Contact Lens Rule

Federal RegisterMay 28, 2019

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FEDERAL TRADE COMMISSION

16 CFR Part 315

RIN 3084-AB36

Contact Lens Rule

AGENCY:

Federal Trade Commission (“FTC” or “Commission”).

ACTION:

Supplemental notice of proposed rulemaking; request for public comment.

SUMMARY:

As part of its regulatory review of the Contact Lens Rule (“Rule”), the Commission is proposing modifications to its prior proposal to amend the Rule to require that prescribers obtain a signed acknowledgment after releasing a contact lens prescription and maintain each such acknowledgment for a period of not less than three years. The Commission is further proposing to amend the Rule to: Permit prescribers to comply with automatic prescription release via electronic delivery in certain circumstances; specify a time-period for prescribers to respond to requests for prescriptions; clarify and institute additional requirements for automated telephone verification messages; more precisely delineate what constitutes unlawful alteration of a prescription; and require that sellers accept patient prescription presentation. The Commission seeks comment on these proposals. The Commission is not adopting any final amendments to the Rule at this time and continues to consider comments and information submitted in response to its Request for Comment of September 2015, its Notice of Proposed Rulemaking of December 2016, and its Notice Announcing Public Workshop and Request for Comment of December 2017.

DATES:

Written comments must be received on or before July 29, 2019.

ADDRESSES:

Interested parties may file a comment online or on paper by following the instructions in the Request for Comment part of the

SUPPLEMENTARY INFORMATION

section below. Write “Contact Lens Rule Review, 16 CFR part 315, Project No. R511995” on your comment, and file your comment online at

https://www.regulations.gov

by following the instructions on the web-based form. If you prefer to file your comment on paper, mail your comment to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW, Suite CC-5610 (Annex B), Washington, DC 20580, or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW, 5th Floor, Suite 5610 (Annex B), Washington, DC 20024.

FOR FURTHER INFORMATION CONTACT:

Alysa Bernstein, Attorney, (202) 326-2903, Paul Spelman, Attorney, (202) 326-2487, or Andrew Wone, Attorney, (202) 326-2934, Division of Advertising Practices, Bureau of Consumer Protection, Federal Trade Commission, 600 Pennsylvania Avenue NW, Washington, DC 20580.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background

A. Overview of the Contact Lens Rule

B. History of the Rule

C. Initial Request for Comments in 2015

D. Notice of Proposed Rulemaking in 2016

II. Supplemental Notice of Proposed Rulemaking

A. Proposal To Modify Prior Signed-Acknowledgement Proposal

B. New Proposals To Modify the Rule

III. Option for Electronic Delivery of Prescriptions as a Means for Automatic Prescription Release

A. Use of Patient Portals by Prescribers and Patients

B. Analysis and Proposal

IV. Modification of Prior Signed-Acknowledgement Proposal

A. NPRM Automatic Prescription Release Proposal and Comments

B. Comments on the Proposed Amendment to § 315.3(a)(1)

1. General Comments

2. Comments Concerning the Need for the Proposed Signed Acknowledgment Due to Non-Compliance

a. Empirical Evidence of Compliance

b. Verifications as Evidence of Lack of Prescription Release

c. The Dearth of Consumer Complaints to the FTC as Evidence of Prescriber Compliance

3. Comments Concerning Whether a Proposed Signed Acknowledgment Is Needed for Better Enforcement and Auditing of the Rule

4. Comments About the Burden of the Signed-Acknowledgment Proposal

5. Comments on the Text of the Proposed Acknowledgment Form

6. Alternative Proposals to the Signed-Acknowledgment Proposal

C. Additional Discussion and Proposal

1. A Confirmation From the Consumer Is Necessary for Enforcement and Monitoring

2. The Burden Is Relatively Small and Outweighed by the Benefits

3. Analysis and Proposal

V. Requiring Prescribers To Respond to Requests for an Additional Copy of a Prescription Within Forty Business Hours

A. Obtaining an Additional Copy of a Prescription

B. Analysis and Proposal

VI. Additional Requirements for Sellers Using Automated Telephone Verification Messages

A. Issues With Automated Telephone Verification Messages

B. Analysis and Proposal

VII. Seller Alteration of Contact Lens Prescriptions

A. Background

B. Comments

C. Analysis and Proposals

1. Seller Requirement To Accept Prescription Presentation

2. Seller Requirement To Verify Only the Contact Lens Brand or Manufacturer That Consumers Indicate Is on Their Prescriptions

VIII. Request for Comments

A. General Questions on Proposed Amendments

B. Electronic Delivery of Prescriptions

C. Confirmation of Prescription Release

D. Prescriber Responses to Requests for an Additional Copy of a Prescription

E. Automated Telephone Verification Messages

F. Illegal Prescription Alteration

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

X. Paperwork Reduction Act

A. Estimated Additional Hours Burden

B. Estimated Total Labor Cost Burden

C. Capital and Other Non-Labor Costs

XI. Regulatory Flexibility Act

A. Description of the Reasons the Agency Is Taking Action

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

C. Small Entities to Which the Proposed Amendments Will Apply

D. Projected Reporting, Recordkeeping, and Other Compliance Requirements, Including Classes of Covered Small Entities and Professional Skills Needed to Comply

1. Amendments Affecting Prescribers

2. Amendments Affecting Sellers

E. Duplicative, Overlapping, or Conflicting Federal Rules

F. Significant Alternatives to the Proposed Amendments

1. Alternatives for Amendments Affecting Prescribers

2. Alternatives for Amendments Affecting Sellers

I. Background

A. Overview of the Contact Lens Rule

In 2003, Congress enacted the Fairness to Contact Lens Consumers Act,

and pursuant to the Act, the Commission promulgated the Contact Lens Rule on July 2, 2004.

The Rule went into effect on August 2, 2004.

15 U.S.C. 7601-7610 (Pub. L. 108-164).

Contact Lens Rule, 16 CFR part 315 (2015).

The Contact Lens Rule promotes competition in retail sales of contact lenses by facilitating consumers' ability to comparison shop for contact lenses. When a prescriber completes a contact lens fitting, the Rule requires that the prescriber automatically provide the patient with a portable copy of the patient's prescription, whether or not the patient requests it. The Rule also

requires that the prescriber verify or provide such prescriptions to authorized third parties. At the same time, the Rule requires that sellers only sell contact lenses in accordance with valid prescriptions written by licensed prescribers that were either (a) presented to the seller by the patient or a designated agent of the patient or (b) verified by direct communication with the prescriber.

16 CFR 315.5(a).

The Rule further sets out the information that must be included in a seller's verification request, and directs that a prescription is only verified under the Rule if: (1) A prescriber confirms the prescription is accurate; (2) a prescriber informs the seller that the prescription is inaccurate and provides an accurate prescription in its stead; or (3) the prescriber fails to communicate with the seller within eight business hours after receiving a compliant verification request.

The Rule states that if the prescriber informs the seller within eight business hours of receiving the verification request that the prescription is inaccurate, expired, or invalid, the seller shall not fill the prescription. The Rule requires that the prescriber specify the basis for the inaccuracy or invalidity of the prescription, and if the prescription is inaccurate, the prescriber must correct it.

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.

16 CFR 315.5(b)-(c).

16 CFR 315.5(d).

16 CFR 315.5(e).

The Contact Lens Rule sets a minimum expiration date of one year after the issue date of a prescription with an exception based on a patient's ocular health.

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.

16 CFR 315.6.

16 CFR 315.11(a). The Rule states further that “[a]ny other state or local laws or regulations that are inconsistent with the Act or this part are preempted to the extent of the inconsistency.” 16 CFR 315.11(b).

B. History of the Rule

The FTC has more than three decades of regulatory and research experience regarding the optical goods industry; this history continues to inform the basis and purpose of the Contact Lens Rule and this rule review. In addition to the Rule, the Commission enforces the Ophthalmic Practice Rules (known as the “Eyeglass Rule”), initially promulgated in 1978.

Prior to the Eyeglass Rule, many prescribers either refused to release prescriptions to their patients or charged an additional fee to do so.

Prescribers also used waivers and liability disclaimers to discourage comparison shopping, mislead consumers, and frighten them into purchasing ophthalmic goods from the prescriber.

The Commission determined that these actions reduced consumers' ability to obtain the lowest prices and hindered competition in the optical marketplace.

To address these problems, the Eyeglass Rule required prescribers—generally, optometrists and ophthalmologists—to provide each of their patients, immediately after completion of an eye examination, a free copy of the patient's eyeglass prescription.

Final Trade Regulation Rule, Advertising of Ophthalmic Goods and Services, 43 FR 23992 (June 2, 1978) [hereinafter Eyeglass I]. The Rule was revised in 1992, with the revisions codified at 16 CFR part 456. Ophthalmic Practice Rules, 57 FR 18822 (May 1, 1992).

43 FR at 23998. The Commission found, for example, that in nearly every survey of practicing optometrists considered in the rulemaking record, more than 50% of optometrists imposed a restriction on the availability of eyeglass prescriptions to patients.

See also

FTC, “Staff Report on Advertising of Ophthalmic Goods and Services and Proposed Trade Regulation Rule” 240-48 (1977) [hereinafter 1977 Staff Report] (detailing myriad accounts of prescribers refusing to release eyeglass prescriptions to their patients),

https://www.ftc.gov/system/files/documents/reports/staff-report-advertising-ophthalmic-goods-services-proposed-trade-regulation-rule-16-cfr-part-456/r611003_-_staff_report_on_advertising_of_ophthalmic_goods_and_services_and_proposed_trade_regulation.pdf.

Am. Optometric Ass'n

FTC,

626 F.2d 896, 916 (D.C. Cir. 1980) (noting considerable “evidence of abuse” by prescribers);

See also

Letter from Senators Richard Blumenthal and Orrin G. Hatch of the United States Senate Regarding the Contact Lens Rule Rulemaking Proceeding and the Proposed Rule Set Forth in the Notice of Proposed Rulemaking (Aug. 11, 2017) (recognizing the “inherent conflict of interest” and noting that the FCLCA was made necessary by “the unique nature of the contact lens marketplace”),

https://www.ftc.gov/system/files/filings/initiatives/677/

public_comment_from_senators_blumenthal_and_hatch_re_contact_lens_rulemaking.pdf

[hereinafter Blumenthal Letter].

H.R. Rep. No. 108-318, at 5

;

FCLCA Subcomm. Hearing (statements of Rep. W.J. Tauzin (LA)) (noting there is a “classic conflict of interest that robs the consumers of the ability to shop competitively for the best price,” and stating that the FCLCA takes the “necessary steps to remedy this stranglehold on contact lens competition.”).

15 U.S.C. 7601-7610 (Pub. L. 108-164).

Contact Lens Rule, 69 FR 40482 (July 2, 2004) (codified at 16 CFR part 315). Pursuant to its congressional mandate, the FTC also issued a study of competition in the contact lens industry in 2005.

See

2005 Contact Lens Report,

supra

note 12.

As specified in the Act, the Rule imposes requirements on both sellers and prescribers of contact lenses. Because the use of contact lenses involves significant health issues

and Congress recognized that consumers may be harmed by contact lenses purchased with an expired, inaccurate, or otherwise invalid prescription,

the Act requires that contact lenses be sold only to patients with valid prescriptions, which they receive after contact lens fittings by a prescriber. The Act and the Rule only allow sales of contact lenses when a patient presents a seller with a copy of the prescription or the seller has verified the patient's prescription with the prescriber.

Sellers also are prohibited from altering a contact lens prescription.

See, e.g.,

FTC, “Possible Barriers to E-Commerce: Contact Lenses, A Report from the Staff of the Federal Trade Commission” 8-9 (2004),

http://www.ftc.gov/os/2004/03/040329clreportfinal.pdf.

Contact Lens Rule, 69 FR 40482.

16 CFR 315.5(a).

16 CFR 315.5(e).

The Act and the Rule further impose obligations on prescribers. First and foremost, prescribers are required to release a copy of the prescription to the patient promptly upon completion of the contact lens fitting, “[w]hether or not requested by the patient.”

Prescribers also are prohibited from requiring: (1) The purchase of contact lenses as a condition of either prescription release or verification, (2) a separate payment for prescription release or verification, and (3) that the patient sign a waiver as a condition of prescription release or verification.

15 U.S.C. 7601(a)(1); 16 CFR 315.3(a)(1).

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

Additionally, prescribers are required to provide or verify a contact lens prescription when “directed by any person designated to act on behalf of the patient.”

Such verification occurs when the seller provides the prescriber with a consumer's prescription information and: (1) The prescriber confirms that the prescription is accurate, by phone, facsimile, or electronic mail; (2) the prescriber informs the seller that the prescription is inaccurate and provides the correct prescription; or (3) the prescriber does not communicate with the seller within eight business hours of the seller's request for verification (“passive verification”).

The eight-business-hour passive verification lessens the demands on prescribers in the event a seller forwards a query about an accurate and complete prescription from a properly identified patient. It also prevents prescribers from blocking verification—and impeding consumer access to contact lenses that may be lower-priced, or sold by sellers who offer other benefits or convenience—simply by refusing to respond to verification requests.

15 U.S.C. 7601(a)(2) (must, as directed by authorized party, “provide or verify” the prescription); 16 CFR 315.3(a)(2).

15 U.S.C. 7603(d)(1)-(3); 16 CFR 315.5.

One outcome of passive verification, however, if a prescriber does not respond to a verification request containing inaccurate information or for an invalid prescription within eight business hours is that the prescription is deemed verified; thus, passive verification allows for the possibility that patients can be sold lenses for which they do not have a valid prescription. Congress, when considering the FCLCA, was aware that a passive-verification regime could, in some instances, allow sellers to sell and ship contact lenses based on an invalid or inaccurate prescription, and that this could potentially lead to health risks.

Congress opted for a passive-verification regime despite this concern in order “to ensure that consumers are not caught in the competitive tug-of-war between doctors and third party sellers for the sale of contact lenses.”

It was also envisioned that prescribers would remain diligent in ensuring that patients did not receive lenses for which they had not been prescribed, since it is in both prescribers' self-interest and the health and safety interests of their patients to prevent this from occurring.

In this manner, the passive-verification system was perceived, to a certain extent, to be self-enforcing, as prescribers would have both a financial interest and an ethical duty to police invalid, incorrect, or expired prescriptions.

See, e.g.,

FCLCA Subcomm. Hearing,

supra

note 15 (statements of Howard Beales, Federal Trade Commission);

Id.

(statements of J. Pat Cummings, American Optometric Association) (“And the problem with passive verification is that people will get contact lenses without a prescription.”).

H.R. Rep. No. 108-318, at 5.

Contact Lens Rule, 69 FR at 40498.

FCLCA Subcomm. Hearing,

supra

note 15 (statements of Howard Beales, Federal Trade Commission) (stating that passive verification is in many respects self-enforcing).

See also

FCLCA Subcomm. Hearing,

supra

note 15 (statements of Jonathan Coon, 1-800 CONTACTS) (explaining to the Committee that from their experience with an existing passive verification-system in California, doctors have a motivation to block invalid-prescription sales. “So they tell us if there is any problem with the prescription, if it's expired, it's invalid, whatever the problem is with the prescription. If they can tell us, you can believe they tell us absolutely every time.”).

C. Initial Request for Comments in 2015

As part of its periodic review of its rules and guides, on September 3, 2015, the Commission solicited comments on the Contact Lens Rule, seeking input on: The economic impact of, and continuing need for, the Rule; the benefits of the Rule to consumers purchasing contact lenses; the burdens the Rule places on entities subject to its requirements; the impact the Rule has had on the flow of information to consumers; the degree of industry compliance with the Rule; the need for any modifications to increase its benefits or reduce its burdens or to account for changes in relevant technology; and any overlap or conflict with the Rule and other federal, state, or local laws or regulations.

The comment period closed on October 26, 2015. The Commission received approximately 660

comments from individuals and entities representing a wide range of viewpoints, including prescribing eye-care practitioners (ophthalmologists and optometrists), opticians and other eye-wear industry members, sellers of contact lenses (both online and brick-and-mortar), contact lens manufacturers, and consumers.

Contact Lens Rule, 80 FR 53272 (Sept. 3, 2015).

Comment figures are approximations because identical comments are sometimes submitted more than once.

D. Notice of Proposed Rulemaking in 2016

After a review of comments, surveys, other submitted information, and its own enforcement experience, the Commission determined that the overall weight of the evidence demonstrated a

need to improve compliance with the Rule's automatic prescription-release requirement, as well as a need to create a mechanism for monitoring and enforcing the Rule.

To achieve this, the Commission issued a Notice of Proposed Rulemaking (“NPRM”) on December 7, 2016 that proposed to add a signed-acknowledgment requirement.

The signed-acknowledgment requirement would be triggered once the prescriber presented the prescription to the patient, and the acknowledgment form could be in either paper or electronic format. As proposed, the acknowledgment form would be entitled “Patient Receipt of Contact Lens Prescription,” and state, “My eye care professional provided me with a copy of my contact lens prescription at the completion of my contact lens fitting. I understand that I am free to purchase contact lenses from the seller of my choice.” Prescribers would be required to maintain copies of the acknowledgment forms in paper or electronically for not less than three years.

Notice of Proposed Rulemaking, 81 FR 88526 (Dec. 7, 2016) [hereinafter NPRM].

Id.

The NPRM also proposed a technical amendment, to remove the words “private label” from § 315.5(e) to conform the language of the Rule to that of the FCLCA, but that amendment is not at issue in this Supplemental Notice of Proposed Rulemaking.

The NPRM sought comment on this proposal, and also about the following issues: The provision of additional copies of prescriptions, the amount of time for a prescriber to respond to such a request, the use of patient portals to release prescriptions, and potential modifications to address concerns about automated telephone verification calls. The sixty-day comment period for the Commission's NPRM closed on January 30, 2017.

In response to its NPRM, the Commission received over 4,000 additional comments, many from prescribers concerned about the impact of the proposed signed- acknowledgment requirement. After considering these and other comments, the Commission determined that certain issues deserved additional discussion and examination. To obtain additional input and more fully consider commenter concerns, the Commission solicited additional comments

and held a public workshop on the Contact Lens Rule and the Evolving Contact Lens Marketplace on March 7, 2018. The workshop included six panels, covering issues relating to the overall contact lens marketplace, health and safety, competition, purchasing and verification, the proposed signed acknowledgment and consumer choice, and the future of contact lens prescribing and selling. In response to the Commission's request and workshop, the Commission received approximately 3,400 additional comments from a wide range of commenters, including numerous consumers and prescribers, as well as industry associations, state attorneys general, contact lens manufacturers, and retailers.

Public Workshop Examining Contact Lens Marketplace and Analyzing Proposed Changes to the Contact Lens Rule, 82 FR 57889 (Dec. 8, 2017).

II. Supplemental Notice of Proposed Rulemaking

After reviewing the comments, the Commission now proposes to modify its prior proposal—put forth in the NPRM—that would have required prescribers to request a signed statement from their patients acknowledging receipt of the patient's prescription. The Commission also proposes new amendments to the Rule. This Supplemental Notice of Proposed Rulemaking (“SNPRM”) summarizes the relevant comments received and explains the Commission's proposal to modify its signed-acknowledgment proposal and amend other sections of the Rule.

This SNPRM will only discuss comments specifically related to the modifications and amendments proposed at this time. The Commission will address other issues raised by commenters when the Commission issues its Final Rule.

A. Proposal To Modify Prior Signed-Acknowledgment Proposal

The Commission proposes to modify its prior proposal for a signed-acknowledgment requirement by instituting a more flexible Confirmation of Prescription Release provision. Rather than requiring that prescribers request that each contact lens patient acknowledge receipt of the prescription by signing a form stating, “My eye care professional provided me with a copy of my contact lens prescription at the completion of my contact lens fitting. I understand I am free to purchase contact lenses from the seller of my choice,”

prescribers would be required to do one of the following:

NPRM, 81 FR at 88559.

(a) Request that the patient acknowledge receipt of the contact lens prescription by signing a separate statement confirming receipt of the contact lens prescription;

(b) Request that the patient sign a prescriber-retained copy of a contact lens prescription that contains a statement confirming receipt of the contact lens prescription;

(c) Request that the patient sign a prescriber-retained copy of the sales receipt for the examination that contains a statement confirming receipt of the contact lens prescription; or

(d) If a digital copy of the prescription was provided to the patient (via methods including an online portal, electronic mail, or text message), retain evidence that such prescription was sent, received, or made accessible, downloadable, and printable.

The precise wording of such confirmations would be left to the prescriber's discretion, but for prescribers opting for (a), (b), or (c), a patient's written or electronic signature would always be required. The prescriber would have to maintain evidence of the Confirmation of Prescription Release for at least three years, and make such evidence available upon request by the Commission. Unlike the Commission's prior acknowledgment proposal, which applied to all prescribers, the Confirmation of Prescription Release would only be required of prescribers who have a financial interest in the sale of contact lenses.

B. New Proposals To Modify the Rule

In addition to the proposed Confirmation of Prescription Release, the Commission further proposes to modify the Rule for prescribers and sellers in several ways. First, by adding to the Rule a definition of the term “provide to the patient a copy,” the Commission proposes to allow the prescriber, with the patient's verifiable affirmative consent, to provide the patient with a digital copy of the patient's prescription in lieu of a paper copy. Second, although the Rule has always required that prescribers, upon request, provide any person designated to act on behalf of the patient with a copy of the patient's valid contact lens prescription, the Rule did not prescribe a time limit in which the copy of the prescription had to be provided; the Commission now proposes forty business hours as a reasonable time period in which the prescription must be provided. The prescriber would also be required to note the name of the requester and the date and time the prescription was provided.

Third, the Commission also now proposes new requirements for sellers using automated telephone verification messages. The proposal would require a seller to (1) record the entire call and preserve the complete recording; (2) begin the call by identifying it as a prescription verification request made in accordance with the Contact Lens Rule; (3) deliver the verification

message in a slow and deliberate manner and at a reasonably understandable volume; and (4) make the message repeatable at the prescriber's option. To aid implementation of this proposal, the Commission further proposes to add definitions for the terms “reasonably understandable volume,” and “slow and deliberate manner.” The purpose of this amendment is to enable prescribers to fulfill their role as protectors of patients' eye health, since prescribers cannot correct and police invalid, inaccurate, and expired prescriptions if they cannot comprehend a seller's verification request. By requiring preservation of the recording, the amendment will also enable the Commission to better monitor seller compliance with the Rule.

Fourth, the Commission proposes to amend the prohibition on seller alteration of prescriptions by specifying that alteration includes a seller providing the prescriber a verification request with the name of a manufacturer or brand other than that specified by the patient's prescriber, unless such name is provided because the patient entered it on the seller's order form, or because the patient orally gave the seller the other name in response to a request for the manufacturer listed on the patient's prescription.

Lastly, in order to limit the burden of verification and ensure patient choice and flexibility, the Commission proposes to amend the Rule by requiring that sellers provide a mechanism that would allow patients to present their prescriptions directly to the seller.

III. Option for Electronic Delivery of Prescriptions as a Means for Automatic Prescription Release

In the NPRM, the Commission concluded that using online-patient portals to complete the automatic prescription release offered potential benefits for sellers, prescribers, and patients.

Prescribers could post, and patients could obtain, prescriptions online. With an electronic copy, patients could provide prescriptions more easily to sellers when purchasing lenses.

In turn, this potentially would reduce the volume of requests by sellers for verification or additional copies of the prescription.

To facilitate portability, the Commission noted that portals should allow patients to download, save, and print the prescription as well as send the prescription directly to a seller. However, the Commission did not have sufficient information to determine whether solely posting a contact lens prescription on a patient portal would be sufficient to satisfy the Rule's obligation for prescribers to provide a copy of a prescription to patients after completing a contact lens fitting. Therefore, the Commission sought comment on the use and adoption of online-patient portals as well as the potential ability for such technology to allow prescribers to comply with the automatic prescription-release requirement.

NPRM, 81 FR at 88535.

Id.

In the NPRM, the Commission also clarified that the “directly or by facsimile” language of § 315.5(a)(1) includes the use of online portals by patients and prescribers to present contact lens prescriptions to sellers. The Commission sought comments on this clarification. While the Commission received some comments, the Commission does not believe that any further modifications to this provision are necessary.

A. Use of Patient Portals by Prescribers and Patients

In response, several commenters noted the benefits and supported the use of patient portals.

Through a portal, patients would have greater access to their prescriptions and would have electronic copies to send to sellers.

However, commenters also expressed concerns that: (1) Online portals are not widely used; (2) patients may not be aware of the portal or may have difficulty accessing or printing medical documents online; and (3) prescribers and patients prefer paper copies.

Another commenter was concerned that allowing prescribers to satisfy the automatic prescription release by using an online portal would undercut the signed-acknowledgment requirement proposed in the NPRM.

Opticians Association of America (Workshop [hereinafter WS] Comment #482); CooperVision, Inc. (WS Comment #3077); Coalition for Contact Lens Consumer Choice (WS Comment #3239); Grove (NPRM Comment #1702); Opternative (NPRM Comment #3785); Comments of the Attorneys General of 20 States (NPRM Comment #3804); American Optometric Association (NPRM Comment #3830) (“For those doctors who have functioning patient portals and for patients who would like to use them, it would be beneficial for the Commission to clarify that providing access to a contact lens prescription through the patient portal would meet the prescriber requirements of automatic prescription release”); National Association of Optometrists and Opticians (NPRM Comment #3851); Costco Wholesale Corporation (NPRM Comment #4281) (“Patient portals are now commonplace among physician practices and could serve to enhance compliance with the Rule, as well as provide better information to sellers”).

See also

American Academy of Ophthalmology (NPRM Comment #3657) (some prescribers currently provide copies of prescriptions electronically, including through patient portals).

Opternative (NPRM Comment #3785); American Optometric Association (NPRM Comment #3830); 1-800 CONTACTS (NPRM Comment #3898); Consumers Union (NPRM Comment #3969) (“We see significant potential advantages of providing the

prescription

to the patient in electronic form, whether by email attachment or online patient portal.”).

Opternative (NPRM Comment #3785); American Optometric Association (NPRM Comment #3830); 1-800 CONTACTS (NPRM Comment #3898); Consumers Union (NPRM Comment #3969).

1-800 CONTACTS (NPRM Comment #3898).

The Act and Rule clearly envision and support the use of electronic means to convey prescriptions. This is evident by the language of Section 7601(a)(2) of the Act, which requires prescribers to “provide or verify the contact lens prescription by electronic or other means” to patients' agents.

It would be inconsistent for the Act and Rule to permit prescribers to provide prescriptions electronically to patients' agents, but prohibit prescribers from electronically conveying prescriptions to patients themselves (or require that patients formally designate themselves as their own agent in order to receive an electronic copy of their prescription).

15 U.S.C. 7601(a)(2); 16 CFR 315.3(a)(2).

Although online access to records has increased in the medical field generally,

the prevalence of portals among eye-care providers is unclear.

However, portal usage could increase as patients become more comfortable in interacting with their medical providers online and portal capabilities improve.

Several eye-care providers already offer copies of prescriptions through patient portals or other electronic means, including email.

One survey from 2017 found that 52% of individuals were offered online access to their medical records by a health provider or insurer, an increase from 42% in 2014. Of those patients who were offered online access, more than half actually viewed their online medical records at least once in the past year. U.S. Dep't of Health & Human Servs., The Office of the National Coordinator for Health Information Technology, “Individuals' Use of Online Medical Records & Technology for Health Needs” 1-2 (2018).

According to a survey conducted by 1-800 CONTACTS, thirty percent of patients were offered the option to use a patient portal at their last eye exam and, of those who had the option, 29% actually used it. 1-800 CONTACTS (NPRM Comment #3898). Comparatively, at the March 7, 2018 workshop, a panelist commented that only 8% of his office's patients used the portal. FTC, The Contact Lens Rule and the Evolving Contact Lens Marketplace, Panel V: Prescription Release & Consumer Choice Tr. at 17 (Mar. 7, 2018),

https://www.ftc.gov/system/files/documents/public_events/1285493/panel_v_prescription_release_and_consumer_choice.pdf

[hereinafter CLR Panel V Tr.].

CLR Panel V Tr.,

supra

note 50, at 18-19.

See, e.g.,

Eklund (WS Comment #502); Reed (WS Comment #749); Gitchell (WS Comment #759); Andrews (WS Comment #1014); Carvell (WS Comment #1021); Cecil (WS Comment #1892); Kuryan (WS Comment #3472); Hopkins (NPRM Comment #184); Wilson (NPRM Comment #1310); Grove (NPRM Comment #1702); MacDonald (NPRM Comment #2118); Andrus (NPRM Comment #3345); American Academy of Ophthalmology (NPRM Comment #3657) (“For practices that utilize electronic medical record systems, patients can

request a copy of their prescription and [be] issued one electronically. Many practices also utilize patient portals to fill prescription requests.”).

B. Analysis and Proposal

Based on its review of the evidence, the Commission believes that the Rule should be amended to allow prescribers to satisfy § 315.3(a)(1)'s automatic-release requirement by providing the patient with a digital copy of the prescription, including by email, text, or patient portal, in lieu of a paper copy.

Importantly, the choice is not whether patients want to receive their prescriptions—since the Rule and statute both require that this be automatic—but rather the method of receiving them. To ensure that patients are not required to accept an unwanted method of delivery, the Commission would limit the use of electronic means to instances where the patient has given affirmative consent to receive a digital copy of the prescription.

The consent must be verifiable (so oral consent alone would not suffice), and the patient must be able to access, download, and print the digital copy for future use. Patients who decline to consent, for any reason, must receive a paper copy of their prescription. Likewise, because technology may be developing still or be costly to implement, prescribers who prefer to provide paper copies to their patients need not offer an electronic option. Therefore, the Commission invites comments on its proposed modification to allow prescribers to satisfy the automatic prescription release requirement by providing a digital copy in lieu of a paper copy when the patient gives verifiable affirmative consent.

In the NPRM, the Commission stated that allowing patients to send prescriptions to sellers through the portal would promote prescription portability. NPRM, 81 FR at 88535. Although potentially beneficial, the Commission's proposed change does not require that patients be able to send prescriptions to sellers through the portals. The technology that would allow this type of communication is still evolving, and potential complications exist, including software differences, the number of prescribers and sellers involved, and privacy issues. 1-800 CONTACTS (NPRM Comment #3898); CLR Panel V Tr.,

supra

note 50, at 19-20.

The proposed change to allow for a digital copy in lieu of a paper copy does not alter the timing of when a prescriber must provide the prescription to the patient. In both instances, whether digital or paper, prescribers must provide the prescription immediately after completion of the contact lens fitting, or in the case of a renewal prescription, when the prescriber determines that no change in the existing prescription is required. The Commission's proposal would not expressly require that prescribers maintain records of patients' affirmative consent to electronic delivery, but prescribers may choose to do so in order to have proof that affirmative consent was given. Furthermore, the Commission's proposal would not alter or pre-empt existing state and federal statutes pertaining to the electronic delivery of records, such as the Electronic Signatures in Global and National Commerce Act, 15 U.S.C. 7001 (“E-Sign”).

Proposed changes to § 315.5(c) would require prescribers who provide digital copies of prescriptions to patients to retain evidence that the prescription was sent, received, or made accessible, downloadable, and printable.

IV. Modification of Prior Signed-Acknowledgment Proposal

A. NPRM Automatic Prescription Release Proposal and Comments

In its December 2016 NPRM, the Commission proposed amending § 315.3(a)(1)—Automatic Prescription Release—to add the requirement that upon completion of a contact lens fitting, and after providing a copy of the contact lens prescription to the patient, the prescriber request that the contact lens patient acknowledge receipt of the contact lens prescription by signing an acknowledgment form entitled, “Patient Receipt of Contact Lens Prescription.” This form would state, “My eye care professional provided me with a copy of my contact lens prescription at the completion of my contact lens fitting. I understand I am free to purchase contact lenses from the seller of my choice.” In addition, the form would also include the name of the patient, the patient signature, and the date the form was signed. If the patient declined to sign the acknowledgment form, the prescriber would note the patient's refusal on the form and sign it. No other statements or information, other than the address or letterhead of the prescriber, would be placed on the acknowledgment form.

The Commission based its proposal on multiple findings. First, the Commission noted that commenters cited or submitted five surveys which, taken as a whole, suggested that a significant percentage of consumers were not receiving their prescriptions, and were unaware of their right to receive them.

The Commission acknowledged that none of the surveys, in and of itself, could be considered definitive, and acknowledged that there are inherent limitations to survey evidence.

Even so, the Commission concluded that the evidence was sufficient to indicate a significant problem with prescription-release compliance, particularly when the surveys were viewed in conjunction with supporting evidence from other sources and the lack of contradictory evidence.

NPRM, 81 FR at 88535.

NPRM, 81 FR at 88531-32.

Id.

NPRM, 81 FR at 88531.

Supporting evidence cited by the Commission consisted of the following: The high number of seller verifications (many of which would be unnecessary were patients in possession of prescriptions and able to present them at purchase);

evidence that consumers are still unaware of their right to their prescriptions;

the ongoing pattern of consumer complaints and anecdotal reports of failure to release prescriptions;

and the industry's long and documented history of opposition to prescription release and failure to provide patients with prescriptions prior to the Rule's enactment, even when so obligated under state law.

The Commission also noted that current enforcement of the automatic-release provision is challenging, since the absence of any documentation makes it difficult to ascertain whether a prescriber did or did not release a prescription, and to determine how frequently a noncompliant party may have violated the Rule.

The Commission noted that under the current Rule, allegations and denials can become a matter of a patient's word against that of their prescriber.

Approximately three-quarters of third-party contact lens sales occur via prescriber verification, meaning that the consumer did not present a complete prescription at the time of the attempted purchase.

Id.

According to an October 2015 survey by Survey Sampling International, an independent market research company retained by commenter 1-800 CONTACTS, 46% of contact lens wearers were unaware that they had a right to receive a copy of their prescription, even though the Rule has been in effect since 2004.

Id.

at 88532.

Id.

at 88533.

Id.

The Commission further concluded that the potential benefits of increasing the number of patients in possession of their prescriptions were substantial: Increased patient flexibility and choice in shopping for lenses; a reduced number of verification requests, which many prescribers find burdensome; a reduced likelihood of errors associated with incomplete or invalid prescriptions, which can jeopardize patient eye health; and a reduction in the number and complications of failed attempts at verification.

Increasing prescription-release compliance also would likely spur competition and innovation among contact lens sellers and manufacturers, and reduce attempts by sellers to verify incorrect, expired, and invalid prescriptions, or to verify with the wrong prescriber.

The Commission determined that the cumulative effect of increased automatic-release compliance would thus be lower costs and improved

convenience and flexibility for patients, sellers, and prescribers, as well as increased accuracy of prescriptions presented to sellers, thereby reducing potential consumer harm.

Furthermore, a signed acknowledgment would increase the Commission's ability to assess and verify compliance with the Rule.

Id.

at 88532.

Id.

at 88533.

The Commission estimated the burden of the proposed requirement at one minute per patient per year to obtain a signed receipt and save it to the patient's file, for a total overall burden on prescribers of 683,333 hours (41 million minutes) per year.

Based on average wages for prescribers, the Commission estimated this would result in an annual cost of $10,475,495,

roughly $176 per prescriber per year.

The Commission did not consider maintaining the form for three years to be a substantial new burden because a majority of state laws already require maintenance of eye exam records, and the Commission felt that maintaining a one-page two-sentence form should not take more than a few seconds of time, and an inconsequential, or

de minimis,

amount of record space.

The Commission concluded that the overall burden of the new requirement was relatively minimal and outweighed by the substantial benefit of having so many more patients in possession of their prescriptions.

Id.

at 88557 (based on a Center for Disease Control and Prevention estimate of 40.9 million contact lens wearers in the U.S.);

See also

Blumenthal Letter,

supra

note 17 (expressing strong support for the signed-acknowledgment provision and applauding the FTC for “proposing pro-consumer and pro-market reforms to the Rule that will ensure robust competition . . . and help improve eye care providers' compliance”).

See e.g.,

Izquierdo (WS Comment #12); Clark (WS Comment #14); Clough (WS Comment #18); Forero (WS Comment #21); Ancona (WS Comment #27); Zeemering (WS Comment #34); Hauck (WS Comment #42); Brown (WS Comment #46); De Soto (WS Comment #49); Taylor (WS Comment #66); Cornwell (WS Comment #77); Chambers (WS Comment #91); Torres-Gambini (WS Comment #106); Hollier (WS Comment #113); Miranda (WS Comment #119); Green (WS Comment #134); Watson (WS Comment #138); Fisher (WS Comment #150); Gover (WS Comment #154); Pike (WS Comment #195); Klauscher (WS Comment #201); Kucewicz (WS Comment #215); Dawson (WS Comment #226); Pfeifer (WS Comment #246); Tennison (WS Comment #428); Florey (NPRM Comment #3520).

Several commenters said the amendment is necessary because the market for contact lenses remains unique in that—unlike most other medical doctors—eye doctors sell the items they prescribe, and thus are rewarded financially for driving patients to their own retail channels.

According to one commenter, “relying on existing market forces and industry professional norms to advance the intent and purposes of the FCLCA and Contact Lens Rule does not work because prescribers have both an incentive and ability to limit consumer choice.”

Information Technology & Innovation Foundation (NPRM Comment #2848); Warby Parker (NPRM Comment #3867).

See also

Arizona State Representative Heather Carter (NPRM Comment #3193) (noting that in 2016, the 10th Circuit Court of Appeals held that the contact lens industry is uniquely anticompetitive in part because prescribers control the brand consumers use while also selling the lenses); Utah State Senator Curtis Bramble (NPRM Comment #576) (“The portability of a prescription is commonplace in almost every area where a prescription is needed, but often times it is hampered by the conflict that exists when a prescribing eye care provider has the opportunity to profit from the very product they're prescribing”); Rhode Island State Representative Brian Kennedy (NPRM Comment #3724) (citing “natural conflict of interest that exists in the industry”); Blumenthal Letter,

supra

note 17 (recognizing the “inherent conflict of interest” and noting that the FCLCA was made necessary by “the unique nature of the contact lens marketplace”).

Information Technology & Innovation Foundation (NPRM Comment #2848) (asserting that for those who would argue that more regulation is not the answer, the reason regulation is necessary in this instance is because the industry is already regulated, but in ways that give prescribers considerable power, since consumers cannot buy lenses without a prescription from their doctor).

Prescribers, however, were generally

critical of the Commission's proposal, with many calling it an unnecessary burden that would also interfere with the doctor-patient relationship by implying that prescribers violate the law.

Many remarked that prescribers take an oath of professional conduct and abide by an ethical responsibility to place their

patients' interests above their own.

Thus, many felt they were being unfairly maligned, and the proposal was tantamount to an attack on their integrity.

A few prescriber commenters supported the proposal, but these instances were rare.

E.g.,

Richter (NPRM Comment #2706) (ophthalmologist supporting the proposal); Simple Contacts (NPRM Comment #3479) (online prescriber and seller supporting proposal); Opternative (NPRM Comment #3785) (online prescriber supporting the proposal). Other prescriber commenters, such as the National Association of Optometrists and Opticians, supported aspects of the proposed acknowledgment, but not the Commission's actual proposal. (NPRM Comment #3851).

See, e.g.,

CLR Panel V Tr.,

supra

note 50, at 6 (statement of David Cockrell); Sorkin (WS Comment #602); Greenberg (WS Comment #628); Carlson (WS Comment #739); Johnson (WS Comment #755); Bryan (WS Comment #987); Martin (WS Comment #1168); Hill (WS Comment #1361); Armed Forces Optometric Society (NPRM Comment #2884); American Optometric Association (NPRM Comment #3830); Contact Lens Association of Ophthalmologists (NPRM Comment #4259).

See, e.g.,

Sclafani (WS Comment #631); Wright (WS Comment #743); Wardell (WS Comment #792); California Optometric Association (NPRM Comment #3845).

See, e.g.,

Dieckow (WS Comment #595) (“This is a witch hunt. It is quite parallel to the Spanish inquisition asking a village girl to prove she is not a witch”); Hallak (WS Comment #654) (“The proposed change to the contact lens release of information is ludicrous. The FTC should be ashamed for even consider [sic] it”); Owen (WS Comment #826) (“The FTC should recognize that we are not the enemy of consumers, but allies who are equally committed to protecting our patients' health and well-being”); Morabito (WS Comment #1135) (“This is a slap in the face of good people whose very purpose is to help people”); Holt (WS Comment #1375) (“having a patient sign a piece of paper that they are entitled to receive the contact lens prescription that they have already been given is just about the FTC and 1-800 trying to find a way to punish ODs for still being in existence”); Pirozzolo (WS Comment #1431) (“No other profession is required to have the patient sign an acknowledgment of receiving a prescription”).

See also, e.g.,

Rosenblatt (WS Comment #841); Smoke (WS Comment #1184); Vosseteig (WS Comment #1205); Siegel (WS Comment #1391).

2. Comments Concerning the Need for the Proposed Signed Acknowledgment Due to Non-Compliance

Several commenters asserted that the proposed signed-acknowledgment requirement is necessary because—even 14 years after creation of the Contact Lens Rule—prescribers often fail to release prescriptions automatically after a contact lens fitting.

A comment from the Attorneys General for 20 States,

for example, said they “are aware, from their enforcement efforts and collective experience, that not all patients receive their prescription in writing as a matter of course.”

Likewise, the CEO of a large contact lens seller, 1-800 CONTACTS, stated that the company performs “secret shops” of eye doctors and consistently finds that about 50% do not release prescriptions.

E.g.,

Institute for Liberty (NPRM Comment #2690); Citizen Outreach (NPRM Comment #3247); League of United Latin American Citizens (NPRM Comment #3326); Coalition for Contact Lens Consumer Choice (NPRM Comment #3718); Attorneys General for 20 States (NPRM Comment #3804); R Street Institute (NPRM Comment #3856); Warby Parker (NPRM Comment #3867); Consumers Union (NPRM Comment #3969).

Alabama, Delaware, Hawaii, Idaho, Illinois, Iowa, Maine, Maryland, Massachusetts, Minnesota, Montana, Nebraska, New Hampshire, New Mexico, New York, Oregon, Pennsylvania, Rhode Island, Vermont, and Virginia. Attorneys General for 20 States (NPRM Comment #3804).

Id.

CLR Panel III Tr.,

supra

note 75, at 11 (statements of John Graham).

Dozens of consumers also recounted personal stories in which they, or a family member, were either not provided with their prescriptions, experienced difficulty obtaining their prescriptions, or had to ask prescribers for them instead of receiving them automatically as required by law.

For example, one consumer said, “My experience has been that the majority of the time the contact lens prescription is not given out unless it's specifically requested and even then on some occasions the doctor's office is reluctant to release it,”

and another recounted, “I have fought with many a doctor and demanded a prescription and they still state that they will not do my eye exam unless I agree to purchase my contacts from them.”

Another commenter stated, “Each and every time I have gone to the eye doctor, I have had to ask for a copy of my prescription.”

Of those who had to ask for their prescriptions, several consumers complained that they felt uncomfortable making such a request or felt pressured into purchasing lenses from their prescriber and may have paid a higher price in consequence.

See, e.g.,

Keck (WS Comment #22); Mattox (WS Comment #28); Arthur (WS Comment #47); Barrett (WS Comment #259); Tyree (WS Comment #323); Fielding (WS Comment #376); Tennison (WS Comment #428); Lambrecht (WS Comment #448); Copley (WS Comment #515); Moses (WS Comment #875); Subowicz (WS Comment #926); Brotz (WS Comment #939); Bonner (WS Comment #982); Calk (WS Comment #984); Halston (WS Comment #1101); Gonzales (WS Comment #1437); Boue (NPRM Comment #1806); Collins (NPRM #1811); Herbst (NPRM Comment #1823); Tran (NPRM Comment #1829); Lozano-Adams (NPRM Comment #1831); Krainman (NPRM Comment #1847); Walker (NPRM Comment #1848); Zirbel (NPRM Comment #1849); Zeledon (NPRM Comment #1852); Diedrich (NPRM Comment #1856); Berry (NPRM Comment #1860); Montagnino (NPRM Comment #1866); Hochberg (NPRM Comment #1879); Bogner (NPRM Comment #1881); Rasczyk (NPRM Comment #1904); Fraga (NPRM Comment #1907); Vasquez (NPRM Comment #1917); Megraw (NPRM Comment #1933); Kasal (NPRM Comment #1937); Strobel (NPRM Comment #1940); Quinlog (NPRM #1963); Somerville (NPRM Comment #1966); Stanton (NPRM Comment #2001); Austin (NPRM Comment #2022); Cotten (NPRM Comment #2024); Bulmann (NPRM Comment #2045); Miller (NPRM Comment #2062); Robertson (NPRM Comment #2124); Capuano (NPRM Comment #2722); Martinez (NPRM Comment #2894); Woelfel (NPRM Comment #3131); Thomson (NPRM Comment #3421).

Rushton (NPRM Comment #2649).

Hamilton (NPRM Comment #1835).

Acton (NPRM Comment #2070).

E.g.,

Moses (WS Comment #875); Brotz (WS Comment #939); Calk (WS Comment #984); Fridley (WS Comment #988); Gonzales (WS Comment #1437); Vasquez (NPRM Comment #1917); Austin (NPRM Comment #2022); Ng (NPRM Comment #3289); James (NPRM Comment #4029).

Many commenters also said the acknowledgment is necessary because consumers are often unaware of their right to their prescription.

One commenter admitted, “I did not know this was a law. I have been charged $25 extra for receiving my contact lens prescriptions before.”

Another anecdotal, but perhaps telling, indicator of the lack of consumer awareness, was the surprising number of consumer commenters who asked the Commission to pass a Rule requiring prescribers to release their prescriptions.

One consumer, for instance, wrote, “I strongly urge the FTC to adopt the rule that will require eye doctors to provide patients with a copy of their prescription,”

and another proclaimed, “Would love to be free to purchase my contacts wherever I choose. I can't stand that my prescription is held hostage by my eyecare provider! Please help!”

In other words, these commenters, and many others, filed comments urging the Commission to grant them a right that they already have, and have had since 2004, but apparently are not aware of.

St. Louis (NPRM Comment #3531); 1-800 CONTACTS (NPRM Comment #3898).

See also, e.g.,

League of United Latin American Citizens (NPRM Comment #3326) (“Consumers who do not know their rights are being `trapped in the exam chair,' unaware that they can buy lenses elsewhere for lower prices.”); R Street Institute (NPRM Comment #3856) (“Consumers are insufficiently aware of their right to copies of their prescriptions, creating information asymmetries” between consumers and prescribers).

Monroe (NPRM Comment #4277).

See, e.g.,

Barrett (WS Comment #259); Pascucci (WS Comment #403); Biel (WS Comment #902); Randall (WS Comment #912); Rasczyk (WS Comment #913); Elliott (WS Comment #930); Slaydon (WS Comment #944); Palmer (WS Comment #956); Miller (WS Comment #1055); McBride (WS Comment #1088); Wilber (WS Comment #1162); Subach (WS Comment #1364); Krainman (NPRM Comment #1847); Boue (NPRM Comment #1806); Sattler (NPRM Comment #1808); Zeledon (NPRM Comment #1852); Vasquez (NPRM Comment #1917); Herron (NPRM Comment #1982); Tardif (NPRM Comment #2011); Burlingame (NPRM Comment #3115).

Ballou (NPRM Comment #3331).

Boue (NPRM Comment #1806).

a. Empirical Evidence of Compliance

In terms of empirical evidence, two commenters submitted new consumer surveys conducted by third-party polling firms, both of which reported that a substantial percentage of consumers do not receive prescriptions after a contact lens fitting as required by law.

One survey, submitted by 1-800 CONTACTS, reported that only 37% of patients automatically received a copy of their prescriptions after a contact lens fitting.

The other survey, submitted by Consumer Action, reported that just 44% of consumers received

prescriptions without having to ask for them.

According to the surveys, when consumers who did not receive prescriptions asked for them, prescribers typically complied.

100

But even counting those who asked for their prescriptions and subsequently received them, 24-31% of consumers—roughly 10-12 million patients a year—never received a copy of their prescriptions and were thus unable to comparison shop for lenses.

101

This data is generally consistent with previous consumer surveys discussed in the NPRM, such as the October 2015 Survey Sampling International survey, submitted by 1-800 CONTACTS, which found that 35% of consumers automatically received a prescription, 28% received one after asking for it, and 36% did not receive one at all.

102

Consumer Action (NPRM Comment #3721); 1-800 CONTACTS (NPRM Comment #3898).

1-800 CONTACTS (NPRM Comment #3898, Ex. A). Data is based on an online survey performed by the polling firm Survey Sampling International (“SSI”) on behalf of 1-800 CONTACTS. According to 1-800 CONTACTS, the survey was conducted during December 2016 and sampled 1000 contact lens wearers.

Consumer Action (NPRM Comment #3721). Data is based on a Caravan ORC International telephone survey of 2018 adults performed in January 2017.

See also

CLR Panel V Tr.,

supra

note 50, at 2 (statements of Linda Sherry).

100

See

Consumer Action (NPRM Comment #3721) (showing that 21% of total patients had to ask the prescriber for their prescription, and 20% of total patients received it upon request); 1-800 CONTACTS (NPRM Comment #3898, Ex. A) (showing that 36% of total patients had to ask for their prescription, and 31% of total patients received it immediately upon request, while 5% were told to call the office or return at a later time to receive a copy).

101

See

Consumer Action (NPRM Comment #3721); 1-800 CONTACTS (NPRM Comment #3898, Ex. A). The 10-12 million calculation is based on the estimate that there are currently 41 million contact lens wearers in the United States and that each patient receives one contact lens fitting a year. The Commission uses this estimate here since it used the same figures to assess the burden of the Rule. In actuality, it is probably less, since some contact lens wearers go longer than twelve months between fittings.

102

NPRM, 81 FR 88531-32. Data was based on a SSI online survey of 500 contact lens wearers in 2015. As noted in the NPRM, the manner in which the questions were phrased in this particular survey raised some Commission concerns, since some of them were leading, lacked an “I don't know” option, and used a term—“hard copy”—which not all patients may understand.

Id.

at 88531 n.73.

The Consumer Action survey also found that 60% of consumers responded “no” when asked, “Are you aware that under federal law, a doctor or exam provider is required to automatically provide their patient with a copy of their prescription after they get their contact lens exam?”

103

1-800 CONTACTS cited a previously submitted survey, which found that 46% of contact lens wearers were unaware that they had a right to receive a “hard copy” of their prescription.

104

103

Consumer Action (NPRM Comment #3721). Data is based on a Caravan ORC International telephone survey of 2018 adults performed in January 2017. Thirty-eight percent said “yes,” and 2% responded “I don't know” or refused to answer. The Commission has some concerns that the question was leading, but also notes that it is possible that the 60%-unaware result actually underestimates the number of consumers unaware of their rights. This is due to social desirability bias, the tendency of survey respondents to answer questions in a manner that will be viewed favorably by others. As noted in the NPRM, respondents may be reluctant to admit that they are unaware of their rights under the law. NPRM, 81 FR at 88532.

104

1-800 CONTACTS (NPRM Comment #3898). Data is based on a SSI online survey of 500 contact lens wearers in 2015. NPRM, 81 FR at 88532.

Various prescriber commenters criticized the polling evidence as “unreliable,”

105

and said the aforementioned surveys are tainted by the interests of their sponsors.

106

According to two prescriber associations, evidence submitted by 1-800 CONTACTS should not be deemed reliable because the submitter is a “stakeholder” rather than a disinterested party and has a history of aggressively seeking competitive advantages.

107

The American Optometric Association (“AOA”) further noted that Consumer Action—a non-profit consumer advocacy organization—has received corporate financial support from, among others, 1-800 CONTACTS.

108

105

CooperVision, Inc. (NPRM Comment #3841).

See also

Coalition for Patient Vision Care Safety (NPRM Comment #3883) (“the quality of evidence is not sufficient to support the need for this requirement”).

106

American Academy of Ophthalmology (WS Comment #2971) (“It is our opinion that evidence should not include industry-sponsored surveys, seeking a specific result, to propel a specific narrative for their benefit.”); American Optometric Association (WS Comment #3303) (“We question the legitimacy of the information on alleged non-compliance that 1-800 CONTACTS has provided to the Commission.”).

107

American Academy of Ophthalmology (WS Comment #2971); American Optometric Association (WS Comment #3303). In particular, the AOA argues that surveys conducted on behalf of 1-800 CONTACTS are not credible because: (1) The FTC has previously sued 1-800 CONTACTS for anti-competitive practices against other contact lens retailers (

see https://www.ftc.gov/enforcement/cases-proceedings/141-0200/1-800-contacts-inc-matter

); (2) 1-800 CONTACTS supports online vision examinations and thus might have a financial interest in discrediting brick-and-mortar optometrists; and (3) the Arizona Board of Optometry concluded that many complaints about prescriber non-compliance that 1-800 CONTACTS filed with the board were unfounded.

See also

Bhadra (WS Comment #801) (“I find it disingenuous that these online retailers have flooded the public with fake news that ODs are not giving patients their contact lens prescriptions.”).

108

American Optometric Association (WS Comment #3303).

The AOA also asserted that consumer surveys may be unreliable because they are based on patient-reported data and—as the Commission has previously recognized—patients might not always understand that they are entitled to a copy of their prescription only after their contact lens fitting has been fully completed.

109

To rebut these surveys and demonstrate that prescribers are complying, the AOA submitted a survey of fifty-seven “high-volume optometrists,” in which 93% said “yes” when asked, “Do you follow Federal law and provide patients with a copy of their contact lens prescription upon completion of a contact lens fitting?”

110

109

Id. See also

CooperVision, Inc. (NPRM Comment #3841) (stating Commission overstates evidence of noncompliance by not distinguishing between initial visits to prescribers and subsequent contact lens fittings in which the prescription is finalized); NPRM, 81 FR at 88530-31 (noting that consumers are not always aware of when they are entitled to their prescriptions).

110

American Optometric Association (WS Comment #3303, App. B). This survey appears to have been conducted by the AOA itself rather than an outside polling firm. It is not clear from the AOA's submission how the fifty-seven optometrists were selected for the survey, what it means to be a “high volume” optometrist, or why high volume optometrists were chosen.

As the Commission acknowledged in its NPRM, all surveys have limitations with respect to methodology and evidence, and, in this instance, the Commission does not treat any one survey as definitive. Patients may sometimes misremember details of a particular encounter with a prescriber, and prescribers may be mistaken about the particulars of a given clinical encounter or about the frequency with which they do or do not release prescriptions. For the most part, the submitted surveys do not include independent objective tests of patient or prescriber recollections. In addition, survey responses may be sensitive to the ways in which questions are framed.

Despite what some commenters recommend, however, the Commission does not dismiss survey evidence based solely on the source of its submission. While the Commission is cognizant of the interests of submitting parties, the Commission examines the underlying survey data and methodology to gauge a survey's usefulness. In the case of the consumer surveys, which were conducted by established third-party polling firms, the submitters provided the Commission with the underlying questions, responses, and statistical data, as well as details about survey methodology. Based on its review of the submitted material, the Commission finds that the two new consumer surveys represent an improvement over previously submitted consumer surveys. In particular, the new surveys include an option for respondents to acknowledge that they do not recall whether they received their prescriptions and use the term “paper copy” rather than “hard copy,” a term the Commission has previously noted some patients may not understand. The number of consumers polled is also larger than some previous surveys. The

Commission further recognizes that the new surveys are generally consistent with the findings of previously-submitted surveys, and that multiple surveys conducted by different sources at different times with similar results bolster the credibility of each individual survey. The Commission also has not received any consumer-survey data rebutting these findings or indicating that consumers consistently receive their prescriptions in satisfactory numbers. The Commission therefore accords the overall submitted consumer-survey data significant weight.

In contrast, the Commission finds the AOA-submitted survey of prescribers less useful as a tool to assess compliance with the prescription-release requirement. The Commission has several concerns. Besides concerns about the small sample size (fifty-seven) and lack of detail as to how prescriber respondents were recruited, the Commission notes that the way the question is phrased

111

allows prescribers to truthfully answer that they provide patients with a copy of their prescription even if they do not do so for

every

patient, and even if they only do so when the patient requests one. Moreover, the wording of the survey question makes it highly unlikely a prescriber would admit to not releasing prescriptions. As noted (in a different context) in the NPRM, asking a respondent if he or she is aware of their rights or obligations under the law can skew responses, since respondents may be unwilling to admit they are ignorant of the law or violate it.

112

In this instance, prescribers also have a clear incentive to say they follow Federal law even if they do not (whereas consumers do not have a clear incentive to say that prescribers are not providing them with their prescriptions). Based on the wording and framing of the question in the AOA survey, the Commission is surprised that even 7% of prescribers answered that they do not provide patients with their prescriptions, a result that, if extrapolated to the population of prescribers, would still mean that every year more than 2.7 million consumers are denied their prescriptions—and their ability to comparison-shop for more affordable contact lenses—in violation of the law.

113

111

“Do you follow Federal law and provide patients with a copy of their contact lens prescription upon completion of a contact lens fitting?”

112

See

NPRM, 81 FR at 88532.

113

This calculation is based on estimates that there are currently 41 million contact lens wearers in the United States and that each patient gets one contact lens fitting a year.

See supra

note 101.

Apart from the three surveys, no other commenter submitted empirical evidence of automatic-release compliance or consumer awareness.

114

Several commenters, nonetheless, strongly opined that the Commission lacks “compelling evidence” that the signed acknowledgment is needed

115

and said they are “unaware” of significant compliance problems among eye-care professionals.

116

Numerous prescribers also declared that, personally, they consistently release prescriptions to patients after each contact lens fitting, and believe their colleagues do the same.

117

Several prescribers were also firm in their belief that patients are fully aware they have a right to their prescription,

118

with some noting that advertising and marketing from third-party sellers help remind patients of their rights.

119

Many prescribers thus proclaimed that the signed- acknowledgment proposal was a waste of resources, both for prescribers and the Commission,

120

and called it a “solution in search of a problem.”

121

Other commenters said that even if it is true that a small number of prescribers do not comply with the automatic-release requirement, the proposed acknowledgment requirement would be, in effect, “punishing the masses for the sins of the few.”

122

114

At the CLR Workshop, some audience members commented that in their state, the prescription release rate was 100%. Commission staff asked that this data be provided, but it never was.

See

CLR Panel V Tr.,

supra

note 50, at 23. Another commenter, Lens.com, commented that more than half of its customers “report that optometrists still do not provide prescriptions as required by law.” (NPRM Comment #2358). However, Lens.com could not provide the Commission with information about how it surveyed its customers and exactly what consumers reported, so the Commission has not relied on this evidence.

115

McGrew (WS Comment #713).

See also, e.g.,

American Society of Cataract and Refractive Surgery (WS Comment #3142); Davies (WS Comment #3307); Utah Ophthalmology Society (NPRM Comment #2586); American Academy of Ophthalmology (NPRM Comment #3657); CooperVision, Inc. (NPRM Comment #3841).

116

See, e.g.,

Cooperman (NPRM Comment #2382); American Academy of Ophthalmology (NPRM Comment #3657); American Society of Cataract and Refractive Surgery (NPRM Comment #3820); American Optometric Association (NPRM Comment #3830); Wisconsin Academy of Ophthalmology (NPRM Comment #4152); Kentucky Academy of Eye Physicians and Surgeons (NPRM Comment #4276).

117

E.g.,

Palys (WS Comment #560); Widmann (WS Comment #618); Nixon (WS Comment #687); Bausback (WS Comment #708); Lo (WS Comment #856); Hanian (WS Comment #1196); Carkner (WS Comment #1287); Myers (WS Comment #1322); Leung (WS Comment #1600); Randle (WS Comment #2171); Stamm (WS Comment #2512); Swan (WS Comment #2843); Olson (WS Comment #2970); Wisniewski (NPRM Comment #1769). Over sixty prescribers also submitted identical, or nearly identical, comments which included the following statement, “First, I would like to make clear that I comply with the requirements of the Fairness to Contact Lens Consumers Act (FCLCA) and the corresponding Contact Lens Rule by providing copies of contact lens prescriptions to contact lens wearing patients at the end of the contact lens fitting process.”

E.g.,

Shepherd (WS Comment #483); Alexander (WS Comment #468); Morton (WS Comment #488); Skrdla (WS Comment 492); Smith (WS Comment #493); Hertneky (WS Comment #494); Eklund (WS Comment #502); Buchanan (WS Comment #520); Borden (WS Comment #865); Bryan (WS Comment #987); (Redmond (WS Comment #989).

118

E.g.,

Lonsk (WS Comment #596); Friederich (WS Comment #614); Highsmith (WS Comment #690); Bedsole (WS Comment #1024); Phillips (WS Comment #1151); Sumner (WS Comment #1332); Hill (NPRM Comment #3561).

119

California Academy of Eye Physicians and Surgeons (NPRM #4269) (online retailers are “not shy” about letting consumers know they have a right to their prescriptions).

See also

Dinh (WS Comment #1653); Ulc (WS Comment #2347).

120

See, e.g.,

To (WS Comment #597); DeKinder (WS Comment #625); Bausback (WS Comment #708).

121

E.g.,

Kaminski (WS Comment #607); Bank (WS Comment #653); Melman (WS Comment #667); Nixon (WS Comment #687); Hamilton (WS Comment #781); Martin (WS Comment #1168); McMahon (WS Comment #1868); Randle (WS Comment #2171); Jones (WS Comment #3079); Cervantes (WS Comment #3125); Khong (WS Comment #3435).

See also, e.g.,

Wesley (WS Comment #835); Kline (WS Comment #852); Holcomb (WS Comment #872); Edwards (WS Comment #884); Boyce (WS Comment #1466); Woodward (NPRM Comment #273); McLaughlin (NPRM #1365); Blankenship (NPRM Comment #2117); Armed Forces Optometric Society (NPRM Comment #2884); Sonsino (NPRM Comment #3783); Sterna (NPRM Comment #3892).

Prescriber assertions about overwhelming compliance with the automatic-release requirement are undermined somewhat by the large number of prescriber commenters who misstated the Rule and said that they “offer” prescriptions to their patients or provide them “when requested,” rather than provide them automatically after each fitting.

123

Ten state ophthalmology associations commented that the signed acknowledgment is unnecessary because eye doctors in their states are providing patients with their prescriptions “

when requested

in full compliance with the Contact Lens Rule”

124

(emphasis added). Both the

Act and the Rule specifically require that a prescription be provided to each patient “whether or not requested by the patient,” and the Commission does not have authority to amend the statute or disregard this obligation.

123

See, e.g.,

Moore (WS Comment #544); Heiby (WS Comment #694); Larson (WS Comment #716); Krisciunas (WS Comment #1085); Pebley (WS Comment #1261); Horibe (WS Comment #3242); Mitsoglou (NPRM Comment #480); Frieman (NPRM Comment #2589); Cooper (NPRM Comment #2673).

124

Utah Ophthalmology Society (NPRM Comment #2586); South Dakota Academy of Ophthalmology (NPRM Comment #2588); Michigan Society of Eye Physicians and Surgeons (NPRM Comment #4165); Florida Society of Ophthalmology (NPRM Comment #4197); Iowa Academy of Ophthalmology (NPRM #4199); Oklahoma Academy of Ophthalmology (NPRM Comment #4204); Pennsylvania Academy of Ophthalmology

(NPRM Comment #4214); Indiana Academy of Ophthalmology (NPRM Comment #4233); Massachusetts Society of Eye Physicians and Surgeons (NPRM Comment #4270); Kentucky Academy of Eye Physicians and Surgeons (NPRM Comment #4276).

b. Verifications as Evidence of Lack of Prescription Release

Many prescribers also contend that the Commission erred in its NPRM finding that the large number of contact lens sales conducted via verifications is evidence of lack of prescription release. According to these commenters, the number of verifications does not reflect lack of prescription release since some consumers may lose their copies and some online sellers promote the ease (for the consumer) of the verification method.

125

In contrast, some sellers stated that from a business standpoint, they prefer and encourage patients to present prescriptions rather than rely on verification, since it is faster for the consumer and less costly for the seller.

126

1-800 CONTACTS, for instance, promotes presentation at checkout as a way for consumers to get their lenses more quickly, and has run promotional campaigns offering consumers a discount on lens orders if they would send in a copy of their prescription.

127

Additionally, several commenters, including some prescribers, agreed that a signed acknowledgment would likely reduce the percentage of sales via verification, indicating that some percentage of consumers are not receiving their prescriptions at their contact lens fitting.

128

Nevertheless, the Commission recognizes that it can be more cumbersome for a consumer to locate and upload a prescription than to simply type in the name of their prescriber and their prescription information—which they can obtain from their contact lens boxes—and thus some consumers may opt for verification even though they did receive a copy of their prescription. The Commission is also aware that some online contact lens sellers do not currently have a mechanism for patients to present their actual prescriptions, and rely solely on verification. Thus, while the Commission will still consider the large percentage of third-party contact lens sales conducted via verification

129

as suggestive of prescriber failure to release prescriptions, the Commission will accord it less weight than it did in the NPRM.

125

American Optometric Association (NPRM Comment #3830) (sellers promote verification as an easy way to get refills).

126

See

FTC, The Contact Lens Rule and the Evolving Contact Lens Marketplace, Panel IV: Examining the Verification Process Tr. at 6-7 (Mar. 7, 2018),

https://www.ftc.gov/system/files/documents/public_events/1285493/panel_iv_examining_the_verification_process.pdf

[hereinafter CLR Panel IV Tr.] (statement of Jennifer Sommer);

id.

at 6-7, 22 (statement of Cindy Williams).

127

Id.

at 6-7.

128

See, e.g.,

CLR Panel V Tr.,

supra

note 50, at 9 (statement of David Cockrell that it would absolutely reduce the number of verifications, but would not eliminate them, since patients often lose their prescription copies); National Association of Optometrists and Opticians (WS Comment #3208); Costco Wholesale Corporation (NPRM Comment #4281).

129

NPRM, 81 FR at 88531 (estimated at roughly three-quarters of third-party sales).

c. The Dearth of Consumer Complaints to the FTC as Evidence of Prescriber Compliance

Several commenters made the point that, in proportion to the total number of contact lens users in the United States, there have been relatively few consumers—only a few hundred—who actually filed complaints with the Commission about prescribers' failing to release prescriptions, and since 2007, only fifty-five prescribers have received FTC warning letters about possible non-compliance.

130

According to these commenters—the American Optometric Association, in particular—the small percentage of complaining consumers and Commission warning letters indicates that prescribers, for the most part, are complying with the automatic prescription-release requirement.

131

130

American Optometric Association (WS Comment #3303); (American Optometric Association, NPRM Comment #3830). According to AOA's analysis of consumer complaints filed with the Commission, from 2012-2016, there have been only 309 complaints relating to prescriber failure to release prescriptions, and only .0003% of the 41 million contact lens wearers, approximately 123 patients, filed what the AOA regarded as potentially valid complaints about a prescriber's failure to release a prescription.

See also, e.g.,

Stubinski (WS Comment #1701); Fritsch (WS Comment #2543); Higley (WS Comment #2857); Tran (WS Comment #3106).

131

American Optometric Association (WS Comment #3303).

See also

Contact Lens Rule, 69 FR at 40492 (discussing a commenter proposal to allow prescribers to not release the prescription or release it “for informational purposes only” if the patient has purchased a full year's supply of contact lenses at the time of the examination, and rejecting it because “such an exception would be contrary to the Act's express requirement that consumers receive a copy of their prescription at the completion of a contact lens fitting”).

3. Comments Concerning Whether a Proposed Signed Acknowledgment Is Needed for Better Enforcement and Auditing of the Rule

In its December 2016 NPRM, the Commission noted that a signed acknowledgment would increase the Commission's ability to assess and verify compliance with the Rule.

144

Several commenters agreed, suggesting that the signed-acknowledgment proposal is necessary because the prescription-release requirement is currently difficult or impossible to enforce.

145

According to one commenter, prescribers have little incentive to comply with automatic release because compliance could result in lost sales, and absent some evidentiary record, an FTC enforcement action is extremely unlikely.

146

Another commenter noted that while the Commission has sent warning letters in response to complaints about lack of prescription release, the Commission has yet to bring an enforcement action or seek fines against a prescriber for failure to release contact lens prescriptions.

147

According to some

commenters, the Commission needs an auditable process in order to enforce the Rule and the FCLCA.

148

To demonstrate how the current Rule lacks teeth, one commenter, 1-800 CONTACTS, commented that it conducted a follow-up “secret shop” of twenty-one of the forty-five prescribers who received FTC warning letters in 2016, and found that even after receiving these warnings, eighteen still failed to automatically release a prescription after completion of a contact lens fitting.

149

Some commenters also suggested that a signed record would actually help prescribers by giving them a way to prove that they provided the prescription, and thus prevent consumers from incorrectly alleging that a prescriber violated the law.

150

144

NPRM, 81 FR at 88532.

145

See, e.g.,

Information Technology and Innovation Foundation (NPRM Comment #2848); Arizona State Rep. Heather Carter (NPRM Comment #3193); Semelsberger (NPRM Comment #3856); 1-800 CONTACTS (NPRM Comment #3898).

146

Warby Parker (NPRM Comment #3867).

147

1-800 CONTACTS (NPRM Comment #3898). The Commission has brought one case against a prescriber for failure to release eyeglass prescriptions in violation of the Eyeglass Rule, and

resolved the suit with a consent decree and $10,000 penalty.

United States

Doctors Eyecare Ctr. Inc.,

No. 96-cv-012224-D (N.D. Tex. June 25, 1996). It is also worth noting that warning letters are typically sent in response to consumer complaints, and, as noted

supra,

for a number of reasons, consumers are unlikely to complain to the Commission when they do not receive their prescriptions.

148

See

Information Technology and Innovation Foundation (NPRM Comment #2848); 1-800 CONTACTS (NPRM Comment #3898); Costco Wholesale Corporation (NPRM Comment #4281).

See also

CLR Panel III Tr.,

supra

note 75, at 12 (“there needs to be a mechanism for enforcement”).

149

Baker Analysis,

supra

note 133, at 10.

150

CLR Panel V Tr.,

supra

note 50, at 27 (statements of Linda Sherry); Consumers Union (NPRM Comment #3969).

Other commenters, however, suggested that the Commission could do a better job of enforcing the current release requirement instead of adding a signed-acknowledgment requirement.

151

One commenter suggested that instead of the signed acknowledgment, the Commission should conduct its own “secret shops” of prescriber offices and fine those who fail to release prescriptions.

152

151

See e.g.,

Bernard (WS Comment #588); Click (WS Comment #876).

152

Pearl (WS Comment #824).

Several prescribers also suggested that the signed-acknowledgment requirement itself would be difficult to enforce

153

or that it was unlikely that prescribers who do not currently comply with prescription release would comply with the signed-acknowledgment requirement.

154

Similarly, some prescribers doubted whether consumers would read the signed-acknowledgment document and thus questioned its use for education purposes.

155

153

Missouri Optometric Association (NPRM Comment #1208).

154

See, e.g.,

Pearl (WS Comment #824); Koch (WS Comment #855); Holcomb (WS Comment #872); Edwards (WS Comment #884); Alwes (WS Comment #998); Jones (WS Comment #2778); Contact Lens Association of Ophthalmologists (NPRM Comment #4259); California Academy of Eye Physicians and Surgeons (NPRM Comment #4269).

155

CLR Panel V Tr.,

supra

note 50, at 9 (statements of Zachary McCarty); Gasparini (WS Comment #825); Schweiger (WS Comment #993).

4. Comments About the Burden of the Signed-Acknowledgment Proposal

A significant number of commenters felt that the Commission underestimated the burden that the signed-acknowledgment requirement would impose on prescribers, and said the actual burden would be much more “substantial.”

156

According to commenters, the Commission's estimate

157

did not fully recognize the time it would take to train office staff, answer consumers' questions, and create, produce and store the acknowledgment form for three years.

158

The National Association of Optometrists and Opticians (“NAOO”) predicted the acknowledgment requirement would add five minutes to each transaction “because of the need to explain the reason for the signature to the patient,”

159

and stressed that “storage of the myriad pieces of paper is not a small burden.”

160

156

American Academy of Ophthalmology (NPRM Comment #3657).

See also, e.g.,

American Society of Cataract and Refractive Surgery (NPRM Comment #3820) (“will have significant cost implications”); CLR Panel V Tr.,

supra

note 50, at 6 (statement of David Cockrell) (“I think it creates a very significant burden.”); Rohler (NPRM Comment #377); Stott (NPRM Comment #687).

157

The Commission's estimate was forty-one million minutes per year, based on an estimate of 41 million contact lens wearers and one minute to present each patient with the form, obtain a signature, and scan or store the record. NPRM, 81 FR at 88557. The Commission stated that in all likelihood, the burden would actually be far less, since the Commission did not credit the reduction in verification burden that would likely occur once additional consumers were in possession of their prescriptions. Additionally, not all contact lens wearers obtain eye exams every year. In 2017, for instance, there were approximately 34 million contact lens eye exams in the U.S. CLR Panel I Tr.,

supra

note 72, at 5 (statements of Steve Kodey). If the number of actual exams had been used to calculate the burden, this would have reduced the estimated burden to 34 million minutes.

See also

1-800 CONTACTS (NPRM Comment #3898) (estimating that the average exam frequency for contact lens patients is 15 months, citing

https://www.clspectrum.com/issues/2016/november-2016/four-strategies-for-practice-growth

); CLR Panel IV Tr.,

supra

note 126, at 3 (statements of Cindy Williams) (stating that evidence indicates the majority of contact lens wearers get an exam once every 12-16 months).

158

See, e.g.,

National Association of Optometrists and Opticians (WS Comment #3208); Toepfer (NPRM Comment #652); Slusser (NPRM Comment #149); Armed Forces Optometric Society (NPRM Comment #2884); American Society of Cataract and Refractive Surgery (NPRM #3820); American Optometric Association (NPRM Comment #3830); California Optometric Association (NPRM Comment #3845).

159

National Association of Optometrists and Opticians (NPRM Comment #3851).

160

Id.

Several prescribers predicted they would incur thousands of dollars in staff time, printing, and electronic records costs, although most did not provide a detailed basis for their estimates.

161

Some commenters also questioned why the Commission was imposing a paper-storage requirement when so many physicians—at the urging of health authorities—are moving toward electronic records, and spending significant amounts of money to make that transition.

162

Others said they already make the prescription available electronically via patient portals, so this would just generate unnecessary paper waste.

163

161

See, e.g.,

Wright (WS Comment #743); Wesley (WS Comment #835); Norman (WS Comment #1285); Paulsen (WS Comment #1335); Dice (WS Comment #1585); Loomis (WS Comment #3300); California Optometric Association (NPRM #3845).

162

E.g.,

Akers (WS Comment #577); Rule (WS Comment #775); Schindler (WS Comment #1160); Ball (WS Comment #2861).

163

E.g.,

Nau (WS Comment #683); Carvell (WS Comment #1021).

See also

Chuang (WS Comment #864).

A number of commenters predicted that the burden would force prescribers to raise patient fees to cover increased administrative costs.

164

Some also felt it was unfair that prescribers, who currently shoulder a larger financial share than sellers of the costs imposed by the Rule, would now be responsible for even more.

165

Some commenters said that by imposing this new burden, it would be harder for prescribers to compete with third-party sellers, and thus the proposal could hinder competition rather than foster it, and some prescribers might have to stop selling lenses.

166

Many prescribers also criticized the proposed signed acknowledgment because they said it would not improve patient health or address what they believe are questionable practices by third-party retailers that put patients' eye health at risk.

167

Many of these commenters

suggested that the Commission re-approach the Rule review with patient safety as the number one priority.

168

164

See, e.g.,

Mitchell (WS Comment #238); Anders (WS Comment #479); Bjork (WS Comment #591); Giusto (WS Comment #740); Reed (WS Comment #749); Smith (WS Comment #1245); Paulsen (WS Comment #1335); Hamilton (WS Comment #2017); Joe (WS Comment #2340); Webster (WS Comment #2515); Ritter (WS Comment #2888); American Optometric Association (NPRM Comment #3830).

165

See

Utah Ophthalmology Society (NPRM Comment #2586); American Optometric Association (NPRM Comment #3830).

166

See, e.g.,

Koch (WS Comment #855); Willingham (WS Comment #858); Heltsley (WS Comment #1028); American Optometric Association (NPRM Comment #3830); Teed (NPRM Comment #4232).

167

See, e.g.,

Wright (WS Comment #743) (“Instead of going after doctors that take an oath, are held to high standards and depend on excellent patient care reputation to retain patients, the FTC should be going after the unscrupulous contact lens sellers that put profits far ahead of patient eye

health concerns”); Satjawatcharaphong (WS Comment #1030) (“There is no justification for targeting eye doctors . . . while the Commission allows retailers who blatantly violate the law to operate unchecked.”); Vosseteig (WS Comment #1205) (“These proposed changes are NOT in the best interests in the patient, and are attacking optometry, instead of the retailers who consistently and constantly abuse the unenforced rules already in place. Do not target eye doctors! New paperwork and document storage requirements are NOT going to protect the patient, but will only add cost and time to an already broken health system.”).

See also

McLoughlin (WS Comment #1311); Utah Ophthalmology Society (NPRM Comment #2586); American Society of Cataract and Refractive Surgery (NPRM Comment #3820); California Optometric Association (NPRM Comment #3845); Simsarian (NPRM Comment #3902); Foster (NPRM Comment #3981); Nakano (NPRM Comment #4353).

168

Utah Ophthalmology Society (NPRM Comment #2586).

A few commenters also said the new requirement would add a burden to consumers, since they would not want to sign another form

169

or might have to return to their prescribers' offices to sign the acknowledgment receipt, whereas currently some contact lens fittings are finalized remotely (via phone, text, or email) after the patient takes home trial lenses for a few days.

170

Other commenters contested this assessment, stating that the percentage of consumers who complete their contact lens fitting remotely is small (by one estimate just 9%), and that prescribers who complete a fitting remotely could satisfy the signed-acknowledgment requirement by retaining proof that they transmitted the actual prescription to the patient.

171

169

Kampa (NPRM Comment #3042); Mecham (NPRM Comment #3419); Dang (NPRM Comment #3508); Warner (NPRM Comment #3533).

170

Fortier (NPRM Comment #363); Dingley (NPRM Comment #342); Wisconsin Academy of Ophthalmology (NPRM Comment #4152).

171

1-800 CONTACTS (NPRM Comment #3898, Ex. B). Results are based on an online panel study of 753 optometrists between December 12, 2016 and January 4, 2017.

See also

CLR Panel V Tr.,

supra

note 50, at 11 (statements of David Cockrell that he would be “really surprised” if less than 80%-90% of contact lens fittings are completed in person); Simple Contacts (NPRM Comment #3479) (requirement could be satisfied remotely with “little additional effort”); Opternative (NPRM Comment #3785) (“they can be sent and completed either electronically or via hardcopy in the office at the end of a fitting and added to a patient's existing medical record, which most states require to be kept for at least three years”).

On the issue of burden, the AOA submitted a third-party survey and analysis conducted by Avalon Health Economics (the “Avalon Report”), which reported that optometrists expect it will take 3.12 minutes to explain to each patient the purpose of the signed acknowledgment, 3.41 minutes to answer questions from patients who seek more information, and 13.31 minutes of training to teach staff how to correctly address patient concerns about the acknowledgment (although only 44% of optometrists said additional training would be necessary).

172

According to the AOA, the analysis shows that the cost of implementing the signed-acknowledgment proposal could be as high as $18,795 for a practice with one optometrist, and as high as $49,913 for a practice with three optometrists.

173

Approximately 85% of this estimated burden, however, came not from training, explaining, or answering questions about the signed acknowledgment, but rather from the general cost of “total administrative time associated with adhering to the rules, regulations and policies regarding the operation of your practice.”

174

In other words, the bulk of the burden derived not from the new signed-acknowledgment requirement, but from adhering to rules and regulations in general, including existing rules and regulations.

175

172

American Optometric Association (NPRM Comment #3830). According to the AOA, the survey was disseminated to approximately 1000 optometrists, of whom 130 responded. The survey asked them to describe how much time it takes them to introduce a new patient engagement process and conduct periodic assessments of such a process, and how much time they anticipate they and their staff would spend answering questions and explaining the purpose of the signed acknowledgment to patients. It also asked them for the “total administrative time associated with adhering to the rules, regulations and policies.”

173

American Optometric Association (NPRM Comment #3830).

174

Id.

175

The AOA burden estimate was also cited by numerous other commenters as evidence that the acknowledgment proposal would be extremely burdensome for prescribers, and disproportionate to the harm caused by prescriber failure to release prescriptions.

See, e.g.,

Letter from Seven Representatives,

supra

note 131; Letter from Fifty-Four Representatives,

supra

note 131; Boozman Letter,

supra

note 131; Letter from Fifty-Eight Representatives,

supra

note 131.

After its own review of the Avalon Report, the Commission doubts its reliability and usefulness. Of greatest concern is that the bulk of the estimated burden is derived not from the signed-acknowledgment proposal, but rather from responses to the survey's open-ended question regarding total indirect costs of adhering to government regulations. As noted, these encompass regulations that are already in place and already taking prescriber adherence time, but may be unrelated in any way to the Commission's proposal. Furthermore, the survey also asked prescribers to predict whether patients would have questions, rather than surveying patients themselves as to whether they would have questions. Moreover, the relatively small sample of optometrists who responded to the survey (130) knew the sponsor and purpose of the survey beforehand. In fact, the AOA had urged its members to comment on the NPRM and provided them with a sample letter declaring that the Commission's NPRM burden estimate did not sufficiently account for “ongoing staff training” and the “additional step in the patient engagement process.”

176

Thus, Avalon survey respondents may have been unduly influenced to inflate the burden of complying with existing regulations and the proposed new one. Based on these and other concerns,

177

the Commission cannot accord significant weight to many of the survey's findings or cost estimates, although it will still consider whether to include training time in its determination of the overall burden and need for the proposal.

176

E.g,

Mass Mail Campaign (NPRM Comment #283) (1,415 submissions).

See also, e.g.,

Shaw (NPRM Comment #314); Schwartz (NPRM Comment #321); Yin (NPRM Comment #326); Singh (NPRM Comment #340); Stahl (NPRM Comment #355); Moore (NPRM Comment #365); Brozzo (NPRM Comment #366); Rohler (NPRM Comment #377); Woo (NPRM Comment #400); Heeg (NPRM Comment #407); Le (NPRM Comment #416); Lemke (NPRM Comment #441); Durham (NPRM Comment #473); Mueller (NPRM Comment #513); Williams (NPRM Comment #411); Kirsch (NPRM Comment #495); Bond (NPRM Comment #497); Palys (NPRM Comment #538); Kanevsky (NPRM Comment #555); Nordwall (NPRM Comment #576); Johnson (NPRM Comment #613); Bate (NPRM Comment #647); Toepfer (NPRM Comment #652); Korley (NPRM Comment #653); Wegener (NPRM Comment #665); Melman (NPRM Comment #676); Williams (NPRM Comment #703); Ballard (NPRM Comment #756); Cass (NPRM Comment #757).

177

The analysis did not account for the fact that 16% of optometrists do not believe consumers will have additional questions about the signed acknowledgment. The survey also does not supply information on the mean and variance of the open-ended question regarding time. If any respondents significantly overestimated the time spent adhering to rules, those figures would distort the overall average, particularly since only 130 optometrists participated.

In marked contrast to the views of prescribers, other commenters called the Commission's signed-acknowledgment proposal a measured approach that would be easy to administer and impose a relatively minor burden.

178

According to the consumer advocacy organization Consumers Union, “The burden of having copies of the one-page form available in the eye doctor's office, having each patient sign a copy of the form when receiving the prescription, and keeping that copy in a file for three years, is minimal and entirely

manageable, and will enable more effective enforcement of the rule while also making it easier for eye doctors to show compliance.”

179

Likewise, other commenters stated that such a requirement should be easy to administer, particularly if prescribers use an electronic device to present the acknowledgment and record the signature electronically.

180

Other commenters felt that the signed acknowledgment would be similar to the HIPAA acknowledgment that prescribers are already obtaining from each patient, and thus would not cause an excessive burden.”

181

178

See e.g.,

Information Technology & Innovation Foundation (NPRM Comment #2848). Citizen Outreach (NPRM Comment #3247); Thompson (NPRM Comment #3302); Searrles (NPRM Comment #3304); Simple Contacts (NPRM Comment #3479); Coalition for Contact Lens Consumer Choice (NPRM Comment #3718); Opternative (NPRM Comment #3785); Attorneys General of 20 States (NPRM Comment #3804); Consumers Union (NPRM #3969); National Taxpayers Union (NPRM #4262).

179

Consumers Union (NPRM Comment #3969).

See also

Mouzon (NPRM Comment #2121) (“This requirement would add only a minimal paperwork burden on optometrists, but it could have a major impact on protecting the rights of consumers. It will also help keep prices low, which is important to my family”); Truman (NPRM Comment #3285) (“This isn't too much work to ask of optometrists and it will make sure everyone will be able to make that choice [of where to buy contacts].”)

180

Information Technology & Innovation Foundation (NPRM Comment #2848); Thompson (NPRM Comment #3302); Simple Contacts (NPRM Comment #3479).

181

Costco Wholesale Corporation (NPRM Comment #4281); Richter (NPRM Comment #2706).

Some commenters questioned prescribers' estimates for how long it would take to explain the signed acknowledgment to each consumer.

182

1-800 CONTACTS submitted a third-party survey that reported that on average, it took consumers twelve seconds to read the proposed two-sentence acknowledgment statement, 90% of those surveyed understood the purpose of the signed acknowledgment, and only 4% had any questions or comments they would ask about it.

183

182

1-800 CONTACTS (WS Comment #3207); CLR Panel V Tr.,

supra

note 50, at 7 (statement of Linda Sherry that she does not believe that consumers would have a lot of questions about signed-acknowledgment statement).

See also

National Association of Optometrists and Opticians (NPRM Comment #3851) (estimating it might add 5 minutes or more per transaction, but also stating, “Doctor's offices typically do a quick explanation of the form(s) to be signed and our experience is that patients routinely accept that explanation and sign the form without too much thought or discussion”).

183

1-800 CONTACTS (WS Comment #3207); Baker Analysis, Ex. B,

supra

note 133,

https://www.ftc.gov/system/files/summaries/initiatives/677/meeting_summary_for_the_contact_lens_rulemaking_proceeding.pdf

(SSI online survey of 500 respondents).

Some commenters also suggested that the increased burden from the signed acknowledgment would be lessened or even outweighed by a reduced verification burden because with more patients in possession of their prescriptions and able to present them to sellers, fewer verifications would be necessary.

184

1-800 CONTACTS submitted a cost-benefit analysis that concluded that since prescribers and sellers spend considerably more time to comply with the Rule using verification

185

than they do when consumers present prescriptions for purchase, a relatively modest reduction in the number of verifications could have a significant impact on overall compliance costs.

186

According to this analysis, a reduction in verifications of 9% could be sufficient to offset the entire burden of the acknowledgment proposal.

187

The analysis further predicted, based on current consumer behavior, that the proposed amendment was likely to reduce the number of verifications by 15.9% and thus likely to offset much of the cost.

188

184

E.g.,

National Association of Optometrists and Opticians (WS Comment #3208) (“increased access to prescriptions and ease in securing additional copies of one's prescription will reduce the number of verification requests and make the fulfillment process easier and more accurate”); 1-800 CONTACTS (NPRM Comment #3898); Consumers Union (NPRM Comment #3969) (increase in patients with their prescriptions “should significantly reduce the number of prescriptions that require verification”); Costco Wholesale Corporation (NPRM Comment #4281).

See also

CLR Panel V Tr.,

supra

note 50, at 9 (statements of David Cockrell that it would reduce the number of verifications but would not eliminate them).

185

The Commission has estimated that prescribers' offices spend five minutes per verification request, based on information provided by the American Optometric Association. Agency Information Collection Activities; Submission for OMB Review, 81 FR 62501 (Sept. 9 2016) [hereinafter PRA Assessment]. The Commission has also estimated that sellers spend five minutes per verification request, and one minute on recordkeeping in non-verification circumstances (to preserve the prescription when presented by a patient).

Id.

186

Baker Analysis,

supra

note 133, at 12-17.

187

Id.

The estimate is based on the NPRM PRA Assessment estimate of the signed-acknowledgment compliance cost of $10.8 million, and an assumption that 30% of consumers who currently do not receive their prescription would receive them due to the proposed requirement. This calculation is further based on the premise that prescribers are the ones who take the time to respond to verification calls, which is how the FTC has traditionally calculated the verification burden.

See

PRA Assessment,

supra

note 184, at 62501. If the burden were calculated with the assumption that prescribers' office staff handle verification calls rather than prescribers, the verification burden cost would be much less (since staff typically have a much lower hourly wage than prescribers), and consequently, the reduction in verifications would have to be 21% to offset that burden, according to Dr. Baker. Baker Analysis,

supra

note 133, at 16.

188

Id.

This calculation uses (1) an assumption that consumers make two contact lens purchases per year which would otherwise (in the absence of prescription presentation) require verification, and (2) the assumption, based on current consumer behavior, that approximately 38.6% of consumers in possession of their prescription would present them to sellers.

The Commission has some concerns about the analysis performed for 1-800 CONTACTS, since Dr. Baker used certain assumptions that differ from what the Commission has traditionally used in its calculation of the verification burden.

189

The Commission undertook a similar analysis using Dr. Baker's assumption regarding the percentage of consumers who would present prescriptions to sellers, but using assumptions more closely mirroring those used in the Commission's prior Public Record Collection analysis, and calculated that the full cost of the signed acknowledgment might be offset by a 22.9% reduction in verifications.

190

The Commission considers this a relatively rough estimate and does not accord it substantial weight, however, since the calculation relies on a significant number of assumptions, not all of which may be accurate. The calculation also does not take into account any of the benefit to consumers of having their prescriptions and being able to choose from among competing providers; the savings consumers might achieve by purchasing lower-priced lenses; the improvements to health and safety due to a reduction in errors associated with invalid prescriptions currently verified through passive verification; and the Commission's ability to assess and verify compliance with the Rule.

191

189

For example, Dr. Baker assumed two verifications per customer per year, whereas the Commission has typically assumed just one. In addition, the Commission's burden calculation typically limits its estimate of the minutes prescribers spend responding to verification calls to only those calls that they respond to, where Dr. Baker bases his burden estimate on five minutes for each verification call, regardless of whether it requires prescriber action.

See

PRA Assessment,

supra

note 185, at 62501; Agency Information Collection Activities; Proposed Collection; Comment Request, 81 FR 31938, 31939-40 (May 20, 2016); Baker Analysis,

supra

note 133, at 12-17.

190

As noted, this uses the assumption from the Commission's PRA Assessment that prescribers handle verification calls. If that assumption is changed to an assumption that prescribers' staff handle all of the verification calls, the overall cost of the verification burden falls, and consequently the percentage of verification reductions needed to offset the $10.4 million cost of the signed acknowledgment rises to between 43-50%, depending upon whether staff time spent verifying prescriptions but not responding to sellers is included in the calculation.

191

NPRM, 81 FR at 88533.

5. Comments on the Text of the Proposed Acknowledgment Form

Some commenter opposition to the Commission's proposal focused on the text of the acknowledgment form. In particular, some prescribers took issue with the proposed requirement that the acknowledgment form include the statement, “I understand I am free to purchase contact lenses from the seller of my choice.”

192

According to prescribers, this language makes it appear that doctors who sell contact lenses have been misleading their

patients and overcharging them, and actively encourages consumers to buy their lenses elsewhere.

193

192

See, e.g.,

Highsmith (WS Comment #651); Parikh (WS Comment #764).

193

See, e.g.,

CLR Panel V Tr.,

supra

note 50, at 25 (statement of David Cockrell that it implies that doctors have done something wrong); Phillips (WS Comment #701) (“What other industry is required in their place of business to hand a customer a sheet of paper informing the customer you can buy these items elsewhere? Obviously people know there are different choices to get contacts—but why are we being forced to point people away?”); Johnson (WS Comment #755) (“Now I'm supposed to have them sign a document implying that I'm some kind of shady character. When patients lose trust in their doctor, medical care is damaged.”); Hanian (WS Comment #1196) (disclosure “has the impression in the public of making Eye Care Professionals look guilty of non-release”); Frazier (NPRM Comment #2653); Kentucky Optometric Association (NPRM Comment #3174).

While many commenters criticized the proposed language, few suggested alternative wording. One commenter, however, suggested adding the language “valid anywhere” to the prescription itself rather than on an acknowledgment form.

194

Another commenter, Consumers Union, suggested keeping the proposed wording but adding a third sentence to the acknowledgment, stating, “I also understand that my having the copy of my prescription means I can give a copy to the seller I choose.”

195

1-800 CONTACTS said it supported the Commission's proposed language because it would make it more likely patients would be given the prescription earlier in the process and before they purchased lenses from their prescriber.

196

194

Wisconsin Academy of Ophthalmology (NPRM Comment #4152).

195

Consumers Union (NPRM Comment #3969).

196

1-800 CONTACTS (NPRM Comment #3898).

6. Alternative Proposals to the Signed-Acknowledgment Proposal

Some commenters suggested that instead of a signed acknowledgment, the Commission should provide better guidance and increased education.

197

Many commenters suggested, as an alternative, requiring that prescribers post a sign advising patients of their right to their prescription, and said this would help educate consumers without adding as much of a burden for prescribers.

198

According to the AOA, signage is a common tool used to educate patients and consumers in a variety of settings.

199

Furthermore, commenters noted that the state of California already requires that prescribers post just such a sign, and some said the signage was working to remind the public of its rights.

200

The AOA submitted a third-party online survey showing that California contact lens wearers strongly support the requirement and believe the law helps enable patients to find the best prices on contact lenses.

201

197

CooperVision, Inc. (NPRM Comment #3841).

See also, e.g.,

Kochik (WS Comment #729) (“it might be better to mandate that a placard be clearly displayed that states that you are entitled to a copy of your contact lens prescription upon completion of the exam, or run an advertising campaign”); American Optometric Association (NPRM Comment #3830).

198

E.g.,

CLR Panel V Tr.,

supra

note 50, at 12 (statements of David Cockrell); To (WS Comment #597); Smith (WS Comment #732); Schott (WS Comment #1739); Toon (WS Comment #1741); Gibson (WS Comment #1889); Gilthvedt (WS Comment #2205); Health Care Alliance for Patient Safety (WS Comment #3206); American Optometric Association (NPRM Comment #3830); Gridley (NPRM Comment #4150); Letter from Twenty-Four Representatives,

supra

note 131; Letter from Seven Representatives,

supra

note 131; Letter from Fifty-Four Representatives,

supra

note 131; Letter from Fifty-Eight Representatives,

supra

note 131.

199

American Optometric Association (WS Comment #3303).

200

Id.;

Lo (WS Comment #856).

201

American Optometric Association (WS Comment #3303). The survey presented 1000 consumers with a copy of the signage requirement and asked, among other things, “As a contact lens wearer, do you support this law?” to which 96% opted for the answers “definitely support” or “support.” Ninety-three percent said the signage requirement either “helps” or “definitely helps” patients find the best prices on lenses. The survey also asked to what extent respondents agree or disagree with the following statement, “This law is the best way to ensure that contact lens wearers are as informed as possible about their contact lens purchasing options,” and gave the respondents four options, “completely agree,” “agree,” “disagree” and “completely disagree.” Eighty-eight percent selected either “completely agree” or “agree.”

In contrast, other commenters said a sign would be less effective than a signed acknowledgment since consumers might not notice a sign amid other signs and notifications at a prescriber's office, and since a signage requirement might have no effect on the likelihood that doctors release prescriptions without patients having to ask for them.

202

In a survey submitted by 1-800 CONTACTS, 74% of consumer respondents said they are more likely to pay attention to a document presented to them than to a posted sign, while only 5% said they were more likely to pay attention to a posted sign.

203

Others noted that unless a prescriber maintained a record of release, determining whether a prescription had, in fact, been released, would remain a challenge for the Commission.

204

At the Commission's CLR Workshop, there was also discussion as to whether enforcement of the signage requirement could itself be difficult, since in the absence of a sign, consumers would not know to complain, or who to complain to, and the only way to verify compliance with the signage requirement would be for the Commission to perform numerous spot checks across the country.

205

Similarly, a panelist and moderator both mentioned that informal spot checks in California have found that such signs are not universally posted in accordance with state law,

206

although another panelist noted that when his organization looked at eye-care office compliance, the offices “passed the test.”

207

As none of these “spot checks” can be considered scientific or thorough investigations, the Commission will not accord any of them any weight.

202

CLR Panel V Tr.,

supra

note 50, at 12-13 (statements of Linda Sherry); 1-800 CONTACTS (NPRM Comment #3898);

See also

Wisconsin Academy of Ophthalmology (NPRM Comment #4152).

One commenter, the NAOO, suggested that rather than specifying the precise terms of a signed acknowledgment, the Commission should require proof of compliance with the prescription-release requirement but allow the prescriber to select the method of proof from several accepted methods.

212

According to the NAOO, allowing any of several forms of proof would provide a degree of flexibility—thus reducing prescriber burden—while still providing the Commission with more effective enforcement and verification ability than it has today.

213

The NAOO suggested that a prescriber who could not produce credible evidence of prescription release would face a rebuttable presumption of noncompliance.

214

212

National Association of Optometrists and Opticians (WS Comment #3208).

See also

CLR Panel V Tr., supra note 50, at 22 (statements of Joseph Neville).

213

Id. See also

National Association of Optometrists and Opticians (NPRM Comment #3851) (“While many may elect to use a paper or electronic form, others may opt for some form of portal acknowledgment, email or text acknowledgment or other method not yet determined. In this way there is some flexibility for the prescriber, depending on tools used in the practice.”).

214

Id.

The NAOO proposed that accepted forms of proof of prescription release would include: A separate signed acknowledgment (as proposed in the NPRM); a patient-signed acknowledgment of prescription receipt on a prescriber-retained copy of the prescription; a patient-signed acknowledgment of prescription receipt on a customer's purchase receipt; a copy of and transmission receipt of a fax of the prescription to the patient; email and text retention of the sent prescription, including a digital image of the prescription, evidencing the correct address or number for the patient, along with a delivery receipt of sending; portal acknowledgment and evidence of the prescription download; and other forms of retention, whether paper or electronic not yet contemplated, that the Commission can approve in the future based on an adequate showing.

215

According to the NAOO, these choices would allow prescribers to tailor the acknowledgment to their practices, reduce unnecessary paper and storage issues, and yet still provide the Commission with an enforcement mechanism to ensure that prescribers are complying.

216

215

National Association of Optometrists and Opticians (WS Comment #3208).

216

CLR Panel V Tr.,

supra

note 50, at 13-14, 22, 25 (statements of Joseph Neville).

The NAOO also suggested an exemption for prescribers who do not sell contact lenses, since they lack a financial incentive to withhold a prescription.

217

Some other commenters, however, opposed this, stating that it implied that doctors who chose to sell lenses were unethical, and further that it might be difficult to determine whether doctors—particularly those co-located with an optical retailer—have any kind of direct or indirect financial interest in the sale of lenses.

218

217

Id.

at 25-26 (statements of Joseph Neville). Such an exemption was also supported by a few other commenters, such as 1-800 CONTACTS, which noted that this would reduce the overall burden on prescribers without reducing benefits for consumers. 1-800 CONTACTS (WS Comment #3207).

218

See

CLR Panel V Tr.,

supra

note 50, at 26 (statements of David Cockrell) (“How in the world could you look at every commercial contract and know whether that doc who isn't physically selling them is incentivized in any other way, whether it's a decrease in the rent space, whether it's advantage in something else.”);

id.

at 26 (statements of Linda Sherry that it would be simpler to have one law for everyone).

C. Additional Discussion and Proposal

The Commission has reviewed and considered the thoughts and concerns expressed in the more than 7,000 comments submitted in response to its NPRM proposal. Many of the comments were helpful and provided insight into the effectiveness of the current Rule's automatic prescription release provision, the need for amending that provision, the potential burden on providers of doing so, and possible alternatives to the Commission's NPRM proposal.

The Commission also emphasizes that it has great respect for the nation's eye-care professionals, and recognizes the unique contribution they provide in helping America's consumers see clearly and enjoy quality eye health. Congress determined that the benefits patients enjoy from these services are enhanced when they can buy from third-party sellers, and that requiring the automatic release of prescriptions at the completion of the contact lens fitting is the best way to ensure consumer choice. Congress directed the Commission to implement and enforce that requirement, and if the Act and Rule are not functioning as intended, the Commission is obligated to address the deficiency.

After consideration of the comments and evidence at its disposal, the Commission believes that the overall weight of the evidence in the rulemaking record is compelling, and firmly establishes that the Act and Rule are not working as Congress intended. It is evident that a majority of consumers—between 56-65%

219

—are not receiving their contact lens prescriptions automatically as required by law, and millions of consumers are not receiving them at all.

220

This is evident from the surveys previously discussed in the NPRM, as well as the two new consumer surveys and additional corroborating evidence.

219

See supra

Section IV B(2)(a).

220

Id.

While the Commission reiterates that any one survey might not be treated as definitive, the fact that several different surveys over the course of several years have found similar levels of non-compliance is significant. Additional evidence of noncompliance includes the persistently high verification numbers and consumer accounts of failure to release. Moreover, the existing regulatory structure in the U.S., which bars a consumer from obtaining contact lenses without a prescription while permitting prescribers to sell what they prescribe, creates regulatory-based economic incentives for some prescribers to not release prescriptions, or to not release them unless requested by the consumer.

221

See

Information Technology & Innovation Foundation (NPRM Comment #2848) (noting the long history of the optometry industry to use its gatekeeper power to limit patients' ability to purchase lenses from outside sources, and the existing imbalance in that U.S. consumers still need prescribers to give them a prescription in order for them to purchase lenses).

Furthermore, the Commission has not seen credible empirical evidence that contradicts the evidence that prescribers are not automatically releasing prescriptions. For reasons explained in its earlier discussion, the Commission does not regard the relatively small number of consumer complaints as indicative of prescriber compliance. While many prescribers attest—via the

AOA prescriber survey and their own comments—that they personally always provide patients with prescriptions, and the Commission takes these personal declarations into account, they do not rebut the empirical evidence that a substantial number of consumers are not receiving their prescriptions automatically as required by law. Similarly, the evidence in the record supports the conclusion that many consumers are still unaware of their right to their prescription.

222

The Commission therefore continues to believe that compliance with the automatic prescription release provision could, and should, be substantially improved. The Commission also continues to believe, as it has found in the past,

223

that consumers are subject to substantial economic loss attributable to the inability to comparison shop when they do not possess their prescriptions, and that significant harm to competition exists when prescribers do not comply with the prescription-release requirement. 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.

224

222

See supra

Section IV B(2)(a).

223

Contact Lens Rule, 69 FR 5440 (Feb. 4, 2004); Eyeglass I, 43 FR at 24002.

224

Fed. Tr. Comm'n, “The Strength of Competition in the Sale of Rx Contact Lenses: An FTC Study,” 45-46, 50 (2005),

https://www.ftc.gov/sites/default/files/documents/reports/strength-competition-sale-rx-contact-lenses-ftc-study/050214contactlensrpt.pdf.

Furthermore, as noted in its NPRM, the Commission believes that the potential benefit of increasing the number of patients in possession of their prescriptions remains substantial: Increased flexibility and choice for consumers; a reduced verification burden for prescribers and sellers; a reduced likelihood of errors associated with incorrect, invalid, or expired prescriptions and, consequently, improved patient safety; and a reduction in the number of failed attempts at verification or attempts to verify with the wrong prescriber.

225

NPRM, 81 FR at 88532-34.

1. A Confirmation From the Consumer Is Necessary for Enforcement and Monitoring

Additionally, the Commission is convinced that some form of retained documentation is necessary to improve the Commission's enforcement and monitoring ability. As commenters noted, the Commission currently faces notable challenges in enforcing the Rule since typically the only evidence is the word of a complaining consumer against that of the prescriber.

226

This fact has played a role in the lack of enforcement over the last ten years. Under the current Rule, to investigate a complaint and bring an enforcement action, the Commission might be required to issue a Civil Investigative Demand for the names and contact information of a prescriber's recent patients (perhaps within the past two months), and then survey or interview them to ascertain whether they received their prescriptions. The Commission might also have to conduct investigational hearings with prescribers' office staff to determine if there was any proof that prescriptions had been provided. Such an investigation would be resource-intensive for the Commission and costly, time-consuming, and disruptive for a prescriber, even if the Commission never ultimately brought an enforcement action.

226

See supra

Section IV B(3).

The current lack of enforcement, in conjunction with the fact that so few consumers file complaints when they have not received their prescription, is likely a significant contributing factor in why less than half of all patients receive their prescription automatically as required by law. Prescribers, whether intentionally or not, can fail to release prescriptions yet risk very little, since if a patient asks for the prescription and subsequently receives it, the consumer is unlikely to file a complaint.

While some commenters questioned whether prescribers who do not comply with prescription release would comply with the acknowledgment requirement, the Commission notes that the difference between the two requirements is that there would be a verifiable method to check the latter. If the Commission has concerns about a prescriber's compliance, the Commission can simply request to see the patient acknowledgment, and that should resolve most questions as to whether the prescriber did or did not provide a prescription.

As for commenters who complained that the proposed acknowledgment does not directly improve patients' health and safety, or address so-called questionable practices by third-party sellers,

227

that assertion even if accurate, is irrelevant, because the acknowledgment proposal is not intended to do so. Other parts of the Rule are designed to focus on verification and prescription alteration, both of which may affect patient health and safety. The prescription-release component of the Rule is designed to enhance consumer choice, and the Commission's proposed acknowledgment is targeted to achieve that goal. And while it may be true, as some commenters have asserted, that not every single consumer would read the acknowledgment form, the Commission believes that enough patients would read a document handed to them and asked to sign to make such a requirement beneficial (particularly if it increases the number who receive their prescriptions). As noted

supra,

a survey of consumers found that a significant majority were more likely to pay attention to a document given to them than to a posted sign.

228

Furthermore, the contention that consumers will not read the acknowledgment form runs contrary to the comments of many prescribers who predict that consumers will ask a lot of questions after reading the form.

227

See supra

note 167 and accompanying text.

228

Baker Analysis, Ex. B,

supra

note 133, at 9.

2. The Burden Is Relatively Small and Outweighed by the Benefits

The Commission also finds that the evidentiary record does not establish that the burden to obtain a signature and retain a single sheet of paper or electronic record is as extreme as that forecast by many prescribers. As the Commission noted in the NPRM, the majority of states already require that optometrists maintain records of eye examinations for three years, and maintaining an additional piece of paper should not take more than a few seconds of time, as well as inconsequential, or

de minimis,

amount of record space.

229

This recordkeeping burden can be further reduced to the extent that prescribers adopt, or have adopted, electronic-health record systems where patient signatures can be recorded electronically and inputted automatically into the electronic record.

230

The Commission also believes that while the precise offset resulting from reduced verifications may be difficult to predict with precision, there would undoubtedly be some offsetting benefits for both sellers and prescribers.

231

229

NPRM, 81 FR at 88557.

230

Id.

at 88534.

231

See supra

Section IV B(4).

The argument put forth in some comments that the cost of the Rule's burden falls disproportionately on prescribers, and that this proposal aggravates that imbalance, is not persuasive. In the first place, the signed-acknowledgment proposal is intended to remedy lack of compliance with the

automatic-release provision

by prescribers.

Furthermore, while Congress recognized the health issues associated with selling contact lenses without a prescription, the FCLCA was enacted primarily because of prescribers' widespread failure to release and verify prescriptions,

232

and Congress set out nearly all of the requirements and corresponding burdens imposed on prescribers and sellers. The primary inquiry for the Commission is to determine whether the Rule is functioning to ensure compliance with the Act. The Commission's focus is to find the most effective and least burdensome way to achieve compliance with the Rule and the Act, and thereby benefit consumers.

232

H.R. Rep. No. 108-318 at 4-5.

See also

69 FR at 40492 (quoting FCLCA co-sponsor Rep. F. James Sensenbrenner, Jr., stating that the intent of the Act is “to allow consumers to receive their contact lens prescriptions so they can easily shop around to buy their lenses from any number of suppliers.”).

While prescribers predicted that consumers would have many questions about having to sign a receipt for their prescription, the only submitted empirical survey of consumer understanding of the proposal found that just 4% of consumers surveyed had questions about the acknowledgment form, and it took consumers, on average, a mere twelve seconds to read it. And as one commenter noted, consumers are accustomed to tasks such as this.

233

Indeed, many pharmacists require patients to acknowledge that they do not have any questions upon receiving a prescription; package services require signature upon delivery; schools require signed permission slips; businesses and physicians' offices require visitors to sign in; and, as some commenters noted, patients are accustomed to signing acknowledgment forms signifying they are in receipt of a provider's HIPAA notice of privacy practices.

234

233

See

CLR Panel V Tr.,

supra

note 50, at 7 (statements of Linda Sherry that she did not think it would raise a lot of questions from consumers).

234

Costco Wholesale Corporation (NPRM Comment #4281).

See also

Searrles, NPRM Comment #3304) (stating that from his experience as a pharmaceutical doctor, he finds it difficult to understand how some eye doctors would find it difficult to maintain a file of signatures).

The HIPAA acknowledgment requirement

235

faced some similar objections prior to implementation, including complaints that it would be burdensome, present difficulties when patients and doctors are not face-to-face, and be more difficult and costly to implement than signage.

236

The U.S. Department of Health and Human Ser

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