[Federal Register Volume 86, Number 142 (Wednesday, July 28, 2021)]
[Notices]
[Pages 40636-40641]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-16004]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


William Ralph Kinkaid, M.D.; Decision and Order

    On November 7, 2018, the Assistant Administrator, Diversion Control 
Division, Drug Enforcement Administration (hereinafter, DEA or 
Government), issued an Order to Show Cause to William Ralph Kinkaid, 
M.D. (hereinafter, Respondent), of Johnson City, Tennessee. Order to 
Show Cause (hereinafter, OSC), at 1. The OSC proposed the denial of 
Respondent's application for DEA Certificate of Registration, Control 
No. W18085586C, because Respondent was ``mandatorily excluded . . . 
from participation in Medicare, Medicaid, and all Federal health care 
programs pursuant to 42 U.S.C. 1320a-7(a)'' and that such exclusion 
``warrants denial of [Respondent's] application pursuant to 21 U.S.C. 
824(a)(5).'' Id. at 1-2 (citing Richard Hauser, M.D., 83 FR 26,308 
(2018)).
    Specifically, the OSC alleged that, on June 24, 2013, the United 
States District Court for the Eastern District of Tennessee 
(hereinafter, E.D. Tenn.) issued a judgment against Respondent ``after 
[Respondent] pled guilty to one count of `Receiving in Interstate 
Commerce a Misbranded Drug with Intent to Defraud or Mislead,' in 
violation of 21 U.S.C. 331(c).'' Id. at 2 (citing U.S. v. William Ralph 
Kinkaid, No. 2:12-CR-116 (E.D. Tenn. June 24, 2013)). The OSC further 
alleged that ``based on [Respondent's] conviction, the U.S. Department 
of Health and Human Services, Office of Inspector General (``HHS/
OIG''), mandatorily excluded [Respondent] from participation in 
Medicare, Medicaid, and all Federal health care programs pursuant to 42 
U.S.C. 1320a-7(a)'' effective June 28, 2013, for a period of ten years. 
Id.
    The OSC notified Respondent of the right to request a hearing on 
the allegations or to submit a written statement, while waiving the 
right to a hearing, the procedures for electing each

[[Page 40637]]

option, and the consequences for failing to elect either option. Id. 
(citing 21 CFR 1301.43). The OSC also notified Respondent of the 
opportunity to submit a corrective action plan. Id. at 2-3 (citing 21 
U.S.C. 824(c)(2)(C)).
    Respondent submitted a Waiver of Hearing, Statement/Response to 
Order to Show Cause, and Corrective Action Plan dated December 5, 2018 
(hereinafter, Response to the OSC). Request for Final Agency Action 
Exhibit (hereinafter, RFAAX) 7. On January 10, 2019, DEA issued a 
letter to Respondent denying his proposed Corrective Action Plan. RFAAX 
8.
    The Government submitted a Request for Final Agency Action 
(hereinafter, RFAA), along with Respondent's Response to the OSC and 
the evidentiary record, for adjudication on May 30, 2019. I issue this 
Decision and Order based on the record submitted by the Government, 
which includes Respondent's Response to the OSC, and constitutes the 
entire record before me. 21 CFR 1301.43(e).

I. Findings of Fact

a. Respondent's Application for DEA Registration

    On August 6, 2018, Respondent submitted an application (Application 
Control No. W18085586C) for a DEA Certificate of Registration, at the 
proposed registered location of 193 Keefauver Road, Johnson City, TN 
37615 for a practitioner with drug schedules II-V. RFAAX 1 
(Certification of Registration Status). The application is in pending 
status. Id. Respondent previously held DEA Certificates of Registration 
Nos. BK2452819 and FK2770320, which are in retired status. Id.

b. Respondent's Criminal Conviction

    The evidence in the record demonstrates that, on June 24, 2013, 
judgment was entered against Respondent following a guilty plea in E.D. 
Tenn. based on one count of ``Receiving in Interstate Commerce a 
Misbranded Drug With Intent to Defraud or Mislead'' in violation of 21 
U.S.C. 331(c). RFAAX 4 (Judgment, U.S. v. William Ralph Kinkaid, No. 
2:12-CR-116 (E.D. Tenn. June 24, 2013)). In Respondent's guilty plea, 
he stipulated to a number of facts, which satisfied the offense 
elements. RFAAX 3 (Plea Agreement, U.S. v. William Ralph Kinkaid, No. 
2:12-CR-116 (E.D. Tenn. June 24, 2013)). In summary, Respondent 
admitted that he was majority owner and managing partner of McLeod 
Cancer and Blood Center in Johnson City, Tennessee (hereinafter, McLeod 
Cancer). Id. at 2. McLeod Cancer bought misbranded, unapproved 
prescription drugs, which were prescribed by Respondent and other 
doctors and administered to patients at McLeod Cancer from 
approximately September 2007 to early 2008 and from August 2009 to 
February 2012. Id. at 2, 5. The drugs were from foreign sources that 
were not inspected and approved by the U.S. Food and Drug 
Administration for distribution or use in the United States. Id. at 2-
5. McLeod Cancer sought reimbursement for the drugs and their 
administration from Medicare, Medicaid, and other health benefit 
programs. Id. at 2. After nurses at McLeod Cancer raised concerns that 
the drugs were not approved for use in the United States, McLeod Cancer 
briefly stopped purchasing the drugs. Id. at 5-6. When McLeod Cancer 
resumed purchasing the unapproved drugs, they had the drugs shipped to 
a storage business that Respondent owned to prevent the nurses from 
learning McLeod Cancer was again purchasing unapproved foreign drugs. 
Id. at 6.
    As a result of his conviction, Respondent was sentenced to 24 
months in federal detention, followed by a year of supervised release. 
RFAAX 4, at 2-3. He was also fined $10,000 and assessed $100 in costs. 
Id. at 4.

c. Respondent's Exclusion

    In June 2013, Respondent entered into a Settlement Agreement with 
the United States of America, in which he agreed ``to be excluded under 
[42 U.S.C. 1320a-7(a)(1) and 42 U.S.C. 1320a-7(b)(7)] from Medicare, 
Medicaid, and all Federal health care programs, as defined in 42 U.S.C. 
1320a-7b(f), for a period of ten (10) years.'' RFAAX 5 (Settlement 
Agreement), at 7. Respondent also agreed to pay $2,550,000 to the 
United States and to the State of Tennessee in damages and penalties. 
Id. at 3.

d. Respondent's State Medical License

    On July 22, 2015, the Tennessee Department of Health held a hearing 
regarding Respondent's state medical license. Response to the OSC, Ex. 
10 (Deliberations and Decision of the Panel, State of Tennessee Board 
of Medical Examiners v. William Kincaid, M.D.). At the hearing, the 
panel voted to revoke Respondent's license. Id. In the transcript from 
the hearing, the two panelists who voted to revoke Respondent's license 
explained that they were voting for revocation because Respondent had 
knowingly violated the law, id. at 4, 8, 13; had placed business 
interests ahead of his responsibilities to his patients, id. at 5-6; 
and the discipline ``should reflect the severity of what he did,'' id. 
at 14. The panel, however, did not vote for a permanent revocation. One 
of the panelists explained her vote for non-permanent revocation this 
way, ``I believe that the doctor is a good doctor who should be 
rehabilitated, but it's up to him to rehabilitate himself for at least 
a year and come back.'' Id. at 13.
    Respondent reapplied for a state medical license, and the State of 
Tennessee decided to grant him a limited medical license under a 
preceptorship on October 4, 2017. Response to the OSC, Ex. 12 (Oct. 4, 
2017 Letter from Tennessee Board of Medical Examiners). The State of 
Tennessee subsequently granted Respondent a medical license on July 24, 
2018. Response to the OSC, Ex. 13 (Respondent's Medical License).

II. Discussion

a. The Parties' Positions

i. Government's Position
    The OSC's sole allegation is that Respondent's exclusion from all 
federal health care programs pursuant to 42 U.S.C. 1320a-7(a) warrants 
denying his application under 21 U.S.C. 824(a)(5). OSC, at 2. The 
Government alleges that Respondent's exclusion was based on his guilty 
plea to one count of ``Receiving in Interstate Commerce a Misbranded 
Drug With Intent to Defraud or Mislead'' in violation of 21 U.S.C. 
331(c). RFAA, at 1. The Government further alleges that Respondent's 
exclusion from Medicare, Medicaid, and all Federal health care programs 
warrants denial of his application notwithstanding the fact that the 
underlying conduct that led to his exclusion did not have a nexus to 
controlled substances. OSC, at 2.
    The Government argues that 21 U.S.C. 824(a)(5) should be read ``as 
requiring revocation (or denial) of a respondent's DEA certificate of 
registration (or application), upon an adequate showing of the factual 
predicate, at least for the duration of the mandatory exclusion.'' 
RFAA, at 4. Accordingly, the Government has presented evidence that 
Respondent is excluded from participation in Federal health care 
programs pursuant to 42 U.S.C. 1320a-7(a) but has not presented any 
additional evidence or arguments regarding why Respondent's application 
for registration should be denied.
ii. Respondent's Position
    Respondent filed a written statement in response to the 
Government's OSC. Respondent's Response to the OSC included a number of 
exhibits with

[[Page 40638]]

documentary evidence to support his arguments, a first-person statement 
written from Respondent to the Tennessee Board of Medical Examiners, 
and dozens of letters that members of Respondent's community wrote on 
Respondent's behalf to the judge in Respondent's criminal case prior to 
sentencing. Respondent does not contest the Government's allegation 
that he is excluded from Federal health care programs pursuant to 42 
U.S.C. 1320a-7(a). Respondent acknowledges that on June 24, 2013, he 
was convicted of receiving in interstate commerce a misbranded drug in 
violation of 21 U.S.C. 331(c) and that as a result of that conviction, 
he was ``mandatorily excluded from all Federal healthcare programs by 
HHS/OIG for ten years from the date of conviction.'' Response to the 
OSC, at 1. Respondent argues, however, that DEA should grant his 
application for a controlled substances registration in spite of his 
exclusion.
    Respondent's Response to the OSC outlines his education and 
employment history, provides ``background'' information on his criminal 
offense, and discusses the loss of his state medical license and his 
re-licensure.\1\ In his first-person statement, Respondent briefly 
described how he came to be the senior partner and business manager for 
his clinic, McLeod Cancer. Respondent stated that he was ``ill-equipped 
as the business manager'' and that when the clinic hired a business 
manager, he thought ``[his] management problems were over.'' Response 
to the OSC, Ex. 1. Respondent then stated, however, ``[l]ittle did I 
know I was sowing the seeds of my own destruction. I let [the business 
manager] do as he pleased, not realizing the full extent of the 
consequences and the depth of his treachery.'' Id.
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    \1\ Respondent also included descriptions of the Department of 
Justice's conduct during its investigation and prosecution of his 
criminal case and dedicated a full page of his seven-page Response 
to the OSC (and attached dozens of pages of exhibits) to a criminal 
case that is unrelated, but Respondent states is factually similar, 
to Respondent's criminal case. Respondent presented documentation 
that, in this unrelated case, the Department of Justice moved to 
dismiss the case with prejudice when the defendants appealed their 
conviction. See Response to the OSC, at 3-5; Ex. 9 (Motion to Vacate 
Judgments of Conviction and Remand for Dismissal of Indictment with 
Prejudice, United States of America v. Patricia Posey Sen and 
Anindya Kumar Sen, Nos. 14-5786 (6th Cir. December 15, 2014). I am 
not addressing these portions of Respondent's Response to the OSC 
because this is not the proper forum to appeal Respondent's criminal 
conviction or to address any grievances Respondent may have 
regarding actions taken by the Department of Justice in relation to 
Respondent's criminal case.
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    Respondent states that after hiring the business manager, McLeod 
Cancer decided to purchase drugs from a particular supplier because 
they were ``cost-effective,'' but stopped because ``of concerns about 
applicable FDA regulations and laws.'' Response to the OSC, at 3. The 
McLeod Cancer physicians and business manager then sought a legal 
opinion from a private attorney ``on whether purchasing drugs from 
Canada for use in the United States was illegal.'' Id. Respondent 
submitted the attorney's response to the record as an exhibit to his 
Response to the OSC. Id. at Ex. 3. After receiving the attorney's 
opinion, Respondent decided to resume purchasing drugs from the 
supplier. Id. at Ex. 4, at 3. Respondent states that he ``interpreted 
the opinion paper as approving the practice,'' but now admits ``he was 
wrong and did not understand the possible significance of a `technical 
violation' and resulting consequences.'' Id.

b. Analysis of Respondent's Application for Registration

    In this matter, the OSC calls for my adjudication of the 
application for registration based on the charge that Respondent was 
excluded from participation in a program pursuant to section 1320a-7(a) 
of Title 42, which is a basis for revocation or suspension under 21 
U.S.C. 824(a)(2). OSC, at 1-2. The OSC does not allege that granting 
Respondent's application would be inconsistent with the public interest 
based on consideration of the factors in 21 U.S.C. 823(f)(1) through 
(5) (hereinafter, the public interest factors).
    Prior Agency decisions have addressed whether it is appropriate to 
consider a provision of 21 U.S.C. 824(a) when determining whether or 
not to grant a practitioner registration application. For over forty-
five years, Agency decisions have concluded that it is. Robert Wayne 
Locklear, M.D., 86 FR 33,738, 33,744-45 (2021) (collecting cases). In 
the recent decision Robert Wayne Locklear, M.D., the former Acting 
Administrator stated his agreement with the results of these past 
decisions and reaffirmed that a provision of section 824 may be the 
basis for the denial of a practitioner registration application. 86 FR 
at 33,745. He also clarified that allegations related to section 823 
remain relevant to the adjudication of a practitioner registration 
application when a provision of section 824 is involved. Id.
    Accordingly, when considering an application for a registration, I 
will consider any allegations related to the grounds for denial of an 
application under 823 and will also consider any allegations that the 
applicant meets one of the five grounds for revocation or suspension of 
a registration under section 824. Id. See also Dinorah Drug Store, 
Inc., 61 FR 15,972, 15,973-74 (1996).
i. 21 U.S.C. 823(f): The Five Public Interest Factors
    Pursuant to section 303(f) of the CSA, ``[t]he Attorney General 
shall register practitioners . . . to dispense . . . controlled 
substances . . . if the applicant is authorized to dispense . . . 
controlled substances under the laws of the State in which he 
practices.'' 21 U.S.C. 823(f). 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 consideration of the following 
factors:

    (1) The recommendation of the appropriate State licensing board 
or professional disciplinary authority.
    (2) The applicant's experience in dispensing, or conducting 
research with respect to 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.

21 U.S.C. 823(f).

    In this case, it is undisputed that Respondent holds a valid state 
medical license and is authorized to dispense controlled substances in 
the State of Tennessee where he practices. Response to the OSC, Ex. 12, 
13. The Government did not allege that Respondent's registration would 
be inconsistent with the public interest pursuant to section 823 in the 
OSC and did not advance any arguments or present any evidence under the 
public interest factors in its RFAA. See RFAA; RFAAX 2. Instead, the 
Government based its case in section 824 alleging that Respondent's 
conviction of receiving a misbranded drug with intent to defraud or 
mislead and his subsequent exclusion from federal health care programs 
by the U.S. Department of Health and Human Services merit the denial of 
his registration under 21 U.S.C. 824(a)(5). RFAA, at 1-4. Because the 
Government has not alleged that Respondent's registration is 
inconsistent with the public interest under section 823, I will not 
deny Respondent's application based on section 823, and although I have 
considered 823, I will not analyze Respondent's application under the

[[Page 40639]]

public interest factors. Therefore, in accordance with prior agency 
decisions, I will move to assess whether the Government has proven by 
substantial evidence that a ground for revocation exists under 21 
U.S.C. 824(a). Supra II.b.
ii. 21 U.S.C. 824(a)(5): Mandatory Exclusion From Federal Health Care 
Programs Pursuant to 42 U.S.C. 1320a-7(a)
    Under Section 824(a) of the Controlled Substances Act (hereinafter, 
CSA), a registration ``may be suspended or revoked'' upon a finding of 
one or more of five grounds. 21 U.S.C. 824. The ground in 21 U.S.C. 
824(a)(5) requires that the registrant ``has been excluded (or directed 
to be excluded) from participation in a program pursuant to section 
1320a-7(a) of Title 42.'' Id. Here, there is no dispute in the record 
that Registrant is mandatorily excluded from federal health care 
programs under 42 U.S.C. 1320a-7(a). The Government has presented 
substantial evidence of Respondent's exclusion and the underlying 
criminal conviction that led to that exclusion, and Respondent has 
admitted to the same. RFAAX 4, 5; Response to the OSC, at 1. I will, 
therefore, sustain the Government's allegation that Respondent has been 
excluded from participation in a program pursuant to section 1320a-7(a) 
of Title 42 and find that the Government has established that a ground 
exists upon which a registration could be revoked pursuant to 21 U.S.C. 
824(a)(5).\2\
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    \2\ The Government correctly argues, and Respondent did not 
rebut, that the underlying conviction forming the basis for a 
registrant's mandatory exclusion from participation in federal 
health care programs need not involve controlled substances to 
provide the grounds for revocation or denial pursuant to section 
824(a)(5). Jeffrey Stein, M.D., 84 FR 46,968, 46,971-72 (2019); see 
also Narciso Reyes, M.D., 83 FR 61,678, 61,681 (2018); KK Pharmacy, 
64 FR 49,507, 49,510 (1999) (collecting cases); Melvin N. Seglin, 
M.D., 63 FR 70,431, 70,433 (1998); Stanley Dubin, D.D.S., 61 FR 
60,727, 60,728 (1996).
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    Although the language of 21 U.S.C. 824(a)(5) discusses suspension 
and revocation of a registration, for the reasons discussed above, it 
may also serve as the basis for the denial of a DEA registration 
application. Robert Wayne Locklear, M.D., 86 FR at 33,745-46; Dinorah 
Drug Store, Inc., 61 FR at 15,973 (interpreting 21 U.S.C. 824(a)(5) to 
serve as a basis for the denial of a registration because it ``makes 
little sense . . . to grant the application for registration, only to 
possibly turn around and propose to revoke or suspend that registration 
based on the registrant's exclusion from a Medicare program''). 
Accordingly, Respondent's exclusion from participation in a program 
under 42 U.S.C. 1320a-7(a) serves as an independent basis for denying 
his application for DEA registration. 21 U.S.C. 824(a)(5).

III. Sanction

    The Government can meet its burden in a case involving a registrant 
who has been excluded from federal health care programs simply by 
showing evidence of the exclusion and the underlying conviction. 
Further, DEA has long held that the underlying conviction forming the 
basis of a registrant's mandatory exclusion from participation in 
Federal health care programs need not involve controlled substances for 
DEA to issue a sanction pursuant to 21 U.S.C. 824(a)(5). Jeffrey Stein, 
M.D., 84 FR 46,968, 46,971-71 (2019); Richard Hauser, M.D., 83 FR at 
26,310.
    The Government argues that in cases brought pursuant to 21 U.S.C. 
824(a)(5), the statutory language requires DEA to revoke a respondent's 
registration (or deny a respondent's application) once the Government 
has proven that a respondent is mandatorily excluded from participation 
in Federal health care programs and that DEA should not permit a 
respondent to have a DEA registration for as long as the respondent is 
excluded. RFAA, at 4. Since the Government filed the RFAA, however, the 
Agency issued a Decision and Order in another exclusion case, in which 
the Government made the same argument, Jeffrey Stein, M.D., that 
directly addressed and rejected the Government's argument. 84 FR 46,968 
(2019); see also Kansky J. Delisma, M.D., 85 FR 23,845 (2020).
    The clear language of 21 U.S.C. 824(a)--``[a] registration . . . 
may be suspended or revoked by the Attorney General''--gives the 
Administrator the discretion to revoke the registration of a registrant 
who has been excluded from participation in Federal health programs. 
Jeffrey Stein, M.D., 84 FR at 46,970-71 (providing detailed analysis of 
the language and legislative history of 21 U.S.C. 824(a)(5)). It does 
not require automatic revocation or denial on that ground. Id. 
Accordingly, although section 824(a) provides DEA with the authority to 
revoke a respondent's registration (or deny an application) upon a 
finding of one or more of the five listed grounds, if a respondent 
presents evidence, either in a written statement or in the context of a 
hearing, I will review the evidence provided by the respondent to 
determine whether revocation or suspension (or denial) is appropriate 
given the particular facts. See 5 U.S.C. 556(d) (``A party is entitled 
to present his case or defense by oral or documentary evidence.''); 21 
CFR 1301.43(c) (permitting a Respondent to file ``a waiver of an 
opportunity for a hearing . . . together with a written statement 
regarding such person's position on the matters of fact and law 
involved in such hearing.''); Jones Total Health Care Pharmacy, LLC v. 
Drug Enf't Admin., 881 F.3d 823, 829 (11th Cir. 2018) (``[W]e may set 
aside a decision as `arbitrary and capricious when, among other flaws, 
the agency has . . . entirely failed to consider an important aspect of 
the problem.' ''); Morall v. Drug Enf't Admin., 412 F.3d 165, 177 (D.C. 
Cir. 2005) (``To uphold DEA's decision, . . . we must satisfy ourselves 
`that the agency ``examine[d] the relevant data and articulate[d] a 
satisfactory explanation for its action including a rational connection 
between the facts found and the choice made.' '').
    Where, as in the instant case, the Government has established a 
ground to deny a registration, I will review any evidence and argument 
the respondent submitted to determine whether or not respondent has 
presented ``sufficient mitigating evidence to assure the Administrator 
that [he] can be trusted with the responsibility carried by such a 
registration.'' Samuel S. Jackson, D.D.S., 72 FR 23,848, 23,853 (2007) 
(quoting Leo R. Miller, M.D., 53 FR 21,931, 21,932 (1988)). `` 
`Moreover, because ``past performance is the best predictor of future 
performance,'' ALRA Labs, Inc. v. DEA, 54 F.3d 450, 452 (7th Cir. 
1995), [the Agency] has repeatedly held that where a registrant has 
committed acts inconsistent with the public interest, the registrant 
must accept responsibility for [the registrant's] actions and 
demonstrate that [registrant] will not engage in future misconduct.' '' 
Jayam Krishna-Iyer, 74 FR 459, 463 (2009) (quoting Medicine Shoppe, 73 
FR 364, 387 (2008)); see also Samuel S. Jackson, D.D.S., 72 FR at 
23,853; John H. Kennnedy, M.D., 71 FR 35,705, 35,709 (2006); Prince 
George Daniels, D.D.S., 60 FR 62,884, 62,887 (1995). The issue of trust 
is necessarily a fact-dependent determination based on the 
circumstances presented by the individual respondent; therefore, the 
Agency looks at factors, such as the acceptance of responsibility and 
the credibility of that acceptance as it relates to the probability of 
repeat violations or behavior and the nature of the misconduct that 
forms the basis for sanction, while also considering the Agency's 
interest in deterring similar acts. See Arvinder Singh, M.D., 81 FR 
8247, 8248 (2016).
    In evaluating the degree required of a respondent's acceptance of 
responsibility to entrust him with a

[[Page 40640]]

registration, in Mohammed Asgar, M.D., the Agency looked for 
``unequivocal acceptance of responsibility when a respondent has 
committed knowing or intentional misconduct.'' 83 FR 29,569, 29,572 
(2018) (citing Lon F. Alexander, M.D., 82 FR 49,704, 49,728). Here, 
Respondent pled guilty to a criminal charge involving intentional 
misconduct--``Receiving in Interstate Commerce a Misbranded Drug with 
Intent to Defraud or Mislead.'' I will, therefore, look for a clear 
acceptance of responsibility from Respondent.
    Respondent took concrete actions to accept responsibility for his 
misconduct while his criminal case was ongoing. He did so by pleading 
guilty to the charge in Federal Court and entering into a settlement 
agreement with the United States of America and the State of Tennessee. 
Respondent's Response to the OSC also states, ``[Respondent] has 
admitted his mistakes and taken responsibility for his actions with his 
freedom and money.'' Response to the OSC, at 6.
    During the pendency of this matter, however, Respondent has not 
made any statements accepting responsibility or expressed remorse for 
his actions. See id. To the contrary, Respondent made arguments in his 
Response to the OSC that deflect or minimize responsibility for his 
actions. In a first-person statement, which he attached as an exhibit 
to his Response to the OSC, Respondent appeared to place the blame for 
the actions leading to his criminal conviction on his clinic's business 
manager. See id. at Ex. 1. In reference to hiring the business manager 
for the clinic, Respondent stated, ``[l]ittle did I know I was sowing 
the seeds of my own destruction. I let [the business manager] do as he 
pleased, not realizing the full extent of the consequences and the 
depth of his treachery.'' Id. I am troubled by this statement and its 
implications for Respondent's acceptance of responsibility.
    Respondent's guilty plea and evidence entered into the record by 
Respondent himself demonstrate that Respondent was not an unknowing and 
naive participant in the scheme that led to his conviction. Respondent 
admitted as part of his plea that clinic nurses raised concerns about 
the misbranded drugs, which led to the clinic doctors deciding to stop 
ordering the drugs. Later, Respondent ``decided McLeod Cancer would 
resume purchasing misbranded unapproved drugs . . . [and that] [t]o 
prevent the nurses from learning that McLeod Cancer was again 
purchasing unapproved foreign drugs, [Respondent] directed [the 
clinic's business manager] to have the drugs shipped to a storage 
business in Johnson City which [Respondent] owned in part.'' RFAAX 3 
(Plea Agreement, U.S. v. William Ralph Kinkaid, No. 2:12-CR-116 (E.D. 
Tenn. June 24, 2013)). Respondent also submitted to the record a letter 
written by an attorney addressing whether Respondent's clinic was 
``breaking federal law by importing foreign prescription drugs for use 
in the United States.'' Response to the OSC, Ex. 3. While the attorney 
greatly downplayed the significance of the legal violation, 
particularly focusing on the lack of enforcement by the Food and Drug 
Administration (hereinafter, FDA) and referencing the importation of 
the drugs as ``a technical violation,'' he did state the FDA could 
enforce if it chose to do so. Id. Respondent decided to resume 
purchasing the misbranded unapproved drugs after receiving this 
opinion.
    Respondent's decision to resume purchasing the misbranded 
unapproved drugs after receiving an opinion that doing so was a 
``technical violation'' that the FDA was unlikely to enforce creates 
concern about whether Respondent can be entrusted with the 
responsibilities of a controlled substances registration. If Respondent 
were to violate part of the CSA that he considered to be a ``technical 
violation,'' based on a perception of limited Agency enforcement, it 
could impact the Agency's mission in preventing the diversion and 
misuse of controlled substances. DEA budgets for approximately 1,625 
Diversion positions involved in regulating more than 1.8 million 
registrants overall.\3\ Ensuring that a registrant is trustworthy to 
comply with all relevant aspects of the CSA without constant oversight 
is crucial to the Agency's ability to complete its mission of 
preventing diversion within such a large regulated population. Jeffrey 
Stein, M.D., 84 FR at 46,974.
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    \3\ See DEA FY2020 Budget Request available at https://www.justice.gov/jmd/page/file/1142431/download.
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    Had there been a hearing on the OSC, it is possible that Respondent 
could have clarified his statements regarding his business manager and 
his reasoning for presenting the private attorney's opinion regarding 
purchasing the misbranded drugs. But with such limited information from 
Respondent, his statements and presentation of the attorney's opinion 
that purchasing the misbranded drugs was a ``technical violation'' 
appear to be aimed at minimizing the egregiousness of his conduct, 
which the Agency has previously weighed against a finding of acceptance 
of full responsibility. See Ronald Lynch, M.D., 75 FR 78,745, 78,754 
(2010) (Respondent did not accept responsibility noting that he 
``repeatedly attempted to minimize his [egregious] misconduct''; see 
also Michael White, M.D., 79 FR 62,957, 62,967 (2014) (finding that 
Respondent's ``acceptance of responsibility was tenuous at best'' and 
that he ``minimized the severity of his misconduct by suggesting that 
he thinks the requirements for prescribing Phentermine are too 
strict.''). In light of Respondent's minimization of his crime and his 
role in the crime, and the lack of a hearing to determine if 
Respondent's previous guilty plea and settlement agreement does, in 
fact, translate to sincere remorse and acceptance of responsibility, I 
cannot characterize Respondent's acceptance of responsibility as 
unequivocal.
    In addition to acceptance of responsibility, the Agency also gives 
consideration to both specific and general deterrence when determining 
an appropriate sanction. Daniel A. Glick, D.D.S., 80 FR 74,800, 74,810 
(2015). Specific deterrence is the DEA's interest in ensuring that a 
registrant complies with the laws and regulations governing controlled 
substances in the future. Id. General deterrence concerns the DEA's 
responsibility to deter conduct similar to the proven allegations 
against the respondent for the protection of the public at large. Id. 
Where a respondent has committed a crime with no nexus to controlled 
substances, it is sometimes difficult to demonstrate that a sanction 
will have a useful deterrent effect. In this case, I believe a sanction 
would deter Respondent and the general registrant community from 
committing ``technical violations'' of the CSA or its implementing 
regulations and thinking that they could do so without serious 
consequence.
    In Respondent's favor, Respondent has been held accountable for 
receiving misbranded drugs with intent to defraud or mislead, having 
been sentenced to prison, paying substantial financial penalties, and 
temporarily losing his medical license. I find that such significant 
consequences are likely to have some deterrent effect on Respondent 
repeating similar misconduct in the future. Additionally, according to 
Respondent's unrebutted claims, he has fully satisfied all requirements 
imposed upon him by the Federal courts and all terms of his settlement 
agreement with the United States of America and the State of Tennessee. 
Response to the OSC, at 3-4. He also satisfied all requirements imposed 
upon him by the state licensing

[[Page 40641]]

authorities to regain his medical license, including at least three 
months of practice under a preceptorship and the completion of forty 
hours of continuing medical education. See Response to the OSC, Ex. 12, 
13. However, it is difficult to determine the amount of deterrence 
these consequences will have on Respondent due to the fact that he 
deflected responsibility for the underlying conduct.
    Finally, Respondent submitted dozens of letters from former 
patients, colleagues, and community members regarding his aptitude as a 
physician and compassionate nature. Response to the OSC, Ex. 14. While 
these character references do not diminish Respondent's bad acts, I 
find the letters to be personal and sincere in their written form. They 
can be of limited weight in this proceeding, however, because I have 
limited ability to assess the actual credibility of the references 
given their written form. See Michael S. Moore, M.D., 76 FR 45,867, 
45,873 (2011) (evaluating the weight to be attached to letters provided 
by the respondent's hospital administrators and peers in light of the 
fact that the authors were not subjected to the rigors of cross 
examination). They also were not written for the purposes of 
recommending that Respondent be granted a controlled substances 
registration, and, therefore, they offer little value in assessing the 
Respondent's suitability to discharge the duties of a DEA registrant. 
Further, absent Respondent's unequivocal acceptance of responsibility, 
what little value the letters might have offered me in evaluating my 
ability to trust Respondent is nullified by the fact that he himself 
has not shown me that he can be so entrusted.
    As discussed above, to receive a registration when grounds for 
denial exist, a respondent must convince the Administrator that his 
acceptance of responsibility and remorse are sufficiently credible to 
demonstrate that the misconduct will not recur and that he can be 
entrusted with a registration. Having reviewed the record in its 
entirety, I find that Respondent has not met this burden. Although 
Respondent did take some responsibility for his actions through his 
guilty plea and settlement agreement with the United States and the 
State of Tennessee, his acceptance of responsibility was not 
unequivocal. Respondent's minimization and deflection of responsibility 
for his criminal conduct raises concern that he would perhaps also be 
willing to circumvent CSA requirements that he deemed ``technical'' to 
the detriment of its effective implementation. I am also concerned that 
granting his registration absent a full acceptance of responsibility 
for his criminal actions would send the message to the registered 
community that they could violate so-called ``technical'' provisions of 
the CSA or its regulations without serious consequence. Unless and 
until Respondent is willing to credibly accept full responsibility for 
his unlawful conduct, I find that I cannot entrust him with a 
controlled substances registration. Accordingly, I will order the 
Agency to deny Respondent's application for a certificate of 
registration.

Order

    Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 
U.S.C. 823, I hereby order that the pending application for a 
Certificate of Registration, Control Number W18085586C, submitted by 
William Ralph Kincaid, M.D., is denied. This Order is effective August 
27, 2021.

Anne Milgram,
Administrator.
[FR Doc. 2021-16004 Filed 7-27-21; 8:45 am]
BILLING CODE 4410-09-P