[Federal Register Volume 81, Number 23 (Thursday, February 4, 2016)]
[Notices]
[Pages 6047-6049]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-02129]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Kenneth H. Bull, M.D.; Decision and Order

    On August 21, 2015, the Deputy Assistant Administrator, Office of 
Diversion Control, Drug Enforcement Administration (DEA), issued an 
Order to Show Cause to Kenneth H. Bull, M.D. (Respondent), of 
Albuquerque, New Mexico. GX 1, at 1. The Show Cause Order proposed the 
revocation of Respondent's DEA Certificate of Registration AB5662552, 
and the denial of any applications for renewal or modification of the 
registration, as well as for any other registration, on two grounds: 
(1) That he lacks authority to handle controlled substances in New 
Mexico, the State in which he is registered with DEA, and (2) his 
``registration would be inconsistent with the public interest.'' Id. 
(citing 21 U.S.C. 823(f), 824(a)(3) and (4)).
    The Show Cause Order alleged that Respondent is registered as a 
practitioner in schedules IIN, IIIN, IV and V, at the registered 
address of 3500 Comanche Blvd., Building Suite 6, Albuquerque, New 
Mexico. Id. The Order also alleged that his registration does not 
expire until July 31, 2017. Id.
    As grounds for the proposed action, the Show Cause Order alleged 
that effective June 30, 2014, the New Mexico Medical Board (Board) 
issued a Decision and Order which revoked Respondent's medical license, 
thus rendering him without authority ``to order, dispense, prescribe or 
administer any controlled substances'' in New Mexico, the State in 
which he holds his registration. Id. Continuing, the Order asserted 
that ``the DEA must revoke [Respondent's] registration based upon [his] 
lack of authority to handle controlled substances in'' New Mexico. Id. 
(citing 21 U.S.C. 802(21), 823(f), and 824(a)(3)).
    As further ground, the Government alleged that Respondent's 
``registration is inconsistent with the public interest because [he] 
did not comply with applicable Federal law related to controlled 
substances, in violation of 21 U.S.C. 824(a)(4) and 823(f)(4).'' Id. 
The Government based this allegation on the factual findings and legal 
conclusions of a prior agency proceeding, which suspended his DEA 
registration for six months and restricted his registration to non-
narcotic controlled substances. Id. at 2 (citing Kenneth Harold Bull, 
M.D., 78 FR 62666 (2013)). The Show Cause Order then set forth several 
of the 2013 Order's findings of the violations found during a November 
2009 administrative inspection.\1\ Id.
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    \1\ The Show Cause Order also notified Respondent of his right 
to request a hearing on the allegations or to submit a written 
statement in lieu of a hearing, the procedure for electing either 
option, and the consequence of failing to elect either option. GX 1, 
at 2 (citing 21 CFR 1301.43).
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    The Show Cause Order was served on Respondent by registered mail 
sent to his registered location; according to the Government, the 
return receipt card showed that the mailing was received on September 
16, 2015. Request for Final Agency Action (RFAA), at 2; GX 7. 
Thereafter, on September 22, 2015, Respondent, through his attorney, 
filed a written response to the Show Cause Order. GX 8.
    Therein, Respondent expressly waived his right to a hearing but 
submitted a written statement for my consideration. GX 8, at 1 (citing 
21 CFR 1301.43(c)). Thereafter, the Government submitted a Request for 
Final Agency Action with supporting documents; in its submission, the 
Government also included Respondent's written statement.
    Based on Respondent's submission, I find that he has waived his 
right to a hearing on the allegations of the Show Cause Order. 21 CFR 
1301.43(c). However, I will consider Respondent's statement along with 
the evidence submitted by the Government in this matter. I make the 
following findings of fact.

Findings

    Respondent, who is a psychiatrist in the State of New Mexico, is 
the holder of DEA Certificate of Registration AB5662552, pursuant to 
which he is currently authorized to dispense controlled substances in 
Schedules IIN, IIIN, IV and V; his registration does not expire until 
July 31, 2017. GX 2, at 1. Respondent was previously authorized to 
dispense controlled substances in Schedules II through V, as well to 
dispense buprenorphine as a DATA-Waiver physician. See Bull, 78 FR at 
62669. However, on September 22, 2013, the then-Administrator issued a 
Decision and Order which suspended Respondent's registration for six 
months; the Order also revoked Respondent's DATA-Waiver Identification 
Number and restricted his dispensing authority to non-narcotic 
controlled substances only.\2\ Id. at 62676; GX 2.
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    \2\ Pursuant to an earlier Board Order, Respondent did not, at 
the time of the prior Agency proceeding, possess state authority 
``to prescribe narcotics, including but not limited to, all opioid 
analgesics, including buprenorphine and all synthetic opioid 
analgesics.'' Id. at 62676.

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[[Page 6048]]

    On June 30, 2014, the New Mexico Medical Board issued a Decision 
and Order which adopted nearly all of the findings of a state Hearing 
Officer. GX 4, at 1. The Board suspended Respondent's medical license 
``effectively immediately,'' based upon ``the deficiencies noted in'' a 
report by the Center for Personalized Education for Physicians (CPEP), 
which had assessed his clinical skills, as well as the Hearing 
Officer's ``finding of manifest incompetence.'' Id. The Board further 
ordered that the suspension would remain in effect until Respondent 
``successfully completes a Board approved retraining in a residency or 
residency-like program to address the deficiencies noted in the CPEP 
report,'' and that upon completion, he ``may petition. . . for 
reinstatement of his medical license.''Id.
    The Government states that Respondent's medical license remains 
suspended, and Respondent does not deny this in his written statement. 
GX 8, at 2. Moreover, a search of the online records of the New Mexico 
Medical Board shows that Respondent's medical license remains 
suspended. See http://cgi.docboard.org/cgi-shl/nhayer.exe.
    Respondent's written statement summarizes his academic and 
professional career, noting that he has been practicing for more than 
40 years.\3\ Id. at 1-2. Respondent disputes the allegation of the 
Order to Show Cause that his medical license has been revoked, arguing 
that ``the Board suspended [his] license pending [his] attending a 
residency-like program.'' Id. at 2. While Respondent is correct, as a 
practical matter, this is a distinction without a material difference.
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    \3\ Respondent states that he is the holder of a DEA Certificate 
of Registration, which authorizes him to dispense controlled 
substances in schedules II through V, including narcotic controlled 
substances, as a practitioner. GX 8, at 2. Although his statement 
notes that his registration was the subject of a previous DEA show 
cause proceeding, it does not accurately state the outcome of that 
proceeding, which restricted his registration to authorize the 
dispensing of only non-narcotic controlled substances. See 78 FR at 
62676.
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    Respondent further states that he ``strongly disagrees with the 
Board's findings and conclusions, but has accepted them.'' Id. 
Continuing, he states that he ``has freely accepted and described 
without reservation the mistakes he had made as a practitioner, but 
disagrees [that] he is `manifestly incompetent.'' '' ''Id.

    Respondent then engages in a collateral attack on the Board's 
Order. He argues:

    [T]he Medical Board's prosecution rested its case entirely on 
unsworn hearsay evidence in the form of a report issued by a 
Colorado physician assessment organization called the . . . CPEP. 
The report was based on approximately three hours of interview time 
with [him] done by unidentified physician consultants who conducted 
a review of a tiny fraction of his total patient records (24 records 
out of hundreds of cases). [Respondent] also participated in two 30 
minute simulated patient intake interviews with actors playing the 
patients. The New Mexico Medical Board based its suspension on its 
conclusion [that he] required a residency-type program to continue 
practicing psychiatry, a claim [his] expert witness disagreed with 
strongly.\4\
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    \4\ Respondent also included a copy of the Post-Hearing Brief 
filed on his behalf in the Board proceeding.
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Id.

    Respondent then argues that ``there is no claim [he] engaged in any 
sort of financial impropriety, diversion of medications, boundary 
issues, or harmed a patient in any manner.'' Stating that he ``intends 
to ask the Board to modify its order in the near future to allow him to 
resume practice,'' Respondent asks that I delay consideration of the 
matter ``until this occurs.'' Id. Finally, Respondent notes that ``New 
Mexico is a notoriously underserved medical community'' and that he 
provided care for patients ``in desperate need of psychiatric 
services'' and ``with severe behavioral problems and extremely serious 
mental illness,'' and that ``[h]e will not be able to do so without a 
DEA registration.'' Id. at 3.

Discussion

    In its Request for Final Agency Action, the Government asserts two 
grounds to revoke Respondent's registration. RFAA, at 4. With respect 
to the public interest ground, the Government contends that, ``in the 
present proceeding, [I] can give res judicata effect to the prior DEA 
final order,'' and therefore, ``the prior findings of fact and 
conclusions of law in [that] proceeding may be incorporated into the 
present final order.'' Id.
    The Government does not explain, however, why the factual findings 
and legal conclusions of the prior Agency Decision and Order now 
support the revocation of Respondent's registration on public interest 
grounds. Notably, in that proceeding, the prior Administrator found 
that Respondent had accepted responsibility and demonstrated that he 
would not engage in future misconduct with respect to the misconduct 
that ``was properly at issue in the proceeding.'' 78 FR at 62675. 
Moreover, the prior Administrator did not find the misconduct that was 
proven on the record of the proceeding to be sufficiently egregious to 
warrant revocation. Id. at 62676.
    Presumably, Respondent served his suspension without incident, and 
notably, the Government makes no allegation in this proceeding that 
Respondent has, since the first proceeding, engaged in any further 
misconduct related to controlled substances. See GX 1, at 1-2 (Show 
Cause Order). Indeed, in its Request for Final Agency Action, the 
Government states that Show Cause Order ``did not allege that [the 
Board's] final order entails findings that reveal violations related to 
[Respondent's] DEA registration.'' RFAA, at 3. Given the Government's 
position that the State Board proceeding does not involve misconduct 
related to his registration and the absence of evidence of misconduct 
related to controlled substances since the first proceeding, there is 
no basis to invoke the Agency's public interest authority to revoke his 
registration.\5\
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    \5\ It is noted that the Hearing Officer found that ``[t]he CPEP 
Assessment was designed to evaluate Respondent's practice of 
outpatient adolescent and adult psychiatry, including the 
prescribing of controlled substances within a psychiatry practice,'' 
and the CPEP Assessment involved a review of Respondent's medical 
charts, interviews of Respondent, and ``simulated patient-physician 
interactions.'' GX 5, at 8. Moreover, the Board adopted the Hearing 
Officer's findings that Respondent's ``[c]linical judgment and 
reasoning were not adequate, particularly his prescribing of 
controlled substances within the context of a psychiatric practice'' 
and ``[h]is documentation in the patient charts submitted for review 
was not adequate.'' Id. The Board also adopted the Hearing Officer's 
finding regarding Respondent's use of cheek swabs rather than urine 
drug screening ``[t]o address the addiction and diversion issues in 
his patients.'' Id. at 9. However, the Government does not argue 
that these findings support a finding that Respondent has committed 
such acts as would render his registration inconsistent with the 
public interest and, in adjudicating this matter, I rely solely on 
the Board's action in suspending his medical license and the fact 
that the suspension remains in effect.
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    There is, however, no dispute that Respondent lacks authority to 
handle controlled substances in New Mexico, the State where he is 
currently registered, and pursuant to 21 U.S.C. 824(a)(3), the Attorney 
General is authorized to suspend or revoke a registration issued under 
section 823, ``upon a finding that the registrant . . . has had his 
State license . . . suspended [or] revoked . . . by competent State 
authority and is no longer authorized by State law to engage in the . . 
. dispensing of controlled substances.'' Moreover, DEA has repeatedly 
held that the possession of authority to dispense controlled substances 
under the laws of the State in which a practitioner engages in 
professional practice is a fundamental condition for obtaining and 
maintaining a practitioner's registration.

[[Page 6049]]

    This rule derives from the text of two provisions of the CSA. 
First, Congress defined ``the term `practitioner' [to] mean[ ] a . . . 
physician . . . or other person licensed, registered or otherwise 
permitted, by . . . the jurisdiction in which he practices . . . to 
distribute, dispense, [or] administer . . . a controlled substance in 
the course of professional practice.'' 21 U.S.C. 802(21). Second, in 
setting the requirements for obtaining a practitioner's registration, 
Congress directed that ``[t]he Attorney General shall register 
practitioners . . . if the applicant is authorized to dispense . . . 
controlled substances under the laws of the State in which he 
practices.'' 21 U.S.C. 823(f). Because Congress has clearly mandated 
that a practitioner possess state authority in order to be deemed a 
practitioner under the Act, DEA has held repeatedly that revocation of 
a practitioner's registration is the appropriate sanction whenever he 
is no longer authorized to dispense controlled substances under the 
laws of the State in which he practices medicine. See, e.g., Calvin 
Ramsey, 76 FR 20034, 20036 (2011); Sheran Arden Yeates, M.D., 71 FR 
39130, 39131 (2006); Dominick A. Ricci, 58 FR 51104, 51105 (1993); 
Bobby Watts, 53 FR 11919, 11920 (1988).
    Thus, the Agency has held that revocation is warranted even where, 
as here, the state board has suspended (as opposed to revoked) a 
practitioner's dispensing authority and that authority may be restored 
at some point in the future through further proceedings. See Ramsey 76 
FR at 20036 (citations omitted). As the Agency has held, the 
controlling question is not whether a practitioner's license to 
practice medicine in the state is suspended or revoked; rather, it is 
whether the Respondent is currently authorized to handle controlled 
substances in the state. James L. Hooper, 76 FR 71371 (2011) 
(collecting cases), pet. for rev. denied, Hooper v. Holder, 481 Fed. 
Appx. 826 (4th Cir. 2012).
    Respondent further argues that I should consider that the Medical 
Board's case ``rested entirely on unsworn hearsay evidence in the form 
of'' the CPEP Report and that his expert witness ``disagreed with'' the 
Board's conclusion that he should undergo a ``residency-type program to 
continue practicing. GX 8, at 2. This argument is simply a collateral 
attack on the State Board proceeding. The Agency has held, however, 
``that a registrant cannot collaterally attack the result of a state 
criminal or administrative proceeding in a proceeding under section 
304, 21 U.S.C. 824, of the CSA.'' Muzaffer Aslan, 77 FR 37068, 37069 
(2012) (other citations omitted). ``Rather, Respondent's challenge to 
the validity of the [New Mexico Board's] Order must be litigated in the 
forums provided by the State of [New Mexico], and his contentions 
regarding the validity of the [Board's] order are not material to this 
Agency's resolution of whether he is entitled to maintain his DEA 
registration in'' New Mexico. Id.
    Because it is undisputed that Respondent's New Mexico medical 
license remains suspended, I find that he no longer has authority under 
the laws of New Mexico, the State in which he is registered, to 
dispense controlled substances. Therefore, he is not entitled to 
maintain his DEA registration. See 21 U.S.C. 802(21), 823(f), 
824(a)(3). Accordingly, I will order that his registration be revoked 
and that any pending application to renew or modify his registration be 
denied.\6\
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    \6\ While Respondent also asked that I delay the resolution of 
this matter, ``in circumstances similar to those raised by 
Respondent, DEA has repeatedly denied requests to stay the issuance 
of a final order of revocation, noting that [u]nder the Controlled 
Substances Act, a practitioner must be currently authorized to 
handle controlled substances in the jurisdiction in which [he] 
practices in order to maintain [his] DEA registration.'' Gregory F. 
Saric, 76 FR 16821, 16822 (2011) (internal quotations and citations 
omitted). Of further note, Respondent's state medical license was 
suspended more than 18 months ago, and yet his license still remains 
suspended.
    Finally, while Respondent asserts that New Mexico is a medically 
underserved area, in the case of individual practitioners, DEA has 
held that community impact evidence is irrelevant in the public 
interest determination as it is in a proceeding based on a loss of 
state authority. See Linda Sue Cheek, 76 FR 66972, 66972 (2011); 
Gregory Owens, 74 FR 36751, 36757 (2009). So too, Respondent's 
statement regarding his acceptance of responsibility is not a 
defense to a revocation based on the loss of state authority, 
because the CSA mandate that a practitioner possess such authority 
to obtain and maintain a DEA registration.
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Order

    Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 
824(a), as well as 28 CFR 0.100(b), I order that DEA Certificate of 
Registration AB5662552, issued to Kenneth Harold Bull, M.D., be, and it 
hereby is, revoked. I further order that any application of Kenneth 
Harold Bull, M.D., to renew or modify his registration, be, and it 
hereby is, denied. This Order is effective immediately.\7\
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    \7\ Based on the findings of fact and conclusions of law which 
led the NMMB to immediately suspend Registrant's license until he 
successfully completes Board approved re-training,'' GX 4, at 1; I 
conclude that the public interest requires that this Order be 
effective immediately. See 21 CFR 1316.67.

    Dated: January 18, 2016.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2016-02129 Filed 2-3-16; 8:45 am]
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