[108th Congress Public Law 164]
[From the U.S. Government Printing Office]


[DOCID: f:publ164.108]

[[Page 2024]]

                 FAIRNESS TO CONTACT LENS CONSUMERS ACT

[[Page 117 STAT. 2025]]

Public Law 108-164
108th Congress

                                 An Act


 
 To provide for availability of contact lens prescriptions to patients, 
     and for other purposes. <<NOTE: Dec. 6, 2003 -  [H.R. 3140]>> 

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled, <<NOTE: Fairness to 
Contact Lens Consumers Act.>> 

SECTION 1. <<NOTE: 15 USC 7601 note.>> SHORT TITLE.

    This Act may be cited as the ``Fairness to Contact Lens Consumers 
Act''.

SEC. 2. <<NOTE: 15 USC 7601.>> 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. <<NOTE: 15 USC 7602.>> 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. <<NOTE: 15 USC 7603.>> PRESCRIBER VERIFICATION.

    (a) Prescription Requirement.--A seller may sell contact lenses only 
in accordance with a contact lens prescription for the patient that is--

[[Page 117 STAT. 2026]]

            (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. <<NOTE: 15 USC 7604.>> 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.

[[Page 117 STAT. 2027]]

    (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. <<NOTE: 15 USC 7605.>> 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. <<NOTE: 15 USC 7606.>> 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. <<NOTE: 15 USC 7607.>> 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. <<NOTE: Deadline.>>  The first rules under this section shall take 
effect not later than 180 days after the effective date of this Act.

SEC. 9. <<NOTE: 15 USC 7608.>> 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. <<NOTE: 15 USC 7609.>> 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.

[[Page 117 STAT. 2028]]

            (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) <<NOTE: Deadline.>> 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. <<NOTE: 15 USC 7610.>> 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.

[[Page 117 STAT. 2029]]

SEC. 12. <<NOTE: 15 USC 7601 note.>> EFFECTIVE DATE.

    This Act shall take effect 60 days after the date of the enactment 
of this Act.

    Approved December 6, 2003.

LEGISLATIVE HISTORY--H.R. 3140:
---------------------------------------------------------------------------

HOUSE REPORTS: No. 108-318 (Comm. on Energy and Commerce).
CONGRESSIONAL RECORD, Vol. 149 (2003):
            Nov. 19, considered and passed House.
            Nov. 20, considered and passed Senate.

                                  <all>
