[Federal Register Volume 88, Number 159 (Friday, August 18, 2023)]
[Notices]
[Pages 56664-56666]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-17793]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 21-27]
William Tuong, M.D.; Decision and Order
On July 2, 2021, the Drug Enforcement Administration (DEA) issued
an Order to Show Cause (OSC) to William Tuong, M.D. (Respondent), of
Wilmington, Delaware. Request for Final Agency Action (RFAA), Exhibit
(RFAAX) 9, at 1, 7. The OSC proposed the revocation of Respondent's DEA
Certificate of Registration, Control No. BT1102653, alleging that
Respondent has ``committed such acts as would render [his] registration
inconsistent with the public interest.'' Id. at 1-2 (citing 21 U.S.C.
824(a)(4) and 823(g)(1) \1\).\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.
\2\ The Government represents that Respondent made a timely
hearing request. RFAA, at 1. Subsequently on October 28, 2021,
Respondent withdrew his hearing request and the proceedings were
terminated. RFAAX 10, at 1.
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The Agency makes the following findings of fact based on the
uncontroverted evidence submitted by the Government in its RFAA, which
was received by the Agency on January 30, 2023.
I. Findings of Fact
A. Investigation of Respondent
DEA's investigation of Respondent found that between August 30,
2017, and August 28, 2019, Respondent issued seven prescriptions for
56-84 tablets of methadone 10 mg, eight prescriptions for 168 tablets
of oxycodone \3\ 30 mg, and four prescriptions for 56 tablets of
oxymorphone 30 mg to a patient identified as Patient C.D. Declaration,
at 1-2; RFAAX 2. Further, DEA's investigation found that between March
30, 2017, and July 18, 2019, Respondent issued thirteen prescriptions
for 54-56 tablets of morphine sulfate \4\ 100 mg and fourteen
prescriptions for 135-168 tablets of oxycodone 30 mg to a patient
identified as Patient K.G. Declaration, at 1-2; RFAAX 3. Finally, DEA's
investigation found that between May 31, 2017, and August 22, 2018,
Respondent issued eighteen prescriptions for 168-174 tablets of
methadone 10 mg and eighteen prescriptions for 112-168 tablets of
oxycodone 30 mg to a patient identified as Patient J.W. Declaration, at
1-2; RFAAX 4.\5\
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\3\ The patient files for Patients C.D., K.G., and J.W. indicate
that Registrant prescribed Roxicodone, which is a brand name for
oxycodone. RFAA, Attachment 2 (hereinafter, Declaration), at 2 n.1;
see also RFAAX 2-4.
\4\ Specifically, Respondent prescribed MS Contin, a brand name
of morphine sulfate. Declaration, at 2 n.2.
\5\ Oxycodone, methadone, oxymorphone, and morphine are all
Schedule II controlled substances. 21 CFR 1308.12(b)(1)(ix),
(b)(1)(xiv), (b)(1)(xv), (c)(15).
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B. The Government Expert's Review of Respondent's Prescriptions
The DEA hired Dr. Aviva Fohrer, M.D., to opine on Respondent's
controlled substance prescribing based on, among other things, the
patient files described above (RFAAX 2-4) and medical records for the
patients in question that predated Respondent's treatment of the
patients. Declaration, at 1. The Agency finds that Dr. Fohrer is an
expert in the standard of care for prescribing controlled substances in
Delaware and gives her Declaration full credit in this Decision. See
RFAAX 5.
Prior to opining on each patient individually, Dr. Fohrer reviewed
the relevant prescriptions and described the standard of care for
prescribing controlled substances in Delaware. Declaration, at 2-4; see
also RFAAX 2-4; RFAAX 8. Regarding the standard of care, Dr. Fohrer
explained that ``[i]n addition to carefully justifying high-dose opioid
prescriptions, practitioners must also ensure that their patients give
valid informed consent prior to receiving these dangerous
prescriptions.'' Declaration, at 3. Dr. Fohrer noted that ``[o]f
special concern is methadone . . . [and] practitioners who prescribe
methadone should generally not combine it with other opioids, outside
of limited circumstances.'' Id. at 3-4. Dr. Fohrer also explained that
practitioners must monitor patients who receive high-dose opioids ``to
ensure they are not abusing or diverting controlled substances'' and
that such monitoring ``should involve checking the prescription drug
monitoring program (PDMP) reports and conducting urine drug screens.''
Id. at 3. Dr. Fohrer added that ``[w]here there are aberrant urine
screen results, practitioners must adequately address the results.''
Id. Finally, Dr. Fohrer explained that practitioners should
``periodically attempt to wean patients off high-dose opioid
prescriptions and discuss nonpharmacological and nonopioid
pharmacological alternatives.'' Id.
1. Patient C.D.
On August 30, 2017, Respondent began treatment of Patient C.D., who
was a pre-existing patient of Respondent's medical practice, and
continued Patient C.D.'s prescriptions, issuing prescriptions to
Patient C.D. for 56 tablets of methadone 10 mg and 168 tablets of
oxycodone 30 mg. Declaration, at 4; see also RFAAX 2, at 156. According
to Dr. Fohrer, ``[t]here was no justification in the medical record for
this high-dose opioid prescription'' nor was there ``any justification
for combining methadone with oxycodone.'' Id. Dr. Fohrer also noted
that Respondent ``did not obtain Patient C.D.'s informed consent prior
to issuing these dangerous prescriptions.'' Id.
Through at least August 28, 2019, Respondent continued to treat
Patient
[[Page 56665]]
C.D., and, as Dr. Fohrer stated, ``none of the issues identified with
the August 30, 2017, prescriptions were ever addressed.'' Id.
Additionally, Dr. Fohrer explained that there was ``never any attempt
to wean Patient C.D. off the high-dose opioids,'' nor did Respondent
``adequately monitor Patient C.D.'' or check the Delaware PDMP. Id.
Based on her expert medical opinion, Dr. Fohrer concluded, and the
Agency agrees, that ``all [nineteen] controlled substance prescriptions
that [Respondent] issued to Patient C.D. were issued outside the usual
course of professional practice for the state of Delaware.'' Id.
2. Patient K.G.
On March 30, 2017, Respondent began treatment of Patient K.G., who
was a pre-existing patient of Respondent's medical practice, and
continued Patient K.G.'s prescriptions, issuing prescriptions to
Patient K.G. for 56 tablets of morphine sulfate 100 mg and 168 tablets
of oxycodone 30 mg. Declaration, at 5; see also RFAAX 3. According to
Dr. Fohrer, ``[t]here was no justification in the medical record for
this high-dose opioid prescription.'' Id. Dr. Fohrer also noted that
Respondent ``did not obtain Patient K.G.'s informed consent prior to
issuing these dangerous prescriptions.'' Id.
Through at least August 15, 2019, Respondent continued to treat
Patient K.G., and, as Dr. Fohrer stated, ``none of the issues
identified on the March 30, 2017 prescriptions were ever addressed.''
Id. Additionally, Dr. Fohrer explained that there was ``never any
attempt to wean Patient K.G. off the medication,'' nor did Respondent
``adequately monitor Patient K.G.,'' or check the Delaware PDMP. Id.
Further, Dr. Fohrer stated that ``[e]ven more concerning, was
[Respondent's] failure to properly address aberrant urine drug
screens'' when, ``[o]n both October 12, 2017, and November 8, 2018,
Patient K.G. tested positive for methamphetamine, an illicit controlled
substance.'' Id. As Dr. Fohrer explained, ``[Respondent] fail[ed] to
address these signs of diversion.'' Id.
Based on her expert medical opinion, Dr. Fohrer concluded, and the
Agency agrees, that ``all [twenty-seven] controlled substance
prescriptions that [Respondent] issued to Patient K.G. were issued
outside the usual course of professional practice for the state of
Delaware.'' Id.
3. Patient J.W.
On May 31, 2017, Respondent began treatment of Patient J.W., who
was a pre-existing patient of Respondent's medical practice, and
continued Patient J.W.'s prescriptions, issuing prescriptions to
Patient J.W. for 168 tablets of methadone 10 mg and 168 tablets of
oxycodone 30 mg. Declaration, at 6; see also RFAAX 4. According to Dr.
Fohrer, ``[t]here was no justification in the medical record for this
high-dose opioid prescription'' nor was there ``any justification for
combining [the 'dangerous prescriptions' of] methadone with
oxycodone.'' Id. Dr. Fohrer also noted that Respondent ``did not obtain
Patient J.W.'s informed consent prior to issuing these dangerous
prescriptions.'' Id.
Through at least July 30, 2019, Respondent continued to treat
Patient J.W., and, as Dr. Fohrer stated, ``none of the issues
identified on the May 31, 2017 prescriptions were ever addressed.'' Id.
Dr. Fohrer explained that ``[t]here was also never any attempt to wean
Patient J.W. off the medication,'' nor did Respondent ``adequately
monitor Patient J.W.,'' or check the Delaware PDMP. Id.
Further, Dr. Fohrer stated that Respondent ``failed to adequately
address [ ] clear signs of abuse and medication diversion'' present in
Patient J.W.'s urine drug screen results. Id. Dr. Fohrer explained that
``[o]n June 27, 2018, Patient J.W. tested negative for all prescribed
controlled substances, an indication of diversion.'' Id. ``This urine
test was sent to a lab on June 28, 2018, and was confirmed negative for
all prescribed medications as well as positive for methamphetamines, an
illicit controlled substance.'' Id. Then, ``[o]n June 26, 2019, Patient
J.W. again tested positive for methamphetamines.'' Id. According to Dr.
Fohrer, ``[t]hese urine screens indicate that Patient J.W. was
diverting the medication prescribed to him and acquiring illicit
controlled substances.'' Id.
Based on her expert medical opinion, Dr. Fohrer concluded, and the
Agency agrees, that ``all [thirty-six] controlled substance
prescriptions that [Respondent] issued to Patient J.W. were issued
outside the usual course of professional practice for the state of
Delaware.'' Id. at 7; see also RFAAX 4.
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 applicant's experience in dispensing, or conducting
research with respect to controlled substances.
(C) The applicant'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 DEA 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).
While the Agency has considered all of the public interest factors
in 21 U.S.C. 823(g)(1),\6\ the Government's evidence in support of its
prima facie case for revocation of Respondent's registration is
confined to Factors B and D. See RFAA, at 7-9. Moreover, the Government
has the burden of proof in this proceeding. 21 CFR 1301.44.
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\6\ As to Factor A, there is no record evidence of disciplinary
action against Registrant's state medical license. 21 U.S.C.
823(g)(1)(A). State authority to practice medicine is ``a necessary,
but not a sufficient condition for registration . . . .'' Robert A.
Leslie, M.D., 68 FR at 15230. Therefore, ``[t]he fact that the
record contains no evidence of a recommendation by a state licensing
board does not weigh for or against a determination as to whether
continuation of [a registrant's] DEA certification is consistent
with the public interest.'' Roni Dreszer, M.D., 76 FR 19434, 19444
(2011). As to Factor C, there is no evidence in the record that
Registrant has been convicted of an offense under either federal or
state law ``relating to the manufacture, distribution, or dispensing
of controlled substances.'' 21 U.S.C. 823(g)(1)(C). However, as
Agency cases have noted, there are a number of reasons why a person
who has engaged in criminal misconduct may never have been convicted
of an offense under this factor, let alone prosecuted for one. Dewey
C. MacKay, M.D., 75 49956, 49973 (2010). Agency cases have therefore
found that ``the absence of such a conviction is of considerably
less consequence in the public interest inquiry'' and is therefore
not dispositive. Id. As to Factor E, the Government's evidence fits
squarely within the parameters of Factors B and D and does not raise
``other conduct which may threaten the public health and safety.''
21 U.S.C. 823(g)(1)(E). Accordingly, Factor E does not weigh for or
against Registrant.
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Here, the Agency finds that the Government's evidence satisfies its
prima facie burden of showing that Respondent's continued registration
[[Page 56666]]
would be ``inconsistent with the public interest.'' 21 U.S.C. 824(a).
The Agency further finds that Respondent failed to provide sufficient
evidence to rebut the Government's prima facie case.
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). The Government has alleged that Respondent's
prescribing practices violated both federal and Delaware state law.
RFAAX 9, at 2-6. According to the CSA's implementing regulations, a
lawful controlled substance order or prescription is one that is
``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, Delaware law requires that ``[a] prescription for
a controlled substance must be issued for a legitimate medical purpose
by practitioner[s] acting in the usual course of their professional
practice.'' 24 Del. Admin. Code CSA section 4.2.1.\7\ Delaware law
lists the requirements for the safe prescribing of opioid
analgesics,\8\ including that physicians must: obtain an Informed
Consent form signed by the patient that includes information regarding
the drugs potential for addiction, abuse, and misuse; query the
Delaware Prescription Monitoring Program at least every six months for
pain patients; document in a pain patient's medical record
``alternative treatment options that have been tried by the patient,
including non-pharmacological treatments, and their adequacy with
respect to providing sufficient management of pain.'' Id. sections
9.6.4, 9.8.1, 9.8.6. Delaware law also states that ``[s]pecial
attention must be given to those patients with pain who are at risk for
medication misuse, abuse or diversion.'' 24 Del. Admin. Code 1700
section 18.6. Finally, Delaware law defines actions by a practitioner
subject to sanction to include the ``fail[ure] to maintain effective
controls against diversion of controlled substances into other than
legitimate medical, scientific or industrial channels.'' Del. Code tit.
16, section 4735(b)(1).
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\7\ Delaware law also provides that ``[a] prescription may not
be issued for the dispensing of narcotic drugs listed in any
schedule to a person engaged in substance abuse or misuse . . . for
the purpose of continuing such person's dependence upon such drugs,
unless otherwise authorized by law.'' Id. section 4.2.3.
\8\ Delaware law defines an ``opioid analgesic'' as ``a drug
that is used to alleviate moderate to severe pain that is either an
opiate (derived from the opium poppy) or opiate-like (synthetic
drugs).'' Id. section 9.3. Delaware law includes methadone and
morphine as specific examples of opioid analgesics. Id.
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Based on the credible and unrebutted opinion of the Government's
expert, the Agency found above that Respondent's prescribing of the
relevant controlled substance prescriptions to Patients C.D., K.G., and
J.W. was outside the usual course of professional practice for the
state of Delaware. See supra I.B. Specifically, Respondent gave no
justification in the patients' medical records for issuing high-dose
opioid prescriptions; did not obtain the patients' informed consent
prior to issuing such prescriptions; made no attempt to wean the
patients off such prescriptions, offer nonpharmacologic therapies, or
offer alternative, nonopioid medications; and failed to adequately
monitor the patients, with Respondent failing to check the Delaware
PDMP. Id. Further, with regards to Patients C.D. and J.W., Respondent
gave no justification for combining methadone with oxycodone, while
with regards to Patients K.G. and J.W., Respondent failed to properly
address aberrant urine drug screens that indicated both diversion and
use of illicit controlled substances. Id.
In sum, the Agency finds that the record contains substantial
evidence that Respondent prescribed 82 controlled substances in
violation of both federal law, 21 CFR 1306.04, and state law, 24 Del.
Admin. Code CSA sections 4.2.1, 9.6.4, 9.8.1, and 9.8.6. The Agency,
therefore, finds that Factors B and D weigh in favor of revocation of
Respondent's registration and thus finds Respondent's 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 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).
Here, although Respondent initially requested a hearing, he
withdrew his hearing request and did not otherwise avail himself of the
opportunity to refute the Government's case. As such, Respondent has
made no representations as to his future compliance with the CSA nor
made any demonstration that he can be trusted with a registration. The
evidence presented by the Government clearly shows that Respondent
violated the CSA and indicates that he cannot be entrusted.
Accordingly, the Agency will order the revocation of Respondent's
registration.
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.
BT1102653 issued to William Tuong, M.D. 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 William Tuong, M.D., to renew
or modify this registration, as well as any other pending application
of William Tuong, M.D., for additional registration in Delaware. This
Order is effective September 18, 2023.
Signing Authority
This document of the Drug Enforcement Administration was signed on
August 14, 2023, 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. 2023-17793 Filed 8-17-23; 8:45 am]
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