[Federal Register Volume 62, Number 64 (Thursday, April 3, 1997)]
[Proposed Rules]
[Pages 15865-15867]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-8494]


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FEDERAL TRADE COMMISSION

16 CFR Part 456


Ophthalmic Practice Rules: Request for Comments

AGENCY: Federal Trade Commission.

ACTION: Request for public comments.

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SUMMARY: The Federal Trade Commission (the ``Commission'') is 
requesting public comments on its Trade Regulation Rule entitled 
Ophthalmic Practice Rules, which requires eye care practitioners to 
release eyeglass prescriptions to their patients (``Prescription 
Release Rule''), 16 CFR Part 456. The Commission is soliciting comments 
about the overall costs and benefits of the rule and its overall 
regulatory and economic impact as part of its systematic review of all 
current Commission regulations and guides. The Commission is further 
requesting comment on several issues relating to specific provisions of 
the rule. All interested persons are hereby given notice of the 
opportunity to submit written data, views, and arguments concerning the 
rule.

DATES: Written comments must be submitted on or before June 2, 1997.

ADDRESSES: Written comments should be identified as ``16 CFR Part 456 
Comment'' and sent to Secretary, Federal Trade Commission, Room 159, 
Washington, DC 20580.

FOR FURTHER INFORMATION CONTACT:
Renee Kinscheck, Attorney, Federal Trade Commission, Bureau of Consumer 
Protection, Washington, DC 20580, (202) 326-3283; Federal Trade 
Commission, room 200, Washington, DC 20580; e-mail address: 
RK[email protected].

SUPPLEMENTARY INFORMATION: The Commission has determined, as part of 
its oversight responsibilities, to review rules and guides 
periodically. These reviews will seek information about the costs and 
benefits of the Commission's rules and guides and their regulatory and 
economic impact. The information obtained will assist the Commission in 
identifying rules and guides that warrant modification or rescission. 
The Commission is also seeking comment on several issues specific to 
the Prescription Release Rule, including: whether the Commission should 
modify or eliminate the prescription release requirement; whether, if 
it is retained, this provision should be changed to require that an 
eyeglass prescription be given to a patient only if the patient 
requests it, rather than in every instance, or whether this provision 
should be modified in some other way; and whether any changes should be 
made to Sec. 456.2(d)'s prohibition on the use of certain waivers or 
disclaimers of liability. The Commission seeks comment on the costs and 
benefits of such proposed changes.

Part A--Background Information

    The Commission promulgated the Prescription Release Rule in 1978 
based on a finding that many consumers were being deterred from 
comparison shopping for eyeglasses because eye care practitioners 
refused to release prescriptions, even when requested to do so, or 
charged an additional fee for release of a prescription.\1\
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    \1\ Advertising of Ophthalmic Goods and Services, Statement of 
Basis and Purpose and Final Trade Regulation Rule, 43 FR 23992, 
23998 (June 2, 1978) (hereinafter ``1978 Statement of Basis and 
Purpose''). In addition, the Commission found that some 
practitioners refused to conduct an examination unless the patient 
agreed to purchase eyeglasses from the practitioner or included 
potentially intimidating disclaimers of liability on the 
prescription itself. Id.

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[[Page 15866]]

    The rule requires an optometrist or ophthalmologist to provide the 
patient with a copy of the patient's eyeglass prescription immediately 
after the eye examination is completed at no extra cost.\2\ (Sec. 456.2 
(a) and (c).) It also prohibits optometrists and ophthalmologists from 
conditioning the availability of an eye examination, as defined in the 
rule, on a requirement that the patient agrees to purchase ophthalmic 
goods from the optometrist or ophthalmologist. (Sec. 456.2(b).)
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    \2\ An optometrist or ophthalmologist, however, may withhold the 
eyeglass prescription if the patient has not paid for the eye 
examination in full if the optometrist or ophthalmologist would have 
required immediate payment if the examination revealed that no 
ophthalmic goods, such as eyeglasses, were required.
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    In Sec. 456.2(d) the rule prohibits placing on the prescription, or 
delivering to the patient, any waiver or disclaimer of the liability of 
the practitioner for the accuracy of the eye examination or the 
accuracy of the ophthalmic goods and services dispensed by another 
seller. As the Commission made clear in its declaration of intent 
(Sec. 456.4), the rule does not impose liability on an ophthalmologist 
or optometrist for the ophthalmic goods and services dispensed by 
another seller pursuant to the ophthalmologist's or optometrist's 
prescription. By its terms, the rule proscribes only ``waivers or 
disclaimers'' of responsibility. The Commission has interpreted this 
portion of the rule to permit nondeceptive affirmative statements 
concerning responsibility. For example, a written statement that ``the 
person who dispenses your eyeglasses is responsible for their 
accuracy'' would not violate Sec. 456.2(d). However, such an 
affirmative statement cannot be coupled with a waiver or disclaimer of 
the optometrist's or ophthalmologist's own liability.\3\
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    \3\ Trade Regulation Rule; Ophthalmic Practice Rules, Final 
Trade Regulation Rule, 54 FR 10285, 10299 (March 13, 1989) 
(hereinafter ``1989 Statement of Basis and Purpose''). The 
Commission's interpretation of this provision was originally set 
forth at 43 FR 46296-46297 (October 6, 1978).
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    The rule requires eye care practitioners to release copies of the 
eyeglass prescriptions regardless of whether or not the patient 
requests the prescription. The Commission promulgated this automatic 
release requirement based on a finding of ``consumers' lack of 
awareness that the purchase of eyeglasses need not be a unitary 
process''--i.e., the purchasing eyeglasses can be separated from the 
process of obtaining an eye exam. The automatic release provision was 
thus imposed as a remedial measure.\4\
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    \4\ Statement of Basis and Purpose, 54 FR at 10302, citing, 
Ophthalmic Practice Rules, State Restrictions on Commercial 
Practice, ``Eyeglasses II,'' Report of the Staff of the Federal 
Trade Commission, October 1986, at pp. 251-52.
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    In 1985, the Commission published a Notice of Proposed Rulemaking 
(hereinafter ``NPR'') that invited comments on whether the prescription 
release requirement should be modified or repealed. Specifically, among 
other questions, the Commission asked whether: (1) the rule should be 
modified to require that eyeglass prescriptions be given to patients 
only in those instances where patients request them; (2) the rule 
should be modified to require eye care practitioners only to offer, 
rather than automatically give, eyeglass prescriptions to their 
patients; or (3) the rule should be extended to require the release of 
contact lens prescriptions.\5\
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    \5\ Ophthalmic Practice Rules; Proposed Trade Regulation Rule; 
Notice of Proposed Rulemaking, 50 FR 598, 602-03 (January 4, 1985). 
The Commission also asked whether: (1) the rule should be repealed 
altogether; (2) the rule should be extended to require optometrists 
and ophthalmologists to provide a duplicate copy of a prescription 
to a patient who lost or misplaced the original; and (3) the rule 
should require dispensers to return the prescription after filling 
the prescription. Id.
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    In 1989, having considered the rulemaking record, which included 
two surveys and comments and testimony offered by optometrists, 
opticians, professional associations, state boards, and consumer 
groups, the Commission decided to retain the automatic release aspect 
of the rule. In declining to modify the rule, the Commission stated 
that there was still significant non-compliance with the automatic 
release requirement and that there continued to be a lack of consumer 
awareness about prescription rights. Accordingly, the Commission held 
that it could not conclude that the remedial automatic release 
provision was no longer needed.\6\
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    \6\ 1989 Statement of Basis and Purpose, 54 FR at 10303. The 
Commission did modify the definition of ``prescription'' to 
eliminate confusion. This term was, and is, defined as those 
specifications necessary to obtain lenses for eyeglasses. Thus, 
under the rule, the prescription that is released to the patient 
need only contain the data on the refractive status of the patient's 
eyes and any information, such as the date or signature of the 
examining optometrist or ophthalmologist, that state law requires in 
a legally fillable eyeglasses prescription. In 1989, the Commission 
deleted from the definition all references to contact lenses. This 
change was intended to end the confusion generated by the prior 
definition concerning the obligation of optometrists and 
ophthalmologists to place the phrase ``OK for contact lenses'' (or 
similar words) on prescriptions. No such obligation exists under the 
rule. 1989 Statement of Basis and Purpose, 54 FR at 10299. The 
change also helped to eliminate confusion over whether the rule 
requires the release of a contact lens prescription.
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    The Commission also determined not to extend the Prescription 
Release Rule to contact lens prescriptions. In making its decision, the 
Commission concluded that there was not sufficient reliable evidence on 
the record to permit a conclusion that the practice not to release 
contact lens prescriptions was prevalent. The Commission further 
commented that even if the evidence on the prevalence of refusal to 
release contact lens prescriptions, and any resulting consumer injury, 
were satisfactorily documented, the Commission would need to consider 
if any countervailing benefits justified the refusal. The Commission 
noted in its Statement of Basis and Purpose that some commenters 
suggested that refusal to release contact lens prescriptions is 
necessary to permit the fitter to verify the fit of the lens because 
there is some danger that the lenses may not conform to the eye as 
expected. The Commission then stated that because the evidence was 
insufficient to evaluate this claim fully, it could not reach a 
conclusion that the refusal to release a contact lens prescription in 
an unfair act or practice.\7\
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    \7\ 1989 Statement of Basis and Purpose, 54 FR at 10303. With 
respect to the other questions raised in the NPR, the Commission 
concluded that there was no substantial evidence to show either that 
practitioners refused to release duplicate copies of prescriptions 
to patients who lost or misplaced their original copies or that 
eyeglass dispensers refused to return prescriptions to patients 
after filling the prescription. Thus, it concluded that rulemaking 
in these areas would be inappropriate. Id.
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    The Commission revisited the contact lens prescription release 
issue in 1995, in response to a petition for rulemaking by a consumer 
in South Carolina whose optometrist had refused to release the 
consumer's contact lens prescription. Although the petitioner did not 
provide any information or documentation suggesting that the evidence 
considered by the Commission during the previous rulemaking proceeding 
had changed in any way, the Commission, in February 1995, conducted a 
survey on the extent of contact lens consumers' ability to obtain their 
contact lens prescriptions.\8\
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    \8\ The survey consisted of telephone interviews of 2037 
consumers selected from a random digit dialing probability sample of 
all households in the United States. These consumers were initially 
asked whether they had worn contact lenses within the past year. Two 
hundred and fifty of the 2037 consumers contacted by interviewers 
(approximately 10.5%) had worn contact lenses within the past year. 
These consumers were asked the remaining questions in the survey 
concerning their ability to obtain their contact lens prescription.

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[[Page 15867]]

    The survey results suggest that most consumers obtain a copy of 
their contact lens prescription. Approximately 60% (147/250) of those 
interviewees did receive a copy of their contact lens prescription 
either immediately after their last exam or subsequently thereafter. 
Moreover, the survey results indicate that nearly all practitioners who 
are requested to release the contact lens prescription to the consumer, 
do so. Approximately 92% (66/72) of those consumers who requested a 
copy of their contact lens prescription received the prescription 
either immediately after the eye examination or subsequently 
thereafter.\9\
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    \9\ This survey has been placed on the public record, and is 
available from the Commission's Public Reference Branch, Room, 130, 
Washington, DC 20580; 202-326-2222; TTY for the hearing impaired 
202-326-2502.
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    Based on the results of the survey as well as the existence of 
industry literature continuing to raise quality of care issues relating 
to unsupervised use of contact lenses, the Commission denied the 
petition.\10\
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    \10\ The petition and the Commission's response have been placed 
on the public record, and are available from the Commission's Public 
Reference Branch, Room 130, Washington, DC 20580; 202-326-2222; TTY 
for the hearing impaired 202-326-2502.
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Part B--Issues for Comments

    The Commission solicits written public comments on the following 
questions:
    1. Is there a continuing need for the rule?
    a. What benefits has the rule provided to purchasers of eye exams 
and eyeglasses, to opticians or to others affected by the rule?
    b. Has the rule imposed costs on purchasers?
    2. What changes, if any, should be made to the rule to increase the 
benefits of the rule to purchasers, opticians or to others?
    a. How would these changes affect the costs the rule imposes on eye 
care practitioners (optometrists and ophthalmologists) subject to its 
requirements?
    3. What significant burdens or costs, including costs of 
compliance, has the rule imposed on eye care practitioners?
    a. Has the rule provided benefits to such practitioners?
    4. What changes, if any, should be made to the rule to reduce the 
burdens or costs imposed on eye care practitioners?
    a. How would these changes affect the benefits provided by the 
rule?
    5. Does the rule overlap or conflict with other federal, state, or 
local laws or regulations?
    6. Since the rule was issued, what effects, if any, have changes in 
relevant technology or economic conditions had on the rule?

Section 456.2(a)--Prescription Release Requirement

    7. If the rule is retained, should the Commission modify the 
prescription release requirement of Sec. 456.2(a) to require that an 
eyeglass prescription be given to a patient only if the patient 
requests it, rather than in every instance, or should this provision be 
modified in some other way?
    a. Are consumers generally aware of their ability to seek and 
obtain their eyeglass prescriptions?
    b. To what extent are consumers able to obtain a copy of their 
eyeglass prescription if they request one?
    c. To what extent would practitioners release eyeglass 
prescriptions in the absence of any federal requirement to do so?

Section 456.2(d)--Waivers and Disclaimers

    8. Should any changes be made to Sec. 456.2(d)'s prohibition on the 
use of certain waivers or disclaimers of liability, and/or the 
Commission interpretation thereof?
    a. What problems, if any, has the current requirement, and/or its 
interpretation, caused?
    b. How could any such problems be remedied?

Contact Lens Prescriptions

    9. Should the rule be extended to require the release of contact 
lens prescriptions?
    a. Are consumers able to get their contact lens prescriptions upon 
request?
    b. What evidence is there to show that refusal to release contact 
lens prescriptions does or does not have benefits justifying the 
refusal? Specifically, are there any significant administrative costs 
incurred when releasing contact lens prescriptions? What evidence is 
there to show that there is or is not a danger that the lenses may not 
conform to the eye as expected, thus justifying a refusal to release 
contact lens prescriptions to permit the fitter to verify the fit of 
the lens?

List of Subjects in 16 CFR Part 456

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

    Authority: 15 U.S.C. 41-58.

    By direction of the Commission.
Benjamin I. Berman,
Acting Secretary.
[FR Doc. 97-8494 Filed 4-2-97; 8:45 am]
BILLING CODE 6750-01-M