11-19-03
Passed
House 406-12
108th CONGRESS
1st Session
H. R. 3140
To provide for availability of
contact lens prescriptions to patients, and for other purposes.
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.
(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:
(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.
Passed the House of Representatives November 19, 2003.
Attest:
Clerk.
END