Proposed Rule2022-27828
Ophthalmic Practice Rules (Eyeglass Rule)
Primary source
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Published
January 3, 2023
Issuing agencies
Federal Trade Commission
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 1 (Tuesday, January 3, 2023)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-27828]
[[Page 247]]
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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
[[Page 249]]
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), <a href="https://www.ftc.gov/reports/staff-report-advertising-ophthalmic-goods-services-proposed-trade-regulation-rule-16-cfr-part-456?msclkid=957f749bc63711ecaefb4944debc75db">https://www.ftc.gov/reports/staff-report-advertising-ophthalmic-goods-services-proposed-trade-regulation-rule-16-cfr-part-456?msclkid=957f749bc63711ecaefb4944debc75db</a> [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,
[[Page 250]]
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), <a href="https://www.ftc.gov/reports/state-restrictions-vision-care-providers-effects-consumers-eyeglasses-ii">https://www.ftc.gov/reports/state-restrictions-vision-care-providers-effects-consumers-eyeglasses-ii</a>
\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), <a href="https://www.ftc.gov/reports/ophthalmic-practice-rules-state-restrictions-commercial-practice-eyeglasses-ii-report-staff">https://www.ftc.gov/reports/ophthalmic-practice-rules-state-restrictions-commercial-practice-eyeglasses-ii-report-staff</a> [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), <a href="https://www.ftc.gov/reports/report-presiding-officer-proposed-trade-regulation-rule-ophthalmic-practice-rules-eyeglass-rule-16?msclkid=c8131b8ac63911ecb89f5b16ef81c791">https://www.ftc.gov/reports/report-presiding-officer-proposed-trade-regulation-rule-ophthalmic-practice-rules-eyeglass-rule-16?msclkid=c8131b8ac63911ecb89f5b16ef81c791</a>.
\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
[[Page 251]]
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,'' <a href="https://www.aao.org/newsroom/eye-health-statistics">https://www.aao.org/newsroom/eye-health-statistics</a>.
\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), <a href="https://www.aao.org/eye-health/tips-prevention/ophthalmology-subspecialists">https://www.aao.org/eye-health/tips-prevention/ophthalmology-subspecialists</a>.
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[[Page 252]]
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?''
<a href="https://www.aoa.org/healthy-eyes/whats-a-doctor-of-optometry?sso=y">https://www.aoa.org/healthy-eyes/whats-a-doctor-of-optometry?sso=y</a>.
\65\ Bureau of Labor Statistics, U.S. Dep't of Labor,
Occupational Outlook Handbook, Optometrists, <a href="https://www.bls.gov/ooh/healthcare/optometrists.htm">https://www.bls.gov/ooh/healthcare/optometrists.htm</a> (visited Apr. 27, 2022).
\66\ ECP University, ``Key Metrics: Assessing Optometric
Practice Performance & Best Practices of Spectacle Lens Management
Report,'' 25 (March 22, 2018), <a href="https://ecpu.com/media//wysiwyg/docs/ECPU_MBA_KeyMetricsReport_2018.pdf">https://ecpu.com/media//wysiwyg/docs/ECPU_MBA_KeyMetricsReport_2018.pdf</a> (``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), <a href="https://www.reviewob.com/wp-content/uploads/2016/11/paa_visionsource__0413.pdf">https://www.reviewob.com/wp-content/uploads/2016/11/paa_visionsource__0413.pdf</a> (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., <a href="https://www.reviewob.com/key-practice-metrics-numbers-to-track-grow-to-speed-practice-recovery/">https://www.reviewob.com/key-practice-metrics-numbers-to-track-grow-to-speed-practice-recovery/</a> (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\ <a href="http://OpticianEDU.org">OpticianEDU.org</a>, ``Optician Certification,'' <a href="https://www.opticianedu.org/optician-certification/">https://www.opticianedu.org/optician-certification/</a>.
\69\ Bureau of Labor Statistics, U.S. Dep't of Labor,
Occupational Outlook Handbook, Opticians, <a href="https://www.bls.gov/ooh/healthcare/opticians-dispensing.htm">https://www.bls.gov/ooh/healthcare/opticians-dispensing.htm</a> (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 <a href="https://thevisioncouncil.org/sites/default/files/assets/media/TVC-COVID-19-VisionWatch-Consumer-Industry-Research_Member-Insights-Webinar-5-21-2020_w-Notes.pdf">https://thevisioncouncil.org/sites/default/files/assets/media/TVC-COVID-19-VisionWatch-Consumer-Industry-Research_Member-Insights-Webinar-5-21-2020_w-Notes.pdf</a>.
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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
<a href="http://Regulations.gov">Regulations.gov</a>.
<a href="https://www.regulations.gov/document/FTC-2015-0093-0001">https://www.regulations.gov/document/FTC-2015-0093-0001</a> (CLR RFC
Comments); <a href="https://www.regulations.gov/document/FTC-2016-0098-0001">https://www.regulations.gov/document/FTC-2016-0098-0001</a>
(CLR NPRM Comments); <a href="https://www.regulations.gov/document/FTC-2017-0099-0001">https://www.regulations.gov/document/FTC-2017-0099-0001</a> (CLR WS Comments); and <a href="https://www.regulations.gov/document/FTC-2019-0041-0001">https://www.regulations.gov/document/FTC-2019-0041-0001</a> (CLR SNPRM Comments). <a href="http://Regulations.gov">Regulations.gov</a>
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
<a href="http://Regulations.gov">Regulations.gov</a>.
\100\ 16 CFR 315.3.
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(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\
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\102\ Eyeglass Rule ANPR, 80 FR 53274, 53276.
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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\
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\103\ The comments are posted at <a href="https://www.regulations.gov/document/FTC-2015-0095-0001">https://www.regulations.gov/document/FTC-2015-0095-0001</a>. This document cites comments from the
Eyeglass Rule ANPR using the comment number assigned by
<a href="http://Regulations.gov">Regulations.gov</a> 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
<a href="http://Regulations.gov">Regulations.gov</a> 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 <a href="https://www.visionmonday.com/vm-reports/article/key-optical-players-ranked-by-us-sales-in-2019/">https://www.visionmonday.com/vm-reports/article/key-optical-players-ranked-by-us-sales-in-2019/</a>.
\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).
---------------------------------------------------------------------------
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.
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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
<a href="https://www.pacificu.edu/about/directory/people/karl-citek-ms-od-Ph.D.-faao">https://www.pacificu.edu/about/directory/people/karl-citek-ms-od-Ph.D.-faao</a>.
\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 <a href="https://www.visionmonday.com/latest-news/article/ola-announces-2009-directors-choice-recipient-and-awards-of-excellence-final-nominees-16057/?msclkid=740f9983c64b11ec8e35481006e0819a">https://www.visionmonday.com/latest-news/article/ola-announces-2009-directors-choice-recipient-and-awards-of-excellence-final-nominees-16057/?msclkid=740f9983c64b11ec8e35481006e0819a</a> 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\
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\159\ Barnes (Comment #0043); Lunsford (Comment #0346).
\160\ Barnes (Comment #0043).
\161\ Lunsford (Comment #0346); B.C. (Comment #0749).
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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.
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\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.
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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.
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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\
---------------------------------------------------------------------------
\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\
---------------------------------------------------------------------------
\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), <a href="https://www.ftc.gov/news-events/press-releases/2020/12/ftc-sends-28-warning-letters-regarding-agencys-eyeglass-rule">https://www.ftc.gov/news-events/press-releases/2020/12/ftc-sends-28-warning-letters-regarding-agencys-eyeglass-rule</a>. 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), <a href="https://www.ftc.gov/news-events/press-releases/2016/05/ftc-issues-warning-letters-regarding-agencys-eyeglasses-rule">https://www.ftc.gov/news-events/press-releases/2016/05/ftc-issues-warning-letters-regarding-agencys-eyeglasses-rule</a>.
\173\ Press Release, Fed. Tr. Comm'n, FTC Issues Warning Letters
Regarding the Agency's Contact Lens Rule (Apr. 7, 2016), <a href="https://www.ftc.gov/news-events/press-releases/2016/04/ftc-issues-warning-letters-regarding-agencys-contact-lens-rule">https://www.ftc.gov/news-events/press-releases/2016/04/ftc-issues-warning-letters-regarding-agencys-contact-lens-rule</a>. 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\
---------------------------------------------------------------------------
\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 <a href="https://wwws.law.northwestern.edu/faculty/fulltime/diamond/papers/referenceguidesurveyresearch.pdf">https://wwws.law.northwestern.edu/faculty/fulltime/diamond/papers/referenceguidesurveyresearch.pdf</a>; Fowler, How Unclear Terms Affect
Survey Data, The Public Opinion Quarterly (Summer 1992), available
at <a href="https://www.jstor.org/stable/2749171">https://www.jstor.org/stable/2749171</a>; 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.
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\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)).
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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.
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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.
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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\
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\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), <a href="https://www.ftc.gov/news-events/press-releases/1996/05/dallas-eyecare-center-agrees-settle-charges-they-failed-give">https://www.ftc.gov/news-events/press-releases/1996/05/dallas-eyecare-center-agrees-settle-charges-they-failed-give</a>.
\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 <a href="http://Lens.com">Lens.com</a> (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.
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\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); <a href="http://Lens.com">Lens.com</a> (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.
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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\
---------------------------------------------------------------------------
\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\
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\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.
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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.
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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\
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\234\ 16 CFR 315.3(c).
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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).
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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\
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\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, <a href="https://www.regulations.gov/document/HHS-OCR-2018-0028-0001">https://www.regulations.gov/document/HHS-OCR-2018-0028-0001</a>.
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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.
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\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.
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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.
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\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.
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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\
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\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.
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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\
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\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\
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\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.
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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.
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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.
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\277\ See Sections II.A, IV.A.6, supra.
\278\ 16 CFR 456.2(a).
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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.
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\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),
<a href="https://www.healthit.gov/sites/default/files/Attachment_1_-_2-26-16_RTC_Health_IT_Progress.pdf">https://www.healthit.gov/sites/default/files/Attachment_1_-_2-26-16_RTC_Health_IT_Progress.pdf</a>. 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,'' <a href="https://www.healthit.gov/playbook/pe/introdu
[…truncated; see source link]Indexed from Federal Register on January 3, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.