108TH CONGRESS

1ST SESSION H. R. 3140

AN ACT

To provide for availability of contact lens

prescriptions to patients, and for other purposes.

108TH CONGRESS

1ST SESSION H. R. 3140

AN ACT

To provide for availability of contact lens prescriptions to

patients, and for other purposes.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,
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1 SECTION 1. SHORT TITLE.

2 This Act may be cited as the ‘‘Fairness to Contact

3 Lens Consumers Act’’.

4 SEC. 2. AVAILABILITY OF CONTACT LENS PRESCRIPTIONS

5 TO PATIENTS.

6 (a) IN GENERAL.—When a prescriber completes a

7 contact lens fitting, the prescriber—

8 (1) whether or not requested by the patient,

9 shall provide to the patient a copy of the contact

10 lens prescription; and

11 (2) shall, as directed by any person designated

12 to act on behalf of the patient, provide or verify the

13 contact lens prescription by electronic or other

14 means.

15 (b) LIMITATIONS.—A prescriber may not—

16 (1) require purchase of contact lenses from the

17 prescriber or from another person as a condition of

18 providing a copy of a prescription under subsection

19 (a)(1) or (a)(2) or verification of a prescription

20 under subsection (a)(2);

21 (2) require payment in addition to, or as part

22 of, the fee for an eye examination, fitting, and eval23 uation as a condition of providing a copy of a pre24 scription under subsection (a)(1) or (a)(2) or

25 verification of a prescription under subsection (a)(2);

26 or
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1 (3) require the patient to sign a waiver or re2 lease as a condition of verifying or releasing a pre3 scription.

4 SEC. 3. IMMEDIATE PAYMENT OF FEES IN LIMITED CIR5 CUMSTANCES.

6 A prescriber may require payment of fees for an eye

7 examination, fitting, and evaluation before the release of

8 a contact lens prescription, but only if the prescriber re9 quires immediate payment in the case of an examination

10 that reveals no requirement for ophthalmic goods. For

11 purposes of the preceding sentence, presentation of proof

12 of insurance coverage for that service shall be deemed to

13 be a payment.

14 SEC. 4. PRESCRIBER VERIFICATION.

15 (a) PRESCRIPTION REQUIREMENT.—A seller may sell

16 contact lenses only in accordance with a contact lens pre17 scription for the patient that is—

18 (1) presented to the seller by the patient or pre19 scriber directly or by facsimile; or

20 (2) verified by direct communication.

21 (b) RECORD REQUIREMENT.—A seller shall maintain

22 a record of all direct communications referred to in sub23 section (a).
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1 (c) INFORMATION.—When seeking verification of a

2 contact lens prescription, a seller shall provide the pre3 scriber with the following information:

4 (1) Patient’s full name and address.

5 (2) Contact lens power, manufacturer, base

6 curve or appropriate designation, and diameter when

7 appropriate.

8 (3) Quantity of lenses ordered.

9 (4) Date of patient request.

10 (5) Date and time of verification request.

11 (6) Name of contact person at seller’s company,

12 including facsimile and telephone number.

13 (d) VERIFICATION EVENTS.—A prescription is

14 verified under this Act only if one of the following occurs:

15 (1) The prescriber confirms the prescription is

16 accurate by direct communication with the seller.

17 (2) The prescriber informs the seller that the

18 prescription is inaccurate and provides the accurate

19 prescription.

20 (3) The prescriber fails to communicate with

21 the seller within 8 business hours, or a similar time

22 as defined by the Federal Trade Commission, after

23 receiving from the seller the information described in

24 subsection (c).
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1 (e) INVALID PRESCRIPTION.—If a prescriber informs

2 a seller before the deadline under subsection (d)(3) that

3 the contact lens prescription is inaccurate, expired, or oth4 erwise invalid, the seller shall not fill the prescription. The

5 prescriber shall specify the basis for the inaccuracy or in6 validity of the prescription. If the prescription commu7 nicated by the seller to the prescriber is inaccurate, the

8 prescriber shall correct it.

9 (f) NO ALTERATION.—A seller may not alter a con10 tact lens prescription. Notwithstanding the preceding sen11 tence, if the same contact lens is manufactured by the

12 same company and sold under multiple labels to individual

13 providers, the seller may fill the prescription with a con14 tact lens manufactured by that company under another

15 label.

16 (g) DIRECT COMMUNICATION.—As used in this sec17 tion, the term ‘‘direct communication’’ includes commu18 nication by telephone, facsimile, or electronic mail.

19 SEC. 5. EXPIRATION OF CONTACT LENS PRESCRIPTIONS.

20 (a) IN GENERAL.—A contact lens prescription shall

21 expire—

22 (1) on the date specified by the law of the State

23 in which the prescription was written, if that date is

24 one year or more after the issue date of the prescrip25 tion;
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1 (2) not less than one year after the issue date

2 of the prescription if such State law specifies no

3 date or a date that is less than one year after the

4 issue date of the prescription; or

5 (3) notwithstanding paragraphs (1) and (2), on

6 the date specified by the prescriber, if that date is

7 based on the medical judgment of the prescriber

8 with respect to the ocular health of the patient.

9 (b) SPECIAL RULES FOR PRESCRIPTIONS OF LESS

10 THAN 1 YEAR.—If a prescription expires in less than 1

11 year, the reasons for the judgment referred to in sub12 section (a)(3) shall be documented in the patient’s medical

13 record. In no circumstance shall the prescription expira14 tion date be less than the period of time recommended

15 by the prescriber for a reexamination of the patient that

16 is medically necessary.

17 (c) DEFINITION.—As used in this section, the term

18 ‘‘issue date’’ means the date on which the patient receives

19 a copy of the prescription.

20 SEC. 6. CONTENT OF ADVERTISEMENTS AND OTHER REP21 RESENTATIONS.

22 Any person that engages in the manufacture, proc23 essing, assembly, sale, offering for sale, or distribution of

24 contact lenses may not represent, by advertisement, sales
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1 presentation, or otherwise, that contact lenses may be ob2 tained without a prescription.

3 SEC. 7. PROHIBITION OF CERTAIN WAIVERS.

4 A prescriber may not place on the prescription, or

5 require the patient to sign, or deliver to the patient a form

6 or notice waiving or disclaiming the liability or responsi7 bility of the prescriber for the accuracy of the eye exam8 ination. The preceding sentence does not impose liability

9 on a prescriber for the ophthalmic goods and services dis10 pensed by another seller pursuant to the prescriber’s cor11 rectly verified prescription.

12 SEC. 8. RULEMAKING BY FEDERAL TRADE COMMISSION.

13 The Federal Trade Commission shall prescribe rules

14 pursuant to section 18 of the Federal Trade Commission

15 Act (15 U.S.C. 57a) to carry out this Act. Rules so pre16 scribed shall be exempt from the requirements of the Mag17 nuson-Moss Warranty—Federal Trade Commission Im18 provement Act (15 U.S.C. 2301 et seq.). Any such regula19 tions shall be issued in accordance with section 553 of title

20 5, United States Code. The first rules under this section

21 shall take effect not later than 180 days after the effective

22 date of this Act.

23 SEC. 9. VIOLATIONS.

24 (a) IN GENERAL.—Any violation of this Act or the

25 rules required under section 8 shall be treated as a viola-
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1 tion of a rule under section 18 of the Federal Trade Com2 mission Act (15 U.S.C. 57a) regarding unfair or deceptive

3 acts or practices.

4 (b) ACTIONS BY THE COMMISSION.—The Federal

5 Trade Commission shall enforce this Act in the same man6 ner, by the same means, and with the same jurisdiction,

7 powers, and duties as though all applicable terms and pro8 visions of the Federal Trade Commission Act (15 U.S.C.

9 41 et seq.) were incorporated into and made a part of this

10 Act.

11 SEC. 10. STUDY AND REPORT.

12 (a) STUDY.—The Federal Trade Commission shall

13 undertake a study to examine the strength of competition

14 in the sale of prescription contact lenses. The study shall

15 include an examination of the following issues:

16 (1) Incidence of exclusive relationships between

17 prescribers or sellers and contact lens manufacturers

18 and the impact of such relationships on competition.

19 (2) Difference between online and offline sellers

20 of contact lenses, including price, access, and avail21 ability.

22 (3) Incidence, if any, of contact lens prescrip23 tions that specify brand name or custom labeled con24 tact lenses, the reasons for the incidence, and the ef25 fect on consumers and competition.
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1 (4) The impact of the Federal Trade Commis2 sion eyeglasses rule (16 CFR 456 et seq.) on com3 petition, the nature of the enforcement of the rule,

4 and how such enforcement has impacted competi5 tion.

6 (5) Any other issue that has an impact on com7 petition in the sale of prescription contact lenses.

8 (b) REPORT.—Not later than 12 months after the ef9 fective date of this Act, the Chairman of the Federal

10 Trade Commission shall submit to the Congress a report

11 of the study required by subsection (a).

12 SEC. 11. DEFINITIONS.

13 As used in this Act:

14 (1) CONTACT LENS FITTING.—The term ‘‘con15 tact lens fitting’’ means the process that begins after

16 the initial eye examination and ends when a success17 ful fit has been achieved or, in the case of a renewal

18 prescription, ends when the prescriber determines

19 that no change in prescription is required, and such

20 term may include—

21 (A) an examination to determine lens spec22 ifications;

23 (B) except in the case of a renewal of a

24 prescription, an initial evaluation of the fit of

25 the lens on the eye; and
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1 (C) medically necessary follow up examina2 tions.

3 (2) PRESCRIBER.—The term ‘‘prescriber’’

4 means, with respect to contact lens prescriptions, an

5 ophthalmologist, optometrist, or other person per6 mitted under State law to issue prescriptions for

7 contact lenses in compliance with any applicable re8 quirements established by the Food and Drug Ad9 ministration.

10 (3) CONTACT LENS PRESCRIPTION.—The term

11 ‘‘contact lens prescription’’ means a prescription,

12 issued in accordance with State and Federal law,

13 that contains sufficient information for the complete

14 and accurate filling of a prescription, including the

15 following:

16 (A) Name of the patient.

17 (B) Date of examination.

18 (C) Issue date and expiration date of pre19 scription.

20 (D) Name, postal address, telephone num21 ber, and facsimile telephone number of pre22 scriber.

23 (E) Power, material or manufacturer or

24 both.

25 (F) Base curve or appropriate designation.
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1 (G) Diameter, when appropriate.

2 (H) In the case of a private label contact

3 lens, name of manufacturer, trade name of pri4 vate label brand, and, if applicable, trade name

5 of equivalent brand name.

6 SEC. 12. EFFECTIVE DATE.

7 This Act shall take effect 60 days after the date of

8 the enactment of this Act.

Passed the House of Representatives November 19,

2003.

Attest:

Clerk.