[House Report 108-318]
[From the U.S. Government Publishing Office]
108th Congress Report
HOUSE OF REPRESENTATIVES
1st Session 108-318
======================================================================
FAIRNESS TO CONTACT LENS CONSUMERS ACT
_______
October 15, 2003.--Committed to the Committee of the Whole House on the
State of the Union and ordered to be printed
_______
Mr. Tauzin, from the Committee on Energy and Commerce, submitted the
following
R E P O R T
[To accompany H.R. 3140]
[Including cost estimate of the Congressional Budget Office]
The Committee on Energy and Commerce, to whom was referred
the bill (H.R. 3140) to provide for availability of contact
lens prescriptions to patients, and for other purposes, having
considered the same, report favorably thereon with an amendment
and recommend that the bill as amended do pass.
CONTENTS
Page
Purpose and Summary.............................................. 4
Background and Need for Legislation.............................. 4
Hearings......................................................... 5
Committee Consideration.......................................... 6
Committee Votes.................................................. 6
Committee Oversight Findings..................................... 6
Statement of General Performance Goals and Objectives............ 6
New Budget Authority, Entitlement Authority, and Tax Expenditures 6
Committee Cost Estimate.......................................... 6
Congressional Budget Office Estimate............................. 6
Federal Mandates Statement....................................... 8
Advisory Committee Statement..................................... 8
Constitutional Authority Statement............................... 8
Applicability to Legislative Branch.............................. 8
Section-by-Section Analysis of the Legislation................... 9
The amendment is as follows:
Strike all after the enacting clause and insert the
following:
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 C.F.R. 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.
PURPOSE AND SUMMARY
The purpose of H.R. 3140 is to provide for the availability
of contact lens prescriptions to patients, and for other
purposes.
BACKGROUND AND NEED FOR LEGISLATION
In the past ten years, there has been tremendous growth in
the contact lens business. As the business of contact lenses
has grown, so have the issues surrounding prescription release.
The practice of optometrists withholding the prescription has
limited the consumer's ability to shop for the best price and
has impacted competition.
A consumer's right to his or her eyeglass prescription was
mandated by a 1978 Federal Trade Commission (FTC) regulation.
As a result of that regulation, there is significantly more
competition, better service, and lower prices for eyeglasses.
Contact lenses were not included in that regulation because, at
that time, contact lenses were an emerging technology. Hard
lenses were predominant and were custom made for each
individual. Today, although 36 million Americans wear contact
lenses, and approximately 85 percent of all contact lens
wearers wear mass-produced soft contact lenses, consumers still
do not have the right to their contact lens prescription under
federal law. H.R. 3140 gives consumers that right.
The consumer's right to a copy of their contact lens
prescription means nothing unless consumers can fill that
prescription at the business of their choice. Consumers are now
offered a myriad of competitive options to fill contact lens
prescriptions from the optometrist's office, to third party
sellers like pharmacies, department stores, and Internet or
mail order outlets. However, despite the range of options,
consumers continue to face a difficult time getting
prescriptions filled by alternative third party sellers due to
prescription verification obstacles.
Unlike medical doctors who are prohibited from selling the
drugs they prescribe, eye doctors and optometrists
(``doctors'') are able to fill the contact lens prescriptions
they write. This sets up an inherent conflict of interest
because third party sellers are forced to compete for the sale
of lenses with the individual who is writing the prescription.
A number of states have established laws dealing with
release of contact lens prescriptions. Nearly all of these
states have mandated the right of the consumer to their
prescription, but states have taken different positions on how
and when the prescription can be verified and filled.
There are two kinds of verification systems--active and
passive. An active verification system requires a third party
seller to receive actual verification of the contact lens
prescription by the doctor before it can be filled. If a doctor
fails, intentionally or not, to call the third party seller to
verify, the prescription cannot be filled. This creates a
system that requires third party sellers to ask permission of
their competitor to make a sale. Third party sellers argue they
do not receive the verification needed to fill a prescription,
which effectively eliminates them from the market, and prevents
consumers from shopping around for lower prices and the most
convenient service.
The alternative system is passive verification, which
allows the third party seller to call the doctor to verify a
prescription and if the doctor does not call back within a
certain period of time, the prescription can be filled. H.R.
3140 adopts a passive verification system in order to best
serve the consumer. The Subcommittee on Commerce, Trade, and
Consumer Protection heard testimony from consumers and
businesses of the unusually high number of consumer complaints
in states that rely on active verification schemes. A passive
verification system ensures that consumers are not caught in
the competitive tug-of-war between doctors and third party
sellers for the sale of contact lenses.
H.R. 3140 will increase competition in the sale of contact
lenses which will bring a substantial savings to America's
contact lens wearers. Consumers spend an estimated $3.5 billion
annually on replacement contact lenses. Consumers who order
prescription refills from alternative sellers can save, on
average, 20 percent per order.
A uniform national standard for prescription release and
verification will best serve the consumer. H.R. 3140 promotes
competition, consumer choice, and lower prices by extending to
contact lens wearers the same automatic right to copies of
their own prescriptions and allows consumers to purchase
contact lenses from the provider of their choice.
HEARINGS
The Subcommittee on Commerce, Trade, and Consumer
Protection held a hearing on H.R. 2221 on September 9, 2003,
the legislative precursor to H.R. 3140. The Subcommittee
received testimony from Ms. Maria Martinez; Mr. J. Howard
Beales, III, Director, Bureau of Consumer Protection, Federal
Trade Commission; Mr. Jonathan C. Coon, Chief Executive
Officer, 1-800 Contacts; Dr. J. Pat Cummings, O.D., Immediate
Past President, American Optometric Association; Mr. Robert L.
Hubbard, Director of Litigation, Antitrust Bureau, Office of
the New York Attorney General; Ms. Ami Gadhia, Consumers Union;
and, Ms. Peggy Venable, State Director, Citizens for a Sound
Economy.
COMMITTEE CONSIDERATION
On Wednesday, September 24, 2003, the Subcommittee on
Commerce, Trade, and Consumer Protection met in open markup
session and approved H.R. 3140 for Full Committee consideration
by a voice vote, a quorum being present. On Wednesday, October
1, 2003, the Full Committee met in open markup session and
ordered H.R. 3140 favorably reported to the House, with
amendment, by a voice vote, a quorum being present.
COMMITTEE VOTES
Clause 3(b) of rule XIII of the Rules of the House of
Representatives requires the Committee to list the record votes
on the motion to report legislation and amendments thereto.
There were no record votes taken in connection with ordering
H.R. 3140 reported. A motion by Mr. Tauzin to order H.R. 3140
reported to the House was agreed to by a voice vote.
COMMITTEE OVERSIGHT FINDINGS
Pursuant to clause 3(c)(1) of rule XIII of the Rules of the
House of Representatives, the Committee has not held oversight
or legislative hearings on this legislation.
STATEMENT OF GENERAL PERFORMANCE GOALS AND OBJECTIVES
The goal of this legislation is to allow consumers access
to their contact lens prescriptions and to provide for the
verification of such prescriptions.
NEW BUDGET AUTHORITY, ENTITLEMENT AUTHORITY, AND TAX EXPENDITURES
In compliance with clause 3(c)(2) of rule XIII of the Rules
of the House of Representatives, the Committee finds that H.R.
3140, the ``Fairness to Contact Lens Consumers Act,'' would
result in no new or increased budget authority, entitlement
authority, or tax expenditures or revenues.
COMMITTEE COST ESTIMATE
The Committee adopts as its own the cost estimate prepared
by the Director of the Congressional Budget Office pursuant to
section 402 of the Congressional Budget Act of 1974.
CONGRESSIONAL BUDGET OFFICE ESTIMATE
Pursuant to clause 3(c)(3) of rule XIII of the Rules of the
House of Representatives, the following is the cost estimate
provided by the Congressional Budget Office pursuant to section
402 of the Congressional Budget Act of 1974:
U.S. Congress,
Congressional Budget Office,
Washington, DC, October 15, 2003.
Hon. W.J. ``Billy'' Tauzin,
Chairman, Committee on Energy and Commerce,
House of Representatives, Washington, DC.
Dear Mr. Chairman: The Congressional Budget Office has
prepared the enclosed cost estimate for H.R. 3140, the Fairness
to Contact Lens Consumers Act.
If you wish further details on this estimate, we will be
pleased to provide them. The CBO staff contacts are Melissa E.
Zimmerman (for federal costs), Sarah Puro (for the impact on
state and local governments), and Jean Talarico (for the impact
on the private sector).
Sincerely,
Elizabeth M. Robinson
(For Douglas Holtz-Eakin, Director).
Enclosure.
H.R. 3140--Fairness to Contact Lens Consumers Act
H.R. 3140 would establish procedures for issuers of
contact lens prescriptions to follow concerning patients'
access to prescriptions. It would direct the Federal Trade
Commission (FTC) to develop regulations to implement the bill
and to complete a study on competition in the sale of
prescription contact lenses. Based on information provided by
the FTC, CBO estimates that implementing H.R. 3140 would have
an insignificant effect on spending subject to the availability
of appropriated funds. The bill would not affect direct
spending or revenues.
H.R. 3140 contains two intergovernmental mandates as
defined by the Unfunded Mandates Reform Act (UMRA), but CBO
estimates that the resulting costs would not be significant and
would not exceed the threshold established in UMRA ($59 million
in 2003, adjusted annually for inflation).
First, the bill would preempt state law in the five states
that have stricter requirements for prescription verification,
but CBO estimates that the preemption would impose no costs on
those states. Second, the bill would require prescribers of
contact lenses--including some who may work for public
entities--to provide the patient a copy of the prescription and
to verify contact lens prescriptions to third-party
manufacturers. Since the bill would simply require eye care
professionals to return the call of a third-party manufacturer
if the prescription the manufacturer has is wrong, CBO
estimates that the bill would impose no significant costs on
those entities. In total, the costs of the mandates in the bill
would fall substantially below the threshold established in
UMRA.
H.R. 3140 would also impose private-sector mandates as
defined in UMRA on sellers and prescribers of contact lenses.
Prescribers, as defined in the bill, include ophthalmologists,
optometrists, or other persons permitted under state law to
issue prescriptions for contact lenses. CBO expects that the
incremental costs of those mandates would fall below the annual
threshold for the private sector established by UMRA ($117
million in 2003, adjusted annually for inflation).
In order to sell contact lenses, sellers would have to
obtain prescriptions from patients or prescribers directly or
by facsimile; prescriptions received by other methods would
require verification from the prescriber. The bill also would
require sellers to maintain records for all prescription
verifications that are communicated by telephone or electronic
mail.
In addition, H.R. 3140 would require the prescriber, after
a contact lens fitting, to provide a contact lens prescription
to the patient or to provide or verify the prescription to any
person designated to act on behalf of the patient. The bill
also would require prescribers, when requested by sellers of
contact lenses, to verify contact lens prescriptions.
According to the FTC, roughly two-thirds of states already
require some form of prescription release. Currently, many of
the larger sellers of contact lenses voluntarily comply with
the verification and recordkeeping requirements of the bill.
Furthermore, according to industry sources and the FTC, the
additional costs for the sellers and prescribers not now in
compliance with the requirements of the bill would be small.
CBO, therefore, expects that the incremental cost of all the
private-sector mandates in the bill would fall below UMRA's
threshold.
The CBO staff contacts for this estimate are Melissa E.
Zimmerman (for federal costs), Sarah Puro (for the impact on
state and local governments), and Jean Talarico (for the impact
on the private sector). This estimate was approved by Peter H.
Fontaine, Deputy Assistant Director for Budget Analysis.
FEDERAL MANDATES STATEMENT
The Committee adopts as its own the estimate of Federal
mandates prepared by the Director of the Congressional Budget
Office pursuant to section 423 of the Unfunded Mandates Reform
Act.
ADVISORY COMMITTEE STATEMENT
No advisory committees within the meaning of section 5(b)
of the Federal Advisory Committee Act were created by this
legislation.
CONSTITUTIONAL AUTHORITY STATEMENT
Pursuant to clause 3(d)(1) of rule XIII of the Rules of the
House of Representatives, the Committee finds that the
Constitutional authority for this legislation is provided in
Article I, section 8, clause 3, which grants Congress the power
to regulate commerce with foreign nations, among the several
States, and with the Indian tribes.
APPLICABILITY TO LEGISLATIVE BRANCH
The Committee finds that the legislation does not relate to
the terms and conditions of employment or access to public
services or accommodations within the meaning of section
102(b)(3) of the Congressional Accountability Act.
SECTION-BY-SECTION ANALYSIS OF THE LEGISLATION
Section 1. Short title
Section 1 establishes the short title as the ``Fairness to
Contact Lens Consumers Act.''
Section 2. Availability of contact lens prescriptions to patients
Section 2(a) requires prescribers to provide patients with
a copy of their contact lens prescription, whether or not
requested by the patient. Additionally, prescribers are
required to provide or verify a copy of the patients contact
lens prescription to any person designated to act on behalf of
the patient.
Section 2(b) mandates that prescribers do not, as a
condition of providing or verifying the contact lens
prescription, require purchase of contact lenses from the
prescriber, require payment in addition to, or as part of, the
fee for an eye examination, fitting and evaluation, or require
the patient to sign a waiver or release.
Section 3. Immediate payment of fees in limited circumstances
Section 3 provides that a prescriber may require payment of
fees for an eye examination, fitting or evaluation before the
release of a contact lens prescription only if the prescriber
would have required immediate payment if the examination had
not revealed the need for ophthalmic goods. Presentation of
proof of insurance coverage for that service is deemed to be
payment.
Section 4. Prescriber verification
Section 4 established a passive verification program for
the verification of contact lens prescriptions. Section 4(a)
allows a seller to verify a contact lens prescription if it is
(1) presented to the seller by the patient or prescriber
directly or by facsimile, or (2) verified by direct
communication. Section 4(b) requires the seller to maintain a
record of all direct communications referred to in (a).
Section 4(c) details the information the seller must supply
to the prescriber, in order for the prescriber to verify a
contact lens prescription: (1) Patients full name; (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; and, (6) name of contact person at
seller's company, including facsimile and telephone number.
Section 4(d) requires that a contact lens prescription be
verified only in one of three ways. First, verification occurs
when the prescriber confirms the prescription is accurate by
direct communication with the seller. Second, verification
occurs when a prescriber informs the seller that the
prescription is inaccurate and then provides the accurate
prescription. Finally, verification occurs if the prescriber
fails to communicate with the seller within 8 business hours,
or a similar time as defined by the FTC as part of its
rulemaking, after receiving from the information described in
subsection (c). The Committee believes that any state law with
an active or positive contact lens prescription verification
system would stand as an obstacle to the accomplishment of the
full purposes and objectives of this Act. Practically, it would
be impossible to comply with the terms of this Act and an
active verification scheme. Therefore, it is the intent of the
Committee that the passive verification system in section 4(d)
preempt any conflicting state laws that use active or positive
contact lens prescription verification systems.
Section 4(e) does not allow the seller to fill a
prescription if a prescriber informs a seller before the
deadline in section 4(d)(3) that the contact lens prescription
in inaccurate, expired, or otherwise invalid. The prescriber
must specify the basis for invalidity or inaccuracy. Finally,
if the prescription communicated by the seller to the
prescriber is inaccurate, the prescriber must correct it. Under
section 4(f), a seller may not alter a contact lens
prescription. However, 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. This paragraph is designed to prevent eye doctors from
prescribing private label contact lenses that can only be
filled by the eye doctor.
``Direct communication'' is defined in section 4(g) as
including communication by telephone, facsimile, or electronic
mail. This list is not exclusive, and the Committee recognizes
that possession by the seller of a copy of a valid prescription
released pursuant to the consumer pursuant to section 2 shall
also constitute ``direct communication.'' It is the intent of
the Committee that ``direct communication'' means a message has
been both sent and received. Transmitting the request under
5(c) does not, in and of itself, constitute a direct
communication. For instance, when a facsimile that is
considered a ``direct communication'' is sent, the direct
communication does not occur until a confirmation that the
facsimile transmission was successful is sent. Similarly, if,
for example, a prescriber is closed on Wednesday, has a phone
recording stating that the office will be open at 9:00 a.m. on
Thursday, and verification request information is left on the
machine Tuesday evening after normal business hours, the direct
communication would not occur, and the time period for
verification of the prescription would not commence, until
Thursday when the prescriber receives the request and his or
her business hours resume. The Committee directs the FTC to set
rules defining the time frame for verification and how it is
calculated, and expects the FTC's rules to be crafted
consistent with this intent.
Section 5. Expiration of contact lens prescriptions
Section 5(a) details when a contact lens prescription
expires. A contact lens prescription will expire (1) on the
date specified by the law of the state in which the
prescription is written, if that date is at least one year
after the issue of date of the prescription; or (2) not less
than one year after the issue date of the prescription if there
is no state law or if the prescription is for less than one
year. Section 5(a)(3) allows an eye doctor to write a contact
lens prescription for less than one year if based on the
medical judgment of the prescriber with respect to the ocular
health of the patient. Section 5(b) requires that if a
prescriber determines that the ocular health of the patient
necessitates a prescription for less than one year, the reasons
for this judgment must be documented in the patient's medical
record. Section 5(c) defines ``issue date'' as the date on
which the patient receives a copy of the prescription.
Section 6. Content of advertisements and other representations
Section 6 prohibits any manufacturer, processer, seller or
distributor of contact lenses to represent by advertisement,
sales presentation or otherwise, that contact lenses may be
obtained without a prescription.
Section 7. Prohibition of certain waivers
Section 7 prohibits a prescriber from placing on a contact
lens prescription, or requiring a patient to sign or deliver to
the patient, a form or notice waiving or disclaiming the
liability of the prescriber for the accuracy of the eye
examination. This does not impose liability on a prescriber for
ophthalmic goods and services dispensed by another seller
pursuant to the prescribers correctly verified prescription.
Section 8. Rulemaking by Federal Trade Commission
Section 8 requires the FTC to initiate a rulemaking
pursuant to section 18 of the Federal Trade Commission Act (15
U.S.C. 57a) to effectuate this Act. These rules are exempt from
the Magnuson-Moss Warranty-Federal Trade Commission Improvement
Act (15 U.S.C. 2301 et seq.) requirements. These rules shall
become effective not less than 180 days after the effective
date of the Act.
Section 9. Violations
Section 9(a) directs the FTC to treat any violation of the
Act or the rules enacted pursuant to the Act like 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. Section 9(b) requires the FTC to enforce the 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.
Section 10. Study and report
Section 10(a) requires the FTC to undertake a study to
examine the strength of competition in the sale of prescription
contact lenses. The study shall include a review of the
following issues: (1) The incidence of exclusive relationships
between prescribers or sellers and contact lens manufacturers
and the impact of these relationships on competition; (2) the
difference between online and offline sellers of contact
lenses; (3) the incidence, if any, of contact lens
prescriptions that specify brand name or custom labeled contact
lenses, the reasons for the incidence, and the effects on
consumers and competition; (4) the impact of the FTC eyeglasses
rule on competition, the enforcement of the rule, and how
enforcement has impacted competition; and, (5) any other issue
that has an impact of competition in the sale of prescription
contact lenses. Section 10(b) requires the report be completed
and submitted to Congress not later than 12 months after the
effective date of the Act.
Section 11. Definitions
Section 11 defines ``contact lens fitting,''
``prescriber,'' and ``contact lens prescription.'' These
definitions are intended to be consistent with state and
federal law, including any Food and Drug Administration
regulations.
Section 12. Effective date
Section 12 provides that the Act take effect 60 days after
the date of enactment.