[Federal Register Volume 89, Number 170 (Tuesday, September 3, 2024)]
[Notices]
[Pages 71427-71431]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-19730]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 23-40]
Stephen McCarthy, P.A.; Decision and Order
On April 21, 2023, the Drug Enforcement Administration (DEA or
Government) issued an Order to Show Cause (OSC) to Stephen McCarthy,
P.A., (Respondent) of Allentown, Pennsylvania. OSC, at 1, 4. The OSC
proposed the revocation of Respondent's DEA Certificate of
Registration, Control No. MM3329578, alleging that Respondent's
continued registration is inconsistent with the public interest. Id. at
1 (citing 21 U.S.C. 823(g)(1), 824(a)(4)).
A hearing was held before DEA Administrative Law Judge Paul E.
Soeffing (the ALJ), who, on October 27, 2023, issued his Recommended
Rulings, Findings of Fact, Conclusions of Law, and Decision
(Recommended Decision or RD), which recommended revocation of
Respondent's registration. RD, at 30. Following the issuance of the RD,
Respondent filed his Exceptions to the Recommended Decision
(Exceptions).\1\ Having reviewed the entire record, the Agency adopts
and hereby incorporates by reference the entirety of the ALJ's rulings,
credibility findings,\2\ findings of fact, conclusions of law,
sanctions analysis, and recommended sanction as found in the RD.
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\1\ The Agency has reviewed and considered Respondent's
exceptions and addresses them herein, but ultimately agrees with the
ALJ's recommendation.
\2\ The Agency adopts the ALJ's summary of each of the
witnesses' testimonies as well as the ALJ's assessment of each of
the witnesses' credibility. See RD, at 2-13. The Agency agrees with
the ALJ that the testimony from the DEA Diversion Investigator (DI),
which was primarily focused on the introduction of the Government's
documentary evidence and the DI's involvement with the case, was
generally consistent without indication of any animosity towards
Respondent and thus was fully credible and warranted substantial
weight. Id. at 5. The Agency also agrees with the ALJ that the
testimony from Dr. F., which was focused on Dr. F.'s role as a
supervisory physician, her written supervisory agreement with
Respondent, and her experience with the Pennsylvania Licensing
System, was genuine and internally consistent and thus was fully
credible and warranted substantial weight. Id. at 8. Finally, the
Agency agrees with the ALJ that the testimony from Respondent, which
was focused on his experience as a physician assistant operating
under supervising agreements, his understanding regarding his
written agreement with Dr. F., and his descriptions of the
prescriptions he issued during the relevant time period, appeared
genuine but for one major inconsistency regarding his use of auto-
populated settings identifying Dr. M. as the supervising physician
during the relevant time. Id. at 12; see also infra III. Based on
this inconsistency and Respondent's personal interest in the outcome
of the proceedings, the ALJ found, and the Agency agrees, that
Respondent's testimony warranted reduced weight, especially where in
conflict with the testimony of other witnesses and evidence
presented during the hearing. Id. at 12-13.
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I. Findings of Fact
1. Respondent's Written Agreement With Dr. F.
Respondent is a certified physician assistant licensed to practice
in Pennsylvania and has been practicing since October 2014. RD, at 8;
Tr. 56. Respondent was employed at Nulton Diagnostic & Treatment Center
(Nulton) between May 2019 and August 14, 2022. RD, at 8; Tr. 57.
Beginning in October 2020 and lasting through August 2022, Respondent
was also employed at PA Treatment Center. RD, at 8; Tr. 57-58. Dr. F.
is a psychiatrist licensed to practice in Pennsylvania who began
working for Nulton in 2019. RD, at 5; Tr. 40. Dr. F. did not work at PA
Treatment Center. Tr. 37-38.
Dr. F. met Respondent in approximately the spring of 2019 while she
was considering a job at Nulton. RD, at 6; Tr. 40-41. Respondent
testified that this initial meeting was the only time he ever spoke to
Dr. F. RD, at 10, Tr. 9. Dr. F. testified that after the initial
meeting, she entered into a written agreement with Respondent wherein
Dr. F. served as Respondent's supervising physician. RD, at 6; Tr. 41.
However, shortly after Dr. F. began work at Nulton, her supervisory
capacities were allocated elsewhere, so she and Respondent never
actually engaged in a supervisory relationship even during the pendency
of the agreement. RD, at 7; Tr. 46. Dr. F. testified that the written
agreement lasted from August 22, 2019, to October 7, 2019. RD, at 6;
Tr. 41, 46. Respondent testified that while working at Nulton, he had
supervising agreements with various physicians, including Dr. F. RD, at
8; Tr. 58.
Dr. F. testified that generally, a written agreement is made
between a board-certified physician and a physician assistant and that
these agreements have two major components: the first, ``to delegate
the medical services that the [physician assistant] should perform,''
and the second, ``that
[[Page 71428]]
the physician should be supervising the [physician assistant] to carry
out those medical services or those medical duties.'' RD, at 6; Tr.
41.\3\ Dr. F. testified that when she is supervising a physician's
assistant, she ``make[s] it a point to sign off on every note
individually, to at least scan the notes for consistency.'' \4\ RD, at
6; Tr. 41-42. Dr. F. also testified that once a year, she does ``a deep
dive in each individual case to make sure that it's moving correctly.''
RD, at 6; Tr. 42. Dr. F. explained that any time one of her supervisees
wants to make any major medical changes, the supervisee will contact
her and they will either text or have a phone conversation about it.
RD, at 6; Tr. 42. Dr. F. further explained that her ``fingers are
closely laced into every case that's supervised under [her] name'' and
she meets in ``weekly face-to-face telecommunication supervision, where
[she] bring[s] up individual challenging cases'' with her supervisees.
RD, at 6; Tr. 42. Despite her agreement with Respondent, Dr. F. never
actually functioned as a supervisor for Respondent. RD, at 6-7; Tr. 43.
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\3\ Respondent similarly testified that a written agreement
requires that both the physician and physician assistant sign a
document agreeing to the terms of supervision; the physician must
also ``specify in very basic terms what the duties of the physician
assistant will be under the agreement.'' RD, at 9; Tr. 59.
\4\ Dr. F. testified that ``notes'' are legally required records
based on patient encounters with the supervising physician or the
physician assistant and are expected to contain basic information
regarding the patient's visit. RD, at 6 n.18; Tr. 42-43.
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Respondent testified that ``under Pennsylvania law, [his] duties as
a physician assistant are to evaluate, treat, and provide care to
patients under the supervision of a doctor.'' RD, at 8; Tr. 56-57.\5\
Respondent testified that his ``role in [a] written agreement is
defined by the written agreement itself.'' RD, at 9; Tr. 82. According
to Respondent, in his experience, he has an ``independent caseload of
patients'' wherein he has ``made decisions regarding their treatment
without input from the physician, and . . . consulted the physician
only in times of question, in times [] when [he is] uncertain about how
to proceed with treatment or if [he has] questions about managing a
patient.'' RD, at 9; Tr. 83. In this case, however, it is important to
note that Pennsylvania regulations provide that a physician assistant
``shall not independently prescribe or dispense drugs.'' 63 Pa. Cons.
Stat. section 422.13(f); see also 49 Pa. Code section 18.152(a)(2).
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\5\ Respondent asserted, however, that a supervising physician
``is not required by law'' to review Respondent's charts and
treatment because Respondent has been ``practicing for more than a
year.'' RD, at 9 n.24; Tr. 84. Respondent provided no citation to
Pennsylvania law to support this assertion, nor does the Agency find
any support for this assertion in Pennsylvania regulations. Such
lack of support detracts from Respondent's overall credibility as
well as the weight afforded Respondent's statement.
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Respondent asserted that ``the supervising physician's role is to
provide oversight of [his] treatment . . . [but] what that degree of
oversight is[,] is dictated by the written agreement itself.'' RD, at
9; Tr. 83. Respondent testified that ``in almost all the written
agreements [he has] participated in, the physicians were very hands off
and only communicated with [him] if there was a particular issue.'' RD,
at 9; Tr. 83-84.\6\
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\6\ Respondent noted that in one instance, he never even met the
supervising physician, never reviewed a case with the supervising
physician, never did a case review, and never spoke with the
supervising physician. RD, at 9 n.24; Tr. 84. Respondent reiterated
that it was not unusual for him to have little communication with
his supervising physician and that he has supervising physicians
whom he has never met or spoken to. RD, at 9 n.24; Tr. 96-97.
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Respondent testified that even when his written agreement with Dr.
F. was active (according to the Government's documentary evidence), he
``never consulted with her.'' RD, at 10; Tr. 94. Dr. F. also testified
that she did not talk or consult with Respondent regarding patient care
or any other matters in 2022. RD, at 7; Tr. 45. Not only did Respondent
not consult with Dr. F., he testified that he had no conversations with
Dr. F. at all during the course of their agreement. RD, at 10 n.27; Tr.
95. Even so, Respondent claimed that his non-existent relationship with
Dr. F. was ``not that unusual,'' and that he has had ``supervising
physicians [he has] never met or spoken to.'' Tr. 96. Respondent did
not testify regarding whether or not he had written controlled
substance prescriptions under the authority of those supervising
physicians he had never spoken to.
2. Notification of Termination of Respondent's Agreement With Dr. F.
It is undisputed that the agreement between Respondent and Dr. F.
ended in October 2019. RD, at 10; Tr. 85-86. However, Respondent
testified that he was never notified that the agreement was terminated,
so he believed that from August 2022 through November 2022, he was
still covered under the agreement with Dr. F. RD, at 8, 10; Tr. 58, 86.
Respondent testified that he believed the agreement remained in place
even after he left Nulton in August 2022, because he believed that
``[a]ccording to the law, the agreement does not end when your
employment ends.'' Tr. 98.\7\
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\7\ Respondent again provided no citation to Pennsylvania law to
support this assertion, nor does the Agency find any support for
this assertion in the Pennsylvania regulations. See 49 Pa. Code
section 18.172 (``The physician assistant is required to notify the
Board, in writing, of a change in . . . employment . . . [and]
provide the Board with the new . . . address of employment and name
of registered supervising physician.''). Once more, as well as in
other instances in this Decision, such lack of support detracts from
Respondent's overall credibility as well as the weight afforded
Respondent's statement.
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Dr. F. testified that she did not contact Respondent regarding
inactivation of their agreement and did not discuss her receipt of the
termination letter from the Board with Respondent. RD, at 7; Tr. 46-48.
The Agency notes that the October 8, 2019 termination letter
indicates that Respondent was provided a copy of the letter. See GX 14.
However, in support of his belief that the agreement between himself
and Dr. F. remained in effect, Respondent produced a 2023 printout from
the Pennsylvania Licensing System (PALS) website that includes the
``association start date'' for the supervisory agreement between
Respondent and Dr. F., but no ``association end date.'' Respondent
Exhibit 2, at 5. Testimony from both parties support a finding that the
PALS system could contain inaccuracies. RD, at 7, 11, 23; Tr. 51, 98-
99.
3. Respondent's Improper Prescribing
It is undisputed that between August 24, 2022, and September 20,
2022, and between October 6, 2022, and November 8, 2022, Respondent
issued approximately seventeen (17) prescriptions for controlled
substances to patients \8\ without being party to a written agreement
with a supervising physician. RD, at 21; Tr. 71-81; GX 8, 12. However,
Respondent testified that when he prescribed the relevant controlled
substances, he did so while believing that he was operating under a
valid written agreement with Dr. F. RD, at 11; Tr. 81. None of the
patients who received the 17 prescriptions were treated at Nulton; they
were treated at the PA Treatment Center where Dr. F. had never been
employed. RD, at 23; Tr. 72, 75, 77-79, 104. Further, on cross-
examination, Respondent acknowledged that Dr. F.'s name did not appear
on the relevant prescriptions and that the ``supervising prescriber''
section of the
[[Page 71429]]
prescriptions was blank.\9\ RD, at 11-12, 25; Tr. 88-91; GX 8.\10\
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\8\ Respondent testified about the multiple patients whom he
treated during his time at the PA Treatment Center as well as the
risks of harm associated with abrupt cessation of medication,
particularly for patients diagnosed with opioid disorders. RD, at
11; Tr. 71-81.
\9\ According to Respondent, a pharmacy would typically fill out
the information on the prescription identifying the supervising
prescriber, and it was thus his practice to leave the supervising
prescriber section blank. RD, at 12; Tr. 91, 93-94.
\10\ The ALJ noted that the note portion of some of the
prescriptions indicates that the supervising physician was Dr. M.,
whose agreement with Respondent terminated in December 2021. RD, at
25; Tr. 88-90, 92; RX 1, at 5.
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Federal law requires that ``[a] prescription for a controlled
substance to be effective must be issued for a legitimate medical
purpose by an individual practitioner acting in the usual course of his
professional practice.'' 21 CFR 1306.04(a). Moreover, Pennsylvania
regulations provide that a physician assistant may only perform medical
services as approved within a written agreement with a supervising
physician; ``shall not independently prescribe or dispense drugs''; and
may not ``[p]rescribe or dispense drugs except as described in the
written agreement.'' 49 Pa. Code section 18.152(a)(2); 63 Pa. Cons.
Stat. section 422.13(a), (e), (f).
Here, the Agency finds that Respondent and Dr. F. had a valid
supervisory agreement in place from August 22, 2019, to October 7,
2019, while both were employed at Nulton. The Agency further finds that
Dr. F. never supervised Respondent during that time period. Further, as
noted by the ALJ, there was no regular review of patient records, no
reports of Respondent's activities, and no channels of communication at
all between Respondent and Dr. F. RD, at 25.\11\ Dr. F. and Respondent
only ever spoke once, and that was prior to the time the Agreement was
entered.
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\11\ In his Exceptions, Respondent reiterates similar claims to
his hearing testimony such as: ``[t]here are cases where physician
assistants have operated under an implied supervising agreement and
where the specifics of such agreements were informally understood
rather than formally documented''; Respondent's lack of
communication with Dr. F. was ``actually reflective of broader
practices within the profession, where such supervisory
relationships are often more formal than substantive''; and ``[i]t
is a common practice for physician assistants to operate with
significant autonomy, despite what is often written in the formal
agreements.'' Exceptions, at 2. However, Respondent provided no
evidence to support these claims other than his testimony which has
already been considered, and which is inconsistent with Dr. F.'s
credible testimony as well as with Pennsylvania law. Id.; see also
RD, at 22 (citing 49 Pa. Code section 18.122 (``An appropriate
degree of supervision includes: (A) active and continuing overview
of the physician assistant's activities . . . (B) Immediate
availability of the supervising physician to the physician assistant
for consultations. (C) Personal and regular review within 10 days by
the supervising physician of the patient records upon which entries
are made by the physician assistant.'')); 49 Pa. Code section
18.158(a)(4) (``A physician assistant may only prescribe a drug for
a patient who is under the care of the physician responsible for the
supervision of the physician assistant.''), section 18.158(d)(4)
(``The supervising physician shall countersign the patient record
within 10 days.''), section 18.158(d)(3) (``The physician assistant
shall report, orally or in writing, to the supervising physician
within 36 hours, a drug prescribed or medication dispensed by the
physician assistant while the supervising physician was not
physically present . . . .). As discussed throughout this Decision,
Respondent's continued failure to provided supporting evidence for
his claims repeatedly detracts from his overall credibility as well
as the weight afforded to his unsupported statements.
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The Agency further finds that Respondent left Nulton in August of
2022. Thereafter, he issued 17 prescriptions to patients at a different
practice, PA Treatment Center, where Dr. F. did not work and would not
have access to the patient's records. It is undisputed that Respondent
was not covered by any supervisory agreement at the time those
prescriptions were issued. Even assuming Respondent truly believed that
his agreement with Dr. F. remained valid,\12\ the Agency, in agreement
with the ALJ, does not believe that Respondent held a reasonable belief
that he could rely on that agreement to issue prescriptions to patients
at a practice at which Dr. F. had never worked and after not speaking
with Dr. F. for over three years. RD, at 25. The Agency finds that
Respondent issued the relevant prescriptions independently.
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\12\ In his Exceptions, Respondent took issue with the ALJ's
``assumption that [Respondent] should have known about the
termination of his supervisory agreement'' and claimed that ``[t]he
ALJ's expectations were not in accordance with the legal
requirements of the state of Pennsylvania'' which, Respondent
alleges, ``require[ ] clear and direct communication regarding the
status of such agreements.'' Exceptions, at 3. Respondent provided
no evidence or citations to the law to support this claim. See supra
n.11. Regardless, as stated herein, the Agency finds that
Respondent, even if he believed the agreement remained valid, had no
reasonable belief that he could issue the relevant prescriptions
pursuant to that agreement under the circumstances.
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II. Discussion
A. The Five Public Interest Factors
Under the Controlled Substances Act (CSA), ``[a] registration . . .
to . . . dispense a controlled substance . . . may be suspended or
revoked by the Attorney General upon a finding that the registrant . .
. has committed such acts as would render his registration under
section 823 of this title inconsistent with the public interest as
determined under such section.'' 21 U.S.C. 824(a). In making the public
interest determination, the CSA requires consideration of the following
factors:
(A) The recommendation of the appropriate State licensing board
or professional disciplinary authority.
(B) The [registrant's] experience in dispensing, or conducting
research with respect to controlled substances.
(C) The [registrant's] conviction record under Federal or State
laws relating to the manufacture, distribution, or dispensing of
controlled substances.
(D) Compliance with applicable State, Federal, or local laws
relating to controlled substances.
(E) Such other conduct which may threaten the public health and
safety.
21 U.S.C. 823(g)(1).
The Agency considers these public interest factors in the
disjunctive. Robert A. Leslie, M.D., 68 FR 15227, 15230 (2003). Each
factor is weighed on a case-by-case basis. Morall v. Drug Enf't Admin.,
412 F.3d 165, 173-74 (D.C. Cir. 2005). Any one factor, or combination
of factors, may be decisive. David H. Gillis, M.D., 58 FR 37507, 37508
(1993).
The Government has the burden of proof in this proceeding. 21 CFR
1301.44. While the Agency has considered all of the public interest
factors in 21 U.S.C. 823(g)(1), the Government's evidence in support of
its prima facie case for revocation of Respondent's registration is
confined to Factors B and D. RD, at 15; see also id. at 15 n.33
(finding that Factors A, C, and E do not weigh for or against
revocation).
Having reviewed the record and the RD, the Agency agrees with the
ALJ, adopts the ALJ's analysis, and finds that the Government's
evidence satisfies its prima facie burden of showing that Respondent's
continued registration would be ``inconsistent with the public
interest.'' 21 U.S.C. 824(a)(4); RD, at 13-26.
B. Factors B and D
Evidence is considered under Public Interest Factors B and D when
it reflects compliance (or non-compliance) with laws related to
controlled substances and experience dispensing controlled substances.
See Sualeh Ashraf, M.D., 88 FR 1095, 1097 (2023); Kareem Hubbard, M.D.,
87 FR 21156, 21162 (2022). In the current matter, the Government has
alleged that Respondent violated numerous federal and state laws
regulating controlled substances. OSC, at 1-2. Specifically, federal
law requires that ``[a] prescription for a controlled substance to be
effective must be issued for a legitimate medical purpose by an
individual practitioner acting in the usual course of his professional
practice.'' 21 CFR 1306.04(a).\13\ As for
[[Page 71430]]
state law, Pennsylvania regulations provide that a physician assistant
may only perform medical services as approved within a written
agreement with a supervising physician; ``shall not independently
prescribe or dispense drugs''; and may not ``[p]rescribe or dispense
drugs except as described in the written agreement.'' 49 Pa. Code
section 18.152(a)(2); 63 Pa. Cons. Stat. section 422.13(a), (e), (f).
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\13\ The Agency need not adjudicate the criminal violations
alleged in the instant OSC. Ruan v. United States, 142 S. Ct. 2370
(2022) (decided in the context of criminal proceedings).
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In the current matter, the Agency agrees with the ALJ's analysis
that Respondent repeatedly issued controlled substance prescriptions
outside the usual course of professional practice by issuing such
prescriptions while lacking an active agreement with a supervisory
physician as required by state law. RD, at 17-18. Indeed, as noted by
the ALJ, Respondent failed to maintain any supervisee/supervisor
relationship, and with Dr. F. in particular, ``Respondent's failure to
communicate at all with [Dr. F.]--even when Respondent changed
employers--makes it hard to accept that Respondent truly believed he
still had an active supervisory agreement with [Dr. F.].'' Id. at
18.\14\
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\14\ In his Exceptions, Respondent argues that the ALJ's
``federal interpretation of Pennsylvania law is overly strict and
inconsistent with actual state practices,'' but fails to provide any
evidence supporting this claim other than noting the lack of action
against Respondent by the Pennsylvania state board of medicine.
Exceptions, at 2; see also id. at 4 (``[Respondent] maintains a
Pennsylvania state license, suggesting that the state regulatory
body did not find [his] actions sufficiently harmful to merit any
kind of sanction''). As mentioned above, the lack of state action
against Respondent was addressed by the ALJ in his analysis of
public interest Factor A. See RD, at 15 n.33. Respondent also claims
that ``the ALJ lacks the necessary expertise to interpret state-
specific legal standards correctly . . . [and] does not understand
the nuances of how supervising agreements are communicated and
understood in the context of Pennsylvania law, thereby leading to an
incorrect conclusion about [Respondent's] compliance.'' According to
Respondent, ``Pennsylvania law does not explicitly define the
frequency or nature of interaction required between a supervising
physician and a physician assistant. The law allows for varying
degrees of supervision, therefore the [ALJ] applied an unduly
stringent standard.'' Id. To these arguments, the Agency notes that
Respondent had ample opportunity in presenting his case-in-chief to
offer testimony from an expert witness regarding Pennsylvania
standards, but did not do so. The Agency also reiterates that
Respondent has repeatedly failed to provide citation to specific
Pennsylvania law. See supra n.5, 7, 11, 12. As such, the Agency, in
agreement with the ALJ, has considered the plain language of the
relevant Pennsylvania law and the record as a whole in making its
analysis.
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As Respondent's conduct displays clear violations of the federal
and state regulations described above, the Agency agrees with the ALJ
and hereby finds that Respondent repeatedly violated federal and state
law relating to controlled substances. Id. at 26. Accordingly, the
Agency agrees with the ALJ and finds that Factors B and D weigh in
favor of revocation of Respondent's registration and thus finds
Respondent's continued registration to be inconsistent with the public
interest in balancing the factors of 21 U.S.C. 823(g)(1). Id.\15\
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\15\ In his Exceptions, Respondent argues that there is no
evidence of any harm or abuse resulting from his prescribing at
issue. Exceptions, at 4. Agency precedent is clear that proof of
actual, subsequent harm is not required when a registrant has acted
inconsistently with the public interest. Melanie Baker, N.P., 86 FR
23998, 24009 (2021); Larry C. Daniels, M.D., 86 FR 61630, 61660-61
(2021); Jeanne E. Germeil, M.D., 85 FR. 73786, 73799 n.32 (2020).
Respondent also argues that revoking his registration ``is not in
the public interest, especially since he provides critical
specialized psychiatric care that is not easily replaceable.''
Exceptions, at 5. Nonetheless, ``[t]he CSA requires [the Agency] to
consider Respondent's controlled substance dispensing experience,
among other things, not whether Respondent's practice of medicine as
a whole [is] beneficial to the community.'' Brenton D. Wynn, M.D.,
87 FR 24228, 24258 n.KK (2022) (citing Frank Joseph Stirlacci, M.D.,
85 FR 45229, 45239 (2020) (declining to accept community impact
arguments); Richard J. Settles, D.O., 81 FR 64940, 64945 n.16
(2016)).
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III. Sanction
Where, as here, the Government has established sufficient grounds
to revoke Respondent's registration, the burden shifts to the
registrant to show why he can be entrusted with the responsibility
carried by a registration. Garret Howard Smith, M.D., 83 FR 18882,
18910 (2018). When a registrant has committed acts inconsistent with
the public interest, he must both accept responsibility and demonstrate
that he has undertaken corrective measures. Holiday CVS, L.L.C., dba
CVS Pharmacy Nos 219 and 5195, 77 FR 62316, 62339 (2012) (internal
quotations omitted). Trust is necessarily a fact-dependent
determination based on individual circumstances; therefore, the Agency
looks at factors such as the acceptance of responsibility, the
credibility of that acceptance as it relates to the probability of
repeat violations or behavior, the nature of the misconduct that forms
the basis for sanction, and the Agency's interest in deterring similar
acts. See, e.g., Robert Wayne Locklear, M.D., 86 FR 33738, 33746
(2021).\16\
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\16\ In his Exceptions, Respondent argues that ``[t]he
expectation of unequivocal acceptance of responsibility does not
consider the complexity of this individual case'' and asserts that
``it is reasonable and entirely appropriate for [Respondent] to
partially acknowledge fault while also presenting legitimate
explanations or mitigating factors for his actions. It is also
objectively true that [Respondent] has taken the steps necessary
already to ensure complete rectification and future compliance.''
Exceptions, at 4. The Agency has held repeatedly that ``[a]
registrant's acceptance of responsibility must be unequivocal, or
relief for sanction is not available, and where there is
equivocation any evidence of remedial measures is irrelevant.''
Fares Jeries Rabadi, M.D., 87 FR 30564, 30608 n.39 (2022) (citing
Daniel A. Glick, D.D.S., 80 FR 74800, 74801, 74810 (2015)); see also
Lon F. Alexander, M.D., 82 FR 49704, 49728 (2017) (collecting
cases).
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Here, and as noted by the ALJ, Respondent did admit some fault
regarding his use of auto-populated settings identifying Dr. M. as the
supervising physician during the relevant time despite the fact that
his written agreement with Dr. M. had been inactivated in December
2021. RD, at 27-28; Tr. 92-93. Respondent also acknowledged that his
agreement with Dr. F. was indeed inactivated in October 2019 based on
the termination letter introduced into evidence by the Government. RD,
at 28; Tr. 85-86; see GX 14. However, as noted by the ALJ, Respondent
repeatedly asserted that he believed that he was covered by his
agreement with Dr. F. when he issued the prescriptions at issue and
that he had not received notice of the inactivation of their agreement.
RD, at 28; Tr. 67-69, 81, 86, 98. Further, ``Respondent did not find
his lack of communication with [Dr. F.] as grounds for concern, and
indicated that he regularly treats patients without communicating with
a supervising physician.'' RD, at 28; Tr. 83-84, 96-97, 101-102.
Respondent ``further justified his conduct, testifying that patients
under his care were at risk of withdrawal effects had he ceased issuing
prescriptions.'' RD, at 28; Tr. 71-81. As the ALJ concluded, ``[t]his
explanation completely discounts the Respondent's responsibility to
transfer care to another practitioner when learning that he can no
longer provide the needed care, and further emphasizes the fact that
the Respondent was essentially operating as a solo practitioner with no
established relationship with a supervising physician who could assume
care.'' RD, at 28.
Notably, in his Exceptions, Respondent asserted that ``Pennsylvania
law regarding the supervision of physician assistants places the
responsibility of supervision on the supervising physician, not the
physician assistant.'' Exceptions, at 3 (citing 49 Pa. Code section
18.142; 63 Pa. Cons. Stat. section 422.13). Respondent also claimed
that ``[i]f the supervising physician fails to fulfill these
responsibilities, the fault does not lie with the PA, especially if the
PA was acting under the assumption of being properly supervised.'' Id.
Nowhere in the Pennsylvania law cited by Respondent does it appear to
place the sole responsibility on the supervising
[[Page 71431]]
physician for a physician assistant's actions. Moreover, this argument
demonstrates a blatant attempt by Respondent to shift the blame to his
supervising physician for his own failure to exercise basic due
diligence in staying apprised of whether an agreement critical to the
propriety of his work as a physician's assistant remained active.
Respondent also attempted to shift the blame to the PALS system,
stating in his Exceptions that ``[i]t is unreasonable to expect
[Respondent] not to consider the information in an official state
licensing portal accurate or to expect it to be error-prone. The
responsibility lies with the state to make sure the system is
functioning properly.'' Exceptions, at 3. As previously noted,
Respondent himself acknowledged that the PALS system can be inaccurate
regarding the dates for current agreements, see supra I.2; Tr. 64, and
once again, basic due diligence on the part of Respondent as well as
proper and ongoing communication with his supervising physician would
have ensured that Respondent would not have needed to rely solely on
PALS to know whether their supervising agreement remained active.
Ultimately, the ALJ concluded, and the Agency agrees, that
Respondent has not demonstrated unequivocal acceptance of
responsibility for his actions. Id. (citing Jones Total Health Care
Pharmacy, L.L.C. & SND Health Care, L.L.C., 81 FR 79188, 79201-02
(2016)).\17\
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\17\ When a registrant fails to make the threshold showing of
acceptance of responsibility, the Agency need not address the
registrant's remedial measures. Ajay S. Ahuja, M.D., 84 FR 5479,
5498 n.33 (2019) (citing Jones Total Health Care Pharmacy, 81 FR
79202-03); Daniel A. Glick, D.D.S., 80 FR 74800, 74801, 74,810
(2015). Even so, in the current matter, the ALJ noted, and the
Agency has considered, that Respondent is presently covered by a
written agreement with Dr. P. RD, at 28 n.44; Tr. 63-64; RX 1, at 3.
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In addition to acceptance of responsibility, the Agency considers
both specific and general deterrence when determining an appropriate
sanction. Daniel A. Glick, D.D.S., 80 FR 74810. In this case, the
Agency agrees with the ALJ that, regarding specific deterrence, ``there
is no reason to believe that the Respondent's behavior will not recur
in the future, as he failed to accept responsibility and repeatedly
attempted to justify his conduct.'' RD, at 29 (citing Gilbert Y. Kim,
D.D.S., 87 FR 21139, 21144-45 (2022)). Further, the Agency agrees with
the ALJ that the interests of general deterrence also support
revocation, as a lack of sanction in the current matter would send a
message to the registrant community that ``one can ignore the law and
yet incur no consequences from having done so.'' Id. at 29-30 (citing
Joseph Gaudio, M.D., 74 FR 10083, 10095 (2009)). Moreover, the Agency
agrees with the ALJ that Respondent's actions were egregious, as
Respondent issued seventeen controlled substance prescriptions to
multiple patients without an active written agreement in place with a
supervising physician. Id. at 29.\18\
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\18\ In his Exceptions, Respondent argues that ``even if it is
believed that [Respondent] is guilty of misconduct, that misconduct
. . . was not of a severity that warrants the extreme measure of
revocation.'' Exceptions, at 4. Respondent also claims, without
citing to any specific Agency precedent, that ``[s]imilar or more
severe violations have resulted in lesser punishments, such as
fines, reprimands, or temporary suspension'' and ``revocation would
represent an inconsistency in the application of penalties.'' Id.
The Agency possesses discretion to order a sanction lesser than
revocation, however, the Agency finds that ``exercising that
discretion here would ill-serve the public interest'' because
``Respondent has not shown that [he] can be entrusted with the
responsibility carried by [his] registration--having failed to
accept responsibility for [his] conduct, [the Agency has] no
assurance that Respondent would not repeat the conduct if [he was]
to retain a registration.'' The Pharmacy Place, 86 FR 21008, 21016
(2021).
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In sum, Respondent has not offered any credible evidence on the
record to rebut the Government's case for revocation of his
registration and Respondent has not demonstrated that he can be
entrusted with the responsibility of registration. Id. at 30.
Accordingly, the Agency will order that Respondent's registration be
revoked.\19\
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\19\ For his final Exception, Respondent argues that the ALJ's
removal restrictions are unconstitutional under Jarkesy v. SEC,
which held that the removal protections for ALJs of the Securities
and Exchange Commission (SEC) are unconstitutional (while declining
to decide whether that conclusion would entitle the plaintiff to
vacatur of the challenged agency decision). Jarkesy v. SEC, 34 F.4th
446, 463-465, 463 n.17 (5th Cir. 2022), aff'd on other grounds, SEC
v. Jarkesy, 603 U.S. __ (2024), No. 22-859 (June 27, 2024). Jarksey
was decided on the understanding that ``the SEC Commissioners may
only be removed by the President for good cause,'' and thus there
were ``two layers of insulation'' that ``impede[d] the President's
power to remove'' the SEC's ALJs. Id. at 464-465. By contrast, there
is no doubt that the President may remove the Attorney General at
will. Accordingly, Jarkesy can and should be distinguished from the
instant situation with respect to DEA's ALJs, and the Agency finds
Respondent's Exception to be unpersuasive.
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Order
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21
U.S.C. 824(a), I hereby revoke DEA Certificate of Registration No.
MM3329578 issued to Stephen McCarthy, P.A. Further, pursuant to 28 CFR
0.100(b) and the authority vested in me by 21 U.S.C. 823(g)(1), I
hereby deny any pending applications of Stephen McCarthy, P.A., to
renew or modify this registration, as well as any other pending
application of Stephen McCarthy, P.A., for additional registration in
Pennsylvania. This Order is effective October 3, 2024.
Signing Authority
This document of the Drug Enforcement Administration was signed on
August 19, 2024, by Administrator Anne Milgram. That document with the
original signature and date is maintained by DEA. For administrative
purposes only, and in compliance with requirements of the Office of the
Federal Register, the undersigned DEA Federal Register Liaison Officer
has been authorized to sign and submit the document in electronic
format for publication, as an official document of DEA. This
administrative process in no way alters the legal effect of this
document upon publication in the Federal Register.
Heather Achbach,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2024-19730 Filed 8-30-24; 8:45 am]
BILLING CODE 4410-09-P