[Federal Register Volume 89, Number 36 (Thursday, February 22, 2024)]
[Notices]
[Pages 13376-13379]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-03548]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Henry Manning Pickett, M.D.; Default Decision and Order

    On July 10, 2023, the Drug Enforcement Administration (DEA or 
Government) issued an Order to Show Cause and Immediate Suspension of 
Registration (OSC/ISO) to Henry Manning Pickett, M.D., (Respondent) of 
Lakewood, Colorado. Request for Final Agency Action (RFAA), Exhibit 
(RFAAX) 1, at 1. The OSC/ISO informed Respondent of the immediate 
suspension of his DEA Certificate of Registration, Control No. 
AP1388948, pursuant to 21 U.S.C. 824(d), alleging that Respondent's 
continued registration constitutes `` `an imminent danger to the public 
health or safety.' '' Id. (quoting 21 U.S.C. 824(d)). The OSC/ISO also 
proposed the revocation of Respondent's registration, alleging that 
Respondent's continued registration is inconsistent with the public 
interest. Id. (citing 21 U.S.C. 823(g)(1), 824(a)(4)).
    The OSC/ISO notified Respondent of his right to file with DEA a 
written request for hearing within 30 days after the date of receipt of 
the OSC/ISO; the OSC/ISO also notified Respondent that if he failed to 
file such a request, he would be deemed to have waived his right to a 
hearing and be in default. Id. at 8-9 (citing 21 CFR 1301.43). Here, 
Respondent filed an untimely request for hearing on August 17, 2023,\1\ 
and within his request for hearing, failed to answer the allegations 
contained in the OSC/ISO as required by 21 CFR 1301.43. See RFAAX 3. On 
August 17, 2023, Chief Administrative Law Judge John J. Mulrooney, II, 
(the Chief ALJ) issued an Order requiring Respondent to, among other 
things, answer the allegations by August 23, 2023. See RFAAX 4. 
Respondent failed to file answers to the allegations or to otherwise 
respond to the order. Ultimately, the Chief ALJ determined that 
Respondent was in default, and on August 28, 2023, issued an Order 
Terminating Proceedings. See RFAAX 5. ``A default, unless excused, 
shall be deemed to constitute a waiver of the registrant's/applicant's 
right to a hearing

[[Page 13377]]

and an admission of the factual allegations of the [OSC].'' 21 CFR 
1301.43(e).
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    \1\ Based on the Government's submissions in its RFAA dated 
August 29, 2023, the Agency finds that service of the OSC/ISO on 
Registrant was adequate and rendered on July 11, 2023. Specifically, 
on August 23, 2023, the Government filed a Notice of Service and 
Motion to Dismiss Request for Hearing as Untimely and to Terminate 
Proceedings, which included as an attachment the Declaration of a 
DEA Diversion Investigator asserting that on July 11, 2023, 
Registrant was personally served with the OSC/ISO at his registered 
address. RFAAX 2, at 1, 3, 13.
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    Further, ``[i]n the event that a registrant . . . is deemed to be 
in default . . . DEA may then file a request for final agency action 
with the Administrator, along with a record to support its request. In 
such circumstances, the Administrator may enter a default final order 
pursuant to [21 CFR] Sec.  1316.67.'' Id. Sec.  1301.43(f)(1). Here, 
the Government has requested final agency action based on Respondent's 
default pursuant to 21 CFR 1301.43(c), (f). See also id. Sec.  1316.67.

I. Findings of Fact

    The Agency finds that, in light of Respondent's default, the 
factual allegations in the OSC/ISO are admitted.

Colorado Standard of Care

    Respondent is deemed to have admitted that the applicable standard 
of care for the practice of medicine in Colorado indicates that prior 
to prescribing opioid medication, a physician must, among other things: 
(1) establish a bona fide provider-patient relationship; (2) establish 
a diagnosis and legitimate medical purpose through performing a 
history, physical exam, laboratory imaging, and other studies; (3) 
assess the risk of opioid therapy, including identifying patient and 
family history and medication history through review of Prescription 
Drug Monitoring Program (PDMP) data; (4) assess the patient's pain for 
its nature, intensity, type, frequency, duration, and impact on 
function; (5) assess the patient's functional ability during treatment 
and prior to change in medications; (6) consider referrals to other 
providers for mental health assessments if necessary; and (7) review 
the PDMP patient profile. RFAAX 1, at 2. Further, Respondent admits 
that the applicable standard of care provides that clinicians should 
continue opioid therapy only if there is a clinically meaningful 
improvement in pain and function that outweighs the risk to patient 
safety and should practice particular caution when co-prescribing 
opioid pain medication with benzodiazepines or muscle relaxants and/or 
sedative hypnotics. Id. at 2-3.

Patient N.B.

    According to the OSC/ISO, between June 2021 and October 2022, 
Respondent issued prescriptions for controlled substances to Patient 
N.B. on an approximately monthly basis; these prescriptions included 
prescriptions for fentanyl 50 mg (a schedule II opioid), zolpidem 
tartrate 10 mg (a schedule IV sedative), oxycodone/acetaminophen 10/325 
mg (a schedule II opioid), alprazolam 2 mg (a schedule IV 
benzodiazepine), and tramadol 50 mg (a schedule V opioid). RFAAX 1, at 
3. Respondent has admitted that he issued these prescriptions without 
conducting an appropriate evaluation, without appropriately 
establishing a medical justification, without proper medical records, 
and without conducting proper ongoing monitoring of the patient. Id. 
Respondent has also admitted that he did not issue the above-referenced 
controlled substance prescriptions for a legitimate medical purpose in 
the usual course of professional practice. Id. at 4.

Patient K.C.

    According to the OSC/ISO, between June 2021 and February 2023, 
Respondent issued prescriptions for controlled substances to Patient 
K.C. on an approximately monthly basis; these prescriptions included 
prescriptions for oxycodone 30 mg (a schedule II opioid), carisoprodol 
350 mg (a schedule IV muscle relaxant) and pregabalin 300 mg (a 
schedule V anti-convulsant). Id. at 4. Respondent has admitted that he 
issued these prescriptions without conducting an appropriate 
evaluation, without appropriately establishing a medical justification, 
without proper medical records, and without conducting proper ongoing 
monitoring of the patient. Id. Respondent has also admitted that he did 
not issue the above-referenced controlled substance prescriptions for a 
legitimate medical purpose in the usual course of professional 
practice. Id.

Patient B.M.

    According to the OSC/ISO, between June 2021 and March 2023, 
Respondent issued prescriptions for controlled substances to Patient 
B.M. on an approximately monthly basis; these prescriptions included 
prescriptions for oxycodone 10 mg, alprazolam 2 mg, oxycodone/
acetaminophen 10/325 mg, OxyContin 30 mg (a brand name drug containing 
an extended release formulation of oxycodone), and carisoprodol 350 mg. 
Id. at 5. Respondent has admitted that he issued these prescriptions 
without conducting an appropriate evaluation, without appropriately 
establishing a medical justification, without proper medical records, 
and without conducting proper ongoing monitoring of the patient. Id. 
Respondent has also admitted that he did not issue the above-referenced 
controlled substance prescriptions for a legitimate medical purpose in 
the usual course of professional practice. Id.

Patient R.M.

    According to the OSC/ISO, between June 2021 and February 2023, 
Respondent issued prescriptions for controlled substances to Patient 
R.M. on an approximately monthly basis; these prescriptions included 
prescriptions for oxycodone 10 mg and 20 mg, zolpidem tartrate 10 mg, 
and lorazepam 0.5 mg (a schedule IV benzodiazepine). Id. Respondent has 
admitted that he issued these prescriptions without conducting an 
appropriate evaluation, without appropriately establishing a medical 
justification, without proper medical records, and without conducting 
proper ongoing monitoring of the patient. Id. Respondent has also 
admitted that he did not issue the above-referenced controlled 
substance prescriptions for a legitimate medical purpose in the usual 
course of professional practice. Id. at 6.

Patient S.S.

    According to the OSC/ISO, between June 2021 and February 2023, 
Respondent issued prescriptions for controlled substances to Patient 
S.S. on an approximately monthly basis; these prescriptions included 
prescriptions for oxycodone 10 mg and 20 mg, alprazolam 0.5 mg and 1 
mg, lorazepam 0.5 mg, and OxyContin 60 mg. Id. at 6. Respondent has 
admitted that he issued these prescriptions without conducting an 
appropriate evaluation, without appropriately establishing a medical 
justification, without proper medical records, and without conducting 
proper ongoing monitoring of the patient. Id. Respondent has also 
admitted that he did not issue the above-referenced controlled 
substance prescriptions for a legitimate medical purpose in the usual 
course of professional practice. Id.

Patient P.M.

    According to the OSC/ISO, between June 2021 and March 2023, 
Respondent issued prescriptions for controlled substances to Patient 
P.M. on an approximately monthly basis; these prescriptions included 
prescriptions for oxycodone 30 mg, hydromorphone 4 mg and 8 mg (a 
schedule II opioid), alprazolam 2 mg, and testosterone 200 mg/ml (a 
schedule III steroid). Id. at 6-7. Respondent has admitted that he 
issued these prescriptions without conducting an appropriate 
evaluation, without appropriately establishing a medical justification, 
without proper medical records, and without conducting proper ongoing 
monitoring of the patient. Id. at 7. Respondent has also admitted that 
he did not issue the above-referenced controlled substance 
prescriptions for a legitimate medical

[[Page 13378]]

purpose in the usual course of professional practice. Id.

Patient D.J.

    According to the OSC/ISO, between June 2021 and December 2022, 
Respondent issued prescriptions for controlled substances to Patient 
D.J. on an approximately monthly basis; these prescriptions included 
prescriptions for oxycodone 30 mg and lorazepam 2 mg. Id. Respondent 
has admitted that he issued these prescriptions without conducting an 
appropriate evaluation, without appropriately establishing a medical 
justification, without proper medical records, and without conducting 
proper ongoing monitoring of the patient. Id. Respondent has also 
admitted that he did not issue the above-referenced controlled 
substance prescriptions for a legitimate medical purpose in the usual 
course of professional practice. Id. at 8.

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).
    While the Agency has considered all of the public interest factors 
in 21 U.S.C. 823(g)(1),\2\ 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 RFAAX 1, at 2-8. Moreover, the 
Government has the burden of proof in this proceeding. 21 CFR 1301.44.
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    \2\ As to Factor A, the record contains no evidence of a 
recommendation from any state licensing board or professional 
disciplinary authority. 21 U.S.C. 823(g)(1)(A). Nonetheless, an 
absence of such evidence ``does not weigh for or against a 
determination as to whether continuation of the [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. Dewey C. MacKay, M.D., 75 FR 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. Finally, 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 
would be ``inconsistent with the public interest.'' 21 U.S.C. 
824(a)(4).

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 both federal and state law regulating 
controlled substances. RFAAX 1, at 2-8. Specifically, federal law 
states 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). Further, Colorado state law defines 
``unprofessional conduct'' as ``[a]dministering, dispensing, or 
prescribing any habit-forming drug or any controlled substance . . . 
other than in the course of legitimate professional practice,'' as well 
as ``[a]ny act or omission that fails to meet generally accepted 
standards of medical practice.'' Colo. Rev. Stat. section 12-240-
121(1)(c), (j).
    Here, Respondent has admitted that he repeatedly issued 
prescriptions for controlled substances without conducting appropriate 
evaluations, without appropriately establishing medical justifications, 
without taking and keeping proper medical records, and without 
conducting proper ongoing monitoring of his patients. Respondent 
further admitted that none of the above-referenced controlled substance 
prescriptions were issued for a legitimate medical purpose or in the 
usual course of professional practice. As such, the Agency finds that 
Respondent repeatedly violated 21 CFR 1306.04(a) and Colorado Revised 
Statutes section 12-240-121(1)(c).
    Accordingly, the Agency 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). The Agency further finds 
that Respondent failed to provide any evidence to rebut the 
Government's prima facie case.

III. Sanction

    Where, as here, the Government has established grounds to revoke 
Respondent's registration, the burden shifts to Respondent 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 respondent 
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 
repeatedly failed to answer the allegations contained in the OSC/ISO, 
failed to file any other responses as directed by the Chief ALJ, 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 entrusted

[[Page 13379]]

with registration. Moreover, the evidence presented by the Government 
shows that Respondent violated the CSA, further indicating that 
Respondent 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. 
AP1388948 issued to Henry Manning Pickett, 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 Henry Manning Pickett, M.D., to 
renew or modify this registration, as well as any other pending 
application of Henry Manning Pickett, M.D., for additional registration 
in Colorado. This Order is effective March 25, 2024.

Signing Authority

    This document of the Drug Enforcement Administration was signed on 
February 14, 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. 2024-03548 Filed 2-21-24; 8:45 am]
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