[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:
RKinscheck@ftc.gov.
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
