)Contact Lens Rule Modernization Act | Timeline | Overview | Status of S. 4613 | Why S. 4613 benefits optometrists | Why the FCLCA exists | How the FCLCA keeps retailers in check | Lens.com’s stance | FCLCA summary and full text
Is the contact lens industry taking a step back?
In September 2020, Sen. John Boozman (R-AR) introduced in the United States Senate the Contact Lens Rule Modernization Act (S. 4613). The bill is co-sponsored by Sens. Roger Wicker (R-MS), Jim Inhofe (R-OK), and Rand Paul (R-KY).
The bill seeks to thwart an update to the Contact Lens Rule in 2020 that the Federal Trade Commission (FTC) unanimously approved. The update, which went into effect on Oct. 16, 2020, requires optometrists to obtain signed acknowledgment forms from patients that indicate they have received a copy of their contact lens prescription. According to proponents of the bill, the act of having patients sign acknowledgment forms, whether paper or digital, may cost each optometrist at least $18,000 per year.
Many optometrists have vigorously fought the FTC rule changes, arguing that the changes unfairly target them, their patients, their staff, and their communities. Optometrists also argued that the FTC rule changes place an undue burden on them while doing little to keep online contact lens retailers in check.
Such pushback from optometrists has prompted online contact lens retailers in the United States to ask consumers to urge their senators to vote against the bill. Those efforts worked, and the bill did not even make it through its markup. A markup session is when a senate subcommittee or committee considers a bill and either accepts or rejects it. If accepted, the bill proceeds to the next stage of the legislative process. If rejected, it expires.
Timeline of the Fight for Consumer Rights in the Contact Lens Industry
The contact lens industry has come a long way in terms of consumer rights. In the years following the introduction of soft contacts, consumers had no choice but to purchase contacts from their prescribers. That changed when online retailers entered the market in the 90s, offering consumers an alternative to their prescribers.
However, contact lenses were considered medical devices. This meant that authorities had to find a way to strike a balance between allowing consumers to shop around and making sure that they do so safely. This eventually resulted in the passing of the Fairness to Contact Lens Consumers Act (FCLCA), which gave consumers certain rights, including the right to shop around when buying contact lenses.
For your reference, here’s a timeline of the fight for consumer rights in the contact lens industry:
- July 26, 2001: Rep. Fortney Pete Stark (D-CA-13) introduced the Contact Lens Prescription Release Act (H.R. 2663) in the House. This bill precedes what would later become the FCLCA.
- May 22, 2003: Rep. Richard Burr (R-NC-5) introduced the FCLCA (H.R. 2221) in the House.
- September 23, 2003: Burr introduced an updated draft of the FCLCA (H.R. 3140) in the House. The updated bill gives consumers certain rights, including the right to shop around when buying contact lenses. It also imposes duties on contact lens prescribers and sellers, and requires the FTC to develop and enforce implementing rules.
- November 19, 2003: The FCLCA was passed/agreed to in the House.
- November 20, 2003: The FCLCA was passed/agreed to without amendment by Unanimous Consent in the Senate.
- December 6, 2003: The FCLCA was signed by the president and became Public Law No: 108-164.
- February 4, 2004: The FCLCA went into effect.
- July 2, 2004: The FTC issued the Contact Lens Rule. The Rule requires prescribers to give patients a copy of their contact lens prescriptions at the end of a contact lens fitting, even if the patient doesn’t ask for it.
- September 20, 2006: Rep. Ed Whitfield (R-KY-1) introduced the Contact Lens Consumer Health Protection Act (H.R. 6117) in the House. The bill amends the FCLCA to require the seller to provide the prescriber with a toll-free telephone number and email address for questions relating to a contact lens prescription verification request.
- April 11, 2016: Sen. Bill Cassidy (R-LA) introduced the Contact Lens Consumer Health Protection Act of 2016 (S. 2777) in the Senate. The bill amends the FCLCA to require contact lens sellers to provide a toll-free telephone number and email address that prescribers can use to ask questions about a seller’s prescription verification request.
- September 22, 2016: Rep. Pete Olson (R-TX-22) introduced the Contact Lens Consumer Health Protection Act of 2016 (H.R. 6157) in the House. The bill is identical to S. 2777.
- August 17, 2020: The FTC amended the Contact Lens Rule to require prescribing eye care practitioners to obtain a confirmation of prescription release from patients after releasing a contact lens prescription and maintain each such acknowledgment for a period of not less than three years.
- September 17, 2020: Sen. John Boozman (R-AR) introduced the Contact Lens Rule Modernization Act in the House.
- October 16, 2020: The amended Contact Lens Rule went into effect.
An Overview of S. 4613
Sponsors of S. 4613 claim that the bill seeks to alleviate patient safety concerns by requiring optometrists to post “conspicuous” signage in their offices notifying patients of their right to a copy of their contact lens prescription. The bill also prohibits optometrists from requiring patients to sign acknowledgment forms and prohibits automated telephone calls to verify a prescription.
Boozman, an optometrist by trade, said the FTC simply missed the mark when it wrote the Contact Lens Rule. Rather than protect patients, the rule puts patient safety at risk and creates undue burdens on practices, he added.
Where is S. 4613 now?
Since its introduction, the bill has been read twice and referred to the Committee on Commerce, Science, and Transportation, where Wicker is a ranking member. There has been no update since, so you can rest assured that your rights as a consumer are still secure.
For your convenience and peace of mind, we will update this post in six months or when S. 4613 proceeds to the next stage of the legislative process, whichever comes sooner.
Why S. 4613 benefits optometrists, not patients
Proponents of S. 4613 claim that the bill will alleviate patient safety concerns. However, only optometrists, Boozman included, would actually benefit from bills like this, not patients. That’s because optometrists have an inherent conflict of interest, which is that they sell what they prescribe.
If optometrists are not required by law to release contact lens prescriptions to their patients automatically, they give their patients little to no choice but to buy contact lenses from them. This conflict of interest is exactly why legislators passed the FCLCA, which many optometrists continue to ignore. We discuss the FCLCA in more detail in the next section.
Proponents of S. 4613 also claim that the bill protects patients by prohibiting automated telephone calls, dubbed “robocalls,” to verify a patient’s contact lens prescription. Many optometrists argue that receiving such calls from online contact lens retailers isn’t useful or that the calls themselves are hard to understand. Others also say that robocalls jeopardize patients’ vision health, but that could not be further from the truth. Reputable online contact lens retailers, Lens.com included, use state-of-the-art tech and employ professional customer service associates to safely and efficiently verify customers’ prescriptions.
Why does the FCLCA exist?
The FCLCA was introduced in 2003 to organize the way in which contact lenses were dispensed and by whom. Its initial intent was to improve the level of protection for consumers.
The FCLCA also requires optometrists to release prescriptions to patients automatically after a fitting. That way, patients are free to get their contacts from an online retailer of their choice. S. 4613 would have ended a patient’s guarantee that they receive a copy of their prescription, even if they don’t ask for it. Additionally, the FCLCA requires contact lens retailers to verify the validity of prescriptions before releasing contacts to consumers.
As part of the FCLCA, the FTC was given the power to enforce these rules on both prescribers and sellers of contacts. S. 4613 would have stripped the FTC of its power to enforce the FCLCA. Without enforcement, optometrists would be free to ignore the law and withhold prescriptions to try to force their patients to purchase contacts from them.
Today, many anti-consumer optometrist associations continue to oppose the FCLCA. It’s worth noting that many of these associations, like the American Optometric Association (AOA), are backed by contact lens manufacturers that stand to profit from optometrists forcing patients to buy the very contacts they prescribe by withholding prescriptions.
How the FTC uses the FCLCA to keep retailers in check
Optometrist associations claim that the FTC does little to curb online contact lens retailers’ violations of the FCLCA, unfairly favoring them over optometrists. This is simply not true.
Early this year, the FTC, along with the Department of Justice (DoJ), announced that the government will collect $1.5 million in civil penalties and $2 million in consumer redress from Hubble Contacts. These fines are part of a settlement to resolve allegations that Hubble Contacts violated the FCLCA and the Contact Lens Rule.
In the complaint filed in the U.S. District Court for the District of Columbia, the government alleged that Hubble Contacts sold contact lenses online without verifying customers’ prescriptions. The complaint also charged Hubble Contacts with substituting its own brand of contacts for those prescribed by optometrists and procuring what it falsely portrayed as independent reviews of its products.
According to a press release from the DoJ, the court order requires Hubble Contacts to:
- refrain from altering prescriptions to change the brand prescribed,
- verify the prescription for contact lens orders submitted without a written prescription,
- cease other deceptive practices, and
- satisfy ongoing recordkeeping, certification, and compliance obligations.
In the FTC’s own press release, Samuel Levine, director of the commission’s Bureau of Consumer Protection, said that Hubble Contacts created needless risk for its customers’ vision health. “Today’s action makes clear that firms will pay a price for deceiving their customers, flouting the Contact Lens Rule, and using misleading reviews,” Levine added.
Lens.com supports consumers’ rights
At Lens.com, many of our customers continue to report issues with getting a copy of their prescription from their optometrist. Such issues make it difficult for our customers to access the products they need, when they need them, and at a price they deserve.
We cannot let the optometry industry turn back the clock on the enforcement of consumer protections. Lens.com is one of a number of online retailers to submit formal opinions to U.S. legislators to aid them in crafting the FCLCA. As such, you can rest assured that we will let you know the next time the AOA or anyone else tries to get a bill passed to rob you of your rights as a consumer.
Summary & Full Text of the FCLCA
For your reference and convenience, we’ve included the full text of H.R. 3140, or the FCLCA. We’ve also included a summary of the Act, as it can tricky to make sense of on the internet.
Summary – Public Law 108–164 (Date Approved: 12/06/2003)
(Sec. 2) Requires a contact lens prescriber (a person permitted under State law to issue prescriptions for contact lenses) to provide a patient with a copy of their contact lens prescription, whether or not requested by the patient, and verify the prescription’s accuracy, or make necessary corrections, to a contact lens seller or any person designated by the patient. Prohibits a prescriber from: (1) requiring patients to purchase contact lenses from the prescriber; (2) charging an additional fee for a copy of the prescription; (3) requiring the patient to sign a waiver; and (4) disclaiming liability or responsibility for the accuracy of the eye examination.
(Sec. 3) Allows a prescriber to withhold the contact lens prescription until the prescriber receives payment or proof of insurance coverage only if the prescriber also requires immediate payment from a patient not needing any ophthalmic goods.
(Sec. 4) Allows a seller to fill a prescription for contact lenses only when: (1) a seller receives a contact lens prescription directly or by facsimile; (2) a seller verifies a prescription by direct communication with the prescriber; or (3) the prescriber fails to respond to the seller within eight business hours after being contacted by the seller with the prescription information. Requires a seller to maintain a record of all such communication with a patient or a prescriber.
(Sec. 5) Declares that a contact lens prescription shall expire on the date specified by the law of the State in which it is written, but not less than one year after the issue date of the prescription. Permits an exception for a patient’s ocular health.
(Sec. 6) Prohibits advertising that represents that contact lenses may be obtained without a prescription.
(Sec. 8) Requires the Federal Trade Commission (FTC) to prescribe rules to carry out this Act.
(Sec. 9) States that any violation of this Act shall be treated as a violation of the Federal Trade Commission Act regarding unfair or deceptive acts or practices.
(Sec. 10) Requires the FTC to report to Congress on: (1) exclusive relationships between prescribers or sellers and contact lens manufacturers and the impact such relationships have on competition; (2) differences between online and off-line [sic] sellers of contact lenses; (3) contact lens prescriptions that specify brand name and their impact on competition; (4) the FTC eyeglasses rule, its enforcement, and its impact on competition; and (5) any other issue that affects competition in the sale of contact lenses.
Full Text of H.R. 3140 — 108th Congress (2003-2004)
[108th Congress Public Law 164]
[From the U.S. Government Printing Office]
[DOCID: f:publ164.108]
[[Page 2024]]
FAIRNESS TO CONTACT LENS CONSUMERS ACT
[[Page 117 STAT. 2025]]
Public Law 108-164
108th Congress
An Act
To provide for availability of contact lens prescriptions to patients,
and for other purposes. <<NOTE: Dec. 6, 2003 - [H.R. 3140]>>
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled, <<NOTE: Fairness to
Contact Lens Consumers Act.>>
SECTION 1. <<NOTE: 15 USC 7601 note.>> SHORT TITLE.
This Act may be cited as the ``Fairness to Contact Lens Consumers
Act''.
SEC. 2. <<NOTE: 15 USC 7601.>> AVAILABILITY OF CONTACT LENS
PRESCRIPTIONS TO PATIENTS.
(a) In General.--When a prescriber completes a contact lens fitting,
the prescriber--
(1) whether or not requested by the patient, shall provide
to the patient a copy of the contact lens prescription; and
(2) shall, as directed by any person designated to act on
behalf of the patient, provide or verify the contact lens
prescription by electronic or other means.
(b) Limitations.--A prescriber may not--
(1) require purchase of contact lenses from the prescriber
or from another person as a condition of providing a copy of a
prescription under subsection (a)(1) or (a)(2) or verification
of a prescription under subsection (a)(2);
(2) require payment in addition to, or as part of, the fee
for an eye examination, fitting, and evaluation as a condition
of providing a copy of a prescription under subsection (a)(1) or
(a)(2) or verification of a prescription under subsection
(a)(2); or
(3) require the patient to sign a waiver or release as a
condition of verifying or releasing a prescription.
SEC. 3. <<NOTE: 15 USC 7602.>> IMMEDIATE PAYMENT OF FEES IN LIMITED
CIRCUMSTANCES.
A prescriber may require payment of fees for an eye examination,
fitting, and evaluation before the release of a contact lens
prescription, but only if the prescriber requires immediate payment in
the case of an examination that reveals no requirement for ophthalmic
goods. For purposes of the preceding sentence, presentation of proof of
insurance coverage for that service shall be deemed to be a payment.
SEC. 4. <<NOTE: 15 USC 7603.>> PRESCRIBER VERIFICATION.
(a) Prescription Requirement.--A seller may sell contact lenses only
in accordance with a contact lens prescription for the patient that is--
[[Page 117 STAT. 2026]]
(1) presented to the seller by the patient or prescriber
directly or by facsimile; or
(2) verified by direct communication.
(b) Record Requirement.--A seller shall maintain a record of all
direct communications referred to in subsection (a).
(c) Information.--When seeking verification of a contact lens
prescription, a seller shall provide the prescriber with the following
information:
(1) Patient's full name and address.
(2) Contact lens power, manufacturer, base curve or
appropriate designation, and diameter when appropriate.
(3) Quantity of lenses ordered.
(4) Date of patient request.
(5) Date and time of verification request.
(6) Name of contact person at seller's company, including
facsimile and telephone number.
(d) Verification Events.--A prescription is verified under this Act
only if one of the following occurs:
(1) The prescriber confirms the prescription is accurate by
direct communication with the seller.
(2) The prescriber informs the seller that the prescription
is inaccurate and provides the accurate prescription.
(3) The prescriber fails to communicate with the seller
within 8 business hours, or a similar time as defined by the
Federal Trade Commission, after receiving from the seller the
information described in subsection (c).
(e) Invalid Prescription.--If a prescriber informs a seller before
the deadline under subsection (d)(3) that the contact lens prescription
is inaccurate, expired, or otherwise invalid, the seller shall not fill
the prescription. The prescriber shall specify the basis for the
inaccuracy or invalidity of the prescription. If the prescription
communicated by the seller to the prescriber is inaccurate, the
prescriber shall correct it.
(f) No Alteration.--A seller may not alter a contact lens
prescription. Notwithstanding the preceding sentence, if the same
contact lens is manufactured by the same company and sold under multiple
labels to individual providers, the seller may fill the prescription
with a contact lens manufactured by that company under another label.
(g) Direct Communication.--As used in this section, the term
``direct communication'' includes communication by telephone, facsimile,
or electronic mail.
SEC. 5. <<NOTE: 15 USC 7604.>> EXPIRATION OF CONTACT LENS PRESCRIPTIONS.
(a) In General.--A contact lens prescription shall expire--
(1) on the date specified by the law of the State in which
the prescription was written, if that date is one year or more
after the issue date of the prescription;
(2) not less than one year after the issue date of the
prescription if such State law specifies no date or a date that
is less than one year after the issue date of the prescription;
or
(3) notwithstanding paragraphs (1) and (2), on the date
specified by the prescriber, if that date is based on the
medical judgment of the prescriber with respect to the ocular
health of the patient.
[[Page 117 STAT. 2027]]
(b) Special Rules for Prescriptions of Less Than 1 Year.--If a
prescription expires in less than 1 year, the reasons for the judgment
referred to in subsection (a)(3) shall be documented in the patient's
medical record. In no circumstance shall the prescription expiration
date be less than the period of time recommended by the prescriber for a
reexamination of the patient that is medically necessary.
(c) Definition.--As used in this section, the term ``issue date''
means the date on which the patient receives a copy of the prescription.
SEC. 6. <<NOTE: 15 USC 7605.>> CONTENT OF ADVERTISEMENTS AND OTHER
REPRESENTATIONS.
Any person that engages in the manufacture, processing, assembly,
sale, offering for sale, or distribution of contact lenses may not
represent, by advertisement, sales presentation, or otherwise, that
contact lenses may be obtained without a prescription.
SEC. 7. <<NOTE: 15 USC 7606.>> PROHIBITION OF CERTAIN WAIVERS.
A prescriber may not place on the prescription, or require the
patient to sign, or deliver to the patient a form or notice waiving or
disclaiming the liability or responsibility of the prescriber for the
accuracy of the eye examination. The preceding sentence does not impose
liability on a prescriber for the ophthalmic goods and services
dispensed by another seller pursuant to the prescriber's correctly
verified prescription.
SEC. 8. <<NOTE: 15 USC 7607.>> RULEMAKING BY FEDERAL TRADE COMMISSION.
The Federal Trade Commission shall prescribe rules pursuant to
section 18 of the Federal Trade Commission Act (15 U.S.C. 57a) to carry
out this Act. Rules so prescribed shall be exempt from the requirements
of the Magnuson-Moss Warranty--Federal Trade Commission Improvement Act
(15 U.S.C. 2301 et seq.). Any such regulations shall be issued in
accordance with section 553 of title 5, United States
Code. <<NOTE: Deadline.>> The first rules under this section shall take
effect not later than 180 days after the effective date of this Act.
SEC. 9. <<NOTE: 15 USC 7608.>> VIOLATIONS.
(a) In General.--Any violation of this Act or the rules required
under section 8 shall be treated as a violation of a rule under section
18 of the Federal Trade Commission Act (15 U.S.C. 57a) regarding unfair
or deceptive acts or practices.
(b) Actions by the Commission.--The Federal Trade Commission shall
enforce this Act in the same manner, by the same means, and with the
same jurisdiction, powers, and duties as though all applicable terms and
provisions of the Federal Trade Commission Act (15 U.S.C. 41 et seq.)
were incorporated into and made a part of this Act.
SEC. 10. <<NOTE: 15 USC 7609.>> STUDY AND REPORT.
(a) Study.--The Federal Trade Commission shall undertake a study to
examine the strength of competition in the sale of prescription contact
lenses. The study shall include an examination of the following issues:
(1) Incidence of exclusive relationships between prescribers
or sellers and contact lens manufacturers and the impact of such
relationships on competition.
[[Page 117 STAT. 2028]]
(2) Difference between online and offline sellers of contact
lenses, including price, access, and availability.
(3) Incidence, if any, of contact lens prescriptions that
specify brand name or custom labeled contact lenses, the reasons
for the incidence, and the effect on consumers and competition.
(4) The impact of the Federal Trade Commission eyeglasses
rule (16 CFR 456 et seq.) on competition, the nature of the
enforcement of the rule, and how such enforcement has impacted
competition.
(5) Any other issue that has an impact on competition in the
sale of prescription contact lenses.
(b) <<NOTE: Deadline.>> Report.--Not later than 12 months after the
effective date of this Act, the Chairman of the Federal Trade Commission
shall submit to the Congress a report of the study required by
subsection (a).
SEC. 11. <<NOTE: 15 USC 7610.>> DEFINITIONS.
As used in this Act:
(1) Contact lens fitting.--The term ``contact lens fitting''
means the process that begins after the initial eye examination
and ends when a successful fit has been achieved or, in the case
of a renewal prescription, ends when the prescriber determines
that no change in prescription is required, and such term may
include--
(A) an examination to determine lens specifications;
(B) except in the case of a renewal of a
prescription, an initial evaluation of the fit of the
lens on the eye; and
(C) medically necessary follow up examinations.
(2) Prescriber.--The term ``prescriber'' means, with respect
to contact lens prescriptions, an ophthalmologist, optometrist,
or other person permitted under State law to issue prescriptions
for contact lenses in compliance with any applicable
requirements established by the Food and Drug Administration.
(3) Contact lens prescription.--The term ``contact lens
prescription'' means a prescription, issued in accordance with
State and Federal law, that contains sufficient information for
the complete and accurate filling of a prescription, including
the following:
(A) Name of the patient.
(B) Date of examination.
(C) Issue date and expiration date of prescription.
(D) Name, postal address, telephone number, and
facsimile telephone number of prescriber.
(E) Power, material or manufacturer or both.
(F) Base curve or appropriate designation.
(G) Diameter, when appropriate.
(H) In the case of a private label contact lens,
name of manufacturer, trade name of private label brand,
and, if applicable, trade name of equivalent brand name.
[[Page 117 STAT. 2029]]
SEC. 12. <<NOTE: 15 USC 7601 note.>> EFFECTIVE DATE.
This Act shall take effect 60 days after the date of the enactment
of this Act.
Approved December 6, 2003.
LEGISLATIVE HISTORY--H.R. 3140:
---------------------------------------------------------------------------
HOUSE REPORTS: No. 108-318 (Comm. on Energy and Commerce).
CONGRESSIONAL RECORD, Vol. 149 (2003):
Nov. 19, considered and passed House.
Nov. 20, considered and passed Senate.
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