VOLUME 44, ISSUE 15
ISSUE DATE: AUGUST 6, 2012
LAW AND PUBLIC SAFETY
DIVISION OF CONSUMER AFFAIRS
NEW JERSEY STATE BOARD OF OPTOMETRISTS
44 N.J.R. 2034(a)
Proposed Amendment: N.J.A.C. 13:38-2.4
Requirements for Issuing Prescriptions and Dispensing Medications
Authorized By: New Jersey State Board of Optometrists, Lisa Affinito, Executive Director.
Authority: N.J.S.A. 45:12-1 et seq.
Calendar Reference: See Summary below for explanation of exception to calendar requirement.
Proposal Number: PRN 2012-101.
Submit written comments by October 5, 2012 to:
Lisa Affinito, Executive Director
New Jersey State Board of Optometrists
124 Halsey Street
P.O. Box 45012
Newark, NJ 07101
The agency proposal follows:
The State Board of Optometrists (Board) is proposing to amend N.J.A.C. 13:38-2.4. New subparagraph (d)2i is proposed to permit an optometrist to dispense, at a charge to the patient, a pharmaceutical agent that is delivered to the eye through a contact lens. The primary purpose of these contact lenses is not vision correction; rather these medicated contact lenses represent new technology for the treatment of acute and chronic eye conditions, including, but not limited to, corneal abrasions, glaucoma, dry eye, and allergies. The proposed amendment would make the rule consistent with a statutory modification to N.J.S.A. 45:12-9.11(b), effective May 6, 2010, (P.L. 2010, c. 12), which specifically permits this practice. During the comment period on the Board's proposed readoption of its rules, the Board received a comment suggesting that existing N.J.A.C. 13:38-2.4(d)2 be modified to conform to the present statute; this amendment implements the Board's response to that comment.
The Board has provided a 60-day comment period for this notice of proposal. Therefore, this notice is excepted from the rulemaking calendar requirement pursuant to N.J.A.C. 1:30-3.3(a)5.
The Board has determined that the proposed amendment would have a positive social impact because optometrists would be able to offer a new, safe technology to their patients for the treatment of acute and chronic eye conditions, including, but not limited to, corneal abrasions, glaucoma, dry eye, and allergies. Prior to the invention of the medicated contact lens, patients would manage their acute and chronic eye conditions with eye drops, often applying them several times daily. Compliance with medication orders was frequently an issue in children, elderly patients, and those with dementia. The Board believes that permitting optometrists to treat patients with medicated contact lenses will result in better outcomes for patients with acute and chronic eye conditions, because the time-released medication in the contact lenses will be properly applied and will be administered consistently through the time-release period. Additionally, this technology is consumer friendly; it permits patients who were unable to use conventional contact lenses, such as those with allergies, to use these contact lenses.
The proposed amendment should not impose additional costs on optometrists in New Jersey because it does not contain any proposed fee increases. The Board has determined that the proposed amendment will not have a significant economic impact upon patients. The Board anticipates that the cost of medicated contact lenses will not exceed the cost of conventional contact lenses together with the cost of separate medication. The Board believes that the proposed amendment will have a revenue neutral effect on optometrists. The Board has determined that society will benefit from this technology in the long term, because patients using this technology will be better able to manage their conditions and, in the case of glaucoma, prevent blindness, thus alleviating a burden on the healthcare system and on society.
Federal Standards Statement
A Federal standards analysis is not required because the proposed amendment is governed by N.J.S.A. 45:12-1 et seq., and is not subject to any Federal requirements or standards. The Fairness to Contact Lens Consumers Act § 4(f), 15 U.S.C. § 7603(f) and the Contact Lens Rule, 16 CFR Part 315 are not applicable to this proposed amendment because these Federal standards apply to cosmetic contact lenses, not medicated contact lenses.
The Board does not anticipate that the proposed amendment will increase or decrease jobs in the State.
Agriculture Industry Impact
The proposed amendment will have no impact on the agriculture industry in the State.
[page=2035] Regulatory Flexibility Statement
If, for the purposes of the Act, the approximately 1,328 Board licensees are considered "small businesses," then the following analysis applies.
The proposed amendment to N.J.A.C. 13:38-2.4 will not impose any new reporting, recordkeeping, or compliance requirements upon optometrists. Therefore, a regulatory flexibility analysis is not required.
Housing Affordability Impact Analysis
The proposed amendment will have an insignificant impact on affordable housing in New Jersey and there is an extreme unlikelihood that the rule would evoke a change in the average costs associated with housing because the proposed rule concerns permitting optometrists to dispense contact lenses containing medication lasting more than 72 hours from their office stock at a charge to the patient.
Smart Growth Development Impact Analysis
The proposed amendment will have an insignificant impact on smart growth and there is an extreme unlikelihood that the rule would evoke a change in housing production in Planning Areas 1 or 2, or within designated centers, under the State Development and Redevelopment Plan in New Jersey because the proposed rule concerns permitting optometrists to dispense contact lenses containing medication lasting more than 72 hours from their office stock at a charge to the patient.
Full text of the proposal follows (additions indicated in boldface thus; deletions indicated in brackets [thus]):
13:38-2.4 Requirements for issuing prescriptions and dispensing of medications
(a)-(c) (No change.)
(d) In addition to the provisions of (a) and (b) above, optometrists certified to prescribe pharmaceutical agents pursuant to the provisions of N.J.A.C. 13:38-4 and N.J.S.A. 45:12-9.8 through 9.13 shall comply with the following:
1. (No change.)
2. The optometrist shall not dispense a prescription as provided for in N.J.S.A. 45:12-1 et seq., in an amount exceeding a 72-hour supply unless the prescription is dispensed at no charge to the patient.
i. Notwithstanding (d)2 above, an optometrist may dispense a pharmaceutical agent, as provided for in N.J.S.A. 45:12-1 et seq., that is delivered to the eye through a contact lens and may dispense such pharmaceutical agent at a charge to the patient.
3. (No change.)
(e)-(k) (No change.)