[Federal Register Volume 89, Number 125 (Friday, June 28, 2024)]
[Notices]
[Pages 54047-54051]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-14195]
[[Page 54047]]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 22-54]
Michael Gore, P.A.; Decision and Order
On August 26, 2022, the Drug Enforcement Administration (DEA or
Government) issued an Order to Show Cause (OSC) to Michael Gore, P.A.,
(Respondent) of Staten Island, New York. OSC, at 1, 8. The OSC proposed
the revocation of Respondent's DEA Certificate of Registration, Control
No. MG1185277, alleging that Respondent's continued registration is
inconsistent with the public interest. Id. at 1 (citing 21 U.S.C.
823(g)(1),\1\ 824(a)(4)), 2.
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\1\ Effective December 2, 2022, the Medical Marijuana and
Cannabidiol Research Expansion Act, Public Law 117-215, 136 Stat.
2257 (2022) (Marijuana Research Amendments or MRA), amended the
Controlled Substances Act (CSA) and other statutes. Relevant to this
matter, the MRA redesignated 21 U.S.C. 823(f), cited in the OSC, as
21 U.S.C. 823(g)(1). Accordingly, this Decision cites to the current
designation, 21 U.S.C. 823(g)(1), and to the MRA-amended CSA
throughout.
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A hearing was held before DEA Administrative Law Judge Paul E.
Soeffing (ALJ), who, on September 8, 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 45. Respondent did not file
Exceptions to the RD. 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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\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 2-22. 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, was generally consistent, without indication
of any animosity towards Respondent, and thus was fully credible and
warranted substantial weight. Id. at 4-5. The Agency also agrees
with the ALJ that the testimony from the DEA Special Agent (SA),
which was primarily focused on the introduction of the Government's
documentary evidence and how the undercover visits were conducted,
was generally consistent, without indication of any animosity
towards Respondent, and thus was fully credible and warranted
substantial weight. Id. at 8. Finally, the Agency agrees with the
ALJ that the testimony from the Government's expert witness, Dr.
Brian Durkin, D.O., which was focused on the New York standard of
care and Respondent's prescribing to the Undercover Officer,
presented an objective analysis that was internally consistent,
logically persuasive, credible, reliable, and warranted significant
weight. Id. at 22.
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I. Findings of Fact
New York Standard of Care
Dr. Brian Durkin, D.O., testified for the Government as an expert
in the area of pain management and the standard of care for prescribing
controlled substances in the state of New York. RD, at 9; Tr. 367.\3\
Dr. Durkin practices as an anesthesiologist and pain management
specialist and testified that his expert opinion regarding the standard
of care in this case is informed by his experiences, the experiences of
his colleagues (including physicians and advanced practice providers),
and the medical societies that he participates in or leads. RD, at 8,
13; Tr. 363, 499.\4\ Dr. Durkin also testified that New York has
codified the standards for the prescribing of opioids. RD, at 13; Tr.
500.
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\3\ On cross-examination, Dr. Durkin testified that the standard
of care varies geographically based on the specialists available to
patients that live in a given locality; nonetheless, all
practitioners in New York are required to complete an opioid
prescribing course every two years that establishes guidelines for
prescribing opioids in New York. RD, at 12-13; Tr. 497-98, 501-02.
When asked to clarify his testimony regarding a regional standard of
care, Dr. Durkin testified that the regional aspect was confined to
the availability of specialists, and provided as an example that a
general practitioner could be competent to deliver a baby in a rural
community without obstetricians but is likely not competent and
should not offer obstetric services in an urban environment with
many local obstetricians. RD, at 13 n.21; Tr. 554-56. Regarding the
current matter, Dr. Durkin opined that Respondent's care fell below
the standard of care in every New York region and community
``because nothing was ever done to address the problem or make a
correct diagnosis,'' as required throughout the state. RD, at 13
n.21; Tr. 556-57.
\4\ For Dr. Durkin's full qualifications, see Government Exhibit
(GX) 19; RD, at 8-9.
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According to Dr. Durkin, under the standard of care in New York, a
practitioner must establish a patient and provider relationship to
prescribe controlled substances and must have a legitimate medical
reason to prescribe opioids. RD, at 9; Tr. 368, 383. Further, the
practitioner must form a diagnosis and treatment plan after reviewing
the patient's full medical history,\5\ conducting a physical
examination, and ordering any necessary tests or referring the patient
to a specialist. RD, at 9; Tr. 368, 370-71. Dr. Durkin explained that a
proper physical examination requires an initial observation of the
patient's presentation and functionality, followed by a targeted
physical examination related to the patient's pain complaint, including
tests aimed at diagnosing specific causes of pain. RD, at 10; Tr. 377-
78, 494-95, 550. According to Dr. Durkin, a physical examination should
be conducted during every encounter, including initial visits, follow-
up visits, telehealth visits, and in-person visits. RD, at 10; Tr. 384.
Dr. Durkin testified that an in-person physical examination is more
involved than a virtual examination, but the physician can still
examine the patient virtually, for example, by listening to the
patient's voice to see if his words are slurred and observing the
patient's state of mind. RD, at 10, 20; Tr. 383-84, 419-20.
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\5\ Dr. Durkin testified that a full medical history includes
past medical history, past surgical history, a social history, and
family history; a full medical history also sometimes focuses on a
particular part of the body depending on the complaint of pain, but
is always aimed at assessing a patient's overall health. RD, at 9;
Tr. 369-70. Dr. Durkin also testified that a practitioner needs
records from previous treating providers to make sure that the
treatment is not repetitive and to make sure that the patient is
treated safely, effectively, and cost effectively. RD, at 9 n.18;
Tr. 370.
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Regarding documentation, Dr. Durkin testified that the standard of
care requires that practitioners document history and physical
examinations in patient records to: 1) guide the diagnosis, treatment
plan, and any decisions about diagnostic testing; 2) make the patient's
care more efficient and cost-effective; and 3) generate a robust record
for future providers. RD, at 11; Tr. 378-81. Dr. Durkin also noted that
the standard of care requires that practitioners not falsify patient
records. RD, at 9-10; Tr. 549-50.
Regarding the prescribing of opioids to treat pain, Dr. Durkin
testified that opioids may be the first line of treatment for acute or
severe pain, such as pain following surgery, provided that they are
prescribed for no more than three to seven days. RD, at 11; Tr. 368. In
contrast, with chronic pain lasting three months or more, there are
other modalities that are safer and more effective than opioid therapy.
Id. These modalities should be assessed based on their level of
invasiveness and risk. RD, at 11; Tr. 369. Dr. Durkin explained that if
less-invasive options, such as surgery and physical therapy, have
failed, the practitioner should begin medication management with the
less risky medications, such as anti-inflammatory drugs and muscle
relaxants. RD, at 11; Tr. 369, 371-72, 405. If all of these options
fail, then a practitioner may consider opioid therapy, but the
practitioner needs to weigh the risks (ranging from mild issues to
death) and benefits to the patient. Id.
Dr. Durkin testified that prior to beginning opioid therapy, the
physician must obtain informed consent by discussing the risks and
benefits of treatment. RD, at 12; Tr. 374-75, 405. Informed consent
typically involves a written agreement, signed by the patient (and a
witness), that outlines the risks, benefits, rules, and guidelines of
opioid treatment, as well as compliance
[[Page 54048]]
measures that will be utilized to prevent diversion and abuse, such as
urinalysis and pill counts. RD, at 12, 13; Tr. 374-76, 405, 469-71. Dr.
Durkin testified that a prescriber must also review a patient's I-STOP
\6\ data, history of addiction and substance abuse, and family history
of addiction before prescribing opioids. RD, at 12; Tr. 372-74.
Finally, practitioners must address any red flags of abuse or diversion
to ensure that the medications that they prescribe are being used
safely and legitimately. RD, at 19; Tr. 413-14.
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\6\ I-STOP, New York's Prescription Monitoring Program, includes
a record of controlled substances prescribed to a patient in New
York. RD, at 6 n. 12, 12; Tr. 372-73. This data is analyzed to
ensure that patients are not doctor shopping or receiving opioids
from multiple providers. RD, at 12; Tr. 383.
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Regarding follow-up visits, Dr. Durkin testified that a provider
must assess the effectiveness of the treatment plan, including, (1)
whether the patient has tried alternative therapies such as physical
therapy, (2) how the patient is progressing in the treatment plan, and
(3) the efficacy of any prescribed medications as well as any side
effects. RD, at 19-20; Tr. 418-19. For opioid medications in
particular, the provider must also conduct an ongoing risk assessment,
document functional improvements, and determine whether weaning off or
increasing the medication is needed. Id.
Respondent's Treatment of the Undercover Officer
March 11, 2021 Visit
Dr. Durkin reviewed audiovisual recordings of the interactions
between Respondent and an Undercover Officer (UC), transcripts of the
recordings, the UC's medical records, and the prescription history for
the UC. RD, at 13; Tr. 387, 469. The UC first visited Respondent on
March 11, 2021, complaining of shoulder pain. RD, at 15; Tr. 388-89,
493; GX 2; GX 3, at 4. The UC reported having pain for ten years, that
he had not had any diagnostic imaging done, and that he took his
girlfriend's oxycodone because she had insurance. RD, at 15; Tr. 389;
GX 1, at 1; GX 2; GX 3, at 4.
Dr. Durkin testified that a physician acting within the standard of
care would have made a diagnosis and developed a treatment plan (as
described above), after conducting a focused physical examination of
the UC's cervical spine, shoulders, and upper extremities, and ordering
imaging of those areas. RD, at 15; Tr. 390-91.\7\ Respondent documented
a very thorough physical examination of the UC--including a full
vascular, muscular, and neurological examination and range of motion
testing--but Dr. Durkin's review of the video recording revealed that
the actual physical examination that Respondent performed was ``[not]
anywhere close to what [was] documented in the medical record.'' RD, at
17; Tr. 400; GX 1, at 2-4. According to Dr. Durkin, Respondent's
examination of the UC appeared to take about twelve seconds, whereas
the examination documented in the medical file would have taken a
neurologist ten or fifteen minutes to complete. RD, at 17; Tr. 400-01;
GX 2; GX 3, at 6. Moreover, while there was a documented pain score in
the record, Dr. Durkin saw ``no indication that there was a pain score
asked [about] during the audio visual or in the transcripts.'' Tr. 402;
see also RD, at 17; GX 1, at 2; GX 2; GX 3, at 3-11. As such, Dr.
Durkin concluded that the notes in the UC's patient file do not
accurately reflect what happened during the March 11, 2021 visit. RD,
at 17; Tr. 401.
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\7\ On cross-examination, Dr. Durkin was asked how an uninsured
patient can afford diagnostic imaging. RD, at 15 n.26; Tr. 509-15.
Dr Durkin testified that Respondent could have helped the UC find an
affordable Medicaid plan that would cover imaging or could have
referred the UC to a university hospital for free or low-cost
imaging and ``charity care.'' Id.
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Regarding Respondent's patient notes from this visit, Dr. Durkin
testified that the ``Past Medical/Surgical History'' section should
have detailed any chronic medical problems and past surgeries; however,
this section in the UC's medical file is blank. RD, at 16; Tr. 391.
Further, based on the recording of this visit, Respondent did not ask
the UC about his medical or surgical history, did not request any
medical files or imaging studies from previous providers, and did not
order any diagnostic imaging. RD, at 16; Tr. 391-93; GX 1; GX 2; GX 3,
at 3-10. Dr. Durkin testified that this is ``Medicine 101'' and that
the ``heart and soul of medicine is getting a history, a physical
examination, and confirmation with testing.'' RD, at 16; Tr. 392-93.
Regarding a patient's history in particular, providers need to know
what treatments the patient has tried, whether they have worked, and
whether non-opioid medications have been trialed. RD, at 16; Tr. 392-
394, 396.\8\
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\8\ On cross-examination, when asked about the UC having a
fictious identity with no prior medical history or records, Dr.
Durkin opined that this lack of history and records should have
generated additional red flags of abuse or diversion. RD, at 16
n.27; Tr. 502-04.
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As for the ``Medications'' and ``Allergies'' sections of
Respondent's patient notes from the initial visit, Dr. Durkin noted
that these sections are blank in the UC's medical file despite the UC
telling Respondent: (1) that he had been taking oxycodone 20 mg (which
was prescribed to his girlfriend) several times a day; and (2) that he
is allergic to penicillin and sulfa antibiotics. RD, at 16; Tr. 395-
398, 549; GX 1, at 1-2; GX 2; GX 3, at 4-5. As for the ``Social
History'' section, Dr. Durkin testified that Respondent did not ask the
UC about his history of smoking or alcohol during the initial visit but
Respondent documented that the UC does not use alcohol or tobacco. RD,
at 16; Tr. 398; GX 1, at 2; GX 2; GX 3, at 11. Further, despite the UC
reporting his use of oxycodone (not prescribed to him) three weeks
prior to the visit, the ``Social History'' section indicates that the
UC was not using drugs. RD, at 16; Tr. 399-400; GX 1, at 2; GX 2; GX 3,
at 4.
Regarding the ``Assessment'' section of the UC's patient file, Dr.
Durkin testified that this is where the ``working diagnosis'' should be
located. RD, at 17-18; Tr. 403. For a patient complaining of chronic
shoulder pain, Dr. Durkin explained that an appropriate diagnosis based
solely on a history and physical examination would be chronic shoulder
pain or acute shoulder pain. RD, at 18; Tr. 403. However, Respondent
documented that the UC had a herniated disc and lumbar radiculopathy,
which are diagnoses that cannot be made without imaging, or justified
by the limited physical examination that Respondent conducted; Dr.
Durkin therefore concluded that these assessments do not make sense.
RD, at 18, 20; Tr. 403-04, 423-24; GX 1, at 4. Dr. Durkin further noted
that while the UC only complained of shoulder pain, the ``Assessment''
section references back and leg pain with no mention of shoulder pain
or a working diagnosis related to the shoulder pain. RD, at 18; Tr.
404. As such, Dr. Durkin concluded that no steps were taken to hone in
on an actual diagnosis. Id.
Overall, Dr. Durkin opined that Respondent's prescribing of 90
tablets of oxycodone 10 mg to the UC on the UC's initial March 11, 2021
visit was ``clearly outside the bounds of legitimate prescribing of
opioids.'' RD, at 19; Tr. 408; see GX 1, at 4. Dr. Durkin testified
that Respondent's diagnosis of the UC did not resemble the UC's
complaint or justify opioid therapy, despite Respondent's attempts to
generate inaccurate paperwork to justify the prescribing. Id. Dr.
Durkin further testified that issuing an opioid prescription without an
established diagnosis is outside the standard of care and that the
oxycodone prescription issued to the UC was not issued for a legitimate
medical purpose by a
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practitioner acting within the normal course of professional practice.
RD, at 19; Tr. 408-09, 415. Dr. Durkin noted that the UC presented
himself as a high-risk patient by admitting to using opioids that were
not prescribed to him, as well as presenting with other concerning
factors such as his age and lack of documented treatment history, yet
Respondent failed to conduct a sufficient risk assessment. RD, at 19;
Tr. 409-11. Additionally, Respondent completely ignored red flags of
abuse and diversion and therefore disregarded the risks associated with
prescribing oxycodone to the UC. Id. Dr. Durkin also testified that
Respondent failed to obtain informed consent from the UC for
prescribing opioids because he failed to discuss the risks of opioids,
possible interactions with other substances, and proper storage and
disposal, and failed to advise the UC to discontinue the opioids if
they were not effective. RD, at 18-19; Tr. 405-406.\9\
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\9\ On cross-examination, Dr. Durkin was asked whether his
opinions would change if the UC had filled out an intake form or
pain management agreement that was not included in the files that he
reviewed. RD, at 14-15; Tr. 469, 474-76, 479-80, 534-35, 546-49,
551-53, 481-87. Dr. Durkin testified that these documents would not
change his opinions. Id. Although intake forms can be a good
starting point to initiate a patient visit, they do not absolve a
physician of the duty to have the necessary discussions with his
patient to establish a diagnosis or treatment plan. RD, at 14-15;
Tr. 479-80, 534-35. And if a patient had filled out a pain
management agreement prior to the visit that the physician did not
discuss with the patient during the visit, it would generate an
additional red flag because it would indicate that the practice was
prescribing opioids readily. RD, at 15; Tr. 548, 552-53. Moreover,
the Agency may infer from Respondent's failure to produce these
forms that they would not be supportive of his case. Pharmacy Drs.
Enters., 83 FR 10876, 10899 (2018) (``[W]hen a party has relevant
evidence within his control which he fails to produce, that failure
gives rise to an inference that the evidence is unfavorable to
him.''); UAW v. NLRB, 459 F.2d 1329, 1338 (D.C. Cir. 1972);
Huthnance v. DC, 722 F.3d 371, 378 (D.C. Cir. 2013).
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Follow-Up Visits (April 2021-October 2021)
Regarding the UC's follow-up visit to Respondent on April 8, 2021,
Dr. Durkin testified that he would expect to see in the ``History of
Present Illness'' section of the medical file an assessment of the UC's
functional gains and improvements related to the treatment plan,
whether the UC's condition had worsened, and how the UC was doing since
the last visit. RD, at 20; Tr. 420-21. However, Dr. Durkin testified
that the visit was very brief, lasting approximately one minute, and
Respondent's examination of the UC was only ``a quick look at the
patient as he popped his head in the room.'' RD, at 20; Tr. 420. Dr.
Durkin testified that despite this, the notes in the ``History of
Present Illness'' section are, again, far more extensive than what
actually occurred during the visit and the patient record does not
accurately reflect the visit. RD, at 20; Tr. 421-22; GX 1, at 6-9; GX
4, GX 5, at 1-2. According to Dr. Durkin, although the patient file
indicates that a thorough examination and pain assessment took place,
including notes of symptoms that were not discussed, the actual April
8, 2021 visit only consisted of a ``how are you doing, we'll see you
next month[,] . . . I'll send in your prescription refills.'' RD, at
20; Tr. 421-22; GX 1, at 6-8; GX 4; GX 5, at 1-2. In addition to
continuing to include the unsupported diagnoses of herniated discs and
lumbar radiculopathy, the medical records also falsely indicate that
Respondent checked I-STOP, executed an opioid agreement with the UC,
discussed physical therapy, and reviewed the pain management policies
of Respondent's practice, as well as the expectations of opioid
treatment and treatment goals. RD, at 20-21; Tr. 423-26; GX 1, at 9; GX
4; GX 5, at 1-2.
Dr. Durkin testified that Respondent did not obtain the UC's
informed consent for continued opioid treatment and that Respondent
could not have adequately examined the UC to justify prescribing
opioids during this one-minute visit. RD, at 21; Tr. 424, 426-27.
Ultimately, Dr. Durkin opined that the prescription for 90 tablets of
oxycodone 10 mg issued by Respondent to the UC on April 8, 2021, was
not issued for a legitimate medical purpose by a practitioner acting
within the normal course of professional practice. RD, at 21; Tr. 427;
see GX 1, at 9.
Regarding the UC's approximately monthly follow-up visits (both in-
person and via telehealth) to Respondent through October 2021, Dr.
Durkin again observed concerning deficiencies and contradictions
between the recordings and the medical records similar to his concerns
with the initial visit. RD, at 21-22; Tr. 427-462; GX 1, at 10-26; GX
6; GX 7, at 1-3; GX 8; GX 9, at 1-2; GX 10; GX 11; GX 12; GX 13, at 1-
5; GX 14; GX 15; see also GX 17, at 1, 5, 6, 9, 10, 12. Ultimately, Dr.
Durkin opined that the prescriptions issued by Respondent to the UC,
each for 90 tablets of oxycodone 10 mg, were not issued for a
legitimate medical purpose by a practitioner acting within the normal
course of professional practice. RD, at 21-22.
In sum, based on his review of the recordings and the related
medical records of the UC's visits with Respondent, Dr. Durkin opined
that all of the prescriptions issued by Respondent to the UC for
oxycodone were not issued for a legitimate medical purpose by a
practitioner acting within the normal course of professional practice.
RD, at 22; Tr. 461. Dr. Durkin further opined that Respondent's
prescribing of oxycodone to the UC was likely to cause harm to the UC
and fell below the standard of care for a practitioner in New York. RD,
at 22; Tr. 462.
Respondent offered no testimony or documentary evidence and did not
present a case-in-chief. RD, at 22.
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 25; see also id. at 25 n.32
(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,
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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 22-41.
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/ISO, 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).\10\ As for state law, New York
regulations also provide that a controlled substance may only be
prescribed by ``[a] practitioner, in good faith, and in the course of
his or her professional practice.'' N.Y. Pub. Health Law section
3331(2); \11\ see also N.Y. Comp. Codes R. & Regs. tit. 10, sections
80.62(a) (practitioners ``in the course of their professional practice,
may dispense, administer or prescribe controlled substances for
legitimate medical purposes or treatment . . . ''), 80.65
(prescriptions for controlled substances ``shall be issued for
legitimate medical purposes only''), 94.2(e)(2) (a physician assistant
may only prescribe controlled substances ``in good faith and acting
within his or her lawful scope of practice''). Further, New York state
law provides that a practitioner's license ``may be revoked . . . in
whole or in part upon a finding that the licensee or certificate holder
has . . . falsified any [required] application, report, or record'' or
``failed to maintain effective control against diversion of controlled
substances . . . .'' N.Y. Pub. Health Law section 3390(1), (5).
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\10\ The Agency need not adjudicate the criminal violations
alleged in the instant OSC/ISO. Ruan v. United States, 142 S. Ct.
2,370 (2022) (decided in the context of criminal proceedings).
\11\ A ``practitioner'' is defined as ``[a] physician . . . or
other person licensed, or otherwise permitted to dispense,
administer or conduct research with respect to a controlled
substance in the course of a licensed professional practice . . .
.'' N.Y. Pub. Health Law section 3302(27).
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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 and not for a
legitimate medical purpose because, as detailed above, Respondent
failed to adequately examine, evaluate, and diagnose the UC to
medically justify prescribing him controlled substances, and failed to
address red flags of abuse and/or diversion before issuing the
prescriptions. RD, at 27-28. Further, Respondent repeatedly and
egregiously falsified the UC's medical records, documenting physical
examinations, compliance measures, and patient-doctor discussions that
did not occur. Id. 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. RD, at 41.
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).
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,
18904 (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). 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).
Here, although Respondent requested a hearing and submitted a
prehearing statement, Respondent ultimately offered no testimony or
documentary evidence and did not present a case-in-chief. Respondent's
failure to demonstrate any remorse for his actions or offer any
assurances about his future compliance weigh strongly against continued
registration because his conduct did much to diminish his credibility
with the Agency.
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 74800, at 74810 (2015). In
this case, the Agency agrees with the ALJ that the interests of
specific deterrence weigh in favor of revoking Respondent's
registration. RD, at 44; GX 1-17. 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 prescribing controlled substances without
conducting and documenting even the most basic treatment-related
evaluations and examinations can be overlooked or excused. RD, at 44.
Moreover, the Agency agrees with the ALJ that Respondent's actions
were egregious. Id. at 43-44. Not only did Respondent fail to complete
all of the necessary components of a proper medical examination to
justify the prescribing of opioids, he flagrantly falsified the UC's
medical record presumably to evade government scrutiny. Notably,
Respondent documented a detailed evaluation and examination of the UC
that did not occur. Id. at 44. This indicates that Respondent was well
acquainted with his professional and legal obligations, yet chose to
disregard them, despite the serious dangers the prescribed controlled
substances posed to the UC, an admitted abuser, and the community.
Further, Respondent fabricated diagnoses that were neither tied to the
UC's initial complaint nor supported by any imaging that would be
necessary to reach such diagnoses. In this case, the Agency believes
that revocation of Respondent's registration would deter Respondent and
encourage the general registrant community to take caution when
prescribing controlled substances and ensure that their medical records
are thorough and accurate.
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. RD, at 45.
Accordingly, the Agency will order that Respondent's registration be
revoked.
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.
MG1185277 issued
[[Page 54051]]
to Michael Gore, 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 Michael Gore, P.A., to renew or modify this
registration, as well as any other pending application of Michael Gore,
P.A., for additional registration in New York. This Order is effective
July 29, 2024.
Signing Authority
This document of the Drug Enforcement Administration was signed on
June 21, 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. 2024-14195 Filed 6-27-24; 8:45 am]
BILLING CODE 4410-09-P