PUBLIC LAW 108–164—DEC. 6, 2003

FAIRNESS TO CONTACT LENS CONSUMERS

ACT

117 STAT. 2024 PUBLIC LAW 108–164—DEC. 6, 2003

Public Law 108–164

108th Congress

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—

15 USC 7603.

15 USC 7602.

15 USC 7601.

15 USC 7601

note.

Fairness to

Contact Lens

Consumers Act.

Dec. 6, 2003

[H.R. 3140]

PUBLIC LAW 108–164—DEC. 6, 2003 117 STAT. 2025

(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.

15 USC 7604.

117 STAT. 2026 PUBLIC LAW 108–164—DEC. 6, 2003

(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.

15 USC 7609.

15 USC 7608.

Deadline.

15 USC 7607.

15 USC 7606.

15 USC 7605.

PUBLIC LAW 108–164—DEC. 6, 2003 117 STAT. 2027

(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.

15 USC 7610.

Deadline.

117 STAT. 2028 PUBLIC LAW 108–164—DEC. 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.

Æ

SEC. 12. EFFECTIVE DATE.

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

Approved December 6, 2003.

15 USC 7601

note.