2019 -- S 0293

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LC001437

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     STATE OF RHODE ISLAND

IN GENERAL ASSEMBLY

JANUARY SESSION, A.D. 2019

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A N   A C T

RELATING TO HEALTH AND SAFETY -- THE CONSUMER PROTECTION IN EYE CARE

ACT

     Introduced By: Senators Ciccone, Lombardi, and Gallo

     Date Introduced: February 13, 2019

     Referred To: Senate Health & Human Services

     It is enacted by the General Assembly as follows:

     SECTION 1. Title 23 of the General Laws entitled "HEALTH AND SAFETY" is hereby

amended by adding thereto the following chapter:

CHAPTER 95

THE CONSUMER PROTECTION IN EYE CARE ACT

     23-95-1. Short title.

     This act shall be known and may be cited as the "Consumer Protection in Eye Care Act."

     23-95-2. Definitions.

     As used in this chapter:

     (1) "Automated computer program" means automated equipment or application designed

to be used on a telephone, a computer, or an Internet-accessible device that can be used either in

person or remotely to conduct an eye assessment.

     (2) "Contact lens" means any lens placed directly on the surface of the eye, regardless of

whether or not it is intended to correct a visual defect. Contact lenses are medical devices and

include, but are not limited to, any cosmetic, therapeutic, or corrective lenses.

     (3) "Delegate" means a person tasked by a provider to assist in the examination of the

eyes and adnexa or in the development of a prescription for spectacles and/or contact lenses as

part of a provider's utilization of an automated computer program or other eye examination

equipment.

     (4) "Department" means the Rhode Island department of health.

     (5) "Dispense" means the act of furnishing spectacles or contact lenses to a patient.

     (6) "Established treatment site" means a location where a patient shall seek care where

there is a provider present and sufficient technology and equipment to allow for an adequate

physical evaluation as appropriate for the patient's presenting complaint, and requires a provider

in-person patient relationship.

     (7) "Eye assessment" means an eye care service including, but not limited to, vision test

or screening that produces prescription or prescription renewals for contact lenses, spectacles, or

other ophthalmic goods.

     (8) "Eye examination" means a physical assessment of the ocular health and visual or

refractive status of a patient that does not consist solely of objective refractive data or information

generated by an automated testing device, including an autorefractor, in order to establish a

medical or refractive diagnosis or for the correction of vision disorders.

     (9) "Eye examination equipment" means computerized or manual medical devices used to

measure refractive status and/or ocular health of the patient, including, but not limited to,

Internet-based or local computer programs, automated examination equipment, manual

examination equipment, cameras, scanning lasers, automated refracting devices, non-contact or

contact tonometers.

     (10) "In-person evaluation" means a patient evaluation conducted by a provider who is at

the same physical location as the location of the patient.

     (11) "Prescription" means a provider's handwritten or electronic order for spectacles or

contact lenses based on an eye examination.

     (12) "Provider" means a health care professional licensed under chapter 35.1 or 37 of title

5.

     (13) "Spectacles" means an optical instrument or device worn or used by an individual

that has one or more lenses designed to correct or enhance vision addressing the visual needs of

the individual wearer, commonly known as "glasses" or "eyeglasses", including spectacles that

may be adjusted by the wearer to achieve different types or levels of visual correction or

enhancement. Spectacles does not include an optical instrument or device that is not intended to

correct or enhance vision or is sold without consideration of the visual status of the individual

who will use the optical instrument or device.

     (14) "Supervision" means overseeing the utilization of a delegated automated computer

program or other eye examination equipment and shall be provided by a provider. The utilization

of an automated computer program or other eye examination equipment by a delegate may be

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performed if the examination has been delegated and the delegating provider provides appropriate

on-site supervision and the delegate has met necessary training requirements.

     23-95-3. Dispensing; Prescriptions.

     (a) Except as provided for by § 5-35.1-10, no person may dispense contact lenses or

spectacles in this state to a patient without a valid prescription from a provider.

     (b) A prescription for spectacles or contact lenses:

     (1) Shall contain an expiration date of not less than one year from the date of the eye

examination, unless the provider determines that it is medically appropriate for the prescription to

expire sooner. If the expiration date is less than one year from the date of the eye examination, the

provider shall inform the patient of the reasoning, and document the reasoning in the provider's

medical records for the patient.

     (2) Shall not be made based solely on information about the human eye generated by an

automated computer program.

     (3) Shall take into consideration any medical findings and any refractive error discovered

during the eye examination.

     (4) Shall include the name, non-urgent and emergency contact information, state license

number and physical location of provider issuing the prescription.

     (c) No contact lenses may be sold or dispensed in this state except pursuant to a

prescription which:

     (1) Conforms to state and federal regulations governing such forms and includes the

name, address, and state licensure number of a prescribing practitioner;

     (2) Explicitly states the number of refills; provided, however, that the number of refills

shall be sufficient for, and not excessive of, the provision of the requisite number of contact

lenses under normal use until the expiration date of the prescription;

     (3) Explicitly states that it is for contact lenses and indicates the lens brand name and

type, including all specifications necessary for the ordering or fabrication of lenses; and

     (4) Is kept on file by the person selling or dispensing the contact lenses for at least

twenty-four (24) months after the prescription is filled.

     (d) Anyone who fills a prescription bears the full responsibility of the accuracy of the

contact lenses or spectacles provided under the prescription.

     (e) At no time, without the direction of a prescriber, shall any changes or substitutions be

made in the brand or type of lenses the prescription calls for with the exceptions of tint change if

requested by the patient. However, if a prescription specifies "only" a specific color or tinted lens,

those instructions shall be observed.

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     (f) All sales of and prescriptions for contact lenses in this state shall conform to the

Federal Fairness to Contact Lens Consumers Act, Pub. L. 108-164, 15 U.S.C. § 7601, et seq. The

provisions of this chapter shall be construed in aid of and in conformity with said federal act.

Civil proceedings to enforce the provisions of this chapter may be brought by any board created

under the Rhode Island department of health or by any other interested person through injunction

or other appropriate remedy.

     23-95-4. Emergent technologies.

     No person shall operate or utilize eye assessments generated from an automated computer

program or other eye examination equipment to conduct an eye assessment or to generate a

prescription for contact lenses or spectacles, unless:

     (1) Diagnostic information and data, including photographs and scans, gathered by the

automated computer program are read and interpreted by a provider;

     (2) The provider who reads and interprets the diagnostic information and data, including

photographs and scans, gathered by the automated computer program or delegate, has performed

at least one in-person evaluation of the patient that satisfies the standard of care for an eye

examination as provided for in the general laws and the rules and regulations promulgated by the

department thereunder, at an established treatment site;

     (3) The provider can verify the identity of the patient requesting treatment via the

automated computer program or other eye examination equipment;

     (4) The automated computer program or other eye examination equipment complies with

all the applicable state and federal laws and regulations;

     (5) The name, non-urgent and emergency contact information, state license number and

physical location of providers who read and interpret diagnostic information and data are filed

with the department and disclosed on a publicly accessible website maintained by the owner or

operator of the automated computer program;

     (6) Prior to conducting an eye assessment through an automated computer program, any

entity providing such service shall present to the consumer a disclaimer stating that the automated

computer program is not a substitute for a comprehensive eye health examination, and that the

consumer should consult an optometrist or an ophthalmologist for a complete eye health and

vision examination. The consumer must acknowledge receipt of the disclaimer before proceeding

with the automated computer program; and

     (7) The provider maintains medical malpractice insurance consistent with § 42-14.1-2

and the rules and regulations promulgated thereunder.

     (b) No person shall operate an automated computer program or attempt to provide remote

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vision correction services, or to conduct an eye assessment to generate a spectacle or contact lens

prescription for any individual under the age of eighteen (18) years old.

     (c) A provider utilizing an automated computer program to generate a spectacle or

contact lens prescription shall conform to the standard of care expected of in-person care.

     23-95-5. Delegation.

     (a) Prior to delegating the performance of eye care services, including, but not limited to

refractive eye care services, the delegating provider shall inform the patient of:

     (1) The name, training and qualifications of the individual who will perform the eye care

services;

     (2) The inherent limitations of the service being delegated and any device being used to

perform the service; and

     (3) A description of appropriate care and proper follow-up, including a plan to ensure that

the service meets standards of care.

     (b) A delegate may only perform those services delegated by and under the supervision of

a provider who shall be immediately available to respond promptly to any question or problem

that may arise as a result of the service being provided.

     23-95-6. Violations; Penalty.

     (a) Any person who believes a violation of this chapter or the rules and regulation

adopted pursuant thereto has occurred or been attempted may file a complaint with the

department in writing. If, upon reviewing the complaint, the department determines there is a

reasonable basis to believe a violation or attempted violation has occurred, the department shall

investigate. The department may, on its own initiative or otherwise, initiate an investigation if it

has a reasonable basis to believe a violation of the act or the rules and regulations has occurred or

been attempted. Nothing in this chapter shall be deemed to require the department to wait until

human harm has occurred to initiate an investigation of a violation of this chapter. As part of the

investigation under this section, the department may hold hearings, administer oaths, and take

testimony in person or by deposition. Such hearings shall be conducted pursuant to chapter 35 of

title 42 ("the administrative procedures act"). The findings of the investigation and any hearings

held pursuant to the investigation shall be in writing.

     (b) If, as a result of an investigation pursuant to this section the department finds that a

person has violated or attempted to violate this chapter, it may impose a civil penalty of not more

than one thousand dollars ($1,000) for each violation. If the department finds that a violation or

attempted violation occurred and did not result in significant harm to human health, the

department may issue a warning instead of imposing a civil penalty.

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     (c) Nothing in this section shall restrict the department from enforcing disciplinary action

against a provider pursuant of chapter 35.1 and 37 of title 5, and any rules and regulations

promulgated thereunder.

     23-95-7. Rules and regulations.

     The department, in conjunction with the boards established by §§ 5-35.1-13 and 5-37-1.1,

may adopt and promulgate reasonable rules and regulations to carry out the provisions of this

chapter.

     23-95-8. Severability.

     If any provision of this chapter, any rule or regulation made under this chapter, or the

application of this chapter to any person or circumstance is held invalid by any court of

competent jurisdiction, the remainder of the chapter, rule, or regulation, and the application of the

provision to other persons or circumstances shall not be affected.

     SECTION 2. This act shall take effect upon passage.

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EXPLANATION

BY THE LEGISLATIVE COUNCIL

OF

A N   A C T

RELATING TO HEALTH AND SAFETY -- THE CONSUMER PROTECTION IN EYE CARE

ACT

***

     This act would provide for consumer protection in eye care services by developing

standards and enforcement protocols related to the utilization of emergent technologies in the

provision of eye care services, as well as for the delegation of eye care services by providers.

     This act would take effect upon passage.

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