2020 -- S 2610

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LC004722

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     STATE OF RHODE ISLAND

IN GENERAL ASSEMBLY

JANUARY SESSION, A.D. 2020

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A N   A C T

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

     Introduced By: Senators Ciccone, Lombardo, Lombardi, Lawson, and Goodwin

     Date Introduced: February 25, 2020

     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 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.

     (a) As used in this chapter:

     (1) “Assessment mechanism” means automated or virtual equipment, application, or

technology designed to be used on a telephone, a computer, or an Internet-accessible device that

may be used either in person or remotely to conduct an eye assessment, and includes artificial

intelligence devices and any equipment, electronic or nonelectronic, that is used to perform 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, including any cosmetic, therapeutic, or

corrective lens.

     (3) “Eye assessment” means an assessment of the ocular health and visual status of a patient

that may include, but is not limited to, objective refractive data or information generated by an

automated testing device, including an autorefractor, in order to establish a medical diagnosis for

the correction of vision disorders.

     (4) “Person” means an individual, corporation, trust, partnership, incorporated or

unincorporated association, and any other legal entity.

     (5) “Prescription” means a handwritten or electronic order issued by a provider, or an oral

order issued directly by a provider.

     (6) “Provider” is a health care professional licensed under chapter 35.1 or 37 of title 5.

     (7) “Seller” means an individual or entity that sells contact lenses or visual aid glasses and

dispenses them in Rhode Island in any manner.

     (8) “Visual aid glasses” means eyeglasses, spectacles, or lenses designed or used to correct

visual defects, including spectacles that may be adjusted by the wearer to achieve different types

or levels of visual correction or enhancement. Visual aid glasses do not include optical instrument

or devices that are:

     (i) Not intended to correct or enhance vision;

     (ii) Sold without consideration of the visual status of the individual who will use the optical

instrument or device, including nonprescription sunglasses, plano lenses that are clear, colored or

tinted, or lenses that are designed and used solely to filter out light; or

     (iii) Completely assembled eyeglasses or spectacles designed and used solely to magnify.

     23-95-3. Prescriptions - Content; release.

     (a) A contact lens prescription shall include the following:

     (1) The ophthalmic information necessary to accurately fabricate or dispense the lenses,

including the lens manufacturer, lens series, and the lens material if applicable;

     (2) Power and base curve;

     (3) Name, license number, telephone number, and for written orders, the signature of the

prescribing provider;

     (4) Patient’s name and address, expiration date of the prescription, and number of refills or

lenses permitted; and

     (5) The date of issuance.

     (b) A contact lens prescription may also include the diameter, axis, add power, cylinder,

peripheral curve, optical zone and center thickness.

     (c) A prescription for visual aid glasses shall include the following:

     (1) The name, license number, telephone number, and for written orders, the signature of

the prescribing provider;

     (2) The patient’s name;

     (3) The date of issuance; and

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     (4) The value of all parameters the provider has deemed necessary to dispense corrective

lenses appropriate for a patient.

     (d) A provider shall not refuse to release a prescription for contact lenses or visual aid

glasses to a patient.

     23-95-4. Verification of contact lens prescriptions.

     (a) All contact lens sellers and any person authorized under the general laws to dispense

contact lenses in the state shall verify the contact lens prescription by the following:

     (1) Receipt of a written or faxed valid contact lens prescription signed by the prescribing

provider; or

     (2) An electronic or oral affirmative communication of the complete contact lens

prescription from the prescribing provider.

     (b) If a contact lens seller or any person authorized to dispense contact lenses in the state

finds it necessary to contact the prescribing provider via telephone in order to verify a contact lens

prescription, the following protocols shall be followed:

     (1) Calls shall be made during regular business hours;

     (2) Any verification requests shall include the name, address, and telephone number of the

patient;

     (3) The toll-free telephone number as required by § 23-95-7(a)(7) shall be included in voice

mail or messages left on answering machines;

     (4) Contact lens prescriptions shall not be mailed, sent, delivered, or dispensed before

verification by the provider;

     (5) Touch-tone telephone options offered by a contact lens seller or any person authorized

to dispense contact lenses in the state shall not constitute verification; and

     (6) Response-time options stated by a contact lens seller or any person authorized to

dispense contact lenses in the state shall not constitute verification.

     (c) In the absence of a prescription as defined and described in this chapter, it shall be a

violation of this chapter to dispense contact lenses in Rhode Island in any manner.

     23-95-5. Dispensing.

     (a) Any contact lens seller or any person authorized to dispense contact lenses or visual aid

glasses in the state who fills a prescription bears the full responsibility for the accurate dispensing

of the contact lenses or visual aid glasses provided under the prescription. At no time shall any

changes or substitutions be made including brand, type of lenses, or ophthalmic parameters without

the direction of the provider who issued the contact lens or visual aid glasses prescription.

     (b) The provider shall not be liable for any damages for injury resulting from the packaging,

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manufacturing, or dispensing of the contact lenses or visual aid glasses.

     23-95-6. Prerequisites for writing contact lens prescriptions.

     (a) A contact lens fitting shall be complete and a contact lens prescription may be written

when:

     (1) The provider has completed all measurements, tests, and examinations necessary to

satisfy his or her professional judgment that the patient is a viable candidate to wear contact lenses,

recognizing that more than one visit between the patient and the provider may be required; and

     (2) Contact lenses suitable for the patient’s eyes have been evaluated and fitted by the

provider to the patient’s eyes and the provider is satisfied with the fitting based on ocular health

and the visual needs of the patient.

     (b) The patient shall be entitled to receive a copy of the contact lens prescription until its

expiration date.

     23-95-7. Registration of nonresident contact lens sellers.

     (a) The department of health shall require and provide for the annual registration of all

contact lens sellers located outside of the state that dispense contact lenses in Rhode Island

including those providing contact lenses via the Internet. A contact lens seller's registration shall

be granted upon the disclosure and certification by the seller of all of the following:

     (1) The seller is licensed or registered to distribute contact lenses in the state in which the

dispensing facility is located and from which the contact lenses are dispensed;

     (2) The location, names, and titles of all owners, partners, corporate officers, and the person

who is responsible for overseeing the dispensing of contact lenses to persons in this state;

     (3) The seller has complied with and shall continue to comply with all lawful directives

and appropriate requests for information from the appropriate agency of each state in which the

seller is licensed or registered;

     (4) The seller shall respond to all requests for information from the department of health

within thirty (30) days from receipt of the request;

     (5) The seller shall maintain records of contact lenses dispensed to persons in this state for

a period of ten (10) years, and that the records shall be readily available for inspection by the

department of health upon demand;

     (6) The seller shall provide a toll-free telephone service during its regular hours of

operation for the sole purpose of responding to the patients in this state concerning questions and

complaints. All questions relating to eye care shall be referred to the doctor prescribing the contact

lenses;

     (7) The seller shall provide a toll-free telephone service during its regular hours of

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operation solely for providers.

     (8) The seller shall provide the following or a substantially equivalent written notification

to the patient whenever contact lenses are supplied: WARNING: IF YOU ARE HAVING ANY

OF THE FOLLOWING SYMPTOMS REMOVE YOUR CONTACT LENSES IMMEDIATELY

AND CONSULT YOUR EYE CARE PRACTITIONER BEFORE WEARING YOUR LENSES

AGAIN: UNEXPLAINED EYE DISCOMFORT, WATERING, VISION CHANGE, OR

REDNESS; and

     (9) The seller's license or registration, in the state in which the seller is licensed or

registered, has not been suspended or revoked, but should the seller be the subject of any

investigation undertaken by the licensing or registering state, or should the seller's license or

registration be suspended or revoked, then the seller shall immediately notify the department of

health of such actions.

     23-95-8. Assessment Mechanisms.

     (a) An assessment mechanism to conduct an eye assessment or to generate a prescription

for contact lenses or visual aid glasses in Rhode Island shall:

     (1) Provide synchronous or asynchronous interaction between the patient and the provider;

     (2) Collect the patient’s medical history, previous prescription for corrective eyewear, and

length of time since the patient’s most recent in-person comprehensive eye health examination;

     (3) Provide any applicable accommodation required by the federal Americans with

Disabilities Act, 42 U.S.C. sec. 12101 et seq., as amended;

     (4) Gather and transmit protected health information in compliance with the federal Health

Insurance Portability and Accountability Act of 1996 as amended;

     (5) Be used to perform a procedure with a recognized Current Procedural Terminology

code maintained by the American Medical Association, if applicable; and

     (6) Maintain liability insurance, through its owner or lessee, in an amount adequate to cover

claims made by individuals diagnosed or treated based on information and data, including any

photographs and scans, generated by the assessment mechanism.

     (b) A provider shall:

     (1) Read and interpret the diagnostic information and data, including any photographs and

scans, gathered by the assessment mechanism;

     (2) Verify the identity of the patient requesting treatment via the assessment mechanism;

     (3) Create and maintain a medical record for each patient, which is for use during the

ongoing treatment of a patient, and complies with all state and federal laws regarding maintenance

and accessibility;

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     (4) Provide a handwritten or electronic signature, along with their Rhode Island state

license number, certifying their diagnosis, evaluation, treatment, prescription, or consultation

recommendations of the patient;

     (5) Utilize an assessment mechanism for an eye assessment or to generate a prescription

for visual aid glasses only if:

     (i) The patient is at least eighteen (18) years of age; and

     (ii) The patient has received an in-person comprehensive eye examination by a provider

within the previous twenty-four (24) months.

     (6) Utilize an assessment mechanism to generate a prescription for contact lenses only if:

     (i) The patient is at least eighteen (18) years of age; and

     (ii) The patient has received an in-person comprehensive eye health examination by a

provider:

     (A) For the initial prescription and one follow-up or first renewal of the initial prescription;

or

     (B) Within twenty-four (24) months after the follow-up or first renewal of the initial

prescription, and every twenty-four (24) months thereafter.

     (c) Prior to using an assessment mechanism, each Rhode Island patient shall be provided

with and shall accept as a term of use a disclosure that includes the following information:

     (1) This assessment is not a replacement for an in-person comprehensive eye health

examination;

     (2) This assessment cannot be used to generate an initial prescription for contact lenses or

a follow-up or first renewal of the initial prescription;

     (3) This assessment may only be used if the patient has had an in-person comprehensive

eye health examination within the previous twenty-four (24) months if the patient is conducting an

eye assessment or receiving a prescription for visual aid glasses; and

     (4) The United States Centers for Disease Control and Prevention (CDC) advises contact

lens wearers to visit an eye doctor one time a year or more often if needed.

     (d) Evaluation, treatment, and consultation recommendations by a provider utilizing an

assessment mechanism as requested in this chapter, including issuing a prescription via electronic

means, shall be held to the same standards of appropriate practice as those in traditional in-person

clinical settings.

     (e) This section shall not:

     (1) Limit the discretion of a provider to direct a patient to utilize any tele-health service

deemed appropriate for any treatment and care of the patient;

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     (2) Limit the sharing of patient information, in whatever form, between providers; or

     (3) Apply beyond ocular health and eye care.

     23-95-9. Fees.

     The department of health shall charge a fee for investigation and registration of nonresident

dispensers of contact lenses and visual aid glasses.

     23-95-10. Penalties.

     (a) Any person who dispenses, offers to dispense, or attempts to dispense contact lenses or

visual aid glasses in violation of this chapter or the rules or regulations promulgated by the

department of health concerning the dispensing of contact lenses or visual aid glasses shall, in

addition to any other penalty provided by law, pay a civil penalty to the department of health in an

amount not to exceed ten thousand dollars ($10,000) for each violation.

     (b) Any person charged in a complaint filed by the department of health with violating any

of the provisions of this chapter shall be entitled to an administrative hearing conducted in

accordance with § 42-35-1, et seq.

     (c) Any person aggrieved by a final order issued under the authority of this chapter shall

have the right of an appeal by filing a petition in the state superior court.

     (d) Nothing in this chapter shall restrict the department of health from enforcing

disciplinary action against a provider pursuant to chapters 35.1 and 37 of title 5, and any rules or

regulations promulgated thereunder.

     23-95-11. Rules and Regulations.

     The department of health may adopt and promulgate reasonable rules and regulations to

carry out the provisions of this chapter.

     23-95-12. Severability.

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

application of this chapter to any person or circumstances is held invalid by a court of competent

jurisdiction, the remainder of the chapter, rule, or regulation, and the application of this provision

to other persons or circumstances, shall not be affected.

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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 -- CONSUMER PROTECTION IN EYE CARE ACT

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     This act would create the Consumer Protection in Eye Care Act which establishes standards

for eyeglass prescriptions, verification of contact lens prescriptions, dispensing of contact lenses

and glasses, prerequisites for writing prescriptions, registration of nonresident contact lens sellers,

and assessment mechanisms to conduct an eye assessment test.

     This act would take effect upon passage.

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