2017 -- H 5674

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LC001882

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     STATE OF RHODE ISLAND

IN GENERAL ASSEMBLY

JANUARY SESSION, A.D. 2017

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A N   A C T

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

ACT

     

     Introduced By: Representatives Jacquard, Vella-Wilkinson, Hearn, Ackerman, and
Azzinaro

     Date Introduced: March 01, 2017

     Referred To: House Health, Education & Welfare

     It is enacted by the General Assembly as follows:

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

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amended by adding thereto the following chapter:

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CHAPTER 94

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THE CONSUMER PROTECTION IN EYE CARE ACT

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     23-94-1. Short title.

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

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     23-94-2. Definitions.

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     (a) As used in this chapter:

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

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

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person or remotely to conduct an eye assessment.

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

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

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

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

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

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

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equipment.

 

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

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

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

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

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

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in-person patient relationship.

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

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

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

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

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

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

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

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

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tonometers.

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

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the same physical location as the location of the patient.

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     (10) "Prescription" means a provider's handwritten or electronic order for glasses or

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contact lenses based on an eye examination.

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     (11) "Provider" is a health care professional licensed under chapters 35.1 or 37 of title 5.

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

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

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

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

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

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enhance vision or sold without consideration of the visual status of the individual who will use

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the optical instrument or device.

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

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

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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

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

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     23-94-3. Purpose.

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     (a) The purpose of this chapter is to provide for the development, establishment, and

 

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enforcement of standards:

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     (1) To ensure and protect quality eye care for individuals receiving eye care in the state;

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and

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     (2) For the encouragement of quality maintenance and improvement in all aspects of eye

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care delivered to individuals in the state.

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     23-94-4. Dispensing; prescriptions.

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

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

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     (b) A valid prescription for spectacles or contact lenses:

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

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examination by the provider or a statement by the provider of the reasons why a shorter time is

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appropriate based on the medical needs of the patient.

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

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automated computer program.

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

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during the eye examination.

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     (4) Shall consider all contact lenses used in the determination of a contact lens

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prescription to be diagnostic lenses.

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     (c) After the diagnostic period and the contact lenses have been adequately fitted and the

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patient is released from immediate follow-up care by persons licensed and regulated by the

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department, the prescribing provider shall, at no cost, provide a prescription in writing for

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replacement contact lenses. A person shall not dispense or adapt contact lenses or spectacles

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without first receiving authorization to do so by a written prescription, except when authorized

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orally by a provider. Patients who comply with such fitting and follow-up requirements as may be

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established by the prescribing provider may obtain replacement contact lenses until the expiration

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date listed on the prescription from a person who may lawfully dispense contact lenses under this

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chapter.

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     (d) No replacement contact lenses may be sold or dispensed in this state except pursuant

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to a prescription which:

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

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

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     (2) Explicitly states an expiration date of not more than twelve (12) months from the date

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of the last prescribing contact lens examination;

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     (3) Explicitly states the number of refills;

 

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

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

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

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

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

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contact lenses or spectacles provided under the prescription.

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

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

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

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those instructions shall be observed.

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

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federal Fairness to Contact Lens Consumers Act, Pub. L. 108-164, 15 U.S.C.A. Section 7601 et

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

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

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

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other appropriate remedy.

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     23-94-5. Emergent technologies.

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     (a) No person shall operate an automated computer program or other eye examination

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equipment to conduct an eye assessment or to generate a prescription for contact lenses or

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spectacles, unless:

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

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automated computer program are read and interpreted by a provider;

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

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

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established doctor-patient relationship with the patient, and has performed at least one in-person

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evaluation of the patient that includes the state mandated required elements for an eye

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examination as provided for in §5-35.1-16 and the rules and regulations promulgated by the

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department thereunder, at an established treatment site;

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

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automated computer program or other eye examination equipment;

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     (4) The automated computer program or other eye examination equipment is approved by

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the federal Food and Drug Administration for the intended use;

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     (5) The automated computer program or other eye examination equipment is designed

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and operated in a manner that provides any applicable accommodation required by the federal

 

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Americans with Disabilities Act of 1990, codified at 42 U.S.C. 12101 et seq., as amended;

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     (6) The automated computer program or other eye examination equipment is used for the

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collection and transmission of information and data, including photographs and scans, gathers and

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transmits protected health information in compliance with the federal Health Insurance Portability

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and Accountability Act of 1996, Pub. L. 104-191, codified at 42 U.S.C. 300(gg), 29 U.S.C. 1181

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et seq., and 42 USC 1320(d) et seq.;

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     (7) The procedure for which the automated computer program or other eye examination

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equipment is used has a recognized current procedural terminology code maintained by the

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American Medical Association;

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     (8) The automated computer program or other eye examination equipment prominently

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displays the name, state license number and physical location of the provider who will read and

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interpret the diagnostic information and data, including photographs and scans as well as non-

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urgent and emergency contact information of said provider;

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     (9) The owner or lessee of the automated computer program or other eye examination

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equipment maintains liability insurance in an amount adequate to cover claims made by

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individuals diagnosed or treated based on information and data, including photographs and scans,

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generated by the service and/or automated computer program; and

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     (10) There is simultaneous interaction between the provider via direct two-way

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communication with the delegate at all times, whereby the provider shall be immediately

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available to respond promptly to any question or problem that may arise as a result of the service

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being provided and shall be immediately available to respond promptly to any question or

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

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     23-94-6. Delegation; written protocol; supervision; training.

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

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refractive eye care services, the provider shall perform an in-person initial evaluation of the

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patient. The delegating provider is responsible for ensuring the delegate performing the service

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has demonstrated sufficient proficiency for the services to be provided. Prior to performing the

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services, the delegating provider shall inform the patient about the training and qualifications of

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who will perform the services.

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     (b) A provider may delegate the performance of eye care services though use of a written

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protocol. The written protocol shall be reviewed annually by the provider and the delegate and

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updated as necessary, be provided to the department or to any patient upon request, and provide:

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     (1) Identification of the device being used to perform the service and its inherent

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limitations;

 

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     (2) Description of appropriate care and proper follow up, including a plan to ensure that

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the service meets nationally recognized standards of care;

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     (3) A quality assurance plan for ongoing management of the patient; and

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     (4) A method for maintaining medical records for the service provided.

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

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a provider. Supervision requires that the provider have direct two-way communication with the

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delegate at all times, and the provider shall be immediately available to respond promptly to any

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

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     (d) A provider who delegates performance of eye care services shall provide, upon

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request by the department, documentation of a delegate's completion of appropriate training in the

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safe and effective use of all components and capabilities of an automated computer program; and

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for each service being provided, it is the responsibility of the delegating provider to ensure that

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the delegate is appropriately trained in the indications, appropriate use, accurate data collection,

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and contraindications involved in the service being provided.

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     23-94-7. Informed consent.

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     (a) It is the responsibility of the provider prior to performing remotely administered eye

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care services, including, but not limited to, vision correction services, to clearly inform the patient

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as to the indications and limitations of the technology to be used as well as alternative evaluation

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and treatment options. This information shall be provided, in writing, to the patient and an

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acknowledgement of receipt, signed by the patient, shall be maintained by the provider for a

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period of two (2) years, and a copy shall be provided to the patient prior to the services being

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rendered.

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     23-94-8. Age minimum.

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     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

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

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     23-94-9. Standard of care.

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     Evaluation, treatment, and consultation recommendations made by a provider utilizing an

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automated computer program, including issuing a prescription via electronic means, shall be held

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to the same standards of appropriate practice as those in traditional in-person clinical settings.

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     23-94-10. Violations; penalty; private right of action.

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

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

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

 

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

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

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

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

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

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

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testimony in person or by deposition. Such hearings shall be conducted pursuant to the

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administrative procedure act, chapter 35 of title 42. The findings of the investigation and any

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hearings held pursuant to the investigation shall be in writing.

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

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

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than ten thousand dollars ($10,000) for each violation. If the department finds that a violation or

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

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

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pursuant to this section may be collected as provided in such section. At the request of the

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department, the attorney general may file a civil action seeking an injunction or other appropriate

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relief to enforce this chapter and the rules and regulations adopted and promulgated thereunder.

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     (c) In addition to any remedies under this chapter, the rules and regulation adopted

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thereunder, or other provisions of state or federal law, a person adversely affected by a violation

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of this chapter may bring action for injunctive relief and, upon prevailing, in addition to such

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injunctive relief, shall recover monetary damages of no more than one thousand dollars ($1,000)

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for each day found to be in violation plus attorneys' fees and costs.

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     23-94-11. Rules and regulations.

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

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

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chapter.

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     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

***

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

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

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

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     This act would take effect upon passage.

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