[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]
BILLING CODE 4410-09-P