83_FR_61909 83 FR 61678 - Narciso A. Reyes, M.D.; Decision and Order

83 FR 61678 - Narciso A. Reyes, M.D.; Decision and Order

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 83, Issue 231 (November 30, 2018)

Page Range61678-61681
FR Document2018-26047

Federal Register, Volume 83 Issue 231 (Friday, November 30, 2018)
[Federal Register Volume 83, Number 231 (Friday, November 30, 2018)]
[Notices]
[Pages 61678-61681]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-26047]


-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 18-32]


Narciso A. Reyes, M.D.; Decision and Order

    On April 19, 2018, the Assistant Administrator, Diversion Control 
Division, Drug Enforcement Administration (hereinafter, DEA or 
Government), issued an Order to Show Cause to Narciso A. Reyes, M.D. 
(hereinafter, Respondent), of Luquillo, Puerto Rico. Order to Show 
Cause (hereinafter, OSC), at 1. The Show Cause Order proposes the 
revocation of Respondent's DEA Certificate of Registration on the 
grounds that he materially falsified applications he submitted to DEA 
and that he has been excluded from participation in a program pursuant 
to 42 U.S.C. 1320a-7(a). Id. (citing 21 U.S.C. 824(a)(1) and (5)). It 
also proposes the denial of ``any applications for renewal or 
modification of such registration and any applications for any other 
DEA registration.'' OSC, at 1 (citing 21 U.S.C. 824(a)(1) and (5)).
    Regarding jurisdiction, the Show Cause Order alleges that 
Respondent holds DEA Certificate of Registration No. FR4900305 at the 
registered address of Calle Fernandez Garcia 306, Luquillo, Puerto Rico 
00773, with a mailing address of P.O. Box 247, Luquillo, PR 00773. OSC, 
at 2. This registration, the OSC alleges, authorizes Respondent to 
dispense controlled substances in schedules II through V as a 
practitioner. Id. The Show Cause Order alleges that this registration 
expires on April 30, 2020. Id.
    Regarding the substantive grounds for the proceeding, the Show 
Cause Order alleges that, on October 20, 2009, the U.S. Department of 
Health and Human Services, Office of Inspector General (hereinafter, 
HHS/OIG), mandatorily excluded Respondent from participating in all 
Federal health care programs due to his conviction in U.S. District 
Court for conspiracy to commit health care fraud. Id. at 2 (citing 42 
U.S.C. 1320a-7(a)(1)). According to the OSC, Respondent's ``mandatory 
exclusion from Medicare, Medicaid and all Federal health care programs 
warrants revocation of . . . [his] registration.'' OSC, at 2 (citing 21 
U.S.C. 824(a)(5)).
    The Show Cause Order further alleges that Respondent provided false 
answers to two ``yes'' or ``no'' liability questions when he applied 
for a DEA registration on October 16, 2014 and when he filed a renewal 
application on April 17, 2017. OSC, at 2-3. Specifically, the Show

[[Page 61679]]

Cause Order alleges that Respondent twice answered that he had never 
been excluded from participation in a Medicare or state health care 
program when, in fact, he had been. Id. at 2-3. The Show Cause Order 
also alleges that Respondent twice answered that he had never 
surrendered (for cause) a Federal controlled substance registration 
when, in fact, he had. Id. at 3. According to the OSC, Respondent's 
answers to these liability questions are ``material falsifications'' 
that warrant revocation of his registration. Id.
    The Show Cause Order notifies Respondent of his right to request a 
hearing on the allegations or to submit a written statement while 
waiving his right to a hearing, the procedures for electing each 
option, and the consequences for failing to elect either option. Id. at 
3-4 (citing 21 CFR 1301.43). The Show Cause Order also notifies 
Respondent of the opportunity to submit a corrective action plan. OSC, 
at 4-5 (citing 21 U.S.C. 824(c)(2)(C)).
    Respondent timely requested a hearing on May 21, 2018.\1\ Hearing 
Request, at 1. In his Hearing Request, Respondent states that, ``It was 
not my intention to fail to declare a material fact in the request for 
renewal . . . . I do not master the English language well and this may 
have contributed to these errors.'' Id. He also states in his Hearing 
Request that, ``My inclusion of the word N in the renewal request was 
in my estimate to indicate that it did not apply since I had reached an 
agreement with the US Attorney's Office in Puerto Rico. Clearly my 
mistake.'' Id.
---------------------------------------------------------------------------

    \1\ Attached to the Government's Notice of Service of Order to 
Show Cause is a DEA-12 (Receipt for Cash or Other Items) that, 
according to the Government's allegations, Respondent executed when 
the Government served the OSC on April 23, 2018. Respondent did 
challenge the Government's service-related allegations. Thus, I find 
that Respondent's Hearing Request was timely since it was filed 
within 30 days of service of the OSC. 21 CFR 1301.43(a).
---------------------------------------------------------------------------

    The Office of Administrative Law Judges (hereinafter, OALJ) put the 
matter on the docket and assigned it to Administrative Law Judge 
Charles Wm. Dorman (hereinafter, ALJ). I adopt the following statement 
of procedural history from the ALJ's Order Granting the Government's 
Motion for Summary Disposition and Recommended Rulings, Findings of 
Fact, Conclusions of Law, and Decision dated June 22, 2018 
(hereinafter, R.D.).

    On May 31, 2018, the Government filed a Motion for Summary 
Disposition (``Government's Motion''). The Government's Motion 
argued that there is no issue of material fact in this case to 
warrant an adversarial hearing. The Government's Motion further 
requested that I summarily dispose of this matter without a hearing 
and recommend to the Acting Administrator that . . . [Respondent's] 
DEA registration be revoked. On the same day, I issued an Order 
affording . . . [Respondent] the opportunity to respond to the 
Government's Motion by June 14, 2018. I explained that if . . . 
[Respondent] disagreed with any of the Government's statements of 
undisputed material facts as outlined in its motion for summary 
disposition, he should provide copies of documentary evidence 
refuting the Government's statement(s). I further directed . . . 
[Respondent] to identify the material fact(s) which justify an 
evidentiary hearing in this case. . . . [Respondent] failed to 
respond to the Government's Motion by the deadline on June 14, 2018.
    On June 15, 2018, the day after . . . [Respondent's] Response 
was due, chambers staff emailed . . . [Respondent's] counsel 
notifying him that the OALJ had not received a response from him and 
asking whether he intended to submit a late filing. . . . 
[Respondent's] counsel replied by email on June 17, 2018, with the 
following statement: ``There are no allegations on behalf of . . . 
[Respondent]. The documents are self [e]xplanatory.''
    Then, on June 21, 2018, the OALJ received a filing from . . . 
[Respondent's] counsel titled ``Statement of Narciso A. Reyes, 
M.D.'' The filing states that . . . [Respondent] ``will not make any 
statement regarding this administrative action'' and that ``[t]he 
issue is hereby submitted for final ruling.''

R.D., at 2-3, 7.
    The ALJ correctly concluded that Respondent's choice not to refute, 
challenge, or even address any of the Government's reliable and 
probative evidence and legal arguments ``strongly indicates that he no 
longer wishes to proceed to hearing.'' Id. at 10. After analyzing the 
Government's evidence and legal argument, the ALJ granted the 
Government's Motion for Summary Disposition and recommended that I 
revoke Respondent's registration and deny any pending applications for 
renewal or modification. Id. at 10, 18.
    By letter dated July 16, 2018, the ALJ certified and transmitted 
the record to me for final Agency action. In that letter, the ALJ 
advised that neither party filed exceptions and that the time period to 
do so had expired.
    I issue this Decision and Order based on the entire record before 
me. 21 CFR 1301.43(e). I make the following findings of fact.

Findings of Fact

Respondent's Criminal Conviction and Ensuing Mandatory Exclusion

    On November 3, 2008, Respondent pled guilty in Federal District 
Court to one count of conspiracy to commit health care fraud. 
Government's Motion, GE-2 (Plea Agreement, United States v. Reyes 
Carrillo, No. 08-cr-168 (D. P.R. Nov. 3, 2008)), at 1. According to the 
facts submitted by the Assistant United States Attorney and explicitly 
adopted by Respondent, Respondent signed blank or previously completed 
false Certificates of Medical Necessity for durable medical equipment 
for Medicare beneficiaries whom he had never seen. Id. at 9. The 
Federal District Judge entered judgment against Respondent on March 13, 
2009. Government's Motion, GE-3 (Judgment, United States v. Reyes 
Carrillo, No. 08-cr-168-03 (D. P.R. March 13, 2009)), at 1.
    Based on Respondent's conviction for conspiracy to commit health 
care fraud, the HHS/OIG notified Respondent of his mandatory exclusion 
from participation in any capacity in Medicare, Medicaid, and all 
Federal health care programs for the minimum statutory period of five 
years effective October 20, 2009. Government's Motion, GE-4 (HHS/OIG 
Exclusion Letter), at 1 (citing 42 U.S.C. 1320a-7(a)); Government's 
Motion, GE-5 (HHS/OIG Exclusions Search Results: Verify), at 1. The 
HHS/OIG Exclusion Letter advised Respondent that reinstatement of 
eligibility to participate in these programs is not automatic. 
Government's Motion, GE-4, at 2. Respondent is still excluded from 
participation in these programs. Government's Motion, GE-5, at 1.

Respondent's DEA Registration History and Current Registration Status

    On January 31, 2013, Respondent voluntarily surrendered for cause 
DEA registration No. BR3465944. Government's Motion, GE-8 (Respondent's 
DEA-104 Voluntary Surrender of Controlled Substances Privileges), at 1; 
Government's Motion, GE-9 (Certification of Registration History), at 
1. Neither the DEA-104 nor any other evidence in the record explains 
the context of this voluntary surrender. DEA retired registration No. 
BR3465944 on February 4, 2013. Government's Motion, GE-9, at 1.
    On October 16, 2014, Respondent submitted an application for a new 
DEA registration. Government's Motion, GE-10 (Respondent's DEA Form 224 
submitted on October 16, 2014), at 1. The application Respondent 
completed includes ``yes'' or ``no'' liability questions that an 
applicant must answer to advance to the next page of the online DEA 
application. Government's Motion, GE-l (Certification of Registration 
Status), at 2; Government's Motion, GE-10, at 1.
    The first liability question that Respondent answered on his online 
DEA application for a registration asks: ``Has the applicant ever been 
convicted

[[Page 61680]]

of a crime in connection with controlled substance(s) under state or 
federal law, or been excluded or directed to be excluded from 
participation in a medicare or state health care program, or [is] any 
such action pending?'' Government's Motion, GE-1, at 2; Government's 
Motion, GE-10, at 1. Respondent answered ``no'' to this question. 
Government's Motion, GE-1, at 2; Government's Motion, GE-10, at 1. The 
HHS/OIG Exclusion letter makes it clear that Respondent knew or should 
have known that his ``no'' response to this question was false. 
Government's Motion, GE-4, at 1-2.
    The second liability question that Respondent answered on his 
online DEA application for a registration asks: ``Has the applicant 
ever surrendered (for cause) or had a federal controlled substance 
registration revoked, suspended, restricted or denied, or is any such 
action pending?'' Government's Motion, GE-l, at 2; Government's Motion, 
GE-10, at 1. Respondent answered ``no'' to this question. Government's 
Motion, GE-1, at 2; Government's Motion, GE-10, at 1. The DEA-104 
Voluntary Surrender of Controlled Substances Privileges form that 
Respondent signed, however, makes it clear that Respondent knew or 
should have known that his ``no'' response to this question was false. 
Government's Motion, GE-8, at 1.
    DEA approved Respondent's application and, on October 17, 2014, 
assigned DEA Certificate of Registration No. FR4900305 to him. 
Government's Motion, GE-1, at 1.
    On April 17, 2017, Respondent submitted an online DEA renewal 
application for his DEA registration No. FR4900305. Government's 
Motion, GE-1, at 1; Government's Motion, GE-11 (Respondent's DEA Form 
224A submitted on April 17, 2017), at 1. The online DEA renewal 
application Respondent submitted includes ``yes'' or ``no'' liability 
questions that an applicant must answer to advance to the next page of 
the online DEA renewal application. Government's Motion, GE-l, at 1; 
Government's Motion, GE-11, at 1.
    The first liability question that Respondent answered on his online 
DEA renewal application asks: ``Has the applicant ever been convicted 
of a crime in connection with controlled substance(s) under state or 
federal law, or been excluded or directed to be excluded from 
participation in a medicare or state health care program, or [is] any 
such action pending?'' Government's Motion, GE-1, at 1; Government's 
Motion, GE-11, at 1. Respondent answered ``no'' to this question. 
Government's Motion, GE-1, at 1; Government's Motion, GE-11, at 1. 
Again, the HHS/OIG Exclusion letter makes it clear that Respondent knew 
or should have known that his ``no'' response to this question was 
false. Government's Motion, GE-4, at 1-2.
    The second liability question that Respondent answered on his 
online DEA renewal application asks: ``Has the applicant ever 
surrendered (for cause) or had a federal controlled substance 
registration revoked, suspended, restricted or denied, or is any such 
action pending?'' Government's Motion, GE-l, at 1; Government's Motion, 
GE-11, at 1. Respondent answered ``no'' to this question. Government's 
Motion, GE-1, at 1; Government's Motion, GE-11, at 1. Again, the DEA-
104 Voluntary Surrender of Controlled Substances Privileges form that 
Respondent signed makes it clear that Respondent knew or should have 
known that his ``no'' response to this question was false. Government's 
Motion, GE-8, at 1.
    DEA approved Respondent's renewal application on April 19, 2017. 
Government's Motion, GE-1, at 1.
    In sum, Respondent is currently registered as a practitioner in 
schedules II through V under DEA Certificate of Registration FR4900305 
at Calle Fernandez Garcia 306, Luquillo, Puerto Rico 00773. 
Government's Motion, GE-1, at 1. Respondent's registration expires on 
April 30, 2020. Id.

Discussion

The Material Falsification Allegation

    Pursuant to 21 U.S.C. 824(a)(1), the Attorney General may suspend 
or revoke a registration issued under section 823 of Title 21, ``upon a 
finding that the registrant . . . has materially falsified any 
application filed pursuant to or required by this subchapter.'' 
According to Agency precedent, the Government must show that a 
respondent ``knew or should have known'' that his response to a 
liability question was false. Samuel S. Jackson, D.D.S., 72 FR 23,848, 
23,852 (2007). Also according to Agency precedent, a respondent's claim 
that he misunderstood a liability question is not a defense. Alvin 
Darby, M.D., 75 FR 26,993, 26,999 (2010).
    According to the Supreme Court, Federal courts' ``most common 
formulation'' of the concept of ``materiality'' is that ``a concealment 
or misrepresentation is material if it `has a natural tendency to 
influence, or was capable of influencing, the decision of' the 
decisionmaking body to which it was addressed.'' Kungys v. United 
States, 485 U.S. 759, 770 (1988) (quoting Weinstock v. United States, 
231 F.2d 699, 701-02 (D.C. Cir. 1956) (other citation omitted)). The 
Court explicitly addressed what has ``never been the test of 
materiality[--] that the misrepresentation or concealment would more 
likely than not have produced an erroneous decision, or even that it 
would more likely than not have triggered an investigation.'' Kungys, 
supra, 485 U.S. at 771 (emphasis in original). Instead, the Court 
articulated the specific test as ``whether the misrepresentation or 
concealment was predictably capable of affecting, i.e., had a natural 
tendency to affect, the official decision.'' Id.
    As already discussed, when Respondent submitted an online DEA 
application for a registration and an online DEA renewal application, 
he answered ``no'' to whether he had ever been excluded from 
participation in Medicare and to whether he had ever surrendered a 
registration for cause. As I already found above, Respondent's four 
answers were false and he ``knew or should have known'' that they were 
false.
    I next determine the ``materiality'' of Respondent's four answers. 
21 U.S.C. 824(a)(1). Concerning Respondent's false statements about his 
voluntary surrender of DEA registration No. BR3465944, the DEA-104 that 
Respondent executed does not indicate the underlying reason(s) for 
Respondent's ``alleged failure to comply with the Federal requirements 
pertaining to controlled substances.'' Government's Motion, GE-8, at 1. 
Further, as the ALJ noted, the DEA-104 reveals nothing about whether 
Respondent's ``alleged failure'' ``had a natural tendency to affect'' 
an Agency decision. R.D., at 13-14 (quoting Michel P. Toret, M.D., 82 
FR 60,041, 60,043 (2017) quoting Kungys, supra, 485 U.S. at 771). I 
found no evidence in the record concerning the materiality of 
Respondent's two false answers about his voluntary surrender. Thus, I 
agree with the ALJ that the record does not support a finding that 
Respondent's two false answers about his voluntary surrender of 
registration No. BR3465944 were ``materially'' false. 21 U.S.C. 
824(a)(1).
    Concerning Respondent's false statements regarding his mandatory 
exclusion, the Agency has never before considered the materiality of a 
respondent's false answers about his mandatory exclusion as that 
question is posed in this case. I find the ALJ's analysis persuasive: 
``Considering that exclusion from a federal health care program under 
42 U.S.C. 1320a-7(a) is an independent basis for revoking [a]

[[Page 61681]]

registration . . ., it is reasonable to conclude that information 
regarding an applicant's mandatory exclusion by HHS would be `capable 
of influencing the [DEA's] decision.' '' R.D., at 13 (citations 
omitted). I agree with the ALJ. I find that Respondent's failure to 
disclose his mandatory exclusion from a Federal health care program is 
material. Id. Thus, I find that there is substantial evidence in the 
record that Respondent materially falsified a DEA registration 
application and a DEA registration renewal application concerning his 
mandatory exclusion. 21 U.S.C. 824(a)(1).

The Allegation of Mandatory Exclusion From a Federal Health Care 
Program

    Pursuant to 21 U.S.C. 824(a)(5), the Attorney General may suspend 
or revoke a registration issued under section 823 of Title 21, ``upon a 
finding that the registrant . . . has been excluded . . . from 
participation in a program pursuant to section 1320a-7(a) of Title 
42.'' Agency precedent makes clear that revocation under 21 U.S.C. 
824(a)(5) may be appropriate regardless of whether or not the 
misconduct that led to the mandatory exclusion involved controlled 
substances. KK Pharmacy, 64 FR 49,507, 49,510 (1999) (collecting cases) 
(The Agency ``has previously held that misconduct which does not 
involve controlled substances may constitute grounds, under 21 U.S.C. 
824(a)(5), for the revocation of a DEA Certificate of Registration.''); 
Melvin N. Seglin, M.D., 63 FR 70,431, 70,433 (1998) (``[M]isconduct 
which does not involve controlled substances may constitute grounds for 
the revocation of a DEA registration pursuant to 21 U.S.C. 
824(a)(5).''); Stanley Dubin, D.D.S., 61 FR 60,727, 60,728 (1996) 
(Registration revoked and pending applications for renewal denied when 
registrant's ``actions cast substantial doubt on . . . [his] 
integrity.''); George D. Osafo, M.D., 58 FR 37,508, 37,509 (1993) 
(Submission of fraudulent medical claims and larceny convictions 
indicated that registrant ``placed monetary gain above the welfare of 
his patients, and in so doing, endangered the public health and 
safety.'').
    Under 42 U.S.C. 1320a-7(a)(1), the HHS OIG is required to exclude 
from participation in any Federal health care program any individual 
who has been convicted of a criminal offense ``related to the delivery 
of an item or service under . . . [42 U.S.C. 1395 et seq.] or under any 
State health care program.'' Based on the uncontroverted evidence in 
the record, as already discussed, I found that Respondent has been 
excluded from participation in any capacity in Medicare, Medicaid, and 
all Federal health care programs and that Respondent is still excluded 
from participation in these programs. Accordingly, I find that the 
evidence in the record satisfies the Government's prima facie burden to 
support the revocation of Respondent's registration under 21 U.S.C. 
824(a)(5).

Sanction

    Where, as here, the Government has met its prima facie burden, the 
burden shifts to Respondent to show why he can be entrusted with a 
registration. Respondent, however, did not submit evidence for the 
record. Instead, he stated that the documents are self-explanatory, 
that he ``will not make any statement regarding this administrative 
action,'' and that ``[t]he issue is hereby submitted for final 
ruling.'' R.D., at 7. Thus, the question now is whether revocation is 
the appropriate sanction under the facts I have found: Two separate 
violations whose statutory sanctions include revocation. 21 U.S.C. 
824(a)(1) and (5).
    I agree with the ALJ's analysis and conclude that revocation is 
independently the appropriate sanction for each of the separate 
violations the facts support. In particular, I agree with the ALJ's 
analysis that, even though the underlying misconduct which led to 
Respondent's conviction and mandatory exclusion did not involve 
controlled substances, it did involve the unlawful use of Respondent's 
prescribing authority. R.D., at 17. As the ALJ stated, ``This type of 
fraudulent behavior does not inspire confidence that . . . [Respondent] 
can be trusted with a prescription pad bearing a DEA registration 
number.'' Id. After all, if Respondent signed blank certificates of 
medical necessity for durable medical equipment that was not medically 
necessary, ``it is doubtful that DEA can expect . . . [Respondent] to 
honestly prescribe controlled substances for only legitimate medical 
purposes.'' Id.
    Further, Respondent materially falsified two DEA applications. One 
such falsification, alone, is sufficient, without proof of any other 
misconduct, to revoke a registration. Toret, supra, 82 FR at 60,043. As 
the ALJ stated, ``[N]ot only has the Government proven two independent 
bases for revoking . . . [Respondent's] registration . . ., but . . . 
[Respondent] has not advanced any evidence that he `can be trusted to 
responsibly discharge his obligations as a registrant.' '' R.D., at 17-
18 (citation omitted).
    Accordingly, based on the evidence in the record supporting two 
independent bases for revocation, I shall order that Respondent's DEA 
registration be revoked and that any pending application of Respondent 
to renew or to modify that registration be denied.

Order

    Pursuant to 28 CFR 0.100(b) and the authority thus vested in me by 
21 U.S.C. 824(a), I order that DEA Certificate of Registration No. 
FR4900305 issued to Narciso A. Reyes, M.D., be, and it hereby is, 
revoked. Pursuant to 28 CFR 0.100(b) and the authority thus vested in 
me by 21 U.S.C. 823(f), I further order that any pending application of 
Narciso A. Reyes, M.D., to renew or to modify this registration, be, 
and it hereby is, denied. This Order is effective December 31, 2018.

    Dated: November 19, 2018.
 Uttam Dhillon,
Acting Administrator.
[FR Doc. 2018-26047 Filed 11-29-18; 8:45 am]
 BILLING CODE 4410-09-P



                                              61678                       Federal Register / Vol. 83, No. 231 / Friday, November 30, 2018 / Notices

                                              Where a registrant has lost state authority to          R.D., at 3–4.                                         DEPARTMENT OF JUSTICE
                                              handle controlled substances, the Agency has               It is undisputed that Respondent is
                                              repeatedly taken the position that                      not currently authorized to practice                  Drug Enforcement Administration
                                              ‘‘revocation is warranted even where a                  medicine in Arizona due to the Interim
                                              practitioner’s state authority has been                                                                       [Docket No. 18–32]
                                              summarily suspended and the State has yet
                                                                                                      Consent Agreement. Thus, according to
                                              to provide the practitioner with a hearing to           Arizona law, Respondent does not have                 Narciso A. Reyes, M.D.; Decision and
                                              challenge the State’s action and at which he            authority to handle controlled                        Order
                                              . . . may ultimately prevail.’’ Kamal Tiwari,           substances in Arizona, the State in
                                              M.D., 76 FR 71604, 71606 (2011) (citations              which he is registered with the DEA. As                  On April 19, 2018, the Assistant
                                              omitted); see also Anne Lazar Thorn, M.D.,              already discussed, the practice                       Administrator, Diversion Control
                                              62 FR 12847, 12848 (1997) (‘‘[T]he                      restriction on Respondent’s medical                   Division, Drug Enforcement
                                              controlling question is not whether a                   license is currently in effect. DEA has               Administration (hereinafter, DEA or
                                              practitioner’s license to practice medicine in                                                                Government), issued an Order to Show
                                              the state is suspended or revoked; rather, it
                                                                                                      ‘‘long and consistently interpreted the
                                                                                                      CSA as mandating the possession of                    Cause to Narciso A. Reyes, M.D.
                                              is whether the Respondent is currently
                                              authorized to handle controlled substances in           authority under state law to handle                   (hereinafter, Respondent), of Luquillo,
                                              the [state of registration].’’). Even when the          controlled substances as a fundamental                Puerto Rico. Order to Show Cause
                                              Respondent is actively engaged in appealing             condition for obtaining and maintaining               (hereinafter, OSC), at 1. The Show
                                              a state decision, the Agency has noted that             a registration.’’ Hooper, supra, 76 FR at             Cause Order proposes the revocation of
                                              ‘‘[i]t is not DEA’s policy to stay                      71,371. That is the controlling question.             Respondent’s DEA Certificate of
                                              [administrative] proceedings . . . while                Thorn, supra, 62 FR at 12,848. The CSA                Registration on the grounds that he
                                              registrants litigate in other forums.’’ Newcare                                                               materially falsified applications he
                                              Home Health Servs., 72 FR 42126, 42127 n.2              has consistently been interpreted to
                                                                                                      mean that ‘‘DEA does not have statutory               submitted to DEA and that he has been
                                              (2007). Agency precedent has consistently
                                              affirmed recommended decisions where a                  authority . . . to maintain a registration            excluded from participation in a
                                              respondent’s request for a stay due to state            if the registrant is without state                    program pursuant to 42 U.S.C. 1320a–
                                              medical board proceedings were denied by                authority to handle controlled                        7(a). Id. (citing 21 U.S.C. 824(a)(1) and
                                              the Administrative Law Judge. See, e.g., Irwin          substances in the state in which he                   (5)). It also proposes the denial of ‘‘any
                                              August, D.O., 81 FR 3158, 3159 (2016); Pedro            practices.’’ Yeates, supra, 71 FR at                  applications for renewal or modification
                                              E. Lopez, M.D., 80 FR 46324, 46325–26                                                                         of such registration and any
                                              (2015). The Agency has stated in recent final
                                                                                                      39,131. As succinctly explained by the
                                                                                                      CALJ, ‘‘The DEA has long held that                    applications for any other DEA
                                              orders that a stay in administrative                                                                          registration.’’ OSC, at 1 (citing 21 U.S.C.
                                              enforcement proceedings is ‘‘unlikely to ever           possession of authority under state law
                                              be justified’’ due to ancillary proceedings             to dispense controlled substances is not              824(a)(1) and (5)).
                                              involving the Respondent. Grider Drug #1 &              only a prerequisite to obtaining a DEA                   Regarding jurisdiction, the Show
                                              Grider Drug #2, 77 FR 44070, 44104 n.97                 registration, but also an essential                   Cause Order alleges that Respondent
                                              (2012).                                                 condition for maintaining it.’’ R.D., at 5            holds DEA Certificate of Registration
                                                 Even if the Agency’s precedent were not
                                                                                                      (citations omitted). I agree with the                 No. FR4900305 at the registered address
                                              fixed firmly against the granting of such a                                                                   of Calle Fernandez Garcia 306, Luquillo,
                                              delay in principle, the Respondent here is              CALJ’s conclusion that ‘‘as a matter of
                                                                                                      law, a DEA registration may not be                    Puerto Rico 00773, with a mailing
                                              unable to point to a reliably fixed date where                                                                address of P.O. Box 247, Luquillo, PR
                                              state proceedings would reasonably be                   granted or maintained where an
                                              concluded. The Respondent’s Motion                      applicant/registrant no longer falls                  00773. OSC, at 2. This registration, the
                                              includes a Declaration from the Respondent’s            within the CSA’s definition of a                      OSC alleges, authorizes Respondent to
                                              counsel (Respondent’s Board Counsel) in his             practitioner.’’ Id. Very simply, since                dispense controlled substances in
                                              Arizona Board proceedings. . . .                        Respondent is not authorized to handle                schedules II through V as a practitioner.
                                              [Respondent’s Motion,] Attachment 1. In the                                                                   Id. The Show Cause Order alleges that
                                              Respondent’s Board Counsel’s declaration,               controlled substances in Arizona, he is
                                                                                                      not eligible for a DEA registration. As               this registration expires on April 30,
                                              the decisional timeframe is couched in the                                                                    2020. Id.
                                              following tenuous terms:                                such, I will order that Respondent’s
                                                                                                                                                               Regarding the substantive grounds for
                                                 As for when the [Arizona Board] might                DEA registration be revoked.
                                              take action, my best guess is that it will be                                                                 the proceeding, the Show Cause Order
                                              at its August 20, 2018 meeting, although I              Order                                                 alleges that, on October 20, 2009, the
                                              would not be surprised if [the Respondent’s]               Pursuant to 28 CFR 0.100(b) and the                U.S. Department of Health and Human
                                              matter is not heard until the October 22                authority thus vested in me by 21 U.S.C.              Services, Office of Inspector General
                                              meeting, which is the next regularly                    824(a), I order that DEA Certificate of               (hereinafter, HHS/OIG), mandatorily
                                              scheduled meeting of the [Arizona Board].                                                                     excluded Respondent from participating
                                                                                                      Registration No. BF3649312 issued to
                                              Id. at 2–3 (emphasis supplied). The                     Steve Fanto, M.D., be, and it hereby is,              in all Federal health care programs due
                                              Respondent’s Board Counsel further                                                                            to his conviction in U.S. District Court
                                              explained that the state process involves the           revoked. Pursuant to 28 CFR 0.100(b)
                                                                                                      and the authority thus vested in me by                for conspiracy to commit health care
                                              actions and recommendations of an internal
                                                                                                      21 U.S.C. 823(f), I further order that any            fraud. Id. at 2 (citing 42 U.S.C. 1320a–
                                              committee, and avers that he and the
                                              Respondent ‘‘are hopeful that [the internal             pending application of Steve Fanto,                   7(a)(1)). According to the OSC,
                                              committee] will make those                              M.D., to renew or modify this                         Respondent’s ‘‘mandatory exclusion
                                              recommendations and share them with us in               registration, as well as any other                    from Medicare, Medicaid and all
                                              the not-too-distant future and if that occurs           pending application by him for                        Federal health care programs warrants
                                              then the matter should be heard at the                  registration in the State of Arizona, be,             revocation of . . . [his] registration.’’
                                              August 20 meeting.’’ Id. at 3 (emphasis                                                                       OSC, at 2 (citing 21 U.S.C. 824(a)(5)).
amozie on DSK3GDR082PROD with NOTICES1




                                              supplied). While the candor of the                      and it hereby is, denied. This order is
                                                                                                      effective December 31, 2018.                             The Show Cause Order further alleges
                                              Respondent’s Board Counsel is                                                                                 that Respondent provided false answers
                                              commendable, the language strikes as too                  Dated: November 19, 2018.
                                              aspirational and amorphous to be
                                                                                                                                                            to two ‘‘yes’’ or ‘‘no’’ liability questions
                                                                                                      Uttam Dhillon,                                        when he applied for a DEA registration
                                              particularly supportive of the delay sought by
                                              the Respondent here—even if the Agency’s                Acting Administrator.                                 on October 16, 2014 and when he filed
                                              precedent were not squarely opposed to the              [FR Doc. 2018–26046 Filed 11–29–18; 8:45 am]          a renewal application on April 17, 2017.
                                              relief—which it is.                                     BILLING CODE 4410–09–P                                OSC, at 2–3. Specifically, the Show


                                         VerDate Sep<11>2014   17:00 Nov 29, 2018   Jkt 247001   PO 00000   Frm 00080   Fmt 4703   Sfmt 4703   E:\FR\FM\30NON1.SGM   30NON1


                                                                          Federal Register / Vol. 83, No. 231 / Friday, November 30, 2018 / Notices                                            61679

                                              Cause Order alleges that Respondent                     dispose of this matter without a hearing and          Nov. 3, 2008)), at 1. According to the
                                              twice answered that he had never been                   recommend to the Acting Administrator that            facts submitted by the Assistant United
                                              excluded from participation in a                        . . . [Respondent’s] DEA registration be              States Attorney and explicitly adopted
                                              Medicare or state health care program                   revoked. On the same day, I issued an Order           by Respondent, Respondent signed
                                                                                                      affording . . . [Respondent] the opportunity
                                              when, in fact, he had been. Id. at 2–3.                 to respond to the Government’s Motion by
                                                                                                                                                            blank or previously completed false
                                              The Show Cause Order also alleges that                  June 14, 2018. I explained that if . . .              Certificates of Medical Necessity for
                                              Respondent twice answered that he had                   [Respondent] disagreed with any of the                durable medical equipment for
                                              never surrendered (for cause) a Federal                 Government’s statements of undisputed                 Medicare beneficiaries whom he had
                                              controlled substance registration when,                 material facts as outlined in its motion for          never seen. Id. at 9. The Federal District
                                              in fact, he had. Id. at 3. According to the             summary disposition, he should provide                Judge entered judgment against
                                              OSC, Respondent’s answers to these                      copies of documentary evidence refuting the           Respondent on March 13, 2009.
                                              liability questions are ‘‘material                      Government’s statement(s). I further directed         Government’s Motion, GE–3 (Judgment,
                                              falsifications’’ that warrant revocation of             . . . [Respondent] to identify the material           United States v. Reyes Carrillo, No. 08–
                                              his registration. Id.                                   fact(s) which justify an evidentiary hearing in       cr–168–03 (D. P.R. March 13, 2009)), at
                                                 The Show Cause Order notifies                        this case. . . . [Respondent] failed to
                                                                                                      respond to the Government’s Motion by the
                                                                                                                                                            1.
                                              Respondent of his right to request a                    deadline on June 14, 2018.
                                                                                                                                                               Based on Respondent’s conviction for
                                              hearing on the allegations or to submit                    On June 15, 2018, the day after . . .              conspiracy to commit health care fraud,
                                              a written statement while waiving his                   [Respondent’s] Response was due, chambers             the HHS/OIG notified Respondent of his
                                              right to a hearing, the procedures for                  staff emailed . . . [Respondent’s] counsel            mandatory exclusion from participation
                                              electing each option, and the                           notifying him that the OALJ had not received          in any capacity in Medicare, Medicaid,
                                              consequences for failing to elect either                a response from him and asking whether he             and all Federal health care programs for
                                              option. Id. at 3–4 (citing 21 CFR                       intended to submit a late filing. . . .               the minimum statutory period of five
                                              1301.43). The Show Cause Order also                     [Respondent’s] counsel replied by email on            years effective October 20, 2009.
                                              notifies Respondent of the opportunity                  June 17, 2018, with the following statement:          Government’s Motion, GE–4 (HHS/OIG
                                              to submit a corrective action plan. OSC,                ‘‘There are no allegations on behalf of . . .         Exclusion Letter), at 1 (citing 42 U.S.C.
                                                                                                      [Respondent]. The documents are self
                                              at 4–5 (citing 21 U.S.C. 824(c)(2)(C)).                 [e]xplanatory.’’
                                                                                                                                                            1320a–7(a)); Government’s Motion, GE–
                                                 Respondent timely requested a                           Then, on June 21, 2018, the OALJ received          5 (HHS/OIG Exclusions Search Results:
                                              hearing on May 21, 2018.1 Hearing                       a filing from . . . [Respondent’s] counsel            Verify), at 1. The HHS/OIG Exclusion
                                              Request, at 1. In his Hearing Request,                  titled ‘‘Statement of Narciso A. Reyes, M.D.’’        Letter advised Respondent that
                                              Respondent states that, ‘‘It was not my                 The filing states that . . . [Respondent] ‘‘will      reinstatement of eligibility to participate
                                              intention to fail to declare a material                 not make any statement regarding this                 in these programs is not automatic.
                                              fact in the request for renewal . . . . I               administrative action’’ and that ‘‘[t]he issue        Government’s Motion, GE–4, at 2.
                                              do not master the English language well                 is hereby submitted for final ruling.’’               Respondent is still excluded from
                                              and this may have contributed to these                  R.D., at 2–3, 7.                                      participation in these programs.
                                              errors.’’ Id. He also states in his Hearing                The ALJ correctly concluded that                   Government’s Motion, GE–5, at 1.
                                              Request that, ‘‘My inclusion of the word                Respondent’s choice not to refute,                    Respondent’s DEA Registration History
                                              N in the renewal request was in my                      challenge, or even address any of the                 and Current Registration Status
                                              estimate to indicate that it did not apply              Government’s reliable and probative
                                              since I had reached an agreement with                   evidence and legal arguments ‘‘strongly                  On January 31, 2013, Respondent
                                              the US Attorney’s Office in Puerto Rico.                indicates that he no longer wishes to                 voluntarily surrendered for cause DEA
                                              Clearly my mistake.’’ Id.                               proceed to hearing.’’ Id. at 10. After                registration No. BR3465944.
                                                 The Office of Administrative Law                     analyzing the Government’s evidence                   Government’s Motion, GE–8
                                              Judges (hereinafter, OALJ) put the                      and legal argument, the ALJ granted the               (Respondent’s DEA–104 Voluntary
                                              matter on the docket and assigned it to                 Government’s Motion for Summary                       Surrender of Controlled Substances
                                              Administrative Law Judge Charles Wm.                    Disposition and recommended that I                    Privileges), at 1; Government’s Motion,
                                              Dorman (hereinafter, ALJ). I adopt the                  revoke Respondent’s registration and                  GE–9 (Certification of Registration
                                              following statement of procedural                       deny any pending applications for                     History), at 1. Neither the DEA–104 nor
                                              history from the ALJ’s Order Granting                   renewal or modification. Id. at 10, 18.               any other evidence in the record
                                              the Government’s Motion for Summary                        By letter dated July 16, 2018, the ALJ             explains the context of this voluntary
                                              Disposition and Recommended Rulings,                    certified and transmitted the record to               surrender. DEA retired registration No.
                                              Findings of Fact, Conclusions of Law,                   me for final Agency action. In that letter,           BR3465944 on February 4, 2013.
                                              and Decision dated June 22, 2018                        the ALJ advised that neither party filed              Government’s Motion, GE–9, at 1.
                                              (hereinafter, R.D.).                                                                                             On October 16, 2014, Respondent
                                                                                                      exceptions and that the time period to
                                                                                                                                                            submitted an application for a new DEA
                                                 On May 31, 2018, the Government filed a              do so had expired.
                                              Motion for Summary Disposition                                                                                registration. Government’s Motion, GE–
                                                                                                         I issue this Decision and Order based
                                              (‘‘Government’s Motion’’). The Government’s                                                                   10 (Respondent’s DEA Form 224
                                                                                                      on the entire record before me. 21 CFR
                                              Motion argued that there is no issue of                                                                       submitted on October 16, 2014), at 1.
                                                                                                      1301.43(e). I make the following
                                              material fact in this case to warrant an                                                                      The application Respondent completed
                                              adversarial hearing. The Government’s                   findings of fact.
                                                                                                                                                            includes ‘‘yes’’ or ‘‘no’’ liability
                                              Motion further requested that I summarily               Findings of Fact                                      questions that an applicant must answer
                                                                                                                                                            to advance to the next page of the online
                                                1 Attached to the Government’s Notice of Service      Respondent’s Criminal Conviction and
                                                                                                                                                            DEA application. Government’s Motion,
amozie on DSK3GDR082PROD with NOTICES1




                                              of Order to Show Cause is a DEA–12 (Receipt for         Ensuing Mandatory Exclusion
                                              Cash or Other Items) that, according to the                                                                   GE–l (Certification of Registration
                                              Government’s allegations, Respondent executed             On November 3, 2008, Respondent                     Status), at 2; Government’s Motion, GE–
                                              when the Government served the OSC on April 23,         pled guilty in Federal District Court to              10, at 1.
                                              2018. Respondent did challenge the Government’s         one count of conspiracy to commit                        The first liability question that
                                              service-related allegations. Thus, I find that
                                              Respondent’s Hearing Request was timely since it
                                                                                                      health care fraud. Government’s Motion,               Respondent answered on his online
                                              was filed within 30 days of service of the OSC. 21      GE–2 (Plea Agreement, United States v.                DEA application for a registration asks:
                                              CFR 1301.43(a).                                         Reyes Carrillo, No. 08–cr–168 (D. P.R.                ‘‘Has the applicant ever been convicted


                                         VerDate Sep<11>2014   17:00 Nov 29, 2018   Jkt 247001   PO 00000   Frm 00081   Fmt 4703   Sfmt 4703   E:\FR\FM\30NON1.SGM   30NON1


                                              61680                       Federal Register / Vol. 83, No. 231 / Friday, November 30, 2018 / Notices

                                              of a crime in connection with controlled                question. Government’s Motion, GE–1,                  Weinstock v. United States, 231 F.2d
                                              substance(s) under state or federal law,                at 1; Government’s Motion, GE–11, at 1.               699, 701–02 (D.C. Cir. 1956) (other
                                              or been excluded or directed to be                      Again, the HHS/OIG Exclusion letter                   citation omitted)). The Court explicitly
                                              excluded from participation in a                        makes it clear that Respondent knew or                addressed what has ‘‘never been the test
                                              medicare or state health care program,                  should have known that his ‘‘no’’                     of materiality[—] that the
                                              or [is] any such action pending?’’                      response to this question was false.                  misrepresentation or concealment
                                              Government’s Motion, GE–1, at 2;                        Government’s Motion, GE–4, at 1–2.                    would more likely than not have
                                              Government’s Motion, GE–10, at 1.                          The second liability question that                 produced an erroneous decision, or
                                              Respondent answered ‘‘no’’ to this                      Respondent answered on his online                     even that it would more likely than not
                                              question. Government’s Motion, GE–1,                    DEA renewal application asks: ‘‘Has the               have triggered an investigation.’’
                                              at 2; Government’s Motion, GE–10, at 1.                 applicant ever surrendered (for cause) or             Kungys, supra, 485 U.S. at 771
                                              The HHS/OIG Exclusion letter makes it                   had a federal controlled substance                    (emphasis in original). Instead, the
                                              clear that Respondent knew or should                    registration revoked, suspended,                      Court articulated the specific test as
                                              have known that his ‘‘no’’ response to                  restricted or denied, or is any such                  ‘‘whether the misrepresentation or
                                              this question was false. Government’s                   action pending?’’ Government’s Motion,                concealment was predictably capable of
                                              Motion, GE–4, at 1–2.                                   GE–l, at 1; Government’s Motion, GE–                  affecting, i.e., had a natural tendency to
                                                 The second liability question that                   11, at 1. Respondent answered ‘‘no’’ to               affect, the official decision.’’ Id.
                                              Respondent answered on his online                       this question. Government’s Motion,                      As already discussed, when
                                              DEA application for a registration asks:                GE–1, at 1; Government’s Motion, GE–                  Respondent submitted an online DEA
                                              ‘‘Has the applicant ever surrendered (for               11, at 1. Again, the DEA–104 Voluntary                application for a registration and an
                                              cause) or had a federal controlled                      Surrender of Controlled Substances                    online DEA renewal application, he
                                              substance registration revoked,                         Privileges form that Respondent signed                answered ‘‘no’’ to whether he had ever
                                              suspended, restricted or denied, or is                  makes it clear that Respondent knew or                been excluded from participation in
                                              any such action pending?’’                              should have known that his ‘‘no’’                     Medicare and to whether he had ever
                                              Government’s Motion, GE–l, at 2;                        response to this question was false.                  surrendered a registration for cause. As
                                              Government’s Motion, GE–10, at 1.                       Government’s Motion, GE–8, at 1.                      I already found above, Respondent’s
                                              Respondent answered ‘‘no’’ to this                         DEA approved Respondent’s renewal                  four answers were false and he ‘‘knew
                                              question. Government’s Motion, GE–1,                    application on April 19, 2017.                        or should have known’’ that they were
                                              at 2; Government’s Motion, GE–10, at 1.                 Government’s Motion, GE–1, at 1.                      false.
                                              The DEA–104 Voluntary Surrender of                         In sum, Respondent is currently                       I next determine the ‘‘materiality’’ of
                                              Controlled Substances Privileges form                   registered as a practitioner in schedules             Respondent’s four answers. 21 U.S.C.
                                              that Respondent signed, however,                        II through V under DEA Certificate of                 824(a)(1). Concerning Respondent’s
                                              makes it clear that Respondent knew or                  Registration FR4900305 at Calle                       false statements about his voluntary
                                              should have known that his ‘‘no’’                       Fernandez Garcia 306, Luquillo, Puerto                surrender of DEA registration No.
                                              response to this question was false.                    Rico 00773. Government’s Motion, GE–                  BR3465944, the DEA–104 that
                                              Government’s Motion, GE–8, at 1.                        1, at 1. Respondent’s registration expires            Respondent executed does not indicate
                                                 DEA approved Respondent’s                            on April 30, 2020. Id.                                the underlying reason(s) for
                                              application and, on October 17, 2014,                                                                         Respondent’s ‘‘alleged failure to comply
                                              assigned DEA Certificate of Registration                Discussion                                            with the Federal requirements
                                              No. FR4900305 to him. Government’s                      The Material Falsification Allegation                 pertaining to controlled substances.’’
                                              Motion, GE–1, at 1.                                                                                           Government’s Motion, GE–8, at 1.
                                                 On April 17, 2017, Respondent                           Pursuant to 21 U.S.C. 824(a)(1), the               Further, as the ALJ noted, the DEA–104
                                              submitted an online DEA renewal                         Attorney General may suspend or                       reveals nothing about whether
                                              application for his DEA registration No.                revoke a registration issued under                    Respondent’s ‘‘alleged failure’’ ‘‘had a
                                              FR4900305. Government’s Motion, GE–                     section 823 of Title 21, ‘‘upon a finding             natural tendency to affect’’ an Agency
                                              1, at 1; Government’s Motion, GE–11                     that the registrant . . . has materially              decision. R.D., at 13–14 (quoting Michel
                                              (Respondent’s DEA Form 224A                             falsified any application filed pursuant              P. Toret, M.D., 82 FR 60,041, 60,043
                                              submitted on April 17, 2017), at 1. The                 to or required by this subchapter.’’                  (2017) quoting Kungys, supra, 485 U.S.
                                              online DEA renewal application                          According to Agency precedent, the                    at 771). I found no evidence in the
                                              Respondent submitted includes ‘‘yes’’ or                Government must show that a                           record concerning the materiality of
                                              ‘‘no’’ liability questions that an                      respondent ‘‘knew or should have                      Respondent’s two false answers about
                                              applicant must answer to advance to the                 known’’ that his response to a liability              his voluntary surrender. Thus, I agree
                                              next page of the online DEA renewal                     question was false. Samuel S. Jackson,                with the ALJ that the record does not
                                              application. Government’s Motion, GE–                   D.D.S., 72 FR 23,848, 23,852 (2007).                  support a finding that Respondent’s two
                                              l, at 1; Government’s Motion, GE–11, at                 Also according to Agency precedent, a                 false answers about his voluntary
                                              1.                                                      respondent’s claim that he                            surrender of registration No. BR3465944
                                                 The first liability question that                    misunderstood a liability question is not             were ‘‘materially’’ false. 21 U.S.C.
                                              Respondent answered on his online                       a defense. Alvin Darby, M.D., 75 FR                   824(a)(1).
                                              DEA renewal application asks: ‘‘Has the                 26,993, 26,999 (2010).                                   Concerning Respondent’s false
                                              applicant ever been convicted of a crime                   According to the Supreme Court,                    statements regarding his mandatory
                                              in connection with controlled                           Federal courts’ ‘‘most common                         exclusion, the Agency has never before
                                              substance(s) under state or federal law,                formulation’’ of the concept of                       considered the materiality of a
amozie on DSK3GDR082PROD with NOTICES1




                                              or been excluded or directed to be                      ‘‘materiality’’ is that ‘‘a concealment or            respondent’s false answers about his
                                              excluded from participation in a                        misrepresentation is material if it ‘has a            mandatory exclusion as that question is
                                              medicare or state health care program,                  natural tendency to influence, or was                 posed in this case. I find the ALJ’s
                                              or [is] any such action pending?’’                      capable of influencing, the decision of’              analysis persuasive: ‘‘Considering that
                                              Government’s Motion, GE–1, at 1;                        the decisionmaking body to which it                   exclusion from a federal health care
                                              Government’s Motion, GE–11, at 1.                       was addressed.’’ Kungys v. United                     program under 42 U.S.C. 1320a–7(a) is
                                              Respondent answered ‘‘no’’ to this                      States, 485 U.S. 759, 770 (1988) (quoting             an independent basis for revoking [a]


                                         VerDate Sep<11>2014   17:00 Nov 29, 2018   Jkt 247001   PO 00000   Frm 00082   Fmt 4703   Sfmt 4703   E:\FR\FM\30NON1.SGM   30NON1


                                                                          Federal Register / Vol. 83, No. 231 / Friday, November 30, 2018 / Notices                                                61681

                                              registration . . ., it is reasonable to                 capacity in Medicare, Medicaid, and all               Respondent’s DEA registration be
                                              conclude that information regarding an                  Federal health care programs and that                 revoked and that any pending
                                              applicant’s mandatory exclusion by                      Respondent is still excluded from                     application of Respondent to renew or
                                              HHS would be ‘capable of influencing                    participation in these programs.                      to modify that registration be denied.
                                              the [DEA’s] decision.’ ’’ R.D., at 13                   Accordingly, I find that the evidence in
                                                                                                                                                            Order
                                              (citations omitted). I agree with the ALJ.              the record satisfies the Government’s
                                              I find that Respondent’s failure to                     prima facie burden to support the                       Pursuant to 28 CFR 0.100(b) and the
                                              disclose his mandatory exclusion from a                 revocation of Respondent’s registration               authority thus vested in me by 21 U.S.C.
                                              Federal health care program is material.                under 21 U.S.C. 824(a)(5).                            824(a), I order that DEA Certificate of
                                              Id. Thus, I find that there is substantial                                                                    Registration No. FR4900305 issued to
                                                                                                      Sanction                                              Narciso A. Reyes, M.D., be, and it
                                              evidence in the record that Respondent
                                              materially falsified a DEA registration                    Where, as here, the Government has                 hereby is, revoked. Pursuant to 28 CFR
                                              application and a DEA registration                      met its prima facie burden, the burden                0.100(b) and the authority thus vested in
                                              renewal application concerning his                      shifts to Respondent to show why he                   me by 21 U.S.C. 823(f), I further order
                                              mandatory exclusion. 21 U.S.C.                          can be entrusted with a registration.                 that any pending application of Narciso
                                              824(a)(1).                                              Respondent, however, did not submit                   A. Reyes, M.D., to renew or to modify
                                                                                                      evidence for the record. Instead, he                  this registration, be, and it hereby is,
                                              The Allegation of Mandatory Exclusion                   stated that the documents are self-                   denied. This Order is effective
                                              From a Federal Health Care Program                      explanatory, that he ‘‘will not make any              December 31, 2018.
                                                 Pursuant to 21 U.S.C. 824(a)(5), the                 statement regarding this administrative
                                                                                                                                                              Dated: November 19, 2018.
                                              Attorney General may suspend or                         action,’’ and that ‘‘[t]he issue is hereby
                                              revoke a registration issued under                      submitted for final ruling.’’ R.D., at 7.             Uttam Dhillon,
                                              section 823 of Title 21, ‘‘upon a finding               Thus, the question now is whether                     Acting Administrator.
                                              that the registrant . . . has been                      revocation is the appropriate sanction                [FR Doc. 2018–26047 Filed 11–29–18; 8:45 am]
                                              excluded . . . from participation in a                  under the facts I have found: Two                     BILLING CODE 4410–09–P
                                              program pursuant to section 1320a–7(a)                  separate violations whose statutory
                                              of Title 42.’’ Agency precedent makes                   sanctions include revocation. 21 U.S.C.
                                              clear that revocation under 21 U.S.C.                   824(a)(1) and (5).                                    DEPARTMENT OF JUSTICE
                                              824(a)(5) may be appropriate regardless                    I agree with the ALJ’s analysis and
                                              of whether or not the misconduct that                   conclude that revocation is                           Office of Justice Programs
                                              led to the mandatory exclusion involved                 independently the appropriate sanction                [OJP (OJJDP) Docket No. 1752]
                                              controlled substances. KK Pharmacy, 64                  for each of the separate violations the
                                              FR 49,507, 49,510 (1999) (collecting                    facts support. In particular, I agree with            Meeting of the Coordinating Council
                                              cases) (The Agency ‘‘has previously                     the ALJ’s analysis that, even though the              on Juvenile Justice and Delinquency
                                              held that misconduct which does not                     underlying misconduct which led to                    Prevention
                                              involve controlled substances may                       Respondent’s conviction and mandatory
                                                                                                                                                            AGENCY:  Coordinating Council on
                                              constitute grounds, under 21 U.S.C.                     exclusion did not involve controlled
                                                                                                                                                            Juvenile Justice and Delinquency
                                              824(a)(5), for the revocation of a DEA                  substances, it did involve the unlawful
                                                                                                                                                            Prevention, Office of Justice Programs,
                                              Certificate of Registration.’’); Melvin N.              use of Respondent’s prescribing
                                                                                                                                                            Department of Justice.
                                              Seglin, M.D., 63 FR 70,431, 70,433                      authority. R.D., at 17. As the ALJ stated,
                                                                                                      ‘‘This type of fraudulent behavior does               ACTION: Notice of meeting.
                                              (1998) (‘‘[M]isconduct which does not
                                              involve controlled substances may                       not inspire confidence that . . .                     SUMMARY:   The Coordinating Council on
                                              constitute grounds for the revocation of                [Respondent] can be trusted with a                    Juvenile Justice and Delinquency
                                              a DEA registration pursuant to 21 U.S.C.                prescription pad bearing a DEA                        Prevention announces its next meeting.
                                              824(a)(5).’’); Stanley Dubin, D.D.S., 61                registration number.’’ Id. After all, if
                                                                                                                                                            DATES: Wednesday, December 19, 2018
                                              FR 60,727, 60,728 (1996) (Registration                  Respondent signed blank certificates of
                                                                                                                                                            at 10 a.m. EST.
                                              revoked and pending applications for                    medical necessity for durable medical
                                                                                                                                                            ADDRESSES: The meeting will take place
                                              renewal denied when registrant’s                        equipment that was not medically
                                              ‘‘actions cast substantial doubt on . . .               necessary, ‘‘it is doubtful that DEA can              in the third floor main conference room
                                              [his] integrity.’’); George D. Osafo, M.D.,             expect . . . [Respondent] to honestly                 at the U.S. Department of Justice, Office
                                              58 FR 37,508, 37,509 (1993)                             prescribe controlled substances for only              of Justice Programs, 810 7th St. NW,
                                              (Submission of fraudulent medical                       legitimate medical purposes.’’ Id.                    Washington, DC 20531.
                                              claims and larceny convictions                             Further, Respondent materially                     FOR FURTHER INFORMATION CONTACT: Visit
                                              indicated that registrant ‘‘placed                      falsified two DEA applications. One                   the website for the Coordinating Council
                                              monetary gain above the welfare of his                  such falsification, alone, is sufficient,             at www.juvenilecouncil.gov or contact
                                              patients, and in so doing, endangered                   without proof of any other misconduct,                Jeff Slowikowski, Designated Federal
                                              the public health and safety.’’).                       to revoke a registration. Toret, supra, 82            Official (DFO), OJJDP, by telephone at
                                                 Under 42 U.S.C. 1320a–7(a)(1), the                   FR at 60,043. As the ALJ stated, ‘‘[N]ot              (202) 616–3646, email at
                                              HHS OIG is required to exclude from                     only has the Government proven two                    jeff.slowikowski@usdoj.gov, or fax at
                                              participation in any Federal health care                independent bases for revoking . . .                  (202) 353–9093; or Sarah Wisniewski,
                                              program any individual who has been                     [Respondent’s] registration . . ., but                Senior Program Manager/Federal
                                              convicted of a criminal offense ‘‘related               . . . [Respondent] has not advanced any               Contractor, by telephone (202) 305–
amozie on DSK3GDR082PROD with NOTICES1




                                              to the delivery of an item or service                   evidence that he ‘can be trusted to                   9017, email at sarah.wisniewski@
                                              under . . . [42 U.S.C. 1395 et seq.] or                 responsibly discharge his obligations as              usdoj.gov, or fax at (866) 854–6619.
                                              under any State health care program.’’                  a registrant.’ ’’ R.D., at 17–18 (citation            Please note that the above phone/fax
                                              Based on the uncontroverted evidence                    omitted).                                             numbers are not toll free.
                                              in the record, as already discussed, I                     Accordingly, based on the evidence in              SUPPLEMENTARY INFORMATION: The
                                              found that Respondent has been                          the record supporting two independent                 Coordinating Council on Juvenile
                                              excluded from participation in any                      bases for revocation, I shall order that              Justice and Delinquency Prevention


                                         VerDate Sep<11>2014   17:00 Nov 29, 2018   Jkt 247001   PO 00000   Frm 00083   Fmt 4703   Sfmt 4703   E:\FR\FM\30NON1.SGM   30NON1



Document Created: 2018-11-30 04:35:41
Document Modified: 2018-11-30 04:35:41
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 Citation83 FR 61678 

2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR