Stephen McCarthy, P.A.; Decision and Order, 71427-71431 [2024-19730]

Agencies

• Drug Enforcement Administration
• Department of Justice

[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