[Federal Register Volume 81, Number 235 (Wednesday, December 7, 2016)]
[Proposed Rules]
[Pages 88526-88559]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-28471]
[[Page 88525]]
Vol. 81
Wednesday,
No. 235
December 7, 2016
Part V
Federal Trade Commission
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16 CFR Part 315
Contact Lens Rule; Proposed Rule
Federal Register / Vol. 81 , No. 235 / Wednesday, December 7, 2016 /
Proposed Rules
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FEDERAL TRADE COMMISSION
16 CFR Part 315
RIN 3084-AB36
Contact Lens Rule
AGENCY: Federal Trade Commission (``FTC'' or ``Commission'').
ACTION: Notice of proposed rulemaking; request for public comment.
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SUMMARY: As part of its regulatory review of the Contact Lens Rule
(``Rule''), and consistent with the requirements of the Fairness to
Contact Lens Consumers Act (the ``Act''), the Federal Trade Commission
proposes to amend the Rule to require that prescribers obtain a signed
acknowledgment after releasing a contact lens prescription to a
patient, and maintain each such acknowledgment for a period of not less
than three years. The Commission seeks comment on this proposal and
several other issues.
DATES: Written comments must be received on or before January 30, 2017.
ADDRESSES: Interested parties may file a comment online or on paper by
following the instructions in the Request for Comment part of the
SUPPLEMENTARY INFORMATION section below. Write ``Contact Lens Rule, 16
CFR part 315, Project No. R511995'' on your comment, and file your
comment online at https://ftcpublic.commentworks.com/ftc/contactlensrule by following the instructions on the web-based form. If
you prefer to file your comment on paper, write ``Contact Lens Rule, 16
CFR part 315, Project No. R511995'' 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, or deliver your comment to the
following address: Federal Trade Commission, Office of the Secretary,
Constitution Center, 400 7th Street SW., 5th Floor, Suite 5610 (Annex
C), Washington, DC 20024.
FOR FURTHER INFORMATION CONTACT: Elizabeth Delaney, Attorney, (202)
326-2903, or Paul Spelman, Attorney, (202) 326-2487, Division of
Advertising Practices, Bureau of Consumer Protection, Federal Trade
Commission, 600 Pennsylvania Avenue NW., Washington, DC 20580.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Background
A. Overview of the Contact Lens Rule
B. Regulatory History
C. The Evolving Contact Lens Marketplace
II. Contact Lens Rule Review
III. Availability of Contact Lens Prescriptions to Patients
A. Section 315.3(a)(1)--Automatic Prescription Release
1. Compliance With the Automatic Prescription Release
Requirement
2. Commenter Suggestions for Improving Automatic Prescription
Release Compliance
3. Analysis of Proposals for Improving Automatic Prescription
Release Compliance and Commission Proposal
(a) Proposal To Increase Enforcement
(b) Proposal To Require an Eye Care Patients' Bill of Rights or
Notice-Upon-Check-In
(c) Proposal To Require a Signed Acknowledgment Form
(d) Proposal To Require Signage
(e) The Commission's Proposal To Require a Signed Acknowledgment
4. Additional Mechanisms for Improving Prescription Portability
B. Section 315.3(a)(1)--Additional Copies of Prescriptions
C. Section 315.3(a)(2)--Provide or Verify the Contact Lens
Prescription
1. Sellers Designated To Act on Behalf of Patients
IV. Prescriber Verification
A. Section 315.5(a)--Prescription Requirement
1. Presentation of Prescriptions ``Directly or By Facsimile''
2. ``Verified by Direct Communication''
3. Automated Telephone Calls as a Method of Direct Communication
B. Section 315.5(b)--Information for Verification
1. Vendor Contact Information
2. Prescribers' Selection of Communication Mechanism
C. Section 315.5(c)--Verification Events
1. Passive Verification
2. Issues Regarding the Eight-Business-Hour-Window
V. Contact Lens Prescriptions
A. Section 315.6--Expiration of Contact Lens Prescriptions
1. Length of Contact Lens Prescriptions
2. Expired Contact Lens Prescriptions
3. Quantities of Contact Lenses Obtained by Patients
B. Private Label Lenses and Contact Lens Substitution
1. Private Label Lenses
2. Alteration of Contact Lens Prescriptions by Sellers
C. HIPAA Issues
D. Enforcement Efforts
E. Recommendations Regarding the Commission's Complaint
Reporting System
VI. Request for Comment
VII. Communications by Outside Parties to the Commissioners or Their
Advisors
VIII. Paperwork Reduction Act
A. Estimated Additional Hours Burden
B. Estimated Total Labor Cost Burden
IX. Regulatory Flexibility Act
A. Description of the Reasons the Agency Is Taking Action
B. Statement of the Objectives of, and Legal Basis for, the
Proposed Amendments
C. Small Entities to Which the Proposed Amendments Will Apply
D. Projected Reporting, Recordkeeping, and Other Compliance
Requirements, Including Classes of Covered Small Entities and
Professional Skills Needed To Comply
X. Proposed Rule Language
I. Background
A. Overview of the Contact Lens Rule
In 2003, Congress enacted the Fairness to Contact Lens Consumers
Act,\1\ and pursuant to the Act, the Commission promulgated the Contact
Lens Rule on July 2, 2004.\2\ The Rule went into effect on August 2,
2004.
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\1\ 15 U.S.C. 7601-7610 (Pub. L. 108-164).
\2\ Contact Lens Rule, 16 CFR 315 (2015).
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The Contact Lens Rule promotes competition in retail sales of
contact lenses by facilitating consumers' ability to comparison shop
for contact lenses. When a prescriber completes a contact lens fitting,
the Rule requires that the prescriber provide the patient with a
portable copy of her prescription. The Rule also requires that the
prescriber verify or provide such prescriptions to authorized third
parties. At the same time, the Rule requires that contact lens vendors
only sell contact lenses in accordance with valid prescriptions written
by licensed prescribers.
The Rule specifies that a prescriber may not require: (1) The
purchase of contact lenses as a condition of providing the prescription
or verification; (2) payment in addition to, or as a part of, the fee
for an eye examination, fitting, and evaluation as a condition of
providing the prescription or verification; or (3) the patient to sign
a waiver or release as a condition of releasing or verifying the
prescription.\3\ The prescriber is also prohibited from requiring
immediate payment before the release of a prescription, unless the
prescriber requires immediate payment when an exam reveals that the
consumer does not need ophthalmic goods.\4\
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\3\ 16 CFR 315.3(b).
\4\ 16 CFR 315.4.
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The Rule also places certain requirements on sellers. It mandates
that sellers dispense contact lenses only in accordance with a valid
prescription that is either presented to the seller or verified by
direct communication with the prescriber.\5\ The Rule sets out the
information that must be included in a seller's verification request,
and directs that a prescription is only verified under the Rule if: (1)
A prescriber confirms the prescription is accurate; (2) a prescriber
informs the seller that the prescription is inaccurate and provides an
accurate
[[Page 88527]]
prescription in its stead; or (3) the prescriber fails to communicate
with the seller within eight business hours after receiving a compliant
verification request.\6\ The Rule states that if the prescriber informs
the seller within eight hours of receiving the verification request
that the prescription is inaccurate, expired, or invalid, the seller
shall not fill the prescription. The Rule requires that the prescriber
specify the basis for the inaccuracy or invalidity of the prescription,
and if the prescription is inaccurate, the prescriber must correct
it.\7\
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\5\ 16 CFR 315.5(a).
\6\ 16 CFR 315.5(b)-(c).
\7\ 16 CFR 315.5(d).
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Sellers may not alter a prescription, but for private label contact
lenses, may substitute identical contact lenses that the same company
manufactures and sells under a different name.\8\ Sellers and others
involved in the manufacture, assembly, processing, and distribution of
contact lenses are prohibited from representing that contact lenses may
be obtained without a prescription.\9\
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\8\ 16 CFR 315.5(e).
\9\ 16 CFR 315.7.
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The Contact Lens Rule sets a minimum expiration date of one year
after the issue date of a prescription with an exception based on a
patient's ocular health.\10\ The Rule also incorporates the Act's
preemption of state and local laws and regulations that establish a
prescription expiration date of less than one year or that restrict
prescription release or require active verification.\11\
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\10\ 16 CFR 315.6.
\11\ 16 CFR 315.11(a). The Rule states further that ``[a]ny
other state or local laws or regulations that are inconsistent with
the Act or this part are preempted to the extent of the
inconsistency.'' 16 CFR 315.11(b).
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B. Regulatory History
The FTC has more than three decades of regulatory and research
experience regarding the optical goods industry. In addition to the
Contact Lens Rule, the Commission enforces the Ophthalmic Practice
Rules (hereinafter ``Eyeglass Rule''), initially promulgated in
1978.\12\ Prior to the Eyeglass Rule, many prescribers either refused
to release prescriptions to their patients or charged an additional fee
to do so.\13\ Prices for glasses varied widely, but without their
prescriptions, or without paying a fee to obtain their prescriptions,
consumers could not comparison shop among prescribers and other vendors
and purchase from sellers that best met their needs for price, service,
and convenience.\14\ Moreover, competition did not lead the industry to
offer what consumers could not choose: when consumers' ability to
comparison shop is diminished, the normal competitive pressures on the
eye care industry to offer competitive prices--or the combination of
prices, features, and services most in demand--are themselves
diminished. To address this problem, the Eyeglass Rule requires
prescribers--generally, optometrists and ophthalmologists--to provide
each of their patients, immediately after completion of an eye
examination, a free copy of the patient's eyeglass prescription.\15\
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\12\ Advertising of Ophthalmic Goods and Services, 43 FR 23992
(June 2, 1978). The Rule was revised in 1992, with the revisions
codified at 16 CFR 456. Ophthalmic Practice Rules, 57 FR 18822 (May
1, 1992).
\13\ 43 FR at 23998. The Commission found, for example, that in
nearly every survey of practicing optometrists considered in the
rulemaking record, more than 50% of optometrists imposed a
restriction on the availability of eyeglass prescriptions to
patients. See id.
\14\ Fed. Tr. Comm'n, ``The Strength of Competition in the Sale
of Rx Contact Lenses: An FTC Study,'' 45-46 (2005), http://www.ftc.gov/reports/contactlens/050214contactlensrpt.pdf
[hereinafter 2005 Contact Lens Report].
\15\ 16 CFR 456.2 (separation of examination and dispensing).
The FTC also has studied the effects of state-imposed restrictions
in the optical goods industry. See Fed. Tr. Comm'n, Bureau of
Economics Staff Paper, ``The Effects of Restrictions on Advertising
and Commercial Practice in the Professions: The Case of Optometry''
(1980), https://www.ftc.gov/sites/default/files/documents/reports/effects-restrictions-advertising-and-commercial-practice-professions-case-optometry/198009optometry.pdf.
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Consumers, sellers, and state officials complained that contact
lens consumers faced similar hurdles when trying to comparison shop for
contact lenses.\16\ To achieve freedom of choice and the benefits of
competition for contact lens consumers, in 2003, Congress passed the
Fairness to Contact Lens Consumers Act,\17\ and as the Act required, in
2004, the Commission issued the Contact Lens Rule,\18\ implementing the
Act.
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\16\ For example, in In re Disposable Contact Lens Antitrust
Litigation, the Attorneys General of 31 states and a certified class
alleged that eye care professionals engaged in an organized effort
to prevent or hinder consumers from obtaining their contact lens
prescriptions. In re Disposable Contact Lens Antitrust Litigation,
No. 94-MDL 1030-J-20A (M.D. Fla.). The complaints alleged two
conspiracies: (1) that the practitioners and their trade
associations conspired to prevent the release of contact lens
prescriptions to consumers, and (2) that manufacturers,
practitioners, and trade associations, including the American
Optometric Association, conspired to eliminate sales of contact
lenses by pharmacies, mail order, and other alternative sellers. Id.
According to the complaints, the conspiracy severely restricted the
supply of contact lenses available to alternative sellers, which
hampered the growth of such sellers, decreased the supply of lenses
to consumers, and increased the price of lenses. Id. The parties
reached settlements, the last of which the court approved in
November 2001. As part of the settlements, defendant manufacturers
agreed to sell contact lenses to alternative distribution channels.
\17\ 15 U.S.C. 7601-7610 (Pub. L. 108-164).
\18\ Contact Lens Rule, 69 FR 40482 (July 2, 2004) (codified at
16 CFR 315). Pursuant to its congressional mandate, the FTC also
issued a study of competition in the contact lens industry in 2005.
See 2005 Contact Lens Report, supra note 14.
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As specified in the Act, the Rule imposes requirements on both
sellers and prescribers of contact lenses. Because the use of contact
lenses involves significant health issues,\19\ the Act requires that
contact lenses be sold only to patients with valid prescriptions, which
they receive after contact lens fittings. As noted above, the Act and
the Contact Lens Rule only allow sales of contact lenses when the
seller has a copy of the patient's prescription or has verified that
prescription with the prescriber.\20\ Sellers also are prohibited from
altering a contact lens prescription.\21\ The U.S. Food and Drug
Administration (``FDA'') has strict labeling requirements for contact
lenses, and it has the authority to take action against the sales of
such lenses, which are medical devices, without a valid
prescription.\22\
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\19\ See, e.g., Fed. Tr. Comm'n, ``Possible Barriers to E-
Commerce: Contact Lenses, A Report from the Staff of the Federal
Trade Commission,'' 8-9 (Mar. 2004), http://www.ftc.gov/os/2004/03/040329clreportfinal.pdf [hereinafter 2004 Possible Barriers to E-
Commerce Report].
\20\ 16 CFR 315.5(a).
\21\ 16 CFR 315.5(e).
\22\ See 21 U.S.C. 331(a), 333, 352(f), and 353(b)(1).
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Because of concerns that many prescribers had impeded consumers'
ability to comparison shop for contact lenses--even following
appropriate diagnosis and fitting by the prescribers--the Act and the
Rule also impose obligations on the prescribers themselves. As noted
above, prescribers are required to release a copy of the prescription
to the consumer, promptly upon completion of the contact lens fitting,
``[w]hether or not requested by the patient.'' \23\ That copy must be
complete and portable to enable comparison shopping: it must contain
``sufficient information for the complete and accurate filling of a
prescription.'' \24\ Prescribers also are prohibited from requiring the
purchase of contact lenses as a condition of either prescription
release or verification, from requiring a separate payment for
prescription release or verification, and from requiring that the
patient sign a waiver as a condition of prescription release or
verification.\25\
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\23\ 15 U.S.C. 7601(a)(1); 16 CFR 315.3(a)(1).
\24\ 15 U.S.C. 7610(3); 16 CFR 315.2.
\25\ 15 U.S.C. 7601(b)(1)-(3); 16 CFR 315.3(b)(1)-(3).
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Prescribers also are required to provide or verify a contact lens
[[Page 88528]]
prescription when ``directed by any person designated to act on behalf
of the patient.'' \26\ Sales of contact lenses require a valid
prescription that is verified by a prescriber. Such verification takes
place: (1) When the prescriber confirms that the prescription is
accurate, by phone, facsimile, or electronic mail; (2) when the
prescriber informs the seller that the prescription is inaccurate and
provides the correct prescription; or (3) when the seller seeks
verification of a given prescription from a prescriber, and the
prescriber does not communicate with the seller within eight business
hours of the seller's request for information.\27\ This eight-hour,
default ``passive verification'' lessens the demands on prescribers in
the event a seller forwards a query about an accurate and complete
prescription from a properly identified patient. It also prevents
prescribers from blocking verification--and impeding consumer access to
contact lenses--simply by refusing to respond to verification requests.
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\26\ 15 U.S.C. 7601(a)(2) (must, as directed by authorized
party, ``provide or verify'' the prescription); 16 CFR 315.3(a)(2).
\27\ 15 U.S.C. 7603(d)(1)-(3); 16 CFR 315.5.
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C. The Evolving Contact Lens Marketplace
When contact lenses were first introduced, they were made of rigid
material that required a prescriber to custom fit each pair. Beginning
in the late 1980s, manufacturers began to sell disposable lenses,
designed to be replaced on a daily, weekly, or monthly basis. In
addition, technological advances resolved most lens-standardization
issues, eliminating the need for a prescriber to fit each pair to the
individual once the initial prescription had been finalized. Today, the
vast majority of replacement lenses bought pursuant to an individual's
prescription will be identical, regardless of whether the patient
purchases them from the prescriber or a third-party seller.\28\ This
enables the sale of lenses to be unbundled from the fitting exam, and
makes it feasible for non-prescribers to sell contact lenses.
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\28\ However, contact lens prescriptions are brand specific, and
as a general matter, one brand cannot be substituted for another,
even if the other technical parameters (power, base curve, diameter,
cylinder, and axis) are identical. As noted previously, sellers may
substitute identical contact lenses that the same company
manufactures and sells under a different name.
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These technological advances have increased the comfort and
convenience of contact lenses, leading to growth in the number of
contact lens wearers, and changes in the type and variety of lenses
worn. According to the U.S. Centers for Disease Control and Prevention
(``CDC''), there are now approximately 40.9 million contact lens
wearers in the United States age 18 and older, representing more than
16% of the population.\29\
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\29\ Jennifer R. Cope et al., ``Contact Lens Wearer Demographics
and Risk Behaviors for Contact Lens-Related Eye Infections--United
States, 2014,'' Morb. Mortal. Wkly. Rep. 64(32):865-70, 866 (Aug.
21, 2015). See also Vision Council, ``Consumer Barometer,'' Sept.
2015 (estimating that 16.2% of American adults wear contact lenses).
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Overall, the U.S. market for contact lenses currently is estimated
to be between $4 billion and $5 billion annually.\30\ Of that,
approximately 40% of sales are made by independent eye care
professionals (optometrists and ophthalmologists), 19% by conventional
retail chains (such as LensCrafters, etc.), 25% from mass merchants and
wholesale clubs (such as Costco, Sam's Club, etc.), and 18% by online
sellers (16% of sales are by ``pure play'' online sellers, such as 1-
800 CONTACTS, that do not have a physical retail presence).\31\ By
contrast, in 2006, the total U.S. market for contact lenses was
approximately $3.3 billion, with estimated online sales representing
less than 13% of the market.\32\
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\30\ See Vision Council, ``Consumer Barometer,'' Mar. 2014
(valuing the U.S. contact lens market at $4.2 billion); Vision
Council, ``Consumer Barometer,'' Sept. 2015 (valuing the U.S.
contact lens market at $4.6 billion).
\31\ Vision Council, ``U.S. Optical Industry Report Card,'' Dec.
2015.
\32\ See Vision Council, supra note 30.
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There also are significantly more types of lenses in the U.S. now
than there were 10 to 15 years ago.\33\ At the same time, use of daily
disposable lenses increased from just 7.5% in 2005 to 28% in 2015,
while use of conventional one-year lenses declined sharply, from 19% to
1%.\34\
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\33\ These include, among others, soft spherical (common soft
lenses), soft toric (lenses for astigmatic patients), soft
multifocal (lenses for presbyotic patients), spherical corneal GP
(rigid lenses for presbyotic and astigmatic patients), and scleral
(lenses for patients with corneal irregularities). Furthermore,
according to Johnson & Johnson Vision Care, Inc., more than 160
different brands of contact lenses are available. Comment #582. See
also Jason J. Nichols, ``2015 Annual Report,'' Contact Lens
Spectrum, Jan. 1, 2016, http://www.clspectrum.com/articleviewer.aspx?articleID=113689.
\34\ Carla J. Mack, ``Annual Report, Contact Lenses 2007,''
Contact Lens Spectrum, Jan. 1, 2008, http://www.clspectrum.com/articleviewer.aspx?articleID=101240; Nichols, supra note 33.
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II. Contact Lens Rule Review
On September 3, 2015, the Commission solicited comments on the
Contact Lens Rule as part of its periodic review of its rules and
guides.\35\ The Commission sought comments on: The economic impact of,
and the continuing need for, the Rule; the benefits of the Rule to
consumers purchasing contact lenses; the burdens the Rule places on
entities subject to its requirements; the impact the Rule has had on
the flow of information to consumers; the degree of industry compliance
with the Rule; the need for any modifications to increase its benefits
or reduce its burdens or to account for changes in relevant technology;
and any overlap or conflict with the Rule and other federal, state, or
local laws or regulations. The comment period closed on October 26,
2015.
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\35\ Contact Lens Rule, Request for Comment, 80 FR 53272 (Sept.
3, 2015).
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This Notice of Proposed Rulemaking (``NPRM'') summarizes the
comments received and explains the Commission's decision to retain the
Contact Lens Rule. It also explains why the Commission proposes certain
amendments and why it declines to propose others. Additionally, it
seeks 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 660 comments from individuals and entities
representing a wide range of viewpoints, including prescribing eye care
practitioners (ophthalmologists and optometrists), opticians and other
eye-wear industry members, sellers of contact lenses (both online and
brick-and-mortar), contact lens manufacturers, and consumer and
competition advocates.\36\ Virtually all commenters agreed that there
is a continuing need for the Rule and that it benefits consumers and
competition. The majority of commenters recommended some modifications
to the Rule in order to maximize the benefits to consumers and
competition, decrease the burden on businesses, protect consumers' eye
health, or improve overall compliance with the Rule's existing
requirements. Many commenters--including prescribers, sellers,
manufacturers, legislators, and consumer advocates--also indicated that
increased enforcement efforts would be beneficial.
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\36\ The comments are posted at: https://www.ftc.gov/policy/public-comments/initiative-621. The Commission has assigned each
comment a number appearing after the name of the commenter and the
date of submission. This notice cites comments using the last name
of the individual submitter or the name of the organization,
followed by the number assigned by the Commission.
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Some commenters--including contact lens sellers, opticians, state
and federal legislators, consumer advocacy groups, and others--stated
that the Act's intent to provide a competitive marketplace is
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not being fully realized because prescribers are not complying with one
of the major underpinnings of the Rule: the automatic release of
prescriptions to patients.\37\ Some commenters also asserted that some
prescribers are interfering with the prescription verification process
and thereby impeding consumers' ability to comparison shop.\38\
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\37\ See, e.g., Utah Retail Merchants Association (Comment #28);
Information Technology & Innovation Foundation (Comment #40); Rhode
Island State Representative Kennedy (Comment #536); Arizona State
Representative Carter (Comment #545); Utah State Senator Bramble
(Comment #576); Lens.com (Comment #614); Consumers Union (Comment
#677).
\38\ See, e.g., LD Vision Group (Comment #544); National
Association of Optometrists and Opticians (Comment #549); 1-800
CONTACTS (Comment #568); Warby Parker (Comment #593).
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Many commenters discussed the fact that the use of contact lenses
presents certain eye health risks. Prescribers pointed out that merely
by wearing contact lenses, patients will experience an increased risk
for microbial keratitis (also referred to as infectious or bacterial
keratitis).\39\ Indeed, contact lens wear has been identified as the
largest single risk factor for microbial keratitis.\40\ Furthermore,
this risk increases if a patient wears the lenses too long, wears the
lenses overnight, or fails to comply with the recommended replacement
schedule.\41\ Other commenters noted that additional risk factors for
ocular complications include improper care of the lenses or poor
hygiene practices.\42\ Other commenters pointed out that improperly
fitting contact lenses may result in corneal ulcers and other health
issues.\43\
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\39\ See, e.g., Whipple (Comment #15); Nelson (Comment #130).
See also CLAO (Comment #572) (commenting that ``[t]he CDC points out
that the largest single risk factor for microbial keratitis is
contact lens wear''); Lupinski (Comment #499) (``[s]tudies over the
years have shown that wearing contact lenses increases the risk for
ocular health complications'').
\40\ Cope, supra note 29, at 866.
\41\ See id. at 867 (``sleeping in any type of contact lens
increases risk for eye infection''); Fiona Stapleton, et al., ``The
Incidence of Contact Lens-Related Microbial Keratitis in
Australia,'' Ophthalmology 2008; 115:1655, 1659 (``Overnight use of
[contact lenses], irrespective of material type, continues to be the
main risk factor for corneal infection.''). See also Whipple
(Comment #15); Buthod (Comment #81); Morgan (Comment #144); Lupinski
(Comment #499); Bearden (Comment #554).
\42\ See, e.g., Shlosman (Comment #290); Israel (Comment #429);
Bearden (Comment #554); Barnett (Comment #668). See also CLAO
(Comment #572) (citing to a recent CDC report that found outbreaks
of serious eye infections among contact lens wearers continue and
``are associated with failure to wear, clean, disinfect and store
their lenses as directed'').
\43\ See, e.g., Raykovicz (Comment #35); Morgan (Comment #144);
Pusz (Comment #646); see also American Academy of Ophthalmology
(Comment #611) (``[w]earing improper lenses can further complicate
existing vision issues, including leading to infection in the
eye'').
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In light of the risks associated with the use of contact lenses,
many commenters--including individual prescribers, optometric and
ophthalmologic associations, and contact lens manufacturers--stressed
the important need to adequately protect eye health and safety and
argued that the current Rule framework is not sufficient to do so.\44\
For example, the Contact Lens Association of Ophthalmologists, Inc.
(``CLAO'') asserted that the Rule's passive verification framework
``creates a mechanism for renewal of expired prescriptions'' and
``eliminates a critical opportunity to improve the public health of
contact lens consumers by addressing risky wear and care practices.''
\45\ As support, the CLAO comment cited to an article in the CDC's
weekly report recommending vigorous health promotion activities to
encourage contact lens wearers to improve their hygiene behaviors.\46\
However, the comment did not include any empirical evidence showing
that the passive verification mechanism has actually resulted in the
renewal of expired prescriptions. Furthermore, the CLAO did not present
any data showing that patients are not visiting their eye care
practitioners as a result of the passive verification mechanism (or any
other Rule provision).
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\44\ Commenters provided illustrations of how they believe the
current operation of the Rule is jeopardizing consumer health. For
example, some commenters posited that loopholes in the Rule allow
patients to obtain lenses with expired, or otherwise invalid,
prescriptions. According to this line of argument, patients are
obtaining lenses without annual eye examinations, or without the
proper medical oversight to monitor their use of contact lenses, and
this could result in delayed or missed diagnosis of contact lens-
related eye issues, other eye health issues, or other health
conditions that otherwise would be detected during an annual eye
examination. Commenters also expressed concerns that if patients do
not visit eye care prescribers regularly, they will not receive
proper training on the care and use of contact lenses.
\45\ Comment #572. See also American Optometric Association
(Comment #644) (``[a]llowing repurchases based on long-expired
prescriptions may be, at the time, convenient for the patient and
profitable for the seller, but increases the risk of patient
harm'').
\46\ Cope, supra note 29.
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Other examples of patient harm identified by commenters were either
hypothetical or anecdotal (such as case reports about the experiences
of individual patients).\47\ The comments did not include data
indicating the number or percentage of patients who obtain lenses
without a valid prescription, or empirical evidence that patients are
seeing their eye care practitioners less frequently than they did prior
to the Rule's adoption. In addition, while some commenters stated that
patients are obtaining lenses without proper medical supervision,
industry data indicates that approximately 40% of contact lenses are
still obtained directly from independent prescribers, and only roughly
16% of contact lenses are obtained from online-only sellers, the retail
venue most frequently mentioned by commenters.\48\ Most importantly,
these commenters did not point to any evidence that the implementation
of the Rule has increased the incidence of contact lens complications.
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\47\ See, e.g., Combs (Comment #90) (patient with corneal ulcer
had not been to doctor in eight years); Simmons (Comment #104)
(patient ordered contacts using spectacle prescription with on
online retailer; never given proper hygiene training); Mansito
(Comment #122) (sister ordered lenses online with expired
prescription; they did not fit and she needed corneal transplant);
Ahn (Comment #215) (patient sleeping in lenses for a week at a time,
using outdated prescription).
\48\ Vision Council, ``U.S. Optical Industry Report Card,'' Dec.
2015.
---------------------------------------------------------------------------
Other commenters argued that contact lens sales through alternative
supply channels put patients at higher risk for ocular complications.
The American Academy of Optometry, for example, asserted that ``careful
peer reviewed research over the past ten years'' shows that ``the
development of alternative supply chains for the sale of contact
lenses--and the use of those alternative supply chains by contact lens
patients--has itself become an identifiable risk factor for ocular
morbidity in contact lens patients.'' \49\ To support this contention,
this commenter cited several studies that it believes show that
internet purchasers of contact lenses are more likely to engage in
harmful eye care practices,\50\ to have a significant difference in
aftercare awareness,\51\ and to have a higher risk of developing
microbial keratitis.\52\ The Commission examined each of these studies
and concludes that they are not sufficient to reliably demonstrate that
purchasing lenses online is a risk factor, or that online purchasers
are at a higher risk of developing microbial keratitis or any other
ocular complication.\53\
---------------------------------------------------------------------------
\49\ Comment #623.
\50\ Joshua Fogel & Chaya Zidile, ``Contact lenses purchased
over the Internet place individuals potentially at risk for harmful
eye care practices,'' Optometry, 79.1 (2008) 23-35.
\51\ Yvonne Wu et al., ``Contact lens user profile, attitudes
and level of compliance to lens care,'' Cont. Lens Anterior Eye 33
(2010) 183-188.
\52\ Stapleton, supra note 41.
\53\ The Fogel and Wu studies have relatively small samples of
consumers who purchased contact lenses over the Internet and the
sample recruiting methodologies call into question whether the
results are generalizable to the national population. In addition,
the results of these studies link purchase locations to consumer
behaviors such as having a doctor check the contact lens fitting
after purchase or awareness of recommended follow-up visit, rather
than actual adverse eye health outcomes. The Stapleton study
identified Internet/mail order purchases as a potential risk factor
for microbial keratitis in a large sample from Australia. However,
when the authors of the Stapleton study limit their sample to cases
of moderate to severe keratitis, Internet/mail order purchases are
not found to be a risk factor. See Fiona Stapleton et al., ``Risk
factors for moderate and severe microbial keratitis in daily wear
contact lens users,'' Ophthalmology 2012; 119:1516-1521.
---------------------------------------------------------------------------
[[Page 88530]]
Some commenters merely asserted that patient eye health is being
compromised because online retailers do not comply with the Rule,\54\
online retailer practices have convinced consumers that contact lenses
are a commodity rather than a medical device,\55\ and online retailers
do not provide patients with proper care instructions.\56\ Other
prescribers alleged that patients who purchase contact lenses online or
through mail order companies are noncompliant with follow-up eye care
and the safe use of contact lenses,\57\ or purchase lenses with expired
prescriptions and then experience complications.\58\ A few commenters
asserted that online purchasing in particular allows patients to obtain
lenses without a valid, unexpired prescription and provided anecdotal
examples of patients who avoided regular eye examinations by purchasing
lenses online.\59\
---------------------------------------------------------------------------
\54\ See, e.g., Weissman (Comment #50); Copeland (Comment #73);
Anderson (Comment #96); Woodland (Comment #98); Wheeden (Comment
#214); Holliday (Comment #249); Arthur (Comment #371); Blankenship
(Comment #395).
\55\ Sancho (Comment #226).
\56\ Miyabe (Comment #481).
\57\ See, e.g., Alford (Comment #18) (stating that they have a
much higher rate of adverse effects such as vision threatening eye
infections and inflammatory conditions, as they usually over wear
their lenses and avoid seeking eye care when they have a
complication).
\58\ See, e.g., Owen (Comment #72); Stephens (Comment #210); Ahn
(Comment #215); Born (Comment #570); King (Comment #655).
\59\ Gronquist (Comment #75); Buthod (Comment #81); Morgan
(Comment #144); Sadeghian (Comment #242).
---------------------------------------------------------------------------
The Commission does not find the evidence proffered in this Rule
review sufficient to support a conclusion that the Rule inadequately
protects consumer eye health. Commenters did not provide sufficient
reliable empirical evidence that the current Rule leads to the
increased acquisition of contact lenses without a valid prescription or
increased incidence of contact lens-related eye disease or adverse eye
conditions. Furthermore, despite commenters' concerns about online or
mail order sales of contact lenses, the Commission has not seen
reliable empirical evidence to support a finding that such sales are
contributing to an increased incidence, or increased risk, of contact
lens-related eye problems.\60\ In addition, the particular risks
associated with contact lens use (or overuse) were previously
considered by Congress and the Commission during the passage of the Act
and the implementation of the Rule.\61\ The current rulemaking record
does not provide any basis to disrupt this original analysis.
---------------------------------------------------------------------------
\60\ Several commenters referenced the article published in the
CDC weekly report (Cope, supra note 29) for the proposition that the
sale of contact lenses requires stricter oversight because of this
article's finding that, ``[a]pproximately 99% of wearers reported at
least one contact lens hygiene risk behavior.'' The Commission notes
two important caveats. First, the authors reached this number by
including any wearer that indicated that they had ``ever'' engaged
in a risk behavior. Hence, the 99% figure includes every wearer, who
at any time, had engaged in a risk behavior even once. Second, the
survey instrument asked users where they purchased their lenses, and
in a separate article, the authors did not conclude that there was
any difference in either habits or health risks based on whether the
lenses were purchased from a provider, retail store without an exam,
or over the internet. See Robin Chalmers et al., ``Is Purchasing
Lenses from the Prescriber Associated with Better Habits Among Soft
Contact Lens Wearers?,'' Cont. Lens Anterior Eye 2016 Aug 12 (Epub
ahead of print) PMID: 27527924.
\61\ See, e.g., 2004 Possible Barriers to E-Commerce Report,
supra note 19, at 8-12.
---------------------------------------------------------------------------
III. Availability of Contact Lens Prescriptions to Patients
Section 315.3 of the Rule provides the framework under which
prescribers are required to release contact lens prescriptions to
patients and other authorized third parties. Section 315.3 also imposes
limitations on the conditions prescribers may require of patients
before releasing their prescription.
A. Section 315.3(a)(1)--Automatic Prescription Release
Section 315.3(a)(1) of the Rule requires a prescriber to provide a
copy of the contact lens prescription to the patient after completing a
contact lens fitting, regardless of whether it was requested by the
patient. Section 315.3(a)(1) of the Rule tracks the language of the Act
verbatim.\62\
---------------------------------------------------------------------------
\62\ 15 U.S.C. 7601(a)(1).
---------------------------------------------------------------------------
This provision, referred to as automatic prescription release, was
intended to empower consumers to comparison shop for contact
lenses.\63\ Automatic prescription release has been in effect for 12
years and is now widely supported by commenters, including both
prescribers \64\ and third-party sellers,\65\ with several recognizing
it as the ``cornerstone,'' \66\ or ``pillar,'' \67\ of the Act and the
Rule. Of the 660 comments received by the Commission, none explicitly
opposed the automatic release provision of the Rule although some
prescribers asserted that from a safety perspective, it is in patients'
best interests to purchase contact lenses from their prescribers rather
than from third-party sellers.\68\ More common, however, were comments
supporting automatic prescription release, but suggesting that the
provision was not sufficiently complied with or enforced.\69\ Other
commenters suggested that the automatic prescription release provision
should take into account advances in technology.
---------------------------------------------------------------------------
\63\ Contact Lens Rule, Notice of Proposed Rulemaking, 69 FR
5440 (Feb. 4, 2004).
\64\ See, e.g., American Academy of Ophthalmology (Comment #611)
(``we believe [the Rule] empowers consumers to comparison shop for
contact lenses''); Coalition for Patient Vision Care Safety (Comment
#621) (``Since enactment, and the FTC's subsequent implementation,
the market for contact lenses has become extremely competitive . . .
This competition has led to increased investment in research and
development, and a proliferation of innovation that served to
benefit the nearly 44 million Americans who use contact lenses every
day.''). See also Carroll (Comment #5); Voight (Comment #551);
Alianello (Comment #253).
\65\ See, e.g., 1-800 CONTACTS (Comment #568); Lens.com (Comment
#614).
\66\ Warby Parker (Comment #593).
\67\ Rhode Island State Representative Kennedy (Comment #536);
1-800 CONTACTS (Comment #568); see also Utah State Senator Bramble
(Comment #576); National Association of Optometrists and Opticians
(Comment #549); Utah Retail Merchants Association (Comment #28).
\68\ See, e.g., Woo (Comment #56).
\69\ See, e.g., 1-800 CONTACTS (Comment #568); Lens.com (Comment
#614); Utah State Senator Bramble (Comment #576).
---------------------------------------------------------------------------
1. Compliance With the Automatic Prescription Release Requirement
Several commenters stated that prescribers routinely fail to comply
with the automatic prescription release requirement: Some do not--or do
not always--provide a prescription unless a consumer explicitly
requests it; some do not provide complete prescriptions, as required by
the Rule; and some do not provide prescriptions at all.\70\ These
comments are, in general, concordant with complaints the Commission has
received from numerous consumers apart from this rule review
process.\71\ Some consumer complaints, however, may be based on a
misunderstanding of the Rule, as there can be confusion
[[Page 88531]]
about when or under what conditions patients should receive their
prescriptions. For example, the Rule requires that a prescription be
provided after the completion of the contact lens fitting, not
necessarily at the conclusion of the initial visit with the prescriber.
Because a fitting may not be complete until a follow-up visit, a
patient might incorrectly believe that she should have been provided
with her prescription at the conclusion of the first visit.
---------------------------------------------------------------------------
\70\ See, e.g., Consumers Union (Comment #677); Rhode Island
State Representative Kennedy (Comment #536); Lens.com (Comment
#614).
\71\ They are also consistent with longstanding practices of eye
care professionals prior to enactment of the Fairness to Contact
Lens Consumers Act, even in states where prescribers were required,
by state statute, to release prescriptions to consumers. See
``Fairness to Contact Lens Consumers Act: Hearing Before the
Subcommittee on Commerce, Trade, and Consumer Protection of the
House Committee on Energy and Commerce,'' 108th Cong. 1 (Sept. 12,
2003) (Testimony of Ami Gadhia, Consumers Union).
---------------------------------------------------------------------------
A number of prescribers commented, to the contrary, that they
always provide contact lens prescriptions to their patients, and
believe that others in their profession do so as well.\72\ Prescribers,
for their part, may be aware in a general way of their obligation to
release prescriptions and yet be unaware of all of the conditions of
prescription release required by the Rule. Hence, they might be
mistaken in assessing, and reporting on, their own compliance.
---------------------------------------------------------------------------
\72\ Howe (Comment #53). See also, e.g., Galdamez (Comment
#167); Ahn (Comment #215).
---------------------------------------------------------------------------
Many reports of compliance and noncompliance are anecdotal, and
robust empirical data are sparse. Although the Commission would prefer
better empirical evidence about compliance and noncompliance with the
Rule, and about the effects of the Rule, some survey evidence has been
submitted by sellers, prescribers, and manufacturers. The Commission
considers these submissions to be suggestive and, to an extent,
informative, but none can be regarded as definitive. It is important to
note, at the outset, that all of these surveys are subject to
particular methodological limitations, as well as limits commonly
associated with survey evidence. For example, patients may sometimes
misremember the details of any particular prior encounter with a
prescriber; prescribers, for their part, may be mistaken about the
particulars of a given clinical encounter, about the frequency with
which they do or do not release prescriptions, or about the frequency
or severity of problems they may encounter in verifying prescriptions.
For the most part, the surveys do not include independent, objective
tests of patient or prescriber recollections. In addition, survey
responses may be sensitive to the ways in which survey questions are
framed.
As part of its comment, 1-800 CONTACTS, the country's largest
online seller of contact lenses, submitted a survey conducted on its
behalf by a third-party research firm, Survey Sampling International.
That survey found that only 35% of contact lens wearers reported
receiving a copy of their prescription without having to ask for
it.\73\ Another 28% reported receiving their prescription upon request
(either at the office or afterwards), while 36% said they never
received it at all.\74\ Additional, and similarly-designed surveys,
conducted on behalf of 1-800 CONTACTS in November 2014 and May 2015
found that 45% and 48% of contact lens wearers, respectively, reported
that they were automatically given a hard copy of their prescription at
their last eye exam.\75\
---------------------------------------------------------------------------
\73\ 1-800 CONTACTS (Comment #568), Exhibit B. According to 1-
800 CONTACTS, the data derives from an online survey of 500 contact
lens wearers ages 18-49 years old by Survey Sampling International
between Oct. 1 and Oct. 6, 2015. The respondents were not informed
of the identity of the survey sponsor. The Commission has concerns
about the methodology utilized for this survey, particularly about
the lack of an ``I don't know'' option for various 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.
\74\ Id. at 3.
\75\ 1-800 CONTACTS (Comment #568), Exhibit C. According to 1-
800 CONTACTS, these data are based on two surveys of 2000 contact
lens wearers, randomly selected and conducted in November 2014 and
May 2015. These surveys were sponsored by 1-800 CONTACTS and
conducted by an independent market research company. As with the
2015 survey cited above, the Commission has concerns about the
methodology utilized for these surveys but believes the information
may still be suggestive, particularly when viewed in conjunction
with information from other sources and the absence of contradictory
data.
---------------------------------------------------------------------------
Some commenters also cited a 2008 report in a contact lens industry
publication which found that just half of surveyed optometrists
replied, ``yes, to every patient,'' when asked if they routinely
release contact lens prescriptions.\76\
---------------------------------------------------------------------------
\76\ 1-800 CONTACTS (Comment #568), Information Technology &
Innovation Foundation (Comment #40), Utah Retail Merchants
Association (Comment #28) citing Mack, supra note 34. Analogously,
an October 2015 SurveyMonkey survey of 1,329 respondents, sponsored
by online eyewear seller Warby Parker, reported that 47% of
consumers who saw optometrists were not automatically provided with
an eyeglass prescription at the end of the exam. Warby Parker
(Comment #813 on the Ophthalmic Practice Rules), https://www.ftc.gov/policy/public-comments/initiative-624. The patients
surveyed by SurveyMonkey were primarily consumers who purchased
eyeglasses, not contact lenses, but the prescription-release
requirement for eyeglass prescriptions is similar to that for
contact lenses and both eyeglasses and contact lenses are prescribed
by the same categories of eye care professionals. See Ophthalmic
Practice Rules, 16 CFR 456.2.
---------------------------------------------------------------------------
Other commenters stated that even when consumers receive a copy of
their prescription, the prescription information is not always complete
or correct. One online seller of replacement lenses contended that some
prescribers deliberately render prescriptions incomplete by omitting
information, in order to make it more difficult for consumers to buy
lenses from third-party sellers.\77\ According to an internal review of
prescriptions on file with 1-800 CONTACTS, 23% were missing one or more
parameters required to fill an order, and 43% lacked complete contact
information for the prescriber.\78\
---------------------------------------------------------------------------
\77\ LD Vision Group (Comment #544).
\78\ 1-800 CONTACTS (Comment #568) (based on a ``sample of 803
prescriptions on file with 1-800 CONTACTS.''). The Commission was
not provided with the data for this sample, and so cannot judge
whether the data are generalizable. Apart from this internal survey,
the Commission has not received other empirical evidence
demonstrating that prescribers--deliberately or otherwise--failed to
provide patients with complete prescriptions.
---------------------------------------------------------------------------
Such omissions, when they occur, may be intentional, may reflect
clerical or communication errors, or may reflect an imperfect
understanding of the Rule's complete requirements for prescription
release. All such errors could reflect failures to comply fully with
the requirements of the Rule.
The sheer number of verifications conducted by third-party sellers
also may suggest that many consumers are not automatically receiving
their prescriptions from prescribers, or are not receiving complete
prescriptions. Under Section 315.5, verifications are only necessary if
a consumer fails to provide a third-party seller with a complete
prescription. According to discussions with industry, roughly three-
quarters of third-party contact lens sales require prescription
verification, meaning that the consumer did not present a complete
prescription at the time of the attempted purchase. Seemingly contrary
to this data is a survey, conducted on behalf of Johnson & Johnson
Vision Care, Inc., a large contact lens manufacturer, according to
which 61% of consumer respondents said that they provided the retailer
with their prescription the last time they purchased lenses online or
by telephone.\79\ The Commission does not have enough data or insight
to determine if either of these surveys accurately reflects industry
practice. It is possible that some of these consumers received
incomplete or otherwise problematic prescriptions. If so, those
consumers might accurately report that they provided something that
they believed to be a prescription at the time of purchase when, in
fact, the document they provided was not complete or fillable, and
hence (a) required verification and (b) was not a ``prescription'' as
defined by the Rule. Alternatively, some consumers could have received
their prescriptions from
[[Page 88532]]
prescribers but misplaced them, forgot them, or simply thought it
easier to obtain the refraction information from their contact lens
boxes. Whatever the frequency with which each of these possibilities
occurs, it is evident that third-party sellers are presently verifying
a significant percentage of contact lens prescriptions with
prescribers. It is also evident, based on the comments submitted, that
many prescribers feel there are too many verification requests, and
that it would be helpful if more patients provided a copy of their
prescription to sellers rather than rely on the verification
process.\80\
---------------------------------------------------------------------------
\79\ Johnson & Johnson Vision Care, Inc. (Comment #582) (August
2015 telephone survey by APCO Insight for J&J).
\80\ See, e.g., Carroll (Comment #5) (``[Verification] is costly
to my business. the patient should have a written copy of their Rx
to provide to the vendor of their choice.''); Walton (Comment #543)
(``It should be the consumer's responsibility to provide the seller
a full, unexpired contact lens prescription and the doctor
prescribing should not have to be involved in this process. It puts
undue stress on small local businesses to have to respond to
faxes''); Baur (Comment #170) (``If I am already handing patients a
copy of their prescription, why do I have to verify the Rx at
all?'').
---------------------------------------------------------------------------
Another concern raised by commenters is whether consumers are even
fully aware of their right to their prescriptions.\81\ According to the
aforementioned October 2015 survey conducted on behalf of 1-800
CONTACTS, 46% of contact lens wearers were unaware that they had a
right to receive a copy of their prescription, even though the Rule has
been in effect since 2004.\82\ The manner in which this particular
question was phrased in the 1-800 survey,\83\ however, raises
Commission concerns about the validity of, or the weight that should be
accorded to, the results for this question. In particular, the question
is leading, it lacks an ``I don't know'' option, it uses a term--``hard
copy''--which some patients may not understand, and it is phrased in
such a way that it could give rise to social desirability bias,\84\
since respondents might be reluctant to admit that they are unaware of
their rights under federal law. That being said, a response error
resulting from social desirability bias in this instance would more
likely lead to undercounting, or underestimation, of the number of
patients who are unaware they have a right to their prescription. In
other words, the way the question was phrased could make it seem that
more patients are aware of their right than is actually the case, and
it is thus possible that more than 46% of contact lens wearers are
unaware that they have a right to automatically receive their
prescription at the end of their contact lens fitting.
---------------------------------------------------------------------------
\81\ Warby Parker (Comment #593); 1-800 CONTACTS (Comment #568).
\82\ 1-800 CONTACTS (Comment #568), Exhibit B.
\83\ The question was phrased as follows: ``Are you aware that
it is your right under federal law, as a patient to receive a hard
copy of your contact lens prescription from your eye exam
provider?,'' with the only possible answers being Yes or No.
\84\ Social desirability bias is the tendency of survey
respondents to answer questions in a manner that will be viewed
favorably by others.
---------------------------------------------------------------------------
2. Commenter Suggestions for Improving Automatic Prescription Release
Compliance
Some commenters asked the Commission to take specific actions to
increase compliance with the automatic prescription release
requirement.\85\ Some commenters recommended that the Commission
increase the number of enforcement actions it takes against prescribers
who fail to comply with automatic prescription release in order to
``send a message to complacent prescribers.'' \86\ Another suggestion,
put forth by 1-800 CONTACTS and other third-party sellers, is to amend
the Rule to require that, immediately upon completing a contact lens
fitting, prescribers provide patients with an eye care patients' ``Bill
of Rights,'' informing them of their right to their prescription, that
the prescription will be provided without request, and that they have a
right to purchase lenses from the seller of their choice.\87\ Another
commenter, Consumers Union, the policy and advocacy division of
Consumer Reports, suggested that prescribers inform consumers at the
beginning of their visit--as part of the initial paperwork--that they
will provide a prescription at the end of the examination at no
additional cost.\88\
---------------------------------------------------------------------------
\85\ See, e.g., 1-800 CONTACTS (Comment #568); Utah Retail
Merchants Association (Comment #28); Utah State Senator Bramble
(Comment #576); Information Technology & Information Foundation
(Comment #40); Lens.com (Comment #614); Warby Parker (Comment #593).
\86\ 1-800 CONTACTS (Comment #568). See also Utah State Senator
Bramble (Comment #576); Utah Retail Merchants Association (Comment
#28).
\87\ 1-800 CONTACTS (Comment #568). See also Warby Parker
(Comment #593); Lens.com (Comment #614).
\88\ Consumers Union (Comment #677).
---------------------------------------------------------------------------
Other commenters suggested requiring patients to sign an
``Acknowledgment of Release'' document, confirming that they received
their prescriptions.\89\ Prescribers would be required to retain the
signed acknowledgments, which then could be inspected by the Commission
to verify compliance.\90\ One commenter, an Arizona state
representative, said she was considering introducing state legislation
that would mandate such signed acknowledgments for prescribers in her
state.\91\
---------------------------------------------------------------------------
\89\ Lens.com (Comment #614); 1-800 CONTACTS (Comment #568). See
also Arizona State Representative Carter (Comment #545).
\90\ Id.
\91\ Arizona State Representative Carter (Comment #545).
---------------------------------------------------------------------------
3. Analysis of Proposals for Improving Automatic Prescription Release
Compliance and Commission Proposal
Having considered the various comments and suggestions, the
Commission believes that improving compliance with automatic
prescription release would further the goals of the Act. While none of
the five surveys \92\ cited by commenters are definitive on the
question of automatic release compliance, the Commission believes that
the overall weight of evidence in the rulemaking record--including the
surveys, the high number of verifications, the ongoing pattern of
consumer complaints and anecdotal reports, and the industry's long
history of failing to provide prescriptions to patients even when
obligated by state law--indicates that compliance with the automatic
prescription release provision could be substantially improved.
Furthermore, the potential benefits of increasing the number of
patients who receive their prescriptions are substantial: Increased
patient flexibility and choice in shopping for contact lenses; a
reduced number of verification requests, which some prescribers find
burdensome; a reduced likelihood of errors associated with incomplete
prescriptions; and a reduction in the number and complications of
failed attempts at verification. Increasing compliance also is likely
to spur more competition and innovation among contact lens sellers and
manufacturers. It should also reduce the number of attempts by sellers
to verify expired or inaccurate prescriptions, as well as attempts to
verify prescriptions with the wrong prescriber, practices that many
prescribers complained about in their comments.\93\ The cumulative
effect of increased compliance would likely be lower costs and improved
convenience and flexibility for patients, sellers, and prescribers as
well as increased accuracy of prescriptions presented to sellers,
thereby reducing potential consumer harm from inaccurate, expired, or
otherwise invalid prescriptions.\94\
---------------------------------------------------------------------------
\92\ See supra notes 73-76, citing surveys by Survey Sampling
International, Contact Lens Spectrum, and SurveyMonkey.
\93\ See infra Section IV.
\94\ See, e.g., Lens.com (Comment #614) (predicting that
improving automatic prescription release compliance could lead to
lower contact lens prices, since it would reduce verification costs
for both sellers and prescribers).
---------------------------------------------------------------------------
Having determined that it would be beneficial to increase
compliance with
[[Page 88533]]
the automatic prescription release provision, the Commission now
evaluates various proposals put forth by commenters for how to best
achieve this goal.
(a) Proposal To Increase Enforcement
Several commenters suggested that one way to better ensure
automatic prescription release compliance is for the Commission to
become more aggressive about enforcement.\95\ According to 1-800
CONTACTS, ``Prescribers today clearly believe they can disregard their
legal obligations without consequence.'' \96\ 1-800 CONTACTS urged the
Commission to regularly investigate prescriber practices and issue
warning letters or take enforcement actions against prescribers that do
not comply with the automatic prescription release provision.\97\
According to 1-800 CONTACTS, this would not only change the behavior of
the targeted prescribers, but would send a signal to other prescribers
that they need to comply with the Rule.
---------------------------------------------------------------------------
\95\ 1-800 CONTACTS (Comment #568). See also Utah State Senator
Bramble (Comment #576); Utah Retail Merchants Association (Comment
#28).
\96\ 1-800 CONTACTS (Comment #568).
\97\ Id. at 25-26.
---------------------------------------------------------------------------
The Commission recognizes the need for increased enforcement of the
automatic prescription release provision and already has taken some
recent steps to achieve better compliance. For example, in April 2016,
the Commission sent warning letters to 45 contact lens prescribers
after receiving consumer complaints alleging that the prescribers had
violated the Rule, often by failing to provide patients with their
prescriptions automatically.\98\ The Commission acknowledges, however,
that the absence of documentation makes it difficult to determine
whether a prescriber did or did not provide a patient with a
prescription as required, in any particular case. The absence of
documentation also makes it difficult to determine how many times, or
how frequently, a noncompliant party has violated the Rule. Instead,
allegations and denials of Rule violations might often become a matter
of the patient's word against that of the prescriber, making accurate
enforcement decisions, as well as enforcement actions predicated on
those decisions (as opposed to warning letters) more challenging. The
Commission thus believes that enforcement could improve through a
mechanism to increase its ability to assess and verify compliance with
the Rule's automatic prescription release requirements.
---------------------------------------------------------------------------
\98\ Press Release, Fed.Tr. Comm'n, FTC Issues Warning Letters
Regarding the Agency's Contact Lens Rule (Apr. 7, 2016), https://www.ftc.gov/news-events/press-releases/2016/04/ftc-issues-warning-letters-regarding-agencys-contact-lens-rule.
---------------------------------------------------------------------------
(b) Proposal To Require an Eye Care Patients' Bill of Rights or Notice-
Upon-Check-In
A number of commenters recommended that the Commission amend the
Rule to require that prescribers provide patients with written notices
informing them of their right to their prescription. One suggestion,
proposed by three online sellers of eye wear, is that, immediately upon
completion of a contact lens fitting, prescribers provide patients with
a ``Bill of Rights''; that is, a written notice informing patients of
their rights under the Rule, including: (1) The right to receive their
prescriptions; (a) provided promptly and automatically without their
having to request them; (b) at no additional charge; and (2) the right
to purchase their lenses from the seller of their choice.\99\ Another
suggestion, put forth by a consumers' rights organization, is that the
Rule require that, ``the eye doctor inform the consumer at the
beginning of the visit, as part of the initial paperwork, that the
prescription will be provided at the conclusion of the visit at no
additional cost.'' \100\
---------------------------------------------------------------------------
\99\ 1-800 CONTACTS (Comment #568). See also Warby Parker
(Comment #593); Lens.com (Comment #614).
\100\ Consumers Union (Comment #677).
---------------------------------------------------------------------------
Either of these proposals, if implemented and complied with, would
notify consumers of their rights and, presumably, would increase the
percentage of patients who receive prescriptions from their
prescribers. Providing the required document would remind prescribers
and their staffs to provide patients with their prescriptions, and it
would remind patients to ask for their prescriptions in the event that
the prescriber might fail to provide them initially and without a
request, as the Rule and the Act already require.
Since the Commission could draft the specific language for either
the ``Bill of Rights'' or check-in notice, it could ensure that the
notice conveys an accurate explanation of the Rule's automatic
prescription release requirements, something prescribers sometimes fail
to do.\101\ The requirement should also impose a relatively small
burden upon prescribers, since prescribers would only need to provide a
brief, standard form for each patient.
---------------------------------------------------------------------------
\101\ Imprecise word selection by prescribers may, in some
cases, lead prescribers to inadvertently violate the rule. For
example, an eye care practitioner may believe he is complying by
asking patients, ``Do you want a copy of your prescription?'' when,
in fact, such a question is a violation of the automatic release
provision since the prescription is not provided automatically but
rather requires patients to confirm that they want it. This, in
turn, may put patients in an awkward position since they may feel
they are going behind the prescriber's back by shopping for contacts
elsewhere.
---------------------------------------------------------------------------
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 the ``Bill of
Rights'' or check-in notice.
Moreover, the Rule already requires that prescribers provide
patients with copies of their prescriptions, yet diverse complaints
have alleged that many prescribers do not do so. It is at least
possible that many prescribers who now fail to comply with the Rule's
prescription release requirements would also fail to comply with a
requirement to provide a patients' ``Bill of Rights'' or check-in
notice form. Without some mechanism to ensure compliance, a notice by
itself might not provide substantial benefits. The notices recommended
by these proposals would not require the type of prescriber record-
keeping needed to assist the Commission in better Rule enforcement,
either in its current form or as it might be amended. It is thus
possible that adding this requirement would impose an increased burden
on prescribers without providing many tangible, countervailing benefits
to consumers. In light of these considerations, the Commission has
determined not to propose to amend the Rule to require either a Bill of
Rights or notice-upon-check-in.
(c) Proposal To Require a Signed Acknowledgment Form
Another amendment recommended by some commenters is to require that
prescribers present, and patients sign, an ``acknowledgment of
release,'' confirming that they received their prescription at the end
of their contact lens fitting.\102\ Such an acknowledgment would be a
separate, stand-alone document, and prescribers would be required to
retain the signed acknowledgments.\103\
---------------------------------------------------------------------------
\102\ Lens.com (Comment #614); 1-800 CONTACTS (Comment #568).
See also Arizona State Representative Carter (Comment #545).
\103\ Id.
---------------------------------------------------------------------------
An acknowledgment of release would notify consumers of their
prescription portability rights and, in all likelihood, increase the
percentage of patients who receive their prescription from the
prescriber. Providing the required form would also serve as a reminder
to
[[Page 88534]]
prescribers and their staffs to provide patients with their
prescriptions, and serve as a reminder to patients to ask for their
prescription in the event that they receive the acknowledgment form but
not the prescription. Once it becomes an established practice, an
acknowledgment form might also reduce confusion for patients as to when
their contact lens fitting is actually complete, thus reducing the
likelihood of erroneous complaints about a prescriber's perceived
failure to provide a prescription after the completion of a preliminary
examination but when the contact lens fitting has not yet been
completed.
Additionally, since patients would have to affirmatively sign such
an acknowledgment, it is less likely that such a document would go
unnoticed or unread by patients than a ``Bill of Rights'' or notice-
upon-check-in type of document. And perhaps most importantly, requiring
prescribers to retain a signed acknowledgment form would improve the
Commission's ability to verify whether prescribers had complied with
this requirement and had met their obligation to release prescriptions
to their patients. Being able to determine more accurately whether a
particular prescriber had provided a prescription in a particular case
would reduce the number of instances where a filed complaint simply
pits the patient's word against that of the prescriber. It would also
enable the Commission to evaluate the overall rate at which both
individual prescribers and the population of prescribers comply with
the requirement.
One potential drawback to requiring a signed acknowledgment
requirement is the increased recordkeeping burden imposed on
prescribers, since they would have to provide the forms and retain the
signed acknowledgments for a certain period of time.\104\ 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 input
automatically into the electronic record. Furthermore, prescribers also
could scan signed paper copies of the acknowledgment form and store
those forms electronically to lower the costs of this recordkeeping
requirement. Accordingly, the Commission believes that any
recordkeeping burden would be relatively minimal and outweighed by the
benefit of having more patients in possession of their prescriptions.
---------------------------------------------------------------------------
\104\ 1-800 CONTACTS suggested that prescribers should maintain
records of acknowledgments for three years or the length of the
prescription, whichever is longer. 1-800 CONTACTS (Comment #568).
---------------------------------------------------------------------------
(d) Proposal To Require Signage
Another possible Rule revision is to require that prescribers'
offices post conspicuous signage informing consumers of their right to
their prescription. Although this was not specifically suggested by
commenters,\105\ it is currently required by law in California, and the
practice could be expanded via the Rule to apply nationwide.
---------------------------------------------------------------------------
\105\ It was cited in the National Association of Optometrists
and Opticians comment, but not expressly recommended. Comment #549.
---------------------------------------------------------------------------
In California, the Business and Professional Code provides that
each prescriber office must post, in a conspicuous place, a notice
informing patients that eye doctors are required to provide patients
with a copy of their ophthalmic lens prescriptions. The notice also
explains that spectacle prescriptions are released upon the completion
of the exam, and contact lens prescriptions are released upon the
completion of the exam or upon the completion of the fitting
process.\106\
---------------------------------------------------------------------------
\106\ 16 CCR Sec. 1566. California also has an additional state
law, CAL Bus. & Prof. Code Sec. 2554, which essentially requires
the same signage, with the addition of a notice stating, ``Patients
may take their prescription to any eye doctor or registered
dispensing optician to be filled,'' and requiring the inclusion of
complaint contact information for the California Board of Optometry.
---------------------------------------------------------------------------
Such a requirement, if adopted in the Rule, could provide some of
the same benefits of the Bill of Rights, notice-upon-check-in, and
signed acknowledgment proposals in that it would, in theory, notify
consumers of their rights and, presumably, increase the percentage of
patients who receive their prescription from the prescriber. A sign
could also serve as a reminder to patients to ask for their
prescription in the event the prescriber does not provide it.
Furthermore, a sign would impose less of a burden on prescribers than
the other proposals, since it would only have to be posted once, as
opposed to individual copies for each and every patient. Lastly,
enforcing such a provision would be relatively straightforward, since
the Commission could perform spot checks on prescribers' offices to
ensure they have posted the required signage.
On the other hand, the Commission lacks good evidence about the
effects of California's particular version of this requirement, and it
is unclear how many patients actually read posted notices at doctors'
offices, particularly in locations where there are already numerous ads
or other postings about various rights, requirements, and obligations.
It is likely that far fewer patients would learn of their rights from a
single sign--competing for attention with ads and other signage--than
from being handed or shown a document, particularly a document
consumers are required to sign. Moreover, since a sign would not
require a prescriber to interact with each patient, it would serve as
less of a reminder to prescribers and their staff to provide patients
with their prescriptions. And, although it would be relatively
straightforward for the Commission to verify and enforce the signage
requirement, such a requirement would do little to assist the
Commission in verifying or enforcing compliance with the automatic
prescription release provision itself. Furthermore, Commission staff
would have to physically visit prescribers' offices located throughout
the country to verify the signage, resulting in the expenditure of more
Commission resources to monitor compliance.
(e) The Commission's Proposal To Require a Signed Acknowledgment
After consideration of the comments and proposals, the Commission
proposes to add a signed acknowledgment requirement. The Commission
believes such a provision will help inform patients of their right to
their prescriptions, increase the number of patients who receive their
prescriptions and, consequently, increase the number of purchases made
with initial presentations of complete and valid prescriptions, thus
reducing the number of verifications by third-party sellers. The
addition of a signed acknowledgment requirement accomplishes the
desired objectives with little increased burden on prescribers. The
Commission believes that implementation of signed acknowledgments would
best serve several important objectives: Reminding prescribers to
release prescriptions, informing patients of their rights, reducing
misunderstandings, and improving the Commission's verification and
enforcement ability.
The requirement that the prescriber request the patient acknowledge
receipt of the contact lens prescription is triggered once the
prescriber has presented the prescription to the patient. The patient
shall receive the prescription prior to being asked to sign the
acknowledgment form, and signing the acknowledgment form is not a
condition to obtain the prescription. If the patient refuses to sign or
cannot sign the acknowledgment form, the prescriber must note the
refusal or
[[Page 88535]]
inability on the acknowledgment form and must maintain the form.
The acknowledgment form may be either paper or in electronic
format. The acknowledgment form, whether paper or electronic, must be
entitled ``Patient Receipt of Contact Lens Prescription,'' and must
state, ``My eye care professional provided me with a copy of my contact
lens prescription at the completion of my contact lens fitting. I
understand that I am free to purchase contact lenses from the seller of
my choice.'' The acknowledgment form shall be in a format that allows
either conventional or electronic signatures. Prescribers may maintain
copies of the acknowledgment forms in paper or electronically.
The Commission, therefore, proposes to amend Section 315.3 to add
the requirement that upon completion of a contact lens fitting, and
after providing a copy of the contact lens prescription to the patient,
the prescriber shall request that the contact lens patient acknowledge
receipt of the contact lens prescription by signing an acknowledgment
form entitled, ``Patient Receipt of Contact Lens Prescription.'' This
form must state, ``My eye care professional provided me with a copy of
my contact lens prescription at the completion of my contact lens
fitting. I understand I am free to purchase contact lenses from the
seller of my choice.'' In addition, the form must also include the name
of the patient, the patient signature, and the date the form was
signed. In the event that the patient declines to sign the
acknowledgment form, the prescriber shall note the patient's refusal on
the form and sign it. No other statements or information, other than
the address or letterhead of the prescriber, shall be placed on the
acknowledgment form.
The Commission also proposes to amend Section 315.3 to add the
requirement that prescribers maintain the signed acknowledgments for a
period of not less than three years, so that the signed acknowledgments
are available for inspection by the Federal Trade Commission. The full
text of the proposed Rule amendment is located in Section X of this
notice.
4. Additional Mechanisms for Improving Prescription Portability
The increasing number of prescribers who offer patient ``portals''
accessible via the Internet has made it possible for prescribers to
post, and patients to obtain, prescriptions online, while maintaining
the security and privacy of patients' health information.\107\ This,
along with the patient's ability to email prescription copies to
sellers, increases prescription portability. It also could reduce the
verification burden on prescribers, to the extent that patients could
quickly and reliably obtain complete and accurate copies of their
prescriptions,\108\ without making specific requests to their
prescribers for such copies, and to the extent that such prescriptions
could be filled without the seller intervening to verify the
prescriptions directly with the prescribers. In addition, patient
portals do not raise the same concerns expressed by some prescribers
about sharing patient prescription information with third parties,
because patient portals enable the secure sharing of such information
directly with the patients themselves.\109\
---------------------------------------------------------------------------
\107\ Although the Commission lacks data on the use of patient
portals by ophthalmologists or optometrists in particular, the
Commission notes that a recent report to Congress observes that
increasing numbers of physicians and other types of health care
providers are sharing information electronically with their
patients. For example, in 2014, four in 10 office-based physicians
reported sharing information electronically with their patients, and
57% of all physicians reported sharing information directly with
their patients electronically. 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'' 28-30 (2016),
https://www.healthit.gov/sites/default/files/Attachment_1_-_2-26-16_RTC_Health_IT_Progress.pdf.
\108\ Empirical studies of the integrity of electronic
transmission of prescription information chiefly focus on systems
for transmitting prescription drug information and not contact lens
prescriptions. Still, such studies suggest that the adoption of
electronic prescribing greatly reduces the error rate associated
with handwritten paper prescriptions. See, e.g., Rainu Kaushal et
al., ``Electronic Prescribing Improves Medication Safety in
Community-Based Office Practices,'' 25 J. Gen. Intern. Med. 530, 530
(2010) (finding that, ``For e-prescribing adopters, error rates
decreased nearly sevenfold, from 42.5 per 100 prescriptions (95%
confidence interval (``CI''), 36.7-49.3) at baseline to 6.6 per 100
prescriptions (95% CI, 5.1-8.3) one year after adoption (p<0.001).
For non-adopters, error rates remained high at 37.3 per 100
prescriptions.'').
\109\ See, e.g., U.S. Dep't Health & Human Servs., HealthIT.gov,
``Do I Need to Obtain Consent From My Patients to Implement a
Patient Portal?,'' https://www.healthit.gov/providers-professionals/faqs/do-i-need-obtain-consent-my-patients-implement-patient-portal
(noting that HIPAA permits the disclosure of health information to
the patient without requiring the patient's express consent and that
portals are ``an excellent way to afford patients access to their
own information and to encourage them to be active partners in their
health care.'')
---------------------------------------------------------------------------
Accordingly, the Commission believes that the use of patient
portals to provide patients with access to electronic copies of their
prescriptions can benefit prescribers, sellers, and patients. The
Commission encourages prescribers, in addition to providing patients
with a copy of their prescriptions, to make prescriptions available via
patient portals in accordance with federal and state law, including HHS
guidance. Uploading prescriptions to patient portals will make it
easier for patients to access their prescriptions and, consequently, to
transmit them to sellers when purchasing lenses. This, in turn, may
substantially increase the accuracy of seller-filled orders and reduce
the verification burden on prescribers.\110\ To facilitate the
likelihood that patient portals will increase prescription portability,
the patient portal should be configured to allow the patient to
download, save, and print the prescription, as well as to allow the
patient to email, or otherwise transmit, prescriptions directly to a
seller.
---------------------------------------------------------------------------
\110\ See Kaushal, supra note 108.
---------------------------------------------------------------------------
At this time, the Commission does not have enough information to
determine whether solely posting a contact lens prescription to a
patient portal is sufficient to satisfy the Rule's obligation for
prescribers to provide copies of contact lens prescriptions to
patients. However, the Commission seeks comment on the use and adoption
of patient portals, as well as the potential ability for such
technology to allow prescribers to comply with the automatic
prescription release requirement of the Rule.
B. Section 315.3(a)(1)--Additional Copies of Prescriptions
Some commenters requested that the Commission amend the Rule to
expressly obligate prescribers to provide duplicate prescription copies
to patients upon request.\111\ According to Consumers Union, such a
requirement would provide ``additional protection for situations in
which the eye doctor neglects to provide the prescription during the
visit, as well as for situations in which the prescription is misplaced
by the consumer.'' \112\ Likewise, the health and safety organization
Prevent Blindness asserted that duplicate copies should be available
upon request since ``[i]t is a basic consumer right to own one's
prescriptions.'' \113\
---------------------------------------------------------------------------
\111\ Prevent Blindness (Comment #13); Consumers Union (Comment
#677).
\112\ Consumers Union (Comment #677).
\113\ Prevent Blindness (Comment #13).
---------------------------------------------------------------------------
During the initial rulemaking, the Commission stated that the Act
neither requires prescribers to release, nor prohibits them from
releasing, additional copies of the prescription.\114\ At that time,
the Commission declined
[[Page 88536]]
to require or prohibit the release of additional copies of the
prescription.\115\
---------------------------------------------------------------------------
\114\ 69 FR at 40492.
\115\ Id.
---------------------------------------------------------------------------
Upon consideration of the comments, the rulemaking record, and a
re-examination of the language of the Act itself, the Commission now
clarifies that the Act and the Rule require that prescribers provide
patients with additional copies of their prescriptions upon request.
Accordingly, the Commission believes there is no need to amend the
Rule, but seeks comment on this clarification.
This determination is supported by a number of considerations.
First, as noted above, during the initial rulemaking, the Commission
stated that the Act neither requires nor prohibits additional copies of
the prescription. However, this statement was made in response to two
commenters who recommended that the prescription release obligation be
limited to one release per patient. Thus, the Commission did not fully
consider whether additional copies should be required, only that the
Act did not expressly limit patients to one copy.
Second, the Act and the Rule require that prescribers provide or
verify the patient's prescription when so ``directed by any person
designated to act on behalf of the patient.'' \116\ This provision has
been interpreted to mean that prescribers must provide a prescription
whenever a patient authorizes an agent to request one, even if the
patient previously received a prescription copy from the
prescriber.\117\ The Commission's Division of Advertising Practices,
which administers and enforces the Rule, arrived at this interpretation
based upon the plain language of the Act and Rule, as well as upon
recognition that when consumers want to order contact lenses, ``some
consumers have neither their prescription nor sufficient information
about their prescription for [the seller] to prepare a proper
verification request.'' \118\ Based upon this interpretation, duly
authorized patients' agents (sellers) are able to obtain a duplicate
copy of the patients' prescription upon request. In addition, patients,
acting as their own agents, are able to obtain a duplicate copy of
their prescription upon request.\119\
---------------------------------------------------------------------------
\116\ 15 U.S.C. 7601(a)(2); 16 CFR 315.3(a)(2).
\117\ See Staff Opinion Letter to the American Optometric
Association Providing Guidance Regarding How Contact Lens
Prescribers Should Respond to Requests for Patients' Contact Lens
Prescriptions, Pursuant to the Fairness to Contact Lens Consumers
Act and the Contact Lens Rule, Oct. 4, 2006 (stating that if the
seller is an agent of the consumer, ``the prescriber has an
obligation under the FCLCA and the Contact Lens Rule to provide the
consumer's prescription'' to the seller) https://www.ftc.gov/public-statements/2006/10/requests-contact-lens-prescribers-provide-patients-contact-lens; 1-800 CONTACTS (Comment #568), Exhibit E
(same).
\118\ Id. The American Optometric Association takes exception to
this interpretation, and argues that if Congress meant for retailers
to be able to demand patients' prescription at any time, then ``the
entire verification process would have been all but unnecessary.''
Comment #644. The Commission disagrees with this contention,
however, because verification is simply an additional option for
ensuring that patients have a valid prescription, one that is faster
and less paper-intensive, for both the seller and prescriber, than
requiring that the prescriber always provide the complete patient
prescription. Moreover, the Act and the Rule state that the
prescriber must provide or verify the contact lens prescription as
directed by the patient's agent, thus leaving it up to the agent, if
so authorized by the patient, to decide which method is preferable.
\119\ 15 U.S.C. 7601(a)(2); 16 CFR 315.3(a)(2). In addition, the
HIPAA Privacy Rule right of access requires a covered prescriber to
provide a copy of a prescription to the patient upon request or to
another person she designates. See 45 CFR 164.524(c)(3). See infra
Section V.C.
---------------------------------------------------------------------------
Furthermore, as discussed earlier, because the Commission believes
that many prescribers are not providing patients with their
prescriptions upon completion of their contact lens fitting,\120\ there
is additional justification for ensuring that patients are able to
obtain copies of their prescription when necessary. The Commission
therefore believes that requiring prescribers to provide additional
copies of contact lens prescriptions to patients upon request is
consistent with the language and intent of the Act: Providing
prescription portability while protecting consumer health. Consumers
with ongoing access to their prescriptions will be able to obtain the
correct contact lenses from the seller of their choosing.
---------------------------------------------------------------------------
\120\ See supra Section III.A.1.
---------------------------------------------------------------------------
C. Section 315.3(a)(2)--Provide or Verify the Contact Lens Prescription
Section 315.3(a)(2) of the Rule requires that prescribers shall, as
directed by any person designated to act on behalf of the patient,
provide or verify the contact lens prescription by electronic or other
means.\121\
---------------------------------------------------------------------------
\121\ 16 CFR 315.3(a)(2).
---------------------------------------------------------------------------
1. Sellers Designated To Act on Behalf of Patients
In addition to the obligation to release the prescription to the
patient at the completion of a contact lens fitting, the Rule also
requires prescribers to provide the contact lens prescription to third
parties acting on behalf of the patient.\122\ Accordingly, some
sellers, at the direction of their customers, have requested copies of
prescriptions from prescribers rather than just verifications of
prescriptions.\123\
---------------------------------------------------------------------------
\122\ Id.
\123\ See, e.g., 1-800 CONTACTS (Comment #568).
---------------------------------------------------------------------------
Because this practice historically has been a source of confusion
for some eye care practitioners, the staff clarified, in a 2006 letter
to the American Optometric Association, that the Rule obligates a
prescriber to provide the consumer's complete prescription to a third-
party seller if the consumer has authorized that seller as an
agent.\124\ In its letter, FTC staff also made clear that the Act and
the Rule do not permit the prescriber to require that sellers provide
written documentation of the patient's authorization before providing
the seller with a copy of the patient's prescription.\125\ In response,
the American Optometric Association has provided guidance to its
members that they must comply with this provision of the Rule.\126\
---------------------------------------------------------------------------
\124\ Staff Opinion Letter, supra note 116.
\125\ The opinion letter also explains that neither the Health
Insurance Portability and Accountability Act (``HIPAA'') of 1996 nor
its implementing regulations require such written documentation of
the authorization.
\126\ American Optometric Association, Summary of Advisory from
AOA General Counsel Regarding FCLCA Enforcement Update, Sept. 1,
2015, http://www.aoa.org/Documents/advocacy/FTC_guidance_on_Rx_releases.pdf.
---------------------------------------------------------------------------
This option may be gaining popularity with at least one seller. As
explained by 1-800 CONTACTS, ``[d]ue in large part to poor prescriber
compliance with prescription release requirements, many customers
cannot provide a third-party seller with [a] copy of their contact lens
prescription at the time they place their order.'' \127\ 1-800 CONTACTS
also pointed out that this option benefits consumers because with a
copy of the prescription on file, it can ship orders without any delay
and without having to contact the prescriber each time the consumer
wishes to purchase lenses.\128\
---------------------------------------------------------------------------
\127\ Comment #568.
\128\ Id.
---------------------------------------------------------------------------
In its comment, however, the American Optometric Association argued
that ``[r]equests by sellers directly to physicians for copies of
patient prescriptions should be disfavored.'' \129\ The American
Optometric Association asserted that sellers should use the
verification system instead because verification requests consume less
time than the retrieval, copying, and transmission of the actual
prescription to sellers. The American Optometric Association
acknowledged that it believes that the Rule's verification system needs
improvement, but pointed out that it contains safeguards that requests
for
[[Page 88537]]
copies of prescriptions do not.\130\ The American Optometric
Association stated that sellers would only need to request a copy of a
prescription directly from the prescriber when the patient does not
submit the prescription and the patient is unable to provide any
information about the prescription to the seller in order to permit use
of the verification process.\131\
---------------------------------------------------------------------------
\129\ Comment #644.
\130\ Although the American Optometric Association comment did
not specifically mention the safeguards, it is likely that the
comment is referring to fact that if a prescription verification
request lists a quantity of lenses that is excessive, the prescriber
can deem such a request ``inaccurate.''
\131\ Comment #644.
---------------------------------------------------------------------------
Few other prescribers addressed this issue directly in their
comments to this Rule review.\132\ However, the Commission also has
received anecdotal reports that prescribers are still confused about
this provision of the Rule, and some comments appear to conflate
requests for a copy of a prescription with an incomplete verification
request. For example, some prescribers complained that 1-800 CONTACTS
was sending them incomplete verification requests, but instead it
appears that 1-800 CONTACTS was sending the prescriber a request for
the patient's prescription.
---------------------------------------------------------------------------
\132\ Diener (Comment #6) (the ``rule should be restricted to
use only upon recent patient request, not used in perpetuity to
obtain records for marketing purposes''); Vidulich (Comment #612)
(silent on the issue, but attaching request for a copy of the
prescription).
---------------------------------------------------------------------------
The Commission declines to adopt the American Optometric
Association's suggestion that requests for copies of a prescription by
a duly authorized seller be discouraged. The plain language of the Act
and the Rule provide for this method of acquiring a prescription and
the Association provided no evidence demonstrating that providing a
copy of a prescription to a seller, rather than verifying a
prescription, was significantly more burdensome to prescribers. As to
the contention that the verification system contains safeguards that
requests for prescriptions do not, the Commission points out that a
prescription provided by a prescriber directly to the seller would
necessarily include all relevant information and would avoid some of
the issues raised by commenters about the flaws of the verification
system. In addition, the copy of the prescription provided by the
prescriber to the seller would contain an expiration date, which also
serves as a safeguard against the improper dispensing of contact
lenses.
Despite clarifications that prescribers must provide copies of
prescriptions to sellers when authorized by the patient, 1-800 CONTACTS
complained in its comment that in its experience, about half of
prescribers ``routinely ignore [their] requests'' for a copy of a
patient's prescription.\133\ To address problems encountered by
authorized agents in procuring copies of prescriptions, as well as
ongoing prescriber confusion about this provision, two commenters
proposed amending Section 315.3 ``to require that in response to an
authorized request, the prescriber send the prescription to the agent
(by mail, facsimile or a digital image of the prescription that is sent
via electronic mail) within eight business hours as currently defined
under the [Rule].'' \134\
---------------------------------------------------------------------------
\133\ Comment #568.
\134\ Id.; see also Warby Parker (Comment #593).
---------------------------------------------------------------------------
In support of its proposal, 1-800 CONTACTS stated that,
``[e]vidence shows that in about half the cases, prescribers ignore and
never respond to 1-800's authorized requests for a copy of a customer's
prescription.'' \135\ 1-800 CONTACTS does not specify this evidence in
its comment. However, in a 2006 letter to the Commission, 1-800
CONTACTS asserted that an audit of 264 requests for a copy of a
customer's prescription shows that 46% of prescribers did not respond
within five business days.\136\ The other commenter, Warby Parker,
provided no evidence in support of its proposal.\137\
---------------------------------------------------------------------------
\135\ Comment #568.
\136\ See 1-800 CONTACTS (Comment #568), Exhibit E.
\137\ Warby Parker (Comment #593). Warby Parker also proposed
that the prescriber be required to maintain a log recording the date
and time a patient's prescription was requested and released to the
authorized agent.
---------------------------------------------------------------------------
The Act and the Rule currently require the prescriber to provide a
copy of a prescription to an authorized third party, but is silent on
the timing of the response. The proposed modification would require
prescribers to provide a prescription within eight business hours, the
same amount of time that prescribers are afforded to respond to a
verification request. The Commission notes, however, that there is a
qualitative difference between responding to a verification request as
opposed to providing a copy of a prescription. First, if the
verification request is correct, the prescriber need take no
action.\138\ Second, the proposed modification would require the
prescriber to act within eight business hours, and if the prescriber
did not act, or was unable to act, she would be in violation of the
Rule. The eight-business-hour window for verification does not place
the prescriber in such jeopardy. If the prescriber is unable to respond
to a verification request in a timely fashion--for whatever reason--the
request is verified, but the prescriber is not in violation of the
Rule.
---------------------------------------------------------------------------
\138\ Based on discussions with industry, it appears that the
vast majority of verification requests are passively verified, with
no prescriber action taken.
---------------------------------------------------------------------------
At this time, the Commission has determined that the existing
rulemaking record is not sufficient to support a Rule modification
requiring a prescriber to respond to a request for a copy of a
prescription within eight business hours. Accordingly, the Commission
requests additional information from commenters on the costs and
benefits of imposing a timeframe for prescribers to respond to requests
from authorized third parties for a copy of a patient's prescription.
The Commission also seeks comment on the appropriate amount of time for
a prescriber to respond to prescription requests.\139\
---------------------------------------------------------------------------
\139\ Another commenter, Opternative, a telehealth provider,
proposed that the Commission ``consider expanding the verification
requirements so that prescribers' obligations also apply to any
other third party, including other prescribers, that is authorized
by the patient.'' Comment #648. Section 315.3 explicitly states that
the prescriber shall provide or verify the contact lens
prescription, ``as directed by any person designated to act on
behalf of the patient.'' Nothing in the Act or Rule precludes the
construction of ``any person'' from including other prescribers.
Furthermore, the HIPAA Privacy Rule permits a ``covered entity'' to
use or disclose protected health information without patient
authorization ``for treatment, payment, or health care operations.''
45 CFR 164.506. The Commission does not believe that the Rule needs
any modification on this issue.
---------------------------------------------------------------------------
IV. Prescriber Verification
Section 315.5 of the Rule provides the framework under which
sellers may dispense contact lenses to consumers and requires sellers,
before selling contact lenses, to either obtain a copy of the patient's
prescription or verify the prescription. Section 315.5 also sets forth
the procedures for obtaining such verification as well as seller
recordkeeping obligations.
A. Section 315.5(a)--Prescription Requirement
Section 315.5(a) of the Rule provides that a seller may sell
contact lenses only in accordance with a contact lens prescription for
the patient that is presented to the seller by the patient or
prescriber directly or by facsimile; or verified by direct
communication. This provision was taken verbatim from the Act.\140\
---------------------------------------------------------------------------
\140\ 69 FR at 40495; see also 5 U.S.C. 7603(a).
---------------------------------------------------------------------------
1. Presentation of Prescriptions ``Directly or by Facsimile''
In the initial rulemaking, the Commission determined that the
``directly or by facsimile'' language of section 4(a)(1) of the Act
allowed the
[[Page 88538]]
patient or prescriber to present a prescription by mail, by facsimile,
or through a digital image of the prescription that is sent via
electronic mail.\141\ The Commission also decided at that time not to
include ``substantially equivalent future technologies'' within the
scope of acceptable direct presentation mechanisms.\142\ In doing so,
the Commission noted that section 4(a)(1) of the Act did not expressly
reference or contemplate future technologies and the Commission was not
aware of other technologies that met the statutory standard. The
Commission declined at that time to include future technologies that
``do not involve an exact copy of the prescription within the scope of
acceptable direct presentation mechanisms.'' \143\
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\141\ 69 FR at 40495. The Commission also concluded that
presentation of the prescription information from the consumer to
the seller by telephone or by email (other than an email containing
a digital image of the prescription) did not meet the ``directly or
by facsimile'' standard imposed by the Act.
\142\ Id.
\143\ Id.
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Since implementation of the Rule in 2004, technological advances--
including many spurred by federal and state health information
technology initiatives \144\--have fostered the proliferation of
patient portals, through which health care providers can securely share
medical information, such as prescription information, directly with
patients and certain third parties. The use of patient portals for
presentation of contact lens prescriptions to sellers may provide many
benefits to consumers and competition. When using a portal, the patient
or prescriber will have direct access to a current, exact copy of the
contact lens prescription, reducing the chance that an inaccurate or
expired prescription might be presented to the seller. The use of
patient portals may also reduce costs for prescribers, patients, and
sellers by making it easier and more efficient for patients to share
and present contact lens prescriptions, and by reducing the number of
verification requests placed on prescribers.
---------------------------------------------------------------------------
\144\ 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 HITECH Act of 2009--Title XIII
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 (Recovery Act), Public Law 111-5, Sec. 4101(a), 4101(b), and
4202 (2009) (Medicare incentives for eligible professionals,
Medicare incentives for hospitals, and Medicaid provider payments,
respectively). According to a recent report by the U.S. Department
of Health & Human Services, 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'' 18 (2016),
https://www.healthit.gov/sites/default/files/Attachment_1_-_2-26-16_RTC_Health_IT_Progress.pdf. Regarding patient portals in
particular, see, e.g., U.S. Dep't Health & Human Servs., Office of
the National Coordinator for Health Information Technology, ``ONC
Patient Engagement Playbook,'' https://www.healthit.gov/playbook/pe/introduction/.
---------------------------------------------------------------------------
Because of these potential benefits, the Commission has made an
initial determination that the provision ``directly or by facsimile''
includes the use of online patient portals by patients and prescribers
to present contact lens prescriptions to sellers. In doing so, the
Commission notes that the use of a patient portal necessarily involves
``an exact copy of the prescription within the scope of acceptable
direct presentation mechanisms.'' \145\ The Commission seeks comment on
this clarification and requests that commenters provide information
about whether the Commission should consider any other issues related
to the presentation of prescriptions to sellers.
---------------------------------------------------------------------------
\145\ 69 FR at 40495.
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2. ``Verified by Direct Communication''
Some individual commenters recommended that the Commission revise
the Rule to remove verification by direct communication, and argued
that the sale of contact lenses should be conditioned upon presentation
of a written prescription by the consumer to the seller. These
commenters noted that consumers are already being provided with a
written prescription as required by the Rule, and that requiring
prescribers to verify prescriptions with the seller as well was
redundant, time-consuming and burdensome.\146\ Other commenters noted
that with electronic means such as email and phone cameras readily
available, the consumer should be responsible for presenting the
prescription to the seller rather than having the prescriber verify the
prescription.\147\ Other commenters argued that contact lens
prescriptions should be treated the same way as prescriptions for
medications, and that consumers should only be able to obtain contact
lenses by presenting a written prescription.\148\ Some commenters also
stated that relying on a written prescription to dispense lenses,
rather than prescriber verification, would close loopholes in the
verification framework that may allow consumers to obtain lenses
without a valid, unexpired prescription.\149\
---------------------------------------------------------------------------
\146\ Carroll (Comment #5), Driscoll (Comment #67); Kirk
(Comment #131); Kalman (Comment #150); Baur (Comment #170); Bricker
(Comment #195); Ahn (Comment #215); Comer (Comment #221); Kubo
(Comment #234); Sanders (Comment #235); Williston (Comment #252);
Campbell (Comment #348); Falcon (Comment #505); Walton (Comment
#543).
\147\ Kiener (Comment #74); Kubo (Comment #234); McWilliams
(Comment #362); Falcon (Comment #505); Pham (Comment #641).
\148\ Driscoll (Comment #67); Moody (Comment #92); Filandro
(Comment #129); Kirk (Comment #131); Kalman (Comment #150); Boyer
(Comment #246); Bolenbaker (Comment #357).
\149\ Driscoll (Comment #67); Dieckow (Comment #151); Ahn
(Comment #215); Sanders (Comment #235); Smith (Comment #319).
---------------------------------------------------------------------------
The language of Section 315.5(a)(2) was taken verbatim from the
Act.\150\ Because Congress decided to structure the prescription
verification framework to allow for either the direct presentation of a
prescription to a seller or, alternatively, the verification of a
prescription by direct communication, elimination of verification by
direct communication is beyond the scope of this rule review.
---------------------------------------------------------------------------
\150\ 69 FR at 40495; see also 5 U.S.C. 7603(a).
---------------------------------------------------------------------------
3. Automated Telephone Calls as a Method of Direct Communication
The Commission received numerous comments objecting to contact lens
sellers' use of automated telephone calls as a method to communicate
verification requests.\151\ These commenters, who often refer to these
automated telephone calls as robocalls, are largely prescribers,
students of optometry, and associations whose members are prescribers.
---------------------------------------------------------------------------
\151\ The American Optometric Association pointed to the
public's general disfavor of robocalls, noting that they are
commonly understood to be an abuse of telephone communication, one
for which companies have been fined millions of dollars. Comment
#644. The FTC disagrees with this characterization of automated
seller verification calls. Contact lens seller verification calls
are not sales calls covered by the Telemarketing Sales Rule
(``TSR''), 16 CFR 310, which prohibits certain robocalls. In
addition, the TSR does not apply to most business-to-business
communications. 16 CFR 310.6(b)(7).
---------------------------------------------------------------------------
Commenters described problems arising from the use of automated
telephone calls,\152\ and some
[[Page 88539]]
commenters called for an outright ban of the use of such calls.\153\ A
number of commenters indicate that the automated verification calls are
difficult to understand or confusing \154\ or do not provide all of the
information required to be a valid request.\155\ Some optometrists or
state optometric associations, many of which consist of or represent
small businesses,\156\ complain that these calls are too long and time
consuming,\157\ disturb their practices, take time away from providing
care and attention to their patients, and make the phone lines
unavailable for their patients.\158\ Commenters explained that part of
the reason the automated calls are so disruptive is that the caller
continuously redials until a message is fully communicated.\159\ In
response to the recurring disruption, one prescriber stated that his
office simply ignores the robocalls.\160\
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\152\ E.g., Stahl (Comment #19); Lum (Comment #21); Peterson
(Comment #22); Borsky (Comment #26); Matthews (Comment #25); Maanum
(Comment #23); Chriqui (Comment #31); Hodes (Comment #42); Dodge
(Comment #44); Virginia Optometric Association (Comment #46);
Alabama Optometric Association (Comment #48); Howe (Comment #53);
Iowa Optometric Association (Comment #79); Michigan Optometric
Association (Comment #86); Mirkin (Comment #111); California
Optometric Association (Comment #119); Hicks (Comment #256); Leach
(Comment #257); Chang (Comment # 258); Pentacost (Comment #268);
Easton (Comment #432); Koch (Comment #539); Connecticut Association
of Optometrists (Comment #560); Lueng (Comment #607); Wu (Comment
#608); Vidulich (Comment #612); Lai (Comment #620); Coalition for
Patient Vision Care Safety (Comment #621); Pechko (Comment #628);
American Optometric Association (Comment #644); Rubow (Comment
#649); Liu (Comment #656); Louie (Comment #657); Fong (Comment
#669); Vo (Comment #673).
\153\ E.g., Virginia Optometric Association (Comment #16); Stahl
(Comment #19); Lum (Comment #21); Peterson (Comment #22); Maanum
(Comment #23); Matthews (Comment #25); Borsky (Comment #26); Chriqui
(Comment #31); Hodes (Comment #42); Dodge (Comment #44); Alabama
Optometric Association (Comment #48); Iowa Optometric Association
(Comment #79); Michigan Optometric Association (Comment #86);
California Optometric Association (Comment #119); Hicks (Comment
#256); Leach (Comment #257); Chang (Comment # 258); Easton (Comment
#432); New Mexico Optometric Association (Comment #211); Koch
(Comment #539); Connecticut Association of Optometrists (Comment
#560); Tennessee Association of Optometric Physicians (#575);
Colorado Association of Optometrists (Comment #584); Lueng (Comment
#607); Wu (Comment #608); Vidulich (Comment #612); Lai (Comment
#620); Coalition for Patient Vision Care Safety (Comment #621);
Pechko (Comment #628); American Optometric Association (Comment
#644); Liu (Comment #656); Louie (Comment #657); Fong (Comment
#669); Vo (Comment #673).
\154\ E.g., Stahl (Comment #19); Lum (Comment #21); Peterson
(Comment #22); Borsky (Comment #26); Matthews (Comment #25); Maanum
(Comment #23); Chriqui (Comment #31); Hodes (Comment #42); Dodge
(Comment #44); Virginia Optometric Association (Comment #46);
Alabama Optometric Association (Comment #48); Howe (Comment #53);
Iowa Optometric Association (Comment #79); Michigan Optometric
Association (Comment #86); Mirkin (Comment #111); California
Optometric Association (Comment #119); Hicks (Comment #256); Leach
(Comment #257); Chang (Comment # 258); Easton (Comment #432); Koch
(Comment #539); Connecticut Association of Optometrists (Comment
#560); Lueng (Comment #607); Wu (Comment #608); Vidulich (Comment
#612); Lai (Comment #620); Coalition for Patient Vision Care Safety
(Comment #621); Pechko (Comment #628); American Optometric
Association (Comment #644) (stating they have often received
complaints over the last ten years from optometrists that robocalls
from 1-800 CONTACTS were difficult to understand); Rubow (Comment
#649) (stating that if the entire recorded message is not completed
within the allotted time on the answering machine, they then receive
a message from an actual live person where the person speaks so fast
that it requires playing back the message four or five times in
order to get all the information); Liu (Comment #656); Louie
(Comment #657); Fong (Comment #669);Vo (Comment #673).
\155\ Virginia Optometric Association (#46); Iowa Optometric
Association (Comment #79) (stating robocalls too often provide
incomplete information); Hicks (Comment #256); Pentacost (Comment
#268) (stating automated messages start playing well before the
voicemail begins recording so that the office does not catch the
name of the patient or which company left the message); Connecticut
Association of Optometrists (Comment #560) (stating robocalls too
often provide incomplete information); Coalition for Patient Vision
Care Safety (Comment #621) (stating robocallers leave voice messages
without contact information and may be cut off before conveying in
entirety the patient's information); American Optometric Association
(Comment #644) (stating they have often received complaints over the
last ten years from optometrists that robocalls from 1-800 CONTACTS
did not include all of the necessary information to confirm a
prescription).
\156\ E.g., Pennsylvania Optometric Association (Comment #46);
Iowa Optometric Association (Comment #79); Connecticut Association
of Optometrists (Comment #560); Tennessee Association of Optometric
Physicians (Comment #575); Rubow (Comment #649).
\157\ E.g., Stahl (Comment #19); Lum (Comment #21); Peterson
(Comment #22); Maanum (Comment #23); Matthews (Comment #25); Borsky
(Comment #26); Iowa Optometric Association (Comment #79); Lai
(Comment #620); Chriqui (Comment #31); Hodes (Comment #42); Dodge
(Comment #44); Plumb (Comment #219); Hicks (Comment #256); Leach
(Comment #257); Chang (Comment # 258); Easton (Comment #432); Koch
(Comment #539); Tennessee Association of Optometric Physicians
(#575); Lueng (Comment #607); Wu (Comment #608); Vidulich (Comment
#612); Coalition for Patient Vision Care Safety (Comment #621);
Pechko (Comment #628); Liu (Comment #656); Louie (Comment #657);
Fong (Comment #669); American Optometric Association (Comment #644);
Vo (Comment #673).
\158\ Easton (Comment #432); Louie (Comment #657). See also Iowa
Optometric Association (Comment #79) (explaining the need to protect
small businesses from disruptive calls that interfere with treating
patients and tie up phones); Pham (Comment #232); Tennessee
Association of Optometric Physicians (Comment #575); Michigan
Optometric Association (Comment #86).
\159\ See, e.g., Wisconsin Optometric Association (Comment #30);
Pennsylvania Optometric Association (Comment #46); New Mexico
Optometric Association (Comment #211); Tennessee Association of
Optometric Physicians (Comment #575).
\160\ Scolin (Comment #369).
---------------------------------------------------------------------------
Other commenters mentioned that sellers provide the patient name
several sentences into, or at the very end of, the verification
request, making it difficult for prescribers' offices to respond
efficiently and to verify the prescription in real time.\161\ Some
commenters also complained that the automated calls come during
business hours when they are busy with patients.\162\ Meanwhile, other
commenters complain that the calls come in during non-business hours,
and express concern that as a result, sellers may release the contact
lenses to patients without the prescriber having time to confirm the
prescription.\163\
---------------------------------------------------------------------------
\161\ Brauer (Comment #68); Kalman (Comment #150); Egger
(Comment #163); Plumb (Comment #219); Rosemore (Comment #468).
\162\ See, e.g., Chang (Comment #126); Scolin (Comment #369);
Tennessee Association of Optometric Physicians (#575).
\163\ Connecticut Association of Optometrists (Comment #560);
Colorado Optometric Association (Comment #584).
---------------------------------------------------------------------------
Due to the aforementioned problems with automated telephonic
verification requests, the Coalition for Patient Vision Care Safety
asserted that prescribers are often unable to provide the proper
verification of the patient's prescription information within eight
business hours, triggering the passive verification. As a result,
patients may receive contact lenses based on outdated or incorrect
prescription information.\164\ The Coalition stated that ``the fact
that patients are receiving contact lenses based on incorrect,
outdated, or unverified prescription information runs counter to the
FDA's medical device safety standards, and can also lead to serious
vision issues.'' \165\
---------------------------------------------------------------------------
\164\ Comment #621. See also Iowa Optometric Association
(Comment #79); Chakuroff (Comment #189); Bricker (Comment #195);
Spaeth (Comment #486).
\165\ Comment #621.
---------------------------------------------------------------------------
On the other hand, 1-800 CONTACTS requested the Commission retain
the use of automated phone systems as an acceptable form of direct
communication for verification purposes. It argued that changing the
status quo would be ``unjustified, contrary to congressional intent and
not in the interest of consumers.'' \166\ According to 1-800 CONTACTS,
it has experimented with other forms of direct communication and
concluded that ``a well-functioning automated system that incorporates
the latest technology is the most efficient means of handling the large
volume of verification requests that are required today.'' \167\ 1-800
CONTACTS indicated it has invested significant resources into the
development of a system that is less subject to human error, allows
accurate information to be given consistently to every prescriber, and
provides assurance that it is compliant with the Rule. The company
claimed that its system has an automated voice that is clear and easy
to understand, and contains user-friendly options, such as the
opportunity to pause the verification script or to request the system
call back at a later time. 1-800 CONTACTS'
[[Page 88540]]
comment also noted that, while its messages are automated, calls are
initiated by live agents to guarantee that all calls are placed to the
intended prescribers.\168\ 1-800 CONTACTS also asserted that when a
message is left on an answering machine, the live agent remains on the
line during the entire automated message to ensure that the complete
message is conveyed to the prescriber.\169\
---------------------------------------------------------------------------
\166\ Comment #568.
\167\ Id.
\168\ Id.
\169\ Id.
---------------------------------------------------------------------------
According to 1-800 CONTACTS, each week it places approximately
100,000 calls to prescribers to verify prescriptions. The complete
phone script for an automated verification call from 1-800 CONTACTS is
2 minutes, 29 seconds (149 seconds) in length, and prescribers familiar
with the system have the option to skip the first 48 seconds of the
message to reduce the total time of the message to 1 minute, 41 seconds
(101 seconds). 1-800 CONTACTS indicated that the average prescriber
receives only one verification request per week from the company,\170\
and the highest volume office in its records received, on average, six
verification requests per week in 2014.\171\ The company explained that
it places verification calls as it receives orders, and that it
receives orders 24 hours a day, seven days a week, with many orders
coming in on weekends or during evening hours. The company further
explained that it leaves verification messages shortly after its
receipt of orders because a continuous call process is ``logistically
efficient and prevents a shipping bottleneck at a single hour each
day.'' \172\
---------------------------------------------------------------------------
\170\ However, if the call is not completed, 1-800 CONTACTS will
call the prescriber again. Therefore, one verification request may
result in more than one call.
\171\ Id.
\172\ Id.
---------------------------------------------------------------------------
Regardless of when it places the verification call to the
prescriber, however, 1-800-CONTACTS stated that it never ships an order
under the passive verification system before passage of eight business
hours. The company added that in almost 30% of verification requests,
prescribers hang up on verification calls.\173\
---------------------------------------------------------------------------
\173\ Comment #187. See also Consumers Union (Comment #677)
(calling prescriber hang-ups a reported problem).
---------------------------------------------------------------------------
The Commission did not receive other comments from contact lens
sellers about their use of automated verification systems to verify
prescriptions.\174\ Consumers Union, the policy and advocacy division
of Consumer Reports, also commented in support of automated calling
systems, stating that such systems, of which eye doctors should now be
aware, are a reasonable means for a retailer to efficiently handle a
large volume of prescription requests. Consumers Union also stated that
most eye doctors' offices have automated answering systems and it
believed they could set up an efficient means for recording the
verification request information without significant burden.\175\
---------------------------------------------------------------------------
\174\ Warby Parker, an online seller of eyeglasses, commented on
its support of the use of automated phone systems as a form of
direct communication for verification purposes. Comment #593.
\175\ Comment #677.
---------------------------------------------------------------------------
The Act expressly authorizes sellers to send prescription
verification requests by direct communication \176\ and defines
``direct communication'' to include communication by telephone,
facsimile, or electronic mail.\177\ In previously considering this
issue, the Commission noted that telephone is commonly understood to
include automated telephone systems. The Commission therefore concluded
in the initial rulemaking that ``it would thus seem to be contrary to
Congressional intent to prohibit the use of this technology.'' \178\
Nevertheless, then and now, the Commission emphasizes that automated
telephone systems must fully comply with all applicable Rule
requirements in order to transmit valid verification requests.
---------------------------------------------------------------------------
\176\ 15 U.S.C. 7603(a)(2).
\177\ 15 U.S.C. 7603(g).
\178\ 69 FR at 40489.
---------------------------------------------------------------------------
For example, any automated verification request must provide
complete verification request information as required under section
315.5(b),\179\ and this information must be either received by a person
on the telephone or otherwise received in full (e.g., all of the
requisite information is left on a telephone answering machine). A
request delivered by an automated telephone system does not comply with
the Rule if it is not delivered in a volume and cadence that a
reasonable person can understand, or if it contains incomplete
verification information. The seller must also allow eight business
hours for the prescriber to respond. During the initial rulemaking in
2004, the Commission indicated that it would ``continue to monitor
whether full, valid requests for verification of a prescription are
being made through the use of automated telephone systems'' and may
revisit the issue ``[i]f evidence demonstrates that sellers are not
making valid verification requests but are providing consumers with
contact lenses despite deficient requests.'' \180\
---------------------------------------------------------------------------
\179\ When seeking verification of a prescription, the seller
must provide the prescriber with: The patient's full name and
address; the contact lens power, manufacturer, base curve or
appropriate designation, and diameter when appropriate; the quantity
of lenses ordered; the date of patient request; the date and time of
verification request; the name of a contact person at the seller's
company, including facsimile and telephone numbers; and, if the
seller is counting the prescriber's regular Saturday hours as
``business hours,'' a clear statement of the prescriber's regular
Saturday business hours. 16 CFR 315.5(b).
\180\ 69 FR at 40489.
---------------------------------------------------------------------------
The comments submitted in this Rule review by optometrists,
students of optometry, and their trade associations provide the
Commission with some evidence that some prescribers are receiving
incomplete or otherwise inadequate verification requests. In addition,
the Coalition for Patient Vision Care Safety asserted there is
substantial evidence that verification requests are deficient and the
American Optometric Association claimed that problems with 1-800
CONTACTS' automated verification systems are often reported by its
members.\181\ However, commenters did not provide any empirical data
regarding the frequency of these various practices, average or
aggregate costs associated with automated calls in particular, or the
number of illegal or otherwise deficient contact lens sales that result
from such calls. Furthermore, the Commission lacks evidence indicating
whether these problems occur with automated calls generally or are
chiefly associated with only one or a small group of sellers. If the
reported problems chiefly are associated with the practices or systems
of a limited number of sellers, the Commission would consider education
of, or enforcement against, such sellers, rather than an amendment to
the Rule at this time.\182\
---------------------------------------------------------------------------
\181\ Coalition for Patient Vision Care Safety (Comment #621);
American Optometric Association (Comment #644).
\182\ In fact, a number of state optometric associations note
that the costs prescribers' offices expend related to the Rule are
most often due to incomplete or otherwise inadequate verification
requests. Michigan Optometric Association (Comment #86); Wisconsin
Optometric Association (Comment #30); Pennsylvania Optometric
Association (Comment #46); Iowa Optometric Association (Comment
#79); New Mexico Optometric Association (Comment #211). Thus,
education and enforcement efforts to improve sellers' compliance
with the verification aspects of the Rule may have a large benefit
for prescribers, without the need to prohibit automated verification
calls.
---------------------------------------------------------------------------
Incomplete or incoherent verification requests are not valid
verification requests.\183\ However, a seller may not always realize
that it has made an invalid request and, hence, might dispense lenses
under an assumption of
[[Page 88541]]
passive verification if the prescriber does not contact the seller
within eight business hours of the invalid request. Accordingly, to
prevent the improper dispensing of lenses, the Commission encourages
prescribers to contact the seller in these circumstances to inform them
that the request is invalid and state the basis for the invalidity.
Once the prescriber communicates that the request is invalid and states
the basis for the invalidity, the seller shall not fill the order.
Alternatively, for incomplete requests, the Commission encourages
prescribers, to the extent they are able, to complete the missing
information in order to facilitate the dispensing of the contact
lenses.
---------------------------------------------------------------------------
\183\ 69 FR at 40496 (``The Commission emphasizes that the sale
of contact lenses based on a verification request which does not
contain all of the required information constitutes a Rule
violation.'').
---------------------------------------------------------------------------
The Commission is sensitive to the business concerns of the
prescribers who complain about the burden and inconvenience they
experience from the sellers' use of automated telephone systems.
However, the Commission has not seen convincing evidence that the
volume of automated verification calls they receive each day presents a
burden that is not outweighed by the competitive benefits of the Rule,
or that these practices frequently result in illegal sales of contact
lenses. If the Commission receives evidence of a compelling widespread
problem, it may revisit its position on the use of automated
verification requests.\184\ At this point, however, the Commission
declines to prohibit the use of automated verification calls.
---------------------------------------------------------------------------
\184\ The Commission notes that since Congress expressly
permitted telephone as a form of direct communication for
verification, if the Commission were to prohibit automated telephone
calls, more live communications might result. Such communications
would not necessarily alleviate all of the concerns expressed by
commenters and might cause more problems for sellers with a large
volume of orders and/or a small amount of staff.
---------------------------------------------------------------------------
Nevertheless, the Commission encourages sellers, to the extent
possible, to consider whether they could alleviate some of the
commenters' concerns by modifying their automated telephonic
verification procedures or, alternatively, by increasing the use of
other permissible communication methods. The Commission also seeks
additional information on possible modifications to the Rule that,
short of prohibiting automated verifications calls, could address the
issues raised by commenters relating to these calls.
The Commission declines to restrict when sellers may place
automated phone verification calls. As long as sellers are placing
valid and complete verification requests, and are not shipping orders
prior to active verification, or the passage of eight business hours,
automated telephone verification requests placed outside of a
prescriber's business hours comply with the Rule. Moreover, a review of
the comments reveals that some prescribers object to calls during
office hours, while others object to calls during evening and weekend
hours. The Commission therefore does not propose, at this time, to
limit the time period when sellers may place automated calls.
B. Section 315.5(b)--Information for Verification
Section 315.5(b) delineates the information required for a
prescription verification request: (1) Patient's full name and address;
(2) the contact lens power, manufacturer, base curve or appropriate
designation, and diameter when appropriate; (3) the quantity of lenses
ordered; (4) the date of patient request; (5) the date and time of
verification request; (6) the name of a contact person at the seller's
company, including facsimile and telephone numbers; and (7) if the
seller opts to include the prescriber's regular business hours on
Saturday as ``business hours'' for purposes of computing the eight
business hour calculation, a clear statement of the prescriber's
regular Saturday business hours.
1. Vendor Contact Information
A few individual prescribers stated that they were unable to
contact vendors in order to get additional information when the
verification request was incomplete.\185\ The American Optometric
Association also voiced concerns about the difficulty that prescribers
have in reaching an individual at 1-800 CONTACTS to discuss
prescription concerns.\186\ Several state optometric associations
asserted that physician small businesses may spend significant time on
hold or attempting to use various phone numbers or automated prompts to
reach a live person. These commenters recommended that the Commission
require larger contact lens retailers to make available more than one
individual at a company to act as the contact person for physician
questions and concerns.\187\ Commenters did not explain the nature of
the incomplete verification requests such that a live person was
necessary to address the inadequacy of the request, nor did they
elaborate upon the reasons why prescribers need to reach live persons
at contact lens retailers to answer ``questions and concerns.''
---------------------------------------------------------------------------
\185\ Truong (Comment #55); Cervantes (Comment #479).
\186\ Comment #644.
\187\ Virginia Optometric Association (Comment #16); Wisconsin
Optometric Association (Comment #30); Utah Optometric Association
(Comment #39); Pennsylvania Optometric Association (Comment #46);
Alabama Optometric Association (Comment #48); Iowa Optometric
Association (Comment #79); Michigan Optometric Association (Comment
#86); California Optometric Association (Comment #119); New Mexico
Optometric Association (Comment #211); Mississippi Optometric
Association (Comment #548); Ohio Optometric Association (Comment
#556); Connecticut Association of Optometrists (Comment #560); North
Carolina State Optometric Society (Comment #567); Tennessee
Association of Optometric Physicians (Comment #575); Colorado
Optometric Association (Comment #584); New Jersey Society of
Optometric Physicians (Comment #595).
---------------------------------------------------------------------------
The Commission declines to propose this Rule modification. The Rule
requires that the seller provide the name of a contact person at the
seller's company, including facsimile and telephone numbers.\188\ In
requiring a facsimile number as well as a telephone number, it is clear
that the Act and the Rule intended to provide for direct communication,
but not necessarily contemporaneous, live communication. The language
of the Act and the Rule anticipates that some sellers will communicate
with prescribers via live agents, but does not require it. Instead, the
Act and the Rule allow sellers also to communicate with prescribers
about verification requests via facsimile as well as voicemail.
---------------------------------------------------------------------------
\188\ 16 CFR 315.5(b)(6).
---------------------------------------------------------------------------
Furthermore, the Commission does not believe it is necessary to
require large contact lens retailers to have more than one individual
available for prescriber questions and concerns, as long as a contact
person is ``reasonably accessible to the prescriber.'' \189\ As
discussed in the initial rulemaking, the vendor contact provision is
intended to ensure that the prescriber is able to reach a responsible
person at the seller's company.\190\ No evidence was presented showing
how often prescribers experience difficulty in obtaining reasonable
access to a contact person at the seller's company.\191\ Without such
[[Page 88542]]
evidence, the Commission cannot determine whether a modification of the
Rule is necessary.
---------------------------------------------------------------------------
\189\ 69 FR at 40497.
\190\ Id. The Rule also requires that during the eight-business-
hour window, ``the seller shall provide a reasonable opportunity for
the prescriber to communicate with the seller concerning the
verification request.'' 16 CFR 315.5(c)(3). In the initial
rulemaking, the Commission declined to articulate with specificity
the equipment or personnel that sellers must have to handle
verification requests, in order to give sellers the flexibility to
determine the most effective and efficient means of providing the
opportunity to communicate. Rather, the Commission promulgated the
final Rule to require that sellers provide prescribers a
``reasonable opportunity'' for the prescriber to communicate with
the seller. 69 FR 40499.
\191\ Likewise, the Commission did not receive evidence
sufficient to show that the methods for communication offered by
sellers do not provide prescribers with a reasonable opportunity to
communicate with the seller about the verification request.
---------------------------------------------------------------------------
Moreover, as discussed earlier,\192\ if a verification request is
incomplete, the request is invalid. If the prescriber communicates to
the seller within the Rule-specified deadline that the verification
request or the prescription is invalid,\193\ the seller may not fill
the prescription.\194\ It is not necessary to reach a live person to
perform this function. Once alerted that a verification request is
invalid and the reason for the invalidity, the burden falls on the
seller to resolve the invalidity, if possible. In addition, in routine
cases it would not be necessary to reach a live person in order to
correct a prescription. Accordingly, the rulemaking record contains
insufficient evidence to show that mandating a mechanism for
contemporaneous live communications is necessary to carry out the Act.
---------------------------------------------------------------------------
\192\ See supra Section IV.A.3.
\193\ If a prescriber deems a prescription invalid, the Rule
requires that the prescriber specify the basis for the invalidity.
16 CFR 315.5(d).
\194\ In addition, Warby Parker proposed that the Commission
include stronger language in the Rule to make clear that it is a
violation for prescribers to respond to a verification request by
stating that prescription information is incorrect when, in fact, it
is not; or to respond to a verification request by stating that
prescription information is inaccurate or invalid without providing
the basis for the inaccuracy or invalidity of the prescription.
Comment #593. The Rule already provides that if a prescriber
indicates that a prescription is inaccurate or invalid, the
prescriber shall specify the basis for doing so. A failure to do so
violates the Rule. See 16 CFR 315.5(d). Further, falsely indicating
that a prescription was inaccurate would essentially equal a failure
to ``correct'' a prescription, as mandated by the Rule and
therefore, also would be a violation. See id. The Commission does
not believe it needs to clarify these prescriber obligations
further. Warby Parker also proposed that the Commission clarify that
it is a violation of the Rule for a prescriber to interfere, in any
way, with a seller's effort to verify a prescription. This proposal
is not described in detail nor is the frequency of this problem
supported with empirical evidence. The Commission therefore declines
to propose this Rule modification.
---------------------------------------------------------------------------
The American Optometric Association also urged the Commission to
amend the Rule to require sellers to respond to prescriber questions
within an eight-business-hour window, or cancel the sale without
verification. The Association's comment did not explain the types of
concerns that prescribers need to discuss with live agents at contact
lens retailers. This proposal would require that once a prescriber
contacted a seller with concerns, the seller could not assume the
prescription was verified. Instead, the seller would be required to
personally contact the prescriber and discuss the concerns within eight
business hours, or cancel the sale.\195\
---------------------------------------------------------------------------
\195\ Comment #644.
---------------------------------------------------------------------------
The Commission declines to propose this modification as well. As
discussed above, neither the Act nor the Rule requires contemporaneous,
live communication between prescribers and sellers. Furthermore, the
Commission believes that such a requirement would undercut the Act's
passive verification framework. Such a mechanism could conceivably
allow any prescriber to lodge a concern or question and thereby halt
the passive verification mechanism. As discussed above, if the
prescription verification request is incomplete or inaccurate, or if
the prescription is expired or otherwise invalid, the prescriber may
alert the seller. The seller cannot fill a prescription if the
prescriber has indicated that the prescription is expired or otherwise
invalid.
2. Prescribers' Selection of Communication Mechanism
A few commenters suggested that the prescriber should have the
ability to choose the method of communication sellers use to
communicate verification requests with their offices.\196\ One
commenter stated that she requested a seller make all future
verification requests through facsimile, but the seller, who sometimes
made requests via facsimile, refused her request.\197\ A number of
prescribers expressed a preference for sellers to use another type of
communication to verify contact lens prescriptions, including facsimile
or email.\198\ A few prescribers requested that sellers use live
telephone calls to communicate with their offices.\199\ The concept of
having prescribers select the communication method that the seller
would use to verify a prescription (i.e. by telephone, fax, or online)
was previously raised with the Commission during the initial
rulemaking.\200\ As the Commission then determined, because the Act
defines ``direct communication'' to include three different
communication mechanisms that sellers may use--telephone, facsimile or
electronic mail--the Act does not permit prescribers to limit the
communication mechanisms sellers may use to submit verification
requests.\201\ Nevertheless, nothing prevents a seller from honoring a
prescriber's request for a certain type of communication and the
Commission suggests that sellers evaluate whether honoring such
requests would increase the speed and efficiency of the verification
process.
---------------------------------------------------------------------------
\196\ Filandro (Comment #129); Chakuroff (Comment #189); Stuart
(Comment #635).
\197\ Chakuroff (Comment #189).
\198\ Mirkin (Comment #111) (stating that fax or email
verifications are quick and easy to answer); Chang (Comment # 126)
(requesting fax or email verification system); Filandro (Comment
#129) (requesting sellers offer all offices fax option for
verification requests); Koch (requesting use of fax); Rubow (Comment
#649) (seeking a requirement that online retailers verify through a
route that is intelligible, including fax or a live person). But see
Hicks (Comment #256) (stating automated fax systems are difficult
for their offices as the fax machine is in an area of the business
that is not frequently used); Ambler (Comment #524) (complaining of
receipt of poor quality faxes when the office is closed).
\199\ Mirkin (Comment #111); Hicks (Comment #256) (stating a
simple, quick phone call is much easier and would result in faster
turnaround times for the patients); Rubow (Comment #649).
\200\ 69 FR at 40497.
\201\ See 15 U.S.C. 7603(g).
---------------------------------------------------------------------------
C. Section 315.5(c)--Verification Events
Section 315.5(c) sets forth the three circumstances under which a
seller can consider a prescription ``verified by direct communication''
and proceed to sell contact lenses to its customer: (1) The prescriber
confirms the prescription is accurate by direct communication with the
seller; (2) the prescriber informs the seller through direct
communication that the prescription is inaccurate and provides the
accurate prescription; and (3) the prescriber fails to communicate with
the seller within eight business hours after receiving a proper
verification request from the seller.\202\
---------------------------------------------------------------------------
\202\ 16 CFR 315.5(c).
---------------------------------------------------------------------------
1. Passive Verification
A number of commenters expressed the view that because contact
lenses are restricted medical devices, they should not be dispensed
unless the prescriber actively verifies the prescription.\203\ The
Contact Lens Association of Ophthalmologists, for example, in arguing
for the elimination of passive verification, stated that it ``puts the
health of consumers at risk and is inconsistent with regulatory
practices for confirmation of the validity and accuracy of
prescriptions for drugs and for other Class II and Class Ill medical
devices.'' \204\
---------------------------------------------------------------------------
\203\ California Optometric Association (Comment #119)
(``Contact lenses are medical devices. Therefore, it is reasonable
to replace passive verification with active verification for contact
lenses.''); Weissman (Comment #50) (same); Bainbridge (Comment #152)
(``Start treating contact lenses like the medical devices they are
and start respecting the clinical judgment of doctors.'').
\204\ Comment #572.
---------------------------------------------------------------------------
Other commenters expressed the concern that the passive
verification framework can be manipulated and, therefore, does not
adequately ensure that patients receive contact lenses in accordance
with proper medical
[[Page 88543]]
oversight. For example, some commenters asserted that passive
verification is problematic because patients, in some circumstances,
may be able to obtain lenses by providing fictional or incorrect
information to sellers.\205\ A common scenario relayed by commenters is
that if the patient provides the seller with the name of a fictional
prescriber and a fictional fax number, the prescription will be
passively verified when there is no response within eight hours.\206\
---------------------------------------------------------------------------
\205\ Wang (Comment #94) (discussing ``deliberate attempts to
evade verification with the knowledge that a lack of verification is
equivalent to a prescription being verified''); Anklin (Comment
#107) (describing the use of incorrect or even falsified
information); Filandro (Comment #129) (noting that patients can fax
the request to their own home or email); Stewart (Comment #136)
(patients are able to use any fax number); McCutchan (Comment #624)
(describing use of fax numbers for practices that are no longer
active).
\206\ Caughell (Comment #7); Truong (Comment #55); Navarro
(Comment #117); Zierlein (Comment #123); Ammon (Comment #128);
Ciszek (Comment #134); Lee (Comment #158); Ambrose (Comment #196);
Ahmed (Comment #209); Dell (Comment #227); Williston (Comment #252);
Pentecost (Comment #268); Smith (Comment #319); Makler (Comment
#356); Bolenbaker (Comment #357); McWilliams (Comment #362); Diaz
(Comment #380); Liebig (Comment #478); Balitski (Comment #485);
Garcia (Comment #511); Loerzel (Comment #550); Pham (Comment #641);
Lisenby (Comment #662).
---------------------------------------------------------------------------
Some prescribers reported instances where some patients were never
seen by a prescriber, and apparently the consumer just pulled the
prescriber information from a Web site in an attempt to get a
prescription verified via passive verification.\207\ A few commenters
reported that patients said they were instructed--by sellers--to use
any optometrist name, or any facsimile number, in order to facilitate
the order.\208\ A few commenters also complained that after they have
flagged a verification request as invalid, some sellers try to game the
system and trigger a passive verification by then repeatedly faxing the
same verification request to the prescriber in the hopes that the
prescriber will not have the opportunity to deny the verification
request again, and it will end up passively verified.\209\
---------------------------------------------------------------------------
\207\ Driesen (Comment #47); Howe (Comment #53); Cherian
(Comment #89); Hosaka (Comment #240); Chavez (Comment #334); Ling
(Comment #390); Redder (Comment #454); Nakasone (Comment #469); Ball
(Comment #590); Heuer (Comment #467); Ostrom (Comment #489); Hartman
(Comment #522); Milsky (Comment #559).
\208\ Sadeghian (Comment #242) (``A number of patients tell me
that it is common practice by these online contact lens companies to
tell the consumer to leave [the consumer's] fax number as the
doctor's fax so nobody would respond to their requests.'');
Alianiello (Comment #253) (``I asked where he's been buying contact
lenses and he told me the online avenue he uses asked him for his
doctor's name, and when he told them he couldn't spell my last name
they told him to look in the phone book and give them a name of an
optometrist and they'd take care of it.'').
\209\ See, e.g., Christensen (Comment #149).
---------------------------------------------------------------------------
In light of these concerns, some commenters concluded that the
passive verification system is not working as intended to protect
patient eye health and instead, recommended that all contact lens
prescriptions be actively verified.\210\ One commenter recommended that
the Rule be modified to prevent the shipping of contact lenses without
active verification.\211\ Another commenter said that if the retailer
has not received an image of the actual prescription, the seller should
at least obtain some confirmation that the customer is genuinely a
patient of the prescriber that is being contacted for
verification.\212\
---------------------------------------------------------------------------
\210\ Driscoll (Comment #67); Diaz (Comment #380); Whittington
(Comment #443).
\211\ Palmer (Comment #484).
\212\ Milsky (Comment #559). This commenter also proposed that
in order to allow eye doctors and the Commission to be able to track
in detail what happens to online orders after the verification
request is sent, the seller should be required to inform the
prescriber whether the transaction was cancelled or completed, and
if so, what exactly was shipped and when. This mechanism would
document whether lenses were shipped before any verification took
place.
---------------------------------------------------------------------------
The Commission declines to propose these Rule modifications. Issues
identical to these were raised during the initial rulemaking process in
2004, when commenters either opposed or expressed significant concern
about the passive verification system imposed by the Act and the
Rule.\213\ At that time, some commenters were concerned about the use
of a passive verification system for prescription medical devices such
as contact lenses. Other commenters, during the initial rulemaking,
expressed concern that verification requests could be sent to the wrong
prescriber and might be improperly filled via passive verification
because the prescriber neglected to respond to it.\214\
---------------------------------------------------------------------------
\213\ 69 FR at 40497 and note 206.
\214\ 69 FR at 40497 and note 198.
---------------------------------------------------------------------------
The Commission responded to concerns about passive verification by
finding that ``[b]ecause Congress has decided to impose a passive
verification system through the Act, whether to adopt a passive
verification system is not at issue in this rulemaking proceeding.''
\215\ The same holds true today, and this rule review does not revisit
the decision to include a passive verification system.
---------------------------------------------------------------------------
\215\ 69 FR at 40497.
---------------------------------------------------------------------------
With respect to concerns that patients are manipulating the passive
verification system by deliberately providing inaccurate prescriber
information, the Commission notes that if prescribers receive
verification requests for individuals who are not their patients,
prescribers have the ability and incentive to respond that such
requests are ``invalid'' under section 315.5(d) of the Rule,\216\ thus
preventing an improper passive verification.
---------------------------------------------------------------------------
\216\ Id.
---------------------------------------------------------------------------
With regard to concerns that patients are deliberately providing
fictional prescriber information and fictional contact information,
commenters produced only anecdotal evidence of such actions, and did
not provide empirical data regarding the frequency of these activities.
Although it is possible that such activities could allow some patients
to obtain contact lenses without a valid prescription, the Commission
notes that in doing so, such individuals are intentionally
circumventing the Rule. As discussed above, the passive verification
framework has been mandated by Congress in an effort to balance the
interests of consumer health and prescription portability. At the time
the Act was under consideration, Congress was aware--after being
informed by the Commission and the American Optometric Association,
among others--that passive verification was not a foolproof method for
preventing the verification of invalid prescriptions.\217\ The
Commission will consider consumer education efforts designed to
encourage consumers to act responsibly,
[[Page 88544]]
within the confines of the Rule. In addition, to the extent that the
Commission receives evidence that sellers are encouraging consumers to
provide inaccurate or fictional prescriber information, the Commission
will investigate such allegations, as appropriate.
---------------------------------------------------------------------------
\217\ See, e.g., ``Fairness to Contact Lens Consumers Act:
Hearing Before the Subcommittee on Commerce, Trade, and Consumer
Protection of the House Committee on Energy and Commerce,'' 108th
Cong. 1 (Sept. 12, 2003) (Testimony of J. Pat Cummings, American
Optometric Association) (testifying that ``the problem with passive
verification'' is that some people will be able to get contact
lenses without a prescription); id. (Testimony of Howard J. Beales,
Federal Trade Commission) (noting that passive verification contains
a risk that some contact lenses will be provided based on out-of-
date prescriptions). Congress opted for passive verification after
hearing repeated reports of the difficulties consumers confronted
having prescriptions verified in states with active verification
systems. See H.R. Report No. 108-318, at 5 (2003) (stating the
Fairness to Contact Lens Consumers Act ``adopts a passive
verification system in order to best serve the consumer,'' after
hearing testimony from consumers and businesses of the ``unusually
high number of consumer complaints in states that rely on active
verification schemes.''). See also ``Fairness to Contact Lens
Consumers Act: Hearing Before the Subcommittee on Commerce, Trade,
and Consumer Protection of the House Committee on Energy and
Commerce,'' 108th Cong. 1 (Sept. 12, 2003) (Testimony of Peggy
Venable, Texas Citizens for a Sound Economy) (testifying that under
an active verification system in Texas, there was a ``widespread
practice [by optometrists] of failing to verify the prescription'');
id. (Testimony of Jonathan C. Coon, 1-800 CONTACTS) (testifying that
under active verification, 1-800 CONTACTS had to cancel half of all
orders in Texas due to prescribers' failure to respond to
verification requests).
---------------------------------------------------------------------------
#2. Issues Regarding the Eight-Business-Hour Window
Some commenters stated that the current eight-business-hour window
is a reasonable length of time for prescribers to respond to
verification requests.\218\ 1-800 CONTACTS, for example, asserted that
the ``eight business-hour time frame for passive verification gives
prescribers sufficient time to confirm important health information and
correct any inaccurate orders without imposing a needless delay on
consumers who place a premium on quick delivery.'' \219\ As support, 1-
800 CONTACTS stated that last year it cancelled orders worth
approximately $40 million in response to communications from
prescribers, and that the ``number of deleted orders and the value of
sales cancelled demonstrate that prescribers have more than adequate
time to respond when necessary.'' \220\
---------------------------------------------------------------------------
\218\ 1-800 CONTACTS (Comment #568). See also Warby Parker
(Comment #593) (``Passive verification provides prescribers with a
reasonable opportunity to verify, address or correct an inaccurate,
invalid or expired prescription without imposing an undue burden on
the prescriber. Furthermore, it gives the seller a reasonable end-
point at which to proceed with the sale. This ensures that
prescribers do not thwart patient choice of where to purchase
contact lenses by failing to verify a prescription and relegating
the patient back to the prescriber for the ultimate purchase. We
also believe that eight business hours is a reasonable length of
time for passive verification.'').
\219\ Comment #568.
\220\ Id.
---------------------------------------------------------------------------
Other commenters, however, argued that the eight-business-hour time
frame for passive verification does not allow enough time for doctors
to notify sellers that a prescription is expired, inaccurate, or
nonexistent. The American Academy of Ophthalmology, for example, stated
that the eight-business-hour requirement ``is far too short and
ultimately imposes significant burdens on providers and in many
instances eliminates a necessary patient safety check.'' \221\ Some
prescribers noted that their offices are very busy and that eight
business hours was not enough time to verify prescriptions.\222\ The
CLAO suggested that eight business hours was insufficient because
``validation requests arrive with incomplete or erroneous patient
information complicating the process by which clinical records are
retrieved.'' \223\ These comments, however, did not quantify how the
eight-business-hour time frame imposed ``significant burdens'' on
providers, nor establish that a significant number of prescribers were
unable to respond to verification requests within eight business hours.
Commenters similarly failed to provide specific information quantifying
the frequency of incomplete or incorrect validation requests.
---------------------------------------------------------------------------
\221\ Comment #611.
\222\ Tran (Comment #260); Bierwerth (Comment #308); Loerzel
(Comment #550); Fink-Freeman (Comment #609).
\223\ CLAO (Comment #572).
---------------------------------------------------------------------------
Many commenters did not propose a specific extension of time to
respond to a verification request,\224\ and merely stated that eight
business hours was not enough. Some commenters did put forth specific
proposals, such as changing the language to ``eight (8) business hours
or twenty-four (24) clock hours, whichever is later,'' \225\ doubling
the length of time to 16 hours,\226\ or extending the verification
window to at least two business days.\227\ Others suggested providing
at least 48 to 72 hours,\228\ or two to three business days,\229\ to
confirm the validity of a prescription. A few commenters suggested that
increasing the window to 72 hours would alleviate issues that arise
when verifications are received on Friday, Saturday or Sunday.\230\
---------------------------------------------------------------------------
\224\ Whittington (Comment #443) (``more than eight hours to
confirm the RX request''); Heuer (Comment #467) (``reasonable amount
of time to respond'').
\225\ Milsky (Comment #559) (``That change would still not
prevent the situation where, for example, a verification request
comes in on a holiday weekend and the prescriber's office is closed
for an extra day off, or when a practice is not open on Wednesdays,
but at least it would mean that the prescriber would have a little
more of an opportunity (especially at the beginning or end of the
workday) to correct any errors in the verification request, before
the order is shipped and it's too late.'').
\226\ Kiener (Comment #74); Perala (Comment #315); Diaz (Comment
#380).
\227\ CLAO (Comment #572); Koury (Comment #573); Fink-Freeman
(Comment #609); American Academy of Ophthalmology (Comment #611).
See also Hua (Comment #45) (recommending an increase to 24 to 48
hours); Bhadra (Comment #105) (same).
\228\ Gooderman (Comment #10); Galdamex (Comment #167) (at least
72 hours); Lin-Dilorinzo (Comment #476); Espy (Comment #587).
\229\ Voight (Comment #551); Figazolo (Comment #24) (three
days); Truong (Comment #55) (three days).
\230\ Yaklich (Comment #364); Raff (Comment #373). See also
Coalition for Patient Vision Safety (Comment #621).
---------------------------------------------------------------------------
Having considered these comments, the Commission declines to
propose a Rule modification lengthening the eight-business-hour
timeframe during which a prescriber must respond to a verification
request. Despite comments that the timeframe is too short, the
Commission believes that the current eight-business-hour time frame is
adequate for the vast majority of prescribers. Commenters put forth no
empirical evidence that prescriptions are being improperly verified via
passive verification due to prescribers not having enough time to
respond, and cited no compelling changes in the marketplace that would
justify extending the time frame beyond eight business hours. If
anything, because of advances in technology, electronic communications,
and record-keeping, eight business hours is as appropriate, if not more
so, than when implemented in 2004. As the Commission explained in the
initial rulemaking, ``Congress recognized that consumers may be harmed
if they face undue delays in receiving their contact lenses from a
seller'' and balanced that consideration against the possible harm
consumers may experience if sellers provide contact lenses based on
invalid prescriptions.\231\ The Commission has found nothing thus far
in the record for this rule review proceeding to disturb that
determination.
---------------------------------------------------------------------------
\231\ 69 FR at 40482.
---------------------------------------------------------------------------
In addition to concerns about the time prescribers have to respond,
some commenters expressed concern about when verification calls are
placed and received. Some optometrists expressed concern that some
sellers are exploiting the Rule by placing verification requests after
hours in order to circumvent the eight-business-hour window.\232\ Other
prescribers noted with frustration that sellers fax verification
requests outside of normal business hours, such as in the middle of the
night or on weekends, thereby making it impossible for them to respond
in a timely fashion.\233\ Some commenters complained that because they
only had 24 hours to respond to a
[[Page 88545]]
verification request,\234\ such verifications would be confirmed
automatically over the weekend because no one was in the office.\235\
Other commenters noted that they receive verification faxes outside of
normal business hours and therefore have no way of verifying, denying,
or correcting prescriptions.\236\ Many of these commenters recommended
that the Rule be amended to prohibit sellers from sending prescription
verifications after business hours and on weekends.\237\ Along the same
lines, the Coalition for Patient Vision Safety recommended that the
Commission modify ``the eight-hours of communication when the initial
communication begins prior to a holiday or on a weekend when the doctor
is not conducting normal office hours.'' \238\
---------------------------------------------------------------------------
\232\ Berger (Comment #200) (``[u]nder the current law,
retailers are allowed to fill a prescription if verification is not
received within 8 hours. This is commonly exploited by faxing or
robodialing verification requests outside of normal business hours,
then filling the prescription before the prescriber responds.'').
See also Stahl (Comment #19); Lum (Comment #21); Peterson (Comment
#22); Maanum (Comment #23); Matthews (Comment #25); Borsky (Comment
#26); Hodes (Comment #42); Dodge (Comment #44); McBride (Comment
#171); Sloan (Comment #177); Kirkconnell (Comment #202); Hamilton
(Comment #216); Leach (Comment #257); Chang (Comment #258); Yaklich
(Comment #364); Leung (Comment #607); Wu (Comment #608); Vidulich
(Comment #612); Lai (Comment #620); Pechko (Comment #628); Liu
(Comment #656); Louie (Comment #657); Fong (Comment #669); Vo
(Comment #673).
\233\ Plumb (Comment #219); St. Martin (Comment #292); Diaz
(Comment #380); Witmeyer (Comment #418); Nakasone (Comment #469);
Garcia (Comment #511); Egbert (Comment #515); Steinleitner (Comment
#517).
\234\ Whipple (Comment #15); Huang (Comment #17); Wilson
(Comment #76); Green (Comment #162); Frederick (Comment #207); Zair
(Comment #512).
\235\ Magee (Comment #95); Mueller (Comment #513); Born (Comment
#570); Shugarman (Comment #266).
\236\ Glavine (Comment #62); Tolchin (Comment #194); Bricker
(Comment #195); Ahn (Comment #215); Lester (Comment #231); Kegarise
(Comment #447).
\237\ California Optometric Association (Comment #119); Stahl
(Comment #19); Lum (Comment #21); Peterson (Comment #22); Maanum
(Comment #23); Matthews (Comment #25); Borsky (Comment #26); Chriqui
(Comment #31); Hodes (Comment #42); Dodge (Comment #44); Loydall
(Comment #225); Leach (Comment #257); Chang (Comment #258); Liebig
(Comment #478); Harris (Comment #490); Leung (Comment #607); Wu
(Comment #608); Vidulich (Comment #612); Lai (Comment #620); Pechko
(Comment #628); Liu (Comment #656); Louie (Comment #657); Fong
(Comment #669); Vo (Comment #673).
\238\ Comment #621. Similarly, some commenters suggested
increasing the eight-business-hour window because, based on their
apparent misunderstanding of how the eight business hours are
calculated, they believed that they did not have enough time to
respond to verification requests received after business hours and
on weekends. See Mirkin (Comment #111); Kalman (Comment #150);
Bender (Comment #164); Hans (Comment #168); Baur (Comment #170;
Yaklich (Comment #364); Raff (Comment #373); Diaz (Comment #380);
Kegarise (Comment #447); Heuer (Comment #467); Zair (Comment #512);
Gandhi (Comment #588).
---------------------------------------------------------------------------
At this time, the Commission does not propose to amend the Rule to
prohibit sellers from sending prescription verification requests after
business hours and on weekends or to otherwise extend the eight-
business-hour window to account for weekends and holidays. It appears
that the majority of commenters suggesting this prohibition are
concerned that they do not have the opportunity to verify a
prescription because they believe the eight-business-hour window for
verification of a contact lens order is triggered upon receipt of a
verification request, no matter when that request is received. That
concern is misplaced. Section 315.2 of the Rule provides that ``[f]or
verification requests received by a prescriber during nonbusiness
hours, the calculation of `eight (8) business hours' shall begin at 9
a.m. on the next weekday that is not a Federal holiday or, if
applicable, on Saturday at the beginning of the prescriber's actual
business hours.'' \239\
---------------------------------------------------------------------------
\239\ See also 69 FR at 40486.
---------------------------------------------------------------------------
Other commenters expressed frustration that verification requests
were sent after regular business hours with the statement that the
prescription would be filled unless the prescriber contacted the seller
within 12 to 24 hours.\240\ Depending upon when these requests are
sent, these sellers' practices could result in contact lenses being
shipped before or after the end of the eight-business-hour window. To
the extent that sellers are dispensing contact lenses prior to the end
of the eight-business-hour window, the Commission notes that this
practice violates the Rule. If the Commission receives evidence that
sellers are dispensing contact lenses before the end of the eight-
business-hour window, the Commission will investigate such allegations,
as appropriate.
---------------------------------------------------------------------------
\240\ Huang (Comment #17); Magee (Comment #95); Green (Comment
#162); Shugarman (Comment #266).
---------------------------------------------------------------------------
A few commenters expressed concern that some prescriptions were
being automatically filled without a prescriber's oversight because the
calculation of an eight-business-hour window does not take into
consideration the fact that their offices may not be open or able to
verify prescriptions during the Rule's established timeframe for
business hours.\241\ For example, an office may be closed due to
vacation, inclement weather, or regularly scheduled office closures
that occur during the normal workweek.\242\
---------------------------------------------------------------------------
\241\ A small number of commenters complained that they
regularly received verification requests from sellers that state
that their records indicate that the prescriber has Saturday
business hours. See Alianiello (Comment #253); Raff (Comment #373).
These commenters said that despite correcting this misimpression,
the seller continued to send verification requests that would begin
the eight-business-hour window on Saturday morning. The Commission
reiterates that this is a Rule violation because the seller only may
count Saturday hours as business hours if the seller has actual
knowledge of the prescriber's Saturday business hours. Here, the
seller has actual knowledge to the contrary. 69 FR at 40485. If the
Commission receives evidence of such practices, the Commission will
investigate such allegations, as appropriate.
\242\ Robins (Comment #165); Glassband (Comment #218); Kubo
(Comment #234); Whang (Comment #355); Makler (Comment #356); Falcon
(Comment #505); Manuel (Comment #508); Voight (Comment #551); Koury
(Comment #573); Kowaleski (Comment #578).
---------------------------------------------------------------------------
Similar concerns were raised by commenters in the initial
rulemaking in 2004. At that time, the Commission declined to adopt an
actual hours or other prescriber-specific approach to business hours,
noting that ``[i]t likely would be difficult and burdensome--perhaps
impossible--for some sellers to determine and keep track of the actual
hours of 50,000 prescribers. By contrast, a general rule using a
uniform definition of business hours for all prescribers provides
clarity and relative ease of compliance and enforcement.'' \243\ In
addition, the Commission recognized that there ``does not appear to be
any practical way to accommodate the myriad circumstances during which
the offices of 50,000 individual prescribers may be closed or otherwise
not able to respond to a prescription verification request.'' \244\ The
Commission continues to believe that such an approach would be
impractical and declines to propose an actual hours or other
prescriber-specific approach to calculating business hours.
---------------------------------------------------------------------------
\243\ 69 FR at 40484.
\244\ Id.
---------------------------------------------------------------------------
V. Contact Lens Prescriptions
A. Section 315.6--Expiration of Contact Lens Prescriptions
As set forth by Section 315.6(a) of the Rule, a contact lens
prescription expires on the date specified by the law of the State in
which the prescription was written, if that date is one year or more
after the issue date of the prescription.\245\ If State law specifies
no date or specifies a date less than one year after the issue date of
the prescription, the Rule provides that the prescription shall not
expire less than one year after the issue date of the
prescription.\246\ A prescriber, nonetheless, can specify a shorter
expiration date if that date is ``based on the medical judgment of the
prescriber with respect to the ocular health of the patient.'' \247\
The prescriber then must document the reasons in the patient's medical
record.\248\ In other words, contact lens prescriptions cannot expire
in less than one year unless, based on medical judgment, a prescriber
specifies a different date and documents the
[[Page 88546]]
reasoning. The language of these Rule provisions closely tracks that of
the Act.\249\
---------------------------------------------------------------------------
\245\ 16 CFR 315.6(a)(1). The majority of states require that a
contact lens prescription not expire less than one year after the
issue date, except when a special medical circumstance necessitates
that it expire sooner. A few states, such as Maryland and
Washington, require that contact lens prescriptions not expire less
than two years after the issue date except for special medical
circumstances. See, e.g., Maryland Code Sec. 11-404.4; Wash. Admin.
Code Sec. 246-852-010 (1)(f).
\246\ 16 CFR 315.6(a)(2).
\247\ 16 CFR 315.6(a)(3).
\248\ 16 CFR 315.6(b)(1).
\249\ 15 U.S.C. 7604.
---------------------------------------------------------------------------
1. Length of Contact Lens Prescriptions
The Commission received several comments about the length of
contact lens prescriptions. Some commenters expressed the view that the
prescription length should be longer. For example, Consumers Union
requested that the Commission ``consider whether a longer minimum
period is warranted in the best interests of the consumer.'' \250\ One
consumer commented that contact lens prescriptions should be at least
two years in length.\251\
---------------------------------------------------------------------------
\250\ Comment #677.
\251\ Schodowski (Comment #65).
---------------------------------------------------------------------------
The Professional Opticians of Florida recommended that the
Commission modify the Rule to prohibit the use of expiration dates on
prescriptions for adult patients with low risk factors,\252\ while an
optometrist argued that, ``[c]ompetition for the sales of contact
lenses is so great that placing any regulations on the length of the
prescription is unnecessary and should be at the sole discretion of the
prescriber.'' \253\ LD Vision Group, a contact lens retailer, declared
that while it generally makes sense for patients to undergo a
comprehensive eye examination to ensure good eye health, patients
should not have to undergo a follow-up contact lens fitting after
receiving a trial pair of contact lenses from a prescriber.\254\
Furthermore, according to that commenter, patients should be able to
waive the requirement that their contact lens prescriptions be
verified--and yet still be able to obtain contact lenses--by
acknowledging that they are aware of the risks of not obtaining an
annual eye examination.\255\
---------------------------------------------------------------------------
\252\ Comment #563.
\253\ Bolenbaker (Comment #357).
\254\ LD Vision Group (Comment #544).
\255\ Id.
---------------------------------------------------------------------------
However, many commenters, primarily prescribers, urged the
Commission not to ``deregulate'' prescription length \256\ or otherwise
extend the length of contact lens prescriptions.\257\ Other prescribers
encouraged the Commission to retain the one-year prescription length,
citing the importance of annual eye examinations for preventing
complications related to contact lens use, diagnosing other conditions
by examining the eyes, and providing patient education about contact
lens use.\258\ A few commenters expressed satisfaction with the two-
year prescription length imposed by some States' laws.\259\
---------------------------------------------------------------------------
\256\ Wood (Comment #37); Compton (Comment #275); Singhai
(Comment #281).
\257\ See, e.g., Morgan (Comment #144); Stoliker (Comment #286);
Parikh (Comment #288); Shlosman (Comment #290); Lee (Comment #293);
Paulsen (Comment #296); Turano (Comment #303); Yang (Comment #307);
Daniel (Comment #310); Huynh (Comment #313); Stetson (Comment #314);
Theroux (Comment #317); Wong (Comment #330); Tarr (Comment #344);
Peres-Maes (Comment #346); Dronka (Comment #347);Scott (Comment
#354); Cantor (Comment #358); Cesar (Comment #359); Philippe
(Comment #365); Geller (Comment #370); Uchida (Comment #403); Sharma
(Comment #404): Nguyen (Comment #412); Eng (Comment #414); Frady
(Comment #440); Santhanam (Comment#444); Calhoun (Comment #446);
Howard (Comment #453); Desai (Comment #462); Douglas (Comment #526);
Geiger (Comment #598); Ancona (Comment #650); Webster (Comment
#670).
\258\ See, e.g., Coalition for Patient Vision Care Safety
(Comment #621);Williford (Comment #38); Kapoor (Comment #58);
Anderson (Comment #96); Tse (Comment #146); Morrison (Comment #239);
Major (Comment #263); Uy (Comment #277); Williams (Comment #261);
Walker (Comment #283); Murray (Comment #287); Rice (Comment #295);
Harris (Comment #305); Cluff (Comment #309); Hollister (Comment
#318); Oliver (Comment #323); Gelman (Comment #326); Cox (Comment
#336); Zimmerman (Comment #372); Sherman (Comment #375); Klein
(Comment #377); Hafford (Comment #383); Blankenship (Comment #395);
Elmore (Comment #396); Assell (Comment #397); Yaryan (Comment #401);
Stefanovic (Comment #417); Enochs (Comment #423); Moore (Comment
#437); Archibald (Comment #438); Lott (Comment #445); Goller
(Comment #448); Eggers (Comment #473); Abbott (Comment #497);
Nazario (Comment #518); Neuenfeldt (Comment #542); Maino (Comment
#555); Bieter (Comment #602); Lac (Comment #631); Bandy (Comment
#643); Lee (Comment #659); Alexander (Comment #666).
\259\ Hua (Comment #45); Campbell (Comment #348).
---------------------------------------------------------------------------
The Commission declines to propose any changes--either removing or
lengthening--the Rule's prescription length provisions. As indicated
above, the Rule's language closely tracks that of the Act, which set a
minimum expiration date ``to prevent prescribers from selecting a short
expiration date for a prescription that unduly limits the ability of
consumers to purchase contact lenses from other sellers, unless medical
reasons justify setting such an expiration date.'' \260\ Accordingly,
the Commission is not at liberty to remove the prescription expiration
provision. In addition, the Commission declines to propose to lengthen
the Rule's prescription expiration provisions and believes the current
framework is appropriate. As the Commission concluded in response to
commenters arguing for a minimum expiration date of two years during
the initial rulemaking, in drafting the Act, Congress intended to defer
to applicable State law except where such law establishes an expiration
period of less than one year.\261\
---------------------------------------------------------------------------
\260\ 69 FR at 40504; 69 FR at 5443.
\261\ 69 FR at 40504.
---------------------------------------------------------------------------
2. Expired Contact Lens Prescriptions
A number of prescribers reported that some of their patients are
obtaining contact lenses through online vendors even though their
contact lens prescriptions have expired.\262\ According to Johnson &
Johnson Vision Care, Inc., ``roughly one-in-three online contact lens
purchasers'' surveyed in a 2015 APCO Insight online survey ``admit[ted]
to ordering lenses using an already expired prescription.'' \263\ In
response to these concerns, some commenters recommended that the
Commission amend the Rule specifically to prohibit the sale of contact
lenses to patients with expired prescriptions.\264\
---------------------------------------------------------------------------
\262\ See, e.g., Williford (Comment #38); Glavine (Comment #62);
Jones (Comment #63); Copeland (Comment #73); Weinberg (Comment #87);
Moody (Comment #92); Buthod (Comment #81); Kreda (Comment #93);
Magee (Comment #95); Voreis (Comment #114); Navarro (Comment #117);
Taylor (Comment #120); Dyak (Comment #124); Stewart (Comment #136);
Madden (Comment #155); Robertson (Comment #180); Chakuroff (Comment
#189); Law (Comment #190); Burruss (Comment #192); Bricker (Comment
#195); Stephens (Comment #210); Sadeghian (Comment #242); Pentecost
(Comment #268); Shaw (Comment #339); Chea (Comment #352);
Steinleitner (Comment #517); Holler (Comment #553); Song (Comment
#654).
\263\ Comment #582 (emphasis deleted). The survey, conducted on
behalf of Johnson & Johnson Vision Care, Inc. included 500 contact
lens users 18 years of age or older who had purchased contacts
online in the prior six months. See also Coalition for Patient
Vision Care Safety (Comment #621) (referencing 2015 APCO Insight
Survey).
\264\ Stahl (Comment #19); Lum (Comment #21); Peterson (Comment
#22); Maanum (Comment #23); Matthews (Comment #25); Borsky (Comment
#26); Chriqui (Comment #31); Hodes (Comment #42); Dodge (Comment
#44); Ellingson (Comment #66); Leach (Comment #257); Chang (Comment
#258); Leung (Comment #607); Wu (Comment #608); Vidulich (Comment
#612); Lai (Comment #620); Pechko (Comment #628); Liu (Comment
#656); Louie (Comment #657); Fong (Comment #669); Vo (Comment #673).
---------------------------------------------------------------------------
After reviewing the comments, the Commission has determined that no
amendment is necessary because the current regulatory framework
sufficiently prohibits the use of expired prescriptions. As a threshold
matter, Section 4(e) of the Act and Section 315.5(d) of the Rule
clearly identify three categories of invalid prescriptions (inaccurate,
expired, and otherwise invalid).\265\ Accordingly, the Act and the Rule
already make explicit that an expired prescription is not a valid
prescription. Under the Rule, sellers may only dispense lenses using
either a prescription that has been presented to the seller, or a
prescription that has been verified with the prescriber by the
seller.\266\ A prescription presented to the
[[Page 88547]]
seller must contain an expiration date in order to satisfy the
definition of contact lens prescription.\267\ If the prescription
presented to, or in possession of, the seller is expired, that
prescription is invalid and the seller cannot use the expired
prescription to dispense lenses to the patient. Because the seller has
actual knowledge that the prescription is expired, neither may the
seller use the expired prescription as the basis for a passive
verification request. If, however, a seller has been presented with, or
is in possession of, a prescription that does not contain an expiration
date, or is otherwise relying on prescription information provided by
the patient, then the seller may proceed to verify such prescription
with the prescriber.\268\ In this latter instance, the seller does not
have any knowledge as to whether or not the prescription is expired,
and can rely on the prescriber to alert the seller if the prescription
is expired.
---------------------------------------------------------------------------
\265\ 15 U.S.C. 7603(e); 16 CFR 315.5(d). See also 69 FR at
40502.
\266\ 16 CFR 315.5(a).
\267\ 16 CFR 315.2.
\268\ 16 CFR 315.5(a)(2).
---------------------------------------------------------------------------
Other commenters, recognizing that selling contact lenses on an
expired prescription is not allowed by the Rule, instead urged the
Commission to increase enforcement.\269\ The Commission believes that
the clarification regarding expired prescriptions as set forth in this
document will assist sellers in understanding their obligations under
the Rule. In addition, if the Commission receives evidence that sellers
are dispensing contact lenses based on expired prescriptions, the
Commission will investigate such allegations, as appropriate.
---------------------------------------------------------------------------
\269\ See, e.g., Peterson (Comment #222); Smith (Comment #319);
Heuer (Comment #467); Santarias (Comment #471); Johnson & Johnson
Vision Care, Inc. (Comment #582) (``critical to ensure patients
continue to see their eye care professionals for their annual check-
up and prescription renewal by upholding and enforcing the one-year
contact lens prescription expiration date''); Coalition for Patient
Vision Care Safety (Comment #621).
---------------------------------------------------------------------------
Other commenters explained that because of flaws in the passive
verification system sellers ``can request verification of an otherwise
expired prescription and can ship the lenses if the prescriber does not
recognize within eight business hours that the expiration date has
passed and inform the seller.'' \270\ In its comment, the Contact Lens
Association of Ophthalmologists argued that passive verification
``creates a mechanism for renewal of expired prescriptions, which is in
the seller's interest, may be in the consumer's immediate interest, but
is not in the interest of the consumer's long term ocular health.''
\271\
---------------------------------------------------------------------------
\270\ American Optometric Association (Comment #644). See also
Stewart (Comment #136) (stating that expired prescriptions have been
filled for years because there was no reply to passive
verification).
\271\ Comment #572. See also American Optometric Association
(Comment #644) (``[a]llowing repurchases based on long-expired
prescriptions may be, at the time, convenient for the patient and
profitable for the seller, but increases the risk of patient
harm'').
---------------------------------------------------------------------------
In its comment, the American Optometric Association noted that ``an
expiration date and issue date are required elements of a
prescription'' and the FTC ``should require the expiration date or
issue date to be provided in prescription verification.'' \272\ This
commenter argued that this requirement would incentivize sellers to
make sure patients know their prescription expiration date when placing
orders. The American Optometric Association further explained that
because sellers often market to consumers to reorder in the final month
or weeks that the prescription is valid, it believes that sellers
already know the prescription expiration date.\273\ This commenter
concluded that by requiring the expiration date or issue date in the
verification request, sellers would be aware, and could not deny when
they are using an invalid prescription.\274\
---------------------------------------------------------------------------
\272\ American Optometric Association (Comment #644).
\273\ Id.
\274\ Id.
---------------------------------------------------------------------------
The Commission declines to propose that the Rule be modified in
this way. Similar proposals were suggested and rejected during the
initial rulemaking.\275\ As the Commission recognized at that time,
there is ``no reason to believe or evidence to suggest that a seller
who is attempting to verify a prescription would necessarily have this
information.'' \276\ Furthermore, the Commission believes that adopting
such a proposal might thwart the intent of the Act. For example,
although prescribers themselves have the prescription expiration
information because they issued the prescription, a seller verifying a
prescription--as opposed to a seller who has a copy of a prescription
with an expiration date--may not have access to this information.
Because a verification request that does not contain all the required
information is not a valid verification request,\277\ sellers without
expiration information would be at a disadvantage in that they would
not be able to verify patient prescriptions based on Section
315.5(c)(3). Furthermore, as noted, prescribers are already in
possession of the expiration date, and it is in their economic and
professional interest to check the prescriptions and respond to
verification requests by informing the seller whenever a prescription
has expired.\278\
---------------------------------------------------------------------------
\275\ A state optometry association requested that the Rule be
amended to require the verification request to contain the
prescription's expiration date as well as the number of refills
prescribed. 69 FR at 40496.
\276\ Id.
\277\ Id. (``The Commission emphasizes that the sale of contact
lenses based on a verification request which does not contain all of
the required information constitutes a Rule violation.'').
\278\ See ``Fairness to Contact Lens Consumers Act: Hearing
Before the Subcommittee on Commerce, Trade, and Consumer Protection
of the House Committee on Energy and Commerce,'' 108th Cong. 1
(Sept. 12, 2003) (Testimony of Howard Beales, Federal Trade
Commission) (noting that passive verification is ``in many respects
self-enforcing'').
---------------------------------------------------------------------------
For the same reasons, the Commission declines to propose to amend
the Rule to reflect the American Optometric Association's proposal ``to
ban sellers from marketing to specific customers to reorder their
lenses after the prescription has expired (more than one year after the
issue date or when the customer originally ordered lenses from the
seller) unless the seller has specific knowledge the customer's
prescription is valid for more than one year.'' \279\ To the extent a
patient does not have a valid prescription, the Rule already prohibits
the sale of contact lenses. However, nothing in the Act supports the
extension of this prohibition to the marketing (as opposed to the sale)
of contact lenses. It may be in the patient's best interest to receive
a reminder to reorder lenses. If the patient does not have a valid
prescription, the seller is prohibited from selling the lenses.
However, if the patient has visited a prescriber in the interim, the
patient will have a valid prescription and the sale can be made.
---------------------------------------------------------------------------
\279\ American Optometric Association (Comment #644).
---------------------------------------------------------------------------
3. Quantities of Contact Lenses Obtained by Patients
Many commenters expressed the concern that because of inadequacies
in the Rule or lack of enforcement, consumers are able to obtain more
than a year's supply of contact lenses.\280\ For example, some
commenters asserted that this occurs because some contact lens
retailers allow patients to purchase
[[Page 88548]]
more than a year's supply of contact lenses,\281\ while other
prescribers reported that patients are able to refill their contact
lenses prescription and obtain more lenses just prior to the
prescription expiring.\282\ Prescribers also were concerned that they
were receiving verification requests from sellers for contact lenses
just as the patient's prescription was expiring.\283\ A number of
commenters complained that contact lens sellers are actively
encouraging patients to refill their prescriptions right before they
expire.\284\ For example, one commenter reported that sellers ``send
reminders to patients about a month before their contact lens
prescription is expired, to buy another whole year's prescription.''
\285\ One contact lens manufacturer reported that an online survey that
it had commissioned showed that 58% of the online consumers that were
surveyed indicated that they had received an email or letter from their
retailer reminding them that their prescription was expiring soon and
that the majority of these consumers had ordered more lenses as a
result.\286\ Other commenters noted that patients are able to obtain
more than a year's supply of contact lenses by ordering from multiple
sources.\287\
---------------------------------------------------------------------------
\280\ See, e.g., Rohleder (Comment #57) (``Because of lack of
enforcement, patients are able to purchase more contact lenses than
they can use in a year, thus allowing them to circumvent seeing
their doctor almost indefinitely.''); Filandro (Comment #129) (``A
patient can order ten years' worth of contacts and can't be stopped
by the law. A patient can order one years' [sic] worth of contacts
from ten different vendors and can't be stopped by the law.'');
Stewart (Comment #136) (``Patients are able to purchase multi-years
[sic] worth of contact lenses even though the prescription clearly
states expires in one year.''); Tjandera (Comment #502) (noting that
the Rule can be evaded because patients can order from multiple
online retailers before the prescription expires).
\281\ Young (Comment #91); Anklin (Comment #107); American
Optometric Association (Comment #644).
\282\ Day (Comment #4); Driesen (Comment #47); Schwartz (Comment
#80); Magee (Comment #95); Johnson (Comment #109); Rosemore (Comment
#468); Garcia (Comment #511). See also Milsky (Comment #559)
(``Another common concern among prescribers is, for example, a
prescription for a year's supply of contact lenses getting filled
one month before it expires, eleven months after the exam and
fitting.'').
\283\ Shin (Comment #70); Young (Comment #91); Chakuroff
(Comment #189); Koury (Comment #573).
\284\ Mathai (Comment #33) (``1800 contacts and other retailers
prompt their customers to purchase an annual supply right before
their prescription expires so they can save a trip to their Dr [sic]
office.''); Jones (Comment #83) (``Contact lens suppliers are
actively targeting patients to get them to order outside the limits
of the prescription and/or fishing for patient information.'');
Young (Comment #91) (``Some online retailers are actively marketing
to consumers to purchase more contact lenses when their prescription
is `about to expire'.''); Nelson (Comment #130) (``1-800 Contacts
also will not respect a number of refills on the Rx. Instead, they
will email the patient before their Rx expires and tell them to
order more. Patients then order another year of contacts and then
cancel their yearly examination.''); Hans (Comment #168) (patients
prompted to save trip to doctor's office); Ellenberger (Comment
#272) (same); Gandy (Comment #530) (stop sellers from aggressive and
unethical practice of encouraging patients to buy another years'
supply of lenses right before their prescription expires); Tass
(Comment #586) (same).
\285\ Combs (Comment #90).
\286\ Johnson & Johnson Vision Care, Inc. (Comment #582)
(``nearly six-in-ten online consumers say they have received an
email or letter from their retailer reminding them their Rx was
expiring soon (58%) and the vast majority who received this notice
(86%) ordered more contacts as a result'').
\287\ Jones (Comment #83); Filandro (Comment #129); Heuer
(Comment #467); Endry (Comment #552); Milsky (Comment #559).
---------------------------------------------------------------------------
As explained by other commenters, if patients can obtain lenses in
excess of a year's supply, expiration dates on prescriptions become
meaningless \288\ and patients do not return to their eye care
professional on an annual basis.\289\ Some prescribers provided
anecdotal reports of patients not returning for an annual eye exam,
sometimes for several years, because they had been able to purchase
contact lenses online.\290\
---------------------------------------------------------------------------
\288\ Mirkin (Comment #111); Endry (Comment #552). See also
Harris (Comment #490) (purchasing contacts right before the
prescription expires defeats the purpose of annual expiration dates
and the monitoring of patient eye health).
\289\ See, e.g., Rohleder (Comment #57); Buthod (Comment #81);
Moody (Comment #92); Anklin (Comment #107); Nett (Comment #449);
Lisenby (Comment #662).
\290\ See, e.g., Weissman (Comment #50) (five years); Grace
(Comment #64) (several years); Buthod (Comment #81) (3-5 years);
Patel (Comment #188) (companies filling prescriptions for 10 years
without successful verification); Pentecost (Comment #268); Silani
(Comment #270) (returning for an exam ``years'' later); Chea
(Comment #352); Arthur (Comment #371) (five years); Hornberger
(Comment #457) (as many as five years); Pickering (Comment #475)
(four to five years); Born (Comment #570) (many years); Gronquist
(Comment #630) (years).
---------------------------------------------------------------------------
To address these concerns, a number of commenters--optometric and
ophthalmologic associations, individual prescribers, and contact lens
manufacturers--proposed that the Commission amend the Rule to require
contact lens prescriptions to include a maximum quantity of lenses that
consumers can purchase prior to the prescription's expiration.\291\
These commenters asserted that including a quantity limit on
prescriptions would be beneficial to patients' health and safety.\292\
One contact lens manufacturer stated that quantity limits ``impose
important safeguards and also strengthen the prescriber-patient
relationship,'' arguing that if a patient runs out of contact lenses,
this would ``offer[] yet another opportunity for consumers to ask
questions, share health and other issues they may be encountering with
their lenses, or adjust their prescription under the supervision of an
eye care professional.'' \293\
---------------------------------------------------------------------------
\291\ American Optometric Association (Comment #644); American
Academy of Optometry (Comment #623); Virginia Optometric Association
(Comment #16); Wisconsin Optometric Association (Comment #30); Utah
Optometric Association (Comment #39); Pennsylvania Optometric
Association (Comment #46); Alabama Optometric Association (Comment
#48); Iowa Optometric Association (Comment #79); Michigan Optometric
Association (Comment #86); California Optometric Association
(Comment #119); New Mexico Optometric Association (Comment #211);
Mississippi Optometric Association (Comment #548); Ohio Optometric
Association (Comment #556); Connecticut Association of Optometrists
(Comment #560); North Carolina State Optometric Society (Comment
#567); Tennessee Association of Optometric Physicians (Comment
#575); Colorado Optometric Association (Comment #584); New Jersey
Society of Optometric Physicians (Comment #595); Coalition for
Patient Vision Care Safety (Comment #621); Stahl (Comment #19); Lum
(Comment #21); Peterson (Comment #22); Maanum (Comment #23);
Matthews (Comment #25); Borsky (Comment #26); Chriqui (Comment #31);
Hodes (Comment #42); Dodge (Comment #44); Kapoor (Comment #58);
Comer (Comment #221); Leach (Comment #257); Chang (Comment #258);
Whang (Comment #355); Knight (Comment #360); Senator Perdue (Comment
#569); Reed (Comment #579); Johnson & Johnson Vision Care, Inc.
(Comment #582); Leung (Comment #607); Wu (Comment #608); Vidulich
(Comment #612); Lai (Comment #620); Pechko (Comment #628); Liu
(Comment #656); Louie (Comment #657); Fong (Comment #669); Vo
(Comment #673).
\292\ See, e.g., American Optometric Association (Comment #644).
\293\ Johnson & Johnson Vision Care, Inc. (Comment #582).
---------------------------------------------------------------------------
In addition to including the maximum quantity on the prescription
itself, several state optometric associations also recommended that the
Commission ``limit the number of contact lens boxes that can be
purchased from a retailer at one time.'' \294\ Similarly, the Coalition
for Patient Vision Care Safety proposed that the Commission ``forbid
retailers to sell in a single transaction a quantity of contact lenses
that exceeds a single year's supply.'' \295\ As an alternative, the
Coalition suggested the Commission require that sellers only provide a
supply equal to the length of the underlying prescription.\296\ A few
commenters stated that because passive verification might allow the
consumer to obtain more lenses than medically prescribed, quantity
limits should be considered.\297\
---------------------------------------------------------------------------
\294\ Virginia Optometric Association (Comment #16); Wisconsin
Optometric Association (Comment #30); Utah Optometric Association
(Comment #39); Pennsylvania Optometric Association (Comment #46);
Alabama Optometric Association (Comment #48); Iowa Optometric
Association (Comment #79); Michigan Optometric Association (Comment
#86); California Optometric Association (Comment #119); New Mexico
Optometric Association (Comment #211); Mississippi Optometric
Association (Comment #548); Ohio Optometric Association (Comment
#556); Connecticut Association of Optometrists (Comment #560); North
Carolina State Optometric Society (Comment #567); Tennessee
Association of Optometric Physicians (Comment #575); Colorado
Optometric Association (Comment #584); New Jersey Society of
Optometric Physicians (Comment #595).
\295\ Comment #621.
\296\ Id. See also Dierks (Comment #32); Ellingson (Comment
#66); Moody (Comment #92); Bhadra (Comment #105); Rana (Comment
#139); Patel (Comment #237); Santry (Comment #529).
\297\ Wilson (Comment #76) (passive verification allows the
contact lens seller to sell the patients more lenses than are
medically prescribed); Kline (Comment #161) (same); Johnson &
Johnson Vision Care, Inc. (Comment #582).
---------------------------------------------------------------------------
A number of commenters argued that contact lens prescriptions
should be
[[Page 88549]]
treated the same way as pharmaceutical prescriptions in order to
prevent the dispensing of excess quantities.\298\ As described by one
commenter, this would require the quantity to be included on the
prescription and the retention of the prescription by the dispenser
filling it.\299\ A few commenters suggested a pro rata approach. For
example, one prescriber recommended that consumers should only be able
to obtain refills commensurate with the amount of time left on the
prescription.\300\ Likewise, the Coalition for Patient Vision Safety
proposed a similar approach, suggesting that the Commission ``restrict
the sale of contact lenses on a prescription that is nine months after
issuance or older to up to 25 percent of the prescription's course.''
\301\ One contact lens manufacturer recommended that the Commission
modify the Rule to ``place[] reasonable limits on the quantity of
contact lenses a patient can purchase under a prescription (especially
within a few months of a prescription expiring)'' in order to encourage
patients to go to their eye care professional for routine
examinations.\302\
---------------------------------------------------------------------------
\298\ See, e.g., Filandro (Comment #129); Kalman (Comment #150);
Bainbridge (Comment #152); Anderson (Comment #185); Palermo (Comment
#212); Sanders (Comment #235); Sanders (Comment #236); Smith
(Comment #319); Chesen (Comment #350); Perichak (Comment #415);
Witmeyer (Comment #418); Palmer (Comment #484); Pierzchala (Comment
#500); Haefs (Comment #525); Johnson & Johnson Vision Care, Inc.
(Comment #582); Tass (Comment #586); Ball (Comment #590); Alexander
(Comment #666).
\299\ Kalman (Comment #150).
\300\ See, e.g., Milsky (Comment #559).
\301\ Comment #621.
\302\ CooperVision, Inc. (Comment #591).
---------------------------------------------------------------------------
However, other commenters disagreed with the proposal to include
quantity limits on contact lens prescriptions. 1-800 CONTACTS argued
that imposing quantity limits would ``inconvenience consumers and lead
to unhealthy practices, such as wearing lenses longer than
recommended.'' \303\ This commenter asserted that patients could
misplace or tear lenses, or might replace their lenses more frequently
than anticipated by their prescription, and consequently concluded that
``there are any number of very legitimate reasons a consumer may want
to purchase what appear to be (based on simple multiplication) extra
lenses and there is no valid reason to restrict that consumer's
options.'' \304\
---------------------------------------------------------------------------
\303\ Comment #568.
\304\ Id.
---------------------------------------------------------------------------
Another contact lens retailer claimed that prescribers were
circumventing the minimum one-year expiration period by ``limit[ing]
the quantity of replacement lenses, despite the lack of any medical
reason for ever doing so'' and that ``a consumer's need for additional
lenses could arise for a number of reasons.'' \305\ This commenter
proposed that the Commission amend Section 315.6 of the Rule to include
a provision stating that a ``contact lens prescription shall be valid
for an unlimited quantity of lenses regardless of any prescriber-
imposed limitation to the contrary.'' \306\
---------------------------------------------------------------------------
\305\ LD Vision Group (Comment #544).
\306\ Id.
---------------------------------------------------------------------------
After reviewing the comments, the Commission has determined not to
propose to amend the Rule to adopt any of the contact lens quantity
proposals put forth by commenters. First, the Commission does not
believe that there is sufficient evidence in the rulemaking record to
support amending the Rule to impose the quantity limit proposals
suggested by commenters. Although some commenters conducted and
submitted data from online surveys for the proposition that consumers
are purchasing contact lenses as their prescriptions are about to
expire, this data does not show the quantity of lenses that consumers
are actually purchasing. For example, even if one were to assume that
the APCO online survey results were completely reliable, the survey
only asked consumers whether they purchased lenses at certain points in
time; it did not assess the quantity of lenses that consumers actually
purchased. The fact that a consumer purchased some contact lenses just
prior to a prescription expiring does not necessarily mean that the
consumer has purchased an excessive amount of contact lenses, nor does
it support the contention that consumers are no longer getting eye
examinations. Instead, consumers could be purchasing small amounts of
lenses to last until their next scheduled eye examination. When the
Commission examined the contact lens industry in 2005, it found that
consumers do not typically purchase a full year's supply at one
time.\307\ The Commission has not seen any evidence indicating that
this has changed. Although commenters to the current Rule review
provided various anecdotal and hypothetical accounts of consumers
buying excessive quantities of lenses, they did not provide empirical
evidence regarding the amount of lenses consumers are obtaining, nor
did they submit evidence to show that consumers are not visiting their
eye care practitioners as frequently.\308\ Second, regardless of the
evidence, or lack thereof, in the record to support the quantity limit
proposals, the Commission believes that it would be difficult to
administer the proposed limits, and that rather than increasing patient
eye health and safety, such proposals could have the opposite effect.
For example, if a consumer is running out of contact lenses and does
not have time to see a prescriber promptly, there is a significant
chance that the consumer will not adhere to the recommended contact
lens replacement schedule and will instead try to ``stretch out'' their
lenses by re-wearing them until they can visit a prescriber. The
failure to replace lenses is a well-documented cause of many contact-
lens-related health issues.\309\ Absent empirical evidence that a
substantial number of consumers are obtaining excessive amounts of
contact lenses, or are not returning to their prescribers for eye
examinations, the Commission believes that the risk of not replacing
lenses outweighs the harm of consumers obtaining more lenses than
strictly anticipated by the length of a contact lens prescription.
---------------------------------------------------------------------------
\307\ 2005 Contact Lens Report, supra note 14, at 6 note 18
(citing two studies that found that just 12-20% of consumers
purchase a year's supply at a time).
\308\ Indeed, the Coalition for Patient Vision Care Safety
indicated that ``87 percent of contact lens patients had an eye exam
last year.'' Comment #621.
\309\ Cope, supra note 29, at 867 (``contact lens wearers who do
not follow recommended contact lens replacement schedules have more
complications and eye discomfort'').
---------------------------------------------------------------------------
Nevertheless, the Commission is concerned about anecdotal reports
that sellers are contacting patients and encouraging them to stockpile
contact lenses prior to the expiration of their prescriptions in order
to avoid visiting their eye care professionals. The Commission cautions
sellers that such practices run counter to the spirit of the Act, and
the Commission will look closely at these alleged practices.
The Commission also declines to propose that the Rule be amended to
provide that a ``contact lens prescription shall be valid for an
unlimited quantity of lenses regardless of any prescriber-imposed
limitation to the contrary.'' \310\ The commenter suggesting this
amendment produced no evidence supporting the allegation that
prescribers are using quantity limits to undercut the length of a
prescription.
---------------------------------------------------------------------------
\310\ LD Vision Group (Comment #544).
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The Commission also notes that, as recognized during the initial
rulemaking, some State laws or regulations may require prescribers to
include quantity information on the prescription and some prescribers
in other States without such requirements
[[Page 88550]]
may choose to include such information on the prescription. At this
time, the Commission reiterates that such prescribers must not use
quantity limits to frustrate the prescription expiration requirements
of Section 315.6, and that the quantity specified in the prescription
must be sufficient to last through the prescription's expiration
date.\311\
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\311\ 69 FR at 40488. If the prescription specifies a lesser
quantity of lenses or refills, the prescriber must have a legitimate
medical reason for doing so, and the requirements imposed by Section
315.6(b) on writing a prescription for less than one year must be
met. Id.
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Finally, the Commission also believes that the Rule, as currently
drafted, is sufficient to address the quantity limit concerns posited
by commenters. During the initial rulemaking, the Commission examined
the issue of requiring quantity limits on prescriptions.\312\ At that
time, the Commission concluded that it was not necessary to include the
quantity of lenses on the prescription to limit patients' ability to
circumvent the expiration date because the verification process would
allow prescribers to prevent patients from ordering excessive contact
lenses.\313\ In this rule review, commenters raised concerns that the
verification process was not an adequate safety net because the
``verification process is not triggered when a patient provides a
contact lens retailer with a complete copy of prescription'' and the
verification process is bypassed.\314\ Accordingly, it is possible that
consumers could use a copy of a prescription to shop at multiple
retailers, or engage in other practices, in order to obtain excessive
amounts of contact lenses.\315\ Although it is possible that these
practices could occur, there is no empirical evidence in the record to
show the frequency or extent of such practices.\316\
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\312\ In reaching that determination, the Commission first noted
that the Act did not require the inclusion of quantity information
on the prescription. The Commission then discussed its concern that
if quantity information was included, prescribers might use those
quantity limits to impose prescription expiration dates that are
effectively shorter than the one-year period imposed under the Act.
69 FR at 40488.
\313\ 69 FR at 40488 (explaining that Section 315.5(b) requires
verification requests to contain the quantity of lenses ordered, and
that the quantity ordered may be a legitimate basis for a prescriber
to treat a request for verification of a prescription as
``inaccurate'').
\314\ American Optometric Association (Comment #644). See also
Coalition for Patient Vision Care Safety (Comment #621).
\315\ Id.
\316\ For the same reasons, the Commission also declines to
propose to amend the Rule per the American Optometric Association's
proposal that the Commission limit the quantity of contact lens
boxes that retailers advertise as being able to be purchased at one
time. Comment #644. In its comment, the American Optometric
Association contended that it is possible that consumers could
purchase large amounts of contact lenses from some online retailers;
however, it did not provide support for this contention.
---------------------------------------------------------------------------
Other commenters encouraged the Commission to increase enforcement
efforts to prevent consumers from obtaining more contact lenses than
anticipated by the length of the prescription.\317\ As already noted,
if the Commission receives evidence that sellers are dispensing contact
lenses in violation of the Rule, the Commission will investigate such
allegations, as appropriate.
---------------------------------------------------------------------------
\317\ See, e.g., Day (Comment #4); Mathai (Comment #33); Nelson
(Comment #130); Hans (Comment #168); Garcia (Comment #511); Gandy
(Comment #530); Tass (Comment #586).
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B. Private Label Lenses and Contact Lens Substitution
1. Private Label Lenses
A few sellers commented on the Rule provision regarding private
label lenses.\318\ Section 315.2 of the Rule defines private label
contact lenses as ``contact lenses that are sold under the label of a
seller where the contact lenses are identical to lenses made by the
same manufacturer but sold under the labels of other sellers.'' \319\ A
prescription for private label contact lenses, in addition to other
required information, must include the name of the manufacturer, trade
name of the private label brand, and if applicable, trade name of
equivalent brand name.\320\ The Rule's requirements for private label
lens prescriptions track the language of the Act.\321\ Although most
contact lenses are sold under their national brand name, some
manufacturers also distribute their lenses to prescribers and retailers
under private labels. Sometimes the private label is unique to that
seller and other times the private label brand may be available at
multiple outlets.\322\
---------------------------------------------------------------------------
\318\ LD Vision Group (Comment #544); 1-800 CONTACTS (Comment
#568).
\319\ 16 CFR 315.2.
\320\ Id.
\321\ See 15 U.S.C. 7610(3).
\322\ 2005 Contact Lens Report, supra note 14, at 14-15.
---------------------------------------------------------------------------
LD Vision Group, an online contact lens retailer, asserted that
manufacturers and prescribers design anticompetitive strategies
involving private label lenses to ``thwart consumer freedom.'' \323\
Specifically, the company contended that to keep consumers from
purchasing contacts elsewhere, some prescribers ``will provide
unpopular or private-label lenses without published equivalents or for
which the equivalents are confusing.'' \324\ For instance, the company
stated that one private label ``is purportedly available with an 8.3 or
8.6 base curve, while the brand name lens--though it is the exact same
lens--is purportedly available with an 8.4 or 8.7 base curve.'' \325\
Another manufacturer, according to LD Vision Group, ``offers four
different lenses under a private label: Standard, plus, premium, and
premium plus, but the national-label equivalents do not use the same
identifiers.'' \326\ Although prescribers are required by the Rule to
list equivalent information on the prescription, LD Vision Group
asserted that prescribers do not always comply, and absent
manufacturers' identification of equivalent lenses, ``the retailer must
either refuse to dispense unknown equivalents or make assumptions based
on intentionally misleading private-label designations and risk
dispensing the wrong lenses to the potential detriment of their
customers' eye health.'' \327\ LD Vision Group did not quantify the
extent of this problem, or provide empirical evidence as to its
scope.\328\
---------------------------------------------------------------------------
\323\ Comment #544. LD Vision Group explained that manufacturers
acquiesce to prescribers because it is the prescribers who select
their patients' contact lenses. Id.; see also 1-800 CONTACTS
(Comment #568) (commenting on manufacturers' strong incentives to
cater to the interests of prescribers rather than consumers because
prescribers determine the brand and modality of their patients'
lenses).
\324\ Comment #544.
\325\ LD Vision Group did not identify the private label or
manufacturer engaged in this practice. Comment #544.
\326\ Id.
\327\ As discussed in Section V.B.2, infra, when sellers
substitute lenses that are not identical to the prescribed contact
lenses, they violate the Rule.
\328\ The Commission understands that sales of private label
lenses comprise a small part of the market, and most major
manufacturers do not sell private label lenses.
---------------------------------------------------------------------------
In order to remedy the aforementioned issues, LD Vision Group
proposed that the Commission amend the Rule to require prescribers to
annotate a private label lens prescription with the brand-name
equivalent and, if a name-brand equivalent is unavailable, the private
label prescription must be medically necessary for that particular
patient. It also recommended requiring manufacturers of contact lenses
to disclose brand equivalency information on private label and brand-
label packaging, or otherwise make it available to sellers.\329\
---------------------------------------------------------------------------
\329\ LD Vision Group (Comment #544).
---------------------------------------------------------------------------
The Commission declines to propose to modify the Rule to implement
these recommendations. Although the Act expressly requires that, in the
case of private label contact lens prescriptions, prescribers include
``trade name of equivalent brand name,'' the Act does
[[Page 88551]]
not impose a requirement of medical necessity in order for a prescriber
to prescribe a private label lens for which no name-brand equivalent
exists.\330\ Nor does the Act expressly contemplate the imposition of
disclosure requirements on manufacturers. However, nothing in the Act
or Rule prohibits manufacturers from making brand equivalency
disclosures on their packaging, or otherwise making such information
available to sellers. The Commission understands that some, if not all,
manufacturers who offer private labels already make this information
readily available to retailers. Additionally, the Commission notes that
it is a violation of the Rule for prescribers to fail to comply with
their obligation to specify a brand equivalent, should one exist, when
writing a prescription. The Commission encourages sellers and consumers
to submit evidence of any such violations to the agency for possible
enforcement action.
---------------------------------------------------------------------------
\330\ In the initial rulemaking, sellers made a recommendation
to open up the market by requiring prescribers, when prescribing
private label contact lenses, to identify on the prescription the
name of a brand that a consumer could purchase from a retailer other
than the prescribing office. 69 FR at 40503. The Act does not limit,
in any way, the brand that a prescriber must select and thus, the
Commission concluded that such a requirement would go beyond the
Act. Id. LD Vision Group's similar proposal to limit prescribers
from prescribing private label brands without a brand-equivalent,
except in the case of medical necessity, fails for the same reason.
---------------------------------------------------------------------------
2. Alteration of Contact Lens Prescriptions by Sellers
Section 315.5(e) of the Rule prohibits sellers from altering a
contact lens prescription.\331\ Notwithstanding this prohibition, a
seller may substitute for private label contact lenses specified on a
prescription, ``identical contact lenses that the same company
manufactures and sells under different labels.'' \332\ The language of
this Rule provision is substantively the same as the language of the
Act, with one exception discussed below.\333\
---------------------------------------------------------------------------
\331\ 16 CFR 315.5(e).
\332\ Id.
\333\ See 15 U.S.C. 7603(f).
---------------------------------------------------------------------------
The Commission received a number of comments, primarily from
prescribers, that complained that online contact lens sellers are
selling patients lenses different from those they prescribed.\334\
Prescribers expressed concern that contact lenses are being treated
like commodities, rather than restricted medical devices regulated by
the FDA.\335\ These commenters contended that contact lenses, even
those with similar refractive specifications, are not
interchangeable.\336\ One commenter, a manufacturer, opined that ``each
brand is unique and proprietary to each manufacturer and designed to
suit a different set of corresponding patient physiology and consumer
needs.'' \337\
---------------------------------------------------------------------------
\334\ See, e.g., Kapoor (Comment #58); Narayan (Comment #60);
Thomas (Comment #61); Weinberg (Comment #87); Anderson (Comment
#96); Hopkins (Comment #102); Johnson (Comment #109); O'Brien
(Comment #127); Stewart (Comment #136); Hans (Comment #168);
Hamilton (Comment #216); Gibson (Comment #217); Cassis (Comment
#233); Chesen (Comment #321); Silver (Comment #349); McWilliams
(Comment #362); Wittmann (Comment #421); Nett (Comment #449); Eggers
(Comment #473); Kegarise (Comment #477); Kosunick (Comment #501);
Wren (Comment #520); Lai (Comment #541); Hamada (Comment #603);
Coalition for Patient Vision Care Safety (Comment #621); Maceyko
(Comment #642); American Optometric Association (Comment #644).
\335\ Kelly (Comment #78); Callihan (Comment #187); Sancho
(Comment #226); West (Comment #230); Nett (Comment #449); Vu
(Comment #561); Reed (Comment #579). Cf. LD Vision Group (Comment
#544) (calling lenses a ``disposable commodity'').
\336\ See, e.g., Johnson & Johnson Vision Care, Inc. (Comment
#582) (citing studies supporting this statement). A number of
commenters similarly explained that because each contact lens fits
the eye differently, there is no such thing as a generic contact
lens. See, e.g., Jones (Comment #63); Miyamura (Comment #77); Jones
(Comment #83); Easton (Comment #432).
\337\ Comment #582. Johnson & Johnson Vision Care, Inc.
described several parameters that make a contact lens brand unique,
including oxygen transmissibility, water content, iconicity,
rigidity or modulus, silicone and fluorine content, lipid
deposition, wettability/wetting agent, thickness, diameter, base
curve, edge design, surface characteristics/treatments, modality, UV
blocking, and interaction with care solutions. Other commenters
mentioned modality (daily, two week replacement, or monthly),
optical clarity, lifestyle, medical conditions, and current
medications as factors influencing the prescriber's selection of the
contact lens to prescribe. Morgan (Comment #144); Assell (Comment
#397).
---------------------------------------------------------------------------
Several prescribers and a manufacturer also explained that
prescribers work with patients to fit them with the most compatible,
safe, and effective contact lens and that each patient's eyes react
differently to individual brands.\338\ According to these commenters,
when a patient receives a contact lens that is not identical to the one
prescribed, those lenses have not been fit on the patient, may not be
appropriate, and can even be harmful for the patient.\339\
Specifically, prescribers stated that scarring, infection, allergic
reactions, corneal ulcers, impaired or even lost vision can result or
have resulted from patients wearing lenses that were not
prescribed.\340\ A few prescribers described patients who, after
wearing lenses that had not been prescribed for them, could no longer
wear contact lenses or whose vision could no longer be fully
corrected.\341\
---------------------------------------------------------------------------
\338\ See Sasner (Comment #182); Williams (Comment #261);
Steinleitner (Comment #517); Nielson (Comment #565) (prescriber
questioning why he learned how to fit contact lenses if patients can
get any lens they want without his input); Johnson & Johnson Vision
Care, Inc. (Comment #582).
\339\ Id.
\340\ Williford (Comment #38); Kapoor (Comment #58); Jones
(Comment #63); Morgan (Comment #144); Herve (Comment #148); Sausner
(Comment #182); McWilliams (Comment #362); Elmore (Comment #396);
Wittmann (Comment #421); Kegarise (Comment #447); Sirotkin (Comment
#464); Abbott (Comment #497); Wren (Comment #520); Evans (Comment
#523); Hamada (Comment #603); Capps (Comment #610); Coalition for
Patient Vision Care Safety (Comment #621); Vehab (Comment #622);
Mortenson (Comment #636); Maceyko (Comment #642).
\341\ Schram (Comment #184); McWilliams (Comment #362).
---------------------------------------------------------------------------
As to the source of the alteration problem, commenters pointed to
both online sellers as well as patients. Commenters, almost exclusively
prescribers, asserted that sellers want to maximize their profits and
may have little to no consideration for their customers' eye
health,\342\ and that patients switch brands to obtain cheaper lenses
or seek brands they have seen in commercials.\343\ Some prescribers
also stated or implied that these substitutions occur as a result of
the passive verification system, and encouraged the Commission to adopt
an active verification system.\344\
---------------------------------------------------------------------------
\342\ Nguyen (Comment #82); Eggers (Comment #473); Lupinski
(Comment #499); Nielsen (Comment #565). Other prescribers are
concerned that they will be liable or at risk of losing their
licenses if the substitution causes the consumer harm. See, e.g.,
Carroll (Comment #5); Thomas (Comment #61).
\343\ LaDouceur (Comment #178); Schram (Comment #184); Marler
(Comment #504); Vehab (Comment #622).
\344\ Prescribers contend that after sellers convince patients
to order different lenses than those prescribed, or patients give
sellers the name of a lens not identical to the prescribed lens, the
sellers send a verification request containing the non-prescribed
lenses, and those requests are sometimes passively verified. Eggers
(Comment #473); Wren (Comment #520). As previously explained, see
supra Section IV.C.1, the Commission lacks authority to eliminate
the passive verification system.
---------------------------------------------------------------------------
It is unclear how frequently illegal substitutions are occurring,
or how many sellers are engaged in this activity. In its comment,
Johnson & Johnson Vision Care, Inc. cited to a 2015 online survey
conducted on its behalf that found that ``one-in-four online consumers
report having received a different brand of contact lenses than they
had ordered without being given advanced warning they were getting
another brand.'' \345\ Even assuming the survey methodology is sound
and the stated conclusion of the survey is accurate, it is not clear
whether the positive responses reflect instances
[[Page 88552]]
when sellers made illegal alterations or, alternatively, instances when
consumers ordered a brand other than the prescribed brand and the
prescribers then corrected the prescriptions. Nor is it clear whether
positive responses include instances where eye care professionals
prescribed private label lenses and sellers appropriately substituted
them with identical lenses, made by the same manufacturer and sold
under a different label, as expressly permitted by Section 315.5(e).
Because one cannot tell the percentage that was the result of
unauthorized alterations, the survey data is not conclusive.\346\
---------------------------------------------------------------------------
\345\ Comment #582.
\346\ Other seemingly relevant survey questions, one of which a
commenter cited to, may be similarly flawed. For example, the
Coalition for Patient Vision Care Safety pointed out that 31% of
respondents answered positively when asked: ``When buying contact
lenses online or over the phone in the past, has the company you
were ordering from ever informed you that they do not carry or do
not currently have stocked, the brand of contact lenses on your
prescription, and advised you to get another brand of contact lenses
instead?'' Comment #621. In response to a subsequent survey
question, 80% of those respondents indicated that they ``then
order[ed] that other brand of contact lenses.'' The Commission notes
that positive responses to these questions do not necessarily
reflect a violation of the Rule. For example, a prescriber changing
a prescription to a different lens in the interim would thereby
render the sale proper.
---------------------------------------------------------------------------
The Commission notes that unauthorized alterations violate the Rule
as currently written, and thus there is no need to amend the Rule to
address this issue.\347\ In some cases, patients may request to
purchase a brand of lenses not identical to the one prescribed. In
those instances, the seller may include the wrong brand in the
verification request. If any of the information required by Section
315.5(b)(2) to be included in the verification request is incorrect,
prescribers are encouraged to provide the correct information to the
seller.
---------------------------------------------------------------------------
\347\ Because prescription alteration violates the Rule, the
Commission need not make its own assessment of Johnson & Johnson
Vision Care, Inc.'s and numerous prescribers' statements concerning
the non-interchangeability of lenses and the resulting eye health
risks.
---------------------------------------------------------------------------
Several commenters requested that the Commission better enforce the
Rule against sellers that engage in illegal substitutions.\348\ If the
Commission receives evidence that sellers are engaged in illegal
substitutions, the Commission will investigate the allegations, as
appropriate.\349\
---------------------------------------------------------------------------
\348\ Thomas (Comment #61); Lai (Comment #541); Johnson &
Johnson Vision Care, Inc. (Comment #582).
\349\ The Commission notes that the prescriber has the ability
to block an illegal substitution by actively responding to a
verification request for a non-prescribed lens and indicating its
invalidity. In fact, in circumstances where a consumer selects a
non-prescribed brand, the prescriber is likely the only one who can
``catch'' the error.
---------------------------------------------------------------------------
Lastly, one commenter, an optometrist, recommended that a retailer
should be required to warn or educate patients about the potential
consequences of changing brands or other parameters without a doctor's
authorization through a ``statement of education'' with every order,
warning patients that ``contact lenses are a medical device and the
wearing of or changing of a brand or prescription without a doctor's
authorization is illegal and could result in damage, even blindness to
the recipient.'' \350\ The Commission declines to modify the Rule in
such a fashion. Although the Commission does not take issue with the
importance of educating patients about the need to consult their
prescriber before switching contact lens brands, and encourages
sellers, prescribers, and manufacturers to do so, we have no evidence
that the benefit of imposing such a requirement on sellers would
outweigh the costs.
---------------------------------------------------------------------------
\350\ Kegarise (Comment #447).
---------------------------------------------------------------------------
Through discussions with industry members, it has come to the
Commission's attention that in addition to prescribers, some other
sellers market and sell private label contact lenses that are identical
to, and are made by the same manufacturer as, brand name contact
lenses. As a result, when a patient presents a contact lens
prescription for brand name contact lenses to certain sellers, those
sellers may wish to sell, as a substitute, their own private label
lenses to the patient. The language of the Act clearly permits
substitution in cases where the same contact lenses are manufactured by
the same company and sold under multiple labels to individual
providers.\351\ Although the Rule similarly permits a seller to
substitute lenses that are identical to, and are made by the same
manufacturer as, the one listed on the prescription,\352\ the language
set forth in Section 315.5(e) of the Rule could be read to limit such
substitution to instances where private label lenses are listed on the
prescription and the seller wishes to substitute brand name
lenses.\353\
---------------------------------------------------------------------------
\351\ 15 U.S.C. 7603(f).
\352\ 16 CFR 315.5(e).
\353\ Section 315.5(e) modifies ``contact lenses'' with the term
``private label,'' but the Act does not contain that modifier. Cf.
15 U.S.C. 7603(f).
---------------------------------------------------------------------------
The Commission recognizes that the current construction of Section
315.5(e) of the Rule does not conform to the language or intent of the
Act. The clear language of the Act allows sellers to substitute private
label lenses for brand name lenses when the substituted lenses are
``manufactured by the same company and sold under multiple labels to
individual providers.'' \354\ To conform the Rule to the Act, the
Commission proposes to strike the words ``private label'' from Section
315.5(e) and seeks comment on its proposal. The definitions in the Rule
of a ``contact lens prescription'' and of a ``private label contact
lens'' would remain unchanged.
---------------------------------------------------------------------------
\354\ 15 U.S.C. 7603(f). Although the Commission imagines it
would be quite rare, it believes a seller should be permitted under
the Rule to substitute one private label lens for another private
label lens as long as the lenses are identical.
---------------------------------------------------------------------------
C. HIPAA Issues
The Commission received a few comments that identified concerns
with how the Rule's verification framework interacts with the Health
Insurance Portability and Accountability Act of 1996 \355\ (``HIPAA'')
Privacy and Security Rules (``HIPAA Rules'').\356\ One prescriber
expressed the opinion that the Contact Lens Rule's verification system
was in direct conflict with HIPAA and detailed his attempts to procure
HIPAA authorizations from his patients prior to releasing the
prescription to a third-party seller.\357\ Another commenter
recommended that HIPAA should apply to the verification process and
that any verification request should be accompanied by an authorization
signed by the patient.\358\ A third commenter expressed concern that
automated telephonic verification requests were in direct violation of
HIPAA because the patient's personal information was relayed to the
person answering the telephone, without any mechanism to ensure that it
was the intended recipient.\359\ A few prescribers also complained that
sellers' practices of trying to obtain prescriptions without patient
authorization violated HIPAA.\360\
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\355\ Public Law 104-191 (Aug. 21, 1996).
\356\ 45 CFR parts 160, 164.
\357\ Ciszek (Comment #134).
\358\ Pao (Comment #181).
\359\ Stuart (Comment #635) (consumers' ``personal and medical
information is currently being transmitted unsecured to a third
party by using an automated phone verification system'').
\360\ St. Martin (Comment #292) (``their phishing for
prescriptions should be considered a HIPAA violation because often
this is done without the patient's permission''). See also Vensand
(Comment #59) (expressing concern about the acquisition and sale of
patient information); Ciszek (Comment #134) (complaining that
sellers are calling of their own accord, without the patient
initiating the request).
---------------------------------------------------------------------------
Other commenters stated that some prescribers were not complying
with the Contact Lens Rule and were using HIPAA to avoid doing so. One
seller complained that ``[s]ome prescribers will still refuse to verify
even with the law in place, stating (incorrectly) that HIPAA or a state
privacy rule prohibits
[[Page 88553]]
release of the prescription and that only the patient can ask for it.''
\361\ Likewise, the National Association of Optometrists and Opticians
noted that it was ``aware of instances where prescribers incorrectly
inform patients that HIPAA or other laws require a written
authorization from the patient or face-to-face requests by the patient
to the prescriber.'' \362\ This commenter recommended that the
Commission make clear to prescribers, sellers, and consumers that HIPAA
does not prevent compliance with the Rule's verification process and
that to claim otherwise is an unfair and deceptive practice.\363\
---------------------------------------------------------------------------
\361\ LD Vision Group (Comment #544).
\362\ Comment #549.
\363\ Id.
---------------------------------------------------------------------------
The Commission reiterates that the HIPAA Privacy Rule does not
restrict prescribers' ability to provide or verify contact lens
prescriptions under the Rule.\364\ As a preliminary matter, HIPAA does
not require submission of a HIPAA authorization for the prescriber to
release a contact lens prescription to a patient.\365\ Furthermore, as
the Commission explained in the initial rulemaking, the HIPAA Privacy
Rule permits a HIPAA covered entity, such as a covered prescriber, to
disclose protected health information (``PHI'') without patient
authorization for ``treatment'' purposes or when ``required by law,''
as well as for other specified purposes.\366\ Providing, confirming, or
correcting a prescription for contact lenses for a contact lens seller
as contemplated under the Contact Lens Rule constitutes ``treatment''
under the HIPAA Privacy Rule.\367\ In addition, to the extent the
disclosure of PHI to provide, confirm, or verify a contact lens
prescription is required under the Act and the Rule, such disclosure
constitutes a disclosure ``required by law'' under the HIPAA Privacy
Rule.\368\ For these reasons, patient authorization is not required for
a prescriber to provide or verify a contact lens prescription with the
contact lens seller, or to provide a contact lens prescription to the
patient.\369\
---------------------------------------------------------------------------
\364\ 69 FR at 40501.
\365\ See 45 CFR 164.502(a)(1); U.S. Dep't of Health & Human
Servs., Office for Civil Rights, ``Summary of the HIPAA Privacy
Rule'' 4-5 (2003), http://www.hhs.gov/sites/default/files/privacysummary.pdf (``A covered entity is permitted . . . to use and
disclose protected health information, without an individual's
authorization, for the following purposes or situations: (1) To the
Individual (unless required for access or accounting of
disclosures); (2) Treatment, Payment, and Health Care Operations;
(3) Opportunity to Agree or Object; (4) Incident to an otherwise
permitted use and disclosure; (5) Public Interest and Benefit
Activities; and (6) Limited Data Set for the purposes of research,
public health or health care operations. Covered entities may rely
on professional ethics and best judgments in deciding which of these
permissive uses and disclosures to make.'') (footnote omitted).
\366\ 69 FR at 40501.
\367\ Id. See also Standards for Privacy of Individually
Identifiable Health Information, 67 FR 53182, 53219 (Aug. 14, 2002).
The U.S. Department of Health & Human Services has explained further
that ``disclosure of protected health information by an eye doctor
to a distributor of contact lenses for the purpose of confirming a
contact lens prescription is a treatment disclosure and is permitted
under the Privacy Rule at 45 CFR 164.506.'' See U.S. Dep't Health &
Human Servs., Health Information Privacy, FAQs, ``Does the HIPAA
Privacy Rule permit an eye doctor to confirm a contact prescription
received by a mail order contact company?,'' http://www.hhs.gov/hipaa/for-professionals/faq/270/does-hipaa-permit-an-eye-doctor-to-confirm-a-contract-prescription-from-a-mail-order-company/index.html.
\368\ See 45 CFR 164.512(a).
\369\ In addition, the HIPAA Privacy Rule right of access
requires a covered prescriber to provide to the patient upon request
or to another person she designates a copy of a prescription. See 45
CFR 164.524(c)(3). See also U.S. Dep't Health & Human Servs., Health
Information Privacy, HIPAA Guidance, ``Individuals' Right under
HIPAA to Access their Health Information,'' http://www.hhs.gov/hipaa/for-professionals/privacy/guidance/access/.
---------------------------------------------------------------------------
In addition to the comments submitted in this rule review, the
Commission has received other questions and complaints related to
prescribers' HIPAA obligations under the Rule. For example, one
prescriber asked whether HIPAA precluded his office from emailing a
copy of a prescription to a patient without written authorization if
the email communication was not encrypted. Correspondingly, some
consumers have complained that their eye care practitioners have
refused to email contact lens prescriptions to them.
As a threshold matter, the Contact Lens Rule itself contemplates
email communication, stating that the prescriber shall ``provide or
verify'' the prescription ``by electronic or other means.'' \370\
Further, the HIPAA Rules do not preclude covered prescribers from
emailing contact lens prescriptions to patients or sellers. According
to guidance provided by the U.S. Department of Health & Human Services,
the HIPAA Rules allow health care providers to communicate
electronically with patients, provided they apply reasonable
safeguards.\371\ Although a covered provider must consider encryption
to protect against unintentional disclosures, the provider may
determine that it is not reasonable and appropriate, and may instead
apply precautions when transmitting unencrypted email, such as checking
the email address for accuracy before sending, sending an email alert
to the intended recipient for address confirmation prior to sending the
message, and limiting the amount and type of PHI transmitted through
the email.\372\
---------------------------------------------------------------------------
\370\ 16 CFR 315.3(a)(2).
\371\ U.S. Dep't Health & Human Servs., Health Information
Privacy, FAQs, ``Does the HIPAA Privacy Rule permit health care
providers to use email to discuss health issues and treatment with
their patients?,'' http://www.hhs.gov/hipaa/for-professionals/faq/570/does-hipaa-permit-health-care-providers-to-use-email-to-discuss-health-issues-with-patients/. See also 45 CFR 164.530(c).
\372\ Encryption of PHI must be implemented where a covered
entity has determined that it is a reasonable and appropriate
safeguard as part of its risk management. See U.S. Dep't Health &
Human Servs., Health Information Privacy, FAQs, ``Is the use of
encryption mandatory in the Security Rule?,'' http://www.hhs.gov/hipaa/for-professionals/faq/2001/is-the-use-of-encryption-mandatory-in-the-security-rule/index.html. A covered health care provider also
must protect PHI in those emails while they are stored on servers,
workstations, mobile devices, and other computer systems, through
encryption and other safeguards, as appropriate. See 45 CFR
164.306(a).
---------------------------------------------------------------------------
Regardless, where an individual requests that the covered entity
transmit PHI by unencrypted email, as is their right under the HIPAA
Privacy Rule right of access, a covered entity must do so.\373\ Before
sending unencrypted email containing PHI to a patient, the entity
should advise the patient of the risk that the unencrypted PHI could be
intercepted and accessed by unauthorized third parties. If, after
having been advised of the risks the patient still prefers to receive
his or her PHI via unencrypted email, the patient has the right to
receive the PHI in that manner and the covered entity is not
responsible for unauthorized access to the PHI during electronic
transmission, nor is the covered entity responsible for safeguarding
the PHI once delivered to the patient.\374\ Conversely, a covered
prescriber also must honor a patient's reasonable request that the
prescriber not send communications via unencrypted email, by offering
other means, such as encrypted email, secure patient portal, postal
mail, or telephone.\375\
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\373\ 45 CFR 164.524(c). See also U.S. Dep't Health & Human
Servs., Health Information Privacy, FAQs, ``Individuals' Right under
HIPAA to Access their Health Information 45 CFR 164.524,'' http://www.hhs.gov/hipaa/for-professionals/privacy/guidance/access/.
\374\ 78 FR 5634 (Jan. 25, 2013).
\375\ 45 CFR 164.522(b).
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D. Enforcement Efforts
In addition to proposing amendments to specific Rule provisions to
further the Rule's goals of competition and patient welfare, several
commenters also urged the Commission to increase its enforcement
efforts and stressed the importance of enforcing the Rule to ensure
that its benefits are realized and
[[Page 88554]]
its risks minimized.\376\ For example, several optometric associations
urged the Commission to enforce the basic patient safeguards outlined
in the Act to protect patients and reduce unnecessary costs.\377\ These
commenters argued that the sale of contact lenses without a valid
prescription increases risks for patients and ultimately leads to
higher health costs, and called for the Commission to take action
against retailers selling lenses without a valid prescription.\378\ The
Coalition for Patient Vision Care Safety asserted that ``noncompliance
with and loopholes within the law have resulted in a deceptive flow of
information to contact lens patients, and have the potential to
compromise seriously the vision health of patients.'' \379\ Many
individual prescribers also urged the Commission generally to increase
enforcement of the Rule.\380\
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\376\ See, e.g., Barr (Comment #639).
\377\ American Optometric Association (Comment #644); Virginia
Optometric Association (Comment #16); Wisconsin Optometric
Association (Comment #30); Utah Optometric Association (Comment
#39); Pennsylvania Optometric Association (Comment #46); Alabama
Optometric Association (Comment #48); Iowa Optometric Association
(Comment #79); Michigan Optometric Association (Comment #86);
California Optometric Association (Comment #119); New Mexico
Optometric Association (Comment #211); Mississippi Optometric
Association (Comment #548); Ohio Optometric Association (Comment
#556); Connecticut Association of Optometrists (Comment #560); North
Carolina State Optometric Society (Comment #567); Tennessee
Association of Optometric Physicians (Comment #575); Colorado
Optometric Association (Comment #584); New Jersey Society of
Optometric Physicians (Comment #595). See also American Academy of
Ophthalmology (Comment #611) (``Wearing improper lenses can further
complicate existing vision issues, including leading to infection in
the eye. The sale of lenses without a prescription is a practice
that continues despite the Rule, and the Academy believes that the
Commission should take swift action to improve enforcement of the
Rule.'').
\378\ Id.
\379\ Comment #621.
\380\ See, e.g., Filandro (Comment #129); Sandler (Comment
#135); Jankowski (Comment #153); Hans (Comment #168); Nguyen
(Comment #175); Robertson (Comment #180); Schumacher (Comment #193);
Sisson (Comment #254); Frederick (Comment #269); Bolenbaker (Comment
#357); Yamamoto (Comment #408); Palmer (Comment #484); Williams
(Comment #494); Marler (Comment #504); Koop (Comment #506); Korth
(Comment #516); Lai (Comment #541); Piersol (Comment #571). See also
Senator Perdue (Comment #569).
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On the other hand, online retailers such as 1-800 CONTACTS and
Warby Parker recommended increased enforcement efforts against non-
compliant prescribers, particularly with respect to the automatic
release of prescriptions.\381\ These commenters complained that despite
``the widespread refusal of prescribers to release prescriptions,''
Commission action against prescribers has been limited to a handful of
warning letters.\382\ These commenters proposed that the Commission
amend Section 315.9 of the Rule, the enforcement provision, to add
language to clarify that any violation of the Rule--by either sellers
or prescribers--constitutes a violation of a rule under Section 18 of
the Federal Trade Commission Act, subject to the same fines and
penalties as any other violation of the Act.\383\
---------------------------------------------------------------------------
\381\ 1-800 CONTACTS (Comment #568); Warby Parker (Comment
#593).
\382\ Id.
\383\ 5 U.S.C. 57a.
---------------------------------------------------------------------------
With respect to commenters' recommendations that the Commission
increase its enforcement efforts, the Commission notes that the rule
review process has been instrumental in identifying areas that need
further investigation. Accordingly, the Commission will consider ways
to leverage its enforcement, consumer education,\384\ and business
guidance efforts to address the concerns identified.\385\ However, the
Commission does not believe it necessary to amend Section 315.9 of the
Rule to clarify that violations by either sellers or prescribers
constitute a violation of the Rule under Section 18 of the Federal
Trade Commission Act. The language of the Act and Rule are clear on
this point.\386\
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\384\ The state optometric associations also encouraged the
Commission to do more to ``ensure that patients are aware that
contact lenses are regulated medical devices, whose safe use and
optimal performance depends on eye examinations and professional
supervision.'' Virginia Optometric Association (Comment #16);
Wisconsin Optometric Association (Comment #30); Utah Optometric
Association (Comment #39); Pennsylvania Optometric Association
(Comment #46); Alabama Optometric Association (Comment #48); Iowa
Optometric Association (Comment #79); Michigan Optometric
Association (Comment #86); California Optometric Association
(Comment #119); New Mexico Optometric Association (Comment #211);
Mississippi Optometric Association (Comment #548); Ohio Optometric
Association (Comment #556); Connecticut Association of Optometrists
(Comment #560); North Carolina State Optometric Society (Comment
#567); Tennessee Association of Optometric Physicians (Comment
#575); Colorado Optometric Association (Comment #584); New Jersey
Society of Optometric Physicians (Comment #595).
\385\ Furthermore, the Commission believes that the proposed
Rule amendment requiring a signed acknowledgment of receipt of a
contact lens prescription will also aid Rule enforcement efforts.
See supra Section III.A.3.
\386\ See 15 U.S.C. 7608; 16 CFR 315.9.
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E. Recommendations Regarding the Commission's Complaint Reporting
System
The Commission received a variety of comments suggesting proposals
to improve perceived shortcomings in the agency's complaint reporting
system to aid Rule enforcement efforts. Several optometric
associations, for example, expressed their opinion that the
Commission's consumer reporting process is not adequately designed to
deal with contact lens complaints, and recommended that the Commission
``develop a distinct complaint submission process for contact lens-
related concerns.'' \387\ More specifically, the American Optometric
Association asserted that the online complaint assistant service is not
appropriately set up to receive these types of complaints, and doctors
who report issues of concern often feel their reports go
unnoticed.\388\ This commenter stated that setting up a distinct
Contact Lens Rule complaint system would benefit patients as well,
providing them with a simple process to follow in case they have
contact lens sale-related concerns.\389\ Likewise, the Coalition for
Patient Vision Care Safety was troubled that the agency ``routes eye
contact complaints about non-compliance to its general complaint
lines'' and asserted that the general routing of complaints discourages
the reporting of complaints and fails to provide the Commission with
adequate and accessible information to enforce the Rule.\390\ The
Coalition recommended that the Commission instead utilize dedicated
personnel paired with a dedicated Web site or phone number within the
Commission.\391\
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\387\ American Optometric Association (Comment #644); Virginia
Optometric Association (Comment #16); Wisconsin Optometric
Association (Comment #30); Utah Optometric Association (Comment
#39); Pennsylvania Optometric Association (Comment #46); Alabama
Optometric Association (Comment #48); Iowa Optometric Association
(Comment #79); Michigan Optometric Association (Comment #86);
California Optometric Association (Comment #119); New Mexico
Optometric Association (Comment #211); Mississippi Optometric
Association (Comment #548); Ohio Optometric Association (Comment
#556); Connecticut Association of Optometrists (Comment #560); North
Carolina State Optometric Society (Comment #567); Tennessee
Association of Optometric Physicians (Comment #575); Colorado
Optometric Association (Comment #584); New Jersey Society of
Optometric Physicians (Comment #595).
\388\ Comment #644.
\389\ Id.
\390\ Comment #621.
\391\ Id.
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Other commenters expressed doubts that the complaint reporting
system was adequate to capture specific types of complaints. For
example, two State representatives, Rhode Island State Rep. Brian
Patrick Kennedy and Arizona State Rep. Heather Carter, asserted that
the current system favors eye care providers and their ability to file
complaints against resellers of contact lenses.\392\ These commenters
recommended that the Commission consider simplifying the complaint
process to make it easier for consumers
[[Page 88555]]
to file complaints against their eye care provider, as well as
replacement contact lens resellers. Likewise, some online retailers
recommended that to facilitate enforcement efforts the Commission
should ``create a user-friendly online complaint process for
consumers.'' \393\ These commenters argued that the online complaint
assistant is difficult to navigate and does not ask the appropriate
questions to identify a Rule violation.\394\
---------------------------------------------------------------------------
\392\ Comments ##536, 545.
\393\ 1-800 CONTACTS (Comment #568); Warby Parker (Comment
#593). See also LD Vision Group (Comment #544) (recommending that
the Commission ``[c]reate an online reporting mechanism for sellers
and consumers to report unfair prescriber practices'').
\394\ 1-800 CONTACTS (Comment #568); Warby Parker (Comment
#593).
---------------------------------------------------------------------------
After careful consideration of these comments, the Commission
declines to redesign its complaint reporting mechanism. The Commission
has designed the FTC Complaint Assistant, the agency's online complaint
reporting system, to be responsive to consumers who wish to file
complaints about more than a hundred different types of products or
services, while at the same time facilitating the filing of complaints
regarding the most common complaint areas. Accordingly, the home page
of the complaint system contains primary links for the FTC's seven most
common complaint areas. The Commission's goal is that the primary links
on the home page be responsive to at least 80 percent of the consumer
complaints the agency receives. Although highlighting the most frequent
types of complaints necessarily means that many areas of concern cannot
be listed as separate categories, users can easily submit their
complaint under the category ``Other'' when there is no listed category
for the complaint, as is the case with contact lenses. Once the
``Other'' category is selected, the subsequent Web page includes the
``Health and Fitness'' subcategory, which is described as including,
``prescriptions, eye care.'' After screening out complaints related to
telemarketing phone calls and spam email, the first option on the
following Web page asks whether the complaint relates to ``Eyeglasses
or Contact Lenses.'' During this process, the person lodging the
complaint is given ample room to describe the details of the complaint.
Instructions on the FTC Complaint Assistant page explain that the
FTC will categorize a complaint even if it does not fit one of the
listed categories. In addition, the Web page also informs users that if
they are ``having trouble categorizing [their] complaint,'' they can
chat online with FTC tech support. Accordingly, the Commission believes
that the FTC Complaint Assistant is configured to capture and report
all contact lens-related complaints, whether they originate from
consumers, prescribers, sellers, or others. However, resources
permitting, the Commission will explore whether a dedicated email
address would also be beneficial to complement the Complaint Assistant.
VI. Request for Comment
You can file a comment online or on paper. For the Commission to
consider your comment, we must receive it on or before January 30,
2017. Write ``Contact Lens Rule, 16 CFR part 315, Project No. R511995''
on the comment. Your comment, including your name and your state, will
be placed on the public record of this proceeding, including, to the
extent practicable, on the public Commission Web site, at http://www.ftc.gov/os/publiccomments.shtm. As a matter of discretion, the
Commission tries to remove individuals' home contact information from
comments before placing them on the Commission Web site. Because your
comment will be made public, you are solely responsible for making sure
that your comment does not include any sensitive personal information,
such as a Social Security number, date of birth, driver's license
number or other state identification number or foreign country
equivalent, passport number, financial account number, or credit or
debit card number. You are also solely responsible for making sure that
your comment does not include any sensitive health information, such as
medical records or other individually identifiable health information.
In addition, do not include any ``[t]rade secret or any commercial or
financial information which is . . . privileged or confidential,'' as
discussed in Section 6(f) of the FTC Act, 15 U.S.C. 46(f), and FTC Rule
4.10(a)(2), 16 CFR 4.10(a)(2). In particular, do not include
competitively sensitive information such as costs, sales statistics,
inventories, formulas, patterns, devices, manufacturing processes, or
customer names.
If you want the Commission to give your comment confidential
treatment, you must file it in paper form, with a request for
confidential treatment, and you must follow the procedure explained in
FTC Rule 4.9(c), 16 CFR 4.9(c). In particular, the written request for
confidential treatment that accompanies the comment must include the
factual and legal basis for the request, and must identify the specific
portions of the comments to be withheld from the public record. Your
comment will be kept confidential only if the FTC General Counsel
grants your request in accordance with the law and the public interest.
Postal mail addressed to the Commission is subject to delay due to
heightened security screening. As a result, we encourage you to submit
your comment online. To make sure that the Commission considers your
online comment, you must file it at https://ftcpublic.commentworks.com/ftc/contactlensrule by following the instructions on the web-based
form. If this Notice appears at http://www.regulations.gov/#!home. you
also may file a comment through that Web site.
If you file your comment on paper, write ``Contact Lens Rule, 16
CFR Part 315, Project No. R511995'' 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, or deliver your comment to the
following address: Federal Trade Commission, Office of the Secretary,
Constitution Center, 400 7th Street SW., 5th Floor, Suite 5610 (Annex
C), Washington, DC 20024.
Visit the Commission Web site at http://www.ftc.gov to read this
Notice and the news release describing it. The FTC Act and other laws
that the Commission administers permit the collection of public
comments to consider and use in this proceeding as appropriate. The
Commission will consider all timely and responsive public comments that
it receives on or before January 30, 2017. For information on the
Commission's privacy policy, including routine uses permitted by the
Privacy Act, see http://www.ftc.gov/ftc/privacy.htm.
The Commission invites members of the public to comment on any
issues or concerns they believe are relevant or appropriate to the
Commission's consideration of proposed amendments to the Rule. The
Commission requests you provide factual data, and in particular,
empirical data, upon which your comments are based. In addition to the
issues raised above, the Commission solicits public comment on the
costs and benefits to industry members and consumers of each of the
proposals as well as the specific questions identified below. These
questions are designed to assist the public and should not be construed
as a limitation on the issues on which public comment may be submitted.
Questions
A. General Questions on Proposed Amendments: To maximize the
benefits
[[Page 88556]]
and minimize the costs for prescribers and sellers (including small
businesses), the Commission seeks views and data on the following
general questions for each of the proposed changes described in this
NPRM:
1. What benefits would a proposed change confer and on whom? The
Commission in particular seeks information on any benefits a change
would confer on consumers of contact lenses.
2. What costs or burdens would a proposed change impose and on
whom? The Commission in particular seeks information on any burdens a
change would impose on small businesses.
3. What regulatory alternatives to the proposed changes are
available that would reduce the burdens of the proposed changes while
providing the same benefits?
4. What additional information, tools, or guidance might the
Commission provide to assist industry in meeting extant or proposed
requirements efficiently?
5. What evidence supports your answers?
B. Acknowledgment of prescription release:
1. Would the proposed amendment to require prescribers, after the
completion of a contact lens fitting, to request the contact lens
patient acknowledge receipt of the contact lens prescription by signing
an acknowledgment form increase, decrease, or have no effect on
compliance with the Rule's requirement that patients receive a copy of
their contact lens prescription after the completion of the contact
lens fitting? Why?
2. Would the proposed amendment to require prescribers to maintain
copies of the signed acknowledgments for a period of not less than
three years increase, decrease, or have no effect on the Commission's
ability to measure and enforce the Rule's automatic prescription
release provision? Why?
3. Would the proposed amendment to require the acknowledgment form
to inform patients that they may purchase contact lenses from the
seller of their choice increase, decrease, or have no effect on the
extent to which patients understand their rights under the Rule? Why?
4. Should the Commission consider other language to be included in
the signed acknowledgment form? If so, what?
5. Would allowing the acknowledgment form to be in either paper or
electronic format increase, decrease, or have no effect on the extent
to which patients understand their rights under the Rule? What other
factors should the Commission consider to lower the cost and improve
the reliability of executing, storing, and retrieving the signed
acknowledgment forms?
6. Should the proposed amendment contain specific language about
the use of electronic acknowledgment forms and electronic signatures?
If so, what? Should the proposed amendment contain particular
requirements about the type of electronic acknowledgment forms and
electronic signatures to be used? If so, what types should be required?
7. Are there alternate ways to structure a patient acknowledgment
requirement that would reduce the burdens of the proposed amendment
while providing the same, or greater, benefits?
8. What evidence supports your answers?
C. Additional mechanisms for improving prescription portability:
1. The Commission believes that the use of patient portals to
provide patients with access to electronic copies of their
prescriptions would benefit prescribers, sellers, and patients. The
Commission seeks comment on the benefits or burdens that the use of
patient portals would confer.
2. The Commission seeks comment on the level of adoption of patient
portals. Do prescribers use patient portals? Do patients use them? What
are the rates of patient adoption when prescribers make them available?
3. What characteristics should patient portals have in order to
best promote prescription portability?
4. Do patient portals have the potential to allow prescribers to
comply with the automatic prescription release requirements of the
Rule? If so, how? Do patient portals have limitations that would
prevent them from being used by prescribers to comply with the
automatic prescription release requirements of the Rule? If so, what
are they?
5. If the Commission were to determine that patient portals could
be used to comply with the automatic prescription release requirements
of the Rule, how would this determination affect the requirement that
prescribers obtain a signed acknowledgment form from patients? Do
patient portals have characteristics that could serve as a substitute
for the signed acknowledgment form?
6. What other technologies are available that could be implemented
to improve prescription portability and thereby increase benefits and
decrease burdens related to prescription release?
7. What evidence supports your answers?
D. Additional copies of prescriptions:
1. In this NPRM, the Commission has preliminarily determined that
requiring prescribers to provide additional copies of contact lens
prescriptions to a patient upon request is required by the Act. How
does this determination affect, if at all, the portability of contact
lens prescriptions?
2. Does this determination affect the accuracy of contact lens
prescriptions presented to sellers? If so, how?
3. Does this determination affect the administrative burden of
prescribers? If so, how? Would any burden caused by this determination
be offset by a reduced burden related to prescription verification
requests? If so, how?
4. What evidence supports your answers?
E. Sellers designated to act on behalf of patients:
1. Should the Commission impose a timeframe for prescribers, under
Section 315.3(a)(2) of the Rule, to respond to requests from authorized
third parties for a copy of a patient's prescription?
2. If so, what would be the appropriate amount of time for a
prescriber to be required to respond to a request from an authorized
third party for a copy of a patient's prescription?
3. What evidence supports your answers?
F. Presentation of prescription ``directly or by facsimile'' under
Section 315.5(a)(1):
1. The Commission has initially determined that presenting a
prescription to a seller ``directly or by facsimile'' includes the use
of online patient portals. Does this determination further the Act's
goal of prescription portability? If so, how?
2. What is the impact, including costs and benefits, of this
determination?
3. What evidence supports your answers?
G. Automated telephone systems as ``direct communication'' under
Section 315.5(a)(2):
1. What modifications to automated telephone calls, short of
prohibiting the use of such calls, should the Commission consider to
address the concerns raised by prescribers about the burden of such
calls?
H. Section 315.5(e)--No alteration of prescription provision:
1. To conform the language of the Rule to the language of the Act,
the Commission proposes to amend Section 315.5(e) to strike the words
``private label.'' Would this proposed amendment alter the way that
prescribers, sellers, or manufacturers do business, and if so, how?
[[Page 88557]]
2. Are there alternative proposals that the Commission should
consider?
3. What evidence supports your answers?
VII. Communications by Outside Parties to the Commissioners or Their
Advisors
Written communications and summaries or transcripts of oral
communications respecting the merits of this proceeding, from any
outside party to any Commissioner or Commissioner's advisor, will be
placed on the public record. See 16 CFR 1.26(b)(5).
VIII. Paperwork Reduction Act
The existing Rule contains recordkeeping and disclosure
requirements that constitute ``information collection requirements'' as
defined by 5 CFR 1320.3(c) under Office of Management and Budget
(``OMB'') regulations that implement the Paperwork Reduction Act
(``PRA''), 44 U.S.C. 3501 et seq. OMB has approved the Rule's existing
information collection requirements. (OMB Control No. 3084-0127).
The proposed modifications to the Rule would require that
prescribers obtain from patients, and maintain for a period of not less
than three years, a signed acknowledgment form, entitled ``Patient
Receipt of Contact Lens Prescription,'' confirming that patients
received their contact lens prescriptions at the completion of their
contact lens fitting. The proposed recordkeeping requirement would
constitute an information collection as defined by 5 CFR 1320.3(c).
Accordingly, the Commission is providing PRA burden estimates for them,
as set forth below. The Commission will also submit this notice of
proposed rulemaking and associated Supporting Statement to OMB for
review under the PRA. The proposed requirement that prescribers provide
an acknowledgment form to patients, however, does not constitute an
information collection under the PRA, in that the Rule specifies the
language that the form must contain.\395\
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\395\ The public disclosure of information originally supplied
by the Federal government to the recipient for the purpose of
disclosure to the public is not a ``collection of information.'' 5
CFR 1320.3(c)(2).
---------------------------------------------------------------------------
A. Estimated Additional Hours Burden
Commission staff estimates the paperwork burden of the proposed
modifications based on its knowledge of the eye care industry. The
staff believes there will be an additional burden on individual
prescribers' offices to maintain the signed acknowledgment forms for a
period of not less than three years.
The number of contact lens wearers in the United States is
currently estimated to be approximately 41 million.\396\ Therefore,
assuming an annual contact lens exam for each contact lens wearer,
approximately 41 million people would read and sign an acknowledgment
form every year.\397\
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\396\ Cope, supra note 29, at 866.
\397\ In the past, some commenters have suggested that typical
contact lens wearers obtain annual exams every 18 months or so,
rather than one every year. However, because most prescriptions are
valid for a minimum of one year under the Rule, and use of a longer
exam cycle would lead to an estimate of a lower number of signed
acknowledgment forms and a reduced burden, we continue to estimate
that patients seek exams every 12 months.
---------------------------------------------------------------------------
Maintaining the form for a period of not less than three years does
not impose a substantial new burden on individual prescribers and their
office staff. The majority of states already require that optometrists
maintain records of eye examinations for at least three years,\398\ and
maintaining a one-page acknowledgment form per patient per year should
not take more than a few seconds of time, and an inconsequential, or de
minimis, amount of record space. Some prescribers might present the
acknowledgment form electronically, and such format would allow the
signed acknowledgment to be preserved without any additional burden.
For other prescribers, the new recordkeeping requirement would likely
require that office staff either preserve the signed acknowledgment
form in paper format or electronically scan the signed acknowledgment
form and save it as an electronic document. In the latter scenario, the
Commission estimates this scanning and saving would take approximately
one minute. The Commission does not possess any information regarding
the percentage of prescribers' offices that use paper forms, electronic
forms, or that scan paper files and maintain them electronically.
Therefore, for purposes of this notice, staff will assume that all
prescriber offices require a full one minute per form per year for
record maintenance purposes arising from the proposed modifications.
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\398\ See, e.g., 246 Mass. Code Regs. Sec. 3.02 (requiring
optometrists to maintain patient records for at least seven years);
Wash. Admin. Code Sec. 246-851-290 (requiring optometrists to
maintain records of eye exams and prescriptions for at least five
years); Iowa Admin. Code r. 645-182.2(2) (requiring optometrists to
maintain patient records for at least five years); Fla. Admin. Code
r. 64B13-3.003(6) (requiring optometrists to maintain patient
records for at least five years).
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As noted above, the number of contact lens wearers in the United
States is currently estimated to be approximately 41 million.
Therefore, assuming one signed acknowledgment form for each contact
lens wearer per year, prescribers' offices, collectively, would have to
spend approximately 41 million minutes, or 683,333 hours, per year
maintaining records of eye examinations (recordkeeping requirement).
In all likelihood, the actual overall increased burden on
prescribers may be less than 683,333 hours, because increasing the
number of patients in possession of their prescriptions should
correspondingly increase the number of consumers who provide their
prescriptions to third-party sellers when purchasing contact lenses.
This, in turn, should reduce the number of verification requests that
third-party sellers would otherwise make to prescribers. Based on
current estimates, responding to verification requests requires that
prescribers spend approximately five minutes per request.\399\ The
Commission, however, does not presently have enough information to
devise a reliable estimate for how many more consumers are likely to
present third-party sellers with a complete copy of their prescription
following the proposed Rule modification. Therefore, for purposes of
calculating the burden, the Commission, at this time, will not credit
the expected reduction in verification burden.
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\399\ See American Optometric Association, Comment in response
to the Agency Information Collection Activities; Proposed
Collection; Comment Request, 81 FR 31938 (May 20, 2016), https://www.ftc.gov/policy/public-comments/initiative-665.
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B. Estimated Total Labor Cost Burden
Commission staff derives labor costs by applying appropriate hourly
cost figures to the burden hours described above. The Commission
assumes that office clerks will perform most of the labor when it comes
to printing, disseminating, and storing the acknowledgment forms for
prescribers' offices. According to Bureau of Labor Statistics, general
office clerks earn an average wage of $15.33 per hour.\400\ Based on
this data, the estimated total additional labor cost attributable to
the proposed modifications to the Rule would amount to approximately
$10,475,495.
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\400\ Press Release, U.S. Dep't of Labor, Bureau of Labor
Statistics, ``Occupational Employment Statistics--May 2015,'' http://www.bls.gov/news.release/ocwage.t01.htm.
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While not insubstantial, this amount constitutes just under one-
fourth of one percent of the estimated overall retail market for
contact lens sales in the
[[Page 88558]]
United States.\401\ Furthermore, the burden is likely to be less,
because many prescribers' offices will not require a full minute to
store the acknowledgment form. And, as noted above, increasing the
number of patients in possession of their prescriptions should
correspondingly increase the number of consumers who provide their
prescriptions to third-party sellers when purchasing contact lenses.
This, in turn, could potentially reduce the number of verification
requests made to prescribers, and the time prescribers spend
responding.
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\401\ According to The Vision Council, the contact lens sales
market in the United States in 2015 totaled $4,664,200,000 at the
retail level. See The Vision Council, ``U.S. Optical Industry Report
Card,'' Dec. 2015. The estimated additional burden of $10,475,495
thus amounts to approximately 0.22% of the total market.
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The Commission invites comments on: (1) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information shall
have practical utility; (2) the accuracy of the FTC's burden estimates,
including whether the methodology and assumptions used are valid; (3)
ways to enhance the quality, utility, and clarity of the information to
be collected; and (4) ways to minimize the burden of collecting
information.
Comments on the information collection requirements subject to
review under the PRA should also be submitted to Office of Management
and Budget. If sent by U.S. mail, address comments to: Office of
Information and Regulatory Affairs, Office of Management and Budget,
Attention: Desk Officer for the Federal Trade Commission, New Executive
Office Building, Docket Library, Room 10102, 725 17th Street NW.,
Washington, DC 20503. Comments sent to OMB by U.S. postal mail,
however, are subject to delays due to heightened security precautions.
Thus, comments instead should be sent by facsimile to (202) 395-5167.
IX. Regulatory Flexibility Act
The Regulatory Flexibility Act (``RFA'') \402\ requires the
Commission to conduct an analysis of the anticipated economic impact of
the proposed amendments on small entities.\403\ The purpose of a
regulatory flexibility analysis is to ensure the agency considers the
impacts on small entities and examines regulatory alternatives that
could achieve the regulatory purpose while minimizing burdens on small
entities. Section 605 of the RFA \404\ provides that such an analysis
is not required if the agency head certifies that the regulatory action
will not have a significant economic impact on a substantial number of
small entities.
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\402\ 5 U.S.C. 601-612.
\403\ The Commission also conducted an RFA analysis of prior
amendments to the Rule implementing the Fairness to Contact Lens
Consumers Act. 69 FR 40482, 40507 (July 2, 2004).
\404\ 5 U.S.C. 605.
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The Commission does not anticipate that the proposed amendments
will have a significant economic impact on small entities, although
they may affect a substantial number of small businesses. The proposed
amendments require that prescribers obtain from patients, and maintain
for a period of not less than three years, a signed acknowledgment
form, entitled ``Patient Receipt of Contact Lens Prescription,''
confirming that patients received their contact lens prescriptions at
the completion of their contact lens fitting. The Commission believes
the burden of complying with this requirement likely will be relatively
small. As discussed in the Paperwork Reduction Act section, the
majority of states already require that optometrists maintain records
of eye examinations for at least three years. The proposed amendment
would require one additional page to be maintained as a record, which
is likely a minimal burden. Therefore, based on available information,
the Commission certifies that amending the Rule as proposed will not
have a significant economic impact on a substantial number of small
businesses.
Although the Commission certifies under the RFA that the proposed
amendment will not, if promulgated, have a significant impact on a
substantial number of small entities, the Commission has nonetheless
determined it is appropriate to publish an Initial Regulatory
Flexibility Analysis to inquire into the impact of the proposed
amendment on small entities. Therefore, the Commission has prepared the
following analysis:
A. Description of the Reasons the Agency Is Taking Action
In response to public comments, the Commission proposes amending
the Rule to ensure that patients are receiving a copy of their contact
lens prescription at the completion of a contact lens fitting.
B. Statement of the Objectives of, and Legal Basis for, the Proposed
Amendments
The objective of the proposed amendment is to clarify and update
the Rule in accordance with marketplace practices. The legal basis for
the Rule is the Fairness to Contact Lens Consumers Act.\405\ The Act
authorizes the Commission to implement its requirements through the
issuance of rules.
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\405\ 15 U.S.C. 7601-7610.
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C. Small Entities to Which the Proposed Amendments Will Apply
The proposed amendments apply to prescribers of contact lenses. The
Commission believes that many prescribers will fall into the category
of small entities (e.g., offices of optometrists less than $7.5 million
in size).\406\ Determining a precise estimate of the number of small
entities covered by the Rule's prescription release requirements is not
readily feasible because most prescribers' offices do not release the
underlying revenue information necessary to make this
determination.\407\ Based on its knowledge of the eye care industry,
staff believes that a substantial number of these entities likely
qualify as small businesses. The Commission seeks comment with regard
to the estimated number or nature of small business entities, if any,
for which the proposed amendments would have a significant impact.
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\406\ See U.S. Small Business Admin., ``Table of Small Business
Size Standards Matched to North American Industry Classification
System Codes,'' (eff. Feb. 26, 2016), https://www.sba.gov/sites/default/files/files/Size_Standards_Table.pdf.
\407\ 5 U.S.C. 601(6).
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D. Projected Reporting, Recordkeeping, and Other Compliance
Requirements, Including Classes of Covered Small Entities and
Professional Skills Needed To Comply
As explained earlier in this document, the proposed amendments
require that prescribers obtain from patients, and maintain for a
period of not less than three years, a signed acknowledgment form,
entitled ``Patient Receipt of Contact Lens Prescription,'' confirming
that patients received their contact lens prescriptions at the
completion of their contact lens fitting.
The small entities potentially covered by these proposed amendments
will include all such entities subject to the Rule. The professional
skills necessary for compliance with the Rule as modified by the
proposed amendments will include office and administrative support
supervisors to create the acknowledgment form and clerical personnel to
collect signatures from patients and maintain records. The Commission
believes the burden imposed on small businesses by these requirements
is relatively small, for the reasons described previously in Section
[[Page 88559]]
VIII of this notice. The Commission invites comment and information on
these issues, including estimates or data on specific compliance costs
that small entities might be expected to incur.
E. Duplicative, Overlapping, or Conflicting Federal Rules
The Commission has not identified any other federal statutes,
rules, or policies duplicating, overlapping, or conflicting with the
proposed amendments, but as noted previously, the majority of states
already require that optometrists--of which many are most likely small
businesses--maintain records of eye examinations for at least three
years. The Commission invites additional comment on this issue.
F. Significant Alternatives to the Proposed Amendments
The Commission has not proposed any specific small entity exemption
or other significant alternatives, as the proposed amendments clarify
and update the Rule in light of marketplace practices to ensure that
patients are receiving a copy of their contact lens prescription at the
completion of a contact lens fitting. Under these limited
circumstances, the Commission does not believe a special exemption for
small entities or significant compliance alternatives are necessary or
appropriate to minimize the compliance burden, if any, on small
entities while achieving the intended purposes of the proposed
amendments. As discussed above, the proposed recordkeeping requirement
likely involves minimal burden and prescribers would be permitted to
maintain records in either paper or electronic format. This
recordkeeping burden could be reduced to the extent that prescribers
have adopted electronic medical record systems, especially those where
patient signatures can be recorded electronically and input
automatically into the electronic record. Furthermore, prescribers also
could scan signed paper copies of the acknowledgment form and store
those forms electronically to lower the costs of this recordkeeping
requirement. Nonetheless, the Commission seeks comment on the need, if
any, for alternative compliance methods to reduce the economic impact
of the Rule on small entities. If the comments filed in response to
this NPRM identify small entities affected by the proposed amendments,
as well as alternative methods of compliance that would reduce the
economic impact of the proposed amendments on such entities, the
Commission will consider the feasibility of such alternatives and
determine whether they should be incorporated into the final Rule.
X. Proposed Rule Language
List of Subjects in 16 CFR Part 315
Advertising, Medical devices, Ophthalmic goods and services, Trade
practices.
Under 15 U.S.C 7601-7610 and as discussed in the preamble, the
Federal Trade Commission proposes to amend title 16 of the Code of
Federal Regulations by revising part 315 as follows:
PART 315--CONTACT LENS RULE
0
1. The authority citation for part 315 continues to read as follows:
Authority: Pub. L. 108-164, secs. 1-12; 117 Stat. 2024 (15
U.S.C. 7601-7610).
0
2. Amend Sec. 315.3 by adding paragraph (c) to read as follows:
Sec. 315.3 Availability of contact lens prescriptions to patients.
* * * * *
(c) Acknowledgment of prescription release. Upon completion of a
contact lens fitting, and after providing a copy of the contact lens
prescription to the patient, the prescriber:
(1) Shall request that the contact lens patient acknowledge receipt
of the contact lens prescription by signing an acknowledgment form
entitled, ``Patient Receipt of Contact Lens Prescription'' that states,
``My eye care professional provided me with a copy of my contact lens
prescription at the completion of my contact lens fitting. I understand
I am free to purchase contact lenses from the seller of my choice.''
(2) The acknowledgment form shall include, in addition to the title
and statement specified in paragraph (c)(1), the name of the patient,
the patient signature, and the date executed. In the event that the
patient declines to sign the acknowledgment form, the prescriber shall
note the patient's refusal on the form and sign it. No other statements
or information, other than the address or letterhead of the prescriber,
shall be placed on the acknowledgment form.
(3) The prescriber shall maintain the signed acknowledgments
received under paragraph (c)(1) for a period of not less than three (3)
years, and such signed acknowledgments shall be available for
inspection by the Federal Trade Commission, its employees, and its
representatives.
0
3. Amend Sec. 315.5 paragraph (e) by revising the second sentence to
read as follows:
Sec. 315.5 Prescriber verification.
* * * * *
(e) * * * Notwithstanding the preceding sentence, a seller may
substitute for contact lenses specified on a prescription identical
contact lenses that the same company manufactures and sells under
different labels.
* * * * *
By direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. 2016-28471 Filed 12-6-16; 8:45 am]
BILLING CODE 6750-01-P