Title 16—Commercial Practices--Volume 1
PART 456—OPHTHALMIC PRACTICE RULES (EYEGLASS RULE)
§ 456.1   Definitions.
(a) A patient is any person who has had a refractive eye examination.
(b) A refractive eye examination is the process of determining the refractive condition of a person's eyes or the presence of any visual anomaly by the use of objective or subjective tests.
(c) Ophthalmic goods are eyeglasses, or any component of eyeglasses, and contact lenses.
(d) Ophthalmic services are the measuring, fitting, and adjusting of ophthalmic goods subsequent to a refractive eye examination.
(e) An ophthalmologist is any Doctor of Medicine or Osteopathy who performs refractive eye examinations.
(f) An optometrist is any Doctor of Optometry.
(g) A prescription is the written specifications for lenses for eyeglasses which are derived from a refractive eye examination, including all of the information specified by State law, if any, necessary to obtain lenses for eyeglasses.
§ 456.2   Separation of examination and dispensing.
It is an unfair act or practice for an ophthalmologist or optometrist to:
(a)(1) Fail to provide to the patient one copy of the patient's prescription immediately after the refractive eye examination is completed and before offering to sell the patient ophthalmic goods, whether or not the prescription is requested by the patient. Such prescription shall be provided:
(i) On paper; or
(ii) In a digital format that can be accessed, downloaded, and printed by the patient, after obtaining verifiable affirmative consent, pursuant to § 456.3.
(2) Provided: An ophthalmologist or optometrist may refuse to give the patient a copy of the patient's prescription until the patient has paid for the refractive eye examination, but only if that ophthalmologist or optometrist would have required immediate payment from that patient had the examination revealed that no ophthalmic goods were required. For purposes of the preceding sentence, the presentation of proof of insurance coverage for that service shall be deemed to be a payment;
(b) Condition the availability of a refractive eye examination to any person on a requirement that the patient agree to purchase any ophthalmic goods from the ophthalmologist or optometrist;
(c) Charge the patient any fee in addition to the ophthalmologist's or optometrist's refractive eye examination fee as a condition to releasing the prescription to the patient. Provided: An ophthalmologist or optometrist may charge an additional fee for verifying ophthalmic goods dispensed by another seller when the additional fee is imposed at the time the verification is performed; or
(d) 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 ophthalmologist or optometrist for the accuracy of the refractive eye examination or the accuracy of the ophthalmic goods and services dispensed by another seller.
§ 456.3   Verifiable affirmative consent to providing the prescription in a digital format.
For a prescription copy provided in a digital format, the prescriber shall:
(a) Identify to the patient the specific method or methods of electronic delivery that will be used, such as text message, electronic mail, or an online patient portal;
(b) Obtain, on paper or in a digital format, the patient's verifiable affirmative consent to receive a digital copy through the identified method or methods; and
(c) Maintain records or evidence of a patient's affirmative consent for a period of not less than three years. Such records or evidence shall be available for inspection by the Federal Trade Commission, its employees, and its representatives.
§ 456.4   Confirmation of prescription release.
(a)(1) Upon completion of a refractive eye examination, and after providing a copy of the prescription to the patient, the prescriber shall do one of the following:
(i) If a paper copy of the prescription was provided to the patient, request that the patient acknowledge receipt of the prescription by signing a separate statement on paper or in a digital format confirming receipt of the prescription; or
(ii) If a digital copy of the prescription was provided to the patient (via methods including an online portal, electronic mail, or text message, and pursuant to § 456.3), retain evidence that such prescription was sent, received, or made accessible, downloadable, and printable.
(2) If the prescriber elects to confirm prescription release via paragraph (a)(1)(i) of this section, the prescriber may, but is not required to, use the statement, “My eye care professional provided me with a copy of my prescription at the completion of my examination” to satisfy the requirement.
(3) In the event the patient declines to sign a confirmation requested under paragraph (a)(1)(i) of this section, the prescriber shall note the patient's refusal on the document and sign it.
(b) A prescriber shall maintain the records or evidence required under paragraph (a) of this section for a period of not less than three years. Such records or evidence shall be available for inspection by the Federal Trade Commission, its employees, and its representatives.
(c) Paragraphs (a) and (b) of this section shall not apply to prescribers who do not have a direct or indirect financial interest in the sale of eye wear, including, but not limited to, through an association, affiliation, or co-location with an optical dispenser.
§ 456.5   Federal or State employees.
This rule does not apply to ophthalmologists or optometrists employed by any Federal, State or local government entity.
§ 456.6   Declaration of Commission Intent.
In prohibiting the use of waivers and disclaimers of liability in § 456.2(d), it is not the Commission's intent to impose liability on an ophthalmologist or optometrist for the ophthalmic goods and services dispensed by another seller pursuant to the ophthalmologist's or optometrist's prescription.
§ 456.7   Rules applicable to prescriptions for contact lenses and related issues.
Rules applicable to prescriptions for contact lenses and related issues may be found at 16 CFR part 315 (Contact Lens Rule).