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RULE PROPOSALS
VOLUME 42, ISSUE 21
ISSUE DATE: NOVEMBER 1, 2010
LAW AND PUBLIC SAFETY
DIVISION OF CONSUMER AFFAIRS
NEW JERSEY BOARD OF DENTISTRY

Proposed Amendment: N.J.A.C. 13:30-8.1

Proposed New Rule: N.J.A.C. 13:30-8.4A

Fee Schedules; Administration of Injectable Pharmacologics

Authorized By: New Jersey State Board of Dentistry, Jonathan Eisenmenger, Executive Director.

Authority: N.J.S.A. 45:1-15.1 and 45:6-3.

Calendar Reference: See Summary below for explanation of exception to calendar requirement.

Proposal Number: PRN 2010-264.
Submit comments by December 31, 2010 to:

Jonathan Eisenmenger, Executive Director
New Jersey State Board of Dentistry
124 Halsey Street
PO Box 45005
Newark , New Jersey 07101

The agency proposal follows:

Summary

The New Jersey State Board of Dentistry (the Board) is proposing a new rule that will permit licensed dentists who satisfy certain education and training requirements to administer injectable pharmacologics. The Board is aware that some dentists are currently administering injectable pharmacologics such as collagen, Botox<(R)> or Restylane<(R)> in their dental practices. The proposed new rule establishes standards and procedures that must be followed in order to ensure that injectable pharmacologics are properly administered, dispensed and prescribed. In addition, the proposed new rule will help to ensure that only those licensed dentists who are appropriately trained will be permitted to administer, dispense or prescribe such medications. Given the ever evolving nature of pharmacological agents and the risks their use can pose to patients, the Board believes that the minimum education and training requirements set forth in the new rule are necessary to ensure the health, safety and welfare of patients.

Proposed new rule N.J.A.C. 13:30-8.4A(a) defines "injectable pharmacologic" to mean any medication classified as a neurotoxin, adjuvant or therapeutic agent, including hyaluronic acid (such as Restylane<(R)>), fillers (such as collagen), Botulinum Toxin Type A (such as Botox<(R)>) or similar products that have been approved by the Federal Food and Drug Administration. Subsection (b) provides that no dentist shall administer an injectable pharmacologic unless he or she meets the minimum standards of training and procedure set forth in the new rule. Pursuant to subsection (c), a dentist may administer an injectable pharmacologic only for the cosmetic or functional enhancement of peri-oral tissue, and such injections may be administered only in a dental treatment setting. The proposed new rule defines "peri-oral area" as the gums, cheeks, jaws, lips and oral cavity and associated tissues in subsection (a), consistent with N.J.S.A. 45:6-19 of the Dental Practice Act.

Education and training requirements are set forth in subsections (d), (e) and (f) of proposed new N.J.A.C. 13:30-8.4A. A dentist who wishes to administer injectable pharmacologics must complete a Board-approved post-doctoral course in injectable pharmacologics at an accredited dental school, in a hospital-based program or in a college or university clinical setting. The Board-approved course must be at least 21 hours in length and must include instruction in anatomy of head and neck, neurophysiology, patient selection, pharmacological effects and contraindications, management of complications and informed consent. Subsection (e) provides that a dentist who holds a specialty permit issued by the Board in oral and maxillofacial surgery shall not be required to complete this 21-hour course prior to administering injectable pharmacologics. The Board believes that exempting specialty permit holders in oral and maxillofacial surgery from the course work requirements of the proposed new rule is warranted because the training such licensees receive to qualify for the oral and maxillofacial surgery specialty permit pursuant to N.J.A.C. 13:30-6.1 is comprehensive and will adequately prepare them to safely and effectively administer injectable pharmacologics.

A course administrator seeking Board approval of a course in injectable pharmacologics must submit a course outline, including course content and objectives, and the curriculum vitae of the instructors pursuant to new N.J.A.C. 13:30-8.4A(f). The course administrator must issue a certificate of completion to a dentist who successfully completes the approved course pursuant to subsection (g). A dentist must submit a certified true copy of the certificate of course completion to the Board within 30 days of completing the course pursuant to subsection (h).

New N.J.A.C. 13:30-8.4A(i) sets forth practice standards for the administration of injectable pharmacologics. Prior to administering, dispensing or prescribing injectable pharmacologics to a patient, a dentist must conduct an appropriate physical examination, obtain a complete medical history, including the patient's previous medications, allergies and sensitivities and assess the dental needs of the patient. The dentist must retain the patient history in the patient's record for at least seven years. Specific notations on the use of injectable pharmacologics, including the type of agent, dosage, duration and any untoward reactions, must be recorded in the patient record.

New N.J.A.C. 13:30-8.4A(j) prohibits a dentist from delegating the administration of an injectable pharmacologic, unless the dentist delegates the administration to a licensed health care professional who is permitted, pursuant to law or rule, to provide injections under the direction of a dentist. Subsection (k) provides that a dentist who uses injectable pharmacologics without first having met the minimum standards for training and the procedures contained in the new rule will be deemed to have deviated from the acceptable standards of practice required of a licensee. Such conduct may subject a dentist to the penalties set forth in N.J.S.A. 45:1-21 et seq.

New N.J.A.C. 13:30-8.4A(l) prohibits a dentist from advertising, offering or otherwise representing the provision of treatment or services related to injectable pharmacologics unless the dentist has completed the course work outlined in the proposed new rule. Subsection (m) provides that nothing in the proposed new rule shall be construed to authorize a dentist to treat diseases, disorders or conditions that are outside the scope of the practice of dentistry, as defined in the Dental Practice Act at N.J.S.A. 45:6-19.

The Board is also proposing an amendment to its fee schedule set forth at N.J.A.C. 13:30-8.1 in order to lower the reinstatement fee for licensed dental hygienists, registered dental assistants and limited registered dental assistants. Currently, N.J.A.C. 13:30-8.1(d) establishes a $ 200.00 reinstatement fee for dentists, dental hygienists, dental assistants and limited registered dental assistants. The Board is proposing to lower the reinstatement fee for dental hygienists, dental assistants and limited registered dental assistants to $ 100.00. The Board believes that a $ 100.00 reinstatement fee for these licensees and registrants is reasonable and is more consistent with the fees charged by the Board for initial licensure and registration and for biennial license and registration renewal for these licensees and registrants. The Board is not proposing any amendment to the reinstatement fee for dentists. The reinstatement fee for dentists remains $ 200.00.

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.

Social Impact

The Board believes that proposed new N.J.A.C. 13:30-8.4A will have a positive impact upon dentists and the patients they serve. The proposed [page=2576] new rule will require dentists who wish to provide injectable pharmacologics to do so only after having satisfied the education and training requirements set forth in the new rule. Such requirements will help to ensure that only those dentists who have been properly trained are authorized to administer injectable pharmacologics to patients. In addition, the proposed new rule will clarify for dentists who do not possess this additional training that they are prohibited from advertising or offering such services.

The Board believes that the proposed amendment to N.J.A.C. 13:30-8.1 may have a positive impact upon licensed dental hygienists, registered dental assistants and limited registered dental assistants who seek to reinstate their licenses and/or registrations following a suspension for failure to renew. The proposed amendment, which will lower the reinstatement fee that these individuals will be required to pay, may make it easier for them to return to active practice.

Economic Impact

The Board believes that proposed new N.J.A.C. 13:30-8.4A may have an economic impact on licensed dentists who are currently administering injectable pharmacologics to the extent that they may incur costs associated with satisfying the education and training requirements imposed by the Board under the new rule. These education and training costs are difficult to ascertain with specificity, and will vary based on the costs imposed by entities approved to offer such courses. The Board, however, believes that the costs to licensees, registrants, permit holders and applicants are outweighed by the benefit to the public in protecting the public's health, safety and welfare by ensuring that dental services are provided by qualified professionals consistent with the professional practice standards established in the rules.

Dentists who choose not to obtain the required training may be impacted by the new rule to the extent that they may no longer provide such services. The Board believes that any adverse economic impact that may be borne by these dentists as a result of the proposed new rule will be outweighed by the benefit to patients in ensuring that injectable pharmacologics are administered only by dentists who are appropriately trained to administer such medications.

Proposed new rule N.J.A.C. 13:30-8.4A may also have an economic impact upon providers who wish to offer Board-approved courses on injectable pharmacologics, to the extent that providers may incur costs to create courses that meet the specifications articulated in the rule. Providers may also incur administrative costs associated with submitting documentation for Board review and approval and in providing course participants with certificates of completion as required under the new rule.

The proposed amendment to N.J.A.C. 13:30-8.1 may have a positive economic impact upon licensed dental hygienists, registered dental assistants and limited registered dental assistants. Licensed dental hygienists, registered dental assistants and limited registered dental assistants who are seeking reinstatement from a suspended license or registration will be required to pay a $ 100.00 reinstatement fee, instead of the current $ 200.00 reinstatement fee.

Federal Standards Statement

A Federal standards analysis is not required because the proposed amendment and new rule are governed by N.J.S.A. 45:6-1 et seq., and are not subject to any Federal requirements or standards.

Jobs Impact

The Board does not believe that the proposed amendment and new rule will result in the creation or loss of jobs in the State.

Agriculture Industry Impact

The proposed amendment and new rule will have no impact on the agriculture industry in the State.

Regulatory Flexibility Statement

Currently, the Board licenses approximately 9,700 dentists and 4,800 dental hygienists and registers approximately 8,000 dental assistants. If Board licensees and registrants are considered "small businesses" within the meaning of the Regulatory Flexibility Act, N.J.S.A. 52:14B-16 et seq., then the following analysis applies.

The proposed amendment to N.J.A.C. 13:30-8.1 will not impose any new reporting or recordkeeping requirements upon licensed dental hygienists and registered dental assistants, but will impose compliance requirements to the extent that dental hygienists and dental assistants will be required to remit the new, lower fee for reinstatement from a suspended license. Proposed new N.J.A.C. 13:30-8.4A will impose various reporting, recordkeeping and compliance requirements upon licensed dentists who administer injectable pharmacologics. These requirements are discussed in the Summary above.

No additional professional services will be needed to comply with the proposed amendment and new rule. The costs of compliance with the proposed amendment and new rule are discussed in the Economic Impact statement above. The Board believes that the proposed amendment and new rule should be uniformly applied to all licensed dentists, licensed dental hygienists and registered dental assistants in order to ensure the health, safety and welfare of the general public in the provision of dental services. Therefore, no differing compliance requirements for any licensed dentists, licensed dental hygienists or registered dental assistants are provided based upon the size of the business.

Smart Growth Impact

The Board does not believe that the proposed amendment and new rule will have any impact upon the achievement of smart growth or upon the implementation of the State Development and Redevelopment Plan.

Housing Affordability Impact

The proposed amendment and new rule will have an insignificant impact on affordable housing in New Jersey and there is an extreme unlikelihood that the rules would evoke a change in the average costs associated with housing because the proposed amendment and new rule concern the use of injectable pharmacologics in the practice of dentistry.

Smart Growth Development Impact

The proposed amendment and new rule will have an insignificant impact on smart growth and there is an extreme unlikelihood that the rules 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 amendment and new rule concern the use of injectable pharmacologics in the practice of dentistry.

Full text of the proposal follows (additions indicated in boldface thus ; deletions indicated in brackets [thus]):

SUBCHAPTER 8. GENERAL PROVISIONS

13:30-8.1 Fee schedules

(a)-(c) (No change.)

 

(d) Reinstatement fee : [for dentists, dental hygienists,

 

registered dental assistants and limited registered dental

 

assistants. . . . . . . . . . . . . . . . . . . . . . . . .

$200.00]

 

 

 

1. Dentists. . . . . . . . . . . . . . . . . . . . . .

$200.00

 

2. Dental hygienists, registered dental assistants and limited

 

registered dental assistants. . . . . . . . . . . . . .

$100.00

(e)-(f) (No change.)

 

 

 

13:30-8.4A Administration of injectable pharmacologics

(a) For purposes of this section, the following words and terms shall have the following meanings, unless the context clearly indicates otherwise.

"Injectable pharmacologic" means any medication classified as a neurotoxin, adjuvant or therapeutic agent including, but not limited to, hyaluronic acid (such as Restylane<(R)>), fillers (such as collagen), Botulinum Toxin Type A (such as Botox<(R)>) or similar products that have been approved by the Federal Food and Drug Administration.

"Peri-oral area" means the gums, cheeks, jaws, lips and oral cavity and associated tissues.

(b) No dentist shall administer an injectable pharmacologic unless the minimum standards of training and procedure set forth in this section are satisfied.

(c) A dentist may administer an injectable pharmacologic for the cosmetic or functional enhancement of peri-oral tissue only in a dental treatment setting.

[page=2577] (d) A dentist may administer an injectable pharmacologic only after having completed a Board-approved post-doctoral course that is sufficient to prepare a dentist to satisfactorily administer injectable pharmacologics safely and effectively, as provided in (f) below. The course shall be offered at an accredited dental school, in a hospital-based program or in a college or university clinical setting.

(e) Notwithstanding (d) above, a dentist who holds a specialty permit in oral and maxillofacial surgery issued by the Board pursuant to N.J.A.C. 13:30-6.1 shall not be required to complete the Board-approved course set forth in (f) below prior to administering injectable pharmacologics.

(f) In order to obtain Board approval for a course on injectable pharmacologics, a course provider shall submit a course outline, including course content and objectives and the curriculum vitae of the instructor(s), for Board review and approval. The course outline shall indicate whether the training is visual, hands-on or lecture. An approved course shall be at least 21 hours in length and shall include instruction in the following:

1. Anatomy of head and neck;

2. Neurophysiology, including facial tissues, parasympathetic, sympathetic and peripheral nervous systems relative to peri-oral tissue, and facial architecture;

3. Patient selection, including indications and contraindications;

4. Pharmacological effects and contraindications, including potential drug interactions;

5. Management of complications; and

6. Informed consent.

(g) The course administrator shall issue a certificate of completion to a dentist who successfully completes the approved course.

(h) A dentist who desires to administer injectable pharmacologics shall submit to the Board, within 30 days of completing the course, a certified true copy of the certificate of course completion provided to the dentist by the course administrator.

(i) Prior to administering, dispensing or prescribing injectable pharmacologics to a patient, the dentist shall conduct an appropriate physical examination within the scope of dental practice, obtain a complete medical history, including the patient's previous medications, allergies and sensitivities and comprehensively assess the dental needs of the patient. The patient history shall be maintained in the patient's record for a period of not less than seven years. Specific notations on the use of injectable pharmacologics, including the type of agent, dosage, duration and any untoward reactions, shall be recorded in the patient record.

(j) A dentist shall not delegate the administration of an injectable pharmacologic, except to a licensed health care professional who is authorized pursuant to the laws and/or rules in this State governing the professional's health care practice to provide injections under the direction of a dentist.

(k) The use of injectable pharmacologics without first having met the minimum standards for training and the procedures contained in this section shall constitute a deviation from the acceptable standards of practice required of a licensee and may subject a dentist to the penalties set forth in N.J.S.A. 45:1-21 et seq.

(l) A dentist shall not advertise, offer or otherwise represent the provision of treatment or services related to injectable pharmacologics unless the dentist has completed the Board-approved course outlined in (f) above.

(m) Nothing in this section shall be construed to authorize a dentist to treat diseases, disorders or conditions that are outside the scope of the practice of dentistry, as defined in N.J.S.A. 45:6-19.

   
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