[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3140 Enrolled Bill (ENR)]
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 Consumers
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
prescription 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 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. 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--
(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 appropriate
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 prescription
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,
facsimile, 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.
(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 prescription 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
prescription.
SEC. 6. CONTENT OF ADVERTISEMENTS AND OTHER REPRESENTATIONS.
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 otherwise, 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 Commission 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.
(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 reasons
for the incidence, and the effect on consumers and competition.
(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 determines 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, 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.
(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 facsimile
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.
SEC. 12. EFFECTIVE DATE.
This Act shall take effect 60 days after the date of the enactment
of this Act.
Speaker of the House of Representatives.
Vice President of the United States and
President of the Senate.