Contact Lens Rule, 88526-88559 [2016-28471]

Download as PDF 88526 Federal Register / Vol. 81, No. 235 / Wednesday, December 7, 2016 / Proposed Rules FEDERAL TRADE COMMISSION 16 CFR Part 315 RIN 3084–AB36 Contact Lens Rule Federal Trade Commission (‘‘FTC’’ or ‘‘Commission’’). ACTION: Notice of proposed rulemaking; request for public comment. AGENCY: As part of its regulatory review of the Contact Lens Rule (‘‘Rule’’), and consistent with the requirements of the Fairness to Contact Lens Consumers Act (the ‘‘Act’’), the Federal Trade Commission proposes to amend the Rule to require that prescribers obtain a signed acknowledgment after releasing a contact lens prescription to a patient, and maintain each such acknowledgment for a period of not less than three years. The Commission seeks comment on this proposal and several other issues. DATES: Written comments must be received on or before January 30, 2017. ADDRESSES: Interested parties may file a comment online or on paper by following the instructions in the Request for Comment part of the SUPPLEMENTARY INFORMATION section below. Write ‘‘Contact Lens Rule, 16 CFR part 315, Project No. R511995’’ on your comment, and file your comment online at https://ftcpublic.comment works.com/ftc/contactlensrule by following the instructions on the webbased form. If you prefer to file your comment on paper, write ‘‘Contact Lens Rule, 16 CFR part 315, Project No. R511995’’ on your comment and on the envelope and mail your comment to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW., Suite CC–5610 (Annex C), Washington, DC 20580, or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW., 5th Floor, Suite 5610 (Annex C), Washington, DC 20024. FOR FURTHER INFORMATION CONTACT: Elizabeth Delaney, Attorney, (202) 326– 2903, or Paul Spelman, Attorney, (202) 326–2487, Division of Advertising Practices, Bureau of Consumer Protection, Federal Trade Commission, 600 Pennsylvania Avenue NW., Washington, DC 20580. SUPPLEMENTARY INFORMATION: asabaliauskas on DSK3SPTVN1PROD with PROPOSALS SUMMARY: Table of Contents I. Background A. Overview of the Contact Lens Rule VerDate Sep<11>2014 20:36 Dec 06, 2016 Jkt 241001 B. Regulatory History C. The Evolving Contact Lens Marketplace II. Contact Lens Rule Review III. Availability of Contact Lens Prescriptions to Patients A. Section 315.3(a)(1)—Automatic Prescription Release 1. Compliance With the Automatic Prescription Release Requirement 2. Commenter Suggestions for Improving Automatic Prescription Release Compliance 3. Analysis of Proposals for Improving Automatic Prescription Release Compliance and Commission Proposal (a) Proposal To Increase Enforcement (b) Proposal To Require an Eye Care Patients’ Bill of Rights or Notice-UponCheck-In (c) Proposal To Require a Signed Acknowledgment Form (d) Proposal To Require Signage (e) The Commission’s Proposal To Require a Signed Acknowledgment 4. Additional Mechanisms for Improving Prescription Portability B. Section 315.3(a)(1)—Additional Copies of Prescriptions C. Section 315.3(a)(2)—Provide or Verify the Contact Lens Prescription 1. Sellers Designated To Act on Behalf of Patients IV. Prescriber Verification A. Section 315.5(a)—Prescription Requirement 1. Presentation of Prescriptions ‘‘Directly or By Facsimile’’ 2. ‘‘Verified by Direct Communication’’ 3. Automated Telephone Calls as a Method of Direct Communication B. Section 315.5(b)—Information for Verification 1. Vendor Contact Information 2. Prescribers’ Selection of Communication Mechanism C. Section 315.5(c)—Verification Events 1. Passive Verification 2. Issues Regarding the Eight-BusinessHour-Window V. Contact Lens Prescriptions A. Section 315.6—Expiration of Contact Lens Prescriptions 1. Length of Contact Lens Prescriptions 2. Expired Contact Lens Prescriptions 3. Quantities of Contact Lenses Obtained by Patients B. Private Label Lenses and Contact Lens Substitution 1. Private Label Lenses 2. Alteration of Contact Lens Prescriptions by Sellers C. HIPAA Issues D. Enforcement Efforts E. Recommendations Regarding the Commission’s Complaint Reporting System VI. Request for Comment VII. Communications by Outside Parties to the Commissioners or Their Advisors VIII. Paperwork Reduction Act A. Estimated Additional Hours Burden B. Estimated Total Labor Cost Burden IX. Regulatory Flexibility Act A. Description of the Reasons the Agency Is Taking Action B. Statement of the Objectives of, and Legal Basis for, the Proposed Amendments PO 00000 Frm 00002 Fmt 4701 Sfmt 4702 C. Small Entities to Which the Proposed Amendments Will Apply D. Projected Reporting, Recordkeeping, and Other Compliance Requirements, Including Classes of Covered Small Entities and Professional Skills Needed To Comply X. Proposed Rule Language I. Background A. Overview of the Contact Lens Rule In 2003, Congress enacted the Fairness to Contact Lens Consumers Act,1 and pursuant to the Act, the Commission promulgated the Contact Lens Rule on July 2, 2004.2 The Rule went into effect on August 2, 2004. The Contact Lens Rule promotes competition in retail sales of contact lenses by facilitating consumers’ ability to comparison shop for contact lenses. When a prescriber completes a contact lens fitting, the Rule requires that the prescriber provide the patient with a portable copy of her prescription. The Rule also requires that the prescriber verify or provide such prescriptions to authorized third parties. At the same time, the Rule requires that contact lens vendors only sell contact lenses in accordance with valid prescriptions written by licensed prescribers. The Rule specifies that a prescriber may not require: (1) The purchase of contact lenses as a condition of providing the prescription or verification; (2) payment in addition to, or as a part of, the fee for an eye examination, fitting, and evaluation as a condition of providing the prescription or verification; or (3) the patient to sign a waiver or release as a condition of releasing or verifying the prescription.3 The prescriber is also prohibited from requiring immediate payment before the release of a prescription, unless the prescriber requires immediate payment when an exam reveals that the consumer does not need ophthalmic goods.4 The Rule also places certain requirements on sellers. It mandates that sellers dispense contact lenses only in accordance with a valid prescription that is either presented to the seller or verified by direct communication with the prescriber.5 The Rule sets out the information that must be included in a seller’s verification request, and directs that a prescription is only verified under the Rule if: (1) A prescriber confirms the prescription is accurate; (2) a prescriber informs the seller that the prescription is inaccurate and provides an accurate 1 15 U.S.C. 7601–7610 (Pub. L. 108–164). Lens Rule, 16 CFR 315 (2015). 3 16 CFR 315.3(b). 4 16 CFR 315.4. 5 16 CFR 315.5(a). 2 Contact E:\FR\FM\07DEP2.SGM 07DEP2 Federal Register / Vol. 81, No. 235 / Wednesday, December 7, 2016 / Proposed Rules 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 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 Sellers and others involved in the manufacture, assembly, processing, and distribution of contact lenses are prohibited from representing that contact lenses may be obtained without a prescription.9 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.10 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.11 B. Regulatory History The FTC has more than three decades of regulatory and research experience regarding the optical goods industry. In addition to the Contact Lens Rule, the Commission enforces the Ophthalmic Practice Rules (hereinafter ‘‘Eyeglass Rule’’), initially promulgated in 1978.12 Prior to the Eyeglass Rule, many prescribers either refused to release prescriptions to their patients or charged an additional fee to do so.13 Prices for glasses varied widely, but 6 16 CFR 315.5(b)–(c). CFR 315.5(d). 8 16 CFR 315.5(e). 9 16 CFR 315.7. 10 16 CFR 315.6. 11 16 CFR 315.11(a). The Rule states further that ‘‘[a]ny other state or local laws or regulations that are inconsistent with the Act or this part are preempted to the extent of the inconsistency.’’ 16 CFR 315.11(b). 12 Advertising of Ophthalmic Goods and Services, 43 FR 23992 (June 2, 1978). The Rule was revised in 1992, with the revisions codified at 16 CFR 456. Ophthalmic Practice Rules, 57 FR 18822 (May 1, 1992). 13 43 FR at 23998. The Commission found, for example, that in nearly every survey of practicing optometrists considered in the rulemaking record, more than 50% of optometrists imposed a restriction on the availability of eyeglass prescriptions to patients. See id. asabaliauskas on DSK3SPTVN1PROD with PROPOSALS 7 16 VerDate Sep<11>2014 20:36 Dec 06, 2016 Jkt 241001 without their prescriptions, or without paying a fee to obtain their prescriptions, consumers could not comparison shop among prescribers and other vendors and purchase from sellers that best met their needs for price, service, and convenience.14 Moreover, competition did not lead the industry to offer what consumers could not choose: when consumers’ ability to comparison shop is diminished, the normal competitive pressures on the eye care industry to offer competitive prices—or the combination of prices, features, and services most in demand—are themselves diminished. To address this problem, the Eyeglass Rule requires 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 Consumers, sellers, and state officials complained that contact lens consumers faced similar hurdles when trying to comparison shop for contact lenses.16 To achieve freedom of choice and the benefits of competition for contact lens consumers, in 2003, Congress passed the Fairness to Contact Lens Consumers Act,17 and as the Act required, in 2004, 14 Fed. Tr. Comm’n, ‘‘The Strength of Competition in the Sale of Rx Contact Lenses: An FTC Study,’’ 45–46 (2005), http://www.ftc.gov/reports/ contactlens/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 Fed. Tr. Comm’n, Bureau of Economics Staff Paper, ‘‘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 For example, in In re Disposable Contact Lens Antitrust Litigation, the Attorneys General of 31 states and a certified class alleged that eye care professionals engaged in an organized effort to prevent or hinder consumers from obtaining their contact lens prescriptions. In re Disposable Contact Lens Antitrust Litigation, No. 94–MDL 1030–J–20A (M.D. Fla.). 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 complaints, 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, defendant manufacturers agreed to sell contact lenses to alternative distribution channels. 17 15 U.S.C. 7601–7610 (Pub. L. 108–164). PO 00000 Frm 00003 Fmt 4701 Sfmt 4702 88527 the Commission issued the Contact Lens Rule,18 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,19 the Act requires that contact lenses be sold only to patients with valid prescriptions, which they receive after contact lens fittings. As noted above, the Act and the Contact Lens Rule only allow sales of contact lenses when the seller has a copy of the patient’s prescription or has verified that prescription with the prescriber.20 Sellers also are prohibited from altering a contact lens prescription.21 The U.S. Food and Drug Administration (‘‘FDA’’) has strict labeling requirements for contact lenses, and it has the authority to take action against the sales of such lenses, which are medical devices, without a valid prescription.22 Because of concerns that many prescribers had impeded consumers’ ability to comparison shop for contact lenses—even following appropriate diagnosis and fitting by the prescribers—the Act and the Rule also impose obligations on the prescribers themselves. As noted above, prescribers are required to release a copy of the prescription to the consumer, promptly upon completion of the contact lens fitting, ‘‘[w]hether or not requested by the patient.’’ 23 That copy must be complete and portable to enable comparison shopping: it must contain ‘‘sufficient information for the complete and accurate filling of a prescription.’’ 24 Prescribers also are prohibited from requiring the purchase of contact lenses as a condition of either prescription release or verification, from requiring a separate payment for prescription release or verification, and from requiring that the patient sign a waiver as a condition of prescription release or verification.25 Prescribers also are required to provide or verify a contact lens 18 Contact Lens Rule, 69 FR 40482 (July 2, 2004) (codified at 16 CFR 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. 19 See, e.g., Fed. Tr. Comm’n, ‘‘Possible Barriers to E-Commerce: Contact Lenses, A Report from the Staff of the Federal Trade Commission,’’ 8–9 (Mar. 2004), http://www.ftc.gov/os/2004/03/ 040329clreportfinal.pdf [hereinafter 2004 Possible Barriers to E-Commerce Report]. 20 16 CFR 315.5(a). 21 16 CFR 315.5(e). 22 See 21 U.S.C. 331(a), 333, 352(f), and 353(b)(1). 23 15 U.S.C. 7601(a)(1); 16 CFR 315.3(a)(1). 24 15 U.S.C. 7610(3); 16 CFR 315.2. 25 15 U.S.C. 7601(b)(1)–(3); 16 CFR 315.3(b)(1)– (3). E:\FR\FM\07DEP2.SGM 07DEP2 88528 Federal Register / Vol. 81, No. 235 / Wednesday, December 7, 2016 / Proposed Rules prescription when ‘‘directed by any person designated to act on behalf of the patient.’’ 26 Sales of contact lenses require a valid prescription that is verified by a prescriber. Such verification takes place: (1) When the prescriber confirms that the prescription is accurate, by phone, facsimile, or electronic mail; (2) when the prescriber informs the seller that the prescription is inaccurate and provides the correct prescription; or (3) when the seller seeks verification of a given prescription from a prescriber, and the prescriber does not communicate with the seller within eight business hours of the seller’s request for information.27 This eighthour, default ‘‘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—simply by refusing to respond to verification requests. asabaliauskas on DSK3SPTVN1PROD with PROPOSALS C. The Evolving Contact Lens Marketplace When contact lenses were first introduced, they were made of rigid material that required a prescriber to custom fit each pair. Beginning in the late 1980s, manufacturers began to sell disposable lenses, designed to be replaced on a daily, weekly, or monthly basis. In addition, technological advances resolved most lensstandardization issues, eliminating the need for a prescriber to fit each pair to the individual once the initial prescription had been finalized. Today, the vast majority of replacement lenses bought pursuant to an individual’s prescription will be identical, regardless of whether the patient purchases them from the prescriber or a third-party seller.28 This enables the sale of lenses to be unbundled from the fitting exam, and makes it feasible for non-prescribers to sell contact lenses. These technological advances have increased the comfort and convenience of contact lenses, leading to growth in the number of contact lens wearers, and changes in the type and variety of lenses worn. According to the U.S. Centers for 26 15 U.S.C. 7601(a)(2) (must, as directed by authorized party, ‘‘provide or verify’’ the prescription); 16 CFR 315.3(a)(2). 27 15 U.S.C. 7603(d)(1)–(3); 16 CFR 315.5. 28 However, contact lens prescriptions are brand specific, and as a general matter, one brand cannot be substituted for another, even if the other technical parameters (power, base curve, diameter, cylinder, and axis) are identical. As noted previously, sellers may substitute identical contact lenses that the same company manufactures and sells under a different name. VerDate Sep<11>2014 20:36 Dec 06, 2016 Jkt 241001 Disease Control and Prevention (‘‘CDC’’), there are now approximately 40.9 million contact lens wearers in the United States age 18 and older, representing more than 16% of the population.29 Overall, the U.S. market for contact lenses currently is estimated to be between $4 billion and $5 billion annually.30 Of that, approximately 40% of sales are made by independent eye care professionals (optometrists and ophthalmologists), 19% by conventional retail chains (such as LensCrafters, etc.), 25% from mass merchants and wholesale clubs (such as Costco, Sam’s Club, etc.), and 18% by online sellers (16% of sales are by ‘‘pure play’’ online sellers, such as 1–800 CONTACTS, that do not have a physical retail presence).31 By contrast, in 2006, the total U.S. market for contact lenses was approximately $3.3 billion, with estimated online sales representing less than 13% of the market.32 There also are significantly more types of lenses in the U.S. now than there were 10 to 15 years ago.33 At the same time, use of daily disposable lenses increased from just 7.5% in 2005 to 28% in 2015, while use of conventional one-year lenses declined sharply, from 19% to 1%.34 II. Contact Lens Rule Review On September 3, 2015, the Commission solicited comments on the Contact Lens Rule as part of its periodic review of its rules and guides.35 The 29 Jennifer R. Cope et al., ‘‘Contact Lens Wearer Demographics and Risk Behaviors for Contact LensRelated Eye Infections—United States, 2014,’’ Morb. Mortal. Wkly. Rep. 64(32):865–70, 866 (Aug. 21, 2015). See also Vision Council, ‘‘Consumer Barometer,’’ Sept. 2015 (estimating that 16.2% of American adults wear contact lenses). 30 See Vision Council, ‘‘Consumer Barometer,’’ Mar. 2014 (valuing the U.S. contact lens market at $4.2 billion); Vision Council, ‘‘Consumer Barometer,’’ Sept. 2015 (valuing the U.S. contact lens market at $4.6 billion). 31 Vision Council, ‘‘U.S. Optical Industry Report Card,’’ Dec. 2015. 32 See Vision Council, supra note 30. 33 These include, among others, soft spherical (common soft lenses), soft toric (lenses for astigmatic patients), soft multifocal (lenses for presbyotic patients), spherical corneal GP (rigid lenses for presbyotic and astigmatic patients), and scleral (lenses for patients with corneal irregularities). Furthermore, according to Johnson & Johnson Vision Care, Inc., more than 160 different brands of contact lenses are available. Comment #582. See also Jason J. Nichols, ‘‘2015 Annual Report,’’ Contact Lens Spectrum, Jan. 1, 2016, http://www.clspectrum.com/ articleviewer.aspx?articleID=113689. 34 Carla J. Mack, ‘‘Annual Report, Contact Lenses 2007,’’ Contact Lens Spectrum, Jan. 1, 2008, http:// www.clspectrum.com/ articleviewer.aspx?articleID=101240; Nichols, supra note 33. 35 Contact Lens Rule, Request for Comment, 80 FR 53272 (Sept. 3, 2015). PO 00000 Frm 00004 Fmt 4701 Sfmt 4702 Commission sought comments on: The economic impact of, and the 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. The comment period closed on October 26, 2015. This Notice of Proposed Rulemaking (‘‘NPRM’’) summarizes the comments received and explains the Commission’s decision to retain the Contact Lens Rule. It also explains why the Commission proposes certain amendments and why it declines to propose others. Additionally, it seeks comment on certain questions. Finally, the NPRM sets forth the Commission’s regulatory analyses under the Regulatory Flexibility and Paperwork Reduction Acts, as well as the text of the proposed amendments. The Commission received 660 comments from individuals and entities representing a wide range of viewpoints, including prescribing eye care practitioners (ophthalmologists and optometrists), opticians and other eyewear industry members, sellers of contact lenses (both online and brickand-mortar), contact lens manufacturers, and consumer and competition advocates.36 Virtually all commenters agreed that there is a continuing need for the Rule and that it benefits consumers and competition. The majority of commenters recommended some modifications to the Rule in order to maximize the benefits to consumers and competition, decrease the burden on businesses, protect consumers’ eye health, or improve overall compliance with the Rule’s existing requirements. Many commenters—including prescribers, sellers, manufacturers, legislators, and consumer advocates— also indicated that increased enforcement efforts would be beneficial. Some commenters—including contact lens sellers, opticians, state and federal legislators, consumer advocacy groups, and others—stated that the Act’s intent to provide a competitive marketplace is 36 The comments are posted at: https:// www.ftc.gov/policy/public-comments/initiative-621. The Commission has assigned each comment a number appearing after the name of the commenter and the date of submission. This notice cites comments using the last name of the individual submitter or the name of the organization, followed by the number assigned by the Commission. E:\FR\FM\07DEP2.SGM 07DEP2 Federal Register / Vol. 81, No. 235 / Wednesday, December 7, 2016 / Proposed Rules asabaliauskas on DSK3SPTVN1PROD with PROPOSALS not being fully realized because prescribers are not complying with one of the major underpinnings of the Rule: the automatic release of prescriptions to patients.37 Some commenters also asserted that some prescribers are interfering with the prescription verification process and thereby impeding consumers’ ability to comparison shop.38 Many commenters discussed the fact that the use of contact lenses presents certain eye health risks. Prescribers pointed out that merely by wearing contact lenses, patients will experience an increased risk for microbial keratitis (also referred to as infectious or bacterial keratitis).39 Indeed, contact lens wear has been identified as the largest single risk factor for microbial keratitis.40 Furthermore, this risk increases if a patient wears the lenses too long, wears the lenses overnight, or fails to comply with the recommended replacement schedule.41 Other commenters noted that additional risk factors for ocular complications include improper care of the lenses or poor hygiene practices.42 Other commenters pointed out that improperly fitting contact lenses may result in corneal ulcers and other health issues.43 37 See, e.g., Utah Retail Merchants Association (Comment #28); Information Technology & Innovation Foundation (Comment #40); Rhode Island State Representative Kennedy (Comment #536); Arizona State Representative Carter (Comment #545); Utah State Senator Bramble (Comment #576); Lens.com (Comment #614); Consumers Union (Comment #677). 38 See, e.g., LD Vision Group (Comment #544); National Association of Optometrists and Opticians (Comment #549); 1–800 CONTACTS (Comment #568); Warby Parker (Comment #593). 39 See, e.g., Whipple (Comment #15); Nelson (Comment #130). See also CLAO (Comment #572) (commenting that ‘‘[t]he CDC points out that the largest single risk factor for microbial keratitis is contact lens wear’’); Lupinski (Comment #499) (‘‘[s]tudies over the years have shown that wearing contact lenses increases the risk for ocular health complications’’). 40 Cope, supra note 29, at 866. 41 See id. at 867 (‘‘sleeping in any type of contact lens increases risk for eye infection’’); Fiona Stapleton, et al., ‘‘The Incidence of Contact LensRelated Microbial Keratitis in Australia,’’ Ophthalmology 2008; 115:1655, 1659 (‘‘Overnight use of [contact lenses], irrespective of material type, continues to be the main risk factor for corneal infection.’’). See also Whipple (Comment #15); Buthod (Comment #81); Morgan (Comment #144); Lupinski (Comment #499); Bearden (Comment #554). 42 See, e.g., Shlosman (Comment #290); Israel (Comment #429); Bearden (Comment #554); Barnett (Comment #668). See also CLAO (Comment #572) (citing to a recent CDC report that found outbreaks of serious eye infections among contact lens wearers continue and ‘‘are associated with failure to wear, clean, disinfect and store their lenses as directed’’). 43 See, e.g., Raykovicz (Comment #35); Morgan (Comment #144); Pusz (Comment #646); see also American Academy of Ophthalmology (Comment #611) (‘‘[w]earing improper lenses can further VerDate Sep<11>2014 20:36 Dec 06, 2016 Jkt 241001 In light of the risks associated with the use of contact lenses, many commenters—including individual prescribers, optometric and ophthalmologic associations, and contact lens manufacturers—stressed the important need to adequately protect eye health and safety and argued that the current Rule framework is not sufficient to do so.44 For example, the Contact Lens Association of Ophthalmologists, Inc. (‘‘CLAO’’) asserted that the Rule’s passive verification framework ‘‘creates a mechanism for renewal of expired prescriptions’’ and ‘‘eliminates a critical opportunity to improve the public health of contact lens consumers by addressing risky wear and care practices.’’ 45 As support, the CLAO comment cited to an article in the CDC’s weekly report recommending vigorous health promotion activities to encourage contact lens wearers to improve their hygiene behaviors.46 However, the comment did not include any empirical evidence showing that the passive verification mechanism has actually resulted in the renewal of expired prescriptions. Furthermore, the CLAO did not present any data showing that patients are not visiting their eye care practitioners as a result of the passive verification mechanism (or any other Rule provision). Other examples of patient harm identified by commenters were either hypothetical or anecdotal (such as case reports about the experiences of individual patients).47 The comments complicate existing vision issues, including leading to infection in the eye’’). 44 Commenters provided illustrations of how they believe the current operation of the Rule is jeopardizing consumer health. For example, some commenters posited that loopholes in the Rule allow patients to obtain lenses with expired, or otherwise invalid, prescriptions. According to this line of argument, patients are obtaining lenses without annual eye examinations, or without the proper medical oversight to monitor their use of contact lenses, and this could result in delayed or missed diagnosis of contact lens-related eye issues, other eye health issues, or other health conditions that otherwise would be detected during an annual eye examination. Commenters also expressed concerns that if patients do not visit eye care prescribers regularly, they will not receive proper training on the care and use of contact lenses. 45 Comment #572. See also American Optometric Association (Comment #644) (‘‘[a]llowing repurchases based on long-expired prescriptions may be, at the time, convenient for the patient and profitable for the seller, but increases the risk of patient harm’’). 46 Cope, supra note 29. 47 See, e.g., Combs (Comment #90) (patient with corneal ulcer had not been to doctor in eight years); Simmons (Comment #104) (patient ordered contacts using spectacle prescription with on online retailer; never given proper hygiene training); Mansito (Comment #122) (sister ordered lenses online with expired prescription; they did not fit and she needed corneal transplant); Ahn (Comment #215) PO 00000 Frm 00005 Fmt 4701 Sfmt 4702 88529 did not include data indicating the number or percentage of patients who obtain lenses without a valid prescription, or empirical evidence that patients are seeing their eye care practitioners less frequently than they did prior to the Rule’s adoption. In addition, while some commenters stated that patients are obtaining lenses without proper medical supervision, industry data indicates that approximately 40% of contact lenses are still obtained directly from independent prescribers, and only roughly 16% of contact lenses are obtained from onlineonly sellers, the retail venue most frequently mentioned by commenters.48 Most importantly, these commenters did not point to any evidence that the implementation of the Rule has increased the incidence of contact lens complications. Other commenters argued that contact lens sales through alternative supply channels put patients at higher risk for ocular complications. The American Academy of Optometry, for example, asserted that ‘‘careful peer reviewed research over the past ten years’’ shows that ‘‘the development of alternative supply chains for the sale of contact lenses—and the use of those alternative supply chains by contact lens patients— has itself become an identifiable risk factor for ocular morbidity in contact lens patients.’’ 49 To support this contention, this commenter cited several studies that it believes show that internet purchasers of contact lenses are more likely to engage in harmful eye care practices,50 to have a significant difference in aftercare awareness,51 and to have a higher risk of developing microbial keratitis.52 The Commission examined each of these studies and concludes that they are not sufficient to reliably demonstrate that purchasing lenses online is a risk factor, or that online purchasers are at a higher risk of developing microbial keratitis or any other ocular complication.53 (patient sleeping in lenses for a week at a time, using outdated prescription). 48 Vision Council, ‘‘U.S. Optical Industry Report Card,’’ Dec. 2015. 49 Comment #623. 50 Joshua Fogel & Chaya Zidile, ‘‘Contact lenses purchased over the Internet place individuals potentially at risk for harmful eye care practices,’’ Optometry, 79.1 (2008) 23–35. 51 Yvonne Wu et al., ‘‘Contact lens user profile, attitudes and level of compliance to lens care,’’ Cont. Lens Anterior Eye 33 (2010) 183–188. 52 Stapleton, supra note 41. 53 The Fogel and Wu studies have relatively small samples of consumers who purchased contact lenses over the Internet and the sample recruiting methodologies call into question whether the results are generalizable to the national population. In addition, the results of these studies link E:\FR\FM\07DEP2.SGM Continued 07DEP2 88530 Federal Register / Vol. 81, No. 235 / Wednesday, December 7, 2016 / Proposed Rules asabaliauskas on DSK3SPTVN1PROD with PROPOSALS Some commenters merely asserted that patient eye health is being compromised because online retailers do not comply with the Rule,54 online retailer practices have convinced consumers that contact lenses are a commodity rather than a medical device,55 and online retailers do not provide patients with proper care instructions.56 Other prescribers alleged that patients who purchase contact lenses online or through mail order companies are noncompliant with follow-up eye care and the safe use of contact lenses,57 or purchase lenses with expired prescriptions and then experience complications.58 A few commenters asserted that online purchasing in particular allows patients to obtain lenses without a valid, unexpired prescription and provided anecdotal examples of patients who avoided regular eye examinations by purchasing lenses online.59 The Commission does not find the evidence proffered in this Rule review sufficient to support a conclusion that the Rule inadequately protects consumer eye health. Commenters did not provide sufficient reliable empirical evidence that the current Rule leads to the increased acquisition of contact lenses without a valid prescription or increased incidence of contact lensrelated eye disease or adverse eye conditions. Furthermore, despite commenters’ concerns about online or mail order sales of contact lenses, the Commission has not seen reliable empirical evidence to support a finding that such sales are contributing to an purchase locations to consumer behaviors such as having a doctor check the contact lens fitting after purchase or awareness of recommended follow-up visit, rather than actual adverse eye health outcomes. The Stapleton study identified Internet/ mail order purchases as a potential risk factor for microbial keratitis in a large sample from Australia. However, when the authors of the Stapleton study limit their sample to cases of moderate to severe keratitis, Internet/mail order purchases are not found to be a risk factor. See Fiona Stapleton et al., ‘‘Risk factors for moderate and severe microbial keratitis in daily wear contact lens users,’’ Ophthalmology 2012; 119:1516–1521. 54 See, e.g., Weissman (Comment #50); Copeland (Comment #73); Anderson (Comment #96); Woodland (Comment #98); Wheeden (Comment #214); Holliday (Comment #249); Arthur (Comment #371); Blankenship (Comment #395). 55 Sancho (Comment #226). 56 Miyabe (Comment #481). 57 See, e.g., Alford (Comment #18) (stating that they have a much higher rate of adverse effects such as vision threatening eye infections and inflammatory conditions, as they usually over wear their lenses and avoid seeking eye care when they have a complication). 58 See, e.g., Owen (Comment #72); Stephens (Comment #210); Ahn (Comment #215); Born (Comment #570); King (Comment #655). 59 Gronquist (Comment #75); Buthod (Comment #81); Morgan (Comment #144); Sadeghian (Comment #242). VerDate Sep<11>2014 20:36 Dec 06, 2016 Jkt 241001 increased incidence, or increased risk, of contact lens-related eye problems.60 In addition, the particular risks associated with contact lens use (or overuse) were previously considered by Congress and the Commission during the passage of the Act and the implementation of the Rule.61 The current rulemaking record does not provide any basis to disrupt this original analysis. III. Availability of Contact Lens Prescriptions to Patients Section 315.3 of the Rule provides the framework under which prescribers are required to release contact lens prescriptions to patients and other authorized third parties. Section 315.3 also imposes limitations on the conditions prescribers may require of patients before releasing their prescription. A. Section 315.3(a)(1)—Automatic Prescription Release Section 315.3(a)(1) of the Rule requires a prescriber to provide a copy of the contact lens prescription to the patient after completing a contact lens fitting, regardless of whether it was requested by the patient. Section 315.3(a)(1) of the Rule tracks the language of the Act verbatim.62 This provision, referred to as automatic prescription release, was intended to empower consumers to comparison shop for contact lenses.63 Automatic prescription release has been in effect for 12 years and is now widely supported by commenters, including both prescribers 64 and third-party 60 Several commenters referenced the article published in the CDC weekly report (Cope, supra note 29) for the proposition that the sale of contact lenses requires stricter oversight because of this article’s finding that, ‘‘[a]pproximately 99% of wearers reported at least one contact lens hygiene risk behavior.’’ The Commission notes two important caveats. First, the authors reached this number by including any wearer that indicated that they had ‘‘ever’’ engaged in a risk behavior. Hence, the 99% figure includes every wearer, who at any time, had engaged in a risk behavior even once. Second, the survey instrument asked users where they purchased their lenses, and in a separate article, the authors did not conclude that there was any difference in either habits or health risks based on whether the lenses were purchased from a provider, retail store without an exam, or over the internet. See Robin Chalmers et al., ‘‘Is Purchasing Lenses from the Prescriber Associated with Better Habits Among Soft Contact Lens Wearers?,’’ Cont. Lens Anterior Eye 2016 Aug 12 (Epub ahead of print) PMID: 27527924. 61 See, e.g., 2004 Possible Barriers to E-Commerce Report, supra note 19, at 8–12. 62 15 U.S.C. 7601(a)(1). 63 Contact Lens Rule, Notice of Proposed Rulemaking, 69 FR 5440 (Feb. 4, 2004). 64 See, e.g., American Academy of Ophthalmology (Comment #611) (‘‘we believe [the Rule] empowers consumers to comparison shop for contact lenses’’); Coalition for Patient Vision Care PO 00000 Frm 00006 Fmt 4701 Sfmt 4702 sellers,65 with several recognizing it as the ‘‘cornerstone,’’ 66 or ‘‘pillar,’’ 67 of the Act and the Rule. Of the 660 comments received by the Commission, none explicitly opposed the automatic release provision of the Rule although some prescribers asserted that from a safety perspective, it is in patients’ best interests to purchase contact lenses from their prescribers rather than from thirdparty sellers.68 More common, however, were comments supporting automatic prescription release, but suggesting that the provision was not sufficiently complied with or enforced.69 Other commenters suggested that the automatic prescription release provision should take into account advances in technology. 1. Compliance With the Automatic Prescription Release Requirement Several commenters stated that prescribers routinely fail to comply with the automatic prescription release requirement: Some do not—or do not always—provide a prescription unless a consumer explicitly requests it; some do not provide complete prescriptions, as required by the Rule; and some do not provide prescriptions at all.70 These comments are, in general, concordant with complaints the Commission has received from numerous consumers apart from this rule review process.71 Some consumer complaints, however, may be based on a misunderstanding of the Rule, as there can be confusion Safety (Comment #621) (‘‘Since enactment, and the FTC’s subsequent implementation, the market for contact lenses has become extremely competitive . . . This competition has led to increased investment in research and development, and a proliferation of innovation that served to benefit the nearly 44 million Americans who use contact lenses every day.’’). See also Carroll (Comment #5); Voight (Comment #551); Alianello (Comment #253). 65 See, e.g., 1–800 CONTACTS (Comment #568); Lens.com (Comment #614). 66 Warby Parker (Comment #593). 67 Rhode Island State Representative Kennedy (Comment #536); 1–800 CONTACTS (Comment #568); see also Utah State Senator Bramble (Comment #576); National Association of Optometrists and Opticians (Comment #549); Utah Retail Merchants Association (Comment #28). 68 See, e.g., Woo (Comment #56). 69 See, e.g., 1–800 CONTACTS (Comment #568); Lens.com (Comment #614); Utah State Senator Bramble (Comment #576). 70 See, e.g., Consumers Union (Comment #677); Rhode Island State Representative Kennedy (Comment #536); Lens.com (Comment #614). 71 They are also consistent with longstanding practices of eye care professionals prior to enactment of the Fairness to Contact Lens Consumers Act, even in states where prescribers were required, by state statute, to release prescriptions to consumers. 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) (Testimony of Ami Gadhia, Consumers Union). E:\FR\FM\07DEP2.SGM 07DEP2 asabaliauskas on DSK3SPTVN1PROD with PROPOSALS Federal Register / Vol. 81, No. 235 / Wednesday, December 7, 2016 / Proposed Rules about when or under what conditions patients should receive their prescriptions. For example, the Rule requires that a prescription be provided after the completion of the contact lens fitting, not necessarily at the conclusion of the initial visit with the prescriber. Because a fitting may not be complete until a follow-up visit, a patient might incorrectly believe that she should have been provided with her prescription at the conclusion of the first visit. A number of prescribers commented, to the contrary, that they always provide contact lens prescriptions to their patients, and believe that others in their profession do so as well.72 Prescribers, for their part, may be aware in a general way of their obligation to release prescriptions and yet be unaware of all of the conditions of prescription release required by the Rule. Hence, they might be mistaken in assessing, and reporting on, their own compliance. Many reports of compliance and noncompliance are anecdotal, and robust empirical data are sparse. Although the Commission would prefer better empirical evidence about compliance and noncompliance with the Rule, and about the effects of the Rule, some survey evidence has been submitted by sellers, prescribers, and manufacturers. The Commission considers these submissions to be suggestive and, to an extent, informative, but none can be regarded as definitive. It is important to note, at the outset, that all of these surveys are subject to particular methodological limitations, as well as limits commonly associated with survey evidence. For example, patients may sometimes misremember the details of any particular prior encounter with a prescriber; prescribers, for their part, may be mistaken about the particulars of a given clinical encounter, about the frequency with which they do or do not release prescriptions, or about the frequency or severity of problems they may encounter in verifying prescriptions. For the most part, the surveys do not include independent, objective tests of patient or prescriber recollections. In addition, survey responses may be sensitive to the ways in which survey questions are framed. As part of its comment, 1–800 CONTACTS, the country’s largest online seller of contact lenses, submitted a survey conducted on its behalf by a third-party research firm, Survey Sampling International. That survey found that only 35% of contact lens wearers reported receiving a copy of 72 Howe (Comment #53). See also, e.g., Galdamez (Comment #167); Ahn (Comment #215). VerDate Sep<11>2014 20:36 Dec 06, 2016 Jkt 241001 their prescription without having to ask for it.73 Another 28% reported receiving their prescription upon request (either at the office or afterwards), while 36% said they never received it at all.74 Additional, and similarly-designed surveys, conducted on behalf of 1–800 CONTACTS in November 2014 and May 2015 found that 45% and 48% of contact lens wearers, respectively, reported that they were automatically given a hard copy of their prescription at their last eye exam.75 Some commenters also cited a 2008 report in a contact lens industry publication which found that just half of surveyed optometrists replied, ‘‘yes, to every patient,’’ when asked if they routinely release contact lens prescriptions.76 Other commenters stated that even when consumers receive a copy of their prescription, the prescription information is not always complete or correct. One online seller of replacement lenses contended that some prescribers deliberately render prescriptions incomplete by omitting information, in order to make it more 73 1–800 CONTACTS (Comment #568), Exhibit B. According to 1–800 CONTACTS, the data derives from an online survey of 500 contact lens wearers ages 18–49 years old by Survey Sampling International between Oct. 1 and Oct. 6, 2015. The respondents were not informed of the identity of the survey sponsor. The Commission has concerns about the methodology utilized for this survey, particularly about the lack of an ‘‘I don’t know’’ option for various questions, but believes the information may still be suggestive, particularly when viewed in conjunction with information from other sources and the absence of contradictory data. 74 Id. at 3. 75 1–800 CONTACTS (Comment #568), Exhibit C. According to 1–800 CONTACTS, these data are based on two surveys of 2000 contact lens wearers, randomly selected and conducted in November 2014 and May 2015. These surveys were sponsored by 1–800 CONTACTS and conducted by an independent market research company. As with the 2015 survey cited above, the Commission has concerns about the methodology utilized for these surveys but believes the information may still be suggestive, particularly when viewed in conjunction with information from other sources and the absence of contradictory data. 76 1–800 CONTACTS (Comment #568), Information Technology & Innovation Foundation (Comment #40), Utah Retail Merchants Association (Comment #28) citing Mack, supra note 34. Analogously, an October 2015 SurveyMonkey survey of 1,329 respondents, sponsored by online eyewear seller Warby Parker, reported that 47% of consumers who saw optometrists were not automatically provided with an eyeglass prescription at the end of the exam. Warby Parker (Comment #813 on the Ophthalmic Practice Rules), https://www.ftc.gov/policy/public-comments/ initiative-624. The patients surveyed by SurveyMonkey were primarily consumers who purchased eyeglasses, not contact lenses, but the prescription-release requirement for eyeglass prescriptions is similar to that for contact lenses and both eyeglasses and contact lenses are prescribed by the same categories of eye care professionals. See Ophthalmic Practice Rules, 16 CFR 456.2. PO 00000 Frm 00007 Fmt 4701 Sfmt 4702 88531 difficult for consumers to buy lenses from third-party sellers.77 According to an internal review of prescriptions on file with 1–800 CONTACTS, 23% were missing one or more parameters required to fill an order, and 43% lacked complete contact information for the prescriber.78 Such omissions, when they occur, may be intentional, may reflect clerical or communication errors, or may reflect an imperfect understanding of the Rule’s complete requirements for prescription release. All such errors could reflect failures to comply fully with the requirements of the Rule. The sheer number of verifications conducted by third-party sellers also may suggest that many consumers are not automatically receiving their prescriptions from prescribers, or are not receiving complete prescriptions. Under Section 315.5, verifications are only necessary if a consumer fails to provide a third-party seller with a complete prescription. According to discussions with industry, roughly three-quarters of third-party contact lens sales require prescription verification, meaning that the consumer did not present a complete prescription at the time of the attempted purchase. Seemingly contrary to this data is a survey, conducted on behalf of Johnson & Johnson Vision Care, Inc., a large contact lens manufacturer, according to which 61% of consumer respondents said that they provided the retailer with their prescription the last time they purchased lenses online or by telephone.79 The Commission does not have enough data or insight to determine if either of these surveys accurately reflects industry practice. It is possible that some of these consumers received incomplete or otherwise problematic prescriptions. If so, those consumers might accurately report that they provided something that they believed to be a prescription at the time of purchase when, in fact, the document they provided was not complete or fillable, and hence (a) required verification and (b) was not a ‘‘prescription’’ as defined by the Rule. Alternatively, some consumers could have received their prescriptions from 77 LD Vision Group (Comment #544). CONTACTS (Comment #568) (based on a ‘‘sample of 803 prescriptions on file with 1–800 CONTACTS.’’). The Commission was not provided with the data for this sample, and so cannot judge whether the data are generalizable. Apart from this internal survey, the Commission has not received other empirical evidence demonstrating that prescribers—deliberately or otherwise—failed to provide patients with complete prescriptions. 79 Johnson & Johnson Vision Care, Inc. (Comment #582) (August 2015 telephone survey by APCO Insight for J&J). 78 1–800 E:\FR\FM\07DEP2.SGM 07DEP2 88532 Federal Register / Vol. 81, No. 235 / Wednesday, December 7, 2016 / Proposed Rules asabaliauskas on DSK3SPTVN1PROD with PROPOSALS prescribers but misplaced them, forgot them, or simply thought it easier to obtain the refraction information from their contact lens boxes. Whatever the frequency with which each of these possibilities occurs, it is evident that third-party sellers are presently verifying a significant percentage of contact lens prescriptions with prescribers. It is also evident, based on the comments submitted, that many prescribers feel there are too many verification requests, and that it would be helpful if more patients provided a copy of their prescription to sellers rather than rely on the verification process.80 Another concern raised by commenters is whether consumers are even fully aware of their right to their prescriptions.81 According to the aforementioned October 2015 survey conducted on behalf of 1–800 CONTACTS, 46% of contact lens wearers were unaware that they had a right to receive a copy of their prescription, even though the Rule has been in effect since 2004.82 The manner in which this particular question was phrased in the 1–800 survey,83 however, raises Commission concerns about the validity of, or the weight that should be accorded to, the results for this question. In particular, the question is leading, it lacks an ‘‘I don’t know’’ option, it uses a term—‘‘hard copy’’— which some patients may not understand, and it is phrased in such a way that it could give rise to social desirability bias,84 since respondents might be reluctant to admit that they are unaware of their rights under federal law. That being said, a response error resulting from social desirability bias in this instance would more likely lead to undercounting, or underestimation, of the number of patients who are unaware they have a right to their prescription. In other words, the way the question 80 See, e.g., Carroll (Comment #5) (‘‘[Verification] is costly to my business. the patient should have a written copy of their Rx to provide to the vendor of their choice.’’); Walton (Comment #543) (‘‘It should be the consumer’s responsibility to provide the seller a full, unexpired contact lens prescription and the doctor prescribing should not have to be involved in this process. It puts undue stress on small local businesses to have to respond to faxes’’); Baur (Comment #170) (‘‘If I am already handing patients a copy of their prescription, why do I have to verify the Rx at all?’’). 81 Warby Parker (Comment #593); 1–800 CONTACTS (Comment #568). 82 1–800 CONTACTS (Comment #568), Exhibit B. 83 The question was phrased as follows: ‘‘Are you aware that it is your right under federal law, as a patient to receive a hard copy of your contact lens prescription from your eye exam provider?,’’ with the only possible answers being Yes or No. 84 Social desirability bias is the tendency of survey respondents to answer questions in a manner that will be viewed favorably by others. VerDate Sep<11>2014 20:36 Dec 06, 2016 Jkt 241001 was phrased could make it seem that more patients are aware of their right than is actually the case, and it is thus possible that more than 46% of contact lens wearers are unaware that they have a right to automatically receive their prescription at the end of their contact lens fitting. 2. Commenter Suggestions for Improving Automatic Prescription Release Compliance Some commenters asked the Commission to take specific actions to increase compliance with the automatic prescription release requirement.85 Some commenters recommended that the Commission increase the number of enforcement actions it takes against prescribers who fail to comply with automatic prescription release in order to ‘‘send a message to complacent prescribers.’’ 86 Another suggestion, put forth by 1–800 CONTACTS and other third-party sellers, is to amend the Rule to require that, immediately upon completing a contact lens fitting, prescribers provide patients with an eye care patients’ ‘‘Bill of Rights,’’ informing them of their right to their prescription, that the prescription will be provided without request, and that they have a right to purchase lenses from the seller of their choice.87 Another commenter, Consumers Union, the policy and advocacy division of Consumer Reports, suggested that prescribers inform consumers at the beginning of their visit—as part of the initial paperwork— that they will provide a prescription at the end of the examination at no additional cost.88 Other commenters suggested requiring patients to sign an ‘‘Acknowledgment of Release’’ document, confirming that they received their prescriptions.89 Prescribers would be required to retain the signed acknowledgments, which then could be inspected by the Commission to verify compliance.90 One commenter, an Arizona state representative, said she was considering introducing state legislation that would 85 See, e.g., 1–800 CONTACTS (Comment #568); Utah Retail Merchants Association (Comment #28); Utah State Senator Bramble (Comment #576); Information Technology & Information Foundation (Comment #40); Lens.com (Comment #614); Warby Parker (Comment #593). 86 1–800 CONTACTS (Comment #568). See also Utah State Senator Bramble (Comment #576); Utah Retail Merchants Association (Comment #28). 87 1–800 CONTACTS (Comment #568). See also Warby Parker (Comment #593); Lens.com (Comment #614). 88 Consumers Union (Comment #677). 89 Lens.com (Comment #614); 1–800 CONTACTS (Comment #568). See also Arizona State Representative Carter (Comment #545). 90 Id. PO 00000 Frm 00008 Fmt 4701 Sfmt 4702 mandate such signed acknowledgments for prescribers in her state.91 3. Analysis of Proposals for Improving Automatic Prescription Release Compliance and Commission Proposal Having considered the various comments and suggestions, the Commission believes that improving compliance with automatic prescription release would further the goals of the Act. While none of the five surveys 92 cited by commenters are definitive on the question of automatic release compliance, the Commission believes that the overall weight of evidence in the rulemaking record—including the surveys, the high number of verifications, the ongoing pattern of consumer complaints and anecdotal reports, and the industry’s long history of failing to provide prescriptions to patients even when obligated by state law—indicates that compliance with the automatic prescription release provision could be substantially improved. Furthermore, the potential benefits of increasing the number of patients who receive their prescriptions are substantial: Increased patient flexibility and choice in shopping for contact lenses; a reduced number of verification requests, which some prescribers find burdensome; a reduced likelihood of errors associated with incomplete prescriptions; and a reduction in the number and complications of failed attempts at verification. Increasing compliance also is likely to spur more competition and innovation among contact lens sellers and manufacturers. It should also reduce the number of attempts by sellers to verify expired or inaccurate prescriptions, as well as attempts to verify prescriptions with the wrong prescriber, practices that many prescribers complained about in their comments.93 The cumulative effect of increased compliance would likely be lower costs and improved convenience and flexibility for patients, sellers, and prescribers as well as increased accuracy of prescriptions presented to sellers, thereby reducing potential consumer harm from inaccurate, expired, or otherwise invalid prescriptions.94 Having determined that it would be beneficial to increase compliance with 91 Arizona State Representative Carter (Comment #545). 92 See supra notes 73–76, citing surveys by Survey Sampling International, Contact Lens Spectrum, and SurveyMonkey. 93 See infra Section IV. 94 See, e.g., Lens.com (Comment #614) (predicting that improving automatic prescription release compliance could lead to lower contact lens prices, since it would reduce verification costs for both sellers and prescribers). E:\FR\FM\07DEP2.SGM 07DEP2 Federal Register / Vol. 81, No. 235 / Wednesday, December 7, 2016 / Proposed Rules asabaliauskas on DSK3SPTVN1PROD with PROPOSALS the automatic prescription release provision, the Commission now evaluates various proposals put forth by commenters for how to best achieve this goal. (a) Proposal To Increase Enforcement Several commenters suggested that one way to better ensure automatic prescription release compliance is for the Commission to become more aggressive about enforcement.95 According to 1–800 CONTACTS, ‘‘Prescribers today clearly believe they can disregard their legal obligations without consequence.’’ 96 1–800 CONTACTS urged the Commission to regularly investigate prescriber practices and issue warning letters or take enforcement actions against prescribers that do not comply with the automatic prescription release provision.97 According to 1–800 CONTACTS, this would not only change the behavior of the targeted prescribers, but would send a signal to other prescribers that they need to comply with the Rule. The Commission recognizes the need for increased enforcement of the automatic prescription release provision and already has taken some recent steps to achieve better compliance. For example, in April 2016, the Commission sent warning letters to 45 contact lens prescribers after receiving consumer complaints alleging that the prescribers had violated the Rule, often by failing to provide patients with their prescriptions automatically.98 The Commission acknowledges, however, that the absence of documentation makes it difficult to determine whether a prescriber did or did not provide a patient with a prescription as required, in any particular case. The absence of documentation also makes it difficult to determine how many times, or how frequently, a noncompliant party has violated the Rule. Instead, allegations and denials of Rule violations might often become a matter of the patient’s word against that of the prescriber, making accurate enforcement decisions, as well as enforcement actions predicated on those decisions (as opposed to warning letters) more challenging. The Commission thus believes that enforcement could improve through a mechanism to 95 1–800 CONTACTS (Comment #568). See also Utah State Senator Bramble (Comment #576); Utah Retail Merchants Association (Comment #28). 96 1–800 CONTACTS (Comment #568). 97 Id. at 25–26. 98 Press Release, Fed.Tr. Comm’n, FTC Issues Warning Letters Regarding the Agency’s Contact Lens Rule (Apr. 7, 2016), https://www.ftc.gov/newsevents/press-releases/2016/04/ftc-issues-warningletters-regarding-agencys-contact-lens-rule. VerDate Sep<11>2014 20:36 Dec 06, 2016 Jkt 241001 increase its ability to assess and verify compliance with the Rule’s automatic prescription release requirements. (b) Proposal To Require an Eye Care Patients’ Bill of Rights or Notice-UponCheck-In A number of commenters recommended that the Commission amend the Rule to require that prescribers provide patients with written notices informing them of their right to their prescription. One suggestion, proposed by three online sellers of eye wear, is that, immediately upon completion of a contact lens fitting, prescribers provide patients with a ‘‘Bill of Rights’’; that is, a written notice informing patients of their rights under the Rule, including: (1) The right to receive their prescriptions; (a) provided promptly and automatically without their having to request them; (b) at no additional charge; and (2) the right to purchase their lenses from the seller of their choice.99 Another suggestion, put forth by a consumers’ rights organization, is that the Rule require that, ‘‘the eye doctor inform the consumer at the beginning of the visit, as part of the initial paperwork, that the prescription will be provided at the conclusion of the visit at no additional cost.’’ 100 Either of these proposals, if implemented and complied with, would notify consumers of their rights and, presumably, would increase the percentage of patients who receive prescriptions from their prescribers. Providing the required document would remind prescribers and their staffs to provide patients with their prescriptions, and it would remind patients to ask for their prescriptions in the event that the prescriber might fail to provide them initially and without a request, as the Rule and the Act already require. Since the Commission could draft the specific language for either the ‘‘Bill of Rights’’ or check-in notice, it could ensure that the notice conveys an accurate explanation of the Rule’s automatic prescription release requirements, something prescribers sometimes fail to do.101 The 99 1–800 CONTACTS (Comment #568). See also Warby Parker (Comment #593); Lens.com (Comment #614). 100 Consumers Union (Comment #677). 101 Imprecise word selection by prescribers may, in some cases, lead prescribers to inadvertently violate the rule. For example, an eye care practitioner may believe he is complying by asking patients, ‘‘Do you want a copy of your prescription?’’ when, in fact, such a question is a violation of the automatic release provision since the prescription is not provided automatically but rather requires patients to confirm that they want PO 00000 Frm 00009 Fmt 4701 Sfmt 4702 88533 requirement should also impose a relatively small burden upon prescribers, since prescribers would only need to provide a brief, standard form for each patient. On the other hand, patients already receive forms and other paperwork when they visit a prescriber, increasing the possibility that patients might not read or attend to the information in the ‘‘Bill of Rights’’ or check-in notice. Moreover, the Rule already requires that prescribers provide patients with copies of their prescriptions, yet diverse complaints have alleged that many prescribers do not do so. It is at least possible that many prescribers who now fail to comply with the Rule’s prescription release requirements would also fail to comply with a requirement to provide a patients’ ‘‘Bill of Rights’’ or check-in notice form. Without some mechanism to ensure compliance, a notice by itself might not provide substantial benefits. The notices recommended by these proposals would not require the type of prescriber recordkeeping needed to assist the Commission in better Rule enforcement, either in its current form or as it might be amended. It is thus possible that adding this requirement would impose an increased burden on prescribers without providing many tangible, countervailing benefits to consumers. In light of these considerations, the Commission has determined not to propose to amend the Rule to require either a Bill of Rights or notice-uponcheck-in. (c) Proposal To Require a Signed Acknowledgment Form Another amendment recommended by some commenters is to require that prescribers present, and patients sign, an ‘‘acknowledgment of release,’’ confirming that they received their prescription at the end of their contact lens fitting.102 Such an acknowledgment would be a separate, stand-alone document, and prescribers would be required to retain the signed acknowledgments.103 An acknowledgment of release would notify consumers of their prescription portability rights and, in all likelihood, increase the percentage of patients who receive their prescription from the prescriber. Providing the required form would also serve as a reminder to it. This, in turn, may put patients in an awkward position since they may feel they are going behind the prescriber’s back by shopping for contacts elsewhere. 102 Lens.com (Comment #614); 1–800 CONTACTS (Comment #568). See also Arizona State Representative Carter (Comment #545). 103 Id. E:\FR\FM\07DEP2.SGM 07DEP2 asabaliauskas on DSK3SPTVN1PROD with PROPOSALS 88534 Federal Register / Vol. 81, No. 235 / Wednesday, December 7, 2016 / Proposed Rules prescribers and their staffs to provide patients with their prescriptions, and serve as a reminder to patients to ask for their prescription in the event that they receive the acknowledgment form but not the prescription. Once it becomes an established practice, an acknowledgment form might also reduce confusion for patients as to when their contact lens fitting is actually complete, thus reducing the likelihood of erroneous complaints about a prescriber’s perceived failure to provide a prescription after the completion of a preliminary examination but when the contact lens fitting has not yet been completed. Additionally, since patients would have to affirmatively sign such an acknowledgment, it is less likely that such a document would go unnoticed or unread by patients than a ‘‘Bill of Rights’’ or notice-upon-check-in type of document. And perhaps most importantly, requiring prescribers to retain a signed acknowledgment form would improve the Commission’s ability to verify whether prescribers had complied with this requirement and had met their obligation to release prescriptions to their patients. Being able to determine more accurately whether a particular prescriber had provided a prescription in a particular case would reduce the number of instances where a filed complaint simply pits the patient’s word against that of the prescriber. It would also enable the Commission to evaluate the overall rate at which both individual prescribers and the population of prescribers comply with the requirement. One potential drawback to requiring a signed acknowledgment requirement is the increased recordkeeping burden imposed on prescribers, since they would have to provide the forms and retain the signed acknowledgments for a certain period of time.104 This recordkeeping burden could be reduced to the extent that prescribers have adopted electronic medical record systems, especially those where patient signatures can be recorded electronically and input automatically into the electronic record. Furthermore, prescribers also could scan signed paper copies of the acknowledgment form and store those forms electronically to lower the costs of this recordkeeping requirement. Accordingly, the Commission believes that any recordkeeping burden would be 104 1–800 CONTACTS suggested that prescribers should maintain records of acknowledgments for three years or the length of the prescription, whichever is longer. 1–800 CONTACTS (Comment #568). VerDate Sep<11>2014 20:36 Dec 06, 2016 Jkt 241001 relatively minimal and outweighed by the benefit of having more patients in possession of their prescriptions. (d) Proposal To Require Signage Another possible Rule revision is to require that prescribers’ offices post conspicuous signage informing consumers of their right to their prescription. Although this was not specifically suggested by commenters,105 it is currently required by law in California, and the practice could be expanded via the Rule to apply nationwide. In California, the Business and Professional Code provides that each prescriber office must post, in a conspicuous place, a notice informing patients that eye doctors are required to provide patients with a copy of their ophthalmic lens prescriptions. The notice also explains that spectacle prescriptions are released upon the completion of the exam, and contact lens prescriptions are released upon the completion of the exam or upon the completion of the fitting process.106 Such a requirement, if adopted in the Rule, could provide some of the same benefits of the Bill of Rights, noticeupon-check-in, and signed acknowledgment proposals in that it would, in theory, notify consumers of their rights and, presumably, increase the percentage of patients who receive their prescription from the prescriber. A sign could also serve as a reminder to patients to ask for their prescription in the event the prescriber does not provide it. Furthermore, a sign would impose less of a burden on prescribers than the other proposals, since it would only have to be posted once, as opposed to individual copies for each and every patient. Lastly, enforcing such a provision would be relatively straightforward, since the Commission could perform spot checks on prescribers’ offices to ensure they have posted the required signage. On the other hand, the Commission lacks good evidence about the effects of California’s particular version of this requirement, and it is unclear how many patients actually read posted notices at doctors’ offices, particularly in locations where there are already numerous ads or other postings about 105 It was cited in the National Association of Optometrists and Opticians comment, but not expressly recommended. Comment #549. 106 16 CCR § 1566. California also has an additional state law, CAL Bus. & Prof. Code § 2554, which essentially requires the same signage, with the addition of a notice stating, ‘‘Patients may take their prescription to any eye doctor or registered dispensing optician to be filled,’’ and requiring the inclusion of complaint contact information for the California Board of Optometry. PO 00000 Frm 00010 Fmt 4701 Sfmt 4702 various rights, requirements, and obligations. It is likely that far fewer patients would learn of their rights from a single sign—competing for attention with ads and other signage—than from being handed or shown a document, particularly a document consumers are required to sign. Moreover, since a sign would not require a prescriber to interact with each patient, it would serve as less of a reminder to prescribers and their staff to provide patients with their prescriptions. And, although it would be relatively straightforward for the Commission to verify and enforce the signage requirement, such a requirement would do little to assist the Commission in verifying or enforcing compliance with the automatic prescription release provision itself. Furthermore, Commission staff would have to physically visit prescribers’ offices located throughout the country to verify the signage, resulting in the expenditure of more Commission resources to monitor compliance. (e) The Commission’s Proposal To Require a Signed Acknowledgment After consideration of the comments and proposals, the Commission proposes to add a signed acknowledgment requirement. The Commission believes such a provision will help inform patients of their right to their prescriptions, increase the number of patients who receive their prescriptions and, consequently, increase the number of purchases made with initial presentations of complete and valid prescriptions, thus reducing the number of verifications by thirdparty sellers. The addition of a signed acknowledgment requirement accomplishes the desired objectives with little increased burden on prescribers. The Commission believes that implementation of signed acknowledgments would best serve several important objectives: Reminding prescribers to release prescriptions, informing patients of their rights, reducing misunderstandings, and improving the Commission’s verification and enforcement ability. The requirement that the prescriber request the patient acknowledge receipt of the contact lens prescription is triggered once the prescriber has presented the prescription to the patient. The patient shall receive the prescription prior to being asked to sign the acknowledgment form, and signing the acknowledgment form is not a condition to obtain the prescription. If the patient refuses to sign or cannot sign the acknowledgment form, the prescriber must note the refusal or E:\FR\FM\07DEP2.SGM 07DEP2 asabaliauskas on DSK3SPTVN1PROD with PROPOSALS Federal Register / Vol. 81, No. 235 / Wednesday, December 7, 2016 / Proposed Rules inability on the acknowledgment form and must maintain the form. The acknowledgment form may be either paper or in electronic format. The acknowledgment form, whether paper or electronic, must be entitled ‘‘Patient Receipt of Contact Lens Prescription,’’ and must 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.’’ The acknowledgment form shall be in a format that allows either conventional or electronic signatures. Prescribers may maintain copies of the acknowledgment forms in paper or electronically. The Commission, therefore, proposes to amend Section 315.3 to add the requirement that upon completion of a contact lens fitting, and after providing a copy of the contact lens prescription to the patient, the prescriber shall request that the contact lens patient acknowledge receipt of the contact lens prescription by signing an acknowledgment form entitled, ‘‘Patient Receipt of Contact Lens Prescription.’’ This form must state, ‘‘My eye care professional provided me with a copy of my contact lens prescription at the completion of my contact lens fitting. I understand I am free to purchase contact lenses from the seller of my choice.’’ In addition, the form must also include the name of the patient, the patient signature, and the date the form was signed. In the event that the patient declines to sign the acknowledgment form, the prescriber shall note the patient’s refusal on the form and sign it. No other statements or information, other than the address or letterhead of the prescriber, shall be placed on the acknowledgment form. The Commission also proposes to amend Section 315.3 to add the requirement that prescribers maintain the signed acknowledgments for a period of not less than three years, so that the signed acknowledgments are available for inspection by the Federal Trade Commission. The full text of the proposed Rule amendment is located in Section X of this notice. 4. Additional Mechanisms for Improving Prescription Portability The increasing number of prescribers who offer patient ‘‘portals’’ accessible via the Internet has made it possible for prescribers to post, and patients to obtain, prescriptions online, while maintaining the security and privacy of VerDate Sep<11>2014 20:36 Dec 06, 2016 Jkt 241001 patients’ health information.107 This, along with the patient’s ability to email prescription copies to sellers, increases prescription portability. It also could reduce the verification burden on prescribers, to the extent that patients could quickly and reliably obtain complete and accurate copies of their prescriptions,108 without making specific requests to their prescribers for such copies, and to the extent that such prescriptions could be filled without the seller intervening to verify the prescriptions directly with the prescribers. In addition, patient portals do not raise the same concerns expressed by some prescribers about sharing patient prescription information with third parties, because patient portals enable the secure sharing of such information directly with the patients themselves.109 Accordingly, the Commission believes that the use of patient portals to provide patients with access to electronic copies of their prescriptions can benefit prescribers, sellers, and patients. The Commission encourages prescribers, in 107 Although the Commission lacks data on the use of patient portals by ophthalmologists or optometrists in particular, the Commission notes that a recent report to Congress observes that increasing numbers of physicians and other types of health care providers are sharing information electronically with their patients. For example, in 2014, four in 10 office-based physicians reported sharing information electronically with their patients, and 57% of all physicians reported sharing information directly with their patients electronically. U.S. Dep’t Health & Human Servs., Office of the National Coordinator for Health Information Technology, Report to Congress, ‘‘Update on the Adoption of Health Information Technology and Related Efforts to Facilitate the Electronic Use and Exchange of Health Information’’ 28–30 (2016), https:// www.healthit.gov/sites/default/files/Attachment_1_ -_2-26-16_RTC_Health_IT_Progress.pdf. 108 Empirical studies of the integrity of electronic transmission of prescription information chiefly focus on systems for transmitting prescription drug information and not contact lens prescriptions. Still, such studies suggest that the adoption of electronic prescribing greatly reduces the error rate associated with handwritten paper prescriptions. See, e.g., Rainu Kaushal et al., ‘‘Electronic Prescribing Improves Medication Safety in Community-Based Office Practices,’’ 25 J. Gen. Intern. Med. 530, 530 (2010) (finding that, ‘‘For eprescribing adopters, error rates decreased nearly sevenfold, from 42.5 per 100 prescriptions (95% confidence interval (‘‘CI’’), 36.7–49.3) at baseline to 6.6 per 100 prescriptions (95% CI, 5.1–8.3) one year after adoption (p<0.001). For non-adopters, error rates remained high at 37.3 per 100 prescriptions.’’). 109 See, e.g., U.S. Dep’t Health & Human Servs., HealthIT.gov, ‘‘Do I Need to Obtain Consent From My Patients to Implement a Patient Portal?,’’ https://www.healthit.gov/providers-professionals/ faqs/do-i-need-obtain-consent-my-patientsimplement-patient-portal (noting that HIPAA permits the disclosure of health information to the patient without requiring the patient’s express consent and that portals are ‘‘an excellent way to afford patients access to their own information and to encourage them to be active partners in their health care.’’) PO 00000 Frm 00011 Fmt 4701 Sfmt 4702 88535 addition to providing patients with a copy of their prescriptions, to make prescriptions available via patient portals in accordance with federal and state law, including HHS guidance. Uploading prescriptions to patient portals will make it easier for patients to access their prescriptions and, consequently, to transmit them to sellers when purchasing lenses. This, in turn, may substantially increase the accuracy of seller-filled orders and reduce the verification burden on prescribers.110 To facilitate the likelihood that patient portals will increase prescription portability, the patient portal should be configured to allow the patient to download, save, and print the prescription, as well as to allow the patient to email, or otherwise transmit, prescriptions directly to a seller. At this time, the Commission does not have enough information to determine whether solely posting a contact lens prescription to a patient portal is sufficient to satisfy the Rule’s obligation for prescribers to provide copies of contact lens prescriptions to patients. However, the Commission seeks comment on the use and adoption of patient portals, as well as the potential ability for such technology to allow prescribers to comply with the automatic prescription release requirement of the Rule. B. Section 315.3(a)(1)—Additional Copies of Prescriptions Some commenters requested that the Commission amend the Rule to expressly obligate prescribers to provide duplicate prescription copies to patients upon request.111 According to Consumers Union, such a requirement would provide ‘‘additional protection for situations in which the eye doctor neglects to provide the prescription during the visit, as well as for situations in which the prescription is misplaced by the consumer.’’ 112 Likewise, the health and safety organization Prevent Blindness asserted that duplicate copies should be available upon request since ‘‘[i]t is a basic consumer right to own one’s prescriptions.’’ 113 During the initial rulemaking, the Commission stated that the Act neither requires prescribers to release, nor prohibits them from releasing, additional copies of the prescription.114 At that time, the Commission declined 110 See Kaushal, supra note 108. Blindness (Comment #13); Consumers Union (Comment #677). 112 Consumers Union (Comment #677). 113 Prevent Blindness (Comment #13). 114 69 FR at 40492. 111 Prevent E:\FR\FM\07DEP2.SGM 07DEP2 88536 Federal Register / Vol. 81, No. 235 / Wednesday, December 7, 2016 / Proposed Rules to require or prohibit the release of additional copies of the prescription.115 Upon consideration of the comments, the rulemaking record, and a reexamination of the language of the Act itself, the Commission now clarifies that the Act and the Rule require that prescribers provide patients with additional copies of their prescriptions upon request. Accordingly, the Commission believes there is no need to amend the Rule, but seeks comment on this clarification. This determination is supported by a number of considerations. First, as noted above, during the initial rulemaking, the Commission stated that the Act neither requires nor prohibits additional copies of the prescription. However, this statement was made in response to two commenters who recommended that the prescription release obligation be limited to one release per patient. Thus, the Commission did not fully consider whether additional copies should be required, only that the Act did not expressly limit patients to one copy. Second, the Act and the Rule require that prescribers provide or verify the patient’s prescription when so ‘‘directed by any person designated to act on behalf of the patient.’’ 116 This provision has been interpreted to mean that prescribers must provide a prescription whenever a patient authorizes an agent to request one, even if the patient previously received a prescription copy from the prescriber.117 The Commission’s Division of Advertising Practices, which administers and enforces the Rule, arrived at this interpretation based upon the plain language of the Act and Rule, as well as upon recognition that when consumers want to order contact lenses, ‘‘some consumers have neither their prescription nor sufficient information about their prescription for [the seller] to prepare a proper verification request.’’ 118 Based upon this 115 Id. 116 15 U.S.C. 7601(a)(2); 16 CFR 315.3(a)(2). Staff Opinion Letter to the American Optometric Association Providing Guidance Regarding How Contact Lens Prescribers Should Respond to Requests for Patients’ Contact Lens Prescriptions, Pursuant to the Fairness to Contact Lens Consumers Act and the Contact Lens Rule, Oct. 4, 2006 (stating that if the seller is an agent of the consumer, ‘‘the prescriber has an obligation under the FCLCA and the Contact Lens Rule to provide the consumer’s prescription’’ to the seller) https://www.ftc.gov/public-statements/2006/10/ requests-contact-lens-prescribers-provide-patientscontact-lens; 1–800 CONTACTS (Comment #568), Exhibit E (same). 118 Id. The American Optometric Association takes exception to this interpretation, and argues that if Congress meant for retailers to be able to demand patients’ prescription at any time, then asabaliauskas on DSK3SPTVN1PROD with PROPOSALS 117 See VerDate Sep<11>2014 20:36 Dec 06, 2016 Jkt 241001 interpretation, duly authorized patients’ agents (sellers) are able to obtain a duplicate copy of the patients’ prescription upon request. In addition, patients, acting as their own agents, are able to obtain a duplicate copy of their prescription upon request.119 Furthermore, as discussed earlier, because the Commission believes that many prescribers are not providing patients with their prescriptions upon completion of their contact lens fitting,120 there is additional justification for ensuring that patients are able to obtain copies of their prescription when necessary. The Commission therefore believes that requiring prescribers to provide additional copies of contact lens prescriptions to patients upon request is consistent with the language and intent of the Act: Providing prescription portability while protecting consumer health. Consumers with ongoing access to their prescriptions will be able to obtain the correct contact lenses from the seller of their choosing. C. Section 315.3(a)(2)—Provide or Verify the Contact Lens Prescription Section 315.3(a)(2) of the Rule requires that prescribers shall, as directed by any person designated to act on behalf of the patient, provide or verify the contact lens prescription by electronic or other means.121 1. Sellers Designated To Act on Behalf of Patients In addition to the obligation to release the prescription to the patient at the completion of a contact lens fitting, the Rule also requires prescribers to provide the contact lens prescription to third parties acting on behalf of the patient.122 Accordingly, some sellers, at the direction of their customers, have requested copies of prescriptions from ‘‘the entire verification process would have been all but unnecessary.’’ Comment #644. The Commission disagrees with this contention, however, because verification is simply an additional option for ensuring that patients have a valid prescription, one that is faster and less paper-intensive, for both the seller and prescriber, than requiring that the prescriber always provide the complete patient prescription. Moreover, the Act and the Rule state that the prescriber must provide or verify the contact lens prescription as directed by the patient’s agent, thus leaving it up to the agent, if so authorized by the patient, to decide which method is preferable. 119 15 U.S.C. 7601(a)(2); 16 CFR 315.3(a)(2). In addition, the HIPAA Privacy Rule right of access requires a covered prescriber to provide a copy of a prescription to the patient upon request or to another person she designates. See 45 CFR 164.524(c)(3). See infra Section V.C. 120 See supra Section III.A.1. 121 16 CFR 315.3(a)(2). 122 Id. PO 00000 Frm 00012 Fmt 4701 Sfmt 4702 prescribers rather than just verifications of prescriptions.123 Because this practice historically has been a source of confusion for some eye care practitioners, the staff clarified, in a 2006 letter to the American Optometric Association, that the Rule obligates a prescriber to provide the consumer’s complete prescription to a third-party seller if the consumer has authorized that seller as an agent.124 In its letter, FTC staff also made clear that the Act and the Rule do not permit the prescriber to require that sellers provide written documentation of the patient’s authorization before providing the seller with a copy of the patient’s prescription.125 In response, the American Optometric Association has provided guidance to its members that they must comply with this provision of the Rule.126 This option may be gaining popularity with at least one seller. As explained by 1–800 CONTACTS, ‘‘[d]ue in large part to poor prescriber compliance with prescription release requirements, many customers cannot provide a third-party seller with [a] copy of their contact lens prescription at the time they place their order.’’ 127 1–800 CONTACTS also pointed out that this option benefits consumers because with a copy of the prescription on file, it can ship orders without any delay and without having to contact the prescriber each time the consumer wishes to purchase lenses.128 In its comment, however, the American Optometric Association argued that ‘‘[r]equests by sellers directly to physicians for copies of patient prescriptions should be disfavored.’’ 129 The American Optometric Association asserted that sellers should use the verification system instead because verification requests consume less time than the retrieval, copying, and transmission of the actual prescription to sellers. The American Optometric Association acknowledged that it believes that the Rule’s verification system needs improvement, but pointed out that it contains safeguards that requests for 123 See, e.g., 1–800 CONTACTS (Comment #568). Opinion Letter, supra note 116. 125 The opinion letter also explains that neither the Health Insurance Portability and Accountability Act (‘‘HIPAA’’) of 1996 nor its implementing regulations require such written documentation of the authorization. 126 American Optometric Association, Summary of Advisory from AOA General Counsel Regarding FCLCA Enforcement Update, Sept. 1, 2015, http:// www.aoa.org/Documents/advocacy/FTC_guidance_ on_Rx_releases.pdf. 127 Comment #568. 128 Id. 129 Comment #644. 124 Staff E:\FR\FM\07DEP2.SGM 07DEP2 Federal Register / Vol. 81, No. 235 / Wednesday, December 7, 2016 / Proposed Rules asabaliauskas on DSK3SPTVN1PROD with PROPOSALS copies of prescriptions do not.130 The American Optometric Association stated that sellers would only need to request a copy of a prescription directly from the prescriber when the patient does not submit the prescription and the patient is unable to provide any information about the prescription to the seller in order to permit use of the verification process.131 Few other prescribers addressed this issue directly in their comments to this Rule review.132 However, the Commission also has received anecdotal reports that prescribers are still confused about this provision of the Rule, and some comments appear to conflate requests for a copy of a prescription with an incomplete verification request. For example, some prescribers complained that 1–800 CONTACTS was sending them incomplete verification requests, but instead it appears that 1–800 CONTACTS was sending the prescriber a request for the patient’s prescription. The Commission declines to adopt the American Optometric Association’s suggestion that requests for copies of a prescription by a duly authorized seller be discouraged. The plain language of the Act and the Rule provide for this method of acquiring a prescription and the Association provided no evidence demonstrating that providing a copy of a prescription to a seller, rather than verifying a prescription, was significantly more burdensome to prescribers. As to the contention that the verification system contains safeguards that requests for prescriptions do not, the Commission points out that a prescription provided by a prescriber directly to the seller would necessarily include all relevant information and would avoid some of the issues raised by commenters about the flaws of the verification system. In addition, the copy of the prescription provided by the prescriber to the seller would contain an expiration date, which also serves as a safeguard against the improper dispensing of contact lenses. Despite clarifications that prescribers must provide copies of prescriptions to 130 Although the American Optometric Association comment did not specifically mention the safeguards, it is likely that the comment is referring to fact that if a prescription verification request lists a quantity of lenses that is excessive, the prescriber can deem such a request ‘‘inaccurate.’’ 131 Comment #644. 132 Diener (Comment #6) (the ‘‘rule should be restricted to use only upon recent patient request, not used in perpetuity to obtain records for marketing purposes’’); Vidulich (Comment #612) (silent on the issue, but attaching request for a copy of the prescription). VerDate Sep<11>2014 20:36 Dec 06, 2016 Jkt 241001 sellers when authorized by the patient, 1–800 CONTACTS complained in its comment that in its experience, about half of prescribers ‘‘routinely ignore [their] requests’’ for a copy of a patient’s prescription.133 To address problems encountered by authorized agents in procuring copies of prescriptions, as well as ongoing prescriber confusion about this provision, two commenters proposed amending Section 315.3 ‘‘to require that in response to an authorized request, the prescriber send the prescription to the agent (by mail, facsimile or a digital image of the prescription that is sent via electronic mail) within eight business hours as currently defined under the [Rule].’’ 134 In support of its proposal, 1–800 CONTACTS stated that, ‘‘[e]vidence shows that in about half the cases, prescribers ignore and never respond to 1–800’s authorized requests for a copy of a customer’s prescription.’’ 135 1–800 CONTACTS does not specify this evidence in its comment. However, in a 2006 letter to the Commission, 1–800 CONTACTS asserted that an audit of 264 requests for a copy of a customer’s prescription shows that 46% of prescribers did not respond within five business days.136 The other commenter, Warby Parker, provided no evidence in support of its proposal.137 The Act and the Rule currently require the prescriber to provide a copy of a prescription to an authorized third party, but is silent on the timing of the response. The proposed modification would require prescribers to provide a prescription within eight business hours, the same amount of time that prescribers are afforded to respond to a verification request. The Commission notes, however, that there is a qualitative difference between responding to a verification request as opposed to providing a copy of a prescription. First, if the verification request is correct, the prescriber need take no action.138 Second, the proposed modification would require the prescriber to act within eight business hours, and if the prescriber did not act, or was unable to act, she would be in violation of the Rule. The eightbusiness-hour window for verification 133 Comment #568. see also Warby Parker (Comment #593). 135 Comment #568. 136 See 1–800 CONTACTS (Comment #568), Exhibit E. 137 Warby Parker (Comment #593). Warby Parker also proposed that the prescriber be required to maintain a log recording the date and time a patient’s prescription was requested and released to the authorized agent. 138 Based on discussions with industry, it appears that the vast majority of verification requests are passively verified, with no prescriber action taken. 134 Id.; PO 00000 Frm 00013 Fmt 4701 Sfmt 4702 88537 does not place the prescriber in such jeopardy. If the prescriber is unable to respond to a verification request in a timely fashion—for whatever reason— the request is verified, but the prescriber is not in violation of the Rule. At this time, the Commission has determined that the existing rulemaking record is not sufficient to support a Rule modification requiring a prescriber to respond to a request for a copy of a prescription within eight business hours. Accordingly, the Commission requests additional information from commenters on the costs and benefits of imposing a timeframe for prescribers to respond to requests from authorized third parties for a copy of a patient’s prescription. The Commission also seeks comment on the appropriate amount of time for a prescriber to respond to prescription requests.139 IV. Prescriber Verification Section 315.5 of the Rule provides the framework under which sellers may dispense contact lenses to consumers and requires sellers, before selling contact lenses, to either obtain a copy of the patient’s prescription or verify the prescription. Section 315.5 also sets forth the procedures for obtaining such verification as well as seller recordkeeping obligations. A. Section 315.5(a)—Prescription Requirement Section 315.5(a) of the Rule provides that a seller may sell contact lenses only in accordance with a contact lens prescription for the patient that is presented to the seller by the patient or prescriber directly or by facsimile; or verified by direct communication. This provision was taken verbatim from the Act.140 1. Presentation of Prescriptions ‘‘Directly or by Facsimile’’ In the initial rulemaking, the Commission determined that the ‘‘directly or by facsimile’’ language of section 4(a)(1) of the Act allowed the 139 Another commenter, Opternative, a telehealth provider, proposed that the Commission ‘‘consider expanding the verification requirements so that prescribers’ obligations also apply to any other third party, including other prescribers, that is authorized by the patient.’’ Comment #648. Section 315.3 explicitly states that the prescriber shall provide or verify the contact lens prescription, ‘‘as directed by any person designated to act on behalf of the patient.’’ Nothing in the Act or Rule precludes the construction of ‘‘any person’’ from including other prescribers. Furthermore, the HIPAA Privacy Rule permits a ‘‘covered entity’’ to use or disclose protected health information without patient authorization ‘‘for treatment, payment, or health care operations.’’ 45 CFR 164.506. The Commission does not believe that the Rule needs any modification on this issue. 140 69 FR at 40495; see also 5 U.S.C. 7603(a). E:\FR\FM\07DEP2.SGM 07DEP2 88538 Federal Register / Vol. 81, No. 235 / Wednesday, December 7, 2016 / Proposed Rules asabaliauskas on DSK3SPTVN1PROD with PROPOSALS patient or prescriber to present a prescription by mail, by facsimile, or through a digital image of the prescription that is sent via electronic mail.141 The Commission also decided at that time not to include ‘‘substantially equivalent future technologies’’ within the scope of acceptable direct presentation mechanisms.142 In doing so, the Commission noted that section 4(a)(1) of the Act did not expressly reference or contemplate future technologies and the Commission was not aware of other technologies that met the statutory standard. The Commission declined at that time to include future technologies that ‘‘do not involve an exact copy of the prescription within the scope of acceptable direct presentation mechanisms.’’ 143 Since implementation of the Rule in 2004, technological advances— including many spurred by federal and state health information technology initiatives 144—have fostered the proliferation of patient portals, through which health care providers can securely share medical information, such as prescription information, directly with patients and certain third parties. The use of patient portals for presentation of contact lens 141 69 FR at 40495. The Commission also concluded that presentation of the prescription information from the consumer to the seller by telephone or by email (other than an email containing a digital image of the prescription) did not meet the ‘‘directly or by facsimile’’ standard imposed by the Act. 142 Id. 143 Id. 144 Numerous federal and state programs have been designed to foster the development of health information technology and the electronic processing, storage, and transmission of patients’ health information. For example, under the HITECH Act of 2009—Title XIII and Title IV of Division B of the American Recovery and Reinvestment Act of 2009—Congress directed the Medicare and Medicaid programs to make direct payments to eligible healthcare professionals, hospitals, and certain other healthcare providers specifically to incentivize the adoption and meaningful use of electronic health records systems (EHRs). American Recovery and Reinvestment Act of 2009 (Recovery Act), Public Law 111–5, § 4101(a), 4101(b), and 4202 (2009) (Medicare incentives for eligible professionals, Medicare incentives for hospitals, and Medicaid provider payments, respectively). According to a recent report by the U.S. Department of Health & Human Services, more than $30 billion in such incentive payments were made between 2011 and 2015. U.S. Dep’t Health & Human Servs., Office of the National Coordinator for Health Information Technology, Report to Congress, ‘‘Update on the Adoption of Health Information Technology and Related Efforts to Facilitate the Electronic Use and Exchange of Health Information’’ 18 (2016), https://www.healthit.gov/ sites/default/files/Attachment_1_-_2-26-16_RTC_ Health_IT_Progress.pdf. Regarding patient portals in particular, see, e.g., U.S. Dep’t Health & Human Servs., Office of the National Coordinator for Health Information Technology, ‘‘ONC Patient Engagement Playbook,’’ https://www.healthit.gov/playbook/pe/ introduction/. VerDate Sep<11>2014 20:36 Dec 06, 2016 Jkt 241001 prescriptions to sellers may provide many benefits to consumers and competition. When using a portal, the patient or prescriber will have direct access to a current, exact copy of the contact lens prescription, reducing the chance that an inaccurate or expired prescription might be presented to the seller. The use of patient portals may also reduce costs for prescribers, patients, and sellers by making it easier and more efficient for patients to share and present contact lens prescriptions, and by reducing the number of verification requests placed on prescribers. Because of these potential benefits, the Commission has made an initial determination that the provision ‘‘directly or by facsimile’’ includes the use of online patient portals by patients and prescribers to present contact lens prescriptions to sellers. In doing so, the Commission notes that the use of a patient portal necessarily involves ‘‘an exact copy of the prescription within the scope of acceptable direct presentation mechanisms.’’ 145 The Commission seeks comment on this clarification and requests that commenters provide information about whether the Commission should consider any other issues related to the presentation of prescriptions to sellers. 2. ‘‘Verified by Direct Communication’’ Some individual commenters recommended that the Commission revise the Rule to remove verification by direct communication, and argued that the sale of contact lenses should be conditioned upon presentation of a written prescription by the consumer to the seller. These commenters noted that consumers are already being provided with a written prescription as required by the Rule, and that requiring prescribers to verify prescriptions with the seller as well was redundant, timeconsuming and burdensome.146 Other commenters noted that with electronic means such as email and phone cameras readily available, the consumer should be responsible for presenting the prescription to the seller rather than having the prescriber verify the prescription.147 Other commenters argued that contact lens prescriptions 145 69 FR at 40495. (Comment #5), Driscoll (Comment #67); Kirk (Comment #131); Kalman (Comment #150); Baur (Comment #170); Bricker (Comment #195); Ahn (Comment #215); Comer (Comment #221); Kubo (Comment #234); Sanders (Comment #235); Williston (Comment #252); Campbell (Comment #348); Falcon (Comment #505); Walton (Comment #543). 147 Kiener (Comment #74); Kubo (Comment #234); McWilliams (Comment #362); Falcon (Comment #505); Pham (Comment #641). 146 Carroll PO 00000 Frm 00014 Fmt 4701 Sfmt 4702 should be treated the same way as prescriptions for medications, and that consumers should only be able to obtain contact lenses by presenting a written prescription.148 Some commenters also stated that relying on a written prescription to dispense lenses, rather than prescriber verification, would close loopholes in the verification framework that may allow consumers to obtain lenses without a valid, unexpired prescription.149 The language of Section 315.5(a)(2) was taken verbatim from the Act.150 Because Congress decided to structure the prescription verification framework to allow for either the direct presentation of a prescription to a seller or, alternatively, the verification of a prescription by direct communication, elimination of verification by direct communication is beyond the scope of this rule review. 3. Automated Telephone Calls as a Method of Direct Communication The Commission received numerous comments objecting to contact lens sellers’ use of automated telephone calls as a method to communicate verification requests.151 These commenters, who often refer to these automated telephone calls as robocalls, are largely prescribers, students of optometry, and associations whose members are prescribers. Commenters described problems arising from the use of automated telephone calls,152 and some 148 Driscoll (Comment #67); Moody (Comment #92); Filandro (Comment #129); Kirk (Comment #131); Kalman (Comment #150); Boyer (Comment #246); Bolenbaker (Comment #357). 149 Driscoll (Comment #67); Dieckow (Comment #151); Ahn (Comment #215); Sanders (Comment #235); Smith (Comment #319). 150 69 FR at 40495; see also 5 U.S.C. 7603(a). 151 The American Optometric Association pointed to the public’s general disfavor of robocalls, noting that they are commonly understood to be an abuse of telephone communication, one for which companies have been fined millions of dollars. Comment #644. The FTC disagrees with this characterization of automated seller verification calls. Contact lens seller verification calls are not sales calls covered by the Telemarketing Sales Rule (‘‘TSR’’), 16 CFR 310, which prohibits certain robocalls. In addition, the TSR does not apply to most business-to-business communications. 16 CFR 310.6(b)(7). 152 E.g., Stahl (Comment #19); Lum (Comment #21); Peterson (Comment #22); Borsky (Comment #26); Matthews (Comment #25); Maanum (Comment #23); Chriqui (Comment #31); Hodes (Comment #42); Dodge (Comment #44); Virginia Optometric Association (Comment #46); Alabama Optometric Association (Comment #48); Howe (Comment #53); Iowa Optometric Association (Comment #79); Michigan Optometric Association (Comment #86); Mirkin (Comment #111); California Optometric Association (Comment #119); Hicks (Comment #256); Leach (Comment #257); Chang (Comment # 258); Pentacost (Comment #268); Easton (Comment #432); Koch (Comment #539); E:\FR\FM\07DEP2.SGM 07DEP2 Federal Register / Vol. 81, No. 235 / Wednesday, December 7, 2016 / Proposed Rules asabaliauskas on DSK3SPTVN1PROD with PROPOSALS commenters called for an outright ban of the use of such calls.153 A number of commenters indicate that the automated verification calls are difficult to understand or confusing 154 or do not provide all of the information required to be a valid request.155 Some Connecticut Association of Optometrists (Comment #560); Lueng (Comment #607); Wu (Comment #608); Vidulich (Comment #612); Lai (Comment #620); Coalition for Patient Vision Care Safety (Comment #621); Pechko (Comment #628); American Optometric Association (Comment #644); Rubow (Comment #649); Liu (Comment #656); Louie (Comment #657); Fong (Comment #669); Vo (Comment #673). 153 E.g., Virginia Optometric Association (Comment #16); Stahl (Comment #19); Lum (Comment #21); Peterson (Comment #22); Maanum (Comment #23); Matthews (Comment #25); Borsky (Comment #26); Chriqui (Comment #31); Hodes (Comment #42); Dodge (Comment #44); Alabama Optometric Association (Comment #48); Iowa Optometric Association (Comment #79); Michigan Optometric Association (Comment #86); California Optometric Association (Comment #119); Hicks (Comment #256); Leach (Comment #257); Chang (Comment # 258); Easton (Comment #432); New Mexico Optometric Association (Comment #211); Koch (Comment #539); Connecticut Association of Optometrists (Comment #560); Tennessee Association of Optometric Physicians (#575); Colorado Association of Optometrists (Comment #584); Lueng (Comment #607); Wu (Comment #608); Vidulich (Comment #612); Lai (Comment #620); Coalition for Patient Vision Care Safety (Comment #621); Pechko (Comment #628); American Optometric Association (Comment #644); Liu (Comment #656); Louie (Comment #657); Fong (Comment #669); Vo (Comment #673). 154 E.g., Stahl (Comment #19); Lum (Comment #21); Peterson (Comment #22); Borsky (Comment #26); Matthews (Comment #25); Maanum (Comment #23); Chriqui (Comment #31); Hodes (Comment #42); Dodge (Comment #44); Virginia Optometric Association (Comment #46); Alabama Optometric Association (Comment #48); Howe (Comment #53); Iowa Optometric Association (Comment #79); Michigan Optometric Association (Comment #86); Mirkin (Comment #111); California Optometric Association (Comment #119); Hicks (Comment #256); Leach (Comment #257); Chang (Comment # 258); Easton (Comment #432); Koch (Comment #539); Connecticut Association of Optometrists (Comment #560); Lueng (Comment #607); Wu (Comment #608); Vidulich (Comment #612); Lai (Comment #620); Coalition for Patient Vision Care Safety (Comment #621); Pechko (Comment #628); American Optometric Association (Comment #644) (stating they have often received complaints over the last ten years from optometrists that robocalls from 1–800 CONTACTS were difficult to understand); Rubow (Comment #649) (stating that if the entire recorded message is not completed within the allotted time on the answering machine, they then receive a message from an actual live person where the person speaks so fast that it requires playing back the message four or five times in order to get all the information); Liu (Comment #656); Louie (Comment #657); Fong (Comment #669);Vo (Comment #673). 155 Virginia Optometric Association (#46); Iowa Optometric Association (Comment #79) (stating robocalls too often provide incomplete information); Hicks (Comment #256); Pentacost (Comment #268) (stating automated messages start playing well before the voicemail begins recording so that the office does not catch the name of the patient or which company left the message); Connecticut Association of Optometrists (Comment #560) (stating robocalls too often provide incomplete information); Coalition for Patient VerDate Sep<11>2014 20:36 Dec 06, 2016 Jkt 241001 optometrists or state optometric associations, many of which consist of or represent small businesses,156 complain that these calls are too long and time consuming,157 disturb their practices, take time away from providing care and attention to their patients, and make the phone lines unavailable for their patients.158 Commenters explained that part of the reason the automated calls are so disruptive is that the caller continuously redials until a message is fully communicated.159 In response to the recurring disruption, one prescriber stated that his office simply ignores the robocalls.160 Other commenters mentioned that sellers provide the patient name several sentences into, or at the very end of, the verification request, making it difficult for prescribers’ offices to respond efficiently and to verify the prescription in real time.161 Some commenters also complained that the automated calls come during business hours when they Vision Care Safety (Comment #621) (stating robocallers leave voice messages without contact information and may be cut off before conveying in entirety the patient’s information); American Optometric Association (Comment #644) (stating they have often received complaints over the last ten years from optometrists that robocalls from 1– 800 CONTACTS did not include all of the necessary information to confirm a prescription). 156 E.g., Pennsylvania Optometric Association (Comment #46); Iowa Optometric Association (Comment #79); Connecticut Association of Optometrists (Comment #560); Tennessee Association of Optometric Physicians (Comment #575); Rubow (Comment #649). 157 E.g., Stahl (Comment #19); Lum (Comment #21); Peterson (Comment #22); Maanum (Comment #23); Matthews (Comment #25); Borsky (Comment #26); Iowa Optometric Association (Comment #79); Lai (Comment #620); Chriqui (Comment #31); Hodes (Comment #42); Dodge (Comment #44); Plumb (Comment #219); Hicks (Comment #256); Leach (Comment #257); Chang (Comment # 258); Easton (Comment #432); Koch (Comment #539); Tennessee Association of Optometric Physicians (#575); Lueng (Comment #607); Wu (Comment #608); Vidulich (Comment #612); Coalition for Patient Vision Care Safety (Comment #621); Pechko (Comment #628); Liu (Comment #656); Louie (Comment #657); Fong (Comment #669); American Optometric Association (Comment #644); Vo (Comment #673). 158 Easton (Comment #432); Louie (Comment #657). See also Iowa Optometric Association (Comment #79) (explaining the need to protect small businesses from disruptive calls that interfere with treating patients and tie up phones); Pham (Comment #232); Tennessee Association of Optometric Physicians (Comment #575); Michigan Optometric Association (Comment #86). 159 See, e.g., Wisconsin Optometric Association (Comment #30); Pennsylvania Optometric Association (Comment #46); New Mexico Optometric Association (Comment #211); Tennessee Association of Optometric Physicians (Comment #575). 160 Scolin (Comment #369). 161 Brauer (Comment #68); Kalman (Comment #150); Egger (Comment #163); Plumb (Comment #219); Rosemore (Comment #468). PO 00000 Frm 00015 Fmt 4701 Sfmt 4702 88539 are busy with patients.162 Meanwhile, other commenters complain that the calls come in during non-business hours, and express concern that as a result, sellers may release the contact lenses to patients without the prescriber having time to confirm the prescription.163 Due to the aforementioned problems with automated telephonic verification requests, the Coalition for Patient Vision Care Safety asserted that prescribers are often unable to provide the proper verification of the patient’s prescription information within eight business hours, triggering the passive verification. As a result, patients may receive contact lenses based on outdated or incorrect prescription information.164 The Coalition stated that ‘‘the fact that patients are receiving contact lenses based on incorrect, outdated, or unverified prescription information runs counter to the FDA’s medical device safety standards, and can also lead to serious vision issues.’’ 165 On the other hand, 1–800 CONTACTS requested the Commission retain the use of automated phone systems as an acceptable form of direct communication for verification purposes. It argued that changing the status quo would be ‘‘unjustified, contrary to congressional intent and not in the interest of consumers.’’ 166 According to 1–800 CONTACTS, it has experimented with other forms of direct communication and concluded that ‘‘a well-functioning automated system that incorporates the latest technology is the most efficient means of handling the large volume of verification requests that are required today.’’ 167 1–800 CONTACTS indicated it has invested significant resources into the development of a system that is less subject to human error, allows accurate information to be given consistently to every prescriber, and provides assurance that it is compliant with the Rule. The company claimed that its system has an automated voice that is clear and easy to understand, and contains user-friendly options, such as the opportunity to pause the verification script or to request the system call back at a later time. 1–800 CONTACTS’ 162 See, e.g., Chang (Comment #126); Scolin (Comment #369); Tennessee Association of Optometric Physicians (#575). 163 Connecticut Association of Optometrists (Comment #560); Colorado Optometric Association (Comment #584). 164 Comment #621. See also Iowa Optometric Association (Comment #79); Chakuroff (Comment #189); Bricker (Comment #195); Spaeth (Comment #486). 165 Comment #621. 166 Comment #568. 167 Id. E:\FR\FM\07DEP2.SGM 07DEP2 88540 Federal Register / Vol. 81, No. 235 / Wednesday, December 7, 2016 / Proposed Rules comment also noted that, while its messages are automated, calls are initiated by live agents to guarantee that all calls are placed to the intended prescribers.168 1–800 CONTACTS also asserted that when a message is left on an answering machine, the live agent remains on the line during the entire automated message to ensure that the complete message is conveyed to the prescriber.169 According to 1–800 CONTACTS, each week it places approximately 100,000 calls to prescribers to verify prescriptions. The complete phone script for an automated verification call from 1–800 CONTACTS is 2 minutes, 29 seconds (149 seconds) in length, and prescribers familiar with the system have the option to skip the first 48 seconds of the message to reduce the total time of the message to 1 minute, 41 seconds (101 seconds). 1–800 CONTACTS indicated that the average prescriber receives only one verification request per week from the company,170 and the highest volume office in its records received, on average, six verification requests per week in 2014.171 The company explained that it places verification calls as it receives orders, and that it receives orders 24 hours a day, seven days a week, with many orders coming in on weekends or during evening hours. The company further explained that it leaves verification messages shortly after its receipt of orders because a continuous call process is ‘‘logistically efficient and prevents a shipping bottleneck at a single hour each day.’’ 172 Regardless of when it places the verification call to the prescriber, however, 1–800–CONTACTS stated that it never ships an order under the passive verification system before passage of eight business hours. The company added that in almost 30% of verification requests, prescribers hang up on verification calls.173 The Commission did not receive other comments from contact lens sellers about their use of automated verification systems to verify prescriptions.174 Consumers Union, the policy and advocacy division of Consumer Reports, also commented in support of automated calling systems, stating that such systems, of which eye doctors should now be aware, are a reasonable means for a retailer to efficiently handle a large volume of prescription requests. Consumers Union also stated that most eye doctors’ offices have automated answering systems and it believed they could set up an efficient means for recording the verification request information without significant burden.175 The Act expressly authorizes sellers to send prescription verification requests by direct communication 176 and defines ‘‘direct communication’’ to include communication by telephone, facsimile, or electronic mail.177 In previously considering this issue, the Commission noted that telephone is commonly understood to include automated telephone systems. The Commission therefore concluded in the initial rulemaking that ‘‘it would thus seem to be contrary to Congressional intent to prohibit the use of this technology.’’ 178 Nevertheless, then and now, the Commission emphasizes that automated telephone systems must fully comply with all applicable Rule requirements in order to transmit valid verification requests. For example, any automated verification request must provide complete verification request information as required under section 315.5(b),179 and this information must be either received by a person on the telephone or otherwise received in full (e.g., all of the requisite information is left on a telephone answering machine). 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, or if it contains incomplete verification information. The seller must also allow eight business hours for the prescriber to respond. During the initial rulemaking in 2004, the Commission indicated that it would ‘‘continue to monitor whether 175 Comment asabaliauskas on DSK3SPTVN1PROD with PROPOSALS 169 Id. 170 However, if the call is not completed, 1–800 CONTACTS will call the prescriber again. Therefore, one verification request may result in more than one call. 171 Id. 172 Id. 173 Comment #187. See also Consumers Union (Comment #677) (calling prescriber hang-ups a reported problem). 174 Warby Parker, an online seller of eyeglasses, commented on its support of the use of automated phone systems as a form of direct communication for verification purposes. Comment #593. VerDate Sep<11>2014 #677. U.S.C. 7603(a)(2). 177 15 U.S.C. 7603(g). 178 69 FR at 40489. 179 When seeking verification of a prescription, the seller must provide the prescriber with: The patient’s full name and address; the contact lens power, manufacturer, base curve or appropriate designation, and diameter when appropriate; the quantity of lenses ordered; the date of patient request; the date and time of verification request; the name of a contact person at the seller’s company, including facsimile and telephone numbers; and, if the seller is counting the prescriber’s regular Saturday hours as ‘‘business hours,’’ a clear statement of the prescriber’s regular Saturday business hours. 16 CFR 315.5(b). 176 15 168 Id. 20:36 Dec 06, 2016 Jkt 241001 PO 00000 Frm 00016 Fmt 4701 Sfmt 4702 full, valid requests for verification of a prescription are being made through the use of automated telephone systems’’ and may revisit the issue ‘‘[i]f evidence demonstrates that sellers are not making valid verification requests but are providing consumers with contact lenses despite deficient requests.’’ 180 The comments submitted in this Rule review by optometrists, students of optometry, and their trade associations provide the Commission with some evidence that some prescribers are receiving incomplete or otherwise inadequate verification requests. In addition, the Coalition for Patient Vision Care Safety asserted there is substantial evidence that verification requests are deficient and the American Optometric Association claimed that problems with 1–800 CONTACTS’ automated verification systems are often reported by its members.181 However, commenters did not provide any empirical data regarding the frequency of these various practices, average or aggregate costs associated with automated calls in particular, or the number of illegal or otherwise deficient contact lens sales that result from such calls. Furthermore, the Commission lacks evidence indicating whether these problems occur with automated calls generally or are chiefly associated with only one or a small group of sellers. If the reported problems chiefly are associated with the practices or systems of a limited number of sellers, the Commission would consider education of, or enforcement against, such sellers, rather than an amendment to the Rule at this time.182 Incomplete or incoherent verification requests are not valid verification requests.183 However, a seller may not always realize that it has made an invalid request and, hence, might dispense lenses under an assumption of 180 69 FR at 40489. for Patient Vision Care Safety (Comment #621); American Optometric Association (Comment #644). 182 In fact, a number of state optometric associations note that the costs prescribers’ offices expend related to the Rule are most often due to incomplete or otherwise inadequate verification requests. Michigan Optometric Association (Comment #86); Wisconsin Optometric Association (Comment #30); Pennsylvania Optometric Association (Comment #46); Iowa Optometric Association (Comment #79); New Mexico Optometric Association (Comment #211). Thus, education and enforcement efforts to improve sellers’ compliance with the verification aspects of the Rule may have a large benefit for prescribers, without the need to prohibit automated verification calls. 183 69 FR at 40496 (‘‘The Commission emphasizes that the sale of contact lenses based on a verification request which does not contain all of the required information constitutes a Rule violation.’’). 181 Coalition E:\FR\FM\07DEP2.SGM 07DEP2 asabaliauskas on DSK3SPTVN1PROD with PROPOSALS Federal Register / Vol. 81, No. 235 / Wednesday, December 7, 2016 / Proposed Rules passive verification if the prescriber does not contact the seller within eight business hours of the invalid request. Accordingly, to prevent the improper dispensing of lenses, the Commission encourages prescribers to contact the seller in these circumstances to inform them that the request is invalid and state the basis for the invalidity. Once the prescriber communicates that the request is invalid and states the basis for the invalidity, the seller shall not fill the order. Alternatively, for incomplete requests, the Commission encourages prescribers, to the extent they are able, to complete the missing information in order to facilitate the dispensing of the contact lenses. The Commission is sensitive to the business concerns of the prescribers who complain about the burden and inconvenience they experience from the sellers’ use of automated telephone systems. However, the Commission has not seen convincing evidence that the volume of automated verification calls they receive each day presents a burden that is not outweighed by the competitive benefits of the Rule, or that these practices frequently result in illegal sales of contact lenses. If the Commission receives evidence of a compelling widespread problem, it may revisit its position on the use of automated verification requests.184 At this point, however, the Commission declines to prohibit the use of automated verification calls. Nevertheless, the Commission encourages sellers, to the extent possible, to consider whether they could alleviate some of the commenters’ concerns by modifying their automated telephonic verification procedures or, alternatively, by increasing the use of other permissible communication methods. The Commission also seeks additional information on possible modifications to the Rule that, short of prohibiting automated verifications calls, could address the issues raised by commenters relating to these calls. The Commission declines to restrict when sellers may place automated phone verification calls. As long as sellers are placing valid and complete verification requests, and are not shipping orders prior to active verification, or the passage of eight business hours, automated telephone 184 The Commission notes that since Congress expressly permitted telephone as a form of direct communication for verification, if the Commission were to prohibit automated telephone calls, more live communications might result. Such communications would not necessarily alleviate all of the concerns expressed by commenters and might cause more problems for sellers with a large volume of orders and/or a small amount of staff. VerDate Sep<11>2014 20:36 Dec 06, 2016 Jkt 241001 verification requests placed outside of a prescriber’s business hours comply with the Rule. Moreover, a review of the comments reveals that some prescribers object to calls during office hours, while others object to calls during evening and weekend hours. The Commission therefore does not propose, at this time, to limit the time period when sellers may place automated calls. B. Section 315.5(b)—Information for Verification Section 315.5(b) delineates the information required for a prescription verification request: (1) Patient’s full name and address; (2) the contact lens power, manufacturer, base curve or appropriate designation, and diameter when appropriate; (3) the quantity of lenses ordered; (4) the date of patient request; (5) the date and time of verification request; (6) the name of a contact person at the seller’s company, including facsimile and telephone numbers; and (7) if the seller opts to include the prescriber’s regular business hours on Saturday as ‘‘business hours’’ for purposes of computing the eight business hour calculation, a clear statement of the prescriber’s regular Saturday business hours. 1. Vendor Contact Information A few individual prescribers stated that they were unable to contact vendors in order to get additional information when the verification request was incomplete.185 The American Optometric Association also voiced concerns about the difficulty that prescribers have in reaching an individual at 1–800 CONTACTS to discuss prescription concerns.186 Several state optometric associations asserted that physician small businesses may spend significant time on hold or attempting to use various phone numbers or automated prompts to reach a live person. These commenters recommended that the Commission require larger contact lens retailers to make available more than one individual at a company to act as the contact person for physician questions and concerns.187 Commenters did not 185 Truong (Comment #55); Cervantes (Comment #479). 186 Comment #644. 187 Virginia Optometric Association (Comment #16); Wisconsin Optometric Association (Comment #30); Utah Optometric Association (Comment #39); Pennsylvania Optometric Association (Comment #46); Alabama Optometric Association (Comment #48); Iowa Optometric Association (Comment #79); Michigan Optometric Association (Comment #86); California Optometric Association (Comment #119); New Mexico Optometric Association (Comment #211); Mississippi Optometric Association (Comment #548); Ohio Optometric Association PO 00000 Frm 00017 Fmt 4701 Sfmt 4702 88541 explain the nature of the incomplete verification requests such that a live person was necessary to address the inadequacy of the request, nor did they elaborate upon the reasons why prescribers need to reach live persons at contact lens retailers to answer ‘‘questions and concerns.’’ The Commission declines to propose this Rule modification. The Rule requires that the seller provide the name of a contact person at the seller’s company, including facsimile and telephone numbers.188 In requiring a facsimile number as well as a telephone number, it is clear that the Act and the Rule intended to provide for direct communication, but not necessarily contemporaneous, live communication. The language of the Act and the Rule anticipates that some sellers will communicate with prescribers via live agents, but does not require it. Instead, the Act and the Rule allow sellers also to communicate with prescribers about verification requests via facsimile as well as voicemail. Furthermore, the Commission does not believe it is necessary to require large contact lens retailers to have more than one individual available for prescriber questions and concerns, as long as a contact person is ‘‘reasonably accessible to the prescriber.’’ 189 As discussed in the initial rulemaking, the vendor contact provision is intended to ensure that the prescriber is able to reach a responsible person at the seller’s company.190 No evidence was presented showing how often prescribers experience difficulty in obtaining reasonable access to a contact person at the seller’s company.191 Without such (Comment #556); Connecticut Association of Optometrists (Comment #560); North Carolina State Optometric Society (Comment #567); Tennessee Association of Optometric Physicians (Comment #575); Colorado Optometric Association (Comment #584); New Jersey Society of Optometric Physicians (Comment #595). 188 16 CFR 315.5(b)(6). 189 69 FR at 40497. 190 Id. The Rule also requires that during the eight-business-hour window, ‘‘the seller shall provide a reasonable opportunity for the prescriber to communicate with the seller concerning the verification request.’’ 16 CFR 315.5(c)(3). In the initial rulemaking, the Commission declined to articulate with specificity the equipment or personnel that sellers must have to handle verification requests, in order to give sellers the flexibility to determine the most effective and efficient means of providing the opportunity to communicate. Rather, the Commission promulgated the final Rule to require that sellers provide prescribers a ‘‘reasonable opportunity’’ for the prescriber to communicate with the seller. 69 FR 40499. 191 Likewise, the Commission did not receive evidence sufficient to show that the methods for communication offered by sellers do not provide prescribers with a reasonable opportunity to E:\FR\FM\07DEP2.SGM Continued 07DEP2 88542 Federal Register / Vol. 81, No. 235 / Wednesday, December 7, 2016 / Proposed Rules asabaliauskas on DSK3SPTVN1PROD with PROPOSALS evidence, the Commission cannot determine whether a modification of the Rule is necessary. Moreover, as discussed earlier,192 if a verification request is incomplete, the request is invalid. If the prescriber communicates to the seller within the Rule-specified deadline that the verification request or the prescription is invalid,193 the seller may not fill the prescription.194 It is not necessary to reach a live person to perform this function. Once alerted that a verification request is invalid and the reason for the invalidity, the burden falls on the seller to resolve the invalidity, if possible. In addition, in routine cases it would not be necessary to reach a live person in order to correct a prescription. Accordingly, the rulemaking record contains insufficient evidence to show that mandating a mechanism for contemporaneous live communications is necessary to carry out the Act. The American Optometric Association also urged the Commission to amend the Rule to require sellers to respond to prescriber questions within an eight-business-hour window, or cancel the sale without verification. The Association’s comment did not explain the types of concerns that prescribers need to discuss with live agents at contact lens retailers. This proposal would require that once a prescriber contacted a seller with concerns, the seller could not assume the prescription was verified. Instead, the seller would be required to personally contact the prescriber and discuss the concerns communicate with the seller about the verification request. 192 See supra Section IV.A.3. 193 If a prescriber deems a prescription invalid, the Rule requires that the prescriber specify the basis for the invalidity. 16 CFR 315.5(d). 194 In addition, Warby Parker proposed that the Commission include stronger language in the Rule to make clear that it is a violation for prescribers to respond to a verification request by stating that prescription information is incorrect when, in fact, it is not; or to respond to a verification request by stating that prescription information is inaccurate or invalid without providing the basis for the inaccuracy or invalidity of the prescription. Comment #593. The Rule already provides that if a prescriber indicates that a prescription is inaccurate or invalid, the prescriber shall specify the basis for doing so. A failure to do so violates the Rule. See 16 CFR 315.5(d). Further, falsely indicating that a prescription was inaccurate would essentially equal a failure to ‘‘correct’’ a prescription, as mandated by the Rule and therefore, also would be a violation. See id. The Commission does not believe it needs to clarify these prescriber obligations further. Warby Parker also proposed that the Commission clarify that it is a violation of the Rule for a prescriber to interfere, in any way, with a seller’s effort to verify a prescription. This proposal is not described in detail nor is the frequency of this problem supported with empirical evidence. The Commission therefore declines to propose this Rule modification. VerDate Sep<11>2014 20:36 Dec 06, 2016 Jkt 241001 within eight business hours, or cancel the sale.195 The Commission declines to propose this modification as well. As discussed above, neither the Act nor the Rule requires contemporaneous, live communication between prescribers and sellers. Furthermore, the Commission believes that such a requirement would undercut the Act’s passive verification framework. Such a mechanism could conceivably allow any prescriber to lodge a concern or question and thereby halt the passive verification mechanism. As discussed above, if the prescription verification request is incomplete or inaccurate, or if the prescription is expired or otherwise invalid, the prescriber may alert the seller. The seller cannot fill a prescription if the prescriber has indicated that the prescription is expired or otherwise invalid. 2. Prescribers’ Selection of Communication Mechanism A few commenters suggested that the prescriber should have the ability to choose the method of communication sellers use to communicate verification requests with their offices.196 One commenter stated that she requested a seller make all future verification requests through facsimile, but the seller, who sometimes made requests via facsimile, refused her request.197 A number of prescribers expressed a preference for sellers to use another type of communication to verify contact lens prescriptions, including facsimile or email.198 A few prescribers requested that sellers use live telephone calls to communicate with their offices.199 The concept of having prescribers select the communication method that the seller would use to verify a prescription (i.e. by telephone, fax, or online) was previously raised with the Commission 195 Comment #644. (Comment #129); Chakuroff (Comment #189); Stuart (Comment #635). 197 Chakuroff (Comment #189). 198 Mirkin (Comment #111) (stating that fax or email verifications are quick and easy to answer); Chang (Comment # 126) (requesting fax or email verification system); Filandro (Comment #129) (requesting sellers offer all offices fax option for verification requests); Koch (requesting use of fax); Rubow (Comment #649) (seeking a requirement that online retailers verify through a route that is intelligible, including fax or a live person). But see Hicks (Comment #256) (stating automated fax systems are difficult for their offices as the fax machine is in an area of the business that is not frequently used); Ambler (Comment #524) (complaining of receipt of poor quality faxes when the office is closed). 199 Mirkin (Comment #111); Hicks (Comment #256) (stating a simple, quick phone call is much easier and would result in faster turnaround times for the patients); Rubow (Comment #649). 196 Filandro PO 00000 Frm 00018 Fmt 4701 Sfmt 4702 during the initial rulemaking.200 As the Commission then determined, 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 use to submit verification requests.201 Nevertheless, nothing prevents a seller from honoring a prescriber’s request for a certain type of communication and the Commission suggests that sellers evaluate whether honoring such requests would increase the speed and efficiency of the verification process. C. Section 315.5(c)—Verification Events Section 315.5(c) sets forth the three circumstances under which a seller can consider a prescription ‘‘verified by direct communication’’ and proceed to sell contact lenses to its customer: (1) The prescriber confirms the prescription is accurate by direct communication with the seller; (2) the prescriber informs the seller through direct communication that the prescription is inaccurate and provides the accurate prescription; and (3) the prescriber fails to communicate with the seller within eight business hours after receiving a proper verification request from the seller.202 1. Passive Verification A number of commenters expressed the view that because contact lenses are restricted medical devices, they should not be dispensed unless the prescriber actively verifies the prescription.203 The Contact Lens Association of Ophthalmologists, for example, in arguing for the elimination of passive verification, stated that it ‘‘puts the health of consumers at risk and is inconsistent with regulatory practices for confirmation of the validity and accuracy of prescriptions for drugs and for other Class II and Class Ill medical devices.’’ 204 Other commenters expressed the concern that the passive verification framework can be manipulated and, therefore, does not adequately ensure that patients receive contact lenses in accordance with proper medical 200 69 FR at 40497. 15 U.S.C. 7603(g). 202 16 CFR 315.5(c). 203 California Optometric Association (Comment #119) (‘‘Contact lenses are medical devices. Therefore, it is reasonable to replace passive verification with active verification for contact lenses.’’); Weissman (Comment #50) (same); Bainbridge (Comment #152) (‘‘Start treating contact lenses like the medical devices they are and start respecting the clinical judgment of doctors.’’). 204 Comment #572. 201 See E:\FR\FM\07DEP2.SGM 07DEP2 Federal Register / Vol. 81, No. 235 / Wednesday, December 7, 2016 / Proposed Rules asabaliauskas on DSK3SPTVN1PROD with PROPOSALS oversight. For example, some commenters asserted that passive verification is problematic because patients, in some circumstances, may be able to obtain lenses by providing fictional or incorrect information to sellers.205 A common scenario relayed by commenters is that if the patient provides the seller with the name of a fictional prescriber and a fictional fax number, the prescription will be passively verified when there is no response within eight hours.206 Some prescribers reported instances where some patients were never seen by a prescriber, and apparently the consumer just pulled the prescriber information from a Web site in an attempt to get a prescription verified via passive verification.207 A few commenters reported that patients said they were instructed—by sellers—to use any optometrist name, or any facsimile number, in order to facilitate the order.208 A few commenters also complained that after they have flagged a verification request as invalid, some sellers try to game the system and trigger a passive verification by then repeatedly faxing the same verification request to the prescriber in the hopes that the prescriber will not have the opportunity to deny the verification 205 Wang (Comment #94) (discussing ‘‘deliberate attempts to evade verification with the knowledge that a lack of verification is equivalent to a prescription being verified’’); Anklin (Comment #107) (describing the use of incorrect or even falsified information); Filandro (Comment #129) (noting that patients can fax the request to their own home or email); Stewart (Comment #136) (patients are able to use any fax number); McCutchan (Comment #624) (describing use of fax numbers for practices that are no longer active). 206 Caughell (Comment #7); Truong (Comment #55); Navarro (Comment #117); Zierlein (Comment #123); Ammon (Comment #128); Ciszek (Comment #134); Lee (Comment #158); Ambrose (Comment #196); Ahmed (Comment #209); Dell (Comment #227); Williston (Comment #252); Pentecost (Comment #268); Smith (Comment #319); Makler (Comment #356); Bolenbaker (Comment #357); McWilliams (Comment #362); Diaz (Comment #380); Liebig (Comment #478); Balitski (Comment #485); Garcia (Comment #511); Loerzel (Comment #550); Pham (Comment #641); Lisenby (Comment #662). 207 Driesen (Comment #47); Howe (Comment #53); Cherian (Comment #89); Hosaka (Comment #240); Chavez (Comment #334); Ling (Comment #390); Redder (Comment #454); Nakasone (Comment #469); Ball (Comment #590); Heuer (Comment #467); Ostrom (Comment #489); Hartman (Comment #522); Milsky (Comment #559). 208 Sadeghian (Comment #242) (‘‘A number of patients tell me that it is common practice by these online contact lens companies to tell the consumer to leave [the consumer’s] fax number as the doctor’s fax so nobody would respond to their requests.’’); Alianiello (Comment #253) (‘‘I asked where he’s been buying contact lenses and he told me the online avenue he uses asked him for his doctor’s name, and when he told them he couldn’t spell my last name they told him to look in the phone book and give them a name of an optometrist and they’d take care of it.’’). VerDate Sep<11>2014 20:36 Dec 06, 2016 Jkt 241001 request again, and it will end up passively verified.209 In light of these concerns, some commenters concluded that the passive verification system is not working as intended to protect patient eye health and instead, recommended that all contact lens prescriptions be actively verified.210 One commenter recommended that the Rule be modified to prevent the shipping of contact lenses without active verification.211 Another commenter said that if the retailer has not received an image of the actual prescription, the seller should at least obtain some confirmation that the customer is genuinely a patient of the prescriber that is being contacted for verification.212 The Commission declines to propose these Rule modifications. Issues identical to these were raised during the initial rulemaking process in 2004, when commenters either opposed or expressed significant concern about the passive verification system imposed by the Act and the Rule.213 At that time, some commenters were concerned about the use of a passive verification system for prescription medical devices such as contact lenses. Other commenters, during the initial rulemaking, expressed concern that verification requests could be sent to the wrong prescriber and might be improperly filled via passive verification because the prescriber neglected to respond to it.214 The Commission responded to concerns about passive verification by finding that ‘‘[b]ecause Congress has decided to impose a passive verification system through the Act, whether to adopt a passive verification system is not at issue in this rulemaking proceeding.’’ 215 The same holds true today, and this rule review does not revisit the decision to include a passive verification system. With respect to concerns that patients are manipulating the passive verification system by deliberately providing inaccurate prescriber information, the Commission notes that 209 See, e.g., Christensen (Comment #149). (Comment #67); Diaz (Comment #380); Whittington (Comment #443). 211 Palmer (Comment #484). 212 Milsky (Comment #559). This commenter also proposed that in order to allow eye doctors and the Commission to be able to track in detail what happens to online orders after the verification request is sent, the seller should be required to inform the prescriber whether the transaction was cancelled or completed, and if so, what exactly was shipped and when. This mechanism would document whether lenses were shipped before any verification took place. 213 69 FR at 40497 and note 206. 214 69 FR at 40497 and note 198. 215 69 FR at 40497. 210 Driscoll PO 00000 Frm 00019 Fmt 4701 Sfmt 4702 88543 if prescribers receive verification requests for individuals who are not their patients, prescribers have the ability and incentive to respond that such requests are ‘‘invalid’’ under section 315.5(d) of the Rule,216 thus preventing an improper passive verification. With regard to concerns that patients are deliberately providing fictional prescriber information and fictional contact information, commenters produced only anecdotal evidence of such actions, and did not provide empirical data regarding the frequency of these activities. Although it is possible that such activities could allow some patients to obtain contact lenses without a valid prescription, the Commission notes that in doing so, such individuals are intentionally circumventing the Rule. As discussed above, the passive verification framework has been mandated by Congress in an effort to balance the interests of consumer health and prescription portability. At the time the Act was under consideration, Congress was aware—after being informed by the Commission and the American Optometric Association, among others— that passive verification was not a foolproof method for preventing the verification of invalid prescriptions.217 The Commission will consider consumer education efforts designed to encourage consumers to act responsibly, 216 Id. 217 See, e.g., ‘‘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) (Testimony of J. Pat Cummings, American Optometric Association) (testifying that ‘‘the problem with passive verification’’ is that some people will be able to get contact lenses without a prescription); id. (Testimony of Howard J. Beales, Federal Trade Commission) (noting that passive verification contains a risk that some contact lenses will be provided based on out-of-date prescriptions). Congress opted for passive verification after hearing repeated reports of the difficulties consumers confronted having prescriptions verified in states with active verification systems. See H.R. Report No. 108–318, at 5 (2003) (stating the Fairness to Contact Lens Consumers Act ‘‘adopts a passive verification system in order to best serve the consumer,’’ after hearing testimony from consumers and businesses of the ‘‘unusually high number of consumer complaints in states that rely on active verification schemes.’’). See also ‘‘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) (Testimony of Peggy Venable, Texas Citizens for a Sound Economy) (testifying that under an active verification system in Texas, there was a ‘‘widespread practice [by optometrists] of failing to verify the prescription’’); id. (Testimony of Jonathan C. Coon, 1–800 CONTACTS) (testifying that under active verification, 1–800 CONTACTS had to cancel half of all orders in Texas due to prescribers’ failure to respond to verification requests). E:\FR\FM\07DEP2.SGM 07DEP2 88544 Federal Register / Vol. 81, No. 235 / Wednesday, December 7, 2016 / Proposed Rules within the confines of the Rule. In addition, to the extent that the Commission receives evidence that sellers are encouraging consumers to provide inaccurate or fictional prescriber information, the Commission will investigate such allegations, as appropriate. #2. Issues Regarding the Eight-BusinessHour Window asabaliauskas on DSK3SPTVN1PROD with PROPOSALS Some commenters stated that the current eight-business-hour window is a reasonable length of time for prescribers to respond to verification requests.218 1– 800 CONTACTS, for example, asserted that the ‘‘eight business-hour time frame for passive verification gives prescribers sufficient time to confirm important health information and correct any inaccurate orders without imposing a needless delay on consumers who place a premium on quick delivery.’’ 219 As support, 1–800 CONTACTS stated that last year it cancelled orders worth approximately $40 million in response to communications from prescribers, and that the ‘‘number of deleted orders and the value of sales cancelled demonstrate that prescribers have more than adequate time to respond when necessary.’’ 220 Other commenters, however, argued that the eight-business-hour time frame for passive verification does not allow enough time for doctors to notify sellers that a prescription is expired, inaccurate, or nonexistent. The American Academy of Ophthalmology, for example, stated that the eightbusiness-hour requirement ‘‘is far too short and ultimately imposes significant burdens on providers and in many instances eliminates a necessary patient safety check.’’ 221 Some prescribers noted that their offices are very busy and that eight business hours was not enough time to verify prescriptions.222 The CLAO suggested that eight business hours was insufficient because 218 1–800 CONTACTS (Comment #568). See also Warby Parker (Comment #593) (‘‘Passive verification provides prescribers with a reasonable opportunity to verify, address or correct an inaccurate, invalid or expired prescription without imposing an undue burden on the prescriber. Furthermore, it gives the seller a reasonable endpoint at which to proceed with the sale. This ensures that prescribers do not thwart patient choice of where to purchase contact lenses by failing to verify a prescription and relegating the patient back to the prescriber for the ultimate purchase. We also believe that eight business hours is a reasonable length of time for passive verification.’’). 219 Comment #568. 220 Id. 221 Comment #611. 222 Tran (Comment #260); Bierwerth (Comment #308); Loerzel (Comment #550); Fink-Freeman (Comment #609). VerDate Sep<11>2014 20:36 Dec 06, 2016 Jkt 241001 ‘‘validation requests arrive with incomplete or erroneous patient information complicating the process by which clinical records are retrieved.’’ 223 These comments, however, did not quantify how the eight-business-hour time frame imposed ‘‘significant burdens’’ on providers, nor establish that a significant number of prescribers were unable to respond to verification requests within eight business hours. Commenters similarly failed to provide specific information quantifying the frequency of incomplete or incorrect validation requests. Many commenters did not propose a specific extension of time to respond to a verification request,224 and merely stated that eight business hours was not enough. Some commenters did put forth specific proposals, such as changing the language to ‘‘eight (8) business hours or twenty-four (24) clock hours, whichever is later,’’ 225 doubling the length of time to 16 hours,226 or extending the verification window to at least two business days.227 Others suggested providing at least 48 to 72 hours,228 or two to three business days,229 to confirm the validity of a prescription. A few commenters suggested that increasing the window to 72 hours would alleviate issues that arise when verifications are received on Friday, Saturday or Sunday.230 Having considered these comments, the Commission declines to propose a Rule modification lengthening the eightbusiness-hour timeframe during which a prescriber must respond to a verification 223 CLAO (Comment #572). (Comment #443) (‘‘more than eight hours to confirm the RX request’’); Heuer (Comment #467) (‘‘reasonable amount of time to respond’’). 225 Milsky (Comment #559) (‘‘That change would still not prevent the situation where, for example, a verification request comes in on a holiday weekend and the prescriber’s office is closed for an extra day off, or when a practice is not open on Wednesdays, but at least it would mean that the prescriber would have a little more of an opportunity (especially at the beginning or end of the workday) to correct any errors in the verification request, before the order is shipped and it’s too late.’’). 226 Kiener (Comment #74); Perala (Comment #315); Diaz (Comment #380). 227 CLAO (Comment #572); Koury (Comment #573); Fink-Freeman (Comment #609); American Academy of Ophthalmology (Comment #611). See also Hua (Comment #45) (recommending an increase to 24 to 48 hours); Bhadra (Comment #105) (same). 228 Gooderman (Comment #10); Galdamex (Comment #167) (at least 72 hours); Lin-Dilorinzo (Comment #476); Espy (Comment #587). 229 Voight (Comment #551); Figazolo (Comment #24) (three days); Truong (Comment #55) (three days). 230 Yaklich (Comment #364); Raff (Comment #373). See also Coalition for Patient Vision Safety (Comment #621). 224 Whittington PO 00000 Frm 00020 Fmt 4701 Sfmt 4702 request. Despite comments that the timeframe is too short, the Commission believes that the current eight-businesshour time frame is adequate for the vast majority of prescribers. Commenters put forth no empirical evidence that prescriptions are being improperly verified via passive verification due to prescribers not having enough time to respond, and cited no compelling changes in the marketplace that would justify extending the time frame beyond eight business hours. If anything, because of advances in technology, electronic communications, and recordkeeping, eight business hours is as appropriate, if not more so, than when implemented in 2004. As the Commission explained in the initial rulemaking, ‘‘Congress recognized that consumers may be harmed if they face undue delays in receiving their contact lenses from a seller’’ and balanced that consideration against the possible harm consumers may experience if sellers provide contact lenses based on invalid prescriptions.231 The Commission has found nothing thus far in the record for this rule review proceeding to disturb that determination. In addition to concerns about the time prescribers have to respond, some commenters expressed concern about when verification calls are placed and received. Some optometrists expressed concern that some sellers are exploiting the Rule by placing verification requests after hours in order to circumvent the eight-business-hour window.232 Other prescribers noted with frustration that sellers fax verification requests outside of normal business hours, such as in the middle of the night or on weekends, thereby making it impossible for them to respond in a timely fashion.233 Some commenters complained that because they only had 24 hours to respond to a 231 69 FR at 40482. (Comment #200) (‘‘[u]nder the current law, retailers are allowed to fill a prescription if verification is not received within 8 hours. This is commonly exploited by faxing or robodialing verification requests outside of normal business hours, then filling the prescription before the prescriber responds.’’). See also Stahl (Comment #19); Lum (Comment #21); Peterson (Comment #22); Maanum (Comment #23); Matthews (Comment #25); Borsky (Comment #26); Hodes (Comment #42); Dodge (Comment #44); McBride (Comment #171); Sloan (Comment #177); Kirkconnell (Comment #202); Hamilton (Comment #216); Leach (Comment #257); Chang (Comment #258); Yaklich (Comment #364); Leung (Comment #607); Wu (Comment #608); Vidulich (Comment #612); Lai (Comment #620); Pechko (Comment #628); Liu (Comment #656); Louie (Comment #657); Fong (Comment #669); Vo (Comment #673). 233 Plumb (Comment #219); St. Martin (Comment #292); Diaz (Comment #380); Witmeyer (Comment #418); Nakasone (Comment #469); Garcia (Comment #511); Egbert (Comment #515); Steinleitner (Comment #517). 232 Berger E:\FR\FM\07DEP2.SGM 07DEP2 Federal Register / Vol. 81, No. 235 / Wednesday, December 7, 2016 / Proposed Rules asabaliauskas on DSK3SPTVN1PROD with PROPOSALS verification request,234 such verifications would be confirmed automatically over the weekend because no one was in the office.235 Other commenters noted that they receive verification faxes outside of normal business hours and therefore have no way of verifying, denying, or correcting prescriptions.236 Many of these commenters recommended that the Rule be amended to prohibit sellers from sending prescription verifications after business hours and on weekends.237 Along the same lines, the Coalition for Patient Vision Safety recommended that the Commission modify ‘‘the eighthours of communication when the initial communication begins prior to a holiday or on a weekend when the doctor is not conducting normal office hours.’’ 238 At this time, the Commission does not propose to amend the Rule to prohibit sellers from sending prescription verification requests after business hours and on weekends or to otherwise extend the eight-business-hour window to account for weekends and holidays. It appears that the majority of commenters suggesting this prohibition are concerned that they do not have the opportunity to verify a prescription because they believe the eight-businesshour window for verification of a contact lens order is triggered upon receipt of a verification request, no matter when that request is received. That concern is misplaced. Section 234 Whipple (Comment #15); Huang (Comment #17); Wilson (Comment #76); Green (Comment #162); Frederick (Comment #207); Zair (Comment #512). 235 Magee (Comment #95); Mueller (Comment #513); Born (Comment #570); Shugarman (Comment #266). 236 Glavine (Comment #62); Tolchin (Comment #194); Bricker (Comment #195); Ahn (Comment #215); Lester (Comment #231); Kegarise (Comment #447). 237 California Optometric Association (Comment #119); Stahl (Comment #19); Lum (Comment #21); Peterson (Comment #22); Maanum (Comment #23); Matthews (Comment #25); Borsky (Comment #26); Chriqui (Comment #31); Hodes (Comment #42); Dodge (Comment #44); Loydall (Comment #225); Leach (Comment #257); Chang (Comment #258); Liebig (Comment #478); Harris (Comment #490); Leung (Comment #607); Wu (Comment #608); Vidulich (Comment #612); Lai (Comment #620); Pechko (Comment #628); Liu (Comment #656); Louie (Comment #657); Fong (Comment #669); Vo (Comment #673). 238 Comment #621. Similarly, some commenters suggested increasing the eight-business-hour window because, based on their apparent misunderstanding of how the eight business hours are calculated, they believed that they did not have enough time to respond to verification requests received after business hours and on weekends. See Mirkin (Comment #111); Kalman (Comment #150); Bender (Comment #164); Hans (Comment #168); Baur (Comment #170; Yaklich (Comment #364); Raff (Comment #373); Diaz (Comment #380); Kegarise (Comment #447); Heuer (Comment #467); Zair (Comment #512); Gandhi (Comment #588). VerDate Sep<11>2014 20:36 Dec 06, 2016 Jkt 241001 315.2 of the Rule provides that ‘‘[f]or verification requests received by a prescriber during nonbusiness hours, the calculation of ‘eight (8) business hours’ shall begin at 9 a.m. on the next weekday that is not a Federal holiday or, if applicable, on Saturday at the beginning of the prescriber’s actual business hours.’’ 239 Other commenters expressed frustration that verification requests were sent after regular business hours with the statement that the prescription would be filled unless the prescriber contacted the seller within 12 to 24 hours.240 Depending upon when these requests are sent, these sellers’ practices could result in contact lenses being shipped before or after the end of the eight-business-hour window. To the extent that sellers are dispensing contact lenses prior to the end of the eightbusiness-hour window, the Commission notes that this practice violates the Rule. If the Commission receives evidence that sellers are dispensing contact lenses before the end of the eight-businesshour window, the Commission will investigate such allegations, as appropriate. A few commenters expressed concern that some prescriptions were being automatically filled without a prescriber’s oversight because the calculation of an eight-business-hour window does not take into consideration the fact that their offices may not be open or able to verify prescriptions during the Rule’s established timeframe for business hours.241 For example, an office may be closed due to vacation, inclement weather, or regularly scheduled office closures that occur during the normal workweek.242 239 See also 69 FR at 40486. (Comment #17); Magee (Comment #95); Green (Comment #162); Shugarman (Comment #266). 241 A small number of commenters complained that they regularly received verification requests from sellers that state that their records indicate that the prescriber has Saturday business hours. See Alianiello (Comment #253); Raff (Comment #373). These commenters said that despite correcting this misimpression, the seller continued to send verification requests that would begin the eightbusiness-hour window on Saturday morning. The Commission reiterates that this is a Rule violation because the seller only may count Saturday hours as business hours if the seller has actual knowledge of the prescriber’s Saturday business hours. Here, the seller has actual knowledge to the contrary. 69 FR at 40485. If the Commission receives evidence of such practices, the Commission will investigate such allegations, as appropriate. 242 Robins (Comment #165); Glassband (Comment #218); Kubo (Comment #234); Whang (Comment #355); Makler (Comment #356); Falcon (Comment #505); Manuel (Comment #508); Voight (Comment #551); Koury (Comment #573); Kowaleski (Comment #578). 240 Huang PO 00000 Frm 00021 Fmt 4701 Sfmt 4702 88545 Similar concerns were raised by commenters in the initial rulemaking in 2004. At that time, the Commission declined to adopt an actual hours or other prescriber-specific approach to business hours, noting that ‘‘[i]t likely would be difficult and burdensome— perhaps impossible—for some sellers to determine and keep track of the actual hours of 50,000 prescribers. By contrast, a general rule using a uniform definition of business hours for all prescribers provides clarity and relative ease of compliance and enforcement.’’ 243 In addition, the Commission recognized that there ‘‘does not appear to be any practical way to accommodate the myriad circumstances during which the offices of 50,000 individual prescribers may be closed or otherwise not able to respond to a prescription verification request.’’ 244 The Commission continues to believe that such an approach would be impractical and declines to propose an actual hours or other prescriberspecific approach to calculating business hours. V. Contact Lens Prescriptions A. Section 315.6—Expiration of Contact Lens Prescriptions As set forth by Section 315.6(a) of the Rule, a contact lens prescription expires 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.245 If State law specifies no date or specifies a date less than one year after the issue date of the prescription, the Rule provides that the prescription shall not expire less than one year after the issue date of the prescription.246 A prescriber, nonetheless, can specify a shorter expiration date if that date is ‘‘based on the medical judgment of the prescriber with respect to the ocular health of the patient.’’ 247 The prescriber then must document the reasons in the patient’s medical record.248 In other words, contact lens prescriptions cannot expire in less than one year unless, based on medical judgment, a prescriber specifies a different date and documents the 243 69 FR at 40484. 244 Id. 245 16 CFR 315.6(a)(1). The majority of states require that a contact lens prescription not expire less than one year after the issue date, except when a special medical circumstance necessitates that it expire sooner. A few states, such as Maryland and Washington, require that contact lens prescriptions not expire less than two years after the issue date except for special medical circumstances. See, e.g., Maryland Code § 11–404.4; Wash. Admin. Code § 246–852–010 (1)(f). 246 16 CFR 315.6(a)(2). 247 16 CFR 315.6(a)(3). 248 16 CFR 315.6(b)(1). E:\FR\FM\07DEP2.SGM 07DEP2 88546 Federal Register / Vol. 81, No. 235 / Wednesday, December 7, 2016 / Proposed Rules reasoning. The language of these Rule provisions closely tracks that of the Act.249 1. Length of Contact Lens Prescriptions The Commission received several comments about the length of contact lens prescriptions. Some commenters expressed the view that the prescription length should be longer. For example, Consumers Union requested that the Commission ‘‘consider whether a longer minimum period is warranted in the best interests of the consumer.’’ 250 One consumer commented that contact lens prescriptions should be at least two years in length.251 The Professional Opticians of Florida recommended that the Commission modify the Rule to prohibit the use of expiration dates on prescriptions for adult patients with low risk factors,252 while an optometrist argued that, ‘‘[c]ompetition for the sales of contact lenses is so great that placing any regulations on the length of the prescription is unnecessary and should be at the sole discretion of the prescriber.’’ 253 LD Vision Group, a contact lens retailer, declared that while it generally makes sense for patients to undergo a comprehensive eye examination to ensure good eye health, patients should not have to undergo a follow-up contact lens fitting after receiving a trial pair of contact lenses from a prescriber.254 Furthermore, according to that commenter, patients should be able to waive the requirement that their contact lens prescriptions be verified—and yet still be able to obtain contact lenses—by acknowledging that they are aware of the risks of not obtaining an annual eye examination.255 However, many commenters, primarily prescribers, urged the Commission not to ‘‘deregulate’’ prescription length 256 or otherwise extend the length of contact lens prescriptions.257 Other prescribers 249 15 U.S.C. 7604. #677. 251 Schodowski (Comment #65). 252 Comment #563. 253 Bolenbaker (Comment #357). 254 LD Vision Group (Comment #544). 255 Id. 256 Wood (Comment #37); Compton (Comment #275); Singhai (Comment #281). 257 See, e.g., Morgan (Comment #144); Stoliker (Comment #286); Parikh (Comment #288); Shlosman (Comment #290); Lee (Comment #293); Paulsen (Comment #296); Turano (Comment #303); Yang (Comment #307); Daniel (Comment #310); Huynh (Comment #313); Stetson (Comment #314); Theroux (Comment #317); Wong (Comment #330); Tarr (Comment #344); Peres-Maes (Comment #346); Dronka (Comment #347);Scott (Comment #354); Cantor (Comment #358); Cesar (Comment #359); Philippe (Comment #365); Geller (Comment #370); Uchida (Comment #403); Sharma (Comment #404): asabaliauskas on DSK3SPTVN1PROD with PROPOSALS 250 Comment VerDate Sep<11>2014 20:36 Dec 06, 2016 Jkt 241001 encouraged the Commission to retain the one-year prescription length, citing the importance of annual eye examinations for preventing complications related to contact lens use, diagnosing other conditions by examining the eyes, and providing patient education about contact lens use.258 A few commenters expressed satisfaction with the two-year prescription length imposed by some States’ laws.259 The Commission declines to propose any changes—either removing or lengthening—the Rule’s prescription length provisions. As indicated above, the Rule’s language closely tracks that of the Act, which set a minimum expiration date ‘‘to prevent prescribers from selecting a short expiration date for a prescription that unduly limits the ability of consumers to purchase contact lenses from other sellers, unless medical reasons justify setting such an expiration date.’’ 260 Accordingly, the Commission is not at liberty to remove the prescription expiration provision. In addition, the Commission declines to propose to lengthen the Rule’s prescription expiration provisions and believes the current framework is appropriate. As the Commission concluded in response to commenters arguing for a minimum expiration date of two years during the initial rulemaking, in drafting the Act, Congress intended to defer to applicable State law except where such law establishes an expiration period of less than one year.261 Nguyen (Comment #412); Eng (Comment #414); Frady (Comment #440); Santhanam (Comment#444); Calhoun (Comment #446); Howard (Comment #453); Desai (Comment #462); Douglas (Comment #526); Geiger (Comment #598); Ancona (Comment #650); Webster (Comment #670). 258 See, e.g., Coalition for Patient Vision Care Safety (Comment #621);Williford (Comment #38); Kapoor (Comment #58); Anderson (Comment #96); Tse (Comment #146); Morrison (Comment #239); Major (Comment #263); Uy (Comment #277); Williams (Comment #261); Walker (Comment #283); Murray (Comment #287); Rice (Comment #295); Harris (Comment #305); Cluff (Comment #309); Hollister (Comment #318); Oliver (Comment #323); Gelman (Comment #326); Cox (Comment #336); Zimmerman (Comment #372); Sherman (Comment #375); Klein (Comment #377); Hafford (Comment #383); Blankenship (Comment #395); Elmore (Comment #396); Assell (Comment #397); Yaryan (Comment #401); Stefanovic (Comment #417); Enochs (Comment #423); Moore (Comment #437); Archibald (Comment #438); Lott (Comment #445); Goller (Comment #448); Eggers (Comment #473); Abbott (Comment #497); Nazario (Comment #518); Neuenfeldt (Comment #542); Maino (Comment #555); Bieter (Comment #602); Lac (Comment #631); Bandy (Comment #643); Lee (Comment #659); Alexander (Comment #666). 259 Hua (Comment #45); Campbell (Comment #348). 260 69 FR at 40504; 69 FR at 5443. 261 69 FR at 40504. PO 00000 Frm 00022 Fmt 4701 Sfmt 4702 2. Expired Contact Lens Prescriptions A number of prescribers reported that some of their patients are obtaining contact lenses through online vendors even though their contact lens prescriptions have expired.262 According to Johnson & Johnson Vision Care, Inc., ‘‘roughly one-in-three online contact lens purchasers’’ surveyed in a 2015 APCO Insight online survey ‘‘admit[ted] to ordering lenses using an already expired prescription.’’ 263 In response to these concerns, some commenters recommended that the Commission amend the Rule specifically to prohibit the sale of contact lenses to patients with expired prescriptions.264 After reviewing the comments, the Commission has determined that no amendment is necessary because the current regulatory framework sufficiently prohibits the use of expired prescriptions. As a threshold matter, Section 4(e) of the Act and Section 315.5(d) of the Rule clearly identify three categories of invalid prescriptions (inaccurate, expired, and otherwise invalid).265 Accordingly, the Act and the Rule already make explicit that an expired prescription is not a valid prescription. Under the Rule, sellers may only dispense lenses using either a prescription that has been presented to the seller, or a prescription that has been verified with the prescriber by the seller.266 A prescription presented to the 262 See, e.g., Williford (Comment #38); Glavine (Comment #62); Jones (Comment #63); Copeland (Comment #73); Weinberg (Comment #87); Moody (Comment #92); Buthod (Comment #81); Kreda (Comment #93); Magee (Comment #95); Voreis (Comment #114); Navarro (Comment #117); Taylor (Comment #120); Dyak (Comment #124); Stewart (Comment #136); Madden (Comment #155); Robertson (Comment #180); Chakuroff (Comment #189); Law (Comment #190); Burruss (Comment #192); Bricker (Comment #195); Stephens (Comment #210); Sadeghian (Comment #242); Pentecost (Comment #268); Shaw (Comment #339); Chea (Comment #352); Steinleitner (Comment #517); Holler (Comment #553); Song (Comment #654). 263 Comment #582 (emphasis deleted). The survey, conducted on behalf of Johnson & Johnson Vision Care, Inc. included 500 contact lens users 18 years of age or older who had purchased contacts online in the prior six months. See also Coalition for Patient Vision Care Safety (Comment #621) (referencing 2015 APCO Insight Survey). 264 Stahl (Comment #19); Lum (Comment #21); Peterson (Comment #22); Maanum (Comment #23); Matthews (Comment #25); Borsky (Comment #26); Chriqui (Comment #31); Hodes (Comment #42); Dodge (Comment #44); Ellingson (Comment #66); Leach (Comment #257); Chang (Comment #258); Leung (Comment #607); Wu (Comment #608); Vidulich (Comment #612); Lai (Comment #620); Pechko (Comment #628); Liu (Comment #656); Louie (Comment #657); Fong (Comment #669); Vo (Comment #673). 265 15 U.S.C. 7603(e); 16 CFR 315.5(d). See also 69 FR at 40502. 266 16 CFR 315.5(a). E:\FR\FM\07DEP2.SGM 07DEP2 Federal Register / Vol. 81, No. 235 / Wednesday, December 7, 2016 / Proposed Rules seller must contain an expiration date in order to satisfy the definition of contact lens prescription.267 If the prescription presented to, or in possession of, the seller is expired, that prescription is invalid and the seller cannot use the expired prescription to dispense lenses to the patient. Because the seller has actual knowledge that the prescription is expired, neither may the seller use the expired prescription as the basis for a passive verification request. If, however, a seller has been presented with, or is in possession of, a prescription that does not contain an expiration date, or is otherwise relying on prescription information provided by the patient, then the seller may proceed to verify such prescription with the prescriber.268 In this latter instance, the seller does not have any knowledge as to whether or not the prescription is expired, and can rely on the prescriber to alert the seller if the prescription is expired. Other commenters, recognizing that selling contact lenses on an expired prescription is not allowed by the Rule, instead urged the Commission to increase enforcement.269 The Commission believes that the clarification regarding expired prescriptions as set forth in this document will assist sellers in understanding their obligations under the Rule. In addition, if the Commission receives evidence that sellers are dispensing contact lenses based on expired prescriptions, the Commission will investigate such allegations, as appropriate. Other commenters explained that because of flaws in the passive verification system sellers ‘‘can request verification of an otherwise expired prescription and can ship the lenses if the prescriber does not recognize within eight business hours that the expiration date has passed and inform the seller.’’ 270 In its comment, the Contact Lens Association of Ophthalmologists argued that passive verification ‘‘creates a mechanism for renewal of expired prescriptions, which is in the seller’s interest, may be in the consumer’s immediate interest, but is not in the 267 16 CFR 315.2. CFR 315.5(a)(2). 269 See, e.g., Peterson (Comment #222); Smith (Comment #319); Heuer (Comment #467); Santarias (Comment #471); Johnson & Johnson Vision Care, Inc. (Comment #582) (‘‘critical to ensure patients continue to see their eye care professionals for their annual check-up and prescription renewal by upholding and enforcing the one-year contact lens prescription expiration date’’); Coalition for Patient Vision Care Safety (Comment #621). 270 American Optometric Association (Comment #644). See also Stewart (Comment #136) (stating that expired prescriptions have been filled for years because there was no reply to passive verification). asabaliauskas on DSK3SPTVN1PROD with PROPOSALS 268 16 VerDate Sep<11>2014 20:36 Dec 06, 2016 Jkt 241001 interest of the consumer’s long term ocular health.’’ 271 In its comment, the American Optometric Association noted that ‘‘an expiration date and issue date are required elements of a prescription’’ and the FTC ‘‘should require the expiration date or issue date to be provided in prescription verification.’’ 272 This commenter argued that this requirement would incentivize sellers to make sure patients know their prescription expiration date when placing orders. The American Optometric Association further explained that because sellers often market to consumers to reorder in the final month or weeks that the prescription is valid, it believes that sellers already know the prescription expiration date.273 This commenter concluded that by requiring the expiration date or issue date in the verification request, sellers would be aware, and could not deny when they are using an invalid prescription.274 The Commission declines to propose that the Rule be modified in this way. Similar proposals were suggested and rejected during the initial rulemaking.275 As the Commission recognized at that time, there is ‘‘no reason to believe or evidence to suggest that a seller who is attempting to verify a prescription would necessarily have this information.’’ 276 Furthermore, the Commission believes that adopting such a proposal might thwart the intent of the Act. For example, although prescribers themselves have the prescription expiration information because they issued the prescription, a seller verifying a prescription—as opposed to a seller who has a copy of a prescription with an expiration date—may not have access to this information. Because a verification request that does not contain all the required information is not a valid verification request,277 sellers without expiration information would be at a disadvantage in that they would not be able to verify patient 271 Comment #572. See also American Optometric Association (Comment #644) (‘‘[a]llowing repurchases based on long-expired prescriptions may be, at the time, convenient for the patient and profitable for the seller, but increases the risk of patient harm’’). 272 American Optometric Association (Comment #644). 273 Id. 274 Id. 275 A state optometry association requested that the Rule be amended to require the verification request to contain the prescription’s expiration date as well as the number of refills prescribed. 69 FR at 40496. 276 Id. 277 Id. (‘‘The Commission emphasizes that the sale of contact lenses based on a verification request which does not contain all of the required information constitutes a Rule violation.’’). PO 00000 Frm 00023 Fmt 4701 Sfmt 4702 88547 prescriptions based on Section 315.5(c)(3). Furthermore, as noted, prescribers are already in possession of the expiration date, and it is in their economic and professional interest to check the prescriptions and respond to verification requests by informing the seller whenever a prescription has expired.278 For the same reasons, the Commission declines to propose to amend the Rule to reflect the American Optometric Association’s proposal ‘‘to ban sellers from marketing to specific customers to reorder their lenses after the prescription has expired (more than one year after the issue date or when the customer originally ordered lenses from the seller) unless the seller has specific knowledge the customer’s prescription is valid for more than one year.’’ 279 To the extent a patient does not have a valid prescription, the Rule already prohibits the sale of contact lenses. However, nothing in the Act supports the extension of this prohibition to the marketing (as opposed to the sale) of contact lenses. It may be in the patient’s best interest to receive a reminder to reorder lenses. If the patient does not have a valid prescription, the seller is prohibited from selling the lenses. However, if the patient has visited a prescriber in the interim, the patient will have a valid prescription and the sale can be made. 3. Quantities of Contact Lenses Obtained by Patients Many commenters expressed the concern that because of inadequacies in the Rule or lack of enforcement, consumers are able to obtain more than a year’s supply of contact lenses.280 For example, some commenters asserted that this occurs because some contact lens retailers allow patients to purchase 278 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) (Testimony of Howard Beales, Federal Trade Commission) (noting that passive verification is ‘‘in many respects self-enforcing’’). 279 American Optometric Association (Comment #644). 280 See, e.g., Rohleder (Comment #57) (‘‘Because of lack of enforcement, patients are able to purchase more contact lenses than they can use in a year, thus allowing them to circumvent seeing their doctor almost indefinitely.’’); Filandro (Comment #129) (‘‘A patient can order ten years’ worth of contacts and can’t be stopped by the law. A patient can order one years’ [sic] worth of contacts from ten different vendors and can’t be stopped by the law.’’); Stewart (Comment #136) (‘‘Patients are able to purchase multi-years [sic] worth of contact lenses even though the prescription clearly states expires in one year.’’); Tjandera (Comment #502) (noting that the Rule can be evaded because patients can order from multiple online retailers before the prescription expires). E:\FR\FM\07DEP2.SGM 07DEP2 88548 Federal Register / Vol. 81, No. 235 / Wednesday, December 7, 2016 / Proposed Rules asabaliauskas on DSK3SPTVN1PROD with PROPOSALS more than a year’s supply of contact lenses,281 while other prescribers reported that patients are able to refill their contact lenses prescription and obtain more lenses just prior to the prescription expiring.282 Prescribers also were concerned that they were receiving verification requests from sellers for contact lenses just as the patient’s prescription was expiring.283 A number of commenters complained that contact lens sellers are actively encouraging patients to refill their prescriptions right before they expire.284 For example, one commenter reported that sellers ‘‘send reminders to patients about a month before their contact lens prescription is expired, to buy another whole year’s prescription.’’ 285 One contact lens manufacturer reported that an online survey that it had commissioned showed that 58% of the online consumers that were surveyed indicated that they had received an email or letter from their retailer reminding them that their prescription was expiring soon and that the majority of these consumers had ordered more lenses as a result.286 Other commenters noted that patients are able to obtain 281 Young (Comment #91); Anklin (Comment #107); American Optometric Association (Comment #644). 282 Day (Comment #4); Driesen (Comment #47); Schwartz (Comment #80); Magee (Comment #95); Johnson (Comment #109); Rosemore (Comment #468); Garcia (Comment #511). See also Milsky (Comment #559) (‘‘Another common concern among prescribers is, for example, a prescription for a year’s supply of contact lenses getting filled one month before it expires, eleven months after the exam and fitting.’’). 283 Shin (Comment #70); Young (Comment #91); Chakuroff (Comment #189); Koury (Comment #573). 284 Mathai (Comment #33) (‘‘1800 contacts and other retailers prompt their customers to purchase an annual supply right before their prescription expires so they can save a trip to their Dr [sic] office.’’); Jones (Comment #83) (‘‘Contact lens suppliers are actively targeting patients to get them to order outside the limits of the prescription and/ or fishing for patient information.’’); Young (Comment #91) (‘‘Some online retailers are actively marketing to consumers to purchase more contact lenses when their prescription is ‘about to expire’.’’); Nelson (Comment #130) (‘‘1–800 Contacts also will not respect a number of refills on the Rx. Instead, they will email the patient before their Rx expires and tell them to order more. Patients then order another year of contacts and then cancel their yearly examination.’’); Hans (Comment #168) (patients prompted to save trip to doctor’s office); Ellenberger (Comment #272) (same); Gandy (Comment #530) (stop sellers from aggressive and unethical practice of encouraging patients to buy another years’ supply of lenses right before their prescription expires); Tass (Comment #586) (same). 285 Combs (Comment #90). 286 Johnson & Johnson Vision Care, Inc. (Comment #582) (‘‘nearly six-in-ten online consumers say they have received an email or letter from their retailer reminding them their Rx was expiring soon (58%) and the vast majority who received this notice (86%) ordered more contacts as a result’’). VerDate Sep<11>2014 20:36 Dec 06, 2016 Jkt 241001 more than a year’s supply of contact lenses by ordering from multiple sources.287 As explained by other commenters, if patients can obtain lenses in excess of a year’s supply, expiration dates on prescriptions become meaningless 288 and patients do not return to their eye care professional on an annual basis.289 Some prescribers provided anecdotal reports of patients not returning for an annual eye exam, sometimes for several years, because they had been able to purchase contact lenses online.290 To address these concerns, a number of commenters—optometric and ophthalmologic associations, individual prescribers, and contact lens manufacturers—proposed that the Commission amend the Rule to require contact lens prescriptions to include a maximum quantity of lenses that consumers can purchase prior to the prescription’s expiration.291 These 287 Jones (Comment #83); Filandro (Comment #129); Heuer (Comment #467); Endry (Comment #552); Milsky (Comment #559). 288 Mirkin (Comment #111); Endry (Comment #552). See also Harris (Comment #490) (purchasing contacts right before the prescription expires defeats the purpose of annual expiration dates and the monitoring of patient eye health). 289 See, e.g., Rohleder (Comment #57); Buthod (Comment #81); Moody (Comment #92); Anklin (Comment #107); Nett (Comment #449); Lisenby (Comment #662). 290 See, e.g., Weissman (Comment #50) (five years); Grace (Comment #64) (several years); Buthod (Comment #81) (3–5 years); Patel (Comment #188) (companies filling prescriptions for 10 years without successful verification); Pentecost (Comment #268); Silani (Comment #270) (returning for an exam ‘‘years’’ later); Chea (Comment #352); Arthur (Comment #371) (five years); Hornberger (Comment #457) (as many as five years); Pickering (Comment #475) (four to five years); Born (Comment #570) (many years); Gronquist (Comment #630) (years). 291 American Optometric Association (Comment #644); American Academy of Optometry (Comment #623); Virginia Optometric Association (Comment #16); Wisconsin Optometric Association (Comment #30); Utah Optometric Association (Comment #39); Pennsylvania Optometric Association (Comment #46); Alabama Optometric Association (Comment #48); Iowa Optometric Association (Comment #79); Michigan Optometric Association (Comment #86); California Optometric Association (Comment #119); New Mexico Optometric Association (Comment #211); Mississippi Optometric Association (Comment #548); Ohio Optometric Association (Comment #556); Connecticut Association of Optometrists (Comment #560); North Carolina State Optometric Society (Comment #567); Tennessee Association of Optometric Physicians (Comment #575); Colorado Optometric Association (Comment #584); New Jersey Society of Optometric Physicians (Comment #595); Coalition for Patient Vision Care Safety (Comment #621); Stahl (Comment #19); Lum (Comment #21); Peterson (Comment #22); Maanum (Comment #23); Matthews (Comment #25); Borsky (Comment #26); Chriqui (Comment #31); Hodes (Comment #42); Dodge (Comment #44); Kapoor (Comment #58); Comer (Comment #221); Leach (Comment #257); Chang (Comment #258); Whang (Comment #355); Knight (Comment #360); Senator Perdue (Comment #569); Reed (Comment #579); Johnson & Johnson Vision Care, Inc. (Comment PO 00000 Frm 00024 Fmt 4701 Sfmt 4702 commenters asserted that including a quantity limit on prescriptions would be beneficial to patients’ health and safety.292 One contact lens manufacturer stated that quantity limits ‘‘impose important safeguards and also strengthen the prescriber-patient relationship,’’ arguing that if a patient runs out of contact lenses, this would ‘‘offer[] yet another opportunity for consumers to ask questions, share health and other issues they may be encountering with their lenses, or adjust their prescription under the supervision of an eye care professional.’’ 293 In addition to including the maximum quantity on the prescription itself, several state optometric associations also recommended that the Commission ‘‘limit the number of contact lens boxes that can be purchased from a retailer at one time.’’ 294 Similarly, the Coalition for Patient Vision Care Safety proposed that the Commission ‘‘forbid retailers to sell in a single transaction a quantity of contact lenses that exceeds a single year’s supply.’’ 295 As an alternative, the Coalition suggested the Commission require that sellers only provide a supply equal to the length of the underlying prescription.296 A few commenters stated that because passive verification might allow the consumer to obtain more lenses than medically prescribed, quantity limits should be considered.297 A number of commenters argued that contact lens prescriptions should be #582); Leung (Comment #607); Wu (Comment #608); Vidulich (Comment #612); Lai (Comment #620); Pechko (Comment #628); Liu (Comment #656); Louie (Comment #657); Fong (Comment #669); Vo (Comment #673). 292 See, e.g., American Optometric Association (Comment #644). 293 Johnson & Johnson Vision Care, Inc. (Comment #582). 294 Virginia Optometric Association (Comment #16); Wisconsin Optometric Association (Comment #30); Utah Optometric Association (Comment #39); Pennsylvania Optometric Association (Comment #46); Alabama Optometric Association (Comment #48); Iowa Optometric Association (Comment #79); Michigan Optometric Association (Comment #86); California Optometric Association (Comment #119); New Mexico Optometric Association (Comment #211); Mississippi Optometric Association (Comment #548); Ohio Optometric Association (Comment #556); Connecticut Association of Optometrists (Comment #560); North Carolina State Optometric Society (Comment #567); Tennessee Association of Optometric Physicians (Comment #575); Colorado Optometric Association (Comment #584); New Jersey Society of Optometric Physicians (Comment #595). 295 Comment #621. 296 Id. See also Dierks (Comment #32); Ellingson (Comment #66); Moody (Comment #92); Bhadra (Comment #105); Rana (Comment #139); Patel (Comment #237); Santry (Comment #529). 297 Wilson (Comment #76) (passive verification allows the contact lens seller to sell the patients more lenses than are medically prescribed); Kline (Comment #161) (same); Johnson & Johnson Vision Care, Inc. (Comment #582). E:\FR\FM\07DEP2.SGM 07DEP2 Federal Register / Vol. 81, No. 235 / Wednesday, December 7, 2016 / Proposed Rules asabaliauskas on DSK3SPTVN1PROD with PROPOSALS treated the same way as pharmaceutical prescriptions in order to prevent the dispensing of excess quantities.298 As described by one commenter, this would require the quantity to be included on the prescription and the retention of the prescription by the dispenser filling it.299 A few commenters suggested a pro rata approach. For example, one prescriber recommended that consumers should only be able to obtain refills commensurate with the amount of time left on the prescription.300 Likewise, the Coalition for Patient Vision Safety proposed a similar approach, suggesting that the Commission ‘‘restrict the sale of contact lenses on a prescription that is nine months after issuance or older to up to 25 percent of the prescription’s course.’’ 301 One contact lens manufacturer recommended that the Commission modify the Rule to ‘‘place[] reasonable limits on the quantity of contact lenses a patient can purchase under a prescription (especially within a few months of a prescription expiring)’’ in order to encourage patients to go to their eye care professional for routine examinations.302 However, other commenters disagreed with the proposal to include quantity limits on contact lens prescriptions. 1– 800 CONTACTS argued that imposing quantity limits would ‘‘inconvenience consumers and lead to unhealthy practices, such as wearing lenses longer than recommended.’’ 303 This commenter asserted that patients could misplace or tear lenses, or might replace their lenses more frequently than anticipated by their prescription, and consequently concluded that ‘‘there are any number of very legitimate reasons a consumer may want to purchase what appear to be (based on simple multiplication) extra lenses and there is no valid reason to restrict that consumer’s options.’’ 304 Another contact lens retailer claimed that prescribers were circumventing the minimum one-year expiration period by 298 See, e.g., Filandro (Comment #129); Kalman (Comment #150); Bainbridge (Comment #152); Anderson (Comment #185); Palermo (Comment #212); Sanders (Comment #235); Sanders (Comment #236); Smith (Comment #319); Chesen (Comment #350); Perichak (Comment #415); Witmeyer (Comment #418); Palmer (Comment #484); Pierzchala (Comment #500); Haefs (Comment #525); Johnson & Johnson Vision Care, Inc. (Comment #582); Tass (Comment #586); Ball (Comment #590); Alexander (Comment #666). 299 Kalman (Comment #150). 300 See, e.g., Milsky (Comment #559). 301 Comment #621. 302 CooperVision, Inc. (Comment #591). 303 Comment #568. 304 Id. VerDate Sep<11>2014 20:36 Dec 06, 2016 Jkt 241001 ‘‘limit[ing] the quantity of replacement lenses, despite the lack of any medical reason for ever doing so’’ and that ‘‘a consumer’s need for additional lenses could arise for a number of reasons.’’ 305 This commenter proposed that the Commission amend Section 315.6 of the Rule to include a provision stating that a ‘‘contact lens prescription shall be valid for an unlimited quantity of lenses regardless of any prescriber-imposed limitation to the contrary.’’ 306 After reviewing the comments, the Commission has determined not to propose to amend the Rule to adopt any of the contact lens quantity proposals put forth by commenters. First, the Commission does not believe that there is sufficient evidence in the rulemaking record to support amending the Rule to impose the quantity limit proposals suggested by commenters. Although some commenters conducted and submitted data from online surveys for the proposition that consumers are purchasing contact lenses as their prescriptions are about to expire, this data does not show the quantity of lenses that consumers are actually purchasing. For example, even if one were to assume that the APCO online survey results were completely reliable, the survey only asked consumers whether they purchased lenses at certain points in time; it did not assess the quantity of lenses that consumers actually purchased. The fact that a consumer purchased some contact lenses just prior to a prescription expiring does not necessarily mean that the consumer has purchased an excessive amount of contact lenses, nor does it support the contention that consumers are no longer getting eye examinations. Instead, consumers could be purchasing small amounts of lenses to last until their next scheduled eye examination. When the Commission examined the contact lens industry in 2005, it found that consumers do not typically purchase a full year’s supply at one time.307 The Commission has not seen any evidence indicating that this has changed. Although commenters to the current Rule review provided various anecdotal and hypothetical accounts of consumers buying excessive quantities of lenses, they did not provide empirical evidence regarding the amount of lenses consumers are obtaining, nor did they submit evidence to show that consumers are not visiting 305 LD Vision Group (Comment #544). 306 Id. 307 2005 Contact Lens Report, supra note 14, at 6 note 18 (citing two studies that found that just 12– 20% of consumers purchase a year’s supply at a time). PO 00000 Frm 00025 Fmt 4701 Sfmt 4702 88549 their eye care practitioners as frequently.308 Second, regardless of the evidence, or lack thereof, in the record to support the quantity limit proposals, the Commission believes that it would be difficult to administer the proposed limits, and that rather than increasing patient eye health and safety, such proposals could have the opposite effect. For example, if a consumer is running out of contact lenses and does not have time to see a prescriber promptly, there is a significant chance that the consumer will not adhere to the recommended contact lens replacement schedule and will instead try to ‘‘stretch out’’ their lenses by re-wearing them until they can visit a prescriber. The failure to replace lenses is a welldocumented cause of many contactlens-related health issues.309 Absent empirical evidence that a substantial number of consumers are obtaining excessive amounts of contact lenses, or are not returning to their prescribers for eye examinations, the Commission believes that the risk of not replacing lenses outweighs the harm of consumers obtaining more lenses than strictly anticipated by the length of a contact lens prescription. Nevertheless, the Commission is concerned about anecdotal reports that sellers are contacting patients and encouraging them to stockpile contact lenses prior to the expiration of their prescriptions in order to avoid visiting their eye care professionals. The Commission cautions sellers that such practices run counter to the spirit of the Act, and the Commission will look closely at these alleged practices. The Commission also declines to propose that the Rule be amended to provide that a ‘‘contact lens prescription shall be valid for an unlimited quantity of lenses regardless of any prescriberimposed limitation to the contrary.’’ 310 The commenter suggesting this amendment produced no evidence supporting the allegation that prescribers are using quantity limits to undercut the length of a prescription. The Commission also notes that, as recognized during the initial rulemaking, some State laws or regulations may require prescribers to include quantity information on the prescription and some prescribers in other States without such requirements 308 Indeed, the Coalition for Patient Vision Care Safety indicated that ‘‘87 percent of contact lens patients had an eye exam last year.’’ Comment #621. 309 Cope, supra note 29, at 867 (‘‘contact lens wearers who do not follow recommended contact lens replacement schedules have more complications and eye discomfort’’). 310 LD Vision Group (Comment #544). E:\FR\FM\07DEP2.SGM 07DEP2 88550 Federal Register / Vol. 81, No. 235 / Wednesday, December 7, 2016 / Proposed Rules asabaliauskas on DSK3SPTVN1PROD with PROPOSALS may choose to include such information on the prescription. At this time, the Commission reiterates that such prescribers must not use quantity limits to frustrate the prescription expiration requirements of Section 315.6, and that the quantity specified in the prescription must be sufficient to last through the prescription’s expiration date.311 Finally, the Commission also believes that the Rule, as currently drafted, is sufficient to address the quantity limit concerns posited by commenters. During the initial rulemaking, the Commission examined the issue of requiring quantity limits on prescriptions.312 At that time, the Commission concluded that it was not necessary to include the quantity of lenses on the prescription to limit patients’ ability to circumvent the expiration date because the verification process would allow prescribers to prevent patients from ordering excessive contact lenses.313 In this rule review, commenters raised concerns that the verification process was not an adequate safety net because the ‘‘verification process is not triggered when a patient provides a contact lens retailer with a complete copy of prescription’’ and the verification process is bypassed.314 Accordingly, it is possible that consumers could use a copy of a prescription to shop at multiple retailers, or engage in other practices, in order to obtain excessive amounts of contact lenses.315 Although it is possible that these practices could occur, there is no empirical evidence in the record to show the frequency or extent of such practices.316 311 69 FR at 40488. If the prescription specifies a lesser quantity of lenses or refills, the prescriber must have a legitimate medical reason for doing so, and the requirements imposed by Section 315.6(b) on writing a prescription for less than one year must be met. Id. 312 In reaching that determination, the Commission first noted that the Act did not require the inclusion of quantity information on the prescription. The Commission then discussed its concern that if quantity information was included, prescribers might use those quantity limits to impose prescription expiration dates that are effectively shorter than the one-year period imposed under the Act. 69 FR at 40488. 313 69 FR at 40488 (explaining that Section 315.5(b) requires verification requests to contain the quantity of lenses ordered, and that the quantity ordered may be a legitimate basis for a prescriber to treat a request for verification of a prescription as ‘‘inaccurate’’). 314 American Optometric Association (Comment #644). See also Coalition for Patient Vision Care Safety (Comment #621). 315 Id. 316 For the same reasons, the Commission also declines to propose to amend the Rule per the American Optometric Association’s proposal that the Commission limit the quantity of contact lens boxes that retailers advertise as being able to be VerDate Sep<11>2014 20:36 Dec 06, 2016 Jkt 241001 Other commenters encouraged the Commission to increase enforcement efforts to prevent consumers from obtaining more contact lenses than anticipated by the length of the prescription.317 As already noted, if the Commission receives evidence that sellers are dispensing contact lenses in violation of the Rule, the Commission will investigate such allegations, as appropriate. B. Private Label Lenses and Contact Lens Substitution 1. Private Label Lenses A few sellers commented on the Rule provision regarding private label lenses.318 Section 315.2 of the Rule defines private label contact 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.’’ 319 A prescription for private label contact lenses, in addition to other required information, must include the name of the manufacturer, trade name of the private label brand, and if applicable, trade name of equivalent brand name.320 The Rule’s requirements for private label lens prescriptions track the language of the Act.321 Although most contact lenses are sold under their national brand name, some manufacturers also distribute their lenses to prescribers and retailers under private labels. Sometimes the private label is unique to that seller and other times the private label brand may be available at multiple outlets.322 LD Vision Group, an online contact lens retailer, asserted that manufacturers and prescribers design anticompetitive strategies involving private label lenses to ‘‘thwart consumer freedom.’’ 323 Specifically, the company contended purchased at one time. Comment #644. In its comment, the American Optometric Association contended that it is possible that consumers could purchase large amounts of contact lenses from some online retailers; however, it did not provide support for this contention. 317 See, e.g., Day (Comment #4); Mathai (Comment #33); Nelson (Comment #130); Hans (Comment #168); Garcia (Comment #511); Gandy (Comment #530); Tass (Comment #586). 318 LD Vision Group (Comment #544); 1–800 CONTACTS (Comment #568). 319 16 CFR 315.2. 320 Id. 321 See 15 U.S.C. 7610(3). 322 2005 Contact Lens Report, supra note 14, at 14–15. 323 Comment #544. LD Vision Group explained that manufacturers acquiesce to prescribers because it is the prescribers who select their patients’ contact lenses. Id.; see also 1–800 CONTACTS (Comment #568) (commenting on manufacturers’ strong incentives to cater to the interests of prescribers rather than consumers because prescribers determine the brand and modality of their patients’ lenses). PO 00000 Frm 00026 Fmt 4701 Sfmt 4702 that to keep consumers from purchasing contacts elsewhere, some prescribers ‘‘will provide unpopular or private-label lenses without published equivalents or for which the equivalents are confusing.’’ 324 For instance, the company stated that one private label ‘‘is purportedly available with an 8.3 or 8.6 base curve, while the brand name lens—though it is the exact same lens— is purportedly available with an 8.4 or 8.7 base curve.’’ 325 Another manufacturer, according to LD Vision Group, ‘‘offers four different lenses under a private label: Standard, plus, premium, and premium plus, but the national-label equivalents do not use the same identifiers.’’ 326 Although prescribers are required by the Rule to list equivalent information on the prescription, LD Vision Group asserted that prescribers do not always comply, and absent manufacturers’ identification of equivalent lenses, ‘‘the retailer must either refuse to dispense unknown equivalents or make assumptions based on intentionally misleading privatelabel designations and risk dispensing the wrong lenses to the potential detriment of their customers’ eye health.’’ 327 LD Vision Group did not quantify the extent of this problem, or provide empirical evidence as to its scope.328 In order to remedy the aforementioned issues, LD Vision Group proposed that the Commission amend the Rule to require prescribers to annotate a private label lens prescription with the brand-name equivalent and, if a name-brand equivalent is unavailable, the private label prescription must be medically necessary for that particular patient. It also recommended requiring manufacturers of contact lenses to disclose brand equivalency information on private label and brand-label packaging, or otherwise make it available to sellers.329 The Commission declines to propose to modify the Rule to implement these recommendations. Although the Act expressly requires that, in the case of private label contact lens prescriptions, prescribers include ‘‘trade name of equivalent brand name,’’ the Act does 324 Comment #544. Vision Group did not identify the private label or manufacturer engaged in this practice. Comment #544. 326 Id. 327 As discussed in Section V.B.2, infra, when sellers substitute lenses that are not identical to the prescribed contact lenses, they violate the Rule. 328 The Commission understands that sales of private label lenses comprise a small part of the market, and most major manufacturers do not sell private label lenses. 329 LD Vision Group (Comment #544). 325 LD E:\FR\FM\07DEP2.SGM 07DEP2 Federal Register / Vol. 81, No. 235 / Wednesday, December 7, 2016 / Proposed Rules 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.330 Nor does the Act expressly contemplate the imposition of disclosure requirements on manufacturers. However, nothing in the Act or Rule prohibits manufacturers from making brand equivalency disclosures on their packaging, or otherwise making such information available to sellers. The Commission understands that some, if not all, manufacturers who offer private labels already make this information readily available to retailers. Additionally, the Commission notes that it is a violation of the Rule for prescribers to fail to comply with their obligation to specify a brand equivalent, should one exist, when writing a prescription. The Commission encourages sellers and consumers to submit evidence of any such violations to the agency for possible enforcement action. 2. Alteration of Contact Lens Prescriptions by Sellers asabaliauskas on DSK3SPTVN1PROD with PROPOSALS Section 315.5(e) of the Rule prohibits sellers from altering a contact lens prescription.331 Notwithstanding this prohibition, 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.’’ 332 The language of this Rule provision is substantively the same as the language of the Act, with one exception discussed below.333 The Commission received a number of comments, primarily from prescribers, that complained that online contact lens sellers are selling patients lenses different from those they prescribed.334 Prescribers expressed 330 In the initial rulemaking, sellers made a recommendation to open up the market by requiring prescribers, when prescribing private label contact lenses, to identify on the prescription the name of a brand that a consumer could purchase from a retailer other than the prescribing office. 69 FR at 40503. The Act does not limit, in any way, the brand that a prescriber must select and thus, the Commission concluded that such a requirement would go beyond the Act. Id. LD Vision Group’s similar proposal to limit prescribers from prescribing private label brands without a brand-equivalent, except in the case of medical necessity, fails for the same reason. 331 16 CFR 315.5(e). 332 Id. 333 See 15 U.S.C. 7603(f). 334 See, e.g., Kapoor (Comment #58); Narayan (Comment #60); Thomas (Comment #61); Weinberg (Comment #87); Anderson (Comment #96); Hopkins (Comment #102); Johnson (Comment #109); O’Brien (Comment #127); Stewart (Comment #136); Hans (Comment #168); Hamilton (Comment #216); Gibson (Comment #217); Cassis (Comment #233); Chesen (Comment #321); Silver (Comment #349); McWilliams (Comment #362); Wittmann (Comment VerDate Sep<11>2014 20:36 Dec 06, 2016 Jkt 241001 concern that contact lenses are being treated like commodities, rather than restricted medical devices regulated by the FDA.335 These commenters contended that contact lenses, even those with similar refractive specifications, are not interchangeable.336 One commenter, a manufacturer, opined that ‘‘each brand is unique and proprietary to each manufacturer and designed to suit a different set of corresponding patient physiology and consumer needs.’’ 337 Several prescribers and a manufacturer also explained that prescribers work with patients to fit them with the most compatible, safe, and effective contact lens and that each patient’s eyes react differently to individual brands.338 According to these commenters, when a patient receives a contact lens that is not identical to the one prescribed, those lenses have not been fit on the patient, may not be appropriate, and can even be harmful for the patient.339 Specifically, prescribers stated that scarring, infection, allergic reactions, corneal ulcers, impaired or even lost vision can result or have resulted from patients wearing lenses that were not #421); Nett (Comment #449); Eggers (Comment #473); Kegarise (Comment #477); Kosunick (Comment #501); Wren (Comment #520); Lai (Comment #541); Hamada (Comment #603); Coalition for Patient Vision Care Safety (Comment #621); Maceyko (Comment #642); American Optometric Association (Comment #644). 335 Kelly (Comment #78); Callihan (Comment #187); Sancho (Comment #226); West (Comment #230); Nett (Comment #449); Vu (Comment #561); Reed (Comment #579). Cf. LD Vision Group (Comment #544) (calling lenses a ‘‘disposable commodity’’). 336 See, e.g., Johnson & Johnson Vision Care, Inc. (Comment #582) (citing studies supporting this statement). A number of commenters similarly explained that because each contact lens fits the eye differently, there is no such thing as a generic contact lens. See, e.g., Jones (Comment #63); Miyamura (Comment #77); Jones (Comment #83); Easton (Comment #432). 337 Comment #582. Johnson & Johnson Vision Care, Inc. described several parameters that make a contact lens brand unique, including oxygen transmissibility, water content, iconicity, rigidity or modulus, silicone and fluorine content, lipid deposition, wettability/wetting agent, thickness, diameter, base curve, edge design, surface characteristics/treatments, modality, UV blocking, and interaction with care solutions. Other commenters mentioned modality (daily, two week replacement, or monthly), optical clarity, lifestyle, medical conditions, and current medications as factors influencing the prescriber’s selection of the contact lens to prescribe. Morgan (Comment #144); Assell (Comment #397). 338 See Sasner (Comment #182); Williams (Comment #261); Steinleitner (Comment #517); Nielson (Comment #565) (prescriber questioning why he learned how to fit contact lenses if patients can get any lens they want without his input); Johnson & Johnson Vision Care, Inc. (Comment #582). 339 Id. PO 00000 Frm 00027 Fmt 4701 Sfmt 4702 88551 prescribed.340 A few prescribers described patients who, after wearing lenses that had not been prescribed for them, could no longer wear contact lenses or whose vision could no longer be fully corrected.341 As to the source of the alteration problem, commenters pointed to both online sellers as well as patients. Commenters, almost exclusively prescribers, asserted that sellers want to maximize their profits and may have little to no consideration for their customers’ eye health,342 and that patients switch brands to obtain cheaper lenses or seek brands they have seen in commercials.343 Some prescribers also stated or implied that these substitutions occur as a result of the passive verification system, and encouraged the Commission to adopt an active verification system.344 It is unclear how frequently illegal substitutions are occurring, or how many sellers are engaged in this activity. In its comment, Johnson & Johnson Vision Care, Inc. cited to a 2015 online survey conducted on its behalf that found that ‘‘one-in-four online consumers report having received a different brand of contact lenses than they had ordered without being given advanced warning they were getting another brand.’’ 345 Even assuming the survey methodology is sound and the stated conclusion of the survey is accurate, it is not clear whether the positive responses reflect instances 340 Williford (Comment #38); Kapoor (Comment #58); Jones (Comment #63); Morgan (Comment #144); Herve (Comment #148); Sausner (Comment #182); McWilliams (Comment #362); Elmore (Comment #396); Wittmann (Comment #421); Kegarise (Comment #447); Sirotkin (Comment #464); Abbott (Comment #497); Wren (Comment #520); Evans (Comment #523); Hamada (Comment #603); Capps (Comment #610); Coalition for Patient Vision Care Safety (Comment #621); Vehab (Comment #622); Mortenson (Comment #636); Maceyko (Comment #642). 341 Schram (Comment #184); McWilliams (Comment #362). 342 Nguyen (Comment #82); Eggers (Comment #473); Lupinski (Comment #499); Nielsen (Comment #565). Other prescribers are concerned that they will be liable or at risk of losing their licenses if the substitution causes the consumer harm. See, e.g., Carroll (Comment #5); Thomas (Comment #61). 343 LaDouceur (Comment #178); Schram (Comment #184); Marler (Comment #504); Vehab (Comment #622). 344 Prescribers contend that after sellers convince patients to order different lenses than those prescribed, or patients give sellers the name of a lens not identical to the prescribed lens, the sellers send a verification request containing the nonprescribed lenses, and those requests are sometimes passively verified. Eggers (Comment #473); Wren (Comment #520). As previously explained, see supra Section IV.C.1, the Commission lacks authority to eliminate the passive verification system. 345 Comment #582. E:\FR\FM\07DEP2.SGM 07DEP2 88552 Federal Register / Vol. 81, No. 235 / Wednesday, December 7, 2016 / Proposed Rules asabaliauskas on DSK3SPTVN1PROD with PROPOSALS when sellers made illegal alterations or, alternatively, instances when consumers ordered a brand other than the prescribed brand and the prescribers then corrected the prescriptions. Nor is it clear whether positive responses include instances where eye care professionals prescribed private label lenses and sellers appropriately substituted them with identical lenses, made by the same manufacturer and sold under a different label, as expressly permitted by Section 315.5(e). Because one cannot tell the percentage that was the result of unauthorized alterations, the survey data is not conclusive.346 The Commission notes that unauthorized alterations violate the Rule as currently written, and thus there is no need to amend the Rule to address this issue.347 In some cases, patients may request to purchase a brand of lenses not identical to the one prescribed. In those instances, the seller may include the wrong brand in the verification request. If any of the information required by Section 315.5(b)(2) to be included in the verification request is incorrect, prescribers are encouraged to provide the correct information to the seller. Several commenters requested that the Commission better enforce the Rule against sellers that engage in illegal substitutions.348 If the Commission receives evidence that sellers are engaged in illegal substitutions, the Commission will investigate the allegations, as appropriate.349 346 Other seemingly relevant survey questions, one of which a commenter cited to, may be similarly flawed. For example, the Coalition for Patient Vision Care Safety pointed out that 31% of respondents answered positively when asked: ‘‘When buying contact lenses online or over the phone in the past, has the company you were ordering from ever informed you that they do not carry or do not currently have stocked, the brand of contact lenses on your prescription, and advised you to get another brand of contact lenses instead?’’ Comment #621. In response to a subsequent survey question, 80% of those respondents indicated that they ‘‘then order[ed] that other brand of contact lenses.’’ The Commission notes that positive responses to these questions do not necessarily reflect a violation of the Rule. For example, a prescriber changing a prescription to a different lens in the interim would thereby render the sale proper. 347 Because prescription alteration violates the Rule, the Commission need not make its own assessment of Johnson & Johnson Vision Care, Inc.’s and numerous prescribers’ statements concerning the non-interchangeability of lenses and the resulting eye health risks. 348 Thomas (Comment #61); Lai (Comment #541); Johnson & Johnson Vision Care, Inc. (Comment #582). 349 The Commission notes that the prescriber has the ability to block an illegal substitution by actively responding to a verification request for a non-prescribed lens and indicating its invalidity. In fact, in circumstances where a consumer selects a non-prescribed brand, the prescriber is likely the only one who can ‘‘catch’’ the error. VerDate Sep<11>2014 20:36 Dec 06, 2016 Jkt 241001 Lastly, one commenter, an optometrist, recommended that a retailer should be required to warn or educate patients about the potential consequences of changing brands or other parameters without a doctor’s authorization through a ‘‘statement of education’’ with every order, warning patients that ‘‘contact lenses are a medical device and the wearing of or changing of a brand or prescription without a doctor’s authorization is illegal and could result in damage, even blindness to the recipient.’’ 350 The Commission declines to modify the Rule in such a fashion. Although the Commission does not take issue with the importance of educating patients about the need to consult their prescriber before switching contact lens brands, and encourages sellers, prescribers, and manufacturers to do so, we have no evidence that the benefit of imposing such a requirement on sellers would outweigh the costs. Through discussions with industry members, it has come to the Commission’s attention that in addition to prescribers, some other sellers 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. The language of the Act clearly permits substitution in cases where the same contact lenses are manufactured by the same company and sold under multiple labels to individual providers.351 Although the Rule similarly permits a seller to substitute lenses that are identical to, and are made by the same manufacturer as, the one listed on the prescription,352 the language set forth in Section 315.5(e) of the Rule could be read to limit such substitution to instances where private label lenses are listed on the prescription and the seller wishes to substitute brand name lenses.353 The Commission recognizes that the current construction of Section 315.5(e) of the Rule does not conform to the language or intent of the Act. The clear language of the Act allows sellers to substitute private label lenses for brand name lenses when the substituted lenses are ‘‘manufactured by the same 350 Kegarise (Comment #447). U.S.C. 7603(f). 352 16 CFR 315.5(e). 353 Section 315.5(e) modifies ‘‘contact lenses’’ with the term ‘‘private label,’’ but the Act does not contain that modifier. Cf. 15 U.S.C. 7603(f). 351 15 PO 00000 Frm 00028 Fmt 4701 Sfmt 4702 company and sold under multiple labels to individual providers.’’ 354 To conform the Rule to the Act, the Commission proposes to strike the words ‘‘private label’’ from Section 315.5(e) and seeks comment on its proposal. The definitions in the Rule of a ‘‘contact lens prescription’’ and of a ‘‘private label contact lens’’ would remain unchanged. C. HIPAA Issues The Commission received a few comments that identified concerns with how the Rule’s verification framework interacts with the Health Insurance Portability and Accountability Act of 1996 355 (‘‘HIPAA’’) Privacy and Security Rules (‘‘HIPAA Rules’’).356 One prescriber expressed the opinion that the Contact Lens Rule’s verification system was in direct conflict with HIPAA and detailed his attempts to procure HIPAA authorizations from his patients prior to releasing the prescription to a third-party seller.357 Another commenter recommended that HIPAA should apply to the verification process and that any verification request should be accompanied by an authorization signed by the patient.358 A third commenter expressed concern that automated telephonic verification requests were in direct violation of HIPAA because the patient’s personal information was relayed to the person answering the telephone, without any mechanism to ensure that it was the intended recipient.359 A few prescribers also complained that sellers’ practices of trying to obtain prescriptions without patient authorization violated HIPAA.360 Other commenters stated that some prescribers were not complying with the Contact Lens Rule and were using HIPAA to avoid doing so. One seller complained that ‘‘[s]ome prescribers will still refuse to verify even with the law in place, stating (incorrectly) that HIPAA or a state privacy rule prohibits 354 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 as long as the lenses are identical. 355 Public Law 104–191 (Aug. 21, 1996). 356 45 CFR parts 160, 164. 357 Ciszek (Comment #134). 358 Pao (Comment #181). 359 Stuart (Comment #635) (consumers’ ‘‘personal and medical information is currently being transmitted unsecured to a third party by using an automated phone verification system’’). 360 St. Martin (Comment #292) (‘‘their phishing for prescriptions should be considered a HIPAA violation because often this is done without the patient’s permission’’). See also Vensand (Comment #59) (expressing concern about the acquisition and sale of patient information); Ciszek (Comment #134) (complaining that sellers are calling of their own accord, without the patient initiating the request). E:\FR\FM\07DEP2.SGM 07DEP2 Federal Register / Vol. 81, No. 235 / Wednesday, December 7, 2016 / Proposed Rules release of the prescription and that only the patient can ask for it.’’ 361 Likewise, the National Association of Optometrists and Opticians noted that it was ‘‘aware of instances where prescribers incorrectly inform patients that HIPAA or other laws require a written authorization from the patient or face-to-face requests by the patient to the prescriber.’’ 362 This commenter recommended that the Commission make clear to prescribers, sellers, and consumers that HIPAA does not prevent compliance with the Rule’s verification process and that to claim otherwise is an unfair and deceptive practice.363 The Commission reiterates that the HIPAA Privacy Rule does not restrict prescribers’ ability to provide or verify contact lens prescriptions under the Rule.364 As a preliminary matter, HIPAA does not require submission of a HIPAA authorization for the prescriber to release a contact lens prescription to a patient.365 Furthermore, as the Commission explained in the initial rulemaking, the HIPAA Privacy Rule permits a HIPAA covered entity, such as a covered prescriber, to disclose protected health information (‘‘PHI’’) without patient authorization for ‘‘treatment’’ purposes or when ‘‘required by law,’’ as well as for other specified purposes.366 Providing, confirming, or correcting a prescription for contact lenses for a contact lens seller as contemplated under the Contact Lens Rule constitutes ‘‘treatment’’ under the HIPAA Privacy Rule.367 In addition, to the extent the asabaliauskas on DSK3SPTVN1PROD with PROPOSALS 361 LD Vision Group (Comment #544). 362 Comment #549. 363 Id. 364 69 FR at 40501. 365 See 45 CFR 164.502(a)(1); U.S. Dep’t of Health & Human Servs., Office for Civil Rights, ‘‘Summary of the HIPAA Privacy Rule’’ 4–5 (2003), http:// www.hhs.gov/sites/default/files/ privacysummary.pdf (‘‘A covered entity is permitted . . . to use and disclose protected health information, without an individual’s authorization, for the following purposes or situations: (1) To the Individual (unless required for access or accounting of disclosures); (2) Treatment, Payment, and Health Care Operations; (3) Opportunity to Agree or Object; (4) Incident to an otherwise permitted use and disclosure; (5) Public Interest and Benefit Activities; and (6) Limited Data Set for the purposes of research, public health or health care operations. Covered entities may rely on professional ethics and best judgments in deciding which of these permissive uses and disclosures to make.’’) (footnote omitted). 366 69 FR at 40501. 367 Id. See also Standards for Privacy of Individually Identifiable Health Information, 67 FR 53182, 53219 (Aug. 14, 2002). The U.S. Department of Health & Human Services has explained further that ‘‘disclosure of protected health information by an eye doctor to a distributor of contact lenses for the purpose of confirming a contact lens prescription is a treatment disclosure and is permitted under the Privacy Rule at 45 CFR 164.506.’’ See U.S. Dep’t Health & Human Servs., VerDate Sep<11>2014 20:36 Dec 06, 2016 Jkt 241001 disclosure of PHI to provide, confirm, or verify a contact lens prescription is required under the Act and the Rule, such disclosure constitutes a disclosure ‘‘required by law’’ under the HIPAA Privacy Rule.368 For these reasons, patient authorization is not required for a prescriber to provide or verify a contact lens prescription with the contact lens seller, or to provide a contact lens prescription to the patient.369 In addition to the comments submitted in this rule review, the Commission has received other questions and complaints related to prescribers’ HIPAA obligations under the Rule. For example, one prescriber asked whether HIPAA precluded his office from emailing a copy of a prescription to a patient without written authorization if the email communication was not encrypted. Correspondingly, some consumers have complained that their eye care practitioners have refused to email contact lens prescriptions to them. As a threshold matter, the Contact Lens Rule itself contemplates email communication, stating that the prescriber shall ‘‘provide or verify’’ the prescription ‘‘by electronic or other means.’’ 370 Further, the HIPAA Rules do not preclude covered prescribers from emailing contact lens prescriptions to patients or sellers. According to guidance provided by the U.S. Department of Health & Human Services, the HIPAA Rules allow health care providers to communicate electronically with patients, provided they apply reasonable safeguards.371 Although a covered provider must consider encryption to protect against unintentional disclosures, the provider may determine that it is not reasonable Health Information Privacy, FAQs, ‘‘Does the HIPAA Privacy Rule permit an eye doctor to confirm a contact prescription received by a mail order contact company?,’’ http://www.hhs.gov/ hipaa/for-professionals/faq/270/does-hipaa-permitan-eye-doctor-to-confirm-a-contract-prescriptionfrom-a-mail-order-company/index.html. 368 See 45 CFR 164.512(a). 369 In addition, the HIPAA Privacy Rule right of access requires a covered prescriber to provide to the patient upon request or to another person she designates a copy of a prescription. See 45 CFR 164.524(c)(3). See also U.S. Dep’t Health & Human Servs., Health Information Privacy, HIPAA Guidance, ‘‘Individuals’ Right under HIPAA to Access their Health Information,’’ http:// www.hhs.gov/hipaa/for-professionals/privacy/ guidance/access/. 370 16 CFR 315.3(a)(2). 371 U.S. Dep’t Health & Human Servs., Health Information Privacy, FAQs, ‘‘Does the HIPAA Privacy Rule permit health care providers to use email to discuss health issues and treatment with their patients?,’’ http://www.hhs.gov/hipaa/forprofessionals/faq/570/does-hipaa-permit-healthcare-providers-to-use-email-to-discuss-healthissues-with-patients/. See also 45 CFR 164.530(c). PO 00000 Frm 00029 Fmt 4701 Sfmt 4702 88553 and appropriate, and may instead apply precautions when transmitting unencrypted email, such as checking the email address for accuracy before sending, sending an email alert to the intended recipient for address confirmation prior to sending the message, and limiting the amount and type of PHI transmitted through the email.372 Regardless, where an individual requests that the covered entity transmit PHI by unencrypted email, as is their right under the HIPAA Privacy Rule right of access, a covered entity must do so.373 Before sending unencrypted email containing PHI to a patient, the entity should advise the patient of the risk that the unencrypted PHI could be intercepted and accessed by unauthorized third parties. If, after having been advised of the risks the patient still prefers to receive his or her PHI via unencrypted email, the patient has the right to receive the PHI in that manner and the covered entity is not responsible for unauthorized access to the PHI during electronic transmission, nor is the covered entity responsible for safeguarding the PHI once delivered to the patient.374 Conversely, a covered prescriber also must honor a patient’s reasonable request that the prescriber not send communications via unencrypted email, by offering other means, such as encrypted email, secure patient portal, postal mail, or telephone.375 D. Enforcement Efforts In addition to proposing amendments to specific Rule provisions to further the Rule’s goals of competition and patient welfare, several commenters also urged the Commission to increase its enforcement efforts and stressed the importance of enforcing the Rule to ensure that its benefits are realized and 372 Encryption of PHI must be implemented where a covered entity has determined that it is a reasonable and appropriate safeguard as part of its risk management. See U.S. Dep’t Health & Human Servs., Health Information Privacy, FAQs, ‘‘Is the use of encryption mandatory in the Security Rule?,’’ http://www.hhs.gov/hipaa/for-professionals/faq/ 2001/is-the-use-of-encryption-mandatory-in-thesecurity-rule/index.html. A covered health care provider also must protect PHI in those emails while they are stored on servers, workstations, mobile devices, and other computer systems, through encryption and other safeguards, as appropriate. See 45 CFR 164.306(a). 373 45 CFR 164.524(c). See also U.S. Dep’t Health & Human Servs., Health Information Privacy, FAQs, ‘‘Individuals’ Right under HIPAA to Access their Health Information 45 CFR 164.524,’’ http:// www.hhs.gov/hipaa/for-professionals/privacy/ guidance/access/. 374 78 FR 5634 (Jan. 25, 2013). 375 45 CFR 164.522(b). E:\FR\FM\07DEP2.SGM 07DEP2 88554 Federal Register / Vol. 81, No. 235 / Wednesday, December 7, 2016 / Proposed Rules its risks minimized.376 For example, several optometric associations urged the Commission to enforce the basic patient safeguards outlined in the Act to protect patients and reduce unnecessary costs.377 These commenters argued that the sale of contact lenses without a valid prescription increases risks for patients and ultimately leads to higher health costs, and called for the Commission to take action against retailers selling lenses without a valid prescription.378 The Coalition for Patient Vision Care Safety asserted that ‘‘noncompliance with and loopholes within the law have resulted in a deceptive flow of information to contact lens patients, and have the potential to compromise seriously the vision health of patients.’’ 379 Many individual prescribers also urged the Commission generally to increase enforcement of the Rule.380 On the other hand, online retailers such as 1–800 CONTACTS and Warby Parker recommended increased enforcement efforts against noncompliant prescribers, particularly with respect to the automatic release of prescriptions.381 These commenters complained that despite ‘‘the widespread refusal of prescribers to release prescriptions,’’ Commission 376 See, e.g., Barr (Comment #639). Optometric Association (Comment #644); Virginia Optometric Association (Comment #16); Wisconsin Optometric Association (Comment #30); Utah Optometric Association (Comment #39); Pennsylvania Optometric Association (Comment #46); Alabama Optometric Association (Comment #48); Iowa Optometric Association (Comment #79); Michigan Optometric Association (Comment #86); California Optometric Association (Comment #119); New Mexico Optometric Association (Comment #211); Mississippi Optometric Association (Comment #548); Ohio Optometric Association (Comment #556); Connecticut Association of Optometrists (Comment #560); North Carolina State Optometric Society (Comment #567); Tennessee Association of Optometric Physicians (Comment #575); Colorado Optometric Association (Comment #584); New Jersey Society of Optometric Physicians (Comment #595). See also American Academy of Ophthalmology (Comment #611) (‘‘Wearing improper lenses can further complicate existing vision issues, including leading to infection in the eye. The sale of lenses without a prescription is a practice that continues despite the Rule, and the Academy believes that the Commission should take swift action to improve enforcement of the Rule.’’). 378 Id. 379 Comment #621. 380 See, e.g., Filandro (Comment #129); Sandler (Comment #135); Jankowski (Comment #153); Hans (Comment #168); Nguyen (Comment #175); Robertson (Comment #180); Schumacher (Comment #193); Sisson (Comment #254); Frederick (Comment #269); Bolenbaker (Comment #357); Yamamoto (Comment #408); Palmer (Comment #484); Williams (Comment #494); Marler (Comment #504); Koop (Comment #506); Korth (Comment #516); Lai (Comment #541); Piersol (Comment #571). See also Senator Perdue (Comment #569). 381 1–800 CONTACTS (Comment #568); Warby Parker (Comment #593). asabaliauskas on DSK3SPTVN1PROD with PROPOSALS 377 American VerDate Sep<11>2014 20:36 Dec 06, 2016 Jkt 241001 action against prescribers has been limited to a handful of warning letters.382 These commenters proposed that the Commission amend Section 315.9 of the Rule, the enforcement provision, to add language to clarify that any violation of the Rule—by either sellers or prescribers—constitutes a violation of a rule under Section 18 of the Federal Trade Commission Act, subject to the same fines and penalties as any other violation of the Act.383 With respect to commenters’ recommendations that the Commission increase its enforcement efforts, the Commission notes that the rule review process has been instrumental in identifying areas that need further investigation. Accordingly, the Commission will consider ways to leverage its enforcement, consumer education,384 and business guidance efforts to address the concerns identified.385 However, the Commission does not believe it necessary to amend Section 315.9 of the Rule to clarify that violations by either sellers or prescribers constitute a violation of the Rule under Section 18 of the Federal Trade Commission Act. The language of the Act and Rule are clear on this point.386 E. Recommendations Regarding the Commission’s Complaint Reporting System The Commission received a variety of comments suggesting proposals to improve perceived shortcomings in the agency’s complaint reporting system to aid Rule enforcement efforts. Several optometric associations, for example, expressed their opinion that the 382 Id. 383 5 U.S.C. 57a. state optometric associations also encouraged the Commission to do more to ‘‘ensure that patients are aware that contact lenses are regulated medical devices, whose safe use and optimal performance depends on eye examinations and professional supervision.’’ Virginia Optometric Association (Comment #16); Wisconsin Optometric Association (Comment #30); Utah Optometric Association (Comment #39); Pennsylvania Optometric Association (Comment #46); Alabama Optometric Association (Comment #48); Iowa Optometric Association (Comment #79); Michigan Optometric Association (Comment #86); California Optometric Association (Comment #119); New Mexico Optometric Association (Comment #211); Mississippi Optometric Association (Comment #548); Ohio Optometric Association (Comment #556); Connecticut Association of Optometrists (Comment #560); North Carolina State Optometric Society (Comment #567); Tennessee Association of Optometric Physicians (Comment #575); Colorado Optometric Association (Comment #584); New Jersey Society of Optometric Physicians (Comment #595). 385 Furthermore, the Commission believes that the proposed Rule amendment requiring a signed acknowledgment of receipt of a contact lens prescription will also aid Rule enforcement efforts. See supra Section III.A.3. 386 See 15 U.S.C. 7608; 16 CFR 315.9. 384 The PO 00000 Frm 00030 Fmt 4701 Sfmt 4702 Commission’s consumer reporting process is not adequately designed to deal with contact lens complaints, and recommended that the Commission ‘‘develop a distinct complaint submission process for contact lensrelated concerns.’’ 387 More specifically, the American Optometric Association asserted that the online complaint assistant service is not appropriately set up to receive these types of complaints, and doctors who report issues of concern often feel their reports go unnoticed.388 This commenter stated that setting up a distinct Contact Lens Rule complaint system would benefit patients as well, providing them with a simple process to follow in case they have contact lens sale-related concerns.389 Likewise, the Coalition for Patient Vision Care Safety was troubled that the agency ‘‘routes eye contact complaints about non-compliance to its general complaint lines’’ and asserted that the general routing of complaints discourages the reporting of complaints and fails to provide the Commission with adequate and accessible information to enforce the Rule.390 The Coalition recommended that the Commission instead utilize dedicated personnel paired with a dedicated Web site or phone number within the Commission.391 Other commenters expressed doubts that the complaint reporting system was adequate to capture specific types of complaints. For example, two State representatives, Rhode Island State Rep. Brian Patrick Kennedy and Arizona State Rep. Heather Carter, asserted that the current system favors eye care providers and their ability to file complaints against resellers of contact lenses.392 These commenters recommended that the Commission consider simplifying the complaint process to make it easier for consumers 387 American Optometric Association (Comment #644); Virginia Optometric Association (Comment #16); Wisconsin Optometric Association (Comment #30); Utah Optometric Association (Comment #39); Pennsylvania Optometric Association (Comment #46); Alabama Optometric Association (Comment #48); Iowa Optometric Association (Comment #79); Michigan Optometric Association (Comment #86); California Optometric Association (Comment #119); New Mexico Optometric Association (Comment #211); Mississippi Optometric Association (Comment #548); Ohio Optometric Association (Comment #556); Connecticut Association of Optometrists (Comment #560); North Carolina State Optometric Society (Comment #567); Tennessee Association of Optometric Physicians (Comment #575); Colorado Optometric Association (Comment #584); New Jersey Society of Optometric Physicians (Comment #595). 388 Comment #644. 389 Id. 390 Comment #621. 391 Id. 392 Comments ##536, 545. E:\FR\FM\07DEP2.SGM 07DEP2 asabaliauskas on DSK3SPTVN1PROD with PROPOSALS Federal Register / Vol. 81, No. 235 / Wednesday, December 7, 2016 / Proposed Rules to file complaints against their eye care provider, as well as replacement contact lens resellers. Likewise, some online retailers recommended that to facilitate enforcement efforts the Commission should ‘‘create a user-friendly online complaint process for consumers.’’ 393 These commenters argued that the online complaint assistant is difficult to navigate and does not ask the appropriate questions to identify a Rule violation.394 After careful consideration of these comments, the Commission declines to redesign its complaint reporting mechanism. The Commission has designed the FTC Complaint Assistant, the agency’s online complaint reporting system, to be responsive to consumers who wish to file complaints about more than a hundred different types of products or services, while at the same time facilitating the filing of complaints regarding the most common complaint areas. Accordingly, the home page of the complaint system contains primary links for the FTC’s seven most common complaint areas. The Commission’s goal is that the primary links on the home page be responsive to at least 80 percent of the consumer complaints the agency receives. Although highlighting the most frequent types of complaints necessarily means that many areas of concern cannot be listed as separate categories, users can easily submit their complaint under the category ‘‘Other’’ when there is no listed category for the complaint, as is the case with contact lenses. Once the ‘‘Other’’ category is selected, the subsequent Web page includes the ‘‘Health and Fitness’’ subcategory, which is described as including, ‘‘prescriptions, eye care.’’ After screening out complaints related to telemarketing phone calls and spam email, the first option on the following Web page asks whether the complaint relates to ‘‘Eyeglasses or Contact Lenses.’’ During this process, the person lodging the complaint is given ample room to describe the details of the complaint. Instructions on the FTC Complaint Assistant page explain that the FTC will categorize a complaint even if it does not fit one of the listed categories. In addition, the Web page also informs users that if they are ‘‘having trouble categorizing [their] complaint,’’ they can chat online with FTC tech support. 393 1–800 CONTACTS (Comment #568); Warby Parker (Comment #593). See also LD Vision Group (Comment #544) (recommending that the Commission ‘‘[c]reate an online reporting mechanism for sellers and consumers to report unfair prescriber practices’’). 394 1–800 CONTACTS (Comment #568); Warby Parker (Comment #593). VerDate Sep<11>2014 20:36 Dec 06, 2016 Jkt 241001 Accordingly, the Commission believes that the FTC Complaint Assistant is configured to capture and report all contact lens-related complaints, whether they originate from consumers, prescribers, sellers, or others. However, resources permitting, the Commission will explore whether a dedicated email address would also be beneficial to complement the Complaint Assistant. VI. Request for Comment You can file a comment online or on paper. For the Commission to consider your comment, we must receive it on or before January 30, 2017. Write ‘‘Contact Lens Rule, 16 CFR part 315, Project No. R511995’’ on the comment. Your comment, including your name and your state, will be placed on the public record of this proceeding, including, to the extent practicable, on the public Commission Web site, at http:// www.ftc.gov/os/publiccomments.shtm. As a matter of discretion, the Commission tries to remove individuals’ home contact information from comments before placing them on the Commission Web site. Because your comment will be made public, you are solely responsible for making sure that your comment does not include any sensitive personal information, such as a Social Security number, date of birth, driver’s license number or other state identification number or foreign country equivalent, passport number, financial account number, or credit or debit card number. You are also solely responsible for making sure that your comment does not include any sensitive health information, such as medical records or other individually identifiable health information. In addition, do not include any ‘‘[t]rade secret or any commercial or financial information which is . . . privileged or confidential,’’ as discussed in Section 6(f) of the FTC Act, 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2). In particular, do not include competitively sensitive information such as costs, sales statistics, inventories, formulas, patterns, devices, manufacturing processes, or customer names. If you want the Commission to give your comment confidential treatment, you must file it in paper form, with a request for confidential treatment, and you must follow the procedure explained in FTC Rule 4.9(c), 16 CFR 4.9(c). In particular, the written request for confidential treatment that accompanies the comment must include the factual and legal basis for the request, and must identify the specific portions of the comments to be withheld from the public record. Your comment will be kept confidential only if the FTC PO 00000 Frm 00031 Fmt 4701 Sfmt 4702 88555 General Counsel grants your request in accordance with the law and the public interest. Postal mail addressed to the Commission is subject to delay due to heightened security screening. As a result, we encourage you to submit your comment online. To make sure that the Commission considers your online comment, you must file it at https:// ftcpublic.commentworks.com/ftc/ contactlensrule by following the instructions on the web-based form. If this Notice appears at http:// www.regulations.gov/#!home. you also may file a comment through that Web site. If you file your comment on paper, write ‘‘Contact Lens Rule, 16 CFR Part 315, Project No. R511995’’ on your comment and on the envelope, and mail your comment to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW., Suite CC–5610 (Annex C), Washington, DC 20580, or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW., 5th Floor, Suite 5610 (Annex C), Washington, DC 20024. Visit the Commission Web site at http://www.ftc.gov to read this Notice and the news release describing it. The FTC Act and other laws that the Commission administers permit the collection of public comments to consider and use in this proceeding as appropriate. The Commission will consider all timely and responsive public comments that it receives on or before January 30, 2017. For information on the Commission’s privacy policy, including routine uses permitted by the Privacy Act, see http://www.ftc.gov/ftc/ privacy.htm. The Commission invites members of the public to comment on any issues or concerns they believe are relevant or appropriate to the Commission’s consideration of proposed amendments to the Rule. The Commission requests you provide factual data, and in particular, empirical data, upon which your comments are based. In addition to the issues raised above, the Commission solicits public comment on the costs and benefits to industry members and consumers of each of the proposals as well as the specific questions identified below. These questions are designed to assist the public and should not be construed as a limitation on the issues on which public comment may be submitted. Questions A. General Questions on Proposed Amendments: To maximize the benefits E:\FR\FM\07DEP2.SGM 07DEP2 asabaliauskas on DSK3SPTVN1PROD with PROPOSALS 88556 Federal Register / Vol. 81, No. 235 / Wednesday, December 7, 2016 / Proposed Rules and minimize the costs for prescribers and sellers (including small businesses), the Commission seeks views and data on the following general questions for each of the proposed changes described in this NPRM: 1. What benefits would a proposed change confer and on whom? The Commission in particular seeks information on any benefits a change would confer on consumers of contact lenses. 2. What costs or burdens would a proposed change impose and on whom? The Commission in particular seeks information on any burdens a change would impose on small businesses. 3. What regulatory alternatives to the proposed changes are available that would reduce the burdens of the proposed changes while providing the same benefits? 4. What additional information, tools, or guidance might the Commission provide to assist industry in meeting extant or proposed requirements efficiently? 5. What evidence supports your answers? B. Acknowledgment of prescription release: 1. Would the proposed amendment to require prescribers, after the completion of a contact lens fitting, to request the contact lens patient acknowledge receipt of the contact lens prescription by signing an acknowledgment form increase, decrease, or have no effect on compliance with the Rule’s requirement that patients receive a copy of their contact lens prescription after the completion of the contact lens fitting? Why? 2. Would the proposed amendment to require prescribers to maintain copies of the signed acknowledgments for a period of not less than three years increase, decrease, or have no effect on the Commission’s ability to measure and enforce the Rule’s automatic prescription release provision? Why? 3. Would the proposed amendment to require the acknowledgment form to inform patients that they may purchase contact lenses from the seller of their choice increase, decrease, or have no effect on the extent to which patients understand their rights under the Rule? Why? 4. Should the Commission consider other language to be included in the signed acknowledgment form? If so, what? 5. Would allowing the acknowledgment form to be in either paper or electronic format increase, decrease, or have no effect on the extent to which patients understand their rights under the Rule? What other VerDate Sep<11>2014 20:36 Dec 06, 2016 Jkt 241001 factors should the Commission consider to lower the cost and improve the reliability of executing, storing, and retrieving the signed acknowledgment forms? 6. Should the proposed amendment contain specific language about the use of electronic acknowledgment forms and electronic signatures? If so, what? Should the proposed amendment contain particular requirements about the type of electronic acknowledgment forms and electronic signatures to be used? If so, what types should be required? 7. Are there alternate ways to structure a patient acknowledgment requirement that would reduce the burdens of the proposed amendment while providing the same, or greater, benefits? 8. What evidence supports your answers? C. Additional mechanisms for improving prescription portability: 1. The Commission believes that the use of patient portals to provide patients with access to electronic copies of their prescriptions would benefit prescribers, sellers, and patients. The Commission seeks comment on the benefits or burdens that the use of patient portals would confer. 2. The Commission seeks comment on the level of adoption of patient portals. Do prescribers use patient portals? Do patients use them? What are the rates of patient adoption when prescribers make them available? 3. What characteristics should patient portals have in order to best promote prescription portability? 4. Do patient portals have the potential to allow prescribers to comply with the automatic prescription release requirements of the Rule? If so, how? Do patient portals have limitations that would prevent them from being used by prescribers to comply with the automatic prescription release requirements of the Rule? If so, what are they? 5. If the Commission were to determine that patient portals could be used to comply with the automatic prescription release requirements of the Rule, how would this determination affect the requirement that prescribers obtain a signed acknowledgment form from patients? Do patient portals have characteristics that could serve as a substitute for the signed acknowledgment form? 6. What other technologies are available that could be implemented to improve prescription portability and thereby increase benefits and decrease burdens related to prescription release? PO 00000 Frm 00032 Fmt 4701 Sfmt 4702 7. What evidence supports your answers? D. Additional copies of prescriptions: 1. In this NPRM, the Commission has preliminarily determined that requiring prescribers to provide additional copies of contact lens prescriptions to a patient upon request is required by the Act. How does this determination affect, if at all, the portability of contact lens prescriptions? 2. Does this determination affect the accuracy of contact lens prescriptions presented to sellers? If so, how? 3. Does this determination affect the administrative burden of prescribers? If so, how? Would any burden caused by this determination be offset by a reduced burden related to prescription verification requests? If so, how? 4. What evidence supports your answers? E. Sellers designated to act on behalf of patients: 1. Should the Commission impose a timeframe for prescribers, under Section 315.3(a)(2) of the Rule, to respond to requests from authorized third parties for a copy of a patient’s prescription? 2. If so, what would be the appropriate amount of time for a prescriber to be required to respond to a request from an authorized third party for a copy of a patient’s prescription? 3. What evidence supports your answers? F. Presentation of prescription ‘‘directly or by facsimile’’ under Section 315.5(a)(1): 1. The Commission has initially determined that presenting a prescription to a seller ‘‘directly or by facsimile’’ includes the use of online patient portals. Does this determination further the Act’s goal of prescription portability? If so, how? 2. What is the impact, including costs and benefits, of this determination? 3. What evidence supports your answers? G. Automated telephone systems as ‘‘direct communication’’ under Section 315.5(a)(2): 1. What modifications to automated telephone calls, short of prohibiting the use of such calls, should the Commission consider to address the concerns raised by prescribers about the burden of such calls? H. Section 315.5(e)—No alteration of prescription provision: 1. To conform the language of the Rule to the language of the Act, the Commission proposes to amend Section 315.5(e) to strike the words ‘‘private label.’’ Would this proposed amendment alter the way that prescribers, sellers, or manufacturers do business, and if so, how? E:\FR\FM\07DEP2.SGM 07DEP2 Federal Register / Vol. 81, No. 235 / Wednesday, December 7, 2016 / Proposed Rules 2. Are there alternative proposals that the Commission should consider? 3. What evidence supports your answers? VII. Communications by Outside Parties to the Commissioners or Their Advisors Written communications and summaries or transcripts of oral communications respecting the merits of this proceeding, from any outside party to any Commissioner or Commissioner’s advisor, will be placed on the public record. See 16 CFR 1.26(b)(5). asabaliauskas on DSK3SPTVN1PROD with PROPOSALS VIII. Paperwork Reduction Act The existing Rule contains recordkeeping and disclosure requirements that constitute ‘‘information collection requirements’’ 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. OMB has approved the Rule’s existing information collection requirements. (OMB Control No. 3084–0127). The proposed modifications to the Rule would require that prescribers obtain from patients, and maintain for a period of not less than three years, a signed acknowledgment form, entitled ‘‘Patient Receipt of Contact Lens Prescription,’’ confirming that patients received their contact lens prescriptions at the completion of their contact lens fitting. The proposed recordkeeping requirement would constitute an information collection as defined by 5 CFR 1320.3(c). Accordingly, the Commission is providing PRA burden estimates for them, as set forth below. The Commission will also submit this notice of proposed rulemaking and associated Supporting Statement to OMB for review under the PRA. The proposed requirement that prescribers provide an acknowledgment form to patients, however, does not constitute an information collection under the PRA, in that the Rule specifies the language that the form must contain.395 A. Estimated Additional Hours Burden Commission staff estimates the paperwork burden of the proposed modifications based on its knowledge of the eye care industry. The staff believes there will be an additional burden on individual prescribers’ offices to maintain the signed acknowledgment 395 The public disclosure of information originally supplied by the Federal government to the recipient for the purpose of disclosure to the public is not a ‘‘collection of information.’’ 5 CFR 1320.3(c)(2). VerDate Sep<11>2014 20:36 Dec 06, 2016 Jkt 241001 forms for a period of not less than three years. The number of contact lens wearers in the United States is currently estimated to be approximately 41 million.396 Therefore, assuming an annual contact lens exam for each contact lens wearer, approximately 41 million people would read and sign an acknowledgment form every year.397 Maintaining the form for a period of not less than three years does not impose a substantial new burden on individual prescribers and their office staff. The majority of states already require that optometrists maintain records of eye examinations for at least three years,398 and maintaining a onepage acknowledgment form per patient per year should not take more than a few seconds of time, and an inconsequential, or de minimis, amount of record space. Some prescribers might present the acknowledgment form electronically, and such format would allow the signed acknowledgment to be preserved without any additional burden. For other prescribers, the new recordkeeping requirement would likely require that office staff either preserve the signed acknowledgment form in paper format or electronically scan the signed acknowledgment form and save it as an electronic document. In the latter scenario, the Commission estimates this scanning and saving would take approximately one minute. The Commission does not possess any information regarding the percentage of prescribers’ offices that use paper forms, electronic forms, or that scan paper files and maintain them electronically. Therefore, for purposes of this notice, staff will assume that all prescriber offices require a full one minute per form per year for record maintenance purposes arising from the proposed modifications. As noted above, the number of contact lens wearers in the United States is currently estimated to be approximately 396 Cope, supra note 29, at 866. the past, some commenters have suggested that typical contact lens wearers obtain annual exams every 18 months or so, rather than one every year. However, because most prescriptions are valid for a minimum of one year under the Rule, and use of a longer exam cycle would lead to an estimate of a lower number of signed acknowledgment forms and a reduced burden, we continue to estimate that patients seek exams every 12 months. 398 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). 397 In PO 00000 Frm 00033 Fmt 4701 Sfmt 4702 88557 41 million. Therefore, assuming one signed acknowledgment form for each contact lens wearer per year, prescribers’ offices, collectively, would have to spend approximately 41 million minutes, or 683,333 hours, per year maintaining records of eye examinations (recordkeeping requirement). In all likelihood, the actual overall increased burden on prescribers may be less than 683,333 hours, because increasing the number of patients in possession of their prescriptions should correspondingly increase the number of consumers who provide their prescriptions to third-party sellers when purchasing contact lenses. This, in turn, should reduce the number of verification requests that third-party sellers would otherwise make to prescribers. Based on current estimates, responding to verification requests requires that prescribers spend approximately five minutes per request.399 The Commission, however, does not presently have enough information to devise a reliable estimate for how many more consumers are likely to present third-party sellers with a complete copy of their prescription following the proposed Rule modification. Therefore, for purposes of calculating the burden, the Commission, at this time, will not credit the expected reduction in verification burden. B. Estimated Total Labor Cost Burden Commission staff derives labor costs by applying appropriate hourly cost figures to the burden hours described above. The Commission assumes that office clerks will perform most of the labor when it comes to printing, disseminating, and storing the acknowledgment forms for prescribers’ offices. According to Bureau of Labor Statistics, general office clerks earn an average wage of $15.33 per hour.400 Based on this data, the estimated total additional labor cost attributable to the proposed modifications to the Rule would amount to approximately $10,475,495. While not insubstantial, this amount constitutes just under one-fourth of one percent of the estimated overall retail market for contact lens sales in the 399 See American Optometric Association, Comment in response to the Agency Information Collection Activities; Proposed Collection; Comment Request, 81 FR 31938 (May 20, 2016), https://www.ftc.gov/policy/public-comments/ initiative-665. 400 Press Release, U.S. Dep’t of Labor, Bureau of Labor Statistics, ‘‘Occupational Employment Statistics—May 2015,’’ http://www.bls.gov/ news.release/ocwage.t01.htm. E:\FR\FM\07DEP2.SGM 07DEP2 88558 Federal Register / Vol. 81, No. 235 / Wednesday, December 7, 2016 / Proposed Rules United States.401 Furthermore, the burden is likely to be less, because many prescribers’ offices will not require a full minute to store the acknowledgment form. And, as noted above, increasing the number of patients in possession of their prescriptions should correspondingly increase the number of consumers who provide their prescriptions to third-party sellers when purchasing contact lenses. This, in turn, could potentially reduce the number of verification requests made to prescribers, and the time prescribers spend responding. The Commission invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (2) the accuracy of the FTC’s burden estimates, including whether the methodology and assumptions used are valid; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of collecting information. Comments on the information collection requirements subject to review under the PRA should also be submitted to Office of Management and Budget. If sent by U.S. mail, address comments to: Office of Information and Regulatory Affairs, Office of Management and Budget, Attention: Desk Officer for the Federal Trade Commission, New Executive Office Building, Docket Library, Room 10102, 725 17th Street NW., Washington, DC 20503. Comments sent to OMB by U.S. postal mail, however, are subject to delays due to heightened security precautions. Thus, comments instead should be sent by facsimile to (202) 395–5167. asabaliauskas on DSK3SPTVN1PROD with PROPOSALS IX. Regulatory Flexibility Act The Regulatory Flexibility Act (‘‘RFA’’) 402 requires the Commission to conduct an analysis of the anticipated economic impact of the proposed amendments on small entities.403 The purpose of a regulatory flexibility analysis is to ensure the agency considers the impacts on small entities and examines regulatory alternatives that could achieve the regulatory 401 According to The Vision Council, the contact lens sales market in the United States in 2015 totaled $4,664,200,000 at the retail level. See The Vision Council, ‘‘U.S. Optical Industry Report Card,’’ Dec. 2015. The estimated additional burden of $10,475,495 thus amounts to approximately 0.22% of the total market. 402 5 U.S.C. 601–612. 403 The Commission also conducted an RFA analysis of prior amendments to the Rule implementing the Fairness to Contact Lens Consumers Act. 69 FR 40482, 40507 (July 2, 2004). VerDate Sep<11>2014 20:36 Dec 06, 2016 Jkt 241001 purpose while minimizing burdens on small entities. Section 605 of the RFA 404 provides that such an analysis is not required if the agency head certifies that the regulatory action will not have a significant economic impact on a substantial number of small entities. The Commission does not anticipate that the proposed amendments will have a significant economic impact on small entities, although they may affect a substantial number of small businesses. The proposed amendments require that prescribers obtain from patients, and maintain for a period of not less than three years, a signed acknowledgment form, entitled ‘‘Patient Receipt of Contact Lens Prescription,’’ confirming that patients received their contact lens prescriptions at the completion of their contact lens fitting. The Commission believes the burden of complying with this requirement likely will be relatively small. As discussed in the Paperwork Reduction Act section, the majority of states already require that optometrists maintain records of eye examinations for at least three years. The proposed amendment would require one additional page to be maintained as a record, which is likely a minimal burden. Therefore, based on available information, the Commission certifies that amending the Rule as proposed will not have a significant economic impact on a substantial number of small businesses. Although the Commission certifies under the RFA that the proposed amendment will not, if promulgated, have a significant impact on a substantial number of small entities, the Commission has nonetheless determined it is appropriate to publish an Initial Regulatory Flexibility Analysis to inquire into the impact of the proposed amendment on small entities. Therefore, the Commission has prepared the following analysis: A. Description of the Reasons the Agency Is Taking Action In response to public comments, the Commission proposes amending the Rule to ensure that patients are receiving a copy of their contact lens prescription at the completion of a contact lens fitting. B. Statement of the Objectives of, and Legal Basis for, the Proposed Amendments The objective of the proposed amendment is to clarify and update the Rule in accordance with marketplace practices. The legal basis for the Rule is 404 5 PO 00000 U.S.C. 605. Frm 00034 Fmt 4701 Sfmt 4702 the Fairness to Contact Lens Consumers Act.405 The Act authorizes the Commission to implement its requirements through the issuance of rules. C. Small Entities to Which the Proposed Amendments Will Apply The proposed amendments apply to prescribers of contact lenses. The Commission believes that many prescribers will fall into the category of small entities (e.g., offices of optometrists less than $7.5 million in size).406 Determining a precise estimate of the number of small entities covered by the Rule’s prescription release requirements is not readily feasible because most prescribers’ offices do not release the underlying revenue information necessary to make this determination.407 Based on its knowledge of the eye care industry, staff believes that a substantial number of these entities likely qualify as small businesses. The Commission seeks comment with regard to the estimated number or nature of small business entities, if any, for which the proposed amendments would have a significant impact. D. Projected Reporting, Recordkeeping, and Other Compliance Requirements, Including Classes of Covered Small Entities and Professional Skills Needed To Comply As explained earlier in this document, the proposed amendments require that prescribers obtain from patients, and maintain for a period of not less than three years, a signed acknowledgment form, entitled ‘‘Patient Receipt of Contact Lens Prescription,’’ confirming that patients received their contact lens prescriptions at the completion of their contact lens fitting. The small entities potentially covered by these proposed amendments will include all such entities subject to the Rule. The professional skills necessary for compliance with the Rule as modified by the proposed amendments will include office and administrative support supervisors to create the acknowledgment form and clerical personnel to collect signatures from patients and maintain records. The Commission believes the burden imposed on small businesses by these requirements is relatively small, for the reasons described previously in Section 405 15 U.S.C. 7601–7610. 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. 407 5 U.S.C. 601(6). 406 See E:\FR\FM\07DEP2.SGM 07DEP2 Federal Register / Vol. 81, No. 235 / Wednesday, December 7, 2016 / Proposed Rules VIII of this notice. The Commission invites comment and information on these issues, including estimates or data on specific compliance costs that small entities might be expected to incur. E. Duplicative, Overlapping, or Conflicting Federal Rules The Commission has not identified any other federal statutes, rules, or policies duplicating, overlapping, or conflicting with the proposed amendments, but as noted previously, the majority of states already require that optometrists—of which many are most likely small businesses—maintain records of eye examinations for at least three years. The Commission invites additional comment on this issue. asabaliauskas on DSK3SPTVN1PROD with PROPOSALS F. Significant Alternatives to the Proposed Amendments The Commission has not proposed any specific small entity exemption or other significant alternatives, as the proposed amendments clarify and update the Rule in light of marketplace practices to ensure that patients are receiving a copy of their contact lens prescription at the completion of a contact lens fitting. Under these limited circumstances, the Commission does not believe a special exemption for small entities or significant compliance alternatives are necessary or appropriate to minimize the compliance burden, if any, on small entities while achieving the intended purposes of the proposed amendments. As discussed above, the proposed recordkeeping requirement likely involves minimal burden and prescribers would be permitted to maintain records in either paper or electronic format. This recordkeeping burden could be reduced to the extent that prescribers have adopted electronic medical record systems, especially those where patient signatures can be recorded electronically and input automatically into the electronic record. Furthermore, prescribers also could VerDate Sep<11>2014 20:36 Dec 06, 2016 Jkt 241001 scan signed paper copies of the acknowledgment form and store those forms electronically to lower the costs of this recordkeeping requirement. Nonetheless, the Commission seeks comment on the need, if any, for alternative compliance methods to reduce the economic impact of the Rule on small entities. If the comments filed in response to this NPRM identify small entities affected by the proposed amendments, as well as alternative methods of compliance that would reduce the economic impact of the proposed amendments on such entities, the Commission will consider the feasibility of such alternatives and determine whether they should be incorporated into the final Rule. X. Proposed Rule Language List of Subjects in 16 CFR Part 315 Advertising, Medical devices, Ophthalmic goods and services, Trade practices. Under 15 U.S.C 7601–7610 and as discussed in the preamble, the Federal Trade Commission proposes to amend title 16 of the Code of Federal Regulations by revising part 315 as follows: PART 315—CONTACT LENS RULE 1. The authority citation for part 315 continues to read as follows: ■ Authority: Pub. L. 108–164, secs. 1–12; 117 Stat. 2024 (15 U.S.C. 7601–7610). 2. Amend § 315.3 by adding paragraph (c) to read as follows: ■ § 315.3 Availability of contact lens prescriptions to patients. * * * * * (c) Acknowledgment of prescription release. Upon completion of a contact lens fitting, and after providing a copy of the contact lens prescription to the patient, the prescriber: (1) Shall request that the contact lens patient acknowledge receipt of the PO 00000 Frm 00035 Fmt 4701 Sfmt 9990 88559 contact lens prescription by signing an acknowledgment form entitled, ‘‘Patient Receipt of Contact Lens Prescription’’ that states, ‘‘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.’’ (2) The acknowledgment form shall include, in addition to the title and statement specified in paragraph (c)(1), the name of the patient, the patient signature, and the date executed. In the event that the patient declines to sign the acknowledgment form, the prescriber shall note the patient’s refusal on the form and sign it. No other statements or information, other than the address or letterhead of the prescriber, shall be placed on the acknowledgment form. (3) The prescriber shall maintain the signed acknowledgments received under paragraph (c)(1) for a period of not less than three (3) years, and such signed acknowledgments shall be available for inspection by the Federal Trade Commission, its employees, and its representatives. ■ 3. Amend § 315.5 paragraph (e) by revising the second sentence to read as follows: § 315.5 Prescriber verification. * * * * * (e) * * * Notwithstanding the preceding sentence, a seller may substitute for contact lenses specified on a prescription identical contact lenses that the same company manufactures and sells under different labels. * * * * * By direction of the Commission. Donald S. Clark, Secretary. [FR Doc. 2016–28471 Filed 12–6–16; 8:45 am] BILLING CODE 6750–01–P E:\FR\FM\07DEP2.SGM 07DEP2

Agencies

[Federal Register Volume 81, Number 235 (Wednesday, December 7, 2016)]
[Proposed Rules]
[Pages 88526-88559]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-28471]



[[Page 88525]]

Vol. 81

Wednesday,

No. 235

December 7, 2016

Part V





Federal Trade Commission





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16 CFR Part 315





Contact Lens Rule; Proposed Rule

Federal Register / Vol. 81 , No. 235 / Wednesday, December 7, 2016 / 
Proposed Rules

[[Page 88526]]


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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: Notice of proposed rulemaking; request for public comment.

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SUMMARY: As part of its regulatory review of the Contact Lens Rule 
(``Rule''), and consistent with the requirements of the Fairness to 
Contact Lens Consumers Act (the ``Act''), the Federal Trade Commission 
proposes to amend the Rule to require that prescribers obtain a signed 
acknowledgment after releasing a contact lens prescription to a 
patient, and maintain each such acknowledgment for a period of not less 
than three years. The Commission seeks comment on this proposal and 
several other issues.

DATES: Written comments must be received on or before January 30, 2017.

ADDRESSES: Interested parties may file a comment online or on paper by 
following the instructions in the Request for Comment part of the 
SUPPLEMENTARY INFORMATION section below. Write ``Contact Lens Rule, 16 
CFR part 315, Project No. R511995'' on your comment, and file your 
comment online at https://ftcpublic.commentworks.com/ftc/contactlensrule by following the instructions on the web-based form. If 
you prefer to file your comment on paper, write ``Contact Lens Rule, 16 
CFR part 315, Project No. R511995'' on your comment and on the envelope 
and mail your comment to the following address: Federal Trade 
Commission, Office of the Secretary, 600 Pennsylvania Avenue NW., Suite 
CC-5610 (Annex C), Washington, DC 20580, or deliver your comment to the 
following address: Federal Trade Commission, Office of the Secretary, 
Constitution Center, 400 7th Street SW., 5th Floor, Suite 5610 (Annex 
C), Washington, DC 20024.

FOR FURTHER INFORMATION CONTACT: Elizabeth Delaney, Attorney, (202) 
326-2903, or Paul Spelman, Attorney, (202) 326-2487, Division of 
Advertising Practices, Bureau of Consumer Protection, Federal Trade 
Commission, 600 Pennsylvania Avenue NW., Washington, DC 20580.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background
    A. Overview of the Contact Lens Rule
    B. Regulatory History
    C. The Evolving Contact Lens Marketplace
II. Contact Lens Rule Review
III. Availability of Contact Lens Prescriptions to Patients
    A. Section 315.3(a)(1)--Automatic Prescription Release
    1. Compliance With the Automatic Prescription Release 
Requirement
    2. Commenter Suggestions for Improving Automatic Prescription 
Release Compliance
    3. Analysis of Proposals for Improving Automatic Prescription 
Release Compliance and Commission Proposal
    (a) Proposal To Increase Enforcement
    (b) Proposal To Require an Eye Care Patients' Bill of Rights or 
Notice-Upon-Check-In
    (c) Proposal To Require a Signed Acknowledgment Form
    (d) Proposal To Require Signage
    (e) The Commission's Proposal To Require a Signed Acknowledgment
    4. Additional Mechanisms for Improving Prescription Portability
    B. Section 315.3(a)(1)--Additional Copies of Prescriptions
    C. Section 315.3(a)(2)--Provide or Verify the Contact Lens 
Prescription
    1. Sellers Designated To Act on Behalf of Patients
IV. Prescriber Verification
    A. Section 315.5(a)--Prescription Requirement
    1. Presentation of Prescriptions ``Directly or By Facsimile''
    2. ``Verified by Direct Communication''
    3. Automated Telephone Calls as a Method of Direct Communication
    B. Section 315.5(b)--Information for Verification
    1. Vendor Contact Information
    2. Prescribers' Selection of Communication Mechanism
    C. Section 315.5(c)--Verification Events
    1. Passive Verification
    2. Issues Regarding the Eight-Business-Hour-Window
V. Contact Lens Prescriptions
    A. Section 315.6--Expiration of Contact Lens Prescriptions
    1. Length of Contact Lens Prescriptions
    2. Expired Contact Lens Prescriptions
    3. Quantities of Contact Lenses Obtained by Patients
    B. Private Label Lenses and Contact Lens Substitution
    1. Private Label Lenses
    2. Alteration of Contact Lens Prescriptions by Sellers
    C. HIPAA Issues
    D. Enforcement Efforts
    E. Recommendations Regarding the Commission's Complaint 
Reporting System
VI. Request for Comment
VII. Communications by Outside Parties to the Commissioners or Their 
Advisors
VIII. Paperwork Reduction Act
    A. Estimated Additional Hours Burden
    B. Estimated Total Labor Cost Burden
IX. Regulatory Flexibility Act
    A. Description of the Reasons the Agency Is Taking Action
    B. Statement of the Objectives of, and Legal Basis for, the 
Proposed Amendments
    C. Small Entities to Which the Proposed Amendments Will Apply
    D. Projected Reporting, Recordkeeping, and Other Compliance 
Requirements, Including Classes of Covered Small Entities and 
Professional Skills Needed To Comply
X. Proposed Rule Language

I. Background

A. Overview of the Contact Lens Rule

    In 2003, Congress enacted the Fairness to Contact Lens Consumers 
Act,\1\ and pursuant to the Act, the Commission promulgated the Contact 
Lens Rule on July 2, 2004.\2\ The Rule went into effect on August 2, 
2004.
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    \1\ 15 U.S.C. 7601-7610 (Pub. L. 108-164).
    \2\ Contact Lens Rule, 16 CFR 315 (2015).
---------------------------------------------------------------------------

    The Contact Lens Rule promotes competition in retail sales of 
contact lenses by facilitating consumers' ability to comparison shop 
for contact lenses. When a prescriber completes a contact lens fitting, 
the Rule requires that the prescriber provide the patient with a 
portable copy of her prescription. The Rule also requires that the 
prescriber verify or provide such prescriptions to authorized third 
parties. At the same time, the Rule requires that contact lens vendors 
only sell contact lenses in accordance with valid prescriptions written 
by licensed prescribers.
    The Rule specifies that a prescriber may not require: (1) The 
purchase of contact lenses as a condition of providing the prescription 
or verification; (2) payment in addition to, or as a part of, the fee 
for an eye examination, fitting, and evaluation as a condition of 
providing the prescription or verification; or (3) the patient to sign 
a waiver or release as a condition of releasing or verifying the 
prescription.\3\ The prescriber is also prohibited from requiring 
immediate payment before the release of a prescription, unless the 
prescriber requires immediate payment when an exam reveals that the 
consumer does not need ophthalmic goods.\4\
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    \3\ 16 CFR 315.3(b).
    \4\ 16 CFR 315.4.
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    The Rule also places certain requirements on sellers. It mandates 
that sellers dispense contact lenses only in accordance with a valid 
prescription that is either presented to the seller or verified by 
direct communication with the prescriber.\5\ The Rule sets out the 
information that must be included in a seller's verification request, 
and directs that a prescription is only verified under the Rule if: (1) 
A prescriber confirms the prescription is accurate; (2) a prescriber 
informs the seller that the prescription is inaccurate and provides an 
accurate

[[Page 88527]]

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 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\
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    \5\ 16 CFR 315.5(a).
    \6\ 16 CFR 315.5(b)-(c).
    \7\ 16 CFR 315.5(d).
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    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\ Sellers and others 
involved in the manufacture, assembly, processing, and distribution of 
contact lenses are prohibited from representing that contact lenses may 
be obtained without a prescription.\9\
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    \8\ 16 CFR 315.5(e).
    \9\ 16 CFR 315.7.
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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.\10\ 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.\11\
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    \10\ 16 CFR 315.6.
    \11\ 16 CFR 315.11(a). The Rule states further that ``[a]ny 
other state or local laws or regulations that are inconsistent with 
the Act or this part are preempted to the extent of the 
inconsistency.'' 16 CFR 315.11(b).
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B. Regulatory History

    The FTC has more than three decades of regulatory and research 
experience regarding the optical goods industry. In addition to the 
Contact Lens Rule, the Commission enforces the Ophthalmic Practice 
Rules (hereinafter ``Eyeglass Rule''), initially promulgated in 
1978.\12\ Prior to the Eyeglass Rule, many prescribers either refused 
to release prescriptions to their patients or charged an additional fee 
to do so.\13\ Prices for glasses varied widely, but without their 
prescriptions, or without paying a fee to obtain their prescriptions, 
consumers could not comparison shop among prescribers and other vendors 
and purchase from sellers that best met their needs for price, service, 
and convenience.\14\ Moreover, competition did not lead the industry to 
offer what consumers could not choose: when consumers' ability to 
comparison shop is diminished, the normal competitive pressures on the 
eye care industry to offer competitive prices--or the combination of 
prices, features, and services most in demand--are themselves 
diminished. To address this problem, the Eyeglass Rule requires 
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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    \12\ Advertising of Ophthalmic Goods and Services, 43 FR 23992 
(June 2, 1978). The Rule was revised in 1992, with the revisions 
codified at 16 CFR 456. Ophthalmic Practice Rules, 57 FR 18822 (May 
1, 1992).
    \13\ 43 FR at 23998. The Commission found, for example, that in 
nearly every survey of practicing optometrists considered in the 
rulemaking record, more than 50% of optometrists imposed a 
restriction on the availability of eyeglass prescriptions to 
patients. See id.
    \14\ Fed. Tr. Comm'n, ``The Strength of Competition in the Sale 
of Rx Contact Lenses: An FTC Study,'' 45-46 (2005), http://www.ftc.gov/reports/contactlens/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 Fed. Tr. Comm'n, Bureau of 
Economics Staff Paper, ``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.
---------------------------------------------------------------------------

    Consumers, sellers, and state officials complained that contact 
lens consumers faced similar hurdles when trying to comparison shop for 
contact lenses.\16\ To achieve freedom of choice and the benefits of 
competition for contact lens consumers, in 2003, Congress passed the 
Fairness to Contact Lens Consumers Act,\17\ and as the Act required, in 
2004, the Commission issued the Contact Lens Rule,\18\ implementing the 
Act.
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    \16\ For example, in In re Disposable Contact Lens Antitrust 
Litigation, the Attorneys General of 31 states and a certified class 
alleged that eye care professionals engaged in an organized effort 
to prevent or hinder consumers from obtaining their contact lens 
prescriptions. In re Disposable Contact Lens Antitrust Litigation, 
No. 94-MDL 1030-J-20A (M.D. Fla.). 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 complaints, 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, defendant manufacturers 
agreed to sell contact lenses to alternative distribution channels.
    \17\ 15 U.S.C. 7601-7610 (Pub. L. 108-164).
    \18\ Contact Lens Rule, 69 FR 40482 (July 2, 2004) (codified at 
16 CFR 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.
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    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,\19\ the Act requires that 
contact lenses be sold only to patients with valid prescriptions, which 
they receive after contact lens fittings. As noted above, the Act and 
the Contact Lens Rule only allow sales of contact lenses when the 
seller has a copy of the patient's prescription or has verified that 
prescription with the prescriber.\20\ Sellers also are prohibited from 
altering a contact lens prescription.\21\ The U.S. Food and Drug 
Administration (``FDA'') has strict labeling requirements for contact 
lenses, and it has the authority to take action against the sales of 
such lenses, which are medical devices, without a valid 
prescription.\22\
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    \19\ See, e.g., Fed. Tr. Comm'n, ``Possible Barriers to E-
Commerce: Contact Lenses, A Report from the Staff of the Federal 
Trade Commission,'' 8-9 (Mar. 2004), http://www.ftc.gov/os/2004/03/040329clreportfinal.pdf [hereinafter 2004 Possible Barriers to E-
Commerce Report].
    \20\ 16 CFR 315.5(a).
    \21\ 16 CFR 315.5(e).
    \22\ See 21 U.S.C. 331(a), 333, 352(f), and 353(b)(1).
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    Because of concerns that many prescribers had impeded consumers' 
ability to comparison shop for contact lenses--even following 
appropriate diagnosis and fitting by the prescribers--the Act and the 
Rule also impose obligations on the prescribers themselves. As noted 
above, prescribers are required to release a copy of the prescription 
to the consumer, promptly upon completion of the contact lens fitting, 
``[w]hether or not requested by the patient.'' \23\ That copy must be 
complete and portable to enable comparison shopping: it must contain 
``sufficient information for the complete and accurate filling of a 
prescription.'' \24\ Prescribers also are prohibited from requiring the 
purchase of contact lenses as a condition of either prescription 
release or verification, from requiring a separate payment for 
prescription release or verification, and from requiring that the 
patient sign a waiver as a condition of prescription release or 
verification.\25\
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    \23\ 15 U.S.C. 7601(a)(1); 16 CFR 315.3(a)(1).
    \24\ 15 U.S.C. 7610(3); 16 CFR 315.2.
    \25\ 15 U.S.C. 7601(b)(1)-(3); 16 CFR 315.3(b)(1)-(3).
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    Prescribers also are required to provide or verify a contact lens

[[Page 88528]]

prescription when ``directed by any person designated to act on behalf 
of the patient.'' \26\ Sales of contact lenses require a valid 
prescription that is verified by a prescriber. Such verification takes 
place: (1) When the prescriber confirms that the prescription is 
accurate, by phone, facsimile, or electronic mail; (2) when the 
prescriber informs the seller that the prescription is inaccurate and 
provides the correct prescription; or (3) when the seller seeks 
verification of a given prescription from a prescriber, and the 
prescriber does not communicate with the seller within eight business 
hours of the seller's request for information.\27\ This eight-hour, 
default ``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--simply by refusing to respond to verification requests.
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    \26\ 15 U.S.C. 7601(a)(2) (must, as directed by authorized 
party, ``provide or verify'' the prescription); 16 CFR 315.3(a)(2).
    \27\ 15 U.S.C. 7603(d)(1)-(3); 16 CFR 315.5.
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C. The Evolving Contact Lens Marketplace

    When contact lenses were first introduced, they were made of rigid 
material that required a prescriber to custom fit each pair. Beginning 
in the late 1980s, manufacturers began to sell disposable lenses, 
designed to be replaced on a daily, weekly, or monthly basis. In 
addition, technological advances resolved most lens-standardization 
issues, eliminating the need for a prescriber to fit each pair to the 
individual once the initial prescription had been finalized. Today, the 
vast majority of replacement lenses bought pursuant to an individual's 
prescription will be identical, regardless of whether the patient 
purchases them from the prescriber or a third-party seller.\28\ This 
enables the sale of lenses to be unbundled from the fitting exam, and 
makes it feasible for non-prescribers to sell contact lenses.
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    \28\ However, contact lens prescriptions are brand specific, and 
as a general matter, one brand cannot be substituted for another, 
even if the other technical parameters (power, base curve, diameter, 
cylinder, and axis) are identical. As noted previously, sellers may 
substitute identical contact lenses that the same company 
manufactures and sells under a different name.
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    These technological advances have increased the comfort and 
convenience of contact lenses, leading to growth in the number of 
contact lens wearers, and changes in the type and variety of lenses 
worn. According to the U.S. Centers for Disease Control and Prevention 
(``CDC''), there are now approximately 40.9 million contact lens 
wearers in the United States age 18 and older, representing more than 
16% of the population.\29\
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    \29\ Jennifer R. Cope et al., ``Contact Lens Wearer Demographics 
and Risk Behaviors for Contact Lens-Related Eye Infections--United 
States, 2014,'' Morb. Mortal. Wkly. Rep. 64(32):865-70, 866 (Aug. 
21, 2015). See also Vision Council, ``Consumer Barometer,'' Sept. 
2015 (estimating that 16.2% of American adults wear contact lenses).
---------------------------------------------------------------------------

    Overall, the U.S. market for contact lenses currently is estimated 
to be between $4 billion and $5 billion annually.\30\ Of that, 
approximately 40% of sales are made by independent eye care 
professionals (optometrists and ophthalmologists), 19% by conventional 
retail chains (such as LensCrafters, etc.), 25% from mass merchants and 
wholesale clubs (such as Costco, Sam's Club, etc.), and 18% by online 
sellers (16% of sales are by ``pure play'' online sellers, such as 1-
800 CONTACTS, that do not have a physical retail presence).\31\ By 
contrast, in 2006, the total U.S. market for contact lenses was 
approximately $3.3 billion, with estimated online sales representing 
less than 13% of the market.\32\
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    \30\ See Vision Council, ``Consumer Barometer,'' Mar. 2014 
(valuing the U.S. contact lens market at $4.2 billion); Vision 
Council, ``Consumer Barometer,'' Sept. 2015 (valuing the U.S. 
contact lens market at $4.6 billion).
    \31\ Vision Council, ``U.S. Optical Industry Report Card,'' Dec. 
2015.
    \32\ See Vision Council, supra note 30.
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    There also are significantly more types of lenses in the U.S. now 
than there were 10 to 15 years ago.\33\ At the same time, use of daily 
disposable lenses increased from just 7.5% in 2005 to 28% in 2015, 
while use of conventional one-year lenses declined sharply, from 19% to 
1%.\34\
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    \33\ These include, among others, soft spherical (common soft 
lenses), soft toric (lenses for astigmatic patients), soft 
multifocal (lenses for presbyotic patients), spherical corneal GP 
(rigid lenses for presbyotic and astigmatic patients), and scleral 
(lenses for patients with corneal irregularities). Furthermore, 
according to Johnson & Johnson Vision Care, Inc., more than 160 
different brands of contact lenses are available. Comment #582. See 
also Jason J. Nichols, ``2015 Annual Report,'' Contact Lens 
Spectrum, Jan. 1, 2016, http://www.clspectrum.com/articleviewer.aspx?articleID=113689.
    \34\ Carla J. Mack, ``Annual Report, Contact Lenses 2007,'' 
Contact Lens Spectrum, Jan. 1, 2008, http://www.clspectrum.com/articleviewer.aspx?articleID=101240; Nichols, supra note 33.
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II. Contact Lens Rule Review

    On September 3, 2015, the Commission solicited comments on the 
Contact Lens Rule as part of its periodic review of its rules and 
guides.\35\ The Commission sought comments on: The economic impact of, 
and the 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. The comment period closed on October 26, 
2015.
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    \35\ Contact Lens Rule, Request for Comment, 80 FR 53272 (Sept. 
3, 2015).
---------------------------------------------------------------------------

    This Notice of Proposed Rulemaking (``NPRM'') summarizes the 
comments received and explains the Commission's decision to retain the 
Contact Lens Rule. It also explains why the Commission proposes certain 
amendments and why it declines to propose others. Additionally, it 
seeks comment on certain questions. Finally, the NPRM sets forth the 
Commission's regulatory analyses under the Regulatory Flexibility and 
Paperwork Reduction Acts, as well as the text of the proposed 
amendments.
    The Commission received 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 consumer and 
competition advocates.\36\ Virtually all commenters agreed that there 
is a continuing need for the Rule and that it benefits consumers and 
competition. The majority of commenters recommended some modifications 
to the Rule in order to maximize the benefits to consumers and 
competition, decrease the burden on businesses, protect consumers' eye 
health, or improve overall compliance with the Rule's existing 
requirements. Many commenters--including prescribers, sellers, 
manufacturers, legislators, and consumer advocates--also indicated that 
increased enforcement efforts would be beneficial.
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    \36\ The comments are posted at: https://www.ftc.gov/policy/public-comments/initiative-621. The Commission has assigned each 
comment a number appearing after the name of the commenter and the 
date of submission. This notice cites comments using the last name 
of the individual submitter or the name of the organization, 
followed by the number assigned by the Commission.
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    Some commenters--including contact lens sellers, opticians, state 
and federal legislators, consumer advocacy groups, and others--stated 
that the Act's intent to provide a competitive marketplace is

[[Page 88529]]

not being fully realized because prescribers are not complying with one 
of the major underpinnings of the Rule: the automatic release of 
prescriptions to patients.\37\ Some commenters also asserted that some 
prescribers are interfering with the prescription verification process 
and thereby impeding consumers' ability to comparison shop.\38\
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    \37\ See, e.g., Utah Retail Merchants Association (Comment #28); 
Information Technology & Innovation Foundation (Comment #40); Rhode 
Island State Representative Kennedy (Comment #536); Arizona State 
Representative Carter (Comment #545); Utah State Senator Bramble 
(Comment #576); Lens.com (Comment #614); Consumers Union (Comment 
#677).
    \38\ See, e.g., LD Vision Group (Comment #544); National 
Association of Optometrists and Opticians (Comment #549); 1-800 
CONTACTS (Comment #568); Warby Parker (Comment #593).
---------------------------------------------------------------------------

    Many commenters discussed the fact that the use of contact lenses 
presents certain eye health risks. Prescribers pointed out that merely 
by wearing contact lenses, patients will experience an increased risk 
for microbial keratitis (also referred to as infectious or bacterial 
keratitis).\39\ Indeed, contact lens wear has been identified as the 
largest single risk factor for microbial keratitis.\40\ Furthermore, 
this risk increases if a patient wears the lenses too long, wears the 
lenses overnight, or fails to comply with the recommended replacement 
schedule.\41\ Other commenters noted that additional risk factors for 
ocular complications include improper care of the lenses or poor 
hygiene practices.\42\ Other commenters pointed out that improperly 
fitting contact lenses may result in corneal ulcers and other health 
issues.\43\
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    \39\ See, e.g., Whipple (Comment #15); Nelson (Comment #130). 
See also CLAO (Comment #572) (commenting that ``[t]he CDC points out 
that the largest single risk factor for microbial keratitis is 
contact lens wear''); Lupinski (Comment #499) (``[s]tudies over the 
years have shown that wearing contact lenses increases the risk for 
ocular health complications'').
    \40\ Cope, supra note 29, at 866.
    \41\ See id. at 867 (``sleeping in any type of contact lens 
increases risk for eye infection''); Fiona Stapleton, et al., ``The 
Incidence of Contact Lens-Related Microbial Keratitis in 
Australia,'' Ophthalmology 2008; 115:1655, 1659 (``Overnight use of 
[contact lenses], irrespective of material type, continues to be the 
main risk factor for corneal infection.''). See also Whipple 
(Comment #15); Buthod (Comment #81); Morgan (Comment #144); Lupinski 
(Comment #499); Bearden (Comment #554).
    \42\ See, e.g., Shlosman (Comment #290); Israel (Comment #429); 
Bearden (Comment #554); Barnett (Comment #668). See also CLAO 
(Comment #572) (citing to a recent CDC report that found outbreaks 
of serious eye infections among contact lens wearers continue and 
``are associated with failure to wear, clean, disinfect and store 
their lenses as directed'').
    \43\ See, e.g., Raykovicz (Comment #35); Morgan (Comment #144); 
Pusz (Comment #646); see also American Academy of Ophthalmology 
(Comment #611) (``[w]earing improper lenses can further complicate 
existing vision issues, including leading to infection in the 
eye'').
---------------------------------------------------------------------------

    In light of the risks associated with the use of contact lenses, 
many commenters--including individual prescribers, optometric and 
ophthalmologic associations, and contact lens manufacturers--stressed 
the important need to adequately protect eye health and safety and 
argued that the current Rule framework is not sufficient to do so.\44\ 
For example, the Contact Lens Association of Ophthalmologists, Inc. 
(``CLAO'') asserted that the Rule's passive verification framework 
``creates a mechanism for renewal of expired prescriptions'' and 
``eliminates a critical opportunity to improve the public health of 
contact lens consumers by addressing risky wear and care practices.'' 
\45\ As support, the CLAO comment cited to an article in the CDC's 
weekly report recommending vigorous health promotion activities to 
encourage contact lens wearers to improve their hygiene behaviors.\46\ 
However, the comment did not include any empirical evidence showing 
that the passive verification mechanism has actually resulted in the 
renewal of expired prescriptions. Furthermore, the CLAO did not present 
any data showing that patients are not visiting their eye care 
practitioners as a result of the passive verification mechanism (or any 
other Rule provision).
---------------------------------------------------------------------------

    \44\ Commenters provided illustrations of how they believe the 
current operation of the Rule is jeopardizing consumer health. For 
example, some commenters posited that loopholes in the Rule allow 
patients to obtain lenses with expired, or otherwise invalid, 
prescriptions. According to this line of argument, patients are 
obtaining lenses without annual eye examinations, or without the 
proper medical oversight to monitor their use of contact lenses, and 
this could result in delayed or missed diagnosis of contact lens-
related eye issues, other eye health issues, or other health 
conditions that otherwise would be detected during an annual eye 
examination. Commenters also expressed concerns that if patients do 
not visit eye care prescribers regularly, they will not receive 
proper training on the care and use of contact lenses.
    \45\ Comment #572. See also American Optometric Association 
(Comment #644) (``[a]llowing repurchases based on long-expired 
prescriptions may be, at the time, convenient for the patient and 
profitable for the seller, but increases the risk of patient 
harm'').
    \46\ Cope, supra note 29.
---------------------------------------------------------------------------

    Other examples of patient harm identified by commenters were either 
hypothetical or anecdotal (such as case reports about the experiences 
of individual patients).\47\ The comments did not include data 
indicating the number or percentage of patients who obtain lenses 
without a valid prescription, or empirical evidence that patients are 
seeing their eye care practitioners less frequently than they did prior 
to the Rule's adoption. In addition, while some commenters stated that 
patients are obtaining lenses without proper medical supervision, 
industry data indicates that approximately 40% of contact lenses are 
still obtained directly from independent prescribers, and only roughly 
16% of contact lenses are obtained from online-only sellers, the retail 
venue most frequently mentioned by commenters.\48\ Most importantly, 
these commenters did not point to any evidence that the implementation 
of the Rule has increased the incidence of contact lens complications.
---------------------------------------------------------------------------

    \47\ See, e.g., Combs (Comment #90) (patient with corneal ulcer 
had not been to doctor in eight years); Simmons (Comment #104) 
(patient ordered contacts using spectacle prescription with on 
online retailer; never given proper hygiene training); Mansito 
(Comment #122) (sister ordered lenses online with expired 
prescription; they did not fit and she needed corneal transplant); 
Ahn (Comment #215) (patient sleeping in lenses for a week at a time, 
using outdated prescription).
    \48\ Vision Council, ``U.S. Optical Industry Report Card,'' Dec. 
2015.
---------------------------------------------------------------------------

    Other commenters argued that contact lens sales through alternative 
supply channels put patients at higher risk for ocular complications. 
The American Academy of Optometry, for example, asserted that ``careful 
peer reviewed research over the past ten years'' shows that ``the 
development of alternative supply chains for the sale of contact 
lenses--and the use of those alternative supply chains by contact lens 
patients--has itself become an identifiable risk factor for ocular 
morbidity in contact lens patients.'' \49\ To support this contention, 
this commenter cited several studies that it believes show that 
internet purchasers of contact lenses are more likely to engage in 
harmful eye care practices,\50\ to have a significant difference in 
aftercare awareness,\51\ and to have a higher risk of developing 
microbial keratitis.\52\ The Commission examined each of these studies 
and concludes that they are not sufficient to reliably demonstrate that 
purchasing lenses online is a risk factor, or that online purchasers 
are at a higher risk of developing microbial keratitis or any other 
ocular complication.\53\
---------------------------------------------------------------------------

    \49\ Comment #623.
    \50\ Joshua Fogel & Chaya Zidile, ``Contact lenses purchased 
over the Internet place individuals potentially at risk for harmful 
eye care practices,'' Optometry, 79.1 (2008) 23-35.
    \51\ Yvonne Wu et al., ``Contact lens user profile, attitudes 
and level of compliance to lens care,'' Cont. Lens Anterior Eye 33 
(2010) 183-188.
    \52\ Stapleton, supra note 41.
    \53\ The Fogel and Wu studies have relatively small samples of 
consumers who purchased contact lenses over the Internet and the 
sample recruiting methodologies call into question whether the 
results are generalizable to the national population. In addition, 
the results of these studies link purchase locations to consumer 
behaviors such as having a doctor check the contact lens fitting 
after purchase or awareness of recommended follow-up visit, rather 
than actual adverse eye health outcomes. The Stapleton study 
identified Internet/mail order purchases as a potential risk factor 
for microbial keratitis in a large sample from Australia. However, 
when the authors of the Stapleton study limit their sample to cases 
of moderate to severe keratitis, Internet/mail order purchases are 
not found to be a risk factor. See Fiona Stapleton et al., ``Risk 
factors for moderate and severe microbial keratitis in daily wear 
contact lens users,'' Ophthalmology 2012; 119:1516-1521.

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[[Page 88530]]

    Some commenters merely asserted that patient eye health is being 
compromised because online retailers do not comply with the Rule,\54\ 
online retailer practices have convinced consumers that contact lenses 
are a commodity rather than a medical device,\55\ and online retailers 
do not provide patients with proper care instructions.\56\ Other 
prescribers alleged that patients who purchase contact lenses online or 
through mail order companies are noncompliant with follow-up eye care 
and the safe use of contact lenses,\57\ or purchase lenses with expired 
prescriptions and then experience complications.\58\ A few commenters 
asserted that online purchasing in particular allows patients to obtain 
lenses without a valid, unexpired prescription and provided anecdotal 
examples of patients who avoided regular eye examinations by purchasing 
lenses online.\59\
---------------------------------------------------------------------------

    \54\ See, e.g., Weissman (Comment #50); Copeland (Comment #73); 
Anderson (Comment #96); Woodland (Comment #98); Wheeden (Comment 
#214); Holliday (Comment #249); Arthur (Comment #371); Blankenship 
(Comment #395).
    \55\ Sancho (Comment #226).
    \56\ Miyabe (Comment #481).
    \57\ See, e.g., Alford (Comment #18) (stating that they have a 
much higher rate of adverse effects such as vision threatening eye 
infections and inflammatory conditions, as they usually over wear 
their lenses and avoid seeking eye care when they have a 
complication).
    \58\ See, e.g., Owen (Comment #72); Stephens (Comment #210); Ahn 
(Comment #215); Born (Comment #570); King (Comment #655).
    \59\ Gronquist (Comment #75); Buthod (Comment #81); Morgan 
(Comment #144); Sadeghian (Comment #242).
---------------------------------------------------------------------------

    The Commission does not find the evidence proffered in this Rule 
review sufficient to support a conclusion that the Rule inadequately 
protects consumer eye health. Commenters did not provide sufficient 
reliable empirical evidence that the current Rule leads to the 
increased acquisition of contact lenses without a valid prescription or 
increased incidence of contact lens-related eye disease or adverse eye 
conditions. Furthermore, despite commenters' concerns about online or 
mail order sales of contact lenses, the Commission has not seen 
reliable empirical evidence to support a finding that such sales are 
contributing to an increased incidence, or increased risk, of contact 
lens-related eye problems.\60\ In addition, the particular risks 
associated with contact lens use (or overuse) were previously 
considered by Congress and the Commission during the passage of the Act 
and the implementation of the Rule.\61\ The current rulemaking record 
does not provide any basis to disrupt this original analysis.
---------------------------------------------------------------------------

    \60\ Several commenters referenced the article published in the 
CDC weekly report (Cope, supra note 29) for the proposition that the 
sale of contact lenses requires stricter oversight because of this 
article's finding that, ``[a]pproximately 99% of wearers reported at 
least one contact lens hygiene risk behavior.'' The Commission notes 
two important caveats. First, the authors reached this number by 
including any wearer that indicated that they had ``ever'' engaged 
in a risk behavior. Hence, the 99% figure includes every wearer, who 
at any time, had engaged in a risk behavior even once. Second, the 
survey instrument asked users where they purchased their lenses, and 
in a separate article, the authors did not conclude that there was 
any difference in either habits or health risks based on whether the 
lenses were purchased from a provider, retail store without an exam, 
or over the internet. See Robin Chalmers et al., ``Is Purchasing 
Lenses from the Prescriber Associated with Better Habits Among Soft 
Contact Lens Wearers?,'' Cont. Lens Anterior Eye 2016 Aug 12 (Epub 
ahead of print) PMID: 27527924.
    \61\ See, e.g., 2004 Possible Barriers to E-Commerce Report, 
supra note 19, at 8-12.
---------------------------------------------------------------------------

III. Availability of Contact Lens Prescriptions to Patients

    Section 315.3 of the Rule provides the framework under which 
prescribers are required to release contact lens prescriptions to 
patients and other authorized third parties. Section 315.3 also imposes 
limitations on the conditions prescribers may require of patients 
before releasing their prescription.

A. Section 315.3(a)(1)--Automatic Prescription Release

    Section 315.3(a)(1) of the Rule requires a prescriber to provide a 
copy of the contact lens prescription to the patient after completing a 
contact lens fitting, regardless of whether it was requested by the 
patient. Section 315.3(a)(1) of the Rule tracks the language of the Act 
verbatim.\62\
---------------------------------------------------------------------------

    \62\ 15 U.S.C. 7601(a)(1).
---------------------------------------------------------------------------

    This provision, referred to as automatic prescription release, was 
intended to empower consumers to comparison shop for contact 
lenses.\63\ Automatic prescription release has been in effect for 12 
years and is now widely supported by commenters, including both 
prescribers \64\ and third-party sellers,\65\ with several recognizing 
it as the ``cornerstone,'' \66\ or ``pillar,'' \67\ of the Act and the 
Rule. Of the 660 comments received by the Commission, none explicitly 
opposed the automatic release provision of the Rule although some 
prescribers asserted that from a safety perspective, it is in patients' 
best interests to purchase contact lenses from their prescribers rather 
than from third-party sellers.\68\ More common, however, were comments 
supporting automatic prescription release, but suggesting that the 
provision was not sufficiently complied with or enforced.\69\ Other 
commenters suggested that the automatic prescription release provision 
should take into account advances in technology.
---------------------------------------------------------------------------

    \63\ Contact Lens Rule, Notice of Proposed Rulemaking, 69 FR 
5440 (Feb. 4, 2004).
    \64\ See, e.g., American Academy of Ophthalmology (Comment #611) 
(``we believe [the Rule] empowers consumers to comparison shop for 
contact lenses''); Coalition for Patient Vision Care Safety (Comment 
#621) (``Since enactment, and the FTC's subsequent implementation, 
the market for contact lenses has become extremely competitive . . . 
This competition has led to increased investment in research and 
development, and a proliferation of innovation that served to 
benefit the nearly 44 million Americans who use contact lenses every 
day.''). See also Carroll (Comment #5); Voight (Comment #551); 
Alianello (Comment #253).
    \65\ See, e.g., 1-800 CONTACTS (Comment #568); Lens.com (Comment 
#614).
    \66\ Warby Parker (Comment #593).
    \67\ Rhode Island State Representative Kennedy (Comment #536); 
1-800 CONTACTS (Comment #568); see also Utah State Senator Bramble 
(Comment #576); National Association of Optometrists and Opticians 
(Comment #549); Utah Retail Merchants Association (Comment #28).
    \68\ See, e.g., Woo (Comment #56).
    \69\ See, e.g., 1-800 CONTACTS (Comment #568); Lens.com (Comment 
#614); Utah State Senator Bramble (Comment #576).
---------------------------------------------------------------------------

1. Compliance With the Automatic Prescription Release Requirement
    Several commenters stated that prescribers routinely fail to comply 
with the automatic prescription release requirement: Some do not--or do 
not always--provide a prescription unless a consumer explicitly 
requests it; some do not provide complete prescriptions, as required by 
the Rule; and some do not provide prescriptions at all.\70\ These 
comments are, in general, concordant with complaints the Commission has 
received from numerous consumers apart from this rule review 
process.\71\ Some consumer complaints, however, may be based on a 
misunderstanding of the Rule, as there can be confusion

[[Page 88531]]

about when or under what conditions patients should receive their 
prescriptions. For example, the Rule requires that a prescription be 
provided after the completion of the contact lens fitting, not 
necessarily at the conclusion of the initial visit with the prescriber. 
Because a fitting may not be complete until a follow-up visit, a 
patient might incorrectly believe that she should have been provided 
with her prescription at the conclusion of the first visit.
---------------------------------------------------------------------------

    \70\ See, e.g., Consumers Union (Comment #677); Rhode Island 
State Representative Kennedy (Comment #536); Lens.com (Comment 
#614).
    \71\ They are also consistent with longstanding practices of eye 
care professionals prior to enactment of the Fairness to Contact 
Lens Consumers Act, even in states where prescribers were required, 
by state statute, to release prescriptions to consumers. 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) (Testimony of Ami Gadhia, Consumers Union).
---------------------------------------------------------------------------

    A number of prescribers commented, to the contrary, that they 
always provide contact lens prescriptions to their patients, and 
believe that others in their profession do so as well.\72\ Prescribers, 
for their part, may be aware in a general way of their obligation to 
release prescriptions and yet be unaware of all of the conditions of 
prescription release required by the Rule. Hence, they might be 
mistaken in assessing, and reporting on, their own compliance.
---------------------------------------------------------------------------

    \72\ Howe (Comment #53). See also, e.g., Galdamez (Comment 
#167); Ahn (Comment #215).
---------------------------------------------------------------------------

    Many reports of compliance and noncompliance are anecdotal, and 
robust empirical data are sparse. Although the Commission would prefer 
better empirical evidence about compliance and noncompliance with the 
Rule, and about the effects of the Rule, some survey evidence has been 
submitted by sellers, prescribers, and manufacturers. The Commission 
considers these submissions to be suggestive and, to an extent, 
informative, but none can be regarded as definitive. It is important to 
note, at the outset, that all of these surveys are subject to 
particular methodological limitations, as well as limits commonly 
associated with survey evidence. For example, patients may sometimes 
misremember the details of any particular prior encounter with a 
prescriber; prescribers, for their part, may be mistaken about the 
particulars of a given clinical encounter, about the frequency with 
which they do or do not release prescriptions, or about the frequency 
or severity of problems they may encounter in verifying prescriptions. 
For the most part, the surveys do not include independent, objective 
tests of patient or prescriber recollections. In addition, survey 
responses may be sensitive to the ways in which survey questions are 
framed.
    As part of its comment, 1-800 CONTACTS, the country's largest 
online seller of contact lenses, submitted a survey conducted on its 
behalf by a third-party research firm, Survey Sampling International. 
That survey found that only 35% of contact lens wearers reported 
receiving a copy of their prescription without having to ask for 
it.\73\ Another 28% reported receiving their prescription upon request 
(either at the office or afterwards), while 36% said they never 
received it at all.\74\ Additional, and similarly-designed surveys, 
conducted on behalf of 1-800 CONTACTS in November 2014 and May 2015 
found that 45% and 48% of contact lens wearers, respectively, reported 
that they were automatically given a hard copy of their prescription at 
their last eye exam.\75\
---------------------------------------------------------------------------

    \73\ 1-800 CONTACTS (Comment #568), Exhibit B. According to 1-
800 CONTACTS, the data derives from an online survey of 500 contact 
lens wearers ages 18-49 years old by Survey Sampling International 
between Oct. 1 and Oct. 6, 2015. The respondents were not informed 
of the identity of the survey sponsor. The Commission has concerns 
about the methodology utilized for this survey, particularly about 
the lack of an ``I don't know'' option for various questions, but 
believes the information may still be suggestive, particularly when 
viewed in conjunction with information from other sources and the 
absence of contradictory data.
    \74\ Id. at 3.
    \75\ 1-800 CONTACTS (Comment #568), Exhibit C. According to 1-
800 CONTACTS, these data are based on two surveys of 2000 contact 
lens wearers, randomly selected and conducted in November 2014 and 
May 2015. These surveys were sponsored by 1-800 CONTACTS and 
conducted by an independent market research company. As with the 
2015 survey cited above, the Commission has concerns about the 
methodology utilized for these surveys but believes the information 
may still be suggestive, particularly when viewed in conjunction 
with information from other sources and the absence of contradictory 
data.
---------------------------------------------------------------------------

    Some commenters also cited a 2008 report in a contact lens industry 
publication which found that just half of surveyed optometrists 
replied, ``yes, to every patient,'' when asked if they routinely 
release contact lens prescriptions.\76\
---------------------------------------------------------------------------

    \76\ 1-800 CONTACTS (Comment #568), Information Technology & 
Innovation Foundation (Comment #40), Utah Retail Merchants 
Association (Comment #28) citing Mack, supra note 34. Analogously, 
an October 2015 SurveyMonkey survey of 1,329 respondents, sponsored 
by online eyewear seller Warby Parker, reported that 47% of 
consumers who saw optometrists were not automatically provided with 
an eyeglass prescription at the end of the exam. Warby Parker 
(Comment #813 on the Ophthalmic Practice Rules), https://www.ftc.gov/policy/public-comments/initiative-624. The patients 
surveyed by SurveyMonkey were primarily consumers who purchased 
eyeglasses, not contact lenses, but the prescription-release 
requirement for eyeglass prescriptions is similar to that for 
contact lenses and both eyeglasses and contact lenses are prescribed 
by the same categories of eye care professionals. See Ophthalmic 
Practice Rules, 16 CFR 456.2.
---------------------------------------------------------------------------

    Other commenters stated that even when consumers receive a copy of 
their prescription, the prescription information is not always complete 
or correct. One online seller of replacement lenses contended that some 
prescribers deliberately render prescriptions incomplete by omitting 
information, in order to make it more difficult for consumers to buy 
lenses from third-party sellers.\77\ According to an internal review of 
prescriptions on file with 1-800 CONTACTS, 23% were missing one or more 
parameters required to fill an order, and 43% lacked complete contact 
information for the prescriber.\78\
---------------------------------------------------------------------------

    \77\ LD Vision Group (Comment #544).
    \78\ 1-800 CONTACTS (Comment #568) (based on a ``sample of 803 
prescriptions on file with 1-800 CONTACTS.''). The Commission was 
not provided with the data for this sample, and so cannot judge 
whether the data are generalizable. Apart from this internal survey, 
the Commission has not received other empirical evidence 
demonstrating that prescribers--deliberately or otherwise--failed to 
provide patients with complete prescriptions.
---------------------------------------------------------------------------

    Such omissions, when they occur, may be intentional, may reflect 
clerical or communication errors, or may reflect an imperfect 
understanding of the Rule's complete requirements for prescription 
release. All such errors could reflect failures to comply fully with 
the requirements of the Rule.
    The sheer number of verifications conducted by third-party sellers 
also may suggest that many consumers are not automatically receiving 
their prescriptions from prescribers, or are not receiving complete 
prescriptions. Under Section 315.5, verifications are only necessary if 
a consumer fails to provide a third-party seller with a complete 
prescription. According to discussions with industry, roughly three-
quarters of third-party contact lens sales require prescription 
verification, meaning that the consumer did not present a complete 
prescription at the time of the attempted purchase. Seemingly contrary 
to this data is a survey, conducted on behalf of Johnson & Johnson 
Vision Care, Inc., a large contact lens manufacturer, according to 
which 61% of consumer respondents said that they provided the retailer 
with their prescription the last time they purchased lenses online or 
by telephone.\79\ The Commission does not have enough data or insight 
to determine if either of these surveys accurately reflects industry 
practice. It is possible that some of these consumers received 
incomplete or otherwise problematic prescriptions. If so, those 
consumers might accurately report that they provided something that 
they believed to be a prescription at the time of purchase when, in 
fact, the document they provided was not complete or fillable, and 
hence (a) required verification and (b) was not a ``prescription'' as 
defined by the Rule. Alternatively, some consumers could have received 
their prescriptions from

[[Page 88532]]

prescribers but misplaced them, forgot them, or simply thought it 
easier to obtain the refraction information from their contact lens 
boxes. Whatever the frequency with which each of these possibilities 
occurs, it is evident that third-party sellers are presently verifying 
a significant percentage of contact lens prescriptions with 
prescribers. It is also evident, based on the comments submitted, that 
many prescribers feel there are too many verification requests, and 
that it would be helpful if more patients provided a copy of their 
prescription to sellers rather than rely on the verification 
process.\80\
---------------------------------------------------------------------------

    \79\ Johnson & Johnson Vision Care, Inc. (Comment #582) (August 
2015 telephone survey by APCO Insight for J&J).
    \80\ See, e.g., Carroll (Comment #5) (``[Verification] is costly 
to my business. the patient should have a written copy of their Rx 
to provide to the vendor of their choice.''); Walton (Comment #543) 
(``It should be the consumer's responsibility to provide the seller 
a full, unexpired contact lens prescription and the doctor 
prescribing should not have to be involved in this process. It puts 
undue stress on small local businesses to have to respond to 
faxes''); Baur (Comment #170) (``If I am already handing patients a 
copy of their prescription, why do I have to verify the Rx at 
all?'').
---------------------------------------------------------------------------

    Another concern raised by commenters is whether consumers are even 
fully aware of their right to their prescriptions.\81\ According to the 
aforementioned October 2015 survey conducted on behalf of 1-800 
CONTACTS, 46% of contact lens wearers were unaware that they had a 
right to receive a copy of their prescription, even though the Rule has 
been in effect since 2004.\82\ The manner in which this particular 
question was phrased in the 1-800 survey,\83\ however, raises 
Commission concerns about the validity of, or the weight that should be 
accorded to, the results for this question. In particular, the question 
is leading, it lacks an ``I don't know'' option, it uses a term--``hard 
copy''--which some patients may not understand, and it is phrased in 
such a way that it could give rise to social desirability bias,\84\ 
since respondents might be reluctant to admit that they are unaware of 
their rights under federal law. That being said, a response error 
resulting from social desirability bias in this instance would more 
likely lead to undercounting, or underestimation, of the number of 
patients who are unaware they have a right to their prescription. In 
other words, the way the question was phrased could make it seem that 
more patients are aware of their right than is actually the case, and 
it is thus possible that more than 46% of contact lens wearers are 
unaware that they have a right to automatically receive their 
prescription at the end of their contact lens fitting.
---------------------------------------------------------------------------

    \81\ Warby Parker (Comment #593); 1-800 CONTACTS (Comment #568).
    \82\ 1-800 CONTACTS (Comment #568), Exhibit B.
    \83\ The question was phrased as follows: ``Are you aware that 
it is your right under federal law, as a patient to receive a hard 
copy of your contact lens prescription from your eye exam 
provider?,'' with the only possible answers being Yes or No.
    \84\ Social desirability bias is the tendency of survey 
respondents to answer questions in a manner that will be viewed 
favorably by others.
---------------------------------------------------------------------------

2. Commenter Suggestions for Improving Automatic Prescription Release 
Compliance
    Some commenters asked the Commission to take specific actions to 
increase compliance with the automatic prescription release 
requirement.\85\ Some commenters recommended that the Commission 
increase the number of enforcement actions it takes against prescribers 
who fail to comply with automatic prescription release in order to 
``send a message to complacent prescribers.'' \86\ Another suggestion, 
put forth by 1-800 CONTACTS and other third-party sellers, is to amend 
the Rule to require that, immediately upon completing a contact lens 
fitting, prescribers provide patients with an eye care patients' ``Bill 
of Rights,'' informing them of their right to their prescription, that 
the prescription will be provided without request, and that they have a 
right to purchase lenses from the seller of their choice.\87\ Another 
commenter, Consumers Union, the policy and advocacy division of 
Consumer Reports, suggested that prescribers inform consumers at the 
beginning of their visit--as part of the initial paperwork--that they 
will provide a prescription at the end of the examination at no 
additional cost.\88\
---------------------------------------------------------------------------

    \85\ See, e.g., 1-800 CONTACTS (Comment #568); Utah Retail 
Merchants Association (Comment #28); Utah State Senator Bramble 
(Comment #576); Information Technology & Information Foundation 
(Comment #40); Lens.com (Comment #614); Warby Parker (Comment #593).
    \86\ 1-800 CONTACTS (Comment #568). See also Utah State Senator 
Bramble (Comment #576); Utah Retail Merchants Association (Comment 
#28).
    \87\ 1-800 CONTACTS (Comment #568). See also Warby Parker 
(Comment #593); Lens.com (Comment #614).
    \88\ Consumers Union (Comment #677).
---------------------------------------------------------------------------

    Other commenters suggested requiring patients to sign an 
``Acknowledgment of Release'' document, confirming that they received 
their prescriptions.\89\ Prescribers would be required to retain the 
signed acknowledgments, which then could be inspected by the Commission 
to verify compliance.\90\ One commenter, an Arizona state 
representative, said she was considering introducing state legislation 
that would mandate such signed acknowledgments for prescribers in her 
state.\91\
---------------------------------------------------------------------------

    \89\ Lens.com (Comment #614); 1-800 CONTACTS (Comment #568). See 
also Arizona State Representative Carter (Comment #545).
    \90\ Id.
    \91\ Arizona State Representative Carter (Comment #545).
---------------------------------------------------------------------------

3. Analysis of Proposals for Improving Automatic Prescription Release 
Compliance and Commission Proposal
    Having considered the various comments and suggestions, the 
Commission believes that improving compliance with automatic 
prescription release would further the goals of the Act. While none of 
the five surveys \92\ cited by commenters are definitive on the 
question of automatic release compliance, the Commission believes that 
the overall weight of evidence in the rulemaking record--including the 
surveys, the high number of verifications, the ongoing pattern of 
consumer complaints and anecdotal reports, and the industry's long 
history of failing to provide prescriptions to patients even when 
obligated by state law--indicates that compliance with the automatic 
prescription release provision could be substantially improved. 
Furthermore, the potential benefits of increasing the number of 
patients who receive their prescriptions are substantial: Increased 
patient flexibility and choice in shopping for contact lenses; a 
reduced number of verification requests, which some prescribers find 
burdensome; a reduced likelihood of errors associated with incomplete 
prescriptions; and a reduction in the number and complications of 
failed attempts at verification. Increasing compliance also is likely 
to spur more competition and innovation among contact lens sellers and 
manufacturers. It should also reduce the number of attempts by sellers 
to verify expired or inaccurate prescriptions, as well as attempts to 
verify prescriptions with the wrong prescriber, practices that many 
prescribers complained about in their comments.\93\ The cumulative 
effect of increased compliance would likely be lower costs and improved 
convenience and flexibility for patients, sellers, and prescribers as 
well as increased accuracy of prescriptions presented to sellers, 
thereby reducing potential consumer harm from inaccurate, expired, or 
otherwise invalid prescriptions.\94\
---------------------------------------------------------------------------

    \92\ See supra notes 73-76, citing surveys by Survey Sampling 
International, Contact Lens Spectrum, and SurveyMonkey.
    \93\ See infra Section IV.
    \94\ See, e.g., Lens.com (Comment #614) (predicting that 
improving automatic prescription release compliance could lead to 
lower contact lens prices, since it would reduce verification costs 
for both sellers and prescribers).
---------------------------------------------------------------------------

    Having determined that it would be beneficial to increase 
compliance with

[[Page 88533]]

the automatic prescription release provision, the Commission now 
evaluates various proposals put forth by commenters for how to best 
achieve this goal.
(a) Proposal To Increase Enforcement
    Several commenters suggested that one way to better ensure 
automatic prescription release compliance is for the Commission to 
become more aggressive about enforcement.\95\ According to 1-800 
CONTACTS, ``Prescribers today clearly believe they can disregard their 
legal obligations without consequence.'' \96\ 1-800 CONTACTS urged the 
Commission to regularly investigate prescriber practices and issue 
warning letters or take enforcement actions against prescribers that do 
not comply with the automatic prescription release provision.\97\ 
According to 1-800 CONTACTS, this would not only change the behavior of 
the targeted prescribers, but would send a signal to other prescribers 
that they need to comply with the Rule.
---------------------------------------------------------------------------

    \95\ 1-800 CONTACTS (Comment #568). See also Utah State Senator 
Bramble (Comment #576); Utah Retail Merchants Association (Comment 
#28).
    \96\ 1-800 CONTACTS (Comment #568).
    \97\ Id. at 25-26.
---------------------------------------------------------------------------

    The Commission recognizes the need for increased enforcement of the 
automatic prescription release provision and already has taken some 
recent steps to achieve better compliance. For example, in April 2016, 
the Commission sent warning letters to 45 contact lens prescribers 
after receiving consumer complaints alleging that the prescribers had 
violated the Rule, often by failing to provide patients with their 
prescriptions automatically.\98\ The Commission acknowledges, however, 
that the absence of documentation makes it difficult to determine 
whether a prescriber did or did not provide a patient with a 
prescription as required, in any particular case. The absence of 
documentation also makes it difficult to determine how many times, or 
how frequently, a noncompliant party has violated the Rule. Instead, 
allegations and denials of Rule violations might often become a matter 
of the patient's word against that of the prescriber, making accurate 
enforcement decisions, as well as enforcement actions predicated on 
those decisions (as opposed to warning letters) more challenging. The 
Commission thus believes that enforcement could improve through a 
mechanism to increase its ability to assess and verify compliance with 
the Rule's automatic prescription release requirements.
---------------------------------------------------------------------------

    \98\ Press Release, Fed.Tr. Comm'n, FTC Issues Warning Letters 
Regarding the Agency's Contact Lens Rule (Apr. 7, 2016), https://www.ftc.gov/news-events/press-releases/2016/04/ftc-issues-warning-letters-regarding-agencys-contact-lens-rule.
---------------------------------------------------------------------------

(b) Proposal To Require an Eye Care Patients' Bill of Rights or Notice-
Upon-Check-In
    A number of commenters recommended that the Commission amend the 
Rule to require that prescribers provide patients with written notices 
informing them of their right to their prescription. One suggestion, 
proposed by three online sellers of eye wear, is that, immediately upon 
completion of a contact lens fitting, prescribers provide patients with 
a ``Bill of Rights''; that is, a written notice informing patients of 
their rights under the Rule, including: (1) The right to receive their 
prescriptions; (a) provided promptly and automatically without their 
having to request them; (b) at no additional charge; and (2) the right 
to purchase their lenses from the seller of their choice.\99\ Another 
suggestion, put forth by a consumers' rights organization, is that the 
Rule require that, ``the eye doctor inform the consumer at the 
beginning of the visit, as part of the initial paperwork, that the 
prescription will be provided at the conclusion of the visit at no 
additional cost.'' \100\
---------------------------------------------------------------------------

    \99\ 1-800 CONTACTS (Comment #568). See also Warby Parker 
(Comment #593); Lens.com (Comment #614).
    \100\ Consumers Union (Comment #677).
---------------------------------------------------------------------------

    Either of these proposals, if implemented and complied with, would 
notify consumers of their rights and, presumably, would increase the 
percentage of patients who receive prescriptions from their 
prescribers. Providing the required document would remind prescribers 
and their staffs to provide patients with their prescriptions, and it 
would remind patients to ask for their prescriptions in the event that 
the prescriber might fail to provide them initially and without a 
request, as the Rule and the Act already require.
    Since the Commission could draft the specific language for either 
the ``Bill of Rights'' or check-in notice, it could ensure that the 
notice conveys an accurate explanation of the Rule's automatic 
prescription release requirements, something prescribers sometimes fail 
to do.\101\ The requirement should also impose a relatively small 
burden upon prescribers, since prescribers would only need to provide a 
brief, standard form for each patient.
---------------------------------------------------------------------------

    \101\ Imprecise word selection by prescribers may, in some 
cases, lead prescribers to inadvertently violate the rule. For 
example, an eye care practitioner may believe he is complying by 
asking patients, ``Do you want a copy of your prescription?'' when, 
in fact, such a question is a violation of the automatic release 
provision since the prescription is not provided automatically but 
rather requires patients to confirm that they want it. This, in 
turn, may put patients in an awkward position since they may feel 
they are going behind the prescriber's back by shopping for contacts 
elsewhere.
---------------------------------------------------------------------------

    On the other hand, patients already receive forms and other 
paperwork when they visit a prescriber, increasing the possibility that 
patients might not read or attend to the information in the ``Bill of 
Rights'' or check-in notice.
    Moreover, the Rule already requires that prescribers provide 
patients with copies of their prescriptions, yet diverse complaints 
have alleged that many prescribers do not do so. It is at least 
possible that many prescribers who now fail to comply with the Rule's 
prescription release requirements would also fail to comply with a 
requirement to provide a patients' ``Bill of Rights'' or check-in 
notice form. Without some mechanism to ensure compliance, a notice by 
itself might not provide substantial benefits. The notices recommended 
by these proposals would not require the type of prescriber record-
keeping needed to assist the Commission in better Rule enforcement, 
either in its current form or as it might be amended. It is thus 
possible that adding this requirement would impose an increased burden 
on prescribers without providing many tangible, countervailing benefits 
to consumers. In light of these considerations, the Commission has 
determined not to propose to amend the Rule to require either a Bill of 
Rights or notice-upon-check-in.
(c) Proposal To Require a Signed Acknowledgment Form
    Another amendment recommended by some commenters is to require that 
prescribers present, and patients sign, an ``acknowledgment of 
release,'' confirming that they received their prescription at the end 
of their contact lens fitting.\102\ Such an acknowledgment would be a 
separate, stand-alone document, and prescribers would be required to 
retain the signed acknowledgments.\103\
---------------------------------------------------------------------------

    \102\ Lens.com (Comment #614); 1-800 CONTACTS (Comment #568). 
See also Arizona State Representative Carter (Comment #545).
    \103\ Id.
---------------------------------------------------------------------------

    An acknowledgment of release would notify consumers of their 
prescription portability rights and, in all likelihood, increase the 
percentage of patients who receive their prescription from the 
prescriber. Providing the required form would also serve as a reminder 
to

[[Page 88534]]

prescribers and their staffs to provide patients with their 
prescriptions, and serve as a reminder to patients to ask for their 
prescription in the event that they receive the acknowledgment form but 
not the prescription. Once it becomes an established practice, an 
acknowledgment form might also reduce confusion for patients as to when 
their contact lens fitting is actually complete, thus reducing the 
likelihood of erroneous complaints about a prescriber's perceived 
failure to provide a prescription after the completion of a preliminary 
examination but when the contact lens fitting has not yet been 
completed.
    Additionally, since patients would have to affirmatively sign such 
an acknowledgment, it is less likely that such a document would go 
unnoticed or unread by patients than a ``Bill of Rights'' or notice-
upon-check-in type of document. And perhaps most importantly, requiring 
prescribers to retain a signed acknowledgment form would improve the 
Commission's ability to verify whether prescribers had complied with 
this requirement and had met their obligation to release prescriptions 
to their patients. Being able to determine more accurately whether a 
particular prescriber had provided a prescription in a particular case 
would reduce the number of instances where a filed complaint simply 
pits the patient's word against that of the prescriber. It would also 
enable the Commission to evaluate the overall rate at which both 
individual prescribers and the population of prescribers comply with 
the requirement.
    One potential drawback to requiring a signed acknowledgment 
requirement is the increased recordkeeping burden imposed on 
prescribers, since they would have to provide the forms and retain the 
signed acknowledgments for a certain period of time.\104\ This 
recordkeeping burden could be reduced to the extent that prescribers 
have adopted electronic medical record systems, especially those where 
patient signatures can be recorded electronically and input 
automatically into the electronic record. Furthermore, prescribers also 
could scan signed paper copies of the acknowledgment form and store 
those forms electronically to lower the costs of this recordkeeping 
requirement. Accordingly, the Commission believes that any 
recordkeeping burden would be relatively minimal and outweighed by the 
benefit of having more patients in possession of their prescriptions.
---------------------------------------------------------------------------

    \104\ 1-800 CONTACTS suggested that prescribers should maintain 
records of acknowledgments for three years or the length of the 
prescription, whichever is longer. 1-800 CONTACTS (Comment #568).
---------------------------------------------------------------------------

(d) Proposal To Require Signage
    Another possible Rule revision is to require that prescribers' 
offices post conspicuous signage informing consumers of their right to 
their prescription. Although this was not specifically suggested by 
commenters,\105\ it is currently required by law in California, and the 
practice could be expanded via the Rule to apply nationwide.
---------------------------------------------------------------------------

    \105\ It was cited in the National Association of Optometrists 
and Opticians comment, but not expressly recommended. Comment #549.
---------------------------------------------------------------------------

    In California, the Business and Professional Code provides that 
each prescriber office must post, in a conspicuous place, a notice 
informing patients that eye doctors are required to provide patients 
with a copy of their ophthalmic lens prescriptions. The notice also 
explains that spectacle prescriptions are released upon the completion 
of the exam, and contact lens prescriptions are released upon the 
completion of the exam or upon the completion of the fitting 
process.\106\
---------------------------------------------------------------------------

    \106\ 16 CCR Sec.  1566. California also has an additional state 
law, CAL Bus. & Prof. Code Sec.  2554, which essentially requires 
the same signage, with the addition of a notice stating, ``Patients 
may take their prescription to any eye doctor or registered 
dispensing optician to be filled,'' and requiring the inclusion of 
complaint contact information for the California Board of Optometry.
---------------------------------------------------------------------------

    Such a requirement, if adopted in the Rule, could provide some of 
the same benefits of the Bill of Rights, notice-upon-check-in, and 
signed acknowledgment proposals in that it would, in theory, notify 
consumers of their rights and, presumably, increase the percentage of 
patients who receive their prescription from the prescriber. A sign 
could also serve as a reminder to patients to ask for their 
prescription in the event the prescriber does not provide it. 
Furthermore, a sign would impose less of a burden on prescribers than 
the other proposals, since it would only have to be posted once, as 
opposed to individual copies for each and every patient. Lastly, 
enforcing such a provision would be relatively straightforward, since 
the Commission could perform spot checks on prescribers' offices to 
ensure they have posted the required signage.
    On the other hand, the Commission lacks good evidence about the 
effects of California's particular version of this requirement, and it 
is unclear how many patients actually read posted notices at doctors' 
offices, particularly in locations where there are already numerous ads 
or other postings about various rights, requirements, and obligations. 
It is likely that far fewer patients would learn of their rights from a 
single sign--competing for attention with ads and other signage--than 
from being handed or shown a document, particularly a document 
consumers are required to sign. Moreover, since a sign would not 
require a prescriber to interact with each patient, it would serve as 
less of a reminder to prescribers and their staff to provide patients 
with their prescriptions. And, although it would be relatively 
straightforward for the Commission to verify and enforce the signage 
requirement, such a requirement would do little to assist the 
Commission in verifying or enforcing compliance with the automatic 
prescription release provision itself. Furthermore, Commission staff 
would have to physically visit prescribers' offices located throughout 
the country to verify the signage, resulting in the expenditure of more 
Commission resources to monitor compliance.
(e) The Commission's Proposal To Require a Signed Acknowledgment
    After consideration of the comments and proposals, the Commission 
proposes to add a signed acknowledgment requirement. The Commission 
believes such a provision will help inform patients of their right to 
their prescriptions, increase the number of patients who receive their 
prescriptions and, consequently, increase the number of purchases made 
with initial presentations of complete and valid prescriptions, thus 
reducing the number of verifications by third-party sellers. The 
addition of a signed acknowledgment requirement accomplishes the 
desired objectives with little increased burden on prescribers. The 
Commission believes that implementation of signed acknowledgments would 
best serve several important objectives: Reminding prescribers to 
release prescriptions, informing patients of their rights, reducing 
misunderstandings, and improving the Commission's verification and 
enforcement ability.
    The requirement that the prescriber request the patient acknowledge 
receipt of the contact lens prescription is triggered once the 
prescriber has presented the prescription to the patient. The patient 
shall receive the prescription prior to being asked to sign the 
acknowledgment form, and signing the acknowledgment form is not a 
condition to obtain the prescription. If the patient refuses to sign or 
cannot sign the acknowledgment form, the prescriber must note the 
refusal or

[[Page 88535]]

inability on the acknowledgment form and must maintain the form.
    The acknowledgment form may be either paper or in electronic 
format. The acknowledgment form, whether paper or electronic, must be 
entitled ``Patient Receipt of Contact Lens Prescription,'' and must 
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.'' The acknowledgment form shall be in a format that allows 
either conventional or electronic signatures. Prescribers may maintain 
copies of the acknowledgment forms in paper or electronically.
    The Commission, therefore, proposes to amend Section 315.3 to add 
the requirement that upon completion of a contact lens fitting, and 
after providing a copy of the contact lens prescription to the patient, 
the prescriber shall request that the contact lens patient acknowledge 
receipt of the contact lens prescription by signing an acknowledgment 
form entitled, ``Patient Receipt of Contact Lens Prescription.'' This 
form must state, ``My eye care professional provided me with a copy of 
my contact lens prescription at the completion of my contact lens 
fitting. I understand I am free to purchase contact lenses from the 
seller of my choice.'' In addition, the form must also include the name 
of the patient, the patient signature, and the date the form was 
signed. In the event that the patient declines to sign the 
acknowledgment form, the prescriber shall note the patient's refusal on 
the form and sign it. No other statements or information, other than 
the address or letterhead of the prescriber, shall be placed on the 
acknowledgment form.
    The Commission also proposes to amend Section 315.3 to add the 
requirement that prescribers maintain the signed acknowledgments for a 
period of not less than three years, so that the signed acknowledgments 
are available for inspection by the Federal Trade Commission. The full 
text of the proposed Rule amendment is located in Section X of this 
notice.
4. Additional Mechanisms for Improving Prescription Portability
    The increasing number of prescribers who offer patient ``portals'' 
accessible via the Internet has made it possible for prescribers to 
post, and patients to obtain, prescriptions online, while maintaining 
the security and privacy of patients' health information.\107\ This, 
along with the patient's ability to email prescription copies to 
sellers, increases prescription portability. It also could reduce the 
verification burden on prescribers, to the extent that patients could 
quickly and reliably obtain complete and accurate copies of their 
prescriptions,\108\ without making specific requests to their 
prescribers for such copies, and to the extent that such prescriptions 
could be filled without the seller intervening to verify the 
prescriptions directly with the prescribers. In addition, patient 
portals do not raise the same concerns expressed by some prescribers 
about sharing patient prescription information with third parties, 
because patient portals enable the secure sharing of such information 
directly with the patients themselves.\109\
---------------------------------------------------------------------------

    \107\ Although the Commission lacks data on the use of patient 
portals by ophthalmologists or optometrists in particular, the 
Commission notes that a recent report to Congress observes that 
increasing numbers of physicians and other types of health care 
providers are sharing information electronically with their 
patients. For example, in 2014, four in 10 office-based physicians 
reported sharing information electronically with their patients, and 
57% of all physicians reported sharing information directly with 
their patients electronically. U.S. Dep't Health & Human Servs., 
Office of the National Coordinator for Health Information 
Technology, Report to Congress, ``Update on the Adoption of Health 
Information Technology and Related Efforts to Facilitate the 
Electronic Use and Exchange of Health Information'' 28-30 (2016), 
https://www.healthit.gov/sites/default/files/Attachment_1_-_2-26-16_RTC_Health_IT_Progress.pdf.
    \108\ Empirical studies of the integrity of electronic 
transmission of prescription information chiefly focus on systems 
for transmitting prescription drug information and not contact lens 
prescriptions. Still, such studies suggest that the adoption of 
electronic prescribing greatly reduces the error rate associated 
with handwritten paper prescriptions. See, e.g., Rainu Kaushal et 
al., ``Electronic Prescribing Improves Medication Safety in 
Community-Based Office Practices,'' 25 J. Gen. Intern. Med. 530, 530 
(2010) (finding that, ``For e-prescribing adopters, error rates 
decreased nearly sevenfold, from 42.5 per 100 prescriptions (95% 
confidence interval (``CI''), 36.7-49.3) at baseline to 6.6 per 100 
prescriptions (95% CI, 5.1-8.3) one year after adoption (p<0.001). 
For non-adopters, error rates remained high at 37.3 per 100 
prescriptions.'').
    \109\ See, e.g., U.S. Dep't Health & Human Servs., HealthIT.gov, 
``Do I Need to Obtain Consent From My Patients to Implement a 
Patient Portal?,'' https://www.healthit.gov/providers-professionals/faqs/do-i-need-obtain-consent-my-patients-implement-patient-portal 
(noting that HIPAA permits the disclosure of health information to 
the patient without requiring the patient's express consent and that 
portals are ``an excellent way to afford patients access to their 
own information and to encourage them to be active partners in their 
health care.'')
---------------------------------------------------------------------------

    Accordingly, the Commission believes that the use of patient 
portals to provide patients with access to electronic copies of their 
prescriptions can benefit prescribers, sellers, and patients. The 
Commission encourages prescribers, in addition to providing patients 
with a copy of their prescriptions, to make prescriptions available via 
patient portals in accordance with federal and state law, including HHS 
guidance. Uploading prescriptions to patient portals will make it 
easier for patients to access their prescriptions and, consequently, to 
transmit them to sellers when purchasing lenses. This, in turn, may 
substantially increase the accuracy of seller-filled orders and reduce 
the verification burden on prescribers.\110\ To facilitate the 
likelihood that patient portals will increase prescription portability, 
the patient portal should be configured to allow the patient to 
download, save, and print the prescription, as well as to allow the 
patient to email, or otherwise transmit, prescriptions directly to a 
seller.
---------------------------------------------------------------------------

    \110\ See Kaushal, supra note 108.
---------------------------------------------------------------------------

    At this time, the Commission does not have enough information to 
determine whether solely posting a contact lens prescription to a 
patient portal is sufficient to satisfy the Rule's obligation for 
prescribers to provide copies of contact lens prescriptions to 
patients. However, the Commission seeks comment on the use and adoption 
of patient portals, as well as the potential ability for such 
technology to allow prescribers to comply with the automatic 
prescription release requirement of the Rule.

B. Section 315.3(a)(1)--Additional Copies of Prescriptions

    Some commenters requested that the Commission amend the Rule to 
expressly obligate prescribers to provide duplicate prescription copies 
to patients upon request.\111\ According to Consumers Union, such a 
requirement would provide ``additional protection for situations in 
which the eye doctor neglects to provide the prescription during the 
visit, as well as for situations in which the prescription is misplaced 
by the consumer.'' \112\ Likewise, the health and safety organization 
Prevent Blindness asserted that duplicate copies should be available 
upon request since ``[i]t is a basic consumer right to own one's 
prescriptions.'' \113\
---------------------------------------------------------------------------

    \111\ Prevent Blindness (Comment #13); Consumers Union (Comment 
#677).
    \112\ Consumers Union (Comment #677).
    \113\ Prevent Blindness (Comment #13).
---------------------------------------------------------------------------

    During the initial rulemaking, the Commission stated that the Act 
neither requires prescribers to release, nor prohibits them from 
releasing, additional copies of the prescription.\114\ At that time, 
the Commission declined

[[Page 88536]]

to require or prohibit the release of additional copies of the 
prescription.\115\
---------------------------------------------------------------------------

    \114\ 69 FR at 40492.
    \115\ Id.
---------------------------------------------------------------------------

    Upon consideration of the comments, the rulemaking record, and a 
re-examination of the language of the Act itself, the Commission now 
clarifies that the Act and the Rule require that prescribers provide 
patients with additional copies of their prescriptions upon request. 
Accordingly, the Commission believes there is no need to amend the 
Rule, but seeks comment on this clarification.
    This determination is supported by a number of considerations. 
First, as noted above, during the initial rulemaking, the Commission 
stated that the Act neither requires nor prohibits additional copies of 
the prescription. However, this statement was made in response to two 
commenters who recommended that the prescription release obligation be 
limited to one release per patient. Thus, the Commission did not fully 
consider whether additional copies should be required, only that the 
Act did not expressly limit patients to one copy.
    Second, the Act and the Rule require that prescribers provide or 
verify the patient's prescription when so ``directed by any person 
designated to act on behalf of the patient.'' \116\ This provision has 
been interpreted to mean that prescribers must provide a prescription 
whenever a patient authorizes an agent to request one, even if the 
patient previously received a prescription copy from the 
prescriber.\117\ The Commission's Division of Advertising Practices, 
which administers and enforces the Rule, arrived at this interpretation 
based upon the plain language of the Act and Rule, as well as upon 
recognition that when consumers want to order contact lenses, ``some 
consumers have neither their prescription nor sufficient information 
about their prescription for [the seller] to prepare a proper 
verification request.'' \118\ Based upon this interpretation, duly 
authorized patients' agents (sellers) are able to obtain a duplicate 
copy of the patients' prescription upon request. In addition, patients, 
acting as their own agents, are able to obtain a duplicate copy of 
their prescription upon request.\119\
---------------------------------------------------------------------------

    \116\ 15 U.S.C. 7601(a)(2); 16 CFR 315.3(a)(2).
    \117\ See Staff Opinion Letter to the American Optometric 
Association Providing Guidance Regarding How Contact Lens 
Prescribers Should Respond to Requests for Patients' Contact Lens 
Prescriptions, Pursuant to the Fairness to Contact Lens Consumers 
Act and the Contact Lens Rule, Oct. 4, 2006 (stating that if the 
seller is an agent of the consumer, ``the prescriber has an 
obligation under the FCLCA and the Contact Lens Rule to provide the 
consumer's prescription'' to the seller) https://www.ftc.gov/public-statements/2006/10/requests-contact-lens-prescribers-provide-patients-contact-lens; 1-800 CONTACTS (Comment #568), Exhibit E 
(same).
    \118\ Id. The American Optometric Association takes exception to 
this interpretation, and argues that if Congress meant for retailers 
to be able to demand patients' prescription at any time, then ``the 
entire verification process would have been all but unnecessary.'' 
Comment #644. The Commission disagrees with this contention, 
however, because verification is simply an additional option for 
ensuring that patients have a valid prescription, one that is faster 
and less paper-intensive, for both the seller and prescriber, than 
requiring that the prescriber always provide the complete patient 
prescription. Moreover, the Act and the Rule state that the 
prescriber must provide or verify the contact lens prescription as 
directed by the patient's agent, thus leaving it up to the agent, if 
so authorized by the patient, to decide which method is preferable.
    \119\ 15 U.S.C. 7601(a)(2); 16 CFR 315.3(a)(2). In addition, the 
HIPAA Privacy Rule right of access requires a covered prescriber to 
provide a copy of a prescription to the patient upon request or to 
another person she designates. See 45 CFR 164.524(c)(3). See infra 
Section V.C.
---------------------------------------------------------------------------

    Furthermore, as discussed earlier, because the Commission believes 
that many prescribers are not providing patients with their 
prescriptions upon completion of their contact lens fitting,\120\ there 
is additional justification for ensuring that patients are able to 
obtain copies of their prescription when necessary. The Commission 
therefore believes that requiring prescribers to provide additional 
copies of contact lens prescriptions to patients upon request is 
consistent with the language and intent of the Act: Providing 
prescription portability while protecting consumer health. Consumers 
with ongoing access to their prescriptions will be able to obtain the 
correct contact lenses from the seller of their choosing.
---------------------------------------------------------------------------

    \120\ See supra Section III.A.1.
---------------------------------------------------------------------------

C. Section 315.3(a)(2)--Provide or Verify the Contact Lens Prescription

    Section 315.3(a)(2) of the Rule requires that prescribers shall, as 
directed by any person designated to act on behalf of the patient, 
provide or verify the contact lens prescription by electronic or other 
means.\121\
---------------------------------------------------------------------------

    \121\ 16 CFR 315.3(a)(2).
---------------------------------------------------------------------------

1. Sellers Designated To Act on Behalf of Patients
    In addition to the obligation to release the prescription to the 
patient at the completion of a contact lens fitting, the Rule also 
requires prescribers to provide the contact lens prescription to third 
parties acting on behalf of the patient.\122\ Accordingly, some 
sellers, at the direction of their customers, have requested copies of 
prescriptions from prescribers rather than just verifications of 
prescriptions.\123\
---------------------------------------------------------------------------

    \122\ Id.
    \123\ See, e.g., 1-800 CONTACTS (Comment #568).
---------------------------------------------------------------------------

    Because this practice historically has been a source of confusion 
for some eye care practitioners, the staff clarified, in a 2006 letter 
to the American Optometric Association, that the Rule obligates a 
prescriber to provide the consumer's complete prescription to a third-
party seller if the consumer has authorized that seller as an 
agent.\124\ In its letter, FTC staff also made clear that the Act and 
the Rule do not permit the prescriber to require that sellers provide 
written documentation of the patient's authorization before providing 
the seller with a copy of the patient's prescription.\125\ In response, 
the American Optometric Association has provided guidance to its 
members that they must comply with this provision of the Rule.\126\
---------------------------------------------------------------------------

    \124\ Staff Opinion Letter, supra note 116.
    \125\ The opinion letter also explains that neither the Health 
Insurance Portability and Accountability Act (``HIPAA'') of 1996 nor 
its implementing regulations require such written documentation of 
the authorization.
    \126\ American Optometric Association, Summary of Advisory from 
AOA General Counsel Regarding FCLCA Enforcement Update, Sept. 1, 
2015, http://www.aoa.org/Documents/advocacy/FTC_guidance_on_Rx_releases.pdf.
---------------------------------------------------------------------------

    This option may be gaining popularity with at least one seller. As 
explained by 1-800 CONTACTS, ``[d]ue in large part to poor prescriber 
compliance with prescription release requirements, many customers 
cannot provide a third-party seller with [a] copy of their contact lens 
prescription at the time they place their order.'' \127\ 1-800 CONTACTS 
also pointed out that this option benefits consumers because with a 
copy of the prescription on file, it can ship orders without any delay 
and without having to contact the prescriber each time the consumer 
wishes to purchase lenses.\128\
---------------------------------------------------------------------------

    \127\ Comment #568.
    \128\ Id.
---------------------------------------------------------------------------

    In its comment, however, the American Optometric Association argued 
that ``[r]equests by sellers directly to physicians for copies of 
patient prescriptions should be disfavored.'' \129\ The American 
Optometric Association asserted that sellers should use the 
verification system instead because verification requests consume less 
time than the retrieval, copying, and transmission of the actual 
prescription to sellers. The American Optometric Association 
acknowledged that it believes that the Rule's verification system needs 
improvement, but pointed out that it contains safeguards that requests 
for

[[Page 88537]]

copies of prescriptions do not.\130\ The American Optometric 
Association stated that sellers would only need to request a copy of a 
prescription directly from the prescriber when the patient does not 
submit the prescription and the patient is unable to provide any 
information about the prescription to the seller in order to permit use 
of the verification process.\131\
---------------------------------------------------------------------------

    \129\ Comment #644.
    \130\ Although the American Optometric Association comment did 
not specifically mention the safeguards, it is likely that the 
comment is referring to fact that if a prescription verification 
request lists a quantity of lenses that is excessive, the prescriber 
can deem such a request ``inaccurate.''
    \131\ Comment #644.
---------------------------------------------------------------------------

    Few other prescribers addressed this issue directly in their 
comments to this Rule review.\132\ However, the Commission also has 
received anecdotal reports that prescribers are still confused about 
this provision of the Rule, and some comments appear to conflate 
requests for a copy of a prescription with an incomplete verification 
request. For example, some prescribers complained that 1-800 CONTACTS 
was sending them incomplete verification requests, but instead it 
appears that 1-800 CONTACTS was sending the prescriber a request for 
the patient's prescription.
---------------------------------------------------------------------------

    \132\ Diener (Comment #6) (the ``rule should be restricted to 
use only upon recent patient request, not used in perpetuity to 
obtain records for marketing purposes''); Vidulich (Comment #612) 
(silent on the issue, but attaching request for a copy of the 
prescription).
---------------------------------------------------------------------------

    The Commission declines to adopt the American Optometric 
Association's suggestion that requests for copies of a prescription by 
a duly authorized seller be discouraged. The plain language of the Act 
and the Rule provide for this method of acquiring a prescription and 
the Association provided no evidence demonstrating that providing a 
copy of a prescription to a seller, rather than verifying a 
prescription, was significantly more burdensome to prescribers. As to 
the contention that the verification system contains safeguards that 
requests for prescriptions do not, the Commission points out that a 
prescription provided by a prescriber directly to the seller would 
necessarily include all relevant information and would avoid some of 
the issues raised by commenters about the flaws of the verification 
system. In addition, the copy of the prescription provided by the 
prescriber to the seller would contain an expiration date, which also 
serves as a safeguard against the improper dispensing of contact 
lenses.
    Despite clarifications that prescribers must provide copies of 
prescriptions to sellers when authorized by the patient, 1-800 CONTACTS 
complained in its comment that in its experience, about half of 
prescribers ``routinely ignore [their] requests'' for a copy of a 
patient's prescription.\133\ To address problems encountered by 
authorized agents in procuring copies of prescriptions, as well as 
ongoing prescriber confusion about this provision, two commenters 
proposed amending Section 315.3 ``to require that in response to an 
authorized request, the prescriber send the prescription to the agent 
(by mail, facsimile or a digital image of the prescription that is sent 
via electronic mail) within eight business hours as currently defined 
under the [Rule].'' \134\
---------------------------------------------------------------------------

    \133\ Comment #568.
    \134\ Id.; see also Warby Parker (Comment #593).
---------------------------------------------------------------------------

    In support of its proposal, 1-800 CONTACTS stated that, 
``[e]vidence shows that in about half the cases, prescribers ignore and 
never respond to 1-800's authorized requests for a copy of a customer's 
prescription.'' \135\ 1-800 CONTACTS does not specify this evidence in 
its comment. However, in a 2006 letter to the Commission, 1-800 
CONTACTS asserted that an audit of 264 requests for a copy of a 
customer's prescription shows that 46% of prescribers did not respond 
within five business days.\136\ The other commenter, Warby Parker, 
provided no evidence in support of its proposal.\137\
---------------------------------------------------------------------------

    \135\ Comment #568.
    \136\ See 1-800 CONTACTS (Comment #568), Exhibit E.
    \137\ Warby Parker (Comment #593). Warby Parker also proposed 
that the prescriber be required to maintain a log recording the date 
and time a patient's prescription was requested and released to the 
authorized agent.
---------------------------------------------------------------------------

    The Act and the Rule currently require the prescriber to provide a 
copy of a prescription to an authorized third party, but is silent on 
the timing of the response. The proposed modification would require 
prescribers to provide a prescription within eight business hours, the 
same amount of time that prescribers are afforded to respond to a 
verification request. The Commission notes, however, that there is a 
qualitative difference between responding to a verification request as 
opposed to providing a copy of a prescription. First, if the 
verification request is correct, the prescriber need take no 
action.\138\ Second, the proposed modification would require the 
prescriber to act within eight business hours, and if the prescriber 
did not act, or was unable to act, she would be in violation of the 
Rule. The eight-business-hour window for verification does not place 
the prescriber in such jeopardy. If the prescriber is unable to respond 
to a verification request in a timely fashion--for whatever reason--the 
request is verified, but the prescriber is not in violation of the 
Rule.
---------------------------------------------------------------------------

    \138\ Based on discussions with industry, it appears that the 
vast majority of verification requests are passively verified, with 
no prescriber action taken.
---------------------------------------------------------------------------

    At this time, the Commission has determined that the existing 
rulemaking record is not sufficient to support a Rule modification 
requiring a prescriber to respond to a request for a copy of a 
prescription within eight business hours. Accordingly, the Commission 
requests additional information from commenters on the costs and 
benefits of imposing a timeframe for prescribers to respond to requests 
from authorized third parties for a copy of a patient's prescription. 
The Commission also seeks comment on the appropriate amount of time for 
a prescriber to respond to prescription requests.\139\
---------------------------------------------------------------------------

    \139\ Another commenter, Opternative, a telehealth provider, 
proposed that the Commission ``consider expanding the verification 
requirements so that prescribers' obligations also apply to any 
other third party, including other prescribers, that is authorized 
by the patient.'' Comment #648. Section 315.3 explicitly states that 
the prescriber shall provide or verify the contact lens 
prescription, ``as directed by any person designated to act on 
behalf of the patient.'' Nothing in the Act or Rule precludes the 
construction of ``any person'' from including other prescribers. 
Furthermore, the HIPAA Privacy Rule permits a ``covered entity'' to 
use or disclose protected health information without patient 
authorization ``for treatment, payment, or health care operations.'' 
45 CFR 164.506. The Commission does not believe that the Rule needs 
any modification on this issue.
---------------------------------------------------------------------------

IV. Prescriber Verification

    Section 315.5 of the Rule provides the framework under which 
sellers may dispense contact lenses to consumers and requires sellers, 
before selling contact lenses, to either obtain a copy of the patient's 
prescription or verify the prescription. Section 315.5 also sets forth 
the procedures for obtaining such verification as well as seller 
recordkeeping obligations.

A. Section 315.5(a)--Prescription Requirement

    Section 315.5(a) of the Rule provides that a seller may sell 
contact lenses only in accordance with a contact lens prescription for 
the patient that is presented to the seller by the patient or 
prescriber directly or by facsimile; or verified by direct 
communication. This provision was taken verbatim from the Act.\140\
---------------------------------------------------------------------------

    \140\ 69 FR at 40495; see also 5 U.S.C. 7603(a).
---------------------------------------------------------------------------

1. Presentation of Prescriptions ``Directly or by Facsimile''
    In the initial rulemaking, the Commission determined that the 
``directly or by facsimile'' language of section 4(a)(1) of the Act 
allowed the

[[Page 88538]]

patient or prescriber to present a prescription by mail, by facsimile, 
or through a digital image of the prescription that is sent via 
electronic mail.\141\ The Commission also decided at that time not to 
include ``substantially equivalent future technologies'' within the 
scope of acceptable direct presentation mechanisms.\142\ In doing so, 
the Commission noted that section 4(a)(1) of the Act did not expressly 
reference or contemplate future technologies and the Commission was not 
aware of other technologies that met the statutory standard. The 
Commission declined at that time to include future technologies that 
``do not involve an exact copy of the prescription within the scope of 
acceptable direct presentation mechanisms.'' \143\
---------------------------------------------------------------------------

    \141\ 69 FR at 40495. The Commission also concluded that 
presentation of the prescription information from the consumer to 
the seller by telephone or by email (other than an email containing 
a digital image of the prescription) did not meet the ``directly or 
by facsimile'' standard imposed by the Act.
    \142\ Id.
    \143\ Id.
---------------------------------------------------------------------------

    Since implementation of the Rule in 2004, technological advances--
including many spurred by federal and state health information 
technology initiatives \144\--have fostered the proliferation of 
patient portals, through which health care providers can securely share 
medical information, such as prescription information, directly with 
patients and certain third parties. The use of patient portals for 
presentation of contact lens prescriptions to sellers may provide many 
benefits to consumers and competition. When using a portal, the patient 
or prescriber will have direct access to a current, exact copy of the 
contact lens prescription, reducing the chance that an inaccurate or 
expired prescription might be presented to the seller. The use of 
patient portals may also reduce costs for prescribers, patients, and 
sellers by making it easier and more efficient for patients to share 
and present contact lens prescriptions, and by reducing the number of 
verification requests placed on prescribers.
---------------------------------------------------------------------------

    \144\ Numerous federal and state programs have been designed to 
foster the development of health information technology and the 
electronic processing, storage, and transmission of patients' health 
information. For example, under the HITECH Act of 2009--Title XIII 
and Title IV of Division B of the American Recovery and Reinvestment 
Act of 2009--Congress directed the Medicare and Medicaid programs to 
make direct payments to eligible healthcare professionals, 
hospitals, and certain other healthcare providers specifically to 
incentivize the adoption and meaningful use of electronic health 
records systems (EHRs). American Recovery and Reinvestment Act of 
2009 (Recovery Act), Public Law 111-5, Sec.  4101(a), 4101(b), and 
4202 (2009) (Medicare incentives for eligible professionals, 
Medicare incentives for hospitals, and Medicaid provider payments, 
respectively). According to a recent report by the U.S. Department 
of Health & Human Services, more than $30 billion in such incentive 
payments were made between 2011 and 2015. U.S. Dep't Health & Human 
Servs., Office of the National Coordinator for Health Information 
Technology, Report to Congress, ``Update on the Adoption of Health 
Information Technology and Related Efforts to Facilitate the 
Electronic Use and Exchange of Health Information'' 18 (2016), 
https://www.healthit.gov/sites/default/files/Attachment_1_-_2-26-16_RTC_Health_IT_Progress.pdf. Regarding patient portals in 
particular, see, e.g., U.S. Dep't Health & Human Servs., Office of 
the National Coordinator for Health Information Technology, ``ONC 
Patient Engagement Playbook,'' https://www.healthit.gov/playbook/pe/introduction/.
---------------------------------------------------------------------------

    Because of these potential benefits, the Commission has made an 
initial determination that the provision ``directly or by facsimile'' 
includes the use of online patient portals by patients and prescribers 
to present contact lens prescriptions to sellers. In doing so, the 
Commission notes that the use of a patient portal necessarily involves 
``an exact copy of the prescription within the scope of acceptable 
direct presentation mechanisms.'' \145\ The Commission seeks comment on 
this clarification and requests that commenters provide information 
about whether the Commission should consider any other issues related 
to the presentation of prescriptions to sellers.
---------------------------------------------------------------------------

    \145\ 69 FR at 40495.
---------------------------------------------------------------------------

2. ``Verified by Direct Communication''
    Some individual commenters recommended that the Commission revise 
the Rule to remove verification by direct communication, and argued 
that the sale of contact lenses should be conditioned upon presentation 
of a written prescription by the consumer to the seller. These 
commenters noted that consumers are already being provided with a 
written prescription as required by the Rule, and that requiring 
prescribers to verify prescriptions with the seller as well was 
redundant, time-consuming and burdensome.\146\ Other commenters noted 
that with electronic means such as email and phone cameras readily 
available, the consumer should be responsible for presenting the 
prescription to the seller rather than having the prescriber verify the 
prescription.\147\ Other commenters argued that contact lens 
prescriptions should be treated the same way as prescriptions for 
medications, and that consumers should only be able to obtain contact 
lenses by presenting a written prescription.\148\ Some commenters also 
stated that relying on a written prescription to dispense lenses, 
rather than prescriber verification, would close loopholes in the 
verification framework that may allow consumers to obtain lenses 
without a valid, unexpired prescription.\149\
---------------------------------------------------------------------------

    \146\ Carroll (Comment #5), Driscoll (Comment #67); Kirk 
(Comment #131); Kalman (Comment #150); Baur (Comment #170); Bricker 
(Comment #195); Ahn (Comment #215); Comer (Comment #221); Kubo 
(Comment #234); Sanders (Comment #235); Williston (Comment #252); 
Campbell (Comment #348); Falcon (Comment #505); Walton (Comment 
#543).
    \147\ Kiener (Comment #74); Kubo (Comment #234); McWilliams 
(Comment #362); Falcon (Comment #505); Pham (Comment #641).
    \148\ Driscoll (Comment #67); Moody (Comment #92); Filandro 
(Comment #129); Kirk (Comment #131); Kalman (Comment #150); Boyer 
(Comment #246); Bolenbaker (Comment #357).
    \149\ Driscoll (Comment #67); Dieckow (Comment #151); Ahn 
(Comment #215); Sanders (Comment #235); Smith (Comment #319).
---------------------------------------------------------------------------

    The language of Section 315.5(a)(2) was taken verbatim from the 
Act.\150\ Because Congress decided to structure the prescription 
verification framework to allow for either the direct presentation of a 
prescription to a seller or, alternatively, the verification of a 
prescription by direct communication, elimination of verification by 
direct communication is beyond the scope of this rule review.
---------------------------------------------------------------------------

    \150\ 69 FR at 40495; see also 5 U.S.C. 7603(a).
---------------------------------------------------------------------------

3. Automated Telephone Calls as a Method of Direct Communication
    The Commission received numerous comments objecting to contact lens 
sellers' use of automated telephone calls as a method to communicate 
verification requests.\151\ These commenters, who often refer to these 
automated telephone calls as robocalls, are largely prescribers, 
students of optometry, and associations whose members are prescribers.
---------------------------------------------------------------------------

    \151\ The American Optometric Association pointed to the 
public's general disfavor of robocalls, noting that they are 
commonly understood to be an abuse of telephone communication, one 
for which companies have been fined millions of dollars. Comment 
#644. The FTC disagrees with this characterization of automated 
seller verification calls. Contact lens seller verification calls 
are not sales calls covered by the Telemarketing Sales Rule 
(``TSR''), 16 CFR 310, which prohibits certain robocalls. In 
addition, the TSR does not apply to most business-to-business 
communications. 16 CFR 310.6(b)(7).
---------------------------------------------------------------------------

    Commenters described problems arising from the use of automated 
telephone calls,\152\ and some

[[Page 88539]]

commenters called for an outright ban of the use of such calls.\153\ A 
number of commenters indicate that the automated verification calls are 
difficult to understand or confusing \154\ or do not provide all of the 
information required to be a valid request.\155\ Some optometrists or 
state optometric associations, many of which consist of or represent 
small businesses,\156\ complain that these calls are too long and time 
consuming,\157\ disturb their practices, take time away from providing 
care and attention to their patients, and make the phone lines 
unavailable for their patients.\158\ Commenters explained that part of 
the reason the automated calls are so disruptive is that the caller 
continuously redials until a message is fully communicated.\159\ In 
response to the recurring disruption, one prescriber stated that his 
office simply ignores the robocalls.\160\
---------------------------------------------------------------------------

    \152\ E.g., Stahl (Comment #19); Lum (Comment #21); Peterson 
(Comment #22); Borsky (Comment #26); Matthews (Comment #25); Maanum 
(Comment #23); Chriqui (Comment #31); Hodes (Comment #42); Dodge 
(Comment #44); Virginia Optometric Association (Comment #46); 
Alabama Optometric Association (Comment #48); Howe (Comment #53); 
Iowa Optometric Association (Comment #79); Michigan Optometric 
Association (Comment #86); Mirkin (Comment #111); California 
Optometric Association (Comment #119); Hicks (Comment #256); Leach 
(Comment #257); Chang (Comment # 258); Pentacost (Comment #268); 
Easton (Comment #432); Koch (Comment #539); Connecticut Association 
of Optometrists (Comment #560); Lueng (Comment #607); Wu (Comment 
#608); Vidulich (Comment #612); Lai (Comment #620); Coalition for 
Patient Vision Care Safety (Comment #621); Pechko (Comment #628); 
American Optometric Association (Comment #644); Rubow (Comment 
#649); Liu (Comment #656); Louie (Comment #657); Fong (Comment 
#669); Vo (Comment #673).
    \153\ E.g., Virginia Optometric Association (Comment #16); Stahl 
(Comment #19); Lum (Comment #21); Peterson (Comment #22); Maanum 
(Comment #23); Matthews (Comment #25); Borsky (Comment #26); Chriqui 
(Comment #31); Hodes (Comment #42); Dodge (Comment #44); Alabama 
Optometric Association (Comment #48); Iowa Optometric Association 
(Comment #79); Michigan Optometric Association (Comment #86); 
California Optometric Association (Comment #119); Hicks (Comment 
#256); Leach (Comment #257); Chang (Comment # 258); Easton (Comment 
#432); New Mexico Optometric Association (Comment #211); Koch 
(Comment #539); Connecticut Association of Optometrists (Comment 
#560); Tennessee Association of Optometric Physicians (#575); 
Colorado Association of Optometrists (Comment #584); Lueng (Comment 
#607); Wu (Comment #608); Vidulich (Comment #612); Lai (Comment 
#620); Coalition for Patient Vision Care Safety (Comment #621); 
Pechko (Comment #628); American Optometric Association (Comment 
#644); Liu (Comment #656); Louie (Comment #657); Fong (Comment 
#669); Vo (Comment #673).
    \154\ E.g., Stahl (Comment #19); Lum (Comment #21); Peterson 
(Comment #22); Borsky (Comment #26); Matthews (Comment #25); Maanum 
(Comment #23); Chriqui (Comment #31); Hodes (Comment #42); Dodge 
(Comment #44); Virginia Optometric Association (Comment #46); 
Alabama Optometric Association (Comment #48); Howe (Comment #53); 
Iowa Optometric Association (Comment #79); Michigan Optometric 
Association (Comment #86); Mirkin (Comment #111); California 
Optometric Association (Comment #119); Hicks (Comment #256); Leach 
(Comment #257); Chang (Comment # 258); Easton (Comment #432); Koch 
(Comment #539); Connecticut Association of Optometrists (Comment 
#560); Lueng (Comment #607); Wu (Comment #608); Vidulich (Comment 
#612); Lai (Comment #620); Coalition for Patient Vision Care Safety 
(Comment #621); Pechko (Comment #628); American Optometric 
Association (Comment #644) (stating they have often received 
complaints over the last ten years from optometrists that robocalls 
from 1-800 CONTACTS were difficult to understand); Rubow (Comment 
#649) (stating that if the entire recorded message is not completed 
within the allotted time on the answering machine, they then receive 
a message from an actual live person where the person speaks so fast 
that it requires playing back the message four or five times in 
order to get all the information); Liu (Comment #656); Louie 
(Comment #657); Fong (Comment #669);Vo (Comment #673).
    \155\ Virginia Optometric Association (#46); Iowa Optometric 
Association (Comment #79) (stating robocalls too often provide 
incomplete information); Hicks (Comment #256); Pentacost (Comment 
#268) (stating automated messages start playing well before the 
voicemail begins recording so that the office does not catch the 
name of the patient or which company left the message); Connecticut 
Association of Optometrists (Comment #560) (stating robocalls too 
often provide incomplete information); Coalition for Patient Vision 
Care Safety (Comment #621) (stating robocallers leave voice messages 
without contact information and may be cut off before conveying in 
entirety the patient's information); American Optometric Association 
(Comment #644) (stating they have often received complaints over the 
last ten years from optometrists that robocalls from 1-800 CONTACTS 
did not include all of the necessary information to confirm a 
prescription).
    \156\ E.g., Pennsylvania Optometric Association (Comment #46); 
Iowa Optometric Association (Comment #79); Connecticut Association 
of Optometrists (Comment #560); Tennessee Association of Optometric 
Physicians (Comment #575); Rubow (Comment #649).
    \157\ E.g., Stahl (Comment #19); Lum (Comment #21); Peterson 
(Comment #22); Maanum (Comment #23); Matthews (Comment #25); Borsky 
(Comment #26); Iowa Optometric Association (Comment #79); Lai 
(Comment #620); Chriqui (Comment #31); Hodes (Comment #42); Dodge 
(Comment #44); Plumb (Comment #219); Hicks (Comment #256); Leach 
(Comment #257); Chang (Comment # 258); Easton (Comment #432); Koch 
(Comment #539); Tennessee Association of Optometric Physicians 
(#575); Lueng (Comment #607); Wu (Comment #608); Vidulich (Comment 
#612); Coalition for Patient Vision Care Safety (Comment #621); 
Pechko (Comment #628); Liu (Comment #656); Louie (Comment #657); 
Fong (Comment #669); American Optometric Association (Comment #644); 
Vo (Comment #673).
    \158\ Easton (Comment #432); Louie (Comment #657). See also Iowa 
Optometric Association (Comment #79) (explaining the need to protect 
small businesses from disruptive calls that interfere with treating 
patients and tie up phones); Pham (Comment #232); Tennessee 
Association of Optometric Physicians (Comment #575); Michigan 
Optometric Association (Comment #86).
    \159\ See, e.g., Wisconsin Optometric Association (Comment #30); 
Pennsylvania Optometric Association (Comment #46); New Mexico 
Optometric Association (Comment #211); Tennessee Association of 
Optometric Physicians (Comment #575).
    \160\ Scolin (Comment #369).
---------------------------------------------------------------------------

    Other commenters mentioned that sellers provide the patient name 
several sentences into, or at the very end of, the verification 
request, making it difficult for prescribers' offices to respond 
efficiently and to verify the prescription in real time.\161\ Some 
commenters also complained that the automated calls come during 
business hours when they are busy with patients.\162\ Meanwhile, other 
commenters complain that the calls come in during non-business hours, 
and express concern that as a result, sellers may release the contact 
lenses to patients without the prescriber having time to confirm the 
prescription.\163\
---------------------------------------------------------------------------

    \161\ Brauer (Comment #68); Kalman (Comment #150); Egger 
(Comment #163); Plumb (Comment #219); Rosemore (Comment #468).
    \162\ See, e.g., Chang (Comment #126); Scolin (Comment #369); 
Tennessee Association of Optometric Physicians (#575).
    \163\ Connecticut Association of Optometrists (Comment #560); 
Colorado Optometric Association (Comment #584).
---------------------------------------------------------------------------

    Due to the aforementioned problems with automated telephonic 
verification requests, the Coalition for Patient Vision Care Safety 
asserted that prescribers are often unable to provide the proper 
verification of the patient's prescription information within eight 
business hours, triggering the passive verification. As a result, 
patients may receive contact lenses based on outdated or incorrect 
prescription information.\164\ The Coalition stated that ``the fact 
that patients are receiving contact lenses based on incorrect, 
outdated, or unverified prescription information runs counter to the 
FDA's medical device safety standards, and can also lead to serious 
vision issues.'' \165\
---------------------------------------------------------------------------

    \164\ Comment #621. See also Iowa Optometric Association 
(Comment #79); Chakuroff (Comment #189); Bricker (Comment #195); 
Spaeth (Comment #486).
    \165\ Comment #621.
---------------------------------------------------------------------------

    On the other hand, 1-800 CONTACTS requested the Commission retain 
the use of automated phone systems as an acceptable form of direct 
communication for verification purposes. It argued that changing the 
status quo would be ``unjustified, contrary to congressional intent and 
not in the interest of consumers.'' \166\ According to 1-800 CONTACTS, 
it has experimented with other forms of direct communication and 
concluded that ``a well-functioning automated system that incorporates 
the latest technology is the most efficient means of handling the large 
volume of verification requests that are required today.'' \167\ 1-800 
CONTACTS indicated it has invested significant resources into the 
development of a system that is less subject to human error, allows 
accurate information to be given consistently to every prescriber, and 
provides assurance that it is compliant with the Rule. The company 
claimed that its system has an automated voice that is clear and easy 
to understand, and contains user-friendly options, such as the 
opportunity to pause the verification script or to request the system 
call back at a later time. 1-800 CONTACTS'

[[Page 88540]]

comment also noted that, while its messages are automated, calls are 
initiated by live agents to guarantee that all calls are placed to the 
intended prescribers.\168\ 1-800 CONTACTS also asserted that when a 
message is left on an answering machine, the live agent remains on the 
line during the entire automated message to ensure that the complete 
message is conveyed to the prescriber.\169\
---------------------------------------------------------------------------

    \166\ Comment #568.
    \167\ Id.
    \168\ Id.
    \169\ Id.
---------------------------------------------------------------------------

    According to 1-800 CONTACTS, each week it places approximately 
100,000 calls to prescribers to verify prescriptions. The complete 
phone script for an automated verification call from 1-800 CONTACTS is 
2 minutes, 29 seconds (149 seconds) in length, and prescribers familiar 
with the system have the option to skip the first 48 seconds of the 
message to reduce the total time of the message to 1 minute, 41 seconds 
(101 seconds). 1-800 CONTACTS indicated that the average prescriber 
receives only one verification request per week from the company,\170\ 
and the highest volume office in its records received, on average, six 
verification requests per week in 2014.\171\ The company explained that 
it places verification calls as it receives orders, and that it 
receives orders 24 hours a day, seven days a week, with many orders 
coming in on weekends or during evening hours. The company further 
explained that it leaves verification messages shortly after its 
receipt of orders because a continuous call process is ``logistically 
efficient and prevents a shipping bottleneck at a single hour each 
day.'' \172\
---------------------------------------------------------------------------

    \170\ However, if the call is not completed, 1-800 CONTACTS will 
call the prescriber again. Therefore, one verification request may 
result in more than one call.
    \171\ Id.
    \172\ Id.
---------------------------------------------------------------------------

    Regardless of when it places the verification call to the 
prescriber, however, 1-800-CONTACTS stated that it never ships an order 
under the passive verification system before passage of eight business 
hours. The company added that in almost 30% of verification requests, 
prescribers hang up on verification calls.\173\
---------------------------------------------------------------------------

    \173\ Comment #187. See also Consumers Union (Comment #677) 
(calling prescriber hang-ups a reported problem).
---------------------------------------------------------------------------

    The Commission did not receive other comments from contact lens 
sellers about their use of automated verification systems to verify 
prescriptions.\174\ Consumers Union, the policy and advocacy division 
of Consumer Reports, also commented in support of automated calling 
systems, stating that such systems, of which eye doctors should now be 
aware, are a reasonable means for a retailer to efficiently handle a 
large volume of prescription requests. Consumers Union also stated that 
most eye doctors' offices have automated answering systems and it 
believed they could set up an efficient means for recording the 
verification request information without significant burden.\175\
---------------------------------------------------------------------------

    \174\ Warby Parker, an online seller of eyeglasses, commented on 
its support of the use of automated phone systems as a form of 
direct communication for verification purposes. Comment #593.
    \175\ Comment #677.
---------------------------------------------------------------------------

    The Act expressly authorizes sellers to send prescription 
verification requests by direct communication \176\ and defines 
``direct communication'' to include communication by telephone, 
facsimile, or electronic mail.\177\ In previously considering this 
issue, the Commission noted that telephone is commonly understood to 
include automated telephone systems. The Commission therefore concluded 
in the initial rulemaking that ``it would thus seem to be contrary to 
Congressional intent to prohibit the use of this technology.'' \178\ 
Nevertheless, then and now, the Commission emphasizes that automated 
telephone systems must fully comply with all applicable Rule 
requirements in order to transmit valid verification requests.
---------------------------------------------------------------------------

    \176\ 15 U.S.C. 7603(a)(2).
    \177\ 15 U.S.C. 7603(g).
    \178\ 69 FR at 40489.
---------------------------------------------------------------------------

    For example, any automated verification request must provide 
complete verification request information as required under section 
315.5(b),\179\ and this information must be either received by a person 
on the telephone or otherwise received in full (e.g., all of the 
requisite information is left on a telephone answering machine). 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, or if it contains incomplete 
verification information. The seller must also allow eight business 
hours for the prescriber to respond. During the initial rulemaking in 
2004, the Commission indicated that it would ``continue to monitor 
whether full, valid requests for verification of a prescription are 
being made through the use of automated telephone systems'' and may 
revisit the issue ``[i]f evidence demonstrates that sellers are not 
making valid verification requests but are providing consumers with 
contact lenses despite deficient requests.'' \180\
---------------------------------------------------------------------------

    \179\ When seeking verification of a prescription, the seller 
must provide the prescriber with: The patient's full name and 
address; the contact lens power, manufacturer, base curve or 
appropriate designation, and diameter when appropriate; the quantity 
of lenses ordered; the date of patient request; the date and time of 
verification request; the name of a contact person at the seller's 
company, including facsimile and telephone numbers; and, if the 
seller is counting the prescriber's regular Saturday hours as 
``business hours,'' a clear statement of the prescriber's regular 
Saturday business hours. 16 CFR 315.5(b).
    \180\ 69 FR at 40489.
---------------------------------------------------------------------------

    The comments submitted in this Rule review by optometrists, 
students of optometry, and their trade associations provide the 
Commission with some evidence that some prescribers are receiving 
incomplete or otherwise inadequate verification requests. In addition, 
the Coalition for Patient Vision Care Safety asserted there is 
substantial evidence that verification requests are deficient and the 
American Optometric Association claimed that problems with 1-800 
CONTACTS' automated verification systems are often reported by its 
members.\181\ However, commenters did not provide any empirical data 
regarding the frequency of these various practices, average or 
aggregate costs associated with automated calls in particular, or the 
number of illegal or otherwise deficient contact lens sales that result 
from such calls. Furthermore, the Commission lacks evidence indicating 
whether these problems occur with automated calls generally or are 
chiefly associated with only one or a small group of sellers. If the 
reported problems chiefly are associated with the practices or systems 
of a limited number of sellers, the Commission would consider education 
of, or enforcement against, such sellers, rather than an amendment to 
the Rule at this time.\182\
---------------------------------------------------------------------------

    \181\ Coalition for Patient Vision Care Safety (Comment #621); 
American Optometric Association (Comment #644).
    \182\ In fact, a number of state optometric associations note 
that the costs prescribers' offices expend related to the Rule are 
most often due to incomplete or otherwise inadequate verification 
requests. Michigan Optometric Association (Comment #86); Wisconsin 
Optometric Association (Comment #30); Pennsylvania Optometric 
Association (Comment #46); Iowa Optometric Association (Comment 
#79); New Mexico Optometric Association (Comment #211). Thus, 
education and enforcement efforts to improve sellers' compliance 
with the verification aspects of the Rule may have a large benefit 
for prescribers, without the need to prohibit automated verification 
calls.
---------------------------------------------------------------------------

    Incomplete or incoherent verification requests are not valid 
verification requests.\183\ However, a seller may not always realize 
that it has made an invalid request and, hence, might dispense lenses 
under an assumption of

[[Page 88541]]

passive verification if the prescriber does not contact the seller 
within eight business hours of the invalid request. Accordingly, to 
prevent the improper dispensing of lenses, the Commission encourages 
prescribers to contact the seller in these circumstances to inform them 
that the request is invalid and state the basis for the invalidity. 
Once the prescriber communicates that the request is invalid and states 
the basis for the invalidity, the seller shall not fill the order. 
Alternatively, for incomplete requests, the Commission encourages 
prescribers, to the extent they are able, to complete the missing 
information in order to facilitate the dispensing of the contact 
lenses.
---------------------------------------------------------------------------

    \183\ 69 FR at 40496 (``The Commission emphasizes that the sale 
of contact lenses based on a verification request which does not 
contain all of the required information constitutes a Rule 
violation.'').
---------------------------------------------------------------------------

    The Commission is sensitive to the business concerns of the 
prescribers who complain about the burden and inconvenience they 
experience from the sellers' use of automated telephone systems. 
However, the Commission has not seen convincing evidence that the 
volume of automated verification calls they receive each day presents a 
burden that is not outweighed by the competitive benefits of the Rule, 
or that these practices frequently result in illegal sales of contact 
lenses. If the Commission receives evidence of a compelling widespread 
problem, it may revisit its position on the use of automated 
verification requests.\184\ At this point, however, the Commission 
declines to prohibit the use of automated verification calls.
---------------------------------------------------------------------------

    \184\ The Commission notes that since Congress expressly 
permitted telephone as a form of direct communication for 
verification, if the Commission were to prohibit automated telephone 
calls, more live communications might result. Such communications 
would not necessarily alleviate all of the concerns expressed by 
commenters and might cause more problems for sellers with a large 
volume of orders and/or a small amount of staff.
---------------------------------------------------------------------------

    Nevertheless, the Commission encourages sellers, to the extent 
possible, to consider whether they could alleviate some of the 
commenters' concerns by modifying their automated telephonic 
verification procedures or, alternatively, by increasing the use of 
other permissible communication methods. The Commission also seeks 
additional information on possible modifications to the Rule that, 
short of prohibiting automated verifications calls, could address the 
issues raised by commenters relating to these calls.
    The Commission declines to restrict when sellers may place 
automated phone verification calls. As long as sellers are placing 
valid and complete verification requests, and are not shipping orders 
prior to active verification, or the passage of eight business hours, 
automated telephone verification requests placed outside of a 
prescriber's business hours comply with the Rule. Moreover, a review of 
the comments reveals that some prescribers object to calls during 
office hours, while others object to calls during evening and weekend 
hours. The Commission therefore does not propose, at this time, to 
limit the time period when sellers may place automated calls.

B. Section 315.5(b)--Information for Verification

    Section 315.5(b) delineates the information required for a 
prescription verification request: (1) Patient's full name and address; 
(2) the contact lens power, manufacturer, base curve or appropriate 
designation, and diameter when appropriate; (3) the quantity of lenses 
ordered; (4) the date of patient request; (5) the date and time of 
verification request; (6) the name of a contact person at the seller's 
company, including facsimile and telephone numbers; and (7) if the 
seller opts to include the prescriber's regular business hours on 
Saturday as ``business hours'' for purposes of computing the eight 
business hour calculation, a clear statement of the prescriber's 
regular Saturday business hours.
1. Vendor Contact Information
    A few individual prescribers stated that they were unable to 
contact vendors in order to get additional information when the 
verification request was incomplete.\185\ The American Optometric 
Association also voiced concerns about the difficulty that prescribers 
have in reaching an individual at 1-800 CONTACTS to discuss 
prescription concerns.\186\ Several state optometric associations 
asserted that physician small businesses may spend significant time on 
hold or attempting to use various phone numbers or automated prompts to 
reach a live person. These commenters recommended that the Commission 
require larger contact lens retailers to make available more than one 
individual at a company to act as the contact person for physician 
questions and concerns.\187\ Commenters did not explain the nature of 
the incomplete verification requests such that a live person was 
necessary to address the inadequacy of the request, nor did they 
elaborate upon the reasons why prescribers need to reach live persons 
at contact lens retailers to answer ``questions and concerns.''
---------------------------------------------------------------------------

    \185\ Truong (Comment #55); Cervantes (Comment #479).
    \186\ Comment #644.
    \187\ Virginia Optometric Association (Comment #16); Wisconsin 
Optometric Association (Comment #30); Utah Optometric Association 
(Comment #39); Pennsylvania Optometric Association (Comment #46); 
Alabama Optometric Association (Comment #48); Iowa Optometric 
Association (Comment #79); Michigan Optometric Association (Comment 
#86); California Optometric Association (Comment #119); New Mexico 
Optometric Association (Comment #211); Mississippi Optometric 
Association (Comment #548); Ohio Optometric Association (Comment 
#556); Connecticut Association of Optometrists (Comment #560); North 
Carolina State Optometric Society (Comment #567); Tennessee 
Association of Optometric Physicians (Comment #575); Colorado 
Optometric Association (Comment #584); New Jersey Society of 
Optometric Physicians (Comment #595).
---------------------------------------------------------------------------

    The Commission declines to propose this Rule modification. The Rule 
requires that the seller provide the name of a contact person at the 
seller's company, including facsimile and telephone numbers.\188\ In 
requiring a facsimile number as well as a telephone number, it is clear 
that the Act and the Rule intended to provide for direct communication, 
but not necessarily contemporaneous, live communication. The language 
of the Act and the Rule anticipates that some sellers will communicate 
with prescribers via live agents, but does not require it. Instead, the 
Act and the Rule allow sellers also to communicate with prescribers 
about verification requests via facsimile as well as voicemail.
---------------------------------------------------------------------------

    \188\ 16 CFR 315.5(b)(6).
---------------------------------------------------------------------------

    Furthermore, the Commission does not believe it is necessary to 
require large contact lens retailers to have more than one individual 
available for prescriber questions and concerns, as long as a contact 
person is ``reasonably accessible to the prescriber.'' \189\ As 
discussed in the initial rulemaking, the vendor contact provision is 
intended to ensure that the prescriber is able to reach a responsible 
person at the seller's company.\190\ No evidence was presented showing 
how often prescribers experience difficulty in obtaining reasonable 
access to a contact person at the seller's company.\191\ Without such

[[Page 88542]]

evidence, the Commission cannot determine whether a modification of the 
Rule is necessary.
---------------------------------------------------------------------------

    \189\ 69 FR at 40497.
    \190\ Id. The Rule also requires that during the eight-business-
hour window, ``the seller shall provide a reasonable opportunity for 
the prescriber to communicate with the seller concerning the 
verification request.'' 16 CFR 315.5(c)(3). In the initial 
rulemaking, the Commission declined to articulate with specificity 
the equipment or personnel that sellers must have to handle 
verification requests, in order to give sellers the flexibility to 
determine the most effective and efficient means of providing the 
opportunity to communicate. Rather, the Commission promulgated the 
final Rule to require that sellers provide prescribers a 
``reasonable opportunity'' for the prescriber to communicate with 
the seller. 69 FR 40499.
    \191\ Likewise, the Commission did not receive evidence 
sufficient to show that the methods for communication offered by 
sellers do not provide prescribers with a reasonable opportunity to 
communicate with the seller about the verification request.
---------------------------------------------------------------------------

    Moreover, as discussed earlier,\192\ if a verification request is 
incomplete, the request is invalid. If the prescriber communicates to 
the seller within the Rule-specified deadline that the verification 
request or the prescription is invalid,\193\ the seller may not fill 
the prescription.\194\ It is not necessary to reach a live person to 
perform this function. Once alerted that a verification request is 
invalid and the reason for the invalidity, the burden falls on the 
seller to resolve the invalidity, if possible. In addition, in routine 
cases it would not be necessary to reach a live person in order to 
correct a prescription. Accordingly, the rulemaking record contains 
insufficient evidence to show that mandating a mechanism for 
contemporaneous live communications is necessary to carry out the Act.
---------------------------------------------------------------------------

    \192\ See supra Section IV.A.3.
    \193\ If a prescriber deems a prescription invalid, the Rule 
requires that the prescriber specify the basis for the invalidity. 
16 CFR 315.5(d).
    \194\ In addition, Warby Parker proposed that the Commission 
include stronger language in the Rule to make clear that it is a 
violation for prescribers to respond to a verification request by 
stating that prescription information is incorrect when, in fact, it 
is not; or to respond to a verification request by stating that 
prescription information is inaccurate or invalid without providing 
the basis for the inaccuracy or invalidity of the prescription. 
Comment #593. The Rule already provides that if a prescriber 
indicates that a prescription is inaccurate or invalid, the 
prescriber shall specify the basis for doing so. A failure to do so 
violates the Rule. See 16 CFR 315.5(d). Further, falsely indicating 
that a prescription was inaccurate would essentially equal a failure 
to ``correct'' a prescription, as mandated by the Rule and 
therefore, also would be a violation. See id. The Commission does 
not believe it needs to clarify these prescriber obligations 
further. Warby Parker also proposed that the Commission clarify that 
it is a violation of the Rule for a prescriber to interfere, in any 
way, with a seller's effort to verify a prescription. This proposal 
is not described in detail nor is the frequency of this problem 
supported with empirical evidence. The Commission therefore declines 
to propose this Rule modification.
---------------------------------------------------------------------------

    The American Optometric Association also urged the Commission to 
amend the Rule to require sellers to respond to prescriber questions 
within an eight-business-hour window, or cancel the sale without 
verification. The Association's comment did not explain the types of 
concerns that prescribers need to discuss with live agents at contact 
lens retailers. This proposal would require that once a prescriber 
contacted a seller with concerns, the seller could not assume the 
prescription was verified. Instead, the seller would be required to 
personally contact the prescriber and discuss the concerns within eight 
business hours, or cancel the sale.\195\
---------------------------------------------------------------------------

    \195\ Comment #644.
---------------------------------------------------------------------------

    The Commission declines to propose this modification as well. As 
discussed above, neither the Act nor the Rule requires contemporaneous, 
live communication between prescribers and sellers. Furthermore, the 
Commission believes that such a requirement would undercut the Act's 
passive verification framework. Such a mechanism could conceivably 
allow any prescriber to lodge a concern or question and thereby halt 
the passive verification mechanism. As discussed above, if the 
prescription verification request is incomplete or inaccurate, or if 
the prescription is expired or otherwise invalid, the prescriber may 
alert the seller. The seller cannot fill a prescription if the 
prescriber has indicated that the prescription is expired or otherwise 
invalid.
2. Prescribers' Selection of Communication Mechanism
    A few commenters suggested that the prescriber should have the 
ability to choose the method of communication sellers use to 
communicate verification requests with their offices.\196\ One 
commenter stated that she requested a seller make all future 
verification requests through facsimile, but the seller, who sometimes 
made requests via facsimile, refused her request.\197\ A number of 
prescribers expressed a preference for sellers to use another type of 
communication to verify contact lens prescriptions, including facsimile 
or email.\198\ A few prescribers requested that sellers use live 
telephone calls to communicate with their offices.\199\ The concept of 
having prescribers select the communication method that the seller 
would use to verify a prescription (i.e. by telephone, fax, or online) 
was previously raised with the Commission during the initial 
rulemaking.\200\ As the Commission then determined, 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 use to submit verification 
requests.\201\ Nevertheless, nothing prevents a seller from honoring a 
prescriber's request for a certain type of communication and the 
Commission suggests that sellers evaluate whether honoring such 
requests would increase the speed and efficiency of the verification 
process.
---------------------------------------------------------------------------

    \196\ Filandro (Comment #129); Chakuroff (Comment #189); Stuart 
(Comment #635).
    \197\ Chakuroff (Comment #189).
    \198\ Mirkin (Comment #111) (stating that fax or email 
verifications are quick and easy to answer); Chang (Comment # 126) 
(requesting fax or email verification system); Filandro (Comment 
#129) (requesting sellers offer all offices fax option for 
verification requests); Koch (requesting use of fax); Rubow (Comment 
#649) (seeking a requirement that online retailers verify through a 
route that is intelligible, including fax or a live person). But see 
Hicks (Comment #256) (stating automated fax systems are difficult 
for their offices as the fax machine is in an area of the business 
that is not frequently used); Ambler (Comment #524) (complaining of 
receipt of poor quality faxes when the office is closed).
    \199\ Mirkin (Comment #111); Hicks (Comment #256) (stating a 
simple, quick phone call is much easier and would result in faster 
turnaround times for the patients); Rubow (Comment #649).
    \200\ 69 FR at 40497.
    \201\ See 15 U.S.C. 7603(g).
---------------------------------------------------------------------------

C. Section 315.5(c)--Verification Events

    Section 315.5(c) sets forth the three circumstances under which a 
seller can consider a prescription ``verified by direct communication'' 
and proceed to sell contact lenses to its customer: (1) The prescriber 
confirms the prescription is accurate by direct communication with the 
seller; (2) the prescriber informs the seller through direct 
communication that the prescription is inaccurate and provides the 
accurate prescription; and (3) the prescriber fails to communicate with 
the seller within eight business hours after receiving a proper 
verification request from the seller.\202\
---------------------------------------------------------------------------

    \202\ 16 CFR 315.5(c).
---------------------------------------------------------------------------

1. Passive Verification
    A number of commenters expressed the view that because contact 
lenses are restricted medical devices, they should not be dispensed 
unless the prescriber actively verifies the prescription.\203\ The 
Contact Lens Association of Ophthalmologists, for example, in arguing 
for the elimination of passive verification, stated that it ``puts the 
health of consumers at risk and is inconsistent with regulatory 
practices for confirmation of the validity and accuracy of 
prescriptions for drugs and for other Class II and Class Ill medical 
devices.'' \204\
---------------------------------------------------------------------------

    \203\ California Optometric Association (Comment #119) 
(``Contact lenses are medical devices. Therefore, it is reasonable 
to replace passive verification with active verification for contact 
lenses.''); Weissman (Comment #50) (same); Bainbridge (Comment #152) 
(``Start treating contact lenses like the medical devices they are 
and start respecting the clinical judgment of doctors.'').
    \204\ Comment #572.
---------------------------------------------------------------------------

    Other commenters expressed the concern that the passive 
verification framework can be manipulated and, therefore, does not 
adequately ensure that patients receive contact lenses in accordance 
with proper medical

[[Page 88543]]

oversight. For example, some commenters asserted that passive 
verification is problematic because patients, in some circumstances, 
may be able to obtain lenses by providing fictional or incorrect 
information to sellers.\205\ A common scenario relayed by commenters is 
that if the patient provides the seller with the name of a fictional 
prescriber and a fictional fax number, the prescription will be 
passively verified when there is no response within eight hours.\206\
---------------------------------------------------------------------------

    \205\ Wang (Comment #94) (discussing ``deliberate attempts to 
evade verification with the knowledge that a lack of verification is 
equivalent to a prescription being verified''); Anklin (Comment 
#107) (describing the use of incorrect or even falsified 
information); Filandro (Comment #129) (noting that patients can fax 
the request to their own home or email); Stewart (Comment #136) 
(patients are able to use any fax number); McCutchan (Comment #624) 
(describing use of fax numbers for practices that are no longer 
active).
    \206\ Caughell (Comment #7); Truong (Comment #55); Navarro 
(Comment #117); Zierlein (Comment #123); Ammon (Comment #128); 
Ciszek (Comment #134); Lee (Comment #158); Ambrose (Comment #196); 
Ahmed (Comment #209); Dell (Comment #227); Williston (Comment #252); 
Pentecost (Comment #268); Smith (Comment #319); Makler (Comment 
#356); Bolenbaker (Comment #357); McWilliams (Comment #362); Diaz 
(Comment #380); Liebig (Comment #478); Balitski (Comment #485); 
Garcia (Comment #511); Loerzel (Comment #550); Pham (Comment #641); 
Lisenby (Comment #662).
---------------------------------------------------------------------------

    Some prescribers reported instances where some patients were never 
seen by a prescriber, and apparently the consumer just pulled the 
prescriber information from a Web site in an attempt to get a 
prescription verified via passive verification.\207\ A few commenters 
reported that patients said they were instructed--by sellers--to use 
any optometrist name, or any facsimile number, in order to facilitate 
the order.\208\ A few commenters also complained that after they have 
flagged a verification request as invalid, some sellers try to game the 
system and trigger a passive verification by then repeatedly faxing the 
same verification request to the prescriber in the hopes that the 
prescriber will not have the opportunity to deny the verification 
request again, and it will end up passively verified.\209\
---------------------------------------------------------------------------

    \207\ Driesen (Comment #47); Howe (Comment #53); Cherian 
(Comment #89); Hosaka (Comment #240); Chavez (Comment #334); Ling 
(Comment #390); Redder (Comment #454); Nakasone (Comment #469); Ball 
(Comment #590); Heuer (Comment #467); Ostrom (Comment #489); Hartman 
(Comment #522); Milsky (Comment #559).
    \208\ Sadeghian (Comment #242) (``A number of patients tell me 
that it is common practice by these online contact lens companies to 
tell the consumer to leave [the consumer's] fax number as the 
doctor's fax so nobody would respond to their requests.''); 
Alianiello (Comment #253) (``I asked where he's been buying contact 
lenses and he told me the online avenue he uses asked him for his 
doctor's name, and when he told them he couldn't spell my last name 
they told him to look in the phone book and give them a name of an 
optometrist and they'd take care of it.'').
    \209\ See, e.g., Christensen (Comment #149).
---------------------------------------------------------------------------

    In light of these concerns, some commenters concluded that the 
passive verification system is not working as intended to protect 
patient eye health and instead, recommended that all contact lens 
prescriptions be actively verified.\210\ One commenter recommended that 
the Rule be modified to prevent the shipping of contact lenses without 
active verification.\211\ Another commenter said that if the retailer 
has not received an image of the actual prescription, the seller should 
at least obtain some confirmation that the customer is genuinely a 
patient of the prescriber that is being contacted for 
verification.\212\
---------------------------------------------------------------------------

    \210\ Driscoll (Comment #67); Diaz (Comment #380); Whittington 
(Comment #443).
    \211\ Palmer (Comment #484).
    \212\ Milsky (Comment #559). This commenter also proposed that 
in order to allow eye doctors and the Commission to be able to track 
in detail what happens to online orders after the verification 
request is sent, the seller should be required to inform the 
prescriber whether the transaction was cancelled or completed, and 
if so, what exactly was shipped and when. This mechanism would 
document whether lenses were shipped before any verification took 
place.
---------------------------------------------------------------------------

    The Commission declines to propose these Rule modifications. Issues 
identical to these were raised during the initial rulemaking process in 
2004, when commenters either opposed or expressed significant concern 
about the passive verification system imposed by the Act and the 
Rule.\213\ At that time, some commenters were concerned about the use 
of a passive verification system for prescription medical devices such 
as contact lenses. Other commenters, during the initial rulemaking, 
expressed concern that verification requests could be sent to the wrong 
prescriber and might be improperly filled via passive verification 
because the prescriber neglected to respond to it.\214\
---------------------------------------------------------------------------

    \213\ 69 FR at 40497 and note 206.
    \214\ 69 FR at 40497 and note 198.
---------------------------------------------------------------------------

    The Commission responded to concerns about passive verification by 
finding that ``[b]ecause Congress has decided to impose a passive 
verification system through the Act, whether to adopt a passive 
verification system is not at issue in this rulemaking proceeding.'' 
\215\ The same holds true today, and this rule review does not revisit 
the decision to include a passive verification system.
---------------------------------------------------------------------------

    \215\ 69 FR at 40497.
---------------------------------------------------------------------------

    With respect to concerns that patients are manipulating the passive 
verification system by deliberately providing inaccurate prescriber 
information, the Commission notes that if prescribers receive 
verification requests for individuals who are not their patients, 
prescribers have the ability and incentive to respond that such 
requests are ``invalid'' under section 315.5(d) of the Rule,\216\ thus 
preventing an improper passive verification.
---------------------------------------------------------------------------

    \216\ Id.
---------------------------------------------------------------------------

    With regard to concerns that patients are deliberately providing 
fictional prescriber information and fictional contact information, 
commenters produced only anecdotal evidence of such actions, and did 
not provide empirical data regarding the frequency of these activities. 
Although it is possible that such activities could allow some patients 
to obtain contact lenses without a valid prescription, the Commission 
notes that in doing so, such individuals are intentionally 
circumventing the Rule. As discussed above, the passive verification 
framework has been mandated by Congress in an effort to balance the 
interests of consumer health and prescription portability. At the time 
the Act was under consideration, Congress was aware--after being 
informed by the Commission and the American Optometric Association, 
among others--that passive verification was not a foolproof method for 
preventing the verification of invalid prescriptions.\217\ The 
Commission will consider consumer education efforts designed to 
encourage consumers to act responsibly,

[[Page 88544]]

within the confines of the Rule. In addition, to the extent that the 
Commission receives evidence that sellers are encouraging consumers to 
provide inaccurate or fictional prescriber information, the Commission 
will investigate such allegations, as appropriate.
---------------------------------------------------------------------------

    \217\ See, e.g., ``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) (Testimony of J. Pat Cummings, American 
Optometric Association) (testifying that ``the problem with passive 
verification'' is that some people will be able to get contact 
lenses without a prescription); id. (Testimony of Howard J. Beales, 
Federal Trade Commission) (noting that passive verification contains 
a risk that some contact lenses will be provided based on out-of-
date prescriptions). Congress opted for passive verification after 
hearing repeated reports of the difficulties consumers confronted 
having prescriptions verified in states with active verification 
systems. See H.R. Report No. 108-318, at 5 (2003) (stating the 
Fairness to Contact Lens Consumers Act ``adopts a passive 
verification system in order to best serve the consumer,'' after 
hearing testimony from consumers and businesses of the ``unusually 
high number of consumer complaints in states that rely on active 
verification schemes.''). See also ``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) (Testimony of Peggy 
Venable, Texas Citizens for a Sound Economy) (testifying that under 
an active verification system in Texas, there was a ``widespread 
practice [by optometrists] of failing to verify the prescription''); 
id. (Testimony of Jonathan C. Coon, 1-800 CONTACTS) (testifying that 
under active verification, 1-800 CONTACTS had to cancel half of all 
orders in Texas due to prescribers' failure to respond to 
verification requests).
---------------------------------------------------------------------------

#2. Issues Regarding the Eight-Business-Hour Window
    Some commenters stated that the current eight-business-hour window 
is a reasonable length of time for prescribers to respond to 
verification requests.\218\ 1-800 CONTACTS, for example, asserted that 
the ``eight business-hour time frame for passive verification gives 
prescribers sufficient time to confirm important health information and 
correct any inaccurate orders without imposing a needless delay on 
consumers who place a premium on quick delivery.'' \219\ As support, 1-
800 CONTACTS stated that last year it cancelled orders worth 
approximately $40 million in response to communications from 
prescribers, and that the ``number of deleted orders and the value of 
sales cancelled demonstrate that prescribers have more than adequate 
time to respond when necessary.'' \220\
---------------------------------------------------------------------------

    \218\ 1-800 CONTACTS (Comment #568). See also Warby Parker 
(Comment #593) (``Passive verification provides prescribers with a 
reasonable opportunity to verify, address or correct an inaccurate, 
invalid or expired prescription without imposing an undue burden on 
the prescriber. Furthermore, it gives the seller a reasonable end-
point at which to proceed with the sale. This ensures that 
prescribers do not thwart patient choice of where to purchase 
contact lenses by failing to verify a prescription and relegating 
the patient back to the prescriber for the ultimate purchase. We 
also believe that eight business hours is a reasonable length of 
time for passive verification.'').
    \219\ Comment #568.
    \220\ Id.
---------------------------------------------------------------------------

    Other commenters, however, argued that the eight-business-hour time 
frame for passive verification does not allow enough time for doctors 
to notify sellers that a prescription is expired, inaccurate, or 
nonexistent. The American Academy of Ophthalmology, for example, stated 
that the eight-business-hour requirement ``is far too short and 
ultimately imposes significant burdens on providers and in many 
instances eliminates a necessary patient safety check.'' \221\ Some 
prescribers noted that their offices are very busy and that eight 
business hours was not enough time to verify prescriptions.\222\ The 
CLAO suggested that eight business hours was insufficient because 
``validation requests arrive with incomplete or erroneous patient 
information complicating the process by which clinical records are 
retrieved.'' \223\ These comments, however, did not quantify how the 
eight-business-hour time frame imposed ``significant burdens'' on 
providers, nor establish that a significant number of prescribers were 
unable to respond to verification requests within eight business hours. 
Commenters similarly failed to provide specific information quantifying 
the frequency of incomplete or incorrect validation requests.
---------------------------------------------------------------------------

    \221\ Comment #611.
    \222\ Tran (Comment #260); Bierwerth (Comment #308); Loerzel 
(Comment #550); Fink-Freeman (Comment #609).
    \223\ CLAO (Comment #572).
---------------------------------------------------------------------------

    Many commenters did not propose a specific extension of time to 
respond to a verification request,\224\ and merely stated that eight 
business hours was not enough. Some commenters did put forth specific 
proposals, such as changing the language to ``eight (8) business hours 
or twenty-four (24) clock hours, whichever is later,'' \225\ doubling 
the length of time to 16 hours,\226\ or extending the verification 
window to at least two business days.\227\ Others suggested providing 
at least 48 to 72 hours,\228\ or two to three business days,\229\ to 
confirm the validity of a prescription. A few commenters suggested that 
increasing the window to 72 hours would alleviate issues that arise 
when verifications are received on Friday, Saturday or Sunday.\230\
---------------------------------------------------------------------------

    \224\ Whittington (Comment #443) (``more than eight hours to 
confirm the RX request''); Heuer (Comment #467) (``reasonable amount 
of time to respond'').
    \225\ Milsky (Comment #559) (``That change would still not 
prevent the situation where, for example, a verification request 
comes in on a holiday weekend and the prescriber's office is closed 
for an extra day off, or when a practice is not open on Wednesdays, 
but at least it would mean that the prescriber would have a little 
more of an opportunity (especially at the beginning or end of the 
workday) to correct any errors in the verification request, before 
the order is shipped and it's too late.'').
    \226\ Kiener (Comment #74); Perala (Comment #315); Diaz (Comment 
#380).
    \227\ CLAO (Comment #572); Koury (Comment #573); Fink-Freeman 
(Comment #609); American Academy of Ophthalmology (Comment #611). 
See also Hua (Comment #45) (recommending an increase to 24 to 48 
hours); Bhadra (Comment #105) (same).
    \228\ Gooderman (Comment #10); Galdamex (Comment #167) (at least 
72 hours); Lin-Dilorinzo (Comment #476); Espy (Comment #587).
    \229\ Voight (Comment #551); Figazolo (Comment #24) (three 
days); Truong (Comment #55) (three days).
    \230\ Yaklich (Comment #364); Raff (Comment #373). See also 
Coalition for Patient Vision Safety (Comment #621).
---------------------------------------------------------------------------

    Having considered these comments, the Commission declines to 
propose a Rule modification lengthening the eight-business-hour 
timeframe during which a prescriber must respond to a verification 
request. Despite comments that the timeframe is too short, the 
Commission believes that the current eight-business-hour time frame is 
adequate for the vast majority of prescribers. Commenters put forth no 
empirical evidence that prescriptions are being improperly verified via 
passive verification due to prescribers not having enough time to 
respond, and cited no compelling changes in the marketplace that would 
justify extending the time frame beyond eight business hours. If 
anything, because of advances in technology, electronic communications, 
and record-keeping, eight business hours is as appropriate, if not more 
so, than when implemented in 2004. As the Commission explained in the 
initial rulemaking, ``Congress recognized that consumers may be harmed 
if they face undue delays in receiving their contact lenses from a 
seller'' and balanced that consideration against the possible harm 
consumers may experience if sellers provide contact lenses based on 
invalid prescriptions.\231\ The Commission has found nothing thus far 
in the record for this rule review proceeding to disturb that 
determination.
---------------------------------------------------------------------------

    \231\ 69 FR at 40482.
---------------------------------------------------------------------------

    In addition to concerns about the time prescribers have to respond, 
some commenters expressed concern about when verification calls are 
placed and received. Some optometrists expressed concern that some 
sellers are exploiting the Rule by placing verification requests after 
hours in order to circumvent the eight-business-hour window.\232\ Other 
prescribers noted with frustration that sellers fax verification 
requests outside of normal business hours, such as in the middle of the 
night or on weekends, thereby making it impossible for them to respond 
in a timely fashion.\233\ Some commenters complained that because they 
only had 24 hours to respond to a

[[Page 88545]]

verification request,\234\ such verifications would be confirmed 
automatically over the weekend because no one was in the office.\235\ 
Other commenters noted that they receive verification faxes outside of 
normal business hours and therefore have no way of verifying, denying, 
or correcting prescriptions.\236\ Many of these commenters recommended 
that the Rule be amended to prohibit sellers from sending prescription 
verifications after business hours and on weekends.\237\ Along the same 
lines, the Coalition for Patient Vision Safety recommended that the 
Commission modify ``the eight-hours of communication when the initial 
communication begins prior to a holiday or on a weekend when the doctor 
is not conducting normal office hours.'' \238\
---------------------------------------------------------------------------

    \232\ Berger (Comment #200) (``[u]nder the current law, 
retailers are allowed to fill a prescription if verification is not 
received within 8 hours. This is commonly exploited by faxing or 
robodialing verification requests outside of normal business hours, 
then filling the prescription before the prescriber responds.''). 
See also Stahl (Comment #19); Lum (Comment #21); Peterson (Comment 
#22); Maanum (Comment #23); Matthews (Comment #25); Borsky (Comment 
#26); Hodes (Comment #42); Dodge (Comment #44); McBride (Comment 
#171); Sloan (Comment #177); Kirkconnell (Comment #202); Hamilton 
(Comment #216); Leach (Comment #257); Chang (Comment #258); Yaklich 
(Comment #364); Leung (Comment #607); Wu (Comment #608); Vidulich 
(Comment #612); Lai (Comment #620); Pechko (Comment #628); Liu 
(Comment #656); Louie (Comment #657); Fong (Comment #669); Vo 
(Comment #673).
    \233\ Plumb (Comment #219); St. Martin (Comment #292); Diaz 
(Comment #380); Witmeyer (Comment #418); Nakasone (Comment #469); 
Garcia (Comment #511); Egbert (Comment #515); Steinleitner (Comment 
#517).
    \234\ Whipple (Comment #15); Huang (Comment #17); Wilson 
(Comment #76); Green (Comment #162); Frederick (Comment #207); Zair 
(Comment #512).
    \235\ Magee (Comment #95); Mueller (Comment #513); Born (Comment 
#570); Shugarman (Comment #266).
    \236\ Glavine (Comment #62); Tolchin (Comment #194); Bricker 
(Comment #195); Ahn (Comment #215); Lester (Comment #231); Kegarise 
(Comment #447).
    \237\ California Optometric Association (Comment #119); Stahl 
(Comment #19); Lum (Comment #21); Peterson (Comment #22); Maanum 
(Comment #23); Matthews (Comment #25); Borsky (Comment #26); Chriqui 
(Comment #31); Hodes (Comment #42); Dodge (Comment #44); Loydall 
(Comment #225); Leach (Comment #257); Chang (Comment #258); Liebig 
(Comment #478); Harris (Comment #490); Leung (Comment #607); Wu 
(Comment #608); Vidulich (Comment #612); Lai (Comment #620); Pechko 
(Comment #628); Liu (Comment #656); Louie (Comment #657); Fong 
(Comment #669); Vo (Comment #673).
    \238\ Comment #621. Similarly, some commenters suggested 
increasing the eight-business-hour window because, based on their 
apparent misunderstanding of how the eight business hours are 
calculated, they believed that they did not have enough time to 
respond to verification requests received after business hours and 
on weekends. See Mirkin (Comment #111); Kalman (Comment #150); 
Bender (Comment #164); Hans (Comment #168); Baur (Comment #170; 
Yaklich (Comment #364); Raff (Comment #373); Diaz (Comment #380); 
Kegarise (Comment #447); Heuer (Comment #467); Zair (Comment #512); 
Gandhi (Comment #588).
---------------------------------------------------------------------------

    At this time, the Commission does not propose to amend the Rule to 
prohibit sellers from sending prescription verification requests after 
business hours and on weekends or to otherwise extend the eight-
business-hour window to account for weekends and holidays. It appears 
that the majority of commenters suggesting this prohibition are 
concerned that they do not have the opportunity to verify a 
prescription because they believe the eight-business-hour window for 
verification of a contact lens order is triggered upon receipt of a 
verification request, no matter when that request is received. That 
concern is misplaced. Section 315.2 of the Rule provides that ``[f]or 
verification requests received by a prescriber during nonbusiness 
hours, the calculation of `eight (8) business hours' shall begin at 9 
a.m. on the next weekday that is not a Federal holiday or, if 
applicable, on Saturday at the beginning of the prescriber's actual 
business hours.'' \239\
---------------------------------------------------------------------------

    \239\ See also 69 FR at 40486.
---------------------------------------------------------------------------

    Other commenters expressed frustration that verification requests 
were sent after regular business hours with the statement that the 
prescription would be filled unless the prescriber contacted the seller 
within 12 to 24 hours.\240\ Depending upon when these requests are 
sent, these sellers' practices could result in contact lenses being 
shipped before or after the end of the eight-business-hour window. To 
the extent that sellers are dispensing contact lenses prior to the end 
of the eight-business-hour window, the Commission notes that this 
practice violates the Rule. If the Commission receives evidence that 
sellers are dispensing contact lenses before the end of the eight-
business-hour window, the Commission will investigate such allegations, 
as appropriate.
---------------------------------------------------------------------------

    \240\ Huang (Comment #17); Magee (Comment #95); Green (Comment 
#162); Shugarman (Comment #266).
---------------------------------------------------------------------------

    A few commenters expressed concern that some prescriptions were 
being automatically filled without a prescriber's oversight because the 
calculation of an eight-business-hour window does not take into 
consideration the fact that their offices may not be open or able to 
verify prescriptions during the Rule's established timeframe for 
business hours.\241\ For example, an office may be closed due to 
vacation, inclement weather, or regularly scheduled office closures 
that occur during the normal workweek.\242\
---------------------------------------------------------------------------

    \241\ A small number of commenters complained that they 
regularly received verification requests from sellers that state 
that their records indicate that the prescriber has Saturday 
business hours. See Alianiello (Comment #253); Raff (Comment #373). 
These commenters said that despite correcting this misimpression, 
the seller continued to send verification requests that would begin 
the eight-business-hour window on Saturday morning. The Commission 
reiterates that this is a Rule violation because the seller only may 
count Saturday hours as business hours if the seller has actual 
knowledge of the prescriber's Saturday business hours. Here, the 
seller has actual knowledge to the contrary. 69 FR at 40485. If the 
Commission receives evidence of such practices, the Commission will 
investigate such allegations, as appropriate.
    \242\ Robins (Comment #165); Glassband (Comment #218); Kubo 
(Comment #234); Whang (Comment #355); Makler (Comment #356); Falcon 
(Comment #505); Manuel (Comment #508); Voight (Comment #551); Koury 
(Comment #573); Kowaleski (Comment #578).
---------------------------------------------------------------------------

    Similar concerns were raised by commenters in the initial 
rulemaking in 2004. At that time, the Commission declined to adopt an 
actual hours or other prescriber-specific approach to business hours, 
noting that ``[i]t likely would be difficult and burdensome--perhaps 
impossible--for some sellers to determine and keep track of the actual 
hours of 50,000 prescribers. By contrast, a general rule using a 
uniform definition of business hours for all prescribers provides 
clarity and relative ease of compliance and enforcement.'' \243\ In 
addition, the Commission recognized that there ``does not appear to be 
any practical way to accommodate the myriad circumstances during which 
the offices of 50,000 individual prescribers may be closed or otherwise 
not able to respond to a prescription verification request.'' \244\ The 
Commission continues to believe that such an approach would be 
impractical and declines to propose an actual hours or other 
prescriber-specific approach to calculating business hours.
---------------------------------------------------------------------------

    \243\ 69 FR at 40484.
    \244\ Id.
---------------------------------------------------------------------------

V. Contact Lens Prescriptions

A. Section 315.6--Expiration of Contact Lens Prescriptions

    As set forth by Section 315.6(a) of the Rule, a contact lens 
prescription expires 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.\245\ If State law specifies 
no date or specifies a date less than one year after the issue date of 
the prescription, the Rule provides that the prescription shall not 
expire less than one year after the issue date of the 
prescription.\246\ A prescriber, nonetheless, can specify a shorter 
expiration date if that date is ``based on the medical judgment of the 
prescriber with respect to the ocular health of the patient.'' \247\ 
The prescriber then must document the reasons in the patient's medical 
record.\248\ In other words, contact lens prescriptions cannot expire 
in less than one year unless, based on medical judgment, a prescriber 
specifies a different date and documents the

[[Page 88546]]

reasoning. The language of these Rule provisions closely tracks that of 
the Act.\249\
---------------------------------------------------------------------------

    \245\ 16 CFR 315.6(a)(1). The majority of states require that a 
contact lens prescription not expire less than one year after the 
issue date, except when a special medical circumstance necessitates 
that it expire sooner. A few states, such as Maryland and 
Washington, require that contact lens prescriptions not expire less 
than two years after the issue date except for special medical 
circumstances. See, e.g., Maryland Code Sec.  11-404.4; Wash. Admin. 
Code Sec.  246-852-010 (1)(f).
    \246\ 16 CFR 315.6(a)(2).
    \247\ 16 CFR 315.6(a)(3).
    \248\ 16 CFR 315.6(b)(1).
    \249\ 15 U.S.C. 7604.
---------------------------------------------------------------------------

1. Length of Contact Lens Prescriptions
    The Commission received several comments about the length of 
contact lens prescriptions. Some commenters expressed the view that the 
prescription length should be longer. For example, Consumers Union 
requested that the Commission ``consider whether a longer minimum 
period is warranted in the best interests of the consumer.'' \250\ One 
consumer commented that contact lens prescriptions should be at least 
two years in length.\251\
---------------------------------------------------------------------------

    \250\ Comment #677.
    \251\ Schodowski (Comment #65).
---------------------------------------------------------------------------

    The Professional Opticians of Florida recommended that the 
Commission modify the Rule to prohibit the use of expiration dates on 
prescriptions for adult patients with low risk factors,\252\ while an 
optometrist argued that, ``[c]ompetition for the sales of contact 
lenses is so great that placing any regulations on the length of the 
prescription is unnecessary and should be at the sole discretion of the 
prescriber.'' \253\ LD Vision Group, a contact lens retailer, declared 
that while it generally makes sense for patients to undergo a 
comprehensive eye examination to ensure good eye health, patients 
should not have to undergo a follow-up contact lens fitting after 
receiving a trial pair of contact lenses from a prescriber.\254\ 
Furthermore, according to that commenter, patients should be able to 
waive the requirement that their contact lens prescriptions be 
verified--and yet still be able to obtain contact lenses--by 
acknowledging that they are aware of the risks of not obtaining an 
annual eye examination.\255\
---------------------------------------------------------------------------

    \252\ Comment #563.
    \253\ Bolenbaker (Comment #357).
    \254\ LD Vision Group (Comment #544).
    \255\ Id.
---------------------------------------------------------------------------

    However, many commenters, primarily prescribers, urged the 
Commission not to ``deregulate'' prescription length \256\ or otherwise 
extend the length of contact lens prescriptions.\257\ Other prescribers 
encouraged the Commission to retain the one-year prescription length, 
citing the importance of annual eye examinations for preventing 
complications related to contact lens use, diagnosing other conditions 
by examining the eyes, and providing patient education about contact 
lens use.\258\ A few commenters expressed satisfaction with the two-
year prescription length imposed by some States' laws.\259\
---------------------------------------------------------------------------

    \256\ Wood (Comment #37); Compton (Comment #275); Singhai 
(Comment #281).
    \257\ See, e.g., Morgan (Comment #144); Stoliker (Comment #286); 
Parikh (Comment #288); Shlosman (Comment #290); Lee (Comment #293); 
Paulsen (Comment #296); Turano (Comment #303); Yang (Comment #307); 
Daniel (Comment #310); Huynh (Comment #313); Stetson (Comment #314); 
Theroux (Comment #317); Wong (Comment #330); Tarr (Comment #344); 
Peres-Maes (Comment #346); Dronka (Comment #347);Scott (Comment 
#354); Cantor (Comment #358); Cesar (Comment #359); Philippe 
(Comment #365); Geller (Comment #370); Uchida (Comment #403); Sharma 
(Comment #404): Nguyen (Comment #412); Eng (Comment #414); Frady 
(Comment #440); Santhanam (Comment#444); Calhoun (Comment #446); 
Howard (Comment #453); Desai (Comment #462); Douglas (Comment #526); 
Geiger (Comment #598); Ancona (Comment #650); Webster (Comment 
#670).
    \258\ See, e.g., Coalition for Patient Vision Care Safety 
(Comment #621);Williford (Comment #38); Kapoor (Comment #58); 
Anderson (Comment #96); Tse (Comment #146); Morrison (Comment #239); 
Major (Comment #263); Uy (Comment #277); Williams (Comment #261); 
Walker (Comment #283); Murray (Comment #287); Rice (Comment #295); 
Harris (Comment #305); Cluff (Comment #309); Hollister (Comment 
#318); Oliver (Comment #323); Gelman (Comment #326); Cox (Comment 
#336); Zimmerman (Comment #372); Sherman (Comment #375); Klein 
(Comment #377); Hafford (Comment #383); Blankenship (Comment #395); 
Elmore (Comment #396); Assell (Comment #397); Yaryan (Comment #401); 
Stefanovic (Comment #417); Enochs (Comment #423); Moore (Comment 
#437); Archibald (Comment #438); Lott (Comment #445); Goller 
(Comment #448); Eggers (Comment #473); Abbott (Comment #497); 
Nazario (Comment #518); Neuenfeldt (Comment #542); Maino (Comment 
#555); Bieter (Comment #602); Lac (Comment #631); Bandy (Comment 
#643); Lee (Comment #659); Alexander (Comment #666).
    \259\ Hua (Comment #45); Campbell (Comment #348).
---------------------------------------------------------------------------

    The Commission declines to propose any changes--either removing or 
lengthening--the Rule's prescription length provisions. As indicated 
above, the Rule's language closely tracks that of the Act, which set a 
minimum expiration date ``to prevent prescribers from selecting a short 
expiration date for a prescription that unduly limits the ability of 
consumers to purchase contact lenses from other sellers, unless medical 
reasons justify setting such an expiration date.'' \260\ Accordingly, 
the Commission is not at liberty to remove the prescription expiration 
provision. In addition, the Commission declines to propose to lengthen 
the Rule's prescription expiration provisions and believes the current 
framework is appropriate. As the Commission concluded in response to 
commenters arguing for a minimum expiration date of two years during 
the initial rulemaking, in drafting the Act, Congress intended to defer 
to applicable State law except where such law establishes an expiration 
period of less than one year.\261\
---------------------------------------------------------------------------

    \260\ 69 FR at 40504; 69 FR at 5443.
    \261\ 69 FR at 40504.
---------------------------------------------------------------------------

2. Expired Contact Lens Prescriptions
    A number of prescribers reported that some of their patients are 
obtaining contact lenses through online vendors even though their 
contact lens prescriptions have expired.\262\ According to Johnson & 
Johnson Vision Care, Inc., ``roughly one-in-three online contact lens 
purchasers'' surveyed in a 2015 APCO Insight online survey ``admit[ted] 
to ordering lenses using an already expired prescription.'' \263\ In 
response to these concerns, some commenters recommended that the 
Commission amend the Rule specifically to prohibit the sale of contact 
lenses to patients with expired prescriptions.\264\
---------------------------------------------------------------------------

    \262\ See, e.g., Williford (Comment #38); Glavine (Comment #62); 
Jones (Comment #63); Copeland (Comment #73); Weinberg (Comment #87); 
Moody (Comment #92); Buthod (Comment #81); Kreda (Comment #93); 
Magee (Comment #95); Voreis (Comment #114); Navarro (Comment #117); 
Taylor (Comment #120); Dyak (Comment #124); Stewart (Comment #136); 
Madden (Comment #155); Robertson (Comment #180); Chakuroff (Comment 
#189); Law (Comment #190); Burruss (Comment #192); Bricker (Comment 
#195); Stephens (Comment #210); Sadeghian (Comment #242); Pentecost 
(Comment #268); Shaw (Comment #339); Chea (Comment #352); 
Steinleitner (Comment #517); Holler (Comment #553); Song (Comment 
#654).
    \263\ Comment #582 (emphasis deleted). The survey, conducted on 
behalf of Johnson & Johnson Vision Care, Inc. included 500 contact 
lens users 18 years of age or older who had purchased contacts 
online in the prior six months. See also Coalition for Patient 
Vision Care Safety (Comment #621) (referencing 2015 APCO Insight 
Survey).
    \264\ Stahl (Comment #19); Lum (Comment #21); Peterson (Comment 
#22); Maanum (Comment #23); Matthews (Comment #25); Borsky (Comment 
#26); Chriqui (Comment #31); Hodes (Comment #42); Dodge (Comment 
#44); Ellingson (Comment #66); Leach (Comment #257); Chang (Comment 
#258); Leung (Comment #607); Wu (Comment #608); Vidulich (Comment 
#612); Lai (Comment #620); Pechko (Comment #628); Liu (Comment 
#656); Louie (Comment #657); Fong (Comment #669); Vo (Comment #673).
---------------------------------------------------------------------------

    After reviewing the comments, the Commission has determined that no 
amendment is necessary because the current regulatory framework 
sufficiently prohibits the use of expired prescriptions. As a threshold 
matter, Section 4(e) of the Act and Section 315.5(d) of the Rule 
clearly identify three categories of invalid prescriptions (inaccurate, 
expired, and otherwise invalid).\265\ Accordingly, the Act and the Rule 
already make explicit that an expired prescription is not a valid 
prescription. Under the Rule, sellers may only dispense lenses using 
either a prescription that has been presented to the seller, or a 
prescription that has been verified with the prescriber by the 
seller.\266\ A prescription presented to the

[[Page 88547]]

seller must contain an expiration date in order to satisfy the 
definition of contact lens prescription.\267\ If the prescription 
presented to, or in possession of, the seller is expired, that 
prescription is invalid and the seller cannot use the expired 
prescription to dispense lenses to the patient. Because the seller has 
actual knowledge that the prescription is expired, neither may the 
seller use the expired prescription as the basis for a passive 
verification request. If, however, a seller has been presented with, or 
is in possession of, a prescription that does not contain an expiration 
date, or is otherwise relying on prescription information provided by 
the patient, then the seller may proceed to verify such prescription 
with the prescriber.\268\ In this latter instance, the seller does not 
have any knowledge as to whether or not the prescription is expired, 
and can rely on the prescriber to alert the seller if the prescription 
is expired.
---------------------------------------------------------------------------

    \265\ 15 U.S.C. 7603(e); 16 CFR 315.5(d). See also 69 FR at 
40502.
    \266\ 16 CFR 315.5(a).
    \267\ 16 CFR 315.2.
    \268\ 16 CFR 315.5(a)(2).
---------------------------------------------------------------------------

    Other commenters, recognizing that selling contact lenses on an 
expired prescription is not allowed by the Rule, instead urged the 
Commission to increase enforcement.\269\ The Commission believes that 
the clarification regarding expired prescriptions as set forth in this 
document will assist sellers in understanding their obligations under 
the Rule. In addition, if the Commission receives evidence that sellers 
are dispensing contact lenses based on expired prescriptions, the 
Commission will investigate such allegations, as appropriate.
---------------------------------------------------------------------------

    \269\ See, e.g., Peterson (Comment #222); Smith (Comment #319); 
Heuer (Comment #467); Santarias (Comment #471); Johnson & Johnson 
Vision Care, Inc. (Comment #582) (``critical to ensure patients 
continue to see their eye care professionals for their annual check-
up and prescription renewal by upholding and enforcing the one-year 
contact lens prescription expiration date''); Coalition for Patient 
Vision Care Safety (Comment #621).
---------------------------------------------------------------------------

    Other commenters explained that because of flaws in the passive 
verification system sellers ``can request verification of an otherwise 
expired prescription and can ship the lenses if the prescriber does not 
recognize within eight business hours that the expiration date has 
passed and inform the seller.'' \270\ In its comment, the Contact Lens 
Association of Ophthalmologists argued that passive verification 
``creates a mechanism for renewal of expired prescriptions, which is in 
the seller's interest, may be in the consumer's immediate interest, but 
is not in the interest of the consumer's long term ocular health.'' 
\271\
---------------------------------------------------------------------------

    \270\ American Optometric Association (Comment #644). See also 
Stewart (Comment #136) (stating that expired prescriptions have been 
filled for years because there was no reply to passive 
verification).
    \271\ Comment #572. See also American Optometric Association 
(Comment #644) (``[a]llowing repurchases based on long-expired 
prescriptions may be, at the time, convenient for the patient and 
profitable for the seller, but increases the risk of patient 
harm'').
---------------------------------------------------------------------------

    In its comment, the American Optometric Association noted that ``an 
expiration date and issue date are required elements of a 
prescription'' and the FTC ``should require the expiration date or 
issue date to be provided in prescription verification.'' \272\ This 
commenter argued that this requirement would incentivize sellers to 
make sure patients know their prescription expiration date when placing 
orders. The American Optometric Association further explained that 
because sellers often market to consumers to reorder in the final month 
or weeks that the prescription is valid, it believes that sellers 
already know the prescription expiration date.\273\ This commenter 
concluded that by requiring the expiration date or issue date in the 
verification request, sellers would be aware, and could not deny when 
they are using an invalid prescription.\274\
---------------------------------------------------------------------------

    \272\ American Optometric Association (Comment #644).
    \273\ Id.
    \274\ Id.
---------------------------------------------------------------------------

    The Commission declines to propose that the Rule be modified in 
this way. Similar proposals were suggested and rejected during the 
initial rulemaking.\275\ As the Commission recognized at that time, 
there is ``no reason to believe or evidence to suggest that a seller 
who is attempting to verify a prescription would necessarily have this 
information.'' \276\ Furthermore, the Commission believes that adopting 
such a proposal might thwart the intent of the Act. For example, 
although prescribers themselves have the prescription expiration 
information because they issued the prescription, a seller verifying a 
prescription--as opposed to a seller who has a copy of a prescription 
with an expiration date--may not have access to this information. 
Because a verification request that does not contain all the required 
information is not a valid verification request,\277\ sellers without 
expiration information would be at a disadvantage in that they would 
not be able to verify patient prescriptions based on Section 
315.5(c)(3). Furthermore, as noted, prescribers are already in 
possession of the expiration date, and it is in their economic and 
professional interest to check the prescriptions and respond to 
verification requests by informing the seller whenever a prescription 
has expired.\278\
---------------------------------------------------------------------------

    \275\ A state optometry association requested that the Rule be 
amended to require the verification request to contain the 
prescription's expiration date as well as the number of refills 
prescribed. 69 FR at 40496.
    \276\ Id.
    \277\ Id. (``The Commission emphasizes that the sale of contact 
lenses based on a verification request which does not contain all of 
the required information constitutes a Rule violation.'').
    \278\ 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) (Testimony of Howard Beales, Federal Trade 
Commission) (noting that passive verification is ``in many respects 
self-enforcing'').
---------------------------------------------------------------------------

    For the same reasons, the Commission declines to propose to amend 
the Rule to reflect the American Optometric Association's proposal ``to 
ban sellers from marketing to specific customers to reorder their 
lenses after the prescription has expired (more than one year after the 
issue date or when the customer originally ordered lenses from the 
seller) unless the seller has specific knowledge the customer's 
prescription is valid for more than one year.'' \279\ To the extent a 
patient does not have a valid prescription, the Rule already prohibits 
the sale of contact lenses. However, nothing in the Act supports the 
extension of this prohibition to the marketing (as opposed to the sale) 
of contact lenses. It may be in the patient's best interest to receive 
a reminder to reorder lenses. If the patient does not have a valid 
prescription, the seller is prohibited from selling the lenses. 
However, if the patient has visited a prescriber in the interim, the 
patient will have a valid prescription and the sale can be made.
---------------------------------------------------------------------------

    \279\ American Optometric Association (Comment #644).
---------------------------------------------------------------------------

3. Quantities of Contact Lenses Obtained by Patients
    Many commenters expressed the concern that because of inadequacies 
in the Rule or lack of enforcement, consumers are able to obtain more 
than a year's supply of contact lenses.\280\ For example, some 
commenters asserted that this occurs because some contact lens 
retailers allow patients to purchase

[[Page 88548]]

more than a year's supply of contact lenses,\281\ while other 
prescribers reported that patients are able to refill their contact 
lenses prescription and obtain more lenses just prior to the 
prescription expiring.\282\ Prescribers also were concerned that they 
were receiving verification requests from sellers for contact lenses 
just as the patient's prescription was expiring.\283\ A number of 
commenters complained that contact lens sellers are actively 
encouraging patients to refill their prescriptions right before they 
expire.\284\ For example, one commenter reported that sellers ``send 
reminders to patients about a month before their contact lens 
prescription is expired, to buy another whole year's prescription.'' 
\285\ One contact lens manufacturer reported that an online survey that 
it had commissioned showed that 58% of the online consumers that were 
surveyed indicated that they had received an email or letter from their 
retailer reminding them that their prescription was expiring soon and 
that the majority of these consumers had ordered more lenses as a 
result.\286\ Other commenters noted that patients are able to obtain 
more than a year's supply of contact lenses by ordering from multiple 
sources.\287\
---------------------------------------------------------------------------

    \280\ See, e.g., Rohleder (Comment #57) (``Because of lack of 
enforcement, patients are able to purchase more contact lenses than 
they can use in a year, thus allowing them to circumvent seeing 
their doctor almost indefinitely.''); Filandro (Comment #129) (``A 
patient can order ten years' worth of contacts and can't be stopped 
by the law. A patient can order one years' [sic] worth of contacts 
from ten different vendors and can't be stopped by the law.''); 
Stewart (Comment #136) (``Patients are able to purchase multi-years 
[sic] worth of contact lenses even though the prescription clearly 
states expires in one year.''); Tjandera (Comment #502) (noting that 
the Rule can be evaded because patients can order from multiple 
online retailers before the prescription expires).
    \281\ Young (Comment #91); Anklin (Comment #107); American 
Optometric Association (Comment #644).
    \282\ Day (Comment #4); Driesen (Comment #47); Schwartz (Comment 
#80); Magee (Comment #95); Johnson (Comment #109); Rosemore (Comment 
#468); Garcia (Comment #511). See also Milsky (Comment #559) 
(``Another common concern among prescribers is, for example, a 
prescription for a year's supply of contact lenses getting filled 
one month before it expires, eleven months after the exam and 
fitting.'').
    \283\ Shin (Comment #70); Young (Comment #91); Chakuroff 
(Comment #189); Koury (Comment #573).
    \284\ Mathai (Comment #33) (``1800 contacts and other retailers 
prompt their customers to purchase an annual supply right before 
their prescription expires so they can save a trip to their Dr [sic] 
office.''); Jones (Comment #83) (``Contact lens suppliers are 
actively targeting patients to get them to order outside the limits 
of the prescription and/or fishing for patient information.''); 
Young (Comment #91) (``Some online retailers are actively marketing 
to consumers to purchase more contact lenses when their prescription 
is `about to expire'.''); Nelson (Comment #130) (``1-800 Contacts 
also will not respect a number of refills on the Rx. Instead, they 
will email the patient before their Rx expires and tell them to 
order more. Patients then order another year of contacts and then 
cancel their yearly examination.''); Hans (Comment #168) (patients 
prompted to save trip to doctor's office); Ellenberger (Comment 
#272) (same); Gandy (Comment #530) (stop sellers from aggressive and 
unethical practice of encouraging patients to buy another years' 
supply of lenses right before their prescription expires); Tass 
(Comment #586) (same).
    \285\ Combs (Comment #90).
    \286\ Johnson & Johnson Vision Care, Inc. (Comment #582) 
(``nearly six-in-ten online consumers say they have received an 
email or letter from their retailer reminding them their Rx was 
expiring soon (58%) and the vast majority who received this notice 
(86%) ordered more contacts as a result'').
    \287\ Jones (Comment #83); Filandro (Comment #129); Heuer 
(Comment #467); Endry (Comment #552); Milsky (Comment #559).
---------------------------------------------------------------------------

    As explained by other commenters, if patients can obtain lenses in 
excess of a year's supply, expiration dates on prescriptions become 
meaningless \288\ and patients do not return to their eye care 
professional on an annual basis.\289\ Some prescribers provided 
anecdotal reports of patients not returning for an annual eye exam, 
sometimes for several years, because they had been able to purchase 
contact lenses online.\290\
---------------------------------------------------------------------------

    \288\ Mirkin (Comment #111); Endry (Comment #552). See also 
Harris (Comment #490) (purchasing contacts right before the 
prescription expires defeats the purpose of annual expiration dates 
and the monitoring of patient eye health).
    \289\ See, e.g., Rohleder (Comment #57); Buthod (Comment #81); 
Moody (Comment #92); Anklin (Comment #107); Nett (Comment #449); 
Lisenby (Comment #662).
    \290\ See, e.g., Weissman (Comment #50) (five years); Grace 
(Comment #64) (several years); Buthod (Comment #81) (3-5 years); 
Patel (Comment #188) (companies filling prescriptions for 10 years 
without successful verification); Pentecost (Comment #268); Silani 
(Comment #270) (returning for an exam ``years'' later); Chea 
(Comment #352); Arthur (Comment #371) (five years); Hornberger 
(Comment #457) (as many as five years); Pickering (Comment #475) 
(four to five years); Born (Comment #570) (many years); Gronquist 
(Comment #630) (years).
---------------------------------------------------------------------------

    To address these concerns, a number of commenters--optometric and 
ophthalmologic associations, individual prescribers, and contact lens 
manufacturers--proposed that the Commission amend the Rule to require 
contact lens prescriptions to include a maximum quantity of lenses that 
consumers can purchase prior to the prescription's expiration.\291\ 
These commenters asserted that including a quantity limit on 
prescriptions would be beneficial to patients' health and safety.\292\ 
One contact lens manufacturer stated that quantity limits ``impose 
important safeguards and also strengthen the prescriber-patient 
relationship,'' arguing that if a patient runs out of contact lenses, 
this would ``offer[] yet another opportunity for consumers to ask 
questions, share health and other issues they may be encountering with 
their lenses, or adjust their prescription under the supervision of an 
eye care professional.'' \293\
---------------------------------------------------------------------------

    \291\ American Optometric Association (Comment #644); American 
Academy of Optometry (Comment #623); Virginia Optometric Association 
(Comment #16); Wisconsin Optometric Association (Comment #30); Utah 
Optometric Association (Comment #39); Pennsylvania Optometric 
Association (Comment #46); Alabama Optometric Association (Comment 
#48); Iowa Optometric Association (Comment #79); Michigan Optometric 
Association (Comment #86); California Optometric Association 
(Comment #119); New Mexico Optometric Association (Comment #211); 
Mississippi Optometric Association (Comment #548); Ohio Optometric 
Association (Comment #556); Connecticut Association of Optometrists 
(Comment #560); North Carolina State Optometric Society (Comment 
#567); Tennessee Association of Optometric Physicians (Comment 
#575); Colorado Optometric Association (Comment #584); New Jersey 
Society of Optometric Physicians (Comment #595); Coalition for 
Patient Vision Care Safety (Comment #621); Stahl (Comment #19); Lum 
(Comment #21); Peterson (Comment #22); Maanum (Comment #23); 
Matthews (Comment #25); Borsky (Comment #26); Chriqui (Comment #31); 
Hodes (Comment #42); Dodge (Comment #44); Kapoor (Comment #58); 
Comer (Comment #221); Leach (Comment #257); Chang (Comment #258); 
Whang (Comment #355); Knight (Comment #360); Senator Perdue (Comment 
#569); Reed (Comment #579); Johnson & Johnson Vision Care, Inc. 
(Comment #582); Leung (Comment #607); Wu (Comment #608); Vidulich 
(Comment #612); Lai (Comment #620); Pechko (Comment #628); Liu 
(Comment #656); Louie (Comment #657); Fong (Comment #669); Vo 
(Comment #673).
    \292\ See, e.g., American Optometric Association (Comment #644).
    \293\ Johnson & Johnson Vision Care, Inc. (Comment #582).
---------------------------------------------------------------------------

    In addition to including the maximum quantity on the prescription 
itself, several state optometric associations also recommended that the 
Commission ``limit the number of contact lens boxes that can be 
purchased from a retailer at one time.'' \294\ Similarly, the Coalition 
for Patient Vision Care Safety proposed that the Commission ``forbid 
retailers to sell in a single transaction a quantity of contact lenses 
that exceeds a single year's supply.'' \295\ As an alternative, the 
Coalition suggested the Commission require that sellers only provide a 
supply equal to the length of the underlying prescription.\296\ A few 
commenters stated that because passive verification might allow the 
consumer to obtain more lenses than medically prescribed, quantity 
limits should be considered.\297\
---------------------------------------------------------------------------

    \294\ Virginia Optometric Association (Comment #16); Wisconsin 
Optometric Association (Comment #30); Utah Optometric Association 
(Comment #39); Pennsylvania Optometric Association (Comment #46); 
Alabama Optometric Association (Comment #48); Iowa Optometric 
Association (Comment #79); Michigan Optometric Association (Comment 
#86); California Optometric Association (Comment #119); New Mexico 
Optometric Association (Comment #211); Mississippi Optometric 
Association (Comment #548); Ohio Optometric Association (Comment 
#556); Connecticut Association of Optometrists (Comment #560); North 
Carolina State Optometric Society (Comment #567); Tennessee 
Association of Optometric Physicians (Comment #575); Colorado 
Optometric Association (Comment #584); New Jersey Society of 
Optometric Physicians (Comment #595).
    \295\ Comment #621.
    \296\ Id. See also Dierks (Comment #32); Ellingson (Comment 
#66); Moody (Comment #92); Bhadra (Comment #105); Rana (Comment 
#139); Patel (Comment #237); Santry (Comment #529).
    \297\ Wilson (Comment #76) (passive verification allows the 
contact lens seller to sell the patients more lenses than are 
medically prescribed); Kline (Comment #161) (same); Johnson & 
Johnson Vision Care, Inc. (Comment #582).
---------------------------------------------------------------------------

    A number of commenters argued that contact lens prescriptions 
should be

[[Page 88549]]

treated the same way as pharmaceutical prescriptions in order to 
prevent the dispensing of excess quantities.\298\ As described by one 
commenter, this would require the quantity to be included on the 
prescription and the retention of the prescription by the dispenser 
filling it.\299\ A few commenters suggested a pro rata approach. For 
example, one prescriber recommended that consumers should only be able 
to obtain refills commensurate with the amount of time left on the 
prescription.\300\ Likewise, the Coalition for Patient Vision Safety 
proposed a similar approach, suggesting that the Commission ``restrict 
the sale of contact lenses on a prescription that is nine months after 
issuance or older to up to 25 percent of the prescription's course.'' 
\301\ One contact lens manufacturer recommended that the Commission 
modify the Rule to ``place[] reasonable limits on the quantity of 
contact lenses a patient can purchase under a prescription (especially 
within a few months of a prescription expiring)'' in order to encourage 
patients to go to their eye care professional for routine 
examinations.\302\
---------------------------------------------------------------------------

    \298\ See, e.g., Filandro (Comment #129); Kalman (Comment #150); 
Bainbridge (Comment #152); Anderson (Comment #185); Palermo (Comment 
#212); Sanders (Comment #235); Sanders (Comment #236); Smith 
(Comment #319); Chesen (Comment #350); Perichak (Comment #415); 
Witmeyer (Comment #418); Palmer (Comment #484); Pierzchala (Comment 
#500); Haefs (Comment #525); Johnson & Johnson Vision Care, Inc. 
(Comment #582); Tass (Comment #586); Ball (Comment #590); Alexander 
(Comment #666).
    \299\ Kalman (Comment #150).
    \300\ See, e.g., Milsky (Comment #559).
    \301\ Comment #621.
    \302\ CooperVision, Inc. (Comment #591).
---------------------------------------------------------------------------

    However, other commenters disagreed with the proposal to include 
quantity limits on contact lens prescriptions. 1-800 CONTACTS argued 
that imposing quantity limits would ``inconvenience consumers and lead 
to unhealthy practices, such as wearing lenses longer than 
recommended.'' \303\ This commenter asserted that patients could 
misplace or tear lenses, or might replace their lenses more frequently 
than anticipated by their prescription, and consequently concluded that 
``there are any number of very legitimate reasons a consumer may want 
to purchase what appear to be (based on simple multiplication) extra 
lenses and there is no valid reason to restrict that consumer's 
options.'' \304\
---------------------------------------------------------------------------

    \303\ Comment #568.
    \304\ Id.
---------------------------------------------------------------------------

    Another contact lens retailer claimed that prescribers were 
circumventing the minimum one-year expiration period by ``limit[ing] 
the quantity of replacement lenses, despite the lack of any medical 
reason for ever doing so'' and that ``a consumer's need for additional 
lenses could arise for a number of reasons.'' \305\ This commenter 
proposed that the Commission amend Section 315.6 of the Rule to include 
a provision stating that a ``contact lens prescription shall be valid 
for an unlimited quantity of lenses regardless of any prescriber-
imposed limitation to the contrary.'' \306\
---------------------------------------------------------------------------

    \305\ LD Vision Group (Comment #544).
    \306\ Id.
---------------------------------------------------------------------------

    After reviewing the comments, the Commission has determined not to 
propose to amend the Rule to adopt any of the contact lens quantity 
proposals put forth by commenters. First, the Commission does not 
believe that there is sufficient evidence in the rulemaking record to 
support amending the Rule to impose the quantity limit proposals 
suggested by commenters. Although some commenters conducted and 
submitted data from online surveys for the proposition that consumers 
are purchasing contact lenses as their prescriptions are about to 
expire, this data does not show the quantity of lenses that consumers 
are actually purchasing. For example, even if one were to assume that 
the APCO online survey results were completely reliable, the survey 
only asked consumers whether they purchased lenses at certain points in 
time; it did not assess the quantity of lenses that consumers actually 
purchased. The fact that a consumer purchased some contact lenses just 
prior to a prescription expiring does not necessarily mean that the 
consumer has purchased an excessive amount of contact lenses, nor does 
it support the contention that consumers are no longer getting eye 
examinations. Instead, consumers could be purchasing small amounts of 
lenses to last until their next scheduled eye examination. When the 
Commission examined the contact lens industry in 2005, it found that 
consumers do not typically purchase a full year's supply at one 
time.\307\ The Commission has not seen any evidence indicating that 
this has changed. Although commenters to the current Rule review 
provided various anecdotal and hypothetical accounts of consumers 
buying excessive quantities of lenses, they did not provide empirical 
evidence regarding the amount of lenses consumers are obtaining, nor 
did they submit evidence to show that consumers are not visiting their 
eye care practitioners as frequently.\308\ Second, regardless of the 
evidence, or lack thereof, in the record to support the quantity limit 
proposals, the Commission believes that it would be difficult to 
administer the proposed limits, and that rather than increasing patient 
eye health and safety, such proposals could have the opposite effect. 
For example, if a consumer is running out of contact lenses and does 
not have time to see a prescriber promptly, there is a significant 
chance that the consumer will not adhere to the recommended contact 
lens replacement schedule and will instead try to ``stretch out'' their 
lenses by re-wearing them until they can visit a prescriber. The 
failure to replace lenses is a well-documented cause of many contact-
lens-related health issues.\309\ Absent empirical evidence that a 
substantial number of consumers are obtaining excessive amounts of 
contact lenses, or are not returning to their prescribers for eye 
examinations, the Commission believes that the risk of not replacing 
lenses outweighs the harm of consumers obtaining more lenses than 
strictly anticipated by the length of a contact lens prescription.
---------------------------------------------------------------------------

    \307\ 2005 Contact Lens Report, supra note 14, at 6 note 18 
(citing two studies that found that just 12-20% of consumers 
purchase a year's supply at a time).
    \308\ Indeed, the Coalition for Patient Vision Care Safety 
indicated that ``87 percent of contact lens patients had an eye exam 
last year.'' Comment #621.
    \309\ Cope, supra note 29, at 867 (``contact lens wearers who do 
not follow recommended contact lens replacement schedules have more 
complications and eye discomfort'').
---------------------------------------------------------------------------

    Nevertheless, the Commission is concerned about anecdotal reports 
that sellers are contacting patients and encouraging them to stockpile 
contact lenses prior to the expiration of their prescriptions in order 
to avoid visiting their eye care professionals. The Commission cautions 
sellers that such practices run counter to the spirit of the Act, and 
the Commission will look closely at these alleged practices.
    The Commission also declines to propose that the Rule be amended to 
provide that a ``contact lens prescription shall be valid for an 
unlimited quantity of lenses regardless of any prescriber-imposed 
limitation to the contrary.'' \310\ The commenter suggesting this 
amendment produced no evidence supporting the allegation that 
prescribers are using quantity limits to undercut the length of a 
prescription.
---------------------------------------------------------------------------

    \310\ LD Vision Group (Comment #544).
---------------------------------------------------------------------------

    The Commission also notes that, as recognized during the initial 
rulemaking, some State laws or regulations may require prescribers to 
include quantity information on the prescription and some prescribers 
in other States without such requirements

[[Page 88550]]

may choose to include such information on the prescription. At this 
time, the Commission reiterates that such prescribers must not use 
quantity limits to frustrate the prescription expiration requirements 
of Section 315.6, and that the quantity specified in the prescription 
must be sufficient to last through the prescription's expiration 
date.\311\
---------------------------------------------------------------------------

    \311\ 69 FR at 40488. If the prescription specifies a lesser 
quantity of lenses or refills, the prescriber must have a legitimate 
medical reason for doing so, and the requirements imposed by Section 
315.6(b) on writing a prescription for less than one year must be 
met. Id.
---------------------------------------------------------------------------

    Finally, the Commission also believes that the Rule, as currently 
drafted, is sufficient to address the quantity limit concerns posited 
by commenters. During the initial rulemaking, the Commission examined 
the issue of requiring quantity limits on prescriptions.\312\ At that 
time, the Commission concluded that it was not necessary to include the 
quantity of lenses on the prescription to limit patients' ability to 
circumvent the expiration date because the verification process would 
allow prescribers to prevent patients from ordering excessive contact 
lenses.\313\ In this rule review, commenters raised concerns that the 
verification process was not an adequate safety net because the 
``verification process is not triggered when a patient provides a 
contact lens retailer with a complete copy of prescription'' and the 
verification process is bypassed.\314\ Accordingly, it is possible that 
consumers could use a copy of a prescription to shop at multiple 
retailers, or engage in other practices, in order to obtain excessive 
amounts of contact lenses.\315\ Although it is possible that these 
practices could occur, there is no empirical evidence in the record to 
show the frequency or extent of such practices.\316\
---------------------------------------------------------------------------

    \312\ In reaching that determination, the Commission first noted 
that the Act did not require the inclusion of quantity information 
on the prescription. The Commission then discussed its concern that 
if quantity information was included, prescribers might use those 
quantity limits to impose prescription expiration dates that are 
effectively shorter than the one-year period imposed under the Act. 
69 FR at 40488.
    \313\ 69 FR at 40488 (explaining that Section 315.5(b) requires 
verification requests to contain the quantity of lenses ordered, and 
that the quantity ordered may be a legitimate basis for a prescriber 
to treat a request for verification of a prescription as 
``inaccurate'').
    \314\ American Optometric Association (Comment #644). See also 
Coalition for Patient Vision Care Safety (Comment #621).
    \315\ Id.
    \316\ For the same reasons, the Commission also declines to 
propose to amend the Rule per the American Optometric Association's 
proposal that the Commission limit the quantity of contact lens 
boxes that retailers advertise as being able to be purchased at one 
time. Comment #644. In its comment, the American Optometric 
Association contended that it is possible that consumers could 
purchase large amounts of contact lenses from some online retailers; 
however, it did not provide support for this contention.
---------------------------------------------------------------------------

    Other commenters encouraged the Commission to increase enforcement 
efforts to prevent consumers from obtaining more contact lenses than 
anticipated by the length of the prescription.\317\ As already noted, 
if the Commission receives evidence that sellers are dispensing contact 
lenses in violation of the Rule, the Commission will investigate such 
allegations, as appropriate.
---------------------------------------------------------------------------

    \317\ See, e.g., Day (Comment #4); Mathai (Comment #33); Nelson 
(Comment #130); Hans (Comment #168); Garcia (Comment #511); Gandy 
(Comment #530); Tass (Comment #586).
---------------------------------------------------------------------------

B. Private Label Lenses and Contact Lens Substitution

1. Private Label Lenses
    A few sellers commented on the Rule provision regarding private 
label lenses.\318\ Section 315.2 of the Rule defines private label 
contact 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.'' \319\ A 
prescription for private label contact lenses, in addition to other 
required information, must include the name of the manufacturer, trade 
name of the private label brand, and if applicable, trade name of 
equivalent brand name.\320\ The Rule's requirements for private label 
lens prescriptions track the language of the Act.\321\ Although most 
contact lenses are sold under their national brand name, some 
manufacturers also distribute their lenses to prescribers and retailers 
under private labels. Sometimes the private label is unique to that 
seller and other times the private label brand may be available at 
multiple outlets.\322\
---------------------------------------------------------------------------

    \318\ LD Vision Group (Comment #544); 1-800 CONTACTS (Comment 
#568).
    \319\ 16 CFR 315.2.
    \320\ Id.
    \321\ See 15 U.S.C. 7610(3).
    \322\ 2005 Contact Lens Report, supra note 14, at 14-15.
---------------------------------------------------------------------------

    LD Vision Group, an online contact lens retailer, asserted that 
manufacturers and prescribers design anticompetitive strategies 
involving private label lenses to ``thwart consumer freedom.'' \323\ 
Specifically, the company contended that to keep consumers from 
purchasing contacts elsewhere, some prescribers ``will provide 
unpopular or private-label lenses without published equivalents or for 
which the equivalents are confusing.'' \324\ For instance, the company 
stated that one private label ``is purportedly available with an 8.3 or 
8.6 base curve, while the brand name lens--though it is the exact same 
lens--is purportedly available with an 8.4 or 8.7 base curve.'' \325\ 
Another manufacturer, according to LD Vision Group, ``offers four 
different lenses under a private label: Standard, plus, premium, and 
premium plus, but the national-label equivalents do not use the same 
identifiers.'' \326\ Although prescribers are required by the Rule to 
list equivalent information on the prescription, LD Vision Group 
asserted that prescribers do not always comply, and absent 
manufacturers' identification of equivalent lenses, ``the retailer must 
either refuse to dispense unknown equivalents or make assumptions based 
on intentionally misleading private-label designations and risk 
dispensing the wrong lenses to the potential detriment of their 
customers' eye health.'' \327\ LD Vision Group did not quantify the 
extent of this problem, or provide empirical evidence as to its 
scope.\328\
---------------------------------------------------------------------------

    \323\ Comment #544. LD Vision Group explained that manufacturers 
acquiesce to prescribers because it is the prescribers who select 
their patients' contact lenses. Id.; see also 1-800 CONTACTS 
(Comment #568) (commenting on manufacturers' strong incentives to 
cater to the interests of prescribers rather than consumers because 
prescribers determine the brand and modality of their patients' 
lenses).
    \324\ Comment #544.
    \325\ LD Vision Group did not identify the private label or 
manufacturer engaged in this practice. Comment #544.
    \326\ Id.
    \327\ As discussed in Section V.B.2, infra, when sellers 
substitute lenses that are not identical to the prescribed contact 
lenses, they violate the Rule.
    \328\ The Commission understands that sales of private label 
lenses comprise a small part of the market, and most major 
manufacturers do not sell private label lenses.
---------------------------------------------------------------------------

    In order to remedy the aforementioned issues, LD Vision Group 
proposed that the Commission amend the Rule to require prescribers to 
annotate a private label lens prescription with the brand-name 
equivalent and, if a name-brand equivalent is unavailable, the private 
label prescription must be medically necessary for that particular 
patient. It also recommended requiring manufacturers of contact lenses 
to disclose brand equivalency information on private label and brand-
label packaging, or otherwise make it available to sellers.\329\
---------------------------------------------------------------------------

    \329\ LD Vision Group (Comment #544).
---------------------------------------------------------------------------

    The Commission declines to propose to modify the Rule to implement 
these recommendations. Although the Act expressly requires that, in the 
case of private label contact lens prescriptions, prescribers include 
``trade name of equivalent brand name,'' the Act does

[[Page 88551]]

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.\330\ Nor does the Act expressly contemplate the imposition of 
disclosure requirements on manufacturers. However, nothing in the Act 
or Rule prohibits manufacturers from making brand equivalency 
disclosures on their packaging, or otherwise making such information 
available to sellers. The Commission understands that some, if not all, 
manufacturers who offer private labels already make this information 
readily available to retailers. Additionally, the Commission notes that 
it is a violation of the Rule for prescribers to fail to comply with 
their obligation to specify a brand equivalent, should one exist, when 
writing a prescription. The Commission encourages sellers and consumers 
to submit evidence of any such violations to the agency for possible 
enforcement action.
---------------------------------------------------------------------------

    \330\ In the initial rulemaking, sellers made a recommendation 
to open up the market by requiring prescribers, when prescribing 
private label contact lenses, to identify on the prescription the 
name of a brand that a consumer could purchase from a retailer other 
than the prescribing office. 69 FR at 40503. The Act does not limit, 
in any way, the brand that a prescriber must select and thus, the 
Commission concluded that such a requirement would go beyond the 
Act. Id. LD Vision Group's similar proposal to limit prescribers 
from prescribing private label brands without a brand-equivalent, 
except in the case of medical necessity, fails for the same reason.
---------------------------------------------------------------------------

2. Alteration of Contact Lens Prescriptions by Sellers
    Section 315.5(e) of the Rule prohibits sellers from altering a 
contact lens prescription.\331\ Notwithstanding this prohibition, 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.'' \332\ The language of 
this Rule provision is substantively the same as the language of the 
Act, with one exception discussed below.\333\
---------------------------------------------------------------------------

    \331\ 16 CFR 315.5(e).
    \332\ Id.
    \333\ See 15 U.S.C. 7603(f).
---------------------------------------------------------------------------

    The Commission received a number of comments, primarily from 
prescribers, that complained that online contact lens sellers are 
selling patients lenses different from those they prescribed.\334\ 
Prescribers expressed concern that contact lenses are being treated 
like commodities, rather than restricted medical devices regulated by 
the FDA.\335\ These commenters contended that contact lenses, even 
those with similar refractive specifications, are not 
interchangeable.\336\ One commenter, a manufacturer, opined that ``each 
brand is unique and proprietary to each manufacturer and designed to 
suit a different set of corresponding patient physiology and consumer 
needs.'' \337\
---------------------------------------------------------------------------

    \334\ See, e.g., Kapoor (Comment #58); Narayan (Comment #60); 
Thomas (Comment #61); Weinberg (Comment #87); Anderson (Comment 
#96); Hopkins (Comment #102); Johnson (Comment #109); O'Brien 
(Comment #127); Stewart (Comment #136); Hans (Comment #168); 
Hamilton (Comment #216); Gibson (Comment #217); Cassis (Comment 
#233); Chesen (Comment #321); Silver (Comment #349); McWilliams 
(Comment #362); Wittmann (Comment #421); Nett (Comment #449); Eggers 
(Comment #473); Kegarise (Comment #477); Kosunick (Comment #501); 
Wren (Comment #520); Lai (Comment #541); Hamada (Comment #603); 
Coalition for Patient Vision Care Safety (Comment #621); Maceyko 
(Comment #642); American Optometric Association (Comment #644).
    \335\ Kelly (Comment #78); Callihan (Comment #187); Sancho 
(Comment #226); West (Comment #230); Nett (Comment #449); Vu 
(Comment #561); Reed (Comment #579). Cf. LD Vision Group (Comment 
#544) (calling lenses a ``disposable commodity'').
    \336\ See, e.g., Johnson & Johnson Vision Care, Inc. (Comment 
#582) (citing studies supporting this statement). A number of 
commenters similarly explained that because each contact lens fits 
the eye differently, there is no such thing as a generic contact 
lens. See, e.g., Jones (Comment #63); Miyamura (Comment #77); Jones 
(Comment #83); Easton (Comment #432).
    \337\ Comment #582. Johnson & Johnson Vision Care, Inc. 
described several parameters that make a contact lens brand unique, 
including oxygen transmissibility, water content, iconicity, 
rigidity or modulus, silicone and fluorine content, lipid 
deposition, wettability/wetting agent, thickness, diameter, base 
curve, edge design, surface characteristics/treatments, modality, UV 
blocking, and interaction with care solutions. Other commenters 
mentioned modality (daily, two week replacement, or monthly), 
optical clarity, lifestyle, medical conditions, and current 
medications as factors influencing the prescriber's selection of the 
contact lens to prescribe. Morgan (Comment #144); Assell (Comment 
#397).
---------------------------------------------------------------------------

    Several prescribers and a manufacturer also explained that 
prescribers work with patients to fit them with the most compatible, 
safe, and effective contact lens and that each patient's eyes react 
differently to individual brands.\338\ According to these commenters, 
when a patient receives a contact lens that is not identical to the one 
prescribed, those lenses have not been fit on the patient, may not be 
appropriate, and can even be harmful for the patient.\339\ 
Specifically, prescribers stated that scarring, infection, allergic 
reactions, corneal ulcers, impaired or even lost vision can result or 
have resulted from patients wearing lenses that were not 
prescribed.\340\ A few prescribers described patients who, after 
wearing lenses that had not been prescribed for them, could no longer 
wear contact lenses or whose vision could no longer be fully 
corrected.\341\
---------------------------------------------------------------------------

    \338\ See Sasner (Comment #182); Williams (Comment #261); 
Steinleitner (Comment #517); Nielson (Comment #565) (prescriber 
questioning why he learned how to fit contact lenses if patients can 
get any lens they want without his input); Johnson & Johnson Vision 
Care, Inc. (Comment #582).
    \339\ Id.
    \340\ Williford (Comment #38); Kapoor (Comment #58); Jones 
(Comment #63); Morgan (Comment #144); Herve (Comment #148); Sausner 
(Comment #182); McWilliams (Comment #362); Elmore (Comment #396); 
Wittmann (Comment #421); Kegarise (Comment #447); Sirotkin (Comment 
#464); Abbott (Comment #497); Wren (Comment #520); Evans (Comment 
#523); Hamada (Comment #603); Capps (Comment #610); Coalition for 
Patient Vision Care Safety (Comment #621); Vehab (Comment #622); 
Mortenson (Comment #636); Maceyko (Comment #642).
    \341\ Schram (Comment #184); McWilliams (Comment #362).
---------------------------------------------------------------------------

    As to the source of the alteration problem, commenters pointed to 
both online sellers as well as patients. Commenters, almost exclusively 
prescribers, asserted that sellers want to maximize their profits and 
may have little to no consideration for their customers' eye 
health,\342\ and that patients switch brands to obtain cheaper lenses 
or seek brands they have seen in commercials.\343\ Some prescribers 
also stated or implied that these substitutions occur as a result of 
the passive verification system, and encouraged the Commission to adopt 
an active verification system.\344\
---------------------------------------------------------------------------

    \342\ Nguyen (Comment #82); Eggers (Comment #473); Lupinski 
(Comment #499); Nielsen (Comment #565). Other prescribers are 
concerned that they will be liable or at risk of losing their 
licenses if the substitution causes the consumer harm. See, e.g., 
Carroll (Comment #5); Thomas (Comment #61).
    \343\ LaDouceur (Comment #178); Schram (Comment #184); Marler 
(Comment #504); Vehab (Comment #622).
    \344\ Prescribers contend that after sellers convince patients 
to order different lenses than those prescribed, or patients give 
sellers the name of a lens not identical to the prescribed lens, the 
sellers send a verification request containing the non-prescribed 
lenses, and those requests are sometimes passively verified. Eggers 
(Comment #473); Wren (Comment #520). As previously explained, see 
supra Section IV.C.1, the Commission lacks authority to eliminate 
the passive verification system.
---------------------------------------------------------------------------

    It is unclear how frequently illegal substitutions are occurring, 
or how many sellers are engaged in this activity. In its comment, 
Johnson & Johnson Vision Care, Inc. cited to a 2015 online survey 
conducted on its behalf that found that ``one-in-four online consumers 
report having received a different brand of contact lenses than they 
had ordered without being given advanced warning they were getting 
another brand.'' \345\ Even assuming the survey methodology is sound 
and the stated conclusion of the survey is accurate, it is not clear 
whether the positive responses reflect instances

[[Page 88552]]

when sellers made illegal alterations or, alternatively, instances when 
consumers ordered a brand other than the prescribed brand and the 
prescribers then corrected the prescriptions. Nor is it clear whether 
positive responses include instances where eye care professionals 
prescribed private label lenses and sellers appropriately substituted 
them with identical lenses, made by the same manufacturer and sold 
under a different label, as expressly permitted by Section 315.5(e). 
Because one cannot tell the percentage that was the result of 
unauthorized alterations, the survey data is not conclusive.\346\
---------------------------------------------------------------------------

    \345\ Comment #582.
    \346\ Other seemingly relevant survey questions, one of which a 
commenter cited to, may be similarly flawed. For example, the 
Coalition for Patient Vision Care Safety pointed out that 31% of 
respondents answered positively when asked: ``When buying contact 
lenses online or over the phone in the past, has the company you 
were ordering from ever informed you that they do not carry or do 
not currently have stocked, the brand of contact lenses on your 
prescription, and advised you to get another brand of contact lenses 
instead?'' Comment #621. In response to a subsequent survey 
question, 80% of those respondents indicated that they ``then 
order[ed] that other brand of contact lenses.'' The Commission notes 
that positive responses to these questions do not necessarily 
reflect a violation of the Rule. For example, a prescriber changing 
a prescription to a different lens in the interim would thereby 
render the sale proper.
---------------------------------------------------------------------------

    The Commission notes that unauthorized alterations violate the Rule 
as currently written, and thus there is no need to amend the Rule to 
address this issue.\347\ In some cases, patients may request to 
purchase a brand of lenses not identical to the one prescribed. In 
those instances, the seller may include the wrong brand in the 
verification request. If any of the information required by Section 
315.5(b)(2) to be included in the verification request is incorrect, 
prescribers are encouraged to provide the correct information to the 
seller.
---------------------------------------------------------------------------

    \347\ Because prescription alteration violates the Rule, the 
Commission need not make its own assessment of Johnson & Johnson 
Vision Care, Inc.'s and numerous prescribers' statements concerning 
the non-interchangeability of lenses and the resulting eye health 
risks.
---------------------------------------------------------------------------

    Several commenters requested that the Commission better enforce the 
Rule against sellers that engage in illegal substitutions.\348\ If the 
Commission receives evidence that sellers are engaged in illegal 
substitutions, the Commission will investigate the allegations, as 
appropriate.\349\
---------------------------------------------------------------------------

    \348\ Thomas (Comment #61); Lai (Comment #541); Johnson & 
Johnson Vision Care, Inc. (Comment #582).
    \349\ The Commission notes that the prescriber has the ability 
to block an illegal substitution by actively responding to a 
verification request for a non-prescribed lens and indicating its 
invalidity. In fact, in circumstances where a consumer selects a 
non-prescribed brand, the prescriber is likely the only one who can 
``catch'' the error.
---------------------------------------------------------------------------

    Lastly, one commenter, an optometrist, recommended that a retailer 
should be required to warn or educate patients about the potential 
consequences of changing brands or other parameters without a doctor's 
authorization through a ``statement of education'' with every order, 
warning patients that ``contact lenses are a medical device and the 
wearing of or changing of a brand or prescription without a doctor's 
authorization is illegal and could result in damage, even blindness to 
the recipient.'' \350\ The Commission declines to modify the Rule in 
such a fashion. Although the Commission does not take issue with the 
importance of educating patients about the need to consult their 
prescriber before switching contact lens brands, and encourages 
sellers, prescribers, and manufacturers to do so, we have no evidence 
that the benefit of imposing such a requirement on sellers would 
outweigh the costs.
---------------------------------------------------------------------------

    \350\ Kegarise (Comment #447).
---------------------------------------------------------------------------

    Through discussions with industry members, it has come to the 
Commission's attention that in addition to prescribers, some other 
sellers 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. The language of the Act clearly permits 
substitution in cases where the same contact lenses are manufactured by 
the same company and sold under multiple labels to individual 
providers.\351\ Although the Rule similarly permits a seller to 
substitute lenses that are identical to, and are made by the same 
manufacturer as, the one listed on the prescription,\352\ the language 
set forth in Section 315.5(e) of the Rule could be read to limit such 
substitution to instances where private label lenses are listed on the 
prescription and the seller wishes to substitute brand name 
lenses.\353\
---------------------------------------------------------------------------

    \351\ 15 U.S.C. 7603(f).
    \352\ 16 CFR 315.5(e).
    \353\ Section 315.5(e) modifies ``contact lenses'' with the term 
``private label,'' but the Act does not contain that modifier. Cf. 
15 U.S.C. 7603(f).
---------------------------------------------------------------------------

    The Commission recognizes that the current construction of Section 
315.5(e) of the Rule does not conform to the language or intent of the 
Act. The clear language of the Act allows sellers to substitute private 
label lenses for brand name lenses when the substituted lenses are 
``manufactured by the same company and sold under multiple labels to 
individual providers.'' \354\ To conform the Rule to the Act, the 
Commission proposes to strike the words ``private label'' from Section 
315.5(e) and seeks comment on its proposal. The definitions in the Rule 
of a ``contact lens prescription'' and of a ``private label contact 
lens'' would remain unchanged.
---------------------------------------------------------------------------

    \354\ 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 as long as the lenses are identical.
---------------------------------------------------------------------------

C. HIPAA Issues

    The Commission received a few comments that identified concerns 
with how the Rule's verification framework interacts with the Health 
Insurance Portability and Accountability Act of 1996 \355\ (``HIPAA'') 
Privacy and Security Rules (``HIPAA Rules'').\356\ One prescriber 
expressed the opinion that the Contact Lens Rule's verification system 
was in direct conflict with HIPAA and detailed his attempts to procure 
HIPAA authorizations from his patients prior to releasing the 
prescription to a third-party seller.\357\ Another commenter 
recommended that HIPAA should apply to the verification process and 
that any verification request should be accompanied by an authorization 
signed by the patient.\358\ A third commenter expressed concern that 
automated telephonic verification requests were in direct violation of 
HIPAA because the patient's personal information was relayed to the 
person answering the telephone, without any mechanism to ensure that it 
was the intended recipient.\359\ A few prescribers also complained that 
sellers' practices of trying to obtain prescriptions without patient 
authorization violated HIPAA.\360\
---------------------------------------------------------------------------

    \355\ Public Law 104-191 (Aug. 21, 1996).
    \356\ 45 CFR parts 160, 164.
    \357\ Ciszek (Comment #134).
    \358\ Pao (Comment #181).
    \359\ Stuart (Comment #635) (consumers' ``personal and medical 
information is currently being transmitted unsecured to a third 
party by using an automated phone verification system'').
    \360\ St. Martin (Comment #292) (``their phishing for 
prescriptions should be considered a HIPAA violation because often 
this is done without the patient's permission''). See also Vensand 
(Comment #59) (expressing concern about the acquisition and sale of 
patient information); Ciszek (Comment #134) (complaining that 
sellers are calling of their own accord, without the patient 
initiating the request).
---------------------------------------------------------------------------

    Other commenters stated that some prescribers were not complying 
with the Contact Lens Rule and were using HIPAA to avoid doing so. One 
seller complained that ``[s]ome prescribers will still refuse to verify 
even with the law in place, stating (incorrectly) that HIPAA or a state 
privacy rule prohibits

[[Page 88553]]

release of the prescription and that only the patient can ask for it.'' 
\361\ Likewise, the National Association of Optometrists and Opticians 
noted that it was ``aware of instances where prescribers incorrectly 
inform patients that HIPAA or other laws require a written 
authorization from the patient or face-to-face requests by the patient 
to the prescriber.'' \362\ This commenter recommended that the 
Commission make clear to prescribers, sellers, and consumers that HIPAA 
does not prevent compliance with the Rule's verification process and 
that to claim otherwise is an unfair and deceptive practice.\363\
---------------------------------------------------------------------------

    \361\ LD Vision Group (Comment #544).
    \362\ Comment #549.
    \363\ Id.
---------------------------------------------------------------------------

    The Commission reiterates that the HIPAA Privacy Rule does not 
restrict prescribers' ability to provide or verify contact lens 
prescriptions under the Rule.\364\ As a preliminary matter, HIPAA does 
not require submission of a HIPAA authorization for the prescriber to 
release a contact lens prescription to a patient.\365\ Furthermore, as 
the Commission explained in the initial rulemaking, the HIPAA Privacy 
Rule permits a HIPAA covered entity, such as a covered prescriber, to 
disclose protected health information (``PHI'') without patient 
authorization for ``treatment'' purposes or when ``required by law,'' 
as well as for other specified purposes.\366\ Providing, confirming, or 
correcting a prescription for contact lenses for a contact lens seller 
as contemplated under the Contact Lens Rule constitutes ``treatment'' 
under the HIPAA Privacy Rule.\367\ In addition, to the extent the 
disclosure of PHI to provide, confirm, or verify a contact lens 
prescription is required under the Act and the Rule, such disclosure 
constitutes a disclosure ``required by law'' under the HIPAA Privacy 
Rule.\368\ For these reasons, patient authorization is not required for 
a prescriber to provide or verify a contact lens prescription with the 
contact lens seller, or to provide a contact lens prescription to the 
patient.\369\
---------------------------------------------------------------------------

    \364\ 69 FR at 40501.
    \365\ See 45 CFR 164.502(a)(1); U.S. Dep't of Health & Human 
Servs., Office for Civil Rights, ``Summary of the HIPAA Privacy 
Rule'' 4-5 (2003), http://www.hhs.gov/sites/default/files/privacysummary.pdf (``A covered entity is permitted . . . to use and 
disclose protected health information, without an individual's 
authorization, for the following purposes or situations: (1) To the 
Individual (unless required for access or accounting of 
disclosures); (2) Treatment, Payment, and Health Care Operations; 
(3) Opportunity to Agree or Object; (4) Incident to an otherwise 
permitted use and disclosure; (5) Public Interest and Benefit 
Activities; and (6) Limited Data Set for the purposes of research, 
public health or health care operations. Covered entities may rely 
on professional ethics and best judgments in deciding which of these 
permissive uses and disclosures to make.'') (footnote omitted).
    \366\ 69 FR at 40501.
    \367\ Id. See also Standards for Privacy of Individually 
Identifiable Health Information, 67 FR 53182, 53219 (Aug. 14, 2002). 
The U.S. Department of Health & Human Services has explained further 
that ``disclosure of protected health information by an eye doctor 
to a distributor of contact lenses for the purpose of confirming a 
contact lens prescription is a treatment disclosure and is permitted 
under the Privacy Rule at 45 CFR 164.506.'' See U.S. Dep't Health & 
Human Servs., Health Information Privacy, FAQs, ``Does the HIPAA 
Privacy Rule permit an eye doctor to confirm a contact prescription 
received by a mail order contact company?,'' http://www.hhs.gov/hipaa/for-professionals/faq/270/does-hipaa-permit-an-eye-doctor-to-confirm-a-contract-prescription-from-a-mail-order-company/index.html.
    \368\ See 45 CFR 164.512(a).
    \369\ In addition, the HIPAA Privacy Rule right of access 
requires a covered prescriber to provide to the patient upon request 
or to another person she designates a copy of a prescription. See 45 
CFR 164.524(c)(3). See also U.S. Dep't Health & Human Servs., Health 
Information Privacy, HIPAA Guidance, ``Individuals' Right under 
HIPAA to Access their Health Information,'' http://www.hhs.gov/hipaa/for-professionals/privacy/guidance/access/.
---------------------------------------------------------------------------

    In addition to the comments submitted in this rule review, the 
Commission has received other questions and complaints related to 
prescribers' HIPAA obligations under the Rule. For example, one 
prescriber asked whether HIPAA precluded his office from emailing a 
copy of a prescription to a patient without written authorization if 
the email communication was not encrypted. Correspondingly, some 
consumers have complained that their eye care practitioners have 
refused to email contact lens prescriptions to them.
    As a threshold matter, the Contact Lens Rule itself contemplates 
email communication, stating that the prescriber shall ``provide or 
verify'' the prescription ``by electronic or other means.'' \370\ 
Further, the HIPAA Rules do not preclude covered prescribers from 
emailing contact lens prescriptions to patients or sellers. According 
to guidance provided by the U.S. Department of Health & Human Services, 
the HIPAA Rules allow health care providers to communicate 
electronically with patients, provided they apply reasonable 
safeguards.\371\ Although a covered provider must consider encryption 
to protect against unintentional disclosures, the provider may 
determine that it is not reasonable and appropriate, and may instead 
apply precautions when transmitting unencrypted email, such as checking 
the email address for accuracy before sending, sending an email alert 
to the intended recipient for address confirmation prior to sending the 
message, and limiting the amount and type of PHI transmitted through 
the email.\372\
---------------------------------------------------------------------------

    \370\ 16 CFR 315.3(a)(2).
    \371\ U.S. Dep't Health & Human Servs., Health Information 
Privacy, FAQs, ``Does the HIPAA Privacy Rule permit health care 
providers to use email to discuss health issues and treatment with 
their patients?,'' http://www.hhs.gov/hipaa/for-professionals/faq/570/does-hipaa-permit-health-care-providers-to-use-email-to-discuss-health-issues-with-patients/. See also 45 CFR 164.530(c).
    \372\ Encryption of PHI must be implemented where a covered 
entity has determined that it is a reasonable and appropriate 
safeguard as part of its risk management. See U.S. Dep't Health & 
Human Servs., Health Information Privacy, FAQs, ``Is the use of 
encryption mandatory in the Security Rule?,'' http://www.hhs.gov/hipaa/for-professionals/faq/2001/is-the-use-of-encryption-mandatory-in-the-security-rule/index.html. A covered health care provider also 
must protect PHI in those emails while they are stored on servers, 
workstations, mobile devices, and other computer systems, through 
encryption and other safeguards, as appropriate. See 45 CFR 
164.306(a).
---------------------------------------------------------------------------

    Regardless, where an individual requests that the covered entity 
transmit PHI by unencrypted email, as is their right under the HIPAA 
Privacy Rule right of access, a covered entity must do so.\373\ Before 
sending unencrypted email containing PHI to a patient, the entity 
should advise the patient of the risk that the unencrypted PHI could be 
intercepted and accessed by unauthorized third parties. If, after 
having been advised of the risks the patient still prefers to receive 
his or her PHI via unencrypted email, the patient has the right to 
receive the PHI in that manner and the covered entity is not 
responsible for unauthorized access to the PHI during electronic 
transmission, nor is the covered entity responsible for safeguarding 
the PHI once delivered to the patient.\374\ Conversely, a covered 
prescriber also must honor a patient's reasonable request that the 
prescriber not send communications via unencrypted email, by offering 
other means, such as encrypted email, secure patient portal, postal 
mail, or telephone.\375\
---------------------------------------------------------------------------

    \373\ 45 CFR 164.524(c). See also U.S. Dep't Health & Human 
Servs., Health Information Privacy, FAQs, ``Individuals' Right under 
HIPAA to Access their Health Information 45 CFR 164.524,'' http://www.hhs.gov/hipaa/for-professionals/privacy/guidance/access/.
    \374\ 78 FR 5634 (Jan. 25, 2013).
    \375\ 45 CFR 164.522(b).
---------------------------------------------------------------------------

D. Enforcement Efforts

    In addition to proposing amendments to specific Rule provisions to 
further the Rule's goals of competition and patient welfare, several 
commenters also urged the Commission to increase its enforcement 
efforts and stressed the importance of enforcing the Rule to ensure 
that its benefits are realized and

[[Page 88554]]

its risks minimized.\376\ For example, several optometric associations 
urged the Commission to enforce the basic patient safeguards outlined 
in the Act to protect patients and reduce unnecessary costs.\377\ These 
commenters argued that the sale of contact lenses without a valid 
prescription increases risks for patients and ultimately leads to 
higher health costs, and called for the Commission to take action 
against retailers selling lenses without a valid prescription.\378\ The 
Coalition for Patient Vision Care Safety asserted that ``noncompliance 
with and loopholes within the law have resulted in a deceptive flow of 
information to contact lens patients, and have the potential to 
compromise seriously the vision health of patients.'' \379\ Many 
individual prescribers also urged the Commission generally to increase 
enforcement of the Rule.\380\
---------------------------------------------------------------------------

    \376\ See, e.g., Barr (Comment #639).
    \377\ American Optometric Association (Comment #644); Virginia 
Optometric Association (Comment #16); Wisconsin Optometric 
Association (Comment #30); Utah Optometric Association (Comment 
#39); Pennsylvania Optometric Association (Comment #46); Alabama 
Optometric Association (Comment #48); Iowa Optometric Association 
(Comment #79); Michigan Optometric Association (Comment #86); 
California Optometric Association (Comment #119); New Mexico 
Optometric Association (Comment #211); Mississippi Optometric 
Association (Comment #548); Ohio Optometric Association (Comment 
#556); Connecticut Association of Optometrists (Comment #560); North 
Carolina State Optometric Society (Comment #567); Tennessee 
Association of Optometric Physicians (Comment #575); Colorado 
Optometric Association (Comment #584); New Jersey Society of 
Optometric Physicians (Comment #595). See also American Academy of 
Ophthalmology (Comment #611) (``Wearing improper lenses can further 
complicate existing vision issues, including leading to infection in 
the eye. The sale of lenses without a prescription is a practice 
that continues despite the Rule, and the Academy believes that the 
Commission should take swift action to improve enforcement of the 
Rule.'').
    \378\ Id.
    \379\ Comment #621.
    \380\ See, e.g., Filandro (Comment #129); Sandler (Comment 
#135); Jankowski (Comment #153); Hans (Comment #168); Nguyen 
(Comment #175); Robertson (Comment #180); Schumacher (Comment #193); 
Sisson (Comment #254); Frederick (Comment #269); Bolenbaker (Comment 
#357); Yamamoto (Comment #408); Palmer (Comment #484); Williams 
(Comment #494); Marler (Comment #504); Koop (Comment #506); Korth 
(Comment #516); Lai (Comment #541); Piersol (Comment #571). See also 
Senator Perdue (Comment #569).
---------------------------------------------------------------------------

    On the other hand, online retailers such as 1-800 CONTACTS and 
Warby Parker recommended increased enforcement efforts against non-
compliant prescribers, particularly with respect to the automatic 
release of prescriptions.\381\ These commenters complained that despite 
``the widespread refusal of prescribers to release prescriptions,'' 
Commission action against prescribers has been limited to a handful of 
warning letters.\382\ These commenters proposed that the Commission 
amend Section 315.9 of the Rule, the enforcement provision, to add 
language to clarify that any violation of the Rule--by either sellers 
or prescribers--constitutes a violation of a rule under Section 18 of 
the Federal Trade Commission Act, subject to the same fines and 
penalties as any other violation of the Act.\383\
---------------------------------------------------------------------------

    \381\ 1-800 CONTACTS (Comment #568); Warby Parker (Comment 
#593).
    \382\ Id.
    \383\ 5 U.S.C. 57a.
---------------------------------------------------------------------------

    With respect to commenters' recommendations that the Commission 
increase its enforcement efforts, the Commission notes that the rule 
review process has been instrumental in identifying areas that need 
further investigation. Accordingly, the Commission will consider ways 
to leverage its enforcement, consumer education,\384\ and business 
guidance efforts to address the concerns identified.\385\ However, the 
Commission does not believe it necessary to amend Section 315.9 of the 
Rule to clarify that violations by either sellers or prescribers 
constitute a violation of the Rule under Section 18 of the Federal 
Trade Commission Act. The language of the Act and Rule are clear on 
this point.\386\
---------------------------------------------------------------------------

    \384\ The state optometric associations also encouraged the 
Commission to do more to ``ensure that patients are aware that 
contact lenses are regulated medical devices, whose safe use and 
optimal performance depends on eye examinations and professional 
supervision.'' Virginia Optometric Association (Comment #16); 
Wisconsin Optometric Association (Comment #30); Utah Optometric 
Association (Comment #39); Pennsylvania Optometric Association 
(Comment #46); Alabama Optometric Association (Comment #48); Iowa 
Optometric Association (Comment #79); Michigan Optometric 
Association (Comment #86); California Optometric Association 
(Comment #119); New Mexico Optometric Association (Comment #211); 
Mississippi Optometric Association (Comment #548); Ohio Optometric 
Association (Comment #556); Connecticut Association of Optometrists 
(Comment #560); North Carolina State Optometric Society (Comment 
#567); Tennessee Association of Optometric Physicians (Comment 
#575); Colorado Optometric Association (Comment #584); New Jersey 
Society of Optometric Physicians (Comment #595).
    \385\ Furthermore, the Commission believes that the proposed 
Rule amendment requiring a signed acknowledgment of receipt of a 
contact lens prescription will also aid Rule enforcement efforts. 
See supra Section III.A.3.
    \386\ See 15 U.S.C. 7608; 16 CFR 315.9.
---------------------------------------------------------------------------

E. Recommendations Regarding the Commission's Complaint Reporting 
System

    The Commission received a variety of comments suggesting proposals 
to improve perceived shortcomings in the agency's complaint reporting 
system to aid Rule enforcement efforts. Several optometric 
associations, for example, expressed their opinion that the 
Commission's consumer reporting process is not adequately designed to 
deal with contact lens complaints, and recommended that the Commission 
``develop a distinct complaint submission process for contact lens-
related concerns.'' \387\ More specifically, the American Optometric 
Association asserted that the online complaint assistant service is not 
appropriately set up to receive these types of complaints, and doctors 
who report issues of concern often feel their reports go 
unnoticed.\388\ This commenter stated that setting up a distinct 
Contact Lens Rule complaint system would benefit patients as well, 
providing them with a simple process to follow in case they have 
contact lens sale-related concerns.\389\ Likewise, the Coalition for 
Patient Vision Care Safety was troubled that the agency ``routes eye 
contact complaints about non-compliance to its general complaint 
lines'' and asserted that the general routing of complaints discourages 
the reporting of complaints and fails to provide the Commission with 
adequate and accessible information to enforce the Rule.\390\ The 
Coalition recommended that the Commission instead utilize dedicated 
personnel paired with a dedicated Web site or phone number within the 
Commission.\391\
---------------------------------------------------------------------------

    \387\ American Optometric Association (Comment #644); Virginia 
Optometric Association (Comment #16); Wisconsin Optometric 
Association (Comment #30); Utah Optometric Association (Comment 
#39); Pennsylvania Optometric Association (Comment #46); Alabama 
Optometric Association (Comment #48); Iowa Optometric Association 
(Comment #79); Michigan Optometric Association (Comment #86); 
California Optometric Association (Comment #119); New Mexico 
Optometric Association (Comment #211); Mississippi Optometric 
Association (Comment #548); Ohio Optometric Association (Comment 
#556); Connecticut Association of Optometrists (Comment #560); North 
Carolina State Optometric Society (Comment #567); Tennessee 
Association of Optometric Physicians (Comment #575); Colorado 
Optometric Association (Comment #584); New Jersey Society of 
Optometric Physicians (Comment #595).
    \388\ Comment #644.
    \389\ Id.
    \390\ Comment #621.
    \391\ Id.
---------------------------------------------------------------------------

    Other commenters expressed doubts that the complaint reporting 
system was adequate to capture specific types of complaints. For 
example, two State representatives, Rhode Island State Rep. Brian 
Patrick Kennedy and Arizona State Rep. Heather Carter, asserted that 
the current system favors eye care providers and their ability to file 
complaints against resellers of contact lenses.\392\ These commenters 
recommended that the Commission consider simplifying the complaint 
process to make it easier for consumers

[[Page 88555]]

to file complaints against their eye care provider, as well as 
replacement contact lens resellers. Likewise, some online retailers 
recommended that to facilitate enforcement efforts the Commission 
should ``create a user-friendly online complaint process for 
consumers.'' \393\ These commenters argued that the online complaint 
assistant is difficult to navigate and does not ask the appropriate 
questions to identify a Rule violation.\394\
---------------------------------------------------------------------------

    \392\ Comments ##536, 545.
    \393\ 1-800 CONTACTS (Comment #568); Warby Parker (Comment 
#593). See also LD Vision Group (Comment #544) (recommending that 
the Commission ``[c]reate an online reporting mechanism for sellers 
and consumers to report unfair prescriber practices'').
    \394\ 1-800 CONTACTS (Comment #568); Warby Parker (Comment 
#593).
---------------------------------------------------------------------------

    After careful consideration of these comments, the Commission 
declines to redesign its complaint reporting mechanism. The Commission 
has designed the FTC Complaint Assistant, the agency's online complaint 
reporting system, to be responsive to consumers who wish to file 
complaints about more than a hundred different types of products or 
services, while at the same time facilitating the filing of complaints 
regarding the most common complaint areas. Accordingly, the home page 
of the complaint system contains primary links for the FTC's seven most 
common complaint areas. The Commission's goal is that the primary links 
on the home page be responsive to at least 80 percent of the consumer 
complaints the agency receives. Although highlighting the most frequent 
types of complaints necessarily means that many areas of concern cannot 
be listed as separate categories, users can easily submit their 
complaint under the category ``Other'' when there is no listed category 
for the complaint, as is the case with contact lenses. Once the 
``Other'' category is selected, the subsequent Web page includes the 
``Health and Fitness'' subcategory, which is described as including, 
``prescriptions, eye care.'' After screening out complaints related to 
telemarketing phone calls and spam email, the first option on the 
following Web page asks whether the complaint relates to ``Eyeglasses 
or Contact Lenses.'' During this process, the person lodging the 
complaint is given ample room to describe the details of the complaint.
    Instructions on the FTC Complaint Assistant page explain that the 
FTC will categorize a complaint even if it does not fit one of the 
listed categories. In addition, the Web page also informs users that if 
they are ``having trouble categorizing [their] complaint,'' they can 
chat online with FTC tech support. Accordingly, the Commission believes 
that the FTC Complaint Assistant is configured to capture and report 
all contact lens-related complaints, whether they originate from 
consumers, prescribers, sellers, or others. However, resources 
permitting, the Commission will explore whether a dedicated email 
address would also be beneficial to complement the Complaint Assistant.

VI. Request for Comment

    You can file a comment online or on paper. For the Commission to 
consider your comment, we must receive it on or before January 30, 
2017. Write ``Contact Lens Rule, 16 CFR part 315, Project No. R511995'' 
on the comment. Your comment, including your name and your state, will 
be placed on the public record of this proceeding, including, to the 
extent practicable, on the public Commission Web site, at http://www.ftc.gov/os/publiccomments.shtm. As a matter of discretion, the 
Commission tries to remove individuals' home contact information from 
comments before placing them on the Commission Web site. Because your 
comment will be made public, you are solely responsible for making sure 
that your comment does not include any sensitive personal information, 
such as a Social Security number, date of birth, driver's license 
number or other state identification number or foreign country 
equivalent, passport number, financial account number, or credit or 
debit card number. You are also solely responsible for making sure that 
your comment does not include any sensitive health information, such as 
medical records or other individually identifiable health information. 
In addition, do not include any ``[t]rade secret or any commercial or 
financial information which is . . . privileged or confidential,'' as 
discussed in Section 6(f) of the FTC Act, 15 U.S.C. 46(f), and FTC Rule 
4.10(a)(2), 16 CFR 4.10(a)(2). In particular, do not include 
competitively sensitive information such as costs, sales statistics, 
inventories, formulas, patterns, devices, manufacturing processes, or 
customer names.
    If you want the Commission to give your comment confidential 
treatment, you must file it in paper form, with a request for 
confidential treatment, and you must follow the procedure explained in 
FTC Rule 4.9(c), 16 CFR 4.9(c). In particular, the written request for 
confidential treatment that accompanies the comment must include the 
factual and legal basis for the request, and must identify the specific 
portions of the comments to be withheld from the public record. Your 
comment will be kept confidential only if the FTC General Counsel 
grants your request in accordance with the law and the public interest.
    Postal mail addressed to the Commission is subject to delay due to 
heightened security screening. As a result, we encourage you to submit 
your comment online. To make sure that the Commission considers your 
online comment, you must file it at https://ftcpublic.commentworks.com/ftc/contactlensrule by following the instructions on the web-based 
form. If this Notice appears at http://www.regulations.gov/#!home. you 
also may file a comment through that Web site.
    If you file your comment on paper, write ``Contact Lens Rule, 16 
CFR Part 315, Project No. R511995'' on your comment and on the 
envelope, and mail your comment to the following address: Federal Trade 
Commission, Office of the Secretary, 600 Pennsylvania Avenue NW., Suite 
CC-5610 (Annex C), Washington, DC 20580, or deliver your comment to the 
following address: Federal Trade Commission, Office of the Secretary, 
Constitution Center, 400 7th Street SW., 5th Floor, Suite 5610 (Annex 
C), Washington, DC 20024.
    Visit the Commission Web site at http://www.ftc.gov to read this 
Notice and the news release describing it. The FTC Act and other laws 
that the Commission administers permit the collection of public 
comments to consider and use in this proceeding as appropriate. The 
Commission will consider all timely and responsive public comments that 
it receives on or before January 30, 2017. For information on the 
Commission's privacy policy, including routine uses permitted by the 
Privacy Act, see http://www.ftc.gov/ftc/privacy.htm.
    The Commission invites members of the public to comment on any 
issues or concerns they believe are relevant or appropriate to the 
Commission's consideration of proposed amendments to the Rule. The 
Commission requests you provide factual data, and in particular, 
empirical data, upon which your comments are based. In addition to the 
issues raised above, the Commission solicits public comment on the 
costs and benefits to industry members and consumers of each of the 
proposals as well as the specific questions identified below. These 
questions are designed to assist the public and should not be construed 
as a limitation on the issues on which public comment may be submitted.
Questions
    A. General Questions on Proposed Amendments: To maximize the 
benefits

[[Page 88556]]

and minimize the costs for prescribers and sellers (including small 
businesses), the Commission seeks views and data on the following 
general questions for each of the proposed changes described in this 
NPRM:
    1. What benefits would a proposed change confer and on whom? The 
Commission in particular seeks information on any benefits a change 
would confer on consumers of contact lenses.
    2. What costs or burdens would a proposed change impose and on 
whom? The Commission in particular seeks information on any burdens a 
change would impose on small businesses.
    3. What regulatory alternatives to the proposed changes are 
available that would reduce the burdens of the proposed changes while 
providing the same benefits?
    4. What additional information, tools, or guidance might the 
Commission provide to assist industry in meeting extant or proposed 
requirements efficiently?
    5. What evidence supports your answers?
    B. Acknowledgment of prescription release:
    1. Would the proposed amendment to require prescribers, after the 
completion of a contact lens fitting, to request the contact lens 
patient acknowledge receipt of the contact lens prescription by signing 
an acknowledgment form increase, decrease, or have no effect on 
compliance with the Rule's requirement that patients receive a copy of 
their contact lens prescription after the completion of the contact 
lens fitting? Why?
    2. Would the proposed amendment to require prescribers to maintain 
copies of the signed acknowledgments for a period of not less than 
three years increase, decrease, or have no effect on the Commission's 
ability to measure and enforce the Rule's automatic prescription 
release provision? Why?
    3. Would the proposed amendment to require the acknowledgment form 
to inform patients that they may purchase contact lenses from the 
seller of their choice increase, decrease, or have no effect on the 
extent to which patients understand their rights under the Rule? Why?
    4. Should the Commission consider other language to be included in 
the signed acknowledgment form? If so, what?
    5. Would allowing the acknowledgment form to be in either paper or 
electronic format increase, decrease, or have no effect on the extent 
to which patients understand their rights under the Rule? What other 
factors should the Commission consider to lower the cost and improve 
the reliability of executing, storing, and retrieving the signed 
acknowledgment forms?
    6. Should the proposed amendment contain specific language about 
the use of electronic acknowledgment forms and electronic signatures? 
If so, what? Should the proposed amendment contain particular 
requirements about the type of electronic acknowledgment forms and 
electronic signatures to be used? If so, what types should be required?
    7. Are there alternate ways to structure a patient acknowledgment 
requirement that would reduce the burdens of the proposed amendment 
while providing the same, or greater, benefits?
    8. What evidence supports your answers?
    C. Additional mechanisms for improving prescription portability:
    1. The Commission believes that the use of patient portals to 
provide patients with access to electronic copies of their 
prescriptions would benefit prescribers, sellers, and patients. The 
Commission seeks comment on the benefits or burdens that the use of 
patient portals would confer.
    2. The Commission seeks comment on the level of adoption of patient 
portals. Do prescribers use patient portals? Do patients use them? What 
are the rates of patient adoption when prescribers make them available?
    3. What characteristics should patient portals have in order to 
best promote prescription portability?
    4. Do patient portals have the potential to allow prescribers to 
comply with the automatic prescription release requirements of the 
Rule? If so, how? Do patient portals have limitations that would 
prevent them from being used by prescribers to comply with the 
automatic prescription release requirements of the Rule? If so, what 
are they?
    5. If the Commission were to determine that patient portals could 
be used to comply with the automatic prescription release requirements 
of the Rule, how would this determination affect the requirement that 
prescribers obtain a signed acknowledgment form from patients? Do 
patient portals have characteristics that could serve as a substitute 
for the signed acknowledgment form?
    6. What other technologies are available that could be implemented 
to improve prescription portability and thereby increase benefits and 
decrease burdens related to prescription release?
    7. What evidence supports your answers?
    D. Additional copies of prescriptions:
    1. In this NPRM, the Commission has preliminarily determined that 
requiring prescribers to provide additional copies of contact lens 
prescriptions to a patient upon request is required by the Act. How 
does this determination affect, if at all, the portability of contact 
lens prescriptions?
    2. Does this determination affect the accuracy of contact lens 
prescriptions presented to sellers? If so, how?
    3. Does this determination affect the administrative burden of 
prescribers? If so, how? Would any burden caused by this determination 
be offset by a reduced burden related to prescription verification 
requests? If so, how?
    4. What evidence supports your answers?
    E. Sellers designated to act on behalf of patients:
    1. Should the Commission impose a timeframe for prescribers, under 
Section 315.3(a)(2) of the Rule, to respond to requests from authorized 
third parties for a copy of a patient's prescription?
    2. If so, what would be the appropriate amount of time for a 
prescriber to be required to respond to a request from an authorized 
third party for a copy of a patient's prescription?
    3. What evidence supports your answers?
    F. Presentation of prescription ``directly or by facsimile'' under 
Section 315.5(a)(1):
    1. The Commission has initially determined that presenting a 
prescription to a seller ``directly or by facsimile'' includes the use 
of online patient portals. Does this determination further the Act's 
goal of prescription portability? If so, how?
    2. What is the impact, including costs and benefits, of this 
determination?
    3. What evidence supports your answers?
    G. Automated telephone systems as ``direct communication'' under 
Section 315.5(a)(2):
    1. What modifications to automated telephone calls, short of 
prohibiting the use of such calls, should the Commission consider to 
address the concerns raised by prescribers about the burden of such 
calls?
    H. Section 315.5(e)--No alteration of prescription provision:
    1. To conform the language of the Rule to the language of the Act, 
the Commission proposes to amend Section 315.5(e) to strike the words 
``private label.'' Would this proposed amendment alter the way that 
prescribers, sellers, or manufacturers do business, and if so, how?

[[Page 88557]]

    2. Are there alternative proposals that the Commission should 
consider?
    3. What evidence supports your answers?

VII. Communications by Outside Parties to the Commissioners or Their 
Advisors

    Written communications and summaries or transcripts of oral 
communications respecting the merits of this proceeding, from any 
outside party to any Commissioner or Commissioner's advisor, will be 
placed on the public record. See 16 CFR 1.26(b)(5).

VIII. Paperwork Reduction Act

    The existing Rule contains recordkeeping and disclosure 
requirements that constitute ``information collection requirements'' 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. OMB has approved the Rule's existing 
information collection requirements. (OMB Control No. 3084-0127).
    The proposed modifications to the Rule would require that 
prescribers obtain from patients, and maintain for a period of not less 
than three years, a signed acknowledgment form, entitled ``Patient 
Receipt of Contact Lens Prescription,'' confirming that patients 
received their contact lens prescriptions at the completion of their 
contact lens fitting. The proposed recordkeeping requirement would 
constitute an information collection as defined by 5 CFR 1320.3(c). 
Accordingly, the Commission is providing PRA burden estimates for them, 
as set forth below. The Commission will also submit this notice of 
proposed rulemaking and associated Supporting Statement to OMB for 
review under the PRA. The proposed requirement that prescribers provide 
an acknowledgment form to patients, however, does not constitute an 
information collection under the PRA, in that the Rule specifies the 
language that the form must contain.\395\
---------------------------------------------------------------------------

    \395\ The public disclosure of information originally supplied 
by the Federal government to the recipient for the purpose of 
disclosure to the public is not a ``collection of information.'' 5 
CFR 1320.3(c)(2).
---------------------------------------------------------------------------

A. Estimated Additional Hours Burden

    Commission staff estimates the paperwork burden of the proposed 
modifications based on its knowledge of the eye care industry. The 
staff believes there will be an additional burden on individual 
prescribers' offices to maintain the signed acknowledgment forms for a 
period of not less than three years.
    The number of contact lens wearers in the United States is 
currently estimated to be approximately 41 million.\396\ Therefore, 
assuming an annual contact lens exam for each contact lens wearer, 
approximately 41 million people would read and sign an acknowledgment 
form every year.\397\
---------------------------------------------------------------------------

    \396\ Cope, supra note 29, at 866.
    \397\ In the past, some commenters have suggested that typical 
contact lens wearers obtain annual exams every 18 months or so, 
rather than one every year. However, because most prescriptions are 
valid for a minimum of one year under the Rule, and use of a longer 
exam cycle would lead to an estimate of a lower number of signed 
acknowledgment forms and a reduced burden, we continue to estimate 
that patients seek exams every 12 months.
---------------------------------------------------------------------------

    Maintaining the form for a period of not less than three years does 
not impose a substantial new burden on individual prescribers and their 
office staff. The majority of states already require that optometrists 
maintain records of eye examinations for at least three years,\398\ and 
maintaining a one-page acknowledgment form per patient per year should 
not take more than a few seconds of time, and an inconsequential, or de 
minimis, amount of record space. Some prescribers might present the 
acknowledgment form electronically, and such format would allow the 
signed acknowledgment to be preserved without any additional burden. 
For other prescribers, the new recordkeeping requirement would likely 
require that office staff either preserve the signed acknowledgment 
form in paper format or electronically scan the signed acknowledgment 
form and save it as an electronic document. In the latter scenario, the 
Commission estimates this scanning and saving would take approximately 
one minute. The Commission does not possess any information regarding 
the percentage of prescribers' offices that use paper forms, electronic 
forms, or that scan paper files and maintain them electronically. 
Therefore, for purposes of this notice, staff will assume that all 
prescriber offices require a full one minute per form per year for 
record maintenance purposes arising from the proposed modifications.
---------------------------------------------------------------------------

    \398\ 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 above, the number of contact lens wearers in the United 
States is currently estimated to be approximately 41 million. 
Therefore, assuming one signed acknowledgment form for each contact 
lens wearer per year, prescribers' offices, collectively, would have to 
spend approximately 41 million minutes, or 683,333 hours, per year 
maintaining records of eye examinations (recordkeeping requirement).
    In all likelihood, the actual overall increased burden on 
prescribers may be less than 683,333 hours, because increasing the 
number of patients in possession of their prescriptions should 
correspondingly increase the number of consumers who provide their 
prescriptions to third-party sellers when purchasing contact lenses. 
This, in turn, should reduce the number of verification requests that 
third-party sellers would otherwise make to prescribers. Based on 
current estimates, responding to verification requests requires that 
prescribers spend approximately five minutes per request.\399\ The 
Commission, however, does not presently have enough information to 
devise a reliable estimate for how many more consumers are likely to 
present third-party sellers with a complete copy of their prescription 
following the proposed Rule modification. Therefore, for purposes of 
calculating the burden, the Commission, at this time, will not credit 
the expected reduction in verification burden.
---------------------------------------------------------------------------

    \399\ See American Optometric Association, Comment in response 
to the Agency Information Collection Activities; Proposed 
Collection; Comment Request, 81 FR 31938 (May 20, 2016), https://www.ftc.gov/policy/public-comments/initiative-665.
---------------------------------------------------------------------------

B. Estimated Total Labor Cost Burden

    Commission staff derives labor costs by applying appropriate hourly 
cost figures to the burden hours described above. The Commission 
assumes that office clerks will perform most of the labor when it comes 
to printing, disseminating, and storing the acknowledgment forms for 
prescribers' offices. According to Bureau of Labor Statistics, general 
office clerks earn an average wage of $15.33 per hour.\400\ Based on 
this data, the estimated total additional labor cost attributable to 
the proposed modifications to the Rule would amount to approximately 
$10,475,495.
---------------------------------------------------------------------------

    \400\ Press Release, U.S. Dep't of Labor, Bureau of Labor 
Statistics, ``Occupational Employment Statistics--May 2015,'' http://www.bls.gov/news.release/ocwage.t01.htm.
---------------------------------------------------------------------------

    While not insubstantial, this amount constitutes just under one-
fourth of one percent of the estimated overall retail market for 
contact lens sales in the

[[Page 88558]]

United States.\401\ Furthermore, the burden is likely to be less, 
because many prescribers' offices will not require a full minute to 
store the acknowledgment form. And, as noted above, increasing the 
number of patients in possession of their prescriptions should 
correspondingly increase the number of consumers who provide their 
prescriptions to third-party sellers when purchasing contact lenses. 
This, in turn, could potentially reduce the number of verification 
requests made to prescribers, and the time prescribers spend 
responding.
---------------------------------------------------------------------------

    \401\ According to The Vision Council, the contact lens sales 
market in the United States in 2015 totaled $4,664,200,000 at the 
retail level. See The Vision Council, ``U.S. Optical Industry Report 
Card,'' Dec. 2015. The estimated additional burden of $10,475,495 
thus amounts to approximately 0.22% of the total market.
---------------------------------------------------------------------------

    The Commission invites comments on: (1) Whether the proposed 
collection of information is necessary for the proper performance of 
the functions of the agency, including whether the information shall 
have practical utility; (2) the accuracy of the FTC's burden estimates, 
including whether the methodology and assumptions used are valid; (3) 
ways to enhance the quality, utility, and clarity of the information to 
be collected; and (4) ways to minimize the burden of collecting 
information.
    Comments on the information collection requirements subject to 
review under the PRA should also be submitted to Office of Management 
and Budget. If sent by U.S. mail, address comments to: Office of 
Information and Regulatory Affairs, Office of Management and Budget, 
Attention: Desk Officer for the Federal Trade Commission, New Executive 
Office Building, Docket Library, Room 10102, 725 17th Street NW., 
Washington, DC 20503. Comments sent to OMB by U.S. postal mail, 
however, are subject to delays due to heightened security precautions. 
Thus, comments instead should be sent by facsimile to (202) 395-5167.

IX. Regulatory Flexibility Act

    The Regulatory Flexibility Act (``RFA'') \402\ requires the 
Commission to conduct an analysis of the anticipated economic impact of 
the proposed amendments on small entities.\403\ The purpose of a 
regulatory flexibility analysis is to ensure the agency considers the 
impacts on small entities and examines regulatory alternatives that 
could achieve the regulatory purpose while minimizing burdens on small 
entities. Section 605 of the RFA \404\ provides that such an analysis 
is not required if the agency head certifies that the regulatory action 
will not have a significant economic impact on a substantial number of 
small entities.
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    \402\ 5 U.S.C. 601-612.
    \403\ The Commission also conducted an RFA analysis of prior 
amendments to the Rule implementing the Fairness to Contact Lens 
Consumers Act. 69 FR 40482, 40507 (July 2, 2004).
    \404\ 5 U.S.C. 605.
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    The Commission does not anticipate that the proposed amendments 
will have a significant economic impact on small entities, although 
they may affect a substantial number of small businesses. The proposed 
amendments require that prescribers obtain from patients, and maintain 
for a period of not less than three years, a signed acknowledgment 
form, entitled ``Patient Receipt of Contact Lens Prescription,'' 
confirming that patients received their contact lens prescriptions at 
the completion of their contact lens fitting. The Commission believes 
the burden of complying with this requirement likely will be relatively 
small. As discussed in the Paperwork Reduction Act section, the 
majority of states already require that optometrists maintain records 
of eye examinations for at least three years. The proposed amendment 
would require one additional page to be maintained as a record, which 
is likely a minimal burden. Therefore, based on available information, 
the Commission certifies that amending the Rule as proposed will not 
have a significant economic impact on a substantial number of small 
businesses.
    Although the Commission certifies under the RFA that the proposed 
amendment will not, if promulgated, have a significant impact on a 
substantial number of small entities, the Commission has nonetheless 
determined it is appropriate to publish an Initial Regulatory 
Flexibility Analysis to inquire into the impact of the proposed 
amendment on small entities. Therefore, the Commission has prepared the 
following analysis:

A. Description of the Reasons the Agency Is Taking Action

    In response to public comments, the Commission proposes amending 
the Rule to ensure that patients are receiving a copy of their contact 
lens prescription at the completion of a contact lens fitting.

B. Statement of the Objectives of, and Legal Basis for, the Proposed 
Amendments

    The objective of the proposed amendment is to clarify and update 
the Rule in accordance with marketplace practices. The legal basis for 
the Rule is the Fairness to Contact Lens Consumers Act.\405\ The Act 
authorizes the Commission to implement its requirements through the 
issuance of rules.
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    \405\ 15 U.S.C. 7601-7610.
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C. Small Entities to Which the Proposed Amendments Will Apply

    The proposed amendments apply to prescribers of contact lenses. The 
Commission believes that many prescribers will fall into the category 
of small entities (e.g., offices of optometrists less than $7.5 million 
in size).\406\ Determining a precise estimate of the number of small 
entities covered by the Rule's prescription release requirements is not 
readily feasible because most prescribers' offices do not release the 
underlying revenue information necessary to make this 
determination.\407\ Based on its knowledge of the eye care industry, 
staff believes that a substantial number of these entities likely 
qualify as small businesses. The Commission seeks comment with regard 
to the estimated number or nature of small business entities, if any, 
for which the proposed amendments would have a significant impact.
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    \406\ 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.
    \407\ 5 U.S.C. 601(6).
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D. Projected Reporting, Recordkeeping, and Other Compliance 
Requirements, Including Classes of Covered Small Entities and 
Professional Skills Needed To Comply

    As explained earlier in this document, the proposed amendments 
require that prescribers obtain from patients, and maintain for a 
period of not less than three years, a signed acknowledgment form, 
entitled ``Patient Receipt of Contact Lens Prescription,'' confirming 
that patients received their contact lens prescriptions at the 
completion of their contact lens fitting.
    The small entities potentially covered by these proposed amendments 
will include all such entities subject to the Rule. The professional 
skills necessary for compliance with the Rule as modified by the 
proposed amendments will include office and administrative support 
supervisors to create the acknowledgment form and clerical personnel to 
collect signatures from patients and maintain records. The Commission 
believes the burden imposed on small businesses by these requirements 
is relatively small, for the reasons described previously in Section

[[Page 88559]]

VIII of this notice. The Commission invites comment and information on 
these issues, including estimates or data on specific compliance costs 
that small entities might be expected to incur.

E. Duplicative, Overlapping, or Conflicting Federal Rules

    The Commission has not identified any other federal statutes, 
rules, or policies duplicating, overlapping, or conflicting with the 
proposed amendments, but as noted previously, the majority of states 
already require that optometrists--of which many are most likely small 
businesses--maintain records of eye examinations for at least three 
years. The Commission invites additional comment on this issue.

F. Significant Alternatives to the Proposed Amendments

    The Commission has not proposed any specific small entity exemption 
or other significant alternatives, as the proposed amendments clarify 
and update the Rule in light of marketplace practices to ensure that 
patients are receiving a copy of their contact lens prescription at the 
completion of a contact lens fitting. Under these limited 
circumstances, the Commission does not believe a special exemption for 
small entities or significant compliance alternatives are necessary or 
appropriate to minimize the compliance burden, if any, on small 
entities while achieving the intended purposes of the proposed 
amendments. As discussed above, the proposed recordkeeping requirement 
likely involves minimal burden and prescribers would be permitted to 
maintain records in either paper or electronic format. This 
recordkeeping burden could be reduced to the extent that prescribers 
have adopted electronic medical record systems, especially those where 
patient signatures can be recorded electronically and input 
automatically into the electronic record. Furthermore, prescribers also 
could scan signed paper copies of the acknowledgment form and store 
those forms electronically to lower the costs of this recordkeeping 
requirement. Nonetheless, the Commission seeks comment on the need, if 
any, for alternative compliance methods to reduce the economic impact 
of the Rule on small entities. If the comments filed in response to 
this NPRM identify small entities affected by the proposed amendments, 
as well as alternative methods of compliance that would reduce the 
economic impact of the proposed amendments on such entities, the 
Commission will consider the feasibility of such alternatives and 
determine whether they should be incorporated into the final Rule.

X. Proposed Rule Language

List of Subjects in 16 CFR Part 315

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

    Under 15 U.S.C 7601-7610 and as discussed in the preamble, the 
Federal Trade Commission proposes to amend title 16 of the Code of 
Federal Regulations by revising part 315 as follows:

PART 315--CONTACT LENS RULE

0
1. The authority citation for part 315 continues to read as follows:

    Authority:  Pub. L. 108-164, secs. 1-12; 117 Stat. 2024 (15 
U.S.C. 7601-7610).

0
2. Amend Sec.  315.3 by adding paragraph (c) to read as follows:


Sec.  315.3  Availability of contact lens prescriptions to patients.

* * * * *
    (c) Acknowledgment of prescription release. Upon completion of a 
contact lens fitting, and after providing a copy of the contact lens 
prescription to the patient, the prescriber:
    (1) Shall request that the contact lens patient acknowledge receipt 
of the contact lens prescription by signing an acknowledgment form 
entitled, ``Patient Receipt of Contact Lens Prescription'' that states, 
``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.''
    (2) The acknowledgment form shall include, in addition to the title 
and statement specified in paragraph (c)(1), the name of the patient, 
the patient signature, and the date executed. In the event that the 
patient declines to sign the acknowledgment form, the prescriber shall 
note the patient's refusal on the form and sign it. No other statements 
or information, other than the address or letterhead of the prescriber, 
shall be placed on the acknowledgment form.
    (3) The prescriber shall maintain the signed acknowledgments 
received under paragraph (c)(1) for a period of not less than three (3) 
years, and such signed acknowledgments shall be available for 
inspection by the Federal Trade Commission, its employees, and its 
representatives.
0
3. Amend Sec.  315.5 paragraph (e) by revising the second sentence to 
read as follows:


Sec.  315.5   Prescriber verification.

* * * * *
    (e) * * * Notwithstanding the preceding sentence, a seller may 
substitute for contact lenses specified on a prescription identical 
contact lenses that the same company manufactures and sells under 
different labels.
* * * * *

    By direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. 2016-28471 Filed 12-6-16; 8:45 am]
 BILLING CODE 6750-01-P