[Federal Register Volume 69, Number 127 (Friday, July 2, 2004)]
[Rules and Regulations]
[Pages 40482-40511]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-14969]



[[Page 40481]]

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Part III





Federal Trade Commission





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16 CFR Parts 315 and 456



Contact Lens Rule; Final Rule

  Federal Register / Vol. 69, No. 127 / Friday, July 2, 2004 / Rules 
and Regulations  

[[Page 40482]]


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FEDERAL TRADE COMMISSION

16 CFR Parts 315 and 456

RIN 3084-AA95


Contact Lens Rule

AGENCY: Federal Trade Commission.

ACTION: Final rule.

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SUMMARY: In this document, the Federal Trade Commission (the 
``Commission'') issues a Final Rule implementing the Fairness to 
Contact Lens Consumers Act (the ``Act''), 15 U.S.C. 7601 et seq., which 
provides for the availability of contact lens prescriptions to patients 
and the verification of contact lens prescriptions by prescribers. This 
document also implements two clerical amendments to the Commission's 
Ophthalmic Practices Rules to clarify the distinction between those 
Ophthalmic Practices Rules and the Contact Lens Rule.

DATES: Effective Date: The Rule will become effective on August 2, 
2004.

ADDRESSES: Requests for copies of the Rule and the Statement of Basis 
and Purpose should be sent to the Commission's Public Reference Branch, 
Room 130, Federal Trade Commission, 600 Pennsylvania Avenue, NW., 
Washington, DC 20580. The complete record of this proceeding is also 
available at that address. Relevant portions of the proceeding, 
including the Rule and Statement of Basis and Purpose, are also 
available at the Commission's Web site, http://www.ftc.gov.

FOR FURTHER INFORMATION CONTACT: Division of Advertising Practices, 
Thomas Pahl or Char Pagar [(202) 326-3528], Federal Trade Commission, 
Bureau of Consumer Protection, Division of Advertising Practices, 600 
Pennsylvania Avenue, NW., Washington, DC 20580.

SUPPLEMENTARY INFORMATION: The Contact Lens Rule (``the Rule'') 
implements the requirements of the Fairness to Contact Lens Consumers 
Act (``the Act''), 15 U.S.C. 7601-7610. Specifically, the Rule: (1) 
Requires prescribers (such as optometrists and ophthalmologists) to 
provide patients with a copy of their contact lens prescription 
immediately upon completion of a contact lens fitting; (2) requires 
prescribers to provide or verify contact lens prescriptions to any 
third party designated by a patient; (3) prohibits prescribers from 
placing certain conditions on the release or verification of a contact 
lens prescription; (4) limits the circumstances under which a provider 
can require payment for an eye exam prior to releasing a contact lens 
prescription to a patient; (5) requires contact lens sellers to either 
obtain a copy of a patient's prescription or verify the prescription 
before selling contact lenses; (6) addresses the issue of private label 
contact lenses; (7) sets minimum expiration dates for contact lens 
prescriptions; (8) prohibits representations that contact lenses may be 
obtained without a prescription; (9) prohibits prescribers from using 
or requiring patients to sign any waiver or disclaimer of liability for 
the accuracy of an eye examination; (10) defines relevant terms; (11) 
establishes that violations of the proposed Rule will be treated as 
violations of a rule defining an unfair or deceptive act or practice 
under section 18 of the Federal Trade Commission Act; and (12) provides 
that State and local laws and regulations are preempted under certain 
circumstances.

Statement of Basis and Purpose

I. Introduction

    On December 6, 2003, President Bush signed the Act into law.\1\ 
Among other things, the Act requires that prescribers, including 
optometrists and ophthalmologists, provide contact lens prescriptions 
to their patients upon the completion of a contact lens fitting.\2\ The 
Act also mandates that prescribers verify contact lens prescriptions to 
third-party contact lens sellers who are authorized by consumers to 
seek such verification.\3\ The Act directs the Commission to prescribe 
implementing rules.\4\ Any violation of the Act or its implementing 
rules constitutes a violation of a rule under Section 18 of the Federal 
Trade Commission Act, 15 U.S.C. 57a, regarding unfair or deceptive acts 
or practices.\5\ The Act authorizes the Commission to investigate and 
enforce the Act in the same manner, by the same means, and with the 
same jurisdiction, powers, and duties, as a trade regulation rule under 
the Federal Trade Commission Act.\6\
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    \1\ 15 U.S.C. 7601-7610 (Pub. L. 108-164).
    \2\ Id. at 7601.
    \3\ Id. at 7601, 7603.
    \4\ Id. at 7607.
    \5\ Id. at 7608.
    \6\ Id.
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    The Commission published a Notice of Proposed Rulemaking and 
Request for Public Comment (``NPRM'') in the Federal Register on 
February 4, 2004,\7\ and the 60-day comment period closed on April 5, 
2004. The Commission received more than 7,000 comments. The commenters 
included nearly 6,000 individual consumers as well as prescribers, 
their State and national trade associations, contact lens sellers, 
State attorneys general, and others. Based on the rulemaking record, 
including the comments received, the Commission has modified the 
proposed Rule published in the NPRM and now promulgates a final rule as 
described in this Statement of Basis and Purpose.
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    \7\ 69 FR 5440 (Feb. 4, 2004).
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    In addition, the Commission enforces the Ophthalmic Practice 
Rules,\8\ which primarily require the release of eyeglass prescriptions 
to patients at the completion of an eye examination, and prohibit eye 
care practitioners from placing certain conditions on such release. The 
Commission today implements two clerical amendments, set forth in 
section III below, to clarify the relationship between the Ophthalmic 
Practices Rules and the Contact Lens Rule.
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    \8\ 16 CFR part 456.
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II. The Rule

    As noted above, the Commission published the proposed rule and 
accompanying analysis in the Federal Register on February 4, 2004.\9\ 
Unless specifically modified herein, all of the analysis accompanying 
the proposed rule in the NPRM is adopted and incorporated into this 
Statement of Basis and Purpose for the final rule.
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    \9\ 69 FR 5440 (Feb. 4, 2004).
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A. Section 315.1: Scope of Regulations

    Section 315.1 of the proposed Rule described the basis for, and the 
general scope of, the regulations in part 315--the ``Contact Lens 
Rule''--which implements the Fairness to Contact Lens Consumers Act. 
The Commission received no comments on this provision and adopts it 
without modification.

B. Section 315.2: Definitions

1. Definition of ``Business Hour''
    Congress recognized that consumers may be harmed if they face undue 
delays in receiving their contact lenses from a seller. Congress also 
acknowledged that consumers may be harmed if a seller provides contact 
lenses to a consumer based on an expired, inaccurate, or otherwise 
invalid prescription. Congress balanced these considerations in section 
4(d)(3) of the Act by allowing a seller to treat a prescription as 
``verified'' and sell contact lenses to a consumer if a prescriber has 
not notified the seller ``within eight (8) business hours, or a similar 
time as defined by the Commission,'' that a prescription is expired, 
inaccurate, or otherwise invalid.\10\
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    \10\ 15 U.S.C. 7603(d)(3).

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[[Page 40483]]

    The Act does not define ``business hour'' or set forth how to 
calculate ``eight business hours.'' The purpose of the verification 
period established under the Act, however, is to give prescribers an 
opportunity to determine whether prescriptions are expired, inaccurate, 
or otherwise invalid. Because prescribers make this determination 
during the hours that they are open, Congress apparently intended 
prescribers to have eight hours during which they are open for business 
to respond to a verification request.
    Accordingly, in the proposed Rule, the Commission defined 
``business hour'' as an hour between 9 a.m. and 5 p.m., during a 
weekday excluding Federal holidays. The definition further specified 
that for verification requests received between 9 a.m. and 5 p.m., 
``eight (8) business hours'' would be calculated from the first 
business hour that occurs after the seller provides the prescription 
verification request to the prescriber, and conclude after eight 
business hours have elapsed. For verification requests received by a 
prescriber during non-business hours, the calculation of eight business 
hours would begin at 9 a.m. on the next weekday that is not a Federal 
holiday, and would end at 9 a.m. on the following weekday.
    For the reasons discussed below, the Commission retains the 
definition of ``business hour'' as an hour between 9 a.m. and 5 p.m., 
during a non-holiday weekday. However, the Commission has revised the 
rule to provide sellers with the option of counting a prescriber's 
regular business hours on Saturdays, so long as the seller has actual 
knowledge of these hours. In addition, the Commission has revised the 
calculation of ``eight (8) business hours'' so that the verification 
period ends--and a seller may sell contact lenses--as soon as eight 
business hours have elapsed. Finally, the Commission clarifies that 
business hours are to be determined based on the time zone of the 
prescriber.
a. Actual Hours
    The Commission's proposed definition of ``business hour'' generated 
a substantial number of public comments. A number of comments sought a 
definition that reflects prescribers' actual business hours. For 
example, one large Internet-based contact lens seller urged that 
sellers should have the option of determining the actual business hours 
of a particular prescriber and using those as an alternative to the 
Rule's ``default'' business hours.\11\
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    \11\ 1-800 CONTACTS (Comment 1140). The Mercatus Center 
at George Mason University (Regulatory Studies Program) (Comment 
1087) made a similar proposal.
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    A number of prescribers and their trade associations also sought a 
definition of ``business hours'' that reflects actual business hours. 
These commenters, however, explained that the Commission's proposed 
definition did not take into account days when a prescriber's office is 
closed and the prescriber cannot respond to a verification request 
within eight business hours. These commenters sought various exceptions 
or extensions to the business hour definition to accommodate 
circumstances such as days the prescriber's office is regularly closed; 
days the prescriber is performing surgery; and days a prescriber is out 
of the office for continuing education, illness, vacation, or inclement 
weather.\12\ Many commenters also sought an exception for so-called 
``satellite offices,'' described as prescriber offices commonly located 
in rural areas and open only one or two days per week.\13\ Other 
commenters emphasized generally that actual prescriber business hours 
vary from those of other retail and Internet businesses, and urged the 
Commission to craft a rule that ``serves the best interests and safety 
of the consumers, not just those of contact lens sellers.'' \14\
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    \12\ E.g., American Optometric Association (Comment 
1149) (citing continuing education, vacation and illness); 
American Academy of Ophthalmology (Comment 1057) (9-5 
Monday through Friday does not address realities of ophthalmologic 
practice; approximately 40% of its members are solo practitioners; 
Rule should make exceptions for surgery days, continuing education, 
a weekday when the office is regularly closed, State or religious 
holidays, solo practitioner illness and/or vacation days, and for 
local, State, or federally mandated jury duty); New Jersey Academy 
of Ophthalmology (Comment 1126) (most physicians are closed 
one day per week and close for vacation several weeks per year; 
requiring coverage from 9-5 every Monday through Friday is 
unrealistic and unduly burdensome); Nebraska Optometric Association 
(Comment 1083) (seeking ``reasonable extensions'' of eight-
hour rule when doctor is absent for continuing education, vacation, 
or illness); Ohio Optometric Association (Comment  1151) 
(same, citing continuing education obligations, illness, vacation, 
periods of unplanned practice interruptions); New Mexico Optometric 
Association (Comment  1081) (continuing education, vacation 
and illness); C. Lesko, M.D., FACS (Comment 960) (performs 
surgery two days a week); Kansas Optometric Association (Comment 
1153) (citing continuing education (24 hours per year in 
Kansas), vacation and illness); American Society of Cataract and 
Refractive Surgery (Comment 1148); E. Lamp, O.D. (Comment 
714).
    \13\ E.g., Kansas Optometric Association (Comment 1153) 
(citing approximately 60 satellite offices in State); Kentucky 
Optometric Association (Comment 1101); Colorado Optometric 
Association (Comment 1067); American Optometric Association 
(Comment 1149); Nebraska Optometric Association (Comment 
1083) (seeking ``reasonable extension'' of eight-hour rule 
for verifications sent to satellite offices); Pennsylvania 
Optometric Association (Comment 959); Ohio Optometric 
Association (Comment  1151); New Mexico Optometric 
Association (Comment  1081); B.L.Whitesell, O.D. (Comment 
1115); S. Wagner, M.D. (Comment 928). A number of 
these commenters explained that the records for patients of 
satellite offices are often kept at the satellite office and thus, 
on days the office is not open, are not readily accessible for 
verification during an eight-hour window.
    \14\ A.L. Warner (Comment 706).
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    Few of the voluminous comments received on this issue proposed a 
means of accommodating the requested exceptions. Some suggested 
providing a longer verification period generally,\15\ while others 
suggested that the prescriber's office be permitted to inform the 
seller of the prescriber's return date, or the date on which the office 
would next be open, at which time the eight business hour verification 
period would commence.\16\ One commenter suggested that, prior to 
requesting verification, a seller should first have to determine that 
the prescriber's office is open and that the prescriber will be present 
in the office during the next eight hours.\17\
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    \15\ E.g., Texas Ophthalmological Association (Comment 
1117).
    \16\ E.g., American Optometric Association (Comment 
1149); Ohio Optometric Association (Comment  
1151); American Society of Cataract and Refractive Surgery (Comment 
1148) (prescriber could be required to leave information on 
answering service, voicemail, or answering machine); B.L. Whitesell, 
O.D. (Comment 1115) (willing to tell sellers what his hours 
are); K. Driver, O.D. (Comment 273) (same); S. Wagner, M.D. 
(Comment 928) (Rule should allow prescriber to respond 
within eight hours to a faxed request to a satellite office, 
providing a specific statement that the records are in a remote 
location and will be available for review on a certain date). See 
also Pennsylvania Optometric Association (Comment 959) 
(stating some of its members have contacted seller and asked them to 
fax verification request to the main office but seller refused).
    \17\ Tupelo Eye Clinic/Chappell (Comment 11). Other 
commenters made similar suggestions. E.g., New Jersey Academy of 
Ophthalmology (Comment 1126) (suggesting physicians be 
permitted extra time beyond the eight business hours to comply, or 
exempting from liability physicians who could not verify a 
prescription due to office closure); Your Family Eye Doctors, Inc. 
(Comment 705) (recommending 24 business hours for 
verification rather than eight, to accommodate satellite offices); 
G. Lozada (Comment 1063) and Opticians Association of Ohio 
(Comment 1156) (also suggesting 24 hours); American Academy 
of Ophthalmology (Comment 1057) (suggesting time period for 
verification begin at 9:00 a.m. on the next business weekday that 
the office is open).
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    Having considered these comments, the Commission declines to adopt 
an actual hours or other prescriber-specific approach to business 
hours. Evidence in the record indicates that there are more than 50,000 
prescribers in the United

[[Page 40484]]

States,\18\ and that actual business hours vary widely among them.\19\ 
It likely would be difficult and burdensome--perhaps impossible--for 
some sellers to determine and keep track of the actual hours of 50,000 
prescribers.\20\ By contrast, a general rule using a uniform definition 
of business hours for all prescribers provides clarity and relative 
ease of compliance and enforcement. Moreover, there does not appear to 
be any practical way to accommodate the myriad circumstances during 
which the offices of 50,000 individual prescribers may be closed or 
otherwise not able to respond to a prescription verification 
request.\21\
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    \18\ See, e.g., American Optometric Association (Comment 
1137) (representing some 33,000 members). In addition, the 
American Academy of Ophthalmology has represented to Commission 
staff that it represents approximately 17,000 members.
    \19\ See, e.g., comments discussed supra; 1-800 CONTACTS 
(Comment 1140) at attachment 32 (survey of prescribers' 
actual hours).
    \20\ Cf. AC Lens (Comment  974) (arguing that Rule 
should not exclude State or local holidays as business days because 
doing so would put unreasonable burden on smaller entities in other 
States that have no practical way to track down such holidays in all 
50 States).
    \21\ The suggestion that a prescriber's staff be permitted to 
contact the seller and inform them of the prescriber's absence--and 
thereby obtain an extension to the eight hour verification period--
is simply not practical. Such a system would work only if 
prescribers' offices were staffed on the relevant day, and the 
public comments made clear that in many cases the office is simply 
closed--e.g., because it is a satellite office, the office is 
regularly closed on a certain weekday, or due to inclement weather.
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    In addition, several commenters, including optometric associations 
and one State board, voiced support for the proposed definition, 
particularly its limitation to weekdays and non-holidays.\22\ One 
commenter stated that ``it would be impractical for the Commission to 
craft store- or prescriber-specific rules.'' \23\ Similarly, other 
commenters opposed exceptions or extensions for days a prescriber's 
office may be closed for vacation, State or local holidays, or other 
reasons. These commenters argued that making such exceptions would 
impose undue burdens on small sellers to keep track of such closures, 
thereby harming their ability to compete with larger sellers. These 
commenters also argued that it would unreasonably delay delivery of 
contact lenses to consumers.\24\
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    \22\ E.g., Florida Board of Optometry (Comment 1100); 
National Association of Optometrists and Opticians (Comment 
1146) (supporting limitation to weekdays and non-holidays); 
American Optometric Association (Comment 1149) (supporting 
proposed definition because it ``recognizes the fact that while some 
offices are open on some Saturdays, most are not open every 
Saturday, and many are not open any Saturday'').
    \23\ National Association of Optometrists and Opticians (Comment 
1146).
    \24\ AC Lens (Comment  974); R.Weigner (Comment 
1118) (information about State and local holidays is not 
available to national mail order and internet firms; even if it were 
available, it would be cost-prohibitive to implement and would 
stifle competition).
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b. General Rule
    Having determined that a general rule using uniform business hours 
is preferable to an actual hours standard, the Commission discusses 
below the remaining comments received on its proposed definition and 
the revisions the Commission has made to the Rule in response.
1. Monday Through Friday
    A number of commenters offered alternative definitions of business 
hours. A few commenters, including the California Board of Optometry, 
urged the Commission to consider adopting a verification time period 
that tracks California State law.\25\ Under California's prescription 
release law, a prescription is verified if the prescriber does not 
respond by or before the same time on the next business day after the 
seller requested verification, or by 2 p.m. the next business day, 
whichever is earlier.\26\
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    \25\ E.g., California Board of Optometry (Comment 21); 
Hon. Jim Matheson, U.S. House of Rep. (Comment 1237); L. 
Correa, California Assembly Rep. (Comment 1142); Citizens 
for a Sound Economy (Comment 1108) (noting the California 
law ``has been in place for over a year, and has worked well''); 
William F. Shughart, II, Ph.D. (Comment 975) (on behalf of 
1-800-CONTACTS).
    \26\ California's statute took effect in January 2003, just over 
one year before the Fairness to Contact Lens Consumers Act took 
effect.
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    One contact lens seller, Wal-Mart, proposed a ``24-hour'' rule, 
somewhat similar to California's, under which the verification period 
would expire at the same time on the next business day after the 
prescriber received the verification request.\27\
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    \27\ Wal-Mart Optical Division (Comment 1070).
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    Another seller, 1-800 CONTACTS, proposed defining ``business 
hours'' as 9 a.m. to 6:30 p.m., Monday through Friday, and 9 a.m. to 4 
p.m. on Saturday, based on a survey of actual prescriber business 
hours.\28\ The survey itself concluded that a ``standardized work 
week'' for optical goods retailers is 9 a.m. to 6:15 p.m. Monday 
through Thursday, 9 a.m. to 6 p.m. Friday, and 9 a.m. to 4:15 p.m. 
Saturday.\29\
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    \28\ 1-800 CONTACTS (Comment 1140). The survey, 
submitted as part of the record in this proceeding, was prepared by 
Synovate, a market research firm, and consisted of 300 telephone 
interviews for each of four retail channels--independent 
optometrists, ophthalmologists, optical retail chains (e.g., 
LensCrafters, Pearle Vision), and mass merchandisers (e.g., Wal-
Mart, Target, Costco)--asking about store business hours. See 
Comment 1140, attachment 32. From the interview results, 
average opening and closing times were determined for each day of 
the week for each retail channel as follows:
    Mass merchandisers: approximately 9:15 a.m. to 8:35 p.m. Monday 
through Friday, Saturday 8:45 a.m. to 7:25 p.m., Sunday 11:25 a.m. 
to 5:05 p.m.
    Retail optical chains: approximately 9:45 a.m. to 7:25 p.m. 
Monday through Thursday, Friday 9:40 a.m. to 7:15 p.m., Saturday 
9:40 a.m. to 6:05 p.m., Sunday 11:35 a.m. to 5:15 p.m. (49% are 
closed Sunday).
    Independent optometrists: approximately 9 a.m. to 5:50 p.m. 
Monday, Tuesday, Thursday, Wednesday 9 a.m. to 5:35 p.m., Friday 
8:50 a.m. to 5:20 p.m., Saturday 9 a.m. to 2:40 p.m. (39% are closed 
Saturday, 91% are closed Sunday).
    Ophthalmologists: approximately 8:35 a.m. to 5:10 p.m. Monday 
through Thursday, Friday 8:30 a.m. to 4:35 p.m., Saturday 8:40 a.m. 
to 1:25 p.m. (75% are closed Saturday, 98% are closed Sunday).
    [For purposes of simplicity, the Commission has rounded off some 
of the averages set forth in the survey results to the closest 5-
minute increment.] Then, final average daily opening and closing 
times--combining all four channels--were determined by weighting 
each channel's average to match the actual incidence of lenses 
dispensed among the four channels.
    \29\ See Comment 1140, attachment 32.
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    Finally, a group of 34 State Attorneys General commented that the 
proposed definition was too narrow because many prescribers are open 
longer hours and on weekends.\30\ The Attorneys General offered three 
alternatives, with a preference for a definition that would allow the 
eight-hour verification period to end when the eight business hours 
elapse, not at the start of the next business hour.\31\
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    \30\ State Attorneys General (Comment 1114). This 
comment represented the views of the Attorneys General representing 
Alabama, Arizona, California, Colorado, Connecticut, Delaware, 
Hawaii, Iowa, Louisiana, Maine, Maryland, Massachusetts, Michigan, 
Minnesota, Mississippi, Missouri, Nevada, New York, North Dakota, 
Commonwealth of the Northern Mariana Islands, Ohio, Oklahoma, 
Oregon, Rhode Island, South Carolina, South Dakota, Utah, Virginia, 
Washington, West Virginia, Wisconsin, and Wyoming. The Attorney 
General of Idaho filed a separate comment (Comment 1176) 
joining the other States.
    The Independent Women's Forum (Comment 1236) raised 
many of the same arguments as the State Attorneys General, and 
argued that the proposed definition of ``business hours'' would 
``seriously undermine[] women's autonomy by reversing the 
conveniences that have been created, in part, to support working 
women and mothers.'' See also Hon. J. Sensenbrenner (Comment 
 1246) (arguing proposed definition ``bears no relation to 
the way either consumers or retailers behave''); Progressive Policy 
Institute (Comment 1141) (recommending broader definition 
of business hour because eye care providers can sell contact lenses 
to consumers any time they are open but would only have to verify 
prescriptions between 9-5 on weekdays); Americans for Prosperity 
(Comment 1145) (proposed definition is not grounded in 
actual practices of the eye care industry).
    \31\ The other alternatives were: (1) Using an ``actual hours'' 
standard under which sellers would be obligated to know the actual 
business hours of each prescriber, and would be permitted to presume 
verification (and ship an order) after the prescriber had received 
the request and been open for eight business hours; and (2) allowing 
sellers the option of using the 9 a.m. to 5 p.m. non-holiday weekday 
definition or the actual prescriber business hours. See Comments 
1114, 1176.

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[[Page 40485]]

    The Commission addresses the commenters' specific proposals in 
detail below. However, having considered the comments, the Commission 
has decided to retain the proposed definition of ``business hour'' as 
an hour between 9 a.m. to 5 p.m. on a non-holiday weekday. Evidence in 
the record clearly indicates that the 50,000 prescribers in the United 
States vary as to their actual business hours--in some cases widely. 
However, the Act clearly contemplates that prescribers should have a 
reasonable opportunity when they are open to respond to verification 
requests. The evidence indicates that most prescribers are open Monday 
through Friday, and that most are open for at least eight hours per 
day. Some appear to open earlier than 9 a.m., and some appear to be 
open after 5 p.m., but a 9 a.m. to 5 p.m. rule generally should provide 
these prescribers eight hours during which they are actually open to 
respond to prescription verification requests.\32\ Moreover, such a 
general rule should be easy for sellers and prescribers to apply, 
because eight business hours would usually end at the exact same time 
on the following business day. For example, if a verification request 
is received at 2 p.m. on a Tuesday, the prescriber would have until 2 
p.m. on Wednesday to respond.
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    \32\ The Commission notes that this rule has a similar practical 
effect as the California model and the ``24-hour rule'' promoted by 
a number of commenters. In many cases, the verification period will 
expire at the same time, on the next business day, after the 
prescriber receives the request, regardless of which model is 
utilized. For example, a request received at 10 a.m. on a Tuesday 
would be deemed verified at 10 a.m. on Wednesday under the 
Commission's definition, the California model, or the 24-hour rule. 
In some instances, the Commission's Rule will result in quicker 
verification than under other proposed models; for requests received 
prior to 9 a.m. on a Monday through Friday, the prescription will be 
verified at 5 p.m. that same day rather than at 9 a.m. the following 
business day under the California model or the 24-hour rule.
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2. Saturday
    Several commenters urged the Commission to include Saturday 
business hours in the Rule's definition of ``business hours.'' \33\ 
Sellers argued that many prescribers are, in fact, open on Saturdays, 
and that current retail operations in the United States typically 
include Saturday business hours.\34\ The California Board of Optometry 
noted that California's prescription release law recognizes Saturday as 
a business day--``to accommodate the operational needs of contact lens 
sellers''--and argued this model has proven successful.\35\
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    \33\ E.g., California Board of Optometry (Comment 21); 
AC Lens (Comment  974); Costco Wholesale Corporation 
(Comment 1061); 1-800 CONTACTS (Comment 1140); 
Wal-Mart Optical Division (Comment 1070); Citizens for a 
Sound Economy (Comment 1108).
    \34\ E.g., 1-800 CONTACTS (Comment 1140); Costco 
Wholesale Corporation (Comment 1061); See also Wal-Mart 
(Comment 1070) (arguing that many working people can only 
shop in the evening, and that ``contact lens prescribers should be 
presumed to work normal business hours on days when most other 
people work, whether or not they actually do so'').
    \35\ California Board of Optometry (Comment 21). By 
contrast, however, the California Optometric Association argued 
against including Saturday business hours. See Comment 
1158.
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    Other commenters, however, pointed out that many prescribers are 
not open on Saturdays.\36\ The evidence in the record supports this 
argument, indicating that a significant number of prescribers are not 
regularly open on Saturdays. Survey data indicates that 39% of 
optometrists and 75% of ophthalmologists are closed on Saturday,\37\ 
and that these groups issue a substantial majority of contact lens 
prescriptions. This conclusion is generally consistent with the 
estimates that some prescribers made in their comments.\38\
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    \36\ E.g., National Association of Optometrists and Opticians 
(Comment 1146); American Optometric Association (Comment 
1149).
    \37\ See 1-800 CONTACTS (Comment 1140) at attachment 
32.
    \38\ National Association of Optometrists and Opticians (Comment 
1146) (estimating more than half practitioners are not open 
on Saturdays; supporting limitation to non-holiday weekdays); 
American Optometric Association (Comment 1149) (supporting 
proposed definition of business hours because it ``recognizes the 
fact that while some offices are open on some Saturdays, most are 
not open every Saturday, and many are not open any Saturday'').
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    Based on the comments and evidence, the Commission has revised the 
Rule to give sellers the option of determining whether an individual 
prescriber in fact has regular Saturday business hours, and, if so, to 
include those hours in the eight-hour verification period prescribed in 
section 315.5(c)(3). A rule requiring that Saturday hours be counted as 
business hours would deny many prescribers who are not open a 
reasonable opportunity to respond to prescription verification 
requests. At the same time, not counting Saturdays at all would deny 
consumers the opportunity to have their prescriptions verified by those 
prescribers who are open, and to receive their lenses more quickly.
    Because it may be burdensome for some sellers to obtain actual 
knowledge of prescribers' Saturday business hours,\39\ the Commission 
concludes that the Rule should provide sellers the option of counting 
those hours, rather than requiring them to do so. This approach will 
enable a consumer whose prescriber is open on Saturday, and who wants 
to receive lenses as quickly as possible, to find a seller that will 
determine the prescriber's Saturday hours. In addition, this approach 
should be easy for prescribers to implement, because only those that 
are open will have to respond to verification requests on Saturdays.
---------------------------------------------------------------------------

    \39\ Cf. AC Lens (Comment  974) (arguing that Rule 
should not exclude State or local holidays as business days because 
doing so would put unreasonable burden on smaller entities in other 
States that have no practical way to track down such holidays in all 
50 States).
---------------------------------------------------------------------------

    To facilitate the use of Saturday business hours, the final Rule 
incorporates two related revisions to the proposed Rule. First, a 
seller that exercises its option to count a prescriber's regular 
Saturday business hours must state those hours clearly on the 
verification request.\40\ This requirement will alert the prescriber 
that the seller is in fact counting Saturday hours--so that the 
prescriber can respond appropriately--and also provide an opportunity 
for the prescriber to notify the seller if the seller uses the wrong 
hours. Second, a seller exercising its option to count a prescriber's 
regular Saturday business hours must maintain a record of those hours 
and the basis for the seller's actual knowledge of what those hours 
are--i.e., how the seller determined the hours.\41\ These related 
provisions are intended to promote accuracy by sellers and facilitate 
enforcement.
---------------------------------------------------------------------------

    \40\ See discussion of section 315.5(b) infra.
    \41\ See discussion of section 315.5(g) infra.
---------------------------------------------------------------------------

3. Sunday
    The proposed definition of ``business hour'' excluded Sundays. The 
Commission did not receive any comments advocating the inclusion of 
Sundays in business hours. The evidence in the record also suggests 
that most prescribers are closed that day.\42\ Accordingly, the 
Commission retains the exclusion of Sundays from the definition of 
business hour.
---------------------------------------------------------------------------

    \42\ See, e.g., 1-800 CONTACTS (Comment 1140) at 
attachment 32 (indicating 49% of retail optical chains, 91% of 
independent optometrists, and 98% of ophthalmologists are closed on 
Sunday).
---------------------------------------------------------------------------

4. Federal Holidays
    The Commission's proposed definition of ``business hour'' did not 
count Federal holidays. One commenter suggested that the definition 
should include all Federal holidays except the ``major'' ones--i.e., 
Christmas, New Year's Day, and Thanksgiving--because ``most 
businesses'' are open on the other Federal holidays.\43\ The record in 
this

[[Page 40486]]

proceeding, however, does not provide evidence indicating that most 
prescribers are open on the other Federal holidays. Because the Act is 
intended to give prescribers eight business hours during which they are 
open to respond to a verification request, the Commission declines to 
count ``non-major'' Federal holidays in the definition of business hour 
and, accordingly, retains the proposed definition of ``business hour'' 
as excluding Federal holidays.
---------------------------------------------------------------------------

    \43\ Wal-Mart Optical Division (Comment 1070). See also 
AC Lens (Comment 974) (arguing that Federal holidays should 
only be the major ones when majority of retail businesses are 
closed).
---------------------------------------------------------------------------

c. Calculation of Eight Business Hours
    The Commission received a number of comments on its proposed method 
of calculating eight business hours, some of which are discussed above. 
Under the proposed Rule, the eight-hour verification period would have 
expired--and a seller could ship a customer's order--at the start of 
the next business hour after eight such hours had elapsed. Overall, 
these comments objected to the ``eight-hours-plus-one-day'' 
verification period that would result in some circumstances.\44\ For 
example, the State Attorneys General argued that the eight hours should 
not exceed one business day; otherwise, it would undermine the Act's 
intent to increase consumer choice and convenience.\45\ They pointed 
out that the Act deems a prescription verified if the prescriber does 
not respond ``within'' eight hours. The proposed Rule's requirement 
that seller wait longer than those eight hours--and often an extra 
day--before shipping is not justified and likely will have 
anticompetitive effects.\46\
---------------------------------------------------------------------------

    \44\ E.g., Hon. J. Sensenbrenner (Comment  1246) 
(objecting to the eight-hours-plus-one-day calculation of eight 
business hours).
    \45\ State Attorneys General (Comments 1114, 
1176).
    \46\ See also The Independent Women's Forum (Comment 
1236) (objecting to ``eight-hours-plus-one-day'' 
calculation); Hon. J. Sensenbrenner (Comment 1246) (same). 
In addition, hundreds of consumers stated that an eight-hour-plus-
one-day verification period was too long. See, e.g., Comments 
142, 143, 431, 463, 555, 571, 602-05, 616, 617, 620, 629, 
631-36, 638, 640, 641, 644-47, 649, 670, 674, 680, 682, 685, 690, 
691, 697, 709, 710, 726, 727, 731, 732, 746-51, 753, 754, 755, 760, 
763, 766, 777, 779, 782, 787-89, 799, 803.
---------------------------------------------------------------------------

    The Commission recognizes that its proposed method of calculation 
would have imposed significant delays on sellers and consumers under 
some limited circumstances. For example, a verification request 
received after 5 p.m. on a Tuesday would not be deemed verified until 9 
a.m. on Thursday. In addition, a request received after 5 p.m. on a 
Friday would not be deemed verified until 9 a.m. the following 
Tuesday--or at 9 a.m. the following Wednesday if Monday were a Federal 
holiday. Although the latter scenario would not occur frequently, such 
delay would have been significant.
    Accordingly, the Commission has clarified in the final Rule that 
the eight-hour verification period ends--and a seller may sell contact 
lenses--when eight business hours have elapsed. Thus, for example, if a 
prescriber receives a proper verification request before 9 a.m., the 
seller may ship a customer's order at 5:01 p.m. if the prescriber has 
not responded that the prescription is expired, inaccurate, or 
otherwise invalid. Under this approach, prescribers will have a 
reasonable opportunity to respond to verification requests, and 
consumers will obtain the benefits from expeditious verification.
    In addition, the Commission has clarified that the time period is 
calculated from the time the prescriber receives a proper verification 
request from a seller, rather than when the seller provides the request 
to the prescriber as stated in the proposed Rule.\47\ That is, if a 
prescriber receives a verification request during business hours (as 
defined in the final Rule), the eight-hour verification period begins 
immediately; if a prescriber receives a request during non-business 
hours, the eight hours begins at the start of the next business hour. 
This clarification is necessary to harmonize the definition of 
``business hour'' with section 4(d)(3) of the Act, which provides that 
a prescription is verified if the prescriber fails to communicate 
``within eight (8) business hours after receiving from the seller'' the 
information required to make a verification request.\48\
---------------------------------------------------------------------------

    \47\ The proposed Rule had stated that eight business hours 
would begin ``at the time that the seller provides the prescription 
verification request to the prescriber.'' 69 FR at 5441.
    \48\ 15 U.S.C. 7603(d).
---------------------------------------------------------------------------

d. Time Zone
    A number of prescribers, as well as national and state optometric 
associations, commented that the Rule should specify that business 
hours are calculated based on the prescriber's time zone, not the 
seller's.\49\ The Commission agrees that the Rule should make clear 
which time zone applies. Given that Congress intended to give 
prescribers eight business hours during which they are open to verify 
prescriptions,\50\ the Commission concludes that ``business hour'' 
should be determined based on the prescriber's time zone, and has 
revised the Rule accordingly.
---------------------------------------------------------------------------

    \49\ E.g., M. Spittler (Comment 158); Wheaton Eye 
Clinic (Comment 416); C.W. Kissling, O.D. (Comment 
452); E. Attaya (Comment 952); Pennsylvania 
Optometric Association (Comment 959); Olathe Family Vision 
(Comment 971); Kansas Optometric Association (Comment 
1153); Colorado Optometric Association (Comment 
1067); New Mexico Optometric Association (Comment 
1081); Kentucky Optometric Association (Comment 
1101); National Association of Optometrists and Opticians 
(Comment 1146); American Optometric Association (Comment 
1149); Ohio Optometric Association (Comment 1151); 
California Optometric Association (Comment 1158). Two other 
commenters more generally asked the Commission to specify which time 
zone applies. K. Poindexter (Comment 260); E. Lamp, O.D. 
(Comment 714).
    \50\ 15 U.S.C. 7603(d).
---------------------------------------------------------------------------

2. Definition of ``Commission'
    The proposed Rule defined ``Commission'' to mean the Federal Trade 
Commission.\51\ The Commission received no comments on this definition 
and adopts it, without modification, in the final Rule.
---------------------------------------------------------------------------

    \51\ See 69 FR at 5448.
---------------------------------------------------------------------------

3. Definition of ``Contact Lens''
    The Act does not define the term ``contact lens.'' In the NPRM, the 
Commission asked whether the Rule should define the term and, if so, 
whether the definition should include non-corrective (e.g., decorative) 
lenses.\52\
---------------------------------------------------------------------------

    \52\ 69 FR at 5447.
---------------------------------------------------------------------------

    The Commission received a number of comments on this issue. Most 
commenters recommended defining the term, and most urged the Commission 
to specifically include ``cosmetic,'' ``decorative,'' or ``non-
corrective'' lenses, or otherwise explicitly state that the Rule 
applies to all contact lenses.\53\ The primary reason stated was that 
both corrective and non-corrective lenses pose health risks to 
consumers and therefore a prescription should be required to obtain 
them. One commenter also stated that Congress did not draw any 
distinction in the Act between different types of lenses, and therefore 
the definition in the Rule should not.\54\
---------------------------------------------------------------------------

    \53\ K. Green (Comment 4); C. Smith (Comment 
6); M. Davis (Comment 8); M. Walker (Comment 
10); W. Lindahl (Comment 16); W. West (Comment 
126); Poindexter (Comment 260); Illinois 
Optometric Association (Comment 1005); Kansas Board of 
Examiners in Optometry (Comment 1007); American Optometric 
Association (Comment 1149); Kansas Optometric Association 
(Comment 1153); New Mexico Optometry Association (Comment 
1081); Ohio Optometric Association (Comment  
1151); California Optometric Association (Comment 1158).
    \54\ American Optometric Association (Comment 1149).
---------------------------------------------------------------------------

    Two commenters noted, however, that some cosmetic lenses currently 
are available without a prescription.\55\ To

[[Page 40487]]

avoid ambiguity about the Rule's applicability to such lenses, one of 
these commenters recommended that the Commission define ``contact 
lens'' as ``any contact lens for which state or federal law requires a 
prescription.'' \56\
---------------------------------------------------------------------------

    \55\ American Society for Cataract and Refractive Surgery 
(Comment 1148); Mercatus Center at George Mason University 
(Regulatory Studies Program) (Comment 1087).
    \56\ Mercatus Center at George Mason University (Regulatory 
Studies Program) (Comment 1087).
---------------------------------------------------------------------------

    The Act focuses on the release and verification of contact lens 
prescriptions. The Act also prohibits advertising that contact lenses 
``may be obtained without a prescription.'' \57\ The Commission thus 
concludes that Congress intended the Act and implementing Rule to cover 
only contact lenses for which a prescription is required. Accordingly, 
the Commission has decided to add the following definition to the Rule: 
``For purposes of the Rule, `contact lens' means any contact lens for 
which state or federal law requires a prescription.''
---------------------------------------------------------------------------

    \57\ 15 U.S.C. 7605.
---------------------------------------------------------------------------

4. Definition of ``Contact Lens Fitting''
    Section 11(1) of the Act defines a ``contact lens fitting'' as 
``the process that begins after an initial eye examination for contact 
lenses and ends when a successful fit has been achieved or, in the case 
of a renewal prescription, ends when the prescriber determines that no 
change in the existing prescription is required.'' \58\ The Act states 
that the fitting process ``may include--(a) an examination to determine 
lens specifications; (b) except in the case of a renewal of a contact 
lens prescription, an initial evaluation of the fit of the contact lens 
on the eye; and (c) medically necessary follow-up examinations.'' \59\ 
The definition of ``contact lens fitting'' in the proposed Rule was 
taken verbatim from the Act.\60\ For the reasons set forth below, the 
Commission adopts this definition without modification in the final 
Rule.
---------------------------------------------------------------------------

    \58\ Id. at 7610(1).
    \59\ Id.
    \60\ See 69 FR at 5448.
---------------------------------------------------------------------------

    A number of commenters suggested that the term ``medically 
necessary follow-up examinations'' be defined specifically in the final 
Rule.\61\ Based on the record, the Commission lacks the expertise to 
define this term; moreover, it seems unlikely that even medical 
professionals could list in advance all circumstances in which there 
are valid medical reasons for a follow-up examination. Accordingly, the 
Commission declines to define that term in the final Rule at this time. 
The Commission, however, expects prescribers to exercise sound 
professional judgment when determining if follow-up exams are 
``medically necessary'' based on appropriate and objective standards of 
medical care.
---------------------------------------------------------------------------

    \61\ Consumers Union (Comment 1139) (recommending that 
follow-up examinations must be medically indicated and occur within 
30 days of the original fitting exam); R. Weigner (Comment 
1118) (follow-up examination should be ``more strictly 
defined so it cannot extend indefinitely''); American Society for 
Cataract and Refractive Surgery (Comment 1148) (opposing a 
Commission-determined standard, but recommending the Rule expressly 
state ``as reasonably determined by the prescriber''); Illinois 
Optometric Association (Comment 1005) (seeking a broader 
definition such as ``medically necessary follow-up examinations and/
or sufficient follow up and lens parameter adjustment to minimize 
the risks of contact lens complications as much as clinically 
possible''); Dr. K. Poindexter (Comment 260).
    One trade association also requested a clarification that the 
initial evaluation includes giving a patient a pair of lenses to 
wear on a trial basis, and that the fitting is not complete until 
the prescriber settles on the final prescription. American Society 
for Cataract and Refractive Surgery (Comment 1148). The 
Commission believes that the proposed definition of ``contact lens 
fitting'' clearly and sufficiently indicates that a contact lens 
fitting may include an initial evaluation of the fit of the contact 
lens on the eye (except in the case of renewals) as well as any 
medically necessary follow-up exams.
---------------------------------------------------------------------------

5. Definition of ``Contact Lens Prescription''
    Section 11(3) of the Act defines a ``contact lens prescription'' as 
``a prescription, issued in accordance with State and Federal law, that 
contains sufficient information for the complete and accurate filling 
of a prescription for contact lenses, including the following: (a) The 
name of the patient; (b) the date of examination; (c) the issue date 
and expiration date of prescription; (d) the name, postal address, 
telephone number, and facsimile telephone number of prescriber; (e) the 
power, material or manufacturer or both of the prescribed contact lens; 
(f) the base curve or appropriate designation of the prescribed contact 
lens; (g) the diameter, when appropriate, of the prescribed contact 
lens; and (h) 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.'' \62\ The definition 
of ``contact lens prescription'' in the proposed Rule was taken 
verbatim from Section 11(3) of the Act.\63\ For the reasons set forth 
below, the Commission adopts the proposed definition without 
modification in the final Rule.
---------------------------------------------------------------------------

    \62\ 15 U.S.C. 7610(3).
    \63\ See 69 FR at 5488.
---------------------------------------------------------------------------

a. Number of Lenses Prescribed
    Several prescriber trade associations,\64\ one state optometry 
board,\65\ and numerous individual prescribers \66\ recommended that 
the Commission revise the definition to require the inclusion on the 
prescription of the number of lenses or refills allowed. Many of these 
commenters expressed concerned that the absence of such information 
would allow patients to circumvent the prescription expiration date by 
purchasing additional quantities of lenses before the prescription 
expires.\67\ One of these commenters pointed out that the Act 
contemplates that quantity limits are appropriate because it mandates 
that sellers include the quantity ordered in their verification 
requests.\68\
---------------------------------------------------------------------------

    \64\ American Optometric Association (Comment 1149); 
Illinois Optometric Association (Comment 1005); Kentucky 
Optometric Association (Comment 1101).
    \65\ Kansas Board of Examiners in Optometry (Comment 
1007).
    \66\ E.g., E. Attaya (Comment 952); G. Barker (Comment 
125); S. Carlson, O.D. (Comment 906); M. R. Carter 
(Comment 3); M. Dean (Comment 457); D. Deeds 
(Comment 13); K. Green (Comment 4); W. Lindahl 
(Comment 16); M. Palermo, O.D. (Comment 22); M. 
Walker (Comment 165); Your Family Eye Doctors, Inc. 
(Comment 705).
    \67\ E.g., Kansas Board of Examiners in Optometry (Comment 
1007); W. Lindahl (Comment 16).
    \68\ American Optometric Association (Comment 1149).
---------------------------------------------------------------------------

    Sellers, in contrast, noted that the Act does not provide for 
prescribers to limit the number of boxes or units dispensed so long as 
the prescription is current.\69\ The sellers further argued that such 
restrictions could be used to impose expiration dates shorter than 
those contemplated under the Act. Moreover, an academic ophthalmologist 
commented that allowing prescribers to limit the number of refills 
might encourage patients to overwear contact lenses in order to 
``stretch'' their prescriptions to the end of the expiration 
period.\70\ The same commenter noted that, if quantity limits are 
imposed, patients who tear or lose their lenses or who have to replace 
lenses more frequently may have prescriptions that run out before they 
expire. In addition, one seller contended that patients may choose to 
replace lenses more frequently than recommended by their prescriber, 
and that such potentially healthier choices could be precluded if 
prescriptions limit

[[Page 40488]]

the number of lenses that can be dispensed.\71\
---------------------------------------------------------------------------

    \69\ AC Lens (Comment 974); William F. Shughart, II, 
Ph.D., on behalf of 1-800-CONTACTS (Comment 975) .
    \70\ P.S. D'Arienzo, M.D. (Comment 1056).
    \71\ AC Lens (Comment 974).
---------------------------------------------------------------------------

    After reviewing the comments, the Commission has decided not to 
modify the definition of contact lens prescription to require the 
inclusion of the quantity of lenses or refills allowed. The Act does 
not require the inclusion of quantity information on the prescription. 
In addition, if the quantity of lenses is included on the prescription, 
then prescribers may use quantity limits to impose prescription 
expiration dates that are effectively shorter than the one-year period 
imposed under the Act. Moreover, it is not necessary to include the 
quantity of lenses on the prescription to limit patients' ability to 
circumvent the expiration date. Section 315.5(b) requires verification 
requests to contain the quantity of lenses ordered, and as discussed 
below in section 315.5(d), the quantity ordered may be a legitimate 
basis for a prescriber to treat a request for verification of a 
prescription as ``inaccurate.'' The verification process itself thus 
generally allows prescribers to prevent patients from ordering 
excessive contact lenses.
    The Commission recognizes that some State laws or regulations may 
require prescribers to include such information on the prescription. 
Prescribers in States without such requirements may also choose to 
include such information on the prescription.
    The Commission, however, emphasizes that prescribers may not use 
quantity limits to frustrate the prescription expiration requirements 
imposed by section 315.6 of the final Rule. The quantity of lenses or 
refills specified in the prescription must be sufficient to last 
through the prescription's expiration date, which typically will be one 
year after the issue date. If a lesser quantity of lenses or refills is 
specified in the prescription, the prescriber must have a legitimate 
medical reason for doing so, and the requirements imposed by section 
315.6(b) of the final Rule on writing a prescription for less than one 
year must be met.
b. Private Label Lenses
    A few sellers commented on the Rule provision regarding private 
label lenses.\72\ This provision requires prescriptions for private 
label contact lenses to identify ``the name of the manufacturer, trade 
name of the private label brand, and, if applicable, trade name of 
equivalent brand name.'' \73\ Two sellers recommended that the Rule be 
revised to require manufacturers of private label lenses to provide 
information to prescribers regarding all equivalent brands, so that 
this information can be included on the prescription.\74\ One of the 
sellers stated that prescribers and sellers may not know which private 
label lenses have equivalent brands, so there is currently no mechanism 
by which sellers and prescribers can comply with subsection (8) of the 
proposed definition.\75\ Nothing in the Act or its legislative history, 
however, indicates that Congress intended to require contact lens 
manufacturers to inform prescribers of brand names of equivalent 
lenses. Consequently, the Commission has concluded that imposing such 
disclosure requirements on manufacturers would exceed the mandate of 
the Act.
---------------------------------------------------------------------------

    \72\ Costco Wholesale Corporation (Comment 1061); AC 
Lens (Comment 974); 1-800 CONTACTS (Comment 1140).
    \73\ 69 FR at 5488.
    \74\ Costco Wholesale Corporation (Comment 1061); AC 
Lens (Comment 974).
    \75\ Costco Wholesale Corporation (Comment 1061).
---------------------------------------------------------------------------

    Another seller suggested that the definition be modified to require 
those who prescribe private label contact lenses to identify on the 
prescription the ``trade name of a brand name sold to alternative 
sellers.'' \76\ Section 11(3)(H) of the Act requires that prescriptions 
for private label contact lenses include the name of the manufacturer, 
the private label brand name, and, if applicable, the ``trade name of 
an equivalent brand name.'' \77\-\78\ Although the Act thus 
expressly requires that ``equivalent brand name'' contact lenses be 
identified in prescriptions for private label lenses, it does not 
require that such ``equivalent brand name'' contact lenses be sold to 
alternative sellers. The Commission has therefore concluded that 
requiring prescribers to identify the ``trade name of a brand name sold 
to alternative sellers'' would go beyond the requirements of the 
Act.\79\
---------------------------------------------------------------------------

    \76\ 1-800 CONTACTS (Comment 1140). This commenter was 
also concerned about ``doctor exclusive lenses,'' which it described 
as contact lenses sold by manufacturers only to eye care providers 
and for which there are no available substitutes sold to alternative 
sellers. The commenter suggested that the Rule require prescribers 
who prescribe such ``doctor exclusive lenses'' to specify on the 
prescription a brand name for lenses that are similar, but not 
identical, to the prescribed lenses, and are sold to alternative 
sellers. The Act requires disclosure only when lenses identical to 
the prescribed lenses are sold under different private label brand 
names. The imposition of a disclosure requirement for other lenses 
is beyond the mandate of the Act.
    \77\ \78\ 15 U.S.C. 7610(3)(H).
    \79\ In addition, one prescriber trade association recommended 
that subsection (8) of the definition be revised to state ``trade 
name of identical brand name'' rather than ``trade name of 
equivalent brand name'' to emphasize that prescription alteration is 
not allowed. Illinois Optometric Association (Comment 
1005). Because the phrase ``trade name of equivalent brand 
name'' was taken directly from the Act, and there is no evidence in 
the record indicating that the phrase is inappropriate, the 
Commission has decided not to make the requested change.
---------------------------------------------------------------------------

c. Other Suggested Additions
    A few prescribers recommended that a contact lens wearing schedule 
be required on the prescription.\80\ A contact lens wearing schedule 
outlines how often the contact lenses should be removed and/or 
replaced. After reviewing these comments, the Commission has determined 
that the record does not contain sufficient evidence to justify the 
imposition of such a requirement in the final Rule. The Commission 
notes, however, that the Rule does not prohibit a prescriber from 
including such information on the prescription.
---------------------------------------------------------------------------

    \80\ E.g., M. Walker (Comment 165); R. Carter (Comment 
3).
---------------------------------------------------------------------------

    One commenter suggested that the Commission modify the proposed 
definition to require prescribers to include an e-mail address on 
prescriptions for verification purposes, presumably to facilitate 
communications between sellers and prescribers.\81\ Other commenters 
recommended that an email address be allowed, but not required, on a 
contact lens prescription because some prescribers may not use e-
mail.\82\ One such commenter pointed out that e-mail addresses are 
likely to change frequently, particularly in rural areas.\83\ After 
reviewing these comments, the Commission has decided not to revise the 
Rule to require the inclusion of an e-mail address, because the record 
contains no evidence regarding the extent to which prescribers use e-
mail to communicate. Although not required, a prescriber may choose to 
include his or her e-mail address on a contact lens prescription, to 
facilitate efficient communication between prescribers and patients as 
well as between prescribers and sellers.
---------------------------------------------------------------------------

    \81\ R.Weigner (Comment 1118).
    \82\ American Society for Cataract and Refractive Surgery 
(Comment 1148); K. Poindexter (Comment 260); 
Illinois Optometric Association (Comment 1005).
    \83\ Illinois Optometric Association (Comment 1005).
---------------------------------------------------------------------------

    One prescribers' trade association recommended that the Rule 
expressly allow contact lens prescriptions to include language 
underscoring that there should be no substitutions.\84\ The

[[Page 40489]]

Act, however, permits substitution of identical contact lenses for 
private label lenses.\85\ Consequently, the Commission has concluded 
that this recommendation would be inconsistent with the Act.
---------------------------------------------------------------------------

    \84\ American Optometric Association (Comment 1149). A 
prescriber expressed a similar concern that contact lens sellers 
``notoriously switch patients into what they see as equal or 
identical contact lens [prescriptions]'' and added that ``this 
practice should be stopped.'' S. Wexler, O.D. (Comment 
375).
    \85\ Section 4(e) of the Act, 15 U.S.C. 7603(f).
---------------------------------------------------------------------------

6. Definition of ``Direct Communication''
    The proposed Rule defined ``direct communication'' to mean a 
``completed communication by telephone, facsimile, or electronic 
mail.'' \86\ In its NPRM, the Commission explained that, under this 
definition, direct communication by telephone would require reaching 
and speaking with the intended recipient, or leaving a voice message on 
the telephone answering machine of the intended recipient; and direct 
communication by facsimile or electronic mail would require that the 
intended recipient actually receive the facsimile or electronic mail 
message.\87\ For the reasons set forth below, the Commission adopts 
this definition without modification in the final Rule.
---------------------------------------------------------------------------

    \86\ 69 FR at 5448.
    \87\ See id. at 5441.
---------------------------------------------------------------------------

a. Automated Telephone Systems
    The Commission received a substantial number of comments objecting 
to sellers' use of automated telephone systems to convey verification 
requests to prescribers. Most of these commenters were individual 
prescribers or prescriber trade associations, a number of whom argued 
that automated requests do not constitute direct communication and 
should be expressly prohibited under the Rule.\88\ Some commenters 
bluntly stated that the automated systems currently in use simply 
``don't work.'' \89\ Other commenters explained that so-called 
``binary'' automated systems--which ask prescribers to press 1 to 
verify or press 2 if not willing to verify--are inadequate. Binary 
automated systems do not provide prescribers an option to correct any 
inaccuracy; require an immediate response and thus do not allow the 
prescriber eight business hours to verify; and do not provide the 
option of speaking with the seller.\90\
---------------------------------------------------------------------------

    \88\ E.g., American Optometric Association (Comment 
1149); Nebraska Optometric Association (Comment 
1083); Arizona Optometric Association (Comment 
1072); Arizona Medical Association (Comment 1130); 
Ohio Optometric Association (Comment  1151); Kansas 
Optometric Association (Comment 1153); Kentucky Optometric 
Association (Comment 1101); K. Driver, O.D. (Comment 
273); Wheaton Eye Clinic (Comment 416); S. Bryant, 
O.D. (Comment 1127); J. B. Rogers, O.D. (Comment 
1119); B. Oppenheim (Comment 1).
    \89\ E.g., Olathe Family Vision (Comment 971); Your 
Family Eye Doctors, Inc. (Comment 705); Drs. Odom and 
Coburn (Comment 958); see also A. Lee (Comment 
1096) (``automatic calling by [a] robot is worthless''); R. 
Garfield (Comment 19) (citing numerous problems with 
automated phone verification); M. Przybylowski (Comment 9) 
(same); S. Carpenter (Comment 182).
    \90\ E.g., Texas Ophthalmological Association (Comment 
1117); North Carolina State Optometric Society (Comment 
1074); Oklahoma Association of Optometric Physicians 
(Comment 1125); American Academy of Ophthalmology (Comment 
1057); Illinois Optometric Association (Comment 
1005).
---------------------------------------------------------------------------

    Other commenters stated that automated systems often malfunction 
\91\ or begin imparting information as soon as the prescriber's 
telephone answering system picks up (e.g., for after-hours calls), 
which frequently results in all or part of the message being cut off or 
not recorded at all.\92\ Two prescribers objected that automated 
verification systems are ``cumbersome'' and ``time-consuming'' for 
staff who must respond to the verification request in real time while 
patients are in their office waiting for service.\93\
---------------------------------------------------------------------------

    \91\ E.g., Ohio Optometric Association (Comment 1151); 
Oklahoma Association of Optometric Physicians (Comment 
1125).
    \92\ E.g., National Association of Optometrists and Opticians 
(Comment 1146); Colorado Optometric Association (Comment 
1067) (noting some recordings shut off automatically before 
the message is complete); Kansas Optometric Association (Comment 
1153) (noting that some optometrists' offices do not record 
incoming messages at all).
    \93\ J. Sawyer (Comment 814); D. Ball (Comment 
849).
---------------------------------------------------------------------------

    The Commission recognizes that automated telephone systems may 
create communication problems as described in the comments received. 
Nevertheless, we decline to revise the definition of ``direct 
communication'' to prohibit the use of automated telephone verification 
requests. The Act expressly authorizes sellers to send verification 
requests by telephone,\94\ which is commonly understood to include 
automated telephone systems. It would thus seem to be contrary to 
Congressional intent to prohibit the use of this technology.
---------------------------------------------------------------------------

    \94\ See 15 U.S.C. 7603(a)(2) (permitting prescription 
verification by ``direct communication''), 7603(g) (defining 
``direct communication'' to include communication by telephone).
---------------------------------------------------------------------------

    Nevertheless, the Commission emphasizes that calls from automated 
telephone systems must fully comply with all applicable Rule 
requirements. For example, any automated verification request must (1) 
provide complete verification request information as required under 
section 315.5(b), and this information must be either received by a 
person on the telephone or otherwise received in full (e.g., all of the 
requisite information left on a telephone answering machine), and (2) 
allow eight business hours for the prescriber to respond. If these and 
other applicable requirements are not met, the automated verification 
request is not valid.
    In addition, the Commission will continue to monitor whether full, 
valid requests for verification of a prescription are being made 
through the use of automated telephone systems. If evidence 
demonstrates that sellers are not making valid verification requests 
but are providing consumers with contact lenses despite deficient 
requests, the Commission may revisit this issue.
b. Technologies Used for ``Direct Communication''
    Other commenters argued that the Commission should alter the scope 
of technologies that may be used to achieve direct communication 
between sellers and prescribers. Some commenters urged the Commission 
to define ``direct communication'' more broadly than originally 
proposed. For example, one seller suggested the term include the 
existing technologies currently specified--facsimile, telephone, and e-
mail--plus any ``substantially equivalent communication technology,'' 
so as to specifically embrace future technologies.\95\ Other commenters 
sought a narrower definition that would permit verification only 
through a person-to-person telephone call; \96\ one commenter 
recommended that the Rule permit only fax and e-mail communication, and 
not telephone.\97\
---------------------------------------------------------------------------

    \95\ 1-800 CONTACTS (Comment 1140). See also Mercatus 
Center at George Mason University (Regulatory Studies Program) 
(Comment 1087) (suggesting more open-ended definition--such 
as adding ``or other electronic means''--rather than enumerating all 
permissible communication options).
    \96\ E.g., K. Poindexter (Comment 260) (arguing that 
communication by fax and e-mail are not workable because seller has 
no way to know when prescriber receives it and thus when the 
communication was ``completed''); M. Walker (Comment 10) 
(same); M. Davis (Comment 8) (same); Catherine Smith 
(Comment 6) (same); K. Green (Comment 4) (citing 
problems with fax--e.g., paper jam, no paper, no toner, memory 
failure--and e-mail--e.g. blocked by anti-spam software or by ISP); 
J. Maurillo (Comment 172) (suggesting that person-to-person 
call be followed by a faxed confirmation); H. Cerri, M.D. (Comment 
1129) (verification should occur by recorded telephone 
call).
    \97\ C.F. Ford, O.D. (Comment 969).
---------------------------------------------------------------------------

    The Act plainly states that ``direct communication'' includes 
communication by telephone, facsimile, or electronic mail.'' \98\ 
Accordingly, the

[[Page 40490]]

Commission cannot eliminate by rule any of the three specified methods. 
As for expanding the definition to specifically reference ``future'' or 
``substantially equivalent'' technology, Congress's use of the term 
``includes'' contemplates that additional methods of communication may 
develop that sellers and prescribers could use in the verification 
process. There is no evidence in the record, however, of specific 
additional technologies that sellers and prescribers currently use or 
are likely to use in the verification process. Moreover, the Commission 
cannot determine how the verification process would work, or how 
recordkeeping requirements would apply, with respect to as-yet-unknown 
technologies. If such other technologies develop, the Commission may 
consider revising the Rule to permit those technologies to be used in 
direct communication.
---------------------------------------------------------------------------

    \98\ 15 U.S.C. 7603(g).
---------------------------------------------------------------------------

c. ``Completed'' Communication by Telephone, Facsimile or Electronic 
Mail
    Commenters also asked the Commission to define or clarify when a 
``completed'' communication by telephone, facsimile or electronic mail 
has occurred. One Internet-based contact lens seller proposed an 
expansive definition that would include either (a) affirmative evidence 
that a communication was completed, (b) evidence that a fax or e-mail 
or substantially equivalent communication technology had been attempted 
twice, or (c) evidence that live telephone verification had been 
attempted.\99\ Another seller suggested that electronic confirmation of 
a successful facsimile transmission, or the absence of notification 
that an e-mail was undeliverable, should be sufficient evidence of 
completed communication by those means.\100\
---------------------------------------------------------------------------

    \99\ 1-800 CONTACTS (Comment 1140).
    \100\ AC Lens (Comment 974) (Rule should not require 
active acknowledgment of receipt by recipient, as that would be 
contrary to the Act's passive verification scheme). See also 
Mercatus Center at George Mason University (Regulatory Studies 
Program) (Comment 1087) (urging Commission not to define 
``completed'' communication too restrictively because the Act's 
intent appears to tolerate some errors, such as e-mails lost in 
cyberspace or a prescriber's fax machine running out of paper).
---------------------------------------------------------------------------

    A number of prescribers sought narrower definitions of 
``completed'' communications or more stringent requirements on sellers, 
such as the receipt of a confirmation of successful fax transmission 
and confirmation that someone was available in the prescriber's office 
within the eight-hour time period to respond.\101\ Similarly, one 
commenter sought a requirement that sellers call prescribers to verify 
that the fax or e-mail verification request was in fact received, if 
the prescriber does not respond within eight hours.\102\ One 
optometrist argued that the Rule requires that the prescriber must 
``receive'' the verification request, and the only way to ensure this 
is to require some type of receipt or positive response from the 
prescriber.\103\
---------------------------------------------------------------------------

    \101\ Staff (Comment 131). See also C. Lesko, M.D. FACS 
(Comment 960) (seller should have to verify that fax was 
actually sent to and received by the appropriate prescriber's 
office, so that consumers do not use fake prescriber names and fax 
numbers).
    \102\ American Society for Cataract and Refractive Surgery 
(Comment 1148) (but proposing that fax confirmation and no 
error e-mail notice (or notification that addressee has received 
and/or read an e-mail) would be sufficient evidence of completion 
for communications by prescriber to seller).
    \103\ E. Lamp, O.D. (Comment 714).
---------------------------------------------------------------------------

    The specific question of whether a message left on an answering 
machine or voicemail constitutes a ``completed'' communication 
generated a number of comments. Most of these comments--primarily from 
prescribers and one of their trade associations--argued that the Rule 
should not permit voice messages.\104\ These commenters stated, for 
example, that they often had difficulty transcribing the messages, thus 
increasing the potential for error,\105\ and that sellers should not be 
allowed to leave confidential patient information on an answering 
machine.\106\ Other commenters, however, favored allowing messages on 
answering machines.\107\ One commenter argued that allowing voicemail 
messages helps avoid extended ``phone tag,'' while another stated that 
prohibiting such messages would impose a significant burden on smaller 
sellers who are located in the Eastern time zone and are trying to 
communicate with offices of prescribers in Western time zones.\108\
---------------------------------------------------------------------------

    \104\ E.g., Kansas Board of Examiners in Optometry (Comment 
1007) (arguing seller has no way to know when prescriber 
receives message, and thus when eight-hour verification period 
begins and ends); C.F. Ford, O.D. (Comment 969); A.L. 
Warner (Comment 706); Wheaton Eye Clinic (Comment 
416); E. Lamp, O.D. (Comment 714).
    \105\ American Optometric Association (Comment 1149) 
(suggesting at a minimum that prescribers be allowed to opt out of 
telephone verification); E. Attaya (Comment 952) 
(recordings are confusing and at times impossible to understand). 
See also Drs. Odom and Coburn (Comment 958) (citing 
difficulties with answering machine messages).
    \106\ Staff (Comment 131).
    \107\ E.g., R. Weigner (Comment 1118); Wal-Mart Optical 
Division (Comment 1070) (arguing that it is reasonable to 
presume that prescribers listen to their messages).
    \108\ American Society of Cataract and Refractive Surgery 
(Comment 1148); AC Lens (Comment 974) (noting that 
message would include full information required by Act).
---------------------------------------------------------------------------

    The language of the Act does not specifically define when a 
seller's communication of verification information is completed. 
Legislative history is instructive on the issue of what constitutes a 
completed communication, however. In its Report, the House Committee 
made clear that it intended direct communication to mean ``a message 
[that] has been both sent and received.'' \109\
---------------------------------------------------------------------------

    \109\ H. Rep. No. 108-318, at 10 (2003).
---------------------------------------------------------------------------

    Having considered the comments, the Commission declines to further 
define what constitutes a ``completed'' communication in the Rule. 
However, the Commission confirms, as explained in the NPRM, that a 
communication is ``completed'' when all of the required information is 
received by the recipient. For example, direct communication by 
telephone would require reaching and speaking with the intended 
recipient, or clearly leaving a voice message on the telephone 
answering machine of the intended recipient setting forth all of the 
required information. Direct communication by facsimile or electronic 
mail similarly would require that the intended recipient receive the 
facsimile or electronic mail message. A facsimile confirmation will 
usually provide a sufficient basis to conclude that a facsimile 
communication was successfully received. E-mails are typically received 
almost instantaneously after they are sent, so confirmation that an e-
mail was sent will generally constitute a sufficient basis to conclude 
that the e-mail was received.\110\
---------------------------------------------------------------------------

    \110\ However, if the sender has reason to believe that an e-
mail was not transmitted instantly (e.g., receiving an electronic 
notification stating that the e-mail transmission was not 
successful) or that a facsimile was not transmitted, then the 
communication is not completed until it is actually received by the 
recipient.
---------------------------------------------------------------------------

    It is incumbent upon the party initiating the communication to use 
a method that enables the recipient to receive all the information 
being communicated, and the eight-business-hour verification period 
does not begin until such receipt occurs. Moreover, sellers must 
document the communications as provided in part 315.5(f) of the final 
Rule.
    The Commission also declines to impose additional requirements on 
sellers to confirm receipt of communications by prescribers. The Act 
reveals no indication that Congress intended to impose different 
standards when sellers communicate with prescribers than when 
prescribers communicate with sellers. The record

[[Page 40491]]

also does not provide sufficient evidence to warrant such a revision to 
the Rule.\111\
---------------------------------------------------------------------------

    \111\ The Commission also declines to allow the presumption of a 
``completed'' communication based merely on evidence that a fax or 
e-mail had been attempted twice, or evidence that live telephone 
verification had been attempted, as one commenter suggested. The Act 
requires that prescribers actually receive a verification request 
for a direct communication to occur.
---------------------------------------------------------------------------

7. Definition of ``Issue Date''
    Section 5(c) of the Act defines the ``issue date'' as ``the date on 
which the patient receives a copy of the prescription.'' \112\ The 
definition of ``issue date'' in the proposed Rule was taken verbatim 
from the Act.\113\ Under section 315.6 of the Rule, contact lens 
prescriptions may not expire less than one year after the ``issue 
date'' unless medically necessary.
---------------------------------------------------------------------------

    \112\ 15 U.S.C. 7604(c).
    \113\ See 69 FR at 5448.
---------------------------------------------------------------------------

    Several commenters suggested that the definition be modified to 
make clear that the ``issue date'' is the date on which the prescriber 
provides the patient with the prescription at the completion of the 
examination or fitting.\114\ Most of these commenters indicated that a 
prescriber giving an additional copy of a prescription to a patient at 
some later date should not constitute another ``issue date.'' If it 
did, the expiration date for the prescription could be extended one 
year from the new issue date.\115\
---------------------------------------------------------------------------

    \114\ American Optometric Association (Comment 1149); 
Dr. K. Poindexter (Comment 260); W. West, O.D. (Comment 
126); W. Barr, O.D. (Comment 1068); Arizona 
Optometric Association (Comment 1072) (suggesting that 
prescription expiration period begin when prescriber determines 
contact lens parameters); 1-800 CONTACTS (Comment 1140) 
(suggesting ``the date on which the patient, or any person 
designated to act on behalf of the patient, first receives a copy of 
the prescription'').
    \115\ A few commenters suggested that the ``issue date'' be 
defined as the date the prescriber writes the prescription or as 
some earlier date. E.g., American Society for Cataract and 
Refractive Surgery (Comment 1148) (suggesting the date the 
prescriber writes the prescription); R. Weigner (Comment 
1118) (suggesting the actual date on which the prescription 
was written, and recommending that pre- or post-dating of 
prescriptions be expressly disallowed); S.J. St. Marie, O.D. 
(Comment 1121) (suggesting that the issue date be earlier 
than the release date when the prescriber requires the patient to 
use the lenses on a diagnostic trial basis). Section 5(c) of the Act 
mandates the ``patient receipt'' standard contained in the proposed 
Rule. Consequently, the Commission declines to implement the 
requested changes in the final Rule.
---------------------------------------------------------------------------

    Section 2(a)(1) of the Act requires a prescriber to provide a copy 
of the prescription to the patient when the prescriber ``completes a 
contact lens fitting.'' \116\ The Commission does not believe Congress 
intended to allow patients to extend the prescription issue date--and 
thereby extend the prescription expiration date--by obtaining 
additional copies of prescriptions from prescribers subsequent to the 
completion of the contact lens fitting. The Commission has therefore 
concluded that the definition of ``issue date'' should be revised to 
clarify that it is ``the date on which the patient receives a copy of 
the prescription at the completion of a contact lens fitting.''
---------------------------------------------------------------------------

    \116\ 15 U.S.C. 7601(a)(1).
---------------------------------------------------------------------------

8. Definition of ``Ophthalmic Goods''
    The proposed Rule defined ``ophthalmic goods'' to mean contact 
lenses, eyeglasses, or any component of eyeglasses.\117\ The Commission 
received no comments on this definition, and adopts it without 
modification in the final Rule.
---------------------------------------------------------------------------

    \117\ See 69 FR at 5449.
---------------------------------------------------------------------------

9. Definition of ``Ophthalmic Services''
    The proposed Rule defined ``ophthalmic services'' to mean the 
measuring, fitting, and adjusting of ophthalmic goods subsequent to an 
eye examination.\118\ The Commission received no comments on this 
definition, and adopts it without modification in the final Rule.
---------------------------------------------------------------------------

    \118\ See 69 FR at 5449.
---------------------------------------------------------------------------

10. Definition of ``Prescriber''
    The Commission's proposed Rule defined ``prescriber'' to mean, with 
respect to contact lens prescriptions, 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.\119\ This definition 
tracked the language of the Act verbatim.\120\
---------------------------------------------------------------------------

    \119\ See 69 FR at 5449.
    \120\ 15 U.S.C. 7610(2).
---------------------------------------------------------------------------

    The Commission received a number of comments on this proposed 
definition, most of which related to the application of this definition 
to licensed opticians currently permitted under State law to fit 
contact lenses. According to the commenters, these opticians--sometimes 
referred to as ``dispensing opticians''--may perform a contact lens 
fitting based on an eyeglass prescription that contains a notation from 
the prescriber that the patient is ``OK for contact lenses'' or similar 
language.\121\
---------------------------------------------------------------------------

    \121\ E.g., K. Green (Comment 4); D. Acosta (Comment 
14).
---------------------------------------------------------------------------

    Several commenters, including the Opticians Association of America, 
urged the Commission to make clear in the Rule that licensed dispensing 
opticians must release contact lens prescriptions to their patients at 
the end of a contact lens fitting.\122\ The California Association of 
Dispensing Opticians noted that California law currently requires 
dispensing opticians to release prescriptions to patients.\123\
---------------------------------------------------------------------------

    \122\ K. Green (Comment 4); Opticians Association of 
America (Comment 1059); California Association of 
Dispensing Opticians (Comment 1104).
    \123\ Comment 1104.
---------------------------------------------------------------------------

    Having reviewed the comments, the Commission has concluded that, to 
the extent dispensing opticians are authorized under state law to issue 
prescriptions, they are ``prescribers'' under the Act and are required 
to release contact lens prescriptions at the completion of a contact 
lens fitting just like other prescribers. The Commission believes that 
such a requirement is both consistent with, and necessary to fully 
effectuate, Congress's intent to provide consumers with their 
prescriptions. Accordingly, the Commission's final Rule defines 
``prescriber'' to include opticians authorized or permitted under state 
law to perform contact lens fitting services who also are permitted to 
issue contact lens prescriptions.\124\
---------------------------------------------------------------------------

    \124\ One commenter also recommended that the Commission revise 
the definition of ``contact lens prescription'' to include ``an 
eyeglass prescription and the notation `OK for contact lenses' or 
similar language on the prescription provided there are no 
contraindications for contact lenses.'' D. Acosta (Comment 
14). The Commission believes the revised definition of 
``prescriber'' adequately addresses this comment.
    Another commenter recommended that the Rule prohibit anyone from 
fitting and dispensing contact lenses unless that person is properly 
licensed to write a prescription. Kentucky Optometric Association 
(Comment 1101). See also Ohio Optometric Association 
(Comment 1151) (urging Commission to state in the Rule that 
contact lens ``fitting'' may be initiated and directed only by a 
licensed optometrist or ophthalmologist). The question of who is 
authorized to fit contact lenses is beyond the scope of the Act; it 
is a question that is properly resolved as a matter of State law.
---------------------------------------------------------------------------

11. Definition of ``Private Label Contact Lenses''
    Section 315.2 of the proposed Rule defines ``private label contact 
lenses'' as ``contact lenses that are sold under the label of a seller 
where the contact lenses are identical to lenses made by the same 
manufacturer but sold under the labels of other sellers.'' \125\ This 
proposed definition was derived from Section 4(f) of the Act.\126\ The 
Commission received no comments on the proposed definition, and 
therefore adopts it without modification in the final Rule.
---------------------------------------------------------------------------

    \125\ 69 FR at 5448.
    \126\ 15 U.S.C. 7603(f).

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

[[Page 40492]]

C. Section 315.3: Availability of Contact Lens Prescriptions to 
Patients

1. 315.3(a)--In general
a. The Prescription Release Requirement
    Section 2(a)(1) of the Act requires that ``when a prescriber 
completes a contact lens fitting, the prescriber--(1) whether or not 
requested by the patient, shall provide a copy of the contact lens 
prescription to the patient.'' \127\ Section 315.3(a)(1) of the 
proposed Rule tracks the language of the Act verbatim.\128\ For the 
reasons set forth below, the Commission adopts this provision without 
modification in the final Rule.
---------------------------------------------------------------------------

    \127\ 15 U.S.C. 7601(a)(1).
    \128\ See 69 FR at 5449.
---------------------------------------------------------------------------

    As an initial matter, the Commission notes that thousands of 
consumers submitted comments expressing strong support for the Act and 
proposed Rule's prescription release requirement.\129\ Many of these 
commenters felt strongly that the contact lens prescription belongs to 
the consumer.\130\ Others stated that contact lens consumers should 
have the same prescription release rights as eyeglasses wearers.\131\
---------------------------------------------------------------------------

    \129\ E.g., Consumers (Comments 28, 29, 30, 
31, 32, 33, 34, 36, 38, 40, 43, 44, 45, 48, 49, 51, 54, 56, 57, 59, 
60, 64, 69, 71, 72, 73, 74, 75, 78, 79, 82, 83, 84, 87, 89, 90, 91, 
92, 93, 94, 96, 97, 98, 100, 102, 105, 106, 107, 108, 109, 110, 111, 
114, 115, 118, 119, 120, 121, 122, 123, 124, 132, 147, 152, 153, 
155, 159, 163, 166, 169, 170, 171, 173, 174, 176, 178, 179, 181, 
183, 184, 186, 187, 189, 190, 191, 192, 195, 198, 199, 201, 202, 
203, 204, 205, 206, 207, 209, 210, 212, 213, 215, 217, 218, 219, 
220, 222, 223, 226, 227, 228, 229, 230, 231, 232, 234, 235, 238, 
240, 241, 242, 245, 246, 247, 248, 249, 250, 253, 255, 256, 257, 
258, 259, 262, 263, 264, 265, 267, 272, 276, 281, 287, 289, 290, 
292, 308, 315, 326, 327, 337, 342, 349, 358, 364, 380, 441, 451, 
455, 465, 514, 519, 521, 539, 624, 653, 698, 726, 740, 761, 762, 
765, 772, 775, 776, 777, 790, 793, 795, 798, 802, 806, 807, 808, 
809, 813, 816, 820, 824, 825, 830, 836, 837, 841, 845, 848, 853, 
859, 871, 873, 875, 878, 879, 880, 881, 892, 895, 897, 898, 922, 
923, 936, 955, 967, 994, 1008, 1069, 1098, 1099, 1131, 1186, 1215, 
1216, 1220, 1222, 1235).
    \130\ E.g., Consumers [Comment 1201 (``I have 
the undeniable right to have a copy of my Rx for my records, whether 
I choose to do anything with it or not''); Comment 1221 
(``my prescription belongs to me, not the doctor to hold for 
ransom'')].
    \131\ E.g., Consumers (Comments 27, 43, 45, 
65, 66, 70, 85, 86, 101, 105, 160, 209, 222, 225, 246, 255, 259, 
266, 274, 293, 295, 301, 303, 310, 314, 321, 336, 344, 370, 384, 
396, 402, 414, 432, 449, 493, 496, 497, 652, 656, 664, 693, 772, 
798, 805, 806, 833, 873, 881, 895, 898, 921, 939, 950, 956, 988, 
1004, 1182, 1193, 1194, 1214, 1216, 1220, 1226).
---------------------------------------------------------------------------

    The State Attorneys General expressed hope that the prescription 
release requirement will accelerate the frequency with which patients 
provide an actual copy of the prescription to a non-prescribing 
seller.\132\ The State Attorneys General noted that elimination of the 
need for verification under such circumstances will allow the seller to 
ship the lenses immediately. House Judiciary Committee Chairman 
Sensenbrenner, a co-sponsor of the Act, pointed out that the intent of 
the Act is ``to allow consumers to receive their contact lens 
prescriptions so they can easily shop around to buy their lenses from 
any number of suppliers.'' \133\
---------------------------------------------------------------------------

    \132\ State Attorneys General (Comments 1114, 
1176).
    \133\ Hon. F. James Sensenbrenner, Jr., U.S. House of Rep. 
(Comment 1246).
---------------------------------------------------------------------------

    A few prescribers expressed concern about the health implications 
of the immediate prescription release obligation imposed by section 
315.3(a)(1).\134\ Section 2(a)(1) of the Act,\135\ however, expressly 
requires prescribers to release contact lens prescriptions to patients 
when the ``prescriber completes a contact lens fitting,'' not at some 
later date.
---------------------------------------------------------------------------

    \134\ A. Richards (Comment 2) (recommending that 
release not be required until the patient has safely worn the 
contact lenses for 6 months, and noting that it often takes several 
weeks before corneal problems are manifested); D. Pao (Comment 
139) (noting that the proper prescription is typically not 
decided at the initial fitting visit, but normally, at the follow-up 
visit in 1-2 weeks, and in most cases by 4-6 weeks). One prescriber 
was concerned that the release obligation is not in the best 
interest of the consumer because contact lens sellers have no 
knowledge of preventative care. A.D. Adins, O.D. (Comment 
1133).
    \135\ 15 U.S.C. 7601(a)(1).
---------------------------------------------------------------------------

    Several commenters expressed the concern that prescribers may 
pressure consumers to purchase contact lenses from them if, prior to 
releasing the written prescription, prescribers can try to persuade 
consumers to make such a purchase. These commenters urge the Commission 
to require that prescribers release the written prescription 
immediately following the contact lens fitting and before attempting to 
sell and dispense contact lenses.\136\ The Act does not impose any such 
restriction on prescribers. Moreover, because the Act and the Rule 
provide that prescribers may not require the patient to purchase 
contact lenses from them or from another person, see 15 U.S.C. 7601(b) 
and section 315.3(b)(1) of the Rule, consumers already have protection 
against pressure to purchase from the prescriber. The Commission 
therefore has determined not to require that prescribers release the 
written prescription immediately following the contact lens fitting and 
before attempting to sell and dispense contact lenses.
---------------------------------------------------------------------------

    \136\ 1-800 CONTACTS (Comment 1140); William F. 
Shughart, II, Ph.D., on behalf of 1-800-CONTACTS (Comment 
975); The Independent Women's Forum (Comment 
1236); Americans for Prosperity (Comment 1145). 
See also discussion of section 315.3(b)(2), infra, concerning the 
ability of prescribers to offer a bundled package of an eye 
examination and contact lenses.
---------------------------------------------------------------------------

    A few commenters suggested that the prescriber be given the option 
to not release the prescription or to release it for ``informational 
purposes only'' if the patient has purchased a full year's supply of 
contact lenses at the time of the eye examination.\137\ 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, it is not included in the final Rule.
---------------------------------------------------------------------------

    \137\ North Carolina State Optometric Society (Comment 
1074); M. Walker (Comment 165).
---------------------------------------------------------------------------

    Two commenters recommended that the prescription release obligation 
be limited to one release per patient.\138\ Section 2(a)(1) of the Act 
mandates the release of the patient's contact lens prescription to the 
patient at the completion of the contact lens fitting.\139\ The Act 
neither requires prescribers to, nor prohibits them from, releasing 
additional copies of the prescription. The Commission declines to 
require or prohibit by Rule the release of additional copies of the 
prescription.
---------------------------------------------------------------------------

    \138\ Nebraska Optometric Association (Comment 1083); 
Dr. K. Poindexter (Comment 260).
    \139\ 15 U.S.C. 7601(a)(1).
---------------------------------------------------------------------------

    Finally, a number of prescribers suggested that custom-designed 
soft lenses and rigid gas permeable lenses be exempt from the release 
requirement because such lenses require significant interaction between 
the prescriber and the manufacturer as well as proper follow-up and 
medical management.\140\ In contrast, one seller recommended that the 
Commission not make an exception for rigid gas permeable and other 
specialized made-to-order lenses, because it supplies such lenses to 
consumers more conveniently and at significant savings compared to 
prescribers.\141\ Section 2(a)(1) of the Act mandates simply that the 
prescriber ``provide to the patient a copy of the contact lens 
prescription.'' \142\ The Act thus does not permit the Commission by 
rule to grant an exception to the release requirement for custom-
designed soft and rigid gas permeable lenses. Moreover, the record 
indicates that some sellers (other than prescribers) can supply such 
lenses to consumers. Consequently, the creation of an exception to the 
release requirement for custom-designed soft and rigid gas

[[Page 40493]]

permeable lenses would be inconsistent with the Act's goal of 
meaningful prescription portability and increased consumer choice. The 
final Rule accordingly includes no such exception.
---------------------------------------------------------------------------

    \140\ American Society for Cataract and Refractive Surgery 
(Comment 1148); Colorado Optometric Association (Comment 
1067); California State Board of Optometry (Comment 
21) (requesting exception for rigid gas permeable, bitoric 
gas permeable, bifocal gas permeable, keratoconus and custom 
lenses); Wheaton Eye Clinic (Comment 416); S. Carlson, O.D. 
(Comment 906); G. Lozada (Comment  1063).
    \141\ AC Lens (Comment 974).
    \142\ 15 U.S.C. 7601(a)(1).
---------------------------------------------------------------------------

b. The Prescription Verification Requirement
    Section 2(a)(2) of the Act requires that, when a prescriber 
completes a contact lens fitting, the prescriber ``shall, as directed 
by any person designated to act on behalf of the patient, provide or 
verify the contact lens prescription by electronic or other means.'' 
\143\ Section 315.3(a)(2) of the proposed Rule tracks the language of 
the Act verbatim.\144\ For the reasons set forth below, the Commission 
adopts the proposed provision without modification in the final Rule.
---------------------------------------------------------------------------

    \143\ 15 U.S.C. 7601(a)(2).
    \144\ See 69 FR at 5449.
---------------------------------------------------------------------------

    Prescriber trade associations recommended that sellers be required 
to obtain written proof of authority to act on the patient's 
behalf.\145\ In contrast, one seller urged the Commission to clarify in 
the final Rule that sellers or other agents are not required to have a 
written agency agreement to act on a patient's behalf, because the Act 
allows for verification by telephone.\146\
---------------------------------------------------------------------------

    \145\ American Society for Cataract and Refractive Surgery 
(Comment 1148); New York State Optometric Association 
(Comment 1073); Florida Board of Optometry (Comment 
1100). Two of these commenters also expressed concern about 
state professional responsibility rules that may prohibit the 
release of patient information without written consent. New York 
State Optometric Association (Comment 1073); Florida Board 
of Optometry (Comment 1100).
    \146\ 1-800 CONTACTS (Comment 1140).
---------------------------------------------------------------------------

    After reviewing the comments, the Commission has not included in 
the final Rule the requirement that sellers present written proof that 
they are agents of consumers. Section 4(g) of the Act expressly 
includes communications by telephone as a means of ``direct 
communication'' that sellers can use to submit verification information 
to prescribers.\147\ The Act therefore clearly contemplates that the 
entire verification process can be conducted by telephone, which 
implicitly precludes requiring written proof that a seller is an agent 
of a consumer.\148\
---------------------------------------------------------------------------

    \147\ 15 U.S.C. 7603(g).
    \148\ Moreover, the consumer must provide his or her 
prescription information to the seller to begin the verification 
process, which itself is probative as to whether the seller is the 
consumer's agent.
---------------------------------------------------------------------------

    A few prescribers commented that the Rule does not state how many 
times a prescriber is required to verify a prescription.\149\ These 
commenters were concerned that prescribers must bear the burden of 
verification requests from multiple sellers, even though the patient 
has already received a copy of the prescription. The Act clearly 
imposes two separate obligations upon prescribers at the completion of 
a contact lens fitting. First, prescribers must provide a copy of the 
prescription to the patient.\150\ Second, prescribers must provide or 
verify the prescription as directed by any person designated to act on 
behalf of the patient.\151\ Consequently, the Act itself mandates that 
prescribers may have to respond to verification requests from multiple 
sellers.
---------------------------------------------------------------------------

    \149\ Staff (Comment 131); E. Attaya (Comment 
952).
    \150\ 15 U.S.C. 7603(a)(1).
    \151\ 15 U.S.C. 7603(a)(2).
---------------------------------------------------------------------------

2. 315.3(b)--Limitations
    Section 315.3(b) of the proposed Rule would prohibit prescribers 
from imposing certain conditions on the release or verification of a 
contact lens prescription.\152\ Specifically, a prescriber may not (1) 
require a patient to purchase contact lenses from the prescriber or 
from another person, (2) require payment in addition to, or as part of, 
the fee for an eye examination, fitting, and evaluation, or (3) sign a 
waiver or release of liability, as a condition of release or 
verification.\153\ The proposed Rule tracked the Act almost 
verbatim,\154\ and, as discussed below, the Commission adopts this 
provision without modification in the final Rule.
---------------------------------------------------------------------------

    \152\ See 69 FR at 5449.
    \153\ Id.
    \154\ 15 U.S.C. 7601(b).
---------------------------------------------------------------------------

a. Section 315.3(b)(1)
    The Commission received numerous comments relating to the 
prohibition against prescribers' requiring the purchase of contact 
lenses as a condition of prescription release. Most of these commenters 
urged the agency to add an exception in the Rule for ``specialty'' or 
``custom'' lenses--such as rigid gas permeable and toric lenses--which 
are manufactured specifically for an individual patient and for which 
manufacturers do not provide free trial pairs.\155\ According to these 
commenters, such lenses include lenses to treat kerataconus, high and 
irregular astigmatic lenses, and lenses used for orthokeratology. A 
prescriber must purchase these lenses from the manufacturer--at a 
typical cost in the range of $150 per pair--to conduct the fitting 
process, and the prescriber may not be able to return the lenses to the 
manufacturer.\156\ The commenters contend that prescribers should be 
permitted to require their patients to pay for these lenses prior to 
releasing the contact lens prescription. Otherwise, the prescriber 
would have to absorb the cost of these lenses if a patient takes the 
prescription and fills it elsewhere.\157\ One trade association 
estimated that such lenses account for a very small percentage of 
contact lens sales--less than 5% for its members--and that non-
prescribers (i.e., mail order and mass merchant sellers) do not 
typically sell these lenses anyway.\158\
---------------------------------------------------------------------------

    \155\ E.g., D. Hughes (Comment 712); National 
Association of Optometrists and Opticians (Comment 1146); 
American Optometric Association (Comment 1149); Illinois 
Optometric Association (Comment 1005); W. Lindahl (Comment 
7); K. Green (Comment 4); J. Owen (Comment 
154). See also Texas Ophthalmological Association (Comment 
1117) (prescribers should be able to charge for lenses 
necessary to complete the fitting process); California Optometric 
Association (Comment 1158) (same); Arizona Optometric 
Association (Comment 1072) (Rule should address specialty 
lenses); Arizona Medical Association (Comment 1130) (same).
    \156\ National Association of Optometrists and Opticians 
(Comment 1146) (historically patients have been required to 
pay for these lenses in conjunction with the fitting, typically in 
the range of $150 per pair).
    \157\ Notably, these commenters did not object to releasing the 
prescription to the patient at the completion of the fitting 
process. E.g., American Optometric Association (Comment 
1149).
    \158\ National Association of Optometrists and Opticians 
(Comment 1146).
---------------------------------------------------------------------------

    The Act expressly prohibits prescribers from conditioning 
prescription release on the purchase of contact lenses. The Commission 
thus does not have the authority to grant an exception to that 
prohibition. Moreover, the record indicates that some sellers (other 
than prescribers) can supply custom-designed soft and rigid gas 
permeable lenses to consumers. Consequently, the creation of an 
exception for custom-designed soft and rigid gas permeable lenses would 
be inconsistent with the Act's goal of meaningful prescription 
portability and increased consumer choice. The final Rule accordingly 
includes no such exception.
    Nevertheless, as the commenters explained, ``speciality'' or 
custom-made lenses are sometimes necessary to complete the fitting 
process. To the extent these lenses are necessary to complete the 
fitting process, prescribers may charge patients for such lenses as 
part of the cost of the fitting process,\159\ and as such may condition 
the release of a contact lens prescription on payment of the fitting 
fee.
---------------------------------------------------------------------------

    \159\ One commenter suggested that the cost of such lenses be 
incorporated into the contact lens fitting fee. A.L. Warner (Comment 
706). Another commenter advised against ``bundling'' the 
cost of the lenses into the fitting fee itself, because the prices 
of such lenses vary. Texas Ophthalmological Association (Comment 
1117).

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

[[Page 40494]]

b. Section 315.3(b)(2)
    This provision of the proposed Rule prohibits prescribers from 
requiring payment in addition to, or as part of, the fee for an eye 
examination, fitting, and evaluation, as a condition of prescription 
release or verification. The Commission received few comments on this 
provision and adopts it without modification in the final Rule.
    One commenter recommended that prescribers be allowed to charge a 
reasonable fee for providing verification services to their 
competition.\160\ The Act expressly prohibits such a fee. Another 
commenter sought clarification that prescribers may bill patients for a 
contact lens fitting and medically necessary follow-up exams, in 
addition to a regular eye exam.\161\ Section 315.3(b)(2) of the Rule 
expressly permits prescribers to charge for these services, consistent 
with section 315.4, as a condition of releasing a contact lens 
prescription.
---------------------------------------------------------------------------

    \160\ D.S. Dwyer, M.D. (Comment 1071).
    \161\ S. Wagner (Comment 1107); see also Illinois 
Optometric Association (Comment 1005) (seeking 
clarification that a prescriber may require a comprehensive eye exam 
before performing a contact lens fitting and releasing the contact 
lens prescription). S. Wagner (Comment 1107) also asked the 
Commission to clarify that prescribers may charge a fee for 
verifying a contact lens fitting originally performed by another 
prescriber--i.e., to confirm, for a new patient, that a previous fit 
is still valid and correct. If the service described by this 
commenter effectively constitutes a ``contact lens fitting,'' the 
prescriber may charge the consumer for this service as it would for 
any contact lens fitting.
---------------------------------------------------------------------------

    Another commenter asked the Commission to clarify that the Rule 
prohibits prescribers from requiring payment for ``service agreements'' 
or similar follow-up exams beyond the contact lens fitting.\162\ 
According to this commenter, a survey conducted in Texas in October 
2000 showed that prescribers charged customers for a ``service 
agreement'' covering follow-up visits, which tie the patient to that 
prescriber's office. If such follow-up visits are not part of the 
contact lens fitting process--i.e., medically necessary--then the Act 
expressly prohibits requiring payment for them as a condition of 
prescription release or verification.
---------------------------------------------------------------------------

    \162\ Consumers Union (Comment 1139).
---------------------------------------------------------------------------

    On a similar point, a few commenters raised the issue of whether 
section 315.3(b) permits ``bundling'' practices by prescribers. One 
commenter asked the Commission to clarify that this section does not 
prohibit prescribers from offering a ``package deal'' on an exam and 
the initial set of diagnostic lenses used to establish proper fit, 
medical suitability for contact lens wear, etc.\163\ This commenter 
argued that practitioners should be able to compete with other contact 
lens providers by offering services in a bundled package, so long as 
they do not charge an extra fee for providing the prescription.
---------------------------------------------------------------------------

    \163\ American Academy of Ophthalmology (Comment 1057).
---------------------------------------------------------------------------

    Other commenters complained about the practice of bundling.\164\ 
For example, one contact lens seller expressed concern that section 
315.3(b) permits bundling and therefore allows prescribers to coerce 
consumers into buying contact lenses from them, before releasing the 
contact lens prescription.\165\
    The Act does not prohibit a prescriber from offering a bundled 
package of an eye examination and contact lenses, provided that 
consumers have the option to purchase the eye examination separately 
and still receive their prescription. The Commission thus clarifies 
that bundling of the eye examination and contact lenses is not a per se 
violation of the Act or the final Rule.
---------------------------------------------------------------------------

    \164\ E.g., Consumers Union (Comment 1139).
    \165\1-800 CONTACTS (Comment 1140).
---------------------------------------------------------------------------

    In its NPRM, the Commission specifically asked for comment about 
whether prescribers itemize charges and fees in a manner that 
distinguishes the amount the patient is paying for an eye examination, 
fitting, and evaluation from the amount he or she is paying for contact 
lenses.\166\ One commenter indicated that a patient's receipt typically 
itemizes the charges into accepted insurance codes, and suggested that 
no further itemization is necessary.\167\ Another commenter reported 
that prescribers commonly use package deals as means of avoiding 
itemizing charges and fees, and suggested that the Rule require 
itemization of all charges and fees presented to the patient for 
payment at the end of a contact lens fitting.\168\ The Commission 
concludes that the record does not contain sufficient evidence to 
warrant a requirement that prescribers itemize their charges on a 
patient's bill.
---------------------------------------------------------------------------

    \166\ 69 FR at 5447.
    \167\ Illinois Optometric Association (Comment 1005).
    \168\ Consumers Union (Comment 1139).
---------------------------------------------------------------------------

    Finally, one commenter asked the Commission to prohibit additional 
conduct by prescribers that undermines prescription portability and the 
intent of the Act.\169\ For example, this commenter recommended that 
the Rule prohibit prescribers from discussing the purchase of contact 
lenses prior to releasing the consumer's prescription. The commenter 
also asked that the Rule require prescribers to inform consumers in 
writing, before the fitting process begins, of their right under the 
Act to receive their prescription. The Act does not address such 
prescriber conduct, and the Commission has determined not to 
incorporate any restrictions on such conduct into the final Rule.\170\
---------------------------------------------------------------------------

    \169\ 1-800 CONTACTS (Comment  1140).
    \170\ The same commenter also recommended that the Commission 
add a provision to the Rule prohibiting prescribers from using a 
seller's verification request to interfere with a pending contact 
lens sale. See id. The Commission believes that adding such a 
provision would exceed the mandate of the Act.
---------------------------------------------------------------------------

c. Section 315.3(b)(3)
    This provision of the proposed Rule prohibited prescribers from 
requiring a patient to sign a waiver or release as a condition of 
releasing or verifying a prescription.\171\ The Commission received no 
comments on this provision, and adopts it without modification in the 
final Rule.
---------------------------------------------------------------------------

    \171\ See 69 FR at 5449.
---------------------------------------------------------------------------

D. Section 315.4: Limits on Requiring Immediate Payment

    Section 315.4 of the proposed Rule states that a ``prescriber may 
require payment of fees for an eye examination, fitting, and evaluation 
before the release of a contact lens prescription, but only if the 
prescriber requires immediate payment in the case of an examination 
that reveals no requirement for ophthalmic goods.'' \172\ The provision 
further states that ``for purposes of the preceding sentence, 
presentation of proof of insurance coverage for that service shall be 
deemed to be a payment.'' \173\ The language in the proposed Rule 
tracks section 3 of the Act verbatim.\174\ For the reasons set forth 
below, the Commission adopts the proposed provision without 
modification in the final Rule.
---------------------------------------------------------------------------

    \172\ Id.
    \173\ Id.
    \174\ See 15 U.S.C. 7602.
---------------------------------------------------------------------------

    One prescribers' trade association stated that some of its members 
have misinterpreted this provision as prohibiting them from requiring 
payment of fees for an eye exam, fitting and evaluation before the 
release of a contact lens prescription.\175\ The Commission believes 
that the language of the proposed Rule is clear that requiring payment 
of fees for an eye exam, fitting and evaluation before the release of a 
contact lens prescription is permissible, but only if the prescriber 
also requires immediate payment in the case of an examination that 
reveals no

[[Page 40495]]

need for contact lenses or other ophthalmic goods.
---------------------------------------------------------------------------

    \175\ American Society for Cataract and Refractive Surgery 
(Comment 1148).
---------------------------------------------------------------------------

    Another prescribers' trade association asked the Commission to 
clarify that insurance coverage must be ``current'' and ``valid'' to 
ensure that patients do not attempt to defraud providers.\171\ A few 
commenters also asked the Commission to clarify that this provision of 
the Rule does not require a prescriber to accept as payment proof of 
insurance from an insurance plan in which the prescriber does not 
participate.\172\ In response, the Commission notes that the Act and 
the proposed Rule require that prescribers accept ``proof of insurance 
coverage'' as a form of payment. Clearly, to be a form of payment, the 
policy must cover the patient, be current, and be accepted by the 
prescriber. The Commission does not believe that any changes to the 
proposed Rule are needed to address the meaning of ``proof of insurance 
coverage.''\173\ Regulating insurance plans or their discount policies 
is beyond the scope of the Act.
---------------------------------------------------------------------------

    \171\ American Academy of Ophthalmology (Comment 1057).
    \172\ American Academy of Ophthalmology (Comment 1057); 
American Society for Cataract and Refractive Surgery (Comment 
1148); K. Green (Comment 4).
    \173\ One seller noted that some insurance plans provide 
discounts on lens purchases only if the patient purchases lenses 
from the same prescriber who provided the exam, and recommended that 
the Rule prohibit such practices in insurance or pricing policies. 
1-800 CONTACTS (Comment 1140).
---------------------------------------------------------------------------

E. Section 315.5: Prescriber Verification

1. 315.5(a)--Prescription Requirement
    Section 315.5(a) of the proposed Rule stated that a ``seller may 
sell contact lenses only in accordance with a contact lens prescription 
for the patient that is: (1) presented to the seller by the patient or 
prescriber directly or by facsimile; or (2) verified by direct 
communication.''\174\ This provision was taken verbatim from the 
Act.\175\ For the reasons set forth below, the Commission retains the 
same language in the final Rule.
---------------------------------------------------------------------------

    \174\ 69 FR at 5449.
    \175\ See 5 U.S.C. 7603(a).
---------------------------------------------------------------------------

a. Use of Copies
    A number of individual prescribers and state optometric 
associations recommended that the Rule be revised to require the seller 
to obtain the original prescription and prohibit the use of 
copies.\176\ These commenters expressed concern that patients may use 
copies of the prescription to circumvent either the prescription 
expiration period or the number of refills allowed. One seller, in 
contrast, asked the Commission to clarify that the seller is not 
required to have the original prescription to sell contact lenses.\177\ 
The Commission notes that section 4(a)(1) of the Act states expressly 
that a prescription may be presented to a seller ``directly or by 
facsimile.''\178\ A requirement that the seller obtain the original 
prescription would directly conflict with the phrase ``by facsimile'' 
in the statute. The Commission has therefore decided not to revise the 
Rule to require the seller to obtain the original prescription.
---------------------------------------------------------------------------

    \176\ Illinois Optometric Association (Comment 1005); 
Colorado Optometric Association (Comment 1067); Nebraska 
Optometric Association (Comment 1083); M. Palermo (Comment 
22); M. Dean (Comment 148); J. Barnes (Comment 
239); D. Hughes (Comment 712); S. Carlson, O.D. 
(Comment 906); D.S. Dwyer, M.D. (Comment 1071); 
J.L.Walters, O.D. (Comment 1109); S. Wagner (Comment 
1107).
    \177\ Wal-Mart Optical Division (Comment 1070).
    \178\ 15 U.S.C. 7603(a)(1).
---------------------------------------------------------------------------

b. Presentation of Prescriptions ``Directly or by Facsimile''
    A few commenters requested that the Commission broadly interpret 
the phrase ``directly or by facsimile'' in Section 4(a)(1) of the Act 
\179\ and section 315.5(a)(1) of the Rule. One seller suggested that 
the Rule expressly permit prescription information to be provided to 
the seller in person or by telephone, facsimile, electronic mail or a 
substantially equivalent future technology.\180\ The State Attorneys 
General commented that a patient should be able to deliver a digital 
image of a prescription (i.e., a scanned copy) directly to the seller 
via electronic mail.\181\
    The Commission has concluded that a patient or a prescriber may 
present the prescription to a seller in person, by mail, by facsimile, 
or through a digital image of the prescription that is sent via 
electronic mail.\182\ All of these communication mechanisms allow the 
seller to view either the original or an exact copy of the prescription 
that was written by the prescriber. Consequently, these communication 
mechanisms allow the patient or prescriber to present the prescription 
``directly or by facsimile'' to the seller under section 4(a)(1) of the 
Act and section 315.5(a)(1) of the Rule.
---------------------------------------------------------------------------

    \179\ 15 U.S.C. 7603(a)(1).
    \180\ 1-800 CONTACTS (Comment 1140).
    \181\ State Attorneys General (Comments 1114 
and 1176).
    \182\ One definition of ``facsimile'' is ``an exact copy.'' 
Merriam-Webster New Collegiate Dictionary 410 (1977). The Commission 
has concluded that a digital image of a prescription that is sent 
via electronic mail is ``an exact copy'' of the actual prescription, 
and therefore meets the ``directly or by facsimile'' standard set 
forth in section 4(a)(1) of the Act.
---------------------------------------------------------------------------

    Furthermore, the Commission has concluded that the provision of 
prescription information from the consumer to the seller by telephone 
or by e-mail (other than an e-mail containing a digital image of the 
prescription, as discussed above) does not meet the ``directly or by 
facsimile'' standard imposed by section 4(a)(1) of the Act.\183\ 
Telephone or e-mail communications are not expressly referenced in 
section 4(a)(1) of the Act, which addresses direct presentation 
requirements. In contrast, Section 4(g) of the Act states that a direct 
communication for verification purposes can be sent by ``telephone, 
facsimile or electronic mail.''\184\ Thus, Congress expressly allowed 
telephone and e-mail communications for verification purposes in 
section 4(g) of the Act, but did not similarly allow telephone and e-
mail communications for direct presentation purposes in section 4(a)(1) 
of the Act. Unlike the verification process, the direct presentation 
process may occur without the prescriber's involvement. Accordingly, 
the Act imposes a heightened level of scrutiny by requiring the seller 
to obtain the prescription ``directly or by facsimile.'' Consequently, 
if the patient reads the prescription information to the seller on the 
telephone or provides prescription information (as opposed to a digital 
image of the prescription) to the seller via e-mail or other electronic 
means, the prescription must be verified pursuant to section 315.5(d) 
of the Rule before the seller may supply lenses to the patient.
---------------------------------------------------------------------------

    \183\ The Commission's Rule is not intended to prohibit 
prescribers from using such mechanisms to issue contact lens 
prescriptions or orders to the extent authorized by other applicable 
law, however. See, e.g., 21 CFR 801.109(a)(2).
    \184\ See 15 U.S.C. 7603(g).
---------------------------------------------------------------------------

    The Commission has further decided not to include ``substantially 
equivalent future technologies'' within the scope of acceptable direct 
presentation mechanisms. Section 4(a)(1) of the Act does not expressly 
reference or contemplate future technologies, and the Commission is not 
aware of other technologies which meet the statutory standard. The 
Commission therefore declines to include future technologies that do 
not involve an exact copy of the prescription within the scope of 
acceptable direct presentation mechanisms at this time.
c. Delegation of Verification Obligations
    A few commenters recommended that the Rule be revised to provide 
prescribers with the ability to delegate

[[Page 40496]]

their verification obligations to specific individuals in their 
offices.\185\ The Commission declines to make the requested revision, 
and notes that neither the Act nor the Rule prohibits a prescriber from 
delegating the authority to respond to verification requests. The 
prescriber, however, remains responsible for ensuring that such staff 
members acting on his or her behalf comply with the Act and the Rule.
---------------------------------------------------------------------------

    \185\ E.g., Wal-Mart Optical Division (Comment 1070); 
American Society for Cataract and Refractive Surgery (Comment 
1148).
---------------------------------------------------------------------------

2. 315.5(b)--Information for Verification
    Section 315.5(b) of the proposed Rule sets forth the information 
that a seller must provide the prescriber through direct communication 
when the seller is seeking to verify a contact lens prescription.\186\ 
The proposed Rule required the seller to provide the prescriber with 
the following specific information: (1) The patient's full name and 
address; (2) the contact lens power, manufacturer, base curve or 
appropriate designation, and diameter when appropriate; (3) the 
quantity of lenses ordered; (4) the date of patient request; (5) the 
date and time of verification request; (6) the name of a contact person 
at the seller's company, including facsimile and telephone 
numbers.\187\ This provision of the proposed Rule was taken verbatim 
from section 4(c) of the Act.\188\
---------------------------------------------------------------------------

    \186\ See 69 FR at 5449.
    \187\ Id.
    \188\ 15 U.S.C. 7603(c).
---------------------------------------------------------------------------

a. Saturday Business Hours
    As discussed above, the Commission has modified the definition of 
``business hour'' in section 315.2 of the final Rule to ``include, at 
the seller's option, a prescriber's regular business hours on 
Saturdays, provided that the seller has actual knowledge of these 
hours.'' To facilitate the use of Saturday business hours, the 
Commission has revised section 315.5(b) of the final Rule to require 
sellers who opt to count such hours to state the prescriber's Saturday 
business hours in the verification request. Specifically, section 
315.5(b)(7) of the final Rule provides that ``if the seller opts to 
include the prescriber's regular business hours on Saturdays as 
``business hours'' for purposes of paragraph (c)(3) of this section,'' 
the verification request must include ``a clear statement of the 
prescriber's regular Saturday business hours.'' This information must 
be included in the verification request to alert the prescriber in case 
the seller is relying upon inaccurate information regarding the 
prescriber's regular Saturday business hours.\189\
---------------------------------------------------------------------------

    \189\ One seller recommended that sellers be required to include 
this type of information in verification requests. 1-800 CONTACTS 
(Comment 1140).
---------------------------------------------------------------------------

b. Format of Required Information
    Numerous commenters requested that the Commission either revise the 
Rule to require a standard verification request form or publish a model 
verification request form.\190\ The Commission has decided not to 
modify the Rule to require the use of a standard verification form. 
Each seller thus retains flexibility to develop the best form for its 
verification requests. Nevertheless, the Commission emphasizes that any 
verification form used must provide prescribers with all of the 
required prescription verification information and should also provide 
prescribers with sufficient opportunity (e.g., space on a form) to 
indicate that a particular prescription is expired, not the 
prescriber's patient, inaccurate, or otherwise invalid.\191\
---------------------------------------------------------------------------

    \190\ American Optometric Association (Comment 1149) 
(requesting model form); North Carolina State Optometric Society 
(Comment 1074); Oklahoma Association of Optometric 
Physicians (Comment 1125); Kansas Optometric Association 
(Comment 1153); Nebraska Optometric Association (Comment 
1083); D. Ball (Comment 849); M. Spittler (Comment 
158); New Mexico Optometric Assoc (Comment  1081); 
Kentucky Optometric Association (Comment 1101); Arizona 
Optometric Association (Comment 1072); Ohio Optometric 
Association (Comment  1151); K. Driver, O.D., Optometrist, 
P.A. (Comment 273); Olathe Family Vision (Comment 
971); S. Bryant, O.D. (Comment 1127).
    \191\ Prescribers and prescribers' trade associations have 
submitted comments indicating that sellers' current verification 
response forms do not contain an ``expired'' option or do not 
provide options fitting typical situations. E.g., Wisconsin 
Optometric Association (Comment 1086); D. Tabak (Comment 
23); M. Spittler (Comment 158); Dr. G.S. Leekha 
(Comment 24).
---------------------------------------------------------------------------

    A number of prescriber groups and individual prescribers submitted 
comments expressing concern that verification requests from sellers 
often do not contain required information, including the date and time 
of the request.\192\ Inclusion of such information on verification 
requests is central to the Rule's effective operation. The Commission 
emphasizes that the sale of contact lenses based on a verification 
request which does not contain all of the required information 
constitutes a Rule violation.
---------------------------------------------------------------------------

    \192\ American Optometric Association (Comment 1149); 
Colorado Optometric Association (Comment 1067); Staff 
(Comment 131); Your Family Eye Doctors, Inc. (Comment 
705); D. Hughes (Comment 712).
---------------------------------------------------------------------------

c. Additional Information in Verification Requests
    One prescriber trade association and an individual prescriber 
suggested that the verification request include additional information, 
such as the patient's telephone number and the patient's date of birth, 
which prescribers can use to search their records for the patient's 
file and to ensure that verification requests for individuals with the 
same name and same address do not create confusion.\193\ However, the 
commenters did not provide any evidence suggesting that the 
verification information required by section 315.5(b) of the proposed 
Rule would be insufficient to allow prescribers to search their patient 
files. Moreover, the commenters did not provide evidence regarding the 
frequency with which the ``same name, same address'' problem actually 
arises. Absent such evidence, the Commission declines to implement the 
requested change.
---------------------------------------------------------------------------

    \193\ National Association of Optometrists and Opticians 
(Comment 1146)(telephone number and date of birth); C.W. 
Kissling, O.D. (Comment 452) (date of birth).
---------------------------------------------------------------------------

    A State optometry association requested that the verification 
request contain the prescription's expiration date as well as the 
number of refills prescribed.\194\ Regarding the prescription 
expiration date, the Commission notes that prescribers should have this 
information because they issued the prescription and specified any 
expiration date of less than one year. Indeed, section 4(e) of the Act 
clearly places the burden on the prescriber to notify the seller if a 
prescription is expired.\195\ With respect to the number of refills 
prescribed, the Commission notes that the Act does not require contact 
lens prescriptions to include such information. Moreover, there is no 
reason to believe or evidence to suggest that a seller who is 
attempting to verify a prescription would necessarily have information 
as to the number of refills prescribed.\196\ For these reasons, the 
Commission declines to impose the requested changes.
---------------------------------------------------------------------------

    \194\ New York State Optometric Association (Comment 
1073). This commenter also suggested that the verification 
request include the number of refills requested. In response, the 
Commission notes that section 315.5(b)(3) requires the seller to 
list the quantity of lenses ordered on the verification request.
    \195\ 15 U.S.C. 7603(e).
    \196\ For example, a seller would not have this information if 
the consumer had used a different seller in the past to refill a 
prescription.
---------------------------------------------------------------------------

    Another state optometric association recommended that the seller be 
required to provide its e-mail address on the

[[Page 40497]]

verification form.\197\ In response, the Commission notes that the Act 
allows the use of e-mail for direct communications between sellers and 
prescribers. Nothing in the Act, however, forces either sellers or 
prescribers to use e-mail as a means of communicating. Consequently, 
because sellers are not required to accept responses to verification 
requests by e-mail, the Commission declines to require that the e-mail 
address of sellers be included on the verification form.
---------------------------------------------------------------------------

    \197\ California Optometric Association (Comment 1158).
---------------------------------------------------------------------------

    A few prescribers requested that the seller be required to verify 
or confirm that the prescriber who is being asked to verify the 
prescription is the prescriber who fitted the contact lenses in 
question.\198\ Otherwise, these commenters stated, a verification 
request that is sent to the wrong prescriber may be filled via passive 
verification because the prescriber neglects to respond to it. The 
Commission declines to implement the requested change because 
prescribers have the ability to respond that such verification requests 
are ``invalid'' under section 315.5(d) of the Rule. In addition, a 
verification request sent to the wrong prescriber does not conform with 
the requirements of the Act and section 315.5(b) of the Rule, and thus 
does not commence the eight-business-hour verification period.
---------------------------------------------------------------------------

    \198\ Smith/Eye Care of Ellensburg (Comment 12); G. 
Barker (Comment 125).
---------------------------------------------------------------------------

d. Contact Person at the Seller's Company
    Regarding the requirement in section 315.5(b)(6) of the Rule that 
the verification request include the name of a contact person at the 
seller's company, one prescribers' trade association commented that the 
person whose name is provided should be accessible to the prescriber 
and actually be handling the verification request.\199\ This provision 
of the Rule is intended to ensure that the prescriber is able to reach 
a responsible person at the seller's company rather than requiring that 
the prescriber be able to reach the specific person who is handling the 
verification request. The Commission thus agrees that the seller's 
listed contact person or, if that contact person is unavailable, an 
alternate person who is familiar with the verification request and is 
authorized to respond to the prescriber, must be reasonably accessible 
to the prescriber. However, the person whose name is provided on the 
verification form need not personally handle the verification request 
because such a requirement would be impractical.
---------------------------------------------------------------------------

    \199\ National Association of Optometrists and Opticians 
(Comment 1146).
---------------------------------------------------------------------------

    In comparison, one seller recommended that the contact name 
disclosure requirement in section 315.5(b)(6) be eliminated because the 
verification process already anticipates that the prescriber has a 
means of direct communication with the seller.\200\ The Commission 
declines to implement the requested change because the contact name 
disclosure requirement stems directly from section 4(c)(6) of the Act 
and the evidence in the record contains insufficient evidence to 
justify its elimination.
---------------------------------------------------------------------------

    \200\ Costco Wholesale Corporation (Comment 1061).
---------------------------------------------------------------------------

e. Selection of Communication Mechanism
    A few State optometric associations recommended that prescribers be 
allowed to determine the communication mechanism that sellers must use 
to submit a verification request to the prescriber (i.e., by telephone, 
fax or online).\201\ Section 4(g) of the Act expressly defines ``direct 
communication'' as including three different communication mechanisms 
that sellers may use: telephone, facsimile or electronic mail.\202\ The 
Act therefore does not permit prescribers to limit the communications 
mechanisms sellers may use to submit verification requests.\203\
---------------------------------------------------------------------------

    \201\ Kansas Optometric Association (Comment 1153); New 
Mexico Optometric Association (Comment 1081); Ohio 
Optometric Association (Comment  1151).
    \202\ 15 U.S.C. 7603(g).
    \203\ Nevertheless, nothing in the Act prohibits prescribers 
from informing sellers of their preferred mode of communication and 
nothing prohibits sellers from accommodating such requests.
---------------------------------------------------------------------------

3. 315.5(c)--Verification Events
    Section 315.5(c) of the proposed Rule states that a ``prescription 
is verified under paragraph (a)(2) of this section only if one of the 
following occurs: (1) the prescriber confirms the prescription is 
accurate by direct communication with the seller; (2) the prescriber 
informs the seller through direct communication that the prescription 
is inaccurate and provides the accurate prescription; or (3) the 
prescriber fails to communicate with the seller within eight (8) 
business hours after receiving from the seller the information 
described in paragraph (b) of this section.''\204\ This provision was 
derived from section 4(d) of the Act.\205\ For the reasons discussed 
below, the Commission adopts this provision without modification in the 
final Rule.
---------------------------------------------------------------------------

    \204\ 69 FR at 5449.
    \205\ See 15 U.S.C. 7603(d).
---------------------------------------------------------------------------

    Many prescribers either opposed or expressed significant concern 
about the passive verification system imposed by this section of the 
Rule.\206\ A few prescribers' trade associations also expressed 
significant concern about the use of a passive verification system in 
connection with a restricted medical device such as contact 
lenses.\207\ Because Congress has decided to impose a passive 
verification system through the Act, whether to adopt a passive 
verification system is not at issue in this rulemaking proceeding.
---------------------------------------------------------------------------

    \206\ J. Rubin (Comment 699); N. Silverstein, M.D. and 
R. Silverstein, M.D. (Comment 930); J. Owen (Comment 
154); Dr. J. Pingel (Comment 962); C.F. Ford, O.D. 
(Comment  969); S. Renner, O.D. (Comment 850); 
J.L.Walters, O.D. (Comment 1109); Jackson & Baalman 
(Comment 1084); D. D'Alessandro (Comment 1138); 
M.Turner, O.D. (Comment 1106); A. Lee (Comment 
1096); R. Purnell (Comment 1075); D.S. Dwyer, M.D. 
(Comment 1071); E. Goodlaw (Comment 18); M.Turner, 
O.D. (Comment 1058) (recommending that personal, non-
automated call or mail from seller be required if seller does not 
hear from the provider to confirm that the provider received the 
verification request).
    \207\ AAO (Comment 1057); American Society for Cataract 
and Refractive Surgery (Comment 1148); Wisconsin Optometric 
Association (Comment  1086).
---------------------------------------------------------------------------

a. The Start of the Prescription Verification Period
    A few prescribers' trade associations requested that the Commission 
clarify that, for purposes of section 315.5(c)(3), ``eight business 
hours'' begins when the prescriber receives a complete verification 
request from the seller.\208\ In contrast, one seller argued that if a 
prescriber receives an incomplete verification request, the prescriber 
should be required to treat the request as an ``inaccurate'' one under 
section 315.5(d) of the Rule and should be required to provide the 
seller with corrected information within eight business hours.\209\ 
Another seller commented that, as long as the verification request 
provides the prescriber sufficient information to locate the patient's 
record, the Rule should explicitly require the prescriber to provide 
the seller with the missing information from the prescriber's 
records.\210\
---------------------------------------------------------------------------

    \208\ American Optometric Association (Comment 1149); 
National Association of Optometrists and Opticians (Comment 
1146).
    \209\ Wal-Mart Optical Division (Comment 1070).
    \210\ 1-800 CONTACTS (Comment 1140).
---------------------------------------------------------------------------

    After reviewing these comments, the Commission has concluded that 
the prescription verification period begins when the prescriber 
receives a complete verification request. Section 4(d)(3) of the Act 
states clearly that a prescription

[[Page 40498]]

is verified only if the prescriber fails to communicate with the seller 
within eight business hours ``after receiving from the seller the 
information'' required to be provided by the Act.\211\ Thus, the eight-
business-hour period to verify only begins to run when the seller 
provides all of the required information to the prescriber.
---------------------------------------------------------------------------

    \211\ 15 U.S.C. 7603(d)(3).
---------------------------------------------------------------------------

    The Rule does not expressly require prescribers to notify sellers 
of incomplete requests. If the seller is not informed that a 
verification request is incomplete, however, a sale based on an 
expired, inaccurate or otherwise invalid prescription may occur after 
eight business hours. Because this may pose health risks to patients, 
the Commission encourages prescribers to inform sellers if they receive 
incomplete verification requests. In addition, the Commission notes 
that the Rule does not require prescribers to complete incomplete 
verification requests, but does not prohibit prescribers from doing so.
b. The Length of the Prescription Verification Period
    Section 4(d)(3) of the Act states that the prescription 
verification period is ``8 business hours or a similar time as defined 
by the Federal Trade Commission.'' \212\ The Act therefore authorizes 
the Commission to impose a prescription verification period of either 
``eight business hours'' or a ``similar time.'' Section 315.5(c)(3) of 
the proposed Rule contained an ``eight business hour'' prescription 
verification period.\213\ For the reasons set forth below, the 
Commission retains this provision in the final Rule and adds a 
requirement that, during the eight-business-hour period, sellers 
provide a ``reasonable opportunity'' for prescribers to communicate 
with sellers regarding verification requests.
---------------------------------------------------------------------------

    \212\ 15 U.S.C. 7603(d)(3).
    \213\ See 69 FR at 5449.
---------------------------------------------------------------------------

    Many commenters specifically addressed the length of the 
prescription verification period. For example, one seller indicated 
that the prescription verification period contained in section 
315.5(c)(3) of the proposed Rule of eight business hours is too long, 
and recommended shortening it to five hours from the time the seller 
makes the verification request, and to two hours if a live agent of the 
seller is able to communicate with a live agent of the prescriber by 
telephone.\214\ This commenter pointed out that California's 
prescription verification period (the earlier of 24 hours or 2 p.m. the 
next business day) is shorter than the verification period in the 
proposed Rule, and problems have not been reported in that State.
---------------------------------------------------------------------------

    \214\ 1-800 CONTACTS (Comment 1140).
---------------------------------------------------------------------------

    In addition, numerous consumers voiced their support for little or 
no delay in the shipping of contact lenses.\215\ These consumers 
explained that their busy lives require the ease and convenience of 
immediate shipping.\216\ A number of the consumers pointed out that 
quick or overnight shipments are especially important in emergency 
situations if contact lenses have been lost or torn.\217\ Many 
consumers also commented that they oppose a delay period that prevents 
them from ordering contact lenses from their preferred sources.\218\
---------------------------------------------------------------------------

    \215\ E.g., Comments 135, 136, 137, 138, 141, 142, 143, 
144, 145, 146, 481, 575, 583, 596, 597, 623, 738.
    \216\ E.g., Comments 144, 145, 385, 386, 409, 410, 419, 
423, 424, 425, 427, 430, 438, 439, 442, 443, 445, 446, 450, 454, 
456, 466, 467, 468, 471, 473, 474, 477, 479, 480, 484, 489, 532, 
533, 536, 548, 550, 554, 557, 558, 560, 562, 565, 567, 569, 570, 
579, 587, 589, 590, 592, 595, 598, 600, 601, 606, 609, 610, 611, 
612, 613, 625, 626, 628, 629, 632, 633, 634, 641, 642, 649, 650, 
652, 654, 655, 658, 659, 661, 662, 663, 672, 673, 675, 676, 678, 
679, 680, 681, 685, 690, 693, 694, 695, 697, 701, 719, 759, 777, 
786, 791, 809, 810, 826, 834, 845, 852, 871, 873, 877, 881, 882, 
883, 885, 892, 895, 905, 907, 908, 909, 915, 916, 924, 927, 949, 
953, 981, 986, 988, 1065, 1082, 1110, 1169, 1214, 1215, 1216, 1220, 
1222, 1223, 1224, 1225, 1226, 1227, 1229, 1230, 1234.
    \217\ E.g., Comments 140, 146, 388, 389, 390, 391, 393, 
415, 421, 428, 433, 434, 444, 458, 460, 461, 475, 482, 526, 535, 
541, 543, 545, 546, 564, 568, 578, 580, 581, 582, 585, 586, 591, 
593, 594, 599, 621, 627, 628, 648, 688, 728, 731, 746, 749, 753, 
782, 873, 888, 979, 1020, 1226.
    \218\ E.g., Comments 142, 143, 431, 463, 555, 571, 602, 
603, 604, 605, 616, 617, 620, 629, 631, 632, 633, 634, 635, 636, 
638, 640, 641, 644, 645, 646, 647, 649, 670, 674, 680, 682, 685, 
690, 691, 697, 709, 710, 726, 727, 731, 732, 746, 747, 748, 749, 
750, 751, 753, 754, 755, 760, 763, 766, 777, 779, 782, 787, 788, 
789, 799, 803, 825, 832, 835, 857, 858, 862, 866, 889, 901, 904, 
911, 921, 957, 970, 979, 996, 1000, 1012, 1015, 1016, 1018, 1019, 
1020, 1022, 1023, 1024, 1025, 1026, 1027, 1028, 1029, 1030, 1031, 
1032, 1033, 1034, 1035, 1036, 1037, 1039, 1040, 1043, 1044, 1046, 
1048, 1051, 1052, 1089, 1099, 1103, 1111, 1170, 1172, 1177, 1198, 
1206, 1207.
---------------------------------------------------------------------------

    In contrast, numerous prescriber groups and individual prescribers 
argued that the prescription verification period in the proposed Rule 
should be extended because it is too short to account for prescribers' 
busy schedules, illness, multiple location practices, vacations, 
professional conferences, and/or other absences from the office.\219\
---------------------------------------------------------------------------

    \219\ American Optometric Association (Comment 1149) 
(proposing a minimum of 12 business hours); Association of 
Regulatory Boards of Optometry (Comment 1154); Texas 
Optometric Association (Comment 977) (24 hours or actual 
prescriber business hours); American Society for Cataract and 
Refractive Surgery (Comment 1148); Illinois Optometric 
Association (Comment 1005) (48 hours); North Carolina State 
Optometric Society (Comment 1074) (24 or 16 business 
hours); E. Attaya (Comment 952); R. Scharfman, M.D. 
(Comment 890) (either more than an eight-hour response time 
or require seller to have secure 24-hour accessible means for 
receiving prescriber responses); Slusher (Comment 15) (16 
hours); R. Graham (Comment 162); A. Henley (Comment 
151); Wheaton Eye Clinic (Comment 416) (3 days); 
Morgantown Eye Associates, PLLC (Comment 925) (72 hours); 
Poindexter (Comment 260) (3 business days); K. Green 
(Comment 4) (six working days); S. Carpenter (Comment 
182); B. Athwal (Comment 188) (one month); T. Vail 
(Comment 211); A.D. Dorfman, M.D. (Comment 304); 
S. Wexler, O.D. (Comment 375) (one day or three days); C. 
Lesko, M.D., FACS (Comment 960); D. Emrich, O.D. (Comment 
973) (48 hours); Your Family Eye Doctors, Inc. (Comment 
705) ( 24 hours); B.L.Whitesell, O.D. (Comment 
1115); G. Lozada (Comment 1063) (24 hours, 
excluding weekends and holidays and making provisions for docs who 
are ill or out of town); O. Merdiuszew (Comment 1055); R. 
Purnell (Comment 1075); D.S. Dwyer, M.D. (Comment 
1071); Jackson & Baalman (Comment 1084).
---------------------------------------------------------------------------

    After reviewing the comments, the Commission has decided to retain 
the ``eight business hour'' standard in the final Rule. The ``eight 
business hour'' standard was taken directly from the Act, and the 
Commission has concluded that there is insufficient evidence in the 
record to justify a modification of the statutory standard.
    The Commission recognizes that any verification period requires 
patients to wait to receive their contact lenses from non-prescriber 
sources. However, Congress expressly required the Commission to impose 
a verification period of ``eight business hours or a similar time'' in 
Section 4(d)(3) of the Act.
    The Commission has decided not to implement a verification period 
shorter than the ``eight business hour'' period contained in the 
proposed Rule. The California standard, which is cited by one proponent 
of a shorter verification period, involves a verification period that 
may be as long as 24 hours or as short as approximately five business 
hours. The California experience therefore does not support the 
imposition of a blanket five-hour verification period, and, for the 
reasons discussed in detail above in the definition of ``business 
hour'' under section 315.2 of the Rule, the Commission has decided not 
to adopt the California approach. In addition, the Commission notes 
that the record contains no evidence to support the two-hour 
verification period proposed for situations in which a live agent of 
the seller is able to contact a live agent of the buyer. There is no 
reason to believe that a prescriber will be able (or should be 
required) to respond to a verification request more quickly simply 
because someone in the prescriber's office is able to answer the 
telephone when it rings.

[[Page 40499]]

    Moreover, as noted above, any alternative verification period must 
be ``similar'' to the eight-business-hour period contained in the 
Act.\220\ The commenter's proposed five-hour/two-hour standard would 
result in a verification period which is significantly shorter than the 
eight-business-hour period contained in the Act. Consequently, the 
Commission has concluded that the commenter's suggested verification 
period is not sufficiently ``similar'' to the eight-business-hour 
period contained in the Act to warrant adoption.
---------------------------------------------------------------------------

    \220\ See 15 U.S.C. 7603(d)(3).
---------------------------------------------------------------------------

    The Commission also declines to implement a prescription 
verification period longer than ``eight business hours'' because the 
evidence in the record does not support such a change. As noted above 
in the discussion of the definition of ``business hours'' under section 
315.2 of the Rule, survey evidence indicates that most prescribers' 
offices are open at least eight hours a day from Monday to Friday.\221\ 
In addition, under the final Rule, Saturday hours will not count as 
part of the prescription verification period for those prescribers who 
are not regularly open for business on Saturdays. Several prescribers 
commented that a longer verification period would reduce their 
compliance burden under the Rule,\222\ but they did not provide data 
demonstrating that prescribers will not be able to comply with the 
eight-business-hour verification period.
---------------------------------------------------------------------------

    \221\ 1-800 CONTACTS, Inc. (Comment 1140).
    \222\ See, e.g., A. Henley (Comment 151); T. Vail 
(Comment 211); C. Lesko, M.D., FACS (Comment 960); 
Your Family Eye Doctors, Inc. (Comment 705).
---------------------------------------------------------------------------

    Moreover, as noted above, the Act requires that any alternative 
verification period be ``similar'' to the eight-business-hour period 
contained in the Act.\223\ The commenters' suggested verification 
periods ranged from 12 business hours to one month.\224\ Such 
verification periods would significantly exceed the eight-business-hour 
period contained in the Act. Consequently, the Commission has concluded 
that the commenters' proposed standards are not sufficiently 
``similar'' to the eight-business-hour period contained in the Act to 
warrant adoption.
---------------------------------------------------------------------------

    \223\ See 15 U.S.C. 7603(d)(3).
    \224\ E.g. American Optometric Association (Comment 
1149) (proposing a minimum of 12 business hours); B. Athwal 
(Comment 188) (suggesting one month).
---------------------------------------------------------------------------

c. The Verification Process
    Communication between prescribers and sellers forms the foundation 
for section 315.5(c) of the Rule. However, a number of prescribers' 
trade associations and individual prescribers commented that 
prescribers regularly have difficulty communicating with sellers 
because sellers' telephone and fax lines are busy.\225\ Several of 
these commenters recommended that the Rule expressly require sellers to 
maintain sufficient telephone and fax lines to communicate with 
prescribers.\226\ A few commenters further requested that sellers be 
required to provide toll-free telephone and fax lines to receive 
communications from prescribers, although one seller argued against 
such a requirement.\227\
---------------------------------------------------------------------------

    \225\ National Association of Optometrists and Opticians 
(Comment 1146); American Optometric Association (Comment 
1149); Kansas Board of Examiners in Optometry (Comment 
1007); Kentucky Optometric Association (Comment 
1101); Ohio Optometric Association (Comment 1151); 
Pennsylvania Optometric Association (Comment 959); P. 
Suscavage (Comment 20); D. Deeds (Comment 13); T. 
Vail (Comment 211); W. West (Comment 126); W.G. 
Wilde, O.D., P.C. (Comment 284); C.J. Jensen, O.D., 
F.A.A.O. (Comment 305).
    \226\ E.g., National Association of Optometrists and Opticians 
(Comment 1146); American Optometric Association (Comment 
1149); Kansas Board of Examiners in Optometry (Comment 
1007); Kentucky Optometric Association (Comment 
1101); Ohio Optometric Association (Comment 1151) 
(recommending that 90% of first time calls should not reach a busy 
signal and that sellers provide evidence of adequate communications 
access to the Commission through periodic phone/Internet provider 
audit confirmation); Wheaton Eye Clinic (Comment 416).
    \227\ E.g., Kentucky Optometric Association (Comment 
1101) (in favor of toll-free lines); W. West (Comment 
126) (in favor of toll-free lines); Wal-Mart Optical 
Division (Comment 1070) (against toll-free lines).
---------------------------------------------------------------------------

    The Act implies that prescribers will have an opportunity to 
respond to verification requests. The Commission declines to articulate 
with specificity the equipment or personnel that sellers must have to 
handle verification requests, so that they will have flexibility in 
determining the most effective and efficient means of providing this 
opportunity.\228\ Instead, the final Rule mandates that sellers provide 
prescribers a ``reasonable opportunity'' for the prescriber to 
communicate with the seller regarding such requests.\229\
---------------------------------------------------------------------------

    \228\ Some other consumer protection statutes that the 
Commission enforces expressly address the issue of how a business 
must respond to requests. E.g., Fair Credit Reporting Act, 15 U.S.C. 
1581g(c)(1)(B) (requiring nationwide consumer reporting agencies to 
provide ``a toll-free telephone number established by the agency at 
which personnel are accessible to consumers during normal business 
hours'').
    \229\ Moreover, nothing in the Act or Rule prohibits sellers 
from establishing toll-free lines to facilitate communications with 
prescribers.
---------------------------------------------------------------------------

    Several prescriber trade associations and at least one prescriber 
suggested that prescribers be allowed to respond to a verification 
request by submitting a copy of the patient's prescription to the 
seller.\230\ The Commission agrees that the prescriber may provide the 
seller with a copy of the actual prescription in response to a 
verification request. However, to be considered a valid response to a 
verification request, the prescription must include all of the 
information necessary to correct any inaccuracies contained in the 
verification request, as required by section 315.5(d) of the Rule.
---------------------------------------------------------------------------

    \230\ Kansas Optometric Association (Comment 1153); New 
Mexico Optometric Assoc (Comment 1081); Ohio Optometric 
Association (Comment 1151); J.B. Rogers, O.D. (Comment 
1119).
---------------------------------------------------------------------------

    One prescriber suggested that a national database of contact lens 
prescriptions be created to allow prescribers and sellers to 
communicate.\231\ The creation of such a database is beyond the mandate 
of the Act.
---------------------------------------------------------------------------

    \231\ K. Poindexter (Comment 260).
---------------------------------------------------------------------------

d. Pre-Verification Obligations
    Several State optometric associations suggested that patients 
should be required to certify that they have had an eye examination in 
the past one or two years or, alternatively, should be asked by the 
seller if they have had an eye exam in the past one or two years.\232\ 
The Act does not impose either a certification obligation on patients 
or a notification obligation on sellers. Moreover, the evidence in the 
record is not sufficient to determine whether such requirements would 
benefit consumers. The Commission therefore declines to include such 
requirements in the final Rule.
---------------------------------------------------------------------------

    \232\ Kansas Optometric Association (Comment 1153); New 
Mexico Optometric Association (Comment 1081); Arizona 
Optometric Association (Comment 1072); Ohio Optometric 
Association (Comment 1151).
---------------------------------------------------------------------------

e. Post-Verification Obligations
    A significant number of prescriber trade associations and 
individual prescribers suggested that the Rule be modified to require 
sellers to notify prescribers when the seller fills a patient's contact 
lens order and to include in that notification the quantity of contact 
lenses it supplied to the patient.\233\ Some commenters pointed

[[Page 40500]]

out that such notification would be especially important for orders 
verified under the passive verification mechanism.\234\ The commenters 
argued that, without notification, a patient may be able to evade the 
prescription's expiration date by ordering from multiple sellers \235\ 
or by ordering more refills than allowed by the prescription.\236\ A 
few prescribers suggested that the seller be required to notify the 
patient when the patient's contact lens prescription is filled via 
passive verification,\237\ and one State optometry board suggested that 
the seller be required to notify the patient if the prescriber refuses 
to verify a prescription.\238\
---------------------------------------------------------------------------

    \233\ American Optometric Association (Comment 1149); 
Nebraska Optometric Association (Comment 1083); New York 
State Optometric Association (Comment 1073); Oklahoma Assoc 
of Optometric Physicians (Comment 1125); Kansas Optometric 
Association (Comment 1153); New Mexico Optometric 
Association (Comment 1081); Kentucky Optometric Association 
(Comment 1101); Arizona Optometric Association. (Comment 
1072); Ohio Optometric Association (Comment 1151); 
K. Driver, O.D. (Comment 273); C. Lesko, M.D., FACS 
(Comment 960); Olathe Family Vision (Comment 971); 
S. Bryant, O.D. (Comment 1127); R. Jackson (O.D. (Comment 
963); G. Lozada (Comment 1063); M. Turner, O.D. 
(Comment 1058); Jackson & Baalman (Comment 1084); 
S.J. St. Marie, O.D. (Comment 1121); J. B. Rogers, O.D. 
(Comment 1119) (prescriber should be notified of all 
passive verification sales); S. Carpenter (Comment 182); W. 
Vietti, O.D. (Comment 127).
    \234\ E.g., Nebraska Optometric Association (Comment 
1083); New Mexico Optometric Assoc (Comment 1081); 
Ohio Optometric Association (Comment 1151); C. Lesko, M.D., 
FACS (Comment 960); M. Turner, O.D. (Comment 
1058); J.B. Rogers, O.D. (Comment 1119).
    \235\ E.g., American Optometric Association (Comment 
1149); Nebraska Optometric Association (Comment 
1083); New York State Optometric Assoc (Comment 
1073); S.J. St. Marie, O.D. (Comment 1121). 
Several additional commenters did not propose a refill notification 
mechanism, but expressed concern about patients who order from 
multiple sellers in order to evade expiration dates and other 
prescription limitations. E.g., E. Attaya (Comment 952); M. 
Dean (Comment 457); D. Howard, O.D. (Comment 987); 
Your Family Eye Doctors, Inc. (Comment 705); A. Lee 
(Comment 1096).
    \236\ E.g., Nebraska Optometric Association (Comment 
1083); K. Driver, O.D. (Comment 273).
    \237\ D. Pao (Comment 139); E. Lamp, O.D. (Comment 
174).
    \238\ Kansas Board of Examiners in Optometry (Comment 
1007).
---------------------------------------------------------------------------

    In contrast to the prescribers, sellers argued that any attempt by 
prescribers to limit the quantity of contact lenses supplied to 
patients under a current prescription would be unwarranted under the 
Act.\239\ An academic ophthalmologist commented that, if quantity 
limits are imposed, patients who tear or lose their lenses or who have 
to replace lenses more frequently may have prescriptions that run out 
before they expire.\240\ One seller also pointed out that patients may 
choose to replace lenses more frequently than recommended by their 
prescriber, and that such choices may be potentially healthier for 
patients.\241\
---------------------------------------------------------------------------

    \239\ AC Lens (Comment 974); William F. Shughart, II, 
Ph.D., on behalf of 1-800-CONTACTS (Comment 975).
    \240\ P.S. D'Arienzo, M.D. (Comment 1056).
    \241\ AC Lens (Comment 974); P.S. D'Arienzo, M.D. 
(Comment 1056).
---------------------------------------------------------------------------

    After reviewing the comments, the Commission has decided not to 
require contact lens sellers to notify prescribers or patients when 
contact lenses are supplied to patients or when a prescriber refuses to 
verify a prescription. The Act does not impose such notification 
requirements. Moreover, although the Act creates a prescription release 
and verification system for contact lenses, it does not impose any 
post-verification obligations (other than recordkeeping requirements) 
on sellers, prescribers, or patients. Consequently, the Commission has 
concluded that the imposition of the suggested post-verification 
notification obligation upon sellers would be beyond the mandate of the 
Act.
    One seller commented that if passive verification has occurred 
under section 315.5(c)(3) of the Rule and the seller does not know the 
prescription expiration date,\242\ the seller should presume that the 
prescription is valid for only 30 days and supply lenses 
accordingly.\243\ The Commission has concluded that such a 30-day 
presumed expiration date falls outside the mandate of the Act. The Act 
creates a regulatory regime which, aside from recordkeeping 
obligations, ends once passive verification has occurred. Although the 
Act does not require sellers to presume such a 30-day expiration date, 
it also does not prohibit them from doing so.
---------------------------------------------------------------------------

    \242\ Although passive verification cannot occur if the 
verification request is incomplete, neither the Act nor the final 
Rule requires sellers to include an expiration date in such a 
request. See 15 U.S.C. 7603(c); Section 315.5(b) of final Rule.
    \243\ Wal-Mart Optical Division (Comment 1070).
---------------------------------------------------------------------------

    One State optometry board recommended that the seller be prohibited 
from shipping contact lenses or shipping additional contact lenses to a 
patient if the prescriber notifies the seller that the prescription is 
inaccurate, invalid or expired after the eight-business-hour period has 
passed.\244\ One seller similarly recommended that the seller be 
required to notify the patient and permit the patient to return the 
unused lenses to the seller if the prescriber's negative response is 
received after the eight-business-hour period has passed.\245\ The 
Commission believes that, aside from recordkeeping obligations, the 
statutory regime imposed by the Act ends when the eight-business-hour 
period has passed. Consequently, the requested changes fall outside the 
requirements of the Act. Nevertheless, the Commission notes that 
nothing in the statute or the Rule prohibits a prescriber from 
submitting such notifications to the seller or the seller from acting 
upon such notifications. It would likely be in the best interest of 
their common customer, the patient, for them to do so.
---------------------------------------------------------------------------

    \244\ Kansas Board of Examiners in Optometry (Comment 
1007).
    \245\ 1-800 CONTACTS (Comment 1140).
---------------------------------------------------------------------------

    One prescribers' trade association recommended that a seller be 
required to document that a prescriber is licensed whenever it fills a 
prescription via passive verification.\246\ The commenter indicated 
that such a requirement would prevent patients from using fictional 
prescriber contact information to obtain contact lenses through passive 
verification. The Act does not impose such a requirement. Furthermore, 
the Commission notes that the record does not contain any data 
regarding patients' submission of fictional prescriber contact 
information to sellers. Absent such information, the Commission cannot 
determine whether the license verification obligation suggested would 
benefit consumers. The Commission thus has not included a license 
verification requirement in the final Rule.
---------------------------------------------------------------------------

    \246\ Texas Ophthalmological Association (Comment 
1117).
---------------------------------------------------------------------------

    Another prescribers' trade association recommended that sellers 
provide a written message [``Warning: If you are having any of the 
following symptoms, remove your contact lenses immediately and consult 
your eye care practitioner before wearing your lenses again: 
unexplained eye discomfort, watering, vision change or redness.''] 
whenever lenses are supplied to a patient.\247\ The commenter pointed 
out that its State law imposes such a notification requirement. Because 
the Act does not require such a warning, and the record does not 
contain sufficient evidence to determine whether such a requirement 
would benefit consumers, the Commission has not included such a 
requirement in the final Rule. Nevertheless, except as discussed below 
in the preemption section, the Commission notes that the Act does not 
alter the obligation to comply with applicable State law.
---------------------------------------------------------------------------

    \247\ Kentucky Optometric Association (Comment 1101).
---------------------------------------------------------------------------

f. The Verification Process and HIPAA
    In the NPRM, the Commission asked whether the Health Insurance 
Portability and Accountability Act of 1996 (``HIPAA'')\248\ limits or 
otherwise affects prescribers'' ability to respond to a verification 
request under the Act.\249\ Among other things, HIPAA and its 
implementing Privacy Rule (entitled ``Standards for Privacy of 
Individually

[[Page 40501]]

Identifiable Health Information'')\250\ limit the circumstances under 
which a covered entity may disclose individually identifiable health 
information without prior written authorization from the patient. The 
Act itself did not expressly address HIPAA, but the Commission sought 
comment on the issue because verification of a patient's contact lens 
prescription information may entail the disclosure of individually 
identifiable health information protected by the Privacy Rule.
---------------------------------------------------------------------------

    \248\ Pub. L. 104-191 (Aug. 21, 1996).
    \249\ See 69 FR at 5447.
    \250\ 45 CFR Parts 160, 164.
---------------------------------------------------------------------------

    The majority of the commenters on this question agreed that the 
Privacy Rule permits eye care providers to provide contact lens 
prescription verification information to an authorized third-party 
seller without the patient's written authorization.\251\
---------------------------------------------------------------------------

    \251\ E.g., AC Lens (Comment 974); American Academy of 
Ophthalmology (Comment 1057); Wal-Mart Optical Division 
(Comment 1070); 1-800 CONTACTS (Comment 1140); 
American Society for Cataract and Refractive Surgery (Comment 
1148).
---------------------------------------------------------------------------

    One commenter noted that the preamble to the HIPAA Privacy Rule 
specifically indicates that disclosure of protected health information 
by an eye doctor to a distributor of contact lenses for the purpose of 
confirming a contact lens prescription is considered ``treatment,'' and 
Section 164.506 of the HIPAA Privacy Rule permits disclosure under such 
circumstances.\252\ Another commenter recommended that the Commission 
include language in the final Rule clarifying that contact lens sellers 
are ``health care providers'' under the Privacy Rule when selling or 
dispensing lenses pursuant to a prescription, and thus the 
``treatment'' provision permits prescribers to verify prescription 
information to such sellers.\253\
---------------------------------------------------------------------------

    \252\ American Society for Cataract and Refractive Surgery 
(Comment 1148) (citing preamble to HIPAA Privacy Rule, 67 
FR 53219 (Aug. 14, 2002)). See also AC Lens (Comment 974) 
(stating disclosure of prescription information is permitted as 
``treatment'' under 45 CFR 164.506); 1-800 CONTACTS (Comment 
1140) (same).
    \253\ American Academy of Ophthalmology (Comment 1057). 
This commenter also urged the Commission to examine HIPAA's small 
business exemptions to determine whether they are applicable to the 
proposed rule or in conflict with it. The Commission is not aware of 
any such exemptions.
---------------------------------------------------------------------------

    A few commenters disagreed, stating that a prescription 
verification request should be accompanied by a signed authorization 
from the patient to release the medical information.\254\
---------------------------------------------------------------------------

    \254\ Tupelo Eye Clinic (Comment 11); S. Carpenter 
(Comment 182); D. Dwyer, M.D. (Comment 275); 
Association of Regulatory Boards of Optometry (Comment 
1154).
---------------------------------------------------------------------------

    The Commission does not believe that the HIPAA Privacy Rule limits 
prescribers' ability to verify contact lens prescriptions under the 
Contact Lens Rule. First, the HIPAA Privacy Rule permits a ``covered 
entity'' to use or disclose protected health information without 
patient authorization ``for treatment, payment, or health care 
operations.'' \255\ Providing, confirming or correcting a prescription 
for contact lenses to a seller designated by the patient constitutes 
``treatment'' under the Privacy Rule.\256\ Second, the HIPAA Privacy 
Rule allows ``covered entities'' to use or disclose protected health 
information without patient authorization if the use or disclosure is 
``required by law.'' \257\ To the extent the disclosure of protected 
health information needed to provide, confirm, or verify a contact lens 
prescription is required under the Act and the Rule, such disclosure 
constitutes a disclosure required by law under the HIPAA Privacy 
Rule.\258\ Accordingly, the Commission does not believe it needs to 
revise the proposed Rule to address HIPAA-related issues.
---------------------------------------------------------------------------

    \255\ See 45 CFR 164.506.
    \256\ See 67 FR 53219 (Aug. 14, 2002). See also the FAQ on the 
HHS Office for Civil Rights HIPAA Privacy Web site at http://www.hhs.gov/ocr/hipaa, entitled ``Does the HIPAA Privacy Rule permit 
an eye doctor to confirm a contact [lens] prescription received by a 
mail-order contact company?'' (Answer ID 270). Answer: 
``Yes. The disclosure of protected health information by an eye 
doctor to a distributor of contact lenses for the purpose of 
confirming a contact lens prescription is a treatment disclosure, 
and is permitted under the Privacy Rule at 45 CFR 164.506.''
    \257\ See 45 CFR 164.512(a).
    \258\ For example, a prescriber is required by the Act and Rule 
to provide a contact lens prescription to a designated contact lens 
seller. See 15 U.S.C. 7601(a)(2); 16 CFR 315.3(a)(2). In addition, a 
prescriber who responds to a seller's prescription verification 
request and states that the prescription information is inaccurate 
must provide the correct information. See 15 U.S.C. 7603(e); 16 CFR 
315.5(d).
---------------------------------------------------------------------------

4. 315.5(d)--Invalid Prescription
    Section 315.5(d) of the proposed Rule states that if ``a prescriber 
informs a seller before the deadline under paragraph (c)(3) of this 
section that the contact lens prescription is inaccurate, expired, or 
otherwise invalid, the seller shall not fill the prescription. The 
prescriber shall specify the basis for the inaccuracy or invalidity of 
the prescription. If the prescription communicated by the seller to the 
prescriber is inaccurate, the prescriber shall correct it, and the 
prescription shall then be deemed verified under paragraph (c)(2) of 
this section.'' \259\ This provision was derived from Section 4(e) of 
the Act.\260\ For the reasons discussed below, the Commission adopts 
this provision without modification in the final Rule.
---------------------------------------------------------------------------

    \259\ 69 FR at 5449.
    \260\ See 15 U.S.C. 7603(e).
---------------------------------------------------------------------------

a. Inaccurate Prescriptions
    If some of the information on a verification request is incorrect, 
but can be corrected, the prescription is ``inaccurate'' for purposes 
of section 315.5(d) of the Rule. Several commenters addressed the issue 
of inaccurate prescriptions. A few State optometric associations 
requested that the eight-business-hour prescription verification period 
be extended or treated as a new request when a prescriber notifies the 
seller that a correction is required.\261\ In contrast, one seller 
indicated that the Rule should expressly state that a prescriber must 
provide accurate prescription information at the same time that the 
prescriber informs the seller that the prescription is inaccurate.\262\ 
After reviewing the comments, the Commission has concluded that the 
prescriber must provide the correct information at the same time that 
the prescriber informs the seller that the prescription is inaccurate. 
Nothing in the Act indicates that Congress intended to extend the 
prescription verification period (including triggering a new eight-
business-hour period) if the prescriber has determined that a 
prescription is inaccurate.
---------------------------------------------------------------------------

    \261\ Ohio Optometric Association (Comment  1151); 
Kansas Optometric Association (Comment 1153); New Mexico 
Optometric Association (Comment 1081).
    \262\ Wal-Mart Optical Division (Comment 1070).
---------------------------------------------------------------------------

    One State optometric association suggested that sellers be required 
to verify receipt of corrections submitted by prescribers.\263\ The 
Commission declines to make the requested change because nothing in the 
Act contemplates the imposition of such a notification requirement on 
sellers.
---------------------------------------------------------------------------

    \263\ Nebraska Optometric Association (Comment 1083).
---------------------------------------------------------------------------

    The Commission also has concluded that the quantity ordered may be 
a legitimate basis for a prescriber to treat a request for verification 
of a prescription as ``inaccurate,'' because Congress indicated in 
section 4(c) of the Act that the quantity of lenses ordered is relevant 
information by requiring sellers to include the quantity ordered in 
prescription verification requests.\264\ For example, if a verification 
request indicates that a patient seeks to purchase a nine-month supply 
of lenses only one month before the prescription expires, the 
prescriber may treat the

[[Page 40502]]

verification request as inaccurate. Under such circumstances, the 
prescriber would be required to provide the seller with information 
regarding the basis for the inaccuracy as well as to correct the 
prescription by specifying an appropriate number of lenses to be 
dispensed.\265\
---------------------------------------------------------------------------

    \264\ See 15 U.S.C. 7603(c)(3).
    \265\ A few prescribers commented that they are amenable to such 
an approach. M. Walker (Comment 165) (would like the right 
to limit the number of boxes prescribed to the time remaining on the 
prescription before expiration); D. Hughes (Comment 712) 
(prescriber should be allowed to approve a verification request but 
limit the number of boxes consistent with the prescription 
expiration date).
---------------------------------------------------------------------------

b. Expired Prescriptions
    If a seller seeks verification of a prescription for which the 
expiration date has passed, the prescription is ``expired'' for 
purposes of section 315.5(d) of the Rule. Numerous commenters addressed 
prescribers' obligations with respect to expired prescriptions. One 
seller recommended that the Rule explicitly require prescribers to 
provide sellers the examination date and prescription issue date when 
reporting that a prescription has expired.\266\ This seller was 
concerned that, without such an obligation, prescribers may use the 
``expired'' option to avoid complying with prescription verification 
obligations. Numerous prescriber groups and prescribers, in contrast, 
commented that sellers are either not honoring prescribers' responses 
that a prescription is expired or are not honoring such responses 
unless the prescriber provides additional information regarding the 
expired prescription.\267\
---------------------------------------------------------------------------

    \266\ 1-800 CONTACTS (Comment 1140).
    \267\ American Academy of Ophthalmology (Comment 1057); 
National Association of Optometrists and Opticians (Comment 
1146); Wisconsin Optometric Association (Comment 
1086); P. Butler (Comment 730); Pennsylvania 
Optometric Association (Comment 959); F. Aulicino (Comment 
167); Family Vision Care (Comments 130, 
397); T. Pierzchala (Comment 243); K.S. Aldridge, DO 
(Comment 1106); M. Malone (Comment 1123); Low 
Country Vision Center (Comment 406, 1183); T. 
Copelovitch (Comment 214); D. Ball (Comment 849); 
D. Tabak (Comment 23); M. Spittler (Comment 158).
---------------------------------------------------------------------------

    The Commission has concluded that prescribers should be allowed to 
respond that a prescription is ``expired'' without providing additional 
information to the seller. Section 4(e) of the Act establishes three 
categories of invalid prescriptions (i.e., inaccurate, expired, and 
otherwise invalid).\268\ Section 4(e) then requires prescribers to 
``specify the basis for the inaccuracy or invalidity'' only if a 
particular prescription is designated as inaccurate or invalid.\269\ 
The Act does not impose a similar additional information requirement 
for expired prescriptions. Consequently, the Commission has decided not 
to require prescribers to provide additional information, such as the 
examination date or the prescription issue date, when they respond that 
a prescription is expired, although they may choose to do so.\270\
---------------------------------------------------------------------------

    \268\ See 15 U.S.C. 7603(e).
    \269\ Ibid.
    \270\ When a prescriber responds to a verification request by 
indicating that a patient's prescription has ``expired,'' the seller 
may not ship lenses to that patient.
---------------------------------------------------------------------------

    A number of prescribers indicated that a prescription should be 
deemed expired for purposes of section 315.5(d) of the Rule when the 
prescribed number of refills has been filled.\271\ For the reasons 
provided above in the discussion of ``inaccurate'' prescriptions, the 
Commission has concluded that prescribers may treat a verification 
request as ``inaccurate'' rather than as ``expired'' based on the 
relationship between the quantity of lenses ordered (as indicated in 
the verification request) and the expiration date of the prescription. 
In such situations, the prescriber must provide corrected information 
to the seller as to the quantity of lenses that may be ordered under an 
accurate verification request.
---------------------------------------------------------------------------

    \271\ New York State Optometric Association (Comment 
1073); Oklahoma Association of Optometric Physicians 
(Comment 1125); Kansas Optometric Association (Comment 
1153); New Mexico Optometric Association (Comment 
1081); M. Dean (Comment 457).
---------------------------------------------------------------------------

c. Invalid Prescriptions
    An ``otherwise invalid'' prescription under section 315.5(d) of the 
Rule includes, for example, situations where the verification request 
does not contain sufficient information to allow the prescriber to 
identify the patient, identifies a person who is not the prescriber's 
patient, or identifies a patient who has developed a medical condition 
which prohibits the use of contact lenses.
    One seller requested that the Commission expressly define an 
invalid prescription as one that has expired or does not apply to the 
buyer.\272\ The seller argued that prescribers should not be able to 
define ``invalid'' in a subjective manner, and that the prescriber's 
burden to correct an invalid prescription should be the same as the 
prescriber's burden to correct an inaccurate prescription. The 
Commission declines to make the requested changes because Section 4(e) 
of the Act clearly identifies three categories of invalid prescriptions 
(inaccurate, expired, and otherwise invalid) with different obligations 
imposed on prescribers for each category.\273\ The Commission notes, 
however, that section 315.5(d) of the final Rule requires a prescriber 
who designates a prescription as invalid to specify the basis for the 
invalidity.
---------------------------------------------------------------------------

    \272\ Wal-Mart Optical Division (Comment 1070).
    \273\ See 15 U.S.C. 7603(e).
---------------------------------------------------------------------------

d. Multiple Verification Requests
    Several prescriber trade associations and prescribers stated that 
prescribers regularly receive multiple verification requests for the 
same patient from a seller, even after the prescriber has responded to 
the original verification request.\274\ Some trade associations 
specifically recommended that the Commission sanction sellers who 
submit multiple or frivolous verification requests.\275\ Under the Act 
and the Rule, a seller may send one verification request via direct 
communication to the prescriber.\276\ Unless a subsequent request 
contains additional or revised information, a seller may not resend 
another verification request to the prescriber.
---------------------------------------------------------------------------

    \274\ American Optometric Association (Comment 1149); 
National Association of Optometrists and Opticians (Comment 
1146); Nebraska Optometric Association (Comment 
1083); Illinois Optometric Association (Comment 
1005); Pennsylvania Optometric Association (Comment 
959); M. Onyon (Comment 161); H.G. Schneider, M.D. 
(Comment 1006); E. Attaya (Comment 952); 
Silverdale Eyecare Center (Comment 1054) (recommending that 
seller not be allowed to make multiple verification requests without 
confirming the prescriber's information with the patient ordering 
the lenses); Jackson & Baalman (Comment 1084).
    \275\ American Optometric Association (Comment 1149); 
Illinois Optometric Association (Comment 1005).
    \276\ If the verification request does not meet the ``direct 
communication'' standard set forth in section 315.2 of the Rule 
because the communication was not completed, the seller may resend 
the verification request.
---------------------------------------------------------------------------

5. 315.5(e)--No Alteration of Prescription
    Section 315.5(e) of the proposed Rule prohibits the alteration of 
prescriptions by stating that a ``seller may not alter a contact lens 
prescription. Notwithstanding the preceding sentence, 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.'' \277\ This provision is derived from section 
4(f) of the Act,\278\ and the Commission has decided to adopt the 
proposed provision without modification in the final Rule.
---------------------------------------------------------------------------

    \277\ 69 FR at 5449.
    \278\ See 15 U.S.C. 7603(f).
---------------------------------------------------------------------------

    A number of prescribers and prescriber trade associations

[[Page 40503]]

commented that sellers have been providing patients with lenses that 
are substantially different from the ones prescribed by the 
prescriber.\279\ Some commenters provided anecdotal examples in which 
sellers altered patients' prescriptions by supplying patients with 
tinted lenses, generic lenses or extended wear lenses even though such 
lenses had not been prescribed for the patient's use.\280\ The 
Commission notes that section 315.5(e) of the Rule expressly prohibits 
sellers from substituting contact lenses unless the substitution 
involves the replacement of private label lenses with identical lenses 
made by the same manufacturer but sold under the labels of other 
sellers.\281\
---------------------------------------------------------------------------

    \279\ American Optometric Association (Comment 1149); 
Kansas Optometric Association (Comment 1153); Wheaton Eye 
Clinic (Comment 416); P. Beale, O.D. (Comment 
1090, 1064); M. Malone (Comment 1123); D.K. Boltz 
(Comment 175).
    \280\ E.g., Wheaton Eye Clinic (Comment 416) (tinted 
lenses); P. Beale, O.D., FAAO (Comment 1090, 1064) (generic 
lenses); D. K. Boltz (Comment 175) (switching patient from 
daily wear to extended wear lenses). In comparison, however, one 
State optometric association pointed out that its State law allows 
sellers to change the color of a contact lens without penalty, and 
noted that the experience in that State has not resulted in any 
problems. California Optometric Association (Comment  
1158).
    \281\ Some prescribers suggested that sellers be prohibited from 
supplying a brand of lens other than the one prescribed by the 
seller. E.g., D.L. Rodrigue (Comment 1102); B.L.Whitesell, 
O.D. (Comment 1115); A. Lee (Comment 1096); M. 
Malone (Comment 1123). The Commission notes that Section 
4(f) of the Act, 15 U.S.C. 7603(f), expressly exempts private label 
lenses from the general ban on contact lens substitutions. If a 
seller's substitution of one lens brand for another lens brand 
qualifies as a private label substitution under the Rule, the 
substitution would not violate the Rule's requirements.
---------------------------------------------------------------------------

    One seller commented that the Act is based on the assumption that 
sellers can easily obtain equivalent national brands for private label 
lenses, but, the seller argued, this assumption is incorrect.\282\ 
According to the seller, manufacturers have cut off entities who supply 
such lenses to alternative sellers. The seller suggested that the Rule 
require prescribers who prescribe private label brands to include on 
the prescription the name of a brand sold directly to alternative 
sellers. Nothing in the Act contemplates the imposition of such a 
disclosure requirement on prescribers.
---------------------------------------------------------------------------

    \282\ 1-800 CONTACTS (Comment 1140).
---------------------------------------------------------------------------

6. 315.5(f)--Recordkeeping for Verification Requests
    In accordance with the Act,\283\ section 315.5(f) of the proposed 
Rule would require sellers to maintain, for a period of at least three 
years, records of all direct communications relating to prescription 
verification, as well as any prescriptions they receive from patients 
or prescribers.\284\ As stated in the NPRM, the purpose of these 
recordkeeping requirements is to allow the Commission to investigate 
whether there has been a rule violation and to seek civil penalties for 
any such violations.\285\ The Commission has slightly revised this 
provision as discussed below.
---------------------------------------------------------------------------

    \283\ See 15 U.S.C. 7603(b).
    \284\ 69 FR at 5449.
    \285\ 69 FR at 5442.
---------------------------------------------------------------------------

a. Copies of Prescriptions
    Paragraph 315.5(f)(1) of the proposed Rule would require that 
sellers keep copies of prescriptions (including an e-mail containing a 
digital image of the prescription) or fax copies of prescriptions they 
receive directly from a patient or a prescriber.\286\ The Commission 
received no comments on this provision, and adopts it without 
modification in the final Rule.
---------------------------------------------------------------------------

    \286\ See 69 FR at 5449.
---------------------------------------------------------------------------

b. Documentation of Verification Requests
    Paragraphs 315.5(f)(2) and (3) of the proposed Rule specified the 
documentation sellers would have to maintain relating to verification 
requests.\287\ The required recordkeeping would vary based on the means 
of direct communication used by the seller or prescriber. If a seller 
communicates through facsimile or e-mail, it would have to maintain a 
copy of the verification request and a confirmation of the completed 
communication of that request. If the seller communicates through 
telephone, it would have to maintain a telephone log describing the 
information that the seller provided to the prescriber (e.g., noting 
that the seller read the required prescription information to the 
prescriber); recording the date and time the telephone call was 
completed; and indicating how the call was completed (e.g., by speaking 
with someone directly (and if so whom) or by leaving a message).\288\ 
In addition, for communications by telephone, the seller would have to 
retain copies of its telephone bills.\289\ Required records of 
communications from prescribers would be similar.\290\
---------------------------------------------------------------------------

    \287\ See 69 FR at 5449.
    \288\ See 69 FR at 5443, 5449.
    \289\ See 69 FR at 5443.
    \290\ Section 315.5(f)(3) of the proposed Rule would require a 
seller to maintain a copy of any fax or e-mail communication from a 
prescriber, and a record of the time and date it was received; for a 
telephone communication, the seller would maintain a telephone log 
describing the information communicated and the date and time it was 
received.
---------------------------------------------------------------------------

    The Commission received several comments on its proposed 
recordkeeping provision. Some commenters agreed with the provision 
generally.\291\ Some commenters suggested the Rule also require, for 
telephone communications, the name of the person at the prescriber's 
office with whom the seller spoke, as well as the person calling on 
behalf of the seller.\292\ Two sellers suggested eliminating the 
requirement that they preserve telephone bills, arguing that the 
requirement is burdensome and the bills can be obtained from the 
telephone company if necessary.\293\ Also, two commenters requested 
that the Rule allow the seller to keep the required telephone logs in 
electronic format.\294\ Finally, some commenters sought clarification 
of what constitutes the required confirmation of a completed 
verification request.\295\
---------------------------------------------------------------------------

    \291\ E.g., AC Lens (Comment 974) (recordkeeping 
requirements are reasonable); Kansas Board of Examiners in Optometry 
(Comment 1007) (preservation of confirmation that a 
facsimile or e-mail communication was successful will be crucial for 
enforcement: ``Because the seller will be entrusted with determining 
when the eight business hour period expires, it is important the 
seller have verification the request has been received.''); K. 
Poindexter (Comment 260) (seller should have to keep copies 
of all verification requests sent).
    \292\ E.g., American Optometric Association (Comment 
1149); Kansas Board of Examiners in Optometry (Comment 
1007) (names of person(s) involved in the communication is 
key for investigating complaints and will foster accountability).
    \293\ Costco Wholesale Corporation (Comment 1061); Wal-
Mart Optical Division (Comment 1070).
    \294\ Wal-Mart Optical Division (Comment 1070); AC Lens 
(Comment 974).
    \295\ E.g., K. Poindexter (Comment 260); see also Wal-
Mart Optical Division (Comment 1070) (for e-mails, saving 
the e-mail should be sufficient; seller should not have to verify 
that e-mail was received but should save notice of nondelivery if 
received). The Commission has addressed this issue in its discussion 
of the definition of ``direct communication'' elsewhere in this 
notice.
---------------------------------------------------------------------------

    Having considered the comments, the Commission has revised the 
proposed Rule to: (1) Require records of telephone communications to 
include the names of the individuals who participated in the call; (2) 
eliminate the requirement that sellers retain telephone bills; and (3) 
permit electronic storage of logs and other records. The Commission 
believes these revisions will further the recordkeeping requirements' 
purpose of facilitating investigation of whether a rule violation has 
occurred, and also reduce the burden on sellers of maintaining 
documents.
7. 315.5(g)--Recordkeeping for Saturday Business Hours
    As set forth above in the Commission's discussion of the

[[Page 40504]]

definition of ``business hour,'' the final Rule gives contact lens 
sellers the option to include a prescriber's regular Saturday business 
hours in the eight-hour verification period, if the seller has actual 
knowledge of those hours. In addition, the final Rule incorporates a 
new provision--section 315.5(g)--which requires that a seller 
exercising this option must maintain a record of the prescriber's 
regular Saturday business hours and the basis for the seller's actual 
knowledge thereof--i.e., how the seller determined the hours. This new 
provision is intended to ensure that sellers have a sound basis for 
their actual knowledge, and to facilitate review by the Commission of 
seller's practices in using Saturday business hours for prescription 
verification.\296\
---------------------------------------------------------------------------

    \296\ This optional recordkeeping requirement is not a 
substantive or material modification to the collection of 
information that the Office of Management and Budget has approved 
under the Paperwork Reduction Act. See 5 CFR 1320.5(g). Moreover, 
the Commission believes that only a few contact lens sellers will 
use the option of including a prescriber's regular Saturday hours in 
the eight hour verification period. Therefore, any increase in 
burden under the PRA will not be significant, and in any event would 
be offset by the decrease in burden that results from the changes in 
the recordkeeping requirements that are applicable to all sellers.
---------------------------------------------------------------------------

F. Section 315.6: Expiration of Contact Lens Prescriptions

    Section 315.6 of the Commission's proposed Rule addresses 
expiration dates for contact lens prescriptions and closely tracks the 
requirements set forth in the Act.\297\ Specifically, the proposed Rule 
provides that a contact lens prescription expires: (1) On the date 
specified by State law, if that date is one year or more after the 
issue date of the prescription; (2) not less than one year after the 
issue date if the expiration date under State law is less than one year 
after its issue date, or the State law does not specify an expiration 
date; or (3) on a different expiration date based on a prescriber's 
medical judgment with respect to the ocular health of the particular 
patient. If a prescriber specifies an expiration date of less than one 
year from the issue date, the prescriber must document the relevant 
medical reasons in the patient's medical record with sufficient detail 
to allow a qualified medical professional to determine the 
reasonableness of the shorter expiration date, and must retain such 
documentation for at least three years. As noted in the NPRM, the 
purpose of establishing a minimum expiration date as a matter of 
Federal law is to prevent prescribers from selecting a short expiration 
date for a prescription that unduly limits the ability of consumers to 
purchase contact lenses from other sellers, unless legitimate medical 
reasons justify setting such an expiration date.\298\
---------------------------------------------------------------------------

    \297\ See 69 FR at 5449-5450; 15 U.S.C. 7604.
    \298\ 69 FR at 5443.
---------------------------------------------------------------------------

    The Commission received several comments on this provision of the 
proposed Rule. For the reasons set forth below, the Commission has 
retained this provision as originally proposed.
1. One Year Minimum Expiration Period
    With respect to the general rule that a prescription shall expire 
not less than one year after its issue date, some commenters agreed 
with the minimum and wanted State laws specifying short expiration 
periods to be preempted.\299\ Other commenters stated that the minimum 
expiration date should be extended to two years rather than one,\300\ 
while another commenter asked the Commission to strike ``not less 
than'' and thereby set a definitive expiration date of one year.\301\ 
Based on the Act, the Commission concludes that Congress intended to 
defer to applicable state law except where such law establishes an 
expiration period of less than one year.
---------------------------------------------------------------------------

    \299\ E.g., Wal-Mart Optical Division (Comment 1070).
    \300\ S. Cutter (Comment 184) (one year is too short); 
R.Weigner (Comment 1118) (HMOs pay for eye exams every two 
years).
    \301\ K. Green (Comment 4) (stating that the standard 
of care calls for an annual contact lens follow-up exam--or less if 
medically indicated--and that the Commission should not dictate 
medical standard of care).
---------------------------------------------------------------------------

2. Medical Judgment for an Expiration Date of Less Than One Year
    In its NPRM, the Commission specifically sought comment on what 
circumstances would provide a legitimate medical reason for setting an 
expiration date of less than one year.\302\ Commenters cited 
circumstances including neovascularization of the cornea, hypoxia, 
diabetes, corneal degenerations (i.e., keratoconus), history of 
frequent conjunctivitis, history of non-compliance with wearing 
schedules, and new contact lens wearers.\303\ The Commission's Rule is 
premised on the expectation that prescribers will use applicable 
standards of care in determining whether medical reasons necessitate a 
prescription expiration period of less than one year.
---------------------------------------------------------------------------

    \302\ 69 FR at 5448.
    \303\ American Optometric Association (Comment 1149); 
K. Poindexter (Comment 260).
---------------------------------------------------------------------------

    The Commission received several other comments relating to the 
``medical judgment'' exception. One commenter urged the Commission to 
recognize that setting a prescription expiration date of less than one 
year should occur ``only in exceptional circumstances.'' \304\ Based on 
the express language of the Act,\305\ the Commission concludes that 
Congress intended to establish a general rule governing prescription 
expiration--namely, State law or one year from issue date, whichever is 
longer--and to provide an exception to that general rule to allow for 
cases in which a shorter expiration date is medically necessary. As 
such, the Commission anticipates that prescriptions shorter than one 
year in fact will be the exception, not the rule.
---------------------------------------------------------------------------

    \304\ 1-800 CONTACTS (Comment 1140).
    \305\ 15 U.S.C. 7604.
---------------------------------------------------------------------------

    With respect to prescriptions of less than one year, section 
315.6(b) of the proposed Rule would require prescribers to document the 
medical reasons ``with sufficient detail to allow for review by a 
qualified professional in the field.'' One commenter asked the 
Commission to clarify the applicable standard of review.\306\ The 
Commission anticipates that such review would be conducted by a 
qualified professional comparable to the prescriber, such as an 
ophthalmologist reviewing documentation created by an ophthalmologist. 
The Commission does not believe it is necessary to further define the 
term.
---------------------------------------------------------------------------

    \306\ American Society for Cataract and Refractive Surgery 
(Comment 1148) (noting that the preamble to the proposed 
Rule referred to a ``qualified medical professional'' rather than a 
``qualified professional in the field''). This commenter also noted 
that the phrase ``with sufficient detail'' is not in the Act. Such a 
requirement is necessary so that the Commission can review the 
reasons for an expiration date of less than one year. The inability 
to conduct such a review could significantly compromise the 
Commission's ability to enforce this provision.
---------------------------------------------------------------------------

G. Section 315.7: Content of Advertisements and Other Representations

    Section 315.7 of the proposed Rule would prohibit any person that 
engages in the manufacture, processing, assembly, sale, offering for 
sale, or distribution of contact lenses from representing, by 
advertisement, sales presentation, or otherwise, that contact lenses 
may be obtained without a prescription.\307\ This provision was taken 
verbatim from the Act.\308\ The Commission did not receive any comments 
directly addressing this prohibition, and the Commission adopts it 
without modification in the final Rule.
---------------------------------------------------------------------------

    \307\ 69 FR at 5450.
    \308\ 15 U.S.C. 7605.
---------------------------------------------------------------------------

    Several commenters, primarily prescribers and some of their trade

[[Page 40505]]

associations, urged the Commission to add another provision to the Rule 
which would prohibit false or misleading advertisements regarding the 
Act or Rule.\309\ A number of commenters also suggested that the Rule 
specifically prohibit false or misleading ads regarding the amount a 
customer can save by purchasing contact lenses from a particular 
seller.\310\ Other commenters more generally urged the Commission to 
scrutinize sellers' advertising for deceptive claims.\311\ The Act 
addressed only one specific type of deceptive claim. Section 5 of the 
Commission Act already provides sufficient authority for the Commission 
to address other deceptive claims in advertising for contact lenses, 
and so there is no need to address them in the Rule.
---------------------------------------------------------------------------

    \309\ E.g., Nebraska Optometric Association (Comment 
1083) (also seeking prohibition against sellers falsely 
informing patients of prescribers' refusal to verify prescriptions, 
or for encouraging patients to file false complaints against 
prescribers); Ohio Optometric Association (Comment 1151) 
(same).
    \310\ E.g., North Carolina State Optometric Society (Comment 
1074); Kansas Optometric Association (Comment 
1153); New Mexico Optometric Association (Comment 
1081); Ohio Optometric Association (Comment 1151); 
M. Dean (Comment 148).
    \311\ E.g., Arizona Optometric Association. (Comment 
1072); W. West (Comment 126).
---------------------------------------------------------------------------

H. Section 315.8: Prohibition of Waivers

    Subsection 315.8 of the proposed Rule stated that a ``prescriber 
may not place on a prescription, or require the patient to sign, or 
deliver to the patient, a form or notice waiving or disclaiming the 
liability or responsibility of the prescriber for the accuracy of the 
eye examination.'' \312\ The provision further stated that the 
``preceding sentence does not impose liability on a prescriber for the 
ophthalmic goods and services dispensed by another seller pursuant to 
the prescriber's correctly verified prescription.'' \313\ This 
provision was taken verbatim from Section 7 of the Act.\314\ The 
Commission has decided to adopt this provision without modification in 
the Final Rule.
---------------------------------------------------------------------------

    \312\ 69 FR at 5450.
    \313\ Id.
    \314\ 15 U.S.C. 7606.
---------------------------------------------------------------------------

    The Commission received one comment from a prescriber who voiced 
his support for the provision.\315\ A few prescribers were concerned 
about their liability in the event that contact lenses sold to a 
patient via passive verification eventually lead to a lawsuit against 
the prescriber.\316\ Traditionally, such liability issues are 
determined by state law. Moreover, the language of the Act does not 
indicate that Congress intended to address liability issues aside from 
the specific matters covered by Section 7 of the Act.
---------------------------------------------------------------------------

    \315\ D. Pao (Comment 139).
    \316\ Tupelo Eye Clinic/Chappell (Comment 11); J.B. 
Rogers, O.D. (Comment 1119).
---------------------------------------------------------------------------

I. Section 315.9: Enforcement

    Section 315.9 of the proposed Rule addressed the Commission's 
enforcement of the Rule.\317\ Section 315.9 provided that a violation 
of the Rule ``shall be treated as a violation of a rule under Section 
18 of the Federal Trade Commission Act, 15 U.S.C. 57a,'' and also 
stated that ``the Commission will enforce this Rule in the same manner, 
by the same means, and with the same jurisdiction, powers, and duties 
as are available to it pursuant to the Federal Trade Commission Act, 15 
U.S.C. 41 et seq.'' \318\ Commenters did not suggest any changes to the 
language of this enforcement provision; the Commission is adopting it 
without modification.
---------------------------------------------------------------------------

    \317\ See 69 FR at 5450.
    \318\ Id.
---------------------------------------------------------------------------

J. Section 315.10: Severability

    Section 315.10 of the proposed Rule stated that the provisions of 
the Contact Lens Rule are separate and severable from one another, and 
that if any provision is stayed or determined to be invalid, it is the 
Commission's intention that the remaining provisions shall continue in 
effect. The Commission received no comments on this provision and 
retains it.

K. Section 315.11: Preemption

    A number of comments asked that the Commission clarify to what 
extent the final Rule preempts State law. For example, some commenters 
urged the Commission to clarify that the Rule preempts State laws on 
issues such as prescription expiration dates, the substitution of 
equivalent brand contact lenses, and other allegedly ``anti-
competitive'' State laws.\319\ One commenter sought guidance about 
whether the Act or the Rule would preempt existing State law relating 
to the release of personally identifiable information.\320\ Finally, 
other commenters asked the Commission to define the term ``seller'' to 
preempt current State laws that may seek to limit or place conditions 
on who may sell contact lenses, such as State licensing and 
registration requirements.\321\
---------------------------------------------------------------------------

    \319\ Costco Wholesale Corporation (Comment 1061) (Rule 
should make clear that State law prohibiting substitution of 
equivalent brand name lenses are superceded by Act and Rule); Wal-
Mart Optical Division (Comment 1070) (Rule should preempt 
any State law setting prescription expiration less than one year, 
and any other anti-competitive State laws); Hon. J. Sensenbrenner, 
U.S. House of Rep. (Comment 1246) (Act intended to preempt 
States from erecting regulatory or other barriers intended to 
artificially restrict or limit consumers' ability to purchase 
contact lenses from third-party sellers).
    \320\ New York State Optometric Association (Comment 
1073) (citing New York State Education Department ruling 
that the release of personally identifiable information without 
patient's prior written consent constitutes unprofessional conduct 
potentially subject to professional discipline; noting that HIPAA 
allows State privacy rules to be more restrictive than Federal 
requirements). Another commenter raised a similar issue, stating 
that Florida law prohibits optometrists from releasing patient 
information without patient consent. Florida Board of Optometry 
(Comment 1100).
    \321\ Wal-Mart Optical Division (Comment 1070); 1-800 
CONTACTS (Comment 1140).
---------------------------------------------------------------------------

    A Federal law may preempt State law either through (1) express 
statutory preemption; (2) implied preemption where the intent of the 
Federal law is to occupy the field exclusively; or (3) implied 
preemption where State and Federal law actually conflict.\322\ A 
conflict may arise where the language of Federal and State laws is 
inconsistent.\323\ A conflict also may arise if State law ``stand[s] as 
an obstacle to the accomplishment and execution of the full purposes 
and objectives of Congress.'' \324\
---------------------------------------------------------------------------

    \322\ See Lorillard Tobacco Co. v. Reilly, 533 U.S. 525, 121 S. 
Ct. 2404, 2414 (2001); Crosby v. National Foreign Trade Council, 530 
U.S. 363, 372-73 (2000); English v. General Elec. Co., 496 U.S. 72, 
78-79 (1990).
    \323\ See English, 496 U.S. at 79.
    \324\ Freightliner Corp. v. Myrick, 514 U.S. 280, 287 (1995); 
Hines v. Davidowitz, 312 U.S. 52, 67 (1941).
---------------------------------------------------------------------------

    The Act does not expressly state that it preempts any State laws. 
The language of the Act, however, appears to be inconsistent with the 
language of some State laws. For example, the Act sets an expiration 
date for contact lens prescriptions of ``not less than one year after 
the issue date of the prescription if * * * State law specifies * * * a 
date that is less than one year after the issue date.'' \325\ 
Consequently, the Act preempts any State laws that establish a 
prescription expiration date of less than one year.\326\
---------------------------------------------------------------------------

    \325\ See 15 U.S.C. 7604(a)(2).
    \326\ There may be other direct conflicts between the Act and 
State laws, including, for example, State laws conflicting with the 
Act's provision allowing the substitution of equivalent brand 
contact lenses under certain circumstances, and State laws requiring 
written authorization from a patient as a condition of verifying 
contact lens prescription information. To the extent that such State 
laws actually conflict with the Act, they would also be preempted.
---------------------------------------------------------------------------

    In addition, certain State laws regarding prescription release and 
verification requirements appear to be an obstacle to the 
accomplishment of the purposes and objectives of the Act. The Act was 
intended to create ``[a] uniform national standard for prescription 
release and verification * * *.'' \327\ The House committee

[[Page 40506]]

report stated that such a standard would ``best serve the consumer'' 
because it ``promotes competition, consumer choice, and lower prices by 
extending to contact lens wearers the same automatic right to copies of 
their own prescriptions and allows consumers to purchase contact lenses 
from the provider of their choice.\328\
---------------------------------------------------------------------------

    \327\ H. Rep. No. 108-318, at 5 (2003).
    \328\ Id.
---------------------------------------------------------------------------

    The Commission believes that State laws or regulations restricting 
prescription release or requiring ``active'' prescription 
verification--that is, prescribers actually must confirm and verify all 
prescriptions to sellers--would frustrate the purpose of the Act. 
Congress clearly intended to allow consumers greater freedom to choose 
the seller from whom they purchase their contact lenses. To further 
this goal, the Act requires that consumers receive their prescriptions 
at the end of the contact lens fitting process. It also provides that a 
seller may ship if a prescriber has not verified a prescription within 
a defined period of time, thereby preventing prescribers from failing 
to respond to a verification request to preclude consumers from buying 
contact lenses from a different seller. Consequently, the Commission 
concludes that the Act preempts any State laws or regulations that 
restrict prescription release or require active verification, because 
they would undermine Congress's purpose of giving consumers greater 
freedom in their choice of sellers from whom they purchase their 
contact lenses.\329\
---------------------------------------------------------------------------

    \329\ The House Committee that passed the Act reached the same 
conclusion: ``The Committee believes that any State law with an 
active or positive contact lens prescription verification system 
would stand as an obstacle to the accomplishment of the full 
purposes and objectives of this Act. Practically, it would be 
impossible to comply with the terms of this Act and an active 
verification scheme. Therefore, it is the intent of the Committee 
that the passive verification system in section 4(d) preempt any 
conflicting State laws that use active or positive contact lens 
prescription verification systems.'' Id. at 9-10.
---------------------------------------------------------------------------

    Accordingly, the Commission has added part 315.11 to the final Rule 
that explicitly preempts 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. In 
addition, part 315.11 also preempts any other State or local laws or 
regulations that are inconsistent with the Act or this part but only to 
the extent of the inconsistency.

III. Clerical Amendments to the Ophthalmic Practice Rules (16 CFR Part 
456)

    In its NPRM, the Commission also proposed two clerical amendments 
to the Ophthalmic Practice Rules designed to clarify the relationship 
between those Rules and the Contact Lens Rule. First, the Commission 
proposed changing the title of the Ophthalmic Practices Rules to 
``Ophthalmic Practice Rules (Eyeglass Rule).'' Second, the Commission 
proposed adding to the Ophthalmic Practice Rules a cross-reference to 
the Contact Lens Rule, similar to the reference contained in section 
315.1 of the Contact Lens Rule. The Commission received no comments on 
these proposed amendments and adopts them without modification.\330\
---------------------------------------------------------------------------

    \330\ One commenter asked the Commission to add a new provision 
to the Eyeglass Rule which would allow sellers to request eyeglass 
prescriptions from prescribers on behalf of patients. Wal-Mart 
Optical Division (Comment 1070). This suggestion is outside 
the scope of the Contact Lens Rule rulemaking and would constitute a 
substantive change to the Eyeglass Rule requiring a full rulemaking 
proceeding, which the Commission declines to undertake.
---------------------------------------------------------------------------

IV. Paperwork Reduction Act

    In accordance with the Paperwork Reduction Act, as amended, 44 
U.S.C. 3501 et seq. (``PRA''), the Commission submitted the proposed 
Rule to the Office of Management and Budget (``OMB'') for review. The 
OMB has approved the Rule's information collection requirements.\331\ 
The Commission did not receive any comments that necessitated modifying 
its original burden estimates for the Rule's information collection 
requirements.
---------------------------------------------------------------------------

    \331\ The assigned OMB control number is 3084-0127.
---------------------------------------------------------------------------

    Disclosures: As set forth in the NPRM, the Rule imposes certain 
disclosure requirements on contact lens prescribers, as required by the 
Act. Specifically, prescribers must provide a copy of a patient's 
contact lens prescription to the patient or an authorized third party 
upon completion of a contact lens fitting.\332\
---------------------------------------------------------------------------

    \332\ See 69 FR at 5444; see also 15 U.S.C. 7601(a). The 
Commission has retained in the relevant Rule provision as originally 
proposed.
---------------------------------------------------------------------------

    A few commenters confirmed that the Commission estimate of one 
minute is an appropriate estimation of the time it takes prescribers to 
provide a copy of a contact lens prescription to a patient at the 
completion of a contact lens fitting.\333\ The Commission did not 
receive comments on its estimates of the burden of providing a copy of 
the prescription to an authorized third party.
---------------------------------------------------------------------------

    \333\ E.g., American Society for Cataract and Refractive Surgery 
(Comment 1148); Poindexter (Comment 260); E. Lamp, 
O.D. (Comment 714). One commenter noted that the time is 
increased to approximately three (3) minutes, however, if a patient 
subsequently requests another copy of the prescription. Poindexter 
(Comment 260). See also American Society for Cataract and 
Refractive Surgery (Comment 1148) (noting that providing 
subsequent copies of prescriptions will take more than one minute, 
because staff must pull chart, provide to prescriber, prepare 
prescription, etc.). Because the Rule does not require prescribers 
to provide such additional copies, this comment does not necessitate 
modification of the Commission's original burden estimate.
---------------------------------------------------------------------------

    Several commenters--primarily prescribers--stated that responding 
to verification requests from sellers takes more than one minute.\334\ 
Some of these commenters noted that the verification process may entail 
a number of steps, including answering the telephone, recording the 
verification request information, pulling the patient's chart, 
providing the information to the prescriber, reviewing the information 
and making a decision about the request, communicating information to 
the seller, and refiling the chart.\335\
---------------------------------------------------------------------------

    \334\ E.g., Tupelo Eye Clinic/Chappell (Comment 11) 
(suggesting amending the Commission's cost factor to more accurately 
reflect the true cost, but not providing alternate time estimate); 
W. West (Comment 126) (estimating one minute of prescriber 
and five minutes of staff time); Staff (Comment 131); 
American Society for Cataract and Refractive Surgery (Comment 
1148); E. Lamp, O.D. (Comment 714) (estimating one 
minute for staff and one minute for prescriber for each verification 
request); H.G. Schneider, M.D. (Comment 1006) (estimating 
minimum of 20 minutes for telephone verification); S. Renner, O.D. 
(Comment 850) (estimating 45 minutes to deal with automated 
verification request).
    \335\ E.g., Tupelo Eye Clinic/Chappell (Comment 11); 
American Society for Cataract and Refractive Surgery (Comment 
1148).
---------------------------------------------------------------------------

    Responding to a verification request does not impose a paperwork 
burden under the PRA, however, because the Rule does not require the 
prescriber to provide information to a third party. Rather, under the 
Rule, the prescriber determines whether to respond to a verification 
request, and, if so, what information to provide to the seller. If, for 
example, the prescription information contained in a verification 
request is not expired, inaccurate or otherwise invalid, the prescriber 
need not respond at all. Thus, depending on the particular 
circumstances of a particular verification request, the prescriber may 
or may not disclose information. Accordingly, these comments do not 
necessitate revising the Commission's original burden estimate.
    Recordkeeping: The proposed Rule also would impose recordkeeping 
requirements on both prescribers and sellers. Prescribers, as required 
by the Act, must document in their patients'

[[Page 40507]]

records the medical reasons for setting a contact lens prescription 
expiration date of less than one year.\336\ The Commission did not 
receive any comments on its burden estimates for this requirement.
---------------------------------------------------------------------------

    \336\ See 69 FR at 5444; see also 15 U.S.C. 7604(b)(1).
---------------------------------------------------------------------------

    Contact lens sellers must maintain records for three years of all 
direct communications involved in obtaining verification of a contact 
lens prescription, as well as prescriptions, or copies thereof, which 
they receive directly from consumers or prescribers.\337\ One contact 
lens seller asked the Commission to specify in the Rule that an 
electronic entry--in lieu of maintaining actual telephone bills--would 
satisfy the requirement that sellers maintain records of direct 
communication occurring via telephone.\338\ The Commission already has 
deleted from the final Rule the requirement that sellers maintain 
telephone bills, and clarified that electronic storage of telephone log 
information is permitted. Accordingly, this comment does not 
necessitate an increase in the Commission's original burden 
estimate.\339\
---------------------------------------------------------------------------

    \337\ See 69 FR at 5444; see also 15 U.S.C. 7603(b).
    \338\ Wal-Mart Optical Division (Comment 1070). Wal-
Mart did not specifically invoke the Commission's PRA estimates, but 
commented generally on the recordkeeping provisions of the proposed 
Rule. Nonetheless, the Commission has considered these comments as 
relevant to its PRA estimates.
    \339\ As discussed supra, the new provision in the final rule, 
that concerns recordkeeping for those sellers who choose to count a 
prescriber's regular Saturday business hours in the eight hour 
verification period, is not a substantive or material modification 
to the collection of information.
---------------------------------------------------------------------------

V. Regulatory Flexibility Act

    The Regulatory Flexibility Act (``RFA''), 5 U.S.C. 601-612, 
requires an agency to provide an Initial Regulatory Flexibility 
Analysis (``IRFA'') with a proposed rule and a Final Regulatory 
Flexibility Analysis (``FRFA'') with the final rule, if any, unless the 
agency certifies that the rule will not have a significant economic 
impact on a substantial number of small entities. See 5 U.S.C. 603-605.
    In its NPRM, the Commission stated its expectation that the 
proposed Rule would not have a significant economic impact on a 
substantial number of small entities.\340\ The Commission noted that 
the Act \341\ expressly mandates most, if not all, of the Rule's 
requirements. It thus accounts for most, if not all, of the economic 
impact of the proposed Rule.\342\ Further, the Commission estimated 
that the burdens most likely to be imposed on small entities (such as 
many contact lens prescribers) were likely to be relatively small: 
providing contact lens prescriptions to patients or their agents, 
recording the medical reasons for setting prescription expiration dates 
of less than one year, and verifying prescription information.\343\ 
Finally, the Commission estimated that the Rule's more significant 
recordkeeping burdens likely would fall primarily on larger sellers of 
contact lenses, the entities more likely to seek verification of 
prescriptions and thus trigger those requirements.\344\
---------------------------------------------------------------------------

    \340\ See 69 FR at 5445.
    \341\ 15 U.S.C. 7601-7610.
    \342\ See 59 FR at 5445.
    \343\ Id.
    \344\ Id.
---------------------------------------------------------------------------

    For those reasons, the Commission deemed the NPRM as notice to the 
Small Business Administration of the agency's certification of no 
effect.\345\ Nonetheless, the Commission determined that it was 
appropriate to publish an IRFA in order to inquire into the impact of 
the proposed Rule on small entities. Having received only a small 
number of comments on the IRFA, the Commission has prepared the 
following FRFA, and confirms its certification of no effect.
---------------------------------------------------------------------------

    \345\ Id.
---------------------------------------------------------------------------

A. Need for and Objectives of the Final Rule

    The Act directs the Commission to prescribe rules implementing the 
Act not later than 180 days after the Act takes effect on February 4, 
2004.\346\ Accordingly, the Commission issued a proposed Contact Lens 
Rule on February 4, 2004, and announces its final Rule in this 
document. The objectives of the Rule are to implement the Act and 
effectuate its intent to provide for the availability of contact lens 
prescriptions to consumers.
---------------------------------------------------------------------------

    \346\ 15 U.S.C. 7607.
---------------------------------------------------------------------------

B. Significant Issues Raised by Public Comments, Summary of Agency's 
Assessment of These Issues, and Changes, If Any, Made in Response

    The Commission received very few comments on its IRFA. These 
comments generally challenged the Commission's expectation that the Act 
and Rule will not have a significant economic impact on a substantial 
number of small entities. One comment stated that, ``[w]hile we agree 
that most of these burdens are mandated by the Act, they will 
nonetheless be quite substantial,'' and, as the Commission acknowledged 
in its NPRM, ``most of the prescribers affected by this statute will be 
small entities.'' \347\ In particular, the comments argued that the 
burden imposed on small entities by the Act's verification requirement 
is substantial, as responding to verification requests takes 
significant time and many prescribers receive multiple requests per 
day.\348\ To reduce this burden, one comment suggested that the Rule 
limit the number of verifications and prescription releases that small 
business prescribers must perform for a particular customer.\349\
---------------------------------------------------------------------------

    \347\ American Society for Cataract and Refractive Surgery 
(Comment 1148).
    \348\ American Academy of Ophthalmology (Comment 1057) 
(stating that responding to a high volume of requests requires 
significant resources, assuming five minutes per request); American 
Society for Cataract and Refractive Surgery (Comment 1148) 
(burden of verifying likely to be substantial).
    \349\ K. Poindexter (Comment 260).
---------------------------------------------------------------------------

    The Commission recognizes the Rule imposes burdens on small 
entities, and the Commission has addressed some of these burdens in the 
context of the Paperwork Reduction Act in above. However, these burdens 
are mandated by the Act. Moreover, some of these burdens are minimal, 
relative to prescribers' overall business costs. For example, the 
Commission has estimated--and commenters agree--that prescription 
release will require approximately one minute per patient, and that 
documenting medical reasons for setting prescription expiration dates 
shorter than one year likely already occurs in the ordinary course of 
business. The obligation to verify prescriptions imposes more burden, 
but the evidence in the record suggests it also is relatively small as 
compared to overall business costs: although one commenter indicated 
that some prescribers receive multiple verification requests per day, 
other evidence in the record suggests that prescribers receive, on 
average, just under two (2) verification requests per week--a 
significantly smaller burden.\350\
---------------------------------------------------------------------------

    \350\ See American Academy of Ophthalmology (Comment 
1057) (up to 10 per day is not uncommon); 1-800 CONTACTS 
(Comment 1140) at 55.
---------------------------------------------------------------------------

    Furthermore, as discussed earlier, the Commission has made certain 
revisions in the final Rule to reduce the burdens on businesses 
regardless of size--e.g., permitting electronic recordkeeping of 
certain direct communications and eliminating the proposed requirement 
to maintain telephone bills. In addition, the final Rule permits some 
limitation on prescription release and verification. For example, the 
Commission has indicated that the Rule does not require prescribers to 
provide additional copies of prescriptions to patients after the 
initial release upon completion of a contact lens fitting, although the 
Rule

[[Page 40508]]

does not prohibit this practice either.\351\ Moreover, the Commission 
expects that, in time, as prescribers and sellers gain experience in 
the verification process and become more efficient, the burdens imposed 
on small businesses will decrease. Accordingly, the Commission does not 
believe the burdens imposed by the Rule on small entities are 
significant, and has not made any changes to the Rule in response to 
the comments received on its IRFA.
---------------------------------------------------------------------------

    \351\ See discussion of section 315.5, supra.
---------------------------------------------------------------------------

C. Description and an Estimate of the Number of Small Entities to Which 
the Final Rule Will Apply, or Explanation Why No Estimate Is Available

    The Rule applies to both ``prescribers'' and ``sellers'' of contact 
lenses. As stated in the NPRM,\352\ the Commission staff believes that 
many prescribers will fall into the category of small entities (e.g., 
Offices of Optometrists less than $6 million in size), but that, for 
the most part, sellers subject to the Rule's recordkeeping requirements 
likely will be larger businesses.\353\ Determining a precise estimate 
of the number of small entities covered by the Rule's disclosure and 
recordkeeping requirements is not readily feasible, and the Commission 
did not receive comments providing this information. However, the 
Commission generally estimates that the Rule will affect approximately 
50,000 prescribers, many of whom are likely to be small businesses; 
some comments confirm that the Rule will likely impact a large number 
of small businesses.\354\
---------------------------------------------------------------------------

    \352\ See 69 FR at 5445.
    \353\ See 12 CFR Part 121.201 (Small Business Administration's 
Table of Small Business Size Standards).
    \354\ E.g., American Society for Cataract and Refractive Surgery 
(Comment 1148); American Academy of Ophthalmology (Comment 
1057) (approximately 40% of AAO members are solo 
practitioners with very small staffs).
---------------------------------------------------------------------------

D. Description of the Projected Reporting, Recordkeeping, and Other 
Compliance Requirements of the Final Rule, Including an Estimate of the 
Classes of Small Entities That Will Be Subject to the Requirements, and 
the Type of Professional Skills That Will Be Necessary To Comply

    As mandated by the Act, the Rule imposes disclosure and 
recordkeeping requirements, within the meaning of the Paperwork 
Reduction Act, on contact lens prescribers and sellers. With respect to 
disclosure, section 315.3(a) the Rule requires prescribers to provide 
patients with a copy of their contact lens prescription upon completion 
of a contact lens fitting, and to provide such prescriptions to third 
parties authorized to act on behalf of patients.
    The Rule also implements several recordkeeping requirements. First, 
if a prescriber sets a contact lens prescription expiration date 
shorter than one year, section 315.6(b) of the Rule requires the 
prescriber to document the medical reasons justifying the shorter 
expiration date and maintain that record for three years. Second, 
section 315.5(g) of the Rule requires sellers to maintain records of 
all direct communications relating to prescription verification. The 
specific records a seller must retain vary depending on the manner of 
communication.
    The Commission has obtained clearance from the Office of Management 
and Budget (``OMB'') for these requirements.\355\ The Commission staff 
estimated that the proposed Rule's disclosure and recordkeeping 
requirements referenced above would impose an average annual burden of 
600,000 hours on prescribers--primarily consisting of time spent by 
prescribers writing and providing prescriptions to their patients--for 
a total annual labor cost of $25.2 million. For sellers, the staff 
estimated that the proposed Rule would impose an average annual burden 
of 300,000 hours--primarily consisting of time spent by clerical staff 
performing recordkeeping--for a total annual labor cost of $3 million.
---------------------------------------------------------------------------

    \355\ The assigned OMB clearance number is 3084-0127.
---------------------------------------------------------------------------

E. Steps the Agency Has Taken in the Final Rule To Minimize any 
Significant Economic Impact of the Final Rule on Small Entities, 
Consistent With Applicable Statutory Objectives, Including the Factual 
and Legal Bases for the Alternatives Adopted and Those Rejected

    The final Rule's disclosure and recordkeeping requirements are 
designed to impose the minimum burden on all affected members of the 
industry, regardless of size. The Act itself does not allow the 
Commission any latitude to treat small businesses differently, such as 
by exempting a particular category of firm or setting forth a lesser 
standard of compliance for any category of firm. Thus, although the 
Commission recognizes that the Rule imposes some burden on small 
entities, it does not believe the burden will be significant, and, in 
any event, the Commission is largely constrained by the fact that the 
Act mandates those burdens.
    Nonetheless, the Commission has indicated above that the Rule 
permits some limitation on prescription release and verification by 
prescribers. Moreover, in time, as prescribers and sellers gain 
experience and efficiency in the verification process, the Commission 
expects that the burdens imposed on small businesses will decrease. 
Accordingly, the Commission confirms its initial certification of no 
effect.

VI. Final Rule

List of Subjects in 16 CFR Parts 315 and 456

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

0
Accordingly, for the reasons stated in the preamble, the Federal Trade 
Commission amends 16 CFR chapter I as follows:
0
1. Add a new part 315 to read as follows:

PART 315--CONTACT LENS RULE

Sec.
315.1 Scope of regulations in this part.
315.2 Definitions.
315.3 Availability of contact lens prescriptions to patients.
315.4 Limits on requiring immediate payment.
315.5 Prescriber verification.
315.6 Expiration of contact lens prescriptions.
315.7 Content of advertisements and other representations.
315.8 Prohibition of certain waivers.
315.9 Enforcement.
315.10 Severability.
315.11 Effect on state and local laws.

    Authority: Pub. L. 108-164, secs. 1-12; 117 Stat. 2024 (15 
U.S.C. 7601-7610).


Sec.  315.1  Scope of regulations in this part.

    This part, which shall be called the ``Contact Lens Rule,'' 
implements the Fairness to Contact Lens Consumers Act, codified at 15 
U.S.C. 7601-7610, which requires that rules be issued to address the 
release, verification, and sale of contact lens prescriptions. This 
part specifically governs contact lens prescriptions and related 
issues. Part 456 of Title 16 governs the availability of eyeglass 
prescriptions and related issues (the Ophthalmic Practice Rules 
(Eyeglass Rule)).


Sec.  315.2  Definitions.

    For purposes of this part, the following definitions shall apply:
    Business hour means an hour between 9 a.m. and 5 p.m., during a 
weekday (Monday through Friday), excluding Federal holidays. ``Business 
hour'' also may include, at the seller's option, a prescriber's regular 
business hours on Saturdays, provided that the seller has actual 
knowledge of these hours.

[[Page 40509]]

``Business hour'' shall be determined based on the time zone of the 
prescriber.
    ``Eight (8) business hours'' shall be calculated from the time the 
prescriber receives the prescription verification information from the 
seller, and shall conclude when eight (8) business hours have elapsed. 
For verification requests received by a prescriber during non-business 
hours, the calculation of ``eight (8) business hours'' shall begin at 9 
a.m. on the next weekday that is not a Federal holiday or, if 
applicable, on Saturday at the beginning of the prescriber's actual 
business hours.
    Commission means the Federal Trade Commission.
    Contact lens means any contact lens for which State or Federal law 
requires a prescription.
    Contact lens fitting means the process that begins after an initial 
eye examination for contact lenses and ends when a successful fit has 
been achieved or, in the case of a renewal prescription, ends when the 
prescriber determines that no change in the existing prescription is 
required, and such term may include:
    (1) An examination to determine lens specifications;
    (2) Except in the case of a renewal of a contact lens prescription, 
an initial evaluation of the fit of the contact lens on the eye; and
    (3) Medically necessary follow-up examinations.
    Contact lens prescription means a prescription, issued in 
accordance with State and Federal law, that contains sufficient 
information for the complete and accurate filling of a prescription for 
contact lenses, including the following:
    (1) The name of the patient;
    (2) The date of examination;
    (3) The issue date and expiration date of prescription;
    (4) The name, postal address, telephone number, and facsimile 
telephone number of prescriber;
    (5) The power, material or manufacturer or both of the prescribed 
contact lens;
    (6) The base curve or appropriate designation of the prescribed 
contact lens;
    (7) The diameter, when appropriate, of the prescribed contact lens; 
and
    (8) 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.
    Direct communication means completed communication by telephone, 
facsimile, or electronic mail.
    Issue date means the date on which the patient receives a copy of 
the prescription at the completion of a contact lens fitting.
    Ophthalmic goods are contact lenses, eyeglasses, or any component 
of eyeglasses.
    Ophthalmic services are the measuring, fitting, and adjusting of 
ophthalmic goods subsequent to an eye examination.
    Prescriber means, with respect to contact lens prescriptions, 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,'' for purposes of this definition, 
includes a dispensing optician who is permitted under State law to 
issue prescriptions and who is authorized or permitted under State law 
to perform contact lens fitting services.
    Private label contact lenses mean 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.


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; and
    (2) Shall, as directed by any person designated to act on behalf of 
the patient, provide or verify the contact lens prescription by 
electronic or other means.
    (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)(2) 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)(2) 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) or 
(a)(2) of this section.


Sec.  315.4  Limits on requiring immediate payment.

    A prescriber may require payment of fees for an eye examination, 
fitting, and evaluation before the release of a contact lens 
prescription, but only if the prescriber requires immediate payment in 
the case of an examination that reveals no requirement for ophthalmic 
goods. For purposes of the preceding sentence, presentation of proof of 
insurance coverage for that service shall be deemed to be a payment.


Sec.  315.5  Prescriber verification.

    (a) Prescription requirement. A seller may sell contact lenses only 
in accordance with a contact lens prescription for the patient that is:
    (1) Presented to the seller by the patient or prescriber directly 
or by facsimile; or
    (2) Verified by direct communication.
    (b) Information for verification. When seeking verification of a 
contact lens prescription, a seller shall provide the prescriber with 
the following information through direct communication:
    (1) The patient's full name and address;
    (2) The contact lens power, manufacturer, base curve or appropriate 
designation, and diameter when appropriate;
    (3) The quantity of lenses ordered;
    (4) The date of patient request;
    (5) The date and time of verification request;
    (6) The name of a contact person at the seller's company, including 
facsimile and telephone numbers; and
    (7) If the seller opts to include the prescriber's regular business 
hours on Saturdays as ``business hours'' for purposes of paragraph 
(c)(3) of this section, a clear statement of the prescriber's regular 
Saturday business hours.
    (c) Verification events. A prescription is verified under paragraph 
(a)(2) of this section only if one of the following occurs:
    (1) The prescriber confirms the prescription is accurate by direct 
communication with the seller;
    (2) The prescriber informs the seller through direct communication 
that the prescription is inaccurate and provides the accurate 
prescription; or
    (3) The prescriber fails to communicate with the seller within 
eight (8) business hours after receiving from the seller the 
information described in paragraph (b) of this section. During these 
eight (8) business hours, the seller shall provide a reasonable 
opportunity for the prescriber to communicate with the seller 
concerning the verification request.
    (d) Invalid prescription. If a prescriber informs a seller before 
the deadline

[[Page 40510]]

under paragraph (c)(3) of this section that the contact lens 
prescription is inaccurate, expired, or otherwise invalid, the seller 
shall not fill the prescription. The prescriber shall specify the basis 
for the inaccuracy or invalidity of the prescription. If the 
prescription communicated by the seller to the prescriber is 
inaccurate, the prescriber shall correct it, and the prescription shall 
then be deemed verified under paragraph (c)(2) of this section.
    (e) No alteration of prescription. A seller may not alter a contact 
lens prescription. Notwithstanding the preceding sentence, 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.
    (f) Recordkeeping requirement--verification requests. A seller 
shall maintain a record of all direct communications referred to in 
paragraph (a) of this section. Such record shall consist of the 
following:
    (1) For prescriptions presented to the seller: the prescription 
itself, or the facsimile version thereof (including an email containing 
a digital image of the prescription), that was presented to the seller 
by the patient or prescriber.
    (2) For verification requests by the seller:
    (i) If the communication occurs via facsimile or e-mail, a copy of 
the verification request, including the information provided to the 
prescriber pursuant to paragraph (b) of this section, and confirmation 
of the completed transmission thereof, including a record of the date 
and time the request was made;
    (ii) If the communication occurs via telephone, a log:
    (A) Describing the information provided pursuant to paragraph (b) 
of this section,
    (B) Setting forth the date and time the request was made,
    (C) Indicating how the call was completed, and
    (D) Listing the names of the individuals who participated in the 
call.
    (3) For communications from the prescriber, including prescription 
verifications:
    (i) If the communication occurs via facsimile or e-mail, a copy of 
the communication and a record of the time and date it was received;
    (ii) If the communication occurs via telephone, a log describing 
the information communicated, the date and time that the information 
was received, and the names of the individuals who participated in the 
call.
    (4) The records required to be maintained under this section 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.
    (g) 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 verification specified in 
Sec. 315.5(c)(3) 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.


Sec.  315.6  Expiration of contact lens prescriptions.

    (a) In general. A contact lens prescription shall expire:
    (1) 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;
    (2) Not less than one year after the issue date of the prescription 
if such State law specifies no date or specifies a date that is less 
than one year after the issue date of the prescription; or
    (3) Notwithstanding paragraphs (a)(1) and (a)(2) of this section, 
on the date specified by the prescriber, if that date is based on the 
medical judgment of the prescriber with respect to the ocular health of 
the patient.
    (b) Special rules for prescriptions of less than one year.
    (1) If a prescription expires in less than one year, the specific 
reasons for the medical judgment referred to in paragraph (a)(3) of 
this section shall be documented in the patient's medical record with 
sufficient detail to allow for review by a qualified professional in 
the field.
    (2) The documentation described in the paragraph above shall be 
maintained for a period of not less than three years, and it must be 
available for inspection by the Federal Trade Commission, its 
employees, and its representatives.
    (3) No prescriber shall include an expiration date on a 
prescription that is less than the period of time that he or she 
recommends for a reexamination of the patient that is medically 
necessary.


Sec.  315.7  Content of advertisements and other representations.

    Any person who engages in the manufacture, processing, assembly, 
sale, offering for sale, or distribution of contact lenses may not 
represent, by advertisement, sales presentation, or otherwise, that 
contact lenses may be obtained without a prescription.


Sec.  315.8  Prohibition of certain waivers.

    A prescriber may not place on a prescription, or require the 
patient to sign, or deliver to the patient, a form or notice waiving or 
disclaiming the liability or responsibility of the prescriber for the 
accuracy of the eye examination. The preceding sentence does not impose 
liability on a prescriber for the ophthalmic goods and services 
dispensed by another seller pursuant to the prescriber's correctly 
verified prescription.


Sec.  315.9  Enforcement.

    Any violation of this Rule shall be treated as a violation of a 
rule under section 18 of the Federal Trade Commission Act, 15 U.S.C. 
57a, regarding unfair or deceptive acts or practices, and the 
Commission will enforce this Rule in the same manner, by the same 
means, and with the same jurisdiction, powers, and duties as are 
available to it pursuant to the Federal Trade Commission Act, 15 U.S.C. 
41 et seq.


Sec.  315.10  Severability.

    The provisions of this part are separate and severable from one 
another. If any provision is stayed or determined to be invalid, it is 
the Commission's intention that the remaining provisions shall continue 
in effect.


Sec.  315.11  Effect on state and local laws.

    (a) 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 are preempted.
    (b) Any other State or local laws or regulations that are 
inconsistent with the Act or this part are preempted to the extent of 
the inconsistency.

PART 456--[AMENDED]

0
2. The authority citation for part 456 continues to read as follows:

    Authority: 15 U.S.C. 57a; 5 U.S.C. 552.

0
3. Revise the title of part 456 to read as follows:

PART 456--OPHTHALMIC PRACTICE RULES (EYEGLASS RULE)

0
4. Add a new Sec.  456.5 to read as follows:

[[Page 40511]]

Sec.  456.5  Rules applicable to prescriptions for contact lenses and 
related issues.

    Rules applicable to prescriptions for contact lenses and related 
issues may be found at 16 CFR part 315 (Contact Lens Rule).

By direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. 04-14969 Filed 7-1-04; 8:45 am]
BILLING CODE 6750-01-P