WSR 07-12-053

PROPOSED RULES

DEPARTMENT OF HEALTH


[ Filed June 1, 2007, 11:19 a.m. ]

Original Notice.

Preproposal statement of inquiry was filed as WSR 05-01-017.

Title of Rule and Other Identifying Information: Consumer access to vision care, WAC 246-852-005 Definitions, 246-852-010 Duties of practitioners (pursuant to chapter 106, Laws of 1994), 246-852-020 Prescription for corrective lenses, 246-852-030 Transmittal of patient information and records, and 246-852-040 Retention of patient contact lens records.

Hearing Location(s): Washington State Department of Health, Point Plaza East, 310 Israel Road S.E., Conference Room 153, Tumwater, WA 98501, on July 23, 2007, at 10:00 a.m.

Date of Intended Adoption: August 20, 2007.

Submit Written Comments to: Judy Haenke, Program Manager, P.O. Box 47870, Olympia, WA 98504-7870, (360) 236-4947, web site http://www3.doh.wa.gov/policyreview/, fax (360) 586-4359, by July 16, 2007.

Assistance for Persons with Disabilities: Contact Judy Haenke, program manager, by July 16, 2007, TTY (800) 833-6388 or 711.

Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The Federal Trade Commission Contact Lens Rule, 16 C.F.R. 315.1 through 315.11, relating to practitioner requirements for verification of prescriptions to sellers and release of the contact lens prescription took effect on August 2, 2004. The purpose of the proposed amendments is to bring together the federal regulations relating to contact lenses and the existing consumer access to vision care rules. These amendments will allow practitioners to be better informed about state and federal regulations related to contact lens prescribing and filling of current contact lens prescriptions.

Reasons Supporting Proposal: By combining pertinent federal and state regulations relating to contact lens prescribing, licensed vision care practitioners have a clearer and more complete understanding of the information they need for the initial prescription and contact lens fitting and when responding to requests for verification of contact lens prescriptions. This assures that the public is being provided timely and accurate information related to contact lens prescriptions, and refills.

Statutory Authority for Adoption: RCW 18.195.050.

Statute Being Implemented: RCW 18.195.050.

Rule is necessary because of federal law, 16 C.F.R. 315.1 through 315.11.

Name of Proponent: Department of health, governmental.

Name of Agency Personnel Responsible for Drafting, Implementation, and Enforcement: Judy Haenke, P.O. Box 47870, Olympia, WA 98504-7870, (360) 236-4947.

No small business economic impact statement has been prepared under chapter 19.85 RCW. This rule is exempt from a small business economic impact statement under RCW 19.85.025 and 34.05.310 (4)(c) because the rule incorporates federal regulations without material change.

A cost-benefit analysis is not required under RCW 34.05.328. The rule is exempt from the cost-benefit analysis requirements under RCW 34.05.328 (5)(b) because the rule incorporates federal regulations without material change.

June 1, 2007

M. C. Selecky

Secretary

OTS-8037.5


NEW SECTION
WAC 246-852-005   Definitions.   For the purposes of this chapter, the following definitions apply:

(1) "Contact lens" means any contact lens for which state or federal law requires a prescription including noncorrective or plano contact lenses.

(2) "Initial prescription" means a written directive from a prescriber for corrective lenses and consists of the refractive powers.

(3) "Fitting" means the performance of mechanical procedures and measurements necessary to adapt and fit eyeglasses or contact lenses from an initial written prescription containing the information in WAC 246-852-020. In the case of contact lenses, where a patient requests that the fitting be performed by an optician licensed under chapter 18.34 RCW, the initial prescription from a prescriber must be in writing and fitting includes the selection of physical characteristics of the lenses including conversion of the spectacle power to contact lens equivalents, lens design, material and manufacturer of the lenses, and supervision of the trial wearing of the lenses which may require incidental revisions during the fitting period. The revisions may not alter the effect of the written prescription. The fitting and follow-up evaluation must be completed within six months of the eye examination.

(4) "Finalized contact lens prescription" means a contact lens prescription consisting of the contact lens specifications approved by a prescriber at the conclusion of the follow-up evaluation.

(5) "Contact lens prescription" means a postevaluation finalized prescription, issued by a prescriber in accordance with state and federal law, that contains sufficient information for the complete and accurate filling of a prescription for contact lenses that includes the following:

(a) Name of the patient.

(b) Date of original examination.

(c) Issue date of the finalized contact lens prescription and expiration date of that prescription.

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

(e) Dioptric power.

(f) Lens material, brand name and/or manufacturer.

(g) In the case of a private label contact lens, the name of the manufacturer, trade name of the private label brand, and, if applicable, trade name of an equivalent brand name.

(h) Base curve (inside radius of curvature), or appropriate designation.

(i) Diameter.

(j) Color (when applicable).

(k) Thickness (when applicable).

(l) Secondary/peripheral curves (when applicable).

(m) Special features equivalent to variable curves, fenestration or coating.

(n) Suggested wearing schedule and care regimen.

(o) Signature of the evaluating prescriber.

(6) "Contact lens prescription issue date" means the date on which the patient receives a copy of the finalized contact lens prescription at the completion of the fitting and follow-up evaluation.

(7) "Ophthalmic goods" means eyeglasses or a component or components of eyeglasses, and contact lenses.

(8) "Ophthalmic services" means the measuring, fitting, adjusting, and fabricating of ophthalmic goods subsequent to an eye examination.

(9) "Prescriber" means an ophthalmologist or optometrist who performs eye examinations under chapter 18.53, 18.57, or 18.71 RCW.

(10) "Private label contact lenses" means contact lenses that are sold under the label of a seller where the contact lenses are identical to lenses made by the same manufacturer but sold under other labels.

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AMENDATORY SECTION(Amending WSR 94-17-101, filed 8/17/94, effective 9/17/94)

WAC 246-852-010   Duties of practitioners ((pursuant to chapter 106, Laws of 1994)).   (1) Prescribers, including ophthalmologists and optometrists, under chapters 18.53, 18.57, or 18.71 RCW:

(a) When performing an eye examination including the determination of the refractive condition of the eye, shall provide the patient a copy of the initial prescription at the conclusion of the eye examination. A prescriber may refuse to give the patient a copy of the patient's prescription until the patient has paid for the eye examination or fitting and follow-up evaluation, but only if that prescriber would have required immediate payment from that patient had the examination revealed that no ophthalmic goods were required. Verification of insurance coverage for a service shall be deemed a payment.

(b) Shall, if requested by the patient, at the time of the eye examination, also determine the appropriateness of contact lenses wear and include a notation of "OK for Contacts" or similar language on the prescription if the prescriber would have fitted the patient him or herself, if the patient has no contraindications for contact lenses.

(c) Shall inform the patient that failure to complete the initial fitting and obtain a follow-up evaluation by a prescriber within six months of the initial exam will void the "OK for Contacts" portion of the prescription.

(d) Shall provide a verbal explanation to the patient if the prescriber determines the ocular health of the eye presents a contraindication for contact lenses. Documentation of contraindication will also be maintained in the patient's record.

(e) May exclude categories of contact lenses where clinically indicated.

(f) Shall not expire prescriptions in less than two years, unless a shorter time period is warranted by the ocular health of the eye. If a prescription is to expire in less than two years, an explanatory notation must be made by the prescriber in the patient's record and a verbal explanation given to the patient at the time of the eye examination.

(g) Shall comply with WAC 246-852-020.

(2) When conducting a follow-up evaluation for contact lenses fitted and dispensed by another practitioner, the prescriber:

(a) Shall indicate on the written prescription, "follow-up completed" or similar language, and include his or her name and date of the follow-up;

(b) May charge a reasonable fee at the time the follow-up evaluation is performed;

(c) Shall provide the patient a copy of the finalized contact lens prescription, whether or not the patient requested it.

(d) When directed by any person designated to act on behalf of the patient, the prescriber shall provide or verify the contact lens prescription by electronic or other means.

(3) Opticians under chapter 18.34 RCW:

(a) May perform mechanical procedures and measurements necessary to adapt and fit contact lenses from a written prescription consisting of the refractive powers and a notation of "OK for Contacts" or similar language within six months of the initial eye examination date.

(b) Shall notify patients in writing that a prescriber is to evaluate the initial set of contact lenses on the eye within six months of the eye examination or the "OK for Contacts" portion of the prescription is void and replacement contact lenses will not be dispensed. The patient shall be requested to sign the written notification. The signed or unsigned notification will then be dated and placed in the patient's records.

(4) If the patient is fitted by a practitioner other than the initial prescriber, the contact lens specifications shall be provided to the patient and to a prescriber performing the follow-up evaluation.

(5) When the follow-up evaluation is completed by a prescriber, the approved contact lens specifications shall become a valid contact lens prescription ((with the signature of the evaluating prescriber)). The patient shall be provided a copy of the finalized contact lens prescription as specified in subsection (2)(c) of this section, whether or not the patient requested it. The patient shall be able to obtain replacement contact lenses, from this finalized prescription, for the remainder of the prescription period.

(6) All fitters and dispensers shall distribute safety pamphlets to all contact lens patients designed to inform the patient of consumer and health-related decisions.

[Statutory Authority: 1994 c 106 6. 94-17-101, 246-852-010, filed 8/17/94, effective 9/17/94.]


AMENDATORY SECTION(Amending WSR 94-17-101, filed 8/17/94, effective 9/17/94)

WAC 246-852-020   Initial prescription for corrective lenses.   (1) ((A)) An initial prescription from a prescriber for corrective lenses shall at a minimum include:

(a) Patient name.

(b) Prescriber's name, address, professional license number, phone number and/or facsimile number.

(c) Spectacle prescription.

(d) Prescription expiration date.

(e) Date of eye exam.

(f) Signature of prescriber.

(2) If, at the time of the initial eye examination, the patient requests contact lenses ((and has received an eye examination for contact lenses)), the prescriber shall determine the appropriateness of contact lens wear. If the prescriber would have fitted the patient him or herself, and if the patient has no contraindications for contact lenses, the prescriber shall include a notation of "OK for Contacts" or similar language on the prescription. The initial prescription shall also include:

(a) ((The notation "OK for Contacts" or similar language indicating there are no contraindications for contacts.

(b))) Exclusion of categories of contact lenses, if any.

(((c))) (b) Notation that the "OK for Contacts" portion of the prescription becomes void if the patient fails to complete the initial fitting and obtain the follow-up evaluation by a prescriber within the six-month time period.

(3) When the follow-up evaluation is completed, the approved contact lens specifications shall become a valid prescription ((with the signature of the evaluating prescriber)). The patient shall be able to obtain replacement lenses, from this finalized prescription, for the remainder of the prescription period.

[Statutory Authority: 1994 c 106 6. 94-17-101, 246-852-020, filed 8/17/94, effective 9/17/94.]


AMENDATORY SECTION(Amending WSR 94-17-101, filed 8/17/94, effective 9/17/94)

WAC 246-852-030   Transmittal of patient information ((and)), records, and contact lens prescriptions.   (1) The practitioner who performs the contact lens fitting shall provide the contact lens specifications to a prescriber designated by the patient for the purpose of the follow up and final evaluation. The contact lens specification shall be transmitted to the designated practitioner by telephone, facsimile, mail or by electronic means.

(2) The finalized contact lens prescription ((of the contact lens specifications)) shall be ((available)) provided to the patient ((or)) and, if requested, to the patient's designated practitioner for replacement lenses and ((may)) shall be transmitted by telephone, facsimile or mail or ((provided directly to the patient in writing. The initial prescriber may request and receive the finalized contact lens specifications, if the initial prescriber does not perform the fitting and follow-up evaluation)) by electronic means.

[Statutory Authority: 1994 c 106 6. 94-17-101, 246-852-030, filed 8/17/94, effective 9/17/94.]


AMENDATORY SECTION(Amending WSR 94-17-101, filed 8/17/94, effective 9/17/94)

WAC 246-852-040   Retention of patient contact lens records.   (1) Practitioners shall maintain patient records for a minimum of five years. The records shall include the following which adequately reflects the level of care provided by the practitioners:

(a) The initial written prescription.

(b) Dioptric power.

(c) Lens material, brand name and/or manufacturer.

(d) Base curve (inside radius of curvature), or appropriate designation.

(e) Diameter.

(f) Color (when applicable).

(g) Thickness (when applicable).

(h) Secondary/peripheral curves (when applicable).

(i) Special features equivalent to variable curves, fenestration or coating.

(j) Suggested wearing schedule and care regimen.

(k) In the case of a private label contact lens, the name of the manufacturer, trade name of the private label brand, and, if applicable, trade name of an equivalent brand name.

(2) Opticians' records shall additionally include the following if fitting contact lenses:

(((a))) Documentation of written advisement to the patient of the need to obtain a follow-up evaluation by a prescriber.

(3) Prescribers' records shall additionally include the following:

(a) Documentation of contraindications which would prohibit contact lens wear and documentation that contraindications were explained to the patient by the prescriber.

(b) Explanatory notation of the reasons why a prescription has an expiration date of less than two years, and documentation that the reasons were explained to the patient at the time of the eye examination.

[Statutory Authority: 1994 c 106 6. 94-17-101, 246-852-040, filed 8/17/94, effective 9/17/94.]

Washington State Code Reviser's Office