Federal Register, Volume 88 Issue 1 (Tuesday, January 3, 2023)

[Federal Register Volume 88, Number 1 (Tuesday, January 3, 2023)]
[Proposed Rules]
[Pages 248-287]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-27828]

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Vol. 88

Tuesday,

No. 1

January 3, 2023

Part III

Federal Trade Commission

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16 CFR Part 456

Ophthalmic Practice Rules (Eyeglass Rule); Proposed Rule

Federal Register / Vol. 88 , No. 1 / Tuesday, January 3, 2023 /
Proposed Rules

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FEDERAL TRADE COMMISSION

16 CFR Part 456

RIN 3084-AB37

Ophthalmic Practice Rules (Eyeglass Rule)

AGENCY: Federal Trade Commission.

ACTION: Notice of proposed rulemaking; request for public comment.

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SUMMARY: The Federal Trade Commission (``FTC'' or ``Commission'')
proposes to amend the Ophthalmic Practice Rules (``Eyeglass Rule '' or
``Rule'') to 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. The
Commission also proposes to permit prescribers to comply with automatic
prescription release via electronic delivery in certain circumstances.
The Commission further proposes a clarification 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 proposes to amend the term ``eye examination'' to
``refractive eye examination'' throughout the Rule. The Commission
seeks comment on these proposals.

DATES: Written comments must be received on or before March 6, 2023.

ADDRESSES: Interested parties may file a comment online or on paper by
following the instructions in the Request for Comment part of the
SUPPLEMENTARY INFORMATION section below. Write ``Eyeglass Rule, Project
No. R511996'' on your comment, and file your comment through https://www.regulations.gov. If you prefer to file your comment on paper, write
``Eyeglass Rule, Project No. R511996'' on your comment and on the
envelope and mail your comment to the following address: Federal Trade
Commission, Office of the Secretary, 600 Pennsylvania Avenue NW, Suite
CC-5610 (Annex C), Washington, DC 20580.

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

SUPPLEMENTARY INFORMATION: The Commission finds that using the
procedures set forth in this notice of proposed rulemaking will serve
the public interest by supporting the Commission's goals of clarifying
and updating existing regulations without undue expenditure of
resources, while ensuring that the public has an opportunity to submit
data, views, and arguments on whether the Commission should amend the
Rule. The Commission, therefore, has determined, pursuant to 16 CFR
1.20, to use the following procedures: (1) publishing this notice of
proposed rulemaking; (2) soliciting written comments on the
Commission's proposals to amend the Rule; (3) holding a workshop; and
(4) announcing final Commission action in a document to be published in
the Federal Register.
The Commission will host a workshop to gather additional public
input regarding the proposed changes. After publishing this notice of
proposed rulemaking (``NPRM''), the Commission will publish a document
in the Federal Register announcing the workshop and providing
instructions on how interested persons may request an opportunity to
participate.
The Commission, in its discretion, has not chosen to schedule an
informal hearing and has not made any initial designations of disputed
issues of material fact necessary to be resolved at an informal
hearing. The Commission believes that a workshop will provide
sufficient opportunity for obtaining additional public input on its
proposal. Interested persons who wish to make an oral submission at an
informal hearing must file a comment in response to this NPRM and
submit a statement identifying their interests in the proceeding and
describing any proposals regarding the designation of disputed issues
of material fact to be resolved at the informal hearing, on or before
March 6, 2023. 16 CFR 1.11. Such requests, and any other motions or
petitions in connection with this proceeding must be filed with the
Secretary of the Commission.

Table of Contents

I. Background
A. Overview of the Eyeglass Rule
B. History of the Rule
1. Eyeglass I Report and Rule
2. Eyeglass II Report and Rule
3. The 1997 to 2004 Eyeglass Rule Review
4. The 2015 to 2020 Contact Lens Rule Review
C. The Evolving Eyeglass Marketplace
D. State Regulation of the Sale of Eyeglasses
II. Eyeglass Rule Review
A. Evidentiary Standard
B. Overview of Comments in Response to ANPR
III. Requirements for Eyeglass Sellers
IV. Section 456.2--Separation of Examination and Dispensing
A. Automatic Prescription Release
1. Comments on Whether To Retain Automatic Prescription Release
2. Compliance With the Automatic Prescription Release
Requirement
3. Evidence Regarding Consumers' Awareness of Their Right To
Receive Their Prescription
4. Analysis of Evidence Regarding Automatic Prescription Release
Provision
5. Proposals for Improving Compliance and Consumer Awareness
a. Proposal To Increase Enforcement
b. Proposal To Require an Eye Care Patients' Bill of Rights
c. Proposal To Require Signage
d. Proposal To Require a Confirmation of Prescription Release
6. The Commission's Proposal To Require a Signed Confirmation of
Prescription Release
B. Other Issues Surrounding Patients' Access To Eyeglass
Prescriptions
1. Prescriber Responsibilities To Provide Additional Copies of
Prescriptions
a. Analysis of Whether To Require Provision of Additional Copies
of Prescriptions Upon Request
b. Analysis of Whether To Permit Prescribers to Charge Fees for
Provision of Additional Copies of Prescriptions
2. Electronic Delivery of Prescriptions as a Means for Automatic
Prescription Release Under Section 456.2(a)
a. The Commission's Proposal To Add a Definition to Section
456.1 To Permit Electronic Delivery of the Patient's Prescription
b. Technological Advances That May Improve Prescription
Portability
c. HIPAA Concerns Regarding Emailed Prescriptions
3. Insurance Coverage as Payment Under Section 456.2(a)
C. Requiring Prescribers To Respond to Authorized Third-Party
Seller Requests for a Copy of Prescription or Verification of
Prescription Information
1. Comments on Requiring Prescriber Response to Third-Party
Seller Requests
2. Analysis of Whether To Amend the Rule to Require Prescriber
Response
V. Prescription Requirements
A. Requiring Prescribers To Include Pupillary Distance on
Eyeglass
Prescriptions
1. Comments on Whether To Require Pupillary Distance
2. Analysis of Whether to Amend the Rule To Require Pupillary
Distance
B. Amending the Rule To Set an Expiration Date for Eyeglass
Prescriptions
C. Amending Other Rule Definitions
VI. Recommendations Regarding the Commission's Complaint System
VII. Request for Comment
VIII. Communications by Outside Parties to the Commissioners or
Their Advisors
IX. Paperwork Reduction Act
A. Estimated Burden
B. Estimated Labor Cost
C. Capital and Other Non-Labor Costs
X. Preliminary Regulatory Analysis and Regulatory Flexibility Act
Requirements
A. Description of the Reasons the Agency Is Taking Action

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B. Statement of the Objectives of, and Legal Basis for, the
Proposed Amendments
C. Small Entities to Which the Proposed Amendments Will Apply
D. Projected Reporting, Recordkeeping, and Other Compliance
Requirements, Including Classes of Covered Small Entities and
Professional Skills Needed To Comply
E. Duplicative, Overlapping, or Conflicting Federal Rules
F. Significant Alternatives to the Proposed Amendments
Proposed Rule Language

I. Background

A. Overview of the Eyeglass Rule

The Eyeglass Rule 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 to
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\
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\1\ 16 CFR 456.2(a). A prescriber may withhold a patient's
prescription until the patient has paid for the eye examination, but
only if the prescriber would have required immediate payment if the
examination had revealed that no ophthalmic goods were needed. Id.
\2\ 16 CFR 456.2(c).
\3\ 16 CFR 456.1(g).
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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 deems it an unfair act
or practice for the prescriber to place on the prescription, or require
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\
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\4\ 16 CFR 456.2(b). The Rule thereby also prohibits
conditioning the release of the prescription on the requirement that
the patient purchase ophthalmic goods from the ophthalmologist or
optometrist.
\5\ 16 CFR 456.2(d).
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B. History of the Rule

The FTC has decades of regulatory and research experience with the
optical goods industry, which continues to inform the basis and purpose
of the Rule and this NPRM. The Commission's engagement in the industry
predates formal adoption of the Eyeglass Rule. In 1962, the Commission
first took steps to protect consumers and foster competition in the
sale of eyeglasses by adopting the ``Guides for the Optical Products
Industry,'' which included a provision declaring it an unfair trade
practice to ``tie in or condition'' refraction services to the
dispensing of eyeglasses when such a practice has a ``reasonable
probability'' of harming competition.\6\ Among the conduct considered
unfair were charging a higher or additional fee if the patient wanted
to take the prescription elsewhere to buy eyeglasses, and refusing to
perform examinations if the patient wanted to take the prescription
elsewhere.\7\ The Guides were not binding, however, and the FTC never
undertook litigation to enforce them,\8\ even though prescribers
routinely violated the directives.\9\
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\6\ 16 CFR 192 (rescinded); see also ``Staff Report on
Advertising of Ophthalmic Goods and Services and Proposed Trade
Regulation Rule,'' 235-36 (1977), https://www.ftc.gov/reports/staff-report-advertising-ophthalmic-goods-services-proposed-trade-regulation-rule-16-cfr-part-456?msclkid=957f749bc63711ecaefb4944debc75db [hereinafter Eyeglass I
Report].
\7\ Eyeglass I Report, supra note 6, at 235-36.
\8\ Id.
\9\ See id. at 240-48 (detailing myriad accounts of prescribers
refusing to release eyeglass prescriptions to their patients); see
also Final Trade Regulation Rule, Advertising of Ophthalmic Goods
and Services, 43 FR 23992, 23998 (June 2, 1978) [hereinafter
Eyeglass I Rule] (finding that in nearly every survey of practicing
optometrists considered in the rulemaking record, more than 50
percent imposed a restriction on the availability of eyeglass
prescriptions to patients).
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1. Eyeglass I Report and Rule
On September 16, 1975, the Commission directed its staff to examine
the retail ophthalmic market, including whether prescribers were tying
eyeglass dispensing to examination, and whether such practices harmed
consumers.\10\ Staff surveyed state laws and regulations, and solicited
comment from a variety of interested parties, including ophthalmic
licensing boards, professional associations, and consumer groups.\11\
The Commission then sought comment on a proposed rule to eliminate
certain advertising restraints on ophthalmic goods and services, and
indicated that if evidence showed that consumers were being prevented
from price shopping--due to the unavailability of prescriptions--the
Commission might require prescribers to give patients copies.\12\
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\10\ Eyeglass I Report, supra note 6, at 1.
\11\ Id.
\12\ Id.
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FTC staff subsequently released its Eyeglass I Report detailing
practices that prescribers used to discourage consumers from taking
prescriptions to be filled elsewhere, including (1) outright refusal to
release prescriptions or refusal to conduct examinations unless the
patient agreed to purchase eyeglasses; (2) charging an additional fee
as a condition to releasing the prescription; and (3) conditioning the
release of the prescription on the patient signing a release or waiver
of liability.\13\ Staff explained that significant evidence--including
testimony from optometrists, patients, and consumer groups, as well as
prescriber surveys and published statements from boards of optometry
and opticians--established that such practices were a serious and
pervasive problem.\14\ The Report concluded that refusal to release
prescriptions, or placing conditions on their release, constituted an
unfair act or practice, and recommended that the Commission promulgate
a rule ``insuring consumers unconditional access to their ophthalmic
prescriptions.'' \15\
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\13\ Id. at 241. With respect to liability waivers and releases,
the Eyeglass I Report concluded that there could be ``little doubt''
that their primary intent was to discourage or dissuade consumers
from taking their eyeglass prescriptions elsewhere to be filled. Id.
at 277.
\14\ Id. at 241-45, 252-54.
\15\ Id. at 259, 263-65.
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On June 2, 1978, the Commission issued the Advertising of
Ophthalmic Goods and Services Rule (the ``Eyeglass I Rule''), which,
among other things, contained a provision titled ``Separation of
Examination and Dispensing'' requiring prescribers to automatically
release prescriptions to their patients--regardless of whether or not
the patients requested them--to ensure consumers unconditional access
to their prescriptions so they could comparison-shop for
eyeglasses.\16\ In the Rule's Statement of Basis and Purpose, the
Commission explained that evidence conclusively established that
consumers suffered substantial economic loss through the imposition of
surcharges for obtaining their prescriptions, and through lost
opportunity costs arising from an inability to comparison-shop for
eyeglasses.\17\ Furthermore, the Commission found that prescribers' use
of waiver notices and disclaimers deceived consumers as to the
capabilities of other optical dispensaries, and further restricted
purchase options.\18\ Such practices offended public policy in that
they denied consumers the ability to effectively use available
information,

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and inhibited competition in retail eyeglasses markets.\19\
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\16\ Eyeglass I Rule, 43 FR 23992, 23998, 24007-08.
\17\ Id. at 24003.
\18\ Id.
\19\ Id.
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The Commission added that while it considered only requiring
prescription release upon consumer request, it opted instead for so-
called ``automatic release'' due to consumers' lack of awareness that
they could purchase eyeglasses elsewhere, and because absent automatic
release, there might be ``evidentiary squabbles'' over whether
consumers did or did not request their prescription.\20\ In addition,
the Commission noted there was no evidence to suggest automatic release
would impose a significant burden on prescribers.\21\
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\20\ Id. at 23998.
\21\ Id.
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After issuance of the Eyeglass I Rule, the American Optometric
Association (``AOA''), representing most of the country's optometrists,
challenged it, and in 1980 the D.C. Circuit overturned Rule provisions
pertaining to advertising restrictions.\22\ The court, however, upheld
the automatic prescription release requirement, finding there was ample
evidence that withholding prescriptions harmed consumers by making
comparison-shopping harder, removing incentives for ophthalmic goods
sellers to advertise, and reducing opticians' ability to compete.\23\
The court also noted there was considerable evidence that prescribers
had used waivers and liability disclaimers ``to discourage comparison
shopping, to mislead consumers . . ., and to frighten consumers into
purchasing ophthalmic goods and services'' from the prescriber.\24\
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\22\ Am. Optometric Ass'n v. FTC, 626 F.2d 896, 910-11 (D.C.
Cir. 1980).
\23\ Am. Optometric Ass'n, 626 F.2d at 915.
\24\ Id. at 916.
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2. Eyeglass II Report and Rule
Following the court's remand of the Eyeglass I Rule, FTC staff
conducted further investigation, and in 1980 issued a staff report
entitled ``State Restrictions on Vision Care Providers: The Effects on
Consumers (``1980 Staff Report'').\25\ The 1980 Staff Report did not
make recommendations regarding the automatic prescription release
provision, but instead suggested the Commission seek comment on whether
to change it to release upon request, or to sunset the release
requirement altogether.\26\
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\25\ ``State Restrictions on Vision Care Providers: The Effects
on Consumers'' (1980), https://www.ftc.gov/reports/state-restrictions-vision-care-providers-effects-consumers-eyeglasses-ii
\26\ Id. at 248-49. The 1980 Staff Report, however, did propose
extending the automatic release requirement to cover eyeglass
dispensers, so that opticians--as well as optometrists and other
eyeglass dispensers--would be required to return prescriptions to
patients after fabricating the eyeglasses. Id. at 133, 260-61. The
aim of staff's proposal was to guarantee patients access to their
prescriptions even after they had been filled, and to ensure that
consumers retained a copy so they could obtain duplicate glasses
later without having to return to their original prescriber or
eyeglass dispenser. Id. at 134, 261-64. Staff later reversed course
on this proposal, however, after determining that there was
insufficient evidence that dispensers were refusing to return
prescriptions to patients. The Commission chose not to adopt the
proposal. See ``Ophthalmic Practice Rules: State Restrictions on
Commercial Practice,'' 250, 300-02 (1986), https://www.ftc.gov/reports/ophthalmic-practice-rules-state-restrictions-commercial-practice-eyeglasses-ii-report-staff [hereinafter Eyeglass II
Report]; Final Trade Regulation Rule, Ophthalmic Practice Rules, 54
FR 10285, 10303 (Mar. 13, 1989) [hereinafter Eyeglass II Rule].
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Following the 1980 Staff Report, the Commission sponsored a survey
to determine to what extent prescribers were complying with the Rule.
The survey, commonly known as the ``Market Facts Study,'' found that
only about one-third of prescribers automatically provided patients
with prescriptions.\27\ Thus, the majority of prescribers were not in
compliance. The survey also found that only 38 percent of consumers
knew they were entitled to receive their prescription
automatically.\28\ The survey found, however, that when consumers
requested their prescriptions, by and large prescribers no longer
refused to release them,\29\ and that a majority of consumers had
become ``generally knowledgeable'' about the availability of eyeglass
prescriptions, appearing to know they could request one.\30\
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\27\ Eyeglass II Report, supra note 26, at 256.
\28\ Id. at 258. Forty-six percent wrongly believed they were
entitled to the prescription only upon request, and 18 percent
wrongly believed that prescribers were permitted to charge extra if
the patient asked for the prescription. Id.
\29\ Id. at 253-62.
\30\ Id.
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Five years later, the Commission again reviewed the Rule and sought
comment on whether consumers were aware of their right to obtain their
prescription,\31\ and whether the automatic release provision ought to
be terminated, changed to release upon request, or changed to require
that prescribers simply ``offer'' patients their prescriptions rather
than automatically provide them.\32\ After public hearings, the hearing
officer issued a report to the Commission (``Presiding Officer's
Report'') \33\ finding that, although most prescribers would release
prescriptions upon request, many were still not releasing them
automatically. Accordingly, the presiding officer recommended that the
automatic release requirement not be modified or terminated.\34\
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\31\ Ophthalmic Practice Rules, Notice of Proposed Rulemaking,
50 FR 598, 602 (Jan. 4, 1985).
\32\ The Commission received significant comment and evidence on
whether to maintain automatic prescription release, repeal it, or
change it to release upon request, but very little comment or
evidence regarding the option of offering patients prescriptions.
Eyeglass II Rule, 54 FR 10285, 10303 & n.182.
\33\ Report of the Presiding Officer on Proposed Regulation
Rule: Ophthalmic Practice Rules, Public Record No. 215-63 (May 1,
1986), https://www.ftc.gov/reports/report-presiding-officer-proposed-trade-regulation-rule-ophthalmic-practice-rules-eyeglass-rule-16?msclkid=c8131b8ac63911ecb89f5b16ef81c791.
\34\ Id.
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In contrast, FTC staff issued its own report (``Eyeglass II
Report''), which proposed changing the release provision from automatic
release to release upon request.\35\ Staff based its proposal on what
it perceived to be altered market conditions and increased consumer
awareness, as well as the difficulty staff had encountered enforcing
the automatic release provision.\36\ According to staff, the automatic
release requirement had not succeeded at ``avoiding evidentiary
squabbles,'' \37\ but rather had increased them, since whether a
prescriber had released a prescription could not, in most cases, be
ascertained by documentary evidence.\38\
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\35\ Eyeglass II Report, supra note 26, at 249.
\36\ Id. at 249, 274-276.
\37\ Eyeglass I Rule, 43 FR 23992, 23998.
\38\ Eyeglass II Report, supra note 26, at 275-76.
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Despite staff's recommendation, the Commission, in its final rule--
referred to as the ``Eyeglass II Rule''--sided with the Presiding
Officer and opted to retain the automatic release component.\39\ As the
basis for its decision, the Commission cited the comments and testimony
about continued prescriber non-compliance,\40\ as well as the Market
Facts Study and findings of the Presiding Officer, which established
that many prescribers were not automatically providing prescriptions as
required.\41\ The Commission also cited an additional survey submitted
by the American Association of Retired Persons (``AARP''), which found
significant non-compliance and lack of consumer awareness, particularly
among older consumers.\42\
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\39\ Eyeglass II Rule, 54 FR 10285, 10286-87.
\40\ Id. at 10303.
\41\ Id. at 10313 & nn.180 & 181; see also Eyeglass II Report,
supra note 26, at 255-58 (reporting the Market Facts Study results).
\42\ Eyeglass II Rule, 54 FR 10285, 10303 nn.180 & 181; see also
Eyeglass II Report, supra note 26, at 263 (reporting that the AARP
survey of older Americans found that 47 percent did not receive a
copy of their prescription, and 32 percent of those did not know to
ask for one).
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The Eyeglass II Rule was again challenged by the optometric
industry and, in 1990, much of the Rule was

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vacated, but not the prescription release requirements, which remained
in effect.\43\
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\43\ See Cal. State Bd. of Optometry v. FTC, 910 F.2d 976 (D.C.
Cir. 1990). The decision focused on a determination that the FTC
lacked statutory authority to declare state laws of optometry to be
unfair acts or practices without more explicit authority from
Congress. Following the court decision, the Commission, in 1992,
reissued the Eyeglass Rule, but without the portions declared
invalid, and with renumbered designations pertaining to prescription
release. See Final Trade Regulation Rule, Ophthalmic Practice Rules,
57 FR 18822 (May 1, 1992).
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3. The 1997 to 2004 Eyeglass Rule Review
In 1997, as part of its systematic review of its rules and
regulations, the Commission again requested comment on whether the
Rule's prescription release requirement should be retained, modified,
or eliminated.\44\ The Commission received comments from numerous
parties but withheld taking action while it considered whether contact
lenses should be covered by the Rule. Ultimately, after Congress passed
the Fairness to Contact Lens Consumers Act (``FCLCA''),\45\ the
Commission issued a separate Contact Lens Rule (``CLR'') with
prescription release requirements similar, in most respects, to those
required by the Eyeglass Rule.\46\ When the Commission turned again to
the Eyeglass Rule and its prescription release requirement, it held
that evidence in the rulemaking record suggested that prescribers
continued to refuse to release eyeglass prescriptions, even though such
conduct had been unlawful for nearly 25 years.\47\ The Commission
opined that were it to eliminate the prescription release requirement,
even more prescribers might refuse to release prescriptions and thereby
benefit from inducing patients to purchase eyeglasses from them.\48\
Due to this possibility, and because it found the release of
prescriptions enhances consumer choice at minimal compliance cost to
prescribers, the Commission opted to retain the prescription release
requirement.\49\
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\44\ Ophthalmic Practice Rules, Request for Comments, 62 FR
15865, 15867 (Apr. 3, 1997).
\45\ 15 U.S.C. 7601-7610 (Pub. L. 108-164).
\46\ Contact Lens Rule, 16 CFR part 315.
\47\ Ophthalmic Practice Rules, Final Rule, 69 FR 5451, 5453
(Feb. 4, 2004).
\48\ Id.
\49\ Id.
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Furthermore, after reviewing the record and finding that some
consumers still were not aware of their right to obtain their
prescription, the Commission decided not to modify the Rule to require
release upon request. The Commission stated that absent automatic
release, consumers unaware of their right would not know to request
their prescription, or their prescriber might discourage them from
doing so.\50\ In light of these considerations, the Commission
determined to retain the Rule in its existing form.\51\ In so doing,
the Commission also ensured that prescription release requirements for
eyeglasses would align with those for contact lenses under the Contact
Lens Rule.\52\
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\50\ Id. The Commission also made findings that: release of
prescriptions enhances consumer choice; no evidence had been
submitted that the Rule's restrictions on disclaimers and waivers
were no longer needed; the automatic release provision imposed only
a minimal burden on prescribers; and retaining automatic release
would keep the Eyeglass Rule consistent with the automatic release
provision of the Contact Lens Rule, promulgated in 2004 pursuant to
the Fairness to Contact Lens Consumers Act of 2003. Id.; see also
Contact Lens Rule, 16 CFR part 315; Fairness to Contact Lens
Consumers Act, 15 U.S.C. 7601-7610.
\51\ Ophthalmic Practice Rules, 69 FR 5451, 5453.
\52\ Id. See also Contact Lens Rule, 69 FR 40482 (July 2, 2004)
(codified at 16 CFR part 315).
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4. The 2015 to 2020 Contact Lens Rule Review
As part of its periodic review of rules and guides, the Commission,
on September 3, 2015, initiated a review of the Contact Lens Rule,
including its prescription release requirement.\53\ While the Contact
Lens Rule 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.
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\53\ Contact Lens Rule, Request for Comment, 80 FR 53272 (Sept.
3, 2015) [hereinafter CLR RFC].
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During its review of the CLR, the Commission considered more than
8,000 public comments as it put forth a notice of proposed rulemaking
\54\ and supplemental notice of proposed rulemaking \55\ before issuing
an amended final rule on August 17, 2020.\56\ In its CLR final rule,
the Commission determined that the evidentiary record, as well as the
Commission's enforcement and oversight experience, supports the view
that prescriber compliance with the automatic prescription release
requirement is sub-optimal, and, as a result, that millions of
consumers are still not receiving their contact lens prescriptions as
required by law.\57\ The Commission further found that many consumers
remain unaware that they even have a right to receive their
prescriptions.\58\ To remedy this, the Commission implemented a
Confirmation of Prescription Release provision, requiring that
prescribers request that a patient confirm receipt of their contact
lens prescription.\59\ According to the Commission, the patient
confirmation requirement should result in, among other things, an
increase in the number of patients in possession of their contact lens
prescription and improved flexibility and choice for consumers,
ultimately fostering improved competition in the market, more efficient
contact lens sales, and lower prices for consumers.\60\ The Commission
also noted that the requirement would increase the Commission's ability
to enforce and assess the CLR.\61\
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\54\ Contact Lens Rule, Notice of Proposed Rulemaking, 81 FR
88526 (Dec. 7, 2016) [hereinafter CLR NPRM].
\55\ Contact Lens Rule, Supplemental Notice of Proposed
Rulemaking, 84 FR 24664 (May 28, 2019) [hereinafter CLR SNPRM].
\56\ Contact Lens Rule, Final Rule, 85 FR 50668 (Aug. 17, 2020)
[hereinafter CLR Final Rule].
\57\ Id. at 50687.
\58\ Id.
\59\ 16 CFR 315.3(c).
\60\ CLR Final Rule, 85 FR 50668, 50687.
\61\ Id.
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C. The Evolving Eyeglass Marketplace

The retail vision care industry in the United States consists of
several different kinds of participants, namely ophthalmologists,
optometrists, opticians, and eyewear retailers. The services provided
by these different participants often overlap, and the 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 medical school, a year of general internship,
and an additional three years of specialized hospital residency
training in ophthalmology. It is estimated that there are approximately
19,000 active ophthalmologists in the United States.\62\ Many
ophthalmologists, especially those who further specialize,\63\ do not
sell eyewear, although some do.
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\62\ American Academy of Ophthalmology (``AAO''), ``Eye Health
Statistics,'' https://www.aao.org/newsroom/eye-health-statistics.
\63\ According to the AAO, ``[s]ubspecialists have intensive
training in a particular area of the eye. To become subspecialists,
ophthalmologists add a fellowship to their years of medical
training. A fellowship prepares an ophthalmologist to treat more
specific or complex conditions in certain parts of the eye or in
certain types of patients.'' AAO, ``Ophthalmology Subspecialists''
(June 6, 2016), https://www.aao.org/eye-health/tips-prevention/ophthalmology-subspecialists.

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Optometrists are doctors of optometry. They have not completed
medical school, but have instead completed four years of training in
optometry school, following three or more years of college. They are
trained and licensed to examine eyes, diagnose refractive problems,
prescribe and dispense eyeglasses and contact lenses, and detect eye
disease.\64\ 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 indicates that in 2020 there were approximately 43,000 active
optometrists in the United States.\65\ While professional services,
such as eye health and refraction examinations, generate significant
revenue for optometrists, most optometrists still derive a larger
percentage of their income from product sales, including the sale of
eyeglasses and contact lenses.\66\ According to some estimates, product
sales typically account for 55 to 65 percent of optometrist
revenue.\67\
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\64\ In some states, optometrists can prescribe medicine and
perform certain surgeries. AOA, ``What's a doctor of optometry?''
https://www.aoa.org/healthy-eyes/whats-a-doctor-of-optometry?sso=y.
\65\ Bureau of Labor Statistics, U.S. Dep't of Labor,
Occupational Outlook Handbook, Optometrists, https://www.bls.gov/ooh/healthcare/optometrists.htm (visited Apr. 27, 2022).
\66\ ECP University, ``Key Metrics: Assessing Optometric
Practice Performance & Best Practices of Spectacle Lens Management
Report,'' 25 (March 22, 2018), https://ecpu.com/media//wysiwyg/docs/ECPU_MBA_KeyMetricsReport_2018.pdf (``Independent optometric
practices derive 35% of revenue from professional fees and 65% from
product sales, including 37% from [eyeglasses] and 17% from contact
lens sales''); Rev. Optm. Bus., ``Challenges and Opportunities in
the Future of Independent Optometry,'' 3 (April/May 2013), https://www.reviewob.com/wp-content/uploads/2016/11/paa_visionsource__0413.pdf (stating that device sales remain the
dominant revenue producer in most practices, typically accounting
for 55 to 65 percent of revenue).
\67\ Id. See also Margery Weinstein, ``Key Practice Metrics:
Numbers to Track & Grow to Help Speed Practice Recovery,'' Rev.
Optm. Bus., https://www.reviewob.com/key-practice-metrics-numbers-to-track-grow-to-speed-practice-recovery/ (citing Care Credit,
Independent Optometry Key Performance Metrics: 2019 Trend Report at
5, 9, and noting that product sales in 2019 continued to account for
the majority of gross revenue (54%), but that eyeglass sales dropped
from 42% of gross revenue in 2018 to 37% in 2019).
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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.
Twenty-one states currently require opticians to obtain licenses,\68\
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 government estimate indicates that there are
approximately 70,000 active opticians in the United States.\69\
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\68\ OpticianEDU.org, ``Optician Certification,'' https://www.opticianedu.org/optician-certification/.
\69\ Bureau of Labor Statistics, U.S. Dep't of Labor,
Occupational Outlook Handbook, Opticians, https://www.bls.gov/ooh/healthcare/opticians-dispensing.htm (visited Apr. 27, 2022).
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Eyewear retailers are companies and independent merchants that sell
eyeglasses. 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 \70\), 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 Warby Parker and Zenni
Optical.
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\70\ Vision Council, ``VisionWatch--The Vision Council Market
Analysis Report,'' Dec. 2019 [hereinafter VisionWatch Report], at
17.
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The overall retail eyeglass market continues to experience growth
in both the number of eyeglass wearers as well as the number of
eyeglasses purchased. As of December 2019, approximately 165 million
American adults were regularly wearing prescription eyeglasses,
representing nearly two-thirds of the country's adult populace.\71\ In
addition, some 30 percent of eyeglass wearers used two or more pairs
interchangeably on a regular basis.\72\
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\71\ VisionWatch Report, supra note 70, at 24; see generally
Vision Council, ``U.S. Optical Overview and Outlook,'' Dec. 2015, at
4-5 (discussing the growth of eyeglass usage from 2006 to 2015).
\72\ VisionWatch Report, supra note 70, at 43.
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Overall, in 2019, consumers purchased approximately 79 million
pairs of eyeglass frames, and 88 million pairs of lenses \73\ for a
total sales volume of roughly $10 billion in frames and $14.3 billion
in lenses.\74\ Of total sales, the largest portion--at least in terms
of dollars spent--occurred at independent optical retailers, who
accounted for approximately 50 percent of U.S. eyeglass frame and lens
sales in 2019.\75\ Conventional optical chain stores accounted for
approximately 27.5 percent of eyeglass frame and lens sales (in
dollars), and mass merchandisers accounted for approximately 10 percent
of eyeglass frame and lens sales (in dollars).\76\
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\73\ In 2019, about 89 percent of prescription lenses were
purchased as a complete pair of eyeglasses (frames and lenses),
representing about 78.3 million pairs of prescription eyeglasses.
VisionWatch Report, supra note 70, at 11, 12, 60. By comparison, in
1975, American consumers purchased approximately 53 million pairs of
prescription eyeglasses. Eyeglass I Report, supra note 6, at 11-12.
\74\ Vision Council, ``Consumer Barometer,'' Dec. 2019, at 2,
18-19.
\75\ Id. at 18-19.
\76\ Id. Optical centers in department stores accounted for
approximately two percent of frame and lens sales (in dollars). Id.
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Online sales of eyeglasses remain a small portion of the optical
market. According to one industry publication, as of June 2019 just
five percent of sales (in dollars) of eyeglass frames derived from
online sales during the previous year.\77\ Consumers purchased
approximately seven and a half million pairs of frames online,
representing about 9.4 percent of all pairs of frames sold, in the 12
months ending June 2019.\78\ But although online sales are still
relatively small, they continue to increase steadily. Total online
sales (in dollars) for all vision care products rose 7.7 percent
between mid-2018 and 2019,\79\ while online sales (in dollars) of
frames grew 8.1 percent and of prescription lenses grew 10.8 percent in
2019.\80\ A primary driver for the increase in online sales may be
lower pricing. According to an industry source, as of 2015 online
sellers were typically 50 to 60 percent less expensive than brick and
mortar eyeglass retailers.\81\ More recently, the COVID-19 pandemic may
have spurred a greater

[[Page 253]]

number of consumers to shop for eyeglasses online, or to delay eyewear
purchases altogether, but the long-term impact of the pandemic on
consumer purchasing decisions is unknown. A study commissioned by The
Vision Council showed that, in March 2020, when the World Health
Organization declared COVID-19 a pandemic, over 25% of consumers stated
an intention to buy eyewear online to limit human interaction and
physical contact, more than double the number who planned to shop
online before COVID-19.\82\
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\77\ Vision Council, ``U.S. Optical Market Optical Overview,''
Sept. 2019, at 12. The industry report does not specify whether the
frames were purchased with prescription lenses or by themselves.
Other data from the Vision Council, however, indicate that
distribution percentages for sales of refractive lenses are nearly
identical to that of frames, suggesting that the overall percentage
of complete eyeglasses (frames and lenses) purchased online is about
5 percent of total sales (in dollars). Vision Council, ``Consumer
Barometer,'' Dec. 2019, at 18-19. By comparison, approximately 15
percent of sales (in dollars) of contact lenses now derive from
online sales. Vision Council, ``U.S. Optical Market Optical
Overview,'' Sept. 2019, at 3, 6.
\78\ Vision Council, ``U.S. Optical Market Optical Overview,''
Sept. 2019, at 7.
\79\ See id. at 6.
\80\ Vision Council, ``Consumer Barometer,'' Dec. 2019, at 18-
19.
\81\ Vision Council, ``U.S. Optical Overview and Outlook,''
supra note 71, at 65 n.3.
\82\ Vision Council, ``Researching Recovery: Exploring Evolving
Consumer Behavior and Industry Response During COVID-19,'' May 21,
2020, at 38 (reporting results of VisionWatch Insights study),
available at https://thevisioncouncil.org/sites/default/files/assets/media/TVC-COVID-19-VisionWatch-Consumer-Industry-Research_Member-Insights-Webinar-5-21-2020_w-Notes.pdf.
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D. State Regulation of the Sale of Eyeglasses

As detailed above, the purpose of the Eyeglass Rule is to
facilitate consumer choice and foster competition by separating the
functions of the eye examination and the dispensing of prescribed
eyeglasses. The Rule accomplishes this separation by requiring that
prescribers provide consumers with a copy of their eyeglass
prescription at the conclusion of the eye examination, and by
prohibiting certain restrictions on the release of the prescription.
The Eyeglass Rule, however, regulates only the release of the eyeglass
prescription, and does not regulate other aspects of the practice of
ophthalmology, optometry, or opticianry.\83\
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\83\ For example, although the Eyeglass Rule contains a
definition of ``prescription,'' the purpose of the definition is to
effectuate the separation of the exam and the sale of eyeglasses.
The Rule's definition is not intended to preempt state regulations.
See 16 CFR 456.1(g).
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State laws and regulations govern most aspects of professional
practice and eyewear sales. Typically, individual state licensing
boards are responsible for the licensing and oversight of
ophthalmologists, optometrists, and opticians and, often, the
dispensing of prescribed eyeglasses. These state regulatory frameworks
vary widely. Some states have comprehensive regulatory frameworks that
govern every aspect of dispensing prescribed eyeglasses: such
regulations set forth the required components of an eyeglass
prescription, the length and expiration date of an eyeglass
prescription, and the allowable modes to transmit eyeglass
prescriptions, as well as recordkeeping requirements.\84\ Other states
regulate less comprehensively. For example, some states require
opticians to dispense eyeglasses only upon the written prescription of
a prescriber,\85\ while other states allow more flexibility.\86\
Further, some states that require a prescription for the sale of
eyeglasses do not explicitly set forth specific components of an
eyeglass prescription.\87\ State regulatory frameworks also differ on
expiration dates for eyeglass prescriptions: some states require that
eyeglass prescriptions expire within a certain period; \88\ some states
mandate that prescriptions be valid for at least a certain amount of
time; \89\ other states leave that determination to the prescriber;
\90\ while still other states are silent on the issue.\91\
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\84\ See Alaska Stat. Ann. Sec. Sec. 48.310, 48.920; La. Admin.
Code tit. 46, Sec. LI-505.
\85\ See Ky. Rev. Stat. Ann. Sec. 320.300; N.Y. Comp. Codes R.
& Regs. tit. 18, Sec. 505.6.
\86\ Mass. Gen. Laws Ann. ch. 112, Sec. 73C (permitting
duplications, replacements, reproductions or repetitions at retail
without a prescription); N.C. Gen. Stat. Ann. Sec. 90-235 (same).
\87\ N.C. Gen. Stat. Ann. Sec. 90-236.1; Del. Code Ann. tit.
24, Sec. 2122.
\88\ DC Mun. Regs. tit. 17, Sec. 6416.1 (expiration of 1 year
after the issue date unless there is a medical reason that warrants
a prescription for less than 1 year.); Fla. Stat. Ann. Sec. 463.012
(eyeglass prescriptions shall be considered valid for a period of 5
years).
\89\ Cal. Bus. & Prof. Code Sec. 2541.1 (``The expiration date
of a spectacle lens prescription shall not be less than two to four
years from the date of issuance unless medical reason for earlier
reexamination''); Mich. Comp. Laws Ann. Sec. 333.5557 (setting
expiration date of no less than 1 year from the date of the
examination unless medical reason for shorter time).
\90\ 852 Ind. Admin. Code 1-5.1-1 (stating it is the
optometrist's responsibility to determine the expiration of the
prescription.); Kan. Admin. Regs. Sec. 65-8-4 (requiring prescriber
to include on the prescription the ``expiration date, if
appropriate'').
\91\ Ark. Code Ann. Sec. 17-90-108 (A)(3) (providing expiration
term for contact lens prescriptions, but not for eyeglass
prescriptions); Wis. Admin. Code Opt Sec. 5.02 (providing that a
contact lens prescription must contain the date of expiration, but
making no mention of the expiration of eyeglass prescriptions).
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II. Eyeglass Rule Review

A. Evidentiary Standard

The Commission promulgated the Eyeglass Rule under section 18 of
the FTC Act, which grants the Commission the authority to adopt rules
defining unfair or deceptive acts or practices in or affecting
commerce.\92\ When amending or repealing the Rule, the Commission must
follow the same section 18 procedures governing the adoption of
rules,\93\ and in doing so, engages in a multi-step inquiry. To make a
determination that a 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? \94\
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\92\ 15 U.S.C. 57a(a)(1)(B).
\93\ 15 U.S.C. 57a(d)(2)(B) which states a substantive amendment
to, or repeal of, a rule promulgated under subsection (a)(1)(B)
shall be prescribed, and subject to judicial review, in the same
manner as a rule prescribed under that subsection.
\94\ 15 U.S.C. 45(n); see also Eyeglass II Rule, 54 FR 10285,
10287; Letter from the FTC to Hon. Wendell Ford and Hon. John
Danforth, Committee on Commerce, Science and Transportation, United
States Senate, Commission Statement of Policy on the Scope of
Consumer Unfairness Jurisdiction (December 17, 1980), Appended to
International Harvester Co., 104 F.T.C. 949, 1070, 1073 (1984).
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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.'' \95\ The Commission can find prevalence where
information available to it indicates a widespread pattern of unfair or
deceptive acts or practices.\96\ Once the Commission finds that an
unfair act or practice is prevalent, it has wide latitude in fashioning
a remedy and need only show a ``reasonable relationship'' between the
unfair act or practice and the remedy.\97\
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\95\ 15 U.S.C. 57a(b)(3).
\96\ 15 U.S.C. 57a(b)(3)(B).
\97\ Am. Fin. Servs. Ass'n v. FTC, 767 F.2d 957, 988 (D.C. Cir.
1985) (quoting Jacob Siegel Co. v. FTC, 327 U.S. 608, 612-13
(1946)).
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In making this proposal, the Commission has relied on a record that
includes public comments received in response to the Commission's 2015
advance notice of proposed rulemaking (``ANPR'') that initiated this
rule review,\98\ and incorporates the rulemaking record for the 2020
amendments to the CLR to the extent that record provides information
pertinent to the prescription release provision of the Eyeglass
Rule.\99\ The

[[Page 254]]

Commission has also examined the state of the marketplace and the
content of consumer complaints about prescriber practices. Further, the
Commission remains cognizant of the lengthy history and record that
supported the enactment of the Eyeglass Rule and the CLR. Based on the
entire record for the Rule, the Commission has reason to believe that
prescribers' failure to automatically 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--remains prevalent,
and millions of Americans every year are not receiving their eyeglass
prescriptions as required by law. The Commission also believes that a
risk of 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. Further, the Commission believes that documentation of
prescription release is necessary to better effectuate compliance with,
as well as enforcement of, the Rule. Consequently, the Commission
proposes amending the Rule to implement a Confirmation of Prescription
Release requirement similar to that now required by the CLR.\100\
Pursuant to these amendments, prescribers would be required to do one
of the following:
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\98\ Ophthalmic Practice Rules (Eyeglass Rule), Advance Notice
of Proposed Rulemaking; Request for Comment, 80 FR 53274 (Sept. 3,
2015) [hereinafter Eyeglass Rule ANPR].
\99\ The 2020 Contact Lens Rulemaking record includes comments
to the CLR RFC; the CLR NPRM; the Public Workshop Examining Contact
Lens Marketplace and Analyzing Proposed Changes to the Contact Lens
Rule; Public Workshop and Request for Public Comment, 82 FR 57889
(Dec. 8, 2017) [hereinafter CLR WS]; and the CLR SNPRM. Public
comments received in response to these notices are available on
Regulations.gov.
https://www.regulations.gov/document/FTC-2015-0093-0001 (CLR RFC
Comments); https://www.regulations.gov/document/FTC-2016-0098-0001
(CLR NPRM Comments); https://www.regulations.gov/document/FTC-2017-0099-0001 (CLR WS Comments); and https://www.regulations.gov/document/FTC-2019-0041-0001 (CLR SNPRM Comments). Regulations.gov
has assigned each comment an identification number appearing after
the name of the commenter. This notice cites comments using the last
name of the individual submitter, or the name of the organization
and the individual within the organization who submitted the
comment, along with the comment identification number assigned by
Regulations.gov.
\100\ 16 CFR 315.3.
---------------------------------------------------------------------------

(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. The
Commission's proposal provides sample language for confirmation options
(i), (ii), and (iii), but also allows prescribers to craft their own
wording of the signed confirmation for these options if they so desire.
As with the CLR's Confirmation requirement, the proposed Confirmation
of Prescription Release requirement for eyeglass prescriptions would
apply only to prescribers with a direct or indirect financial interest
in the sale of eyeglasses.
The Commission believes that the proposed amendment will prevent
consumer harm, and that the proposed amendment is necessary to remedy
demonstrated failures of some providers to automatically release
prescriptions at the completion of an eye examination, and to ensure a
competitive marketplace for eyeglasses. The Commission notes that
providers who comply with the automatic release provision of the Rule
may face a competitive disadvantage because of the widespread non-
compliance of other providers. This creates an unlevel playing field
and undermines competition. The Commission is sensitive to any
additional burden or cost that this rule change imposes on business.
However, it believes that this proposal maximizes the benefits of
comparison-shopping with a relatively small burden or cost on business.
The potential benefit of increasing the number of patients in
possession of their eyeglass prescriptions is substantial: namely,
increased flexibility and choice for consumers; a reduced likelihood of
errors associated with incorrect, invalid, and expired prescriptions,
and consequently, improved patient safety; and an improved ability for
the Commission to enforce and monitor prescriber compliance with the
Rule's prescription release requirements.
The proposal would also align the prescription release related
provisions of the Rule with the CLR, thereby reducing confusion and
complexity that might arise for consumers and prescribers from having
different prescription release requirements for eyeglass and contact
lens prescriptions. In addition, because the CLR already obligates
ophthalmologists and optometrists to release contact lens
prescriptions, to obtain a confirmation, and to maintain records, the
marginal cost of the proposed amendment to the Eyeglass Rule would be
extremely low. Prescribers likely have forms and systems in place
already, which may need only minor adjustments to accommodate
confirmations for eyeglasses prescriptions.
The Commission also proposes permitting prescribers to comply with
automatic prescription release via electronic delivery in certain
circumstances.\101\ The Commission does not propose, at this time, to
implement other recommendations about which it requested comment in the
ANPR, including requiring prescribers to provide duplicate copies of
prescriptions to patients; to provide a copy of a prescription to, or
verify a prescription with, third-party sellers; or to add pupillary
distance to prescriptions.
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\101\ See Section IV.B.2.a, infra. The Commission also clarifies
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 under 16 CFR 456.2(a), a clarifying, technical rule
amendment. See Section IV.B.3, infra. The Commission further
clarifies that the term ``eye examination'' used in the Rule refers
to a refractive eye examination. See Section V.C, infra.
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B. Overview of Comments in Response to ANPR

In September 2015, as part of its routine review of Commission
rules and guides, the Commission published the ANPR seeking public
comment on, among other things: the continuing need for the Rule; the
Rule's economic impact and benefits; possible conflict between the Rule
and state, local, or other federal laws or regulations; and the effect
on the Rule of any technological, economic, or other industry changes.
The Commission also sought comment on the following specific questions:
should the definition of ``prescription'' be modified to include
pupillary distance; should the Rule be extended to require that
prescribers provide their patients with a duplicate copy of a
prescription; and should the Rule be extended to require that a
prescriber provide a copy to or verify a prescription with third
parties authorized by the patient? \102\
---------------------------------------------------------------------------

\102\ Eyeglass Rule ANPR, 80 FR 53274, 53276.
---------------------------------------------------------------------------

This notice of proposed rulemaking summarizes the comments received
in response to the ANPR and explains why the Commission continues to
believe that the Eyeglass Rule is necessary. It also explains why the
Commission is proposing certain amendments and why it declines to
propose others. Additionally, it seeks additional comment on certain
questions. Finally, the NPRM sets forth the Commission's regulatory
analyses under the Regulatory Flexibility and Paperwork Reduction Acts,
as well as the text of the proposed amendments.
The Commission received 868 comments in response to the ANPR from a
variety of individuals and entities, including ophthalmologists,
optometrists, opticians, trade associations, consumers (and
representatives of consumers), and eyeglass sellers.\103\ Virtually all
of the

[[Page 255]]

comments supported retaining the Rule. Some commenters, including trade
associations that represent opticians and retailers that employ
optometrists and opticians, stated that the Rule is needed because some
prescribers still are not automatically releasing prescriptions and
some consumers face resistance when they try to obtain their
prescriptions.\104\ The AOA, which represents approximately 33,000
doctors of optometry, questioned the continued need for the Rule based
on its understanding that doctors of optometry widely comply with the
Rule's requirements, but stated that the Rule--as currently drafted--is
not necessarily harmful.\105\
---------------------------------------------------------------------------

\103\ The comments are posted at https://www.regulations.gov/document/FTC-2015-0095-0001. This document cites comments from the
Eyeglass Rule ANPR using the comment number assigned by
Regulations.gov without the preceding identification ``FTC-2015-
0095.'' The citations also include: for comments submitted by
individuals, the last name of the commenter; and for comments
submitted on behalf of organizations, the name of the organization
and the last name of the individual submitting on behalf of the
organization. For instance, the full comment number assigned by
Regulations.gov to the comment submitted by an individual named
Publi is FTC-2015-0095-0040. In this document, that comment is cited
as ``Public (Comment #0040)''.
\104\ See, e.g., Opticians Association of Virginia (Comment
#0647 submitted by Nelms) (stating that patients are led into the
dispensary before paying for their exam and requesting the Rule be
amended to include language that the prescription be given to the
patient without additional sales pressure or intimidation); Burchell
(Comment #0866); NAOO (Comment #0748 submitted by Cutler);
Professional Opticians of Florida (Comment #0803 submitted by
Couch). Other commenters more generally stated their support for the
Rule. See Publi (Comment #0040); Santini (Comment #0047); Costa
(Comment #0068); Ellis (Comment #0189); Hildebrand (Comment #0220);
Prevent Blindness (Comment #0385 submitted by Parry); DiBlasio
(Comment #0441); Pulido (Comment #0019); Stuart (Comment #0841).
\105\ Comment #0849 submitted by Peele; see also Barnes (Comment
#0043) (stating she complies with the Rule although it is
unnecessary since any ethical doctor will release a non-expired
prescription to a patient); Kanevsky (Comment #0364) (optometrist
states she and the prescribers she knows comply with the Rule).
---------------------------------------------------------------------------

Warby Parker, a large online eyeglasses retailer,\106\ and a few
consumers indicated their belief that ordering eyeglasses online is a
good option as it provides consumers with an affordable and convenient
choice.\107\ Some indicated their support for Rule changes that would
permit online sales to occur with greater ease. Specifically, some
commenters supported requirements for prescribers to provide copies of
prescriptions to authorized third-party sellers upon a seller's request
and to provide duplicate copies of prescriptions to patients upon
request.\108\ Some commenters also suggested the Rule should require
prescribers to post a ``bill of rights'' or conspicuous signage of
consumers' rights to a copy of their prescription.\109\ Some commenters
also expressed support for adding a requirement that prescriptions
include pupillary distance--a measurement needed for consumers to order
eyeglasses online--and for the Rule to prohibit eyeglass prescriptions
from including any expiration dates, or at least unnecessarily short-
term expiration dates.\110\
---------------------------------------------------------------------------

\106\ Warby Parker, which began as an online-only entity but now
has over 100 brick and mortar locations in the U.S., began
operations in 2010 and appears to be the largest online eyeglass
seller. VisionMonday, ``Top 50 U.S. Optical Retailers 2020,''
available at https://www.visionmonday.com/vm-reports/article/key-optical-players-ranked-by-us-sales-in-2019/.
\107\ Thompson (Comment #0333); Berge (Comment #0352); Warby
Parker (Comment #0817 submitted by Kumar); see also Senate Majority
Leader Charles Schumer (Comment #0865).
\108\ See, e.g., DeMuth, Jr. (Comment #0055); Jozwik (Comment
#0002); Schwartz (Comment #0514); Opticians Association of Virginia
(Comment #0647 submitted by Nelms); Pulido (Comment #0019); Warby
Parker (Comment #0817 submitted by Kumar); see also NAOO (Comment
#0748 submitted by Cutler); Professional Opticians of Florida
(Comment #0803 submitted by Couch); Opternative (now Visibly)
(Comment #0853 submitted by Dallek).
\109\ Tedesco (Comment #0042) (signage); Warby Parker (Comment
#0817 submitted by Kumar) (bill of rights and signage).
\110\ See, e.g., Hildenbrand (Comment #0049) (expiration);
Fainzilberg (Comment #0051) (pupillary distance); Wintermute
(Comment #0067) (pupillary distance); Cordivari (Comment #0069)
(expiration); Dickens (Comment #0176) (pupillary distance); O'Dea
(Comment #0188) (pupillary distance); Nystrom (Comment #0254)
(expiration); Meszaros (Comment #0303) (expiration); Buntain
(Comment #0529) (expiration); Morel (Comment #0712) (expiration);
Warby Parker (Comment #0817 submitted by Kumar) (expiration and
pupillary distance).
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On the other hand, many prescribers felt the Commission should
limit, ban, or regulate the online sale of eyeglasses on grounds that
such sales are less safe because eyeglasses sold online do not always
adhere to prescription specifications and glass impact-resistance
requirements.\111\ Some prescribers commented that their offices are
burdened by the problematic practices of internet-based eyewear
companies, since the patient ultimately goes to their prescriber for a
remedy if they have an issue with their online eyeglass purchase.\112\
---------------------------------------------------------------------------

\111\ See, e.g., Pentecost (Comment #0626); Bolenbaker (Comment
#0633); McWilliams (Comment #0635); Cervantes (Comment #0671);
Harrison (Comment #0718); Nellis (Comment #0725); Ambler (Comment
#0025).
\112\ AOA (Comment #0849 submitted by Peele); Pentecost (Comment
#0626); McWilliams (Comment #0635); Nellis (Comment #0725); Diener
(Comment #0017). The AOA also stated its concern that some online
retailers may be using foreign manufacturers with questionable labor
standards. Comment #0849.
---------------------------------------------------------------------------

The AOA stated that the Rule should not require prescribers to
provide additional copies of prescriptions to consumers because
prescribers must be allowed to use their clinical judgment to determine
whether it is appropriate to provide additional copies after the eye
exam was performed.\113\ The organization also questioned the FTC's
authority to add a requirement to the Rule mandating that prescribers
respond to authorized third-party requests.\114\ The American Academy
of Ophthalmology (``AAO''), the largest national member association of
ophthalmologists, stated that it was unaware of any significant issues
with consumers receiving duplicate copies of their prescriptions from
ophthalmologists, noting that its members put significant time and
resources into ensuring patients receive prescriptions in a timely
manner and traditionally provide duplicates without charge.\115\
---------------------------------------------------------------------------

\113\ Comment #0849 submitted by Peele. The AOA also stated that
it is already common practice for prescribers to provide duplicate
copies of prescriptions upon request. Id.
\114\ Id.
\115\ Comment #0864 submitted by Haber.
---------------------------------------------------------------------------

Further, the AOA, the AAO, and individual prescribers commented
that the Rule should not require that a prescription include pupillary
distance, because, among other reasons, they believe this measurement
is part of the dispensing of eyeglasses, and not part of a refractive
examination.\116\ Prescribers also generally did not support having an
expiration date of more than one year for eyeglasses, or requested that
the FTC defer to state law and the medical judgment of prescribers to
determine if and when a prescription should expire.\117\
---------------------------------------------------------------------------

\116\ See, e.g., AAO (Comment #0864 submitted by Haber); AOA
(Comment #0849 submitted by Peele); Johnson (Comment #0654); Nichols
(Comment #0461); Patterson (Comment #0469); Chung (Comment #0474);
Wareham (Comment #0498); Yuhas (Comment #0505); Mangano (Comment
#0525); Hopkins (Comment #0776); Alvarez (Comment #0838).
\117\ See, e.g., AAO (Comment #0864 submitted by Haber); AOA
(Comment #0849 submitted by Peele).
---------------------------------------------------------------------------

A number of optician groups commented that the Rule should require
that eyeglass dispensers only sell eyeglasses after obtaining a copy of
a prescription, or verifying a prescription with the prescriber, to
ensure the safety of their patients.\118\ They also largely did not
want the Rule to require that

[[Page 256]]

prescriptions include pupillary distance because they prefer to take
this measurement and not be required to follow a measurement taken by
the prescriber.\119\ In addition, although many opticians stated a
preference for a one-year expiration date, they did not object to a
two-year expiration period unless a medical reason exists for requiring
a shorter period of time.\120\
---------------------------------------------------------------------------

\118\ See, e.g., Opticians Association of America (Comment #0638
submitted by Allen); Opticians Association of Kentucky (Comment
#0640 submitted by Castle); Opticians Association of Vermont
(Comment #0641 submitted by Williams); Opticians Alliance of New
York (Comment #0642 submitted by Cullen); Opticians Association of
Ohio (Comment #0683 submitted by Glasper); Opticians Association of
Iowa (Comment #0646 submitted by Dalton); South Carolina Association
of Opticians (Comment #0822 submitted by Harbert).
\119\ Id.
\120\ Id.
---------------------------------------------------------------------------

III. Requirements for Eyeglass Sellers

Although the Eyeglass Rule imposes certain requirements and
limitations on prescribers--namely that they automatically release
eyeglass prescriptions and do not charge fees or demand liability
waivers for doing so--the Rule does not otherwise regulate the sale of
eyeglasses. In this respect, the Eyeglass Rule diverges from the
Contact Lens Rule. For example, among other things, the CLR provides
that a dispenser may only sell contact lenses in accordance with a
valid prescription that is either presented to the seller or verified
by the prescriber.\121\ The CLR is based on the language Congress set
forth in the FCLCA, 15 U.S.C. 7603, whereas the Eyeglass Rule is more
narrowly tailored and does not regulate the terms of sale for
eyeglasses. The Commission's September 3, 2015 ANPR did not
specifically request comment on this issue. However, in response to the
Commission's request for feedback on general issues, including its
request for modifications to the Rule that may increase benefits to
consumers, some commenters offered their views on this topic, with many
opining that the FTC should more closely regulate eyeglass sales.
---------------------------------------------------------------------------

\121\ See 16 CFR 315.5(a).
---------------------------------------------------------------------------

In particular, the Opticians Association of America, a national
organization of opticians with over 10,000 members, commented that to
ensure patient safety, the Commission should mandate that all sellers
only sell eyeglasses after obtaining a copy of the prescription, or
after verifying the prescription information with a prescriber.\122\
---------------------------------------------------------------------------

\122\ Comment #0638 submitted by Allen; see also Opticians
Association of Kentucky (Comment #0640 submitted by Castle);
Opticians Association of Vermont (Comment #0641 submitted by
Williams); Opticians Alliance of New York (Comment #0642 submitted
by Cullen); Duff (Comment #0653); Opticians Association of Ohio
(Comment #0683 submitted by Glasper); Parent (Comment #0693);
Groenke (Comment #0697); Kline (Comment #0710); Schrup (Comment
#0765); Kuhl (Comment #0766); Gorsuch (Comment #0773); Frein
(Comment #0774); Hopkins (Comment #0776); Feldman (Comment #0780);
Anderson (Comment #0781); Lyden (Comment #0792); Jackson (Comment
#0707); Meinke (Comment #0795); Lorenczi (Comment #0796); Keas
(Comment #0798); Burkhart (Comment #0805); Albee (Comment #0806);
Rivera (Comment #0809); Warden (Comment #0820); Anderson (Comment
#0714); South Carolina Association of Opticians (Comment #0822
submitted by Harbert); Sansbury (Comment #0825); Williamson (Comment
#0827); Ardis (Comment #0830); Folline Vision Centers (Comment
#0837); Rump (Comment #0843); Murtha (Comment #0844); Heaton
(Comment #0845); Gage-Halman (Comment #0846); Malonjao (Comment
#0856); Jozwik (Comment #0002) (commenting that verification
minimizes mistakes since the information is straight from the
prescriber).
---------------------------------------------------------------------------

Some commenters also stated that eyeglasses sold online are
inferior in quality, or may come with an incorrect prescription.\123\
The Opticians Association of Alaska, Inc., for example, commented that
much of the eyewear sold online ``does not meet national tolerance
standards,'' and asserted that consumers often rely on brick and mortar
dispensaries to remedy problems stemming from poorly manufactured
eyeglass products purchased online.\124\
---------------------------------------------------------------------------

\123\ See, e.g., Strahl (Comment #372); Senate Majority Leader
Charles Schumer (Comment #0865); Pentecost (Comment #0626); Harrison
(Comment #0718); Nellis (Comment #0725).
\124\ Comment #0852 submitted by Brand.
---------------------------------------------------------------------------

The Opticians Association of America and others commented that
consumers' eye health may be negatively affected by unrestricted sales
practices, and called the lack of required verification for sellers a
``loophole'' in the Rule.\125\ Other commenters proposed that,
regardless of whether a prescription is presented or verified, the
online sale of eyeglasses should be limited or even banned
altogether.\126\
---------------------------------------------------------------------------

\125\ Opticians Association of America (Comment #0638 submitted
by Allen); Opticians Association of Kentucky (Comment #0640
submitted by Castle); Opticians Association of Vermont (Comment
#0641 submitted by Williams); Opticians Alliance of New York
(Comment #0642 submitted by Cullen); Opticians Association of Ohio
(Comment #0683 submitted by Glasper); South Carolina Association of
Opticians (Comment #0822 submitted by Harbert).
\126\ See, e.g., Opticians Association of Alaska, Inc. (Comment
#0852 submitted by Brand); Kline (Comment #0710).
---------------------------------------------------------------------------

However, commenters submitted very little empirical evidence of
consumer harm that would support restrictions on sales practices. The
only data referenced or submitted in support of additional Commission
regulation of eyeglass sales was a 2010 study focusing solely on the
online sale of eyeglasses. That study, conducted by Dr. Karl Citek
\127\ and others, found that many eyeglasses sold by online retailers
did not pass ANSI (American National Standards Institute) standards for
prescription accuracy or safety.\128\ In the study, ten individuals
(consisting of the researchers and their colleagues and associates)
ordered two pairs of eyeglasses apiece from ten online sellers.\129\
The published report does not identify the sellers used, stating only
that they were online eyeglass sellers with the ten highest page
rankings (most visited) at the time.\130\ According to the report, the
eyeglasses purchased, and subsequently received in the mail, were then
tested by an individual--described in the study as a researcher \131\--
for prescription accuracy, and tested by an independent laboratory for
impact-resistance.\132\ The study found that of the eyeglasses
purchased online, 28.6 percent contained at least one lens that failed
at least one parameter of optical analysis,\133\ and 22.1 percent had
at least one lens that failed impact testing at the lab.\134\
---------------------------------------------------------------------------

\127\ Dr. Citek is an optometrist and university professor. See
https://www.pacificu.edu/about/directory/people/karl-citek-ms-od-Ph.D.-faao.
\128\ Karl Citek et al., ``Safety and compliance of prescription
spectacles ordered by the public via the internet,'' Optometry, 82
(2011) 549-55.
\129\ Id. at 550.
\130\ Id.
\131\ Id. The study does not identify the researcher except by
the initials ``DLT,'' which correspond to one of the article's
authors, Daniel L. Torgersen. At the time, Torgersen was Vice
President of Management Information Systems and Special Projects for
the Walman Optical Company, an ophthalmic products provider, and
technical director of the Optical Laboratories Association. Id. at
549; see also, VisionMonday, OLA Announces 2009 Directors' Choice
Recipient and Awards of Excellence Final Nominees (Oct. 2009),
available at https://www.visionmonday.com/latest-news/article/ola-announces-2009-directors-choice-recipient-and-awards-of-excellence-final-nominees-16057/?msclkid=740f9983c64b11ec8e35481006e0819a a.
\132\ Citek, supra note 128, at 550. The independent laboratory
is not identified.
\133\ The parameters analyzed included sphere power, cylinder
power, cylinder axis, and horizontal prism imbalance. Id. at 552.
\134\ Id. at 554.
---------------------------------------------------------------------------

The Commission has reviewed the Citek study and has significant
reservations about the study's conclusion that eyeglasses purchased
online might not be ``of equal performance, value, or safety'' as those
dispensed in person.\135\ Significant weaknesses in the study's design
and reporting limit its usefulness. For example, the study does not
name the individual online retailers from whom lenses were purchased,
nor provide results for each retailer in the study. Hence, even for the
ten retailers in question, it is not possible to determine whether the
28.6 percent and 22.1 percent average failure rates reported are
typical failure rates or are skewed due to significantly higher
failures among a small number of relatively poorly performing actors.
In addition, the study does not report how click-rates correspond to
sales in the online market. Hence, it is unclear whether those online
retailers were also the ten leading online retailers in terms of sales

[[Page 257]]

(either in dollars or pairs of eyeglasses), whether they accounted for
any particular percentage of online eyeglass sales overall, or whether
they were, by some measure, representative of online sellers generally.
---------------------------------------------------------------------------

\135\ Id. at 555.
---------------------------------------------------------------------------

It is also unclear whether the Citek study's reported failure rate
for online sellers is any different from that for eyeglasses purchased
from traditional optical dispensaries. The study did not include
eyeglasses purchased directly from prescribers or brick and mortar
dispensaries.\136\ The study does note, however, that, according to a
previous study published in 1978, approximately 25 percent of eyewear
manufactured for traditional dispensaries fail at least one parameter
of optical analysis, a rate comparable to the online failure rate cited
in the Citek study.\137\
---------------------------------------------------------------------------

\136\ While none of the commenters submitted or referenced any
additional studies evaluating eyeglass sales practices, the
Commission is aware of a 2016 study from the United Kingdom
analyzing the acceptability, quality, and accuracy of glasses
purchased online and from optometry practices. Alison J. Alderson et
al., ``A Comparison of Spectacles Purchased Online and in UK
Optometry Practice,'' Optometry and Vision Science, 93 (2016) 1196-
1202. The study involved 33 eyeglass wearers who purchased 154 pairs
of eyeglasses online and 155 pairs in person from optometry
practices in the United Kingdom. Eyeglasses were evaluated based on
participant-reported preference, acceptability, and safety; an
assessment of lens, frame and fit quality; and the accuracy of
prescriptions to an international standard. Compared to the practice
eyeglasses, participants rated more of the online eyeglasses
unacceptable or unsafe due to poor fit, poor cosmetic appearance, or
inaccurate optical centration distance. While participants preferred
eyeglasses purchased from optometry practices to those purchased
online, lens quality and prescription accuracy were similar between
the two groups. Frame quality differed based on price, and the
authors noted that the online frames were significantly less
expensive and thus lower quality. The study authors noted areas for
potential improvement in sales practices both for online sellers and
optometry practices.
This study is informative of the types of problems eyeglass
wearers can encounter in an online or in person purchase and the
preferences that may motivate consumers when choosing where to
purchases eyeglasses, but the Commission does not believe it
provides an adequate basis for imposing further regulatory
requirements on eyeglass sellers. The study took place in the United
Kingdom, rather than the United States, and online retailers were
limited to those with a base in the United Kingdom, so the results
are not necessarily applicable to the US market. The study had
design limitations similar to the Citek study, such as not
identifying the online retailers (or, in this case, the optometry
practices), or providing the results for each retailer. Study
authors selected online retailers based on search engine results,
rather than sales volume, while study participants selected their
own optometry practices within a limited set of restrictions. In
addition, 97% of study participants had previously purchased their
eyeglasses from optometry practices (and may have chosen to purchase
from those same practices as part of the study), which might have
led to confirmation bias in the self-reported assessments. Moreover,
the study findings did not support a meaningful difference in the
quality or accuracy of glasses purchased online as compared to those
purchased in person.
\137\ See Citek, supra note 128, at 554 (citing G.A. Chase &
B.E. Lynch, ``An Examination of Ophthalmic Prescription Spectacle
Quality Relative to the American National Standard Z80.1-1972,''
Optical Index 1978; 53: 17-52). According to Citek, a subsequent
unpublished study found that most of these failures are caught
during secondary inspections before the eyeglasses leave the lab for
the dispensary. Id. at 554. Because the testing in each of the three
studies discussed herein was performed by different researchers in
different settings in different decades, it is impossible to know if
they were performing the same exact tests in the same exact manner,
so comparisons between the Citek study and the other two studies are
likely of questionable value.
---------------------------------------------------------------------------

In addition, the Citek study is a decade old, and was conducted
when the online sale of eyeglasses was in its relative infancy. The
eyeglass market has changed considerably since 2010, and it is probable
that online sales have changed in various ways: new sellers have
entered the market, seller market shares have probably shifted (as well
as relative page visits and click-through rates), and online vendors
from 2010 who are still operating may have modified their business
practices. Because of these and other concerns about the study, the
Commission cannot accord it significant weight.
Even if the Citek study were more compelling, however, it is
unlikely it would provide, by itself, sufficient justification for
adding new regulatory requirements to the Rule. The evidentiary record
as a whole does not contain sufficient empirical evidence establishing
that current eyeglass sales practices, whether by online vendors or
competing brick and mortar establishments, are harmful to consumers
and, therefore, should be banned or otherwise restricted. If the
Commission had evidence of significant harm associated with one
distribution channel in particular, it would need to assess whether new
regulatory restrictions would ameliorate those harms in a way that
would provide a net benefit to consumers. Furthermore, the Commission
notes that certain states expressly permit sellers to duplicate
eyeglasses, or do not require written prescriptions to make
eyeglasses,\138\ and a Commission regulation requiring presentation of
a prescription or verification of a prescription would have to preempt
these state laws. The Commission declines to take such action without
more compelling empirical evidence of consumer harm or benefits.
---------------------------------------------------------------------------

\138\ See, e.g., Mass. Gen. Laws ch. 112, Sec. 73C
(duplication, replacements, reproductions, or repetitions may be
done at retail without prescription); S.C. Code Ann. Sec. 40-38-280
(duplications, replacements, reproductions, or repetitions may be
provided without prescription).
---------------------------------------------------------------------------

IV. Section 456.2--Separation of Examination and Dispensing

A. Automatic Prescription Release

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 the eye
examination is completed. This provision provides, 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.\139\ Sections 456.2(b) and 456.2(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.
---------------------------------------------------------------------------

\139\ 16 CFR 456.2(a).
---------------------------------------------------------------------------

These provisions, typically referred to as the automatic
prescription release requirement (also sometimes referred to
historically as the required''separation of examination and
dispensing''),\140\ were intended to ensure that consumers have
``unconditional access'' to their ophthalmic prescriptions so they are
able to ``price shop'' for eyeglasses.\141\ As noted in the Eyeglass I
Report, without the ability to unconditionally obtain their
prescriptions, consumers lack available information to choose the
mixture of quality and price that best satisfies their needs.\142\
---------------------------------------------------------------------------

\140\ 16 CFR 456.2; see also Presiding Officer's Report, supra
note 33, at 17-24, 206.
\141\ Eyeglass I Rule, 43 FR 23992, 23992.
\142\ Eyeglass I Report, supra note 6, at 265 (citing hearing
testimony from the then-Commissioner of the New York City Department
of Consumer Affairs).
---------------------------------------------------------------------------

5. Comments on Whether To Retain Automatic Prescription Release
In response to a request for comments on the continuing need for
the automatic prescription release provision,\143\ many commenters--
including opticians, optometrists, ophthalmologists, eyeglass sellers,
and consumers--expressed strong support.

[[Page 258]]

Several stated that the provision benefits consumers by fostering
comparison-shopping and competition.\144\ As one consumer commented,
``[o]btaining a prescription for my eyeglasses has been crucial,
improving my ability to purchase glasses at fair prices.'' \145\
Another declared that the Rule ``has provided consumers the benefit of
choosing where they'd prefer to buy their eyeglasses, saving them money
on that expense.'' \146\
---------------------------------------------------------------------------

\143\ Eyeglass Rule ANPR, 80 FR 53274, 53275.
\144\ See, e.g., Publi (Comment #0040); Ellis (Comment #0189);
Prevent Blindness (Comment #0385 submitted by Parry); DiBlasio
(Comment #0441); Kelley (Comment #0804); Opternative (now Visibly)
(Comment #0853 submitted by Dallek).
\145\ Varazo (Comment #0250).
\146\ Pulido (Comment #0019); see also Shuval (Comment #0564)
(``The [E]yeglass [R]ule is a beautiful and wonderful thing. Giving
patients a copy of their prescription is essential.'').
---------------------------------------------------------------------------

Other commenters stressed a continuing need for this provision in
the Rule, with some contending that the need is as great or greater now
as when the Rule was first implemented. According to one comment
(submitted on behalf of three individuals), the advent of online
optical dispensaries can put more pressure on prescriber profits,
making it even more vital to mandate automatic release in order to
ensure that prescribers do not try to recoup lost profits by coercing
patients to buy eyewear in-house.\147\ According to this comment, the
automatic release provision compels prescribers to remain competitive,
leading to lower prices and higher quality eyeglasses.\148\ Another
commenter, the Professional Opticians of Florida, stated that since the
Rule was first implemented, there has been a ``dramatic increase'' in
prescribers' offices with attached optical dispensaries, increasing the
potential for such prescribers to steer patients into purchasing
eyeglasses in-house.\149\
---------------------------------------------------------------------------

\147\ Burchell (Comment #0866). The FTC recognizes that the
increase in online optical dispensaries may theoretically lead to
reduced prescriber profits, but notes that the evidentiary record
does not currently contain empirical evidence demonstrating this
effect.
\148\ Id.
\149\ Comment #0803 submitted by Couch.
---------------------------------------------------------------------------

Opticians, in particular, expressed strong support for the
automatic prescription release requirement, with the National
Association of Optometrists and Opticians (``NAOO''), a trade
association representing co-located optical dispensaries,
characterizing the Rule as a ``triumph of narrowly tailored government
action that directly addresses [a] specific consumer problem with
minimal cost and remarkable benefits.'' \150\ According to NAOO, any
costs to prescribers from prescription release has been ``trivial,''
while benefits to consumers have been significant, allowing them to
comparison-shop and choose the optical dispenser of their choice.\151\
This, in turn, according to the commenter, has helped foster
exponential growth in the ophthalmic goods market.\152\ NAOO added that
it was critical to maintain the automatic release requirement due to
the continuing ``imbalance of power between patient and prescriber,''
and powerful financial incentives for prescribers--who sell the
products that they prescribe--to keep sales in-house.\153\
---------------------------------------------------------------------------

\150\ Comment #0748 submitted by Cutler; see also, e.g., Ahrens
(Comment #0022) (other opticians expressing support for automatic
prescription release); Opticians Association of Alaska, Inc.
(Comment #0852 submitted by Brand); Hoffman (Comment #0026).
\151\ Comment #0748 submitted by Cutler. The NAOO noted that
based on member experience and observation, thousands of
optometrists affiliated in co-location with their members comply
with the Rule with ``little or no added costs or other burden on the
eye care practice.'' Id.
\152\ Id.
\153\ Id. NAOO noted that optometry and ophthalmology are among
the very few health care professions in which prescribers also sell,
and often derive a significant portion of their income from, the
products they prescribe. Id.; see also note 66, supra (product sales
typically account for 55 to 65 percent of optometrist revenue). In
commenting on the CLR, however, the AOA pointed out that health care
professionals in other areas--such as ambulatory surgery centers,
orthopedic centers, and dental service providers, among others, also
sell what they prescribe or recommend for treatment. AOA (CLR SNPRM
Comment FTC-2019-0041-0096). The Commission acknowledged this fact.
CLR Final Rule, 85 FR 50668, 50679-80 (stating that the Commission
did not base its CLR amendments solely on a belief that contact lens
prescribers' role and market is necessarily unique, but rather
considered the structure of the market as a contributing factor in
an overall evaluation of the need for improved compliance and
enforcement).
---------------------------------------------------------------------------

On the other hand, the AOA commented that, ``[i]t is our
understanding that doctors of optometry widely comply with the Rule,''
and did not believe that compliance with the prescription release
provision remains an issue.\154\ The AOA also stated that patients are
well informed of their ability to obtain their eyeglass prescriptions
and have a greater expectation to receive their health information from
their doctors as a result of the Health Insurance Portability and
Accountability Act of 1996 (``HIPAA'').\155\ Accordingly, the AOA
posited that ``[g]iven that the requirements outlined in the Rule are
now standard practice, it is questionable as to whether the Rule serves
a continued benefit to patients.'' \156\ Nonetheless, the AOA did not
expressly suggest modifying or terminating the prescription release
provision, stating that the Rule, as currently drafted, is not
necessarily harmful.\157\ In addition, a few individual optometrists
concurred that patients should be given their prescriptions after a
refraction examination.\158\
---------------------------------------------------------------------------

\154\ Comment #0849 Submitted by Peele.
\155\ Public Law 104-191 (Aug. 21, 1996); Comment #0849
submitted by Peele.
\156\ Comment #0849 submitted by Peele.
\157\ Id.
\158\ See, e.g., Kim (Comment #0667); Heuer (Comment #0670).
---------------------------------------------------------------------------

None of the commenters expressly proposed eliminating the
prescription release requirement. Some prescribers, however, commented
that requiring automatic release is unnecessarily burdensome and
wasteful, since not all patients want paper copies of their
prescription.\159\ As one prescriber explained, ``A lot of patients
don't want the copy and we end up throwing the paper away. I sometimes
worry that if a patient chose not to take it, we would later be accused
of not offering it to them.'' \160\ Some commenters suggested that
instead of automatically providing a copy, the Rule should require that
prescriptions be made accessible electronically, or only upon
request.\161\
---------------------------------------------------------------------------

\159\ Barnes (Comment #0043); Lunsford (Comment #0346).
\160\ Barnes (Comment #0043).
\161\ Lunsford (Comment #0346); B.C. (Comment #0749).
---------------------------------------------------------------------------

6. Compliance With the Automatic Prescription Release Requirement
Commenters disagreed over whether most prescribers comply with the
automatic prescription release requirement. As stated above, the AOA
expressed its belief that doctors of optometry typically comply with
the Rule.\162\ In addition, several individual prescribers asserted
that they always give patients a paper copy of their prescription.\163\
Other individual prescribers commented that all the prescribers they
know do the same.\164\ It

[[Page 259]]

should be noted, however, that prescribers may be aware in a general
way of their obligation to release prescriptions and yet be ignorant of
the precise requirements of the prescription release provision. For
example, in some instances, prescribers may violate the Rule by waiting
for a patient to ask for the prescription, or asking a patient, ``Do
you want a copy of your prescription?'' In both circumstances, the
prescriber has violated the Rule since the prescription is not
automatically provided. Indeed, a number of prescribers admitted to
doing exactly that when commenting on the CLR, with many misstating the
prescription release requirements and asserting that they always
``offer'' prescriptions to their patients or provide them ``when
requested,'' rather than automatically providing prescriptions
``whether or not requested by the patient,'' as required under both the
Contact Lens Rule and Eyeglass Rule.\165\ Many prescribers may thus
believe they are complying with the Rule even though they are not, and
might also be incorrect in assessing, and reporting on, their own
compliance and that of their colleagues.
---------------------------------------------------------------------------

\162\ Comment #0849 submitted by Peele.
\163\ Johnson (Comment #0654); Michel (Comment #0472); Cook
(Comment #0541); Kaulfuss (Comment #0570); McWilliams (Comment
#0635); Brosman (Comment #0637). Numerous prescribers who commented
on the Contact Lens Rule proposals also wrote that they consistently
release prescriptions to patients after each eye examination--
including examinations for eyeglass prescriptions--and attested that
their colleagues do the same. E.g., Carlson (CLR WS Comment FTC-
2017-0099-0727) (``Each and every patient of mine gets their glasses
and contact lens prescription at the end of their exam. It is not
only the law but ethical.''); Chakuroff (CLR WS FTC-2017-0099-0763)
(``Every patient I see is provided a copy of their glasses and
contact lens prescriptions.'').
\164\ Kanevsky (Comment #0364); Smith (Comment #0365);
Hartenstein (CLR WS FTC-2017-0099-0766) (``The overwhelming majority
of eye doctors already provide patients with copies of prescriptions
for both glasses and contact lenses per your previous mandates.'');
see also CLR SNPRM, 84 FR 24664, 24673.
\165\ See CLR SNPRM, 84 FR 24664, 24673-74. Staff is aware of
similar prescriber comments in the context of eyeglass
prescriptions. The Eyeglass Rule specifically mandates that patients
be handed a copy of their prescriptions automatically without their
asking for them. And while seemingly minor, the act of waiting for a
patient to ask, or offering a prescription rather than automatically
providing it, can put patients in an awkward position, since they
may feel they are showing disloyalty to their prescriber if they
want to shop for eyeglasses elsewhere. See Eyeglass II Report, supra
note 26, at 271 (noting that according to commenters, consumers are
not always comfortable requesting their prescription, and may be
unwilling to risk offending their doctors). Such an act may
therefore undermine the Rule's intent to boost comparison-shopping
and foster a vibrant marketplace.
---------------------------------------------------------------------------

A number of commenters, meanwhile, asserted that, even though the
Rule has required, for more than four decades, that prescribers
automatically release eyeglass prescriptions to their patients,
prescribers still routinely fail to comply, either by failing to
provide a prescription unless requested, requiring a waiver in exchange
for a prescription, or failing to provide a prescription at all.
According to eyeglass seller and manufacturer Warby Parker, ``[i]t is
well known in the industry that many [prescribers] refuse to give
patients prescriptions unless they specifically request it, and some
[prescribers] place intimidating and unnecessary warnings or waivers of
responsibility on the prescriptions they do release.'' \166\
---------------------------------------------------------------------------

\166\ Comment #0817 submitted by Kumar.
---------------------------------------------------------------------------

One commenter, an optician, opined that the practice of prescribers
failing to automatically release prescriptions is ``flagrant,'' \167\
while another commented that ``[i]t has been my observance that the
Eyeglass Rule is not being complied with at all.'' \168\ These two
commenters asserted that prescribers often do not provide patients with
prescriptions until after patients are led into the prescriber's in-
house optical dispensary,\169\ a practice that would violate the Rule
because the examination has concluded, and the patient should have
already been provided with the prescription. And the NAOO commented
that while it did not possess empirical evidence, ``experiential and
anecdotal evidence and observation of industry leaders indicates that
while many consumers are getting a copy of their eyeglass prescription
upon completion of the eye exam, some are not, and some are faced with
resistance when they attempt to obtain their prescriptions.'' \170\
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\167\ Santini (Comment #0047) (``In my area, it is common for
eye care providers who exam [sic] AND Sell glasses to not be
forthcoming with providing the spectacle Rx, particularly when
consumers demand it'').
\168\ Tedesco (Comment #0042).
\169\ Id.; Santini (Comment #0047); see also Opticians
Association of Virginia (Comment #0647 submitted by Nelms).
\170\ Comment #0748 submitted by Cutler.
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The Commission did not receive many comments from consumers
specifically addressing the issue of prescription release in response
to the ANPR. However, a number of consumers who commented during the
CLR review stated that their prescribers failed to provide them with
their prescriptions for contact lenses and for eyeglasses.\171\ And
separate from these rule review processes, the Commission continues to
receive consumer complaints about noncompliance with the automatic
release provisions of both the Eyeglass Rule and Contact Lens Rule. In
December 2020, the Commission sent warning letters to 28 prescribers
after consumers complained to the FTC that the prescribers had violated
the Eyeglass Rule.\172\ And in April 2016, the Commission sent warning
letters to 45 contact lens prescribers after receiving complaints
alleging the prescribers had violated the CLR by failing to release
prescriptions.\173\
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\171\ See, e.g., Nichols (CLR WS Comment FTC-2017-0099-0209)
(said she was charged for her eyeglass prescription); Tennison (CLR
WS Comment FTC-2017-0099-0453) (does not receive written
prescriptions for lenses or eye glasses after exams); Bogner (CLR
NPRM Comment FTC-2016-0098-1398); Rasczyk (CLR NPRM Comment FTC
2016-0098-1415); Strobel (CLR NPRM Comment FTC-2016-0098-1446);
Austin (CLR NPRM Comment FTC-2016-0098-1514); Martinez (CLR NPRM
Comment FTC-2016-0098-2090). A few other CLR consumer commenters,
however, stated that although they do not receive their
prescriptions after a contact lens fitting, they typically do
receive them after a refraction exam for eyeglasses. See, e.g., Hall
(CLR WS Comment FTC-2017-0099-0227); Krainman (CLR NPRM Comment FTC-
2016-0098-1373); Zeledon (CLR NPRM Comment FTC-2016-0098-1377).
\172\ Press Release, Fed. Tr. Comm'n, FTC Sends 28 Warning
Letters Regarding Agency's Eyeglass Rule (December 8, 2020), https://www.ftc.gov/news-events/press-releases/2020/12/ftc-sends-28-warning-letters-regarding-agencys-eyeglass-rule. Similarly, in May
2016, the Commission sent warning letters to 38 prescribers after
receiving consumer complaints alleging violations of the Eyeglass
Rule. Press Release, Fed. Tr. Comm'n, FTC Issues Warning Letters
Regarding Agency's Eyeglass Rule (May 13, 2016), https://www.ftc.gov/news-events/press-releases/2016/05/ftc-issues-warning-letters-regarding-agencys-eyeglasses-rule.
\173\ Press Release, Fed. Tr. Comm'n, FTC Issues Warning Letters
Regarding the Agency's Contact Lens Rule (Apr. 7, 2016), https://www.ftc.gov/news-events/press-releases/2016/04/ftc-issues-warning-letters-regarding-agencys-contact-lens-rule. During the Commission's
CLR review, the AOA and several optometrists pointed out that based
on a percentage of the total number of eye patients in the United
States, the number of complaints to the FTC about prescribers'
failure to release prescriptions is quite small. See CLR Final Rule,
85 FR 50668, 50676; CLR SNPRM, 84 FR 24664, 24674. This is correct,
but does not mean that the number of prescribers who fail to release
prescriptions is correspondingly small. As discussed in some detail
in the CLR SNPRM and CLR Final Rule, a lack of formal consumer
complaints about failure to release prescriptions does not equate
with prescriber compliance. Based on the Commission's experience,
the vast majority of injured or impacted consumers do not typically
register complaints with the government, and even fewer are likely
to file a formal complaint about a prescriber's failure to release
their prescription. See CLR Final Rule, 85 FR 50668, 50676; CLR
SNPRM, 84 FR 24664, 24674-75.
---------------------------------------------------------------------------

Two commenters also submitted consumer survey evidence about
prescriber compliance. Warby Parker submitted results from an October
2015 survey, conducted on the company's behalf by the polling firm
SurveyMonkey, which reported that, of consumers who had purchased
eyeglasses within the last three years, 47 percent of those who saw
optometrists and 31 percent of those who visited ophthalmologists were
not automatically provided with a physical copy of their eyeglass
prescription.\174\
---------------------------------------------------------------------------

\174\ Comment #0817 submitted by Kumar. The SurveyMonkey survey
comprised 1,329 respondents recruited from a sample that was U.S.
Census-balanced and representative of the national distribution of
major demographic factors, including age, gender, geography, and
income. Respondents were not informed of the identity of the survey
sponsor. Survey respondents who had purchased eyeglasses within the
last three years (65% of the total respondents) answered questions
about prescription information, purchase behavior, and prescriber
experience. Within the set of respondents who had purchased within
the last three years, 54% had purchased within the last 12 months.
There were no significant differences in responses regarding
automatic prescription release between those who had purchased
within the last year and those who had purchased between one and
three years prior to the survey. The significant difference in
automatic release compliance between optometrists and
ophthalmologists may be due to the fact that fewer ophthalmologists
sell eyeglasses, and might thus have less incentive to withhold a
consumer's prescription, but the survey did not directly explore
this issue.

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[[Page 260]]

Another commenter, contact lens seller 1-800 CONTACTS, cited a
survey--conducted on its behalf by the firm Survey Sampling
International (``SSI'') and submitted previously with a comment on the
Commission's Contact Lens Rule review--which found that only 34 percent
of eyeglass wearers automatically received their prescriptions on the
day of their office visit, with another 19 percent receiving it during
their visit, but only after asking for it.\175\ 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 percent
of consumers never received their prescription at all.\176\
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\175\ Comment #0834 submitted by Williams. According to 1-800
CONTACTS, the data derive from an October 2015 SSI online survey of
303 prescription eyeglass wearers. See ``FCLCA Study, Focus on
Prescription (Rx),'' attached as Exhibit B to 1-800 CONTACTS (CLR
RFC Comment FTC-2015-0093-0555 submitted by Williams). Respondents
were not informed of the identity of the survey sponsor. The
Commission has some concerns about the methodology utilized for this
survey, particularly about the lack of an ``I don't know'' response
option for some questions, but believes the information may still be
suggestive, particularly when viewed in conjunction with information
from other sources and the absence of contradictory data.
\176\ Id.
---------------------------------------------------------------------------

The Commission has also reviewed five consumer surveys--submitted
and considered during the CLR review--which found that between 21 and
34 percent of contact lens users did not receive their prescriptions
after their exam and fitting.\177\ These surveys asked only about
receipt of contact lens prescriptions, not eyeglass prescriptions, and
there are some differences in the examination and prescription
processes.\178\ But the mandatory prescription release requirements are
similar, and there is little evidence in the record to indicate that
prescribers provide eyeglass prescriptions in significantly greater
numbers than they do contact lens prescriptions.\179\
---------------------------------------------------------------------------

\177\ The results from the individual consumer surveys are as
follows: (1) June 2019 survey by Dynata on behalf of 1-800 CONTACTS
of 1,011 contact lens users found that 21% said they never received
their prescriptions (1-800 CONTACTS (CLR SNPRM Comment FTC-2019-
0041-0135)); (2) January 2017 survey by Caravan ORC International on
behalf of Consumer Action of 2,018 adults found that 31% of contact
lens users said that at their last eye exam, their doctor did not
provide them with a paper copy of their prescription (Consumer
Action (CLR NPRM Comment FTC-2016-0098-2954)); (3) December 2016
survey of 1,000 contact lens users by SSI on behalf of 1-800
CONTACTS found that 24% of consumer respondents said they did not
receive their prescription (1-800 CONTACTS (CLR NPRM Comment FTC-
2016-0098-2738)); (4) May 2015 SSI survey of 2,000 contact lens
wearers found that 34% said they did not receive their prescription
(1-800 CONTACTS (CLR RFC Comment FTC-2015-0093-0555 submitted by
Williams, Ex. C)); and (5) November 2014 SSI survey of 2,000 contact
lens wearers found that 34% said they did not receive their
prescription (1-800 CONTACTS (CLR RFC Comment FTC-2015-0093-0555
submitted by Williams, Ex. C)). As noted in the CLR SNPRM, the
manner in which a few of the questions were phrased in the 2014 and
2015 surveys raised some Commission concerns, since some questions
were leading, lacked an ``I don't know'' response option, and used a
term--``hard copy''--which not all consumers may understand. The
more recent surveys represented an improvement because they included
an option for respondents to acknowledge that they do not recall
whether they received their prescriptions, and used the term ``paper
copy'' rather than ``hard copy.'' CLR SNPRM, 84 FR 24664, 24672.
\178\ A primary difference is that contact lens exams involve a
lens ``fitting,'' in which consumers try on the lenses, and
prescriptions are only to be provided after the fitting is complete.
Fittings can entail sending consumers home with a set of lenses to
try out for a few days, and thus sometimes the prescriber will not
provide the prescription until after this process. This sometimes
leads consumers to think they should have been provided their
prescriptions when, in fact, the fitting was not yet complete. There
is no such fitting for eyeglass prescriptions. In theory, this
should mean that fewer eyeglass patients are confused as to whether
they did or did not receive their prescriptions when they were
supposed to. The fact that the percentage of eyeglass users surveyed
who said they did not receive their prescriptions is roughly the
same as, or even higher than, that of contact lens wearers surveyed
adds considerable credence to both types of surveys, and provides
further support for the conclusion that a substantial number of
consumers are not automatically receiving their prescriptions from
prescribers as the Rule requires.
\179\ As noted, supra note 171, a small number of consumer
commenters to the CLR stated that although their prescribers fail to
give them their contact lens prescriptions, they typically do
provide them with their eyeglass prescription after each eye exam.
See, e.g., Hall (CLR WS Comment FTC-2017-0099-0227); Krainman (CLR
NPRM Comment FTC-2016-0098-1373); Zeledon (CLR NPRM Comment FTC-
2016-0098-1377). The Commission has not seen empirical data that
supports this (and, in fact, it appears to be contradicted by the
consumer survey data).
---------------------------------------------------------------------------

It is important to acknowledge that no survey is perfect, and all
surveys are subject to methodological limitations, as well as limits
commonly associated with survey evidence. The Commission has also
recognized, however, that multiple surveys conducted by different
sources at different times with similar results can bolster the
credibility of each individual survey.\180\ 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 find or receive any reliable consumer-survey data rebutting or
contradicting the submitted findings for either contact lens users or
eyeglass wearers, or establishing (other than anecdotally) that
consumers consistently receive their prescriptions from
prescribers.\181\
---------------------------------------------------------------------------

\180\ See CLR Final Rule, 85 FR 50668, 50675; CLR SNPRM 84 FR
24664, 24673.
\181\ See CLR Final Rule, 85 FR 50668, 50675.
---------------------------------------------------------------------------

Consumer behavior and third-party seller experience may also reveal
the level of prescriber compliance with the automatic prescription
release requirement. For example, comments submitted pursuant to the
rulemaking process, and staff communications with industry, indicate
that many consumers who attempt to purchase eyeglasses from third
parties do not present their prescriptions.\182\ These consumers must
either request a copy of their prescriptions from their prescribers or
request that the sellers do so.\183\ This suggests that these consumers
were not provided with a copy of their prescriptions as required by the
Rule.\184\
---------------------------------------------------------------------------

\182\ See Warby Parker (Comment #0817 submitted by Kumar).
\183\ According to Warby Parker (Comment #0817 submitted by
Kumar), before it processes an order it verifies every prescription
by viewing a copy of the prescription or speaking with the
customer's prescriber. In discussions with Warby Parker, the company
has indicated that in 12 percent of all prescription eyewear orders
(including both online and in-store orders), consumers utilize what
is known as a ``call doctor'' request, whereby the customer requests
that Warby Parker call the prescriber on behalf of the customer to
obtain prescription information. However, the company noted that as
of March 15, 2017, 15 percent of all ``call doctor'' requests Warby
Parker made on behalf of its customers have been unanswered (i.e.,
the prescriber has not provided the requested prescription
information to Warby Parker). As a result, Warby Parker believes it
may be more efficient for a customer to request the prescription
information from the provider.
\184\ It is reasonable to expect that if consumers possessed
copies of their prescriptions, many would provide them to third-
party sellers instead of asking the sellers to obtain their
prescriptions from their prescribers. It is also possible, however,
that some consumers could have received copies of their
prescriptions but misplaced them, or simply thought it easier for
the third-party seller to obtain copies of the prescription than to
locate and provide the copies themselves in the format requested by
the seller.
---------------------------------------------------------------------------

In terms of the scope of this issue, Warby Parker commented that it
is required to expend substantial resources ``persuad[ing prescribers]
to provide the information required to fill a consumer order,'' and
that it informs between 50 and 100 consumers per day that it is unable
to complete their eyeglass orders.\185\ In addition, more than 20
consumers commented in this rule review that, when they tried to
purchase eyeglasses, they asked their eyeglass sellers to obtain or
verify the prescription with the prescribers, often without
success.\186\ Although this type

[[Page 261]]

of data does not allow the Commission to conclusively determine the
level of prescriber compliance with automatic prescription release, or
the number or percentage of consumers who might not have received a
copy of their eyeglass prescription, it likely supports the finding
that many patients are not automatically receiving a copy of their
eyeglass prescriptions.
---------------------------------------------------------------------------

\185\ Comment #0817 submitted by Kumar. Unlike with contact
lenses, prescribers are not required by rule to verify eyeglass
prescription requests from third-party sellers.
\186\ See, e.g., Debnam (Comment #0039); White (Comment #0053);
Kidwell (Comment #0054); Averett (Comment #0057); Silva-Sadder
(Comment #0065); Tresham (Comment #0075); Ramiah (Comment #0139);
Capurso (Comment #0149); Kulp (#0150); Lass (Comment #0197); Moran
(Comment #0202); Wilbur (Comment #0215); Vieira (Comment #0237);
Lavieri (Comment #0242); Donovan (Comment #0330); Panaccio (Comment
#0340); Kingsley (Comment #0356); Gartland (Comment #0370); Gold
(Comment #0340); Stout (Comment #0527); Crollini (Comment #0607).
These commenters stated that their online orders were delayed, made
more difficult, or defeated altogether, when their prescribers would
not provide their prescription information.
---------------------------------------------------------------------------

Lastly, it must be acknowledged that the same structural issue--an
``inherent conflict of interest'' in that prescribers sell the items
they prescribe--that led the Commission to enact the Eyeglass Rule and
CLR, and for Congress to enact the FCLCA,\187\ and that the Commission
cited as an ongoing factor in its decision to amend and strengthen the
CLR,\188\ still exists with respect to the eyeglass market and the
Rule. According to some industry sources, eyeglass sales amount to
approximately 37 to 44 percent of an optometric practice's gross
revenue, with gross profit on eyeglass sales in the area of 62
percent.\189\ While many prescribers have noted that they follow
medical ethical codes that require they prioritize their patients'
health,\190\ it cannot be denied that it is contrary to prescribers'
financial self-interest for their patients to take prescriptions
elsewhere to buy eyeglasses.\191\
---------------------------------------------------------------------------

\187\ See H.R. Rep. No. 108-318, 108th Cong., 1st Sess. 4 (2003)
at 4-5 (2003) (statements of Rep. W.J. Tauzin) (noting there is a
``classic conflict of interest that robs the consumers of the
ability to shop competitively for the best price'').
\188\ CLR Final Rule, 85 FR 50668, 50678-80 (``Moreover, the
existing regulatory structure in the U.S., which bars a consumer
from obtaining contact lenses without a prescription while
permitting prescribers to sell what they prescribe, creates
regulatory-based economic incentives for some prescribers to not
release prescriptions, or to not release them unless requested by
the consumer.'').
\189\ ECP University, ``Key Metrics: Assessing Optometric
Practice Performance & Best Practices of Spectacle Lens Management
Report,'' 25, 40-41; see also note 66, supra.
\190\ AOA (Comment #0849 submitted by Peele). See also Leeper
(CLR NPRM Comment FTC-2016-0098-0798); MacDonald (CLR NPRM Comment
FTC-2016-0098-1586); Aman (CLR NPRM Comment FTC-2016-0098-2523); Woo
(CLR NPRM Comment FTC-2016-0098-2254); Talley (CLR RFC Comment FTC-
2015-0093-0601).
\191\ This, of course, was the basis for the Eyeglass Rule in
the first place. The Commission determined that there was a long
documented history of prescribers taking action to prevent or
discourage patients from buying eyeglasses from third parties. See
Eyeglass I Rule, 43 FR 23992, 24003. Even apart from any intentional
actions prescribers may engage in to flout the Rule, this financial
self-interest may result in prescriber bias to steer patients to
purchasing glasses in-house. As the Supreme Court has observed,
``established ethical standards may blend with private
anticompetitive motives in a way difficult even for market
participants to discern. Dual allegiances are not always apparent to
an actor.'' N.C. State Bd. of Dental Exam'rs v. FTC, 574 U.S. 494,
505 (2015). While some prescribers may sincerely believe that, from
a health perspective, it is in their patients' best interest to
obtain their eyeglasses from their prescriber, the Rule mandates
that this decision belongs to the patient.
---------------------------------------------------------------------------

7. Evidence Regarding Consumers' Awareness of Their Right To Receive
Their Prescription
As with the question of Rule compliance, there was little consensus
among commenters as to whether consumers are fully aware of their right
to their prescriptions.\192\ In its comment, the AOA asserted that
patients are now well-informed of their ability to obtain their
eyeglass prescriptions.\193\ Other commenters disagreed, with some
eyeglass sellers asserting that many patients are still not aware of
the Rule and their rights.\194\
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\192\ The Rule's imposition of an obligation on a prescriber to
automatically release an eyeglass prescription creates a
corresponding right for consumers to receive it. See Eyeglass I
Report, supra note 6, at 269 (``By requiring the release of the
prescription in every case the public will have a clear, absolute
right to their prescriptions.'').
\193\ AOA (Comment #0849 submitted by Peele).
\194\ Opticians Association of Virginia (Comment #0647 submitted
by Nelms); NAOO (Comment #0748 submitted by Cutler); see also Warby
Parker (Comment #0817 submitted by Kumar) (stating that many
consumers are unaware of their rights and the Commission should try
to increase awareness).
---------------------------------------------------------------------------

In previous reviews of the Eyeglass Rule, the Commission received
conflicting empirical evidence regarding the extent of consumer
awareness, with some studies suggesting a relatively high degree of
awareness,\195\ and others indicating that consumers, particularly
older patients, were unaware of their right to automatically receive a
copy of their prescription.\196\ For this review, none of the
commenters submitted survey evidence specifically focused on consumer
awareness of their right to their eyeglass prescription. One commenter,
1-800 CONTACTS, however, cited a survey submitted to the Commission
during the Contact Lens Rule review which indicates that lack of
awareness of a right to an eyeglass prescription is still an
issue.\197\ According to the survey, 49 percent of prescription
eyeglass wearers are not aware that they have a right to receive a copy
of their prescription, and 51 percent are not aware that their eye exam
provider cannot charge for a copy of their prescription.\198\
---------------------------------------------------------------------------

\195\ See Eyeglass II Report, supra note 26, at 257-62 (citing
Market Facts Study for the finding that a large majority of those
surveyed knew they did not have to purchase eyeglasses from the
examining doctor and could ask for an eyeglass prescription after an
examination, although many mistakenly thought they had to ask for
it, and some thought doctors were allowed to charge extra for
providing it).
\196\ See Presiding Officer's Report, supra note 33, at 22.
\197\ See ``FCLCA Study, Focus on Prescription (Rx),'' attached
as Exhibit B to 1-800 CONTACTS (CLR RFC Comment FTC-2015-0093-0555
submitted by Williams).
\198\ Id. The manner in which the consumer awareness questions
were phrased in the survey submitted by 1-800 CONTACTS did raise
some concerns about the weight that should be accorded to the
results. In particular, the questions were leading and used a term--
``hard copy''--that some consumers might not understand. On the
other hand, the question's phrasing may have led to under-reporting
by consumers who in fact did not know their right, but did not want
to admit that, because they did not want to acknowledge that they
were unaware of their rights under federal law (this is known as
social-desirability bias). See Diamond, Reference Guide on Survey
Research, in Reference Manual on Scientific Evidence, 2nd. ed., 248-
264 (Federal Judicial Center 2000), available at https://wwws.law.northwestern.edu/faculty/fulltime/diamond/papers/referenceguidesurveyresearch.pdf; Fowler, How Unclear Terms Affect
Survey Data, The Public Opinion Quarterly (Summer 1992), available
at https://www.jstor.org/stable/2749171; see generally, Carl A.
Latkin, et al., The relationship between social desirability bias
and self-reports of health, substance use, and social network
factors among urban substance users in Baltimore, Maryland, 73
Addictive Behaviors 133-136 (2017) (social desirability bias is the
tendency of survey respondents to answer questions in a manner that
will be viewed favorably by others, and can skew survey results by
over-reporting attitudes and behaviors that may be considered
desirable attributes, while underreporting less desirable
attributes). Social-desirability bias in this instance likely
underestimates the number of patients unaware of their right to
their prescription. In other words, the way the question was phrased
could lead to results that make it appear that more patients are
aware of their rights than is, in fact, the case. See ``FCLCA Study,
Focus on Prescription (Rx),'' attached as Exhibit B to 1-800
CONTACTS (CLR RFC Comment FTC-2015-0093-0555 submitted by Williams)
(One question was phrased, ``Are you aware that it is your right
under federal law, as a patient to receive a hard copy of your
contact lens/eye glasses prescription from your eye exam provider?''
and the other asked, ``Are you aware of the following. . .--Your eye
exam provider cannot charge you for an actual hard copy of your
prescription?'').
---------------------------------------------------------------------------

Furthermore, multiple other consumer surveys examined during the
Contact Lens Rule review indicate that a high percentage of consumers
(46 to 60 percent, according to submitted data) do not realize they are
entitled to receive their contact lens prescription,\199\ and it is
likely that many of these consumers are also

[[Page 262]]

unaware they are entitled to their eyeglass prescription.
---------------------------------------------------------------------------

\199\ CLR SNPRM, 84 FR 24664, 24675 (citing a Caravan ORC
International survey submitted by Consumer Action (CLR NPRM Comment
FTC-2016-0098-2954) and SSI survey submitted by 1-800 CONTACTS (CLR
NPRM Comment FTC-2016-0098-2738)).
---------------------------------------------------------------------------

8. Analysis of Evidence Regarding Automatic Prescription Release
Provision
Having considered the evidence compiled thus far--including the
comments, empirical surveys, ongoing pattern of consumer complaints and
anecdotal reports, and relevant evidence submitted during the CLR
review (and the Commission's determinations in that regard), along with
the industry's documented history of failing to provide eyeglass
prescriptions automatically even when obligated by state and federal
law--in conjunction with the intent, purpose, and history of the
Eyeglass Rule, the Commission believes that there is still a
significant need for the automatic prescription release provision. The
Commission also concludes that improving compliance with, and consumer
awareness of, the provision is necessary to further the goals of the
Rule. Finally, the Commission sees a benefit--to both consumers and
prescribers--in aligning the prescription release requirements and
practices for both eyeglass and contact lens prescriptions.
At the time of the Rule's initial implementation, the Commission
determined that failure to release prescriptions was pervasive and
widespread, and that this constituted an unfair act or practice under
section 5.\200\ In subsequent Eyeglass Rule reviews, the Commission
noted that despite the Rule, compliance remained a problem, and
expressed concern that if the automatic release requirement were
removed, more prescribers might return to the practice of refusing or
failing to release prescriptions.\201\ And while some commenters assert
that automatic prescription release is now such standard practice that
it would be adhered to even absent a rule, the weight of the evidence
in this Rulemaking clearly favors retaining the automatic release
requirement. Furthermore, the Commission notes that, when it relied on
voluntary compliance in the past, compliance was poor.\202\
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\200\ Eyeglass I Rule, 43 FR 23992, 23998.
\201\ Ophthalmic Practice Rules, 69 FR 5451, 5453 (noting that
in a 1989 rule review, the Commission had found ``significant non-
compliance,'' and finding that as of 2004, lack of compliance was
still a problem).
\202\ See note 9, supra.
---------------------------------------------------------------------------

The Commission remains concerned that a lack of compliance with the
Rule is still prevalent, and that removing the automatic prescription
release requirement might further reduce the number of consumers who
receive their prescriptions, whether automatically or on request. The
Commission has not seen evidence suggesting that the structure of the
market or financial incentives for prescribers have changed in such a
way as to make the automatic prescription release requirement no longer
necessary. Arguably, the incentive that prescribers have to steer
patients to in-house optical dispensaries rather than giving patients
their prescription remains the same, if not stronger,\203\ than when
the Rule was first implemented. Moreover, the evidentiary record
indicates that a significant percentage of prescribers still do not
automatically provide a prescription. The evidence also suggests that
many consumers are still not fully aware of their right to receive or
obtain their prescription. Furthermore, the population of eyeglass
wearers is not static, and large numbers of consumers become first-time
wearers each year. The Commission thus concludes that many consumers
cannot reasonably avoid prescribers' failure to automatically release
prescriptions as required by the Rule. It is important that this be
remedied, and that consumers are aware of, and receive the benefits of,
their right to comparison-shop for eyeglasses.
---------------------------------------------------------------------------

\203\ See Section I.C, supra; see also Burchell (Comment #0866)
(positing that online dispensaries will put increasing pressure on
prescribers' profit margins); NAOO (Comment #0748 submitted by
Cutler) (noting that optometrists still earn the majority of their
revenue from selling eyewear they prescribe); Professional Opticians
of Florida (Comment #0803 submitted by Couch) (noting a dramatic
increase in the number of prescribers' offices that sell eyewear).
---------------------------------------------------------------------------

The Commission also has not seen evidence that the automatic
release provision imposes an unreasonable burden on prescribers, or
that there is a substantial countervailing benefit that would result
from eliminating the automatic release requirement. Indeed, while a few
prescribers asserted it was wasteful or unnecessary,\204\ other
commenters felt it was not a significant burden,\205\ and the AOA
stated that the automatic release provision was not ``harmful'' to
prescribers.\206\ The Commission previously concluded that the
requirement enhances consumer choice among eyeglass sellers at a
minimal compliance cost to eye care prescribers.\207\ Moreover, since
the automatic prescription release provision has been in existence
since 1978, maintaining it as part of the Rule would not impose new
costs on prescribers. By contrast, eliminating it for eyeglass
prescriptions would create the potential for confusion amongst patients
and prescribers alike, since the automatic prescription release
requirement still applies to contact lens prescriptions.\208\
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\204\ See Lunsford (Comment #0346) (waste of time and resources
to provide each patient with a copy of his or her prescription);
Barnes (Comment #0043) (a lot of patients don't want a copy and end
up throwing it away).
\205\ NAOO (Comment #0748 submitted by Cutler) (``Based on NAOO
member experience, the thousands of optometrists affiliated in co-
location with NAOO member companies regularly comply with the
Eyeglass Rule and the Contact Lens Rule with little or no added cost
or other burden on the eye care practice.'').
\206\ Comment #0849 submitted by Peele.
\207\ See Ophthalmic Practice Rules, 69 FR 5451, 5453.
\208\ 16 CFR 315.
---------------------------------------------------------------------------

The Commission also concludes that the potential benefits of
increasing the number of patients who receive their prescriptions
automatically are substantial. These benefits include: increased
patient flexibility and choice in comparison-shopping for eyeglasses;
fewer disputes between consumers and prescribers; fewer requests from
patients for a copy of their prescription, and arguably, fewer requests
for a copy of, or a verification of, a prescription from third-party
sellers of eyeglasses, which some prescribers find burdensome; \209\
and a reduction in costs and voided sales by third-party sellers.\210\
The cumulative effect of increased compliance and consumer awareness
would likely increase competition, lower costs, and improve convenience
and flexibility for patients, sellers, and prescribers.
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\209\ Cerri (Comment #0509); Kiener (Comment #0593); Bolenbaker
(Comment #0633).
\210\ See Sections I.B.1, IV.A.2, supra, and Sections IV.A.5,
IV.C.1, infra.
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9. Proposals for Improving Compliance and Consumer Awareness
Having reached a determination that the automatic release provision
should be retained, and that it would be beneficial to increase
compliance with, and awareness of, the provision, the Commission now
evaluates proposals for how best to achieve this goal.
a. Proposal To Increase Enforcement
Of the commenters who discussed the automatic prescription release
provision, very few offered suggestions for amending the Rule to
increase compliance with, or consumer awareness of, this
provision.\211\ A few, however, suggested that the Commission should
improve compliance by bringing more enforcement actions against
prescribers

[[Page 263]]

who fail to automatically release prescriptions.\212\ Warby Parker, in
particular, noted that Commission enforcement actions have been
``virtually non-existent,'' \213\ and asserted that more aggressive
enforcement would quickly increase both prescriber compliance and
consumer awareness.\214\ To assist the Commission in its enforcement,
Warby Parker also suggested creating a more ``user-friendly'' online
complaint process for consumers.\215\
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\211\ One commenter, the Opticians Association of Virginia,
suggested that prescribers should be ``reminded'' of their
obligation to release prescriptions, although the comment did not
specify how prescribers should be reminded. Comment #0647 submitted
by Nelms.
\212\ Warby Parker (Comment #0817 submitted by Kumar);
Professional Opticians of Florida (Comment #0803 submitted by
Couch).
\213\ Comment #0817 submitted by Kumar.
\214\ Id.
\215\ Id. This suggestion is discussed in Section VI, infra.
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The Commission recognizes the need for increased enforcement of the
automatic prescription release provision. Simply put, with the evidence
in the Rulemaking showing significant noncompliance with this provision
after 40 years, it is clear that more enforcement is necessary to
improve industry adherence. In this regard, 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. 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.
Commission staff first identified this issue in its Eyeglass II Report,
where it explained that the automatic release requirement had not
helped to avoid ``evidentiary squabbles''--as the Commission had hoped
it would \216\--but instead had increased them, because whether or not
a prescriber had released a prescription could not, in most cases, be
ascertained by documentary evidence.\217\ Accordingly, the Commission
has brought only one enforcement action against an eyeglass prescriber
for failure to comply with the automatic release provision.\218\ The
Commission believes that improvement in its ability to assess and
verify compliance with the Rule's automatic prescription release
requirements will increase its ability to monitor and enforce
compliance.\219\
---------------------------------------------------------------------------

\216\ Eyeglass I Rule, 43 FR 23992, 23998.
\217\ Eyeglass II Report, supra note 26, at 275-76.
\218\ United States v. Doctors Eyecare Ctr., Inc., No. 3:96-cv-
01224-D (N.D. Tex. June 24, 1996). The complaint alleged that the
eye care center only released prescriptions when patients asked for
them, and included waivers of liability on patients when doing so.
The prescriber paid a $10,000 civil penalty and was enjoined from
future violations of the Eyeglass Rule. See Press Release, Fed. Tr.
Comm'n, Dallas Eyecare Center Agrees to Settle Charges That They
Failed to Give Consumers Copies of Their Eyeglass Prescriptions (May
3, 1996), https://www.ftc.gov/news-events/press-releases/1996/05/dallas-eyecare-center-agrees-settle-charges-they-failed-give.
\219\ Separately, the Commission does not believe it necessary
to amend the Rule to explicitly state that violations of the Rule
constitute a violation of the Federal Trade Commission Act, as some
commenters have proposed. See Warby Parker (Comment #0817 submitted
by Kumar); 1-800 CONTACTS (Comment #0834 submitted by Williams); see
also Santini (Comment #0047) (``There should be clear penalties if
consumers encounter resistance at any point [in] obtaining their
spectacle Rx.''). The existing language in Sec. 456.2 of the Rule,
in conjunction with the Commission's authority to prescribe the
Ophthalmic Practice Rules under section 18 of the FTC Act, make it
sufficiently clear that violations of the Rule are unfair acts or
practices under section 5 of the FTC Act, and can be enforced as
such. See 16 CFR 456.2; 15 U.S.C. 57a; 15 U.S.C. 45.
---------------------------------------------------------------------------

b. Proposal To Require an Eye Care Patients' Bill of Rights
Commenter Warby Parker proposed that the Rule be amended to require
that prescribers provide patients with written notices informing them
of their right to their prescription.\220\ According to the proposal,
such notices would take the form of a ``bill of rights'' for eyeglass
patients, notifying them of their rights under the Eyeglass Rule,
including their right to receive their prescription free of charge and
to purchase glasses from a provider of their own choosing.\221\ Such a
proposal, if implemented and complied with, might increase consumer
awareness and, presumably, increase the percentage of patients who
receive prescriptions from their providers. Providing the document
would also remind prescribers and their staffs of their obligation to
provide patients with their prescriptions, and would remind patients to
ask for their prescriptions in the event that prescribers failed to
provide them without request, as the Rule requires.
---------------------------------------------------------------------------

\220\ Warby Parker (Comment #0817 submitted by Kumar). Warby
Parker proposed this written notice for the Contact Lens Rule as
well ((CLR RFC Comment FTC-2015-0093-0578 submitted by Kumar), as
did 1-800 CONTACTS (CLR RFC Comment FTC-2015-0093-0555 submitted by
Williams) and Lens.com (CLR RFC Comment FTC-2015-0093-0666 submitted
by Samourkachian).
\221\ Warby Parker (Comment #0817 submitted by Kumar). The
Commission has considered similar proposals in the past, including
during the initial Eyeglass I rulemaking, when it was suggested that
the prescription itself should include a notice declaring that it
could be taken to any optical dispensary to have eyeglasses
fabricated. At that time, the Commission and staff concluded that
such a notice was unnecessary since advertising by opticians would
likely make patients aware of their prescription's portability. See
Eyeglass I Report, supra note 6, at 278; Eyeglass I Rule, 43 FR
23992, 23998.
---------------------------------------------------------------------------

A bill of rights would also impose a relatively small burden upon
prescribers, since they would only need to provide a brief, standard,
pre-drafted form for each patient, and would not have to perform
additional recordkeeping. On the other hand, patients already receive
forms and other paperwork when they visit a prescriber, increasing the
possibility that patients might not read or attend to the information
in a bill of rights.
Moreover, the Rule already requires that prescribers provide
patients with copies of their prescriptions, and yet evidence indicates
that prescribers do not always do so. Without some mechanism to ensure
prescriber compliance with the new obligation to provide a bill of
rights, the requirement might not provide material benefits. For
example, under Warby Parker's proposal, patients would be given a copy
of the bill of rights to take with them, but there would be no
requirement that prescribers maintain records of their compliance.
Therefore, the bill of rights proposal does not require the type of
prescriber recordkeeping that would allow for better Rule monitoring
and enforcement, and help resolve disputes between patients and
prescribers over whether a prescription had been released. It is thus
possible that adding a bill of rights requirement would impose an
increased burden on prescribers without providing tangible,
countervailing benefits to consumers or prescribers.
Many prescribers might also object to an eyeglass patient's bill of
rights out of concern that it might impart the impression to consumers
that prescribers are untrustworthy. Prescribers voiced numerous
objections of this type during the CLR review when the Commission
proposed including a sentence on a consumer acknowledgment of
prescription stating, ``I understand I am free to purchase contact
lenses from the seller of my choice.'' \222\ According to prescribers,
such a statement implies that they have done something wrong.\223\ It
seems likely prescribers would oppose an eyeglass patient's bill of
rights for the same reason.
---------------------------------------------------------------------------

\222\ See CLR SNPRM, 84 FR 24664, 24678-79.
\223\ Id.
---------------------------------------------------------------------------

In fact, a similar bill of rights proposal was put forth by
commenters to the Contact Lens Rule \224\ and considered,

[[Page 264]]

and the Commission ultimately decided against adopting it for many of
the reasons cited herein.\225\ In light of these considerations, the
Commission does not propose amending the Rule to require that
prescribers provide patients with a bill of rights.
---------------------------------------------------------------------------

\224\ 1-800 CONTACTS (CLR RFC Comment FTC-2015-0093-0555
submitted by Williams); Lens.com (CLR RFC Comment FTC-2015-0093-0666
submitted by Samourkachian); see CLR NPRM, 81 FR 88526, 88532-33.
\225\ CLR NPRM, 81 FR 88526, 88532-33.
---------------------------------------------------------------------------

c. Proposal To Require Signage
Some commenters proposed that one way to increase compliance with,
and awareness of, the automatic release provision, would be to amend
the Rule to require that prescribers post conspicuous signage in their
offices informing patients of their right to their prescriptions.\226\
Such signage is currently required by state law in California.\227\
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\226\ Tedesco (Comment #0042); Warby Parker (Comment #0817
submitted by Kumar).
\227\ Section 2554 of the California Business and Professions
Code requires that each prescriber office post, in a conspicuous
place, a notice informing patients that eye doctors are required to
provide patients with a copy of their spectacle prescriptions upon
completion of the exam, and that patients may take their
prescription to any eye doctor or registered dispensing optician to
be filled. Cal. Bus. & Prof. Code Sec. 2554.
---------------------------------------------------------------------------

If adopted, such a requirement could provide some of the same
benefits as a bill of rights by educating consumers and, presumably,
might also increase the percentage of patients who receive their
prescription from their provider. A sign could also serve as a reminder
to patients to ask for their prescription in the event a prescriber
fails to provide it. Furthermore, a sign would impose relatively little
burden on prescribers, since it would only have to be posted once.
Lastly, enforcing such a provision could be relatively straightforward,
since the Commission could simply perform spot checks on prescribers'
offices.
On the other hand, the Commission lacks evidence about the effects
of California's signage requirement on automatic prescription release.
It is unclear how many patients would notice a sign at prescribers'
offices, particularly since many prescribers' offices already have
numerous ads or other postings about various patient rights,
requirements, and obligations. It is possible that in the context of
prescribers' offices, a signage requirement would not be as effective
in increasing consumer awareness as a requirement that consumers be
handed or shown a specific document. A sign would also not require a
prescriber, or the prescriber's staff, to interact with each patient
about their prescription, so it would serve as less of a reminder for
them to provide patients with their prescriptions. And while the
Commission might be able to verify compliance with a signage
requirement by performing spot checks at prescribers' offices, such
visits would not reveal whether the prescribers' office was complying
with the Rule's automatic prescription release provision. Moreover,
since signage would increase prescription release only if more
consumers see a sign and ask for their prescription, relying on signage
essentially shifts the burden of prescription release compliance and
enforcement to the consumer, an approach the Commission has repeatedly
rejected in the past.\228\
---------------------------------------------------------------------------

\228\ See Eyeglass I Rule, 43 FR 23992, 23998; Eyeglass II Rule,
54 FR 10285, 10286-87, 10303, 10313 & nn.180 & 181; see also
Eyeglass II Report, supra note 26, at 255-58 (reporting the Market
Facts Study results).
---------------------------------------------------------------------------

During its review of the CLR, the Commission gave extensive
consideration to the possibility of using signage, particularly as an
alternative to some form of written acknowledgment of prescription from
the patient.\229\ The Commission ultimately decided against a signage
provision, after determining that the benefits were limited and that
requiring signage would be significantly less effective at ensuring
contact lens prescription release than requiring a written patient
confirmation.\230\ The Commission reaches the same conclusion with
respect to proposed signage reminding consumers about their eyeglass
prescriptions.\231\
---------------------------------------------------------------------------

\229\ See CLR NPRM, 81 FR 88526, 88534; CLR SNPRM, 84 FR 24664,
24679; CLR Final Rule, 85 FR 50668, 50684-85.
\230\ CLR Final Rule, 85 FR 50668, 50685.
\231\ The Commission further notes that imposing a signage
requirement for eyeglass prescriptions, where one does not exist for
contact lens prescriptions, could result in confusion for both
consumers and prescribers.
---------------------------------------------------------------------------

d. Proposal To Require a Confirmation of Prescription Release
Having determined that some type of documentation is necessary to
increase adherence and improve enforcement of the Rule, the Commission
next turns to consider what type of documentation should be required.
In 2020, the Commission amended the Contact Lens Rule to add a
requirement that prescribers retain documentation confirming that they
released contact lens prescriptions to patients as required by the
CLR.\232\ The CLR's confirmation requirement was adopted subsequent to
the publication of the ANPR, and while none of the commenters to the
ANPR explicitly proposed a signed acknowledgment, commenters to the CLR
review made such a suggestion, and the Commission ultimately determined
there would be substantial benefits to such an approach. In
promulgating the requirement, the Commission stated its belief that the
confirmation requirement would increase compliance with prescription
release requirements and awareness of the CLR's requirements among
consumers by mandating that prescribers present a document for patients
to sign confirming that they received their prescription at the end of
their contact lens fitting.\233\
---------------------------------------------------------------------------

\232\ See CLR Final Rule, 85 FR 50668, 50687-88; 16 CFR
315.3(c).
\233\ See CLR Final Rule, 85 FR 50668, 50687-88.
---------------------------------------------------------------------------

The Confirmation of Prescription Release provision added to the CLR
in 2021 requires prescribers do one of the following:
(A) Request that the patient acknowledge receipt of the contact
lens prescription by signing a separate statement confirming receipt of
the contact lens prescription;
(B) Request that the patient sign a prescriber-retained copy of a
contact lens prescription that contains a statement confirming receipt
of the contact lens prescription;
(C) Request that the patient sign a prescriber-retained copy of the
sales receipt for the examination that contains a statement confirming
receipt of the contact lens prescription; or
(D) If a digital copy of the prescription was provided to the
patient (via methods including an online portal, electronic mail, or
text message), retain evidence that such prescription was sent,
received, or made accessible, downloadable, and printable.\234\
---------------------------------------------------------------------------

\234\ 16 CFR 315.3(c).
---------------------------------------------------------------------------

In order to relieve prescribers of the burden of crafting their own
confirmation language, the CLR provides sample language for options
(A), (B), and (C), but also allows prescribers to create their own
wording for the signed confirmation if they so desire.\235\ Prescribers
are required to maintain records or evidence of consumer confirmation,
or that a digital copy was provided to the patient, for at least three
years.\236\ Lastly, in order to limit the burden as much as possible,
the CLR confirmation requirement only applies to prescribers with a
financial interest in the sale of contact lenses.\237\
---------------------------------------------------------------------------

\235\ Id. at 315.3(c)(1)(ii).
\236\ Id. at 315.3(c)(2).
\237\ Id. at 315.3(c)(3).
---------------------------------------------------------------------------

The Commission believes a similar requirement for eyeglass
prescriptions would have many benefits. A signed patient confirmation
of release for eyeglass prescriptions would notify and

[[Page 265]]

remind consumers of their prescription portability rights and, in all
likelihood, increase the percentage who receive their prescription from
the prescriber. Providing the confirmation document, and obtaining the
patient's signature, would remind prescribers and their staffs to
provide prescriptions, and remind patients who might have received a
confirmation document (and are asked to sign) but did not receive their
prescription to ask for it.
Since the document is given to the patient, and the patient asked
to sign it, such a document is less likely to go unnoticed or unread by
patients than a bill of rights or office signage reminding patients of
their prescription rights. And requiring prescribers to retain a signed
confirmation would improve the Commission's ability to verify whether
prescribers had complied with the Rule's requirement to release
prescriptions to their patients. It would reduce the number of
instances where a filed complaint simply pits the patient's word
against that of the prescriber. Prescribers would also have valuable
documentation to present in their defense should a patient lose or
dispose of his or her prescription copy and mistakenly believe the
prescriber had not provided it, a scenario cited by at least one
commenter.\238\ In short, a confirmation of release would eliminate
certain evidentiary problems related to Rule enforcement, one of the
reasons the Commission adopted automatic prescription release when it
promulgated the Eyeglass Rule in the first place.\239\ Ultimately,
adding a confirmation of release requirement should result in more
consumers having a copy of their prescriptions, and thus improve
consumer flexibility and choice, reduce the number of eyeglass sellers
and consumers who call prescribers to obtain patient prescriptions,
improve competition in the market for eyeglasses and frames, and lower
prices for consumers.\240\
---------------------------------------------------------------------------

\238\ Barnes (Comment #0043) (``I sometimes worry that if a
patient chose not to take [the prescription], we would later be
accused of not offering it to them.''). Prescribers have also
verbally informed Commission staff about such occurrences when
responding to warning letters about failure to release
prescriptions.
\239\ Eyeglass I Rule, 43 FR 23992, 23998.
\240\ In addition, adding a Confirmation of Prescription Release
requirement to the Eyeglass Rule would apply similar requirements to
both eyeglass and contact lens prescription release, and would thus
avert consumer and prescriber confusion about when patients had to
sign a confirmation of prescription release.
---------------------------------------------------------------------------

The primary drawback to requiring a signed confirmation is the
increased recordkeeping burden imposed on prescribers, since they would
have to provide the piece of paper and retain the signed form for a
certain period of time.\241\ This recordkeeping burden could be reduced
to the extent that prescribers have adopted electronic medical record
systems, especially those where patient signatures can be recorded
electronically and inputted automatically into the electronic record.
Furthermore, prescribers could scan signed paper copies of the
confirmation and store those forms electronically to lower their
compliance costs. Moreover, the added paperwork requirement may apply
only to prescribers who use a separate form to get the patient's signed
confirmation, since those who opt to add the confirmation to a copy of
the patient's prescription or sales receipt would, presumably, be
maintaining those records anyway. Prescribers also will likely have an
established means of collecting patient confirmations and maintaining
records for the purpose of complying with the CLR. The marginal cost of
adopting such forms and systems to include eyeglasses prescriptions is
likely to be very low. Accordingly, the Commission believes that any
recordkeeping burden would be relatively minimal and outweighed by the
benefits described above.
---------------------------------------------------------------------------

\241\ Prescribers who choose to offer a digital copy of the
prescription would avoid this aspect of recordkeeping for those
patients who consent to receive a digital copy.
---------------------------------------------------------------------------

One concern is the possibility that requiring consumers to sign a
confirmation that they received their prescription will sow doubts
about prescriber integrity, and sully the doctor-patient
relationship.\242\ The Commission believes this to be unlikely.
Consumers are accustomed to signing acknowledgments or receipts.\243\
Many pharmacists require patients to acknowledge that they do not have
questions upon receiving a prescription; physicians' offices require
visitors to sign in; and patients are accustomed to signing HIPAA
acknowledgment forms signifying they received a provider's Notice of
Privacy Practices (``NPP'').\244\ The Commission is not aware of
evidence that such requirements sow distrust on the part of the person
signing the receipt. The Commission believes this will hold true for a
Confirmation of Prescription Release for eyeglass prescriptions,
particularly since prescribers can devise their own language of
confirmation, and since prescribers will already be obtaining patients'
signatures from those who obtain contact lens prescriptions.
---------------------------------------------------------------------------

\242\ The Commission considered this concern during its review
of the CLR (CLR Final Rule, 85 FR 50668, 50680-81) and came to the
conclusion that this concern is not significant enough to change the
result.
\243\ This fact was also considered in the CLR evaluation. Id.
\244\ The U.S. Department of Health & Human Services (``HHS'')
proposed eliminating the requirement to obtain an individual's
written acknowledgment of receipt of the provider's NPP, but
patients have had experience signing such acknowledgements for many
years. See Proposed Modifications to the HIPAA Privacy Rule To
Support, and Remove Barriers to, Coordinated Care and Individual
Engagement, 86 FR 6446, 6485 (Jan. 1, 2021). As explained in the
CLR, the impetus for the NPP signed acknowledgment and that for the
CLR (and Eyeglass Rule) prescription release confirmation were very
different, and--in contrast to eye prescriptions--there is little
evidence that providers were not providing patients with their NPPs,
and thus significantly less need for a patient acknowledgment of
receipt. CLR Final Rule, 85 FR 50668, 50684-85 (noting that the
primary intent of the HIPAA signed-acknowledgment was to provide
patients an opportunity to review the provider's Notice of Privacy
Practices, discuss concerns related to their private health
information, and request additional confidentiality, not to remedy a
lack of compliance, and that the HHS record does not contain
empirical evidence showing that doctors are not fulfilling their
obligations to provide Notices of Privacy Practices to patients);
see also Request for Information on Modifying HIPAA Rules to Improve
Coordinated Care, Office for Civil Rights, Department of Health and
Human Services, 83 FR 64302, 64308 (Dec. 14, 2018) (discussing the
intent of the HIPAA signed acknowledgment); see also generally
Comments in Response to Request for Information on Modifying HIPAA
Rules to Improve Coordinated Care, Office for Civil Rights,
Department of Health and Human Services, https://www.regulations.gov/document/HHS-OCR-2018-0028-0001.
---------------------------------------------------------------------------

10. The Commission's Proposal To Require a Signed Confirmation of
Prescription Release
After consideration of the evidence and proposals, the Commission
proposes to amend the Rule to add a Confirmation of Prescription
Release requirement. The Commission believes such a provision will
increase the number of patients who receive their prescriptions, inform
patients of the Rule and 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
requirement of the Contact Lens Rule.\245\ The addition of a patient
confirmation requirement accomplishes the desired

[[Page 266]]

objectives of the Rule with little increased burden on prescribers.
---------------------------------------------------------------------------

\245\ Should a prescriber wish to create a single document
confirming receipt of both an eyeglass and a contact lens
prescription (in cases where both prescriptions are finalized at the
same time), the Commission believes such a document could meet the
requirements of both rules so long as there are separate statements
and signature lines for the contact lens prescription and the
eyeglass prescription. Such a practice could help prescribers reduce
any burden associated with confirmations.
---------------------------------------------------------------------------

The Commission therefore proposes to amend Sec. 456.3 to add the
requirement 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.
If the prescriber elects to confirm prescription release via
paragraphs (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 (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.
The full text of the proposed Rule amendment is located at the end
of this document.

B. Other Issues Surrounding Patients' Access to Eyeglass Prescriptions

1. Prescriber Responsibilities To Provide Additional Copies of
Prescriptions
The Eyeglass Rule requires an ophthalmologist or optometrist to
provide ``one copy'' of the patient's prescription immediately after
the completion of the eye exam.\246\ In the ANPR, the Commission sought
comment on whether it should amend the Rule to require prescribers to
provide duplicate copies of prescriptions to patients who no longer
have access to the original.\247\ Patients may need an additional copy
because they lost or misplaced their prescriptions, or because the
prescription was not returned after they ordered eyeglasses.\248\ The
Commission believes that there is often a valid need for consumers to
obtain additional copies of their prescriptions, and encourages
prescribers to provide them when requested. However, in a previous Rule
review, the Commission considered this issue and determined not to
mandate a requirement to provide additional copies since it did not
receive sufficient evidence indicating that the practice of refusing to
release additional copies of eyeglass prescriptions was prevalent.\249\
After reviewing the evidence in the instant rulemaking record, the
Commission, for this same reason, declines to amend the Rule to require
prescribers to provide patients with additional copies of eyeglass
prescriptions upon request.
---------------------------------------------------------------------------

\246\ 16 CFR 456.2(a).
\247\ Eyeglass Rule ANPR, 80 FR 53274, 53276.
\248\ The Commission distinguishes a request for an additional
copy of a prescription from a request for an initial copy of a
prescription in instances when a consumer did not receive the
prescription immediately after the completed eye examination. In the
latter event, the prescriber must provide a copy of the prescription
without a fee unless the prescriber did not release the prescription
immediately following the examination because the patient failed to
pay for the examination and the prescriber requires immediate
payment from all patients, whether or not the exam reveals a need
for ophthalmic goods. See 16 CFR 456.2(a).
\249\ See Eyeglass II Rule, 54 FR 10285, 10303.
---------------------------------------------------------------------------

Optometrists, opticians, consumers, a consumer advocate, an online
seller, and a telehealth prescriber commented in favor of amending the
Rule to require that prescribers provide additional copies of
prescriptions to patients that do not currently have access to their
prescription.\250\ The NAOO stated its belief that, although
optometrists affiliated with its member companies provide additional
copies upon request at no charge, the Rule should clarify that
consumers always have a right to their eyeglass prescriptions as part
of their medical records.\251\ It pointed out that, although consumers
already have a right to their prescriptions under HIPAA, the 30-day
period allotted to prescribers (and other covered entities) for the
production of medical records under HIPAA is overly long for consumers
who may need replacement eyeglasses.\252\ Warby Parker commented that
providing an additional copy furthers the original goal of the Rule to
foster comparison-shopping in that it ensures that patients have the
freedom to choose where to purchase their eyeglasses.\253\ Visibly,
formerly known as Opternative, a telehealth prescriber, stated that
such a requirement would be consistent with the Rule's intent and
furthers its purpose.\254\ Warby Parker also stated that some
prescribers refuse to provide such copies and that others charge
patients for them.\255\ One commenter stated that there is no real
impact on a prescriber's business to provide a duplicate copy, while it
allows consumers access to their prescription without needing to
undergo a new exam.\256\ Some commenters stated the prescriber should
have to release additional copies, but suggested that prescribers
should be able to impose a small administrative fee.\257\ One commenter
who supported permitting the imposition of a small fee explained that
such a fee is justified

[[Page 267]]

because the prescriber faces a burden in providing the additional copy,
and consumers should bear (or share) the responsibility for not having
safeguarded the original copy they received following their
examination.\258\ The NAOO stated that additional copies should be
provided without requiring that patients file formal HIPAA requests and
at no charge because the cost to the prescriber is trivial.\259\
---------------------------------------------------------------------------

\250\ DeMuth Jr. (Comment #0055); Ellis (Comment #0189); Prevent
Blindness (Comment #0385 submitted by Parry); Schwartz (Comment
#0514); Burchell (Comment #0866); Kiener (Comment #0593); Opticians
Association of Virginia (Comment #0647 submitted by Nelms); NAOO
(Comment #0748 submitted by Cutler); Pulido (Comment #0019);
Professional Opticians of Florida (Comment #0803 submitted by
Couch); Warby Parker (Comment #0817 submitted by Kumar); Stuart
(Comment #0841); Opternative (now Visibly) (Comment #0853 submitted
by Dallek).
\251\ Comment #0748 submitted by Cutler; see also Prevent
Blindness (Comment #0385 submitted by Parry) (calling the right to
one's own prescription a ``basic consumer right''); Professional
Opticians of Florida (Comment #0803 submitted by Couch) (stating it
is a consumer's right to have access to his or her prescription).
\252\ Comment #0748 submitted by Cutler. In 2021, HHS proposed
modifying the HIPAA Privacy Rule ``to require that access [to
protected health information] be provided `as soon as practicable,'
but in no case later than 15 calendar days after receipt of the
request, with the possibility of one 15 calendar-day extension.''
Proposed Modifications to the HIPAA Privacy Rule To Support, and
Remove Barriers to, Coordinated Care and Individual Engagement, 86
FR 6446, 6459. The Cures Act Final Rule, implementing the 21st
Century Cures Act, also requires healthcare providers to make
certain classes of data available to patients in their electronic
health records. See Section IV.B.2.b, infra. This may result in
consumers having greater access to their refraction measurements.
\253\ Comment #0817 submitted by Kumar.
\254\ Comment #0853 submitted by Dallek. Several consumers also
wrote in support of adding this requirement to the Rule. DeMuth, Jr.
(Comment #0055); Ellis (Comment #0189).
\255\ Comment #0817 submitted by Kumar.
\256\ Jozwik (Comment #0002).
\257\ Kiener (Comment #0593); Pulido (Comment #0019); see also
Burchell (Comment #0866) (stating administrative charge should
reflect the cost of the paper, other office supplies, and office
staff time; suggesting that current market supports a fee of $2-$10;
and clarifying the fee should not be a profit-making mechanism). One
commenter recommended that the Rule mandate prescribers provide one
replacement copy at no charge, but permit a charge for subsequent
copies. Stuart (Comment #0841).
\258\ Burchell (Comment #0866).
\259\ Comment #0748 submitted by Cutler. The HHS' proposed
modifications to the HIPAA Privacy Rule would clarify that providers
may not charge individuals a fee to inspect their protected health
information in person (including when they photograph or record the
information themselves) or to view and capture an electronic copy of
their information via an internet-based method. Proposed
Modifications to the HIPAA Privacy Rule To Support, and Remove
Barriers to, Coordinated Care and Individual Engagement, 86 FR 6446,
6465-6466.
---------------------------------------------------------------------------

Other commenters, including the AOA and the AAO, opposed amending
the Rule to require that prescribers provide additional copies upon
request.\260\ These commenters stated that most prescribers already
provide additional copies at no charge and, therefore, there is no need
to mandate it by rule.\261\ Some commenters stated that consumers
should be responsible for copying and maintaining their
prescription,\262\ and that prescribers should not have to shoulder the
burden of consumers who are remiss at recordkeeping.\263\ The AOA
expressed concern with the possible health effects to consumers that
could result from requiring prescribers to provide prescriptions long
after an initial refraction, and stated that prescribers must be
allowed to use their clinical judgment to determine whether it is
medically appropriate to provide subsequent copies of a prescription
that may not be recent.\264\ The organization did not detail specific
negative health effects, but stated that there are scenarios wherein an
optometrist may not want to reissue an eyeglass prescription to a
patient. For example, the optometrist may have performed a more recent
comprehensive eye exam that renders the previous prescription no longer
appropriate, or the prescriber may be aware of other health changes for
the patient that could necessitate a change in the prescription.\265\
The AOA also pointed out, as a comparison, that medical doctors are not
required to give patients multiple copies of pharmaceutical
prescriptions upon request and that some medical doctors may require
payment for such additional copies.\266\
---------------------------------------------------------------------------

\260\ See, e.g., AAO (Comment #0864 submitted by Haber); AOA
(Comment #0849 submitted by Peele); Publi (Comment #0040); Haas
(Comment #0359); Sharma (Comment #0609); Berry (Comment #0673).
\261\ AAO (Comment #0864 submitted by Haber); AOA (Comment #0849
submitted by Peele); Sharma (Comment #0609); Berry (Comment #0673).
The AAO stated that if practices are inflexible with regard to
providing duplicate copies, patients will go elsewhere for their eye
care needs. Comment #0864 submitted by Haber. One commenter
indicated that amending the Rule is not necessary because consumers
should have access to their prescriptions through electronic health
records or patient portals. Bolenbaker (Comment #0633).
\262\ Publi (Comment #0040); Haas (Comment #0359).
\263\ See, e.g., Haas (Comment #0359).
\264\ Comment #0849 submitted by Peele.
\265\ Id.
\266\ Id.
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a. Analysis of Whether To Require Provision of Additional Copies of
Prescriptions Upon Request
It is unnecessary to decide whether failure to provide an
additional copy of a prescription upon request is an unfair act or
practice because the Commission has not been presented with, and is
unaware of, evidence that refusing to provide duplicate copies of
prescriptions upon request is a prevalent problem. The NAOO, the AAO,
and the AOA commented that prescribers do provide additional copies of
prescriptions upon request.\267\ The only commenter who asserted that
prescribers are not releasing duplicate copies of prescriptions upon
request was Warby Parker.\268\ In support of its statement that some of
its customers are being denied additional copies of prescriptions,
Warby Parker cited to a survey that it said showed that 30 percent of
consumers were not offered a copy of their prescription.\269\ This
fact, however, may relate to the failure to initially release
prescriptions to consumers, not the provision of additional copies, and
thus does not establish that prescribers are refusing to provide
additional copies to consumers upon request. Since the rulemaking
record does not support a showing of prevalence, which is necessary for
any Eyeglass Rule amendment,\270\ the Commission does not believe it
has sufficient evidence to propose amending the Rule to require that
prescribers provide additional copies of prescriptions upon
request.\271\
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\267\ NAOO (Comment #0748 submitted by Cutler); AAO (Comment
#0864 submitted by Haber); AOA (Comment #0849 submitted by Peele);
see also Sharma (Comment #0609) (stating duplicates already being
provided on voluntary basis); Berry (Comment #0673) (same).
\268\ Comment #0817 submitted by Kumar.
\269\ Id.
\270\ See 15 U.S.C. 57a(b)(3).
\271\ The Commission recognizes that this result differs from
the FCLCA and the CLR, which require prescribers to respond to
requests for additional copies of prescriptions. 15 U.S.C.
7601(a)(2); 16 CFR 315.3(a)(2). See also CLR NPRM, 81 FR 88526,
88536 (explaining Act and Rule's requirements to provide a copy of
an additional contact lens prescription upon request). However, as
previously explained, the authority for the Eyeglass Rule is
different than for the CLR, and requires a showing that the problem
is prevalent.
---------------------------------------------------------------------------

b. Analysis of Whether To Permit Prescribers To Charge Fees for
Provision of Additional Copies of Prescriptions
In addition to not requiring that prescribers provide additional
copies of prescriptions, the Eyeglass Rule does not set forth whether
or not prescribers are permitted to charge for providing such copies.
Some of the commenters requested the Commission amend the Rule to
either permit a prescriber to charge a fee,\272\ or to prohibit a
prescriber from charging a fee,\273\ for providing additional copies.
Since the Commission determined not to propose amending the Rule to
require prescribers provide additional copies, it is unnecessary to
address the issue of fees for mandated duplicate copies.\274\
---------------------------------------------------------------------------

\272\ Kiener (Comment #0593) (proposing a small administrative
fee); Burchell (Comment #0866) (stating administrative charge should
reflect the cost of the paper, other office supplies, and office
staff time; suggesting that current market supports a fee of $2-$10;
and clarifying the fee should not be a profit-making mechanism);
Pulido (Comment #0019) (proposing a small fee).
\273\ NAOO (Comment #0748 submitted by Cutler); Warby Parker
(Comment #0817 submitted by Kumar). One commenter recommended that
the Rule mandate prescribers provide one replacement copy at no
charge, but permit a charge for subsequent copies. Stuart (Comment
#0841).
\274\ As noted above, if the prescriber has failed to provide a
copy of the prescription following the completed examination in
violation of the Rule, the prescriber must provide a copy of the
prescription when a patient later asks for it. Because the
prescriber could not charge a fee had he or she provided it
immediately following the examination, the prescriber may not do so
in response to that patient's later request for an initial copy.
---------------------------------------------------------------------------

In the current Rule review, as noted above, little evidence was
placed on the record indicating that prescribers are not providing
duplicate prescriptions upon request or that prescribers are charging
more than nominal, administrative fees for providing additional copies
of prescriptions. As a result, the Commission has not been presented
with evidence that these practices are prevalent and does not believe
an amendment prohibiting or limiting the imposition of fees for
additional copies of prescriptions is necessary.
2. Electronic Delivery of Prescriptions as a Means for Automatic
Prescription Release Under Sec. 456.2(a)
As previously noted, 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

[[Page 268]]

immediately after the eye examination is completed. The Rule does not
expressly permit electronic delivery of prescriptions as a means for
automatic prescription release. The Commission believes expressly
permitting electronic delivery in certain circumstances could provide
benefits to consumers.
In 2021, the CLR was amended to allow prescribers to satisfy the
CLR's automatic release requirement by providing the patient with a
digital copy of his or her contact lens prescription, such as by text
message, electronic mail, or an online patient portal, 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.\275\ In the CLR SNPRM,
the Commission noted that providing patients with an electronic copy of
their prescription 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.\276\
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\275\ CLR Final Rule, 85 FR 50668, 50717.
\276\ CLR SNPRM, 84 FR 24664, 24668.
---------------------------------------------------------------------------

As discussed above, the Commission is proposing to amend the Rule
to add a Confirmation of Prescription Release requirement.\277\ The
proposed text of the Rule would provide prescribers with four
alternative means of complying with the Confirmation of Prescription
Release requirement. The fourth option states, ``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.'' In order to allow prescribers to meet the Confirmation
of Prescription Release requirement in this way, the Rule must describe
the conditions under which electronic delivery of the prescription will
satisfy the automatic prescription release requirements. The Commission
therefore proposes to define the phrase, ``provide to the patient one
copy,'' which appears in Sec. 456.2(a) and creates the requirement to
automatically release the prescription immediately after the eye
examination is completed.\278\ This new definition expressly permits
electronic delivery in certain circumstances.
---------------------------------------------------------------------------

\277\ See Sections II.A, IV.A.6, supra.
\278\ 16 CFR 456.2(a).
---------------------------------------------------------------------------

a. The Commission's Proposal To Add a Definition to Sec. 456.1 To
Permit Electronic Delivery of the Patient's Prescription
Accordingly, the Commission proposes to modify the Rule by adding a
definition of the term ``provide to the patient one copy.'' The
Commission proposes to require that prescribers provide patients with
either a paper copy of their prescription or, with the patient's
verifiable affirmative consent, a digital copy of the patient's
prescription in lieu of a paper copy. Verifiable affirmative consent
means that a patient must have provided his or her consent to the
prescriber in a way that can be later confirmed, such as through a
signed consent form or an audio recording. The consent must also
identify the specific method or methods of electronic delivery to be
used because it is possible that a patient may prefer one method of
electronic communication, but not others, and the patient should be
able to make an informed choice.
Prescribers would be required to keep a record or evidence of a
patient's affirmative consent for a period of not less than three
years, which would facilitate Commission enforcement efforts to monitor
compliance with the Rule. 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.'' \279\ At any rate, obtaining and storing a record of
patient consent should not take longer than obtaining and storing a
patient's Confirmation of Prescription Release under option (i), (ii),
or (iii), and prescribers choosing to use the fourth option to confirm
prescription release would not need to collect additional information
from the patient beyond the consent to electronic delivery. 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.
---------------------------------------------------------------------------

\279\ CLR Final Rule, 85 FR 50668, 50683.
---------------------------------------------------------------------------

The amended Rule would also require that if the prescription is
provided electronically, it must be in a digital format that can be
accessed, downloaded, and printed by the patient. The Commission
believes 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.
Therefore, the Commission proposes to amend Sec. 456.1 to define
the phrase ``provide to the patient one copy'' to mean giving a patient
a copy of his or her prescription:
(1) On paper; or
(2) In a digital format that can be accessed, downloaded, and
printed by the patient. For a copy provided in a digital format, the
prescriber shall identify to the patient the specific method or methods
of electronic delivery to be used, such as text message, electronic
mail, or an online patient portal, and obtain 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. Such
records or evidence shall be available for inspection by the Federal
Trade Commission, its employees, and its representatives.
The full text of the proposed Rule amendment is located at the end
of this document.
b. Technological Advances That May Improve Prescription Portability
Technological advances--including many spurred by federal and state
health information technology initiatives \280\--have fostered the

[[Page 269]]

proliferation of patient portals, application programming interfaces,
and other developing technologies, through which health care providers
can securely share medical information, such as prescription
information, directly with patients. The increasing number of
prescribers who have adopted various health information technologies to
support patient engagement,\281\ such as patient portals, has made it
possible for prescribers to provide online access to prescriptions.
This, along with the patient's ability to email or otherwise upload
prescription copies to sellers, increases prescription portability.
---------------------------------------------------------------------------

\280\ Numerous federal and state programs have been designed to
foster the development of health information technology and the
electronic processing, storage, and transmission of patients' health
information. For example, under the Health Information Technology
for Economic and Clinical Health Act or HITECH Act of 2009--Title
XIII of Division A and Title IV of Division B of the American
Recovery and Reinvestment Act of 2009--Congress directed the
Medicare and Medicaid programs to make direct payments to eligible
healthcare professionals, hospitals, and certain other healthcare
providers specifically to incentivize the adoption and meaningful
use of electronic health records systems (``EHRs''). American
Recovery and Reinvestment Act of 2009, Public Law 111-5, Division B,
Title IV, Sec. Sec. 4101, 4102, and 4201 (2009) (Medicare
incentives for eligible professionals, Medicare incentives for
hospitals, and Medicaid provider payments, respectively). According
to a 2016 report, more than $30 billion in such incentive payments
were made between 2011 and 2015. U.S. Dep't Health & Human Servs.,
Office of the National Coordinator for Health Information
Technology, Report to Congress, ``Update on the Adoption of Health
Information Technology and Related Efforts to Facilitate the
Electronic Use and Exchange of Health Information'' 17 (2016),
https://www.healthit.gov/sites/default/files/Attachment_1_-_2-26-16_RTC_Health_IT_Progress.pdf. Regarding patient portals in
particular, see, e.g., U.S. Dep't Health & Human Servs., Office of
the National Coordinator for Health Information Technology,
``Patient Engagement Playbook,'' https://www.healthit.gov/playbook/pe/introduction/.
\281\ As of 2015, 78 percent of all physicians had adopted
certified health information technology. U.S. Dep't Health & Human
Servs., Office of the National Coordinator for Health Information
Technology, 2018 Report to Congress, ``Annual Update on the Adoption
of a Nationwide System for the Electronic Use and Exchange of Health
Information'' 8 (2018), https://www.healthit.gov/sites/default/files/page/2018-12/2018-HITECH-report-to-congress.pdf.
---------------------------------------------------------------------------

Available information suggests, however, that the number of
patients accessing EHRs, such as patient portals, remains limited,\282\
and that certain patients, including older patients, are less likely to
use these tools.\283\ Through the 21st Century Cures Act, Congress
authorized HHS to take action to promote the interoperability of health
IT, support the use, exchange, and access of electronic health
information, and limit information blocking.\284\ The Cures Act Final
Rule, promulgated by the Office of the National Coordinator for Health
Information Technology (``ONC''),\285\ requires healthcare providers to
enable patient access to enumerated classes of data in their electronic
health record systems. These data classes include providers' clinical
notes and information on medications,\286\ and may result in consumers
having greater access to their prescription information from their
refractive exam.\287\
---------------------------------------------------------------------------

\282\ As noted in the CLR SNPRM, a survey submitted by 1-800
CONTACTS showed that approximately 30% of patients were offered
access to a portal during their last eye exam and, of those who were
given the option, 29% chose to use the portal. CLR SNPRM, 84 FR
24664, 24668 n.50.
\283\ Heather Landi, ``Who Isn't Using Patient Portals? New
Study Sheds Light on Portal Use,'' Population Health Management
(Dec. 12, 2018), https://www.hcinnovationgroup.com/population-health-management/news/13030963/who-isnt-using-patient-portals-new-study-sheds-light-on-portal-use. See also GAO, Report to
Congressional Requesters, ``Health Information Technology'' 17 (Mar.
2017), https://www.gao.gov/assets/690/683388.pdf (reporting that
only 15 to 30% of patients participating in the Medicare EHR program
in 2015 electronically accessed their health information when it was
made available to them).
\284\ 21st Century Cures Act, Public Law 114-255, Title IV
(2016).''Information blocking'' refers to practices that are likely
to interfere with, prevent, or materially discourage access,
exchange, or use of electronic health information. 42 U.S.C. 300jj-
52.
\285\ ONC, 21st Century Cures Act: Interoperability, Information
Blocking, and the ONC Health IT Certification Program, Final Rule,
85 FR 25642 (May 1, 2020).
\286\ See ONC, HealthIT.gov, ``United States Core Data for
Interoperability (USCDI),'' https://www.healthit.gov/isa/united-states-core-data-interoperability-uscdi.
\287\ ONC has received proposals to include refraction
measurements as a data element in the USCDI. See https://www.healthit.gov/isa/uscdi-data-class/ophthalmic-data.
---------------------------------------------------------------------------

The use of patient portals for presentation of eyeglass
prescriptions to sellers could provide many benefits to consumers--
potentially at low marginal cost to those providers who already
maintain EHRs and patient portals. When using a portal, the patient
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.\288\ The use of health information 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, patient portals may
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.\289\
---------------------------------------------------------------------------

\288\ Empirical studies of the integrity of electronic
transmission of prescription information chiefly focus on systems
for transmitting prescription drug information and not eyeglass
prescriptions. Still, such studies suggest that the adoption of
electronic prescribing greatly reduces the error rate associated
with handwritten paper prescriptions. See, e.g., Rainu Kaushal et
al., ``Electronic Prescribing Improves Medication Safety in
Community-Based Office Practices,'' 25 J. Gen. Intern. Med. 530, 530
(2010) (finding that, ``For e-prescribing adopters, error rates
decreased nearly sevenfold, from 42.5 per 100 prescriptions (95%
confidence interval (``CI''), 36.7-49.3) at baseline to 6.6 per 100
prescriptions (95% CI, 5.1-8.3) one year after adoption (p < 0.001).
For non-adopters, error rates remained high at 37.3 per 100
prescriptions.'').
\289\ See, e.g., ONC, HealthIT.gov, ``Do I Need to Obtain
Consent From My Patients to Implement a Patient Portal?,'' https://www.healthit.gov/faq/do-i-need-obtain-consent-my-patients-implement-patient-portal (noting that HIPAA permits the disclosure of health
information to the patient without requiring the patient's express
consent and that portals are ``an excellent way to afford patients
access to their own information and to encourage them to be active
partners in their health care.'').
---------------------------------------------------------------------------

Accordingly, the Commission believes that the use of health
information technologies, such as patient portals, to provide patients
with access to electronic copies of their eyeglass prescriptions can
benefit prescribers, patients, and sellers. The Commission encourages
prescribers to consider whether, in addition to providing patients with
copies of their prescriptions immediately following the completion of
the eye examination, they should make prescriptions available
electronically and online via health information technologies, in
accordance with federal and state law and HHS guidance. To facilitate
the likelihood that patient portals will increase prescription
portability, prescribers should consider whether to configure patient
portals to allow the patient to download, save, and print the
prescription.\290\ In addition, prescribers should explore whether
designing the portal to allow the patient to securely transmit the
prescription directly to a seller will further foster prescription
portability.
---------------------------------------------------------------------------

\290\ If a prescriber intends to use a patient portal to satisfy
the automatic prescription release requirement of Sec. 456.2(a),
the proposed new definition of the phrase ``provide to the patient
one copy'' would require that the prescription be provided in a
digital format that can be accessed, downloaded, and printed by the
patient.
---------------------------------------------------------------------------

The proposed Rule amendment permitting electronic delivery of
prescriptions to satisfy the automatic prescription release requirement
expressly contemplates the use of patient portals to deliver
prescriptions. Significantly, the proposed change to allow for a
digital copy in lieu of a paper copy does not alter the timing of when
a prescriber must provide the prescription to the patient. In both
instances, whether a digital or paper copy is given, prescribers must
provide the prescription immediately after completion of the refractive
eye examination. The Commission believes increased future use and
adoption of health information technologies, such as patient portals,
in response to the 21st Century Cures Act and other developments, have
the potential to facilitate prescribers' compliance with the automatic
prescription release requirement of the Rule and believe it is
appropriate to provide an option for prescribers to use electronic
delivery of prescriptions, so long as patients have expressly consented
in advance to the mode of delivery used.

[[Page 270]]

c. HIPAA Concerns Regarding Emailed Prescriptions
In response to the ANPR, the Commission did not receive any
comments that identified concerns with how the Eyeglass Rule interacts
with HIPAA and the HIPAA Privacy and Security Rules (``HIPAA
Rules'').\291\ However, in other contexts, the Commission has received
questions and complaints related to prescribers' HIPAA obligations
under the Eyeglass Rule. For example, some prescribers have asked staff
whether HIPAA precludes optometrists from emailing copies of a
prescription to a patient without written authorization.
Correspondingly, some consumers have complained that their eye care
practitioners have cited HIPAA in refusing to email or fax eyeglass
prescriptions to them.
---------------------------------------------------------------------------

\291\ 45 CFR parts 160, 164.
---------------------------------------------------------------------------

As a preliminary matter, the HIPAA Rules do not require the
prescriber to obtain a signed HIPAA authorization from a patient in
order for the prescriber to release an eyeglass prescription to the
patient.\292\ The HIPAA Rules also do not prohibit covered prescribers
from emailing eyeglass prescriptions to patients. According to guidance
provided by HHS, the HIPAA Rules allow health care providers to
communicate electronically with patients, provided they apply
reasonable safeguards.\293\ Although a covered provider must consider
encryption to protect against unintentional disclosures, the provider
may determine that it is not reasonable and appropriate, and may
instead apply ordinary precautions when transmitting unencrypted email,
such as checking the email address for accuracy before sending, sending
an email alert to the intended recipient for address confirmation prior
to sending the message, and limiting the amount and type of protected
health information (``PHI'') transmitted through the email.\294\
---------------------------------------------------------------------------

\292\ See 45 CFR 164.502(a)(1); U.S. Dep't of Health & Human
Servs., Office for Civil Rights, ``Summary of the HIPAA Privacy
Rule'' 4-5 (2003), http://www.hhs.gov/sites/default/files/privacysummary.pdf (``A covered entity is permitted . . . to use and
disclose protected health information, without an individual's
authorization, for the following purposes or situations: (1) To the
Individual (unless required for access or accounting of disclosures)
. . . . Covered entities may rely on professional ethics and best
judgments in deciding which of these permissive uses and disclosures
to make.'') (footnote omitted).
\293\ U.S. Dep't Health & Human Servs., Health Information
Privacy, FAQs, ``Does the HIPAA Privacy Rule permit health care
providers to use email to discuss health issues and treatment with
their patients?,'' http://www.hhs.gov/hipaa/for-professionals/faq/570/does-hipaa-permit-health-care-providers-to-use-email-to-discuss-health-issues-with-patients/; see also 45 CFR 164.530(c).
\294\ Encryption of PHI must be implemented where a covered
entity has determined that it is a reasonable and appropriate
safeguard as part of its risk management. See U.S. Dep't Health &
Human Servs., Health Information Privacy, FAQs, ``Is the use of
encryption mandatory in the Security Rule?,'' http://www.hhs.gov/hipaa/for-professionals/faq/2001/is-the-use-of-encryption-mandatory-in-the-security-rule/index.html. A covered health care provider also
must protect PHI in those emails while they are stored on servers,
workstations, mobile devices, and other computer systems, through
encryption and other safeguards, as appropriate. See 45 CFR
164.306(a).
---------------------------------------------------------------------------

Moreover, where a patient requests that the covered entity transmit
PHI (such as a copy of an eyeglass prescription) by unencrypted email--
as is their right under the HIPAA Privacy Rule right of access--a
covered entity must do so,\295\ even if the email is an unsecure mode
of transmission.\296\ Before sending unencrypted email containing PHI
to a patient, the entity must advise the patient of the risk that the
unencrypted PHI could be intercepted and accessed by unauthorized third
parties.\297\ If, after having been advised of the risks, the patient
still opts to receive his or her PHI via unencrypted email, the patient
has the right to receive the PHI in that manner, and the covered entity
is not liable for unauthorized access to the PHI during electronic
transmission, or for safeguarding the PHI once delivered to the
patient.\298\ Conversely, a covered prescriber must honor a patient's
reasonable request that the prescriber not send communications via
unencrypted email, by offering other means of delivery, such as
encrypted email, secure patient portal, postal mail, or telephone.\299\
---------------------------------------------------------------------------

\295\ The HIPAA Privacy Rule right of access requires a covered
prescriber to provide, upon patient request, a copy of a
prescription to the patient or to another person or entity she
designates. 45 CFR 164.524(c)(3); see also U.S. Dep't Health & Human
Servs., Health Information Privacy, FAQs, ``Individuals' Right under
HIPAA to Access their Health Information 45 CFR 164.524,'' http://www.hhs.gov/hipaa/for-professionals/privacy/guidance/access/. HHS
has proposed modifying the Privacy Rule to clarify that an
individual's right of access to direct a provider to transmit PHI to
a third party is limited to an electronic copy of PHI contained in
an electronic health record. Proposed Modifications to the HIPAA
Privacy Rule To Support, and Remove Barriers to, Coordinated Care
and Individual Engagement, 86 FR 6446, 6462.
\296\ U.S. Dep't Health & Human Servs., Health Information
Privacy, FAQs, ``Do individuals have the right under HIPAA to have
copies of their PHI transferred or transmitted to them in the manner
they request, even if the requested mode of transfer or transmission
is unsecure?,'' https://www.hhs.gov/hipaa/for-professionals/faq/2060/do-individuals-have-the-right-under-hipaa-to-have/index.html
(``individuals generally have a right to receive copies of their PHI
by mail or email, if they request. It is expected that all covered
entities have the capability to transmit PHI by mail or email and
transmitting PHI in such a manner does not present unacceptable
security risks to the systems of covered entities, even though there
may be security risks to the PHI once it has left the systems. Thus,
a covered entity may not require that an individual travel to the
covered entity's physical location to pick up a copy of her PHI if
the individual requests the copy be mailed or emailed.'')
\297\ Modifications to the HIPAA Privacy, Security, Enforcement,
and Breach Notification Rules Under the Health Information
Technology for Economic and Clinical Health Act and the Genetic
Information Nondiscrimination Act; Other Modifications to the HIPAA
Rules, 78 FR 5565, 5634 (Jan. 25, 2013).
\298\ Id.
\299\ 45 CFR 164.522(b).
---------------------------------------------------------------------------

While permitting electronic delivery with a patient's verifiable
consent, the proposed Rule amendment would not mandate that prescribers
use electronic delivery, nor would it obligate patients to accept such
delivery.\300\ As with the recent CLR amendment,\301\ patients who
decline to consent to electronic delivery, for any reason, must be
given a paper copy of their prescription. Likewise, because technology
is still developing or may be costly to implement, prescribers who
prefer to provide paper copies to their patients would not be required
to offer an electronic option under the amended Rule.
---------------------------------------------------------------------------

\300\ The proposed amendment would also not alter or pre-empt
existing state and federal requirements pertaining to the electronic
delivery of records and consumer consent, such as the Electronic
Signatures in Global and National Commerce Act, 15 U.S.C. 7001 (``E-
Sign'').
\301\ See CLR Final Rule, 85 FR 50668, 50682.
---------------------------------------------------------------------------

3. Insurance Coverage as Payment Under Sec. 456.2(a)
The Eyeglass Rule requires that prescribers provide consumers with
a copy of their prescription, but also contains an 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.\302\ The
CLR contains the same provision, but also provides that for purposes of
this exception, a patient's proof of insurance coverage shall be deemed
to constitute a payment.\303\ The Eyeglass Rule does not contain this
insurance clarification, and staff has received questions from the
public about this issue. The Commission believes that such a proviso,
which was initially formulated by Congress in drafting the FCLCA,\304\
should be added to the Eyeglass Rule, both because it is appropriate
that a patient's proof of

[[Page 271]]

insurance coverage equates to payment, and to bring the two rules into
conformity, to eliminate unnecessary confusion. The Commission thereby
proposes a technical amendment to the Rule to add a statement to the
end of Sec. 456.2(a) clarifying that the presentation of proof of
insurance coverage shall be deemed to be a payment.
---------------------------------------------------------------------------

\302\ 16 CFR 456.2(a).
\303\ 16 CFR 315.4.
\304\ 15 U.S.C. 7602.
---------------------------------------------------------------------------

C. Requiring Prescribers To Respond to Authorized Third-Party Seller
Requests for a Copy of Prescription or Verification of Prescription
Information

In contrast to the CLR, the Eyeglass Rule does not require a
prescriber to provide a copy to, or verify prescription information
with, third-party sellers authorized by the patient.\305\ The
Commission requested comment on whether it should amend the Rule to
obligate prescribers to respond to either or both of these requests
from sellers.\306\
---------------------------------------------------------------------------

\305\ The Eyeglass Rule contains the word ``verification,'' but
the meaning associated with that word is quite different from what
is being considered in this discussion. Section 452.6(c) states that
a prescriber may not charge a patient any fee in addition to the
examination fee as a condition of releasing the prescription, but
provides a caveat that the prescriber ``may charge an additional fee
for verifying ophthalmic goods dispensed by another seller when the
additional fee is imposed at the time the verification is
performed.'' Verification in the exception pertains to an
ophthalmologist or optometrist examining the accuracy of the lenses
dispensed by another seller, and not a prescriber verifying
prescription information provided by a seller. See Eyeglass I Rule,
43 FR 23992, 23998.
\306\ See Eyeglass Rule ANPR, 80 FR 53274, 53276.
---------------------------------------------------------------------------

1. Comments on Requiring Prescriber Response to Third-Party Seller
Requests
Some commenters recommended that the Commission align the Eyeglass
Rule with the CLR, which requires that prescribers provide authorized
third parties with a copy of, and verification of, a prescription.\307\
Under the CLR, a seller may only sell contact lenses in accordance with
a prescription that is presented to the seller by the patient or
prescriber, or verified by the prescriber.\308\ A prescription is
verified only if the prescriber confirms the prescription is accurate,
the prescriber informs the seller that the prescription is inaccurate
and provides the accurate prescription, or the prescriber fails to
respond to the seller within eight business hours after receiving a
complete verification request (``passive verification'').\309\ A
prescriber is also required to respond to an authorized seller's
request for a copy of a prescription.\310\
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\307\ See, e.g., NAOO (Comment #0748 submitted by Cutler); Warby
Parker (Comment #0817 submitted by Kumar); Duplantier (Comment
#0847); Opternative (now Visibly) (Comment #0853 submitted by
Dallek).
\308\ 16 CFR 315.5.
\309\ Id.
\310\ 16 CFR 315.3(a).
---------------------------------------------------------------------------

The verification requirements for contact lenses derive from the
FCLCA, which created the framework for contact lens sales and directed
the Commission to promulgate the CLR.\311\ The FCLCA requires that
sales of contact lenses occur only with a copy of a prescription, or
after verifying a prescription with a prescriber, and sets forth the
requirements for passive verification.\312\
---------------------------------------------------------------------------

\311\ 15 U.S.C. 7607; 16 CFR 315.1.
\312\ 15 U.S.C. 7603.
---------------------------------------------------------------------------

Commenters in favor of amending the Eyeglass Rule to require that
prescribers provide copies of prescriptions to sellers, or verify
prescriptions with sellers, include the NAOO, several state optician
groups and individual opticians, some prescribers (including a
telehealth prescriber), eyewear seller Warby Parker and some of its
employees, a United States Senator, and numerous individual
consumers.\313\ Warby Parker and a number of consumers stated that
there is a need for such a requirement because, at present, when
sellers request a copy or verification of prescription information,
prescribers do not always respond \314\ or respond in a timely
fashion.\315\ Warby Parker commented that it expends substantial
resources ``persuad[ing prescribers] to provide the information
required to fill a consumer order,'' and that it informs between 50 and
100 consumers per day that it is unable to complete their eyeglass
orders.\316\ As a result, some consumers complained that they waited a
long time for their eyeglasses, or that they were ultimately unable to
purchase glasses from a seller other than their prescriber.\317\ Some
of these commenters felt that prescribers have unfairly kept their
medical information from them.\318\
---------------------------------------------------------------------------

\313\ See, e.g., Opticians Association of America (Comment #0638
submitted by Allen); Opticians Alliance of New York (Comment #0642
submitted by Cullen); Duff (Comment #0653); NAOO (Comment #0748
submitted by Cutler); South Carolina Association of Opticians
(Comment #0822 submitted by Harbert); DeMuth Jr. (Comment #0055);
Senate Majority Leader Charles Schumer (Comment #0865); Ramiah
(Comment #0139); Capurso (Comment #0149); Mendelsohn (Comment
#0429); Groenke (Comment #0697); Schrup (Comment #0765); Kuhl
(Comment #0766); Gorsuch (Comment #0773); Frein (Comment #0774);
Hopkins (Comment #0776); Feldman (Comment #0780); Anderson (Comment
#0781); Lyden (Comment #0792); Jackson (Comment #0707); Meinke
(Comment #0795); Lorenczi (Comment #0796); Keas (Comment #0798);
Burkhart (Comment #0805); Albee (Comment #0806); Rivera (Comment
#0809); Warby Parker (Comment #0817 submitted by Kumar); Warden
(Comment #0820); Anderson (Comment #0714); Sansbury (Comment #0825);
Williamson (Comment #0827); Ardis (Comment #0830); Folline Vision
Centers (Comment #0837); Rump (Comment #0843); Murtha (Comment
#0844); Heaton (Comment #0845); Gage-Halman (Comment #0846);
Malonjao (Comment #0856). Some commenters used the term ``verify''
to mean that prescribers should be required to provide a copy of a
prescription to an optical shop. See, e.g., Debnam (Comment #0039)
(consumer did not have a copy of the prescription so asked optical
shop to call the doctor to verify the prescription); Panaccio
(Comment #0340) (same). In other instances, it was unclear whether
commenters were discussing requiring the prescriber to provide a
copy of, or verify, prescriptions.
\314\ See, e.g., Debnam (Comment #0039); White (Comment #0053);
Kidwell (Comment #0054); Averett (Comment #0057); Silva-Sadder
(Comment #0065); Tresham (Comment #0737); Kulp (Comment #0150); Lass
(Comment #0197); Moran (Comment #0202); Vieira (Comment #0237);
Lavieri (Comment #0242); Panaccio (Comment #0340); Schermerhorn-
Cousens (Comment #0350); Stout (Comment #0527); Warby Parker
(Comment #0817 submitted by Kumar).
\315\ See, e.g., Peel (Comment #0281); Paluzzi (Comment #0412);
Quinn (Comment #0427); Hollis (Comment #0430); Choi (Comment #0455);
Cash (Comment #0482); Gold (Comment #0503); Poppy (Comment #0517);
Schneider (Comment #0571); Crollini (Comment #0607); Pappas (Comment
#0692); Peaton (Comment #0772); Benson (Comment #0777); Carter
(Comment #0778); Ghaznavi (Comment #0779); Knittel (Comment #0782);
Cornett (Comment #0784); Nakanishi (Comment #0789); Anderson
(Comment #0797); Beeferman (Comment #0801); Taylor (Comment #0787);
Todd (Comment #0802); Kelley (Comment #0804); Nguyen (Comment
#0812); Necastro (Comment #0816); Warby Parker (Comment #0817
submitted by Kumar); Stauffer (Comment #0859).
\316\ Comment #0817 submitted by Kumar.
\317\ Debnam (Comment #0039); White (Comment #0053); Kidwell
(Comment #0054); Averett (Comment #0057); Tresham (Comment #0075);
Ramiah (Comment #0139); Boyle (Comment #0605).
\318\ Debnam (Comment #0039); White (Comment #0053); Kidwell
(Comment #0054); Averett (Comment #0057); Silva-Sadder (Comment
#0065); Tresham (Comment #0075); Kulp (Comment #0150); Lass (Comment
#0197); Moran (Comment #0202); Vieira (Comment #0237); Lavieri
(Comment #0242); Panaccio (Comment #0340); Schermerhorn-Cousens
(Comment #0350); Stout (Comment #0527); see also Magida (Comment
#0597) (complaining that it felt like the prescriber held
prescription ransom because consumer was looking elsewhere to
purchase eyeglasses).
---------------------------------------------------------------------------

In addition to those comments recommending that the Commission
require sellers to obtain a copy of, or verify, a prescription before
manufacturing eyeglasses,\319\ one commenter opined that a verification
provision would promote fair competition and better options and pricing
for consumers; \320\ and others supported rule improvements that would
increase access to safe, affordable prescription eyewear.\321\ U.S.
Senator Charles Schumer commented that not having a verification
requirement limits consumer choice and leads to higher prices.\322\ In
addition, state opticians

[[Page 272]]

groups, individual opticians, and at least one optometrist, stated that
enabling sellers to verify prescriptions with a patient's optometrist
or ophthalmologist would better ensure patient safety.\323\
---------------------------------------------------------------------------

\319\ See note 122, supra.
\320\ Mendelsohn (Comment #0429).
\321\ O'Dea (Comment #0188); Buntain (Comment #0531).
\322\ Comment #0865. Warby Parker made similar arguments
regarding consumers' need for easy access to affordable prescription
glasses. Comment #0817 submitted by Kumar. According to Warby
Parker, its sales model reduces the cost of eyeglasses dramatically,
offering a savings of approximately 75 percent as compared to
prescription eyeglasses sold in traditional retail stores. The
company indicated that it sells prescription eyeglasses starting at
$95, and that consumers will often pay $400 or more elsewhere for
eyeglasses of comparable quality. Id. Industry statistics show that,
as of late 2015, online sellers were typically 50 to 60 percent less
expensive than brick and mortar locations. See Vision Council,
``U.S. Optical Overview and Outlook,'' supra note 71, at 65 n.3.
\323\ Opticians Association of America (Comment #0638 submitted
by Allen); Opticians Alliance of New York (Comment #0642 submitted
by Cullen); Duff (Comment #0653); South Carolina Association of
Opticians (Comment #0822 submitted by Harbert); Groenke (Comment
#0697); Schrup (Comment #0765); Kuhl (Comment #0766); Gorsuch
(Comment #0773); Frein (Comment #0774); Hopkins (Comment #0776);
Feldman (Comment #0780); Anderson (Comment #0781); Lyden (Comment
#0792); Jackson (Comment #0707); Meinke (Comment #0795); Lorenczi
(Comment #0796); Keas (Comment #0798); Burkhart (Comment #0805);
Albee (Comment #0806); Rivera (Comment #0809); Warden (Comment
#0820); Anderson (Comment #0821); Sansbury (Comment #0825);
Williamson (Comment #0827); Ardis (Comment #0830); Folline Vision
Centers (Comment #0837); Rump (Comment #0843); Murtha (Comment
#0844); Heaton (Comment #0845); Gage-Halman (Comment #0846);
Malonjao (Comment #0856); see also Jozwik (Comment #0002)
(commenting that verification minimizes mistakes since the
information is straight from the prescriber).
---------------------------------------------------------------------------

The NAOO and Warby Parker specifically requested the Rule be
amended to include ``passive verification,'' similar to that in the
CLR, which would allow the sale of eyeglasses after a seller requests
prescription verification and the prescriber fails to respond within a
certain period of time.\324\ In support, the NAOO stated that there is
only a very small health or safety risk, if any, in improper fitting or
inaccurate prescriptions for corrective eyewear, and such risk is
substantially less for eyeglasses than contact lenses (since eyeglasses
are not placed on the eye itself).\325\
---------------------------------------------------------------------------

\324\ NAOO (Comment #0748 submitted by Cutler); Warby Parker
(Comment #0817 submitted by Kumar). Mandating passive verification
may make it easier and faster for those consumers who have an
expired or unsigned eyeglass prescription, or who have their
specifications read from their current pair. However, passive
verification would not benefit consumers who do not have anything to
refer to containing their eyeglass specifications.
\325\ Comment #0748 submitted by Cutler. The group also stated
that the absence of any pattern of consumer health problems
following more than ten years of the Contact Lens Rule's ``passive
verification'' approach demonstrates that the ``FTC would be
justified in addressing prescriber unwillingness to verify eyeglass
prescriptions by taking the same approach in the Eyeglass Rule.''
---------------------------------------------------------------------------

On the other hand, several commenters, mostly prescribers, objected
to amending the Rule to require prescribers to respond to sellers'
requests for prescription information.\326\ The AOA did not comment on
whether prescribers should be required to provide a copy of a
prescription to third-party sellers,\327\ but ``strongly oppose[d]''
adding a verification process similar to that utilized under the CLR,
stating that the CLR's passive verification process had various
``problems and weaknesses.'' \328\ Another prescriber indicated that a
verification requirement would waste a prescriber's time since the
customer already receives a copy of the prescription.\329\ The AAO
recognized in its comment that the expansion of online eyeglass vendors
has led to a growing need for third-party verification, but stated that
ophthalmic practitioners have worked diligently to meet that need
without the Eyeglass Rule mandating it.\330\ The AAO also contended
that, due to the larger volume of eyeglass prescriptions as compared to
contact lens prescriptions, amending the Rule to require strict
timeframes for prescribers to respond to verification requests would
pose undue financial burden on prescribers.\331\
---------------------------------------------------------------------------

\326\ Publi (Comment #0040); Gupta (Comment #0446); Cerri
(Comment #0509); Kiener (Comment #0593); Bolenbaker (Comment #0633);
Smith (Comment #0652); Geist (Comment #0679).
\327\ However, as noted in Section IV.B.1 above, the
Commission's request for comment on whether prescribers should be
required to provide duplicate copies upon request, the AOA responded
that prescribers must be allowed to use their clinical judgment to
determine whether it is appropriate to provide additional copies
long after the refraction was performed. Comment #0849 submitted by
Peele.
\328\ In its Eyeglass Rule comment, the AOA did not specify what
these problems and weaknesses are. Comment #0849 submitted by Peele.
However, in its comment submitted pursuant to the Contact Lens Rule
review, the AOA raised concerns about, among other things, automated
robocall verifications, and sellers' lack of live contact persons
available to respond to prescriber verification questions and
concerns. CLR RFC Comment FTC-2015-0093-0623 submitted by Peele. In
addition, the AOA has questioned the Commission's legal authority to
add a verification requirement to the Eyeglass Rule without a
congressional act authorizing it to do so. Comment #0849 submitted
by Peele. In this NPRM and in the Rule review more generally, the
Commission analyzes whether it meets the requisite section 18
factors before recommending any changes.
\329\ Gupta (Comment #0446); see also Publi (Comment #0040)
(consumer against verification requirement stating consumers already
have their prescriptions).
\330\ Comment #0864 submitted by Haber. The AAO stated that if
practitioners are inflexible with regard to providing duplicate
copies or verifying prescriptions, patients will go elsewhere for
their eye care needs. See also NAOO (Comment #0748 submitted by
Cutler) (stating most of its members honor requests to verify
eyeglass prescriptions at no charge, but recognizing most members do
not dispense eyeglasses, and therefore, have less monetary incentive
to ignore or decline such requests).
\331\ Comment #0864 submitted by Haber. There are approximately
165 million eyeglass wearers compared to about 45 million contact
lens wearers. See VisionWatch Report, supra note 70, at 24 (165.4
million eyeglass wearers; 42.4 million contact lens wearers);
Centers for Disease Control and Prevention, Contact Lenses: Fast
Facts (July 26, 2018), https://www.cdc.gov/contactlenses/fast-facts.html (an estimated 45 million contact lens wearers in the
U.S.). Although more individuals in the United States wear
eyeglasses than contact lenses, many consumers do not order a new
pair of eyeglasses every year. In fact, in 2019, consumers purchased
approximately 79 million pairs of eyeglass frames and 88 million
pairs of lenses, whereas nearly 103 million contact lens units were
sold in the same period. See VisionWatch Report, supra note 70, at
12, 82. Further, many contact lens wearers make more than one order
in a year. ``The Strength of Competition in the Sale of Rx Contact
Lenses: An FTC Study,'' 45-46 n.18 (2005), https://www.ftc.gov/sites/default/files/documents/reports/strength-competition-sale-rx-contact-lenses-ftc-study/050214contactlensrpt.pdf (finding that just
12-20 percent of consumers purchase a year's supply at a time). As a
result, the burden of responding to requests for a copy of, or
verification of, eyeglass prescriptions is not necessarily greater
than that for contact lens prescriptions.
---------------------------------------------------------------------------

2. Analysis of Whether To Amend the Rule To Require Prescriber Response
The Commission declines to propose to amend the Rule to require
that prescribers respond to third-party requests for prescriptions or
the verification of prescription information. The Commission bases this
decision on a number of factors. Initially, the Commission notes that
the evidence regarding this issue is primarily anecdotal and the
Commission does not, at present, have adequate data as to the number of
such third-party requests, nor the percentage of requests that
prescribers decline to fulfill. Furthermore, according to comments from
the AAO and the AOA, many prescribers are complying with patient
requests for duplicate copies of their prescription, even without such
conduct being mandated by the Eyeglass Rule.\332\ This may be because
prescribers are required to respond to patient requests for their
prescription under HIPAA's right of access to medical records and many
state laws.\333\
---------------------------------------------------------------------------

\332\ AAO (Comment #0864 submitted by Haber) (duplicate copies
traditionally provided at no charge); AOA (Comment #0849 submitted
by Peele) (calling provision of duplicate copies common practice
among optometrists); Haas (Comment #0359); Sharma (Comment #0609);
Berry (Comment #0673).
\333\ 45 CFR 164.524(c). Although in order to exercise this
right, consumers may have to file a formal HIPAA request and wait
several days. See note 252, supra. Consumers in most states have a
separate right of access to their medical records, including
prescriptions, under state law. See Health Information and the Law,
Individual Access to Medical Records: 50 State Comparison, http://www.healthinfolaw.org/comparative-analysis/individual-access-medical-records-50-state-comparison (compiling and explaining state
laws that give consumers the right to access their medical records).

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[[Page 273]]

Moreover, the Commission has proposed a requirement for prescribers
to obtain a signed confirmation from patients that they received a copy
of their prescription. It is the Commission's belief that this proposal
will remind prescribers to release prescriptions and increase
compliance with the automatic release provision of the Rule,\334\
resulting in more patients in possession of their prescription, and,
consequently, less need for third-party verification. The signed
confirmation proposal, in conjunction with consumers' ability to access
an additional copy of their prescription through HIPAA, other laws, or
voluntary release by prescribers, should ensure that the vast majority
of consumers have a prescription in hand. With that prescription,
consumers should experience greater convenience and flexibility,
including increased choice of style and service, and lower costs.
---------------------------------------------------------------------------

\334\ See Section IV.A.6, supra.
---------------------------------------------------------------------------

The Commission's goal in adopting the Confirmation of Prescription
Release requirement is to further the purpose of the Rule: to enable
consumers to comparison-shop for eyeglasses. The Commission is mindful
that, at present, a significant percentage of prescribers do not
automatically provide a prescription, and many consumers cannot
reasonably avoid the resulting injury.\335\ The Commission is hopeful
that compliance will improve without adding a requirement that
prescribers provide prescriptions to, or verify prescriptions with,
third parties.\336\ The Commission therefore believes it is unnecessary
at this time to impose possible additional costs upon prescribers that
might arise from mandating they respond directly to third-party
sellers' requests,\337\ but may revisit this issue in the future if we
receive additional information.
---------------------------------------------------------------------------

\335\ See Section IV.A.4, supra.
\336\ The Commission is not indicating that prescribers should
ignore such requests, but rather is declining to propose to amend
the Rule to mandate such a response.
\337\ Several commenters pointed out that there is a burden
associated with requiring prescribers to respond to requests for a
copy of, or to verify a third-party seller's request for, a
prescription, though they do not agree on how large the burden is.
NAOO (Comment #0748 submitted by Cutler) (declaring that the overall
burden would be trivial when compared to the benefits); Kiener
(Comment #0593) (processing third-party requests poses a not
insignificant operating expense); Opternative (now Visibly) (Comment
#0853 submitted by Dallek) (stating its willingness to take on the
burden for the benefit of greater consumer choice). Although the AOA
did not address the burden of verification in its comment to the
Eyeglass Rule, its comments during the CLR review raised concerns
about the burden presented from the CLR's verification requirement.
CLR RFC Comment FTC-2015-0093-0623 submitted by Peele.
---------------------------------------------------------------------------

V. Prescription Requirements

A. Requiring Prescribers To Include Pupillary Distance on Eyeglass
Prescriptions

The Commission's ANPR sought feedback on whether the Commission
should amend the Rule's definition of prescription to require that
prescribers provide pupillary distance on a prescription.\338\
Pupillary distance is the measurement (in millimeters) of the distance
between the pupils of one's eyes and is a measurement needed to
properly fit a pair of eyeglasses.\339\ Unlike a patient's refraction
dimensions (sphere, cylinder, etc.), pupillary distance remains
relatively constant for adults over time, although it can change a
small amount.\340\ According to prescriber and optician comments,
providing a consumer with an accurate pupillary distance is important
to the health of the patient,\341\ as wearing eyeglasses made based on
an inaccurate measurement can lead to visual discomfort,\342\
headaches,\343\ or even vision loss for some children.\344\
---------------------------------------------------------------------------

\338\ Eyeglass Rule ANPR, 80 FR 53274, 53276.
\339\ See ACLens ``Measuring Pupillary Distance (PD),'' https://www.aclens.com/measuring-pupillary-distance. As discussed later in
this section, some commenters explained that a pupillary distance
measurement is more complex than this definition suggests.
\340\ NAOO (Comment #0748 submitted by Cutler); see also Barry
Santini, ``The Power and Politics of the PD,'' 20/20 Magazine (Mar.
2014), http://www.2020mag.com/l-and-t/46893/ [hereinafter Santini
article] (explaining that the average change in pupillary distance
is three percent between the ages of 18 and 50, and changes even
more slowly after the age of 60).
\341\ See, e.g., Opticians Association of America (Comment #0638
submitted by Allen); Opticians Association of Kentucky (Comment
#0640 submitted by Castle); Opticians Association of Vermont
(Comment #0641 submitted by Williams); Opticians Alliance of New
York (Comment #0642 submitted by Cullen); South Carolina Association
of Opticians (Comment #0822 submitted by Harbert); Robinson (Comment
#0643); Duff (Comment #0653); Johnson (Comment #0654); Thetford
(Comment #0659); Crabtree (Comment #0666); Groenke (Comment #0697).
\342\ Several commenters also pointed out that an accurate
pupillary distance is even more important for those consumers who
have higher-powered prescriptions. See, e.g., Opticians Association
of Alaska, Inc. (Comment #0852 submitted by Brand); Heuer (Comment
#0670); LensCrafters (Comment #0819 submitted by Tavel).
\343\ Clark (Comment #0855).
\344\ Opticians Association of Alaska, Inc. (Comment #0852
submitted by Brand) (incorrect pupillary distance for child with
amblyopia (commonly known as ``lazy eye'') could lead to further
vision loss and impairment); Peaslee (Comment #0700) (an incorrect
pupillary distance could permanently damage a child's vision).
---------------------------------------------------------------------------

Under the Rule, a prescription is defined 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.'' \345\ 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.'' \346\ The
purpose of the Rule's ``prescription'' definition is to effectuate the
separation of the exam and the sale of eyeglasses; it is not intended
to preempt state regulations that determine what must be included in a
prescription.\347\ A review of current state laws demonstrates that
only four states require the inclusion of pupillary distance in a
prescription.\348\
---------------------------------------------------------------------------

\345\ 16 CFR 456.1(g).
\346\ 16 CFR 456.1(b).
\347\ See 16 CFR 456.1(g).
\348\ Alaska Admin. Code tit. 12, Sec. 48.920; Kan. Admin.
Regs. Sec. 65-8-4; 246 Mass. Code Regs. Sec. 3.02; N.M. Stat. Ann.
Sec. 61-2-10.3. Arizona once required pupillary distance on
prescriptions, but that requirement was removed. Ariz. Admin. Code
Sec. R4-21-306 (amended by final rulemaking at 22 Ariz. Admin. Reg.
328, eff. Mar. 28, 2016).
---------------------------------------------------------------------------

Prior to the Rule's initial issuance, the Commission considered
whether to require that prescriptions contain pupillary distance. After
considering the various comments concerning whether pupillary distance
and other measurements needed to make eyeglasses were part of the eye
examination or the dispensing of eyeglasses, and whether prescribers or
opticians were more qualified to take pupillary distance measurements,
it left to the states the determination of whether a pupillary distance
measurement was required prescription information.\349\
---------------------------------------------------------------------------

\349\ Eyeglass I Report, supra note 6, at 255-59.
---------------------------------------------------------------------------

The manner of purchasing eyeglasses when the Commission first
promulgated the Rule differed greatly from the present, however. Then,
if a prescriber did not provide pupillary distance on prescriptions,
consumers could generally obtain that measurement at the brick and
mortar business where they purchased their eyeglasses. Today, consumers
also have the option to purchase their eyeglasses online and need that
measurement to place their order. Several commenters to this Rule
review suggested that the Rule should now be amended to require that
prescriptions include a patient's pupillary distance.\350\
---------------------------------------------------------------------------

\350\ See note 357, infra.
---------------------------------------------------------------------------

Understanding what currently occurs in the marketplace with respect
to

[[Page 274]]

pupillary distance informs the Commission's discussion and analysis.
Some prescribers who measure pupillary distance provide it on
prescriptions automatically; others provide it free upon request or for
a nominal fee, while others refuse to provide it to consumers.\351\
Other prescribers do not ordinarily take pupillary distance, leaving
that task to the optical dispensary that crafts a patient's eyeglasses.
Some prescribers, particularly some ophthalmologists, commented that
they do not have equipment to measure pupillary distance.\352\
---------------------------------------------------------------------------

\351\ NAOO (Comment #0748 submitted by Cutler); see also
Fainzilberg (Comment #0051) (prescriber did not initially provide
pupillary distance and later refused to give the measurement out
over the phone); Wintermute (Comment #0067) (prescriber refused to
provide pupillary distance measurement); Riding (Comment #0100)
(prescriber gave consumer the ``runaround'' and provided the
pupillary distance measurement a couple weeks after the request);
Morris (Comment #0104) (prescriber did not provide the pupillary
measurement on the prescription); Bray (Comment #0105) (same);
Parazette-Nascimbene (Comment #0106) (same); Twardowski (Comment
#0110) (same). The FTC has received complaints from consumers
stating that their prescription did not include, or that their
prescriber refused to provide them with, their pupillary distance.
Other consumer complaints received by the FTC indicate that
consumers have been charged by prescribers between $15 and $40 for a
pupillary distance measurement.
\352\ See, e.g., Narula (Comment #0578); Hoffman (Comment
#0587); Groenke (Comment #0697) (requirement would possibly mean
prescribers would need to purchase expensive equipment); Hopkins
(Comment #0776) (same); LensCrafters (Comment #0819 submitted by
Tavel) (stating that the digital technology required to accurately
obtain these measurements does not typically exist in the doctor's
space); Alvarez (Comment #0838).
---------------------------------------------------------------------------

Consumers who do not receive their pupillary distance on their
prescription, and desire to purchase their eyeglasses online, are able
to obtain that measurement in other ways, though it may cost them time,
money, or, according to some commenters, accuracy. If the information
is in a patient's medical file, the individual may obtain it by filing
a HIPAA request, a process that may require filling out a form, paying
a fee, and waiting up to 30 days.\353\ Consumers may also obtain their
pupillary distance measurements by visiting a third-party brick and
mortar store. Consumers may have to pay for this measurement, although
at least one online seller has offered to reimburse consumers up to a
certain dollar amount for the measurement. Online sellers also offer
directions and online tools for consumers to measure their own
pupillary distance, or to have someone they know measure their
pupillary distance.\354\ Techniques suggested vary from using a credit
card and webcam to using a millimeter ruler and a mirror.\355\ However,
some consumers reported problems with their vision when using
eyeglasses made with pupillary distances they measured themselves using
online tools.\356\ It should be also pointed out that commenters did
not opine on, and the Commission has not analyzed, whether the various
methods consumers may use to determine their pupillary distance, or
whether sellers manufacturing eyeglasses in accordance with self-
measured pupillary distances, are permitted in all jurisdictions.
---------------------------------------------------------------------------

\353\ 45 CFR parts 160, 164 (HHS has proposed reducing this time
to require access be provided ``as soon as practicable,'' but in no
case later than 15 days. See note 252, supra). One complication with
filing a HIPAA request, however, is that a consumer may not know
whether a pupillary distance measurement is in their doctor's
medical file, and might not be able to find out until receiving the
records. Some consumers, though, may already possess a previous
prescription containing their pupillary distance.
\354\ See, e.g., Zenni Optical, ``How to Measure Your Pupillary
Distance (PD),'' http://www.zennioptical.com/measuring-pd-infographic; Warby Parker, ``Measure your pupillary distance (PD),''
https://www.warbyparker.com/pd/instructions.
\355\ Id.
\356\ See note 362, infra.
---------------------------------------------------------------------------

3. Comments on Whether To Require Pupillary Distance
Comments in favor of requiring that prescriptions contain pupillary
distance were primarily from consumers, Warby Parker, and Warby Parker
employees.\357\ These commenters declared that the Rule should include
pupillary distance to increase prescription portability and, therefore,
the procompetitive effects of the Rule.\358\ Warby Parker and consumers
recounted numerous instances where they felt prescribers had engaged in
anti-competitive behavior by refusing to provide, or by charging for,
the measurement.\359\ Warby Parker also alleged that prescribers refuse
to give this measurement as a tactic to keep business because they know
that consumers who request this measurement are taking their eyeglass
business online.\360\ Some consumers stated that they had to obtain
their pupillary distance from another brick and mortar store before
buying online, making it far less convenient to obtain new
eyeglasses.\361\ Some consumers said that they measured their pupillary
distance themselves, but as a result experienced problems with their
glasses.\362\ The NAOO commented that self-estimating pupillary
distance can result in lower accuracy and a higher number of eyeglass
remakes, but that many online sellers have developed accurate
alternative ways to measure pupillary distance.\363\
---------------------------------------------------------------------------

\357\ See, e.g., Fainzilberg (Comment #0051); Wintermute
(Comment #0067); Dingley (Comment #0062); DeLisle (Comment #0070;
Twardowski (Comment #0110); Ramiah (Comment #0139); Cooney (Comment
#0159); Dickens (Comment #0176); O'Dea (Comment #0188); Bailer
(Comment #0191); Wieczorkowski (Comment #0210); Mackey (Comment
#0739); Washington (Comment #0320); Beaudoin (Comment #0349); Myers
(Comment #0351); Montgomery (Comment #0375); Greco (Comment #0406);
Warby Parker (Comment #0817 submitted by Kumar); Cornwell (Comment
#0829). But see Santini (Comment #0047) (optician in favor of adding
a pupillary distance requirement to the Rule); 1-800 CONTACTS
(Comment #0834 submitted by Williams) (in favor of adding a
pupillary distance requirement to the Rule).
\358\ Id.
\359\ See, e.g., Warby Parker (Comment #0817 submitted by
Kumar); Fainzilberg (Comment #0051); Wintermute (Comment #0061);
Wieczorkowski (Comment #0210); Mackey (Comment #0739); Montgomery
(Comment #0375); Savransky (Comment #0378).
\360\ Warby Parker (Comment #0817 submitted by Kumar).
\361\ See, e.g., Kao (Comment #0107); Evans (Comment #0109);
Martin (Comment #0103); Nitekman (Comment #0112); Huet (Comment
#0114); Cayabyab (Comment #0115); Smith (Comment #0118); Webb
(Comment #0121); Grazado (Comment #0122); Weinberger (Comment
#0123); Skinner (Comment #0124).
\362\ Bailer (Comment #0191); Emanuel (Comment #0282); Land
(Comment #0311).
\363\ Comment #0748 submitted by Cutler.
---------------------------------------------------------------------------

Warby Parker also commented that the Commission has previously
objected to state regulatory proposals designed to withhold certain
information necessary to fill an eyeglass prescription.\364\ The
eyeglass seller pointed to a 2011 FTC staff letter responding to the
North Carolina State Board of Opticians' proposed rule that would have,
among other things, redefined the meaning of prescriptions for
eyeglasses and contact lenses so that ``measurements taken by opticians
are not considered part of the patient's prescription, and are not
required to be released as part of a prescription.'' \365\ The 2011
staff letter, which did not specifically mention pupillary distance,
was not an opinion by staff that pupillary distance is a necessary part
of a valid eyeglass prescription, or that failure to include pupillary
distance is an unfair act or practice. Rather, Commission staff was
concerned that adoption of the North Carolina proposal would decrease
consumers' existing access to information.\366\ By contrast, the
current document considers whether to

[[Page 275]]

designate a failure to include pupillary distance as an unfair act or
practice.
---------------------------------------------------------------------------

\364\ Comment #0817 submitted by Kumar.
\365\ Letter from Susan S. DeSanti, Director, Office of Policy
Planning, Joseph Farrell, Director, Bureau of Economics, and Richard
A. Feinstein, Director, Bureau of Competition to Sue M. Kornegay, NC
State Board of Opticians, Jan. 13, 2011, https://www.ftc.gov/sites/default/files/documents/advocacy_documents/ftc-staff-comment-north-carolina-state-board-opticians-concerning-proposed-regulations-optical-goods/1101ncopticiansletter.pdf.
\366\ Id.
---------------------------------------------------------------------------

In contrast to Warby Parker and consumer commenters,
ophthalmologists and optometrists commenting on the Rule almost
universally declared that the Rule should not require that a
prescription contain pupillary distance.\367\ Some prescribers,
especially ophthalmologists, stated that they do not take this
measurement.\368\ The AOA and LensCrafters commented that prescribers
do not routinely take this measurement as part of an ``eye
examination.'' \369\ Other prescribers indicated that while they take a
``binocular'' pupillary distance measurement during their examination,
this is not always precise enough for an optician to use in making
eyeglasses.\370\
---------------------------------------------------------------------------

\367\ The AOA commented that the Rule should continue to defer
to the states on this issue. Comment #0849 submitted by Peele.
\368\ Pandit (Comment #0449) (ophthalmologist); Nichols (Comment
#0461) (ophthalmologist); Perlmutter (Comment #0464)
(ophthalmologist); Chung (Comment #0474) (ophthalmologist); Holler
(Comment #0615) (ophthalmologist who has never taken pupillary
distance in 17 years); Rosenblum (Comment #0629) (ophthalmologist
who has never taken a pupillary distance); Alvarez (Comment #0838)
(optometrist who has never taken a pupillary distance).
\369\ AOA (Comment #0849 submitted by Peele); LensCrafters
(Comment #0819 submitted by Tavel). It follows, according to the
AOA, that since pupillary distance is not derived as part of an
``eye examination,'' it does not meet the Rule's definition of a
prescription, and should not be required. Comment #0849 submitted by
Peele.
\370\ Robinson (Comment #0625); see also Shepard (Comment #0476)
(forcing eye doctors to use old technology to write the pupillary
distance on a prescription would be legislating old and outdated
technology and not in the interest of patients); Hixson (Comment
#0810) (the pupillary distance taken during the exam is an estimate
and is often highly inaccurate). Eyeglass manufacturer and seller,
ACLens, describes on its website that a binocular measurement is a
measurement from one eye's pupil to the other. Monocular PD consists
of two numbers and is the distance between the centers of each pupil
to the bridge of the nose. https://www.zennioptical.com/measuring-pd-infographic. Some commenters stated that a monocular pupillary
distance provides better centration and is therefore preferable for
use in manufacturing eyeglasses. See LensCrafters (Comment #0819
submitted by Tavel).
---------------------------------------------------------------------------

Prescribers further indicated that their principal opposition to a
requirement that they include a pupillary distance on a prescription is
that the measurement is part of the dispensing of eyeglasses and not
part of a refractive examination,\371\ and that the costs associated
with taking these measurements are built into the eyewear product and
not the examination.\372\ Some prescribers stated that if taking a
pupillary distance were to become a required part of an eye
examination, the price of an eye examination would increase.\373\ In
fact, a number of prescribers commented that if required to include it,
they would have to acquire new equipment and hire or train staff to
take this measurement.\374\ The AAO suggested that the addition of such
a requirement might cause ophthalmologists to stop providing vision-
correction exams for eyeglasses and contacts altogether, and focus
solely on eye health and medical issues.\375\
---------------------------------------------------------------------------

\371\ See, e.g., AAO (Comment #0864 submitted by Haber); AOA
(Comment #0849 submitted by Peele); Johnson (Comment #0654); Lowe
(Comment #0380); Nichols (Comment #0461); Shepherd (Comment #0476);
Patterson (Comment #0469); Chung (Comment #0474); Wareham (Comment
#0498); Yuhas (Comment #0505); Mangano (Comment #0525); Groenke
(Comment #0697); Hopkins (Comment #0776); Alvarez (Comment #0838).
This view represents a change from the position many prescribers
used to hold about what ought to be included in a prescription.
Prior to adoption of the Eyeglass Rule, many in the optometric
industry strenuously advocated for ``total vision care,'' in which
it was the prescriber's responsibility to determine all of the
parameters required to fabricate a pair of eyeglasses, including
pupillary distance. See Eyeglass I Report, supra note 6, at 255-57
(citing testimony from the Indiana Optometric Association, Ohio
State University College of Optometry, and Ron Fair, former
president of the AOA).
\372\ See, e.g., Jones (Comment #0584); Goldberg (Comment
#0824); AAO (Comment #0864 submitted by Haber).
\373\ Patterson (Comment #0469); Groenke (Comment #0697);
Hopkins (Comment #0776); AAO (Comment #0864 submitted by Haber). As
a way to offset these costs, some commenters recommend that
prescribers be able to charge consumers for this measurement.
Kirkham (Comment #0511); Goodhew (Comment #0731).
\374\ See, e.g., Rosenblum (Comment #0629) (cost of providing
care to patients will increase if he must hire an optician or
optometrist); Hopkins (Comment #0776) (new equipment); Goldberg
(Comment #0824) (prescribers are not trained and do not have staff
to take pupillary distance); AAO (Comment #0864 submitted by Haber)
(would have to hire extra staff); Narula (Comment #0578) (would
require acquisition of costly equipment).
\375\ AAO (Comment #0864 submitted by Haber); see also Kim
(Comment #0508); Croyle (Comment #0519).
---------------------------------------------------------------------------

Opticians, in general, are also largely opposed to the Rule
requiring that a prescription contain pupillary distance.\376\ Many
opticians suggested that the pupillary distance measured by a
prescriber's office should not be used to make eyeglasses.\377\ Some
opticians agreed with the prescribers who commented that prescribers'
equipment is not always sufficiently precise.\378\ Opticians stated
that an accurate measurement depends on the intended use of the
eyeglasses (e.g., reading, computer use, driving) and specific frames
chosen,\379\ the latter being information that a prescriber rarely has
at the time the prescription is written following the exam. According
to some commenters, to obtain an accurate pupillary distance, one needs
to know specifically the lens shape and size, as well as the horizontal
and vertical placement of the glasses on an individual's face.\380\
Some commenters also noted that there may be different pupillary
distance measurements for near and far viewing distances, and so multi-
focal lenses may have more than one pupillary distance.\381\
---------------------------------------------------------------------------

\376\ See, e.g., Opticians Association of America (Comment #0638
submitted by Allen); Opticians Alliance of New York (Comment #0642
submitted by Cullen); Opticians Association of Iowa (Comment #0646
submitted by Dalton); Opticians Association of Virginia (Comment
#0647 submitted by Nelms); Poe (Comment #0648); Montavon (Comment
#0649); Professional Opticians of Florida (Comment #0803 submitted
by Couch); Opticians Association of Alaska, Inc. (Comment #0852
submitted by Brand); Shelton (Comment #0585); Evans (Comment #0661);
Damisch (Comment #0675); Whatley (Comment #0676); Jackson (Comment
#0793); Wood (Comment #0709); Chamberlain (Comment #0713); Connor
(Comment #0721); Tanzi (Comment #0723); Oxenford (Comment #0724);
Reed (Comment #0738); Shroyer (Comment #0743); Ahrens (Comment
#0022); Hummel (Comment #0788). While the NAOO was unable to reach a
consensus on this issue, it recognized that the absence of a
pupillary distance on a prescription creates hurdles for consumers
who wish to purchase their eyeglasses online. Comment #0748
submitted by Cutler.
\377\ See, e.g., Opticians Association of America (Comment #0638
submitted by Allen); Shelton (Comment #0585); Opticians Association
of Iowa (Comment #0646 submitted by Dalton); Parent (Comment #0693);
Evans (Comment #0661); Damisch (Comment #0675); Whatley (Comment
#0676); Reynolds (Comment #0726).
\378\ Opticians Association of Alaska, Inc. (Comment #0852
submitted by Brand); Fitzgerald (Comment #0818); see also Cooper
(Comment #0562) (ophthalmologist who indicates he would be unable to
provide an accurate pupillary distance measurement to his patients);
LensCrafters (Comment #0819 submitted by Tavel) (stating that the
digital technology required to accurately obtain the pupillary
distance does not typically exist in the doctor's space).
\379\ Edwards (Comment #0360); Cervantes (Comment #0671); Ahrens
(Comment #0022); Stuart (Comment #0841); see also Shepherd (Comment
#0476) (prescriber); Archibald (Comment #0729) (optometrist).
\380\ Opticians Association of Virginia (Comment #0647 submitted
by Nelms); Cervantes (Comment #0671); Archibald (Comment #0729);
Ahrens (Comment #0022); see also Santini article, supra note 340 (as
the sophistication of eyeglass lenses has advanced, prescribers have
improved their understanding of how measurements beyond simple pupil
location help optimize lens acuity, comfort, and utility).
Commenters also stated that other measurements are needed for
dispensing eyeglasses, such as base curve and segment height, and
that prescribers are not also required to take those measurements.
Edwards (Comment #0360) (as important as the pupillary distance
generally is, other measurements and considerations are at least as
important); Kalish (Comment #0048; Haas (Comment #0359); Yuhas
(Comment #0505); Rosenblum (Comment #0629).
\381\ Narula (Comment #0578); Hamilton (Comment #0867); Hamilton
(Comment #0868); Archibald (Comment #0729); LensCrafters (Comment
#0819 submitted by Tavel); see also ACLens, ``Measuring Pupillary
Distance (PD),'' https://www.aclens.com/measuring-pupillary-distance
(stating that if a consumer requires prescription bifocal glasses
she will need both a near and distance PD and that the near PD is
calculated by subtracting 3mm from the distance PD).

---------------------------------------------------------------------------

[[Page 276]]

Opticians indicated they are trained to take an accurate pupillary
distance as part of the process of fitting eyeglasses, whereas
prescribers are not specifically trained to take this measurement.\382\
According to these opticians, if prescribers are required to provide
pupillary distance on a prescription, some opticians will by law be
forced to adhere to the measurement on the prescription, rather than to
their own measurement, which might be more accurate.\383\ For instance,
in North Carolina, state law specifies that an optician may not
contradict measurements taken by a prescriber; in Oregon, opticians are
required to grind eyeglasses in conformity with prescriptions.\384\
Should the Commission require prescribers to include pupillary distance
on prescriptions, opticians in North Carolina, Oregon, and other states
with similar laws might no longer have the right to make glasses from
their own pupillary distance measurements. Opticians also expressed
concern that this might make them liable for errors resulting from
improper measurements written by a prescriber and that they would have
to absorb the costs involved in remaking the glasses, or pass along
those costs to consumers.\385\
---------------------------------------------------------------------------

\382\ See, e.g., Opticians Association of America (Comment #0638
submitted by Allen); Damisch (Comment #0675). Some prescribers
corroborated optician comments as to opticians' ability or training
to take these measurements, or as to their own lack of training or
ability to take these measurements. Lunsford (Comment #0346);
Wnorowski (Comment #0484); Kopp (Comment #0491); Cooper (Comment
#0562); Narula (Comment #0578); Fyffe (Comment #0581); Rosenblum
(Comment #0629).
\383\ See, e.g., Opticians Association of America (Comment #0638
submitted by Allen); Opticians Association of Kentucky (Comment
#0640 submitted by Castle); Opticians Association of Vermont
(Comment #0641 submitted by Williams); Opticians Alliance of New
York (Comment #0642 submitted by Cullen); Robinson (Comment #0643);
Duff (Comment #0653); Johnson (Comment #0654); Thetford (Comment
#0659); Crabtree (Comment #0666); Groenke (Comment #0697); Hopkins
(Comment #0776); South Carolina Association of Opticians (Comment
#0822 submitted by Harbert).
\384\ 21 N.C. Admin. Code 40.0210; Or. Rev. Stat. Sec. 683.520.
\385\ See, e.g., Opticians Association of America (Comment #0638
submitted by Allen); Opticians Association of Vermont (Comment #0641
submitted by Williams); Opticians Alliance of New York (Comment
#0642 submitted by Cullen); Opticians Association of Kentucky
(Comment #0640 submitted by Castle); Robinson (Comment #0643); Duff
(Comment #0653); Johnson (Comment #0654); Thetford (Comment #0659);
Crabtree (Comment #0666); Groenke (Comment #0697); Hopkins (Comment
#0776); South Carolina Association of Opticians (Comment #0822
submitted by Harbert). On the other hand, some prescribers expressed
concerns that they would be liable for mistakes made by opticians
who use prescribers' pupillary distance measurements. Chung (Comment
#0454); Nichols (Comment #0461); Michel (Comment #0472); Azar
(Comment #0518).
---------------------------------------------------------------------------

4. Analysis of Whether To Amend the Rule To Require Pupillary Distance
To determine that 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.\386\ As
previously discussed, purchasing eyeglasses online can be more
convenient and less costly for consumers.\387\ Without a pupillary
distance measurement included on their prescriptions, some consumers
may be hampered in their ability to shop online for eyeglasses because
they must obtain this information independently. However, since other
methods are available for consumers to obtain this measurement and use
it to comparison shop, the Commission does not believe, at this time,
that there is an adequate record to demonstrate that prescribers'
failure to provide pupillary distance measurements on prescriptions
constitutes substantial injury. As discussed above, those consumers who
wish to shop online and do not already have their pupillary distance
can obtain that measurement through other methods, many of which are no
cost or relatively low-cost, and can thereafter provide sellers with
this information. For example, a number of online sellers offer
directions and online tools for consumers to measure their own
pupillary distance, or to have someone they know measure their
pupillary distance, using readily available objects like a credit card
and a webcam.\388\
---------------------------------------------------------------------------

\386\ 15 U.S.C. 45(n).
\387\ See Section I.C, supra.
\388\ See Section V.A, supra.
---------------------------------------------------------------------------

In addition, according to many prescribers and optician commenters,
imposing a requirement to include pupillary distance in the
prescription may be detrimental for prescribers and consumers in one or
more of the following ways. Some prescribers would be required to take
a measurement that they do not ordinarily take, or have never taken.
According to commenters, due to a prescriber's use of inadequate
equipment, or a lack of training, and the fact that prescribers do not
have the benefit of adjusting the pupillary distance to accommodate the
fit of a particular pair of eyeglasses, consumers may obtain inaccurate
measurements.\389\ Moreover, it is possible that optician reliance on a
prescriber's measurements, mandated by law in some jurisdictions, could
result in improperly-made eyeglasses, which would increase the
inconvenience and cost to opticians, consumers, and prescribers.\390\
If an optician makes a pair of eyeglasses using a prescriber-provided
pupillary distance measurement that a consumer finds uncomfortable, the
consumer would need to obtain a new prescription containing a revised
pupillary distance before an optician could remake the eyeglasses. If
these prescribers and optician commenters are correct, a requirement to
include pupillary distance in prescriptions could be detrimental to
consumers and competition.
---------------------------------------------------------------------------

\389\ See notes 378-382, supra.
\390\ See notes 383, 385, supra.
---------------------------------------------------------------------------

In addition, if the Commission required prescribers to include
pupillary distance measurements on prescriptions, it is unlikely that
prescribers would use less expensive pupillary distance rulers and the
like, but instead--for professional and liability reasons--would likely
select more technologically sophisticated methods, such as a digital
centration device, to take the measurement. Such devices, and the
training, staff, and exam time necessary to operate the devices, could
be costly. Some prescribers could pass these costs on to their patients
in the form of higher prices.\391\ Alternatively, some prescribers
could choose not to provide refractive services.\392\
---------------------------------------------------------------------------

\391\ See note 373, 374, supra.
\392\ See note 375, supra.
---------------------------------------------------------------------------

As is evidenced by the title of the Rule, ``Separation of
examination and dispensing,'' the Rule distinguishes between the
examination that determines refraction and the sale of eyeglasses.
Pupillary distance involves the fitting of a pair of eyeglasses to
one's face, and is thus typically considered part of the dispensing
process. If the Commission required prescribers to include pupillary
distance on prescriptions, in offices with dispensaries, the
prescriber, instead of adding expensive pupillary-distance measurement
equipment to the exam room, might lead the patient into the dispensary
to measure the patient's pupillary distance. Such a shift would place
the patient in the dispensary prior to the patient receiving her
prescription, undercutting both the Rule's requirement to release
eyeglass prescriptions to patients immediately upon completion of an
eye examination, and the Rule's long-standing emphasis on keeping the
refractive examination distinct from, and untied to, the sale of
eyeglasses.
Based on its consideration of the relevant factors, the Commission
is not convinced that there is adequate

[[Page 277]]

evidence in the current rulemaking record to determine that the failure
to provide a pupillary distance on a prescription is an unfair
practice.\393\ The Commission therefore does not propose requiring
prescribers to include the pupillary distance measurement on
prescriptions. It does not appear to the Commission that the potential
benefits to consumers or competition from a Rule change requiring the
inclusion of pupillary distance on prescriptions outweigh the
consequences detailed by prescribers and opticians, especially if
consumers who wish to purchase their eyeglasses online can obtain their
pupillary distance independently, at no cost or a relatively low cost.
The Commission understands that requiring prescribers to provide
pupillary distance might be more convenient for some consumers and
online retailers, and may help foster a competitive market, but the
Commission believes, as it did at the time of the Rule's issuance, that
absent a record demonstrating that the failure to include pupillary
distance as part of the prescription constitutes an unfair practice,
the states should continue to determine the contents of eyeglass
prescriptions.\394\ The Commission recognizes that it last invited
comment on the question of whether to require the inclusion of
pupillary distance in a prescription in its 2015 ANPR,\395\ and the
online market for optometry and eyeglasses may have evolved since that
round of comments. Thus, it invites comments from any organizations or
individuals who believe that, in analyzing this issue, the Commission
should consider relevant changes to state regulations on the content of
prescriptions, or to changes in the marketplace or to technology
pertaining to pupillary distance, since it last sought comment.
---------------------------------------------------------------------------

\393\ Since the Commission has not found the practice of failing
to include a pupillary distance measurement on a prescription to be
unfair, it does not need to evaluate whether this practice is
prevalent.
\394\ See Section V.A, supra (explaining that the Rule's
definition of 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,'' 16 CFR 456.1, leaves it
to the states to determine what must be included in a prescription,
and that only four states currently require the inclusion of
pupillary distance measurements on prescriptions); see also, Section
I.D, supra (discussing how state laws and regulations, and not the
Eyeglass Rule, govern most aspects of professional practice and
eyewear sales). Some commenters recommended that the Commission
require a prescription to include a ``best corrected visual acuity''
or ``best corrected vision,'' a measurement that allows the person
filling the eyeglass prescription to know what line of letters on an
eye chart a consumer should be able to see with that prescription.
Professional Opticians of Florida (Comment #0803 submitted by
Couch); Stuart (Comment #0841). The Commission also believes that
whether such a measurement is required on a prescription should be
determined by the states.
\395\ See Eyeglass Rule ANPR, 80 FR 53274, 53276.
---------------------------------------------------------------------------

B. Amending the Rule To Set an Expiration Date for Eyeglass
Prescriptions

Although the 2015 ANPR for the Eyeglass Rule did not specifically
request comment on the issue of expiration dates for eyeglass
prescriptions, several commenters raised this topic. The Eyeglass Rule,
as currently drafted, does not specifically address expiration dates
for eyeglass prescriptions. Rather, the Rule defines an eyeglass
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.\396\ State laws determine whether a prescription must
contain an expiration date, but these laws vary; some states require an
expiration date on the prescription,\397\ others do not.\398\
Furthermore, to the extent state laws specify the length of time an
eyeglass prescription is valid, these laws vary as well.\399\
---------------------------------------------------------------------------

\396\ 16 CFR 456.1(g).
\397\ Alaska Admin. Code 12 Sec. 48.920; Cal. Bus. & Prof. Code
Sec. 2541.1; La. Admin. Code tit. 46, Sec. LI-505; 246 Mass. Code
Regs. 3.02; Miss. Code Ann. Sec. 73-19-61; N.D. Admin. Code 56-02-
04-03; 49 Pa. Code Sec. 23.72.
\398\ Ark. Code Ann. Sec. 17-90-108 (A)(3); Md. Code Ann.
Health Occ. Sec. 11-504.
\399\ Cal. Bus. & Prof. Code Sec. 2541.1 (no less than two to
four years from the date of issuance unless medical reason for
shorter period); Fla. Stat. Ann. Sec. 463.012 (expiration date of 5
years); Haw. Code R. Sec. 16-92-2 (expiration date to be determined
by licensed practitioner); Idaho Amin. Code R. Sec. 24.10.450
(expiration date of at least one year); Iowa Admin. Code. r. 645-
182.3 (expiration date not to exceed two years); La. Admin. Code
tit. 46, Sec. LI-505 (expiration date may not exceed 18 months,
unless medical reason); see also, DC Mun. Regs. tit. 17, Sec.
6416.1 (expiration date of one year unless medical reason for
shorter time period).
---------------------------------------------------------------------------

Some commenters suggested a variety of Rule amendments that would
address the length of an eyeglass prescription, while other commenters
expressed the view that the Commission should not amend the Rule to set
expiration dates for eyeglass prescriptions. In advocating for an
amendment to the Rule, some commenters expressed concern that since the
expiration period for eyeglass prescriptions is not standardized, it
allows some states ``to impose arbitrary and, in some cases,
unnecessarily short, expiration periods for prescriptions.'' \400\ For
example, Warby Parker commented that ``many state laws allow `short-
dated' prescriptions, which force consumers to go back to their eye
care professional each year if they want to obtain a valid prescription
for new eyeglasses.'' \401\ Warby Parker argued that these provisions
are without justification because the ``vast majority of [eyeglass]
prescriptions do not change within one year, and there is no medical
rationale for most patients to undergo annual eye exams.'' \402\ U.S.
Senator Charles Schumer requested that the Commission consider whether
short-term prescriptions (for example, a year or less), are appropriate
or fair for consumers given that vision does not necessarily change
this rapidly.\403\ 1-800 CONTACTS concurred with this view, stating
that allowing states to impose ``arbitrary and, in some cases,
unnecessarily short, expiration periods for prescriptions impairs the
intent and effectiveness of the Eyeglass Rule and inhibits consumer's
ability to choose to obtain eyeglasses from third-party sellers.''
\404\ 1-800 CONTACTS pointed out that, for this reason, the Contact
Lens Rule includes a provision that addresses the expiration of contact
lens prescriptions.\405\
---------------------------------------------------------------------------

\400\ 1-800 CONTACTS (Comment #0834 submitted by Williams); see
also Warby Parker (Comment #0817 submitted by Kumar).
\401\ Comment #0817 submitted by Kumar (citing as examples the
state statutes of Iowa, Mississippi, and Pennsylvania, as well as
the District of Columbia's Eyeglass Rule).
\402\ Id.
\403\ Comment #0865.
\404\ Comment #0834 submitted by Williams.
\405\ See 16 CFR 315.6 (setting a minimum expiration date of one
year after the issue date of a prescription with an exception based
on a patient's ocular health).
---------------------------------------------------------------------------

1-800 CONTACTS therefore proposed that the Commission amend the
Eyeglass Rule to include a provision imposing a minimum expiration
period for prescriptions, with an exception for documented medical
necessity, as there is in the CLR.\406\ Similarly, Warby Parker
proposed that the Commission amend the Rule to adopt a three-year
minimum prescription expiration timeframe, absent a documented medical
basis for any particular short-dated prescription.\407\
---------------------------------------------------------------------------

\406\ Comment #0834 submitted by Williams.
\407\ Comment #0817 submitted by Kumar; see also Buntain
(Comment #0529) (amend the Rule to prohibit short-dated
prescriptions without a medical necessity); Read (Comment #0741)
(make prescriptions valid for three years).
---------------------------------------------------------------------------

Many consumers expressed frustration that eyeglass prescriptions
expire too quickly and prevent them from purchasing new pairs of
eyeglasses without undergoing another eye exam.\408\ For example, some

[[Page 278]]

commenters stated that their prescription rarely or never changes, but
if they want new glasses or a second pair of glasses more than a year
or two after their initial examination, a prescription expiration date
may nonetheless require them to return to the prescriber's office for a
new eye examination.\409\ Some commenters discussed the costs
associated with having to obtain another eye examination to get a
prescription even though they were satisfied with their current
prescription, or believed that their vision had not changed.\410\ Other
commenters argued that patients should be able to decide for themselves
when they want to update their eyeglass prescriptions.\411\
---------------------------------------------------------------------------

\408\ See, e.g., Skidelsky (Comment #0085); Hendrick (Comment
#0088); Loeb (Comment #0314); Bevington (Comment #0419); Gough
(Comment #0422); Kinlaw (Comment #0424); Holden (Comment #0428);
Steele (Comment #0432); Martin (Comment #0435); Miller (Comment
#0437); Fernandez (Comment #0439); Washburn (Comment #0440);
Birnbaum (Comment #0443); McLeod (Comment #0458); Kaminski (Comment
#0462); Munkittrick (Comment #0465); Kaprielian (Comment #0488);
Rouse (Comment #0496); Pearsall (Comment #0499); Simmons (Comment
#0513); Iglinski (Comment #0516); Lauridsen (Comment #0526); Hamon
(Comment #0537); Schutz (Comment #0549); Fair (Comment #0800); see
also Garcia (Comment #0338) (Warby Parker employee reporting that
consumers are unhappy with one-year expiration dates when their
prescriptions have not changed); Beaudoin (Comment #0349) (same);
Grecxo (Comment #0612) (Warby Parker optician reporting that
expiration dates of less than two years make obtaining eyeglasses
difficult and frustrating for some patients).
\409\ See, e.g., Nystrom (Comment #0254); Hollis (Comment
#0307); Trout (Comment #0383); Bhattacharyya (Comment #0543); Morel
(Comment #0712).
\410\ See, e.g., Sorenson (Comment #0080) (burden financially
and time-wise to have to get re-examined every year); Kim (Comment
#0192) (eye exams are expensive); Meszaros (Comment #0303) (one-year
expiration dates increase annual costs without materially improving
health care); Hollis (Comment #0526) (would like to see doctor less
frequently); Gough (Comment #0422) (getting a new prescription not
cheap); Holden (Comment #0428) (getting time off for an eye exam is
difficult); Davis (Comment #0433) (have to pay for exam on top of
the new eyeglasses); Martin (Comment #0435); Washburn (Comment
#0440); Birnbaum (Comment #0443); Kaprielian (Comment #0488); Rouse
(Comment #0496); Pearsall (Comment #0499); Buntain (Comment #0529);
Buntain (Comment #0531) (prescriptions expire too soon and not
everyone can afford to go to the doctor so often).
\411\ See, e.g., Hildenbrand (Comment #0049; Cordivari (Comment
#0069); Sorenson (Comment #0080); Forrest (Comment #0270); Jump
(Comment #0292); Loeb (Comment #0171); Richards (Comment #0401);
Steele (Comment #0432); Davis (Comment #0433).
---------------------------------------------------------------------------

Some commenters proposed that the Commission amend the Rule to
prohibit eyeglass prescriptions from including an expiration date at
all.\412\ For example, the Opticians Association of Virginia stated
that absent a medical reason with corroborating pathology, it saw no
valid reason for an eyeglass prescription to contain an expiration
date.\413\ This commenter argued that eyeglasses worn by the patient do
not expire on a given date, and accordingly, there is no reason for the
underlying prescription to expire.\414\ The association further
explained that because opticians can use a customer's existing pair of
eyeglasses to ascertain the prescription parameters and make another
pair using those parameters, from neutralizing or duplicating
eyeglasses, expiration dates can be (and often are) circumvented.\415\
---------------------------------------------------------------------------

\412\ See, e.g., Forrest (Comment #0270) (prescriptions should
not expire); Endelson (Comment #0407) (prescription should include
date of examination but not an expiration date); Professional
Opticians of Florida (Comment #0803 submitted by Couch)
(recommending the prohibition of expiration dates on prescriptions
for adult patients with low risk factors).
\413\ Comment #0647 submitted by Nelms.
\414\ Id.; see also Rhodes (Comment #0334) (one- or two-year
expiration dates do not make sense and make it difficult to get
replacement eyeglasses that one would otherwise be wearing but for
losing them).
\415\ Comment #0647 submitted by Nelms.
---------------------------------------------------------------------------

However, other commenters, citing the importance of annual eye
exams to consumers' eye health, stated that prescriptions should
contain expiration dates, set at the discretion of the prescribing
practitioner.\416\ The AAO, and several other commenters, stated that
the Rule should not be amended to extend the expiration of
prescriptions beyond one year.\417\ These commenters stressed the
importance of yearly eye examinations, which function to monitor the
health of the eye, and noted that patients' prescriptions often change.
Many opticians, also advocating for yearly eye examinations, stated a
preference for one-year expiration dates, but said that they would not
be opposed to accepting prescriptions within a two-year period.\418\
The AOA recommended that the Commission not amend the Rule to address
expiration dates, but rather continue to defer to state law and the
medical judgment of optometrists and ophthalmologists as to when a
prescription should expire.\419\ The Rule's purpose is to allow
consumers to comparison-shop for eyeglasses. In its comment, Warby
Parker stated that short-term prescriptions require patients to return
to the eye care prescriber more frequently, giving the prescriber
additional opportunities to sell eyeglasses to patients.\420\ In
support of this position, Warby Parker pointed to a handful of states
that have enacted laws and regulations making the maximum effective
date for prescription lenses one or two years. A review of various
states' regulations on prescription expirations, however, indicates
that many states do not regulate the length of eyeglass
prescriptions.\421\ Of the states that do regulate expiration dates,
some set a floor for expiration, rather than a ceiling.\422\ Of the
states that do specifically limit the length of an eyeglass
prescription, many set the expiration date at two or more years.\423\
---------------------------------------------------------------------------

\416\ Kalish (Comment #0048); Edwards (Comment #0360); Smith
(Comment #0652); Lott (Comment #0655); Ambler (Comment #0025).
\417\ Comment #0864 submitted by Haber; see also Adegbile
(Comment #0004); Sung (Comment #0459); Jamison (Comment #0535);
Moschell (Comment #0551); Shuler (Comment #0572); Cochrane (Comment
#0583); Rozanec (Comment #0613); Leung (Comment #0623); Hicks
(Comment #0624); Brosman (Comment #0637); Valentine (Comment #0644).
\418\ Opticians Association of America (Comment #0638 submitted
by Allen); Opticians Association of Kentucky (Comment #0640
submitted by Castle); Opticians Association of Vermont (Comment
#0641 submitted by Williams); Opticians Alliance of New York
(Comment #0642 submitted by Cullen); Ragan (Comment #0677);
Opticians Association of Ohio (Comment #0683 submitted by Glasper);
Parent (Comment #0693); Opticians Association of Iowa (Comment #0646
submitted by Dalton); Sasse (Comment #0733); Martin (Comment #0665);
South Carolina Association of Opticians (Comment #0822 submitted by
Harbert).
\419\ Comment #0849 submitted by Peele.
\420\ Comment #0817 submitted by Kumar.
\421\ See, e.g., Ark. Code Ann. Sec. 17-90-108 (A)(3); Md. Code
Ann., Health Occ. Sec. 11-504; N.C. Gen. Stat. Ann. Sec. 90-235;
Utah Code Ann. Sec. 58-16A-102 (prescription may include an
expiration date).
\422\ See Cal. Bus. & Prof. Code Sec. 2541.1 (should not be
less than 2-4 years); Idaho Amin. Code R. Sec. 24.10.450 (must be
at least one year); Wash. Rev. Code Sec. 18.195.030 (at least two
years).
\423\ Fla. Stat. Ann. Sec. 463.012 (valid for a period of 5
years); Iowa Admin. Code. r. 645-182.3 (not to exceed two years);
Me. Rev. Stat. tit. 34 A-2 Sec. 2417 (not more than two years
unless medical reason for a longer period); Nev. Rev. Stat. Sec.
637.175 (two years unless specified otherwise by prescriber); N.H.
Rev. Stat. Ann. Sec. 327-A:1 (not more than 24 months); 49 Pa. Code
Sec. 23.72 (cannot exceed two years).
---------------------------------------------------------------------------

Commenters seem to be arguing that expiration dates on
prescriptions prevent consumers from continuing to purchase eyeglasses
for a sufficiently long period before having to return to their eye
doctors. The Commission lacks adequate evidence that eyeglass
prescription expiration dates, whether imposed by state regulations or
individual prescribers, impair comparison-shopping, and hence
competition in the retail sale of eyeglasses, to an extent that would
justify a new regulatory requirement.\424\
---------------------------------------------------------------------------

\424\ In its comment to the current rule review, the AOA stated
its belief that eye care practitioners do not use expiration dates
to impede the ability of their patients to purchase eyeglasses from
other retailers. Comment #0849 submitted by Peele.
---------------------------------------------------------------------------

While requiring that consumers return to their prescriber
periodically for exams may give the prescriber a competitive advantage
in that they get a ``first shot'' at selling the consumers new
eyeglasses, it does not necessarily limit the consumers' choices or
ability to comparison-shop, particularly if the prescribers abide by
the Rule's prescription release requirement.

[[Page 279]]

Absent evidence that expiration dates are impeding consumer choice, the
Commission sees no support for the proposal that expiration dates need
to be standardized.
Although some patients will not be able to purchase eyeglasses
using a prescription more than one or two years old, this does not mean
that they were foreclosed from comparison-shopping or from purchasing
from the retailer of their choice when they initially purchased
eyeglasses. Furthermore, as long as patients are provided a copy of the
eyeglass prescription after the eye examination is completed, there is
nothing in the record to support the contention that merely returning
to a prescriber's office to obtain a new prescription will pressure the
patient into purchasing from the prescriber. Accordingly, the
Commission has determined not to propose to amend the Rule either to
prohibit expiration dates or to set expiration dates for eyeglass
prescriptions.\425\
---------------------------------------------------------------------------

\425\ In its 2004 review of the Eyeglass Rule, the Commission
declined to consider amending the Rule to set expiration dates for
eyeglass prescriptions. In that proceeding, the Opticians
Association of America asked the Commission to amend the Rule to
prohibit the use of expiration dates for eyeglass prescriptions,
with exceptions for specific, well-defined medical reasons, arguing
that practitioners used arbitrary and unjustifiable expiration dates
to deter consumers from using their eyeglass prescriptions.
Ophthalmic Practice Rules, 69 FR 5451, 5454. Because there was no
evidence in that record that eye care prescribers were using
expiration dates as a means of impeding consumers' ability to
purchase eyeglasses from other sellers or otherwise causing consumer
injury, the Commission decided not to set expiration dates for
eyeglass prescriptions. Id. Commission staff reached a similar
conclusion in a prior Eyeglass Rule review, determining that
prescription expiration duration should be left to the states. See
1980 Staff Report, supra note 25.
---------------------------------------------------------------------------

C. Amending Other Rule Definitions

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.''
\426\ The AOA and several individual prescribers requested that the
Commission modify the Rule to change the term ``eye examination'' to
``refraction.'' \427\ 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.\428\
---------------------------------------------------------------------------

\426\ 16 CFR 456.1(b).
\427\ See AOA (Comment #0849 submitted by Peele); Brauer
(Comment #0045); Yadon (Comment #0046; Bolenbaker (Comment #0633).
Some of these commenters also stated that the defined term in the
Rule is at odds with the definition of eye examination in the
American Medical Association's Current Procedural Terminology codes
to bill outpatient and office procedures, because that definition
does not include a refraction. AOA (Comment #0849 submitted by
Peele); Bolenbaker (Comment #0633).
\428\ AOA (Comment #0849 submitted by Peele); Lunsford (Comment
#0346); Bolenbaker (Comment #0633).
---------------------------------------------------------------------------

Two commenters, in particular, noted that that eye examinations and
refractions are separate services and that the Commission's use of the
terminology ``eye examination,'' instead of ``refraction,'' results in
confusion for the consumer.\429\ Such confusion may stem from the fact
that, in addition to assessing a fee for determining the health of the
eye--a fee often covered by health insurance or Medicare--prescribers
charge patients a fee for the refractive examination that results in a
prescription, a fee that Medicare does not cover.\430\ 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.\431\
---------------------------------------------------------------------------

\429\ Lehman (Comment #0610); Bolenbaker (Comment #0633).
\430\ See Lehman (Comment #0610). Medicare does not cover
refractive examinations for eyeglasses. See U.S. Centers for
Medicare & Medicaid Services, ``Your Medicare Coverage,'' https://www.medicare.gov/coverage/eye-exams.html.
\431\ The prescriber is permitted to withhold the prescription
until the patient has paid for the eye examination, but only if that
ophthalmologist or optometrist would have required immediate payment
from that patient had the examination revealed that no ophthalmic
goods were required. 16 CFR 456.2(a).
---------------------------------------------------------------------------

The Commission proposes to replace the term ``eye examination''
with ``refractive eye examination'' throughout the Rule. 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 be
provided free of any additional charge, without obligation, and without
a waiver. The Commission believes 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.

VI. Recommendations Regarding the Commission's Complaint System

To assist the Commission in its enforcement of the Rule, Warby
Parker suggested that the Commission create a more ``user-friendly''
online complaint process for consumers.\432\ The online complaint
process has changed significantly since the receipt of this comment.
The current website is user-friendly, and consumers can easily find eye
care as a category for their complaints.\433\ On the home page, one of
the 10 listed complaint categories is for ``health (ex. weight loss,
eye care, treatment).'' When consumers select the health category, a
new menu pops up which shows ``eye care'' as one of five choices, and
after selecting that category, consumers are given ample room to
describe their experience in a comment box under the request to
``Describe what happened.'' Accordingly, the Commission believes that
the FTC complaint system is well-configured to capture and report
eyeglass-related complaints it receives, whether they originate from
consumers, prescribers, sellers, or others.
---------------------------------------------------------------------------

\432\ Comment #0817 submitted by Kumar.
\433\ See www.reportfraud.ftc.gov.
---------------------------------------------------------------------------

VII. Request for Comment

You can file a comment online or on paper. For the Commission to
consider your comment, we must receive it on or before March 6, 2023.
Write ``Eyeglass Rule, Project No. R511996'' on the comment. Your
comment--including your name and your state--will be placed on the
https://www.regulations.gov website.
Because of public health measures and the agency's heightened
security screening, postal mail addressed to the Commission will be
subject to delay. We strongly encourage you to submit your comment
online through the https://www.regulations.gov website. To ensure the
Commission considers your online comment, please follow the
instructions on the web-based form.
If you file your comment on paper, write ``Eyeglass Rule, Project
No. R511996'' on your comment and on the envelope, and mail your
comment to the following address: Federal Trade Commission, Office of
the Secretary, 600 Pennsylvania Avenue NW, Suite CC-5610 (Annex C),
Washington, DC 20580.
Because your comment will be placed on the publicly accessible
website https://www.regulations.gov, you are solely responsible for
making sure your comment does not include any sensitive or confidential
information. In particular, your comment should not

[[Page 280]]

include any sensitive personal information, such as your or anyone
else's Social Security number; date of birth; driver's license number
or other state identification number, or foreign country equivalent;
passport number; financial account number; or credit or debit card
number. You are also solely responsible for making sure your comment
does not include any sensitive health information, such as medical
records or other individually identifiable health information. In
addition, your comment should not include any ``trade secret or any
commercial or financial information which . . . is privileged or
confidential''--as provided by section 6(f) of the FTC Act, 15 U.S.C.
46(f), and FTC Rule Sec. 4.10(a)(2), 16 CFR 4.10(a)(2)--including in
particular competitively sensitive information such as costs, sales
statistics, inventories, formulas, patterns, devices, manufacturing
processes, or customer names.
Comments containing material for which confidential treatment is
requested must be filed in paper form, must be clearly labeled
``Confidential,'' and must comply with FTC Rule Sec. 4.9(c). In
particular, the written request for confidential treatment that
accompanies the comment must include the factual and legal basis for
the request, and must identify the specific portions of the comment to
be withheld from the public record. See FTC Rule Sec. 4.9(c). Your
comment will be kept confidential only if the General Counsel grants
your request in accordance with the law and the public interest. Once
your comment has been posted publicly at www.regulations.gov--as
legally required by FTC Rule Sec. 4.9(b)--we cannot redact or remove
your comment from the FTC website, unless you submit a confidentiality
request that meets the requirements for such treatment under FTC Rule
Sec. 4.9(c), and the General Counsel grants that request.
Visit the Commission website at http://www.ftc.gov to read this
NPRM and the news release describing it. The FTC Act and other laws
that the Commission administers permit the collection of public
comments to consider and use in this proceeding as appropriate. The
Commission will consider all timely and responsive public comments that
it receives on or before March 6, 2023. For information on the
Commission's privacy policy, including routine uses permitted by the
Privacy Act, see https://www.ftc.gov/site-information/privacy-policy.
The Commission invites members of the public to comment on any
issues or concerns they believe are relevant or appropriate to the
Commission's consideration of proposed amendments to the Rule. The
Commission requests that you provide factual data, and in particular,
empirical data, upon which your comments are based. In addition to the
issues raised above, the Commission solicits public comment on the
specific questions identified below. These questions are designed to
assist the public and should not be construed as a limitation on the
issues on which public comment may be submitted.

Questions

A. General Questions on Proposed Amendments: To maximize the
benefits and minimize the costs for prescribers and sellers (including
small businesses), the Commission seeks views and data on the following
general questions for each of the proposed changes described in this
NPRM:
1. What benefits would a proposed change confer and on whom? The
Commission in particular seeks information on any benefits a change
would confer on consumers of eyeglasses.
2. What costs or burdens would a proposed change impose and on
whom? The Commission in particular seeks information on any burdens a
change would impose on small businesses.
3. What regulatory alternatives to the proposed changes are
available that would reduce the burdens of the proposed changes while
providing the same benefits?
4. What additional information, tools, or guidance might the
Commission provide to assist industry in meeting extant or proposed
requirements efficiently?
5. What evidence supports your answers?
B. Marketplace, Technological, and State Regulatory Changes:
1. Since the public last had an opportunity to comment, are there any
technological changes, changes in the marketplace, or to state
regulations pertaining to pupillary distance, that the Commission
should consider?
C. Confirmation of Prescription Release:
1. Would the proposed Confirmation of Prescription Release
provision increase, decrease, or have no effect on compliance with the
Rule's requirement that patients receive a copy of their prescription
after the completion of a refractive eye examination? Why?
2. Would the proposed requirement that prescribers would have to
maintain evidence of the Confirmation of Prescription Release for at
least three years increase, decrease, or have no effect on the
Commission's ability to enforce, and monitor compliance with, the
Rule's automatic prescription release provision? Why?
3. Would the proposed Confirmation of Prescription Release
requirement increase, decrease, or have no effect on the extent to
which patients understand their rights under the Rule? Why?
4. Does the proposal to allow prescribers to satisfy the
Confirmation of Prescription Release requirement by releasing a digital
copy of the prescription to the patient (after obtaining the patient's
verifiable affirmative consent), such as via online portal, electronic
mail, or text message increase, decrease, or have no effect on the
extent to which patients understand their rights under the Rule? Why?
5. If prescribers choose to comply with the Confirmation of
Prescription Release provision by providing a digital copy of the
prescription (if the patient gives verifiable affirmative consent),
what costs or burdens are associated with retaining evidence that the
prescription was sent, received, or made accessible, downloadable, and
printable?
6. Do the potential benefits of the Confirmation of Prescription
Release requirement--having more patients in possession of their
prescription--outweigh the burden on prescribers of having to provide
patients with a Confirmation of Prescription Release and preserve a
record for three years? Why or why not?
7. What other factors should the Commission consider to lower the
cost and improve the reliability of executing, storing, and retrieving
Confirmations of Prescription Release?
8. Are there alternate ways that the Commission has not yet
considered to design a Confirmation of Prescription Release requirement
that would reduce the burden on prescribers while providing the same,
or greater, benefits for consumers? What are they and how do they
compare to the current proposal?
9. Are there alternate ways that the Commission has not yet
considered in this Rule review to increase compliance with the Rule's
requirement that patients receive a copy of their eyeglass prescription
after the completion of a refractive eye examination? What are they and
how do they compare to the current proposal?
10. Are there alternate ways that the Commission has not yet
considered in its Rule review to increase the Commission's ability to
enforce, and monitor compliance with, the Rule's automatic prescription
release

[[Page 281]]

provision? What are they and how do they compare to the current
proposal?
11. Are there alternate ways that the Commission has not yet
considered in its Rule review to increase the extent to which patients
understand their rights under the Rule? What are they and how do they
compare to the current proposal?
12. Under the Commission's proposal, the Confirmation of
Prescription Release requirement and the accompanying recordkeeping
provision shall not apply to prescribers who do not have a direct or
indirect financial interest in the sale of eyeglasses, including, but
not limited to, through an association, affiliation, or co-location
with a prescription-eyewear seller. 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?
13. Does the Contact Lens Rule's Confirmation of Prescription
Release requirement reduce or increase the need for a similar
requirement for the Eyeglass Rule?
14. What evidence supports your answers?
D. Electronic Delivery of Prescriptions:
1. The Commission believes that providing patients with a digital
copy of their prescription, in lieu of a paper copy, would satisfy the
automatic prescription release requirement (Sec. 456.2) if the patient
gives verifiable affirmative consent and is able to access, download,
and print the prescription. The Commission seeks comment on the
benefits or the burdens that the option to provide electronic delivery
of prescriptions would confer.
2. Would prescribers choose to satisfy the automatic prescription
release requirement through electronic delivery if permitted by the
Rule?
3. Would a patient portal, email, or text message be feasible
methods for prescribers to provide digital copies of prescriptions to
patients? Are prescribers using any other electronic methods to provide
patients with prescriptions?
4. What other technologies are available that could be implemented
to improve prescription portability and thereby increase benefits and
decrease burdens related to prescription release?
5. What evidence supports your answers?
E. Insurance as Payment
1. The Commission believes that it would be appropriate to amend
the Eyeglass Rule to clarify that a patient's presentation of proof of
insurance coverage shall be deemed to constitute a payment for purposes
of determining when a prescription must be provided under 16 CFR
456.2(a). The Commission seeks comment on the benefits or the burdens
that this clarification would confer.
2. Would clarifying that presentation of proof of insurance
coverage shall be deemed to constitute a payment under Sec. 456.2(a)
increase, decrease, or have no effect on compliance with the Rule's
requirement that patients receive a copy of their prescription after
the completion of a refractive eye examination? Why?
3. Would clarifying that presentation of proof of insurance
coverage shall be deemed to constitute a payment under Sec. 456.2(a)
increase, decrease, or have no effect on the Commission's ability to
enforce, and monitor compliance with, the Rule's automatic prescription
release provision? Why?
4. Would clarifying that presentation of proof of insurance
coverage shall be deemed to constitute a payment under Sec. 456.2(a)
increase, decrease, or have no effect on the extent to which patients
understand their rights under the Rule? Why?
5. What evidence supports your answers?
F. Eye Examination Term
1. Would changing the term ``eye examination'' throughout the Rule
to ``refractive eye examination'' increase, decrease, or have no effect
on compliance with the Rule's requirement that patients receive a copy
of their prescription after the completion of a refractive eye
examination? Why?
2. Would changing the term''eye examination'' throughout the Rule
to ``refractive eye examination'' increase, decrease, or have no effect
on the Commission's ability to enforce, and monitor compliance with,
the Rule's automatic prescription release provision? Why?
3. Would changing the term ``eye examination'' throughout the Rule
to ``refractive eye examination'' increase, decrease, or have no effect
on the extent to which patients understand their rights under the Rule?
Why?
4. Would using the term ``refractive eye examination'' in place of
``eye examination'' help avoid confusion over when the prescriber must
release the prescription, and whether prescribers may withhold release
of the prescription subject to any charges other than the one due for
the refractive eye examination?
5. Is the current definition in the Rule, namely ``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,'' a
clear and accurate way of describing a refractive eye examination?
6. Would using the term ``refractive eye examination'' in place of
``eye examination'' have any other consequences for eye care, positive
or negative?
7. What evidence supports your answers?

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

Pursuant to FTC Rule Sec. 1.18(c)(1)(i)-(ii), the Commission has
determined that communications with respect to the merits of this
proceeding from any outside party to any Commissioner or Commissioner
advisor shall be subject to the following treatment. Written
communications and summaries or transcripts of oral communications
shall be placed on the rulemaking record if the communication is
received before the end of the public comment period in response to
this NPRM. They shall be placed on the public record if the
communication is received later. Unless the outside party making an
oral communication is a member of Congress, such communications are
permitted only if advance notice is published in the Weekly Calendar
and Notice of Sunshine Meetings.\434\
---------------------------------------------------------------------------

\434\ See 15 U.S.C. 57a(i)(2)(A); 16 CFR 1.18(c).
---------------------------------------------------------------------------

IX. Paperwork Reduction Act

The Paperwork Reduction Act (``PRA''), 44 U.S.C. 3501 et seq.,
requires federal agencies to obtain Office of Management and Budget
(``OMB'') approval before undertaking a collection of information
directed to ten or more persons. Pursuant to the regulations
implementing the Paperwork Reduction Act,\435\ an agency may not
collect or sponsor the collection of information, nor may it impose an
information collection requirement unless it displays a currently valid
OMB control number.
---------------------------------------------------------------------------

\435\ 5 CFR 1320.8(b)(2)(vi).
---------------------------------------------------------------------------

The Commission is proposing a number of modifications to the Rule
that contain recordkeeping requirements that are collections of
information as defined by OMB regulations that implement the PRA.
First, the Commission is proposing to modify the Rule to require that
prescribers either: (i) obtain from patients, and maintain for a period
of not less than three years, a signed confirmation of prescription
release on a separate stand-alone document; (ii) obtain from patients,
and maintain for a period of not less than three years, a patient's
signature on a confirmation of

[[Page 282]]

prescription release included on a copy of a patient's prescription;
(iii) obtain from patients, and maintain for a period of not less than
three years, a patient's signature on a confirmation of prescription
release included on a copy of a patient's refractive eye examination
sales receipt; or (iv) provide each patient with a copy of the
prescription via online portal, electronic mail, or text message, and
for three years retain evidence that such prescription was sent,
received, or made accessible, downloadable, and printable by the
patient. For prescribers who choose to offer an electronic method of
prescription delivery, the proposed Rule would require that such
prescribers identify the specific method or methods to be used, and
maintain records or evidence of affirmative consent by patients to such
digital delivery for three years. For instances where a consumer
refuses to sign the confirmation or accept digital delivery of their
prescription, the proposed Rule directs the prescriber to note the
refusal and preserve this record as evidence of compliance. None of the
proposed new requirements, however, would apply to prescribers who do
not have a direct or indirect financial interest in the sale of
eyeglasses.
The Commission hereby provides PRA burden estimates, analysis, and
discussion for the burden of automatically releasing a prescription at
the completion of a refractive eye exam, as well as the proposed
requirement to collect patient signatures as confirmation of
prescription release and as consent to electronic prescription
delivery. Commission staff estimates these PRA burdens based on its
long-standing knowledge and experience with the eye care industry.\436\
The Commission is submitting these proposed amendments and a Supporting
Statement to OMB for review.
---------------------------------------------------------------------------

\436\ See Section I.B, supra.
---------------------------------------------------------------------------

A. Estimated Burden

The number of adult eyeglass wearers in the United States is
currently estimated to be approximately 165 million.\437\ Assuming a
biennial refractive eyeglass exam for each eyeglass wearer,\438\
approximately 82.5 million people would receive a copy of their
eyeglass prescription every year. Historically, the Commission has
estimated that it takes one minute to provide the patient with a
prescription copy, and that it is the prescriber, and not the
prescriber's office staff, that provides the prescription to the
consumer.\439\ We therefore estimate an annual disclosure burden for
prescribers of approximately 1,375,000 hours (82.5 million annual exams
x 1 min/60 mins).
---------------------------------------------------------------------------

\437\ See VisionWatch Report, supra note 70, at 24.
\438\ The Commission relies on industry sources for its estimate
that eyeglass wearers typically obtain one refractive eye exam every
two years. See, e.g., AOA, Excel and Jobson Medical Information, The
State of the Optometric Profession: 2013, at 4, https://www.reviewob.com/wp-content/uploads/2016/11/8-21-13stateofoptometryreport.pdf (showing an average interval between
exams of 25 months); AOA, Comprehensive Eye Exams, https://www.aoa.org/healthy-eyes/caring-for-your-eyes/eye-exams?sso=y
(showing recommended examination frequency for adult patients 18-64
of ``at least every two years'' for asymptomatic/low risk patients).
In contrast to the CLR, which establishes a one-year minimum term
for most contact lens prescriptions (16 CFR 315.6(a)) (a term-length
mirrored by a majority of states, see CLR NPRM, 81 FR 88526, 88545,
n.245), the Eyeglass Rule does not discuss or define prescription
expiration terms, and many states do not set any limit for eyeglass
prescriptions. See note 399, supra (summarizing a number of state
laws that allow eyeglass prescriptions to be valid for periods
longer than one year). Some eyeglass wearers, therefore, can legally
go many years between refractive eye examinations. But the
Commission will use two years as a basis for purposes of this
assessment, since that is recommended interval for the majority of
eyeglass wearers.
\439\ It is quite possible that one minute is an overestimate of
the amount of time required, and that in practice, this task takes
less time and is often performed by office staff rather than the
prescriber. As of now, however, we have not seen conclusive evidence
to justify making a change to the approach we have repeatedly taken
in the past. See, e.g., CLR SNPRM, 84 FR 24664, 24693 n.347.
---------------------------------------------------------------------------

Staff anticipates there will be an additional burden on individual
prescribers' offices to maintain signed confirmation forms for a period
of not less than three years, but believes the overall burden imposed
by the Rule remains relatively small in the context of the overall
market for eyeglasses and refractive examinations. Based on the
Commission's assumption of the number of refractive eye examinations
that occur annually, staff estimates that 82.5 million people would
either read and sign a confirmation of prescription release, or sign a
confirmation agreeing to receive their prescription electronically
every year.
The Commission believes that generating and presenting the
confirmation of prescription release will not require significant time
or effort. The proposed requirement is flexible in that it allows any
one of several different modalities and delivery methods, including
adding the confirmation to existing documentation that prescribers
routinely provide (sales receipts) or are already required to provide
(prescriptions) to patients. The proposed requirement is also flexible
in that it does not prescribe other details, such as the precise
content or language of the patient confirmation, but merely requires
that, if provided to the patient pursuant to options specified in Sec.
456.3(a)(1), the confirmation from the patient must be in writing. At
the same time, prescribers would not have to spend time formulating
their own content for the confirmation, since the proposed Rule
provides draft language that prescribers are free to use, should they
so desire.
The four options for a prescriber to confirm a prescription release
to a patient are set out in proposed Sec. 456.3(a)(1)(i), (ii), (iii),
and (iv). The requirement in options Sec. 456.3(a)(1)(i), (ii), and
(iii) to provide the patient with a confirmation of prescription
release are not disclosures constituting an information collection
under the PRA because the FTC, in Sec. 456.3(a)(2), has supplied the
prescriber with draft language the prescriber can use to satisfy this
requirement.\440\ As noted above, however, the requirement in (i),
(ii), and (iii) to collect a patient's signature on the confirmation of
prescription release and preserve it constitutes an information
collection as defined by OMB regulations that implement the PRA.
Nonetheless, the Commission believes it will require minimal time for a
patient to read the confirmation and provide a signature. The
Commission estimated in the Contact Lens Rule that it would take
patients ten seconds to read the one-sentence confirmation of
prescription release and provide a signature,\441\ and the Commission
believes that ten seconds is an appropriate estimate for the Eyeglass
Rule confirmation as well.
---------------------------------------------------------------------------

\440\ ``The public disclosure of information originally supplied
by the Federal government to the recipient for the purpose of
disclosure to the public is not included within'' the definition of
``collection of information.'' 5 CFR 1320.3(c)(2). It is also
notable that for the options in proposed Sec. Sec. 456.3(a)(1)(ii)
and (iii), the confirmation information would be printed on the same
document--the prescription copy or sales receipt--that the
prescriber would ordinarily provide to the consumer in any event.
\441\ CLR Final Rule, 85 FR 50668, 50709. This estimate was
based on responses to a consumer survey regarding how long it would
take consumers to read the form, and a prior PRA estimate for
consumers to complete a similar signed acknowledgment. See CLR
SNPRM, 84 FR 24664, 24693.
---------------------------------------------------------------------------

The fourth proposed option, Sec. 456.3(a)(1)(iv), does not, in and
of itself, constitute an information collection under the PRA, since no
new information that would not otherwise be provided under the Rule is
provided to or requested from the patient.\442\ Excluding that option
from

[[Page 283]]

consideration, and assuming the remaining three options are exercised
with equal frequency, 75% of approximately 82.5 million annual
prescription releases will entail reading and signing a confirmation
statement. Thus, assuming ten seconds for each release, prescribers
would devote 171,875 hours, cumulatively (75% x 82.5 million
prescriptions yearly x 10 seconds each/60secs/60mins) to obtaining
patient signatures as confirmations of prescription release.\443\
---------------------------------------------------------------------------

\442\ In order to utilize Sec. 456.3(a)(1)(iv), however, a
prescriber must obtain and maintain records or evidence of
affirmative consent by patients to electronic delivery of their
prescriptions. 16 CFR 456.1(h)(2). The burden to do so is included
in the recordkeeping burden calculation of this PRA Section.
\443\ Section 456.3(a)(3) also requires that in the event that a
patient declines to sign a confirmation requested under paragraphs
(a)(1)(i), (ii), or (iii), the prescriber must note the patient's
refusal on the document and sign it. However, the Commission has no
reason to believe that such notation should take any longer than for
the patient to read and sign the document, so the Commission will
maintain its calculation as if all confirmations requested under
(a)(1)(i), (ii), or (iii) require the same amount of time.
---------------------------------------------------------------------------

Maintaining those signed confirmations for a period of not less
than three years should also not impose substantial new burdens on
individual prescribers and office staff. The majority of states already
require that optometrists keep records of eye examinations for at least
three years,\444\ and thus many prescribers who opt to include the
confirmation of prescription release on the prescription itself would
be preserving that document, regardless. Similarly, most prescribers
already retain customer sales receipts for financial accounting and
recordkeeping purposes, and thus prescribers who opt to include the
confirmation of prescription release on the sales receipt also could be
retaining that document, regardless. Moreover, storing a one-page
document per patient per year should not require more than a few
seconds, and an inconsequential, or de minimis, amount of record space.
Some prescribers might also present the confirmation of prescription
release in electronic form, enabling patients to sign a computer screen
or tablet directly, and have their confirmation immediately stored as
an electronic document.
---------------------------------------------------------------------------

\444\ See, e.g., 246 Mass. Code Regs. Sec. 3.02 (requiring
optometrists to maintain patient records for at least seven years);
Wash. Admin. Code Sec. 246-851-290 (requiring optometrists to
maintain records of eye exams and prescriptions for at least five
years); Iowa Admin. Code r. 645-182.2(2) (requiring optometrists to
maintain patient records for at least five years).
---------------------------------------------------------------------------

For other prescribers, the proposed recordkeeping requirement would
likely require that office staff either preserve the confirmation in
paper format, or electronically scan the signed confirmation and save
it as an electronic document. For prescribers who preserve the
confirmation electronically by scanning it, Commission staff estimates
that saving such a document would consume approximately one minute of
staff time. Commission staff does not possess detailed information on
the percentage of prescribers' offices that currently use and maintain
paper forms or electronic forms, or that scan paper files and maintain
them electronically. Thus, for purposes of this PRA analysis,
Commission staff will assume that all prescriber offices who opt for
Sec. 456.3(a)(1)(i), (ii), or (iii) require a full minute per
confirmation for recordkeeping arising from the modifications.
Excluding from PRA consideration the fourth option, Sec.
456.3(a)(1)(iv), as there is no signature to obtain or retain, and
assuming that prescribers elect the other options three-fourths or 75%
of the time, the recordkeeping burden for all prescribers' offices to
scan and save such confirmations would amount to 1,031,250 hours (75% x
82.5 million prescriptions yearly x one minute for scanning and
storing/60mins) per year.
As noted previously, the fourth option for satisfying the
confirmation of prescription release requirement does not necessitate
that prescribers obtain or maintain a record of the patient's signature
confirming receipt of her prescription. However, as explained in Sec.
456.1(h)(2), under the Rule's new proposed definition of Provide to the
patient one copy, in order to avail themselves of the fourth option,
prescribers must obtain and maintain records or evidence of the
patients' affirmative consent to electronic delivery for three years.
The Commission will use the assumption that consumers sign such
consents for electronic delivery pursuant to Sec. 456.3(a)(1)(iv), for
one quarter of the 82.5 million prescriptions released per year,\445\
and that this task would take the same amount of time as to obtain and
maintain a signature of the patient's confirmation of prescription
release. Thus, the Commission will allot 401,042 hours \446\ for the
time required for prescribers to obtain patients' affirmative consent
to electronic delivery of their prescriptions and maintain records of
same.
---------------------------------------------------------------------------

\445\ 20,625,000 prescriptions (82.5 million prescriptions x
25%).
\446\ 57,292 hours (20,625,000 prescriptions yearly x 10
seconds/60secs/60mins) for obtaining the signature plus 343,750
hours (20,625,000 affirmative consents x one minute/60mins) for
storing such records.
---------------------------------------------------------------------------

Therefore, the estimated incremental PRA recordkeeping burden for
prescribers and their staff resulting from the confirmation of
prescription release modifications to the Rule amounts to 1,604,167
total hours (171,875 and 57,292 hours, respectively, to obtain
signatures confirming release and consenting to electronic delivery,
plus 1,031,250 and 343,750 hours, respectively, to maintain records of
confirmation and consent for three years). Adding the estimated
incremental PRA recordkeeping burden for prescribers and their staff
from the confirmation of prescription release proposal to the burden
from the requirement that prescribers provide patients with copies of
their prescriptions yields a total disclosure and recordkeeping burden
from the Rule of 2,979,167 hours for prescribers and their staff
(1,375,000 disclosure hours + 1,604,167 recordkeeping hours).

B. Estimated Labor Cost

Commission staff derives labor costs by applying appropriate
hourly-cost figures to the burden hours described above. The task to
obtain patient confirmations and consent to electronic delivery could
theoretically be performed by medical professionals (e.g.,
optometrists, ophthalmologists) or their support staff (e.g.,
dispensing opticians, medical technicians, office clerks). In its
Contact Lens Rule review, the Commission requested comment as to
whether prescribers or office staff are more likely to collect patient
signatures and retain associated recordkeeping, but did not receive
significant guidance on this.\447\ Therefore, the Commission will
continue to assume that optometrists will perform the task of
collecting patient signatures, and that prescribers' office staff will
perform the labor pertaining to printing, scanning, and storing of
documents, even though these assumptions may lead to some overcounting
of the burden (if, in actuality, prescribers' office staff obtain
patient signatures).
---------------------------------------------------------------------------

\447\ CLR Final Rule, 85 FR 50668, 50710.
---------------------------------------------------------------------------

According to the U.S. Bureau of Labor Statistics, salaried
optometrists earn an average wage of $60.31 per hour, and general
office clerks earn an average wage of $18.75 per hour.\448\ Using the
aforementioned estimate of 229,167 total prescriber labor hours for
obtaining patient signatures, the resultant aggregate labor costs to
obtain patient signatures is $13,821,062 (229,167 hours x $60.31).
Applying a mean hourly wage for office clerks of $18.75 per hour to the
aforementioned estimate of 1,375,000 hours for printing, scanning and
storing of prescription release confirmations and consent agreements,

[[Page 284]]

labor costs for those tasks would total $25,781,250. Therefore,
combining the aggregate labor costs for both prescribers and office
staff to obtain signed patient confirmations and consent to electronic
delivery and preserve the associated records, the Commission estimates
the total annual labor burden of the confirmation of prescription
release modification to be $39,602,312.
---------------------------------------------------------------------------

\448\ Bureau of Labor Statistics, United States Department of
Labor, Occupational Employment Statistics, https://www.bls.gov/news.release/ocwage.t01.htm.
---------------------------------------------------------------------------

Adding the $39,602,312 burden from the confirmation of prescription
release requirement to the $82,926,250 burden \449\ from the
prescription release requirement already in place yields a total
estimated annual labor cost burden for the Eyeglass Rule of
$122,528,562. While not insubstantial, this amount constitutes
approximately one half of one percent of the estimated overall retail
market for eyeglass sales in the United States.\450\ Furthermore, the
actual burden is likely to be less, because many prescribers' offices
will require less than a minute to store the confirmation form.
---------------------------------------------------------------------------

\449\ 1,375,000 hours x $60.31 (average hourly wage for
optometrists) = $82,926,250.
\450\ According to The Vision Council, the eyeglass market (for
frames and lenses) in the United States for the twelve months ending
December 2019, totaled roughly $24.3 billion. See VisionWatch
Report, supra note 70, at 69, 89; Vision Council, ``Consumer
Barometer,'' Dec. 2019, at 18-19. The estimated total burden of the
Rule of $122,528,562 thus amounts to approximately 0.5 percent of
the total market.
---------------------------------------------------------------------------

C. Capital and Other Non-Labor Costs

The proposed recordkeeping requirements detailed above regarding
prescribers impose negligible capital or other non-labor costs, as
prescribers likely have already the necessary equipment and supplies
(e.g., prescription pads, patients' medical charts, scanning devices,
recordkeeping storage) to perform those requirements.
The Commission invites comments on: (1) whether the proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information shall
have practical utility; (2) the accuracy of the FTC's burden estimates,
including whether the methodology and assumptions used are valid; (3)
ways to enhance the quality, utility, and clarity of the information to
be collected; and (4) ways to minimize the burden of collecting
information.
Written comments and recommendations for the proposed information
collection should be sent within 30 days of publication of this
document to www.reginfo.gov/public/do/PRAMain. Find this particular
information collection by selecting ``Currently under Review--Open for
Public Comments'' or by using the search function. The reginfo.gov web
link is a United States Government website produced by OMB and the
General Services Administration (``GSA''). Under PRA requirements,
OMB's Office of Information and Regulatory Affairs reviews federal
information collections.

X. Preliminary Regulatory Analysis and Regulatory Flexibility Act
Requirements

Under section 22 of the FTC Act, 15 U.S.C. 57b-3, the Commission
must issue a preliminary regulatory analysis for a proceeding to amend
a rule only when it: (1) estimates that the amendment will have an
annual effect on the national economy of $100,000,000 or more; (2)
estimates that the amendment will cause a substantial change in the
cost or price of certain categories of goods or services; or (3)
otherwise determines that the amendment will have a significant effect
upon covered entities or upon consumers. For the reasons explained
below, in the PRA section above, and in the main text of this document,
the Commission has preliminarily determined that the proposed
amendments will not have such effects on the national economy; on the
cost of eye examinations or prescription eyeglasses; or on covered
parties or consumers. The Commission, however, requests comment on the
economic effects of the proposed amendments.
The Regulatory Flexibility Act (``RFA''), 5 U.S.C. 601 et seq.,
requires the Commission to conduct an analysis of the anticipated
economic impact of the proposed amendments on small entities. The
purpose of a regulatory flexibility analysis is to ensure the agency
considers the impacts on small entities and examines alternatives that
could achieve the regulatory purpose while minimizing burdens on small
entities. Section 605 of the RFA provides that such an analysis is not
required if the agency head certifies that the regulatory action will
not have a significant economic impact on a substantial number of small
entities.
The Commission does not anticipate that the proposed amendments
will have a significant economic impact on small entities, although
they may affect a substantial number of small businesses. The proposed
amendments would require that prescribers obtain from patients, and
maintain for a period of not less than three years, a signed
confirmation of prescription release, acknowledging that patients
received their eyeglass prescriptions at the completion of their
refractive eye examination. The new proposals would also require some
prescribers to obtain and maintain for three years a patient's consent
to deliver prescriptions electronically, but only for prescribers who
elect to offer this method of delivery as an alternative to providing
prescriptions in paper, and only if the patient agrees.
As described in the PRA section of this document, the Commission
approximates that collecting a patient's signature on the confirmation
of prescription release (giving time for patient to read confirmation)
in accordance with Sec. 456.3(a)(1)(i), (ii), and (iii) will take
approximately ten seconds. Providing the patient with the confirmation
of prescription release in accordance with this provision will require
prescribers' offices to present a form, receipt, or prescription and
request a patient signature. The proposed amendments to the Rule
provide prescribers with the language that they can use on a
confirmation form, which will relieve prescribers of that burden, and a
request to sign such confirmation will take a de minimis amount of
time. This requirement may also involve some staff training, which the
Commission believes will be minimal. As a result, the Commission
believes that complying with Sec. 456.3(a)(1)(i), (ii), and (iii))
will impose only minimal costs upon prescriber offices, but requests
information about the associated costs and burdens.
The PRA section of this document addresses the burden for
prescribers to maintain records of confirmation of receipt of
prescriptions for at least three years, noting that the majority of
states already require that optometrists keep records of eye
examinations for at least three years, and estimating a full minute for
prescribers to meet their recordkeeping obligations. Prescribers who
decide to collect or maintain signatures electronically may already
have electronic health records systems in place, but the Commission
requests information on costs prescribers are likely to incur to comply
with the recordkeeping proposals in this document.
In addition, the proposal to permit prescribers to deliver
prescriptions electronically would require prescribers to obtain, and
maintain for three years, a patient's consent to electronic
prescription delivery. This requirement can be avoided altogether
should a prescriber not wish to provide patients this option.
Furthermore, whenever a prescriber enables a patient to receive a
prescription electronically, this relieves the prescriber of the burden
to obtain a signed prescription release confirmation

[[Page 285]]

from that patient. However, as explained in Sec. 456.1(h)(2), under
the Rule's new definition of Provide to the patient one copy, to avail
themselves of the fourth option, prescribers must obtain and maintain
records or evidence of the patients' affirmative consent to electronic
delivery for three years. The PRA section of this document assumed that
this task would take one minute and ten seconds, the same amount of
time as to obtain and maintain a signature of the patient's
confirmation of prescription release. The Commission requests
information on costs that may be incurred by prescribers to comply with
this option for prescription delivery.
Although the proposed amendments will impose a small burden upon
prescribers, the proposed amendments should not have a significant or
disproportionate impact on prescribers' costs. Therefore, based on
available information, the Commission certifies that amending the Rule
as proposed will not have a significant economic impact on a
substantial number of small businesses.
Although the Commission certifies under the RFA that the proposed
amendments, if promulgated, will not have a significant impact on a
substantial number of small entities, the Commission has nonetheless
determined it is appropriate to publish an Initial Regulatory
Flexibility Analysis to inquire into the impact of the proposed
amendments on small entities. Therefore, the Commission has prepared
the following analysis:

B. Description of the Reasons the Agency Is Taking Action

In response to public comments, the Commission proposes amending
the Rule to ensure that patients are receiving a copy of their eyeglass
prescription at the completion of a refractive eye examination.

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

The objective of the proposed amendments is to clarify and update
the Rule in accordance with marketplace practices. The Commission
promulgated the Rule pursuant to section 18 of the FTC Act, 15 U.S.C.
57a. As noted earlier, the Commission has wide latitude in fashioning a
remedy and need only show a ``reasonable relationship'' between the
unfair or deceptive act at issue and the remedy.\451\ The proposed
amendments to the Rule requiring that prescribers obtain from patients,
and maintain for a period of not less than three years, a signed
confirmation of patients' receipt of their eyeglass prescriptions,
permitting prescribers to comply with automatic prescription release
via electronic delivery in certain circumstances, clarifying 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 under 16 CFR 456.2(a), and replacing the term ``eye
examination'' with ``refractive eye examination,'' are reasonably
related to remedying the unfair practices that led the Commission to
promulgate the Rule.
---------------------------------------------------------------------------

\451\ Am. Fin. Servs. Ass'n v. FTC, 767 F.2d at 988 (quoting
Jacob Siegel Co. v. FTC, 327 U.S. 608, 612-13 (1946)).
---------------------------------------------------------------------------

D. Small Entities to Which the Proposed Amendments Will Apply

The proposed amendments apply to prescribers of eyeglasses. The
Commission believes that many prescribers will fall into the category
of small entities (e.g., offices of optometrists less than $8 million
in size).\452\ Determining a precise estimate of the number of small
entities covered by the Rule's prescription release requirements is not
readily feasible because most prescribers' offices do not release the
underlying revenue information necessary to make this
determination.\453\ Based on its knowledge of the eye care industry,
including meetings with industry members and a review of industry
publications, staff believes that a substantial number of these
entities likely qualify as small businesses.\454\ The Commission seeks
comment with regard to the estimated number or nature of small business
entities, if any, for which the proposed amendments would have a
significant impact.
---------------------------------------------------------------------------

\452\ See 13 CFR 121.201 (Small Business Size Regulations).
\453\ 5 U.S.C. 601(6).
\454\ According to one publication, 65 percent of optometrists
work in a practice owned by an optometrist or ophthalmologist,
practices that are likely small businesses. See AOA, ``An Action-
Oriented Analysis of the State of the Optometric Profession: 2013,''
at 7, https://documents.aoa.org/Documents/news/state_of_optometry.pdf. This publication also reported that although
it could not ascertain the precise number of independent optometric
practices, it estimated that as of 2012, there were 14,000 to 16,000
optometric businesses with no corporate or institutional
affiliation. Id.
---------------------------------------------------------------------------

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

As explained earlier in this document, the proposed amendments
require that prescribers obtain from patients, and maintain for a
period of not less than three years (in paper or electronic form), a
signed confirmation of prescription release, acknowledging that
patients received their eyeglass prescriptions at the completion of
their refractive eye examination. The amendments also permit
prescribers to comply with automatic prescription release via
electronic delivery in certain circumstances, 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 under 16 CFR 456.2(a), and replace the term ``eye
examination'' with ``refractive eye examination'' throughout the Rule.
The small entities potentially covered by these proposed amendments
will include all such entities subject to the Rule. The professional
skills necessary for compliance with the Rule as modified by the
proposed amendments will include office and administrative support
supervisors to create the confirmation form and clerical personnel to
collect signatures from patients and maintain records. Compliance may
include some minimal training time as well.\455\ The Commission
believes the burden imposed on small businesses by these requirements
is relatively small, for the reasons described previously in this
section as well as the PRA section of this document. The Commission
invites comment and information on these issues, including estimates or
data on specific compliance costs that small entities might be expected
to incur.
---------------------------------------------------------------------------

\455\ The Commission does not believe it will require
significant training to learn when and how to obtain a patient
signature and preserve it, particularly since prescribers' office
staff will already know how to perform these tasks, due to similar
signature requirements already in place for the Contact Lens Rule
and the HIPAA NPP, among others.
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F. Duplicative, Overlapping, or Conflicting Federal Rules

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

[[Page 286]]

three years. Further, as discussed elsewhere in this NPRM, HIPAA, the
21st Century Cures Act, and state laws provide consumers with a right
of access to medical records, though the parameters and timing involved
with access are different than the Eyeglass Rule.\456\ The Commission
also notes that prescribers may reduce any burden associated with the
proposed amendments by using the same mechanism to obtain confirmation
of receipt of a contact lens prescription (in accordance with the
Contact Lens Rule) and an eyeglass prescription in cases when the
prescriber provides both prescriptions to the patient at the same time,
so long as the prescriber asks for separate signatures for each. The
Commission invites additional comment on the issue of duplicative,
overlapping or conflicting federal rules.
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\456\ Prescribers may have EHRs in place to comply with these
laws, as well as having certified health information technology to
receive direct payments per the HITECH Act. The fact that
prescribers' offices have EHRs and health information technology may
make it less costly or burdensome for prescribers to comply with the
proposed amendments to the Eyeglass Rule.
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G. Significant Alternatives to the Proposed Amendments

The Commission has not proposed any specific small entity exemption
or other significant alternatives, as the proposed amendments clarify
and update the Rule in light of marketplace practices to ensure that
patients are receiving a copy of their eyeglass prescription at the
completion of a refractive eye examination. Under these limited
circumstances, the Commission does not believe a special exemption for
small entities or significant compliance alternatives are necessary or
appropriate to minimize the compliance burden, if any, on small
entities while achieving the intended purposes of the proposed
amendments. As discussed above, the proposed recordkeeping requirement
likely involves minimal burden and prescribers would be permitted to
maintain records in either paper or electronic format. This
recordkeeping burden could be reduced to the extent that prescribers
have adopted electronic medical record systems, especially those where
patient signatures can be recorded electronically and inputted
automatically into the electronic record. Furthermore, prescribers also
could scan signed paper copies of the confirmation and store those
confirmations electronically to lower the costs of this recordkeeping
requirement. Similarly, when using a text message, electronic mail, or
an online patient portal to satisfy the prescription release
requirement (assuming the patient's consent), prescribers may provide
the required copy of the prescription electronically (i.e., digital
format). Nonetheless, the Commission seeks comment on the need, if any,
for alternative compliance methods to reduce the economic impact of the
Rule on small entities. If the comments filed in response to this NPRM
identify small entities affected by the proposed amendments, as well as
alternative methods of compliance that would reduce the economic impact
of the proposed amendments on such entities, the Commission will
consider the feasibility of such alternatives and determine whether
they should be incorporated into the final rule.

Proposed Rule Language

List of Subjects in 16 CFR Part 456

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

For the reasons set out in the preamble, the Federal Trade
Commission proposes to amend 16 CFR part 456 to read as follows:

PART 456--OPHTHALMIC PRACTICE RULES (EYEGLASS RULE)

0
1. Revise the authority citation for part 456 to read as follows:

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

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

Sec. 456.1 Definitions.

(a) A patient is any person who has had a refractive eye
examination.
(b) A refractive eye examination is the process of determining the
refractive condition of a person's eyes or the presence of any visual
anomaly by the use of objective or subjective tests.
* * * * *
(d) Ophthalmic services are the measuring, fitting, and adjusting
of ophthalmic goods subsequent to a refractive eye examination.
(e) An ophthalmologist is any Doctor of Medicine or Osteopathy who
performs refractive eye examinations.
* * * * *
(g) A prescription is the written specifications for lenses for
eyeglasses which are derived from a refractive eye examination,
including all of the information specified by state law, if any,
necessary to obtain lenses for eyeglasses.
(h) Provide to the patient one copy means giving a patient a copy
of his or her prescription:
(1) On paper; or
(2) In a digital format that can be accessed, downloaded, and
printed by the patient. For a copy provided in a digital format, the
prescriber shall identify to the patient the specific method or methods
of electronic delivery to be used, such as text message, electronic
mail, or an online patient portal, and obtain 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. Such
records or evidence shall be available for inspection by the Federal
Trade Commission, its employees, and its representatives.
0
3. Revise Sec. 456.2 to read as follows:

Sec. 456.2 Separation of examination and dispensing.

It is an unfair act or practice for an ophthalmologist or
optometrist to:
(a) Fail to provide to the patient one copy of the patient's
prescription immediately after the refractive eye examination is
completed. Provided: An ophthalmologist or optometrist may refuse to
give the patient a copy of the patient's prescription until the patient
has paid for the refractive eye examination, but only if that
ophthalmologist or optometrist would have required immediate payment
from that patient had the examination revealed that no ophthalmic goods
were required. For purposes of the preceding sentence, the presentation
of proof of insurance coverage for that service shall be deemed to be a
payment;
(b) Condition the availability of a refractive eye examination to
any person on a requirement that the patient agree to purchase any
ophthalmic goods from the ophthalmologist or optometrist;
(c) Charge the patient any fee in addition to the ophthalmologist's
or optometrist's refractive eye examination fee as a condition to
releasing the prescription to the patient. Provided: An ophthalmologist
or optometrist may charge an additional fee for verifying ophthalmic
goods dispensed by another seller when the additional fee is imposed at
the time the verification is performed; or
(d) Place on the prescription, or require the patient to sign, or
deliver to the patient a form or notice waiving or disclaiming the
liability or responsibility of the ophthalmologist or optometrist for
the accuracy of the refractive eye examination or the accuracy of the
ophthalmic goods and services dispensed by another seller.
0
4. Revise Sec. 456.3 to read as follows:

[[Page 287]]

Sec. 456.3 Confirmation of prescription release.

(a)(1) Upon completion of a refractive eye examination, and after
providing a copy of the prescription to the patient, the prescriber
shall do one of the following:
(i) 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
the 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 refractive eye 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.
(2) If the prescriber elects to confirm prescription release via
paragraphs (a)(1)(i), (ii), or (iii) of this section, the prescriber
may, but is not required to, use the statement, ``My eye care
professional provided me with a copy of my prescription at the
completion of my examination'' to satisfy the requirement.
(3) In the event the patient declines to sign a confirmation
requested under paragraphs (a)(1)(i), (ii), or (iii) of this section,
the prescriber shall note the patient's refusal on the document and
sign it.
(b) A prescriber shall maintain the records or evidence required
under paragraph (a) of this section for a period of not less than three
years. Such records or evidence shall be available for inspection by
the Federal Trade Commission, its employees, and its representatives.
(c) Paragraphs (a) and (b) of this section shall not apply to
prescribers who do not have a direct or indirect financial interest in
the sale of eye wear, including, but not limited to, through an
association, affiliation, or co-location with an optical dispenser.

Sec. Sec. 456.3 through 456.5 [Redesignated]

0
5. Redesignate Sec. Sec. 456.3 through 456.5 as Sec. Sec. 456.4
through 456.6.

Sec. 456.3 [Reserved]

0
6. Add and reserve a new Sec. 456.3.

By direction of the Commission.
April J. Tabor,
Secretary.
[FR Doc. 2022-27828 Filed 12-30-22; 8:45 am]
BILLING CODE 6750-01-P