[House Hearing, 108 Congress]
[From the U.S. Government Publishing Office]
FAIRNESS TO CONTACT LENS CONSUMERS ACT
=======================================================================
HEARING
before the
SUBCOMMITTEE ON
COMMERCE, TRADE, AND CONSUMER PROTECTION
of the
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED EIGHTH CONGRESS
FIRST SESSION
on
H.R. 2221
__________
SEPTEMBER 12, 2003
__________
Serial No. 108-41
__________
Printed for the use of the Committee on Energy and Commerce
Available via the World Wide Web: http://www.access.gpo.gov/congress/
house
__________
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____________________________________________________________________________
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COMMITTEE ON ENERGY AND COMMERCE
W.J. ``BILLY'' TAUZIN, Louisiana, Chairman
MICHAEL BILIRAKIS, Florida JOHN D. DINGELL, Michigan
JOE BARTON, Texas Ranking Member
FRED UPTON, Michigan HENRY A. WAXMAN, California
CLIFF STEARNS, Florida EDWARD J. MARKEY, Massachusetts
PAUL E. GILLMOR, Ohio RALPH M. HALL, Texas
JAMES C. GREENWOOD, Pennsylvania RICK BOUCHER, Virginia
CHRISTOPHER COX, California EDOLPHUS TOWNS, New York
NATHAN DEAL, Georgia FRANK PALLONE, Jr., New Jersey
RICHARD BURR, North Carolina SHERROD BROWN, Ohio
Vice Chairman BART GORDON, Tennessee
ED WHITFIELD, Kentucky PETER DEUTSCH, Florida
CHARLIE NORWOOD, Georgia BOBBY L. RUSH, Illinois
BARBARA CUBIN, Wyoming ANNA G. ESHOO, California
JOHN SHIMKUS, Illinois BART STUPAK, Michigan
HEATHER WILSON, New Mexico ELIOT L. ENGEL, New York
JOHN B. SHADEGG, Arizona ALBERT R. WYNN, Maryland
CHARLES W. ``CHIP'' PICKERING, GENE GREEN, Texas
Mississippi KAREN McCARTHY, Missouri
VITO FOSSELLA, New York TED STRICKLAND, Ohio
ROY BLUNT, Missouri DIANA DeGETTE, Colorado
STEVE BUYER, Indiana LOIS CAPPS, California
GEORGE RADANOVICH, California MICHAEL F. DOYLE, Pennsylvania
CHARLES F. BASS, New Hampshire CHRISTOPHER JOHN, Louisiana
JOSEPH R. PITTS, Pennsylvania TOM ALLEN, Maine
MARY BONO, California JIM DAVIS, Florida
GREG WALDEN, Oregon JAN SCHAKOWSKY, Illinois
LEE TERRY, Nebraska HILDA L. SOLIS, California
ERNIE FLETCHER, Kentucky
MIKE FERGUSON, New Jersey
MIKE ROGERS, Michigan
DARRELL E. ISSA, California
C.L. ``BUTCH'' OTTER, Idaho
Dan R. Brouillette, Staff Director
James D. Barnette, General Counsel
Reid P.F. Stuntz, Minority Staff Director and Chief Counsel
______
Subcommittee on Commerce, Trade, and Consumer Protection
CLIFF STEARNS, Florida, Chairman
FRED UPTON, Michigan JAN SCHAKOWSKY, Illinois
BARBARA CUBIN, Wyoming Ranking Member
JOHN SHIMKUS, Illinois HILDA L. SOLIS, California
JOHN B. SHADEGG, Arizona EDWARD J. MARKEY, Massachusetts
Vice Chairman EDOLPHUS TOWNS, New York
GEORGE RADANOVICH, California SHERROD BROWN, Ohio
CHARLES F. BASS, New Hampshire JIM DAVIS, Florida
JOSEPH R. PITTS, Pennsylvania PETER DEUTSCH, Florida
MARY BONO, California BART STUPAK, Michigan
LEE TERRY, Nebraska GENE GREEN, Texas
ERNIE FLETCHER, Kentucky KAREN McCARTHY, Missouri
MIKE FERGUSON, New Jersey TED STRICKLAND, Ohio
DARRELL E. ISSA, California DIANA DeGETTE, Colorado
C.L. ``BUTCH'' OTTER, Idaho JOHN D. DINGELL, Michigan,
W.J. ``BILLY'' TAUZIN, Louisiana (Ex Officio)
(Ex Officio)
(ii)
C O N T E N T S
__________
Page
Testimony of:
Beales, J. Howard, III, Director, Bureau of Consumer
Protection, Federal Trade Commission....................... 6
Coon, Jonathan C., Chief Executive Officer, 1-800 Contacts... 12
Cummings, J. Pat, Immediate Past President, American
Optometric Association..................................... 185
Gadhia, Ami V., Consumers Union.............................. 194
Hubbard, Robert L., Director of Litigation, Antitrust Bureau,
Office of the New York Attorney General.................... 189
Martinez, Maria.............................................. 5
Venable, Peggy, State Director, Citizens for a Sound Economy. 207
(iii)
FAIRNESS TO CONTACT LENS CONSUMERS ACT
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TUESDAY, SEPTEMBER 9, 2003
House of Representatives,
Committee on Energy and Commerce,
Subcommittee on Commerce, Trade,
and Consumer Protection,
Washington, DC.
The subcommittee met, pursuant to notice, at 1 p.m., in
room 2123 of the Rayburn House Office Building, Hon. Cliff
Stearns (chairman) presiding.
Members present: Representatives Stearns, Shimkus, Terry,
Schakowsky, and Green.
Also present: Representative Burr.
Staff present: Kelly Zerzan, majority counsel; Ramsen
Betfarhad, policy coordinator; Jill Latham, legislative clerk;
Jon Tripp, deputy communications director; and Jonathan
Cordone, minority counsel.
Mr. Stearns. The subcommittee will come to order. Without
objection, the subcommittee will proceed pursuant to Committee
Rule 4(e). So ordered. The Chair recognizes himself for an
opening statement.
My colleagues, welcome to this afternoon's hearing on H.R.
2221, the Fairness to Contact Lens Consumers Act introduced by
the committee's vice chairman, Congressman Richard Burr.
Although Congressman Burr is not a member of the Commerce,
Trade, and Consumer Protection Subcommittee, I believe he will
be joining us.
Today, 36 million Americans wear contact lenses. With
advances in technology, consumers are offered a myriad of
options for eye care, from disposable lenses used for just 1
day, to lenses that can be used for a month, to lenses that can
be used for a year.
As the contact lens business has grown, so have the
available outlets for buying contact lenses. Today, a consumer
can go to Wal-Mart or Costco, the Internet, or to mail order
companies to purchase these lenses. With such intense
competition, contact lenses have become more affordable, making
them more accessible and available to consumers.
To buy and wear contact lenses, however, a consumer must
have a prescription from a licensed doctor or an optometrist.
It is at this point where the market has seen competitive
obstacles erected that can make purchasing contact lenses from
third party sellers more difficult.
In my home State of Florida, a patient is entitled to a
copy of his or her prescription if they request it. But around
the country, as we will learn today, contact lens prescription
release does not always happen as it should.
We are fortunate to have with us Maria Martinez, a
consumer, who will share with us her challenging experiences
trying to get a copy of her contact lens prescription. As her
story will illustrate, some eye doctors will refuse to release
prescriptions or will condition release on the purchase of
contact lenses from the doctor's practice. Clearly, these are
anti-competitive practices that limit options and increase
prices. H.R. 2221 is designed to eliminate this market-altering
practice.
In order for consumers to be best served, there should be
responsibilities and commitments made by both sides of the
prescription release transaction. Doctors should freely give
patients their contact lens prescription and should promptly
verify such prescriptions, and third party sellers should
accurately provide patient information and allow a reasonable
time for verification.
I believe this bill is a step toward making the contact
lens landscape truly competitive. Consumers deserve that. I
look forward to hearing from our witnesses today.
I yield back.
With that, the gentleman from Texas is recognized.
Mr. Green. Thank you, Mr. Chairman. I will put my full
statement in the record.
I agree with what you said. We need to make sure that that
the law keeps up with the industry and the success we have had.
I have some concern, though, that I don't want to treat contact
lenses any different than I do any other prescription.
Typically if I have a prescription from my physician for a
certain type of medication, it may last 90 days or a year. And
just because I may want to have it filled 1\1/2\ years later
doesn't mean that that is possible.
So I think we should have some type of definite way that
there is verification on prescriptions because, again, I think
the consumer needs to be able to shop around and have that
opportunity, but I also know that we want to make sure that
they are getting the contact lens or the prescription in other
cases that will benefit them.
And with that, again, I will put my full statement into the
record. Thank you.
Mr. Stearns. By unanimous consent, so ordered.
[The prepared statement of Hon. Gene Green follows:]
Prepared Statement of Hon. Gene Green, a Representative in Congress
from the State of Texas
Thank you, Chairman Stearns and Ranking Member Schakowsky, for
holding this hearing on consumer access and competition in the contact
lens industry.
I also thank our panel of witnesses for being here today and offer
a special welcome to my fellow Texans, Ms. Venable and Ms. Martinez.
We appreciate your coming to share Texas's experience with this
issue.
Over the past twenty years, the market for contact lenses has grown
and changed dramatically.
The contact lenses worn today by 36 million Americans are far
different from the hard contacts of the 1980s that had to be specially
crafted and ordered for each individual patient.
The mass manufacture of soft lenses has enabled more consumers to
wear contacts and more companies to sell them.
Without question, this increased access and competition is good for
both consumers and business.
Our colleague Mr. Burr has introduced a bill that is a good start
toward ensuring that all contact lens wearers are given their
prescriptions and allowed to shop around and find the best price for
their contacts.
Our good friends at the FTC have ensured that, by law, individuals
must have access to their eyeglass prescriptions.
In my view, contact lens wearers should be treated no differently--
the release of their prescriptions should not contingent upon a follow-
up exam or any future business by the consumer.
Therefore, I agree wholeheartedly with the intent of the Fairness
to Contact Lens Consumers Act, and I applaud Mr. Burr for taking on
this issue. I do think, however, that any legislation guaranteeing
consumers access to their prescriptions should provide doctors with a
specific means of verifying them.
If we mandate by federal law that consumers must be given their
prescription but don't give sellers a uniform verification standard to
follow, I worry that we would create a level of confusion that could
negate the consumer benefits in this bill.
I also think that the verification standard for contact lenses
should follow that of any other prescription.
The obvious difference between prescriptions for contact lens
prescriptions and drugs, however, is that the pharmacy filling the
prescription drug isn't in relying on its competitor for verification,
since medical doctors cannot fill the prescriptions they write. So, we
need to devise a standard that creates a level playing field for all
contact lens sellers and allows consumers full and open access to them.
In doing so, however, we also need to make sure that we encourage
consumers to get regular eye exams. Increased access to contact lenses
should not come at the expense of proper eye care.
I am confident that the committee can work in a bi-partisan fashion
to resolve these issues as well as some underlying enforcement
concerns, and pass this consumer-friendly bill.
Again, I thank our witnesses for appearing today and look forward
to your testimony and the light it will shed on this important subject.
With that, Mr. Chairman, I yield back the balance of my time.
[Additional statements submitted for the record follow:]
Prepared Statement of Hon. John Shimkus, a Representative in Congress
from the State of Illinois
Good Afternoon. Mr. Chairman, thank you for holding this hearing to
address the importance of providing consumers more free-market access
to goods--and as we will discuss in this particular hearing, contact
lenses.
I wear contact lenses and as a consumer I know that it has not been
easy for consumers of contact lenses to have free market access to
these products. I have always supported measures that decreased
barriers for consumers and follow the philosophy that as a legislator
less government intrusion into the marketplace is better for the
American public.
However, I applaud the work of our optometrists and
ophthalmologists who provide excellent care to thousands of patients
around the country and whose work cannot be replaced by mail order
numbers and internet companies.
But, I believe that patients should be given their prescription for
contact lenses upon completion of an eye exam. The next step of this
process is to determine the best way to verify and then distribute the
lenses.
I am interested to learn the benefits and detriments of the
different ways to verify contact lens prescriptions--using either the
positive or passive forms of verification.
I look forward to hearing the testimony of our witnesses today. I
hope that we are able to provide a competitive market for consumers
while still protecting the interests and health of eye care patients. I
yield back the remainder of my time.
______
Prepared Statement of Hon. W.J. ``Billy'' Tauzin, Chairman. Committee
on Energy and Commerce
I'd like to begin by thanking the Chairman for holding this hearing
today on H.R. 2221, the ``Fairness to Contact Lens Consumers Act''. I
am an original sponsor of H.R. 2221, and I believe it is a strong piece
of consumer protection legislation that will help Americans and their
access to affordable eye care.
Back in the 1970s, the Federal Trade Commission enacted a rule that
required eye care professionals to provide patients with a copy of
their eyeglasses prescription. That rule was necessary because doctors
and optometrists would refuse to release prescriptions to consumers or
would condition release on the purchase of eyeglasses. While the
eyeglasses rule radically changed the competitive landscape--today
there is vibrant competition among eyeglasses providers--contact lenses
were not included in that rule.
Today we see the same competitive problems festering in the contact
lens marketplace as we saw in the eyeglasses market 25 years ago. In
fact, the anticompetitive behavior by eye care professionals caught the
attention of a number of state attorney's general who filed a complaint
against the American Optometric Association alleging a conspiracy to
eliminate the sale of contacts by pharmacies, mail order and other
alternative sellers, and a conspiracy to prevent the release of contact
lens prescriptions to consumers. This suit was settled, but it shows
the extent of distrust for how contact lenses are currently dispensed
by eye doctors and optometrists.
Unlike other areas of medicine where doctors are prohibited from
selling the drugs they prescribe, optometrists and eye doctors can and
do sell the contact lenses they prescribe. What this means is third
party sellers are forced to ask the eye doctors, their competitors, for
permission to make a sale. This sets up a classic conflict of interest
that robs the consumer of the ability to shop competitively for the
best price. Thankfully, H.R. 2221 is a step toward resolution.
H.R. 2221, the ``Fairness to Contact Lens Consumers Act'' takes the
necessary steps to remedy this stranglehold on contact lens
competition. This bill takes aim at all sides of the problem: it
mandates that doctors and optometrists release a consumer's contact
lens prescription, and cracks down on fly-by-night sellers who try to
sell contact lenses without a prescription.
H.R. 2221 not only sparks competition in the sale of contact
lenses, but it is consistent with the protection of consumers' health.
Price competition and service innovation in the contact lens market has
increased with the entry of third party sellers. With the increased
availability of affordable contact lenses, consumers will arguably
changes their lenses more frequently, resulting in increased ocular
health.
I look forward to hearing from our witnesses, and urge my
colleagues to support H.R. 2221. I yield back my time.
______
Prepared Statement of Hon. Hilda L. Solis, a Representative in Congress
from the State of California
Good afternoon. I would like to thank all the witnesses, especially
Mr. Howard Beales from the Federal Trade Commission, and Mr. Robert
Hubbard from the New York Attorney General's Office, for being here
today to discuss the issues relating to contact lens consumers
protection.
I believe it is important to recognize the tremendous growth not
only in the contact lens business, but also in the number of Americans
opting for contact lenses over glasses. Currently, there are over 36
million Americans wearing contact lenses. We must keep up with these
technological trends within medicine by implementing sound legislation
to address these advances.
I look forward to hearing from our distinguished group of witnesses
today, and to continue our efforts to discuss the issues relating to
contact lens consumer protection.
Thank you and I yield back the balance of my time.
Mr. Stearns. With that, we will move to the witness list.
We welcome Ms. Maria Martinez, appreciate you coming and
sharing your story with us; and, again, Mr. Howard Beales,
Director, Bureau of Consumer Protection, FTC;--thank him for
coming--Mr. Jonathan Coon, Chief Executive Officer, 1-800
Contacts; Dr. J. Pat Cummings, immediate Past President, the
American Optometric Association; Mr. Robert Hubbard, Director
of Litigation, Antitrust Bureau, Office of the New York
Attorney General; Ms. Ami Gadhia, Consumers Union; and Ms.
Peggy Venable, the State Director, Citizens for a Sound
Economy. I welcome all of you. And we'll start, Maria, with
you. And we appreciate your attendance.
STATEMENTS OF MARIA MARTINEZ; J. HOWARD BEALES III, DIRECTOR,
BUREAU OF CONSUMER PROTECTION, FEDERAL TRADE COMMISSION;
JONATHAN C. COON, CHIEF EXECUTIVE OFFICER, 1-800 CONTACTS; J.
PAT CUMMINGS, IMMEDIATE PAST PRESIDENT, AMERICAN OPTOMETRIC
ASSOCIATION; ROBERT L. HUBBARD, DIRECTOR OF LITIGATION,
ANTITRUST BUREAU, OFFICE OF THE NEW YORK ATTORNEY GENERAL; AMI
V. GADHIA, CONSUMERS UNION; AND PEGGY VENABLE, STATE DIRECTOR,
CITIZENS FOR A SOUND ECONOMY
Ms. Martinez. Thank you, chairman and committee members. It
is an honor to testify before you today.
My name is Maria Martinez. And I am from Austin, Texas. I
have been a contact lens wearer for over 20 years. I have
endured firsthand the effects of the lack of competition within
the contact lens market. I have paid up to and above $300 every
time I purchase a set of contact lenses and must say I am
looking for some relief. This, of course, frequently mandated
how often I replace my lenses. And I, of course, are limited
because the length that the prescription before it expires
lasts is 1 year.
I have a family of two children, and we are all contact
lens wearers in my family. What I would like to just voice here
is I am frustrated by the 1-year prescription period. Of
course, with three contact lens wearer in the family, it is far
too costly for me to keep up with.
In addition to this, I have interviewed other contact lens
wearers in my State just to find out their experiences. And I
found that they were denied the ability to obtain the
prescriptions. While for me it has been costly, I have not been
given a choice as to whether I could secure my prescription
and, therefore, go out and find it at a lower cost.
Some of the individuals that I talked to said that when
they tried to obtain the prescription from their eye care
provider, they were stalled until their prescription expired
and then they were unable to obtain it and had to go back to
obtain another prescription and pay the cost for another eye
exam. They felt they were treated deceptively in that way.
Other individuals I talked to eventually gave up and just
ultimately paid that higher price, rather than seek lenses from
an alternative provider.
A lady that I spoke to said that when she tried to get her
prescription for contact lenses, instead of a contact lens
prescription, we received a prescription for eyeglasses. And,
unfortunately, this individual was never given an exam for
eyeglasses with that particular physician. So there should not
have been a prescription for eyeglasses on file for her. So
ultimately she was forced to do without.
I just would urge this committee to support H.R. 2221 so
that it would promote competition in the contact lens market
and treat contact lens prescriptions equal to that of those for
eyeglasses.
Thank you.
Mr. Stearns. Thank you.
Mr. Beales, welcome.
STATEMENT OF J. HOWARD BEALES III
Mr. Beales. Thank you, Mr. Chairman, members of the
subcommittee. I am Howard Beales, the Director of the Federal
Trade Commission's Bureau of Consumer Protection. I am pleased
to present the views of the Commission this afternoon.
I am happy to provide comments on the Fairness to Contact
Lens Consumers Act. First, I would like to briefly discuss the
Commission's mission and our long history of activity in the
eye care industry. Then I will provide some specific comments
on the bill.
As the Federal Government's principal consumer protection
agency, the Commission has a long history of activity in the
eye care industry. Through law enforcement, advocacy before
other government agencies, and rulemaking, the Commission
promotes vigorous competition and consumer choice, thereby
increasing consumer welfare.
Many of the FTC's law enforcement efforts concerning eye
care have focused on ensuring that consumers have access to
truthful, non-misleading information about the eye care
products they need. For example, the Commission recently issued
final consent orders against two of the largest purveyors of
LASIK eye surgery services, the most common elective surgery in
the United States. In these cases, the Commission challenged as
unsubstantiated claims that LASIK surgery would eliminate the
need for glasses or contacts for life and that LASIK surgery
poses significantly less risk to patients' eye health than
wearing contact lenses or glasses. Our cases have enhanced the
ability of consumers to make better-informed choices concerning
eye care products.
The Commission also has pursued numerous advocacy
opportunities involving the eye care industry. Most recently,
in October of 2002, the Commission held a public workshop to
evaluate possible anti-competitive barriers to electronic
commerce in contact lenses and nine other industries.
Commission staff heard testimony from all sides of the
contact lens issue. The Commission staff will report on the
workshop and the extent to which anti-competitive barriers to
e-commerce exist in this industry.
Turning to the bill, the Commission supports the proposed
legislation's goal of promoting greater competition among
contact lens sellers and thereby enhancing consumer choice. We
have comments on three components of the bill.
First, the bill requires that eye care practitioners verify
a patient's contact lens prescription. The bill, however, does
not adopt a particular approach to verification. At its e-
commerce workshop, the Commission explored the costs and
benefits of two different approaches to prescription
verification: passive or active.
Proponents of passive verification favor this approach
because it allows the seller to presume verification if the eye
care practitioner does not take affirmative action to correct
any errors in the prescription. These proponents point to
difficulties with an active verification regime, such as a low
response rate or delayed responses by eye care practitioners.
By contrast, proponents of active verification systems
express concern that passive verification may allow sellers to
ship contact lenses even if the customer has an invalid or
incorrect prescription. According to proponents of active
verification, customers may face serious health risks if they
obtain and wear contact lenses based on such a prescription.
The Commission believes that the bill should identify with
specificity the type of verification system that would be
required. Absent such specificity, the Commission would be in
the difficult position of interpreting the law to determine
what types of verification systems would be acceptable. If the
bill directly and specifically addressed the issue of an
acceptable verification system, consumers would also receive
the bill's benefits more quickly than if the Commission first
had to compile information about various systems, analyze the
costs and benefits of these systems, and decide which systems
are acceptable.
Second, the bill also requires the FTC to undertake a study
and prepare a report within 9 months examining the strength of
competition in the market for prescription contact lenses. The
FTC study requirement involves issues well outside the
Commission's expertise, particularly the health effects of
different verification schemes, and would be very difficult to
complete within 9 months. Accordingly, the Commission
respectfully requests that it be eliminated.
Third, the bill would require that ophthalmologists and
optometrists release contact lens prescriptions to their
patients and any person designated to act on their patients'
behalf upon completion of a contact lens fitting. The
Commission believes that the availability of contact lens
prescriptions benefits consumers because it gives patients the
option of purchasing contact lenses from sellers other than the
eye care practitioner who wrote their prescription.
More than two-thirds of the States already require that
prescribers release contact lens prescriptions to patients.
Although it is unclear how frequently consumers do not obtain
their contact lens prescriptions, the Commission's experience
in this area suggests that the costs associated with a contact
lens prescription release requirement are likely to be quite
low. A requirement may not be necessary, but the Commission
does not oppose it.
Thank you for this opportunity to testify today. And I look
forward to answering any questions you may have.
[The prepared statement of J. Howard Beales III follows:]
Prepared Statement of Howard Beales, Director, Bureau of Consumer
Protection, Federal Trade Commission
i. introduction
Mr. Chairman and members of the Committee, I am Howard Beales,
Director of the Bureau of Consumer Protection at the Federal Trade
Commission (``Commission'' or ``FTC''). The Commission is pleased to
provide information concerning the contact lens industry and offer
comments on the Fairness to Contact Lens Consumers Act (H.R. 2221)
(``the bill''). I will discuss the Commission's mission and our long
history of activity in the eye care industry, and provide some specific
comments on the bill.1
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\1\ The views expressed in this statement represent the views of
the Commission. My oral statements and responses to any questions you
may have represent my own views, and not necessarily the views of the
Commission or any Commissioner.
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As the federal government's principal consumer protection agency,
the FTC's mission is to promote the efficient functioning of the
marketplace by enforcing laws against unfair or deceptive acts or
practices in or affecting commerce.2 Pursuant to its
statutory mandate, the Commission increases consumer choice by
promoting vigorous competition. The Commission has extensive experience
assessing the impact of regulation and business practices on
competition and consumers in many industries, including, as discussed
below, substantial experience with eyeglasses, contact lenses, and
other eye care goods and services.
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\2\ Federal Trade Commission Act, 15 U.S.C. 45, 52.
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ii. the contact lens marketplace
The contact lens market in the United States is a multi-billion
dollar market.3 Recent data indicate that nearly 36 million
Americans--almost 13% of all Americans--wear contact
lenses.4 There are numerous manufacturers of contact lenses
(e.g., Johnson & Johnson, Bausch & Lomb, and CIBA Vision) and many
different channels of distribution, including eye care practitioners
(e.g., ophthalmologists and optometrists), national and regional
optical chains, mass merchants (e.g., Wal-Mart and Costco), and mail
order and Internet firms.
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\3\ Annual sales estimates range from $1.95 billion to $3.5
billion.
\4\ See Health Products Research (VIS)--Annual 2000 Year-End
Consumer Contact Lens Survey (cited in ``Trends in Contact Lenses &
Lens Care,'' The Bausch & Lomb Annual Report to Vision Care
Professionals (Dec. 2001)).
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The contact lens market has undergone significant change in recent
years. In the past, for example, contact lenses were designed to last
for long periods of time, required daily removal, and involved
extensive cleaning regimens. Consumers generally purchased these lenses
from their eye care practitioners after an eye exam and lens fitting
and then replaced them, for example, when the prescription changed or a
contact lens was lost or damaged. Manufacturers had not developed
production methods for lenses that provided standardized reproduction.
Beginning in the late 1980s, lens manufacturers began to market and
sell ``disposable'' and ``frequent replacement'' soft contact lenses,
which are designed to be replaced daily, weekly, or monthly. Today, the
replacement soft contact lenses that a patient receives pursuant to a
prescription specifying brand and power will be the same, regardless of
whether the patient buys the lenses from an eye care practitioner or
another seller.
The development of standardized lenses has facilitated the growth
of sellers other than eye care practitioners. These sellers tend to
focus on the sale of replacement lenses for which an eye care
professional has already fitted the customer. Unlike many eye care
practitioners, these sellers do not sell eyeglasses, and do not
fabricate contact lenses or fit them to the eye. Their business
consists simply of shipping to customers lenses that come from the
manufacturer in sealed boxes labeled with the relevant specifications.
Many of these sellers are located in a single state but ship orders to
customers nationwide.
The advent of disposable soft contact lenses, followed by the
growth of ``alternative'' retail sources of contact lenses, including
mail order, pharmacy and mass merchants, has changed the market. Eye
care practitioners still write prescriptions, but now consumers
purchase more contact lenses with greater frequency. Moreover, they
have greater choice of sellers and means of delivery when they purchase
lenses.
Consumer choice in the contact lens market is expanding, and that
can have important benefits to consumers. Competition among contact
lens sellers benefits consumers through lower prices, greater
convenience, and improved product quality.
iii. overview of ftc's authority and history of activity in the eye
care industry
The Commission has a long history of activity in the eye care
industry--through law enforcement, advocacy before other government
agencies, and rulemaking. The underlying objective of these various
activities is to promote vigorous competition and consumer choice,
thereby increasing consumer welfare.
A. Law Enforcement
Many of the FTC's law enforcement efforts concerning eye care have
focused on ensuring that consumers have access to truthful, non-
misleading information about the eye care products they need. Until the
1980s many government boards and trade associations imposed
restrictions on the ability of eye care practitioners to provide
truthful and non-misleading advertising about their goods and services.
The Commission brought law enforcement actions challenging some of
these advertising restrictions as anticompetitive. For example, in
Massachusetts Board of Registration in Optometry,5 the
Commission challenged a state optometry board's regulations restricting
advertising of price discounts, the advertisement of affiliations
between optometrists and retail optical stores, and the use of
testimonials and similar forms of advertising. The FTC concluded that
these restrictions did not serve a legitimate purpose and were
anticompetitive, and ordered the board to cease and desist from
imposing such restrictions on advertising by optometrists. Removing
such advertising restrictions has allowed sellers of eye care goods and
services to compete more aggressively with each other.
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\5\ 110 F.T.C. 549, 606-08 (1988).
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Increased competition among sellers through advertising, however,
does not benefit consumers if the claims made in the ads are false or
misleading. To prevent such claims from being made in the marketplace,
the FTC sued sellers who have made deceptive advertising claims for eye
care products. For example, the Commission recently issued final
consent orders against two of the largest purveyors of LASIK eye
surgery services, the most common elective surgery in the United
States.6 In these cases, the Commission challenged as
unsubstantiated claims that LASIK surgery would eliminate the need for
glasses or contacts for life, and that LASIK surgery poses
significantly less risk to patients' ocular health than wearing contact
lenses or glasses. Our cases have enhanced the ability of consumers to
make better-informed choices concerning eye care products.
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\6\ LCA-Vision, Inc. d/b/a LasikPlus, Dkt. No. C-4083 (July 11,
2003) (consent) and The Laser Vision Institute, LLC, Dkt. No. C-4084
(July 11, 2003) (consent). LASIK is designed to reduce dependence on
eyeglasses and contact lenses for distance and near vision by changing
the shape of the cornea.
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B. Advocacy
The Commission also has pursued numerous advocacy opportunities
involving the eye care industry. In 2002, the Commission staff filed a
comment before the Connecticut Board of Examiners for Opticians
addressing whether state law requires that out-of-state sellers obtain
a license to sell contact lenses to the state's residents. FTC staff
argued that out-of-state sellers should not be subject to state
licensing requirements because the possible benefit to consumers from
increased state protection did not outweigh the likely negative effect
from decreased competition.7 Ultimately, the Board held that
state law did not require out-of-state sellers to obtain a license to
sell contact lenses to consumers.8
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\7\ FTC Staff Comment Before the Connecticut Board of Examiners for
Opticians (Mar. 27, 2002), available at .
\8\ Connecticut Board of Examiners for Opticians, In re: Petition
for Declaratory Ruling Concerning Sales of Contact Lenses, Declaratory
Ruling Memorandum of Decision (June 24, 2003).
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Similarly, in April 2003, the Commission submitted comments to the
Tennessee state legislature on proposed legislation that would have
restricted the types of agreements that optometrists can make with
commercial firms from which they lease space.9 The FTC
opposed these restrictions, explaining that they decrease competition
among sellers of eye care products, especially competition from chain
optical stores, without any offsetting benefits to consumers.
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\9\ Letter from Timothy J. Muris, Chairman, Federal Trade
Commission, to Hon. Ward Crutchfield, Senate Majority Leader, (Apr. 29,
2003), available at .
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In October 2002, the Commission held a public workshop to evaluate
possible anticompetitive barriers to e-commerce in contact lenses and
nine other industries.10 Commission staff heard testimony
from all sides of the contact lens issue, including eye care
practitioners, a major contact lens manufacturer, an online seller, a
traditional contact lens seller, and an economics professor. In
addition, Commission staff gathered evidence from a wide variety of
sources, such as empirical studies, court proceedings, state attorneys
general, and the Food and Drug Administration. Commission staff will
report on the information obtained in connection with the workshop and
the extent to which anticompetitive barriers to e-commerce exist in the
contact lens industry.
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\10\ 67 Fed. Reg. 48,472 (2002).
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c. rulemaking
In 1978, to increase competition in the sale of eyeglasses, the
Commission promulgated the Ophthalmic Practice Rule (``Prescription
Release Rule''). The Rule requires optometrists and ophthalmologists to
provide patients, at no extra cost, with a copy of their eyeglass
prescription after completion of an eye exam.11 The Rule was
based on the Commission's findings that many consumers were deterred
from comparison shopping for eyeglasses because they did not receive a
copy of their prescription. Some eye care practitioners refused to
release prescriptions, even when requested to do so, while others
charged an additional fee for release of a prescription. The Commission
also found a lack of consumer awareness that purchasing eyeglasses can
be separated from the process of obtaining an eye exam. As part of its
program of systematic analysis of its rules and guides, the Commission
currently is conducting a review of the overall costs and benefits of
the Prescription Release Rule.
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\11\ 16 C.F.R. Part 456. The original rule also prohibited bans on
nondeceptive advertising by vision care providers. That portion of the
rule was remanded to the Commission for further consideration in light
of the Supreme Court decision in Bates v. State Bar of Arizona, 433
U.S. 350 (1977). American Optometric Ass'n v. FTC, 626 F.2d 896 (D.C.
Cir. 1980). The Commission has since taken action against such
restrictions through administrative litigation, on a case-by-case
basis.
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One noteworthy issue is whether the Rule should be extended to
require eye care practitioners to release contact lens prescriptions to
patients.12 The Rule currently does not require an
optometrist or ophthalmologist to release a contact lens prescription
to a patient after an eye exam. The Commission previously has
considered this issue but declined to extend the Rule to contact
lenses. In 1989, the Commission found there was not sufficient reliable
evidence from which to conclude that the practice of not releasing
contact lens prescriptions upon request was prevalent.13 In
1995, in response to a petition for rulemaking, the Commission reached
a similar conclusion after conducting a survey on the extent to which
patients could obtain their contact lens prescriptions.14
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\12\ See Request for Public Comments, 62 Fed. Reg. 15,865 (Apr. 3,
1997).
\13\ Ophthalmic Practice Rules, Final Trade Regulation Rule, 54
Fed. Reg. 10,285, 10,299, 10,303 (Mar. 13, 1989).
\14\ Letter from Federal Trade Commission to H. Jeff McLeod, Re:
Petition to Initiate Rulemaking to Require the Release of the Contact
Lens Prescription (June 29, 1995) (on FTC Public Record, Document No.
B174817).
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Commission staff is monitoring the significant ongoing changes in
the contact lens marketplace relevant to issues raised in the rule
review, including the growth of alternate sellers of replacement
contact lenses, state legislation requiring contact lens prescription
release and verification, and proposed federal legislation addressing
prescription release and verification issues.
iv. h.r. 2221: the ``fairness to contact lens consumers act''
Drawing on its experience with the eye care industry, the
Commission welcomes the opportunity to provide its views on The
Fairness to Contact Lens Consumers Act. The bill would require that
ophthalmologists and optometrists release contact lens prescriptions to
their patients and verify contact lens prescriptions for Internet
sellers and other third parties. The bill would provide for FTC
enforcement of these requirements. The Commission supports the proposed
legislation's goal of promoting greater competition among contact lens
sellers and thereby enhancing consumer choice. We have comments on
three components of the bill.
A. Prescription Verification
First, a central requirement of the bill is that eye care
practitioners verify a patient's contact lens prescription ``as
directed by any person designated to act on behalf of the patient.''
15 This provision appears aimed at helping patients who seek
to purchase contact lenses from a seller other than their own eye care
practitioner. Eye care practitioners would be prohibited from refusing
to verify prescription information to a third-party seller, such as a
mail order or Internet seller, thus facilitating competition between
eye care practitioners and third-party sellers.
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\15\ H.R. 2221, Sec. 2(a)(2).
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The bill does not impose a particular approach to verification.
There are two primary approaches to verification: ``passive'' and
``active'' verification.16 Under a passive verification
system, a third-party seller must notify the eye care practitioner of
its customer's request to purchase contact lenses and inform the
practitioner what prescription information the customer has provided.
Unless the eye care practitioner affirmatively notifies the seller
within a specified time period that the prescription is incorrect,
expired, or otherwise problematic, the seller may presume that the
prescription is correct and valid and complete the sale to the patient.
By contrast, under an active verification system, the third-party
seller must wait for affirmative confirmation from the prescriber that
the prescription is correct and valid before it can complete the sale.
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\16\ States have taken different approaches to verification of
prescriptions. California, for example, has adopted a passive
verification regime, Cal. Bus. & Prof. Code 2546.6(a), while Texas
has adopted an active verification system. Texas statute Sec. 351.607.;
Tex Adm. Code. 279.2(e).
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At its E-Commerce Workshop, the Commission explored the costs and
benefits of these two approaches to prescription
verification.17 Proponents of passive verification
(including many alternative sellers of contact lenses like mail order
and Internet sellers) favor this approach because it allows the seller
to presume verification if the eye care practitioner does not take
affirmative action to correct any errors in the prescription. These
proponents point to difficulties with an active verification regime,
such as low response rates or delayed responses by eye care
practitioners who have an incentive to impede verification so that
their patients will continue to buy contact lenses from them. By
contrast, proponents of active verification (including some groups
representing eye care practitioners) express concern that passive
verification allows sellers to ship contact lenses even if the customer
has an invalid or incorrect prescription. According to proponents of
active verification, customers may face serious health risks if they
obtain and wear contact lenses based on an invalid or incorrect
prescription.
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\17\ The choice of a time period in verification systems is a
contentious issue, with Internet and mail order sellers generally
seeking shorter time periods and eye care practitioners typically
seeking longer time periods.
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The Commission believes that the bill should identify with
specificity the type of verification system that would be required.
Absent such specificity, the Commission would be in the difficult
position of interpreting the law to determine what types of
verification systems would be acceptable. If the bill directly and
specifically addressed the issue of an acceptable verification system,
consumers also would receive the bill's benefits more quickly than if
the Commission first had to compile information about various systems,
analyze the costs and benefits of these systems, and decide which
systems are acceptable.
B. FTC Study
The bill also requires that the FTC undertake a study and prepare a
report, within nine months, examining the strength of competition in
the market for prescription contact lenses. The study would address
several specific issues such as: the merits of active versus passive
verification; compliance with and enforcement of state verification
laws; and the effects of these state laws on competition and ocular
health. In addition, the study would address the costs and benefits of
the practice of writing prescriptions for ``private label lenses,''
that is, prescriptions written for contact lenses that only the
prescribing eye care practitioner sells.
The FTC study requirement implicates issues well outside the
Commission's expertise, such as the effect of state verification laws
on ocular health. It also would be very difficult to complete within
nine months the broad study that the bill would require. Given the
scope and burden of the study requirement in the bill, the Commission
respectfully requests that it be eliminated.
C. Prescription Release Requirement
Third, the bill would require that ophthalmologists and
optometrists release contact lens prescriptions to their patients, and
any person designated to act on their behalf, upon completion of a
contact lens fitting.18 The Commission believes that the
availability of contact lens prescriptions benefits consumers because
it gives patients the option of purchasing contact lenses from sellers
other than the eye care practitioner who wrote their
prescription.19
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\18\ H.R. 2221, Sec. 2(a).
\19\ Release of prescriptions by eye care practitioners to agents
of consumers, such as mail order and Internet sellers, also may promote
competition.
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More than two-thirds of the states already require that prescribers
release contact lens prescriptions to patients.20 Some
states require the release of prescriptions upon request by the
patient, while other states require release automatically, regardless
of whether the patient requests it. Moreover, a survey conducted by the
Commission in 1995 indicated that most consumers who requested their
prescription were able to obtain it.21 Nevertheless, there
is anecdotal evidence that some patients have been unable to obtain a
copy of their contact lens prescription.22
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\20\ We understand these states to be: Alabama, Arizona, Arkansas,
California, Colorado, Connecticut, Delaware, Florida, Georgia, Indiana,
Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts,
Minnesota, Nebraska, New Hampshire, New Jersey, New Mexico, New York,
North Carolina, Ohio, Oklahoma, Oregon, South Dakota, Texas, Utah,
Vermont, Virginia, Washington, Wisconsin, and Wyoming. Some states
require prescription release by statute, while others do so through
rules.
\21\ Bruskin/Goldring Research, Contact Lenses, prepared for
Federal Trade Commission (Feb. 1995) (available on the FTC public
record, Document No. B174829). However, the Commission has not studied
the extent to which agents of consumers have been unable to obtain
release of prescriptions.
\22\ In addition, we note that the Attorneys General of 31 states
filed suit in 1996 alleging, in part, a conspiracy among practitioners
and their trade associations to prevent the release of contact lens
prescriptions to consumers. See In re Disposable Contact Lens Antitrust
Litigation, No. 94-MDL 1030-J-20A (M.D. Fla.). The case ultimately
settled.
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Although it is unclear to what extent consumers currently do not
obtain their contact lens prescriptions, the Commission's experience
with the prescription release requirements for eyeglasses suggests that
the costs associated with a contact lens prescription release
requirement are likely to be quite low. Accordingly, the FTC does not
oppose such a requirement.23
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\23\ The Commission also recommends that the bill clarify which
state law would apply for purposes of determining the expiration date
for contact lens prescriptions. See H.R. 2221, Sec. 3(a). As written,
the state law ``involved'' could be interpreted many ways, including to
mean the state where the prescription was written, the state where the
prescription was filled, or the state where the patient lives.
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v. conclusion
The Commission appreciates this opportunity to present its views on
the Fairness to Contact Lens Consumers Act, H.R. 2221. I look forward
to answering any questions you may have.
Mr. Stearns. Mr. Coon, we welcome your opening statement.
STATEMENT OF JONATHAN COON
Mr. Coon. Thank you, Mr. Chairman and members of the
committee, for investing the time to learn more about this
issue that affects 35 million Americans and the 3 million
customers that purchase from our company.
The core issue here really is that eye doctors sell what
they prescribe. That's the key thing that differentiates this
area of health care from almost any other area of health care.
Eye doctors sell and profit from the products that they write
prescriptions for. And that creates quite a few conflicts for
the consumer.
If eye doctors didn't sell what they prescribe, consumers
wouldn't need the protections that are in the Burr bill, H.R.
2221. The verification process, for instance, with medical
doctors and pharmacies isn't defined. And it doesn't need to be
defined because they don't compete with each other. Medical
doctors don't sell drugs. Medical doctors don't own pharmacies.
People don't buy medicine from their doctors. There aren't
competing sellers for the doctor because the doctor doesn't
compete.
So when somebody goes to a pharmacy to get a prescription
filled, there's no trouble getting a prescription released
because a doctor has no motivation not to release the
prescription. And there's no trouble with the pharmacy getting
a response from a medical doctor because a medical doctor has
no economic motivation to delay or to not respond to the
pharmacy because, again, the medical doctor doesn't own his own
pharmacy.
I think this conflict is really best demonstrated by some
of the industry advertisements that we see. We would like to
submit some of these for the record. Some of these statements
are things that are not said publicly by the optometric trade,
but they are said in their private trade journals.
This is an example called ``Winning the War Against Mail
Order Contact Lenses.'' A key quote from here says, ``When you
get a telephone inquiry for a patient's contact lens
prescription, recognize it as an opportunity for a sale.'' Now,
when my medical doctor gets a call from my pharmacy, I don't
think he recognizes it as an opportunity to make a sale because
he doesn't sell drugs.
Another ad talks about the focus on making money and
profit. This is from a manufacturer that sells their products
only to eye doctors who prescribe them. The headline of the ad
says, ``Let's See. You'll Make More Money.'' The line at the
bottom says, ``Since our lenses are only available through your
practice, you will get what you are looking for: increased
patient loyalty and greater profitability.
Now, drugs are not marketed to doctors on the basis that a
doctor will make more profit as a result of writing a
prescription for that drug. I think these just kind of
highlight some of the differences. And I will go through just a
couple of more very quickly.
In this ad, which is actually particularly humorous if you
only look at one, this is a pretty good one. It says, ``Every
Tom, Dick, and Harry is offering your patients low-priced
disposables. The system is broken'' as if competitors offering
lower prices, there is something wrong with the system when
that is happening.
And this last one really highlights verification. When our
company gets an order from the consumer, that consumer is
essentially asking their eye doctor to grant permission to a
competitor of the eye doctor to make a sale to that consumer.
This is highlighted here, a quote from a doctor, an eye doctor,
that says, ``We would get calls from patients in 1-800-CONTACTS
asking us for their contact lens prescriptions. I wanted to use
another strategy to stop that from happening.'' So, again, my
medical doctor doesn't want to stop pharmacies from calling a
medical doctor because that is part of the health care service
that my doctor provides to me.
Now, I would say that, despite articles and ads like these
and other anti-competitive tactics, there is a lot of common
ground here. We agree on release, that consumers should have a
right to their prescription. We agree that sellers should
verify prescriptions. And we agree that eye doctors should
respond to those verification requests. Where we disagree is on
verification, particularly how long the consumer should wait
for an eye doctor to respond to a verification request from a
competing seller.
I need to emphasize how important verification is, in
addition to release, because most of our consumers need their
prescription verified. The typical experience for a customer is
that they call; they read their information, which is in the
box. Lenses typically, like these, only come in one size. This
is one size fits all. It comes in different powers depending on
how much visual crutch you need, but it only comes in one size.
And they'll read us their brand, their size, and their power
off the package.
Now, we need to verify that prescription with the doctor's
office. We require a doctor's valid name and phone number. And
we contact the doctor's office to verify the prescription.
Meanwhile, the consumer is waiting.
There are really two different systems for verification
that I think you will hear described today. One is positive
verification. Under that system, the consumer waits
indefinitely for an eye doctor to respond to a competitor's
request to sell to their customer. And under a presumed
verification, the consumer waits a defined period of time after
which if the doctor hasn't corrected any errors or indicated
that there is a problem, the consumer is able to get her
lenses.
Now, in either system, in either system, the eye doctor can
stop a consumer from getting lenses if the prescription is
invalid or if there is an error with the prescription. Under
one system, the doctor can stop orders for any reason under a
positive verification system by doing nothing at all and simply
ignoring the request.
Under a presumed verification system, which is the law in
California and is our system Nationwide with Johnson and
Johnson on 40 percent of our orders, the doctor actually has to
actively respond to say if there's a problem with the order.
But under either case, a consumer with an invalid prescription,
the doctor can respond.
The results of the two systems are dramatically different.
We heard from one consumer from Texas. We have had over 50,000
consumers denied their right to purchase from us in the last
year for no other reason--and this is over half our orders in
the State of Texas--denied for no other reason than that their
eye doctor refused to respond to a written prescription request
that we sent by fax and had confirmed.
So the other system is California. It's a presumed system.
It's the law in the State and--I'm over on time. So I'll
prepare to wrap up here pretty quick.
Mr. Stearns. We'll just have you summarize.
Mr. Coon. Sorry. Well, some of the things that I would like
to, I will just submit some of the things that we have.
Mr. Stearns. Yes. And by unanimous consent, we'll make it--
--
Mr. Coon. Yes. We'll submit some lenses and then just point
out--I'll submit the advertisements. There's also a letter from
the California Optometric Association endorsing presumed
verification as a safe and reasonable standard that strikes a
balance between access and accountability. And I'll submit
those for the record.
Mr. Stearns. All right. We will make those part of the
record. By unanimous consent, so ordered.
[The prepared statement of Jonathan Coon and additional
submitted material follows:]
Prepared Statement of Jonathan Coon, Chief Executive Officer, 1-800
CONTACTS, Inc.
Mr. Chairman and Members of the Subcommittee, my name is Jonathan
Coon, CEO of 1-800 CONTACTS. Our company sells replacement contact
lenses to consumers through an Internet web site and a toll-free
telephone number. I appreciate the opportunity to appear before the
Subcommittee today.
In general, we believe that:
1. Contact lens wearers should have the right to a copy of their
contact lens prescription--without asking for it;
2. Contact lens wearers should have the freedom to choose where they
purchase their contact lenses;
3. Contact lens wearers should be able to receive their replacement
contact lenses as quickly as practical, and their chosen
retailer and their eye care professional should be expected to
cooperate to allow this to happen, and;
4. The means by which the sale of contact lenses are regulated should
be updated to account for the changes that have taken place in
last 25 years in the development, manufacture and marketing of
contact lenses.
The legislation proposed by Rep. Richard Burr (H.R. 2221) will
promote these goals, and will have a direct and positive impact on the
lives--and pocket books--of the 35 million Americans who spend more
than $3.5 billion every year on contacts.
For those Members of the Subcommittee who are not familiar with
contact lenses, I have brought a few samples. When contact lenses first
became available to consumers, lenses were hard and custom made to each
patient's unique specifications. Today the vast majority of Americans
who wear contact lenses wear soft disposable lenses requiring no
customization. Consumers most often buy these mass-produced lenses four
6-packs at a time. Daily disposable customers commonly buy 180 or 360
lenses at a time.
As you can see, contact lenses are mass produced and disposable. It
is an industry that has changed dramatically over the last 25 years.
The fastest growing segment of the market are lenses that are thrown
away every day--after a single use. Toll free numbers, overnight
delivery, and the Internet have made it possible for consumers to order
replacement lenses quickly and have the exact same lenses delivered to
their door that they used to have to drive to purchase and pick up from
their eye doctor.
Contacts have changed from custom made to mass produced. The
regulations surrounding the sale of contacts have stayed the same.
Contact lens wearers have no right under federal law to automatically
receive a copy of their own prescription--a right eyeglass wearers have
enjoyed for over 25 years. Contact lenses represent one of the few
remaining areas of health care where medical professionals can both
prescribe and sell the products they prescribe--an inherent conflict of
interest. As a result, for many Americans, contact lenses are too
expensive, and too difficult to replace.
Those opposed to granting contact lens wearers rights similar to
those enjoyed by eyeglass wearers frequently cite health concerns as
their justification. There are risks associated with wearing contact
lenses, but those risks have nothing do to with where the lenses are
purchased. An investigation conducted by state attorneys general
concluded, ``purchasers from alternative channels have had no greater
ocular health problems than purchasers from ECPs [eye care
professionals].'' In settling anti-trust claims brought by 32 state
attorneys general, the American Optometric Association (AOA)
specifically agreed it could not represent that purchasing contact
lenses from alternative distributors posed increased health risks. The
attorneys general argued the opposite--that lower prices for and easier
access to replacement contact lenses encourages more frequent
replacement and improved ocular health.
Mr. Chairman, I ask that copies of the attorneys general
investigation and of the consent decree signed by the AOA be included
with my testimony.
Mr. Chairman, we support H.R. 2221 as an important first step for
America's approximately 35 million contact lens wearers.
1. It will grant every American who wears contact lenses the
automatic right to a copy of his or her own contact lens prescription.
2. It will promote competition and ocular health by making contacts
cheaper and easier to replace.
3. It will begin to protect consumers from the inherent conflict of
interest created when eye care professionals both prescribe and sell
contact lenses.
The core principle behind this legislation is that every American
should have a right to a copy of his or her contact lens prescription
without having to ask for it. This makes sense. Having a copy of one's
prescription is the consumer's ``ticket'' to lower prices and better
service.
In the majority of states, consumers have no automatic right to
their contact lens prescription. A survey conducted by The Detroit Free
Press indicates that consumers in the Detroit region often have a
difficult time obtaining their prescriptions. Of fifty (50)
optometrists surveyed, only one would release contact lens
prescriptions to patients after an exam. Fifty-four (54) percent of
optometry offices stated that they never release contact lens
prescriptions to patients.
Under federal law, every American has an automatic right to a copy
of his or her own eyeglass prescription--without having to ask for it.
When the rule was adopted in 1978, contact lenses were custom-made, and
not included. H.R. 2221 would provide equal rights for contact lens
wearers by providing them with an automatic right to a copy of their
prescription.
However, having a copy of the prescription is meaningless if the
retailer chosen by the consumer cannot get the prescription verified.
For example, when consumers seek to refill their prescriptions for
medicines, its generally a simple process--the consumer goes to his or
her local pharmacy, the pharmacy calls into the prescribing physician
and the physician's office then promptly confirms, corrects or rejects
the refill. That's the way it should work with refills of contact lens
prescriptions--but in most cases it does not.
Since eye care professionals both prescribe and sell contact
lenses, verification amounts to the consumer asking their doctor's
permission to buy lenses from a competitor. This inherent conflict of
interest results in eye doctors ignoring our written verification
requests more than half the time. Doctors respond quickly to tell us if
there is a problem with the prescription and more slowly or not at all
if there is no problem with the prescription.
There are basically two different verification systems.
Indefinite vs. Defined:
1. ``Indefinite verification''--sometimes referred to by eye
doctors as ``positive verification,'' this system requires a competing
seller to wait indefinitely for the eye doctor (who sells contacts) to
respond to the verification request. The seller must wait until a
response is received although no time period is defined for the doctor
to respond.
2. ``Defined verification''--sometimes referred to as ``passive or
presumed verification'' this system defines how long an eye doctor has
to respond to a verification request when a consumer chooses to
purchase from a seller other than that same eye doctor. This system
requires a seller to seek verification from the prescriber and gives
the prescriber a reasonable time period in which to reply. If the
prescriber tells the seller within that time period that the
prescription is expired or invalid, the seller must cancel the order.
If the prescriber does not respond to the seller within the defined
time period, the seller can rely on the prescription information
provided by the consumer and fill the order.
Eye doctors who sell contacts say the verification time period does
not need to be defined.
Sellers who are not eye doctors say the time period should be
defined.
It's easy to explain the two positions:
Sellers who are not eye doctors must ask a competing seller of
contacts for permission to make a sale.
Eye doctors who sell contacts ask themselves.
An indefinite verification system can work where the prescriber has
no conflict of interest. For example, the verification process between
medical doctors and pharmacies is not defined. This system works
despite the lack of defined rules because medical doctors do not sell
drugs and pharmacies do not write prescriptions. The relationship is
defined in such a way that the response time can be indefinite because
there is no reason for the doctor not to cooperate. Pharmacies are not
asking a competitor for permission to fill an order. Medical doctors
are not losing income by cooperating with pharmacies.
Where indefinite time period (or ``positive verification'') systems
have been implemented for the sale of replacement contact lenses, the
result has been widespread consumer dissatisfaction. Thousands of
consumers wait so long for a verification response that more than half
ultimately cancel their orders. Many of these customers give up and go
back to the doctor to purchase lenses. Many just keep wearing their old
lenses. We also see a growing number going to over-the-border online
companies that require no verification.
In Texas alone, where an indefinite time period system has been in
place for more than a year, our company has canceled more than 40,000
customer orders solely for non-response by the eye doctor. Consumers
have filed more than 4,300 hand-signed complaints with the optometry
board. Additional complaints have been filed by consumer groups and
even by eye doctors themselves. The optometry board (made up of
optometrists) has, in my opinion, taken no meaningful action to address
the consumer complaints. The result has been an unmitigated disaster
for Texas consumers with more than half of all online orders canceled
simply because the eye doctor never responds--in any time period.
A defined time period system is similar to what the FTC staff
called for in comments before the Connecticut Opticians Board, in which
they stated ``a valid prescription, communicated to the seller by the
patient, can be presumed verified if the doctor is contacted and given
sufficient opportunity to correct any errors.''
This compromise system was enacted into law in California last
year. The system was developed with the involvement of
ophthalmologists, optometrists, consumer groups, the California Medical
Board, and the California Optometric Association. In their written
statement supporting the bill, the California Optometric Association
concluded that the law ``supports safe and responsible patient access
to contact lens prescriptions'' and ``strikes a reasonable balance
between access and accountability.'' Our company has processed more
than 100,000 orders in California since the system was activated. We
are not aware of any complaints being received by the medical board
from consumers, online sellers, or eye doctors.
We agree with the California Optometric Association, and believe
that a verification system with a defined time limit is a reasonable
compromise that would work well nationwide.
Mr. Chairman, thank you for the opportunity to testify. I would be
pleased to answer any questions you may have.
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Mr. Stearns. Dr. Cummings, welcome.
STATEMENT OF J. PAT CUMMINGS
Mr. Cummings. Thank you. Mr. Chairman, I am Pat Cummings,
immediate past president of the American Optometric Association
and a private practice optometrist from Sheridan, Wyoming. I
appreciate the opportunity to appear today to discuss H.R.
2221, the Fairness to Contact Lens Consumers Act, on behalf of
AOA and its 34,000 members.
H.R. 2221 would require that doctors provide contact lens
prescriptions to patients and respond to requests to verify the
prescriptions by others. Let me state right away that the AOA
supports this consumer right to receive their prescription and
have it verified to a third party. We believe that the vast
majority of doctors do provide patients with this information.
Nonetheless, we recognize that all patients should have equal
access to this information.
The primary issue for AOA and its members is not where
patients purchase replacement lenses. It is simply to assure
two things: first, that the process for verifying the
prescription provided the doctor with all the information
required so that the doctor may properly and efficiently
respond to the request; and, second, that the lenses are
provided to the patient only when the prescription has, in
fact, been positively verified. It is important to note that we
believe this process should apply to all sellers of lenses,
including private practitioners, optical chains, and others.
Current methods used by sellers to verify prescriptions
fall into one of three basic categories: fax requests,
automated phone calls, or a simple statement on a Web site that
says, ``Placing an order confirms that a valid prescription
exists,'' which is, in fact, no verification at all.
My written statement contains examples of problems with
each of these methods sent to me by colleagues. I would just
like to summarize them briefly; first, in a recent fax
situation which resulted in a seller encouraging a patient to
file a complaint with the State board, despite the fact that
the doctor had responded to the fax request not once but twice.
This is not an unusual occurrence. I have been told similar
stories by numerous colleagues over the past year.
Another member described an automated phone message that
resulted in a non-compliant response, no matter what choice the
doctor made. Again, this is a story I have heard repeatedly
from colleagues in the past year. And it raises two basic
concerns.
First, it places a doctor legitimately attempting to comply
with a verification request in a potentially adversarial
situation with a patient as well as being incorrectly reported
to a State board. Second, it raises the very real possibility
that lenses were provided to a patient with no knowledge of
whether a valid prescription exists.
Finally, Mr. Chairman, there are Web sites who make no
attempt at all to verify that a prescription actually exists.
Two such examples are Vision Direct and Coastal Contacts. Just
last week I received a note from a colleague describing an
adverse event for a patient who obtained lenses off one of
these sites. While the ultimate outcome was good, it could have
resulted in severe vision loss, all because the lenses were
provided without a prescription, without adequate instruction,
and without medical supervision.
Adding a provision to H.R. 2221, requiring sellers to
provide doctors with basic information will address two
important issues raised by these examples. First, it will
reduce the number of lenses being provided inappropriately
without a prescription. And, second, it will allow doctors to
respond more efficiently to requests and minimize the chance
that they will be unfairly subjected to potential substantial
penalties. It would also promote fair competition among sellers
because some sellers will no longer have the advantage of
disregarding the need to contact a doctor to validate the
prescription.
Our second concern is that lenses should be sold only when
the existence of a valid prescription is positively verified by
the doctor. Contact lenses are prescription medical devices
regulated by the Food and Drug Administration. In fact, the FDA
has published a consumer advisory telling consumers not to
order contact lenses by mail, phone, or on the Internet without
a current prescription because of health risks associated with
contact lens wear.
A 2002 FTC staff document concluding the primary health
care concerned with contact lenses appears to be ensuring that
contact lens wearers return to their doctors regularly for eye
examinations. Customers incur health risks if they forego
regular eye exams that would allow the optometrist or
ophthalmologist to spot emerging health problems in the early
stages.
The only verification system consistent with the status of
contact lenses as FDA-regulated devices and the only way to be
absolutely certain that these risks are eliminated is one in
which the seller either has a copy of the prescription or has
it positively verified by the doctor.
If the concern is that doctors will not comply, then make
the penalties more severe. Having served in both State and
National positions for many years, my strong sense is that the
penalties called for in H.R. 2221 are more than sufficient to
capture the attention of the few practitioners who otherwise
may not comply, but we don't have any qualms about increasing
them substantially if some feel it necessary.
Again, Mr. Chairman, let me emphasize that we support the
intent of H.R. 2221 to provide patients with their contact lens
prescriptions and to require doctors to respond to requests to
verify those prescriptions.
Thank you.
[The prepared statement of J. Pat Cummings follows:]
Prepared Statement of J. Pat Cummings, O.D., Immediate Past President,
American Optometric Association
Mr. Chairman, I am Pat Cummings, Immediate Past President of the
American Optometric Association (AOA) and a private practice
optometrist from Sheridan, Wyoming. I appreciate the opportunity to
appear today to discuss HR 2221, the ``Fairness to Contact Lens
Consumers Act,'' on behalf of AOA and its 34,000 members.
HR 2221 would require that doctors provide contact lens
prescriptions to patients following a fitting period, and respond to
requests to verify the prescription by others acting on behalf of the
patient. Let me state right away that the AOA supports this consumer
right to receive their prescription and have it verified to a third
party. We believe that the vast majority of doctors do provide patients
with this information; 35 states have prescription release provisions,
and the Federal Trade Commission (FTC) found in a 1995 study that 92
percent of patients who asked for their prescriptions received them.
Notwithstanding those figures, we recognize that all patients should
have equal access to this information, and we do support the intent of
HR 2221 to provide it to them.
The primary issue for AOA and its members is not where patients
purchase replacement lenses. It is simply to assure two things: first,
that the process for verifying the prescription upon which the purchase
is based provides the doctor with all the pertinent patient information
required, so that the doctor may properly and efficiently respond to
the request; and second, that lenses are provided to patients only when
the prescription has in fact been positively verified. It is important
to note that we believe that positive verification should apply to all
sellers of lenses, including private practitioners, optical chains and
others.
Current methods used by sellers to verify prescriptions fall into
one of three basic categories:
FAX requests, which may or may not include adequate information about
the patient for the doctor to accurately respond, and may not
in fact be handled appropriately when the doctor does respond.
For example, the seller may tell the patient the doctor hasn't
responded when they have, or conversely may provide the patient
with lenses when the doctor has indicated no valid prescription
exists.
Automated phone calls, which have proven difficult if not impossible
for doctors to respond to.
A simple statement on a website that says placing an order confirms
that a valid prescription exists, which is in fact no
verification at all.
Let me provide examples of problems associated with each of these
methods.
Doctors have been accused of being unresponsive to requests for
verification. One of our members has sent us the following account of a
recent FAX situation addressing this issue as follows: ``Patient X is a
long-term patient and contact lens wearer. She has often chosen to
receive lenses from another supplier. I examined her two weeks ago and
found normal eye health and good contact lens wear. We received a fax
from 1-800Contacts a few days later asking for prescription
verification. We returned the fax with the appropriate information
immediately. Two days later we received a second FAX for the same
information. My staff took time out of a busy day to reply, this time
with a note stating that this was our second response. The patient then
called my office a few days later stating she had received a note from
1-800Contacts claiming we would not release her contact lens
prescription information. Further, they requested she fill out a
complaint form and send it to the State Board of Examiners in
Optometry. We subsequently called 1-800Contacts. They informed us they
had made a mistake and had indeed received both replies of
verification. They said they would contact the patient to inform her we
were in compliance. Then, we received a third FAX for the same patient
looking for the same verification.'' This is not an unusual occurrence;
I have been told similar stories by numerous colleagues over the past
year.
Another member sent the following on the automated message method:
``At 9:15AM on August 13, 2003, we received an automated call from 1-
800Contacts. The call asked if we would be compliant in processing a
request to verify a prescription; if so press 1, if not press 2. When I
pressed 1 the recording said we will note that you will not be
compliant with your patients' request and the call was ended. I
verified that I had pressed 1 on the phone screen. No patient name or
prescription was given.'' Again, this is a story I have heard
repeatedly from colleagues in the past year, and it raises two basic
concerns. First it places a doctor legitimately attempting to comply
with a verification request in a potentially adversarial situation with
a patient as well as being incorrectly reported to a State Board;
second it raises the very real possibility that lenses were provided to
a patient with no knowledge of whether a valid prescription exists
simply on the basis that some request was made and no response
received.
Finally, Mr. Chairman, there are the websites who make no attempt
at all to verify that a prescription actually exists. Two such examples
are Vision Direct and Coastal Contacts. Both these sites simply say in
small print that by placing an order you confirm you are a successful
contact lens wearer with a valid prescription. There is no request for
doctor information and no attempt to verify the existence of a valid
prescription.
Just last week I received the following from a colleague describing
an adverse event for a patient who obtained lenses off of one of these
sites as follows: ``Patient X has been ordering his contact lenses off
the internet from Vision Direct. He was wearing Johnson/Johnson Acuvue
lenses extended wear. While ordering a new supply of lenses from Vision
Direct he inquired about the new 30-day continuous wear lenses. They
informed him that they did indeed have the lenses and were more than
happy to supply the lenses to him. Vision Direct had never received a
valid prescription from an optometrist or an ophthalmologist but had
just started mailing lenses to him from the information which he
provided to them from the lens parameters found on the contact lens
boxes. They also changed him to the Focus Night/Day lenses without
valid authorization. Worse yet, they never provided him with any
information as to how long the lenses could be worn or how frequently
the lenses needed to be changed to a new pair. Needless to say, without
any direction, he started wearing the lenses anywhere from two to three
months continually before he would change to a new pair of lenses. He
would only change them when his vision became blurred or when the
lenses started irritating his eyes. He came to my office complaining of
very blurred vision and severe pain in his right eye. From my
examination, I determined that he had developed very serious corneal
stromal edema as well as a superficial keratitis. After three weeks of
medical treatment, I was able to restore his vision back to the 20/20
level. These lenses were provided to this gentleman without a proper
valid prescription or proper medical supervision. Thankfully the
outcome in this case was good, however, it very possibly could have
ended with severe vision loss.''
Adding a simple provision to HR 2221 requiring sellers to provide
doctors with basic information will address two important issues raised
by these examples--first, it will reduce the number of lenses being
provided inappropriately without a prescription; and second, it will
allow doctors to respond more efficiently to requests and minimize the
chance that they will be unfairly subjected to potential substantial
penalties. In addition, this will actually promote fair competition
among sellers, because some sellers will no longer have the advantage
of disregarding the need for a valid prescription. This we believe is a
reasonable approach that improves the bill with no undue burden on any
party.
Our second concern is that lenses should be sold only when the
existence of a valid, unexpired prescription is positively verified by
the doctor. Why is this so important? Contact lenses are prescription
medical devices regulated by the Food and Drug Administration. They can
only be dispensed to patients with a valid, current prescription. In
fact, the FDA has published a consumer advisory telling consumers not
to order contact lenses by mail, phone or on the internet without a
current prescription, because of health risks associated with contact
lens wear. As the Federal Trade Commission staff pointed out in
comments to the Connecticut Board of Examiners for Opticians in May
2002 there are significant health issues concerning the sale of contact
lenses, primary among them being ensuring that contact lens wearers
return to their doctors for regular eye examinations. The staff
document correctly concludes, ``The primary health care concern with
contact lenses appears to be ensuring that contact lens wearers return
to their doctors regularly for eye examinations. Customers incur health
risks if they forego regular eye exams that would allow the optometrist
or ophthalmologist to spot emerging health problems in the early
stages.'' As noted in my previous example, that is a very real risk
when lenses are provided without a properly verified prescription.
The only appropriate verification system consistent with the status
of contact lenses as FDA regulated devices and the only way to be
absolutely certain that these risks are eliminated, is one in which the
seller either has a copy of the prescription or has it positively
verified by the doctor. Anything less is subject to the vagaries of
both technical and human error. You can't call the pharmacy and get a
drug prescription filled unless the pharmacy has a copy of a valid
prescription on file or gets approval from the doctor. It should be no
different for contact lenses.
If the concern is that doctors will not comply, then make the
penalties more severe. Having served in both state and national
positions for many years, my strong sense is the penalties called for
in HR 2221 are more than sufficient to capture the attention of the few
practitioners who otherwise may not comply, but we don't have any
qualms about increasing them substantially if some feel it necessary.
Again, Mr. Chairman, let me emphasize that we support the intent of
HR 2221 to provide patients with their contact lens prescriptions, and
to require doctors to respond to requests to verify those
prescriptions. Our sole concern with the legislation is that it should
also require sellers to provide doctors with basic patient information,
in an appropriate manner, so we may respond efficiently, and require
that prescriptions be positively verified by the doctor before lenses
are sold. We believe this is a balanced and reasonable approach that
addresses issues relating to both competition and health concerns.
Thank you for the opportunity to present testimony on this
important issue. We hope you find our input useful, and that we can
work with all interested parties to move this legislation forward in a
positive fashion.
Mr. Stearns. Thank you.
Mr. Hubbard, welcome.
STATEMENT OF ROBERT L. HUBBARD
Mr. Hubbard. Good afternoon. Thanks for having me. It's a
pleasure to be here.
I have been involved in this industry since March 1995.
There's been far too much to discuss. And I apologize if I
sometimes get into minutia or otherwise discuss items that
really aren't as important here. I would prefer to respond to
your questions. And otherwise I tried to provide written
testimony that gave an overview of the position of the States
and gave you some citations and the States would welcome any
request for additional information, elaborate on some of the
issues raised on that testimony and otherwise.
The summary of the written testimony is relatively
straightforward. State attorneys general wholeheartedly support
mandatory release of contact lens prescription. We have taken
this position publicly.
The first example of this is in comments that the States
gave to the FTC on the eyeglass rule at the time. And still the
rule applies only to eyeglasses and mandates the release of
prescriptions.
Back in 1997, we urged that it be extended to contact
lenses. We thought that the reason it hadn't originally been
extended to contact lenses had become outdated. And there have
been other developments.
We think now 6 years later, it is even more so that that
mandatory release is appropriate. Last year, 39 attorneys
general joined a letter in support of the H.R. 2663, which
supported mandatory release. And my testimony here today also
renews that commitment to the State attorneys general in
support for mandatory release of contact lens prescriptions.
The States have a lot of experience in this industry. In
addition to the competition advocacy that I have summarized
briefly, we have been engaged in a lot of litigation about this
precise problem trying to ensure that competition is the rule
of trade.
We have over time become quite skeptical of the health care
claims that are made about the kind of difficulties that
consumers face and the justifications for those restraints on
health care. We have asked for and never gotten the kind of
evidentiary support that we would find necessary to give those
health care claims credence. We alleged in our litigation that
such claims were deceptive. We were actively litigating that.
The settlement that we had in the disposable contact lens
litigation addressed those deception concerns. We required that
the AOA only make those health care claims when they were
supported by data.
I just reiterate that health care claims have been made
very since competition reared its head in this industry. And we
would have expected there to have been a manifestation of those
concerns and better documentation of them by now.
Finally, I note that I try to represent consumers. It's
part of my job. It's what an attorney general tries to do.
Consumers want their prescriptions. They want easy access to
non-eye care practitioners in order to buy contact lenses.
There is a significant economic and other benefit to consumers
being provided that. And, as I mentioned before, there's no
documented harm for consumers going to alternatives, instead of
their ECPs.
And I also note that the complaints that we hear about
almost always, if not always, come from the professionals, not
from the consumers themselves. It's not consumers that are
complaining that they got their lenses. It's always the
computer who is complaining that someone else sold the lenses.
Thank you very much.
[The prepared statement of Robert L. Hubbard follows:]
Prepared Statement of Robert L. Hubbard 1
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\1\ Director of Litigation, Antitrust Bureau, New York State
Department of Law. I also serve as Chair of Plaintiff States' Steering
Committee in the Disposable Contact Lens Antitrust Litigation, MDL 1030
(M.D. Fla.) and Chair of the Contact Lens Working Group of the NAAG
Antitrust Task Force.
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I am pleased to testify here today on H.R. 2221. The States
wholeheartedly support federal legislation that requires eye care
practitioners (ECPs) to release contact lens prescriptions, which H.R.
2221 does. Unlike most physicians, eye care practitioners sell what
they prescribe. Thus, individual ECPs derive substantial revenue from
the sale of replacement contact lenses and have an economic incentive
to withhold prescriptions from customers to prevent consumers from
shopping for replacement lenses elsewhere. In light of that incentive
and the power of ECPs over prescriptions, the bill helps give consumers
what they need to make their own choices about where to buy replacement
contact lenses.
in re disposable contact lens antitrust litigation
As part of enforcing antitrust and consumer protection laws, state
Attorneys General have an interest in maintaining open and competitive
markets and have long been focused on markets for the sale of contact
lenses. The most significant manifestation of that interest is In re
Disposable Contact Lens Antitrust Litigation, which involves 32 States
2 and a certified class in the Middle District of Florida,
Jacksonville Division, in front of United States District Judge Harvey
Schlesinger. In that litigation, plaintiffs alleged the high price and
limited availability of replacement contact lenses resulted from
illegal collusion among contact lens manufacturers (Johnson & Johnson
Vision Products, Inc. d/b/a Vistakon (J&J), Bausch & Lomb, Inc. (B&L),
and CIBA Vision Corp. (CIBA)), the American Optometric Association
(AOA), other groups of optometrists, and 13 individual optometrists.
Plaintiffs charged that the illegal agreement made it more costly and
difficult for consumers to buy replacement contact lenses from mail
order firms or pharmacies.
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\2\ Alabama, Alaska, Arizona, Arkansas, California, Connecticut,
Delaware, Florida, Idaho, Illinois, Iowa, Kansas, Louisiana, Maine,
Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nevada, New
Jersey, New York, North Carolina, North Dakota, Ohio, Oregon,
Pennsylvania, Texas, Utah, Virginia, West Virginia, and Wisconsin.
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In re Disposable Contact Lens Antitrust Litigation was a massive
undertaking. The investigation that led to the litigation began with a
complaint to Florida made by Monty Belote of the Florida Consumer
Action Network. The effort included over 200 depositions, 45 motions
for summary judgment, a docket sheet with over 1,400 entries, and five
weeks of trial before a jury before plaintiffs reached a settlement
with the last defendant. Even after the settlements, the states acted
to enforce the injunctive relief provisions of the settlements.
One major theme of plaintiffs' claims was that the illegal
agreement included making it difficult for consumers to get their
prescriptions. The Attorneys General gathered and offered evidence
showing systematic efforts by ECPs, their trade associations, and the
other defendants to prevent consumers from obtaining or using their
prescriptions. Aided by their trade association and contact lens
manufacturers, ECPs exchanged ideas and discussed in their trade
journals methods to discourage consumers from requesting their
prescriptions or to make the prescriptions they did release less
useful. They advised colleagues to refuse to give consumers
prescriptions or make consumers sign waivers that absolve the eye care
practitioner of ``liability'' in connection with the
prescription.3
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\3\ See, e.g., Koetting, I Want my Contact Lens RX, Optometric
Economics, 30-37 (February 1991); Kirkner, 10 Ways to Keep RXs from
Walking, Review of Optometry, 59-64 (Sept. 15, 1994) (article about a
roundtable of optometrists discussing how to keep patients from using
competitors); Snyder, Winning the War Against Mail Order Contact
Lenses, Optometry Today, Vol. No. 1 (1993). Koetting's article
describes the specific practices used, as simple refusal to give
prescriptions, falsely claiming that federal or state law prohibits
release of the prescription, writing prescriptions for brands that are
not widely available, or conditioning the prescription on signing by
consumers of a waiver or disclaimer.
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Ultimately plaintiffs settled with all of the defendants, and by
order dated November 1, 2001, the Court granted final approval of the
settlements.4 B&L agreed to sell its lenses to mail order
and pharmacies on a non-discriminatory basis, deposit $8 million into a
settlement fund, and offer a benefit package valued at $121 to all
consumers who purchased contact lenses since 1988.5 B&L
guaranteed it would distribute at least $9.5 million worth of benefits,
by agreeing to deposit the difference between what was distributed and
the $9.5 million into the settlement fund. J&J also agreed to sell its
lenses to alternatives like mail order and pharmacies on a non-
discriminatory basis. J&J agreed to deposit $25 million into a
settlement fund, offer a benefits package to contact lens wearers
valued at $100, guarantee distribution of $30 million in benefits, and
pay up to $5 million to former wearers of J&J lenses.6 AOA
agreed to pay $750,000, and the 13 individual defendants agreed to pay
$8,000 each. Additionally, AOA agreed to open access to replacement
lenses for consumers and to not restrict where consumers can obtain
contact lenses, including an agreement to refrain from opposing the
release of contact lens prescriptions.7 The Attorneys
General hope that consumers will enjoy significant benefits as a result
of these settlements.8
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\4\ State settlements are posted on the website of the State
Enforcement Committee of the Antitrust Section of the ABA, at http://
www.abanet.org/antitrust/committees/state-antitrust/home.html. The lens
settlements on the settlement portion of that website, within the 11th
Circuit portion of the list of settlements.
\5\ The B&L benefits package includes: (1) a single $50.00 rebate
per claimant on the purchase of four multipacks and an additional
$25.00 rebate per claimant on an additional purchase of four multipacks
of B&L disposable contact lenses; (2) a single $25.00 rebate per
claimant on an eye examination, provided that the claimant also
provides proof of purchase of Bausch & Lomb contact lenses; and (3)
coupons and product samples for B&L lens care products.
\6\ The J&J benefits package includes: (1) $50 off the purchase of
four six-packs of J&J disposable lenses; (2) $25 off the cost of an eye
exam; and (3) an additional $25 off a future purchase of four or more
lens six-packs.
\7\ The specific provision of the settlement between plaintiffs and
the AOA concerning prescription release provides: ``Consistent with
state law, the AOA will not object to the release of contact lens
prescriptions, except in the affirmative exercise of an optometrist's
own medical judgment related to the specific, identified and documented
health needs of a particular patient. The AOA will not develop,
disseminate, or urge the use of forms designed to limit either the
availability or utility of prescriptions. A form may contain reasonable
expiration dates, limitations on refills and other provisions which are
consistent with state law and good optometric practice.'' Settlement
5(a).
\8\ Early in the litigation, the States also settled with CIBA and
the other groups of optometrists.
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state competition advocacy in contact lens markets
Still, States have long recognized that litigation and the fruits
of litigation cannot address all of the competitive problems
characteristic of contact lens markets. Litigation did not and cannot
insure that every eye care practitioner releases prescriptions as a
matter of practice. Litigation cannot address the fundamental
structural problem in the market: that ECPs both prescribe and sell
contact lenses. Thus, to protect further the interests of consumers in
contact lens markets, states have also engaged in competition advocacy
in support of consumers who buy and use contact lenses.
States engaged in competition and consumer advocacy in vision care
markets generally when the States commented on the Federal Trade
Commission's ``Prescription Release Rule.'' That Rule was premised on
the finding that many consumers had difficulty comparison shopping for
eyeglasses because ECPs refused to release prescriptions. The Rule
requires an ECP to provide the patient at no extra cost a copy of the
patient's eyeglass prescription immediately after the eye examination
is complete.9 The Rule also: (1) prohibits the ECP from
conditioning the availability of an eye care examination on an
agreement to purchase ophthalmic goods; and (2) requires ECPs to
release eyeglass prescriptions to their patients regardless of whether
they request the prescription.10 The automatic release rule
alerts the consumer that the purchase of eyeglasses can be separate
from obtaining an eye exam. Contact lenses were excluded from this rule
because each pair required a new fitting.
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\9\ 16 CFR Part 456, (a)-(c), known as the ``Prescription Release
Rule,'' promulgated in 1978.
\10\ Id.
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For over twenty years that FTC Rule has mandated the release of
eyeglass prescriptions, and the Rule has served consumers well.
Mandating the release of eyeglass prescriptions has fostered a
competitive market for the retail sale of eyeglasses. Consumers have
enjoyed ever increasing competitive alternatives for purchasing their
eyeglasses. Consumers can have eyeglasses made in as little as one hour
and at a very low cost.
The States' comments on the FTC rule in 1997 both supported
continuation of the Rule and urged that the Rule be extended to contact
lens prescriptions.11 The States urged that mandatory
release of contact lens prescriptions would have similar results,
lowering consumer costs, as well as enhancing the healthier use of
these lenses by consumers. Since the FTC had promulgated the eyeglasses
Rule, the contact lens industry had developed in ways that justified
adding contact lens prescriptions to the Rule. When the Rule was
adopted, soft contact lenses were designed to be replaced annually,
coinciding with the period typically recommended for reexamination by
eye care practitioners. Beginning in the late 1980s, manufacturers
began to market and sell what are now known commonly as ``disposable''
or ``frequent replacement'' contact lenses, which are designed to be
replaced daily, weekly, or monthly. For these and other contact lenses,
manufacturers developed methods that greatly lessened the quality
control problems of late 1970s. Because contact lenses are now reliably
reproduced, replacement contact lenses are no longer individually
checked or individually adapted on the eye. Moreover, consumers have
increasingly chosen lenses that are replaced frequently over other
types of contact lenses, and selling replacement contact lenses has
developed into a significant market. The FTC retained the Rule, but did
not extend the rule to contact lenses.
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\11\ States Comments dated Sept. 2, 1997, of Attorneys General to
the Federal Trade Commission re 16 CFR Part 456 (Spectacle Prescription
Release Rule), available at the Legislative Advocacy portion of the
State Enforcement Website, supra note 3. The states submitting those
comments were Alaska, Arizona, Arkansas, California, Connecticut,
Delaware, Florida, Illinois, Iowa, Maryland, Michigan, Minnesota, New
York, Ohio, Pennsylvania, West Virginia, and Wisconsin.
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States have reiterated their position that mandatory prescription
release should apply to contact lenses. Thirty nine Attorneys General
acted to support of federal legislation last year (H.R. 2663) that
would have achieved that result.12
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\12\ Letters dated March 18, 2002 from State Attorneys General to
Representatives sponsoring H.R. 2663, the Contact Lens Prescription
Release Act of 2001, available at the Legislative Advocacy portion of
the State Enforcement Website, supra note 3. The thirty nine attorneys
general who joined that letter were from Alabama, Alaska, Arizona,
California, Colorado, Connecticut, Delaware, District of Columbia,
Florida, Hawaii, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland,
Massachusetts, Minnesota, Mississippi, Missouri, Nevada, New Hampshire,
New York, North Carolina, North Dakota, Northern Mariana Islands, Ohio,
Oregon, Puerto Rico, Rhode Island, South Carolina, Utah, Vermont,
Virginia, Virgin Islands, Washington, West Virginia, Wisconsin, and
Wyoming.
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Mandating the release of contact lens prescriptions would still
benefit consumers. Anti-consumer, anticompetitive practices have not
ended. Enforcement proceedings in the Disposable Contact Lens Antitrust
Litigation illustrated that many consumers still have significant
difficulties getting their contact lens prescriptions. Forms
implementing the practices discussed in the articles cited above
continue to be used. Although twenty-six states require release of
contact lens prescriptions, the specific requirements vary and anti-
consumer, anticompetitive practices persist concerning contact lens
prescriptions that are not permitted under the FTC eyeglass Rule.
Federal legislation would create a uniform national rule and extend
that rule to all of the nation's consumers.
The legislation would have a significant impact. Today, over 26
million consumers wear contact lenses. Alternative suppliers, like
pharmacies, mail order, buying clubs, department stores, and discount
merchandisers, give consumers a convenient and cost-effective method of
purchasing replacement contact lenses. The alternatives typically apply
a smaller markup than ECPs. These savings typically are passed on to
consumers in the form of lower costs and increased convenience.
Obtaining contact lenses from alternatives may also spare consumers the
cost of an extra unnecessary office visit to an eye care practitioner.
health care concerns have no evidentiary basis and do not justify
restraining consumer choice
The principal reason some ECPs advance for refusing to provide a
patient with his or her contact lens prescription, at least when public
policy makers are paying attention, is health care. By withholding
prescriptions, ECPs argue they are ensuring that the patient comes back
for eye care. If a consumer wants or needs replacement lenses, the ECP
theoretically could force the consumer to return to the ECP's office
and check the consumer's eye health. A receptionist or nurse could
probe the consumer's habits or the ECP could perform an examination.
This ``consumer health'' argument is based on the theory that, as a
``medical device,'' contact lenses require a professional's attention.
Yet, replacement lenses are not and need not be individually fit by an
eye care practitioner.
Contrary to this argument, mandatory prescription release would
probably benefit consumers' ocular health. As the cost and convenience
of buying replacement lenses improves, the safety of wearing contact
lenses, particularly disposable or frequent replacement lenses, should
also improve. If buying lenses is expensive and inconvenient, consumers
may stretch wearing schedules or engage in other conduct to extend the
life of their contact lenses. Wearing lenses for too long can harm
consumers if the lenses become dirty or carry bacteria or viruses that
would not develop if the lenses were replaced more frequently. Easier
access to, and lower prices for, replacement lenses encourage consumers
to use the lenses properly, thereby increasing patient safety.
In addition and based on their experience in the Disposable Contact
Lens Antitrust Litigation, States are skeptical of the health care
claims made by the opponents of prescription release. The litigation
addressed significant disputes about the relationship between ocular
health and the sale of replacement disposable contact lenses by
alternative channels of distribution. The AOA claimed that sales by
alternatives threatened ocular health, which plaintiffs alleged (and
the AOA denied) was deceptive.13 Plaintiffs alleged that a
1990 AOA presentation to the Food & Drug Administration was
deceptive.14 Plaintiffs also asserted that the AOA in 1992
decided not to survey the issue because the results might be that
alternative channels did not threaten, and may even improve, ocular
health, and that such a survey would have to be disclosed.15
In addition, Plaintiff States propounded various contention
interrogatories about studies on contact lenses and ocular health,
including one asking the AOA to ``Identify and describe all studies of
which you are aware that discuss any effect the dispensing of contact
lenses by alternative channels has on ocular health.'' In addition to
objecting to the interrogatory, ``the AOA state[d] it is aware of no
specific study as defined [in the objection].'' 16 Finally,
arguing that the testimony had no scientific basis, plaintiffs moved to
preclude expert testimony on whether alternative channels endangered
the health and safety of consumers.17 The AOA opposed that
motion, which was undecided when plaintiffs settled with the AOA.
---------------------------------------------------------------------------
\13\ Plaintiff States' Amended Complaint 49-55, Doc. No. 7 (97
CV 861); Florida Complaint 37, 41, Doc. No. 1 (94 CV 619);
Consolidated Class Complaint 37, 40, Doc. No. 23.
\14\ Florida's Consolidated Statement of Facts dated March 19,
1997, at 19-22, Doc. No. 270; Plaintiff States' Consolidated Statement
of Facts dated Nov. 12, 1999, at 57-60, Doc. No. 849.
\15\ Florida's Consolidated Statement of Facts dated March 19,
1997, at 29 n. 128, Doc. No. 270; Plaintiff States' Consolidated
Statement of Facts dated Nov. 12, 1999, at 83 n. 241, Doc. No. 849.
\16\ The AOA's Response to States' Third Discovery Requests to the
AOA dated February 8, 1999, at 32.
\17\ Plaintiffs' Motion In Limine to Preclude Expert Testimony of
Louis A. Wilson, A. Christopher Snyder, Gerald E. Lowther and Oliver D.
Schein, and Memorandum of Law dated Aug. 25, 1999, Doc. No. 774.
---------------------------------------------------------------------------
At plaintiffs' insistence and to settle those claims, the AOA
agreed to limit what it could say and do concerning those health care
assertions. Paragraph 5(h) of the settlement between plaintiffs and the
AOA provides:
The AOA shall not represent directly or indirectly that the
incidence or likelihood of eye health problems arising from the
use of replacement disposable contact lenses is affected by or
causally related to the channel of trade from which the buyer
obtains such lenses. Specifically, AOA shall not represent
directly or indirectly that increased eye health risk is
inherent in the distribution of replacement disposable contact
lenses by mail order, pharmacies, or drug stores. This
paragraph shall not prohibit the AOA from making such
representations where such representations are supported by
valid, clinical or scientific data.
Sales by ECP competitors do not give rise to any eye health
problems that the AOA can ``support by valid, clinical or scientific
data.'' 18 The States have repeatedly asked the AOA to
provide to the States any such data if the AOA becomes aware of such
data, but no such data has ever been provided.
---------------------------------------------------------------------------
\18\ Indeed, the AOA has not provided any evidence of consumer
harm, which is quite telling. Disposable contact lenses were introduced
and alternative channels began selling them in the late 1980s. The
States would expect any consumer harm flowing from the sale of
replacement contact lenses by alternative channels to have become
manifest by now if there were such evidence.
---------------------------------------------------------------------------
Moreover, this health care justification was properly rejected when
forwarded to justify the refusal to release eyeglass prescriptions, and
should now be rejected as a justification for refusing to release
contact lens prescriptions.
Moreover, a theoretical concern that a patient will not follow
health care directions without some coercion being applied does not
justify withholding information from consumers or eliminating
consumers' right to choose. The means of protecting the patient's
health are obvious and straightforward. The ECP can and should give
consumers full and complete advice about the need for proper and timely
examinations. The ECP can set a reasonable expiration date on
prescriptions. Product packaging and literature can fully inform
consumers about the advisability of periodic examinations. ECPs can
offer to set appointments in the future to encourage timely re-
examinations and can contact patients with reminders at appropriate
intervals. Yet, the consumer should be allowed to choose based on that
information, and should not be forced to do what an ECP wants based on
the practitioner's refusal to provide a prescription.
conclusion
When buyers are free to select their suppliers based on the
availability of reasonable prices, high quality service, and
convenience, everyone benefits. Legislation mandating the release of
contact lens prescriptions can move us closer to that goal. The states
firmly support mandatory contact lens prescription release.
Mr. Stearns. Thank you, gentlemen.
Ms. Gadhia, welcome.
STATEMENT OF AMI V. GADHIA
Ms. Gadhia. Good afternoon, Chairman Stearns and Ranking
Member Schakowsky and members of the subcommittee. Thank you
very much for providing me the opportunity to come here today.
My name is Ami Gadhia. I am assistant legislative counsel with
Consumers Union, the nonprofit publishers of Consumer Reports
magazine. I am pleased to be able to share our views on H.R.
2221.
Consumers Union supports H.R. 2221, the Fairness to Contact
Lens Consumers Act, because we believe that it will encourage
vigorous and fair competition in the contact lens market and
that it will ultimately result in lower prices and better
service for consumers. Consumers should be able to obtain their
contact lens prescription from their eye doctor so that they
may shop around and buy contact lenses from the vendor of their
choice in a marketplace that is allowed to be competitive.
According to the AOA, 32 States have passed such laws.
In 1995 and 1997, Consumers Union's Southwest Regional
Office conducted surveys of eye doctors in nine Texas cities to
determine whether consumers could get their prescription from
their eye doctor and use it to purchase lenses from the
dispenser of their choice.
The 1997 survey showed that 65 percent of eye doctors
surveyed refused to release a contact lens prescription to a
patient. These results indicated that in the majority of
situations, consumers were prohibited from purchasing contact
lenses from lower-priced vendors. In 1997, the Texas
legislature passed the Contact Lens Prescription Act, to which
H.R. 2221 is comparable.
The 2000 survey and the subsequent survey analysis in
January 2001 show that consumers have benefited from the Texas
Contact Lens Prescription Act. Eye doctors have accepted that
they must release a prescription to a patient. Consumers have
acquired the power to shop around for lower-priced contact
lens, and they have greater choices. In addition, eye doctors
have responded to this more competitive marketplace by lowering
prices and providing other services to patients, such as
conveniently mailing lenses directly to them and selling lenses
in 6-month bundles.
However, the 2000 survey also revealed certain areas of the
Texas law that when put into practice still make it difficult
for consumers to obtain their contact lens prescriptions. For
example, while eye doctors surveyed said that they would now
release prescriptions to patients, 57 percent said they would
not release a prescription unless patients came back for
follow-up visits, even if the patient had previously worn the
same contact lenses.
H.R. 2221 addresses the issue of eye doctors conditioning
the release of prescriptions on paid follow-up visits in
section 2(b)(2). It prohibits eye doctors from requiring
additional payment beyond the exam fee as a condition of
prescription release. However, if an eye doctor were to
condition the release of the prescription on an unpaid follow-
up visit, it is our opinion that it would be violating the
spirit, if not the letter, of the legislation.
H.R. 2221 also allows eye doctors to control the quality of
care of patients and to require medically necessary follow-up
visits. Section 2(a) of the bill states that the eye doctor
must release the prescription to the patient upon the
completion of a contact lens fitting. The bill further defines
contact lens fitting in section 8, to include medically
necessary follow-up examinations.
Section 3(3) also allows eye doctors to write a
prescription that expires in less than the otherwise required 1
year if the patient's medical condition so warrants. In
addition, patients must still rely on an eye doctor for exams
to renew their prescriptions, check their vision, and to
respond to any problems they are experiencing. And because
contact lens are worn directly on the eye, any discomfort would
lead those patients back to their eye doctors for help.
Eye doctors surveyed by Consumers Union also cited
protecting themselves from liability as a reason to refuse to
release prescriptions directly to patients. However, assuming
that an eye doctor provides a reasonable level of care, it
seems the doctors would have little to worry about in terms of
liability, especially for the actions of another that result
from the legal release of a prescription to the patient.
Concerns over the liability of eye doctors are perhaps
misplaced because the lenses that consumers receive from a
doctor's office are in most cases shrink-wrapped and packaged
in the same manner as those consumers would receive from
another vendor. The doctor-patient relationship is one based on
care and trust, and doctors should not be able to force a
consumer to continue seeing them by holding the consumer's lens
prescription hostage.
Our experience with the Contact Lens Prescription Act in
Texas indicates that the Fairness to Contact Lens Consumers Act
would most likely result in lower prices and better service for
consumers, and Consumers Union encourages its passage.
Thank you.
[The prepared statement of Ami V. Gadhia follows:]
Prepared Statement of Ami V. Gadhia, Assistant Legislative Counsel,
Consumers Union
summary
Consumers Union 1 supports H.R. 2221, the ``Fairness to
Contact Lens Consumers Act,'' because we believe that it will encourage
vigorous and fair competition in the contact lens market, and that it
will ultimately result in lower prices and better service for
consumers. Consumers should be able to obtain their contact lens
prescription from their eye doctor, so that they may shop around and
buy contact lenses from the vendor of their choice in a marketplace
that is allowed to be competitive. According to the American Optometric
Association, thirty-two states have passed such laws.2
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\1\ Consumers Union is a non-profit membership organization
chartered in 1936 under the laws of the state of New York to provide
consumers with information, education, and counsel about goods,
services, health, and personal finance, and to initiate and cooperate
with individual and group efforts to maintain and enhance the quality
of life for consumers. Consumers Union's income is solely derived from
the sale of Consumer Reports, its other publications, and from
noncommercial contributions, grants, and fees. In addition to reports
on Consumers Union's own product testing, Consumer Reports, with more
than 4 million paid circulation, regularly carries articles on health,
product safety, marketplace economics, and legislative, judicial, and
regulatory actions that affect consumer welfare. Consumers Union's
publications carry no advertising and receive no commercial support.
\2\ ``Passive Verfication: What's It Mean?'', Edited by Joseph P.
Shovlin, O.D, November 2002. Available at http://www.revoptom.com/
index.asp?page=2X716.htm. Downloaded September 6, 2003.
---------------------------------------------------------------------------
Two surveys conducted by Consumers Union's Southwest Regional
Office in 1995 and 1997 indicated that in the majority of situations,
consumers were unable to obtain their contact lens prescription from
their eye doctor and that as a result, they were prohibited from
purchasing contact lenses from lower-priced vendors. In 1997, the Texas
Legislature passed the Contact Lens Prescription Act, to which H.R.
2221 is comparable.
An October 2000 follow-up survey and subsequent survey analysis in
January 2001 show that consumers have benefited from the Texas Contact
Lens Prescription Act. Eye doctors have accepted that they must release
a prescription to a patient 3, consumers have acquired the
power to shop around for lower-priced contact lens, and they have
greater choice. In addition, eye doctors have responded to this more
competitive marketplace by lowering prices and providing other services
to patients.
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\3\ The Texas Contact Lens Prescription Act states that an eye
doctor must provide the prescription at the time he or she ``determines
the parameters of the prescription.'' (Texas Occupations Code, Chapter
353, Contact Lens Prescription Act, Article 353.156(b)). H.R. 2221
states that an eye doctor must release the prescription ``upon
completion of a contact lens fitting.'' (H.R. 2221 Section 2(a)).
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The results of Consumers Union's survey in 2000 also demonstrated
the possible cost savings for consumers because prices can vary
dramatically. The cost of an eye exam ranged from $55 to $180. Prices
for replacement boxes of contact lenses ranged from $18 to $42 for the
same brand and type. Since buying lenses from the eye doctor may cost
more, consumers benefit from immediate access to their prescriptions.
Although the follow-up survey also showed that some doctors were
refusing to give patients their contact lens prescriptions by
exploiting loopholes in the Texas law, the overall result of the law
was that most eye doctors comply with the law by giving patients their
contact lens prescription, and that consumers are reaping the benefits
in the form of lower prices for contact lenses.
consumers union's work in texas
In 1995, Consumers Union conducted a survey of optometrists and
ophthalmologists (``eye doctors'') in nine Texas cities 4 to
determine whether consumers could get their prescription from their eye
doctor and use it to purchase lenses from the dispenser of their
choice. At that time, Consumers Union found that most eye doctors would
not release the prescription to the patient, forcing consumers to
purchase their lenses from the eye doctor who provided the exam.
Consumes Union also determined from their 1995 survey that the price of
such lenses varied considerably, and the practice of withholding the
prescription limited the consumer's ability to shop for the best price.
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\4\ Austin, Corpus Christi, Dallas, El Paso, Houston, Laredo,
Midland/Odessa, San Antonio, and Tyler.
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In 1997, just before the introduction of the Contact Lens
Prescription Act in the Texas State Legislature, Consumers Union again
surveyed optometrists in the same nine Texas cities. Like the prior
survey, this one was designed to recreate the actual experience of a
consumer shopping for the best buy in contact lens care. From area
phone books in nine cities, Consumers Union compiled a list of
optometrists and eye care discount centers and made 71
contacts.5
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\5\ Consumers Union staff inquired as to whether or not each office
would fill a contact prescription that was over six months old without
first examining the patient's eyes; they asked how much a contact lens
eye exam would cost the consumer if he or she wanted to be sure that
their prescription had not changed; they asked if the optometrist would
give us our contact lens prescription; and they requested prices of
replacement lenses. To be consistent, the questions focused solely on
clear daily wear soft contact lenses.
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Of the 71 inquiries to Texas Optometrists, only 24 responded that
they would release a contact lens prescription to a patient. Forty-six
practitioners, or 65 percent, refused to release the prescription to a
patient. In addition to holding the prescription, some eye doctors also
resisted competition by creating package deals that tied the consumer
to them in the future. A typical package deal included the eye exam, a
set of lenses, a follow-up visit, and a cleaning kit.
In addition, consumers were often unaware that their eye doctor
would not release the contact lens prescription until after they
purchased a package deal. They were therefore forced into returning to
that eye doctor for their replacement contacts unless they wanted to
pay for another exam.
Finally, the 1997 survey found that when a patient returned to the
optometrist for replacement lenses, replacement costs varied
widely.6 A package deal that initially appeared to be a
bargain may actually have cost consumers more in the long run. A
patient could probably save money by paying for the eye exam only and
having the prescription filled elsewhere.
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\6\ In 1997, the replacement costs ranged from $40 to $140 a pair.
Consumers Union does not have updated dollar figures for this survey
result.
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the texas contact lens prescription law and h.r. 2221
In 1997, the Texas Legislature passed the Contact Lens Prescription
Act. This act requires eye doctors to give a patient their contact lens
prescription upon request, at the time that the eye doctor ``determines
the parameters of the prescription.'' 7 The Texas law states
that prescriptions expire after one year. Under the Texas law and the
opinion of the state Optometry Board, eye doctors were also only
required to give out a prescription once, so consumers who lost their
prescriptions were left with no alternative but to purchase lenses from
the prescribing doctor.
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\7\ Texas Occupations Code, Chapter 353, Contact Lens Prescription
Act, Article 353.156(b).
---------------------------------------------------------------------------
H.R. 2221 is comparable to the Texas law in that it requires eye
doctors to release prescriptions for contact lenses to consumers. The
Texas law requires the patient to request the prescription, while H.R.
2221 improves on this provision by requiring the eye doctor to give the
prescription to all patients.
H.R. 2221 is also similar to the Texas law in that it requires
prescriptions to be for at least one year unless medically indicated to
expire in a shorter time period. This ensures that eye doctors do not
place arbitrary expiration dates on the prescription to force the
patient to return to the office for replacement lenses.
Another issue that arises when comparing the Texas law and H.R.
2221 is that of active versus passive verification by an eye doctor to
a third party of a consumer's prescription. The Texas law was silent on
the issue of verification, and H.R. 2221 requires the Federal Trade
Commission to study this issue.
Consumers Union believes that as long as a vendor has a reason to
believe that the prescription is still valid, i.e., as long as there is
evidence of some kind (such as a fax of the prescription), then passive
filling should be appropriate. A reasonable period of time for
verification might be two days, but this is a debate best worked out
between the eye doctors and vendors. Our goal is to ensure that
consumers with a valid prescription can get it filled by whomever they
choose, and to ensure that the system accommodates that choice.
the texas law in practice
In order to determine if eye doctors were complying with the new
Texas statute, in October 2000 Consumers Union conducted a follow-up to
its two prior surveys. Consumers Union reviewed 44 complaints with the
Texas Optometry Board 8, and surveyed optometrists in the
same nine cities as in the prior surveys.
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\8\ While the complaint information was largely anecdotal, the
files revealed interesting details about the process some consumers had
to go through to get their contact lens prescriptions.
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A January 2001 analysis of the October 2000 follow-up survey shows
that consumers have benefited from the Texas Contact Lens Prescription
Act. Eye doctors have accepted that they must release a prescription to
a patient 9, consumers have acquired the power to shop
around for lower-priced contact lens, and they have greater choice. In
addition, eye doctors have responded to this more competitive
marketplace by lowering prices and providing other services to
patients, such as conveniently mailing lenses directly to them (and as
is done by third-party contact lens vendors) and selling lenses in 6-
month bundles.
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\9\ The Texas Contact Lens Prescription Act states that an eye
doctor must provide the prescription at the time he or she ``determines
the parameters of the prescription.'' (Texas Occupations Code, Chapter
353, Contact Lens Prescription Act, Article 353.156(b)). H.R. 2221
states that an eye doctor must release the prescription ``upon
completion of a contact lens fitting.'' (H.R. 2221 Section 2(a)).
---------------------------------------------------------------------------
However, the survey also revealed certain areas of the Texas law
that, when put into practice, show ways that the Texas law can be
improved upon. For example, while eye doctors surveyed said they would
now release prescriptions to patients, most required follow-up visits
before releasing the prescription, even for long-time contact lens
wearers with no medical problems. Fifty-seven percent of optometrists
would not release a prescription unless patients came back for a
follow-up visit, even if the patient had previously worn the same
contact lenses.
The review of the complaints filed with the Texas Optometry Board
provided anecdotal evidence of a number of other barriers to
competition in the contact lens market. About one third of contact lens
complaints to the Board reviewed by Consumers Union involved follow-up
cases where doctors refused to release prescriptions because patients
did not come back for a follow up exam.
Under H.R. 2221, an eye doctor conditioning the release of a
patient's prescription on a paid follow-up visit would be violating
Section 2(b)(2) of the legislation. But even if the eye doctor were
conditioning release of the prescription on a free follow-up visit, he
or she would at the very least be violating the spirit of the
legislation. While Texas legislation in 2001 failed to correct this
problem, the Board of Optometry issued a rule later that year requiring
that follow-up exams must be medically indicated and must occur within
30 days of the original fitting exam.
What is more, many patients who have worn contact lenses before do
not need to return for a follow-up visit to finalize their
prescription, and eye doctors have a clear financial interest in
bringing consumers back into their store. A long-time contact lens
wearer, and particularly a typical wearer of two-week disposable soft
contact who likes his or her lenses, can probably be examined and
``fitted'' at a single visit for replacement lenses, according to the
Contact Lens Clinic at the University of Washington.10
---------------------------------------------------------------------------
\10\ Contact Lens Clinic at the University of Washington, http://
www.depts.washington.edu/ophthweb/contacts.html. Downloaded September
7, 2003.
---------------------------------------------------------------------------
The 2000 Consumers Union survey also found evidence of eye doctors
charging customers for a ``service agreement'' covering follow-up
visits that tied the patient to that practitioner's office. Some eye
doctors also refused to release the prescription if the patient's
insurance company was late paying a claim. We see no reason why the
consumer should be prevented from shopping around for the lowest price
for contact lenses because of a dispute between the insurance company
and the provider.
quality of care and liability concerns
The majority of optometrists surveyed by Consumers Union in 1997
cited two particular reasons for refusing to release prescriptions
directly to all patients: to control the quality of care and to protect
themselves from liability. Regarding the first concern, to ensure that
a patient continues to receive quality eye care, most of those surveyed
said that a contact lens is a ``medical device'' and therefore requires
a professional's care. They say it is in the patient's own best
interest that they do not release the prescription.
However, patients must still rely on an eye doctor for exams to
renew their prescriptions, check their vision, and to respond to any
problems they are experiencing. And, because contacts are worn directly
on the eye, any discomfort will lead most patients back to their eye
doctor for help.
In the case of replacement lenses, the primary protection of
product quality rests with the manufacturer, since most eye doctors
sell replacement lenses in pre-packaged containers, as do other
dispensers.11 Furthermore, regardless of the source,
patients who get these pre-packaged lenses can and should always check
the expiration date on the package.
---------------------------------------------------------------------------
\11\ If a consumer were given replacement lenses that had a broken
seal, we would advise them to return the lenses for a different box,
unless the patient has watched the optometrist remove them from the
box. In reality, the eye doctor is not handing over the box of
replacements; his employees are doing so.
---------------------------------------------------------------------------
Regarding liability, many of the offices contacted in Consumers
Union's 1997 survey said that the practitioner would not release the
contact lens prescription to the patient for dispensing elsewhere
because the prescribing eye doctor would still be held liable if the
prescription were filled incorrectly by a different vendor. However,
assuming that an eye doctor provides a reasonable level of care, it
seems that doctors would have little to worry about in terms of
liability, especially for the actions of another (e.g., either the
third-party vendor or the lens manufacturer) that result from the legal
release of a prescription to the patient.
conclusion
Contact lenses are a fact of daily life for millions of consumers.
The increasing popularity of daily-wear, 2-week, and 30-day disposable
lenses means that the number of consumers seeking the most affordable
contact lenses will only grow. Consumers Union supports H.R. 2221
because it will give consumers the means to shop around to find contact
lenses at the best price.
Concerns over the liability of eye doctors are perhaps misplaced,
because the lenses that consumers receive from a doctor's office are in
most cases shrink-wrapped and packaged in the same manner as those
consumers would receiver from another vendor. The doctor-patient
relationship is one based on care and trust, and doctors should not
force a consumer to continue seeing them by holding the consumer's lens
prescription hostage. Our experience with the Contact Lens Prescription
Act in Texas indicates that the ``Fairness to Contact Lens Consumers
Act'' will most likely result in lower prices and better service for
consumers, and Consumers Union urges its passage.
______
Executive Summary
In order to determine if Texas eye doctors are releasing contact
lens prescriptions in compliance with the Contact Lens Prescription
Act, Consumers Union recently conducted a survey in nine cities:
Austin, Corpus Christi, Dallas, El Paso, Houston, Laredo, Midland/
Odessa, San Antonio, and Tyler.
The survey showed that eye doctors are generally releasing
prescriptions; however, many are requiring patients to attend follow-up
visits and/or buy a first supply of lenses from them. These practices,
and others currently allowed under the statute, ensure that consumers
face an uphill battle if they want to shop around for the best deal in
contact lenses.
Most eye doctors now release prescriptions, although eye doctors have
created a number of frustrating (but currently legal) barriers
to the reasonable and fair use of the prescription:
1. 57% of optometrists would not release a prescription unless
patients came back for a follow-up visit, even if the
patient had previously worn the same contact lenses. About
a third of contact lens complaints to the Texas Optometry
Board reviewed by Consumers Union involved follow-up cases
where doctors refused to release prescriptions because
patients did not come back for a follow-up exam.
2. The prohibition against faxed prescriptions prevents ready
transfer to internet or 1-800 type distributors;
3. Some eye doctors write prescriptions for the minimum period
allowed under the law (one year) regardless of the
individual's history with the lenses, and refuse
prescription release if the customer has already purchased
one year's worth of lenses;
4. Some eye doctors charge customers for a ``service agreement''
covering follow-up visits that ties the patient to that
practitioner's office;
5. Eye doctors are only required to give out a prescription once,
according to the Optometry Board, leaving consumers who
lose their prescriptions with no alternative but to
purchase lenses from the prescribing eye doctor; and
6. Eye doctors may refuse to release the prescription if insurance
companies are late paying a claim.
Our survey found only two eye doctors who would not release a
prescription at all. Four additional optometrists would not
release prescriptions unless patients first bought an initial
(three or six month) supply of contact lenses from them. Both
of these practices are in direct violation of the Texas Contact
Lens Prescription Act.
Shopping for lenses and services saves money. The cost of an eye exam
ranged from $55 to $180. Prices for replacement boxes of
contact lenses ranged from $18 to $42 for the same brand and
type. Since buying lenses from the eye doctor may cost more,
consumers benefit from immediate access to their prescriptions.
When a person chooses an eye doctor, cost should not be the
only factor, of course. Finding a doctor you can trust to
provide quality care at a fair price may take time and
research, but it pays off in the long run.
introduction: the contact lens prescription act
In March 1997, the Southwest Regional Office of Consumers Union
released a survey of optometrists and ophthalmologists (``eye
doctors'') from nine Texas cities to see if consumers could obtain
their contact lens prescriptions from their eye doctor and use them to
buy lenses from the dispenser of their choice. At that time, Consumers
Union found that most eye doctors would not release a contact lens
prescription directly to patients. We also found that since the cost of
contacts varied widely, eye doctors' refusals to release prescriptions
limited a consumer's ability to find the best price.
In June 1997, the 75th Texas Legislature passed House Bill 196,
``The Contact Lens Prescription Act'' (recodified in 1999 as Chapter
353 of the Occupations Code). This Act made the release of contact lens
prescriptions mandatory, but it also contained a number of loopholes
that enabled eye doctors to manipulate the law to protect their contact
lens sales.
If a patient requests a contact lens prescription during the
initial or annual exam, the eye doctor must provide the prescription at
the time he or she ``determines the parameters of the prescription.''
\1\ The legislation gave eye doctors the flexibility to determine a
contact lens wearer's needs based on the ocular health of individual
patients. For example, a new user might need to try new lenses for a
week and return for a follow-up visit to be sure the new lenses worked
properly. An existing wearer making no changes in the lens type might
need only an exam and verification that the current lenses are
comfortable.
---------------------------------------------------------------------------
\1\ Occupations Code, Chapter 353, Contact Lens Prescription Act,
Article 353.156(b).
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Some eye doctors, with the blessing of the Texas Optometry Board,
have instead used the flexibility granted by statute to create
procedures that apply to every patient-in particular the follow-up
visit requirement. Eye doctors who require a second visit can refuse to
provide the contact lens prescription to those who did not return for
the follow-up.\2\
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\2\ Texas Administrative Code, Title 22, Part 14, Chapter 279, Rule
279.7(b)(1). Also ibid.
---------------------------------------------------------------------------
Under the statute, the patient can request the prescription at any
time while it is valid (prescriptions cannot be written for less than a
year) \3\ but if the prescription has already been filled by the eye
doctor, the eye doctor can refuse to provide it.\4\ Although the
statute specifically requires eye doctors to extend the prescription
time upon request of a patient, it does not specify that this extension
applies to patients who have already purchased a full one year supply
of lenses.\5\ Because the prescription specifies the number of lenses,
people losing or tearing a lens cannot replace it without another exam.
---------------------------------------------------------------------------
\3\ Occupations Code, Chapter 353, Contact Lens Prescription Act,
Article 353.153 and 353.157(B)(5).
\4\ Occupations Code, Chapter 353, Contact Lens Prescription Act,
Article 353.103(d) and 353.152(6).
\5\ Occupations Code, Chapter 353, Contact Lens Prescription Act,
Article 353.155(b) and Optometry Board interpretations as expressed to
consumers in responses to complaints, TOB complaint # 00065, March 1,
2000, and TOB complaint #00009, October 5, 1999.
---------------------------------------------------------------------------
A ``valid'' prescription must be an original and picked up in
person or mailed. A faxed prescription is not ``valid.'' \6\ Further
the eye doctor is only required to provide the prescription once,
according to Optometry Board interpretation.\7\ The statute actually
says that an eye doctor must provide the prescription ``at any time
during which the prescription is valid,'' and does not limit the number
of times eye doctors must give out an original prescription.\8\
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\6\ Occupations Code, Chapter 353, Contact Lens Prescription Act,
Article 353.101 and 353.152(5).
\7\ Texas Optometry Board complaint, TOB#00047, December 2, 1999,
letter to complainant, 1/3/2000.
\8\ Occupations Code, Chapter 353, Contact Lens Prescription Act,
Article 353.156(c).
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Eye doctors can refuse to release prescriptions for medical
reasons, if financial obligations have not been met (including pending
insurance claims), or if the request is made after the first
anniversary of the patient's last eye exam. If the doctor refuses to
release the prescription he or she must tell the patient the reason and
document it in the patient's record.\9\
---------------------------------------------------------------------------
\9\ Occupations Code, Chapter 353, Contact Lens Prescription Act,
Article 353.157.
---------------------------------------------------------------------------
Eye doctors cannot charge a fee in addition to the examination and
fitting fees as a condition for releasing the prescription. Eye doctors
cannot make the release of a contact lens prescription conditional on a
patient's agreement to buy contact lenses from the eye doctor.\10\
However, Optometry Board action on consumer complaints indicates that
eye doctors may be able to refuse patient requests for their
prescriptions if patients do not agree to attend (and sometimes pay
for) ongoing follow-up care. Eye practitioners who place unnecessary
burdens on their customers in the name of ``ocular health'' violate the
spirit, if not the letter, of the Contact Lens Prescription Act.
---------------------------------------------------------------------------
\10\ Occupations Code, Chapter 353, Contact Lens Prescription Act,
Article 353.158.
---------------------------------------------------------------------------
survey 2000
In order to determine if eye doctors are complying with the new
statute, Consumers Union conducted a new survey in October 2000 and
reviewed 44 complaints filed with the Optometry Board related to
contact lenses. While the complaint information is largely anecdotal,
the files reveal interesting details about the process some people have
to go through to get their contact lens prescription.
Consumers Union again surveyed optometrists in the same nine
cities: Austin, Corpus Christi, Dallas, El Paso, Houston, Laredo,
Midland/Odessa, San Antonio and Tyler. This survey found that while eye
doctors now say they will release prescriptions to patients, most
require a follow-up visit before releasing the prescription, even for
long time contact lens wearers with no medical problems. In addition,
complaints filed with the Optometry Board provide anecdotal evidence of
a number of other barriers to competition in the contact lens market.
findings
Two of 83 optometrists surveyed would not release a prescription at
all, while four more would not release it unless patients first
agreed to buy an initial supply of contact lenses from them.
These are clear violations of the Contact Lens Prescription
Act.
57% of optometrists surveyed would not release a prescription unless
patients came back for a follow-up visit, even if the patient
had previously worn the same type of contact lenses. About a
third of the contact lens complaints to the Texas Optometry
Board reviewed by Consumers Union involved follow-up cases
where doctors refused to release the prescription because
patients did not come back for their follow-up exam.
Shopping for lenses and services saves money. The cost of an eye exam
ranged from $55-$180. Prices for replacement contact lenses
ranged from $18 to $42 for the same brand and type. Since
buying lenses from the eye doctor may cost more, consumers
benefit from immediate access to their prescriptions.
survey method
We conducted the survey in October 2000 by telephone in nine Texas
cities: Austin, Corpus Christi, Dallas, El Paso, Laredo, Midland/
Odessa, San Antonio, and Tyler. We compiled a list of 83 optometrists
and eye care discount centers from area telephone books. Posing as
long-time contact lens wearers, we asked questions designed to find the
best buy in contact lens care. We asked what a contact lens exam and
replacement lenses would cost. We also asked if our prescription could
be released and if the procedure regarding initial exams and follow-ups
could be explained to us.
To obtain consistent data, our questions focused solely on frequent
replacement soft lenses because they are the most commonly used
contacts (see page 7 for a description of common types of contact
lenses). Of the 34 million contact lens wearers in the United States,
85% wear soft contact lenses.\11\
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\11\ Contact Lens Council, Landover, Md.,
www.contactlenscouncil.org, download 11/1/00, based on 1999 data.
---------------------------------------------------------------------------
prescription release
Of the 83 respondents, most said they would release the contact
lens prescription. Only two indicated that they would not. This is a
significant improvement since the passage of the new statute.
But we found four additional offices that will not release contact
lens prescriptions unless the patient buys the first supply (generally
two boxes for use over three months) of lenses from them. By refusing
to release contact lens prescriptions without strings attached, these
eye doctors are not complying with the law. The Texas Contact Lens
Prescription Act forbids eye doctors from refusing to release contact
lens prescriptions or conditioning the release of a contact lens
prescription on the patient's agreement to buy contact lenses or other
ophthalmic goods.\12\
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\12\ Occupations Code, Chapter 353, Contact Lens Prescription Act,
Article 353.156 and 353.158(2).
---------------------------------------------------------------------------
For consumers shopping for contacts and exam services, the terms
that eye care offices use to describe what is required can be
misleading. In our survey, many eye care offices said we would need to
buy a ``first set of lenses,'' or ``first lenses,'' or a ``first
supply'' or ``pair of lenses'' from them. In some cases this meant only
a ``trial pair'' or two contact lenses (one for each eye). State law
allows a charge for the lenses consumers take away in their eyes. To
check the accuracy of our understanding, we made a second round of
phone calls to all the doctors who required the purchase of lenses and
determined that in four cases these general terms actually meant that
the consumer must purchase boxes of lenses (a three or six month
supply)--a clear violation of the statute.
Increasing shoppers' confusion, most eye care offices we called
initially quoted us a package price that included the cost of a three
month, a six month, or even a year supply of lenses. In most cases we
had to specifically ask the office to give us only the cost of the exam
and fitting (and any follow-up charge where mandatory), and then ask
for the cost of lenses so we could compare these costs to other lens
dispensers.
Despite the confusion, shopping still makes sense. Consumers who
call for the best price can save $40 on each three month supply of
lenses (two boxes), and as much as $90 on the cost of an exam. Exam
costs ranged from $55 to $180.\13\ While Tyler had a $30 difference in
the highest and lowest cost of their exams, Austin had an $89
difference. When a person chooses an eye doctor, cost should not be the
only factor, of course. Finding a doctor you can trust to provide
quality care at a fair price may take time and research, but it pays
off in the long run.
---------------------------------------------------------------------------
\13\ Many of the optometrists surveyed had two different prices: a
price for exams and a package price. Packages include the exam, a set
of lenses, a follow-up visit, and a cleaning kit.
---------------------------------------------------------------------------
A consumer who can take a prescription anywhere to be filled may
save significantly. When we shopped for a box of Acuvue soft lenses
(each box has six lenses, or a three month supply) we found prices
ranged from $18 to $42 per box, although prices within some cities
tended to be closer. On average, optometrists in most cities charged
$20 to $25 a box, although in Houston and El Paso the difference in the
highest and lowest costs for boxes of Acuvue soft lenses was actually
$20-with some offices charging twice as much as others.
Some optometrists quoted their prices in terms of six months or a
year supply. In some cases-but not all-consumers can save money by
buying in bulk. It can also pay to buy online. For example, on the day
we checked, 1-800Contacts charged $19.95 per box of Acuvues, and the
shipping was free for online orders. Lens Express also charges $19.95
per box of Acuvues; however, the price does not include a $5.95
shipping charge.\14\
---------------------------------------------------------------------------
\14\ https://order.1800contacts.com/, http://www.lensexp.com
---------------------------------------------------------------------------
Consumers in Texas face barriers to shopping on line or at discount
centers. According to the Optometry Board, eye doctors are only
required to give an original prescription to a patient once.\15\ And
faxes or photocopies of the original cannot be filled. Therefore
consumers who lose their original prescription must purchase their
lenses from the examining eye doctor thereafter.
---------------------------------------------------------------------------
\15\ Texas Optometry Board complaint, TOB#00047, December 2, 1999.
---------------------------------------------------------------------------
And consumers who buy online may be told by their eye doctor that
they must come in person, pick up an original prescription and mail it
to the online service.\16\ If consumers want to choose a different
online service with a better deal a few months later, the eye doctor
can refuse to provide a second original prescription. Finally, each
prescription is written for a specific number of lenses. If a consumer
tears a lens or loses a box, then the prescription can ``run out'' long
before the year is up, and the eye doctor can require a new exam before
writing it out again.
---------------------------------------------------------------------------
\16\ Interview with Joe Zeidner and Jonathan Coon, 1800-contacts,
December 11, 2000, and eye doctor written responses to Request for
Release of Contact Lens Prescription.
---------------------------------------------------------------------------
the follow-up visit
In our survey we found that 57% of eye doctors require follow-up
exams before releasing a prescription, but 43% do not. The Texas
Contact Lens Prescription Act does not require patients to return for a
follow-up visit in order to take away their prescription. However,
Board Rule 279.7 (issued by the Optometry Board before passage of the
Act and still in place) requires every patient to have at least one
follow-up visit.\17\ Almost half of the eye doctors surveyed are in
violation of this rule, since they allow patients with no medical
problems to take away their prescriptions after a single visit. These
doctors are in compliance with the spirit of the statute, however.
---------------------------------------------------------------------------
\17\ Texas Administrative Code, Board interpretation number seven,
Rule 279.7
---------------------------------------------------------------------------
The requirement that lens wearers return for a follow-up visit in
order to get their prescription filled elsewhere creates an unnecessary
barrier to competition and is clearly not aimed at the specific medical
needs of individual patients. According to a recent FDA survey of eye
care practitioners, the majority recommend annual visits for contact
lens wearers.\18\
---------------------------------------------------------------------------
\18\ An FDA Survey of U.S. Contact Lens Wearers, Contact Lens
Spectrum, July 1997. Available on the FDA web site at www.fda.gov.
---------------------------------------------------------------------------
Among wearers who actually complained to the Optometry Board about
their problems getting a prescription released, the follow-up visit
restriction was one of the most commonly cited barriers. Consumers
Union reviewed 44 contact lens complaints from the Texas Optometry
Board. About a third involved follow-up, where doctors refused to
release the prescription because patients did not come back for one of
the doctor's recommended follow-up visits. Some of these were long time
wearers of contact lenses.\19\
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\19\ Texas Optometry Board complaints, TOB #s: 99098, 00008, 99058,
98137, 99051, 99116, 00100, 99080, 00113, 99059, Vicki Amos 1999,
Michael Morrow 1999, Deborah Young 1998, Maggie Saucedo 1999, Patricia
Novoa 1999.
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Nineteen-year old Ms. B. of Longview visited Childress Vision
Clinic for a contact lens exam on November 24, 1998. She had already
worn contacts for five years. According to the Childress Clinic, Ms. B.
attended a follow-up visit on December 2 to fit the lenses and ``allow
the lenses to conform to their ocular environment.'' She sat in the
office for about an hour with the lenses in her eyes. At that time the
clinic sold her a ``continuing service agreement'' (costing $100 for a
year) and told her that she would have to return for ``contact lens
progress evaluations.'' She returned again on December 30 to pick up
her lenses, and the eye doctor scheduled her for yet another follow-up
exam January 5. She did not show up for this visit.
In May, Ms. B called the Childress Clinic because she had ripped
her lens. She did not like the price quoted for replacements and asked
for her prescription. According to her mother, the clinic refused and
the family could not get a satisfactory explanation. They asked their
insurance carrier to intervene. ``Our insurance company said Dr.
Childress said he couldn't give the prescription because her exam
wasn't complete,'' Ms. B's mother wrote to the Optometry Board. Her
daughter had in fact visited the office three times in the course of a
month, and had apparently experienced no trouble with the prescription
thereafter. The ``service agreement'' she purchased required her to
return for an exam every six months, in addition to the series of
initial exams.
When her mother complained to the Optometry Board, the eye doctor
agreed to a fee refund but did not agree to provide a copy of the
prescription. The Board wrote to the family that ``the complaint is the
type of business dispute which is not within the Board's
jurisdiction,'' and further noted that the eye doctor had offered her a
fee refund. The Optometry Board closed its file.\20\
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\20\ Texas Optometry Board complaint, TOB#99098, June 25, 1999.
---------------------------------------------------------------------------
This ``service contract'' was not a singular incident. Some eye
doctors require a patient to sign up for a long-term contract of
ongoing care, and if they are not available for that ongoing care, they
cannot have their prescription.
Amy Greer, a medical student in Lubbock, went to an eye doctor in
her home town of North Richland Hills for a contact lens exam and
prescription in the summer of 1999. At that time, the office charged
her $120 in exam fees, including a $66 fee for ``professional fees
which include any contact lens related visits for a year.'' She did not
purchase contact lenses, but a few weeks later she asked for her
prescription. At that point, the eye doctor told her that since she
would not be available for ``ongoing follow-up care'' he would refund
her fee of $66 and forward her exam records to a doctor in the Lubbock
area, but he did not agree to give her the prescription.
``I am professionally liable for patients for which I write contact
lens Rx's,'' he told the Optometry Board. ``We do routinely release
contact lens Rx's as long as the patient realizes that we are still the
prescribing doctor and responsible for follow-up care services. It is
hardly fair to ask a doctor to be responsible for a patient for an
entire year and then not allow the doctor access to that patient to
insure that all is physiologically well as per FDA guidelines.''
According to this doctor, patients should return for follow-up
visits at least every three months for extended wear contacts, and
every six months for daily wear contacts. According to the final letter
from the Optometry Board to Ms. Greer, the doctor is not required to
release a contact lens prescription if no examination ``and/or follow-
up'' is provided to the patient. The Board recommended that she seek
out an eye doctor in Lubbock, which she ultimately did, having to pay
her exam fee all over again.\21\
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\21\ Texas Optometry Board complaint, TOB#99116, August 24, 1999
and telephone interview with Amy Greer, December 13, 2000.
---------------------------------------------------------------------------
How much care is really needed for regular contact lens consumers
who are comfortable with their contacts?
Most medical doctors do not sell pharmaceuticals or medical devices
(the Food and Drug Administration categorizes contact lenses as a
medical device). Physician investment in labs or testing facilities to
which they refer patients is restricted to prevent a conflict of
interest. The law places physicians at an arm's length from companies
that profit on the tests, medical devices and drugs they prescribe
because profit on these items might affect their medical judgement. In
particular it might lead to overprescribing and unnecessary care. But
eye care practitioners may sell the items they prescribe and make a
profit. In this case, the financial interest in bringing people back to
the office, where they will very likely purchase their lenses, may lead
some eye doctors to overstate the medical need for follow-up visits.
Eye doctors who place unnecessary burdens on all of their customers in
the name of ``ocular health'' violate the intent of the Contact Lens
Prescription Act, and illustrate the conflict of interest that exists
when one business both prescribes and sells a medical product.
the ``fitting''
Eye doctors say follow-up visits are required to complete the
``fitting,'' for which they typically charge a fitting fee. But what
exactly is the ``fitting,'' and does it require multiple visits to the
eye doctor?
In general, the eye exam measures the power of the prescription,
while the fitting measures the shape of the front surface of the eye.
The eye doctor typically uses an instrument called a keratometer to
determine the proper curve and size for the contact lens. The eye
doctor may also measure the dryness of the surface of the eye, making
sure that once placed on the eye the lens fits and moves properly.
For most consumers there is no bright line between the end of the
``exam'' and the beginning of the ``fitting'' except that they believe
both are generally done when they leave the office, especially if there
are no changes in brand or type of lenses. A long-time contact lens
wearer, and particularly a typical wearer of two week disposable soft
contacts who likes his or her current lenses, can probably be examined
and ``fitted'' at a single visit for replacement lenses, according to
the Contact Lens Clinic at the University of Washington.\22\
---------------------------------------------------------------------------
\22\ Contact Lens Clinic at the University of Washington,
www.depts.washington.edu/ophthweb/contacts.html. Downloaded December
13, 2000.
---------------------------------------------------------------------------
But many eye doctors link the practice of ``fitting'' the lens with
the follow-up visit requirement. ``Fitting'' must be ``complete''
before the office will release a prescription. When Laura A. of Austin,
a contact lens wearer of several years, went with her father for an
exam, he disputed the ``fitting'' charge prior to the start of the
exam. Before even looking at Laura's eyes or her prescription the staff
informed him that follow-up was mandatory.
``He was not pleased that we charge the fitting fee since she had
been wearing contacts for several years,'' wrote the optometrist. ``We
explained that even though she had been wearing lenses, we did not have
any record of that and she would need to be treated as a new patient
and return for a follow-up visit.'' \23\ For this office, there was no
distinction between ``fitting'' and the follow-up requirement. And when
Laura did not return for the follow-up visit, the office later told her
father that he could not have her prescription.
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\23\ Texas Optometry Board complaint, TOB#99080, April 23, 1999.
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In some cases, eye doctors link the ``fitting'' directly with the
purchase of a supply of lenses. If the consumer does not purchase a
supply of lenses from the eye doctor, he or she won't ``finish'' the
``fitting'' and therefore does not have to provide the contact lens
prescription to the patient. When the eye doctor is willing to sell
boxes of lenses directly without a follow-up exam, but not willing to
give the consumer a prescription to buy those same boxes somewhere else
without a follow-up exam, he or she is circumventing the law.
Vicki A. of Houston wrote to the Board in 1999 after she was denied
her son's contact lens prescription. Her son Mat was already a
disposable soft contact lens wearer. During the initial visit the eye
doctor examined the boy's eyes, measured them for contacts
(``refitting''), and placed contacts in his eyes. While the eye doctor
was placing the lenses, a staff person explained the charges: $60 exam
fee, $50 for ``fitting'' and unlimited follow-up visits, and $90 for 4
boxes of lenses (a six month supply).
Ms. A. did not want to purchase the lenses from the eye doctor, and
asked if she could have the prescription at the end of the fitting. ``I
asked if I could pay for the trial pair and the fitting charges, and
just get the prescription,'' she wrote. At this, the staff person
instructed her son to remove the trial lenses from his eyes and said
that if she didn't order the contacts her son could not wear the trial
pair home. According to Ms. A., she would have to purchase six months
of lenses ``in order to continue with the fitting'' and come back in
six months for a follow-up visit. At that time, she could finally have
the prescription if she wanted it.
When queried by the Optometry Board, the eye doctor declared that
her son had ``poor hygiene techniques'' and needed six months of
observation. The Optometry Board told Ms. A. that this was ``a matter
between the doctor and patient'' and not within its jurisdiction.\24\
Ms. A. was not the only consumer to complain to the Board that eye
doctors require patients to purchase six months worth of lenses before
finalizing the prescription and releasing it.\25\
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\24\ Texas Optometry Board complaint, [no complaint number], May
24, 1999.
\25\ Texas Optometry Board complaint, TOB#99003, September 18,
1998. Texas Optometry Board complaint, TOB#99106, July 15, 1999.
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Doctors cite two main reasons for requiring follow-ups and/or
requiring the patient to buy the first set or supply of lenses from
them: finalizing the prescription (``fitting'') and liability.
But many patients who have worn contact lenses before do not need
to return for a follow-up visit to finalize their prescription, and eye
doctors have a clear financial interest in bringing consumers back into
their store. This conflict leads consumers to believe that there may be
no medical basis for the return visit for ``fitting'' completion.
People are used to seeing a medical doctor for a problem and having
their prescriptions filled somewhere else. If the prescription is not
satisfactory, they return to the doctor to discuss it. Similarly,
contact lens wearers who have discomfort in their eyes will undoubtedly
call or return to the eye doctor. If they do not return and purchase
contact lenses on their own, the Texas Contact Lens Prescription Act
says that eye doctors are not liable for a patient's subsequent use of
a contact lens prescription.
According to the Act, ``a physician, optometrist, or therapeutic
optometrist is not liable for any subsequent use of a contact lens
prescription by a patient if the physician, optometrist, or therapeutic
optometrist does not examine the patient.'' \26\
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\26\ Occupations Code, Chapter 353, Contact Lens Prescription Act,
Article 353.201.
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insurance
Under the Contact Lens Prescription Act, an eye doctor may refuse
to provide a prescription if the consumer has not paid for the
examination and fitting. Consumers who pay in cash generally pay on the
way out and do not owe the eye doctor money. However, consumers who
have vision coverage through their health insurance may only pay a
copayment or a portion of the charge. If the insurance does not pay
immediately, or if the eye doctor does not file the claim properly,
consumers are told that they cannot have their prescription.
Tangela J. of Dallas went to an eye doctor for a contact lens exam
and fitting. She paid $79 for the exam and contacts, and her insurance
company would pay the office an additional $20. When she returned to
the office to pick up her lenses, she asked for her prescription. The
eye doctor told her that the insurance company had not yet paid the $20
so he did not have to release the prescription. When she called her
insurance company, they said she had paid the correct amount and he
should give her the prescription. She returned to the office again, and
this time got her prescription-but only after the eye doctor confirmed
by phone that the insurance check was in the mail.\27\
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\27\ Texas Optometry Board complaint, TOB#00114, August 28, 2000.
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Insurance companies who cover eye care sometimes prohibit eye
doctors from withholding prescriptions over disputed claims, and
include this in the contract between the doctor and the company. Even
this is not foolproof.
In the spring and summer of 1998, the five members of the H. family
all went to an Austin eye doctor for exams and to renew their contact
lens prescriptions. In September, the family was transferred to Idaho.
Mr. H. contacted the eye doctor to collect their prescriptions and was
told that ``because my insurance carrier had not completely paid on the
claims submitted to them for the services rendered'' the office would
not release the prescriptions. According to the insurance company, most
of the claims had been paid and the only pending claim had been filed
improperly and returned to the eye doctor for refiling. The insurance
company also informed Mr. H. that its contract with the eye doctor
prohibited him from withholding prescriptions over disputed claims.
The family had to move without their prescriptions, and get another
eye exam in Idaho. According to the eye doctor, the delay was the
insurance company's fault. The eye doctor did not deny holding the
prescription while he waited for payment, but he ultimately agreed to
reimburse the family for their repeat exam.\28\
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\28\ Texas Optometry Board complaint, TOB#99057, February 16, 1999.
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No medical doctor outside the eye care arena would consider holding
a prescription hostage to ensure payment of outstanding insurance
claims. Eye doctors have been granted a special right to do this,
regardless of the patient's needs. Insurance companies who prohibit eye
doctors from withholding prescriptions recognize that this not good
medicine, but it will continue as long as it is specifically allowed by
law.
recommendations
In order to ensure greater consumer choice when buying contacts, we
recommend that the Texas Optometry Board:
adequately enforce existing requirements that prohibit optometrists
from attaching across the board conditions to the release of
contact lens prescriptions. Optometrists who require customers
to buy a first supply of lenses from them before they will
release the prescriptions are violating the Texas Contact Lens
Prescription Act.
change its follow-up visit rule to correspond to current law. This
rule as currently written-and the practice of requiring all
patients to return for follow-up exams generally-is not
consistent with the intent of the law. It protects an eye
doctor's contact lens sales by tying access to lenses to the
re-examination process while barring consumers who prefer to
shop online, at discount centers or elsewhere. Rather than
focusing on the health of the patient, this rule creates a
blanket policy for all customers even if they have been wearing
contact lenses without trouble for years.
To encourage competition and ensure access to contact lens
prescriptions, the Texas Legislature should amend the Contact Lens
Prescription Act to:
prohibit eye doctors from filling a prescription that they have
refused to release, unless the refusal is based on the
patient's ocular health as allowed under Section 353.157(b)(2);
prohibit eye doctors from refusing to release a prescription based on
a bill or portion of a bill that remains unpaid due to a
pending or disputed insurance claim;
specify that consumers may collect an original contact lens
prescription more than once while it is valid;
allow dispensers to fill faxed prescriptions with a telephone
confirmation, enabling consumers to effectively access 800 line
and Internet discount firms;
apply the mandatory extension of a prescription to both the length of
time the prescription is valid and to the number of contacts a
person may buy on that prescription. This will ensure that a
consumer who loses or damages a lens or box of lenses can
purchase new lenses without having to pay for another exam.
conclusion
The Texas Contact Lens Prescription Act was intended to give
consumers the right to take possession of their contact lens
prescriptions in order to purchase contacts from the dispenser of their
choice in a competitive marketplace. It has partially succeeded, but
since its enactment some eye doctors have found new ways to protect
their contact lens sales.
By requiring follow-up exams and/or the purchase of a first set or
supply of lenses, eye doctors are limiting consumer choice. They are
instead attaching conditions to the release of prescriptions, which
makes it harder for the patient to buy lenses from other vendors. In
contrast, this is not the case in the rest of the medical field, where
doctors examine patients and release prescriptions to be filled by any
dispenser.
Consumers should have the choice to buy their contact lenses from
other vendors and not be forced to buy boxes of lenses from the doctor
who examined them. Consumers who have worn contacts for a while without
health complications should also have the choice to see the doctor for
the initial exam and then receive their prescriptions instead of having
to return for a follow-up exam. If there is discomfort because of the
lenses, these patients are likely to return to the eye doctor just as
they would with any other doctor who wrote a prescription.
Mr. Stearns. Ms. Venable, welcome.
STATEMENT OF PEGGY VENABLE
Ms. Venable. Thank you, Mr. Chairman, members. Thank you
for inviting me. I am Peggy Venable. I'm State director of
Texas Citizens for a Sound Economy, and I represent 25,000
Texas consumers. We are also the State affiliate of National
CSE, which has a membership of over 270,000. We support free
market public policies and educate citizens on those.
We applaud H.R. 2221 and its sponsors for introducing real
competition and consumer choice into the contact lens market
and working to eliminate the hurdles currently impeding the
consumer's ability to purchase from the retailer of their
choice.
This is an important issue to consumers. I have worked with
our members and other Texas consumers, and I am familiar with
the regulatory hurdles which currently limit consumer choices
in Texas. First, the contact lens consumers are often unaware
that they have the opportunity to shop for contact lens. Of
those who do know they can take their prescriptions to a
retailer, many are frustrated by a system which allows the
prescriber essentially to veto their purchasing decision by
virtue of the positive verification system.
Positive verification requires the prescribing eye care
professional to respond to a retailer's request and to verify
that the prescription is valid and current. Unfortunately,
delays and outright failure to respond to the verification
process eliminate those consumers' choices. That's what I would
like to address today: the challenges that positive
verification place on the consumers' ability to shop.
During the last regular legislative session in Texas, which
ended late May, CSE supported legislation which would have
established a passive verification process similar to
California law. It allowed time for a prescriber to respond.
And if they didn't respond, the retailer would be able to
assume the prescription was valid since it was not challenged
by the prescriber and filled that prescription.
Unfortunately, that legislation did not pass. And currently
Texas process doe not serve the consumer well. The Texas Board
of Optometry acknowledged 2,500 complaints from consumers who
were unable to get their prescription filled. I should note
that of those, their representative in testimony before the
State legislature said only two of those were valid. We found
this assumption and this proclaimant to be outrageous and
irresponsible and a dismissal of those consumer complaints.
Prior to that April hearing in Texas, we contacted around
100 of the consumers who had filed formal complaints. Of those
I talked to personally, none said their complaints had been
addressed. A few said they had been contacted by mail from the
Texas Board of Optometry just days prior to the hearing with a
letter asking for more information.
These consumers are frustrated. Some are angry. And they
felt they had nowhere to turn for help. Of those that had
received a letter from the TBO, there were three that I talked
to. They said they felt the TBO was placing yet another hurdle
in front of them, rather than providing them with answers and
relief.
Now, it's not my objective to impugn the optometrists,
their association, or the board. However, there exists a
practice of failing to verify the prescription, and consumers
have no recourse. The lack of competition appears to reveal a
potential conflict of interest on the part of the prescribing
eye care professional.
It is our objective to find a remedy that allows consumers
access to their prescriptions and promotes consumer choice.
H.R. 2221 addresses that concern by requiring the eye care
professional to provide, to physically turn over to the,
patient a copy of their prescription. This addresses one
problem. But when the consumer decides to purchase online or
over the phone, then the eye care professional must be asked to
verify that prescription. And passive verification seems to be
the only way to address this problem.
In summary, H.R. 2221 would provide relief to consumers and
clarify the role of the optometrist as health care provider
while making their role as potential retailer distinct and
separate and subject to competition. They must be taken out of
the position of being able to deny consumers a choice when
purchasing contact lenses.
Medical doctors don't fill their own prescriptions. When I
take or call my prescription to my pharmacy or an online
retailer, my doctor responds within hours if there are
questions about that prescription. This legislation opens the
door to providing consumers that kind of relief.
And I thank you for the opportunity to appear here today
and share with you our experience in Texas.
[The prepared statement of Peggy Venable follows:]
Prepared Statement of Peggy Venable, Director, Texas Citizens for a
Sound Economy
Mr. Chairman, Members of the Committee, Ladies and Gentlemen. I am
Peggy Venable, state director of Texas Citizens for a Sound Economy and
represent the 25,000 members of Texas CSE. We are the state affiliate
of the national organization, which has a membership of over 270,000
citizens. Citizens for a Sound Economy's mission is to educate citizens
on, and to promote the adoption of, free-market policies, which we
believe benefits consumers and citizens generally.
We applaud H.R. 2221, the ``Fairness to Contact Lens Consumers
Act,'' and its sponsors for introducing real competition and consumer
choice into the contact lens market and working to eliminate the
hurdles currently impeding the consumer's ability to realize the
benefit of an open market in the purchase of their contact lenses.
This is an important issue to consumers. I have worked with our
members and other Texas consumers and am familiar with the regulatory
hurdles which, though originally well intentioned, currently limit
consumer choices in Texas. Consumers care about this issue, and though
some may not choose to purchase their contacts elsewhere, they want and
deserve the opportunity to do so. Some will continue to purchase from
their eye care professional, others will opt to shop for their
contacts. The consumers I've spoken with cite either price or
convenience, or both, as considerations in their purchasing decision.
However, currently the contact lens consumer is often either
unaware that they have the opportunity to shop for contact lenses or
they are hampered in doing so due to the verification process
requirements. Of those who do know they can take their prescriptions to
a retailer, many are frustrated by barriers inherent in the positive
verification process which is used in Texas.
Before a consumer can purchase contact lenses in Texas, the
positive verification system requires the prescribing eye care
professional to respond to a retailer's request to verify that a
prescription is valid and current. Unfortunately, delays and failure to
respond to the verification process thwart the ability of many to
purchase contact lenses from competitive providers.
We would like to pass legislation in Texas to replace positive
verification with passive verification similar to California's, which
would provide the relief consumers need and deserve. That is what I
would like to address today--the challenges positive verification
places on the consumer's ability to shop.
During the last regular legislative session in Texas, which ended
late May, CSE supported legislation which would have established a
passive verification process. The proposal--similar to California
laws--allowed a reasonable amount of time for a prescriber to respond,
and if they did not respond after that period of time, the retailer
would be able to assume the prescription was accurate (since it was not
challenged by the prescriber) and fill the prescription. That
legislation did not pass and was ardently opposed by optometrists.
Texas consumers seeking to shop for contact lenses are left with the
positive verification process, which was limiting customer choice.
The current Texas process is not serving the consumer well. The
Texas Board of Optometry (TBO) acknowledged 2,500 complaints from
consumers who were unable to get positive verification for their
prescriptions. Earlier this year, I personally talked to some of those
consumers who had filed formal complaints and was told that they were
either still wearing their old contacts--which I understand is
potentially harmful to ocular health and an unfortunate consequence of
the current law's limitation on consumer choice--or had gone to another
optometrist, or had returned to their prescribing optometrist and had
their prescription filled there.
I should note that of the over 2,500 complaints acknowledged by the
TBO (though there are some indications that they had received thousands
more complaints), surprisingly, their representative earlier this year
said that they had found only two of them to be valid. We found this to
be an outrageous and irresponsible dismissal of the complaints of
consumers who could not gain access to their contact lens
prescriptions. Many of those consumers I contacted were further
outraged that the Board had not addressed their concerns.
Of the almost 100 consumers we personally contacted who were denied
access to their prescriptions and had filed formal complaints, most
told me that their complaints had either not been addressed; a few said
they had been contacted by the TBO just days prior to the hearing
saying more information was needed. This was frustrating for consumers
and they felt the TBO was placing yet another hurdle in front of them,
rather than providing them with answers and relief.
It is not my objective to impugn the optometrists of Texas, their
association, or the Texas Board of Optometry. However, there exists a
widespread practice of failing to verify the prescription, making
competition moot. The lack of competition is harmful to the consumer
and appears to reveal a potential conflict of interest on the part of
the prescribing eye care professional.
It is our objective to find a remedy that allows consumers access
to their prescriptions and lets them exercise their rights to purchase
from the retailer of their choice. H.R. 2221 addresses that concern by
requiring the eye care professional to provide patients with a copy of
their prescription. But when the consumer decides to purchase online or
over the phone, then the eye care professional must be asked to verify
the prescription.
Consumers are best served when the prescriber has a set period of
time in which they are required to respond to the retailer. Failure to
do so harms consumers financially and may be harmful to their ocular
health.
We have also gone on record recommending a two-year prescription
rather than the one-year expiration period currently mandated in Texas
law. That alone would save each Texas contact lens consumer around $110
a year, the cost of an annual exam.
In summary, H.R. 2221 would provide relief to consumers and clarify
the role of the optometrist as healthcare provider while making their
role as potential retailer distinct and subject to competition. In a
market with potential barriers to competition, they must be taken out
of the position of being able to deny consumers a choice when
purchasing contact lenses.
With an ineffective verification process, only eye care
professionals have the opportunity to fill the prescription which they
write. Medical doctors do not fill their own prescriptions. When I
take--or call--my prescription into a pharmacy or an online retailer,
my doctor responds within a few hours if there are questions.
There are inherent problems with the prescriber also being the
retailer in a market that contains effective barriers to competition.
Unfortunately, those problems have not been addressed in Texas by the
professional board's self-policing practices. The legislation
introduced by Rep. Burr would begin to address not only potential
conflicts of interest, but also the larger question of competition and
customer choice.
We support a passive verification process in which the optometrist
has the opportunity and responsibility to review the prescription prior
to it being filled by the retailer of the consumer's choice. If the
optometrist or ophthalmologist fails to respond within a reasonable
period of time, then the retailer should be able to assume the
prescription is valid and fill the consumer's order.
This legislation opens the door to providing consumers that relief.
Thank you for the opportunity to appear before you today and share
with you our experience in Texas.
Mr. Stearns. I thank you.
I will start with the first set of questions. Let me just
ask Dr. Cummings just as an opening statement, when I decided
that I want to get a book, I can go through Amazon.com or
Barnesandnoble.com and buy it or I could go to the store
itself, some of the stores, Books-A-Million.
Likewise, a lot of senior citizens in my congressional
district buy drugs from Canada. And they go to their doctor.
The doctor gives a prescription. The prescription is sent up
there to Canada, either to a doctor or to a service, and they
get the drugs.
So it seems to me that there is a universal application
here that if a person wants to get their contact lens through
the Internet, they should be able to. Do you agree with that?
Mr. Cummings. Yes.
Mr. Stearns. Okay. So, then, if you're the doctor, you're
my optometrist, I come to you and ask for the prescription so I
can have it on my own, you have no objection?
Mr. Cummings. No.
Mr. Stearns. Okay. So then I take this and give it to the
1-800, and we have completed that. Now it turns out that the 1-
800 needs the prescription and they want to call you for it.
What is your objection specifically from just giving it to them
if I give you the okay? If I say to you as a patient, ``It's
okay to give it to the 1-800,'' why wouldn't you want to give
it?
Mr. Cummings. I have no objection to verifying the
prescription with 1-800.
Mr. Stearns. So I say to you, ``I want to have this 1-800
call you. Please verify it''?
Mr. Cummings. Yes.
Mr. Stearns. So right now based upon what I just told you,
it seems like you would support the bill.
Mr. Cummings. If there were certain safeguards put in place
around the verification process.
Mr. Stearns. So we're at this point where what I hear from
you--I've heard both sides in the opening statements--what I
hear from you--and you're the main person here who would be the
person objecting to the bill--is that you support the bill with
reservations. Is that an accurate statement?
Mr. Cummings. That's accurate.
Mr. Stearns. Okay. And the reservations are you just want
to ensure safety for the patient; and, two, you want to ensure
that there is no culpability on the optometrists' part because
the 1-800 fusses up the prescription?
Mr. Cummings. Correct.
Mr. Stearns. So those are the two reservations?
Mr. Cummings. Yes.
Mr. Stearns. And if we put in place in this bill and
convince you that we have that, then you would support the
bill?
Mr. Cummings. If the safeguards are put in place totally so
a person cannot get contact lenses without a valid
prescription, then we would----
Mr. Stearns. Okay. So you said you would support the bill
with the two reservations. Now it's just a question of whether
the author of the bill and the people on the subcommittee
believe that those reservations are already taken care of.
Now, it appears two-thirds of the States in the union
support this idea and have already passed a bill something like
this. Isn't that true?
Mr. Cummings. Two-thirds have passed a legislation that
mandates that a contact lens prescription has been released----
Mr. Stearns. Prescription release.
Mr. Cummings. Prescription release. Now----
Mr. Stearns. Yes. And you support that idea?
Mr. Cummings. Yes. Now, States have----
Mr. Stearns. You have no objection to any of these two-
thirds State laws that were passed by State legislators----
Mr. Cummings. Some of them we do, not on the prescription
release piece of it.
Mr. Stearns. Okay.
Mr. Cummings. But on the verification piece of it, we feel
that some States have better verification than other States.
Mr. Stearns. Okay. Ms. Martinez, is there any kind of
public education campaign in Texas to inform consumers of their
rights relative to contact lens prescription release that you
know of?
Ms. Martinez. I have never seen any campaign.
Mr. Stearns. Ms. Venable, are you or----
Ms. Venable. I'm unaware of no public education regarding
that.
Mr. Stearns. Mr. Beales, what was the impact of the FTC's
eyeglass rule after it was implemented? Do you expect the same
results from this legislation for the contact lens market?
Mr. Beales. Well, when the Commission's Eyeglasses Rule was
originally implemented, the state of competition in the market
was very different. There were very few third party providers.
There were very few commercial providers. There was much less
competition at that point than there is today. And it's clear
that since the rule, there has been a great deal more
competition, much lower prices for eyeglasses. It has
undoubtedly facilitated that.
In the contact lens market, there is a lot more competition
already. And, as we said, it's not clear that consumers who
really want their prescriptions and want to buy elsewhere have
a systematically difficult time getting them. Undoubtedly, some
consumers don't. Some consumers do. So it's not clear we would
have the same kind of effect. I think, clearly, it would be
more competitive, but it probably wouldn't be as significant
because the market is more competitive to begin with.
Mr. Stearns. You mentioned that you endorse a specific
verification system. Do you have a preference on active or
passive verification?
Mr. Beales. We don't have a point of view. We're not very
well-placed to balance----
Mr. Stearns. So you can't tell us this morning which of
those two you support?
Mr. Beales. No. We would urge that you choose one.
Mr. Stearns. You won't give us any guidance?
Mr. Beales. We don't have an opinion about which one would
be the best way to go.
Mr. Stearns. Why don't you have an opinion? It doesn't seem
that complicated.
Mr. Beales. Well, there is a clear advantage to the passive
verification system in that more consumers will be able to buy
through third party providers. There is a disadvantage or an
advantage to the active verification system, if you will, that
it avoids the risk of contact lenses being provided based on
expired or out-of-date prescriptions. And we don't have either
the knowledge or the expertise to balance those risks. But that
we think is the issue.
Mr. Stearns. So I guess you couldn't comment, then, on the
health concerns relative to active verification, what health
concerns? Are there any health concerns with active
verification or passive, either one? Any health concerns at
this hearing we should be concerned about?
Mr. Beales. Well, there are health concerns that have been
raised about passive verification. We do not know of any
systematic evidence about the extent of those problems or of
the actual existence of problems. The possibility of problems
numerous people have pointed to. We think those possibilities
are real. We don't have any evidence about the extent to which
those problems are actually there.
Mr. Stearns. It's hard to pin you down here. If I come back
in 3 months, will you have an answer to these questions?
Mr. Beales. Well, the difficulty that the Commission has in
this area is we really don't have the expertise. And it's why
we have reservations about the study. We really don't have the
expertise to evaluate the medical set of issues. There is a
medical set of issues here, where we are not the best people to
offer advice or to reach conclusions.
Mr. Stearns. I will just conclude. I think in the bill, we
allow you to work with the FDA. And so that should be helpful
to you in coming up with solutions to these problems.
Mr. Beales. It certainly would be helpful, and that is
certainly what we would do if we needed to do that because we
would need to tap that expertise.
Mr. Stearns. I welcome the ranking member, Ms. Schakowsky,
for questions.
Ms. Schakowsky. Mr. Chairman, if I could briefly give parts
of my opening statement, I would appreciate the opportunity.
Mr. Stearns. I'm going to give you 5 minutes. Then we'll go
back to a second round. So you are welcome to do what you want.
Ms. Schakowsky. I want to thank you, Mr. Chairman, and all
the witnesses that have been here today. I am really pleased
that you have been focusing on H.R. 2221. Thirty-six million
Americans use contact lenses. And these are really serious
issues.
I know that many of my colleagues on the committee have
spent a great deal of time studying the subject, including Mr.
Burr and Mr. Dingell and Mr. Waxman. At this point, I would
like unanimous consent that the testimony of Congressman Pete
Stark, who has been working on this issue on behalf of contact
lens consumers for over a decade, be submitted for the record.
Mr. Terry. Without objection.
[The prepared statement of Hon. Pete Stark follows:]
Prepared Statement of Hon. Pete Stark, a Representative in Congress
from the State of California
First I'd like to commend Chairman Stearns and Ranking Democrat
Schakowsky for holding this hearing. This might not be a high profile
issue, but it is important to the 35 million of contact lens wearers
around the country. Eyeglass wearers have enjoyed unobstructed access
to their eyeglass prescriptions since the Federal Trade Commission
issued regulations in 1978 requiring their automatic release. Yet,
twenty-five years later, similar action has yet to be taken for contact
lens wearers.
I got involved in this issue more than a decade ago when my wife
asked her eye care provider in D.C. for her contact lens prescription
so she would have it if she needed it while we were in California. To
her--and my--astonishment, the provider refused to give her the
prescription saying that the law did not require him to do so. We
checked it out and he was correct. I've been working to fix this
problem ever since.
The simple fact is that contact lenses are fast replacing
eyeglasses as the corrective instrument of choice for consumers.
Despite this trend, many states allow prescribing eye care
professionals to refuse to release contact lens prescriptions to their
patients. Eye doctors cite health concerns, but the fact is that they
have a strong financial incentive to restrict consumer access to the
contact lens market. Without their contact lens prescription in hand,
consumers are forced to purchase their lenses from their prescribing
eye doctor--who obviously profits from each and every sale.
Over the years I've introduced several bills to require the release
of contact lens prescriptions. In the last Congress, I introduced HR
2663, the Contact Lens Prescription Release Act. This bill, which was
cosponsored by Rep. Burr, included mandatory release of patients'
contact lens prescriptions to patients directly or to the agent of
their choice. It also required that upon request eye care providers
promptly verify the accuracy of a patient's prescription.
Toward the end of the 107th Congress, Rep. Burr took the lead to
introduce a revised version of the bill which many of us on both sides
of the aisle signed onto in hope that it could be quickly enacted.
Unfortunately, the session ended without resolution of this issue.
This year, Rep. Burr has introduced a new version of that
legislation, HR 2221, the Fairness to Contact Lens Consumers Act. I am
not a cosponsor of this bill because I'm concerned that it lacks any
enforcement mechanism or any mechanism to provide for presumed
verification. Without at least one of these components, passage of the
introduced bill would not fix consumers' widespread inability to
purchase contact lenses from someone other than their eye care
provider.
I look forward to continuing to work with Reps. Burr, Tauzin,
Dingell, Schakowsky, Waxman and others to complete years of effort in
this endeavor. We should update the law to enable consumers to be able
to obtain their contact lens prescriptions and be freed to safely
purchase contact lenses from the provider of their choice.
Again, thank you for holding this hearing.
Ms. Schakowsky. I believe that we all agree that current
law must be changed so that consumers are explicitly entitled
to a copy of their contact lens prescription from their doctor.
There have been reports of their eye care providers
unnecessarily preventing or delaying consumer access to their
own prescription.
I wasn't here, Ms. Martinez, for your testimony. That's the
only one I missed. I'm sorry. But I appreciate the testimony of
a consumer like yourself.
While consumers clearly have a right to shop for the best
deal when purchasing contact lenses, the challenge to us today
is, as many of you have discussed, balancing patient safety
with the interest of getting the best price for contact lenses.
One of the issues I wanted to raise with you was the issue
that was brought to me by Dr. Robert Panton, an ophthalmologist
in Elmwood Park, Illinois from the State I am from. Mr. Panton
has provided me with a vendor verification request that gives
him 8 business hours to respond.
I will want to ask whether or not any of you have
concerns--I know some have been raised--about whether 8 hours
is a reasonable time to respond. He raises the question, how
does this relate to solo practices, where a practitioner may be
out for the day because of illness or to attend a medical
conference? Is it a sufficient safeguard to make sure that the
FDA valid prescription requirement is met?
Particularly because we are imposing enforcement penalties
on physicians who fail to comply with specific requirements, I
am concerned that leaving the verification process solely in
the hands of vendors may be unfair. And I want to make sure
that we carefully study the balance here as we move forward on
this legislation.
I realize that H.R. 2221 requires a study of these issues.
But since the FTC has already been studying these issues and
believes that more specificity is needed in the verification
process, I hope that we will explore the possibility of setting
clear verification requirements in the bill, whether passive or
active, in defining reasonable time lines.
And if our top priority is, in fact, protecting consumers,
then we have to consider whether there are appropriate
penalties for vendors and doctors that violate the terms of the
legislation or if we should include stronger enforcement
action. And I want to join Mr. Stark in raising concerns that
this bill max any enforcement mechanisms for individuals'
private rights of action or State attorneys general or any
mechanism to provide for presumed verification.
Finally, I want to ask the witnesses why this process
shouldn't be set up just like the process works for other
physician-prescribed medical products. If I want to get a
prescription delivered to the Capitol from Grubbs, my doctor
calls the pharmacy and confirms the prescription for me. This
process protects me as the patient, the pharmacies, and
doctors. And I am not sure why we should treat contact lenses
any differently.
So I look forward to working with the committee, with all
of the experts in this. And certainly I am pleased that
Consumers Union is here to present the consumer point of view
as well and look forward to being able to draft after a long
time of considering this legislation a bill that will protect
consumers in every way.
Thank you, Mr. Chairman. Do I have a minute? Yes, I have 30
seconds.
Mr. Stearns. If any of the committee would like to respond
to any of your inquiries, the witnesses?
Ms. Schakowsky. Yes, Mr. Coon?
Mr. Coon. Yes, ma'am. Clearly an ideal system is exactly
what you have described, a medical doctor-pharmacy system. We
are entirely supportive of that system, as we were in
California and in every other forum. And if the AOA is
supportive of that system in which a medical doctor does not
sow what they prescribe and the parameters for response are
completely undefined, we totally support a system like that.
Mr. Stearns. All right. Did you want to say something, Dr.
Cummings?
Mr. Cummings. Yes.
Mr. Stearns. Sure.
Mr. Cummings. I think you pointed out very well some of the
problems we see with the passive verification system. With the
medical model system, it is cut and dry. And there is a paper
trail that the prescription was truly verified.
If you impose penalties on the provider for not providing
the prescription or providing verification, then that is the
reason why a passive verification system kind of came up, the
fear that the provider would not comply with the law. But if
you put enough penalties on the provider to comply with the
law, then I believe a positive verification system will work.
Mr. Stearns. The gentlelady's time has expired. Mr. Shimkus
is recognized for questions.
Mr. Shimkus. Thank you, Mr. Chairman.
Mr. Coon, there have been some questions about the
techniques companies like yours use to verify orders for
contact lens prescriptions and problems such as automated cause
and continuous faxes inhibiting optometrists from verifying
prescriptions. Could you just go through your procedures for
me?
Mr. Coon. Sure. I would be happy to. There has been a lot
of confusion about what our systems are. There are a lot of
other companies that do either no verification at all, as Dr.
Cummings described. There are other companies that have
different systems.
Frankly, there is really only one system that is at work.
It's the law in California. In fact, one brief quote from the
California Optometric Association, they said that this law was
``an example of numerous parties collaborating to provide
patients with the best possible health care.'' We were able to
work with ophthalmologists and optometrists in California to
come up with this solution.
To walk through our process, what happens is somebody calls
us and they're either on the Web half the time or they're
calling us on the phone. Seventy percent of our customers are
female. So I tend to say ``she.'' She'll usually read us the
parameters off the box. Again, there's just a size and a power.
So she is going to read those to us. But over the Internet,
there really isn't a way to convey a piece of paper over the
phone either.
So we'll require a doctor's name and telephone number that
is valid. We contact that doctor's office. The system that
works, the system in California, the system that we do with our
Johnson and Johnson orders Nationwide, is that we're faxing.
And the best part about a fax is that there is a handshake that
takes place between the two fax machines and a confirmation
that you know your fax went through and it was received by the
other party.
Now, we don't start the clock that was described earlier,
the 8 business hours, until after a successful fax has been
sent. No successful fax will wait indefinitely.
So in an example where, say, the doctor is not there,
they're out of town, they could tell us that the doctor is not
in, although usually when the doctor is out, the store is open
and there is usually a staffer there who could respond. But
even if there isn't, they could tell us or they could unplug
the fax machine.
But we're going to send that fax through, and then in
writing, the doctor has a confirmation request that ``Sally
Jones is ordering Acuvue lenses in this size and in this power.
And you have this amount of time to respond. And if we don't
hear back from your office that there are any corrections or
problems with this prescription, then we're going to assume
it's correct and ship that order.''
That's the law in California. And it's a compromise. It's a
compromise that addresses the fact that eye doctors sow what
they prescribe.
The only way to have a physician-pharmacy system is when
physicians don't own their own pharmacy because otherwise they
might be inclined not to respond to competing pharmacies.
So short of that, which, again, we accept as the ideal and
the best solution, short of that, this system was a compromise
that would allow eye doctors to continue to sow what they
prescribe.
Mr. Shimkus. Thank you. My colleague Ms. Schakowsky is from
Illinois, probably has more knowledge in Illinois than I do,
but it's my understanding that in Illinois, we actually have to
submit a written request to our optometrist if we want that
prescription to be used elsewhere. And so that would be even a
more difficult hurdle to overcome in this whole process, would
it not?
Mr. Coon. It absolutely would. In fact, what some eye
doctors do in some States is, again, they own their own store.
They will actually not only require a release form, but they
will demand that the customer come into their store, where they
happen to sell contact lenses, and sign it in person.
Mr. Shimkus. Yes. I am a contact wearer. So I know all of
this. My optometrist is a friend from the church in the
community. And I do fear asking him to give me that to go
elsewhere because we are close friends and associates. So I
think I am going to stay with him.
But I do understand how someone who would want to--or, in
fact, we travel a lot. And I'm not in Collinsville. I'm here a
lot of times. And if, for some reason, my supply runs low, then
I could go to a 1-800 mail order and get it shipped here, which
would be helpful, although I know now that my optometrist says,
``We can get it mailed to you from our location.''
So there is competition. This is an interesting hearing.
And I'm going to keep my contacts for a while, and I'll yield
back my time.
Mr. Stearns. Thank the gentleman.
Mr. Terry?
Mr. Terry. Thank you, Mr. Chairman. I was just thinking
that, John, perhaps you can ask Mr. Coon what the price of your
prescriptions would be for your contacts. And then you could
have your friend and fellow church member match that price.
I don't wear contacts. And, frankly----
Mr. Shimkus. You don't?
Mr. Terry. Yes. I know that surprises you, John. I've got
to admit that this was not an issue I had spent a great deal of
time on until an optometrist came to my office about 2 weeks
ago and even told me this bill existed.
So I want you, Mr. Coon, Dr. Cummings, to help me work
through the two differences between the passive, Mr. Coon, that
you feel would be the best option. And then I want you to
compare that to the methodology of verification expressed by
Dr. Cummings on behalf of the American Optometric Association.
So, Mr. Coon, will you go first?
And you can give me kind of some of the stories that there
are; some accusations perhaps that some eye physicians kind of
game the system in order to keep their patients from going to
you.
Mr. Coon. I think what you point out is an important point,
that the reason they sort of game the system is that there is
an economic motivation to do so. It is kind of foreign to
people who haven't experienced it as well because it doesn't
make sense that a medical doctor wouldn't respond to somebody
acting in the role of a pharmacy.
But the two key differences, I think one important point to
make before going into those is that our customer on average
has been wearing contacts for 5 or 6 years. They're already
wearing contact lenses when they contact us.
So we're not comparing somebody wearing contacts to not
wearing contacts. What happens with our customers if we use
Texas, which is positive verification, what happens with our
customer is that over half of the time in that system, since
the customer has to wait indefinitely until the doctor
responds, more than half our orders are canceled for no reason
other than the fact that the eye doctor doesn't respond because
they don't want to.
Responding is giving a competitor permission to make a sale
to their customer. And they don't want to. As they wait,
customers cancel their orders. And many give up and go back and
say, ``Forget it. I'll just buy from my eye doctor.'' What
happens with many others, though--and these are the risks
associated with positive verification--is what is also very
common is people just keep wearing the lenses they have.
So a box like this has six lenses in it. This could be a 3-
month supply if I throw them away every week. It could be a 6-
month supply if I throw them away every 2 weeks. It could be a
1-year supply. It could be a 3-year supply if I throw them away
every 3 months.
Now, the risks of wearing them longer are that they buildup
deposits, people get infections. Sometimes you'll somebody with
red eyes who wears contacts. And they'll say, ``I've got to
throw these away. I just don't have time to deal with it''
because it's a hassle to replace them. And so the more it is a
hassle to replace contact lens, the less frequently people are
going to throw them away.
And this was one of the arguments that maybe Mr. Hubbard
could speak to because the attorneys general made it in their
lawsuit against the American Optometric Association and others
that these sorts of systems restrict consumer access to the
very replacements that would reduce their risk because they
would be clean, new lenses.
So, on the one hand, you have people forced to get an
affirmative response from the doctor's office every single
time. And, as a result, doctors can veto their choice to buy by
doing nothing, by just not responding.
Under a presumed verification system, the doctor has a
motivation to tell us we can't sell, right? So they tell us if
there is any problem with the prescription, if it's expired, if
it's invalid, whatever the problem is with the prescription. If
they can tell us, you can believe they tell us absolutely every
time.
In California, for instance, 25 percent of the time, we are
not able to fill the order because we are told by 2 p.m. the
following day, which is California law, that there is a problem
with the prescription and we don't----
Mr. Terry. I want to get Dr. Cummings to have a response to
your presumed verification. That sounds like a reasonable
middle ground here.
Mr. Cummings. Well, there's a challenge with presumed
verification. I could give you an Internet address, and you
could take the numbers off of a box like this, maybe a spouse
or a son or a daughter or a friend, and call them up and get
contact lenses dispensed to you. And the problem with passive
verification is that people will get contact lenses without a
prescription.
Now, the number may be less, but people will be able to get
contact lenses, either over the Internet or from other
suppliers, without having a valid contact lens prescription.
That's the down side, too.
Mr. Terry. How about the California version, where there is
period of time in which to verify and then they can presume
verification if there is no reply. So you can't game the
system, like some of the eye physicians in Texas do.
Mr. Cummings. Sure. One of the problems I see with the
California--I think the California is good in many respects
because it addresses many of the issues around the release of
the contact lens prescription and that type of thing, which we
feel is good.
The problem is I still think you can game the system with
the passive system in California. And I think that some of the
suppliers of the lenses will be able to continue to provide
lenses to people who either have expired or don't even have
contact lens prescriptions or as in the case that I mentioned
in my testimony, that they substitute a lens that was
inappropriate for them.
So the potential exists in a passive verification system to
still have that happen.
Mr. Terry. I know my time is up, but let me just conclude
with this last question. So it would be the position of the
American Optometric Association that you don't want any form of
presumptive with the time, but you are willing to go with some
sort of heavy penalties perhaps to the eye physician if they
don't verify within a time period?
Mr. Cummings. Yes.
Mr. Hubbard. If I might add, Mr. Coon mentioned that we
were engaged in enforcement proceedings. There was a lot of
stuff that went on in the disposable contact lens litigation,
including arguments that the practices of companies like 1-800
were illegal.
There have been many complaints to State boards throughout
the country that it is illegal. No board that I am aware of has
ever proceeded against that system for I think very valid
reasons, which is they don't show consumer harm from it or
anything else.
The point is that consumers should not be stuck in the
middle of this. The consumer should not be burdened by a non-
responsive ECP. If it's the ECP's problem, they are notified of
that. They have an opportunity to correct errors. An ECP
shouldn't be allowed to with silence veto a sale by a
competitor just because it's anti-competitive or they're
inefficient or they're non-responsive.
If there's a problem with 1-800 not doing the verification
that they say is required, there is a way to deal with that.
The problem is that in the positive verification format, it is
the consumer and the consumer primarily who suffers.
Mr. Terry. Thank you.
Mr. Stearns. We're going to do a second round. Mr. Burr? We
will let Mr. Burr, who was the author of the bill, go ahead.
Mr. Burr. Mr. Chairman, thank you. I appreciate the
indulgence of my colleagues since I am not a member of this
subcommittee.
Mr. Hubbard, let me ask you just one question. Why is this
so confusing to get to an end on a legislative remedy?
Mr. Hubbard. I don't know. Maybe it's my articulateness is
not as good as it should be. It is different I think than a
whole lot of industries. It is correct that very few doctors
sell what they prescribe. It creates a whole different series
of incentives.
There are many ways that you can make it hard for consumers
to get their prescription. One of the parts of the litigation
was they would train one another about how you wouldn't let the
prescription walk out the door.
There are a lot of subtleties that arise because of this
incentive and that a large proportion, a significant
proportion, of an ECP's revenue comes from the sale of these
contact lenses. And that's what creates the significant
problem, I think.
Mr. Burr. So what you're telling me is it's financial?
Mr. Hubbard. Yes. It's undeniable that the business
strength of some ECPs depends in large measure on the number of
contact lenses that they sell.
Mr. Burr. Certainly optometrists suggest that this is about
patient care, that it's all about patient care. In essence, to
listen to them, you can't rely on a prescription that they
write to either be filled in the right way or for a patient to
handle that prescription with a correct vendor.
Mr. Hubbard. Well, I think that consumers are able to do
that. I think that a prescription needs only a few parameters
in order to specify what lens should be sold.
Certainly the ocular health of consumers is something that
interests the attorney generals. And we certainly were asked by
our bosses to make sure that the position that we were taking
in the litigation was not risking the ocular health of
consumers. And we took those concerns very seriously.
We always when we had an optometrist under oath said,
``What evidence of ocular health risks are there? Can you
document that?'' That was always what we asked. And we never
got documentation of those risks.
We take ocular health concerns very seriously. And we
looked at those in a lot of depth. We don't profess to be
medical doctors. But we think that the passive verification
fulfills the purposes that consumers are entitled to.
Mr. Burr. You certainly are the only one at the table, I
believe, that has litigated something relative to this. Let me
ask you, the results of that litigation basically required what
to take place?
Mr. Hubbard. Well, there was a whole series of we allege
that there were damages, there were benefits packages, other
things. I think your question mostly focuses on the kind of
injunctive relief that we had.
With the manufacturers, we required reasonable and
nondiscriminatory sales to mail order and pharmacies along with
everybody else. So that was J&J, B&L, Ciba.
As to the AOA, we had various claims. there is a provision
that they shall not oppose prescription release. There is a
provision that they shall not make health care claims unless
it's supported by valid statistical data. Those were the kinds
of provisions that we put in the settlement were the results of
that litigation.
Those settlements are publicly available. I would be more
than happy to give you----
Mr. Burr. Is it your belief that we need to pass this
legislation to assure that patients across this country have an
option other than their ECP for their contact lenses?
Mr. Hubbard. This would be a significant step forward, yes.
Mr. Burr. Mr. Coon, how does 1-800 currently request doctor
verification?
Mr. Coon. Well, the best system that we have found works
the best, which we do in a majority of our orders--and there
has been criticism of phone automated systems and other things.
The system that works the best is in writing by fax. We know
that there is a confirmation that it was received. And that's
the system that we would recommend.
Mr. Burr. And if, for some reason, there was not a
response, which clearly is a problem today, can you give us an
idea from 1-800's perspective? How much of the time does that
happen?
Mr. Coon. Well, it depends on what the law is in the
different States, like in Texas, over half the time, we cancel
the order. It's a fax, too, but it's a positive verification
system. And so over half the time, the eye doctor doesn't
respond.
The data, the statistics aren't that much different in a
presumed verification State like California. The difference is
they tell us if there is a problem. They don't tell us if there
is no problem. In fact, that is acceptable in California
because by 2 p.m. the following afternoon, it's just one more
thing the doctor doesn't have to do. If they pull the record
up, the prescription is current and it's valid. They don't have
to respond, you know, if there is not a problem.
I would point out that in either system, again, the doctor
has ample opportunity to tell us that we can't fill an order.
If there's any problem at all with that prescription, we know
that is a valid doctor's name and phone number, we know that is
a valid fax, we know they have received the communication. And
if they tell us that there is a problem with the prescription,
we will not fill it.
Mr. Burr. Mr. Chairman, I realize I have run out of time.
And I think we are going to have----
Mr. Stearns. We are going to have a second round, yes.
Mr. Burr. Thank you. I yield back.
Mr. Stearns. All right. I will do just a few questions, and
then we will go around again. Mr. Hubbard, let's see if we can
get to the point here. If you had to recommend a verification
standard, would you today recommend an active or passive
standard?
Mr. Hubbard. Passive.
Mr. Stearns. Active?
Mr. Hubbard. I said passive.
Mr. Stearns. Passive, passive.
Mr. Hubbard. And, Your Honor, I note that the litigating
States or 32 of us, we took that position in enforcement
proceedings after the settlement. We took the position that the
settlement wasn't being followed and that the primary dispute
in that was whether positive verification was required or
passive was enough. And we took the position as a group of
States that passive verification was sufficient.
Mr. Stearns. Would you support preemption of State law?
Mr. Hubbard. Well, you know I represent a State. And
preemption is an extremely hot issue, and it depends very much
on the details. I would have to know what you are talking about
and----
Mr. Stearns. How about this bill, dealing with this bill?
Mr. Hubbard. Well, in the current version of the bill, I
don't see preemption of any State laws.
Mr. Stearns. But if we did include it in the bill.
Mr. Hubbard. What would be the nature of the preemption?
Mr. Stearns. For the passive system which you are talking
about.
Mr. Hubbard. So that to the extent there was a positive
system in a State, it would be overridden by the passive?
Mr. Stearns. Yes. So you have in the bill the passive
standard and it would preempt State laws.
Mr. Hubbard. Well, I can with confidence say that that
would be fine with the State of New York. I have not discussed
that issue with other States.
Mr. Stearns. With your boss.
Mr. Hubbard. The position that we took in the litigation
was that 1-800 system was appropriate under the law of all of
the litigating States, that be Arkansas, that be a whole series
of States. That's an acceptable procedure. So by definition,
the passing of Federal law that permits passive verification
does not preempt State law because State law currently permits
passive verification.
Mr. Stearns. Okay. Ms. Gadhia, according to your study,
some eye doctors require a patient to sign up for a long-term
contract of ongoing care. And if they are not available for
that ongoing care, they cannot have their prescriptions. What
is the medical rationale for this practice? And how prevalent
is that practice today?
Ms. Gadhia. As far as the packaging or requiring the
extended follow-up visits?
Mr. Stearns. Yes.
Ms. Gadhia. Our 2000 survey showed that, as I mentioned, 57
percent of doctors were requiring follow-up visits. If there is
a medical necessity for the follow-up visit, that is, of
course, up to the eye doctor. But what we are concerned about
is when it is not medically necessary and it's considered just
a way to sort of keep the prescription hostage.
Mr. Stearns. Okay.
Ms. Gadhia. I hope I have responded to your question.
Mr. Stearns. Ms. Venable, you heard Mr. Hubbard. And he
talked about what passive verification system he is supporting.
You also indicated in your testimony that you are also
interested in replacing the active verification with a passive
verification system. Have you encountered much resistance to
this idea?
Ms. Venable. Absolutely. Yes, sir, we have. In Texas, the
law that was introduced this last legislative session would
have allowed for passive verification. And that law was
strongly opposed by optometrists in the State.
Mr. Stearns. So how is the campaign going, then? Has it
reached a standstill or----
Ms. Venable. Well, in Texas, we made only every other year
for 5 months. So we have a period of time where we have no
relief for the consumers who are unable to get their
prescriptions filled other than them going back to their own
optometrist or another optometrist to get a prescription that
will be verified. I've talked to a number of people who have
done just that.
Mr. Stearns. So the optometrists have been effective in
their lobby work in this case?
Ms. Venable. Yes, sir, they have.
Mr. Stearns. Dr. Cummings, anything you might want to add?
Maybe your comment is that they have been effective because you
have been right.
Mr. Cummings. Well, I actually believe that the Texas law
is actually a very good one. The safeguard that is built into
that is that if a practitioner does not verify or provide the
prescription to the patient, they can lose their license. I
mean, it's in the law. They can actually lose their ability to
practice and earn a livelihood if they violate the tenets of
the Contact Lens Act.
Mr. Stearns. Okay. Anyone else? Mr. Coon?
Mr. Coon. Having attempted to fill 100,000 orders under
that system in Texas, we have a little bit of experience with
what actually results.
Yes, that's true. Under Texas law, an optometrist could
lose their license. As a practical matter, though, not only do
they control more than 90 percent of the market. They also
regulate themselves. They run the Optometry Board. It's made up
of optometrists.
This is just a sampling of the 4,000 handwritten complaints
that consumers have filed, not our company. We filed 40,000 for
no other reason than the doctor wouldn't respond. These are
4,000 handwritten complaints from consumers.
Mr. Stearns. Those are 4,000 right there, that----
Mr. Coon. This isn't 4,000. This is just a sampling.
Mr. Stearns. That would be impressive if it were.
Mr. Coon. No. This is just a sample of them. I will just
read the first one in the record. And I would be happy to
submit these samples. And we have a CD that has all of them if
somebody wants to go through them at random.
Mr. Stearns. I don't think we need to submit them all, but
you are welcome to put one in the record.
Mr. Coon. Here is one example. Again, the Texas Optometry
Board took no action against any optometrist that we're aware
of. No one lost their license. No one got a letter from them
that we're aware of.
Here's a perfect example. This customer in her writing, her
handwriting, says, ``In fact, I was told by one employee they
just ignored all requests sent to them by 1-800-CONTACTS. She
said it was their policy not to do business with 1-800-
CONTACTS, regardless of what patients wanted.''
Now, that's a perfect example of where why did that
optometrist not lose their license. I mean, obviously they
don't want to do business with 1-800-CONTACTS because doing
business with 1-800-CONTACTS means giving your patient
permission to buy from a competing----
Mr. Stearns. But just between you and me, I'm not sure you
want to do business with every 1-800 either, would you?
Mr. Coon. Well, it's hard to empathize with somebody who is
in the position of selling what they prescribe. So I don't know
what I would do if I were put in that position. It's not a
position I would like to be in.
Mr. Stearns. I think we have got an interest here. My time
has expired.
Would anyone else like to comment? Yes, Dr. Cummings?
Mr. Cummings. I would like to comment on the text of the
3,000-4,000 complaints because we have heard a lot of those
over the years.
There is a due process that has to take place when you sit
on a State board. And when a State board receives a complaint
like that, especially when it could result in fines or the loss
of a license to practice a person's livelihood, you have to
take each one of those and investigate them fully.
And it's my understanding that the State board of optometry
is no different than any other regulatory board in any of the
States. They're made up of practitioners of that particular
discipline. Be it optometry and medicine or nursing or
whatever, they also have a public member on that board. And
their counsel is the attorney general of the State.
So the concept that somehow the State board is going to
fool with these things I think is not accurate. I think that
they have a duty to the citizens of their State who they serve
as State board members to fully and accurately investigate
every one of these 4,000 or however many they are. And that is
going to take time. It is my opinion that they worked through
many of them and that they have taken action against certain
practitioners.
And I think that you could ask the State board in Texas for
a summary of their action on that and include it in your
record.
Mr. Stearns. My time has expired. The gentlelady?
Ms. Schakowsky. I wanted to follow up more on this whole
question of enforcement. Mr. Beales, my understanding is,
particularly for those States that don't have any law--and
then, of course, the question of preemption comes in, too--is
it not true that if a consumer doesn't receive a prescription
from her ECP, then what recourse does the consumer have other
than to file a complaint with the Federal Trade Commission?
Mr. Beales. Well, what recourse they would have would
depend on State law. At this point, there's not any Federal
recourse that I know of.
Ms. Schakowsky. Well, then would you not be responsible for
monitoring and enforcing the violations of this bill? Wouldn't
the Federal----
Mr. Beales. I'm sorry. Under the bill, under the act, yes.
I thought you were asking about right now.
Ms. Schakowsky. No, no. Under the bill. I'm sorry. So are
you equipped to do that for lots of complaints that would come
in?
Mr. Beales. Well, it depends on the number of complaints.
And what we do in any of the areas we regulate because we are a
small agency is we pursue the largest and most appropriate
targets. And we try to achieve general deterrence through those
actions.
But no, we would not be able to pursue each and every
individual complaint. And that's what we do in any other area.
Ms. Schakowsky. Well, that's my concern. Ms. Gadhia, H.R.
2221 does not allow individual consumers to enforce the bill's
protections in court. And it doesn't empower, as I understand
it, State attorneys general to protect their citizens. So do
you believe that the current enforcement mechanisms are
sufficient?
Ms. Gadhia. We support both FTC enforcement as well as
protecting the right of consumers to turn to their State and
local enforcement authorities, whether it's attorneys general
or district or county attorneys, as well as a private right of
action. So we think that that is an important recourse for the
consumer.
Ms. Schakowsky. So those provisions, however, are not in
the current legislation. Is that right?
Ms. Gadhia. My personal opinion would be that it's not
clear. It's not explicitly in the legislation, certainly. The
Texas law that we have experience with does allow for State and
local enforcement. And it does allow for injunctive and
administrative remedies. That's an important thing to preserve,
we think.
Ms. Schakowsky. Let me ask Mr. Hubbard what you think about
that.
Mr. Hubbard. Well, the dispute here between what is going
on in Texas, you know, you're talking about a remedy about
whether doctors should lose their license.
I think that one of the important things is that the
consumer should not get caught up in the middle. And a State
attorney general, for example, tries to keep the interests of
consumers in mind. And while there is a due process evaluation
of whatever an optometrist did in Texas, we want a consumer to
have her lenses.
We think that in many contexts, enforcement authority by
both Federal enforcers and State enforcers has worked very
well. We have a longstanding relationship with the FTC where we
cooperate, where there are certain things that we emphasize and
certain things that they emphasize. We think that this is
another area where such a concurrent jurisdiction would be a
fruitful way to proceed.
Ms. Schakowsky. Well, I look forward to working with Mr.
Burr and all of the Republicans to try and improve the
enforcement mechanisms so that we preserve the rights of
consumers.
Let me just say that my experience in the State legislature
with the Department of Professional Regulation, which was
designed to be the watchdog group,--I don't have any experience
with optometrists--that there were precious few situations
where any physician was penalized in any way, even after
repeated violations.
Mr. Hubbard. Well, that was a very large topic in the
litigation. Yes, there are precious few of that. As Dr.
Cummings mentioned, in many boards, the optometrists largely
run the boards. I'm proud to say that that is not the case in
New York.
But in any case, yes, it's sometimes difficult to place the
enforcement authority in that board that has membership by the
members of the profession and less interest in the interest of
the consumers.
Ms. Schakowsky. Let me, finally, say for the record as a
contact lens wearer, I am also, as Representative Shimkus is,
very good friends with my optometrist, who has done a wonderful
job. I wanted to have that on the record.
Mr. Stearns. Thank the gentlelady.
Mr. Terry?
Mr. Terry. I'll have to get one of those sometime. I mean
optometrists, not a friend. I just go to whoever is available.
And maybe that is part of the issue with a lot of the consumers
out there.
Mr. Hubbard, I am just curious. You said there were 32
States that joined with New York in the litigation. Was
Nebraska one of those States? As I understand----
Mr. Hubbard. No.
Mr. Terry. That doesn't surprise me. The reason why that
struck me is I reviewed the half a dozen e-mails or letters
that I have received on this prior to coming here to this
hearing. And I did receive an e-mail from a Jane Ellsworth, who
said she has got two homes, Omaha, Nebraska and South Carolina,
and she can't get her prescription filled by 1-800, by the way,
in the e-mail, but she can in South Carolina. But then I
understand that Nebraska is one of the States that has a
mandatory release but no verification.
So we scripted it into the law, inscribed in the law that
doctors have no penalty for not releasing, which I think the
argument here or the discussion here has really evolved passive
versus active to really how do you enforce this, as Ms.
Schakowsky had brought up.
I am really curious about the Texas example here. Ms.
Venable, we have had a discussion here about thousands of
complaints. I think you in your statement said there have been
zero eye physicians, optometrists that have been called on
this. We're hearing from the testimony that may be because they
are self-governing and self-policing.
What is your view of the situation? You're the one on the
front lines in Texas. Tell us who is right and wrong in this
process.
Ms. Venable. Well, thank you for the opportunity. I feel
strongly that this--first let me say that the Texas Board of
Optometry said that they do not have the manpower to deal with
all of the complaints that they have received. And, yet, it
seems that simply sending a letter to a consumer who has filed
a complaint asking for more information is their assumed
handling of that complaint. I have not spoken to a single
consumer who feels like their complaint has been handled.
Mr. Terry. Are you aware of any situations in Texas, like
Dr. Cummings has suggested, where the State board did follow
through?
Ms. Venable. I am aware of no situation where not only a
consumer got relief or any optometrist was sanctioned in any
way by virtue of failing to verify a prescription. That's why I
guess inherent in this whole problem is the fact that
optometrists alone are the both eye care provider and retailer.
One would say, ``Could there be relief in the optometrists
serving only as the eye care provider and not being able to be
the retailer?'' We wouldn't necessarily be supporting that
because it would still limit that consumer's opportunity to
purchase their contact lens from that optometrist. But at some
point, that could be the only true remedy for consumers to have
choice in Texas.
Mr. Terry. All right. Dr. Cummings, on behalf of the AOA,
let's talk about what we mean by enforcement. Now, you said you
were open to penalties. Is it a paper tiger penalty that the
AOA is in favor of or is there some what I would call real
enforcement, maybe under the Illinois model, where you have a
separate entity that looks after it, the State attorneys
general? Would you agree to that, to allow the State attorneys
general to investigate private right of remedy?
Mr. Cummings. Of course. I think in this particular
language that we have now in 2221, that it's a 10 or 11
thousand-dollar penalty at this point for not releasing the
contact lens prescription or verifying the contact lens
prescription. To me, that seems like a lot of money.
And I'm sure that that would get the attention of most
providers out there. And I don't think it would take too many
of those penalties to bring in what outliers may be out there
in line.
On the other hand, I also think that one of the things that
needs to be looked at when you talk about enforcement is that
for especially the Internet companies that don't make any
attempt at all to verify their contact lenses and dispense
contact lenses without prescriptions, that the FDA regulations
and laws that already apply to that particular issue, that the
FDA be encouraged to follow through and prosecute those folks
that are doing that piece so that you are covering both sides.
You know, if $11,000 doesn't seem to be the magic number, I
mean, we are certainly open to whatever that number is. And as
Mr.----
Mr. Terry. How about private right of remedy?
Mr. Cummings. And, as Mr. Hubbard said, certainly there are
going to be a few consumers in that process that would get
caught while you work through that process. But I do not
believe with those kinds of penalties and sanctions and also
the possibility of losing your license, that it would take too
long to work through that process.
Mr. Terry. Thank you.
Mr. Stearns. The author of the bill, Mr. Burr?
Mr. Burr. Thank you, Mr. Chairman. I forgot earlier to ask
unanimous consent that my opening statement be included in the
record.
Mr. Stearns. By unanimous consent, so ordered.
Mr. Burr. I thank the gentleman.
Ms. Venable, let me just say I heard your comments as it
related to patients in Texas who didn't feel like they had
necessarily been heard or that their complaints had been acted
on. Let me suggest to my colleagues if they question whether
this is a problem, this is one of six stacks of postcards that
I have received in the last year relative to individuals who
feel this is important to them.
This is not an attempt to run optometrists out of business.
I mean, to some degree, I am amazed at the level of fight that
there is on what I think is a real simple piece of legislation.
It's one that says let's let patients decide. You look at their
eyes. You determine what their needs are.
You know, I went to the dentist yesterday morning. They
made an appointment for me 6 months from now, I think. Chances
are I'll probably change it three or four times. But I get to
make that decision. The dentist would probably love to see me
every 3 months, but I'm the one who pays. And I get to choose
which dentist. I get to shop to some degree. And I base it upon
what it costs and the service that's performed.
That's all we're talking about here. We're letting
individuals who need contact lenses. I happen to use one of
them. I don't need two. I haven't quite figured that out. I
wouldn't have figured it out by myself. It was my optometrist
who figured it out. But by the same token, I would like to buy
the one at the least expensive place that I can.
And I'm not sure from the standpoint of optometrists what
makes you think you have the right to sell what you prescribe.
We have a history up here started with Congressman Pete Stark
that when we solve problems that cost the system too much
money, we begin to make some rules and regulations that I don't
always agree with. And I have tried to change some of them.
Let me just sort of send a shot across the bow that in the
absence of us trying to find a way to work together, this is
where we end up. And we're not always quick to go back and fix
some of our mistakes.
Let me ask Mr. Beales. If this legislation were amended to
include passive verification, is there a need then to increase
the enforcement mechanism in this bill, do you think?
Mr. Beales. Well, I think passive verification is much
easier to enforce because it is in many respects self-
enforcing. The place where we would need to focus our
enforcement efforts would be on the providers to make sure that
they were seeking the passive verification, but that's a
relatively small number of people, as opposed to having to
visit each potential eye care provider to see whether, in fact,
they're responding to verifications. It would be a much simpler
problem.
Mr. Burr. And if I remember correctly--and somebody correct
me if I am wrong--currently to fill or to sell a contact lens
without a prescription exposes somebody to a significant fine.
Am I correct? Does anybody object to that?
Mr. Hubbard. No. That's true.
Mr. Burr. Is that true, Dr. Cummings?
Mr. Cummings. Yes.
Mr. Burr. So only somebody with the intent of deceiving
most of the time would expose themselves to that fine?
Mr. Hubbard. Unfortunately, the mechanism's in place to
impose that fine. But it's never been acted upon. The FDA has
not acted upon fining people for doing that. But it is there.
Mr. Burr. And do you know that the offer was made to
strengthen it in this legislation? An optometrist declined the
offer, which really makes me as the author of the bill if
everybody's intent is to actually focus on the patients to
solve some of the problems that we are dealing with. They may
not be yours. They're somebody's. They happened to have found
their way to my office.
That's what we're supposed to respond to, people who feel
that they have a problem. I don't think there's any question we
can do it better than we do it today.
Mr. Chairman, I thank you for holding this hearing. I thank
all of my colleagues for their indulgence. But I also encourage
you that now is a good time that we ask Chairman Tauzin to mark
this legislation up or for you to mark it up and then for us to
mark it up in full committee. And I assure the Chair that he
will have my full support as we try to do that. And I yield
back.
Mr. Stearns. And I thank the gentleman and for his cogent
bill here. I think the hearing has brought out that there is a
lot of support and need for this type of bill.
I would conclude by just asking Dr. Cummings, if we
included in this bill a passive standard verification, would
you support the bill?
Mr. Cummings. I don't think that a passive verification is
something that we could totally support.
Mr. Stearns. So you are saying unequivocally you could not
support it? I mean, is there a way we could tweak this with a
passive verification that would make it acceptable to you?
Mr. Cummings. I think there is always room to look at
options and try and work out something that is acceptable to
us, but a--and we would be more than willing to sit down and
work with you.
Mr. Stearns. I appreciate your help here. We certainly want
to reach out to get professional people like yourself involved
and not move without your feedback.
So we appreciate all of our witnesses today for coming. And
with that, the subcommittee is adjourned.
[Whereupon, at 2:45 p.m., the hearing was adjourned.]
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