Notice2021-16004
William Ralph Kinkaid, M.D.; Decision and Order
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Published
July 28, 2021
Issuing agencies
Justice DepartmentDrug Enforcement Administration
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<title>Federal Register, Volume 86 Issue 142 (Wednesday, July 28, 2021)</title>
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[Federal Register Volume 86, Number 142 (Wednesday, July 28, 2021)]
[Notices]
[Pages 40636-40641]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.justice.gov/jmd/page/file/1142431/download">https://www.justice.gov/jmd/page/file/1142431/download</a>.
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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
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</html>Indexed from Federal Register on July 28, 2021.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.