Rule2024-15620
Ophthalmic Practice Rules (Eyeglass Rule)
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 26, 2024
Effective
September 24, 2024
Issuing agencies
Federal Trade Commission
Abstract
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.
Full Text
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-15620]
[[Page 60741]]
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
[[Page 60742]]
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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)
[[Page 60743]]
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
[[Page 60744]]
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,
[[Page 60745]]
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
<a href="http://GlassesUSA.com">GlassesUSA.com</a>.
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
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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
<a href="http://Eyeglasses.com">Eyeglasses.com</a> 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 <a href="http://Eyeglass.com">Eyeglass.com</a>, 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 a
[…truncated; see source link]Indexed from Federal Register on July 26, 2024.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.