Frank Joseph Stirlacci, M.D.; Decision and Order

Cited as:85 FR 45229
Court:Drug Enforcement Administration
Publication Date:27 Jul 2020
Record Number:2020-16193
Federal Register, Volume 85 Issue 144 (Monday, July 27, 2020)
[Federal Register Volume 85, Number 144 (Monday, July 27, 2020)]
                [Notices]
                [Pages 45229-45240]
                From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
                [FR Doc No: 2020-16193]
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                DEPARTMENT OF JUSTICE
                Drug Enforcement Administration
                [Docket No. 17-29]
                Frank Joseph Stirlacci, M.D.; Decision and Order
                I. Introduction
                 On April 5, 2017, the then-Assistant Administrator, Diversion
                Control Division, Drug Enforcement Administration (hereinafter, DEA or
                Government), issued an Order to Show Cause to Frank Joseph Stirlacci,
                M.D. (hereinafter, Respondent), of Agawam, Massachusetts and Hammond,
                Indiana. Administrative Law Judge Exhibit (hereinafter, ALJX) 1 (Order
                to Show Cause (hereinafter, OSC)), at 1. The OSC proposed the
                revocation of Respondent's DEA certificate of registration
                (hereinafter, registration) on the ground that he ``materially
                falsified . . . [his] application for renewal in violation of 21 U.S.C.
                823(f) and 824(a)(1).'' Id.
                 The substantive grounds for the proceeding, as more specifically
                alleged in the OSC, are that Respondent, ``[o]n or about February 7,
                2017, . . . submitted a renewal application for . . . [his registration
                number] BS5000411 seeking to change . . . [his] registered address to .
                . . Hammond, Indiana . . . [and] made two material false statements in
                . . . [his] renewal application''--(1) answering ``no'' to whether he
                had ever been convicted of a crime in connection with controlled
                substances under state or federal law, or whether any such action is
                pending, and (2) answering ``no'' to whether he had ever surrendered
                (for cause) or had a state professional license revoked, suspended,
                denied, restricted, or placed on probation, or whether any such action
                is pending. Id. at 2. Citing 21 U.S.C. 823(f) and 824(a)(1), the OSC
                concluded that ``DEA must revoke . . . [Respondent's registration]
                based upon . . . [his] material falsifications of . . . [his] renewal
                application.'' Id.
                 The OSC notified 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 2-3 (citing 21
                CFR 1301.43). Respondent timely requested a hearing by letter dated
                April 29, 2017. ALJX 2 (Request for Hearing).
                 The matter was placed on the docket of the Office of Administrative
                Law Judges and assigned to Chief Administrative Law Judge (hereinafter,
                ALJ) John J. Mulrooney, II. The parties initially agreed to eight
                stipulations.\1\
                [[Page 45230]]
                ALJX 11 (Prehearing Ruling, dated June 22, 2017), at 1-2.
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                 \1\ ``1. The Respondent is registered with the DEA as a
                practitioner to handle controlled substances in Schedules II to V
                under DEA COR [certificate of registration] No. BS5000411, with a
                registered address of Regional Health Center, 559 State Street,
                Hammond, Indiana 46320. The Respondent's DEA COR expires by its own
                terms on February 29, 2020.
                 ``2. From April 17, 2015 to May 11, 2015, the Respondent was
                incarcerated in Kentucky.
                 ``3. On February 5, 2016, the Respondent entered into a
                Voluntary Agreement Not to Practice Medicine in the Commonwealth of
                Massachusetts with the Board of Registration.
                 ``4. On January 26, 2017, the Respondent was indicted by the
                Commonwealth of Massachusetts for: (1) 26 counts of Improper
                Prescriptions, in violation of Mass. Gen. Laws ch. 94C Sec. 19(a);
                (2) 22 counts of False Health Care Claims, in violation of Mass.
                Gen. Laws ch. 175H Sec. 2; and (3) 20 counts of Uttering False
                Prescriptions, in violation of Mass. Gen. Laws ch. 94C Sec. 33(b).
                 ``5. On February 7, 2017, at approximately 17:04 Eastern Time,
                the Respondent submitted a renewal application for his DEA COR.
                 ``6. The Respondent did not disclose the February 5, 2016
                Voluntary Agreement Not to Practice Medicine on his February 7, 2017
                renewal application.
                 ``7. The Respondent did not disclose the January 26, 2017
                indictments outlined above on his February 7, 2017 renewal
                application.
                 ``8. The Respondent did not supplement his February 7, 2017
                renewal application.''
                 On the hearing day, the parties submitted additional
                Stipulations. ALJX 26; transcript page number (hereinafter, Tr.) 5-
                6. According to the ``Joint Notice of Stipulations,'' the parties
                stipulated to the authenticity of Respondent's registration in GX 1,
                of Respondent's registration history in GX 2, and of the Affidavit
                of Daniel Kelly, RX 3.
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                 The hearing in this matter lasted one day and took place in
                Arlington, Virginia on August 22, 2017. The Recommended Rulings,
                Findings of Fact, Conclusions of Law, and Decision of the
                Administrative Law Judge (hereinafter, RD) is dated September 29, 2017.
                Respondent filed exceptions to the RD. ALJX 31 (Respondent's Exceptions
                to the CALJ's Recommended Decision, dated Oct. 19, 2017). The
                Government sought and received leave to respond to Respondent's
                Exceptions over Respondent's objection. ALJX 32 (Government's Request
                for Leave to File Response to Respondent's Exceptions, dated Oct. 19,
                2017); ALJX 34 (Order Granting the Government's Request for Leave to
                File Response to Respondent's Exceptions, dated Oct. 24, 2017). The
                Government's response to Respondent's Exceptions is dated November 1,
                2017. ALJX 35 (Government's Response to Respondent's Exceptions, dated
                Nov. 1, 2017).
                 Having considered the record in its entirety, I agree with the RD's
                conclusion that the record establishes, by clear, unequivocal, and
                convincing evidence, that Respondent materially falsified his
                registration renewal application.\2\ I find that Respondent did not
                accept responsibility for the material falsification. Accordingly, I
                conclude that I can no longer entrust Respondent with a registration,
                that his registration should be revoked, and that any pending
                application by Respondent for registration in Indiana should be denied.
                I make the following findings.
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                 \2\ I reviewed, and agree with, the Chief ALJ's pre-hearing,
                hearing, and post-hearing rulings and orders.
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                II. Findings of Fact
                A. Respondent's Current Registration
                 Respondent's current registration, BS5000411, is at the Regional
                Health Center in Hammond, Indiana. GX 1 (Certificate of Registration),
                at 1; Tr. 13. Its expiration date is February 29, 2020.\3\ GX 1, at 1;
                GX 2 (Certification of Registration Status), at 1.
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                 \3\ The current status of Respondent's registration, whether
                expired or timely renewed, does not impact my adjudication of this
                matter. Jeffrey D. Olsen, M.D., 84 FR 68,474 (2019); 5 U.S.C.
                558(c).
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                B. The Investigation of Respondent
                 A former employee of Respondent contacted DEA stating that
                Respondent ``authorized the issuing of prescriptions and seeing
                patients by a medical assistant in his office while he was
                incarcerated.'' Tr. 20, 23. The case Diversion Investigator
                (hereinafter, DI) followed up on the allegation by obtaining copies of
                prescriptions that Respondent issued during his incarceration and
                requesting recordings of telephone conversations between Respondent and
                his office staff during the same period. Id. at 23-30.
                 While the hearing testimony's description of the allegation does
                not specify whether any of the alleged prescriptions were for
                controlled substances, there is substantial evidence in the record that
                the allegation did include, at least in part, the prescribing of
                controlled substances. For example, the DEA employee staffing the DEA
                tip line referred the allegation to DI. Id. at 20-23. If the allegation
                had no potential connection to controlled substances, the DEA employee
                initially receiving the tip would not have referred it to DI for
                investigation based on DEA's jurisdiction. Further, DI's investigation
                of the allegation included his request for information from
                prescription monitoring programs (hereinafter, PDMP). Id. at 23-24. The
                Massachusetts PDMP was established to ``maintain an electronic system
                to monitor the prescribing . . . of all schedule II to V, inclusive,
                controlled substances and certain additional drugs . . . determined . .
                . to carry a bona fide potential for abuse.'' Mass. Gen. Laws ch. 94C,
                Sec. 24A (Current through Chapter 44 of the 2020 2nd Annual Session).
                Had the tip not included an allegation related to controlled
                substances, there would not have been any reason for DI to request PDMP
                information. As such, I find that the allegation by Respondent's staff
                concerned, at least in part, the unlawful prescribing of controlled
                substances.
                C. The Material Falsification Allegations
                 As already discussed, the OSC alleges that Respondent submitted a
                renewal application containing two material falsifications. OSC, at 2.
                The first alleged material falsification is his negative response to
                whether he had ever been convicted of a crime in connection with
                controlled substances under state or federal law, or whether ``any such
                action [is] pending?'' Id. According to the Government, Respondent's
                negative response to this ``liability question'' was materially false,
                because the ``Commonwealth of Massachusetts had indicted . . . [him]
                for crimes in connection with controlled substances less than two weeks
                earlier.'' Id.
                 The second alleged material falsification is Respondent's negative
                response to whether he had ``ever surrendered (for cause) or had a
                state professional license . . . revoked, suspended, denied,
                restricted, or placed on probation, or is any such action pending?''
                Id. The OSC alleges, and the Government sufficiently and timely further
                explicated, that this negative response was materially false, because
                Respondent ``had just agreed to not practice medicine within the
                Commonwealth of Massachusetts.'' \4\ Id.; 5 U.S.C. 554(b)(3); contra
                ALJX 31, at 1.
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                 \4\ Although the date in the OSC associated with this allegation
                is February 5, 2017, the parties subsequently agreed that the
                correct date is February 5, 2016. Joint Stipulation No. 3.
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                 There is factual agreement among the witnesses on a number of
                matters. When there is factual disagreement, I apply my credibility
                determinations and the credibility recommendations of the Chief ALJ in
                all but a portion of one instance. Infra Section D.
                D. The Government's Case
                 The Government's admitted documentary evidence consists primarily
                of Respondent's renewal application (GX 6), the sixty-eight page
                Hampden County Superior Court criminal indictment of Respondent (GX 5),
                and the Voluntary Agreement Not to Practice Medicine that Respondent
                and his attorney signed and that the Massachusetts Board of
                Registration in Medicine (hereinafter, MBRM) ``accepted,'' on February
                5, 2016 (GX 3) (hereinafter, Mass. Accepted Voluntary No-Practice
                Agreement).\5\ The
                [[Page 45231]]
                Government called two witnesses: DI and an Investigator for the MBRM
                (hereinafter, MBRM Investigator).
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                 \5\ The Hampden County Superior Court criminal indictment
                charges Respondent with twenty-six counts of ``improper
                prescription,'' twenty counts of ``uttering false prescription,''
                and twenty-two counts of ``false health care claim.'' GX 5
                (Massachusetts Superior Court Indictment No. 17 039 (dated Jan. 26,
                2017)). The improper prescription allegations concern controlled
                substances such as hydrocodone (15 counts), oxycodone (6 counts),
                fentanyl (3 counts), and methadone (3 counts).
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                 DI testified about his investigation-related activities of the
                ``tip'' submitted by Respondent's former employee, including, his
                interaction with Respondent's attorney, Daniel M. Kelly, on February 6,
                2017, about the Hampden County Superior Court criminal indictment of
                Respondent and his request for the surrender of Respondent's
                registration, and his acquisition of an official copy of the Mass.
                Accepted Voluntary No-Practice Agreement (GX 3). Tr. 34-40 and 41-43,
                respectively.
                 DI testified during the Government's rebuttal case that he
                investigated whether DEA had a record of Respondent's notification of
                the Mass. Accepted Voluntary No-Practice Agreement. Tr. 140. DI stated
                that he checked DEA's ``permanent and running database of any activity
                regarding any registrants or any DEA registration.'' Id. at 142. He
                also testified that he asked the registration specialist for
                Massachusetts, who is responsible for recording any communication from
                a registrant, whether DEA had received a communication from Respondent.
                Id. at 143. Neither the check of the database nor the check with the
                registration specialist showed any communication from Respondent about
                the Mass. Accepted Voluntary No-Practice Agreement. Id. at 140-45. DI
                acknowledged that Respondent could have notified DEA after DI checked
                the database and spoke with the registration specialist, and that the
                registration specialist's check may not have been thorough. Id. at 146-
                48.
                 I agree with the Chief ALJ that DI's testimony was ``sufficiently
                detailed, internally consistent, and plausible to be granted full
                credibility'' and that he ``presented as a credible, objective,
                dispassionate investigator without any discernible incentive to
                fabricate or exaggerate.'' RD, at 5.
                 MBRM Investigator testified that he is the lead MBRM investigator
                assigned to assess the information the MBRM received from DEA about
                Respondent, that Respondent issued prescriptions when incarcerated in
                Kentucky, and that the investigation remains open. Tr. 59, 77. MBRM
                Investigator testified about the multiple oral and written
                communications he had with Respondent, Respondent's hiring an attorney,
                Respondent's signing the Mass. Accepted Voluntary No-Practice
                Agreement, and Respondent's continued lack of permission to practice
                medicine in Massachusetts due to his signing the Mass. Accepted
                Voluntary No-Practice Agreement.\6\ Tr. 59-75, 74, 74-75, and 75-80,
                respectively.
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                 \6\ During cross-examination, MBRM Investigator responded ``no''
                when Respondent's counsel asked if the Mass. Accepted Voluntary No-
                Practice Agreement is a suspension, revocation, resignation,
                lapsing, or restriction on Respondent's medical license, or if it is
                a ``probationary agreement.'' Tr. 77-78.
                 In response to questions posed by the Chief ALJ, MBRM
                Investigator stated his understanding that ``if you practice
                [medicine] during a voluntary, we as the Board of Medicine could
                possibly summarily suspend you.'' Tr. 80; see also GX 3, at 2.
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                 MBRM Investigator testified during the Government's rebuttal case
                that he previously investigated two other cases concerning Respondent.
                Id. at 150-52. In both instances, MBRM Investigator stated, he notified
                Respondent of the investigation by phone, by letter, or by both phone
                and letter. Id. at 152.
                 MBRM Investigator also testified during the Government's rebuttal
                case that Respondent ``would call and leave . . . messages'' about the
                case, ``continually . . . asking what he could do to speed the case
                along.'' Id. at 152-53. According to the MBRM Investigator,
                Respondent's calls occurred during the summer of 2016. Id. at 153.
                Respondent did not rebut this aspect of MBRM Investigator's testimony.
                Id. at 154.
                 I agree with the Chief ALJ that MBRM Investigator's testimony was
                ``sufficiently detailed, internally consistent, and plausible to be
                granted full credibility,'' except as to the plausibility of MBRM
                Investigator's interpretation of the legal effect of the Mass. Accepted
                Voluntary No-Practice Agreement. RD, at 5. I agree with the Chief ALJ
                that MBRM Investigator ``presented as a credible, objective,
                dispassionate investigator without any discernible incentive to
                fabricate or exaggerate.'' Id.
                E. Respondent's Case
                 Respondent testified and called no other witness. Tr. 81-82.
                 During his testimony, Respondent recounted his pursuit of a career
                as a physician since his childhood, discussed his medical licenses and
                primary care physician practices in Indiana and Massachusetts, and
                explained that the ``immediate cause'' of his moving from Massachusetts
                to Indiana was his ``enter[ing] into the voluntary agreement not to
                practice medicine'' on February 5, 2016. Id. at 86-87, 88-93, and 93-
                95, respectively.
                 Respondent testified that he first found out from MBRM Investigator
                that Massachusetts was investigating him on or about January 27, 2016,
                about a week after he submitted a medical license renewal application.
                Id. at 131. Respondent testified he entered into the Mass. Accepted
                Voluntary No-Practice Agreement because the MBRM ``had concerns
                regarding what occurred with . . . [his] divorce, incarceration,
                contempt,'' and because MBRM Investigator asked him to sign it. Id. at
                95-96. He testified that he signed it with the assistance of Mr. Kelly,
                ``the attorney who's representing . . . [him] in the indictment in
                Massachusetts,'' that his Massachusetts medical license had not
                expired, and that the Mass. Accepted Voluntary No-Practice Agreement
                ``is non-disciplinary, there's no violation, so I guess it's a tool
                that Massachusetts has or a remedy until they can further pursue . . .
                whatever they have concerns about.'' \7\ Id. at 96-97.
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                 \7\ Stipulation No. 2, ``From April 17, 2015 to May 11, 2015,
                the Respondent was incarcerated in Kentucky,'' concerns Respondent's
                having been held in contempt and incarcerated in Kentucky in
                connection with a divorce matter. ALJX 11, at 2. During cross-
                examination, Respondent admitted that he responded in the negative
                to a question on the Massachusetts medical license renewal
                application about whether he had been ``charged with any criminal
                offense during this period?'' Tr. 124-25. He also admitted to
                responding ``no'' to questions on the same application about whether
                any criminal offenses or charges against him had been resolved
                during the time period, and whether any criminal charges were
                pending against him ``today.'' Tr. 125-26. Respondent explained that
                he answered ``no'' because the Kentucky matter was about his divorce
                and not, in his understanding, about a medical or criminal matter.
                Tr. 129. He stated that ``to think that contempt in my divorce rose
                to a level of criminal activity, it didn't quite register like that.
                I mean, I'm sorry. It just didn't.'' Id.
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                 Respondent confirmed that there are ``reporting requirements''
                associated with the Mass. Accepted Voluntary No-Practice Agreement and
                certified that he fulfilled them. Id. at 97-98, 155-56. He testified
                that he received a ``return receipt requested'' green card from his
                notification to DEA, but no actual notification of receipt from DEA.
                Id. at 98-99.\8\ He also stated that he did not have a ``direct
                conversation'' with anyone at DEA about his entering into the Mass.
                Accepted Voluntary No-Practice Agreement. Id. at 99.
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                 \8\ According to Respondent, he ``possibly may,'' but does not
                ``believe'' that he still has the return receipt card from the
                mailing to DEA. Tr. 115.
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                 During cross-examination, Respondent offered his perspective of the
                Mass. Accepted Voluntary No-Practice Agreement. He testified that the
                ``effect'' of the document is ``self-contained in the words of the
                document itself.'' Id. at 110. He stated that, although he did not know
                whether Massachusetts was still investigating him, he ``assumed'' that
                its investigation
                [[Page 45232]]
                was still open, more likely than not. Id. In response to a question
                posed by the Chief ALJ, however, Respondent agreed that his signing the
                Mass. Accepted Voluntary No-Practice Agreement meant that everything
                was ``sort of'' held in the status quo. Id. at 134. He again
                ``assumed'' that the hold was so MBRM could finish its investigation.
                Id. at 135. As Respondent continued to say ``I don't know'' and ``I
                guess'' about the status of the MBRM investigation, the Chief ALJ
                sought clarification, asking, ``But your belief wasn't that you were
                just going to stop practicing medicine forever. Your belief was that
                until they sort this out, you were in this status?'' Id. Respondent
                answered, ``Until, right, right, that they would sort it.'' Id. at 135-
                36.
                 The Chief ALJ then asked Respondent ``who is Daniel Kelly? Where
                does he come into it?'' Id. at 136. Respondent replied that Mr. Kelly
                represented him in the federal and local criminal matters ``from the
                beginning . . . so he was aware of--he knew the entire situation, I
                guess,'' and that Respondent retained him ``a year prior'' to the
                indictment. Id. at 136-37. During this inquiry, the Chief ALJ
                suggested, and I agree, that Respondent retained a criminal defense
                attorney because he knew that a criminal investigation was pending. Id.
                 Respondent stated his understanding that the ``or is any such
                action pending'' portion of the third liability question did not call
                for him to answer yes, even though he assumed that Massachusetts was
                still investigating him. Id. at 111-12. When asked if he would have had
                to answer ``yes'' if he knew about an investigation by Massachusetts,
                he answered yes, he should have answered ``yes'' if he were aware of a
                Massachusetts investigation. Id. at 114-15. He elaborated by
                reiterating his view that the Mass. Accepted Voluntary No-Practice
                Agreement is a ``tool'' of the MBRM. Id. at 112. He stated that it is
                ``non-disciplinary'' and that it is ``not restriction, probation, all
                of the things that it has in there pertaining to the question, and my
                understanding is it's to avoid any action.'' Id. Further, on re-direct,
                Respondent testified that he ``answered the question [on the DEA
                application] honestly at that time . . . to the best of my knowledge.''
                Id. at 130. On re-cross, Respondent answered ``no'' when asked whether
                he thought ``putting all those ``No's'' there, it was more likely that
                they were going to renew your certificate of registration.'' Id. at
                133. He responded ``not one way or the other. I mean, they're asking
                questions and then they will make a determination based on the totality
                of everything. . . . [I]t's up to them.'' Id.
                 Regarding the Hampden County Superior Court criminal indictment,
                Respondent confirmed that its allegations stem ``from that time . . .
                [he] was incarcerated.'' Id. He testified that Mr. Kelly told him about
                the indictment on Thursday morning, February 9, 2017, a couple days
                after Respondent submitted the registration renewal. Id. at 100. He
                stated that he did not know that he had been indicted when he submitted
                the registration renewal. Id.; see also id. at 102-03 (denying he
                received personal service of the indictment before he submitted the
                renewal application).
                 Respondent testified that he never had a problem with his
                registration since he first received it in ``approximately'' 1996, and
                that he has had a ``full unrestricted'' medical license since 1996. Id.
                at 100-01. He stated that his registration and medical licenses have
                ``all been in good standing, unrestricted [in] full with all states
                that I've ever held licenses in.'' Id. at 101. Respondent explained his
                negative response to the third liability question on the renewal
                application by testifying that ``my license has not been revoked, my
                license has not been suspended. They did not deny my license. I have my
                license. It's currently preserved . . . . There's no restriction on my
                license. It has not been placed on probation. So the answer is no.''
                Id. at 104. In addition, Respondent confirmed that he did not
                ``consider whether the Massachusetts voluntary agreement not to
                practice medicine, whether that should cause . . . [him] to answer
                ``Yes'' to that particular question.'' Id.
                 Respondent testified that he ``honestly believed when . . . [he]
                completed the application that . . . [his] answers were truthful, to
                the best of . . . [his] ability,'' and that he had ``no intent to
                deceive the DEA. There would be no purpose in that.'' Id. at 104-05;
                see also id. at 109.\9\
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                 \9\ Respondent also testified that he would lose his job if he
                did not have a registration. Tr. 105.
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                 I agree with the Chief ALJ's analysis of the credibility of
                Respondent's testimony.
                 While the Respondent's testimony was not without some credible
                aspects, it was also not without some bases for reservation. In
                addition to the incontrovertible fact that as the subject of these
                proceedings, the Respondent has the most at stake, his unequivocal
                assertion that his state licensure has never been the subject of any
                investigation since the commencement of his medical practice in 1996
                was convincingly contradicted by . . . [MBRM Investigator], who
                credibly testified that he investigated the Respondent regarding a
                patient complaint and failure to cooperate with that complaint, and
                that he telephonically informed him about that investigation. . . .
                Further, . . . [Respondent's] unwillingness to acknowledge that
                benign responses to the Liability Questions were less likely to
                raise concern did not enhance his credibility here. The Respondent
                is an educated professional, and irrespective of his view that his
                answers in the application were candid, his refusal to accept the
                proposition that unremarkable responses are generally more likely to
                result in a favorable outcome in a DEA application was a gratuitous
                depreciation of his overall credibility.
                 Moreover, the Respondent's testimony that he forwarded a copy of
                the . . . [Mass. Accepted Voluntary No-Practice Agreement] to DEA,
                but failed to keep a shred of paperwork memorializing that act, is
                implausible. By the Respondent's own account, sending the Agreement
                to various offices, including DEA, was a term of the Agreement. . .
                . That he would fail to keep any evidence of his compliance with
                that term, particularly after he expounded on the importance of such
                compliance as an integral aspect of his profession, is simply not
                credible. Although much of the Respondent's testimony is worthy of
                belief, in instances where that testimony is at variance with other
                credible testimony, it must be viewed with heightened scrutiny.\10\
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                 \10\ The RD ``found that Respondent's testimony was
                `convincingly contradicted' by a Government witness, thus disputing
                the credibility of Respondent's testimony.'' ALJX 31, at 9.
                Respondent took exception to this portion of the RD, arguing that
                the RD's credibility determination ``is not supported by the cited
                record as Respondent never made any such assertion.'' Id. at 10. I
                reject Respondent's exception.
                 First, although Respondent correctly distinguishes between the
                words ``discipline'' and ``investigations'' in the transcript, he
                ignores the substance of MBRM Investigator's testimony. Tr. 101,
                151. MBRM Investigator clearly testified that he opened a ``second
                docket'' due to Respondent's ``failure to answer the . . . [MBRM]
                during that first case.'' Id. at 152. I find that Respondent's fully
                honest response to his counsel's question of ``And before all this
                started taking place, did you ever have any sort of medical state
                discipline?'' would have included and disclosed the opening of the
                second docket due to Respondent's failure to answer the MBRM during
                the first case. Id. at 101. Second, as the Government points out,
                Respondent inaccurately suggests that the RD makes a ``negative
                credibility determination based solely on Respondent's failure to
                disclose two prior state investigations.'' ALJX 35, at 8.
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                RD, at 7-8 [citations and footnotes omitted].
                F. Allegation That Respondent Submitted a Materially False Registration
                Renewal Application
                 As already discussed, the OSC charged Respondent with submitting a
                renewal application containing two material false statements. The first
                alleged material false statement concerns Liability Question No. 1 and
                Respondent's negative response as to whether he had ever been convicted
                of a crime in connection with controlled substances under state or
                federal law, ``or [is] any such action pending.'' OSC, at 2. The second
                alleged material false
                [[Page 45233]]
                statement concerns Liability Question No. 3 and Respondent's negative
                response as to whether he had ever surrendered (for cause) or had a
                state professional license revoked, suspended, denied, restricted, or
                placed on probation, or whether ``any such action [is] pending.'' Id.
                G. Liability Question No. 1
                 I find that Respondent answered ``no'' to the first Liability
                Question on the registration application. GX 2, at 2; ALJX 11, at 2
                (Stipulation Nos. 7 and 8). I find that the Hampden County Superior
                Court criminal indictment of Respondent is dated January 26, 2017. GX
                5. I find that DI informed Respondent's attorney about the Hampden
                County Superior Court criminal indictment on February 6, 2017. Tr. 34-
                40. Even if the Hampden County Superior Court criminal indictment is a
                precursor ``action pending'' to a possible criminal conviction in
                connection with controlled substances under state or federal law, I
                find that there is insufficient evidence in the record that Respondent,
                himself, as opposed to his attorney, knew about the Hampden County
                Superior Court criminal indictment on or before February 7, 2017. I,
                thus find that the evidence the Government submitted does not establish
                that Respondent's ``no'' response to the first Liability Question was
                false, let alone materially false, when he submitted his renewal
                application to DEA on February 7, 2017.
                H. Liability Question No. 3
                 I find from clear, unequivocal, and convincing evidence that
                Respondent answered ``no'' to the third Liability Question on the
                registration application. ALJX 11, at 2 (Stipulation Nos. 6 and 8); GX
                2, at 2. I find from clear, unequivocal, and convincing evidence that
                Respondent and his attorney signed the Mass. Accepted Voluntary No-
                Practice Agreement on February 5, 2016. GX 3, at 3. I find from clear,
                unequivocal, and convincing evidence that the MBRM ``accepted'' and
                ``ratified'' the Mass. Accepted Voluntary No-Practice Agreement on
                February 5, 2016 and February 11, 2016, respectively. Id.
                 I find from clear, unequivocal, and convincing evidence that the
                Mass. Accepted Voluntary No-Practice Agreement resulted from the MBRM
                investigation of the tip DEA received, that the Mass. Accepted
                Voluntary No-Practice Agreement is still in effect, and that the MBRM
                investigation was open at least through the date of the DEA
                administrative hearing. Tr. 76-77. I find from clear, unequivocal, and
                convincing evidence that the Mass. Accepted Voluntary No-Practice
                Agreement is the reason Respondent is not permitted to practice
                medicine in Massachusetts. ALJX 11, at 2 (Stipulation No. 3); Tr. 94-
                99. I find from clear, unequivocal, and convincing evidence that the
                terms of the Mass. Accepted Voluntary No-Practice Agreement include
                Respondent's ``immediate'' cessation of the practice of medicine in
                Massachusetts. GX 3, at 2. Based on clear, unequivocal, and convincing
                evidence, I find that the Mass. Accepted Voluntary No-Practice
                Agreement is a clear indicator, and is part, of pending action by the
                MBRM regarding Respondent's Massachusetts medical license. For example,
                the top of the first page of the Mass. Accepted Voluntary No-Practice
                Agreement is captioned ``In the Matter of'' Respondent and shows a
                docket number starting with the year. Id. The second paragraph clearly
                states that the Mass. Accepted Voluntary No-Practice Agreement ``will
                remain in effect'' until the MBRM modifies it, terminates it, ``takes
                other action against . . . [Respondent's] license to practice
                medicine,'' or ``takes final action on the above-referenced matter.''
                Id. The sixth paragraph of the Mass. Accepted Voluntary No-Practice
                Agreement warns that ``[a]ny violation of this Agreement shall be prima
                facie evidence for immediate summary suspension of my license to
                practice medicine.'' Id. [italics added]. The last page of the Mass.
                Accepted Voluntary No-Practice Agreement contains the dates on which
                the MBRM ``accepted'' and ``ratified,'' by vote of the MBRM, the
                Agreement. GX 3, at 3. These terms and provisions leave no room for
                doubt that the Mass. Accepted Voluntary No-Practice Agreement
                evidences, and is part of, pending action by the MBRM regarding
                Respondent's medical license. Indeed, I find from clear, unequivocal,
                and convincing evidence that the Mass. Accepted Voluntary No-Practice
                Agreement envisions the possibility that it could be used as prima
                facie evidence for the ``immediate summary suspension'' of Respondent's
                Massachusetts medical license. GX 3, at 2.
                 In sum, I find from clear, unequivocal, and convincing evidence
                that the third Liability Question on the application Respondent
                submitted to DEA asks whether the applicant ever surrendered (for
                cause) or had a state professional license or controlled substance
                registration revoked, suspended, denied, restricted, or placed on
                probation, ``or is any such action pending?'' \11\ GX 2, at 2. As
                already discussed, I find from clear, unequivocal, and convincing
                evidence that, at a minimum, the Mass. Accepted Voluntary No-Practice
                Agreement shows a pending action exists in Massachusetts concerning
                Respondent by its explicit warning that ``immediate summary
                suspension'' of Respondent's Massachusetts medical license is a
                possible result of ``any violation of this Agreement.'' \12\ GX 3, at
                2. Consequently, I find based on clear, unequivocal, and convincing
                evidence, that Respondent's ``no'' answer to the third Liability
                Question was false.\13\ For the same reasons, and based on the same
                clear, unequivocal, and convincing evidence, I also find that
                Respondent knew, or should have known, that his answer to the third
                Liability Question was false. Further, for the same reasons and based
                on the same evidence in conjunction with the credibility determinations
                I already made, I find that Respondent falsified his answer to the
                third Liability Question to help ensure DEA's favorable action on his
                application and, therefore, that Respondent's falsification indicates
                an intent to deceive.\14\
                ---------------------------------------------------------------------------
                 \11\ I need not address Respondent's argument that his signing
                the Mass. Accepted Voluntary No-Practice Agreement was not a ``for
                cause'' surrender because my Decision is not based on that aspect of
                Liability Question No. 3.
                 \12\ Respondent's argument that he is still subject to an open
                investigation may also be true. ALJX 30 (Respondent's Proposed
                Findings of Fact and Conclusions of Law, dated Sept. 21, 2017), at
                11. I need not address Respondent's argument that an investigation
                is not a ``pending action.'' Id. at 12-13. As already explained, the
                Mass. Accepted Voluntary No-Practice Agreement makes clear on its
                face that the MBRM has a pending action concerning Respondent, and I
                find unavailing all of Respondent's arguments to the contrary. See,
                e.g., ALJX 31, at 4-6.
                 \13\ For the same reasons, I conclude that Respondent's
                arguments that he ``still maintains his license,'' that he did not
                surrender it, are misplaced and legally irrelevant.
                 \14\ Proof of intent to deceive has never been, and is not, a
                required element of a material falsification under 21 U.S.C.
                824(a)(1). Indeed, at its essence, intent to deceive conflicts with
                Agency decisions' long-standing material falsification
                determinations of whether the applicant ``knew or should have
                known'' that the application was false. Some past Agency material
                falsification decisions address an intent to deceive in determining
                the appropriate sanction for a material falsification, as do I. See
                infra note 32.
                ---------------------------------------------------------------------------
                III. Discussion
                A. The Controlled Substances Act and the OSC Allegations
                 Pursuant to section 303(f) of the Controlled Substances Act
                (hereinafter, CSA), ``[t]he Attorney General shall register
                practitioners . . . to dispense . . . controlled substances . . . if
                the applicant is authorized to dispense . . .
                [[Page 45234]]
                controlled substances under the laws of the State in which he
                practices.'' 21 U.S.C. 823(f). Section 303(f) further provides that an
                application for a practitioner's registration may be denied upon a
                determination that ``the issuance of such registration . . . would be
                inconsistent with the public interest.'' Id. In making the public
                interest determination, the CSA requires me to consider the following
                factors:
                 (1) The recommendation of the appropriate State licensing board or
                professional disciplinary authority.
                 (2) The applicant's experience in dispensing . . . controlled
                substances.
                 (3) The applicant's conviction record under Federal or State laws
                relating to the manufacture, distribution, or dispensing of controlled
                substances.
                 (4) Compliance with applicable State, Federal, or local laws
                relating to controlled substances.
                 (5) Such other conduct which may threaten the public health and
                safety.
                Id.
                 ``These factors are . . . considered in the disjunctive.'' Robert
                A. Leslie, M.D., 68 FR 15,227, 15,230 (2003). I ``may rely on any one
                or a combination of factors and may give each factor the weight [I]
                deem[ ] appropriate in determining whether . . . an application for
                registration [should be] denied.'' Id. Moreover, while I am required to
                consider each of the factors, I ``need not make explicit findings as to
                each one,'' and I ``can `give each factor the weight . . . [I]
                determine[ ] is appropriate.' '' MacKay v. Drug Enf't Admin., 664 F.3d
                808, 816 (10th Cir. 2011) (quoting Volkman v. Drug Enf't Admin., 567
                F.3d 215, 222 (6th Cir. 2009) quoting Hoxie v. Drug Enf't Admin., 419
                F.3d 477, 482 (6th Cir. 2005)). In other words, the public interest
                determination ``is not a contest in which score is kept; the Agency is
                not required to mechanically count up the factors and determine how
                many favor the Government and how many favor the registrant. Rather, it
                is an inquiry which focuses on protecting the public interest; what
                matters is the seriousness of the registrant's misconduct.'' Peter A.
                Ahles, M.D., 71 FR 50,097, 50,098-99 (2006).
                 Pursuant to section 304(a)(1), the Attorney General is also
                authorized to suspend or revoke a registration ``upon a finding that
                the registrant . . . has materially falsified any application filed
                pursuant to or required by this subchapter.'' 21 U.S.C. 824(a)(1). It
                is well established that the various grounds for revocation or
                suspension of an existing registration that Congress enumerated in this
                section are also properly considered in deciding whether to grant or
                deny an application under section 303. See Richard J. Settles, D.O., 81
                FR 64,940, 64,945 (2016); Arthur H. Bell, D.O., 80 FR 50,035, 50,037
                (2015); The Lawsons, Inc., t/a The Medicine Shoppe Pharmacy, 72 FR
                74,334, 74,338 (2007); Samuel S. Jackson, D.D.S., 72 FR 23,848, 23,852
                (2007); Alan R. Schankman, M.D., 63 FR 45,260, 45,260 (1998); Kuen H.
                Chen, M.D., 58 FR 65,401, 65,402 (1993).\15\
                ---------------------------------------------------------------------------
                 \15\ Just as materially falsifying an application provides a
                basis for revoking an existing registration without proof of any
                other misconduct, see 21 U.S.C. 824(a)(1), it also provides an
                independent and adequate ground for denying an application. Richard
                J. Settles, D.O., 81 FR at 64,945; Arthur H. Bell, D.O., 80 FR at
                50,037; The Lawsons, Inc., t/a The Medicine Shoppe Pharmacy, 72 FR
                at 74,338; Bobby Watts, M.D., 58 FR 46,995, 46,995 (1993); Shannon
                L. Gallentine, D.P.M., 76 FR 45,864, 45,865 (2011).
                ---------------------------------------------------------------------------
                 The Government has the burden of proof in this proceeding. 21 CFR
                1301.44.
                 As already discussed, Respondent submitted a registration renewal
                application containing a false answer to the question of whether he
                ``ever surrendered (for cause) or had a state professional license . .
                . revoked, suspended, denied, restricted, or placed on probation, or is
                any such action pending?'' The Supreme Court explained decades ago that
                ``the ultimate finding of materiality turns on an interpretation of
                substantive law.'' Kungys v. United States, 485 U.S. 759, 772 (1988)
                (citing a Sixth Circuit case involving 18 U.S.C. 1001 and explaining
                that, even though the instant case concerned 8 U.S.C. 1451(a), ``we see
                no reason not to follow what has been done with the materiality
                requirement under other statutes dealing with misrepresentations to
                public officers''). The Supreme Court also clarified that a falsity is
                material if it is ``predictably capable of affecting, i.e., had a
                natural tendency to affect, the official decision.'' Id. at 771.
                 In this case, application of the Supreme Court's materiality
                analysis, in the context of the CSA, means that Respondent's false
                submission was material. Id. Indeed, the falsity Respondent submitted
                in his renewal application relates to three of section 303(f)'s five
                factors, which provide the bases for my determination of whether an
                application is inconsistent with the public interest. 21 U.S.C. 823(f);
                see JM Pharmacy Group, Inc., d/b/a Farmacia Nueva and Best Pharma
                Corp., 80 FR 28,667, 28,681 (2015) (stating that a falsity must be
                analyzed in the context of the application requirements sought by DEA
                and provided by the applicant, and must relate to a ground that could
                affect the decision); see also ALJX 30 (Respondent's Proposed Findings
                of Fact and Conclusions of Law, dated Sept. 21, 2017), at 14; Universal
                Health Servs., Inc. v. United States ex rel. Escobar, 136 S. Ct. 1989,
                2003 (2016) (hereinafter, Escobar) (stating that ``[u]nder any
                understanding of the concept, materiality `look[s] to the effect on the
                likely or actual behavior of the recipient of the alleged
                misrepresentation.'''); Maslenjak v. United States, 137 S. Ct. 1918,
                1928 (2017) (concluding that when ``there is an obvious causal link
                between the . . . lie and . . . [the] procurement of citizenship,'' the
                facts ``misrepresented are themselves disqualifying'' and I ``can make
                quick work of that inquiry''). Respondent's provision of false
                information deprived me of the ability to carry out my statutorily
                mandated five-factor analysis concerning the registration of
                practitioners. 21 U.S.C. 823(f). In other words, there is no doubt that
                Respondent's falsity was ``predictably capable of affecting, i.e., had
                a natural tendency to affect, the official decision'' the CSA instructs
                me to make. Kungys, 485 U.S. at 771.
                 The facts in this case clearly demonstrate the connection between
                one liability question and three of section 303(f)'s five factors.
                Infra note 30. The first section 303(f) factor is the ``recommendation
                of the appropriate State licensing board or professional disciplinary
                authority.'' 21 U.S.C. 823(f)(1). In this case, the MBRM accepted and
                ratified Respondent's Mass. Accepted Voluntary No-Practice Agreement on
                February 5 and 11, 2016, respectively. GX 3, at 2. As already
                discussed, pursuant to Respondent's Mass. Accepted Voluntary No-
                Practice Agreement, as accepted and ratified by the MBRM, Respondent
                admits that his Massachusetts medical license no longer permits him to
                practice medicine; Respondent's state professional license is
                restricted to a practical nullity. Tr. 89, 93. Further, as already
                discussed, the second paragraph of the Mass. Accepted Voluntary No-
                Practice Agreement explicitly states that the ``Matter'' of
                Respondent's Mass. Accepted Voluntary No-Practice Agreement, Docket No.
                16-033, remains pending before the MBRM. GX 3, at 2 (``This Agreement
                will remain in effect until the . . . [MBRM] determines that this . . .
                [Mass. Accepted Voluntary No-Practice Agreement] should be modified or
                terminated; or until the . . . [MBRM] takes other action against . . .
                [Respondent's] license to practice medicine; or until the . . . [MBRM]
                takes final action on the above-
                [[Page 45235]]
                referenced matter.''). In addition, also already discussed, a clear
                indication of the significance of the Mass. Accepted Voluntary No-
                Practice Agreement is the document's sixth paragraph that ``[a]ny
                violation . . . shall be prima facie evidence for immediate summary
                suspension'' of Respondent's medical license. Id. [italics added].
                Thus, Respondent's false submission implicates the first factor that I
                am statutorily mandated to consider. John O. Dimowo, M.D., 85 FR
                15,800, 15,809-10 (2020).
                 The second section 303(f) factor is the ``applicant's experience in
                dispensing . . . controlled substances.'' 21 U.S.C. 823(f)(2). I
                already found that DEA and Massachusetts law enforcement were
                investigating an allegation that Respondent unlawfully issued
                controlled substance prescriptions when he was incarcerated in
                Kentucky. Tr. 20-40. Further, the unrefuted record testimony is that
                Respondent entered into the Mass. Accepted Voluntary No-Practice
                Agreement after multiple interactions with the MBRM Investigator
                regarding this allegation. Id. at 93-97, 155-56; GX 5. The fact that
                this unrefuted record evidence includes unproven allegations does not
                change the salient point. The CSA requires me to consider Respondent's
                experience in dispensing controlled substances. Respondent's alleged
                controlled substance dispensing while incarcerated in Kentucky, which
                irrefutably led to the Mass. Accepted Voluntary No-Practice Agreement,
                implicates this CSA-mandated factor regardless of the weight, if any, I
                give it. The falsity Respondent submitted in his application deprived
                me of information potentially relevant to factor two, and, therefore, I
                was unable to carry out my CSA-mandated responsibilities.
                 The analysis of the same unrefuted record evidence under factor
                four (compliance with applicable state, federal, and local laws
                relating to controlled substances) leads to the same conclusion.
                Respondent's submission of a falsified application deprived me of
                information potentially relevant to factor four, and, therefore, I was
                unable to carry out my CSA-mandated responsibilities.
                 In sum, the falsity Respondent submitted relates to three of
                section 303(f)'s five factors. Based on an analysis of the CSA,
                Respondent's falsity directly implicates my statutorily mandated
                analysis and decision by depriving me of legally relevant facts.
                Escobar, 136 S. Ct. at 2002 (``Under any understanding of the concept,
                materiality `look[s] to the effect on the likely or actual behavior of
                the recipient of the alleged misrepresentation.'''). Consequently, I
                must find, based on the CSA and the analysis underlying multiple
                Supreme Court decisions involving materiality, that the falsity
                Respondent submitted was material.\16\
                ---------------------------------------------------------------------------
                 \16\ As the parties stipulated, Respondent's false submission to
                DEA appeared in the registration renewal application he submitted on
                February 7, 2017. ALJX 11, at 2 (Joint Stipulation No. 5), supra
                note 1. That renewal application was granted. Subsequently, DEA
                identified the falsity and issued the OSC seeking revocation based
                of 21 U.S.C. 824(a)(1).
                 The liability questions implicate the public interest factors
                of 21 U.S.C. 823(f). Infra note 30. A false response to a liability
                question is, by definition, therefore, always ``material'' and
                always a reason why I may deny an initial or subsequent application
                under section 303(f). According to the terms of section 303(f), my
                ultimate decision of whether to deny such a materially false
                application shall be based on my determination of whether ``issuance
                of such registration or modification would be consistent with the
                public interest'' as determined by my consideration of that
                section's five factors.
                 When, however, as here, the Agency does not identify the
                material falsity until after the registration or modification is
                granted, the determination of the appropriate sanction, if any, is
                based on the relevant facts and circumstances. 21 U.S.C. 824(a)(1).
                ---------------------------------------------------------------------------
                B. Respondent's Arguments and Exceptions
                 Respondent posited many arguments during the administrative hearing
                and in exceptions to the RD. Some have already been addressed. Others
                are addressed below.
                 Respondent argues that a recent Supreme Court decision's treatment
                of ``materiality'' in a False Claims Act case is ``particularly
                unfavorable to the Government's attempt to prove materiality in light
                of DEA's informed inaction.'' ALJX 30, at 16 (citing Escobar).
                According to Respondent, ``[i]n terms of . . . [False Claims Act]
                liability, the [Supreme] Court held that evidence that the government
                knew about an alleged regulatory violation that caused a claim
                submitted to the government to be false yet continued to pay those
                claims was `very strong evidence' that the underlying conduct was not
                material.'' Id. at 17. Since the Supreme Court ``utilized the same
                definition of `material' set forth by the [Supreme] Court in Kungys,''
                Respondent argues, the Government ``cannot prevail in light of its
                inaction despite knowledge of the alleged past conduct underlying the
                indictment.'' Id.
                 The RD rejects this argument, as do I. RD, at 16-17.
                 First, Respondent's reasoning, based on the appearance of the same
                root word, ``material,'' for applying Escobar's False Claims Act
                analysis to the CSA is not convincing. The Supreme Court in Escobar
                ties its analysis to ``other federal fraud statutes'' and to the common
                law.\17\ It connects its discussion of federal fraud statutes with the
                common law by stating that the ``common law could not have conceived of
                `fraud' without proof of materiality.'' Escobar, 136 S. Ct. at 2002
                (citing Neder v. United States, 527 U.S. 1, 22 (1999). It emphasizes
                the similarity of the definitions of ``materiality'' in the False
                Claims Act and in the common law by stating that ``[w]e need not
                decide'' whether the False Claims Act's ``materiality requirement is
                governed by . . . [the False Claims Act] or derived directly from the
                common law.'' Escobar, 136 S. Ct. at 2002. Thus, Respondent's
                invitation that I apply the Supreme Court's Escobar analysis of the
                False Claims Act to the CSA more broadly than only to the definition of
                ``materiality'' goes beyond the clear boundaries of Escobar and is
                without merit.\18\ As the RD states, ``Whether the
                [[Page 45236]]
                Government decides to pay a [contract] claim despite knowledge that
                certain conditions of payment are not satisfied simply does not
                implicate the same considerations as the decision of the Government to
                delay (or even to forgo) bringing . . . [a CSA] action against a . . .
                [registrant] despite knowledge of alleged conduct which could support a
                sanction.'' RD, at 16-17. I reject Respondent's invitation to equate
                the CSA with the False Claims Act. I agree with the RD that these two
                statutes share no commonality that would legally support, let alone
                require, such a correlation.
                ---------------------------------------------------------------------------
                 \17\ It explicitly mentions mail, bank, and wire fraud statutes,
                Neder v. United States, 527 U.S. 1 (1999), and fraudulent statements
                to immigration officials, Kungys v. United States, 485 U.S. 759
                (1988). Escobar, 136 S. Ct. at 2002.
                 \18\ Likewise, in conjunction with the Court's statement in
                Maslenjak, the Court's more recent naturalization decision, that the
                naturalization process ``is set up to provide little or no room for
                subjective preferences,'' I note that the CSA differs from the
                naturalization process in that respect. Maslenjak, 137 S. Ct. at
                1928 (concluding that ``the question of what any individual
                decisionmaker might have done with accurate information is beside
                the point'' because the ``entire system . . . is set up to provide
                little or no room for subjective preferences''). While the CSA
                establishes parameters for issuing and terminating registrations,
                the final registration-related decision, such as granting or denying
                a registration, and continuing, suspending, or revoking a
                registration, is left to the reviewable discretion of the Attorney
                General. 21 U.S.C. 823 and 824 (using the word ``may'' in provisions
                to confer discretion on the Attorney General regarding the granting,
                denying, continuing, suspending, and revoking of practitioner
                registrations). The difference between the objective naturalization
                process and the discretionary CSA process, however, does not detract
                from the usefulness of the Supreme Court's decisions on the meaning
                of ``materially falsified'' under section 304(a)(1).
                 Although the existence of a factor in 823(f) is not, in and of
                itself, disqualifying as a fact could be in the naturalization
                process, the CSA states clearly that ``in determining the public
                interest, the following factors shall be considered.'' 21 U.S.C.
                823(f) (emphasis added). Depriving me of accurate information that I
                am statutorily required to consider interferes with my
                responsibility to consider the public interest factors. The clear
                intent of the CSA is that applicants and registrants shall provide
                me with accurate information for my analysis under section 303, and
                that a falsification of any information concerning a section 303
                factor thwarts my ability to assess the public interest as the CSA
                requires me to do, and is therefore necessarily material to my
                decision on the application. In light of the discretion afforded me
                in the CSA, it would make little sense to impose a ``but for'' test
                or even a ``more likely than not'' test on the effect of a false
                statement. After all, I cannot analyze the five factors without
                accurate information.
                ---------------------------------------------------------------------------
                 Second, Respondent's argument takes Escobar beyond the parameters
                of the Supreme Court's opinion. Respondent argues that the Government
                ``cannot prevail in light of its inaction, despite knowledge of the
                alleged past conduct underlying the indictment.'' ALJX 30, at 17
                [emphasis added]. The Supreme Court, however, merely warned that ``if
                the Government pays a particular claim in full despite its actual
                knowledge that certain requirements were violated, that is very strong
                evidence that those requirements are not material.'' Escobar, 136 S.
                Ct. at 2003 [emphasis added]. Respondent's argument that the Government
                ``cannot prevail in light of its [prior] inaction'' against Respondent,
                is not only inapposite, it also carries the Escobar decision beyond the
                Court's clear terms that inaction is ``very strong evidence,'' but not
                dispositive.
                 Third, Respondent's argument incorrectly assumes that no crime or
                violation has occurred unless law enforcement has initiated a criminal
                prosecution or a civil or administrative enforcement action. According
                to Respondent, ``[i]f [Respondent's] alleged past conduct were
                material, DEA could have brought an order to show cause against . . .
                [him] based on this conduct at some point over the last two years.
                Instead, DEA has allowed . . . [Respondent] to maintain his COR.'' ALJX
                30, at 17. Respondent's position is untenable.
                 Section 304 of the CSA states that the Attorney General ``may''
                revoke or suspend a registration. 21 U.S.C. 824(a). The discretion the
                CSA affords the Attorney General regarding his initiation of a
                revocation or suspension enforcement action is unfettered.\19\
                According to the Supreme Court, in situations such as the one presented
                by the CSA, ``an agency's decision not to prosecute or enforce, whether
                through civil or criminal process, is a decision generally committed to
                an agency's absolute discretion.'' Heckler v. Chaney, 470 U.S. 821, 831
                (1985); see also 5 U.S.C. 701(a) and Heckler v. Chaney, 470 U.S. at
                831-32 (discussing reasons why there is generally no judicial review of
                agency decisions not to enforce).
                ---------------------------------------------------------------------------
                 \19\ Section 304(a)(1-5) lists grounds for suspension or
                revocation of a registration.
                ---------------------------------------------------------------------------
                 Fourth, Agency decisions have addressed section 304(a)(1),
                including the meaning of ``materially,'' on multiple past occasions.
                Relying on those interpretations of the CSA, as opposed to taking the
                novel approach that Respondent proposes, is important to the Agency's
                mission.\20\
                ---------------------------------------------------------------------------
                 \20\ To the extent that Agency decisions contain differences in
                their interpretations or applications of 21 U.S.C. 824(a)(1), I note
                F.C.C. v. Fox Television Stations, Inc., 556 U.S. 502 (2009). In
                that case, the Supreme Court acknowledged that administrative agency
                adjudications change course and addressed how an agency may do so
                and continue to pass muster on appellate review under the
                Administrative Procedure Act (hereinafter, APA). First, the Supreme
                Court pointed out that the APA does not mention a heightened
                standard of review for agency adjudication course adjustments. Id.
                at 514. Instead, it stated that the narrow and deferential standard
                of review of agency adjudications set out in 5 U.S.C. 706 continues
                to apply. Id. at 513-14 (concluding that ``our opinion in State Farm
                neither held nor implied that every agency action representing a
                policy change must be justified by reasons more substantial than
                those required to adopt a policy in the first instance.'').
                 Second, according to the Supreme Court, an agency would
                ``ordinarily display awareness that it is changing position'' and it
                may not ``depart from a prior policy sub silentio or simply
                disregard rules that are still on the books.'' Id. at 515. Further,
                an agency must ``show that there are good reasons for the new
                policy'' but need not ``demonstrate to a court's satisfaction that
                the reasons for the new policy are better than the reasons for the
                old one; it suffices that the new policy is permissible under the
                statute, that there are good reasons for it, and that the agency
                believes it to be better.'' Id. (emphases in original). Finally, the
                Supreme Court had warned in an earlier decision that an ``irrational
                departure'' from agency policy, ``as opposed to an avowed alteration
                of it,'' could be overturned as arbitrary and capricious, or an
                abuse of discretion. I.N.S. v. Yueh-Shaio Yang, 519 U.S. 26, 32
                (1996).
                 Thus, while my analysis of Agency decisions' legal
                interpretations over time of ``materially falsified'' shows
                substantial uniformity, I note a few instances of an arguable degree
                of departure. The departure may be attributable to particular or
                unusual facts, to my predecessor's perspective on the degree of
                transparency or candor required in the specific interaction with the
                Agency at issue, or the like. While my legal analysis of the CSA's
                provision addressing material falsification may not be the agency
                adjudication course adjustment the Supreme Court contemplated in Fox
                Television, I am following the Court's Fox Television parameters as
                I carry out my CSA-related responsibilities. The ramifications of my
                doing so include increasing transparency and facilitating any
                appellate review.
                ---------------------------------------------------------------------------
                 An Agency decision from 1986 noted that the Agency ``processes
                thousands of practitioner registrations each year'' and that there is
                ``no feasible method . . . [for the Agency] to make an investigation
                into the accuracy of each application submitted.'' William M. Knarr,
                D.O., 51 FR 2772, 2773 (1986) (noting that the falsifications were
                discovered by accident). This decision and others interpreting section
                304(a)(1) concluded that the submission of falsified applications is a
                serious offense that cannot be tolerated because it renders the Agency
                ``unable to meaningfully pass on the fitness of the applicant.'' Id.;
                see also Carl E. Darby, M.D., 53 FR 51,330, 51,331 (1988); Ronald H.
                Futch, M.D., 53 FR 38,990, 38,991 (1988). The questions on the
                registration application ``serve a purpose which cannot be overlooked
                by the Administrator'' and, had the applicant submitted accurate
                responses, ``an investigation could have taken place.'' Ezzat E. Majd
                Pour, M.D., 55 FR 47,547, 47,548 (1990) (finding finalized or pending
                medical license revocation/suspension proceedings in three states even
                though applicant provided a ``no'' answer to the relevant liability
                question on the application). In carrying out its statutory mission to
                authorize the dispensing of controlled substances in the public
                interest, the Agency must be able to rely on the truthfulness of
                applicants' submissions. Anne D. DeBlanco, M.D., 62 FR 36,844, 36,845
                (1997) (``Since DEA must rely on the truthfulness of information
                supplied by applicants in registering them to handle controlled
                substances, falsification cannot be tolerated.''); Leonel Tano, M.D.,
                62 FR 22,968, 22,972 (1997) (same); Linwood T. Townsend, D.D.S., 59 FR
                32,224, 32,225 (1994) (same); Bobby Watts, M.D., 58 FR 46,995, 46,995
                (1993) (same); Carl E. Darby, M.D., 53 FR at 51,331 (same); Ronald H.
                Futch, M.D., 53 FR at 38,991 (same); William M. Knarr, D.O., 51 FR at
                2773 (concluding that the Agency ``must rely on the truthfulness of
                every applicant'').
                 In the late 1990s, the Agency elaborated on its earlier decisions
                and distinguished between finding the existence of a material
                falsification and determining the appropriate sanction. Martha
                Hernandez, M.D. (hereinafter, Hernandez) repeated the observation from
                earlier Agency decisions that ``the Respondent knew, or should have
                known, that his DEA registration had been revoked.'' 62 FR 61,145,
                61,146 (1997) (citing Bobby Watts, M.D., 58 FR at 46,995 and Herbert J.
                Robinson, M.D., 59 FR 6304, 6304 (1994)). Hernandez, though,
                characterized this observation as a necessary part of the analysis of
                the existence of a material falsification. According to Hernandez,
                again referencing Bobby Watts, M.D. and Herbert J. Robinson, M.D.,
                ``DEA has previously held that in finding that there has been a
                material falsification of an application, it must be determined that
                the applicant knew or should have
                [[Page 45237]]
                known that the response given to the liability question was false.'' 62
                FR at 61,146. The Agency then ``conclude[d] that there is no question
                that . . . [respondent] materially falsified two of her applications
                for DEA registration'' and stated that this was ``extremely troubling
                since DEA relies on accurate information being submitted by its
                applicants.'' \21\ Id. at 61,148.
                ---------------------------------------------------------------------------
                 \21\ The falsifications in that case related to the doctor's
                inability to repay her student loan. The repayment issue had
                ramifications for her medical licenses in Illinois and Indiana. The
                Hernandez respondent admitted that her responses to the
                application's liability questions were incorrect. 62 FR at 61,146.
                ---------------------------------------------------------------------------
                 Admitting to the inaccuracy of the answers on her DEA application,
                the Hernandez respondent argued that she submitted no ``materially''
                false statement, that she had no intent to deceive or mislead DEA, that
                her underlying misconduct was not related to controlled substances, and
                that she responded correctly to similar questions on a state
                application after someone explained the proper way to interpret the
                application question. Id. at 61,146. The Agency did not fully embrace
                her arguments. In addition to concluding that the falsifications were
                material, Hernandez made clear that a misinterpretation of the
                application does ``not relieve [respondent] . . . of her responsibility
                to carefully read the question and to honestly answer all parts of the
                question.'' Id. at 61,147. While the decision may be interpreted to
                agree with the Hernandez respondent that she did not intend to deceive
                DEA, the decision states that ``negligence and carelessness in
                completing an application could be a sufficient reason to revoke a
                registration.'' Id. Regarding the Hernandez respondent's argument that
                the falsification did not involve controlled substances, the Agency
                agreed with the Government that it had ``in fact revoked registrations
                in the past based upon the material falsification of an application
                that was not related to the mishandling of controlled substances.'' Id.
                at 61,148 (citing Ezzat E. Majd Pour, M.D.).
                 Hernandez, then, drew the distinction between finding a material
                falsification and the next inquiry--whether ``revocation is the
                appropriate sanction in light of the facts and circumstances of this
                case.'' Id. The decision appears to credit as ``credible,'' while also
                stating it is ``clearly an incorrect interpretation,'' the Hernandez
                respondent's explanation for the falsity. Id. Further, the decision
                calls ``troubl[ing]'' the Hernandez respondent's ``carelessness in
                failing to carefully read the question on the applications.'' Id.
                Nevertheless, the decision finds ``significant'' that, prior to the
                issuance of the OSC, the Hernandez respondent ``answered a similar
                liability question correctly on her . . . Illinois application . . .
                after discussing the matter with an Illinois official.'' Id. The
                decision notes that the Illinois Department of Professional Regulation
                ``has seen fit to allow . . . [her] to continue to practice medicine as
                long as she continues to repay her loan.'' Id. Thus, the decision
                concludes, the state medical boards' handling of the Hernandez
                respondent's student loan repayment challenges was ``relevant, although
                not dispositive, in determining the appropriate sanction.'' Id. After
                considering all of the facts and circumstances, the decision concludes
                that ``revocation would be too severe a sanction given the facts and
                circumstances of this case.'' Id. at 61,148. Instead, it reprimands the
                Hernandez respondent ``for her failure to properly complete her
                applications for registration,'' and required her, for three years,
                ``to submit to the DEA . . . , on an annual basis, documentation from .
                . . [the] medical licensing authorities certifying that her medical
                licenses remain in good standing . . . and that there is no impediment
                to her handling controlled substances at the state level.'' Id.
                 Some Agency decisions incorporate both pre-Hernandez and Hernandez
                analyses.\22\ Other Agency decisions apply the material falsification
                elaborations and distinctions articulated in Hernandez, and continue
                developing the application of 21 U.S.C. 824(a)(1).\23\ For example, in
                2005, the Agency confirmed the ``knew or should have known''
                determination for whether there had been a ``material falsification''
                and the consideration of all the facts and circumstances in determining
                the appropriate sanction. Felix K. Prakasam, M.D., 70 FR 33,203,
                33,205-06 (2005). When faced with a respondent whose ``explanations for
                the misstatements and his continued insistence that his answers were
                correct are disingenuous at best,'' the Agency bluntly stated that
                respondent's answers were not accurate. Id. The Agency then stated
                clearly what it had introduced in a 1993 decision--its ``concern
                regarding Respondent's on-going refusal or inability to acknowledge a
                registrant's responsibility to provide forthright and complete
                information to DEA, when required to do so as a matter of law or
                regulation. This attitude . . . does not auger well for his future
                compliance with the responsibilities of a registrant.'' \24\ Id. Thus,
                the Agency revoked respondent's registrations based on a finding of a
                violation of 21 U.S.C. 824(a)(1) and respondent's lack of legally
                mandated forthrightness and transparency. Id.
                ---------------------------------------------------------------------------
                 \22\ See, e.g., VI Pharmacy, Rushdi Z. Salem, 69 FR 5584 (2004)
                (invoking the ``knew or should have known'' determination, stating
                that falsification cannot be tolerated since DEA must rely on the
                truthfulness of the information supplied by applicants in
                registering them, and evaluating the ``totality of the
                circumstances'' in determining the appropriate sanction); Thomas G.
                Easter II, M.D., 69 FR 5579 (2004) (citing Barry H. Brooks, M.D.
                concerning the ``knew or should have known'' determination,
                reiterating that answers to liability questions are always material
                because DEA relies on them to determine whether it is necessary to
                investigate the application, stating that falsification cannot be
                tolerated since DEA must rely on the truthfulness of the information
                supplied by applicants in registering them, and evaluating the
                ``totality of the circumstances'' in determining the appropriate
                sanction); Barry H. Brooks, M.D., 66 FR 18,305 (2001) (recounting
                testimony explaining how DEA uses the liability questions to
                evaluate applications, noting the ``knew or should have known''
                determination, rejecting the argument that the omission of relevant
                information from an application is not material if DEA already knows
                it, reiterating that answers to liability questions are always
                material because DEA relies on them to determine whether it is
                necessary to investigate the application, asserting that
                falsification cannot be tolerated, and evaluating the ``totality of
                the circumstances'' in determining the appropriate sanction).
                 \23\ See, e.g., Theodore Neujahr, D.V.M., 64 FR 72,362 (1999)
                (noting Hernandez and the ``knew or should have known'' test to
                determine materiality); KK Pharmacy, 64 FR 49,507 (1999) (same);
                Saihb S. Halil, M.D., 64 FR 33,319 (1999) (reiterating that the
                application signatory is responsible for the truthfulness of the
                application's contents, even if he did not personally complete it,
                and relying on the ``knew or should have known'' determination, no
                state authority, and admitted lack of knowledge of controlled
                substance regulations to revoke the registration); Anthony D.
                Funches, 64 FR 14,267 (1999) (finding a material falsification not
                based on intentional or negligent behavior, and granting the
                distributor registration subject to applicant's acceptance of
                inspection concessions); John J. Cienki, M.D., 63 FR 52,293 (1998)
                (reiterating that the applicant ``knew or should have known'' about
                the falsity of the response for a material falsification to exist);
                Samuel Arnold, D.D.S., 63 FR 8687 (1998) (stating that the applicant
                ``knew or should have known'' about the falsity of the response for
                there to be a material falsification, and that a consideration of
                all the facts and circumstances of the case determines the
                appropriate remedy when a material falsification exists); Richard S.
                Wagner, M.D., 63 FR 6771 (1998) (applying the ``knew or should have
                known'' determination, concluding that intent to deceive does not
                limit the sanction of revocation, and highlighting the extreme
                importance of truthful answers since they alert DEA as to whether
                further investigation is necessary).
                 \24\ In Kuen H. Chen, M.D., the Agency characterized, and
                adopted in its entirety, the Administrative Law Judge's
                recommendation. 58 FR 65,401 (1993). It did not attach the
                recommendation. The recommendation, as described in the Agency
                decision, found that respondent's ``cavalier attitude toward the
                importance of accurately executing the application suggests a lack
                of concern for the responsibilities inherent in a DEA
                registration.'' Id. at 65,402.
                ---------------------------------------------------------------------------
                 The Agency continued to develop the Felix K. Prakasam, M.D.
                forthrightness
                [[Page 45238]]
                and transparency analysis for 21 U.S.C. 824(a)(1) in Peter A. Ahles,
                M.D. According to that decision, ``it is clear'' and ``indisputable''
                that respondent materially falsified his application by not disclosing
                that California placed his medical license on probation three times. 71
                FR at 50,098. After finding that respondent materially falsified his
                application, the decision, citing the Sixth Circuit, stated that the
                Agency considers candor to be an ``important factor when assessing
                whether a physician's registration is consistent with the public
                interest'' and, therefore, ``falsification cannot be tolerated.'' Id.
                at 50,099 (citing Hoxie v. Drug Enf't Admin., 419 F.3d at 483).
                 My analysis shows that the approach to section 304(a)(1) taken by
                most past Agency decisions aligns with the instruction Kungys and its
                progeny provide concerning the meaning of ``material'' absent a
                definition in the relevant statute.\25\ As already discussed, the
                approach of Kungys and its progeny to materiality is consistent with
                the CSA.\26\ The Supreme Court's interpretation and analysis rest on
                the ``most common formulation . . . 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.'' 485 U.S. at 770. The
                Court emphasized that the test for materiality ``has never been'' 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.'' \27\ Id. at 771 [emphases in
                original]. According to the Court, the materiality test ``must be met,
                of course, by evidence that is clear, unequivocal, and convincing.''
                Id. at 772.
                ---------------------------------------------------------------------------
                 \25\ Indeed, in 2007, an Agency decision relied on Kungys for
                the meaning of ``material.'' Samuel S. Jackson, D.D.S., 72 FR 23,848
                (2007). In that Decision, the Agency determined that the
                Government's evidence was insufficient to establish a violation of
                21 U.S.C. 824(a)(1).
                 \26\ Regarding the different substantive legal contexts in which
                ``material'' appears, the Supreme Court stated that a statute
                revoking citizenship and a criminal statute whose penalties are a
                fine or imprisonment are not ``so different as to justify adoption
                of a different standard.'' Kungys, 485 U.S. at 770. According to the
                Court, ``[w]here Congress uses terms that have accumulated settled
                meaning under either equity or the common law, a court must infer,
                unless the statute otherwise dictates, that Congress means to
                incorporate the established meaning of these terms.'' Id. My review
                of Supreme Court cases citing Kungys shows that decision cited in a
                variety of cases, including the False Claims Act (Escobar, 136 S.
                Ct. 1989 (2016)), a false statement in conjunction with a firearm
                sale (Abramski v. United States, 573 U.S. 169 (2014)), mail and tax
                fraud (Neder v. United States, 527 U.S. 1 (1999)), and a false
                statement to federally insured financial institutions (United States
                v. Wells, 519 U.S. 482 (1997)). Thus, the Supreme Court instructs on
                the meaning of ``material'' in situations when ``material'' is not
                defined in the statute at issue.
                 \27\ Citing this portion of Kungys, some Agency decisions
                explicitly step away from pre-Kungys Agency decisions that found a
                false answer to a liability question ``always material'' due to
                DEA's reliance on the answers to those questions. See, e.g., Mark
                William Andrew Holder, M.D., 80 FR 71,618 n.19 (2015). I, however,
                see no inevitable conflict between these pre-Kungys Agency decisions
                and Kungys and its progeny.
                ---------------------------------------------------------------------------
                 Thus, following the Supreme Court, I conclude that the
                falsification of any of the liability questions is ``material'' under
                21 U.S.C. 824(a)(1). My conclusion flows directly from the fact that
                each of the liability questions is connected to at least one of section
                303(f) factors that, according to the CSA, I ``shall'' consider as I
                analyze whether issuing a registration ``would be inconsistent with the
                public interest.'' \28\ 21 U.S.C. 823(f). I am unable to discharge the
                responsibilities of the CSA every time I am given false information in
                response to a liability question. Thus, each falsification of a
                liability question has a natural tendency to influence, or is capable
                of influencing my decision and is therefore material.
                ---------------------------------------------------------------------------
                 \28\ The liability questions on the DEA-225 (04-12),
                ``Application for Registration,'' (Approved OMB NO 1117-0012, Form
                Expires: 9/30/2021) are (1) ``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?'' (see 21 U.S.C. 823(f)(2-4); see also Sec.
                824(a)(2) and (5)); (2) ``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?''
                (see 21 U.S.C. 823(f)(2-5); see also Sec. 824); (3) ``Has the
                applicant ever surrendered (for cause) or had a state professional
                license or controlled substance registration revoked, suspended,
                denied, restricted, or placed on probation, or is any such action
                pending?'' (see 21 U.S.C. 823(f)(1), (3), and (4); see also Sec.
                824(a)(3)); and (4) ``If the applicant is a corporation (other than
                a corporation whose stock is owned and traded by the public),
                association, partnership, or pharmacy, has any officer, partner,
                stockholder, or proprietor been convicted of a crime in connection
                with controlled substance(s) under state or federal law, or ever
                surrendered, for cause, or had a federal controlled substance
                registration revoked, suspended, restricted, denied, or ever had a
                state professional license or controlled substance registration
                revoked, suspended, denied, restricted or placed on probation, or is
                any such action pending?'' (see 21 U.S.C. 823(f)(1 through 5); see
                also Sec. Sec. 824 and 824(a)(2) and (3)) [emphases in original].
                ---------------------------------------------------------------------------
                 After finding the existence of a material falsification, I then
                determine the appropriate sanction. My determination involves
                considering all the facts and circumstances before me.
                 This Kungys/Maslenjak-based two-step analysis is consistent with
                the provisions of the CSA. It is consistent with the statutory
                requirements under section 303 (``the following factors shall be
                considered'' emphasis added), and the discretion afforded under section
                303(f) (``may deny an application'' emphasis added) regarding whether
                to deny a registration application or modification. In addition, my
                analysis and conclusion that this Respondent submitted a materially
                false renewal application are in line with the weight of past Agency
                decisions.\29\ Some of the
                [[Page 45239]]
                cases that Respondent urges me to follow are not.\30\
                ---------------------------------------------------------------------------
                 \29\ See, e.g., Zelideh I. Cordova-Velazco, M.D., 83 FR 62,902
                (2018) (citing both the ``knew or should have known'' determination
                and Kungys regarding material falsification allegations, and
                concluding that applicant's now-current state license is ``simply
                not relevant in terms of resolving'' the material falsification
                allegation); Richard Jay Blackburn, D.O., 82 FR 18,669 (2017)
                (citing Kungys and denying the application without a sanction
                analysis because the applicant had not opposed the Government's
                motion for summary disposition, let alone offered an explanation for
                the falsification or mitigating evidence); Wesley Pope, M.D., 82 FR
                14,944 (2017) (emphasizing an Agency decision that had applied the
                ``knew or should have known'' determination); Daniel A. Glick,
                D.D.S., 80 FR 74,800 (2015) (citing Kungys, stating that the
                ``correct analysis depends on whether the registrant knew or should
                have known that he or she submitted a false application,'' and
                considering the ``totality of the circumstances'' in determining the
                sanction); Mark William Andrew Holder, M.D., 80 FR 71,618 (2015)
                (finding a clear, intentional, and material falsification because
                applicant did not want DEA to discover that he was a drug abuser);
                Arthur H. Bell, D.O., 80 FR 50,035 (2015) (citing Kungys, concluding
                that applicant's failure to disclose his surrender of his DEA
                registration ``for cause'' was materially false and intentional, and
                finding that applicant failed to produce sufficient evidence showing
                why he should be entrusted with a new registration); JM Pharmacy
                Group, Inc., d/b/a Farmacia Nueva and Best Pharma Corp., 80 FR
                28,667 (2015) (citing both the ``knew or should have known''
                determination and Kungys regarding material falsification
                allegations, and concluding that applicant ``clearly knew'' that he
                ``(1) [h]ad surrendered his registrations, (2) had done so in
                response to allegations that his pharmacies had committed violations
                of the CSA, and (3) did so to avoid proceedings to revoke the
                registrations, [meaning] he also clearly knew that he had
                surrendered ``for cause''); Jose G. Zavaleta, M.D., 78 FR 27,431
                (2013) (citing both the ``knew or should have known'' determination
                and Kungys regarding material falsification allegations); Richard A.
                Herbert, M.D., 76 FR 53,942 (2011) (citing both the ``knew or should
                have known'' determination and Kungys regarding material
                falsification allegations, citing Hoxie about the importance of
                candor in the assessment of whether a registration is in the public
                interest, and explicitly tying the falsification to two 21 U.S.C.
                823(f) factors); Shannon L. Gallentine, D.P.M., 76 FR 45,864 (2011)
                (citing Kungys regarding material falsification allegations and
                explaining that ``[g]iven the circumstances of the surrender, during
                which . . . [applicant] was confronted with questions by the
                Investigators about his prescribing practices and lack of
                documentation to justify his prescriptions, . . . [applicant] cannot
                claim that he did not surrender his registration for cause''); Mark
                De La Lama, P.A., 76 FR 20,011 (2011) (citing Kungys regarding
                material falsification allegations); Gilbert Eugene Johnson, M.D.,
                75 FR 65,663 (2010) (finding that registrant knew his answers were
                false, citing Kungys, and stating that the false answers were
                material because the CSA requires consideration of the matters
                registrant falsified); Alvin Darby, M.D., 75 FR 26,993 (2010)
                (citing both ``knew or should have known'' and Kungys regarding
                material falsification allegations); Craig H. Bammer, D.O., 73 FR
                34,327 (2008) (citing Kungys on the meaning of a ``material'' false
                statement and Hoxie on ``candor''); The Lawsons, Inc., t/a The
                Medicine Shoppe Pharmacy, 72 FR 74,334 (2007) (citing both the
                ``knew or should have known'' determination and Kungys regarding
                material falsification allegations, and citing Hoxie about the
                importance of candor in the assessment of a registration
                application); but see Michel P. Toret, M.D., 82 FR 60,041 (2017)
                (ruling that a Voluntary Surrender Form alone, indicating nothing
                about applicant's failure to comply with any controlled substance
                requirement, is an insufficient basis to find a material
                falsification); Richard D. Vitalis, D.O., 79 FR 68,701 (2014)
                (citing Kungys, finding three ``clearly false, and knowingly so''
                answers regarding the suspension of his state medical license based
                on his history of alcohol dependency, and concluding that those
                false answers were not material because alcohol dependency is not
                actionable misconduct under the CSA); Hoi Y. Kam, M.D., 78 FR 62,694
                (2013) (citing Kungys, finding a false statement, stating that the
                ``relevant decision for assessing whether a false statement is
                material is the Agency's decision as to whether an applicant is
                entitled to be registered,'' and concluding the falsity was not
                material because the state license was no longer revoked and ``the
                Government offers no argument, let alone any evidence, that the
                truthful disclosure of the State's action against his medical
                license would have led it to evidence in the exclusion proceeding
                that Respondent violated any state rules or regulations regarding
                controlled substances and thus would have supported the denial of
                his application''); Scott C. Bickman, M.D., 76 FR 17,694, 17,701
                (2011) (citing both the ``knew or should have known'' determination
                and Kungys regarding material falsification allegations, citing
                Hoxie about the importance of candor in the assessment of a
                registration application and, citing Gonzales v. Oregon, granting
                the renewal application because the Government's evidence did not
                establish that ``Respondent's failure to disclose that the State
                Board had placed him on probation was capable of influencing the
                decision to grant his renewal application,'' because the probation
                was for medical malpractice and the CSA does not state that medical
                malpractice is a disqualification for a registration).
                 \30\ See, e.g., Respondent's citation to, and reliance on, the
                results in Hoi Y. Kam, M.D., 78 FR 62,694 (2013) and Scott C.
                Bickman, M.D., 76 FR 17,694, 17,701 (2011). ALJX 30, at 14.
                 Respondent also argues that ``the Government must prove that
                the overall intent of the application was to deceive DEA.'' ALJX 30,
                at 9 (citing Daniel A. Glick, D.D.S., 80 FR 74,800, 74,808 (2015)
                and Samuel S. Jackson, D.D.S., 72 FR 23,848, 23,852-53 (2007)).
                 According to Daniel A. Glick, D.D.S., 80 FR at 74,808, ``the
                correct analysis depends on whether the registrant knew or should
                have known that he or she submitted a false application,'' and
                ``[a]lthough even an unintentional falsification can serve as a
                basis for adverse action regarding a registration, lack of intent to
                deceive and evidence that the falsification was not intentional or
                negligent are all relevant considerations.'' Similarly, according to
                Samuel S. Jackson, D.D.S., 63 FR at 23,852, citing the ``knew or
                should have known'' determination, Agency decisions ``make clear
                that culpability short of intentional falsification is actionable.''
                 Thus, both Decisions Respondent cites, Daniel A. Glick, D.D.S.
                and Samuel S. Jackson, D.D.S., to support his argument state that a
                falsification need not be intentional to be actionable. I reject
                Respondent's argument that the Government must prove an ``overall
                intent to deceive DEA.'' An intent to deceive, however, has been
                considered as part of the totality of the circumstances when
                determining the appropriate sanction in the face of a material
                falsification. See, e.g., Daniel A. Glick, D.D.S., 80 FR at 74,808;
                Anthony D. Funches, 64 FR at 14,268-69.
                ---------------------------------------------------------------------------
                 In sum, I carefully considered all of Respondent's arguments and
                conclude, based on
                 clear, unequivocal, and convincing record evidence, that Respondent
                materially falsified his registration renewal application.
                IV. Sanction
                 Where, as here, the Government has established by clear,
                unequivocal, and convincing evidence that a respondent materially
                falsified his registration renewal application, the respondent must
                then ``present[ ] sufficient mitigating evidence'' to show why he can
                be entrusted with a registration. Garrett Howard Smith, M.D., 83 FR
                18,882, 18,910 (2018). Further, as past performance is the best
                predictor of future performance, Agency decisions require the
                respondent unequivocally to accept responsibility for his actions and
                demonstrate that he will not engage in future misconduct. ALRA Labs,
                Inc. v. Drug Enf't Admin., 54 F.3d 450, 452 (7th Cir. 1995); Jayam
                Krishna-Iyer, M.D., 74 FR 459, 463 (2009) (collecting cases); Jeffrey
                Stein, M.D., 84 FR 46,968, 46,972-73 (2019). In addition, a
                registrant's candor during the investigation and hearing has been an
                important factor in determining acceptance of responsibility and the
                appropriate sanction. Garrett Howard Smith, M.D., 83 FR at 18,910
                (collecting cases). The Agency has decided that the egregiousness and
                extent of the misconduct are significant factors in determining the
                appropriate sanction. Id. The Agency has also considered the need to
                deter similar acts by the respondent and by the community of
                registrants. Id. Consistent with past Agency decisions, I consider the
                totality of the facts and circumstances before me to determine the
                appropriate sanction. See, e.g., Hernandez, 62 FR at 61,147-48 (finding
                material falsification, but denying the Government's request for
                revocation as ``too severe'' given the facts and circumstances of the
                case).
                 Respondent's misconduct proven by the record evidence is one
                falsity on one application. However, the falsity was not the result of
                confusion or inadvertence, but a deliberate attempt to hide the
                existence of the Mass. Accepted Voluntary No-Practice Agreement. RD, at
                20. The record evidence regarding that falsity clearly demonstrates to
                me that Respondent does not take his responsibility of candor to the
                Agency seriously. Id. Accomplishing the scope of DEA's law enforcement
                responsibilities would be extraordinarily difficult if the Agency could
                not rely on the candor of applicants and those in the regulated
                community. Id.
                 I agree with the Chief ALJ that Respondent, through counsel,
                explicitly stated that Respondent did not accept responsibility and did
                not offer any remedial measures during his testimony.\31\ Id. at 18;
                Tr. 179. In his Posthearing Brief, Respondent reiterated that he does
                not prescribe controlled substances in his current position, yet needs
                a registration to continue to qualify for that position. ALJX 30, at
                23; Tr. 92, 105. The Posthearing Brief argues that revoking
                Respondent's registration would deprive the low-income and homeless
                patients he currently serves of his medical services.\32\ ALJX 30, at
                23. This argument is not consistent with recent Agency decisions
                concerning community impact evidence. I decline to accept Respondent's
                community impact argument.
                ---------------------------------------------------------------------------
                 \31\ Respondent's proposed Corrective Action Plan would have
                ``counsel review all registration applications [for the next five
                years] prior to submission to DEA to ensure accuracy and compliance
                with DEA's application disclosure requirements,'' and to take two,
                specified continuing medical education courses concerning opioids.
                 \32\ Respondent also argued that ``the sanction of revocation .
                . . would deviate from the Agency's decisions in Funches and
                Hernandez.'' ALJX 30, at 23. Both Funches and Hernandez, however,
                are inapposite.
                 In Funches, the application was for a registration as a retail
                distributor of list I chemicals. 64 FR at 14,267. The applicant
                indisputably operated his business in a ``responsible manner'' and
                credibly testified that the falsification was neither intentional
                nor negligent. Id. at 14,268. The falsification concerned a guilty
                plea twenty years before to a misdemeanor whose sentence was
                subsequently suspended, and ``involvement'' in a cocaine transaction
                over twenty years before. Id. at 14,267-69.
                 Hernandez, already discussed in detail, concerned a respondent's
                student loan repayment challenges and the state licensing
                authority's decision to allow the respondent to retain her medical
                license as long as she continued to repay her student loans. 62 FR
                at 61,147. The decision appeared to credit as ``credible,'' while
                also calling it ``clearly an erroneous interpretation,'' the
                respondent's explanation for the falsity. Id.
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                 As the Chief ALJ concluded, Respondent acknowledged no deficiency
                and offered no plan to conform his future conduct. RD, at 19. ``In his
                view,'' the RD observes, Respondent ``did nothing wrong and would
                presumably enter the same false response on a future renewal
                application if faced with like circumstances.'' Id. In this situation,
                revocation is appropriate to avoid another proceeding charging material
                falsification ``because the Respondent believes his conduct to have
                been appropriate.'' Id.
                [[Page 45240]]
                 I agree with the Chief ALJ that ``[c]onsiderations of specific and
                general deterrence militate in favor of revocation.'' Id. Failing to
                sanction Respondent in this case would send a message to Respondent and
                others in the registrant community that Respondent is vindicated, and
                that his false answer to Liability Question No. 3 is the ``benchmark of
                exactly how candid . . . [one] ever needs to be in providing
                information to DEA.'' Id. at 19-20. I decline to create a ``perverse
                incentive on registrants and applicants to withhold requested
                application information any time where the withheld information may
                lead to an adverse decision on a DEA registration or renewal
                application.'' Id. at 20.
                 I agree with the former Acting Assistant Administrator of the
                Diversion Control Division, that Respondent's proposed Corrective
                Action Plan provides no basis for me to discontinue or defer this
                proceeding. Its insufficiencies include Respondent's failure to accept
                responsibility, to institute remedial measures, and to convince me to
                entrust him with a registration. 21 U.S.C. 824(c)(3).
                 Accordingly, I shall order the sanctions the Government requested,
                as contained in the Order below.
                Order
                 Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21
                U.S.C. 824(a), I hereby revoke DEA Certificates of Registration
                BS5000411 issued to Frank Joseph Stirlacci, M.D. Pursuant to 28 CFR
                0.100(b) and the authority vested in me by 21 U.S.C. 823(f), I further
                hereby deny any pending application of Frank Joseph Stirlacci, M.D., to
                renew or modify this registration, as well as any other pending
                application of Frank Joseph Stirlacci, M.D. for registration in
                Indiana. This Order is effective August 26, 2020.
                Timothy J. Shea,
                Acting Administrator.
                [FR Doc. 2020-16193 Filed 7-24-20; 8:45 am]
                BILLING CODE 4410-09-P