Mandatory CL Release Law

[Foveator]

The federal government is fast tracking a mandatory CL release law that will require the release of a valid CL Rx at the end of every CL fitting, with a $10,000 fine for those who "forget" to release the Rx. Some info is here:

http://biz.yahoo.com/rc/031001/health_contacts_1.html

The proposed text is as follows (but may have been somewhat ammeded over the past few weeks): ===========================================

The Bill is H.R. 2221, and here it is as of 10/3/2003:

108th CONGRESS

1st Session

H. R. 2221
To provide for availability of contact lens prescriptions to patients,
and for other purposes.

IN THE HOUSE OF REPRESENTATIVES

May 22, 2003
Mr. BURR (for himself, Mr. TAUZIN, Mr. SENSENBRENNER, and Mr. MATHESON) introduced the following bill; which was referred to the Committee on Energy and Commerce

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A BILL
To provide for availability of contact lens prescriptions to patients,
and for other purposes.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

This Act may be cited as the `Fairness to Contact Lens Consumers Act'.

SEC. 2. AVAILABILITY OF CONTACT LENS PRESCRIPTIONS TO PATIENTS.

(a) IN GENERAL- Upon completion of a contact lens fitting, a
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 or verification of a prescription under subsection (a);

(2) require payment in addition to the examination fee as a condition of providing a copy of a prescription or verification of a prescription under subsection (a); or

(3) require the patient to sign a waiver or release as a condition of verifying or releasing a prescription.

SEC. 3. EXPIRATION OF CONTACT LENS PRESCRIPTIONS.

A contact lens prescription shall expire--

(1) on the date specified by the law of the State involved, 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.

SEC. 4. 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. 5. 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.

SEC. 6. VIOLATIONS.

Any violation of this Act 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.

SEC. 7. 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) The States that have laws that require active or passive
verification for the sale of contact lenses.

(2) With respect to the States that require active verification, the
practices of prescribers in complying with State law, the effect of
noncompliance, and the harm to competition and consumers that results from noncompliance.

(3) With respect to the States that require active verification, the
level of enforcement and any problems relating to enforcement.

(4) The impact on competition of verification standards adopted by retail sellers of prescription contact lenses.

(5) With respect to States that require passive verification or have no applicable verification laws, the possible effect of such laws or lack thereof on the ocular health of patients. In addition, the effect of such laws or lack thereof on compliance by sellers in confirming valid contact lens prescriptions, including expiration dates. The Commission shall consult the Food and Drug Administration on this particular issue.

(6) The 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.

(7) Any other issue that has an impact on competition in the sale of prescription contact lenses.

(b) REPORT- Not later than 9 months after the date of the enactment 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. 8. 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 the prescriber is satisfied that 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 followup 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 the specifications necessary for a patient to obtain contact lenses and may include such items as the following:

(A) The name of the patient.

(B) The date of the examination.

(C) The issue date and the expiration date of the prescription.

(D) A clear notation contact lenses are suitable for the patient.

(E) The parameters and instructions that are necessary for manufacture and duplication of the lenses.

(F) The name, postal address, telephone number, and facsimile telephone number of the prescriber.

(G) The expiration date of the prescription.

SEC. 9. EFFECTIVE DATE.

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

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It's interesting to note that a fitter who violates the rule can be fined up to $10,000, yet a distributer/dispenser who ignores the rule and fills an order without a valid Rx, also in violation of the law, will not.

If you fit an RGP that takes a few set of lenses, when you get to what you consider the final Rx, you must give the patient an Rx and let him decide if you or another entity should fill the Rx.

UPDATE: The newest version of this bill is at this link:

http://energycommerce.house.gov/108/...03/3140sub.pdf