf.
---------------------------------------------------------------------------

XII. Regulatory Flexibility Act

    The Regulatory Flexibility Act (``RFA'') \608\ requires that the 
Commission provide an Initial Regulatory Flexibility Analysis 
(``IRFA'') with a Proposed Rule, and a Final Regulatory Flexibility 
Analysis (``FRFA'') with the Final Rule, unless the Commission 
certifies that the Rule will not have a significant economic impact on 
a substantial number of small entities.\609\ The purpose of the 
regulatory flexibility analysis is to ensure that the agency considers 
the impact on small entities and examines regulatory alternatives that 
could achieve the regulatory purpose while minimizing burdens on small 
entities.
---------------------------------------------------------------------------

    \608\ 5 U.S.C. 601-612.
    \609\ 5 U.S.C. 603-605.
---------------------------------------------------------------------------

    Although the Commission believed that the amendments it proposed 
would not have a significant economic impact on small entities, it 
included an IRFA in the SNPRM and solicited public comment.\610\ In 
this section, the Commission discusses the SNPRM comments that 
addressed the IRFA,\611\ as appropriate, below. The Final Rule is 
similar to the rule proposed in the SNPRM. The Commission continues to 
believe that the amendments it is adopting will not have a significant 
economic impact upon small entities, but has nonetheless deemed it 
appropriate as a matter of discretion to provide this FRFA.
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    \610\ SNPRM, 84 FR at 24694. The Commission's NPRM also included 
an IRFA. NPRM, 81 FR at 88588.
    \611\ Unlike many other commenters who addressed the IRFA 
indirectly, the AOA commented on the RFA by name stating its belief 
that the Commission ``has not fully considered the regulatory burden 
under which physicians are already operating'' and cited to the 
Office of Advocacy of the U.S. Small Business Administration's FY 
2018 Report on the Regulatory Flexibility Act. According to the AOA, 
that report stated that ``[s]mall businesses have told advocacy 
stories that exemplify how federal regulations drain small 
businesses' resources, energy, and in some cases even their desire 
to stay in business.'' The AOA indicated that it ``has heard the 
same concerns voiced by doctors of optometry who after years of 
service in patient care find that the regulatory framework is so 
intrusive to the doctor patient relationship, [sic] that some 
consider leaving the profession.'' SNPRM Comment #96.
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A. Need for and Objectives of the Rule Amendments

    The Commission's Final Rule incorporates changes affecting 
prescribers and sellers. These changes were, in large part, previously 
addressed in the Commission's NPRM and SNPRM, including in the 
Regulatory Flexibility Act sections. As explained in the earlier IRFAs, 
the need for and objective of these changes is to clarify

[[Page 50712]]

and update the Rule in accordance with marketplace practices.
1. Amendments Affecting Prescribers
    The following changes affect prescribers, many of whom are small 
businesses: (1) Should the prescriber so choose, allow for electronic 
delivery of prescriptions as a means for automatic prescription release 
when agreed to by the patient (and in such cases, prescribers must 
retain evidence for not less than three years that the prescription was 
sent, received, or made accessible, downloadable, and printable). The 
prescriber must identify to the patient the specific method of 
electronic delivery and obtain the patient's consent to that method, 
and maintain the evidence of consent for a period of not less than 
three years; (2) Request the patient sign a confirmation of receipt of 
a contact lens prescription (and if a patient declines to sign, must 
note the patient's refusal on the document and sign it); \612\ and (3) 
Respond to authorized seller requests for copies of a prescription 
within forty business hours, and require the prescriber to make a 
notation in the patient's record when responding to such requests.
---------------------------------------------------------------------------

    \612\ This requirement does not apply to prescribers who do not 
have a direct or indirect financial interest in the sale of contact 
lenses.
---------------------------------------------------------------------------

    As explained in detail in this Final Rule notice, the Commission 
has determined that a Confirmation of Prescription Release is necessary 
for several reasons, including: (1) Multiple consumer surveys 
consistently show prescriber non-compliance with, and lack of consumer 
awareness of, the Rule's prescription-release requirement; (2) numerous 
personal accounts of prescribers' failure to release prescriptions; (3) 
the persistently high number of verifications, many of which would be 
unnecessary were consumers in possession of their prescriptions; (4) 
the regulatory structure of the contact lens market, which requires a 
consumer to obtain lenses pursuant to a prescription while permitting 
prescribers to sell what they prescribe, thus creating an incentive for 
prescribers to withhold prescriptions; and (5) the lack of credible 
empirical evidence rebutting or contradicting the evidence that 
prescribers are not automatically releasing prescriptions, and that 
consumers are not fully aware of their rights.\613\
---------------------------------------------------------------------------

    \613\ See Section II, supra.
---------------------------------------------------------------------------

    The Commission further determined that allowing prescribers to 
satisfy the automatic prescription release requirement by using an 
online patient portal or other electronic method in lieu of a paper 
copy, when the patient gives verifiable affirmative consent, offered 
benefits for sellers, prescribers, and patients. Patients would be able 
to access their prescriptions and have electronic copies to send to 
sellers. With the prescription, a seller would no longer need to submit 
a verification request, which would also benefit prescribers by 
reducing the volume of requests.\614\
---------------------------------------------------------------------------

    \614\ For a more detailed analysis of the reasons the Commission 
allowed prescribers to satisfy the automatic release requirement 
electronically in the Final Rule, see Section II.C.5., supra.
---------------------------------------------------------------------------

    The Commission is also instituting a forty-business-hour 
requirement for prescribers to provide additional copies of 
prescriptions upon request from a patient's agent to ensure that 
patients or their agents can receive additional copies of their 
prescription in a timely manner.\615\ Additionally, prescribers would 
be required to note in the patient's file the name of the requester and 
the date and time the prescription was provided so that the Commission 
is able to determine, if necessary, whether a prescriber has complied 
with the Rule.
---------------------------------------------------------------------------

    \615\ See Section VIII, supra.
---------------------------------------------------------------------------

2. Amendments Affecting Sellers
    The amendments affecting sellers require them: (1) When using 
automated telephone messages to verify prescriptions, to record the 
entire call (and maintain such recordings for a period of not less than 
three years), commence the call by identifying it as a request for 
prescription verification made in accordance with the Contact Lens 
Rule, deliver the required information in a slow and deliberate manner 
and at a reasonably understandable volume, and make the required 
information repeatable at the prescriber's option; (2) to provide 
consumers with a method that allows consumers to submit their 
prescriptions to sellers; and (3) to verify only the contact lens brand 
or manufacturer that appears on the consumer's prescription, unless the 
consumer has provided an unprescribed contact lens manufacturer or 
brand in response to a specific request from the seller.
    The Commission implemented the additional requirements for 
automated verification calls to relieve the burden on prescribers and 
reduce potential health risks to patients from incomplete or 
incomprehensible automated telephone messages. Specifically, the 
Commission noted that prescribers must be able to understand automated 
messages so they can, if necessary, respond to sellers to prevent 
improper sales. The Commission imposed the amendments in response to 
concerns about the quality of automated telephone messages, and 
instated the recording requirement because without such a record, the 
Commission cannot reliably assess whether a call was compliant, and 
further, whether the seller has a pattern of placing non-compliant 
calls (and unlawfully selling after such calls).
    The Commission also imposed a requirement for sellers to accept 
prescription presentation to reduce the number of verifications, reduce 
errors associated with incorrect verification attempts, and make it 
more difficult for ill-intentioned sellers to abuse the passive 
verification framework and take advantage of consumers who might not 
realize that the seller intends to verify a different lens than the one 
written on their prescription.
    The Commission modified the definition of alteration, and included 
an exception for sellers that verify only the contact lens brand or 
manufacturer that consumers indicate is on their prescriptions in order 
to address the emergence of several businesses that rely exclusively, 
or almost exclusively, on passive verification as a means to substitute 
their own brand of contact lenses for those originally prescribed by 
the patient's prescriber. The Commission continues to receive reports 
about the proliferation of passive verification abuses. The 
implementation of the alteration definition, including the exception, 
should serve as an effective deterrent against sellers that try to game 
the verification system to sell non-prescribed contact lenses.\616\
---------------------------------------------------------------------------

    \616\ The reasons for this Final Rule amendment are more fully 
discussed in Section VI, supra.
---------------------------------------------------------------------------

B. Significant Issues Raised by Public Comments in Response to the 
IRFA, Including Any Comments Filed by the Chief Counsel for Advocacy of 
the Small Business Administration, and the Agency's Response, Including 
Any Changes Made in the Final Rule Amendments

    The Commission did not receive any comments from the Small Business 
Administration on this Rule Review. The Commission did receive comments 
from various interested parties in response to the SNPRM, and it 
discusses them below.
1. Amendments Affecting Prescribers
    As discussed in detail in this notice, the Commission, in the 
SNPRM, determined that the Rule needs to contain some form of patient 
confirmation requirement, but the Commission made changes to its prior

[[Page 50713]]

signed-acknowledgment proposal (put forth in the NPRM) in an effort to 
reduce the burden associated with, and address other criticisms 
surrounding, the proposal. These changes included: (1) Adding an option 
for prescribers to satisfy the confirmation requirement by releasing 
the prescription electronically under certain conditions; (2) excluding 
from the requirement eye care prescribers who have no direct or 
indirect financial interest in the sale of contact lenses; and (3) 
allowing prescribers to craft their own wording of the signed 
confirmation, while providing sample confirmation language that 
prescribers can use at their discretion.\617\ In response to the SNPRM 
proposal, the Commission received a number of comments, mostly from 
prescribers, criticizing, and detailing the burden of, and other issues 
associated with complying with, the Commission's Confirmation of 
Prescription Release requirement.\618\
---------------------------------------------------------------------------

    \617\ In the Final Rule, for instances where a patient refuses 
to sign the confirmation, the Commission directs the prescriber to 
note the refusal and preserve this record as evidence of compliance.
    \618\ See Section II, supra.
---------------------------------------------------------------------------

    Other SNPRM commenters provided new views or concerns about the 
NPRM's proposal to require that prescribers respond to requests from 
patients or their agent for an additional copy of a prescription within 
forty business hours. Some commenters felt that the Commission should 
not impose a time period for prescribers to respond to requests from 
patients or their agents for an additional copy of a prescription. 
Other commenters recommended that the Commission require prescribers to 
respond to such requests within a shorter period of time. The 
Commission has determined that a defined time period is necessary, and 
that its SNPRM proposal of forty business hours should be sufficient to 
ensure prescribers comply within a reasonable amount of time, while at 
the same time limit the additional burden on them to do so.\619\
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    \619\ These commenters' concerns and the Commission's response 
to such concerns are addressed more fully in Section VIII, supra.
---------------------------------------------------------------------------

2. Amendments Affecting Sellers
    In response to the SNPRM's proposal to require that each 
verification call: commence by identifying it as a request for 
prescription verification made in accordance with the Contact Lens 
Rule; deliver the required information in a slow and deliberate manner 
and at a reasonably understandable volume; and make the required 
information repeatable at the prescriber's option, the Commission did 
not receive any comments suggesting that this resulted in a burden. 
Some commenters did raise objections, however, to the Commission's 
recording requirement, as discussed in detail in Section III.C., supra. 
For the reasons discussed in that Section and reiterated in A.2. of 
this Section, the Commission determined to retain the recording 
requirement.
    The Commission did not receive any comments opposing the SNPRM's 
proposal requiring that sellers provide a method of, and a disclosure 
of the method of, prescription presentation. The Commission did receive 
a comment, however, suggesting that the Commission require that the 
method to present prescriptions be in close proximity to the option to 
provide the parameters of the contact lens for verification. Although 
the Commission did not impose that requirement, it took that comment 
into account in determining that, to maximize the potential benefit 
from the amendment, the seller must provide and disclose the method for 
the patient to present the seller with a copy of the patient's 
prescription prior to requesting a prescriber's contact lens 
prescription. In addition, the Commission, in response to comments 
addressing the issue, provided more guidance on the methods that 
sellers need to use (i.e., the method by which the order is taken or 
email, text or file upload).
    The Commission also received comments on the SNPRM's proposed 
modification defining alteration, and providing an exception to 
alteration for sellers that verify only the brand or manufacturer that 
consumers indicate is on their prescription. Some commenters felt the 
modification was unnecessary, and that other Rule changes were adequate 
to curb the practices of substitution to non-prescribed brands through 
use of the verification system. As addressed in Section VI.B., supra, 
the Commission has determined that there are benefits to retaining this 
modification. In response to comments, however, the Commission provided 
additional guidance on the acceptable methods for obtaining brand and 
manufacturer information.

C. Description and Estimate of the Number of Small Entities to Which 
the Amendments Will Apply or Explanation Why No Estimate Is Available

    Prescribers of contact lenses are affected by the amendments 
concerning the option for electronic delivery of prescriptions as a 
means for automatic prescription release, Confirmation of Prescription 
Release, and the imposition of a forty-business-hour time frame for 
responding to authorized requests for additional copies of 
prescriptions. There are approximately 43,000 optometrists and 16,700 
ophthalmologists in the United States,\620\ though not all optometrists 
and ophthalmologists would be affected by the amendments since some do 
not prescribe contact lenses. Some prescribers who prescribe contact 
lenses also would not be affected by the Confirmation of Prescription 
Release requirement if they do not have a direct or indirect interest 
in the sale of contact lenses. Of the contact lens prescribers who are 
affected by the modifications, the Commission--based on its knowledge 
of the eye-care industry--believes that many fall into the category of 
small entities (e.g., offices of optometrists with less than $7.5 
million in average annual receipts).\621\ Determining a precise 
estimate of the number of small entities covered by the Rule's 
prescription-release requirements is not readily feasible, however, 
because most prescribers' offices are private entities that do not 
release the underlying revenue information necessary to make this 
determination.\622\ The Commission sought comment in its SNPRM 
regarding the estimated number or nature of such small business 
entities, if any, for which the proposed amendments would have a 
significant impact, and did not receive commenter guidance in return.
---------------------------------------------------------------------------

    \620\ See note 269, supra.
    \621\ See U.S. Small Business Admin., ``Table of Small Business 
Size Standards Matched to North American Industry Classification 
System Codes,'' (eff. Feb. 26, 2016), https://www.sba.gov/sites/default/files/files/Size_Standards_Table.pdf.
    \622\ 5 U.S.C. 601(6).
---------------------------------------------------------------------------

    Non-prescriber sellers of contact lenses are affected by the 
amendments concerning the additional requirements for using an 
automated telephone verification message, requirements to accept 
prescription presentation, and requirements to verify only the contact 
lens brand or manufacturer that consumers indicate is on their 
prescriptions.\623\ Based on its knowledge of the industry, staff 
believes that the number of these entities that likely qualify as small 
businesses (less than $22 million in average annual receipts) is not 
likely to be substantial.\624\
---------------------------------------------------------------------------

    \623\ Most prescribers who sell lenses do so after fitting the 
patient with the prescribed lens, and thus do not rely on 
prescription verification. The amendments affecting sellers pertain 
to verification or prescription presentation and do not pertain to 
these sales. As a result, the Commission does not consider 
prescribers in its estimated burden for the proposals affecting 
sellers.
    \624\ See U.S. Small Business Admin., ``Table of Small Business 
Size Standards Matched to North American Industry Classification 
System Codes'' (Aug. 19, 2019), https://www.ecfr.gov/cgi-bin/text-idx?SID=b919ec8f32159d9edaaa36a7eaf6b695amp;mc=true&node=pt13.1.121&r
gn=div5#se13.1.121_1201.

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[[Page 50714]]

D. Description of the Projected Reporting, Recordkeeping and Other 
Compliance Requirements of the Amendments, Including an Estimate of the 
Classes of Small Entities That Will Be Subject to the Requirement and 
the Type of Professional Skills Necessary for Preparation of the Report 
or Record

1. Amendments Affecting Prescribers
    The Confirmation of Prescription Release amendment requires that 
prescribers with a direct or indirect interest in the sale of contact 
lenses request that patients sign, and maintain for a period of not 
less than three years, either (A) a statement confirming receipt of the 
contact lens prescription; (B) a prescriber-retained copy of a contact 
lens prescription that contains a statement confirming receipt of the 
contact lens prescription; or (C) a prescriber-retained copy of the 
receipt for the examination that contains a statement confirming 
receipt of the contact lens prescription.
    As an alternative to (A), (B), and (C), under certain conditions, 
prescribers can provide a contact lens prescription digitally. In order 
to avail themselves of this option, prescribers must maintain, for a 
period of not less than three years, evidence that the prescriptions 
were sent, received, or made accessible, downloadable and printable. In 
addition, the prescriber must identify to the patient the specific 
method or methods of electronic delivery to be used, such as text 
message, electronic mail, or an online patient portal, obtain the 
patient's verifiable affirmative consent to receive a digital copy 
through the identified method or methods, and maintain records or 
evidence of a patient's affirmative consent for a period of not less 
than three years.
    The small entities potentially covered by these amendments will 
include all such entities subject to the Rule. The professional skills 
necessary for compliance with the Rule as modified will include office 
and administrative support supervisors to create the language and 
format of the confirmation, and clerical personnel to collect 
signatures from patients and maintain records, or in the case of 
digital prescriptions, retain evidence that the prescription was sent, 
received, or made accessible, downloadable and printable and retain 
evidence of a patient's affirmative consent. Compliance may include 
some minimal training time as well. The Commission has provided 
language that prescribers can use for the Confirmation of Prescription 
Release which, should a prescriber elect to use such language, negates 
the burden of formulating appropriate language. The Commission believes 
the overall burden imposed on small businesses by these requirements is 
relatively small, for the reasons described previously in Section 
II.C.7. of this notice. That section also addresses in detail the 
comments received, which discuss the burden from this amendment.
    The amendment relating to providing a designated agent with an 
additional copy of a prescription requires that the prescriber respond 
within forty business hours of receipt of the request, and note in the 
patient's record the name of the requester and the date and time that 
the prescription was provided to the requester. The professional skills 
necessary for compliance with this amendment will include office and 
administrative support staff to respond to the request within forty 
business hours. Previously, office and administrative support staff 
were already required to respond to such requests, just not within a 
specific time frame. The forty-business-hour time period, in and of 
itself, should not impose a significant new burden. The office and 
administrative support staff will also need to make the required 
notations in the patient's records. As noted, the required notation 
would be limited to the name of the requester and the date and time the 
prescription was provided to the requester. Although the Rule does not 
require that prescribers retain the notations, the Commission expects 
prescribers would make and retain such notations in the ordinary course 
of their business and thus believes the proposal would not create much, 
if any, additional burden.
2. Amendments Affecting Sellers
    To the extent, if any, that non-prescriber sellers are small 
entities, the amendments relating to changes in verifications made 
through automated telephone messages require sellers to record the 
entire call, commence the call by identifying it as a request for 
prescription verification made in accordance with the Rule, deliver the 
information in a slow and deliberate manner and at a reasonably 
understandable volume, and make the information repeatable at the 
prescriber's option. Sellers must retain the complete call recording of 
such automated telephone messages for at least three years.
    The Commission believes that most small sellers who are covered by 
the Rule, if any, are unlikely to have undergone or to undergo the 
expense associated with creating and maintaining an automated telephone 
system for verification requests.\625\ Instead, the Commission believes 
that small sellers typically comply with the Rule by receiving copies 
of prescriptions from patients, or making verification requests to 
prescribers via fax, email, or telephone calls using ``live'' agents. 
If a small seller already has an automated system for verification, the 
Commission does not believe the costs to accommodate the changes would 
be more than minimal, if any. For a seller who was following the FTC's 
prior guidance that automated messages be delivered at a volume and 
cadence that a reasonable person can understand,\626\ it already 
complies with the new proposal that all such messages be at a 
``reasonably understandable volume'' and delivered in a ``slow and 
deliberate manner.'' Similarly, if not already in compliance, a seller 
might need to modify its model verification recording to identify at 
the start that a call is being made in accordance with the Contact Lens 
Rule and to make the required information repeatable at the 
prescriber's option.
---------------------------------------------------------------------------

    \625\ 1-800 CONTACTS also believes this to be the case. See 1-
800 CONTACTS (SNPRM Comment #135) (stating that the number of 
sellers that use this particular technology is likely limited).
    \626\ Prior guidance from the FTC directed sellers to deliver 
verification messages at a volume and cadence that a reasonable 
person can understand. See note 301, supra.
---------------------------------------------------------------------------

    The Commission also has little reason to believe that the new 
requirement that sellers who use automated messages record such calls 
and retain them for no less than three years creates a substantial 
burden for small sellers. The Commission's SNPRM invited comment on the 
frequency with which small sellers use automated telephone messages for 
verification and the costs associated with the proposals pertaining to 
these messages, including whether existing verification systems include 
the capability to record and the capacity for storage, and the costs 
associated with recording the calls and maintaining the recordings for 
no less than three years. The Commission received little guidance in 
response. 1-800 CONTACTS, a large contact lens seller, stated the 
proposal to record and store these calls imposes a ``costly'' burden, 
but did not detail the costs associated with recording and maintaining 
the calls. The Commission's own research surrounding such costs for 
recording phone calls does not support this contention.\627\ And as 
noted above, the

[[Page 50715]]

number of sellers that employ this technology is limited, and the 
Commission does not believe that small sellers use or are likely to use 
automated messages for verification calls.
---------------------------------------------------------------------------

    \627\ See PRA discussion of the cost of recording calls, Section 
XI.B., supra.
---------------------------------------------------------------------------

    The new requirement that sellers provide a method, and a clear and 
prominent disclosure of the method, for the consumer to present the 
seller with a copy of the patient's prescription also does not impose a 
large burden on small sellers. A small seller would need to update its 
website or other consumer interface to inform consumers about the 
ability to provide the seller with a prescription, or alternatively, if 
an order occurs via telephone or in person, to verbally inform the 
consumer about the ability to provide the seller with a prescription. 
The professional skill or time necessary for this task would include 
personnel with the skills required to update the website or other 
consumer interface, and the time it takes to make the updates, or if 
the information is relayed over the phone or in person, the additional 
time for an employee or agent of the seller to inform a consumer that 
he or she is able to provide a prescription, and of the method by which 
a consumer can do so. These proposals may also require training time 
for staff. The seller would also need to provide a mechanism for a 
consumer to provide the prescription to the seller. Because a small 
seller almost certainly already has the capacity to accept 
prescriptions via an existing electronic system or email account, the 
Commission believes there is little additional burden of complying with 
this part of the proposal.
    The small seller would also need to maintain prescriptions it 
receives via patient presentation. The Commission has not received any 
comments that alter its understanding that such retention does not 
create more than a minimal burden. Further, by retaining a patient's 
prescription, a seller is relieved of the burden to verify that 
prescription or maintain records of verification. As a result, the 
burden from obtaining and retaining prescriptions likely offsets the 
burden from making verification requests and storing records of such 
requests.
    Both the FCLCA and the Rule prohibit illegal alteration of a 
prescription. The modification of the Rule's definition of alteration 
would clarify what constitutes alteration, and permit sellers to avail 
themselves of an exception by verifying only the contact lens brand or 
manufacturer that consumers indicate is on their prescriptions when 
asked by the seller. As a result, all non-prescriber sellers that 
qualify as small businesses would need to request and obtain 
manufacturer or brand information via website or other consumer 
interface, telephone, or in person to qualify for the exception. The 
professional skill or time necessary for this task would include 
personnel with the skills required to update the website or other 
consumer interface and the time it takes to make the updates, or if the 
information is relayed over the phone or in person, the additional time 
for an employee or agent of the seller to obtain the information. Such 
employees would also need to be trained on this requirement.
    Although there is no associated document retention requirement set 
forth in the Rule, the Commission is aware that without the evidence 
that the manufacturer or brand provided on the verification request was 
the one provided by the customer, the seller would not be able to avail 
itself of the exception to illegal alteration. As a result, the 
Commission has considered the associated document retention as a new 
burden. However, since many contact lens sales by non-prescriber 
sellers occur online, the burden of such record retention may be 
minimized by the ability to keep electronic sales records. For sales 
that occur via telephone or in person, the seller would be required to 
maintain records of the request made by, and the information supplied 
by, the consumer. The Commission believes that sellers retain phone-
order records in the ordinary course of business and any additional 
recordkeeping sellers may do to qualify for the exception is likely to 
be minimal.

E. Steps Taken To Minimize the Significant Impact, if Any, of the 
Amendments, Including Why Any Significant Alternatives Were Not Adopted

1. Steps and Alternatives for Amendments Affecting Prescribers
    The Commission considered a number of alternatives to the 
requirement for prescribers to request the patient sign a confirmation 
of receipt of a contact lens prescription, including signage and 
educating consumers about their rights to a contact lens prescription. 
The Commission determined that signage would be significantly less 
effective than a Confirmation of Prescription Release requirement. It 
also determined that consumer education in itself, whether provided via 
information entry forms, a patients' bill of rights, advertising, or 
public service announcements, would not have a significant impact on 
prescriber compliance with automatic prescription release, and would 
not increase the Commission's ability to monitor and enforce the 
Rule.\628\ In response to commenter concerns about its proposal as 
outlined in the NPRM and SNPRM, the Commission took steps to minimize 
the impact of the Confirmation of Prescription Release. First, the 
Commission included an option for prescribers to satisfy the 
confirmation by releasing the prescription electronically. While not 
every prescriber will be able to use this option to deliver a 
prescription electronically, the Commission is confident that this 
option will still reduce the burden for many, especially as more 
prescribers move toward electronic recordkeeping. Second, the 
Commission excluded from the requirement eye care prescribers who have 
no direct or indirect financial interest in the sale of contact lenses. 
By more narrowly targeting the requirement to only those with an 
incentive to withhold prescriptions, the Commission further reduced the 
overall burden and avoided unnecessarily impacting prescribers who are 
unlikely to violate the Rule. Third, the Commission reduced the burden 
by allowing a significant degree of flexibility in how prescribers 
comply with the confirmation requirement. The Final Rule allows 
prescribers to craft their own wording for statements confirming 
receipt of contact lens prescriptions (on a stand-alone statement, on a 
prescriber-retained copy of a prescription, or on a prescriber-retained 
copy of an examination receipt), while providing sample language for 
prescribers to use, should they not wish to formulate their own 
confirmation. This change reduces the possible paperwork burden and 
limits potential interference with the prescriber-patient 
relationship.\629\
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    \628\ These alternatives and the reasons the Commission found 
them to be insufficient alternatives to Confirmation of Prescription 
Release are more fully described in Section II.C.6., supra, of this 
notice.
    \629\ In the Final Rule, for instances where a patient refuses 
to sign the confirmation, the Commission directs the prescriber to 
note the refusal and preserve this record as evidence of compliance.
---------------------------------------------------------------------------

    In considering the amendment requiring prescribers to respond to 
requests for copies of a prescription within a defined period (forty 
business hours), the Commission considered, but rejected, the option to 
simply rely on the expectation that all prescribers would fulfill their 
responsibilities to their patients. It is the Commission's 
understanding that prescribers do not always comply, or comply 
expediently, and therefore believes the time-limit requirement is 
necessary. In order to minimize the burden on prescribers, however, the 
Commission rejected

[[Page 50716]]

commenter requests to make the time limit significantly shorter, such 
as eight business hours. As for the new requirement that prescribers 
make a notation in the patient's record when responding to such 
requests, the Commission declined to shift the recordkeeping burden to 
the designated agent making a request because, to determine whether a 
particular prescriber is complying with the Rule, the Commission would 
need to obtain records from a wide variety of agents.
2. Steps and Alternatives for Amendments Affecting Sellers
    The Commission did not consider specific alternatives to the Final 
Rule's requirement that sellers, when using automated telephone 
messages to verify prescriptions, commence the call by identifying it 
as a request for prescription verification made in accordance with the 
Contact Lens Rule, deliver the required information in a slow and 
deliberate manner and at a reasonably understandable volume, and make 
the required information repeatable at the prescriber's option.\630\ 
The Commission included these amendments in the Final Rule to relieve 
the burden on prescribers and reduce potential health risks to patients 
from incomplete or incomprehensible automated telephone messages. 
Specifically, the Commission noted that prescribers must be able to 
understand automated messages so they can, if necessary, respond to 
sellers to prevent improper sales. Commenters presented additional 
suggestions to improve call quality, but did not suggest alternatives 
to commencing the call by identifying it as a request for prescription 
verification made in accordance with the Contact Lens Rule, and to make 
the required information repeatable at the prescriber's option, nor did 
they express opposition to such requirements.
---------------------------------------------------------------------------

    \630\ The requirements that the seller deliver the required 
information in a slow and deliberate manner and at a reasonably 
understandable volume have been part of the FTC's prior guidance 
that the information be delivered at a volume and cadence that a 
reasonable person can understand.
---------------------------------------------------------------------------

    The Commission considered whether to require sellers to retain a 
sample recording of the standard script leaving blanks for prescription 
and patient details instead of recording all calls using automated 
telephone messages. However, the Commission determined that a script or 
a sample recording would not reveal whether the required information 
was transmitted effectively or if, for instance, it was transmitted 
before a representative or machine answered, after an answering machine 
cut off, when a prescriber's office put the call on hold, or over hold 
music, in which case the call could not be used as a basis for the 
sale. In addition, a script or sample recording would not permit the 
Commission to assess whether a particular call was delivered in a 
``slow and deliberate manner'' and at a ``reasonable understandable 
volume.'' Without knowing this information, the Commission would be 
unable to determine conclusively whether any particular verification 
request was valid. Therefore, the Commission did not adopt this 
recommendation.
    With respect to the requirement that sellers accept prescription 
presentation, the Commission did not receive any comments opposing this 
proposal, and thus did not consider alternatives. In response to 
commenter concerns, however, the Commission determined not to permit 
sellers to select any method of communication, but opted instead to 
maximize the benefits from the amendment by requiring the seller to 
present the prescription through the same medium by which the order is 
placed, or electronic mail, text message, or file upload.
    For verification requests, the Commission expressly defined 
alteration as occurring when sellers provide prescribers with the name 
of a manufacturer or brand other than that specified on a patient's 
prescription. However, the Commission provided an exception such that 
it would not amount to alteration in instances when sellers verify only 
the contact lens brand or manufacturer that consumers indicate is on 
their prescriptions after a seller requests that information. As 
possible alternatives to these changes, the Commission considered 
whether it could instead rely on the new requirements that sellers (a) 
provide a method for prescription presentation and (b) meet quality 
standards for verification calls, but the Commission determined that 
those requirements alone are inadequate to curb the practice of 
unlawful substitution to non-prescribed brands through abuse of the 
verification system. Although the Commission has previously stated that 
a verification request is not valid and does not commence the eight-
business-hour verification period if a seller knows or should know that 
the verification request includes a different brand and manufacturer 
than that prescribed, the FTC continues to receive reports about the 
proliferation of passive verification abuses, and sellers ``gaming the 
system'' to substitute a different brand or manufacturer. Furthermore, 
without the changes to the definition of alteration, sellers may argue 
that they are technically compliant with the Rule because they 
submitted verification requests and prescribers had an opportunity to 
respond to the requests, and may also argue that they did not have 
knowledge that a consumer did not have a prescription for that 
manufacturer or brand of lens. The Final Rule amendment will give them 
a basis of knowledge by requesting that a consumer state the brand or 
manufacturer of her brand of lens. Additionally, the Commission 
determined that without the express definition of alteration and the 
exception thereto, enforcement would not, in and of itself, be adequate 
to protect consumers, because alteration via abuse of the verification 
system does not occur with only one bad actor, and because of an 
increase in companies that appear to alter prescriptions in this way.
    Seller 1-800 CONTACTS also commented that the amendment should not 
refer to ``brand'' as that language does not appear elsewhere in the 
Rule. It pointed out that the Rule defines a prescription as including 
a ``material or manufacturer or both'' and that the Commission's 
inclusion of the reference to brand imposes an additional limit on 
consumer choice that is not required by the Act. 1-800 CONTACTS 
requested that the exception to the Rule be applicable to ``providing 
the prescriber with the name of a manufacturer or material other than 
that specified by the patient's prescriber . . . .'' The reference to 
brand in the definition of alteration and in the exception are the only 
references to brand in the Rule. However, because many, if not most, 
prescriptions list the manufacturer's brand, not the manufacturer or 
material, and very few consumers know the manufacturer or material of 
contact lens that they wear (typically referring to their lenses by 
brand name), the Commission declines to follow 1-800 CONTACTS' 
recommendation because many consumers would be unable to respond to a 
seller's request.
    1-800 CONTACTS expressed concern that the Commission's amendment 
might interfere with its ability to improve the user experience. It 
indicated that it sells hundreds of brands of lenses and offers 
consumers a variety of methods to identify their brand, including drop-
down menus, a search box, and filters that display lenses by brand, 
modality, and other parameters and that some consumers do not enter 
their brand information on an order form. In response, the Commission, 
in the Final Rule, removed the language from its earlier proposal that 
sellers must obtain the information

[[Page 50717]]

on ``an order form.'' In comparison, other commenters requested greater 
specificity or even prohibitions on the acceptable mechanisms for 
sellers to request and consumers to select their brand. In response, 
the Commission clarified that, at a minimum, in order for sellers to 
consider the consumer's indication of manufacturer or brand as adequate 
to qualify for the exception, the manufacturer or brand must be: (1) 
Provided in response to a seller's request for the manufacturer or 
brand listed on the consumer's prescription; and (2) an affirmative 
statement or selection by the consumer, not a preselected or prefilled 
entry.\631\
---------------------------------------------------------------------------

    \631\ See Section VI.B., supra.
---------------------------------------------------------------------------

XIII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
the Office of Information and Regulatory Affairs designated these rule 
amendments as not a ``major rule,'' as defined by 5 U.S.C. 804(2).

List of Subjects in 16 CFR Part 315

    Advertising, Medical devices, Ophthalmic goods and services, Trade 
practices.

    For the reasons discussed in the preamble, the Federal Trade 
Commission amends title 16 of the Code of Federal Regulations, part 
315, as follows:

PART 315--CONTACT LENS RULE

0
1. The authority for part 315 is revised to read as follows:

    Authority: 15 U.S.C. 7601-7610.

0
2. Amend Sec.  315.2 by adding in alphabetical order the definitions of 
``Provide to the patient a copy'', ``Reasonably understandable volume'' 
and ``Slow and deliberate manner'' to read as follows:


Sec.  315.2  Definitions.

* * * * *
    Provide to the patient a copy means giving a patient a copy of his 
or her contact lens prescription:
    (1) On paper; or
    (2) In a digital format that can be accessed, downloaded, and 
printed by the patient. For a copy provided in a digital format, the 
prescriber shall identify to the patient the specific method or methods 
of electronic delivery to be used, such as text message, electronic 
mail, or an online patient portal, and obtain the patient's verifiable 
affirmative consent to receive a digital copy through the identified 
method or methods; and maintain records or evidence of a patient's 
affirmative consent for a period of not less than three years. Such 
records or evidence shall be available for inspection by the Federal 
Trade Commission, its employees, and its representatives.
    Reasonably understandable volume means at an audible level that 
renders the message intelligible to the receiving audience.
    Slow and deliberate manner means at a rate that renders the message 
intelligible to the receiving audience.

0
3. Amend Sec.  315.3 by:
0
a. Revising paragraphs (a)(1) and (2);
0
b. Adding paragraph (a)(3);
0
c. Revising paragraphs (b)(1) through (3); and
0
d. Adding paragraph (c).
    The additions and revisions read as follows:


Sec.  315.3  Availability of contact lens prescriptions to patients.

    (a) In general. When a prescriber completes a contact lens fitting, 
the prescriber:
    (1) Whether or not requested by the patient, shall provide to the 
patient a copy of the contact lens prescription;
    (2) Shall, as directed by any person designated to act on behalf of 
the patient, verify the contact lens prescription by electronic or 
other means; and
    (3) Shall, upon request, provide any person designated to act on 
behalf of the patient with a copy of the patient's contact lens 
prescription by electronic or other means within forty (40) business 
hours of receipt of the request. A prescriber shall note in the 
patient's record the name of the requester and the date and time that 
the prescription was provided to the requester.
    (b) Limitations. A prescriber may not:
    (1) Require the purchase of contact lenses from the prescriber or 
from another person as a condition of providing a copy of a 
prescription under paragraph (a)(1) or (a)(3) of this section or as a 
condition of verification of a prescription under paragraph (a)(2) of 
this section;
    (2) Require payment in addition to, or as part of, the fee for an 
eye examination, fitting, and evaluation as a condition of providing a 
copy of a prescription under paragraph (a)(1) or (a)(3) of this section 
or as a condition of verification of a prescription under paragraph 
(a)(2) of this section; or
    (3) Require the patient to sign a waiver or release as a condition 
of releasing or verifying a prescription under paragraph (a)(1), 
(a)(2), or (a)(3) of this section.
    (c) Confirmation of prescription release. (1)(i) Upon completion of 
a contact lens fitting, the prescriber shall do one of the following:
    (A) Request that the patient acknowledge receipt of the contact 
lens prescription by signing a statement confirming receipt of the 
contact lens prescription;
    (B) Request that the patient sign a prescriber-retained copy of a 
contact lens prescription that contains a statement confirming receipt 
of the contact lens prescription;
    (C) Request that the patient sign a prescriber-retained copy of the 
receipt for the examination that contains a statement confirming 
receipt of the contact lens prescription; or
    (D) If a digital copy of the prescription was provided to the 
patient (via methods including an online portal, electronic mail, or 
text message) in compliance with paragraph (a)(1) of this section, 
retain evidence that the prescription was sent, received, or made 
accessible, downloadable, and printable.
    (ii) If the prescriber elects to confirm prescription release via 
paragraphs (c)(1)(i)(A), (B), or (C) of this section, the prescriber 
may, but is not required to, use the statement, ``My eye care 
professional provided me with a copy of my contact lens prescription at 
the completion of my contact lens fitting'' to satisfy the requirement.
    (iii) In the event the patient declines to sign a confirmation 
requested under paragraph (c)(1)(i)(A), (B), or (C) of this section, 
the prescriber shall note the patient's refusal on the document and 
sign it.
    (2) A prescriber shall maintain the records or evidence required 
under paragraph (c)(1) of this section for a period of not less than 
three years. Such records or evidence shall be available for inspection 
by the Federal Trade Commission, its employees, and its 
representatives.
    (3) Paragraphs (c)(1) and (c)(2) of this section shall not apply to 
prescribers who do not have a direct or indirect financial interest in 
the sale of contact lenses, including, but not limited to, through an 
association, affiliation, or co-location with a contact lens seller.

0
4. Amend Sec.  315.5 by:
0
a. Redesignating paragraphs (d), (e), (f), and (g) as paragraphs (e), 
(f), (h), and (i), respectively;
0
b. Adding new paragraph (d);
0
c. Revising newly redesignated paragraph (f);
0
d. Adding new paragraph (g);
0
e. Adding new paragraph (h)(2)(iii);
0
f. Revising newly redesignated paragraph (i).
    The additions and revisions read as follows:

[[Page 50718]]

Sec.  315.5  Prescriber verification.

* * * * *
    (d) Automated telephone verification messages. If a seller verifies 
prescriptions through calls that use, in whole or in part, an automated 
message, the seller must:
    (1) Record the entire call;
    (2) Commence the call by identifying it as a request for 
prescription verification made in accordance with the Contact Lens 
Rule;
    (3) Deliver the information required by paragraph (b) of this 
section in a slow and deliberate manner and at a reasonably 
understandable volume; and
    (4) Make the information required by paragraph (b) of this section 
repeatable at the prescriber's option.
* * * * *
    (f) No alteration of prescription. A seller may not alter a contact 
lens prescription. In the context of prescription verification, 
alteration includes, but is not limited to, providing the prescriber 
with the name of a manufacturer or brand other than that specified by 
the patient's prescription, unless such name is provided because the 
patient entered or orally provided it when asked for the manufacturer 
or brand listed on the patient's prescription. Notwithstanding the 
preceding sentences, for private label contact lenses, a seller may 
substitute for contact lenses specified on a prescription identical 
contact lenses that the same company manufactures and sells under 
different labels.
    (g) Seller requirement to accept prescription presentation: A 
seller shall provide a prominent method, and a clear and prominent 
disclosure of that method, for the patient to present the seller with a 
copy of the patient's prescription. Such method and the disclosure 
shall be provided prior to requesting a prescriber's contact 
information for verification of the prescription; provided, however, in 
the case of an order placed by telephone, a seller shall comply by 
providing a disclosure of the method prior to requesting a prescriber's 
contact information for verification of the prescription. The method to 
present the prescription shall be provided through (i) the same medium 
by which the order is placed, or (ii) electronic mail, text message, or 
file upload.
    (h) * * *
    (2) * * *
    (iii) If the communication occurs via telephone and uses an 
automated message, the complete recording required pursuant to 
paragraph (d)(1) of this section.
* * * * *
    (i) Recordkeeping requirement--Saturday business hours. A seller 
that exercises its option to include a prescriber's regular Saturday 
business hours in the time period for a request for a copy of the 
prescription specified in Sec.  315.3(a)(3) or for verification 
specified in paragraph (c)(3) of this section shall maintain a record 
of the prescriber's regular Saturday business hours and the basis for 
the seller's actual knowledge thereof. Such records shall be maintained 
for a period of not less than three years, and these records must be 
available for inspection by the Federal Trade Commission, its 
employees, and its representatives.

    By direction of the Commission.
April J. Tabor,
Secretary.
[FR Doc. 2020-14206 Filed 8-14-20; 8:45 am]
BILLING CODE 6750-01-P