H. R. 3140
One Hundred Eighth Congress
of the
United States of America
AT THE FIRST SESSION
Begun and held at the City of Washington on Tuesday,
the seventh day of January, two thousand and three
An Act
To provide for availability of contact lens prescriptions to patients, and for other
purposes.
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Fairness to Contact Lens Con-
sumers Act’’.
SEC. 2. 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 prescrip-
tion by electronic or other means.
(b) LIMITATIONS.—A prescriber may not—
(1) require purchase of contact lenses from the prescriber
or from another person as a condition of providing a copy
of a prescription under subsection (a)(1) or (a)(2) or verification
of a prescription under subsection (a)(2);
(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 subsection (a)(1)
or (a)(2) or verification of a prescription under subsection (a)(2);
or
(3) require the patient to sign a waiver or release as a
condition of verifying or releasing a prescription.
SEC. 3. IMMEDIATE PAYMENT OF FEES IN LIMITED CIRCUMSTANCES.
A prescriber may require payment of fees for an eye examina-
tion, 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, presen-
tation of proof of insurance coverage for that service shall be deemed
to be a payment.
SEC. 4. PRESCRIBER VERIFICATION.
(a) PRESCRIPTION REQUIREMENT.—A seller may sell contact
lenses only in accordance with a contact lens prescription for the
patient that is—
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(1) presented to the seller by the patient or prescriber
directly or by facsimile; or
(2) verified by direct communication.
(b) RECORD REQUIREMENT.—A seller shall maintain a record
of all direct communications referred to in subsection (a).
(c) INFORMATION.—When seeking verification of a contact lens
prescription, a seller shall provide the prescriber with the following
information:
(1) Patient’s full name and address.
(2) Contact lens power, manufacturer, base curve or appro-
priate designation, and diameter when appropriate.
(3) Quantity of lenses ordered.
(4) Date of patient request.
(5) Date and time of verification request.
(6) Name of contact person at seller’s company, including
facsimile and telephone number.
(d) VERIFICATION EVENTS.—A prescription is verified under this
Act 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 that the prescription
is inaccurate and provides the accurate prescription.
(3) The prescriber fails to communicate with the seller
within 8 business hours, or a similar time as defined by the
Federal Trade Commission, after receiving from the seller the
information described in subsection (c).
(e) INVALID PRESCRIPTION.—If a prescriber informs a seller
before the deadline under subsection (d)(3) 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 prescrip-
tion communicated by the seller to the prescriber is inaccurate,
the prescriber shall correct it.
(f) NO ALTERATION.—A seller may not alter a contact lens
prescription. Notwithstanding the preceding sentence, if the same
contact lens is manufactured by the same company and sold under
multiple labels to individual providers, the seller may fill the
prescription with a contact lens manufactured by that company
under another label.
(g) DIRECT COMMUNICATION.—As used in this section, the term
‘‘direct communication’’ includes communication by telephone, fac-
simile, or electronic mail.
SEC. 5. 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 a date that
is less than one year after the issue date of the prescription;
or
(3) notwithstanding paragraphs (1) and (2), 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.
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(b) SPECIAL RULES FOR PRESCRIPTIONS OF LESS THAN 1 YEAR.—
If a prescription expires in less than 1 year, the reasons for the
judgment referred to in subsection (a)(3) shall be documented in
the patient’s medical record. In no circumstance shall the prescrip-
tion expiration date be less than the period of time recommended
by the prescriber for a reexamination of the patient that is medically
necessary.
(c) DEFINITION.—As used in this section, the term ‘‘issue date’’
means the date on which the patient receives a copy of the prescrip-
tion.
SEC. 6. CONTENT OF ADVERTISEMENTS AND OTHER REPRESENTA-
TIONS.
Any person that engages in the manufacture, processing,
assembly, sale, offering for sale, or distribution of contact lenses
may not represent, by advertisement, sales presentation, or other-
wise, that contact lenses may be obtained without a prescription.
SEC. 7. PROHIBITION OF CERTAIN WAIVERS.
A prescriber may not place on the 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. 8. RULEMAKING BY FEDERAL TRADE COMMISSION.
The Federal Trade Commission shall prescribe rules pursuant
to section 18 of the Federal Trade Commission Act (15 U.S.C.
57a) to carry out this Act. Rules so prescribed shall be exempt
from the requirements of the Magnuson-Moss Warranty—Federal
Trade Commission Improvement Act (15 U.S.C. 2301 et seq.). Any
such regulations shall be issued in accordance with section 553
of title 5, United States Code. The first rules under this section
shall take effect not later than 180 days after the effective date
of this Act.
SEC. 9. VIOLATIONS.
(a) IN GENERAL.—Any violation of this Act or the rules required
under section 8 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.
(b) ACTIONS BY THE COMMISSION.—The Federal Trade Commis-
sion shall enforce this Act in the same manner, by the same means,
and with the same jurisdiction, powers, and duties as though all
applicable terms and provisions of the Federal Trade Commission
Act (15 U.S.C. 41 et seq.) were incorporated into and made a
part of this Act.
SEC. 10. STUDY AND REPORT.
(a) STUDY.—The Federal Trade Commission shall undertake
a study to examine the strength of competition in the sale of
prescription contact lenses. The study shall include an examination
of the following issues:
(1) Incidence of exclusive relationships between prescribers
or sellers and contact lens manufacturers and the impact of
such relationships on competition.
H. R. 3140—4
(2) Difference between online and offline sellers of contact
lenses, including price, access, and availability.
(3) Incidence, if any, of contact lens prescriptions that
specify brand name or custom labeled contact lenses, the rea-
sons for the incidence, and the effect on consumers and competi-
tion.
(4) The impact of the Federal Trade Commission eyeglasses
rule (16 CFR 456 et seq.) on competition, the nature of the
enforcement of the rule, and how such enforcement has
impacted competition.
(5) Any other issue that has an impact on competition
in the sale of prescription contact lenses.
(b) REPORT.—Not later than 12 months after the effective date
of this Act, the Chairman of the Federal Trade Commission shall
submit to the Congress a report of the study required by subsection
(a).
SEC. 11. DEFINITIONS.
As used in this Act:
(1) CONTACT LENS FITTING.—The term ‘‘contact lens fitting’’
means the process that begins after the initial eye examination
and ends when a successful fit has been achieved or, in the
case of a renewal prescription, ends when the prescriber deter-
mines that no change in prescription is required, and such
term may include—
(A) an examination to determine lens specifications;
(B) except in the case of a renewal of a prescription,
an initial evaluation of the fit of the lens on the eye;
and
(C) medically necessary follow up examinations.
(2) PRESCRIBER.—The term ‘‘prescriber’’ means, with
respect to contact lens prescriptions, an ophthalmologist, optom-
etrist, 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.
(3) CONTACT LENS PRESCRIPTION.—The term ‘‘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, including
the following:
(A) Name of the patient.
(B) Date of examination.
(C) Issue date and expiration date of prescription.
(D) Name, postal address, telephone number, and fac-
simile telephone number of prescriber.
(E) Power, material or manufacturer or both.
(F) Base curve or appropriate designation.
(G) Diameter, when appropriate.
(H) In the case of a private label contact lens, name
of manufacturer, trade name of private label brand, and,
if applicable, trade name of equivalent brand name.
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SEC. 12. EFFECTIVE DATE.
This Act shall take effect 60 days after the date of the enact-
ment of this Act.
Speaker of the House of Representatives.
Vice President of the United States and
President of the Senate.