81_FR_6070 81 FR 6047 - Kenneth H. Bull, M.D.; Decision and Order

81 FR 6047 - Kenneth H. Bull, M.D.; Decision and Order

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 81, Issue 23 (February 4, 2016)

Page Range6047-6049
FR Document2016-02129

Federal Register, Volume 81 Issue 23 (Thursday, February 4, 2016)
[Federal Register Volume 81, Number 23 (Thursday, February 4, 2016)]
[Notices]
[Pages 6047-6049]
From the Federal Register Online  [www.thefederalregister.org]
[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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                                                                                Federal Register / Vol. 81, No. 23 / Thursday, February 4, 2016 / Notices                                                       6047

                                                    medicine safely. . . constitutes                        DEPARTMENT OF JUSTICE                                 during a November 2009 administrative
                                                    unprofessional conduct.’’ See also Cal.                                                                       inspection.1 Id.
                                                    Bus. & Prof. Code sec. 2238 (‘‘A                        Drug Enforcement Administration                          The Show Cause Order was served on
                                                    violation of any federal statute or                                                                           Respondent by registered mail sent to
                                                    regulation, or any of the statutes or                   Kenneth H. Bull, M.D.; Decision and                   his registered location; according to the
                                                    regulations of this state regulating                    Order                                                 Government, the return receipt card
                                                    dangerous drugs or controlled                                                                                 showed that the mailing was received
                                                                                                               On August 21, 2015, the Deputy
                                                    substances constitutes unprofessional                                                                         on September 16, 2015. Request for
                                                                                                            Assistant Administrator, Office of
                                                    conduct.’’).                                                                                                  Final Agency Action (RFAA), at 2; GX
                                                                                                            Diversion Control, Drug Enforcement
                                                       I further conclude that the MBC’s                    Administration (DEA), issued an Order                 7. Thereafter, on September 22, 2015,
                                                    findings establish that Registrant                      to Show Cause to Kenneth H. Bull, M.D.                Respondent, through his attorney, filed
                                                    violated the CSA when he issued                         (Respondent), of Albuquerque, New                     a written response to the Show Cause
                                                    fraudulent prescriptions in his wife’s                  Mexico. GX 1, at 1. The Show Cause                    Order. GX 8.
                                                    name for Klonopin (clonazepam), a                       Order proposed the revocation of                         Therein, Respondent expressly
                                                    schedule IV controlled substance, which                 Respondent’s DEA Certificate of                       waived his right to a hearing but
                                                    he then used and abused. See 21 U.S.C.                  Registration AB5662552, and the denial                submitted a written statement for my
                                                    843(a)(3) (‘‘It shall be unlawful for any               of any applications for renewal or                    consideration. GX 8, at 1 (citing 21 CFR
                                                    person knowingly or intentionally. . .                  modification of the registration, as well             1301.43(c)). Thereafter, the Government
                                                    to acquire or obtain possession of a                    as for any other registration, on two                 submitted a Request for Final Agency
                                                    controlled substance by                                 grounds: (1) That he lacks authority to               Action with supporting documents; in
                                                    misrepresentation, fraud, forgery,                      handle controlled substances in New                   its submission, the Government also
                                                    deception or subterfuge.’’); see also id.               Mexico, the State in which he is                      included Respondent’s written
                                                    sec. 844(a) (‘‘It shall be unlawful for any             registered with DEA, and (2) his                      statement.
                                                    person knowingly or intentionally to                    ‘‘registration would be inconsistent with                Based on Respondent’s submission, I
                                                    possess a controlled substance unless                   the public interest.’’ Id. (citing 21 U.S.C.          find that he has waived his right to a
                                                    such substance was obtained directly, or                823(f), 824(a)(3) and (4)).                           hearing on the allegations of the Show
                                                    pursuant to a valid prescription or                                                                           Cause Order. 21 CFR 1301.43(c).
                                                                                                               The Show Cause Order alleged that
                                                    order, from a practitioner, while acting                                                                      However, I will consider Respondent’s
                                                                                                            Respondent is registered as a
                                                    in the course of his professional                                                                             statement along with the evidence
                                                                                                            practitioner in schedules IIN, IIIN, IV
                                                    practice.’’); 21 CFR 1306.04(a) (‘‘A                                                                          submitted by the Government in this
                                                                                                            and V, at the registered address of 3500
                                                    prescription for a controlled                                                                                 matter. I make the following findings of
                                                                                                            Comanche Blvd., Building Suite 6,
                                                    substance. . . must be issued for a                                                                           fact.
                                                                                                            Albuquerque, New Mexico. Id. The
                                                    legitimate medical purpose by an
                                                                                                            Order also alleged that his registration              Findings
                                                    individual practitioner acting in the
                                                                                                            does not expire until July 31, 2017. Id.
                                                    usual course of his professional                                                                                 Respondent, who is a psychiatrist in
                                                    practice.’’). Not only is this conduct                     As grounds for the proposed action,                the State of New Mexico, is the holder
                                                    actionable under Factor Four, it is also                the Show Cause Order alleged that                     of DEA Certificate of Registration
                                                    relevant in assessing Registrant’s                      effective June 30, 2014, the New Mexico               AB5662552, pursuant to which he is
                                                    experience in dispensing controlled                     Medical Board (Board) issued a Decision               currently authorized to dispense
                                                    substances (Factor Two).                                and Order which revoked Respondent’s                  controlled substances in Schedules IIN,
                                                                                                            medical license, thus rendering him                   IIIN, IV and V; his registration does not
                                                       Accordingly, I find that the evidence                without authority ‘‘to order, dispense,
                                                    establishes Registrant ‘‘has committed                                                                        expire until July 31, 2017. GX 2, at 1.
                                                                                                            prescribe or administer any controlled                Respondent was previously authorized
                                                    such acts as would render his                           substances’’ in New Mexico, the State in
                                                    registration. . . inconsistent with the                                                                       to dispense controlled substances in
                                                                                                            which he holds his registration. Id.                  Schedules II through V, as well to
                                                    public interest.’’ See 21 U.S.C. 824(a)(4).             Continuing, the Order asserted that ‘‘the
                                                    Because Registrant failed to respond in                                                                       dispense buprenorphine as a DATA-
                                                                                                            DEA must revoke [Respondent’s]                        Waiver physician. See Bull, 78 FR at
                                                    any manner to the Show Cause Order,                     registration based upon [his] lack of
                                                    I will order that his registration be                                                                         62669. However, on September 22,
                                                                                                            authority to handle controlled                        2013, the then-Administrator issued a
                                                    revoked and that any pending                            substances in’’ New Mexico. Id. (citing
                                                    application be denied.                                                                                        Decision and Order which suspended
                                                                                                            21 U.S.C. 802(21), 823(f), and 824(a)(3)).            Respondent’s registration for six
                                                    Order                                                      As further ground, the Government                  months; the Order also revoked
                                                                                                            alleged that Respondent’s ‘‘registration              Respondent’s DATA-Waiver
                                                       Pursuant to the authority vested in me
                                                                                                            is inconsistent with the public interest              Identification Number and restricted his
                                                    by 21 U.S.C. 823(f) and 824(a), as well
                                                                                                            because [he] did not comply with                      dispensing authority to non-narcotic
                                                    as 28 CFR 0.100(b), I order that DEA
                                                                                                            applicable Federal law related to                     controlled substances only.2 Id. at 62676;
                                                    Certificate of Registration FB4421474,
                                                                                                            controlled substances, in violation of 21             GX 2.
                                                    issued to David W. Bailey, M.D., be, and
                                                                                                            U.S.C. 824(a)(4) and 823(f)(4).’’ Id. The
                                                    it hereby is, revoked. I further order that
                                                                                                            Government based this allegation on the                  1 The Show Cause Order also notified Respondent
                                                    any pending application of David W.
                                                                                                            factual findings and legal conclusions of             of his right to request a hearing on the allegations
asabaliauskas on DSK5VPTVN1PROD with NOTICES




                                                    Bailey, M.D., to renew or modify his
                                                                                                            a prior agency proceeding, which                      or to submit a written statement in lieu of a hearing,
                                                    registration, be, and it hereby is, denied.                                                                   the procedure for electing either option, and the
                                                                                                            suspended his DEA registration for six
                                                    This Order is effective March 7, 2016.                                                                        consequence of failing to elect either option. GX 1,
                                                                                                            months and restricted his registration to             at 2 (citing 21 CFR 1301.43).
                                                      Dated: January 18, 2016.                              non-narcotic controlled substances. Id.                  2 Pursuant to an earlier Board Order, Respondent
                                                    Chuck Rosenberg,                                        at 2 (citing Kenneth Harold Bull, M.D.,               did not, at the time of the prior Agency proceeding,
                                                    Acting Administrator.                                   78 FR 62666 (2013)). The Show Cause                   possess state authority ‘‘to prescribe narcotics,
                                                                                                                                                                  including but not limited to, all opioid analgesics,
                                                    [FR Doc. 2016–02127 Filed 2–3–16; 8:45 am]              Order then set forth several of the 2013              including buprenorphine and all synthetic opioid
                                                    BILLING CODE 4410–09–P                                  Order’s findings of the violations found              analgesics.’’ Id. at 62676.



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                                                    6048                         Federal Register / Vol. 81, No. 23 / Thursday, February 4, 2016 / Notices

                                                       On June 30, 2014, the New Mexico                     called the . . . CPEP. The report was based              Presumably, Respondent served his
                                                    Medical Board issued a Decision and                     on approximately three hours of interview             suspension without incident, and
                                                    Order which adopted nearly all of the                   time with [him] done by unidentified                  notably, the Government makes no
                                                                                                            physician consultants who conducted a
                                                    findings of a state Hearing Officer. GX                 review of a tiny fraction of his total patient
                                                                                                                                                                  allegation in this proceeding that
                                                    4, at 1. The Board suspended                            records (24 records out of hundreds of cases).        Respondent has, since the first
                                                    Respondent’s medical license                            [Respondent] also participated in two 30              proceeding, engaged in any further
                                                    ‘‘effectively immediately,’’ based upon                 minute simulated patient intake interviews            misconduct related to controlled
                                                    ‘‘the deficiencies noted in’’ a report by               with actors playing the patients. The New             substances. See GX 1, at 1–2 (Show
                                                    the Center for Personalized Education                   Mexico Medical Board based its suspension             Cause Order). Indeed, in its Request for
                                                    for Physicians (CPEP), which had                        on its conclusion [that he] required a                Final Agency Action, the Government
                                                    assessed his clinical skills, as well as                residency-type program to continue                    states that Show Cause Order ‘‘did not
                                                                                                            practicing psychiatry, a claim [his] expert
                                                    the Hearing Officer’s ‘‘finding of                      witness disagreed with strongly.4
                                                                                                                                                                  allege that [the Board’s] final order
                                                    manifest incompetence.’’ Id. The Board                  Id.                                                   entails findings that reveal violations
                                                    further ordered that the suspension                                                                           related to [Respondent’s] DEA
                                                                                                               Respondent then argues that ‘‘there is
                                                    would remain in effect until Respondent                                                                       registration.’’ RFAA, at 3. Given the
                                                                                                            no claim [he] engaged in any sort of
                                                    ‘‘successfully completes a Board                                                                              Government’s position that the State
                                                                                                            financial impropriety, diversion of
                                                    approved retraining in a residency or                                                                         Board proceeding does not involve
                                                                                                            medications, boundary issues, or
                                                    residency-like program to address the                                                                         misconduct related to his registration
                                                                                                            harmed a patient in any manner.’’
                                                    deficiencies noted in the CPEP report,’’                                                                      and the absence of evidence of
                                                                                                            Stating that he ‘‘intends to ask the Board
                                                    and that upon completion, he ‘‘may                                                                            misconduct related to controlled
                                                                                                            to modify its order in the near future to
                                                    petition. . . for reinstatement of his                                                                        substances since the first proceeding,
                                                                                                            allow him to resume practice,’’
                                                    medical license.’’Id.                                                                                         there is no basis to invoke the Agency’s
                                                       The Government states that                           Respondent asks that I delay
                                                                                                                                                                  public interest authority to revoke his
                                                    Respondent’s medical license remains                    consideration of the matter ‘‘until this
                                                                                                                                                                  registration.5
                                                    suspended, and Respondent does not                      occurs.’’ Id. Finally, Respondent notes                  There is, however, no dispute that
                                                    deny this in his written statement. GX                  that ‘‘New Mexico is a notoriously                    Respondent lacks authority to handle
                                                    8, at 2. Moreover, a search of the online               underserved medical community’’ and                   controlled substances in New Mexico,
                                                    records of the New Mexico Medical                       that he provided care for patients ‘‘in               the State where he is currently
                                                    Board shows that Respondent’s medical                   desperate need of psychiatric services’’              registered, and pursuant to 21 U.S.C.
                                                    license remains suspended. See http://                  and ‘‘with severe behavioral problems                 824(a)(3), the Attorney General is
                                                    cgi.docboard.org/cgi-shl/nhayer.exe.                    and extremely serious mental illness,’’               authorized to suspend or revoke a
                                                       Respondent’s written statement                       and that ‘‘[h]e will not be able to do so             registration issued under section 823,
                                                    summarizes his academic and                             without a DEA registration.’’ Id. at 3.               ‘‘upon a finding that the registrant . . .
                                                    professional career, noting that he has                 Discussion                                            has had his State license . . .
                                                    been practicing for more than 40                           In its Request for Final Agency                    suspended [or] revoked . . . by
                                                    years.3 Id. at 1–2. Respondent disputes                 Action, the Government asserts two                    competent State authority and is no
                                                    the allegation of the Order to Show                     grounds to revoke Respondent’s                        longer authorized by State law to engage
                                                    Cause that his medical license has been                 registration. RFAA, at 4. With respect to             in the . . . dispensing of controlled
                                                    revoked, arguing that ‘‘the Board                       the public interest ground, the                       substances.’’ Moreover, DEA has
                                                    suspended [his] license pending [his]                   Government contends that, ‘‘in the                    repeatedly held that the possession of
                                                    attending a residency-like program.’’ Id.               present proceeding, [I] can give res                  authority to dispense controlled
                                                    at 2. While Respondent is correct, as a                 judicata effect to the prior DEA final                substances under the laws of the State
                                                    practical matter, this is a distinction                 order,’’ and therefore, ‘‘the prior                   in which a practitioner engages in
                                                    without a material difference.                          findings of fact and conclusions of law               professional practice is a fundamental
                                                       Respondent further states that he                                                                          condition for obtaining and maintaining
                                                                                                            in [that] proceeding may be
                                                    ‘‘strongly disagrees with the Board’s                                                                         a practitioner’s registration.
                                                                                                            incorporated into the present final
                                                    findings and conclusions, but has
                                                                                                            order.’’ Id.
                                                    accepted them.’’ Id. Continuing, he                        The Government does not explain,
                                                                                                                                                                     5 It is noted that the Hearing Officer found that

                                                    states that he ‘‘has freely accepted and                                                                      ‘‘[t]he CPEP Assessment was designed to evaluate
                                                                                                            however, why the factual findings and                 Respondent’s practice of outpatient adolescent and
                                                    described without reservation the                       legal conclusions of the prior Agency                 adult psychiatry, including the prescribing of
                                                    mistakes he had made as a practitioner,                 Decision and Order now support the                    controlled substances within a psychiatry practice,’’
                                                    but disagrees [that] he is ‘manifestly                  revocation of Respondent’s registration               and the CPEP Assessment involved a review of
                                                    incompetent.’’ ’’ ’’Id.                                                                                       Respondent’s medical charts, interviews of
                                                                                                            on public interest grounds. Notably, in               Respondent, and ‘‘simulated patient-physician
                                                       Respondent then engages in a collateral              that proceeding, the prior Administrator              interactions.’’ GX 5, at 8. Moreover, the Board
                                                    attack on the Board’s Order. He argues:                 found that Respondent had accepted                    adopted the Hearing Officer’s findings that
                                                       [T]he Medical Board’s prosecution rested             responsibility and demonstrated that he               Respondent’s ‘‘[c]linical judgment and reasoning
                                                    its case entirely on unsworn hearsay                                                                          were not adequate, particularly his prescribing of
                                                                                                            would not engage in future misconduct                 controlled substances within the context of a
                                                    evidence in the form of a report issued by a            with respect to the misconduct that                   psychiatric practice’’ and ‘‘[h]is documentation in
                                                    Colorado physician assessment organization              ‘‘was properly at issue in the                        the patient charts submitted for review was not
                                                                                                            proceeding.’’ 78 FR at 62675. Moreover,               adequate.’’ Id. The Board also adopted the Hearing
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                                                       3 Respondent states that he is the holder of a DEA                                                         Officer’s finding regarding Respondent’s use of
                                                    Certificate of Registration, which authorizes him to    the prior Administrator did not find the              cheek swabs rather than urine drug screening ‘‘[t]o
                                                    dispense controlled substances in schedules II          misconduct that was proven on the                     address the addiction and diversion issues in his
                                                    through V, including narcotic controlled                record of the proceeding to be                        patients.’’ Id. at 9. However, the Government does
                                                    substances, as a practitioner. GX 8, at 2. Although     sufficiently egregious to warrant                     not argue that these findings support a finding that
                                                    his statement notes that his registration was the                                                             Respondent has committed such acts as would
                                                    subject of a previous DEA show cause proceeding,        revocation. Id. at 62676.                             render his registration inconsistent with the public
                                                    it does not accurately state the outcome of that                                                              interest and, in adjudicating this matter, I rely
                                                    proceeding, which restricted his registration to          4 Respondent also included a copy of the Post-      solely on the Board’s action in suspending his
                                                    authorize the dispensing of only non-narcotic           Hearing Brief filed on his behalf in the Board        medical license and the fact that the suspension
                                                    controlled substances. See 78 FR at 62676.              proceeding.                                           remains in effect.



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                                                                                Federal Register / Vol. 81, No. 23 / Thursday, February 4, 2016 / Notices                                                    6049

                                                       This rule derives from the text of two               citations omitted). ‘‘Rather,                           DEPARTMENT OF JUSTICE
                                                    provisions of the CSA. First, Congress                  Respondent’s challenge to the validity
                                                    defined ‘‘the term ‘practitioner’ [to]                  of the [New Mexico Board’s] Order must                  Notice of Lodging of Proposed Partial
                                                    mean[ ] a . . . physician . . . or other                be litigated in the forums provided by                  Consent Decree Under the Clean Water
                                                    person licensed, registered or otherwise                the State of [New Mexico], and his                      Act
                                                    permitted, by . . . the jurisdiction in                 contentions regarding the validity of the                 On January 28, 2016, the Department
                                                    which he practices . . . to distribute,                 [Board’s] order are not material to this                of Justice lodged a proposed Partial
                                                    dispense, [or] administer . . . a                       Agency’s resolution of whether he is                    Consent Decree with the United States
                                                    controlled substance in the course of                   entitled to maintain his DEA registration               District Court for the Northern District
                                                    professional practice.’’ 21 U.S.C.                      in’’ New Mexico. Id.                                    of Mississippi in the lawsuit entitled
                                                    802(21). Second, in setting the                            Because it is undisputed that
                                                                                                                                                                    United States and the State of
                                                    requirements for obtaining a                            Respondent’s New Mexico medical
                                                    practitioner’s registration, Congress                                                                           Mississippi v. City of Greenville,
                                                                                                            license remains suspended, I find that
                                                    directed that ‘‘[t]he Attorney General                                                                          Mississippi, Civil Action No. 4:16–cv–
                                                                                                            he no longer has authority under the
                                                    shall register practitioners . . . if the                                                                       00018–DMB–JMV.
                                                                                                            laws of New Mexico, the State in which
                                                                                                                                                                      The United States and the State of
                                                    applicant is authorized to dispense . . .               he is registered, to dispense controlled
                                                                                                                                                                    Mississippi filed this lawsuit under the
                                                    controlled substances under the laws of                 substances. Therefore, he is not entitled
                                                                                                                                                                    Clean Water Act and the Mississippi Air
                                                    the State in which he practices.’’ 21                   to maintain his DEA registration. See 21
                                                    U.S.C. 823(f). Because Congress has                                                                             and Water Pollution Control Law. The
                                                                                                            U.S.C. 802(21), 823(f), 824(a)(3).
                                                    clearly mandated that a practitioner                                                                            complaint seeks injunctive relief and
                                                                                                            Accordingly, I will order that his
                                                    possess state authority in order to be                                                                          civil penalties for violations in
                                                                                                            registration be revoked and that any
                                                    deemed a practitioner under the Act,                                                                            connection with the City’s sanitary
                                                                                                            pending application to renew or modify
                                                    DEA has held repeatedly that revocation                                                                         sewer system. The City has grouped
                                                                                                            his registration be denied.6
                                                    of a practitioner’s registration is the                                                                         mini-systems within the sewer system
                                                    appropriate sanction whenever he is no                  Order                                                   into three different groups and
                                                    longer authorized to dispense controlled                   Pursuant to the authority vested in me               prioritized Sewer Group 1 and Sewer
                                                    substances under the laws of the State                  by 21 U.S.C. 823(f) and 824(a), as well                 Group 2 for sewer assessment and
                                                    in which he practices medicine. See,                    as 28 CFR 0.100(b), I order that DEA                    rehabilitation work. The Partial Consent
                                                    e.g., Calvin Ramsey, 76 FR 20034, 20036                 Certificate of Registration AB5662552,                  Decree provides for the City to conduct
                                                    (2011); Sheran Arden Yeates, M.D., 71                   issued to Kenneth Harold Bull, M.D., be,                early action projects; capacity,
                                                    FR 39130, 39131 (2006); Dominick A.                     and it hereby is, revoked. I further order              management, operations, and
                                                    Ricci, 58 FR 51104, 51105 (1993); Bobby                 that any application of Kenneth Harold                  maintenance program; and assessment
                                                    Watts, 53 FR 11919, 11920 (1988).                       Bull, M.D., to renew or modify his                      and rehabilitation of Sewer Groups 1
                                                       Thus, the Agency has held that                       registration, be, and it hereby is, denied.             and 2. The partial settlement will not
                                                    revocation is warranted even where, as                  This Order is effective immediately.7                   resolve the claims for civil penalties or
                                                    here, the state board has suspended (as                                                                         for injunctive relief related to Sewer
                                                                                                              Dated: January 18, 2016.                              Group 3, as those will be the topics of
                                                    opposed to revoked) a practitioner’s
                                                                                                            Chuck Rosenberg,                                        future negotiation among the parties.
                                                    dispensing authority and that authority
                                                    may be restored at some point in the                    Acting Administrator.                                     The publication of this notice opens
                                                    future through further proceedings. See                 [FR Doc. 2016–02129 Filed 2–3–16; 8:45 am]              a period for public comment on the
                                                    Ramsey 76 FR at 20036 (citations                        BILLING CODE 4410–09–P                                  Partial Consent Decree. Comments
                                                    omitted). As the Agency has held, the                                                                           should be addressed to the Assistant
                                                    controlling question is not whether a                      6 While Respondent also asked that I delay the       Attorney General, Environment and
                                                    practitioner’s license to practice                      resolution of this matter, ‘‘in circumstances similar   Natural Resources Division, and should
                                                                                                            to those raised by Respondent, DEA has repeatedly       refer to United States and the State of
                                                    medicine in the state is suspended or                   denied requests to stay the issuance of a final order
                                                    revoked; rather, it is whether the                      of revocation, noting that [u]nder the Controlled       Mississippi v. City of Greenville,
                                                    Respondent is currently authorized to                   Substances Act, a practitioner must be currently        Mississippi, D.J. Ref. No. 90–5–1–1–
                                                    handle controlled substances in the                     authorized to handle controlled substances in the       10932. All comments must be submitted
                                                                                                            jurisdiction in which [he] practices in order to        no later than thirty (30) days after the
                                                    state. James L. Hooper, 76 FR 71371                     maintain [his] DEA registration.’’ Gregory F. Saric,
                                                    (2011) (collecting cases), pet. for rev.                76 FR 16821, 16822 (2011) (internal quotations and      publication date of this notice.
                                                    denied, Hooper v. Holder, 481 Fed.                      citations omitted). Of further note, Respondent’s       Comments may be submitted either by
                                                    Appx. 826 (4th Cir. 2012).                              state medical license was suspended more than 18        email or by mail:
                                                       Respondent further argues that I                     months ago, and yet his license still remains
                                                                                                            suspended.
                                                    should consider that the Medical                                                                                To submit
                                                                                                               Finally, while Respondent asserts that New                               Send them to:
                                                    Board’s case ‘‘rested entirely on                                                                               comments:
                                                                                                            Mexico is a medically underserved area, in the case
                                                    unsworn hearsay evidence in the form                    of individual practitioners, DEA has held that
                                                                                                                                                                    By email .......    pubcomment-ees.enrd@
                                                    of’’ the CPEP Report and that his expert                community impact evidence is irrelevant in the
                                                                                                            public interest determination as it is in a                                   usdoj.gov.
                                                    witness ‘‘disagreed with’’ the Board’s                  proceeding based on a loss of state authority. See      By mail .........   Assistant Attorney General,
                                                    conclusion that he should undergo a                     Linda Sue Cheek, 76 FR 66972, 66972 (2011);                                   U.S. DOJ—ENRD, P.O.
                                                    ‘‘residency-type program to continue                    Gregory Owens, 74 FR 36751, 36757 (2009). So too,                             Box 7611, Washington, DC
                                                    practicing. GX 8, at 2. This argument is                Respondent’s statement regarding his acceptance of
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                                                                                                                                                                                          20044–7611.
                                                                                                            responsibility is not a defense to a revocation based
                                                    simply a collateral attack on the State                 on the loss of state authority, because the CSA
                                                    Board proceeding. The Agency has held,                  mandate that a practitioner possess such authority        During the public comment period,
                                                    however, ‘‘that a registrant cannot                     to obtain and maintain a DEA registration.              the Partial Consent Decree may be
                                                    collaterally attack the result of a state                  7 Based on the findings of fact and conclusions of   examined and downloaded at this
                                                    criminal or administrative proceeding in                law which led the NMMB to immediately suspend           Justice Department Web site: http://
                                                                                                            Registrant’s license until he successfully completes
                                                    a proceeding under section 304, 21                      Board approved re-training,’’ GX 4, at 1; I conclude
                                                                                                                                                                    www.justice.gov/enrd/consent-decrees.
                                                    U.S.C. 824, of the CSA.’’ Muzaffer                      that the public interest requires that this Order be    We will provide a paper copy of the
                                                    Aslan, 77 FR 37068, 37069 (2012) (other                 effective immediately. See 21 CFR 1316.67.              Partial Consent Decree upon written


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Document Created: 2016-02-04 00:31:39
Document Modified: 2016-02-04 00:31:39
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
FR Citation81 FR 6047 

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