# Contact Lens Rule > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3A2016-28471 ## Record - **Collection:** Federal Register - **Document type:** Proposed Rule - **Published:** December 7, 2016 - **Citation:** 81 FR 88526 ## Text 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. 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. 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 3 16 CFR 315.3(b). 4 16 CFR 315.4. 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 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 5 16 CFR 315.5(a). 6 16 CFR 315.5(b)-(c). 7 16 CFR 315.5(d). 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 8 16 CFR 315.5(e). 9 16 CFR 315.7. 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 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). 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 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. 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. 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 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). 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 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). Prescribers also are required to provide or verify a contact lens 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. 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. 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. 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. 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 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 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. 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 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. 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. 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. 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. 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 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 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 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. 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 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 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 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 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 § 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. 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 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 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 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 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, § 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 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' 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 so [Text truncated at 120,000 characters. The full text is on the page linked above.] --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A2016-28471. Public record. Not legal advice.