Court Opinion

ID: 4765997
Source: CourtListenerOpinion
Date Created: 2021-08-16 14:09:40.628548+00
Date Added: 2024-06-11T08:09:14.679891
License: Public Domain

NOT FOR PUBLICATION WITHOUT THE
                            APPROVAL OF THE APPELLATE DIVISION
     This opinion shall not "constitute precedent or be binding upon any court ." Although it is posted on the
  internet, this opinion is binding only on the parties in the case and its use in other cases is limited. R. 1:36-3.

                                                     SUPERIOR COURT OF NEW JERSEY
                                                     APPELLATE DIVISION
                                                     DOCKET NO. A-4268-18

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

                Argued July 27, 2021 – Decided August 16, 2021

                Before Judges Rothstadt and Enright.

                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).

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).

1
   A state regulation defines "injectable pharmacologics" as "any medication
classified as a neurotoxin, adjuvant or therapeutic agent including, but not
limited to, hyaluronic acid (such as Restylane), fillers (such as collagen),
[Botox] or similar products that have been approved by the Federal Food and
Drug Administration." N.J.A.C. 13:30-8.4A(a).
                                                                          A-4268-18
                                       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

                                                                            A-4268-18
                                        3
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. 45:6 -

19." N.J.A.C. 13:30-8.4A(m).

                                                                             A-4268-18
                                        4
      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

                                                                            A-4268-18
                                        5
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.

                                                                            A-4268-18
                                        6
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

2
  According to a publication by Harvard Medical School, temporomandibular
joint dysfunction is "a collection of painful symptoms affecting the jaw joints"
found at the intersection of "the temporal bone of the skull, the jawbone, and
the jaw muscles." Temporomandibular Joint Dysfunction, Harvard Health

                                                                             A-4268-18
                                        7
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 program would

suffice. In December 2008, in response to a request from the New Jersey Society

of Oral and Maxillofacial Surgeons, the Board agreed to exempt oral and

maxillofacial surgeons from the contemplated educational requirements.

      Two years later, on November 1, 2010, the Board published a proposed

regulation in the New Jersey Register and, a year later, adopted the proposed

Publishing (December 15, 2014),
https://www.health.harvard.edu/temporomandibular-joint-dysfunction.
                                                                              A-4268-18
                                         8
regulation without changes as N.J.A.C. 13:30-8.4A. The proposed regulation,

like the adopted regulation, permitted dentists who have completed a "Board-

approved post-doctoral course" in the use of injectable pharmacologics to

administer injectable pharmacologics "for the cosmetic or functional

enhancement of peri-oral tissue," so long as the administration of the injectable

is provided "in a dental treatment setting." 42 N.J.R. 2576-77 (Nov. 1, 2010);

N.J.A.C. 13:30-8.4A(b), (c), (d), (f). And, as already noted, the regulation

clearly provided that it did not authorize dentists to treat patients for conditions

"that are outside the scope of the practice of dentistry, as defined in N.J.S.A.

45:6-19." 42 N.J.R. 2577 (Nov. 1, 2010); N.J.A.C. 13:30-8.4A(m).

      During a period of public commentary following the proposed regulation's

publication in the New Jersey Register, the Board received a number of

comments expressing concern that N.J.A.C. 13:30-8.4A would impermissibly

expand the scope of the practice of dentistry. See 43 N.J.R. 3096-100 (Nov. 21,

2011). The Board addressed these comments by noting that the regulation

specifically provides that it does not authorize dentists to operate outside of the

scope of the practice of dentistry established in N.J.S.A. 45:6-19.            Ibid.

Nevertheless, the record does not reflect that the NJDA or any other party

                                                                              A-4268-18
                                         9
petitioned the Board to modify or repeal the regulation following the Board's

adoption of N.J.A.C. 13:30-8.4A.3

      Despite the clear language of the regulation, on December 7, 2011, the

Board considered an informal inquiry from a dentist who asked, "Can dentists

inject [Botox] in the peri-orbital area, treat crow's feet, and inject in the

forehead?" According to the minutes from its meeting that day, the Board

discussed N.J.A.C. 13:30-8.4A and the Board's intent in promulgating the

regulation and responded to the inquiry in the negative, unless the dentist was

"treating a dental condition as per" N.J.A.C. 13:30-8.4A(m).           The Board

explained that the regulation did not permit dentist licensees to "perform

services outside the permitted scope of practice" and it was not the Board's intent

to permit such services in promulgating the regulation.

      At its regular meeting on April 4, 2012, and again on July 11, 2012, the

Board responded to inquiries from the NJDA's counsel about the status of a

clarification to the regulation regarding the administration of cosmetic Botox

3
   Records kept by the New Jersey Division of Consumer Affairs and
promulgated online reflect that the Board has received no such petition since at
least October 2016. See Rule Proposals and Adoptions, New Jersey Division of
Consumer Affairs, https://www.njconsumeraffairs.gov/Proposals (last visited
July 28, 2021).

                                                                             A-4268-18
                                       10
injections. On both occasions, counsel was informed that the matter was still

under review.    To date, no clarifying publication or modification to the

regulation has been promulgated by the Board.

      In 2019, the NJDA learned that one of its member dentists had been

"offered an opportunity to settle a purported violation of the injectable

pharmacologics regulation." According to NJDA, the member was informed

that "'the use of injectable pharmacologics for areas outside the peri-oral area,

such as cosmetic enhancement for forehead lines or crow's feet, is not within the

scope of practice of dentistry' because it includes 'providing treatment outside

the peri-oral region, as defined in N.J.A.C. 13:30-8.4A(c).'"

      Thereafter, counsel for the NJDA sent a letter to the Board urging that the

Board adopt a "voluntary, temporary moratorium on the enforcement of

N.J.A.C. 13:30-8.4A . . . and defer further action regarding a pending alleged

violation of that regulation against a member of the [NJDA] pending a further

review by the . . . Board." In the letter, the NJDA argued that the Board had

long recognized that "the practice of dentistry includes the maxillofacial area"

and contended that "[i]f that were not the case, then [o]ral and [m]axillofacial

[s]urgeons who possess dentist-only licenses could not practice in those facial

regions regardless of their level of training because they would not be included

                                                                           A-4268-18
                                      11
in the scope of the practice of dentistry."      The NJDA further argued that

determinations on the scope of the practice of dentistry were defined by the

scope of practice intended by the Legislature—not by the amount or type of

"training received by the licensee." Consequentially, the NJDA argued that if

administration of cosmetic injections in the forehead or for crow's feet fell

within the scope of the practice of dentistry for oral and maxillofacial

surgeons—who practice on dentist licenses—then such injections fell within the

scope of the practice of dentistry for other dentist-only licensees as well.

      At its regular meeting on May 1, 2019, the Board addressed the letter from

the NJDA and responded by passing a resolution "affirm[ing the Board's] long-

standing position that recognizes that oral and maxillo-facial surgeons have an

expanded scope of practice based on their extensive additional training." This

appeal followed.

      We conclude from the record here that the Board's action at the May 1,

2019 meeting did not result in an appealable final agency decision under Rule

2:2-3(a)(2). As our Supreme Court has explained:

            Judicial review of administrative agency action is a
            constitutional right. See N.J. Const. art. VI, § 5, ¶ 4.
            Rule 2:2-3(a)(2) also authorizes an appeal as of right to
            the Appellate Division from final decisions or actions
            of any state administrative agency or officer and to
            review the validity of any rule promulgated by a state

                                                                               A-4268-18
                                       12
            administrative agency with the exception of certain tax
            matters.

            [Silviera-Francisco v. Bd. of Educ. of Elizabeth, 224
            N.J. 126, 136 (2016).]

      A final agency decision is characterized by "the absence of or exhaustion

of 'all avenues of internal administrative review'" and may be found where "the

agency communicates with 'unmistakable written notice the finality' of its

decision." Id. at 136-37 (first quoting Bouie v. N.J. Dep't of Cmty. Affs., 407

N.J. Super. 518, 527 (App. Div. 2009); and then quoting In re CAFRA Permit

No. 87-0959-5, 152 N.J. 287, 301 (1997)).

            Final agency action is also characterized by findings of
            fact, conclusions of law, a definitive ruling, and a clear
            statement that the interested party may seek review of
            the decision and the manner in which that may be
            accomplished. Thus, a letter without those necessary
            elements and written in terms that cause[s] the Court to
            consider the letter no more than "a polite refusal" by the
            agency to change its previously stated position could
            not be considered final agency action for purposes of
            triggering a right to appeal.

            [Id. at 139 (citation omitted).]

A final agency action is preferred and typically necessary for appellate review

because a final agency decision "ha[s] a fully developed record," enabling "a

reviewing court [to] engage in meaningful appellate review." ACLU of N.J. v.

Hendricks, 233 N.J. 181, 200-01 (2018).

                                                                         A-4268-18
                                       13
      This court's general policy regarding a party's obligation to exhaust

avenues for administrative review by a state agency is codified in Rule 2:2-

3(a)(2), which provides:

            [A]ppeals may be taken to the Appellate Division as of
            right . . . (2) to review final decisions or actions of any
            state administrative agency or officer, and to review the
            validity of any rule promulgated by such agency or
            officer . . . except that review pursuant to this
            subparagraph shall not be maintainable so long as there
            is available a right of review before any administrative
            agency or officer, unless the interest of justice requires
            otherwise.

Rule 2:2-3(a)(2)'s exhaustion requirement "ensures that claims will be heard, as

a preliminary matter, by a body possessing expertise in the area[,] . . . allows the

parties to create a factual record necessary for meaningful appellate review,"

and provides an agency the opportunity to issue a decision which "may satisfy

the parties and thus obviate [the need to] resort to the courts." Triano v. Div. of

State Lottery, 306 N.J. Super. 114, 121 (App. Div. 1997) (quoting City of Atl.

City v. Laezza, 80 N.J. 255, 265 (1979)). The first consideration is "particularly

important where," as here, "agency interpretation of the relevant statutes or

regulations is desirable." Ibid. (quoting Magliochetti v. State, 276 N.J. Super.

361, 374 (Law Div. 1994)).

                                                                              A-4268-18
                                        14
      This exhaustion requirement is "not an indispensable pre-condition," id.

at 12 (quoting Swede v. City of Clifton, 22 N.J. 303, 315 (1956)), and will

generally be relaxed under the following circumstances: "(1) when only a

question of law exists; (2) when administrative remedies would be futile; (3)

when irreparable harm would result; (4) when jurisdiction of the agency is

doubtful; or (5) when an overriding public interest calls for a prompt judicial

decision," id. at 121-22. "[I]n cases only involving legal questions, jurisdiction

should remain with the agency where the agency is in a special position to

interpret its enabling legislation, can conclusively resolve the issue or issues,

and can provide relief for the plaintiff." Id. at 122 (citing Abbott v. Burke, 100

N.J. 269, 298 (1985)).

      Applying these settled principles here, we conclude that the issues raised

by the NJDA call for resolution through the development of a record and the

Board issuing a final determination after exercising its expertise in the area. We

view the Board's May 1, 2019 response to the NJDA's informal inquiry not as a

final determination but more akin to a "polite refusal" to reconsider its

regulation.   Nor has the NJDA exhausted, or even pursued, any available

administrative remedies. The NJDA's challenge, if pursued, must be formally

presented to the Board for administrative review under the APA to provide a

                                                                            A-4268-18
                                       15
final agency determination and a factual foundation based on relevant evidence

submitted by the NJDA and others. That foundation, once developed, would

provide the Board with an adequate basis for either its rejection of the NJDA's

position or, perhaps, reconsideration of its long-standing limitation, which

would obviate the need for our review.

      The need for the development of a record before the Board is evident from

the NJDA's arguments raised before us, which it summarized as follows:

            There is absolutely nothing in the rulemaking record or
            in any minutes of the Board which would support the
            conclusion that the techniques and/or complexities of
            administering injectable pharmacologic agents below
            the orbit of the eye differ in any respect from their
            administration "for cosmetic or functional enhancement
            of peri-oral tissue" . . . involving disorders or
            conditions like crow's feet or furrows in the forehead.
            Further, while oral and maxillofacial surgeons possess
            years' - more training than general dentists, that training
            pertains to complex facial surgical and cosmetic
            procedures, not to heightened training in administering
            injectable pharmacologics in the region above or below
            the lower orbit of the eye.

      Essentially, the NJDA contends that because dentists and oral and

maxillofacial surgeons operate under the same type of dentist license, and

because there is only one scope of practice for dentistry in N.J.S.A. 45:6-19, if

oral and maxillofacial surgeons are permitted to perform cosmetic procedures in

the maxillofacial area under a dentist license, other licensed dentists should be

                                                                           A-4268-18
                                       16
permitted to do so as well—even if they have not completed the residency

program required to become an oral and maxillofacial surgeon. The validity of

the NJDA's arguments requires a full record to be developed to address their

assertion that there is no distinction between dentists and oral and maxillof acial

surgeons in the context of their respective qualifications to administer injectable

pharmacologics.

      We are satisfied that without a developed factual basis to support the

proposition that there is no rational basis to treat dentists differently from oral

and maxillofacial surgeons, and absent a final agency decision explaining why

such proof, if it exists, should be rejected, we are not able to conduct a

meaningful review of the Board's adoption of the regulation . Nor are we in a

position to review the Board's continuing adherence to the prohibition against

dentists administering injectable pharmacologics in the same manner that oral

and maxillofacial surgeons are permitted to provide that service. The absence

of the type of record and final agency decision contemplated by formal action

under the APA leaves us with no choice but to dismiss this appeal.

      We are not persuaded otherwise by the NJDA's citation to In re Eastwick

Coll. LPN-to-RN Bridge Program, 225 N.J. 533, 536 (2016), a case involving

an appeal from a final agency decision denying accreditation to a nursing

                                                                             A-4268-18
                                       17
program, or to U.S. Bank, N.A., 210 N.J. 187, which addressed an appeal from

a foreclosure judgment.     Both of those cases arose from appeals of final

decisions either by an agency or a court, and not as here from a response to an

informal request.

      Finally, we need not address the NJDA's argument that the Board

interpreting their regulations to prohibit general dentists from administering

cosmetic injections outside of the peri-oral area was impermissible de facto

rulemaking for which the Board failed to provide notice, because that argument

was raised for the first time in the NJDA's reply brief to us. See Gormley v.

Wood-El, 218 N.J. 72, 95 n.8 (2014); Drinker Biddle & Reath LLP v. N.J. Dep't.

of Law & Pub. Safety, 421 N.J. Super. 489, 496 n.5 (App. Div. 2011) (claims

not addressed in merits brief deemed abandoned and could not properly be raised

in a reply brief); see also Pressler and Verniero, Current N.J. Court Rules, cmt.

5 on R. 2:6-2 (2021) ("It is, of course, clear that an issue not briefed is deemed

waived."). We note only that to the extent the NJDA takes issue with the Board's

interpretation of its regulation, they may seek a declaratory ruling from the

Board as to whether that interpretation will be enforced against dentists.

N.J.S.A. 52:14B-8. And, even were we to consider this argument, our review

                                                                            A-4268-18
                                       18
would be hampered by the lack of a developed record demonstrating the Board's

expertise in interpreting their regulations and the relevant statutory authority.

      Appeal dismissed.

                                                                             A-4268-18
                                       19