[Federal Register Volume 89, Number 144 (Friday, July 26, 2024)]
[Rules and Regulations]
[Pages 60742-60789]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-15620]



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Vol. 89

Friday,

No. 144

July 26, 2024

Part III





Federal Trade Commission





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16 CFR Part 456





Ophthalmic Practice Rules (Eyeglass Rule); Final Rule

  Federal Register / Vol. 89 , No. 144 / Friday, July 26, 2024 / Rules 
and Regulations  

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FEDERAL TRADE COMMISSION

16 CFR Part 456

RIN 3084-AB37


Ophthalmic Practice Rules (Eyeglass Rule)

AGENCY: Federal Trade Commission.

ACTION: Final rule.

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SUMMARY: The Federal Trade Commission (``FTC'' or ``Commission'') is 
publishing a final rule to implement amendments to the Ophthalmic 
Practice Rules (``Eyeglass Rule'' or ``Rule''). These amendments 
require that prescribing eye care practitioners obtain a signed 
confirmation after releasing an eyeglass prescription to a patient and 
maintain each such confirmation for a period of not less than three 
years. The Commission is permitting prescribers to comply with 
automatic prescription release via electronic delivery if they first 
obtain verifiable affirmative consent from the patient and maintain a 
record of such consent for a period of not less than three years. The 
amendments further clarify that the presentation of proof of insurance 
coverage shall be deemed to be a payment for the purpose of determining 
when a prescription must be provided. Finally, the Commission amends 
the term ``eye examination'' to ``refractive eye examination'' 
throughout the Rule.

DATES: This rule is effective September 24, 2024.

FOR FURTHER INFORMATION CONTACT: Alysa S. Bernstein, Attorney, (202) 
326-3289; Sarah Botha, Attorney, (202) 326-2036; or Paul Spelman, 
Attorney, (202) 326-2487, Division of Advertising Practices, Bureau of 
Consumer Protection, Federal Trade Commission, 600 Pennsylvania Avenue 
NW, Washington, DC 20580.

SUPPLEMENTARY INFORMATION:

Statement of Basis and Purpose

Table of Contents

I. Background
    A. Overview of the Eyeglass Rule
    B. Background of Prescribers' Failure To Release Prescriptions 
and the Commission's Automatic-Release Remedy
    C. Evidentiary Standard for Promulgating or Amending the Rule
    D. The Current Eyeglass Rule Review
    1. Advance Notice of Proposed Rulemaking
    2. The Contact Lens Rule Review
    3. The Notice of Proposed Rulemaking and Eyeglass Rule Workshop
    4. Overview of the Final Rule
    5. The Eyeglass Marketplace
II. Final Rule Pertaining to the Automatic-Prescription-Release 
Provision
    A. Separation of Examination and Dispensing
    1. Comments and Evidence Regarding the Automatic-Prescription-
Release Provision
    a. Prescriber Compliance With Automatic Release, and Consumer 
Receipt of Their Prescriptions
    b. Whether the Automatic-Release Provision Is Still Necessary 
and Beneficial for Consumers
    2. Analysis of Evidence Regarding Failure To Release 
Prescriptions
    B. The Remedy for Failure To Release Prescriptions Remains the 
Automatic-Release Requirement
    C. Commission Determination To Update the Rule To Clarify 
Requirements for Prescription Release
III. Final Rule Pertaining to Affirmative Consent to Digital 
Delivery of Eyeglass Prescriptions
    A. Digital Delivery Option in the NPRM and the Basis for Such 
Amendment
    B. Comments on the NPRM and Discussion at the Workshop Regarding 
the Proposal To Permit Digital Delivery of the Eyeglass Prescription 
With Patient's Affirmative Consent
    1. Comments About the Benefits and Burdens of the Proposed 
Affirmative Consent to Digital Delivery Provision
    2. Comments in Favor of Allowing Prescribers To Choose Whether 
To Offer Digital Delivery of Prescriptions
    3. Comments Regarding Giving Patients a True Choice as to How To 
Have Their Prescription Delivered
    C. Additional Discussion and Commission Determination Regarding 
the Affirmative Consent to Digital Delivery
    1. Final Rule Determination To Add Option for Digital Delivery 
of Eyeglass Prescriptions
    2. Final Rule Moves Requirement for Obtaining Patient's 
Verifiable Affirmative Consent for Digital Delivery to a New Section 
and Out of Definitions
    3. Final Rule Adds Explicit Recognition of the Ability To Obtain 
Affirmative Consent on Paper or in a Digital Format
    4. Final Rule Clarifies That Digital Delivery Methods Identified 
in Affirmative Consent Request Must in Fact Be Used
IV. Final Rule Pertaining to Confirmation of Prescription Release
    A. Proposed Confirmation Requirement in the NPRM and the Basis 
for Such Proposal
    B. Comments on the NPRM and Discussion at the Workshop Regarding 
Confirmation of Prescription Release
    1. Comments in Favor of Confirmation-of-Prescription-Release 
Proposal
    2. Comments Against the Confirmation-of-Prescription-Release 
Proposal
    3. Comments About the Exemption for Prescribers Who Do Not Have 
a Direct or Indirect Financial Interest in the Sale of Eyeglasses
    4. Comments About Alternatives to the Confirmation-of-
Prescription-Release Proposal
    C. Additional Discussion and Commission Determination Regarding 
the Confirmation-of-Prescription-Release Proposal
    1. Final Rule Determination To Amend the Rule To Require 
Confirmation of Prescription Release
    a. Alternatives to Confirmation of Prescription Release Not 
Adopted
    b. The Burdens of the Confirmation of Prescription Release Are 
Not Substantial
    c. Exemption for Prescribers Who Do Not Have a Direct or 
Indirect Financial Interest in the Sale of Eyeglasses
    2. Comments About Options for Obtaining the Confirmation and 
Commission Determination
    a. Comments at the Eyeglass Rule Workshop
    b. Commission Determination Regarding Options for Obtaining the 
Confirmation
    3. Final Rule Modification To Add Explicit Recognition of a 
Prescriber's Ability To Obtain a Confirmation on Paper or in a 
Digital Format
V. Final Rule Pertaining to Proof of Insurance Coverage as Payment
    A. Proposed Requirement in the NPRM To Treat Proof of Insurance 
Coverage as Payment and the Basis for Such Proposal
    B. Comments on NPRM and Discussion at Workshop Regarding the 
Insurance Coverage as Payment Proposal
    C. Additional Discussion and Commission Determination Regarding 
the Insurance Coverage as Payment Proposal
VI. Final Rule Regarding ``Eye Examination'' Terminology
    A. Proposed Revision in the NPRM To Change ``Eye Examination'' 
Term to ``Refractive Eye Examination'' and the Basis for Such 
Proposal
    B. Comments on NPRM and Discussion at Workshop Regarding the 
``Refractive Eye Examination'' Proposal
    1. Comments About the Proposed Terminology Change
    2. Comments About the Need To Allow Prescribers To Make a 
Medical Decision To Withhold the Prescription, Where Appropriate
    3. Comments About the Permissibility To Charge for the 
Refraction, as Opposed To Charging for the Prescription Release
    C. Additional Discussion and Commission Determination Regarding 
the ``Refractive Eye Examination'' Proposal
VII. Miscellaneous Issues Raised in Comments
    A. Pupillary Distance
    1. Background and Comments
    2. Pupillary Distance Requirement Determination
    B. Consumer and Business Education
VIII. Paperwork Reduction Act
    A. Comments Regarding the NPRM Estimate for the Confirmation-of-
Prescription-Release Requirement
    B. Commission Estimate of the Total Burden = 3,208,333 Hours
    1. Estimated Hour Burden of 1,375,000 Hours for Prescribers To 
Release Prescriptions
    2. Estimated Hour Burden of Prescribers' Staff To Obtain and 
Store Patient Confirmation of Prescription Release = 1,375,000 Hours 
(343,750 Hours for Patients To Read and Sign Confirmations, 
1,031,250 Hours for Prescribers' Offices To Scan and Store Such 
Confirmations)

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    3. Estimated Hour Burden on Prescribers' Offices To Obtain and 
Store Patient Consents to Electronic Delivery = 458,333 Hours 
(114,583 Hours To Obtain Signed Consents and 343,750 Hours To Store 
Same)
    C. Estimated Labor Cost
    D. Capital and Other Non-Labor Costs
IX. Final Regulatory Analysis and Regulatory Flexibility Act 
Analysis
    A. Need for and Objectives of the Final Rule
    B. Significant Issues Raised by Public Comments in Response to 
the IRFA and the Agency's Response, Including Any Changes Made in 
the Final Rule
    C. Description and Estimate of the Number of Small Entities to 
Which the Amendments Will Apply or Explanation Why No Estimate Is 
Available
    D. Description of the Projected Reporting, Recordkeeping and 
Other Compliance Requirements of the Amendments, Including an 
Estimate of the Classes of Small Entities That Will Be Subject to 
the Requirement and the Type of Professional Skills That Will Be 
Necessary To Comply
    E. Steps Taken To Minimize the Significant Impact, if Any, of 
the Amendments, Including Why Any Significant Alternatives Were Not 
Adopted
X. Congressional Review Act

I. Background

A. Overview of the Eyeglass Rule

    The Eyeglass Rule (16 CFR part 456) declares it an unfair practice 
for an optometrist or ophthalmologist to fail to provide a patient with 
a copy of the patient's eyeglass prescription immediately after an eye 
examination is completed.\1\ The prescriber may not charge the patient 
any fee in addition to the prescriber's examination fee as a condition 
of releasing the prescription to the patient.\2\ The Rule defines a 
prescription as the written specifications for lenses for eyeglasses 
which are derived from an eye examination, including all of the 
information specified by State law, if any, necessary to obtain lenses 
for eyeglasses.\3\
    The Rule prohibits an optometrist or ophthalmologist from 
conditioning the availability of an eye examination on a requirement 
that the patient agree to purchase ophthalmic goods from the 
ophthalmologist or optometrist.\4\ The Rule also prohibits the 
prescriber from placing on the prescription, or requiring the patient 
to sign, or deliver to the patient, a waiver or disclaimer of 
prescriber liability or responsibility for the accuracy of the exam or 
the ophthalmic goods and services dispensed by another seller.\5\
    The Rule was implemented after findings that many consumers were 
being deterred from comparison shopping for eyeglasses because eye care 
practitioners would not release prescriptions, even when requested to 
do so, or charged an additional fee for release of the prescription. 
The Rule's operative provision, which requires prescription release and 
prohibits fees and waivers for prescription release, is entitled 
``Separation of Examination and Dispensing.'' \6\ Keeping the exam 
process and prescription separate from the retail sale of eyeglasses is 
the key underpinning of the Rule.

B. Background of Prescribers' Failure To Release Prescriptions and the 
Commission's Automatic-Release Remedy

    The FTC has been regulating the optical goods industry for more 
than six decades, and this experience continues to inform and guide the 
Rule. As early as 1962, the Commission took steps to protect consumers 
and competition by adopting the ``Guides for the Optical Products 
Industry,'' declaring it an unfair practice to ``tie in or condition'' 
refraction services to eyeglass sales when there was a ``reasonable 
probability'' of harming competition.\7\ However, the Guides were not 
binding, the FTC never sought to enforce them, and prescribers did not 
comply with them.\8\ In light of such non-compliance, on June 2, 1978, 
the Commission issued the Advertising of Ophthalmic Goods and Services 
Rule (the ``Eyeglass I Rule''), which, among other things, contained 
the provision ``Separation of Examination and Dispensing'' requiring 
prescribers to automatically release prescriptions--regardless of 
whether or not patients requested them--so as to draw a line between 
exams and eyeglass sales, and ensure consumers had unconditional access 
to prescriptions.\9\ The Commission found that consumers suffered 
substantial economic loss and lost opportunity costs due to an 
inability to comparison-shop for glasses,\10\ and that such practices 
offended public policy and inhibited competition by denying consumers 
the ability to use available information.\11\ The Commission explained 
that while it considered requiring prescriptions be released only upon 
request, it chose ``automatic release'' due to consumers' lack of 
awareness of their prescription rights, and to immunize such rights 
from an ``evidentiary squabble'' over whether a consumer did or did not 
request their prescription.\12\
    Upon issuance of the Eyeglass I Rule, the American Optometric 
Association (``AOA'') filed suit, and the D.C. Circuit upheld the 
automatic-release requirement, finding there was ``extensive'' evidence 
that withholding prescriptions harmed consumers.\13\ The court also 
noted there was considerable evidence that prescribers used certain 
practices ``to frighten consumers'' into purchasing from the 
prescriber.\14\
    In 1985, the Commission re-reviewed the Rule and held public 
hearings, after which FTC staff proposed changing to release-upon-
request,\15\ due to what staff perceived to be altered market 
conditions and increased public awareness, and the challenges staff 
faced trying to enforce the automatic-release provision.\16\ According 
to staff at that time, automatic release had not prevented evidentiary 
squabbles,\17\ but rather increased them, since whether a prescriber 
released a prescription could not, in most cases, be ascertained 
without documentary evidence.\18\ In contrast, the hearing officer 
recommended the automatic-release requirement remain in effect, since 
prescribers were still not releasing prescriptions to consumers.\19\ 
The Commission sided with the presiding officer's recommendation and 
issued the ``Eyeglass II Rule,'' which preserved automatic release.\20\ 
The Rule was again challenged in court and parts of it were vacated, 
but not the automatic-release component, which remained lawful and in 
effect.\21\
    In 1997, the Commission again sought input on the Rule's 
prescription-release requirement but withheld taking action while it 
evaluated whether contact lenses should be covered by the Rule.\22\ 
That question was resolved by Congress, which passed the Fairness to 
Contact Lens Consumers Act (``FCLCA''),\23\ directing the FTC to issue 
a separate rule with automatic prescription-release requirements for 
contact lenses that were similar to those required by the Eyeglass 
Rule.\24\
    When the Commission looked again at the Eyeglass Rule in 2004, it 
determined that prescribers continued to withhold prescriptions, and 
consumers were still not sufficiently aware of their rights.\25\ The 
Commission felt that were it to eliminate the automatic-release remedy, 
even more prescribers might fail to release prescriptions. Due to this, 
and because the Commission found that prescription-release enhanced 
consumer choice at minimal cost, the Commission opted to again retain 
the automatic-release remedy.\26\ By retaining the requirement, the 
Commission also ensured that prescription-release requirements for 
eyeglasses and contact lenses would be largely aligned.\27\

C. Evidentiary Standard for Promulgating or Amending the Rule

    The Commission promulgated the Eyeglass Rule under section 18 of 
the FTC Act, which grants the Commission

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the authority to adopt rules defining unfair or deceptive acts or 
practices in or affecting commerce.\28\ When amending or repealing the 
Rule, the Commission follows the same section 18 procedures governing 
the adoption of rules \29\ and, in doing so, engages in a multi-step 
inquiry. To make a determination that an act or practice is unfair, the 
Commission evaluates the following questions: (1) Does the act or 
practice cause or is it likely to cause substantial injury to 
consumers? (2) Is the injury to consumers outweighed by countervailing 
benefits that flow from the act or practice at issue? and (3) Can 
consumers reasonably avoid the injury? \30\
    If an act or practice is deemed unfair, the Commission may issue a 
notice of proposed rulemaking under section 18 only where it has 
``reason to believe'' that the unfair act or practice at issue is 
``prevalent.'' \31\ The Commission can find prevalence where 
information available to it indicates a widespread pattern of 
conduct.\32\ The evidence necessary to answer the aforementioned 
questions will vary depending on the circumstances of each rulemaking 
and the characteristics of the industry involved.\33\ When inviting 
public comment, the Commission requests that commenters provide useful 
factual data, and, in particular, empirical data such as surveys or 
other methodologically sound quantitative analyses.\34\ The Commission 
may also consider other reliable evidence and input from experts.\35\ 
Documentary and testimonial evidence, and the absence of any 
substantial or persuasive contrary evidence, may also be 
considered.\36\ Once the Commission finds that an unfair act or 
practice is prevalent, the Commission has wide latitude in fashioning a 
remedy, and need only show a ``reasonable relationship'' between the 
unfair act or practice and the remedy.\37\

D. The Current Eyeglass Rule Review

1. Advance Notice of Proposed Rulemaking
    In 2015, as part of a periodic review of its rules and regulations, 
the Commission simultaneously published notices in the Federal Register 
initiating reviews of both the Eyeglass Rule and the Contact Lens Rule. 
The Commission published a request for comment (``RFC'') seeking public 
input on the efficiency, costs, benefits, and regulatory impact of the 
Contact Lens Rule, including its prescription release requirement.\38\ 
The Commission published an advance notice of proposed rulemaking 
(``ANPR'') for the Eyeglass Rule inviting comments on, among other 
things: the continuing need for the Rule; the Rule's economic impact 
and benefits; and the effect on the Rule of any technological, 
economic, or other industry changes.\39\ The Commission also sought 
comment on whether: the definition of ``prescription'' should be 
modified to include pupillary distance, to require that a prescriber 
provide a duplicate copy of a prescription to a patient who does not 
have access to the original, and to require that a prescriber provide a 
copy to or verify a prescription with third parties authorized by the 
patient.\40\
    In response to its Eyeglass Rule ANPR, the Commission received and 
considered 868 comments from a variety of individuals and entities, 
including ophthalmologists, optometrists, opticians, trade 
associations, consumers (and consumer-advocacy representatives), and 
eyeglass sellers.\41\ Virtually all comments supported retaining the 
Rule. Some commenters, including trade associations representing 
opticians and retailers who employ optometrists and opticians, stated 
that the Rule is needed because some prescribers are still not 
automatically releasing prescriptions, and some consumers face 
resistance when they try to obtain their prescriptions.\42\ The AOA, on 
the other hand, questioned the continued need for the Rule based on its 
view that optometrists widely comply with the Rule's requirements, but 
also commented that the Rule--as currently codified--is not necessarily 
harmful.\43\
2. The Contact Lens Rule Review
    The Commission focused on finalizing changes to the Contact Lens 
Rule (CLR) before considering amendments to the Eyeglass Rule. During 
its CLR review, the Commission considered over 8,000 comments and 
issued both a notice of proposed rulemaking \44\ and a supplemental 
notice of proposed rulemaking \45\ (``SNPRM'') before issuing a final 
rule on August 17, 2020.\46\ While the CLR differs from the Eyeglass 
Rule in some respects, many of the issues and concerns regarding 
prescription release and portability are the same, and therefore, some 
of the comments and data submitted during the CLR review are pertinent 
to the Commission's review of the Eyeglass Rule.
    In its CLR final rule, the Commission determined that the 
evidentiary record, as well as the Commission's enforcement and 
oversight experience, demonstrated that prescriber compliance with the 
automatic-prescription-release requirement was deficient, and as a 
result, millions of consumers were not receiving their contact lens 
prescriptions as required by law.\47\ The Commission further found that 
many consumers remained unaware that they have a right to their 
prescriptions.\48\ To remedy this, the Commission implemented a 
confirmation-of-prescription-release provision, requiring that 
prescribers request that patients confirm receipt of their contact lens 
prescription.\49\ According to the Commission, the patient confirmation 
requirement was intended to, among other things, increase the number of 
patients in possession of their contact lens prescription, improve 
flexibility and choice for consumers, foster improved competition in 
the market, and result in lower prices and more efficient contact lens 
sales for consumers.\50\ The Commission noted that the requirement 
would also increase the Commission's ability to enforce and assess the 
CLR.\51\
    The final CLR included an additional amendment addressing a concern 
relevant to the Eyeglass Rule review, in that the Commission recognized 
the value in allowing prescribers to deliver prescriptions to patients 
digitally, so long as prescribers provide the prescription in a format 
that can be accessed, downloaded, and printed by the patient, and the 
patient agrees to receive their prescription in the format identified 
by the prescriber.\52\ The final CLR expressly made this permissible by 
adding a definition of the term ``provide to the patient a copy'' to 
allow the prescriber to provide the patient with a digital copy of the 
prescription in lieu of a paper copy, so long as the prescriber adheres 
to certain requirements.\53\
3. The Notice of Proposed Rulemaking and Eyeglass Rule Workshop
    After the amended CLR final rule took effect, the Commission 
resumed its review of the Eyeglass Rule. Based on a review of comments 
received in response to the ANPR, a regulatory review of the CLR, and 
the Commission's enforcement experience, the Commission issued a notice 
of proposed rulemaking (``NPRM'') on January 3, 2023.\54\ In the NPRM, 
the Commission proposed to: (1) require that prescribers obtain a 
signed confirmation after releasing an eyeglass prescription to a 
patient, and maintain each such confirmation for a period of not less 
than three years; (2) permit prescribers to comply with automatic 
prescription release via electronic delivery if the prescription is 
provided in a digital format that can be accessed, downloaded, and 
printed by the patient,

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and if the prescriber obtains the patient's verifiable affirmative 
consent to the electronic delivery method; (3) clarify that the 
presentation of proof of insurance coverage shall be deemed to be a 
payment for the purpose of determining when a prescription must be 
provided; and (4) amend the term ``eye examination'' to ``refractive 
eye examination'' throughout the Rule.
    In response to the NPRM, the Commission received 27 comments from 
various individuals and entities, including consumers, optometrists, 
ophthalmologists, opticians, trade associations, consumer advocates, 
and eyeglass sellers.\55\ The Commission also announced it would hold a 
public workshop to consider: the proposed confirmation-of-prescription-
release requirement for eyeglass prescriptions; consumers' and 
prescribers' experiences with the implementation of the similar 
requirement for contact lens prescriptions; other proposed changes to 
the Rule; and other issues raised in response to the NPRM.\56\ The 
workshop notice invited interested parties to request to participate as 
a panelist or to file a comment.\57\ Staff convened the workshop, 
titled ``A Clear Look at the Eyeglass Rule,'' with three panels and a 
total of 13 panelists in Washington, DC, on May 18, 2023, and the 
discussion was transcribed.\58\ At the conclusion of the workshop, 
panelists, audience members, and the general public were invited to 
share additional views, data, and other information related to the NPRM 
and the subjects discussed, after which the Commission received an 
additional 20 comments, providing further perspectives from consumers, 
prescribers, opticians, trade associations, and retailers, as well as a 
U.S. Congressman.\59\
4. Overview of the Final Rule
    The Commission now issues this final rule that largely adopts the 
amendments proposed in the NPRM, with some minor modifications based on 
public comments and other considerations, as discussed below. In 
issuing this final rule, the Commission has relied on an extensive 
record that includes comments received in response to the ANPR, the 
NPRM, and the workshop notice. The Commission also relies on the 
discussion at the May 2023 workshop, the Commission's experience 
enforcing the Eyeglass Rule and Contact Lens Rule, and the rulemaking 
record for the 2020 amendments to the CLR, to the extent that such 
record is pertinent to the Eyeglass Rule.\60\ The Commission has also 
examined the current state of the marketplace, and the content of 
consumer complaints about prescriber practices. Further, the Commission 
remains cognizant of the lengthy regulatory history and evidentiary 
record pertaining to prescribers' failure to release prescriptions, and 
eyewear-specific market incentives (such as that many eye doctors sell 
the same items that they prescribe) that provided the initial impetus 
for both the Eyeglass Rule and the CLR.
    Based on the entirety of the record, the Commission finds that 
prescribers' failure to provide consumers with prescriptions at the 
completion of an eye exam--held to be an unfair act or practice when 
the Eyeglass Rule was enacted \61\--remains prevalent, and tens of 
millions of Americans every year are not receiving their eyeglass 
prescriptions as required.\62\ The Commission also finds that 
significant harm to consumers continues to exist and that, without the 
Rule's requirements, consumers could not reasonably avoid the injury 
resulting from the unfair acts and practices prohibited by the Rule. 
The Commission further determines that the Rule's automatic-release 
requirement remains the best remedy for failure to release 
prescriptions, and that documentation of prescription release is 
necessary to better effectuate and enforce this remedy. Consequently, 
the Commission is amending the Rule to implement a confirmation-of-
prescription-release requirement similar to that already in place under 
the amended CLR, albeit a simpler version.\63\ Pursuant to these 
amendments, prescribers will be required to do one of the following:
    (i) If a paper copy of the prescription was provided to the 
patient, request that the patient acknowledge receipt of the 
prescription by signing a separate statement on paper or in a digital 
format confirming receipt of the prescription; or
    (ii) 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.
    As with the CLR provision, this final rule provides sample language 
for the confirmation option, but also allows prescribers to craft their 
own confirmation wording if they so desire. As with the CLR's 
confirmation requirement, the requirement for eyeglass prescriptions 
would apply only to prescribers with a financial interest in the sale 
of eyeglasses.
    The Commission believes that revising the automatic-release remedy 
to require a confirmation of prescription release will provide an 
educational benefit to consumers and prevent consumer harm. This 
amendment is necessary due to demonstrated failures of prescribers to 
comply with the automatic-release remedy, and to ensure the separation 
of eye examination and eyeglass dispensing, which engenders a 
competitive marketplace for eyeglasses. The Commission is sensitive to 
any additional burden that this rule change imposes. However, it finds 
that this amendment maximizes the benefits of comparison-shopping while 
imposing a relatively small cost. The potential benefit of increasing 
the number of patients in possession of their prescriptions is 
substantial: namely, increased flexibility and choice for consumers; 
increased competition among eyeglass sellers; a reduced likelihood of 
errors associated with incorrect, invalid, and expired prescriptions, 
and consequently, improved patient safety; and an improved ability for 
the Commission to enforce and monitor prescriber compliance.
    The confirmation requirement also brings the prescription-release-
related provisions of the Rule into congruence with those of the CLR, 
thereby reducing the confusion and complexity that arise for both 
consumers and prescribers from having inconsistent requirements for 
eyeglass and contact lens prescriptions. In addition, because the CLR 
already obligates ophthalmologists and optometrists to obtain a 
confirmation and maintain a record, their marginal cost associated with 
the confirmation requirement in the Eyeglass Rule should be extremely 
low. Prescribers in compliance with the CLR should already have in 
place forms, systems, and staff training for prescription release, and 
should only need to make minor adjustments for eyeglass prescriptions.
    The Commission is also amending the Rule to permit prescribers to 
comply with automatic prescription release via electronic delivery in 
certain circumstances. In order to do so, the prescriber must identify 
the delivery method to be used--such as portal, text, or email--and the 
prescription must be provided in a format that can be accessed, 
downloaded, and printed by the patient. Further, a prescriber may only 
opt for digital delivery after obtaining the patient's verifiable 
affirmative consent, and must maintain evidence of that consent for a 
period of not less than three years. The Commission is also revising 
the Rule to clarify that presentation of proof of insurance coverage 
shall be deemed a payment for the purpose of determining when a 
prescription must be provided

[[Page 60746]]

under 16 CFR 456.2(a). Again, these revisions harmonize the Eyeglass 
Rule with the existing Contact Lens Rule, which should reduce confusion 
and complexity. And lastly, the Commission is further clarifying that 
the term ``eye examination'' in the Rule refers to a refractive eye 
exam, and is amending that term accordingly.
    This final rule summarizes the public comments the Commission 
received, and explains why the Commission continues to believe that the 
Rule and its automatic-prescription-release provision are necessary. It 
also explains the Commission's rationale for adopting the amendments 
previously proposed in the NPRM, with some minor modifications.\64\ 
Finally, this final rule sets forth the Commission's regulatory burden 
analyses under the Regulatory Flexibility and Paperwork Reduction Acts, 
as well as the regulatory text of the final rule.
5. The Eyeglass Marketplace
    The retail vision care industry in the United States consists of 
several types of participants, namely ophthalmologists, optometrists, 
opticians, and eyewear retailers. The services provided by these 
different participants often overlap, and different participants often 
have business affiliations with each other.
    Ophthalmologists are medical doctors who specialize in treating 
diseases of the eye. They are the only eye care professionals who can 
treat all eye and vision-system diseases, perform eye surgery, 
prescribe nearly all manner of drugs, and use any treatment available 
to licensed physicians. Ophthalmologists can prescribe and sell 
eyeglasses and contact lenses, and their offices may be attached to an 
associated optical dispensary. Ophthalmologists have typically 
completed four years of college, four years of medical school, a year 
of general internship, and three years of specialized hospital 
residency training in ophthalmology. It is estimated that there are 
approximately 18,000 active ophthalmologists in the United States.\65\ 
Many ophthalmologists, especially those who specialize in surgery or 
particular eye conditions, do not sell eyewear, although some do.
    Optometrists are doctors of optometry. They have not completed 
medical school, but have instead completed four years of medical 
training in optometry school, typically following a four-year college 
degree. They are trained and licensed to examine eyes, diagnose 
refractive problems, prescribe and dispense eyeglasses and contact 
lenses, and detect eye disease.\66\ As with ophthalmologists, 
optometrists can prescribe and sell eyeglasses and contact lenses, and 
their offices are often attached to, or part of, an associated optical 
dispensary. A government estimate reports that in 2020 there were some 
43,000 active optometrists in the United States.\67\ While professional 
services--such as eye health and refraction examinations--generate 
significant revenue for optometrists, the majority of optometrists 
still derive a larger percentage of their income from product sales, 
including the sale of eyeglasses and contact lenses.\68\ According to 
some estimates, product sales typically account for roughly 45 to 60% 
of optometrist revenue.\69\
    Opticians, also known as dispensing opticians or ophthalmic 
dispensers, act primarily as retail providers of eyeglasses and contact 
lenses. Opticians fabricate, fit, adjust, and repair eyeglasses, 
primarily on the basis of prescriptions issued by optometrists and 
ophthalmologists. Opticians typically are not authorized to examine 
eyes to determine prescriptions, but may conduct pupillary distance 
examinations in order to fit a pair of eyeglasses to an individual. 
According to one source, twenty-one States currently require opticians 
to obtain licenses,\70\ usually through a State-approved course of 
study and completion of an exam. The remaining States have no formal 
requirements for practice, but many opticians in these States complete 
some form of apprenticeship or training. A 2020 estimate put the number 
of active opticians in the United States at approximately 73,000.\71\ 
Opticians sometimes co-locate their optical dispensaries with 
examination offices of optometrists or ophthalmologists and, sometimes, 
although not always, share revenue from the sale of eyeglasses and 
contact lenses.
    Eyewear retailers are companies and independent merchants that sell 
glasses. They often are owned by, employ, or associate themselves with, 
ophthalmologists, optometrists, and opticians. Some are considered 
independent optical retailers (defined as a retailer with three or 
fewer locations that has either an ophthalmologist, optometrist, 
optician, or optical retailer on site \72\), while others may be 
optical chain stores, such as LensCrafters and America's Best, mass 
merchandisers, such as Costco and Sam's Club, department stores, such 
as Macy's, or online entities, such as Zenni Optical and 
GlassesUSA.com.
    The overall retail eyeglass market continues to grow in both the 
number of eyeglass wearers as well as the number of eyeglasses 
purchased. It is currently estimated that approximately 165 million 
American adults regularly wear prescription eyeglasses, representing 
nearly two-thirds of the country's adult population,\73\ and the 
overall market for eyeglass frames and lenses is estimated at $35.6 
billion.\74\ That represents an 18% increase in value from 2019.\75\
    An industry report found that more than half of Americans surveyed 
between January 10 and March 19, 2023 had had an eye exam within the 
previous twelve months, and of those who had an eye exam in the 
previous three months and use eyeglasses, 50% purchased new 
eyewear.\76\ While online eyeglass sales have increased significantly 
(in just the four years of 2019-2022, online sales of frames and lenses 
nearly doubled from $1.82 billion to $3.24 billion),\77\ roughly four 
out of five eyeglass purchases still occur in person.\78\ Furthermore, 
of those who have an eye exam and proceed to purchase eyeglasses, the 
vast majority purchase from their prescriber on the day of the 
exam.\79\ This is often referred to as a prescriber's ``capture rate,'' 
\80\ and remains relatively high for a variety of reasons, even though 
the average unit price for frames and lenses in 2022 was $360 from 
independent optical retailers and prescribers compared to just $183 
from online eyewear sellers.\81\ For many consumers, the convenience of 
being able to shop at the same location that they have their exam makes 
it worthwhile to buy glasses from their prescriber, even if they are 
more expensive. Many consumers also find it advantageous to try on 
glasses in person and have an expert tell them, based on their 
prescription and physical characteristics, the pros and cons of 
particular eyewear.\82\ In-person optical dispensaries can also perform 
precise facial measurements to provide a more personalized fit.\83\ 
Buying from one's prescriber can also make it simpler to have glasses 
adjusted post-purchase, if necessary.\84\ As discussed infra, however, 
some consumers buy eyeglasses from their prescriber because they feel 
pressured or obligated to, or are unaware that they can take their 
prescription and shop elsewhere for glasses.

Final Rule Pertaining to the Automatic-Prescription-Release Provision

A. Separation of Examination and Dispensing

    Section 456.2(a) of the Eyeglass Rule provides that it is an unfair 
act or practice for a prescriber to fail to provide to the patient one 
copy of the patient's prescription immediately after

[[Page 60747]]

the eye examination is completed. This provision allows, however, that 
a prescriber may refuse to give the patient a copy of the patient's 
prescription until the patient has paid for the eye examination, but 
only if that prescriber would have required immediate payment from that 
patient had the eye examination revealed that no ophthalmic goods were 
required.\85\ Sections 456.2(b) and (c) prohibit prescribers from 
imposing conditions for patients to receive eye examinations and 
prescriptions. Section 456.2(b) provides that it is an unfair act or 
practice for a prescriber to condition the availability of an eye 
examination on a requirement that the patient agree to purchase any 
ophthalmic goods from the prescriber. Section 456.2(c) provides that it 
is an unfair act or practice for a prescriber to charge any fee in 
addition to the examination fee as a condition for releasing the 
prescription to the patient. Section 456.2(d) provides that it is an 
unfair act or practice for a prescriber to waive or disclaim prescriber 
liability for the accuracy of the eye examination or the accuracy of 
the ophthalmic goods and services dispensed by another seller.
    These provisions, often referred to as the automatic-prescription-
release requirement (also referred to as the required ``separation of 
examination and dispensing''),\86\ were intended to make it clear that 
the purchase of eyeglasses is separate and distinct from the act of 
obtaining an eye exam, and to ensure consumers have possession of their 
ophthalmic prescriptions so they are able to ``price shop'' for 
eyeglasses.\87\ Absent physical possession of their prescriptions, 
consumers do not have the ability--and in some cases, the knowledge--to 
buy eyeglasses wherever they want. Consequently, there is less 
comparison-shopping, and less incentive for eyeglass sellers to 
advertise or compete with each other on price or service.\88\
1. Comments and Evidence Regarding the Automatic-Prescription-Release 
Provision
    In response to the Commission's NPRM, and during and after the 
Eyeglass Rule workshop, numerous commenters addressed the Rule's 
automatic-prescription-release provision, weighing in on whether (a) 
prescribers comply with the requirement and consumers receive their 
prescriptions, and (b) compliance is still necessary and beneficial for 
consumers.
a. Prescriber Compliance With Automatic Release, and Consumer Receipt 
of Their Prescriptions
    Several commenters stated that even though the automatic-release 
provision has been in effect for decades, prescribers still do not 
adhere to this requirement, and thus consumers often do not receive a 
copy of their prescription. Longtime eyewear consumer and ER workshop 
panelist Felecia Neilly, for instance, recounted how she has visited 
various eye doctors at least 50 times over the course of her life, and 
yet has rarely been handed her prescription without having to request 
it.\89\ ``It just always felt like there was a reluctance [on the part 
of the prescriber] in getting the complete information needed to fill 
the prescription, always,'' commented Neilly, adding that if the Rule 
has been in effect since the '70s, it should be automatic.\90\ Neilly 
added that even when she did request her prescription, she did not 
always receive the complete copy, thus making it a challenge for her to 
purchase eyewear.\91\
    Likewise, the National Association of Retail Optical Companies 
(``NAROC''),\92\ a trade association comprised of retail optical 
companies with co-located eye care services (such as LensCrafters, 
Costco Optical, and Walmart Vision Center), submitted a comment 
stating, ``We have no evidence to contradict the [previous Commission] 
finding that prescribers' failure to automatically provide customers 
with prescriptions at the completion of an eye exam--held to be an 
unfair act or practice when the Eyeglass Rule was enacted--remains 
prevalent, and millions of Americans every year are not receiving their 
eyeglass prescriptions as required by law.'' \93\ One Michigan 
optometrist, Dr. David Durkee, commented that ``the far majority of my 
colleagues do not engage in such practices [automatic release of 
prescriptions] out of fear of losing [retail] business.'' \94\
    Other members of the ophthalmic community, on the other hand, 
typically felt that compliance with the automatic-prescription-release 
provision is routine and common practice. Workshop panelist Dr. Jeffrey 
Michaels, a Virginia optometrist, commented, ``I think that the 
automatic compliance with this [prescription release] is so ingrained 
in optometrists and ophthalmologists that it's just a normal part of 
their day.'' \95\ He noted that in his optometric office, 100% of 
prescriptions are automatically uploaded to a patient portal ``the very 
second the prescription is finalized.'' \96\ The American Academy of 
Ophthalmology (``AAO'') volunteered that ophthalmology practices ``have 
a tremendous track record of compliance with existing prescription 
release requirements,'' \97\ and the Opticians Association of America 
(``OAA'') and American Optometric Association both noted that online 
eyeglass sales have been steadily increasing year over year, which they 
believe indicates that consumers have copies of their 
prescriptions.\98\
    The American Optometric Association also pointed to the fact that, 
over the past five years, there had been fewer than fifty prescribers 
warned by the FTC for potential violations of the Eyeglass Rule (such 
as failure to release prescriptions).\99\ The dearth of complaints was 
also emphasized by other optometrists, such as Dr. Michaels,\100\ who 
said, ``Well, we heard that there were 30-some-odd letters [relating to 
complaints of non-compliance] out of 55,000 doctors who prescribe,'' 
and Dr. Scott Sanders, a Mississippi optometrist, who commented, ``The 
FTC is trying to fix something that is not broken . . . Prescriber 
compliance is 99.99999%.'' \101\ Additionally, the American Optometric 
Association cited a consumer survey, performed at its behest by NERA 
Economic Consulting, which purportedly found that only 3 of 1072 
eyeglass consumers polled mentioned a possible Eyeglass Rule automatic-
release compliance issue, and this, according to the American 
Optometric Association, indicates that non-compliance is not 
prevalent.\102\
    However, the NERA survey did not specifically address prescription-
release compliance,\103\ did not directly ask consumers whether they 
received their prescription from their prescriber, and did not ask 
consumers if they were aware of their right to their prescription.\104\ 
Rather, the survey focused on where consumers purchased their 
eyeglasses and contact lenses, and why they purchased from that 
particular location. When consumers were asked to select the reasons 
that they purchased from that location, none of the 17 options offered 
included the availability or unavailability of their prescription (such 
as ``Because my prescriber didn't give me my prescription.''). The only 
way for survey respondents to reference prescription availability or 
unavailability was when asked open-ended questions such as ``In your 
own words, why did you purchase glasses from [the location that you 
did]?'' and ``Why did you ONLY consider purchasing glasses from [the 
location that you did]?'' In response to these questions, three 
consumers volunteered that they either thought they were required to 
buy from their doctor, or

[[Page 60748]]

that they bought from their doctor because the prescriber would not 
provide them with a copy of their prescription.\105\ Since only three 
consumers mentioned the lack of prescription release, the American 
Optometric Association contends that noncompliance must not be an 
issue.\106\
    Though the NERA survey provides some insights discussed later in 
this document, the Commission does not find the survey to be probative 
as to whether prescribers are releasing prescriptions (either 
automatically or on request). The fact that only three consumers \107\ 
proactively mentioned that prescribers had not provided them with their 
prescriptions could, perhaps, suggest that prescribers typically 
comply, but cannot be accorded significant evidentiary weight since 
consumers were not actually asked whether they received their 
prescriptions.
    The Commission also notes, as it has repeatedly in the past, that 
the raw number of consumer complaints about prescriber non-compliance 
is an unreliable barometer of prescriber compliance. As discussed in 
some detail during the Contact Lens Rule review, the Commission's 
experience has shown that the vast majority of injured or impacted 
consumers do not typically register complaints with the government, and 
even fewer are likely to submit a complaint about an FTC rule violation 
such as a prescriber's failure to release their prescription.\108\ This 
is especially true when--as will be discussed later in this final 
rule--evidence shows that many consumers remain unaware that they have 
an unconditional right to their prescription and should be receiving 
them automatically after each refractive exam. As workshop panelist 
Neilly commented, the lack of consumer complaints may correlate to the 
lack of knowledge about the prescription-release requirement ``because 
people don't even know there's an Eyeglass Rule.'' \109\ And even if 
consumers are aware that they have a right to their prescription and 
should have received it, they might not know to whom to complain in 
instances when it wasn't given to them.
    Apart from the NERA survey, none of the commenters to the NPRM or 
Eyeglass Rule workshop supplied new or updated empirical evidence. The 
extensive evidentiary record, however, includes two previously 
submitted surveys that shed light on the percentage of patients that do 
or do not receive their prescriptions. A survey conducted on behalf of 
Warby Parker by the polling firm SurveyMonkey reported that, of 
consumers who had purchased eyeglasses within the last three years, 47% 
of those who saw optometrists and 31% of those who visited 
ophthalmologists were not automatically provided with a physical copy 
of their eyeglass prescription.\110\ The survey also found that 14% of 
consumers had to pay their prescriber for a copy of their prescription 
when they requested a copy at a later time.\111\
    Another survey--conducted on behalf of 1-800 CONTACTS by the 
polling firm Survey Sampling International (``SSI'')--found that only 
34% of eyeglass wearers automatically received their prescriptions on 
the day of their office visit, with another 19% receiving it during 
their visit, but only after asking for it.\112\ According to the SSI 
survey, some consumers were able to obtain their prescription at a 
later point by returning to their prescriber's office, but 39% of 
consumers never received their prescription at all.\113\
    It is important to note that these surveys reveal more than simply 
that many prescribers fail to always comply with the automatic-release 
requirement. The surveys reveal that, even if prescribers will provide 
prescriptions when asked, a significant percentage of consumers leave 
their prescriber's office without their prescriptions. Which means 
that, for the next year or two (until their next eye exam), those 
consumers might be unable to shop for eyeglasses at an alternative 
location without having to contact their prescriber and ask for their 
prescription (and possibly have to pay for it). Although it is possible 
for other eyeglass sellers to call prescribers' offices and request 
patient prescriptions, this can lead to delays, and--in sharp contrast 
to the Contact Lens Rule--there is no legal requirement under the 
Eyeglass Rule that prescribers comply with requests to verify patient 
eyeglass prescriptions to third-party sellers.
    The two surveys cited herein have been criticized by optometrists 
and the American Optometric Association, which contend the Commission 
should disregard their results because the surveys were submitted by 
retail competitors with a financial stake in the outcome of the 
rulemaking,\114\ and were submitted as part of the FTC's Contact Lens 
Rule review, and the markets and patient experiences for eyeglasses and 
contact lenses are not the same.\115\ The American Optometric 
Association cited to NERA's survey and comment for the premise that 
``Commission conclusions and decisions regarding regulation in the 
contact lenses market cannot be presumed to apply to the eyeglasses 
market.'' \116\ As evidence of this dissimilarity, AOA has pointed to 
the NERA survey finding that eyeglass users are more likely than 
contact lens users to buy their corrective eyewear from someone other 
than their prescriber.\117\ AOA also noted that because contact lens 
fittings are not always complete in office due to patients taking home 
trial lenses to test, surveys of contact lens users may produce 
imperfect results in that consumers may report that they didn't receive 
their prescriptions at the end of their exam when, in fact, their 
contact lens fittings hadn't been finalized and so they weren't 
actually entitled to receive their prescriptions at that point.\118\
    With respect to AOA's first argument, the Commission acknowledges 
that both Warby Parker and 1-800 CONTACTS have a financial interest in 
the outcome of the Rulemaking. The Commission recognizes, however, that 
nearly all commenters have some form of interest in the outcome. And 
thus, as a general practice, the Commission does not simply disregard 
data or opinions submitted by interested parties. Rather, the 
Commission takes into account the financial interests of submitting 
parties, but also, when possible, examines the underlying data and 
methodology submitted to gauge a survey's usefulness, and considers 
factors such as how many people are queried, how the questions are 
phrased, and whether the surveys are conducted in-house (by the 
interested parties themselves) or by independent and established third-
party polling firms. Lastly, the Commission recognizes that all surveys 
are likely to have some methodological limitations, and thus the 
Commission will often decide not to treat any single survey as 
controlling or dispositive. The Commission is also aware, however, that 
multiple surveys conducted by different sources at different times with 
similar results tend to bolster the credibility of each individual 
survey.\119\ In this case, the surveys submitted by Warby Parker and 1-
800 CONTACTS are not flawless or immune to criticism, but were 
performed by reputable third-party polling firms and appear 
sufficiently reliable based on an examination of their questions and 
methodology.
    As for AOA's assertion that the two surveys were submitted during 
the Contact Lens Rule review and thus are not relevant to this Eyeglass 
Rule review, the Commission cannot concur. The contention that the 
SurveyMonkey survey was submitted during the Contact Lens Rule review 
is incorrect. While the Survey Monkey data was referenced during the 
Contact Lens Rule review, it was submitted in response to

[[Page 60749]]

the Commission's Eyeglass Rule Advance Notice of Proposed Rulemaking in 
2015 and was a survey of eyeglass wearers.\120\ As for the SSI survey, 
that was indeed included as part of a submission during the Contact 
Lens Rule review, but that particular survey polled both contact lens 
users and eyeglass users about their experiences with prescription 
release, and distinguished between the two in its results. The SSI 
results cited above--showing that approximately only 34% of eyeglass 
wearers automatically received their prescriptions following their 
refractive eye exam, and 39% did not receive their prescription at 
all--are results solely of eyeglass users' experiences.\121\ Any impact 
or effect caused by a dissimilarity in eyeglass and contact lens 
markets or experiences would not apply.\122\ Thus, criticism that these 
surveys do not reflect the appropriate target group or take into 
account differences between eyeglass and contact lens users is 
misdirected, and these surveys merit the Commission's full 
consideration.
    Moreover, the Commission cannot agree that other surveys detailing 
how contact lens users have not received their prescriptions do not 
have relevance in the context of the Eyeglass Rule. As noted above, 
there are, admittedly, differences in the examination and prescription 
processes for eyeglasses and contact lenses,\123\ but the mandatory 
prescription-release requirements are similar, and there is little 
evidence to indicate that prescribers release eyeglass prescriptions in 
dramatically different numbers than they release contact lens 
prescriptions. And while the NERA survey indicates that contact lens 
users are less likely than eyeglass wearers to purchase from someone 
other than their prescriber, this has little or no bearing on whether 
consumers are receiving their prescriptions from their prescriber 
(although it may have some bearing on whether automatic release is 
necessary or beneficial, as discussed below).
    The Commission therefore views the five additional consumer surveys 
submitted and considered during the CLR review--which found that 
between 21 and 34% of contact lens users did not receive their 
prescriptions when they were supposed to--as additional indications 
that prescriber compliance with prescription release, and overall 
consumer receipt of their prescriptions (whether contact lens 
prescription or eyeglass prescription), is sub-optimal.\124\
    Furthermore, the Commission notes, as it did in the CLR final rule, 
that despite multiple opportunities and requests for comment since 
2015, the Commission has yet to locate or receive any reliable 
consumer-survey data rebutting or contradicting the prescription-
release data in the record for either contact lens users or eyeglass 
wearers, or establishing, other than anecdotally, that consumers 
consistently receive their prescriptions from prescribers as they are 
supposed to under the applicable FTC rule.\125\ Based on the evidence 
in the record, it is thus the conclusion of the Commission that tens of 
millions of American consumers in need of corrective vision wear are 
not receiving their eyeglass prescriptions after visiting their 
prescriber each year.\126\
b. Whether the Automatic-Release Provision is Still Necessary and 
Beneficial for Consumers
    Having determined that prescriber compliance with the Rule's 
automatic-release provision is deficient, and that many eyeglass 
consumers do not receive their prescriptions, the Commission next 
considers the impact of this deficiency, and whether such failure 
remains an unfair act or practice in need of remedial action, as 
originally determined by the FTC when it formulated the Rule.\127\ 
Again, opinions on the need for, and benefit from, automatic 
prescription release, varied significantly in the comments received by 
the Commission. NAROC, for instance, opined that the automatic-release 
requirement--when complied with--provides a substantial benefit to 
consumers as it enables comparative shopping, and added there is ``no 
evidence to support a conclusion that the automatic release provision 
is no longer needed; to the contrary, the substantial expansion of 
consumer choice in recent years is strong evidence that this 
requirement has helped consumers and that it is more necessary than 
ever.'' \128\ In a subsequent comment, the organization added, ``There 
is widespread agreement that the Commission should continue the 
`automatic-prescription-release requirement' for eyeglasses,'' but 
evidence demonstrates that not all consumers are aware they should 
receive their prescription automatically, and some prescribers are not 
providing it.\129\ Wallace Lovejoy from NAROC opined during the 
workshop that, while some people have their mind made up before they go 
to the eye doctor, and want to get an exam and buy glasses at the same 
time and place, ``there's a significant number of people who get an eye 
exam and wait to shop and go somewhere else. It's useful to have the 
prescription released and I would agree that the automatic release 
seems to make the most sense.'' \130\
    Some other commenters endorsed this view. 1-800 CONTACTS, for 
example, stated, ``automatic prescription release is critical to 
promoting consumer choice and competition in the market for 
prescription eyewear,'' and ``prescribers are unlikely to comply with 
their automatic release obligations absent a credible threat of 
enforcement and fines. Prescribers have a strong financial incentive to 
withhold a prescription to discourage comparison shopping and pressure 
patients to purchase lenses inhouse.'' \131\ One anonymous commenter 
submitted, ``Being able to have a prescription in your hands as soon as 
your examination is done would be very beneficial to a lot of people 
for many reasons. This would allow people to shop for different 
resources for their lenses and find the best price for them. It 
shouldn't be a hassle for someone to get their prescription . . .'' 
\132\ Likewise, Sara Brown, from the advocacy organization Prevent 
Blindness, stated during the workshop, ``I think not having [automatic 
release] would make a major impact on patient access.'' \133\ She noted 
that millions of Americans have difficulty affording eyewear, and not 
having information that makes it easier for them to comparison-shop 
would be detrimental.\134\
    On the other hand, some commenters felt that, irrespective of 
whether prescribers automatically release prescriptions, prescribers no 
longer withhold prescriptions if directly asked for them. Dr. Arlan 
Aceto, a Connecticut Professor of Ophthalmic Design and Dispensing, for 
example, said during the workshop that he and his optician colleagues 
have not had a problem obtaining prescriptions from prescribers in 
instances where the patients failed to bring them,\135\ and panelist 
Dr. Artis Beatty, a North Carolina optometrist, commented that 
oftentimes patients are issued a prescription but fail to have it on 
hand when they need it.\136\ These comments suggest there may be less 
need for, and consequently less benefit from, the automatic-release 
requirement.
    The most extensive criticism of the automatic-release requirement 
came from workshop panelist and NERA consultant Dr. Andrew 
Stivers,\137\ who submitted a survey and lengthy comment that 
challenged the underlying basis for the requirement, noting, ``It's not 
just how much compliance, it's how impactful that compliance or lack of 
compliance is on consumers.'' \138\ According to Dr. Stivers, the 
relevant issue is whether, and how much, consumers have their eyeglass-
shopping options curtailed by failure of

[[Page 60750]]

prescribers to automatically provide patients with their prescriptions, 
since some consumers would not have shopped elsewhere even if they had 
received their prescriptions, and some consumers might have been 
offered their prescription and declined.\139\
    Dr. Stivers argued that the Rule's automatic-release provision was 
meant to address a lack of competition resulting from market conditions 
that do not exist in today's ``information rich, dynamic market,'' and 
thus the Commission should reexamine whether automatic release still 
benefits consumers in light of two fundamental changes that have 
occurred in the market.\140\ First, said Dr. Stivers, mass 
merchandisers and wholesale clubs have ``transformed'' the eyeglass 
shopping experience, and second, internet search and shopping has 
created a new, competitive channel for eyewear.\141\ The original 
rule's finding of unfairness, according to Dr. Stivers, rested on a 
context of advertising restrictions [of eyeglass sellers], State 
restraints on trade, limited shopping options for consumers, and overt 
prescription-withholding behavior by prescribers, that rarely exists 
today.\142\ Therefore, he contended, the Commission's ``determination 
of unfairness from 40 years ago cannot be presumed to apply today and 
thus there is no rationale or basis for new regulation in the 
prescription eyeglass market.'' \143\ Furthermore, Dr. Stivers 
explained, ``Today, consumers can choose to shop before getting an 
exam, which increases incentives to provide information and increases 
competition in ways that the Commission of 1978 could not imagine,'' 
\144\ and this change has made automatic release less likely to 
generate substantial benefit. And absent such benefits, per Dr. 
Stivers, lack of compliance with automatic release cannot be the basis 
for a determination of unfairness, or the proposed changes to the 
Rule.\145\
    As evidence of the altered market and changed consumer behavior, 
both Dr. Stivers and the American Optometric Association pointed to the 
NERA survey, which found, among other things: that consumers have 
numerous options for eyeglass purchases; that one in three eyeglass 
purchasers consider alternatives to where they ultimately purchase; 
that consumers purchase glasses from alternative channels such as 
retail chains and online stores more than 50% of the time; that 
consumers choose purchasing locations for a variety of reasons 
(including price, service, familiarity, location), with convenience 
valued over all others; and that eyeglass purchasers are more likely 
than contact lens users to know about and consider alternative 
purchasing channels.\146\ According to the American Optometric 
Association, these results demonstrate that consumers are aware of, and 
utilize, their eyeglass-purchasing options, and that there is a ``well-
functioning and competitive market for eyeglasses,\147\ thus calling 
into question the ``underlying premise that more must be done to 
encourage competition and choice in the eyeglass market.'' \148\ The 
AOA further quoted Dr. Stivers' NERA report for the premise that the 
survey results ``do not support or uncover any systemic market failures 
requiring additional rulemaking that would benefit consumers.'' \149\
2. Analysis of Evidence Regarding Failure To Release Prescriptions
    Having considered the evidence in the record--including the written 
submissions and workshop comments, empirical surveys of prescription-
release and consumer knowledge, ongoing and historical patterns of 
consumer complaints and anecdotal reports, and other relevant evidence 
submitted during the CLR review (and the Commission's determinations in 
that regard), along with the industry's long-documented history of 
failing to release prescriptions in order to capture consumer eyewear 
purchases in-house--in context of the intent, purpose, and history of 
the Eyeglass Rule, the Commission finds that, regardless of the 
increased information and availability of purchasing alternatives in 
today's eyeglass marketplace, it remains an unfair act or practice for 
prescribers to fail to release a prescription to consumers. The 
practice denies consumers the ability to effectively use the 
information available, and continues to result in substantial economic 
loss and lost opportunity costs due to an impaired ability to 
comparison-shop for eyeglasses. The Commission finds that such conduct 
remains pervasive, is likely to cause consumers substantial injury, is 
not outweighed by countervailing benefits that flow from such conduct, 
and cannot reasonably be avoided by a substantial number of consumers.
    The Commission does not dispute that mass merchandisers, wholesale 
clubs, and internet search and shopping have dramatically altered the 
overall retail landscape for eyeglass shopping. But these changes 
relate primarily to aspects of eyeglass shopping that occur once a 
consumer already has a prescription in hand. The initial experience of 
having an eye exam and obtaining a prescription remains much the same 
as it was when the Rule was created in that a consumer still has to be 
examined by an optometrist or ophthalmologist in order to obtain a 
prescription with which to buy eyeglasses. While Dr. Stivers has 
suggested that consumer emphasis on convenience when deciding where to 
buy glasses suggests they ``likely consider both where to get an exam 
and where to shop for glasses ahead of time for an efficient shopping 
experience,'' \150\ the NERA survey does not reveal to what extent this 
pre-exam shopping occurs, and Dr. Stivers acknowledged that he was 
unaware of any survey evidence establishing that many consumers 
comparison-shop before choosing their eyecare provider.\151\ The 
Commission is not aware of any empirical evidence showing whether pre-
exam shopping is prevalent, nor--even if it is--whether that means 
consumers no longer want or need a copy of their prescriptions. It also 
would not aid consumers who are hesitant to ask for their prescription, 
or feel pressured to buy glasses from their prescriber--whom they may 
view as a respected medical ``authority figure'' \152\--even if 
consumers' pre-exam intention was to take their prescription and buy 
glasses elsewhere. Furthermore, even if consumers decide pre-
examination that they want to buy glasses from their prescriber, and 
thus do not need a copy of their prescription, they could still be 
harmed by a prescriber's failure to release their prescription if, at a 
later date, those consumers want to purchase additional or replacement 
eyeglasses, and lack a copy of their prescription. In addition, as Dr. 
Michaels noted during the workshop, many consumers go in for an eye 
exam every year without any intention of buying glasses,\153\ only to 
learn during their exam that they now need vision correction, or that 
their vision correction has changed.
    Dr. Stivers is correct in that not all consumers necessarily 
benefit from receiving a copy of their prescription. Some consumers 
prefer buying glasses from their prescriber for convenience, or trust 
the expertise of their prescriber's staff to help fit them with the 
most appropriate eyewear. Some consumers simply favor the prescriber's 
frame options. But in trying to calculate how much consumer eyeglass-
shopping options are, or are not, curtailed by the failure to receive 
their prescriptions, the Commission faces a dilemma in that consumer 
decisions and preferences with respect to buying eyeglasses are 
impacted by the fact that so many consumers are not given a copy of 
their

[[Page 60751]]

prescription. Widespread lack of automatic prescription-release renders 
it difficult, if not impossible, to determine what percentage of 
consumers opted to buy glasses from their prescriber because they 
favored the prescriber's convenience, selection, and expertise, and 
what percentage opted to buy from their prescriber because they did not 
have a copy of their prescription, did not feel comfortable asking for 
one, or did not even know that they could. In sum, it is unlikely that 
consumers' current conduct and preferences regarding where they 
purchase eyeglasses can fully establish how much is or is not to be 
gained from improving compliance with the Rule's automatic-
prescription-release requirement because current consumer conduct and 
preferences are colored (and perhaps unfairly influenced) by current 
prescriber non-compliance with automatic prescription release.\154\
    Ultimately, it is the Commission's view that, regardless of the 
widespread availability of information and alternative opportunities to 
buy eyeglasses, not possessing a prescription continues to impede 
consumer options and comparison-shopping for eyeglasses. By many 
accounts, the Eyeglass Rule, and the removal of State restrictions, 
have played a major role in significantly altering and improving the 
information and alternatives available to eyeglass consumers.\155\ But 
possession of the prescription remains the key that unlocks the door to 
this altered and improved marketplace. As workshop panelist Lovejoy 
commented, ``[t]he ability to advertise doesn't matter if you don't get 
a copy of your prescription.'' \156\ The Commission noted this when 
promulgating the Eyeglass I Rule, declaring that the injury arising 
from failure to release prescriptions is clear in that consumers are 
denied ``the ability to effectively use available information, and 
inhibit the functioning of the competitive market model,'' and 
therefore, the failure to release prescriptions immediately after the 
eye examination is completed is, in and of itself, an unfair act or 
practice.\157\ This holds true irrespective of other changes and 
improvements in the eyeglass marketplace.
    Furthermore, it remains evident that many consumers are still not 
fully knowledgeable about their unconditional right to their 
prescriptions, and thus their ability to avoid or self-remedy harm 
arising from not possessing their prescriptions. While prescribers have 
often asserted that consumers are well-aware of their purchasing 
options,\158\ the Commission continues to receive communications 
evidencing that some consumers do not even realize they are entitled to 
their prescriptions.\159\ As workshop panelist Brown noted, ``there was 
a question that was [asked] earlier about why don't patients ask for 
this information? Because they don't know.'' \160\
    Indeed, some surveys have found that consumer awareness of 
prescription rights remains less than ideal. According to a 2015 
survey--performed on behalf of 1-800 CONTACTS--49% of prescription 
eyeglass wearers are not aware that they have a right to receive their 
eyeglass prescription, and 51% are not aware that their eye exam 
provider cannot charge for their eyeglass prescription.\161\ Multiple 
consumer surveys reviewed during the Contact Lens Rule review reinforce 
this by showing that a high percentage of contact lens users (46 to 
60%, according to submitted data) still do not realize they are 
entitled to receive their contact lens prescription,\162\ and it is 
probable that many of these consumers are also unaware they are 
entitled to their eyeglass prescription. The percentages of consumers 
unaware of their rights have been found to be even higher for 
traditionally underserved groups such as African Americans and 
Hispanics,\163\ and due to less English language proficiency, non-
native speakers may also be less likely to speak up and request their 
prescription--even if they know they can--if it is not automatically 
provided by their prescriber. There are also significant numbers of 
consumers each year who are new to the need for corrective eyewear, and 
thus have little experience with eye examinations, including whether 
they should receive a copy of their prescription. Therefore, the 
Commission concludes that while the NERA survey may suggest that some 
percentage of consumers is now aware of their option to obtain 
eyeglasses from a source other than their prescriber, the number of 
consumers fully informed of their prescription rights, and of their 
ability to take their prescription and shop elsewhere, remains sub-
optimal.
    Furthermore, as noted previously, the Commission is also aware that 
some consumers know they have the right to their prescription but may 
feel pressure to purchase from their prescriber, or feel uncomfortable 
asking for their prescriptions since it signals to the prescriber that 
they plan to purchase eyewear at a different location.\164\ Consumers 
often like and respect their prescribers, and are hesitant to do 
something that might be perceived as disloyal.\165\ Other consumers may 
be reluctant to acknowledge to their prescriber that they are cost-
conscious and have concerns about their ability to afford eyewear at 
the price charged by their prescriber.\166\
    After considering all of the evidence, the Commission concludes 
that when prescribers do not release prescriptions, it still harms 
consumers and puts them at a disadvantage in the marketplace, and thus 
continues to require remedial regulation.

B. The Remedy for Failure To Release Prescriptions Remains the 
Automatic-Release Requirement

    In fashioning a remedy for an unfair act or practice, the 
Commission has wide latitude, and need only show a ``reasonable 
relation'' between the unfair act or practice and the remedy.\167\ 
When, in the past, the Commission has considered how to remedy failure 
to release, it evaluated a variety of options, including, among other 
things, release-upon-request, offer-to-release, and increased signage 
and consumer education, and yet the Commission repeatedly determined 
that the most effective remedy is to require automatic release of 
prescriptions regardless of whether a consumer requests one following 
an examination. The Commission still finds this to be true and 
concludes that automatic release as a remedial measure continues to 
have a reasonable relationship to the unfair act or practice of 
withholding prescriptions. The Commission continues to find that 
automatic release remains the optimal remedy for prescribers' failure 
to release prescriptions because absent the requirement: (1) even more 
doctors would not always provide patients with their prescriptions, as 
demonstrated by surveys indicating that they often do not presently, 
even though required to do so; (2) large numbers of patients would not 
ask for their prescriptions due to a lack of awareness of their 
unconditional right to their prescription; (3) some patients would be 
reluctant to ask for their prescriptions (particularly underserved 
groups); and (4) release-upon-request would inappropriately place the 
burden on the consumer. Release-upon-request would also be difficult 
for the Commission to enforce because, absent documentary evidence, it 
would likely turn into a debate as to whether a patient did or did not 
ask for their prescription.
    While the Commission concludes that automatic prescription release 
remains the best remedy for the unfair practice of failure to release, 
it is also evident from the record that the remedy has not fulfilled 
its potential. The remedy has been in effect for over forty years, and 
yet a significant number of consumers are still not receiving their

[[Page 60752]]

prescriptions. The Commission therefore turns next to examine ways to 
improve the automatic-release remedy via amendments and clarifications 
to the Rule.

C. Commission Determination To Update the Rule To Clarify Requirements 
for Prescription Release

    One prescription-release issue that is periodically brought to the 
attention of the Commission relates to the timing of the Rule's 
required automatic prescription release--i.e., at what point that 
release must occur during a patient's office visit to their prescriber. 
The Rule, as presently written, states that it must occur ``immediately 
after'' the eye examination is completed, but that a prescriber may 
withhold the prescription until the patient has paid for the 
examination if the prescriber also requires immediate payment from 
patients for whom the examination revealed that no ophthalmic goods 
were required.\168\ The words ``immediately after,'' however, have not 
previously been discussed or clarified in detail, and some non-
prescribing eyewear sellers have raised concerns that prescribers who 
also sell eyewear have a tendency to lead patients into the prescriber-
owned optical dispensaries and offer to sell them eyeglasses 
immediately following an examination and before providing their 
patients with their prescriptions.\169\ Some prescribers and optometric 
consultants even recommend such an approach as a way of increasing 
customer ``capture rate.'' \170\ When this occurs, the prescription 
copy is only released to the patient after they have already shopped 
for eyeglasses, when they are checking out and paying their total bill 
(a bill that would include the cost of the examination, as well as the 
cost for new glasses).
    As noted during the Eyeglass Rule workshop, the Commission believes 
that prescribers holding onto a prescription until after they have 
already made an eyeglass sale runs contrary to both the letter and 
purpose of the Rule.\171\ The letter of the Rule is clear. The 
prescriber must provide the prescription ``immediately after the eye 
examination is completed.'' \172\ The policy of the Rule, as it relates 
to the timing of prescription release, is also clear in several ways. 
First, the regulatory history makes evident that two of the 
foundational purposes of the Rule have been to (a) separate the eye 
examination from the purchase of eyeglasses, and (b) ensure that 
consumers have possession of their ophthalmic prescriptions so they are 
able to comparison-shop for glasses.\173\ The singular fact that 
eyeglass prescribers sell what they prescribe \174\ (a practice that 
some members of Congress have called an ``inherent conflict of 
interest'') \175\ already blurs the distinction between eye examination 
and the purchase of eyeglasses, and when a prescriber offers to sell 
consumers glasses before releasing their prescriptions, it blurs that 
distinction even further.
    Additionally, as noted at the time the Commission first created the 
Rule, the prescription itself is ``the means by which consumers can 
comparison shop.'' \176\ Absent a prescription in hand, (whether that 
be physically in hand, or digitally uploaded to a patient portal and 
readily accessible to the consumer), consumers might not even realize 
they have an option to comparison-shop for their glasses. They may be 
confused, or misled, into thinking that the examination and purchase of 
eyeglasses are part of a unitary, or ``total vision care'' process, a 
once-common practice in the ophthalmic community in which the sale of 
eyeglasses was tied to the examination, and by scheduling an eye exam, 
a patient was essentially committing to purchase eyewear (if they 
needed it) from the same location at which they were examined.\177\
    While there is nothing inherently wrong with consumers buying 
eyewear from the prescriber who conducted their refractive examination, 
and there may be benefits to it,\178\ the Eyeglass Rule was created 
because the Commission determined it was an unfair practice when 
consumers did not at least have the option to buy glasses from someone 
other than their prescriber. The Commission believes it is problematic 
if patients are confused about whether they have, or do not have, the 
option to separate the examination process from the commercial purchase 
of eyeglasses. And even if patients recognize that by coming for an 
examination they are not committing to buy glasses from their 
prescriber, they may feel pressure to do so, a pressure heightened by 
the fact that until they possess a copy of their prescription, they 
cannot shop at any other locations.
    Lastly, the practice of not providing prescriptions until after the 
patient has selected eyeglasses can lead consumers to believe that they 
are receiving their prescription because it comes with the eyeglasses, 
or to believe that what they are paying for is their prescription copy, 
when, in fact, they are paying for their examination, and the 
prescription copy is free per the Rule. The Commission periodically 
receives complaints from consumers who believe they were charged for 
their prescription when, in actuality, consumers were charged for their 
examination, but the confusion arose because the prescriptions were 
only handed over after the consumers paid.\179\
    Ultimately, of course, the consumer is free to buy eyeglasses from 
their prescriber. Many consumers prefer to do so,\180\ and the 
Commission has no interest in preventing this. But to fully realize the 
intent and purpose of the Rule, consumers must have the unfettered 
option to buy from wherever they choose, and must not be confused or 
misled about their unconditional prescription rights, and whether their 
examination is connected to the purchase of glasses. To achieve this, 
consumers must have the prescription in their possession--whether 
physically or digitally--as soon as the prescription is finalized and 
before they are offered eyeglasses for sale.
    For this reason, the Commission is revising Sec.  456.2 to clarify 
that the prescription must be provided after the refractive eye 
examination is completed ``and before offering to sell the patient 
ophthalmic goods.'' This does not mean that a patient is not permitted 
to walk through a prescriber's eyeglass dispensary, or browse available 
eyeglass frames, before receiving a copy of their prescription. Nor 
does it cancel the Rule provision that a prescriber may make consumers 
pay for their exam before releasing their prescriptions, so long as 
that prescriber would have required immediate payment from the patient 
had the examination revealed that no ophthalmic goods were 
required.\181\ But it does mean that if a prescriber (or the 
prescriber's staff) is ready and willing to sell that patient 
eyeglasses, the prescriber must release a copy of the prescription to 
the patient before moving forward with any aspect of the sale. If the 
prescription is released electronically (with the patient's consent), 
it must be uploaded to a patient portal or transmitted to the patient 
via email or text, and thus fully accessible to the patient before that 
patient is offered an opportunity to purchase eyewear. It also means 
that if the prescriber makes a medical determination to not write and 
release a prescription to a patient,\182\ or withholds a prescription 
pending payment by the patient for the examination, the prescriber may 
not offer to sell that patient eyeglasses at that time.\183\ The 
prescriber may only offer to sell the patient eyeglasses after the 
prescription is released.\184\
    Furthermore, per the discussion above regarding automatic 
prescription release, the Commission still concludes--as it concluded 
multiple

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times in the past--that the burden of ensuring prescriptions are 
released must rest on the prescriber and not the patient.\185\ And thus 
automatic release must occur regardless of whether or not the 
prescription is requested by the patient. This has always been the 
intent of the Rule--and is already reflected in the existing 
requirement that the patient's prescription must be provided 
``immediately'' after the examination--but, unlike with the Contact 
Lens Rule, it has never been specifically stated in the Rule text. To 
ensure that is clear, and to bring the Eyeglass Rule prescription-
release requirement into concordance with that of the Contact Lens 
Rule, thereby simplifying compliance, the Commission is further 
revising Sec.  456.2 to clarify that the prescription must be provided 
``whether or not the prescription is requested by the patient.'' This 
does not mean that a prescriber must force the prescription on a 
patient who does not want a copy. The patient is always free to refuse 
a copy, in which case the prescriber should merely note that in their 
files. But prescribers and their staff must at least attempt to give 
the patient a copy of the prescription, rather than merely offer to 
provide a copy, or just wait and see if the patient asks for it.
    Neither of these clarifications alter the burden on prescribers, 
they merely make clearer what is already required by the Rule, and what 
should already be occurring in practice.

III. Final Rule Pertaining to Affirmative Consent to Digital Delivery 
of Eyeglass Prescriptions

A. Digital Delivery Option in the NPRM and the Basis for Such Amendment

    As discussed above, Sec.  456.2(a) of the Eyeglass Rule provides 
that it is an unfair act or practice for a prescriber to fail to 
provide to the patient one copy of the patient's prescription 
immediately after the eye examination is completed. The Rule, as 
currently codified, does not expressly permit electronic delivery of 
prescriptions as a means for automatic prescription release. In the 
NPRM, the Commission considered technological advances, such as the 
proliferation of patient portals, along with prescriber-to-patient 
communication via email or text, that could facilitate the transmission 
of the prescription to the patient once the eye exam is completed, and 
thereby enhance prescription portability.\186\ The Commission opined 
that permitting electronic delivery in certain circumstances could 
provide benefits to consumers, and proposed amending the Rule to permit 
such delivery after the prescriber obtains the patient's verifiable 
affirmative consent.\187\
    To ensure that patients are able to make an informed choice about 
whether to agree to electronic delivery, the proposal required that the 
prescriber identify the particular delivery method to be used, such as 
portal, text, or email, and the prescription would need to be provided 
in a digital format that can be accessed, downloaded, and printed by 
the patient.\188\ This could enable patients to have easier access to 
and use of a prescription, reduce requests for additional copies and 
calls from sellers to verify a prescription, and potentially lower 
costs while providing flexibility for prescribers and patients. To aid 
Commission enforcement efforts to monitor compliance with the Rule, the 
Commission proposed that prescribers be required to keep a record or 
evidence of a patient's affirmative consent for a period of not less 
than three years.\189\
    This proposed amendment to the Eyeglass Rule mirrored a change made 
to the CLR in 2020, allowing prescribers to satisfy the CLR's 
automatic-release requirement by providing the patient with a digital 
copy of his or her contact lens prescription in lieu of a paper copy, 
provided the prescriber first identified the specific method of 
delivery to be used and obtained the patient's verifiable affirmative 
consent to this method of delivery.\190\ In the CLR SNPRM, the 
Commission noted that providing patients with an electronic copy of 
their prescriptions could enable patients to share prescriptions more 
easily with sellers when purchasing eyewear, and this in turn could 
potentially reduce the number of patient and seller requests for 
verification or additional copies of the prescription. To enhance 
portability, the Commission noted that electronic delivery methods 
should allow patients to download, save, and print the 
prescription.\191\

B. Comments on the NPRM and Discussion at the Workshop Regarding the 
Proposal To Permit Digital Delivery of the Eyeglass Prescription With 
Patient's Affirmative Consent

    In addition to seeking general comments on the benefits and burdens 
of this proposed change, the Commission invited public comment on 
whether prescribers would choose to satisfy the automatic-prescription-
release requirement through electronic delivery if permitted by the 
Rule, and whether patient portals, emails, or text messages would be 
feasible methods for the provision of digital prescription copies. The 
Commission also asked what other technologies are available that could 
be implemented to improve prescription portability, and thereby 
increase benefits and decrease burdens related to prescription release.
1. Comments About the Benefits and Burdens of the Proposed Affirmative 
Consent to Digital Delivery Provision
    The Commission received generally positive feedback on the proposed 
digital delivery provision, with commenters noting that it would allow 
the Rule to keep pace with technology and it would help patients 
understand their rights under the Rule.\192\ The AOA opined that this 
would be a ``commonsense update'' that would ``ensure [ ] that the 
FTC's regulatory language is keeping pace with updates in technology.'' 
\193\ NAROC suggested that the ``impact of allowing a prescriber to 
release the [prescription] in digital form will be to increase patient 
understanding of their rights, because every instance of receipt of a 
digital copy of the prescription will require affirmative consent to 
such delivery and will help build an expectation on the part of 
consumers that they are entitled to the prescription.'' \194\
    Other commenters who objected generally to the burden of other 
proposed changes, including the proposed confirmation requirement, 
pointed to the widespread transition to electronic health records 
(``EHRs'') or electronic medical records (``EMRs'') and argued in favor 
of prescription availability via a portal as being wholly sufficient to 
address the FTC's concerns about prescription release, and ensure 
patient access to their prescription.\195\ Another commenter, an 
ophthalmic technician, expressed concerns over the added recordkeeping 
burden from the proposed confirmation requirement, noting that their 
practice already has a record of the prescription on file for the 
patient and that most EHRs track when prescriptions are printed 
out.\196\
    Although having a prescription available on file upon request 
(either in a paper record or accessible through an online portal) would 
not satisfy the automatic-prescription-release requirement, the 
Commission considered the proliferation of patient portals and EHR 
systems in the NPRM, and discussed both the potential benefits 
available to consumers, prescribers, and sellers through the use of 
such systems, as well as the possible drawbacks. On the benefit side, a 
patient using a portal could have direct access to a current, exact 
copy of the eyeglass prescription, reducing the chance of errors caused 
by an inaccurate or expired prescription, and the need for follow-up 
corrections by prescribers.\197\ The use of health information

[[Page 60754]]

technologies, such as patient portals, could also reduce costs for 
prescribers, patients, and sellers by making it easier and more 
efficient for patients to obtain and share eyeglass prescriptions, and 
by reducing the number of requests placed on prescribers to verify 
prescription information or provide duplicate copies of prescriptions. 
In addition, it is likely that patient portals do not raise the same 
privacy concerns expressed by some prescribers about sharing patient 
prescription information with third parties because patient portals can 
enable the secure sharing of such information directly with the 
patients themselves, who may then provide the prescription to the 
third-party seller.\198\
    The Commission is aware, however, of potential drawbacks in relying 
on electronic records exclusively for prescription delivery. In the 
recent CLR rulemaking, commenters expressed concerns that: (1) online 
portals are not widely used; (2) patients may not always be aware of 
the portal or may have difficulty accessing or printing documents 
online; and (3) some prescribers and patients prefer paper copies.\199\
    Recent data shows that the number of prescribers offering patients 
access to their health information through an EHR system or patient 
portal has increased significantly. A survey from 2022 found that 
nearly 3 out of 5 U.S. adults reported they were offered and accessed 
their online medical record or patient portal, which was a 50% increase 
since 2020.\200\ Patients also increased their use of apps to access 
online medical records, and patients using apps to view their online 
medical records accessed them more frequently than those who used only 
a web-based method.\201\ Available information suggests, however, that 
disparities still exist in the availability and use of patient portals 
among some populations, including older patients.\202\ A variety of 
factors may influence the limited portal use in such populations, 
including lack of access to technology and personal preference, and 
some groups (including Black and Hispanic individuals) may be less 
likely to report being offered access to a portal in the first place, 
suggesting a need for improvement in provider communication and clinic 
practices.\203\ In addition, of those patients who access their online 
medical records through an app or web-based patient portal, relatively 
low numbers are downloading and transmitting their health information, 
which ``suggests a need for further education of both individuals and 
providers on these features,'' according to the Office of the National 
Coordinator for Health Information Technology.\204\
2. Comments in Favor of Allowing Prescribers to Choose Whether To Offer 
Digital Delivery of Prescriptions
    A number of commenters supported making the decision to offer 
digital prescription delivery--either at all or using particular 
delivery methods--a voluntary one on the part of prescribers.\205\ For 
example, NAROC approved of not requiring prescribers to provide 
prescriptions electronically, but noted that some prescribers may 
already be complying with the CLR prescription-release requirement 
through digital prescription delivery and, for these prescribers, 
permitting compliance with the Eyeglass Rule in the same manner would 
create efficiencies for prescribers' offices.\206\ Some commenters also 
suggested that compliance with the automatic-release requirement is 
made easier by the digital delivery option due to the ease of emailing 
either the prescription itself or a link to a portal on which the 
prescription is available.\207\
    One anonymous commenter questioned whether portals would need to be 
configured to require a patient signature whenever a patient accesses 
the portal to print a prescription.\208\ Workshop panelist Dr. Michael 
Repka, Medical Director for Governmental Affairs at the AAO, described 
an intricate process his office undertakes to attempt to obtain a 
signature of prescription-receipt from a patient who accesses their 
contact lens prescription via a portal.\209\ The Commission, however, 
notes that this represents a misunderstanding of the CLR's digital-
prescription-delivery provision, which specifically removes the 
signature-requirement when prescriptions are digitally delivered, and 
likewise, confirmation signatures would not be required when 
prescriptions are delivered digitally under the amended Eyeglass Rule. 
Using a digital delivery method to comply with Sec.  456.2 would 
relieve the prescriber of having to collect a signature from the 
patient confirming their receipt of the prescription.\210\ Under the 
new Sec.  456.4(a)(1)(ii), prescribers using a digital delivery method 
would not need to request that the patient sign a separate statement 
confirming receipt of the prescription.\211\ Instead, prescribers would 
need merely to retain evidence that the prescription was sent, 
received, or made accessible, downloadable, and printable, which 
commenters have acknowledged EHRs generally are configured to do.\212\ 
Similarly, an emailed or texted prescription should create its own 
record of transmission, and therefore involve minimal burden to the 
prescriber.
    Other commenters shared that the existence of electronic health 
records in a medical practice does not automatically result in a 
patient having access to their prescription on a portal,\213\ and that 
some prescribers may be using simplified websites to provide 
prescription delivery without giving a patient full access to all of 
their exam information, in order to make access simpler for 
patients.\214\ Some prescribers may be hesitant to offer EHR systems 
because of concerns about cost, functionality, and data security.\215\ 
For these reasons, the Commission believes it is important to allow 
prescribers the choice of whether to offer a digital delivery method to 
comply with the automatic-release requirement in the Eyeglass Rule, 
rather than mandating it.\216\ The final rule neither compels 
prescribers to offer prescription-release by an electronic method nor 
requires that patients accept their prescription by electronic method 
when offered by the prescriber.
3. Comments Regarding Giving Patients a True Choice as to How To Have 
Their Prescription Delivered
    Some commenters expressed concerns that not all patients may 
benefit from electronic access to their prescription, both as a result 
of limitations in broadband capabilities and due to differences in 
patient needs and health literacy that might affect patients' ability 
to access their prescriptions online.\217\ Commenters asserted that 
patients must retain the ability to receive a paper copy of their 
prescription.\218\ The challenges in educating patients on how to 
access their prescription on a portal were also noted by Workshop 
panelist Dr. Stephen Montaquila, a Rhode Island optometrist, who 
acknowledged that some patients prefer a paper copy.\219\
    Other commenters described their experience with patients 
frequently losing or forgetting their prescription when going to order 
glasses. The commenters pointed to the remedy of having the 
prescription available on the portal, or noted that the patient could 
request a duplicate copy of the prescription or the seller could call 
to verify a prescription with the prescriber, and argued that these 
solutions should resolve concerns over prescription access and 
portability.\220\ The Eyeglass Rule does not, however, require 
prescribers to respond to seller verification requests or provide 
duplicate copies of prescriptions, as is required by the CLR. The 
Commission also remains concerned about the

[[Page 60755]]

ongoing lack of understanding and limitations in patient access to 
portals or other health technology, and concludes that requiring all 
patients agree to digital delivery is not appropriate at this 
time.\221\

C. Additional Discussion and Commission Determination Regarding the 
Affirmative Consent to Digital Delivery

1. Final Rule Determination To Add Option for Digital Delivery of 
Eyeglass Prescriptions
    The Commission agrees with the comments in favor of permitting, but 
not requiring, electronic delivery of the eyeglass prescription, 
provided consumers are informed about, and consent to, the delivery 
method. Based on its review of the record, the Commission is hereby 
modifying the Rule to require that prescribers provide patients with a 
copy of their prescription either (a) on paper or (b) after obtaining 
verifiable affirmative consent to digital delivery, in a digital format 
that can be accessed, downloaded, and printed by the patient. Obtaining 
such consent to digital delivery will require the prescriber to 
identify the specific method or methods of electronic delivery that 
will be used, and collect the patient's affirmative consent to the 
specified delivery method in a way that is verifiable, i.e., can later 
be confirmed, such as through a signed consent form or electronic 
approval (as discussed below). Prescribers must then keep evidence of a 
patient's affirmative consent for a period of not less than three 
years. Patients who decline to consent, for any reason, must be given a 
paper copy of their prescription. Likewise prescribers who prefer to 
provide paper copies to their patients need not offer an electronic 
option.
    Importantly, providing the option for digital delivery does not 
alter the prescriber's obligation to automatically provide the eyeglass 
prescription regardless of whether a patient requests it, but merely 
the method by which the patient will receive the prescription. It also 
does not impact the timing of prescription delivery. Whether the 
patient consents to digital delivery or opts for a paper copy of the 
prescription, prescribers must provide the prescription immediately 
after the eye examination is completed. As discussed above, it is 
critical that the patient be in receipt of their prescription before a 
prescriber offers to sell them eyeglasses, so as to ensure the 
separation of examination and dispensing under Sec.  456.2, and to 
ensure that patients are able to freely comparison-shop for 
eyeglasses.\222\ Accordingly, if a patient consents to the prescriber 
emailing or texting the prescription, or placing it on a portal, this 
method of delivery must take place at the end of the examination, and 
before the prescriber or prescriber's staff attempts to sell the 
patient eyeglasses.
    The digital delivery option includes a recordkeeping provision, 
but, as the Commission concluded in the CLR final rule, the burden of 
retaining a record of patient consent should be minimal, ``since 
prescribers who opt for electronic delivery of prescriptions will, in 
all likelihood, obtain and/or store such consent electronically.'' 
\223\ As detailed below, the Commission is modifying the proposed rule 
text to expressly recognize that consent to digital delivery can be 
obtained either on paper or in a digital format. In any case, obtaining 
and storing a record of patient consent should not take longer than 
obtaining and storing a patient's confirmation of prescription 
release,\224\ and prescribers who use digital delivery to provide the 
prescription would not need to request that the patient acknowledge 
receipt of the prescription by signing a separate confirmation 
statement. Finally, offering a prescription in a digital format would 
be an option for prescribers, but is not mandatory, so prescribers can 
choose not to offer electronic delivery of prescriptions if they find 
the recordkeeping provision overly burdensome.\225\
    One related issue raised by some commenters is whether prescribers 
could obtain a patient's consent to digital delivery a single time 
rather than at every visit, and only need to obtain consent again if 
the prescriber changes their digital-delivery policy, a practice 
permitted by the Department of Health and Human Services with regard to 
its Notice of Privacy Practices signed-acknowledgement 
requirement.\226\ Dr. Montaquila, for one, noted that allowing 
prescribers to obtain consent just once, when the patient first visits 
a practice, would lessen the Rule's burden for prescribers and yet 
still allow for the patient to be educated, opt-in knowingly, and have 
the opportunity to withdraw consent at a later time.\227\
    The Commission notes that the Rule, as proposed in the NPRM and 
hereby adopted, does not specify that the verifiable affirmative 
consent must be obtained at every appointment. Instead, it requires the 
prescriber to provide the prescription on paper or ``in a digital 
format that can be accessed, downloaded, and printed by the patient, 
after obtaining verifiable affirmative consent, pursuant to Sec.  
456.3.'' The Commission clarifies that if the prescriber identifies the 
digital method that will be used for prescription delivery and allows 
the patient to choose whether to consent to that delivery method 
(rather than making it the default), then allowing patients to sign an 
authorization just once would satisfy the Rule's requirements. But as 
noted by the commenters, if the prescriber changes their digital 
delivery policies (for example, by switching from email delivery of 
prescriptions to access on a portal), they would need to re-obtain the 
patient's digital delivery consent. Additionally, prescribers should 
allow a patient to revoke consent at any time.
    Further, the Commission believes that prescribers could use a 
single document to obtain verifiable consent to digital delivery of 
both contact lens and eyeglass prescriptions so long as it is clear to 
consumers that they are consenting to digital delivery for both. 
Ensuring that patients are aware of where to locate their 
prescriptions, and how to access them, should be a priority for 
prescribers, so regular re-education on these points is 
appropriate.\228\
    Furthermore, Sec.  456.3(c) requires that prescribers maintain 
records or evidence of a patient's affirmative consent for a period of 
not less than three years. It is important to note that if a prescriber 
intends to provide digital delivery to a patient for more than three 
years following that patient's signed consent, they should not dispose 
of the consent record after three years. Rather, the prescriber should 
retain the patient's signed consent for as long as the prescriber 
relies on it to authorize digital delivery of the prescription, plus 
another three years.\229\
2. Final Rule Moves Requirement for Obtaining Patient's Verifiable 
Affirmative Consent for Digital Delivery to a New Section and Out of 
Definitions
    In the NPRM, the Commission proposed adding the digital delivery 
provision to the Rule as a new definition of the phrase ``provide to 
the patient one copy'' in Sec.  456.1.\230\ This definition would have 
stated both the option for the prescriber to offer the patient a 
digital copy of their prescription, and the requirements for obtaining 
verifiable affirmative consent to the digital delivery and maintaining 
a record or evidence of the patient's affirmative consent for a period 
of not less than three years. Adding this definition to the Rule would 
have mirrored the Commission's amendment of the CLR in 2020 to provide 
a similar

[[Page 60756]]

option for digital prescription delivery.\231\
    Upon further consideration, the Commission has decided to move the 
digital delivery provision out of the definitions section and into 
Sec.  456.2. By moving this language to Sec.  456.2, the Commission 
seeks to ensure prescribers do not overlook the requirements for 
providing prescriptions digitally. Moving the digital delivery 
provision to this section may also make the requirement more noticeable 
and understandable to consumers. The FTC is also cognizant that the 
preferred drafting practice for regulations is to set out requirements 
in the body of the rule, rather than in the definitions.\232\
    Accordingly, the Commission is amending Sec.  456.2(a), 
``Separation of examination and dispensing,'' to state that the 
automatic prescription release shall be provided on paper; or in a 
digital format that can be accessed, downloaded, and printed by the 
patient, after obtaining verifiable affirmative consent, pursuant to 
Sec.  456.3. The Commission is then adding a new Sec.  456.3 to the 
Rule titled, ``Verifiable affirmative consent to providing the 
prescription in a digital format.'' \233\ New Sec.  456.3 sets out the 
remainder of the text proposed in the NPRM as Sec.  456.1(h)(2). It 
requires that when a prescription copy is provided in a digital format, 
the prescriber shall inform the patient of the specific method(s) of 
electronic delivery that will be used; obtain, on paper or in a digital 
format, the patient's verifiable affirmative consent to receive a 
digital copy through the identified method or methods; and maintain 
records or evidence of a patient's affirmative consent for a period of 
not less than three years, as specified in the new Sec.  456.3.
    Since the digital delivery provision, as adopted herein as Sec.  
456.3, was clearly proposed as Sec.  456.1(h)(2) in the NPRM, moving 
the requirement to a new section in the Rule complies with the 
rulemaking requirements of both the Administrative Procedure Act and 
the FTC Act, while ensuring that regulated entities and the general 
public do not overlook the requirements because they were included in 
the definitions.\234\ The Commission recognizes that the placement of 
the digital delivery provision in a new, dedicated section differs from 
the CLR, where it appears in the definitions. The requirements in each 
rule, however, are effectively the same. The Commission can amend the 
CLR during the next periodic rule review to mirror the Eyeglass Rule 
and, in the meantime, can provide clarity to prescribers through 
guidance materials.
3. Final Rule Adds Explicit Recognition of the Ability To Obtain 
Affirmative Consent on Paper or in a Digital Format
    In this final rule, the Commission is amending the Rule to 
explicitly permit prescribers to obtain a patient's verifiable 
affirmative consent either ``on paper or in a digital format.'' This 
clarification comes in response to comments relating to permitting 
digital consent.
    Participants at the workshop discussed that some EHR companies 
haven't updated their systems in light of the new CLR requirements to 
allow prescribers to collect signatures electronically, which would 
reduce the record-keeping burden.\235\ Nevertheless, commenters 
suggested that the Rule should expressly permit prescribers to obtain 
patient signatures digitally or on paper.\236\ For example, regarding 
the confirmation of prescription release, NAROC wrote, ``[t]he 
Commission may want to specifically allow for the signature to be an 
electronic signature by means of either a handwritten signature input 
onto an electronic signature pad or a handwritten signature input on a 
display screen with a stylus device. . . . While it is not clear to us 
how many optometry or ophthalmology offices use electronic signatures 
today, this clarification may pave the way for more offices to adopt 
this method of collecting a signature, making the confirmation process 
more efficient and less reliant on paper receipts in the future.'' 
\237\ Dr. Montaquila acknowledged that some practices are already using 
electronic methods to capture patient signatures required by the 
CLR.\238\
    Throughout the process of updating the CLR to permit digital 
prescription delivery and require confirmation of prescription release, 
the Commission acknowledged that prescribers may obtain a patient's 
signature either on paper or digitally. In the NPRM for the Contact 
Lens Rule review, the Commission proposed, ``[t]he acknowledgment form 
shall be in a format that allows either conventional or electronic 
signatures. Prescribers may maintain copies of the acknowledgment forms 
in paper or electronically.'' \239\ In the SNPRM for the CLR, the 
Commission stated, ``[t]he 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.'' \240\ Similarly, when proposing changes to the 
Eyeglass Rule in its NPRM, the Commission noted the ``recordkeeping 
burden could be reduced to the extent that prescribers have adopted 
electronic medical record systems, especially those where patient 
signatures can be recorded electronically and inputted automatically 
into the electronic record.'' \241\
    The Commission finds the Rule is improved by explicitly permitting 
prescribers to obtain a patient's verifiable affirmative consent either 
``on paper or in a digital format.'' Accordingly, Sec. Sec.  456.3 and 
456.4, setting forth the requirement for obtaining a patient signature 
confirming prescription receipt, allow prescribers to meet the 
requirements of these provisions by obtaining the patients signature 
either ``on paper or in a digital format.'' \242\ This will resolve 
prescriber confusion regarding the need to print out digital forms and 
collect wet signatures that might then need to be scanned and stored 
electronically in an EHR system. Alleviating prescriber 
misunderstanding regarding signature collection should help reduce 
waste and facilitate faster, more efficient Rule compliance.\243\
4. Final Rule Clarifies That Digital Delivery Methods Identified in 
Affirmative Consent Request Must in Fact Be Used
    The Commission recently sent cease and desist letters to 
prescribers of contact lens prescriptions and eyeglass prescriptions in 
response to consumer complaints that the prescribers did not release 
their prescriptions at the end of the contact lens fitting or eye 
examination, or otherwise violated the CLR or Eyeglass Rule.\244\ As 
discussed at the workshop, in subsequent communications with letter 
recipients, Commission staff obtained samples of forms some prescribers 
were using to comply with the CLR consent-to-digital-delivery and 
confirmation-of-prescription-release requirements. Staff noted, 
``[w]e've seen forms where there's not a separate signature about 
digital consent. We've also seen forms where the information is 
included in an intake form among a lot of other information that the 
patient may not see. And in some cases, the specific method of 
electronic delivery is not necessarily identified. It may say, `We will 
provide you with your prescription digitally either by text, email, or 
portal.' '' \245\
    The Commission is concerned that patients cannot provide informed 
consent to digital delivery if prescribers do not identify the delivery 
method that will be used. Patients will not know where to locate their 
prescription if they are not told which delivery method the prescriber 
plans to use. This can result

[[Page 60757]]

in the patient effectively not receiving the prescription, as required 
by the Rule. Similarly, providing a disclosure about digital delivery 
as part of a long form containing unrelated information, such as 
privacy practices and payment policies, and then requesting one 
signature at the end of the form might not be an effective way of 
obtaining the ``verifiable affirmative consent'' required by the Rule. 
Dr. Beatty noted that decoupling information during intake related to 
patient consent may be appropriate to ensure patients are understanding 
and agreeing to digital delivery.\246\
    In addition, providing a copy of the prescription electronically by 
default while notifying patients that they can request a paper copy if 
they want one undermines the automatic-prescription-release requirement 
by converting it to a release-upon-request model that the Commission 
has rejected.\247\ As an example, one of the sample forms shown at the 
workshop stated, ``I acknowledge the [Prescription Access] policy and 
note I can (i) access my eyeglass and contact lens prescriptions 
digitally at [website redacted] or (ii) obtain a paper copy at any time 
as well.'' \248\ This language essentially transforms it into a notice 
of digital delivery rather than a true patient consent to digital 
delivery. In satisfying the Eyeglass Rule's automatic-prescription-
release requirement, the patient must be given an actual choice to 
select an identified electronic delivery method or to receive the 
prescription on paper automatically. Prescribers are free to also place 
prescriptions on a portal, but this action would not satisfy the 
requirements of Sec.  456.2 if the patient did not opt-in to the 
digital delivery option.
    To provide clarity to prescribers, the final rule, in Sec.  
456.3(a), states that the prescriber shall, ``identify to the patient 
the specific method or methods of electronic delivery that will be 
used,'' rather than ``to be used,'' as was proposed.\249\ The digital 
delivery method or methods the prescriber identifies to the patient 
when seeking consent should be the method the prescriber actually uses. 
It would not be appropriate, for example, for a consent form to state, 
``I authorize my eye doctor to provide me with a digital copy of my 
prescription via email, text, and/or the secure online patient portal 
at the completion of my contact lens fitting and/or refractive eye 
examination,'' unless the prescriber did in fact deliver the 
prescription using all of the referenced methods.

IV. Final Rule Pertaining to Confirmation of Prescription Release

A. Proposed Confirmation Requirement in the NPRM and the Basis for Such 
Proposal

    After considering the evidence discussed in sections I and II, 
supra, including comments submitted in response to the ANPR, the 
Commission proposed in the NPRM to amend the Rule to add a 
confirmation-of-prescription-release requirement. In so doing, the 
Commission stated its belief that such confirmation would increase the 
number of patients who receive their prescriptions, inform patients of 
the Rule and of their right to their prescriptions, reduce the number 
of seller requests to prescribers for eyeglass prescriptions, improve 
the Commission's ability to monitor overall compliance and target 
enforcement actions, reduce evidentiary issues, complaints and disputes 
between prescribers and consumers, and bring the Eyeglass Rule into 
congruence with the confirmation-of-prescription-release requirements 
of the Contact Lens Rule.\250\
    As a result, in the NPRM, the Commission proposed a new Sec.  456.3 
\251\ to require that upon completion of a refractive eye examination, 
and after providing a copy of the prescription, the prescriber shall do 
one of the following:
    (i) Request that the patient acknowledge receipt of the 
prescription by signing a separate statement confirming receipt of the 
prescription;
    (ii) Request that the patient sign a prescriber-retained copy of a 
prescription that contains a statement confirming receipt of the 
prescription;
    (iii) Request that the patient sign a prescriber-retained copy of 
the sales receipt for the examination that contains a statement 
confirming receipt of the prescription; or
    (iv) 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.
    Proposed Sec.  456.3 further provided that if the prescriber elects 
to confirm prescription release via paragraphs (a)(i), (ii), or (iii), 
the prescriber may, but is not required to, use the statement, ``My eye 
care professional provided me with a copy of my prescription at the 
completion of my examination'' to satisfy the requirement. In the event 
the patient declines to sign a confirmation requested under paragraphs 
(a)(i), (ii), or (iii), the prescriber shall note the patient's refusal 
on the document and sign it. A prescriber shall maintain the records or 
evidence of confirmation for not less than three years. Such records or 
evidence shall be available for inspection by the Federal Trade 
Commission, its employees, and its representatives. The prescription 
confirmation requirements shall not apply to prescribers who do not 
have a direct or indirect financial interest in the sale of eye wear, 
including, but not limited to, through an association, affiliation, or 
co-location with an optical dispenser.'' \252\
    The Commission then sought public comment on the benefits and 
burdens of its confirmation-of-prescription-release proposal.\253\ The 
Commission also invited comment on whether the proposed change would 
affect Rule compliance, the Commission's ability to enforce the Rule, 
or patient's understanding of their rights under the Rule.\254\

B. Comments on the NPRM and Discussion at the Workshop Regarding 
Confirmation of Prescription Release

1. Comments in Favor of Confirmation-of-Prescription-Release Proposal
    The record contains numerous comments in support of the 
confirmation-of-prescription-release amendment, with these comments 
detailing the need for, and benefits of, the proposed amendment. 
Reasons given in support of the amendment include: that it will bring 
greater awareness of a consumer's right to their prescription, greater 
compliance with automatic prescription release,\255\ and a greater 
ability for the Commission to enforce the Rule; that the acknowledgment 
will serve as evidence of compliance for prescribers; and that benefits 
flow from having the Eyeglass Rule's confirmation requirement match 
that of the Contact Lens Rule. Other commenters generally support the 
Rule, but did not provide specific reasons for their support.\256\
    NAROC, calling the confirmation proposal needed and simple,\257\ 
stated that it would result in greater compliance and wider consumer 
understanding of their rights.\258\ In addition, according to NAROC, 
the proposal would allow all sellers in the market for corrective 
eyeglasses to participate. Specifically, NAROC stated support for 
requiring confirmation since ``evidence demonstrates that despite the 
many years that the [automatic prescription release] requirement has 
been in effect, not all consumers are aware that they should receive an 
eyeglass prescription without requesting it.'' \259\ Consumer Action, 
likewise,

[[Page 60758]]

called the confirmation proposal ``consumer-friendly'' and discussed it 
as a way to remedy a lack of compliance, a lack of consumers awareness 
of their automatic right to a copy of a prescription, a lack of 
competition, and a reduced ability to shop around for lower 
prices.\260\
    Other commenters reiterated that the confirmation proposal would 
increase compliance with automatic prescription release. The advocacy 
organization National Taxpayers Union supported requiring confirmation 
to ``strengthen the process of providing consumers with a copy of their 
eyeglass prescription,'' which will benefit consumers.\261\ 1-800 
CONTACTS stated the ``confirmation proposal will bolster prescription 
portability, promoting consumer choice and competition in the evolving 
market for prescription eyewear.'' \262\
    Commenters specifically spoke to the proposed amendment's ability 
to assist the Commission in enforcing the Rule's automatic-release 
requirement. 1-800 CONTACTS stated its desire for greater enforcement 
of the Rule and expressed disappointment that the Commission has only 
issued warning letters since enacting a similar requirement for the 
Contact Lens Rule in 2021.\263\ NAROC commented that both the 
confirmation of prescription release and the three-year recordkeeping 
requirement will make the Rule easier for the FTC to enforce. The 
organization stated that prescribers have a responsibility to provide 
evidence that the patient received a copy of the eyeglass prescription 
at the end of the exam, and that confirmations of prescription release 
are helpful to prescribers to show their compliance in instances when 
patient complaints of non-compliance are brought before them.\264\ At 
the workshop, Joseph Neville of NAROC added that, if the FTC was going 
to regularly enforce the Rule, the prescriber needs proof they actually 
complied, and the acknowledgment will serve that purpose.\265\ NAROC 
likened the confirmation proposal to prescribers asking their patients 
to acknowledge receipt of privacy practices, to give consent to certain 
treatments or procedures, and to allow providers to share protected 
health information in certain situations.\266\ According to NAROC, such 
acknowledgments benefit the prescriber by averting disputes as to what 
the patient agreed.
    At the workshop, Wallace Lovejoy opined that it is appropriate to 
encourage some sort of recordkeeping that the prescription was in fact 
delivered to the patient due to ``the unique nature of the market and a 
significant amount of financial interest on the part of prescribing and 
dispensing optometrists'' \267\ Indeed, NAROC commented that 
prescribers have a powerful incentive to improve the ``capture rate'' 
of in-office eyewear sales to their patients since they still make most 
of their revenue from selling the eyewear that they prescribe.\268\
    NAROC also stated that the significant benefits of the proposed 
confirmation would exceed the minimal burdens. Its comment stated that 
the ``amendments should not have significant or disproportionate impact 
on prescribers' costs'' and that its member experience and observation 
indicates that ``thousands of optometrists affiliated in co-location 
with NAROC member companies regularly comply with the current Eyeglass 
Rule and the Contact Lens Rule [which already contains a confirmation-
of-prescription-release requirement] with little added cost or other 
burden on the eye care practice.'' \269\ NAROC said it has not seen any 
credible evidence that the requirement is overly burdensome or will 
result in anything more than a trivial expense. In response to requests 
from their members for information as to whether the added effort of 
confirmations for contact lens prescriptions was a problem, they heard 
that compliance is occurring with little or no disruption or 
expense.\270\
    Pete Sepp, the president of the National Taxpayers Union, said he 
supports the Rule and the confirmation proposal, but is very cognizant 
of regulatory burdens imposed on prescribers. He said the key question 
for him is whether the extra burden the confirmation brings is a 
problem, or alternatively, whether the problem may derive rather from 
the overall burden from all regulations imposed on prescribers.\271\
    The National Taxpayers Union (NTU) suggested that the Commission 
may have underestimated the confirmation burden, particularly the 10-
second estimate for how long it takes for consumers to read and sign 
the confirmation statement.\272\ It also stated it was likely the 
burden would have a disproportionate impact on smaller, less 
sophisticated, prescribers who lack economies of scale and equipment, 
and thus merely averaging the burden cost among all of the nation's 
eyecare prescribers was an ``oversimplification.'' \273\ According to 
NTU's estimate, a ``modest optometry establishment'' performing 3,000 
examinations a year would--based on the Commission's NPRM estimates for 
time and labor--increase the paperwork burden by 167 hours and incur an 
additional labor compliance cost of $4,123, ``not an inconsiderable 
burden for a small establishment.'' \274\ Sepp of the NTU did suggest, 
however, that compliance with the confirmation-of-prescription-release 
proposal ``might not be quite as burdensome'' when comparing it to the 
overall regulatory burdens on prescribers, and that perhaps the real 
focus should be on reducing overall burdens that hamper small 
businesses.\275\
    One factor worth noting for the confirmation proposal, according to 
NAROC, is that having a similar confirmation requirement for the 
Eyeglass Rule, as already codified in the Contact Lens Rule, should 
lessen the additional incremental burden of the proposed amendment to 
the Eyeglass Rule, since most contact lens wearers also receive 
eyeglass prescriptions and should get them at the same time.\276\ NAROC 
also stated that the similar requirement for the Eyeglass Rule should 
ease issues with compliance and staff training.\277\
2. Comments Against the Confirmation-of-Prescription-Release Proposal
    Some commenters, largely prescribers and prescriber trade 
associations, were critical of the confirmation-of-prescription-release 
proposal, stating that existing strong compliance with the automatic-
prescription-release requirement of the Eyeglass Rule makes the 
proposed confirmation requirement unnecessary, and that the 
confirmation proposal is burdensome.\278\
    The American Optometric Association opposed the proposed 
confirmation requirement for a number of reasons. As noted above in the 
discussion regarding automatic-release compliance, the AOA asserts that 
the requirement is unnecessary because it disputes that there is any 
issue with prescription-release compliance.\279\ In addition, the AOA 
asserted that a confirmation requirement would not have a significant 
and meaningful impact on competition and choice and in support cited 
the (previously discussed) NERA survey for the propositions that: (1) 
three in five Americans do not believe that additional paperwork 
requirements in their doctor's offices would make them more aware of 
their rights; (2) nearly half indicated the amount of paperwork they 
currently do is overwhelming; (3) 41% indicated that the complexity of 
the paperwork is overwhelming; and (4) approximately 20% of those 
surveyed did not even remember the purpose of the paperwork they have 
to complete at a doctor's appointment.\280\ Based on these results, the 
AOA concluded that

[[Page 60759]]

``it is inaccurate to say that a new paperwork requirement for eyeglass 
prescriptions can lead to increased competition and choice.'' \281\
    Further, the AOA expressed concern that the confirmation 
requirement would have a disproportionate burden on small business, 
given the fact that many of its members have a small staff, high staff 
turnover, and face challenging economic pressures, including increased 
overhead and costs.\282\ In fact, according to AOA, the NERA survey 
data supports its position that the FTC ``significantly 
underestimated'' how long it takes to confirm prescription 
release.\283\ According to the AOA, a large percentage of its members 
report that it takes 30 seconds or more to obtain the patient's signed 
confirmation and ``[e]ssentially, doctors of optometry have reported 
that the time burden is at least 3 times the FTC's estimated burden.'' 
\284\ (emphasis in original). The AOA requested that the Commission 
reconsider whether there is an urgent need at this time for the 
confirmation-of-prescription-release amendment.\285\
    Individual prescribers share some of the same concerns voiced by 
the AOA. At least two commenters stated that the proposed confirmation 
is a burdensome solution to a problem that does not exist.\286\ A 
number of commenters, some of whom commented anonymously, stated that 
the confirmation is unnecessary, costly, intrusive, and would be time-
consuming and take away from patient care.\287\ Optometrist Dr. David 
Durkee suggested that adding the burden of another confirmation 
requirement would be counterproductive and likely just lead to more 
prescriber non-compliance.\288\ At the workshop, Dr. Michaels stated 
that there is a lot of time, effort, and discussion required when 
prescribers ask their patients to sign confirmations.\289\ Dr. 
Montaquila explained at the workshop that for contact lens 
prescriptions, it takes his ``very best staff about four minutes to 
complete the [confirmation and prescription release] process, from 
explaining why we're doing it to the patient, providing them with their 
prescription, making the copies, providing their prescription back to 
them, and ultimately storing it.'' \290\ He stated that the office 
devotes about 1.5 full time employees to all of the office's compliance 
issues and that adding more rules [to the Eyeglass Rule] will only 
increase costs to the practice.\291\ Dr. Montaquila also noted that the 
burden is recurring (as opposed to a one-time expense) since each time 
prescribers provide a prescription, a confirmation will be needed.\292\ 
Dr. Masoudi questioned whether multiple confirmations are needed when 
multiple prescriptions are provided, and claimed that that would also 
increase the burden of compliance.\293\
    The AAO also disagreed that the burden would be minimal, noting 
that it would particularly hit hard on small practices that may not 
utilize electronic health record systems.\294\ AAO further argued that, 
without better evidence of non-compliance, the confirmation-of-
prescription-release amendment should not be imposed, and asked the 
Commission to identify alternative mechanisms to address actions of 
noncompliant prescribers.\295\ Dr. Repka also noted at the workshop 
that he has not seen a benefit for either the prescriber or the 
consumer in the contact lens space since enactment of the confirmation 
requirement in the Contact Lens Rule.\296\
    Some commenters pointed to differences between the eyeglass and 
contact lens markets to support their position that the Eyeglass Rule 
should not contain the same confirmation requirement as exists in the 
Contact Lens Rule. Dr. Montaquila argued that there is a greater burden 
associated with the Eyeglass Rule proposal due to the greater volume of 
eyeglass wearers--165 million eyeglass wearers versus 45 million 
contact lens wearers.\297\ Dr. Repka pointed out that the average 
eyeglass wearer is much older than the average contact lens wearer and 
that the older population may be more easily concerned about multiple 
signature lines.\298\
3. Comments About the Exemption for Prescribers Who Do Not Have a 
Direct or Indirect Financial Interest in the Sale of Eyeglasses
    In the NPRM, the Commission proposed to exempt prescribers who do 
not have a direct or indirect financial interest in the sale of 
eyeglasses from the proposed signed confirmation-of-prescription-
release requirement.\299\ Direct or indirect interest in the sale of 
eyeglasses would include, but not be limited to, an association, 
affiliation, or co-location with prescription-eyewear sellers.\300\ The 
Commission requested input on the question, ``Aside from associations, 
affiliations, and co-locations with prescription-eyewear sellers, what 
other indirect financial interests exist in the sale of prescription 
eyewear that should disqualify a prescriber from the proposed 
exemption?'' \301\ There were no written comments in response to the 
NPRM or workshop on this point.\302\
    At the workshop, Joseph Neville floated the idea of applying the 
exemption more broadly. Specifically, he said that for the Contact Lens 
Rule, NAOO, the predecessor to NAROC, suggested that prescribers who 
were affiliated in a co-location situation should be exempt from the 
signed acknowledgment requirement.\303\ He explained that when an 
optical company leases space to a prescriber, the prescriber does not 
sell the eyeglasses, and thus, the exemption should apply. Yet, he 
acknowledged that the Commission previously rejected that position and 
in concluding his comments, he supported the Commission's proposal to 
limit the exemption to those who are solely involved in clinical and 
not connected in any way with sales.\304\
4. Comments About Alternatives to the Confirmation-of-Prescription-
Release Proposal
    As possible alternatives to the signed acknowledgement proposal, 
commenters at the ANPR stage recommended conspicuous signage regarding 
consumers' right to a copy of their prescription, or an eye care 
patients' bill of rights, notifying consumers of their rights under the 
Rule.\305\ Some commenters seemed to suggest that there is a greater 
need for the FTC or prescribers to educate consumers or to enforce the 
Rule as is, as opposed to amending the Rule to include a confirmation 
of prescription release.\306\ For instance, the AOA opposed the 
Commission's NPRM proposal, and asserted that the Commission should 
focus its energies on scrutinizing the sales of online retailers, and 
advising the public about ``risks'' arising from purchasing glasses 
online.\307\ Meanwhile optometrist David Durkee recommended that 
instead of adding the confirmation requirement, the Commission should 
increase enforcement through random audits, inspections, fines, and 
increased publicity about such penalties.\308\

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

1. Final Rule Determination To Amend the Rule To Require Confirmation 
of Prescription Release
    The Commission has carefully reviewed and analyzed all of the 
evidence in the record, including the 868 comments submitted in 
response to its ANPR, 27 comments submitted in response to its NPRM, 
the discussion at the 2023 Eyeglass Rule workshop, 20 comments after 
the workshop, and when appropriate, the record from the

[[Page 60760]]

Commission's recent review of the Contact Lens Rule. This record, in 
conjunction with the historical impetus for the Rule and the 
Commission's enforcement and oversight experience, has led to a 
Commission determination to amend the Rule to add a confirmation-of-
prescription-release requirement.
    The evidence demonstrates that the automatic-release requirement 
remains the optimal remedy for prescribers' continued failure to 
release prescriptions, and yet lack of compliance with the automatic-
release provision hampers the effectiveness of this remedy.\309\ The 
evidence also demonstrates that consumers lack an awareness of their 
rights to a copy of their eyeglass prescription, and thus may be unable 
to remedy a prescriber's failure to release prescriptions on their 
own.\310\ Having determined that it would be beneficial to increase 
compliance with, and awareness of, the automatic-release provision, the 
Commission has determined that the best way to achieve this goal is to 
amend the Rule to add a new requirement to the existing automatic-
release remedy. By modifying and improving the remedy for prescribers' 
failure to release a prescription, it will not only increase the number 
of patients who receive their prescriptions and learn of their right to 
possess their prescriptions, but will also: reduce the number of seller 
requests to prescribers for eyeglass prescriptions, improve the 
Commission's ability to monitor overall compliance and target 
enforcement actions, reduce evidentiary issues, complaints and disputes 
between prescribers and patients, and substantively bring the Eyeglass 
Rule into congruence with the Contact Lens Rule in terms of the 
confirmation-of-prescription-release requirement.
    This remedy also solves the ``evidentiary squabbles'' issue as to 
whether a prescriber complied in a specific instance, or complies 
routinely with prescription release. As explained in the NPRM, the 
absence of documentation often makes it difficult in an enforcement 
investigation to determine whether, in any particular case, a 
prescriber provided a patient with a prescription. The lack of 
documentation also makes it difficult to determine how many times, or 
how frequently, a particular noncompliant prescriber has violated the 
Rule.\311\ In fact, due in part to the difficulty of ascertaining 
whether a prescriber violated the Rule, the Commission has only brought 
one enforcement action against an eyeglass prescriber for failure to 
comply with the automatic prescription release.\312\ The confirmation-
of-prescription-release requirement will improve and simplify its 
ability to assess and verify compliance with the Rule's automatic 
prescription release requirement. It will also make it easier for 
prescribers to prove that they did, in fact, provide prescriptions to 
patients who claim otherwise.
a. Alternatives to Confirmation of Prescription Release Not Adopted
    The Commission is not adopting the alternative remedies proposed by 
some commenters. First, as explained above, no new comments or evidence 
was submitted following the NPRM regarding the proposal to require 
conspicuous signage in prescribers' offices stating consumers' rights 
to their prescriptions, and, likewise, no new comments or evidence 
submitted with respect to a consumer Bill of Rights.\313\ Since the 
Commission had previously decided, for the reasons outlined in the 
NPRM,\314\ not to adopt these measures, the Commission has no reason to 
revisit and alter its decision.
    For a number of reasons, the Commission also declines to adopt the 
proposal that the Commission focus on additional consumer education in 
lieu of adopting the signed confirmation of prescription release. 
First, relying on such an approach would improperly shift the burden of 
prescription-release compliance and enforcement to the consumer, an 
approach the Commission has repeatedly rejected in the past.\315\ 
Second, the Commission resolves that educating consumers at their 
appointment about their right to their prescription is more targeted 
and impactful than other methods of consumer education alone in which a 
consumer is not asked to read and provide a signature. Lastly, the 
AOA's suggestion in its NPRM comment to educate consumers about the 
potential risks from purchasing eyeglasses online would do nothing to 
increase prescription release. In fact, the suggestion appears 
unrelated to the issues under discussion in the NPRM or this final 
rule.
    Although the Commission declines commenters' suggestions that it 
rely on greater consumer education in lieu of a signed confirmation 
requirement, as discussed in section IV.B.4, supra, the Commission 
agrees there is a need to bolster its existing guidance on the Eyeglass 
Rule, as an added measure to inform consumers of their rights, and 
businesses of their obligations, under the Rule.
    As for the suggestion that the Commission increase enforcement of 
the existing automatic-release provision in lieu of adding a 
confirmation requirement, the Commission addressed this in the NPRM, 
noting that the Commission recognizes the need for increased 
enforcement, but that the absence of documentation often makes it 
difficult in an enforcement investigation to determine whether, in any 
particular case, a prescriber provided a patient with a 
prescription.\316\ The lack of documentation also makes it difficult to 
determine how many times, or how frequently, a particular noncompliant 
prescriber has violated the Rule. Instead, allegations and denials of 
non-compliance often become a matter of a patient's word against that 
of the prescriber, making violations difficult to prove.\317\
b. The Burdens of the Confirmation of Prescription Release Are Not 
Substantial
    The evidentiary record does not establish that the burden of the 
confirmation-of-prescription-release requirement will have a 
substantial financial impact on prescribers. Prescribers already comply 
with a similar requirement for contact lens prescriptions, and it 
should require a minimum of additional time, effort, and training to 
include eyeglass prescriptions. Some prescribers may already be getting 
patient confirmations for eyeglass prescriptions, since it does not 
make much sense to obtain confirmations for contact lenses but not for 
eyeglasses, and the patient confirmation provides the prescriber with 
tangible proof that they complied with the existing prescription-
release requirement. In its Paperwork Reduction Act (``PRA'') analysis, 
the Commission doubled the previously estimated time it takes for 
prescribers' offices to obtain a signed patient confirmation, and yet 
even doubled, it is still merely 20 seconds. In reality, it may even 
take less, and some industry estimates appear to be based on faulty 
presumptions.\318\ Furthermore, the ongoing transition to digital 
recordkeeping will continue to reduce the burden, both in terms of 
record preservation and obtaining patient signatures. The final rule's 
overall estimated financial burden for the confirmation-of-
prescription-release requirement of $38,389,993 amounts by one estimate 
to approximately $629 in additional annual administrative costs per eye 
care provider.\319\
    The Commission also does not find the AOA's paperwork survey, 
summarized in its comment, as compelling evidence for its position that 
``it is inaccurate to say that a new

[[Page 60761]]

paperwork requirement for eyeglass prescriptions can lead to increased 
competition and choice.'' \320\ A review of appendix A attached to its 
comment shows that the following survey question was asked of 1,063 
respondents: ``Thinking about your experience, both virtual and in-
person, with doctors in general, please select your level of agreement 
with the following statements.'' The statements included in the survey 
were: (1) ``I generally remember the purpose of the paperwork I 
complete at a doctor's appointment''; (2) ``The amount of paperwork I 
have to complete at a doctor's appointment is overwhelming''; (3) ``The 
complexity of the paperwork I have to complete at a doctor's 
appointment is overwhelming''; and (4) ``Having to sign more paperwork 
at a doctor's appointment would make me more aware of my patient's 
rights.'' The options provided to the respondents for each statement 
are: ``Completely agree,'' ``Somewhat agree,'' ``Neutral,'' ``Somewhat 
disagree,'' and ``Completely disagree.'' \321\
    These questions, and the extent to which consumers agree or 
disagree with them, may reveal the unsurprising fact that most people 
do not appreciate doing ``paperwork,'' but do not display anything of 
import related to this rulemaking. By asking generalized questions 
about ``paperwork''--a term with a negative connotation--and 
``patient's rights,'' without explaining to respondents the context or 
what rights they are referring to, the survey loses its informational 
value. It does not reveal what consumers think about a confirmation-of-
prescription-release requirement, about whether they would appreciate 
having a copy of their prescription, about whether they understand 
their right to their prescription, or even about their experiences with 
any particular documents provided to them by eye care prescribers.\322\
    Aside from the fact that these survey questions are too vague and 
generalized to serve as a gauge as to the usefulness of a confirmation-
of-prescription-release requirement, the survey questions may even 
indicate that some paperwork can serve a purpose. According to the 
survey, 62% of Americans respond that they generally remember the 
purpose of the paperwork they complete at a doctor's appointment, with 
another 19% remaining neutral on this question; and 40% agree with the 
statement, ``having to sign more paperwork at a doctor's appointment 
would make me more aware of my patient rights,'' with another 30% 
responding neutrally.\323\ While these percentages do not reveal 
anything about the confirmation-of-prescription-release requirement, 
they could, in fact, support the general position that many Americans 
do remember information from the paperwork they fill out at their 
doctors' offices, and that the paperwork can serve to make them 
somewhat more aware of their general rights. Of greater significance 
for this rulemaking, however, is the fact that the confirmation-of-
prescription-release requirement is not solely intended to educate 
consumers about their rights. While that is one purpose, the 
requirement is also intended to remind prescribers' offices to provide 
patients with their prescriptions, and to create a mechanism for 
prescription-release verification and enforcement. Therefore, the 
Commission finds that the signed confirmation of prescription release 
(a form of ``paperwork'') will increase prescriber compliance, and that 
will lead to increased competition that benefits consumers.
    The Commission also carefully considered information and comments 
on the record that question the Commission's estimate of time for 
confirming prescription release, including the separately conducted AOA 
survey of its members submitted in support of its statement that the 
FTC ``significantly underestimated'' the length of time it would take 
for prescribers to confirm prescription release. As discussed more 
fully in the Paperwork Reduction Act section (section VIII of this 
SBP), the Commission has decided to increase the estimated time to 
obtain a patient confirmation signature.\324\
    Although the Commission does not find the burdens of the 
confirmation of prescription release to be substantial, the Commission 
is sensitive to the concerns raised by the AOA and others regarding the 
burden on prescribers, many of whom are small businesses. In an attempt 
to minimize these burdens, the Rule provides prescribers with both 
digital and paper options for methods to comply,\325\ and provides one-
sentence sample language that prescribers can use when providing paper 
copies of prescriptions should they wish to use it. As for concerns 
that the burden is ongoing since each time a prescriber provides a 
prescription a confirmation is needed, the Commission notes that many 
prescribers may offer and consumers may accept a digital delivery of 
the prescription, and as previously discussed, may not need to ask for 
affirmative consent to digital delivery for every new visit.\326\ As 
for paper copies of prescriptions, over time consumers should become 
more familiar with the request for their signature to confirm 
prescription receipt and thus, the staff time to handle possible 
questions or to otherwise comply with the confirmation of prescription 
release should decrease.\327\ The Rule also has an exemption for those 
without a direct or indirect financial interest in the sale of 
eyeglasses. Moreover, this amendment aligns with the prescription 
release related provisions of the Contact Lens Rule, thereby reducing 
the confusion and complexity that might arise for consumers and 
prescribers from having different confirmation-of-prescription-release 
requirements for contact lens and eyeglass prescriptions. In addition, 
the marginal cost of the amendment to the Eyeglass Rule should be 
relatively low because the CLR already requires prescribers to obtain 
confirmation of prescription release and to maintain records of such. 
Some prescribers likely have forms and systems in place already, which 
may need only minor adjustments to accommodate confirmations for 
eyeglass prescriptions.\328\
c. Exemption for Prescribers Who Do Not Have a Direct or Indirect 
Financial Interest in the Sale of Eyeglasses
    The Commission also adopts without modification proposed Sec.  
456.3(c), which provides an exemption to the confirmation-of-
prescription-release requirements for prescribers who do not have a 
direct or indirect financial interest in the sale of eyeglasses.\329\ 
Direct or indirect financial interest in the sale of eyeglasses 
includes, but is not limited to, an association, affiliation, or co-
location with prescription-eyewear sellers.\330\ The Contact Lens Rule 
contains a parallel exemption.\331\ The purpose of such an exemption is 
to reduce the burden on prescribers who do not sell lenses, and 
therefore, have no incentive to withhold prescriptions.\332\ Although 
Joseph Neville of NAROC questioned whether co-location arrangements 
should be considered as having an interest in the sale of eyeglasses, 
the Commission finds that co-location arrangements could create a 
financial incentive for prescribers to withhold a prescription, and 
thus, should be required to comply with the confirmation requirement. 
If a prescriber has uncertainty as to whether the exemption applies, 
they should err on the side of caution by complying with the 
confirmation-of-prescription-release requirement.\333\ Since there was 
no opposition to the proposal relating to the exemption, the Commission 
adopts Sec.  456.3(c) as proposed.\334\

[[Page 60762]]

2. Comments About Options for Obtaining the Confirmation and Commission 
Determination
    The Eyeglass Rule NPRM proposed in Sec.  456.3(a) the same options 
to confirm prescription release of eyeglass prescriptions as the 
options available to confirm prescription release of contact lens 
prescriptions in the Contact Lens Rule. They consist of: (i) a signed 
statement confirming receipt of the prescription; (ii) a prescriber-
retained copy of a contact lens prescription that contains a statement 
confirming receipt of the prescription; (iii) a prescriber-retained 
copy of the receipt for the examination containing a statement 
confirming receipt of the prescription; and (iv) if a digital copy of 
the prescription was provided to the patient, retain evidence that the 
prescription was sent, received, or made accessible, downloadable and 
printable.\335\ Workshop participants discussed these options in the 
context of the Contact Lens Rule in order to recommend for or against 
their inclusion in the Eyeglass Rule's confirmation requirement.
a. Comments at the Eyeglass Rule Workshop
    At the workshop, Dr. Montaquila discussed the ``range of 
approaches'' prescribers use to comply with the CLR's confirmation-of-
prescription-release requirements and provided concrete examples of the 
way some of the options are currently in use. He called option 
(a)(1)(i), the signed statement option, a flexible option currently in 
use. But, he stated that, for some offices that have electronic health 
records, offices must print the prescription from the electronic health 
records systems, request a signature, scan or retain the prescription 
with the acknowledgment, and store the acknowledgment.\336\ He provided 
an example of a template form that he said is in use by many 
offices.\337\ This form, entitled ``Contact Lens Prescription Signed 
Acknowledgment Form'' is recommended by the AOA to its members and is 
in its ``Contact Lens Rule Compliance Toolkit.'' \338\ The form 
contains six paragraphs, with the first stating, ``Included below is 
important information to review prior to receiving your contact lens 
prescription.'' The middle three paragraphs consist of advice, 
attributed to the Centers for Disease Control and the Food and Drug 
Administration, on healthy contact lens wearing habits, and include 
recommendations such as ``Schedule a visit with your eye doctor at 
least once a year'' and ``Understand that eye infections that go 
untreated can lead to eye damage or even blindness,'' among others. The 
fifth paragraph presents five bullet points listing common symptoms of 
an eye infection, such as ``Irritated, red eyes,'' ``Light 
sensitivity,'' and ``Sudden blurry vision.'' The last paragraph, 
directly above a patient signature and date line, states, ``Sign below 
to acknowledge that you were provided with a copy of your contact lens 
prescription at the completion of your contact lens fitting.''
    As for proposed Sec.  456.3(a)(1)(ii), in which prescribers retain 
signed copies of contact lens prescriptions that contain a statement 
confirming receipt of the prescriptions, Dr. Montaquila stated that the 
AOA assists prescribers who use this option by providing carbon-copy 
prescription pads.\339\ With this method, the prescriber writes the 
prescription, the patient signs the confirmation statement on the 
prescription, and the patient and prescriber each retain a copy. Dr. 
Montaquila then implied that this paper option was less convenient or 
accurate because 88% of office-based physicians have transitioned to 
EHRs.\340\ According to Dr. Montaquila, some prescribers are 
handwriting prescriptions after generating a prescription in an 
electronic health record, and this duplication increases cost, time, 
and the possibility for errors.\341\ In support of his assertion about 
greater errors from handwritten prescriptions, he cited to a Weill 
Cornell Medical College study of drug prescriptions finding error rates 
in 30 per 100 written prescriptions versus seven per hundred in 
electronic prescriptions.\342\ He stated that some EHRs permit 
prescriptions containing statements of confirmation to be printed, but 
this creates a different problem because once it is signed by the 
patient, the office ``needs to take that prescription back, copy and 
perhaps scan it and then retain that for three years.'' \343\
    Section 456.3(a)(1)(iii) of the NPRM Eyeglass Rule confirmation 
proposal (and existing Contact Lens Rule confirmation requirement) 
allows prescribers to retain a signed statement confirming prescription 
receipt on a copy of the examination payment receipt. According to a 
2023 AOA survey of optometrists, about 15% of prescribers said they use 
this method,\344\ but Dr. Montaquila stated that he had not found that 
any of his colleagues had a payment system in place that would allow 
for the use of this method with respect to the confirmation of contact 
lens prescription release.\345\
    Dr. Montaquila also addressed the digital release option, proposed 
Sec.  456.3(a)(1)(iv), which allows a prescriber, with the patient's 
affirmative consent, to release the prescription digitally so long as 
they retain evidence that the prescription was sent, received, or made 
accessible, downloadable and printable. In discussing this option, he 
displayed a model consent form used by many practices for contact lens 
prescription release entitled ``prescription access notice policy 
statement.'' The model form states that access to prescriptions is 
available to patients digitally and that physical copies of 
prescriptions are available, and provides a place for a patient 
signature. He noted that the electronic prescription-release approach 
can take many forms depending on what's available to the practice, and 
that some forms default to the patient agreeing to receive the 
prescription digitally, with a paper version available upon 
request.\346\
b. Commission Determination Regarding Options for Obtaining the 
Confirmation
    The final rule, Sec.  456.4(a)(1), replaces the four options from 
the NPRM with two broader options in paragraphs (a)(1)(i) and (ii) that 
encompass the options proposed in the NPRM, but also ensure prescribers 
have flexibility and choice in how they obtain their confirmations. The 
first option, Sec.  456.4(a)(1)(i), covering instances where 
prescribers provide a paper copy of the prescription, provides that the 
prescriber must request that the patient acknowledge receipt of the 
prescription by signing a separate statement confirming receipt of the 
prescription. Section 456.4(a)(1)(i) adopts the proposed Sec.  
456.3(a)(1)(i) with modifications so that it encompasses the proposed 
Sec.  456.3(a)(1)(ii) (where a prescriber can retain a copy of a 
prescription that contains a signed statement confirming receipt of the 
prescription) and proposed Sec.  456.3(a)(1)(iii) (where a prescriber 
can retain a signed copy of the sales receipt for the examination that 
contains a statement confirming receipt of the prescription). The 
NPRM's proposed Sec.  456.3(a)(1)(ii) and (iii) are essentially 
examples of documents--prescriptions and sales receipts--that can 
contain separate statements confirming receipt of the prescription, and 
these methods of obtaining confirmation continue to be permitted under 
the final rule's broader option Sec.  456.4(a)(1)(i).
    The Commission adopts Sec.  456.4(a), which requires that the 
statement confirming receipt be separate. Prescribers should provide a 
signature line that clearly and conspicuously applies to a statement of 
confirmation that the patient has received their

[[Page 60763]]

prescription. If instead it is part of a multi-paragraph form 
containing unrelated information, such as advice about contact lens 
wear and care habits or the symptoms of eye infections, which then 
requests a signature at the end of the form, it may not be a valid 
method to request confirmation of prescription release. While 
additional information supplied on the model form may be useful to 
patients, it can confuse patients as to what it is they are signing 
for, and add additional time to the confirmation obligation. Indeed, as 
discussed in this document's PRA analysis section, the use of a model 
template from AOA containing several additional paragraphs unrelated to 
the confirmation requirement may well contribute to some prescribers' 
claims that it takes more than 10 seconds to obtain a contact lens 
prescription confirmation from a patient.\347\
    Section 456.4(a)(1)(ii) applies to instances where the prescriber 
provides a digital copy of the prescription to the patient and is, with 
one minor alteration,\348\ the same as the NPRM's proposed Sec.  
456.3(a)(1)(iv). If a prescriber provides the prescription digitally, 
after obtaining verifiable affirmative consent, the prescriber need not 
request the patient sign a separate statement confirming receipt. 
However, the prescriber does need to retain evidence that the 
prescription was sent, received, or made accessible, downloadable, and 
printable. In the final rule's Sec.  456.4(a)(1)(ii), that evidence 
serves as the ``confirmation of prescription release.''
    The Commission recognizes that by altering its NPRM proposal in 
this manner, the options for obtaining confirmation of prescription 
release in the Eyeglass Rule will not precisely mirror the language of 
the options provided in the Contact Lens Rule, but these are 
differences in textual language, not the Rules' policy or effects. The 
obligations for prescribers with respect to when and how to offer a 
prescription, and how prescribers can obtain and store a confirmation 
of receipt, are essentially the same for contact lens and eyeglass 
prescriptions. For clarity purposes, the Commission may address the 
language differences in the CLR's next periodic rule review. For these 
reasons, the Commission adopts Sec.  456.4(a) as set out in this final 
rule.
    The full text of the Rule amendment is located at the end of this 
document.
3. Final Rule Modification To Add Explicit Recognition of a 
Prescriber's Ability To Obtain a Confirmation on Paper or in a Digital 
Format
    If the prescriber provides a paper copy of the prescription to the 
patient, the prescriber must request that the patient acknowledge 
receipt by signing a separate statement confirming receipt of the 
prescription. As discussed above with respect to obtaining signatures 
of affirmative consent to digital delivery, participants at the 
workshop discussed that some EHR companies haven't updated their 
systems in light of the new CLR requirements to allow prescribers to 
collect signatures electronically, which would reduce the record-
keeping burden, and suggested that the Rule should expressly permit 
prescribers to obtain patient signatures digitally or on paper.\349\ 
Specifically, at the workshop, Dr. Repka stated that the electronic 
medical records of the future will be able to accept electronic 
signatures that will be stored in ways other than on paper and says, 
``if there's an option to do that, it would be nice. If you still 
needed it to be on a printable PDF, then not as convenient.'' \350\
    When proposing changes to the Eyeglass Rule, the Commission noted 
the ``recordkeeping burden could be reduced to the extent that 
prescribers have adopted electronic medical records systems, especially 
those where patient signatures can be recorded electronically and 
inputted automatically into the electronic record.'' \351\ The 
Commission resolves therefore to change the Rule to explicitly state 
that obtaining patient signatures ``on paper or in a digital format'' 
is permissible and complies with the Rule. Accordingly, Sec.  456.4 of 
the final rule sets forth this language. The Commission believes this 
will resolve prescriber confusion regarding the need to print out 
digital forms and collect wet signatures that might then need to be 
scanned and stored electronically in an EHR system. As with electronic 
collection of patient consent to digital delivery, alleviating 
prescriber misunderstanding regarding signature collection should help 
reduce waste and facilitate faster, more efficient, Rule 
compliance.\352\

V. Final Rule Pertaining to Proof of Insurance Coverage as Payment

A. Proposed Requirement in the NPRM To Treat Proof of Insurance 
Coverage as Payment and the Basis for Such Proposal

    The Eyeglass Rule requires that prescribers provide consumers with 
a copy of their prescription immediately after the eye examination is 
completed, but also contains a long-standing exception to allow a 
prescriber to refuse to give the patient a copy of their prescription 
until the patient has paid for the eye examination, so long as the 
prescriber would have required immediate payment had the eye 
examination revealed that no ophthalmic goods were required.\353\ The 
CLR contains a similar provision, permitting the collection of fees for 
an eye examination, fitting, and evaluation before the release of a 
contact lens prescription, but also provides clarification that for 
purposes of this exception, a patient's presentation of proof of 
insurance coverage for those services shall be deemed to constitute a 
payment.\354\ The Eyeglass Rule does not contain this insurance 
clarification, and staff has received questions from the public about 
this issue. The Commission proposed that such a proviso, which was 
initially formulated by Congress in drafting the FCLCA,\355\ be added 
to the Eyeglass Rule, both because it is appropriate that a patient's 
proof of insurance coverage equates to payment, and to bring the two 
rules into conformity and eliminate unnecessary confusion.\356\ 
Accordingly, in the NPRM the Commission proposed to amend Sec.  
456.2(a) to add the sentence, ``For purposes of the preceding sentence, 
the presentation of proof of insurance coverage for that service shall 
be deemed to be a payment.'' \357\ The Commission invited public 
comment on the potential benefits and burdens of such an 
amendment.\358\

B. Comments on NPRM and Discussion at Workshop Regarding the Insurance 
Coverage as Payment Proposal

    The Commission received a few public comments addressing this 
proposed amendment. NAROC supported the Commission's clarification that 
proof of insurance coverage shall be deemed to constitute a payment 
under Sec.  456.2(a), and opined that this clarification will generally 
increase compliance with the Rule's prescription release 
requirement.\359\ 1-800 CONTACTS also supported ``amending the [Rule] 
to follow the CLR in requiring that prescribers accept proof of 
insurance coverage as payment for purposes of automatic prescription 
release.'' \360\
    The AAO expressed concern that the provision could create 
challenges for, and ultimately result in financial impacts to, 
ophthalmology practices, such as instances where a patient has already 
utilized their insurance benefit and would thus be ineligible at the 
time of the visit to be covered by

[[Page 60764]]

insurance.\361\ Requiring the prescriber to accept proof of insurance 
as payment in such a situation would be problematic for the prescriber, 
since the insurance would not be obligated to pay anything. The AAO 
noted that a ``remedy for this would be to instead allow for insurance 
to be used as payment if the insurance carrier confirms that the 
patient is eligible for the benefit at the time of their visit.'' \362\ 
An anonymous commenter stated there can be a problem with vision plans 
showing authorizations for services but not guaranteeing payment, which 
takes advantage of the prescriber.\363\

C. Additional Discussion and Commission Determination Regarding the 
Insurance Coverage as Payment Proposal

    The Commission has decided that the proposed clarification in the 
NPRM's Sec.  456.2(a) will aid prescribers' compliance with the Rule 
and help ensure that patients and prescribers understand when a 
prescription should be released. Accordingly, the Commission is 
adopting the provision as proposed in the NPRM as Sec.  456.2(a)(2). 
Regarding the AAO's concern that prescribers should be allowed to wait 
until an insurance carrier confirms a patient's eligibility for a 
benefit at the time of service, the Commission notes that this is, in 
fact, what the provision would permit. Section 456.2(a)(2) states that 
proof of insurance coverage--not merely possession of an optical or 
health insurance policy--will be deemed to constitute payment. For the 
anonymous commenter who was concerned about vision plans that show 
authorizations for services but do not guarantee payment, this 
prescriber could withhold the prescription pending payment if coverage 
cannot be conclusively established. But in such a case, the prescriber 
also could not offer to sell the patient eyeglasses until after 
releasing the prescription to the patient.\364\
    Participants at the workshop discussed that some patients may 
prefer not to have to make two separate payments--one for the 
examination fee, prior to receiving the prescription, and a separate 
one for the purchase of eyeglasses, if they choose to purchase from 
their prescriber's office.\365\ Commission staff noted that the 
Eyeglass Rule does not mandate when prescribers collect payment for 
examination fees or eyeglasses, but instead merely requires that the 
prescription be released immediately after the exam and before offering 
to sell the patient eyeglasses.\366\ Prescribers may decide to wait to 
collect the examination fee until a purchase is completed, if they 
believe their patients have a strong preference for a single 
transaction, so long as they already released the prescription prior to 
making that sale.\367\

VI. Final Rule Regarding ``Eye Examination'' Terminology

A. Proposed Revision in the NPRM To Change ``Eye Examination'' Term to 
``Refractive Eye Examination'' and the Basis for Such Proposal

    The Rule defines an ``eye examination'' as ``the process of 
determining the refractive condition of a person's eyes or the presence 
of any visual anomaly by the use of objective or subjective tests.'' 
\368\ As discussed above, the Rule currently allows eye care 
prescribers to refuse to provide the patient with their prescription 
when the patient has not paid for the ``eye examination''--which refers 
back to the definition describing the refraction--as long as the 
prescriber does not have different policies for those whose examination 
revealed that no ophthalmic goods were required.\369\ In response to 
the ANPR, the AOA and several individual prescribers requested that the 
Commission modify the Rule to change the term ``eye examination'' to 
``refraction.'' \370\ These commenters stated that an eye examination 
determines the health of the eye and includes many components that are 
not used to determine the refractive condition. According to some 
commenters, the Rule's definition for, and use of, the phrase ``eye 
examination'' more accurately describes refractive services rather than 
the full scope of an eye examination.\371\ Commenters stated that the 
Rule should reflect that a comprehensive eye examination and a 
refraction are separate services,\372\ and that while eye health exams 
are typically covered by Medicare, the testing required to produce the 
refractive prescription may not be a covered service under Medicare or 
other insurance plans, and therefore patients may be required to pay 
out of pocket for the service.\373\ The commenters suggested that 
changing the Rule to reflect the separate services and payments 
involved would reduce consumer confusion.
    In the NPRM, the Commission responded to the ANPR commenters by 
proposing to replace the term ``eye examination'' with ``refractive eye 
examination'' throughout the Rule, noting that the Eyeglass Rule's 
purpose is to ensure that prescribers provide patients with a copy of 
their prescription at the completion of an eye examination determining 
the patient's refraction, and that this prescription must be provided 
free of any additional charge, without obligation, and without a 
waiver.\374\ The Commission opined that clarifying that the eye 
examination referred to in the Rule is a refractive examination would 
likely increase consumer understanding of their rights and prescriber 
compliance with the Rule. The Commission invited further public comment 
on the potential benefits and burdens of such an amendment; and asked 
whether the current definition in the Rule is a clear and accurate way 
of describing a refractive eye examination, whether using the term 
``refractive eye examination'' in place of ``eye examination'' could 
help avoid confusion over when the prescriber must release the 
prescription, and whether prescribers should be allowed to withhold 
release of the prescription subject to any charges other than the one 
due for the refractive eye examination.\375\

B. Comments on NPRM and Discussion at Workshop Regarding the 
``Refractive Eye Examination'' Proposal

1. Comments About the Proposed Terminology Change
    The FTC received some comments in support of the proposed 
terminology change. 1-800 CONTACTS agreed with the Commission's 
proposal to replace the term ``eye examination'' with the term 
``refractive eye examination'' throughout the Rule.\376\ The National 
Taxpayers Union asserted that clarifying that an ``examination'' 
triggering the prescription release requirement is ``one involving a 
refractive diagnostic . . . should provide some reduction in overhead 
for providers, who might otherwise spend time and effort explaining to 
the consumer those conditions under which a prescription is not 
automatically furnished.'' \377\ NAROC stated that it was not aware of 
compliance concerns arising from the use of the term ``eye 
examination'' versus ``refractive eye examination,'' and had never 
heard the complaint that a prescriber did not understand the context of 
the prescription-release requirement, but acknowledged that the 
proposed change would eliminate the issues described in the NPRM.\378\ 
NAROC further recognized that prescribers also conduct examinations 
that are not related to prescribing corrective eyewear, and noted that 
the proposed change might improve the FTC's ability to enforce the 
Rule, in that the prescriber would not have the

[[Page 60765]]

excuse that they did not understand scope of the term.\379\
    While not expressly taking a position on the NPRM proposal to 
change the terminology, the American Academy of Ophthalmology did 
express concern--in relation to insurance payments--that many patients 
are confused as to the difference between health exams that are covered 
by insurance and refractive exams which often are not.\380\ The 
association said the Commission could be ``more proactive'' in 
explaining that eye health exams and exams that lead to eyeglass 
prescriptions are not the same services.\381\
    AOA, while in favor of the proposed change in 2015, noted that its 
position had ``evolved'' since then,\382\ and opined that the 
terminology change ``may not truly address any confusion that exists,'' 
noting that the results of a refractive examination do not necessarily 
provide all the information needed to determine and devise an optical 
prescription.\383\ The AOA asked that if the FTC chooses to update the 
language as proposed, it should clarify that the update does not impact 
any State or Federal definitions of a comprehensive eye 
examination.\384\
    At the workshop, Dr. Beatty echoed the AOA's concern that consumers 
benefit most from a comprehensive eye examination, and worried that 
labeling the exam that results in a prescription a ``refractive exam'' 
starts to ``confuse patients as to what the value is for having a full 
eye exam, and can start to make that feel the same as having some exam 
that you are getting online without the presence of the doctor.'' \385\ 
At the same time, Dr. Beatty confirmed that the definition in the 
Eyeglass Rule accurately describes a refraction.\386\
2. Comments About the Need To Allow Prescribers To Make a Medical 
Decision To Withhold the Prescription, Where Appropriate
    Commenters also noted that while a refraction may be provided to a 
patient for the purpose of determining their most current and 
appropriate eyeglass prescription, it may also be ``completed as a 
`diagnostic tool' to assist in the determination of visual status when 
there are comorbidities in the visual system.'' \387\ In this case, the 
intent of the refraction may not be to create and provide a 
prescription for eyeglasses or contact lenses, but rather to understand 
how the patient's refractive error may be a factor in decreased vision, 
and to help diagnose medical conditions in the eye, such as macular 
degeneration or a cataract.\388\ In the latter scenario, the eye care 
professional may even determine that it is not appropriate to provide a 
prescription for corrective eyewear, if the refractive error is not the 
cause of the decreased vision and comorbidities are present. Commenters 
felt that the eye care provider should, in their discretion, be free to 
make the medical decision of whether to dispense the diagnostic 
refraction, and not be required by the Rule to release a copy of the 
prescription solely because they had tested the patients' refractive 
error.\389\ Commenters also stated that regardless of whether the 
provider releases the prescription in that case, they should be able to 
charge the patient for the diagnostic examination that was 
completed.\390\
3. Comments About the Permissibility To Charge for the Refraction, as 
Opposed To Charging for the Prescription Release
    Although the Rule allows eye care prescribers to withhold a 
patient's prescription until the patient has paid for the ``eye 
examination''--so long as the prescriber would have required immediate 
payment even if the exam had revealed that no ophthalmic goods were 
required--the Rule also prohibits prescribers from ``charg[ing] the 
patient any fee in addition to the ophthalmologist's or optometrist's 
examination fee as a condition to releasing the prescription to the 
patient.'' \391\ This provision is intended to prevent a once-common 
practice whereby prescribers would charge their patients a separate fee 
for releasing the prescription, which could, in turn, dissuade patients 
from taking their prescription to shop elsewhere for eyeglasses. Some 
commenters discussed that consumers can be confused about whether a fee 
is being charged for the exam or for the prescription, and that the 
Rule language has resulted in some patients believing that they do not 
have to pay for the refractive exam.\392\ Commission staff noted, based 
on their experience enforcing the Eyeglass Rule, that some practices 
may tell patients that there is a charge for the prescription, without 
indicating that the charge is actually for the refractive exam, rather 
than for receiving the prescription, and that this can lead to consumer 
confusion about their rights under the Rule.\393\

C. Additional Discussion and Commission Determination Regarding the 
``Refractive Eye Examination'' Proposal

    After considering all of the comments in the record on the question 
of the appropriate terminology for the ``eye examination'' definition, 
the Commission has decided to amend this term to ``refractive eye 
examination'' throughout the Rule.\394\ Both the comments the 
Commission received in 2015 and the panel discussion at the 2023 
workshop confirmed that the definition in the Rule most accurately 
describes a refraction. A refractive eye examination can be a portion 
of a more comprehensive exam, but by changing the terminology, the Rule 
will provide a clear indication to the consumer and prescriber that if 
the refraction has been completed, the prescription should be provided, 
barring a medical decision by the prescriber.
    By making this change, the Commission is not suggesting that 
consumers would not benefit from a comprehensive eye examination, or 
that it would be preferable for consumers to seek out solely a 
refraction in order to obtain their prescription. But the Commission is 
aware that a refraction can be completed in a variety of contexts, and 
wishes to clarify that regardless of the purpose of the examination, 
the prescription should always be released whenever the optometrist or 
ophthalmologist determines the patient's refractive error.\395\ The 
Commission is mindful, however, that in some cases in which the 
refraction may be used as a diagnostic tool, the provider may make a 
medical decision that it would not be appropriate for a patient to 
obtain eyeglasses. The Commission does not intend the Rule to override 
the provider's medical judgment in such cases. If a prescriber 
determines it is not medically appropriate for the results of a 
refractive exam to result in a prescription for a particular patient, 
the prescriber may choose not to release the prescription. But, in such 
cases, the prescriber may not then offer to sell the patient 
eyeglasses.\396\ Moreover, the prescription should not be withheld 
merely due to it being inconvenient for the prescriber to provide it.
    The Commission concludes that changing the term to ``refractive eye 
examination'' may help consumers understand that they may be required 
to pay for the refraction if it is not covered by a vision plan or 
other health insurance. Furthermore, this terminology change will help 
prescribers understand that while they may withhold the prescription 
pending receipt of payment for the refraction, it is not appropriate to 
make prescription-release contingent upon the payment for any 
additional service.
    The Commission plans to undertake additional consumer education 
after the Rule is amended to help patients understand that they may be 
charged for the exam, but not for the prescription

[[Page 60766]]

itself. Revised business education materials can also advise 
prescribers on the types of fees that may be assessed as a condition of 
prescription release, as well as advise them to train staff to 
communicate the purpose of fees to patients.

VII. Miscellaneous Issues Raised in Comments

A. Pupillary Distance

1. Background and Comments
    In the NPRM, the Commission explored whether to amend the Rule to 
require the inclusion of pupillary distance on eyeglass prescriptions. 
Pupillary distance is the measurement (in millimeters) of the distance 
between the pupils of a person's eyes and is typically needed to 
properly fit a pair of eyeglasses.\397\ The Rule has historically left 
it to the States to determine what measurements constitute a complete 
refractive prescription, and thus, it has been up to the States to 
determine whether pupillary distance is required to be included on 
prescriptions.\398\ In the NPRM, the Commission analyzed comments 
received in response to the ANPR in favor of and against adding a 
pupillary distance requirement and concluded that there was not 
adequate evidence in the rulemaking record at this time to determine 
that the failure to provide a pupillary distance on a prescription is 
an unfair practice.\399\ As a result, in the NPRM the Commission did 
not propose to require prescribers to include the pupillary distance 
measurement on prescriptions.\400\ However, since it had last invited 
comment on the question of whether to require the inclusion of 
pupillary distance in a prescription in 2015, and the market for 
optometry and eyeglasses may have evolved since then, the Commission, 
in the NPRM, again invited comment on this issue. Specifically, the 
Commission asked for input and information about changes to State 
regulation on the content of prescriptions, or to changes in the 
marketplace, or to changes in technology, that might affect and alter 
the Commission's prior conclusion that pupillary distance on 
prescriptions should not be required by rule.\401\
    In response, the Commission did not receive any comments addressing 
changes to State regulations on the content of prescriptions, or 
changes in the marketplace, or changes to technology pertaining to 
pupillary distance. Commenters in favor of and against the inclusion of 
pupillary distance on prescriptions largely reiterated viewpoints 
previously expressed in response to the ANPR.
    The Commission received a number of comments in favor of the 
Commission's NPRM determination not to require the inclusion of 
pupillary distance on prescriptions from optometry, ophthalmology, and 
optician trade groups (the AOA, AAO, and OAA, respectively). The AOA, 
for instance, agreed with the Commission's concern, as discussed in the 
NPRM, that requiring pupillary distance measurements on prescriptions 
could place the patient in the optical dispensary--where pupillary 
distance measuring devices are typically located and operated--prior to 
the patient receiving their prescription, thereby undercutting the 
Rule's long-standing principle (a foundation of the Rule) of separating 
a patient's eye examination from the retail dispensing of eyeglasses. 
The AOA and the OAA added further that, historically, taking pupillary 
distance measurements is not a standard part of an eye examination by 
an optometrist or ophthalmologist (it is typically performed by an 
optical goods dispenser, such as an optician, in the dispensary after a 
patient decides to purchase glasses), and stated that there was no 
reason to require that prescriptions from refractive eye exams, written 
by optometrists and ophthalmologists, should include pupillary 
distance.\402\ The AOA also pointed to Commission language in the NPRM 
stating that there are zero-cost and relatively-low-cost alternative 
methods for consumers to obtain their pupillary distance if they wish 
to shop for glasses online.\403\ The trade association NAROC also 
agreed with the Commission's NPRM determination, stating that if the 
pupillary distance requirement was added, prescribers and opticians 
might end up at odds over whose pupillary distance measurement should 
control.\404\
    The OAA further expressed concern that if pupillary distance is 
required on prescriptions, opticians filling the prescription would 
have to abide by the exact measurements written on the prescription by 
the prescriber, regardless of the accuracy of the information or their 
own measurement, and stated that opticians--who have a long history of 
performing pupillary distance measuring tests--may consider several 
factors such as: whether the current pupillary distance measurement 
matches the previous measurement, changes that may have occurred since 
the issuance of the prescription, and the complexity of the 
prescription.\405\
    The AAO also agreed with the Commission's decision not to mandate 
the inclusion of pupillary distance measurements on eyeglass 
prescriptions.\406\ The group said that because many ophthalmologists 
do not take this measurement, and not all ophthalmic practices have an 
optician on staff to perform these measurements, if pupillary distance 
were required on prescriptions, ophthalmologists would be forced to 
make difficult practice decisions over the hiring of additional staff 
or the elimination of refractive services.\407\
    On the other hand, some sellers and consumers said they would like 
the Commission to reconsider its decision and require prescribers to 
include pupillary distance on prescriptions. Online seller 
Eyeglasses.com stated that it receives hundreds of prescriptions from 
consumers each day and about half of them do not include the pupillary 
distance measurement, making it challenging to provide them with 
eyeglasses.\408\ The seller contended that the failure to provide 
pupillary distance is an obstacle to consumer choice, and expressed its 
belief that prescribers do not add this measurement because they either 
do not want to take the extra time to take the measurement, or because 
such prescribers sell eyeglasses themselves, and withhold the 
measurement to make it more difficult for consumers to buy eyeglasses 
elsewhere. According to Eyeglass.com, consumers are frequently too 
embarrassed to ask for the pupillary distance measurement, and if they 
do ask the prescriber, it gives the prescriber an opportunity to 
discourage the patient from buying online or elsewhere. The seller also 
noted that some prescribers charge a fee to measure the pupillary 
distance, which is not prohibited by the Rule.\409\
    1-800 CONTACTS, which also sells eyeglasses, reiterated the view 
that not giving consumers their pupillary distance measurement could 
discourage online shopping and result in diminished competition and 
less consumer choice.\410\ It opined that the elements of unfairness 
are met when a prescriber's office takes the pupillary distance 
measurement during the patient's visit but fails to automatically 
provide that measurement to the patient, and reiterated that patients 
may not know to ask for their pupillary distance, may not want to 
offend the prescriber by asking for that measurement, or may be refused 
or charged for that measurement.\411\ According to 1-800 CONTACTS, 
obtaining the pupillary distance measurement on their own may be a 
costly or time-consuming hassle for some consumers, and some consumers 
may not be aware of the ways in which they can obtain their pupillary 
distance

[[Page 60767]]

measurement. Moreover, in response to the Commission's stated concern 
that a pupillary distance requirement could have the unintended and 
undesirable consequence of placing the patient in the dispensary prior 
to them having their prescription in hand, 1-800 CONTACTS proposed that 
the pupillary distance measurement should be released in some other 
format, separate from the refractive prescription itself.\412\ For this 
scenario, the commenter explained, the prescriber would release the 
prescription prior to the patient entering the dispensary, and the 
patient would then automatically receive their pupillary distance 
measurement separately after having it measured in the dispensary.\413\ 
1-800 CONTACTS asserted that an appropriately tailored amendment to 
automatically release a pupillary distance measurement is critical to 
creating prescription portability and promoting competition in the 
evolving market for prescription eyewear.\414\
    Another commenter, a consumer, stated that pupillary distance 
measurements are needed to order glasses online, where glasses are much 
cheaper than in the optometrist's shop.\415\ The commenter said that, 
when they ask their prescriber for the measurement, the prescriber does 
not provide it, and instead tells them that the measurement will be 
taken when they buy eyeglasses. The commenter felt this was a way to 
force consumers to buy their eyeglasses at their prescriber's office, 
or at the least, discourage them from buying glasses online.\416\
2. Pupillary Distance Requirement Determination
    After considering the comments and evidence regarding pupillary 
distance, the Commission does not disturb its conclusion, reached in 
the NPRM and previous Eyeglass Rule rulemakings, not to mandate the 
inclusion of pupillary distance on prescriptions in States that do not 
otherwise include such a requirement. To determine an act or practice 
is unfair, the Commission must find that the act or practice causes or 
is likely to cause substantial injury to consumers; the injury is not 
reasonably avoidable by consumers themselves; and, the injury is not 
outweighed by countervailing benefits to consumers or to 
competition.\417\ The comments submitted in response to the NPRM did 
not reveal any relevant changes in the marketplace, technology, or 
State regulations that sufficiently alter the landscape such that not 
providing a pupillary distance measurement is generally unfair. The 
comments largely raise the same points as those submitted in response 
to the ANPR,\418\ indicating that requiring the inclusion of pupillary 
distance measurements on prescriptions could potentially increase 
consumer convenience and improve competition, but could also impose 
burdens on prescribers, hamstring opticians, and undercut other pro-
competitive aspects of the Rule. On balance, upon review of the record, 
the Commission finds again that there is not sufficient evidence that 
the practice of not providing pupillary distance is an unfair act or 
practice.
    Purchasing eyeglasses online can, indeed, be more convenient and 
less costly for consumers, and consumers can find it more difficult to 
shop online if their pupillary distance is not provided by prescribers. 
But every State determines what is required to be included in an 
eyeglass prescription, and only four require the inclusion of pupillary 
distance measurements.
    Based on the record developed, the Commission concludes that 
preempting these State determinations by imposing a requirement to 
include pupillary distance on the prescription may have a detrimental 
overall effect for prescribers and consumers. Some prescribers--
particularly ophthalmologists--would be required to take a measurement 
they do not ordinarily take, or might feel obligated, for professional 
and liability reasons, to hire new staff or acquire new equipment to 
take this measurement, which could result in higher costs passed on to 
patients in the form of higher prices.\419\ Particularly for smaller 
practices, the costs to these providers could be considerable.
    In addition, imposing such a requirement could undermine the pro-
competitive aim of the Rule. If the Commission required the inclusion 
of pupillary distance, some prescribers might lead patients to the 
dispensary for the measurement, instead of adding expensive pupillary 
distance measurement equipment to the exam room.\420\ As noted above, 
such a shift would place the patient in the dispensary prior to the 
patient receiving their prescription, a result that would blur the 
important distinction between the clinical eye exam and the retail 
dispensing process, a distinction that is central to the Rule, and that 
the Commission has consistently attempted to preserve.
    Although commenters point to circumstances under which the act of 
not providing a pupillary distance measurement can be injurious, 
consumers have alternative means to obtain eyeglasses from a seller 
other than their prescriber. Other methods are available for consumers 
to obtain this measurement, and many of these methods--while possibly 
not as precise as a measurement taken with expensive equipment by an 
optician in a dispensary--are low-cost or no-cost. For instance, one 
seller stated that all you need is a mirror and a printable ruler,\421\ 
and another provided instructions for using their digital ruler.\422\ 
Consumers can also obtain this measurement at an in-person optical 
dispensary, though it may come at a small cost if the consumer is not 
purchasing eyeglasses at that shop.\423\ Although some consumers 
reported problems with their vision when using eyeglasses made with 
pupillary distances they measured themselves using online tools,\424\ 
NAROC stated that many online sellers have developed accurate 
alternative ways to measure pupillary distance.\425\ Moreover, a new 
pupillary distance measurement does not have to be obtained every year 
or office visit. Obtaining it once is usually sufficient, since for 
most people, the measurement does not change significantly from one 
year to the next. The widespread availability of these alternative 
methods make it difficult to conclude at this time that the injury to 
consumers from prescribers failing to take and provide pupillary 
distance measurements is both substantial and not reasonably avoidable.
    Importantly, the Commission's determination does not preclude 
States from defining prescriptions to include pupillary distance 
measurements. Indeed, in the handful of States that already do so, the 
Rule, by its operation, requires dispensing of such measurements. But 
the Commission is mindful that the vast majority of States have not 
required prescribers to include pupillary distance measurements, and 
the Commission is reluctant to override the determinations of local 
jurisdictions without a clearer record establishing that the status quo 
is unfair.
    For these reasons and others described in the Commission's 
NPRM,\426\ the Commission has decided at this time to retain its prior 
conclusion not to amend the Rule to add a pupillary distance 
requirement for prescriptions.\427\

B. Consumer and Business Education

    Commenters and workshop participants stated that the Commission 
should better educate consumers about their rights to their 
prescription, or the confirmation process. Dr. Masoudi stated that 
consumers should be made more aware of their rights before they walk in 
the door.\428\ This point was illustrated at the workshop by Felecia 
Neilly, who stated that before she became involved with this Rule 
review

[[Page 60768]]

process, she ``wasn't even aware of an eyeglass rule'' and did not know 
she had the option to receive the prescription.\429\ As to the 
confirmation requirement, Dr. Montaquila stated that there is 
widespread confusion by his patients as to why they are signing a 
prescription.\430\ One anonymous commenter stated that the burden 
should be on the FTC to provide education to the consumer.\431\ The AAO 
added its concern that patients misunderstand that services resulting 
in a prescription, in addition to the prescription, are to be provided 
free of charge.\432\
    Some commenters also mentioned that in addition to a need to 
educate consumers, there is a need to educate prescribers about their 
responsibilities under the Rule. NAROC requested the Commission work 
with industry to develop useful guidance or templates relating to 
patients' rights and prescribers' responsibilities with respect to 
eyewear prescription release.\433\
    The Commission has existing guidance on the Eyeglass Rule on its 
website and has engaged in outreach to both consumers and prescribers 
at periodic intervals, including through press releases, consumer 
alerts, and business blogs announcing warning letters to 
prescribers.\434\ Nevertheless, it agrees it should bolster its 
existing guidance on the Rule as an added measure to inform consumers 
of their rights, and businesses of their obligations, especially given 
the amendments to the Rule.

VIII. Paperwork Reduction Act

    The Paperwork Reduction Act (``PRA''), 44 U.S.C. 3501 et seq., 
requires Federal agencies to obtain Office of Management and Budget 
(``OMB'') approval before undertaking a collection of information 
directed to ten or more persons. Pursuant to the regulations 
implementing the Paperwork Reduction Act,\435\ an agency may not 
collect or sponsor the collection of information, nor may it impose an 
information collection requirement unless it displays a currently valid 
OMB control number.
    In this final rule, the Commission is amending a rule that contains 
recordkeeping and other collection of information requirements as 
defined by OMB regulations that implement the PRA. First, the 
Commission is modifying the Rule to require that: (i) if a paper copy 
of the prescription was provided to the patient, the prescriber must 
request that the patient acknowledge receipt of the prescription by 
signing a separate statement on paper or in a digital format confirming 
receipt of the prescription, and retain the confirmation for not less 
than three years; or (ii) if a digital copy of the prescription was 
provided to the patient (via methods including an online portal, 
electronic mail, or text message), the prescriber must retain evidence 
that such prescription was sent, received, or made accessible, 
downloadable, and printable.\436\
    Section 456.4(a)(2) provides sample language for option paragraph 
(a)(2)(i) in that prescribers may use the single-sentence statement, 
``My eye care professional provided me with a copy of my prescription 
at the completion of my examination,'' but also allows prescribers to 
craft their own wording of the signed confirmation if they so desire. 
For prescribers who choose to offer an electronic method of 
prescription delivery, the Rule will require that such prescribers 
identify the specific method or methods to be used and maintain records 
or evidence of affirmative consent by patients to such digital delivery 
for at least three years. For instances where a consumer refuses to 
sign the confirmation or accept digital delivery of their prescription, 
the Rule (Sec.  456.4(a)(3)) directs the prescriber to note the refusal 
and preserve this record as evidence of compliance. None of these new 
requirements, however, would apply to prescribers who do not have a 
direct or indirect financial interest in the sale of eyeglasses.
    Below, the Commission describes and discusses the changes between 
the proposed rule regulatory text and this final rule, the public 
comments received relating to the collection of information burden, and 
the Commission's ultimate determination of the burden generated by the 
final rule.

A. Comments Regarding the NPRM Estimate for the Confirmation-of-
Prescription-Release Requirement

    In its NPRM, the Commission put forth estimates for the burden on 
individual prescribers' offices to generate and present to patients the 
confirmations of prescription release, and to collect and maintain the 
confirmations of prescription release for a period of not less than 
three years. Based on an estimate that there are 165 million eyeglass 
wearers in the United States, the Commission calculated the total 
disclosure and recordkeeping burden from the new requirement at 
2,979,167 hours for prescribers and their staff (1,375,000 disclosure 
hours + 1,604,167 recordkeeping hours).\437\ These totals were based on 
estimates that it would take prescribers' offices one minute to hand 
out a prescription, ten seconds for the patients to read and sign a 
confirmation-of-prescription-release statement or consent-to-
electronic-prescription-delivery, and one minute for prescribers' 
offices to store (or scan and save) the signed confirmation or consent 
in their files.\438\ The Commission's time estimates were based on 
previously-approved estimates for a nearly identical confirmation-of-
prescription-release requirement added to the Contact Lens Rule in 
2020.\439\
    In its NPRM, the Commission requested comment on, among other 
things, the accuracy of the FTC's burden estimates, including whether 
the methodology and assumptions used were valid.\440\ In response, the 
Commission received various comments from prescribers opining, among 
other things, that a confirmation requirement for eyeglass 
prescriptions would ``take an immense amount of time and take away from 
patient care,'' \441\ be ``very time consuming,'' \442\ and ``add a 
significant burden to small business optometry practices that already 
are enduring financial challenges and staffing issues.'' \443\ More 
specifically, some commenters, such as the American Optometric 
Association and Eyeglass workshop panelist Dr. Jeffrey Michaels stated 
that the Commission had previously underestimated the time it takes to 
perform the confirmation requirement,\444\ and commenter Coast Eyes 
Pllc suggested the paperwork cost would be $18,000 per provider per 
year.\445\ Another workshop panelist, Dr. Stephen Montaquila concurred 
with Dr. Michaels, commenting that it takes his staff four minutes to 
complete the entire Contact Lens Rule process of printing out a 
patient's prescription, handing it to the patient, explaining why it 
needs to be signed, having the patient sign it, making a copy of it, 
and storing the signed copy as a record.\446\ In addition, the National 
Taxpayers Union submitted a comment stating that while it generally 
supports the confirmation requirement, ``[G]iven the various reading 
speeds of customers who may be elderly or have limited proficiency in 
English, the 10-second estimate [to read and sign the statement] could 
prove low.'' \447\ As noted previously in the discussion of the 
proposed confirmation requirement, the NTU also suggested that smaller 
optometry practices might bear a disproportionate share of the burden, 
which it estimated--based on the NPRM proposal and the estimate that 
that a ``modest optometry establishment'' might perform 3000 
examinations per year--at an additional 167 hours and $4,123 per year 
for such an establishment.\448\

[[Page 60769]]

    Some commenters, however, disagreed that it would take a 
significant amount of time to obtain a patient's signed confirmation. 
The NAROC commented that thousands of optometrists affiliated in co-
location with NAROC member companies ``regularly comply with [Contact 
Lens Rule confirmation-of-prescription-release requirements, as well as 
other requirements of the CLR and Eyeglass Rule] with little or no 
added cost or other burden on the eye care practice.'' \449\ According 
to NAROC representative and Eyeglass Rule workshop panelist Joseph 
Neville, ``I've personally witnessed a couple of situations where the 
process for contact lenses seemed very easy. . . . the prescription was 
handed over at the front desk by the staff person, and the staff person 
maybe a bit simplistically said, `We'd like to ask you to sign this 
receipt for your prescription. We're required to get your signature 
acknowledging that you've received it.' And a couple of people, and 
again, anecdotes here that I witnessed on this, just said, `Okay, fine, 
thank you.' '' \450\
    All of the above comments, however, are, as Mr. Neville 
acknowledged, anecdotal in nature.\451\ The only new empirical evidence 
that the Commission is aware of regarding the time it will take 
prescribers and their staff to comply with a confirmation-of-
prescription-release requirement comes from an American Optometric 
Association submission filed in response to a 2023 request for comment 
about extending Office of Management and Budget (``OMB'') clearance for 
the information collection requirements of the Contact Lens Rule.\452\ 
In that submission, the AOA said that the Commission ``significantly 
underestimated'' how long it would take prescribers to confirm 
prescription release for the Contact Lens Rule requirement, and cited a 
2023 survey it conducted of some of its member optometrists which found 
that 84.8% report it takes 30 seconds or more to obtain the patient's 
signed confirmation for contact lens prescriptions, not counting 
additional time necessary to address patient questions about the form 
they are signing, and 69.9% of prescribers said patients ``typically'' 
have questions regarding the acknowledgment.\453\ Since the 
confirmation-of-prescription-release requirement adopted herein is very 
similar to that for the Contact Lens Rule, the Commission regards AOA's 
comment regarding the CLR's burden as on point.
    The Commission cannot, however, accord the AOA survey significant 
weight. As explained in the Commission's notice responding to public 
comments on extending OMB's approval for CLR collection of information 
for another three years,\454\ it is very likely the AOA survey 
overestimates the average time necessary to obtain a confirmation 
because of the manner in which the survey solicited prescribers to 
respond. AOA emailed a newsletter to members and included an invitation 
to ``Voice your concerns'' about complying with the Contact Lens Rule. 
A small number of prescribers self-selected in response, and took part 
in the survey. Because the poll only included prescribers who responded 
to this invitation, it is questionable whether its findings are truly 
representative of the average prescriber.\455\ Furthermore, framing the 
survey as an invitation for concerned prescribers to air their 
grievances rather than as a disinterested information-gathering tool 
affects the objective reliability of survey responses, making it much 
harder for the Commission to accord it significant weight.
    The Commission also reiterates concerns--previously detailed in the 
Commission's CLR PRA Notice \456\--that the amount of time prescribers 
ascribe to patients reading and signing that Rule's confirmation 
statement may, in fact, be due largely to non-mandated choices with 
respect to the design of the statement. The Contact Lens Rule requires 
that patients read and sign a simple statement confirming receipt of 
their prescription, and allows that the one-sentence statement, ``My 
eye care professional provided me with a copy of my contact lens 
prescription at the completion of my contact lens fitting,'' fully 
satisfies the requirement. However, the Contact Lens Rule also permits 
prescribers to design their own confirmation form and statement, and 
the survey did not specify or ask prescribers what form or wording of 
the confirmation statement that patients were reading and signing, 
making it difficult to determine a true average time it would take to 
comply with the requirements of the rule. Even more concerning (from 
the standpoint of assessing the burden) is that the AOA has supplied 
its members with a model template confirmation form that includes 
several additional paragraphs consisting of ``important information to 
review prior to receiving your contact lens prescription.'' \457\ This 
information includes various recommendations from the Centers for 
Disease Control (``CDC'') and the Food and Drug Administration 
(``FDA'') about healthy contact lens use (such as ``Take out your 
contacts and call your eye doctor if you have eye pain, discomfort, 
redness, or blurry vision'') as well as five bullet points listing some 
of the symptoms for an eye infection (``Irritated, red eyes, worsening 
pain in or around the eyes,'' etc.).\458\ While the template document 
is titled ``Contact Lens Prescription Acknowledgment Form,'' only at 
the very end is there a statement, ``Sign below to acknowledge that you 
were provided a copy of your contact lens prescription at the 
completion of your contact lens fitting.'' \459\
    According to workshop panelist Dr. Montaquila, the AOA template is 
a common form that eye doctors are using to obtain patient 
confirmations.\460\ If this is indeed the case, it calls into question 
the relevance of AOA's survey results finding that it takes patients 30 
seconds or longer to comply with the Contact Lens Rule requirements, 
since the majority of those 30 seconds would likely be taken up by 
patients reading information that the rule does not require, or even 
suggest, that they read. Widespread use of AOA's model template 
confirmation form might also account for why prescribers report that 
patients have questions, or are confused, as to why they need to sign a 
new form, since patients are being asked not merely to confirm they 
received their prescription, but that they received other information 
from the CDC and FDA.\461\ While the additional information from these 
two Federal agencies may very well be useful to provide to patients, it 
is not required by the FTC, and the time it takes patients to read it 
is not part of the Rule's burden of compliance.
    Despite the aforementioned concerns about the reliability of the 
AOA's survey in establishing the time it takes for a patient 
confirmation, the Commission does not wholly discount the survey, but 
rather views it as suggestive, and an additional indication that many 
prescribers sincerely believe the Commission's 10-second estimate does 
not accurately reflect the time required to obtain a patient's signed 
confirmation. The Commission has therefore decided to increase its 
estimate for the time required to obtain a patient confirmation 
signature (and the time to collect an affirmative consent to electronic 
delivery, in instances where the prescription is provided digitally 
rather than in paper) for the Eyeglass Rule from 10 seconds--as 
proposed in the NPRM--to 20 seconds for this final rule. The Commission 
concludes that 20 seconds may better reflect the time required for a 
patient to not just read a one-sentence confirmation, but also to 
physically sign

[[Page 60770]]

and return the document to prescriber's staff, and for any necessary 
staff explanation as to why the patient's signature is required.\462\ 
The 20-second estimate may also better align with the original HIPAA 
estimate that was a basis for the initial CLR confirmation estimate, 
since the original HIPAA proposal accorded 10 seconds to hand out the 
acknowledgment and another 10 seconds to obtain a patient's signature 
and collect the document.\463\
    The Commission hereby provides PRA burden estimates, analysis, and 
discussion for the existing Eyeglass Rule burden of automatically 
releasing a prescription at the completion of a refractive eye exam, as 
well as the new requirement to collect patient signatures as 
confirmation of prescription release or as consent to electronic 
prescription delivery. The Commission estimates these PRA burdens based 
on the comments and submissions discussed above, in conjunction with 
its long-standing knowledge and experience with the eye care industry. 
The Commission is submitting these amendments and a Supporting 
Statement to OMB for review.

B. Commission Estimate of the Total Burden = 3,208,333 Hours

1. Estimated Hour Burden of 1,375,000 Hours for Prescribers To Release 
Prescriptions
    The number of adult eyeglass wearers in the United States is 
currently estimated to be approximately 165 million.\464\ Assuming a 
biennial refractive eyeglass exam for each eyeglass wearer,\465\ 
approximately 82.5 million people would receive a copy of their 
eyeglass prescription every year. Historically, the Commission has 
estimated that it takes one minute to provide the patient with a 
prescription copy.\466\ It is possible that one minute is an 
overestimate of the amount of time required, particularly as more 
doctors move to digital delivery. As of now, however, we have not seen 
sufficient evidence to merit making a change to the approach we have 
taken in the past. We therefore estimate an annual disclosure burden 
for prescribers to formulate and release prescriptions of approximately 
1,375,000 hours (82.5 million annual exams x 1 min/60 mins).
2. Estimated Hour Burden of Prescribers' Staff To Obtain and Store 
Patient Confirmation of Prescription Release = 1,375,000 Hours (343,750 
Hours for Patients To Read and Sign Confirmations, 1,031,250 Hours for 
Prescribers' Offices To Scan and Store Such Confirmations)
    The requirement to generate and present the confirmation of 
prescription release will not require significant time or effort. The 
requirement is flexible in that it allows different modalities and 
delivery methods at the discretion of the prescriber. The requirement 
is also flexible in that it does not dictate other details, such as the 
precise content or language of the patient confirmation. At the same 
time, prescribers and their staff would not be obligated to spend time 
formulating their own content for the confirmation, since the amended 
Rule provides draft language that prescribers are free to use, should 
they so desire. Furthermore, prescribers likely have forms and systems 
in place to maintain confirmation records already, since they already 
must comply with the similar confirmation requirement of the Contact 
Lens Rule, and may need make only minor adjustments to accommodate 
confirmations for eyeglasses prescriptions. As a result, the marginal 
cost of the Confirmation amendment to the Eyeglass Rule should be 
extremely low, possibly lower than that estimated herein.
    As noted above, the requirement of Sec.  456.4(a)(1)(i) to collect 
a patient's signature on the confirmation of prescription release and 
preserve it constitutes a new information collection as defined by OMB 
regulations that implement the PRA. Nonetheless, the Commission 
determines it will require minimal time for a patient to read the 
confirmation and provide a signature. As noted above, the Commission 
estimated in the Contact Lens Rule and the NPRM that it would take 
patients 10 seconds to read the one-sentence confirmation of 
prescription release and provide a signature.\467\ However, for the 
reasons discussed above, the Commission now believes that 20 seconds is 
an appropriate estimate for this task.\468\
    The second option, Sec.  456.4(a)(1)(ii), involves digital delivery 
of the prescription and does not, in and of itself, constitute an 
information collection under the PRA, since no new information that 
would not otherwise be provided under the Rule is provided to or 
requested from the patient.\469\
    In its NPRM, the Commission assumed that prescribers would elect 
digital prescription delivery 25% of the time, and thus would be 
required to obtain a signed confirmation for the other 75% of patients 
receiving prescriptions.\470\ That assumption was based on the premise 
that the NPRM offered prescribers four options (confirmation on a 
stand-alone document, confirmation on a prescription copy, confirmation 
on a sales receipt, or digital delivery with no confirmation required). 
With no specific details that clearly show which option prescribers 
would prefer, the Commission employed the assumption that prescribers 
would choose each of four options in equal numbers.
    The current Rule amendment has only two options, paper delivery or 
digital delivery, and thus if the Commission used the same equal-share 
assumption it followed in the NPRM, the percentage attributed to 
digital delivery (and thereby not implicating the burden of a 
confirmation) for PRA purposes would be 50%. However, based on 
conversations with prescribers and the industry, the Commission has 
reason to believe that regardless of widespread EHR adoption, many 
prescribers still do not provide patient portals or deliver 
prescriptions digitally to patients, and thus it would not be correct 
to designate 50% of all prescription releases as digital delivery. 
Further supporting this view, the aforementioned AOA survey found that 
only 35% of prescribers said they provided prescriptions 
electronically.\471\ Even that might overcount the number of 
prescriptions delivered digitally, since the prescribers surveyed by 
AOA about their method for either obtaining patient confirmations and 
delivering prescriptions were permitted to select more than one option, 
so some of the 35% who chose digital delivery of prescription (and thus 
no confirmation) may also have responded that they use other options, 
meaning that the overall percentage of prescriptions released 
electronically is actually less than 35%.\472\ Furthermore, as 
discussed above, there are questions as to the reliability of AOA's 
survey findings, and whether they are truly representative of the 
average prescriber. Therefore, in order to ensure that the PRA burden 
for the Rule is not underestimated, the Commission will retain the 
previously used assumption that just 25% of prescribers employ digital-
prescription delivery, and the other 75% of approximately 82.5 million 
annual prescription releases require a consumer reading and signing a 
confirmation statement. Thus, assuming twenty seconds for each such 
release, prescribers' offices would devote

[[Page 60771]]

343,750 hours, cumulatively (75% x 82.5 million prescriptions yearly x 
20 seconds each/60 secs/60 mins) to obtaining patient signatures as 
confirmations of prescription release.\473\
    Maintaining those signed confirmations for a period of not less 
than three years should not impose substantial new burdens on 
individual prescribers and office staff. Since the Rule allows 
flexibility in how prescribers craft the confirmation statement, 
prescribers may add it to documents that they would already be saving, 
such as prescription copies (and the majority of States already require 
that optometrists keep records of eye examinations for at least three 
years \474\) or customer sales receipts (which are normally preserved 
for financial accounting and recordkeeping purposes). Even if the 
prescriber chooses to create and use a separate confirmation statement, 
storing a one-page document per patient per year should not require 
more than a few seconds, and an inconsequential, or de minimis, amount 
of record space. Some prescribers might also present the confirmation 
of prescription release in electronic form, enabling patients to sign a 
computer screen or tablet directly, and have their confirmation 
immediately stored as an electronic document.
    For other prescribers, however, the recordkeeping requirement would 
likely require that office staff electronically scan the signed 
confirmation and save it as a digital document. For prescribers who 
preserve the confirmation by scanning it, Commission staff estimates 
that preserving such a document would consume approximately one minute 
of staff time.
    The Commission does not possess information on the percentage of 
prescribers' offices that currently use and maintain paper records 
versus electronic records, or that scan paper files and maintain them 
electronically. Thus, for purposes of this PRA analysis, and to again 
guard against possibly underestimating the Rule's burden, the 
Commission will assume that all prescriber offices who opt for Sec.  
456.4(a)(1)(i) (who do not dispense prescriptions electronically) 
require a full minute per confirmation statement for storing such 
recordkeeping.
    Assuming--as the Commission did above--that 25% of prescriptions 
will be delivered electronically, and thus 75% of prescriptions require 
a patient confirmation that must be scanned and saved, the 
recordkeeping burden for all prescribers' offices to scan and save such 
confirmations amounts to 1,031,250 hours (75% x 82.5 million 
prescriptions yearly x one minute for scanning and storing/60 mins) per 
year.
3. Estimated Hour Burden on Prescribers' Offices To Obtain and Store 
Patient Consents to Electronic Delivery = 458,333 Hours (114,583 Hours 
To Obtain Signed Consents and 343,750 Hours To Store Same)
    As noted previously, Sec.  456.4(a)(1)(ii), the second option for 
satisfying the confirmation-of-prescription-release requirement, 
involves digital delivery of prescriptions, and thus does not 
necessitate that prescribers obtain or maintain a record of the 
patient's signature confirming receipt of a prescription. However, this 
option does require that prescribers obtain and maintain records or 
evidence of the patients' affirmative consent to electronic delivery 
for three years. Based on the previous estimate that 25% of patients 
will receive digital delivery of their prescriptions, the Commission 
will use the assumption that consumers sign such consents for 
electronic delivery for one quarter of the 82.5 million prescriptions 
released per year,\475\ and that this task would take the same amount 
of time as to obtain and preserve a signature of the patient's 
confirmation of prescription release. Thus, the Commission will assign 
114,583 hours for the time required for prescribers' offices to obtain 
patients' affirmative consent to electronic delivery of their 
prescriptions \476\ and 343,750 hours for the time to store and 
maintain such records.\477\
    In total, the estimated incremental PRA recordkeeping burden for 
prescribers and their staff resulting from adding the confirmation-of-
prescription-release requirement to the Rule amounts to 1,833,333 total 
hours (343,750 and 114,583 hours, respectively, to obtain signatures 
confirming release and consenting to electronic delivery, plus 
1,031,250 and 343,750 hours, respectively, to maintain records of 
confirmation and consent for three years) for prescribers' offices. 
Adding this incremental PRA burden to the 1,375,000-hours burden 
resulting from the existing prescription-release requirement yields a 
total PRA disclosure and recordkeeping burden from the Rule of 
3,208,333 hours for prescribers and their staff.

C. Estimated Labor Cost

    The Commission derives labor costs by applying appropriate hourly-
cost figures to the burden hours described above. Since prescribers 
conduct patient examinations and formulate the prescriptions, the time 
spent releasing prescriptions to patients has traditionally been 
attributed for PRA purposes to prescribers, rather than their office 
staff. As for the task of obtaining patient confirmations and consent 
to electronic delivery, this could be performed by prescribers or their 
support staff. In the past, the task of collecting patient signatures 
was attributed to prescribers, but based on more recent conversations 
with prescribers and others in the industry, it has become evident that 
this task is more appropriately designated as performed by prescribers' 
office staff.\478\ Therefore, the Commission will continue to assume 
that prescribers release prescriptions to patients, but that 
prescribers' office staff perform the task of collecting patient 
signatures on confirmations and digital-release consents, as well as 
the labor pertaining to printing, scanning, and storing of both 
documents.
    According to the U.S. Bureau of Labor Statistics (``BLS''), general 
office clerks earn an average wage of $20.94 per hour, optometrists 
earn an average wage of $68.75 per hour, and ophthalmologists--which 
are listed by BLS under ``surgeons''--earn an average wage of $150.06 
per hour.\479\ Using the average wage for office clerks, and the 
aforementioned estimate of 1,833,333 total hours for office staff to 
obtain signed patient confirmations and consents to digital 
prescription delivery and to store such documents, the Commission 
calculates an incremental burden of $38,389,993 from adding the 
confirmation of prescription release to the Eyeglass Rule.\480\
    Based on our knowledge of the industry, we assume that of the 
1,375,000 prescriber-labor hours relating to the Rule's requirement to 
release a copy of the prescription to the patient, optometrists are 
performing 85% (1,168,750) of such hours and ophthalmologists are 
performing the remaining 15% (206,250) of such hours. Applying this to 
the BLS wage figures results in a prescriber-labor burden for the 
existing burden of releasing prescriptions of $111,301,438 ($80,351,563 
for optometrists + $30,949,875 for ophthalmologists).
    Adding the $38,389,993 staff burden from the confirmation-of-
prescription-release requirement to the $111,301,438 prescriber burden 
from the automatic prescription-release requirement already in place 
yields a total estimated annual labor cost burden for the Eyeglass Rule 
of $149,691,431. While not insubstantial, this amount constitutes less 
than one half of one percent of the estimated $35.6 billion retail 
market for eyeglass sales in the United States in 2022.\481\ 
Furthermore, the actual burden

[[Page 60772]]

is likely to be less, because, as noted supra, prescribers who do not 
have a financial interest in the sale of eyewear will not be required 
to obtain patient confirmations, many prescribers' offices will require 
less than a minute to store the confirmation form, prescribers can use 
the same document to obtain confirmations for eyeglass prescriptions 
and contact lens prescriptions, and, as digital prescription delivery 
increases over time, the overall burden should correspondingly 
decrease.

D. Capital and Other Non-Labor Costs

    The recordkeeping requirements detailed above regarding prescribers 
impose negligible capital or other non-labor costs, as prescribers 
likely have already the necessary equipment and supplies (e.g., 
prescription pads, patients' medical charts, scanning devices, 
recordkeeping storage) to perform those requirements.

IX. Final Regulatory Analysis and Regulatory Flexibility Act Analysis

    Under section 22 of the FTC Act, 15 U.S.C. 57b-3, the Commission 
must issue a final regulatory analysis related to a final rule only 
when it: (1) estimates that the amendment will have an annual effect on 
the national economy of $100,000,000 or more; (2) estimates that the 
amendments will cause a substantial change in the cost or price of 
certain categories of goods or services; or (3) otherwise determines 
that the amendments will have a significant effect upon covered 
entities and upon consumers. The Commission has determined that this 
final rule will not have such an annual effect on the national economy, 
on the cost or prices of goods or services, or on covered businesses or 
consumers.
    The amendments adopted in this final rule require that prescribers 
obtain from patients, and maintain for a period of no less than three 
years, a signed confirmation of prescription release acknowledging that 
patients received their eyeglass prescriptions at the completion of 
their eye examination. The amendments also require some prescribers to 
obtain and maintain for three years a patient's consent to deliver 
prescriptions electronically, but only for prescribers who elect to 
offer this method of delivery as an alternative to providing 
prescriptions in paper, and only if the patient agrees.
    As discussed in the Paperwork Reduction Act section of this 
document, the Commission approximates that collecting a patient's 
signature on the confirmation of prescription release (giving time for 
the patient to read the confirmation) in accordance with Sec.  456.4 
will take approximately 20 seconds. Providing the patient with the 
confirmation of prescription release in accordance with this provision 
will require prescribers' offices to present a statement of 
prescription release and request a patient signature. The amendment 
provides prescribers with language that they can use on a confirmation 
form, which will relieve prescribers of the burden of coming up with 
such language. This requirement may also involve some staff training, 
which should be minimal, particularly since prescribers' staff will 
already be trained in obtaining patient confirmation of prescription 
releases under the Contact Lens Rule.\482\ As a result, complying with 
Sec.  456.4(a) will impose only minimal incremental costs on 
prescribers' offices.\483\
    The PRA section of this document also addresses the burden under 
Sec.  456.4(b) for prescribers to maintain, for at least three years, 
records confirming their patients' receipt of prescriptions, and 
estimates it will take one minute for prescribers' staff to meet their 
recordkeeping obligations. This likely overstates the recordkeeping 
burden, since, as noted above, storing a one-page document per patient 
per year should not require more than a few seconds, and an 
inconsequential, or de minimis, amount of record space. Prescribers who 
decide to collect or maintain signatures electronically may already 
have electronic health records in place. Some prescribers might also 
present the confirmation of prescription release in electronic form, 
enabling patients to sign a computer screen or tablet directly, and 
have their confirmation immediately stored as an electronic document.
    As further noted in the Paperwork Reduction Act section of this 
final rule, the estimated cost to prescribers of complying with all of 
the requirements of the Eyeglass Rule is just .0042 of the total retail 
market for prescription eyeglass sales, with the cost of this final 
rule representing less than a third of that amount. In sum, the burdens 
imposed on small entities are likely to be relatively small.
    The Regulatory Flexibility Act (``RFA''), 5 U.S.C. 601-612, 
requires an agency to provide an Initial Regulatory Flexibility 
Analysis (``IRFA'') with a proposed rule and a Final Regulatory 
Flexibility Act (``FRFA'') with the final rule, if any, unless the 
agency certifies that the rule will not have a significant impact on a 
substantial number of small entities.
    In the NPRM, the Commission determined the proposed amendments 
should not have a significant or disproportionate impact on 
prescribers' costs, and based on available information, the Commission 
certified that amending the Rule as proposed in the NPRM, would not 
have a significant impact on a substantial number of small entities. 
Nonetheless, the Commission determined that it was appropriate to 
publish an IRFA to inquire into the impact of the proposed rule on 
small entities. Based on the IRFA set forth in the Commission's NPRM, a 
review of the public comments submitted in response to that notice and 
the workshop notice, and the discussions from the Workshop itself, the 
Commission submits this FRFA. This document serves as notice to the 
Small Business Administration of the agency's certification of no 
significant impact.

A. Need for and Objectives of the Final Rule

    The Commission has concluded that millions of American consumers in 
need of corrective vision wear are not receiving their eyeglass 
prescriptions after visiting their prescriber. It has also concluded 
that a rulemaking to add a confirmation-of-prescription-release 
requirement is necessary to increase the number of patients who receive 
their prescriptions, to inform patients of the Rule and of their right 
to their prescriptions, and to ensure the separation of eye examination 
and eyeglass dispensing, which fosters a competitive marketplace for 
eyeglasses. The Commission notes that prescribers who currently comply 
with the automatic-release provision of the Rule may presently face a 
competitive disadvantage because of widespread non-compliance by other 
prescribers. This creates an unlevel playing field and undermines fair 
competition. In addition, the Commission expects that this final rule 
will: reduce the number of seller requests to prescribers for eyeglass 
prescriptions; improve the Commission's ability to monitor overall 
compliance and target enforcement actions; reduce evidentiary issues, 
complaints, and disputes between prescribers and consumers; and bring 
the Eyeglass Rule into congruence with the confirmation-of-
prescription-release requirements of the Contact Lens Rule, reducing 
confusion for prescribers and consumers, and easing compliance and 
enforcement for both rules.

B. Significant Issues Raised by Public Comments in Response to the IRFA 
and the Agency's Response, Including Any Changes Made in the Final Rule

    In crafting the final rule, the Commission carefully considered the 
comments received throughout the Rule

[[Page 60773]]

review process. This document contains a detailed discussion of the 
comments received by the Commission and the Commission's response to 
those comments. The Commission did not receive any comment from the 
Chief Counsel for Advocacy of the Small Business Administration.
    The Commission received 47 comments in response to the NPRM and 
Workshop notices. Some of the comments, from prescribers and prescriber 
groups, strongly opposed the confirmation-of-prescription-release 
requirement indicating that such a change was not needed or would be 
burdensome to comply with. Specifically, those commenters stated that 
there was not a compliance problem with the Eyeglass Rule's automatic-
release provision and the confirmation requirement was therefore an 
attempt to ``fix something that was not broken.'' Some also commented 
that the Rule changes, if finalized, would add a burden to small 
business optometry practices that already are enduring financial 
challenges and staffing issues. A few commenters contended that 
compliance with the proposed amendments would take longer than the 
Commission estimated in its NPRM, as demonstrated by the amount of time 
it currently takes prescribers to comply with the existing Contact Lens 
Rule requirements that are similar to those proposed for the Eyeglass 
Rule.
    In contrast to the position expressed above, commenters from NAROC 
said that it is their understanding--based on responses from their 
prescriber members--that compliance with the current Contact Lens Rule 
confirmation-of-prescription-release requirement is occurring with 
little or no disruption or expense.\484\ And as explained in the PRA 
section of this document, the Commission has concerns about the 
reliability of some of the evidence, cited by those critical of the 
Rule's confirmation proposal, as to the burden of the existing contact 
lens confirmation requirement. The Commission did not ignore or dismiss 
any comments and evidence outright, however, and evaluated the 
evidentiary record as a whole in making a final determination.
    The Commission is sensitive to the additional burden or cost that 
this final rule imposes on businesses. However, after weighing all of 
the comments and evidence, it finds that this final rule will provide 
many benefits with a relatively small burden or cost. In particular, 
the Commission determines that the potential benefit of increasing the 
number of patients in possession of their eyeglass prescriptions is 
substantial: namely, increased flexibility and choice for consumers; 
increased competition among eyeglass sellers; a reduced likelihood of 
errors associated with incorrect, invalid, and expired prescriptions, 
and consequently, improved patient safety; and an improved ability for 
the Commission to enforce and monitor prescriber compliance with the 
Rule's prescription-release requirements. The Commission concludes that 
revising the existing remedy of automatic prescription release by 
adding the confirmation-of-prescription-release mechanism is necessary 
and beneficial due to demonstrated failures of prescribers to comply 
with the automatic-release remedy, and to ensure the separation of eye 
examination and eyeglass dispensing, which engenders a competitive 
marketplace for eyeglasses. As a result, this final rule adopts the 
amendments proposed in the NPRM with the modifications discussed in 
this document.
    In response to comments that the Commission, in its NPRM, 
underestimated the amount of time it takes to comply with the CLR 
confirmation-of-prescription-release requirements, and for other 
reasons noted in the PRA section of this document, the Commission 
increased its time estimate for complying with the new 
requirements.\485\

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

    This final rule applies to eyeglass prescribers, and many 
prescribers will fall into the category of small entities (e.g., 
offices of optometrists with $9 million or less in annual 
receipts).\486\ Determining a precise estimate of the number of small 
entities covered by the Rule's prescription release requirements is not 
readily feasible because most prescribers' offices do not release the 
underlying revenue information necessary to make this determination. In 
the NPRM, the Commission sought comment on the number or nature of 
small business entities for which the proposed amendments would have a 
significant impact.\487\ In response, the AOA commented that ``doctors 
of optometry reported collecting $826,612, on average, in gross 
receipts in 2021.'' The AOA also stated that 91.9% of optometry 
practices have fewer than 25 employees.\488\ Based on the AOA comment, 
and staff's knowledge of the eye care industry, including meetings with 
industry members and a review of industry publications, staff expects 
that a substantial number of these entities likely qualify as small 
businesses.\489\

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

    The final rule will impose a confirmation-of-prescription-release 
requirement on all optometrists or ophthalmologists who have a direct 
or indirect financial interest in the sale of eyewear. If a paper copy 
of the prescription was provided to the patient, the prescriber must 
request that the patient acknowledge receipt of the prescription by 
signing a separate statement on paper or in a digital format confirming 
receipt of the prescription. If a digital copy of the prescription was 
provided to the patient, the prescriber must retain evidence that such 
prescription was sent, received or made accessible, downloadable, and 
printable. Prescribers are required to maintain the records or evidence 
associated with the confirmation of prescription release, or digital 
delivery of the prescription for at least three years. In addition, if 
a prescriber elects to provide a digital copy of the prescription to 
comply with the Rule, the prescriber is required to identify to the 
patient the specific method or methods of electronic delivery that they 
will use and to obtain the patient's verifiable affirmative consent to 
receive a digital copy through the identified method or methods. The 
prescriber must maintain records or evidence of the patient's 
affirmative consent for at least three years.
    As discussed in section C of section IX., Final Regulatory Analysis 
and Regulatory Flexibility Act Analysis, we assume that many of the 
estimated 43,000 active optometrists and 18,000 active ophthalmologists 
fall within the definition of a small entity. As discussed in the PRA 
section of this document, we estimate that prescribers' office staff 
perform the task of collecting patient signatures on confirmations and 
digital-release consents, as well as the labor pertaining to printing, 
scanning, and storing of both documents. Prescribers' offices will have 
to train staff on, and set up procedures for complying with, the new 
requirements of the Eyeglass Rule. However, as discussed in the PRA 
section of this document, prescribers likely have forms and systems in 
place to maintain confirmation records already, since they already must 
comply with the similar confirmation requirement of the Contact

[[Page 60774]]

Lens Rule, and may need make only minor adjustments to accommodate 
confirmations for eyeglasses prescriptions.

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

    Commenters at the ANPR stage recommended, as alternatives to the 
signed acknowledgment proposal, conspicuous signage declaring 
consumers' right to a copy of their prescription, or an eye care 
patients' bill of rights notifying consumers of their rights under the 
Rule. As explained in the NPRM, the Commission ultimately decided 
against a signage provision, after determining that the benefits were 
limited and that requiring signage would be significantly less 
effective at ensuring contact lens prescription release than requiring 
a written patient confirmation.\490\ As explained in the NPRM, the 
Commission also decided against another proposed alternative, an eye 
care patients' bill of rights, for reasons including that the bill of 
rights proposal does not require the type of prescriber recordkeeping 
that would allow for better Rule monitoring and enforcement, and would 
not help resolve disputes between patients and prescribers over whether 
a prescription had been released.\491\
    In an attempt to minimize the burdens associated with the 
confirmation-of-prescription-release requirement, the Rule provides 
prescribers with different compliance options depending on whether they 
release a paper or digital copy of the prescription, and provides one-
sentence sample language that prescribers can elect to use should they 
release paper copies of prescriptions. Moreover, this amendment aligns 
with the prescription-release-related provisions of the Contact Lens 
Rule, thereby reducing the confusion and complexity that might arise 
for consumers and prescribers from having different confirmation-of-
prescription-release requirements for contact lens and eyeglass 
prescriptions. In addition, the marginal cost of the amendment to the 
Eyeglass Rule should be relatively low because the Contact Lens Rule 
already requires prescribers to obtain confirmation of prescription 
release and to maintain records of such. Some prescribers likely have 
forms and systems in place already, which may need only minor 
adjustments to accommodate confirmations for eyeglass prescriptions.
    The Commission also adopts the proposed exemption to the 
confirmation-of-prescription-release requirements for prescribers who 
do not have a direct or indirect financial interest in the sale of 
eyeglasses as Sec.  456.4(c).\492\ The purpose of such an exemption is 
to reduce the burden on prescribers who do not sell lenses.

X. Congressional Review Act

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

List of Subjects in 16 CFR Part 456

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

    For the reasons stated in the preamble, the Federal Trade 
Commission amends 16 CFR part 456 as follows:

PART 456--OPHTHALMIC PRACTICE RULES (EYEGLASS RULE)

0
1. The authority citation for part 456 is revised to read as follows:

    Authority: 15 U.S.C. 57a.

0
2. Amend Sec.  456.1 by revising paragraphs (a), (b), (d), (e) and (g) 
to read as follows:


Sec.  456.1  Definitions.

    (a) A patient is any person who has had a refractive eye 
examination.
    (b) A refractive eye examination is the process of determining the 
refractive condition of a person's eyes or the presence of any visual 
anomaly by the use of objective or subjective tests.
* * * * *
    (d) Ophthalmic services are the measuring, fitting, and adjusting 
of ophthalmic goods subsequent to a refractive eye examination.
    (e) An ophthalmologist is any Doctor of Medicine or Osteopathy who 
performs refractive eye examinations.
* * * * *
    (g) A prescription is the written specifications for lenses for 
eyeglasses which are derived from a refractive eye examination, 
including all of the information specified by State law, if any, 
necessary to obtain lenses for eyeglasses.

0
3. Revise Sec.  456.2 to read as follows:


Sec.  456.2  Separation of examination and dispensing.

    It is an unfair act or practice for an ophthalmologist or 
optometrist to:
    (a)(1) Fail to provide to the patient one copy of the patient's 
prescription immediately after the refractive eye examination is 
completed and before offering to sell the patient ophthalmic goods, 
whether or not the prescription is requested by the patient. Such 
prescription shall be provided:
    (i) On paper; or
    (ii) In a digital format that can be accessed, downloaded, and 
printed by the patient, after obtaining verifiable affirmative consent, 
pursuant to Sec.  456.3.
    (2) Provided: An ophthalmologist or optometrist may refuse to give 
the patient a copy of the patient's prescription until the patient has 
paid for the refractive eye examination, but only if that 
ophthalmologist or optometrist would have required immediate payment 
from that patient had the examination revealed that no ophthalmic goods 
were required. For purposes of the preceding sentence, the presentation 
of proof of insurance coverage for that service shall be deemed to be a 
payment;
    (b) Condition the availability of a refractive eye examination to 
any person on a requirement that the patient agree to purchase any 
ophthalmic goods from the ophthalmologist or optometrist;
    (c) Charge the patient any fee in addition to the ophthalmologist's 
or optometrist's refractive eye examination fee as a condition to 
releasing the prescription to the patient. Provided: An ophthalmologist 
or optometrist may charge an additional fee for verifying ophthalmic 
goods dispensed by another seller when the additional fee is imposed at 
the time the verification is performed; or
    (d) Place on the prescription, or require the patient to sign, or 
deliver to the patient a form or notice waiving or disclaiming the 
liability or responsibility of the ophthalmologist or optometrist for 
the accuracy of the refractive eye examination or the accuracy of the 
ophthalmic goods and services dispensed by another seller.


Sec. Sec.  456.3 through 456.5  [Redesignated as Sec. Sec.  456.5 
through 456.7]

0
4. Redesignate Sec. Sec.  456.3 through 456.5 as Sec. Sec.  456.5 
through 456.7, respectively.

0
5. Add new Sec.  456.3 to read as follows:


Sec.  456.3  Verifiable affirmative consent to providing the 
prescription in a digital format.

    For a prescription copy provided in a digital format, the 
prescriber shall:
    (a) Identify to the patient the specific method or methods of 
electronic delivery that will be used, such as text message, electronic 
mail, or an online patient portal;
    (b) Obtain, on paper or in a digital format, the patient's 
verifiable affirmative consent to receive a digital

[[Page 60775]]

copy through the identified method or methods; and
    (c) Maintain records or evidence of a patient's affirmative consent 
for a period of not less than three years. Such records or evidence 
shall be available for inspection by the Federal Trade Commission, its 
employees, and its representatives.

0
6. Add new Sec.  456.4 to read as follows:


Sec.  456.4  Confirmation of prescription release.

    (a)(1) Upon completion of a refractive eye examination, and after 
providing a copy of the prescription to the patient, the prescriber 
shall do one of the following:
    (i) If a paper copy of the prescription was provided to the 
patient, request that the patient acknowledge receipt of the 
prescription by signing a separate statement on paper or in a digital 
format confirming receipt of the prescription; or
    (ii) If a digital copy of the prescription was provided to the 
patient (via methods including an online portal, electronic mail, or 
text message, and pursuant to Sec.  456.3), retain evidence that such 
prescription was sent, received, or made accessible, downloadable, and 
printable.
    (2) If the prescriber elects to confirm prescription release via 
paragraph (a)(1)(i) of this section, the prescriber may, but is not 
required to, use the statement, ``My eye care professional provided me 
with a copy of my prescription at the completion of my examination'' to 
satisfy the requirement.
    (3) In the event the patient declines to sign a confirmation 
requested under paragraph (a)(1)(i) of this section, the prescriber 
shall note the patient's refusal on the document and sign it.
    (b) A prescriber shall maintain the records or evidence required 
under paragraph (a) of this section for a period of not less than three 
years. Such records or evidence shall be available for inspection by 
the Federal Trade Commission, its employees, and its representatives.
    (c) Paragraphs (a) and (b) of this section shall not apply to 
prescribers who do not have a direct or indirect financial interest in 
the sale of eye wear, including, but not limited to, through an 
association, affiliation, or co-location with an optical dispenser.
* * * * *

    By direction of the Commission.
April J. Tabor,
Secretary.

Endnotes

    \1\ 16 CFR 456.2(a). A prescriber may withhold a patient's 
prescription until the patient has paid for the eye examination, but 
only if the prescriber would have required immediate payment if the 
examination had revealed that no ophthalmic goods were needed. Id. 
The Rule defines an ``eye examination'' as ``the process of 
determining the refractive condition of a person's eyes or the 
presence of any visual anomaly by the use of objective or subjective 
tests.'' 16 CFR 456.1. The Commission is changing this term in the 
final rule text to ``refractive eye examination,'' in order to make 
it more precise, and differentiate between eye health exams and 
refractive exams. See infra section VI, Final Rule Regarding ``Eye 
Examination'' Terminology. However, the meaning of the defined term 
remains the same, and since it has previously been referred to as 
``eye exam'' or ``eye examination''--including by commenters--it is 
frequently referred to as such throughout the SBP.
    \2\ 16 CFR 456.2(c).
    \3\ 16 CFR 456.1(g).
    \4\ 16 CFR 456.2(b). The Rule thereby also prohibits 
conditioning the release of the prescription on the requirement that 
the patient purchase ophthalmic goods from the ophthalmologist or 
optometrist.
    \5\ 16 CFR 456.2(d).
    \6\ 16 CFR 456.2.
    \7\ 16 CFR part 192 (rescinded); see also ``Staff Report on 
Advertising of Ophthalmic Goods and Services and Proposed Trade 
Regulation Rule,'' at 235-36 (May 1977), https://www.ftc.gov/reports/staff-report-advertising-ophthalmic-goods-services-proposed-trade-regulation-rule-16-cfr-part-456 [hereinafter Eyeglass I 
Report].
    \8\ See Eyeglass I Report, supra note 7, at 240-48 (detailing 
myriad accounts of prescribers refusing to release eyeglass 
prescriptions to their patients); see also Final Trade Regulation 
Rule, Advertising of Ophthalmic Goods and Services, 43 FR 23992, 
23998 (June 2, 1978) [hereinafter Eyeglass I Rule] (finding that in 
nearly every survey of practicing optometrists considered in the 
rulemaking record, more than 50% imposed a restriction on the 
availability of eyeglass prescriptions to patients).
    \9\ Eyeglass I Rule, 43 FR 23998, 24007-08.
    \10\ Id. at 24003.
    \11\ Id.
    \12\ Id. at 23998.
    \13\ Am. Optometric Ass'n v. FTC, 626 F.2d 896, 915 (D.C. Cir. 
1980). The Court held that the harm arose by making comparison-
shopping harder, removing seller incentives to advertise, and 
reducing opticians' ability to compete. The Court overturned other 
provisions of the Rule related to bans on State advertising 
restrictions. Id. at 910-11.
    \14\ Id. at 916. Following the court's remand, FTC staff 
conducted additional investigation and recommended the Commission 
seek new comment on whether to keep the automatic-prescription-
release requirement or change it to release-upon-request. Fed. Trade 
Comm'n, State Restrictions on Vision Care Providers: The Effects on 
Consumers (1980), https://www.ftc.gov/reports/state-restrictions-vision-care-providers-effects-consumers-eyeglasses-ii. The 
Commission then sponsored a survey--commonly known as the ``Market 
Facts Study''--to determine to what extent prescribers were 
complying with the Rule. The Study found that only a little more 
than one-third of prescribers were in ``technical compliance'' with 
the Rule's prescription-release requirement, and only 38% of 
consumers knew they were entitled to automatically receive their 
prescription. See Fed. Trade Comm'n, Ophthalmic Practice Rules: 
State Restrictions on Commercial Practice at 256-58 (Oct. 1986), 
https://www.ftc.gov/reports/ophthalmic-practice-rules-state-restrictions-commercial-practice-eyeglasses-ii-report-staff 
[hereinafter Eyeglass II Report]. Following the Market Facts Study, 
the Commission did not take any action to revise the Rule.
    \15\ Eyeglass II Report, supra note 14, at 249.
    \16\ Id. at 249, 274-76.
    \17\ Eyeglass I Rule, 43 FR 23992, 23998.
    \18\ Eyeglass II Report, supra note 14, at 275-76.
    \19\ Report of the Presiding Officer on Proposed Trade 
Regulation Rule: Ophthalmic Practice Rules, Public Record No. 215-63 
(1986), https://www.ftc.gov/reports/report-presiding-officer-proposed-trade-regulation-rule-ophthalmic-practice-rules-eyeglass-rule-16 [hereinafter Presiding Officer's Report].
    \20\ Eyeglass II Rule, 54 FR 10285, 10286-87. In addition to 
relying on the Market Facts Study, hearing testimony, and the 
Presiding Officer's Report, the Commission also cited a survey by 
the American Association of Retired Persons, which found significant 
non-compliance and continued lack of consumer awareness of their 
rights, particularly among older consumers. Id. at 10303 & nn.180 & 
181; see also Eyeglass II Report, supra note 14, at 263 n.682 
(noting that 32% of consumers who did not receive a prescription 
stated that they did not know to ask for one).
    \21\ See Cal. State Bd. of Optometry v. FTC, 910 F.2d 976 (D.C. 
Cir. 1990). The court overturned provisions related to certain State 
laws of optometry, which the court found could not be overridden by 
the FTC without more explicit authority from Congress. Following the 
court decision, in 1992, the Commission reissued the Eyeglass Rule, 
but without the portions declared invalid, and with renumbered 
designations pertaining to prescription release. See Final Trade 
Regulation Rule, Ophthalmic Practice Rules, 57 FR 18822 (May 1, 
1992).
    \22\ Ophthalmic Practice Rules, Request for Comments, 62 FR 
15865, 15867 (Apr. 3, 1997).
    \23\ 15 U.S.C. 7601-7610 (Pub. L. 108-164).
    \24\ Pursuant to the FCLCA, the Commission promulgated the 
Contact Lens Rule (``CLR'') on July 2, 2004. Contact Lens Rule, 
Final Rule, 69 FR 40482 (July 2, 2004) (codified at 16 CFR part 
315).
    \25\ Ophthalmic Practice Rules, Final Rule, 69 FR 5451, 5453 
(Feb. 4, 2004) (``2004 ER''). The Commission also made findings 
that: release of prescriptions enhances consumer choice; no evidence 
had been submitted that the Rule's restrictions on disclaimers and 
waivers were no longer needed; the automatic-release provision 
imposed only a minimal burden on prescribers; and retaining 
automatic release would keep the Eyeglass Rule consistent with the 
automatic-release provision of the Contact Lens Rule, 16 CFR part 
315.

[[Page 60776]]

    \26\ 2004 ER, 69 FR 5453.
    \27\ Id.; see also Contact Lens Rule, Final Rule, 69 FR 40482.
    \28\ 15 U.S.C. 57a(a)(1)(B).
    \29\ 15 U.S.C. 57a(d)(2)(B) (``A substantive amendment to, or 
repeal of, a rule promulgated under subsection (a)(1)(B) shall be 
prescribed, and subject to judicial review, in the same manner as a 
rule prescribed under such subsection.'').
    \30\ 15 U.S.C. 45(n); see also Eyeglass II Rule, 54 FR 10285, 
10287; Letter from the FTC to Hon. Wendell Ford and Hon. John 
Danforth, Committee on Commerce, Science and Transportation, U.S. 
Senate, Commission Statement of Policy on the Scope of Consumer 
Unfairness Jurisdiction (Dec. 17, 1980), appended to Int'l Harvester 
Co., 104 F.T.C. 949, 1070, 1073 (1984) (also referred to as ``FTC 
Policy Statement on Unfairness'': https://www.ftc.gov/legal-library/browse/ftc-policy-statement-unfairness).
    \31\ 15 U.S.C. 57a(b)(3).
    \32\ 15 U.S.C. 57a(b)(3)(B).
    \33\ Ophthalmic Practice Rules, Final Trade Regulation Rule, 
Statement of Basis and Purpose, 54 FR 10285, 10288 (1989) (citing 
Credit Practices Rule, Statement of Basis and Purpose, 49 FR 7740, 
7742 (1980)).
    \34\ See Ophthalmic Practice Rules, Final Trade Regulation Rule, 
Statement of Basis and Purpose, 54 FR 10288.
    \35\ Id.
    \36\ Id.
    \37\ Am. Fin. Servs. Ass'n v. FTC, 767 F.2d 957, 988 (D.C. Cir. 
1985) (quoting Jacob Siegel Co. v. FTC, 327 U.S. 608, 612-13 
(1946)).
    \38\ Contact Lens Rule, Request for Comment, 80 FR 53272 (Sept. 
3, 2015) [hereinafter CLR RFC].
    \39\ Ophthalmic Practice Rules (Eyeglass Rule), Advance Notice 
of Proposed Rulemaking; Request for Comment, 80 FR 53274 (Sept. 3, 
2015) [hereinafter ANPR].
    \40\ ANPR, 80 FR 53276.
    \41\ The public comments responding to the ANPR are posted on 
Regulations.gov at https://www.regulations.gov/document/FTC-2015-0095-0001 (ANPR Comments). Regulations.gov has assigned each comment 
an identification number appearing after the name of the commenter. 
This final rule cites comments using the last name of the individual 
submitter, or the name of the organization and the individual within 
the organization who submitted the comment, along with the last four 
digits of the comment identification number assigned by 
Regulations.gov. For instance, the full comment number assigned by 
Regulations.gov to the comment submitted by an individual named 
Publi is FTC-2015-0095-0040. In this document, that comment is cited 
as ``Publi (ANPR Comment #0040).'' This SBP will use this same 
identification method when discussing comments submitted in response 
to other rulemaking notices.
    \42\ See, e.g., Opticians Association of Virginia (ANPR Comment 
#0647 submitted by Nelms) (stating that patients are led into the 
dispensary before paying for their exam and requesting the Rule be 
amended to include language that the prescription be given to the 
patient without additional sales pressure or intimidation); Burchell 
(ANPR Comment #0866); National Association of Optometrists and 
Opticians (``NAOO'') (ANPR Comment #0748 submitted by Cutler); 
Professional Opticians of Florida (ANPR Comment #0803 submitted by 
Couch). Other commenters more generally stated their support for the 
Rule. See Publi (ANPR Comment #0040); Santini (ANPR Comment #0047); 
Costa (ANPR Comment #0068); Ellis (ANPR Comment #0189); Hildebrand 
(ANPR Comment #0220); Prevent Blindness (ANPR Comment #0385 
submitted by Parry); DiBlasio (ANPR Comment #0441); Pulido (ANPR 
Comment #0019); Stuart (ANPR Comment #0841).
    \43\ AOA (ANPR Comment #0849 submitted by Peele); see also 
Barnes (ANPR Comment #0043) (stating she complies with the Rule 
although it is unnecessary since any ethical doctor will release a 
non-expired prescription to a patient); Kanevsky (ANPR Comment 
#0364) (optometrist states she and the prescribers she knows comply 
with the Rule).
    \44\ Contact Lens Rule, Notice of Proposed Rulemaking, 81 FR 
88526 (Dec. 7, 2016) [hereinafter CLR NPRM].
    \45\ Contact Lens Rule, Supplemental Notice of Proposed 
Rulemaking, 84 FR 24664 (May 28, 2019) [hereinafter CLR SNPRM].
    \46\ Contact Lens Rule, Final Rule, 85 FR 50668 (Aug. 17, 2020) 
[hereinafter CLR Final Rule].
    \47\ Id. at 50687.
    \48\ Id.
    \49\ 16 CFR 315.3(c).
    \50\ CLR Final Rule, 85 FR 50687.
    \51\ Id. at 50687-88.
    \52\ CLR SNPRM, 84 FR 24668-69; CLR Final Rule, 85 FR 50681-83.
    \53\ CLR Final Rule, 85 FR 50717; 16 CFR 315.2.
    \54\ Ophthalmic Practice Rules (Eyeglass Rule), Notice of 
Proposed Rulemaking, Request for Public Comment, 88 FR 248 (Jan. 3, 
2023) [hereinafter NPRM].
    \55\ The public comments submitted in response to the NPRM are 
available on Regulations.gov at https://www.regulations.gov/document/FTC-2023-0001-0001 (``NPRM Comments''). There are 47 
comments available at this link. Twenty-seven comments were received 
in response to the Commission's NPRM, and 20 comments were submitted 
in response to a subsequent public notice. See infra note 59.
    \56\ Public Workshop Examining Proposed Changes to the 
Ophthalmic Practice Rules (Eyeglass Rule), Public Workshop and 
Request for Public Comment, 88 FR 18266 (Mar. 28, 2023) [hereinafter 
WS Notice].
    \57\ Id. at 18268.
    \58\ The workshop transcript (along with the agenda and a video 
recording) is available on the FTC website at https://www.ftc.gov/news-events/events/2023/05/clear-look-eyeglass-rule [hereinafter WS 
Transcript].
    \59\ The public comments submitted in response to the WS Notice 
are available on Regulations.gov at https://www.regulations.gov/document/FTC-2023-0001-0029 [hereinafter WS Comments]. There are 47 
comments available at this link. Twenty-seven comments were received 
in response to the Commission's NPRM, and 20 comments were submitted 
in response to the WS Notice.
    \60\ The 2020 Contact Lens Rulemaking record includes comments 
to the CLR RFC; the CLR NPRM; the Public Workshop Examining Contact 
Lens Marketplace and Analyzing Proposed Changes to the Contact Lens 
Rule, Public Workshop and Request for Public Comment, 82 FR 57889 
(Dec. 8, 2017) [hereinafter CLR WS Notice]; and the CLR SNPRM. 
Public comments received in response to these notices are available 
on Regulations.gov: https://www.regulations.gov/document/FTC-2015-0093-0001 (CLR RFC Comments); https://www.regulations.gov/document/FTC-2016-0098-0001 (CLR NPRM Comments); https://www.regulations.gov/document/FTC-2017-0099-0001 (CLR WS Comments); and https://www.regulations.gov/document/FTC-2019-0041-0001 (CLR SNPRM 
Comments). Regulations.gov has assigned each comment an 
identification number appearing after the name of the commenter. 
This document cites comments using the last name of the individual 
submitter, or the name of the organization and the individual within 
the organization who submitted the comment, along with the last four 
digits of the comment identification number assigned by 
Regulations.gov.
    \61\ The Commission has determined not to disturb that finding, 
even after analyzing comments suggesting it should do so. See 
section II.A, infra.
    \62\ See section II.A.1.a, infra note 126 and text, noting that 
two third-party surveys of eyeglass wearers reveal that the number 
of consumers not receiving their eyeglass prescription automatically 
after a refractive exam ranges from 25.6 million to 55.3 million a 
year (based on the Commission's estimate that 82.5 million consumers 
visit their eye care prescriber for a refractive exam each year). 
These figures are generally consistent with multiple prior surveys 
of contact lens users, which found significant percentages of 
contact lens users were not receiving their prescriptions from their 
prescribers following their exams, and provided an impetus for the 
adoption of a confirmation-of-prescription-release requirement in 
the CLR amendments of 2020. See section II.A.1.a, infra note 124; 
see also CLR Final Rule, 85 FR 50687.
    \63\ See 16 CFR 315.3.
    \64\ This final rule does not revisit some amendments that the 
Commission previously determined not to propose; namely, amending 
the Rule to require prescribers provide additional copies of 
eyeglass prescriptions; to require that prescribers respond to 
third-party seller requests for copies of, or verification of, 
prescriptions; or to set an expiration date for eyeglass 
prescriptions. In the NPRM, the Commission determined it did not 
need to seek further comment on these issues, and explained its 
rationale for not proposing these amendments. See NPRM, 88 FR 266-67 
(additional copy), 271-73 (third-party seller requests), and 277-79 
(expiration date).
    \65\ American Academy of Ophthalmology (``AAO''), ``Eye Health 
Statistics,'' https://www.aao.org/newsroom/eye-health-statistics. 
Estimates as to the number of

[[Page 60777]]

ophthalmologists vary, with some putting the number at closer to 
17,000. Richard Edlow, ``By the Numbers: How Many ODs Are Actually 
Practicing Medical Eyecare,'' Rev. of Optm. Bus. (Nov. 3, 2021), 
https://reviewob.com/by-the-numbers-how-many-ods-are-actually-practicing-medical-eyecare/.
    \66\ In some States, optometrists can prescribe medicine and 
perform certain surgeries. AOA, ``What's a doctor of optometry?'' 
https://www.aoa.org/healthy-eyes/whats-a-doctor-of-optometry?
    \67\ Bureau of Labor Statistics, U.S. Dep't of Labor, 
Occupational Outlook Handbook, Optometrists, https://www.bls.gov/ooh/healthcare/optometrists.htm. Estimates as to the number of 
optometrists vary, with some putting the number at closer to 48,000. 
Edlow, supra note 65.
    \68\ Management & Bus. Acad. for Eye Care Prof'ls, ``Best 
Practices of Spectacle Lens Mgmt'' 2 (2015) (estimating revenue from 
prescription eyewear sales at 44% of total practice revenue, with 
contact lens sales revenue at 16%, eye exam revenue at 21%, and 
medical eye care revenue at 17%), https://files.optometrybusiness.com/Best%20Practices%20Spectacle%20Lenses.pdf, see also infra note 174, 
Lovejoy (WS Transcript at 19) (noting that data he has seen over the 
years shows that between 50-60% of gross revenues for practitioners 
who dispense eyewear is derived from product sales).
    \69\ Id., see also Margery Weinstein, ``Key Practice Metrics: 
Numbers to Track & Grow to Help Speed Practice Recovery,'' Rev. of 
Optm. Bus. (Aug. 5, 2020), https://www.reviewob.com/key-practice-metrics-numbers-to-track-grow-to-speed-practice-recovery/ (noting 
that product sales in 2019 continued to account for the majority of 
gross revenue (54%), with eyewear at 37%) (citing Glimpse & Care 
Credit, ``Independent Optometry Key Performance Metrics: 2019 Trend 
Report'' at 5, 9)).
    \70\ OpticianEDU.org, ``Optician Certification,'' https://www.opticianedu.org/optician-certification/. The Commission has not 
independently verified the precise number of States that currently 
require opticians to obtain licenses.
    \71\ Bureau of Labor Statistics, U.S. Dep't of Labor, 
Occupational Outlook Handbook, Opticians, https://www.bls.gov/ooh/healthcare/opticians-dispensing.htm.
    \72\ Vision Council, ``VisionWatch--The Vision Council Market 
Analysis Report,'' at 17 (Dec. 2019) [hereinafter VisionWatch 
Report].
    \73\ Determining the precise number of adults, and adult 
eyeglass wearers, in the United States at any given time, is not 
possible, and estimates will change every year. According to the 
U.S. Census Bureau, in 2020 there were 258.3 million adults in the 
United States. ``U.S. Census Bureau, Age and Sex Composition: 
2020,'' 2020 Census Briefs (2023), https://www2.census.gov/library/publications/decennial/2020/census-briefs/c2020br-06.pdf. Meanwhile, 
four different surveys of U.S. residents in 2021 and 2022 by The 
Vision Council found that 61-65% of adults wear glasses, which 
equates to approximately 158-168 million adults who wear eyeglasses, 
based on the 2020 census. Vision Council Consumer inSights reports 
2022 Q1, Q2, Q3, Q4. In its NPRM, the Commission used a prior Vision 
Council estimate of 165 million adult eyeglass wearers, NPRM, 88 FR 
252, which is within the 158-168 million range.
    \74\ The Vision Council, Market inSights 2022.
    \75\ The Vision Council, Market inSights 2019-2022.
    \76\ Vision Council Consumer inSights Report Q1 2023 at 23, 42.
    \77\ See Opticians Association of America (NPRM Comment #20) 
(noting that according to Optics Magazine, the online eyewear 
industry will continue to experience a compound annual growth rate 
of 6.96% between 2022 and 2027).
    \78\ Vision Council Consumer inSights Report Q2 2023 at 39, 42.
    \79\ Vision Council Consumer inSights Report Q2 2023 at 41.
    \80\ See, e.g., Practice Tips by First Insight Corporation, 
``How to Calculate and Increase Your Optical Capture Rate,'' (July 
6, 2021), https://www.first-insight.com/blog/calculate-increase-optical-capture-rate/; Eric Rettig, ``How We Increased Frame Capture 
Rate by 20% in 3 Years,'' Rev. of Optm. Bus. (Sept. 7, 2022), 
https://reviewob.com/how-we-increased-frame-capture-rate-20-in-3-years/.
    \81\ Vision Council Market inSights 2022 at 11.
    \82\ Catherine Roberts, ``Get Great Glasses For Way Less,'' 
Consumer Reports, Oct. 2023, at 36.
    \83\ Id.
    \84\ Id.
    \85\ 16 CFR 456.2(a).
    \86\ 16 CFR 456.2; see also Presiding Officer's Report, supra 
note 19, at 17-24, 206.
    \87\ Eyeglass I Rule, 43 FR 23992; Eyeglass II, 54 FR 10302; see 
also Eyeglass I Report, 261, 265. (``[W]ith prescription in hand, 
consumers would be free to seek out the price, quality and other 
features which best suit their needs and capabilities.'' The 
ophthalmic prescription is ``the means by which consumers can 
comparison shop,'' and thus ``[i]f the Commission does not act to 
guarantee consumers their prescriptions, consumers may be unable to 
take full advantage of this competition.'').
    \88\ See 2004 ER, 69 FR 5453.
    \89\ Neilly (WS Transcript at 4-5).
    \90\ Id. at 5.
    \91\ Id.
    \92\ Formerly known as the National Association of Optometrists 
and Opticians, or NAOO.
    \93\ NAROC (NPRM Comment #0024 submitted by Neville).
    \94\ Durkee (NPRM Comment #0015).
    \95\ Michaels (WS Transcript at 14).
    \96\ Id. at 7; see also Cooper (NPMR Comment #0009) (asserting 
that patients are receiving their prescriptions, the problem lies 
with inaccurate filling of these prescriptions by ``unlicensed, 
untrained people'').
    \97\ AAO (NPRM Comment #0027 submitted by Repka).
    \98\ OAA (NPRM Comment #0020 submitted by Allen); AOA (WS 
Comment #0047 submitted by Benner).
    \99\ AOA (NPRM Comment #0023 submitted by Benner).
    \100\ Michaels (WS Transcript at 11).
    \101\ Sanders (WS Comment #0043) (Dr. Sanders' calculation is 
based on comparing his assumptions about the number of complaints 
received by the FTC to his estimate that prescribers perform 236 
million refractions every year, an estimate the FTC has not seen 
evidence supporting); see also Coast Eyes Pllc (WS Comment #0046) 
(``Nothing is broken here. Patients get their prescription without 
conflict. . . . Prescribers are historically >99.9% compliant in the 
market's current state.'') Coast Eyes Pllc is operated by Dr. 
Sanders.
    \102\ AOA (WS Comment #0047 submitted by Benner).
    \103\ While the ophthalmic community has repeatedly stated that 
overall prescriber compliance with prescription release is extremely 
high, the community has not offered the FTC a consumer survey on 
this issue, despite repeated comments from the Commission noting the 
absence of empirical evidence to support their claim of substantial 
compliance, or to rebut the multiple consumer surveys in the record 
which show prescriber non-compliance. See NPRM, 88 FR 260 (``the 
Commission notes, as it did in the CLR Final Rule, that despite 
multiple opportunities and requests for comment since 2015, the 
Commission has yet to find or receive any reliable consumer-survey 
data rebutting or contradicting the submitted findings [showing 
compliance problems] for either contact lens users or eyeglass 
wearers, or establishing (other than anecdotally) that consumers 
consistently receive their prescriptions from prescribers.''). 
Indeed, when suggesting that the Commission consider the NERA 
survey, the AOA referenced the repeated comments from the Commission 
about the lack of survey data evidencing compliance. AOA (WS Comment 
#0047 submitted by Benner).
    \104\ AOA (WS Comment #0047 submitted by Benner).
    \105\ Id. According to Dr. Andrew Stivers from NERA Consulting, 
the survey did not specifically ask about compliance with the Rule's 
automatic-prescription-release requirement because the survey was 
not designed to examine compliance, but rather to examine consumer 
conduct and shopping habits for eyewear and, consequently, explore 
the ongoing need for consumers to possess a copy of their 
prescription. According to Dr. Stivers, whether prescribers are 
automatically providing patients with their prescriptions is not as 
relevant if the manner in which consumers purchase eyewear indicates 
that they don't suffer harm (or as great a harm) from not having 
their prescriptions released automatically. ``I do not address the 
Commission's contention of significant non-compliance with automatic 
release, although the provided evidence suggests a relatively 
limited problem, and does not provide evidence linking such a 
problem to harm today.'' Stivers (NPRM Comment #0018).
    \106\ AOA (WS Comment #0047 submitted by Benner).
    \107\ It is also not certain that there were not more than three 
respondents who mentioned a prescriber's failure to release their 
prescription. According to NERA, due to budgetary constraints, 
responses to open-

[[Page 60778]]

ended questions were not formally coded and reviewed. Rather, NERA 
searched all open-ended responses for variations of the words 
``prescription,'' ``Rx,'' ``had to,'' ``forced,'' ``made to,'' 
``choice,'' and ``pressure.'' AOA (WS Comment #0047 submitted by 
Benner). The three consumers who raised the issue of failure to 
release the prescription were identified via this search. It is 
possible, however, that additional respondents may have referenced a 
prescriber's failure to release prescriptions but used words or 
phrases that did not show up during NERA's targeted search, and the 
Commission did not receive the responses to the open-ended 
questions. This adds to the challenge of ascribing weight to, or 
drawing conclusions from, responses (or the lack of responses) to 
open-ended survey questions.
    \108\ See CLR Final Rule, 85 FR 50676; CLR SNPRM, 84 FR 24674-
75. By some estimates, less than 5% of actual fraud victims file 
complaints, and for consumer complaints about FTC rule violations 
the percentage drops even further, perhaps because filing a 
complaint requires that consumers know what an FTC rule specifies, 
that it has been violated, and how to complain to the FTC about it. 
Id. It has generally been the Commission's experience that while a 
large number of complaints can indicate a rule compliance problem, a 
dearth of complaints does not necessarily indicate that there isn't 
a rule compliance problem.
    \109\ Neilly (WS Transcript at 16).
    \110\ Warby Parker (ANPR Comment #0817 submitted by Kumar). The 
October 2015 SurveyMonkey online survey was comprised of 1,329 
respondents recruited from a sample that was U.S. Census-balanced 
and representative of the national distribution of major demographic 
factors, including age, gender, geography, and income. Respondents 
were not informed of the identity of the survey sponsor. Survey 
respondents who had purchased eyeglasses within the last three years 
(65% of the total respondents) answered questions about prescription 
information, purchase behavior, and prescriber experience. Within 
the set of respondents who had purchased within the last three 
years, 54% had purchased within the last 12 months. There were no 
significant differences in responses regarding automatic 
prescription release between those who had purchased within the last 
year and those who had purchased between one and three years prior 
to the survey. The significant difference in automatic-release 
compliance between optometrists and ophthalmologists may be due to 
the fact that fewer ophthalmologists sell eyeglasses, and might thus 
have less incentive to withhold a consumer's prescription, but the 
survey did not directly explore this issue. See ER NPRM, 88 FR 260 
note 174.
    \111\ Id.
    \112\ ``FCLCA Study, Focus on Prescription (Rx)'' at 2, 9, 
attached as Exhibit B to 1-800 CONTACTS's comment in response to the 
FTC's 2015 Request For Comment (CLR RFC Comment #0555 submitted by 
Williams), https://www.regulations.gov/comment/FTC-2015-0093-0555, 
showing that of 303 eyeglass wearers surveyed, only 61% reported 
receiving a ``hard copy'' of their prescription at their last eye 
exam. Of that 61% who received a copy of the prescription, the poll 
found that 55% were given the copy automatically (in other words, 
approximately 34%--55% of 61%--of the total eyeglass wearers 
surveyed were given a copy in full compliance with the Rule), 31% of 
the 61% were not given a copy automatically but requested their 
prescription and were given it immediately in response (19% of the 
total surveyed), and 14% of the 61% were not given a copy of their 
prescription, asked for it, and were told to call the office or 
return for it at a later time (8.5% of the total surveyed). 39% of 
the total eyeglass users surveyed were not given a copy and did not 
ask for it, and thus never received a copy of their prescription. 
The survey was sponsored by 1-800 CONTACTS but conducted by an 
independent third-party polling firm, SSI, and respondents were not 
informed of the identity of the survey sponsor. As explained infra 
note 124, the Commission has recognized some concerns about the 
methodology used for this survey, particularly the use of the word 
``hard copy,'' and the lack of an ``I don't know'' response option 
for some questions, but believes that the information remains 
strongly suggestive of non-compliance, particularly when viewed in 
conjunction with information from other sources and the absence of 
contradictory data.
    \113\ Id.
    \114\ See Coast Eyes Pllc (WS Comment #0046) (``The `data/
surveys' provided to the FTC that they are guiding their decision on 
come from online retailers who have a HUGE conflict of interest.'').
    \115\ AOA (WS Comment #0047 submitted by Benner) (``We [ ] 
question the FTC deriving much of its eyeglass rulemaking from its 
rulemaking on contact lenses. The eyeglass market and contact lens 
market have unique characteristics.'').
    \116\ Id. (quoting NERA Report). It was also noted that the 
median age of eyeglass patients is likely to be higher than that for 
contact lenses, and older patients are more likely to be confused or 
bothered by the need to sign a confirmation document. Repka (WS 
Transcript at 38-39).
    \117\ AOA (WS Comment #0047 submitted by Benner) at 25 
(``[G]lasses purchasers are 10 percentage points more likely to 
consider other options for where to purchase.'').
    \118\ Id. A primary difference between eyeglass and contact lens 
examinations and prescriptions is that contact lens exams involve a 
lens ``fitting,'' in which consumers try on the lenses, and 
prescriptions are only provided after the fitting is complete. 
Fittings can sometimes entail sending consumers home with a set of 
lenses to try out for a few days, and thus sometimes the prescriber 
will not provide the prescription until after this process. This can 
lead some consumers to think they should have been provided their 
prescriptions when, in fact, the fitting was not yet complete. There 
is no such fitting for eyeglass prescriptions. See also infra note 
123 (discussing how the different processes can affect survey 
results about prescription release).
    \119\ See CLR Final Rule, 85 FR 50675; CLR SNPRM, 84 FR 24673.
    \120\ Warby Parker (ANPR Comment #0817 submitted by Kumar).
    \121\ ``FCLCA Study, Focus on Prescription (Rx)'' at 2, 9, supra 
note 112.
    \122\ In particular, these survey results could not have been 
affected by some consumers erroneously thinking they should have 
received their prescriptions when, in fact, their contact lens 
fitting had not been finalized, since eyeglass prescriptions do not 
entail a fitting, and there is little or no reason for a consumer to 
think their eyeglass prescription had been finalized when, in fact, 
it hadn't been.
    \123\ See supra, note 118, explaining the fitting process for 
contact lenses. In theory, the differences between the contact lens 
prescription process and the eyeglass prescription process should 
mean that fewer eyeglass patients are confused as to whether they 
did or did not receive their prescriptions when they were supposed 
to. The fact that the percentage of eyeglass users surveyed who said 
they did not receive their prescriptions is similar, or even higher 
than that of contact lens wearers surveyed adds considerable 
credence to both types of surveys, and provides further support for 
the conclusion that a substantial number of consumers are not 
automatically receiving their prescriptions from prescribers as the 
Eyeglass Rule requires.
    \124\ The results from the individual consumer contact lens 
surveys are as follows: (1) June 2019 survey by Dynata (formerly 
known as SSI) on behalf of 1-800 CONTACTS of 1,011 contact lens 
users found that 21% said they never received their prescriptions 
(1-800 CONTACTS (CLR SNPRM Comment #0135 submitted by Montclair)); 
(2) January 2017 survey by Caravan ORC International on behalf of 
Consumer Action of 2,018 adults found that 31% of contact lens users 
said that at their last eye exam, their doctor did not provide them 
with a paper copy of their prescription (Consumer Action (CLR NPRM 
Comment #2954 submitted by Sherry)); (3) December 2016 survey of 
1,000 contact lens users by SSI on behalf of 1-800 CONTACTS found 
that 24% of consumer respondents said they did not receive their 
prescription (1-800 CONTACTS (CLR NPRM Comment #2738 submitted by 
Williams)); (4) May 2015 SSI survey of 2,000 contact lens wearers 
found that 34% said they did not receive their prescription (1-800 
CONTACTS (CLR RFC Comment #0555 submitted by Williams, Ex. C)); and 
(5) November 2014 SSI survey of 2,000 contact lens wearers found 
that 34% said they did not receive their prescription (1-800 
CONTACTS (CLR RFC Comment #0555 submitted by Williams, Ex. C)). As 
noted in the CLR SNPRM, the manner in which a few of the questions 
were phrased in the 2014 and 2015 surveys raised some Commission 
concerns, since some questions were leading, lacked an ``I don't 
know'' response option, and used a term--``hard copy''--which not 
all consumers may understand. The more recent surveys represented an 
improvement because they included an option for respondents to 
acknowledge that they do not recall whether they received their 
prescriptions, and used the term ``paper copy'' rather than ``hard 
copy.'' CLR SNPRM, 84 FR 24672.

[[Page 60779]]

    \125\ See CLR Final Rule, 85 FR 50675.
    \126\ See section I.D.4, supra note 62. Since it is estimated 
that 165 million Americans regularly wear prescription glasses, and 
that each patient visits their eye care prescriber every two years 
for a refractive exam, the number of consumers not receiving their 
prescription automatically could be as high as 55.3 million a year, 
based on the Survey Sampling International survey, or 25.6 million, 
based on the SurveyMonkey poll. Multiple surveys in the record of 
contact lens users find similar non-compliance with prescription 
release requirements.
    \127\ Eyeglass I Rule, 43 FR 24003 (``[I]t is the Commission's 
finding that the failure to release ophthalmic prescriptions and 
related practices are unfair acts or practices,'' and such practices 
``offend public policy in that they deny consumers the ability to 
effectively use available information and inhibit the functioning of 
the competitive market model.'').
    \128\ NAROC (NPRM Comment #0024 submitted by Neville).
    \129\ NAROC (WS Comment #0049 submitted by Neville).
    \130\ Lovejoy (WS Transcript at 14).
    \131\ 1-800 CONTACTS (NPRM Comment #0025 submitted by 
Montclair); see also Durkee (NPRM Comment #15) (calling it a 
``borderline unethical practice'' not to automatically release 
prescriptions, and favoring more robust enforcement of the existing 
automatic-release requirement rather than adding a confirmation 
requirement.)
    \132\ Anonymous (WS Comment #0030).
    \133\ Brown (WS Transcript at 13).
    \134\ Id.
    \135\ Aceto (WS Transcript at 45-46).
    \136\ Beatty (WS Transcript at 46).
    \137\ Dr. Stivers, a former Deputy Director for Consumer 
Protection in the FTC's Bureau of Economics, now an economics 
consultant with NERA, submitted a comment (NPRM Comment #0018) in 
response to the NPRM. That comment, and his research into consumer 
experience with eyeglass purchases, was sponsored by the American 
Optometric Association. His appearance as a workshop panelist, 
however, was on his own behalf.
    \138\ Stivers (WS Transcript at 17).
    \139\ Id. at 18-19; see also Beatty (WS Transcript at 46) 
(noting that many patients are given a copy but do not still have it 
later on when they need it. And therefore he recommends merely 
ensuring that patients can request a copy of their prescription and 
access it electronically).
    \140\ Stivers (WS Transcript at 10, 17); Stivers (NPRM Comment 
#0018).
    \141\ Stivers (NPRM Comment #0018).
    \142\ Id.
    \143\ Id.
    \144\ Id; see also Stivers (WS Transcript at 12) (``[T]he big 
thing that has really changed is the ability of consumers to find 
prices, to shop to find competitors, before they even leave their 
house. Before the internet, before good information availability, 
really the only way to price compare, if there was also these 
advertising restrictions was to actually go to the 
establishment.''); Montaquila (WS Transcript at 32) (stating that 
people often come to his office knowing beforehand where they plan 
to purchase eyewear); Michaels (WS Transcript at 14) (agreeing that 
most patients today are evaluating their options before they wind up 
in a brick-and-mortar establishment). But see Michaels (WS 
Transcript at 13) (noting that many patients come in for an eye 
health examination even if they do not think they need glasses, and 
thus would not have decided beforehand where to purchase).
    \145\ Stivers (NPRM Comment #0018).
    \146\ Id.
    \147\ AOA (WS Comment #0047 submitted by Benner) (quoting NERA 
report).
    \148\ Id.
    \149\ Id.
    \150\ Id. (``Consumer emphasis on convenience suggests that 
consumers likely consider both where to get an exam and where they 
want to shop for glasses ahead of time for an efficient shopping 
experience.'') (quoting NERA survey).
    \151\ Stivers (WS Transcript at 20).
    \152\ Some prescribers are known to engage in a practice 
referred to as ``prescribing from the chair,'' in which prescribers 
recommend certain eyewear purchases to patients while the patients 
are still in the exam room. This is touted as a means of increasing 
prescribers' eyewear-sale capture rate. See, e.g., Dr. Gayle 
Karanges, ``The 4 Most Powerful Ways I Prescribe from the Chair and 
Contribute to an 82% Eyewear Capture Rate,'' Rev.of Optm. Bus. (Apr. 
7, 2021) (``Patients often view doctors, including optometrists, as 
authority figures. With that status, you have an opportunity to 
influence patients in their decision to follow your treatment plan 
and purchase the eyewear you have prescribed.''), https://reviewob.com/the-4-most-powerful-ways-i-prescribe-from-the-chair-contribute-to-an-82-eyewear-capture-rate/; Practice Tips by First 
Insight Corporation, ``How to Calculate and Increase Your Optical 
Capture Rate,'' Jul. 6, 2021 (describing how one doctor ``recommends 
and prescribes the eyewear needs while the patient is still in the 
exam chair . . . [and] then invites and guides the patient to the 
optical department, introducing the eyewear layout''), https://www.first-insight.com/blog/calculate-increase-optical-capture-rate/. 
The FTC is unaware how widespread this practice is, but it has 
concerns that such practices can further blur the line between 
medical practice and retail sales, and increase the risk that 
patients may feel undue pressure to purchase eyewear from their 
prescriber.
    \153\ Michaels (WS Transcript at 13).
    \154\ As an example, surveys from The Vision Council have found 
that 83% of consumers who recently had an eye exam and bought 
glasses said they purchased the glasses from their prescriber. The 
Vision Council, Consumer inSights Q1 2022. One interpretation of 
this might be that only 17% of consumers benefit from having a copy 
of their prescription with which to shop elsewhere. This seems 
supported by the NERA survey showing convenience is the most 
important factor in a consumer's decision as to where to buy 
glasses. On the other hand, another interpretation is that 83% of 
consumers buy glasses from their prescriber because many were not 
given their prescription, and they either felt uncomfortable 
demanding it or did not know that they could. This interpretation 
could also be supported by the NERA survey, since the survey found 
that price is the second-most important factor for consumers 
deciding where to purchase glasses, and buying glasses from a 
prescriber is often more expensive than other options. Because so 
many consumers do not currently receive their prescription after 
each exam, looking to their current conduct and behavior to 
determine what would happen if they did receive their prescription 
involves a great degree of speculation.
    \155\ See, e.g., Lovejoy (WS Transcript at 15); National 
Taxpayers Union (NPRM Comment #0028 submitted by Sepp) (stating that 
the Eyeglass Rule has been a huge ``boon'' to competition in the 
marketplace).
    \156\ Lovejoy (WS Transcript at 15).
    \157\ Eyeglass I Rule, 43 FR 24003 (declaring that Rule Sec.  
456.7 (now Sec.  456.2), which provides it is an unfair act or 
practice for a refractionist to fail to release a prescription 
immediately after the eye examination is completed, is justified 
``both as a specific delineation of an unfair act or practice as 
well as a remedy to implement the right to advertise.'').
    \158\ See, e.g., Montaquila (WS Transcript at 32) (patients 
already understand what their choices are before they even come in 
for an exam); Michaels (WS Transcript at 14) (noting that most 
patients seem to be evaluating their purchase options before they 
visit their prescriber).
    \159\ See, e.g., Neilly (WS Transcript at 16) (``Before I got 
this notification [about the Eyeglass Rule workshop], I wasn't even 
aware of an eyeglass rule.''); Anonymous (WS Comment #0030) (``Being 
able to have a prescription in your hands as soon as the examination 
is done would be very beneficial.'').
    \160\ Brown (WS Transcript at 17). Dr. Stivers noted in a 
comment that a Commission-sponsored survey in 1981 (the Market Facts 
Survey) found that a significant percentage of consumers, even then, 
were aware that they did not have to buy eyeglasses from their 
examining eye doctor and could ask for their prescription. Stivers 
(NPRM Comment #0018) at 9. This is not incorrect (the Market Facts 
Survey results indicated that ``a large majority of consumers are 
knowledgeable enough to request an eyeglass prescriptions if they 
want one,'' Eyeglass II Report, supra note 14, at 262), but it 
should be noted that another survey conducted around that time (in 
1985, by the American Association of Retired People) found that 83% 
of consumers--particularly the elderly--remained unaware of their 
right to ask for their prescription. Presiding Officer's Report at 
22. It may also be worth noting that the format and phrasing of the 
Market Facts Survey questions may have been flawed (and came under 
criticism) because consumers were simply asked whether it was true 
or false that ``once a person decides where to have his eye 
examined, he must purchase his eyeglasses from his doctor,'' 
creating the possibility that some consumers answered ``false'' not 
because they understood they were free to take their prescription 
and shop elsewhere, but rather because they knew they

[[Page 60780]]

could not be forced to buy eyeglasses if they didn't want to. 
Eyeglass II Report, supra note 14, at 259-61. The Commission, after 
reviewing both the Market Facts and AARP surveys, and other evidence 
in the record, ultimately concluded at that time that ``there 
continues to be a lack of consumer awareness about prescription 
rights.'' Eyeglass II, 54 FR 10303. The two surveys are now roughly 
40 years old, and more recent surveys show that many consumers are 
not fully aware of their prescription rights. See infra notes 161-
163 and text.
    \161\ As with the SSI survey referenced above, the 2015 survey 
performed on behalf of 1-800 CONTACTS was submitted during the 
Contact Lens Rule review, but it was a poll of eyeglass wearers and 
is therefore on point. 1-800 CONTACTS (CLR NPRM Comment #2738 
submitted by Williams). As noted during the Contact Lens Review, the 
manner in which the consumer awareness questions were phrased in the 
survey submitted by 1-800 CONTACTS did raise some concerns about the 
weight that should be accorded to the results. In particular, the 
questions were leading and used a term--``hard copy''--that some 
consumers might not understand. On the other hand, the question's 
phrasing may have led to under-reporting by consumers who did not 
want to acknowledge that they were unaware of their rights under 
Federal law (this is known as social-desirability bias). See 
Diamond, Reference Guide on Survey Research, in Reference Manual on 
Scientific Evidence, 2nd. ed., 248-64 (Federal Judicial Center 
2000), https://wwws.law.northwestern.edu/faculty/fulltime/diamond/papers/referenceguidesurveyresearch.pdf; Floyd Jackson Fowler, Jr., 
How Unclear Terms Affect Survey Data, The Public Opinion Quarterly 
(Summer 1992), https://www.jstor.org/stable/2749171; see generally, 
Carl A. Latkin, et al., The relationship between social desirability 
bias and self-reports of health, substance use, and social network 
factors among urban substance users in Baltimore, Maryland, 73 
Addictive Behaviors 133-36 (2017), https://www.sciencedirect.com/science/article/abs/pii/S0306460317301752?via%3Dihub (social 
desirability bias is the tendency of survey respondents to answer 
questions in a manner that will be viewed favorably by others, and 
can skew survey results by over-reporting attitudes and behaviors 
that may be considered desirable attributes, while underreporting 
less desirable attributes). Social-desirability bias in this 
instance likely serves to artificially lower the number of patients 
unaware of their right to their prescription. In other words, the 
way the question was phrased could lead to results that make it 
appear that more patients are aware of their rights than is, in 
fact, the case. See ``FCLCA Study, Focus on Prescription (Rx),'' 
attached as Exhibit B to 1-800 CONTACTS (CLR RFC Comment #0555 
submitted by Williams) (One question was phrased, ``Are you aware 
that it is your right under federal law, as a patient to receive a 
hard copy of your contact lens/eye glasses prescription from your 
eye exam provider?'' and the other asked, ``Are you aware of the 
following . . .--Your eye exam provider cannot charge you for an 
actual hard copy of your prescription?'').
    \162\ CLR SNPRM, 84 FR 24675 (citing a Caravan ORC International 
survey submitted by Consumer Action (CLR NPRM Comment #2954 
submitted by Sherry) and SSI survey submitted by 1-800 CONTACTS (CLR 
NPRM Comment #2738 submitted by Williams)).
    \163\ See Consumer Action (CLR NPRM Comment #2954 submitted by 
Sherry) (noting survey results showing that 65% of Hispanics and 63% 
of African Americans were unaware of their prescription rights, 
compared to 58% of white Americans surveyed, and that Hispanics were 
less likely to be given copies of their prescriptions after their 
contact lens exams); National Hispanic Med. Ass'n & League of United 
Latin Am. Citizens (CLR SNPRM Comment #0146 submitted by Benavides) 
(``Our community continually has been victimized and denied their 
prescriptions by prescribers and doctors at a higher rate than most 
other Americans''); League of United Latin Am. Citizens (CLR NPRM 
Comment #2336 submitted by Wilkes) (noting that many ``working 
families'' take time off from work to visit their eye doctor because 
they believe their eye doctor is the only place to buy eyewear).
    \164\ CLR SNPRM, 84 FR 24675; see also supra note 152 and text, 
noting that some prescribers blur the separation between exams and 
retail dispensing as a means of improving their eyeglass sales 
``capture rate.''
    \165\ CLR SNPRM, 84 FR 24675.
    \166\ Id.
    \167\ Am. Fin. Servs. Ass'n v. FTC, 767 F.2d 957, 988 (D.C. Cir. 
1985) (quoting Jacob Siegel Co. v. FTC, 327 U.S. 608, 612-13 
(1946)).
    \168\ 16 CFR 456.2.
    \169\ See Aceto (WS Transcript at 52); Santini (ANPR Comment 
#0047) (prescribers should be required to provide a copy of the 
eyeglass prescription before the consumer is led or enters the 
prescriber's optical dispensary); Opticians Ass'n of VA (ANPR 
Comment #0647 submitted by Nelms) (``More often than should be 
occurring, patients are led into the dispensary before paying for 
the exam, and shown their options for eyewear. We would ask the Rule 
be amended to include language that the prescription must be given 
to the patient on completion of the exam without additional sales 
pressure or intimidation.'').
    \170\ See Practice Tips by First Insight Corporation, ``How to 
Calculate and Increase Your Optical Capture Rate'' (Jul. 6, 2021) 
(describing how one doctor ``recommends and prescribes the eyewear 
needs while the patient is still in the exam chair . . . [and] then 
invites and guides the patient to the optical department, 
introducing the eyewear layout''), https://www.first-insight.com/blog/calculate-increase-optical-capture-rate/; Nicole Lovato, ``3 
Things We Did to Increase Capture Rate by 15%,'' Rev. of Optm. Bus. 
(Oct. 27, 2021) (describing how after each exam visit, the doctor or 
a technician will walk the patient to the optical dispensary to try 
and sell them glasses, and ``pulls out a chair from the table and 
tells the patient, `Have a seat, someone will be right over to get 
you finished up.' It is important to state it this way. If you say 
anything about purchasing it gives the patient an opportunity to say 
they are not interested.''), https://reviewob.com/3-things-we-did-to-increase-capture-rate-by-15/. See also supra notes 80, 152.
    \171\ Botha (WS Transcript at 53).
    \172\ 16 CFR 456.2(a).
    \173\ Eyeglass I Rule, 43 FR 23992. See section I.B, supra 
(discussing the history and purpose of the Rule).
    \174\ In most medical fields, a prescriber is prohibited from 
selling the product that they prescribe so as to prevent potential 
conflicts of interest. See generally Limitation on Certain Physician 
Referrals (commonly known as the ``Stark Law'') 42 U.S.C. 1395nn, 
(prohibiting physician self-referral, including for outpatient 
prescription medications); Anti-Kickback Statute, 42 U.S.C. 1320a-
7b(b) (prohibiting physicians from receiving compensation for a 
prescription referral). While there are a few other medical 
professions apart from eyecare--such as veterinary care--in which 
the prescriber may sell what they prescribe, the Commission is 
unaware of another field in which prescribers generate such a 
substantial share of their income from commercial product sales. See 
Lovejoy (WS Transcript at 19) (``I do think that optometry is unique 
among the healthcare professions in the amount of revenue, the 
percentage of the total revenue that comes from product sales, the 
products that they prescribe. The surveys that I've seen and 
information over the years shows it consistently staying over 50%, 
maybe as high as 55 or 60% of gross revenues comes from product 
sales in the practitioners that are dispensing optometrists.''); 
NAROC (WS Comment #0049 submitted by Neville) (``Private dispensing 
optometrists today still make most of their revenue from selling the 
eyewear that they prescribe. These optometrists have a strong 
incentive to improve the `capture rate' of in-office eyewear sales 
to their patients.'').
    \175\ H.R. Rep. No. 108-318 at 5 (2003); see also Letter from 
Senators Richard Blumenthal and Orrin G. Hatch of the U.S. Senate 
Regarding the Contact Lens Rule Rulemaking Proceeding & the Proposed 
Rule Set Forth in the Notice of Proposed Rulemaking (Aug. 11, 2017), 
https://www.ftc.gov/system/files/filings/initiatives/677/public_comment_from_senators_blumenthal_and_hatch_re_contact_lens_rulemaking.pdf (these comments were made in reference to the contact 
lens marketplace, but the same potential conflict of interest exists 
when eyeglass prescribers also sell eyeglasses to their patients).
    \176\ Eyeglass I Report, supra note 7, at 265.
    \177\ The ophthalmic community and its representative 
associations were once fervent advocates for the ``total vision 
care'' approach to eyecare, and argued that patients received the 
best care when they obtained glasses and contacts from the same eye 
doctor who examined them and determined their prescription. See 
Eyeglass I Report at 236-39. While the AOA no longer publicly 
advocates for ``total vision care,'' some prescribers still 
occasionally comment to the FTC that patients would be best served 
by a total-vision-care approach.
    \178\ See section I.D.5, supra, discussing the benefits of in-
person eyeglass fittings.
    \179\ This is a different situation from patients complaining 
that they did not

[[Page 60781]]

receive their prescription from their prescriber even after paying 
for their exam, or had to ask for their prescription in order to get 
a copy. There is much less room for consumer confusion with respect 
to those types of complaints than for complaints that consumers had 
to pay for their prescription.
    \180\ The majority of patients who go in for an eye exam and 
need new glasses do end up purchasing them from their prescriber. 
According to data from The Vision Council, 83% of consumers surveyed 
who recently had an eye exam and bought glasses said they purchased 
the eyewear from their prescriber. The Vision Council, Consumer 
inSights Q1 2022. This is true even though, on average, prescribers 
charge significantly higher prices for eyeglasses than other 
alternatives such as online eyeglass sellers. The Vision Council, 
Market inSights 2019-2022.
    \181\ 16 CFR 456.2(a).
    \182\ There are situations where a doctor may conduct a 
refractive exam on a patient but then use his or her professional 
judgment to refrain from writing a prescription for corrective 
eyewear. See Lovejoy (WS Transcript at 56) (``[C]onsumers may want a 
prescription when they shouldn't have one [for medical reasons], and 
the potential prescriber, the physician or optometrist, ought to 
have the ability to say, `No, I'm not prescribing eyewear for you 
for the following reasons.' And make a note of that in the 
record.''). In such situations, the prescriber would have no reason 
to offer to sell the patient eyewear and would be prohibited from 
doing so under the Rule.
    \183\ Panelists at the workshop discussed whether greater 
clarity in the Rule could help ensure that patients have their 
prescription in hand before being invited to purchase eyeglasses. 
See Aceto (WS Transcript at 52) (``That's one concern that some of 
our optician members have had some concerns with, and that is at the 
end of the actual doctor's exam, oftentimes they're directed to the 
dispensary just as a matter of course, and they purchase 
[eyeglasses] at the end of the actual [exam]. And the copays, the 
exam fees, the glasses are all taken [together]. Then they said, 
here's your eyeglass prescription. And some of our members have 
asked, is there a way that we could clarify that the prescription 
should come to them at the end of the doctor's experience?'').
    \184\ The Commission realizes that some eye care practices 
advertise a bundle where the consumer pays a fixed price for an eye 
examination and one or more pairs of frames, or complete eyeglasses. 
Such an offer may also be advertised as an opportunity to obtain a 
free eye exam with the purchase of eyeglasses. The amendment to the 
Rule's wording is not intended to change those practices' ability to 
make, and lawfully deliver upon, such offers. However, the 
prescriber must still provide the prescription to the patient before 
offering to sell them eyeglasses. By doing so, the patient should 
have the choice to take advantage of the advertised bundle, or to 
pay the practice's routine cost of an examination and walk away with 
no eyeglasses, but with their prescription. The exam cannot be 
contingent on the purchase of eyeglasses, as stated in the Rule. See 
16 CFR 456.2. The Commission has provided guidance with respect to 
the Contact Lens Rule for similar bundles of eye exams offered with 
contact lenses, instead of eyeglasses. In that context, the 
Commission has stated that a prescriber is not prohibited from 
offering a bundled package of an eye examination and contact lenses, 
provided that consumers have an option to purchase the eye 
examination separately and still receive their prescription. Contact 
Lens Rule, Final Rule, 69 FR 40482, 40494. A similar result is 
appropriate here.
    \185\ CLR SNPRM, 84 FR 24675; Eyeglass I Rule, 43 FR 23998.
    \186\ NPRM, 88 FR 268-69.
    \187\ NPRM, 88 FR 268.
    \188\ Id.
    \189\ Id.
    \190\ CLR Final Rule, 85 FR 50717; 16 CFR 315.2.
    \191\ CLR SNPRM, 84 FR 24668.
    \192\ OAA (NPRM Comment #0020 submitted by Allen) (``OAA 
believes that this revision ensures that the FTC's regulatory 
language is keeping pace with updates in technology.''); 1-800 
CONTACTS (NPRM Comment #0025 submitted by Montclair) (``1-800 also 
supports . . . allowing prescribers to release a prescription in 
digital format with a patient's verifiable affirmative consent to a 
specific method for digital delivery.''); Aceto (WS Transcript at 
42) (``[F]rom the optician standpoint and those who fill the 
prescription, it's sort of brilliant. Because again, we're keeping 
up with our current status of technology. It helps people, it's an 
all about an access type thing, and I think that that's a really, 
really good option.'').
    \193\ AOA (NPRM Comment #0023 submitted by Benner).
    \194\ NAROC (NPRM Comment #0024 submitted by Neville).
    \195\ Anonymous (NPRM Comment #0007) (``Most practices have an 
EMR system that also has a patient portal. Most of these patient 
portals provide access to the eye glass prescription. This new 
`rule' is not necessary. If there is ever a question, the EMR system 
will always have a copy of the prescription available for anyone 
that wants it.''); Anonymous (NPRM Comment #0011) (``In 2009 The 
Hitech Act was passed which assured the use of electronic medical 
records. The EMR (The Electronic Medical Records Mandate) requires 
healthcare providers to convert all medical charts to a digital 
format. Incurring more costs on businesses for storage, paper, ink, 
private and government payroll, etc., is not an [ ] economically 
intelligent idea in a recession driven economy.''); Michaels (WS 
Transcript at 7) (``in my experience, 100% of the prescriptions that 
are coming out of our offices are automatically uploaded 
electronically to a portal the very second that the prescription is 
finalized. . . . That was the most important piece of the MIPS 
program that Medicare had. It mandated that patients get access to 
their portals. And so, in our experience, the vast majority of our 
patients don't want paper copies of the prescription. They want 
electronic copies so that they can have access in their phone and 
access at 2:00 in the morning, whenever they want it.'').
    \196\ Anonymous (NPRM Comment #0006). See also Rosemore (WS 
Comment #0045) (``As an optometrist, the added requirements would be 
a significant burden on my practice. Requiring more paperwork, 
consents, data storage, and time makes the cost of doing business go 
up significantly.'').
    \197\ One workshop participant suggested that prescribers who 
use electronic health records should not be required to transcribe 
an electronic prescription into a handwritten one, as this could 
introduce errors into the prescription. See Montaquila (WS 
Transcript at 22) (``Handwriting prescriptions after generating one 
in an electronic format increases time and cost, and is not risk-
free. Researchers at Weill Cornell Medical College found error rates 
of 30 per 100 written prescriptions, and only seven per 100 
electronic prescriptions. Now, that of course was from medications, 
but I would propose that contact lenses are no less complex when 
written on a sheet of paper.''). The FTC's requirement that patients 
be given the option to receive a paper copy would not necessitate a 
prescription to be converted from an electronic record to a 
handwritten one; instead the prescription could be printed out on 
paper, as was described by other workshop participants. See Hyder 
(WS Transcript at 53) (``If it's coming from the EHMR, I tend to get 
that when I'm checking out because it's being printed someplace 
other than the exam room.'').
    \198\ See, e.g., U.S. Dep't of Health & Human Servs., The Office 
of the National Coordinator for Health Information Technology 
(``ONC''), ``Do I Need to Obtain Consent From My Patients to 
Implement a Patient Portal?,'' https://www.healthit.gov/faq/do-i-need-obtain-consent-my-patients-implement-patient-portal (noting 
that the Health Insurance Portability and Accountability Act 
(``HIPAA'') permits the disclosure of health information to the 
patient without requiring the patient's express consent and that 
portals are ``an excellent way to afford patients access to their 
own information and to encourage them to be active partners in their 
health care.'').
    \199\ CLR SNPRM, 84 FR 24668.
    \200\ U.S. Dep't of Health & Human Servs., ONC, ``Individuals' 
Access and Use of Patient Portals and Smartphone Health Apps, 
2022,'' Data Brief: 69 (2023), https://www.healthit.gov/sites/default/files/2023-10/DB69_IndividualsAccess-UsePatientPortals_508.pdf.
    \201\ Id.
    \202\ National Institutes of Health, National Cancer Institute, 
Health Information National Trends Survey, Hints Brief Number 52, 
``Disparities in Patient Portal Communication, Access, and Use'' 
(2020), https://hints.cancer.gov/docs/Briefs/HINTS_Brief_52.pdf 
(``[S]ignificant disparities exist in patient portal use, with 
underserved groups (including racial and ethnic minorities, those 
with lower socioeconomic status, older individuals, and persons with 
disabilities) using these tools less often.'').
    \203\ Id.
    \204\ U.S. Dep't of Health & Human Servs., ONC, ``Individuals' 
Access and Use of Patient Portals and Smartphone Health Apps, 
2022,'' supra note 200.

[[Page 60782]]

    \205\ See, e.g., Hyder (WS Transcript at 43) (``I would say that 
we're supportive of giving the option for digital prescriptions. But 
again, we would agree with not mandating that every type of digital 
option be available.''); Beatty (WS Transcript at 42) (``I think we 
do have to be careful with how we consider that delivery though. 
Requirements for that delivery to include all of the methods, 
including SMS and MMS, would or could actually produce new burden. 
Not everyone who delivers these things electronically has access to 
an SMS system or an MMS system. And so we'd want to be able to 
provide the possibility of delivering them electronically, but also 
allow for the provider to have the choice of how the electronic 
delivery would occur.'').
    \206\ NAROC (NPRM Comment #0024 submitted by Neville) (``We note 
with approval that the prescriber will not be required to offer a 
digital copy of the prescription, which some prescribers may not be 
able to offer. But we also suspect that those prescribers using 
digital release for contact lenses will likely use it for eyeglass 
prescriptions as well, again, adding efficiency to office 
operations.'').
    \207\ Lovejoy (WS Transcript at 45) (``Well, I do think it is 
easier . . . if a patient can get a prescription through email 
either directly of the prescription itself or to a link to a website 
or a portal where they can obtain it. And anecdotally I've heard 
reports of being able to be standing at the office desk checking out 
and having the prescription emailed to you before you leave the 
office. It's in your iPad or your iPhone and ready to be used 
wherever you might want to use it.''); Hyder (WS Transcript at 45) 
(``I would say that it gives providers more ability to comply, but I 
can't say that we have data to show that it improves compliance.'').
    \208\ NPRM Comment #0006 (``What happens when they access their 
portal and print the prescription off from there? Will our portals 
have to update to require a signature as well?'').
    \209\ Repka (WS Transcript at 26) (``And then if a patient gets 
it in the portal, which in our portal is simple, they just go on if 
they have it, they can download it. They don't actually need to 
provide a signature. So we send a note asking for a signature, and 
we never get those returned because the patient doesn't have to. And 
the modules aren't set up in the EMR to be compliant with that. So 
they get a notification. If they happen to send it back, of course 
they have to print it, sign it, scan it, and then figure out how to 
upload it into the portal. And then the staff have to actually take 
it from the portal and put it into the right record so that it can 
be retained.'').
    \210\ Prescribers are also not required to obtain signed 
confirmations for contact lens prescriptions that are delivered 
digitally, provided the prescriber complied with the CLR's 
requirement for obtaining and storing a record of a patient's 
verifiable affirmative consent to digital delivery. 16 CFR 
315.3(c)(1)(i)(D). Instead, the prescriber need only retain evidence 
that the prescription was sent, received, or made accessible, 
downloadable, and printable--evidence that will typically be 
electronic and automatic via the email, text, or portal method used 
by the prescriber. Id.
    \211\ See section III, infra.
    \212\ Anonymous (NPRM Comment #0006) (``We already have a record 
of the prescription on file for the patient and most EHRs track when 
they are printed out.''); Lovejoy (WS Transcript at 10) (the 
requirement, as proposed, ``sounds like it would not be difficult to 
have a record of the patient receiving access to their prescription 
through [the] portal, so that would not seem like a significant 
burden.'').
    \213\ Lovejoy (WS Transcript at 10).
    \214\ Beatty (WS Transcript at 43) (``So if a portal could 
possibly be confusing, having a website where the patient can enter 
rudimentary data and then get back just the prescription information 
that they were looking for should be acceptable too.'').
    \215\ Montaquila (WS Transcript at 23) (``[The electronic] 
approach is not without challenges. The method requires many steps 
and a secure system for data transmission. Additionally, some 
electronic health record systems cannot automatically transmit the 
eyeglass or contact lens prescription to the patient portal. So when 
a patient requests an electronic copy of their prescription in those 
scenarios, the doctor must first print the prescription, attach it 
to an email, and then send it to the patient. For storage, it is 
possible to attach the information to the patient's medical record, 
but colleagues report that some electronic health record systems 
impose costs to store data over time. So using this method for them 
would increase the doctor's cost in perpetuity.'').
    \216\ Through the 21st Century Cures Act, Congress authorized 
HHS to take action to promote the interoperability of health IT, 
support the use, exchange, and access of electronic health 
information, and limit information blocking. 21st Century Cures Act, 
Public Law 114-255, Title IV (2016). The Cures Act Final Rule, 
promulgated by the U.S. Dep't of Health & Human Servs., ONC, 
requires healthcare providers to enable patient access to enumerated 
classes of data in their electronic health record systems. ONC, 21st 
Century Cures Act: Interoperability, Information Blocking, and the 
ONC Health IT Certification Program, Final Rule, 85 FR 25642 (May 1, 
2020). These data classes include providers' clinical notes and 
information on medications, and the ONC noted in the latest update 
(Version 4 from July 2023) to the United States Core Data for 
Interoperability (USCDI) that the definition of ``clinical tests'' 
includes ``visual acuity exam.'' ONC, HealthIT.gov, Interoperability 
Standards Advisory (ISA), Clinical Tests, USCDI V4, https://www.healthit.gov/isa/uscdi-data-class/clinical-tests#uscdi-v4. While 
this decision may result in consumers having greater access to their 
prescription information in their EHRs, it does not directly impact 
prescribers' obligations for automatic prescription release under 
the Eyeglass Rule.
    \217\ Brown (WS Transcript at 7) (``it is very concerning that 
patients might not understand how to access their prescriptions. 
It's wonderful that patients are . . . requesting or desiring these 
prescriptions to be available to them online. But from the Prevent 
Blindness perspective and the patient's perspective, not every 
single patient is the same. Not everybody has the same access. Not 
everybody has the same broadband capabilities, the same smartphone 
technologies. And a lot of patients lack health literacy that 
encourages us as a completely available use to, or available avenue 
for them to receive access to their prescriptions.''); Aceto (WS 
Transcript at 42) (``My only concern with [technology] is not 
everybody, as we talked about with different clientele and different 
patients and different modalities, not everybody's as well 
versed.''); Hyder (WS Transcript at 45) (``ophthalmology patients 
who are older[--for the] digital option, they may not even want or 
have any idea of how to access [it].'').
    \218\ Brown (WS Transcript at 7) (``So it is encouraging, but it 
seems [] that there's a missed opportunity if patients can access 
their records digitally, but if they're not also given other means 
to access their prescriptions.''); Beatty (WS Transcript at 42) 
(``And so we'd want to be able to provide the possibility of 
delivering [prescriptions] electronically, but also allow for the 
provider to have the choice of how the electronic delivery would 
occur. And then the patient to consent to whether they want that 
electronic delivery or if they would prefer to have a paper 
version.'').
    \219\ Montaquila (WS Transcript at 26) (Once the prescription is 
on the portal, ``we have to then teach them, if they want to use the 
portal, how to find it. They have to go in, they have to log in, 
they have to download it. It's not that difficult to do, but they 
still need the education as you would for any new system you'd use. 
But then we have plenty of patients who say, `I'm not electronic, 
just give me a copy.' '').
    \220\ Aceto (WS Transcript at 45) (``I will say that a good 
amount of the time that we spend oftentimes as opticians is 
sometimes calling for verification. But I do worry that some of 
these other burdensome regulations like the affirmative consent, for 
example, isn't going to change that. Because if [patients] forget 
[the prescription] at home, if they don't have it, we end up 
calling. And I don't know that it's that much of a burden to 
[prescribers]. Because as we've called optometrist's office and 
ophthalmologist's office, I will tell you that without fail because 
of the great work of the FTC since 1978, there hasn't been as much 
pushback as before those rules were instigated.''); Beatty (WS 
Transcript at 46) (``I think that the number of patients who are 
issued a paper prescription only, to just not have it when they need 
it is relatively high. And so a simple request from the patient to 
have a paper copy should they need one I think is a really simple 
request on their side and not really burdensome. I think that as 
long as that prescription is issued at the request and there's an 
electronic version available to that patient, then it should be 
ample.'').
    \221\ The Commission notes that for some telemedicine exams, 
digital delivery might be the only practical way for a prescriber to 
transmit the prescription immediately after the exam; in such cases, 
medical practices may need to obtain patient consent during the 
intake process. If a patient is in a medical office, however, and 
only the prescriber is remote, the office could print a paper copy

[[Page 60783]]

of the prescription for the patient. See Lovejoy (WS Transcript at 
45) (``And more and more we're seeing some of those prescriptions 
being written after a telemedicine eye exam where the doctor and the 
patient are in a real time communication, but the doctor's remote. 
And the only way for the doctor to prescribe and get the 
prescription to the patient is electronically. It can be then 
printed out at the office and the patient can use it either there at 
the location or take it someplace else, but the patient then has 
access to it electronically as well.'').
    \222\ See section II.C., supra.
    \223\ CLR Final Rule, 85 FR 50683.
    \224\ See section VIII.A, infra.
    \225\ The digital delivery provision also does not alter or pre-
empt existing State and Federal requirements pertaining to the 
electronic delivery of records and consumer consent, such as the 
Electronic Signatures in Global and National Commerce Act, 15 U.S.C. 
7001.
    \226\ 45 CFR 164.520; AOA (WS Comment #0047 submitted by Benner) 
(``Greater analysis of the overall burden [of] regulations on 
doctors would also be helpful to inform how best to streamline rule 
changes and explore alternative options, FTC could consider 
mirroring some of the acknowledgement requirements after the 
Department of Health and Human Services (HHS) Notice of Privacy 
Practices which does not require acknowledgment to be obtained at 
every visit. Seeking authorization to provide a prescription 
electronically could follow the same approach.'').
    \227\ Montaquila (WS Transcript at 35) (Allowing the consent 
form to be signed once ``would make it much easier for all of us to 
implement because we could educate [the patient] as to what the 
office policy is, whether that's paper or electronic or a 
combination thereof. It could happen at the outset when they first 
establish their relationship with us and only if we change policy or 
they make a request, because the patients could understand, `I know 
your policy and I'm happy with it.' Or, `I'm not happy with it, I 
want it done a different way.' And that could all be documented when 
we first meet them or at any time at [a] time [of] their choosing. 
So putting it in the patient's hands to have control.'').
    \228\ See, e.g., 45 CFR 164.520(c)(1)(ii) (``No less frequently 
than once every three years, the health plan must notify individuals 
then covered by the plan of the availability of the notice and how 
to obtain the notice.'').
    \229\ For example, consider an instance where a prescriber 
obtains a patient's affirmative consent to digital prescription 
delivery via email in September 2024, and the prescriber relies on 
that consent to email prescriptions until and including the 
patient's September 2028 appointment. In 2029 the prescriber changes 
the digital delivery policy to delivery via patient portal, and the 
consumer signs a new affirmative consent during their annual 2029 
appointment. The prescriber's office should retain the original 
affirmative consent to email delivery at least through September 
2031 (September 2028 appointment plus three years), and should 
retain the 2029 consent to delivery via portal for three years, or 
for as long as the prescriber relies on that consent to provide 
prescriptions via portal, plus another three years.
    \230\ NPRM, 88 FR 268.
    \231\ CLR Final Rule, 85 FR 50682-50684; 16 CFR 315.2.
    \232\ See Office of the Federal Register, Regulatory Drafting 
Guide, Definitions, https://www.archives.gov/federal-register/write/legal-docs/definitions.html (``5. Do not include a substantive rule 
within a definition. A reader can easily miss a rule placed within a 
definition.'').
    \233\ Old Rule Sec. Sec.  456.3, 456.4, and 456.5 are 
redesignated as new Sec. Sec.  456.5, 456.6, and 456.7, 
respectively.
    \234\ 5 U.S.C. 553; 15 U.S.C. 57a(b)(1).
    \235\ See WS Transcript at 27-28, 36; Repka (WS Transcript at 
28) (``The question [ ] was why the EMR companies haven't followed? 
Well, the new rule, it takes time to get a consumer base or a user 
base that goes and asks the big company to prioritize that 
development over 500 other development requests that they get. I 
think we clearly need one because a signature pad or a checkoff box, 
which just rolled out in Epic for procedure consents would make this 
easier.''); Montaquila (WS Transcript at 36) (``You mentioned Epic. 
I worked with one of the first Epic implementations in the country, 
believe it or not, way back. And they have a really good system with 
a signature pad. The system I use now has an iPad. You can open up, 
they can sign on the iPad. But I am talking to other colleagues who 
say that their EHR system has no option similar to this. All of them 
are probably moving in the same direction, right?'').
    \236\ See, e.g., Repka (WS Transcript at 36) (``it still seems 
to me that the EMRs of the future will be able to accept this as an 
electronic signature, that it will store in some fashion other than 
necessarily on a paper that says any of the three things that you've 
had there. So that if there's an option to do that, it would be 
nice. If you still needed it to be on a printable PDF, then not as 
convenient.'').
    \237\ NAROC (NPRM Comment #0024 submitted by Neville). NAROC 
also requested the Commission be open to petitions from prescribers 
to allow additional digital methods of verifications as technology 
evolves and provided examples including the use of a personal 
identification number by the patient in an EHR, a fingerprint, a 
retinal scan, voice recognition or other verifiable consent 
documentation. WS Comment #0049 submitted by Neville. The FTC is 
open to new digital methods of verifications such as biometric data 
so long as the processes are optional, secure, there are methods in 
place to confirm and verify the identity of the signatory, and the 
signatures are designed such that they cannot be used by anyone 
other than their genuine owners.
    \238\ Montaquila (WS Transcript at 23) (``For the approach on 
screen, the consent is obtained on paper, but then other practices 
will use an electronic means to collect that signature.'').
    \239\ CLR NPRM, 81 FR 88535.
    \240\ CLR SNPRM, 84 FR 24667.
    \241\ NPRM, 88 FR 265.
    \242\ See sections I.D.4 supra, IV.C.3 infra.
    \243\ Although prescribers may similarly comply with the CLR by 
obtaining digital signatures, the Commission recognizes that, for 
the time being, the CLR will differ from the Eyeglass Rule by not 
expressly permitting signature collection in a digital format. The 
Commission can amend the CLR to include this express permission 
during its next rule review and, in the meantime, can provide 
clarity to prescribers through guidance materials.
    \244\ Press Release, Fed. Trade Comm'n, FTC Sends Cease and 
Desist Letters to Prescribers Regarding Potential Violations of the 
Commission's Contact Lens Rule (Feb. 21, 2023), https://www.ftc.gov/news-events/news/press-releases/2023/02/ftc-sends-cease-desist-letters-prescribers-regarding-potential-violations-commissions-contact-lens; Press Release, Fed. Trade Comm'n, FTC Sends 37 New 
Cease and Desist Letters Regarding Agency's Eyeglass Rule (Apr. 20, 
2023), https://www.ftc.gov/news-events/news/press-releases/2023/04/ftc-sends-37-new-cease-desist-letters-regarding-agencys-eyeglass-rule.
    \245\ Botha (WS Transcript at 44).
    \246\ Beatty (WS Transcript at 44) (``While I think there are 
things that can be coupled together to decrease the amount of forms 
that a patient is having to sign, I do think that there are certain 
aspects of that intake process that should be separate so that we 
can make sure that the patient is acknowledging things appropriately 
. . . in this case, whether or not we separate the acknowledgement 
for the availability of the prescription.'').
    \247\ See section I.B, supra.
    \248\ Montaquila presentation, FTC Eyeglass Rule Workshop at 7, 
https://www.ftc.gov/system/files/ftc_gov/pdf/Stephen-Montaquila-OD-Presentation.pdf.
    \249\ See NPRM, 88 FR 286 (previously proposed as Sec.  
456.1(h)(2)).
    \250\ NPRM, 88 FR 265.
    \251\ The NPRM proposed to redesignate the provisions currently 
codified at Sec. Sec.  456.3 through 456.5 as Sec. Sec.  456.4 
through 456.6, respectively, and add a new Section 456.3.
    \252\ Id. at 266.
    \253\ Id. at 280.
    \254\ Id. at 280-81.
    \255\ These comments are in addition to the comments detailed 
above on the need for automatic prescription release due to a lack 
of compliance and patient awareness of their rights to a 
prescription. See section II.A, supra.
    \256\ Williams (NPRM Comment #0002) (``This is a great idea and 
will protect patients!''); Wolin (NPRM Comment #0003) (``I support 
the proposed rule changes as a smart and efficient update''); Riffle 
(NPRM Comment #0013) (``I agree with the proposed rule''); Anonymous 
(NPRM Comment #0017) (``I support the proposal to require eye 
doctors to obtain signed confirmation of prescription release.'').
    \257\ NAROC also points out that more prescriptions in the hands 
of consumers might reduce the number of requests for additional 
copies. NPRM Comment #0024 submitted by Neville; WS Comment #0049 
submitted by Neville.
    \258\ NAROC (NPRM Comment #0024 submitted by Neville; WS Comment 
#0049 submitted by Neville).

[[Page 60784]]

    \259\ NAROC (WS Comment #0049 submitted by Neville).
    \260\ Consumer Action (NPRM Comment #0026 submitted by 
McEldowney).
    \261\ NPRM Comment #0028 submitted by Sepp.
    \262\ 1-800 Contacts (NPRM Comment #0025 submitted by 
Montclair).
    \263\ Id. Another commenter stated that he approves of the Rule 
and hopes the Rule is enforced. White (NPRM Comment #0022).
    \264\ NAROC (NPRM Comment #0024 submitted by Neville). It 
encourages the Commission to report on how its access to 
prescribers' confirmation of prescription release has been used and 
whether it can demonstrate that the cost to prescribers associated 
with the confirmations is justified by improved enforcement. Id.
    \265\ WS Transcript at 32-33. See also Consumer Action (NPRM 
Comment #0026 submitted by McEldowney) (``In fact, providers should 
welcome this record-keeping as a way to prove that they are 
following the law if challenged.'').
    \266\ NAROC (WS Comment #0049 submitted by Neville).
    \267\ WS Transcript at 19.
    \268\ WS Comment #0049 submitted by Neville. See also supra note 
174 (citing Lovejoy (WS Transcript at 19) noting the high percentage 
of optometrists' gross revenue that comes from the product sales)).
    \269\ NAROC (WS Comment #0049 submitted by Neville). Consumer 
Action does not believe it is a burden on prescribers to obtain, 
document, and retain a consumer's affirmative receipt of their 
prescription. NPRM Comment #0026 submitted by McEldowney.
    \270\ NAROC (WS Comment #0049 submitted by Neville). At the 
workshop, Joseph Neville said that he's been talking over the last 
two years with their members and they ``said they're not having 
problems [complying] with the Contact Lens Rule.'' WS Transcript at 
28.
    \271\ WS Transcript at 31.
    \272\ National Taxpayers Union (WS Comment #0028).
    \273\ Id.
    \274\ Id. The Commission has not been able to replicate NTU's 
cost calculation. Based on NTU's estimate that a ``modest optometry 
establishment'' might conduct 3000 examinations per year, and using 
the NPRM burden estimate of 10 seconds to obtain a patient's 
confirmation and one minute to store it, the requirement would 
impose an additional paperwork burden on such a practice of 58.3 
hours per year (3,000 x 70 seconds / 60 / 60). Using the NPRM 
estimated wage rates for optometrists and office staff, such an 
additional burden would amount to an incremental burden of 
$1,439.88. However, staff does not know how accurate NTU's estimate 
for a ``modest optometry establishment'' is, and does not possess 
information about typical practices. As explained in this document's 
PRA section, staff based its ultimate burden calculations on the 
expected overall number of refractive exams that would result in a 
written prescription every year rather than trying to determine a 
number for a typical practice. See Paperwork Reduction Act, section 
VIII, infra, for an updated estimate for the amended Rule.
    \275\ WS Transcript at 40.
    \276\ NPRM Comment #0024 submitted by Neville.
    \277\ Id.
    \278\ Some of these comments were discussed above with respect 
to the Commission's determination that the failure to provide a 
prescription continues to be an unfair act or practice. See section 
II.A supra. One other commenter expressed disfavor with the 
proposal, but did not provide specific reasons for the opposition. 
Anonymous (NPRM Comment #0004).
    \279\ AOA (WS Comment #0047 submitted by Benner).
    \280\ AOA (WS Comment #0047 submitted by Benner). Appendix A to 
this comment contains a summary it created of the purported study 
results.
    \281\ AOA (WS Comment #0047 submitted by Benner). Similarly, at 
the workshop, Dr. Stivers suggested that most consumers sign papers 
at the doctor's office without reading them and questioned whether 
the confirmation of prescription release ``accomplish[es] anything 
in the broader context of all of the information that the patient is 
trying to absorb in that kind of environment.'' WS Transcript at 10.
    \282\ See also Stivers, WS Transcript at 11 (noting that 
regulations like the Eyeglass Rule require businesses to hire 
expensive attorneys and consultants to advise them, and the 
Commission should take into account the burden placed on ``the vast 
majority of practitioners or businesses in general that are 
absolutely law abiding.''
    \283\ See section VIII, infra.
    \284\ During the pendency of the Eyeglass Rulemaking, the 
American Optometric Association filed a comment in response to the 
Commission's Paperwork Reduction Act (``PRA'') notice for the 
Contact Lens Rule. That comment, CLR PRA Comment #0007 (submitted by 
Benner), is available at: https://www.regulations.gov/comment/FTC-2023-0049-0007 (emphasis in original).
    \285\ AOA (NPRM Comment #0023 submitted by Benner; WS Comment 
#0047 submitted by Benner).
    \286\ Rosemore (WS Comment #0045) ``As an optometrist, the added 
requirements would be a significant burden on my practice . . . I'm 
not sure what sort of issue the Commission believes it is solving 
here.'' Dr. Rosemore added, ``I am disturbed that my profession 
continues to get treated like a punching bag. It appears to me that 
we are viewed by some at the Commission as predators to consumers 
instead of the doctors we are to our patients. I did nothing to 
deserve that treatment.'' Coast Eyes Pllc (WS Comment #0046) 
(``Nothing is broken here. Patients get their prescriptions without 
conflict. The financial/time/paper (material) burden on small 
business is not justified by the number of complaints.)''.
    \287\ Anonymous (NPRM Comment #0006) (``something that would 
take an immense amount of time and take away from patient care.''); 
Anonymous (NPRM Comment #0007) (isn't ``necessary'' and would be 
``very time consuming.''); Cooper (NPRM Comment #0009) (``yet 
another example of an unnecessary, time consuming, and intrusive 
requirement [that would] add to cost of doing business which 
ultimately gets passed on to the patient (consumer)''); Anonymous 
(NPRM Comment #0011) (costly, time consuming, and redundant). WS 
Transcript at 23-24.
    \288\ Durkee (NPRM Comment #15).
    \289\ WS Transcript at 9. Voicing a similar concern, Dr. 
Montaquila said he's seen widespread confusion from patients as to 
why they are signing a prescription or confirmation of prescription 
release and he states that ``they don't understand the process.'' WS 
Transcript at 24. Dr. Masoudi raised communication issues 
surrounding the form when language barriers exist between the 
patient and staff. WS Transcript at 27.
    \290\ WS Transcript at 23.
    \291\ WS Transcript at 23-24.
    \292\ WS Transcript at 29.
    \293\ WS Transcript at 29.
    \294\ AAO (NPRM Comment #27).
    \295\ Id. The AAO recommended the Commission exempt from the 
confirmation-of-prescription-release amendment ophthalmology 
practices with fewer than ten full-time employees because they often 
operate with limited administrative support and may not use 
electronic health records. Id.
    \296\ WS Transcript at 31. Dr. Montaquila stated that he has not 
seen much difference since the Contact Lens Rule confirmation 
requirement was put in place andthat he'll give prescriptions 
whether or not there is a confirmation requirement in place.
    \297\ WS Transcript at 29.
    \298\ WS Transcript at 37-38.
    \299\ NPRM, 88 FR 287.
    \300\ NPRM, 88 FR 287.
    \301\ Id. at 281.
    \302\ The Commission has determined not to add an exemption for 
ophthalmology practices with fewer than ten full-time employees, as 
requested by the AAO. See supra note 295. It is equally important 
for patients at these practices to be aware of their right to 
receive their prescriptions and receive their prescriptions as it is 
for patients at larger practices. If the practices sell eyeglasses 
or have a direct or indirect financial interest in the sale of 
eyeglasses, they must comply with the confirmation-of-prescription-
release amendments.
    \303\ WS Transcript at 34.
    \304\ WS Transcript at 34.
    \305\ Warby Parker (ANPR Comment #0817 submitted by Kumar) (bill 
of rights and signage); Tedesco (ANPR Comment #0042) (signage).
    \306\ AOA (NPRM Comment #0023 submitted by Benner); Masoudi (WS 
Transcript at 38) (suggesting that the FTC should be more active in 
making consumers more aware of their rights ``before they even walk 
in our door.''). Other commenters discussed a need for greater 
education generally in this area. See section VII.B, infra.
    \307\ NPRM Comment #0023 submitted by Benner. According to the 
AOA, these include: (1) online retailers cannot guarantee the 
glasses purchased will meet the consumers' visual needs; (2) if the 
eyeglasses do not fit well, the online retailer is not required to 
adjust the glasses in person, but will often instruct the consumer 
how to self-

[[Page 60785]]

adjust the glasses; and (3) the online retailer is not obligated to 
respond to any complaints or issues surrounding the purchase. Id. 
See also American Optometric Association, ``AOA: No letting up on 
Eyeglass Rule advocacy,'' Nov. 2, 2023, https://www.aoa.org/news/advocacy/federal-advocacy/aoa-no-letting-up-on-eyeglass-rule-advocacy.
    \308\ Durkee (NPRM Comment #15). At the workshop, panelist Pete 
Sepp of NTU inquired about the FTC not enforcing the Rule against 
prescribers who take actions aimed at improving automatic 
prescription release and suggested such actions be treated as ``safe 
harbors'' from FTC enforcement. One example he provided was for 
prescribers to show a training video to their employees on 
prescription release and retain evidence of the training. WS 
Transcript at 33. As explained in response, although every instance 
where a prescription is not automatically provided to a patient is a 
civil penalty violation, the Commission is generally not looking for 
one-off instances of non-compliance in its enforcement actions. See 
Bernstein (WS Transcript at 34). Nevertheless, the Commission does 
not believe expressly establishing ``safe harbors'' of the type 
described by Pete Sepp would sufficiently counter the significant 
non-compliance detailed elsewhere in this document.
    \309\ See section II, supra.
    \310\ Id.
    \311\ NPRM, 88 FR 263. This inquiry is particularly relevant in 
that, as the Commission has stated, it is primarily interested in 
bringing actions against repeat offenders, not prescribers who may 
make a one-off mistake in forgetting to release a prescription.
    \312\ U.S. v. Doctors Eyecare Ctr., Inc., No. 3:96-cv-01224-D 
(N.D. Tex. June 24, 1996). The complaint alleged that the eye care 
center only released prescriptions when patients asked for them, and 
included waivers of liability on patients when doing so. The 
prescriber paid a $10,000 civil penalty and was enjoined from future 
violations of the Eyeglass Rule. See Press Release, Fed. Trade 
Comm'n, Dallas Eyecare Center Agrees to Settle Charges That They 
Failed to Give Consumers Copies of Their Eyeglass Prescriptions (May 
3, 1996), https://www.ftc.gov/news-events/press-releases/1996/05/dallas-eyecare-center-agrees-settle-charges-they-failed-give.
    \313\ NAROC's comment mentions that, while a requirement for 
signage in the office was rejected as inadequate, industry members 
might use the option of making information easily available to 
customers in other formats, such as websites or point of sale 
handouts about patients' rights or prescriber responsibilities. NPRM 
Comment #0024 submitted by Neville. NAROC proffered these ideas as 
additive to, and not instead of, the confirmation proposal, which it 
supports. An anonymous commenter suggests that the FTC should 
educate the consumer and ``[m]aybe provide a template to the 
providers so that the consumer gets the same info, presented the 
same way at every provider?'' WS Comment #0037. It is unclear 
whether the commenter is suggesting this action in addition to, or 
instead of, the signed acknowledgment proposal. The Commission 
discusses business and consumer education as an additional method to 
increase business and consumer awareness of responsibilities and 
rights, respectively, in section VII.B, infra.
    \314\ NPRM, 88 FR 264 (signage), 263-64 (bill of rights).
    \315\ See CLR SNPRM, 84 FR 24675; Eyeglass I Rule, 43 FR 23998.
    \316\ NPRM, 88 FR 263.
    \317\ Commission staff first identified this issue in its 
Eyeglass II Report, where it explained that the automatic release 
requirement had not helped to prevent ``evidentiary squabbles''--as 
the Commission had hoped it would--but instead had increased them, 
because whether or not a prescriber had released a prescription 
could not, in most cases, be ascertained absent documentary 
evidence. Eyeglass II Report, supra note 14, at 275-76.
    \318\ See sections IV.C.2.a and VIII.A, infra (describing how 
many prescribers are using confirmation forms that contain 
extraneous information and thus, likely take far longer to read and 
sign than actually required under the rule).
    \319\ This calculation is based on estimates that there are 165 
million eyeglass wearers who get exams every other year, and that 
there are 18,000 ophthalmologists and 43,000 optometrists in the 
United States. As discussed above, section I.D.5, supra note 67, 
this may undercount the number of optometrists, which could mean the 
per-provider burden is even less. On the other hand, the burden may 
fall differently on different providers (depending on their size, or 
volume, or electronic-records adoption, for instance), and at least 
one commenter, the National Taxpayers Union, felt it might be 
disproportionally felt by small providers. See section IV.B, supra.
    \320\ AOA (WS Comment #0047 submitted by Benner).
    \321\ Id.
    \322\ AOA's appendix A to its workshop comment (WS Comment #0047 
submitted by Benner) does not contain information about the 
methodology of the survey or the representativeness of the surveyed 
population. This analysis assumes the methodology is sound and the 
population surveyed is appropriately representative--assumptions 
which may or may not be correct.
    \323\ Moreover, 28% of respondents disagree with the statement 
that the amount of paperwork they have to complete at a doctor's 
appointment is overwhelming (with another 25% responding neutrally) 
and 34% of respondents disagree with the statement that the 
complexity of the paperwork they have to complete at a doctor's 
appointment is overwhelming (with another 25% responding neutrally).
    \324\ However, the Commission notes that some of the burden that 
commenters suggest has resulted from the CLR confirmation-of-
prescription-release requirement appears to be wrongfully attributed 
to that requirement. See sections IV.C.2.a, infra, and section 
VIII.A, infra (describing how in one form in use by many 
prescribers' offices, and recommended in the AOA's online toolkit 
for complying with the CLR, five out of six paragraphs are 
extraneous to the confirmation-of-prescription-release proposal).
    \325\ These options include permitting electronic delivery of 
eyeglass prescriptions, in which case prescribers would not need to 
request that the patient acknowledge receipt of the prescription. 
Yet, flexibility exists for prescribers who prefer to provide paper 
copies to their patients, as they do not need to offer an electronic 
option. See section III.C, supra. For instances in which a patient 
refuses to confirm prescription release, the prescriber shall note 
the patient's refusal on the document and sign it.
    \326\ See section III.C, supra.
    \327\ If multiple eyeglass prescriptions are provided on paper 
at the same time, the prescriber can obtain confirmation of 
prescription release with one signature, and need not obtain 
separate signatures for each prescription confirmation.
    \328\ To reduce the burden associated with prescription release, 
a prescriber could create a document requesting a single signature 
to confirm receipt of both an eyeglass and a contact lens 
prescription (in cases where both prescriptions are finalized at the 
same time). Such a document could meet the requirements of both 
rules so long as it is clear and conspicuous what the patient is 
signing for, and that the signature requested confirms receipt of 
both the contact lens and eyeglass prescriptions. Similarly, as 
mentioned above, a prescriber could use one document to obtain 
verifiable affirmative consent to digital prescription release of 
both contact lens and eyeglass prescriptions.
    \329\ NPRM, 88 FR 287.
    \330\ Id.
    \331\ 16 CFR 315.3(c)(3).
    \332\ See NPRM, 88 FR 260-61. The same purpose is stated for the 
exemption in the Contact Lens Rule. CLR Final Rule, 85 FR 50687.
    \333\ Current guidance issued by the Commission in connection 
with the Contact Lens Rule states the same. FTC, FAQs: Complying 
with the Contact Lens Rule, https://www.ftc.gov/business-guidance/resources/faqs-complying-contact-lens-rule (``If you're not sure if 
your interest qualifies, err on the side of caution and ask your 
patients to confirm receipt of their prescriptions.'').
    \334\ One commenter requested an exemption in long-term care 
settings for the confirmation requirement, as well as for 
affirmative consent for digital delivery. This commenter said that, 
in the long-term care setting, the parties responsible for the 
patients are almost never present during the exam and the patients 
themselves are not able to give consent and as a result, prescribers 
coordinate care with, and provide prescriptions to, facility staff. 
Morer (NPRM Comment #0021). In such situations, the Commission 
recommends the prescriber note in their records to whom the 
prescription was provided (e.g., staff or caregiver), and whether it 
was provided on paper, or made available digitally and by what 
method. As with the instance where a patient refuses a copy of a 
prescription, see supra note 325,

[[Page 60786]]

the prescriber could relay that information to the Commission should 
questions about compliance arise.
    \335\ 16 CFR 315.3(c)(1) (CLR); NPRM, 88 FR 266.
    \336\ Montaquila (WS Transcript at 22). The Commission notes 
that other offices using EHRs could collect and store signatures 
electronically, as Dr. Montaquila noted they do for the consent to 
digital delivery. Id. at 23.
    \337\ Montaquila presentation, FTC Eyeglass Rule Workshop, 
https://www.ftc.gov/system/files/ftc_gov/pdf/Stephen-Montaquila-OD-Presentation.pdf.
    \338\ AOA, Contact Lens Rule Compliance Toolkit (July 2020), 
https://www.aoa.org/AOA/Documents/doctor%20resources/Contact-Lens-Rule-Compliance-Toolkit.pdf.
    \339\ WS Transcript at 22. Dr. Montaquila shared an example of a 
what the prescription pad looks like. See Montaquila presentation, 
FTC Eyeglass Rule Workshop, https://www.ftc.gov/system/files/ftc_gov/pdf/Stephen-Montaquila-OD-Presentation.pdf. This pad is also 
shown in the AOA's toolkit, with a note that doctors should contact 
the AOA Marketplace if interested in obtaining the product. See AOA, 
Contact Lens Rule Compliance Toolkit at 9 (July 2020), https://www.aoa.org/AOA/Documents/doctor%20resources/Contact-Lens-Rule-Compliance-Toolkit.pdf. At the bottom of each prescription sheet, 
after a statement in bright blue declaring, ``Contact lenses are 
medical devices which require ongoing medical care for optimal 
performance and safety. Please contact our office if you experience 
any signs of complications including pain, redness, loss of 
vision,'' there is a statement in black for patients to ``Sign below 
to indicate you were provided a copy of your contact lens 
prescription at the completion of your contact lens fitting,'' with 
a space for a signature and the date.
    \340\ WS Transcript at 22. Dr. Montaquila referenced 
HealthIT.gov data, as of 2021. See U.S. Dep't of Health & Human 
Servs., ONC, ``Office-based Physician Electronic Health Record 
Adoption,'' https://www.healthit.gov/data/quickstats/office-based-physician-electronic-health-record-adoption. The 88% figure, 
however, pertains to U.S. office-based physicians, but not 
specifically to optometrists or ophthalmologists. Moreover, this 
figure relates to adoption of EHR by doctors for their 
recordkeeping, but does not necessarily cover the use of EHR, and 
specifically portal-use, by patients themselves. There may be 
instances where doctors retain their records in electronic format 
but do not make them available via portal for their patients to 
access. And even when records are available electronically, many 
patients may opt not to use prescriber portals. See section III.B.1, 
supra (discussing patient portal access and usage) and section 
VIII.B.2, infra (discussing AOA survey of a small sample of 
optometrists showing that just 35% provided prescriptions 
electronically).
    \341\ WS Transcript at 22.
    \342\ WS Transcript at 22. Dr. Montaquila did not produce this 
study to staff. A news article on the study is available at: Cornell 
Chronicle, ``Study: E-prescribing cuts medication errors by seven-
fold'' (2010), https://news.cornell.edu/stories/2010/03/e-prescribing-cuts-medication-errors-seven-fold.
    \343\ WS Transcript at 22.
    \344\ AOA (CLR PRA Comment #0007 submitted by Benner), https://www.regulations.gov/comment/FTC-2023-0049-0007 (filed in response to 
FTC Request For Comment, 88 FR 55044 (Aug. 14, 2023), https://www.regulations.gov/document/FTC-2023-0049-0001). As discussed more 
fully in the PRA section of this document (section VIII, infra notes 
452-55 and accompanying text.), the Commission has doubts about the 
methodology used for this survey,and does not rely on it for any 
determinations.
    \345\ WS Transcript at 22-23. Dr. Montaquila stated that EHR or 
practice management systems were not flexible enough to accommodate 
this functionality. Id.
    \346\ The Commission points out that if the prescriber delivers 
the prescription digitally, but the patient has not opted-in to the 
digital delivery option, the prescriber has not satisfied the 
requirements of Sec.  456.2. See section III.B.1, supra.
    \347\ See Section VIII, infra.
    \348\ Section 456.4(a)(1)(ii) relating to digital prescription 
release, now cross references Sec.  456.3, requiring verifiable 
affirmative consent to providing the prescription in digital format.
    \349\ See section III.B, supra.
    \350\ WS Transcript at 36.
    \351\ NPRM, 88 FR 265. See section III.C.3, supra notes 239-40 
and text (citing Commission language from the CLR NPRM and CLR SNPRM 
supporting the position that, for the CLR, prescribers may obtain a 
patient's signature either on paper or digitally.).
    \352\ Although prescribers may similarly comply with the CLR by 
obtaining digital signatures, the Commission recognizes that, for 
the time being, the text of the CLR will differ from that of the 
Eyeglass Rule by not expressly permitting signature collection in a 
digital format. The Commission can amend the CLR to include this 
express permission during its next rule review and, in the meantime, 
can provide clarity to prescribers through guidance materials.
    \353\ 16 CFR 456.2(a).
    \354\ 16 CFR 315.4.
    \355\ 15 U.S.C. 7602.
    \356\ NPRM, 88 FR 271.
    \357\ Id. at 286.
    \358\ Id. at 281.
    \359\ NAROC (NPRM Comment #0024 submitted by Neville); NAROC (WS 
Comment #0049 submitted by Neville). NAROC noted, however, that it 
was not aware of significant instances in which prescribers had 
refused to automatically provide prescriptions until receiving 
payment from the insurance company. NAROC (NPRM Comment #0024 
submitted by Neville); Lovejoy (WS Transcript at 48).
    \360\ NPRM Comment #0025 submitted by Montclair.
    \361\ NPRM Comment #0027 submitted by Repka.
    \362\ Id.
    \363\ WS Comment #0039. See also Hyder (WS Transcript at 47) 
(recommending that the FTC clarify the difference between covered 
services--such as eye health exams--and non-covered services--such 
as refractive exams--because ``insurance is complex and I think 
sometimes it can be a challenge to confirm whether or not the 
coverage is available for a patient.'').
    \364\ See section II.C, supra.
    \365\ Beatty (WS Transcript at 52); Lovejoy (WS Transcript at 
52-53).
    \366\ Botha (WS Transcript at 53).
    \367\ However, prescribers who wait to collect payment for the 
examination until the eyeglass purchase is completed are precluded 
from using a confirmation method in which the statement confirming 
receipt of the prescription is included on the sales receipt.
    \368\ 16 CFR 456.1(b).
    \369\ 16 CFR 456.2(a).
    \370\ See AOA (ANPR Comment #0849 submitted by Peele); Brauer 
(ANPR Comment #0045); Yadon (ANPR Comment #0046); Bolenbaker (ANPR 
Comment #0633). Some of these commenters also stated that the 
defined term in the Rule is at odds with the definition of eye 
examination in the American Medical Association's Current Procedural 
Terminology codes to bill outpatient and office procedures, because 
that definition does not include a refraction. AOA (ANPR Comment 
#0849 submitted by Peele); Bolenbaker (ANPR Comment #0633).
    \371\ AOA (ANPR Comment #0849 submitted by Peele); Lunsford 
(ANPR Comment #0346); Bolenbaker (ANPR Comment #0633).
    \372\ Bolenbaker (ANPR Comment #0633).
    \373\ Lehman (ANPR Comment #0610).
    \374\ NPRM, 88 FR 279.
    \375\ NPRM, 88 FR 281.
    \376\ NPRM Comment #0025 submitted by Montclair.
    \377\ NPRM Comment #0028 submitted by Sepp.
    \378\ NPRM Comment #0024 submitted by Neville.
    \379\ Id.
    \380\ AAO (WS Comment #0027).
    \381\ Id.
    \382\ AOA (WS Comment #0047).
    \383\ NPRM Comment #0023 submitted by Benner (``The refractive 
error measured should be analyzed with other testing data, and an 
assessment of the patient's visual needs obtained during an in-
person examination. This information is used to determine if, and in 
what amount, an optical correction is needed to provide optimal 
vision and comfort for all viewing distances.''); see also OAA (NPRM 
Comment #0020 submitted by Allen) (``A refraction may include 
objective and subjective assessment of the patient's refractive 
status; however, the results of a refraction do not provide all the 
information needed to determine an optical prescription.''); AOA (WS 
Comment #0047 submitted by Benner) (``we believe that the market has 
significantly evolved . . . thereby negating the need for any 
language adjustments in the rule. We believe the original language 
should stand without revision.'').
    \384\ AOA (WS Comment #0047 submitted by Benner).
    \385\ Beatty (WS Transcript at 54).
    \386\ Id. at 55-56.
    \387\ Boatner (WS Comment #0036); see also Lovejoy (WS 
Transcript at 49) (describing a

[[Page 60787]]

scenario where an ophthalmologist may ``want to do a measure of 
whether or not there is a refractive error to help with the medical 
diagnosis, but may not want to write a prescription at the end of 
that because that's not what the chief complaint is about and they 
don't see a need for the patient to have a prescription for 
corrective eyewear.'').
    \388\ Boatner (WS Comment #0036); Beatty (WS Transcript at 49).
    \389\ Boatner (WS Comment #0036); Lovejoy (WS Transcript at 51, 
56) (stating that an exemption for use of medical judgment to 
withhold the prescription should be written into the Rule).
    \390\ Boatner (WS Comment #0036); see also Hyder (WS Transcript 
at 50).
    \391\ 16 CFR 456.2(c).
    \392\ See Hyder (WS Transcript at 50) (noting that some 
ophthalmologists have reported having patients say, ``you're not 
allowed to charge me for my refraction,'' and opining, ``there needs 
to be something that states in the rule that refraction services are 
different than the cost of a prescription.'').
    \393\ Botha (WS Transcript at 49).
    \394\ The term has been revised in the following sections of the 
final rule: (1) Definitions, Section 456.1(a), (b), (d), (e) and 
(g); (2) Separation of examination and dispensing, Sec.  456.2(a)(1) 
and (2) and (b) through (d); and (3) Confirmation of prescription 
release, Sec.  456.4(a)(1).
    \395\ The Commission also makes clear that requirement to 
release prescriptions does not depend on how prescribers label their 
exams, and whether a prescriber charges a fee for that particular 
practice. The definition for the amended refractive eye exam 
terminology remains ``the process of determining the refractive 
condition of a person's eyes or the presence of any visual anomaly 
by the use of objective or subjective tests.'' Sec.  456.1(b). A 
prescriber who charged a patient only one fee--designated as for an 
eye health exam--but also performed an exam that determined the 
refractive condition of a person's eyes or the presence of any 
visual anomaly, is still required to automatically release the 
prescription upon completion of the exam. A prescriber is only 
permitted to not release a prescription automatically following a 
refractive exam if the prescriber makes a medical determination that 
the patient should not be given a prescription for eyeglasses.
    \396\ Workshop panelists who spoke on this issue were unanimous 
in agreeing that if a prescriber decides not to provide the 
prescription in their medical judgment, then it is appropriate that 
they do not sell eyewear to that patient. WS Transcript at 57.
    \397\ See, e.g., ACLens, ``Measuring Pupillary Distance (PD),'' 
https://www.aclens.com/measuring-pupillary-distance.
    \398\ The Rule, as amended, defines a prescription as the 
``written specifications for lenses for eyeglasses which are derived 
from a refractive eye examination, including all of the information 
specified by state law, if any, necessary to obtain lenses for 
eyeglasses.'' 16 CFR 456.1(g). As of the date of the NPRM, only four 
States, Alaska, Kansas, Massachusetts, and New Mexico, required the 
inclusion of pupillary distance measurements on prescriptions. NPRM, 
88 FR 273.
    \399\ NPRM, 88 FR 276-77.
    \400\ NPRM, 88 FR 276-77.
    \401\ NPRM, 88 FR 277.
    \402\ OAA (NPRM Comment #0020 submitted by Allen); AOA (NPRM 
Comment #0023 submitted by Benner).
    \403\ AOA (NPRM Comment #0023 submitted by Benner); see NPRM, 88 
FR 276.
    \404\ NAROC (Comment #0024).
    \405\ OAA (NPRM Comment #0020 submitted by Allen).
    \406\ AAO (NPRM Comment #0027 submitted by Repka).
    \407\ AAO (NPRM Comment #0027 submitted by Repka). Others also 
expressed favor with the Commission's decision not to require 
pupillary distance on prescriptions. Anonymous (NPRM Comment #0012) 
(the only way to ensure accurate measurement is by having the 
patient try on the desired frame and it is impossible to determine 
segment height and optical center without fitting the frame on the 
patient's face and marking the lens center); Anonymous (WS Comment 
#0034) (requiring pupillary distance on prescriptions would be the 
``absolute death of the optical industry'' and it would be unfair to 
``require people who properly train their staff to freely give the 
expertise so the consumer can go to another provider that has no 
such staff and get glasses.'').
    \408\ Eyeglasses.com (WS Comment #0040).
    \409\ Id. Eyeglasses.com also stated that, for purchases of 
bifocal, trifocal, or progressive lenses, a segment height is 
required and that consumers should be able to get a segment height 
measurement from an optical professional so they can include it when 
ordering eyeglasses online. Id.
    \410\ 1-800 CONTACTS (NPRM Comment #0025 submitted by 
Montclair).
    \411\ Id.
    \412\ Id.
    \413\ This commenter urged the Commission to require prescribers 
to ask patients to confirm receipt of the PD measurement, in 
addition to receipt of the prescription. 1-800 CONTACTS (NPRM 
Comment #0025 submitted by Montclair).
    \414\ Id.
    \415\ Beckman (WS Comment #0041).
    \416\ Id. An unidentified commenter agreed, indicating that when 
the optometrist fails to measure and include pupillary distance 
measurements on the prescription, they are preventing the consumer 
from shopping around and discovering lower prices elsewhere. 
Anonymous (NPRM Comment #0010). Another consumer comment does not 
explicitly mention pupillary distance, but stated it is their right 
to receive all of their personal medical information, and states 
they have to go to other sellers to be able to afford eyeglasses. 
Crete (WS Comment #0035).
    \417\ See section I.C, supra.
    \418\ See NPRM, 88 FR 274.
    \419\ As explained in the NPRM, pupillary distance measuring 
systems vary in cost and precision, and ``if the Commission required 
prescribers to include pupillary distance measurements on 
prescriptions, it is unlikely that prescribers would use less 
expensive rulers and the like, but instead--for professional and 
liability reasons--would select more technologically sophisticated 
methods, such as a digital centration device, to take the 
measurement. Such devices, and the training, staff, and exam time 
necessary to operate the devices, could be costly.'' 88 FR 276.
    \420\ The Commission recognizes that there is a tension between 
the fact that there are zero and low-cost methods to measure 
pupillary distance and the fact that prescribers claim providing the 
measurement requires expensive equipment and potential increases in 
staff. However, both things can be true. Consumers are able to 
ascertain serviceable pupillary distance measurements without 
expensive training and equipment, while medical professionals will 
likely want--and perhaps even feel professionally obligated--to 
provide a measurement that meets higher standards of technical 
precision.
    \421\ EyeBuyDirect, ``How to Measure Pupillary Distance (PD),'' 
https://www.eyebuydirect.com/guides/how-to-measure-your-pd.
    \422\ Zenni, ``Measure your pupillary distance (PD),'' https://www.zennioptical.com/measuring-pd-infographic. The Commission has 
not analyzed whether the various methods consumers may use to 
determine their pupillary distance, or whether sellers manufacturing 
eyeglasses in accordance with self-measured pupillary distances, are 
permitted in all jurisdictions. The Commission noted this in the 
NPRM, 88 FR 274, but did not receive any comments on this topic in 
response to the NPRM.
    \423\ The FTC has heard from consumers that they have been 
charged between $15 and $40 to obtain an in-person pupillary 
distance measurement.
    \424\ Bailer (ANPR Comment #0191); Emanuel (ANPR Comment #0282); 
Land (ANPR Comment #0311).
    \425\ ANPR Comment #0748 submitted by Cutler.
    \426\ NPRM, 88 FR 276.
    \427\ Because the Commission did not find adequate evidence of 
unfairness, it need not consider alternative ways to remedy that 
unfairness. Thus, it does not address seller 1-800 CONTACTS' 
alternate methods for providing pupillary distance to patients.
    \428\ WS Transcript at 38.
    \429\ WS Transcript at 4-6, 16.
    \430\ WS Transcript at 23-24.
    \431\ Anonymous (WS Comment #0037).
    \432\ NPRM Comment #0027 submitted by Repka.
    \433\ NPRM Comment #0024 submitted by Neville. In addition, at 
the workshop, Mr. Lovejoy stated that the FTC should give 
prescribers some guidance on how to educate their own customers and 
make sure the message is consistent throughout the industry. WS 
Transcript at 58.
    \434\ See, e.g., https://www.ftc.gov/business-guidance/resources/complying-eyeglass-rule (for prescribers); https://consumer.ftc.gov/articles/buying-prescription-glasses-or-contact-lenses-your-rights (for consumers); https://www.ftc.gov/news-events/news/press-releases/2020/12/ftc-sends-28-warning-letters-regarding-agencys-eyeglass-rule (press release); https://consumer.ftc.gov/consumer-alerts/2020/12/ftc-warns-eye-care-prescribers-follow-law-or-else (consumer

[[Page 60788]]

alert); https://www.ftc.gov/business-guidance/blog/2023/04/required-action-after-refraction-ftc-staff-sends-cease-desist-letters-about-eyeglass-rule-compliance (business guidance).
    \435\ 5 CFR 1320.8(b)(3)(vi).
    \436\ 16 CFR 456.4(a)(1).
    \437\ NPRM, 88 FR 283.
    \438\ Id. at 282-83.
    \439\ CLR Final Rule, 85 FR 50709. The estimates for the Contact 
Lens Rule's confirmation requirement were, in turn, based on a (1) 
survey of how long it took consumers to read a proposed Contact Lens 
Rule confirmation statement, and (2) previously approved burden 
estimates for a similar patient-acknowledgment requirement under 
HIPAA rules, found at 45 CFR 164.520(c)(2)(ii).
    \440\ 88 FR 284.
    \441\ Anonymous (NPRM Comment #0006).
    \442\ Anonymous (NPRM Comment #0007).
    \443\ AOA (NPRM Comment #0023). See also Rep. Williams, House 
Committee on Small Business (WS Comment #0044) (``The Committee 
fears that this rule will have a disproportionate impact on small 
businesses by adding redundant requirements to already understaffed 
practices.'').
    \444\ Michaels (WS Transcript at 9) (``I don't think that it's a 
burden to provide the prescription. Where I see the burden is to ask 
for paperwork, to say, `Sign this piece of paper acknowledging that 
we've already given you a prescription.' There's a lot of time, 
effort, discussion around that. I think that that is something that 
is greatly underestimated in terms of how long it takes.''); AOA (WS 
Comment #0047 submitted by Benner).
    \445\ Coast Eyes Pllc (WS Comment #46).
    \446\ Montaquila (WS Transcript at 23-24). Dr. Montaquila did 
not break down his 4-minute estimate by task, so it is unclear how 
long he estimates it takes for a consumer to simply read and sign 
the confirmation statement, as opposed to the time it takes for his 
staff to print out the prescription and confirmation and store the 
patient confirmation as a record. In its NPRM, the Commission 
allowed a total of two minutes and 10 seconds for the entire process 
(one minute for prescribers to print out the prescription, 10 
seconds for the confirmation signature, and an additional minute for 
staff to store the signed confirmation.).
    \447\ National Taxpayers Union (NPRM Comment #0028 submitted by 
Sepp).
    \448\ See section IV.B, supra note 274 and text. As noted 
previously, the Commission has not been able to replicate the NTU 
estimate. Accepting NTU's assumption that a small practice performs 
3000 refractive eyeglass examinations per year, the confirmation 
requirement would add a paperwork burden of $1,439.88 for such a 
practice based on the proposal and PRA analysis applied in the NPRM, 
and an increased paperwork burden of $1,318.73 based on the 
amendment and PRA analysis of this Final Rule. While the AOA has 
stated that approximately 92% of optometry practices have fewer than 
25 employees and average $826,612 in gross receipts per annum (AOA 
NPRM Comment #23), the Commission does not have information 
detailing how many refractive eyeglass examinations a typical 
practice performs--or even what a ``typical practice'' is and 
whether it is advisable to weigh the burden based on a typical 
practice experience--and finds it preferable to calculate the burden 
based on the overall number of eyeglass wearers in the United 
States, and the estimate that each wearer obtains a refractive eye 
exam for eyeglasses every two years.
    \449\ NAROC (NPRM Comment #0024 submitted by Neville); see also 
Consumer Action (NPRM Comment #0026 submitted by McEldowney) (``we 
do not believe it is a burden on providers to obtain, document, and 
retain a consumer's affirmative receipt of their prescription.'').
    \450\ Neville (WS Transcript at 28-29).
    \451\ Coast Eyes Pllc did not provide any evidence in support of 
its $18,000 estimate, and it is not clear where this calculation 
comes from.
    \452\ AOA (CLR PRA Comment #0007 submitted by Benner), https://www.regulations.gov/comment/FTC-2023-0049-0007 (filed in response to 
FTC Request For Comment, 88 FR 55044 (Aug. 14, 2023), https://www.regulations.gov/document/FTC-2023-0049-0001).
    \453\ Id. According to the AOA, the survey was conducted in-
house by its Health Policy Institute and Research Departments, and 
distributed to member optometrists via AOA's weekly email newsletter 
with a link and invite to the survey titled, ``Voice your concerns 
by Oct. 9: Complying with the FTC Contact Lens Rule.'' Of members 
who responded to the AOA's link request, 327 completed the survey.
    \454\ FTC Notice, Proposed Collection, 88 FR 88076, 88079, Dec. 
20, 2023 (``2023 CLR PRA''). Following this notice and response to 
commenters, on Jan. 26. 2024, OMB approved the extension request for 
CLR clearance. Notice of Office and Management and Budget Action, 
OMB Control No. 3084-0127.
    \455\ The Commission notes that while the AOA claims to 
represent some 50,000 optometric professionals, only 327 members 
responded to the AOA's invitation and completed the survey, which 
could indicate that many of those who self-selected and took part in 
the survey were those who have concerns about the confirmation 
requirement, while most other AOA members do not have such concerns. 
However, there could be other reasons for the relatively small 
number of prescribers (in proportion to the total membership) who 
responded, so the Commission will not draw inferences from the low 
response rate.
    \456\ 2023 CLR PRA, 88 FR 88079.
    \457\ See section IV.C.2.a, supra, discussing the AOA model form 
exhibited by Dr. Montaquila at the workshop. A copy of the model 
form is available at https://www.aoa.org/AOA/Documents/doctor%20resources/Contact-Lens-Rule-Compliance-Toolkit.pdf.
    \458\ Id.
    \459\ Id.
    \460\ Montaquila (WS Transcript at 23).
    \461\ The Commission has never subscribed to the belief that 
consumers will be greatly confused as to why they are signing a 
straightforward confirmation statement such as, ``My eye care 
professional provided me with a copy of my contact lens prescription 
at the completion of my contact lens fitting.'' The Commission's 
understanding is based on a common sense reading of the statement, 
but is also supported by a survey submitted during the Contact Lens 
Rule rulemaking showing that 90% of consumers responded they 
understood the proposed confirmation statement, and 94% responded 
that they had no follow-up questions. Laurence C. Baker, ``Analysis 
of Costs and Benefits of the FTC Proposed Patient Acknowledgment and 
Recordkeeping Amendment to the Contact Lens Rule,'' 13 (2017), 
https://www.ftc.gov/system/files/summaries/initiatives/677/10192017_meeting_summary_from_mko_for_the_contact_lens_rule_rulemaking_proceeding.pdf.
    \462\ The Commission recently made a similar revision to its 
estimate of the time required to obtain confirmation for the Contact 
Lens Rule, and the revised burden figures received clearance by the 
Office of Management and Budget. See supra note 454.
    \463\ Standards for Privacy of Individually Identifiable Health 
Information, Final Rule, 67 FR 53182, 53261 (Aug. 14, 2002) 
(implementing 45 CFR 164.520(c)(2)(ii)).
    \464\ See section I.D.5, supra note 73.
    \465\ The Commission relies on industry sources for its estimate 
that eyeglass wearers typically obtain one refractive eye exam every 
two years. See, e.g., AOA, Excel and Jobson Medical Information, The 
State of the Optometric Profession: 2013, at 4, https://www.reviewob.com/wp-content/uploads/2016/11/8-21-13stateofoptometryreport.pdf (showing an average interval between 
exams of 25 months); AOA, Comprehensive Eye Exams, https://www.aoa.org/healthy-eyes/caring-for-your-eyes/eye-exams? (showing 
recommended examination frequency for adult patients 18-64 of ``at 
least every two years'' for asymptomatic/low risk patients). In 
contrast to the CLR, which establishes a one-year minimum term for 
most contact lens prescriptions (16 CFR 315.6(a)) (a term-length 
mirrored by a majority of States, see CLR NPRM, 81 FR 88545, n.245) 
the Eyeglass Rule does not discuss or define prescription expiration 
terms, and many States do not set any limit for eyeglass 
prescriptions. Some eyeglass wearers, therefore, can legally go many 
years between refractive eye examinations. But the Commission will 
use two years as a basis for purposes of this assessment, since that 
is recommended interval for the majority of eyeglass wearers.
    \466\ See, e.g., CLR SNPRM, 84 FR 24693 n.347.
    \467\ CLR Final Rule, 85 FR 50709. This estimate was based on 
responses to a consumer survey regarding how long it would take 
consumers to read the form, and a prior PRA estimate for consumers 
to complete a similar signed acknowledgment. See CLR SNPRM, 84 FR 
24693; NPRM, 88 FR 282.
    \468\ See supra note 462-63 and accompanying text.
    \469\ In order to utilize Sec.  456.4(a)(1)(ii) however, a 
prescriber must obtain and maintain records or evidence of 
affirmative consent by patients to electronic delivery of

[[Page 60789]]

their prescriptions. The burden to do so is included in the 
recordkeeping burden calculation of this PRA section.
    \470\ NPRM, 88 FR 283.
    \471\ AOA (CLR PRA Comment #0007 submitted by Benner).
    \472\ The survey found that approximately 57% said they used a 
separate signed confirmation form, 35% said they opted for digital 
delivery, 15% used a confirmation statement on a signed sales 
receipt, 27% used a confirmation statement on a signed prescription 
copy, and 9% selected ``other.'' As noted, prescribers were 
permitted to choose more than one option, so these percentages add 
up to more than 100%.
    \473\ Section 456.3(a)(3) also requires that in the event that a 
patient declines to sign a confirmation requested under paragraph 
(a)(1)(i) the prescriber must note the patient's refusal on the 
document and sign it. However, the Commission has no reason to 
believe that such notation should take any longer than for the 
patient to read and sign the document, so the Commission will 
maintain its calculation as if all confirmations requested under 
paragraph (a)(1)(i) require the same amount of time. It is worth 
noting that using the 82.5 million figure here is an overestimate by 
the Commission, since it does not deduct for the number of patients 
who visit a prescriber who does not have a direct or indirect 
financial interest in the sale of eye wear and would not be required 
to confirm receipt of prescriptions under Rule amendment Sec.  
456.4(c). However, staff does not currently possess information as 
to what number of prescribers will qualify for the exception in 
Sec.  456.4(c), and so has assumed that all patients receiving a 
prescription will either sign a confirmation of prescription release 
or a consent to receive their prescription electronically every 
year.
    \474\ See, e.g., 246 Mass. Code Regs. Sec.  3.02 (requiring 
optometrists to maintain patient records for at least seven years); 
Wash. Admin. Code Sec.  246-851-290 (requiring optometrists to 
maintain records of eye exams and prescriptions for at least five 
years); Iowa Admin. Code r. 645-182.2(2) (requiring optometrists to 
maintain patient records for at least five years).
    \475\ 20,625,000 prescriptions (82.5 million prescriptions x 
25%). As noted in section III.C., supra, prescribers may not need to 
obtain patient consents at every visit. But the Commission does not 
have reliable information as to the percentage of consumers that are 
new to their prescribers as opposed to being repeat visitors or how 
often prescribers' practices with digital prescription delivery will 
change and require new consents, and thus how many will or will not 
have to sign a consent-to-electronic-delivery. Thus, the Commission 
will assume, for PRA calculation purposes, that every time a 
consumer receives a digital prescription, the prescriber's staff has 
collected a signed consent. This very likely results in a 
significant overestimation of the consent burden.
    \476\ 20,625,000 prescriptions yearly x 20 seconds/60 secs/60 
mins.
    \477\ 20,625,000 affirmative consents x one minute/60 mins) for 
storing such records.
    \478\ This is further supported by comments during the Eyeglass 
Rule Workshop, such as that of panelist Dr. Montaquila, who noted 
that his staff completes the process ``from explaining why we're 
doing it to the patient, providing them with their prescription, 
making copies, providing their prescription back to them, and 
ultimately storing it. . . . Our staff has to explain, `You're 
signing this for this reason' '' Montaquila (WS Transcript at 22, 
28). See also Neville (WS Transcript at 28) (commenting that he has 
observed situations where the doctor pushed a button to have the 
prescription printed out at the front desk, the prescription was 
handed over at the desk by the staff person, and the staff person 
obtained the patient's signature on the confirmation); AOA Report 
for Complying with the FTC Contact Lens Rule, (survey to 
prescribers, Question 3, ``Have you experienced challenges in 
training staff on the new requirements for the Contact Lens Rule?''; 
Question 9 ``How much time per day does your staff spend on 
addressing patient questions with the acknowledgment form and 
process?'').
    \479\ Bureau of Labor Statistics, U.S. Department of Labor, 
Occupational Employment Statistics, https://www.bls.gov/news.release/ocwage.t01.htm.
    \480\ Based on information that there are approximately 61,000 
optometrists and ophthalmologists in the United States, this 
averages to $629 per prescriber per year.
    \481\ The Vision Council, Market inSights 2022. Total market 
value of eyeglass frames and lenses. Does not include exams, reading 
glasses, or contact lenses. The $149,691,431 cost of the Eyeglass 
Rule is 0.0042 of the total $35.6 billion market value.
    \482\ It is possible that bringing the prescription confirmation 
requirements for eyeglass prescriptions into conformity with those 
for contact lenses will ease staff training burdens rather than 
increase them, since prescribers' staff will not have to learn to 
differentiate between the two types and treat them differently for 
rule purposes.
    \483\ As explained in the PRA Section, supra, the Commission 
calculates an incremental burden of $38,389,993 from adding the 
confirmation of prescription release to the Eyeglass Rule. The 
Commission need not issue a final regulatory analysis under section 
22 of the FTC Act because this amount does not meet the threshold of 
an annual effect on the national economy from the amendment of $100 
million or more or cause the other changes or effects described in 
section 22(a)(1)(B) and (C). See 15 U.S.C. 57b-3.
    \484\ NAROC (WS Comment #0049 submitted by Neville).
    \485\ See section VIII, supra.
    \486\ See 13 CFR 121.201 (Small Business Size Regulations).
    \487\ See NPRM, 88 FR 285.
    \488\ AOA (NPRM Comment #0023 submitted by Benner).
    \489\ According to one publication, 65% of optometrists work in 
a practice owned by an optometrist or ophthalmologist, practices 
that are likely small businesses. See AOA, ``An Action-Oriented 
Analysis of the State of the Optometric Profession: 2013,'' at 7 
https://reviewob.com/wp-content/uploads/2016/11/8-21-13stateofoptometryreport.pdf. This publication also reported that 
although it could not ascertain the precise number of independent 
optometric practices, it estimated that as of 2012, there were 
14,000 to 16,000 optometric businesses with no corporate or 
institutional affiliation. Id.
    \490\ NPRM, 88 FR 264.
    \491\ Id. at 263.
    \492\ NPRM, 88 FR 287.

[FR Doc. 2024-15620 Filed 7-25-24; 8:45 am]
BILLING CODE 6750-01-P