Contact Lens Rule
| Published date | 17 August 2020 |
| Citation | 85 FR 50668 |
| Pages | 50668-50718 |
| FR Document | 2020-14206 |
| Section | Rules and Regulations |
| Issuer | Federal Trade Commission |
Federal Register, Volume 85 Issue 159 (Monday, August 17, 2020)
[Federal Register Volume 85, Number 159 (Monday, August 17, 2020)]
[Rules and Regulations]
[Pages 50668-50718]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-14206]
[[Page 50667]]
Vol. 85
Monday,
No. 159
August 17, 2020
Part III
Federal Trade Commission
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16 CFR Part 315
Contact Lens Rule; Final Rule
Federal Register / Vol. 85, No. 159 / Monday, August 17, 2020 / Rules
and Regulations
[[Page 50668]]
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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: Final rule.
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SUMMARY: The FTC is publishing a final rule to implement amendments to
the Contact Lens Rule. These amendments require that prescribing eye
care practitioners obtain a confirmation of prescription release from
patients after releasing a contact lens prescription and maintain each
such acknowledgment for a period of not less than three years. The
Commission is permitting prescribers to comply with automatic
prescription release via electronic delivery in certain circumstances.
Further, these amendments specify a time period for prescribers to
respond to requests for prescriptions; clarify and institute additional
requirements for automated telephone verification messages; more
precisely delineate what constitutes unlawful alteration of a
prescription; and require that sellers provide a method for, and notice
of the method for, patient prescription presentation.
DATES: This rule is effective October 16, 2020.
ADDRESSES: Relevant portions of the record of this proceeding,
including this document, are available at https://www.ftc.gov.
FOR FURTHER INFORMATION CONTACT: Alysa Bernstein (202-326-3289),
[email protected], Paul Spelman (202-326-2487), [email protected], or
Andrew Wone (202-326-2934), [email protected], 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. History of the Rule C. Initial Request for Comments in 2015 D. Notice of Proposed Rulemaking in 2016 E. Supplemental Notice of Proposed Rulemaking
II. Final Rule Pertaining to Confirmation of Prescription Release A. Proposed Modifications in the SNPRM B. Basis for SNPRM Confirmation of Prescription Release Proposal C. Comments on the Confirmation of Prescription Release Proposal
and the Basis for Such Proposal 1. Comments About the Need for the Confirmation of Prescription
Release and Whether Prescribers Are Complying With the Rule's
Automatic Prescription Release Requirement a. Survey Evidence as Proof of Non-Compliance b. Lack of Consumer Complaints as Evidence of Compliance c. Number of Verifications as Evidence of Non-Compliance With
the Automatic Prescription Release Requirement 2. Comments About the Need To Improve the Commission's Ability
To Monitor Compliance and Enforce the Rule 3. Comments About Whether the Structure of the Contact Lens
Market Creates a Need for Verifiable Enforcement of Automatic
Prescription Release 4. Comments About the Text of the Proposed Confirmation of
Prescription and the Option To Include the Confirmation as Part of a
Patient's Prescription or Sales Receipt 5. Comments About Option (D) and Using Electronic Delivery for
Confirmation of Prescription Release a. Use of Patient Portals and Patient Consent b. Requirement To Maintain Records of Patient Consent 6. Comments About Alternatives to the Confirmation of
Prescription Release a. Signage b. Educational Programs as an Alternative to Confirmation of
Prescription Release 7. Comments About the Burden and Benefits of the Confirmation of
Prescription Release Proposal 8. Comments About the Exemption for Prescribers Who Do Not Have
a Direct or Indirect Financial Interest in the Sale of Contact
Lenses D. Additional Discussion and Commission Determination Regarding
the Confirmation of Prescription Release Proposal
III. Additional Requirements for Sellers Using Verification Calls
Containing Automated Messages A. The Congressional Record Does Not Support Prohibiting
Automated Telephone Messages B. Comments About, and Adoption of, Requirements Proposed in the
SNPRM To Improve Quality of Automated Telephone Messages C. The Commission's Proposal Requiring Sellers To Record
Automated Telephone Messages D. The Final Rule Does Not Adopt Commenters' Additional
Recommendations Regarding Automated Telephone Messages
IV. Prescribers' Selection of Communication Mechanism
V. Miscellaneous Passive Verification Issues A. Active Verification Is Not Required B. Concerns About Patient Manipulation C. Eight-Business-Hour Time Frame Is Appropriate
VI. Seller Alteration of Contact Lens Prescriptions and Private
Label Concerns A. The Final Rule Includes a Requirement for Sellers To Accept
Prescription Presentation B. Alteration Includes a Seller Providing a Prescriber With a
Verification Request for a Non-Prescribed Manufacturer or Brand, but
Includes an Exception for Verifying a Manufacturer or Brand That a
Consumer Indicates Is on Her Prescription 1. The Final Rule Modifications Regarding Alteration Are
Beneficial and Address Abuses of the Verification System 2. Comments Related to the Exception to Alteration When a Seller
Provides the Manufacturer or Brand of Lenses That a Consumer
Provides in Response to a Seller's Request for That Information 3. Comments Regarding and Commission Guidance on Acceptable
Methods for Obtaining the Brand or Manufacturer Listed on Consumers'
Prescriptions 4. The Commission Is Not Imposing a Recordkeeping Requirement
for Sellers Related to the Exception C. Private Label Issues 1. The Commission Adopts a Technical Amendment and Clarifies
That the Only Permissible Substitution Involves Private Label Lenses 2. The Commission Is Not Imposing Additional Requirements on
Prescriptions for Private Label Lenses
VII. ``Directly or by Facsimile'' Language Includes Use of Online
Patient Portals to Present Prescriptions
VIII. Requests for an Additional Copy of a Prescription A. Benefits of an Additional Copy and the Time Period To Respond
to a Request B. Requirement To Maintain Records
IX. Excessive Quantity
X. Expiration of Contact Lens Prescriptions A. Length of Contact Lens Prescriptions B. Sales Using Expired Contact Lens Prescriptions
XI. Paperwork Reduction Act A. Confirmation of Prescription Release and Affirmative Consent
to Digital Delivery of a Prescription 1. SNPRM Burden Estimate for the Confirmation of Prescription
Release 2. Comments Regarding the SNPRM Estimate for the Confirmation of
Prescription Release Requirement 3. Estimated Additional Burden Hours for the Confirmation of
Prescription Release Requirement 4. Estimated Total Labor Cost Burden for the Confirmation of
Prescription Release Modification 5. Capital and Other Non-Labor Costs for the Confirmation of
Prescription Release Requirement B. Recording of Automated Telephone Messages C. Total Burden for the Modifications to the Rule
XII. Regulatory Flexibility Act A. Need for and Objectives of the Rule Amendments 1. Amendments Affecting Prescribers 2. Amendments Affecting Sellers B. Significant Issues Raised by Public Comments in Response to
the IRFA, Including Any Comments Filed by the Chief Counsel for
Advocacy of the Small Business Administration, and the Agency's
Response, Including Any Changes Made in the Final Rule Amendments 1. Amendments Affecting Prescribers
[[Page 50669]] 2. Amendments Affecting Sellers C. Description and Estimate of the Number of Small Entities to
Which the Amendments Will Apply or Explanation Why No Estimate Is
Available D. Description of the Projected Reporting, Recordkeeping and
Other Compliance Requirements of the Amendments, Including an
Estimate of the Classes of Small Entities That Will Be Subject to
the Requirement and the Type of Professional Skills Necessary for
Preparation of the Report or Record 1. Amendments Affecting Prescribers 2. Amendments Affecting Sellers E. Steps Taken To Minimize the Significant Impact, if Any, of
the Amendments, Including Why Any Significant Alternatives Were Not
Adopted 1. Steps and Alternatives for Amendments Affecting Prescribers 2. Steps and Alternatives for Amendments Affecting Sellers
XIII. Congressional Review Act
I. Background
A. Overview of the Contact Lens Rule In 2003, Congress enacted the Fairness to Contact Lens Consumers
Act (``FCLCA'' or ``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.
--------------------------------------------------------------------------- \1\ 15 U.S.C. 7601-7610 (Pub. L. 108-164). \2\ Contact Lens Rule, 16 CFR part 315 (2015).
--------------------------------------------------------------------------- The Contact Lens Rule (``Rule'') promotes competition in retail
sales of contact lenses by facilitating consumers' ability to
comparison shop for contact lenses. When an eye care practitioner
(``prescriber'') \3\ completes a contact lens fitting, the Rule
requires that the prescriber automatically provide the patient with a
portable copy of the patient's prescription, whether or not the patient
requests it.\4\ The Rule also requires that the prescriber verify or
provide such prescriptions to authorized third parties. At the same
time, the Rule requires that sellers only sell contact lenses in
accordance with valid prescriptions written by licensed prescribers
that were either (a) presented to the seller by the patient or a
designated agent of the patient or (b) verified by direct communication
with the prescriber.\5\
--------------------------------------------------------------------------- \3\ Under the Rule, prescriber is defined as an ophthalmologist,
optometrist, or other person permitted under State law to issue
prescriptions for contact lenses in compliance with any applicable
requirements established by the Food and Drug Administration. `Other
person,' in this context, includes dispensing opticians who are
permitted under State law to issue prescriptions and who are
authorized or permitted under State law to perform contact lens
fitting services. 16 CFR 315.2. \4\ The Commission also notes that apart from requiring that the
contact lens fitting be complete, the FCLCA and Rule do not include
any other requirements or exceptions that would permit a prescriber
to withhold a patient's contact lens prescription following a
fitting. 16 CFR 315.3(a)(1). Therefore, prescribers must
automatically provide patients with copies of their prescriptions
following their fitting, regardless of whether patients indicate an
intention to purchase contact lenses--no matter the quantity (and
even an annual supply)--from their prescribers. \5\ 16 CFR 315.5(a).
--------------------------------------------------------------------------- The Rule further 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) The prescriber confirms the
prescription is accurate; (2) the prescriber informs the seller that
the prescription is inaccurate and provides an accurate 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 business 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\ 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\
--------------------------------------------------------------------------- \6\ 16 CFR 315.5(b)-(c). \7\ 16 CFR 315.5(d). \8\ 16 CFR 315.5(e).
--------------------------------------------------------------------------- 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.\9\ 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.\10\
--------------------------------------------------------------------------- \9\ 16 CFR 315.6. \10\ 16 CFR 315.11(a). The Rule also preempts any other state or
local laws or regulations that are inconsistent with the Act or the
relevant section of the Rule, to the extent of the inconsistency. 16
CFR 315.11(b).
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B. History of the Rule The FTC has more than three decades of regulatory and research
experience regarding the optical goods industry; this history continues
to inform the basis and purpose of the Contact Lens Rule and this rule
review. In addition to the Rule, the Commission enforces the Ophthalmic
Practice Rules (known as the ``Eyeglass Rule''), initially promulgated
in 1978.\11\ Prior to the Eyeglass Rule, surveys of optometrists found
that a majority of prescribers imposed some restriction on the
availability of the patient's prescription, usually by either refusing
to release prescriptions or charging an additional fee to do so.\12\
Prescribers also used waivers and liability disclaimers to discourage
comparison shopping, mislead consumers, and frighten them into
purchasing ophthalmic goods from the prescriber.\13\ The Commission
determined that these actions reduced consumers' ability to obtain the
lowest prices and hindered competition in the optical marketplace.\14\
To address these problems, the Eyeglass Rule required 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\
--------------------------------------------------------------------------- \11\ Final Trade Regulation Rule, Advertising of Ophthalmic
Goods and Services, 43 FR 23992 (June 2, 1978) [hereinafter Eyeglass
I]. The Rule was revised in 1992, with the revisions codified at 16
CFR part 456. Ophthalmic Practice Rules, 57 FR 18822 (May 1, 1992). \12\ 43 FR at 23998. See also FTC, ``Staff Report on Advertising
of Ophthalmic Goods and Services and Proposed Trade Regulation
Rule'' 240-48 (1977) [hereinafter 1977 Staff Report] (detailing
myriad accounts of prescribers refusing to release eyeglass
prescriptions to their patients), https://www.ftc.gov/system/files/documents/reports/staff-report-advertising-ophthalmic-goods-services-proposed-trade-regulation-rule-16-cfr-part-456/r611003-staff_report_on_advertising_of_ophthalmic_goods_and_services_and_proposed_trade_regulation.pdf. \13\ 43 FR at 23998; Am. Optometric Ass'n v. FTC, 626 F.2d 896,
916 (D.C. Cir. 1980) (noting considerable ``evidence of abuse'' by
prescribers); see also 1977 Staff Report, supra note 12, at 277. \14\ FTC, ``The Strength of Competition in the Sale of Rx
Contact Lenses: An FTC Study'' 45-46 (2005), https://www.ftc.gov/sites/default/files/documents/reports/strength-competition-sale-rx-contact-lenses-ftc-study/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 FTC, ``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.
--------------------------------------------------------------------------- The Eyeglass Rule, however, did not encompass contact lens
prescriptions. While a majority of states enacted their own statutes
requiring some form of contact lens prescription release,\16\ many
prescribers continued to withhold prescriptions for contact lenses.\17\
This,
[[Page 50670]]
and other prescriber practices (such as requiring liability waivers,
refusing to verify prescriptions when consumers tried to buy lenses
from third-party sellers, and encouraging manufacturers not to
distribute contact lenses to third-party sellers), made it challenging
for consumers to obtain lenses from anyone other than their
prescribers.\18\ According to Congress, these obstacles were rooted in
an ``inherent conflict of interest'' in that ``[u]nlike medical doctors
who are prohibited from selling the drugs they prescribe, eye doctors
and optometrists . . . are able to fill the contact lens prescriptions
they write.'' \19\ Third-party sellers are thus forced to compete for
the sale of lenses with the individual who is writing the
prescription.\20\ To address this inherent conflict of interest and
achieve freedom of choice and the benefits of competition for contact
lens consumers, Congress passed the Fairness to Contact Lens Consumers
Act in 2003,\21\ and, in 2004, the Commission issued the Contact Lens
Rule,\22\ implementing the Act.
--------------------------------------------------------------------------- \16\ By 2003, more than two-thirds of states had laws requiring
some form of contact lens prescription release. H.R. Rep. No. 108-
318, 108th Cong., 1st Sess. 4 (2003), at 8 (2003). \17\ See id. at 4 (noting that ``[t]he practice of optometrists
withholding the prescription [for contact lenses] has limited the
consumer's ability to shop for the best price and has impacted
competition''); Fairness to Contact Lens Consumers Act: Hearing
Before the Subcomm. on Commerce, Trade, and Consumer Protection of
the H. Comm. on Energy and Commerce, 108th Cong. 1 (2003)
[hereinafter FCLCA Subcomm. Hearing] (statement of Ami Gadhia,
Consumers Union) (noting that multiple surveys of consumers in Texas
had found considerable numbers were unable to obtain their contact
lens prescription from their prescribers). \18\ H.R. Rep. No. 108-318, at 4; FCLCA Subcomm. Hearing, supra
note 17 (statements of Howard Beales, Jonathan Coon, Ami Gadhia,
Robert Hubbard, Maria Martinez, Rep. W. J. Tauzin; Peggy Venable).
See also In re Disposable Contact Lens Antitrust Litig., No. 94-MDL
1030-J-20A (M.D. Fla.), in which the Attorneys General of 31 states
alleged that eye-care professionals engaged in an organized effort
to prevent or hinder consumers from obtaining their contact lens
prescriptions. 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 Attorneys General, 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,
manufacturers agreed to sell contact lenses to alternative
distribution channels. \19\ H.R. Rep. No. 108-318, at 5. See also Letter from Senators
Richard Blumenthal and Orrin G. Hatch of the United States Senate
Regarding the Contact Lens Rule Rulemaking Proceeding and the
Proposed Rule Set Forth in the Notice of Proposed Rulemaking (Aug.
11, 2017) (recognizing the ``inherent conflict of interest'' and
noting that the FCLCA was made necessary by ``the unique nature of
the contact lens marketplace''), https://www.ftc.gov/system/files/filings/initiatives/677/public_comment_from_senators_blumenthal_and_hatch_re_contact_lens_rulemaking.pdf [hereinafter Blumenthal Letter]. \20\ H.R. Rep. No. 108-318, at 4; FCLCA Subcomm. Hearing, supra
note 17 (statements of Rep. W.J. Tauzin) (noting there is a
``classic conflict of interest that robs the consumers of the
ability to shop competitively for the best price,'' and stating that
the FCLCA takes the ``necessary steps to remedy this stranglehold on
contact lens competition''). \21\ 15 U.S.C. 7601-7610. The FCLCA passed with a vote of 406 in
favor and 12 opposed in the House, and unanimous consent in the
Senate. \22\ Contact Lens Rule, 69 FR 40482 (July 2, 2004) (codified at
16 CFR pt. 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.
--------------------------------------------------------------------------- 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 \23\ and Congress recognized
that consumers may be harmed by contact lenses purchased with an
expired, inaccurate, or otherwise invalid prescription,\24\ the Act
requires that contact lenses be sold only to patients with valid
prescriptions, which they receive after contact lens fittings by a
prescriber. The Act and the Rule only allow sales of contact lenses
when a patient presents a seller with a copy of the prescription or the
seller has verified the patient's prescription with the prescriber.\25\
Sellers also are prohibited from altering a contact lens
prescription.\26\
--------------------------------------------------------------------------- \23\ See, e.g., FTC, ``Possible Barriers to E-Commerce: Contact
Lenses, A Report from the Staff of the Federal Trade Commission'' 8-
9 (2004), https://www.ftc.gov/sites/default/files/documents/advocacy_documents/possible-anticompetitive-barriers-e-commerce-contact-lenses-report-staff-ftc/040329clreportfinal.pdf. \24\ Contact Lens Rule, 69 FR 40482. \25\ 16 CFR 315.5(a). \26\ 16 CFR 315.5(e).
--------------------------------------------------------------------------- The Act and the Rule further impose obligations on prescribers.
First and foremost, prescribers are required to release a copy of the
prescription to the patient promptly upon completion of the contact
lens fitting, ``[w]hether or not requested by the patient.'' \27\
Prescribers also are prohibited from requiring: (1) The purchase of
contact lenses as a condition of either prescription release or
verification, (2) a separate payment for prescription release or
verification, and (3) that the patient sign a waiver as a condition of
prescription release or verification.\28\
--------------------------------------------------------------------------- \27\ 15 U.S.C. 7601(a)(1); 16 CFR 315.3(a)(1). \28\ 15 U.S.C. 7601(b)(1)-(3); 16 CFR 315.3(b)(1)-(3).
--------------------------------------------------------------------------- Additionally, prescribers are required to provide or verify a
contact lens prescription when ``directed by any person designated to
act on behalf of the patient.'' \29\ Such verification occurs when the
seller provides the prescriber with a consumer's prescription
information and: (1) The prescriber confirms that the prescription is
accurate, by phone, facsimile, or electronic mail; (2) the prescriber
informs the seller that the prescription is inaccurate and provides the
correct prescription; or (3) the prescriber does not communicate with
the seller within eight business hours of the seller's request for
verification (``passive verification'').\30\ The eight-business-hour
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
that may be lower-priced, or sold by sellers who offer other benefits
or convenience--simply by refusing to respond to verification requests.
--------------------------------------------------------------------------- \29\ 15 U.S.C. 7601(a)(2); 16 CFR 315.3(a)(2). \30\ 15 U.S.C. 7603(d)(1)-(3); 16 CFR 315.5.
--------------------------------------------------------------------------- One outcome of passive verification, however, is that, if a
prescriber does not respond to a verification request containing
inaccurate information or for an invalid prescription within eight
business hours, the prescription is deemed verified; thus, passive
verification allows for the possibility that patients can be sold
lenses for which they do not have a valid prescription. Congress, when
considering the FCLCA, was aware that a passive-verification regime
could, in some instances, allow sellers to sell and ship contact lenses
based on an invalid or inaccurate prescription, and that this could
potentially lead to health risks.\31\ Congress opted for a passive-
verification regime despite this concern in order ``to ensure that
consumers are not caught in the competitive tug-of-war between doctors
and third party sellers for the sale of contact lenses.'' \32\ It was
also envisioned that prescribers would remain diligent in ensuring that
patients did not receive lenses for which they had not been prescribed,
since it is in both prescribers' self-interest and the health and
safety interests of their patients to prevent this from occurring.\33\
In this manner, the passive-verification system was perceived, to a
certain extent, to be self-enforcing, as prescribers would have both a
financial interest and an ethical duty to police invalid, incorrect, or
expired prescriptions.\34\
--------------------------------------------------------------------------- \31\ See, e.g., FCLCA Subcomm. Hearing, supra note 17
(statements of Howard Beales, Federal Trade Commission); id.
(statements of J. Pat Cummings, American Optometric Association)
(``And the problem with passive verification is that people will get
contact lenses without a prescription.''). \32\ H.R. Rep. No. 108-318, at 5. \33\ Contact Lens Rule, 69 FR at 40498. \34\ FCLCA Subcomm. Hearing, supra note 17 (statements of Howard
Beales, Federal Trade Commission) (stating that passive verification
is in many respects self-enforcing). See also id. (statements of
Jonathan Coon, 1-800 CONTACTS) (explaining to the Committee that
from their experience with an existing passive verification-system
in California, doctors have motivation to block invalid-prescription
sales. ``So they tell us if there is any problem with the
prescription, if it's expired, it's invalid, whatever the problem is
with the prescription. If they can tell us, you can believe they
tell us absolutely every time.'').
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[[Page 50671]]
C. Initial Request for Comments in 2015 As part of its periodic review of its rules and guides, on
September 3, 2015, the Commission solicited comments on the Contact
Lens Rule, seeking input on: The economic impact of, and 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.\35\ The comment period for this initial request closed on
October 26, 2015. The Commission received approximately 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 consumers.\36\
--------------------------------------------------------------------------- \35\ Contact Lens Rule Request for Comment (``RFC''), 80 FR
53272 (Sept. 3, 2015). \36\ Comment figures are approximations because identical
comments are sometimes submitted more than once. RFC comments are
available at https://www.ftc.gov/policy/public-comments/2015/09/initiative-621.
---------------------------------------------------------------------------
D. Notice of Proposed Rulemaking in 2016 After a review of comments, surveys, other submitted information,
and its own enforcement experience, the Commission determined that the
overall weight of the evidence demonstrated a need to improve
compliance with the Rule's automatic prescription-release requirement,
as well as a need to create a mechanism for monitoring and enforcing
the Rule.\37\ To achieve this, the Commission issued a Notice of
Proposed Rulemaking (``NPRM'') on December 7, 2016 that proposed to add
a signed-acknowledgment requirement.\38\ The signed-acknowledgment
requirement was to be triggered once the prescriber presented the
prescription to the patient, and the acknowledgment form could be in
either paper or electronic format. As proposed, the acknowledgment form
was to be entitled ``Patient Receipt of Contact Lens Prescription''
(``Signed Acknowledgment''), and 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.'' Prescribers
would be required to maintain copies of the acknowledgment forms in
paper or electronically for not less than three years.
--------------------------------------------------------------------------- \37\ Notice of Proposed Rulemaking, 81 FR 88526 (Dec. 7, 2016)
[hereinafter NPRM]. \38\ Id. The NPRM also proposed a technical amendment, to remove
the words ``private label'' from Sec. 315.5(e) to conform the
language of the Rule to that of the FCLCA.
--------------------------------------------------------------------------- The NPRM sought comment on this proposal as well as the following
issues: The provision of additional copies of prescriptions, the amount
of time for a prescriber to respond to such a request, the use of
patient portals to release prescriptions, and potential modifications
to address concerns about automated telephone verification calls. The
sixty-day comment period for the Commission's NPRM closed on January
30, 2017. In response to its NPRM, the Commission received over 4,000
additional comments, many from prescribers concerned about the impact
of the proposed signed-acknowledgment requirement.\39\ After
considering these and other comments, the Commission determined that
certain issues deserved additional discussion and examination. To
obtain additional input and more fully consider commenter concerns, the
Commission solicited additional comments \40\ and held a public
workshop on the Contact Lens Rule and the Evolving Contact Lens
Marketplace on March 7, 2018. The workshop included six panels,
covering issues relating to the overall contact lens marketplace,
health and safety, competition, purchasing and verification, the
proposed Signed Acknowledgment and consumer choice, and the future of
contact lens prescribing and selling.\41\ In response to the
Commission's request and workshop, the Commission received
approximately 3,400 additional comments from a wide range of
commenters, including numerous consumers and prescribers, as well as
industry associations, state attorneys general, contact lens
manufacturers, and contact lens sellers.\42\
--------------------------------------------------------------------------- \39\ NPRM comments available at https://www.ftc.gov/policy/public-comments/2016/10/initiative-677. \40\ Public Workshop Examining Contact Lens Marketplace and
Analyzing Proposed Changes to the Contact Lens Rule, 82 FR 57889
(Dec. 8, 2017). \41\ Workshop transcripts available at https://www.ftc.gov/news-events/events-calendar/2018/03/contact-lens-rule-evolving-contact-lens-marketplace. \42\ Workshop comments available at https://www.ftc.gov/policy/public-comments/2018/01/initiative-733.
---------------------------------------------------------------------------
E. Supplemental Notice of Proposed Rulemaking After reviewing the comments submitted in response to the public
workshop and Notice of Proposed Rulemaking, the Commission issued a
Supplemental Notice of Proposed Rulemaking (``SNPRM'') on May 28, 2019
that modified its previous proposal for a Signed Acknowledgment by
instituting a more flexible Confirmation of Prescription Release
provision.\43\ In addition, the SNPRM put forth new proposals to modify
the Rule by: (a) Adding a definition of the term ``provide to the
patient a copy,'' to allow the prescriber to provide the patient with a
digital copy of the patient's prescription in lieu of a paper copy; (b)
providing forty business hours as the time period for which a
prescriber must provide a prescription upon request to a person
designated to act on behalf of the patient; (c) creating new message
delivery and recordkeeping requirements for sellers using automated
telephone verification messages; (d) amending and clarifying the
prohibition on seller alteration of prescriptions; and (e) requiring
that sellers provide a method that would allow patients to present
their prescriptions to the seller.
--------------------------------------------------------------------------- \43\ Supplemental Notice of Proposed Rulemaking, 84 FR 24664
(May 28, 2019) [hereinafter SNPRM].
--------------------------------------------------------------------------- The Commission requested comment on its SNPRM proposal; the sixty-
day comment period closed on July 29, 2019. In response to its SNPRM,
the Commission received approximately 200 unique comments (and
approximately 900 comments total) from a variety of stakeholders,
including prescribers and prescriber-trade organizations, contact lens
manufacturers, contact lens sellers, legislators, state attorneys
general, economic think tanks and academics, consumer-interest
organizations, and individual consumers themselves.\44\ The majority of
commenters opined on the Confirmation of Prescription Release proposal,
and many also commented on the Commission's new proposals regarding
prescription verification and alteration. This Statement of Basis and
Purpose for the Final Rule summarizes
[[Page 50672]]
the relevant comments received in response to the proposals set forth
in the NPRM and SNPRM and explains the Commission's analyses and
decisions to amend or not amend the Rule.
--------------------------------------------------------------------------- \44\ SNPRM comments available at https://www.regulations.gov/docket?D=FTC-2019-0041.
---------------------------------------------------------------------------
II. Final Rule Pertaining to Confirmation of Prescription Release The following sections discuss the Confirmation of Prescription
Release proposal in the SNPRM, the comments to the SNPRM in support of
and opposition to the Confirmation of Prescription Release proposal,
the Commission's analysis and conclusions, and the amendments to the
Final Rule instituting a Confirmation of Prescription Release. Because
many of the comments focused on the Commission's basis for its SNPRM
proposal, and whether that basis is supported by evidence in the
record, the Commission also reiterates the basis set forth in the SNPRM
and discusses related comments and subsequent determinations in this
Statement of Basis and Purpose for the final amended Contact Lens Rule. The Commission's authority to modify the Rule and implement a
Confirmation of Prescription Release requirement derives from the
FCLCA, which directed the FTC to prescribe implementing rules, and
authorized the Commission to investigate and enforce the Act in the
same manner, by the same means, and with the same jurisdictional powers
and duties as a trade regulation rule under the Federal Trade
Commission Act.\45\ Congress clearly intended that prescriptions be
provided to all consumers at the completion of the contact lens fitting
process.\46\ Survey evidence, the record of these proceedings, and the
Commission's own experience with the Rule indicate that is not
occurring at anywhere near the rate Congress intended. Consequently,
the Commission believes that imposing a Confirmation of Prescription
Receipt requirement is critical to effectuate congressional intent to
the fullest extent.\47\
--------------------------------------------------------------------------- \45\ 15 U.S.C. 7601-7610 (Pub. L. 108-164). \46\ 15 U.S.C. 7601; see also H.R. Rep. No. 108-318, at 4 (2003)
(``The practice of optometrists withholding the prescription has
limited the consumer's ability to shop for the best price and has
[adversely] impacted competition.''). \47\ See H.R. Rep. No. 108-318, at 6 (2003) (``The goal of this
legislation is to allow consumer access to their contact lens
prescriptions. . . .'').
--------------------------------------------------------------------------- In a comment to the NPRM, the American Optometric Association
(``AOA'') contended that the Commission does not have the authority to
add requirements to the Rule that are not found in the text of the
FCLCA.\48\ According to the AOA, because the FCLCA is a statute that
``carefully enumerates specific substantive requirements but not
others''--as opposed to a general grant of authority--the agency
charged with administering the FCLCA ``should not add additional
requirements that Congress did not enact.'' \49\
--------------------------------------------------------------------------- \48\ American Optometric Association (NPRM Comment #3830). \49\ Id.
--------------------------------------------------------------------------- The Commission does not agree with this interpretation. As noted
above, the FCLCA contains an express delegation of authority to the FTC
to craft rules to carry out the Act.\50\ Pursuant to this delegation,
the FTC has broad rulemaking authority to implement requirements for
the purpose of preventing unfair or deceptive acts or practices in or
affecting commerce, including failure to provide patients with copies
of their prescriptions.\51\ The proposed modification requiring that
patients sign a Confirmation of Prescription Release is consistent with
the statute and falls well within the Commission's statutory
jurisdiction under the FCLCA.\52\
--------------------------------------------------------------------------- \50\ 15 U.S.C. 7607. \51\ See id. (directing the FTC to ``prescribe rules pursuant to
section 57a of this title to carry out [the FCLCA]''); 15 U.S.C.
57a(a)(1)(B) (authorizing the FTC to prescribe ``rules which define
with specificity acts or practices which are unfair or deceptive
acts or practices in or affecting commerce,'' including rules that
contain ``requirements prescribed for the purpose of preventing such
acts or practices''); 15 U.S.C. 7601(a) (mandating that when a
prescriber completes a contact lens fitting, the prescriber
``whether or not requested by the patient, shall provide to the
patient a copy of the contact lens prescription''). \52\ 15 U.S.C. 7601(a), 7607. AOA's stance that a statute's
enumeration of some requirements but not others necessarily
signifies that Congress deliberately excluded the non-included
requirements is also incorrect in the rulemaking context. It is well
established that the canon of statutory interpretation expressio
unius est exclusion alterius (``the expression of one is the
exclusion of others'') does not have force in the administrative
setting, where Congress is presumed to have left to reasonable
agency discretion questions that it has not directly resolved. See
Adirondack Med. Ctr. v. Sebelius, 740 F.3d 692, 697 (D.C. Cir.
2014); St. Marks Place Hous. Co. v. U.S. Dep't of Hous. & Urban
Dev., 610 F.3d 75 (D.C. Cir. 2010); AFL-CIO v. Chao, 409 F. 3d 377
(D.C. Cir. 2005); Mobile Comm'cns Corp. of Am. v. FCC, 77 F.3d 1399,
1404-05 (D.C. Cir. 1996); see also Farrell v. Pompeo, No. 17-490,
2019 U.S. Dist. LEXIS 205831, *25-27 (D.C. Cir. Nov. 27, 2019).
---------------------------------------------------------------------------
A. Proposed Modifications in the SNPRM The SNPRM proposed to amend the NPRM's signed-acknowledgment
proposal by replacing that requirement with a shorter and more flexible
Confirmation of Prescription Release provision. Rather than requiring,
as proposed in the NPRM, that prescribers request that each contact
lens patient sign a form with mandatory language acknowledging receipt
of the prescription and an understanding of the right to purchase
lenses elsewhere,\53\ in the SNPRM the Commission proposed requiring
prescribers instead to do one of the following:
--------------------------------------------------------------------------- \53\ NPRM, 81 FR at 88559 (The form would have stated: ``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.'').
--------------------------------------------------------------------------- (A) Request that the patient acknowledge receipt of the contact
lens prescription by signing a separate statement confirming receipt of
the contact lens prescription; (B) Request that the patient sign a prescriber-retained copy of a
contact lens prescription that contains a statement confirming receipt
of the contact lens prescription; (C) Request that the patient sign a prescriber-retained copy of the
sales receipt for the examination that contains a statement confirming
receipt of the contact lens prescription; or (D) If a digital copy of the prescription was provided to the
patient (via methods including an online portal, electronic mail, or
text message), retain evidence that such prescription was sent,
received, or made accessible, downloadable, and printable.\54\
--------------------------------------------------------------------------- \54\ SNPRM, 84 FR at 24667.
--------------------------------------------------------------------------- The Commission's proposal provided sample language for confirmation
options (A), (B), and (C),\55\ but also allowed prescribers to craft
their own wording of the signed confirmation for these options if they
so desired. Unlike the NPRM's signed-acknowledgment proposal, which
applied to all prescribers, the SNPRM's Confirmation of Prescription
Release proposal only applied to prescribers with a financial interest
in the sale of contact lenses.\56\
--------------------------------------------------------------------------- \55\ The Commission said it had no wish to burden prescribers
with the task of formulating adequate confirmation language if they
would prefer to use a sentence from the language the Commission
previously proposed: ``My eye care professional provided me with a
copy of my contact lens prescription at the completion of my contact
lens fitting.'' The Commission said use of such language would
satisfy the proposed requirement. SNPRM, 84 FR at 24683. \56\ Id.
---------------------------------------------------------------------------
B. Basis for SNPRM Confirmation of Prescription Release Proposal The Commission explained in the SNPRM that it based its
Confirmation of Prescription Release proposal on a variety of evidence,
including: Multiple consumer surveys consistently showing prescriber
non-compliance with, and lack of consumer awareness of, the Rule's
prescription-release requirement; numerous accounts of prescribers'
failure to release prescriptions; the
[[Page 50673]]
persistently high number of verifications, many of which would be
unnecessary were consumers in possession of their prescriptions; the
regulatory structure of the contact lens market, which requires a
consumer to obtain lenses pursuant to a prescription while permitting
prescribers to sell what they prescribe; and the lack of credible
empirical evidence rebutting or contradicting the evidence that
prescribers are not automatically releasing prescriptions, and that
consumers are not fully aware of their rights.\57\ The Commission also
noted that the potential benefit of increasing the number of patients
in possession of their prescriptions is substantial for consumers,
sellers, and prescribers: Namely, increased flexibility and choice for
consumers; a reduced verification burden for prescribers and sellers;
and a reduced likelihood of errors associated with incorrect, invalid,
and expired prescriptions and, consequently, improved patient
safety.\58\ The Commission further explained that it faces serious
challenges enforcing the Rule and monitoring compliance because it
often comes down to the word of the patient against the word of the
prescriber, which might require the Commission to issue administrative
subpoenas and conduct investigational hearings--which could be
resource-intensive for the Commission and costly, time-consuming, and
disruptive for prescribers--in order to investigate each potential
violation.\59\ The Commission thus concluded that some form of retained
documentation is necessary to improve its ability to enforce and
monitor prescriber compliance with the prescription-release
requirements.\60\
--------------------------------------------------------------------------- \57\ Id. at 24680-81. \58\ Id. at 24681. \59\ Id. \60\ Id.
--------------------------------------------------------------------------- The Commission also determined that signage--an alternative
suggested by NPRM commenters--was not an appropriate or effective means
of ensuring that patients receive their prescriptions as required by
law.\61\ Lastly, the Commission determined that despite commenter
concerns, the burden to obtain signatures and retain records would be
relatively minimal and outweighed by the benefits.\62\ The Commission,
however, was receptive to an NPRM commenter recommendation to modify
the signed-acknowledgment proposal in order to further reduce the
burden and allow for greater flexibility,\63\ and thus the SNPRM's
Confirmation of Prescription Release proposal included three new
options for prescribers to obtain or establish proof of prescription
release and exempted prescribers who lacked a financial interest in the
sale of contact lenses.\64\ According to the Commission, the
Confirmation of Prescription Release proposal retained most of the
benefits of the NPRM's signed-acknowledgment proposal, but would be
less disruptive and burdensome for prescribers.\65\
--------------------------------------------------------------------------- \61\ Id. \62\ Id. at 24681-82. \63\ The recommendation was submitted by the National
Association of Optometrists and Opticians in its comments to the
Contact Lens Workshop and the NPRM, see id. at 24680 (citing
National Association of Optometrists and Opticians (WS Comment
#3208)). \64\ SNPRM, 84 FR at 24683. \65\ Id.
---------------------------------------------------------------------------
C. Comments on the Confirmation of Prescription Release Proposal and
the Basis for Such Proposal Commenter response to the Commission's proposal in the SNPRM was
varied. Some commenters applauded the proposed amendments as
improvements to the prior signed-acknowledgment proposal, and as a
balanced response to competing interests of consumers, sellers, and
prescribers.\66\ Some, for instance, praised the confirmation proposal
as an attempt to increase consumer access to prescriptions while making
it easier and more efficient for prescribers to adhere to the patient-
acknowledgment requirement by allowing flexible methods for obtaining
the patient's signature.\67\ Other commenters, however, asserted that
the proposal watered down prescriber obligations and would thus be less
effective than the NPRM's signed-acknowledgment proposal in ensuring
that consumers receive their prescriptions and are aware of their
rights.\68\ And several commenters, primarily contact lens prescribers,
stated that despite the increased flexibility, the Confirmation of
Prescription Release proposal still created too much of a burden for
prescribers, and they criticized the Commission's approach and the
evidence relied upon.\69\
--------------------------------------------------------------------------- \66\ R Street Institute (SNPRM Comment #15) (``The Commission's
proposal is both reasonable and not overly burdensome.''); Grimm
(SNPRM Comment #36) (``There is no doubt that the modified Contact
Lens Rule should be embraced by prescribers, sellers, and consumers
as an improvement to consumer products trade rules.''); Americans
for Tax Reform (SNPRM Comment #72) (``These changes strike the
correct balance between promoting the free market and protecting
important consumer rights.''); Lens.com (SNPRM Comment #85) (``We
believe you have struck the correct balance . . . .''); Coalition
for Contact Lens Consumer Choice (SNPRM Comment #89) (``What the FTC
is proposing is a common sense, minimally-burdensome rule that
optometrists, ophthalmologists, and consumers alike can and should
support.''); Taxpayers Protection Alliance (SNPRM Comment #118)
(``Although we are often critical of government overreach and work
hard to make government smaller, we believe that the FTC's proposed
Contact Lens Rule is a government rule that works for taxpayers and
consumers and creates an open transparent contact lens market in the
US where taxpayers have real choice and there is real competition in
the marketplace.''); Attorneys General of 27 States (SNPRM Comment
#139) (``We believe the proposed modifications in the SNPRM are
reasonable modifications that balance the interests of consumers,
eye care professionals, and the eye care industry.''). \67\ Anonymous (SNPRM Comment #63); Rawson (SNPRM Comment #68)
(``This proposed rule allows prescribers the ability to model the
rule to best fit their practice, but still give the consumers the
protection and the knowledge they need.''). \68\ Consumer Reports (SNPRM Comment #133); 1-800 CONTACTS
(SNPRM Comment #135). \69\ American Optometric Association (SNPRM Comment #96); Reeder
(SNPRM Comment #55) (even signature on prescription or patient
receipt is burdensome); Kegler (SNPRM Comment #99) (proposal will
still place financial and administrative burdens on prescribers).
---------------------------------------------------------------------------
1. Comments About the Need for the Confirmation of Prescription Release
and Whether Prescribers Are Complying With the Rule's Automatic
Prescription Release Requirement
a. Survey Evidence as Proof of Non-Compliance Many of the SNPRM comments focused on the need for a Signed
Acknowledgment or Confirmation of Prescription Release, and on whether
evidence in the record supports the Commission's determination that
prescribers are not complying with the Rule's prescription-release
requirement. Several commenters, such as 1-800 CONTACTS, Consumer
Action, and the Attorneys General of Twenty-Seven States, contended (as
they did in comments responding to either the NPRM, the Contact Lens
Workshop, or both) \70\ that prescriber noncompliance remains a
problem, and that millions of Americans are not receiving their
prescriptions after a contact lens fitting.\71\ The Attorneys General
of Twenty-Seven States, for instance, commented that consumers in their
states continue to report that prescribers are failing to automatically
provide patient prescriptions in writing.\72\ Likewise, the online
seller 1-800 CONTACTS submitted a new survey of consumers, conducted
for it by the
[[Page 50674]]
polling firm Dynata (formerly known as Survey Sampling International),
showing that prescriber compliance has not markedly improved, despite
the attention focused on automatic-prescription-release obligations
since the FTC initiated its rule review in 2015.\73\ According to the
new survey, nearly 49% of contact lens patients report that their
prescribers did not automatically give them their prescription after
their eye examination.\74\ Of those who did not receive their
prescription automatically, a little more than half received it after
requesting it, while 43% never received their prescription.\75\
Extrapolating this data to the general population of 45 million U.S.
contact lens users \76\ would mean there are approximately 22 million
annual violations of the Contact Lens Rule, and that each year more
than 9.4 million contact lens users do not receive their
prescriptions.\77\ The 2019 consumer survey data is consistent with
several prior surveys of contact lens users conducted in 2014, 2015,
2016, and 2017 on behalf of 1-800 CONTACTS and the consumer rights
organization Consumer Action,\78\ as well as a survey of eyeglass
wearers (who, per the FTC's Eyeglass Rule, are also to automatically
receive their prescriptions following a refractive eye exam) conducted
on behalf of Warby Parker in 2015.\79\
--------------------------------------------------------------------------- \70\ See 1-800 CONTACTS (NPRM Comment #3898); 1-800 CONTACTS (WS
Comment #3207); Consumer Action (NPRM Comment #3721); Comments of
the Attorneys General of 20 States (NPRM Comment #3804). \71\ 1-800 CONTACTS (SNPRM Comment #135); Attorneys General of
27 States (SNPRM Comment #139). \72\ Attorneys General of 27 States (SNPRM Comment #139). \73\ 1-800 CONTACTS (SNPRM Comment #135). \74\ 1-800 CONTACTS (SNPRM Comment #135, Ex. B). The poll was of
1011 contact lens users between the ages of 18-49, and the relevant
questions asked were ``At your last eye exam, did the eye care
provider provide you with a copy of your contact lens
prescription?'' and ``In order to obtain a copy of your
prescription, did you have to ask your eye care provider for it?''
Approximately 41% said they received it automatically, 49% said they
did not, and 10% did not recall or were unsure. \75\ Id. \76\ Centers for Disease Control, Healthy Contact Lens Wear and
Care, Fast Facts, https://www.cdc.gov/contactlenses/fast-facts.html. \77\ This is based on the estimate--long used to calculate the
financial burden of the Rule for Paperwork Reduction Act purposes--
that consumers obtain one contact lens prescription per year. See,
e.g., SNPRM, 84 FR at 24692; Paperwork Reduction Act Proposed
Collection; Comment Request, 81 FR at 31940; Paperwork Reduction Act
Proposed Collection; Comment Request, 78 FR at 9392. \78\ SNPRM, 84 FR at 24671-72. \79\ NPRM, 81 FR at 88531.
--------------------------------------------------------------------------- Some commenters also pointed to previously-submitted evidence
indicating that many U.S. contact lens users are still unaware of their
right to automatically receive their prescriptions and take them
elsewhere for filling.\80\ While commenters to the SNPRM did not submit
updated polling data on consumer awareness, several cited previously-
submitted data indicating that between 46-60% of consumers are unaware
that under federal law a prescriber is required to provide the patient
with a copy of their prescription after they complete their contact
lens exam.\81\
--------------------------------------------------------------------------- \80\ Coalition for Contact Lens Consumer Choice (SNPRM Comment
#89); Consumer Action (SNPRM Comment #101); 1-800 CONTACTS (SNPRM
Comment #135). \81\ Consumer Action (SNPRM Comment #101) (``Our survey showed a
fundamental lack of understanding by consumers about their automatic
right to receive a copy of their prescription''); 1-800 CONTACTS
(SNPRM Comment #135); see SNPRM 84 FR at 24672 (discussing polls of
consumer knowledge of their rights).
--------------------------------------------------------------------------- Another commenter, the National Hispanic Medical Association
(``NHMA''), noted that polls show that Hispanic patients are
disproportionately impacted by prescribers' failure to release
prescriptions, and are less likely to understand their rights under the
FCLCA.\82\ According to the NHMA, ``Our community continually has been
victimized and denied their prescriptions by prescribers and doctors at
a higher rate than most other Americans. We strongly believe that more
must be done to ensure patients are informed of their rights and given
copies of their prescriptions.'' \83\
--------------------------------------------------------------------------- \82\ National Hispanic Medical Association (SNPRM Comment #146). \83\ Id.
--------------------------------------------------------------------------- A number of SNPRM commenters, however, were critical of the polling
data provided to, and relied upon by, the Commission. The American
Academy of Ophthalmology (``AAO'') asserted that data showing
prescriber non-compliance consisted of ``industry-sponsored surveys''
and was therefore unreliable.\84\ AAO added that it is ``unaware of
issues'' with prescribers failing to release prescriptions, and stated
its members ``know that ophthalmology has a strong record of
compliance.'' \85\ Likewise, the American Society of Cataract and
Refractive Surgery (``ASCRS'') asserted that there is no independent
third-party evidence suggesting physicians are not providing
prescriptions to patients, and that the Commission is basing compliance
on ``survey polls sponsored by stakeholders with financial interest in
the sale of contact lenses.'' \86\ According to the ASCRS, before
amending the Rule, the Commission should obtain data from a
disinterested organization.\87\
--------------------------------------------------------------------------- \84\ American Academy of Ophthalmology (SNPRM Comment #136). \85\ Id. \86\ American Society of Cataract and Refractive Surgery (SNPRM
Comment #127). \87\ Id.
--------------------------------------------------------------------------- The AOA was highly critical of polling data supplied by 1-800
CONTACTS, and stated that since the online seller, in its advertising,
encouraged consumers to ``skip the trip to the optometrist'' and
instead renew prescriptions online (via telemedicine), the online
seller has a demonstrated bias against optometrists that taints the
material it submits.\88\ The AOA further stated that some consumer
survey findings may be misleading because it is ``very typical'' for
consumers to request their prescriptions before their contact lens
fitting is complete, and thus before prescribers are obligated--under
the Rule and the FCLCA--to release them to consumers.\89\ Therefore,
some consumers might indicate on a survey that they were required to
ask for their prescriptions when, in fact, they asked before they were
entitled to receive them. As support for this contention, AOA stated
that it surveyed some of its members and found that 91.7% ``indicated
that there are times when a patient will ask for his/her prescription
prior to the finalization of the contact lens fitting.'' \90\
--------------------------------------------------------------------------- \88\ American Optometric Association (SNPRM Comment #96). \89\ Id. \90\ Id. The AOA reported this result in its comment, and it
stated that its survey was of 629 prescribers, but did not provide
the FTC with the underlying survey data, information about the
manner in which the survey was conducted, how the 629 prescribers
were selected, or the specific questions that were asked.
--------------------------------------------------------------------------- The Commission recognizes that some consumers may think they had to
ask for their prescriptions when, in fact, they would have received
them when their fittings were complete. However, the AOA did not
suggest, nor provide any data or information, as to how often this may
occur, and thus how much it might skew the results of consumer surveys.
As a result, the Commission is unable to estimate what portion of the
49% who stated they did not automatically receive their prescription--
in the most recent survey--gave that response because they
misunderstood when they were entitled to receive their
prescription.\91\
--------------------------------------------------------------------------- \91\ The Commission also notes that eyeglass patients are
entitled to their prescriptions immediately following their exam
(since they do not have to wait for a fitting), and thus would
rarely ask for their prescriptions before they are entitled to them,
and yet two 2015 surveys of eyeglass wearers--one on behalf of Warby
Parker, the other for 1-800 CONTACTS--found that 47% and 66%,
respectively, of eyeglass patients who visited an optometrist
reported that they were not automatically provided a prescription at
the end of their exam. NPRM, 81 FR at 88531 (citing Warby Parker
(Comment #813 on the Ophthalmic Practice Rule), available at https://www.ftc.gov/policy/public-comments/initiative-624); 1-800 CONTACTS
(RFC Comment #568, Ex. B). This would seem to indicate that most
consumer reports that they did not receive their prescriptions are
not based on a misunderstanding of when they are supposed to receive
them.
---------------------------------------------------------------------------
[[Page 50675]] Moreover, even if the Commission were to disregard evidence of
consumers who obtained their prescriptions only after asking for them,
five consumer surveys from 2015 to 2019 (six if the Warby Parker
eyeglass wearers' survey is included) indicate that between 21%-36% of
consumers--approximately 9.5 to 16.2 million contact lens users each
year--did not receive their prescriptions at all after getting fitted
for their lenses.\92\ This level of non-compliance on its own supports
the Commission's recommendation.
--------------------------------------------------------------------------- \92\ This approximation is based on the current estimate that
there are 45 million contact lens users in the United States.
Centers for Disease Control, Healthy Contact Lens Wear and Care,
Fast Facts, https://www.cdc.gov/contactlenses/fast-facts.html. The
results from the individual surveys are as follows: (1) June 2019
survey by Dynata on behalf of 1-800 CONTACTS of 1011 contact lens
users found that 21% said they never received their prescriptions
(1-800 CONTACTS (SNPRM Comment #135)); (2) January 2017 survey by
Caravan ORC International on behalf of Consumer Action of 2018
adults found that 31% of contact lens users said that at their last
eye exam, their doctor did not provide them with a paper copy of
their prescription (Consumer Action (NPRM Comment #3721)); (3)
December 2016 survey of 1000 contact lens users by Survey Sampling
International (``SSI'') on behalf of 1-800 CONTACTS found that 24%
of consumer respondents said they did not receive their prescription
(1-800 CONTACTS (NPRM Comment #3898)); (4) October 2015 SSI survey
of 500 contact lens users and 303 eyeglass users on behalf of 1-800
CONTACTS found that 36% of contact lens users and 39% of eyeglass
wearers said they did not receive their prescription (1-800 CONTACTS
(RFC Comment #568, Ex. B)); (5) May 2015 SSI survey of 2000 contact
lens wearers found that 34% said they did not receive their
prescription (1-800 CONTACTS (RFC Comment #568, Ex. C)); and
(6)November 2014 SSI survey of 2000 contact lens wearers found that
34% said they did not receive their prescription (1-800 CONTACTS
(RFC Comment #568, Ex. C)). As noted in the SNPRM, the manner in
which a few of the questions were phrased in the 2014 and 2015
surveys raised some Commission concerns, since some questions were
leading, lacked an ``I don't know'' response option, and used a
term--``hard copy''--which not all consumers may understand. The
more recent surveys represented an improvement because they included
an option for respondents to acknowledge that they do not recall
whether they received their prescriptions, and used the term ``paper
copy'' rather than ``hard copy.'' SNPRM, 84 FR at 24672.
--------------------------------------------------------------------------- As for commenter criticism that consumer surveys were submitted by
interested parties, the Commission reiterates what it stated in the
SNPRM: while cognizant of the interests of submitting parties, the
Commission, whenever possible, examines the underlying survey data and
methodology to gauge a survey's usefulness and considers factors such
as how many people are queried, how the questions are phrased, and
whether the surveys are conducted in-house or by independent and
established third-party polling firms.\93\ The Commission also
recognizes that all surveys may have methodological limitations, and,
in this instance, does not treat any one survey as controlling. The
Commission, however, also recognizes that multiple surveys conducted by
different sources at different times with similar results bolster the
credibility of each individual survey, as does the fact that in this
matter, one survey, submitted by Consumer Action and conducted by the
third-party polling firm Caravan ORC International, is not from a party
with a direct financial stake in the contact lens industry.\94\
--------------------------------------------------------------------------- \93\ SNPRM, 84 FR at 24672. \94\ The AOA had previously noted, in response to the NPRM, that
Consumer Action has received corporate financial support from, among
others, 1-800 CONTACTS. Id. Consumer Action, however, is a long-
established non-profit consumer advocacy organization without a
financial interest in the outcome of this Rule review.
--------------------------------------------------------------------------- The Commission also notes that despite multiple opportunities and
requests for comment since 2015, the Commission has yet to find or
receive any reliable consumer-survey data rebutting or contradicting
the submitted survey findings, or establishing that consumers
consistently receive their prescriptions. The only empirical evidence
of prescriber compliance in the record is a survey of fifty-seven
``high volume'' prescribers submitted by AOA in response to the NPRM,
which found that 93% responded ``yes'' when asked, ``Do you follow
Federal law and provide patients with a copy of their contact lens
prescription upon completion of a contact lens fitting?'' \95\ For the
reasons stated in the SNPRM,\96\ the Commission does not accord this
survey significant weight, and finds that it does not counter the
multiple consumer surveys conducted over a number of years showing
prescriber non-compliance. The Commission accords the empirical data
from multiple consumer surveys significant weight in establishing that
a substantial percentage of prescribers are not complying with the
automatic-prescription-release provision of the Rule.
--------------------------------------------------------------------------- \95\ SNPRM, 84 FR at 24672; American Optometric Association (WS
Comment #3303, Ex. B). This survey appears to have been conducted by
the AOA itself rather than an outside polling firm. It is not clear
from the AOA's submission how the fifty-seven optometrists were
selected for the survey, what it means to be a ``high volume''
optometrist, or why high-volume optometrists were chosen. \96\ SNPRM, 84 FR at 24673 (noting concerns about the small
sample size, lack of detail as to how prescriber respondents were
recruited, and that the way the question is phrased allows
prescribers to truthfully answer that they provide patients with a
copy of their prescription even if they do not do so for every
patient, and even if they only do so when the patient requests one).
--------------------------------------------------------------------------- Apart from the empirical data discussed above, none of the
commenters submitted new evidence relating to prescriber compliance.
Many individual prescribers, however, continue to comment that they
always comply with the requirement, as do all the prescribers they
know, and therefore they believe that the Commission is looking to
solve a non-existent problem.\97\ Some prescribers also reiterated
that, in their experience, consumers are well aware that they can buy
lenses elsewhere so there is no need to educate them further about
their rights.\98\ And a few prescribers opined that the requirement was
a ``waste of time'' because, in their experience, consumers would
rather not have a copy of their prescription and know that they can
request a copy whenever they want.\99\
--------------------------------------------------------------------------- \97\ See, e.g., Abert (SNPRM Comment #20); Hyndman (SNPRM
Comment #21) (``every OD I know follows'' the FCLCA requirements);
Fair (SNPRM Comment #26) (``I have ALWAYS and will continue to
comply fully with the prescription release requirements of the 2003
Fairness to Contact Lens Consumers Act.''); Hughes (SNPRM Comment
#113) (most optometrists comply); Ridder (SNPRM Comment #720) (every
patient gets their prescription whether they order or ask for it or
not). \98\ Abert (SNPRM Comment #20); Jones (SNPRM Comment #48). \99\ Sikes (SNPRM Comment #114); Morey (SNPRM Comment #142).
--------------------------------------------------------------------------- The Commission has considered these comments but does not believe
they establish that prescribers, on the whole, are complying with the
automatic-release requirement, or that consumers are fully aware of
their prescription-portability rights. Any prescriber may indeed comply
with the Rule but cannot speak for other eye care providers in the
United States, nor for contact lens consumers.\100\ In addition,
several previous comments from prescribers and prescriber organizations
who assert that they comply with the Rule actually revealed that many
prescribers do not fully understand or comply with the Rule's
requirement that prescriptions be provided ``whether or not requested
by the patient.'' \101\
--------------------------------------------------------------------------- \100\ By one estimate, there are approximately 43,000
optometrists and 16,700 ophthalmologists in the U.S. FTC, The
Contact Lens Rule and the Evolving Contact Lens Marketplace, Panel
I: Overview of the Contact Lens Marketplace Tr. at 6 (Mar. 7, 2018),
https://www.ftc.gov/system/files/documents/public_events/1285493/panel_i_overview_of_the_contact_lens_marketplace.pdf [hereinafter
CLR Panel I Tr.]. \101\ See SNPRM, 84 FR at 24673-74, discussing how a number of
prescribers commented that they always offer prescriptions to
consumers, or provide them on request.
--------------------------------------------------------------------------- The Commission does not accord any weight to the comments that
consumers do not want their prescriptions. As
[[Page 50676]]
evidenced by the numerous NPRM comments from consumers urging the
Commission to take action to ensure they are given their prescriptions,
it cannot be doubted that many consumers have a compelling desire to
have them.\102\ And more importantly, Congress made the determination
that prescribers must provide patients with their prescriptions
automatically, ``whether or not requested by the patient.'' \103\
--------------------------------------------------------------------------- \102\ See, e.g., Boue (NPRM Comment #1806); Collins (NPRM
Comment #1811); Hamilton (NPRM Comment #1835); Acton (NPRM Comment
#2070); Dunbar (NPRM Comment #2652); Capuano (NPRM Comment #2722);
Muckley (NPRM Comment #2768); Taravella (NPRM Comment #2892);
Martinez (NPRM Comment #2894); Ballou (NPRM Comment #3331). See also
SNPRM, 84 FR at 24671 (recounting comments from dozens of consumers
complaining that they were denied their prescriptions). \103\ FCLCA, 15 U.S.C. 7601(a)(1).
---------------------------------------------------------------------------
b. Lack of Consumer Complaints as Evidence of Compliance Some commenters reiterated the argument--raised and discussed in
some detail in the SNPRM \104\--that the lack of consumer complaints to
the FTC about prescriber non-compliance is evidence that prescribers
are releasing prescriptions as required.\105\ In the SNPRM, the
Commission explained that it did not equate the lack of complaints with
compliance because based on its experience, the vast majority of
injured or impacted consumers do not register complaints with the
government and, for various reasons, even fewer are likely to file a
formal complaint about a prescriber's failure to release their
prescription.\106\ The Commission also noted that more than fifty
consumers submitted comments to the NPRM recounting personal stories of
prescribers withholding their prescriptions, yet none of these
commenters had previously registered complaints with the FTC.\107\
--------------------------------------------------------------------------- \104\ SNPRM, 84 FR at 24674-75. \105\ Letter from Sens. Jack Reed and Sheldon Whitehouse (SNPRM
Comment #6); Mass Mail Campaign (SNPRM Comment #25); Hanian (SNPRM
Comment #27); Letter from 20 U.S. Senators (SNPRM Comment #38);
Letter from Sen. Lisa Murkowski (SNPRM Comment #49); Levinson (SNPRM
Comment #73); Cinalli (SNPRM Comment #93). \106\ SNPRM, 84 FR at 24674-75. \107\ Id. at 24675.
--------------------------------------------------------------------------- In response, the AOA commented that if complaints to the FTC are
not a good bellwether of prescriber compliance because consumers are
unlikely to file formal complaints, the FTC should simplify and improve
its complaint-reporting system.\108\ The AOA deemed it unfair for the
Commission to rely on consumer survey data as evidence of prescribers'
failure to release prescriptions, but not rely on the absence of
consumer complaints as evidence that prescribers are automatically
providing prescriptions.\109\ The AOA stated the Commission should make
an effort to make consumer complaint data--or lack thereof--more
representative by providing a dedicated FCLCA complaint line for
contact-lens-related issues.\110\ At the same time, however, the AOA
stated that since ``it is very typical'' for patients to ask for their
prescription before their contact lens fitting is complete, consumer
complaints cannot necessarily be viewed as accurate indications of non-
compliance.\111\
--------------------------------------------------------------------------- \108\ American Optometric Association (SNPRM Comment #96). \109\ Id. \110\ Id. \111\ Id.
--------------------------------------------------------------------------- The Commission does not find these arguments persuasive. As noted
in the SNPRM, the Commission has gleaned, through its extensive
experience with consumer complaints and deceptive practices, that the
vast majority of injured or impacted consumers do not file complaints
with the government.\112\ And with the exception of the Telemarketing
Sales Rule (often referred to as ``Do Not Call''), consumer complaints
about FTC rule violations are rarer still, perhaps because they require
that consumers know what an FTC rule specifies and how it has been
violated.\113\ While the Commission continues to regard consumer
complaints as valuable and informative, they often represent the tip of
the iceberg.
--------------------------------------------------------------------------- \112\ SNPRM, 84 FR at 24675. Consumer reticence to complain,
particularly to a government entity, is well documented. As one
example, an FTC survey revealed that in 2017 there were an estimated
61.8 million incidents of fraud in the United States with
approximately 40 million individual victims and average losses of
$100 or more, yet the FTC received just 1.2 million complaints of
fraud from consumers, approximately 1.9% of all incidents. Keith B.
Anderson, FTC, ``Mass Market Consumer Fraud in the United States, A
2017 Update,'' 24, 56 (Oct. 2019); FTC, ``Consumer Sentinel Network
Data Book 2017,'' Number of Reports by Type, https://www.ftc.gov/site-information/open-government/data-sets#csn. It is likely these
figures actually overstate the percentage of frauds reported to the
FTC, since the FTC's fraud surveys are limited to specific types of
fraud, while there is no such limitation on complaints of fraud from
consumers. See also Keith B. Anderson, FTC, ``Consumer Fraud in the
United States: An FTC Survey'' 80 (2004), http://www.ftc.gov/reports/consumer-fraud-united-states-ftc-survey, (indicating that
only 8.4% of U.S. fraud victims complained to an official source,
with only 1.4% complaining to the FTC); Marc A. Grainer et al.,
``Consumer Problems and Complaints: a National View,'' 6 Advances in
Consumer Res. 494 (1979) (noting that ``only a small, vocal minority
of consumers complain about the problems they experience,'' and even
fewer (less than 10% of complaints) complain to the government),
http://acrwebsite.org/volumes/9603/volumes/v06/NA-06; John Goodman &
Steve Newman, ``Understand Customer Behavior and Complaints,''
Quality Progress, Jan. 2003, at 51 (finding that for problems that
resulted in a relatively minor inconvenience or a small loss of
money, only 3% of consumers complained), http://web.ist.utl.pt/
~ist11038/CD_Casquilho/PRINT/qp0103goodman.pdf. \113\ See generally, FTC, ``Consumer Sentinel Network Data Book
2017,'' Number of Reports by Type, https://www.ftc.gov/site-information/open-government/data-sets#csn. FTC, ``Consumer Sentinel
Network Data Book for January-December 2016'' (2017), https://www.ftc.gov/system/files/documents/reports/consumer-sentinel-network-data-book-january-december-2016/csn_cy-2016_data_book.pdf.
--------------------------------------------------------------------------- Furthermore, for reasons discussed in detail in the NPRM, the
Commission does not believe its complaint-reporting system bears
principal responsibility for the shortage of complaints about
prescriber violations of the Contact Lens Rule.\114\ While the FTC does
not have a dedicated complaint system solely for FCLCA violations, as
sought by the AOA, the FTC Complaint Assistant is configured to capture
and report all contact lens-related complaints, whether they originate
from consumers, prescribers, sellers, or others.\115\
--------------------------------------------------------------------------- \114\ NPRM, 81 FR at 88554-55. \115\ The Commission also notes that if, as the AOA asserts,
some consumers would complain that they did not receive their
prescriptions before they were, in fact, entitled to them, creating
a dedicated system for FCLCA complaints would not make the number of
complaints any more or less reflective of prescriber compliance.
--------------------------------------------------------------------------- More to the point, multiple surveys have established that a high
percentage of contact lens wearers (46-60%, according to submitted
data) do not realize they are entitled to receive their
prescription,\116\ and thus would not be aware that an incident about
which they should complain had occurred. Many other consumers might be
unaware of where to direct a complaint when they do not receive a
prescription. Even consumers who are aware that they have a right to
their prescription, and know they can file a complaint with the FTC,
may be unlikely to file one if they ultimately receive their
prescription after they have asked their provider for it. From the
consumers' perspective, they have resolved their problem and may
perceive little benefit to themselves from filing a complaint with the
government, even if the method for filing one was more streamlined or
convenient. Consumers may also not want to risk antagonizing their
providers or subjecting them to legal penalties. Thus, for evaluating
Contact Lens Rule compliance, the Commission has considered the low
rate of consumer complaints filed with the FTC's Complaint Assistant,
but remains convinced this is less probative of the
[[Page 50677]]
scope of the problem than other evidence.\117\
--------------------------------------------------------------------------- \116\ SNPRM, 84 FR at 24675. \117\ Consumer surveys may also be more reliable since consumers
questioned at random are less likely to have a personal interest in
stating that they did not receive their prescription.
---------------------------------------------------------------------------
c. Number of Verifications as Evidence of Non-Compliance With the
Automatic Prescription Release Requirement In the SNPRM, the Commission noted that it would accord the number
of verifications less weight than it had in the NPRM as evidence of
prescriber non-compliance out of a recognition that some consumers--
even if in possession of their prescription--may find it easier to type
in their specifications than present a prescription to the seller, and
because some online contact lens sellers do not have a mechanism for
consumers to present their prescriptions.\118\ In its comment to the
SNPRM, the AOA contended that the high number of verifications should
not be accorded any weight at all for those reasons. As additional
support for this contention, the AOA cited internal prescriber
complaint data showing that the percentage of prescriber complaints
about ``problematic verification calls'' has increased from roughly 6%
to 17% in the past four years; it attributed much of this increase to
the emergence of an online seller that does not permit patient
prescription presentation.\119\ According to the AOA, the increase in
complaints about verification, and the high percentage of such
complaints about the online seller, demonstrate that a ``high volume of
verification calls are occurring based on a prescription that was never
written,'' and therefore the number of verification calls is ``simply
not an appropriate measure for assessing contact lens prescription
requirements and should be afforded no weight.'' \120\
--------------------------------------------------------------------------- \118\ SNPRM, 84 FR at 24674. \119\ American Optometric Association (SNPRM Comment #96). \120\ Id.
--------------------------------------------------------------------------- The Commission is aware of the issues raised by the AOA, but still
believes that the high number of verifications is an indication that
many consumers are not receiving their prescriptions from their
prescribers. While a few new online sellers do not permit prescription
presentation, these sellers' share of the overall contact lens sales is
still quite small, even if their share of prescriber complaints,
according to the AOA, is disproportionately large.\121\ Sellers with
far greater sales, such as 1-800 CONTACTS and Walmart, actively
encourage consumers to present their prescriptions, and 1-800 CONTACTS
has even at times offered consumers discounts for doing so, because it
is faster and less expensive than verification.\122\ Yet despite that
encouragement, roughly 73% of overall sales by third-party sellers
continues to occur via verification.\123\ Therefore, while the
Commission will accord the high number of verifications less weight
than it did in the NPRM, the Commission cannot dismiss its significance
altogether as an indicator that consumers are not always provided their
prescriptions, and will consider it as one of several factors in
weighing the evidence of non-compliance in the record. The Commission
also notes that even if the high number of verifications were
disregarded altogether, the Commission's overall assessment of
prescriber compliance, and the need for Rule modifications, would not
change.
--------------------------------------------------------------------------- \121\ 1-800 CONTACTS accounts for approximately 10% of overall
retail contact lens sales in the United States, and as much as 60-
65% of online sales. The next closest online competitor has less
than a quarter of the sales of 1-800 CONTACTS. See Fed. Trade
Comm'n, The Contact Lens Rule and the Evolving Contact Lens
Marketplace, Panel IV: Examining the Verification Process Tr. at 17
(Mar. 7, 2018), https://www.ftc.gov/system/files/documents/public_events/1285493/panel_iv_examining_the_verification_process.pdf [hereinafter CLR
Panel IV Tr.] (statement of Cindy Williams, 1-800 CONTACTS General
Counsel). Walmart accounts for between 6-10% of all U.S. contact
lens sales. Complaint Counsel's Post-Trial Brief and Exhibits, In
the Matter of 1-800 CONTACTS, 5, (June 22, 2017), https://www.ftc.gov/system/files/documents/cases/d09372ccfindingsoffact.pdf;
Respondent 1-800 CONTACTS Proposed Findings of Fact and Conclusions
of Law, In the Matter of 1-800 CONTACTS, 59 (June 22, 2017), https://www.ftc.gov/system/files/documents/cases/d09372respfindingsoffact.pdf. \122\ National Association of Optometrists and Opticians (SNPRM
Comment #129) (``Because of the cost and time it takes to verify a
prescription when the script is not available, typically an online
seller encourages such uploading and this process aids in consumer
satisfaction and quicker, more accurate service.''); 1-800 CONTACTS
(SNPRM Comment #135) (1-800 CONTACTS encourages its customers to
upload their prescriptions). See also CLR Panel IV Tr., supra note
121, at 6-7 (statement of Jennifer Sommer of Walmart); id. at 6-7,
22 (statement of Cindy Williams of 1-800 CONTACTS). \123\ Paperwork Reduction Act Proposed Collection, Comment
Request, 84 FR at 32171. See also 1-800 CONTACTS (NPRM Comment
#3898) (stating that 70% of online orders require verification).
---------------------------------------------------------------------------
2. Comments About the Need To Improve the Commission's Ability To
Monitor Compliance and Enforce the Rule Several commenters focused on the need to create an auditable
record that would enable the Commission to monitor compliance and
better enforce the automatic-release provision.\124\ One commenter, the
Coalition for Contact Lens Consumer Choice, stated the Confirmation of
Prescription Release proposal gives prescribers more leeway to design a
system of confirmation of prescription release, but ``the important
thing is that prescribers are still required to have patients
affirmatively acknowledge release. . . . This is critical to increase
enforcement of the law and to ensure that bad actors are identified
quickly without inconveniencing those who are obeying the law.'' \125\
The commenter Citizen Outreach agreed, stating that the only way to
ensure compliance with automatic release is by requiring consumers to
sign a confirmation, and suggested that failing to require a consumer's
signed confirmation would be a loophole ``large enough for `bad actors'
to drive a truckload of contact lenses through.'' \126\ Likewise, the
Attorneys General of Twenty-Seven States commented that the proposed
Confirmation of Prescription Release modifications ``strengthen the
Commission's ability to verify compliance with the CLR [which] ensures
more contact lens consumers have the necessary information to make
informed decisions, spurring competition and consumer choice.'' \127\
--------------------------------------------------------------------------- \124\ Bosley (SNPRM Comment #58); Coalition for Contact Lens
Consumer Choice (SNPRM Comment #89); National Hispanic Medical
Association (SNPRM Comment #146). \125\ Coalition for Contact Lens Consumer Choice (SNPRM Comment
#89). \126\ Citizen Outreach (SNPRM Comment #78). \127\ Attorneys General of 27 States (SNPRM Comment #139).
--------------------------------------------------------------------------- Other commenters, however, felt that the FTC already has sufficient
mechanisms to enforce the Contact Lens Rule, and should bring
enforcement actions against so-called ``outliers'' who are violating
the Rule, rather than imposing new requirements on all contact lens
prescribers.\128\ Some suggested that the Confirmation of Prescription
Release requirements should be imposed only on those found to be
violating the prescription-release requirement.\129\ ``By refocusing
these ideas as penalties, rather than mandates,'' according to AAO,
``the FTC can ensure that they are not inflicting burdens on
prescribers that have a record of compliance with the prescription
release requirement in the
[[Page 50678]]
CLR.'' \130\ AOA believes that the FTC already has sufficient authority
and investigative tools at its disposal, and suggested the Commission
could use its ability to issue administrative subpoenas to investigate
prescribers who might be violating the Rule.\131\ One prescriber also
commented that he was skeptical that prescribers who currently
disregard the prescription-release requirement would comply with the
confirmation requirement,\132\ a concern previously raised and
discussed in the SNPRM.\133\
--------------------------------------------------------------------------- \128\ Mass Mail Campaign (SNPRM Comment #25); Ohio Optometric
Association (SNPRM Comment #47); Hardy (SNPRM Comment #60) (``Is it
a fair idea to punish 100% of optometrists and ophthalmologists for
the actions of a fraction of 1%''); American Optometric Association
(SNPRM Comment #96); American Academy of Ophthalmology (SNPRM
Comment #136) (practices will have to comply with the new burdens
even if they have complied with prescription-release for over a
decade). \129\ American Optometric Association (SNPRM Comment #96);
American Academy of Ophthalmology (SNPRM Comment #136). \130\ American Academy of Ophthalmology (SNPRM Comment #136).
The AAO suggested that the acknowledgment and record-keeping
provisions should be imposed on prescribers who have had multiple
complaints, and whose non-compliance was verified after allowing
prescribers an avenue to respond and defend themselves. \131\ American Optometric Association (SNPRM Comment #96). \132\ Steinemann (SNPRM Comment #138). \133\ SNPRM, 84 FR at 24676, 24681.
--------------------------------------------------------------------------- Some commenters also criticized the FTC for, in their words, trying
to acquire new authority to target small and mid-sized businesses, and
stated this ran counter to the current trend for Congress and other
federal agencies to ``recognize the need to alleviate the
administrative burden that federal programs place on physician
practices.'' \134\ And several commenters asserted that the Commission
should not focus on enforcing requirements against prescribers while
contact lens sellers, in their view, are violating Rule provisions in
far greater numbers.\135\
--------------------------------------------------------------------------- \134\ American Society of Cataract and Refractive Surgery (SNPRM
Comment #127). See also Letter from 20 U.S. Senators (SNPRM Comment
#38); Letter from Sen. Lisa Murkowski (SNPRM Comment #49). \135\ McManus (SNPRM Comment #18); Ulrich (SNPRM Comment #19)
(FTC is punishing the wrong actors); Gilberg (SNPRM Comment #46);
American Optometric Association (SNPRM Comment #96); American
Academy of Ophthalmology (SNPRM Comment #136).
--------------------------------------------------------------------------- After considering these comments, the Commission continues to
believe that some form of retained documentation is necessary to
improve the Commission's enforcement and monitoring ability. As
previously noted, the Commission currently faces challenges in
enforcing the Rule. Prescribers, whether intentionally or not,
currently can fail to release prescriptions yet risk little because
consumers are unlikely to file a complaint if they ask for and
subsequently receive a prescription. When a consumer does complain to
the FTC, typically the only evidence is the word of the consumer
against that of the prescriber, making it difficult for the Commission
to establish with a degree of certainty whether a violation has
occurred. This fact has played a significant role in the lack of Rule
enforcement against prescribers over the last fifteen years, and may be
a contributing factor to the high number of contact lens patients who
do not currently receive their prescriptions automatically as required
by law. While the AOA suggests that the Commission can use its current
authority to issue administrative subpoenas and conduct investigative
hearings to explore possible Rule violations, an examination of a
prescriber's Confirmation of Prescription Release records allows a much
more efficient means of determining whether a prescriber is complying
with the Rule, and is much less disruptive and burdensome for the
prescriber.\136\
--------------------------------------------------------------------------- \136\ Serving administrative subpoenas on a wide-scale basis to
prescribers who might not be releasing prescriptions, and requiring
that a prescriber identify all of her contact lens customers for the
last several months so they could be interviewed, would likely be
criticized as excessive and heavy-handed.
--------------------------------------------------------------------------- As for the assertion that prescribers who do not currently comply
with prescription release are unlikely to comply with the confirmation
requirement, the difference is that in the latter instance, there would
be a way to check compliance. If the Commission has concerns about a
prescriber's compliance, it can request patient confirmations or proof
of digital delivery, or a sample of such, which should resolve most
questions as to whether the prescriber provided prescriptions in
accordance with the law. In this way, it would benefit prescribers
because they would have a relatively quick and inexpensive way to show
the FTC they complied with their automatic-release obligations. Further, the Commission is not attempting to expand its authority
to target small businesses. The Commission already possesses the
authority under the FCLCA to enforce the Rule for all contact lens
prescribers, large and small. The Commission's Final Rule institutes a
more effective mechanism for enforcing and evaluating the authority it
already has. And while the Commission recognizes the need to avoid
unnecessary government regulations, the Rule itself is, as one
commenter put it, ``deregulatory'' in nature since its purpose is to
restore free market competition, not to rein it in.\137\ If the Rule,
as currently applied and enforced, is failing to meet this
congressionally mandated goal in some respects, it is the duty of the
Commission to find a more effective manner to realize that purpose.
--------------------------------------------------------------------------- \137\ National Taxpayers Union (SNPRM Comment #149).
--------------------------------------------------------------------------- With regard to the argument that it is unjust to focus on enforcing
the automatic-release provision while not enforcing regulations that
apply to sellers, the Commission does not agree with this premise. The
Commission is aware of complaints about seller misconduct and is
implementing several changes in this Final Rule to improve seller
compliance. The Commission has also brought enforcement actions against
sellers for violating the Rule and expects it will bring others in the
future.\138\ Moreover, seller non-compliance does not excuse prescriber
non-compliance, nor does it provide a justification for the Commission
to reject taking action to improve compliance with a different
requirement in the Rule.
--------------------------------------------------------------------------- \138\ See, e.g., U.S. v. Duskin, No. 1:18-cv-07359 (N.D. Cal.
Dec. 6, 2018) (consent) U.S. v. Kim, No. 1:11-cv-05723 (E.D.N.Y. Feb
7, 2012) (consent); U.S. v. Royal Tronics, Inc, No. 0:11-cv-62491
(S.D. Fla. Jan. 27, 2012) (consent); U.S. v. Thy Xuan Ho, No. 1:11-
cv-03419 (D. Minn. Dec. 27, 2011) (consent); U.S. v. Gothic Lens,
LLC, No. 1:11-cv-00159 (N.D. Ga. Feb. 3, 2011) (consent); U.S. v.
Jokeshop, LLC, No. 1:11-cv-11221 (D. Mass. Nov. 29, 2011) (consent);
U.S. v. Contact Lens Heaven, Inc., No. 0:08-cv-61713 (S.D. Fla. Dec.
3, 2008) (consent); U.S. v. Chapin N. Wright, II, No. 1:08-cv-11793
(D. Mass. Oct. 31, 2008) (consent); U.S. v. BeWild, Inc., No. 2:07-
cv-04896 (E.D.N.Y. Dec. 3, 2007) (consent); U.S. v. Pretty Eyes,
LLC, No. 1:07-cv-02462 (D. Colo. Nov. 28, 2007) (consent); U.S. v.
Walsh Optical, Inc., No. 2:06-cv-03591 (D.N.J. Aug. 30, 2006)
(consent); see also FTC Sends Warning Letters to Sellers of Cosmetic
Contacts: All Contact Lens Purchases Require a Prescription from a
Medical Professional, https://www.ftc.gov/news-events/press-releases/2019/10/ftc-sends-warning-letters-sellers-cosmetic-contacts-all-contact; FTC Issues Warning Letters Regarding the
Agency's Contact Lens Rule, https://www.ftc.gov/news-events/press-releases/2016/04/ftc-issues-warning-letters-regarding-agencys-contact-lens-rule.
---------------------------------------------------------------------------
3. Comments About Whether the Structure of the Contact Lens Market
Creates a Need for Verifiable Enforcement of Automatic Prescription
Release Many SNPRM commenters focused on the structure of the contact lens
market and whether a system in which prescribers sell the items they
prescribe creates an inherent conflict that requires additional
corrective action by the Commission.\139\ U.S. Senator Ron Wyden, for
example, commented that
[[Page 50679]]
Congress passed the FCLCA ``to address a distorted contact lens
marketplace that had seen freedom of choice eroded as prescribers
largely sold the contact lenses they prescribed,'' \140\ and another
commenter wrote, ``The system here in the U.S. for buying contact
lenses is stacked against consumers because the people who issue you
your prescription are also allowed to sell you contact lenses at the
very same time. Consumers who don't know their rights are getting
`trapped in the exam chair' so to speak, unaware that they can buy
lenses elsewhere for lower prices.'' \141\ According to the Information
Technology & Innovation Foundation, which describes itself as a
nonpartisan research and educational institute, ``the profession has
both a powerful economic interest (profits) and a powerful tool (the
prescription) to make it more difficult for consumers to buy their
lenses from lower-cost providers.'' \142\ In fact, a number of
commenters support the Commission's proposal because, while regulatory
in nature, it is designed to promote free market competition and
protect consumers' ability to purchase from the seller of their
choice.\143\ One commenter wrote that the only solution to what she
termed ``the inherent structural problem that continues to cause
friction between providers and patients'' is to prohibit prescribers
from selling contact lenses.\144\
--------------------------------------------------------------------------- \139\ Citizen Outreach (SNPRM Comment #78) (prescribers' ability
to sell what they prescribe ensures a ``captive market''); Lens.com
(SNPRM Comment #85) (``the current system is rigged against
consumers and companies who compete with prescribers''); Coalition
for Contact Lens Consumer Choice (SNPRM Comment #89); Taxpayers
Protection Alliance (SNPRM Comment #118); Information Technology &
Innovation Foundation (SNPRM Comment #103); National Hispanic
Medical Association (SNPRM Comment #146). \140\ Letter from Sen. Ron Wyden (SNPRM Comment #5); see also
Taxpayers Protection Alliance (SNPRM Comment #118) (``Congress
passed the bipartisan Fairness to Contact Lens Consumers Act to
protect contact lens wearers. The result was less market distortion
and more competition, leading to more choices and lower prices for
consumers.''). \141\ National Hispanic Medical Association (SNPRM Comment
#146). \142\ Information Technology & Innovation Foundation (SNPRM
Comment #103). \143\ See Americans for Tax Reform (SNPRM Comment #72) (``These
changes strike the correct balance between promoting the free market
and protecting important consumer rights.''); Citizen Outreach
(SNPRM Comment #78); Taxpayers Protection Alliance (SNPRM Comment
#118) (``Although we are often critical of government overreach and
work hard to make government smaller, we believe that the FTC's
proposed Contact Lens Rule is a government rule that works for
taxpayers and consumers.''); National Taxpayers Union (SNPRM Comment
#149) (``From the perspective of free-market, limited government
advocates, the Contact Lens Rule has been one of the most balanced
and successful examples of `deregulatory rulemaking' in the FTC's
history.''). \144\ Carafas (SNPRM Comment #39).
--------------------------------------------------------------------------- The AOA, on the other hand, disputes the premise that the contact
lens market is unique, and argues that the fact that prescribers sell
what they prescribe does not create an impetus for corrective
regulation.\145\ According to the AOA, health care professionals in
certain other areas--such as ambulatory surgery centers, orthopedic
centers, and dental service providers, among others--also sell what
they prescribe or recommend for treatment. Furthermore, according to
the AOA, helping patients ``obtain treatment while in their doctor's
office builds strong doctor-patient relationships and promotes patient-
centered care.'' \146\ The AOA therefore concludes that ``the
Commission seems to have used the inaccurate belief that contact lens
prescribers' role in the market is entirely unique as a justification
for implementing new regulations on physicians,'' and thus, ``the
entire argument for supporting prescriber rule changes must be
reevaluated.'' \147\
--------------------------------------------------------------------------- \145\ American Optometric Association (SNPRM Comment #96). \146\ Id. \147\ Id.
--------------------------------------------------------------------------- Several commenters also felt that the contact lens market is
functioning properly, as evidenced by the relatively large number of
contact lens sellers, and by lens prices that appear competitive, and
thus there is no need for FTC intervention to modify the Rule.\148\ As
support for this position, the AOA submitted a price-comparison
analysis that it stated showed that the average price difference for
contact lenses between online sellers and office prescribers was just
thirty-two cents.\149\ According to the AOA, this demonstrates that the
market is highly competitive, and thus the FCLCA and Rule are working
as intended and, consequently, there is no need for Rule modification
and a Confirmation of Prescription Release.\150\
--------------------------------------------------------------------------- \148\ Warner (SNPRM Comment #9); Ohio Optometric Association
(SNPRM Comment #47); Cutter (SNPRM Comment #81); American Optometric
Association (SNPRM Comment #96). \149\ American Optometric Association (SNPRM Comment #96). \150\ Id.
--------------------------------------------------------------------------- The Commission does not share this assessment. While there are now
a number of different types of sellers, and the market has become more
competitive than it was before the Rule,\151\ prescribers still possess
a significantly higher share of contact lens sales than online sellers,
mass merchandisers, or retail chains,\152\ even though prescriber
prices, on the whole, are consistently higher.\153\ The AOA's
assessment appears to be based on lens price per-packet, rather than
per-day or per-year.\154\ The Commission does not believe per-packet
pricing is a fair method of comparison, because it compares some lenses
that are effectively sold in a multi-month supply with lenses that are
only sold as a single month's supply. The Commission conducted a re-
analysis of the AOA's data by aggregating to a consistent time-frame in
order to compare what consumers might actually spend to wear lenses on
a regular basis. This re-analysis--using the data supplied by AOA--
determined that the average annual prices of contacts were from $9 to
$40 more expensive if purchased from a private practice than from the
leading online seller.\155\ The price difference for an annual supply
of lenses was even starker between a private practitioner and a leading
mass merchandiser, with private practitioners averaging between $62 and
$92 more for an annual supply.\156\ Likewise, at the Commission's
Contact Lens Workshop, an eye care consultant presented a price survey
for sixteen leading contact lens brands and concluded that an annual
supply of lenses purchased online
[[Page 50680]]
averaged $17.56 less than at an independent prescribers' office, and
lenses purchased from a shopper's club averaged $42.44 less.\157\
--------------------------------------------------------------------------- \151\ CLR Panel I Tr., supra note 100, at 3-5 (remarks of Steve
Kodey and accompanying slides, U.S. Optical Market Overview). \152\ Approximately 39% of all contact lenses sales revenue in
the U.S. occurs at independent eye care professionals, compared to
18% at conventional chains, 25% at mass merchants and wholesale
clubs, and 16% online. Vision Council, U.S. Optical Market Eyewear
Overview 4 (2018), https://www.ftc.gov/sites/default/files/filefield_paths/steve_kodey_ppt_presentation.pdf. It is also worth
noting that while the contact lens retail market has evolved since
2004, it may well have changed less dramatically than many other
retail industries have since the internet revolution began diverting
sales from brick and mortar to online merchants. \153\ See CLR Panel I Tr., supra note 100, at 9 (remarks of
Wallace Lovejoy and accompanying slides, Contact Lens Price Ranges
By Sales Channel); see also Opinion of the Commission, In the Matter
of 1-800 CONTACTS, 4 (``Among brick-and-mortar retailers,
independent ECPs typically have the highest prices for contact
lenses . . . .''), https://www.ftc.gov/system/files/documents/cases/docket_no_9372_opinion_of_the_commission_redacted_public_version.pdf. \154\ The Commission has not been able to precisely replicate
the thirty-two-cent-difference figure stated by AOA. But by
comparing average packet prices in the data supplied, the difference
between private practices and online sellers is 35 cents. For the
reasons stated, however, the Commission does not believe this figure
is an appropriate comparison measure. \155\ The average depends on whether a consumer purchased an
annual supply all at once (in which case they received a discount
from the online retailer) or in individual package increments. The
Commission also notes that prices at the ``Leading Online
Retailer,'' which, based on sales and market share, could be 1-800
CONTACTS, might not represent the average online price for contact
lenses, and prices at 1-800 CONTACTS, by its own admission, are
typically higher than those of both other online sellers and retail
club stores. Brief of 1-800 CONTACTS, 1-800 CONTACTS v. Federal
Trade Commission (2d Cir. June 12, 2019); see also Opinion of the
Commission, In the Matter of 1-800 CONTACTS, 4, https://www.ftc.gov/system/files/documents/cases/docket_no_9372_opinion_of_the_commission_redacted_public_version.pdf. \156\ The data derives from the ABB Optical Group, Soft Lens
Retail Price Monitor (First Quarter 2019). \157\ CLR Panel I Tr., supra note 100, at 9 (remarks of Wallace
Lovejoy and accompanying slides, Contact Lens Price Ranges By Sales
Channel).
--------------------------------------------------------------------------- There can be valid reasons for differences in prices among sellers
(some sellers may offer more convenience, options, or better customer
service), and the Commission does not view price differences between
private eye care practitioners and third-party sellers, in and of
itself, as dispositive evidence that the market is not functioning in a
competitive manner. But the Commission disagrees that the submitted
pricing data is proof that the market is functioning in a perfectly
competitive manner, and is proof that prescribers are providing
patients with their prescriptions. The Commission is also aware that there are other health care
professionals who may sell what they prescribe or recommend for
treatment, and has not based its proposal solely on a belief that
contact lens prescribers' role and market is unique. Rather, the
Commission has considered the structure of the market as a contributing
factor in an overall evaluation of the need for improved Rule
compliance and enforcement. It must be acknowledged--as it was by
Congress when it enacted the FCLCA and directed the FTC to implement
the Rule--that it is not in prescribers' self-interest for their
patients to take prescriptions elsewhere to buy lenses.\158\ And while
it is true that some health care professionals in other fields sell
products that they prescribe or recommend for treatment, the sheer
volume of contact lens prescribers' revenue and profit derived from the
sale of contact lenses--16-32% of revenue, by some accounts \159\--
creates a powerful incentive to keep those sales in house.
--------------------------------------------------------------------------- \158\ See H.R. Rep. No. 108-318, at 4-5 (stating that ``[t]he
practice of optometrists withholding the prescription has limited
the consumer's ability to shop for the best price and has impacted
competition'' and that obstacles to free market competition are
rooted in an ``inherent conflict of interest'' in that ``[u]nlike
medical doctors who are prohibited from selling the drugs they
prescribe, eye doctors and optometrists . . . are able to fill the
contact lens prescriptions they write''); see also 149 Cong. Rec.
H11564-65 (daily ed. Nov. 19, 2003) (statement of Rep. Stark) (``Eye
doctors cite health concerns, but the fact is they have a strong
financial incentive to restrict consumer access to the contact lens
market.''). \159\ Harris Williams & Co., Vision Industry Update, at 4 (Mar.
2017); Harris Williams & Co., Vision Industry Overview, at 3 (Jan.
2015). Contact Lens Spectrum has estimated the percentage of gross
practice revenue from contact lenses to be 30%, and the net practice
revenue at 26%, but the estimate does not specify how much of that
was derived from sales of lenses versus professional fees for
contact lens fittings and examinations. Contact Lens Spectrum, at 19
(Jan. 2019), https://bt.editionsbyfry.com/publication/frame.php?i=552776&p=&pn=&ver=html5. See also Ken Kriviac, How to
Hubble-Proof Your Contact Lens Practice, Review of Optometric
Business (Jan. 17, 2018) (optometrist stating that 17% of his
practice's total revenue is generated from the sale of contact lens
related materials, with another 8% from related professional fees),
https://reviewob.com/can-hubble-proof-contact-lens-practice/.
---------------------------------------------------------------------------
4. Comments About the Text of the Proposed Confirmation of Prescription
Release, and the Options To Include the Confirmation as Part of a
Patient's Prescription or Sales Receipt As noted previously, unlike the two-sentence signed-acknowledgment
proposal from the NPRM,\160\ the SNPRM's Confirmation of Prescription
Release proposal did not mandate specific text for the patient's signed
confirmation. Instead, the SNPRM, for convenience, provided optional
sample language that prescribers could use but left it up to individual
prescribers to draft their own confirmation language if they so
preferred.\161\ The Commission proposed this flexibility in response to
commenter concerns that the language of the NPRM's signed-
acknowledgment interfered with the prescriber-patient relationship by
imparting the impression that prescribers had done something wrong. By
permitting prescribers to draft their own confirmation language or use
the provided, shortened sample language, the Commission aimed to allow
prescribers to use wording that they believe would be less likely to
reflect negatively on the prescribers' conduct.\162\ The Commission
also proposed to allow prescribers to include the confirmation as part
of a patient's prescription or sales receipt.\163\
--------------------------------------------------------------------------- \160\ NPRM, 81 FR at 88559. \161\ SNPRM, 84 FR at 24683. The sample language provided by the
Commission consisted of the following: ``My eye care professional
provided me with a copy of my contact lens prescription at the
completion of my contact lens fitting.'' \162\ Id. \163\ Id.
--------------------------------------------------------------------------- One commenter, the National Association of Optometrists and
Opticians (``NAOO''), praised the new options and flexibility, stating
it would ``assist the industry in, and lighten the burdens of,
compliance.'' \164\ The NAOO also approved of the FTC sample
confirmation language, calling it a ``concise statement of the point of
the Rule,'' and predicting it would be used by most of its
members.\165\ The NAOO did suggest, however, that to avoid potential
confusion from a confirmation statement containing additional
acknowledgments or unnecessary information, the Rule should clarify
that the patient's confirmation statement should not contain any
message or acknowledgment other than that relating to confirmation of
prescription release.\166\ The NAOO also suggested that in instances
where a consumer refused to sign the confirmation, the Commission
should allow the prescriber to note the refusal and the reason for it
as evidence of compliance.\167\
--------------------------------------------------------------------------- \164\ National Association of Optometrists and Opticians (SNPRM
Comment #129). \165\ Id. \166\ Id. \167\ Id.
--------------------------------------------------------------------------- Other commenters felt that even with the new confirmation-language
flexibility, requiring patients to confirm receipt of their
prescriptions would imply that prescribers had been improperly
withholding them.\168\ One prescriber commented, ``Why would I need to
get a signature of my patient to confirm they received a prescription
unless I was doing something wrong that required proof.'' \169\ Others
felt that the requirement still unfairly forced them to aid their
competition by reminding consumers that they could take their
prescriptions to other sellers to have them filled.\170\
--------------------------------------------------------------------------- \168\ Abert (SNPRM Comment #20) (``The additional time required
for this unneeded paperwork would disrupt the patient-doctor
relationship by communicating to the patients that they should be
wary of their physician, and assume that their doctor is a violator
of Federal law.''); Ohio Optometric Association (SNPRM Comment #47)
(``The proposal, even in its latest form, will . . . cast public
doubt on the integrity of the optometrists and ophthalmologists . .
. .''); Cutter (SNPRM Comment #81); Ritzel (SNPRM Comment #157)
(``The idea of me having to have a patient sign a form certifying
that I actually gave them a copy of their contact lens
prescription--because ``Big Brother'' is watching--is insulting to
myself as a person, and to my profession.''). \169\ Cutter (SNPRM Comment #81). \170\ Sanders (SNPRM Comment #61) (``It's akin to having Target
have a big sign next to their own that states, `You can get
everything here at Walmart as well!' ''); Poulter (SNPRM Comment
#131) (``It is no more necessary for providers to inform patients of
their right to purchase elsewhere than it is for a dentist to let a
patient know he can purchase a crown from another party, then return
to the dentist to have it placed.'').
--------------------------------------------------------------------------- In contrast, some commenters felt that allowing prescribers to
draft their own language, and removing the second sentence of the
acknowledgment (the requirement that patients confirm the statement:
``I understand I am free to purchase contact lenses from the seller of
my choice''), greatly reduced the effectiveness of the new
proposal.\171\ The online seller 1-800 CONTACTS, in particular,
asserted that removal of the second sentence significantly reduced the
educational benefit of the
[[Page 50681]]
requirement since consumers who were unaware they had a right to their
prescription would not be so informed. 1-800 CONTACTS also stated that
eliminating the second sentence made it less likely prescribers would
release prescriptions directly after the fitting is complete, and
prescribers would instead wait until patients had purchased lenses
before giving them their prescriptions and obtaining Confirmations of
Prescription Release.\172\ 1-800 CONTACTS also said there is no reason
the second sentence would ``sow consumer doubt or harm prescribers'
reputations'' unless the prescriber had previously been withholding
prescriptions.\173\ The online seller therefore proposed that instead
of leaving the wording up to prescribers, the confirmation requirement
should again specify the wording required and include the second
sentence from the acknowledgment proposal--albeit with a minor
adjustment--so as to state, ``I understand that I am free to purchase
contact lenses from my eye care professional or the seller of my
choice.'' \174\ Inclusion of the option to purchase from the ``eye care
professional'' might alleviate some concern that the notice was
instructing consumers to buy from someone other than their prescriber.
--------------------------------------------------------------------------- \171\ Consumer Reports (SNPRM Comment #133); 1-800 CONTACTS
(SNPRM Comment #135). \172\ 1-800 CONTACTS (SNPRM Comment #135) (According to a survey
conducted by an independent polling firm on behalf of 1-800
CONTACTS, 38% of consumers who are given their prescription receive
it at the same time or only after they have already purchased lenses
from the prescriber). \173\ Id. (``Because the Confirmation does not require that
prescribers provide consumers with any notice of their rights, but
merely requires that consumers acknowledge receipt by signature, it
is far less likely to either educate consumers or discourage
prescribers from pressuring consumers into buying lenses.''). \174\ 1-800 CONTACTS (SNPRM Comment #135).
--------------------------------------------------------------------------- The consumer advocacy organization Consumer Reports also opposed
permitting prescribers to devise their own language of confirmation,
and opposed allowing prescribers to make the confirmation part of a
prescription copy or sales receipt (Confirmation of Prescription
Release options (B) and (C)).\175\ Instead, Consumer Reports stated
that the confirmation should remain a stand-alone document, and
suggested requiring the statement, ``My eye care professional provided
me with a copy of my contact lens prescription at the completion of my
contact lens fitting. I should give a copy of my prescription to the
contact lens seller I choose.'' \176\ According to Consumers Reports,
there are ``clear advantages to standardized wording,'' and by
instructing consumers to present their prescription to sellers, this
would further promote the Commission's goal of reducing
verifications.\177\ Consumer Reports opined that a statement of
confirmation added to the prescriber's copy of the prescription, or
added to an examination receipt, might not be noticed by the
patient.\178\
--------------------------------------------------------------------------- \175\ Consumer Reports (SNPRM Comment #133). \176\ Id. \177\ Id. \178\ Id.
--------------------------------------------------------------------------- Some commenters also opined that when prescribers satisfy the
confirmation by releasing the prescription electronically (option (D)),
prescribers should still provide consumers with a statement advising
them that they have a right to their prescription and have the option
to buy lenses elsewhere.\179\ And many commenters raised concerns about
whether to allow option (D) altogether, as discussed in more detail
below.
--------------------------------------------------------------------------- \179\ Id.; 1-800 CONTACTS (SNPRM Comment #135).
--------------------------------------------------------------------------- With respect to allowing options (B) and (C), and permitting
prescribers to craft their own wording, the Commission acknowledges
that the confirmation proposal may provide less of an immediate
educational benefit than the NPRM's proposed Signed Acknowledgment. By
permitting prescribers to include the confirmation on the prescription
itself, or on a sales receipt, it is indeed possible that some
consumers will fail to understand its purpose, or what it is they are
signing. And by not requiring that the confirmation include a sentence
specifically informing consumers of their right to have prescriptions
filled elsewhere, and not requiring a notice to this effect with
digital delivery, some consumers may remain unaware of prescription
portability. The Commission, however, continues to believe that the benefit from
providing prescribers with greater flexibility, reducing the possible
paperwork burden, and limiting potential interference with the
prescriber-patient relationship, justifies the trade-off. As noted in
the SNPRM, the Confirmation of Prescription Release will maintain much
of the effectiveness and enforceability of the Signed Acknowledgment,
while reducing the impact on prescribers.\180\
--------------------------------------------------------------------------- \180\ SNPRM, 84 FR at 24683.
--------------------------------------------------------------------------- The Commission also does not believe that requiring patients to
sign a confirmation will provoke doubts about the integrity of their
prescribers. While patients might draw the conclusion that some
prescribers have not always automatically released prescriptions, there
is little reason for patients to conclude that their individual
prescriber had failed to do so, especially if their prescriber has
always provided them with their prescription. It seems more likely that
patients may simply conclude that the law has changed. Furthermore, as
noted in the SNPRM, consumers are accustomed to signing acknowledgments
or receipts. Many pharmacists require patients to acknowledge that they
do not have questions upon receiving a prescription; physicians'
offices require visitors to sign in; and patients are accustomed to
signing HIPAA acknowledgment forms signifying they received a
provider's Notice of Privacy Practices.\181\ The Commission is not
aware of any evidence that such requirements sow distrust on the part
of the person signing the receipt. The Commission believes this will
hold true for the Confirmation of Prescription Release, particularly
since prescribers can devise their own language of confirmation. The
Commission also believes that while it may be advisable for providers
to avoid potential patient confusion by not including any other
acknowledgments or information on the confirmation document, it is not
necessary to expressly prohibit this in the Rule at this time. Such a
prohibition might limit the flexibility of the new proposal, and could
make it more difficult for providers to avail themselves of options (B)
and (C) by including patient confirmation as part of a sales receipt or
prescription copy. Moreover, as noted in the SNPRM, while prescribers
are free to provide their own language, it would remain a violation for
the receipt to include additional information proscribed by the Rule,
such as liability waivers or agreements to purchase lenses from the
prescriber.\182\
--------------------------------------------------------------------------- \181\ Id. at 24682. \182\ Id. at 24683.
---------------------------------------------------------------------------
5. Comments About Option (D) and Using Electronic Delivery for
Confirmation of Prescription Release In the SNPRM, the Commission proposed modifying the Rule to allow
prescribers to satisfy the automatic prescription release requirement
by providing a digital copy in lieu of a paper copy when the patient
gives verifiable affirmative consent.\183\ The Commission noted that
using online patient portals and other electronic methods to complete
the automatic prescription release offered potential benefits for
sellers, prescribers, and patients.\184\ Patients would be able to
[[Page 50682]]
access their prescriptions and have electronic copies to send to
sellers. With the prescription, a seller would no longer need to submit
a verification request, which would benefit prescribers by reducing the
volume of requests. However, there were also some concerns about
portals, including that patients may not be aware of the portal or have
difficulty accessing it.\185\ Because the Commission did not have
sufficient information to determine whether solely posting a contact
lens prescription on a patient portal would be sufficient to satisfy
the Rule's obligation for prescribers to provide a copy of the
prescription after completing the contact lens fitting, the Commission
sought comments on its proposed Rule modification.\186\ The Commission
also asked for comments on whether prescribers should be required to
maintain any records documenting a patient's verifiable consent to
receive a prescription electronically.\187\
--------------------------------------------------------------------------- \183\ Id. at 24669. \184\ Id. at 24668. \185\ Id. \186\ Id. at 24669. \187\ Id. at 24690.
---------------------------------------------------------------------------
a. Use of Patient Portals and Patient Consent Many commenters expressed support for allowing prescribers to use
electronic methods, such as a patient portal, to provide prescriptions
to patients who consent.\188\ Among the potential benefits, commenters
noted the reduction in verification calls or requests for additional
copies, easier access to and use of a prescription, lower costs, and
flexibility for patients and prescribers.\189\ Currently, many
prescribers already use a portal or other electronic methods to
communicate with and, in some instances, provide prescriptions to their
patients,\190\ and use of electronic methods is expected to increase in
the future.\191\ For example, one survey found that approximately 64.2%
of eye care professionals communicated with patients by text message,
of which 26.4% used it to respond to personal questions about the
patient's eye health.\192\ Because a significant percentage of eye care
providers already use electronic communications and portals, the
Commission believes that the required, automatic prescription release
could be completed effectively through a digital copy when a patient
provides verifiable affirmative consent. Verifiable affirmative consent
means that a patient must have provided his or her consent to the
prescriber in a way that can be later confirmed. A signed consent form,
an email from the patient to the prescriber, or an audio recording from
a telephone conversation with a patient would be examples of verifiable
affirmative consent. Notification through, for example, a posted office
sign or a general written notice of office policies or practices would
not constitute affirmative consent because patients have not indicated
to the prescriber whether or not they consent.
--------------------------------------------------------------------------- \188\ See, e.g., Liao (SNPRM Comment #2); Coalition for Contact
Lens Consumer Choice (SNPRM Comment #89); Consumer Action (SNPRM
Comment #101); Information Technology & Innovation Foundation (SNPRM
Comment #103); Alcon Vision, LLC (SNPRM Comment #117); National
Association of Optometrists and Opticians (SNPRM Comment #129);
CooperVision, Inc. (SNPRM Comment #130) (noting that electronic
delivery of a prescription is ``a common-sense, low burden method of
giving patients better access to their prescriptions''); 1-800
CONTACTS (SNPRM Comment #135); Attorneys General of 27 States (SNPRM
Comment #139); National Hispanic Medical Association (SNPRM Comment
#146); Backus (WS Comment #1650). \189\ Americans for Tax Reform (SNPRM Comment #72); Coalition
for Contact Lens Consumer Choice (SNPRM Comment #89); Consumer
Action (SNPRM Comment #101); Information Technology & Innovation
Foundation (SNPRM Comment #103); National Association of
Optometrists and Opticians (SNPRM Comment #129); CooperVision, Inc.
(SNPRM Comment #130); Consumer Reports (SNPRM Comment #133). \190\ See, e.g., Coalition for Contact Lens Consumer Choice
(SNPRM Comment #89); American Optometric Association (SNPRM Comment
#96); National Association of Optometrists and Opticians (SNPRM
Comment #129) (stating that practice management systems and
electronic health records are easily available at reasonable
prices); Sikes (SNPRM Comment #114); Klepfisz (SNPRM Comment #140);
Eklund (WS Comment #502); Holland (WS Comment #513); Reed (WS
Comment #749); Gitchell (WS Comment #759); Andrews (WS Comment
#1014); Carvell (WS Comment #1021); Cecil (WS Comment #1892); Kuryan
(WS Comment #3472); Hopkins (NPRM Comment #184); Wilson (NPRM
Comment #1310); Grove (NPRM Comment #1702); MacDonald (NPRM Comment
#2118); Andrus (NPRM Comment #3345). \191\ FTC, The Contact Lens Rule and the Evolving Contact Lens
Marketplace, Panel V: Prescription Release & Consumer Choice Tr. at
18-21 (Mar. 7, 2018), https://www.ftc.gov/system/files/documents/public_events/1285493/panel_v_prescription_release_and_consumer_choice.pdf [hereinafter
CLR Panel V Tr.]. \192\ Jobson Research, ECP Digital Solutions Study (2019) (also
finding that of those surveyed, approximately 74.4% contacted their
patients by email, of which 45.5% used it to respond to personal
questions about the patient's eye health). As noted in the SNPRM,
another survey showed that approximately 30% of patients were
offered access to a portal during their last eye exam and that 29%
chose to use the portal. SNPRM, 84 FR at 24668 n.50.
--------------------------------------------------------------------------- Several commenters supported the use of electronic methods, but had
a variety of concerns or proposed changes. Some thought patients might
prefer a paper copy instead of an electronic copy of their
prescription, including people who are older, reluctant to use
technology or worried about online privacy or identity theft, unable to
navigate a cumbersome portal, without internet or smartphone access, or
not proficient in English.\193\ The Commission shares these concerns
and the Final Rule thus maintains the ability for patients who prefer a
paper copy for any reason to obtain such a copy. Even if a prescriber
offers electronic delivery, a patient could decline to provide consent.
Likewise, prescribers who are concerned about the security or costs of
electronic methods can continue providing paper copies.\194\ The Final
Rule neither compels prescribers to offer prescription release by an
electronic method nor requires that patients accept their prescription
by electronic method when offered by the prescriber.
--------------------------------------------------------------------------- \193\ R Street (SNPRM Comment #15); Americans for Tax Reform
(SNPRM Comment #72); Coalition for Contact Lens Consumer Choice
(SNPRM Comment #89); American Optometric Association (SNPRM Comment
#96); National Hispanic Medical Association (SNPRM Comment #146);
National Taxpayers Union (SNPRM Comment #149). \194\ American Optometric Association (SNPRM Comment #96);
American Society of Cataract and Refractive Surgery (SNPRM Comment
#127).
--------------------------------------------------------------------------- One seller urged the Commission to require that the prescribers,
when seeking affirmative consent, identify to patients the specific
method of electronic delivery that would be used.\195\ The Commission
believes that requiring prescribers to identify the specific method or
methods \196\ would allow patients to make a more informed decision and
increase awareness of how the prescription would be provided if they
were to consent. It is also possible that a patient prefers one method
of electronic communication, but not others.\197\ Therefore, the
Commission is amending the definition of ``Provide to the patient a
copy'' to require that prescribers who choose to offer an electronic
method, identify the specific method or methods to be used and, if a
patient consents, have evidence of verifiable affirmative consent to
the identified method or methods.
--------------------------------------------------------------------------- \195\ 1-800 CONTACTS (SNPRM Comment #135). \196\ A request for consent that states that the prescription
would be delivered electronically, but does not state the method,
such as email, text, or portal, would not be adequate. If more than
one method is offered, prescribers must specifically identify each
one. \197\ 1-800 CONTACTS (SNPRM Comment #135).
--------------------------------------------------------------------------- Regarding patient portals specifically, some commenters expressed
concerns that: (1) Patients would be unaware that their prescription is
on a portal; (2) there could be a delay in posting prescriptions to the
portal; or (3) prescribers might intentionally make portals difficult
to use, post prescriptions without telling their patients, or confuse
patients into thinking that they must buy lenses from
[[Page 50683]]
them.\198\ They urged the Commission to require that prescribers notify
patients when a prescription is available on the portal, provide
instructions on how to access the portal, or confirm that the
prescription has been received.\199\ The Commission believes that the
Final Rule provides adequate safeguards for patients who have opted to
receive their prescription on a portal. As noted in the SNPRM, the use
of a portal or other electronic method does not change the timing of
when a prescriber must provide a copy of the contact lens
prescription.\200\ A prescriber must provide the prescription
immediately after the completion of the contact lens fitting, or in the
case of a renewal, when a prescriber determines that no change to the
existing prescription is required.\201\ Furthermore, prescribers can
only use a portal to satisfy their obligation under Sec. 315.3(a)(1)
when they have affirmative consent to the specific method or methods of
electronic delivery. Therefore, patients should be aware that their
prescription will be provided electronically using the method to which
they consented. The Rule also requires that patients be able to access,
download, and print the prescriptions from the portal.\202\ If patients
were to have any problems with using the portal, they could revoke
their consent and request a paper copy.\203\ Notwithstanding these
safeguards, the Commission encourages prescribers to provide
instructions to patients who may encounter difficulties accessing their
portal. The Commission believes that the Rule, with the modification to
require that prescribers identify the specific electronic method to be
used, balances the interests of prescribers and patients by offering a
flexible method that could reduce the burden on prescribers and allow
patients greater access to their prescriptions.\204\
--------------------------------------------------------------------------- \198\ R Street (SNPRM Comment #15); Lens.com (SNPRM Comment
#85); Coalition for Contact Lens Consumer Choice (SNPRM Comment
#89); Consumer Action (SNPRM Comment #101); Information Technology &
Innovation Foundation (SNPRM Comment #103); 1-800 CONTACTS (SNPRM
Comment #135); National Hispanic Medical Association (SNPRM Comment
#146); Senator Mike Lee (SNPRM Comment #159). \199\ R Street (SNPRM Comment #15); Information Technology &
Innovation Foundation (SNPRM Comment #103); Consumer Reports (SNPRM
Comment #133); 1-800 CONTACTS (SNPRM Comment #135); Senator Mike Lee
(SNPRM Comment #159). \200\ SNPRM, 84 FR at 24669 n.54. \201\ Id. \202\ The Commission does not have any evidence that prescribers
are intentionally making portals difficult for their patients to
use. However, such conduct, if it were to occur, could violate the
Rule because patients would not be able to access their
prescription. \203\ Patients could also request an additional copy under 16
CFR 315.3(a)(3). \204\ Consumer Action appears to encourage the Commission to
provide further guidance on portal design in the Rule. SNPRM Comment
#101. Given the potential for future developments in technology and
the differences among prescribers' practices and current software,
the Commission declines to mandate requirements on portal design.
See CLR Panel V Tr., supra note 191, at 18-21 (discussing the
variety of electronic-health-records programs available from
``hundreds'' of ECH vendors, with each program based on different
standards and providing varying degrees of functionality and
compatibility).
--------------------------------------------------------------------------- Furthermore, some commenters want a paper copy to be provided in
addition to the electronic copy,\205\ but the Commission declines to
adopt this suggestion because requiring both copies would undercut a
benefit of using electronic methods and be unnecessary for patients who
have expressed a preference for an electronic copy. Finally, a
commenter states that telemedicine prescribers should not be required
to provide paper prescriptions.\206\ Although patients who opt for
telemedicine might be more comfortable with technology and receiving
health care online,\207\ some patients may still prefer their
prescription on paper. Since telemedicine providers should have been
providing a paper copy under the current Rule, continuation of this
practice, when a patient does not consent to electronic delivery,
should not be impractical or overly burdensome.
--------------------------------------------------------------------------- \205\ Americans for Tax Reform (SNPRM Comment #72); Lens.com
(SNPRM Comment #85); Coalition for Contact Lens Consumer Choice
(SNPRM Comment #89); Consumer Action (SNPRM Comment #101); Consumer
Reports (SNPRM Comment #133). \206\ Simple Contacts (SNPRM Comment #87). \207\ Id.
---------------------------------------------------------------------------
b. Requirement To Maintain Records of Patient Consent In the SNPRM, the Commission proposed requiring that prescribers
obtain affirmative consent in order to provide a prescription
electronically, but did not require that prescribers maintain evidence
of consent. In response, several commenters have urged the Commission
to require that prescribers maintain records pertaining to patients'
affirmative consent.\208\ According to some of these commenters, a
record of consent would allow more effective compliance monitoring,
while the burden of storing such a record would be minimal.\209\ By
contrast, the AOA states that prescribers should not be required to
maintain records of consent because the AOA believes it would be
burdensome \210\ and ``provides no obvious benefit to the patient''
since ``the likelihood of harm from a patient receiving a contact lens
prescription electronically is low to nonexistent.'' \211\ However,
other commenters countered that there is a potential for harm since
patients who do not consent might not realize that they received their
prescription electronically, or might be unable to access it.\212\
--------------------------------------------------------------------------- \208\ Consumer Action (SNPRM Comment #101); Information
Technology & Innovation Foundation (SNPRM Comment #103); National
Association of Optometrists and Opticians (SNPRM Comment #129);
Consumer Reports (SNPRM Comment #133); 1-800 CONTACTS (SNPRM Comment
#135). \209\ Consumer Action (SNPRM Comment #101) (stating that the
cost of storing digital records is not burdensome); Information
Technology & Innovation Foundation (SNPRM Comment #103) (stating
that the cost of storing a consent form would be virtually zero). \210\ See also American Society of Cataract and Refractive
Surgery (SNPRM Comment #127) (discussing the administrative burden
related to maintaining records of consent). Other commenters contend
that the burden of storing these records would be minimal.
Information Technology & Innovation Foundation (SNPRM Comment #103). \211\ American Optometric Association (SNPRM Comment #96). The
AOA also asserts that ``[p]atients do not have to consent to the
electronic delivery of other prescriptions.'' However, there may be
differences between contact lens prescriptions and some other types
of medical prescriptions. In many instances, other types of
prescriptions being delivered electronically are not being sent to a
patient, but rather to a pharmacy that then fills the prescription.
When a prescription is sent to a pharmacy, the patient would likely
have selected or have knowledge of the receiving pharmacy. In 2013,
57% of prescriptions nationally were sent electronically from
physicians to pharmacies, with the rate in some states over 80%.
U.S. Dep't of Health & Human Servs., The Office of the National
Coordinator for Health Information Technology, ``E-Prescribing
Trends in the United States'' 8 (2014) (stating also that 96% of all
community pharmacies in the U.S. accept e-prescriptions). \212\ R Street (SNPRM Comment #15); Coalition for Contact Lens
Consumer Choice (SNPRM Comment #89); Consumer Action (SNPRM Comment
#101); National Hispanic Medical Association (SNPRM Comment #146);
National Taxpayers Union (SNPRM Comment #149).
--------------------------------------------------------------------------- The Commission finds persuasive the arguments in favor of requiring
a record of patient consent to electronic delivery. The burden of
retaining a record of patient consent should be minimal, since
prescribers who opt for electronic delivery of prescriptions will, in
all likelihood, obtain and/or store such consent electronically. Even
if they do not, it should not take any longer to obtain and store
patient consent to electronic delivery than it would to obtain and
store a patient's Confirmation of Prescription Release via options (A),
(B) or (C). Furthermore, a prescriber is not required to offer patients
a digital prescription. Rather, it is at his or her option. Moreover,
consent to receipt of a digital copy would aid in enforcing the Rule
since,
[[Page 50684]]
without a record of consent, there would be no way for the Commission
to confirm that patients who were given their prescriptions
electronically agreed to such electronic delivery, and had the ability
to access their prescriptions in this manner. The Final Rule will thus
require that prescribers keep records or evidence of a patient's
affirmative consent to a digital copy for at least three years.
Although some commenters have sought longer retention periods,\213\
three years is a time period consistent with other recordkeeping
obligations in the Rule.
--------------------------------------------------------------------------- \213\ Information Technology & Innovation Foundation (SNPRM
Comment #103) (requesting five years); 1-800 CONTACTS (SNPRM Comment
#135) (requesting that the record be kept as long as the affirmative
consent is active). State laws could require that prescribers
maintain these records for longer than three years.
---------------------------------------------------------------------------
6. Comments About Alternatives to the Confirmation of Prescription
Release In addition to the suggestions--discussed previously--that the
Commission increase its enforcement of the current Rule, or impose new
requirements only as a penalty for specific providers found in non-
compliance,\214\ some commenters proposed alternative means of ensuring
that consumers receive their prescriptions.
--------------------------------------------------------------------------- \214\ American Optometric Association (SNPRM Comment #96).
---------------------------------------------------------------------------
a. Signage Several commenters reiterated the idea--raised and discussed in
some detail in the SNPRM \215\--that instead of requiring a patient
acknowledgment or confirmation, the Commission ought simply to require
that prescribers post signs informing consumers of their right to their
prescriptions.\216\ In its SNPRM, the Commission acknowledged that
signage offers some of the benefits of a patient confirmation, but
concluded that it had significant drawbacks: In the particular
environment of a prescriber's office, far fewer consumers would learn
of their rights from a sign than from being asked to sign a receipt;
signage would serve as less of a reminder to prescribers and their
staff to release prescriptions; signage would do nothing to aid the
Commission in monitoring and enforcing the prescription-release
requirement; and relying on patients to notice a sign and ask for their
prescriptions put the onus on consumers to enforce the Rule, and would
effectively amend the FCLCA's automatic-release provision to release-
upon-request, a statutory revision only Congress can make.\217\ The
Commission also noted that relying on consumers to ask for their
prescriptions is problematic since consumers might not see the sign, or
might be uncomfortable asking their prescribers for their
prescriptions.\218\ Based on those reasons, the Commission declined to
propose signage as an alternative to a Confirmation of Prescription
Release.\219\
--------------------------------------------------------------------------- \215\ SNPRM, 84 FR at 24679. \216\ Letter from 20 U.S. Senators (SNPRM Comment #38); Letter
from Sen. Lisa Murkowski (SNPRM Comment #49); Cutter (SNPRM Comment
#81); American Optometric Association (SNPRM Comment #96); Gilbert
(SNPRM Comment #119); Patel (SNPRM Comment #123); Letter from N.D.
State Sen. Judy Lee (SNPRM Comment #161). \217\ SNPRM, 84 FR at 24682-83. \218\ Id. at 24682. \219\ Id. at 24682-83.
--------------------------------------------------------------------------- Some SNPRM commenters agreed with the Commission's position,
stating that ``requiring prescribers to post signs doesn't work,''
\220\ and asserting that in California, where a state law requires
contact lens prescribers to post signs detailing patient rights, some
optometrists fail to comply, or post the signs in locations consumers
are unlikely to see them.\221\ In contrast, other commenters contended
that the Commission should reconsider the signage alternative,
reiterating that it would be less burdensome and intrusive for
prescribers and could address the FTC's educational objectives without
costly regulation.\222\ The AOA also took issue with the fact that the
Commission cited HHS's implementation of a signed-acknowledgment for a
prescriber's HIPAA obligation instead of opting for signage.\223\
According to the AOA, anything HHS concluded when it constructed the
HIPAA signed-acknowledgment is no longer relevant since HHS is now
considering eliminating the requirement and switching to signage in
order to reduce the burden on health care practitioners.\224\
Furthermore, according to the AOA, ``the physician community is united
in its belief'' that the HIPAA signed-acknowledgment should be
eliminated, and this shows that such acknowledgment requirements
constitute poor policy, and signage is a better option.\225\
--------------------------------------------------------------------------- \220\ Coalition for Contact Lens Consumer Choice (SNPRM Comment
#89); Consumer Action (SNPRM Comment #101). \221\ Americans for Tax Reform (SNPRM Comment #72). As noted in
the SNPRM, the Commission does not have empirical data about
prescriber compliance with the state signage requirement, 16 CCR
1566, which has been in effect in California since 1994. However, an
analysis of consumer survey evidence provided by Survey Sampling
International indicates that regardless of signage, Californians do
not automatically receive their prescriptions in substantially
greater numbers than residents of states without a signage
requirement. SNPRM, 84 FR at 24679. \222\ Kochik (SNPRM Comment #8) (stating that the real issue is
that patients are unaware of the law, and so the solution is
signage); Letter from 20 U.S. Senators (SNPRM Comment #38); Letter
from Sen. Lisa Murkowski (SNPRM Comment #49). \223\ American Optometric Association (SNPRM Comment #96). The
obligation in question is the HIPAA requirement that health care
providers provide patients with a Notice of Privacy Practices
(``NPP'') and obtain a patient's signature acknowledging receipt of
same. Notice of Privacy Practices for Protected Health Information,
14 CFR 164.520(c)(2)(ii). \224\ American Optometric Association (SNPRM Comment #96)
(quoting Request for Information on Modifying HIPAA Rules to Improve
Coordinated Care, 83 FR 64302, 64302-03 (2018), https://www.govinfo.gov/content/pkg/FR-2018-12-14/pdf/2018-27162.pdf#page=1.) \225\ American Optometric Association (SNPRM Comment #96). It is
worth noting that a review of the comments submitted in response to
the recent HHS proposal to eliminate HIPAA's signed-acknowledgment
requirement reveals that while many health care providers do
consider it an unnecessary use of staff time and resources, other
health care providers support the acknowledgment requirement, and
several noted that the burden of obtaining a patient's signed
acknowledgment is relatively minimal. See, e.g., Jackson Health
System (Comment in Response to Request For Information, Office for
Civil Rights, Department of Health and Human Services [hereinafter
``HHS RFI Comment''] #467) (does not support modifying the
requirement because signed NPP acknowledgment forms are ``useful''
to prove that the NPP was provided to the patient); Dr. Mitchell
Strauss (HHS RFI Comment #851) (``The signature is the only way of
confirming for posterity that the NPP was discussed. If this step is
no longer required, it will be far too easy for practices to stop
making the effort for acknowledgement of the NPP.''); Multnomah and
Clackmas Counties (HHS RFI Comment #926) (foresees adverse
consequences--potential complaints and misunderstandings--if signed
acknowledgment requirement is removed); San Francisco Department of
Public Health (HHS RFI Comment #1241) (``Having a written record
assures patients and covered entities that patients are informed
about privacy practices.''); American College of Osteopathic Family
Physicians (HHS RFI Comment #1262) (strongly believes that there
must be some level of accountability and responsibility for ensuring
patients understand their privacy rights); Massachusetts Department
of Mental Health (HHS RFI Comment #1003) (``The burden is
negligible.''); Missouri Hospital Association (HHS RFI Comment
#1175) (``MHA's members do not find the requirement cumbersome.'');
Cigna (HHS RFI Comment #1132) (``Obtaining acknowledgment of receipt
is not an operational burden [and] the burden to maintain document
of acknowledgment or declination is minimal.''). HHS RFI Comments
are available at https://www.regulations.gov/docketBrowser?rpp=25&po=0&D=HHS-OCR-2018-0028.
--------------------------------------------------------------------------- While it is true that HHS is presently evaluating whether to
eliminate the HIPAA Notice of Privacy Practices signed-acknowledgment
requirement, the Commission's Confirmation of Prescription Release
proposal, and the decision not to allow signage as an alternative, does
not rely on the HIPAA signed-acknowledgment requirement as precedent.
In the SNPRM, the Commission merely referenced aspects of HIPAA's
signed-acknowledgment requirement and HHS's evaluation of the
regulatory burden as informative when considering whether to require
some form of patient confirmation of
[[Page 50685]]
prescription release.\226\ Any other reliance on the HIPAA signed-
acknowledgment requirement is generally inappropriate since that
signed-acknowledgment requirement differs from the Commission's
confirmation proposal in important respects. The primary intent of the
HIPAA signed-acknowledgment was to provide patients an opportunity to
review the provider's Notice of Privacy Practices, discuss concerns
related to their private health information, and request additional
confidentiality.\227\ It was not to remedy a lack of compliance by
doctors with HIPAA requirements. Unlike this Rule review, the HHS
record does not contain empirical evidence showing that doctors are not
fulfilling their obligations to provide Notices of Privacy Practices to
patients, and only a handful of commenters to HHS's recent Request for
Information even suggested that this could occur should the HIPAA
signed acknowledgment be removed.\228\ This contrasts sharply with the
circumstances of the Commission's proposed Confirmation of Prescription
Release, which is intended to remedy a documented compliance gap
resulting, at least to some extent, from inherent incentives that may
discourage prescribers from providing patients with their
prescriptions.
--------------------------------------------------------------------------- \226\ SNPRM, 84 FR at 24682. \227\ Request for Information on Modifying HIPAA Rules to
Improve Coordinated Care, Office for Civil Rights, Department of
Health and Human Services, 83 FR at 64308. \228\ See generally Comments in Response to Request for
Information on Modifying HIPAA Rules to Improve Coordinated Care,
Office for Civil Rights, Department of Health and Human Services,
https://www.regulations.gov/docketBrowser?rpp=25&po=0&D=HHS-OCR-2018-0028.
--------------------------------------------------------------------------- The Commission continues to believe that for purposes of automatic
prescription release, signage would be significantly less effective
than the proposed Confirmation of Prescription Release. None of the
comments to the SNPRM presented any data or evidence that would counter
the Commission's prior conclusion. The AOA's argument that the HIPAA
signed-acknowledgment experience should not be looked to as a model
does not alter the Commission's determination that there is a
compelling need for a verifiable method of ensuring that contact lens
patients receive their prescriptions.
b. Educational Programs as an Alternative to Confirmation of
Prescription Release Some commenters opined that instead of having consumers confirm
that they received their prescription, the best manner to inform
consumers about their prescription rights was through an educational
program.\229\ According to one contact lens manufacturer, the FTC and
sellers should continue to ``communicate to patients through social
media, websites, advertising, and other channels so that patients
become even more aware that they can leave their final fitting with a
copy of their right prescription.'' \230\ Others suggested that the
Commission could partner with the Centers for Disease Control and the
Food and Drug Administration (``FDA'') to produce public service
announcements informing patients of their rights.\231\ Another
commenter suggested that instead of a signed confirmation, patients'
rights to their prescriptions could be ``spelled out in the entry forms
a patient signs when they check in.'' \232\ Similarly, the AOA
suggested that a ``patient bill of rights for contact lens wearers''
could be provided to patients that would include FDA information on
considerations for buying lenses.\233\ One commenter, the NAOO, said
that even with a Confirmation of Prescription Release, the Commission
should focus on educating the public about its rights to automatic
release of a prescription.\234\
--------------------------------------------------------------------------- \229\ Abert (SNPRM Comment #20); Tran (SNPRM Comment #94);
CooperVision, Inc. (SNPRM Comment #130). \230\ CooperVision, Inc. (SNPRM Comment #130). \231\ American Optometric Association (SNPRM Comment #96); Tran
(SNPRM Comment #94). \232\ Cutter (SNPRM Comment #81). \233\ American Optometric Association (SNPRM Comment #96). \234\ National Association of Optometrists and Opticians (SNPRM
Comment #129).
--------------------------------------------------------------------------- The Commission agrees that educating the public can aid in
increasing the likelihood that contact lens users will receive their
prescriptions after a fitting.\235\ Consumer education in itself,
however, whether provided via information entry forms, a patients' bill
of rights, advertising, or public service announcements, would not have
a significant impact on prescriber compliance with automatic
prescription release, and would not increase the Commission's ability
to monitor and enforce the Rule. The proposed education alternatives
would also place a burden on consumers to enforce their own rights, an
approach the Commission has rejected repeatedly in the past when
considering whether to amend the Contact Lens Rule and Eyeglass Rule to
release-upon-request.\236\ Therefore, while the Commission believes
education about the Rule and its automatic-prescription-release
provision is important, the Commission does not believe education
should be the sole means of improving Rule compliance.
--------------------------------------------------------------------------- \235\ The Commission educates consumers on their rights under
the Contact Lens Rule through a variety of sources, including blog
posts, Facebook, Twitter, and on the FTC's website. See, e.g.,
https://www.consumer.ftc.gov/articles/0116-prescription-glasses-and-contact-lenses. \236\ See Eyeglass I, 43 FR at 23998 (stating that relying upon
release-upon-request is problematic because many consumers are
unaware of their right to a prescription, and because the right
should be ``immunized from an evidentiary squabble over whether the
consumer actually did or did not request the prescription''); Final
Trade Regulation Rule, Ophthalmic Practice Rules 54 FR 10285, 10286-
87 (Mar. 13, 1989) [hereinafter Eyeglass II] (rejecting a proposal
to change the Rule to release-upon-request and finding a
``continuing need'' for automatic release). See also Contact Lens
Rule, 69 FR at 40492 (discussing a commenter proposal to allow
prescribers to not release the prescription or release it for
``informational purposes only'' if the patient has purchased a full
year's supply of contact lenses at the time of the examination, and
rejecting it because ``such an exception would be contrary to the
Act's express requirement that consumers receive a copy of their
prescription at the completion of a contact lens fitting'').
---------------------------------------------------------------------------
7. Comments About the Burden and Benefits of the Confirmation of
Prescription Release Proposal Many commenters stated that even with the proposed modifications to
increase flexibility, the Confirmation of Prescription Release
requirement is still overly burdensome for prescribers.\237\ According
to commenters, eye care practitioners are already overburdened by
regulatory requirements, and the confirmation requirement would divert
resources from patient care, increase health care costs, and might even
drive some prescribers to cease prescribing contact lenses or close
their practices.\238\ More specifically, the AAO stated that many of
the options for obtaining patient confirmation would require practices
to change procedures and alter administrative forms.\239\ Others noted
[[Page 50686]]
that the requirement to dispense paper copies of the confirmation to
patients runs counter to the trend towards electronic records,
particularly for those who have already invested in an electronic
recordkeeping system.\240\ One commenter opined that patients ought to
bear more responsibility for their own health care.\241\ Others noted
that the proposal was ``going against the tide'' by adding a new
regulation at a time when some government agencies are looking to
reduce regulations.\242\
--------------------------------------------------------------------------- \237\ Warner (SNPRM Comment #9); Mass Mail Campaign (SNPRM
Comment #25) (saying the requirement imposed ``massive new costs and
far-reaching new requirements on all contact lens prescribing'');
Yokum (SNPRM Comment #53); Staup (SNPRM Comment #104); American
Society of Cataract and Refractive Surgery (SNPRM Comment #127);
Letter from Sen. Lisa Murkowski (SNPRM Comment #49). \238\ Goldstein (SNPRM Comment #14) (``The economic burdens of
administrative compliance with these new regulations would except in
rare cases encourage me not to fit or prescribe contact lenses.'');
Pierce (SNPRM Comment #17) (will ultimately lead to higher health
care costs, might have to raise fees); Mass Mail Campaign (SNPRM
Comment #25); Shum (SNPRM Comment #80) (``Adding more paperwork and
scanning work--and making it required on everyone--doesn't sound
like it would be a big deal, but to a small practice it's huge.'');
Cinalli (SNPRM Comment #93) (new regulation will close many
practices); Klepfisz (SNPRM Comment #140) (burden has the potential
to put some prescribers out of business). \239\ American Academy of Ophthalmology (SNPRM Comment #136). \240\ Lowe (SNPRM Comment #40); Reeder (SNPRM Comment #55)
(signature upon receipt of prescription is ``burdensome and counter
to other initiatives to reduce paper held by offices''); Boyer
(SNPRM Comment #59) (``We try very hard to reduce paper waste . . .
. [This] will undo our efficiency and distract our staff from our
daily caseload, resulting in increased costs and reduced care.''). \241\ Steiner (SNPRM Comment #7). \242\ American Optometric Association (SNPRM Comment #96);
American Society of Cataract and Refractive Surgery (SNPRM Comment
#127).
--------------------------------------------------------------------------- Some commenters believed the Commission was underestimating the
burden to obtain confirmations and preserve the records, and provided
their own estimates, including that it would cost $10,000 per
year,\243\ or would require 10 minutes per patient for a total of ``850
man-hours per year,'' \244\ the equivalent of about 21 additional weeks
of work. The AOA, which had previously estimated the cost of the
signed-acknowledgment requirement to be as high as $18,795 per
optometrist,\245\ did not submit a new burden estimate for the
Confirmation of Prescription Release proposal, but reiterated its
belief that the Rule's burden falls disproportionately on prescribers,
and expressed concern that the estimated financial burden for the Rule
in the 2019 SNPRM is higher than the financial burden estimate cited
for the NPRM's signed-acknowledgment proposal.\246\ Some commenters
also stated that the use of option (D), electronic delivery, would not
significantly reduce their burden, since it would require them to
update their systems or invest in expensive technology.\247\ According
to the AOA, many prescribers would not be able to opt for electronic
delivery because of limitations in electronic health records systems,
privacy and data-security concerns, and state regulations that might
not permit prescription posting to portals.\248\
--------------------------------------------------------------------------- \243\ Pierce (SNPRM Comment #17). \244\ Steinemann (SNPRM Comment #65). \245\ American Optometric Association (NPRM Comment #3830). This
estimate was cited again by some commenters to the SNPRM. Koerber
(SNPRM Comment #41); American Society of Cataract and Refractive
Surgery (SNPRM Comment #127). In the SNPRM, the Commission explained
that it could not accord this estimate significant weight because it
was based not on the cost of the Commission's proposed Signed
Acknowledgment but on the overall cost of government regulations
(including those already in place), and because the survey had
various methodological limitations. SNPRM, 84 FR at 24677. \246\ American Optometric Association (SNPRM Comment #96). \247\ American Society of Cataract and Refractive Surgery (SNPRM
Comment #127). \248\ American Optometric Association (SNPRM Comment #96).
--------------------------------------------------------------------------- Other commenters disputed that the burden would be significant, and
stated that the confirmation requirement would not add significant
costs or time.\249\ According to the Information Technology &
Innovation Foundation, prescriber claims that the proposal would
require significant additional staff training are overstated.\250\
Another commenter, a prescriber, stated, ``In our office, we already
have patients sign a contact lens agreement before the contact lens
evaluation process. I don't see a problem adding a document at the end
of the process and having the patient sign an acknowledgment of rx
receipt.'' \251\ One commenter contended that while there would be some
burden on eye care providers, it represented just a ``tiny fraction''
of the industry's overall revenue, and would be far outweighed by the
benefits.\252\ Others asserted that allowing prescribers to provide
patients with digital copies would save both prescribers and patients
time and money.\253\ Some commenters suggested that the Commission was
actually over-estimating the burden imposed by the confirmation
requirement.\254\ 1-800 CONTACTS, for example, submitted a new analysis
from Stanford University Professor Laurence Baker, which called the
assumptions used in the Commission's burden analysis very
``conservative,'' and estimated that a reduction in verifications by
just 15% would be sufficient to offset all of the costs of the
confirmation requirement.\255\ The NAOO also felt the burden would be
``minimal,'' and opined that with more patients in possession of their
prescriptions, there would be fewer orders relying on the verification
process, and thus fewer verifications for prescribers to have to take
the time to respond to.\256\ NAOO also opined that with more
practitioners moving to practice management systems and electronic
health records, digital delivery of contact lens prescriptions is a
``very feasible'' option for many prescribers, which would reduce the
burden of the confirmation requirement.\257\
--------------------------------------------------------------------------- \249\ Tobias (SNPRM Comment #45); Rawson (SNPRM Comment #68);
(Citizen Outreach (SNPRM Comment #78); Consumer Action (SNPRM
Comment #101); Information Technology and Innovation Foundation
(SNPRM Comment #103); National Association of Optometrists and
Opticians (SNPRM Comment #129); Consumer Reports (SNPRM Comment
#133). \250\ Information Technology and Innovation Foundation (SNPRM
Comment #103) (``A few minutes of instruction, coupled with reading
a one- or two-page memo should more than suffice.''). \251\ Gilberg (SNPRM Comment #46). \252\ Taxpayer Protection Alliance (SNPRM Comment #118) (overall
burden of the new requirement would be minimal and outweighed by the
substantial benefit of having significantly more patients in
possession of their prescription). \253\ Grimm (SNPRM Comment #36) (proposal to allow new methods
for providing prescriptions will help relieve paperwork burden);
Coalition for Contact Lens Consumer Choice (SNPRM Comment #78); Liao
(SNPRM Comment #2) (portal proposal will make automatic release more
efficient). \254\ National Taxpayers Union (SNPRM Comment #149); 1-800
CONTACTS (SNPRM Comment #135, Ex. A). \255\ 1-800 CONTACTS (SNPRM Comment #135). \256\ National Association of Optometrists and Opticians (SNPRM
Comment #129). \257\ Id.
--------------------------------------------------------------------------- Some commenters also felt that the Commission should not give much
weight to burden concerns raised by prescribers due to their history of
not complying with their prescription-release obligations.\258\ The
National Hispanic Medical Association, for example, stated that the
focus on the burden for prescribers was ``upsetting when one remembers
just how many patients are being robbed of their right to lower prices
and more convenient shipping and being denied a copy of something that
they worked hard to pay for, namely, their own prescription.'' \259\
--------------------------------------------------------------------------- \258\ Information Technology & Innovation Foundation (SNPRM
Comment #103); 1-800 CONTACTS (SNPRM Comment #135); National
Hispanic Medical Association (SNPRM Comment #146). \259\ National Hispanic Medical Association (SNPRM Comment
#146).
--------------------------------------------------------------------------- The Commission has considered the burden the Confirmation of
Prescription Release requirement would place on prescribers. As stated
in the SNPRM, the evidentiary record does not establish that the burden
will be substantial.\260\ Nothing received or revealed since the SNPRM
alters that assessment. In fact, numerous health care providers--
commenting on their experience with HIPAA--said that the burden of
requiring that a patient sign a confirmation-type receipt is
``minimal,'' \261\ ``negligible,'' \262\ or ``not significant.'' \263\
And while AOA is
[[Page 50687]]
correct that the SNPRM's estimated financial burden for the
Confirmation of Prescription Release was higher than that estimated for
the Signed Acknowledgment, that was primarily due to an increase in the
average hourly wages for prescribers and staff.\264\ In terms of time
required for prescribers and their staff to comply, the SNPRM burden
from the confirmation proposal was 13% less than that of the NPRM's
signed-acknowledgment proposal.\265\ The estimated burden of this
modified Final Rule is also higher than the Signed Acknowledgment
proposal, but a large part of the increase is due to higher wages and a
substantial rise in the number of estimated contact lens wearers since
publication of the NPRM.\266\ Furthermore, while the Final Rule's
estimated financial burden for the Confirmation of Prescription Release
requirement of $20,428,750, is not insignificant, it amounts to
approximately just $342 in increased administrative costs per eye care
provider.\267\ In addition, while not every prescriber will be able to
use option (D) to deliver a prescription electronically, the Commission
is confident that this option will still reduce the burden for many,
especially as more prescribers move toward electronic recordkeeping.
--------------------------------------------------------------------------- \260\ SNPRM, 84 FR at 24681. \261\ Multnomah and Clackamas Counties (HHS RFI Comment #926);
Cigna (HHS RFI Comment #1132). \262\ Massachusetts Department of Mental Health (HHS RFI Comment
#1003). \263\ San Francisco Department of Public Health (HHS RFI Comment
#1238). See also Jackson Health System (HHS RFI Comment #467) (``The
acknowledgment procedure takes less than one minute.''); UnityPoint
Health (HHS RFI Comment #1122) (costs are relatively low, average of
60 seconds to explain NPP and obtain patient's signature); UC Health
(HHS RFI Comment #1155) (time spent to explain and obtain each
signed acknowledgment is 40 seconds per patient); Missouri Hospital
Association (HHS RFI Comment #1175); American Alliance of
Orthopaedic Executives (HHS RFI Comment #1183). Other commenters to
the HHS proposal disagreed, stating that the NPP signed
acknowledgment requirement was an unnecessary burden, although much
of their criticism was directed at the NPP itself rather than the
acknowledgment. See, e.g., American Physical Therapy Association
(HHS RFI Comment #601) (``Providers currently undertake reasonable
efforts to obtain the patient's signature, and in most instances the
patients ignore the language when signing the document.''); Highmark
Health (HHS RFI Comment #1124) (``The effort to comply with this
requirement is disproportionately onerous vis-[agrave]-vis the
general lack of attention individuals afford the NPP.''). \264\ SNPRM, 84 FR at 24693-94. \265\ SNPRM, 84 FR at 24693-94. \266\ See Section XI, infra. \267\ This is based on an estimate from Wallace Lovejoy, a
consultant for the National Association of Optometrists and
Opticians, that there are approximately 43,000 optometrists and
16,700 ophthalmologists in the U.S. CLR Panel I Tr., supra note 100,
at 6. Estimates vary as to the total number of eye care providers
and contact lens prescribers in the United States, making it
difficult to precisely calculate the burden on a per-provider or
per-prescriber basis. The investment firm Harris Williams & Co., for
instance, put the estimate at 46,000 optometrists and 18,000
ophthalmologists. Harris Williams & Co., Vision Industry Update, at
2 (Mar. 2017) https://www.harriswilliams.com/system/files/industry_update/vision_industry_update_hcls_0.pdf. Meanwhile, the
U.S. Bureau of Labor Statistics estimates there are 42,100
optometrists in the U.S., but does not provide an estimate for the
number of ophthalmologists. https://www.bls.gov/ooh/healthcare/optometrists.htm#tab-1. It must be noted, however, that not all
optometrists and ophthalmologists prescribe contact lenses.
---------------------------------------------------------------------------
8. Comments About the Exemption for Prescribers Who Do Not Have a
Direct or Indirect Financial Interest in the Sale of Contact Lenses In the SNPRM, the Commission proposed an exemption from the
Confirmation of Prescription Release requirement for prescribers who do
not have a direct or indirect financial interest in the sale of contact
lenses, including, but not limited to, though an association,
affiliation, or co-location with a contact lens seller.\268\ The
purpose of the proposed exemption was to reduce the burden on
prescribers who do not sell lenses, and therefore, have no incentive to
withhold prescriptions. The failure of the prescriber to provide the
prescription under such circumstances would provide no benefit to the
prescriber while likely alienating the patient. In fact, there is a
strong incentive to provide patients with their prescriptions, since
that is the only way they would be able to obtain contact lenses.
--------------------------------------------------------------------------- \268\ SNPRM, 84 FR at 24698.
--------------------------------------------------------------------------- At least one commenter voiced support for the exemption,\269\ but
some were critical of the proposal.\270\ Some commenters suggested
removing it in order to ``future proof'' the prescription-release
process in light of new and evolving business models--and intermingled
financial interests--between prescribers and contact lens sellers.\271\
According to one commenter, the exception for those without a financial
interest is ``intentionally vague and leaves the barn door open for
interpretation and abuse.'' \272\ The AOA also objected to the
underlying premise that prescribers might consider their own interests
above those of their patients.\273\
--------------------------------------------------------------------------- \269\ Consumer Reports (SNPRM Comment #133) (``Although getting
and keeping a record of the patient confirmation will not pose any
significant burden, by definition these prescribers would seem not
to pose any risk of conflict of interest in releasing the
prescription; indeed, they would have an inherent interest in
releasing it.''). \270\ Contact Lens Institute (SNPRM Comment #79); Zerbinopoulos
(SNPRM Comment #147); Johnson & Johnson Vision Care, Inc. (SNPRM
Comment #151). \271\ See Contact Lens Institute (SNPRM Comment #79); Johnson &
Johnson Vision Care, Inc. (SNPRM Comment #151); Alcon (SNPRM Comment
#117). \272\ Zerbinopoulos (SNPRM Comment #147). \273\ American Optometric Association (SNPRM Comment #96).
--------------------------------------------------------------------------- The Commission recognizes these concerns, but believes there is a
significant benefit in more narrowly targeting only those with an
incentive to withhold prescriptions, thereby further reducing the
overall burden and avoiding unnecessarily impacting prescribers who are
unlikely to violate the Rule. Moreover, the Commission believes that
determination of whether a financial interest exists is feasible, and
that prescribers are unlikely to arrange their financial interests and
business structures solely to circumvent the Confirmation of
Prescription Release requirement. The Commission also believes it has
the investigative tools to examine whether there is a financial
interest, should the need arise. And if the Commission determines upon
later review that such financial manipulation is occurring to
circumvent the Rule, the Commission can revisit whether to remove the
exemption.
D. Additional Discussion and Commission Determination Regarding the
Confirmation of Prescription Release Proposal The Commission has carefully reviewed and analyzed the entire
record developed with respect to the Confirmation of Prescription
Release proposal. This record includes more than 8,000 comments
submitted in response to its 2015 Request for Comment, 2016 NPRM, 2018
Contact Lens Workshop, and 2019 SNPRM, as well the original history and
legislative record relating to enactment of the FCLCA and the Rule in
2004. The evidentiary record as set forth in the NPRM and the SNPRM, as
well as the Commission's enforcement and oversight experience, supports
the view that compliance with the Rule's automatic-prescription-release
requirement is sub-optimal, and as a result, a substantial number of
consumers--several million contact lens users every year--are not
receiving their contact lens prescriptions as required by law. Many
consumers are unaware they even have a right to receive them.
Implementing a Confirmation of Prescription Release requirement will
result in an increase in the number of patients in possession of their
prescriptions; improved flexibility and choice for consumers; a reduced
verification burden for prescribers and sellers; a reduced likelihood
of medical errors associated with incorrect, invalid, and expired
prescriptions; and a reduction in the number of attempts to verify with
the wrong prescriber.\274\ The ultimate result will be improved
competition in the market, more efficient contact lens sales, improved
patient safety, and lower prices for consumers. Furthermore, the
[[Page 50688]]
requirement will increase the Commission's ability to enforce and
assess its Rule, and will accomplish this in a reasonable manner that
takes into consideration the needs and burdens of prescribers and
sellers.
--------------------------------------------------------------------------- \274\ SNPRM, 84 FR at 24681.
--------------------------------------------------------------------------- In response to commenters' concerns, the Commission has made three
modifications to the proposal put forth in the SNPRM. The Commission
concurs with the suggestion that requiring prescribers to identify the
specific method or methods they would use for electronic delivery of
prescriptions will increase awareness and allow patients to make a more
informed decision. The Commission will therefore define ``Provide to
the patient a copy'' in the Final Rule to require that prescribers who
choose to offer an electronic method of delivery identify the specific
method or methods used. The Commission also believes that evidence of
consumer consent to electronic delivery of a prescription will aid in
enforcing the Rule, and thus in its Final Rule, the Commission is
requiring that prescribers keep records or evidence of a patient's
affirmative consent to a digital copy for at least three years. Lastly,
for instances where a consumer refuses to sign the confirmation, in the
Final Rule, the Commission directs the prescriber to note the refusal
and preserve this record as evidence of compliance. The Commission
believes that the burden from these three changes will be minimal.
III. Additional Requirements for Sellers Using Verification Calls
Containing Automated Messages In response to the Commission's NPRM, a number of commenters
criticized the use of verification calls containing automated messages
(``automated telephone messages''), which they often refer to as
``robocalls,'' \275\ with some requesting an outright ban of these
calls.\276\ The Act and the Rule dictate that sellers that do not have
a contact lens prescription presented to them directly or by facsimile
verify the prescription by ``direct communication.'' \277\ That term,
in the Act and Rule, is defined as ``completed communication by
telephone, facsimile, or electronic mail.'' \278\ The Commission has
stated that the Act expressly permits telephone communication for
verification and believes that it would be contrary to congressional
intent to prohibit use of automated telephone calls for the purpose of
prescription verification.\279\
--------------------------------------------------------------------------- \275\ See SNPRM, 16 FR at 24684 and n.270. \276\ See SNPRM, 16 FR at 24685 and n.281. \277\ 15 U.S.C. 7603(a); 16 CFR 315.5(a)(2). \278\ Specifically, the Act defines direct communication to
``include'' a completed communication via one of these three
methods, 15 U.S.C. 7603(g), whereas the Rule defines ``direct
communication'' to ``mean'' a completed communication via one of
these three methods, 16 CFR 315.2, a distinction discussed below. \279\ SNPRM, 16 FR at 24684.
--------------------------------------------------------------------------- In response to the SNPRM, commenters continued to express criticism
of automated telephone messages \280\ with some continuing to urge the
Commission to ban them.\281\ The AOA indicated that issues surrounding
automated telephone messages have increased in the past five years and
that poor quality automated telephone messages are jeopardizing eye
health and resulting in consumers wearing non-prescribed contact
lenses. It reports an increase in the use of calls that are difficult
to understand, do not include all of the necessary information to
confirm the prescription, and create barriers for prescribers to
communicate corrections.\282\ Johnson & Johnson Vision Care and
individual prescribers believe that automated telephone messages can
ultimately lead to patients receiving incorrect lenses and suffering
adverse health outcomes.\283\
--------------------------------------------------------------------------- \280\ Gilberg (SNPRM Comment #46); Armitage (SNPRM Comment #66);
Contact Lens Institute (SNPRM Comment #79); American Optometric
Association (SNPRM Comment #96); Health Care Alliance for Patient
Safety (SNPRM Comment #128); CooperVision, Inc. (SNPRM Comment
#130); Johnson & Johnson Vision Care, Inc. (SNPRM Comment #151). \281\ Gilberg (SNPRM Comment #46); Armitage (SNPRM Comment #66);
Contact Lens Institute (SNPRM Comment #79); Health Care Alliance for
Patient Safety (SNPRM Comment #128); CooperVision, Inc. (SNPRM
Comment #130); Johnson & Johnson Vision Care, Inc. (SNPRM Comment
#151). \282\ American Optometric Association (SNPRM Comment #96). \283\ Reeder (SNPRM Comment #55) (automated calls and passive
verification can result in approval for patients who have never been
seen and can lead to injury); Armitage (SNPRM Comment #66) (no way
to safely and accurately ensure that a patient's prescription is
correctly verified with a robocall-based system); Johnson & Johnson
Vision Care, Inc. (SNPRM Comment #151). See also Alcon Vision, LLC
(SNPRM Comment #117) (noting health and safety risks associated with
robocalls).
--------------------------------------------------------------------------- Other commenters, however, indicated that automated telephone
messages were not problematic and should not be prohibited.\284\
Consumer Action stated that ``automated call systems appear to be
working in a majority of cases'' and that prescribers should design
more responsive systems for handling such requests.\285\ The NAOO
commented that from its members' perspective, there are ``no issues
with the use of automated calls, which tend to be infrequent to any
particular prescriber's office'' and that such calls are an efficient
method of verification.\286\
--------------------------------------------------------------------------- \284\ Consumer Action (SNPRM Comment #101); National Association
of Optometrists and Opticians (SNPRM Comment #129). \285\ Consumer Action (SNPRM Comment #101). \286\ National Association of Optometrists and Opticians (SNPRM
Comment #129); see also 1-800 CONTACTS (SNPRM Comment #135) (its
records indicate that ``on average, prescribers are asked to verify
just one order from 1-800 a week'').
---------------------------------------------------------------------------
A. The Congressional Record Does Not Support Prohibiting Automated
Telephone Messages Commenters in favor of a ban on such calls argue that the
Commission lacks evidence that Congress intended to include automated
calls in the definition of ``direct communication'' \287\ and should
eliminate the use of this antiquated technology in favor of methods
that provide written documentation and the possibility of greater
oversight in the verification process.\288\ In support of a ban,
commenters stated that the Act does not mention the use of automated
telephone messages and that the Commission's interpretation of such
calls as a valid form of ``direct communication'' may be counter to
testimony provided during hearings that occurred prior to the Act's
implementation.\289\ These commenters stated that ``congressional
members and the then CEO of a major online contact lens seller made
statements critical of automated telephone verification, stating
explicitly that fax or another verifiable method were the preferred
prescription verification methods for contact lens prescriptions.''
\290\
--------------------------------------------------------------------------- \287\ Health Care Alliance for Patient Safety (SNPRM Comment
#128); CooperVision, Inc. (SNPRM Comment #130); Johnson & Johnson
Vision Care, Inc. (SNPRM Comment #151). \288\ Health Care Alliance for Patient Safety (SNPRM Comment
#128); CooperVision, Inc. (SNPRM Comment #130); Johnson & Johnson
Vision Care, Inc. (SNPRM Comment #151). CLR Panel IV Tr., supra note
121, at 9 (request of Steinemann for written requests only and not
``robocalls''). \289\ Health Care Alliance for Patient Safety (SNPRM Comment
#128); Johnson & Johnson Vision Care, Inc. (SNPRM Comment #151). \290\ Health Care Alliance for Patient Safety (SNPRM Comment
#128); Johnson & Johnson Vision Care, Inc. (SNPRM Comment #151).
--------------------------------------------------------------------------- A closer analysis of the congressional testimony reveals a question
to the CEO of the contact lens seller about earlier testimony by the
AOA mentioning problems with both automated calls and continuous
faxes.\291\ The CEO's
[[Page 50689]]
response merely recognized that there had been criticism of automated
calls, and stated that at that time the company preferred fax
verifications because they were written.\292\ There is no other mention
of issues with automated calls by congressional members or the CEO
during that hearing.\293\ Instead, such testimony arguably shows that
Congress had been made aware of the criticisms of automated calls and,
if it had wished to do so, could have banned their use explicitly. Yet,
Congress specifically included telephone as a valid form of direct
communication. The hearing also evidences a recognition that telephone
communications, unlike faxes, would not be written. As a result,
reference to this testimony does not change the Commission's view that
automated telephone messages are a permissible form of direct
communication.
--------------------------------------------------------------------------- \291\ 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) (Rep. Shimkus: ``Mr. Coon [CEO of 1-800 CONTACTS],
there have been some questions [raised in earlier hearing testimony
from the AOA] about the techniques companies like yours use to
verify orders for contact lens prescriptions, and problems such as
automated calls and continuous faxes inhibiting optometrists from
verifying prescriptions. Could you just go through your procedures
for me?''). \292\ Id. (In response to Rep. Shimkus's request to go through
the company's procedures, Rep. Burr: Mr. Coon, how does 1-800
currently request doctor verification? Mr. Coon: Well, the best
system that we have found works the best, which we do in a majority
of our orders--and there has been criticism of phone automated
systems and other things. The system that works the best is in
writing by fax. We know that there is a confirmation that it was
received. And that's the system that we would recommend.''). \293\ The Commission is also unaware of any other on-the-record
discussions about automated calls during congressional consideration
of the FCLCA.
--------------------------------------------------------------------------- The Health Care Alliance for Patient Safety referred to automated
telephone messages as antiquated technology,\294\ and stated that the
Commission should ban such calls in favor of methods that provide
verifiable written communication, including fax, emails, and electronic
portals.\295\ Such documentation, according to the Alliance, will allow
for greater oversight and a safer environment allowing prescription
verification through clearer, more concise and accurate communication
between the prescriber and the seller.\296\ As previously stated,
Congress expressly permitted use of the telephone knowing that this
method did not produce writings like the other delineated verification
methods, facsimile and email, and thus, the Commission declines to
prohibit the use of this medium for verification.
--------------------------------------------------------------------------- \294\ Health Care Alliance for Patient Safety (SNPRM Comment
#128). \295\ Health Care Alliance for Patient Safety (SNPRM Comment
#128); CooperVision, Inc. (SNPRM Comment #130). The Commission
declines to include portals as a method by which sellers can verify
prescriptions. In considering the proposal, the Commission
considered that the Act defines direct communication to include
telephone, fax, or email. As stated in the 2004 SBP, Congress's use
of the term ``includes'' contemplates that additional methods of
communication could develop that could be used in the verification
process. 69 FR 40490. However, there is no evidence that prescribers
and sellers are using, or are likely to use, portals in the
verification process. \296\ Health Care Alliance for Patient Safety (SNPRM Comment
#128). The Contact Lens Institute criticized the Commission for
failing to address the fact that the information conveyed in a
telephonic communication needs to be reduced to a writing by the
prescriber's office so it can be compared to patient records, a
process that must in virtually all cases be conducted separately
from the call itself. SNPRM Comment #79. It follows, according to
CLI, that written requests are more efficient and effective
communication tools for both sellers and prescribers.
---------------------------------------------------------------------------
B. Comments About, and Adoption of, Requirements Proposed in the SNPRM
To Improve Quality of Automated Telephone Messages In the SNPRM, the Commission recognized that additional
requirements for automated verification calls were necessary to relieve
the burden on prescribers and reduce potential health risks to patients
from incomplete or incomprehensible automated telephone messages.
Specifically, the Commission noted that prescribers must be able to
understand automated messages so they can, if necessary, respond to
sellers to prevent improper sales.\297\ As a result, the Commission
proposed, via an amendment to Sec. 315.5, requirements for sellers to
improve verification calls that use, in whole or in part, an automated
message. For these calls, sellers must: (1) Record the entire call; (2)
commence the call by identifying it as a request for prescription
verification; (3) provide the information required by Sec. 315.5(b) in
a slow and deliberate manner and at a reasonably understandable volume;
and (4) give the prescriber the option to repeat the information.\298\
--------------------------------------------------------------------------- \297\ SNPRM, 16 FR at 24685. \298\ SNPRM, 16 FR at 24685.
--------------------------------------------------------------------------- Commenters were largely in favor of the Commission's proposals to:
(1) Commence the call by identifying it as a request for prescription
verification; (2) provide the information required by Sec. 315.5(b) in
a slow and deliberate manner and at a reasonably understandable volume;
\299\ and (3) give the prescriber the option to repeat this
information.\300\ Seller 1-800 CONTACTS indicated that its verification
messages already comply with these proposed requirements, and the NAOO
indicated that its members have not identified any significant burdens
in complying with these requirements.\301\ CooperVision indicated that
these proposals, along with some of the Commission's other proposals,
helped address some of the more troubling issues with automated
messages.\302\ On the other hand, the Contact Lens Institute, comprised
of the major contact lens manufacturers, indicated that the
Commission's proposed measures demonstrate the impossibility of
assuring that automated messages provide effective communication of
required information and a reliable basis for passive
verification.\303\ For instance, it stated that the Commission's
requirements to commence the call by identifying it as a request for
prescription verification and to give prescribers an option to repeat
assumes that prescribers will have live staff available 24 hours a day
and will not need to rely on recording devices.\304\
--------------------------------------------------------------------------- \299\ The Commission notes that these criteria have always been
part of the Rule, but it has determined that they should be
expressly set forth in the Rule. See 81 FR 88540 (``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.''). \300\ American Optometric Association (SNPRM Comment #96)
(stating support for these requirements, but expressing concern they
are coming too late); National Association of Optometrists &
Opticians (SNPRM Comment #129); 1-800 CONTACTS (SNPRM Comment #135);
Johnson & Johnson Vision Care, Inc. (SNPRM Comment #151) (expressing
approval for these provisions should the Commission not prohibit
these calls altogether). \301\ National Association of Optometrists & Opticians (SNPRM
Comment #129); 1-800 CONTACTS (SNPRM Comment #135). \302\ CooperVision, Inc. (SNPRM Comment #130). \303\ Contact Lens Institute (SNPRM Comment #79). Members of the
Contact Lens Institute are Alcon Vision, Bausch + Lomb, CooperVision
and Johnson & Johnson Vision Care. The Commission notes that the
opinions expressed in the CLI's comment do not always conform with
the opinions of the manufacturers as expressed in their individually
filed comments. \304\ It also described the Commission's requirement to deliver
the message in a ``slow and deliberate manner'' and at a
``reasonable volume'' as so vague as to be potentially
unenforceable. Contact Lens Institute (SNPRM Comment #79. The
Commission disagrees with this assessment, finding that these
conditions are met if, upon listening to a call, the required
information is comprehensible to a reasonable person.
--------------------------------------------------------------------------- The Commission does not find these criticisms compelling. The
Commission recommended these proposals with an awareness that sometimes
prescribers' offices take these calls live and, at other times, the
calls are left on recording devices. An option to repeat the
information is helpful if a person answers live. If not, the prescriber
has the ability to replay the message from the recording device.
Similarly, commencing the call by identifying it as a request for
prescription verification should help ensure that the prescriber's
office is ready to take the relevant information down, both when
answering live and when playing the message from a recording device. As
a
[[Page 50690]]
result, the Commission is implementing these amendments in its Final
Rule.
C. The Commission's Proposal Requiring Sellers To Record Automated
Telephone Messages In the SNPRM, the Commission also requested comments on its
proposed amendment to Sec. 315.5 to require sellers who verify
prescriptions through automated telephone verification messages to
record the entire call.\305\ Some commenters opposed the proposal,\306\
while others supported it.\307\ 1-800 CONTACTS opposed the recording
requirement, stating that it would impose a costly burden on sellers,
is unnecessary because the Commission lacks evidence of a systematic
problem with automated calls, and would not facilitate enforcement or
improve compliance.\308\ This seller also commented that the
requirement combined with state wiretapping laws may cause sellers to
switch to other, perhaps less-reliable verification methods.\309\ In
favor of the proposal, the AOA indicated that the cost of compliance is
justified given the widespread issues with robocalls that currently
exist.\310\
--------------------------------------------------------------------------- \305\ SNPRM, 84 FR at 24685. \306\ Contact Lens Institute (SNPRM Comment #79); 1-800 CONTACTS
(SNPRM Comment #135); Consumer Reports (Comment #133). \307\ The Health Care Alliance for Patient Safety (SNPRM Comment
#128), CooperVision, Inc. (SNPRM Comment #130), and Johnson &
Johnson Vision Care, Inc. (SNPRM Comment #151), supported the
recording requirement if the Commission did not ban automated
telephone messages altogether. See also American Optometric
Association (SNPRM Comment #96); National Association of
Optometrists & Opticians (SNPRM Comment #129). \308\ 1-800 CONTACTS (SNPRM Comment #135). \309\ Id. \310\ American Optometric Association (SNPRM Comment #96).
--------------------------------------------------------------------------- In support of its position that the recording requirement is
unnecessary, 1-800 CONTACTS pointed to the Commission's statement in
the SNPRM that it does not have empirical data showing the frequency of
verification calls that contain incomplete or incomprehensible
automated messages.\311\ The seller further commented that the number
of sellers that use this particular technology is likely limited and
the Commission can much more easily acquire the evidence necessary to
investigate complaints and bring an enforcement action in appropriate
circumstances.\312\ It stated that ``the same cost-benefit approach
that justifies additional recordkeeping for prescription release,
counsels against additional superfluous and costly regulation and in
favor of targeted enforcement.'' \313\ Consumer Reports noted that it
was not aware of noncompliance similar to that of prescribers' failure
to release prescriptions.\314\
--------------------------------------------------------------------------- \311\ 1-800 CONTACTS (SNPRM Comment #135). \312\ 1-800 CONTACTS stated that the Commission lacked evidence
about whether problems occur with automated calls of more than a
limited number of sellers, and if it is a limited number of sellers,
the Commission should consider education and enforcement efforts
instead of rule changes. For instance, the Commission could obtain
the recording itself from prescribers who assert that they have
received an invalid or incomprehensible verification call. Id.
Although the Commission could obtain such recordings from
prescribers, the information would not be complete. Without the
ability to obtain recordings from the seller, the Commission would
be unable to assess if the call the seller relied on was compliant,
was non-compliant (violating the Rule) but an anomaly, or was part
of a widespread use of problematic calls. Moreover, as to its point
about the limited number of sellers making these calls, new contact
lens sellers are routinely entering the market and the Commission
needs to ensure it can enforce against them if it receives
complaints. \313\ 1-800 CONTACTS (SNPRM Comment #135). \314\ Consumer Reports (SNPRM Comment #133).
--------------------------------------------------------------------------- The Commission lacks empirical data on this issue, as noted in the
SNPRM.\315\ However, it is undisputed that automated telephone messages
are a commonly used method of verification. Moreover, these calls
impose a cost on prescribers, and there are potential health risks to
patients from incomplete and incomprehensible automated telephone
requests.\316\ In fact, many commenters have indicated problems with
the quality of automated telephone messages.\317\ The AOA commented in
response to the SNPRM that, in its survey of 629 doctors of optometry,
85% reported that automated calls for prescription verifications have
increased in the past five years, and 88% indicated that the quality of
such calls has decreased in the past five years.\318\ These commenters
have exposed an issue for enforcement: Without a call recording,\319\
the Commission cannot reliably assess whether that call was compliant
and further whether the seller has a pattern of placing non-compliant
calls (and selling after such calls).
--------------------------------------------------------------------------- \315\ SNPRM, 84 FR at 24685. \316\ Id. \317\ NPRM, 81 FR at 88538 nn.152, 154, 155; SNPRM, 84 FR at
24684 n.270. See also CLR Panel IV Tr., supra note 121, at 8
(statement of David Cockrell that the office can't understand many
of the robocalls); id. at 8 (statement of Tim Steinemann that many
robocalls are unintelligible or cut off). \318\ American Optometric Association (SNPRM Comment #96).
However, because the AOA did not provide the survey itself or the
data from the survey, the Commission does not rely on it as more
than anecdotal evidence. \319\ The Commission has received numerous comments from
prescribers indicating that they have received non-compliant
messages, some of which were left on their answering machines, yet
has received very few actual recordings of these messages from
prescribers.
--------------------------------------------------------------------------- 1-800 CONTACTS commented that it is an unnecessary burden for
sellers to record and retain copies of thousands of identical
verification calls, the costs of which would exceed the benefits.\320\
Consumer Reports shared this sentiment and suggested that it would be
more reasonable for the Commission to require sellers to retain a
sample recording of the standard script, leaving blanks for
prescription and patient details.\321\ The Commission believes that
seeing a script of information relayed or a sample recording has
limited utility. A script or a sample recording would not reveal
whether the required information was transmitted for any particular
automated telephone message or if, for instance, required information
was transmitted before a representative or machine answered, after an
answering machine cut off, when a prescriber's office put the call on
hold, or over hold music, in which case the call could not be lawfully
used as a basis for the sale.\322\ Further, a script or sample
recording would not permit the Commission to assess whether each call
was delivered in a ``slow and deliberate manner'' and at a ``reasonably
understandable volume.'' Without knowing this information, the
Commission would be unable to determine conclusively whether any
particular verification request was valid. Therefore, the Commission is
not adopting this recommendation.
--------------------------------------------------------------------------- \320\ 1-800 CONTACTS (SNPRM Comment #135). \321\ Consumer Reports (SNPRM Comment #133). \322\ One commenter requested a requirement for online sellers
to maintain files of recordings of each verification attempt made by
automated message for a period of no less than three years. Health
Care Alliance for Patient Safety (SNPRM Comment #128). The
Commission is only requiring sellers to maintain recordings of
automated telephone calls that are the basis for the sale, and to
maintain these recordings for three years. There is no need under
the Rule for sellers to maintain recordings of unsuccessful
verification attempts.
--------------------------------------------------------------------------- 1-800 CONTACTS asserted that the requirement to record verification
calls would not only impose additional regulatory burdens on sellers,
but also expose sellers to legal risk.\323\ The seller argued that by
recording telephone communications, sellers might risk violating two-
party consent laws in the states that require all parties on the call
to consent to recordings.\324\ After
[[Page 50691]]
reviewing the relevant statutes and applicable case law, the Commission
does not believe sellers risk conducting illegal calls by recording
them.\325\
--------------------------------------------------------------------------- \323\ 1-800 CONTACTS (SNPRM Comment #135). \324\ Twelve states have such a requirement: California,
Connecticut, Delaware, Florida, Illinois, Maryland, Massachusetts,
Montana, Nevada, New Hampshire, Pennsylvania, and Washington. See
Cal. Penal Code Sec. 632(a), (c) (West 2019); Conn. Gen. Stat.
Sec. 52-570d(a) (West 2019); Del. Code Ann. tit. 11, Sec. 2402(a),
(c)(4) (West 2019); Fla. Stat. Ann. Sec. 934.03(1), (3)(d) (West
2019); 720 Ill. Comp. Stat. Ann. 5/14-2(a) (West 2019); Md. Code.
Ann., Cts. & Jud. Proc. Sec. 10-402(a), (c)(3) (West 2019); Mass.
Gen. Laws Ann. ch. 272, Sec. 99(C) (West 2019); Mont. Code Ann.
Sec. 45-8-213(1)(c), (2)(a)(iii) (West 2019); Nev. Rev. Stat. Ann.
Sec. 200.620 (West 2019); N.H. Rev. Stat. Ann. Sec. 570-A:2
(2019); 18 Pa. Stat. and Cons. Stat. Ann. Sec. 5703, 5704(4) (West
2019); Wash. Rev. Code Ann. Sec. 9.73.030(1), (3) (West 2019). It
is also possible that Michigan has a two-party consent law, although
interpretations of the law differ, and the issue has not been firmly
resolved. See Mich. Comp. Laws Ann. Sec. 750.539c (``Any person . .
. who willfully uses any device to eavesdrop . . . without the
consent of all parties thereto . . . is guilty of a felony). Compare
AFT Mich. v. Project Veritas, 378 F. Supp. 3d 614, 620 (E.D. Mich.
2019) (finding statute prohibits participants from recording private
discourse of any other person involved in the conversation unless
all persons consent); with Sullivan v. Gray, 324 N.W.2d 58, 60
(Mich. Ct. App. 1982) (finding statute does not require two-party
consent because it only prohibits eavesdropping, which is defined as
recording the ``private discourse of others.'' (emphasis added)). \325\ Of course, the Commission cannot predict precisely how
different jurisdictions will apply state laws. However, the
Commission is unaware of a party ever being held liable for
violating two-party consent requirements in a situation where the
call contained a disclosure message at its onset. The Commission
further notes that jurisdictions take different approaches to
deciding which state law applies for interstate or multi-state phone
calls. See, e.g., Ditech Fin. LLC v. Buckles, 401 P.3d 215 (Nev.
2017). Therefore, when recording calls with prescribers located in
other states, sellers should abide by the more stringent law that
applies or obtain the consent of all parties to the communication.
As the Commission stated in the SNPRM, 84 FR at 24685 n.288, sellers
are responsible for determining compliance with state law taping
requirements.
--------------------------------------------------------------------------- For instance, though the California penal code prohibits
eavesdropping on or recording confidential communications without two-
party consent, the code excludes from the definition of ``confidential
communication'' any circumstances ``in which the parties to the
communication may reasonably expect that the communication may be
overheard or recorded.'' \326\ The California Supreme Court has
stressed that Sec. 632 of the California penal code does not preclude
parties from ever recording conversations, but rather prohibits parties
from doing so ``secretly'' or ``surreptitiously,'' declaring that a
business would not violate the state's wiretapping laws if it advised
parties to a communication of its intent to record the call at the
outset of the conversation.\327\ Similarly, in Massachusetts, a person
cannot willfully intercept any wire or oral communication, with
``interception'' defined in the statute as secretly hearing, secretly
recording, or aiding another to do so without the parties'
consent.\328\ The Massachusetts Supreme Court has ruled that a system
that expressly notifies the parties that the call will be recorded does
not commit an interception because the system does not record the
conversation in secrecy.\329\ Thus, in California and Massachusetts,
sellers who provide a standard notification at the beginning of the
call, which has become customary in many business communications, are
unlikely to risk violating state wiretapping laws.
--------------------------------------------------------------------------- \326\ Cal. Penal Code Sec. 632(a), (c). \327\ Kearney v. Salomon Smith Barney, Inc., 137 P.3d 914, 930
(Cal. 2006); see also Hataishi v. First Am. Home Buyers Prot. Corp.,
168 Cal. Rptr. 3d 262, 271 (Cal. Ct. App. 2014) (stating California
consumers are accustomed to receiving notice of a business's
intention to record a call); CS Wang & Assoc. v. Wells Fargo Bank,
N.A., 305 F. Supp. 3d 864, 885 (N.D. Ill. 2018) (Under the
California Invasion of Privacy Act, ``the baseline assumption in
situations where the recorded party does not initiate the call, does
not have a prior relationship with the caller, and does not receive
a warning at the outset of the call, is that it is reasonable for a
party to expect that its conversation is not being recorded.'')
(emphasis added). \328\ See Mass. Gen. Laws Ann. ch. 272, Sec. 99(B)(4), (C)(1). \329\ See Commonwealth v. Boyarsky, 897 N.E.2d 574, 579 (Mass.
2008) (finding ``there was no interception because there was no
secret recording, and the inquiry is at an end''); see also Marquis
v. Google, Inc., No. SUCV2011-02808-BLS1, 2014 WL 4180400, at *12
(Mass. Super. Ct. July 27, 2014) (``The core of the statute is . . .
the prevention of the secret interception of wire communications . .
. . In consequence, if a recording is `not made secretly,' it does
`not constitute an `interception'' and there has been no violation
of the statute.'').
--------------------------------------------------------------------------- Moreover, after reviewing the plain language of other state
statutes requiring two-party consent and case law, the Commission
concludes that if sellers express their intentions to record the
conversation at the outset of each call, sellers located in or
contacting prescribers in two-party consent states will not risk
violating a state's respective wiretapping law. Announcements at the
outset of the calls would prevent sellers from committing violations
because prescribers can either provide or withhold consent. For
instance, under Florida's and Maryland's statutes,\330\ as long as a
party has received notice of an intent to record, the notified party
can expressly or impliedly consent by remaining on the line.\331\ 1-800
CONTACTS notes that a prescriber could effectively reject a valid
method of verification--verification by telephone--by declining to give
consent.\332\ In the event that a prescriber declines to consent to a
recorded call containing an automated telephone verification message,
sellers may make verification requests via email, live call, or fax.
Sellers may also elect to leave automated telephone messages after
hours on prescribers' answering machines. Such calls would not
implicate wiretapping laws since the prescriber is not on the
line.\333\
--------------------------------------------------------------------------- \330\ Fla. Stat. Ann. Sec. 934.03(2)(d); Md. Code. Ann., Cts. &
Jud. Proc. Sec. 10-402(a), (c)(3). \331\ See Levin v. Red Rock Fin. Servs., LLC, No. 70006, 2017 WL
519414, at *1 (Nev. Ct. App. Jan. 30, 2017) (agreeing that summary
judgment applying Nevada and Florida law had been properly granted
because appellant ``necessarily heard the pre-recorded announcement
during every phone call . . . and consequently gave implied consent
to be recorded during each call by continuing with the call'')
(emphasis added); Briddell v. State, No. 1220, 2016 WL 4698158, at
*3-4 (Md. Ct. Spec. App. Sept. 7, 2016) (finding plaintiff ``was not
forced to communicate . . . nor continue with the phone conversation
after being notified that it would be recorded and monitored'' and
consented to recording ``by continuing to speak after the [warning]
messaged [had] played.'') (emphasis added). See also Wash. Rev. Code
Ann. Sec. 9.73.030(3) (``[C]onsent shall be considered obtained
whenever one party has announced to all other parties engaged in the
communication or conversation, in any reasonably effective manner,
that such communication or conversation is about to be recorded or
transmitted.''). \332\ 1-800 CONTACTS (SNPRM Comment #135). \333\ Some prescribers commenting on the Rule have expressed
concern that verification calls placed during non-business hours
violate the Rule. See NPRM, 81 FR at 88544 and n.232. Sellers who
leave compliant verification messages after hours do not violate the
Rule as long as they wait the required eight business hours before
selling lenses (assuming there is no communication from the
prescriber invalidating or approving the message before that time
period concludes).
--------------------------------------------------------------------------- Commenters also opined on whether the Commission should extend its
recording requirement to verification calls that do not involve
automated messages, i.e., live calls. 1-800 CONTACTS suggested that the
requirement to record calls including automated messages should apply
equally to live calls because sellers might otherwise have an incentive
to outsource live verification calls to inexpensive call centers that
can ``game the system'' by making it difficult for prescribers to
understand or respond to live verification requests.\334\ On the other
hand, the NAOO, without explanation, supported the Commission's
recording requirement for automated calls as long as the Commission
does not expand the requirement to apply to live calls.\335\
--------------------------------------------------------------------------- \334\ 1-800 CONTACTS (SNPRM Comment #135). The seller also
pointed to the Commission's statement in the SNPRM that it does not
know that a phone call with an automated message is necessarily less
reliable than one with a live person. Id. (citing SNPRM, 84 FR at
24685). \335\ National Association of Optometrists and Opticians (SNPRM
Comment #129).
--------------------------------------------------------------------------- For several reasons, the Commission declines to compel sellers to
record live calls. Foremost, during live calls, a prescriber can ask a
seller to repeat the message or to clarify unintelligible information,
and can look up a patient's file in real time to verify the
[[Page 50692]]
prescription.\336\ In this setting, a seller is likely to limit any bad
conduct. While bad actors could speak incoherently, exclude key
information, or refuse to repeat the message when asked, the Commission
has not received or seen evidence of such behavior, and the record does
not reflect any other widespread issue involving the quality of live
calls. Finally, the Commission considered mass merchandisers that
verify prescriptions largely or exclusively by calling prescribers to
obtain verification via a live call when a customer purchases lenses at
the store. Because these sellers use their phone lines for a multitude
of purposes unrelated to prescription verification, such as taking
consumer orders or checking inventory for a consumer, it would be
difficult to implement a recording system in compliance with this Rule.
However, should the Commission receive complaints that show an issue
with sellers' conduct on live calls, the Commission will reassess the
need to require sellers to record live verification calls.
--------------------------------------------------------------------------- \336\ CLR Panel IV Tr., supra note 121, at 15 (statement of
David Cockrell referring to how live calls provide opportunity for
two-way conversation).
---------------------------------------------------------------------------
D. The Final Rule Does Not Adopt Commenters' Additional Recommendations
Regarding Automated Telephone Messages A number of additional recommendations were suggested by commenters
regarding calls that contain, in full or in part, automated
messages.\337\ The Health Care Alliance for Patient Safety and Johnson
& Johnson Vision Care requested that the FTC review and approve a
transcript of sellers' automated telephone messages before sellers are
permitted to use calls containing such messages.\338\ The Contact Lens
Institute urged the Commission to require sellers to follow a
``specific script that includes standardized terms, a standardized
order of presenting the required information, and a standardized
pace,'' \339\ and to require sellers to document that they only use
means of transmission that have been tested and shown to result in
receipt of clear and unambiguous information at the receiving end of
the call.\340\
--------------------------------------------------------------------------- \337\ The Contact Lens Institute (SNPRM Comment #79), Health
Care Alliance for Patient Safety (SNPRM Comment #128), and Johnson &
Johnson Vision Care, Inc. (SNPRM Comment #151) proposed these
additional requirements in the event that the Commission declined to
prohibit use of verification via automated telephone messages. \338\ Health Care Alliance for Patient Safety (SNPRM Comment
#128); Johnson & Johnson Vision Care, Inc. (SNPRM Comment #151). \339\ Contact Lens Institute (SNPRM Comment #79). Alcon Vision
made a similar recommendation. See SNPRM Comment #117. \340\ Contact Lens Institute (SNPRM Comment #79).
--------------------------------------------------------------------------- The Commission is not implementing these recommendations. The
information that sellers need to include to make a valid verification
request is clearly delineated in Sec. 315.5(b), (d)(2), and (d)(4) of
the Final Rule.\341\ The Commission does not believe that reviewing and
approving a transcript would be an effective use of its resources
because it is the call itself that ultimately determines whether there
is a valid verification request. Further, while there is some utility
in providing a script so prescribers receive the information in a
predictable manner, the Commission is not convinced that there is only
one effective way for a seller to comply with the Rule, or that this
requirement is necessary.\342\ The Rule already indicates what
information needs to be included in the message, and the additional
requirements the Commission is implementing should make it easier for
prescribers to obtain the information. Should seller verification
messages be deficient in providing all the required information,
prescribers should notify the seller. Moreover, assuming a seller is
complying with the Rule by recording calls that contain these messages,
the Commission can ascertain whether the call included all the required
information (and whether the seller ultimately sold lenses pursuant to
an invalid verification call). A review of the recording will provide
better information on compliance than would knowing that the seller
used a transcript--including an FTC-approved transcript--or a means of
transmission that the seller has tested and documented as effective.
--------------------------------------------------------------------------- \341\ Commission review of a script would not reveal whether the
seller was complying with Section 315.5(d)(3) and (4) of the Final
Rule (the requirements as to cadence, volume, and the ability to
repeat the information). \342\ Similarly, 1-800 CONTACTS requested a requirement that a
pre-recorded message be limited to providing only the information
required under the Rule and not include extraneous information that
could make the call confusing or more burdensome. SNPRM Comment
#135. Although the Commission cautions sellers against including
extraneous information, it has not seen evidence of a widespread use
of calls including such information and thus is not implementing
this recommendation.
--------------------------------------------------------------------------- The Health Care Alliance for Patient Safety and Johnson & Johnson
Vision Care also requested a requirement that online sellers confirm
that automated calls are answered by a person at the prescriber's
office, as opposed to a recording device, before initiating an
automated message.\343\ In essence, they are asking for a requirement
that all verification calls be placed during a prescriber's business
hours, presumably the time when prescribers' phone lines are
staffed.\344\ These commenters also requested that the Commission
require online sellers who use automated telephone messages to provide,
for prescriber's use, a centralized call-back number and have the call-
back number staffed by a person from the seller.\345\ In the same vein,
CooperVision commented that the Commission should require sellers to
provide the means for the prescriber to disrupt a verification call
that uses, in whole or in part, an automated message, in order to
connect with a person at the seller to provide correct
information.\346\ Without this requirement, according to CooperVision,
eye care professionals are limited in their ability to correct
information that is important for the patient's eye health or that
could prevent improper substitution of lenses.\347\
--------------------------------------------------------------------------- \343\ Health Care Alliance for Patient Safety (SNPRM Comment
#128); Johnson & Johnson Vision Care, Inc. (SNPRM Comment #151). \344\ It is not clear that this option would be desired by
prescribers, some of whom have indicated that they do not have time
during business hours to respond to these requests or that such
calls tie up their phone lines. See NPRM, 81 FR 88539 n.158. \345\ Id.; see also CLR Panel IV Tr., supra note 121, at 10
(statement of David Cockrell that the office needs to be able to
contact the seller immediately and it ``can't even leave a
message''). \346\ CooperVision, Inc. (SNPRM Comment #130). \347\ CooperVision also stated confusion as to whether the
Commission's requirement for sellers to provide an option to repeat
the verification information included a requirement for sellers to
provide the means for the prescriber to immediately disrupt an
automatic call in order to connect with a live person. SNPRM Comment
#130. It does not.
--------------------------------------------------------------------------- The Rule does not require sellers' communication via telephone,
email, or fax to occur during business hours. The Rule requires,
instead, that sellers wait eight business hours after a valid
verification call to sell the lenses. Moreover, the Rule already
requires the seller to provide the name of a contact person at the
seller's company, including facsimile and telephone numbers.\348\
Should a prescriber inform the seller within eight business hours that
the prescription was inaccurate, expired, or otherwise invalid, the
seller cannot lawfully sell those contact lenses. If a prescriber
informs a seller that the verification request itself was non-
compliant, the seller is on notice that it may need to provide another
verification request prior to selling the lenses. The prescriber need
not relay that information to a person at the seller, whether during
the verification
[[Page 50693]]
call or at other times.\349\ Instead, it is sufficient notice for a
prescriber to leave a voicemail, or send a facsimile, that provides the
seller with enough information so as to identify the consumer or order
being called about (a consumer name, reference number, or even the
prescriber's name with the date of the verification call could be
adequate), and that the prescription is inaccurate, expired, or
otherwise invalid.\350\ In addition, requiring sellers to reach a
person (and not a machine) at the prescriber's office, or to provide a
call-back number that is answered by a person (and not a machine),
would mean either that sellers would need to have agents available at
all times, or else only contact prescribers during business hours for
both the seller and prescriber, which may be difficult if they are
located in different time zones. Requiring that sellers have someone
available at all times to respond to prescriber inquiries would also be
costly for sellers, with no readily apparent countervailing benefit.
For these reasons, the Commission declines to implement a requirement
that sellers ensure that automated telephone messages are answered by a
person at the prescriber's office, as opposed to a recording device, or
that prescribers be able to reach a live person at the seller.\351\
--------------------------------------------------------------------------- \348\ 16 CFR 315.5(b)(6). \349\ If a seller does not maintain a person to answer the phone
number it provides, it must provide an opportunity for the
prescriber to leave a message. A seller that does not check its
voicemail runs the risk of selling lenses after a prescriber has
timely invalidated or corrected the prescription, thereby violating
the Rule. \350\ Final Rule Sec. 315.5(e) requires the prescriber to
specify the basis for the inaccuracy or invalidity of the
prescription, and if the prescription is inaccurate, the prescriber
shall correct it. Final Rule 16 CFR 315.5(e). Even if the prescriber
violates the Rule by failing to specify the basis for the inaccuracy
or invalidity, or by failing to correct the prescription, the seller
is still prohibited from selling if a prescriber informs the seller
that the prescription is inaccurate, expired, or otherwise invalid
within the eight-business-hour time period. \351\ The Commission notes that some sellers have agents who
stay on the line to ensure that, before commencing the automated
message, an individual at the prescriber's office has answered the
phone, or that the answering machine has picked up before leaving
the message. Such a practice helps ensure that the beginning of the
message is not cutoff or played over hold music.
--------------------------------------------------------------------------- The Health Care Alliance for Patient Safety and Johnson & Johnson
Vision Care further requested a requirement that online sellers verify
that they are making verification calls to the office of a legitimate
eye care professional. The Commission is aware of allegations of
sellers making verification calls to numbers clearly not affiliated
with eye care prescribers. The Rule requires a seller to sell contact
lenses in accordance with a contact lens prescription for the patient
that, if not presented to the seller, is verified by direct
communication.\352\ Of course, for prescription verification to be
meaningful, that verification must go to the consumer's eye care
prescriber. Although the seller does not know whether the prescriber
contact information provided by the consumer is that of the consumer's
own eye care prescriber, to ensure that its verification request
complies with the Rule, it is incumbent upon the seller to ascertain
whether the number provided by the consumer is for an eye care
prescriber. If it is apparent from the consumer's entry itself,\353\ or
from the seller's research on the internet or otherwise, that the
number provided is not affiliated with a prescriber, or if it cannot be
determined whether it is, the seller should either reach out to the
consumer to obtain better contact information or cancel the order.
Calls to numbers clearly not associated with eye care prescribers are
not compliant verification requests, and any sales made pursuant to
such requests violate the Rule. The Commission intends for this notice
to provide sufficient guidance for sellers and does not see a need to
amend the Rule to address this issue.
--------------------------------------------------------------------------- \352\ 16 CFR 315.5(a). \353\ For instance, sellers should not verify a prescription
when the consumer identifies the prescriber as ``Santa Claus.''
Similarly, sellers should not place verification calls to phone
numbers that consumers list as the prescriber phone number when that
phone number is the same number a consumer lists as her own contact
number.
--------------------------------------------------------------------------- The Commission is implementing the recommendations outlined in the
SNPRM for automated telephone messages in the Final Rule, without
modification. CooperVision requested guidance on how the Commission
intends to interpret and enforce these provisions.\354\ This notice
should provide sellers with information to assist them in complying
with the new rule requirements. The Commission also plans to publish
education on these Final Rule requirements. As to enforcement, should
the Commission receive complaints about the quality of automated calls,
it can request that the seller produce the recording of the call in
question.
--------------------------------------------------------------------------- \354\ CooperVision, Inc. (SNPRM Comment #130).
---------------------------------------------------------------------------
IV. Prescribers' Selection of Communication Mechanism In the NPRM, the Commission pointed out that the Act does not
permit prescribers to limit the communication mechanism sellers may use
to submit requests for verifying prescriptions, and that sellers are
able to use any or all of the three delineated methods, telephone,
facsimile, or electronic mail.\355\
--------------------------------------------------------------------------- \355\ NPRM, 81 FR at 88542.
--------------------------------------------------------------------------- In response, prescribers continued to request that they be able to
select the method of communication used to submit verification requests
from among telephone, facsimile, or electronic mail.\356\ Johnson &
Johnson Vision Care commented that it wished to work with the
Commission and Congress to improve prescriber-seller communications,
such as by allowing a prescriber to select her preferred method for
verification requests.\357\ The AOA commented that the Commission took
a step in the right direction when it suggested that sellers evaluate
whether honoring prescriber preferences with regard to communication
method would increase the speed and efficiency of the verification
process.\358\ It nevertheless urged the Commission to provide more
instruction to sellers, and to outline the verification-related
complaints that the Commission has received, so prescribers and sellers
can work together to ensure patients receive the contact lenses that
were prescribed.\359\
--------------------------------------------------------------------------- \356\ O'Daniel (NPRM Comment #179); Krattli (NPRM Comment
#1976). \357\ Johnson & Johnson Vision Care, Inc. (NPRM Comment #4327).
The manufacturer also requested that sellers be required to provide
an option, as part of a verification message, for the prescriber's
office to elect an alternate means to receive the request, and an
alternate time frame after which the window to respond to
verification requests must be completed. Johnson & Johnson Vision
Care, Inc. (SNPRM Comment #151). \358\ American Optometric Association (NPRM Comment #3830). \359\ Id.
--------------------------------------------------------------------------- The Commission reiterates its suggestion that sellers and
prescribers work together to ensure that patients receive their
prescribed lenses. As stated in the NPRM, the Commission requests
sellers to consider whether the speed and efficiency of the
verification process would be increased by accommodating prescribers'
requests to contact them with verification requests via a certain
method.\360\ However, 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
[[Page 50694]]
use to submit verification requests.\361\ The Commission is therefore
not making any changes to the Rule in this area.
--------------------------------------------------------------------------- \360\ NPRM, 81 FR at 88542. Similarly, the seller should
consider whether to accommodate prescribers' requests to contact
them during specified time-periods (i.e., business hours, or after
business hours). \361\ See 15 U.S.C. 7603(g). The Commission came to the same
conclusion in its initial rulemaking. 69 FR at 40497. The Commission
recognizes that in practice, sellers' options may be limited. For
instance, should a prescriber's office not have facsimile, a seller
would be unable to complete a verification request via fax.
---------------------------------------------------------------------------
V. Miscellaneous Passive Verification Issues
A. Active Verification Is Not Required In the NPRM, the Commission declined to propose replacing passive
verification with active verification, despite concerns from many
commenters.\362\ Commenters expressed concern that the passive
verification system could easily be manipulated, for example, by a
patient who provides false or incorrect prescriber information to a
seller, or by a seller who sends the same verification request over and
over again in the hope that the prescriber will fail to reply and deny
one of them.\363\ However, because Congress decided to include a
passive verification system in the Act, and the issues commenters
raised were identical to those raised during the initial 2004
rulemaking, the Commission chose not to revisit the decision to include
passive verification.\364\
--------------------------------------------------------------------------- \362\ NPRM, 81 FR at 88543. \363\ Id. \364\ Id.
--------------------------------------------------------------------------- Following the NPRM, many commenters reiterated the same concerns
with respect to passive verification, including that sellers could
abuse the system or that consumers might obtain lenses without a
prescription or receive incorrect lenses, and they advocated for a
switch to active verification.\365\ Because these concerns are similar
to those raised during the initial rulemaking in 2004 and because
Congress mandated passive verification in the FCLCA, the Commission
again declines to modify the Rule to require active verification.\366\
However, the Commission has made several changes to the Rule aimed at
improving the quality of automated verification calls, which will allow
prescribers to more effectively prevent the sale of contact lenses when
the prescription is inaccurate, expired, or otherwise invalid.\367\ The
Commission has also improved patients' access to their prescriptions by
implementing requirements enabling patients to obtain electronic copies
and additional copies of their prescriptions, and to present their
prescriptions directly to sellers, which should reduce the need for
passive verification requests.\368\ The Commission recognizes that some
sellers may engage in verification practices that violate the Rule's
requirements \369\ and, for that reason, will continue to monitor the
marketplace and investigate potential violations when appropriate.
--------------------------------------------------------------------------- \365\ See, e.g., Golden (WS Comment #1353); Weidel (WS Comment
#2333); Gray (WS Comment #2730); Audia (NPRM Comment #698); Bazan
(NPRM Comment #706); Dewart (NPRM Comment #897); Nixon (NPRM Comment
#1510); Weissman (NPRM Comment #1676); Goshe (NPRM Comment #2597);
Fritsch (NPRM Comment #2683); Garr (NPRM Comment #2858); Phan (NPRM
Comment #3350). Some commenters continued to support passive
verification. See 1-800 CONTACTS (WS Comment #3207); National
Association of Optometrist and Opticians (WS Comment #3208) (``No
changes are needed to the passive verification system.''). \366\ The Commission also notes that nothing in the Rule
prevents active verification by a seller. If it prefers, a seller
can choose to actively verify a prescription. CLR Panel IV Tr.,
supra note 121, at 5 (statement of Jennifer Sommer) (stating that
Walmart often actively verifies prescriptions by calling the
prescriber's office). \367\ See Section III, supra; 16 CFR 315.5(c)(2), (d). \368\ See Section II.C.5, supra, and Sections VII and VIII,
infra. \369\ 16 CFR 315.5(a)-(d).
---------------------------------------------------------------------------
B. Concerns About Patient Manipulation In the NPRM, the Commission declined to propose any changes to the
Rule to address concerns that patients were manipulating the passive
verification system by deliberately providing inaccurate prescriber
information to the seller.\370\ The Commission noted that if
prescribers received a verification request for an individual who was
not their patient, they have the ability to respond that such request
is invalid, which would prevent the sale under Sec. 315.5 of the Rule.
Some commenters provided anecdotal evidence of instances where
consumers have intentionally provided inaccurate information, but the
Commission did not have any empirical evidence showing the frequency of
this problem.\371\ Moreover, Congress was aware that passive
verification was not a foolproof method to prevent verification of
invalid prescriptions, but nonetheless mandated passive verification to
balance the interests of consumer health and prescription portability.
--------------------------------------------------------------------------- \370\ NPRM, 81 FR at 88543. \371\ Id.
--------------------------------------------------------------------------- In response to the NPRM, commenters continued to express concerns
with patients being able to obtain contact lenses without a valid
prescription, especially with only eight business hours to respond to a
verification request, and with the potential health consequences.\372\
To address concerns with patient manipulation of passive verification,
commenters advocated using an active verification system, requiring
that a prescription be presented, changing the method used to send
verification requests, or increasing the amount of time for a
prescriber to respond.\373\
--------------------------------------------------------------------------- \372\ See, e.g., Johnson & Johnson Vision Care, Inc. (SNPRM
Comment #151); Lem (WS Comment #470); Dillehay (WS Comment #822);
Baird (WS Comment #1918); Hemler (WS Comment #2312); Patel (WS
Comment #2691); Gray (WS Comment #2730); Bottjer (WS Comment #3378);
Tuttle (NPRM Comment #161); Gilberg (NPRM Comment #198); Moy (NPRM
Comment #382); Engler (NPRM Comment #453); Francis (NPRM Comment
#588); Stott (NPRM Comment #687); Kempf (NPRM Comment #915);
McPherson (NPRM Comment #3397); Schlater (NPRM Comment #3504);
Bengoa (NPRM Comment #3600); Jackson (NPRM Comment #3736). \373\ See, e.g., Contact Lens Association of Ophthalmologists,
Inc. (WS Comment #770); Northsight Vision Care Center (WS Comment
#1196); Golden (WS Comment #1353); Begeny-Mahan (WS Comment #1702)
(requesting that the eight-business-hour period be changed to forty-
eight hours); Kirkconnell (WS Comment #1754) (requesting two
business days to respond and stating that requests should be faxed);
American Society of Cataract and Refractive Surgery (WS Comment
#3142) (advocating for extending the eight-business-hour time-period
for passive verification to five business days); Bazan (NPRM Comment
#706); Garr (NPRM Comment #2858); Greitzer (NPRM Comment #3388).
--------------------------------------------------------------------------- The Commission recognizes prescribers' concerns about the potential
health effects on patients who wear non-prescribed lenses. However, as
noted in the NPRM, Congress chose the passive verification framework as
a way to balance consumer health and prescription portability.\374\
Congress also allowed verifications by direct communication, which it
defined as including telephone, facsimile, and electronic mail.\375\
Congress was aware that passive verification was not a perfect method
to prevent patients from deliberately providing incorrect
information.\376\ The Commission does not have any evidence, aside from
anecdotal reports, showing the extent to which patients are
intentionally providing incorrect information to a seller in order to
obtain contact lenses. Thus, the Commission does not believe that
significant modifications to the Rule to address the concern about
consumers submitting inaccurate prescriber information are warranted.
--------------------------------------------------------------------------- \374\ NPRM, 81 FR at 88543. \375\ 15 U.S.C. 7603. \376\ NPRM, 81 FR at 88543.
--------------------------------------------------------------------------- However, in its Final Rule, the Commission has implemented several
changes to improve verification calls that use an automated telephone
system, which will make it easier for prescribers to deny requests
based on inaccurate prescriber information. These changes
[[Page 50695]]
include identifying at the start of the call that it is a prescription
verification request, delivering the information in a slow and
deliberate manner and at a reasonably understandable volume, and giving
the prescriber the option to repeat the call.\377\ Prescribers will be
better able to identify the relevant patient information and inform
sellers during the eight-business-hour period that the request is
invalid.\378\ The Commission will also continue to monitor the
marketplace, investigate any sellers encouraging patients to provide
false information, and continue its consumer education efforts
communicating the importance of having a prescription when purchasing
contact lenses.\379\
--------------------------------------------------------------------------- \377\ See Section III. \378\ 16 CFR 315.5(d). \379\ See, e.g., Federal Trade Commission, Halloween know-how:
Cosmetic contacts require an Rx, https://www.consumer.ftc.gov/blog/2019/10/halloween-know-how-cosmetic-contacts-require-rx; Federal
Trade Commission, Prescription Glasses and Contact Lenses, https://www.consumer.ftc.gov/articles/0116-prescription-glasses-and-contact-lenses (``All contact lenses--even ones just meant to change your
appearance--require a prescription.'').
---------------------------------------------------------------------------
C. Eight-Business-Hour Time Frame Is Appropriate In the NPRM, the Commission considered commenters' concerns that
the eight-business-hour time frame was too short and that verification
calls were being placed outside of business hours or when the
prescriber's office was closed.\380\ The Commission declined to
lengthen or otherwise modify the eight-business-hour time frame during
which a prescriber must respond to a verification request.\381\ The
Commission did not find sufficient evidence quantifying how the eight-
business-hour time frame imposed a significant burden or showing that a
significant number of prescribers were unable to respond to the
verification requests within the allotted time. The Commission further
noted that there have been no compelling changes to the marketplace
since the Rule was implemented in 2004 that would justify extending the
period beyond eight business hours.
--------------------------------------------------------------------------- \380\ NPRM, 81 FR at 88544-5. Other concerns about passive
verification, unrelated to the length of time a prescriber has to
respond to a verification request, are addressed in Sections III,
IV, and V.A and B. \381\ Id.
--------------------------------------------------------------------------- In response to the NPRM, some commenters indicated that eight
business hours constituted a sufficient period for a prescriber to
respond to a verification request.\382\ However, other commenters
continued to express concerns with the limited time frame,\383\
particularly due to the potential negative health consequences for
patients wearing non-prescribed lenses, should a prescriber fail to
deny an invalid verification request in time.\384\ Many prescribers
wrote that eight business hours was just not a sufficient amount of
time to respond due to, for example, busy offices, limited staff, high
volume of requests, and regular office closures on business days.\385\
--------------------------------------------------------------------------- \382\ Coalition for Contact Lens Consumer Choice (WS Comment
#3239); Consumer Action (NPRM Comment #3721); Consumers Union (NPRM
Comment 3969) (stating that eight business hours ``was generally
sufficient and has proven workable,'' but suggesting that the period
could be changed to twenty-four hours with weekends and holidays
excluded); see also CLR Panel IV Tr., supra note 121, at 16
(statement of Cindy Williams) (stating that eight hours is
sufficient time to respond). \383\ See, e.g., Becker (WS Comment #571); Contact Lens
Association of Ophthalmologists, Inc. (WS Comment #770); Begeny-
Mahan (WS Comment #1702) (requesting that the eight-business-hour
period be changed to forty-eight hours); Kirkconnell (WS Comment
#1754) (requesting two business days to respond and stating that
requests should be faxed); American Society of Cataract and
Refractive Surgery (WS Comment #3142) (advocating for extending the
eight-business-hour time-period for passive verification to five
business days); Hanen-Smith (NPRM Comment #154); Cade (NPRM Comment
#2163) (suggesting that sellers should exclude a weekday from the
eight-business-hour calculation if they become aware that the
prescriber's office is closed); American Academy of Opthalmology
(NPRM Comment #3657) (proposing lengthening the response period to
two business days); Coalition for Patient Vision Care Safety (NPRM
Comment #3883); Contact Lens Association of Ophthalmologists (NPRM
Comment #4259) (asking that the period be extended to two days). \384\ See, e.g., Rhee (WS Comment #3468); Meyers (NPRM Comment
#173); Gilberg (NPRM Comment #198); Engler (NPRM Comment #453);
Kempf (NPRM Comment #915); McPherson (NPRM Comment #3397); American
Society of Cataract and Refractive Surgery (NPRM Comment #3820);
Tesinsky (NPRM Comment #4012). \385\ Boyer (SNPRM Comment #59); Becker (WS Comment #571)
(recommending two business days); Contact Lens Association of
Ophthalmologists, Inc. (WS Comment #770); Begeny-Mahan (WS Comment
1702) (stating that the eight-hour period is a problem because the
office is closed on Wednesdays); Huynh (WS Comment #1940); Dhaliwal
(WS Comment #2684); American Society of Cataract and Refractive
Surgery (WS Comment #3142); Morales (WS Comment #3404); Yu-Davis (WS
Comment #3410), Rhee (WS Comment #3468); Meyers (NPRM Comment #173);
Pierce (NPRM Comment #187) (estimating that the office spends
approximately twelve minutes responding to a verification request);
Kempf (NPRM Comment #915) (stating that the office is closed on
Wednesdays and incorrect prescriptions received late on Tuesday will
be filled); Goodman (NPRM Comment #1340) (stating that the
prescriber is unable to respond to requests within the eight-hour
period because the office is closed on Mondays); Speiser (NPRM
Comment #2233) (stating that eight hours are not enough time because
the doctor spends time at the hospital and is not in the office
every day); Weingeist (NPRM Comment #2496) (stating that the
practice is small and the requests are burdensome); American Society
of Cataract and Refractive Surgery (NPRM Comment #3820); McPherson
(NPRM Comment #3397) (stating that the office is very busy with
patients and verification requests can be forgotten).
--------------------------------------------------------------------------- The Commission considered these comments and, for the reasons
stated in the NPRM, declines to change the eight-business-hour period,
including by lengthening the period or changing how the period is
calculated. Congress mandated the verification system and that a
prescriber respond within ``8 business hours, or a similar time as
defined by the Federal Trade Commission.'' \386\ In determining this
time period, Congress balanced the harm to consumers if they were
unduly delayed in receiving their contact lenses against the harm from
receiving contact lenses based on an invalid prescription.\387\ The
Commission does not find any compelling changes to the marketplace
since the Rule's promulgation in 2004 that support extending the eight
business hour period.\388\
--------------------------------------------------------------------------- \386\ NPRM, 81 FR at 88544. Some prescribers or sellers may be
confused about when the eight-business-hour period starts following
a verification request and the applicable time zone. See, e.g.,
Goodman (WS Comment #599); Palmer (WS Comment #2215); Wang (WS
Comment #3448); Gilberg (NPRM Comment #198); Huff (NPRM Comment
#1964); Osterholzer (NPRM Comment #2085) (stating that the office is
not open during the same hours as the seller and in a different time
zone). Under the Rule, when a request is received after 5 p.m., the
eight-business- hour period would not start until 9 a.m. the next
weekday that is not a federal holiday, or if applicable, on Saturday
at the beginning of the prescriber's actual business hours. A
business hour is determined based on the time zone of the
prescriber. 16 CFR 315.2, 315.5. \387\ NPRM, 81 FR at 88544. \388\ The Commission recognizes a need for clarification with
respect to whether a seller can ship lenses to a consumer after
receiving notification from a prescriber that the submitted
prescription is inaccurate, invalid, or expired but when such
notification occurs after the eight-business-hour period has passed.
In its initial rulemaking, the Commission declined to expressly
prohibit sellers from shipping lenses in such an instance, but noted
that nothing in the Rule prohibits a prescriber from submitting late
notifications to the seller or the seller from acting upon them, and
that it would likely be in the best interest of their mutual
consumer for them to do so. Contact Lens Rule, 69 FR 40050. However,
the Commission is aware that the marketplace for contact lens sales
now includes subscription models, in which sellers provide a
quantity of lenses to consumers, not in a single-delivery supply,
but rather in periodic installments (usually every month, although
sometimes quarterly or semi-annually). In such a circumstance, the
seller would have plenty of time to halt a subsequent installment
shipment after being informed that the consumer's prescription was
invalid, inaccurate, or expired. Therefore, the Commission clarifies
that while the Rule does not prohibit an initial shipment to a
consumer in instances where the seller received such notification
after the eight-business-hour period has passed, any subsequent
shipments based on the initial verification request would violate
the Rule. A seller who has been notified that the patient does not
have a valid prescription cannot ignore such notification and
continue to sell and ship lenses every month simply because the
notification came in after the eight-business-hour deadline.
---------------------------------------------------------------------------
[[Page 50696]]
VI. Seller Alteration of Contact Lens Prescriptions and Private Label
Concerns The current Rule states that a ``seller may not alter a contact
lens prescription.'' The only exception applies to private label
contact lenses and allows the seller, when a patient has a prescription
for private label contact lenses, to substitute identical contact
lenses that the same company manufactures and sells under a different
name.\389\
--------------------------------------------------------------------------- \389\ 16 CFR 315.5(e).
--------------------------------------------------------------------------- In the SNPRM, the Commission expressed its concern about the
emergence of sellers' business models that rely exclusively on passive
verification as a means to substitute their own brand of contact lenses
for the prescribed lens.\390\ As noted in the SNPRM, many prescribers
detailed harm that resulted from wearing unprescribed lenses, such as
headaches, corneal neovascularization, corneal ulcers, and other
irreversible and vision-threatening diagnoses.\391\ As a result, the
Commission proposed two modifications to the Rule.
--------------------------------------------------------------------------- \390\ SNPRM, 84 FR at 24687-88. \391\ Id. at 24686.
--------------------------------------------------------------------------- The first modification proposed in the SNPRM, adding a paragraph
(g) to Sec. 315.5, would require sellers to provide a clear and
prominent method for the patient to present the seller with a copy of
the patient's prescription. Such method might include, without
limitation, electronic mail, text message, file upload, or facsimile.
The Commission stated that this proposal would address prescriber and
manufacturer concerns by increasing the number of patients who present
online sellers with their prescriptions rather than relying on
verification.\392\
--------------------------------------------------------------------------- \392\ Id. at 24688.
--------------------------------------------------------------------------- The second modification proposed in the SNPRM targeted concerns
about prescription verification more directly. The proposed
modification of Sec. 315.5(f) would define alteration to include a
seller's providing, as part of a verification request, a prescriber
with a manufacturer or brand other than that specified on a patient's
prescription. The proposal included an exception, however, for sellers
when they provide a manufacturer or brand that a patient provided to
the seller, either on the order form or orally in response to a request
for the manufacturer or brand listed on the prescription. In other
words, to avail themselves of the exception, sellers must ask consumers
to provide the manufacturer or brand listed on their prescription. The
SNPRM further provided that a seller would not be able to avail itself
of the exception by relying on a prepopulated or preselected box, or on
consumers' online searches for a particular manufacturer or brand, as
an indication that they were prescribed that manufacturer or
brand.\393\ A seller not covered under the exception discussed above
who made a verification request containing a manufacturer or brand
other than, and not identical to, the one written on the consumer's
prescription by their prescriber, would violate the Rule, even if a
prescriber subsequently invalidated the request and the lenses were
never sold.\394\
--------------------------------------------------------------------------- \393\ Id. at 24689. \394\ Id.
---------------------------------------------------------------------------
A. The Final Rule Includes a Requirement for Sellers To Accept
Prescription Presentation Commenters who discussed the Commission's proposal to require
sellers to provide a clear and prominent method to present
prescriptions were unanimous in their support, although some suggested
revisions that they believed would make it more effective.\395\ A
number of commenters asserted that this amendment would help decrease
the number of verification requests \396\ and eliminate errors stemming
from incorrect verification requests.\397\ In addition, the NAOO
pointed out that such presentation benefits the consumer and the seller
by reducing the time needed to fill the order and providing additional
assurance of the prescription's validity.\398\ 1-800 CONTACTS also
supported--and says that it already complies with--the prescription
presentation proposal.\399\ Simple Contacts commented that the proposed
requirement is fair, and opined that ``any seller who does not support
prescription presentation has not made a good faith attempt to
accurately verify all patient prescriptions.'' \400\ Simple Contacts,
however, expressed skepticism that the amendment would significantly
reduce the number of alterations by sellers abusing the passive
verification system.\401\
--------------------------------------------------------------------------- \395\ Simple Contacts (SNPRM Comment #87); American Optometric
Association (SNPRM Comment #96); Health Care Alliance for Patient
Safety (SNPRM Comment #128); National Association of Optometrists
and Opticians (SNPRM Comment #129); 1-800 CONTACTS (SNPRM Comment
#135); Johnson & Johnson Vision Care, Inc. (SNPRM Comment #151). \396\ Health Care Alliance for Patient Safety (SNPRM Comment
#128); National Association of Optometrists and Opticians (SNPRM
Comment #129); Johnson & Johnson Vision Care, Inc. (SNPRM Comment
#151). \397\ Health Care Alliance for Patient Safety (SNPRM Comment
#128); National Association of Optometrists and Opticians (SNPRM
Comment #129); 1-800 CONTACTS (SNPRM Comment #135); Johnson &
Johnson Vision Care, Inc. (SNPRM Comment #151). \398\ National Association of Optometrists and Opticians (SNPRM
Comment #129). \399\ 1-800 CONTACTS (SNPRM Comment #135). \400\ Simple Contacts (SNPRM Comment #87). See also National
Association of Optometrists and Opticians (SNPRM Comment #129)
(``Contact lens sellers that do not provide a method to upload the
prescription may be trying to avoid getting the patient's specific
brand information, so that they can switch the patient into a
different proprietary brand.''). \401\ Simple Contacts (SNPRM Comment #87). The Health Care
Alliance for Patient Safety stated that ``it is unclear whether the
proposed amendment would have any effect on the incidence of
alteration[s]'' since the Commission is not also prohibiting calls
containing automated verification messages. SNPRM Comment #128.
--------------------------------------------------------------------------- Because the Commission did not receive any comments opposing this
proposal, the Commission is incorporating the requirement in its Final
Rule. The Commission believes the proposal will help reduce the number
of verifications, reduce errors associated with incorrect verification
attempts, and make it more difficult for ill-intentioned sellers to
abuse the passive verification framework and take advantage of
consumers who might not realize that the seller intends to verify a
different lens than the one written on their prescription. In the Final Rule, the Commission has changed the ``clear and
prominent'' requirement to pertain to a disclosure of the method of
prescription presentation (e.g., a disclosure that the method is
available to provide the prescription). In so doing, the Commission
makes clear that sellers cannot provide a method of prescription
presentation without also providing a clear and prominent disclosure
thereof.\402\ The Commission has retained the requirement that the
method (e.g., email address, phone number to receive text messages, or
upload link) be prominent.\403\ The Commission has also determined that
it is unnecessary to include prescribers in this section of the Rule
since it pertains to the ordering process between a seller and a
consumer.\404\
--------------------------------------------------------------------------- \402\ For telephone orders, sellers would comply by making a
prominent method available and giving clear and prominent notice of
the method. \403\ The Commission finds its proposed SNPRM requirement that
the method be clear unnecessary given the new language requiring the
disclosure of the method to be clear and prominent. \404\ The Rule anticipates prescription presentation by
prescribers to sellers. Section 315.5(a)(1) indicates that one way
sellers can sell contact lenses is if they receive a prescription
from a prescriber directly or by facsimile. 16 CFR 315.5(a)(1).
--------------------------------------------------------------------------- Commenters suggested three additional requirements for the
prescription presentation proposal. First, the NAOO suggested the
[[Page 50697]]
Commission require that the method to present prescriptions be in close
proximity to the option to provide the parameters of the contact lens
for verification, so as to increase the likelihood that consumers would
understand they have a choice between providing a prescription or
having one verified with their prescriber.\405\ As drafted, the
language did not specify at what point in the process a seller must
make the method for prescription presentation available. The Commission
believes that the NAOO's suggestion of close proximity would be
helpful, but notes that if the method, and a disclosure thereof, are
provided in close proximity but after the collection of all information
required for verification is provided, the prescription presentation
benefit may be diminished. In other words, if a consumer enters all the
information required for verification (contact lens brand, powers,
prescriber name and phone number) before learning about prescription
presentation, and having an opportunity to present the prescription,
the consumer may choose not to also provide the prescription. As a
result, the Commission is amending the language of Sec. 315.5(g) in
the Final Rule to require that the method and the disclosure of the
method for the patient to present the seller with a copy of the
patient's prescription must be prior to requesting a prescriber's
contact information, which is necessary to verify a contact lens
prescription.\406\
--------------------------------------------------------------------------- \405\ National Association of Optometrists and Opticians (SNPRM
Comment #129). \406\ In the case of orders placed by telephone, the Rule
requires sellers to provide clear and prominent disclosure of the
method for prescription presentation (e.g., a seller's email
address) prior to requesting a prescriber's contact information.
--------------------------------------------------------------------------- Two commenters opined on whether consumers should be able to choose
the method for providing their prescriptions. Consumer Reports stated
its belief that, when offering prescription presentation, sellers
should be required to provide consumers all four methods listed in the
proposed Rule--electronic mail, text message, file upload, and
facsimile--in lieu of giving sellers the option to choose from those
methods.\407\ It indicated that requiring all four would not burden the
seller, and there may be reasons that patients prefer one option over
the others.\408\ On the other hand, the NAOO supported the Commission's
proposal to let the seller decide the method.\409\ The Commission has
decided to require sellers to offer prescription presentation by the
same medium through which the order is placed, or by electronic mail,
text message, or file upload.\410\ When orders are placed via
telephone, sellers are required to offer prescription presentation via
electronic mail, text message, or file upload. Because faxes are not
commonly used by consumers, sellers can offer fax presentation as the
sole option only when the orders are placed by fax. This framework
gives consumers and prescribers an opportunity to present
prescriptions, while limiting the burden on sellers, some of whom are
small.\411\ The Commission believes that these changes from the SNPRM
proposal are not significant, are consistent with the stated purpose of
the proposal as outlined in the SNPRM,\412\ and will help ensure the
maximum benefit from the Rule change.
--------------------------------------------------------------------------- \407\ Consumer Reports (SNPRM Comment #133). \408\ Id. \409\ National Association of Optometrists and Opticians (SNPRM
Comment #129). \410\ A seller who chooses to offer all methods will likely
benefit by having more consumers provide prescriptions than if it
offered only one or even two methods. Benefits to sellers from
having prescriptions on file include avoiding the costs involved in
verification, and having the ability to provide contact lenses more
quickly than relying on verification. \411\ For all orders, sellers can meet the requirement by
accepting prescriptions via email. There should not be a significant
burden on business to obtain and maintain an email address and
process and store prescriptions received through email. \412\ SNPRM, 84 FR at 24688-89.
--------------------------------------------------------------------------- Consumer Reports also recommended that sellers be required not just
to accept prescription presentation, but also to specifically request
and encourage patients to provide prescriptions.\413\ The Commission
declines to adopt this suggestion. The Commission's Final Rule requires
sellers to accept prescriptions. The Final Rule also requires that
sellers clearly and prominently disclose how consumers can provide them
with prescriptions. Sellers that more overtly request or encourage the
submission of prescriptions (e.g., through price cuts and faster
delivery times) will likely further increase the number of
prescriptions presented, allowing both sellers and consumers to reap
the benefits. However, the Commission has determined that beyond
providing a method for consumers to present their prescriptions and
notice of such method prior to requesting their prescriber's contact
information, sellers should have discretion whether to promote or
incentivize that practice.
--------------------------------------------------------------------------- \413\ Consumer Reports (SNPRM Comment #133).
---------------------------------------------------------------------------
B. Alteration Includes a Seller Providing a Prescriber With a
Verification Request for a Non-Prescribed Manufacturer or Brand, but
Includes an Exception for Verifying a Manufacturer or Brand That a
Consumer Indicates Is on Her Prescription In the SNPRM, the Commission proposed a modification of Sec.
315.5(f) to define alteration to include a seller's providing, as part
of a verification request, a prescriber with a manufacturer or brand
other than that specified on a patient's prescription. The proposal
included an exception, however, for sellers when they provide in a
verification request a manufacturer or brand that a patient provided to
the seller, either on the order form or orally in response to a request
for the manufacturer or brand listed on the prescription.\414\ As
discussed below, in the Final Rule, the Commission has determined to
adopt this definition of alteration along with a modified version of
the accompanying exception.
--------------------------------------------------------------------------- \414\ SNPRM, 84 FR at 24698.
---------------------------------------------------------------------------
1. The Final Rule Modifications Regarding Alteration Are Beneficial and
Address Abuses of the Verification System 1-800 CONTACTS expressed its belief that the proposed alteration
modification was unnecessary and requested that the Commission
carefully evaluate any new regulations that could interfere with the
convenience and competitive pricing of legitimate sellers.\415\
Although the seller recognized the presence of single-brand sellers in
the market, and the problems some cause, 1-800 CONTACTS stated that the
addition of quality standards for verification calls, along with
targeted enforcement against sellers with a business model based solely
on noncompliant verification methods, would reduce the ability of these
sellers to profit from abusing the passive verification system.\416\
Specifically, it felt that ``enforcement against one such business [ ]
would likely be sufficient to chill or completely eliminate replication
of this business model.'' \417\ The Commission agrees that the
requirement to provide a method for prescription presentation, and a
disclosure thereof, should reduce the number of verification requests,
and that the addition of quality standards for verification calls
should reduce the incidence of non-compliant verification calls and
increase the ability of prescribers to deny invalid requests or
[[Page 50698]]
correct inaccurate ones. However, based on comments from prescribers as
well as its own investigations and experience, the Commission believes
those amendments on their own are inadequate to curb the practice of
substitution to non-prescribed brands through abuse of the verification
system. The Commission has previously stated that, under the existing
Rule, a verification request is not valid and does not commence the
eight-business-hour verification period if a seller knows or should
know that the verification request includes a different brand and
manufacturer than that prescribed.\418\ Any sales after such requests
violate the Rule, even if a prescriber has not responded. In these
instances, the seller is not selling in accordance with a prescription.
Despite clearly articulating this position, the FTC continues to
receive reports about the proliferation of passive verification abuses.
Furthermore, sellers may argue that they are technically compliant with
the Rule because they submitted verification requests and prescribers
had an opportunity to respond to the requests. They may also argue that
they did not have knowledge that a consumer did not have a prescription
for that manufacturer or brand of lens.
--------------------------------------------------------------------------- \415\ 1-800 CONTACTS (SNPRM Comment #135). \416\ Id. \417\ Id. \418\ SNPRM, 84 FR at 24687-88.
--------------------------------------------------------------------------- Additionally, this is not an issue of one bad actor. As noted in
the SNPRM, the Commission has seen the emergence of businesses that
rely exclusively, or almost exclusively, on passive verification as a
means to substitute their own brand of contact lenses.\419\ Simple
Contacts' comment notes that, within the last two years, several new
companies have entered the U.S. market and that their abuse of the
verification system appears willful.\420\ The AOA similarly noted an
increase of direct-to-consumer brands and named three new market
entrants that reportedly replace their own brand of lenses for the
prescribed brand.\421\ The Commission therefore sees benefits to
defining alteration to include a seller's providing a prescriber, as
part of a verification request, with a manufacturer or brand other than
that specified on a patient's prescription.
--------------------------------------------------------------------------- \419\ SNPRM, 84 FR at 24687. \420\ Simple Contacts (SNRPM Comment #87). \421\ American Optometric Association (SNPRM Comment #96).
---------------------------------------------------------------------------
2. Comments Related to the Exception to Alteration When a Seller
Provides the Manufacturer or Brand of Lenses That a Consumer Provides
in Response to a Seller's Request for That Information The SNPRM proposed that sellers receive an exception from
alteration when they provide, in a verification request, a manufacturer
or brand that a patient provided to them, either on the order form or
orally in response to a request for the manufacturer or brand listed on
the prescription.\422\ If the seller seeks to verify a manufacturer or
brand other than that indicated by the consumer, even if a prescriber
ultimately denies the request, the seller has committed a violation.
The implementation of the alteration definition, including the
exception, should serve as an effective deterrent against sellers that
try to game the verification system to sell non-prescribed contact
lenses.
--------------------------------------------------------------------------- \422\ SNPRM, 84 FR at 24686.
--------------------------------------------------------------------------- In response to the SNPRM, commenters expressed concerns that some
sellers might take advantage of the exception by inducing, suggesting,
advertising, or otherwise causing consumers to provide a name other
than that on their prescription so as to allow the seller to seek
verification of a brand that had not been prescribed for the
consumer.\423\ The NAOO was specifically concerned that ``less
scrupulous sellers'' would attempt to take advantage of this exception,
and noted that currently some sellers only request the power of the
lenses from the customer and then ask prescribers to verify a
prescription with a private label brand.\424\ Commenters proffered
different recommendations as to how to address this issue. CooperVision
requested that the Commission state in a guidance document that sellers
cannot induce, suggest, advertise, or otherwise cause patients to
provide the wrong name, and to provide examples of improper
statements.\425\ Johnson & Johnson Vision Care suggested that, should
the Commission retain the exception, it should add the following
clarifying language to the preamble section of the Rule: ``This
exception is intended to provide explicit direction for sellers as to
when they are responsible for instances of prescription alteration.
Under no circumstances may a seller, wishing to avail themselves of
this exception, direct, encourage, motivate, or suggest, either
implicitly or explicitly, that a patient enter any manufacturer or
brand other than that listed on the patient's prescription.'' \426\ The
NAOO recommended that the Rule itself be further amended to provide
more specific direction as to what the seller must, may, and cannot do
when asking patients for the information the FCLCA requires in a
verification request. Specifically, it recommended adding a requirement
that to avail itself of the exception, a seller must have had no reason
to believe that the name provided by the consumer was not the
manufacturer or brand listed on that consumer's prescription.\427\
--------------------------------------------------------------------------- \423\ National Association of Optometrists and Opticians (SNPRM
Comment #129); CooperVision, Inc. (SNPRM Comment #130); Johnson &
Johnson Vision Care, Inc. (SNPRM Comment #151). \424\ National Association of Optometrists and Opticians (SNPRM
Comment #129). \425\ CooperVision, Inc. (SNPRM Comment #130). \426\ Johnson & Johnson Vision Care recognized that the
exception could serve as guidance for sellers to determine whether
they are responsible for an illegal prescription alteration.
However, it believes the exception should not be added to the Rule
because a patient may not be able to correctly enter their
information given the nuances of a contact lens prescription and the
meaning of the different elements therein. Ultimately, Johnson &
Johnson Vision Care is concerned that the exception may contribute
to passive verification of an inaccurate prescription, and thus,
illegal substitution. SNPRM Comment #151. The Commission does not
believe that this concern is relevant to the exception, which
relates to a consumer only providing her manufacturer or brand. \427\ National Association of Optometrists and Opticians (SNPRM
Comment #129).
--------------------------------------------------------------------------- The Commission agrees that sellers must not induce, suggest,
advertise, or otherwise lead consumers to provide a manufacturer or
brand different from that listed on their prescriptions. The Commission
believes, however, that the recommended change is unnecessary because,
should a seller attempt to induce or trick the consumer into providing
the seller with a manufacturer or brand different from that listed on
the consumer's prescription, it would not be able to avail itself of
the exception. Any such conduct by the seller would call into question
whether the consumer had provided the seller with the manufacturer or
brand listed on her prescription in response to a clear request for
such information, as required by the Rule. Commenters expressed concern that the exception for patient
prescription entry would allow consumers to override their
prescriptions by providing a manufacturer or brand of contact lenses
other than that prescribed to them by their prescriber.\428\ Similarly,
one commenter stated that sellers should ensure that consumers
understand that they need to request the lens specified on their
prescription and, if consumers want a different lens,
[[Page 50699]]
sellers shall state prominently that consumers must discuss the request
with, and make the change through, their prescribers.\429\ The concern
that this amendment gives consumers permission to override their
prescriptions, including choosing a new brand, is unfounded. The
exception in no way gives consumers the ability to override
prescribers' prescriptions, and it does not change the prescriber's
ability to inform a seller that the prescription submitted for
verification is inaccurate, expired, or otherwise invalid.\430\ In
fact, by requiring sellers to ask consumers their manufacturer or brand
to meet the exception, the proposal is encouraging just the opposite--
inviting consumers to choose the brand prescribed for them. And, once
the seller receives a communication from the prescriber that the
prescription is invalid, it cannot sell the lenses without violating
the Rule. The Commission therefore does not see a need to require
sellers to inform consumers that if they want a different lens, they
must go to their prescribers. Asking consumers for the manufacturer or
brand listed on their prescriptions, and clarifying that sellers may
not induce, suggest, or otherwise cause consumers to select or provide
a manufacturer or brand other than that prescribed, should be adequate
to curtail much of the illegal alterations occurring through abuse of
the verification system. Moreover, the Commission has issued consumer
notices that indicate that if consumers wish to switch their brand of
lens, they need to contact their prescribers.\431\ The Commission will
continue its educational efforts in this area.
--------------------------------------------------------------------------- \428\ American Optometric Association (SNPRM Comment #96);
Health Care Alliance for Patient Safety (SNPRM Comment #128). \429\ CooperVision, Inc. (SNPRM Comment #130). \430\ Final Rule 16 CFR 315.5(e). Despite this prohibition,
substitution to another brand of lenses was always a risk with
passive verification, but it was a risk Congress considered before
instituting the verification framework set forth in the Act. See,
e.g., FCLCA Subcomm. Hearing, supra note 17 (statements of Howard
Beales, Federal Trade Commission); id. (statements of J. Pat
Cummings, American Optometric Association) (``And the problem with
passive verification is that people will get contact lenses without
a prescription.''). \431\ See, e.g., Federal Trade Commission, Prescription Glasses
and Contact Lenses, https://www.consumer.ftc.gov/articles/0116-prescription-glasses-and-contact-lenses (last visited Nov. 19,
2019).
---------------------------------------------------------------------------
3. Comments Regarding and Commission Guidance on Acceptable Methods for
Obtaining the Brand or Manufacturer Listed on Consumers' Prescriptions 1-800 CONTACTS expressed concern that the Commission's amendment
might interfere with its ability to improve the user experience. It
indicated that it sells hundreds of brands of lenses and offers
consumers a variety of methods to identify their brand, including drop-
down menus, a search box, and filters that display lenses by brand,
modality, and other parameters and that some consumers do not enter
their brand information on an order form.\432\
--------------------------------------------------------------------------- \432\ 1-800 CONTACTS (SNPRM Comment #135).
--------------------------------------------------------------------------- Simple Contacts asked for greater specificity on the acceptable
mechanisms for soliciting the contact lens brand or manufacturer, as a
way to prevent bad actors from finding mechanisms to circumvent the
intent of the Rule. Simple Contacts recommended limiting such
mechanisms to five: Providing verbal confirmation of the brand or
manufacturer; providing a copy of a prior prescription indicating the
brand or manufacturer; typing a selection into a free entry text or
search field; selecting a brand or manufacturer from a list or database
containing the majority of commercially available brands (e.g., a drop-
down menu), or providing a photo of a contact lens box.\433\
--------------------------------------------------------------------------- \433\ Simple Contacts (SNPRM Comment #87). The NAOO also stated
that a seller should be able to rely on a customer-provided
photograph of packaging of contact lenses for a current
prescription. SNPRM Comment #129.
--------------------------------------------------------------------------- Johnson & Johnson Vision Care opined that should the Commission
proceed with the exception, a seller should not be able to avail itself
of the exception by relying on a prepopulated or preselected box, or on
consumers' online searches for a particular brand or manufacturer, as a
representation by consumers that they do, in fact, have a prescription
for that brand or manufacturer. In contrast to the view expressed by 1-
800 CONTACTS and Simple Contacts, Johnson & Johnson Vision Care
requested the Commission prohibit drop-down menus and similar tools as
methods by which a seller could avail itself of the exception.\434\
--------------------------------------------------------------------------- \434\ Johnson & Johnson Vision Care, Inc. (SNPRM Comment #151).
--------------------------------------------------------------------------- The Commission agrees that greater specificity surrounding
acceptable methods would benefit sellers trying to comply with the
Rule, but recognizes the myriad of ways consumers can interact with
sellers to purchase lenses. Specifically, the Commission agrees that
the requirement to provide the manufacturer or brand if not orally,
then on an order form, imposes unnecessary limits for a consumer to
select her manufacturer or brand. As a result, it is removing the term
``order form'' from the Final Rule. However, while sensitive to
sellers' needs to create the best and most convenient consumer
experience, the Commission believes requiring that they ask for the
name of the manufacturer or brand listed on consumers' prescriptions
can still be done while providing a positive purchasing experience for
their customers. At a minimum, in order for sellers to consider the consumer's
indication of manufacturer or brand as adequate to qualify for the
exception, the manufacturer or brand must be: (1) Provided in response
to a seller's request for the manufacturer or brand listed on the
consumer's prescription, and (2) an affirmative statement or selection
by the consumer, not a preselected or prefilled entry (collectively
``the minimum criteria''). As to the first minimum criterion, a seller
cannot assume that a consumer who searches on the internet for a
specific manufacturer or brand of lens has a prescription for that
manufacturer or brand of lens. Similarly, a consumer's selection next
to a request for the manufacturer or brand the consumer wears or wishes
to purchase would be insufficient because a consumer may be wearing or
attempting to order a non-prescribed lens. In contrast, a seller can
reasonably rely on a consumer's entry of a manufacturer or brand in
response to a request for the ``manufacturer or brand listed on your
prescription.'' The second minimum criterion for sellers to qualify for
the exception is that they must elicit from the consumer an affirmative
statement or selection of the manufacturer or brand. A seller that
relies on a preselected, prechecked box stating ``I agree I have a
prescription for this brand,'' or something similar, would not qualify
for the exception to alteration. For telephone orders, the consumer
must state the name of the manufacturer or brand in response to a
seller's request for the manufacturer or brand listed on her
prescription.\435\ A seller can rely on a consumer-provided photograph
of a contact lens box or a copy of a prior prescription so long as the
seller meets the two minimum criteria listed above and obtains
additional information from the consumer or prescriber that the
consumer has a current prescription for that brand.\436\
--------------------------------------------------------------------------- \435\ A seller receiving an affirmative response to its request
``Do you have a prescription for this brand?'' would be unable to
meet the exception. \436\ The information from the prescriber or consumer would
provide the seller with a basis for the verification other than the
expired prescription. See Section X.B., supra and NPRM, 81 FR at
88546-67 (a seller may not use an expired prescription as the basis
for a verification request).
--------------------------------------------------------------------------- The Commission is not limiting the permissible methods for
obtaining
[[Page 50700]]
manufacturer or brand to meet the exception to only those discussed
above. The Commission instead is leaving sellers the option of deriving
other ways to elicit the prescribed manufacturer or brand, within the
guidelines discussed in this section. The Commission also declines to
add a preamble further explaining the ways for sellers to meet the
exception, but instead relies on this notice as guidance. 1-800 CONTACTS opined that the Commission should not refer to
``brand'' in the amendment to the Rule as that language does not appear
elsewhere in the Rule. It points out that the Rule defines a
prescription as including a ``material or manufacturer or both'' and
that the Commission's inclusion of the reference to brand imposes an
additional limit on consumer choice that the Act does not require. 1-
800 CONTACTS requested instead that the exception to the Rule be
applicable to ``providing the prescriber with the name of a
manufacturer or material other than that specified by the patient's
prescriber . . . .'' The reference to brand in the definition of
alteration and in the exception would indeed be the only references to
brand in the Rule. However, in practice, it appears many, if not most,
prescriptions list the manufacturer's brand, not the manufacturer or
material, and the brand is viewed as shorthand for the entire
device.\437\ Furthermore, very few consumers know the manufacturer or
material of contact lens that they wear, and typically refer to their
lenses by brand name. Amending the exception in the way 1-800 CONTACTS
recommended would be unworkable since many consumers would be unable to
provide the manufacturer or material in response to a seller's request,
and might even have to ask their prescribers. Should prescribers'
practices change from listing a brand on a prescription to listing a
manufacturer or material, the Commission will reevaluate its decision.
--------------------------------------------------------------------------- \437\ SNPRM, 84 FR at 24686 n.299. See also National Association
of Optometrists and Opticians (SNPRM Comment #129) (noting as an
example that many, if not most, prescriptions for My Day lenses
manufactured by CooperVision get written as ``My Day,'' not as
``CooperVision'' or ``CooperVision My Day'').
---------------------------------------------------------------------------
4. The Commission Is Not Imposing a Recordkeeping Requirement for
Sellers Related to the Exception Lastly, CooperVision strongly recommended that the Commission
reconsider its decision not to require sellers to keep records related
to the exception and noted that the Rule relies heavily on requiring
written evidence. CooperVision claimed that the lack of a recordkeeping
requirement would leave a gap that could be exploited, and would make
it difficult for the Commission to pursue enforcement against sellers
who violate the Rule.\438\ The Commission disagrees with this
assessment. Since the exception to alteration would be a defense for a
seller, the seller would have the burden of proof to show it met the
exception. Should the Commission believe that the seller has altered a
contact lens prescription and submitted a verification request for a
manufacturer or brand other than that indicated by a consumer, the
seller would need evidence that it meets the exception. Sellers who
determine not to maintain records do so at their own peril.
--------------------------------------------------------------------------- \438\ CooperVision, Inc. (SNPRM Comment #130).
---------------------------------------------------------------------------
C. Private Label Issues Although most contact lenses in the United States are sold under
national brand names (such as Acuvue Oasys, or Dailies Aquacomfort
Plus), some manufacturers distribute their lenses to prescribers and
retail sellers under private labels (such as Costco's Kirkland
Signature contact lens brand or LensCrafters 1-Day Premium contact
lenses). Private label contact lenses can be unique to one seller, or
the private label brand may be available at multiple unaffiliated
sellers.\439\ Despite the label, however, the lenses inside the
packaging are exactly the same as lenses sold under a national
brand.\440\
--------------------------------------------------------------------------- \439\ 2005 Contact Lens Report, supra note 14, at 14-15. \440\ For example, Costco's Kirkland Signature Premium Daily
Disposable lenses are the same as CooperVision MyDay disposable
lenses.
---------------------------------------------------------------------------
1. The Commission Adopts a Technical Amendment and Clarifies That the
Only Permissible Substitution Involves Private Label Lenses In Sec. 315.2, the Rule defines private label 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.'' \441\ The Rule also provides that
a prescription for private label contact lenses must include, in
addition to other required information, the name of the manufacturer,
trade name of the private label brand, and if applicable, the trade
name of equivalent brand name.\442\ The Rule's definition for a private
label lens prescription tracks the language of the Act.\443\
--------------------------------------------------------------------------- \441\ 16 CFR 315.2. \442\ Id. \443\ See 15 U.S.C. 7610(3)(H).
--------------------------------------------------------------------------- With respect to how sellers treat and substitute private label
lenses, however, the Commission recognized in the NPRM that the
construction of Sec. 315.5(e) of the Rule does not presently conform
to the language or intent of the Act.\444\ The clear language of the
Act allows sellers to substitute national brand name lenses for private
label lenses, and vice versa, so long as it is ``the same contact lens
manufactured by the same company and sold under multiple labels to
individual providers.'' \445\ The Rule, meanwhile, states that 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.'' \446\ The different
language of the Act thus allows sellers to substitute brand names for
identical private labels, and private labels for identical brand names,
while the Rule, as currently drafted, could be read to proscribe the
latter.
--------------------------------------------------------------------------- \444\ NPRM, 81 FR at 88552. \445\ 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 so long as the lenses are identical. \446\ 16 CFR 315.5(e).
--------------------------------------------------------------------------- To conform the Rule to the Act, the Commission proposed in the NPRM
to strike the words ``private label'' from Sec. 315.5(e), so it would
state that a seller may ``substitute for contact lenses specified on a
prescription identical contact lenses that the same company
manufactures and sells under different labels.'' \447\ The Rule's
definitions of a ``contact lens prescription'' and of a ``private label
contact lens'' would remain unchanged. The Commission made this
proposal after becoming aware that, in addition to prescribers, some
other sellers (such as Costco) now 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.
--------------------------------------------------------------------------- \447\ NPRM, 81 FR at 88552.
--------------------------------------------------------------------------- While the Commission's proposal was intended to clarify the Rule
and align it with the Act's intent, some commenters opposed the change
because they believed it could be interpreted as allowing substitution
beyond that of private label lenses.\448\ According to Johnson &
Johnson Vision Care, the
[[Page 50701]]
``private label'' modifier is necessary to provide guidance that the
only instance in which a seller can lawfully substitute lenses for
those written on a prescription is for identical private label lenses,
and that removing the words ``private label'' from the command section
of the Rule (leaving it only in the definitions section), will render
the term meaningless.\449\ The removal of this term is especially
problematic, according to the manufacturer, because illegal
substitution is a problem in the marketplace, and it could ultimately
cause undue, avoidable harm to patient eye health and vision
safety.\450\ Should the Commission choose to proceed with its removal
of the term ``private label'' from Sec. 315.5(e), Johnson & Johnson
Vision Care requested that the Commission explicitly clarify that such
removal does not allow for substitution beyond the scope of private
label lenses or identical contact lenses that the same company
manufactures and sells under different labels. It further suggested
that the most appropriate and effective place to clarify how the
Commission interprets this Rule provision would be in the preamble of
the Rule, rather than the regulatory language itself.\451\
--------------------------------------------------------------------------- \448\ Johnson & Johnson Vision Care, Inc. (NPRM Comment #4327);
see also Tesinsky (NPRM Comment #4012) (fearing change may be
interpreted as the ``ability to substitute a different contact by
the same manufacturer (for example substituting Acuvue Oasys for
Acuvue Vita), rather than just a private label substitute''). \449\ Johnson & Johnson Vision Care, Inc. (NPRM Comment #4327);
see also American Optometric Association (NPRM Comment #3830)
(opposing Commission's proposal and finding the term ``private
label'' provides necessary clarity to ensure inappropriate
substitutions do not occur). \450\ Johnson & Johnson Vision Care, Inc. (NPRM Comment #4327). \451\ Johnson & Johnson Vision Care, Inc. also supported its
position that the clarification should be made in the preamble by
reference to the fact that there were not specific reports of
sellers encountering issues with the original Rule language. NPRM
Comment #4327.
--------------------------------------------------------------------------- Costco, in contrast, supported the Commission's proposed change,
because it would make clear that sellers can substitute their own
private label contact lenses for prescribed lenses that are identical
to lenses made by the same manufacturer and sold under the
manufacturer's brand.\452\ Although Costco believes that the existing
Rule allows it, when presented with a valid prescription for the
manufacturer's brand, to substitute Kirkland Signature lenses, it
believed that modifications to the language of Sec. 315.5(e) would
clarify and eliminate any doubt about the lawfulness of this practice.
Costco also opined that without such a change, the legality of such
substitution might be in question, and, as a result, some sellers,
particularly those without an established relationship with
prescribers, would likely be unwilling to invest in a private label
lens line.\453\ Consumers Union also supported the change, indicating
that it increases the choices available to consumers, including
potentially more affordable options, without in any way undermining
patient safety.\454\
--------------------------------------------------------------------------- \452\ Costco Wholesale Corporation (NPRM Comment #4281). \453\ Id. Costco also commented that bringing a private label
lens to market can significantly benefit consumers in terms of
introducing lower prices. NPRM Comment #4281. \454\ Consumers Union (NPRM Comment #3969).
--------------------------------------------------------------------------- The Commission did not intend for the removal of the words
``private label'' in the Rule to make substitution more widely
permissible beyond that of a seller being able to provide a private
label lens when the identical lens (made by the same manufacturer but
sold under a different label) is written on the prescription. However,
in order to allay concerns, the Commission has retained the term
``private label,'' but reordered the provision to clarify that
permissible substitution only involves private label contact lenses.
Thus, the Final Rule allows private label and brand name lenses, when
they are identical lenses made by the same manufacturer listed on the
prescription, to be substituted for each other.\455\
--------------------------------------------------------------------------- \455\ Section 315.5(f) of the Final Rule reads:
``Notwithstanding the preceding sentences, for private label contact
lenses, a seller may substitute for contact lenses specified on a
prescription identical contact lenses that the same company
manufactures and sells under different labels.'' The Commission
revised the provision to refer to the ``preceding sentences'' to
make it clear that the phrase beginning with ``[n]otwithstanding''
does not apply to anything other than Sec. 315.5(f).
---------------------------------------------------------------------------
2. The Commission Is Not Imposing Additional Requirements on
Prescriptions for Private Label Lenses As mentioned above, the Act and the Rule require prescriptions for
private label contact lenses to include ``the name of the manufacturer,
trade name of the private label brand, and if applicable, trade name of
equivalent brand name.'' \456\ LD Vision Group (LensDiscounters.com),
in response to the NPRM, provided the Commission with instances of
alleged rule violations involving private label prescriptions
improperly written or written without equivalents.\457\ It also
requested that the Commission reconsider LD Vision Group's previous
recommendations to: (1) Require prescribers to annotate private label
lens prescriptions with the brand-name equivalent and if the name-brand
equivalent is unavailable, the private-label prescription must be
medically necessary for that particular patient; (2) require
manufacturers of contact lenses to make brand information available to
all sellers, consumers, and the FTC; or (3) require manufacturers and
sellers to make brand equivalency information available and easily
accessible for private labels on their brand label packaging and
online.
--------------------------------------------------------------------------- \456\ 15 U.S.C. 7610; 16 CFR 315.2 (in definition of contact
lens prescription). \457\ This commenter also disagreed with what it stated was the
``Commission's diminishment of private label concerns.'' LD Vision
Group, Inc. (NPRM Comment #3958).
--------------------------------------------------------------------------- Although the Commission appreciates the additional information
provided by LD Vision Group, the information has not altered the fact,
as stated in the SNPRM, that the Act does 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.\458\ The Act also
does not expressly contemplate the imposition of disclosure
requirements on manufacturers. Therefore, the Commission is not
implementing the recommendations of LD Vision Group.
--------------------------------------------------------------------------- \458\ SNPRM, 81 FR 88551. In the SNPRM, the Commission also
referenced the initial rulemaking, where sellers recommended that
prescribers be required, when prescribing private label contact
lenses, to identify on the prescription the name of a brand that a
consumer could purchase from a seller other than the prescribing
office. 69 FR 40503. The Act does not limit, in any way, the brand
that a prescriber must select, and the current record does not have
sufficient evidence indicating that this is a problem. Id.
Therefore, LD Vision Group's proposal to limit prescribers from
prescribing private label brands without a brand-equivalent is not
adopted.
--------------------------------------------------------------------------- The Act and the Rule expressly require that, for private label
contact lens prescriptions, prescribers include ``trade name of
equivalent brand name.'' \459\ Prescribers violate the Rule if they
provide a script that omits this information because the script does
not meet the definition of a contact lens prescription. With that in
mind and given the additional information provided by LD Vision Group,
the Commission will consider whether enforcement action is appropriate.
--------------------------------------------------------------------------- \459\ 15 U.S.C. 7610, 16 CFR 315.2 (contact lens prescription
defined to include, in the case of a private label contact lens, the
name of the manufacturer, trade name of the private label brand,
and, if applicable, trade name of equivalent brand name).
---------------------------------------------------------------------------
VII. ``Directly or by Facsimile'' Language Includes Use of Online
Patient Portals to Present Prescriptions Section 315.5(a)(1) of the Rule provides that a seller may sell
contact lenses in accordance with a prescription that is presented to
the seller ``directly or by facsimile.'' In the NPRM, the Commission
initially determined that the provision ``directly or by facsimile''
includes the use of online patient portals by patients and prescribers
to present contact lens prescriptions to
[[Page 50702]]
sellers.\460\ The Commission noted that use of a patient portal
``necessarily involves `an exact copy of the prescription within the
scope of acceptable direct presentation mechanisms.' '' \461\ The
Commission observed in the NPRM that technology had evolved since the
Rule's implementation in 2004 and that patient portals offered several
potential benefits, including reducing: The chance of an inaccurate or
expired prescription being presented to a seller; the costs for
prescribers, patients, and sellers by making it easier and more
efficient for patients to share and present prescriptions; and the
number of verification requests to prescribers.\462\ The Commission
sought comments on whether the use of online portals complies with the
Rule and requested information about whether the Commission should
consider any other issues related to the presentation of prescriptions
to sellers.
--------------------------------------------------------------------------- \460\ NPRM, 81 FR at 88537-38. \461\ Id. at 88538. \462\ Id.
--------------------------------------------------------------------------- Although the Commission received many comments indicating that
patients are able to receive their prescriptions electronically,
including through patient portals, and interact with their prescribers
electronically,\463\ few comments addressed the use of portals to
present prescriptions directly to sellers. Commenters agreed that such
technology could offer benefits, including reducing the number of
requests for verification and additional copies, and giving patients
greater access to their prescriptions.\464\ However, it is unclear how
often, if at all, prescribers send prescriptions to sellers through a
portal. Use of portals to transmit prescriptions to sellers could face
barriers, including technology issues between the parties caused by
using different software and platforms, and privacy restrictions
preventing sellers from accessing patients' portal accounts.\465\
--------------------------------------------------------------------------- \463\ See, e.g., Eklund (WS Comment #502); Reed (WS Comment
#749); Gitchell (WS Comment #759); Andrews (WS Comment #1014);
Carvell (WS Comment #1021); Cecil (WS Comment #1892); Kuryan (WS
Comment #3472); Hopkins (NPRM Comment #184); Wilson (NPRM Comment
#1310); Grove (NPRM Comment #1702); MacDonald (NPRM Comment #2118);
Andrus (NPRM Comment #3345); American Academy of Ophthalmology (NPRM
Comment #3657) (``For practices that utilize electronic medical
record systems, patients can request a copy of their prescription
and [be] issued one electronically.''); Coalition for Contact Lens
Consumer Choice (SNPRM Comment #89). \464\ National Association of Optometrists and Opticians (NPRM
Comment #3851) (noting that the option to provide a prescription
through a portal should be available because technology will
continue to advance); 1-800 CONTACTS (NPRM Comment #3898); Costco
Wholesale Corp. (NPRM Comment #4281) (supporting the FTC's
determination regarding presentation of prescriptions directly or by
facsimile for the reasons cited in the NPRM); NPRM, 81 FR at 88538
(identifying the potential benefits of using a portal to present a
prescription to a seller). Other commenters have expressed the
potential benefits of portals or electronic health records
generally. See, e.g., Information Technology & Innovation Foundation
(SNPRM Comment #103); Opticians Association of Americas (WS Comment
#482); Marshall (WS Comment #518) (suggesting the benefit of
electronic medical records in allowing easier access to the
prescription); McCarty (WS Comment #1898); CooperVision, Inc. (WS
Comment #3077); Coalition for Contact Lens Consumer Choice (WS
Comment #3239) (stating that new technologies like electronic health
records have benefits for consumers). \465\ Hill (WS Comment #1361); McCarty (WS Comment #1898); Shum
(WS Comment #543) (stating that ``[t]he use of patient portals to
send Rx would be unreliable due to inconsistent EHR [(electronic
health records)] software and that some doctors do not have EHR'');
National Hispanic Medical Association (SNPRM Comment #146) (stating
that creating a portal to share prescription information could be a
burden on prescribers and patients); 1-800 CONTACTS (NPRM Comment
#3898) (stating that ``to the extent prescribers use portals to
provide sellers with prescriptions, their portal should have the
ability to send the prescription to the seller directly by email,
text, or facsimile, and a seller should not be required to develop
direct communication links to the portal''); CLR Panel V Tr., supra
note 191, at 19-20.
--------------------------------------------------------------------------- The Act and Rule clearly envision and support the use of electronic
means to provide prescriptions. Section 7601(a)(2) of the Act requires
prescribers to ``provide or verify the contact lens prescription by
electronic or other means'' to patients' agents.\466\ As discussed in
the NPRM, it would be inconsistent for the Rule to permit prescribers
to provide prescriptions electronically to patients, but not allow
prescribers to provide a prescription electronically to a seller.\467\
--------------------------------------------------------------------------- \466\ 15 U.S.C. 7601(a)(2); 16 CFR 315.3(a)(2). \467\ NPRM, 81 FR at 88538.
--------------------------------------------------------------------------- Use of electronic medical records has increased in the health field
generally,\468\ and many prescribers already use electronic methods to
communicate with patients, including through patient portals.\469\
Given the potential benefits, prescribers and patients should have the
option to present a prescription to sellers through a patient portal
when this method is available. Therefore, the Commission affirms its
initial determination that the ``directly or by facsimile'' language
includes the use of online patient portals by patients and prescribers
to present contact lens prescriptions to sellers.
--------------------------------------------------------------------------- \468\ One survey from 2017 found that 52% of individuals were
offered online access to their medical records by a health provider
or insurer, an increase from 42% in 2014. Of those patients who were
offered online access, more than half actually viewed their online
medical records at least once in the past year. U.S. Dep't of Health
& Human Servs., The Office of the National Coordinator for Health
Information Technology, ``Individuals' Use of Online Medical Records
& Technology for Health Needs'' 1-2 (2018). Furthermore, in 2013,
57% of prescriptions nationally were sent electronically from
physicians to pharmacies, with the rate in some states over 80%.
U.S. Dep't of Health & Human Servs., The Office of the National
Coordinator for Health Information Technology, ``E-Prescribing
Trends in the United States'' 8 (2014). \469\ American Optometric Association (SNPRM Comment #96)
(stating that approximately 47.5% of optometrists used electronic
health records with a patient portal in their practice); National
Association of Optometrists and Opticians (SNPRM Comment #129)
(``Practice management systems and electronic health records (EHRs)
with the capacity to allow patient portals, email, and text
communication are easily available at reasonable prices to
optometrists . . . .''); National Hispanic Medical Association
(SNPRM Comment #146); 1-800 CONTACTS (NPRM Comment #3898). But see
CLR Panel V Tr., supra note 191, at 17 (comment by a panelist that
only 8% of his office's patients used the portal).
---------------------------------------------------------------------------
VIII. Requests for an Additional Copy of a Prescription In the SNPRM, the Commission proposed requiring that prescribers
who receive requests for additional copies of prescriptions from
patients or their agents respond within forty business hours.\470\ The
Commission believed that the forty-business-hour requirement was
necessary to ensure that patients or their agents could receive
additional copies of their prescription in a timely manner while
recognizing that a shorter time period was unnecessary because patients
would have already received a copy of their prescription after the
contact lens fittings were completed and sellers could always submit a
verification request.\471\ Additionally, prescribers would be required
to note in the patient's file the name of the requester and the date
and time the prescription was provided. The Commission sought comment
on whether prescribers should be required to respond within a certain
time period, whether forty business hours was the appropriate time
period, and what records, if any, prescribers should be required to
keep to document the request and response.\472\
--------------------------------------------------------------------------- \470\ SNPRM, 84 FR at 24684. \471\ Id. \472\ Id.
---------------------------------------------------------------------------
A. Benefits of an Additional Copy and the Time Period To Respond to a
Request The AOA contends that Congress did not intend for sellers to be
given authorization to serve as the patient's agent.\473\ Rather, the
AOA ``assume[s] that Congress implemented this provision to account for
cases in which a family member or caregiver needed authorization to
obtain a patient's
[[Page 50703]]
prescription.'' \474\ As noted in the NPRM, the Commission relied on
the plain language of the Act and Rule to determine that sellers could
serve as agents for patients,\475\ and the AOA does not point to any
contrary evidence.\476\ Additionally, the AOA believes that no deadline
to respond to requests for additional copies is necessary because
prescribers take their responsibilities to their patients
seriously.\477\
--------------------------------------------------------------------------- \473\ American Optometric Association (SNPRM Comment #96). \474\ Id. \475\ NPRM, 81 FR at 88536. In addition to sellers, the SNPRM
noted that patients themselves could request an additional copy of
the prescription. Although a commenter requested that the Commission
modify the Rule to clarify that patients can request their own
additional copy (National Association of Optometrists and Opticians
(SNPRM Comment #129)), the Commission believes that the Rule's
language is sufficient and declines to make such change. SNPRM, 84
FR at 24684 n.259. \476\ American Optometric Association (SNPRM Comment #96). \477\ Id. The AOA also urged the Commission not to rely on 1-800
CONTACTS data indicating that only 46% of its requests for an
additional copy of a prescription received a response because 1-800
CONTACTS may not have the patients' consent to act as an agent.
Although the Commission considered the 1-800 CONTACTS data, the
Commission did not rely solely on this information when issuing its
proposed Rule. SNPRM, 84 FR at 24669.
--------------------------------------------------------------------------- Other commenters supported the Commission's proposal regarding
requests for additional copies.\478\ Commenters noted that a deadline
to respond would: (1) Make the process more predictable for patients
and sellers, especially when involving a prescriber who has not
responded to such requests in the past; \479\ (2) potentially reduce
the number of verification requests, which would benefit prescribers,
sellers, and patients; and (3) improve the accuracy of information
provided to sellers ensuring that patients receive the correct
lenses.\480\ In addition to anecdotal accounts of prescribers not
responding to requests for additional copies, 1-800 CONTACTS commented
that, in 2019 to date, it had received a response to approximately 52%
of its requests for an additional copy with 82% of the responses being
received within forty-eight hours of the request.\481\ This 2019 data
is similar to 1-800 CONTACTS' 2016 data, which showed that 46% of the
requests received a response and 90% of those responses were received
within two days.\482\ In response, the AOA questions 1-800 CONTACTS'
2016 data because patients, who gave consent through a prechecked box,
may not have intended for 1-800 CONTACTS to act as their agent in
requesting the prescription.\483\ The AOA posits that prescriber
concern over patients' consent ``may have impacted responses to [1-800
CONTACTS'] requests,'' but offers no evidence to support this
argument.\484\ Likewise, the AOA did not provide any data showing the
extent to which prescribers have responded to requests for additional
copies. Given the potential benefits and the aforementioned data, the
Commission does not believe it is sufficient to rely simply on the
expectation that all prescribers would fulfill their responsibilities
to their patients. Rather, the Commission believes that the Rule should
be amended to add a deadline to respond to a request for an additional
copy.
--------------------------------------------------------------------------- \478\ Citizen Outreach (SNPRM Comment #78); Lens.com (SNPRM
Comment #85); Coalition for Contact Lens Consumer Choice (SNPRM
Comment #89); Consumer Action (SNPRM Comment #101); Information
Technology and Innovation Foundation (SNPRM Comment #103); National
Association of Optometrists and Opticians (SNPRM Comment #129);
Consumer Reports (SNPRM Comment #133); 1-800 CONTACTS (SNPRM Comment
#135); American Academy of Ophthalmology (SNPRM Comment #136);
Attorneys General of 27 States (SNPRM Comment #139). \479\ Although not always the case, some sellers expressed
difficulties with obtaining responses from prescribers. See National
Association of Optometrists and Opticians (SNPRM Comment #129)
(stating that at least one NAOO member reported receiving timely
responses while other members found that it was ``difficult, if not
impossible, to get any form of a timely response''). \480\ Coalition for Contact Lens Consumer Choice (SNPRM Comment
#89); National Association of Optometrists and Opticians (SNPRM
Comment #129); Consumer Reports (SNPRM Comment #133); 1-800 CONTACTS
(SNPRM Comment #135); Attorneys General of 27 States (SNPRM Comment
#139); Contact Lens Association of Ophthalmologists (NPRM Comment
#4259). \481\ 1-800 CONTACTS (SNPRM Comment #135). \482\ 1-800 CONTACTS (NPRM Comment #3898). \483\ American Optometric Association (SNPRM Comment #96). \484\ Id.
--------------------------------------------------------------------------- Although some commenters agreed that the Commission's proposed
deadline of forty business hours was a reasonable length of time,\485\
other commenters urged the Commission to use a shorter period, such as
one business day \486\ or twenty-four business hours,\487\ because (1)
patients would want a quicker response, (2) the longer time period
could undercut a benefit of using a prescription--reducing the number
of verification requests, and (3) prescribers could be confused between
forty business hours for an additional copy request and eight business
hours for a verification request.\488\ Additionally, the work involved
for a prescriber's office to respond to a request would not increase
with a shorter deadline.\489\ Although patients would benefit from a
shorter response period, the Commission recognizes the additional
stress on prescribers of having less time to respond, even if the work
involved to complete a response remains the same. Because patients
should have already received a copy of their prescription after the
fitting,\490\ sellers can submit a verification request to complete the
sale more quickly,\491\ and prescribers have an obligation to respond
to a request for an additional copy, unlike a verification request, the
Commission declines to make any further changes and will adopt the
proposed forty-business-hour period.
--------------------------------------------------------------------------- \485\ Coalition for Contact Lens Consumer Choice (SNPRM Comment
#89); American Optometric Association (SNPRM Comment #96) (noting
that if a deadline were added, forty business hours would be
reasonable); Information Technology and Innovation Foundation (SNPRM
Comment #103); 1-800 CONTACTS (SNPRM Comment #135); American Academy
of Ophthalmology (SNPRM Comment #136). \486\ Consumer Reports (SNPRM Comment #133). \487\ National Association of Optometrists and Opticians (SNPRM
Comment #129) (supporting a shorter time limit, in part, because the
burden of complying could be lower due to portal, text, or email
use). \488\ National Association of Optometrists and Opticians (SNPRM
Comment #129); Consumer Reports (SNPRM Comment #133). \489\ Consumer Reports (SNPRM Comment #133). \490\ 16 CFR 315.3(a)(1). \491\ 16 CFR 315.5(a)(2).
---------------------------------------------------------------------------
B. Requirement To Maintain Records Finally, as to what records, if any, a prescriber should be
required to maintain regarding the request for an additional copy, the
AOA believes that sellers, not prescribers, should shoulder this burden
because sellers are ``leveraging the patient agent provision to obtain
patient prescriptions.'' \492\ Records of the request and the response
would allow the Commission to monitor compliance.\493\ However, the
Commission does not believe requiring the requestor to maintain such
information would be appropriate because the obligation under the Rule
to respond to prescription requests rests with prescribers and they
would be in the best position to maintain records.\494\ Importantly,
the Rule allows ``any person designated to act on behalf of the
patient[,]'' including the patients themselves, family members, or
caregivers, to request a copy of a prescription, not just sellers.\495\
A shift of the recordkeeping burden to any
[[Page 50704]]
designated agent making a request would not allow for effective
monitoring because the Commission might need to obtain records from a
wide variety of agents in order to determine whether a particular
prescriber is complying with the Rule. Thus, the Commission declines to
change the recordkeeping requirement.
--------------------------------------------------------------------------- \492\ American Optometric Association (SNPRM Comment #96). \493\ The proposed Rule would mandate that prescribers make
notations of the required information in their records, but would
not require that they keep specific documentation. SNPRM, 84 FR at
24698. However, prescribers could choose to keep documentation of
the request and response if they preferred. \494\ See also National Association of Optometrists and
Opticians (SNPRM Comment #129) (``We believe it will be straight-
forward and simple for the prescriber to keep a record of receiving
the request for a copy and noting how and when the prescriber
responded.''). \495\ SNPRM, 84 FR at 24684 n.259, 24698.
--------------------------------------------------------------------------- In conclusion, the Commission adopts the changes proposed in the
SNPRM to require that prescribers respond to requests for an additional
copy of a prescription within forty business hours and note in the
patient's record the name of the requestor and the date and time that
the prescription was provided in response.
IX. Excessive Quantity In the NPRM, the Commission declined to make any changes regarding
the number of lenses that a consumer can purchase with a
prescription.\496\ Several commenters had expressed concerns that
consumers were able to obtain more than a year's supply of contact
lenses, often by purchasing more than a year's worth at one time or by
refilling their prescription just before the expiration date.\497\
However, the Commission determined that there was insufficient evidence
on the record to support a limit on the maximum quantity of lenses that
consumers can purchase prior to the prescription's expiration.\498\
Although there was some evidence that patients purchased contact lenses
just before their prescriptions expired, this evidence did not show
that the quantity of lenses being purchased was excessive or that
consumers were skipping eye exams.\499\ Furthermore, the Commission
believed that a maximum quantity limit would be difficult to administer
and could have a more significant negative effect on consumers who,
instead of following the recommended replacement schedule, opt to wear
their lenses longer until they see a prescriber.\500\
--------------------------------------------------------------------------- \496\ NPRM, 81 FR at 88549. \497\ Id. at 88547-48. \498\ Id. at 88548-49. The Commission also declined to modify
the Rule to state that contact lens prescriptions are valid for an
unlimited quantity of lenses regardless of any prescriber-imposed
limitation. The Commission found no evidence that prescribers were
using quantity limits to undercut the prescription length and
recognized that some state laws or regulations mandated that
quantity information be included on a prescription, or that a
prescriber may choose to do so. NPRM, 81 FR at 88549-50. However,
prescribers cannot use quantity limits as a way to frustrate the
Rule's prescription expiration requirements. Id. at 88550. \499\ Id. \500\ Id.
--------------------------------------------------------------------------- In response to the NPRM, some commenters supported the Commission's
decision not to impose quantity limits \501\ while others expressed
concerns about the purchase of excessive quantities and advocated for
limits.\502\ The commenters who support quantity limits are concerned
that patients who purchase excessive quantities of lenses face
increased health risks because they do not see their prescriber as
often.\503\ Contrary to the Commission's position in the NPRM, they
believe that there is evidence in the record that consumers are
purchasing an excessive number of lenses close to the end of their
prescription and that a quantity limit can be implemented.\504\ These
commenters point to survey evidence by Johnson & Johnson Vision Care
showing that consumers, in response to reminders that their
prescriptions would be expiring soon, ordered more lenses.\505\
--------------------------------------------------------------------------- \501\ Coalition for Contact Lens Consumer Choice (NPRM Comment
#3718); Consumer Action (NPRM Comment #3721); 1-800 CONTACTS (NPRM
Comment #3898). \502\ See, e.g., Contact Lens Institute (SNPRM Comment #79);
Goodman (WS Comment 599); Hanen (WS Comment #712); Dillehay (WS
Comment #822); Rosenblatt (WS Comment #841); Hooven (WS Comment
#1366); Henry (WS Comment #2194); Robson (WS Comment #2210);
Wiechmann (WS Comment #2823); Health Alliance for Patient Safety (WS
Comment #3206); Alcon Laboratories, Inc. (WS Comment #3339);
Ellenbecker (WS Comment #3353); Jeun (NPRM Comment #1774); Daza
(NPRM Comment #2002); Silva (NPRM Comment #3072); CooperVision, Inc.
(NPRM Comment #3841); Coalition for Patient Vision Care Safety (NPRM
Comment #3883); see CLR Panel IV Tr., supra note 121, at 19
(statement of David Cockrell). \503\ Jeun (NPRM Comment #1774); Daza (NPRM Comment #2002);
CooperVision, Inc. (NPRM Comment #3841); Coalition for Patient
Vision Care Safety (NPRM Comment #3883). \504\ CooperVision, Inc. (NPRM Comment #3841); Coalition for
Patient Vision Care Safety (NPRM Comment #3883). \505\ CooperVision, Inc. (NPRM Comment #3841) (stating that
evidence of the high number of patients being contacted in the last
days of their prescription ``provides a powerful inference that
sales in many situations are excessive''); Coalition for Patient
Vision Care Safety (NPRM Comment #3883).
--------------------------------------------------------------------------- However, the concern is not whether consumers are purchasing lenses
near the end of their prescription, but whether they are purchasing
excessive quantities. As noted in the NPRM, the Johnson & Johnson
Vision Care survey did not ask about the quantity of lenses purchased
by consumers.\506\ The Commission had previously found that consumers
typically do not purchase a year's supply of lenses at one time.\507\
Additionally, 1-800 CONTACTS stated that it was aware of survey
evidence it believed showed that six months is the average size of an
order made during the last thirty days of a prescription, which is
similar to, based on 1-800 CONTACTS internal data, the average quantity
ordered throughout the duration of the prescription.\508\ Thus, the
Commission does not have sufficient basis to conclude, despite
anecdotal reports and alleged practices by some sellers, that consumers
are purchasing lenses in excessive quantities near the end of their
prescription.\509\ Neither does the Commission have sufficient evidence
showing that consumers are going to eye care providers less frequently
because they previously purchased large quantities of contact lenses.
In fact, evidence suggests that a majority of consumers are seeing
their eye care provider regularly. One survey found that contact lens
wearers have an eye exam every thirteen months on average while another
survey showed that about 56% of respondents received an eye exam every
twelve months or less, with an overall average of approximately sixteen
months.\510\ These surveys appear consistent with a prior survey by the
Coalition for Patient Vision Care Safety, which found that 87% of
contact lens wearers had an eye exam last year.\511\
--------------------------------------------------------------------------- \506\ NPRM, 81 FR at 88549-50; see also Johnson & Johnson Vision
Care, Inc. (RFC Comment #582) (asking consumers whether a seller
notified them that their prescription was expiring and whether they
have ever ordered lenses within a month of their prescription's
expiration). \507\ NPRM, 81 FR at 88549. \508\ 1-800 CONTACTS (NPRM Comment #3898) (stating that for a
monthly contact lens the standard package size is six months, which
is the minimum quantity available). \509\ NPRM, 81 FR at 88549. \510\ 1-800 CONTACTS (NPRM Comment #3898). \511\ NPRM, 81 FR at 88549 n.308.
--------------------------------------------------------------------------- Some commenters also believe that a quantity limitation would not
be difficult to implement when the seller has the prescription because
sales could be limited to the amount of lenses necessary for the
remaining period of the prescription or based on typical usage.\512\
However, it would be impractical for sellers to determine whether the
quantity of lenses being purchased is necessary or typical because such
amounts may not be the same for all consumers. Additionally, as noted
in the NPRM, there are legitimate reasons why a consumer may want to
purchase a supply of lenses that exceeds the remaining period of the
[[Page 50705]]
prescription, including having enough lenses until the next scheduled
appointment, having replacements for lost or torn lenses, or replacing
lenses more frequently.\513\ Additionally, quantity limitations could
encourage some consumers to stretch out their lens supply by wearing
them longer than recommended, which is a well-documented health issue
that outweighs the potential harm of patients purchasing a quantity of
lenses that exceeds what is strictly anticipated by the remaining
length of the prescription.\514\ Although it is possible that patients
could purchase large quantities of lenses by presenting their
prescription to multiple sellers, the Commission does not have evidence
about the extent of such practice.\515\ Finally, when verification is
used, a prescriber can determine whether the quantity ordered is
excessive, and, if it is, inform the seller within the eight-business-
hour period that the request is inaccurate and specify the appropriate
amount of lenses.\516\ In conclusion, the Commission declines to modify
the Rule to limit the quantity of lenses that consumers can purchase.
--------------------------------------------------------------------------- \512\ Contact Lens Institute (SNPRM Comment #79) (stating that
the ``health and safety of patients requires limits on the sale of
quantities of contact lenses beyond those reasonably required for
patient use during the remaining term of a prescription'' and urging
that a verification request for a prescription that is close to
expiration be treated as an alteration because it seeks to dispense
excessive quantities of lenses); Coalition for Patient Vision Care
Safety (NPRM Comment #3883) (stating that ``when the seller has the
prescription, no sale should exceed a supply of lenses necessary to
last the remaining period of the prescription''); CooperVision, Inc.
(NPRM Comment #3841). \513\ NPRM, 81 FR at 88549; 1-800 CONTACTS (NPRM Comment #3898). \514\ NPRM, 81 FR at 88549. See also 1-800 CONTACTS (NPRM
Comment #3898) (citing survey data showing that 65% of participants
tended to wear their last pair of contact lenses longer than when
they have a supply of lenses). \515\ NPRM, 81 FR at 88550. \516\ 16 CFR 315.5(d); Contact Lens Rule, 69 FR at 40501; NPRM,
81 FR at 88550 n.313.
---------------------------------------------------------------------------
X. Expiration of Contact Lens Prescriptions Section 315.6(a) of the Rule requires that a prescription expire 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.\517\ The Rule also provides that a prescription shall
not expire less than one year after the issue date of the prescription,
unless the prescriber specifies a shorter period that is ``based on the
medical judgment of the prescriber with respect to the ocular health of
the patient'' and documents the reasoning for the shorter expiration
period in the patient's medical record.\518\
--------------------------------------------------------------------------- \517\ 16 CFR 315.6(a)(1). \518\ 16 CFR 315.6(a)(2)-(3); 16 CFR 315.6(b)(1).
--------------------------------------------------------------------------- The NPRM addressed comments requesting that the Commission set a
longer minimum length for prescriptions, prohibit expirations on
certain prescriptions, or leave prescription length to the sole
discretion of the provider.\519\ However, because the Rule's provisions
closely track the Act, which sets a minimum expiration date ``to
prevent prescribers from selecting a short expiration date . . . that
unduly limits the ability of consumers to purchases contact lenses''
and because the Commission concluded that, in drafting the Act,
Congress intended to defer to state law except where such law
establishes a period of less than one year, the Commission stated that
the current framework is appropriate and declined to make changes.\520\
The NPRM also addressed prescriber reports of patients obtaining
contact lenses through sellers, especially online sellers, with expired
contact lens prescriptions.\521\ Commenters requested a Rule change or
greater enforcement of the Rule to deal with this problem.\522\
However, finding that the Rule sufficiently prohibited the use of
expired prescriptions, the Commission declines to amend the Rule.\523\
--------------------------------------------------------------------------- \519\ NPRM, 81 FR at 88546. \520\ Id.; see also 15 U.S.C. 7604. \521\ NPRM, 81 FR at 88546-47. \522\ Id. \523\ Id. at 88547.
---------------------------------------------------------------------------
A. Length of Contact Lens Prescriptions Following the NPRM's discussion of expiration length, the
Commission received additional comments that favored making
prescriptions valid for more than one year.\524\ Some commenters
advocated for such change because they believed that prescriptions
rarely change \525\ or that consumers would save money if they needed
to obtain exams less often.\526\ Other commenters expressed concern
that shorter prescription expirations may have the undesirable result
of encouraging consumers to wear contacts for longer than recommended
\527\ or that there should not be a standard minimum expiration in the
Rule due to variations in patient needs.\528\
--------------------------------------------------------------------------- \524\ Radcliffe (WS Comment #2); Williams (WS Comment #1036);
Yenovkian (WS Comment #1362); Yuen (NPRM Comment #1854); Susswein
(NPRM Comment #3759). \525\ Radcliffe (WS Comment #2); Williams (WS Comment #1036). \526\ Williams (WS Comment #1036); Yuen (NPRM Comment #1854). \527\ Berenguer (WS Comment #111). \528\ Moss (WS Comment #837).
--------------------------------------------------------------------------- However, some manufacturer and prescriber organizations favored
maintaining the Rule's current expiration provisions. Johnson & Johnson
Vision Care stated that the current Rule ``ensures that patients
continue to receive the vital professional oversight to decrease
avoidable risks and increases patient access to the latest technologies
to best meet their vision care needs.'' \529\ Likewise, the AOA and the
Contact Lens Institute supported the Commission maintaining the Rule's
current prescription length provisions.\530\
--------------------------------------------------------------------------- \529\ Johnson & Johnson Vision Care, Inc. (NPRM Comment #4327).
Peter Menziuso, President of JJVCI, also echoed this sentiment at
the workshop, stating that the company feels strongly about
maintaining the one-year expiration to assure patients are seeing
their prescriber regularly and prioritizing health. See CLR Panel IV
Tr., supra note 121, at 16. \530\ Contact Lens Institute (SNPRM Comment #79); American
Optometric Association (NPRM Comment #3830).
--------------------------------------------------------------------------- After reviewing the comments, the Commission again declines to
modify or remove the Rule's prescription length provisions. The current
Rule closely tracks the Act, which Congress mandated, and already
contains provisions that allow for prescriptions longer than one year,
dependent upon state law, and shorter than one year, when those are
appropriate based on the medical judgment of the prescriber, ensuring
flexibility.\531\ The Commission does not find the record adequately
supports lengthening the Rule's prescription expiration provisions.
Therefore, the Commission declines to alter the Rule's provisions
relating to prescription length.
--------------------------------------------------------------------------- \531\ 16 CFR 315.6(a)(2)-(3); 16 CFR 315.6(b)(1).
---------------------------------------------------------------------------
B. Sales Using Expired Contact Lens Prescriptions After the NPRM, commenters again raised the issue of sellers
selling contact lenses past the prescription expiration dates,\532\ and
some argued that additional regulation is needed.\533\ The Rule already
makes clear that expired prescriptions are invalid and prohibits
[[Page 50706]]
sales with such prescriptions.\534\ If a consumer presents the seller
with an expired prescription, the seller cannot use it as the basis for
the sale. Not only is the seller unable to base a sale on that expired
prescription, but as the Commission clarified in the NPRM, a seller may
not use an expired prescription as the basis for a verification
request.\535\ If, however, a seller is presented with a prescription
that lacks an expiration date,\536\ and that seller does not have
knowledge as to whether the prescription is expired, the seller must
verify the prescription with the prescriber prior to dispensing lenses.
In this instance, the seller may rely on the prescriber to inform the
seller if the prescription is expired.\537\
--------------------------------------------------------------------------- \532\ See, e.g., Hanian (SNPRM Comment #27); Pirozzolo (SNPRM
Comment #33); Wilkes (SNPRM Comment #86); AOA (SNPRM Comment #96);
Parikh (SNPRM Comment #152); Fuller (WS Comment #531); McBride (WS
Comment #630); Swindell (WS Comment #682); Hamilton (WS Comment
#781); Caywood (WS Comment #788); Matus (WS Comment #1534); Malaski
(WS Comment #3160); DiGirolamo (NPRM Comment #23); Endry (NPRM
Comment #29); Ross (NPRM Comment #48); Hanen-Smith (NPRM Comment
#154); Weisz (NPRM Comment #963); Helwig (NPRM Comment #2349);
Simpson (NPRM Comment #2896); Holle (NPRM Comment #3214); Gordon
(NPRM Comment #3544); Reinstein (NPRM Comment #3560); Sheffer (NPRM
Comment #3577). \533\ Kepley (SNPRM Comment #76); Radford (NPRM Comment #59);
Rodriguez (NPRM Comment #3896) (``I was disappointed to learn that
the FTC will not, under its existing authority, seek to more-fully
address the many unscrupulous business practices of online contact
lens sellers that have been putting the health and safety of
patients at risk for more than a decade. Expired contact lens
prescriptions are regularly processed and filled by these online
business.''); Huang (NPRM Comment #2203); Avila (NPRM Comment #52);
Hanen-Smith (NPRM Comment #154); Letter from Senator Heidi Heitkamp
to Acting Chairwoman Maureen Ohlhausen (Jan. 5, 2018); Letter from
Congressman Jeff Denham et al. to Chairman Joseph Simons (July 27,
2018). \534\ 16 CFR 315.5(d). \535\ NPRM, 81 FR at 88546-47. \536\ 16 CFR 315.2. \537\ NPRM, 81 FR at 88547.
--------------------------------------------------------------------------- CooperVision requested that the Commission require that sellers,
when not in possession of an unexpired prescription, ask consumers if
their prescriptions have expired.\538\ In the NPRM, the Commission
addressed a similar request by AOA to require sellers to include the
expiration and issue dates, both required elements of a prescription,
in verification requests.\539\ According to the AOA, this requirement
would incentivize sellers to make sure patients know their prescription
expiration date. However, as explained in the NPRM, the seller would
not necessarily have the expiration or issue dates, and neither would
the patient.\540\ A better source for this information is the
prescriber, who has the ability to invalidate a prescription request
because it is expired.\541\ For this reason, the Commission will not
implement CooperVision's proposal. Additionally, a number of prescriber
organizations expressed concerns that consumers are able to buy lenses
on expired prescriptions because of passive verification.\542\ Further,
to lessen the chances of the sale of lenses after the expiration of a
prescription, some commenters requested that the Commission require
that prescriptions be presented at the time of the sale of lenses.\543\
As stated in Section V, Congress mandated passive verification, and
requiring prescription presentation would be inconsistent with
Congress's intent. The Final Rule also includes several changes to
automated verification calls that will improve passive verification by
allowing prescribers to better identify requests based on expired
prescriptions.\544\
--------------------------------------------------------------------------- \538\ CooperVision, Inc. (SNPRM Comment #130). \539\ NPRM, 81 FR at 88547 (citing AOA Comment #644). \540\ NPRM, 81 FR at 88547. \541\ As explained in the Alteration section, Section VI, supra,
if a seller wishes to avail itself of the exception to alteration,
it may use an expired prescription as an indication of manufacturer
or brand if the minimum criteria discussed in that Section are met,
and the seller obtains additional information, from the consumer or
the prescriber, that the consumer has a current prescription for
that brand. In so doing, the seller obtains a basis for the
verification request other than the expired prescription. \542\ Contact Lens Institute (SNPRM Comment #79) (``Indeed, CLI
remains concerned about the contribution of passive verification via
robocalls to filling expired or invalid prescriptions . . .'');
American Society of Cataract and Refractive Surgery (SNPRM Comment
#127) (``Significant concerns with patient safety, as the current
eight-hour validation window allows inaccurate, falsified, and
expired contact lens prescriptions to be filled. Subsequently,
patients' ocular health is put at risk because of a restricted
validation period.''); American Society of Cataract and Refractive
Surgery (NPRM Comment #3820) (``Many of our members practice in solo
or small practices that often do not have the resources to respond
to verification requests within the eight-hour time frame. This rule
allows a seller to fill a prescription that is inaccurate, expired,
or falsified simply because the prescriber has been unable to
respond within eight hours. As a result, patients suffer serious eye
injuries by wearing ill-fitted contacts.''); Massachusetts Society
of Eye Physicians and Surgeons (NPRM Comment #4270). \543\ Sanders (SNPRM Comment #61); Wisniewski (NPRM Comment
#1769); Hanian (NPRM Comment #153). \544\ See Section III, supra.
--------------------------------------------------------------------------- Finally, commenters again requested that the Commission bring
enforcement actions against sellers that sell lenses after the
expiration of the prescription.\545\ As stated in the NPRM, if the
Commission receives credible evidence that sellers are selling contact
lenses when they have actual knowledge that the prescriptions are
expired (either because they were presented with a copy of an expired
prescription or received a response from a prescriber within the time
frame specified in the Rule telling the seller that the prescription is
expired), the Commission will take appropriate steps to investigate the
allegations.\546\
--------------------------------------------------------------------------- \545\ Cooper Vision, Inc. (SNPRM Comment #130); Stout (WS
Comment #450); Stolicker (NPRM Comment #10); Osetek (NPRM Comment
#22); Bass (NPRM Comment #55); Coalition for Patient Vision Care
Safety (NPRM Comment #3883); Letter from Congressman David Roe to
Chairman Joseph Simons (Nov. 29, 2018). \546\ NPRM, 81 FR at 88547.
---------------------------------------------------------------------------
XI. Paperwork Reduction Act The existing Rule contains recordkeeping and disclosure
requirements that constitute ``collection[s] of information'' 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.\547\ On May 28, 2019, the Commission
issued a SNPRM proposing amendments that would contain new information
collection requirements subject to OMB review and approval.
Specifically, the SNPRM estimated an additional recordkeeping burden
for prescribers resulting from the proposed Rule modifications to
597,917 hours (85,417 hours regarding signatures + 512,500 hours
regarding their retention) and the associated estimated annual labor
cost burden of $13,244,727.\548\ On the same date, the Commission also
submitted a request to OMB seeking approval for the new information
collections associated with the proposed rulemaking. On September 20,
2019, the OMB directed the Commission to examine public comments
relating to the proposed rulemaking and describe any public comments
received regarding the collection, as well as why the Commission did or
did not incorporate the commenter's recommendation.\549\ Below, the
Commission describes and discusses the amendments to the Final Rule,
the public comments received relating to the collection of information
burden associated with the SNPRM, and the Commission's ultimate
determination of the burden generated by the final amendments.
--------------------------------------------------------------------------- \547\ On October 2, 2019, the Commission requested permission
from OMB to continue these pre-existing information collections,
which were estimated to be 2,104,050 annual hours of burden (which
were derived by adding 1,045,650 disclosure hours for contact lens
prescribers to 1,058,400 recordkeeping hours for contact lens
sellers). See 84 FR 51162 (Sept. 27, 2019); Agency Information
Collection Activities; Submission for OMB. On December 9, 2019, OMB
approved the Rule's existing information collection requirements
through December 31, 2022. OMB Control No. 3804-0127. See 84 FR
51162 (Sept. 27, 2019); Agency Information Collection Activities;
Submission for OMB Review; Comment Request. \548\ See 84 FR at 24693-94 (May 28, 2019); Supplemental notice
of proposed rulemaking; request for public comment. \549\ OMB Control No. 3804-0127, ICR Reference No. 201910-3084-
001, Notice of Office of Management and Budget Action (Sept. 10,
2019).
--------------------------------------------------------------------------- The Commission has made a number of modifications to the Rule that
contain recordkeeping requirements that are collections of information
as defined by 5 CFR 1320.3(c). First, the Rule has been modified to
require that prescribers either: (A) Obtain from patients, and maintain
for a period of not less than three years, a signed confirmation of
prescription release on a separate stand-alone document; (B) obtain
from patients, and maintain for a period of not less than three years,
a patient's signature on a confirmation of prescription release
included on a copy of a patient's prescription; (C) obtain from
patients, and maintain for a period of not less than three years, a
patient's signature on a confirmation of
[[Page 50707]]
prescription release included on a copy of a patient's contact lens
fitting sales receipt; or (D) provide each patient with a copy of the
prescription via online portal, electronic mail, or text message, and
for three years retain evidence that such prescription was sent,
received, or, if provided via an online-patient portal, made
accessible, downloadable, and printable by the patient.\550\ For
prescribers who choose to offer an electronic method of prescription
delivery, the Final Rule requires that such prescribers identify the
specific method or methods to be used, and maintain records or evidence
of affirmative consent by patients to such digital delivery for three
years.\551\ For instances where a consumer refuses to sign the
confirmation or accept digital delivery of their prescription, the
Final Rule directs the prescriber to note the refusal and preserve this
record as evidence of compliance.\552\ None of these new requirements,
however, would apply to prescribers who do not have a direct or
indirect financial interest in the sale of contact lenses.\553\
--------------------------------------------------------------------------- \550\ 16 CFR 315.3(c)(1). \551\ 16 CFR 315.2. \552\ 16 CFR 315.3(c)(1)(iii). \553\ 16 CFR 315.3(c)(3).
--------------------------------------------------------------------------- Additional modifications to the Rule that constitute collections of
information as defined by 5 CFR 1320.3(c) require that sellers who use
calls containing automated verification messages: (1) Record the entire
call; (2) commence the call by identifying it as a request for
prescription verification; (3) provide the information required by
Sec. 315.5(b) in a slow and deliberate manner and at a reasonably
understandable volume; and (4) give the prescriber the option to repeat
the information.\554\ The call recordings must be preserved for at
least three years.\555\
--------------------------------------------------------------------------- \554\ 16 CFR 315.5(d). \555\ 16 CFR 315.5(h)(4).
--------------------------------------------------------------------------- The Commission hereby provides PRA burden estimates, analysis, and
discussion for the requirements to collect patient signatures as
confirmation of prescription release and as consent to electronic
prescription delivery; and the requirement to record automated
verification messages; and associated recordkeeping obligations.
A. Confirmation of Prescription Release and Affirmative Consent to
Digital Delivery of a Prescription
1. SNPRM Burden Estimate for the Confirmation of Prescription Release In its SNPRM, the Commission put forth estimates for the additional
burden on individual prescribers' offices to generate and present to
patients the confirmations of prescription release, and to collect and
maintain the confirmations of prescription release for a period of not
less than three years.\556\ As set out in the PRA section's
introductory paragraph above, the Commission previously calculated this
burden to be 597,917 hours (85,417 hours for prescribers to collect
patient signatures and 512,500 hours for prescribers' office staff to
store them).\557\ Based on average hourly wage rates, the Commission
calculated the aggregate labor cost burden (totaling prescribers and
prescribers' office staff) at $13,244,727.\558\ The Commission noted,
however, that arguably, the overall burden of the Rule--including
verification costs previously approved by the Office of Management and
Budget \559\--could be lower (or not increase) given the proposed
modification's potential offsetting effects of more patients being in
possession of their prescriptions and consequently fewer
verifications.\560\
--------------------------------------------------------------------------- \556\ SNPRM, 84 FR at 24692. \557\ Id. at 24693. \558\ Id. at 24694. This estimate was based on a mean hourly
wage of $57.26 for optometrists and $16.30 for office clerks.
Economic News Release, U.S. Dep't of Labor, Bureau of Labor
Statistics, Table 1. National employment and wage data from the
Occupational Employment Statistics survey by occupation, May 2017. \559\ See note 549, supra. \560\ SNPRM, 84 FR at 24693-94.
--------------------------------------------------------------------------- The Commission requested comment on the accuracy of the FTC's
burden estimates, including whether the methodology and assumptions
used are valid (such as whether prescribers or office staff are more
likely to collect patient signatures and retain associated
recordkeeping), and a quantification of the reduction in verifications
resulting from the confirmation of prescription proposal.\561\
--------------------------------------------------------------------------- \561\ Id.
---------------------------------------------------------------------------
2. Comments Regarding the SNPRM Estimate for the Confirmation of
Prescription Release Requirement In response to the Commission's SNPRM proposal, several commenters
reiterated that obtaining and storing the Confirmations of Prescription
Release would create ``onerous'' administrative and financial burdens,
but most commenters did not supply financial estimates for this
burden.\562\ The AOA, which had previously estimated the cost of the
NPRM's signed-acknowledgment proposal to be as high as $18,795 per
optometrist,\563\ did not submit a new burden estimate for the
Confirmation of Prescription Release proposal, but did opine that the
increased flexibility of the new proposal would not reduce the overall
burden on prescribers.\564\ One commenter estimated that it would cost
his practice $10,000 per year in ``paperwork, storage, and time spent
by secretaries handling paperwork,'' but did not provide details about
his practice (the number of patients and prescribers, for instance) or
how the estimate was derived, and what the cost amounted to on a per-
patient or per-prescription basis.\565\ Another commenter, Dr. Thomas
Steinemann, wrote, ``I dispute the FTC contention that each
documentation will only take `one minute.' Additional documentation can
actually take several minutes when there are discrepancies in
verification.'' \566\ Dr. Steinemann commented that according to his
office manager, the ``additional steps of verification and
documentation'' would add 10 minutes of administrative time per
patient.\567\ The comment, however, does not articulate how the
Confirmation of Prescription Release requirement can create
discrepancies in verification, or what ``additional steps of
verification'' Dr. Steinemann or his office manager are referring to.
The Confirmation of Prescription Release requirement does not directly
impact the requirement that prescribers verify prescriptions upon
request, other than to potentially make such requests less common if
more patients have possession of their prescriptions and can present
them to sellers when ordering.
--------------------------------------------------------------------------- \562\ See Section II.C.7, supra. \563\ American Optometric Association (NPRM Comment #3830). As
noted in note 247, supra, the Commission explained in the SNPRM that
it could not accord this estimate significant weight because it was
based not on the cost of the proposed Signed Acknowledgment but on
the overall cost of government regulations (including those already
in place), and because the survey had numerous methodological
limitations. SNPRM, 84 FR at 24677. \564\ American Optometric Association (SNPRM Comment #96). A few
SNPRM commenters reiterated the AOA's $18,000 estimate (which the
Commission previously determined it could not rely on, for reasons
explained in the SNPRM), 84 FR at 24677, but did not provide
additional information or empirical support for this figure. Koerber
(SNPRM Comment #110); American Society of Cataract and Refractive
Surgery (SNPRM Comment #127). \565\ Pierce (SNPRM Comment #17). \566\ Steinemann (SNPRM Comment #65); Steinemann (SNPRM Comment
#138). \567\ Id.
--------------------------------------------------------------------------- In contrast to those critical of the burden and the Commission's
SNPRM PRA analysis, other commenters contended that the burden of the
new requirement would be minimal or offset by a reduced burden in other
respects of the Rule.\568\ One commenter, the ITIF, asserted that
evidence that the new
[[Page 50708]]
requirement would increase prescriber costs ``appears to be
significantly overstated,'' and noted that storing confirmation
signatures in paper takes up ``very little room and cost,'' and, if
stored electronically, storage costs are ``essentially zero.'' \569\
The ITIF also stated allowing prescribers to deliver prescriptions
digitally would reduce the ``already small'' burden on prescribers of
the confirmation of release requirement, and at the same time reduce
the number of verification calls from third party lens sellers, thus
further reducing the overall burden on both sellers and
prescribers.\570\
--------------------------------------------------------------------------- \568\ See Section II.C.7, supra. \569\ Information Technology & Innovation Foundation (SNPRM
Comment #103). \570\ Id. See also National Association of Optometrists and
Opticians (SNPRM Comment #129) (stating that with more practitioners
moving to practice management systems and electronic health records,
digital delivery of contact lens prescriptions is a ``very
feasible'' option for many prescribers, which will further reduce
the burden of the confirmation requirement).
--------------------------------------------------------------------------- Another commenter, the National Taxpayers Union (``NTU''), felt the
SNPRM burden-estimates were ``plausible,'' and noted that the FTC's
estimates were based on underlying assumptions that may be overly
cautious, and thus lead to overcounting.\571\ In particular, the NTU
noted that the Commission, in calculating the SNPRM's PRA burden: (1)
Assumed that only optometrists would obtain patient signatures, when,
in fact, support staff--who are paid less per hour--are permitted to do
so; (2) provided sample confirmation language so prescribers wouldn't
have to formulate their own; (3) assumed that every provider would
spend a minute per confirmation even though states already impose
recordkeeping requirements, and electronic storage might take seconds;
and (4) did not account for potentially offsetting reductions in burden
hours for eye care providers due to reduced time and effort spent
responding to verification requests (since more patients would have
possession of their prescriptions and be able to present them to third-
party contact lens sellers).\572\
--------------------------------------------------------------------------- \571\ National Taxpayers Union (SNPRM Comment #149). \572\ Id. See also National Association of Optometrists and
Opticians (SNPRM Comment #129) (stating that with more patients in
possession of their prescriptions, there would be fewer orders
relying on the verification process).
--------------------------------------------------------------------------- Likewise, 1-800 CONTACTS submitted a new analysis from Stanford
Health Research Professor Laurence Baker that called the Commission's
burden analysis ``conservative,'' and estimated that a reduction in
verification requests by 13-15% would be sufficient to offset all of
the costs of the confirmation requirement.\573\
--------------------------------------------------------------------------- \573\ 1-800 CONTACTS (SNPRM Comment #135).
--------------------------------------------------------------------------- None of the SNPRM commenters offered detailed suggestions for
reducing the burden resulting from the Confirmation of Prescription
Release proposal, other than to suggest that the Commission withdraw
its proposal completely or choose a substantially different
alternative, such as signage or public education.\574\ For reasons
discussed in Section II.C.6., supra, the Commission does not believe
such alternatives would effectively serve the purpose of the Rule.
--------------------------------------------------------------------------- \574\ See Section II.C.6, supra.
---------------------------------------------------------------------------
3. Estimated Additional Burden Hours for the Confirmation of
Prescription Release Requirement Commission staff estimates the PRA burden of the Confirmation of
Prescription Release requirement based on comments received and its
long-standing knowledge and experience with the eye care industry.\575\
Staff continues to believe there will be an additional burden on
individual prescribers' offices to satisfy the confirmations of
prescription release requirements, but that this burden will be
relatively small in the context of the overall market for contact
lenses and examinations.\576\
--------------------------------------------------------------------------- \575\ See Section I.B., supra, discussing the Commission's three
decades of experience with the optical goods industry. \576\ One survey estimated that the U.S. contact lens market
totaled approximately $5,012,800,000 (not counting examination
revenue) in 2017. ``Vision Markets See Continued Growth in 2017,
VisionWatch Says,'' Vision Monday, March 20, 2018, http://www.visionmonday.com/business/research-and-stats/article/vision-markets-see-continued-growth-in-2017-visionwatch-says/. See also
note 609 and accompanying text, infra.
--------------------------------------------------------------------------- The number of contact lens wearers in the United States is
currently estimated to be approximately 45 million.\577\ Therefore,
assuming an annual contact lens exam for each contact lens wearer, the
Confirmation of Prescription Release requirement would require that 45
million people either read and sign a Confirmation of Prescription
Release or agree to receive their prescription electronically.
--------------------------------------------------------------------------- \577\ Centers for Disease Control, Healthy Contact Lens Wear and
Care, Fast Facts, https://www.cdc.gov/contactlenses/fast-facts.html.
This is an updated figure that represents an increase of four
million wearers since the NPRM and SNPRM estimates were prepared.
--------------------------------------------------------------------------- Nothing in the comments to the SNPRM alters the Commission's belief
that generating and presenting the Confirmation of Prescription Release
will not require significant time or effort. The comments describing
the burden as crippling and onerous do not contain empirical facts or
data regarding the amount of time and cost of the Commission's
proposal, and some estimates appear overstated. The Commission continues to believe that creating the Confirmation
of Prescription Release should not be difficult to implement since the
requirement is flexible in that it allows any one of several different
modalities and delivery methods, including adding the confirmation to
existing documentation that prescribers routinely provide (sales
receipts) or are already required to provide (prescriptions) to
patients. The requirement is also flexible in that it does not
prescribe other details such as the precise content or language of the
patient confirmation, but merely requires that, if provided to the
patient pursuant to options specified in Sec. 315.3(c)(1)(i)(A), (B),
and (C), the confirmation from the patient must be in writing. At the
same time, it is not required that prescribers spend time formulating
their own content for the confirmation, since the Rule provides draft
language that prescribers are free to use, should they so desire.
Furthermore, the confirmation requirement is flexible enough to cover
situations where a contact lens fitting is completed remotely, since a
prescriber can readily satisfy the confirmation and prescription-
release requirements by various methods, including email, text, or
uploading the prescription to a patient portal, so long as the patient
consents to such delivery. The four options for a prescriber to confirm a prescription release
to a patient are set out in Sec. 315.3(c)(1)(i)(A), (B), (C), and (D).
The requirement in options (A), (B), and (C) to provide the patient
with a Confirmation of Prescription Release statement are not
disclosures constituting an information collection under the PRA
because the FTC, in Sec. 315.3(c)(1)(ii), has supplied the prescriber
with draft language the prescriber can use to satisfy this
requirement.\578\ As noted above, however, the requirement in (A), (B),
and (C) to collect a patient's signature on the Confirmation of
Prescription Release and preserve it constitutes an information
collection as defined by OMB regulations that implement the PRA.
Nonetheless, the Commission believes it will require minimal time for a
patient to read the confirmation and provide a signature. The
Commission estimated in the SNPRM that it would
[[Page 50709]]
take patients ten seconds to read the one-sentence Confirmation of
Prescription Release and provide a signature,\579\ and the Commission
believes that ten seconds remains an appropriate estimate.
--------------------------------------------------------------------------- \578\ ``The public disclosure of information originally supplied
by the Federal government to the recipient for the purpose of
disclosure to the public is not included within'' the definition of
``collection of information.'' 5 CFR 1320.3(c)(2). \579\ SNPRM, 84 FR at 24693. This estimate was based on
responses to a consumer survey regarding how long it would take
consumers to read the Signed Acknowledgment, and a prior PRA
estimate for consumers to complete a similar signed acknowledgment.
--------------------------------------------------------------------------- The fourth option, Sec. 315.3(c)(1)(i)(D), does not, in and of
itself, constitute an information collection under the PRA, since no
new information that would not otherwise be provided under the Rule is
provided to or requested from the patient.\580\ Excluding that option
from consideration, and assuming the remaining three options are
exercised with equal frequency, 75% of approximately 45 million annual
prescription releases will entail reading and signing a confirmation
statement. Thus, assuming ten seconds for each release, prescribers and
their office staff would devote 93,750 hours, cumulatively (75% x 45
million prescriptions yearly x 10 seconds each) to obtaining patient
signatures as confirmations of prescription release.\581\
--------------------------------------------------------------------------- \580\ In order to utilize Sec. 315.3(c)(1)(i)(D), however, a
prescriber must obtain and maintain records or evidence of
affirmative consent by patients to electronic delivery of their
prescriptions. 16 CFR 315.2. The burden to do so is included in the
recordkeeping burden calculation of this PRA Section. \581\ Section 315.3(c)(1)(iii) also requires that in the event
that a patient declines to sign a confirmation requested under
paragraphs (c)(1)(i)(A), (B), or (C), the prescriber must note the
patient's refusal on the document and sign it. However, the
Commission has no reason to believe that such notation should take
any longer than for the patient to read and sign the document, so
the Commission will maintain its calculation as if all confirmations
requested under (c)(1)(i)(A), (B), or (C) require the same amount of
time.
--------------------------------------------------------------------------- Maintaining those signed confirmations for a period of not less
than three years should also not impose substantial new burdens on
individual prescribers and office staff. The majority of states already
require that optometrists keep records of eye examinations for at least
three years,\582\ and thus many prescribers who opt to include the
confirmation of prescription release on the prescription itself would
be preserving that document, regardless. Similarly, most prescribers
already retain customer sales receipts for financial accounting and
recordkeeping purposes, and thus prescribers who opt to include the
confirmation of prescription release on the sales receipt also could be
retaining that document, regardless. Moreover, storing a one-page
document per patient per year should not require more than a few
seconds, and an inconsequential, or de minimis, amount of record space.
Some prescribers might also present the Confirmation of Prescription
Release in electronic form, enabling patients to sign a computer screen
or tablet directly and have their confirmation immediately stored as an
electronic document. For other prescribers, the new recordkeeping
requirement would likely require that office staff either preserve the
confirmation in paper format, or electronically scan the signed
confirmation and save it as an electronic document. For prescribers who
preserve the confirmation electronically by scanning it, Commission
staff estimates that saving such a document would consume approximately
one minute of staff time. Commission staff does not possess detailed
information on the percentage of prescribers' offices that currently
use and maintain paper forms, electronic forms, or that scan paper
files and maintain them electronically. Thus, for purposes of this PRA
analysis, Commission staff will assume that all prescriber offices who
opt for Sec. 315.3(c)(1)(i) (A), (B), or (C) require a full minute per
confirmation for recordkeeping arising from the modifications.
Excluding from PRA consideration the fourth option, Sec.
315.3(c)(1)(i)(D), as there is no signature to obtain or retain, and
assuming that prescribers elect the other options three-fourths or 75%
of the time, the recordkeeping burden for all prescribers to scan and
save such confirmations would amount to 562,500 hours (75% x 45 million
prescriptions yearly x one minute for scanning and storing) per year.
--------------------------------------------------------------------------- \582\ 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).
--------------------------------------------------------------------------- As noted previously, the fourth option for satisfying the
Confirmation of Prescription Release requirement does not necessitate
that prescribers obtain or maintain a record of the patient's signature
confirming receipt of her prescription. However, as explained in Sec.
315.2, under the Rule's now-modified definition of Provide to the
patient a copy, in order to avail themselves of the fourth option,
prescribers must obtain and maintain records or evidence of the
patients' affirmative consent to electronic delivery for three years.
In order to remain as cautious as possible in estimating the burden,
the Commission will use the assumption that consumers sign such
consents for electronic delivery pursuant to Sec. 315.3(c)(1)(i)(D)
for one quarter of the 45 million prescriptions released per year,\583\
and that this task would take the same amount of time as to obtain and
maintain a signature of the patient's Confirmation of Prescription
Release. Thus, the Commission will allot 218,750 hours \584\ for the
time required for prescribers to obtain affirmative consents and
maintain records of same.
--------------------------------------------------------------------------- \583\ 11,250,000 (45 million prescriptions x 25%). \584\ 31,250 hours (11,250,000 prescriptions yearly x 10
seconds) for obtaining the signature plus 187,500 hours (11,250,000
affirmative consents x one minute) for storing such records.
--------------------------------------------------------------------------- Therefore, the estimated incremental PRA recordkeeping burden for
prescribers and their staff resulting from the Confirmation of
Prescription Release modifications to the Rule amounts to 906,250 total
hours ((93,750 and 31,250 hours, respectively, to obtain signatures
confirming release and consenting to electronic delivery) plus (562,500
and 218,750 hours, respectively, to maintain such records for three
years)). As some commenters noted, the overall burden of the Rule--
particularly verification costs previously approved by the Office of
Management and Budget \585\--could lessen (or not increase by as much
as the incremental burden from the proposed Rule modifications), given
potentially offsetting effects presented by the Commission's Rule
modifications.\586\ With more patients in possession of their
prescriptions (due to increased prescription release), and a greater
ability to present them to sellers (due to the modification requiring
sellers to provide a method for patients to present prescriptions)
fewer time-consuming verifications would be necessary.\587\
--------------------------------------------------------------------------- \585\ See note 549, supra. \586\ See Information Technology & Innovation Foundation (SNPRM
Comment #103); 1-800 CONTACTS (SNPRM Comment #135); National
Taxpayers Union (SNPRM Comment #149). \587\ Id.
--------------------------------------------------------------------------- Based on new projections from 1-800 CONTACTS \588\ and a previous
analysis by the Commission,\589\ a decrease of between 13%-23% in
verifications could be sufficient to offset the entire cost of the
Confirmation of Prescription Release requirement. In the SNPRM,
however, the Commission noted that these estimates rely on a number of
assumptions, not all of which are confirmed as accurate.\590\
Furthermore,
[[Page 50710]]
neither 1-800 CONTACTS, nor any other commenter, provided empirical
data or projections as to how much the number of verifications will
decline due to the Rule modifications. The Commission continues to lack
this data, and thus cannot predict whether the verification decrease--
should it occur--would be sufficient to offset any or all of the
burden. Therefore, the Commission will not make an adjustment for
offsetting effects and benefits at this time.
--------------------------------------------------------------------------- \588\ 1-800 CONTACTS (SNPRM Comment #135) (estimating that a
reduction of 13%-15% in verifications would offset the estimated
costs of the proposal). \589\ SNPRM, 84 FR at 24693-94. \590\ Id. at 24678. The calculation also does not take into
account any of the benefit to consumers from having their
prescriptions and being able to choose from among competing sellers;
the savings consumers might achieve by purchasing lower-priced
lenses; the improvements to health and safety due to a reduction in
errors associated with invalid prescriptions currently verified
through passive verification; and the Commission's ability to assess
and verify compliance with the Rule.
--------------------------------------------------------------------------- For this specific reason, and the various cautious assumptions
described above, the Commission's estimate of 906,250 total hours for
prescribers and their staff resulting from the Confirmation of
Prescription Release requirement may well overstate the burden of the
modification. Furthermore, the actual burden should be even lower
because none of the Confirmation of Prescription Release requirements
apply to prescribers who do not have a direct or indirect financial
interest in the sale of contact lenses. The Commission requested but
did not receive comment on the percentage of prescribers who might be
exempt, and does not currently possess sufficient information to
determine what percentage of prescribers do not have a financial
interest in the sale of contact lenses. The Commission thus has not
reduced the estimated PRA burden accordingly at this time.
4. Estimated Total Labor Cost Burden for the Confirmation of
Prescription Release Modification Commission staff derives labor costs by applying appropriate
hourly-cost figures to the burden hours described above. The task to
obtain patient confirmations and consent to electronic delivery could
theoretically be performed by medical professionals (e.g.,
optometrists, ophthalmologists) or their support staff (e.g.,
dispensing opticians, medical technicians, office clerks). In the
SNPRM, the Commission requested comment as to whether prescribers or
office staff are more likely to collect patient signatures and retain
associated recordkeeping, but did not receive significant guidance on
this. Therefore, staff will continue to assume that optometrists will
perform the task of collecting patient signatures, and staff will
perform the labor pertaining to printing, scanning, and storing of
documents, even though this may lead to some overcounting of the
burden. According to the Bureau of Labor Statistics, salaried optometrists
earn an average wage of $57.68 per hour, and general office clerks earn
an average wage of $16.92 per hour.\591\ Using the aforementioned
estimate of 125,000 total prescriber labor hours for obtaining patient
signatures, the resultant aggregate labor costs to obtain patient
signatures is $7,210,000 (125,000 hours x $57.68).
--------------------------------------------------------------------------- \591\ Press Release, Bureau of Labor Statistics, United States
Department of Labor, Occupational Employment Statistics--May 2018,
https://www.bls.gov/news.release/ocwage.t01.htm.
--------------------------------------------------------------------------- As previously noted, Commission staff assumes that office clerks
will typically perform the labor pertaining to the printing, scanning
and storing of prescription release confirmations. Applying a mean
hourly wage for office clerks of $16.92 per hour to the aforementioned
estimate of 781,250 hours, cumulative labor costs for those tasks would
total $13,218,750. Therefore, combining the aggregate labor costs for both prescribers
and office staff to obtain signed patient confirmations and consent to
electronic delivery and preserve the associated records, the Commission
estimates the total labor burden of the Confirmation of Prescription
Release modification to be $20,428,750. This represents an increase
from the SNPRM's estimated burden for the Confirmation of Prescription
Release proposal due to a relatively large increase in the number of
contact lens wearers now estimated by the Centers for Disease
Control,\592\ increases in the estimated wages of optometrists and
office staff by the Bureau of Labor Statistics,\593\ and the additional
Rule modification requiring prescribers to collect and preserve
patients' affirmative consent to electronic delivery of their
prescriptions.
--------------------------------------------------------------------------- \592\ Centers for Disease Control, Healthy Contact Lens Wear and
Care, Fast Facts, https://www.cdc.gov/contactlenses/fast-facts.html. \593\ Press Release, Bureau of Labor Statistics, United States
Department of Labor, Occupational Employment Statistics--May 2018,
https://www.bls.gov/news.release/ocwage.t01.htm.
---------------------------------------------------------------------------
5. Capital and Other Non-Labor Costs for the Confirmation of
Prescription Release Requirement The proposed recordkeeping requirements detailed above regarding
prescribers impose negligible capital or other non-labor costs, as
prescribers likely have already the necessary equipment and supplies
(e.g., prescription pads, patients' medical charts, scanning devices,
recordkeeping storage) to perform those requirements.
B. Recording of Automated Telephone Messages As noted above, the Commission has further modified the Rule to
require that sellers who use automated verification messages record the
calls and preserve the recordings for three years. In the SNPRM, the
Commission staff did not put forth a specific burden estimate for this
requirement, but rather sought comments to help inform such estimated
burden, to the extent applicable.\594\
--------------------------------------------------------------------------- \594\ SNPRM, 84 FR at 24694.
--------------------------------------------------------------------------- The Commission received a few comments stating that the requirement
presented a burden for sellers.\595\ 1-800 CONTACTS, for instance,
commented that the requirement to store the recorded calls would impose
a costly new burden while providing relatively few associated
benefits.\596\ Consumer Reports essentially reiterated this view.\597\
None of the commenters, however, provided data or cost figures that
would help inform the Commission's estimated burden.
--------------------------------------------------------------------------- \595\ See Sections III.B., C. and D, supra. \596\ 1-800 CONTACTS (SNPRM Comment #135). \597\ Consumer Reports (SNPRM Comment #133).
--------------------------------------------------------------------------- The Commission does not believe that requiring sellers who use
automated telephone messages for verification to record the calls and
preserve the recordings will create a substantial burden. The
requirement will not require additional labor time for sellers, since
the verification calls will be for the same duration that they are now
(the length of time required to submit the information required for
verification under Sec. 315.5 (b)). However, the new requirement will
likely require capital and other non-labor costs to record the calls
and store them electronically. But sellers who utilize automated
telephone messages for verification are already availing themselves of
sophisticated communication technology, and thus should not find it
daunting to implement technology to record such calls. Meanwhile the
growth of digital recording technology, and the capital investment
required for recording equipment and record storage, is rapidly
declining and has been for some time.\598\ A phone service provider
used by at least one online contact lens seller, for example,
advertises that it charges a quarter of one cent ($.0025) for each
minute recorded, plus a storage fee of $.0005-per-month for each minute
of
[[Page 50711]]
recorded storage over 10,000.\599\ In other words, assuming each
verification call requires three minutes of recording, the first 3333
verification calls recorded and stored would cost $25 (three-fourths of
one cent per call),\600\ and each additional verification call would
cost approximately six cents apiece to record and store for three
years.\601\ Other phone service providers surveyed advertise call-
recording options such as $4.99 per gigabyte (about 5000 minutes) of
recorded calls (about 4/10th of a cent per verification call),\602\ and
1000 minutes of call recording for $14.95 (approximately 4.5 cents per
verification call).\603\ Some services also advertise unlimited call-
recording plans ranging anywhere from $20-70 a month, depending on how
many lines, and how much storage is required.\604\ The costs of these
services would vary depending on what other options are selected, how
long storage is required, and the size of the order, among other
things, and the Commission does not vouch for the sufficiency of any of
these services. Rather, the Commission mentions these advertised
promotions to demonstrate that the cost of recording calls does not
appear to be burdensome. Moreover, the Commission believes, as stated
in Section III, supra, that any incremental costs to sellers for
recording calls is outweighed by the benefit to consumers and
prescribers from curtailing invalid verification calls. For purposes of
calculating the PRA burden, however, the Commission will estimate that
each three-minute verification call costs five cents to record.
--------------------------------------------------------------------------- \598\ See Final Rule, Telemarketing Sales Rule, 68 FR 4622 (Jan.
29, 2003) (discussing the cost for recording calls, and determining
it was not a significant obstacle for telemarketers). \599\ Twilio Support, https://support.twilio.com/hc/en-us/articles/223132527-How-much-does-it-cost-to-record-a-call-. \600\ (10,000 minutes x $.0025) / 3333 three-minute calls =
$.0075 per call. \601\ Id. For each additional three-minute verification call, it
would cost three-quarters of a cent to record and .15 of a cent per
month to store the recording (5.4 cents for 36 months), for a total
of 6.15 cents per call. \602\ https://getvoip.com/blog/2017/11/16/call-recording/; see
also https://jive.com/features/call-recording (estimating that one
gigabyte typically stores about 5,000 minutes of recorded calls). \603\ https://www.phone.com/pricing-all/. \604\ https://www.avoxi.com/blog/best-call-recording-service/.
--------------------------------------------------------------------------- According to recent survey data, approximately 36% of contact lens
purchases are from a source other than the prescriber.\605\ Assuming
that each of the 45 million contact lens wearers in the U.S. makes one
purchase per year, this would mean that approximately 16,200,000
contact lens purchases (45 million x 36%) are made annually from
sellers other than the prescriber. Based on prior discussions with
industry, approximately 73% of sales by non-prescriber sellers require
verification, meaning that approximately 11,826,000 purchases would
require verification calls, faxes, or emails (16,200,000 x 73%). The
Commission does not possess information as to the percentage of
verifications completed by telephone versus fax or email. Thus for
purposes of this analysis, the Commission will assume that all
verifications are performed via telephone. Furthermore, the Commission
does not have information as to the percentage of telephone
verifications that are automated as opposed to live calls, and thus
will assume that all telephone verifications are automated calls and
subject to the new call-recording requirement.
--------------------------------------------------------------------------- \605\ Jason J. Nichols & Deborah Fisher, ``2018 Annual Report,''
Contact Lens Spectrum, Jan. 1, 2019, https://www.clspectrum.com/issues/2019/january-2019; VisionWatch, Contact Lenses, September
2019.
--------------------------------------------------------------------------- Based on the aforementioned assumptions, the Commission estimates
that the requirement to record automated telephone messages will
require recording 11,826,000 calls \606\ at an annual cost to third-
party sellers, in the aggregate, of $591,300 (11,826,000 x $.05).
--------------------------------------------------------------------------- \606\ In some instances, sellers may have to call more than once
to verify an order. In those instances, however, only the recording
of the successful verification would need be preserved.
---------------------------------------------------------------------------
C. Total Burden for the Modifications to the Rule Combining the marginal cost of the Rule modifications for both
sellers and prescribers, the Commission estimates that the amendments
will impose an additional burden of $21,020,050 ($20,428,750 for
prescribers + $591,300 for third-party sellers). Adding these estimated
costs to the OMB's already approved existing cost burden ($84,548,448)
results in a total PRA burden from the Rule of $105,568,498. While not
insubstantial, this represents just two percent of the overall
$5,012,800,000 contact lens market in the United States.\607\ Moreover,
as noted previously, the estimated burden is calculated using several
cautious assumptions that may overstate the actual cost; in all
likelihood, the actual burden will be significantly less.
--------------------------------------------------------------------------- \607\ ``Vision Markets See Continued Growth in 2017, VisionWatch
Says,'' Vision Monday, March 20, 2018, http://www.visionmonday.com/business/research-and-stats/article/vision-markets-see-continued-growth-in-2017-visionwatch-says/. See also, Steve Kodey, US Optical
Market Eyewear Overview, 4, https://www.ftc.gov/sites/default/files/filefield_paths/steve_kodey_ppt_presentation.pdf.
---------------------------------------------------------------------------
XII. Regulatory Flexibility Act The Regulatory Flexibility Act (``RFA'') \608\ requires that the
Commission provide an Initial Regulatory Flexibility Analysis
(``IRFA'') with a Proposed Rule, and a Final Regulatory Flexibility
Analysis (``FRFA'') with the Final Rule, unless the Commission
certifies that the Rule will not have a significant economic impact on
a substantial number of small entities.\609\ The purpose of the
regulatory flexibility analysis is to ensure that the agency considers
the impact on small entities and examines regulatory alternatives that
could achieve the regulatory purpose while minimizing burdens on small
entities.
--------------------------------------------------------------------------- \608\ 5 U.S.C. 601-612. \609\ 5 U.S.C. 603-605.
--------------------------------------------------------------------------- Although the Commission believed that the amendments it proposed
would not have a significant economic impact on small entities, it
included an IRFA in the SNPRM and solicited public comment.\610\ In
this section, the Commission discusses the SNPRM comments that
addressed the IRFA,\611\ as appropriate, below. The Final Rule is
similar to the rule proposed in the SNPRM. The Commission continues to
believe that the amendments it is adopting will not have a significant
economic impact upon small entities, but has nonetheless deemed it
appropriate as a matter of discretion to provide this FRFA.
--------------------------------------------------------------------------- \610\ SNPRM, 84 FR at 24694. The Commission's NPRM also included
an IRFA. NPRM, 81 FR at 88588. \611\ Unlike many other commenters who addressed the IRFA
indirectly, the AOA commented on the RFA by name stating its belief
that the Commission ``has not fully considered the regulatory burden
under which physicians are already operating'' and cited to the
Office of Advocacy of the U.S. Small Business Administration's FY
2018 Report on the Regulatory Flexibility Act. According to the AOA,
that report stated that ``[s]mall businesses have told advocacy
stories that exemplify how federal regulations drain small
businesses' resources, energy, and in some cases even their desire
to stay in business.'' The AOA indicated that it ``has heard the
same concerns voiced by doctors of optometry who after years of
service in patient care find that the regulatory framework is so
intrusive to the doctor patient relationship, [sic] that some
consider leaving the profession.'' SNPRM Comment #96.
---------------------------------------------------------------------------
A. Need for and Objectives of the Rule Amendments The Commission's Final Rule incorporates changes affecting
prescribers and sellers. These changes were, in large part, previously
addressed in the Commission's NPRM and SNPRM, including in the
Regulatory Flexibility Act sections. As explained in the earlier IRFAs,
the need for and objective of these changes is to clarify
[[Page 50712]]
and update the Rule in accordance with marketplace practices.
1. Amendments Affecting Prescribers The following changes affect prescribers, many of whom are small
businesses: (1) Should the prescriber so choose, allow for electronic
delivery of prescriptions as a means for automatic prescription release
when agreed to by the patient (and in such cases, prescribers must
retain evidence for not less than three years that the prescription was
sent, received, or made accessible, downloadable, and printable). The
prescriber must identify to the patient the specific method of
electronic delivery and obtain the patient's consent to that method,
and maintain the evidence of consent for a period of not less than
three years; (2) Request the patient sign a confirmation of receipt of
a contact lens prescription (and if a patient declines to sign, must
note the patient's refusal on the document and sign it); \612\ and (3)
Respond to authorized seller requests for copies of a prescription
within forty business hours, and require the prescriber to make a
notation in the patient's record when responding to such requests.
--------------------------------------------------------------------------- \612\ This requirement does not apply to prescribers who do not
have a direct or indirect financial interest in the sale of contact
lenses.
--------------------------------------------------------------------------- As explained in detail in this Final Rule notice, the Commission
has determined that a Confirmation of Prescription Release is necessary
for several reasons, including: (1) Multiple consumer surveys
consistently show prescriber non-compliance with, and lack of consumer
awareness of, the Rule's prescription-release requirement; (2) numerous
personal accounts of prescribers' failure to release prescriptions; (3)
the persistently high number of verifications, many of which would be
unnecessary were consumers in possession of their prescriptions; (4)
the regulatory structure of the contact lens market, which requires a
consumer to obtain lenses pursuant to a prescription while permitting
prescribers to sell what they prescribe, thus creating an incentive for
prescribers to withhold prescriptions; and (5) the lack of credible
empirical evidence rebutting or contradicting the evidence that
prescribers are not automatically releasing prescriptions, and that
consumers are not fully aware of their rights.\613\
--------------------------------------------------------------------------- \613\ See Section II, supra.
--------------------------------------------------------------------------- The Commission further determined that allowing prescribers to
satisfy the automatic prescription release requirement by using an
online patient portal or other electronic method in lieu of a paper
copy, when the patient gives verifiable affirmative consent, offered
benefits for sellers, prescribers, and patients. Patients would be able
to access their prescriptions and have electronic copies to send to
sellers. With the prescription, a seller would no longer need to submit
a verification request, which would also benefit prescribers by
reducing the volume of requests.\614\
--------------------------------------------------------------------------- \614\ For a more detailed analysis of the reasons the Commission
allowed prescribers to satisfy the automatic release requirement
electronically in the Final Rule, see Section II.C.5., supra.
--------------------------------------------------------------------------- The Commission is also instituting a forty-business-hour
requirement for prescribers to provide additional copies of
prescriptions upon request from a patient's agent to ensure that
patients or their agents can receive additional copies of their
prescription in a timely manner.\615\ Additionally, prescribers would
be required to note in the patient's file the name of the requester and
the date and time the prescription was provided so that the Commission
is able to determine, if necessary, whether a prescriber has complied
with the Rule.
--------------------------------------------------------------------------- \615\ See Section VIII, supra.
---------------------------------------------------------------------------
2. Amendments Affecting Sellers The amendments affecting sellers require them: (1) When using
automated telephone messages to verify prescriptions, to record the
entire call (and maintain such recordings for a period of not less than
three years), commence the call by identifying it as a request for
prescription verification made in accordance with the Contact Lens
Rule, deliver the required information in a slow and deliberate manner
and at a reasonably understandable volume, and make the required
information repeatable at the prescriber's option; (2) to provide
consumers with a method that allows consumers to submit their
prescriptions to sellers; and (3) to verify only the contact lens brand
or manufacturer that appears on the consumer's prescription, unless the
consumer has provided an unprescribed contact lens manufacturer or
brand in response to a specific request from the seller. The Commission implemented the additional requirements for
automated verification calls to relieve the burden on prescribers and
reduce potential health risks to patients from incomplete or
incomprehensible automated telephone messages. Specifically, the
Commission noted that prescribers must be able to understand automated
messages so they can, if necessary, respond to sellers to prevent
improper sales. The Commission imposed the amendments in response to
concerns about the quality of automated telephone messages, and
instated the recording requirement because without such a record, the
Commission cannot reliably assess whether a call was compliant, and
further, whether the seller has a pattern of placing non-compliant
calls (and unlawfully selling after such calls). The Commission also imposed a requirement for sellers to accept
prescription presentation to reduce the number of verifications, reduce
errors associated with incorrect verification attempts, and make it
more difficult for ill-intentioned sellers to abuse the passive
verification framework and take advantage of consumers who might not
realize that the seller intends to verify a different lens than the one
written on their prescription. The Commission modified the definition of alteration, and included
an exception for sellers that verify only the contact lens brand or
manufacturer that consumers indicate is on their prescriptions in order
to address the emergence of several businesses that rely exclusively,
or almost exclusively, on passive verification as a means to substitute
their own brand of contact lenses for those originally prescribed by
the patient's prescriber. The Commission continues to receive reports
about the proliferation of passive verification abuses. The
implementation of the alteration definition, including the exception,
should serve as an effective deterrent against sellers that try to game
the verification system to sell non-prescribed contact lenses.\616\
--------------------------------------------------------------------------- \616\ The reasons for this Final Rule amendment are more fully
discussed in Section VI, supra.
---------------------------------------------------------------------------
B. Significant Issues Raised by Public Comments in Response to the
IRFA, Including Any Comments Filed by the Chief Counsel for Advocacy of
the Small Business Administration, and the Agency's Response, Including
Any Changes Made in the Final Rule Amendments The Commission did not receive any comments from the Small Business
Administration on this Rule Review. The Commission did receive comments
from various interested parties in response to the SNPRM, and it
discusses them below.
1. Amendments Affecting Prescribers As discussed in detail in this notice, the Commission, in the
SNPRM, determined that the Rule needs to contain some form of patient
confirmation requirement, but the Commission made changes to its prior
[[Page 50713]]
signed-acknowledgment proposal (put forth in the NPRM) in an effort to
reduce the burden associated with, and address other criticisms
surrounding, the proposal. These changes included: (1) Adding an option
for prescribers to satisfy the confirmation requirement by releasing
the prescription electronically under certain conditions; (2) excluding
from the requirement eye care prescribers who have no direct or
indirect financial interest in the sale of contact lenses; and (3)
allowing prescribers to craft their own wording of the signed
confirmation, while providing sample confirmation language that
prescribers can use at their discretion.\617\ In response to the SNPRM
proposal, the Commission received a number of comments, mostly from
prescribers, criticizing, and detailing the burden of, and other issues
associated with complying with, the Commission's Confirmation of
Prescription Release requirement.\618\
--------------------------------------------------------------------------- \617\ In the Final Rule, for instances where a patient refuses
to sign the confirmation, the Commission directs the prescriber to
note the refusal and preserve this record as evidence of compliance. \618\ See Section II, supra.
--------------------------------------------------------------------------- Other SNPRM commenters provided new views or concerns about the
NPRM's proposal to require that prescribers respond to requests from
patients or their agent for an additional copy of a prescription within
forty business hours. Some commenters felt that the Commission should
not impose a time period for prescribers to respond to requests from
patients or their agents for an additional copy of a prescription.
Other commenters recommended that the Commission require prescribers to
respond to such requests within a shorter period of time. The
Commission has determined that a defined time period is necessary, and
that its SNPRM proposal of forty business hours should be sufficient to
ensure prescribers comply within a reasonable amount of time, while at
the same time limit the additional burden on them to do so.\619\
--------------------------------------------------------------------------- \619\ These commenters' concerns and the Commission's response
to such concerns are addressed more fully in Section VIII, supra.
---------------------------------------------------------------------------
2. Amendments Affecting Sellers In response to the SNPRM's proposal to require that each
verification call: commence by identifying it as a request for
prescription verification made in accordance with the Contact Lens
Rule; deliver the required information in a slow and deliberate manner
and at a reasonably understandable volume; and make the required
information repeatable at the prescriber's option, the Commission did
not receive any comments suggesting that this resulted in a burden.
Some commenters did raise objections, however, to the Commission's
recording requirement, as discussed in detail in Section III.C., supra.
For the reasons discussed in that Section and reiterated in A.2. of
this Section, the Commission determined to retain the recording
requirement. The Commission did not receive any comments opposing the SNPRM's
proposal requiring that sellers provide a method of, and a disclosure
of the method of, prescription presentation. The Commission did receive
a comment, however, suggesting that the Commission require that the
method to present prescriptions be in close proximity to the option to
provide the parameters of the contact lens for verification. Although
the Commission did not impose that requirement, it took that comment
into account in determining that, to maximize the potential benefit
from the amendment, the seller must provide and disclose the method for
the patient to present the seller with a copy of the patient's
prescription prior to requesting a prescriber's contact lens
prescription. In addition, the Commission, in response to comments
addressing the issue, provided more guidance on the methods that
sellers need to use (i.e., the method by which the order is taken or
email, text or file upload). The Commission also received comments on the SNPRM's proposed
modification defining alteration, and providing an exception to
alteration for sellers that verify only the brand or manufacturer that
consumers indicate is on their prescription. Some commenters felt the
modification was unnecessary, and that other Rule changes were adequate
to curb the practices of substitution to non-prescribed brands through
use of the verification system. As addressed in Section VI.B., supra,
the Commission has determined that there are benefits to retaining this
modification. In response to comments, however, the Commission provided
additional guidance on the acceptable methods for obtaining brand and
manufacturer information.
C. Description and Estimate of the Number of Small Entities to Which
the Amendments Will Apply or Explanation Why No Estimate Is Available Prescribers of contact lenses are affected by the amendments
concerning the option for electronic delivery of prescriptions as a
means for automatic prescription release, Confirmation of Prescription
Release, and the imposition of a forty-business-hour time frame for
responding to authorized requests for additional copies of
prescriptions. There are approximately 43,000 optometrists and 16,700
ophthalmologists in the United States,\620\ though not all optometrists
and ophthalmologists would be affected by the amendments since some do
not prescribe contact lenses. Some prescribers who prescribe contact
lenses also would not be affected by the Confirmation of Prescription
Release requirement if they do not have a direct or indirect interest
in the sale of contact lenses. Of the contact lens prescribers who are
affected by the modifications, the Commission--based on its knowledge
of the eye-care industry--believes that many fall into the category of
small entities (e.g., offices of optometrists with less than $7.5
million in average annual receipts).\621\ Determining a precise
estimate of the number of small entities covered by the Rule's
prescription-release requirements is not readily feasible, however,
because most prescribers' offices are private entities that do not
release the underlying revenue information necessary to make this
determination.\622\ The Commission sought comment in its SNPRM
regarding the estimated number or nature of such small business
entities, if any, for which the proposed amendments would have a
significant impact, and did not receive commenter guidance in return.
--------------------------------------------------------------------------- \620\ See note 269, supra. \621\ 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. \622\ 5 U.S.C. 601(6).
--------------------------------------------------------------------------- Non-prescriber sellers of contact lenses are affected by the
amendments concerning the additional requirements for using an
automated telephone verification message, requirements to accept
prescription presentation, and requirements to verify only the contact
lens brand or manufacturer that consumers indicate is on their
prescriptions.\623\ Based on its knowledge of the industry, staff
believes that the number of these entities that likely qualify as small
businesses (less than $22 million in average annual receipts) is not
likely to be substantial.\624\
--------------------------------------------------------------------------- \623\ Most prescribers who sell lenses do so after fitting the
patient with the prescribed lens, and thus do not rely on
prescription verification. The amendments affecting sellers pertain
to verification or prescription presentation and do not pertain to
these sales. As a result, the Commission does not consider
prescribers in its estimated burden for the proposals affecting
sellers. \624\ See U.S. Small Business Admin., ``Table of Small Business
Size Standards Matched to North American Industry Classification
System Codes'' (Aug. 19, 2019), https://www.ecfr.gov/cgi-bin/text-idx?SID=b919ec8f32159d9edaaa36a7eaf6b695amp;mc=true&node=pt13.1.121&r
gn=div5#se13.1.121_1201.
---------------------------------------------------------------------------
[[Page 50714]]
D. Description of the Projected Reporting, Recordkeeping and Other
Compliance Requirements of the Amendments, Including an Estimate of the
Classes of Small Entities That Will Be Subject to the Requirement and
the Type of Professional Skills Necessary for Preparation of the Report
or Record
1. Amendments Affecting Prescribers The Confirmation of Prescription Release amendment requires that
prescribers with a direct or indirect interest in the sale of contact
lenses request that patients sign, and maintain for a period of not
less than three years, either (A) a statement confirming receipt of the
contact lens prescription; (B) a prescriber-retained copy of a contact
lens prescription that contains a statement confirming receipt of the
contact lens prescription; or (C) a prescriber-retained copy of the
receipt for the examination that contains a statement confirming
receipt of the contact lens prescription. As an alternative to (A), (B), and (C), under certain conditions,
prescribers can provide a contact lens prescription digitally. In order
to avail themselves of this option, prescribers must maintain, for a
period of not less than three years, evidence that the prescriptions
were sent, received, or made accessible, downloadable and printable. In
addition, the prescriber must identify to the patient the specific
method or methods of electronic delivery to be used, such as text
message, electronic mail, or an online patient portal, obtain the
patient's verifiable affirmative consent to receive a digital copy
through the identified method or methods, and maintain records or
evidence of a patient's affirmative consent for a period of not less
than three years. The small entities potentially covered by these amendments will
include all such entities subject to the Rule. The professional skills
necessary for compliance with the Rule as modified will include office
and administrative support supervisors to create the language and
format of the confirmation, and clerical personnel to collect
signatures from patients and maintain records, or in the case of
digital prescriptions, retain evidence that the prescription was sent,
received, or made accessible, downloadable and printable and retain
evidence of a patient's affirmative consent. Compliance may include
some minimal training time as well. The Commission has provided
language that prescribers can use for the Confirmation of Prescription
Release which, should a prescriber elect to use such language, negates
the burden of formulating appropriate language. The Commission believes
the overall burden imposed on small businesses by these requirements is
relatively small, for the reasons described previously in Section
II.C.7. of this notice. That section also addresses in detail the
comments received, which discuss the burden from this amendment. The amendment relating to providing a designated agent with an
additional copy of a prescription requires that the prescriber respond
within forty business hours of receipt of the request, and note in the
patient's record the name of the requester and the date and time that
the prescription was provided to the requester. The professional skills
necessary for compliance with this amendment will include office and
administrative support staff to respond to the request within forty
business hours. Previously, office and administrative support staff
were already required to respond to such requests, just not within a
specific time frame. The forty-business-hour time period, in and of
itself, should not impose a significant new burden. The office and
administrative support staff will also need to make the required
notations in the patient's records. As noted, the required notation
would be limited to the name of the requester and the date and time the
prescription was provided to the requester. Although the Rule does not
require that prescribers retain the notations, the Commission expects
prescribers would make and retain such notations in the ordinary course
of their business and thus believes the proposal would not create much,
if any, additional burden.
2. Amendments Affecting Sellers To the extent, if any, that non-prescriber sellers are small
entities, the amendments relating to changes in verifications made
through automated telephone messages require sellers to record the
entire call, commence the call by identifying it as a request for
prescription verification made in accordance with the Rule, deliver the
information in a slow and deliberate manner and at a reasonably
understandable volume, and make the information repeatable at the
prescriber's option. Sellers must retain the complete call recording of
such automated telephone messages for at least three years. The Commission believes that most small sellers who are covered by
the Rule, if any, are unlikely to have undergone or to undergo the
expense associated with creating and maintaining an automated telephone
system for verification requests.\625\ Instead, the Commission believes
that small sellers typically comply with the Rule by receiving copies
of prescriptions from patients, or making verification requests to
prescribers via fax, email, or telephone calls using ``live'' agents.
If a small seller already has an automated system for verification, the
Commission does not believe the costs to accommodate the changes would
be more than minimal, if any. For a seller who was following the FTC's
prior guidance that automated messages be delivered at a volume and
cadence that a reasonable person can understand,\626\ it already
complies with the new proposal that all such messages be at a
``reasonably understandable volume'' and delivered in a ``slow and
deliberate manner.'' Similarly, if not already in compliance, a seller
might need to modify its model verification recording to identify at
the start that a call is being made in accordance with the Contact Lens
Rule and to make the required information repeatable at the
prescriber's option.
--------------------------------------------------------------------------- \625\ 1-800 CONTACTS also believes this to be the case. See 1-
800 CONTACTS (SNPRM Comment #135) (stating that the number of
sellers that use this particular technology is likely limited). \626\ Prior guidance from the FTC directed sellers to deliver
verification messages at a volume and cadence that a reasonable
person can understand. See note 301, supra.
--------------------------------------------------------------------------- The Commission also has little reason to believe that the new
requirement that sellers who use automated messages record such calls
and retain them for no less than three years creates a substantial
burden for small sellers. The Commission's SNPRM invited comment on the
frequency with which small sellers use automated telephone messages for
verification and the costs associated with the proposals pertaining to
these messages, including whether existing verification systems include
the capability to record and the capacity for storage, and the costs
associated with recording the calls and maintaining the recordings for
no less than three years. The Commission received little guidance in
response. 1-800 CONTACTS, a large contact lens seller, stated the
proposal to record and store these calls imposes a ``costly'' burden,
but did not detail the costs associated with recording and maintaining
the calls. The Commission's own research surrounding such costs for
recording phone calls does not support this contention.\627\ And as
noted above, the
[[Page 50715]]
number of sellers that employ this technology is limited, and the
Commission does not believe that small sellers use or are likely to use
automated messages for verification calls.
--------------------------------------------------------------------------- \627\ See PRA discussion of the cost of recording calls, Section
XI.B., supra.
--------------------------------------------------------------------------- The new requirement that sellers provide a method, and a clear and
prominent disclosure of the method, for the consumer to present the
seller with a copy of the patient's prescription also does not impose a
large burden on small sellers. A small seller would need to update its
website or other consumer interface to inform consumers about the
ability to provide the seller with a prescription, or alternatively, if
an order occurs via telephone or in person, to verbally inform the
consumer about the ability to provide the seller with a prescription.
The professional skill or time necessary for this task would include
personnel with the skills required to update the website or other
consumer interface, and the time it takes to make the updates, or if
the information is relayed over the phone or in person, the additional
time for an employee or agent of the seller to inform a consumer that
he or she is able to provide a prescription, and of the method by which
a consumer can do so. These proposals may also require training time
for staff. The seller would also need to provide a mechanism for a
consumer to provide the prescription to the seller. Because a small
seller almost certainly already has the capacity to accept
prescriptions via an existing electronic system or email account, the
Commission believes there is little additional burden of complying with
this part of the proposal. The small seller would also need to maintain prescriptions it
receives via patient presentation. The Commission has not received any
comments that alter its understanding that such retention does not
create more than a minimal burden. Further, by retaining a patient's
prescription, a seller is relieved of the burden to verify that
prescription or maintain records of verification. As a result, the
burden from obtaining and retaining prescriptions likely offsets the
burden from making verification requests and storing records of such
requests. Both the FCLCA and the Rule prohibit illegal alteration of a
prescription. The modification of the Rule's definition of alteration
would clarify what constitutes alteration, and permit sellers to avail
themselves of an exception by verifying only the contact lens brand or
manufacturer that consumers indicate is on their prescriptions when
asked by the seller. As a result, all non-prescriber sellers that
qualify as small businesses would need to request and obtain
manufacturer or brand information via website or other consumer
interface, telephone, or in person to qualify for the exception. The
professional skill or time necessary for this task would include
personnel with the skills required to update the website or other
consumer interface and the time it takes to make the updates, or if the
information is relayed over the phone or in person, the additional time
for an employee or agent of the seller to obtain the information. Such
employees would also need to be trained on this requirement. Although there is no associated document retention requirement set
forth in the Rule, the Commission is aware that without the evidence
that the manufacturer or brand provided on the verification request was
the one provided by the customer, the seller would not be able to avail
itself of the exception to illegal alteration. As a result, the
Commission has considered the associated document retention as a new
burden. However, since many contact lens sales by non-prescriber
sellers occur online, the burden of such record retention may be
minimized by the ability to keep electronic sales records. For sales
that occur via telephone or in person, the seller would be required to
maintain records of the request made by, and the information supplied
by, the consumer. The Commission believes that sellers retain phone-
order records in the ordinary course of business and any additional
recordkeeping sellers may do to qualify for the exception is likely to
be minimal.
E. Steps Taken To Minimize the Significant Impact, if Any, of the
Amendments, Including Why Any Significant Alternatives Were Not Adopted
1. Steps and Alternatives for Amendments Affecting Prescribers The Commission considered a number of alternatives to the
requirement for prescribers to request the patient sign a confirmation
of receipt of a contact lens prescription, including signage and
educating consumers about their rights to a contact lens prescription.
The Commission determined that signage would be significantly less
effective than a Confirmation of Prescription Release requirement. It
also determined that consumer education in itself, whether provided via
information entry forms, a patients' bill of rights, advertising, or
public service announcements, would not have a significant impact on
prescriber compliance with automatic prescription release, and would
not increase the Commission's ability to monitor and enforce the
Rule.\628\ In response to commenter concerns about its proposal as
outlined in the NPRM and SNPRM, the Commission took steps to minimize
the impact of the Confirmation of Prescription Release. First, the
Commission included an option for prescribers to satisfy the
confirmation by releasing the prescription electronically. While not
every prescriber will be able to use this option to deliver a
prescription electronically, the Commission is confident that this
option will still reduce the burden for many, especially as more
prescribers move toward electronic recordkeeping. Second, the
Commission excluded from the requirement eye care prescribers who have
no direct or indirect financial interest in the sale of contact lenses.
By more narrowly targeting the requirement to only those with an
incentive to withhold prescriptions, the Commission further reduced the
overall burden and avoided unnecessarily impacting prescribers who are
unlikely to violate the Rule. Third, the Commission reduced the burden
by allowing a significant degree of flexibility in how prescribers
comply with the confirmation requirement. The Final Rule allows
prescribers to craft their own wording for statements confirming
receipt of contact lens prescriptions (on a stand-alone statement, on a
prescriber-retained copy of a prescription, or on a prescriber-retained
copy of an examination receipt), while providing sample language for
prescribers to use, should they not wish to formulate their own
confirmation. This change reduces the possible paperwork burden and
limits potential interference with the prescriber-patient
relationship.\629\
--------------------------------------------------------------------------- \628\ These alternatives and the reasons the Commission found
them to be insufficient alternatives to Confirmation of Prescription
Release are more fully described in Section II.C.6., supra, of this
notice. \629\ In the Final Rule, for instances where a patient refuses
to sign the confirmation, the Commission directs the prescriber to
note the refusal and preserve this record as evidence of compliance.
--------------------------------------------------------------------------- In considering the amendment requiring prescribers to respond to
requests for copies of a prescription within a defined period (forty
business hours), the Commission considered, but rejected, the option to
simply rely on the expectation that all prescribers would fulfill their
responsibilities to their patients. It is the Commission's
understanding that prescribers do not always comply, or comply
expediently, and therefore believes the time-limit requirement is
necessary. In order to minimize the burden on prescribers, however, the
Commission rejected
[[Page 50716]]
commenter requests to make the time limit significantly shorter, such
as eight business hours. As for the new requirement that prescribers
make a notation in the patient's record when responding to such
requests, the Commission declined to shift the recordkeeping burden to
the designated agent making a request because, to determine whether a
particular prescriber is complying with the Rule, the Commission would
need to obtain records from a wide variety of agents.
2. Steps and Alternatives for Amendments Affecting Sellers The Commission did not consider specific alternatives to the Final
Rule's requirement that sellers, when using automated telephone
messages to verify prescriptions, commence the call by identifying it
as a request for prescription verification made in accordance with the
Contact Lens Rule, deliver the required information in a slow and
deliberate manner and at a reasonably understandable volume, and make
the required information repeatable at the prescriber's option.\630\
The Commission included these amendments in the Final Rule to relieve
the burden on prescribers and reduce potential health risks to patients
from incomplete or incomprehensible automated telephone messages.
Specifically, the Commission noted that prescribers must be able to
understand automated messages so they can, if necessary, respond to
sellers to prevent improper sales. Commenters presented additional
suggestions to improve call quality, but did not suggest alternatives
to commencing the call by identifying it as a request for prescription
verification made in accordance with the Contact Lens Rule, and to make
the required information repeatable at the prescriber's option, nor did
they express opposition to such requirements.
--------------------------------------------------------------------------- \630\ The requirements that the seller deliver the required
information in a slow and deliberate manner and at a reasonably
understandable volume have been part of the FTC's prior guidance
that the information be delivered at a volume and cadence that a
reasonable person can understand.
--------------------------------------------------------------------------- The Commission considered whether to require sellers to retain a
sample recording of the standard script leaving blanks for prescription
and patient details instead of recording all calls using automated
telephone messages. However, the Commission determined that a script or
a sample recording would not reveal whether the required information
was transmitted effectively or if, for instance, it was transmitted
before a representative or machine answered, after an answering machine
cut off, when a prescriber's office put the call on hold, or over hold
music, in which case the call could not be used as a basis for the
sale. In addition, a script or sample recording would not permit the
Commission to assess whether a particular call was delivered in a
``slow and deliberate manner'' and at a ``reasonable understandable
volume.'' Without knowing this information, the Commission would be
unable to determine conclusively whether any particular verification
request was valid. Therefore, the Commission did not adopt this
recommendation. With respect to the requirement that sellers accept prescription
presentation, the Commission did not receive any comments opposing this
proposal, and thus did not consider alternatives. In response to
commenter concerns, however, the Commission determined not to permit
sellers to select any method of communication, but opted instead to
maximize the benefits from the amendment by requiring the seller to
present the prescription through the same medium by which the order is
placed, or electronic mail, text message, or file upload. For verification requests, the Commission expressly defined
alteration as occurring when sellers provide prescribers with the name
of a manufacturer or brand other than that specified on a patient's
prescription. However, the Commission provided an exception such that
it would not amount to alteration in instances when sellers verify only
the contact lens brand or manufacturer that consumers indicate is on
their prescriptions after a seller requests that information. As
possible alternatives to these changes, the Commission considered
whether it could instead rely on the new requirements that sellers (a)
provide a method for prescription presentation and (b) meet quality
standards for verification calls, but the Commission determined that
those requirements alone are inadequate to curb the practice of
unlawful substitution to non-prescribed brands through abuse of the
verification system. Although the Commission has previously stated that
a verification request is not valid and does not commence the eight-
business-hour verification period if a seller knows or should know that
the verification request includes a different brand and manufacturer
than that prescribed, the FTC continues to receive reports about the
proliferation of passive verification abuses, and sellers ``gaming the
system'' to substitute a different brand or manufacturer. Furthermore,
without the changes to the definition of alteration, sellers may argue
that they are technically compliant with the Rule because they
submitted verification requests and prescribers had an opportunity to
respond to the requests, and may also argue that they did not have
knowledge that a consumer did not have a prescription for that
manufacturer or brand of lens. The Final Rule amendment will give them
a basis of knowledge by requesting that a consumer state the brand or
manufacturer of her brand of lens. Additionally, the Commission
determined that without the express definition of alteration and the
exception thereto, enforcement would not, in and of itself, be adequate
to protect consumers, because alteration via abuse of the verification
system does not occur with only one bad actor, and because of an
increase in companies that appear to alter prescriptions in this way. Seller 1-800 CONTACTS also commented that the amendment should not
refer to ``brand'' as that language does not appear elsewhere in the
Rule. It pointed out that the Rule defines a prescription as including
a ``material or manufacturer or both'' and that the Commission's
inclusion of the reference to brand imposes an additional limit on
consumer choice that is not required by the Act. 1-800 CONTACTS
requested that the exception to the Rule be applicable to ``providing
the prescriber with the name of a manufacturer or material other than
that specified by the patient's prescriber . . . .'' The reference to
brand in the definition of alteration and in the exception are the only
references to brand in the Rule. However, because many, if not most,
prescriptions list the manufacturer's brand, not the manufacturer or
material, and very few consumers know the manufacturer or material of
contact lens that they wear (typically referring to their lenses by
brand name), the Commission declines to follow 1-800 CONTACTS'
recommendation because many consumers would be unable to respond to a
seller's request. 1-800 CONTACTS expressed concern that the Commission's amendment
might interfere with its ability to improve the user experience. It
indicated that it sells hundreds of brands of lenses and offers
consumers a variety of methods to identify their brand, including drop-
down menus, a search box, and filters that display lenses by brand,
modality, and other parameters and that some consumers do not enter
their brand information on an order form. In response, the Commission,
in the Final Rule, removed the language from its earlier proposal that
sellers must obtain the information
[[Page 50717]]
on ``an order form.'' In comparison, other commenters requested greater
specificity or even prohibitions on the acceptable mechanisms for
sellers to request and consumers to select their brand. In response,
the Commission clarified that, at a minimum, in order for sellers to
consider the consumer's indication of manufacturer or brand as adequate
to qualify for the exception, the manufacturer or brand must be: (1)
Provided in response to a seller's request for the manufacturer or
brand listed on the consumer's prescription; and (2) an affirmative
statement or selection by the consumer, not a preselected or prefilled
entry.\631\
--------------------------------------------------------------------------- \631\ See Section VI.B., supra.
---------------------------------------------------------------------------
XIII. Congressional Review Act Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
the Office of Information and Regulatory Affairs designated these rule
amendments as not a ``major rule,'' as defined by 5 U.S.C. 804(2).
List of Subjects in 16 CFR Part 315 Advertising, Medical devices, Ophthalmic goods and services, Trade
practices. For the reasons discussed in the preamble, the Federal Trade
Commission amends title 16 of the Code of Federal Regulations, part
315, as follows:
PART 315--CONTACT LENS RULE
0
1. The authority for part 315 is revised to read as follows: Authority: 15 U.S.C. 7601-7610.
0
2. Amend Sec. 315.2 by adding in alphabetical order the definitions of
``Provide to the patient a copy'', ``Reasonably understandable volume''
and ``Slow and deliberate manner'' to read as follows:
Sec. 315.2 Definitions.
* * * * * Provide to the patient a copy means giving a patient a copy of his
or her contact lens prescription: (1) On paper; or (2) In a digital format that can be accessed, downloaded, and
printed by the patient. For a copy provided in a digital format, the
prescriber shall identify to the patient the specific method or methods
of electronic delivery to be used, such as text message, electronic
mail, or an online patient portal, and obtain the patient's verifiable
affirmative consent to receive a digital copy through the identified
method or methods; and maintain records or evidence of a patient's
affirmative consent for a period of not less than three years. Such
records or evidence shall be available for inspection by the Federal
Trade Commission, its employees, and its representatives. Reasonably understandable volume means at an audible level that
renders the message intelligible to the receiving audience. Slow and deliberate manner means at a rate that renders the message
intelligible to the receiving audience.
0
3. Amend Sec. 315.3 by:
0
a. Revising paragraphs (a)(1) and (2);
0
b. Adding paragraph (a)(3);
0
c. Revising paragraphs (b)(1) through (3); and
0
d. Adding paragraph (c). The additions and revisions read as follows:
Sec. 315.3 Availability of contact lens prescriptions to patients. (a) In general. When a prescriber completes a contact lens fitting,
the prescriber: (1) Whether or not requested by the patient, shall provide to the
patient a copy of the contact lens prescription; (2) Shall, as directed by any person designated to act on behalf of
the patient, verify the contact lens prescription by electronic or
other means; and (3) Shall, upon request, provide any person designated to act on
behalf of the patient with a copy of the patient's contact lens
prescription by electronic or other means within forty (40) business
hours of receipt of the request. A prescriber shall note in the
patient's record the name of the requester and the date and time that
the prescription was provided to the requester. (b) Limitations. A prescriber may not: (1) Require the purchase of contact lenses from the prescriber or
from another person as a condition of providing a copy of a
prescription under paragraph (a)(1) or (a)(3) of this section or as a
condition of verification of a prescription under paragraph (a)(2) of
this section; (2) Require payment in addition to, or as part of, the fee for an
eye examination, fitting, and evaluation as a condition of providing a
copy of a prescription under paragraph (a)(1) or (a)(3) of this section
or as a condition of verification of a prescription under paragraph
(a)(2) of this section; or (3) Require the patient to sign a waiver or release as a condition
of releasing or verifying a prescription under paragraph (a)(1),
(a)(2), or (a)(3) of this section. (c) Confirmation of prescription release. (1)(i) Upon completion of
a contact lens fitting, the prescriber shall do one of the following: (A) Request that the patient acknowledge receipt of the contact
lens prescription by signing a statement confirming receipt of the
contact lens prescription; (B) Request that the patient sign a prescriber-retained copy of a
contact lens prescription that contains a statement confirming receipt
of the contact lens prescription; (C) Request that the patient sign a prescriber-retained copy of the
receipt for the examination that contains a statement confirming
receipt of the contact lens prescription; or (D) If a digital copy of the prescription was provided to the
patient (via methods including an online portal, electronic mail, or
text message) in compliance with paragraph (a)(1) of this section,
retain evidence that the prescription was sent, received, or made
accessible, downloadable, and printable. (ii) If the prescriber elects to confirm prescription release via
paragraphs (c)(1)(i)(A), (B), or (C) of this section, the prescriber
may, but is not required to, use the statement, ``My eye care
professional provided me with a copy of my contact lens prescription at
the completion of my contact lens fitting'' to satisfy the requirement. (iii) In the event the patient declines to sign a confirmation
requested under paragraph (c)(1)(i)(A), (B), or (C) of this section,
the prescriber shall note the patient's refusal on the document and
sign it. (2) A prescriber shall maintain the records or evidence required
under paragraph (c)(1) of this section for a period of not less than
three years. Such records or evidence shall be available for inspection
by the Federal Trade Commission, its employees, and its
representatives. (3) Paragraphs (c)(1) and (c)(2) of this section shall not apply to
prescribers who do not have a direct or indirect financial interest in
the sale of contact lenses, including, but not limited to, through an
association, affiliation, or co-location with a contact lens seller.
0
4. Amend Sec. 315.5 by:
0
a. Redesignating paragraphs (d), (e), (f), and (g) as paragraphs (e),
(f), (h), and (i), respectively;
0
b. Adding new paragraph (d);
0
c. Revising newly redesignated paragraph (f);
0
d. Adding new paragraph (g);
0
e. Adding new paragraph (h)(2)(iii);
0
f. Revising newly redesignated paragraph (i). The additions and revisions read as follows:
[[Page 50718]]
Sec. 315.5 Prescriber verification.
* * * * * (d) Automated telephone verification messages. If a seller verifies
prescriptions through calls that use, in whole or in part, an automated
message, the seller must: (1) Record the entire call; (2) Commence the call by identifying it as a request for
prescription verification made in accordance with the Contact Lens
Rule; (3) Deliver the information required by paragraph (b) of this
section in a slow and deliberate manner and at a reasonably
understandable volume; and (4) Make the information required by paragraph (b) of this section
repeatable at the prescriber's option.
* * * * * (f) No alteration of prescription. A seller may not alter a contact
lens prescription. In the context of prescription verification,
alteration includes, but is not limited to, providing the prescriber
with the name of a manufacturer or brand other than that specified by
the patient's prescription, unless such name is provided because the
patient entered or orally provided it when asked for the manufacturer
or brand listed on the patient's prescription. Notwithstanding the
preceding sentences, for private label contact lenses, a seller may
substitute for contact lenses specified on a prescription identical
contact lenses that the same company manufactures and sells under
different labels. (g) Seller requirement to accept prescription presentation: A
seller shall provide a prominent method, and a clear and prominent
disclosure of that method, for the patient to present the seller with a
copy of the patient's prescription. Such method and the disclosure
shall be provided prior to requesting a prescriber's contact
information for verification of the prescription; provided, however, in
the case of an order placed by telephone, a seller shall comply by
providing a disclosure of the method prior to requesting a prescriber's
contact information for verification of the prescription. The method to
present the prescription shall be provided through (i) the same medium
by which the order is placed, or (ii) electronic mail, text message, or
file upload. (h) * * * (2) * * * (iii) If the communication occurs via telephone and uses an
automated message, the complete recording required pursuant to
paragraph (d)(1) of this section.
* * * * * (i) Recordkeeping requirement--Saturday business hours. A seller
that exercises its option to include a prescriber's regular Saturday
business hours in the time period for a request for a copy of the
prescription specified in Sec. 315.3(a)(3) or for verification
specified in paragraph (c)(3) of this section shall maintain a record
of the prescriber's regular Saturday business hours and the basis for
the seller's actual knowledge thereof. Such records shall be maintained
for a period of not less than three years, and these records must be
available for inspection by the Federal Trade Commission, its
employees, and its representatives. By direction of the Commission.
April J. Tabor,
Secretary.
[FR Doc. 2020-14206 Filed 8-14-20; 8:45 am]
BILLING CODE 6750-01-P
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