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Federal Register / Vol. 86, No. 125 / Friday, July 2, 2021 / Notices
exercise of that discretion. 5 U.S.C.
557b 2006; River Forest Pharmacy, Inc. v. DEA, 501 F.2d 1202, 1206 7th Cir. 1974; Attorney Generals Manual on the Administrative Procedure Act 8
1947.

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Exclusion Under 42 U.S.C. 1320a7a The Government has alleged that the Respondent has been excluded from participation in a program pursuant to section 1320a7a of Title 42. The Government can meet its burden under 824a5 simply by advancing evidence that the registrant has been excluded from a federal health care program under 42 U.S.C. 1320a7a.
Johnnie Melvin Turner, M.D., 67 FR
71,203 2002; Dinorah Drug Store, Inc., 61 FR at 15,973. The Administrator has sanctioned registrants where the Government introduced evidence of a registrant/applicants plea agreement and judgment, and the resulting letter of exclusion from the U.S. Department of Health and Human Services, Office of Inspector General, imposing mandatory exclusion under section 1320a7a. See Richard Hauser, M.D., 83 FR 26,308
2018.
Additionally, the Agency has consistently held that the underlying conviction that led to mandatory exclusion does not need to involve controlled substances to support a revocation or denial. See, e.g., Mohammed Asgar, M.D., 83 FR 29,569
2018; Narciso A. Reyes, M.D., 83 FR
61,678 2018; Richard Hauser, M.D., 83
FR at 26,308; Orlando Ortega-Ortiz, M.D., 70 FR 15,122 2005; Juan PillotCostas, M.D., 69 FR 62,804 2004.
However, evidence that the underlying conviction does not relate to controlled substances can be used in mitigation.
Mohammed Asgar, M.D., 83 FR at 29,573 noting respondents conviction did not involve the misuse of his registration to handle controlled substances; Kwan Bo Jin, M.D., 77 FR
35,021, 35,027 2012 showing a lack of evidence concerning respondents prescribing practices. C
Governments Burden of Proof and Establishment of a Prima Facie Case Based upon my review of the allegation by the Government, it is necessary to determine if it has met its prima facie burden of proving the requirements for a sanction pursuant to 21 U.S.C. 824a.
It is clear from the stipulations, the Governments evidence, and the Respondents position in this matter that there is no controversy between the parties that the Respondent was C Language
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omitted for clarity.

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convicted of the underlying criminal charge in Virginia State court, and was subsequently mandatorily excluded from all federal health care programs by HHS/OIG, pursuant to 42 U.S.C. 1320a 7a. The Governments evidence clearly demonstrates the necessary elements of proof under 21 U.S.C. 824a5 and I
find that the Government has established a prima facie case for revocation of the Respondents COR and denial of any pending applications.
Therefore, the remaining issue, and the central focus for determination in this matter, is whether the Respondent has sufficiently demonstrated that he has accepted responsibility for his actions, has demonstrated remorse and taken sufficient rehabilitative and remedial steps, to demonstrate to the Acting Administrator that he can be entrusted to maintain his COR. Kwan Bo Jin, M.D., 77 FR at 35,021. The Agency must determine whether revocation is the appropriate sanction to protect the public from individuals who have misused controlled substances or their DEA Certificate of Registration and who have not presented sufficient mitigating evidence to assure the Administrative that they can be trusted with the responsibility carried by such a registration. Jeffrey Stein, M.D., 84 FR
46,968, 46,973 2019 quoting Leo R.
Miller, M.D., 53 FR 21,931, 21,932
1988. The Agency also looks to the nature of the crime in determining the likelihood of recidivism and the need for deterrence. Id. In determining whether and to what extent a sanction is appropriate, consideration must be given to both the egregiousness of the offenses established by the Governments evidence and the Agencys interest in both specific and general deterrence. David A. Ruben, M.D., 78 FR 38,363, 38,364, 38,385
2013. D
Acceptance of Responsibility and Rehabilitative Measures The Governments prima facie burden having been met, E the Respondent must present sufficient mitigating evidence to assure the Administrator that he can be entrusted with the responsibility incumbent with such registration. Medicine ShoppeJonesborough, 73 FR 364, 387 2008;
Samuel S. Jackson, 72 FR 23,848, 23,853
2007. F
The egregiousness and extent of an applicants misconduct are significant factors in determining the appropriate D Analysis of public interest factors omitted for relevance.
E Omitted text for clarity.
F Omitted additional public interest analysis.

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sanction. See Jacobo Dreszer, 76 FR
19,386, 19,38788 2011 explaining that a respondent can argue that even though the Government has made out a prima facie case, his conduct was not so egregious as to warrant revocation;
Paul H. Volkman, 73 FR 30,630, 30,644
2008; Gregory D. Owens, 74 FR 36,751, 36,757 n.22 2009.
Since the discovery of the overpayment, the Respondent has maintained a consistent posture of acknowledging the impropriety and illegality of his actions, and of cooperation with the Government in resolving the matter.G He has fully accepted responsibility for his conduct, which led to the underlying criminal conviction, both in his criminal prosecution, as well as in the instant proceeding. Tr. 58, 67; FoF 37. The Respondent testified credibly during the hearing when asked if he accepted responsibility for his misconduct:
Absolutely. If I could go back and fix it, I would. Tr. 58. When directly asked by Government counsel during crossexamination if he accepted responsibility, he stated, absolutely.
Id. at 67; FoF 37. The Respondent has further demonstrated remorse for his crime. Tr. 67; FoF 39.
Moreover, it is noted that Respondents crime did not directly benefit Respondent and appears to have been a mistake that Respondent was not aware was occurring. Even so, Respondent did not at any point attempt to shift the blame to anyone, he never tried to cover up his offense or lie, and he credibly maintained that even though his actions were unintentional and indirect, he was still fully responsible in his role as the Administrator for a mistake that happened under his watch.
Respondent credibly demonstrated remorse, and I find that he unequivocally accepted responsibility.
When asked how much restitution he G At the advice of his attorney, Respondent entered an Alford plea of guilty to the felony offense of false statement to Medicaid. Although entering this type of plea could be viewed as mitigating his actions, I do not find this to diminish Respondents acceptance of responsibility in this case. When asked if he had realized that the offense involved knowing or willful intent, Respondent replied that his attorney had handled the plea negotiation and had recommended that he view the Alford plea as a business decision. Tr. at 6869.
With regard to his Alford plea specifically, he stated, my interpretation of it was essentially that I did not personally go enter these claims, but I am responsible for it as the administrator. Id. at 50.
As such, I find that Respondent made it clear that he was following the legal advice that his lawyer had given him regarding a particular legal element of his offense and that his understanding was that he was still taking responsibility. Therefore, in spite of Respondents Alford plea, I find that he consistently and completely accepted responsibility.

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