In re N.J.A.C. 13:30-8.4A Governing Injectable Pharmacologics

• Decision Date: 16 August 2021
• Docket Number: A-4268-18
• Parties: IN THE MATTER OF N.J.A.C. 13:30-8.4A GOVERNING INJECTABLE PHARMACOLOGICS.
• Court: New Jersey Superior Court – Appellate Division

IN THE MATTER OF N.J.A.C. 13:30-8.4A GOVERNING INJECTABLE PHARMACOLOGICS.

No. A-4268-18

Superior Court of New Jersey, Appellate Division

August 16, 2021

NOT FOR PUBLICATION WITHOUT THE APPROVAL OF THE APPELLATE DIVISION

Argued July 27, 2021

On appeal from the New Jersey State Board of Dentistry, Division of Consumer Affairs, Department of Law and Public Safety.

Arthur Meisel argued the cause for appellant New Jersey Dental Association (New Jersey Dental Association, attorneys; Arthur Meisel, on the briefs).

Nancy Costello Miller, Deputy Attorney General, argued the cause for respondent New Jersey State Board of Dentistry (Andrew J Bruck, Acting Attorney General, attorney; Sookie Bae-Park Assistant Attorney General, of counsel; Nancy Costello Miller, on the brief).

Before Judges Rothstadt and Enright.

PER CURIAM.

According to appellant, the New Jersey Dental Association (NJDA), it is appealing from "the construction of a regulation by the New Jersey State Board of Dentistry [(Board)]" that arbitrarily allows oral and maxillofacial surgeons who practice under a dentist-only license, but who have specialized training, to inject pharmacologics such as Botulinum Toxin Type A (Botox) ^[1] into patients' foreheads and orbital-eye areas for cosmetic procedures, while prohibiting general dentists who practice under the same type of license from administering those injections in the same areas. There is no dispute that the appeal is not from a final agency decision by the Board. Rather, the NJDA states the Board's limitation on dentists is arbitrary, capricious and unreasonable because the surgeons and dentists operate under the same kind of dentist-only license, and state regulations do not provide for an expanded scope of practice by oral and maxillofacial surgeons. After considering the parties' contentions on appeal, we conclude that this appeal must be dismissed as it does not meet our requirement for finality or exhaustion of administrative remedies under Rule 2:2-3(a)(2).

We begin our review by observing that under the Dental Practices Act, N.J.S.A. 45:6-1 to -73, the Legislature has vested the Board, like other licensing boards, with the authority to adopt regulations for the administration of the practice of dentistry in New Jersey in order to protect the "public health, safety and welfare." N.J.S.A. 45:1-15.1; see also N.J.S.A. 45:6-1 (establishing the Board); Dentists for Quality Care, Inc. v. N.J. State Bd. of Dentistry, 339 N.J.Super. 257, 266-67 (App. Div. 2001) (discussing the Board's responsibilities). The regulations promulgated by the Board appear in the State's corresponding administrative code, N.J.A.C 13:30-1.1 to -8.26, which apply to "all licensed dentists" and related practitioners. N.J.A.C 13:30-1.1(b).

In relevant part, under the plain language of N.J.S.A. 45:6-19(1), a person engages in dentistry by "[u]s[ing] a dental degree . . . to diagnose, treat, prescribe or operate for any disease, pain, deformity, deficiency, injury, or physical condition of the human tooth, teeth, alveolar process, gums, cheek, or jaws, or oral cavity and associated tissues." It is therefore within the Board's authority to regulate a dentist's use of injectable pharmacologics within those portions of the human anatomy.

Additionally, N.J.S.A. 45:6-19 includes within the definition of the scope of the practice of dentistry, among other things, "any clinical operation included in the curricula of recognized dental schools or colleges." N.J.S.A. 45:6-19 (9). Procedures such as the administration of injectable pharmacologics for the surgical and cosmetic treatment of areas outside of the maxillofacial area, including the forehead and peri-orbital area, are included within the curricula of residency programs approved by the Commission on Dental Accreditation (CODA) for the training of oral and maxillofacial surgeons, but not for dentists. Accordingly, oral and maxillofacial surgeons do not operate outside of their statutorily defined scope of practice when administering such injections in the maxillofacial area outside of the peri-oral area.

As to the regulation governing the administration of injectable pharmacologics, N.J.A.C. 13:30-8.4A largely mirrors the language found in the authorizing statute. The regulation limits a dentist's administration of such injections for the "cosmetic or functional enhancement of peri-oral tissue" to a dental treatment setting and defines the "peri-oral area" as the "gums, cheeks, jaws, lips and oral cavity and associated tissues." N.J.A.C. 13:30-8.4A(a), (c). The regulation reiterates the limitation by stating, "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. 45:619." N.J.A.C. 13:30-8.4A(m).

As the State agency charged with the responsibility for promulgating and enforcing regulations for the practice of dentistry, the Board's final agency determinations, when issued, are entitled to our deference. While we are not bound by a state agency's interpretation of a statute, U.S. Bank, N.A. v. Hough, 210 N.J. 187, 200 (2012), when the agency is charged with enforcing the statute through the adoption of rules and regulations and its construction comports with the legislative design, the agency's interpretation is entitled to substantial deference, Zimmerman v. Sussex Cnty. Educ. Servs. Comm'n, 237 N.J. 465, 475-76 (2019). Our "deference to administrative agencies stems from the recognition that agencies have the specialized expertise necessary to enact regulations dealing with technical matters and are 'particularly well equipped to read and understand the massive documents and to evaluate the factual and technical issues that . . . rulemaking would invite.'" Dentists for Quality Care, Inc., 339 N.J.Super. at 263 (quoting N.J. State League of Muns. v. Dep't of Cmty. Affs., 158 N.J. 211, 222 (1999)).

Here, the NJDA did not afford the Board an opportunity to formally address its challenge to the Board's regulations. The NJDA did not pursue any action before the Board under the Administrative Procedure Act (APA), N.J.S.A. 52:14B-1 to -15, for a declaratory ruling that dentists are authorized to inject pharmacologics in the same fashion that oral and maxillofacial surgeons administer such injections. See N.J.S.A. 52:14B-8 (permitting a party to request from an agency a declaratory ruling after a "[f]ull opportunity for [a] hearing"). Nor did it seek that the regulation be amended or repealed. See N.J.S.A. 52:14B-4(f) (authorizing a party to submit a request that a challenged rule be amended or repealed). See also Dentists for Quality Care, Inc., 339 N.J.Super. at 263 (addressing an appellant's challenge to the Board's promulgation and adoption of a regulation). Instead of making any formal application to the Board, the NJDA pursued an informal procedure in an attempt to change the enforcement of the Board's regulation. For those reasons, the Board never rendered a final agency decision in response to the NJDA's concerns.

The history of the NJDA's informal efforts and the Board's responses are summarized as follows. Since early 2006, the Board has responded to informal inquiries about dentists being able to inject pharmacologics by stating it was permissible as long as they were used

to diagnose, treat, prescribe or operate for any disease, pain, deformity, deficiency, injury, or physical condition of the human tooth, teeth, alveolar process, gums, cheek or jaws, or oral cavity and associated tissues as defined in N.J.S.A. 45:6-19 and provided [the dentists] have adequate training and are aware of the consequences and possible complications of the use of this pharmacological agent.

In April 2006, the Board received a report from its previously established "Botox committee" that recommended the "impos[ition of] an educational requirement before using Botox or fillers and the issuance of a permit." The following month, the Board referred another inquiry to a committee to make recommendations about the "training of a Board certified oral and maxillofacial surgeon in an approved residency and cosmetic and esthetic fellowship and to reconcile such training with the privileges of oral and maxillofacial surgeons." Thereafter, at its regular meeting on July 12, 2006, the Board determined that such procedures were within the scope of the practice of dentistry but could only be performed by oral and maxillofacial surgeons with the "appropriate comprehensive training. "

Since 2006, the Board has repeatedly fielded questions regarding the use of injectable pharmacologics such as Botox, and consistently determined that a dentist's use of injectable pharmacologics "outside of the peri-oral area may be appropriate" only for treatment of dentistry-related issues such as temporomandibular joint dysfunction.^[2] The Board has also entertained questions regarding its interpretation of its regulations and the limitations placed on dentists as compared to oral and maxillofacial surgeons. For example, in 2007, it responded to an inquiry from the American Association of Oral and Maxillofacial Surgeons regarding "dentists administering cosmetic facial fillers." The Board advised that although at that time the regulations provided no express restriction on the performance of such treatment, the Board was in the process of modifying its regulations to impose "limitations and educational requirements."

In April 2008, in response to counsel for the NJDA's inquiry as to what would constitute "appropriate comprehensive training" with respect to performance of cosmetic surgical procedures, the Board recommended that completion of a CODA accredited oral and maxillofacial surgery...